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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Reprod Health
+Journal ID: Reprod Health
+NLM Journal ID: 101224380
+
+Reproductive Health
+
+EISSN: 1742-4755
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12750894
+PMID: 41272728
+DOI: 10.1186/s12978-025-02220-w
+Article ID: 2220
+Article version: 1
+Subjects: Review
+
+A scoping review of the perinatal healthcare experiences of Indigenous childbearing people
+
+Darcha Rosina flo394@usask.ca
+
+Bally Jill M. G.
+Spurr Shelley
+https://ror.org/010x8gc63 grid.25152.31 0000 0001 2154 235X College of Nursing, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, Saskatchewan, S7N 5A4 Canada
+Electronic publication date: 2025 Nov 21
+Publication date: 2025
+Volume: 22
+Electronic Location ID: 264
+Received 2025 Mar 7; Accepted 2025 Nov 11
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Indigenous peoples, Childbearing people, Perinatal healthcare, Healthcare experiences, Indigenous care workers and, Cultural safety
+
+Funding: Saskatchewan Health Research Foundation (SHRF) Not Application Not Application Not Application Darcha Rosina Bally Jill M. G. Spurr Shelley
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2025
+
+Ÿ==============================Ÿ
+Background
+
+Globally, perinatal healthcare access, quality, and outcomes significantly vary between Indigenous and non-Indigenous childbearing people. This situation is precipitated by systemic barriers emanating from the longstanding effects of colonialization. Despite ongoing awareness of culturally safe perinatal care, Indigenous childbearing people continue to have challenging experiences. The purpose of this scoping review was to explore the perinatal healthcare experiences of Indigenous childbearing people to identify research gaps and inform future nursing/midwifery interventions to improve the challenges of engaging in perinatal healthcare in this population.
+
+Methods
+
+The scoping review framework of Arksey and O’Malley was used in this study by searching, retrieving, and analyzing research papers from CINAHL, Ovid/Medline, PsycINFO, PubMed, and Web of Science.
+
+Results
+
+Thirteen peer-reviewed articles published between 2002 and 2021 were analyzed. The experiences of Indigenous childbearing people who sought care during the perinatal period had their experiences classified into positive, negative, complex, and mediating. This scoping review reiterated the need for culturally safe healthcare, preferably delivered by Indigenous healthcare professionals in healthcare facilities situated in Indigenous communities.
+
+Conclusion
+
+It is crucial to further explore the perinatal healthcare experiences of Indigenous childbearing people through in-depth qualitative research to develop culturally safe interventions, especially when life-limiting illnesses or life-threatening illnesses (LLIs/LTIs) occur.
+
+Implications
+
+Overall, completion of this scoping review revealed the need for a comprehensive healthcare system transformation that addresses the needs of childbearing Indigenous families.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12978-025-02220-w.
+
+Background
+
+Globally, perinatal healthcare access, quality, and outcomes significantly vary between Indigenous and non-Indigenous childbearing people [1]. Inequalities related to Indigenous perinatal healthcare access are complex [2, 3], and have been attributed to factors such as colonialism, the residential school system, discrimination, trauma, culture, and socioeconomic status [4–6]. Consequently, Indigenous peoples have been noted to have a deep-seated mistrust of healthcare systems, leading to decreased participation in healthcare [6]. Research has linked this suboptimal perinatal access to poor outcomes such as preterm births, stillbirths, and perinatal deaths [7, 8]. Westernized healthcare systems that are founded on colonial principles have inherent barriers that continue to impact individual perinatal and child health outcomes negatively [4]. These health disparities have precipitated Indigenous people in recent years, to advocate for the integration of culturally safe practices during the perinatal period, which spans from conception through to one-year post-delivery [9]. The concept of cultural safety in nursing was advanced by Irihapeti Merenia Ramsden in 2002 in New Zealand, based on Māori experiences [10]. Cultural safety from the healthcare recipient’s perspective is the decision of whether nursing services are safe for consumption, shifting the appraisal of healthcare from providers to recipients [10]. Irihapeti [10] argues that cultural safety is a matter of social justice, power, bias, and attitudes that affect nursing care, rather than the ethnicity or culture of patients or clients. The cultural safety framework seeks to address health system inequalities by examining concepts such as power, unconscious bias, and institutional racism [10]. Achieving cultural safety would require an understanding of the experiences of this population to develop responsive policies, interventions, and practices by healthcare professionals. A pragmatic step is to review the existing literature to identify gaps, challenges, and experiences of Indigenous childbearing individuals to guide such an understanding. This understanding would necessitate an in-depth evaluation of the existing literature to determine Indigenous childbearing people’s encounters accessing perinatal healthcare, the meaning of quality of care, experiences of discrimination, and perceived barriers to accessing perinatal care. Therefore, a scoping review of the perinatal healthcare experiences of Indigenous childbearing people was conducted.
+
+Methods
+
+Rigorous approaches were adopted to explore the existing literature on Indigenous childbearing people’s experiences seeking perinatal healthcare. Hence, this study was guided by the framework endorsed by Arksey and O’Malley (2005) and includes the following stages: identification of the research question, identification of related studies, charting the data, and collecting, summarizing, and writing the findings [11]. The optional parallel consultation stage recommendation by Arksey and O’Malley [11] was not included because the main aim of conducting this scoping review was to identify knowledge gaps regarding the experiences of Indigenous childbearing people seeking perinatal healthcare in the existing literature, to inform nursing/midwifery practice, education, and policy development. These intentions align with the reasons for executing scoping reviews [11, 12].
+
+Stage 1: identify the research question
+
+To resolve the persisting healthcare disparities confronting Indigenous peoples, several authors have concluded that there is an urgent need to transform mainstream healthcare services at all levels, including policies, physicians, nurses, midwives, support staff, and caring practices [4, 13]. Achieving this transformation would require credible data that describe Indigenous people’s actual perinatal healthcare experiences [9, 14]. Therefore, the purpose of this scoping study was to understand the perinatal healthcare experiences of Indigenous childbearing people. Using the population, concept, and context (PCC) framework recommended by the Joanna Briggs Institute (JBI) [12], the guiding question was as follows: What are the perinatal healthcare experiences of Indigenous childbearing people? This question was broadly framed to obtain depth of coverage of the experiences while retaining focus to guide the search strategy [11]. This carefully developed research question underpinned the systematic exploration of the perinatal healthcare experiences of Indigenous childbearing people to inform future research, education, and possible healthcare intervention development to improve practice. Table S1 outlines the PCC framework that guided this scoping review question (See supplementary file).
+
+Stage 2: identify relevant studies
+
+Developing a thorough search strategy requires planning and expert collaboration to ensure the relevant literature is retrieved. Hence, the corresponding author collaborated with an experienced Health Sciences Librarian to identify relevant concepts and appropriate search terms [11, 12]. A comprehensive list of key search terms and Medical Subject Headings (MeSH) was developed. These were combined with the Boolean operators and used across multiple health science databases. This approach to search strategy development set the foundation for a systematic and replicable review process. Details of the search strategy are presented in Table S2 (See supplementary file). .
+
+Using the developed search strategy presented in Table S2 (See supplementary files), five databases were searched, including Cumulated Index to Nursing and Allied Health Literature (CINAHL), Ovid/Medline, PsycINFO, PubMed, and Web of Science from July 19th to 21 st, 2024. The search was updated on August 6th and 7th, 2025, to ensure any new articles were captured, and a comprehensive search was completed. All these databases have relevant content to help answer the review question, ensuring a comprehensive depth and breadth of the subject area is achieved [11, 12, 15]. To ensure that all relevant studies are captured in this review, an extensive search from the inception of the five databases was done. A search of reference lists, hand searching of related journals, conference resources, Indigenous-specific databases such as the Indigenous Studies Portal (iPortal) of the local university, and website searches were conducted. However, articles found in these searches were already retrieved from the extensive search of the databases [11]. Again, the search for appropriate articles was also guided by clear inclusion and exclusion criteria [11, 12, 15]. Articles included were peer-reviewed and published in the English language; either quantitative, qualitative, or mixed-method in nature; focused on the experiences of Indigenous childbearing peoples during pregnancy, birthing, or postpartum; and the setting of the experiences was either in hospitals, clinics, or community health settings. Articles were excluded if they were not written in English or had an English translation; existing literature reviews, studies focused on non-Indigenous childbearing people, birthing outcomes, and studies in a non-healthcare setting (See Table S3 in the supplementary file).
+
+Stage 3: study selection
+
+A systematic search and screening process to identify relevant studies on the perinatal healthcare experiences of Indigenous childbearing people, using five databases and a joined screening approach was applied. The inclusion and exclusion criteria outlined in Table S2 were strictly observed. The search yielded 10,189 articles across all the databases. These articles were exported from EndNote to the Rayyan software, as recommended by Valizadeh, Moassefi [16], to facilitate a systematic screening process. The other authors (JB and SS) were invited to Rayyan as collaborators.
+
+An initial data-cleaning process identified 775 possible duplicates. These potential duplicates were examined, and 414 articles were confirmed as duplicates and deleted, leaving 9,775 articles for the initial screening. The first author screened the titles and abstracts of the articles while consulting the other authors when needed, ensuring that two of the authors reviewed all articles. This process resulted in the exclusion of 9,756 articles. Thirty-six articles were either included or marked for additional review in the ‘maybe’ folder in Rayyan when the alignment of the article was uncertain for inclusion. To ensure an unbiased study selection process, all three authors screened the 36 articles with Rayyan’s blind feature enabled. The blind was lifted when this phase was completed. The authors met to discuss the articles selected based on the inclusion and exclusion criteria, resulting in 19 articles being selected for full-text screening. Following Peters, Godfrey [12] guidelines, the authors met to discuss the inclusion or exclusion and the rationale for the decisions after completing the full-text screening. Based on consensus, 13 articles were selected and analyzed for this scoping study. Figure 1 is a PRISMA flow chart that illustrates all the stages and the number of articles included or excluded.
+
+Fig. 1 PRISMA Flow Chart of the Study Section Process. Source: Developed using the Shiny app for making PRISMA2020 flow diagrams [17]
+
+Stage 4: charting the data
+
+The extraction and charting of data followed an organized process, utilizing a modified Pinch table to systematically document and analyze the relevant extracted data. In the fourth stage of the Arksey and O’Malley [11] framework for scoping reviews, data were extracted using a structured charting form. The team adapted the Pinch table, a comprehensive data organizational tool introduced by Pinch [18]. This tool presents a rigorous framework for capturing, organizing, and analyzing the data from the 13 articles. The modified Pinch table was used to organize the 13 articles under the following headings: author/year/country; purpose/aim, population/sample; methodology/methods; findings; implications; and future research. To ensure comprehensiveness, the first author completed the initial data extraction. This was followed by several reviews and validation by the other two authors, forming an overview of key data from all the selected studies (See Tables S4a and S4b in the supplementary file). This systematic data charting process ensured the extraction and analysis of relevant data from the included studies, based on which patterns, themes, and gaps in the literature were identified. This process of making meaning of the data extracted did not apply the narrative tradition suggested by [11]. We adopted the analytical process used in recent scoping reviews by [19–21]. This process involves categorization and description of the data to answer the scoping review question [19–21].
+
+Stage 5: Collating, Summarizing, and reporting the results
+
+In this stage, the authors organized and presented the findings without assessing the quality of the articles included, given that this is not necessary for scoping reviews [11, 12, 19]. All authors collaboratively conducted the data analysis by grouping and describing relevant concepts that emerged from the extracted data. This was achieved by following the inductive approach outlined in [21]. The steps adopted include reading and re-reading the extracted data, open coding, developing a coding framework, organizing the extracted data under the coding framework, and categorizing and developing an overarching framework [21]. The categorization of the concepts revealed the existing relationships between them (See Fig. 2), depicting the key patterns in the Indigenous birth givers’ perinatal healthcare experiences outlined by the studies included in this scoping review. This collaborative process of collating, summarizing, and reporting the findings from the 13 studies resulted in a narrative that answered our research question and identified implications for nursing and midwifery research, policy, and practice [15]. Finally, all three authors collaborated in drafting and reviewing the final report.
+
+Rigor
+
+Several steps were taken to ensure rigor in conducting this scoping study. These include involving a Health Sciences Librarian from the outset to ensure a rigorous, valid, and replicable search strategy. Performing a multi-phased screening process in Rayyan with the other two co-authors (JB and SS) as collaborators ensured a non-biased process. The authors held meetings after completing each step of the screening process to discuss the independent selections made. This resulted in an unbiased selection of the 13 articles that explored the perinatal healthcare experiences of Indigenous childbearing people. Furthermore, rigor was maintained by observing the guidelines in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR) [22]. Adhering to appropriate methodological frameworks and guidelines safeguards a systematic method of reviewing existing literature while maintaining academic rigor.
+
+Findings
+
+The scoping review completed permitted the exploration of 13 studies published between 2002 and 2021 related to perinatal healthcare experiences of distinct Indigenous childbearing people across four countries [3, 23–34]. The term “Aboriginal” was used to represent Indigenous peoples from Australia. In Canada, Indigenous peoples include the First Nations (North American Indian), Métis, and Inuit peoples. For this article, the general term “Indigenous” was used apart from the findings from Australia. Most of the studies were conducted in Australia, 61.5% (n = 8). The rest were conducted in Canada (n = 3), New Zealand (n = 1), and the United States of America (n = 1). The studies explored the experiences of the following Indigenous populations: Australian Aboriginal and Torres Strait Islander people [25–30, 32, 33], the Māori people of New Zealand [23], the Mi’kmaq, Haida, Kwakwaka’wakw, and Nuxalk First Nations people of Canada [3, 31, 34], and the American Lumbee Indians [24]. The population mainly studied was women/childbearing people 76.9% (n = 10) [3, 25–29, 31–34]. Additional studies included 15.4% (n = 2) women/parent-infant dyads [24, 30] and 7.7% (n = 1) family unit [23].
+
+Methodologically, the majority, 84.6% (n = 11), used qualitative designs, employing semi-structured interviews, and various Indigenous research approaches. The remaining 15.4% (n = 2) studies used population-based quantitative methods. Of these two quantitative studies, Brown, Gartland [30] adopted the Measure of Indigenous Racism Experience (MIRE), a tool for assessing self-reported racism developed by Paradies and Cunningham [35]. However, the other study by Brown, Weetra [29] did not explicitly specify the tool used for data collection. The studies highlighted a range of perinatal healthcare experiences, including positive, negative, and mediating, with a few studies presenting additional complexity of life-limiting illnesses (LLIs) or life-threatening illnesses (LTIs) such as preterm births [23, 24].
+
+Positive experiences
+
+Indigenous childbearing people recounted different levels of satisfaction with perinatal care, with positive experiences strongly linked to cultural sensitivity, being made to feel special, and holistic support systems [27, 28, 32]. Seear, Spry [27], Watson, Hodson [28], Homer, Foureur [32] documented particularly encouraging experiences, while Brown, Fereday [25] found mainly physical and clinical care satisfaction, with emotional needs often unmet. Support emerged as vital to the positive experiences of Indigenous childbearing people. These supports were from either the family, community, or healthcare workers [23, 25–28, 32–34]. Indigenous healthcare workers such as midwives were noted to improve these experiences [26, 29, 32], as did good client-clinician communication, being made to feel important, and shared decision-making were highly recommended [25–28, 32, 33]. These participants described good communication and shared decision-making as being included in clinical discussions using simple, clear language, face-to-face communication, and receiving regular updates on what is happening in their care to make informed decisions. The Aboriginal Family Birthing Program (AFBP) and Malabar Community Midwifery Link Service, both Australian initiatives that ground perinatal care in Aboriginal culture, were cited as examples of tailor-made perinatal services. This is because participants said they received culturally safe care, had a trusting relationship with care providers who advocated for them, continuity of care, and easily accessible care that successfully integrated traditional practices and provided much-needed social support [29, 32].
+
+These positive findings demonstrate that perinatal healthcare offered through culturally grounded ways, relationship-centered care, and prioritizing Indigenous voices, values, and traditions not only enhance care satisfaction but also serves as an ideal model for transforming healthcare delivery that facilitates equitable and respectful perinatal healthcare for Indigenous people.
+
+Negative experiences
+
+Indigenous participants faced substantial perinatal healthcare challenges in the form of systemic discrimination, cultural insensitivity, and communication barriers [30, 31, 34]. According to the studies, the Aboriginal childbearing people encountered racism and discrimination [30, 31, 34, 36], which was attributed to the medical staff’s poor cultural awareness [25, 28]. This limited cultural insight was demonstrated by hostile hospital policies, which create an environment that marginalizes Indigenous childbearing people’s traditional practices [23, 26, 31]. Communication breakdowns were common, and healthcare workers’ lack of cultural awareness fostered misunderstandings that caused fear among Indigenous clients [3, 25, 28, 33], adversely affecting their access to perinatal care [3, 25, 29, 30]. Furthermore, the experience of ‘shame’ emerged as a deterrent to Indigenous childbearing people’s engagement with healthcare systems [26, 28, 33]. These systemic challenges directly impacted health outcomes, as discrimination was linked to low birth weight among the participants [30]. Other compounding factors were structural inequalities like staff shortages, limited Aboriginal healthcare providers, and broader socioeconomic health disparities [27, 29–31, 34]. Brown, Varcoe [31], Minniecon, Parker [33], and Varcoe, Brown [34] reported that Indigenous childbearing people described perinatal services that were discontinuous and characterized by a lack of control and choice. The participants said health workers were trying to be helpful, but were experienced as very ‘pushy’ [33]. Geographical barriers to care, led to forced evacuation, often separating birth givers from their families, loved ones, and other children for long durations while seeking perinatal healthcare [31, 34].
+
+The barriers experienced by the childbearing people in the studies included in this scoping review, ranged from discriminatory attitudes and a lack of cultural safety to geographical isolation and systemic inequalities, collectively creating a healthcare atmosphere that potentially compromised their physical and mental health outcomes.
+
+Complex experiences
+
+Indigenous childbearing people going through high-risk perinatal complications, such as preterm births, experience emotional and health system challenges that disrupt traditional caregiving. Researchers including Burns, Whitty-Rogers [3], Brown, Weetra [29], noted that increased stress levels during such complications are associated with perceived discrimination. Perceived discrimination adversely affected healthcare experiences during these unexpected upheavals [23, 24]. To cope with the chaos at this time, Indigenous parents tend to rely on cultural practices such as burying the placenta, ‘smudging’, and traditional medicines [23, 27], which were often not supported by health facility policies [23, 24, 27].
+
+Indigenous parents in the Neonatal Intensive Care Unit (NICU) reported several challenges, including: Navigating complex hospital admission protocols, receiving inadequate medical information, and managing contradicting clinical directives [23, 24]. Also, parents’ ability to bond with their infants was hindered by emotional disturbances like loneliness, fear, frustration, powerlessness, and guilt [23, 24]. This is worsened by restrictive hospital policies that prevent holding their babies in the NICU and restricted visiting hours [23, 24, 31]. According to Brooks, Holdtich-Davis [24], some parents developed symptoms of post-traumatic stress disorder (PTSD) that persisted after discharge from the NICU. Brown, Varcoe [31] and Varcoe, Brown [34] described participant experiences of feeling stressed, depressed, and in some cases, developed postpartum depression. Caregivers said they often failed to perform important cultural newborn ceremonies like naming and navigating a balance between traditional and Western medical practices [24].
+
+The combination of high-risk perinatal complications and systemic healthcare barriers led to a dual crisis for Indigenous families who participated in the research included in this scoping review [23, 24]. Medical emergencies not only threatened physical health but also disrupted important cultural practices and traditional healing ways, leaving parents to navigate trauma and recovery within an unsupported environment.
+
+Mediating experiences
+
+Through the completion of this scoping review, it was revealed that globally, there is an urgent need for healthcare systems that are culturally safe and responsive to the perinatal healthcare needs of Indigenous childbearing people. To achieve this, participants made suggestions that could enhance positive experiences or resolve negative or complex experiences during the perinatal period. Participants across all the studies wanted healthcare providers to acknowledge and respect their cultural identity [24], thereby providing perinatal care that is culturally safe and appropriate for their needs [3, 23–30].
+
+Such a model of Indigenous-appropriate perinatal care to promote access could only be developed by seeking the views of Indigenous childbearing people, Elders, and community members [3, 28, 31]. Training clinicians to comprehend cultural safety [3, 27, 30] would help them understand the health experiences of Indigenous childbearing people [26]. Fostering health professionals’ cultural understanding would enable trusting relationships with Indigenous clients, which emerged in the literature as key to positive experiences of care [23, 26, 27, 32]. Furthermore, it was documented that training and recruiting Indigenous midwives or perinatal care workers to care for Indigenous childbearing people was noted as vital to culturally safe care [25, 27, 29, 32]. Siting perinatal health facilities in Indigenous communities has been presented as a feasible solution to improving perinatal care experiences [28]. Watson, Hodson [28] also suggested closing the gap due to the social determinants of health inequalities by offering resources tailored to the needs of the targeted Indigenous population.
+
+These improvements can only be achieved by filling the knowledge gap through future research evidence that seeks to understand the nuances of Indigenous cultures, spirituality, lifestyle, healthcare experiences, and discrimination. This is critical to minimizing some of the challenges noted in this scoping review. Generating such knowledge would, ultimately, inform policies that promote the integration of Indigenous cultures into perinatal care [3, 23–27, 30]. Perinatal care models that meet the needs of Indigenous childbearing people could be developed by promoting cultural understanding, Indigenous-led research, and strategies to address systemic barriers to equitable perinatal care. To potentially transform perinatal healthcare for Indigenous families, models of care that are Indigenous-led and community-centered are required. According to the literature reviewed, such a model of care must include approaches that honor traditional knowledge systems, address structural inequalities, be grounded in cultural safety, and yet al.so respect the self-determination priority of Indigenous communities [3, 23–30].
+
+The salient concepts and their relationships, described in the findings above, have been summarized by the authors into a conceptual model, illustrated in Fig. 2. This conceptual model is the outcome of the authors’ analysis and subsequent understanding of the data extracted from the studies included in this scoping review.
+
+Fig. 2 A Conceptual Model Summarizing the Scoping Review Findings. Source: Authors’ Construct (2024)
+
+Discussion
+
+The purpose of this scoping review was to identify the knowledge gap in the literature regarding the perinatal healthcare experiences of Indigenous childbearing people. The authors conducted a broad search and included 13 studies that met the inclusion and exclusion criteria. The included studies provided valuable insight into understanding this important topic. Findings from the literature revealed that participants had interrelated positive, negative, complex, and mediating encounters with the healthcare system and professionals. This evidence highlights the need for future nursing/midwifery research, interventions to improve nursing care practices, and education or training on cultural safety. These results illustrate the multifaceted nature of the perinatal healthcare encounters of Indigenous birth givers and health professionals [37, 38].
+
+The positive experiences of participants, although relatively less common occurrences, present strategies for health workers to enhance perinatal care for Indigenous childbearing people. The ability to recognize and respect Indigenous cultural identity was the foundation of the participant’s positive experiences. Key to positive experiences is promoting support from family and loved ones; building trusting relationships with clinicians; providing culturally safe care; good staff-client communication that ensures clients’ full participation in their care; and training and recruiting Indigenous health professionals conversant with Indigenous childbearing culture. Although these approaches embody care that is culturally safe for Indigenous childbearing people, none of the studies specifically outlined how to achieve these strategies. For example, Brown, Weetra [29] quantitative study proved that the AFBP was culturally safe for Indigenous childbearing people without the depth that a qualitative study would have provided. Similar results were found in earlier studies that noted increased client care satisfaction and access when perinatal care was made culturally safe by incorporating Indigenous practices and care workers in the delivery of services [39, 40]. Nevertheless, this scoping review has illuminated the need to delve deeper to understand how to build trusting relationships or provide culturally safe perinatal care, rather than enumerate what should be done, as is often the case in related studies.
+
+Negative experiences were more prevalent in many of the studies reviewed, and these were described as discrimination, marginalization, racism, lack of Indigenous cultural and spiritual insight, communication barriers, and hostile hospital policies. These challenges are remnants of racism and colonialism persisting in healthcare systems [41]. Other studies have confirmed that Indigenous people endure adverse perinatal experiences like unfair treatment and discrimination [2, 42]. According to Chowdhury [43], the Indigenous childbearing people of Garo reacted to racist experiences by avoiding hospitals as a way of expressing their resistance to racism. In Canada, for example, the persistent access barriers, exacerbated by negative experiences, despite the Truth and Reconciliation Commission’s (TRC) calls to action numbers 18 to 24 on health [44], suggest the existence of considerable implementation gaps in providing culturally safe care for Indigenous people. The TRC of Canada made 94 calls to action to repair the atrocities that occurred for over 100 years in Indian Residential Schools. These calls to action target various sectors of society, of which 18 to 24 target improving the health of Indigenous people in Canada [44]. Following these calls to action, the Government of Canada has implemented several national and provincial programs to improve the perinatal healthcare of Indigenous people [45]. Despite the substantive investment to this effect, corresponding outcomes have not been achieved [46]. The minimal positive results obtained may be explained by the findings from this scoping review, which suggest that the programs were probably implemented without adequate Indigenous consultation and research evidence to guide the processes. This is confirmed by finding a limited number of primary studies that explored the perinatal healthcare experiences of Indigenous people in Canada [22]. Therefore, this scoping review not only confirms the existence of profound negative perinatal healthcare experiences but also highlights a unique population that is yet to benefit from extensive research evidence on perinatal healthcare.
+
+The complex perinatal experiences are obscure in the literature, yet are vital determinants of Indigenous childbearing people’s experiences. In this scoping review, complex experiences identified underscore the additional stressors when LLIs/LTIs such as preterm births occur, defying simple classification of the experiences as positive or negative. This compounds healthcare experiences, ultimately suggesting that some positive experiences could degenerate into negative ones and negative ones may worsen over time. The available related literature only explored the prevalence, risk factors, and outcomes of LLIs/LTIs among Indigenous people [1, 47, 48], with few studies examining participants’ experiences during the perinatal period [23, 24]. It is, therefore, important to explore these experiences in-depth. Specifically, exploring when LLIs/LTIs occur is even more critical because the client-clinician interaction is prolonged, hence the need for robust and practical culturally safe interventions. Health workers can only provide this needed support if adequate data exists to guide the delivery of perinatal healthcare for this unique population.
+
+Mediating experiences emerged as transformational, an intersection between positive and negative experiences. Mediating experiences in this literature review are bidirectional and capable of changing the direction of perinatal healthcare experiences from negative to positive and vice versa, as envisioned in Fig. 2. It is encouraging that mediating factors emerged from the literature to guide stakeholders’ ability to transform the perinatal healthcare landscape of Indigenous childbearing people. The crux of the matter is recognizing Indigeneity, developing inclusive care models, and delivering perinatal care in a culturally safe manner. Two studies have similar findings [2, 39] and recognize the role of intermediaries such as Indigenous midwives, doulas, and cultural support workers of Indigenous origin working in either mainstream health facilities or in the community as transformative approaches to converting negative experiences into positive ones [39]. Despite these similar results, the findings of this scoping review are unique because they present a potentially clear and holistic picture of the perinatal healthcare experiences of Indigenous childbearing people. Not only was the need to further explore the perinatal healthcare experiences of Indigenous childbearing people highlighted, but also the critical nature of understanding the experiences of this population when LLIs/LTIs occur.
+
+Strengths and limitations
+
+Several limitations should be considered when interpreting the findings of this scoping review. First, the studies included were qualitative and quantitative, excluding theoretical literature. Thus, important theoretical perspectives could have been excluded. Second, the inclusion of only articles published in the English language could have excluded valuable literature published in other languages. Third, it is noteworthy that eight of the 13 studies included were conducted in Australia, indicating that the experiences described might differ culturally from those in the other three countries, limiting the transferability of some findings. However, it is likely that readers will find meaning and usefulness from review of the findings of this scoping review. The results from the 13 studies included in this review might not be enough to comprehensively depict all the perinatal healthcare experiences of Indigenous childbearing people seeking healthcare. Finally, it is also possible that relevant articles may not have been included even though a thorough search was completed with the assistance of an experienced health sciences librarian. However, the findings are still valuable and provide a basis for future research to inform nursing and midwifery education, research, policy, and practice.
+
+Conclusion
+
+This scoping review explored the perinatal healthcare experiences of Indigenous childbearing people globally. Thirteen articles that overtly described the participants’ healthcare experiences were analyzed. The gap in the limited number of published articles on this important research topic, despite a thorough literature search, reiterates the need for this scoping review. Individually, each study outlined the perinatal healthcare experiences from multiple diverging perspectives. However, this scoping review organized the results into four categories: Positive, negative, complex, and mediating experiences. Organizing the results from the 13 included studies into these categories led to findings that are unique, holistic, and provide an understanding of the experiences of Indigenous childbearing peoples. Furthermore, the findings offer potential solutions to improve these experiences by emphasizing cultural safety. This implies recognizing and integrating cultural safety practices into mainstream perinatal healthcare; hence, the need for healthcare systemic changes. The preference for culturally safe care may necessitate an increased representation in the Indigenous healthcare workforce. Formulating meaningful policies, interventions, and training a capable Indigenous workforce would require knowledge and understanding of these experiences through an in-depth qualitative study to generate data that could be directly applied to practice. Finally, a hidden but critical area that emerged from the literature is the complex experiences associated with the presence of LLIs/LTIs during the perinatal period. These experiences defy classification yet are powerful enough to consider changing the direction of the perinatal healthcare experiences of Indigenous childbearing people. Overall, these findings are all compelling in answering the scoping review question and highlighting the crucial need for an in-depth qualitative exploration of this study area.
+
+Supplementary Information
+
+Supplementary Material 1.
+
+Abbreviations
+
+AFBP Aboriginal Family Birthing Program
+
+CINAHL Cumulated Index to Nursing and Allied Health Literature
+
+JBI Joana Briggs Institute
+
+LLIs Life-Limiting Illnesses
+
+LTIs Life-Threatening Illnesses
+
+MeSH Medical Subject Headings
+
+NICU Neonatal Intensive Care Unit
+
+PCC Population Concept and Context
+
+PRISMA-ScR Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews
+
+PTSD Post-traumatic stress disorder
+
+TRC Truth and Reconciliation Commission
+
+Acknowledgements
+
+We wish to acknowledge the support received from Catherine Boden, a Health Science Librarian, in refining the search strategy and assistance in searching the databases.
+
+Authors’ contributions
+
+All the authors, RD, JB, and SS, collaborated to develop the scoping review topic. RD searched the databases and completed the title and abstract screening while consulting JB and SS as needed. Full-text screening was completed by all the authors RD, JB, and SS. RD drafted the manuscript and engaged with JB and SS to review, edit, and approve the final manuscript submitted.
+
+Funding
+
+This scoping review was supported by funds from the Saskatchewan Health Research Foundation (SHRF) and the Canada Institute for Health Research/Saskatchewan Centre for Patient-Oriented Research (CIHR/SCPOR). The funders did not take part in the conceptualization, design, data collection, analysis, decision to publish, or preparation of this manuscript.
+
+Data availability
+
+No datasets were generated or analysed during the current study.
+
+Declarations
+
+Ethical approval and consent to participate
+
+Not Applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+Jill M. G. Bally and Shelley Spurr contributed equally to this work.
+
+
+References
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+Brown SJ, Yelland JS, Sutherland GA, Baghurst PA, Robinson JS. Stressful life events, social health issues and low birthweight in an Australian population-based birth cohort: challenges and opportunities in antenatal care. BMC Public Health. 2011;11(1):196. 10.1186/1471-2458-11-196.21450106 10.1186/1471-2458-11-196 PMC3080815
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+Carlin E, Cox Z, Spry E, Monahan C, Marley JV, Atkinson D. When I got the news: aboriginal fathers in the Kimberley region yarning about their experience of the antenatal period. Health Promot J Aust. 2021;32(3):513–22. 10.1002/hpja.375.10.1002/hpja.375 PMC8359486 32589308
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+Silver H, Sarmiento I, Pimentel J-P, Budgell R, Cockcroft A, Vang ZM, et al. Childbirth evacuation among rural and remote Indigenous communities in canada: A scoping review. Women Birth. 2022;35(1):11–22. 10.1016/j.wombi.2021.03.003.33714690 10.1016/j.wombi.2021.03.003
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+McNeil D, Elliott SA, Wong A, Kromm S, Bialy L, Montesanti S, et al. Indigenous maternal and infant outcomes and women’s experiences of midwifery care: A mixed-methods systematic review. Birth. 2024;0(0):1–16. 10.1111/birt.12841.10.1111/birt.12841 PMC12060610 38898696
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diff --git a/corpus/healthcare/text/0b9728e6a22974fd.txt b/corpus/healthcare/text/0b9728e6a22974fd.txt
new file mode 100644
index 0000000000000000000000000000000000000000..112a8409a76b35e965310668a8204ea78afcf514
--- /dev/null
+++ b/corpus/healthcare/text/0b9728e6a22974fd.txt
@@ -0,0 +1,55 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Sci Rep
+Journal ID: Sci Rep
+NLM Journal ID: 101563288
+
+Scientific Reports
+
+EISSN: 2045-2322
+Publisher: Nature Publishing Group
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13469104
+PMID: 42586996
+DOI: 10.1038/s41598-026-64932-8
+Article ID: 64932
+Article version: 1
+Subjects: Correction
+
+Correction: Negative pressure wound therapy promotes wound healing of diabetic foot ulcers by up-regulating PRDX2 in wound margin tissue
+
+Tang Ying 1
+Liu Lei 1
+Jie Ruyan 1
+Tang Yizhong 2
+Zhao Xiaotong 1
+Xu Murong crystally@foxmail.com
+1
+Chen Mingwei chmw1@163.com
+1
+1 https://ror.org/03t1yn780 grid.412679.f 0000 0004 1771 3402 Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, No.218 Jixi Road, Shushan District, Hefei City, Anhui Province People’s Republic of China
+2 https://ror.org/03t1yn780 grid.412679.f 0000 0004 1771 3402 Department of Burns, The First Affiliated Hospital of Anhui Medical University, Hefei City, Anhui Province People’s Republic of China
+Electronic publication date: 2026 Aug 12
+Publication date: 2026
+Volume: 16
+Electronic Location ID: 25116
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Negative pressure wound therapy promotes wound healing of diabetic foot ulcers by up-regulating PRDX2 in wound margin tissue 13 27 9 2023 16192 Scientific Reports 10.1038/s41598-023-42634-9 PMC10533814 37758743
+issue-copyright-statement: © Springer Nature Limited 2026
+
+Ÿ==============================Ÿ
+Correction to: Scientific Reports 10.1038/s41598-023-42634-9, published online 27 September 2023
+
+The original version of this Article contains errors in panel C of Figure 3.
+
+As a result of an oversight during figure assembly, the images for HG + OE-PRDX2 and NG + si-PRDX2 group are partially overlapped.
+
+The correct Figure 3 and accompanying legend appear below.Fig. 3 Effect of PRDX2 on proliferation, migration, and apoptosis of NHDF cells. (A) The mRNA expression levels of PRDX2 by qRT-PCR in NHDF cell under different conditions. (B) Cell proliferation was monitored by CCK8 assay. (C and D) Cell migratory capability was measured by Transwell assay and wound healing assay. (E) Cell apoptosis was measured by flow cytometry (Annexin V-PI); versus NG + Si-NC, #P < 0.05; versus HG + Si-NC, *P < 0.05; versus NG + si-PRDX2, &P < 0.05; versus NG + OE-NC, ▲P < 0.05; versus HG + OE-NC, ■P < 0.05; versus NG + OE-PRDX2, □P < 0.05.
+
diff --git a/corpus/healthcare/text/0ba296348b4e25eb.txt b/corpus/healthcare/text/0ba296348b4e25eb.txt
new file mode 100644
index 0000000000000000000000000000000000000000..77036f409c1dead8d122b0d2584941925778f90e
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+++ b/corpus/healthcare/text/0ba296348b4e25eb.txt
@@ -0,0 +1,598 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Nurs Open
+Journal ID: Nurs Open
+NLM Journal ID: 101675107
+Journal ID: NOP2
+
+Nursing Open
+
+EISSN: 2054-1058
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12012308
+PMID: 40259795
+DOI: 10.1002/nop2.70211
+Article ID: NOP270211
+Article ID: NOP-2024-Sep-2069.R2
+Article version: 1
+Subjects: Systematic Review, Systematic Review
+
+Prodromal Symptoms of Acute Myocardial Infarction in Women: A Systematic Review of Current Evidence
+
+Giordano Vincenza https://orcid.org/0009-0001-7625-5240 vincenza.giordano@alumni.uniroma2.eu
+1
+Nocerino Rita https://orcid.org/0000-0003-4681-546X 1 2 3 rita.nocerino@unina.it
+
+Mercuri Caterina c.mercuri@unicz.it
+4
+Rea Teresa https://orcid.org/0000-0001-6444-0951 teresa.rea@unina.it
+5
+Guillari Assunta https://orcid.org/0000-0001-8423-8195 assunta.guillari@unina.it
+2
+1 Department of Biomedicine and Prevention University of Rome Tor Vergata Rome Italy
+2 Department of Translational Medical Science Federico II University Hospital Naples Italy
+3 ImmunoNutritionLab, CEINGE‐Advanced Biotechnologies University of Naples “Federico II” Naples Italy
+4 Department of Experimental and Clinical Medicine Magna Graecia University of Catanzaro Catanzaro Italy
+5 Public Health Department Federico II University Hospital Naples Italy
+* Correspondence:
+Rita Nocerino (rita.nocerino@unina.it)
+
+Electronic publication date: 2025 Apr 22
+Publication date: 2025 Apr
+Volume: 12
+Issue: 4
+Electronic Location ID: e70211
+Revised 2025 Feb 19; Received 2024 Oct 2; Accepted 2025 Mar 27
+Copyright: © 2025 The Author(s). Nursing Open published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: acute coronary syndrome, acute myocardial infarction, prodromal symptom, woman
+Figure count: 1
+Table count: 3
+Page count: 17
+
+source-schema-version-number: 2.0
+cover-date: April 2025
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.5.5 mode:remove_FC converted:22.04.2025
+
+Funding: The authors received no specific funding for this work.
+
+Rita Nocerino and Caterina Mercuri contributed equally to this study.
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Aim
+
+To synthezise quantitative current evidence on the prodromal symptoms experienced by women before the onset of acute coronary syndrome (ACS), focusing on the prevalence, nature and clinical implications of these symptoms.
+
+Design
+
+A systematic review.
+
+Methods
+
+The review adhered to Synthesis without meta‐analysis guidelines and was registered with the PROSPERO database (ID: CRD42024541840). Systematic searches were conducted in PubMed, CINAHL, APA PsycArticles, APA PsycInfo and EMBASE. Included studies were quantitative, focused on women aged ≥ 18 years with confirmed acute coronary syndrome and reported prodromal symptoms. The Quality Assessment with Diverse Studies and the Cochrane Risk of Bias in non‐randomized studies of Interventions tools were used for critical appraisal.
+
+Results
+
+Of 2170 identified records, 11 full‐text studies were reviewed. The most frequently reported prodromal symptom was unusual fatigue, followed by sleep disturbances and anxiety. Prodromal symptoms often occurred well before the acute event but were frequently misattributed to non‐cardiac causes. Chest pain, typically associated with acute coronary syndrome, was less commonly reported as a prodromal symptom in women, complicating timely diagnosis and treatment.
+
+Conclusions
+
+The results highlight the need for increased awareness of these early warning signs among healthcare providers and women themselves. Enhanced recognition and understanding of these symptoms could lead to more timely and accurate diagnosis, ultimately improving outcomes for women at risk of acute myocardial infarction.
+
+Implications for the Profession and/or Patient Care
+
+To educate both health professionals and patients about the variability and significance of prodromal symptoms in women is essential to improve outcomes.
+
+Impact
+
+This study is the first to systematically review and synthesize the existing literature on prodromal symptoms of acute coronary syndrome specifically in women. The results show l that women are more likely to experience a broader and more complex range of prodromal symptoms, including fatigue, sleep disturbances and anticipatory anxiety, which often precede the acute event. The insights provided by our review could lead to significant improvements in the early diagnosis and treatment of AMI in women, ultimately reducing morbidity and mortality rates associated with cardiovascular diseases.
+
+Reporting Method
+
+The review has adhered to relevant EQUATOR guidelines and has followed Synthesis without meta‐analysis guidelines.
+
+Patient or Public Contribution
+
+No patient or public contribution.
+
+1 Introduction
+
+Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality among women, yet it is often underdiagnosed, undertreated and under‐researched, particularly concerning the prevention, diagnosis and treatment of heart disease (Vogel et al. 2021). Among the various forms of CVD, ischaemic heart disease is the most prevalent and deadly, with an estimated 197 million cases and 9.14 million deaths globally (Rodriguez Lozano et al. 2022). While men account for 114 million cases, women represent 83.6 million cases, with a mortality rate of 4.17 million, highlighting a significant gender disparity in both prevalence and outcomes (Roth et al. 2020). In Europe, ischaemic heart disease accounts for 40% of cardiovascular deaths in women, underscoring the critical need for targeted interventions (Townsend et al. 2022).
+
+Ischaemic heart disease includes acute myocardial infarction (AMI) with non‐obsctructive coronary artery disease (MINOCA) and non‐obstructive ischaemia and coronary artery disease (INOCA) (Vogel et al. 2021; Pacheco et al. 2022). A significant subset of ischaemic heart disease is represented by acute coronary syndrome (ACS), a term used to describe a group of conditions caused by sudden, reduced blood flow to the heart. ACS encompasses ST‐elevation myocardial infarction (STEMI), non‐ST‐elevation myocardial infarction (NSTEMI) and unstable angina, which are distinguished by their severity and clinical presentation. ACS is often caused by the rupture of an atherosclerotic plaque, resulting in partial or complete obstruction of coronary blood flow (Singh et al. 2023).
+
+Women with AMI often experience intermittent symptoms that may last for hours, days or weeks before the acute event. Although chest pain is the most common symptom, women often present more heterogeneous symptoms of AMI (Cardeillac et al. 2022). Indeed, symptoms such as breathing difficulties, digestive problems and fatigue have traditionally been defined as ‘atypical’. However, this classification of ‘atypicality’ has been questioned over the years, as it is increasingly believed that the variability of symptoms is influenced by gender (DeVon et al. 2020; Cardeillac et al. 2022). In addition, the variability and intermittency of these symptoms may lead to misinterpretation of AMI by both patients and healthcare professionals, hindering early recognition and often leading to misdiagnosis (Lichtman et al. 2015; Birnbach et al. 2020).
+
+The focus on prodromal symptoms of AMI dates to the 1930s (Feil 1937). Prodromal symptoms are generally considered warning signs of an impending ACS. They represent the early stages of heart disease and tend to be short‐lived, less intense, transient and non‐specific compared to unstable angina (O'Keefe‐McCarthy and Ready 2016). These symptoms lack specific features, are transient, indicative of an impending ACS and may occur days to several weeks before an adverse cardiac event (O'Keefe‐McCarthy and Ready 2016). Initially, in fact, studies such as Nixon and Bethell (1974) underscored the importance of symptoms like fatigue and pain as early indicators of AMI, yet they did not account for gender differences; later research, then, has explored this aspect more thoroughly, demonstrating a broader spectrum of prodromal symptoms in women. For example, Hofgren et al. (1995) study found that 70% of women reported symptom onset before hospital admission. More specifically, a study by McSweeney and Crane (2000) involving 40 women with AMI revealed that 92.5% reported at least one prodromal symptom, with 87.5% experiencing three or more symptoms, which manifested 4–6 months prior to the event.
+
+According to Rosenfeld (2001), the severity of symptoms and their slow or intermittent progression are crucial clinical factors predicting delays in seeking medical attention among women; Kirchberger et al. (2011) report that the female sex is associated with a higher risk of misinterpreting the symptoms of AMI: women not only fail to exhibit the typical symptoms of AMI (Kirchberger et al. 2011), but often do not perceive themselves to be at risk for AMI (Lichtman et al. 2015). In addition, they tend not to associate their symptoms with a cardiac problem, but rather with anxiety and stress, and react to the event in different ways (Buckley et al. 2007; Kirchberger et al. 2011). Not only women but also healthcare professionals show delays and inconsistencies in responding to prodromal symptoms (Lichtman et al. 2015). Such behaviors can lead to delays in seeking care, with potential negative consequences for the effectiveness of treatment or on the timing of interventions (Kirchberger et al. 2011; Lichtman et al. 2015). Bahr et al. (2001) emphasized that early recognition of prodromal symptoms of AMI is a critical but often neglected and underestimated issue that could benefit from targeted educational interventions for both patients and healthcare providers. To date, there have been no systematic reviews of the quantitative evidence, but there has been an integrative review by Blakeman and Booker (2016).
+
+Existing reviews in the literature focus on prodromal symptoms across both sexes, investigate a single prodromal symptom in women, assess prodromal and acute symptoms together or explore these symptoms in relation to risk factors. For instance, Miller's (2002) review explored qualitative and quantitative studies on cardiac warning symptoms in women, while Blakeman and Stapleton (2018) conducted an integrative review addressing the severity, discomfort, quality and timing of prodromal AMI fatigue in women, offering recommendations for clinical practice and future research. In contrast, Schulte and Mayrovitz (2023) conducted a systematic review analysing differences in symptoms and pathophysiology of AMI between women and men, and Bruyninckx et al. (2008) focused on the accuracy of 10 signs and symptoms in both genders with AMI and ACS.
+
+Therefore, a systematic review is urgently needed to consolidate the current evidence and improve our understanding of the unique prodromal symptomatology of ACS in women, thereby improving diagnostic accuracy and patient outcomes.
+
+2 Aim of Study
+
+The aim of this systematic review is to synthesize and critically analyze the existing quantitative evidence on the prodromal symptoms experienced by women before to the onset of ACS.
+
+3 Design and Methods
+
+3.1 Design
+
+This systematic review was conducted following the Synthesis without meta‐analysis (SWiM) (Campbell et al. 2020). This structured approach enabled a comprehensive and methodical analysis of literature. It focused on identifying, selecting, evaluating and synthesising data related to prodromal symptoms of AMI in women. The protocol of the systematic review was registered in the PROSPERO database. The registration number was CRD42024541840.
+
+3.2 Data Sources and Search Strategies
+
+This systematic review was conducted using a rigorous, evidence‐based approach. We hypothezised that women experience prodromal symptoms in the days before an ACS. The research question for this systematic review was ‘What are the most common prodromal symptoms reported by women diagnosed with acute coronary syndrome?’ The population, intervention, outcome (PIO) framework was utilized to identify keywords and MeSH terms that included: the target population (women with ACS), interventions (symptom recognition) and outcomes (prodromal symptoms). Relevant publications were identified by systematic data searches from March to June 2024 in the following electronic databases: Pubmed, CINAHL, APA PsycArticles, APA PsycInfo, EMBASE. Combinations of the following medical key words were used: “woman,” “female,” “prodromal symptoms,” “early warning,” “premonitory symptoms,” “acute coronary syndrome,” “acute myocardial infarction,” “heart attack,” “ischemic heart disease” and “acute disease.” In each database, synonyms were identified for each Medical Subject Heading (MeSH) term. Advanced search strings were created using Boolean operators such as OR and AND to cross‐reference these terms in various combinations to increase the specificity of the search (Supporting Information).
+
+It is important to note that no filters were applied to the database searches. The formulation of keywords and MeSH terms was a collaborative effort involving all authors to meet validity criteria and reduce search bias. Similary, the authors collaborated in the retrieval of studies and full texts and jointly assesed them to identify reports relevant to the research topic. The research team reviewed the titles and the abstracts. No date restrictions were applied when searching for articles in the databases.
+
+3.3 Selection Criteria
+
+To be eligible for inclusion, studies were subjected to the following inclusion criteria: Primary quantitative studies;
+
+Studies in adult female populations (≥ 18 years) with a confirmed diagnosis of acute coronary syndrome (ACS), including ST‐segment elevation myocardial infarction (STEMI), non‐ST‐segment elevation myocardial infarction (NSTEMI) or unstable angina, who presented prodromal symptoms;
+
+Studies that numerically described one or more specific prodromal symptoms of myocardial infarction or a group of symptoms experienced by women;
+
+English‐language studies only.
+
+The studies were excluded based on the following criteria: Secondary and qualitative studies;
+
+Editorial reviews and/or letters to the editor;
+
+Dissertations;
+
+Studies in which there is complexity in sampling adult women (≥ 18 years) with a confirmed diagnosis of acute myocardial infarction who have prodromal symptoms;
+
+Studies in which it is difficult to identify or extract prodromal symptoms (e.g., studies that examine both prodromal and acute symptoms);
+
+Studies that did not report a specific focus on prodromal symptoms;
+
+Studies in languages other than English.
+
+In this review, no temporal limits were applied to the presentation of prodromal symptoms of the acute event.
+
+3.4 Study Screening and Data Extraction
+
+The selected studies were uploaded to the Rayyan platform (https://www.rayyan.ai) for preliminary screening.
+
+Three reviewers (V.G., C.M., A.G.) performed the screening and selection of these studies. After duplicates were eliminated, three investigators (V.G., C.M., A.G.) independently assessed study titles and abstracts from five databases to exclude irrelevant studies based on the eligibility criteria. In the next step, the researchers assessed the remaining study types and accessed the full texts of potentially relevant studies. Discrepancies in study inclusion were resolved by discussion with a fourth reviewer (R.N.). From the final 11 studies, data were extracted and independently reviewed by three researchers (V.G., C.M., A.G.). The eligibility of the studies for inclusion in the review was determined by consensus of all authors. The screening process is illustrated in the PRISMA diagram (Figure 1) (Page et al. 2021).
+
+FIGURE 1 PRISMA flow diagram.
+
+3.5 Data Synthesis and Evaluation
+
+After the identification of the literature to be included in the review, the studies were read once to gain a general understanding of the body of literature . Three authors (V.G., C.M., A.G.) independently extracted data, including the author, year of publication, study purpose, sample size and demographics, outcome measures, instruments or scales used, study methodology, statistical analyses, results relevant to the research question and including any limitations noted.
+
+Several critical factors made a meta‐analysis impossible, as it would have compromised the methodological integrity. Significant heterogeneity was observed among the studies in terms of research designs and study populations. Differences in sample sizes and methodologies limited the generalizability of the results and posed challenges in pooling data for a meta‐analysis. Variability in the scales and metrics used to assess outcomes further complicated the analysis.
+
+Given these considerations, the review team concluded that a meta‐analysis was not feasible due to the heterogeneity of the data and therefore opted for a narrative synthesis to provide a comprehensive overview of prodromal symptoms in women prior to the diagnosis of AMI. This approach allows for a qualitative exploration of literature, acknowledging its complexity and variation, yet providing valuable insights. Due to the heterogeneity among the examined studies, the studies were grouped by types of prodromal symptoms reported by women: anxiety, fatigue, sleep disturbance, changesperformed in thinking and memory, dyspnea and respiratory problems, gastrointestinal symptoms, headache, other prodromal symptoms and pain.
+
+3.6 Quality Assessment
+
+The methodological quality of included studies was critically appraised in pairs using the Quality Assessment with Diverse Studies (QuADS) (Harrison et al. 2021) (Table 1). QuADS is an evolution of the quality assessment tool for studies with diverse designs (QATSDD) originally developed by Sirriyeh et al. (2012). The QuADS is an appraisal tool developed to determine the methodological and reporting quality of mixed‐ or multi‐method studies included in systematic reviews. The QuADS is designed to leverage survey data and literature review findings, thereby increasing its relevance to health services research, particularly for studies using mixed or multiple methods. Its widespread adoption underscores the value researchers place on the ability to assess the the quality of evidence from studies that use or combine different methods.
+
+TABLE 1 Quality appraisal: Quality assessment with diverse studies (QuADS) (Harrison et al. 2021).
+
+Study ID	Theoretical or conceptual research	Declaration of research objective(s)	Clear description of the setting and target population	The study design is appropriate to address the research objective(s)	Appropriate sampling to address the research objective(s)	Rationale for the choice of data collection instrument(s)	The format and content of the data collection tool is appropriate to address the stated research objective(s)	Description of the data collection procedure	Recruitment data provided	Motivation of the analytical method selected	The method of analysis was appropriate to meet the research objective(s)	Evidence that they were taken into account in the design or conduct of the research	Strengths and limitations critically discussed	Score	
+Cole et al. (2012)	0	3	3	3	1	3	3	0	0	0	3	0	3	22	
+Graham et al. (2008)	0	2	3	0	0	0	3	0	0	0	3	0	3	14	
+Joseph et al. (2021)	1	2	3	3	1	0	3	0	0	0	3	0	0	16	
+Khan et al. (2017).	0	1	3	3	0	0	3	0	0	0	3	0	3	16	
+Løvlien et al. (2006)	0	3	3	3	1	0	3	3	3	0	3	0	3	25	
+Løvlien et al. (2009)	1	3	3	3	2	2	3	3	3	0	3	0	3	29	
+McSweeney et al. (2003)	0	3	1	0	0	2	3	3	3	0	3	0	3	21	
+McSweeney et al. (2010)	0	3	3	3	3	0	3	3	3	0	3	0	3	27	
+O'Keefe‐McCarthy et al. (2016)	0	3	3	3	3	0	3	3	3	1	3	0	3	28	
+Shi et al. (2020)	0	2	3	3	3	0	3	1	0	0	3	0	2	20	
+Soltani et al. (2021)	0	3	2	3	1	0	3	3	0	0	3	0	0	18	
+
+The three authors (V.G., C.M., A.G.) independently assessed the methodological quality using the Cochrane Risk of Bias in Non‐Randomized Studies of Interventions (ROBINS‐I) tool (Sterne et al. 2016), which assesses the methodological quality of non‐randomized studies across seven bias domains (Table 2). This tool categorizes the risk of bias into four levels: ‘Critical’, ‘Serious’, ‘Moderate’ and ‘Low’, where a ‘Low’ risk corresponding to the risk of bias in a high‐quality randomized trial.
+
+TABLE 2 Risk of bias domains (ROBINS‐I) (Sterne et al. 2016).
+
+tabular image
+
+4 Results
+
+4.1 Study Selection
+
+Our search strategy yielded a total of 2.170 studies in the initial stage, distributed as follows: 107 from PubMed, 90 from EMBASE, 447 from Cumulative Index to Nursing and Allied Health Literature (CINAHL) Complete, and 1.496 from APA PsycArticles, APA PsycInfo. 51 duplicate studies were excluded, leaving 2.119 for evaluation based on titles and abstracts. Of these, 2.061 were deemed irrelevant to the research objectives or inconsistent with the inclusion criteria. Full‐text access was obtained for all 58 remaining studies, which were then downloaded and thoroughly reviewed. Subsequently, 51 studies were excluded, while 8 articles met the criteria and were included in the review. Additionally, a supplementary free search was conducted, leading to the discovery of three articles. All full texts from this free search were downloaded. The systematic search yielded 11 studies published between 2003 and 2020. Figure 1 illustrates the PRISMA diagram (Page et al. 2021).
+
+4.2 Study Characteristics
+
+This systematic review included eight cross‐sectional studies (Cole et al. 2012; Løvlien et al. 2006, 2009; Khan et al. 2017; Shi et al. 2020; Soltani et al. 2021; Joseph et al. 2021; O'Keefe‐McCarthy et al. 2016), one retrospective study (McSweeney et al. 2010) and two descriptive studies (McSweeney et al. 2003; Graham et al. 2008). Nine studies have been conducted in developed countries, including Canada (Graham et al. 2008; O'Keefe‐McCarthy et al. 2016), China (Shi et al. 2020), Norway (Løvlien et al. 2006 and 2009), the United States (McSweeney et al. 2003, 2010; Cole et al. 2012) and one study was conducted across Canada, Switzerland and the United States (Khan et al. 2017). Two studies were instead conducted in two developing countries, Iran (Soltani et al. 2021) and India (Joseph et al. 2021).
+
+The review includes a total of 5.543 women over of 18 years of age with ACS, who were studied for prodromal symptoms. Seven studies (McSweeney et al. 2003, 2010; Graham et al. 2008; Løvlien et al. 2009; O'Keefe‐McCarthy et al. 2016; Khan et al. 2017; Joseph et al. 2021) examined prodromal symptoms in both women and men but were included in the review as it was possible to extract data specifically for women, and the authors were precise and clear in analyzing the warning symptoms in both sexes.
+
+There is considerable heterogeneity in the tools used to assess prodromal symptoms: most studies (Løvlien et al. 2006; McSweeney et al. 2003, 2013; Cole et al. 2012; Khan et al. 2017; Shi et al. 2020; Soltani et al. 2021) used the McSweeney Acute and Prodromal Myocardial Infarction Symptom Survey (MAPMISS) which includes descriptors for each symptom; women rate prodromal symptoms according to intensity (e.g., mild, severe) frequency (e.g., daily, weekly), and duration (e.g., 1 week or more than 1 month). MAPMISS also includes questions on comorbidity, risk factors, medications and demographic data (McSweeney et al. 2013); two studies (Løvlien et al. 2009; Joseph et al. 2021) used a specially designed self‐administered questionnaire; one study (O'Keefe‐McCarthy et al. 2016) used the Prodromal Symptoms‐Screening Scale (PS‐SS) which identifies nine cardiac‐related prodromal symptoms (unusually localized aches and/or pains, unusual fatigue, sleep disturbances, chest pain, anxiety, headache, dizziness and dyspnea) and finally one study (Graham et al. 2008) used the Ambulatory Care Classification System (ACCS) database, which contains up to 6 diagnostic queries, 10 procedure codes and the 5 potential groups of prodromal symptoms (pain, anxiety/fatigue, gastrointestinal disorders, head‐related disorders and others) (Graham et al. 2008).
+
+Key characteristics of the studies were aggregated and synthesized by developing summary tables (Table 3). This approach provided an organized and clear synthesis of the main findings from the studies examined. The use of such graphical representations has thus facilitated the understanding and visualization of key information and provived an effective overview of the data generated by the literature review.
+
+TABLE 3 Summarises the characteristics of included studies.
+
+Author(s) & year	Title	Study objective	Instrument	Geographic region/nation	Study design	Results	
+Cole et al. (2012)	Sleep Disturbance in Women Prior to Myocardial Infarction	Describe the prevalence and correlations of sleep disturbances among women who retrospectively reported sleep disturbances before myocardial infarction (MI)	MAPMISS	United States	Cross‐sectional study
+
+N = 1270 women
+
+	Odds ratio (95% CI) Anxiety 2.21 (1.71, 2.84)
+
+Unusual fatigue 2.16 (1.62, 2.89)
+
+Change in thinking and memory 1.47 (1.12, 1.94)
+
+Headache 1.54 (1.03, 2.29)
+
+Gastrointestinal symptoms 1.29 (1.00, 1.67)
+
+	
+Graham et al. (2008)	Sex Differences in Patients Seeking Medical Attention for Prodromal Symptoms Before an Acute Coronary Event	Determine if there are sex differences in seeking medical attention for prodromal symptoms in patients who subsequently present to the emergency room with acute coronary syndrome (ACS)	Database ACS	Canada	Descriptive study
+
+N = 2268 (1234 women)
+
+	Anxiety and fatigue (52.4%)
+
+Headache (15.8%)
+
+Gastrointestinal symptoms (3.4%)
+
+Other symptoms (13.3%)
+
+	
+Khan et al. (2017)	Sex Differences in Prodromal Symptoms in Acute Coronary Syndrome in Patients Aged 55 Years or Younger	Evaluate sex differences in prodromal symptoms including chest pain and non‐painful symptoms and health‐seeking behaviour in women and men aged 55 years or younger who had an ACS;
+
+Evaluate sex differences in pre‐hospital management of prodromal symptoms
+
+	MAPMISS	Canada, Switzerland and the United States	Prospective cross‐sectional study
+
+N = 1.145 patients (368 women)
+
+	Unusual fatigue (60%)
+
+Sleep disturbances (52.8%)
+
+Anxiety (44.4%)
+
+Palpitations (32.2%)
+
+Gastrointestinal symptoms (indigestion) (30%)
+
+Headache (24%)
+
+Cough (21.8%)
+
+Change in thinking and memory (21.8%)
+
+Dyspnea (20.8%)
+
+Loss of appetite (19.8%)
+
+Vision problems (14.7%)
+
+Difficulty breathing at night (13.5%)
+
+	
+Løvlien et al. (2006)	Are There Gender Differences Related to Symptoms of Acute Myocardial Infarction? A Norwegian Perspective	Compare the presentation of symptoms and disease behaviour among women and men with AMI in Nordic countries and evaluate various aspects that influence pre‐hospital delay	Self‐administered questionnaire	Norway	Cross‐sectional study
+
+N = 82 patients (38 woman)
+
+	Fatigue (52%)
+
+Dyspnea (26%)
+
+Chest pain (34%)
+
+	
+Løvlien et al. (2009)	Early Warning Signs of an Acute Myocardial Infarction and Their Influence on Symptoms During the Acute Phase With Comparisons by Gender	Investigate what types of prodromal symptoms occurred before AMI and how individuals responded to their prodromal symptoms with gender comparisons	Self‐administered questionnaire	Norway	Cross‐sectional study
+
+N= 533 patients (149 women)
+
+	Dyspnea (38%)
+
+Anxiety (35%)
+
+Nervousness (48%)
+
+Chest pain (44%)
+
+Fatigue (68%)
+
+	
+McSweeney et al. (2003)	Women's Early Warning Symptoms of Acute Myocardial Infarction	The most common prodromal symptoms of AMI
+
+how prodromal and acute symptoms relate to comorbidities and risk factors for coronary heart disease
+
+Whether prodromal symptoms were predictive of AMI symptomatology
+
+	MAPMISS	United States	Descriptive study
+
+N= 515 women
+
+	Unusual fatigue (70.7%)
+
+Sleep disturbances (47.8%)
+
+Dyspnea (42.1%)
+
+Gastrointestinal symptoms (indigestion) (39.4%)
+
+Anxiety (35.5%)
+
+Change in thinking and memory (23.9%)
+
+	
+McSweeney et al. (2010)	Racial Differences in Women's Prodromal and Acute Symptoms of Myocardial Infarction	Describe the prodromal and acute symptoms of AMI reported by women and determine if Hispanic and white women differ in symptoms
+
+Determine if the prodromal and acute symptoms reported by Hispanic and white women differ in severity and frequency when adjustments are made for known cardiovascular risk factors
+
+	MAPMISS	United States	Retrospective study
+
+N = 1270 women
+
+	Unusual fatigue (73%)
+
+Sleep disturbances (50.2%)
+
+Anxiety (45%)
+
+Dyspnea (45%)
+
+Gastrointestinal symptoms (frequent indigestion) (39%)
+
+	
+Joseph et al. (2021)	Atypical Manifestations of Women Presenting with Myocardial Infarction at Tertiary Health Care Center: An Analytical Study	Identify gender‐based differences in risk factors and clinical manifestations in patients presenting with AMI	Ad hoc questionnaire	India	Analytical cross‐sectional study
+
+N= 240 partecipants (120 women)
+
+	Dizziness, sweating, shortness of breath, vomiting, palpitations, fainting, back pain and fatigue (85%)	
+O'Keefe‐McCarthy et al. (2016)	Prodromal Symptoms Associated with Acute Coronary Syndrome Acute Symptom Presentation	Describe the prevalence, frequency and severity of prodromal symptoms in a sample of patients with ACS	PS‐SS scale—Pain Intensity—Speilberger State‐Trait Anxiety Personality Inventory	Canada	Descriptive cross‐sectional study
+
+N=121 participants (58 women)
+
+	Unusual pains (41.9%)
+
+Unusual fatigue (54.8%)
+
+Sleep disturbances (37.1%)
+
+Anxiety (61.3%)
+
+Dyspnoea (61.3%)
+
+Chest pain (67.7%)
+
+Headache (22.6%)
+
+Dizziness (35.5%)
+
+Others (54.8%)
+
+	
+Shi et al. (2020)	Sex Differences in Prodromal Symptoms and Individual Responses to Acute Coronary Syndrome	Examine potential sex differences in prodromal symptoms in Chinese patients with ACS and their individual responses to symptoms.	MAPMISS	China	Cross‐sectional study
+
+N= 806 patients (483 women)
+
+	Unusual fatigue (33.1%)
+
+Sleep disturbances (32.9%)
+
+Anxiety 26.2%
+
+Palpitations (20%)
+
+Dyspnea (30%)
+
+Gastrointestinal symptoms (indigestion) (46%)
+
+	
+Soltani et al. (2021)	The Association between Risk Factors and Prodromal Myocardial Infarction Symptoms: A Cross‐Sectional Study in Iran	Describe the prevalence and frequency of PS and risk factors in a sample of patients with AMI	MAPMISS	Iran	Cross‐sectional study
+
+N=154 patients (38 women)
+
+	Sleep disturbances and unusual fatigue (60%)
+
+Gastrointestinal symptoms (15.8%)
+
+Neurological symptoms (15.8%)
+
+	
+Note: ACS, acute coronary syndrome; AMI, acute myocardial infarction; MAPMISS, McSweeney Acute and Prodromal Myocardial Infarction Symptom Survey; MI, myocardial infarction; PS, prodromal symptoms; PS‐SS, Prodromal Symptoms‐Screening Scale.
+
+4.3 Quality of the Studies
+
+Quality assessment of the included studies was conducted using the QuADS tool (Harrison et al. 2021), as presented in Table 1. The studies included scored between 14 and 29 out of a maximum of 39 points. One of the studies scored less than 15 points. Ten studies achieved scores ranging from 16 to 29, and no study scored above 30. Studies assessed as ‘Serious’ using the ROBINS‐I tool (Sterne et al. 2016) (Table 2) were included with caution, while no study was deemed to have a ‘Critical’ risk. Among the 11 studies included, only three were rated as having ‘Moderate’ risk (Graham et al. 2008; Shi et al. 2020; Soltani et al. 2021) and eight as ‘Serious’ risk (McSweeney et al. 2003; Løvlien et al. 2006; Cole et al. 2012; O'Keefe‐McCarthy et al. 2016; Joseph et al. 2021). The main concerns leading to these ratings were in the domain of outcome measurement, due to the subjective nature of the measures (perceptions and self‐assessment), and participant selection due to the observational and retrospective design of most studies. Specifically, five studies exhibited a severe risk in the domain of ‘bias due to confoundin’ (McSweeney et al. 2003, 2010; Løvlien et al. 2009; O'Keefe‐McCarthy et al. 2016; Khan et al. 2017), six studies had a moderate risk (Graham et al. 2008; Cole et al. 2012; O'Keefe‐McCarthy et al. 2016; Khan et al. 2017; Shi et al. 2020; Soltani et al. 2021) and five studies showed a severe risk in the domain of ‘bias due to selection of participants’ (McSweeney et al. 2003, 2010; Løvlien et al. 2006 and 2009; Joseph et al. 2021). Only one study (Cole et al. 2012) demonstrated severe risk in the domain of ‘bias in classification of interventions’, unlike the moderate risk in the same domain reported in the studies by Khan et al. (2017) Feil (1937), O'Keefe‐McCarthy et al. (2016) and Joseph et al. (2021). The study by Joseph et al. (2021) alone showed severe risk in the domain of ‘bias due to deviations from intended interventions’; conversely, a moderate risk of ‘bias due to missing data’ was present in four studies (Løvlien et al. 2006; Graham et al. 2008; Khan et al. 2017; Shi et al. 2020). In the domain of ‘bias in measurement of outcomes', three studies (McSweeney et al. 2010; Cole et al. 2012; Joseph et al. 2021) presented severe risk and six studies (McSweeney et al. 2003; Løvlien et al. 2006 and 2009; Graham et al. 2008; Khan et al. 2017; Shi et al. 2020) a moderate risk; finally, only three studies (Cole et al. 2012; O'Keefe‐McCarthy et al. 2016; Khan et al. 2017) exhibited a moderate risk in the domain of ‘bias in selection of the reported result’.
+
+4.4 Prodromal Symptoms
+
+According to several studies, women report a notable prevalence and variety of prodromal symptoms of heart disease prior to acute events. Soltani et al. (2021) observed that 24% of women exhibit at least 2 prodromal symptoms, while 26% report at least 3, 10.5% at least 4 and 7.9% at least 5 symptoms. Khan et al. (2017) reported an average of 4.8 prodromal symptoms in women. Additionally, McSweeney et al. (2003) highlighted an average of 5.7 prodromal symptoms detected in women. Another study by McSweeney et al. (2010) on women from different ethnic groups revealed an average of 6 symptoms reported: 7.48 symptoms in black women, 6.98 in Hispanic women and 5.48 in white women (p < 0.01). 85% of women report prodromal symptoms, as reported by Khan et al. (2017), highlighting the significant prevalence of these symptoms in the female population (p < 0.0001). The literature shows that women report an average of six prodromal symptoms (Khan et al. 2017).
+
+The period of presentation of prodromal symptoms, as reported in the various studies, varies widely and, in some cases, is not specified. For example, the study by Løvlien et al. (2009), which used a self‐administered questionnaire, considers symptoms that occurred in the year prior to AMI. In contrast, the study by Shi et al. (2020), which used the MAPMISS, looks at symptoms in the 6 months prior to the event. Other studies, such as those by Soltani et al. (2021) and Graham et al. (2008), while using the same tool (MAPMISS), observe a time frame of 3 months. In contrast, in some studies, such as those by McSweeney et al. (2003, 2010), Cole et al. (2012) and Khan et al. (2017), which also use MAPMISS, the period of symptom onset is not given. The studies by Løvlien et al. (2006) and Joseph et al. (2021), which are based on self‐administered questionnaires, also do not specify the onset of symptoms, as does the study by O'Keefe‐McCarthy et al. (2016), which used the PS‐SS instrument.
+
+4.4.1 Chest Pain and Other Types of Pain (Upper and Lower Limb Pain, Jaw/Teeth/Throat and Generalized Unusual Pain)
+
+Khan et al. (2017) reports a percentage of 23.6% of chest pain, indicating it as a relevant symptom. Joseph et al. (2021) add further details, highlighting its location in the upper and interscapular chest part that radiates to the left arm (24.3%) of women, suggesting possible cardiac or musculoskeletal involvement. This data is also reported in the studies by Løvlien et al. (2006) and Løvlien et al. (2009) which highlight how this symptom is present respectively in 34% and 44% of cases, indicating its frequency and its importance in clinical evaluation. In both studies by McSweeney et al. (2003, 2010) an incidence of chest pain of 29.7% and 36%, pain, also defined with the term ‘discomfort’. If the women in the study by O'Keefe‐McCarthy et al. (2016) present this symptom for 67.7%, instead all the women enrolled in the study by Soltani et al. (2021) report chest pain or discomfort, underlining the wide range of conditions that can manifest with this symptom. In addition to chest pain, 66% of women report pain localized to the shoulder, 37% and 57% of back pain (Løvlien et al. 2006 and 2009). Data analysis shows that leg pain was studied in the article by Cole et al. (2012), which reported a significant association with an odds ratio of 2.10 (95% confidence interval: 1.29, 3.43). Arm pain is a symptom reported by women in 10 studies within the review: in the study by Cole et al. (2012) the odds ratio is 1.56 (95% CI: 1.14, 2.12) for pain in both arms. This data is confirmed in the studies by Løvlien et al. (2006) and from the study by Soltani et al. (2021) where the pain in both arms is reported from 23.7% to 61% of women. In this case, in addition to the term pain, women used terms like ‘discomfort, weak arms, heavy arms’ (Khan et al. 2017; McSweeney et al. 2003; Soltani et al. 2021) for 33.2%, 24.9% and, 1%, respectively. Other studies, however, report the presence of 45% of pain in one arm only (Løvlien et al. 2009), particularly the left arm (Joseph et al. 2021). Some studies also report the onset of pain in the jaw/teeth/throat in 6% (Khan et al. 2017) and 40% (Løvlien et al. 2006). Unusual, generalized pain is reported by O'Keefe‐McCarthy et al. (2016) in 41.9% and by Graham et al. (2008) in 54.5%.
+
+4.4.2 Fatigue
+
+Fatigue is a symptom present in eleven studies included in the review. From the data provided, we can observe that fatigue is reported with prevalence rates ranging from a minimum of 33.1% to a maximum of 85%. Specifically, Løvlien et al. (2006 and 2009) highlighted a high prevalence of fatigue, with percentages of 52% and 68%, respectively. McSweeney et al. (2003, 2010) reported even higher significant values, with percentages reaching 70.7% and 73%. Similarly, both Khan et al. (2017) and Soltani et al. (2021) detected a 60% rate of subjects reporting fatigue as a prodromal symptom. Other authors, such as Cole et al. (2012), Graham et al. (2008), O'Keefe‐McCarthy et al. (2016) and Shi et al. (2020) also report unusual fatigue of 2.16 (odds ratio, with a 95% confidence interval ranging from 1.62 to 2.89), 52.4%, 54.8% and 33.1%, respectively. Notably, an observation by Joseph et al. (2021) recorded a high prevalence of 85% of subjects reporting fatigue as a prodromal symptom. This particularly high figure underscores the importance of fatigue as an early signal of various diseases.
+
+4.4.3 Anxiety
+
+In the eight studies included in the review, anxiety emerges as a significant and common symptom. For instance, the study conducted by Cole et al. (2012) highlighted an odds ratio for anxiety of 2.21, with a 95% confidence interval ranging from 1.71 to 2.84. Graham et al. (2008) reported that anxiety, along with fatigue, was identified in 52.4% of cases, indicating that anxiety might be a relevant component of prodromal symptoms. Khan et al. (2017) reported a percentage of 44.4% of patients who reported anxiety, further confirming its significance. Løvlien et al. (2009) and McSweeney et al. (2003, 2010) reported a prevalence of 35% and 45%, while O'Keefe‐McCarthy et al. (2016) reported a higher percentage of 61.3%. Shi et al. (2020) report a lower level of anxiety (26.2%) compared to that reported in other studies. Overall, we can see that anxiety is a common symptom reported in many of the studies included, with prevalence percentages varying between 26.2% and 61.3%.
+
+4.4.4 Sleep Disorders
+
+Khan et al. (2017) reported that more than half of the participants, specifically 52.8%, reported sleep disturbances as a prodromal symptom. McSweeney et al. (2003, 2010) also highlighted a significant presence of sleep disorders, with percentages of 47.8% and 50.2% respectively, among the women involved in their studies. O'Keefe‐McCarthy et al. (2016) confirmed the importance of this symptom, finding that 37.1% of subjects experienced sleep disturbances during the prodromal period. Shi et al. (2020) reported a percentage of 32.9% of participants who reported sleep disturbances as a prodromal symptom. Finally, Soltani et al. (2021) noted that 60% of subjects reported sleep disturbances along with fatigue as prodromal symptoms. These data indicate that sleep disturbances are a relevant and widespread symptom in the early stages of some pathological conditions, with a frequency varying between 32.9% and 52.8%.
+
+4.4.5 Dyspnea and Respiratory Problems
+
+The studies analyzed highlighted the significant presence of dyspnoea as a prodromal symptom of AMI, with a frequency ranging from 20.8% to 61.3%. Khan et al. (2017) report a prevalence percentage of dyspnea of 20.8%; Løvlien et al. (2006) at 26% and subsequently in a 2009 study (Løvlien et al. 2009) at 38%; Shi et al. (2020) at 30%; McSweeney et al. (2003) and McSweeney et al. (2010) reported frequencies of 42.1% and 45% among their participants, reaching up to 61.3% in the study by O'Keefe‐McCarthy et al. (2016). Joseph et al. (2021) also report the presence of this symptom in their study. Khan et al. (2017) further document the presence of other respiratory problems, such as a frequency of 21.8% for coughing and 13.5% for night time breathing difficulty.
+
+4.4.6 Changes in Thinking and Memory
+
+The studies by Cole et al. (2012), Khan et al. (2017) and McSweeney et al. (2003) discuss changes in memory and thinking during the prodromal period. According to Cole et al. (2012), the change in thinking and memory has an odds ratio of 1.47 (95% CI: 1.12–1.94), Khan et al. 2017 at 21.8%, while McSweeney et al., in 2003, report that the change in thinking and memory was observed in 23.9% of cases.
+
+4.4.7 Gastrointestinal Symptoms
+
+Cole et al. (2012) report an odds ratio of 1.29 (95% CI: 1.00–1.67) for gastrointestinal symptoms. Graham et al. (2008) indicate a frequency of 3.4% for such symptoms. Khan et al. (2013), Shi et al. (2020) and Soltani et al. (2021) respectively 30%, 46% and 15.8% including indigestion. Also, in studies of McSweeney et al. (2003, 2010) report frequencies for indigestion symptom of 39.4% and 39% are reported, values also confirmed by Joseph et al. (2021) that reporting vomiting as a symptom. Gastrointestinal symptoms, reported in the review studies, thus have a frequency ranging between 3.4% and 39%.
+
+4.4.8 Headache
+
+Headache is a relevant symptom that can be associated with and predict acute myocardial infarction, and its presence can vary between 15.8% and 24% in women with AMI. Specifically, in a study conducted by Cole et al. (2012), the headache presents an odds ratio of 1.54 (95% CI: 1.03–2.29). Graham et al. (2008) identified headache as prodromal symptoms present in 15.8% of women, associating it with anxiety and fatigue. Khan et al. (2017) reported that headache was observed in 24% of cases, data comparable to the study conducted by O'Keefe‐McCarthy et al. (2016); the percentage of patients with headaches among them is 22.6%.
+
+4.4.9 Other Prodromal Symptoms
+
+In addition to the symptoms discussed previously, there are other prodromal symptoms of acute myocardial infarction in women not to be underestimated. In the study by Løvlien et al. (2009), women were significantly more likely than men to report being nervous (48%) (p < 0.01), to present palpitations, investigated in the study by Khan et al. (2017) and Shi et al. (2020), respectively with percentages of 32.3% and 20%. Women also may report loss of appetite (19.8%), vision problems (14.7%) and dizziness, as reported in the study by Joseph et al. (2021) (85%) or with a percentage of 35.5% in the study by O'Keefe‐McCarthy et al. (2016).
+
+5 Discussion
+
+This systematic review provides a synthesis and quantitative analysis of the evidence available in the literature on prodromal symptoms in women before SCA. The results confirm that women experience a wide range of prodromal symptoms, with prevalence rates as high as 85% (McSweeney et al. 2003, 2010; Khan et al. 2017). The review points out that women are less likely to manifest chest pain traditionally associated with AMI (Chandrasekhar et al. 2018; Blakeman et al. 2020), presenting instead with more heterogeneous symptoms (McSweeney et al. 2003, 2010; Khan et al. 2017; Blakeman and Booker 2016). This has relevant diagnostic implications, as chest pain, while the most commonly known symptom, is not always a primary indicator in women. Indeed, chest pain associated with AMI is a particularly relevant in females, as women tend to have worse outcomes even with timely diagnosis and emergency treatment (DeVon et al. 2008). Although chest pain remains a significant symptom of AMI, it is not always the most common prodromal symptom in women, who may experience a wider range of early indicators (Albarran et al. 2007; DeVon et al. 2008; Milner et al. 2004).
+
+In fact, some studies included in this review indicate that many women do not frequently report prodromal chest pain, and although present it is described as a sensation of pressure, constriction or discomfort (Albarran et al. 2007; Asghari et al. 2022). This aspect suggests the urgency of revising traditional diagnostic paradigms and adapting clinical guidelines to better address the gender‐specific manifestations of AMI (Albarran et al. 2007). Despite these differences, the 2022 AHA/ACC guidelines (Ramirez et al. 2022) point out that men can also manifest similar symptoms, such as pressure sensations or prodromal chest discomfort, thus reducing the need for exclusively gender‐based assessment (Gimenez et al. 2014). Consequently, it is essential to overcome the idea that AMI is always exclusively associated with chest pain, regardless of gender, as symptoms can vary significantly. The differences in symptoms between men and women with SCA can be explained by the way chest pain is transmitted through activation of the sympathetic and parasympathetic nerves. The afferent fibres of the sympathetic nerves are more concentrated along the left anterior coronary artery, whereas the parasympathetic fibres predominate along the right coronary artery and circumflex branch. Consequently, the area affected during an acute myocardial infarction may influence the predominance of sympathetic or vagal nerve activation. In particular, parasympathetic nervous system activation tends to be more common in patients with a right‐sided dominated coronary system, a feature found more frequently in women. This mechanism could help explain gender differences in the symptomatic presentation of AMI (Khan et al. 2013; Arora and Bittner 2015; Safdar et al. 2014; Canto 2007). The three most common prodromal symptoms in women reported in the included studies are fatigue, anxiety and sleep disturbance. Fatigue, in particular, is described as unexplained and so intense that it prevents the performance of normal daily activities, such as making the bed (McSweeney et al. 2010; Albarran et al. 2007) and having a lack of energy to complete daily tasks (Bowles 2013; Bruno 2013). This symptom, reported to have a prevalence of up to 70% (Albarran et al. 2007; Lindgren et al. 2008; Berg et al. 2009), was identified as the most common in seven out of nine studies in the review by Blakeman and Booker (2016). However, fatigue is a complex phenomenon (Whitehead 2009), impacting not only physical health but also cognitive processes, referred to as ‘mental fog’ (Ream and Richardson 1997). The complexity of this phenomenon may be one of the main reasons for the large variation in symptom prevalence, ranging from 33.1% to 85% in the included studies, along with other factors. This variability can be explained by differences in the characteristics of the female population analyzed (e.g., age and comorbidities), variations in the methods used to assess symptoms (such as the use of self‐completed questionnaires versus clinical assessments), and the adoption of different criteria or definitions to identify symptoms. In addition, cultural, regional and health system factors may influence how symptoms are reported or recognized.
+
+Anxiety reported by many women in the weeks before the event represents a significant prodromal symptom (Miller et al. 2009; Smeijers et al. 2016). The scientific literature defines this condition as anticipatory anxiety, which is not only associated with an increased risk of AMI but also contributes to a worse prognosis and exacerbates the severity of myocardial ischemia in the female sex (Bekendam et al. 2021), due to the pathophysiological mechanisms it triggers (Celano et al. 2015). Specifically, anxiety reduces parasympathetic nervous system activity and increases heart rate, thus leading to increased oxygen consumption by the heart. This can promote the onset of myocardial ischemia, even in the absence of severe coronary artery disease (Chalmers et al. 2014; Hofmann et al. 2014).
+
+Sleep disturbances have also been associated with an increased risk of cardiovascular disease in women, a risk that increases in women who sleep < 6 h per night (Chandola et al. 2010). Specifically, according to the study by Meisinger et al. (2007), women who sleep 5 h a night, compared to women who sleep 8 h, have a higher incidence of AMI; as well as reduced sleep duration is associated with elevated levels of inflammatory markers such as interleukin‐6 and C‐reactive protein, which contribute to cardiovascular risk (Miller et al. 2009).
+
+In addition to the three most frequently reported prodromal symptoms, women also report other less frequent signs, including gastrointestinal complaints, headache, cognitive changes, breathing difficulties, nervousness, palpitations, loss of appetite and pain. Although the incidence of these symptoms varies among studies, they are often overlooked or attributed to unrelated causes by the patients themselves (Lichtman et al. 2015; Soltani et al. 2021). Nevertheless, their presence should be carefully evaluated as a possible indicator of an impending cardiac event.
+
+The number and severity of prodromal symptoms is another aspect that comes from this review. Indeed, it was found that women report on average about six symptoms before an acute event, a finding that significantly affects their pre‐event health status. Specifically, women tend to have at least two of the three ‘most common’ prodromal symptoms, such as fatigue and sleep disturbance, with similar but severe intensity; as for the other ‘less common’ symptoms, such as shortness of breath and indigestion, these are classified as severe, moderate or mild with the same frequency (McSweeney et al. 2003, 2010).
+
+The period of presentation of prodromal symptoms reported in the various studies shows considerable methodological heterogeneity, reflecting the breadth and complexity of research in this field. Studies such as that of Løvlien et al. (2009), which consider the period of 1 year, provide a broad perspective useful for identifying prodromal symptoms that may vary over time; similarly, the approach of Shi et al. (2020), which focuses on the preceding 6 months, and that of Soltani et al. (2021) and Graham et al. (2008), which further reduce the period to 3 months, may provide greater temporal precision. The absence of a defined time window in some studies, such as those by McSweeney et al. (2003, 2010), Cole et al. (2012) and Khan et al. (2017), limits the ability to compare results across research and complicates the synthesis of generalisable conclusions. The same is true for studies using self‐completed questionnaires, such as those in Løvlien et al. (2006) and Joseph et al. (2021), or alternative instruments such as the PS‐SS in O'Keefe‐McCarthy et al. (2016), which do not provide a clear temporal definition.
+
+Early recognition of symptoms is crucial to reducing the risk of adverse cardiac events. However, for example, despite fatigue being an important symptom of AMI in women (Blakeman and Stapleton 2018; Blakeman et al. 2020), only 10% of women recognize fatigue as such (Mosca et al. 2013). This highlights the need for more targeted education for patients, as well as upgrading the skills of healthcare providers, particularly nurses, who are uniquely positioned to identify prodromal symptoms and promote a timely response (Giordano et al. 2024; Siebens et al. 2007). Studies such as that of Birnbach et al. (2020) show that advanced nursing education can improve the ability to recognize premonitory symptoms, increasing clinical response and reducing delays in treatment.
+
+In summary, this systematic review highlights the critical need for increased awareness of prodromal symptoms of ACS in women. By integrating these findings into clinical practice, health care providers can improve the accuracy and timeliness of diagnosis, ultimately reducing morbidity and mortality. Future research should aim to standardize methodologies for symptom assessment and explore targeted interventions to improve early recognition and management of cardiovascular risk in women. Addressing these gaps will be critical to achieving equitable and effective care for this population.
+
+This review has some limitations. First, the retrospective nature and reliance on convenience sampling in many of the included studies may introduce allocation bias. Such methodologies compromise the generalisability of the results and may bias outcomes toward specific patient demographic groups. Another limitation is the inclusion criterion restricted to women with confirmed diagnoses of ACS. This excludes a significant portion of the female population who may experience similar prodromal symptoms without a subsequent diagnosis, limiting understanding of the prevalence of these symptoms among the undiagnosed. Women may not remember their symptoms accurately or may unintentionally bias their responses, which may affect the reliability of the data. In addition, reliance on self‐reported rather than standardized instruments or the use of assessment criteria by health professionals could lead to underestimation of some symptoms.
+
+These instruments generally include a predefined list of symptoms, limiting participants to report only those symptoms included or to provide detailed descriptions outside of those given in the questionnaires. A significant limitation of the studies included in this systematic review concerns the considerable variability and, in some cases, lack of specification of the period of presentation of prodromal symptoms. Some studies consider large time intervals, such as a full year before the acute ischemic event, while others limit observation to 6 or 3 months, potentially neglecting longer periods of symptomatology. This is particularly relevant considering that qualitative studies in the literature indicate that prodromal symptoms in women can last an average of 4 to 6 months (Rosenfeld et al. 2005; Coventry et al. 2017; Arslanian‐Engoren and Scott 2017). Moreover, in some cases, the period of onset is not specified at all in the review, leaving an important gap in understanding the chronology of symptoms. This methodological heterogeneity not only makes it difficult to directly compare the results of the various studies but also complicates the identification of consistent patterns in prodromal symptoms, thereby limiting opportunities to develop robust evidence‐based clinical guidelines.
+
+5.1 Limitations
+
+The review presented significant methodological heterogeneity among the included studies, with variability in study designs (cross‐sectional, retrospective and descriptive), measurement instruments (e.g., MAPMISS, self‐administered questionnaires, PS‐SS) and characteristics of the analyzed populations. This diversity made it impossible to conduct a meta‐analysis, limiting the synthesis of results to a narrative analysis and reducing the generalizability of conclusions. In addition, the predominant use of self‐reported data introduced potential recall bias and a possible underestimation or overestimation of some symptoms. Another limitation concerns the difficulty in distinguishing data on female‐specific premonitory symptoms of myocardial infarction in studies with a male comparison group.
+
+Despite these limitations, the review methodology—being a systematic review—is a major strength, ensuring a structured and rigorous approach to data collection and analysis. This review provides an exhaustive overview focused solely on the prodromal symptoms of acute myocardial infarction in women, addressing an important gap in the literature. Moreover, the inclusion of studies not previously considered in other reviews adds new evidence and perspectives to the existing knowledge base. This expansion of research scope enhances our understanding of the prodromal symptoms associated with acute myocardial infarction in women, offering a more comprehensive and updated synthesis of the available evidence. Ultimately, the results, although interesting, must be interpreted with relative caution in light of the limitations.
+
+5.2 Implications and Recommendations for Practice
+
+Recognizing prodromal symptoms can significantly aid in the early identification of women at risk for coronary heart disease, allowing for a tailored approach to managing cardiovascular risk factors and reducing delays in seeking treatment during an acute coronary event. However, long‐term prospective studies are essential to fully understand the clinical significance of prodromal symptoms, especially in women with cardiac diseases. Further research is needed to confirm whether prodromal symptoms can predict future adverse cardiac events, as suggested in the study protocol by Giordano et al. (2024), and if they are more predictive than common comorbidities, as the current literature on this relationship is either limited or has certain limitations. It is also crucial to examine the effectiveness of prodromal scores in predicting abnormal outcomes in cardiovascular diagnostic tests and to assess whether there are differences in symptom manifestations exist between women from different ethnic groups. Similarly, it is necessary to examine how men may experience different prodromal symptoms than women, not only in terms of the type of symptoms reported, but also in terms of their frequency and intensity. These aspects may suggest the need for individualized diagnostic and therapeutic approaches that are more targeted to the specificities of each gender and ethnic group.
+
+In addition, the development of a recognized nomenclature of prodromal symptoms could improve our understanding of the epidemiology of the prevalence and incidence of prodromal symptoms of myocardial infarction in women and determine how these symptoms may vary based on ethnicity and risk factor profiles. Additionally, experts in the symptomatology of myocardial infarction in women should collaborate to validate and select a uniform tool for predicting infarction symptoms of myocardial infarction, thereby enabling the use of a predictive scale in clinical practice.
+
+Educating women about prodromal symptoms and involving caregivers in their identification may facilitate a timely initiation of cardiac evalutation. Early recognition of prodromal symptoms can not only identify individuals at risk for developing coronary disease, but may also reduce morbidity and mortality associated with coronary disease in women.
+
+6 Conclusions
+
+This systematic review provides an understanding of the prodromal symptoms associated with ACS in women. The results show that women may experience more prodromal symptoms during the ACS, such as fatigue, anxiety and sleep disorders. Although these symptoms are common, they are often unrecognized or misattributed to non‐cardiac causes, leading to delays in diagnosis and treatment. However, it is important to note that there is still no definitive understanding of the differences in prodromal symptoms between men and women and that the complexity of these symptoms cannot be stated with certainty due to the nature of the included studies.
+
+Author Contributions
+
+Conceptualization: V.G. and A.G. Methodology: V.G., A.G., and R.N. Software: V.G., A.G., and R.N. Validation: V.G., A.G., and R.N. Formal analysis: V.G. and A.G. Investigation: V.G., A.G., and A.G. Resources: V.G., A.G., and T.R. Data curation: V.G., A.G., and C.M. Writing – original draft preparation: V.G., A.G., and C.M. Writing – review and editing: V.G., A.G., R.N., and T.R. Visualisation: V.G. and A.G. Supervision: V.G. and T.R. Project administration: V.G. and A.G. All authors have read and agreed to the published version of the manuscript.
+
+Ethics Statement
+
+The authors have nothing to report.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Supporting information
+
+Appendix S1.
+
+Acknowledgements
+
+The authors have nothing to report. Open access publishing facilitated by Universita degli Studi di Napoli Federico II, as part of the Wiley ‐ CRUI‐CARE agreement.
+
+Data Availability Statement
+
+The data that support the findings of this study are available from the corresponding author upon reasonable request.
+
+
+References
+
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diff --git a/corpus/healthcare/text/0e2ac9252126f875.txt b/corpus/healthcare/text/0e2ac9252126f875.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12633947
+PMID: 41264619
+DOI: 10.1371/journal.pone.0337011
+Article ID: PONE-D-25-31551
+Article version: 1
+Subjects: Study Protocol, Medicine and Health Sciences, Oncology, Cancers and Neoplasms, Gynecological Tumors, Cervical Cancer, Medicine and Health Sciences, Diagnostic Medicine, Cancer Detection and Diagnosis, Cancer Screening, Medicine and Health Sciences, Oncology, Cancer Detection and Diagnosis, Cancer Screening, Medicine and Health Sciences, Oncology, Cancer Treatment, Medicine and Health Sciences, Oncology, Cancer Prevention, People and Places, Geographical Locations, Africa, Ghana, Research and Analysis Methods, Research Assessment, Systematic Reviews, Research and Analysis Methods, Database and Informatics Methods, Database Searching, Research and Analysis Methods, Mathematical and Statistical Techniques, Statistical Methods, Metaanalysis, Physical Sciences, Mathematics, Statistics, Statistical Methods, Metaanalysis
+
+Protocol for a systematic review and meta-analysis of the impact of cervical cancer prevention initiatives in Ghana
+
+Impact of cervical cancer programmes in Ghana
+
+https://orcid.org/0000-0002-7476-4578 Donkoh Emmanuel Timmy Conceptualization Methodology Writing – original draft Writing – review & editing 1 *
+Abdul Iddrisu Wahab Conceptualization Methodology Writing – review & editing 2
+https://orcid.org/0009-0000-2037-9167 Ahiakpa Abraham Kwadzo Conceptualization Methodology Writing – original draft Writing – review & editing 3
+Williams Isaac Methodology Writing – original draft Writing – review & editing 1
+Akologo Rita Nyaaba Methodology Writing – original draft Writing – review & editing 1
+Danyo Stephen Methodology Writing – review & editing 3
+Kubio Chrysantus Conceptualization Methodology Writing – review & editing 4
+Effah Kofi Conceptualization Writing – review & editing 3
+Amuah Joseph Emmanuel Conceptualization Methodology Writing – review & editing 5
+1 Screen and Treat Research Group, Centre for Research in Applied Biology, School of Sciences, University of Energy and Natural Resources, Sunyani, Ghana
+2 Department of Mathematics and Statistics, Ghana Communication Technology University, Accra, Ghana
+3 Catholic Hospital, Battor, Battor via Sogakope, Volta Region, Ghana
+4 Volta Regional Health Directorate, Ghana Health Service, Ho, Volta Region, Ghana
+5 School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
+Habtu Aweke Yitagesu Editor
+Addis Ababa University, ETHIOPIA
+Competing Interests: The authors have declared that no competing interests exist.
+
+* E-mail: timmy.donkoh@uenr.edu.gh
+Electronic publication date: 2025 Nov 20
+Publication date: 2025
+Volume: 20
+Issue: 11
+Electronic Location ID: e0337011
+Received 2025 Jul 4; Accepted 2025 Nov 3
+Copyright: © 2025 Donkoh et al
+Copyright year: 2025
+Copyright holder: Donkoh et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 0
+Table count: 1
+Page count: 9
+Data Availability: N/A. This is a review protocol. By nature, no data has been generated in preparing the protocol for submission. After the actual review, deidentified research data will be made publicly available.
+
+Data Availability
+
+N/A. This is a review protocol. By nature, no data has been generated in preparing the protocol for submission. After the actual review, deidentified research data will be made publicly available.
+
+Ÿ==============================Ÿ
+Background
+
+Cervical cancer, though preventable, remains the second most diagnosed cancer and the primary cause of cancer-related deaths among females in Sub-Saharan Africa. The significance of coordinated screening programmes for reducing the burden of cervical cancer in Africa is not well documented. This systematic review will summarize published reports from key databases, grey literature and programme reports to assess the performance of cervical cancer prevention programmes in Ghana.
+
+Methods
+
+To be eligible for inclusion, interventions must target Ghanaian women with cervical cancer screening and prevention strategies using methods such as visual inspection with acetic acid (VIA), mobile colposcopy, HPV DNA testing, cytology (Pap smear), and treatment approaches such as cryotherapy, thermal ablation, loop electrosurgical excision procedure (LEEP). A comprehensive electronic search strategy will be used to identify studies published since database inception, and indexed in MEDLINE, EMBASE, CINAHL and Web of Science. The search strategy will include MeSH terms (and synonyms) relevant to cervical cancer, screening/treatment methods, geographic focus and implementing institution. We will include searches for grey literature, recognizing the value of programmatic and governmental reports that might not appear in traditional databases. Search results will be summarized in line with PRISMA guidelines. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach will be used to evaluate and document evidence certainty for all outcomes, internal validity of included reports, inconsistency, indirectness, imprecision, and publication bias. Where sufficient homogeneity exists among included studies in terms of interventions, study designs, populations, and outcome measures, we will perform a meta-analysis to calculate pooled effect estimates and their corresponding 95% confidence intervals.
+
+Significance
+
+This systematic review will assess the performance and impact of cervical cancer screening and prevention programmes conducted in Ghana to date and identify what contextual strategies have delivered the most impact as well as highlight what gaps remain in our understanding of how a nationwide screening programme can be properly construed for maximum impact.
+
+Introduction
+
+Cancer of the cervix uteri is the fourth most common cancer and the second leading cause of cancer-related deaths among females [1]. By comparison, it ranks as the topmost cause of cancer-related deaths in Sub-Saharan Africa [2,3]. In the year 2022, approximately 660,000 incident cases and 350,000 mortalities from cervical cancer were recorded globally [4]. The fraction of these estimates attributable to developed countries has shrunk drastically over the years and at least 94% of this disease burden is traceable to developing countries from Latin America, East Asia and sub-Saharan Africa [1].
+
+Despite a decreasing trend in global incidence and mortality over the past few years, cervical cancer continues to be a troubling outcome of persistent high-risk HPV transmission in Sub-Saharan Africa [5,6]. This is largely due to a lack of organized and sustainable national programmes in sharp contrast to countries where well-structured cervical cancer prevention programs, including education, vaccination, and screening with prompt treatment of pre-cancerous lesions exist [7–9].
+
+In Ghana, HPV screening is largely opportunistic with accompanying financial constraints [10–12]. Attempts to eradicate cervical cancer as a public health threat, have been hampered by the failure to improve early disease detection and cost-efficient treatment [12]. While screening is generally considered useful, the significance of ad hoc campaigns and screening initiatives is difficult to gauge. Some argue that without appropriate systems linking women who screen positive to care, the net effect of screening may be undesirable. Moreover, important ethical and economic sustainability questions arise in such a context.
+
+An emerging strategy for ensuring the sustainability of screen-and-treat programmes in fragile health systems is to embed these services into existing programmes that are robust, familiar to healthcare staff and are closely related enough to be offered as a comprehensive package [13,14]. However, there is limited evidence on effective implementation strategies for providing cervical cancer prevention and treatment services at scale as part of integrated health services. This leads to the loss of patients to follow-up. Further, the disconnect between sporadic screening campaigns and treatment services worsens the healthcare inequities confronting the most vulnerable who make a livelihood in peri-urban and rural communities as well as high-risk groups such as women living with HIV and female sex workers.
+
+From the year 2000–2003, the Ghana Health Service in partnership with the John Hopkins Program for International Education in Gynaecology and Obstetrics (JHPIEGO), initiated the first Cervical Cancer Prevention (CECAP) programme, under the Safety, Accessibility, Feasibility and Program Effort (SAFE) demonstration project, locally known as the Cervicare Programme [15]. The SAFE/Cervicare project aimed to provide a ‘single visit’ screening with Visual Inspection with Acetic acid (VIA), linked to cryotherapy for suspicious lesions [16]. Another key initiative to address gaps in cervical cancer prevention and training in Ghana came in the form of the establishment of a Cervical Cancer Prevention and Training Centre (CCPTC) in the year 2017 in Battor. The primary aim of the CCPTC was to build human resource capacity across Ghana and in other similar low-resource settings to enable provision of crucial cervical pre-cancer screening and treatment services [14]. Aside these, other reports on screening programmes for cervical cancer prevention in Ghana have been published [17]. Unfortunately, the collective impact of approaches used in these programmes has not been documented [18]. This systematic review, therefore, aims to assess the performance and impact of cervical cancer screening and treatment programmes conducted in Ghana among women from database inception to date to identify what contextual strategies have delivered the most impact and what gaps remain in our understanding of how a nationwide screening programme can be properly construed for maximum impact.
+
+Methods
+
+Protocol registration and design
+
+The review protocol has been captured in the PROSPERO database (CRD420251035338). Our systematic review of the available published literature and secondary data on the performance of cervical cancer prevention programmes in Ghana will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, and this review protocol conforms to the PRISMA-P checklist (see Supporting information file 1: S1 Table) [19]. Although future amendments to this protocol are not anticipated, they will be recorded on the PROSPERO database and detailed in the review report as required.
+
+Literature search strategy and key terms
+
+A structured search will be conducted in line with the Cochrane Handbook for Systematic Reviews of Interventions [20] for all reports on cervical cancer screening and prevention programmes in Ghana (Table 1). We will identify keywords and phrases that accurately represent the various dimensions of the review. Terms such as “cervical cancer,” “cervical cancer screening,” and “”Pap test” or “HPV test” will be selected to address the health condition and screening method, while “screen-and-treat” and “screen and treat” will be chosen to capture studies emphasizing this specific approach. To ensure geographical relevance, the term “Ghana” will be included in search, and key implementing organizations such as “JHPIEGO” and “Cervical Cancer Prevention and Training Centre” (CCPTC) will be added, as these entities are known to have implemented relevant programs in the region. The search will be limited to all reports published since database inception until July 2025. Boolean operators and grouping will be employed to refine the search and ensure precision. By combining keywords with “AND” and “OR” and using quotation marks for exact phrases, we will craft queries that capture studies from various perspectives and sources. The use of MeSH terms and multiple databases will allow us to explore multiple permutations of keywords and expand the reach of our search. Large databases such as PubMed, CINAHL and Google Scholar will be queried. Additionally, relevant programme websites will be consulted to uncover project reports, evaluations, and publications, providing additional insights into programme implementation and results that may not be fully documented in peer-reviewed journals. To ensure comprehensive coverage, we will perform searches for grey literature and policy reports that might not appear in traditional databases. Resources such as WHO reports, Ghana Health Service publications, and ProQuest Dissertations & Theses will be searched for sources of grey literature, offering insights into implementation processes and outcomes often found in non-academic reports. This structured approach will provide a detailed and comprehensive view of the literature on cervical cancer screening and prevention in Ghana.
+
+10.1371/journal.pone.0337011.t001 Table 1 Example search strategy (MEDLINE/PubMed).
+
+Search item	Search component	Search Terms	
+1	Health Condition	“cervical cancer” OR “cervical precancer” OR “pelvic screening”	
+2	Screening/treatment method	“Pap test” OR “VIA” OR “visual inspection” OR “HPV test” OR “cryotherapy” OR “thermal coagulation”	
+3	Approach	“Screen-and-treat” OR “screen and treat” OR “screen-and-treat approach” OR “single visit approach”	
+4	Geographic focus	“Ghana” OR “Africa” OR “SSA”	
+5	Implementing organization	“JHPIEGO” OR “Ghana Health Service” OR “GHS” OR “Cervical Cancer Prevention and Treatment Centre” OR “CCPTC”	
+VIA: visual inspection with acetic acid; SSA: sub-Saharan Africa; JHPIEGO: Johns Hopkins Programme for International Education in Gynaecology and Obstetrics.
+
+Inclusion and exclusion criteria
+
+Population.
+
+We will include studies focusing on Ghanaian women screened for cervical cancer or precancerous lesions. Special interest studies on defined populations will be included as long as the participants fall within the target criteria.
+
+Intervention.
+
+Included reports must involve the intervention of interest, which shall be cervical cancer screening and prevention campaigns or programmes (e.g., SAFE/Cervicare, CCPTC) using methods such as visual inspection with acetic acid (VIA), mobile colposcopy, HPV DNA testing, cytology (Pap smear), and treatment approaches (e.g., cryotherapy, thermal ablation, LEEP). Reports are not required to include both screening and treatment; however, cervical cancer programmes or interventions that do not involve screening or treatment protocols will not be eligible.
+
+Comparator.
+
+Comparisons will be made between different screening programmes and screening/treatment approaches (e.g., VIA vs. HPV DNA testing).
+
+Outcomes.
+
+Primary outcomes will include screening coverage, positivity rates (e.g., VIA positivity, hr-HPV prevalence), treatment outcomes, and rates of loss to follow-up. Secondary outcomes will include programme reach, effectiveness, adoption, implementation, and maintenance (assessed using the RE-AIM framework), health worker training outcomes, and barriers to screening/treatment.
+
+Types of studies.
+
+We will search for reports on cervical cancer prevention activities (typically related to screening using a standard approach with or without follow-up treatment) in Ghana for inclusion. Published articles reporting on cervical cancer screening and prevention in Ghana from database inception with screening outcomes such as positivity rates, risk factors, challenges, and barriers to treatment and follow-up will be deemed eligible for inclusion. Conference abstracts with details about study population, screening approach, sample size, patient sampling methods and cervical cancer screening and prevention outcomes will also be included for screening. This systematic review will include population-based studies conducted in Ghana or those providing well-defined, disaggregated data analyses of Ghanaian cohorts. Multi-center studies incorporating Ghanaian participants will be eligible for inclusion, provided they report sufficient statistical detail specific to the Ghanaian subgroup. Studies meeting these inclusion criteria will proceed to the initial screening phase, as outlined in the study selection flowchart. Studies failing to meet the inclusion criteria will be excluded, including case reports, narrative or systematic reviews, expert opinions, and studies exclusively reporting data on Ghanaian populations residing outside Ghana. Although review articles will not be included in the primary analysis, a manual search of their reference lists will be conducted to identify additional relevant studies.
+
+Study selection process
+
+Citations retrieved from the database searches will be imported into Mendeley Desktop (version 2.129.0) for reference management, where duplicate records from multiple sources will be identified and removed using automated and manual deduplication processes. Two independent reviewers will conduct an initial screening of titles and abstracts to exclude studies that are clearly irrelevant or do not meet the predefined eligibility criteria, as outlined in the search strategy. Full-text articles of potentially eligible studies will then be retrieved and independently assessed by two reviewers to confirm adherence to the inclusion criteria, using a pre-designed, standardized checklist to ensure consistency. Studies focusing solely on training programmes will be excluded unless they report data on cervical cancer screening/treatment participation, screening/treatment outcomes, or factors influencing screening/treatment uptake. Any discrepancies between reviewers during title/abstract or full-text screening will be resolved through discussion to reach consensus or, if necessary, adjudication by a third reviewer. Data from included studies will be extracted into a standardized Microsoft Excel template, capturing relevant study characteristics, outcomes, and other predefined variables. In accordance with PRISMA guidelines, the reasons for excluding studies at the full-text screening stage will be systematically documented and reported in a transparent manner, including in the PRISMA flow diagram [19].
+
+GRADE assessment of the certainty of evidence
+
+The certainty of evidence for each outcome in this systematic review will be assessed using the GRADE approach, which evaluates risk of bias, inconsistency, indirectness, imprecision, and publication bias [20]. Primary outcomes, such as screening coverage, visual inspection with acetic acid (VIA) positivity rate, high-risk human papillomavirus (hr-HPV) prevalence, treatment outcomes, and loss to follow-up rate, will be evaluated for all included studies and programme reports. Secondary outcomes will also be assessed, including programme performance (assessed using the RE-AIM framework for Reach, Effectiveness, Adoption, Implementation, Maintenance) and health worker training coverage. Grey literature, such as programme reports will be evaluated using the AACODS checklist, assessing Authority, Accuracy, Coverage, Objectivity, Date, and Significance [21,22]. Serious methodological limitations, such as non-representative sampling or unclear reporting, will lead to downgrading of evidence [20].
+
+As the majority of studies are expected to be cross-sectional studies, the Joanna Briggs Institute (JBI) Critical Appraisal Tool for Analytical Cross-Sectional Studies will be adopted [23] to evaluate risk of bias, focusing on inclusion criteria, exposure and outcome measurement, confounder handling, and statistical analysis. For studies comparing interventions (e.g., screening methods), the ROBINS-I risk tool will ascertain the risk of bias across seven domains: selection, confounding, intervention classification, missing data, deviations, outcome measurement, and selective reporting [23,24]. Two review authors will independently apply the JBI appraisal tool and ROBINS-I to assess the internal validity of included studies. The JBI tool, designed for cross-sectional studies, evaluates eight criteria: clear inclusion criteria, detailed study description, valid exposure measurement, standard outcome criteria, confounder identification, confounder handling, valid outcome measurement, and appropriate statistical analysis. Responses will be rated as Yes, No, Unclear, or Not Applicable, with narrative synthesis determining overall risk of bias. ROBINS-I, developed for non-randomized studies of interventions in systematic reviews [23,24], rates bias as Low, Moderate, Serious, or Critical per domain. Studies with multiple No/Unclear JBI responses or Serious/Critical ROBINS-I ratings will be considered high risk of bias, informing GRADE assessments.
+
+Inconsistency will be assessed by examining variability in outcome estimates across studies, with substantial heterogeneity (e.g., due to differences in screening methods or populations) prompting downgrading unless explained by planned subgroup analyses (e.g., by screening method, programme type, or geographical setting). Indirectness will be evaluated to ensure evidence aligns with the review’s population (Ghanaian women), interventions (e.g., VIA, HPV DNA testing, cryotherapy), and outcomes. Imprecision will be assessed based on sample sizes and the availability of confidence intervals, with small or variable samples leading to downgrading. Publication bias will be explored narratively, considering the potential for selective reporting in grey literature, and, where meta-analysis is feasible, using Egger’s test for continuous outcomes or Begg’s test for binary outcomes.
+
+Discrepancies between review authors regarding the risk of bias assessments for individual studies will be investigated through structured discussion until a consensus is found. If consensus cannot be achieved, a third independent review author will be invited to adjudicate and provide a final decision. Results will be presented in a GRADE Summary of Findings table, detailing the certainty of evidence for each outcome (High, Moderate, Low, Very Low), and reported following PRISMA guidelines to ensure transparency.
+
+Data extraction, management and ethics
+
+Ethical approval was not required for the present study. Data from included full-text articles will be systematically extracted using a standardized, pre-piloted data extraction form designed to capture all relevant study characteristics and outcomes. Bibliographic details, including manuscript title, author names, publication date, and Digital Object Identifier (DOI), will be recorded to ensure accurate citation and traceability. Key study characteristics, such as sample size, target population, data collection period, geographical location, study objectives, eligibility criteria, and methodological design elements, will also be extracted to contextualize the research. Additionally, specific data related to cervical precancer screening and treatment approaches will be collected, including screening modalities, treatment interventions, and associated outcomes (e.g., screening uptake, diagnostic accuracy, treatment efficacy, or adverse events). All extracted data will be entered into a structured format and stored securely on an institutional server with regular offline backups to ensure data integrity and compliance with data protection standards.
+
+Presentation of data and results
+
+An accounting of the search procedure and report screening approach will be presented in the updated PRISMA flow chart [19]. Data and information obtained from a review of available literature will be put together and represented with tables, maps and figures for ease of comparison. Aggregated data from selected studies will be summarized using descriptive statistics.
+
+Statistical analysis
+
+Given the anticipated diversity in study designs (cross-sectional studies, baseline surveys of prospective studies, and programme reports), screening methods (e.g., visual inspection with acetic acid [VIA], HPV DNA testing, mobile colposcopy, cytology), and outcome measures (e.g., screening coverage, VIA positivity rates, high-risk HPV [hr-HPV] prevalence, treatment outcomes, loss to follow-up rates), we expect limited scope for meta-analysis. However, where studies report comparable outcomes (e.g., hr-HPV prevalence or VIA positivity rates) using similar screening methods and populations, we will explore the feasibility of pooling results using meta-analytic techniques. For studies with sufficiently homogeneous data, we will use R studio software to conduct a random-effects meta-analysis, as this approach accounts for expected between-study variability in effect sizes. For binary outcomes (e.g., proportion of women treated, loss to follow-up rates), we will compute risk ratios (RRs) or odds ratios (ORs) with 95% CIs, depending on the data reported. Two-sided p-values will be calculated for each outcome to assess statistical significance. To account for potential clustering effects in studies conducted across multiple regions or screening centres, we will adjust standard deviations for the design effect if intra-class correlation coefficients (ICCs) are provided in the study reports. If ICCs are not reported, we will use external estimates from similar cervical cancer screening and prevention studies in low-resource settings. Heterogeneity between studies will be assessed using the chi-square test for heterogeneity and the I2 statistic. An I2 value greater than 50% will be considered indicative of substantial heterogeneity, prompting further investigation. To explore sources of heterogeneity, we will conduct sensitivity analyses based on study quality, as assessed by the ROBINS-I and JBI risk appraisal tools. Studies with high risk of bias will be compared to those with low to moderate risk to evaluate the robustness of findings. We will perform subgroup analyses to investigate heterogeneity in effect estimates according to study quality, screening method, programme type, geographical setting and population characteristics.
+
+For outcomes where meta-analysis is not feasible due to heterogeneity or insufficient data, we will conduct a descriptive synthesis. This will involve summarizing key findings in tables, figures, and narrative text, focusing on screening coverage, positivity rates, hr-HPV prevalence, treatment outcomes, and loss to follow-up rates. Programme performance will be evaluated using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance), with scores compared across programmes to identify contextual strategies with the greatest impact.
+
+To assess potential publication bias, we will use Egger’s weighted regression test for continuous outcomes (e.g., hr-HPV prevalence) and Begg’s rank correlation test for dichotomous outcomes (e.g., direct visual inspection outcomes), provided at least 10 studies report the same outcome. Funnel plots will be visually inspected for asymmetry if meta-analysis is performed. For grey literature such as programme reports, we will narratively assess the risk of selective reporting by using the AACODS checklist as indicated above.
+
+Study timeline and status
+
+This review started in March 2025 with protocol design, search strategy optimization, and registration in PROSPERO (CRD420251035338). We expect to complete it and report results in 9–12 months: see Supporting information file 2 (S2 Table) for detailed timeline. Record screening, including title/abstract and full-text screening, is expected to commence in August 2025 in line with peer-reviewer feedback on study protocol. Data extraction using a standardized form is expected to be completed by October 2025, based on the number of included studies and complexity of data. The final synthesis, meta-analysis, and reporting of results are expected by January 2026. Any timeline updates will be documented in the PROSPERO entry.
+
+Conclusion
+
+This review will systematically update our understanding of the impact and performance of cervical screening programmes in Ghana. The systematic approach will produce a comprehensive synthesis of evidence from available published reports and identify gaps that require urgent attention for cervical cancer elimination. Results will be presented in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to ensure transparency and reproducibility. Finally, we will specifically explore programmatic strategies and approaches used and highlight which approaches are likely to yield the most impact in similar settings.
+
+Supporting information
+
+S1 Table PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 checklist: recommended items to address in a systematic review protocol.
+
+(DOCX)
+
+S2 Table Timeline and status of systematic review (CRD420251035338).
+
+(DOCX)
+
+Abbreviations
+
+CCPTC Cervical Cancer Prevention and Training Centre
+
+CECAP Climate and Ecological Crisis Action Plan
+
+CINAHL Cumulated Index in Nursing and Allied Health Literature
+
+DNA Deoxyribonucleic acid
+
+EVA Enhanced visual assessment
+
+GHS Ghana Health Service
+
+HPV Human papilloma virus
+
+hr-HPV High risk human papilloma virus
+
+JHPIEGO Johns Hopkins Programme for International Education in Gynaecology and Obstetrics
+
+LEEP Loop electrosurgical excision procedure
+
+MeSH Medical subject headings
+
+NIH National Institutes of Health
+
+PLHIV People living with Human immunodeficiency virus
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+RE-AIM Reach, effectiveness, adoption, implementation, and maintenance
+
+SAFE Safety, Accessibility, Feasibility and Programme Effort
+
+SVA Single visit approach
+
+USAID United States Agency for International Development
+
+VIA Visual inspection with acetic acid
+
+WHO World Health Organization
+
+
+References
+
+1 Sung H , Ferlay J , Siegel RL , Laversanne M , Soerjomataram I , Jemal A , et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. doi: 10.3322/caac.21660 33538338
+2 Ferlay J , Colombet M , Soerjomataram I , Parkin DM , Piñeros M , Znaor A , et al. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021;:10.1002/ijc.33588. doi: 10.1002/ijc.33588 33818764
+3 Tuck CZ , Cooper R , Aryeetey R , Gray LA , Akparibo R . A critical review and analysis of the context, current burden, and application of policy to improve cancer equity in Ghana. Int J Equity Health. 2023;22(1):254. doi: 10.1186/s12939-023-02067-2 38066530 PMC10709985
+4 Sung H , Ferlay J , Siegel RL , Laversanne M , Soerjomataram I , Jemal A . Estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71.10.3322/caac.21660 33538338
+5 Zhang X , Zeng Q , Cai W , Ruan W . Trends of cervical cancer at global, regional, and national level: data from the Global Burden of Disease study 2019. BMC Public Health. 2021;21(1):894. doi: 10.1186/s12889-021-10907-5 33975583 PMC8114503
+6 Jedy-Agba E , Joko WY , Liu B , Buziba NG , Borok M , Korir A , et al. Trends in cervical cancer incidence in sub-Saharan Africa. Br J Cancer. 2020;123(1):148–54. doi: 10.1038/s41416-020-0831-9 32336751 PMC7341858
+7 Olson B , Gribble B , Dias J , Curryer C , Vo K , Kowal P , et al. Cervical cancer screening programs and guidelines in low- and middle-income countries. Int J Gynaecol Obstet. 2016;134(3):239–46. doi: 10.1016/j.ijgo.2016.03.011 27350227
+8 Burger EA , Smith MA , Killen J , Sy S , Simms KT , Canfell K , et al. Projected time to elimination of cervical cancer in the USA: a comparative modelling study. Lancet Public Health. 2020;5(4):e213–22. doi: 10.1016/S2468-2667(20)30006-2 32057315 PMC8715100
+9 Binka C , Nyarko SH , Awusabo-Asare K , Doku DT . Barriers to the Uptake of Cervical Cancer Screening and Treatment among Rural Women in Ghana. Biomed Res Int. 2019;2019:6320938. doi: 10.1155/2019/6320938 31781631 PMC6874950
+10 Donkoh ET , Agyemang-Yeboah F , Asmah RH , Wiredu EK . Prevalence of cervical cancer and pre-cancerous lesions among unscreened Women in Kumasi, Ghana. Medicine (Baltimore). 2019;98(13):e14600. doi: 10.1097/MD.0000000000014600 30921178 PMC6456016
+11 Effah K , Tekpor E , Wormenor CM , Atuguba BH , Gedzah I , Amuah JE , et al. A revolution in cervical cancer prevention in Ghana. Ecancermedicalscience. 2022;16:ed123. doi: 10.3332/ecancer.2022.ed123 36200006 PMC9470175
+12 Dunyo P , Effah K , Udofia EA . Factors associated with late presentation of cervical cancer cases at a district hospital: a retrospective study. BMC Public Health. 2018;18(1):1156. doi: 10.1186/s12889-018-6065-6 30285699 PMC6171232
+13 Effah K , Attivor EK , Atuguba BH , Adaletey DD , Ofori DA , Diame P , et al. Application of the hub and spokes model in improving access to cervical cancer screening in Ghana. Ghana Med J. 2022;56(3):134–40. doi: 10.4314/gmj.v56i3.2 37448999 PMC10336637
+14 Effah K , Tekpor E , Wormenor CM , Essel NOM , Kemawor S , Sesenu E , et al. Tritesting in Battor, Ghana: an integrated cervical precancer screening strategy to mitigate the challenges of multiple screening visits and loss to follow-up. Ecancermedicalscience. 2023;17:1645. doi: 10.3332/ecancer.2023.1645 38414966 PMC10898900
+15 Blumenthal PD , Gaffikin L , Deganus S , Lewis R , Emerson M , Adadevoh S , et al. Cervical cancer prevention: safety, acceptability, and feasibility of a single-visit approach in Accra, Ghana. Am J Obstet Gynecol. 2007;196(4):407.e1-8; discussion 407.e8-9. doi: 10.1016/j.ajog.2006.12.031 17403438
+16 Kleine A. Outcomes Research Study on Cervical Cancer Prevention and Treatment: Results from Ghana Outcomes Research Study on Cervical Cancer Prevention and Treatment: Results from Ghana. 2008.
+17 AMPATH Ghana. AMPATH Ghana Works to Expand Cervical Cancer Screening and Treatment in Northern Ghana. In: Blog [Internet]. 31 Mar 2025 [cited 31 Mar 2025]. Available from: https://www.ampathghana.org/news-blog-feed/ampath-ghana-works-to-expand-cervical-cancer-screening-and-treatment-in-northern-ghana#:~:text=Our%20multidisciplinary%20working%20group%20developed,on%20communication%20skills%20and%20strategies
+18 Awua AK , Doe ED . Protocol for a systematic review of research on HPV and cervical cancer in Ghana, up until the year 2017: informing research and policy direction on cervical cancer prevention in Ghana. BMJ Open. 2018;8(7):e020183. doi: 10.1136/bmjopen-2017-020183 30002005 PMC6089304
+19 Page MJ , McKenzie JE , Bossuyt PM , Boutron I , Hoffmann TC , Mulrow CD , et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi: 10.1136/bmj.n71 33782057 PMC8005924
+20 Schünemann H , Higgins J , Vist G , Glasziou P , Akl EA , Skoetz N , et al. Chapter 14: Completing ‘Summary of findings’ tables and grading the certainty of the evidence [last updated August 2023]. In: Higgins J , Thomas J , Chandler J , Cumpston M , Li T , Page M , et al., editors. Cochrane Handbook for Systematic Reviews of Interventions. 2024. Available from: www.training.cochrane.org/handbook
+21 Galeotti M , Mitchell G , Tomlinson M , Aventin Á . Factors affecting the emotional wellbeing of women and men who experience miscarriage in hospital settings: a scoping review. BMC Pregnancy Childbirth. 2022;22(1):270. doi: 10.1186/s12884-022-04585-3 35361132 PMC8974061
+22 Tyndall J . AACODS Checklist. Chinese J Evid Based Med. 2010;7.
+23 Glasgow MJ , Edlin R , Harding JE . Comparison of risk-of-bias assessment approaches for selection of studies reporting prevalence for economic analyses. BMJ Open. 2020;10(9):e037324. doi: 10.1136/bmjopen-2020-037324 32938593 PMC7497530
+24 Sterne J , Hernán M , McAleenan A , Reeves B , Higgins J. Chapter 25: Assessing risk of bias in a non-randomized study [last updated October 2019]. In: Higgins JPT , Thomas J , Chandler J , Cumpston M , Li T , Page MJ , et al., editors. Cochrane Handbook for Systematic Reviews of Interventions version 65. Cochrane. Available: www.training.cochrane.org/handbook
diff --git a/corpus/healthcare/text/0ec44ac8201f2584.txt b/corpus/healthcare/text/0ec44ac8201f2584.txt
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+++ b/corpus/healthcare/text/0ec44ac8201f2584.txt
@@ -0,0 +1,52 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Food Sci Nutr
+Journal ID: Food Sci Nutr
+NLM Journal ID: 101605473
+Journal ID: FSN3
+
+Food Science & Nutrition
+
+EISSN: 2048-7177
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13181800
+PMID: 42157954
+DOI: 10.1002/fsn3.71876
+Article ID: FSN371876
+Article ID: 71876
+Article version: 1
+Subjects: Correction, Correction
+
+Correction to “In Vitro and In Planta Botanical Control of Banana Postharvest Disease Causing Fungi”
+
+Electronic publication date: 2026 May 18
+Publication date: 2026 May
+Volume: 14
+Issue: 5
+Electronic Location ID: e71876
+Copyright: © 2026 The Author(s). Food Science & Nutrition published by Wiley Periodicals LLC.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: In Vitro and In Planta Botanical Control of Banana Postharvest Disease Causing Fungi 14 3 8 3 2026 e71557 Food Science & Nutrition 10.1002/fsn3.71557 PMC12967518 41804345
+Figure count: 0
+Table count: 0
+Page count: 1
+
+source-schema-version-number: 2.0
+cover-date: May 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.8.4 mode:remove_FC converted:30.07.2026
+
+Ÿ==============================Ÿ
+Hossain, A., F. Akter, P. Ghosh, S. M. Naimul Islam, M. A. B. Bhuiyan, and S. S. Siddique. 2026. “In Vitro and In Planta Botanical Control of Banana Postharvest Disease Causing Fungi.” Food Science & Nutrition 14, no. 3: e71557. https://doi.org/10.1002/fsn3.71557.
+
+All authors' contribution are added to the article. The author contribution section should read as below:
+
+Afsana Hossain: analysis, visualization, review. Farjana Akter: data curation, investigation. Pallab Ghosh: data curation. Shah Mohammad Naimul Islam: formal analysis, software. Md. Abdullahil Baki Bhuiyan: fund acquisition, validation, review. Shaikh Sharmin Siddique: conceptualization, methodology, formal analysis, validation, writing – original draft.
+
+We apologize for this error.
+
diff --git a/corpus/healthcare/text/0f21a01751fca8bd.txt b/corpus/healthcare/text/0f21a01751fca8bd.txt
new file mode 100644
index 0000000000000000000000000000000000000000..869ab9690bfa3902583d5d0167c283dd5942adb9
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+++ b/corpus/healthcare/text/0f21a01751fca8bd.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Cardiovasc Med
+Journal ID: Front Cardiovasc Med
+NLM Journal ID: 101653388
+Journal ID: Front. Cardiovasc. Med.
+
+Frontiers in Cardiovascular Medicine
+
+EISSN: 2297-055X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13071514
+PMID: 41982214
+DOI: 10.3389/fcvm.2026.1806631
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Exercise training affects hemodynamics and exercise capacity in cases of heart failure with preserved ejection fraction: a non-randomized controlled trial in individuals aged 65–80 years
+
+Sugita Yousuke 1 * Investigation Conceptualization Funding acquisition Writing – original draft
+Ito Katsuhiko 2 Formal analysis Investigation Writing – review & editing
+Yoshioka Yui 3 Formal analysis Writing – review & editing Investigation
+Kudo Ayano 1 Formal analysis Writing – review & editing Investigation
+Arakawa Sota 1 Formal analysis Writing – review & editing Investigation
+Sakai Satoshi 1 Writing – review & editing Supervision Formal analysis Investigation
+1 Faculty of Health Sciences, Tsukuba University of Technology , Tsukuba , Japan
+2 Department of Rehabilitation, National Hospital Organization Matsumoto National Hospital , Matsumoto , Japan
+3 Department of Rehabilitation, Musashino General Hospital , Kawagoe , Japan
+* Correspondence: Yousuke Sugita y.sugita@cc.k.tsukuba-tech.ac.jp
+Electronic publication date: 2026 Mar 30
+Publication date: 2026
+Volume: 13
+Electronic Location ID: 1806631
+Received 2026 Feb 10; Revised 2026 Feb 23; Accepted 2026 Feb 26
+Copyright: © 2026 Sugita, Ito, Yoshioka, Kudo, Arakawa and Sakai.
+Copyright year: 2026
+Copyright holder: Sugita, Ito, Yoshioka, Kudo, Arakawa and Sakai
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Exercise training affects hemodynamics and exercise capacity in cases of heart failure with preserved ejection fraction: a non-randomized controlled trial in individuals aged 65–80 years 10 30 10 2023 1246739 Frontiers in Cardiovascular Medicine 10.3389/fcvm.2023.1246739 PMC10646767 38028475
+Keywords: echocardiography, exercise training, heart failure with preserved ejection fraction, peak arteriovenous oxygen difference, peak heart rate, peak oxygen uptake, peak stroke volume, ventilatory equivalent vs. carbon dioxide output slope
+
+Funding: Japan Society for the Promotion of Science 10.13039/501100001691
+Figure count: 0
+Table count: 2
+Equation count: 0
+Reference count: 0
+Page count: 4
+
+section-at-acceptance: General Cardiovascular Medicine
+
+Ÿ==============================Ÿ
+There was a mistake in figure 2, table 3 and table 4 as published. These errors were due to typographical and transcription errors in the presentation of the results. The corrected figure 2, table 3 and table 4 appear below.
+
+Figure 2 Changes in primary and secondary outcomes between both groups before and after exercise training intervention. peakVO2, peak oxygen uptake; E/e′, ratio of the mitral inflow early diastolic velocity to the mean e′ velocity from the septal and lateral sides of the mitral annulus; e′, peak early diastolic tissue velocity; LV-GLS, left ventricular global longitudinal strain; LAVI, left atrial volume index; BNP, brain natriuretic peptide; VE vs. VCO2 slope, ventilatory equivalent vs. carbon dioxide output slope.
+
+Six-panel figure comparing pre- and post-intervention changes between control and intervention groups for peakVO2, E/e', LV-GLS, LAVI, BNP, and VE/VCO2 slope. Data are presented as line graphs with group means and error bars. Significant time-by-group interactions are observed for most variables except E/e'. Tables below each graph summarize mean values, standard deviations, and within-group changes.
+
+In Figure 2, the incorrect follow-up values were corrected for peakVO2 in the control group, E/e′ in the intervention group, and LV-GLS in the control group. The graphical trends and statistical analyses were correct in the published article.
+
+Table 3 Changes in echocardiography data between both groups before and after cardiac rehabilitation intervention.
+
+	Control group
+(n = 50)	Intervention group
+(n = 49)	Change in 5 months, mean within-group difference (95% CI)	
+Parameters	Baseline	Follow-up	Baseline	Follow-up	Control group
+(n = 50)	Intervention group
+(n = 49)	
+Epicardial adipose tissue thickness (mm)	8.4 ± 0.9	9.0 ± 1.0	8.4 ± 0.6	7.5 ± 0.6*,†,‡	0.6 (0.5 to 0.7)	−0.8 (−0.8 to −0.9)	
+Interventricular septal thickness at end diastole (mm)	10.1 ± 1.0	10.2 ± 1.0	10.0 ± 0.9	10.0 ± 0.9*	0.11 (0.09 to 0.14)	0.02 (−0.02 to 0.07)	
+Posterior wall thickness at end diastole (mm)	10.2 ± 1.1	10.3 ± 1.1	10.0 ± 0.9	10.0 ± 0.9*	0.1 (0.1 to 0.2)	−0.002 (−0.029 to 0.033)	
+Left ventricular end-diastolic diameter (mm)	46.1 ± 1.9	46.0 ± 1.8	45.9 ± 3.0	45.8 ± 2.8	−0.1 (−0.2 to 0.1)	−0.13 (−0.29 to 0.03)	
+Left ventricular end-systolic diameter (mm)	29.6 ± 2.3	29.8 ± 2.4	28.9 ± 3.4	28.9 ± 3.4*	0.2 (0.1 to 0.3)	0.02 (−0.02 to 0.06)	
+Left ventricular end-diastolic volume index (mL/m2)	56.7 ± 6.1	56.2 ± 6.1	56.5 ± 9.5	56.4 ± 8.4	−0.5 (−1.4 to 0.3)	−0.1 (−1.3 to 1.2)	
+Left ventricular end-systolic volume index (mL/m2)	19.8 ± 3.8	20.0 ± 3.9	18.7 ± 5.0	18.9 ± 5.3	0.3 (−1.4 to 0.3)	0.2 (−0.2 to 0.7)	
+Left ventricular ejection fraction (%)	65.0 ± 6.0	64.3 ± 6.2	66.5 ± 8.2	66.3 ± 8.3	−0.7 (−1.2 to −0.3)	−0.2 (−0.6 to 0.1)	
+Left atrial ejection fraction (%)	47.5 ± 6.1	47.2 ± 6.5	45.7 ± 4.2	46.9 ± 6.2	−0.3 (−3.0 to 2.4)	1.3 (−0.5 to 3.0)	
+SI (mL/m2)	36.9 ± 5.5	36.1 ± 5.4	37.8 ± 8.8	37.5 ± 7.8	−0.8 (−1.4 to −0.1)	−0.3 (−1.2 to 0.6)	
+CI (L/min/m2)	2.5 ± 0.4	2.4 ± 0.4	2.7 ± 0.7	2.5 ± 0.5	−0.1 (−0.2 to −0.1)	−0.2 (−0.3 to −0.2)	
+Left ventricular mass index (g/m2)	117 ± 16	118 ± 18	115 ± 20	115 ± 20	1.1 (−0.8 to 3.0)	0.6 (−1.9 to 3.1)	
+Relative wall thickness	0.44 ± 0.05	0.45 ± 0.05	0.44 ± 0.04	0.44 ± 0.04*	0.006 (0.003 to 0.008)	0.001 (−0.001 to 0.003)	
+E (cm/sec)	59.7 ± 9.1	58.0 ± 9.4	60.9 ± 10.8	62.4 ± 10.6*,†,‡	−1.7 (−2.3 to −1.2)	1.4 (1.2 to 1.7)	
+A (cm/sec)	77.0 ± 13.1	74.9 ± 13.3	76.9 ± 7.1	77.5 ± 6.9*,†	−2.1 (−2.7 to −1.5)	0.6 (0.5 to 0.8)	
+E/A	0.8 ± 0.1	0.8 ± 0.1	0.8 ± 0.1	0.8 ± 0.1*,†	−0.001 (−0.008 to 0.006)	0.012 (0.011 to 0.015)	
+DcT (cm/sec)	236 ± 24.8	248 ± 24	241 ± 26	237 ± 25*,†,‡	11.6 (10.1 to 13.0)	−4.2 (−5.4 to −3.1)	
+Lateral e′ (cm/sec)	5.4 ± 1.1	5.1 ± 1.1	5.5 ± 2.0	5.6 ± 2*,†	−0.3 (−0.3 to −0.2)	0.1 (0.1 to 0.2)	
+Medial e′ (cm/sec)	2.9 ± 1.0	2.9 ± 1.1	3.6 ± 1.5	3.7 ± 1.5*,†,‡	−0.1 (−0.1 to 0.03)	0.1 (0.05 to 0.1)	
+Mean e′ (cm/sec)	4.2 ± 1.0	4.0 ± 1.1	4.5 ± 1.7	4.7 ± 1.7*,†,‡	−0.2 (−0.2 to −0.1)	0.1 (0.1 to 0.2)	
+E/e′ (cm/sec)	14.6 ± 1.4	14.7 ± 1.3	14.5 ± 3.3	14.4 ± 3.2	0.1 (−0.03 to 0.3)	−0.1 (−0.3 to 0.1)	
+Peak tricuspid regurgitation velocity (m/s)	2.8 ± 0.3	3.0 ± 0.3	2.8 ± 0.5	2.8 ± 0.5*,†,‡	0.1 (0.1 to 0.2)	−0.1 (−0.2 to −0.1)	
+Left atrial global longitudinal strain (%)	30.1 ± 3.5	26.9 ± 2.5	29.7 ± 4.0	35.0 ± 2.4*,†,‡	−3.1 (−4.0 to −2.2)	5.3 (4.2 to 6.4)	
+Mitral regurgitation volume (mL)	24.3 ± 10.0	25.1 ± 10.3	23.6 ± 9.1	22.7 ± 9*,†	0.4 (0.4 to 1.1)	−0.5 (−1.3 to −0.5)	
+Effective regurgitant orifice area (cm2)	0.2 ± 0.1	0.2 ± 0.1	0.2 ± 0.1	0.2 ± 0.1	−0.005 (−0.029 to 0.011)	−0.001 (−0.007 to 0.004)	
+Estimated pulmonary artery systolic pressure (mmHg)	43.3 ± 6.6	46.0 ± 6.8	42.8 ± 10.6	41.7 ± 9.9*,†,‡	2.7 (1.9 to 3.5)	−1.2 (−2.4 to 0.1)	
+Data are expressed as mean ± standard deviation.
+
+* p < 0.05 interaction, †p < 0.05 vs. before, ‡p < 0.05 vs. control groups.
+
+SI, stroke volume index; CI, cardiac output index; E, Peak early flow velocity; A, Late diastolic flow velocity; E/A, Ratio of peak early and late diastolic flow velocities; DcT, deceleration time; e′, Peak early diastolic tissue velocity; E/e', Ratio of the mitral inflow early diastolic velocity to the mean e′ velocity from the septal and lateral sides of the mitral annulus.
+
+In Table 3, the follow-up value for left ventricular end-diastolic volume index (LVEDVI) in the control group contained a transcription error and has been corrected.
+
+Table 4 Changes in cardiorespiratory exercise testing and hemodynamics data between both groups before and after cardiac rehabilitation intervention.
+
+	Control group
+(n = 50)	Intervention group
+(n = 49)	Change in 5 months, mean within-group difference (95% CI)	
+Parameters	Baseline	Follow-up	Baseline	Follow-up	Control group
+(n = 50)	Intervention group
+(n = 49)	
+Resting (Sitting posture)	
+ VO2 (mL/min/kg)	3.3 ± 0.6	3.6 ± 0.7	3.2 ± 0.5	3.7 ± 0.7*,†	0.2 (0.1 to 0.3)	0.5 (0.3 to 0.6)	
+ SI (mL/m2)	36.1 ± 3.6	36.5 ± 4.0	33.7 ± 4.8	36.7 ± 6.2*,†	0.4 (−0.3 to 1.1)	3.0 (1.9 to 4.2)	
+ HR (bpm/min)	72 ± 4	75 ± 6	74 ± 7	74 ± 7*	3.6 (2.3 to 4.9)	0.4 (0.3 to 1.2)	
+ CI (L/min/m2)	2.6 ± 0.3	2.8 ± 0.4	2.5± 0.4	2.7± 0.5	0.2 (0.1 to 0.2)	0.2 (0.1 to 0.3)	
+ a-vO2 diff (mL/100 mL)	5.1 ± 0.8	5.2 ± 0.8	5.1 ± 0.5	5.3 ± 0.5	0.1 (0.1 to 0.2)	0.1 (0.1 to 0.2)	
+ VO2/HR (mL/beat)	3.2 ± 0.6	3.3 ± 0.6	3.0± 0.5	3.3± 0.5*,†	0.1 (0.1 to 0.2)	0.3 (0.2 to 0.4)	
+Anaerobic threshold	
+ VO2 (mL/min/kg)	10.3 ± 2.7	9.6 ± 2.4	9.6 ± 2.0	11.0 ± 2.4*,†,‡	−0.7 (−0.9 to −0.4)	1.4 (1.2 to 1.6)	
+ Work rate (watt)	57 ± 15	56 ± 13	54 ± 11	65 ± 16*,†,‡	−1.8 (−2.8 to −0.7)	11 (9 to 13)	
+ SI (mL/m2)	44.1 ± 3.9	42.3 ± 2.9	42.5 ± 3.0	43.8 ± 3.1*,†,‡	−1.8 (−2.5 to −1.1)	1.3 (1.1 to 1.5)	
+ HR (bpm/min)	104 ± 11	99 ± 7	108 ± 8	111 ± 9*,†,‡	−5.2 (−7.3 to −3.2)	4 (2 to 5)	
+ CI (L/min/m2)	4.6 ± 0.5	4.2 ± 0.4	4.6 ± 0.5	4.9 ± 0.5*,†,‡	−0.4 (−0.5 to −0.3)	0.3 (0.2 to 0.4)	
+ a-vO2 diff (mL/100 mL)	8.7 ± 1.4	9.1 ± 1.5	8.3 ± 1.2	8.8 ± 1.4*,†	0.3 (0.2 to 0.5)	0.5 (0.4 to 0.6)	
+ VO2/HR (mL/beat)	6.7 ± 1.4	6.7 ± 1.4	6.2 ± 1.3	6.7 ± 1.5*,†	0.1 (−0.1 to 0.2)	0.5 (0.5 to 0.6)	
+Peak exercise	
+ Work rate (watt)	79 ± 24	70 ± 25	76 ± 21	83 ± 27*,†,‡	−9 (−11 to −7)	7 (5 to 10)	
+ SI (mL/m2)	44.2 ± 4.1	42.9 ± 4.2	42.6 ± 4.0	42.8 ± 3.9*	−1.2 (−1.5 to −1.0)	0.2 (−0.1 to 0.6)	
+ HR (bpm/min)	125 ± 14	120 ± 15	127 ± 13	131 ± 15*,†,‡	−5 (−6 to −4)	4 (3 to 6)	
+ CI (L/min/m2)	5.6 ± 1.0	5.2 ± 1.0	5.4 ± 0.9	5.6 ± 1.0*,†,‡	−0.4 (−0.4 to −0.3)	0.2 (0.1 to 0.3)	
+ a-vO2 diff (mL/100 mL)	10.0 ± 1.6	9.6 ± 1.8	10.0 ± 1.5	10.2 ± 1.6*,†,‡	−0.5 (−0.6 to −0.4)	0.3 (0.2 to 0.3)	
+ VO2/HR (mL/beat)	7.7 ± 1.5	7.2 ± 1.6	7.4 ± 1.7	7.6 ± 1.7*,†	−0.5 (−0.6 to −0.4)	0.2 (0.1 to 0.3)	
+Other indicators	
+ ΔVO2/ΔWork rate (mL/min/work rate)	8.0 ± 0.7	7.5 ± 0.6	8.0 ± 0.9	8.5 ± 0.6*,†,‡	−0.6 (−0.6 to −0.4)	0.5 (0.3 to 0.6)	
+ Minimum VE/VCO2 (mL/mL)	34.4 ± 2.5	36.2 ± 2.0	34.3 ± 2.4	30.9 ± 2.5*,†,‡	1.8 (1.3 to 2.3)	−3.4 (−3.8 to −2.9)	
+ Percent of peak HR (%)	86 ± 9	82 ± 10	87 ± 8	90 ± 10*,†,‡	−3.5 (−4.2 to −2.7)	3 (2 to 4)	
+ HRR (beat)	8 ± 3	7 ± 2	9 ± 3	11 ± 4*,†,‡	−1 (−2 to −1)	2 (1 to 3)	
+Data are expressed as mean ± standard deviation.
+
+* p < 0.05 interaction, †p < 0.05 vs. before, ‡p < 0.05 vs. control groups.
+
+RER, Respiratory exchange ratio; VO2, oxygen uptake; SI, Stroke volume index; HR, Heart rate; CI, Cardiac output index; a-vO2 diff, arterial-venous oxygen difference; VO2/HR, Oxygen pulse; ΔVO2/ΔWork rate, oxygen uptake-work rate relationship; Minimum VE/VCO2, minimum ventilatory equivalent for carbon dioxide; VE vs. VCO2 slope, ventilatory equivalent vs. carbon dioxide output slope.
+
+In Table 4, across the table, the values in the “Change (within-group difference)” column were incorrectly assigned between the control and intervention groups. The baseline and follow-up values were correct, and only the change values have been corrected.
+
+The original version of this article has been updated.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Edited and Reviewed by: Andrea Salzano, University of Leicester, United Kingdom
+
diff --git a/corpus/healthcare/text/1126ae218902aa21.txt b/corpus/healthcare/text/1126ae218902aa21.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Diabetes Res
+Journal ID: J Diabetes Res
+NLM Journal ID: 101605237
+Journal ID: JDR
+
+Journal of Diabetes Research
+
+ISSN: 2314-6745
+EISSN: 2314-6753
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13255150
+PMID: 42274148
+DOI: 10.1155/jdr/3322840
+Article ID: JDR3322840
+Article version: 1
+Subjects: Review Article, Article
+
+Measurement Properties of Instruments Used to Assess Diabetic Foot: An Umbrella Review
+
+Kim Nagyeong https://orcid.org/0009-0008-4783-5677 1
+Song Youngshin https://orcid.org/0000-0002-2203-5840 1 yssong87@cnu.ac.kr
+
+Dahal Padam padamdahal1@gmail.com
+
+1 College of Nursing , Chungnam National University , Daejeon , Republic of Korea , cnu.ac.kr
+Electronic publication date: 2026 Jun 11
+Publication date: 2026
+Volume: 2026
+Electronic Location ID: 3322840
+Revised 2026 May 12; Received 2025 Oct 26; Accepted 2026 May 18
+Copyright: Copyright © 2026 Nagyeong Kim and Youngshin Song. Journal of Diabetes Research published by John Wiley & Sons Ltd.
+Copyright year: 2026
+License: This is an open access article under the terms of the https://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: assessment instrument, COSMIN, diabetic foot, measurement properties, psychometrics, umbrella review
+
+Funding: National Research Foundation of Korea 10.13039/501100003725 RS-2026-25476867
+Figure count: 1
+Table count: 3
+Reference count: 46
+Page count: 19
+
+source-schema-version-number: 2.0
+cover-date: 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.8.0 mode:remove_FC converted:11.06.2026
+
+Kim, Nagyeong , Song, Youngshin , Measurement Properties of Instruments Used to Assess Diabetic Foot: An Umbrella Review, Journal of Diabetes Research, 2026, 3322840, 19 pages, 2026. 10.1155/jdr/3322840
+
+Academic Editor: Padam Dahal
+
+Ÿ==============================Ÿ
+Aims
+
+Diabetic foot is a severe, chronic complication that contributes substantially to morbidity and mortality. Numerous instruments have been developed to support systematic foot evaluation; however, their measurement properties have not been sufficiently evaluated. This umbrella review is aimed to synthesize evidence from systematic reviews on diabetic foot assessment tools, evaluate their methodological quality, and compare the psychometric properties and clinical applicability of the identified tools.
+
+Materials and Methods
+
+A systematic search of PubMed, EMBASE, the Cochrane Library, CINAHL, and Web of Science databases identified reviews published between 2010 and 2025. Two reviewers independently screened the studies, extracted data, and assessed methodological quality using the risk of bias in systematic reviews (ROBIS) and COnsensus‐based Standards for the selection of health Measurement INstruments (COSMIN) tools.
+
+Results
+
+Eleven systematic reviews encompassing 24 instruments were analyzed. The ROBIS appraisal rated most reviews (73%) as having a high risk of bias. The instruments were grouped into four categories with frequent overlaps: screening, risk stratification, wound classification, and infection/healing monitoring. Evidence of reliability and construct validity was common, whereas measurement errors, responsiveness, and cross‐cultural validation were rarely assessed. Heterogeneity and methodological weaknesses limit robust conclusions.
+
+Conclusions
+
+This umbrella review highlights the substantial gaps in the psychometric evaluation of assessment tools for diabetic foot, compounded by methodological flaws in supporting systematic reviews. Clinicians should exercise caution in tool selection, and future research should prioritize rigorous validation studies and high‐quality systematic reviews to establish standardized evidence‐based instruments.
+
+1. Introduction
+
+Diabetic foot is a serious chronic complication of diabetes, characterized by infection, ulceration, and/or destruction of deep tissues in the lower limbs, and is typically associated with peripheral neuropathy and varying degrees of peripheral arterial disease [1, 2]. This condition significantly contributes to morbidity and mortality among patients with diabetes, with diabetic foot ulcers (DFUs) being the most prevalent clinical manifestation [3]. The estimated global prevalence of DFUs is approximately 6.3%, posing substantial burdens on healthcare systems worldwide [4, 5].
+
+DFUs are associated with high risks of serious complications, including soft tissue and bone infections, prolonged hospitalization, and nontraumatic lower limb amputations [6]. Up to 85% of diabetes‐related lower‐extremity amputations are preceded by a foot ulcer that progresses to severe infection or gangrene [7]. Given the high prevalence and clinical impact of diabetic foot, a clear understanding of its complications is essential, because they profoundly influence patient outcomes, quality of life, and healthcare costs [2, 8].
+
+These complications predominantly arise from peripheral neuropathy and vascular insufficiency, which lead to tissue damage, delayed wound healing, and increased infection susceptibility [9, 10]. Neuropathic ulcerations are among the most common complications resulting from a loss of protective sensation caused by peripheral neuropathy [11]. Infections, including cellulitis, abscesses, and osteomyelitis, occur frequently because of impaired immunity and poor vascular supply [12, 13]. Charcot neuroarthropathy is a less common but serious complication, characterized by progressive joint dislocation and deformity due to autonomic neuropathy and repetitive trauma [14–16]. Lower extremity amputation may become unavoidable when tissue necrosis, severe infection, or nonhealing ulcers are present [17, 18]. Thus, if diabetic foot complications are not identified at an early stage, morbidity risk increases and individuals face substantial physical, social, psychological, and economic burdens, including higher mortality and loss of independence [19, 20].
+
+Clinical guidelines emphasize routine foot examinations as the cornerstone of comprehensive diabetes care [21]. To support routine foot assessments, various diabetic foot screening tools have been developed to evaluate clinical parameters, such as sensory function, vascular status, skin condition, and foot structure [19]. The commonly used tools include the Inlow′s 60‐second Diabetic Foot Screen, International Working Group on the Diabetic Foot (IWGDF) risk stratification categories, perfusion, extent, depth/tissue loss, infection, sensation (PEDIS) classification system, and the site, ischemia, neuropathy, bacterial infection, and depth (SINBAD) score. These instruments rely on visual inspection, simple sensory tests, and structured clinical criteria to stratify patient risks and guide preventive and therapeutic decision‐making.
+
+Previous studies and guidelines categorized diabetic foot assessment tools differently, reflecting diverse clinical purposes [19, 22]. For instance, some reviews grouped tools based on whether they assess neuropathy, ulceration risk, or wound healing, whereas guidelines, such as the IWGDF, distinguish between risk‐stratification systems, wound classification scores, and infection grading schemes [22]. Moreover, the characteristics and measurement properties of these tools were evaluated using various criteria. This heterogeneity highlights the lack of a unified framework for classifying diabetic foot measurement tools and judging their properties despite their widespread use in clinical practice and research.
+
+Reflecting this challenge, various systematic reviews have aimed at synthesizing the characteristics, measurement properties, and clinical utility of assessment tools for diabetic foot from diverse perspectives. For example, systematic reviews investigated tools for evaluating diabetic foot wounds as well as instruments for risk classification, clinical diagnosis, and symptom screening. However, the measurement properties of these tools, such as their reliability, validity, responsiveness, and clinical applicability, are often inconsistently reported across studies, raising concerns regarding their optimal use in both clinical and research contexts [19, 23]. An umbrella review—a systematic review of existing systematic reviews—offers a rigorous and comprehensive approach for synthesizing current evidence on the measurement properties of diabetic foot assessment instruments [24, 25]. Therefore, an umbrella review is warranted to consolidate the fragmented evidence base, critically appraise methodological rigor, and provide unified evidence‐based guidance for both clinical practice and future research.
+
+The present umbrella review is aimed at (a) synthesizing evidence from published systematic reviews on diabetic foot assessment tools, (b) evaluating the methodological quality and risk of bias of the included reviews, (c) classifying diabetic foot assessment tools according to their clinical purpose and compare their psychometric properties based on the COSMIN framework, and (d) identifying gaps in the current evidence base regarding the clinical applicability and psychometric evaluation of diabetic foot assessment tools.
+
+2. Materials and Methods
+
+2.1. Study Protocol and Registration
+
+This umbrella review was conducted and reported in accordance with the preferred reporting items for systematic reviews and meta‐analyses–COnsensus‐based Standards for the selection of health Measurement INstruments (PRISMA‐COSMIN) guideline for outcome measurement instruments (OMIs) [26], which integrates the PRISMA [27] reporting standards with the COSMIN methodology [28, 29]. This review evaluated the measurement properties of instruments used for diabetic foot assessment. The protocol for this umbrella review is registered in the International Prospective Register of Systematic Reviews (PROSPERO CRD420251073116).
+
+2.2. Search Strategy: Identification of Studies via Databases
+
+We searched electronic databases, including PubMed, EMBASE, Cochrane Library, CINAHL, and Web of Science, for studies published between 2010 and June 19, 2025. For this review, the following population, exposure, comparison, and outcome (PECO) question was used: “Which instruments (E) for assessing diabetic foot conditions in individuals with diabetes (P) demonstrate acceptable measurement properties (O) and are applicable in clinical practice?” Each database was searched using keywords and medical subject heading (MESH) terms related to the keywords. The keywords and MESH terms were combined with “OR” and “AND” Boolean operators. To improve the precision and comprehensiveness of systematic review retrieval, we applied validated search filters developed by the InterTASC Information Specialists′ Subgroup (ISSG) [30]. In addition, we manually screened the reference lists of all included studies to identify potentially eligible studies that were not identified in the electronic search.
+
+2.3. Inclusion and Exclusion Criteria
+
+We included systematic reviews and meta‐analyses that examined the measurement properties of instruments for assessing diabetic foot. Eligible studies enrolled patients with diabetes mellitus, including those with suspected or confirmed diabetic foot disease (DFD). We also included studies in patients with diabetes whose medical history presented with symptoms characteristic of DFD, including DFU, diabetic peripheral neuropathy (DPN), distal symmetric polyneuropathy (DSPN), and amputation. No restrictions were placed on participant ethnicity, sex, or age. Studies using any measurement tool to measure diabetic foot outcomes were considered (exposure). Regarding the outcomes, studies reporting measurement properties (e.g., reliability, validity, and responsiveness) of diabetic foot assessment instruments were considered.
+
+The exclusion criteria were as follows: studies not related to DFD (e.g., ulcer, amputation, neuropathy, ischemia, or infection); studies not involving diabetic foot‐related assessment tools (e.g., medical devices, predictive models, or instruments assessing quality of life or activities of daily living in patients with diabetic foot); studies with inappropriate methodologies, including primary studies (nonreviews), case studies, study protocols; and studies for which the full texts were unavailable.
+
+2.4. Study Screening and Selection
+
+The studies identified through the database searches were imported into reference management software (EndNote X9), and duplicate records were removed. The first author screened the titles and abstracts of the remaining studies to assess their relevance to the review topic. Potentially eligible studies were retained for full‐text review. Uncertainties or potential reasons for exclusion were documented separately during this phase. The corresponding author reviewed the study selection process and all included studies to ensure consistency and validity. Discrepancies at any stage were resolved through discussion between the first and corresponding author until consensus was reached.
+
+2.5. Data Extraction and Coding Scheme
+
+Two reviewers independently extracted the specified variables from each selected study. The following information was extracted from each review.
+
+2.5.1. Study Characteristics
+
+The study characteristics are as follows: author(s), publication year, type of review, number of included studies, DFD instruments, review objectives, clinical setting (e.g., community, primary care, and hospital), psychometric properties reported, methodology or guidelines used (e.g., PRISMA and COSMIN), and specific focus of the review.
+
+2.5.2. Instrument Characteristics
+
+Name of the tool, country of origin, number of tools identified in the included studies, target population (e.g., patients with DFU and diabetes), initial purpose (e.g., screening), number of items, scoring system, domains assessed, and user type (e.g., clinician‐administered and self‐reported). To ensure consistency and comparability of evidence across sources, only instruments reported in two or more reviews were retained for evaluation; those mentioned in a single review were excluded.
+
+2.5.3. Classification and Synthesis of Measurement Tool Properties
+
+The tools addressed in the systematic reviews included in the analysis were classified according to previous guidelines and systematic reviews [19, 22, 31] for the purpose of measuring diabetic feet, such as screening, risk stratification, wound classification, and infection or healing monitoring. Using the COSMIN framework, we extracted data on psychometric properties, including internal consistency, reliability, measurement error, content validity, structural validity, hypothesis testing for construct validity, cross‐cultural validity, criterion validity, responsiveness, and interpretability. For tools evaluated in multiple reviews, we also considered the consistency and quality of the reported evidence (e.g., sufficient, insufficient, or indeterminate) [20].
+
+2.6. Quality Appraisal of the Systematic Reviews
+
+We assessed the quality of the included reviews using the Cochrane risk of bias in systematic reviews (ROBIS) tool. The ROBIS assessment covers four domains (study eligibility criteria; study identification; data collection; and study appraisal, synthesis, and findings) with judgments of low, high, or unclear risk. An overall ROBIS judgment was also recorded [32]. The ROBIS assessment was performed in two stages: (a) domain‐level assessment and (b) overall judgment, combining domain‐level ratings to determine an overall risk of bias classification (low, high, or unclear). We summarized the results in structured tables. Disagreements between reviewers were resolved through discussion or, when necessary, consultation with a third reviewer.
+
+2.7. Classification and Properties of the Included Measurement Tools
+
+We classified the tools for diabetic foot assessment into four categories according to the main clinical objectives presented in the guidelines and previous review studies [19, 22, 23].1. Screening: Screening tools are aimed at identifying risk factors at an early stage, before ulceration develops, focusing on peripheral neuropathy, peripheral arterial disease, loss of protective sensation, and foot deformities. According to the IWGDF Practical Guidelines, regular screening provides a basis for preventive strategies and determines whether risk stratification is required.
+
+2. Risk stratification: Risk stratification tools were designed to categorize patients into groups according to their risks for ulceration or amputation. These tools consider patient‐ and limb‐related characteristics, such as neuropathy, vascular disease, or a history of ulcers, and provide clinicians with criteria for adjusting follow‐up intervals and the intensity of preventive care.
+
+3. Wound classification: Wound classification tools provide a structured assessment of existing DFUs by grading their severity and prognosis. Systems such as the Wagner classification, University of Texas classification, PEDIS, and SINBAD classify ulcers based on their depth, size, ischemia, infection, and tissue loss, thereby guiding treatment decisions and predicting clinical outcomes.
+
+4. Infection/healing monitoring: Infection and healing monitoring tools evaluate the presence, extent, and progression of infection and are used to track healing; for example, by determining whether the ulcer has achieved complete epithelialization, monitoring the treatment response, and identifying the risk of recurrence.
+
+The psychometric properties of each identified measurement tool were assessed according to the COSMIN taxonomy. Where applicable, we evaluated the following properties: content validity, structural validity, internal consistency, cross‐cultural validity, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness. Each property was rated as sufficient (+), insufficient (−), or indeterminate (?) depending on the quality and completeness of the supporting evidence. Interpretability was described separately because it is not classified as a psychometric property under the COSMIN framework. All evaluations were performed independently by two reviewers, and discrepancies were resolved through discussion or by a third reviewer when required. To ensure transparency and comparability across studies and instruments, the final ratings were summarized in structured tables.
+
+3. Results
+
+3.1. Literature Search
+
+A total of 802 studies were identified. After removing duplicates, completing the preliminary screening, and reviewing the full texts, the umbrella review ultimately included 11 studies. The study search and selection processes are presented in Figure 1.
+
+Figure 1 PRISMA flow diagram of the study screening and selection process. PRISMA, preferred reporting items for systematic reviews and meta‐analyses; DFD, diabetic foot disease.
+
+3.2. Study Characteristics and Tool Outcomes
+
+The main characteristics of the included studies are summarized in Table 1. Eleven systematic reviews published between 2010 and 2025 were included. Most (72.7%) were published within the last decade, reflecting growing interest in diabetic foot assessment. Among the included studies, three performed meta‐analyses (S3, S9, and S11) and eight (S1, S2, S4, S5, S6, S7, S8, and S10) comprised only systematic reviews. The number of studies included in the reviews varied between 6 (S5) and 149 (S10). These reviews examined 24 instruments for diabetic foot assessment used in diverse healthcare settings (Supplement 1). These tools ranged from simple screening instruments (e.g., United Kingdom Screening Test [UKST] and Basic Foot Screening Checklist [BFSC]) to comprehensive protocols for risk stratification (e.g., American Diabetes Association System [ADA] and IWGDF), wound classification (e.g., Wagner, PEDIS, and SINBAD), and infection or healing monitoring (e.g., Pressure Ulcer Scale for Healing [PUSH] and Bates–Jensen Wound Assessment Tool [BWAT]). Most studies were clinician‐administered and assessed domains such as neuropathy, peripheral arterial disease, ulcer depth and size, infection status, ischemia, and previous amputation. In addition, although some reviews used frameworks such as COSMIN to evaluate the measurement properties of the tool, reporting of validity, reliability, and responsiveness remained variable, underscoring the need for further standardization.
+
+Table 1 General characteristics of included systematic reviews (N = 11).
+
+Study	Author (year)	Review type	No. of included studies	Identified DFD instruments	Purpose of the review	Clinical setting (e.g., community, primary care, hospital)	Psychometric properties reported	Using method or guideline	Specific focus	
+1	Karthikesalingam et al. (2010)	SR	17	11 scoring systems +6 validation/comparative studies:
+
+Wagner, University of Texas (UT) system, DEPA, PEDIS, SINBAD, S(AD) SAD, NPUAP, and others.
+
+	To critically appraise the published literature of wound scoring systems for diabetic foot ulcers.	Mostly hospital and specialist diabetic foot clinics.	Validity and interrater reliability variably reported; limited data on responsiveness, measurement error.	The PRISMA guideline was followed for systematic review reporting. COSMIN was not used for comparison of validation studies.	Most diabetic foot ulcer scoring systems lack rigorous validation and exhibit limited reliability. Simplified tools such as SINBAD, DEPA, and DUSS show promise for clinical use, though external validation and interrater reliability data remain scarce. Among these, SINBAD is most commonly used, and simpler tools are generally recommended in clinical settings.	
+2	Monteiro‐Soares et al. (2011)	SR	13	5 risk classification systems: IWGDF risk classification system, Boyko′s tool, Leese system, and several ad hoc models.	To systematically identify and evaluate risk stratification systems for diabetic foot ulcer development.
+
+To assess the methodological quality and predictive validity of these systems.
+
+	Primary care and outpatient diabetes clinics.	Validity (predictive performance) evaluated in most tools; reliability and responsiveness not assessed.	STARD and STROBE guidelines were applied, with predictive metrics such as AUC, sensitivity, and specificity reported.	Risk stratification systems for diabetic foot ulcers are numerous, but generally show low methodological quality. Only a few systems, such as PODUS, Boyko, and IWGDF, have been externally validated and demonstrate acceptable predictive performance.	
+3	Monteiro‐Soares et al. (2014)	SR, MA	25	15 classification systems: Wagner, UT, DEPA, PEDIS, SINBAD, others.	To assess the ability of classification systems to predict lower extremity amputation (LEA) in patients with active DFUs.	Secondary/tertiary care (specialist foot clinics, hospitals).	Pooled predictive metrics (e.g., sensitivity, specificity); limited mention of reliability or responsiveness.	Partial use of STROBE/STARD and diagnostic metrics (AUC, sensitivity, specificity, LR) was reported.	The Wagner, S(AD)SAD, and University of Texas systems are the most frequently evaluated, yet overall evidence on their reliability and accuracy remains limited.	
+4	Ortega‐Avila et al. (2019)	SR	11	11 PROMs: DFS‐SF, FFI, FAAM, Q‐DFD, others.	To identify PROMs that are specific for DM affecting the foot and ankle and to evaluate their psychometric properties and methodological quality.	Community/outpatient	Internal consistency, construct validity assessed.	COSMIN and Terwee criteria were applied for quality and measurement assessment.	The Foot Health Status Questionnaire (FHSQ) demonstrates the highest psychometric quality among PROMs currently available for foot and ankle assessment in patients with diabetes.	
+5	Yoonhee and Youngshin (2019)	SR	6	6 DFU risk/assessment tools developed 2007–2016: foot assessment form, BFSC, SEWSS, UKST, a 60‐second tool, DFUAS.	To analyze the attributes and psychometric properties of newly developed diabetic foot complication assessment tools.	Primary care, community	Mentioned development/validation steps, limited detail.	No explicit guideline used; content analysis approach with some reporting of reliability and validity.	Only three tools reported reliability and validity, with most focusing on current status assessment rather than prediction. A variety of diabetic foot assessment tools were developed between 2007 and 2016 for diverse purposes; however, many lacked comprehensive psychometric validation. Further development and standardization—particularly for predictive and culturally adapted tools—are needed.	
+6	Fernández‐Torres et al. (2020)	SR	29	39 clinician assessment tools: PEDIS, SINBAD, DEPA, etc.	To carry out a systematic review of valid and reliable clinician assessment tools for measuring diabetic foot disease‐related variables and analyzing their psychometric properties.	Specialist clinical	Reliability, validity discussed; limited responsiveness.	COSMIN‐based evaluation included sensitivity, specificity, AUC, and interrater/intrarater reliability.	There is a general lack of comprehensive psychometric data for clinician‐administered assessment tools. However, several instruments demonstrate validity for specific purposes: UENS for diabetic neuropathy, QHRFF for ulceration risk, PEDIS and SINBAD for DFU assessment and amputation risk, and LUMT for ulcer measurement.	
+7	Pérez‐Panero et al. (2021)	SR	12	11 PROMs: DFSQ‐UMA, Q‐DFD, DFS‐SF, NeuroQol, etc.	To conduct a systematic review regarding the specific PROMs related to the evaluation of diabetic foot disease and to extract and analyze the values of their measurement properties.	Outpatient	Internal consistency, validity, responsiveness reported.	Measurement properties (validity, reliability, responsiveness) were assessed using the COSMIN checklist; PRISMA guidelines were followed.	Although most tools lack robust evidence, DFS‐SF and NeuroQoL show relatively strong properties. DFSQ‐UMA and Q‐DFD are recommended for comprehensive DFU assessment, though further validation is warranted.	
+8	Smet et al. (2021)	SR	27	14 chronic wound assessment tools (e.g., PUSH, BWAT)	(1) To systematically identify assessment tools for chronic wounds. (2) To examine their measurement properties and to summarize the data per assessment tool.	Hospital, nursing homes	COSMIN‐based appraisal; strong reliability and responsiveness.	Measurement properties were systematically assessed for each tool using the COSMIN Risk of Bias checklist, following PRISMA guidelines.	Most tools show limited psychometric quality. PUSH 3.0 and RESVECH 2.0 appear promising, though evidence is limited. Some validity and reliability findings are supported by moderate to high‐quality evidence.	
+9	Maldonado‐Valer et al. (2023)	SR, MA	36	IWGDF risk classification system	To determine the overall prevalence of diabetic foot at risk according to the International Working Group on the Diabetic Foot stratification.	Community, primary care	Prevalence‐focused review with limited psychometric detail; heterogeneity observed and subgroup analyses performed.	Subgroup prevalence and metaregression were performed; the review followed IWGDF, PRISMA, and was PROSPERO‐registered.	The global prevalence of foot at risk is 53.2%, with marked regional heterogeneity. The IWGDF classification is useful globally but requires careful contextual interpretation.	
+10	Monteiro‐Soares et al. (2024)	SR	149	28 Classification tools for DFU: UT, PEDIS, SINBAD	To assess published systems used to characterize ulcers in people with diabetes to determine which should be recommended to (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) characterize people with infection and/or peripheral arterial disease, and (d) audit to compare outcomes in different populations. This systematic review is part of the process of developing the 2023 guidelines to classify foot ulcers from the International Working Group on Diabetic Foot.	Specialist clinical	Validity, reliability, usability Updated assessment of previous systems	Validity, reliability, and clinical utility were assessed using PRISMA, IWGDF recommendations, and GRADE criteria.	Of 29 identified systems, six show potential for clinical use. Wagner, UT, and PEDIS were frequently reviewed, but most lack strong evidence. IWGDF offers context‐specific recommendations.	
+11	Welling et al. (2025)	SR/MA	96	13 Prognostic scores in PLAN framework: WIfI, GLASS, others	The 2019 Global Vascular Guidelines recommend risk assessment for evidence‐based revascularization based on the acronym PLAN: Patient risk, Limb severity and ANatomical complexity of disease. This meta‐analysis compares a multitude of prognostic tests within these categories.	Vascular surgery	AUC, sensitivity, specificity AUCs, calibration and validation presented	AUC, sensitivity, and specificity were assessed via Kaplan–Meier reconstruction and meta‐analysis. PRISMA, PROSPERO, GRADE, and MINORS were applied.	WIfI, GLASS, and GermanVasc are recommended under the PLAN concept for CLTI. Clinical use is advised only for tools with AUC ≥ 70%, though many lack sufficient reporting.	
+Abbreviations: AUC, area under the curve; COnsensus‐based Standards for the selection of health Measurement INstruments; DFD, diabetic foot disease; DFU, diabetic foot ulcer; IWGDF, International Working Group on the Diabetic Foot; MA, meta‐analysis; PROMs, patient‐reported outcome measures; PRISMA, preferred reporting items for systematic reviews and meta‐analyses; SR, systematic review; STARD, standards for reporting diagnostic accuracy studies; STROBE, strengthening the reporting of observational studies in epidemiology.
+
+3.3. Quality Assessment of Included Systematic Reviews
+
+We used the ROBIS system to assess the risk of bias at the systematic review level (Table 2). Overall, one review (9%) was judged to have a low risk of bias, two reviews (18%) had an unclear risk, and most (eight reviews; 73%) were classified as having a high risk of bias. At the domain level, the study eligibility criteria domain revealed high concerns in several reviews owing to the absence of prespecified protocols, insufficient justification for eligibility restrictions, and a lack of clarity regarding study selection procedures. In the identification and selection of studies domain, concerns were most often related to incomplete search strategies, exclusion of grey literature without justification, and inadequate documentation of the screening processes. For the data collection and study appraisal domains, high risk ratings were primarily attributed to the absence of duplicate data extraction, inconsistent use of validated risk of bias tools for primary studies, and insufficient reporting of data extraction procedures. In the synthesis and findings domain, the common limitations included a lack of sensitivity analyses, failure to explore publication bias, and limited integration of the primary study risk of bias assessments into the interpretation of the findings. The reviews rated as having unclear risk generally demonstrated stronger methodological safeguards, such as protocol registration, broader search coverage, and the use of established critical appraisal tools; however, they still lacked transparency in certain areas, particularly in reporting the operational definitions for eligibility criteria and conducting robustness checks of the synthesized results. The single low-risk of bias review adhered to best practices across all domains, including preregistration, comprehensive and unrestricted literature searches, duplicate screening, data extraction, application of validated appraisal tools, and explicit incorporation of risk‐of‐bias considerations.
+
+Table 2 Quality assessment of the included studies according to Risk of Bias Assessment Tool for Systematic Reviews.
+
+Study	Study eligibility criteria	Identification and selection of studies	Data collection and study appraisal	Synthesis and findings	Risk of bias in the review	
+1.Karthikesalingam et al. (2010)	High	High	High	High	High	
+2.Monteiro‐Soares et al. (2011)	High	High	High	High	High	
+3.Monteiro‐Soares et al. (2014)	High	High	High	High	High	
+4.Ortega‐Avila et al. (2019)	High	High	High	High	High	
+5.Yoonhee and Youngshin (2019)	High	High	High	High	High	
+6.Fernández‐Torres et al. (2020)	Unclear	Unclear	High	High	High	
+7.Pérez‐Panero et al. (2021)	Unclear	Unclear	High	High	High	
+8.Smet et al. (2021)	Unclear	Low	Low	Low	Unclear	
+9.Maldonado‐Valer et al. (2023)	Low	Low	Low	Low	Low	
+10.Monteiro‐Soares et al. (2024)	Unclear	Low	Unclear	Unclear	Unclear	
+11.Welling et al. (2025)	High	High	High	High	High	
+
+3.4. Psychometric Properties of Each Measurement Tool According to the Four Classifications
+
+Table 3 presents the classification and summary of the psychometric properties measured using COSMIN. From the 11 systematic reviews, 24 tools for assessing diabetic foot were extracted and classified into four categories (screening tools, risk stratification instruments, wound classification tools, and infection or healing monitoring tools).• Screening tools, including the UKST, BFSC, and Questionnaire for Diabetes‐Related Foot Disease (Q‐DFD), did not report measurement properties in most studies; therefore, most domains generally exhibited limited psychometric evidence, marked as “not reported,” “indeterminate,” or “insufficient.” The lack of psychometric evidence may be explained by their pragmatic design as brief screening instruments rather than rigorously validated measurement tools [19, 33]. These tools address key areas (e.g., peripheral neuropathy, vascular conditions, foot structure and deformation, and amputation history) and are used as primary screening tools for the early detection of high‐risk patients with diabetes [19, 33]. The advantages of these tools are that they can be easily applied in clinical settings without complex devices, and they are mainly used in primary care, outpatient clinics, and educational fields. However, rather than making a final diagnosis using the tool itself, high‐risk groups should be identified and undergo additional evaluations.
+
+• Risk stratification instruments, including the Saint Elian Wound Score System (SEWSS), Diabetic Ulcer Severity Score (DUSS), and IWGDF, showed higher sufficiency ratings in construct validity but did not evaluate other domains such as internal consistency or measurement error. All these tools stratify the clinical risk of patients with diabetes, classify patients into low‐ to high‐risk groups, and use them for follow‐up, management, and treatment decisions. However, overall evidence supporting their measurement properties was limited. This gap reflects the fact that these instruments were developed primarily as clinical decision aids rather than psychometrically validated tools, that existing studies are often small, and that evaluation criteria and outcomes are heterogeneous [21, 23]. Several tools also overlap with other domains: DUSS includes wound severity features, WIfI integrates wound, ischemia, and infection to inform their potential for healing, and the Size (Area and Depth), Sepsis, Arteriopathy, and Denervation (S(AD)SAD) system links these tools to risk stratification, including ulcer size, depth, sepsis, and neuropathy, as well as wound classification and healing monitoring [19, 22, 34].
+
+• Wound classification tools (e.g., SINBAD, PEDIS, and UT classification) showed some consistency in construct validity; however, structural validity and reliability data were often absent or inconsistent, as these tools were originally designed for clinical staging and communication rather than as rigorously validated measurement instruments [23]. Evidence for these systems remains limited because various tools (e.g., Wagner, PEDIS, and UT) have been developed and utilized for different purposes, such as prognosis prediction, treatment planning, and research standardization, making it difficult to accumulate consistent validation. Moreover, standardization studies are insufficient [23]. Furthermore, the heterogeneity of patients with diabetes, including vascular disease, neuropathy, and infection risk, as well as wide variations in wound location, size, and healing patterns, prevent the universal applicability of a single classification system [2, 23, 35, 36]. The inherent variability of wounds and subjectivity of clinical evaluation also restrict long‐term validation, thus relying on empirical expert judgment [37]. Despite these limitations, the tools mainly describe ulcer characteristics such as depth, infection, ischemia, and neuropathy, and are widely applied for clinical communication and treatment decisions [19, 23]. Several systems also integrate domains beyond classification: SINBAD incorporates ischemia, neuropathy, and infection, enabling its use in risk stratification; PEDIS includes infection and sensation, linking it to infection or healing monitoring; and the Curative Health Services (CHS) wound grade scale also captures wound status relevant for healing monitoring [19, 22, 38].
+
+• Infection or healing monitoring tools, such as PUSH and DFUAS, showed stronger psychometric evidence overall, particularly in responsiveness and criterion validity, yet many lacked validation of internal consistency or cross‐cultural applicability. The limited evidence for these tools reflects the inherent variability of diabetic foot infections and healing, making it difficult to sensitively capture changes in long‐term follow‐up. Moreover, clinical practice still relies heavily on expert judgment [35, 37]. Additionally, the lack of a gold standard, patient heterogeneity, insufficient systematic validation, and multidisciplinary standardization have collectively hindered the accumulation of robust evidence on the reliability, validity, and responsiveness of these tools [37]. Despite these limitations, they are widely used in both clinical practice and research to quantify the wound status, healing trajectory, and infection burden. Some instruments also incorporate domains overlapping with classification systems: the depth of ulcer, extent of bacterial colonization, phase, etiology (DEPA) tool includes ulcer depth and extent, whereas the DFUAS and Photographic Wound Assessment Tool (PWAT) capture wound characteristics alongside healing monitoring, and BWAT evaluates tissue quality and infection features relevant to classification [19, 23].
+
+Table 3 Classification and summary of measurement psychometric properties using COSMIN.
+
+Classifications	COSMIN measurement property	
+Reliability	Validity	Responsiveness	Interpretability	Overall rating	
+Internal consistency	Reliability	Measurement error	Content validity	Construct validity	Criterion validity	Responsiveness	
+Face validity	Structural validity	Hypotheses testing	Cross‐cultural validity	
+Screening Tools	
+UKST (the United Kingdom Screening Test)	NR	NR	NR	NR	NR	NR	NR	Insufficient	NR	NR	Insufficient	
+BFSC (Basic Foot Screening Checklist)	NR	Insufficient	NR	NR	NR	NR	NR	Insufficient	NR	NR	Insufficient	
+Q‐DFD (Questionnaire for Diabetes Related Foot Disease)	NR	Indeterminate (inconsistencies)	NR	Indeterminate	NR	Indeterminate (inconsistencies)	Sufficient	Indeterminate (inconsistencies)	NR	NR	NR or indeterminate	
+Risk stratification tools	
+ADA (American Diabetes Association System)	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+SIGN (Scottish Intercollegiate Grouping Network System)	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+IWGDF (International Working Group on Diabetic Foot)	NR	Insufficient	NR	NR	NR	NR	NR	Sufficient	NR	NR	Insufficient	
+SEWSS (Saint Elian Wound Score System)	NR	Sufficient	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+DUSS (Diabetic Ulcer Severity Score) †	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+WIfI (Wound, Ischemia, and foot Infection) Classification †	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+DiaFoRa (Diabetic Foot Risk Assessment)	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+S(AD)SAD (Size [Area, and Depth], Sepsis, Arteriopathy, Denervation system) †	NR	NR	NR	NR	NR	NR	NR	Insufficient	NR	NR	Insufficient	
+Wound Classification Tools	
+SINBAD (Site, Ischemia, Neuropathy, Bacterial Infection, and Depth) †	NR	Indeterminate (Inconsistencies)	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+(Meggitt‐) Wagner Classification	NR	Insufficient	NR	NR	NR	NR	NR	Indeterminate (inconsistencies)	NR	NR	insufficient	
+PEDIS (perfusion, extent, depth/tissue loss, infection, sensation classification) †	NR	Indeterminate (Inconsistencies)	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+UT (University of Texas) Classification	NR	Indeterminate (Inconsistencies)	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+CHS (Curative Health Services wound grade scale) †	NR	NR	NR	NR	NR	NR	NR	Indeterminate (inconsistencies)	NR	NR	NR or indeterminate	
+Infection or Healing Monitoring Tools	
+DEPA (depth of ulcer, extent of bacterial colonization, phase, etiology) †	NR	NR	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+DFUAS (Diabetic Foot Ulcer Assessment Scale) †	NR	Sufficient	NR	Indeterminate	NR	Sufficient	NR	Sufficient	NR	NR	NR or indeterminate	
+PWAT (Photographic Wound Assessment Tool) †	NR	Indeterminate (Inconsistencies)	NR	NR	NR	NR	NR	Sufficient	NR	NR	NR or indeterminate	
+CSSC (Clinical Signs and Symptoms Checklist)	NR	Insufficient	NR	NR	NR	NR	NR	Insufficient	NR	NR	insufficient	
+PUSH (Pressure Ulcer Scale for Healing)	NR	Indeterminate	NR	Indeterminate	Indeterminate	Sufficient	NR	Sufficient	Sufficient	NR	NR or indeterminate	
+BWAT (Bates‐Jensen Wound Assessment Tool)	NR	Insufficient	NR	Indeterminate	Indeterminate	Indeterminate	NR	Sufficient	NR	NR	Insufficient	
+DMIST (Diabetic Foot Ulcer Assessment Tool)	NR	Sufficient	NR	NR	NR	Sufficient	NR	Sufficient	NR	NR	NR or indeterminate	
+DESIGN tool	NR	Indeterminate	NR	NR	NR	Sufficient	NR	Sufficient	NR	NR	NR or indeterminate	
+Note: +, sufficient; −, insufficient; ?, indeterminate; †, some tools may fit into more than one category.
+
+Abbreviation: NR, not reported.
+
+In summary, despite the differences in structure and development objectives, these tools show significant redundancy in the areas of evaluation and convergence in clinical applications. They are primarily utilized for risk classification, healing monitoring, and treatment decisions, and can ultimately be utilized in a similar clinical context. Such redundancy, together with the limited scope of the psychometric evaluation, was consistently reflected in subsequent COSMIN‐based appraisals of these instruments.
+
+We evaluated the measurement properties of the 24 instruments used to assess diabetic foot within the COSMIN framework, with a focus on reliability, validity, responsiveness, and interpretability. Among the nine psychometric domains outlined by COSMIN, content validity, construct validity, and reliability were the most frequently evaluated. In contrast, measurement errors, cross‐cultural validity, and responsiveness were infrequently addressed or often not reported. Notably, no instrument demonstrated evidence across all nine measurement domains. A subset of tools, such as the DFUAS, Diabetic Foot Ulcer Assessment Tool (DMIST), and depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue (DESIGN) tools, showed relatively broader psychometric evaluation, particularly in reliability and construct validity domains. However, these tools lacked supporting data regarding measurement errors and cross‐cultural validity. Of all instruments reviewed, a substantial proportion had multiple domains with “not reported” (NR) or “indeterminate” (?) assessments, highlighting significant gaps in the psychometric evaluation of diabetic foot assessment tools.
+
+4. Discussion
+
+This umbrella review provides the first comprehensive synthesis of the measurement properties of instruments used for diabetic foot assessment by integrating evidence from systematic reviews published over the past 15 years. Across the 24 identified instruments, the findings revealed substantial heterogeneity in psychometric evaluation methods alongside widespread methodological limitations in the existing evidence base.
+
+4.1. Principal Findings and Their Significance
+
+The current landscape of diabetic foot assessment is marked by a paradox. Despite the proliferation of instruments designed to address the clinical imperative of systematic foot evaluation, few have undergone comprehensive psychometric scrutiny. Although the identified tools were grouped into four categories—screening, risk stratification, wound classification, and infection or healing monitoring–overlaps across domains were frequent, indicating that many instruments serve similar clinical purposes. For instance, wound classification systems such as SINBAD or PEDIS not only grade ulcer severity but also incorporate infection and ischemia status, thereby functioning simultaneously as infection monitoring tools [19, 23, 39]. Similarly, risk stratification frameworks often rely on variables such as ulcer history or peripheral arterial disease, which are also core parameters in wound classification systems, blurring the distinction between the two categories [23, 40]. This overlap underscores that these categories are not mutually exclusive but rather interdependent components of comprehensive diabetic foot care.
+
+More importantly, the psychometric evidence underlying these instruments remains limited. Content validity, construct validity, and reliability were the most frequently examined properties. However, they were often evaluated selectively and inconsistently across instruments [19, 23]. Measurement error, a core property for interpreting changes at the individual patient level, was virtually absent from the reported evaluations, whereas responsiveness was examined in only a small subset of tools [23, 41]. Moreover, despite its critical importance in a condition with global prevalence, cross‐cultural validity has been neglected. Given the multifactorial nature of diabetic foot complications arising from neuropathy, vasculopathy, biomechanical alterations, and immune dysfunction, assessment instruments must demonstrate robust validity and reliability across these domains to ensure accurate risk stratification and informed clinical decision‐making. A limited number of instruments, including the DFUAS, DMIST, and DESIGN, have undergone relatively broader psychometric evaluations. Nevertheless, the absence of a thorough quantification of measurement error and responsiveness testing raises uncertainty regarding their capacity to detect clinically meaningful changes over time [19, 23, 41]. These findings mirror the broader pattern observed in other areas of chronic disease assessment, where limited forms of validation often substitute for a comprehensive psychometric evaluation [42]. Similar methodological gaps have been reported in related fields such as pressure ulcer and peripheral arterial disease assessment [43], underscoring the persistent challenge of developing instruments with robust and generalizable measurement properties.
+
+In this context, it is crucial to consider whether the observed limitations reflect true methodological gaps or the inherent conceptual design of the instruments. The distinction between psychometric and clinimetric approaches is particularly relevant here. Although the COSMIN framework provides a structured methodology for evaluating measurement properties, not all instruments in this review were developed to measure latent constructs. Some tools—particularly those designed for risk stratification, classification, or clinical decision‐making—may be more appropriately characterized as clinimetric instruments. Although we utilized the COSMIN framework to ensure a consistent and systematic evaluation across heterogeneous instruments, certain properties, such as internal consistency or structural validity, may be less relevant for tools with a primarily clinical or composite structure. Consequently, the limited evidence in specific measurement domains should be interpreted with caution; these findings may reflect the conceptual intent and clinical function of the tools rather than mere methodological shortcomings. This underscores the necessity of balancing measurement rigor with clinical applicability when evaluating the quality of diabetic foot assessment tools.
+
+4.2. Methodological Quality and Implications
+
+Most of the included reviews displayed a moderate‐to‐high risk of bias. The COSMIN‐based assessment found no reviews with low risk, with approximately four out of five falling into the moderate range and the remainder showing high risk. The results of the ROBIS evaluation were more concerning, classifying nearly three quarters of the reviews as having a high risk of bias, with only one review meeting the low‐risk criteria. The common methodological weaknesses included missing or poorly described protocols, incomplete or language‐restricted search strategies, and the inconsistent application of validated appraisal frameworks. Several reviews lacked dual independent appraisals and, in many cases, the quality assessment findings were not integrated into the interpretation of the results. Such omissions increase the likelihood of overstating the clinical utility of certain instruments. The diversity of synthesis approaches also hinders meta‐analytical aggregation, limiting the ability to draw statistically robust conclusions regarding instrument performance.
+
+These methodological limitations are not entirely academic. As systematic reviews underpin guideline development and policy formulation, flaws in review methodology carry the risk of embedding suboptimal tools into clinical pathways, with downstream implications for patient safety and healthcare resource allocation.
+
+4.3. Clinical and Policy Implications
+
+The gaps identified in psychometric validation have direct consequences for patient care. Instruments without demonstrated reliability may yield inconsistent results between assessors or across time, delaying the identification of high‐risk patients, or prompting inappropriate escalation of care. Tools lacking established responsiveness may fail to detect treatment effects or disease progression, thereby undermining individual‐level management and population‐level surveillance [19, 44]. From a policy perspective, the absence of robust measurement foundations impedes cost‐effectiveness analyses that rely on precise and valid outcome measures to inform adoption and resource allocation. Healthcare systems risk investing in tools with limited clinical value or failing to adopt those with genuine potential to improve their outcomes. The absence of cross‐cultural validation further limits the harmonization of international diabetes care standards, potentially perpetuating inequities in high‐burden populations [45, 46].
+
+Several priorities emerge from this synthesis. First, comprehensive psychometric studies are urgently required for widely used instruments, particularly studies focusing on measurement errors and responsiveness. Such studies should apply rigorous methodological frameworks with adequate sample sizes and diverse clinical settings. Second, cross‐cultural validation is essential to ensure the equitable applicability of assessment tools across healthcare contexts, especially in low‐ and middle‐income countries where the diabetes burden is rapidly increasing. Third, direct comparative studies assessing multiple instruments in the same population could provide valuable evidence for informed tool selection. Finally, implementation research should investigate the barriers and facilitators to the adoption of psychometrically sound instruments in routine practice, ensuring that measurement quality translates into clinical utility.
+
+4.4. Strengths and Limitations
+
+This umbrella review applied dual appraisal frameworks (COSMIN and ROBIS), enabling the concurrent evaluation of instrument‐ and review‐level methodological quality. Restricting the inclusion of instruments to those assessed in multiple reviews enhanced reliability by reducing the influence of isolated findings. The focus on measurement properties rather than clinical outcomes alone ensured a targeted appraisal of psychometric robustness. However, this synthesis was constrained by the quality and completeness of the included systematic reviews. Variability in outcome definitions, reporting formats, and methodological approaches precluded meta‐analyses and necessitated narrative synthesis. Limiting the analysis to published systematic reviews may have led to the exclusion of recent primary studies that updated or refined the database. Differences in COSMIN applications further limit comparability across reviews. Although the four‐category classification was based on established guidelines and prior reviews, the categories were not entirely distinct. Overlaps between domains are unavoidable in infection and healing monitoring, particularly substantially intersecting wound classification. This conceptual overlap may limit the clarity of the framework and should be considered when interpreting the findings.
+
+5. Conclusions
+
+The results of this umbrella review highlight the substantial gaps in the psychometric evaluation of the tools used to assess diabetic foot, which are compounded by methodological shortcomings in supporting systematic reviews. Although certain tools show relatively strong evidence, none meet the full spectrum of the COSMIN criteria. The prevailing focus on content and construct validity, whereas neglecting measurement error, responsiveness, and cross‐cultural validity, is a serious limitation that may compromise clinical decision‐making and patient outcomes.
+
+Clinicians should exercise caution in instrument selection, recognizing that apparent clinical utility does not guarantee robust measurement performance. Healthcare organizations should prioritize tools with the strongest available evidence, while acknowledging the current limitations. Coordinated, methodologically rigorous validation studies, and high‐quality systematic reviews are required to establish a robust, evidence‐based foundation for diabetic foot assessment that supports effective care delivery and efficient resource use.
+
+Author Contributions
+
+Conceptualization: K.N. and S.Y.; methodology: K.N. and S.Y.; data curation: K.N. and S.Y.; formal analysis: K.N. and S.Y.; writing—original draft: K.N.; writing—review and editing: K.N. and S.Y.; supervision: S.Y.
+
+Funding
+
+This work was supported by the National Research Foundation of Korea (NRF) under Grant No. RS‐2026‐25476867.
+
+Disclosure
+
+The authors reviewed and approved all final content and take full responsibility for the manuscript.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Supporting information
+
+Supporting Information Additional supporting information can be found online in the Supporting Information section. Supplementary Material 1 Characteristics of diabetic foot measurement tools. Supplementary Material 2 The PRISMA‐COSMIN for OMIs 2024 statement checklist.
+
+Acknowledgments
+
+This work was supported by Chungnam National University. AI‐assisted language editing tools were used solely for English language refinement, including grammar correction and improvement of readability.
+
+Data Availability Statement
+
+The data that support the findings of this study are available from the corresponding author upon reasonable request. The umbrella review protocol is registered in PROSPERO (CRD420251073116).
+
+
+1 Parveen K. , Hussain M. A. , Anwar S. , Elagib H. M. , and Kausar M. A. , Comprehensive Review on Diabetic Foot Ulcers and Neuropathy: Treatment, Prevention and Management, World Journal of Diabetes. (2025) 16, no. 3, 100329, 10.4239/wjd.v16.i3.100329, 40093290.40093290 PMC11885961
+2 Schaper N. C. , van Netten J. J. , Apelqvist J. , Bus S. A. , Fitridge R. , Game F. , Monteiro-Soares M. , Senneville E. , and IWGDF Editorial Board , Practical Guidelines on the Prevention and Management of Diabetes-Related Foot Disease (IWGDF 2023 Update), Diabetes/Metabolism Research and Reviews. (2024) 40, no. 3, e3657, 10.1002/dmrr.3657, 37243927.37243927
+3 Dee T. M. , Theresia T. S. , and Probowati R. , Factors Associated With Foot Ulcer Among Diabetic Patients, International Journal of Nursing and Health Services (IJNHS). (2020) 3, no. 3, 358–363, 10.35654/ijnhs.v3i3.222.
+4 Zhang P. , Jing L. , Jing Y. , Tang S. , Zhu D. , and Bi Y. , Global Epidemiology of Diabetic Foot Ulceration: A Systematic Review and Meta-Analysis, Annals of Medicine. (2017) 49, no. 2, 106–116, 10.1080/07853890.2016.1231932, 27585063.27585063
+5 Nawaz A. D. , Zaidi A. , Elsayed B. , Jemmieh K. , and Eledrisi M. , Perspective Chapter: Epidemiology and Risk Factors of Diabetic Foot Ulcer, Diabetic Foot Ulcers-Pathogenesis, Innovative Treatments and AI Applications, 2024, IntechOpen, 10.5772/intechopen.1004009.
+6 Pitocco D. , Spanu T. , Di Leo M. , Raffaele Vitiello A. , Rizzi L. T. , Fiori B. , Caputo S. , Tinelli G. , and Zaccardi F. , Diabetic Foot Infections: A Comprehensive Overview, European Review for Medical & Pharmacological Sciences. (2019) 23, no. 2 Supplement, 26–37, 10.26355/eurrev_201904_17471, 30977868.30977868
+7 Edmonds M. , Manu C. , and Vas P. , The Current Burden of Diabetic Foot Disease, Journal of Clinical Orthopaedics and Trauma. (2021) 17, 88–93, 10.1016/j.jcot.2021.01.017, 33680841.33680841 PMC7919962
+8 Bus S. A. , Lavery L. A. , Monteiro-Soares M. , Rasmussen A. , Raspovic A. , Sacco I. C. N. , van Netten J. J. , and International Working Group on the Diabetic Foot , Guidelines on the Prevention of Foot Ulcers in Persons With Diabetes (IWGDF 2019 Update), Diabetes/Metabolism Research and Reviews. (2020) 36, no. Supplement 1, e3269, 10.1002/dmrr.3269, 32176451.32176451
+9 Yousif D. , Yousif Z. , and Joseph P. , Diabetic Foot Ulcer Neuropathy, Impaired Vasculature, and Immune Responses, Diabetic Foot Ulcers-Pathogenesis, Innovative Treatments and AI Applications, 2024, IntechOpen, 10.5772/intechopen.1003834.
+10 Mayrovitz H. N. , Wong S. , and Mancuso C. , Venous, Arterial, and Neuropathic Leg Ulcers With Emphasis on the Geriatric Population, Cureus. (2023) 15, no. 4, e38123, 10.7759/cureus.38123, 37252574.37252574 PMC10212749
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+13 Falcone M. , De Angelis B. , Pea F. , Scalise A. , Stefani S. , Tasinato R. , Zanetti O. , and Paola L. D. , Challenges in the Management of Chronic Wound Infections, Journal of Global Antimicrobial Resistance. (2021) 26, 140–147, 10.1016/j.jgar.2021.05.010.34144200
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+15 Johnson-Lynn S. E. , McCaskie A. W. , Coll A. P. , and Robinson A. H. N. , Neuroarthropathy in Diabetes: Pathogenesis of Charcot Arthropathy, Bone & Joint Research. (2018) 7, no. 5, 373–378, 10.1302/2046-3758.75.BJR-2017-0334.R1, 29922458.29922458 PMC5987696
+16 Vopat M. L. , Nentwig M. J. , Chong A. C. M. , Agan J. L. , Shields N. N. , and Yang S.-Y. , Initial Diagnosis and Management for Acute Charcot Neuroarthropathy, Kansas Journal of Medicine. (2018) 11, no. 4, 114–119, 10.17161/kjm.v11i4.8709, 30937152.30937152 PMC6276967
+17 Perveen W. , Ahsan H. , Rameen S. , Fayyaz S. , Zaif A. , Paracha M. A. , Nuhmani S. , Khan M. , and Alghadir A. H. , Prevalence of Peripheral Neuropathy, Amputation, and Quality of Life in Patients With Diabetes Mellitus, Scientific Reports. (2024) 14, no. 1, 14430, 10.1038/s41598-024-65495-2, 38910161.38910161 PMC11194260
+18 Crocker R. M. , Palmer K. N. B. , Marrero D. G. , and Tan T. W. , Patient Perspectives on the Physical, Psycho-Social, and Financial Impacts of Diabetic Foot Ulceration and Amputation, Journal of Diabetes and its Complications. (2021) 35, no. 8, 107960, 10.1016/j.jdiacomp.2021.107960, 34059410.34059410 PMC8316286
+19 Fernández-Torres R. , Ruiz-Muñoz M. , Pérez-Panero A. J. , García-Romero J. C. , and Gónzalez-Sánchez M. , Clinician Assessment Tools for Patients with Diabetic Foot Disease: A Systematic Review, Journal of Clinical Medicine. (2020) 9, no. 5, 10.3390/jcm9051487, 32429068.PMC7291260 32429068
+20 Abraham M. M. , Sudan S. H. H. , Pavithra V. , Nithya N. , Veeramani P. , and Murugeshan S. , Raghav A. , Assessment of Diabetic Foot, Diabetic Foot - Recent Advances, 2023, IntechOpen, 10.5772/intechopen.106731.
+21 Bus S. A. , Sacco I. C. N. , Monteiro-Soares M. , Raspovic A. , Paton J. , Rasmussen A. , Lavery L. A. , and van Netten J. J. , Guidelines on the Prevention of Foot Ulcers in Persons With Diabetes (IWGDF 2023 update), Diabetes/Metabolism Research and Reviews. (2024) 40, no. 3, e3651, 10.1002/dmrr.3651, 37302121.37302121
+22 Monteiro-Soares M. , Hamilton E. J. , Russell D. A. , Srisawasdi G. , Boyko E. J. , Mills J. L. , Jeffcoate W. , and Game F. , Guidelines on the Classification of Foot Ulcers in People With Diabetes (IWGDF 2023 Update), Diabetes/Metabolism Research and Reviews. (2024) 40, no. 3, e3648, 10.1002/dmrr.3648, 37179483.37179483
+23 Monteiro-Soares M. , Hamilton E. J. , Russell D. A. , Srisawasdi G. , Boyko E. J. , Mills J. L. , Jeffcoate W. , and Game F. , Classification of Foot Ulcers in People With Diabetes: A Systematic Review, Diabetes/Metabolism Research and Reviews. (2024) 40, no. 3, e3645, 10.1002/dmrr.3645, 37132179.37132179
+24 Fusar-Poli P. and Radua J. , Ten Simple Rules for Conducting Umbrella Reviews, Evidence Based Mental Health. (2018) 21, no. 3, 95–100, 10.1136/ebmental-2018-300014, 30006442.30006442 PMC10270421
+25 Belbasis L. , Bellou V. , and Ioannidis J. P. A. , Conducting Umbrella Reviews, BMJ Medicine. (2022) 1, no. 1, e000071, 10.1136/bmjmed-2021-000071, 36936579.36936579 PMC9951359
+26 Elsman E. B. M. , Mokkink L. B. , Terwee C. B. , Beaton D. , Gagnier J. J. , Tricco A. C. , Baba A. , Butcher N. J. , Smith M. , Hofstetter C. , Lee Aiyegbusi O. , Berardi A. , Farmer J. , Haywood K. L. , Krause K. R. , Markham S. , Mayo-Wilson E. , Mehdipour A. , Ricketts J. , Szatmari P. , Touma Z. , Moher D. , and Offringa M. , Guideline for Reporting Systematic Reviews of Outcome Measurement Instruments (OMIs): PRISMA-COSMIN for OMIs 2024, Journal of Clinical Epidemiology. (2024) 173, 111422, 10.1016/j.jclinepi.2024.111422, 38849061.38849061
+27 Page M. J. , McKenzie J. E. , Bossuyt P. M. , Boutron I. , Hoffmann T. C. , Mulrow C. D. , Shamseer L. , Tetzlaff J. M. , Akl E. A. , Brennan S. E. , Chou R. , Glanville J. , Grimshaw J. M. , Hróbjartsson A. , Lalu M. M. , Li T. , Loder E. W. , Mayo-Wilson E. , McDonald S. , McGuinness L. A. , Stewart L. A. , Thomas J. , Tricco A. C. , Welch V. A. , Whiting P. , and Moher D. , The Prisma 2020 Statement: An Updated Guideline For Reporting Systematic Reviews, British Medical Journal. (2021) 372, 10.1136/bmj.n71, 33782057.PMC8005924 33782057
+28 Mokkink L. B. , Elsman E. B. M. , and Terwee C. B. , COSMIN Guideline for Systematic Reviews of Patient-Reported Outcome Measures Version 2.0, Quality of Life Research. (2024) 33, no. 11, 2929–2939, 10.1007/s11136-024-03761-6, 39198348.39198348 PMC11541334
+29 Sánchez-Marco M. , Montoro-Pérez N. , Rubio-Aparicio M. , Cabañero-Martínez M. J. , Lozano-Casanova M. , and Escribano S. , Psychometric Properties of Instruments for Assessing the Methodological Quality and Risk of Bias in Non-Randomized Studies of Interventions: A Systematic Review and Meta-Analysis in Accordance With the COSMIN Guideline, Journal of Clinical Epidemiology. (2026) 194, 112230, 10.1016/j.jclinepi.2026.112230.41850546
+30 Glanville J. , Lefebvre C. , Manson P. , Robinson S. , and Shaw N. , ISSG Search Filter Resource, 2023, The InterTASC Information Specialists′ Sub-Group, https://sites.google.com/a/york.ac.uk/issg-search-filters-resource/home.
+31 Wang X. , Yuan C.-X. , Bin X. , and Zhi Y. , Diabetic Foot Ulcers: Classification, Risk Factors and Management, World Journal of Diabetes. (2022) 13, no. 12, 1049–1065, 10.4239/wjd.v13.i12.1049, 36578871.36578871 PMC9791567
+32 Whiting P. , Savović J. , Higgins J. , Caldwell D. , Reeves B. , Shea B. , Davies P. , Kleijnen J. , Churchill R. , and ROBIS group , ROBIS: A new Tool to Assess Risk of Bias in Systematic Reviews was developed, Journal of Clinical Epidemiology. (2016) 69, 225–234, 10.1016/j.jclinepi.2015.06.005, 26092286.26092286 PMC4687950
+33 Pérez-Panero A. J. , Ruiz-Muñoz M. , Fernández-Torres R. , Formosa C. , Gatt A. , and Gónzalez-Sánchez M. , Diabetic Foot Disease: A Systematic Literature Review of Patient-Reported Outcome Measures, Quality of Life Research. (2021) 30, no. 12, 3395–3405, 10.1007/s11136-021-02892-4, 34109501.34109501
+34 Tokuda T. , Hirano K. , Sakamoto Y. , Mori S. , Kobayashi N. , Araki M. , Yamawaki M. , and Ito Y. , Use of the Wound, Ischemia, Foot Infection classification System in Hemodialysis Patients After Endovascular Treatment for Critical Limb Ischemia, Journal of Vascular Surgery. (2018) 67, no. 6, 1762–1768, 10.1016/j.jvs.2017.09.037, 29224944.29224944
+35 Kosaji D. , Awad M. I. , Katmah R. , Jelinek H. F. , Fatima Domingues M. , Baguneid M. , Alanazi A. , and Khalaf K. , Diabetic Foot Prevention, Assessment, And Management Using Innovative Smart Wearable Technology: A Systematic Review, Journal of NeuroEngineering and Rehabilitation. (2025) 22, no. 1, 10.1186/s12984-025-01695-9, 40682082.PMC12273060 40682082
+36 Yotsu R. R. , Pham N. M. , Oe M. , Nagase T. , Sanada H. , Hara H. , Fukuda S. , Fujitani J. , Yamamoto-Honda R. , Kajio H. , Noda M. , and Tamaki T. , Comparison of Characteristics and Healing Course of Diabetic Foot Ulcers by Etiological Classification: Neuropathic, Ischemic, and Neuro-Ischemic Type, Journal of Diabetes and its Complications. (2014) 28, no. 4, 528–535, 10.1016/j.jdiacomp.2014.03.013, 24846054.24846054
+37 Maity S. , Leton N. , Nayak N. , Jha A. , Anand N. , Thompson K. , Boothe D. , Cromer A. , Garcia Y. , Al-Islam A. , and Nauhria S. , A Systematic Review of Diabetic Foot Infections: Pathogenesis, Diagnosis, and Management Strategies, Frontiers in Clinical Diabetes and Healthcare. (2024) 5, 1393309, 10.3389/fcdhc.2024.1393309, 39165660.39165660 PMC11333436
+38 Chuan F. , Tang K. , Jiang P. , Zhou B. , and He X. , Reliability and Validity of the Perfusion, Extent, Depth, Infection and Sensation (PEDIS) Classification System and Score in Patients With Diabetic Foot Ulcer, PloS One. (2015) 10, no. 4, e0124739, 10.1371/journal.pone.0124739, 25875097.25875097 PMC4395335
+39 Monteiro-Soares M. , Martins-Mendes D. , Vaz-Carneiro A. , Sampaio S. , and Dinis-Ribeiro M. , Classification Systems for Lower Extremity Amputation Prediction in Subjects With Active Diabetic Foot Ulcer: A Systematic Review and Meta-Analysis, Diabetes/Metabolism Research and Reviews. (2014) 30, no. 7, 610–622, 10.1002/dmrr.2535, 24523130.24523130
+40 Monteiro-Soares M. , Boyko E. J. , Ribeiro J. , Ribeiro I. , and Dinis-Ribeiro M. , Risk Stratification Systems for Diabetic Foot Ulcers: A Systematic Review, Diabetologia. (2011) 54, no. 5, 1190–1199, 10.1007/s00125-010-2030-3, 21249490.21249490
+41 Welling R. H. A. , van Breugel M. , van de Mortel M. , de Borst G. J. , Schmidt A. , van den Heuvel D. A. F. , and Bakker O. J. , A Systematic Review of the Accuracy of Prognostic Tests and Scoring Systems for Use in the Global Vascular Guidelines’ PLAN Concept for the Treatment of Chronic Limb Threatening Ischemia, Journal of Vascular Surgery. (2025) 81, no. 4, 987–998, 10.1016/j.jvs.2024.12.043, 39725246.39725246
+42 Kim S. H. , Lee B. G. , and Choe Y. H. , Psychometric Evaluation Of Patient Assessment of Chronic Illness Care Among Korean Cancer Survivors, PLoS One. (2021) 16, no. 8, e0256119, 10.1371/journal.pone.0256119, 34383868.34383868 PMC8360575
+43 Katsui S. , Inoue Y. , Igari K. , Toyofuku T. , Kudo T. , and Uetake H. , Novel Assessment Tool Based On Laser Speckle Contrast Imaging to Diagnose Severe Ischemia in the Lower Limb for Patients With Peripheral Arterial Disease, Lasers in Surgery and Medicine. (2017) 49, no. 7, 645–651, 10.1002/lsm.22669, 28370223.28370223 PMC5573943
+44 Jais S. and Pratama K. , A Diabetic Foot Wound Healing Assessment Tool: A Scoping Review, Heliyon. (2023) 9, no. 5, e15736, 10.1016/j.heliyon.2023.e15736, 37180932.37180932 PMC10172750
+45 Ma L. , Ma W. , Lin S. , Li Y. , and Ran X. , Adaptation and Validation of the Diabetic Foot Ulcer Scale-Short Form Scale for Chinese Diabetic Foot Ulcers Individuals, International Journal of Environmental Research and Public Health. (2022) 19, no. 21, 14568, 10.3390/ijerph192114568, 36361446.36361446 PMC9659257
+46 Ruiz-Muñoz M. , Fernández-Torres R. , Formosa C. , Gatt A. , Gijón-Noguerón G. , Navarro-Flores E. , and González-Sánchez M. , Validity and Reliability of the English Version of the Diabetic Foot Self-Care Questionnaire: A Cross-Cultural Adaptation, Frontiers in Public Health. (2023) 11, 1326439, 10.3389/fpubh.2023.1326439, 38332943.38332943 PMC10851747
diff --git a/corpus/healthcare/text/162d25b47e1ee1e0.txt b/corpus/healthcare/text/162d25b47e1ee1e0.txt
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@@ -0,0 +1,262 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: JBI Evid Synth
+Journal ID: JBI Evid Synth
+NLM Journal ID: 101764819
+Journal ID: SRX
+
+Jbi Evidence Synthesis
+
+EISSN: 2689-8381
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12888903
+PMID: 41362924
+DOI: 10.11124/JBIES-25-00015
+Article ID: JBIES-25-00015
+Article version: 1
+Article version: 3
+Subjects: Protocols
+
+Prevalence and types of prescribing errors made by non-medical prescribers in health care settings globally: a systematic review protocol
+
+https://orcid.org/0000-0002-2282-9579 Koskiniemi Saija 1 2
+https://orcid.org/0000-0001-5351-4468 Syyrilä Tiina 1 2
+https://orcid.org/0009-0006-5567-2033 Jukarainen Laura 1
+https://orcid.org/0000-0002-2892-1245 Franklin Bryony Dean 3 4
+https://orcid.org/0000-0003-3338-7443 Mykkänen Minna 5
+https://orcid.org/0000-0002-0725-1414 Jylhä Virpi 2 6
+https://orcid.org/0000-0001-8542-8193 Härkänen Marja 1 6
+1 Department of Nursing Science, University of Eastern Finland, Kuopio, Finland
+2 JBI Finnish Centre for Evidence-Based Health Care, Helsinki, Finland
+3 School of Pharmacy, University College London, London, UK
+4 NIHR North West London Patient Safety Research Collaboration, London, UK
+5 Wellbeing Services County of North Savo, Kuopio, Finland
+6 Research Centre for Nursing Science and Social and Health Management, Kuopio University Hospital, Wellbeing Services County of North Savo, Kuopio, Finland
+Correspondence: Saija Koskiniemi, saija.koskiniemi@uef.fi
+Publication date: 2026 Feb
+Electronic publication date: 2026 Feb 10
+Volume: 24
+Issue: 2
+First page: 349
+Last page: 358
+Copyright: Copyright © 2026 The Author(s). Published by Wolters Kluwer Health, Inc. on Behalf of JBI.
+Copyright year: 2026
+License: This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: errors, medication safety, non-medical prescriber, patient safety, prescribing
+OPEN-ACCESS: TRUE
+
+Ÿ==============================Ÿ
+Objective:
+
+The aim of this systematic review will be to establish the prevalence and types of prescribing errors made by non-medical prescribers in health care.
+
+Introduction:
+
+Prescribing errors are common, but the existing literature mostly focuses on medical prescribers. In many countries, legislation allows non-medical health care professionals to prescribe; however, there has been no systematic review of non-medical prescribing errors.
+
+Eligibility criteria:
+
+This review will include quantitative studies of all designs investigating the prevalence of prescribing errors related to any disease, medication, or patient group made by non-medical prescribers in all health care settings globally.
+
+Methods:
+
+This systematic review will include a Study Within a Review. We will use JBI methodology for systematic reviews, particularly the guidelines for prevalence estimate reviews. An information specialist will conduct standard database searches using PubMed, CINAHL (EBSCOhost), Scopus, and Web of Science Core Collection. Two researchers will perform a parallel search using artificial intelligence software. Studies found through standard database searches and those found using artificial intelligence will be included if the 2 researchers independently decide that they meet the eligibility criteria after full-text screening. A comparison of the standard database search and artificial intelligence search will be reported in a separate Study Within a Review. Two researchers will independently conduct the critical appraisals and data extraction. A meta-analysis will be conducted, if possible, otherwise, a narrative synthesis will be used.
+
+Review registration:
+
+PROSPERO CRD42024616617
+
+Introduction
+
+Medication errors are a serious but avoidable problem in health care. Worldwide, the annual cost of medication errors has been estimated to be US$42 billion.1 Medication errors include errors in administration, prescribing, transcribing, dispensing, and monitoring practices.1 Prescribing errors are a global problem, with the median error rate being 7% to 32% of medication orders, as reported in previous systematic reviews on paper-based prescribing.2,3 While prescribing errors have been extensively studied among physicians,4-9 less is known about the prevalence and types of errors made by non-medical prescribers. Definitions of prescribing errors vary across studies; consequently, investigating the prevalence of prescribing errors is challenging.10,11
+
+Prescribing errors most commonly involve incorrect dosage, strength,2,10 or medication selection, and are most commonly related to antibiotics and analgesics,11 which may reflect these being the most commonly used groups of drugs. Prescriber-related factors, such as insufficient knowledge, prescribing skills, and experience, have been found to influence in-hospital prescribing errors in a systematic review.12 The review did not consider that, currently, prescribers’ backgrounds can vary significantly, with prescribers being either medical or non-medical.
+
+Dentists and physicians are considered medical prescribers. Other health care professionals with a qualification to prescribe are generally referred to as non-medical prescribers with legal prescribing rights, such as nurses, pharmacists, and occupational therapists.13 According to Ecker et al.,13 of 117 countries in a scoping review, 99 have some non-medical prescribing practices, although prescribing rights and levels vary. Non-medical prescribers may have full or nearly full prescribing rights, have more limited prescribing rights for particular medicines, or can continue medicines initiated by another prescriber.14 Independent prescribing refers to the practice of the prescriber autonomously prescribing medications. Prescribers with supplementary prescribing rights can, for example, renew prescriptions or prescribe under the supervision of a medical prescriber.14 Unlike independent and supplementary prescribing, health care professionals following patient group directions do not prescribe medicines. Patient group directions enable the administration of specific patient groups in specific situations using specified medicines.15
+
+As the number of non-medical prescribers is increasing, it is essential to understand the safety and quality of non-medical prescribing practices. Reported prescribing error rates vary significantly across non-medical professions, but also across different counties. For example, in the critical care setting in the UK, the prescribing error rate of advanced nurse practitioners (0.6%) was statistically significantly lower than that of consults (6.8%) and other medical prescribers (3.4%), where the overall error rate was 2.8%.16 Another study conducted in critical care in the UK found a low prescribing error rate (0.18%) among pharmacists.17 The third study from the UK supports the finding that pharmacists have a low prescribing error rate (0.7%), also across the acute hospital setting.18 In contrast, neonatal nurse practitioners’ prescribing error rate was 16%, but still remarkably lower than pediatric residents’ error rate (39%) in the US.19 In digital health services, nurse practitioners’ error rate was lower (14.22%) compared to general practitioners (21.37%) in Australia.20 Current evidence of non-medical prescribing errors remains fragmented, as no other systematic review has focused on this topic. Thus, a systematic review is necessary to compile the existing knowledge, identify research gaps, and guide future policy and practice regarding non-medical prescribing.
+
+A preliminary search of PROSPERO, PubMed, and JBI Evidence Synthesis was conducted, and no current or in-progress systematic review on the topic were identified. Prior systematic reviews have focused on the prevalence and incidence of prescribing errors with high-risk medicines in hospitals5 and prescribing errors in handwritten prescriptions in primary or secondary care21 made by medical prescribers. Systematic reviews of prescribing errors among adults and children as hospital inpatients using paper prescriptions,3 types and causes of prescribing errors associated with computerized provider order entry systems,22 and factors influencing prescribing errors in hospitals23 did not define whether prescribers were medical or non-medical. None of the systematic reviews have focused on the prevalence and incidence of prescribing errors made by non-medical prescribers.
+
+This review’s objective is to establish the prevalence and types of prescribing errors made by non-medical prescribers in health care.
+
+Review questions
+
+What is the prevalence of prescribing errors made by non-medical prescribers in all health care settings globally?
+
+What types of prescribing errors are made by non-medical prescribers in all health care settings globally?
+
+Eligibility criteria
+
+Population
+
+The population of this review will include non-medical prescribers, such as nurses, pharmacists, physiotherapists, occupational therapists, paramedics, optometrists, podiatrists, radiographers, and other allied health professionals. Medical prescribers, including physicians, dentists, and medical or dental students, will be excluded. All levels of non-medical prescribing (independent and supplementary) will be included. Independent prescribing rights, therefore, refer to a non-medical prescriber autonomously prescribing a medicine. In contrast, supplementary rights refer to a non-medical prescriber continuing a medicine initiated by another prescriber, renewing a prescription, prescribing under supervision, or prescribing limited medicines. A combination of independent and supplementary non-medical prescribing rights may also be included. Non-medical health professionals who follow patient group directions will be excluded.
+
+Condition
+
+The condition of this review will include prescribing errors related to any disease, medication, or patient group. Different definitions of prescribing errors have made synthesis in systematic reviews more difficult.3,9 In this study, we will use the definition by Dean et al.10 of prescribing error, defined as an unintentional result of a prescribing decision or prescription writing process that causes a “reduction in the probability of treatment being timely and effective”(p.235) or causes an increase in the risk of harm [to the patient] when compared with generally accepted practice.”(p.235) The included studies do not have to cite this definition precisely; however, the definition must be conceptually similar. Dean et al.10 present scenarios for situations that meet or do not meet their definition of a prescribing error. We will only consider studies that include descriptions of prescribing errors or when descriptions meet situations mentioned in the paper by Dean et al.10 (“Situations that should be included as prescribing errors”[p.236] or “Situations that may be considered prescribing errors, depending on the individual clinical situation”[p.236]). The error types, with examples, are available in Appendix I. If a study does not include descriptions of prescribing errors or none of the described prescribing errors meet the situation described by Dean et al.,10 it will be excluded. All period, point, and lifetime prevalence studies will be accepted.
+
+Context
+
+All health care settings, including digital services, in all countries will be included.
+
+Types of studies
+
+Research papers will be eligible if they describe observational and experimental study designs reporting the prevalence or incidence of prescribing errors among non-medical prescribers. Studies that include medical and non-medical prescribing errors will be included if they allow the data to be extracted separately for non-medical prescribers. Studies on medication errors more generally will be included if it is possible to separate the data relating to prescribing errors. Studies based on self-reporting of errors will be excluded unless the number of studies using other methods for identifying prescribing errors is too few (fewer than 5 studies) for analysis. Gray literature, such as dissertations, theses, government reports, and conference papers, will also be excluded.
+
+Methods
+
+The proposed systematic review will be conducted in accordance with the JBI methodology for systematic reviews, particularly following the guidance for prevalence estimate reviews.24,25 The review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.26 The review protocol has been registered in PROSPERO (CRD42024616617). Alongside this review, a Study Within a Review (SWAR)27 will be conducted to explore the suitability of using artificial intelligence (AI tools when searching for scientific articles to include in systematic reviews as an adjunct to the standard database search process. The SWAR is registered in the SWAR Store (registration number: SWAR43).28
+
+Search strategy
+
+The search strategy will aim to locate peer-reviewed published studies. The searches will be conducted separately but in parallel, using a standard database search and an AI search (Figure 1). The search strategy has been developed together with an information specialist. Studies published in all languages and for all dates will be accepted. Figure 1 Data sources and study selection
+
+To conduct the database search, a 3-step search strategy will be used. First, an initial limited PubMed search was undertaken in February 2024 to identify articles on the topic. Second, the text words contained in the titles and abstracts of relevant articles and the index terms used to describe the articles were used to develop a full search strategy for PubMed, CINAHL(EBSCOhost), Web of Science Core Collection, and Scopus. A sample search strategy for CINAHL (EBSCOhost) is available in Appendix II. The search strategy, including all identified keywords and index terms, will be adapted for each included database and information source. The information specialist will conduct the final search in the databases. Third, the references of studies included in this review and systematic reviews on similar topics will be screened for additional studies.
+
+To conduct the AI search, 2 researchers will use free versions of Connected Papers (Connected Papers, Israel), Elicit (Ought, SF, USA), Keenious (Keenious, Norway), Open Knowledge Maps (Open Knowledge Maps, Austria), Scopus AI (Elsevier, Singapore), Research Assistant (Clarivate, UK), and ResearchRabbit (ResearchRabbit, WA, USA).
+
+Study selection
+
+Study selection from the results of the standard database search and the AI search will be made separately, but in parallel. Following the database search, all identified citations will be collated and uploaded into Covidence (Veritas Health Innovation, Melbourne, Australia), where duplicates will be removed. Subsequently, citations will be imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI; JBI, Adelaide, Australia).29 Following a pilot test, 2 reviewers will independently screen all titles and abstracts against the eligibility criteria. Before commencing the screening, however, both reviewers will also familiarize themselves with the definition and examples of prescribing errors,3 and only studies using that definition will be included. The same 2 reviewers will independently assess the full texts of selected citations in detail against the eligibility criteria. Reasons for excluding papers at full-text screening will be recorded and reported. Any disagreements between the reviewers at each stage of the selection process will be resolved through discussion or with a third independent reviewer. The search results and the study inclusion process will be reported in full in the final systematic review and presented in a PRISMA flow diagram.26 All papers passing the study selection process described here will be included, whether they are identified via the standard database search or the AI search alone, or both. Detailed results of the AI search will be reported in a separate SWAR article.
+
+Assessment of methodological quality
+
+After a pilot test, 2 reviewers will independently conduct critical appraisal of eligible studies at the study level for methodological quality using the standardized critical appraisal instrument from JBI for prevalence studies24 in JBI SUMARI.29 The appraisal instrument will not be chosen based on the study design, but to evaluate the studies’ methodological rigor in relation to examining the prevalence of prescribing errors.30
+
+Articles reporting incidence will be evaluated using the JBI critical appraisal tools based on the type of study design, including randomized controlled trials,31 quasi-experimental,32 cohort,33 and analytical cross-sectional studies.33 Authors of papers will be contacted via email to request missing or additional data for clarification, where required, and then followed up once. Any disagreements that arise will be resolved through discussion between the 2 reviewers. All studies, regardless of their methodological quality, will undergo data extraction and synthesis. The critical appraisal results will be reported descriptively and in a table.
+
+Data extraction
+
+Two reviewers will independently extract the data from the included studies using the standardized data extraction tool for prevalence and incidence available in JBI SUMARI.29 The extracted data will include specific details about the source of reference, context, data collection date in each study, populations, study methods, prevalence, incidence, and types of prescribing errors. In addition to the fields in the standardized data extraction tool, we will extract information on countries, the profession of prescribers, the level and details of prescribing rights (eg, independent, supplementary), type of prescribing error, prevalence and incidence of prescribing errors, how errors were detected, prescribing error situations (eg, admission, discharge), and type of prescription system (eg, electronic, paper).
+
+The data extraction tool will be piloted on 5 studies by the reviewers. Authors of papers will be contacted to request missing or additional data, where required, and then followed up once. Three authors will independently test the data extraction form before using it. Any disagreements that arise between the reviewers will be resolved through discussion.
+
+Data synthesis
+
+Where possible, the studies will be pooled in a statistical meta-analysis using JBI SUMARI.29 The total number of prescribing errors and non-medical prescribers will be calculated across all studies. The pooled prevalence of prescribing errors will be expressed as a proportion with 95% CI. The data will be transformed using the Freeman–Turkey transformation. The heterogeneity of the studies will be assessed using the standard I2 test. The I2 test scores of 25%, 50%, and 75% will be considered low, moderate, and high. Subcategories (eg, level of prescribing right, patient group, country) will be examined, if feasible. Publication bias will be investigated with an appropriate statistical test (eg, Egger test) and the Doi plot generated using R software v.3.6.1. (R Foundation for Statistical Computing, Vienna, Austria).
+
+Narrative synthesis will be conducted where statistical pooling is not possible. The results will then be presented in narrative format, including tables and figures. The data synthesis will focus on grouping error rates and types based on the studies’ similarities. Studies will be grouped into errors occurring in inpatient, outpatient, long-term, and home care, as well as in digital health services (eg, telemedicine, phone- or chat-based appointments). The studies will be further grouped according to the level of the prescribing right; the type of error; patient group; and prescription system type. If possible, information on prescribing error situations (eg, admission, discharge) will be collected and used in grouping. Further grouping will be considered based on the extracted data from the included studies. The synthesized findings will be compared with the findings of systematic reviews of prescribing errors made by medical prescribers.2,9
+
+Funding
+
+The Wellbeing Service County of North Savo, Research Centre for Nursing Science and Social and Health Management, funded an information specialist. BDF is funded by the National Institute for Health and Care Research (NIHR) North West London Patient Safety Research Collaboration. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Research Council of Finland funds TS and MH.
+
+Acknowledgments
+
+In the memory of the information specialist, Maarit Putous (University of Eastern Finland), whose original idea was to combine standard database searches and use AI tools in this systematic review. Information specialist, Heikki Laitinen (University of Eastern Finland), for planning our search strategy.
+
+Author contributions
+
+Planning of the review and search strategy, and writing the protocol: all authors. Pilot search: SK and an information specialist. All authors have approved the final version.
+
+Appendix I: Draft data extraction form
+
+Authors		
+Year of publication		
+Date of data extraction		
+Journal		
+Country		
+Study method		
+Data collection date		
+Health care context		
+Number of non-medical prescribers	n =	
+Profession of non-medical prescribers		
+Level of prescribing right	Details (eg, independent, supplementary)	
+Type of prescribing error (according to Dean et al.’s10 definition)	1. Inappropriate medication for the patient	
+• The medication was contraindicated (eg, warfarin is prescribed to a patient with active gastrointestinal bleeding).	
+• No indication for prescribed medication (eg, prescribing amoxicillin for viral pharyngitis).	
+• The patient had a known allergy to the medication (eg, prescribing ibuprofen to a patient with a known NSAID allergy).	
+• The medication had a potential drug interaction (eg, simvastatin was prescribed together with clarithromycin).	
+• The medication and/or the dose were inappropriate for the patient’s renal function (eg, metformin was prescribed to a patient with severe renal impairment).	
+• Incorrect dose (eg, the dose below recommended for the patient’s clinical condition, overdose with narrow therapeutic index, no dose adjustment after abnormal levels).	
+• Continuing a drug despite adverse reaction (eg, clarithromycin was continued despite the patient getting a rash).	
+• Unnecessary duplicate medication when one was sufficient (eg, prescribing both ibuprofen and naproxen for pain).	
+2. Failure in prescription writing	
+• Drug, dose, or route not as intended	
+• Omission of indicated medication for a clinical condition	
+• Illegible prescription	
+• Misspelled medication (eg, amoxcillin was prescribed instead of amoxicillin)	
+• Drug name written using abbreviations or non-standard nomenclature (eg, MTX was prescribed instead of methotrexate)	
+• Ambiguous medication order	
+• Prescribed “1 tablet” when multiple strengths exist	
+• Prescribed “milligrams” when “micrograms” was intended	
+• Dose cannot be administered using available dosage forms	
+• Dose regimen not recommended for the prescribed formulation (eg, medication needing multiple daily doses was prescribed once-daily dosing)	
+• Route of administration omitted for drug with multiple routes	
+• Prescription continued longer than necessary (eg, amoxicillin prescribed for 10 days instead of the recommended 5)	
+• Duration of intermittent IV infusion not specified	
+• Timing in relation to meals was not specified	
+• Prescriber’s signature omitted	
+3. Failure regarding transcription	
+• Omission of a pre-admission medication upon hospital admission (eg, the patient’s antihypertensive medication was not continued upon hospital admission)	
+• Continuation of a general practitioner’s prescribing error upon hospital admission	
+• Incorrect transcription when rewriting the medication chart (eg, insulin was transcribed as 10 units instead of the prescribed 1 unit)	
+• Discharge prescription unintentionally deviated from the inpatient chart (eg, the discharge prescription omitted the patient’s regular anticoagulant medication that was continued during hospitalization)	
+• Medication order upon admission deviates from pre-admission prescription (eg, the patient’s pre-admission antidepressant was replaced with a different preparation without a documented rationale)	
+Prevalence of prescribing errors		
+Incidence of prescribing errors		
+Prescribing error situation	eg, admission or discharge	
+How errors were detected		
+Type of prescription system	eg, electronic or paper	
+IV, intravenous; NSAID, nonsteroidal anti-inflammatory drug.
+
+Appendix II: Search strategy
+
+CINAHL (EBSCOhost)	
+Search conducted: June 10, 2025	
+#	Query	Records retrieved	
+1	Non-Medical Prescribers [MeSH] OR Non-Medical Prescribing [MeSH] OR Supplementary Prescribing [MeSH]	96	
+2	(nonmedical OR “non medical” OR “not medical” OR “non physician*” OR “not physician*” OR “non dentist*” OR nurse* OR “nursing staff” OR “nursing personnel” OR pharmacist* OR “pharmac* staff” OR “pharmac* personnel” OR physiotherapist* OR “physical therapist*” OR “occupational therapist*” OR “allied health personnel” OR “allied health staff” OR “allied health occupation*” OR “allied health professional” OR paramedic* OR optometrist* OR podiatrist* OR radiographer*) N5 prescri*	14,680	
+3	#1 OR #2	14,680	
+4	prescri* N5 (error* OR erroneous* OR flaw* OR fault* OR mistake* OR incorrect* OR false OR wrong)	1659	
+5	Inappropriate Prescribing [MeSH] OR Over Prescribing [MeSH]	4015	
+6	#4 OR #5	5594	
+7	Prevalence [MeSH] OR Prevalence Studies [MeSH] OR Incidence [MeSH]	186,963	
+8	Prevalence OR Incidence	511,629	
+9	#7 OR #8	511,629	
+10	#3 AND #6 AND #9	767	
+
+The authors declare no conflicts of interest.
+
+
+References
+
+1. World Health Organization. Medication without harm: global patient safety challenge on medication safety [internet]. WHO; 2017 [cited 2024 Dec 1]. https://www.who.int/initiatives/medication-without-harm.
+2. Alhomoud FK Alnemari W Alfahmi H Alhomoud F Cheema E. Incidence and prevalence of prescribing errors in Saudi Arabia: a systematic study. Int J Pharm Pharm Sci 2016;8(12):194.
+3. Lewis PJ Dornan T Taylor D Tully MP Wass V Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf 2009;32(5):379-89.19419233 10.2165/00002018-200932050-00002
+4. Simegn W Weldegerima B Seid M Zewdie A Wondimsigegn D Abyu C Assessment of prescribing errors reported by community pharmacy professionals. J Pharm Policy Pract 2022;15(1):62.36243738 10.1186/s40545-022-00461-9 PMC9569042
+5. Cope LC Abuzour AS Tully MP. Non-medical prescribing: where are we now? Ther Adv Drug Saf 2016;7(4):165-72.27493720 10.1177/2042098616646726 PMC4959632
+6. Canales-Siguero MD García-Muñoz C Caro-Teller JM Piris-Borregas S Martín-Aragón S Ferrari-Piquero JM Electronic prescribing in the neonatal intensive care unit: analysis of prescribing errors and risk factors. J Med Syst 2025;49(1):26.39964641 10.1007/s10916-025-02161-8
+7. Zaal RJ van der Kaaij ADM Evenhuis HM van den Bemt PMLA . Prescription errors in older individuals with an intellectual disability: prevalence and risk factors in the Healthy Ageing and Intellectual Disability Study. Res Dev Disabil 2013;34(5):1656-62.23501585 10.1016/j.ridd.2013.02.005
+8. Salam M Al Anazi M Al-Jeraisy M . Prevalence and predictors of antibiotic prescription errors in an emergency department, Central Saudi Arabia. Drug Healthc Patient Saf 2015;7:103-11.26082662 10.2147/DHPS.S83770 PMC4461133
+9. Babatunde KM Akinbodewa AA Akinboye AO Adejumo AO . Prevalence and pattern of prescription errors in a Nigerian kidney hospital. Ghana Med J 2016;50(4):233-7.28579629 10.4314/gmj.v50i4.6 PMC5443671
+10. Dean B Barber N Schachter M. What is a prescribing error? Qual Health Care 2000;9(4):232-7.11101708 10.1136/qhc.9.4.232 PMC1743540
+11. Yikna BB Abay WA Awgichew SY. Medicine prescribing practices and prescription errors evaluations at outpatient department in Debre Berhan Comprehensive Specialized Hospital, Amhara Regional State, Ethiopia. J Pharm Pract 2025;38(1):81-92.39115938 10.1177/08971900241273176
+12. Franklin BD Reynolds M Shebl NA Burnett S Jacklin A. Prescribing errors in hospital inpatients: a three-centre study of their prevalence, types and causes. Postgrad Med J 2011;1033(87):739-45.10.1136/pgmj.2011.117879 21757461
+13. Ecker S Joshi R Shanthosh J Ma C Webster R. Non-medical prescribing policies: a global scoping review. Health Policy 2020;124(7):721-6.32471762 10.1016/j.healthpol.2020.04.015
+14. Maier CB. Nurse prescribing of medicines in 13 European countries. Hum Resour Health 2019;17(1):95.31815622 10.1186/s12960-019-0429-6 PMC6902591
+15. National Institute for Health and Care Excellence. Patient group directions [internet]. NICE; 2017 [cited 2025 Jan 4]. Available from: https://www.nice.org.uk/guidance/mpg2/resources/patient-group-directions-pdf-1779401941189.
+16. Carberry M Connelly S Murphy J. A prospective audit of a nurse independent prescribing within critical care. Nurs Crit Care 2013;18(3):135-41.23577948 10.1111/j.1478-5153.2012.00534.x
+17. Cross VJ Parker JT Law Min MYL Bourne RS. Pharmacist prescribing in critical care: an evaluation of the introduction of pharmacist prescribing in a single large UK teaching hospital. Eur J Hosp Pharm 2018;25(e1):e2-e6.10.1136/ejhpharm-2017-001267 PMC6457156 31157059
+18. Turner E Kennedy MC Barrowcliffe A. An investigation into prescribing errors made by independent pharmacist prescribers and medical prescribers at a large acute NHS hospital trust: a cross-sectional study. Eur J Hosp Pharm 2021;28(3):149-53.
+19. Brown CL Garrison NA Hutchison AA. Error reduction when prescribing neonatal parenteral nutrition. Am J Perinatol 2007;24(7):417-27.17624817 10.1055/s-2007-984404
+20. Talay L Vickers M Lu D. Nurse practitioner and general practitioner error rates in a large digital health service: a retrospective cohort analysis. Nurs Rep 2024;14(4):3407-16.39585137 10.3390/nursrep14040246 PMC11587444
+21. El Abdouni S Kalfsvel LS Rietdijk WJR van der Kuy H van Rosse F. Differences in prescribing errors between electronic prescribing and traditional prescribing among medical students: a randomized pilot study. Br J Clin Pharmacol 2024;91(8):2109-18.38520277 10.1111/bcp.16053 PMC12304864
+22. Brown CL Mulcaster HL Triffitt KL Sittig DF Ash JS Reygate K A systematic review of the types and causes of prescribing errors generated from using computerized provider order entry systems in primary and secondary care. J Am Med Inform Assoc 2017;24(2):432-40.27582471 10.1093/jamia/ocw119 PMC7651904
+23. Mahomedradja RF Schinkel M Sigaloff KCE Reumerman MO Otten RHJ Tichelaar J Factors influencing in-hospital prescribing errors: a systematic review. Br J Clin Pharmacol 2023;89(6):1724-35.36805648 10.1111/bcp.15694
+24. Munn Z Moola S Lisy K Riitano D Tufanaru C. Systematic reviews of prevalence and incidence. In: Aromataris E Lockwood C Porritt K Pilla B Jordan Z , editors. JBI Manual for Evidence Synthesis [internet]. JBI; 2024 [cited 2025 Jan 4]. Available from: https://synthesismanual.jbi.global.
+25. Migliavaca CB Stein C Colpani V Barker TH Munn Z Falavigna M How are systematic reviews of prevalence conducted? A methodological study. BMC Med Res Methodol 2020;20(1):96.32336279 10.1186/s12874-020-00975-3 PMC7184711
+26. Page MJ McKenzie JE Bossuyt PM Boutron I Hoffmann TC Mulrow CD The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.33782057 10.1136/bmj.n71 PMC8005924
+27. Devane D Burke NN Treweek S Clarke M Thomas J Booth A Study within a review (SWAR). J Evid Based Med 2022;15(4):328-32.36513956 10.1111/jebm.12505 PMC10107874
+28. The Northern Ireland Hub for Trials Methodology Research. SWAR store [internet]. MRC; 2024 [cited 2024 Oct 15]. Available from: https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWARStore/.
+29. Munn Z Aromataris E Tufanaru C Stern C Porritt K Farrow J The development of software to support multiple systematic review types: the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI). Int J Evid Based Healthc 2019;17(1):36-43.30239357 10.1097/XEB.0000000000000152
+30. Migliavaca CB Stein C Colpani V Munn Z Falavigna M , Prevalence Estimates Reviews – Systematic Review Methodology Group (PERSyst). Quality assessment of prevalence studies: a systematic review. J Clin Epidemiol 2020;127: 59-68.32679313 10.1016/j.jclinepi.2020.06.039
+31. Barker TH Stone JC Sears K Klugar M Tufanaru C Leonardi-Bee J The revised JBI critical appraisal tool for the assessment of risk of bias for randomized controlled trials. JBI Evid Synth 2023;21(3):494-506.36727247 10.11124/JBIES-22-00430
+32. Barker TH Habibi N Aromataris E Stone JC Leonardi-Bee J Sears K The revised JBI critical appraisal tool for the assessment of risk of bias quasi-experimental studies. JBI Evid Synth 2024;22(3):378-88.38287725 10.11124/JBIES-23-00268
+33. Moola S Munn Z Tufanaru C Aromataris E Sears K Sfetcu R Chapter 7: Systematic reviews of etiology and risk. In: Aromataris E Lockwood C Porritt K Pilla B Jordan Z , editors. JBI Manual for Evidence Synthesis [internet]. JBI; 2024 [cited 2025 Jan 4]. Available from: https://synthesismanual.jbi.global.
diff --git a/corpus/healthcare/text/1e3e01f9bc7d52ca.txt b/corpus/healthcare/text/1e3e01f9bc7d52ca.txt
new file mode 100644
index 0000000000000000000000000000000000000000..60ad53e44c91abfe295ac62a467e13ad373d39ed
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@@ -0,0 +1,420 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Assist Reprod Genet
+Journal ID: J Assist Reprod Genet
+NLM Journal ID: 9206495
+
+Journal of Assisted Reproduction and Genetics
+
+ISSN: 1058-0468
+EISSN: 1573-7330
+Publisher: Springer
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC10440310
+PMID: 37382788
+DOI: 10.1007/s10815-023-02834-8
+Article ID: 2834
+Article version: 1
+Subjects: Assisted Reproduction Technologies
+
+Mapping international research output within ethical, legal, and social implications (ELSI) of assisted reproductive technologies
+
+http://orcid.org/0000-0001-6603-7496 Alon Ido idoalon77@gmail.com
+1 2
+Chebance Zacharie 3
+Massucci Francesco Alessandro 4
+Bounartzi Theofano 5
+Ravitsky Vardit 2 6
+1 grid.5515.4 0000000119578126 Department of Development Economics, Autonomous University of Madrid, Madrid, Spain
+2 grid.14848.31 0000 0001 2292 3357 University of Montreal, Montreal, Canada
+3 grid.58140.38 0000 0001 2097 6957 Mines Paristech, Paris, France
+4 SIRIS Lab, Research Division of SIRIS Academic, Barcelona, Spain
+5 grid.410558.d 0000 0001 0035 6670 Department of Obstetrics and Gynaecology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
+6 grid.38142.3c 000000041936754X Harvard Medical School, Boston, MA USA
+Electronic publication date: 2023 Jun 29
+Print publication date: 2023 Sep
+Volume: 40
+Issue: 9
+First page: 2023
+Last page: 2043
+Received 2022 Dec 28; Accepted 2023 May 19
+Copyright: © The Author(s) 2023
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Assisted reproductive technologies; Ethical, social, and legal implications; Mapping; Topic modeling; Geographic distribution of research; International research
+
+Funding: Universidad Autónoma de Madrid Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature.
+
+issue-copyright-statement: © Springer Science+Business Media, LLC, part of Springer Nature 2023
+
+Ÿ==============================Ÿ
+Purpose
+
+Research about ethical, legal, and social implications (ELSI) of assisted reproductive technologies (ART) is influenced by cultural and value-based perspectives. It impacts regulations, funding, and clinical practice, and shapes the perception of ART in society. We analyze trends in the global literature on ELSI of ART between 1999 and 2019. As most output is produced by North America, Western Europe, and Australia, we focus on international research, i.e., academic articles studying a different country than that of the corresponding author.
+
+Methods
+
+The corpus, extracted from PubMed, Web of Science, and Scopus, includes 7714 articles, of which 1260 involved international research. Analysis is based on titles, abstracts and keywords, classification into ART fields and Topic Modeling, the countries of corresponding author, and countries mentioned in abstracts.
+
+Results
+
+An absolute increase in the number of international studies, and their relative proportion. Trends of decentralization are apparent, yet geographic centralization remains, which reflects an unequal distribution of research funds across countries and may result in findings that do not reflect global diversity of norms and values. Preference for studying conceptual challenges through philosophical analysis, and for fields that concern only a portion of ART cycles. Less attention was dedicated to economic analysis and barriers to access, or to knowledge of and attitudes. International studies provide an opportunity to expand and diversify the scope of ELSI research.
+
+Conclusion
+
+We call on the research community to promote international collaborations, focus on less explored regions, and divert more attention to questions of cost, access, knowledge, and attitudes.
+
+Introduction
+
+Assisted reproductive technologies (ART) are raising many ethical, legal, and social implications (ELSI) that have been increasingly studied under the lens of humanities and social sciences. In the last two decades, ART practices around the world have increased considerably [1–4]. At the same time, with the global growth in academic publications [5, 6], the volume of research output about both technical and non-technical aspects of ART has expanded substantially [7].
+
+A significant share of research in ART is dedicated to bioethical, psychological, sociological, anthropological, legal, and economic perspectives. Assessments of ELSI are influenced on the one hand by cross-cultural differences and value-based perspectives, and on the other, have an impact on the way individuals and societies perceive ART, on the evolution of norms of clinical practices, and on the way these technologies are regulated, provided, and funded [8–13].
+
+As in many other fields, the bulk of global research is mainly produced by a limited number of countries, mostly from North America and Europe, Australia and Japan, and more recently by China and India ([14, 15]; White K., 2019). However, analyzing the geographic distribution of academic research based solely on funding sources and corresponding authors may raise some biased conclusions since it ignores many cases in which the country under research is different than that of the researcher or the funder.
+
+In this paper, we analyze international trends in the global literature concerning ELSI of ART between 1999 and 2019. We focus on the international research output in this field, which we define as those cases in which an academic article has a corresponding author from one country but is studying another. We previously reported on the whole corpus of literature that was extracted from PubMed, Web of Science, and Scopus and included 7714 articles concerning ELSI of ART, i.e., ART applications from humanities and social sciences perspectives (Alon et al., 2023 — under review in JARG). Nevertheless, 3741 (48.5%) articles were identified as dealing with a specific country (or countries), of which 1260 (33.7%) were characterized as international research. In the entire corpus, 26% of the articles had a corresponding author from the USA and 14% had a corresponding author from the UK, although the combined leaders’ share decreased from 51% in 1999 to 31% in 2019. Moreover, within international research, 22% had a corresponding author from the USA and 14% had a corresponding author from the UK. More broadly, 81% of the entire corpus had a corresponding author from the leading 15 countries (89% in 1999 and 73% in 2019) (Alon et al., 2023 — under review in JARG). Hence, the ELSI literature in ART reviewed in this paper, similarly to ELSI literature in general, is largely shaped by socio-cultural contexts, including economic, religious, and social norms, among other value-based factors, that significantly differ across various societies and circumstances [16, 17]. Since this literature is largely concentrated in a limited number of countries or centers ([7]; Alon et al., 2023 — under review in JARG), it may result in findings that are not globally representative or comprehensive. Hence, value-based perceptions from a few countries may shape the framing of and approach towards research questions and analysis worldwide, which may pose a challenge to be addressed.
+
+Geographical concentration of publications stems from unequal distribution of research funds and therefore of researchers around the world. Additionally, some of the world leaders in the practice of ART, such as China, Japan, and Russia, may be producing substantial literature on ELSI of ART in local journals in their languages, literature that large part of it is therefore not being captured by systematic reviews that cover English publications. Their actual contribution to this body of research, and hence the role they could play in the international academic debate, may be underestimated.
+
+Given the unequal distribution of research funds, international research provides a genuine opportunity to expand the geographical scope of research, and diversify cultural perspectives within the global discussion surrounding ART, which is particularly relevant for the value-based ELSI disciplines. International research may be perceived as potentially imposing the views of researchers from well-funded countries regarding, for example, what value ought to underline the field or what research questions are worth exploring. This could promote patronizing attitudes towards countries where research funds are limited, and cultural values differ from those in rich Western countries that dominate the field. However, international research can also encourage foreign researchers to familiarize themselves with local settings and become better embedded in local cultural contexts. It could also promote a richer research agenda by challenging local social values, asking novel questions from an external perspective, and offer diverse views and insights. Furthermore, what we describe here as international research often takes the form of research collaboration that involves co-authorship among researchers and institutions from different countries, at times including local researchers. Such international collaborations have become more common over the past decade, reflecting an expanding recognition of the significance of diverse perspectives in research [6].
+
+Our aim in this paper is to analyze research links between countries, by crossing the country/es of corresponding author/s with the country/es mentioned in the abstract, as an indicator of the research subject. Additionally, we analyze co-authorships involving different countries. To enrich the analysis, we identify shifts in research focus by dividing the corpus into ART fields and by using Topic Modeling (TM) with Latent Dirichlet Allocation (LDA). Our findings show gaps and opportunities for international research concerning ELSI of ART.
+
+Methods1
+
+Design
+
+We designed inclusion criteria to select articles dealing with ELSI of ART and exclusion criteria to exclude articles dealing entirely with clinical and medical matters, as described in Appendix A.
+
+Collection
+
+The corpus was collected from the online databases PubMed, Web of Science (WoS), and Scopus. Since we aimed to analyze titles, abstracts, and keywords, we included article that had an abstract in English, regardless of the article language.
+
+Following a keywords frequency analysis, three groups of Medical Subject Headings (MeSH)-terms were selected, as shown in Appendix B. Group A included ART terms and Group B included terms indicating a relation to ELSI across disciplines within humanities and social sciences. Group C was formed to exclude irrelevant articles. We aimed to find balance between false-positive (inclusion of articles with medical-clinical nature) and false-negative (exclusion of articles concerning social sciences and humanities). We used the PubMed API [18] to query for articles with “One MeSH-term from group A” AND “One MeSH-term from group B” AND “Humans (MeSH)” AND “1999-2019” NOT “Any MeSH-term from group C.”
+
+The PubMed query brought up 11,246 results of which 7003 had a full record of title and abstract in English. Additionally, 159 articles which were queried with no full record from PubMed were imported from Scopus. In total, 7162 articles had a full record.
+
+We dropped all abstracts with less than 50 words (259); removed articles if article type included “Clinical Trial,” “Controlled Clinical Trial,” “Randomized Controlled Trial,” or “Validation Study” (536); and excluded all journal related to biodiversity (34). 6333 articles remained, we extracted a list of keywords including their frequencies within titles and abstracts and divided them to three groups of keywords (see Appendix B) with similar definition as described above. We queried the WoS and Scopus APIs for articles of which the title, abstract, or keywords had “One term from group A” AND “One term from group B” AND “1999-2019” NOT “Any term from group C.”
+
+We extracted 14,394 and 12,588 articles from WoS and Scopus, respectively. In addition to the 6333 extracted from PubMed, 33,315 articles were merged from all three databases. Following the removal of duplicates of titles, abstract, and DOI, 17,247 articles remained, of which 14,283 had available title and abstract in English. We repeated the cleaning methods previously applied on the PubMed query (explained above), and removed 154 articles due to short abstract (less than 50 words), and 99 from journals of biodiversity. 14,030 articles remained.
+
+Manual Cleaning
+
+Two researchers cleaned up the corpus by analyzing the titles and abstracts with an emphasis on the rejection criteria from Appendix A. We removed 6315 articles and remained with a database of 7714 relevant articles of full record. 1184 were non-English articles, with English abstracts.
+
+Classification
+
+The abstracts were processed by merging the title and abstract into one string (“code”), harmonized, tokenized2, and lemmatized. We formed a list of terms to be replaced with acronyms or abbreviations in order to unify the text and allowing us to identify repetitions. Next, we extracted a list of terms by the frequency of “codes” in which they appear and divided the most frequent technical-medical terms into 10 ART fields (see Appendix C): (1) Egg Donation; (2) Sperm Donation; (3) Embryo Donation; (4) Surrogacy; (5) Fertility Preservation; (6) Stem-cell Research; (7) PGT; (8) Genome Editing; (9) MRT; (10) Assisted Insemination. An article was assigned into an ART field (or several) if one term, associated to that field, was found in its title, abstract, or keywords. The articles which included none of these terms were assigned by two researchers reading their titles and abstracts. The remaining articles (2267/7714) were appointed as “General.”
+
+Subsequently, for each publication, all obtainable metadata was extracted from WoS, Scopus, and PubMed, merged and unified under one template. Finally, we cleaned the abstracts from all those technical-medical terms that were used to define the 10 ART fields and then: (1) Uploaded the database to the VOSviewer software tool for constructing and visualizing bibliometric networks. (2) Applied Topic Modeling (TM) via Latent Dirichlet Allocation (LDA) (Blei, Ng, and Jordan 2003; Kapadia, 2019) to all “codes.” To do so, we have built a corpus dictionary using gensim3 open-source library.4 The LDA method assumes that the observed distribution of words in a textual corpus is determined by a statistical model that fixes both a word-topic and an article-topic association [7].
+
+We defined the number of topics by computing the coherence score as a function of the number of topics5 and by assessing the results in relation to the VOSviewer analysis. The results of the LDA algorithm consist in a list of topics, and in the weighted relations (0 to 1) between each article and each topic. Every topic is a list of characterizing words (reported in Appendix E), and each article may be connected to more than one single topic. Thus, as seen in Fig. 1, at least 5 topics should be identified. According to our analysis, we defined 6 topics (Fig. 4) as the most accurate solution: (1) Bioethics, (2) Cost and Outcome, (3) Law and Policy, (4) Psychology, (5) Family and Sociology, (6) Attitudes and Knowledge. Each article was associated with those topics by considering a weighted relation of more than 0.333334, so that each article could be associated with not more than two topics. As a result, only 161 articles remained unassociated.Fig. 1 Coherence score as a function of the number of topics
+
+Analysis
+
+In addition to the VOSViewer tool, we conducted an analysis based on the year of publication, countries of corresponding6 authors, and countries mentioned in codes as an indicator for the focus of the article. For the last, we searched the codes (abstracts, titles, and keywords) using a list of countries, cities (with no duplications), and nationalities.7 Furthermore, we analyzed the database according to the predefined ART fields, the topics identified by the TM, and regions8.
+
+We tested for Spearman’s correlations between the ART fields and the topics (Appendix 4). Those correlations were used for two purposes: first, to group ART fields in order to simplify the presentation of results, i.e., [Egg (C1) and Sperm donation (C2)], and [Stem-cell Research (C6) PGT (C7) and Genome Editing (C9)]; second, to verify a relationship between ART fields and topics.
+
+Results
+
+The total global research output in ELSI of ART grew from 72 publications in 1999 to 702 in 2019 (the gray area in Fig. 2). The share of publications that were dealing with a certain country (or several), which we label as “case-study,” was 39% in 1999–2005 and increased to 52% in 2013–2019 (the purple trendline). Among those “case-studies,” the share of “international case-studies” increased from 31% in 1999–2005 to 36% in 2013–2019 (the orange trendline). Therefore, the increase in the “international research” as a share of the total literature (the bottom yellow trendline) is mainly due to the increase in the share of “case-studies.”Fig. 2 Trendline of output and international research
+
+Areas of international research
+
+Figures 3 and 4 present the distributions of 10 ART fields and 6 topics, respectively, allowing to observe the differences in trends between the entire literature, case studies in general, and international research. Some articles were assigned to more than a single ART field or a single topic. For this reason, the total sums up to more than 100%.Fig. 3 Research by ART categories
+
+Fig. 4 Research by topics
+
+The field of “Egg & Sperm Donation” was increasingly elaborated under case studies in general. The field “Fertility Preservation” was researched in general terms more frequently than under a certain geographical context. Nevertheless, in the last 7 years, this field was more often engaged by international research. Along the timeline, “Surrogacy” became the central subject of international research while “Genetics,” which was highly engaged at the beginning of the period, moved out of the spotlight. These trends were evident for the entire corpus, but were particularly noticeable in international research.
+
+As seen in Fig. 4, the topic “Bioethics” had decreased prominence under case studies and under international research compared with the general literature. In contrast, “Law and Policy,” which was the growing and most central topic at the end of the period for the entire literature, was more intensely engaged by international research. Hence, a comparison of laws and regulations between countries has become one focus of the literature over time. International research of the other topics was more limited, mainly concerning “Psychology.” Nevertheless, due to the inclusion criteria for the database selection, this topic includes only articles with ELSI or impact on patients’ decision-making and not all psychological research concerning ART.
+
+Producers of international research
+
+Figure 5 shows the top 20 producers of international research. In the first few years under study, 5–15 countries were responsible for nearly all international research production. However, at the end of the period, the top 20 countries (Fig. 5) were responsible for the production of 83% of international case studies, while a few more emergent producers (Russia, Ukraine, Taiwan, Greece, and Romania) presented several publications (more than 5 each, in 2019). For the two leaders, the USA was ahead in publications throughout most of the period and kept stable while the UK lost a significant share.Fig. 5 20 top producers of international research
+
+Subjects of international research
+
+Figure 6 shows the top 23 countries that were international research subjects (were mentioned in at least 20 publications throughout the period). The UK was regularly the most popular subject for international research. Among some of the emergent research subjects, we notice India, which became the third most studied, China, the world leader of ART, Israel, Turkey, and Mexico.Fig. 6 23 top subjects of international research
+
+Pivot analysis
+
+Tables 1, 2, and 3 in Appendix E combine a pivot analysis of ART fields and topics in international research, allowing to identify some major trends and reveal which countries are conducting research about which countries, and in which ART fields and topics.Table 1 Matrix of regional international research
+
+The matrix shows the total number of international publications produced by each region with their share out of the total case studies produced by that region
+
+Table 2 Matrix of international research
+
+Table 3 Top 23 subjects of international research by ART fields and topics
+
+Table 1 in Appendix E presents the number of international publications produced by each region in relation to the region under study. It also presents the percentage of international publications as a share of all case studies produced by that region. The Northern American Region, which is constituted of only two countries, is the leader of international publications. A large share of it studied Western and Southern Asia, particularly India and Israel, but Northern American researchers were also engaged in research about Europe, Eastern and Southern Asia, and Latin America.
+
+The Northern and Western European Regions have increased their production of international research while the Southern European share declined over time. Moreover, Western European nations were increasingly producing research within their continent while Southern European nations produced their research even closer to home, mainly within their own region. In contrast, international research by Northern Europeans was gradually more diversified in geographical terms. Additionally, Latin American research increased over time and a large share of it was exchanged within the continent. Eastern European and African countries had increasing output and growing participation in international research.
+
+On a national level (Tables 2 and 3 in Appendix E), the exchange between the two leaders was the strongest among all nations. The US research about the UK was strongly centered on the field “Genetics” throughout most of the period, with a focus on the topics “Bioethics” and “Law and Policy.” In the opposite direction, the UK research on the USA was more diversified, with a light focus on similar topics and the addition of “Family and Sociology.” The UK and the USA, as research subjects, attracted many researchers from Australia, Canada, and European countries. In the first 7 years, such international research in the UK was extremely focused on “Genetics,” “Bioethics,” and “Law and Policy,” but later the field “Surrogacy” gained share. The research about the USA was more diversified.
+
+India was the next popular research subject, as 75% of the research mentioning it was done by a foreign corresponding author. It mainly addressed the topic “Law and Policy” and was strongly approached by researchers from the USA (21%) who were intensely focused on “Surrogacy.” In total, 112 articles addressed surrogacy in India, which is 12.6% of all articles dealing with (ELSI of) surrogacy, and 68% of those dealing with India.
+
+In South Europe, studies about France and Italy have been quite diverse with a growing interest in “Surrogacy” and a modest focus on “Egg & Sperm Donation.” Research about Spain has become much more focused on these two ART fields with an emphasis on the latter. Moreover, the research on this region was strongly engaged with “Law and Policy.” Except for the engagement by the two leaders, USA and UK, a large part of the international research in South Europe was actually exchanged within the region, although France was also often researched by Belgium under the field “Egg & Sperm Donation.”
+
+Research about Canada had a diminishing interest in “Egg & Sperm Donation” and an emerging interest in Surrogacy over the last 7 years, with a focus on the topics “Law and Policy” and “Cost and Outcome.” Germany was intensely researched by Switzerland (about “Fertility Preservation”) and Austria, while Australia was engaged mainly by researchers from the UK.
+
+Research about China and Brazil was extremely focused on “Genetics” and “Bioethics.” It became slightly more diversified with time, although more for Brazil than for China, where it remained the focus of 49% of international research in the final 7 years. Japan, the second largest operator of ART, was also a popular research subject under the field “Genetics” and the topic “Bioethics” between 1999 and 2012. However, in 2013–2019, the focus shifted towards “Fertility Preservation” under the topics “Law and Policy” and “Cost and Outcome.” China, Japan, and Brazil were mainly approached by researchers from the USA and UK.
+
+In Western and Southern Asia, Israel was the second most popular subject following India, under a diverse portfolio of ART fields and topics, as it was mainly approached by researchers from the USA. Together, India and Israel were the target of 75% of this region’s international research, as a subject. The most common research subjects in Latin America were Brazil and Mexico, which were studied by researchers from the USA and the UK, with a focus on MRT. Costa Rica and Chile were also studied by researchers from the Latin American region. In Eastern Europe, Turkey, the Czech Republic, Poland, Russia, and Ukraine were the subject of a few studies, with a focus on Surrogacy. Lastly, in the last few years, South Africa, Egypt, and Kenya, as subjects, attracted some international researchers to Africa, mainly from the USA.
+
+Co-authorship
+
+In addition, we used the VOSviewer tool to analyze co-authorships between countries.9 We invite the reader to consult the interactive version of this figure, available online at: https://app.vosviewer.com/?json=https://drive.google.com/uc?id=1YWviVOhhsOSh7VkeTj2JaPrZyyNgDZnR;
+
+In Fig. 7, we may identify four clusters: one led by Northern America which has strong research links with Brazil, China, and Israel; a second cluster led by the UK which is firmly linked with Northern and Southern Europe; third, a cluster for Western Europe, and finally, a cluster led by Australia which is linked with India, Japan, and Africa. Contrary to our previous analysis, the co-authorship between countries does not explicitly reveal anything about the countries being research subjects, but only might imply that such collaborations enable and even stimulate international research. It is therefore not an unambiguous indicator for international research. Nevertheless, it allows an interesting glimpse into international collaborations in ART research.Fig. 7 Co-authorship between countries
+
+Discussion
+
+Between 1999 and 2019, research output on ELSI of ART increased nearly tenfold (Fig. 2), indicating a much higher growth rate compared with clinical research in ART and with the global scientific output [5–7]. In this paper, we explored international research by considering the country of the corresponding author and the country mentioned in the abstract. We noted an absolute increase in the number of international studies, as well as an increase in their relative portion of the whole literature, which rose from 12% in 1999–2005 to 19% in 2013–2019. It is largely explained by an increase in the share of articles representing case studies, i.e., discussing specific countries. Thus, 33% of all case studies in the corpus and 36% of the case studies in the last 7 years (2013–2019) involved a corresponding author from one country studying a different one, which shows that international research about the ELSI of ART is widespread. Nevertheless, as we have shown, large part of this research was exchanged between the core countries and within the leading regions.
+
+According to the US National Center for Science and Engineering Statistics, international co-authorships in global sciences increased from 17 to 23% between 2008 and 2018 [6]. An analysis of co-publications showed a continuous increase in international collaborations between 2000 and 2015. It concluded that the globalization of science is an on-going process that is changing the power dynamics underlying the scientific enterprise and reshaping the global scientific landscape. More countries are participating, ties between countries are becoming more frequent, and international collaboration once led by Europe and the USA is gradually replaced by a tri-polar world comprising Europe, North America, and the Asia-Pacific region [15].
+
+A previous analysis of ELSI research in personalized genomic medicine from 2008 to 2012 revealed that, of 135 ELSI articles in English, 90 (66.7%) focused on ELSI issues outside the USA [19]. Only a limited number of articles discussed Asian and African countries. In contrast, the ELSI of ART corpus from 1999 to 2019, collected in this paper, represents a more decentralized literature. A total of 85.2% of the articles examined ELSI issues outside the USA, with about 25% discussing Asian countries and less than 3% discussing African countries. It is important to note that 15.4% of the corpus is non-English. More countries were producing international research and positive trends of decentralization are apparent, in relation to the countries of corresponding author and the countries under study (Figs. 5 and 7) as well as the countries that are the subject of such research (Fig. 6). It is too early to state that the European-American hegemony has been dismantled. Despite the relatively high share of international research and the rise of India as a research subject, as well as a growing interest in China, we saw that a large share of international studies involved the leaders (USA and UK) and Northern, Western, and Southern European countries.
+
+In Europe, we may identify a link between research funding and international research (Table 1 in Appendix E). The richest region, Northern Europe, was more geographically diversified in its research, and Western European research was conducted mainly within the continent, while the Southern European nations with the least academic resources conducted more international research within their own region. This allows interesting insight into the relationship between funding and research topics. The more resources one has, the more one can “afford” to study regions and countries that are different than one’s own. Hence, increasing research funding and capacity may help diversify research topics and fields globally and allow research attention to be dedicated to areas that are currently understudied.
+
+Research collaborations
+
+We identify a few international trends in the literature that are compatible with global trends [15]. To some extent, geographic distance is important as neighboring countries often collaborate with each other. However, peripheral countries, in terms of scientific output, are more likely to collaborate with the core nations instead of favoring partnerships with other nearby peripheral countries. Thus, on the one hand, we notice some pairs of frequently collaborating neighbors such as the USA and Canada, France and Belgium, France and Spain, Germany and Switzerland, Germany and Austria, Australia and New Zealand, and Denmark and Sweden.
+
+On the other hand, “peripheral countries” such as India, China, Japan, Brazil, Turkey, and Mexico were mainly studied by and collaborated with researchers from the core nations (see Fig. 7 and Table 2 in Appendix E). Hence, there were strong and growing research links between North America (mainly the USA), and North Europe as research producers, and Western-Southern Asia (mainly India and Israel), as research subjects. This was also seen between Western and Northern Europe as research producers and Easter Europe as a research subject.
+
+In the last 7 years of study, 2013–2019, there was also an increase in the production of international research within Eastern and Southeastern Asia and within Latin America (Table 1 in Appendix E). In those years, in 18 cases, researchers from Japan, Taiwan, China, and Singapore conducted international research about China, Vietnam, Japan, Thailand, Singapore, and South Korea. In Latin America, 13 international articles had corresponding authors mainly from Brazil and were focused on Costa Rica, Chile, and Argentina.
+
+This landscape suggests that it remains important to encourage researchers to explore understudied regions and address topics that are highly dependent on cultural contexts. Ethical, social, and legal issues are often framed and addressed in ways that are deeply embedded within local cultural assumptions. International research that explores the ELSI of ART in diverse cultural contexts therefore has particular potential to shed light on the reasons for differences and discrepancies across the world. It can also point to ways to overcome such discrepancies in areas where harmonization and standardization of policy and of clinical norms can enhance the protection which are vulnerable parties involved in ART (such as children conceived via ART, surrogates, and egg donors).
+
+Trends in international research areas
+
+Several trends emerged in relation to the fields explored by international research. First, “Egg & Sperm Donation” was highly and increasingly studied through case studies, i.e., in a national context, both concerning research that was produced by authors from the country under study or by another (Fig. 3). The share of international research dealing with this field increased over time, for China and Japan and all European countries (which appeared in Table 2 in Appendix E), except for Sweden and the Netherlands. It was particularly high for Spain and Denmark.
+
+Considering the aging of populations and delayed childbearing in Europe and East Asia, as well as the global crisis in terms of male infertility [20], it is easily understandable why egg, sperm, and embryo donations are a popular subject for a case studies. A very large share of ART cycles, particularly in Europe, involve third-party reproduction, with Spain dominating the market for donor eggs and Denmark that of donor sperm. At the same time, regulations and clinical norms in this context vary substantially, for example, the rising interest in Italy was possibly affected by the 2014 rule of the Italian Constitutional Court which overturned the ban on gamete donation [21]. Moreover, these practices raise multiple socio-ethical tensions involving all stakeholders: ART users, donors, children conceived, and society at large. These tensions often touch on key issues such as the definition of parenthood, parental right and responsibilities, or the rights of children to know their genetic origins. It is hence clear why these issues attract the attention of ELSI scholars.
+
+Second, the engagement of international research with “Surrogacy” has grown remarkably throughout the study period. In the last 7 years, a third of all international research output explored this field (Fig. 3). Specifically, 31% of international publications on surrogacy focused on India, with 5% on Thailand. This increased interest in surrogacy could be partially attributed to the ethical tensions and inequalities based on class, race, and nationality, surrounding the use of surrogates from low-income countries by couples from high-income countries [22], especially when access to surrogacy is limited in the commissioning couple’s country of origins. Furthermore, international research on surrogacy also concentrated on the USA, France, Netherlands, Canada, Spain, Italy, and Austria. The bans on surrogacy in the last three countries may have prompted discussions on this matter, potentially explaining the research focus on these nations.
+
+Surrogacy indeed raises inherent and deep socio-ethical and legal issues, such as the definition of motherhood or the potential exploitation of vulnerable women. It thus deserves the attention of ELSI scholarship. As Pande notes: “A global and complex issue like surrogacy cannot be resolved or regulated within national borders. A global issue like surrogacy needs a global dialogue” [23]. At the same time, since surrogacy represents an extremely low share of ART cycles, this level of engagement may seem rather disproportional, especially in light of gaps in research on issues that are inherent to every aspect of ART, such as cost and access. While we are fully aware of the importance of addressing local issues that are ethically fraught and threaten human rights, considering limited research resources, we cautiously call attention to this focus on a practice that is overall clinically marginal, at the expense of others that have implications for millions of ART users, such as research on attitudes towards and knowledge about infertility and ART.
+
+Third, we demonstrated a notable decrease in the proportion of research addressing the field of “Genetics,” particularly prominent between 1999 and 2005 for the entire corpus, and even more so across international research (Fig. 3). From 2006 onward, the focus on “Genetics” gradually diminished, becoming more domestically focused with fewer case studies and less international research. An exception lies in the growing study of ELSI surrounding MRT, particularly regarding the UK, as it was the first country to regulate this practice [24]. Mexico has also attracted attention due to the 2016 controversy surrounding the birth of the world first MRT-conceived baby [25].
+
+The declining focus on “Genetics” is a surprising, considering the technological advancements during this period, including improvements in stem cell and regenerative medicine, the increased addition of PGT (mainly PGT-A) to ART [1], and the developments in germline genome editing using CRISPR [26]. Several hypotheses can be proposed for this decline. The period between 1999 and 2005 was influenced by various factors generating heightened interest in genetics, such as the cloning of the first mammal — Dolly the sheep — in 1998, the establishment of the ELSI program at the NIH [27], the completion of the human genome project in 2003, and the growing acceptance of PGT as a supplementary technique for ART. The decline after 2005 could be attributed to the normalization of certain technologies, the establishment of regulatory frameworks, and the integration of ELSI perspectives into broader discussions, consequently leading to a shift in research focus.
+
+Another potential explanation is that ELSI researchers have become more cognizant of common concerns already addressed by the literature, such as consent, risk-benefit analysis, informed decision-making, and data sharing. As a result, they may have avoided duplicating publications where existing ethical principles and guidelines were readily applied to new technologies. Furthermore, the increasing domestic focus could be linked to an emphasis on local policies, cultural frameworks, and socio-economic challenges reflecting the needs that emerge when technologies are being implemented into the clinical context.
+
+Indeed, this decline in “Genetics” is only relative, and in absolute terms, the number of articles did increase over the last two decades. Still, we would have expected a steeper growth even compared with other fields. In this context, it is important to mention that in such areas of emerging biotechnologies, some key publications are not academic peer-reviewed papers captured by our analysis, but rather gray literature including influential reports written by leading groups, institutions, or associations [28–30] due to urgency of needs for policy guidance.
+
+In terms of topics, the decrease in “Bioethics” could be explained by the decrease in the field “Genetics,” as the two are correlated — much of the funding of bioethics came from the ELSI program of the NIH [27] and similar funding programs in Europe, which all focus on genetics. Additionally, we examined the effect of excluding articles co-tagged with “Genetics” and discovered that the decrease in “Bioethics” is even more strongly associated with “Genetics” in the context of case studies and international research. Consequently, we propose that there is potential for further research in the field of “Genetics” under different topics, especially “Cost and Outcome,” and “Attitudes and Knowledge” in relation to service accessibility, cost-effectiveness, financial burden, and public education. For instance, in the case of PGT, it would be worthwhile to investigate, under varying healthcare systems, the number of families and individuals who are unable to access this technology, and to examine the implications of this limited access for health outcomes, equity, and societal well-being.
+
+Our analysis shows first a strong increase in the engagement of international research with the topics “Cost and Outcome” from 10% in 1999–2005 to 16% in 2006–2012 and then a decline to 13% in 2013–2019. As seen in Fig. 4, during the period under study, the topic “Cost and Outcome” was engaged more domestically than through international research. Concerning “Attitudes and Knowledge,” there is a noticeable contrast between its rising share in the entire corpus, which increased from 12% in 1999–2005 to 21% in 201–2019, and its decreasing share in international studies, where it dropped from 15 to 12% (Fig. 4). These topics are of paramount importance, and while the overall increase in interest in “Attitudes and knowledge” is encouraging, the decline in international research is problematic. This decline may generate gaps that can negatively impact ART users, clinicians, and policy makers. Addressing “Attitudes and Knowledge,” a topic that represents research on people’s knowledge of and attitudes towards infertility and ART, is critically important under an international context. This includes comparative analysis, as infertility rate upsurge worldwide due to factors such as reproductive age, life style, and pollutants [31, 32]. ELSI research ought to address the global and international aspects of these issues, in particular public education about the causes, implications, and social impact of infertility and the use of ART. Such issues are embedded in cultural values and attitudes, as well as social norms, and thus necessitate the methodologies and conceptual analysis that ELSI of ART research can bring to the field.
+
+Concerning “Cost and Outcome,” it is important to note that this topic may be less explored by international research due to the inherently local nature of costs and the significant variations in policies regarding public funding of ART across countries. Additionally, the overall economic circumstances of each country impact both the availability of public funding and the ability to pay for ART out of pocket. As a result, while international comparisons can be interesting, their value might be limited unless local circumstances are carefully considered and controlled for. Nonetheless, in many countries, ART is mostly or at least partly a private service paid for out of pocket. A large share of the population struggles to fund and access it [33–36]. These research directions could be particularly interesting in the USA and China and in less wealthy nations that offer only modest or no public funding of ART. These issues affect the great majority and have immediate implications for decision-makers in every country. We therefore argue that this gap in the literature dealing with access to treatment, as well as the burden of ART funding on households, is problematic and should be addressed by redirecting research attention to these challenges.
+
+Overall, our analysis revealed that the ELSI of ART literature exhibits a preference for areas of study that represent conceptual challenges and attract philosophical analysis, often involving thought experiments and discussions of hard or extreme cases. There is also a predilection for areas that permit access to relatively straightforward empirical research. However, the literature seems less inclined to address systemic justice issues that necessitate economic analysis and engagement with challenges of barriers to access.
+
+We believe that while conceptual analysis and thought experiments hold value and are interesting, an excessive focus on these aspects can be problematic. This is particularly concerning when it consumes most of the intellectual and research resources in the field, leaving less room for studies that explore practical issues such as cost and associated analyses of justice and equity of access, or studies addressing knowledge and attitudes, and their potential impact on infertility prevention or the use and misuse of ART. We argue that a more balanced approach to ELSI of ART research is needed, incorporating both philosophical discussions and the exploration of practical concerns that directly affect the lives of those dealing with infertility and ART.
+
+Study limitations and future research directions
+
+Our analysis is not exempt from some methodological limitations. First, our selection and cleaning process necessarily contains a certain level of subjectivity. The selection criteria were complex and included terms selected by the authors. Many articles were removed by “manually” analyzing their abstracts and both false-positives and false-negatives are possible. In particular, we made an effort to avoid amassing a large number of medical-technical articles (false-positive) by excluding certain terms (both MeSH-terms and keywords) from our queries. The exclusion might have led to fewer articles appearing under the “Cost and Outcome” topic (false-negative), which could explain the low share of articles associated with this topic. Second, in the classification process, the ART fields were defined according to keywords’ selection, while the occurrence of one term in the abstract indicated an affiliation to an ART field. This could lead to some mistakes. Third, a country was defined as the research subject based on its being mentioned in the abstract (including names of cities). We made a great effort to manually identify and correct mistakes resulting from this methodology. However, we assume that few errors could have remained unnoticed.
+
+Finally, topic modeling by LDA has some limitations [37]. The algorithm assumes a certain probabilistic distribution behind the word/article association, which may not hold in reality. Moreover, there is no “standard” or objective way of fixing the number of topics, which remains a free parameter, adjusted in accordance with different metrics. Consequently, due to the number of topics one eventually selects, some smaller topics may remain hidden. Despite these limitations, our findings are based on a comprehensive corpus collected from three major databases, a relatively strong LDA, and an additional method of categorization.
+
+In terms of future research, we may further exploit the collected database by dividing it into ART fields and topics which enable various systematic literature reviews and meta-analyses by extracting a single ART field (or topic) and presenting its distributions of study designs, key issues, research questions, and outcomes, according to geographic location and timeline. Furthermore, building upon our findings, future research could investigate the factors contributing to the shifts in research focus across various fields and topics that we have demonstrated, as well as explore some of the hypotheses we have raised. By examining the underlying reasons for these shifts, their relationships with ELSI research trends, and potential policy implications, scholars can deepen the understanding of the dynamics within the broader context of assisted reproduction. Finally, future studies can explore whether local issues (that emerge from local policies or socio-economic contexts) are sometimes consequently studied in other countries or regions.
+
+Conclusion
+
+This paper analyzed the body of academic literature exploring international research on ELSI of ART emphasizing the importance of diversifying cultural perspectives and enriching the global discussion on the topic. Our findings demonstrate that international research can offer valuable insights and identify gaps and opportunities that would otherwise remain unnoticed. We noted a geographic centralization in terms of research production, reflecting an unequal distribution of research fund across countries and regions. Given the potential of international research to challenge local social values, ask novel questions, and foster international collaborations, we conclude that it is important to encourage researchers from wealthy academic centers to collaborate with researchers from regions with fewer resources, and to focus on less explored regions.
+
+Some of the largest research gaps we identified concern China and Japan, the two world leaders in ART cycles, and Russia, another major ART user. Their unique cultural contexts yield particular restrictions on some types of ART, which in turn produce unique conditions for cross-border reproductive care. This highlights the importance of international research in examining the impact of cultural differences on ART practices and regulations. While the observed gap can be partially explained based on language and place of publication (we only considered publications with abstracts in English and there may be substantial scholarship on the ELSI of ART published in local journals), it remains important to increase the research attention given to these countries and their cultures, considering their leadership in clinical use.
+
+We advocate for a more balanced approach in ELSI of ART research, incorporating both philosophical discussions and the exploration of practical concerns that directly affect the lives of patients, couples, and individuals requiring ART services. International research plays a crucial role in addressing the diverse needs and challenges faced by different populations, particularly in the context of cost, access, and the economic burden created by ART. Yet, these topics remain underexplored compared with topics that only touch on a portion of ART cycles (such as sperm and egg donation, surrogacy, or PGT for sex selection) and to which the literature dedicates much attention. We therefore offer a call to the ELSI of ART research community to divert more attention to questions of cost and access, while emphasizing the value of international research in uncovering unique issues and fostering diverse perspectives.
+
+The same is true for issues of knowledge about and attitudes towards infertility and ART, which are exceptionally important yet understudied. International research in this area can provide valuable insights into the global variations in attitudes and knowledge. Future research could explore the level of interest this body of literature has in providing policy recommendations and guidance, across regions and topics. Much of the empirical and the conceptual research on ELSI of ART has strong normative implications. It would thus be interesting to explore whether researchers take the extra step and turn these implications into normative recommendations that can inform and improve policy, in order to provide better protections to all stakeholders in the ART space, but especially to vulnerable parties.
+
+Appendix A. Inclusion and exclusion criteria for articles in the review
+
+Inclusion criteria	Exclusion criteria	
+All articles concerning all sorts of ART and Assisted Insemination (AI) which are dealing either:
+
+• Fully or partially with demographic research (national or regional activity reports and registries, geographical and socio-economic patterns of usage), ELSI, economic, regulations, anthropological, and political issues. OR
+
+• with value-based approaches, attitudes, opinions, expectations, and preferences. OR
+
+• with education, knowledge, and empowerment of decision-making among patients and donors. OR
+
+• with psychology and quality of life issues, raising ELSI or affecting government policy making and patients’ decision-making.
+
+	Articles which focus on either:
+
+• Clinical methods/outcome or technical issues with no relation to ELSI or social sciences. OR
+
+• Physicians’ professional approaches, opinions, preferences, education, and knowledge concerning clinical decision-making of technical character. OR
+
+• Psychology/quality of life outcomes by way of empirical research with no ELSI or impact on patients’ decision-making.
+
+	
+Rejection criteria: Articles dealing exclusively with (1) Animal research; (2) Treatment outcome, unless measured in terms of population and socio-economic characteristics (i.e., national registries); (3) Clinical policies on a local level (in contrast to national/regional policies); (4) Clinical outcome and performance of technologies and protocols; (5) Processes within hospitals and clinics; (6) Prenatal testing and selection; (7) Therapeutics (non-ART) uses of stem cell research; (8) Clinical trials or reports in psychiatry/psychology with no ELSI or impact on patients’ decision-making.	
+
+Appendix B. MeSH-terms and keywords
+
+Group A — Inclusion of ART terms	MeSH-terms (for PubMed) (28)	
+Reproductive Techniques, Assisted • Donor Conception • Embryo Transfer • Single Embryo Transfer • Fertility Preservation • Fertilization in Vitro • Mitochondrial Replacement Therapy • Sperm Injections, Intracytoplasmic • Gamete Intrafallopian Transfer • Insemination, Artificial • Insemination, Artificial, Heterologous • Insemination, Artificial, Homologous • Oocyte Donation • Oocyte Retrieval • Posthumous Conception • Embryo Disposition • Sperm Banks • Surrogate Mothers • Preimplantation Diagnosis • Sex Preselection • Gene Editing • Genome Editing • Genetic Enhancement • Adult Germline Stem Cells • Germ Cells • Ovum • Oocytes • Embryo Research • Research Embryo Creation	
+Keywords (for WoS and Scopus) (38)	
+assisted reprod* • assisted procreat* • reproductive techn* • in vitro fertili* • intracytoplasmic sperm injection • In vitro gametogenesis • egg don* • oocyte don* • sperm don* • embryo don* • donor eggs • donor conception • fertility preservation • oocyte cryopreserv* • egg freez* • sperm cryopreserv* • embryo cryopreserv* • oncofertility • leftover embryos • surplus embryos • frozen embryos • preimplantation genetic • reproductive genetic* • germline engineering • germline gene editing • germline gene modification • germline genetic modification • mitochondrial replacement • mitochondrial don* • surrogacy • surrogate mother • gestational carrier • uterus transplantation • artificial insemination • donor insemination • posthumous insemination • posthumous conception • posthumous reproduct*	
+Group B — Inclusion of terms from disciplines of humanities and social sciences	MeSH-terms (for PubMed) (23)	
+Disability Evaluation • Anthropology • Demography • Economics • Forecasting • Policy • Private Sector • Public Sector • Sociology • Work-Life Balance • Education • Stakeholder Participation • History • Knowledge • Philosophy • Religion • Disabled Persons • Vulnerable Populations • Population Characteristics • Health Care Economics and Organizations • Health Services Administration • Health Care Quality, Access, and Evaluation • Attitude	
+Keywords (for WoS and Scopus) (28)	
+*ethic* • *access* • anonym* • attitude* • perception • *consent* • market* • crossborder • disclos* • eugen* • *identity • justi* • educat* • law* • legis* • legal* • moral* • inmoral • policy* • politic* • govern* • sex select* • touris* • view* • autonom* • desire* • vulnerab* • relatedness	
+Group C — Exclusion of medical-technical terms	MeSH-terms (for PubMed) (45)	
+Ovulation Induction • Neoplasms • Pregnancy Complications • Follicle Stimulating Hormone • Breast Neoplasms • Odds Ratio • Sperm Motility • Prognosis • Semen Analysis • Congenital Abnormalities • Gonadotropin-Releasing Hormone • Ovarian Hyperstimulation Syndrome • Polycystic Ovary Syndrome • Pedigree • Recombinant Proteins • Clomiphene • Zygote • Mice • Reproducibility of Results • Ovarian Follicle • Chorionic Gonadotropin • Sperm Retrieval • Ovarian Neoplasms • Testis • Gonadotropins • Estradiol • Randomized Controlled Trials as Topic • Oligospermia • In Vitro Oocyte Maturation Techniques • Superovulation • Zygote Intrafallopian Transfer • Polar Bodies • Zona Pellucida • Sperm Head • Acrosome • Sperm Tail • Spermatids • Spermatocytes • Spermatogonia • Embryonic Germ Cells • Plants • Case-Control Studies • Botany • Agriculture • Clinical Trials as Topic	
+Keywords (for WoS and Scopus) (38)	
+ovulation Induction • neoplasms • follicle stimulating hormone • odds ratio • sperm motility • semen analysis • congenital abnormalities • gonadotropin • ovarian hyperstimulation • polycystic ovary • pedigree • recombinant proteins • clomiphene • zygote • ovarian follicle • testis • estradiol • randomized controlled trials • controlled trials • clinical trials • controlled clinical trial • validation study • polar bodies • zona pellucida • sperm head • acrosome • sperm tail • spermatids • spermatocytes • spermatogonia • embryonic germ cells • plants • case control • botany • agriculture • oligospermia • oocyte maturation • superovulation	
+*Zero or more characters
+
+Appendix C. Words and terms for division into ART fields
+
+Axis A	
+Egg Donation	biobanking of eggs and embryo • buying and selling gametes embryos • child donor • donated egg • donated gamete • donated oocyte • donating eggs • donor art • donor child • donor conceived offspring • donor conception • donor egg • donor gamet • donor of gamet • donor of sperm or egg • donor offspring • donor oocyte • donor registry • donor sibling • egg bank • egg don • egg shar • eggdonation • gamete bank • gamete don • gametes don • gametes sale • half sibling • oocyte bank • oocyte don • oocytes don	
+Sperm Donation	buying and selling gametes embryos • child donor • donate his sperm • donated gamete • donated sperm • donating sperm • donation of gamete • donor art • donor child • donor conceived offspring • donor conception • donor father • donor gamet • donor insemination • donor of gamet • donor of sperm or egg • donor offspring • donor semen • donor sibling • donorconceived child • gamete bank
+
+gamete don • gametes don • gametes sale • half siblings • known donors • semen bank • semen donor • single mother • sperm bank • sperm don • sperm from a known donor • spermdon
+
+	
+Embryo Donation	14 day limit • s biobanking of eggs and embryo • s buying and selling gametes embryos • s donated eggs and embryo • s donated embryo • s donation embryo
+
+embryo adoption • s embryo don • s embryodon • s embryos in excess • s excess embryo • s frozen embryo • s surplus embryo
+
+	
+Surrogacy	commissioning parent • intended parent • shared gestation • subrog • surrog	
+Fertility Preservation	fp_ • cryopreserv • egg freez • embryo disposition • embryo freez • embryo storage • fertility preserv • fertilitypreserv • freezing egg • freezing oocyte • freezing ovari • frozen egg • frozen embryo • frozen sperm • not implanted embryo • oncofertility • oocyte preserv • ovarian tissue • post mortem • posthumous • postmortem • social freezing	
+Stem Cells	artificialgametes • embryo destructive research • embryo research • embryo scientific research • experimentation on embryos • gamete product • human embryo • oocytes for research • pluripotent • research on embryo • stem cell •
+
+totipot
+
+	
+Preimplantation Genetic Testing	_pgd_ • _pgs_ • _pgt_ • embryo select • enhancement • gender select • genetic counsel • genetic select • genetically select • hla matched • hla typing • pre implantation diagnos • pre implantatory exam • preimplantation diag • preimplantation or prenatal screening • preimplantational • preimplantatory • procreative benef • reproductive genetic • saviour sibling • selection of embryo •
+
+sex select • whole genome sequencing
+
+	
+Genome Editing and Cloning	_ggm_ • chimer • clone • cloning • crispr • designer baby • enhancement • gametogene • gene edit • genetic eng • genetic manipul • genetic modific • geneticeng • germ line • germline • nuclear transfer • posthuman • procreative benef • synthetic gamet	
+Mitochondrial Replacement Techniques	_mrt_ • mitochondrial disorder • mitochondrial gene trans • mitochondrial transfer • ooplasmic transfer • spindle transfer • three parent • tri parent	
+Assisted Insemination	_iui_ • insemination	
+*2267 articles were not assigned to any ART field and were labeled General (Gen)
+
+Appendix D. Spearman’s correlations between ART fields and topics
+
+	Correlation coefficient	
+Egg Donation (S1) – Sperm Donation (S2)	0.521	
+Egg Donation (S1) – Family and Sociology (T5)	0.202	
+Sperm Donation (S2) – Assisted Insemination (S10)	0.337	
+Sperm Donation (S2) - Family and Sociology (T5)	0.341	
+Embryo Donation (S3) – Fertility Preservation (S5)	0.238	
+Surrogacy (S4) – Law and Religion(T4)	0.264	
+Fertility Preservation (S5) – Cost and Outcome (T2)	0.264	
+Fertility Preservation (S5) – Attitudes and Knowledge (T6)	0.264	
+Stem Cells (S6) – Genome Editing (S8)	0.233	
+Stem Cells (S6) – Bioethics (T1)	0.343	
+PGT (S7) – Genome Editing (S8)	0.213	
+PGT (S7) – Bioethics (T1)	0.265	
+Genome Editing (S8) – Bioethics (T1)	0.413	
+Assisted Insemination (S10) – Family and Sociology (T5)	0.216	
+*For all pairs, p-value (2-tailed) =0.000
+
+Appendix E. Topic modeling output
+
+Topic 1 — Bioethics (green): (‘0.027*“ethical” + 0.015*“genetic” + 0.014*“moral” + 0.008*“medical” + “0.008*“legal” + 0.008*“ethic” + 0.007*“scientific” + 0.005*“principle” + “0.005*“development” + 0.005*“medicine”’).
+
+Topic 2 — Cost and Outcome (bottom red): (‘0.040*“patient” + 0.019*“transfer” + 0.018*“rate” + 0.013*“cycle” + “0.009*“clinical” + 0.009*“procedure” + 0.008*“risk” + 0.008*“clinic” + “0.008*“cost” + 0.008*“ethical”’).
+
+Topic 3 — Law and Policy (blue): (‘0.024*“law” + 0.019*“legal” + 0.011*“country” + 0.010*“social” + “0.009*“policy” + 0.008*“regulation” + 0.006*“legislation” + 0.006*“medical” “+ 0.006*“work” + 0.006*“analysis”’).
+
+Topic 4 — Psychology (yellow): (‘0.029*“couple” + 0.015*“psychological” + 0.015*“infertile” + “0.010*“counselling” + 0.010*“factor” + 0.009*“patient” + “0.009*“participant” + 0.008*“social” + 0.008*“relationship” + “0.008*“interview”’).
+
+Topic 5 — Family and Sociology (purple): (‘0.092*“child” + 0.049*“parent” + 0.041*“family” + 0.022*“couple” + “0.018*“mother” + 0.013*“lesbian” + 0.013*“conceive” + 0.012*“genetic” + “0.012*“sex” + 0.011*“relationship”’).
+
+Topic 6 — Attitudes and Knowledge (top red) (‘0.028*“patient” + 0.020*“age” + 0.013*“couple” + 0.013*“risk” + “0.013*“attitude” + 0.012*“knowledge” + 0.009*“medical” + 0.008*“genetic” + “0.007*“young” + 0.007*“participant”’).
+
+Funding
+
+Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. This work received financial support provided by both the Margarita Salas Fellowship from the Autonomous University of Madrid and the Centre de recherche en éthique (CRÉ) at the University of Montreal which have both provided invaluable financial assistance, enabling us to conduct our research.
+
+Declarations
+
+This research did not involve human participants or animals and did not require any informed consent of any type.
+
+Competing interests
+
+The authors declare no competing interests.
+
+1 Please note that a fully detailed description of the methods used in this study can be found in “Mapping Ethical, Legal, & Social Implications (ELSI) of Assisted Reproductive Technologies” (under review in JARG).
+
+2 To low-rise and tokenize we used: https://tedboy.github.io/nlps/generated/generated/gensim.utils.simple_preprocess.html
+
+3 “gensim.corpora.Dictionary”
+
+4 I.e., transforming words/sentences into vectors (with 1 and 0): word: id mapping to apply TM afterwards. GENSIM topic modelling for humans. https://radimrehurek.com/gensim/corpora/dictionary.html
+
+5 https://radimrehurek.com/gensim/models/coherencemodel.html for TM using gensim.models.LdaMulticore with the following parameters: gensim.models.LdaMulticore(corpus=corpus, id2word=id2word, num_topics=k, random_state=100, chunksize=100, passes=10, per_word_topics=True), k number of topics ranging from 2 to 15.
+
+6 Information about author affiliation (with country of institution) was retrieved from the databases.
+
+7 For example, “Portug” to capture Portugal and Portuguese, “Spain” and “Spani,” “Poland” and “Polish.” Also, cities’ names with double meaning (i.e., Male, Huntington) were carefully removed.
+
+8 According to the United Nations Geoscheme: https://unstats.un.org/unsd/methodology/m49/ (some regions were merged due to proximity and low number of publications, i.e., Latin Americas and the Caribbean, Western and Southern Asia, Eastern Europe and Central Asia, Eastern and South-eastern Asia).
+
+9 Minimum articles per country = 21, min cluster size =7 (Argentina, Iran and Malaysia were removed)
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
+1. CDC Assisted Reproductive Technology - National Summary Report 2018 2020 Atlanta, US Centers for Disease Control and Prevention, American Society for Reproductive Medicine
+2. ESHRE Trends over 15 years in ART in Europe: an analysis of 6 million cycles Hum Reprod Open 2017 2017 2 hox012 10.1093/hropen/hox012 31486803 PMC6276702
+3. Ishihara O Jwa S Kuwahara A Assisted reproductive technology in Japan: A summary report for 2018 by the Ethics Committee of the Japan Society of Obstetrics and Gynecology Reprod Med Biol 2021 20 3 12 10.1002/rmb2.12358 33488278 PMC7812461
+4. ESHRE ART in Europe, 2017: results generated from European registreis by ESHRE Hum Reprod Open 2021 2021 3 hoab02 10.1093/hropen/hoab026 PMC8342033 34377841
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Digit Health
+Journal ID: Front Digit Health
+NLM Journal ID: 101771889
+Journal ID: Front. Digit. Health
+
+Frontiers in Digital Health
+
+EISSN: 2673-253X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13473991
+PMID: 42602252
+DOI: 10.3389/fdgth.2026.1936568
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Association between clinical characteristics within 6 h of ICU admission and 30-day mortality risk in immunocompromised sepsis patients: development and validation of a machine learning model based on the MIMIC-IV database
+
+Cheng Zhipeng † Conceptualization Data curation Formal analysis Validation Writing – original draft Writing – review & editing
+Ma Xiuqing † Resources Software Visualization Writing – review & editing
+Duan Weiying Data curation Investigation Methodology Writing – review & editing
+Mou Zeyu Data curation Validation Visualization Writing – review & editing
+Liang Zhixin * Conceptualization Funding acquisition Investigation Methodology Supervision Writing – review & editing
+Department of Respiratory and Critical Care Medicine, First Medical Center, Chinese PLA General Hospital , Beijing , China
+* Correspondence: Zhixin Liang liangzhixin301@163.com† These authors share first authorship
+
+Electronic publication date: 2026 Jul 31
+Publication date: 2026
+Volume: 8
+Electronic Location ID: 1936568
+Received 2026 Jul 13; Accepted 2026 Jul 21
+Copyright: © 2026 Cheng, Ma, Duan, Mou and Liang.
+Copyright year: 2026
+Copyright holder: Cheng, Ma, Duan, Mou and Liang
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Association between clinical characteristics within 6 h of ICU admission and 30-day mortality risk in immunocompromised sepsis patients: development and validation of a machine learning model based on the MIMIC-IV database 8 13 7 2026 1881138 Frontiers in Digital Health 10.3389/fdgth.2026.1881138 PMC13402528 42516412
+Keywords: eICU-CRD, immunosuppression, MIMIC-IV, mortality risk, prediction model, sepsis, support vector machine
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Health Informatics
+
+Ÿ==============================Ÿ
+There was a mistake in Figure 5 as published. Due to an upload error during the production stage, the feature labels and ordering in Figure 5B were incorrect. The corrected Figure 5 appears below.
+
+Figure 5
+
+In the published article, there was a mistake in the text on page 5, where “PTT” was erroneously written instead of “PLT”.
+
+A correction has been made to the Results section, paragraph 1:
+
+“Weight, APS_III, SAPS_II, GCS, Charlson comorbidity index, RBC, MCH, MCV, MCHC, Cr, BUN, PT, PLT, INR, AST, and Urine output. Significant differences (P <0.05) were also found in the prevalence of comorbidities such as hypertension, heart disease, liver disease, kidney disease, and lung disease, as well as in the use of vasoactive drugs, invasive ventilation, continuous renal replacement therapy, and renal replacement therapy”.
+
+The original version of this article has been updated.
+
+Generative AI statement
+
+Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Edited and Reviewed by: Selene Tomassini, University of Trento, Italy
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Public Health
+Journal ID: Front Public Health
+NLM Journal ID: 101616579
+Journal ID: Front. Public Health
+
+Frontiers in Public Health
+
+EISSN: 2296-2565
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12960585
+PMID: 41799453
+DOI: 10.3389/fpubh.2026.1765145
+Article version: 1
+Article version:
+Subjects: Systematic Review
+
+Barriers to accessing healthcare for people with disabilities:a systematic review
+
+Chimienti M. 1 2 † Writing – review & editing Writing – original draft
+Morlino G. 1 2 † Writing – original draft Writing – review & editing
+Ndreca D. 1 * Investigation Writing – original draft Funding acquisition Software Resources Conceptualization Supervision Visualization Project administration Writing – review & editing Validation Data curation Methodology Formal analysis
+Stefanidhi K. 1 * Software Conceptualization Visualization Funding acquisition Writing – review & editing Writing – original draft Resources Investigation Formal analysis Validation Project administration Data curation Supervision Methodology
+Zerellari O. 1 Writing – review & editing Writing – original draft
+Shkreli R. 1 Writing – review & editing Writing – original draft
+Gjergji S. 1 Writing – review & editing
+Leonforte F. 3 Writing – review & editing
+Nicosia V. 4 Writing – review & editing
+Mistretta A. 4 Writing – review & editing
+Buonomo E. 1 Writing – review & editing
+Liotta G. 2 Writing – original draft Writing – review & editing
+Palombi L. 1 Writing – original draft Writing – review & editing
+1 Catholic University Our Lady of Good Counsel , Tirana , Albania
+2 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome , Italy
+3 Department of Integrated Hygiene, Organizational and Service Activities (Structural Department), Health Management, University Hospital Polyclinic “G. Rodolico-San Marco” , Catania , Italy
+4 Department of Medical and Surgical Sciences and Advanced Technologies “G.F Ingrassia”, University of Catania , Catania , Italy
+* Correspondence: K.Stefanidhi, kristinastefanidhi@gmail.com; D.Ndreca, daniela.ndreca2@gmail.com† These authors have contributed equally to this work
+
+Electronic publication date: 2026 Feb 19
+Publication date: 2026
+Volume: 14
+Electronic Location ID: 1765145
+Received 2025 Dec 10; Revised 2026 Jan 30; Accepted 2026 Jan 30
+Copyright: Copyright © 2026 Chimienti, Morlino, Ndreca, Stefanidhi, Zerellari, Shkreli, Gjergji, Leonforte, Nicosia, Mistretta, Buonomo, Liotta and Palombi.
+Copyright year: 2026
+Copyright holder: Chimienti, Morlino, Ndreca, Stefanidhi, Zerellari, Shkreli, Gjergji, Leonforte, Nicosia, Mistretta, Buonomo, Liotta and Palombi
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: access, barriers, disability, health services, inequalities, quality of Life
+
+Funding: The author(s) declared that financial support was not received for this work and/or its publication.
+
+Figure count: 4
+Table count: 2
+Equation count: 0
+Reference count: 116
+Page count: 13
+
+section-at-acceptance: Public Health Policy
+
+Ÿ==============================Ÿ
+Objective
+
+This review identifies global evidence on barriers to healthcare access for disabled persons and healthcare service efficiency. It highlights recurring patterns, systemic discrimination, and evidence gaps. The review supports policy development, health system redesign, and future research to advance disability-inclusive health equity.
+
+Methods
+
+Strict inclusion and exclusion criteria were applied. The investigation used PubMed, Scopus, and Web of Science with rigorous double-blind screening and analysis.
+
+Results
+
+Of 6,570 articles, 86 studies were selected (28 mental/cognitive/developmental, 33 physical, 25 multiple disabilities) including diverse adult age groups. Barriers included physical, financial, transportation, communication, attitudinal, organizational, knowledge-related, sensory, cultural, and systemic hurdles.
+
+Critical gaps include disproportionate focus on barriers rather than interventions (only 10%), implicit facilitators, underrepresentation of stakeholder perspectives, and geographic concentration in high-income countries.
+
+Conclusions
+
+Significant barriers hinder service access. Most frequent were financial constraints, transportation challenges, communication difficulties, limited physical accessibility, provider knowledge gaps, and socio-cultural stigma. Accessibility is typically addressed through individualized accommodations rather than systematic universal design. Providers frequently lack training and hold negative attitudes; technology retrofits rather than design inclusively. Effective solutions require systemic redesign and placing disability at the center of health equity efforts.
+
+Introduction
+
+Individuals with disabilities are defined as those who possess physical, mental, intellectual, or sensory impairments that, due to interaction with various barriers, hinder their full participation in society (1). The concept of disability has evolved from a solely illness-based, corrective medical approach to a more integrated view, recognizing disability as the result of personal, environmental, and social factors (2). They represent approximately 15% of the global population affecting more than 1 billion people (3). In 2019, one in every eight people, or 970 million people around the world were living with a mental disorder (4). Specifically, physical disability rates are often reported as around 1.4% in high-income countries and can be higher in low- and middle-income countries (5). These disparities contribute to avoidable suffering, reduced quality of life, and preventable premature mortality, making healthcare accessibility a public health priority.
+
+An essential right and a critical aspect to a person's well being is access to healthcare and social-health services. This analysis demonstrates that while everyone should enjoy access to healthcare adapted to their needs without discrimination, this goal remains unmet in many parts of the world (6). Some researchers have identified numerous barriers including financial and economic, physical access and transportation, provider knowledge and training barriers and system organization and coordination barriers. Financial barriers, such as limited insurance coverage, cost of specialized services or socioeconomic disparities are one of the invisible walls patients encounter in their journey. Physical barriers, including transportation challenges, lack of trained staff, inaccessible healthcare facilities but also inaccessible housing near healthcare providers are considered to be major structural obstacles. Additionally, lack of accessible communication and digital accessibility issues have a huge impact on their quality of life discouraging them from seeking care.
+
+While numerous studies have documented challenges to healthcare access, the evidence remains fragmented across disability types and health systems, context-specific, and descriptive. Much of the research focuses on individual-level barriers without integrating them into a broader view. Furthermore, limited research evaluates the effectiveness of interventions and also the perspectives of people with disabilities leaving a critical gap in knowledge about how healthcare systems can be redesigned to achieve disability-inclusive equity. Recent reviews confirm disabled individuals face barriers including transportation difficulties, physical inaccessibility, and provider knowledge gaps, with rural populations experiencing 13–40% higher unmet needs, while legal frameworks remain insufficient without multi-sector collaborative partnerships (7, 8).
+
+This systematic review aims to identify, map and synthesize global evidence on barriers to healthcare access for people with disabilities and how effective is the access to healthcare and social- health services. Specifically, it seeks to identify recurring patterns, highlight systemic and structural dimensions of discrimination, and reveal areas where evidence remains limited. By doing so, this review provides a foundation for policy development, health system redesign, and future research to advance disability-inclusive health equity.
+
+Materials and methods
+
+Eligibility criteria
+
+The PECO(S) framework was used for this systematic review; the criteria used are shown in Table 1.
+
+Table 1 PECO(S) Framework.
+
+PECOS	Inclusion criteria	Exclusion criteria	
+(P)opulation	- People with various disabilities (physical, sensory, mental, cognitive, and developmental, communicative)“.
+- >18 years old	- People without disabilities
+- < 18 years	
+(E)xposition	- Social and health care needs for access to medical treatment	- Studies not analyzing interventions, care models and service approaches	
+(C)omparator	- People without disabilities (where available).
+- >18 years old		
+(O)utcome	- Identification of barriers, the degree of access to services, and their impact on life (comorbidity, mortality, and morbidity)	- Studies that do not value barriers to access to healthcare and social care for people with disabilities and their impact on quality of life	
+(S)tudy design	- Case reports;
+- Case series;
+- Cross sectional studies;
+- Cohort studies;
+- Case control studies;
+- Qualitative studies;
+- Quasi experimental studies;
+- RCT (randomized clinical trials);
+- Mixed methods studies	- Book chapter;
+- Editorial;
+- Commentary;
+- Letter to the editor;
+- Review	
+Other criteria	- Studies published after 2014;
+- Included both quantitative and qualitative data	- Not written in English;
+- Full text not available;
+- Studies published before 2014	
+
+Research methods
+
+The systematic review was conducted in accordance with the international PRISMA (9) guidelines, with the aim of mapping the available evidence on barriers to accessing healthcare and social care services for people with disabilities. Based on the research questions, three search strings were developed to identify relevant studies in the following electronic databases: PubMed, Scopus, and Web of Science.
+
+Specific search strings combining terms related to access to care were adapted for each database in order to optimize information retrieval.
+
+The search identified studies on healthcare access barriers and facilitators for adults with disabilities from 2014 onwards. The 2014 cutoff captures post-CRPD implementation evidence and contemporary healthcare systems while ensuring sufficient evidence volume. The search combined three concept groups: disability terms (disability, impairment, physical, sensory, mental, cognitive, and developmental, communicative disability), healthcare access terms (access, barriers, facilitators, utilization), and outcomes (quality of life, equity, disparities). Database-specific controlled vocabulary (MeSH- Medical Subject Headings- for PubMed) was combined with free-text keywords to maximize sensitivity while maintaining specificity.
+
+Below are the strings for PubMed, Scopus, and Web of Science, respectively (Table 2).
+
+Table 2 Search strings.
+
+•PubMed	
+(“access to healthcare” OR “barriers” OR “challenges” OR “disparities” OR “inequalities” OR “limitations”) AND (‘disability' OR “people with disabilities” OR “physical impairment” OR “mental disabilities” OR “chronic diseases” OR “cognitive disabilities” OR “developmental disabilities”) AND (“health services” OR “medical care” OR “treatment” OR “support services” OR “rehabilitation services” OR “primary care” OR “social services” OR “telemedicine” OR “community health care”) AND (“quality of life” OR “health impact” OR “patient outcomes” OR “morbidity” OR “mortality” OR “comorbidity”)	
+•Scopus	
+(“access to healthcare” OR “access to healthcare” OR “barriers” OR “challenges” OR “disparities” OR “inequalities” OR ‘limitations') AND (“disabil*” OR “handicap” OR “impairment” OR “functional limitations”) AND (“health care” OR “health services” OR “medical care”) AND (“quality of life” OR “health outcomes” OR “well-being” OR ‘morbidity' OR “mortality”)	
+•Web of science	
+TS=(“access to healthcare” OR “access to healthcare” OR “barriers” OR “challenges” OR “disparities” OR ‘inequalities' OR ‘limitations') AND (“disabil*” OR “handicap” OR “impairment” OR “functional limitations”) AND (“health care” OR “health services” OR “medical care”) AND (“quality of life” OR “health outcomes” OR “well-being” OR ‘morbidity' OR “mortality”)	
+
+Study selection and data extraction
+
+Two independent reviewers selected the studies in two stages: titles and abstract screening to assess relevance, followed by full-text review of the articles selected in the first stage to verify eligibility based on the inclusion and exclusion criteria. Any disagreements were resolved through discussion.
+
+Relevant data were extracted from the included studies using a predefined grid, to extract information on: study characteristics (author, year, country, study design, objectives, sample size, type of care, type of health service, data collection methods, data analysis methods), participant characteristics (type of disability, age, gender, experiences of individuals with disabilities and their caregivers), barriers and facilitators to access, and relevant outcomes.
+
+The data extraction grid was developed iteratively by the research team. Categories were selected based on: PRISMA standards and the PECO(S) framework; disability-specific barriers identified in preliminary scoping searches (financial, transportation, communication, provider knowledge); and stakeholder perspectives.
+
+Caregiver experiences were included as a distinct category because caregivers often serve as healthcare navigators and advocates for people with disabilities, and their burden directly impacts care access. The grid was pilot-tested on five diverse articles (varying by disability type and study design), refined through team discussion, and finalized by consensus.
+
+Evaluation of study quality
+
+The evaluation of study quality was conducted using a variety of scales, using multiple validated appraisal tools, selected based on established best practices for systematic reviews incorporating diverse study designs. Three distinct checklists were utilized in the course of the study, with the CASP (Critical Appraisal Skills Programme) checklist (10) was used for the majority of studies, including cross-sectional, cohort, and qualitative studies, as well as RCTs, because it provides design-specific checklists with clear quality criteria applicable across these methodologies. The JBI (Joanna Briggs Institute) (11) checklist was utilized for case report studies due to its specialized criteria for evaluating case-based evidence, while the MMAT (Mixed Methods Appraisal Tool) (12) was employed for mixed methods studies as it is specifically designed to assess both qualitative and quantitative components within a single study, which cannot be adequately evaluated using single-method tools. This approach follows recommendations for systematic reviews including heterogeneous evidence, where different study designs require tailored quality assessment criteria to avoid inappropriate application of quality standards across incompatible methodologies.
+
+Two reviewers assessed each study independently, resolving any discrepancies through discussion or consultation with a senior reviewer. Scores were converted into percentages to facilitate quality assessment.
+
+Results
+
+The systematic analysis of the literature led to the identification of 6,570 articles: 2,740 from PubMed, 1,347 from Scopus, and 2,483 from Web of Science.
+
+After excluding 1,978 duplicates, the remaining documents were selected based on their titles and abstracts. Of the 529 articles included, a full-text reading excluded 443 articles, 43 of which were excluded because they were not in English or Italian, and 400 because they did not meet the Criteria. Finally, our selection led to the identification of a total of 86 documents included in the review. The article selection process is shown in the flow chart (Figure 1).
+
+Figure 1 Flowchart diagram.
+
+PRISMA flow diagram illustrating the review process: out of 6,570 records identified, 1,978 duplicates were removed, 4,592 records screened, 3,982 excluded, 610 reports sought, 81 not retrieved, 529 assessed for eligibility, and 443 excluded (400 not meeting criteria, 43 not in Italian or English), resulting in 86 studies included.
+
+Risk of bias
+
+In assessing the risk of bias in qualitative, RCT, observational and mixed-method articles, scales appropriate to the type of study were used, accepting only two error notes to define the article as high quality: as can be seen in Figure 2, the number of articles with a low risk of bias is 59, the number of articles with a medium risk of bias is 24 and the number of articles with a high risk of bias is three. The summary tables of the bias risk assessment of the selected articles are presented in the Supplementary material (S4-S9).
+
+Figure 2 Overall judgement of risk of bias evaluation of selected articles.
+
+Bar chart illustrating the overall judgment for the quality of selected studies with three categories: high risk of bias (3 studies, yellow), medium risk of bias (24 studies, blue), and low risk of bias (59 studies, green).
+
+Quality assessment informed interpretation but not inclusion decisions. All eligible studies were retained to maximize evidence mapping across diverse contexts and populations. During synthesis, the research team considered the quality of supporting evidence when drawing conclusions, with awareness that the majority of findings were derived from low risk-of-bias studies, providing confidence in the robustness of identified patterns.
+
+Data extraction of selected studies
+
+The complete extraction tables can be found in the Supplementary Tables S1, S2.
+
+Narrative synthesis
+
+Study characteristics
+
+A total of 86 articles were included in this review. Geographically, 30 studies were conducted in North America (United States and Canada), 18 in Europe (UK, Germany, Ireland, Poland), 13 in Asia (Afghanistan, China, South Korea, India, Lao PDR, Saudi Arabia, Iran, Nepal, Philippines), 12 in Africa (South Africa, Ghana, Ethiopia, Uganda, Malawi, Nigeria, Sub-Saharan Africa), 9 in Oceania (Australia and New Zealand), and one in South America (Brazil). The most represented countries were the United States with 25 articles (13–37), UK with 13 articles (38–50), Australia with 7 (51–57), South Africa with 5 (58–62) and Canada with 5 (63–67). In addition, three studies were classified as international (68–70).
+
+The publication years ranged from 2014 to 2025.
+
+Regarding the methodological approach, 52 studies employed quantitative methods, 29 utilized qualitative methods, and five used mixed-methods.
+
+Among quantitative studies, the most common study design was cross sectional including 36 articles (14, 15, 17–21, 24, 25, 28–34, 38, 46, 51, 53, 58, 61, 68, 70–82), followed by 15 Cohort studies (22, 35, 36, 39, 43, 45, 56, 57, 62–64, 69, 83–85) and 1 RCT (randomized clinical trial) (16). Data for these studies were primarily collected via surveys or analysis of administrative records.
+
+The qualitative studies include (13, 23, 26, 27, 37, 40–42, 48–50, 52, 54, 59, 65–67, 86–96) and 1 case report study (44) largely adopted descriptive or phenomenology designs, primarily using semi-structured interviews and focus groups for data collection.
+
+Finally, the 5 mixed-methods studies (47, 55, 60, 97, 98) combined surveys with in-depth interviews.
+
+By disability category, 33 studies focused on physical disabilities (21–27, 30, 32, 33, 35, 37, 48–50, 55, 56, 58, 59, 61, 62, 66, 69, 70, 76–78, 89–91, 93, 94, 96), 28 on mental, cognitive, and developmental disabilities category (13–18, 38–46, 51, 53, 54, 57, 63, 67, 71–73, 86, 87, 97, 98), including psychiatric conditions (e.g., schizophrenia, depression), cognitive impairments (e.g., dementia), and developmental disabilities (e.g., autism, intellectual disabilities), and 25 addressed multiple disabilities (19, 20, 28, 29, 31, 34, 36, 47, 52, 60, 64, 65, 68, 74, 75, 79–85, 88, 92, 95).
+
+The majority of studies examined general adult populations (≥18 years), with a trend toward middle-aged adults. Gender representation was reported in 75 studies as mixed, seven were unspecified, six focused exclusively on females, and 1 on males. Sample sizes ranged widely from 1 participant (44) to 35,773,286 (15).
+
+Regarding healthcare system classification, 48 studies were conducted in universal systems, 36 in mixed systems, one in private systems, and one did not specify.
+
+Across the studies, the types of care examined ranged from multidisciplinary in 25 articles (14, 20, 24, 30, 32–35, 42, 47, 52, 55, 56, 60, 65, 70, 75–77, 80, 82, 86, 89, 97, 98) to primary healthcare services in 19 articles (15, 16, 18–21, 29, 37–39, 41, 46, 51, 63, 67, 73, 88, 92, 95), rehabilitation services, general healthcare, hospital care, specialist services, preventive care and community-based services.
+
+Data collection methods varied, with surveys being the most common, followed by interviews, administrative data and medical records, secondary data analysis, literature reviews, and mixed approaches.
+
+The main objectives across the studies were diverse, including the identification of barriers and challenges to healthcare access, the examination of healthcare disparities and inequalities, the assessment of disease prevalence and health outcomes, the evaluation of healthcare service delivery and models, the exploration of patient and provider experiences, and the analysis of rehabilitation and therapy services. Additional objectives focused on interventions and programs, access to healthcare in general, the role of digital health and technology, as well as preventive care and screening, alongside other mixed aims.
+
+Regarding outcomes, an analysis of our studies reveals ~30% analyzed disease burden outcomes related to more chronic conditions occurring simultaneously, higher mortality rates and more severe morbidity when conditions do occur (14, 15, 17, 21, 22, 29, 32, 43–45, 53, 56, 58, 61–63, 71, 74, 83–85, 89, 98).
+
+Barriers to accessing the healthcare system
+
+Commonly reported barriers included financial and economic constraints (15, 19, 20, 25, 26, 32, 34, 58, 61, 65, 66, 70, 74, 80–82, 89–92, 95), physical access and transportation difficulties (19, 24–26, 30, 33, 48, 52, 54, 59–61, 74, 75, 79, 88–90, 92, 95), followed by inadequate provider knowledge and training, and system-level issues related to organization and coordination as shown on Figure 3. Reported facilitators of access included system-level reforms, technology integration, person-centered approaches, and family or caregiver support.
+
+Figure 3 Mapping of barriers to access in selected articles.
+
+Horizontal bar chart showing main barrier groups to healthcare access by percentage: economic barriers at sixty-seven percent, accessibility barriers at twenty-one percent, healthcare system barriers at twenty percent, communication and information at nineteen percent, social and attitudinal at sixteen percent, and individual or patient-level at seven percent.
+
+Barriers and facilitators were analyzed across three primary categories of disability. A significant proportion of the articles identified multiple barriers.
+
+In the context of mental, cognitive, and developmental disabilities, the most prevalent type is communication and cognitive barriers, which is represented in 89% of the studies (13–15, 17, 18, 38–46, 51, 53, 54, 57, 63, 67, 71, 73, 86, 97, 98). This is followed by healthcare provider knowledge and training gaps, which is represented in 75% (13, 14, 17, 18, 38, 39, 41–46, 51, 53, 54, 57, 63, 67, 71, 73, 86, 87, 97, 98) of the studies, system & service coordination barriers in 68% (14, 16, 17, 39, 41–45, 53, 54, 57, 63, 67, 71, 73, 87, 97, 98) and financial & economic barriers in 54% (13–17, 40, 51, 54, 57, 63, 72, 73, 87, 97, 98). In a smaller percentage are diagnostic & screening barriers in 43% and sensory & environmental barriers in 36% of the studies. The percentages indicate the share of studies that reported barriers within each category.
+
+In the context of research pertaining to multiple disabilities, 96% of studies noted the presence of financial and economic barriers (19, 20, 28, 29, 31, 34, 47, 52, 60, 64, 65, 68, 74, 75, 79–85, 88, 92, 95), 68% identified issues related to inaccessible transportation, long travel distances, rural residence, lack of paved roads, remote locations (19, 20, 28, 29, 31, 52, 60, 64, 65, 74, 75, 79, 80, 85, 88, 92, 95) and 64% reported barriers related to physical accessibility and infrastructure (19, 20, 28, 29, 60, 64, 65, 75, 79, 80, 82, 83, 85, 88, 92, 95).
+
+In the context of physical disability, economic and financial barriers emerged as the most prevalent barriers (25, 26, 30, 32, 33, 35, 37, 48, 50, 55, 56, 59, 61, 66, 69, 70, 76–78, 89–91, 94, 96), accounting for 82% of cases. This was followed by transportation difficulties in 64% (24–26, 30, 32, 33, 48, 59, 61, 69, 70, 76–78, 89–91, 93, 96) and healthcare provider and system issues (60%) (22, 23, 26, 37, 48–50, 55, 56, 58, 59, 69, 70, 77, 89–91, 94, 96).
+
+Lived experiences varied across contexts. Many individuals reported difficulties accessing healthcare services, barriers to quality care, mental health and psychological consequences, physical and environmental challenges, communication and information gaps, stigma and discrimination, economic barriers, employment and independence concerns, and challenges in managing specific medical conditions. Ten studies did not report on lived experiences (22, 25, 29, 31, 35, 39, 42, 67, 81, 84).
+
+Caregiver perspectives on the other hand were largely absent, but in those reported the most common experiences were physical and daily care burden, financial and economic impact, system coordination and management, communication and information challenges, social and family relationships, healthcare navigation and advocacy, emotional and psychological impact, training and education needs, transportation and access barriers and professional work impact.
+
+Facilitators of access to the healthcare system
+
+We extracted all factors that authors identified as associated with improved healthcare access, which we collectively term “facilitators”. Our approach to data extraction was inclusive and this broad extraction strategy allowed us to capture the full spectrum of evidence, from observed correlations or existing structural features correlated with better access (e.g., insurance coverage, higher income, care coordination structures, provider awareness etc.) to evaluated interventions, purposefully designed programs tested with measured outcomes, including health screening programs, telehealth services, home modification programs, training initiatives. Figure 4 illustrates the distribution of facilitator types identified across the reviewed studies.
+
+Figure 4 Percentages of access facilitators in selected articles.
+
+Horizontal bar chart illustrating percentages of main facilitator groups in selected studies: healthcare system factors highest at approximately thirty-five point five percent, followed by financial and socioeconomic at twenty point one percent, and person-centered care at sixteen point six percent; remaining categories range from eight percent down to five point two percent.
+
+When synthesizing findings across all reviewed studies, the most prevalent facilitator was healthcare system factors (14, 15, 17, 63, 64, 83, 84, 87), followed by financial & socioeconomic factors (21, 36, 58, 68, 71, 75, 76) and care coordination/integrated services (39, 42, 52, 59, 67, 76, 87, 98), with smaller contributions from person centered care and social support (8.04%), technology (6.47%), workforce training (6.12%), and physical accessibility (5.24%).
+
+In the context of mental, cognitive, and developmental disabilities, the most prevalent facilitators are as follows: modifications to how healthcare services are structured and provided were reported in 82% of the articles (13, 16–18, 38–46, 51, 53, 54, 57, 67, 73, 86, 87, 97, 98). In 54% of the studies, it is mentioned collaboration between different services and providers (14, 16, 39, 41–45, 53, 54, 57, 67, 73, 87, 98) while in 50% adapted materials and communication methods (13, 16, 38, 40–46, 51, 54, 67, 86) are a source of facilitators.
+
+A review of the literature reveals that financial and insurance support for multiple disabilities is a recurring theme in 76% of articles (19, 20, 29, 31, 34, 36, 64, 68, 75, 79, 81–85, 88, 92, 95), with service delivery models in 60% of articles (29, 31, 47, 60, 65, 75, 88, 92, 95) and person-centered care and support (52%) also being prominent topics (19, 20, 29, 36, 47, 52, 64, 74, 75, 79, 82, 88, 95).
+
+The majority of the physical disability studies reported on identified socioeconomic facilitators (22, 58, 76, 78), followed by the role of social and family support (21, 30, 55, 89–91, 93), and healthcare system infrastructure(25, 37, 56, 59, 77).
+
+Gaps in literature
+
+The reviewed studies reveal several gaps in the evidence base. In the studies reviewed, researchers inferred facilitators from context as they were not explicitly delineated by the original study authors (13, 14, 17, 18, 36, 43, 45–47, 52, 54, 57, 63, 74, 75, 87, 88), and in fives articles there were no facilitators reported (28, 61, 69, 72, 80). The majority of studies document barriers while most identified facilitators represent observed associations or existing structural features rather than tested interventions. Even though we extracted all factors that authors identified as associated with improved healthcare access under a collective term, analyzed data revealed that 10% of reviewed studies represented evaluated interventions (13, 16, 18, 40–42, 57, 59, 60, 67). The lived experiences of people with disabilities were missing in 10 studies (22, 25, 29, 31, 35, 39, 42, 67, 81, 84) and reported from context in 16 studies (13, 14, 19, 20, 36, 43–47, 54, 57, 63, 75, 87, 88). Caregiver perspectives, on the other hand, were largely absent from the reviewed literature, 58 out of 86 studies did not report caregivers' perspective (15–18, 20–25, 27–36, 38–40, 42, 43, 49, 51, 53, 55, 56, 58, 60–62, 64–72, 74, 76–86, 93, 95, 96). Geographic representation was concentrated in high-income countries, with limited representation from low- and middle-income countries.
+
+Discussion
+
+The results of this systematic review highlight a complex and multifaceted landscape of health inequities faced by people with disabilities, varying not only by type of impairment but also by context, health system structure, and cultural environment. Systemic and structural barriers were identified in approximately 40% of the reviewed studies, representing a substantial focus within the analyzed literature. The reviewed studies documented healthcare systems characterized by fragmentation requiring extensive coordination, while professional training gaps emerge as critical obstacles identifying poor disability awareness and staff discomfort (41, 42, 52, 54, 67). These findings align with international evidence documenting similar barriers in healthcare access for people with disabilities across diverse country contexts (99–101). Geographic disparities, such as the 64–84-min travel time reported in studied literature for rural populations (75), may reinforce how access appears to be influenced more by geographic location than by medical need alone. However, the geographic concentration of studies in high-income countries creates a generalizability crisis and equity paradox. High-income countries typically have better baseline access, meaning evidence comes from contexts with fewer barriers, while low- and middle-income countries, where disability-related healthcare access barriers are typically more severe and resources more limited remain under-researched (68–70).These findings also align with international studies (7, 8).
+
+Closely related are the disparities in healthcare utilization and access (~27%), identified in our review, which reveal a paradoxical pattern of both overuse and underuse of services. Emergency department overuse is consistent (55, 63) while critical underutilization persists with less than 33% of Parkinson's patients receiving appropriate rehabilitation referrals and 87% of hearing problems remaining untreated (25, 102). The global variation in unmet healthcare needs, ranging from 7% in Switzerland to 62% in Morocco, documented in our reviewed studies, suggests disparities may reflect system-level factors rather than disability-inherent characteristics (70). Analyzing physical disabilities, it is seen that despite decades of disability rights legislation, physical infrastructure continues to present significant barriers. Studies included in our review show this harms body and mind, and reveals how inaccessible environments create physical and emotional distress and disempower negotiations (48, 49, 76).
+
+Communication barriers represent fundamental obstacles consistently documented across diverse disability populations and healthcare settings in our systematic review but also in other studies (13, 21, 25–28, 41, 42, 46, 51, 55, 67, 71, 73, 86, 94, 97, 103–106). These barriers range from basic communication difficulties associated with significant odds ratios, to more complex challenges in symptom reporting among individuals with autism, intellectual disabilities, and sensory disabilities. Technology-mediated communication shows promise, yet the majority of patients remain unaware of available services or unable to access them. These barriers affect not only care delivery but also navigation abilities and meaningful treatment participation. These findings from our systematic review are consistent with broader evidence on poor healthcare service ratings and provider communication challenges experienced by disabled patients (107, 108).
+
+Our review identified that financial barriers creating a vicious cycle with higher cost while having fewer resources leading to medical bill problems and rationing behaviors (15, 24, 66, 69, 75). On the other hand, our reviewed evidence indicates that insurance disparities are systematic, with commercial coverage providing superior outcomes while dual-eligibles experience worst outcomes (35). These barriers create cascading effects where delayed care leads to more expensive emergency interventions, creating downward spirals of health and economic vulnerability. This is further supported by studies included, demonstrating that financial barriers are associated with increased social costs. These costs are mainly attributable to individuals who require medical care and to the decreased productivity of those affected and their families (86).
+
+Health Outcomes and Mortality Disparities also referred as the Ultimate Consequence represent the life-threatening consequence of access barriers documented in our included studies. The reviewed studies documented elevated mortality risks across multiple conditions: higher COVID-19 mortality, cancer disparities including four times higher testicular cancer mortality, and maternal mortality that is 2.3 times higher in women with intellectual and developmental disabilities (17, 44, 45). These findings suggest avoidable suffering, premature death, and preventable secondary disabilities may result from cumulative barriers to care. Differences in treatment and care quality further underscore inequity. This pattern observed in our review is further supported by other studies that document reduced treatment intensity, diagnostic delays, poor care coordination creating fragmented experiences, and deviations from standard protocols, often without clear justification (44, 84, 98, 109, 110), indicating not just access problems but quality concerns when care is accessed. Similarly, technology and digital access present a dual reality: on one hand, digital exclusion further marginalizes those without access to devices or internet; on the other, telehealth, tele rehabilitation, and electronic records have demonstrated strong potential to improve outcomes, reduce emergency visits, and maintain high engagement when inclusive design principles are followed. The reviewed evidence aligns with international evidence suggesting that technology can either widen or narrow disparities depending on its implementation (111–113).
+
+Another significant obstacle that hinders the process of seeking treatment is stigma, described in included studies but also other literature as the fear of being judged by others, but also cultural attitudes, family barriers, and social determinants (40, 53, 72, 73, 114, 115). All these aspects lead to the prevention of certain behaviors (72). Other studies have also shown that these perceptions lead young people to avoid seeking mental health services, thereby delaying intervention and worsening clinical symptoms (116). Similarly, provider and professional factors highlight persistent training gaps, negative attitudes, and resource limitations. The shortage of disability-trained professionals demonstrates how inadequate workforce capacity directly constrains access.
+
+Our research has highlighted a worrying reality in which many identified “facilitators” represent basic accessibility features that should be standard practice such as longer appointments, clear communication, provider awareness (41, 42, 44, 46, 67, 86) rather than enhanced supports. This pattern observed across our reviewed studies suggests that standard healthcare practices may not adequately account for diverse patient needs. The fact that in a number of our studies facilitators were derived from context (13, 14, 17, 18, 36, 43, 45–47, 52, 54, 57, 63, 74, 75, 87, 88) or are missing (28, 61, 69, 72, 80) may reveal a conceptual weakness in how the research approaches enablers of access and studies aren't designed to identify what helps, only what hinders.
+
+Analysis of the included literature revealed that 58 out of 86 studies excluded caregiver perspectives entirely, despite caregivers' critical roles in healthcare access for people with disabilities. Among the 28 studies that included caregiver data, most focused on burden and challenges rather than their insights about effective access strategies or solutions (47, 52, 75, 88, 90, 91, 98). This exclusion in our interpretation represents a significant methodological blind spot. Caregivers often control appointment scheduling, provide transportation, navigate complex systems, and advocate for appropriate care, making their perspectives essential for understanding the full landscape of access barriers and potential facilitators. The absence of their voices means we may be missing major barriers (from a navigator's perspective) and practical solutions that emerge from their lived experience of system navigation.
+
+The reviewed evidence indicates that financial coverage and socio-economic privileges frequently determine access, suggesting the healthcare system may prioritize those with existing advantages rather than compensating for barriers (36, 58, 71). Several studies included, documented that accessing appropriate care often required multiple favorable circumstances converging adequate income, knowledgeable providers, family support, and appropriate technology (13, 52, 67), simply to access what ought to be universal rights. Studies found that healthcare system expansion does not automatically benefit people with disabilities, especially those with multiple disabilities who require integrated services, and may worsen disparities without explicit disability-focused interventions (52, 64, 75, 82). We interpret these findings as indicating that many so-called “facilitators” represent workarounds for systemic gaps rather than genuine enhancements to accessible care. While universal design principles offer critical system-wide improvements, the heterogeneity of disability experiences means that individualized, person-centered accommodations remain essential even within structurally inclusive frameworks, universal design provides the foundation, but cannot eliminate the need for tailored supports.
+
+Finally, and most concerning, intervention and solution effectiveness was the least studied domain. Our analysis reveals an important distinction: most identified “facilitators” represent observed associations or existing structural features rather than tested interventions. Yet these few studies demonstrated encouraging results: home modifications reduced hospitalizations, screening programs exceeded national benchmarks, device loan programs facilitated participation, and community-based services provided viable alternatives to inaccessible hospitals (13, 16, 18, 40–42, 57, 59, 60, 67). These findings underscore the urgent need for a research and policy shift from describing barriers to scaling solutions, improving disability awareness and professional training, facilitating earlier diagnosis, and reducing disparities in treatment. The current evidence base as we interpret it can identify what might help based on associations, but cannot confirm what works through experimental testing. This severe imbalance suggests the field is stuck in a 'diagnostic' phase, we know what's wrong and what's associated with better outcomes, but have limited experimental evidence on what interventions effectively improve access.
+
+Limitations
+
+In addition to the literature gaps already discussed, our study has specific methodological limitations. Our search was limited to English and Italian-language publication, which excludes potentially relevant research published in other languages. The 2014 publication cutoff, while ensuring contemporary relevance, may have excluded earlier foundational research. We restricted inclusion to adults aged 18 years and older, excluding pediatric populations and the critical transition from pediatric to adult healthcare systems. We did not systematically distinguish between intervention and observed data research during screening, limiting subgroup analyses by evidence type. Sample size variations across studies create challenges in generalizing findings, with underrepresentation of specific groups, cultural variability, and methodological heterogeneity further limiting comparability. Additionally, we synthesized findings across diverse disability policy environments and health system contexts, including countries with different disability rights legislation, healthcare financing models (universal, mixed, private), and levels of accessibility enforcement without systematically accounting for how these policy and system-level differences may shape the barriers and facilitators identified. This variability limits our ability to provide context-specific recommendations.
+
+Despite these limitations, we believe that this review has produced solid evidence that should be taken into consideration for future research and policy development.
+
+Future research should focus on longitudinal, intersectional, and participatory studies to evaluate barriers, interventions, and effective healthcare strategies. Systems, policymakers, and providers must prioritize accessibility, staff training, inclusive policies, and patient-centered care. Without this deeper transformation, the barriers documented in this review are likely to persist, while disabled people continue to suffer preventable health consequences and premature deaths. We acknowledge that future reviews could benefit from a priori classification of evidence types intervention vs. observed facilitators during screening to enable subgroup analyses by methodological rigor. Based on the patterns identified in this review, we argue that the path forward requires healthcare systems to critically examine how current practices may create barriers for people with disabilities.
+
+Conclusions
+
+This comprehensive review reveals persistent, multifaceted healthcare access barriers for people with disabilities across diverse global contexts at multiple healthcare system levels, with diverse methods and recent focus ensuring timely, relevant findings. Disparities persist across both high- and low-income countries, demonstrating economic wealth does not guarantee health equity. The reviewed evidence shows barriers span six interconnected areas and points to key concerns, despite disability rights legislation, accessibility is typically addressed through individualized accommodations rather than systematic universal design. The medical model overshadows disabling barriers; and patterns of reduced treatment access and delayed care raise questions about priority-setting in healthcare systems. The reviewed studies document that healthcare professionals often lack disability knowledge and hold negative attitudes compromising care quality, while technological solutions retrofit general approaches rather than integrating accessibility, exposing fundamental innovation flaws. These findings highlight that barriers are neither inevitable nor acceptable and cannot be resolved at individual provider or patient levels. Their persistence reflects normalized systemic discrimination, underscoring the need for systemic redesign, political prioritization, and fundamental reframing of disability as central to health equity rather than marginal. Future research should evaluate interventions and effective strategies rather than documenting the same barriers.
+
+Data availability statement
+
+The original contributions presented in the study are included in the article/Supplementary material, further inquiries can be directed to the corresponding author/s.
+
+Author contributions
+
+MC: Writing review & editing, Writing original draft. GM: Writing original draft, Writing review & editing. KS: Software, Conceptualization, Visualization, Funding acquisition, Writing review & editing, Writing original draft, Resources, Investigation, Formal analysis, Validation, Project administration, Data curation, Supervision, Methodology. DN: Investigation, Writing original draft, Funding acquisition, Software, Resources, Conceptualization, Supervision, Visualization, Project administration, Writing review & editing, Validation, Data curation, Methodology, Formal analysis. RS: Writing review & editing, Writing original draft. OZ: Writing review & editing, Writing original draft. SG: Writing review & editing. FL: Writing review & editing. VN: Writing review & editing. AM: Writing review & editing. EB: Writing review & editing, Writing original draft. GL: Writing original draft, Writing review & editing. LP: Writing original draft, Writing review & editing.
+
+Conflict of interest
+
+The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
+
+Generative AI statement
+
+The author(s) declared that generative AI was not used in the creation of this manuscript.
+
+Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Supplementary material
+
+The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fpubh.2026.1765145/full#supplementary-material
+
+Edited by: Faris Lami, University of Baghdad, Iraq
+
+Reviewed by: Carrie Wendel, University of Kansas, Lawrence, KS, United States
+
+Moumita Roy, Louisiana State University, United States
+
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Cad Saude Publica
+Journal ID: Cad Saude Publica
+NLM Journal ID: 8901573
+Journal ID: csp
+
+Cadernos de Saúde Pública
+
+ISSN: 0102-311X
+EISSN: 1678-4464
+Publisher: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13460900
+PMID: 42585508
+DOI: 10.1590/0102-311XEN274825
+Article ID: 03807
+Article version: 1
+Subjects: Review
+
+Digital health promotion strategies to increase HIV testing uptake among key populations: a scoping review
+
+Estratégias digitais de promoção da saúde para aumentar a aceitação de testes de HIV entre populações-chave: uma revisão de escopo
+
+Estrategias digitales de promoción de la salud para aumentar la aceptación de pruebas de VIH entre poblaciones clave: una revisión de alcance
+
+https://orcid.org/0000-0002-6990-7263 Syamsir Syamikar Baridwan study conception and design data analysis writing, and critical review approved the final version 1
+https://orcid.org/0009-0006-4593-8301 Naralia T. Widya data analysis writing, and critical review approved the final version 1
+https://orcid.org/0009-0005-1928-3148 Rahayu Hesti data analysis writing, and critical review approved the final version 1
+https://orcid.org/0000-0002-9634-3491 Pamungkas Eny Dewi data analysis writing, and critical review approved the final version 1
+https://orcid.org/0009-0000-3633-8562 Diorarta Raphita data analysis writing, and critical review approved the final version 1
+https://orcid.org/0000-0003-0501-8982 Setiawan Agus study conception and design data analysis writing, and critical review approved the final version 2
+https://orcid.org/0000-0002-3299-2820 Pamungkas Rian Adi critical review approved the final version 3
+https://orcid.org/0000-0003-0254-2447 Zainuddin Zainuddin writing, and critical review approved the final version 4
+1 Faculty of Health Sciences, Universitas Pembangunan Nasional Veteran Jakarta, Jakarta, Indonesia.
+2 Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.
+3 Faculty of Health Sciences, Universitas Esa Unggul, Jakarta, Indonesia.
+4 Faculty of Public Health, Universitas Pejuang Republik Indonesia, Makassar, Indonesia.
+Correspondence S. B. Syamsir Jl. R.S. Fatmawati No. 1, Cilandak, South Jakarta 12450, Indonesia. syamikarbaridwan@upnvj.ac.id Evaluation coordinator: Associate Editor: Laio Magno (0000-0003-3752-0782)
+
+Electronic publication date: 2026 Aug 10
+Publication date: 2026
+Volume: 42
+Electronic Location ID: e00274825
+Received 2025 Dec 24; Revised 2026 May 7; Accepted 2026 May 11
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: HIV Testing, Health Promotion, Digital Technology, Vulnerable Populations, Scoping Review
+Keywords: Teste de HIV, Promoção da Saúde, Tecnologia Digital, Populações Vulneráveis, Revisão de Escopo
+Keywords: Prueba de VIH, Promoción de la Salud, Tecnología Digital, Poblaciones Vulnerables, Revisión de Alcance
+Figure count: 1
+Table count: 4
+Equation count: 0
+Reference count: 62
+
+Ÿ==============================Ÿ
+Abstract:
+
+HIV testing uptake among key populations remains suboptimal despite its central role in HIV prevention. Digital health promotion strategies have been increasingly implemented to address multilevel barriers to testing. However, current evidence is fragmented across platforms, populations, and settings. This scoping review aimed to map and synthesize current evidence on digital health promotion strategies designed to increase HIV testing uptake among key populations. This scoping review adopted Arksey & O’Malley’s five-stage framework and reported the process following PRISMA-ScR. PubMed, Scopus, the Cochrane Library, and CINAHL were searched for studies published from January 2015 to April 2025. Eligible studies examined digital health promotion strategies focused on HIV testing uptake among key populations. Sixteen studies were included. We identified four thematic clusters of digital health promotion strategies. Overall, the identified approaches showed potential to increase testing uptake and reduce barriers; however, evidence remains heterogeneous and uneven across populations and settings. Digital strategies for HIV testing are complementary. Integrating mobile apps, social media outreach, digital messaging, and peer-driven networks may offer scalable, context-sensitive solutions for key populations. However, the limited representation of certain groups, particularly transgender women and people who inject drugs, highlights important gaps in the evidence base. Further studies with more robust design, wider geographic coverage, and longer follow-up are warranted.
+
+Resumo:
+
+A adoção dos testes de HIV entre populações-chave continua abaixo do ideal, apesar de seu papel central na prevenção do HIV. Estratégias digitais de promoção da saúde têm sido implementadas com mais frequência para enfrentar barreiras multinível aos testes. No entanto, a evidência acerca desse fato se encontra dividida entre plataformas, populações e ambientes. Esta revisão de escopo buscou mapear e sintetizar a evidência acerca de estratégias para promover saúde digital que foram projetadas para aumentar a aceitação de testes de HIV entre populações-chave. Adotou-se o quadro de cinco etapas de Arksey e O’Malley, relatando o processo de acordo com o PRISMA-ScR. Pesquisa bibliográfica foi conduzida nas plataformas PubMed, Scopus, Biblioteca Cochrane e CINAHL buscando estudos publicados entre janeiro de 2015 e abril de 2025. Estudos elegíveis analisaram estratégias de promoção da saúde digital que focaram na aceitação de testes de HIV em populações-chave. Ao todo, 16 estudos foram incluídos. Identificamos quatro grupos temáticos de estratégias de promoção da saúde digital. No geral, as abordagens identificadas podem aumentar a adesão aos testes e reduzir barreiras, a despeito da evidência heterogênea e desigual entre populações e ambientes. Estratégias digitais para testes de HIV são complementares. Integrar aplicativos móveis, alcance em redes sociais, mensagens digitais e redes baseadas em pares pode oferecer soluções escaláveis e sensíveis ao contexto das populações-chave. No entanto, a representação limitada de certos grupos, especialmente mulheres transgênero e pessoas que usam drogas injetáveis, destaca lacunas importantes na base de evidências. Estudos adicionais com desenhos mais robustos, maior cobertura geográfica e acompanhamento mais longo são necessários.
+
+Resumen:
+
+La adopción de pruebas de VIH entre las poblaciones clave sigue estando por debajo de lo ideal, a pesar de su papel fundamental para prevenir el VIH. Las estrategias digitales de promoción de la salud se han implementado cada vez más para hacer frente a las barreras multinivel para la realización de pruebas. Sin embargo, la evidencia sobre este hecho está dividida entre plataformas, poblaciones y entornos. Esta revisión de alcance tuvo como objetivo mapear y sintetizar la evidencia sobre estrategias para promover la salud digital, diseñadas para aumentar la aceptación de las pruebas de VIH entre poblaciones clave. Se adoptó la metodología de cinco etapas de Arksey & O’Malley, reportando el proceso según el PRISMA-ScR. La investigación bibliográfica se realizó en las plataformas PubMed, Scopus, Biblioteca Cochrane y CINAHL mediante la búsqueda de estudios publicados entre enero de 2015 y abril de 2025. Los estudios elegibles analizaron las estrategias de promoción de la salud digital, centradas en la aceptación de pruebas de VIH en poblaciones clave. En total, se incluyeron 16 estudios. Identificamos cuatro grupos temáticos de estrategias de promoción de la salud digital. En general, los enfoques identificados pueden aumentar la adherencia a las pruebas y reducir las barreras, a pesar de la evidencia heterogénea y desigual entre poblaciones y entornos. Las estrategias digitales para pruebas de VIH son complementarias. Integrar las aplicaciones móviles, el alcance en redes sociales, los mensajes digitales y las redes basadas en pares puede ofrecer soluciones escalables y sensibles al contexto de las poblaciones clave. Sin embargo, la limitada representación de determinados grupos, sobre todo las mujeres transgénero y las personas que consumen drogas inyectables, resalta importantes brechas en la base de evidencias. Se necesitan más estudios con diseños más robustos, mayor cobertura geográfica y seguimiento más prolongado.
+
+Introduction
+
+HIV/AIDS remains a major global public health concern. In 2024, an estimated 40.8 million people were living with HIV, with approximately 630,000 deaths reported worldwide, 65% of cases concentrated in the WHO (World Health Organization) African Region, and an estimated 5.3 million people unaware of their HIV status 1 . Delayed diagnosis contributes to increased mortality and continued HIV transmission 2 . HIV testing plays a central role in epidemic control because it enables timely initiation of antiretroviral therapy (ART) and guides HIV-negative individuals as to prevention options such as pre-exposure prophylaxis (PrEP), both of which improve outcomes and reduce onward transmission 3 . However, global testing coverage remains suboptimal due to factors such as stigma, discrimination, limited service availability, and concerns about confidentiality 4 . In addition, substantial regional disparities persist, with variations in HIV incidence and testing coverage across regions. While sub-Saharan Africa bears the highest burden, other regions such as Latin America and Eastern Europe continue to report considerable numbers of new infections alongside uneven progress in testing and treatment coverage 5 . When individuals are unaware of their HIV status, early diagnosis opportunities are missed, disease progression often goes undetected, and health care costs rise, with economic modelling showing that early access to care is cost-saving and prevents secondary infections 6 . Limited testing reinforces social stigma and psychosocial stress, particularly in settings with low health literacy 7 , 8 .
+
+Testing inequalities are most evident among key populations, including men who have sex with men (MSM), transgender people, sex workers, and people who inject drugs (PWID), whose HIV prevalence is substantially higher than in the general population 9 . Structural factors such as criminalization, discrimination, and the scarcity of humanized and inclusive healthcare services further heighten the vulnerability of these groups 10 . Strategies to increase HIV testing coverage should therefore prioritize these populations through contextual, participatory, and needs-oriented approaches. Understanding the drivers and barriers of testing decisions is essential. Common facilitators include perceived personal risk, social support, ease of access to services, and the presence of HIV-related symptoms 11 . Barriers include stigma and discrimination, fear of a positive result, limited HIV knowledge, and concerns about confidentiality 11 , 12 . These insights can underpin more responsive interventions such as targeted counselling and enhanced social support during and after HIV self-testing distribution 13 . These structural barriers underscore the need for innovative and context-sensitive approaches, with digital health strategies offering potential to improve confidentiality, expand access, and address limitations of conventional HIV testing services.
+
+Advances in digital technology create new opportunities to expand HIV testing. Telehealth, mobile health applications, social media campaigns, and SMS-based reminder systems have been shown to extend service reach, reduce distance-related barriers, and improve access to HIV-related information and testing services, particularly in resource-constrained settings 14 , 15 . Digital strategies enable more personalized health promotion through tailored support and promote interaction through social features and peer support, which helps deliver relevant and accessible health messages to users 16 . Other evidence indicates that digital media can increase engagement with and acceptability of health interventions, particularly among vulnerable populations 17 , 18 .
+
+Despite the increase in digital health promotion strategies, there is still a gap in the systematic documentation and mapping of these approaches, especially for key populations across diverse settings. Previous scoping reviews have discussed digital HIV testing promotion strategies, including social network-based approaches 19 . However, their scope was largely confined to social network-based methods. To date, no scoping review has comprehensively mapped the full spectrum of digital health promotion strategies to increase HIV testing uptake among key populations across global contexts. Therefore, this scoping review aims to identify and map digital technology-based health promotion strategies used to expand HIV testing among key populations. The findings are intended to provide a conceptual and empirical basis for developing more effective digital interventions, inform evidence-based health policy, and reinforce global efforts to control the HIV epidemic.
+
+Methods
+
+Design
+
+This scoping review adopted Arksey & O’Malley’s five-stage methodological framework, comprising: (1) identifying the research question, (2) identifying relevant studies, (3) selecting studies, (4) charting the data, and (5) collating, summarizing, and reporting the results 20 . The reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist 21 .
+
+Stage 1: Identifying the research question
+
+This review was guided by the following research question: what digital health promotion strategies have been implemented to increase HIV testing uptake among key populations? The question was formulated to capture a broad range of digital health interventions that aim to increase HIV testing uptake specifically within key populations, including MSM, transgender people, sex workers, PWID, and adolescents and young people within key populations. This formulation aligns with the exploratory purpose of a scoping review, which is to map existing evidence and identify knowledge gaps rather than evaluate intervention effectiveness. Given the heterogeneity of digital health interventions, study designs, and implementation contexts, as well as the fragmented nature of the available evidence, a scoping review approach was considered more appropriate than a systematic review. This approach enables comprehensive mapping of diverse strategies and identification of research gaps, rather than focusing on the effectiveness of specific interventions 22 .
+
+Stage 2: Identifying relevant studies
+
+The identification of relevant studies was guided by the Population-Concept-Context (PCC) framework as recommended by the JBI for scoping reviews 23 . The population included individuals from key populations, such as MSM, transgender people, sex workers, PWID, and adolescents and young people within key populations. Studies involving general populations were included only if they explicitly addressed these subgroups. The concept focused on health promotion strategies using digital technologies designed to increase HIV testing uptake, including HIV self-testing approaches. The context encompassed all geographical and sociocultural settings globally, without restrictions on location or healthcare system characteristics.
+
+This scoping review considered a broad range of study designs, including randomized controlled trials (RCTs), quasi-experimental studies, observational studies, mixed-methods studies, and study protocols, to comprehensively map current evidence on digital health promotion strategies for HIV testing uptake. This approach is consistent with the purpose of scoping reviews, which aim to address broad research questions and include heterogeneous evidence sources 22 .
+
+A systematic search was conducted in four electronic databases: PubMed, Scopus, the Cochrane Library, and CINAHL. These databases were selected to capture a comprehensive body of biomedical evidence (PubMed), multidisciplinary and international literature (Scopus), evidence syntheses (Cochrane Library), and nursing, behavioral, and community-based studies relevant to digital health interventions (CINAHL).
+
+The search strategy combined keywords, Boolean operators (AND, OR), and Medical Subject Headings (MeSH) where applicable. Search terms were organized into four conceptual domains: digital health (including mobile, web-based, and social media-related approaches), HIV, health promotion, and key populations. These domains were combined using the AND operator to retrieve studies aligned with the scope of this review.
+
+The search strategy was developed iteratively to ensure both sensitivity and specificity, with refinement of keywords and combinations across databases. The initial strategy was developed for PubMed and subsequently adapted for the other databases, taking into account differences in indexing systems, thesaurus structures, and controlled vocabularies used in each database. To enhance transparency and reproducibility, full search strategies for each database, including Boolean logic, nested keyword combinations, and MeSH term applications, are provided in Supplementary Material (https://cadernos.ensp.fiocruz.br/static//arquivo/suppl-e00274825_8421.pdf).
+
+Stage 3: Selecting studies
+
+All records identified through the database searches were imported into Mendeley Reference Manager (https://www.mendeley.com) for duplicate removal. Study selection was conducted in two stages: an initial screening of titles and abstracts, followed by full-text assessment. Two independent reviewers applied predefined inclusion and exclusion criteria at both stages. Articles that were considered potentially relevant or unclear during the initial screening were retained for full-text review. Any discrepancies between reviewers were resolved through discussion until consensus was reached.
+
+Studies were included if they focused on digital health promotion strategies aimed at increasing HIV testing uptake among key populations, including MSM, transgender people, sex workers, PWID, and adolescents and young people within key populations. Eligible studies were published in English between January 2015 and April 2025. Studies were excluded if they did not involve digital health promotion strategies, did not report outcomes related to HIV testing uptake, or were conducted in general populations without specific analysis of key populations. Studies reporting indirect, behavioral, feasibility, or implementation-related outcomes relevant to HIV testing uptake were retained if they provided meaningful insights into digital HIV testing promotion strategies. Non-empirical publications, such as editorials, commentaries, and opinion pieces, were also excluded.
+
+Study protocols and modelling studies were included when they provided detailed descriptions of planned or simulated digital health promotion strategies relevant to HIV testing uptake. These studies were used to map intervention components but were not considered as empirical outcome evidence. Screening decisions were documented using a structured spreadsheet in Google Sheets (https://docs.google.com/spreadsheets). The restriction to English-language publications was applied to ensure consistency in data extraction and interpretation, while recognizing the potential exclusion of relevant studies from non-English-speaking and low-resource settings. The final search was conducted in April 2025.
+
+The study selection process was documented and reported following the PRISMA-ScR guidelines. A PRISMA 2020 flow diagram (Figure 1) presents the number of records identified, screened, assessed for eligibility, and included in the final review.
+
+Figure 1 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 flow diagram of the study selection process.
+
+Stage 4: Charting the data
+
+Data extraction adopted a standardized charting form developed for this review. The data extraction form used in this review is provided in Supplementary Material (https://cadernos.ensp.fiocruz.br/static//arquivo/suppl-e00274825_8421.pdf). The form captured key study characteristics, including: author(s) and year of publication, country or region, study population (restricted to key populations such as MSM, transgender people, sex workers, PWID, and adolescents and young people within key populations), sample size, study design, study objectives, type of digital health promotion strategy or intervention, key findings related to HIV testing uptake, and thematic category or subtheme.
+
+Two reviewers independently piloted the charting form on six randomly selected articles to ensure clarity, consistency, and feasibility 24 . Based on this pilot, the charting form was refined to ensure systematic and comprehensive capture of all relevant information.
+
+To enhance transparency, the methodological quality of included studies was appraised but not used as an exclusion criterion. Quantitative, qualitative, and mixed-methods studies were assessed using the Mixed Methods Appraisal Tool (MMAT, 2018 version) 25 , while review studies (systematic or scoping) were appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses 26 . Appraisal results were summarized descriptively to provide context regarding the strengths and limitations of the available evidence. These assessments informed interpretation of the findings without being used as exclusion criteria. Two reviewers conducted the appraisal independently, with any disagreements resolved through discussion.
+
+Stage 5: Collating, summarizing, and reporting the results
+
+The included studies were grouped by article type, study design, country or region, key population, and the type of digital health promotion strategy implemented. A descriptive numerical summary of study characteristics was first generated to provide an overview of the included evidence.
+
+Thematic analysis was then conducted using an iterative and inductive approach, consistent with established guidance for scoping reviews 24 . Two reviewers independently coded the extracted data to identify initial concepts related to digital health promotion strategies for HIV testing uptake. These codes were subsequently organized into subthemes, which were further refined and consolidated into broader thematic categories through discussion and consensus. Discrepancies in coding and theme development were resolved through iterative comparison and agreement between reviewers. Data coding and management were conducted manually using structured spreadsheets. This process ensured consistency and transparency in the development of themes and subthemes. The predefined thematic categories included mobile app-based interventions, social media and web-based outreach, messaging-based strategies, and peer- and network-based digital approaches.
+
+Finally, the identified themes were compared across studies to identify overarching patterns and variations in digital health promotion strategies. A narrative thematic synthesis of the findings is presented in the Results section.
+
+Results
+
+Study selection
+
+The initial search across four electronic databases (Scopus, PubMed, the Cochrane Library, and CINAHL) retrieved 1,616 records. After deduplication and sequential screening of titles, abstracts, and full texts, 16 studies met the inclusion criteria and were included in this scoping review. During the title and abstract screening stage, studies were excluded primarily because they were not related to digital health interventions, did not address HIV testing uptake, or did not involve key populations. Studies were excluded at the full-text reading stage primarily because they did not involve digital health promotion strategies, did not focus on HIV testing uptake outcomes, or targeted general populations without addressing key populations. In line with the protocol, study protocols and modelling studies were retained when they provided substantial descriptions of planned or simulated digital strategies relevant to HIV testing uptake in key populations, although they did not contribute empirical outcome data. The selection process is summarized in the PRISMA 2020 flow diagram (Figure 1).
+
+Characteristics of included studies
+
+A total of 16 studies were included, with most conducted in the United States and Asian settings, particularly China and Hong Kong, alongside several studies from Malaysia, India, and broader low- and middle-income countries (LMICs) or multi-country contexts. Most studies focused on MSM or young MSM, while a smaller number addressed transgender people, sex workers, adolescents, or other key populations. Sample sizes varied widely, ranging from small pilot trials with fewer than 50 participants to large-scale RCTs, program evaluations, and review-level evidence involving several thousand participants across multiple settings.
+
+Across the included studies, digital interventions were implemented in diverse contexts, including community-based organizations (CBOs), public health programs, and digitally mediated environments such as mobile applications and online platforms. Several interventions were delivered through community-based organizations or outreach programs 27 , 28 , while others operated within broader digital ecosystems, including app-based services and online advertising platforms 29 , 30 , 31 , 32 . These variations reflect differences in implementation settings, with most studies evaluating active digital interventions targeting MSM and young MSM populations, and highlight the potential scalability of digital interventions across community and digitally integrated health systems.
+
+With respect to study design, the included studies comprised RCTs (n = 3) plus one pilot RCT (n = 1), one quasi-experimental study (n = 1), mixed-methods feasibility or pilot studies (n = 3), cross-sectional quantitative studies (n = 2), one quantitative program case study (n = 1), systematic reviews and meta-analyses (n = 2), and study protocols (n = 3). Pilot RCTs and protocols were preserved as distinct categories to avoid inflating efficacy evidence, as these studies primarily describe planned or preliminary interventions rather than providing empirical outcome data. This heterogeneity reflects the evolving state of research on digital strategies for HIV testing, in which both formative pilot work and large-scale evaluations contribute to the evidence base.
+
+Across the studies, mobile applications (approximately six studies) emerged as the most frequently reported digital approach. Common features included personalized reminders, geolocation services, HIV self-testing (HIVST) kit ordering, and linkage to information about PrEP. Social media campaigns and SMS-based reminders were also widely applied, particularly in settings with broad digital access. Several studies leveraged peer-network strategies, including peer recruitment and secondary distribution of HIVST kits through digital platforms, as well as crowdsourced interventions. Two systematic reviews and meta-analyses synthesized evidence across multiple contexts and reported pooled associations between digital strategies and higher HIV testing uptake among key populations. Overall, multiple studies documented higher HIV testing uptake associated with digital strategies, with effects most consistently observed in app-based and social-media-based interventions among MSM and young MSM, while other key populations remained less represented in the evidence base. Detailed study characteristics are summarized in Box 1.
+
+Box 1 Characteristics of included studies (n = 16).
+
+No.	STUDY (YEAR)	COUNTRY/REGION	POPULATION	SAMPLE SIZE	STUDY DESIGN	OBJECTIVE	DIGITAL STRATEGY/ INTERVENTION	KEY FINDINGS (HIV TESTING UPTAKE)	
+1	He et al. 38 (2025)	China (Zhejiang Province)	MSM	n = 4,600	Cross-sectional (quantitative descriptive)	Compare the effectiveness of mobile social media-based vs. volunteer-driven recruitment	Mobile social media vs. volunteer-driven recruitment; mailed HIVST vs. offline testing	Mobile social media recruited more first-time testers (19.5% vs. 17.4%); higher positivity (1.7% vs. 0.9%); associated with mail-in HIVST (aOR = 2.02)	
+2	Biello et al. 33 (2019)	United States (Boston and Bronx)	Young MSM (15-24 years)	Phase 1: n ≈ 30; phase 2: n ≈ 15; pilot RCT: n = 60	Protocol - pilot RCT (3-phase)	Describe the development and initial testing of the MyChoices app	MyChoices mobile app: self-assessment, reminders, geofencing, HIVST kit ordering, PrEP information	No empirical results (protocol); expected to increase HIV testing and PrEP uptake	
+3	Wang et al. 28 (2024)	Hong Kong SAR	MSM (Chinese-speaking)	Intervention: n = 400; control: n = 412	Quasi-experimental (prospective comparison, 6-month follow-up)	Evaluate an online HIVST promotion program run by a CBO during the pandemic	Online video; webpage information; HIVST kit delivery; live chat; SMS/instant messaging reminders	Greater HIV testing uptake (57% vs. 49%; aOR = 1.43); higher HIVST uptake (25.8% vs. 14.8%; aOR: 2.04)	
+4	Nicely et al. 39 (2025)	LMICs (Kenya, South Africa, Uganda, China)	MSM, refugee youth, CBO users	5 studies; total n = 2,581	Systematic review and meta-analysis	Assess digital health modalities in LMICs	SMS, social media, HIVST apps, online peer groups	Pooled HIVST uptake 83.5% vs. 66.8%; confirmation 82.5% vs. 25.1%	
+5	Shrestha et al. 36 (2023)	Malaysia (Kuala Lumpur)	MSM (PrEP-naive, HIV-negative or unknown status)	n = 50	Mixed-methods (single-arm beta test, 30-day follow-up)	Evaluate the JomPrEP mobile app	JomPrEP app: HIVST ordering, e-consultation, reminders, rewards	84% ordered an HIVST kit; 95% verified results; the app facilitated access to testing	
+6	Liu et al. 34 (2019)	United States (Chicago and Tampa)	Young MSM (15-24 years)	Pilot RCT: n = 60 (2:1)	Protocol - pilot RCT	Develop the LYNX app	LYNX app: sexual diary, personalized risk score, reminders, HIVST ordering, geolocation, PrEP information	No empirical results (protocol)	
+7	Biello et al. 29 (2021)	United States (Boston and Bronx)	Young MSM (15-24 years)	Theatre testing: n = 28; technology pilot: n = 11	Mixed-methods (formative plus pilot)	Develop and evaluate the MyChoices app	MyChoices app: reminders, GPS locator, HIVST kit ordering, safer-sex supplies, PEP information	91% used the app; 91% felt motivated to test for HIV; 73% reported the app facilitated testing	
+8	Lin et al. 40 (2023)	China (Shandong, 11 cities)	MSM (≥ 18 years)	Enrolled: n = 935; intervention: n = 404; control: n = 531	Cluster RCT (12-month follow-up)	Evaluate a multilevel crowdsourced intervention via WeChat	WeChat digital materials; free HIVST kits; peer groups; videos	Higher HIV testing at 6-12 months; peer groups and video components were most effective	
+9	Biello et al. 31 (2025)	United States (9 cities)	Sexual minority men (15-29 years)	n = 381 (RCT, 3-arm)	RCT (6-month follow-up)	Compare MyChoices and LYNX vs. standard of care	Apps: reminders, HIVST kit ordering, geolocation, PrEP information	HIV testing at least once over 6 months: 74% (MyChoices) vs. 59% (standard of care), RR = 1.27	
+10	Biello et al. 30 (2022)	United States (Boston, Bronx, Chapel Hill)	Young MSM (15-24 years)	n = 60 (2:1 RCT)	Pilot RCT (6-month follow-up)	Evaluate preliminary efficacy of the MyChoices app	MyChoices: reminders, geolocation, HIVST ordering, multimedia content	HIV testing uptake: 79% vs. 65% (not statistically significant); acceptable usability (SUS, mean = 75.8)	
+11	Lightfoot et al. 27 (2018)	United States (California)	African-American and Latino MSM (18-45 years)	Peer recruiters: n = 28; HIVST kits: n = 165	Quantitative descriptive (network evaluation)	Evaluate HIVST distribution through peer recruiters	Peer recruiters distributed HIVST via CBOs, venues, and apps	Higher positivity 6.14% vs. 1.49%; reached non-testers	
+12	Veronese et al. 41 (2020)	Global (HIC and LMIC: United States, Hong Kong, Taiwan, China, Peru, India)	MSM and TGW	13 studies; total: n = 8,875	Systematic review and meta-analysis	Assess the impact of digital communication technologies on HIV testing	Social media, online video, instant messaging/email, live chat, HIVST referral	Pooled RR for testing uptake = 1.5; social media RR = 1.7	
+13	Zhou et al. 37 (2022)	China (68 cities)	MSM (≥ 18 years)	Index: n = 309; control: n = 102; alters: n = 334	RCT (3-arm, online)	Evaluate peer referral with cash incentives	WeChat kit ordering and reporting; referral links; e-incentives	Increased number of testers (IRR: 2.98 to 3.26); increased newly tested alters (IRR: 3.49 to 4.22)	
+14	Chaudary et al. 35 (2024)	India (Mumbai-Thane)	MSM (≥ 18 years, non/recent testers)	Target: n = 1,000	Protocol - RCT (3-arm)	Test the effectiveness of CHALO! 2.0	WhatsApp multimedia campaign; digital coupons; peer outreach	Protocol; results not yet available	
+15	Lee et al. 42 (2022)	United States (Washington State)	Latinx immigrant sexual minority men (≥ 18 years)	Focus groups: n = 15; website visitors: n = 739; survey: n = 60	Mixed-methods (feasibility)	Evaluate a culturally tailored social media campaign	Social media (Facebook/Instagram) leading to a bilingual website with HIV testing/PrEP information	739 users reached; 70% had tested in the past 6 months; effectiveness for uptake not measured	
+16	Chambers et al. 32 (2024)	United States (Rhode Island)	MSM (gay and bisexual)	2,536,405 impressions; 35,022 clicks; 225 conversions	Quantitative descriptive (case study)	Evaluate performance of a multi-platform digital advertising programme	Google Search, Display, Grindr, and Facebook ads	Google Search click-through rate 7.1%; conversion rate 7.0% (proxy for uptake)	
+aOR: adjusted odds ratios; CBO: community-based organization; GPS: global positioning system; HIC: high-income countries; HIVST: HIV self-testing; IRR: incidence rate ratio; LMIC: low- or middle-income countries; MSM: men who have sex with men; PEP: post-exposure prophylaxis; PrEP: pre-exposure prophylaxis; RCT: randomized controlled trial; RR: risk ratio; SUS: System Usability Scale; TGW: transgender women.
+
+Methodological quality appraisal
+
+Although quality appraisal is not mandatory in scoping reviews, a descriptive assessment was conducted to contextualize the robustness of the evidence without serving as an exclusion criterion. Among the 11 primary studies appraised, overall methodological quality was moderate to high, with no study scoring below 3 out of 5 MMAT criteria. Three study protocols 33 , 34 , 35 were also descriptively appraised to document planned methodological rigor and were not considered outcome evidence. The two included systematic reviews achieved high methodological quality ratings (10/11), indicating robust methodological rigor despite minor limitations. Detailed appraisal results are presented in Boxes 2 and 3.
+
+Box 2 Quality appraisal of primary studies using Mixed Methods Appraisal Tool (MMAT, 2018 version).
+
+No. *	STUDY (YEAR)	STUDY DESIGN	Q1	Q2	Q3	Q4	Q5	OVERALL QUALITY	
+1	He et al. 38 (2025)	Quantitative descriptive	Yes	No	Yes	No	Yes	3/5 (moderate)	
+2	Biello et al. 33 (2019)	Protocol (pilot RCT)	Yes	Yes	No	No	Yes	3/5 (moderate - protocol)	
+3	Wang et al. 28 (2024)	Quantitative non-randomized	No	Yes	Yes	Yes	Yes	4/5 (high)	
+5	Shrestha et al. 36 (2023)	Mixed methods	Yes	Yes	Yes	Yes	No	4/5 (high)	
+6	Liu et al. 34 (2019)	Protocol (pilot RCT)	Yes	Yes	No	No	Yes	3/5 (moderate - protocol)	
+7	Biello et al. 29 (2021)	Mixed methods	Yes	Yes	Yes	Yes	No	4/5 (high)	
+8	Lin et al. 40 (2023)	RCT, cluster	Yes	Yes	Yes	No	Yes	4/5 (high)	
+9	Biello et al. 31 (2025)	RCT (3-arm)	Yes	Yes	Yes	No	Yes	4/5 (high)	
+10	Biello et al. 30 (2022)	Pilot RCT	Yes	Yes	Yes	No	Yes	4/5 (high)	
+11	Lightfoot et al. 27 (2018)	Quantitative descriptive	Yes	No	Yes	No	Yes	3/5 (moderate)	
+13	Zhou et al. 37 (2022)	RCT	Yes	Yes	Yes	No	Yes	4/5 (high)	
+14	Chaudary et al. 35 (2024)	Protocol (RCT)	Yes	Yes	No	Yes	Yes	4/5 (high - protocol)	
+15	Lee et al. 42 (2022)	Mixed methods	Yes	Yes	Yes	No	No	3/5 (moderate)	
+16	Chambers et al. 32 (2024)	Quantitative descriptive	Yes	No	Yes	No	Yes	3/5 (moderate)	
+RCT: randomized controlled trial.
+
+Note: Q1 - study design appropriateness; Q2 - data quality; Q3 - outcome completeness; Q4 - risk of bias; Q5 - analytical rigor, adapted from the MMAT.
+
+* Numbering aligns with Box 1.
+
+Box 3 Quality appraisal of systematic reviews using the JBI 11-item checklist.
+
+No. *	STUDY (YEAR)	STUDY DESIGN	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	Q11	OVERALL QUALITY	
+4	Nicely et al. 39 (2025)	Systematic review & meta-analysis	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	10/11 (High)	
+12	Veronese et al. 41 (2020)	Systematic review & meta-analysis	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	10/11 (High)	
+Note: Q1 - review question clarity; Q2 - appropriateness of inclusion criteria; Q3 - adequacy of search strategy; Q4 - adequacy of sources; Q5 - appropriateness of appraisal criteria; Q6 - independent critical appraisal; Q7 - error minimization in data extraction; Q8 - appropriateness of synthesis methods; Q9 - assessment of publication bias; Q10 - support for recommendations; Q11 - appropriateness of future research directions (JBI critical appraisal checklist).
+
+* Numbering aligns with Box 1.
+
+Thematic analysis
+
+A thematic analysis was conducted to map the range of digital, technology-enabled health promotion strategies used to increase HIV testing uptake among key populations. From the 16 included studies, four overarching themes emerged that represent consistent intervention patterns across studies. These themes reflect diverse technological approaches, spanning mobile applications, social media and web-based outreach, digital messaging, and peer- and network-based strategies. A summary of themes, subthemes, and operational definitions is presented in Box 4.
+
+Box 4 Thematic analysis.
+
+THEME	SUBTHEME	DEFINITION	
+Theme 1: Mobile app-based strategies	Mobile apps	Purpose-built mobile applications that support HIV testing and prevention, functioning as integrated platforms for digital services, for example MyChoices, LYNX, and JomPrEP	
+Personalized reminders	Tailored notifications based on user profiles or needs to prompt routine and scheduled HIV testing	
+Gamification and rewards	Game elements, points, or incentives embedded in apps to enhance motivation to test for HIV	
+Integration with clinic and e-consultation	App-based links to clinic services, including e-consultation, chat with health professionals, and access to results or test ordering	
+Geolocation and in-app support	Location-based features and in-app support such as chat or real-time information to facilitate access to HIV testing services	
+Digital HIVST ordering and reporting (app)	In-app facilities for ordering HIVST kits and reporting results digitally	
+Theme 2: Social media and web-based outreach	Social media campaigns	Educational and promotional HIV testing campaigns delivered through social media platforms, using general or targeted messaging	
+Online video campaigns	Dissemination of educational video or multimedia content online to increase motivation for HIV testing	
+Culturally tailored social media	Social media campaigns adapted to the culture, language, or context of target communities	
+Website click-through	Strategies that direct users from social media or advertisements to dedicated landing pages for information or access to HIV testing services	
+Web-based education	Provision of structured, interactive web pages with HIV testing information and guidance	
+Targeted digital advertising	Paid digital advertisements on search engines, display networks, or geosocial apps targeting at-risk populations to increase testing uptake	
+Digital HIVST facilitation (web or social)	Web or social media-based facilitation of HIV self-testing, including kit ordering, instructions, live-chat assistance, and result reporting	
+Theme 3: Digital messaging (SMS and WhatsApp)	SMS campaigns	Short message service reminders, education, or promotional messages to increase HIV testing uptake	
+WhatsApp campaigns	Educational broadcasts or two-way interactions via WhatsApp or WhatsApp Business to support HIV testing decisions	
+Theme 4: Peer and network-based digital strategies	Peer distribution of HIVST	Distribution of HIVST kits through peer networks supported by digital tools to expand reach	
+Digital peer recruitment	Recruitment for HIV testing through digital platforms leveraging social or peer networks	
+Peer referral links	Unique digital links that enable peers to refer others to order HIVST kits	
+Incentive-based strategies	Monetary or digital coupon incentives to encourage peer referral or participation in HIV testing	
+Peer-moderated online groups	Online groups moderated by peers to provide social support and encourage HIV testing uptake	
+HIVST: HIV self-testing.
+
+Theme 1: Mobile app-based strategies
+
+Mobile applications have emerged as a core digital strategy to support HIV testing, particularly among young MSM and MSM. Apps such as MyChoices, LYNX, and JomPrEP function as integrated platforms that enable users to plan testing, receive personalized reminders, access HIV self-testing kits, and utilize geolocation features to identify nearby services, thereby facilitating timely testing and linkage to care 29 , 30 , 31 , 33 , 34 , 36 , 37 . Randomized and pilot studies indicate that in-app personalization can improve adherence to recommended testing schedules, while gamification elements enhance motivation to test 30 , 31 , 34 , 36 . Clinical integration further extends functionality through e-consultation and access to results, which improves linkage to care 36 . In addition, app-based ordering of HIVST kits, digital result reporting, and pre- or post-test counselling position the app as a bridge between individuals and formal health services 29 , 30 , 31 , 33 , 34 , 36 , 37 . Considered in conjunction, mobile apps operate not only as promotional tools but also as integrated platforms that facilitate testing uptake by enabling access to HIV self-testing, providing personalized reminders, and improving linkage to care among key populations.
+
+Theme 2: Social media and web-based outreach
+
+Beyond mobile apps, social media and web platforms play a substantial role in engaging communities with HIV testing. Campaigns on platforms such as WeChat, Facebook, and Instagram have been effective in reaching key populations, as reflected in increased HIV testing uptake, engagement metrics such as click-through rates, and linkage to testing services 28 , 38 , 39 , 40 , 41 . These approaches are reinforced by interactive multimedia content, including educational videos that can increase motivation to test 28 , 29 , 41 , as well as culturally tailored content that aligns with the language and norms of target communities 42 . Click-through mechanisms route users from social media or digital adverts to dedicated landing pages where they can obtain information or order HIVST kits 28 , 32 , 42 . Paid digital advertising expands audience reach, while web-based facilitation supports kit distribution, instructions for use, and follow-up assistance 28 , 35 , 38 , 39 , 40 , 41 . In combination, social media and the web provide channels that convert information into concrete actions, contributing meaningfully to increasing HIV testing uptake.
+
+Theme 3: Digital messaging (SMS and WhatsApp)
+
+Alongside social media strategies, simple digital messaging via SMS and WhatsApp continues to be important, particularly in resource-constrained settings. A quasi-experimental study in Hong Kong found that SMS reminders significantly improved adherence to testing schedules and increased HIVST uptake in the intervention group 28 . Additional evidence from a systematic review in LMICs shows that SMS campaigns can extend the reach of HIVST interventions and are relatively easy to integrate into health systems with limited resources 39 . Their simplicity, low cost, and personal nature make SMS a reliable option for supporting reminder systems among key populations. WhatsApp also emerges as a promising medium for large-scale digital campaigns. The CHALO! 2.0 protocol in India highlights that WhatsApp Business can combine structured broadcasts, educational materials, and digital links with peer outreach, while maintaining user confidentiality 35 . Given its popularity across several middle-income countries, WhatsApp enables personal, two-way communication that complements the role of SMS in expanding HIV testing uptake.
+
+Theme 4: Peer and network-based digital strategies
+
+Beyond apps and short messaging, approaches that leverage social networks and peer support are increasingly prominent. These strategies harness interpersonal relationships to expand the reach of HIV testing. Evidence from the United States shows that peer-recruiter distribution of HIVST kits, facilitated by digital channels, reached people who rarely or never test and yielded higher positivity rates than conventional programs 27 . Other mechanisms, including digital peer recruitment and referral links, have also broadened distribution and increased community participation. For example, unique referral links combined with monetary or digital coupon incentives produced significant gains in HIVST uptake 35 , 37 . Peer-moderated online groups provide supportive social spaces for sharing experiences, offering emotional support, and reinforcing testing motivation. Studies from China and multi-country syntheses indicate that such groups can increase participation in testing 39 , 40 . In conjunction, kit distribution, digital recruitment, incentive systems, and online peer support show that peer-based strategies are relevant and effective for increasing HIV testing uptake among key populations.
+
+Overall synthesis
+
+Across the four themes, digital health promotion strategies appear complementary. Mobile apps offer integrated, personalized services; social media and web platforms broaden audience reach and convert interest into action; SMS and WhatsApp provide simple and affordable communication; and peer- and network-based strategies reinforce community engagement and the sustainability of testing behaviors. Used in combination, these approaches can address structural and social barriers while opening avenues for more contextual, scalable, and durable innovations to promote HIV testing among key populations.
+
+Discussion
+
+This scoping review highlights the diverse and complementary roles of digital health strategies in promoting HIV testing uptake among key populations. Across the included studies, app-based and social media interventions were most frequently implemented among MSM and young MSM populations, while messaging and peer-network approaches were often used to boost engagement, outreach, and HIV self-testing support across community settings. Collectively, the findings suggest that digital HIV testing promotion functions as a multidimensional ecosystem rather than a single intervention pathway, with each strategy addressing distinct structural, psychosocial, and access-related barriers to HIV testing.
+
+Mobile applications consistently emerged as a central digital innovation supporting HIV testing among key populations. Their primary advantage lies in providing flexible access to services, including ordering HIVST kits, receiving testing reminders, and accessing private digital counselling 33 , 36 . Evidence from South Africa underscores the potential of mHealth to mitigate barriers related to distance, time, and stigma, thereby driving user engagement in HIV testing 43 . Beyond access, apps build awareness and motivation through personalized reminders, integration with clinic-based services, and gamification elements 29 , 36 . Other literature notes that digital health apps can drive behavior change by improving awareness, perceived usefulness, and user satisfaction 34 , 44 . Behavioral models further suggest that perceived ease of use is positively associated with intention to undergo HIV testing 44 , 45 . These findings are consistent with trial data from the United States showing that MyChoices and LYNX increased HIV testing uptake to 74% compared with standard care 31 . Collectively, mobile apps function not only as promotional tools but also as comprehensive platforms that integrate education, motivation, and linkage to care for populations at elevated risk.
+
+While apps emphasize individualized support, social media and web platforms offer wide reach to engage key populations. Studies show that social media campaigns can recruit MSM, sex workers, and sexual minority groups with high participation, sometimes outperforming volunteer-based strategies 38 , 46 . Effectiveness is enhanced when content is culturally tailored, such as in bilingual campaigns for Latinx communities in the United States 42 , 47 . Educational internet-based and peer-delivered digital interventions have been shown to address psychosocial and motivational barriers and to increase intentions and uptake of HIV testing among key populations in diverse settings 48 . Targeted digital advertising has been reported as cost-effective in directing users to testing services, although ethical considerations remain notable 32 , 49 . Web-based facilitation further improves access to HIVST through kit-ordering pages, live-chat support, and follow-up assistance 39 , 40 . Considered in conjunction, social media and the web do not merely amplify message reach; they can convert interest into action by addressing structural, cultural, and psychosocial barriers.
+
+In combination with broad-reach strategies, simpler digital interventions such as SMS and WhatsApp remain important, particularly in resource-constrained settings. SMS reminders improved adherence to HIVST in Hong Kong 28 , and a systematic review indicates that SMS campaigns are relatively easy to integrate into health systems at low cost 39 . Additional evidence suggests high acceptability and enhanced connectedness with health services, although effects on ART and PrEP adherence vary, this broader body of evidence highlights that digital health interventions extend beyond HIV testing and also play a role in supporting adherence and retention in HIV care 50 , 51 , 52 . WhatsApp provides more interactive two-way communication. The CHALO! 2.0 protocol in India demonstrates the use of WhatsApp Business to combine multimedia messaging, educational materials, and peer outreach 35 . Evidence from South Africa indicates the feasibility of WhatsApp-based microlearning among health workers 53 . Studies in Peru and the United Kingdom also report benefits for peer support and higher engagement through online groups 54 , 55 . Given their low cost, accessibility, and personal nature, digital messaging strategies show considerable promise, despite limitations such as the relatively low interactivity of SMS, dependence on digital literacy, and privacy concerns, which may also affect access among vulnerable populations even within high-income settings 56 , 57 .
+
+Beyond apps and short messaging, approaches that mobilize social networks and peer support are increasingly prominent. These strategies leverage interpersonal ties to distribute HIVST kits, share referral links, and provide emotional support online. Randomized evidence shows that peer-led online communities can increase acceptance of HIVST among African American and Latinx MSM 58 , while a global meta-analysis reported 1.5-fold higher testing uptake among populations exposed to peer interventions compared with those unexposed 41 . Network-based kit distribution has reached more first-time testers and provided higher positivity rates than conventional methods, with indications of higher cost-effectiveness ratios 27 , 59 . The added value results from social support through motivation, positive experiences, and sustained engagement in online communities 40 , 60 , 61 . Compared with apps, SMS, or generic social media, peer and network approaches foster a stronger sense of community ownership, although they face challenges such as the need for sustained peer commitment, risks of misinformation, and data security concerns 62 . As such, these strategies are a critical complement to other digital approaches, especially for reaching high-risk groups who are difficult to engage through conventional channels; however, their effectiveness and scalability may vary across regions and health system contexts depending on differences in digital infrastructure, service integration, and the role of community-based and public health systems.
+
+Despite this review providing a comprehensive overview of digital strategies for HIV testing among key populations, several limitations should be considered. First, heterogeneity across studies in design, target populations, and outcomes limits direct comparison and generalization. Second, much of the available evidence derives from small studies, pilot trials, or protocols, which constrains the strength of conclusions and underscores the need for more robust designs. Third, geographical coverage is dominated by middle- and high-income countries, with limited representation from low-income settings, where social contexts and digital infrastructure differ markedly. Fourth, details for intervention design, including intensity, duration, and specific digital components, are not consistently reported, which complicates replication and further evaluation. Fifth, representation remains limited for certain key populations, particularly transgender women and PWID, while broader vulnerable populations, such as cisgender women and girls, were outside the predefined scope of this review. Future research should prioritize digital HIV testing interventions tailored to underrepresented populations and explore how intervention effectiveness may differ across social, cultural, structural, and health system contexts.
+
+Conclusion
+
+This scoping review mapped evidence on digital health promotion strategies designed to increase HIV testing among key populations. We identified four core themes, namely mobile applications, social media and web-based campaigns, digital messaging via SMS and WhatsApp, and peer and network-based strategies. In conjunction, these approaches constitute a complementary ecosystem, comprising from personalized service delivery to community support. The review underscores the strategic role of digital innovation in expanding access, reducing structural and psychosocial barriers, and increasing engagement in HIV testing among populations at elevated risk. From a medical practice and public health policy perspective, integrating multiple digital strategies may provide a more effective and sustainable approach, particularly in resource-constrained settings. Policymakers and healthcare professionals should consider culturally responsive and community-engaged digital interventions to improve equitable access to HIV testing among underserved populations. However, studies with more robust designs, broader geographic representation, and longer follow-up are needed to confirm effectiveness and sustainability.
+
+Data availability
+
+The sources of information used in the study are indicated in the body of the article.
+
+Supplementary Material
+
+Supplementary Material
+
+Reviewers who authorized identification: Mayara Secco Torres da Silva (0000-0002-0195-0337)
+
+Fabiane Soares (0000-0003-4067-7860)
+
+
+References
+
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+31 Biello KB Mayer KH Scott H Valente PK Hill-Rorie J Buchbinder S The effects of MyChoices and LYNX mobile apps on HIV testing and pre-exposure prophylaxis use by young US sexual minority men results from a national randomized controlled trial JMIR Public Health Surveill 2025 11 e63428 39908084 10.2196/63428 PMC11840373
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Int J Environ Res Public Health
+Journal ID: Int J Environ Res Public Health
+NLM Journal ID: 101238455
+Journal ID: ijerph
+
+International Journal of Environmental Research and Public Health
+
+ISSN: 1661-7827
+EISSN: 1660-4601
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13512571
+PMID: 42652374
+DOI: 10.3390/ijerph23081059
+Article ID: ijerph-23-01059
+Article version: 1
+Subjects: Review
+
+Mapping the Public Health Landscape in Greece: Governance, Stakeholders, Data Systems, and Policy Frameworks
+
+https://orcid.org/0000-0002-3198-3965 Triantafyllou Christos *
+https://orcid.org/0000-0003-3974-6371 Ntikoudi Anastasia
+Papachristou Anastasia
+Psiakis Vion
+Fonseca Valter R.
+https://orcid.org/0000-0002-8177-4926 Breda Joao
+Shah Gulzar H. Academic Editor
+WHO Athens Quality of Care and Patient Safety Office, 10675 Athens, Greece; ntikoudia@who.int (A.N.); papachristoua@who.int (A.P.); psiakisv@who.int (V.P.); fonsecav@who.int (V.R.F.); rodriguesdasilvabred@who.int (J.B.)
+* Correspondence: triantafyllouc@who.int
+Electronic publication date: 2026 Aug 14
+Publication date: 2026 Aug
+Volume: 23
+Issue: 8
+Electronic Location ID: 1059
+Received 2026 Jul 1; Revised 2026 Aug 13; Accepted 2026 Aug 13
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: public health, health services, community health, population health, health promotion, prevention programs, surveillance, health governance
+
+Funding: Ministry of Health of Greece This publication was funded by the Ministry of Health of Greece within the framework of the HEALTH-IQ Project, which is coordinated by the World Health Organization (WHO) Athens Quality of Care and Patient Safety Office. Its contents are the sole responsibility of the authors and do not necessarily reflect the views of the Ministry of Health of Greece. The authors affiliated with the WHO are alone responsible for the views expressed in this publication and they do not necessarily represent the decisions or policies of the WHO.
+
+Ÿ==============================Ÿ
+Highlights
+
+Public health relevance—How does this work relate to a public health issue? Greece’s public health system is undergoing major post-COVID-19 transformation, while still facing persistent challenges related to regional inequalities, workforce capacity, service organization, and access to care.
+
+This situation analysis brings together fragmented information on Greek public health governance, institutional frameworks, stakeholders, surveillance mechanisms, and available policy tools.
+
+Public health significance—Why is this work of significance to public health? The study provides a structured overview of the current public health landscape in Greece, supporting evidence-informed planning, policy coordination, and system-level reform.
+
+By mapping key actors across national, regional and local levels, the analysis highlights the importance of intersectoral collaboration for prevention, health promotion, and population health improvement.
+
+Public health implications—What are the key implications or messages for practitioners, policy makers and/or researchers in public health? Strengthening public health in Greece requires clearer governance structures, better coordination among stakeholders, and more systematic use of high-quality, interoperable data.
+
+Future public health strategies should prioritize prevention, health equity, workforce development, digital transformation and locally adapted interventions for vulnerable populations.
+
+Abstract
+
+Background: Public health in Greece has undergone substantial changes since the COVID-19 pandemic, while challenges related to governance, workforce distribution, regional inequalities and service organization remain. This study aimed to map the current public health landscape in Greece by examining its institutional frameworks, stakeholder roles, policy implementation and public health data systems. Methods: A structured situation analysis combining a review of peer-reviewed and gray literature, policy analysis, and stakeholder mapping was conducted. PubMed, EMBASE, and CINAHL were searched for English- and Greek-language publications issued between 2005 and 2026, supplemented by reports, legislation, and policy documents from the Greek Ministry of Health, the World Health Organization, the Organisation for Economic Co-operation and Development, the European Commission, and other relevant institutions. Results: Public health responsibilities were distributed across multiple national, regional, and local institutions, creating challenges concerning coordination and accountability. Regional and socioeconomic inequalities continued to affect access to services, while workforce shortages and skill-mix imbalances constrained public health capacity. Public health information was dispersed across different institutions and data systems, with limitations concerning standardization, accessibility, and interoperability. Recent legislation, prevention programs, and digital-health initiatives indicated increased policy attention to prevention and population health, although publicly available evidence regarding their implementation and outcomes remained limited. Conclusions: Strengthening public health in Greece requires clearer institutional responsibilities, improved coordination across governance levels, sustainable workforce planning and interoperable data systems that support routine monitoring of program coverage, equity, and population-level outcomes.
+
+1. Introduction
+
+Public health encompasses organized actions aimed at preventing disease, promoting health, protecting populations, and reducing avoidable inequalities. Its effective operation depends on coherent governance, intersectoral coordination, an appropriately skilled workforce, epidemiological surveillance, and the systematic use of reliable data [1,2,3,4,5,6]. These functions are particularly important in health systems facing demographic aging, chronic disease, emerging health threats, and unequal distribution of services.
+
+In Greece, public health has been shaped by prolonged economic pressures, population aging, workforce shortages, regional disparities, and socioeconomic inequalities [7]. The COVID-19 pandemic further highlighted the importance of preparedness, surveillance, health communication, digital infrastructure, and coordination across national, regional, and local levels [8,9]. In response, recent reforms have increased policy attention to prevention, health promotion, screening, and digital transformation. Nevertheless, public health responsibilities remain distributed across multiple institutions, while relevant information is dispersed across legislation, institutional reports, academic studies, and separate data systems.
+
+Existing studies and reports have generally examined individual components of the Greek public health and healthcare system, including access, primary care, workforce capacity, regional inequalities, and specific prevention initiatives. However, an integrated analysis of current governance arrangements, stakeholder responsibilities, policy frameworks, public health activities, and available data systems remains limited.
+
+This study aimed to map the current public health landscape in Greece by examining its governance arrangements, principal stakeholders, legal and policy frameworks, public health activities, and available data systems. Specifically, it addressed the following questions: how are public health responsibilities distributed across national, regional, and local levels; which institutions contribute to policymaking, regulation, surveillance, financing, service delivery, research and advocacy; which policy frameworks and data systems support public health action; and which organizational, workforce, access, and data-related challenges are identified in the available evidence? As the study does not apply predefined indicators, benchmarks, or comparative criteria, it is presented as a situation analysis rather than a formal assessment of system performance.
+
+2. Materials and Methods
+
+2.1. Study Design and Analytical Framework
+
+This study was conducted as a structured situation analysis of the public health landscape in Greece. It combined a purposive review of peer-reviewed and gray literature with policy and documentary analysis and stakeholder mapping. The study was not designed as a systematic or scoping review and did not aim to identify exhaustively all publications related to public health in Greece. Rather, it sought to integrate the most relevant and current evidence required to describe public health governance, institutional responsibilities, policy frameworks, service organization, workforce capacity, access and equity, prevention and health promotion, epidemiological surveillance, digital transformation, and public health data systems.
+
+The analytical domains were informed by the WHO essential public health functions [2,3] and adapted to the objectives of the present situation analysis. Evidence was organized across the following domains: governance and legislation; institutional and stakeholder responsibilities; public health financing and service organization; workforce capacity; access and equity; prevention and health promotion; surveillance and preparedness; digital infrastructure; and data availability, accessibility, and interoperability.
+
+2.2. Information Sources and Search Strategy
+
+The original search was undertaken between August and September 2025 and was updated on 30 June 2026. PubMed, EMBASE, and CINAHL were searched for English- and Greek-language sources published between January 2005 and April 2026. The search combined country-related terms with terms corresponding to the predefined analytical domains. The principal search terms included “Greece”, “Greek”, “public health”, “health services”, “health governance”, “health policy”, “primary healthcare”, “health workforce”, “health inequalities”, “health promotion”, “prevention programmes”, “epidemiological surveillance”, “digital health”, “health information systems”, “stakeholders”, “data systems” and “interoperability”. Database-specific subject headings, including MeSH terms in PubMed, were combined with free-text title and abstract terms using the Boolean operators AND and OR.
+
+Targeted searches were also conducted on the websites and document repositories of relevant Greek and international institutions. These included the Greek Ministry of Health, the National Public Health Organization, the Hellenic Statistical Authority (ELSTAT), the Ministry of Interior, the National Organization for the Provision of Health Services, the Agency for Quality Assurance in Health, e-Government Center for Social Security (IDIKA), the World Health Organization, the European Observatory on Health Systems and Policies, the Organisation for Economic Co-operation and Development and the European Commission. The gray-literature search included legislation, national strategies, policy documents, institutional and administrative reports, surveillance reports, official statistical information, and relevant institutional webpages. Reference lists of key academic and institutional sources were also examined to identify additional material.
+
+2.3. Eligibility Criteria and Source Selection
+
+Sources were considered eligible when they addressed at least one system-level aspect of public health in Greece. Eligible topics included public health governance and legislation; institutional and stakeholder responsibilities; service organization and financing; public health and primary healthcare workforce capacity; prevention and health-promotion policies; epidemiological surveillance and preparedness; regional, geographical, or socioeconomic inequalities; digital-health infrastructure; health information systems; data governance; and intersectoral collaboration.
+
+Peer-reviewed publications, legislation, strategic plans, policy documents, official reports, and other relevant institutional sources were eligible for inclusion. Sources focusing exclusively on clinical management or disease-specific treatment without relevance to public health organization, governance or policy were excluded. Documents that had been superseded by more recent legislation or policy frameworks were excluded unless they were required to describe the historical development of the system. Sources outside the specified publication period, languages, or geographical scope were also excluded. Source screening and eligibility assessment were undertaken by A.N. and A.P. Potentially eligible or uncertain sources were reviewed jointly, and final inclusion or exclusion decisions were reached through discussion and consensus.
+
+2.4. Data Extraction and Source Appraisal
+
+Evidence relevant to the study objectives was identified within the included sources and integrated into the narrative analysis. Information from peer-reviewed publications, legislation, policy documents, institutional reports, and official webpages was compared to identify areas of agreement, inconsistency, and limited or missing evidence. Data extraction was undertaken by A.N. and A.P. Extracted information was checked against the original sources, and any discrepancies or uncertainties were resolved through discussion and consensus.
+
+Given the heterogeneity of the included source types, no single formal risk-of-bias or standardized quality-assessment instrument was considered applicable. Sources were not assigned numerical quality scores. Their credibility and relevance were considered according to the authority of the issuing organization, recency, methodological transparency, relevance to the study objectives, and consistency with other available evidence. Greater interpretive weight was given to current legislation, official national and international institutional documents, and peer-reviewed publications with clearly reported methods. The absence of a formal quality-appraisal procedure was acknowledged as a methodological limitation.
+
+2.5. Stakeholder Identification and Mapping
+
+Stakeholders were identified from legislation, official organizational information, policy documents, institutional reports, and relevant academic literature. Inclusion was based on a documented role in the organization, regulation, coordination, financing, surveillance, delivery, or support of public health activities in Greece.
+
+The identified stakeholders were described according to their level of operation and broad institutional role. These included national government and regulatory bodies, regional and local authorities, healthcare organizations, academic and research institutions, and civil-society and patient organizations. The analysis focused on their formally assigned responsibilities, their contribution to public health activities, and the main areas in which coordination with other organizations was required. The stakeholder mapping was descriptive and did not involve formal scoring, network analysis, or ranking of stakeholder influence.
+
+2.6. Data Synthesis
+
+Owing to the heterogeneity of the evidence included, statistical pooling was neither appropriate nor undertaken. The findings were synthesized using a narrative thematic approach. Evidence was compared across source types and organized under the predefined analytical domains. Where academic publications, legislation, and institutional sources provided different or potentially conflicting accounts, these differences were retained and examined rather than resolved solely through author interpretation. Areas for which current, consistent, or publicly accessible evidence was unavailable were explicitly identified as evidence gaps.
+
+The overall analytical process comprised source identification, duplicate removal, relevance assessment, detailed eligibility assessment, source appraisal, data extraction, stakeholder classification, and narrative thematic synthesis. This process is presented in Figure 1 using an adapted PRISMA-style format to improve reporting transparency.
+
+3. Results
+
+3.1. Current Status of Public Health Activities and Policies in Greece
+
+3.1.1. Cultural, Behavioral, and Societal Factors
+
+Recent developments indicate increased policy attention to prevention, health promotion, screening, epidemiological preparedness, and digital health in Greece. However, the available evidence does not demonstrate a completed system-wide transition or uniform improvements across regions and population groups. The current public health landscape is therefore better characterized as one of ongoing reform, alongside persistent challenges related to resource allocation, workforce capacity, access inequalities, institutional coordination, and data fragmentation. The following subsections present the principal developments and remaining system-level challenges identified in the reviewed evidence.
+
+3.1.2. Resource Allocation
+
+Resource allocation and funding for public health services continue to pose challenges in Greece. During the economic crisis of the early 2010s, austerity measures and reductions in public expenditure affected the capacity of the wider healthcare system [10]. Budgetary constraints have limited the resources available for public health programs and may influence the continuity and geographical consistency of preventive and health-promotion services [11]. Recent reforms have strengthened the policy focus on prevention and the more strategic use of available resources, providing a more supportive foundation for the expansion of public health programs and more balanced service provision across regions and population groups. Continued monitoring of expenditure, program coverage, and regional resource allocation is therefore required.
+
+3.1.3. Workforce Development
+
+The healthcare system in Greece has faced challenges related to capacity, staffing, and the availability of resources [7]. Major challenges are: (a) the number of healthcare workers, especially when it comes to nurses and the ratio of generalists to specialist physicians, and (b) skills that are necessary in the modern context of the provision of public health services, from planning to delivery [7]. Recent initiatives have placed greater emphasis on workforce planning, professional training, primary healthcare teams, health promotion, and disease prevention [11]. These developments indicate increasing recognition of the competencies required for public health delivery, although workforce shortages and skill-mix imbalances remain important challenges.
+
+3.1.4. Regional Disparities
+
+The distribution of public health services in Greece is quite uneven, with urban areas often having better access to specialized care than rural regions [12]. Promising initiatives regarding decentralization of public health services have been introduced in order to improve access to healthcare services in distant and island areas [12]. Community-based interventions, mobile health services, and telemedicine programs have been introduced as mechanisms for improving access in rural, remote, and island areas, although their coverage and effect on regional inequalities require continued evaluation [13].
+
+3.1.5. Socioeconomic Inequalities
+
+Many differences are observed in parts of the population regarding socioeconomic factors. Income inequality is above the EU average, and there are marked differences in terms of access to services or access to information [14]. The Greek authorities work on reducing socioeconomic disparities by providing healthcare services to all citizens regardless of their financial or social insurance status. Recent reforms and outreach initiatives have increased policy attention to the needs of vulnerable populations, including access to health information and preventive services. Nevertheless, socioeconomic inequalities continue to affect effective access to healthcare and public health interventions.
+
+3.1.6. Demographic Factors
+
+Greece has an aging population, leading to an increased demand for healthcare services, long-term care, and management of chronic conditions. Projections indicate that by 2050, more than a third of the Greek population will be older than 65 years, with nearly 13% older than 80 years [15]. Addressing the specific health needs of the elderly presents challenges for the healthcare system [7]. The public sector cooperates with municipalities and other civil society organizations in order to deliver home-based care services, supporting in this way healthy aging and chronic disease management [11].
+
+3.1.7. Refugee and Migrant Health
+
+The country has faced various challenges in addressing the health needs of refugees and migrants. Issues include access to healthcare services, communicable disease control, and the integration of diverse populations into the healthcare system [16]. During the past decade, the public health response has increasingly involved collaboration with non-governmental and international organizations providing culturally appropriate healthcare, vaccination, and disease-prevention services [16].
+
+Addressing these challenges requires a comprehensive and coordinated approach involving government agencies, healthcare providers, communities, and international collaborations. Continued investment in public health infrastructure, workforce development, and evidence-based policies is crucial to overcoming these barriers.
+
+3.2. Stakeholders
+
+3.2.1. Public Health Stakeholders in Greece
+
+Public health governance in Greece involves institutions operating at national, regional, and local levels. These include the Ministry of Health and its supervised agencies, the Health Regions, regional and municipal authorities, healthcare providers, academic and research institutions, professional organizations, patient associations, and civil-society organizations. Their responsibilities include policymaking, regulation, epidemiological surveillance, health-service administration, quality assurance, data management, research, health promotion, and advocacy. Table 1 summarizes the principal stakeholders, their level of operation, main responsibilities, and institutional relationships.
+
+3.2.2. Ministry of Health
+
+The Ministry of Health is the principal national authority responsible for the formulation, implementation, and supervision of health and public health policy in Greece. Through the General Secretariat for Public Health and the General Directorate of Public Health and Quality of Life, it coordinates activities related to disease prevention, health promotion, communicable and non-communicable disease control, environmental health, public health inspections, addictions, and emergency preparedness [17]. The Ministry also oversees the wider organization of healthcare services, regulates professional and institutional standards, and supervises national agencies and Health Regions involved in public health and healthcare delivery. Because many determinants of health extend beyond the healthcare sector, the Ministry collaborates with other ministries, regional and municipal authorities, public organizations, healthcare providers, and international institutions. This coordinating role is particularly important for ensuring alignment between national policy priorities and their implementation across different levels of governance.
+
+3.2.3. Regional Level-DYPE
+
+The regional organization of health and public health services in Greece has developed through successive legislative reforms. Laws 2503/1997 and 2519/1997 provided an early framework for the organization of regional administration and public health services, including regional responsibilities for prevention, health promotion, and the protection of population health [18,19]. Greece is currently divided into seven Health Regions, which operate as public-law entities under the supervision of the Ministry of Health and are responsible for the planning, coordination, supervision, and monitoring of healthcare organizations within their respective geographical jurisdictions [20]. The current composition and geographical jurisdiction of the seven Health Regions were specified through the replacement of Article 1 of Law 3329/2005 by Article 27 of Law 4771/2021 [20]. Health Regions constitute sector-specific health-administration bodies and should be distinguished from the country’s administrative regions, which form part of the local-government structure and exercise separate public health responsibilities.
+
+3.2.4. First and Second Levels of Local Government
+
+Public health responsibilities at the subnational level are exercised through the two levels of local government: municipalities at the first level and the 13 administrative regions at the second level. The former prefectural administrations no longer constitute an independent level of government; their functions were transferred mainly to the regions and municipalities, while regional units now operate as territorial subdivisions of the administrative regions. Law 3370/2005 provided an earlier framework for the organization and coordination of public health services and their relationships with central and regional authorities [21]. The current local-government structure is governed by the Local Government Code introduced by Law 5314/2026 [22], building on the administrative reforms established through Law 3852/2010 [23]. Regional and municipal authorities exercise public health-related responsibilities according to their statutory competence, including environmental health, sanitary controls, prevention and health promotion, community services, and locally implemented public health activities. These responsibilities require coordination with the Ministry of Health, the Health Regions, the National Public Health Organization, and other competent bodies.
+
+3.2.5. Regional and Local Public Health Responsibilities
+
+Greece’s subnational administrative structure comprises 13 administrative regions and municipalities, while regional units operate as territorial subdivisions of the regions. Following the administrative reform introduced by Law 3852/2010, the former prefectural administrations ceased to constitute a separate level of local government, and their institutions and responsibilities were transferred principally to the regions and municipalities [24]. Competent regional and municipal services exercise public health-related responsibilities that include the enforcement of health regulations, sanitary inspections, monitoring of water and food safety, and the licensing or supervision of establishments of public health relevance. These functions are undertaken within the statutory responsibilities of each authority and in coordination with the competent national and health-sector institutions.
+
+Public health services of the administrative regions and municipalities contribute, within their statutory responsibilities, to vaccination activities, communicable-disease notification and surveillance, epidemiological investigation, health education, disease prevention, and health-promotion measures. These functions are implemented in coordination with the Ministry of Health, the National Public Health Organization, the Health Regions and healthcare providers [21,25].
+
+The oversight of both public and private health services, including clinics, laboratories, pharmacies, dentists, physiotherapists, and various health-related professions such as psychologists, nurses, dental technicians, beauticians, opticians, hairdressers, and slimming centers, falls within the responsibilities of the competent regional health and public health authorities. These authorities hold the legal and institutional authority to regulate and register these professions, granting professional licenses, licenses for the establishment and operation of professional units, and certificates of good functioning, among other responsibilities [25].
+
+The Greek healthcare system consists of primary healthcare centers and secondary and tertiary hospitals, which provide both prevention and care services. The delivery of the first-line public health services depends mainly on specialized healthcare professionals (community nurses, general practitioners, and health visitors) who facilitate public health promotion activities, perform screenings in the general population and vaccination campaigns, and deliver community health interventions [25].
+
+3.3. Other Public Health Stakeholders and Supporting Agencies
+
+At the national level, the National Organization for the Provision of Health Services (EOPYY) purchases, contracts, and reimburses publicly funded healthcare services; the Agency for Quality Assurance in Health (ODIPY S.A.) supports quality assurance and patient safety; and the National Evaluation Center of Quality and Technology in Health (EKAPTY) evaluates and certifies quality-management systems and medical devices in the health sector (Table 1).
+
+Non-governmental organizations, in conjunction with patient advocacy groups, play a crucial role as essential components of the promotion of public health. The Patients’ Alliance, the Hellenic Cancer Federation (ELLOK) and the Forum for Public Health are entities whose purpose is to raise awareness and deliver patient support services while advocating patients’ rights.
+
+Academic institutions and research organizations are important contributors to public health initiatives through not only their curriculum regarding public health awareness and education but also through their research work. These institutions provide scientifically substantiated evidence for policy-making purposes and contribute significantly to shaping future public health specialists.
+
+The stakeholders described above contribute to public health policy, service delivery, research, quality improvement, advocacy, and community support. Effective implementation requires coordination among governmental bodies, healthcare organizations, academic institutions, professional organizations, and civil-society actors, with clearly defined responsibilities and communication mechanisms across national, regional, and local levels.
+
+3.4. Frameworks
+
+Legal and Regulatory Framework
+
+A series of legislative efforts for the regulation of the field of public health has taken place from 2000 onwards. The main text currently regulating the field of public health in Greece (Law 4675/2020) was voted and implemented in an effort to highlight the role of public health, reduce overlap between the different bodies and institutions, and align the country with the international setting of public health [25]. The law defines (1) terms related to public health (e.g., specifies public health policies) and (2) actions that can be taken by the state in order to compile and implement those policies. Such actions include (a) the design, assessment, and socio-economic evaluation of healthcare programs and interventions, (b) the management and control of social, behavioral, and environmental risk factors for health, as well as those arising from climate change and the migration of large segments of the population. The law specifically links public health actions with primary health care, at the community level [23].
+
+The National Action Plan for Public Health 2021–2025 [26,27] introduced priorities related to prevention programs, screening interventions, digital health transformation, and intersectoral public health governance. Additional national initiatives, including quality improvement and digital health strategies, further support the modernization and coordination of public health services in Greece.
+
+Recent national prevention initiatives, including the ‘Spyros Doxiadis’ program, have further strengthened the implementation of primary, secondary, and tertiary prevention policies in Greece through population-based screening, health promotion, and early intervention strategies [28].
+
+Furthermore, public health reforms in Greece have also emphasized digital transformation through the expansion of electronic health records, telehealth, and teleconsultation services, as well as digital epidemiological surveillance systems aimed at improving healthcare coordination and evidence-informed decision-making [29].
+
+3.5. Available Public Health Data Systems and Metrics
+
+Public health information in Greece is generated through statistical, epidemiological, clinical, and administrative data systems managed by different institutions. The Hellenic Statistical Authority (ELSTAT) produces population-level information through the Health Interview Survey and other official health-statistics collections. The 2019 Health Interview Survey provides published national results, while ELSTAT also permits access to anonymized public-use and scientific-use microdata, including National Health Survey and mortality data, through established registration, application, and approval procedures [30,31]. These sources are updated according to the schedule of each survey or statistical series and primarily support population-level analysis and national and international comparisons rather than real-time surveillance.
+
+The National Public Health Organization (EODY) operates the mandatory notification system and other disease-specific epidemiological-surveillance mechanisms. Notifications submitted by healthcare facilities are received, recorded, and analyzed by the competent EODY directorates and are used to support public health interventions [32]. The system is updated as notifications are submitted, according to the reporting requirements and deadlines applicable to each notifiable disease. Access to identifiable case-level information is restricted, while aggregate findings are disseminated through epidemiological reports. The completeness and timeliness of the data depend partly on reporting by healthcare facilities and professionals.
+
+IDIKA S.A. operates important components of the national digital-health infrastructure, including electronic prescribing and the National Electronic Health Record. Electronic-prescribing data are generated and updated through the routine issue and execution of prescriptions [33]. The National Electronic Health Record is designed to integrate information from electronic prescribing, primary healthcare, hospitals, diagnostic centers, patient registries, and EOPYY [34]. Its national implementation through the MyHealth platform version 2.12.32 commenced in 2025, providing citizens and authorized healthcare professionals with access to integrated health information [35].
+
+EOPYY generates administrative and reimbursement data through its purchasing and contracting functions. Its Health Insurance Record contains information on hospitalizations, healthcare services, medical materials, diseases, and diagnoses, derived from information submitted by healthcare providers and insured persons for the reimbursement of healthcare benefits [36]. These records are updated through routine service and reimbursement submissions and cover a substantial proportion of the insured population. Individual insured persons may access their own records, but the source does not indicate general public access to record-level data for research or population-health monitoring. Because these data are collected primarily for administrative and reimbursement purposes, their secondary use for epidemiological analysis requires appropriate validation and standardized coding.
+
+Overall, Greece has several data systems with broad population and service coverage, but these systems differ in purpose, update frequency, accessibility, and data structure. The National eHealth Interoperability Framework and the National Electronic Health Record represent important developments towards more standardized data exchange and integration [34,35,37]. Nevertheless, the reviewed public sources do not provide a single cross-system assessment of data completeness, coding consistency, linkage quality, and interoperability. These dimensions should therefore be considered when statistical, surveillance, clinical, and reimbursement data are reused for program evaluation, research, and public health decision-making.
+
+4. Discussion
+
+The findings indicate that Greece has increased policy attention to prevention, digital health and public health coordination, but the available evidence does not yet demonstrate uniform implementation or measurable improvement across all regions and population groups. This interpretation is consistent with the latest Greek Country Health Profile, which identifies continuing pressures related to service delivery, workforce capacity, infrastructure, preparedness, digital transformation, and long-term system sustainability [38]. Similar challenges are reported in other Southern European health systems, although their governance arrangements differ. Spain operates a highly decentralized system in which regional authorities hold substantial responsibility for service organization and delivery, supported by national coordination through the Interterritorial Council [39]. Portugal has pursued stronger central management while simultaneously expanding primary and integrated care [40]. These comparisons suggest that the involvement of multiple administrative levels does not necessarily result in fragmentation; the critical factors are the clarity of institutional responsibilities, effective coordination mechanisms, accountability, and the capacity to share and use information across organizations.
+
+Management of chronic diseases is another factor that plays an important role in the Greek public health governance [41]. The following years require targeted health policy planning focused on the prevention and management of chronic diseases, long-term care, and community-based services, as the population changes over the years have led to increased requirements for improved public health initiatives [41].
+
+The digital transformation of the Greek healthcare system creates not only new opportunities but major challenges for public health services [42]. The implementation of digital tools such as electronic health records, telehealth/teleconsultations, and digital epidemiological surveillance systems provides additional resources to healthcare governance in order to improve the operational performance and data-oriented decision-making [42].
+
+The Greek public health sector has undergone important reforms in recent years; however, challenges related to institutional coordination, workforce capacity, and consistency in service delivery remain [42]. Against this background, the HEALTH-IQ project represents one of the current national efforts to strengthen quality of care and patient safety. Coordinated by the WHO Athens Quality of Care and Patient Safety Office in collaboration with the Greek Ministry of Health, the project aims to support the development of a more standardized quality framework across health services [43,44]. At the time of this analysis, publicly available information focused mainly on the project’s objectives, governance arrangements, and planned activities, while independent evidence regarding its outcomes and system-level impact remained limited. HEALTH-IQ should therefore be understood as an ongoing policy and implementation initiative rather than as evidence of demonstrated improvement.
+
+Standardization of data poses a major obstacle in the field of public health. The evaluation of public health policies and evidence-based decision-making depends mainly on the availability of high-quality data, which must be timely and comparable. The implementation of public health initiatives requires ongoing interdisciplinary teamwork among healthcare professionals and epidemiology experts [45,46].
+
+Public health services need to be defined by cultural competence and participatory methods in order to design and implement programs which meet the population’s needs, including marginalized groups [47]. Public health strategies need to be adaptive and evidence-based to be able to handle emerging health threats, including pandemics and climate-related emergencies [47]. The public healthcare workforce requires specialized professionals in public health, epidemiology, and health promotion in order to maintain high-quality health services in the Greek population [48].
+
+This study has several strengths and limitations. Its principal strength is the integration of peer-reviewed literature, legislation, policy documents, institutional reports, and stakeholder information within a common analytical framework, providing a broad overview of public health governance and data systems in Greece. However, the purposive rather than exhaustive selection of sources may have introduced selection bias, particularly where relevant documents were not publicly accessible or were not identified through the selected databases and institutional websites. The substantial contribution of gray literature was necessary because many governance and policy developments are documented primarily in legislation and institutional publications; nevertheless, these sources vary in methodological transparency and may reflect the priorities of the organizations that produced them. No formal quality-assessment tool or numerical weighting system was applied because of the heterogeneity of the included evidence, which limits the ability to compare the methodological strength of individual sources. In addition, the rapidly changing legislative, organizational, and digital-health environment means that some findings may become outdated as reforms progress. The results should therefore be interpreted as a structured account of the evidence available during the review period rather than as a definitive evaluation of current system performance.
+
+5. Conclusions
+
+Based on the evidence reviewed, Greece appears to be moving towards a more prevention-oriented, digitally supported, and coordinated approach to public health, while important challenges remain in governance, workforce capacity, regional equity and data interoperability. Recent reforms and initiatives provide opportunities for further system strengthening, but their implementation, coverage and outcomes require continued and independent evaluation. Future progress will depend on sustainable resource allocation, clearer institutional responsibilities, effective coordination across governance levels and the routine use of comparable public health data. The findings should therefore be interpreted as a current mapping of policy and system developments rather than as evidence that a comprehensive and equitable public health system has already been achieved.
+
+Acknowledgments
+
+During the preparation of this manuscript, the authors used Zotero version 9 for the purposes of bibliography input. The authors have reviewed and edited the output and take full responsibility for the content of this publication.
+
+Author Contributions
+
+Conceptualization, J.B. and C.T.; methodology, C.T., V.R.F. and J.B.; validation, C.T., V.R.F. and J.B.; formal analysis, A.N.; investigation, A.N. and A.P.; resources, V.P.; data curation, A.N. and A.P.; writing—original draft preparation, A.N. and A.P.; writing—review and editing, C.T. and V.R.F.; supervision, J.B. and V.R.F.; project administration, C.T.; funding acquisition, V.P. All authors have read and agreed to the published version of the manuscript.
+
+Institutional Review Board Statement
+
+Not applicable.
+
+Informed Consent Statement
+
+Not applicable.
+
+Data Availability Statement
+
+No new data were created or analyzed in this study. Data sharing is not applicable to this article.
+
+Conflicts of Interest
+
+The authors affiliated with the World Health Organization are solely responsible for the views expressed in this publication, which do not necessarily represent the decisions or policies of the WHO.
+
+Abbreviations
+
+The following abbreviations are used in this manuscript: DYPE	Regional Health Authorities/Health Regions	
+EKAPTY	National Evaluation Center of Quality and Technology in Health	
+ELLOK	Hellenic Cancer Federation	
+EOPYY	National Organization for the Provision of Health Services	
+EU	European Union	
+HEALTH-IQ	Health Information Quality Project	
+NGOs	Non-governmental organizations	
+OECD	Organisation for Economic Co-operation and Development	
+ODIPY S.A.	Agency for Quality Assurance in Health S.A.	
+OTA	Local Government Authorities	
+WHO	World Health Organization	
+YPE	Regional Health Authorities/Health Regions	
+
+Figure 1 Flow of source identification and selection for the situation analysis.
+
+ijerph-23-01059-t001_Table 1 Table 1 Principal stakeholders in the Greek public health system.
+
+Stakeholder	Governance Level	Main Role and Authority	Main Institutional Relationships	
+Ministry of Health	National	Develops and supervises health and public health policy, legislation, regulation and strategic planning	Supervises national agencies and Health Regions and coordinates with other ministries and international organizations	
+National Public Health Organization	National	Epidemiological surveillance, disease prevention, risk assessment, preparedness and outbreak response	Cooperates with the Ministry of Health, Health Regions, laboratories and healthcare providers	
+Health Regions (YPE/DYPE)	Regional health administration	Plan, coordinate, supervise and monitor healthcare organizations within their jurisdictions	Operate under the Ministry of Health and coordinate hospitals, health centers and primary healthcare services	
+Administrative regions and municipalities	Regional and local government	Environmental health, sanitary controls, health promotion, prevention and community services	Cooperate with the Ministry of Health, Health Regions, national agencies and local providers	
+EOPYY	National	Purchases, contracts and reimburses publicly funded healthcare services	Cooperates with the Ministry, public and private providers and national digital systems	
+ODIPY S.A.	National	Supports quality assurance, quality improvement and patient safety	Cooperates with the Ministry, Health Regions and healthcare organizations	
+EKAPTY	National	Supports quality evaluation and certification activities in the health sector	Cooperates with health authorities, providers and relevant regulatory bodies	
+Academic and research institutions	National and regional	Research, evidence generation, education and workforce development	Cooperate with public authorities, healthcare organizations and research networks	
+Patient and civil-society organizations	National and local	Advocacy, patient representation, public information and community support	Cooperate with policymakers, providers, researchers and local communities	
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
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+31. Hellenic Statistical Authority Microdata of Statistical Surveys Hellenic Statistical Authority Piraeus, Greece 2016 Available online: https://www.statistics.gr/en/micro-data (accessed on 30 July 2026)
+32. National Public Health Organization Mandatory Notification System National Public Health Organization Athens, Greece 2024 Available online: https://eody.gov.gr/el/symvanta-dimosias-ygeias/epidimiologiki-epitirisi/systimata-epitirisis/systima-ypoxreotikis-dilosis.html (accessed on 30 July 2026)
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+35. Ministry of Health of Greece Launch of the Universal Implementation of the New NHS Digital Platform for the National Electronic Health Record Ministry of Health of Greece Athens, Greece 2025 Available online: https://www.moh.gov.gr/articles/ministry/grafeio-typoy/press-releases/13365-enarksh-katholikhs-efarmoghs-ths-neas-pshfiakhs-platformas-toy-esy-gia-ton-ethniko-hlektroniko-fakelo-ygeias-ehfy (accessed on 30 July 2026)
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+37. Ministry of Health of Greece Design and Implementation of the Greek National eHealth Interoperability Framework (NeHIF) Ministry of Health of Greece Athens, Greece 2020 Available online: https://www.moh.gov.gr/articles/ehealth/6765-design-and-implementation-of-the-greek-national-ehealth-interoperability-framework-nehif (accessed on 30 July 2026)
+38. OECD and European Observatory on Health Systems and Policies Greece: Country Health Profile 2025 State of Health in the EU OECD Publishing and European Observatory on Health Systems and Policies Paris, France Brussels, Belgium 2025
+39. Bernal-Delgado E. Angulo-Pueyo E. Ridao-López M. Urbanos-Garrido R.M. Oliva-Moreno J. García-Abiétar D. Hernández-Quevedo C. Spain: Health System Summary European Observatory on Health Systems and Policies, WHO Regional Office for Europe Copenhagen, Denmark 2024 40094303
+40. Fronteira I. Augusto G.F. Maresso A. Portugal: Health System Summary, 2024 European Observatory on Health Systems and Policies, WHO Regional Office for Europe Copenhagen, Denmark 2025
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+42. Flokou A. Aletras V. Miltiadis C. Karaferis D. Niakas D. Efficiency of primary health services in the Greek public sector: Evidence from bootstrapped DEA/FDH estimators Healthcare 2024 12 2230 10.3390/healthcare12222230 39595428 PMC11593388
+43. Launch of the HEALTH-IQ Project in Greece: Improving Quality of Care Across the WHO European Region [Internet] Available online: https://www.who.int/europe/news-room/events/item/2024/02/16/default-calendar/launch-of-the-health-iq-project-in-greece--improving-quality-of-care-across-the-who-european-region (accessed on 20 January 2026)
+44. Ministry of Health National Strategy for Quality of Care and Patient Safety for Greece 2025–2030 Ministry of Health Athens, Greece 2025
+45. Stubbe D.E. Practicing Cultural Competence and Cultural Humility in the Care of Diverse Patients Focus J. Lifelong Learn. Psychiatry 2020 18 49 51 10.1176/appi.focus.20190041 32047398 PMC7011228
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+47. Khalil H. Marcucci J. Liu C. Leveraging new methodologies for public health crisis management Front. Public Health 2024 12 1508417 10.3389/fpubh.2024.1508417 39758199 PMC11695333
+48. Spanakis M. Stamou M. Boultadaki S. Liantis E. Lionis C. Marinos G. Mariolis A. Matthaiou A.M. Mihas C. Mouchtouri V. Enhancing Competencies and Professional Upskilling of Mobile Healthcare Unit Personnel at the Hellenic National Public Health Organization Healthcare 2025 13 1706 10.3390/healthcare13141706 40724731 PMC12296029
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12124545
+PMID: 40446001
+DOI: 10.1371/journal.pone.0325455
+Article ID: PONE-D-24-16907
+Article version: 1
+Subjects: Research Article, Medicine and Health Sciences, Health Care, Caregivers, Biology and Life Sciences, Organisms, Eukaryota, Animals, Pets and Companion Animals, Biology and Life Sciences, Zoology, Animals, Pets and Companion Animals, Medicine and Health Sciences, Epidemiology, Medical Risk Factors, People and Places, Population Groupings, Professions, Veterinarians, Biology and Life Sciences, Veterinary Science, Veterinary Diseases, Biology and Life Sciences, Immunology, Vaccination and Immunization, Medicine and Health Sciences, Immunology, Vaccination and Immunization, Medicine and Health Sciences, Public and Occupational Health, Preventive Medicine, Vaccination and Immunization, Medicine and Health Sciences, Medical Conditions, Tropical Diseases, Neglected Tropical Diseases, Rabies, Medicine and Health Sciences, Medical Conditions, Infectious Diseases, Viral Diseases, Rabies, Medicine and Health Sciences, Medical Conditions, Infectious Diseases, Zoonoses, Rabies, Biology and Life Sciences, Organisms, Eukaryota, Animals, Vertebrates, Amniotes, Mammals, Dogs, Biology and Life Sciences, Zoology, Animals, Vertebrates, Amniotes, Mammals, Dogs
+
+Risk factors for, metrics of, and consequences of access to veterinary care for companion animals: A scoping review
+
+Scoping review A2VC
+
+https://orcid.org/0000-0003-0604-7822 O’Connor Annette Conceptualization Data curation Formal analysis Investigation Methodology Project administration Supervision Visualization Writing – original draft Writing – review & editing 1 *
+https://orcid.org/0000-0003-2624-9405 Totton Sarah Ceridwen Data curation Formal analysis Investigation Methodology Supervision Visualization Writing – original draft Writing – review & editing 2
+Hernandez Michelle Data curation Writing – original draft Writing – review & editing 1
+Meyers Emily Data curation Formal analysis Writing – original draft Writing – review & editing 1
+Meyers Kelley Conceptualization Writing – review & editing 3
+https://orcid.org/0009-0005-0998-1890 Abreu Hilda Mejia Conceptualization Formal analysis Funding acquisition Writing – review & editing 3
+Spofford Nathaniel Conceptualization Formal analysis Writing – review & editing 4
+Morrison JoAnn Conceptualization Formal analysis Writing – review & editing 4
+1 Department of Large Animal Clinical Sciences, College of Veterinary Medicine, Michigan State University, East Lansing, Michigan, United States of America
+2 Private Consultant, Guelph, Ontario, Canada
+3 Michigan State University Veterinary Medical Center, Michigan State University, East Lansing, Michigan, United States of America
+4 Mars Veterinary Health, Vancouver, Washington, United States of Amierica
+Pilotte Nils Editor
+Quinnipiac University, UNITED STATES OF AMERICA
+Competing Interests: The authors have declared that no competing interests exist.
+
+* E-mail: oconn445@msu.edu
+Electronic publication date: 2025 May 30
+Publication date: 2025
+Volume: 20
+Issue: 5
+Electronic Location ID: e0325455
+Received 2024 Apr 26; Accepted 2025 May 12
+Copyright: © 2025 O’Connor et al
+Copyright year: 2025
+Copyright holder: O’Connor et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum in: Correction: Risk factors for, metrics of, and consequences of access to veterinary care for companion animals: A scoping review 20 9 23 9 2025 e0333116 PLOS One 10.1371/journal.pone.0333116 PMC12456816 40986473
+
+Funding: King-Chavez-Parks (KCP) Select Student Support Services (4S) grant N/A Meyers Emily King-Chavez-Parks (KCP) Select Student Support Services (4S) grant N/A Hernandez Michelle MH and EM were supported by the King Chavez Parks Select Student Support Services grant from the state of Michigan (https://www.michigan.gov/leo/bureaus-agencies/wd/education-training/kcp). The grant supports pathway development and nurtures pre-veterinary students to explore different options in veterinary medicine. The funder did not have a role in study design, data collection, data analysis, decision to publish, or preparation of the manuscript.
+
+Figure count: 1
+Table count: 7
+Page count: 15
+Data Availability: All relevant data are within the manuscript and its Supporting information files.
+
+Data Availability
+
+All relevant data are within the manuscript and its Supporting information files.
+
+Ÿ==============================Ÿ
+Background
+
+Barriers to accessing veterinary care can be challenging for companion-animal caregivers and may lead to preventable health conditions or even death of pets.
+
+Objectives
+
+We conducted a scoping review to: 1) catalog the definitions of access to veterinary care (A2VC) used by researchers, 2) identify risk factors for and consequences of A2VC, and 3) map the risk factors onto dimensions of access to care (affordability, availability, accessibility, accommodation, acceptability).
+
+Eligibility criteria
+
+Primary research on companion animals not involved in commercial enterprises (e.g., horse racing) examining consequences of and/or risk factors for A2VC for which the full text was available in English.
+
+Sources of evidence
+
+PubMed (1996–6 July 2023) and CAB Abstracts (1973–13 July 2023, Web of ScienceTM) were searched. Additionally, a topic expert (KM) identified relevant references. Two reviewers independently screened titles/abstracts and full texts of potentially relevant references. Forward and backward citation searches were also conducted on all eligible studies using Citation Chaser.
+
+Charting methods
+
+Risk factors were categorized and mapped to the five dimensions of access to care. An evidence gap map was created using the risk factor studies.
+
+Results
+
+Fifty-one references describing fifty-two relevant studies were included. Forty-one studied risk factors associated with A2VC, and twelve studied consequences of A2VC. (One study examined both risk factors and consequences.) The majority of risk factors examined were demographic. The majority of outcomes measured were pet-centric. No relevant studies focused on pet horses, representing a gap in the literature.
+
+Conclusions
+
+Consensus needs to be reached on how A2VC is defined and measured to help reduce research wastage and strengthen impact of future studies on improving A2VC. Future studies of risk factors for A2VC should focus on creating a risk-mapping framework specific for A2VC, distinguishing factors that are susceptible to change and those which are not.
+
+1. Introduction
+
+1.1. Rationale
+
+Companion animals, particularly cats and dogs, play an essential role in the lives of many people, providing love, companionship, and a sense of purpose [1–3]. Studies have shown that pets can improve their caregivers’ mental health by reducing stress and anxiety, increasing social interaction and physical activity, and decreasing feelings of loneliness. However, accessing veterinary care can be a significant challenge for many caregivers, and this may have a negative impact on both the welfare of the animals and the physical and mental health of their caregivers [4]. The problem is that access to care is more complex than physical proximity to a care provider. Access to care in the human health field has been grouped into five dimensions: affordability, availability, accessibility, accommodation, and acceptability (Table 1) [5,6].
+
+10.1371/journal.pone.0325455.t001 Table 1 Dimensions of access to veterinary care for companion animals (based on dimensions of access to human health care [5,6]).
+
+Dimension	What is it?	
+Affordability	Cost for services, caregiver’s knowledge of cost, ability and willingness to pay, caregiver’s perception of worth	
+Availability	Ratio and type (e.g., emergency, specialty) of veterinary services to companion animals and caregiver needs in a defined geographic area	
+Accessibility	Distance between the caregiver and service(s), ease/availability/cost of transport of animal to service or veterinarian to caregiver	
+Accommodation	How services are set up to meet caregiver preferences/constraints (i.e., office hours, walk-in appointments, wait times for appointments, ability/ease of getting in touch with veterinarian)	
+Acceptability	Caregiver’s attitudes toward veterinary clinic, staff and services, veterinary clinic staff’s attitudes toward caregiver	
+
+Access to veterinary care (A2VC) is an emerging field, and research in this area has the potential to shed light on the root causes of barriers to adequate veterinary care and to inform strategies to address them [4]. Such research aligns with broader movements within the veterinary profession to promote equity and inclusivity in the membership, leadership, and organization [7]. Much of the current A2VC research has focused on identifying the extent and nature of the problem, including geographic areas and populations most affected by limited A2VC [8–13]. However, to make meaningful progress toward addressing this issue, research must move beyond identifying the problem, to assessing interventions that can improve A2VC in underserved areas.
+
+The absence of clear metrics for measuring the impact of interventions to improve A2VC represents a significant challenge. Identifying outcomes that are both relevant and measurable and that are considered important to researchers and the involved community is critical for evaluating the effectiveness of interventions. One issue we have observed is that A2VC is defined in many ways in veterinary sciences. Inconsistencies in defining the problem can create issues, such as lack of consensus about the problem being solved or an inability to compare the relative impact of different interventions. In addition, variability in how outcomes are defined and measured can make it difficult or impossible to synthesize and apply the results of different studies of animal welfare and health [14,15]. It is our belief that companion animals, their caregivers, and the veterinary services industry will all benefit from a better understanding of the current knowledge of A2VC.
+
+Scoping reviews are an evidence synthesis tool that can be used to clarify definitions of concepts within a particular topic area and to identify gaps in the current body of research [16]. At the time we conducted our literature search, screening and data charting, there were no published scoping reviews on the topic of risk factors and consequences of A2VC. Subsequently, in October of 2023, a scoping review of A2VC was published [17]. The findings of this review in the context of our own review, are covered in the Discussion section of the current study.
+
+1.2. Objectives
+
+The objectives of our scoping review were to: 1) catalog the definitions of the variable “access to veterinary care in companion animals” used by researchers, 2) identify the metrics used as risk factors for A2VC and consequences of A2VC at the individual- and group- (ecological) level, and 3) map the risk factors onto five dimensions of A2VC (affordability, availability, accessibility, accommodation, and acceptability).
+
+2. Materials and methods
+
+This scoping review is reported using the PRISMA Extension for Scoping Reviews [18].
+
+2.1. Registration
+
+The protocol for the current study is available online at Systematic Reviews for Animals and Food (SYREAF) at https://syreaf.org/wp-content/uploads/2023/07/Final-Acess-to-veterinary-care-A2VC-scoping-review-protocol-1.pdf.
+
+2.2. Eligibility criteria
+
+Eligible population: Companion animals, which may consist of dogs, cats, pocket pets, equids, or any other companion animal, including free-roaming, unowned, or stray. We did not translate studies; therefore, only studies for which the full text was available in English were eligible for inclusion. Animals that were involved in commercial enterprises (e.g., race horses, herding dogs) were not eligible. Production (food supply) animals were likewise not eligible.
+
+Eligible concept: In order to be eligible the “veterinary care” in question had to be therapeutic or preventive (e.g., vaccines) and administered by a professional (i.e., not by the caregiver; e.g., If a caregiver bought a flea collar at a pet store and put it on their pet, this would not qualify as “veterinary care”). Studies of cosmetic grooming or nutrition (pet food, pet food banks, etc.) were not eligible.
+
+Eligible study designs/ context: Studies investigating the consequences of A2VC (i.e., A2VC as an explanatory variable) were eligible. Studies investigating risk factors for A2VC were also eligible. Therefore eligible study designs comprised observational studies (cross-sectional, cohort, case-control), randomized controlled trials, and quasi-experiments (before-and-after trials). Ecological studies were also eligible. Manuscripts structured solely as reviews were not eligible. Studies for which the unit of interest was veterinary clinic staff were not eligible.
+
+2.3. Information sources
+
+A literature search was conducted in PubMed on 6 July 2023 (from 1996 to date of search) and in CAB Abstracts on 13 July 2023 (from 1973 to date of search) in the Michigan State University Web of ScienceTM interface. We searched only these two databases because, based on the authors’ extensive experience conducting systematic and scoping reviews in veterinary medical topic areas, these were considered sufficient to cover the relevant literature. We also performed forward and backward citation searches on all references that passed full-text screening using a Citation Chaser tool (https://estech.shinyapps.io/citationchaser/).
+
+We had planned, as per our protocol, to search the following sources: ASPCA and University of Minnesota Access to Veterinary Care Conference held from 17 to 19 October 2022, ASPCA Maddie’s® Shelter Medicine Conference (https://www.vet.cornell.edu/aspca-cornell-maddies-shelter-medicine-conference), Animal Care Expo (https://humanepro.org/expo), and Best Friends National Conference, and www.humananimalsupportservices.org/. However, none of these events had publicly available proceedings to search.
+
+Additional potentially relevant references were identified by our topic expert (KM) based on her expertise in the field.
+
+2.4. Search
+
+The search included 1) the (companion animal) population and 2) the A2VC concept (which included some caregiver aspects). The search in PubMed is shown in Table 2. The corresponding search performed in CAB Abstracts is shown in S1 Table. No limits were applied to the searches.
+
+10.1371/journal.pone.0325455.t002 Table 2 Search strings used in a PubMed search conducted on 6 July 2023 for a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+String	Search	No. hits	
+1	“access to veterinary care”[Title/Abstract] OR “access to care”[Title/Abstract] OR “low income”[Title/Abstract] OR “underserved”[Title/Abstract] OR “Unserved”[Title/Abstract] OR “socioeconomic”[Title/Abstract]	231,405	
+2	((“animals”[MeSH Terms:noexp] OR “animal”[All Fields] OR (“horse s”[All Fields] OR “horses”[MeSH Terms] OR “horses”[All Fields] OR “horse”[All Fields]) OR (“rabbit s”[All Fields] OR “rabbits”[MeSH Terms] OR “rabbits”[All Fields] OR “rabbit”[All Fields]) OR (“ferrets”[MeSH Terms] OR “ferrets”[All Fields] OR “ferret”[All Fields]) OR “guinea pig”[All Fields] OR (“veterinary”[MeSH Subheading] OR “veterinary”[All Fields]) OR “cat”[All Fields] OR (“dogs”[MeSH Terms] OR “dogs”[All Fields] OR “dog”[All Fields]) OR (“pet”[All Fields] AND “Or”[All Fields])) AND “companion animal”[All Fields]) OR (“canine s”[All Fields] OR “dogs”[MeSH Terms] OR “dogs”[All Fields] OR “canine”[All Fields] OR “canines”[All Fields]) OR (“cats”[MeSH Terms] OR “cats”[All Fields] OR “felines”[All Fields] OR “felidae”[MeSH Terms] OR “felidae”[All Fields] OR “feline”[All Fields]) OR “pony”[All Fields] OR (“donkey s”[All Fields] OR “equidae”[MeSH Terms] OR “equidae”[All Fields] OR “donkey”[All Fields] OR “donkeys”[All Fields]) OR (“ponies”[All Fields] AND “Or”[All Fields] AND (“equidae”[MeSH Terms] OR “equidae”[All Fields] OR “mule”[All Fields]))	587,448	
+3	#1 AND #2	708	
+
+2.5. Selection of sources of evidence
+
+The search results were downloaded in a tagged format into bibliographic software as RIS files. Separate files were obtained for the PubMed and CABI searches. These files were imported into online systematic review software (DistillerSR®) (Evidence Partners, Ottawa, ON, Canada) and de-duplicated using DistillerSR’s duplicate detection tool, followed by a manual duplication check in Excel. Before screening began, the reviewers assigned to each phase of the review underwent training to ensure consistent screening and data collection, using forms created in DistillerSR®.
+
+In the first round of screening, the titles and/or abstracts of each citation were assessed for eligibility by two reviewers working independently using the following screening question:
+
+Does the study describe primary research that either assesses risk factors for, or consequences of, any metric of access to veterinary care in companion animals?
+
+Yes (include for full-text evaluation)
+
+Unclear (include for full-text evaluation)
+
+No (exclude with no further review)
+
+No, but this looks like a potentially relevant review (exclude with no further review)
+
+A pre-test of the title/abstract screening form was conducted by all reviewers on the first 185 citations to ensure clarity and consistency of understanding of the screening question. Citations were excluded if both reviewers responded “no” to the screening question. If both reviewers said “yes” (or “unclear”), the citation advanced to full-text assessment. All conflicts were resolved prior to exclusion via discussion between the two reviewers, or, if consensus could not be reached, by consulting a third reviewer (SCT or AOC).
+
+The full text of all citations that passed title/abstract screening were procured from the Michigan State University Library or online sources, if the PDF was publicly accessible. The full-text screening form was pre-tested on one reference by all reviewers. Subsequently, two reviewers independently evaluated each of the full-text articles for eligibility with any disagreements resolved by consensus. When a consensus could not be reached, a third reviewer was consulted. The questions in the full-text eligibility assessment form were as follows:
+
+Is the full text available?
+
+Yes (proceed to Q2)
+
+No (exclude with no further review)
+
+Is the full text in English?
+
+Yes (proceed to Q3)
+
+No (specify language) (exclude with no further review)
+
+Is the study about access to veterinary care for companion animals (including unowned/stray/free-roaming)?
+
+Yes (proceed to Q4)
+
+No (exclude with no further review)
+
+At what level does the access to veterinary care metric apply?
+
+Individual (proceed to Q5)
+
+Household (e.g., distance to a veterinary clinic) (proceed to Q5)
+
+Postal Code (e.g., number of veterinary clinics in the postal code) (proceed to Q5)
+
+City/County/State/Province (e.g., number of veterinary practices in the state) (proceed to Q5)
+
+Other (e.g., veterinary clinic employees) (specify) (exclude with no further review)
+
+Correct design. Is the study design of interest?
+
+The study compares risk factors that impact A2VC (proceed to data charting)
+
+The study compares the consequences of A2VC (proceed to data charting)
+
+The study is a relevant review article (exclude with no further review)
+
+None of the above (e.g., focus group, no comparison group, non-relevant review) (exclude with no further review)
+
+2.6. Data charting process
+
+The data charting form was drafted in DistillerSR® and pre-tested with all reviewers on three references. Subsequently, each reference that passed full-text screening was categorized by two reviewers working independently, with any conflicts resolved by discussion or, if consensus could not be reached, by consulting a third reviewer. Investigators of included studies were not contacted to obtain or confirm data.
+
+2.7. Data items
+
+A list of the variables for which data were collected is provided in Table 3.
+
+10.1371/journal.pone.0325455.t003 Table 3 Data charting form for a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+Question	Type	Answer options	
+Q1. What is the Study ID? (If the reference describes only one study, the Study ID is the same as the Ref ID.)	Text		
+Q2. What type of study population is this?	Radio	Individual/Household
+
+County/Parish/State/Province, etc.
+
+	
+Q3. What was the authors’ definition of the population studied?	Text	Quote the relevant text from the reference	
+Q4. In which country/countries was the study conducted?	Checkbox	A list of countries	
+Q5. In what year(s) was the study conducted?	Text		
+Q6. What was the authors’ definition of access to veterinary care?	Text	Quoted text from the reference	
+Q7. Is this a study of risk factors affecting A2VC (e.g., demographics, socioeconomic status, etc.) or is this a study of the consequences of A2VC?	Checkbox	Risk factors
+
+Consequences
+
+	
+Q8. If this was a study of risk factors affecting A2VC, list all of the risk factors assessed.	Checkbox	A list of risk factors	
+Q9. If this was a study of consequences of A2VC, list those consequences.	Checkbox	A list of consequences	
+Q10. What risk factor was studied?	Text		
+Q11. What type of risk factor was this?	Checkbox	Human
+
+Animal
+
+	
+Q12. Was the risk factor self-reported?	Radio	Yes
+
+No
+
+	
+Q13. What dimension(s) of access to veterinary care does the risk factor map to? (Select all that apply.)	Checkbox	Affordability
+
+Availability
+
+Accommodation
+
+Accessibility
+
+Acceptability
+
+	
+Q10, Q11, Q12, and Q13 were repeated for each risk factor studied.			
+
+2.8. Critical appraisal of individual sources of evidence
+
+As this was a scoping review, we did not critically appraise the included studies.
+
+2.9. Synthesis of results
+
+After extensive discussion amongst the authors of the current study, each risk factor was categorized and mapped to one or more of the five dimensions of access to care (affordability, availability, accessibility, accommodation, and acceptability). Data from the risk factor studies was coded in EPPI-Reviewer version 4 [19] and subsequently exported to EPPI-Mapper [20] to create an Evidence Gap Map.
+
+3. Results
+
+3.1. Selection of sources of evidence
+
+The number of records identified from each source, screened, assessed for eligibility, excluded (with reasons), and included in the review are shown in Fig 1. Of the 22 references that were excluded at the full-text stage because they were not in English, 15 were in Portuguese, 4 were in Spanish, 1 was in French, 1 was in Turkish, and 1 was in Dutch. A list of citation information for all records excluded at the full-text stage, along with reasons for exclusion, are provided in S2 Table.
+
+10.1371/journal.pone.0325455.g001 Fig 1 PRISMA flow diagram [21] of the number of records identified, screened, and included in a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+3.2. Characteristics of sources of evidence
+
+Data from 51 references describing 52 studies were charted. Complete citation information for all included studies is provided in S3 Table. Of the 52 included studies, 43 studies were at the individual/household level while 9 studies were at a higher level (postal code (3 studies), zip code (1 study), neighborhood (1 study), census tract (1 study), district (1 study), county (1 study), and village (1 study)). The studies were conducted in the USA (19 studies), Brazil (5 studies), Australia (3 studies), United Kingdom (4 studies), Canada (2 studies), Haiti (2 studies), Tanzania (2 studies), and 1 study each was conducted in Burkina Faso, Cameroon, Chile, China, Democratic Republic of Congo, Ghana, Japan, Malawi, Mexico, Nigeria, Peru, Philippines, Republic of Ireland, Uganda, Vietnam, and Zambia. One study did not report the country in which it was conducted. (Note: Some studies were conducted in more than one country.)
+
+Table 4 reports the year(s) in which each included study was conducted. Thirteen studies did not report the year in which the study was conducted.
+
+10.1371/journal.pone.0325455.t004 Table 4 Years of conduct of studies included in a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+Year(s) of conduct	Number of studies	
+1992	1	
+2003	1	
+2009	1	
+2010	2	
+2011	1	
+2013	1	
+2005–2014	1	
+2014	1	
+2011–2015	1	
+2014–2015	2	
+2011–2016	1	
+2016	4	
+2008–2017	1	
+2017	2	
+2008–2018	1	
+2016–2018	1	
+2017–2018	2	
+2018	2	
+2018–2019	2	
+2014–2020	1	
+2020	7	
+2019–2021	1	
+2020–2021	1	
+2021	1	
+2022	1	
+
+Forty-one studies were of risk factors associated with access to veterinary care, while twelve studies were of consequences of access (or lack of access) to veterinary care. One study examined both risk factors and consequences of access to care.
+
+3.3. Critical appraisal within sources of evidence
+
+As this was a scoping review, critical appraisal within sources of evidence was not done.
+
+3.4. Results of individual sources of evidence
+
+Authors’ definitions of the study population and access to veterinary care for each included study are reported in S3 Table.
+
+3.5. Consequences of access to veterinary care
+
+The consequences of (lack of) access to veterinary care examined in the included studies comprised: Dog rabies vaccination coverage (three studies), canine visceral leishmaniasis infection (two studies), prevalence of spay/neuter (two studies), and one study each examined age at desexing in cats, average age in dogs, body condition in dogs, prevalence of overweight and obesity in dogs, canine health-related quality of life, clusters of canine parvovirus, pet caregiver’s trust in the veterinary profession, prevalence of desexing in cats, prevalence of heartworm prevention, prevalence of flea/tick prevention, deworming status in dogs, prevalence of injury/illness care within the past year, prevalence of preventive care within the past year, prevalence of up-to-date vaccinations, prevalence of vaccinations other than rabies, prevalence of problem behaviors in dogs, prevalence of obedience training, relinquishment of pet to a shelter, and use of an animal poison control center tele-triage service.
+
+3.6. Risk factors for access to veterinary care
+
+Tables 5–7 report the pet-related, caregiver-related, and household-/other-related risk factors, respectively, examined in the included studies, along with their corresponding mapping to the five dimensions of access to care for companion animals.
+
+10.1371/journal.pone.0325455.t005 Table 5 Pet-related risk factors mapped to the dimensions of access to veterinary care for companion animals.
+
+Risk factor (no. of studies)	Affordabilitya	Availabilityb	Accessibilityc	Accommodationd	Acceptabilitye	
+Species of pet (3)	X		X	X		
+Age of pet (13)	X		X			
+Breed of pet (6)	X					
+Size of dog (1)	X		X			
+Sex of pet (10)	X					
+Spay/neuter status of pet (6)	X					
+Pregnancy/lactating status of dog (2)	X				X	
+Primary purpose of pet (e.g., companion, guard) (3)	X					
+Source of pet (gift, purchased, found, adopted, progeny of existing pet, etc.) (8)	X					
+Pet is owned vs stray/dog resides in multiple households/confinement status (of pet) (9)	X		X			
+Dog is registered (licensed) (1)	X					
+Dog is accustomed to leash (2)	X		X		X	
+Location where the dog sleeps at night (1)	X					
+Pet has a wellness plan (1)	X					
+Pet’s vaccination history (1)	X					
+Whether the dog has had a major illness in the past (1)	X					
+Number of people bitten by pet (dog) (1)					X	
+Dog health (diseased vs healthy) (2)	X	X	X			
+aAffordability comprises cost for services, caregiver’s knowledge of cost, ability and willingness to pay, and caregiver’s perception of worth.
+
+bAvailability comprises ratio and type (e.g., emergency, specialty) of veterinary services to companion animals and caregiver needs in a defined geographic area.
+
+cAccessibility comprises distance between caregiver and service(s), ease/availability/cost of transport of animal to service or veterinarian to caregiver.
+
+dAccommodation comprises how services are set up to meet caregiver preferences/constraints: Office hours, walk-in appointments, wait times for appointments, and ability/ease of getting in touch with veterinarian.
+
+eAcceptability comprises caregiver’s attitudes toward veterinary clinic, staff and services, veterinary clinic staff’s attitudes toward caregiver.
+
+10.1371/journal.pone.0325455.t006 Table 6 Caregiver risk factors mapped to the dimensions of access to veterinary care for companion animals.
+
+Risk factor (no. of studies)	Affordabilitya	Availabilityb	Accessibilityc	Accommodationd	Acceptabilitye	
+Age (15)	X		X			
+Gender (13)	X					
+Race (5)					X	
+Ethnicity (5)					X	
+Race/ethnicity combined (1)					X	
+Caregiver is a member of a vulnerable population (1)					X	
+Social Vulnerability Index (incorporates socioeconomic status, household composition and disability, minority status and language and housing type and transportation) (1)	X	X	X	X	X	
+Socioeconomic status/income (21)	X				X	
+Caregiver qualifies for housing benefit/SNAP/WIC, etc. (2)	X				X	
+Caregiver receives public assistance (1)	X				X	
+Financial fragility (whether an unexpected $1000 veterinary bill would cause financial stress) (2)	X					
+Caregiver has pet insurance (2)	X					
+Employment status (employed, unemployed, student) (5)	X					
+Occupation (1)	X		X			
+Caregiver employed in human-/animal-health-related field (1)	X					
+Caregiver also owns livestock (1)	X	X	X			
+Marital status of caregiver (2)	X					
+Religion (2)						
+Education (14)	X		X			
+Languages spoken (1)				X		
+Who is the caregiver (head of household/other) (2)	X		X			
+Self-efficacy of caregiver (confidence that one’s actions will lead to the desired outcome) (1)	X				X	
+Caregiver’s attitude (1)	X				X	
+Dog’s caregiver is able to interact with other dog caregivers (1)	X					
+Having a veterinary clinic your family goes to (1)			X			
+Caregiver’s vaccination history (1)	X	X			X	
+Lack of trust in veterinarians (1)	X					
+Caregiver provides healthcare to animal themselves (1)	X					
+Attitude toward pet (incl. attachment) (4)	X					
+Caregiver’s risk perception regarding future dog illness (1)	X					
+Expenditure on food, toys and other non-healthcare-related items (1)	X					
+Knowledge/awareness of rabies (4)	X					
+Rabies status of last place lived in before moving to the study area (1)	X					
+Presence of someone in the household who has known someone with rabies (1)	X					
+Knowledge about mandatory dog rabies vaccination (2)	X					
+Perception of cost of rabies vaccination (1)	X					
+Length of time caregiver has lived in the area (1)	X					
+Knowledge of veterinary clinic location (1)			X			
+Thinks veterinary care is too expensive (2)	X					
+Unable to find a veterinarian nearby (1)		X	X			
+Unable to transport animal to veterinarian (4)			X	X		
+Unable to understand veterinarian (1)				X		
+No time to bring animal to veterinarian (1)			X	X		
+Caregiver thinks veterinary clinic isn’t open at convenient hours (2)				X		
+aAffordability comprises cost for services, caregiver’s knowledge of cost, ability and willingness to pay, and caregiver’s perception of worth.
+
+bAvailability comprises ratio and type (e.g., emergency, specialty) of veterinary services to companion animals and caregiver needs in a defined geographic area.
+
+cAccessibility comprises distance between caregiver and service(s), ease/availability/cost of transport of animal to service or veterinarian to caregiver.
+
+dAccommodation comprises how services are set up to meet caregiver preferences/constraints: Office hours, walk-in appointments, wait times for appointments, and ability/ease of getting in touch with veterinarian.
+
+eAcceptability comprises caregiver’s attitudes toward veterinary clinic, staff and services, veterinary clinic staff’s attitudes toward caregiver.
+
+10.1371/journal.pone.0325455.t007 Table 7 Housing and other risk factors mapped to the dimensions of access to veterinary care for companion animals.
+
+Risk factor (no. of studies)	Affordabilitya	Availabilityb	Accessibilityc	Accommodationd	Acceptabilitye	
+Housing Factors						
+Number of pets in the household (7)	X		X			
+Housing insecurity (1)	X		X		X	
+Number of people in household (9)	X					
+Presence of children (< 15 years old) in the household (3)	X		X			
+Number of children (< 5 years old) in the household (1)	X		X			
+Type of home (apartment, house, etc.) (5)	X	X				
+Home has internet access (1)	X		X	X		
+Sewage system for home (1)	X					
+Public water supply in home (1)	X					
+Public garbage collection service for home (1)	X					
+Human population density in area of residence (1)		X	X			
+Urban vs rural residence (4)		X	X			
+Housing density in the area of residence (1)		X	X			
+Geographic location (12)	X	X	X			
+Distance from household to nearest static dog vaccination point (4)			X			
+Land cover (forest/grassland/cropland/settlement) (1)		X	X			
+Land use (farm/forest/industrial/nature reserve/residential/scrub) (1)		X	X			
+Other factors						
+COVID-19 restrictions/lockdown (2)	X		X	X		
+COVID-19 pandemic (3)	X		X	X		
+Pets for Life (Humane Society of the United States’ Pets for Life program (addresses the issue of access to pet support services by offering no cost or heavily subsidized pet care services, providing transportation to and from appointments, employing bilingual staff members, building relationships with pet caregivers in the community, and partnering with local companion animal service organizations to provide services) (1)	X		X	X	X	
+Service provider’s cultural competence (1)				X		
+Mass dog vaccination opportunity (1)			X			
+aAffordability comprises cost for services, caregiver’s knowledge of cost, ability and willingness to pay, and caregiver’s perception of worth.
+
+bAvailability comprises ratio and type (e.g., emergency, specialty) of veterinary services to companion animals and caregiver needs in a defined geographic area.
+
+cAccessibility comprises distance between caregiver and service(s), ease/availability/cost of transport of animal to service or veterinarian to caregiver.
+
+dAccommodation comprises how services are set up to meet caregiver preferences/constraints: Office hours, walk-in appointments, wait times for appointments, and ability/ease of getting in touch with veterinarian.
+
+eAcceptability comprises caregiver’s attitudes toward veterinary clinic, staff and services, veterinary clinic staff’s attitudes toward caregiver.
+
+3.7. Synthesis of results
+
+An interactive evidence gap map, grouping the risk factors (pet factors, caregiver factors, household factors, and other factors) and outcomes (pet-related outcomes, caregiver-related outcomes, housing-related outcomes, and clinic-centric outcomes) is shown in S1 Fig.
+
+4. Discussion
+
+4.1. Summary of the evidence
+
+4.1.1. Definitions and metrics of access to veterinary care.
+
+Although we did not find a single, universally applied metric of access to care in the relevant studies in our review, the most commonly used metric (16 studies) was rabies vaccination coverage. While this may be relevant to certain geographic locations (i.e., where dog rabies is endemic), it is less germane in other locations (e.g., USA). Other metrics, such as spay/neuter rate, have a cultural and subjective aspect that cannot always be ascribed to lack of access to care.
+
+In the primary research studies included in our review, we found no recognized or commonly used definitions of access to veterinary care. However, a recent scoping review [17], published subsequent to our literature search, defined “underserved” with respect to lack of access to adequate veterinary care (in particular for dogs) applied to areas, communities, and animals. According to Roberts and others [17], “an Animal Health Underserved Area is a community or region that lacks adequate, accessible, and safe animal health services such that the community self-identifies that dog health and welfare and human/ community health are negatively impacted,” “an Animal Health Underserved Individual is a person who has inadequate access to animal health services such that they identify that their dog’s health and welfare or their own personal health and well-being are negatively impacted,” and “an Animal Health Underserved Population is a group or population of dogs that has inadequate access to animal health services such that, collectively or individually, the dogs’ health and welfare are negatively impacted.” We believe that, going forward, primary research studies on access to veterinary care in companion animals should utilize these definitions, perhaps expanding on them to include other species of companion animals and to consider application to a wider geographic area (the Roberts et al. [17] review covered the USA, Canada, and Australia only) to help achieve uniformity across studies and to help, as Roberts and others [17] suggest, develop a scoring system to assess severity of need to enable comparability of degree of access to care between and within studies.
+
+4.1.2. Mapping risk factors to the dimensions of access to care.
+
+We opted to use a previously published dimensional framework described by Penchansky and Thomas [5], for mapping access to care. However, because this framework was created in the context of human health care access, applying it to veterinary health care access presented a challenge in certain ways. For instance, the affordability dimension encompasses both willingness and ability to pay. Ability to pay is an important barrier to veterinary care. Willingness to pay is also an issue in veterinary care, particularly for preventive care, which people may not see as valuable [22,23]. Ability and willingness to pay are two separate problems with separate solutions and by mapping them onto the single dimension of affordability, some nuance may be lost.
+
+Mapping the risk factors to the five dimensions of access to care was a complex task involving many subjective judgments and much discussion amongst the authors of the current study. Of the 18 pet-related risk factors, 9 (50%) were difficult to map (number pets in the household, species, breed, size, purpose, pregnancy/lactating status, accustomed to leash, and pet health), which is not surprising, given that the mapping framework was designed for mapping human health care access. In contrast, a lower percentage of the caregiver-related factors were challenging to map (13/44; 30%); these factors included the demographic factors (age, race/ethnicity, religion, gender, self-efficacy, and occupation), economic factors (socioeconomic status, pet insurance) and factors such as whether the caregiver owns livestock, interacts with other dog caregivers, vaccination history, rabies status of previous place lived in and whether they were able to transport their pet to the veterinarian. The translation of human demographic factors from a healthcare access standpoint to a veterinary care access standpoint is a complex one, and, rather than debate where each factor should be mapped to the current framework, it might be more pertinent to consider which factors are more salient in a different framework designed specifically for veterinary care access. Of the household-related risk factors, 4 out of 17 (25%) were challenging to map (internet access, sewage system present, housing density in area of residence, and geographic location).
+
+4.1.3. Overall findings.
+
+Although we did not exclude equine companion animals from our review, we did not find any studies focusing on access to care for companion horses, and this represents a gap in the primary literature. Additionally, though less surprisingly, we likewise did not find any studies focusing on pocket pets.
+
+Our study identified the need for a risk-mapping framework specific to access to veterinary care. In particular, one that distinguishes between the caregivers’ ability and willingness to pay. Ideally, this framework would also distinguish between which factors are susceptible to intervention (e.g., economic risk factors and the attitudes, perceptions, and knowledge of caregivers) and those which are not (e.g., pet and caregiver demographic factors). It might also be useful if the framework also maps factors by which sector has control over them (e.g., veterinary-controlled vs caregiver-controlled).
+
+4.1.4. Evidence gap map.
+
+The majority of outcomes measured in the included studies were pet-centric, possibly because these outcomes are easier to measure than clinic-centric or caregiver-centric outcomes, and there are fewer issues over confidentiality. Demographic risk factors (for pets and caregivers and location of household) were commonly assessed, possibly because these factors are easy to measure. However, the issue with demographic factors is that they tend to be immutable, or at least, difficult to change. Economic risk factors and the attitudes, perceptions, and knowledge of caregivers are probably the most useful factors to study as they can be susceptible to improvement with various interventions.
+
+4.2. Limitations
+
+Because our review was restricted to references for which the full text was available in English, 22 potentially relevant references were excluded at the full-text stage because they were not in English. As a consequence, our results are biased towards countries in which authors tend to publish studies in English.
+
+Another limitation of our review is that some of our risk factor mapping was subjective (as outlined above) and open to debate.. Although we used a previously published framework for risk factor mapping, this framework was designed for human health studies and thus presented challenges in applying it to veterinary care access. There appears to be a need for a more suitable access framework, in particular to address the risk factors that were particularly difficult to map using the human health framework (race, ethnicity, religion, etc.). This work was designed to highlight the current state of knowledge, to identify gaps in the literature, and to initiate discussion on alignment and lexicon, to encourage and stimulate ongoing and robust research in this area.
+
+5. Conclusions
+
+Although it is probably unrealistic to create a definition of access to veterinary care that would be applicable worldwide, getting alignment on a commonly accepted definition, perhaps specific to certain parts of the world, would be major progress in and of itself.
+
+This review identified a need for a risk factor mapping framework specific to access to veterinary care, specifically, one which distinguishes between which factors are susceptible to intervention (e.g., attitudes, perceptions, and knowledge of caregivers) and those which are not (e.g., pet and caregiver demographic factors).
+
+We plan to use the information from this review to conduct a consultative project with experts and community members to capture opinions about the dimensions of A2VC captured by the metrics and value (high value/ low value), mutable and immutable consequences, and individual- and group-level metrics of impact. We will then develop a proposal for a core set of outcomes and definitions for A2VC and dimensions for use by future researchers to design studies that can assess the impact of interventions on veterinary care access.
+
+Supporting information
+
+S1 Table Search strings used in a CAB Abstracts search conducted on 13 July 2023 for a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+(DOCX)
+
+S2 Table Records excluded after full-text evaluation, with reasons for exclusion, in a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+(XLSX)
+
+S3 Table Complete citation information and authors’ definitions of the study population and definitions of access to veterinary care for all included studies in a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+(XLSX)
+
+S1 Fig An interactive evidence gap map, grouping the risk factors (pet factors, caregiver factors, household factors, and other factors) and outcomes (pet-related outcomes, caregiver-related outcomes, housing-related outcomes, and clinic-centric outcomes) from a scoping review of risk factors for, metrics of, and consequences of access to veterinary care for companion animals.
+
+(HTML)
+
+S1 File PRISMA Scoping Review Checklist for revised manuscript.
+
+(PDF)
+
+
+References
+
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+2 Purewal R , Christley R , Kordas K , Joinson C , Meints K , Gee N , et al. Companion Animals and Child/Adolescent Development: A Systematic Review of the Evidence. Int J Environ Res Public Health. 2017;14(3):234. doi: 10.3390/ijerph14030234 28264460 PMC5369070
+3 Williams CYK , Townson AT , Kapur M , Ferreira AF , Nunn R , Galante J , et al. Interventions to reduce social isolation and loneliness during COVID-19 physical distancing measures: A rapid systematic review. PLoS One. 2021;16(2):e0247139. doi: 10.1371/journal.pone.0247139 33596273 PMC7888614
+4 Lem M . Barriers to accessible veterinary care. Can Vet J. 2019;60(8):891–3. 31391609 PMC6625179
+5 Penchansky R , Thomas JW . The concept of access: definition and relationship to consumer satisfaction. Med Care. 1981;19(2):127–40. doi: 10.1097/00005650-198102000-00001 7206846
+6 McLaughlin CG , Wyszewianski L . Access to care: remembering old lessons. Health Serv Res. 2002;37(6):1441–3. doi: 10.1111/1475-6773.12171 12546280 PMC1464050
+7 American Veterinary Medical Association [Internet]. Schaumburg: AVMA; [cited 2024 March 15]. Diversity, equity, and inclusion in veterinary medicine; [about 2 screens]. Available from: https://www.avma.org/resources-tools/diversity-and-inclusion-veterinary-medicine#:~:text=AVMA%20and%20the%20American%20Association,actionable%20goals%20with%20defined%20timeframes
+8 Neal SM , Greenberg MJ . Putting Access to Veterinary Care on the Map: A Veterinary Care Accessibility Index. Front Vet Sci. 2022;9:857644. doi: 10.3389/fvets.2022.857644 35445097 PMC9014118
+9 Friedman E , Krause-Parello CA . Companion animals and human health: benefits, challenges, and the road ahead for human-animal interaction. Rev Sci Tech. 2018;37(1):71–82. doi: 10.20506/rst.37.1.2741 30209428
+10 Chur-Hansen A , Stern C , Winefield H . Gaps in the evidence about companion animals and human health: some suggestions for progress. Int J Evid Based Healthc. 2010;8(3):140–6. doi: 10.1111/j.1744-1609.2010.00176.x 21199382
+11 Berrada M , Ndiaye Y , Raboisson D , Lhermie G . Spatial evaluation of animal health care accessibility and veterinary shortage in France. Sci Rep. 2022;12(1):13022. doi: 10.1038/s41598-022-15600-0 35906375 PMC9338267
+12 Bergia F , Fortin M-È , Patry J . Linking animal health to human health by establishing veterinary services within a community health clinic: Overall health of marginalized people. Can Fam Physician. 2022;68(7):485–6. doi: 10.46747/cfp.6807485 35831085 PMC9842146
+13 Baker T , Rock M , Brook R , van der Meer F , Kutz S . Indigenous community perspectives on dogs in Northern Canada after 10 years of veterinary services indicates improved animal and human welfare. Prev Vet Med. 2020;181:105061. doi: 10.1016/j.prevetmed.2020.105061 32599372
+14 Dzikamunhenga RS , Anthony R , Coetzee J , Gould S , Johnson A , Karriker L , et al. Pain management in the neonatal piglet during routine management procedures. Part 1: a systematic review of randomized and non-randomized intervention studies. Anim Health Res Rev. 2014;15(1):14–38. doi: 10.1017/S1466252314000061 25605277
+15 Sargeant JM , O’Connor AM , LeBlanc SJ , Winder CB . Invited review: Maximizing value and minimizing waste in clinical trial research in dairy cattle: Selecting interventions and outcomes to build an evidence base. J Dairy Sci. 2022;105(11):8594–608. doi: 10.3168/jds.2022-22015 36055845
+16 Munn Z , Peters MDJ , Stern C , Tufanaru C , McArthur A , Aromataris E . Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol. 2018;18(1):143. doi: 10.1186/s12874-018-0611-x 30453902 PMC6245623
+17 Roberts C , Woodsworth J , Carlson K , Reeves T , Epp T . Defining the term “underserved:” A scoping review towards a standardized description of inadequate access to veterinary services. Can Vet J. 2023;64(10):941–50. 37780475 PMC10506354
+18 Tricco AC , Lillie E , Zarin W , O’Brien KK , Colquhoun H , Levac D , et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018;169(7):467–73. doi: 10.7326/M18-0850 30178033
+19 Thomas J , Graziosi S , Brunton J , Ghouze Z , O’Driscoll P , Bond M . et al. Version 4 [software]. EPPI-Reviewer: advanced software for systematic reviews, maps and evidence synthesis. EPPI Centre, UCL Social Research Institute, University College London. 2023 [cited 5 Dec 2023]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=2914
+20 Digital Solution Foundry and EPPI Centre. EPPI-Mapper. Version 2.2.4. EPPI Centre, UCL Social Research Institute, University College London. 2023 [cited 6 Dec 2023]. Available from: https://eppi.ioe.ac.uk/cms/Default.aspx?tabid=3790
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Med Law Rev
+Journal ID: Med Law Rev
+NLM Journal ID: 9308945
+Journal ID: medlaw
+
+Medical Law Review
+
+ISSN: 0967-0742
+EISSN: 1464-3790
+Publisher: Oxford University Press
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13091612
+PMID: 41999639
+DOI: 10.1093/medlaw/fwag009
+Article ID: fwag009
+Article version: 1
+Subjects: Original Article, AcademicSubjects/LAW00490
+
+Medical misogyny: understanding epistemic injustice to achieve safer healthcare for women in the UK
+
+https://orcid.org/0000-0002-7269-158X O’Donovan Laura School of Law, University of Sheffield, Bartolome House, Winter Street, Sheffield, S3 7ND, United Kingdom
+
+https://orcid.org/0000-0002-1035-5695 Devaney Sarah Law Department, University of Manchester, Williamson Building, Oxford Road, Manchester, M13 9PL,United Kingdom
+
+https://orcid.org/0000-0001-5006-4932 Mullock Alexandra Law Department, University of Manchester, Williamson Building, Oxford Road, Manchester, M13 9PL,United Kingdom
+
+https://orcid.org/0000-0002-1349-3612 Moore Victoria L Law Department, University of Manchester, Williamson Building, Oxford Road, Manchester, M13 9PL,United Kingdom
+
+Corresponding author. School of Law, University of Sheffield, Sheffield S3 7ND England. E-mail: l.odonovan@sheffield.ac.uk
+Publication date: 2026 Spring
+Electronic publication date: 2026 Apr 18
+Volume: 34
+Issue: 2
+Electronic Location ID: fwag009
+Copyright: © The Author(s) 2026. Published by Oxford University Press.
+Copyright year: 2026
+License: This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Funding: Wellcome 10.13039/100004440 222858/Z/21/Z University of Manchester School of Social Sciences Recovery Support
+Page count: 30
+
+Ÿ==============================Ÿ
+Abstract
+
+Since 2019, numerous reports (both official and charity-led) have been published detailing patient care and safety failings in areas of women’s healthcare in hospitals across the UK. A common theme that has emerged from these reports is a sense that the voices of women and people seeking maternity care and/or treatment for female health conditions are frequently dismissed and silenced. While many of the examples detailed in these reports have been appropriately recognized as both individual and systemic failings in patient care, here we apply Miranda Fricker’s epistemic injustice framework to these issues. We argue that testimonial injustice (a form of discriminatory epistemic injustice) forms a core part of the experience of some of these patients’ care resulting in a compounding of their experience of harm. Despite various exhortations within the reports that women should be listened to, the evidence demonstrates that women’s testimonial knowledge is systematically devalued. We thus contend that a fundamental reframing of the issue is required and that understanding how and why epistemic injustice occurs is critical to developing a better understanding of how to avoid it, both in the provision of women’s healthcare and in its regulation.
+
+I. Introduction
+
+Over the past 6 years, numerous reports have been published detailing the various avoidable harms suffered by women and people assigned female at birth as a result of patient care and safety failings in areas of women’s healthcare1 in hospitals across the UK. Here we refer to healthcare services that focus on the treatment and care of diseases and conditions that are unique to people of female biology, predominantly women. These concern, for example, uterus and ovary health, cervix, vagina and vulva health, and pregnancy.2 In this article, we argue that many of the examples of poor care highlighted by the different reports can and should be viewed as instances of epistemic injustice, causing harm that is avoidable, and that understanding epistemic injustice is an important step towards ameliorating medical misogyny and its resulting physical and emotional consequences.
+
+We focus on seven high-profile reports published between 2019 and 2024 concerning areas of ‘women’s healthcare’ rather than investigations into healthcare across the National Health Service (NHS) more broadly. This stems from a recognition of the documented gender disparities in healthcare provision and outcomes, as highlighted in the previous UK government’s Women’s Health Strategy.3 There it was noted that ‘[n]ot enough focus is placed on women-specific issues like miscarriage or menopause’,4 and that ‘too often it is women whom the healthcare system fails to keep safe and fails to listen to’.5 Given this, a targeted examination of areas where these issues may be most pronounced is required. The reports we draw from are the 2020 Cumberlege Report6; four reports published in 2022: the Ockenden Report,7 the Birthrights Report,8 the Five X More Report,9 and the Kirkup Report10; the 2023 Unheard Report11; and the 2024 Birth Trauma Report.12 While the focus and scope of each of these reports is different, they collectively identify multiple ways in which women and people with female anatomy have suffered myriad harms either (i) as part of their maternity care, (ii) when receiving care for conditions affecting their female anatomy, and/or (iii) during the course of other healthcare treatment which has then affected elements of their reproductive health and well-being.
+
+A common theme that we argue has emerged in the findings of these inquiries is a sense that the voices of women and people seeking care for female health conditions are frequently dismissed and silenced.13 While many of the examples and cases detailed in these reports have been appropriately recognized as both individual and systemic failings in patient care, in this article, we apply Miranda Fricker’s theory of epistemic injustice to further elucidate these issues. We suggest that this, in turn, can contribute to the implementation of more effective regulatory regimes to prevent harm and avoid compounding it in its aftermath.14
+
+We argue that testimonial injustice (a form of discriminatory epistemic injustice) formed a core part of the experience of some patients’ care, compounding their experiences of their illness or condition, and/or of their experience of harm caused during their treatment. In some instances, ignoring or dismissing patient concerns resulted in diagnostic failings and negligent treatment, leading to serious harm and even death.15 It is therefore critical to examine how and why epistemic injustice occurs in order to develop a better understanding of how to avoid it, both in the provision of care and in its regulation.
+
+In 2022, the Conservative government’s response to failings in women’s healthcare was to launch a Women’s Health Strategy for England16—an initiative that the current Labour government has explicitly committed to take forward as part of its 10-year plan to fix the NHS.17 The aim of the strategy is: (i) to boost health outcomes for women and girls and (ii) to radically improve the way in which the health and care system engages and listens to women and girls.18 It is notable that within this strategy, improving how healthcare professionals (HCPs) and the wider healthcare system centres and respects women’s voices constitutes one of the two key policy aims. What this suggests, and what we hope to demonstrate in this article, is that testimonial injustice experienced by women is both a widespread and pernicious issue, amounting to ‘medical misogyny’19 that requires a much more robust regulatory response.
+
+We build our case as follows. In Section II, we provide the context by first briefly setting out the nature and scope of the inquiries into patient care and safety failings that are our primary focus. Section III outlines the account of epistemic injustice which underpins our analysis, and its manifestation in the healthcare context. In Section IV, we evidence the ways in which some of the individual and structural identity prejudices operating in women’s healthcare have led to testimonial injustice. Section V explores and articulates the primary and consequential harms patients have suffered as a result of these injustices. We also consider how testimonial injustice damages trust in healthcare systems and professionals, which in turn impairs the therapeutic relationship. On the basis of this evidence, in Section VI we provide recommendations as to how patient safety regulation frameworks need to improve, both to provide accurate insights into where and why failings are happening, and to help avoid perpetuating the harms we have identified.
+
+Finally, we wish to emphasize that while our analysis focuses on reports concerning reproductive and sex-specific healthcare, the patterns of epistemic injustice we identify are likely not confined to these domains of women’s healthcare. The choice to focus here reflects the availability of detailed inquiry reports rather than a judgment that these are the only areas affected by testimonial injustice.
+
+II. Background and methodology
+
+As mentioned in the introduction, in this article, we focus specifically on seven high-profile reports published between 2019 and 2024 concerning areas of ‘women’s healthcare’. There is now a long and well-established history in the UK of extensive reviews of, and inquiries into, patient safety failings, identifying problematic cultures of practice, including failures to listen to patients, and delays in taking action to improve patient care.20 Despite the resulting recommendations in review and inquiry reports on how to improve care, patients have continued to suffer appalling failings in treatment provision. See Table 1 for a chronological overview of the seven reports we focus on in this article.
+
+Table 1 Overview of reports.
+
+Report title	Year of publication	Type of investigation	Period of care covered	Area of healthcare	Key findings (emphasis added)	
+Report of the Independent Medicines and Medical Devices Safety Review (‘the Cumberlege Report’)	July 2020 	Independent review commissioned in 2018 by the Secretary of State for Health and Social Care	Cases spanning from the 1960s (Primodos first used) to the time of review (exact dates unspecified)	Hormone pregnancy tests;
+
+Sodium valproate (an anti-epileptic drug); and
+
+Pelvic mesh implants
+
+	Across all three health interventions, common themes were: The lack of information to make informed choices;
+
+Lack of awareness of who to complain to and how to report adverse events;
+
+The struggle to be heard; 
+
+Not being believed; 
+
+Dismissive and unhelpful attitudes on the part of some clinicians; 
+
+A sense of abandonment; 
+
+Life-changing consequences, not only for those directly affected, but for their families and friends too; 
+
+Breakdown of family life;
+
+Loss of jobs, financial support and sometimes housing;
+
+Loss of identity and self-worth;
+
+A persistent feeling of guilt;
+
+Children becoming their mothers’ and siblings’ carers;
+
+Clinicians are untutored in the skills they need to make a proper diagnosis;
+
+Clinicians not knowing how to learn from patients; 
+
+Inaccurate or altered patient records; and
+
+A lack of interest in, and an inability to deliver, the monitoring of adverse outcomes and long-term follow-up across the healthcare system.
+
+	
+Final Report from the Independent Review of Maternity Services at The Shrewsbury and Telford Hospital NHS Trust (the ‘Ockenden Report’)	March 2022 	Independent review commissioned in 2017 by the Secretary of State for Health and Social Care	2000–2019	Maternity services	Patterns of repeated poor care, including:
+
+ ○ Failures to investigate, inform, and listen; 
+
+ ○ Care that was not in line with best practice at the time; 
+
+ ○ Care that could have been significantly improved; 
+
+ ○ Repeated failures to escalate concerns in both antenatal and postnatal environments;
+
+ ○ Delays in treatment; and
+
+ ○ Lack of appropriate escalation;
+
+Multiple failures in governance and leadership with devastating consequences:
+
+ ○ Failure to follow national clinical guidelines;
+
+ ○ Lack of action from senior clinicians;
+
+ ○ Lack of psychological safety in the workplace and cultural issues;
+
+ ○ Lack of compassion;
+
+ ○ Significant staffing and training gaps;
+
+ ○ Unsafe inpatient-to-staffing ratios; and
+
+ ○ Lack of oversight and full understanding by the Trust board.
+
+	
+Inquiry into Racial Injustice and Human Rights in UK Maternity Care (‘the Birthrights Report’)	May 2022 	Inquiry by charity	Poll—last 5 years = 2017–2022
+
+Oral evidence—21 February to 22 January
+
+	Maternity services	Common themes emerged from the evidence: Lack of physical and psychological safety;
+
+Being ignored and disbelieved; 
+
+Racism by caregivers; 
+
+Dehumanization; 
+
+Lack of choice, consent, and coercion;
+
+Structural barriers; and
+
+Workforce representation and culture.
+
+	
+The Black Maternity Experiences Survey (the Five X More Report)	May 2022 	Study by a charity	2019–2021	Maternity services	Negative experiences were found to fit within a framework overarched by three interrelated constructs centred around the healthcare professional (HCP): Attitudes (eg using offensive and racially discriminatory language; being dismissive of concerns); 
+
+Knowledge (eg poor understanding of the anatomy and physiology of Black women; poor understanding of the clinical presentation of conditions in babies of Black women); and
+
+Assumptions (eg racially based assumptions about the pain tolerance, education level, and relationship status of Black women). 
+
+	
+Report of the Independent Investigation into Maternity and Neonatal Services in East Kent (‘the Kirkup Report’)	October 2022 	Independent review commissioned in 2020 by Minister of State for Patient Safety, Mental Health and Suicide Prevention, Department of Health and Social Care	2009–2020	Maternity services	The origins of the harm identified lie in the following: Failures of teamworking;
+
+Failures of professionalism;
+
+Failures of compassion; 
+
+Failures to listen; 
+
+Failures after safety incidents; and
+
+Failure in the Trust’s response.
+
+	
+Unheard: Women’s Journey Through Gynaecological Cancer (the Unheard Report’)	December 2023 	Inquiry by the Health and Social Care Committee, Welsh Parliament	Not specified. Call for evidence between 22 October and 23 March appears to focus on current rather than historic experiences.	Gynaecological cancer care	Of particular relevance to this article: A strong theme that came through in the evidence we heard on this inquiry was that many women continue to feel unheard in healthcare settings (para 31).
+
+It is clear that women’s health needs to be given a higher priority than has previously been the case. Women need to access the care they need when they need it. The health service needs to be responsive in providing that care. Most importantly, it needs to listen to women and respond to their health concerns appropriately. (para 35).
+
+	
+Listen to Mums: Ending the Postcode Lottery on Perinatal Care (‘the Birth Trauma Report’).	May 2024 	Inquiry by All-Party Parliamentary Group on Birth Trauma	Open ended	Maternity services	Key themes: Failure to listen; 
+
+Lack of informed consent;
+
+Poor communication; 
+
+Lack of pain relief; 
+
+Lack of kindness; 
+
+Breastfeeding problems;
+
+Poor post-natal care;
+
+The impact of covid and
+
+Complaints and medical negligence.
+
+	
+
+Our selection criteria focused on reports addressing various aspects of women’s health, with particular attention to those that garnered significant public and policy attention. While not employing a systematic review methodology, we prioritized reports that demonstrated substantial impact within the broader discourse on the gender health gap. This approach allowed for the identification of key documents that have shaped contemporary understanding of women’s health disparities and associated policy responses.
+
+Our analytical framework employed Fricker’s conceptualization of testimonial injustice to examine the selected reports. We specifically sought to identify instances where women’s testimonies and experiences were subject to credibility deficits due to prejudicial assumptions. The analysis focused on identifying patterns of testimonial injustice, particularly examining contexts where women reported feeling unheard, dismissed, or experiencing systematic undermining of their credibility within healthcare settings. Through this theoretical lens, we extracted and analysed quotations that exemplified these dynamics, seeking to illuminate the epistemic dimensions of women’s healthcare experiences.
+
+III. Understanding epistemic injustice
+
+Long before the philosopher Miranda Fricker coined the term epistemic injustice to describe what she suggests is a ‘wrong done to someone specifically in their capacity as a knower’,21 Black feminist activists and writers such as Anna Julia Cooper and Sojourner Truth were sharing their experiences of having their truth silenced and dismissed.22 Indeed, examples of epistemic resistance (calling attention to the ways in which particular knowers have been silenced and marginalized)23 ‘can be traced to [historical] discussions around intersections of power, knowledge and oppression’.24 In 1867, for example, Sojourner Truth, a woman’s rights activist and abolitionist, spoke of society’s silencing and denying the credibility of Black women as knowers.25 In recent times, the concept of epistemic injustice has gained prominence through the work of Fricker, who identifies two forms of injustice that are distinctly epistemic in nature: testimonial injustice and hermeneutical injustice.26
+
+A. The central cases of testimonial and hermeneutical injustice
+
+Testimonial injustice occurs when, owing to some particular prejudice—the ‘ethical poison’ of testimonial injustice27—a hearer unduly attributes a deflated level of credibility to a speaker, which affects their acceptance of the speaker’s testimony, and results in them being designated as an epistemic lesser.28 It is, according to Fricker, the wrongful undermining of the speaker specifically in their capacity as a knower, which may lead to the hearer missing out on knowledge as a result.29 This may occur after a speaker has told or asserted something to the hearer, asked a question, or contributed to an epistemic exchange in some other way. It may also operate pre-emptively,30 when the hearer fails to even solicit the views of the epistemic subject because they perceive them to lack credibility.31
+
+By contrast, hermeneutical injustice occurs where a particular type of epistemic gap exists between a person’s experience, their ability to render that experience communicatively intelligible and the hearer’s ability to understand it.32 This lack of sufficient shared concepts between subjects is owed to what Fricker terms ‘hermeneutical marginalisation’—unequal participation in the exercise of meaning-making practices.33 The example frequently used to illustrate it is that of sexual harassment.34 Prior to society’s collective understanding and labelling of this social experience as sexual harassment, no term to describe this concept existed due to the fact that women’s experiences were not adequately reflected by common shared concepts.35 As such, those experiencing this kind of abuse may have struggled both to make themselves understood when trying to share their experience and to be believed by others due to the previous paucity of the shared concept.36
+
+Our focus in this article is on the effect of testimonial injustice in women’s healthcare.37 While prejudice can take a variety of different forms, prejudice in the central case of testimonial injustice advanced by Fricker is that of ‘identity prejudice’—‘a label for prejudices against people qua social type’.38 Typical examples include, but are not limited to, negative social stereotypes or biases on the basis of gender, race, sex, religion, socio-economic status, or educational status. Fricker draws on the fictional example of the case of Tom Robinson’s jury trial in Harper Lee’s novel To Kill a Mockingbird to illustrate an (extreme) example of testimonial injustice.39 Here, we highlight what we suggest is an illustrative example from the healthcare setting.40
+
+Kathy had been experiencing heavy periods that left her feeling so faint that she was unable to stand upright. Four different medical professionals suggested to her that she was struggling with anxiety and not a physical illness. According to Kathy, her primary care doctor told her that ‘all your symptoms are your [sic] imagination’.41 It was only when Kathy pushed for an ultrasound scan after suffering with debilitating symptoms for 9 months that she was diagnosed with uterine fibroids requiring surgical intervention.42 She was suffering from anaemia and not anxiety.43 This example arguably bears all the hallmarks of testimonial injustice. First, the treating HCPs afforded Kathy reduced credibility as a knower of her own bodily experiences, dismissing her accounts of physical symptoms. Secondly, this credibility deficit appears rooted in prejudicial stereotyping of ill women as anxious, overly emotional, and unreliable narrators of their experiences. Thirdly, this epistemic wrong caused significant harm: Kathy’s health concerns were dismissed, and the opportunity for early diagnosis and treatment was missed, prolonging her suffering for 9 months. These features taken together constitute a clear case of testimonial injustice, and unfortunately, as we demonstrate in Section IV, Kathy’s experience is not an isolated one.
+
+B. The harms of epistemic injustice
+
+The harms of the above types of epistemic injustice are characterized by Fricker as primary (intrinsic) and secondary (extrinsic) harms.44 The primary harm of testimonial injustice is that one is undermined in one’s capacity as an epistemic subject.45 This is to say that one is ‘undermined or otherwise wronged in a capacity that is essential to human value’,46 that is, as a knower and therefore a credible speaker.47 The secondary harms are the practical, often tangible consequences which flow from the primary harm, and we therefore describe these as ‘consequential harms’.
+
+Consequential, secondary harms consist of ‘a range of possible follow‐on disadvantages, extrinsic to the primary injustice in that they are caused by it rather than being a proper part of it’.48 The first category of secondary harm is the practical consequences that may follow, which in healthcare may be significant physical and/or psychiatric harm in circumstances where it is the failure of care, that is, ignoring or dismissing the patient’s testimony, that led to the harm occurring. As we discuss in Section , such tangible harm might also be regarded as a legally recognizable harm invoking civil or even (rarely) criminal liability. The second category of consequential harm is ‘(more purely) epistemic harm’,49 such as the target of the testimonial injustice becoming more widely perceived as having lower epistemic status, or their own confidence in their epistemic capacity being eroded into the future.50 Women who experience repeated dismissal of their symptoms may internalize the message that their accounts are unreliable. This loss of confidence can in turn damage trust in healthcare professionals and systems, with evidence suggesting that some women become so traumatized by experiences of dismissal that they will not seek care unless it is absolutely life-threatening.51 We return to the consequences of this erosion of trust in the Section V.
+
+C. Epistemic injustice in the healthcare context broadly
+
+A wide range of literature exists exploring the occurrence of epistemic injustice due to the power imbalance, which potentially makes patients vulnerable in a number of health contexts.52 Carel and Kidd, for instance, explain that healthcare systems are grounded upon ‘complex structures of epistemic norms and expectations, both implicit and explicit that create knowledge asymmetries’,53 for example, the privileging of certain forms of knowledge. In the medical context, they suggest this refers to knowledge gained from medical training and theory rather than that which is grounded in patients’ embodied experience of illness.54 They argue that the power structures inherent in healthcare institutions and systems ‘can also indirectly affect the epistemic confidence and capacities of ill persons’,55 in that illness may render patients vulnerable and fragile in ways that ‘challenge the autonomy and dignity that epistemic agency requires’.56 As a result, it is suggested that ill persons are particularly vulnerable to both testimonial and hermeneutical injustice.57 This arises for the following two reasons.
+
+First, in the clinical context, patients find themselves within a particular power relationship, for ‘power is present in all interpersonal relationships; there is thus no interaction in which power is not relevant in healthcare’.58 While patient empowerment and moving away from medical paternalism have been an important health policy within the NHS59 (and other healthcare systems),60 by default, it is always HCPs who ‘have power available to them through their cultural and symbolic capital legitimized by the institution of medicine’.61 As such, HCPs, in particular, physicians, enjoy epistemic privilege or advantage in ways that may be warranted by virtue of their education and training,62 and also unwarranted where, for example, such advantage is grounded in presumptive judgements about the epistemic credibility and thus privilege that should be afforded to someone.63
+
+Secondly, negative stereotypes and biases applicable to patients and ill persons as a social group often diminish their perceived epistemic competence and capabilities.64 The ill persons that Kidd and Carel are referring to are those who experience chronic somatic conditions65—a specific subgroup of ill patients.66 However, the stereotypes of chronically ill persons they identify are stereotypes that are applicable to the category of ill persons or patients in the healthcare setting generally, though chronically ill persons may be subjected to them more frequently and possibly to a greater degree. These stereotypes are particular identity characterizations unique to the clinical context,67 including descriptions of ill persons as ‘cognitively impaired or emotionally compromised’,68 or irrational, anxious or ‘psychologically dominated by their illness in a way that warps their capacity to accurately describe and report their experiences’.69 While birthing women and people are generally not a group who are ‘ill’, given pregnancy is not a disease, as one of us has noted, their engagement with maternity services positions them within the healthcare system’s hierarchical power structure, which tends to afford greater epistemic privilege to HCPs at the expense of affording sufficient credibility to the lived experience of patients.70 As such, she posits that just as with women engaging with the healthcare system as ‘patients’, birthing women and people may also be vulnerable to epistemic injustice as female users of the healthcare system.71
+
+Such prejudicial characterizations of patients, ill persons, or birthing women and people may be further compounded by other social prejudices72 held by HCPs, which, according to Kidd and Carel, tend to ‘prejudicially deprive ill persons of the prerequisites of reliable epistemic conduct … and also attribute to them characteristics … that are usually (and contentiously) supposed to be opposed to rationality and reliability’,73 leading to their testimonies being accorded a lower level of credibility than they otherwise would have been. Having outlined the account of epistemic injustice underpinning our analysis and an account of its operation in the healthcare context broadly, we now apply this to the case of women’s healthcare.
+
+IV. Evidencing testimonial injustice in women’s healthcare
+
+Drawing on the reports outlined in Table 1, in this section, we evidence the existence of testimonial injustice in women’s healthcare in the UK. Here, we argue that women’s adverse and sometimes catastrophic health experiences are, in part, a consequence of prejudices against them as a social group. Indeed, taken together, the reports demonstrate a pernicious systemic failure in the provision of women’s healthcare in the NHS that is reflective of a wider healthcare culture in which female bodies are mythologized and accounts of female pain are distrusted.74 Below, we consider two prejudices evident in the reports considered: gender and race.
+
+A. Gender prejudice
+
+Inequality has long existed between men and women. As Auchmuty posits, ‘women have not simply been unequal to men, they have been oppressed by them and the institutions of patriarchy constructed to perpetuate male power’.75 Such oppression and division are also reproduced in the medical sphere, and Cleghorn, for example, argues that ‘at every stage in its long history, medicine has absorbed and enforced socially constructed gender divisions … [which] have traditionally ascribed power and dominance to men’.76 This is because although medicine and its history may appear to be objective, logical, and based on evidence, it too ‘is every bit as social and cultural as it is scientific’.77 Medicine has developed within these conditions and, as such, ‘male dominance –and with it the superiority of the male body– was cemented into medicine’s very foundations’.78
+
+As the concept of modern medicine emerged from Ancient Greece, so too did the idea that the female body was inferior to the male body. Texts from the Presocratics to Galen typically positioned the male body as the point of reference from which the female body deviated.79 Females were thus characterized as incomplete or the inverse of the male body.80 Biological difference not only defined the female body but also constrained it, with ‘women’s illnesses and diseases consistently related back to the “secrets” and “curiosities” of her reproductive organs’.81 This can be seen in the emergence and history of the condition ‘hysteria’ (from the Greek hystera, or uterus), the cause of which the Ancient Greeks and the Victorians attributed to the uterus.82 Notably, it was not until 1980 that ‘hysterical neurosis’ was removed from the Diagnostic and Statistical Manual of Mental Disorders (DSM-III).83
+
+The practice of medicine and the medical establishment have thus evolved and developed in the context of particular beliefs and myths about the female body, and patriarchal attitudes within societies where historically women were effectively owned by their father or husband.84 Medical knowledge and research has also been shaped by these notions. For example, clinical studies have historically excluded female participants because of the ‘risks’ posed by hormones or pregnancy. Instead, research data collected from males has been generalized to females and intersex people.85 This has resulted in a dearth of knowledge when it comes to how different diseases present and manifest in women and those with female biology, and also, an extant knowledge gap about conditions and diseases which specifically affect female reproductive anatomy—the uterus, ovaries, and fallopian tubes.86
+
+Within the seven reports under consideration, specifically in the testimonies of those who provided evidence, there is a sense that women were not seen as experts of their own bodies, conditions, or symptoms. Consider, for example, the experiences of two former mesh implant patients:‘They would tell you there is nothing wrong with you and that you are just a hysterical woman…’ – Teresa Hughes, Meshies United.87
+
+‘So I went back to the consultant to discuss things. Unfortunately he is very pro mesh and when I asked if he thought my issues were linked to my TVT-O88 he actually screamed at me “you need to stop listening to the media and those bloody women, I fit hundreds of these every year and you’re the only person I’ve seen who is complaining and thinking you have problems”.’89
+
+A gynaecological cancer patient also felt disbelieved when she first reported her symptoms, but was later diagnosed with uterine leiomyosarcoma:Primary care and my experience with my GP was [ ], disappointing, to say the least; so many phone calls, me chasing, being dismissed. I called it medical gaslighting by the end, and I think the reason I ended up in tears with the final GP appointment was finally feeling vindicated, like I’m not a neurotic woman who’s making a fuss over nothing, which is definitely how I was made to feel.90
+
+Similarly, a woman who had experienced traumatic birth complications had her symptoms initially wrongly dismissed as psychological:One woman who was in extreme pain for the last few weeks of her pregnancy, had “anxious mother” recorded on her notes. In fact, she was bleeding internally as the result of spontaneous hemoperitoneum, a rare and often fatal complication of pregnancy whereby tissue had torn behind her uterus.91
+
+A woman who experienced severe pain during labour was also dismissed without her concerns being taken seriously:“I know I haven’t had a baby before but this is my body and I know what’s going on, and this doesn’t feel right, this doesn’t feel safe. I was expecting to be in pain, I’m not stupid, but this feels unsafe, this amount of pain; and being told, ‘you’ve never had a baby before, I don’t know what you expected”.92
+
+And a woman who experienced a missed recto vaginal fistula, causing personal care issues, was dismissed without her concerns being validated:After examining me the doctor informed me that I’d had a large baby and that had caused in her words “a baggy fanny”. To say I was upset is an understatement and despite telling her that I could tell the wind was coming from my back passage and passing through to the front, she said no further investigation was required.93
+
+These testimonies evidence some of the gendered tropes and negative stereotypes that may impact the care provided by some HCPs; tropes that might characterize women as: anxious94; overly emotional, irrational, or hysterical95; dramatic and prone to over-reaction96; precious97; and the cultural belief that women’s bodies, particularly Black women’s bodies, are built to experience and withstand a greater degree of pain.98 All patients quoted here arguably received a deflated level of credibility from their treating HCP than they otherwise would have, such that their testimonies were presumed to be unreliable and irrelevant. Each experienced testimonial injustice, which is suggestive of bias and prejudice against them as women.
+
+Indeed, framing the women as ‘hysterical’, ‘anxious’, ‘overreacting’, or the inference that their account of their symptoms was the product of some kind of ‘mass hysteria’ allowed the HCPs to explain away the symptoms the women sought help for. As we noted above, hysteria was once a common diagnosis for a variety of symptoms that women experienced (including those that we would now recognize as depression, anxiety, post-traumatic stress disorder, menopause, epilepsy, or infertility).99 And while hysterical neurosis no longer exists as a recognized diagnosis, it appears to be hard to escape the long shadow of women being cast as hysterical, emotional, and anxious, and the mischaracterization as psychological of the very real and physical problems they report. Gender stereotypes and biases, whether consciously or unconsciously held by the relevant HCPs in these examples, played a part in shaping the judgements they made about patients and the reliability of their testimonies, and the extent to which their patients were truly listened to.
+
+B. Racism
+
+In addition to gender, cultural biases, stereotypes, and racism together also function as one of the forms of identity prejudice underlying testimonial injustice in women’s healthcare.100 Identity is not one-dimensional and a person’s experience will be shaped by the way in which different factors intersect within broader power relationships and structures to affect access to and experiences of healthcare.101 In the UK, Black women are at 2.3 times greater risk of maternal mortality than White women, while Asian women have a risk of 1.3 times that of White women.102 Knight et al. reviewed the clinical records of 54 women in the UK who died during or up to a year after the end of pregnancy between 2009 and 2018, and found numerous health care system factors which they identified as ‘structural biases’ in the care provided.103 The biases were found to affect women from all ethnic groups who had ‘complex health and social problems’;104 nevertheless, they also identified biases affecting different ethnic groups more severely. Black women were particularly affected by a lack of individualized and nuanced care,105 and this was reflected in instances of testimonial injustice noted in the reports and evidence we considered.
+
+For example, a Black woman’s concerns about her foetus were denied and dismissed for hours, which ended up with her requiring surgery:“I ended up having to go into surgery because my daughter’s heartbeat had started to drop…I feel like we only got to this stage because the first midwife had dismissed me for hours when I was trying to…tell her that something is wrong.” (Black woman)106
+
+Pain management requests are also an area in which the global majority of women are subjected to prejudice on the basis of their ethnicity, with biased views about their supposed high or low tolerance levels for pain leading to the same outcome—insufficient provision of pain relief. One Black woman who provided evidence to the Birthrights inquiry was told ‘women like you’ do not need pain relief and was advised not to make so much noise.107 Conversely, many Asian women, particularly those of South-Asian heritage, referenced the ‘princess’ stereotype, and HCPs reported that women from these backgrounds were perceived as ‘precious’, less able to tolerate pain, and often ‘made a fuss’.108 Such prejudice in the area of pain relief is typified in the following examples:
+
+A Black woman who was struggling to breathe was dismissed and disbelieved when she reported her symptoms, but was later diagnosed with a pulmonary embolism:I was literally about to go home, there was a genuine 10 minute period between me going home with a potential embolism [and] it was just so weird, like the day before I remember constantly saying “my chest feels really tight, I can’t breathe, I can’t stand, I can’t walk, I can’t do anything”. I had to get a bed pan to pee in because I couldn’t stand for long without losing my breath and I’m like, you know I get it, I was anxious. But also, I genuinely couldn’t breathe, you know, and that’s the moment that always scares me because you hear so many of these stories, especially from Black women where their pain hasn’t been taken seriously during this crucial moment. […] My pain wasn’t taken seriously and I was dismissed to the point that could have actually, you know, cost me my life.109
+
+Other Black women reporting pain symptoms had their concerns minimized and written off:One Black mixed woman was told that she was being “dramatic” during administration of an epidural which subsequently resulted in numbness in her leg for the following three months.110
+
+Women reported often that their symptoms were minid and that their pain or worries about their baby were not taken seriously. For instance, one Black woman was told that she was “being loud for no reason”.111
+
+Similarly, a global majority woman had concerns about her baby dismissed, which she felt was due, in part, to her race:“During the postnatal stage, I was telling the nurses she wasn’t latching and was bringing up some yellow fluid. I was dismissed at first and then they assessed and took her to neonatal. There were too many incidents of not being taken seriously and my worries not being validated. I feel race probably played a part as I am a turban-wearing Sikh so look very different.”.112
+
+The above accounts illustrate how racial prejudice can lead to testimonial injustice. Again, all patients quoted here arguably received a deflated level of credibility from their treating HCP with their testimonies being reinterpreted through racialized stereotypes rather than being believed in the first instance. Complaints about pain, for example, were reframed as ‘being dramatic’ or ‘loud’—exemplifying the stereotype or trope of the ‘Angry Black Woman’113 and undermining the legitimacy of women’s self-report of pain. Similarly, the Sikh woman’s reflection that her visible religious identity probably contributed to her concerns being dismissed underscores how being perceived as other can exacerbate credibility deficits. These examples also illustrate how intersecting racial and gender prejudices place ethnic minority women at more acute risk of their testimonies being dismissed and disbelieved.
+
+The House of Commons Women and Equalities Committee has rightly stated that[t]he causes of the appalling disparity in maternal deaths are multiple, complex and still not fully understood. Fixating on any one cause risks over-simplifying the problem and placing blame on the very women who are most at risk.114
+
+Nevertheless, they, and others, have used the evidence provided by and on behalf of minority ethnic women about the failings in their healthcare to identify one of the bases for these failings and resulting harms as racism.115 While more needs to be done to explore and understand the causes and nature of this prejudice,116 the examples of care highlighted in recent reports demonstrate how racism in healthcare is embedded in the social and institutional structures of healthcare. Addressing these disparities requires more than attention to isolated care incidents; rather, it demands a critical examination of the organizational and cultural factors that consistently undermine the credibility of certain patients and perpetuate unequal treatment.117
+
+C. Testimonial injustice as a form of medical misogyny
+
+Having evidenced above the operation of gender and racial prejudice as distinct but intersecting drivers of testimonial injustice, we now consider how, taken together, they amount to a systemic phenomenon that we characterize as medical misogyny. In the context of women’s healthcare, whether women verbalize their distress and concerns to their HCPs, or there are clinical signs and symptoms which, in theory, provide a more objective and disinterested account of their condition, their narratives tell us that there is something stopping those involved in their care from not only hearing, but also actively listening to them. This, we suggest, is a form of medical misogyny. We distinguish here between hearing as a passive activity and listening, combining a taking in of information and understanding of meaning, together with the propensity to believe and be willing to act on it. The distress this can give rise to was noted in the Cumberlege report:[P]atients–almost universally women–spoke in disbelief, sadness and anger about the manner in which they were treated by the clinicians they had reached out to for help. The words ‘defensive’, ‘dismissive’ and ‘arrogant’, cropped up with alarming frequency. They spoke of being ‘gaslighted’ and of not being believed, particularly in relation to pelvic mesh and the suffering of pain.118
+
+Far from being an isolated problem with a few ‘bad apple’ HCPs, or a problem occurring in just one or two hospitals, the reports show that these care failings are endemic across the system of women’s healthcare, from research, to diagnostics, to care provision. In relation to maternity services in particular, the scale of patient safety failings was acknowledged by the Secretary of State for Health and Social Care, Wes Streeting, during an address at the Royal College of Obstetricians and Gynaecologists World Congress in June 2025. Announcing the launch of a national investigation into maternity and neonatal services, Streeting stated:we have to acknowledge that this has become systemic. It’s not just a few bad units up and down the country. Maternity units are failing. Hospitals are failing. Trusts are failing. Regulators are failing. There’s too much obfuscation, too much passing the buck and giving lip service, too much shrugging at a cultural problem that we fail to address.119
+
+The evidence of testimonial injustice in women’s healthcare in the NHS is further illustrated by data published by the UK government in 2022, which informed the first Women’s Health Strategy for England.120 For example, in response to the call for evidence to inform the Strategy, 84 per cent of nearly 100,000 survey participants121 reported that ‘there had been instances in which they had not been listened to by healthcare professionals’.122 This occurred not just during initial appointments to discuss medical problems, but across the life cycle of the provision of care, including during subsequent appointments, discussions about options for treatment, and follow-up care.123 Furthermore, according to a recent report by the Women and Equalities Commission on women’s reproductive health conditions, ‘a common theme in the evidence received was that of women’s pain being dismissed, not just due to a lack of understanding as to what might be causing it but because of a lack of empathy and “medical misogyny”’.124
+
+We suggest that testimonial injustice in women’s healthcare exemplifies this medical misogyny in that it embodies the entrenched and systematic devaluation of women’s voices and knowledge. Uncovering and understanding epistemic injustice in the context of women’s healthcare matters precisely because women are wrongfully excluded from contributing knowledge about their own bodies and experiences. This epistemic wrong has direct practical consequences for women’s health: accurate diagnosis and effective treatment depend fundamentally on healthcare professionals understanding patients’ experiences. When women’s testimony is systematically discredited, their symptoms may be misinterpreted, underlying conditions missed, and inappropriate treatments prescribed, leading to prolonged suffering and potentially serious health consequences—as we go on to demonstrate. This not only harms individual women but also impoverishes medical knowledge more broadly by systematically excluding women’s perspectives from healthcare discourse, perpetuating gaps in understanding of women’s health conditions.
+
+V. Epistemic injustice and patient harm
+
+For patients, the effect of their testimonies being ignored and disregarded may be devastating and the consequences far-reaching.125 This includes patients feeling (even more) vulnerable, an increase in the distance between HCP and patient in terms of the structural power relationship, and the preclusion of the possibility of shared decision-making in which the patient takes an active role in their care.126 When this type of testimonial harm is perpetrated, it also leads to an erosion of trust, which further threatens the therapeutic relationship. In this section, we consider examples of both primary and secondary harm, which the reports show can occur in women’s healthcare.
+
+A. The harms of testimonial injustice
+
+The reports discussed provide numerous examples of patients harmed as a result of their testimony being dismissed. The broad problem of primary harm is illustrated here:This “not being listened to” took several forms. We saw a pattern of women, particularly first-time mothers, being made to feel patronised and demeaned when their concerns were dismissed as overreactions and unnecessary anxieties based on “first-time nerves”. There were women whose concerns about the wellbeing of their unborn babies were ignored; and women on their second or later pregnancies whose personal knowledge, experience and understanding of their own bodies informed their convictions that something was wrong, but whose concerns were either ignored or dismissed. There were also women whose legitimate concerns about their newborn babies were not taken seriously.127
+
+Often, when patient concerns are ignored or dismissed in this way, more serious and tangible harm then occurs as a direct consequence. The following example illustrates how the primary harm (being undermined as an epistemic subject) means that crucial information that should have informed the treatment plan was disregarded, often causing (or almost causing) tangible, potentially serious, and even potentially fatal harm (secondary harms):I started to have a great pain, I felt the induction pain and I was screaming. Unfortunately, the midwife didn’t really believe me, she was like ‘how are you having the pain with you having an epidural?’ She didn’t believe me, she didn’t act as though she believed me and I was having great pain. Then after me screaming and shouting, they asked for the doctor to check my epidural and when he poured cold water on my legs, I felt it.128
+
+Other examples of primary harm include patients in early labour whose concerns were dismissed, and whose babies subsequently died.129 These cases represent testimonial injustice with the most severe consequences: when women’s knowledge of their own labour experiences is systematically discredited, the resulting epistemic wrong can lead to catastrophic harm. Moreover, all these are examples of avoidable harm, and so to improve understanding of how and why avoidable harm occurs, appreciating the impact of testimonial injustice is vital.
+
+As a result of failing to properly assess a patient’s condition, such a failure of care might also constitute a recognizable legal wrong, a possibility that carries damaging ramifications for individuals and organizations accused (as well as the victim). Harm caused by a breach of the professional standard of care might amount to negligence, with consequent damages paid to a successful claimant. Space prevents analysis of the challenges and impact of pursuing a negligence claim either for claimants or indeed the impact and resourcing burden placed on defendants, but it is worth noting that130 damages paid out diminish the funds available to provide good levels of staffing and other resources, which is likely to contribute to some of the problems, including the epistemic harms, identified in the reports we have studied. If the patient dies and the conduct involved is deemed to be grossly negligent, there may be criminal liability for gross negligence manslaughter.131 Police investigations were launched following the Ockenden review,132 and so criminal prosecutions might eventually follow. It is, however, questionable how far blaming individuals for gross negligence manslaughter serves to address the type of organizational failures discussed here, as Ost has observed in her analysis of the conviction of Dr Bawa Garba.133 Organizational criminal liability for corporate manslaughter would seem better suited, but the evidential burdens of corporate manslaughter make it difficult to prove.134 The Corporate Manslaughter and Corporate Homicide Act 2007 has been described by Menis as a ‘fiction of criminalisation’ that pays only lip service to public demands for justice,135 so the chances of organizational criminal liability seem low. What is clear, however, is that epistemic injustice is a wrong from which these legal consequences flow.
+
+These possible legal consequences highlight the serious wrong done to the victim, and might be seen to provide opportunities to address the injustice perpetrated. But all too often, justice will not be served because of the challenges of bringing a civil claim and/or the high evidential threshold for criminal liability. Crucially, understanding how epistemic injustice ultimately enables such harms could lead to more effective improvements in care, and a reduced clinical negligence bill which would in turn increase NHS resources to enable improved care. By addressing testimonial injustice directly, healthcare systems could reduce the risk of the catastrophic outcomes that may eventually trigger legal consequences.
+
+B. The consequential impact on patient trust
+
+A significant secondary consequence of epistemic injustice is the erosion of trust in HCPs and the organizations within which they work. Trust in healthcare incorporates the expectation that healthcare professionals will respect patient autonomy by listening to the patient’s account of their condition and symptoms to provide appropriate, beneficial care. When patient testimony is ignored or belittled, patients will understandably feel that they have been wronged as a primary harm. When that wrong also results in poor physical or mental outcomes, which might be consequential harms, such as that seen in the scandals we have discussed above, patient trust in the individual/s and the organization responsible for that harm will be severely damaged if not destroyed. The patient is likely to feel betrayed, and that betrayal and the direct erosion of trust is only the start. Mistrust is contagious. The family and friends of the person harmed might also experience a decline in trust in HCPs and organizations. When racism is present, entire communities lose trust.136 And when patient safety failings become a public matter because of a particularly tragic case or a scandal that is widely reported and discussed (such as the examples discussed above), societal fear of medical error and consequent mistrust of HCPs may also grow. On that basis, high-profile scandals may be particularly damaging to societal levels of trust in medicine.
+
+Wolfensberger and Wrigley’s exploration of trust is especially useful for our account of testimonial injustice.137 They suggest that uncertainty and risk are the most important features of trust. How the patient perceives the competence of the physician and the patient’s sense of the doctor’s commitment to a patient-oriented approach are crucial. When a patient’s account of their condition and the evidence about what is happening to their body is ignored, the patient will have good reason to doubt both the competence and the commitment of the HCP concerned. Where medicine is concerned, trust is relational and is a justifiable expectation (not a belief), founded on a cognitive mental state. Patients are constantly engaged in actively assessing those who care for them, rather than blindly trusting them from the outset,138 and so when important information provided by the patient is disregarded, the patient may reasonably doubt professional competence and will certainly question whether that professional is committed to a patient-oriented approach.
+
+The decline of trust damages the therapeutic relationship: patients may avoid seeking help, or will be more likely to question the advice and treatment offered, less likely to believe that the physician is acting in their best interests and less likely to follow the treatment plan, thus becoming a more ‘difficult patient’ in the eyes of the HCP and perpetuating the cycle of epistemic injustice. Evidence suggests that when women seeking healthcare are dismissed and not taken seriously, they may experience trauma and consequent fear of accessing necessary health services.139 This may obviously have dire consequences for the patient if they decide not to seek care or not to follow a treatment plan.
+
+Also, when testimonial injustice is present, the very notion of shared decision-making and an ‘honest two-way transfer of knowledge’ becomes impossible. If patient testimony is ignored, the patient is unable to share responsibility. Instead, they are expected to simply accept professional opinion in circumstances where they have every reason to question the competence and commitment of the HCP. What unites both dimensions of harm considered in this section (the legal consequences explored in Subsection A and the erosion of trust explored in subsection B) is the failure to listen. It is testimonial injustice, the systematic dismissal of women’s accounts of their own bodies and experiences, that creates the conditions for both the legal wrongs and the relational harms we have described. Understanding this is essential if healthcare systems and their regulators are to address not merely the symptoms of poor care, but its root cause.
+
+VI. Regulating to overcome epistemic injustice
+
+Our analysis reveals widespread and repeated harms to women caused to them in their healthcare as a result, we argue, of testimonial injustice. The question then arises as to what is needed from a regulatory perspective to prevent such avoidable harms.140 Here, we turn to the potential for appropriately formulated patient safety regulation to play a key role in avoiding harms to patients by highlighting and preventing the risk of epistemic injustice.141 In order to do this, we argue, it must also avoid the risk of perpetuating testimonial injustice itself.
+
+The scale of iatrogenic harm, ‘preventable adverse events resulting from medical therapy’,142 has long been a driver of harm prevention efforts in patient safety regulation across the globe.143 Learning lessons from such events and the implications for patients of failing to do so play a crucial role in such efforts in England.144 It has been increasingly emphasized in numerous public inquiry reports,145 and forms a central strand of the recommendations of those reports examined in this article.146 Government continues to accept that learning lessons from patient harm is critical to prevention efforts,147 with a resulting prevalence of this imperative throughout patient safety regulation strategies and frameworks.
+
+This commitment to learning from patient harm has recently taken on renewed urgency in maternity care, where the systemic failures discussed herein have prompted the most recent high-level government response—a national investigation of maternity and newborn care in 14 hospital trusts.148 The investigation, led by Baroness Amos, aims to put the voices of mothers and families at the heart of the work and is expected to report directly to the Health and Social Care Secretary, Wes Streeting, in the spring of 2026.149 In her interim report, she commented that, ‘nothing prepared me for the scale of unacceptable care that women and families have received, and continue to receive, the tragic consequences for their babies, and the impact on their mental, physical and emotional wellbeing’.150 Alongside this investigation, Streeting also announced a National Maternity and Neonatal Task Force, which he will chair personally, to help drive improvement across the NHS.151 As a priority, the Task Force will be responsible for answering ‘how can we ensure that women and their partners are always listened to when they raise concerns about their pregnancy or labour?’.152 He further announced a package of measures intended to increase accountability across the board and invoke the necessary cultural change, though further details on this are not yet clear.153
+
+While these recent announcements demonstrate continued government commitment to learning from patient safety failures, the effectiveness of such responses depends critically on their form, remit, and how they are implemented. A full account and analysis of all extant patient safety regulations and policies in England is not possible within this article,154 and so here we focus on two retrospective regulatory frameworks of particular relevance to women’s healthcare in England: the Maternity and Newborn Safety Investigation Programme (MSNI) and the Patient Safety Incident Response Framework (PSIRF). Each arises out of a particular patient safety strategy and has a specific regulatory body that applies a distinctive investigatory approach. Our focus on these frameworks allows us to illustrate that, while regulatory efforts are being made in patient safety regulation to respond to inquiry findings that patients are not being listened to, not basing such responses on the reasons why patients are not heard in their care, dooms them to failure and, worse, to the risk of replicating testimonial injustice themselves.
+
+MNSI’s purpose is ‘to provide independent, standardised and family focused investigations of maternity cases for families’, analysing key trends to ensure system-wide learning.155 It was established as one of the responses to the Safer Maternity Care national action plan, which sets out to achieve the National Maternity Safety Ambition of halving stillbirth and neonatal and maternal death rates and birth-related brain injuries by 2025.156 The Care Quality Commission (Maternity and Newborn Safety Investigation Programme) Directions 2023 (the 2023 Directions) have from 1 October 2023, required the CQC to carry out maternity investigations under MSNI.
+
+The 2023 Directions include duties on the CQC to consider concerns raised by mothers or family members in relation to their care or the care of their baby157 and to consult with and seek evidence from them as part of their investigation.158 Drafts of investigation reports, including a draft summary of the facts, must be given to the mother or her representatives or family, as well as the care providers concerned,159 giving them a reasonable time to consider it,160 and then taking into account any comments and making revisions where necessary.161 These steps suggest an acceptance that including patients as information providers in safety investigations can lead to a more fully informed understanding of the causes of harm. In addition, MSNI’s investigators have been provided with training sessions by Birthrights to help them to understand human rights and systemic racism in maternity care and potentially their own investigations, and to ‘instil a deeper appreciation for the lived realities of individuals who may face unique challenges within the healthcare system’.162 However, two problems remain that undermine MSNI’s likelihood of preventing patient harm.
+
+First, the regulation itself fails to require investigators explicitly to explore whether patients’ treatment has been affected by the prejudices underlying epistemic injustice in healthcare. Secondly, the qualifying criteria for cases that fall within the remit of the 2023 Directions and MSNI’s oversight are limited to those involving a baby or a direct or indirect maternal death.163 An eligible baby within the scheme has 37 or more completed weeks of gestation, and either died during birth (intrapartum stillbirth)164 or within the first week of life,165 or experienced a severe brain injury in the first week of life.166 Furthermore, it must be established that none of these outcomes is the result of a congenital or genetic abnormality.167 MSNI therefore covers important groups of patients who are evidently at risk of serious harm in their care. However, the strict eligibility criteria mean that many cases covered in the reports that we examined above would fall outside the jurisdiction of the MNSI inspectors who have been trained to be alert to at least some of the prejudices we have highlighted.
+
+Those patients who are not included within MSNI’s remit may fall within the purview of the PSIRF, which was piloted under England’s 2019 NHS Patient Safety Strategy, with a focus on understanding how incidents leading to patient harm happen. The Strategy was updated in 2021 to include an increased focus on addressing patient safety inequalities,168 and all NHS trusts were required to implement the PSIRF from September 2022.169 The PSIRF acknowledges that NHS organizations have found it challenging to conduct good quality investigations which contribute to learning and thus reduce the risk of harm to patients.170 It therefore provides guidance on how acute, ambulance, mental health, and community healthcare services should respond to a patient safety incident,171 and prioritises ‘compassionate engagement and involvement of those affected by patient safety incidents’.172
+
+A focus on the PSIRF allows us to highlight a further potential regulatory flaw, which is the risk that epistemic injustice will be perpetuated in investigations into the causes of patient harm. One of the PSIRF’s core elements following a patient safety incident is engaging and involving patients, families, and staff.173 This aims to ensure compassion and listening to all those involved. The Patient Safety Incident Response Standards174 state that engagement leads should communicate and engage with those involved in a positive and compassionate way175 and ‘listen and hear the distress of others in a measured and supportive way’.176 Those affected should be ‘meaningfully involved’.177 However, there is nothing within the framework to highlight to investigators the potential for epistemic exclusion of patients within the inquiry, or to help them to understand the potential contributions of epistemic injustice to the patient’s experience of their healthcare. While some patients will be listened to under the PSIRF, there is no reason to suspect that those conducting investigations within its purview are exempt from the prejudices patients can be subject to in the course of their care. Without an explicit embedding of a knowledge of the existence and harms of epistemic injustice, there is a risk that patients will not be seen as epistemically credible by investigators, and thus not truly heard in the sense of contributing to a full account of the causes and effects of their poor experiences.
+
+While the MNSI and PSIRF are fundamentally important regulatory provisions in attempting to learn from harm and improve future care for women and persons of female biology, they are only two out of a plethora of patient safety initiatives.178 Here, they serve as examples of the ways in which regulation that is not based on a knowledge and understanding of epistemic injustice in this context will fail to that ensure lessons are learned, meaning that the epistemic harms already experienced by patients may be perpetuated.
+
+The regulatory approaches noted here indicate an understanding at the policy level that learning from error is a key patient safety tool because, if there is no understanding of how harm is caused, prevention efforts cannot be targeted effectively. They also illustrate a commitment to implementing patient safety regulation, which ostensibly responds to inquiry findings that patients should be listened to, by involving them in PSIRF or MSNI investigations. However, current approaches are destined to hear but not listen due to the absence of a crucial element—an understanding of testimonial injustice as a critical risk factor in women’s healthcare.
+
+VII. Conclusion
+
+As we have demonstrated above, extensive evidence of testimonial injustice permeates all areas of women’s healthcare. This epistemic marginalization directly correlates with missed opportunities for learning, inadequate investigations, and poor care outcomes, sometimes with devastating consequences. It is becoming increasingly recognised that understanding the intersecting factors that lead to disparities in healthcare is essential to effectively tackling and overcoming them.179 Patients consistently report that they want to be listened to, both about the care they would like to receive and regarding the management of adverse events. Indeed, in 2016, the Better Births review noted that ‘women wanted to be listened to about what they want for themselves and their baby, and to be taken seriously when they raise concerns’.180 The maternity context is not alone in this recognition.181
+
+Yet, the policy response to this issue has to be more than a recognition that HCPs need to listen to women.182 Crucially, our concern is that typical approaches to addressing these failures—primarily recommendations calling for the establishment of a culture of compassion and kindness in care or repeated assertions that patients should be listened to—are inadequate because they fail to address the underlying epistemic structures that position women as unreliable narrators of their own experiences. Such approaches assume that failures of this nature are isolated either to specific healthcare contexts, for example, maternity care, or isolated to specific hospitals or personnel, and this fundamentally ignores the structural patterns that routinely devalue women’s knowledge and experiences across the whole sector of women’s healthcare.
+
+It is important to emphasize that this article is not a call for regulation to implement mechanisms of assigning blame to individual HCPs, as it is evident that this is detrimental to learning in the aftermath of error.183 Rather, this article calls for regulatory and educational responses grounded in a nuanced understanding of epistemic injustice, and further work will be required to explore what such interventions may involve. Such interventions likely must extend beyond regulatory reform alone. Medical culture and the ‘hidden curriculum’184—the informal transmission of values, assumptions, and stereotypes that occurs alongside formal clinical training—play a significant role in perpetuating the epistemic harms we have identified by embedding unexamined biases about women’s credibility in new generations of clinicians. Addressing testimonial injustice in women’s healthcare, therefore requires cultural and educational change within medical institutions. Both the healthcare system and its regulators must recognize and actively counter the systematic devaluation of women’s testimonial knowledge. Only by acknowledging these epistemic wrongs can we begin to address the issues that systematically undermine women’s health outcomes. Without this fundamental reframing, regulatory responses risk perpetuating the very prejudices they seek to address.
+
+Acknowledgements
+
+The authors would like to thank Professor Sara Fovargue for her invaluable advice and insightful comments on an earlier draft of this article. We are also very grateful for the feedback from participants at the Socio-Legal Studies Association Conference, University of Portsmouth, 2024 and from members of the Health Law Research Group at the University of Sheffield.
+
+Footnotes
+
+Funding
+
+This work was supported by Wellcome (grant no: 222858/Z/21/Z); and partially funded by the University of Manchester School of Social Sciences Recovery Support Grant 2021/22.
+
+Conflicts of interest. None declared.
+
+1 See NHS, ‘Women’s Health’ (n.d) <https://www.nhs.uk/womens-health/> accessed 20 June 2025.
+
+2 We acknowledge that trans men and non-binary people also access these healthcare services. We use gendered language in this article to discuss specific prejudices against and stereotypes of women that we suggest are relevant to the way that they are perceived and treated making them particularly vulnerable to epistemic injustice. However, trans-identifying and non-binary people may also be particularly vulnerable to epistemic injustice owing to prejudice against their specific identities as trans and non-binary individuals.
+
+3 Department of Health and Social Care, Women’s Health Strategy for England (Cm 736, 2022).
+
+4 ibid 2.
+
+5 ibid 6.
+
+6 J Cumberlege, ‘First Do No Harm – The Report of the Independent Medicine and Medical Devices Safety Review’ (the Cumberlege Report) (2020) <https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf> accessed 20 June 2025.
+
+7 D Ockenden, ‘Findings, Conclusions and Essential Actions from the Independent Review of Maternity Services at The Shrewsbury and Telford Hospital NHS Trust’ (2022) <https://www.ockendenmaternityreview.org.uk/wp-content/uploads/2022/03/FINAL_INDEPENDENT_MATERNITY_REVIEW_OF_MATERNITY_SERVICES_REPORT.pdf> accessed 23 June 2025.
+
+8 Birthrights, ‘Systemic Racism Not Broken Bodies – An Inquiry into Racial Injustice and Human Rights in UK Maternity Care’ (2022) <https://www.birthrights.org.uk/wp-content/uploads/2022/05/Birthrights-inquiry-systemic-racism-May-22-web-1.pdf> accessed 23 June 2025.
+
+9 M Peter and R Wheeler, ‘The Black Maternity Experiences Survey A Nationwide Study of Black Women’s Experiences of Maternity Services in the United Kingdom – Five X More’ (2022) <https://fivexmore.org/blackmereport> accessed 20/06/2025. And see their 2025 report at < https://fivexmore.org/black-maternity-experiences-report-2025> accessed 23 February 26.
+
+10 B Kirkup, ‘Reading the Signals – Maternity and Neonatal Services in East Kent – The Report of the Independent Investigation’ HC 681 (2022) <https://assets.publishing.service.gov.uk/media/634fb083e90e0731a5423408/reading-the-signals-maternity-and-neonatal-services-in-east-kent_the-report-of-the-independent-investigation_print-ready.pdf> accessed 20 June 2025.
+
+11 Welsh Parliament, Health and Social Care Committee, ‘Unheard: Women’s Journey Through Gynaecological Cancer’ (2023) <https://senedd.wales/media/5ztjb5fm/cr-ld16197-e.pdf> accessed 20 June 2025.
+
+12 K Thomas, ‘Listen to Mums: Ending the Postcode Lottery on Perinatal Care A report by The All-Party Parliamentary Group on Birth Trauma’ (2024) <https://www.theo-clarke.org.uk/sites/www.theo-clarke.org.uk/files/2024-05/Birth%20Trauma%20Inquiry%20Report%20for%20Publication_May13_2024.pdf> accessed 20 June 2025.
+
+13 Cumberlege (n 6) ii, 2, 17–21, 140; Ockenden (n 7) 14, 107, 116, 133, 193; Birthrights (n 8) 37, 49, 52–55, 66–67; Peter and Wheeler (n 9) 23–24; Kirkup (n 10) 1–8, 20–22, 36–37, 39–52, 62–67, 159–60; Welsh Parliament (n 11) 17–23; Thomas (n 12) 8, 14–15, 32, 65–66.
+
+14 A number of the reports we considered also highlighted the challenges for healthcare staff in attempting to provide safe care for women, and their own struggles to be heard where they felt that this was not happening. This important issue is acknowledged here, but space does not permit a full consideration of it.
+
+15 See eg Cumberlege (n 6) which details the chronic pain pelvic mesh patients have experienced. See Ockenden (n 7), at para 2.4 where reported cases of maternal and neonatal harm are stated to include: cases of stillbirth, neonatal death, maternal death, hypoxic ischaemic encephalopathy (HIE) (grades 2 and 3) and other complications in mothers and newborn babies. See Kirkup (n 10) 6–8 where an illustrative case of harm to a patient’s wellbeing resulting from a failure to listen and to respond compassionately is outlined. See also Welsh Parliament (n 11), at para 15–16 where the story of Judith, a woman whose terrible pain and concerns that her cancer had returned were ignored. By the time she was diagnosed, Judith’s cancer was incurable, and she died shortly after her video evidence was shown in Committee.
+
+16 Department of Health and Social Care (n 3).
+
+17 HC Deb 30 January 2025, vol 761, col 428.
+
+18 Department of Health and Social Care (n 3) 8.
+
+19 Women and Equalities Committee, Women’s Reproductive Health Conditions (HC 24-25, 337-I).
+
+20 See eg Department of Health, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol (Cmd 5207(I), 2001); R Francis, ‘The Mid Staffordshire NHS Foundation Trust. Public Inquiry Chaired by Robert Francis QC. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry’, 3 vols, (2013) <https://www.gov.uk/government/publications/independent-inquiry-into-care-provided-by-mid-staffordshire-nhs-foundation-trust-january-2001-to-march-2009> accessed 20 July 2025; National Advisory Group on the Safety of Patients in England, ‘A Promise to Learn – A Commitment to Act: Improving the Safety of Patients in England’ (2013) <https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/226703/Berwick_Report.pdf> accessed 20 July 2025.
+
+21 M Fricker, Epistemic Injustice: Power and the Ethics of Knowing (OUP 2007) 1 (author’s own emphasis).
+
+22 V May, ‘Speaking into the Void? Intersectionality Critiques and Epistemic Backlash’ (2014) 29 Hypatia 94; G Polhaus Jr, ‘Varieties of Epistemic Injustice’ in IJ Kidd, J Medina and G Pohlhaus Jr, The Routledge Handbook of Epistemic Injustice (Routledge 2017) 37–40.
+
+23 Polhaus Jr, ibid,37.
+
+24 CK Gott, Experience, Identity and Epistemic Injustice within Ireland’s Magdalene Laundries (Bloomsbury 2023) 22.
+
+25 May (n 22) 98; Polhaus Jr (n 22) 37; J Medina, ‘Feminism and Epistemic Injustice’ in KQ Hall and Ásta (eds), The Oxford Handbook of Feminist Philosophy (OUP 2021) 409.
+
+26 Fricker (n 21).
+
+27 ibid 22.
+
+28 ibid 136.
+
+29 Fricker (n 21) 17.
+
+30 ibid 130–31.
+
+31 ibid.
+
+32 ibid 154–59, 169–70.
+
+33 ibid 152–61 (s 7.2).
+
+34 ibid 149–52.
+
+35 ibid; building on this concept for a discussion of rape myths and domestic abuse as hermeneutical injustices see also K Jenkins, ‘Rape Myths and Domestic Abuse as Hermeneutical Injustices’ (2017) 34 Journal of Applied Philosophy 191.
+
+36 ibid; H Carel and IJ Kidd, ‘Epistemic Injustice in Medicine and Healthcare’ in IJ Kidd, J Medina and G Polhaus Jr (eds), The Routledge Handbook of Epistemic Injustice (Routledgen 2017).
+
+37 This focus is due to space constraints and should not be taken to indicate that hermeneutical injustice is not a feature of healthcare in this context.
+
+38 Fricker (n 21) 35.
+
+39 ibid 23–27.
+
+40 Kathy’s story was originally reported in 2015 by the then active news site ThinkProgress, see ThinkProgress, ‘When Gender Stereotypes Become a Serious Hazard to Women’s Health’ <https://archive.thinkprogress.org/when-gender-stereotypes-become-a-serious-hazard-to-womens-health-f1f130a5e79/> accessed 20 June 2025. It also featured in C Criado Perez, Invisible Women – Exposing Data Bias in a World Designed for Men (Chatto and Windus 2019) 223–24.
+
+41 ibid.
+
+42 ibid.
+
+43 ibid.
+
+44 Fricker (n 21) 43–44.
+
+45 ibid 43.
+
+46 ibid 44.
+
+47 ibid.
+
+48 ibid 46–48.
+
+49 ibid.
+
+50 ibid 47–48.
+
+51 L Merone and others, ‘"I just want to feel safe going to a doctor" Experiences of female patients with chronic conditions in Australia’ (2022) 3 Women’s Health Reports: ‘I Just Want to Feel Safe Going to a Doctor’: Experiences of Female Patients with Chronic Conditions in Australia | Women’s Health Reports.
+
+52 See, eg N Tuana, ‘The Speculum of Ignorance: The Women’s Health Movement and Epistemologies of Ignorance’ (2006) 21 Hypatia 1; H Carel and IJ Kidd, ‘Epistemic Injustice in Healthcare: A Philosophical Analysis’ (2014) 17 Medicine, Health Care and Philosophy 529; L Freeman, ‘Confronting Diminished Epistemic Privilege and Epistemic Injustice in Pregnancy by Challenging a “Panoptics of the Womb”‘(2015) 40 Journal of Medicine and Philosophy 44; IJ Kidd and H Carel, ‘Epistemic Injustice and Illness’ (2017) 34 Journal of Applied Philosophy 172; C Blease, H Carel and K Geraghty, ‘Epistemic Injustice in Healthcare Encounters: Evidence from Chronic Fatigue Syndrome’ (2017) 43 Journal of Medical Ethics 549; EA Byrne, ‘Striking the Balance with Epistemic Injustice in Healthcare: The Case of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis’ (2020) 23 Medicine, Health Care and Philosophy’ 371; R Lakeman, ‘Epistemic Injustice and the Mental Health Service User’ (2010) 19 International Journal of Mental Health Nursing 151; P Crichton, H Carel and IJ Kidd, ‘Epistemic Injustice and Psychiatry’ (2017) 41 BJ Psych Bull 65; AP Scrutton, ‘Epistemic Injustice and Mental Illness’ in IJ Kidd, J Medina and G Polhaus Jr (eds), The Routledge Handbook of Epistemic Injustice (Routledge 2017); L Bortolotti (ed), Epistemic Injustice in Mental Healthcare – Recognising Agency and Promoting Virtues Across the Life Span (Springer Nature 2025); Y Peled, ‘Language Barriers and Epistemic Injustice in Healthcare Settings’ (2018) 32 Bioethics 360; A Younas, ‘Epistemic Injustice in Health Care Professionals and Male Breast Cancer Patients Encounters’ (2021) 31 Ethics & Behaviour 451.
+
+53 Carel and Kidd, ‘Epistemic Injustice in Medicine and Healthcare’ (n 36) 336.
+
+54 ibid.
+
+55 ibid.
+
+56 ibid.
+
+57 ibid; LT Rosen, ‘Mapping out Epistemic Justice in the Clinical Space: Using Narrative Techniques to Affirm Patients as Knowers’ (2021) 16 Philosophy, Ethics and Humanities in Medicine 1; Kidd and Carel, ‘Epistemic Injustice and Illness’ (n 52); Scrutton (n 52).
+
+58 L Nimmon and T Stenfors-Hayes, ‘The “Handling” of Power in the Physician–patient Encounter: Perceptions from Experienced Physicians’ (2016) 16 BMC Medical Education 114; See also M Foucault, The Birth of the Clin (AM Sheridan-Smith tr, Routledge 2003); JP Bishop, ‘Revisiting Foucault’ (2009) 34 Journal of Medicine and Philosophy 323.
+
+59 NHS, ‘NHS Long Term Plan – 1. Empowering People’ (n.d.) <https://www.longtermplan.nhs.uk/online-version/chapter-5-digitally-enabled-care-will-go-mainstream-across-the-nhs/1-empowering-people/> accessed 20 May 2025; P Bravo and others, ‘Conceptualising Patient Empowerment: A Mixed Methods Study’ (2015) 15 BMC Health Services Research 252.
+
+60 Bravo and others, ibid; M Boudioni, S McLaren and G Lister, ‘A Critical Analysis of National Policies, Systems, and Structures of Patient Empowerment in England and Greece’ (2017) 11 Patient Preference and Adherence 1657.
+
+61 Nimmon and Stenfors-Hayes (n 58) 7.
+
+62 Carel and Kidd, ‘Epistemic Injustice in Healthcare: A Philosophical Analysis’ (n 52) 530.
+
+63 ibid 536.
+
+64 Kidd and Carel, ‘Epistemic Injustice and Illness’ (n 52) 175.
+
+65 Examples of chronic somatic conditions include chronic fatigue syndrome, fibromyalgia, and irritable bowel syndrome.
+
+66 ibid.
+
+67 Rosen (n 57).
+
+68 Kidd and Carel, ‘Epistemic Injustice and Illness’ (n 52) 177.
+
+69 ibid 177–78.
+
+70 L O’Donovan, ‘Listen[ing] to Mums: Epistemic Injustice in UK Maternity Care’ (The Polyphony, 14 February 2025) <https://thepolyphony.org/2025/02/14/listening-to-mums/> accessed 17 January 2026.
+
+71 ibid.
+
+72 R Chung, ‘Structural Health Vulnerability: Health Inequalities, Structural and Epistemic Injustice’ (2021) 52 Journal of Social Philosophy 201.
+
+73 Kidd and Carel, ‘Epistemic Injustice and Illness’ (n 52) 178.
+
+74 eg on women’s pain not being believed see Ipsos, ‘Hysterical Health – Unpicking the Cultural Beliefs that Shape Women’s Healthcare’ (2023) <https://www.ipsos.com/en-uk/hysterical-health-unpicking-cultural-beliefs-that-shape-womens-healthcare> accessed 20 June 2025.
+
+75 R Auchmuty, ‘Feminist Approaches to Sexuality and Law Scholarship’ (2015) 15 Legal Information Management 4, 6 (author’s own emphasis).
+
+76 E Cleghorn, ‘Medical Myths about Gender Roles go back to Ancient Greece. Women are Still Paying the Price Today’ TIME (New York, 17 June 2021) <https://time.com/6074224/gender-medicine-history/> accessed 20 May 2025; E Cleghorn, Unwell Women – A Journal through Medicine and Myth in a Man-Made World (Weidenfeld & Nicolson 2021).
+
+77 ibid.
+
+78 ibid.
+
+79 JB Bonnard, ‘Male and Female Bodies According to Ancient Greek Physicians’ (LE Doherty and VS Cuchet trs) (2013) 37 Women, Gender, History 1.
+
+80 Cleghorn (n 76).
+
+81 ibid.
+
+82 C Tasca and others, ‘Women and Hysteria in the History of Mental Health’ (2012) 19 Clinical Practice & Epidemiology in Mental Health 110; M Trimble and EH Reynolds, ‘A Brief History of Hysteria: From the Ancient to the Modern’ (2016) 139 Handbook of Clinical Neurology 3.
+
+83 ibid 116.
+
+84 EC Romanis and others, ‘Reviewing the Womb’ (2021) 47 JME 820.
+
+85 L Merone and others, ‘Sex Inequalities in Medical Research: A Systematic Scoping Review of the Literature’ (2022) 3 Women’s Health Reports 49, 49–50.
+
+86 eg it takes on average eight years for patients to receive a diagnosis of endometriosis. See All Party Parliamentary Group on Endometriosis, ‘Endometriosis in the UK – Time for Change’ (2020) <https://www.endometriosis-uk.org/sites/default/files/files/Endometriosis%20APPG%20Report%20Oct%202020.pdf> accessed 20 July 2025.
+
+87 Cumberlege (n 6) 20.
+
+88 TRANS vaginal tape–obturator.
+
+89 Cumberlege (n 6), 151.
+
+90 Welsh Parliament, Health and Social Care Committee (n 11), 17.
+
+91 Thomas (n 12) 14.
+
+92 Kirkup (n 10), 44.
+
+93 Ockenden (n 7).
+
+94 Ipsos (n 74); DE Hoffman and AJ Tarzian, ‘The Girl Who Cried Pain: A Bias against Women in the Treatment of Pain’ (2001) 29 Journal of Law, Medicine & Ethics 13; Criado-Perez (n 40).
+
+95 Hoffman and Tarzian, ibid; A Samulowitz and others, ‘“Brave Men” and “Emotional Women”: A Theory Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain’ (2018) 1 Pain Research and Management 1; G Jackson, Pain and Prejudice: A Call to Arms for Women and their Bodies (Piatkus 2019); Criado-Perez (n 40); Cleghorn (n 76).
+
+96 ibid.
+
+97 Birthrights (n 8) 58, 63.
+
+98 Hoffman and Tarzian (n 94); Ipsos (74) 11; Cleghorn (n 76); L Zhang and others, ‘Gender Biases in Estimation of Others Pain’ (2021) 22 Journal of Pain 1048.
+
+99 Cleghorn (n 76); Jackson (n 95); L Appignanesi, Mad, Bad and Sad: A History of Women and the Mind Doctors from 1800 to the Present (Hachette 2008); JM Usher, The Madness of Women - Myth and Experience (Routledge 2011) 812; A Scull, Hysteria – The Disturbing History (OUP 2012).
+
+100 Women and Equalities Committee, Black Maternal Health (2022–23, HC 94-III); Z Khan, ‘Ethnic Health Inequalities in the UK’s Maternity Services: A Systematic Literature Review’ (2021) 29 British Journal of Midwifery 100.
+
+101 R Samra and O Hankivsky, ‘Adopting an Intersectionality Framework to Address Power and Equity in Medicine’ (2021) 397 Lancet 857.
+
+102 A Felker, R. Patel, R Kotnis, S Kenyon, and M. Knight (eds), on behalf of MBRRACE-UK, Saving Lives, Improving Mothers’ Care Compiled Report - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2021-23, (2025) Oxford: National Perinatal Epidemiology Unit, University of Oxford < https://www.npeu.ox.ac.uk/mbrrace-uk/reports/maternal-reports/maternal-report-2021-2023> accessed 23 February 2026.
+
+Allison Felker, Roshni Patel, Rohit Kotnis, Sara Kenyon, and Marian Knight (eds) on behalf of MBRRACE-UK. Saving Lives, Improving Mothers’ Care Compiled Report - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2020-22. Oxford: National Perinatal Epidemiology Unit, University of Oxford (October 2024) <https://www.npeu.ox.ac.uk/mbrrace-uk/reports/maternal-reports/maternal-report-2020-2022> accessed 7 July 2025.
+
+103 M Knight and others, on behalf of MBRRACE-UK, ‘A National Cohort Study and Confidential Enquiry to Investigate Ethnic Disparities in Maternal Mortality’ (2021) 43 eClinicalMedicine 101237.
+
+104 ibid 12.
+
+105 ibid.
+
+106 Peter and Wheeler (n 9) 23.
+
+107 Birthrights (n 8) 63.
+
+108 ibid 22, 52, 58–59, 63.
+
+109 ibid 47.
+
+110 Peter and Wheeler (n 9) 23.
+
+111 ibid.
+
+112 Birthrights (n 8) 53.
+
+113 T Jones and KJ Norwood, ‘Aggressive Encounters & White Fragility: Deconstructing the Trope of the Angry Black Woman’ (2017) 102 Iowa Law Review 2017.
+
+114 Women and Equalities Committee (n 100) 11.
+
+115 Knight and others (n 103), 13; Birthrights (n 8); Women and Equalities Committee (n 100).
+
+116 PA Braveman and others, ‘Systemic and Structural Racism: Definitions, Examples, Health Damages, and Approaches to Dismantling’ (2022) Health Affairs 41 171–78.
+
+117 PA Braveman and others, ‘Systemic and Structural Racism: Definitions, Examples, Health Damages, and Approaches to Dismantling’ (2022) Health Affairs 41 171–78.
+
+118 Cumberlege (n 6) 7.
+
+119 Department of Health and Social Care and The Rt Hon Wes Streeting MP, ‘Health and Social Care Secretary Speech at RCOG World Congress’ (23 June 2025) <https://www.gov.uk/government/speeches/health-and-social-care-secretary-speech-at-rcog-world-congress> accessed 01 July 2025.
+
+120 Department for Health and Social Care (n 3).
+
+121 ibid 2, 15.
+
+122 ibid 15.
+
+123 ibid.
+
+124 Women and Equalities Committee (n 19) 21.
+
+125 ibid.
+
+126 ibid.
+
+127 Kirkup (n 10) 43.
+
+128 Birthrights (n 8) 54.
+
+129 Ockenden (n 7) 104.
+
+130 Annual Statistics from NHS Resolution: Annual statistics—NHS Resolution And see; NHS facing £27bn bill for maternity failings in England | The Independent.
+
+131 C Dyer, ‘First Case of Corporate Manslaughter against NHS Collapses’ (2016) 352 BMJ i585.
+
+132 A Patel, ‘Police Reviewing more than 100 Maternity Cases’ BBC News (21 November 2024) <https://www.bbc.co.uk/news/articles/cpwre51d22yo> accessed 7 July 2025.
+
+133 S Ost, ‘Drs Bramhall and Bawa-Garba and the Rightful Domain of the Criminal Law’ (2019) 45 Journal of Medical Ethics 3, 151–55.
+
+134 A Patel, ‘Police Reviewing more than 100 Maternity Cases’ BBC News (21 November 2024) <https://www.bbc.co.uk/news/articles/cpwre51d22yo> accessed 7 July 2025.
+
+135 S Menis, ‘The Fiction of the Criminalisation of Corporate Killing’ (2017) 81 Journal of Criminal Law 467–77.
+
+136 See, eg S Hamad H. Bradby, B. Maina-Ahlberg et al.and others, ‘Racism in Healthcare: A Scoping Review’ (2022) 22 BMC Public Health 988.
+
+137 M Wolfensberger and A Wrigley, Trust in Medicine (CUP 2019), chapter 11. The authors suggest that such betrayal has a moral component. Other work is broadly relevant to trust in medicine but less so to testimonial injustice, see, eg Z Fritz and R Holton, ‘Too Much Medicine: Not Enough Trust?’ (2019) 45 Journal of Medical Ethics 31; CC Clark, ‘Trust in Medicine’ (2002) 27 Journal of Medicine and Philosophy 11.
+
+138 Wolfensberger and Wrigley, ibid 120.
+
+139 L Merone and others, ‘“I just want to feel safe going to a doctor” Experiences of Female Patients with Chronic Conditions in Australia’ (2022) 3 Women’s Health Reports: ‘I Just Want to Feel Safe Going to a Doctor’: Experiences of Female Patients with Chronic Conditions in Australia | Women’s Health Reports
+
+140 Patient Safety Learning, ‘Mind the Implementation Gap: The Persistence of Avoidable Harm in the NHS’ (2022) <https://d2z1laakrytay6.cloudfront.net/Mindtheimplementationgap_ThepersistenceofavoidableharmintheNHS_2022-04-07-121554_vhao.pdf> accessed 7 July 2025. For more on the efficacy or otherwise of public inquiries, see National Audit Office, Investigation into Government-Funded Inquiries (HC 2017–19, 836); Institute for Government, ‘How Public Inquiries can Lead to Change’ (2017) <https://www.instituteforgovernment.org.uk/sites/default/files/publications/Public Inquiries %28final%29.pdf> accessed 7 July 2025; Statutory Inquiries Committee, Public Inquiries: Enhancing Public Trust (HL 2024-25, 9).
+
+141 We focus on mechanisms within England to do so, but our arguments apply to patient safety regulation more generally. This is also not to say that other initiatives such as combatting the transmission of established prejudices in clinical training should not also be undertaken, see H Carel and IJ Kidd, ‘Epistemic Injustice in Medicine and Healthcare’ in IJ Kidd, J Medina and G Polhaus Jr (eds), The Routledge Handbook of Epistemic Injustice (Routledge 2017)) and C Lawrence and others, ‘The Hidden Curricula of Medical Education: A Scoping Review’ (2018) Academic Medicine 93 648–56.
+
+142 A Merry and W Brookbanks, Merry and McCall Smith’s Error’s, Medicine and the Law (2nd edn, CUP 2017) 55 (emphasis in original).
+
+143 S Devaney, ‘Errors, Medicine and the Law: Learning Lessons about how to Learn from Mistakes in Healthcare’ in S Fovargue and C Purshouse, Leading Works in Health Law and Ethics (Routledge 2024).
+
+144 Department of Health, ‘An Organisation with a Memory: Report of an Expert Group on Learning from Adverse Events in the NHS Chaired by the Chief Medical Officer’ (2000) <https://psnet.ahrq.gov/issue/organisation-memory-report-expert-group-learning-adverse-events-nhs-chaired-chief-medical> accessed 7 July 2025.
+
+145 Department of Health, The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol (Cm 5207, 2001); National Advisory Group on the Safety of Patients in England, ‘A Promise to Learn – A Commitment to Act: Improving the Safety of Patients in England’ (2013) <https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/226703/Berwick_Report.pdf> accessed 7 July 2025; R Francis, ‘Freedom to Speak Up. An Independent Review into Creating an Open and Honest Reporting Culture in the NHS’ (2015) <http://freedomtospeakup.org.uk/wp-content/uploads/2014/07/F2SU_web.pdf> accessed 7 July 2025, and B Kirkup, ‘The Report of the Morecombe Bay Investigation’ (2015) <https://assets.publishing.service.gov.uk/media/5a7f3d7240f0b62305b85efb/47487_MBI_Accessible_v0.1.pdf> accessed 7 July 2025.
+
+146 Cumberlege (n 6) 49, 184; Ockenden (n 7) 5–6, 39–41, 54; Birthrights (n 8) 91; Peter and Wheeler (n 96) 4, 36, 40; Kirkup (n 10) 162–63; Thomas (n 12) 66.
+
+147 Department of Health, Learning not Blaming: The government response to the Freedom to Speak Up Consultation, the Public Administration Select Committee Report ‘Investigating Clinical Incidents in the NHS’, and the Morecambe Bay Investigation (Cm 9113, 2015).
+
+148 Department of Health and Social Care, ‘14 NHS trusts the focus of national maternity investigation’ (15 September 2025) <https://www.gov.uk/government/news/14-nhs-trusts-the-focus-of-national-maternity-investigation> accessed 1 September 2025.
+
+149 ibid.
+
+150 Amos V, Independent Investigation into Maternity and Neonatal Services in England—Reflections and Initial Impressions (December 202 <https://www.matneoinv.org.uk/updates/independent-investigation-into-maternity-and-neonatal-services-in-england-reflections-and-initial-impressions/> accessed 23 February 2026.
+
+151 Department of Health and Social Care (n 119).
+
+152 ibid.
+
+153 ibid.
+
+154 For non-maternity patient safety initiatives, see details of all initiatives at NHS England, ‘Patient Safety’ <https://www.england.nhs.uk/patient-safety/> accessed 7 July 2025. In the maternity sector see eg NHS England, ‘Three Year Delivery Plan for Maternity and Neonatal Services’ (2023) <https://www.england.nhs.uk/wp-content/uploads/2023/03/B1915-three-year-delivery-plan-for-maternity-and-neonatal-services-march-2023.pdf> accessed 7 July 2025; the initiatives outlined in E Parkin, B Balogun and R Harker, ‘House of Commons Library Research Briefing: Quality and safety of maternity care (England)’ (6 March 2024) <https://researchbriefings.files.parliament.uk/documents/CBP-9815/CBP-9815.pdf> accessed 7 July 2025; and those contained in Department of Health and Social Care, ‘Government Response to Reading the Signals: Maternity and Neonatal Services in East Kent–the report of the Independent Investigation’ (August 2023) <https://www.gov.uk/government/publications/maternity-and-neonatal-services-in-east-kent-report-government-response> accessed 7 July 2025.
+
+155 Maternity and Newborn Safety Investigations, ‘Our Governance’ (n.d) <https://www.mnsi.org.uk/about/our-governance/> accessed 7 July 2025.
+
+156 Department of Health, ‘Safer Maternity Care: Next Steps Towards the National Maternity Ambition’ (October 2016) <https://assets.publishing.service.gov.uk/media/5a80efa3ed915d74e33fd3d7/Safer_Maternity_Care_action_plan.pdf> accessed 7 July 2025. Note that the Plan is unlikely to achieve the Ambition within that timeframe–see B Balogun and others, Quality and Safety of Maternity Care (England) (2025) <https://commonslibrary.parliament.uk/research-briefings/cbp-9815/> accessed 7 July 2025.
+
+157 Direction 2 (4)(d). Direction 2 (4)(e) requires the CQC to consider concerns raised by anyone involved in the care under investigation, and anyone else it thinks appropriate.
+
+158 Direction 5.
+
+159 Direction 4(2).
+
+160 Direction 4(3).
+
+161 Direction 4(4).
+
+162 MNSI, ‘Inspiring Inclusion and Empowering MNSI Investigators’ (2024) <https://www.mnsi.org.uk/news/inspiring-inclusion-and-empowering-mnsi-investigators/> accessed 7 July 2025.
+
+163 para 3(1) of the Schedule sets out that maternal deaths fall within these directions if occurring ‘within 42 days of the end of the pregnancy from any cause related to or aggravated by the pregnancy or its management, but not from accidental or incidental causes’.
+
+164 para 2(1)(a).
+
+165 para 2(1)(b).
+
+166 para 2(2).
+
+167 para 2(1)(b).
+
+168 NHS, ‘NHS Patient Safety Strategy: 2021 Update’ (2021) <https://www.england.nhs.uk/wp-content/uploads/2021/02/B0225-NHS-Patient-Safety-Strategy-update-Feb-2021-Final-v2.pdf> accessed 8 July 2025.
+
+169 NHS Providers, ‘On the Day Briefing - Patient Safety Incidence Response Framework’ (2022) <https://nhsproviders.org/media/694034/on-the-day-briefing-patient-safety-incident-response-framework.pdf> accessed 8 July 2025.
+
+170 NHS England and NHS Improvement, ‘Patient Safety Incident Response Framework 2020: An Introductory Framework for Implementation by Nationally Appointed Early Adopters’ (March 2020) <https://www.england.nhs.uk/wp-content/uploads/2020/08/200312_Introductory_version_of_Patient_Safety_Incident_Response_Framework_FINAL.pdf > accessed 8 July 2025.
+
+171 Defined as ‘unintended or unexpected incidents which could have or did lead to harm for one or more patients receiving healthcare’, ibid 13.
+
+172 HSIB, Learn Together and NHS England, ‘Patient Safety Incident Response Framework Supporting Guidance: Engaging and involving patients, families and staff following a patient safety incident’ (2022) <https://www.england.nhs.uk/wp-content/uploads/2022/08/B1465-2.-Engaging-and-involving…-v1-FINAL.pdf> accessed 8 July 2025.
+
+173 ibid.
+
+174 NHS England, ‘Patient Safety Incident Response Standards’ (2024) <https://www.england.nhs.uk/long-read/patient-safety-incident-response-standards/> accessed 8 July 2025.
+
+175 ibid, para 9.1
+
+176 ibid, para 9.2
+
+177 ibid, para 13.
+
+178 See the sources listed at n 147.
+
+179 MA Bohren and others, ‘Towards a Better Tomorrow: Addressing Intersectional Gender Power Relations to Eradicate Inequities in Maternal Health’ (2024) 67 eClinicalMedicine 102180.
+
+180 NHS England, ‘National Maternity Review’ (n.d.) <https://www.england.nhs.uk/mat-transformation/implementing-better-births/mat-review/> accessed 8 July 2025. See also J Jomeen and M Redshaw, ‘Ethnic Minority Women’s Experience of Maternity Services in England’ (2013) 18 Ethn Health 280 for a similar finding.
+
+181 Department of Health and Social Care (n 13); Department of Health and Social Care, ‘Results of the “Women’s Health – Let’s Talk About It” Survey’ (2022) <https://www.gov.uk/government/calls-for-evidence/womens-health-strategy-call-for-evidence/outcome/results-of-the-womens-health-lets-talk-about-it-survey> accessed 8 August 2025.
+
+182 O’Donovan (n 70).
+
+183 J Reason, ‘Human Error: Models and Management’ (2000) 320 The BMJ 768; NHS Resolution, ‘Being Fair: Supporting a Just and Learning Culture for Staff and Patients following incidents in the NHS’ (2019) <https://resolution.nhs.uk/wp-content/uploads/2019/07/NHS-Resolution-Being-Fair-Report-2.pdf> accessed 8 July 2025.
+
+184 M Brown and others, ‘Exploring the Perceptions Of Senior Medical Students on Gender and Pain: A Qualitative Study of the Interplay between Formal and Hidden Curricula’ BMJ Open 2024; 14:e080420.
+
diff --git a/corpus/healthcare/text/2793085bb0a5d6c1.txt b/corpus/healthcare/text/2793085bb0a5d6c1.txt
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@@ -0,0 +1,872 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11892806
+PMID: 40063591
+DOI: 10.1371/journal.pone.0316646
+Article ID: PONE-D-24-33395
+Article version: 1
+Subjects: Research Article, People and Places, Population Groupings, Professions, Medical Personnel, Pharmacists, Medicine and Health Sciences, Health Care, Health Care Providers, Allied Health Care Professionals, Medicine and Health Sciences, Health Care, Health Care Facilities, People and Places, Geographical Locations, Asia, India, Biology and Life Sciences, Psychology, Psychological Attitudes, Social Sciences, Psychology, Psychological Attitudes, Medicine and Health Sciences, Health Care, Medicine and Health Sciences, Pharmacology, Drug Research and Development, Drug Regulation, Social Sciences, Law and Legal Sciences, Regulations
+
+Developing a competency assessment framework for pharmacists in primary health care settings in India
+
+Developing a competency assessment framework for Primary care pharmacists in India
+
+https://orcid.org/0000-0003-0529-4936 Kumar Sanjeev Conceptualization Data curation Formal analysis Investigation Methodology Project administration Validation Visualization Writing – original draft Writing – review & editing 1 *
+Bhoi Purnima Data curation Project administration Writing – review & editing 2
+Gharat Manjiri Sandeep Data curation Investigation Methodology Writing – review & editing 3 4 5
+Mohanta Guru Prasad Methodology Supervision Writing – review & editing 6
+1 Health Systems Transformation Platform, New Delhi, India
+2 KIIT School of Public Health, Bhubaneswar, India
+3 Prin. K.M. Kundnani Pharmacy Polytechnic, Ulhasnagar, India,
+4 International Pharmaceutical Federation (FIP), The Netherlands,
+5 Community Pharmacy Division-The Indian Pharmaceutical Association (CPA-IPA), Mumbai, India,
+6 Department of Pharmacy, Annamalai University, Chidambaram, India
+Mubarak Naeem Editor
+Lahore Medical and Dental College, PAKISTAN
+* E-mail: snjvkumar386@gmail.comCompeting Interests: Authors with competing interests.
+
+Electronic publication date: 2025 Mar 10
+Publication date: 2025
+Volume: 20
+Issue: 3
+Electronic Location ID: e0316646
+Received 2024 Aug 23; Accepted 2024 Dec 15
+Copyright: © 2025 Kumar et al
+Copyright year: 2025
+Copyright holder: Kumar et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Developing a competency assessment framework for pharmacists in primary health care settings in India. 20 3 10 3 2025 e0316646 e0316646 PLoS One 10.1371/journal.pone.0316646 40063591
+Developing a competency assessment framework for pharmacists in primary health care settings in India. 20 3 10 3 2025 e0316646 e0316646 PLoS One 10.1371/journal.pone.0316646 40063591
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 2
+Table count: 6
+Page count: 16
+Data Availability: All relevant data are within the paper and its Supporting Information files.
+
+Data Availability
+
+All relevant data are within the paper and its Supporting Information files.
+
+Ÿ==============================Ÿ
+Background
+
+Competency frameworks in the pharmacy profession define the necessary practice standards and establish benchmarks for work accountability and career progression. Pharmacists are integral to primary healthcare, and assessing their competencies is essential for improving the performance of primary healthcare services. Although several countries have developed competency frameworks for pharmacists in primary healthcare, such frameworks are currently lacking in India.
+
+Methods
+
+This study aimed to develop a competency assessment framework for in-service pharmacists in Indian public primary healthcare settings. For which, a five-stage consultative process was followed. In the first stage, the systematic literature review was conducted to identify pharmacist competencies in the primary healthcare setting. After that, an expert consultation was organized to develop consensus among experts on competencies and its behaviours. Competency assessment tools were then developed based on the literature and later finalized through experts’ agreements during consultation. Finally, the tools were tested in one of the public primary healthcare facilities.
+
+Results
+
+In stage one, the systematic literature review identified 20 competencies and 175 associated behaviors distributed across four domains: Pharmaceutical Health, Pharmaceutical Care, Organization and Management, and Professional/Personal. Expert consultations resulted in the consensus on 11 roles as domains of pharmacists in Indian primary healthcare settings during stage 2. During the expert consultation, each one of 11 pharmacist’s role and competencies and behaviours was discussed and consensus was arrived on 26 competencies and 107 behaviours. For which, under the role of pharmacy management, one of the critical competency for primary health care pharmacist is the knowledge about the layout and infrastructure of the pharmacy/store and how to adapt it to optimize pharmacy services. For this competency, one of the behaviour is assessment of the existing infrastructure and identifying gaps and opportunities for improvement.
+
+After that in stage 3, a competency assessment tool was developed, and consensus was made on it in stage 4 during expert consultation. The developed tool contains instruments such as a questionnaire to assess knowledge and attitude, and observational checklist, mini-clinical exercises for specific conditions, and simulation exercises to assess skills.
+
+Conclusions
+
+This study successfully developed a competency assessment framework for in-service pharmacists in Indian public primary healthcare settings. The framework encompasses 24 competencies and associated behaviors, covering 11 roles of pharmacists in Indian primary healthcare settings. For example, under the pharmacy management role, some of the competencies include planning and procurement, inventory management, storage conditions, digital literacy to handle supply chain-led IT Systems, NSQ Medical Products Management, etc.
+
+The developed competency assessment tool assessing knowledge, attitude and skills provides a comprehensive framework for assessing pharmacist competencies and identifying competency gaps. The framework can be used to capacitate pharmacists and improve their performance. It improves their performance in primary healthcare settings, and enhance the delivery of healthcare services in India. Additionally, it fills a critical gap in the existing literature and can serve as a valuable resource for policymakers, educators, and healthcare professionals involved in pharmacy practice in primary care settings.
+
+Introduction
+
+Importance of pharmacist competency in primary health care setting
+
+Pharmacists play an important role in primary health care [1]. In primary health care settings, Pharmacists as a team members engage in direct patient care and medication management services (MMS) for ambulatory patients, development of long-term relationships, coordination of care, patient advocacy, wellness and health promotion, triage and referral, and patient education and self-management [2].
+
+Globally, including in low- and middle-income countries (LMICs), the role of pharmacists in primary health care is becoming vital because they support primary health care in meeting the elevated burden of chronic care [1]. The Primary Health Care Performance Initiative (PHCPI) framework has identified providers’ competence as a critical driver to improve PHC performance [3]. In economic terms, an Australian study on the economic impact of increased clinical intervention rates in community pharmacies found that adequately trained and remunerated pharmacists generated savings (on health care, medicines, and pharmacy practice costs) six times greater than those of a control group with no access to the same education or remuneration. It was estimated that adequately trained and remunerated pharmacists would save the health care system 15 million Australian dollars (approx. US$100 million) a year [4]. Similar findings are reported from the USA [5]. Hence, the role of competent pharmacists in PHC performance is crucial.
+
+Pharmacists
+
+The World Health Organization (WHO) defines pharmacists as “healthcare professionals whose professional responsibilities and accountabilities include seeking to ensure that people derive maximum therapeutic benefit from their treatments with medicines” [6]. A pharmacist usually works in one of the three settings, i) Pharmaceutical Industry, ii) Practice Setting, and iii) Others. Other settings include academics, regulators (government), and clinical research. In a practice setting, there are three areas: Community Pharmacy, Hospital Pharmacy, and Clinical Pharmacy [7]. The Community pharmacist is defined as “an individual currently registered and who works according to legal and ethical guidelines to ensure the correct and safe supply of medical products to the public” [8]. While, hospital pharmacists are defined as a “individual currently registered and who works in a hospital pharmacy service, primarily within the public/private sector and responsible for ensuring the safe, appropriate and cost-effective use of medicines” [8]. In India, Primary health care is being delivered through the Primary health centres, where the hospital pharmacists are in place and contributing in maintaining and improve people’s health by advising and information and supplying prescription medicines. Pharmacists are well established in providing primary health care services in facilities. However, their role and contribution to primary health care teams, including roles in community pharmacy practice, are health care reforms in many countries [9].
+
+In the growth of pharmacy practice in India, the health system is encountering multi-pronged challenges, including a shortage of trained teachers, limited skills demonstration facilities for teaching institutions, poor networking among the teaching institutions, limited pharmacist involvement with the community, limited interaction between clinician and pharmacist in patient management [10]. These challenges hinder pharmacists from acquiring competency and further developing competence in pharmacy practice.
+
+Competence & competency, competency assessment framework and competency assessment tool
+
+Competence is one of the critical determinants of improving health outcomes and Client Satisfaction [11]. Provider’s competence is the state of proficiency to perform the required practice activities to the defined standard, which includes the requisite competencies to successfully and effectively deliver high-quality services [11,12]. Providers or individuals develop competence through education, training, and work experience [13]. However, competency is the ability of a person to integrate knowledge, skills, and attitudes in their performance of the tasks in a given context [12]. Competence is dynamic and multidimensional, changing with time, experience, and context/ setting, while competencies are durable, trainable, and measurable through the expression of behaviors. The World Health Organization defines a competency framework “as an organized and structured representation of a set of interrelated and purposeful competencies” [12].
+
+Status of existing pharmacist competency assessment in primary health care settings
+
+In Australia, professional bodies such as the royal pharmaceutical society (RPS) and the Pharmaceutical Society of Australia (PSA) have developed role descriptions and mapped the competencies for General Practice pharmacists [14]. In Canada, the Association of Faculties of Pharmacy (AFPC) educational outcomes for Canadian pharmacists have illustrated the competencies expected of pharmacists in the primary health care setting, either in the community or the primary health care team [9]. Similarly, In the United States of America, the role and competencies of pharmacist working in Primary Care has also been listed [2]. The United Kingdom has also invested in integrating the clinical pharmacist into general practice since 2019, primarily to meet the workforce shortage [15]. Similarly, In the Netherlands, the Clinical Pharmacist has already been part of General practice [16]. Saudi Arabia has identified the competencies of Primary Care pharmacists for adults and paediatrics [17].
+
+Many countries, primarily the global North and a few from the global South have defined the roles and competencies of Pharmacists in Primary Health Care settings [18]. Apart from that, in 2010, The International Pharmaceutical Federation (FIP) also developed the comprehensive Global Competency Framework for the services provided by Pharmacy Workforce, which is widely used globally [13].
+
+Availability of pharmacists in primary health care in India
+
+India National Health Profile, 2022 reports that the total number of registered pharmacists in India until 2021 was 1,334,198. Of these, 24135 pharmacists were employed in public primary health centers [19]. The study conducted in Andhra Pradesh recorded that Primary health centers are experiencing a shortage of 13.3% of pharmacists as per Indian Public health standards [20].
+
+Rationale- why do we need a pharmacist competency assessment framework for India
+
+Healthcare need is increasing because of rising global chronic conditions. This has forced the health system to extend primary Care Services to make them more comprehensive to serve the population need [21]. Understanding the critical role of pharmacists, the UK, Canada, The Netherlands, and other countries have invested in pharmacists to build competencies to improve its performance and meet the primary healthcare needs.
+
+However, in LMICs, it is yet to begin, including India. In India, the situation is further complicated by the double burden of infectious and non-communicable diseases and increasing anti-microbial resistance [22,23]. Due to this, under the comprehensive primary health care package, twelve services have been provisioned in public primary health care institutions. It has significantly increased the pharmacist challenges in delivering health services, which were already facing challenges in competencies due to pre-service education and in-Service training [24].
+
+Identifying the pharmacist’s competency gap is critical for its capacitation in which the Competency Assessment Framework plays a significant role by assessing its competencies. Currently, no pharmacist competency assessment framework exists for Indian settings that can be used to assess competency for in-service pharmacists in primary health care. Hence, developing a competency assessment framework will bridge this gap, which will further help capacitate Primary Health Care Pharmacists.
+
+Study objective
+
+The objective of this study was “to develop the competency assessment framework to assess the In-Service Pharmacist competency in public Primary Health Care setting.” The specific objective was to identify Pharmacists’ competencies and develop Competency Assessment Tools for in-service pharmacists in public primary healthcare settings.
+
+Methods
+
+Study design
+
+We followed a five-stage Fig 1 consultative process to develop the Pharmacist competency assessment framework. The stage-wise details are as below.
+
+10.1371/journal.pone.0316646.g001 Fig 1 Study Stages.
+
+Stage 1 competency identification
+
+In this phase, we did a systematic literature review Fig 2 to identify the Pharmacists’ competencies in the primary health care setting to identify the scientific and grey literature between 2000 to 2020 on PubMed and SSRN. For PubMed, we used the search strategy as; (((“Primary Health Care/education” [Mesh] OR “Primary Health Care/standards”[Mesh])) AND “Pharmacists”[Mesh]) AND (“Professional Competence”[Mesh] OR “Clinical Competence”[Mesh] OR “Cultural Competency”[Mesh] OR “Social Skills”[Mesh]). Two extra filters were used, English and Humans. This strategy retrieved four papers. Similarly, for SSRN, “Pharmacist” as a title was searched, and then “Competence.” This search retrieved only one paper. Google Scholar was also used to retrieve papers using two search strategies; “Primary Care Pharmacist Competency” and “Community Pharmacist Competency.” Through this, 14 and seven papers were retrieved, respectively. Because the competencies have been minimally explored scientifically and are primarily available as guiding documents, Google has been used to search such literature [25]. Through this, 11 papers were retrieved. 38 papers were found from all the sources, of which five were duplicates. The remaining 33 articles were studied in detail, and later, twenty-five articles were removed. Finally, thirteen articles were selected that illustrated at least one domain of Pharmacist Competencies.
+
+10.1371/journal.pone.0316646.g002 Fig 2 PRISMA Selection of Studies.
+
+Stage-2 Expert Consultation: to build consensus on Competencies: In the second stage, we organized expert consultation to build consensus on Competencies and behaviours. This consultation was held virtually on 10th March 2022.
+
+Stage 3 Competency Assessment Tool Development: In this stage, based on the literature, we developed the Instruments to assess the Competencies and their associated behaviors in terms of knowledge, attitude, and skills. These include a questionnaire, observation checklists, mini-clinical exercises and simulation exercises.
+
+Stage 4 Expert Consultation: to build consensus on CAT: In this phase, we organized expert consultation on 14th November 2022 in Bhubaneswar, Odisha, to achieve consensus on Competency Assessment Tool instruments.
+
+Stage-5 Pretesting of Competency Assessment Tool:–After converting the English version of the Competency Assessment Tool into a Bilingual language, i.e., English and Odia (Vernacular Language), we pretested it in One of the public primary health care setting facilities in Odisha, on 13th January 2023.
+
+Experts: During two rounds of expert consultations, twenty experts participated. All the experts were trained Pharmacists and have been involved in delivering Pharmacy services in Primary Health Care Settings or as academia in Pharmacy education or involved in the process of policy making as a multi-lateral organization representative or professional body representative or policy maker with over 20 Years of experience.
+
+During the consultations, we obtained written consent from experts. Since we did not collect data from human participants, this study may be exempt from ethics committee approval.
+
+Results
+
+Stage -1 competencies identification
+
+Through literature, we found 175 behaviours under 20 competencies, distributed among four domains like: Pharmaceutical Health, Pharmaceutical Care, Organization and Management, and Professional/personal. Under the pharmaceutical health domain, health promotion is one of the competencies. There are three behaviours; to assess primary healthcare needs; to advise on health promotion, disease prevention, and control, and a healthy lifestyle; and to provide training programs for community staff and leaders on knowledge and skills for promoting health. Please refer to Table 1 for domains and their associated competencies and refer to S1 File for the detailed list of behaviours.
+
+10.1371/journal.pone.0316646.t001 Table 1 Domains and competencies.
+
+Domains	Competencies	References	
+Pharmaceutical Health	Health Promotion	[13,26–31]	
+Medicine Information and advice	[13,26,28–30,32]	
+Pharmaceutical Care	Assessment of Medicines	[13,27,28,30]	
+Compounding Medicines	[13,26,29,30,32]	
+Dispensing	[13,27,28,30]	
+Medicines	[13,27,32]	
+Monitor Medicines Therapy	[13,27,29,32]	
+Patient Consultation and diagnostics	[13,27,28,30,32]	
+Organisation and Management	Budget and reimbursement	[13,30,33]	
+Human Resource Management	[13,30,32]	
+Service Improvement	[13,26,28,30]	
+Procurement	[13,26]	
+Supply Chain and management	[13,26,28,30]	
+Workplace Management	[13,26–36]	
+Professional/ Personal	Communications Skills	[13,26–31,34–36]	
+Continuing Professional Development	[13,28,30,31,34,35]	
+Legal and Regulatory Practice	[13,26–28,33]	
+Professional and ethical practice	[13,26–29,35]	
+Quality Assurance and Research	[13, 26,28,29,35]	
+Self-Management	[13,26–29,35,36]	
+
+Stage-2 expert consultation
+
+Expert consultation was organized to build consensus among experts on pharmacist competencies and their associated behaviours. However, it emerged during the consultation that role plays a significant role in defining in-service competencies for any cadre of professionals. The consensus was made for eleven roles of Pharmacists in primary health care settings Table 2. After that, competencies and their associated behaviours were discussed, and consensus was achieved.
+
+10.1371/journal.pone.0316646.t002 Table 2 Pharmacist role.
+
+Pharmacist Role in Indian Primary health care setting	
+Pharmacy Management
+
+Dispensing Medical Products
+
+Ensure compliance with regulations on Medical Products
+
+Assistance to Medical Officers in the preparation and implementation of different projects and programs
+
+Outreach to the Community
+
+Professional Practice
+
+Ethical Practice
+
+Communication
+
+Workplace Management
+
+Emergency Role
+
+Continuing Professional Development.
+
+	
+
+Role-1. Pharmacy Management:
+
+In this role, during the consultation, we arrived at the Consensus on nine competencies and fifty-five behaviours, Table 3. In managing a Pharmacy, one of the critical Competencies is Knowledge about the Pharmacy, infrastructure, layout, and how to adapt it to optimize pharmacy services, including inventory management. Equally, knowing the drugs, consumables, and materials to be kept in store, their nature, use, and required storage conditions are important in managing pharmacy. Other competencies for Pharmacists in pharmacy management are maintenance of storage conditions, planning and procurement, inventory management, store verification, condemnation, and maintenance of registers and records. Knowledge about the Not of Standard Quality (NSQ) Medical Products and how to act appropriately is another vital competency for pharmacists in managing pharmacy. In this digital age, it is difficult for pharmacists to avoid the Competency around digital literacy, which helps maintain IT Based Supply chain systems like Drugs and Vaccine Distribution Management System (DVDMS) and e-Niramaya. Considering the limited expertise about medical products at the primary health centre level, Pharmacists should have the Competency to attend different committees’ meetings like Pharmacy (drug) and therapeutic committee, Annual Indent committee, Purchase committee, Condemnation committee, and Prescription audit committee.
+
+10.1371/journal.pone.0316646.t003 Table 3 Pharmacy management competencies.
+
+Knowledgeable about the Pharmacy layout, pharmacy infrastructure, and how to adapt it to optimize pharmacy services, including inventory management.
+
+Knowledgeable about drugs, consumables, and materials to be kept in store, their nature, use, and storage conditions required.
+
+Be able to maintain and ensure the required storage conditions.
+
+Knowledgeable about the procedure for all types of planning and procurement (Pool Procurement)
+
+Able to manage the inventory correctly.
+
+Able to perform and fulfil the duties as a member of different committees in the institution or representing it.
+
+Able to manage drugs and vaccine Distribution Management system (DVDMS)/eNiramaya, and other existing IT systems (Adequate digital literacy)
+
+Able to conduct institutional store verification, condemnation, and maintenance of all registers and records relevant to the Pharmacy and pharmacy store.
+
+Knowledgeable about the information and directions from authorities relating to banned and Not of Standard Quality (NSQ) medicines and acting appropriately
+
+	
+
+Role 2: Dispensing Medical Products:
+
+During the consultation regarding this pharmacist’s role in dispensing medical products, the consensus arrived at five competencies, Table 4, and sixteen behaviours, S2 File. One of the critical competencies is knowledge about drug details for dispensing, including generic/brand names, usage (Indication), dosage (Quantity and frequency), route of administration, how to use, and drug interaction/compatibility. However, Pharmacists also need to monitor the medical products’ use and patient adherence, as appropriate, to ensure positive clinical outcomes. To improve patient adherence to medical products, Pharmacists need to encourage and facilitate. Hence, it is also identified as a competency. Another competency for pharmacists is recognizing the adverse drug reaction and supporting the primary health care team in managing the adverse reaction event.
+
+10.1371/journal.pone.0316646.t004 Table 4 Dispensing medical products competencies.
+
+Knowledgeable about medical products details for dispensing, including generic/brand names, usage (Indication), dosage (Quantity and frequency), route of administration, how to use and drug interaction/compatibility,
+
+Able to monitor medical product use and patient adherence, as appropriate, to ensure positive clinical outcomes.
+
+Encourage and facilitate the patient for medication adherence.
+
+Able to encourage use of medical products.
+
+Able to recognize and support the Primary Health Care team in managing adverse drug reactions
+
+	
+
+Role-3 Ensure compliance with regulations on Medical Products:
+
+Medical products are a highly regulated commodity hence, dealing with them requires compliance with the applied regulations. Towards that, the consensus among the experts made during the consultation is that the Pharmacists in the primary health care setting should be able to guide the primary health care team of the health facility to ensure compliance with laws and regulations as applicable to the medical products, particularly medical products with the narcotics and psychotropic agents. Under this, the consensus was also made on five behaviours S2 File.
+
+Role 4. Assistance to Medical Officer in preparation and implementation of different projects and Programs:
+
+As a Pharmacist in a Primary Health Care setting, one role is to assist Medical Officer in preparing and implementing various health projects and programs, particularly in medical products management and its documentation. For details, please refer S2 File.
+
+Role 5. Outreach to the Community:
+
+In this role, the consensus among the experts was made on two competencies and five behaviours, S2 File. One of them is to assist the primary health care team in organizing community outreach camps. During a disaster, pharmacists’ roles become vital; another competency for Pharmacists is supporting the primary healthcare team in disaster management preparedness.
+
+Role-6 Professional Practice:
+
+During the consultation, the experts unanimously agreed that Pharmacists should necessarily be knowledgeable about roles and responsibilities. Consensus was also reached on one behaviour S2 File.
+
+Role-7 Ethical Practice:
+
+Ethical practice is central to delivering health services. Towards that, the consensus among the experts was made that the Pharmacist should be able to comply with ethical practices as a competency. The agreement was also made on three behaviours S2 File. One of the behaviour is the pharmacists need to be well versed with the of the Pharmacy Council of India Code of Ethics and as given in Pharmacy Practice Regulation.
+
+Role-8 Communication:
+
+The Consensus among the experts during the consultation was that the Pharmacist should be able to communicate effectively in routine and emergencies. The Consensus among the experts was also made on the seven behaviours S2 File.
+
+Role-9 Workplace Management:
+
+Workplace management is one of the typical roles that a pharmacist must play in a Primary Health Care Setting. For that, Consensus arrived during the consultation that one competency which every pharmacist should be able to manage the workplace. There were five behaviours on which the expert agreed. S2 File.
+
+Role-10 Emergency Role:
+
+Under the emergency role, the Consensus among the experts during the consultation was made on three competencies. Pharmacists should essentially have the Competency to perform basic diagnostic tests/ Checks (Diagnostic tests include carrying out Point of Care tests like Blood pressure, Blood Glucose level using Glucometer, Pulse Oximetry, Peak flow tests, Weight, height checks and BMI Calculations, Snellen’s Chart, Pulse, Respiration Rate, Hb using strips, Pregnancy testing, other spot tests using testing kits, etc.), support other health professionals, and handle medical devices/equipment. The government of Odisha, India, has permitted Pharmacists to provide treatment services for minor ailments without doctors [37]. Considering this state government initiative and the need, the experts arrived at the Consensus that pharmacists should also have the competencies to manage minor ailments by recommending medical products for diseases like `Fever, Malaria, Upper Respiratory Tract Infection, Skin diseases (Scabies, Ringworms), Helminthiasis, Acid Peptic Disease (APD), Diarrhoea, Minor Injury without Medico-Legal Cases, Superficial burns without Medico-Legal Cases (MLC), Drainage of abscess, etc. Regarding six behaviours in this role, experts arrived at consensus during the consultation.
+
+Role 11. Continuing Professional Development:
+
+Health Services updates procedures and medical products based on global scientific advancements. Accordingly, the government and other stakeholders keep revising the guidelines. Understanding the volatility of different competencies, experts agreed that the Pharmacist should be willing to participate in Continuing Professional Education/ Development programs to update knowledge and practice. Experts also agreed on two behaviours for the said competency.
+
+Stage -3. Competency assessment tool (CAT) development
+
+In this stage, to assess Pharmacist Competency based on literature, we developed Competency Assessment Tool. We developed the questionnaire to assess the Pharmacist’s knowledge and attitude; under this, 256 questions were constructed, Table 5. The 143 questions were for knowledge, and the rest 113 were for attitude. Further, to assess the Pharmacist’s skills, we used three assessment instruments, Observational Checklists, Mini Clinical Evaluations for Specific Conditions, and Simulation exercises [12,38]. Under Observation, we identified twenty-four skills; under mini-clinical evaluation exercises, we identified thirty skills and four skills under simulation exercises. For the Observation and Mini Clinical Evaluation of selected conditions, we identified the tracer elements for the skills and listed them as means of verification. To standardize the score based on means of verification, we developed the standard score definitions, Table 6 for observations and mini-clinical evaluation of selected conditions.
+
+10.1371/journal.pone.0316646.t005 Table 5 Competency assessment tool-instrument details.
+
+Competency Elements	Instruments	Number of Questions/ Skills	
+Pre-Consultation	Post Consultation	
+Knowledge	Questionnaire	143	48	
+Attitude	Questionnaire	113	48	
+Skills	Observational Checklist	24	20	
+Mini Clinical Exercises for Specific Conditions	30	30	
+Simulation Exercises	4	4	
+
+10.1371/journal.pone.0316646.t006 Table 6 Score definition.
+
+Score Definition
+
+A None—No demonstrated skills at all/does not perform the task(s) completely.
+
+B Limited Demonstrated very limited strengths/skills in this area.
+
+C Some—Demonstrated some ability/skills in this area.
+
+D Strong—Demonstrated strong skills/strength in this area.
+
+E Excellent—Demonstrated excellent skills/strength in this area.
+
+F Not applicable
+
+G Don’t know- not even heard about that skill.
+
+H Skill limitation is related to resource limitations
+
+	
+
+Stage-4 expert consultation
+
+In this stage, to develop the consensus among the experts on the Competency Assessment Tool, we organized an expert consultation on Nov 14, 2022, in Bhubaneswar. Consensus arrived on the Ninety-Six Questions during this consultation to assess knowledge and attitude. Out of ninety-six, forty-eight were for knowledge, while the rest were for attitude. On Observational skills, Consensus arrived at 20 skills, while it was thirty for Mini Clinical evaluation for specific conditions. For Simulation exercises, experts were in a consensus for all four skills, Table 5.
+
+Stage-5 CAT pre-testing
+
+In this stage, the English version of CAT was converted into the bilingual format in English and Odia, S3 File. After that, we pre-tested in one of the public primary health care settings facilities in Khorda district, Odisha, India. We found that technical words like inventory management, not of Standard Quality, Supply Chain, prescription error, and prescription validation were comparatively more understandable in English than in Odia. We also understood that in place of the Drugs and Vaccines Distribution Management System (DVDMS), E-Niramaya, an IT-based supply chain system, is being used at the facility level. Accommodating these learnings, we developed the final version of bilingual CAT.
+
+Discussion
+
+We developed the competency assessment framework for In-Service pharmacists in primary healthcare settings. Under this, we identified the role-based competencies and their associated behaviours. Along with the competencies and their related behaviours, we developed the assessment tool to determine the degree of competency among in-Service pharmacists. In this way, this assessment framework will be helpful for policymakers and implementers in designing, monitoring, and evaluating pharmacist competencies. It will further improve pharmacist performance in the primary healthcare facilities.
+
+Factors Influencing Pharmacist Competency: One of the factors that influence pharmacist competency the most is pre-service education. Teaching institutions engaged in pharmacist production face challenges in ensuring the availability of trained teachers. Qualified teachers who have exposure to be in the practice domain are very limited. Acquiring skills is not possible unless the teaching institutions have skills demonstration facilities. The shortage of skill demonstration facilities is also becoming a hindrance to developing skills during pre-service education and further prevents Pharmacists from entering pharmacy practice [10]. Another challenge of Pre-service education is the outdated curriculum and education regulations [39].
+
+The National Education Policy 2020 emphasizes the importance of skill-based training in pharmacy education. Therefore, it is essential for the Pharmacy Council of India, the apex body responsible for regulating education and the profession in India, to update the pharmacy curriculum based on current health industry requirements [40]. In 2020, the curriculum for the diploma in pharmacy was revised for the first time in three decades. To prevent such lengthy delays in the future, the Pharmacy Council of India should establish a mechanism for periodically reviewing and updating curricula to align with industry and health sector needs.
+
+The University Grants Commission (UGC) of the Government of India is tasked with ensuring quality in higher education, including pharmacy programs. One of its key responsibilities of UGC is to maintain teaching standards in higher education [41]. To address the impending shortage of skilled pharmacy educators, the UGC could design programs focused on enhancing the teaching competencies of pharmacy instructors. This initiative would undoubtedly help improve the overall quality of pharmacy education.
+
+For the public health system, the Union and State governments have attempted to capacitate in-service Pharmacists except under the Revised National Tuberculosis Training Program [42]. Some States have made specific efforts to capacitate pharmacists, but even those efforts were limited to Store Management and Rational use of Drugs [43].
+
+Importance of competency assessment framework in developing competency-based training for pharmacists
+
+The Competency assessment framework is the foundation for designing competency-based training (CBT) program for pharmacists, which helps them in improving their performance, irrespective of the settings [44]. The framework provides structured tool to assess the competencies in terms of knowledge, attitude, and skills and helps to understand the role in which the pharmacist is experiencing competency gaps with specific knowledge, attitude, and skills. The framework also helps design competency-based training manuals and develop a pool of trainers to capacitate and bridge the competency gaps.
+
+In India, there are lacunae in the design of the training program for capacitating in-service pharmacist [45]. Competency-based training (CBT), a structured training and assessment system that allows individuals to acquire skills and knowledge to perform work activities to a specified standard, is a globally accepted solution to capacitate the in-service professional [46]. For which the developed Competency assessment framework, based on the role-based competencies and their behaviour, along with the competency assessment tool, will play a foundational role in developing the Competency-based training manual and other resource materials for Pharmacists in primary health Care Settings.
+
+Strengths and limitations
+
+The strength of this study is the consultative approach through which the Competency assessment framework has been developed. In this process, twenty experts in community pharmacy took part. These experts have over 20 Years of experience in teaching, policymaking, and practice from Teaching Institutions, Union and State Governments, professional bodies, Private retail pharmacy, and Public Primary Health Care facilities. In both consultations, twenty experts participated; hence, we recognize that the experts who participated in this study cannot be considered the complete representation of all the stakeholders for the In-Service Pharmacist Competency development initiative.
+
+In method, In the first stage to identify literature-based competencies, we searched the literature from 2000 to 2020. We likely missed some of the relevant old and recent pieces of literature. Attitude assessment of a professional is a complex process; however, we developed the questionnaire to assess Pharmacists’ attitudes. It is possible that the questionnaire to assess attitude cannot capture the responses entirely and accurately.
+
+Apart from that, we did not use any tool to check the validity of the score definition for Skills assessment (Observation and Mini Clinical Exercises). We also understand that we pre-tested CAT in only one public facility in Odisha, India, and did not use any quantitative tool to check its validity.
+
+The developed competency assessment framework is comprehensive. Hence, administering CAT to assess in-service pharmacist competency is time-consuming. As professionals’ role evolves over time based on service requirements, this competency assessment framework will need periodic review and updating.
+
+For the first time, this study has developed role-based competencies and competency assessment tools for in-service pharmacists in the Indian context; hence, if any new addition happens with the Pharmacist role, based on the extended role, the competencies, and their associated behaviours must be included accordingly.
+
+Conclusion
+
+This study has developed a competency assessment framework for in-service primary healthcare pharmacists. It includes a set of competencies and a competency assessment tool designed to evaluate these competencies. The competencies and associated behaviors have been defined based on the roles of in-service pharmacists. The competency assessment tool evaluates pharmacists’ knowledge, attitudes, and skills to assess their competencies.
+
+The competency assessment framework will help identify the training needs of in-service pharmacists in primary healthcare settings. It will also assist the primary healthcare system in designing competency-based training programs. This type of training is expected to enhance pharmacists’ competencies, ultimately improving the quality of services provided in primary healthcare facilities.
+
+Practice Implication: Using this Competency Assessment framework, the health system implementers can identify the gap in serving Pharmacists’ competencies in primary health care settings. Further, it can be instrumental in developing and designing competency-based training to upskill them.
+
+Supporting information
+
+S1 File This is the S1 File literature based competencies and its behaviour List.
+
+(PDF)
+
+S2 File This is the S1 File pharmacists role based competencies and behaviours List.
+
+(PDF)
+
+S3 File This is the S1 File competency assessment tool.
+
+(PDF)
+
+We would like to thank Mr. Rajeev Sadanandan, Dr. N. Devadasan, Mr. Sunil Nandraj, Dr. Kumaravel Ilangovan, Ms. Pallavi Gupta from HSTP for their useful suggestions on development of this paper. We also recognize the contributions of the experts who participated in the study consultations.
+
+Abbreviations
+
+LMIC Low- and middle-Income Countries
+
+PHC Primary health care
+
+WHO World Health Organization
+
+PSA Pharmaceutical Society of Australia
+
+AFPC Association of Faculties of Pharmacy
+
+CAT Competency Assessment Tool
+
+CBT Competency-based Training
+
+FIP International Pharmaceutical Federation
+
+NSQ Not of Standard Quality
+
+HSTP Health Systems Transformation Platform
+
+CPD-IPA Community Pharmacy Division, Indian Pharmaceutical Association
+
+DOI: 10.1371/journal.pone.0316646.r001
+
+Author response to Decision Letter 0
+
+Submission Version: 0
+
+23 Aug 2024
+
+DOI: 10.1371/journal.pone.0316646.r002
+
+Decision Letter 0
+
+Mubarak Naeem Academic Editor
+Copyright: © 2025 Naeem Mubarak
+Copyright year: 2025
+Copyright holder: Naeem Mubarak
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 0
+
+22 Oct 2024
+
+PONE-D-24-33395Developing a competency assessment framework for pharmacists in primary health care settings in IndiaPLOS ONE
+
+Dear Dr. Kumar,
+
+Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
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+Naeem Mubarak, PhD
+
+Academic Editor
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+PLOS ONE
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+Reviewer #1: Yes
+
+**********
+
+2. Has the statistical analysis been performed appropriately and rigorously?
+
+Reviewer #1: No
+
+**********
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+
+The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.
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+5. Review Comments to the Author
+
+Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
+
+Reviewer #1: Thank you, managing editorial, for giving me this opportunity to review the article “Developing a competency assessment framework for pharmacists in primary health care settings in India” in this prestigious journal. This article provides the initial primary stages and roles for developing the competency assessment framework for primary health care in India.
+
+Abstract
+
+In the background, it's crucial to highlight the significance of the competency framework for pharmacists, as it underpins their professional development and performance.
+
+The method of assessment was insufficiently described.
+
+To whom were the competency framework and associated behaviour discussed and agreed upon? Please clarify the statement.
+
+In general, there is a lack of information about the competencies, just the number of competencies and the number of roles. Kindly add some lines in the result or conclusion about which competency framework for pharmacists has been introduced.
+
+Introduction
+
+Please add an example from the primary rather than the community set-up to elaborate on the importance of competency at the primary healthcare level.
+
+Add a few lines about the availability of pharmacists at the primary healthcare level and then explain their importance to their country's prospects.
+
+The authors are advised to specify the status of pharmacists at their country level because these studies are of Indian origin. So, the targeted approach will be more important than covering the whole world.
+
+Please advise the authors to reference the statements, as no competency assessment has already been conducted in their country.
+
+There is no introduction regarding the competency tool and globally available competencies for pharmacists at the primary level.
+
+Method
+
+Authors are advised to use the assessment tool for literature review for effective data collection and representation.
+
+In stage two, on which basis the experts were selected for consultation.
+
+In stage three, which instrument was used for assessing competencies? Please specify.
+
+There should be numbered score definitions in the assessment tool.
+
+Is there only English grammar pretesting required for the competency assessment tool?
+
+Results
+
+The competencies selected in the literature review are related to the in-service pharmacist or not. These competencies were related to pharmacists or taken as general.
+
+On which basis were the eleven roles made for pharmacist competencies, and on which bases were they selected?
+
+In role 2, how is it possible for a pharmacist to observe the optimal use of medical products?
+
+In role 3, please specify which drugs require high compliance with regulations.
+
+In role 4, although medical product management and documentation are solely the responsibility of the pharmacist as they are available in the pharmacy, the pharmacist assists the medical officer with these tasks.
+
+In role 7, on which limit the ethical practice will be allowed. Please specified.
+
+In role 10, Is it possible for the author to please specify the list of diagnostic tests and checks in emergencies?
+
+In role 11, authors are advised to please specify the programs for continuing professional development in Indian origin.
+
+Authors are advised to reduce the paragraph content as already described in the table.
+
+Authors are advised to provide the details of the validation of the competency assessment tool.
+
+Which tests were performed during the pre-testing of the competency assessment tool?
+
+Discussion
+
+The discussion regarding the factors related to coping with pre-service education is limited. The authors advised adding more possible measures to cope with these challenges at the government level.
+
+The discussion regarding the importance and implications of competence assessment was very limited, making this portion weak.
+
+**********
+
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+
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+
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+
+Reviewer #1: No
+
+**********
+
+[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]
+
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+
+DOI: 10.1371/journal.pone.0316646.r003
+
+Author response to Decision Letter 0
+
+Submission Version: 1
+
+6 Nov 2024
+
+Sr. No. Section Comments Response Description-Response (Page and Line Number
+
+1. Abstract In the background, it's crucial to highlight the significance of the competency framework for pharmacists, as it underpins their professional development and performance. Referring to the suggestion, I made the required changes. Please refer to ln No. 35 to 40 on page 2
+
+2 The method of assessment was insufficiently described. Referring to the suggestion, I made the required changes. Please refer to ln No. 42 to 49 on page 2
+
+3 To whom were the competency framework and associated behaviour discussed and agreed upon? Please clarify the statement. Referring to the suggestion, I made the required changes. Please refer to ln No. 53 to 54 on page 2
+
+4 In general, there is a lack of information about the competencies, just the number of competencies and the number of roles. Kindly add some lines in the result or conclusion about which competency framework for pharmacists has been introduced. Referring to the suggestion, I made the required changes. Please refer to ln No. 88 to 101 on page 3.
+
+5 Introduction Please add an example from the primary rather than the community set-up to elaborate on the importance of competency at the primary healthcare level. I tried my best to include articles from primary healthcare settings.
+
+6 Add a few lines about the availability of pharmacists at the primary healthcare level and then explain their importance to their country's prospects. Referring the suggestion, made the necessary changes. Please refer to ln No. 198 to 202 on page 6.
+
+7 The authors are advised to specify the status of pharmacists at their country level because these studies are of Indian origin. So, the targeted approach will be more important than covering the whole world. Yes, I tried my best to share status in an Indian setting Please refer to ln No. 211 to 217 on page 6.
+
+8 Please advise the authors to reference the statements, as no competency assessment has already been conducted in their country We learned from literature search and expert consultation that there is no competency assessment framework.
+
+9 There is no introduction regarding the competency tool and globally available competencies for pharmacists at the primary level. We discussed about the FIP competency framework and later in stage 1, we listed the competencies under different domains from various studies. Please refer to ln No. 179 to 197 on pages 5 and 6.
+
+10 Method Authors are advised to use the assessment tool for literature review for effective data collection and representation. In stage 1, we used a systematic approach to searching literature through a defined search strategy and followed PRISMA guidelines. Please refer to Fig 1 for details.
+
+11 In stage two, on which basis the experts were selected for consultation? We identified experts based on selection criteria such as education, years of experience, and current role. Please refer to the experts section. Please refer to ln No. 277 to 281 on page 8.
+
+12 In stage three, which instrument was used for assessing competencies? Please specify. Referring to the suggestion, we made the changes. Please refer to ln No. 268 to 269 on page 8.
+
+13 There should be numbered score definitions in the assessment tool. We developed the score definition for the instruments assessing skills as Observational checklists and mini-clinical exercises. Please refer to table 8 Score definition. Please refer to table 5 on page 14
+
+14 Is there only English grammar pretesting required for the competency assessment tool? No, we pre-tested the competency assessment tool in bilingual format in English and Odia. Please refer to ln no 466 and 467.
+
+15 Results The competencies selected in the literature review are related to the in-service pharmacist or not. These competencies were related to pharmacists or taken as general. Yes, the literature review is related to the pharmacists working in primary health care settings.
+
+16 On which basis were the eleven roles made for pharmacist competencies, and on which bases were they selected? In stage 2, during the consultation, it emerged that rather than considering the domain, it is better to use the role as a basis to define competencies. These roles are primarily based on the Indian Public Health Standard, 2022, and later on, the consensus among experts, 11 roles were finalized. Please refer to ln no 318-320 on page 9.
+
+17 In role 2, how is it possible for a pharmacist to observe the optimal use of medical products? In role 2, one of the competencies is- Able to encourage the use of medical products.
+
+The pharmacist can encourage patients to return unused, unwanted, or expired medicines to the Pharmacy for safe disposal. Pharmacists can also maintain records of returned medical products to monitor usage further.
+
+The additional file mentions these two ways as behaviors for the said competencies. For details, please refer to Additional file 2. Please refer to additional file 2.
+
+18 In role 3, please specify which drugs require high compliance with regulations. Medical products with narcotics and psychotropic agents require high compliance with regulations.
+
+We made the suggested changes. Please refer to ln no 362-363 on page 12.
+
+19 In role 4, although medical product management and documentation are solely the responsibility of the pharmacist as they are available in the pharmacy, the pharmacist assists the medical officer with these tasks. Primary health Centres conduct various activities for public health programs, including Leprosy, Tuberculosis, and Vector disease control programs. In those cases, the Pharmacist is supposed to assist the medical officer with medical product management and documentation.
+
+20 In role 7, on which limit the ethical practice will be allowed. Please specified. Regarding ethical practice, the consensus made among the experts as one of the behaviors is -
+
+“Be well versed with the Code of Ethics of the Pharmacy Council of India and as given in Pharmacy Practice Regulation.” (Please refer to additional file 2 )
+
+Made the required changes in the manuscript. Please refer to additional file 2.
+
+21 In role 10, Is it possible for the author to please specify the list of diagnostic tests and checks in emergencies? We specified the list of diagnostics in the manuscript. These tests are described as behaviors in Additional File 2. Please refer to additional file 2
+
+22 In role 11, authors are advised to please specify the programs for continuing professional development in Indian origin. In India, there is no structured program for pharmacists' continuing professional development. The National Health Mission, along with other initiatives, organizes capacity-building programs regularly. In light of this, one behavior that emerged from expert consensus is actively participating in the various training programs offered by the National Health Mission and other health programs established by the Ministry of Health and Family Welfare (MoHFW) and State Health Departments.
+
+For details, please refer to additional file 2. Please refer to additional file 2.
+
+23 Authors are advised to reduce the paragraph content as already described in the table. We removed two tables-table 4 and 5.
+
+24 Authors are advised to provide the details of the validation of the competency assessment tool. Which tests were performed during the pre-testing of the competency assessment tool? We developed the CAT using a content validation (Stage 4) approach. Later, under stage 5, we pre-tested the CAT in one of the public health facilities to understand the construct regarding language clarity and local programmatic variations. Please refer to ln no 467 to 475 on pages 15 and 16.
+
+25 Discussion The discussion regarding the factors related to coping with pre-service education is limited. The authors advised adding more possible measures to cope with these challenges at the government level. We made the needful changes. Please refer to ln no 493 to 515 on pages 16 and 17.
+
+26 The discussion regarding the importance and implications of competence assessment was very limited, making this portion weak. We made the needful changes. Please refer to ln no 522 to 536 on page 17.
+
+Attachment Submitted filename: Response to Reviewers.docx
+
+DOI: 10.1371/journal.pone.0316646.r004
+
+Decision Letter 1
+
+Mubarak Naeem Academic Editor
+Copyright: © 2025 Naeem Mubarak
+Copyright year: 2025
+Copyright holder: Naeem Mubarak
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 1
+
+16 Dec 2024
+
+Developing a competency assessment framework for pharmacists in primary health care settings in India
+
+PONE-D-24-33395R1
+
+Dear Dr. Sanjeev Kumar,
+
+We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.
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+
+Kind regards,
+
+Naeem Mubarak, PhD
+
+Academic Editor
+
+PLOS ONE
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+
+Reviewer #2: All comments have been addressed
+
+**********
+
+2. Is the manuscript technically sound, and do the data support the conclusions?
+
+The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.
+
+Reviewer #2: Yes
+
+**********
+
+3. Has the statistical analysis been performed appropriately and rigorously?
+
+Reviewer #2: Yes
+
+**********
+
+4. Have the authors made all data underlying the findings in their manuscript fully available?
+
+The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.
+
+Reviewer #2: Yes
+
+**********
+
+5. Is the manuscript presented in an intelligible fashion and written in standard English?
+
+PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.
+
+Reviewer #2: Yes
+
+**********
+
+6. Review Comments to the Author
+
+Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
+
+Reviewer #2: The author has thoroughly addressed all the comments and suggestions. After reviewing the updated manuscript, I find the revisions satisfactory and in line with the objectives of the work. At this stage, I have no further suggestions or comments to add.
+
+**********
+
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+
+Reviewer #2: No
+
+**********
+
+DOI: 10.1371/journal.pone.0316646.r005
+
+Acceptance letter
+
+Mubarak Naeem Academic Editor
+Copyright: © 2025 Naeem Mubarak
+Copyright year: 2025
+Copyright holder: Naeem Mubarak
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
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+PONE-D-24-33395R1
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+PLOS ONE
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+References
+
+1 Tsuyuki RT , Beahm NP , Okada H , Al Hamarneh YN . Pharmacists as accessible primary health care providers: Review of the evidence. Can Pharm J (Ott). 2018;151(1):4–5. doi: 10.1177/1715163517745517 29317929 PMC5755826
+2 Dodd MA , Haines SL , Maack B , Rosselli JL , Sandusky JC , Scott MA , et al. ASHP statement on the role of pharmacists in primary care. Am J Health Syst Pharm. 2022;79(22):2070–8. doi: 10.1093/ajhp/zxac227 36099084
+3 Initiative PHCP. The PHCPI Conceptual Framework | PHCPI [Internet]. 2021 [cited 2021 Oct 1]. Available from: https://improvingphc.org/phcpi-conceptual-framework
+4 Benrimoj SI , Langford JH , Berry G , Collins D , Lauchlan R , Stewart K , et al. Economic impact of increased clinical intervention rates in community pharmacy. A randomised trial of the effect of education and a professional allowance. Pharmacoeconomics. 2000;18(5):459–68. doi: 10.2165/00019053-200018050-00005 11151399
+5 Schumock GT , Butler MG , Meek PD , Vermeulen LC , Arondekar BV , Bauman JL , et al. Evidence of the economic benefit of clinical pharmacy services: 1996-2000. Pharmacotherapy. 2003;23(1):113–32. doi: 10.1592/phco.23.1.113.31910 12523470
+6 World Health Organization. Joint FIP/WHO guidelines on good pharmacy practice: standards for quality of pharmacy services. WHO Technical Report Series, No. 961. 2011;(961):Annex 8, 14 pages.
+7 A Career in Pharmacy [Internet]. Pharmacy Council of India and Indian Pharmaceutical Association. 2009. Available from: https://www.pci.nic.in/Circulars/career.pdf
+8 India TG of. Pharmacy Practice Regulations, 2015 [Internet]. 33004/99 India; 2015. Available from: https://www.pci.nic.in/pdf/PharmacyPracticeRegulations.pdf
+9 Kennie-Kaulbach N , Farrell B , Ward N , Johnston S , Gubbels A , Eguale T , et al. Pharmacist provision of primary health care: a modified Delphi validation of pharmacists’ competencies. BMC Fam Pract. 2012;13:27. doi: 10.1186/1471-2296-13-27 22455482 PMC3372430
+10 Tiwari P . The six challenges to pharmacy practice in India. Rev Artic CRIPS [Internet]. 2022 [cited 2023 Mar 28];16(1). Available from: https://www.accp.com/docs/positions/commentaries/
+11 Kak N , Burkhalter B , Cooper M-A . Measuring the Competence of Healthcare Providers. Operations Research Issue Paper 2(1). Bethesda, MD: Published for the U.S. Agency for International Development (USAID) by the Quality Assurance (QA) Project [Internet]. 2001. Available from: https://pdf.usaid.gov/pdf_docs/pnacm829.pdf
+12 Organization WH. Global Competency and Outcomes Framework for Universal Health Coverage [Internet]. 2022. Available from: https://www.who.int/publications/i/item/9789240034662
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+14 General Practice Pharmacist | Pharmaceutical Society of Australia [Internet]. n.d. [cited 2021 Oct 3]. Available from: https://www.psa.org.au/career-and-support/career-pathways/general-practice-pharmacist/
+15 Mueller T , Preston KE , Mcfadyen Weir N , Bennie M , Newham R . Competencies required for General Practice Clinical Pharmacists providing the Scottish Pharmacotherapy Service: A modified eDelphi study. Health Soc Care Community. 2021;29(6):e328–37. doi: 10.1111/hsc.13357 33756042
+16 Hazen A , Sloeserwij V , Pouls B , Leendertse A , de Gier H , Bouvy M , et al. Clinical pharmacists in Dutch general practice: an integrated care model to provide optimal pharmaceutical care. Int J Clin Pharm. 2021;43(5):1155–62. doi: 10.1007/s11096-021-01304-4 34216352 PMC8460522
+17 Ahmed Alomi Y , Pharm Scien Jp . National Primary Care Pharmacist Competency System at MOH in Saudi Arabia. JPharm Pharm Scien [Internet]. 2016 [cited 2021 Oct 3];1(4):1–5. Available from: www.verizonaonlinepublishing.com
+18 Benson H , Lucas C , Benrimoj SI , Williams KA . The development of a role description and competency map for pharmacists in an interprofessional care setting. Int J Clin Pharm. 2019;41(2):391–407. doi: 10.1007/s11096-019-00808-4 30879217
+19 Central Bureu of Health Intelligence. National Health Profile [Internet]. New Delhi, India: Ministry of Health & Family Welfare, Government of India f; 2022. Available from: https://cbhidghs.mohfw.gov.in/WriteReadData/l892s/94203846761680514146.pdf
+20 Sriram S . Availability of infrastructure and manpower for primary health centers in a district in Andhra Pradesh, India. J Family Med Prim Care. 2018;7(6):1256–62. doi: 10.4103/jfmpc.jfmpc_194_18 30613507 PMC6293956
+21 WHO. Primary health care [Internet]. n.d. [cited 2021 Oct 3]. Available from: https://www.who.int/news-room/fact-sheets/detail/primary-health-care
+22 Research, Indian Council of Medical Research G of I. Annual Report- Antimicrobial Resistance Research and Surveillance Network [Internet]. 2020 [cited 2023 Mar 16]. Available from: https://main.icmr.nic.in/sites/default/files/guidelines/AMRSN_annual_report_2020.pdf
+23 ICMR, PFHI, IHME. India: Health of the Nation’s States Burden. Minist Heal Fam Welfare, Gov India [Internet]. 2017;211. Available from: https://www.healthdata.org/sites/default/files/files/policy_report/2017/India_Health_of_the_Nation%27s_States_Report_2017.pdf
+24 Meghana A , Aparna Y , Chandra SM , Sanjeev S . Emergency preparedness and response (EP&R) by pharmacy professionals in India: Lessons from the COVID-19 pandemic and the way forward. Res Social Adm Pharm. 2021;17(1):2018–22. doi: 10.1016/j.sapharm.2020.04.028 32362583 PMC7194881
+25 Piasecki J , Waligora M , Dranseika V . Google search as an additional source in systematic reviews. Sci Eng Ethics. 2018;24(2):809–10.10.1007/s11948-017-0010-4 PMC5876410 29249022
+26 Suwannaprom P , Suttajit S , Eakanunkul S , Supapaan T , Kessomboon N , Udomaksorn K , et al. Development of pharmacy competency framework for the changing demands of Thailand’s pharmaceutical and health services. Pharm Pract (Granada). 2020;18(4):2141. doi: 10.18549/PharmPract.2020.4.2141 33343773 PMC7732214
+27 Competencies for Canadian Pharmacists at Entry to Practice [Internet]. Authorities, National Association of Pharmacy Regulatory, Canada. 2014. Available from: https://napra.ca/sites/default/files/2017-08/Comp_for_Cdn_PHARMACISTS_at_EntrytoPractice_March2014_b.pdf
+28 The Pharmaceutical Society of Ireland. Competency Framework Ireland. 2013;20. Available from: https://www.psi.ie/sites/default/files/2024-06/PSI_Core_Competency_Framework.pdf
+29 Australia TPS of. National Competency Standards Framework for Pharmacists in Australia [Internet]. Technical Report. 2016. 1–92 p. Available from: https://www.psa.org.au/download/standards/competency-standards-complete.pdf
+30 Sacre H , Hallit S , Hajj A , Zeenny RM , Akel M , Raad E , et al. developing core competencies for pharmacy graduates: the lebanese experience. J Pharm Pract. 2022;35(2):332–9. doi: 10.1177/0897190020966195 33084476
+31 Arakawa N , Yamamura S , Duggan C , Bates I . The development of a foundation-level pharmacy competency framework: An analysis of country-level applicability of the Global Competency Framework. Res Social Adm Pharm. 2020;16(3):396–404. doi: 10.1016/j.sapharm.2019.06.007 31324568
+32 Ministry of Health S. Development Framework -Continuam of Competency for Pharmacists [Internet]. 2020. Available from: https://www.moh.gov.sg/docs/librariesprovider4/default-document-library/(fa)development_framework_for_pharmacists_2020_v1-13e1a9c4bbed944fbb515cd8e5fc28820.pdf
+33 Bradley H , Lehmann U , Butler N . Emerging roles and competencies of district and sub-district pharmacists: a case study from Cape Town. Hum Resour Health. 2015;13:88. doi: 10.1186/s12960-015-0081-8 26601807 PMC4658810
+34 Meadows N , Webb D , McRobbie D , Antoniou S , Bates I , Davies G . Developing and validating a competency framework for advanced pharmacy practice. Pharmaceutical J. 2004;273(1):789–92. doi: 10.1234/pj.2004.789
+35 Schalekamp T. Haisma HJ . Pharmacist Competency Framework & Domain-specific Frame of Reference for the Netherlands [Internet]. 2016 [cited 2021 Sep 6]. Available from: https://www.knmp.nl/media/197#:~:text=Thecompetencyframeworkwasdeveloped,andtherelevantlegalframeworks
+36 Koehler TC , Bok H , Westerman M , Jaarsma D . Developing a competency framework for pharmacy technicians: Perspectives from the field. Res Social Adm Pharm. 2019;15(5):514–20. doi: 10.1016/j.sapharm.2018.06.017 29983262
+37 Health & Family Welfare Department the G of O. Office Order-Minor Ailments And Drugs Dispensed by Pharmacist. 2021. p. 3.
+38 World Health Organization. WHO Simulation Exercise Manual [Internet]. 2017. Available from: https://apps.who.int/iris/bitstream/handle/10665/254741/WHO-WHE-CPI-2017.10-eng.pdf?sequence=1&isAllowed=y
+39 Jishnu V , Gilhotra RM , Mishra DN . Pharmacy education in India: strategies for a better future. J Young Pharm. 2011;3(4):334.22224042 10.4103/0975-1483.90248 PMC3249748
+40 Organization IL. Competency-Based Training (CBT): An Introductory Manual for Practitioners [Internet]. 2020 [cited 2023 Mar 28]. Available from: www.ilo.org/publns
+41 Roegiers X . A Conceptual Framework for Competencies Assessment | International Bureau of Education. Unesco [Internet]. 2016;(4):44. Available from: http://www.ibe.unesco.org/en/document/conceptual-framework-competencies-assessment
+42 Somani R . Implementation of National Education Policy 2020 in Pharmacy Education. Ind J Pharm Edu Res. 2024;58(2s):s354–8. doi: 10.5530/ijper.58.2s.38
+43 Univserity Grants Commission [Internet]. 2024 [cited 2024 Nov 6]. University Grants Commission, Government of India. Available from: https://www.ugc.gov.in/Aboutus/Mandate
+44 State Institute of Health & Family Welfare, Rajasthan I. Drug Store Management and Rational Drug Use Reading Material on Drug Store Management & Rational Drug Use For Medical Officers, Nurses & Pharmacists [Internet]. 2010 [cited 2023 Mar 28]. Available from: http://sihfwrajasthan.com/Studies/DrugMgmt.pdf
+45 Central TB Division, Ministry of Health and Family Welgare Government of India and IPA. Training Module For Community Pharmacists [Internet]. 2013 [cited 2023 Mar 28]. Available from: www.ipapharma.org
+46 Basak SC , Sathyanarayana D . Community pharmacy practice in India: past, present and future. South Med Rev. 2009;2(1):11–4. 23093872 PMC3471162
diff --git a/corpus/healthcare/text/27ab65640bf99e85.txt b/corpus/healthcare/text/27ab65640bf99e85.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: NPJ Digit Med
+Journal ID: NPJ Digit Med
+NLM Journal ID: 101731738
+
+NPJ Digital Medicine
+
+EISSN: 2398-6352
+Publisher: Nature Publishing Group
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12594812
+PMID: 41203889
+DOI: 10.1038/s41746-025-02098-9
+Article ID: 2098
+Article version: 1
+Subjects: Author Correction
+
+Author Correction: Integrating digital gait data with metabolomics and clinical data to predict outcomes in Parkinson’s disease
+
+http://orcid.org/0000-0001-6802-4242 Brzenczek Cyril 1
+Klopfenstein Quentin 1
+http://orcid.org/0000-0002-4254-2399 Hähnel Tom 2 3
+Sapienza Stefano 4 5
+Klucken Jochen On behalf of the NCER-PD Consortium 4 5 6
+http://orcid.org/0000-0002-5328-1243 Fröhlich Holger 2 7
+http://orcid.org/0000-0003-3977-7469 Glaab Enrico enrico.glaab@uni.lu
+1
+1 https://ror.org/036x5ad56 grid.16008.3f 0000 0001 2295 9843 Biomedical Data Science Group, Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg, Esch-sur-Alzette, Luxembourg
+2 https://ror.org/00trw9c49 grid.418688.b 0000 0004 0494 1561 Department of Bioinformatics, Fraunhofer Institute for Algorithms and Scientific Computing, Sankt Augustin, Germany
+3 https://ror.org/042aqky30 grid.4488.0 0000 0001 2111 7257 Department of Neurology, Medical Faculty and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
+4 https://ror.org/036x5ad56 grid.16008.3f 0000 0001 2295 9843 Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
+5 https://ror.org/012m8gv78 grid.451012.3 0000 0004 0621 531X Luxembourg Institute of Health, Strassen, Luxembourg
+6 https://ror.org/03xq7w797 grid.418041.8 0000 0004 0578 0421 Centre Hospitalier de Luxembourg, Strassen, Luxembourg
+7 https://ror.org/041nas322 grid.10388.32 0000 0001 2240 3300 Bonn-Aachen International Center for IT (b-it), University of Bonn, Bonn, Germany
+8 https://ror.org/03xq7w797 grid.418041.8 0000 0004 0578 0421 Centre Hospitalier Emile Mayrisch, Esch-sur-Alzette, Luxembourg
+9 https://ror.org/04y798z66 grid.419123.c 0000 0004 0621 5272 Laboratoire National de Santé, Dudelange, Luxembourg
+10 Association of Physiotherapists in Parkinson’s Disease Europe, Esch-sur-Alzette, Luxembourg
+11 https://ror.org/036x5ad56 grid.16008.3f 0000 0001 2295 9843 Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
+12 https://ror.org/02d9ce178 grid.412966.e 0000 0004 0480 1382 Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands
+13 Private Practice, Ettelbruck, Luxembourg
+14 Parkinson Luxembourg Association, Leudelange, Luxembourg
+15 Luxembourg Center of Neuropathology, Dudelange, Luxembourg
+16 https://ror.org/036x5ad56 grid.16008.3f 0000 0001 2295 9843 Department of Life Sciences and Medicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
+17 Private Practice, Luxembourg, Luxembourg
+Electronic publication date: 2025 Nov 7
+Publication date: 2025
+Volume: 8
+Electronic Location ID: 645
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Integrating digital gait data with metabolomics and clinical data to predict outcomes in Parkinson’s disease 7 6 9 2024 235 NPJ Digital Medicine 10.1038/s41746-024-01236-z PMC11379877 39242660
+Keywords: Parkinson's disease, Diagnostic markers
+issue-copyright-statement: © Springer Nature Limited 2025
+
+Ÿ==============================Ÿ
+Correction to: npj Digital Medicine 10.1038/s41746-024-01236-z, published online 06 September 2024
+
+In this article, NCER-PD consortium members Dr. Stefano Sapienza and Prof. Dr. Jochen Klucken meet the authorship criteria. Therefore, their names have been included in the author list. The original article has been corrected.
+
diff --git a/corpus/healthcare/text/2ebdf3e008aec639.txt b/corpus/healthcare/text/2ebdf3e008aec639.txt
new file mode 100644
index 0000000000000000000000000000000000000000..168da87912594ffb54d4c38d0cd85c439ac798d1
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+++ b/corpus/healthcare/text/2ebdf3e008aec639.txt
@@ -0,0 +1,740 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13384304
+PMID: 42475342
+DOI: 10.1371/journal.pone.0352973
+Article ID: PONE-D-26-18433
+Article version: 1
+Subjects: Registered Report Protocol, Medicine and health sciences, Public and occupational health, Preventive medicine, HIV prevention, Social Sciences, Sociology, Education, Schools, Medicine and Health Sciences, Diagnostic Medicine, Virus Testing, Research and Analysis Methods, Database and Informatics Methods, Database Searching, Biology and Life Sciences, Microbiology, Medical Microbiology, Microbial Pathogens, Viral Pathogens, Immunodeficiency Viruses, HIV, Medicine and Health Sciences, Pathology and Laboratory Medicine, Pathogens, Microbial Pathogens, Viral Pathogens, Immunodeficiency Viruses, HIV, Biology and Life Sciences, Organisms, Viruses, Viral Pathogens, Immunodeficiency Viruses, HIV, Biology and Life Sciences, Organisms, Viruses, Immunodeficiency Viruses, HIV, Biology and life sciences, Organisms, Viruses, RNA viruses, Retroviruses, Lentivirus, HIV, Biology and Life Sciences, Microbiology, Medical Microbiology, Microbial Pathogens, Viral Pathogens, Retroviruses, Lentivirus, HIV, Medicine and Health Sciences, Pathology and Laboratory Medicine, Pathogens, Microbial Pathogens, Viral Pathogens, Retroviruses, Lentivirus, HIV, Biology and Life Sciences, Organisms, Viruses, Viral Pathogens, Retroviruses, Lentivirus, HIV, Medicine and Health Sciences, Public and Occupational Health, Preventive Medicine, Prophylaxis, Pre-Exposure Prophylaxis, People and Places, Population Groupings, Age Groups, Children, Adolescents, People and Places, Population Groupings, Families, Children, Adolescents, Medicine and Health Sciences, Epidemiology, Medical Risk Factors
+
+Integrating biomedical HIV prevention in schools: Protocol for a systematic review of interventions for adolescent girls and young women in sub-Saharan Africa
+
+Biomedical HIV prevention in schools for adolescent girls and young women in sub-Saharan Africa
+
+https://orcid.org/0009-0004-7465-2498 Lodonu-Senoo Cecilia Afua Conceptualization Formal analysis Methodology Writing – original draft 1 *
+Ogyiri Lily Formal analysis Methodology Writing – original draft 2
+Torpey Kwasi Conceptualization Methodology Supervision Writing – review & editing 3
+Zotor Francis Conceptualization Methodology Supervision Writing – review & editing 1
+1 Department of Family and Community Health, Fred N. Binka School of Public Health, University of Health and Allied Sciences, Hohoe, Volta Region, Ghana
+2 Department of Public Health, Robbins College of Health and Human Sciences, Baylor University, Waco, Texas, United States of America
+3 Department of Population, Family and Reproductive Health, School of Public Health, University of Ghana, Accra, Greater Accra Region, Ghana
+Badru Oluwaseun Abdulganiyu Editor
+The University of Iowa College of Public Health, UNITED STATES OF AMERICA
+Competing Interests: The authors have no competing interest.
+
+* E-mail: ceciliasenoo@gmail.com
+Electronic publication date: 2026 Jul 20
+Publication date: 2026
+Volume: 21
+Issue: 7
+Electronic Location ID: e0352973
+Received 2026 May 5; Accepted 2026 Jun 17
+Copyright: © 2026 Lodonu-Senoo et al
+Copyright year: 2026
+Copyright holder: Lodonu-Senoo et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Integrating biomedical HIV prevention in schools: Protocol for a systematic review of interventions for adolescent girls and young women in sub-Saharan Africa. 21 7 20 7 2026 e0352973 e0352973 PLoS One 10.1371/journal.pone.0352973 42475342
+Integrating biomedical HIV prevention in schools: Protocol for a systematic review of interventions for adolescent girls and young women in sub-Saharan Africa. 21 7 20 7 2026 e0352973 e0352973 PLoS One 10.1371/journal.pone.0352973 42475342
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 1
+Table count: 4
+Page count: 10
+Data Availability: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
+
+Data Availability
+
+No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
+
+Ÿ==============================Ÿ
+Introduction
+
+Despite global progress in reducing HIV incidence, adolescent girls and young women in sub-Saharan Africa remain disproportionately affected. Biomedical HIV prevention tools such as pre-exposure prophylaxis, condoms and HIV testing are effective but underutilized, especially within facility-based models. Schools represent consistent and scalable contact points for reaching adolescent girls and young women, yet evidence on the feasibility, accessibility and effectiveness of school-based biomedical HIV prevention interventions remains limited.
+
+Objective
+
+This systematic review aims to synthesize evidence on how school-based programs implement, deliver and achieve outcomes in HIV prevention interventions involving pre-exposure prophylaxis, condom and HIV testing for adolescent girls and young women in sub-Saharan Africa.
+
+Materials and methods
+
+This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. Eligible studies will include randomized and non-randomized trials and qualitative research published between January 2015 and December 2025. Databases to be searched include PubMed, Embase, PsycINFO, CINAHL and the African Index Medicus, together with relevant grey literature sources (WHO, UNAIDS, UNICEF and PEPFAR). Two reviewers will independently screen titles, abstracts, and full texts, extract data, and assess risk of bias using appropriate tools. Quantitative data will be synthesized using meta-analysis where feasible, while qualitative findings will undergo thematic synthesis. Outcomes of interest include the feasibility, accessibility, and effectiveness of school-based HIV prevention interventions.
+
+Discussion
+
+This review will provide a comprehensive synthesis of evidence on biomedical HIV prevention interventions delivered in school settings for adolescent girls and young women in sub-Saharan Africa. Findings will highlight implementation process, barriers, facilitators and equity considerations.
+
+Trial registration number: PROSPERO CRD420251249595
+
+Introduction
+
+Global progress in human immunodeficiency virus (HIV) prevention has accelerated in recent years, with the year 2024 recording a 40% reduction in incidence compared to 2010. However, an estimated 1.3 million people acquired HIV in 2024, nearly three times the global target of fewer than 370,000 new infections by 2025 [1]. Sub-Saharan Africa accounted for half of all new infections, even as the region experienced the steepest decline globally, a 56% decrease in incidence over the same period [1].
+
+Adolescent girls and young women (AGYW) remain disproportionately affected. HIV incidence among AGYW is more than three times higher than that of their male peers [1]. Although global targets aimed to reduce new infections among AGYW to less than 50,000 by 2025, an estimated 210,000 AGYW acquired HIV in 2024 [1]. In eastern and southern Africa, the estimated number of new HIV infections among AGYW was 140,000, and in western and central Africa it was 31,000 [1]. This persistent vulnerability reflects deep-rooted gender inequalities, power imbalances, restrictive social norms, stigma, discrimination, criminalization, violence and socioeconomic inequalities across sub-Saharan Africa, which collectively limit AGYW’s ability to negotiate safer sex, access services, and exercise sexual autonomy [1,2].
+
+Despite the availability of effective prevention tools, uptake is inadequate. Condom use, one of the most cost-effective HIV prevention strategies, remains suboptimal due to stigma, limited access, gendered power dynamics, and scarcity of youth-friendly service environments [3–5]. Likewise, biomedical HIV preventions options such as pre-exposure prophylaxis (PrEP), condom distribution and HIV testing, have expanded the prevention landscape, yet their uptake among AGYW is suboptimal, especially within traditional facility-based models [1].
+
+Schools represent one of the most consistent and scalable contact points for reaching AGYW in sub-Saharan Africa. They offer access to large cohorts of adolescents in a structured setting and can serve as effective entry points for integrated sexual and reproductive health interventions. Evidence demonstrates that educational programmes can enhance HIV-related knowledge, build agency, and promote protective behaviours among adolescents [6,7]. However, curriculum-based HIV education alone has shown limited effectiveness in reducing HIV incidence or maintaining behaviour change without complementary access to prevention services [8,9].
+
+Emerging research suggests that schools may also be promising delivery sites for biomedical HIV prevention interventions such as PrEP, condom distribution, and HIV testing. Studies have reported higher PrEP uptake in school-based or school-linked delivery models compared to community or clinic-based approaches [10]. Qualitative research further indicates that comfort, accessibility, trust, and peer support facilitate PrEP initiation among AGYW in school environments [11]. This suggests that integrating biomedical prevention within school settings may help overcome many of the barriers that limit AGYW’s access to facility-based services.
+
+Existing reviews have focused largely on sexual and reproductive health education, abstinence-only, or broader behavioural interventions, with limited attention to school-based biomedical or service-oriented HIV prevention initiatives and their implementation outcomes [8,12–14].
+
+This systematic review will address this gap by synthesizing quantitative and qualitative evidence to understand what works, what is feasible, and what barriers and facilitators influence the implementation of school-based HIV prevention initiatives, including PrEP, condom, and HIV testing for AGYW in sub-Saharan Africa. The findings will inform programme design, implementation, and scale-up of efforts aimed at reducing HIV incidence among AGYW.
+
+Objective
+
+To synthesize evidence on how school-based programs are implemented, delivered, and achieve outcomes in HIV prevention interventions (involving PrEP, condom and HIV testing) for AGYW in sub-Saharan Africa.
+
+Review questions.
+
+What is known about the feasibility of implementing PrEP, condom or HIV testing interventions in school settings in sub-Saharan Africa?
+
+What evidence exists on the accessibility of such interventions among AGYW?
+
+How effective are these interventions at improving HIV prevention outcomes?
+
+Materials and methods
+
+This protocol was developed using the Preferred Reporting Items for Systematic reviews and Meta-Analyses Protocols (PRISMA-P) checklist.
+
+Eligibility criteria
+
+For this review, biomedical HIV prevention interventions refer to school-based interventions that provide, deliver, or facilitate access to PrEP, condoms, or HIV testing services.
+
+Selected studies will be based on the eligibility criteria outlined in Table 1:
+
+10.1371/journal.pone.0352973.t001 Table 1 Study eligibility criteria.
+
+Component	Include	Exclude	
+Population	AGYW, aged 10–24 years, enrolled in schools in sub-Saharan Africa	Studies focused exclusively on boys or adult women,
+
+Out-of-school youth
+
+Studies not disaggregating AGYW data
+
+Studies conducted outside sub-Saharan Africa	
+Intervention	School-based HIV prevention programs that include at least one of the following: PrEP education/delivery, condom promotion/distribution, or HIV testing/counselling (in-school or linked to external services)	No intervention,
+
+Interventions delivered solely in community or clinic settings without school linkage
+
+Interventions limited to general life skills or abstinence-only programs without biomedical or service components.	
+Outcomes	Feasibility, accessibility, effectiveness	Studies reporting only process indicators without implementation or effectiveness outcomes	
+Study design	Randomized-controlled trials, Cluster-randomized trials
+
+Quasi-experimental studies,
+
+Cohort/longitudinal, implementation studies, mixed-methods studies, qualitative studies	Editorials, commentaries, reviews	
+Context	Formal educational institutions (e.g., public, private, faith-based, vocational schools) in sub-Saharan Africa	Non-school settings (e.g., community centres, Clinics, households)	
+Time Frame	Studies published between January 2015 and December 2025	Studies published before 2015	
+Language	English	Non-English publications	
+
+Information sources
+
+Search strategy.
+
+We will search multiple online databases to identify peer-reviewed articles and grey literature. The following databases will be searched:
+
+PubMed through the PubMed interface using MeSH terms and keywords
+
+Embase via Elsevier using Emtree Terms and keywords
+
+PsycINFO via EBSCOhost using APA Thesaurus and keywords
+
+CINAHL via EBSCOhost using CINAHL Subject Headings and keywords
+
+African Index Medicus via WHO AIM portal using keywords
+
+Grey literature: WHO, UNAIDS, UNICEF, PEPFAR
+
+The search will be restricted to studies published between January 2015 and December 2025. The year 2015 was selected because it coincides with major developments in global HIV prevention policy and programming. In 2015, the United Nations adopted the Sustainable Development Goals (SDGs), which included a commitment to end the AIDS epidemic as a public health threat by 2023. That same year, the World Health Organization (WHO) recommended the broader use of oral PrEP for populations with substantial risk of HIV infection [15,16]. Restricting the review to studies published between 2015 and 2025 ensures that the evidence reflects contemporary HIV prevention policies, service delivery models, and implementation approaches. Due to resource constraints and the absence of multilingual screening and data extraction capacity, the review will be limited to studies published in English. Table 2 presents an example of the search strategy to be used in PubMed.
+
+10.1371/journal.pone.0352973.t002 Table 2 Search strategy in PubMed.
+
+Search	Search term	
+1	“Schools” [MeSH] OR school-based [tw] OR school* [tw] OR education* [tw] OR classroom*[tw] OR academic* [tw] OR campus* [tw] OR secondary school [tw] OR high school [tw]	
+2	“HIV infections/prevention and control” [MeSH] OR “HIV Testing” [MeSH] OR “Condoms” [MeSH] OR “Pre-Exposure Prophylaxis” [MeSH] OR “Sexual Health/education” [MeSH] OR “Student Health Services” [MeSH] OR HIV prevention[tw] OR HIV testing[tw] OR PrEP [tw]	
+3	“Adolescent” [MeSH] OR “Young Adult” [MeSH] OR “Female” [MeSH] OR “Students” [MeSH] OR adolescent girls[tw] OR young women [tw] OR AGYW [tw] OR teen* [tw] OR youth [tw] OR student* [tw]	
+4	“sub-Saharan Africa”[tw] OR “Africa South of the Sahara” [MeSH] OR Angola [tw] OR Benin[tw] OR Botswana [tw] OR “Burkina Faso”[tw] OR Burundi [tw] OR Cameroon [tw] OR “Cape Verde” [tw] OR Cabo Verde[tw] OR “Central African Republic” [tw] OR Chad [tw] OR Comoros [tw] OR Congo [tw] OR “Democratic Republic of the Congo” [tw] OR Djibouti [tw] OR “Equatorial Guinea” [tw] OR Eritrea [tw] OR Ethiopia [tw] OR Gabon [tw] OR Gambia [tw] OR Ghana [tw] OR Guinea [tw] OR “Guinea Bissau” [tw] OR “Ivory Coast” [tw] OR “Cote d’Ivoire” [tw] OR Kenya [tw] OR Lesotho [tw] OR Liberia [tw] OR Madagascar [tw] OR Malawi [tw] OR Mali [tw] OR Mauritania [tw] OR Mauritius [tw] OR Mozambique [tw] OR Namibia [tw] OR Niger [tw] OR Nigeria [tw] OR Rwanda [tw] OR “Sao Tome” [tw] OR Senegal [tw] OR Seychelles [tw] OR “Sierra Leone” [tw] OR Somalia [tw] OR “South Africa” [tw] OR “South Sudan” [tw] OR Sudan [tw] OR Swaziland [tw] OR Eswatini[tw] OR Tanzania [tw] OR Togo [tw] OR Uganda [tw] OR “Western Sahara” [tw] OR Zaire [tw] OR Zambia [tw] OR Zimbabwe [tw]	
+5	#1 AND #2 AND #3 AND #4	
+6	#5 Limits: 01/01/2015 to 31/12/2025, studies in English	
+
+Study records
+
+Data management.
+
+All records identified through database searches will be imported into Zotero for reference management. Full-text articles will be downloaded and stored locally, organized by first author surname and year of publication. Extracted data, reviewer decisions, and synthesis outputs will be archived across platforms to ensure transparency and reproducibility.
+
+Study selection and data extraction.
+
+Title/abstract screening and full-text review will be conducted using Rayyan, a web-based tool designed to facilitate blinded and collaborative screening. Two reviewers will independently screen each record against the predefined eligibility criteria. Disagreements will be resolved through discussion or adjudication by a third reviewer. Full-text screening will follow the same dual-review process within Rayyan, with exclusion reasons documented systematically.
+
+Studies meeting the eligibility criteria will undergo data extraction, which will be conducted independently by two reviewers using a structured template aligned with the review’s objectives. Conflicts will be discussed and resolved between the two reviewers, and where resolution cannot be reached, a third reviewer will be involved to decide. RevMan will be used to facilitate data extraction, risk of bias assessment and data synthesis.
+
+The reference lists of all included studies will be screened to identify additional eligible studies not captured through the database search.
+
+When relevant data are missing or unclear, the corresponding author of the article will be contacted to request additional information. The study selection process will be reported using the PRISMA flow diagram (Fig 1).
+
+10.1371/journal.pone.0352973.g001 Fig 1 PRISMA flow diagram.
+
+Data items.
+
+Implementation outcomes will be assessed according to the implementation science frameworks by Proctor and colleagues [17] and adapted to the school-based HIV prevention context. For this review:
+
+Feasibility refers to the extent to which the intervention can be delivered within school settings as intended, including logistics, staffing, training, fidelity, and integration into school routines.
+
+Accessibility refers to the degree to which AGYW can access and use the intervention, including acceptability, uptake, privacy, confidentiality, perceived appropriateness, and equity of access.
+
+Effectiveness (implementation-linked) refers to biomedical or behavioural outcomes directly related to intervention delivery, such as HIV testing uptake, PrEP initiation or continuation, and condom uptake or use. These outcomes reflect real-world effects of implementation rather than clinical efficacy.
+
+Secondary implementation outcomes include cost and cost-effectiveness, sustainability or maintenance, engagement of school personnel or parents, and contextual barriers and facilitators such as gender norms, stigma, or school policies.
+
+The list of variables to be extracted and their definitions are presented in Table 3.
+
+10.1371/journal.pone.0352973.t003 Table 3 List and definitions of all variables for which data will be sought.
+
+Variable	Definition	
+Characteristics of the study	
+Authors	First author and co-authors	
+Year	Year of publication	
+Country/region	Country or region within sub-Saharan Africa	
+Design	Study design	
+Setting	Type of school or educational institution	
+Sample size	Number of participants or clusters	
+Duration	Length of follow-up or intervention period	
+Funding source	Private sector or Government	
+Population and Implementation Variables	
+Population	Adolescent and young women in sub-Saharan Africa	
+Age range	Specific age range of participants included in the study	
+Intervention	Type of intervention: condom-related, PrEP-related, HIV testing, or linkage to external services	
+Comparator	Standard curriculum, community-only interventions, no intervention, other school-based strategies	
+Delivery personnel	Who implemented the intervention (teachers, health workers, etc)	
+Mode of delivery	Format of intervention delivery	
+Engagement	Level of involvement of school staff, parents, community leaders or AGYW themselves	
+Barriers and facilitators	Contextual factors influencing implementation (e.g., gender norms, power dynamics, structural factors)	
+Main Outcome variables (high priority)	
+Feasibility	Implementation, logistics, training fidelity to protocol	
+Accessibility	Acceptability, uptake, equity, privacy	
+Effectiveness	Biomedical/behavioural outcomes like HIV testing uptake, PrEP initiation, condom use	
+Additional outcomes (moderate priority)	
+Secondary implementation outcomes	Cost and cost-effectiveness, sustainability/maintenance	
+Knowledge and awareness	Changes in HIV -related knowledge or awareness, risk perception	
+Behavioural intentions	Intentions for condom use, PrEP, HIV testing	
+Adverse events or harm	Reported negative outcomes	
+
+Risk of bias assessment
+
+Quality appraisal for randomized trials will be conducted using the Cochrane Collaboration Risk of Bias (ROB 2) tool, including the extension for cluster-randomized trials. For quasi-experimental trials and cohort studies, the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool will be used. The CASP qualitative checklist will be used to appraise qualitative studies, and the Mixed Methods Appraisal Tool will be used for mixed-methods studies. Two reviewers will independently assess risk of bias. Disagreements will be resolved through discussion, and where consensus cannot be reached, a third reviewer will be consulted.
+
+Data synthesis
+
+A descriptive synthesis of all included studies, summarizing intervention types, outcomes and other study characteristics will be presented using structured tables and narrative summaries. Quantitative and qualitative data will be analysed separately before integration.
+
+Quantitative findings will be synthesized using meta-analysis where appropriate, or narratively when heterogeneity precludes statistical pooling. Meta-analysis will be conducted for feasibility, accessibility, and effectiveness outcomes when at least two studies report comparable measures using sufficiently similar definitions, and are sufficiently similar in terms of intervention characteristics, participant population, outcome definitions, and study design. Feasibility outcomes may include implementation fidelity, recruitment, retention, and intervention delivery indicators. Accessibility outcomes may include acceptability, uptake, reach, privacy, and equity-related indicators. Effectiveness outcomes may include HIV testing uptake, PrEP initiation or adherence and condom use. Where sufficient data are available, pooled analyses may be conducted for outcomes such as HIV testing uptake, PrEP initiation, condom use, intervention acceptability, intervention uptake and retention in prevention programs. Binary outcomes will be summarized using risk ratios, odds ratios, or risk differences; continuous outcomes using mean differences or standardized mean differences, and time-to-event outcomes using hazard ratios. A random-effects model will be used as a default analytic approach, with heterogeneity assessed using the I2 statistic and Chi-square test. Where at least 10 studies contribute data, subgroup analyses will be conducted by intervention type, delivery setting and predefined age groups. Subgroup analyses will be conducted for predefined age groups (10–14, 15–19 and 20–24 years) when sufficient studies report age-disaggregated data, to examine whether implementation outcomes differ across developmental stages. Meta-regression may be used to explore potential sources of heterogeneity. Sensitivity analyses will examine the influence of excluding studies at high risk of bias or those with missing data. If meta-regression is not feasible due to variability in study design or outcome measurement, findings will be presented narratively. Narrative synthesis will involve grouping studies by intervention type and outcome domain and summarizing results thematically.
+
+Qualitative data will be synthesized thematically using inductive and deductive coding. Themes will be organized under feasibility, accessibility, and effectiveness to align with the review’s core domains. Integration will occur at the interpretive level, with narrative juxtaposition of quantitative and qualitative findings to identify convergence, divergence, and contextual insights relevant to implementation.
+
+Publication bias will be assessed using funnel plots and statistical tests for small-study effects (e.g., Egger’s or Begg’s test), where applicable. Quantitative synthesis will be carried out in RevMan, and qualitative synthesis in Excel.
+
+Confidence in cumulative evidence
+
+Two independent reviewers will use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to determine the certainty of evidence. Conflicts will be resolved through discussion, and a third reviewer will be involved where agreement cannot be reached.
+
+Ethical considerations
+
+This is a systematic review of published and publicly available literature. Hence, it will not involve primary data collection with human participants and does not require formal ethical approval. All data will be extracted from existing studies, and no individual participant information will be identifiable. This review will be conducted in accordance with PRISMA-P guidelines to ensure transparency, reproducibility, and integrity throughout the process.
+
+Status and timeline of the study
+
+Table 4 summarizes the planned timeline for screening, data extraction, analysis and expected completion of the study.
+
+10.1371/journal.pone.0352973.t004 Table 4 Study timeline.
+
+Review stage	Status at submission	Planned timeline	
+Protocol development	Completed	Completed prior to submission	
+Database search	Not yet started	June 2026	
+Title/abstract screening	Not yet started	June – July 2026	
+Full-text screening	Not yet started	August 2026	
+Data extraction	Not yet started	September – October 2026	
+Risk of bias assessment	Not yet started	September – October 2026	
+Data analysis and synthesis	Not yet started	November – December 2026	
+Report writing and dissemination	Not yet started	December 2026 – February 2027	
+
+Discussion
+
+This systematic review will synthesize evidence on school-based HIV prevention interventions targeting AGYW in sub-Saharan Africa. Implementation of these interventions is often shaped by contextual factors, including stigma, policy constraints, and resource availability.
+
+By focusing on studies conducted within educational institutions, this review aims to clarify what works in integrating biomedical HIV prevention into school settings and to clarify implementation bottlenecks and equity gaps. The inclusion of both quantitative and qualitative components will allow for a nuanced understanding of not only outcomes but also implementation processes, barriers and facilitators.
+
+Potential limitations include variability in study design, outcome definitions, and measurement tools, which may limit the feasibility of meta-analysis. Restricting the review to English-language publications may introduce language bias and may result in the exclusion of relevant studies from francophone and lusophone countries in sub-Saharan Africa. This limitation reflects resource constraints, and the findings should be interpreted in light of this.
+
+Ultimately, this review will contribute to the evidence base for equity-driven HIV prevention programming in schools, helping to inform future research, policy, and practice at reducing HIV vulnerability among AGYW in sub-Saharan Africa.
+
+Supporting information
+
+S1 Table PRISMA-P checklist.
+
+(DOCX)
+
+DOI: 10.1371/journal.pone.0352973.r001
+
+Decision Letter 0
+
+Badru Oluwaseun Academic Editor
+Copyright: © 2026 Oluwaseun Badru
+Copyright year: 2026
+Copyright holder: Oluwaseun Badru
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 0
+
+29 May 2026
+
+-->PONE-D-26-18433-->-->Integrating biomedical HIV prevention in schools: Protocol for a systematic review of interventions for Adolescent Girls and Young Women in Sub-Saharan Africa-->-->PLOS One
+
+Dear Dr. Lodonu-Senoo,
+
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+==============================
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+This proposed systematic review is crucial in the context of biomedical intervention
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+Reviewers' comments:
+
+Reviewer's Responses to Questions
+
+-->Comments to the Author
+
+1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?
+
+The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.-->
+
+Reviewer #1: Yes
+
+Reviewer #2: Yes
+
+**********
+
+-->2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?
+
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+
+Reviewer #1: Yes
+
+Reviewer #2: Yes
+
+**********
+
+-->3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?-->
+
+Reviewer #1: No
+
+Reviewer #2: Yes
+
+**********
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+
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+**********
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+Reviewer #1: Yes
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+
+**********
+
+-->6. Review Comments to the Author
+
+Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.
+
+You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.
+
+(Please upload your review as an attachment if it exceeds 20,000 characters)-->
+
+Reviewer #1: The manuscript presents a generally relevant and timely rationale for examining the integration of biomedical HIV prevention interventions within school settings for adolescent girls and young women, particularly given the ongoing burden of HIV in this population and the importance of school platforms for prevention delivery. However, the justification for the proposed research questions and eligibility criteria would benefit from further refinement. In particular, the inclusion of a broad age range (10–24 years) is not fully aligned with a school-based intervention focus and introduces substantial heterogeneity across distinct developmental, educational, and service-access stages. Early adolescents (10–14 years), mid-to-late adolescents (15–19 years), and young adults (20–24 years) differ meaningfully in terms of school exposure, sexual and reproductive health needs, and relevance to biomedical HIV prevention interventions. As currently framed, the criteria risk conflating populations for whom school-based biomedical integration may be variably applicable or minimally relevant, particularly at the younger end of the spectrum. The authors should either provide a clearer justification for maintaining this broad age range, including a plan for stratified analysis by age/education stage, or consider narrowing the population to better reflect school-attending secondary school-aged adolescents, where the intervention context is most coherent.
+
+Reviewer #2: The protocol addresses a highly relevant and timely public health issue. The focus on school-based biomedical HIV prevention for adolescent girls and young women in sub-Saharan Africa addresses an important evidence gap, particularly given the continued disproportionate burden of HIV in this population. It is also well-structured and aligned with PRISMA-P guidelines, with notable strengths including the inclusion of both quantitative and qualitative evidence, the use of established risk-of-bias tools, and the focus on implementation outcomes.
+
+To further strengthen the manuscript, the following suggestions may be considered:
+
+Introduction/ Methods
+
+1. Some terms such as ‘biomedical HIV prevention’ and ‘implementation outcomes’ could be defined more clearly to improve clarity and help readers better understand the scope of the review.
+
+Methods
+
+1. The outcomes section could benefit from further clarification. While biological and behavioural outcomes appear to be excluded in the eligibility criteria, they are later mentioned under effectiveness outcomes. Clarifying how effectiveness will be assessed would improve consistency.
+
+2. It would be useful to briefly explain the rationale for limiting the review to studies published between 2015 and 2025, particularly whether this relates to important policy developments such as WHO PrEP guideline updates or the SDG era.
+
+3. The search strategy could be strengthened. Using “Africa” alone may retrieve studies outside sub-Saharan Africa.
+
+4. The risk of bias section could be strengthened by specifying which appraisal tools will be used for each study design and how disagreements between reviewers will be resolved.
+
+5. The data synthesis section would benefit from a little more detail regarding which outcomes will be pooled, the effect measures to be used, how heterogeneity will be assessed, and under what conditions meta-analysis will be conducted
+
+6. Restricting the review to English-language publications may exclude relevant studies from francophone and lusophone countries within sub-Saharan Africa. The authors may wish to consider including studies published in other languages where feasible, using available translation tools or multilingual support to minimize language bias and improve the comprehensiveness of the review.
+
+**********
+
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+
+Reviewer #1: Yes: Pelisa Nongena
+
+Reviewer #2: No
+
+**********
+
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+Attachment Submitted filename: PONE-D-26-18433_reviewed.docx
+
+DOI: 10.1371/journal.pone.0352973.r002
+
+Author response to Decision Letter 1
+
+Submission Version: 1
+
+16 Jun 2026
+
+Dear Academic Editor and Reviewers,
+
+We sincerely thank the Academic Editor and Reviewers for their thoughtful and constructive comments. We appreciate the positive assessment of the relevance and potential contribution of this protocol. We have carefully revised the manuscript to address all comments and believe that these revisions have strengthened the clarity, transparency, and reproducibility of the proposed review. Below, we provide a detailed point-by-point response.
+
+Academic Editor
+
+Comment:
+
+Please address the reviewer comments adequately, in particular the language restriction and age range.
+
+Response:
+
+We thank the Academic Editor for this recommendation. We have addressed all comments raised by the reviewers. We have provided additional justification for retaining the age range of 10–24 years and have incorporated plans for subgroup analyses by age category (10–14, 15–19, and 20–24 years) where sufficient data are available. We have expanded the discussion of language restrictions and explicitly acknowledge the potential for language bias resulting from the inclusion of English-language publications only. We have also explained that resource constraints preclude reliable screening and extraction of non-English studies.
+
+Journal requirements
+
+Comment 1:
+
+Please ensure that the manuscript meets PLOS ONE style requirements, including those for file naming.
+
+Response:
+
+The manuscript has been reviewed and revised to ensure compliance with PLOS ONE formatting and style requirements.
+
+Comment 2:
+
+Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript.
+
+Response:
+
+The ethics statement has been retained only within the Methods section and removed from any other sections of the manuscript.
+
+Comment 3:
+
+Please provide a complete Data Availability Statement in the submission form, ensuring you include all necessary access information or a reason for why you are unable to make your data freely accessible. If your research concerns only data provided within your submission, please write "All data are in the manuscript and/or supporting information files" as your Data Availability Statement.
+
+Response:
+
+The Data Availability Statement has been revised to indicate that all data are in the manuscript and/or supporting information files.
+
+Comment 4:
+
+Please ensure that you refer to Figure 1 in your text as, if accepted, production will need this reference to link the reader to the figure.
+
+Response:
+
+An explicit reference to Figure 1 has been added within the Study Selection section.
+
+Comment 5:
+
+We note you have included a table to which you do not refer in the text of your manuscript. Please ensure that you refer to Table 3 in your text; if accepted, production will need this reference to link the reader to the Table.
+
+Response:
+
+An explicit reference to Table 3 has been added within the Data Items section.
+
+Comment 6:
+
+We notice that your supplementary figures are uploaded with the file type 'Figure'. Please amend the file type to 'Supporting Information'. Please ensure that each Supporting Information file has a legend listed in the manuscript after the references list.
+
+Response:
+
+We thank the editorial team for noting the file type issue. The figure in question was mistakenly uploaded as Supporting Information. We have corrected this by re uploading it as a main text figure and removing it from the Supporting Information files.
+
+REVIEWER #1
+
+Comment:
+
+The manuscript presents a generally relevant and timely rationale for examining the integration of biomedical HIV prevention interventions within school settings for adolescent girls and young women, particularly given the ongoing burden of HIV in this population and the importance of school platforms for prevention delivery. However, the justification for the proposed research questions and eligibility criteria would benefit from further refinement. In particular, the inclusion of a broad age range (10–24 years) is not fully aligned with a school-based intervention focus and introduces substantial heterogeneity across distinct developmental, educational, and service-access stages. Early adolescents (10–14 years), mid-to-late adolescents (15–19 years), and young adults (20–24 years) differ meaningfully in terms of school exposure, sexual and reproductive health needs, and relevance to biomedical HIV prevention interventions. As currently framed, the criteria risk conflating populations for whom school-based biomedical integration may be variably applicable or minimally relevant, particularly at the younger end of the spectrum. The authors should either provide a clearer justification for maintaining this broad age range, including a plan for stratified analysis by age/education stage, or consider narrowing the population to better reflect school-attending secondary school-aged adolescents, where the intervention context is most coherent.
+
+Response:
+
+We thank the reviewer for this thoughtful observation. We have retained the 10–24-year age range because it aligns with global definitions of adolescents and young people used by WHO and UNAIDS, and because school-based and school-linked HIV prevention interventions in sub-Saharan Africa frequently reach individuals across this span, including early adolescents in upper primary school, secondary school students, and young adults enrolled in post-secondary or vocational institutions.
+
+However, we agree that developmental and educational stages differ meaningfully within this range. To address concerns regarding heterogeneity, we have revised the Data Synthesis section to specify that subgroup analyses will be conducted by age category (10–14 years, 15–19 years, and 20–24 years) where sufficient studies are available. This approach preserves conceptual coherence while allowing us to capture the full range of school-attending populations targeted by HIV prevention programs in the region.
+
+REVIEWER #2
+
+Introduction/Methods
+
+Comment 1:
+
+Some terms such as ‘biomedical HIV prevention’ and ‘implementation outcomes’ could be defined more clearly to improve clarity and help readers better understand the scope of the review.
+
+Response:
+
+We appreciate this helpful suggestion. We have clarified these terms within the Methods section. Specifically, we added an operational definition stating that, for the purposes of this review, biomedical HIV prevention interventions refer to school-based interventions that provide, deliver or facilitate access to PrEP, condoms or HIV testing services. We also expanded the description of implementation-related outcomes, including feasibility, accessibility and effectiveness domains to improve clarity regarding the scope of the review.
+
+Methods
+
+Comment 1:
+
+The outcomes section could benefit from further clarification. While biological and behavioural outcomes appear to be excluded in the eligibility criteria, they are later mentioned under effectiveness outcomes. Clarifying how effectiveness will be assessed would improve consistency.
+
+Response:
+
+Thank you for this helpful observation. We agree that the presentation of outcomes in the eligibility table may have created ambiguity. To improve clarity and ensure consistency across sections, we have revised the eligibility criteria by removing the reference to biological and behavioural outcomes from the inclusion table. These outcomes are now described exclusively under the Data Items section, where we provide operational definitions of feasibility, accessibility, and effectiveness. We also added a clarifying statement to specify that biomedical and behavioural measures (e.g., HIV testing uptake, PrEP initiation, condom use) will be assessed as effectiveness outcomes, reflecting real world effects of intervention delivery.
+
+These revisions ensure that the eligibility criteria focus solely on the types of outcomes required for inclusion, while the Data Items and Outcomes sections clearly describe how effectiveness will be assessed.
+
+Comment 2:
+
+It would be useful to briefly explain the rationale for limiting the review to studies published between 2015 and 2025, particularly whether this relates to important policy developments such as WHO PrEP guideline updates or the SDG era
+
+Response:
+
+We have added a justification for the selected timeframe within the Search Strategy section. Specifically, we note that 2015 coincided with the adoption of the Sustainable Development Goals and WHO recommendations supporting broader use of oral PrEP among populations at substantial risk of HIV infection.
+
+Comment 3:
+
+The search strategy could be strengthened. Using “Africa” alone may retrieve studies outside sub-Saharan Africa.
+
+Response:
+
+We agree and have revised the search strategy accordingly. The standalone term “Africa” has been removed from the search strategy.
+
+Comment 4:
+
+The risk of bias section could be strengthened by specifying which appraisal tools will be used for each study design and how disagreements between reviewers will be resolved.
+
+Response:
+
+We appreciate this helpful suggestion. The Risk of Bias Assessment section has been expanded to specify the appraisal tool that will be used for each study design. We also clarify that risk-of-bias assessments will be conducted independently by two reviewers, with disagreements resolved through discussion and consultation with a third reviewer when necessary.
+
+Comment 5:
+
+The data synthesis section would benefit from a little more detail regarding which outcomes will be pooled, the effect measures to be used, how heterogeneity will be assessed, and under what conditions meta-analysis will be conducted
+
+Response:
+
+We appreciate this helpful suggestion and have revised the manuscript accordingly. We have expanded the Data Synthesis section. The revised text now specifies the types of outcomes that may be pooled, including feasibility, accessibility, and effectiveness outcomes; the effect measures that will be used for binary, continuous, and time-to-event outcomes; the methods for assessing heterogeneity using the I² statistic and Chi-square test; and the conditions under which meta-analysis, subgroup analyses, sensitivity analyses, and narrative synthesis will be conducted.
+
+Comment 6:
+
+Restricting the review to English-language publications may exclude relevant studies from francophone and lusophone countries within sub-Saharan Africa. The authors may wish to consider including studies published in other languages where feasible, using available translation tools or multilingual support to minimize language bias and improve the comprehensiveness of the review.
+
+Response:
+
+We thank the reviewer for this important observation. We acknowledge that restricting the review to English-language publications may result in exclusion of relevant evidence from francophone and lusophone countries in sub-Saharan Africa and may introduce language bias. However, resource constraints and the absence of multilingual screening and data extraction capacity preclude the reliable assessment of non-English studies. We revised the Discussion section to explicitly acknowledge the potential for language bias and its implications for the comprehensiveness of the review.
+
+We thank the Academic Editor and Reviewers for their valuable comments. We believe the revisions have substantially strengthened the protocol and satisfactorily addressed the comments raised by the Academic Editor and Reviewers. We are grateful for the constructive feedback and consideration of our revised submission.
+
+Attachment Submitted filename: Response to Reviewers.docx
+
+DOI: 10.1371/journal.pone.0352973.r003
+
+Decision Letter 1
+
+Badru Oluwaseun Academic Editor
+Badru Oluwaseun Academic Editor
+Copyright: © 2026 Oluwaseun Badru
+Copyright year: 2026
+Copyright holder: Oluwaseun Badru
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 1
+
+18 Jun 2026
+
+Integrating biomedical HIV prevention in schools: Protocol for a systematic review of interventions for Adolescent Girls and Young Women in Sub-Saharan Africa
+
+PONE-D-26-18433R1
+
+Dear Dr. Lodonu-Senoo,
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+DOI: 10.1371/journal.pone.0352973.r004
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+Acceptance letter
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+Badru Oluwaseun Academic Editor
+Badru Oluwaseun Academic Editor
+Copyright: © 2026 Oluwaseun Badru
+Copyright year: 2026
+Copyright holder: Oluwaseun Badru
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
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+PONE-D-26-18433R1
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+References
+
+1 UNAIDS. AIDS, crisis and the power to transform: UNAIDS Global AIDS Update 2025. Geneva. 2025 [cited 15 Dec 2025]. Available from: https://www.unaids.org/en/UNAIDS-global-AIDS-update-2025
+2 Mojola SA , Wamoyi J . Contextual drivers of HIV risk among young African women. 2019. doi: 10.1002/jia2.25302/full PMC6643074 31328409
+3 Mvundura M , Nundy N , Kilbourne-Brook M , Coffey PS . Estimating the hypothetical dual health impact and cost-effectiveness of the Woman’s Condom in selected sub-Saharan African countries. Int J Womens Health. 2015;7:271–7. doi: 10.2147/IJWH.S75040 25784820 PMC4356704
+4 Stover J , Teng Y . The impact of condom use on the HIV epidemic. Gates Open Res. 2022;5:91. doi: 10.12688/gatesopenres.13278.2 35355689 PMC8933340
+5 Aventin Á , Gordon S , Laurenzi C , Rabie S , Tomlinson M , Lohan M , et al. Adolescent condom use in Southern Africa: narrative systematic review and conceptual model of multilevel barriers and facilitators. BMC Public Health. 2021;21(1):1228. doi: 10.1186/s12889-021-11306-6 34172027 PMC8234649
+6 Ratnawati D , Huda MH , Mukminin MA , Widyatuti W , Setiawan A . Meta-analysis of the effectiveness of educational programs about HIV prevention on knowledge, attitude, and behavior among adolescents. Narra J. 2024;4(2):e870. doi: 10.52225/narra.v4i2.870 39280293 PMC11391990
+7 Niland R , Flinn C , Nearchou F . Assessing the role of school-based sex education in sexual health behaviours: a systematic review. Cogent Psychology. 2024;11(1). doi: 10.1080/23311908.2024.2309752
+8 Mason-Jones AJ , Sinclair D , Mathews C , Kagee A , Hillman A , Lombard C . School-based interventions for preventing HIV, sexually transmitted infections, and pregnancy in adolescents. Cochrane Database Syst Rev. 2016;11:CD006417. doi: 10.1002/14651858.CD006417.pub3 27824221 PMC5461872
+9 Mahomed S , Bukusi E , Sikazwe I , Musoke P , Karim QA . A risk- and needs-based strategy HIV prevention for adolescent girls and young women, WHO African Region. Bull World Health Organ. 2024;102(12):913–5. doi: 10.2471/BLT.23.291160 39611197 PMC11601182
+10 Nicol E , Basera W , Turawa E , Lombard C , Funani N , Chavhalala D , et al. Assessing PrEP initiation and adherence among high-risk, sexually active adolescents and young adults: a population-based prospective study across diverse service delivery models in a high HIV prevalent district in South Africa. AIDS Behav. 2025;29(8):2588–609. doi: 10.1007/s10461-025-04719-6 40312570 PMC12378780
+11 Maseko B , Hill LM , Phanga T , Bhushan N , Vansia D , Kamtsendero L , et al. Perceptions of and interest in HIV pre-exposure prophylaxis use among adolescent girls and young women in Lilongwe, Malawi. PLoS One. 2020;15. doi: 10.1371/journal.pone.0226062 PMC6957134 31929547
+12 Amaugo LG , Papadopoulos C , Ochieng BMN , Ali N . The effectiveness of HIV/AIDS school-based sexual health education programmes in Nigeria: a systematic review. Health Educ Res. 2014;29(4):633–48. doi: 10.1093/her/cyu002 24572458
+13 Denford S , Abraham C , Campbell R , Busse H . A comprehensive review of reviews of school-based interventions to improve sexual-health. Health Psychol Rev. 2017;11(1):33–52. doi: 10.1080/17437199.2016.1240625 27677440
+14 Shangase N , Kharsany ABM , Ntombela NP , Pettifor A , McKinnon LR . A systematic review of randomized controlled trials of school based interventions on sexual risk behaviors and sexually transmitted infections among young adolescents in sub-Saharan Africa. AIDS Behav. 2021;25. doi: 10.1007/s10461-021-03242-8 PMC8985547 33772695
+15 United Nations. Transforming our world: the 2023 agenda for sustainable development; 2015.
+16 WHO. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. 2015. Available from: https://apps.who.int/iris/bitstream/handle/10665/186275/9789241509565_eng.pdf;jsessionid=A279E21164BBA44795C8582F4A20ED25?sequence=1 26598776
+17 Proctor E , Silmere H , Raghavan R , Hovmand P , Aarons G , Bunger A , et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7 20957426 PMC3068522
diff --git a/corpus/healthcare/text/3090c49c00b7437f.txt b/corpus/healthcare/text/3090c49c00b7437f.txt
new file mode 100644
index 0000000000000000000000000000000000000000..45b39ce9d0a8fd51720e6f20443025fadd18f2f4
--- /dev/null
+++ b/corpus/healthcare/text/3090c49c00b7437f.txt
@@ -0,0 +1,69 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Res Involv Engagem
+Journal ID: Res Involv Engagem
+NLM Journal ID: 101708164
+
+Research Involvement and Engagement
+
+EISSN: 2056-7529
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13340379
+PMID: 42410662
+DOI: 10.1186/s40900-026-00936-y
+Article ID: 936
+Article version: 1
+Subjects: Correction
+
+Correction: Development of a 4Pi national involvement standards-based questionnaire to evaluate patient and public involvement
+
+Watson Kathryn 1
+Morton Richard 2
+Milenova Maria 1
+Chaplin Hema 1
+Letbe-Holder Erin 1
+Hackett Fiona 1
+Khoshaba Bernadette 1
+Chua Kia-Chong 3
+Russo Manuela manuela.russo@kcl.ac.uk
+1
+1 https://ror.org/0220mzb33 grid.13097.3c 0000 0001 2322 6764 Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
+2 https://ror.org/015803449 grid.37640.36 0000 0000 9439 0839 Improvement Service, South London and Maudsley NHS Foundation Trust, London, UK
+3 https://ror.org/0220mzb33 grid.13097.3c 0000 0001 2322 6764 Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK
+Electronic publication date: 2026 Jul 6
+Publication date: 2026
+Volume: 12
+Electronic Location ID: 109
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Development of a 4Pi national involvement standards-based questionnaire to evaluate patient and public involvement 12 19 2 2026 48 Research Involvement and Engagement 10.1186/s40900-026-00852-1 PMC13097933 41715201
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Correction to: Res Involv Engagem (2026) 12:48.
+
+10.1186/s40900-026-00852-1
+
+Following publication of the original article [1], the authors identified an error in the name of Hema Chaplin. The given name was incorrectly indicated.
+
+The incorrect author name is: H A. Chaplin.
+
+The correct author name is: Hema Chaplin.
+
+The author group has been updated above and the original article [1] has been corrected.
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+Reference
+
+1. Watson K, Morton R, Milenova M, et al. Development of a 4Pi national involvement standards-based questionnaire to evaluate patient and public involvement. Res Involv Engagem. 2026;12:48.10.1186/s40900-026-00852-1 PMC13097933 41715201
diff --git a/corpus/healthcare/text/3524923acce9bc18.txt b/corpus/healthcare/text/3524923acce9bc18.txt
new file mode 100644
index 0000000000000000000000000000000000000000..096e91d00e46e1b68d32c6f0dcb62e2f565590c7
--- /dev/null
+++ b/corpus/healthcare/text/3524923acce9bc18.txt
@@ -0,0 +1,370 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: JMIR Res Protoc
+Journal ID: JMIR Res Protoc
+NLM Journal ID: 101599504
+Journal ID: ResProt
+
+JMIR Research Protocols
+
+EISSN: 1929-0748
+Publisher: JMIR Publications Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13456303
+PMID: 42574675
+DOI: 10.2196/89576
+Article ID: 89576
+Article version: 1
+Subjects: Scoping Review Protocols, Behavior Change, Mental Health Issues in Adolescence, Parent and Caregiver Education and Behavior Change for Injury/Accident Prevention, Violence including Domestic Violence/Abuse, Nursing Education and Training, Novel and Innovative Approaches to Care Involving Nurses, Protocol
+
+Utilization of Training for Nurses in the Prevention of Adolescent Violence Risk Behaviors: Protocol for a Scoping Review
+
+https://orcid.org/0009-0008-3485-3737 Maryatun Sri SKep, Ns, MKep 1 2
+https://orcid.org/0000-0002-5406-8727 Nurjannah Intansari SKp, MNSc, PhD 3
+https://orcid.org/0000-0001-6439-2304 Pertiwi Ariani Arista Putri SKep, Ns, MAN, DNP 4 *
+1 Doctoral Program, Faculty of Medicine, Public Health and Nursing , Universitas Gadjah Mada , Palembang City , South of Sumatera , Indonesia
+2 Nursing Study Program , Faculty of Medicine, Universitas Sriwijaya , South of Sumatera , Indonesia
+3 Departement of Mental Health and Community Nursing , Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada , Yogyakarta , Indonesia
+4 Department of Basic and Emergency Nursing , Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada , Jl. Farmako, Sekip Utara Yogyakarta , 55281 , Indonesia , +6287878208878
+Schwartz Amy
+Ariani Arista Putri Pertiwi, SKep, Ns, MAN, DNP, Department of Basic and Emergency Nursing, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Jl. Farmako, Sekip UtaraYogyakarta, 55281, Indonesia, +6287878208878; ariani_psik@ugm.ac.id
+Publication date: 2026
+Electronic publication date: 2026 Aug 10
+Volume: 15
+Electronic Location ID: e89576
+Received 2025 Dec 14; Revised 2026 Jun 24; Accepted 2026 Jun 29
+Copyright: Copyright © Sri Maryatun, Intansari Nurjannah, Ariani Arista Putri Pertiwi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org)
+Copyright year: 2026
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: adolescent violence, aggressive behaviour, mental health, nurse education, prevention, scoping review
+
+Ÿ==============================Ÿ
+Abstract
+
+Background
+
+Adolescent violence is a significant public health issue that negatively affects the psychological well-being and social functioning of adolescents. These tendencies generally evolve from problems in anger management and stress tolerance related to inherent or external contributors including familial background, interactions with friends, and school atmosphere. Nurses, particularly in primary health care settings, are strategically positioned to contribute to violence prevention through early identification, intervention, and capacity-building programs for adolescents. However, evidence regarding the implementation of nurse-led violence prevention training, including its effectiveness, training approaches, and contextual influencing factors, remains limited.
+
+Objective
+
+This scoping review will map the nature, content, approach, and effectiveness of educational interventions developed for nurses to prevent violent behavior among adolescent learners in health services.
+
+Methods
+
+The protocol adheres to the Joanna Briggs Institute guidelines and the Arksey and O’Malley framework, including identifying the research question, searching for relevant studies, selecting eligible studies, charting the data, collating and summarizing the findings, and consulting experts. This review will be reported in accordance with the PRISMA extension for Scoping Reviews (PRISMA-ScR) guidelines. Literature searches will be conducted in PubMed, Scopus, ProQuest, and the Cochrane Library, along with gray literature sources including Google Scholar and GreyNet. Studies published in English that focus on educational or training interventions aimed at improving nurses’ capacity to prevent adolescent violence will be included, whereas studies unrelated to nurse-focused interventions or adolescent violence prevention will be excluded. Reviewers will independently conduct study selection and data extraction using a standardized extraction form. Extracted data will include study characteristics, intervention types, implementation strategies, outcomes, and contextual factors. The findings will be synthesized descriptively through narrative summaries and tabulated evidence mapping.
+
+Results
+
+Literature searches across the selected electronic databases were initiated in March 2025 using predefined search terms. Title and abstract screening, as well as preliminary appraisal of eligible studies, were conducted in May 2026 following the Joanna Briggs Institute methodology and PRISMA-ScR guidelines. Full-text screening, data extraction, and thematic analysis are currently ongoing and are expected to be completed by July 2026. The findings of this scoping review are expected to be submitted to a journal by September 2026.
+
+Conclusions
+
+This scoping review will provide a comprehensive evidence map of available training programs, implementation strategies, barriers to utilization, and their impact on nurses’ knowledge, attitudes, and skills related to adolescent violence risk behaviors. The findings are expected to support the scientific foundation for the development of the training model of the Prevention of Adolescent Violence-Risk Behavior (Keterampilan Pencegahan Risiko Perilaku Kekerasan Remaja [Kepolar]) in primary health care and inform policymaking to strengthen health professionals’ capacity in preventing adolescent violent behavior.
+
+Introduction
+
+Background
+
+Adolescence is a unique life stage, associated with extensive biological, cognitive, and social-emotional transitions [1]. Adolescents also begin to move from an egocentric mode of thought to a more abstract and introspective kind [2]. Unfortunately, immature cognitive development tends to make adolescents “thoughtless,“ “irritable,” and “reckless,” accompanied by increases in the risk of violent behaviors as well [1]. Emotional dysregulation and the obsessive quest for autonomy in a context of insufficient cognitive maturity render adolescents susceptible to inappropriate outbursts of anger [3,4].
+
+The World Health Organization defines violence as the intentional use of physical force or power that may result in injury, psychological harm, developmental disruption, or death [5]. Adolescent violent behavior may manifest in various forms, including physical aggression, verbal aggression, threatening behavior, bullying perpetration, fighting, emotional violence, and other externalizing behaviors [6,7]. These behaviors are associated with serious short- and long-term consequences, including physical injury, substance misuse, academic problems, criminal involvement, impaired social functioning, and mental health disorders [8,9]. Violence among adolescents also contributes substantially to the burden experienced by families, schools, health care systems, and communities [10].
+
+Recent evidence indicates increasing trends in peer aggression, physical violence, emotional violence, and other forms of externalizing behavior among adolescents worldwide [11]. A UNESCO (United Nations Educational, Scientific and Cultural Organization) report estimated that approximately one-third of adolescents aged 11‐15 years have experienced involvement in bullying or peer violence within school environments [12]. Over the past year, one-third of students (36%) aged 13‐15 years were involved in a physical fight with another student, and almost one in three (32%) had been physically attacked at least once [13]. A study in Indonesia, the National Survey on the Life Experiences of Children and Adolescents [14], found two in three children and adolescents have experienced violence at least once in their lives, with this figure increasing [15]. These findings highlight the urgent need for early identification, prevention, and intervention strategies targeting adolescents at risk of violent behavior, particularly within community and primary health care settings [16].
+
+Adolescent violent behavior is influenced by multiple interacting internal and external factors. Internal factors include age, sex, impulsivity, emotional regulation, psychological conditions, coping abilities, and spirituality [17,18]. External factors include parenting style, family conflict, peer influence, school climate, exposure to community violence, and broader social environments [19,20]. Conversely, protective factors such as family connectedness, empathy, religiosity, social support, and positive school engagement may reduce the likelihood of violent behavior [21,22]. Understanding these multidimensional influences is important for health care professionals, particularly nurses, in supporting early risk identification, prevention planning, and violence management among adolescents [23].
+
+Health care professionals, especially nurses working in primary health care and community settings, play an important role in preventing and managing adolescent violent behavior [24]. Nurses are often among the first health care providers to identify behavioral problems, aggression, emotional dysregulation, and psychosocial risks in adolescents [25]. Their roles may include early screening and risk assessment, psychoeducation, counseling, emotional regulation support, family involvement, crisis management, and referral coordination. Effective nursing interventions may contribute to reducing aggressive behavior and improving psychosocial and behavioral outcomes among adolescents [26].
+
+Despite the important role of nurses, previous studies indicate that many nurses report insufficient preparedness, limited confidence, and inadequate competencies in managing adolescents with violent or aggressive behavior [27-29]. Limited training in adolescent mental health, violence prevention, behavioral management, and psychosocial intervention may reduce nurses’ ability to provide early detection and appropriate interventions in health care settings [30]. In Indonesia, these challenges may be more pronounced because mental health services in primary health care settings (puskesmas) still predominantly focus on severe mental disorders rather than preventive interventions targeting adolescent behavioral risks [31].
+
+Recent studies suggest that education and training programs for health care professionals, including nurses, may improve confidence, preparedness, communication skills, risk assessment abilities, and management of violent or aggressive behaviors among adolescents [26]. Interactive approaches such as role-playing, simulation, case-based learning, and de-escalation training have been associated with improved competency development and more sustainable behavioral outcomes [32]. However, most violence prevention interventions have primarily focused on school-based or community-based youth programs, whereas evidence specifically examining nurse-targeted training for adolescent violence prevention and management remains limited [33]. Existing studies also commonly position nurses as facilitators or referral agents within broader community or school health initiatives rather than as primary targets of structured competency-based training programs [34].
+
+Implementation of violence prevention training programs is influenced not only by individual competencies but also by institutional and systemic support, including operational guidelines, referral pathways, leadership support, protected intervention time, and intersectoral collaboration [35]. Although adolescent violence may occur across school and community environments, this scoping review specifically focuses on nurse training interventions in the Prevention of Adolescent Violence Risk-Behavior (Keterampilan Pencegahan Risiko Perilaku Kekerasan Remaja [Kepolar]) program implemented within health care and primary health care contexts.
+
+Effective prevention and management of adolescent violent behavior require multidimensional approaches addressing individual, interpersonal, family, community, and societal factors, as described in the social ecological model [36,37]. Nursing interventions and training programs may also be informed by frameworks such as King’s Goal Attainment Theory [38] and Bronfenbrenner’s Ecological Systems Theory [39], which emphasize interactions among adolescents, health care providers, families, and surrounding environments. These theoretical perspectives may support the development of structured nurse training models for adolescent violence prevention within primary health care settings.
+
+Current evidence related to violence prevention interventions remains methodologically heterogeneous, with many studies characterized by small sample sizes, inconsistent outcome measures, and limited reporting transparency. Existing evidence on nurse training interventions for adolescent violence prevention has also not been comprehensively mapped regarding theoretical frameworks, intervention components, implementation strategies, and reported outcomes. Therefore, a scoping review is needed to systematically identify, map, and synthesize available evidence regarding nurse training interventions for adolescent violence prevention and management within primary health care settings.
+
+Objective
+
+This scoping review protocol seeks to offer a more structured and methodical approach for identifying young people who behave violently and ensuring they are referred to nurse education programs so that they may benefit from interventions provided therein. Our protocol is designed to make sure that the review procedure is carried out systematically and reproducibly, thereby reducing any possible bias and increasing methodological transparency as well as scientific trustworthiness.
+
+The purpose of this review is to create an evidence-based training model that can be used by nurses in primary health care centers (puskesmas) to prevent adolescent violent behavior. In particular, this scoping review aims to discern and map the current scientific evidence on training for nurses in adolescent violence prevention regarding theoretic frameworks, the main elements of interventions, and intervention delivery strategies and effects. Finally, risk and protective factors related to adolescent violent behavior will be discussed in this review, as well as the instruments adopted for measuring nurses’ knowledge, attitudes, skills, and self-efficacy. It will offer further evidence of training interventions’ impact on these competences.
+
+Methods
+
+This scoping review protocol follows the methodological guidance developed by Arksey and O’Malley [40], further refined by Levac et al [41], and aligns with the Joanna Briggs Institute methodology for scoping reviews. The review will also be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. A systematic and iterative review process will be undertaken to comprehensively map existing evidence regarding training and educational interventions for nurses in the prevention of adolescent violence risk behaviors.
+
+The review process will consist of six stages: (1) identifying the research questions; (2) developing eligibility criteria; (3) systematically identifying and selecting relevant studies; (4) charting and extracting data using a standardized extraction form; (5) collating, summarizing, and reporting the findings through descriptive narrative synthesis and evidence mapping; and (6) conducting expert consultation to strengthen the interpretation and applicability of the findings. We will conduct literature searches in PubMed, Scopus, ProQuest, and the Cochrane Library, as well as gray literature sources including Google Scholar and GreyNet. Two independent reviewers will perform study screening and data extraction, with disagreements resolved through discussion or consultation with a third reviewer when necessary.
+
+Protocol Registration and Reporting Information
+
+This protocol has been registered in the Open Science Framework. The final report will be prepared in accordance with the PRISMA-ScR checklist to ensure transparency and completeness throughout all stages of the review.
+
+Research Questions
+
+This scoping review seeks to map and synthesize the existing evidence regarding nurse training programs for the prevention of adolescent violent behavior in primary health care settings.
+
+The main research question guiding this review is “What evidence exists regarding training programs for nurses in the prevention of adolescent violent behavior in primary health care settings?”
+
+The review will further address the following subquestions:
+
+What risk and protective factors associated with adolescent violent behavior are reported in the literature?
+
+What types of training or educational programs for nurses related to adolescent violence prevention have been described?
+
+What theoretical frameworks, intervention components, and delivery strategies are used in these training programs?
+
+What instruments or assessment tools have been used to evaluate nurses’ knowledge, attitudes, skills, self-efficacy, or competencies related to adolescent violence prevention?
+
+What outcomes or reported impacts of nurse training programs related to adolescent violence prevention have been described in the literature?
+
+Eligibility Criteria
+
+The eligibility criteria for this scoping review were developed using the Population-Concept-Context (PCC) framework recommended by the Joanna Briggs Institute for scoping reviews (Table 1). The population of interest includes nurses and nursing personnel involved in providing care for adolescents who exhibit violent behavior. The concept focuses on violence prevention training interventions designed to enhance nurses’ capacity in managing adolescent violent behavior. These interventions may include educational programs, de-escalation training, communication skills training, simulation-based learning, and other strategies aimed at improving nurses’ knowledge, attitudes, competencies, confidence, preparedness, self-efficacy, and experiences in managing violent behavior among adolescents (Textbox 1). Comparators, where applicable, may include usual care, routine nursing practice without specific violence prevention training, health care services without active nurse involvement in violence prevention, or pre–post comparisons evaluating the effects of training interventions. The context of this review encompasses health care settings, community services, school-based health services, and primary health care facilities, including public health centers (puskesmas).
+
+Table 1. Population-Concept-Context framework.
+
+PCC	Description	
+Population	Nurses or nursing personnel involved in adolescent violence prevention and management	
+Concept	Training programs, educational interventions, simulation-based learning, de-escalation training, communication training, and competency development related to adolescent violence prevention	
+Context	Primary health care settings, community health care services, school health services, and other health care settings where nurses provide adolescent health services	
+
+Textbox 1. Inclusion and exclusion criteria.
+
+Inclusion criteria
+
+Studies involving nurses or nursing personnel in training or educational interventions related to adolescent violence prevention or management
+
+Studies conducted in health care, community, or school health settings
+
+Studies describing theoretical frameworks (eg, social ecological model, goal attainment theory, or other relevant models)
+
+Qualitative, quantitative, mixed methods studies, reviews, and relevant gray literature
+
+Publications in English or Indonesian
+
+Studies published between 2000 and 2024
+
+Exclusion criteria
+
+Studies focused exclusively on psychiatric disorder treatment without relevance to violence prevention or risk behavior management
+
+Studies without involvement of nurses or nursing personnel
+
+Editorials, opinion pieces, commentaries, and conference abstracts without full text
+
+Studies without accessible full text
+
+The review will consider qualitative, quantitative, and mixed methods studies, as well as review articles and relevant gray literature published in English or Indonesian between 2000 and 2024. Editorials, commentaries, opinion papers, conference abstracts without full text, and studies not related to violence prevention training for nurses in the context of adolescent violent behavior will be excluded. Studies eligible for inclusion are those that discuss violence prevention training, intervention programs, or related educational strategies for nurses in the context of adolescent violent behavior management. Editorials, commentaries, opinion papers, conference abstracts without full text, and studies not relevant to violence prevention training for nurses managing adolescent violent behavior will be excluded from the review.
+
+Population
+
+Although scoping reviews do not primarily aim to evaluate the effectiveness of interventions, the PCC framework was used to provide additional clarification regarding the focus of this review. The population of interest includes nurses or nursing personnel involved in adolescent violence prevention and management within primary health care, community health care, school-based services, or other health care settings.
+
+Intervention
+
+The included interventions of this scoping review are training and education initiatives that enhance nurses’ competencies regarding the prevention of violence in adolescents. These may include modules on emotional regulation, conflict resolution, early detection of violence risk, and communication strategies for managing adolescents. The training can be delivered through workshops, seminars, simulation-based learning, online courses, or blended methods. Some studies may also include the use of digital communication media as part of training delivery such as mobile apps, web-based platforms, social media, educational games, or interactive tools to support nurses in health promotion, emotional management, and psychosocial education for adolescents.
+
+Context
+
+The context of this review encompasses primary health care settings, community health care services, school health services, and other health care settings where nurses provide adolescent health services and are involved in violence prevention and management activities.
+
+Outcomes
+
+Because the objective of this scoping review is to map the breadth of existing evidence, outcomes will not be predefined as eligibility criteria. Instead, all reported outcomes associated with nurse training interventions for adolescent violence prevention will be charted during data extraction. These may include outcomes related to nurses (eg, knowledge, attitudes, competencies, confidence, and self-efficacy), adolescents (eg, behavioral and psychosocial outcomes), and implementation outcomes (eg, feasibility, acceptability, and sustainability).
+
+Identification of Relevant Studies
+
+A comprehensive literature search will be conducted to identify studies relevant to violence prevention training programs for nurses in the context of adolescent violent behavior management. Electronic databases to be searched include PubMed, Scopus, CINAHL, ProQuest, Web of Science, and ScienceDirect. Gray literature sources, including Google Scholar, institutional repositories, reports, and theses, will also be searched to identify additional relevant evidence. The search strategy is detailed in the next section.
+
+Search Strategy
+
+The search strategy will be developed in accordance with the objectives and research questions of this scoping review. Searches will be conducted using a combination of controlled vocabulary terms, including MeSH and free-text keywords related to nurses, violence prevention, adolescent violent behavior, and training or educational programs. Reference lists of included studies will also be screened manually to identify additional eligible articles.
+
+Keywords and phrases such as “violence prevention,” “aggression management,” “de-escalation training,” “nurse,” “nursing staff,” “adolescent,” “youth,” and “training program” will be combined using Boolean operators such as AND and OR. Quotation marks will be used for exact phrases where appropriate, and search strategies will be adapted according to the syntax and indexing systems of each database.
+
+Filters and limits applied during the search process will include publication years between 2000 and 2024, articles published in English or Indonesian, and studies available in full text when accessible. The search process and study selection procedure will be presented using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram.
+
+To ensure transparency and reproducibility, the complete PubMed search strategy for one electronic database is provided in Multimedia Appendix 1 and reported according to the PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Literature Search Extension) recommendations.
+
+Study Selection
+
+All retrieved records will be imported into EndNote (Clarivate; version 20) and subsequently uploaded into Rayyan (Rayyan Systems Inc; version 2024) for screening and duplicate removal. Two reviewers will independently screen titles and abstracts according to the eligibility criteria. Full-text articles of potentially relevant studies will then be assessed independently by the same reviewers. Disagreements at any stage will be resolved through discussion, and where consensus cannot be reached, a third reviewer will be consulted. The study selection process will be reported using a PRISMA-ScR flow diagram.
+
+Data Charting and Extraction
+
+A standardized data charting form will be developed to systematically extract and organize relevant information from the included studies. The form will be pilot-tested on a small number of studies and refined iteratively throughout the review process to ensure consistency and relevance to the review objectives and research questions.
+
+The extracted data will include author(s), year of publication, country of study, study design, study objectives, participant characteristics, health care or community setting, characteristics of the training or educational program, theoretical frameworks, delivery methods, duration of intervention, implementation strategies, measurement or assessment tools, and reported findings related to nurses’ competencies in adolescent violence prevention (Table 2). Information related to barriers, facilitators, implementation experiences, and recommendations for practice or future research will also be extracted where available.
+
+Table 2. Data extraction variables.
+
+Variable	Description	
+Study title	Full title of the article	
+Authors and year	Author(s) and year of publication	
+Country and context	Study setting, country, and health care/community context	
+Study design	Qualitative, quantitative, mixed methods, review	
+Population	Nurses or nursing personnel involved in adolescent violence prevention or care	
+Participant characteristics	Age group, professional role, sample size (if available)	
+Type of intervention	Description of training or educational intervention	
+Theoretical framework	Underlying theories or models (eg, social ecological model, goal attainment theory)	
+Training method	Mode of delivery (workshop, simulation, online, blended learning, etc)	
+Duration and frequency	Length and frequency of intervention	
+Implementation strategy	How the training was delivered and supported	
+Outcome measures	Nurses’ knowledge, attitudes, skills, self-efficacy, or other reported outcomes	
+Measurement tools	Instruments or scales used (if available)	
+Key findings	Main results as reported in the study	
+Barriers and facilitators	Factors influencing implementation or effectiveness	
+Study limitations	Limitations reported by authors	
+
+Data charting will be conducted independently by two reviewers using the standardized form. Any discrepancies in the extracted data will be resolved through discussion and consensus, with consultation from a third reviewer if necessary. The extracted data will be reviewed regularly to ensure accuracy, completeness, and alignment with the objectives of the scoping review.
+
+Data Synthesis
+
+Data will be summarized in narrative and tabular forms to map the extent, characteristics, and distribution of the existing evidence regarding violence prevention training programs for nurses in the context of adolescent violent behavior management. Consistent with the purpose of a scoping review, the synthesis will focus on describing and mapping available evidence rather than evaluating intervention effectiveness.
+
+Descriptive analysis (frequencies and percentages) will be conducted for quantitative data where appropriate, while qualitative findings will be synthesized using thematic analysis following the 6-phase approach proposed by Braun and Clarke [42]. The analysis will involve six iterative phases: (1) familiarization with the extracted data, (2) generation of initial codes, (3) searching for potential themes, (4) reviewing and refining themes, (5) defining and naming themes, and (6) producing the narrative synthesis. Themes will be developed inductively to map intervention characteristics, implementation strategies, barriers, facilitators, and reported outcomes related to nurse training for adolescent violence prevention. The synthesis process will also examine the characteristics of training programs, educational components, delivery methods, theoretical frameworks, assessment approaches, and reported findings related to nurses’ competencies in adolescent violence prevention.
+
+The findings will be presented in narrative summaries, evidence tables, and thematic groupings aligned with the objectives and research questions of the review. Quality appraisal will not be performed, as it is not mandatory for scoping reviews and the primary aim of this review is to comprehensively map the existing literature.
+
+Presentation and Reporting of Results
+
+Results will be presented according to the objectives and research questions of the review, including characteristics of training programs, educational components, delivery methods, theoretical frameworks, assessment approaches, implementation strategies, and reported findings related to nurses’ competencies in adolescent violence prevention. The synthesis will discuss the extent, nature, and limitations of the existing evidence and provide implications for nursing practice, policy, and future research.
+
+The study selection process will be presented using a PRISMA-ScR flow diagram, while the review findings will be summarized in narrative form and supported by evidence tables and thematic groupings where appropriate.
+
+Consultation Process
+
+Validity of the findings, missing evidence, and interpretation of results will be addressed through an expert consultation involving psychiatric nursing, adolescent psychology, and public health experts. Expert input will be included in the final synthesis to increase the relevance and utility of the review.
+
+Ethical Considerations
+
+As this is a review study, we use secondary data collected from previously published studies and therefore do not need any formal ethical approval. However, all procedures will be conducted in accordance with research ethics guidelines, such as following citation rules and acknowledging intellectual property rights. If the results are later to be used as the basis for a human study, ethical approval shall be sought before collecting data.
+
+Results
+
+Literature searches across the selected electronic databases were initiated in March 2025 using predefined search terms. Title and abstract screening, as well as preliminary appraisal of eligible studies, were conducted in May 2026 following the Joanna Briggs Institute methodology and PRISMA-ScR guidelines. Full-text screening, data extraction, and thematic analysis are currently ongoing and are expected to be completed by July 2026. The findings of this scoping review will be submitted to a journal by September 2026.
+
+This scoping review is expected to systematically map and synthesize the existing evidence regarding nurse training programs for the prevention of adolescent violent behavior in primary health care settings. The review findings will be organized in accordance with the objectives and research questions of the study, particularly focusing on the identification of risk and protective factors associated with adolescent violent behavior, the characteristics of nurse training and educational programs, and the theoretical frameworks underpinning these interventions. This scoping review is expected to provide a comprehensive map of existing evidence regarding nurse training interventions for adolescent violence prevention, including characteristics of interventions, theoretical foundations, implementation approaches, and reported outcomes. The findings will inform the development of the Kepolar model and support future nursing practice, policy, and research.
+
+The Kepolar model will subsequently be further developed and tested in the researcher’s (SM) doctoral dissertation. Moreover, the review is expected to contribute to practical and policy recommendations aimed at strengthening the promotive and preventive roles of nurses in puskesmas settings, thereby supporting adolescent mental health promotion and violence prevention efforts in Indonesia.
+
+Discussion
+
+This scoping review is expected to provide a comprehensive mapping of existing evidence regarding nurse training interventions for adolescent violence prevention and management within primary health care and community health care settings. This scoping review protocol concentrates on training targeting primary health care nurses to reduce the risk of violent behavior in adolescents, a direction that turns the focus from interventions exclusively aimed at adolescents toward equipping frontline health workers to be proactive regarding violence prevention. Early results from the international literature discuss that education and training for health care workers, including nurses, can improve confidence, readiness, communication skills, and practical competencies concerning risk assessment and management of violent situations (eg, de-escalation and referral screening) [43]. However, there remains relatively little direct evidence regarding the effectiveness of nurse-targeted training in reducing adolescent violence, with considerable heterogeneity in study designs, intervention characteristics, and outcome measures [26]. The review is also anticipated to demonstrate that evidence specifically focusing on structured nurse-targeted training for adolescent violence prevention remains limited compared with broader school-based or youth-focused violence prevention programs.
+
+Recent evidence underscores the critical role of multilevel interventions (eg, individual, family, school, health care system, and community levels) in accordance with the social ecological model [44]. Several assessed programs have primarily targeted adolescents through school-based life skills education, peer support interventions, and community psychosocial programs, demonstrating improvements in social competence, emotional regulation, knowledge, and risk-taking behaviors. Nevertheless, relatively few studies specifically examine nurse-targeted training, particularly within primary health care settings, where nurses may function as frontline screeners, facilitators, referral coordinators, and providers of psychosocial support. The present scoping review extends prior work by specifically focusing on nurse-targeted training interventions within health care and primary health care settings. This focus is particularly relevant in Indonesia and other low- and middle-income countries, where primary health care centers (puskesmas) often function as the first point of contact for adolescent health services and community mental health support.
+
+The literature indicates that training programs incorporating theoretical foundations (eg, trauma-informed care, ecological approaches, and life skills frameworks), ongoing supervision, and interactive learning modalities such as simulation, role-playing, communication exercises, de-escalation training, and case-based learning may result in greater competency acquisition and more sustainable behavioral change among health care providers [32]. In addition, multisession interventions with longer duration may provide more sustained effects compared with single-session workshops [45]. Accordingly, this review may help identify important intervention characteristics, including theoretical underpinnings, training content, delivery methods, implementation strategies, and duration of training programs.
+
+The findings of this review may also help clarify several important competencies and components that should be considered in nurse training programs for adolescent violence prevention and management. Core competencies may include early identification of violence risk factors, communication and therapeutic relationship skills, emotional regulation support, de-escalation techniques, behavioral assessment, trauma-informed care, crisis intervention, family engagement, referral coordination, and interprofessional collaboration. Existing literature also suggests that effective training programs often incorporate interactive and practice-based approaches such as simulation, role-playing, case discussions, and reflective learning activities rather than relying solely on didactic lectures [32,45,46].
+
+In addition, nurse training programs may require adaptation to local health care contexts, particularly within primary health care systems such as puskesmas in Indonesia, where nurses frequently manage adolescents with limited mental health resources and multidisciplinary support. Therefore, training programs may benefit from incorporating culturally appropriate approaches, practical referral algorithms, community-based case management strategies, and implementation guidance relevant to resource-limited settings. These findings may support the future development of more structured, competency-based, and contextually appropriate nurse training models for adolescent violence prevention.
+
+Institutional and systemic support including operational guidelines, referral pathways, leadership endorsement, protected implementation time, and intersectoral collaboration between health care services, schools, and child protection agencies have been identified as important determinants of training implementation and effectiveness [35,45]. Therefore, the focus on puskesmas in this protocol is considered particularly relevant because primary health care centers may function as coordination hubs connecting health care, educational, family, and community sectors in adolescent violence prevention efforts. However, in the absence of broader structural and organizational support, individual-level training alone may have limited impact. Accordingly, mapping studies that evaluate implementation-related constructs such as feasibility, acceptability, adherence, and sustainability may provide important insights for future intervention development and implementation.
+
+The majority of previous studies have evaluated training outcomes primarily at the provider level, including knowledge, attitudes, confidence, preparedness, and self-efficacy [32,47], while relatively fewer studies have assessed adolescent-level outcomes such as violent incidents, psychosocial functioning, school engagement, school attendance, or mental health indicators. Both provider-level and adolescent-level outcomes are considered within this protocol through the inclusion of studies evaluating nursing competencies as well as intervention impacts on adolescents. Importantly, improvements in nurses’ competencies alone may not necessarily reduce adolescent violence unless broader contextual issues including school culture, policy support, cross-sector partnerships, and health care infrastructure are also addressed [48]. The findings of this scoping review may therefore support policymakers and health care administrators in designing integrated adolescent violence prevention strategies that combine workforce development with broader system-level strengthening.
+
+Current systematic reviews and experimental studies focusing on violence prevention interventions remain methodologically heterogeneous, with many studies characterized by small sample sizes, inconsistent outcome measures, and limited reporting transparency. Among nurse training studies, many employ pre–post or qualitative evaluative designs, requiring cautious interpretation regarding intervention effectiveness. In addition, this review may identify considerable methodological heterogeneity across studies, including differences in study design, intervention components, measurement instruments, and reported outcomes [47]. As such, this scoping review represents an important initial step toward systematically identifying and synthesizing the nature, scope, and characteristics of current evidence before future large-scale intervention and implementation studies are conducted.
+
+Recent research has also explored innovative training modalities, including online learning platforms, blended learning approaches, digital educational modules, and virtual reality simulation training, to improve communication and de-escalation skills among health care workers [46]. Early evidence suggests that these approaches may increase engagement and facilitate skill acquisition, although long-term effectiveness and sustainability remain under investigation [46,48]. Future studies should also consider the use of standardized outcome measures to improve comparability across interventions. Further research is also needed to explore culturally appropriate and context-specific training models applicable to primary health care systems in Indonesia and other low- and middle-income countries.
+
+Several limitations identified in the international literature are also relevant to this protocol, including the limited availability of high-quality evidence specifically evaluating nurse training for adolescent violence prevention, substantial heterogeneity in terminology and outcome measures across studies, and contextual differences requiring adaptation of interventions to local health care systems and resource availability. This scoping review seeks to address some of these limitations through the inclusion of peer-reviewed literature, gray literature, qualitative studies, and instrument validation studies to provide a broader and more comprehensive evidence mapping.
+
+The findings of this scoping review will be disseminated through publication in peer-reviewed journals, presentations at national and international scientific conferences, and communication with health care stakeholders and policymakers. Dissemination activities may also include practical outputs such as stakeholder discussions, educational materials, implementation recommendations, policy briefs, and evidence-informed guidance to facilitate the translation of findings into nursing practice and adolescent mental health services. This scoping review protocol also has several strengths. It follows internationally recognized methodological frameworks, including the Joanna Briggs Institute methodology and Arksey and O’Malley framework, and includes both peer-reviewed and gray literature to support comprehensive evidence mapping. Another strength of this review is its focus on adolescent violence prevention within primary health care contexts, an area that remains relatively underexplored in existing literature. However, as a scoping review, this study will not formally assess the methodological quality or risk of bias of included studies. In addition, heterogeneity across study designs, intervention approaches, and outcome measures may limit comparability across studies.
+
+This scoping review protocol aims to systematically map and synthesize evidence regarding nurse training interventions for adolescent violence prevention and management within primary health care settings. Ultimately, this review may support future research, nursing practice, and policy development related to adolescent violence prevention within community and primary health care systems.
+
+Supplementary material
+
+10.2196/89576 Multimedia Appendix 1 Full PRISMA-S search strategies.
+
+10.2196/89576 Checklist 1 PRISMA-ScR checklist.
+
+Acknowledgments
+
+The authors would like to acknowledge the organizational support for this review from Gadjah Mada University and Sriwijaya University. We are also thankful for the financial assistance received from the Center for Higher Education Funding and the Indonesia Endowment Fund for Education, as acknowledged in decree 01637/J5.2.3./BPI.06/ 9/2022 (awardee ID202209091542). We also thank Dr Lutfan Lazuardi, the Director of Health Policy and Management in the Faculty of Medicine, Public Health, and Nursing at Universitas Gadjah Mada, Indonesia, for their suggestions in conducting this scoping review.
+
+Generative artificial intelligence tools were used solely to assist with language editing and improvement of manuscript readability. All intellectual content, interpretation of findings, methodological decisions, and final manuscript revisions were performed and verified by the authors, who take full responsibility for the content of this manuscript.
+
+Abbreviations
+
+Kepolar Keterampilan Pencegahan Risiko Perilaku Kekerasan Remaja (Prevention of Adolescent Violence-Risk Behavior)
+
+MeSH Medical Subject Headings
+
+PCC Population-Concept-Context
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+PRISMA-S Preferred Reporting Items for Systematic Reviews and Meta-Analyses Literature Search Extension
+
+PRISMA-ScR Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews
+
+UNESCO United Nations Educational, Scientific and Cultural Organization
+
+Funding: This study was supported by the Indonesian Educator Scholarship Program (Beasiswa Pendidikan Indonesia [BPI]) administered by the Center for Higher Education Funding and the Indonesia Endowment Fund for Education (LPDP), award number 01637/J5.2.3./ BPI.06/9/2022. The funding body had no role in the design, conduct, writing, or decision to publish this protocol.
+
+Authors’ Contributions: SM designed and wrote the manuscript. IN provided advice and reviewed the manuscript. AAPP helped write and proofread the manuscript and will review the screening process selection on Rayyan. All authors read and approved the final manuscript.
+
+Data Availability: No primary datasets were generated or analyzed during this protocol study. The search strategies, extraction forms, and materials developed for the review will be made available as supplementary materials and through the Open Science Framework repository upon completion of the review. Any additional materials may be made available from the corresponding author upon reasonable request.
+
+Conflicts of Interest: None declared.
+
+
+References
+
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+30. Hoffmann U Clemens V König E Brähler E Fegert JM Violence against children and adolescents by nursing staff: prevalence rates and implications for practice Child Adolesc Psychiatry Ment Health Nov 6 2020 14 1 43 doi 10.1186/s13034-020-00350-6 Medline 33292414 PMC7648387
+31. Sahriana NIM Peran kader kesehatan jiwa dalam program kesehatan jiwa komunitas di masyarakat [Dissertation in Indonesian] Surabaya Universitas Airlangga 2018 URL https://repository.unair.ac.id/78476/2/TKP%2095_18%20Sah%20p.pdf Accessed 25-10-2025
+32. Dafny HA Waheed N Cabilan CJ et al Effectiveness of interventions for the prevention or management of workplace violence in student nurses during clinical placement: a systematic review J Adv Nurs Mar 2025 81 3 1142 1171 doi 10.1111/jan.16357 Medline 39078141 PMC11810489
+33. Eldred E Devries K Nelson KA et al A systematic review and equity analysis of school-based violence prevention interventions evaluated in randomised controlled trials BMC Public Health 01 28 2026 26 1 681 doi 10.1186/s12889-025-26142-1 Medline 41593599 PMC12922353
+34. Agatha EZ Yosep I Hernawaty T et al Beyond the trauma: a scoping review of nursing interventions for improving psychological well-being in adolescents bullying victims BMC Nurs 07 25 2025 24 1 973 doi 10.1186/s12912-025-03642-4 Medline 40713664 PMC12297714
+35. Vijh R Exner-Cortens D Madigan S Noel M Adolescent dating violence prevention in healthcare settings: systematic scoping review Trauma Violence Abuse Oct 29 2025 15248380251381811 doi 10.1177/15248380251381811 Medline 41163319
+36. Supartini Y Tambunan ES Suheri T Ningsih R Pengembangan Model Deteksi Dini Kekerasan Pada Remaja Sebagai Upaya Meningkatkan Kemampuan Dalam Mendeteksi Adanya Kekerasan Pada Remaja [Article in Indonesian] QJK 2022 16 2 82 95 doi 10.36082/qjk.v16i2.792
+37. Global status report on violence prevention 2014 World Health Organization 2014 URL https://www.undp.org/sites/g/files/zskgke326/files/publications/UNDP-GVA-violence-2014.pdf Accessed 29-07-2026
+38. King IM King’s theory of goal attainment Nurs Sci Q 1992 5 1 19 26 doi 10.1177/089431849200500107 Medline 1538850
+39. Bronfenbrenner U Morris PA The ecology of developmental processes Damon W Lerner RM Handbook of Child Psychology: Theoretical Models of Human Development 5th John Wiley & Sons 1998 993 1028 ISBN 9780470147658
+40. Arksey H O’Malley L Scoping studies: towards a methodological framework Int J Soc Res Methodol Feb 2005 8 1 19 32 doi 10.1080/1364557032000119616
+41. Levac D Colquhoun H O’Brien KK Scoping studies: advancing the methodology Implement Sci Sep 20 2010 5 69 doi 10.1186/1748-5908-5-69 Medline 20854677 PMC2954944
+42. Braun V Clarke V Using thematic analysis in psychology Qual Res Psychol 01 2006 3 2 77 101 doi 10.1191/1478088706qp063oa
+43. Brenig D Gade P Voellm B Is mental health staff training in de-escalation techniques effective in reducing violent incidents in forensic psychiatric settings? - A systematic review of the literature BMC Psychiatry Apr 12 2023 23 1 246 doi 10.1186/s12888-023-04714-y Medline 37046228 PMC10099889
+44. Steeger CM Combs KM Buckley PR et al Substance use prevention during adolescence: study protocol for a large-scale cluster randomized trial of Botvin High School LifeSkills Training Contemp Clin Trials Feb 2023 125 107049 doi 10.1016/j.cct.2022.107049 Medline 36521631
+45. Jackson DI Maa T Luna J Huang Y Fristad MA Sezgin E Challenges and opportunities in healthcare workplace violence training: a qualitative study of staff experiences J Workplace Behav Health Oct 2 2025 40 4 641 654 doi 10.1080/15555240.2025.2474055
+46. Peddle M Jackson M Searby A Alexander L Influence of simulation on the knowledge, skills, and confidence of entry-to-practice nursing students to recognise and respond to occupational violence and aggression: A scoping review Nurse Educ Today Mar 2026 158 106939 doi 10.1016/j.nedt.2025.106939 Medline 41319445
+47. Somani R Muntaner C Hillan E Velonis AJ Smith P A systematic review: effectiveness of interventions to de-escalate workplace violence against nurses in healthcare settings Saf Health Work Sep 2021 12 3 289 295 doi 10.1016/j.shaw.2021.04.004 Medline 34527388 PMC8430427
+48. Clay CJ Hochmuth JM Wirth O Virtual reality training to reduce workplace violence in healthcare Issues Ment Health Nurs 01 2025 46 1 2 11 doi 10.1080/01612840.2024.2429712 Medline 39761223 PMC11774209
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Epilepsia
+Journal ID: Epilepsia
+NLM Journal ID: 2983306R
+Journal ID: EPI
+
+Epilepsia
+
+ISSN: 0013-9580
+EISSN: 1528-1167
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12661290
+PMID: 40768372
+DOI: 10.1111/epi.18570
+Article ID: EPI18570
+Article ID: EPI-00337-2025.R2
+Article version: 1
+Subjects: Critical Review, Critical Review
+
+What matters most to people living with epilepsy? A rapid review of qualitative research relating to health outcomes
+
+Mitchell et al.
+
+Mitchell James W. https://orcid.org/0000-0002-6465-0382 1 2 james.mitchell@liverpool.ac.uk
+
+Doherty John 2
+Batchelor Rachel 3
+Noble Adam https://orcid.org/0000-0002-8070-4352 4
+Marson Anthony 1
+1 Institute of Systems, Molecular, and Integrative Biology University of Liverpool The Clinical Sciences Centre, Aintree Hospital Site, Lower Lane Liverpool L9 7AL UK
+2 Department of Neurology Walton Centre NHS Foundation Trust Liverpool UK
+3 Oxford Institute of Clinical Psychology Training and Research University of Oxford Oxford UK
+4 Department of Public Health, Policy, and Systems, Institute of Population Health, Policy, and Systems University of Liverpool Liverpool UK
+* Correspondence
+James W. Mitchell, Institute of Systems, Molecular, and Integrative Biology (ISMIB), University of Liverpool, The Clinical Sciences Centre, Aintree Hospital Site, Lower Lane, Liverpool L9 7AL, UK.
+Email: james.mitchell@liverpool.ac.uk
+
+Electronic publication date: 2025 Aug 6
+Print publication date: 2025 Nov
+Volume: 66
+Issue: 11
+First page: 4122
+Last page: 4138
+Revised 2025 Jul 5; Received 2025 Mar 11; Accepted 2025 Jul 5
+Copyright: © 2025 The Author(s). Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: adult epilepsy, focus groups, health outcomes, in‐depth interviews, qualitative review
+
+Funding: Association of British Neurologists Clinical Research Training Fellowship Guarantors of Brain 10.13039/501100000627
+Figure count: 2
+Table count: 2
+Page count: 17
+
+source-schema-version-number: 2.0
+cover-date: November 2025
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.6.6 mode:remove_FC converted:28.11.2025
+
+Mitchell JW , Doherty J , Batchelor R , Noble A , Marson A . What matters most to people living with epilepsy? A rapid review of qualitative research relating to health outcomes. Epilepsia. 2025;66:4122–4138. 10.1111/epi.18570 PMC12661290 40768372
+
+Ÿ==============================Ÿ
+Abstract
+
+At present, the outcomes measured and reported in clinical trials for adults with epilepsy are heterogenous and have often not been selected in consultation with people living with epilepsy. As part of a wider project developing a core outcome set for clinical trials for adults with epilepsy (the EPSET Project), a rapid review of the published qualitative literature was performed. MEDLINE was searched using an established qualitative methodological search filter to identify studies discussing the views of adults with epilepsy and their representatives. Eligible articles included published free‐text verbatim quotations from adults with epilepsy or their representatives discussing potential health outcomes. Data were coded and categorized in line with an established health outcome taxonomy. A total of 614 eligible articles were identified, of which 74 were included as they met the inclusion criteria. In total, the views of more than 2474 adults with epilepsy and 658 caregivers were included from six continents. Of the included studies, 77% used in‐depth interviews and 12% used focus groups. A total of 140 individual health outcomes were identified in the included studies across nine outcome domains: seizure‐related, cognitive–behavioral–neuropsychological, physical functioning–disability, emotional functioning, social role functioning, global quality of life, side effects and adverse events, fertility–pregnancy–offspring, and death. This is the first review of qualitative studies focusing on health outcomes for adults with epilepsy. The findings confirm that living with epilepsy represents more than living with seizures and highlight the impact of neuropsychiatric symptoms in these populations. Importantly, many outcomes identified from this review are not measured and reported in studies assessing the effectiveness and safety of treatments for epilepsy, supporting the development of a lived experience‐informed core outcome set for future effectiveness studies. Furthermore, the findings could be used to inform clinical practice and noninterventional studies across broad geographic, societal, and cultural settings.
+
+Key points
+
+A synthesis of published qualitative literature was undertaken, representing the views of more than 3100 people with epilepsy and caregivers.
+
+Data about outcomes were extracted, with 140 outcomes identified across nine domains.
+
+Outcomes in the social and role functioning and "emotional functioning" domains were most frequently reported.
+
+The results should have wide‐reaching implications, providing new insights on what matters most to people with epilepsy.
+
+1 INTRODUCTION
+
+Randomized controlled trials are the gold standard source of evidence about the effectiveness and safety of treatments, informing guidelines and treatment decisions for people with epilepsy (PWE). Alongside continued drug development, there is a need for refining clinical trial design to ensure that the methods and results meet the needs of PWE taking part in trials, the wider epilepsy community, and regulatory agencies. There has, for instance, been much debate about reducing placebo exposure on ethical grounds, improving the external validity of regulatory studies, and ensuring trials are performed for some of the neglected rarer epilepsy syndromes. 1 , 2 , 3 , 4 Furthermore, and of particular pertinence to the current article, is discussion about the choice of "outcomes" or "endpoints" used in trials assessing the effectiveness and safety of interventions for PWE, particularly given the inconsistency of outcome reporting identified by Cochrane reviews and meta‐analyses. 5
+
+For other long‐term health conditions, there is an increasing international effort to identify core outcome sets (COSs), to obtain consensus on which outcomes should be reported as a minimum in research or routine clinical practice. 6 , 7 , 8 , 9 COSs for research facilitate interventional studies that are relevant to patients and health services and help standardize clinical trial methodology. They allow for research that is representative of international perspectives, and standardization of outcome measurement enables more meaningful results to be obtained from systematic reviews and meta‐analyses. 10
+
+Several consensus exercises have been conducted developing COSs for use in epilepsy populations. These include the COSs for routine practice clinic settings for infants, children, adolescents, and adults with epilepsy by the International Consortium for Health Outcomes Measurement, 11 , 12 for research assessing the effectiveness of interventions specifically for children with Rolandic epilepsy, 13 and for quality‐of‐life outcomes for adults with drug‐resistant epilepsy in English‐speaking settings. 14 At present, there is no internationally agreed COS for adult epilepsy interventional studies assessing treatment effectiveness. A COS for adult epilepsy effectiveness studies could help address some of the methodological difficulties in epilepsy clinical trial design by defining the minimum set of outcomes to be measured in relevant future research for adults with epilepsy.
+
+The first step in COS development typically involves a review of existing knowledge to inform the consensus process. When developing a COS, it is important to include the patient experience, views of researchers and clinicians, and existing practice to inform the list of outcomes that are used to obtain consensus on which outcomes are essential to measure. 8 Evidence from comparative studies assessing the use of qualitative methods in outcome set development indicates that including patient and caregiver perspectives leads to the identification of additional outcomes beyond those identified by health professionals alone, ensuring that the final COS is representative of a wider range of stakeholders. 15 , 16 Qualitative research exploring the lived experience perspective on what matters most about living with a health condition should therefore inform COS development, in particular by facilitating development of the "long list" of potential outcomes that develop in the information‐gathering phase of the process.
+
+The epistemological and methodological theories underpinning qualitative research often highlight the importance of extensive interaction with research participants, giving weight to the meanings that people attach to their experiences and prioritizing depth of understanding over breadth of coverage. 17 Therefore, qualitative research is well placed to improve understanding of patient perspectives on outcomes, as these studies allow people to express their views in an open‐ended manner representative of their lived experience, with the inductive approach to enquiry allowing for novel insights to be ascertained.
+
+Primary qualitative research can be extremely resource‐intensive, particularly when considering training of a study team in qualitative research theories and methodology, undertaking patient interviews, transcribing the audio, and interpreting the data. Given that there is already a substantial body of qualitative literature published within the field of epilepsy, a systematic review of published qualitative studies was performed, rather than generating primary data by undertaking interviews or focus groups with people with lived experience. This alternative to conducting primary qualitative research, where suitable published studies are available, has been adopted by previous COS developers in the fields of diabetes mellitus, critical illness, bariatric and metabolic surgery, neonatal care, and tuberculosis. 18 , 19 , 20 , 21 , 22 These reviews have all identified outcomes not reported in systematic reviews of clinical trials, further supporting the notion that qualitative evidence is needed to ensure that the outcome "long list" is comprehensive and does not omit outcomes deemed important to those with lived experience.
+
+Here, we report the results of a rapid review, synthesizing the outcomes reported by adults with epilepsy when asked about their lived experience. This work was undertaken as part of a larger study developing a COS for effectiveness studies for adults with epilepsy, the EPSET project (www.epsetproject.org). 23 Combining the results of this study with the results of a systematic review of outcomes reported in clinical trials will create a long list of outcomes 24 to be used as the starting point for the consensus process to define the COS. The results should also have wider reaching implications, by providing new insights on what matters most to people living with epilepsy in a diverse range of geographic, societal, and cultural settings, which could additionally be used to influence clinical practice and noninterventional studies.
+
+Please see online Supporting Information Appendix S1 for a schematic overview of the EPSET COS development process.
+
+1.1 Review aims
+
+This review aimed to: Identify outcomes important to adults with epilepsy from the published qualitative literature.
+
+Allow for the lived experience perspective to be incorporated into the initial stages of developing a COS for interventional studies for adults with epilepsy, by developing a "long list" using multistakeholder coproduction.
+
+2 MATERIALS AND METHODS
+
+2.1 Study identification
+
+Rapid review methodology was used to synthesize evidence within a shortened time frame. 25 This method uses an accelerated form of the traditional systematic review process and can provide an overview of evidence across a broad research area without providing exhaustive coverage of all published primary research.
+
+We searched the single health‐related database, MEDLINE, with no date restrictions, on September 1, 2021. The search terms used are indicated in Table 1 and comprise qualitative methodological filters previously shown to identify qualitative research with high sensitivity and precision. 26
+
+TABLE 1 MEDLINE search strategy for qualitative review.
+
+	((semi‐structured or semistructured or unstructured or informal or in‐depth or indepth or face‐to‐face or structured or guide) adj3 (interview* or discussion* or questionnaire*))	Title or abstract	
+OR (focus group* or qualitative or ethnograph* or fieldwork or field work" or key informant)	MeSH terms	
+OR interviews as topic/ or focus groups/ or narration/ or qualitative research/	
+AND	Epilep*	Title or abstract	
+AND	symptom* OR treatment* OR living with OR experience*	Title or abstract	
+AND	patient* OR people with OR person with	Title or abstract	
+Abbreviation: MeSH, Medical Subject Headings.
+
+Studies reporting qualitative primary evidence of the views and experiences of adults with epilepsy living with their condition and its treatment were eligible for inclusion. Studies focusing on infants, children, and adolescents with epilepsy and people with acute symptomatic seizures were outside of the scope of this review, as the intention was to inform the development of a COS for adults with epilepsy.
+
+2.2 Study selection
+
+J.W.M. and J.D. independently screened identified article abstracts, with any disagreements with study selection resolved through discussion with independent coresearcher Guleed Adan as an arbitrator. Full‐text articles were retrieved by J.W.M. and reviewed for studies meeting the following inclusion and exclusion criteria:
+
+Inclusion criteria Person with epilepsy was age ≥18 years at time of data collection.
+
+Study focus was epilepsy and not the causative comorbidity (e.g., underling tumor or previous stroke).
+
+Qualitative methods were used as the primary source of data acquisition.
+
+Exclusion criteria Review articles with no presentation of original verbatim quotes from people with epilepsy or their representatives.
+
+2.3 Data extraction
+
+For each included study, the following were extracted: Year of publication.
+
+Authors.
+
+Study title.
+
+Participant data: number in study, age, sex, epilepsy characteristics.
+
+Geographical location of study participants.
+
+Qualitative data collection and analysis methods used.
+
+Verbatim excerpts relevant to outcomes.
+
+Text, including participants' quotations, extracted verbatim from both the results and discussion section of the relevant papers. These data are available in Appendix S3 in the online Supporting Information.
+
+2.4 Data categorization
+
+A content analysis approach was used to synthesize data from the eligible studies. Outcomes were coded and analyzed using NVIVO software, and from the outcome codes produced we initially used the Core Outcome Measurement in Effectiveness Trials (COMET) taxonomy to categorize the verbatim text from the studies. Once granular terms were grouped within the COMET taxonomy; further categorization was performed iteratively, with development of new summary terms for outcomes that did not fit within the existing COMET taxonomy and to ensure an adequate level of granularity was maintained for seizure‐related outcomes. Where possible, terminology close to the language used within original verbatim text was used to describe the outcomes, and it was anticipated that these summary terms would be suitable to take forward to a multistakeholder consensus process to define a COS for treatment effectiveness studies for adults with epilepsy. Risk of bias and quality appraisals for individual studies were not performed, as it was anticipated that a broad range of qualitative research methodologies would be used in the included studies, and quality assessment in qualitative research remains controversial. 27
+
+2.5 Review registration
+
+This review was registered on the PROSPERO database prior to commencement (CRD42020215156). 28
+
+3 RESULTS
+
+3.1 Study characteristics
+
+The search returned 614 articles. Of these, 193 were retained after screening titles and abstracts. Following full‐text review, 119 studies were excluded, as they did not meet the inclusion criteria or presented duplicate data. The study selection process is outlined in (Figure 1).
+
+FIGURE 1 Study identification flow diagram for review of outcomes from qualitative literature.
+
+In total, the views of more than 2474 adults with epilepsy and 658 caregivers or significant others were included (median = 20 adults with epilepsy, range = 4–632) from six continents. The geographical distribution of participants in the included studies is outlined in Figure 2.
+
+FIGURE 2 Geographical location of adults with epilepsy in included qualitative studies. Dark red shading represents country of residence of study participants from included studies. Map generated using mapchart.net.
+
+All studies included PWE, with one study also involving another illness group (multiple sclerosis) 29 and many including views of health care professionals and caregivers. A range of research enquiries were covered in the included studies, with many examining the impact of living with epilepsy broadly within a particular geographical, cultural, or population context. 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 Others explored the lived experience perspective in more specific settings, such as the experience of visiting an emergency department due to seizures and their consequences, 47 developing complex educational and behavioral interventions for assessment in randomized controlled trials, 48 , 49 as part of a nested study within a randomized controlled trial to provide an in‐depth exploration of the views about a treatment intervention, 50 or in the item generation phase of health outcome measurement instrument development. 51 Many studies examined specific aspects of living with epilepsy in society, such as stigma and discrimination, 51 , 52 , 53 , 54 , 55 self‐management, 56 and acceptance of the diagnosis. 57
+
+Most studies included people with a wide range of epilepsy classifications, using purposive sampling to ensure that views represented a broad range of PWE. Some studies specifically included people with newly diagnosed epilepsy 58 , 59 , 60 ; others included only those with treatment‐refractory epilepsy. 31 , 34 , 49 , 50 , 61 Some exclusively recruited people with epilepsy and intellectual or learning disability, 35 , 62 some only included people with focal onset epilepsy, 34 , 54 , 56 , 63 and others exclusively included people with generalized or genetic epilepsy syndromes. 64 , 65 Some studies also explored aspects of living with specific epilepsy syndromes such as tuberous sclerosis complex syndrome. 37
+
+It was not possible to provide an aggregated summary of participant demographic and clinical characteristics, given that these were not provided for some of the studies. In 14 of the included studies, no information regarding the classification, duration, or severity of epilepsy of its participants was provided in the article. Where demographic data were provided, it was often summarized as categorical rather than continuous variables, with different categories used in different studies, or only summary statistics reported.
+
+A summary of included studies is provided in Appendix S2 in the online Supporting Information.
+
+Of the included studies, 77% used in‐depth interviews as their primary data collection method, 12% used focus groups, 4% used focus groups and supplementary in‐depth interviews, and 7% used mixed methods approaches typically combining quantitative surveys with analysis of free‐text data from open‐ended questions. A range of epistemological and methodological approaches were described, including grounded theory, ethnography, phenomenology, narrative research, and mixed methods research. Where multiple stakeholders were involved in a study representing many conditions or disease processes, only data pertaining to PWE or their caregivers in their own voice were extracted, to ensure the views presented are as representative as possible of the views of the lived experience, without researcher or clinician interpretation.
+
+Analysis of outcomes had been planned to continue across consecutive retrospective studies until five consecutive articles demonstrated outcome saturation, that is, no new outcomes identified. Outcome extraction saturation was never reached, meaning that data from all 74 included studies were used for the outcome synthesis.
+
+3.2 Data categorization
+
+A total of 140 individual outcomes were identified from the included studies and categorized according to the summary outcome framework that was informed by the COMET taxonomy, and the Wilson and Cleary conceptual model of health‐related quality of life, which integrates symptom status, functional state, general health perceptions, and the psychosocial aspects of health status. 66 , 67 The framework of domains and outcomes is outlined in Table 2. A table of all outcomes with supporting verbatim quotes from all of the included studies is available in Appendix S3 in the online Supporting Information.
+
+TABLE 2 Domains and outcomes identified from verbatim quotations from participants in studies.
+
+Domain	Outcome	Number of references	
+Seizure outcomes	Seizure freedom	15	
+Seizure‐related injury	13	
+Seizure frequency	10	
+Experience of seizures (general)	10	
+Experience of auras	5	
+Focal onset seizures without generalization	4	
+Seizure with impaired awareness, including generalized tonic–clonic seizures	4	
+Postictal drowsiness	4	
+Seizure duration	4	
+Difficulty with breathing during seizure	3	
+Loss of motor control during seizures	3	
+Postictal symptoms—other	3	
+Ability to identify seizure triggers	2	
+Duration of postictal recovery	2	
+Experience of myoclonic jerks/myoclonic seizure	2	
+Seizure‐related loss of awareness	2	
+Seizure severity	2	
+Status epilepticus/prolonged seizures requiring rescue medication	2	
+Unpredictability of seizures	2	
+Other outcomes only identified in one study
+
+Brain injury following prolonged seizures
+
+Cognitive symptoms during seizures
+
+Emotional distress during/following seizure
+
+Experience of sensory phenomena during seizure
+
+Motor symptoms of seizure
+
+Only focal seizures (without generalization/impaired awareness)
+
+Seizure‐related amnesia
+
+		
+Cognitive, behavioral, and mental health outcomes	Symptoms of depression	11	
+Poor memory or concentration	11	
+Anxiety—general	8	
+Knowledge about epilepsy (satisfaction)	8	
+Suicidality	5	
+Anxiety symptoms from seizure‐related uncertainty	4	
+Sense of hopelessness	4	
+Other outcomes only identified in one study
+
+Safety consequences due to poor memory
+
+Word‐finding difficulty
+
+Impact of poor memory on medication compliance
+
+		
+Sleep and related outcomes	Adequate sleep quality and duration	1	
+Physical functioning, participation, and disability	Independence (or loss of independence)	7	
+Ability to go swimming	5	
+Ability to exercise	4	
+Sexuality and sexual functioning	4	
+	
+Ability to do gardening	2	
+Ability to exercise alone	2	
+Other outcomes only identified in one study
+
+Ability to go shopping
+
+Ability to partake in team sports
+
+Ability to go do dance
+
+Ability to ride bicycle
+
+Ability to go hiking/mountaineering
+
+		
+Emotional functioning	Perceived stigma or discrimination	32	
+Ability to disclose diagnosis to others	13	
+Acceptance of epilepsy	27	
+Fear of seizures—seizure‐related worry	9	
+Fear of seizure‐related injury	8	
+Perception of being in control	8	
+Sense of embarrassment	8	
+Sense of normality	8	
+Sense of isolation	7	
+Perception of lack of control	6	
+Self‐confidence	5	
+Sense of being defined by epilepsy	5	
+Self‐efficacy (regarding uncertainty of seizures)	4	
+Self‐resilience or self‐efficacy (general)	4	
+Fear of medication side effects	3	
+Low self‐esteem	3	
+Impact of epilepsy on sense of self	3	
+Sense of not being defined by epilepsy	3	
+Fear of SUDEP	2	
+Other outcomes only identified in one study
+
+Positive sense of self
+
+Absence of seizure‐related worry
+
+Acceptance of SUDEP risk
+
+Fear of seizure while swimming
+
+Feeling of vulnerability
+
+Irritability
+
+Negative sense of self
+
+Anger or frustration with seizures
+
+Sense of being helpless
+
+		
+Social and role functioning	Work status	25	
+Driving	20	
+Impact on relationships and friendships	17	
+Impact on education and schooling	13	
+Ability to socialize	12	
+Ability to form companionship or get married	11	
+Ability to fulfill parental role	9	
+Ability to fulfill work role	9	
+	
+Psychosocial burden on others	9	
+Sense of social exclusion or alienation	8	
+Ability to leave the house	7	
+Dependence on others	7	
+Ability to have children	6	
+Change in social behaviors due to seizures	5	
+Burden from not driving	4	
+Acceptance by others (no stigma)	4	
+Exclusion by family	3	
+Ability to develop a career/profession	3	
+Sense of belonging (others have epilepsy too)	3	
+Ability to go on holiday	2	
+Impact on gender identify	2	
+Ability to make new friends	2	
+Burden on caregivers	2	
+Burden on friends and family	2	
+Other outcomes only identified in one study
+
+Inability to drink alcohol socially
+
+Career progression
+
+Involvement with law enforcement agency due to seizure‐related behavior
+
+		
+Life impact outcomes, including global quality of life	Financial impact of medication	7	
+Financial security	6	
+Financial impact of not working	5	
+HRQOL not otherwise specified	3	
+Other outcome only identified in one study
+
+Financial impact of hospital attendance
+
+		
+Health resource use	Need for hospital or emergency department attendance	8	
+Unnecessary hospital attendance	2	
+Other outcome only identified in one study
+
+Need for emergency ambulance
+
+		
+Side effect outcomes and drug monitoring	Medication side effect (general)	10	
+Medication‐related somnolence	9	
+Medication‐related weight gain	7	
+Medication‐related mood changes	5	
+Medication‐related cognitive disturbance	5	
+Medication‐related fatigue	4	
+Impact of medications on offspring health	4	
+Medication‐related weight loss	3	
+Medication‐related irritability	3	
+	Other outcomes only identified in one study
+
+Medication‐related aggression and impulsivity
+
+Medication‐related excess sweating
+
+Medication interactions
+
+Medication‐related anxiety
+
+Medication‐related osteopenia/osteoporosis
+
+Medication‐related dizziness
+
+Medication‐related alopecia
+
+Medication‐related appetite change
+
+Medication‐related headaches
+
+Medication‐related nausea
+
+Medication‐related personality change
+
+Paradoxical medication‐related seizures
+
+Medication‐related sleep disturbance
+
+Medication‐related vomiting
+
+		
+Pregnancy and offspring outcomes	Ability to get pregnant	3	
+Impact of seizure on fetal health and child development (including congenital malformations)	2	
+Unintended pregnancy	2	
+Other outcome only identified in one study
+
+Ability to breastfeed
+
+		
+Death	Mortality	4	
+SUDEP	2	
+Abbreviations: HRQOL, health‐related quality of life; SUDEP, sudden unexpected death in epilepsy.
+
+3.3 Seizures
+
+Seizure‐related outcomes were commonly discussed, with "seizure freedom" coded in 15 studies and "seizure‐related injury" as a consequence of seizures in 13 studies. Seizure frequency was the third most frequently coded theme in this domain and highlighted in 10 studies, and some participants specifically discussed how improved seizure frequency often led to improved engagement with work and social functioning:I only have maybe one seizure a week now … so now I can get almost all my work done during the week and not have to catch up on weekends. [Adult with recently diagnosed epilepsy, interviewed about self‐management for epilepsy] 59
+
+Participants in four of the included studies discussed how postictal impairments (e.g., drowsiness) could be important given the potential impact on ability to function:The generalised [seizure], the recovery time as well is excessive for me, I need to sleep for hours, so, if that happens at work or when you are out, it is a, it can just ruin a day you just lose a day basically, which is not good for me. [Woman with recently diagnosed epilepsy, and person of childbearing potential] 68
+
+Other seizure‐related outcomes included aspects connected to ictal components of seizures, such as experience of auras, whether seizures generalize and therefore lead to loss of awareness, and the duration of seizures, including status epilepticus.
+
+3.4 Cognitive, behavioral, and mental health
+
+Cognitive and neuropsychiatric outcomes were also frequently considered important by PWE, with "symptoms of depression" and "memory impairment" both coded in 11 studies. Much of the verbatim text relating to depression was broad, whereas in some instances specific perceived symptoms of depression were highlighted, including reduced self‐esteem, fatigue in the context of low mood, feelings of hopelessness, negative ruminations, and suicidality. Anxiety symptoms were discussed as specific seizure‐related worry in four studies, with participants discussing feeling “nervous about going out [due to seizures],” and discussed in a more general context in eight studies.
+
+The concept of "memory impairment" was discussed by PWE as well as their caregivers, and often the verbatim text referred to the cognitive domains of working memory and attention:I had a lot of problems with the cognitive impairments. It wasn't possible to study. I couldn't, you know, prepare meals. I couldn't follow a recipe. [Participant from focus group of people with epilepsy discussing what is important for their rehabilitation] 69
+
+In addition, four participants across two studies specifically discussed the impact of word‐finding difficulty, thought to be a consequence of epilepsy or its treatment.
+
+3.5 Physical functioning, participation, and disability
+
+The impact of epilepsy on physical functioning was coded in 18 studies and varied from very specific impairments such as the ability to go swimming unattended or ride a bicycle, to more generic comments about independence and the sense of burden felt by many with epilepsy. Of note, sexual dysfunction due to epilepsy and its treatment was coded from 11 participant quotes from four studies. This included comments about lack of interest and sexual desire, difficulty with arousal and orgasm, and fear of a seizure during sexual intercourse:It's as important as the medicine, as important as knowing that I have to be careful with swimming or I should stop driving for six months. It's just as important to discuss how my sexuality is affected. Maybe it won't be affected, but it's a possibility and there are ways of treating it. [Man with epilepsy aged 49 years] 29
+
+You mentioned orgasm … this is something I only started allowing the past couple of years. Because I lose control … I think "what if I suddenly have a seizure?" [Woman with epilepsy aged 39 years] 29
+
+3.6 Emotional functioning
+
+Frequent outcomes categorized within the emotional functioning domain were "perceived stigma and discrimination," which was coded 71 times across 32 studies, and the personal "acceptance of epilepsy," which was coded 38 times across 27 studies. Stigma was discussed by participants from varied geographical regions, and from broad socioeconomic backgrounds. A person with epilepsy from rural Burkina Faso, for example, mentioned “I am not respected. I do not have the right to go to public places. I have been given a separate cup and plate. They do not want me to get married…” 36 and a young adult with focal epilepsy from Sweden discussed the difficulty with forming new relationships: “Say you meet some new people that you haven't met before and they find out you have epilepsy, well then they take three steps back, sort of.” 70 "Acceptance of epilepsy" as outcome describes a sense of coming to terms with the diagnosis and often living with seizures and their consequences. Other outcomes coded in this domain included constructs such as a "perception of being in control," a "sense of embarrassment," and "self‐confidence."
+
+3.7 Social and role functioning
+
+The most commonly coded outcome within the social and role functioning domain was "work status," coded 43 times across 25 studies, highlighting the significant impact that epilepsy can have on employment. This was impacted by many factors, including transportation difficulties due to not being able to drive and fear of seizure‐related injuries for those working with machinery, as well as stigma that may lead to discrimination:While my educational background is good, finding a job is difficult; I have tried many times without success, employers do not employ me because of my disease. As I may experience seizures on the job, I disclose my condition to potential employers, but being truthful has affected me negatively. Employers think I would infect other employees with the disease. Besides, they believe I would not perform up to expectation or that being an epileptic, I am incompetent. [Person with epilepsy from Accra, Ghana] 52
+
+Other outcomes coded within the social and role functioning domain were impact on relationships, friendships, and marriage and the impact of epilepsy on the ability to socialize. Specific reference to the impact of epilepsy and seizures on driving was coded 25 times across 20 studies and was frequently discussed by PWE in the context of their quality of life. Although restrictions for driving for PWE vary across regions, common implications included difficulty with traveling to a place of work, the inability to fulfill some employment roles due to license restrictions, struggling with fulfilling the parental role with providing transportation for children, and a sense of burden on others to help with transportation.
+
+3.8 Other impact and global quality of life
+
+Other impact and global quality of life outcomes pertain to generic comments about quality of life, well‐being, or the impact of living with epilepsy that could not be coded in any more granular detail in other sections of the taxonomy. Generic reference to quality of life was coded from three studies. 45 , 71 , 72 This domain also includes outcomes related to the financial impact of living with epilepsy, including costs for treatments.
+
+3.9 Side effects or adverse effects from treatments
+
+Outcomes relating to side effects or adverse events were coded 84 times across 29 of the included studies. The most frequently identified adverse outcome relating to treatment was "medication‐related somnolence," which was coded across nine studies and frequently involved discussion of its impact on functioning, for example, engaging with education:That medication makes me so sleepy … that's why I don't take it if I have to stay up and write a paper or have an early class. [Adult with newly diagnosed epilepsy from the USA] 59
+
+Other frequently coded outcomes within this domain included medication‐related weight gain in seven studies, medication‐related mood changes in five studies, and medication‐related cognitive disturbance also in five studies. "Impact of medications on offspring health" was coded across four studies, all discussed by women living with epilepsy:[If] I was actually planning to have a kid, or try and get pregnant and if I did I wouldn't want the Epilim to do anything, because I know there's a high chance that the Epilim would have done something to my child if I had got pregnant. I thought if I do get pregnant at least I'm not going to be damaging my child in any way. [25‐year‐old woman with a 10‐year history of seizures from the UK, discussing medication switching] 73
+
+Whereas most participants discussed this consequence broadly, some discussed specific effects, including major congenital malformations as well as neurodevelopmental outcomes for their offspring.
+
+3.10 Fertility and pregnancy, including offspring outcomes
+
+The "ability to get pregnant and have a healthy pregnancy" was coded across three studies, two of which were specifically designed to ascertain the views of women living with epilepsy. 43 , 74 Women also discussed the impact of pregnancy on seizure control and expressed anxieties about the risks of antiseizure medication in pregnancy. One woman from the included studies discussed the difficult balance between obtaining seizure control and minimizing the potential teratogenicity of antiseizure medication:[With the antiseizure medication] I wanted to reduce the risk of anything happening to the baby. But I didn't want to, you know, like double my chance of having a fit and losing the baby altogether, if you know what I mean, so I sort of had to balance baby over me. [Woman of childbearing potential with established epilepsy] 68
+
+Specific mention to antiseizure medication reducing the effectiveness of oral contraceptives and therefore increasing the risk of unintended pregnancy as an outcome was coded in two studies. 74 , 75 The ability to breastfeed was discussed in just one paper, 43 and paternal fertility was not specifically identified from the included literature.
+
+3.11 Death
+
+Mortality as an outcome was coded across six studies and discussed specifically in the context of sudden unexpected death in epilepsy (SUDEP) in two studies. As one 21‐year‐old woman with epilepsy explained, “It's just quite scary to think that one night we, any one of us, might just go to sleep and never wake up.” 75
+
+4 DISCUSSION
+
+This is the first review of qualitative studies focusing on outcomes for adults with epilepsy. Rapid review methodology and a synthesis of outcomes from the published qualitative literature has been undertaken, providing the foundation of work to develop a COS for treatment effectiveness studies for adults with epilepsy. In total, 74 articles were included, representing a variety of qualitative methodological and epistemological paradigms. The synthesized framework of 140 outcomes and nine domains represents the views of more than 3100 PWE and significant others.
+
+A major strength is that the outcomes identified come from in‐depth interviews, focus groups, and free‐text data across a range of epilepsy classifications and severities, and diverse cultural, geographical, and socioeconomic contexts. The outcomes therefore should provide insights into the full spectrum of health‐related experiences, encountered by people living with epilepsy in a diverse range of cultural contexts.
+
+Outcomes in the "social and role functioning" and "emotional functioning" domains were the most frequently coded across the included studies, with 275 and 271 quotations coded for each domain, respectively. This compares to 129 quotations coded for seizure‐related outcomes. The notion that living with epilepsy represents "more than just seizures" has been long established, 76 particularly given that psychological constructs including anxiety and depression explain approximately one third of the variance in quantitative assessments of health‐related quality of life across multiple studies in different populations, compared to one fifth of the variance explained by seizure‐related factors. 77 The high burden of neuropsychiatric "comorbidity" in epilepsy is also reflected in large population‐level studies. For instance, Danish registry data demonstrate that psychiatric comorbidity is 2–3 times higher in people living with epilepsy compared to the general population. 78 That treatment‐related adverse effects were identified as important from the qualitative literature, as indicated by the large number of codes, aligns with the findings from multiple cross‐sectional studies that demonstrate correlations between the presence of side effects and health‐related quality of life scores in PWE. 79 , 80 , 81 , 82 These established relationships likely explain why behavioral, psychiatric, and adverse event outcomes and their impact on functional status and well‐being were frequently coded from the in‐depth interview and focus group data. Of note, the outcomes identified from this review of qualitative literature strongly align with the broad range of nonseizure outcomes identified in the recently published COS for children with epilepsy 13 and adults with treatment‐refractory epilepsy in clinical settings. 14
+
+Importantly, many novel outcomes identified from this review of qualitative literature were not identified in the associated review of outcomes measured and reported in phase III and IV interventional studies for adults with epilepsy. 24 These include measuring SUDEP as a specific cause of mortality, specific cognitive impairments including word‐finding difficulty, and many well‐defined functioning status outcomes including the ability to exercise and sexual function. Other novel outcomes included emotional functioning constructs, including acceptance of a diagnosis of epilepsy, a sense of normality, and a sense of isolation. This confirms the importance of including the lived experience perspective in the early stages of developing COSs; otherwise outcomes deemed important by those with lived experience risk being missed when developing the initial list of outcomes for inclusion in the consensus process. The need to include the lived experience perspective at this stage is highlighted by the COS‐STAD (Core Outcome Set‐Standards for Development) consensus on minimum methodological standards, 83 and similar methods using qualitative reviews to identify outcomes have been successfully adopted by other COS developers. 18 , 19 , 20 , 21 , 22
+
+There are several limitations that need to be considered when interpreting the findings of this review. First, due to limited resources, rapid review methodology using only one bibliographic database, MEDLINE, was used, and the gray literature was not searched. Although this may mean that some relevant studies have been missed, the aim was not to provide an exhaustive review of all the published qualitative literature pertaining to the experience and perspectives of adults living with epilepsy, but rather to capture the likely range of outcomes considered important on the basis of lived experience for inclusion in the initial long list of outcomes that forms the basis for subsequent discussions about a COS for effectiveness studies for adults with epilepsy. This review identified outcomes from a greater number of studies compared to other COS developers, 18 , 19 including those who performed a systematic review and searched multiple bibliographic databases to identify relevant articles. 21 This may reflect that epilepsy has a high prevalence and disease burden, 84 and there has been a rich interest in researching the impact of living with epilepsy using qualitative methods historically. 85
+
+The evidence was largely concealed within the included studies, with studies only presenting pertinent participant verbatim quotes to justify theory or concepts, rather than providing full transcripts of data generated by in‐depth interviews or focus groups. For example, although some publications provided rich data from in‐depth interviews in Supporting Information, 56 others did not and included only a few quotations within the main body of the published article. 86 Not having all primary data available for analysis could mean that certain outcomes were missed by this review. It is a risk of the otherwise efficient method that was used and supports moves by some in the research community to make more available anonymized transcripts for reuse via repositories. 87 However, the likelihood that this risk was realized in the present study is low, given that such a large number of studies from varied contexts were deemed eligible and therefore included for data extraction and outcome identification. Furthermore, analysis of the outcome list from a lived experience focus group used to develop a COS for routine clinical practice for infants, children, and adults with epilepsy demonstrates that all the granular outcome concepts identified in the focus group were also identified in this review. 11 , 12
+
+Another limitation is that many studies were included where the primary aim was not to describe outcomes. The methodological rationale was that given the open‐ended nature of qualitative questioning and data generation, there was likely to be data relevant to outcomes important to adults with epilepsy whenever an experience of living with epilepsy was discussed. It is therefore possible that including studies relating to a specific experience (e.g., understanding patients' accounts of hospital consultations) 73 or a particular construct (e.g., stigma and epilepsy) 51 , 52 , 54 or intervention (e.g., epilepsy self‐management course as part of a randomized controlled trial) 50 may have impacted on the outcomes identified. However, given that 74 studies were included for data extraction and that in many of the studies with a more focused scope, data about general perceptions about living with epilepsy were still discussed, it is unlikely that important outcomes have been missed or misrepresented by including these studies.
+
+Finally, the epistemological context of this review should be noted. Verbatim text in the included studies was aggregated into an outcome framework, using a deductive approach based on the existing outcomes taxonomy. This was based on the assumption that mapping of concepts from published interview, focus group, and free‐text survey data was a valid representation of outcomes important to those with lived experience. This differed from many of the included studies, which used inductive approaches to generate new theory, for example, using ethnography and narrative research methods. The risk with this approach is that coding based on an existing outcomes taxonomy may have altered the meaning of the included participants' perspectives. However, the advantage of using an established taxonomy as a starting point for developing the outcome and domain structure was to allow for comparisons to be made with the associated systematic review of outcomes reported in clinical trials, 24 and to facilitate development of the outcome long list to take forward to the consensus process to develop a COS.
+
+5 CONCLUSIONS
+
+Rapid review methodology has been used to identify outcomes important to adults with epilepsy across published qualitative studies assessing the impact of living with epilepsy. In addition to informing the long list of outcomes to enter the consensus process to develop the COS for adults with epilepsy, the findings should have wider reaching implications by providing new insights on what matters most to people living with epilepsy in a diverse range of geographic, societal, and cultural settings. These could additionally be used to inform clinical practice and noninterventional studies.
+
+AUTHOR CONTRIBUTIONS
+
+James W. Mitchell: Conceptualization; data curation; data analysis; methodology; writing—original draft preparation; writing—review and editing. John Doherty: data analysis; writing‐review and editing. Rachel Batchelor: Data analysis; methodology; writing—review and editing. Adam Noble: Conceptualization; data analysis; methodology; writing—review and editing. Anthony Marson: Conceptualization; data analysis; methodology; writing—review and editing.
+
+CONFLICT OF INTEREST STATEMENT
+
+J.W.M. has received fees for consultancy from the International Consortium for Health Outcomes Measurement to facilitate the development of their epilepsy standard sets for routine practice. R.B. has nothing to disclose related to the submitted work. Outside the submitted work, at time of writing, R.B. was a member of the NICE Epilepsies Guideline Committee and was a lived experience representative on the RCPCH Epilepsy Board. The other authors have nothing to disclose related to the submitted work. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines
+
+Supporting information
+
+DATA S1.
+
+ACKNOWLEDGMENTS
+
+The authors would like to thank the Association of British Neurologists and Guarantors of Brain charities, who funded researcher time to undertake this work, as part of a Clinical Research Training Fellowship grant (awarded to J.W.M.).
+
+DATA AVAILABILITY STATEMENT
+
+The data that support the findings of this study are available from the corresponding author upon reasonable request.
+
+
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+53 Jacoby A , Wang W , Vu TD , Wu J , Snape D , Aydemir N , et al. Meanings of epilepsy in its sociocultural context and implications for stigma: findings from ethnographic studies in local communities in China and Vietnam. Epilepsy Behav. 2008;12:286–297.18032116 10.1016/j.yebeh.2007.10.006
+54 Espínola‐Nadurille M , Crail‐Melendez D , Sánchez‐Guzmán MA . Stigma experience of people with epilepsy in Mexico and views of health care providers. Epilepsy Behav. 2014;32:162–169.24439700 10.1016/j.yebeh.2013.12.007
+55 Paschal AM , Ablah E , Wetta‐Hall R , Molgaard CA , Liow K . Stigma and safe havens: a medical sociological perspective on African‐American female epilepsy patients. Epilepsy Behav. 2005;7:106–115.15961348 10.1016/j.yebeh.2005.03.020
+56 Michaelis R , Niedermann C , Berger B . How can we enhance the sense of self‐efficacy in epilepsy individual responses from 2 qualitative case reports. Complement Med Res. 2017;24:215–224.28848132 10.1159/000468986
+57 Pembroke S , Higgins A , Pender N , Elliott N . Becoming comfortable with “my” epilepsy: strategies that patients use in the journey from diagnosis to acceptance and disclosure. Epilepsy Behav. 2017;70:217–223. 10.1016/j.yebeh.2017.02.001 28437750
+58 Varley J , Delanty N , Normand C , Fitzsimons M . The health care journeys experienced by people with epilepsy in Ireland: what are the implications for future service reform and development? Epilepsy Behav. 2011;20:299–307.21195671 10.1016/j.yebeh.2010.10.020
+59 Unger WR , Buelow JM . Hybrid concept analysis of self‐management in adults newly diagnosed with epilepsy. Epilepsy Behav. 2009;14:89–95.18796337 10.1016/j.yebeh.2008.09.002
+60 Ridsdale L , Kwan I , Morgan M . How can a nurse intervention help people with newly diagnosed epilepsy? A qualitative study (of patients' views). Seizure. 2002;11:1–5.11888253 10.1053/seiz.2001.0599
+61 Swarztrauber K , Dewar S , Engel J Jr . Patient attitudes about treatments for intractable epilepsy. Epilepsy & Behavior. 2003;4:19–25.12609224 10.1016/s1525-5050(02)00687-x
+62 Ninnoni JPK . A qualitative study of the communication and information needs of people with learning disabilities and epilepsy with physicians, nurses and carers. BMC Neurol. 2019;19:12. 10.1186/s12883-018-1235-9 30660202 PMC6339405
+63 Thomas RH , Mullins JM , Hammond CL , Smith PEM , Kerr MP . The importance of the experiences of initial diagnosis and treatment failure when switching antiepileptic drugs. Epilepsy Behav. 2013;29:492–496.24094841 10.1016/j.yebeh.2013.08.025
+64 Vears DF , Dunn KL , Wake SA , Scheffer IE . ‘It's good to know’: experiences of gene identification and result disclosure in familial epilepsies. Epilepsy Res. 2015;112:64–71.25847340 10.1016/j.eplepsyres.2015.02.011
+65 Johannessen Landmark C , Fløgstad I , Syvertsen M , Baftiu A , Enger U , Koht J , et al. Treatment and challenges with antiepileptic drugs in patients with juvenile myoclonic epilepsy. Epilepsy Behav. 2019;98:110–116.31330379 10.1016/j.yebeh.2019.05.021
+66 Wilson IB , Cleary PD . Linking clinical variables with health‐related quality of life: a conceptual model of patient outcomes. JAMA. 1995;273:59–65.7996652
+67 Dodd S , Clarke M , Becker L , Mavergames C , Fish R , Williamson PR . A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol. 2018;96:84–92. 10.1016/j.jclinepi.2017.12.020 29288712 PMC5854263
+68 Ring A , Jacoby A , Baker G , Holmes E , Hughes D , Kierans C , et al. What really matters? A mixed methods study of treatment preferences and priorities among people with epilepsy in the UK. Epilepsy Behav. 2019;95:181–191.31071641 10.1016/j.yebeh.2019.03.033
+69 Wedlund EW , Nilsson L , Tomson T , Erdner A . What is important in rehabilitation for persons with epilepsy? Experiences from focus group interviews with patients and staff. Epilepsy Behav. 2013;28:347–353.23827317 10.1016/j.yebeh.2013.05.022
+70 Gauffin H , Flensner G , Landtblom AM . Living with epilepsy accompanied by cognitive difficulties: young adults' experiences. Epilepsy Behav. 2011;22:750–758.22019020 10.1016/j.yebeh.2011.09.007
+71 Bennett L , Bergin M , Gooney M , Doherty CP , Synnott C , Wells JSG . Epilepsy services in Ireland: ‘a survey of people with epilepsy in relation to satisfaction, preferences and information provision’. Epilepsy Res. 2015;113:11–18.25986187 10.1016/j.eplepsyres.2015.03.006
+72 Jacoby A , Ring A , Whitehead M , Marson A , Baker GA . Exploring loss and replacement of loss for understanding the impacts of epilepsy onset: a qualitative investigation. Epilepsy Behav. 2014;33:59–68.24632355 10.1016/j.yebeh.2014.02.015
+73 McCorry D , Marson T , Jacoby A . Understanding routine antiepileptic drug decisions: a qualitative analysis of patients' accounts of hospital consultations. Epilepsy Behav. 2009;14:210–214.18977312 10.1016/j.yebeh.2008.10.010
+74 Wallace HK , Solomon JK . Quality of epilepsy treatment and services: the views of women with epilepsy. Seizure. 1999;8:81–87.10222298 10.1053/seiz.1998.0266
+75 Prinjha S , Chapple A , Herxheimer A , McPherson A . Many people with epilepsy want to know more: a qualitative study. Fam Pract. 2005;22:435–441.15814581 10.1093/fampra/cmi024
+76 Mula M , Cock HR . More than seizures: improving the lives of people with refractory epilepsy. Eur J Neurol. 2015;22:24–30.25367637 10.1111/ene.12603
+77 Taylor RS , Sander JW , Taylor RJ , Baker GA . Predictors of health‐related quality of life and costs in adults with epilepsy: a systematic review. Epilepsia. 2011;52:2168–2180.21883177 10.1111/j.1528-1167.2011.03213.x
+78 Christensen J , Dreier JW , Sun Y , Linehan C , Tomson T , Marson A , et al. Estimates of epilepsy prevalence, psychiatric co‐morbidity and cost. Seizure Eur J Epilepsy. 2023;107:162–171.10.1016/j.seizure.2022.06.010 35811222
+79 Suurmeijer TPBM , Reuvekamp MF , Aldenkamp BP . Social functioning, psychological functioning, and quality of life in epilepsy. Epilepsia. 2001;42:1160–1168.11580765 10.1046/j.1528-1157.2001.37000.x
+80 Szaflarski M , Meckler JM , Privitera MD , Szaflarski JP . Quality of life in medication‐resistant epilepsy: the effects of patient's age, age at seizure onset, and disease duration. Epilepsy Behav. 2006;8(3):547–551.16483851 10.1016/j.yebeh.2006.01.001
+81 Elsharkawy AE , May T , Thorbecke R , Koch‐Stoecker S , Villagran A , Urak L , et al. Long‐term outcome and determinants of quality of life after temporal lobe epilepsy surgery in adults. Epilepsy Res. 2009;86(2‐3):191–199.19632095 10.1016/j.eplepsyres.2009.06.008
+82 Perucca P , Carter J , Vahle V , Gilliam FG . Adverse antiepileptic drug effects: toward a clinically and neurobiologically relevant taxonomy. Neurology. 2009;72:1223–1229.19349601 10.1212/01.wnl.0000345667.45642.61 PMC2677485
+83 Kirkham JJ , Davis K , Altman DG , Blazeby JM , Clarke M , Tunis S , et al. Core outcome set‐STAndards for development: the COS‐STAD recommendations. PLoS Med. 2017;14:e1002447.29145404 10.1371/journal.pmed.1002447 PMC5689835
+84 Fiest KM , Sauro KM , Wiebe S , Patten SB , Kwon CS , Dykeman J , et al. Prevalence and incidence of epilepsy. Neurology. 2017;88:296–303.27986877 10.1212/WNL.0000000000003509 PMC5272794
+85 Rapport F , Clement C , Doel MA , Hutchings HA . Qualitative research and its methods in epilepsy: contributing to an understanding of patients' lived experiences of the disease. Epilepsy Behav. 2015;45:94–100.25847427 10.1016/j.yebeh.2015.01.040
+86 RamachandranNair R , Jack SM . SUDEP: what do adult patients want to know? Epilepsy Behav. 2016;64:195–199.27743552 10.1016/j.yebeh.2016.09.022
+87 Mannheimer S , Pienta A , Kirilova D , Elman C , Wutich A . Qualitative data sharing: data repositories and academic libraries as key partners in addressing challenges. Am Behav Sci. 2018;63:643–664. 10.1177/0002764218784991 31693016 PMC6830543
diff --git a/corpus/healthcare/text/3aae3631be826c94.txt b/corpus/healthcare/text/3aae3631be826c94.txt
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@@ -0,0 +1,719 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Health Serv Res
+Journal ID: BMC Health Serv Res
+NLM Journal ID: 101088677
+
+BMC Health Services Research
+
+EISSN: 1472-6963
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12406394
+PMID: 40903718
+DOI: 10.1186/s12913-025-13410-4
+Article ID: 13410
+Article version: 1
+Subjects: Systematic Review
+
+Pathway to developing paediatric non-communicable disease guidelines in Malawi: a scoping review
+
+Moyo Dominic 1
+Nagase Megumi megumi.nagase@uni-wh.de
+2
+Msekandiana Amos 1
+Phoya Frank 3
+Chimowa Takondwa 3
+Molyneux Elizabeth M. 1
+Weigel Ralf 2
+Mbale Emmie 1
+Banda Jonathan Chiwanda 4
+Krüger Carsten 2
+Chimalizeni Yamikani 1 3
+1 https://ror.org/00khnq787 Kamuzu University of Health Sciences, Blantyre, Malawi
+2 https://ror.org/00yq55g44 grid.412581.b 0000 0000 9024 6397 Witten/Herdecke University, Witten, Germany
+3 https://ror.org/025sthg37 grid.415487.b 0000 0004 0598 3456 Queen Elizabeth Central Hospital, Blantyre, Malawi
+4 https://ror.org/0357r2107 grid.415722.7 0000 0004 0598 3405 Department of Non-Communicable Diseases, Ministry of Health, Lilongwe, Malawi
+Electronic publication date: 2025 Sep 3
+Publication date: 2025
+Volume: 25
+Electronic Location ID: 1186
+Received 2024 May 29; Accepted 2025 Aug 21
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Paediatric non-communicable diseases, Guidelines review, Quality of care, Malawi
+
+Funding: Private Universität Witten/Herdecke gGmbH (3128) Open Access funding enabled and organized by Projekt DEAL.
+
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2025
+
+Ÿ==============================Ÿ
+Background
+
+Non-communicable diseases (NCDs) in children are becoming the leading cause of morbidity and mortality globally. Low- and middle-income countries have not been spared. To improve the quality of care, there is need to use evidence-based and locally relevant interventions. Clinical practice guidelines are essential to provide recommendations that optimise and standardise care. This scoping review was performed to assess the scope, content, and structure of existing paediatric clinical practice guidelines in Africa that can inform the development of paediatric guidelines for NCDs in Malawi.
+
+Methods
+
+Pubmed, Scopus, and Cochrane databases were searched to identify paediatric NCDs guidelines from Africa published between 2003 and 2022 in English. In addition, a manual search of grey literature was conducted online and experts from centres around Africa were contacted. Four independent reviewers analysed the guidelines by answering five specific questions on their scope, structure, content, recommendations and implementation.
+
+Results
+
+A total of 19 guidelines from 13 African countries were included, seven from East Africa, four from Southern Africa and two from West Africa. There were six guidelines specifically for children while the rest were integrated guidelines for both adults and children. There were no specific guidelines for NCDs. However, common NCDs that were covered included non-accidental injuries, developmental disorders, mental health, respiratory, cardiovascular, endocrine, renal, rheumatological and haemato-oncological disorders. There was heterogeneity in how these topics were covered in that the specific paediatric guidelines had more detailed content for children than the integrated guidelines. Most guidelines lacked aspects of prevention and health promotion.
+
+Conclusion
+
+This review evaluated paediatric guidelines from Malawi and the African region to support the development of national paediatric NCD guidelines. The findings highlighted significant gaps in addressing comprehensive aspects, particularly in health promotion and prevention measures, across the 19 reviewed guidelines. Moving forward, the development of paediatric NCD guidelines for Malawi will incorporate insights from African colleagues and address identified content gaps. Addressing these gaps presents an opportunity to tackle the burden of paediatric NCDs.
+
+Background
+
+The increasing global burden of non-communicable diseases (NCDs) over the past two decades is a well-established trend, resulting in approximately 41 million deaths in adults and children annually, worldwide [1, 2]. Most of these deaths occur in low- and middle-income countries (LMICs) and sub-Saharan Africa is facing a growing NCDs epidemic [2–4]. In 2019, NCDs and injuries accounted for half of the global mortality among children aged 5 to 14 years [4, 5], and this number continues to rise. Despite clear evidence of this emerging pattern, the long-term impact of NCDs on children is often overlooked in global monitoring, goals and priorities [6]. The life-course approach suggests that childhood and early adolescence are a ´global window´ of opportunity to effectively reduce disease risk and to implement cost-effective interventions both within households and the healthcare systems [7–9].
+
+Malawi has a young population with more than half being under 18 years of age [10], and the population is predicted to nearly double by 2050 [11]. Despite the recent success in reducing the burden of infectious diseases (e.g. HIV, tuberculosis, and malaria) and reducing under-five mortality rate [12], the country suffers from the mounting threat of NCDs among the young generation. In 1990, NCDs and injuries accounted for 33 per cent of the entire disability-adjusted life years (DALYs) among 5 to 19-year-olds in Malawi, but by 2019, this rate had risen significantly to 46 per cent [5]. Mental health disorders, neoplasms, asthma, epilepsy and neurological disorders are important contributors to the DALYs [5]. Given that NCDs often go undetected and underreported where poverty prevails and diagnostic equipment is scarce [13, 14], those numbers may be the tip of the iceberg.
+
+To address these health needs, the Malawian government has developed the NCDs Action Plan 2017–2022 [15], with emphasis on prevention, cost-effectiveness, evidence-based strategies and the delivery of essential care across different levels of the health system. However, challenges persist in providing basic care for NCDs. Chronic shortage of drugs and diagnostic equipment are widespread in primary, secondary and tertiary care facilities, and the budget allocated for NCDs is disproportionately constrained by infectious diseases [16, 17]. For paediatric NCDs in particular, the severe shortage of paediatricians, with a ratio of 1 paediatrician to 300,000-500,000 children [18], and outdated resources that are primarily tailored for adults contribute to the problem. Meanwhile, an increasing number of children and adolescents are exposed to new health hazards resulting from rapid urbanisation, lifestyle changes (e.g. alcohol consumption, substance abuse, poor diet, lack of exercise), and environmental conditions affected by climate change [19]. This also jeopardises Malawi’s ability to achieve the child health targets of Sustainable Developmental Goal 3.
+
+The Institute of Medicine defines clinical practice guidelines as systematically developed statements designed to optimize patient care through evidence-based recommendations [20]. However, in resource-limited settings, locally developed guidelines may not always be strictly evidence-based, and often reflect expert consensus and contextual factors such as resource availability and healthcare challenges [21–23]. Despite this, guidelines are essential to aid healthcare professionals and patients in making informed decisions about suitable healthcare [24]. For instance, they promote proven effective treatment that consistently benefits patients, while excluding ineffective ones, and offer updated and standardised recommendations [25, 26]. These features not only improve patient health outcomes but also enhance the quality of the healthcare system as a whole [27–29]. Thus, clinical practice guidelines can be defined as structured recommendations for standardizing healthcare, guiding disease prevention, diagnosis, treatment and management, based on evidence, expert opinion, or policy considerations.
+
+The effective implementation and use of guidelines relies on their applicability to the specific environment in which they are used [27]. Therefore, the varied demands on a healthcare system, availability of equipment and medicine, expertise among healthcare workers and population patterns, need to be reflected in the guidelines [30, 31]. At present, although there are guidelines available from international and national bodies, only a handful focus on the paediatric age group in LMICs. Examples include the guidelines published by the Global Initiative for Asthma (GINASTHMA) [32] and International Diabetes Federation (IDF) [33] that distinctly target children in LMICs to optimise disease management and education, including psychological care and guidance to minimise future risk. Meanwhile, the systematic review of existing epilepsy guidelines conducted by the International League Against Epilepsy (ILAE) revealed that 29 per cent of references did not specify age groups, and only 22 per cent focused on children [34]. Only 1.6 per cent of references identified and included in the review were from Africa, with most coming from North America and Europe. This lack of relevance to the local socio-demographic, cultural and economic aspects of Malawi may result in low adherence and usability [27]. Tailored new guidelines for the Malawian context are therefore essential and entail consolidating relevant, available evidence for the needs of the child population.
+
+To fill the current gap in educational resources and skills training among healthcare workers, the Else Kröner Malawi Child Health Centre was launched within the Paediatrics and Child Health Association of Malawi (PACHA) in August 2022, in collaboration with Kamuzu University of Health Sciences (KUHeS, Malawi) and Witten/Herdecke University (UW/H, Germany). The centre will develop and implement evidence-based, locally relevant paediatric NCD guidelines that integrate disease diagnosis, treatment, prevention and promotion. As such, the primary aim of this review was to assess the structure, content and overall approach of existing paediatric guidelines in Malawi and African region as a baseline to inform newly developed child health NCDs guidelines.
+
+Methods
+
+This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) [35]. The protocol did not require ethical approval as it utilised publicly available clinical practice guidelines. The funding organisation Else Kröner-Fresenius Stiftung (EKFS) had no influence on protocol development, data analysis and writing of the manuscript.
+
+Data sources and search strategy
+
+Guidelines and academic literature meeting the eligibility criteria were searched in PubMed, Scopus, Cochrane and relevant NCD-specific associations’ websites: for example, GINASTHMA, IDF, World Child Cancer (WCC), International Society of Paediatric Oncology (SIOP), World Heart Federation (WHF), International Society for Social Pediatrics and Child Health (ISSOP), International Child Neurology Association (ICNA), and World Health Organisation (WHO). In addition, hand searches of grey literature were done on Medbox: The Aid Library [36] and Google platforms using terms “country name, children, non-communicable diseases, treatment guidelines”, and selected centres were contacted to provide guidelines in use in those centres. Ministry of Health websites were not screened systematically for relevant guidelines because they were often outdated or did not provide any additional resources. We ensured that at a minimum, the guidelines which were included had relevant stakeholder involvement and systematic methodology in their respective development as per AGREE II item 8 and 12 [37].The medical subject headings and Boolean operators used in the search strategy for online databases and Google platforms were used as in PubMed. Details are outlined in Table 1.
+
+Table 1 Search strategy (Search date: 20th June 2022)
+
+Search line	Search term	Results	
+#1	Child* OR paediatric OR pediatric OR infant OR adolescen* OR kid* OR neonate*	2,775,419	
+#2	Africa* OR Sub-Sahara*	27,030	
+#3	Guidelines OR manual OR standard treatment guidelines OR protocol	94,185	
+#4	NCDs*	27,914	
+#5	#1 AND #2	13,265	
+#6	#3 AND #4	3,689	
+#7	#5 AND #6	65	
+(“child“[MeSH Terms] OR “child“[All Fields] OR “children“[All Fields] OR “child s“[All Fields] OR “children s“[All Fields] OR “childrens“[All Fields] OR “childs“[All Fields] OR (“child“[MeSH Terms] OR “child“[All Fields] OR “children“[All Fields] OR “child s“[All Fields] OR “children s“[All Fields] OR “childrens“[All Fields] OR “childs“[All Fields]) OR (“child“[MeSH Terms] OR “child“[All Fields] OR “children“[All Fields] OR “child s“[All Fields] OR “children s“[All Fields] OR “childrens“[All Fields] OR “childs“[All Fields]) OR (“child“[MeSH Terms] OR “child“[All Fields] OR “children“[All Fields] OR “child s“[All Fields] OR “children s“[All Fields] OR “childrens“[All Fields] OR “childs“[All Fields]) OR “kid“[All Fields] OR “kids“[All Fields] OR (“infant“[MeSH Terms] OR “infant“[All Fields] OR “infants“[All Fields] OR “infant s“[All Fields]) OR (“adolescences“[All Fields] OR “adolescency“[All Fields] OR “adolescent“[MeSH Terms] OR “adolescent“[All Fields] OR “adolescence“[All Fields] OR “adolescents“[All Fields] OR “adolescent s“[All Fields]) OR (“infant“[MeSH Terms] OR “infant“[All Fields] OR “infants“[All Fields] OR “infant s“[All Fields]) OR (“infant, newborn“[MeSH Terms] OR (“infant“[All Fields] AND “newborn“[All Fields]) OR “newborn infant“[All Fields] OR “neonatal“[All Fields] OR “neonate“[All Fields] OR “neonates“[All Fields] OR “neonatality“[All Fields] OR “neonatals“[All Fields] OR “neonate s“[All Fields])) AND 2003/01/01:2023/12/31[Date - Publication] AND ((“africa“[MeSH Terms] OR “africa“[All Fields] OR “africa s“[All Fields] OR “africas“[All Fields] OR (“african people“[MeSH Terms] OR (“african“[All Fields] AND “people“[All Fields]) OR “african people“[All Fields] OR “africans“[All Fields] OR “black people“[MeSH Terms] OR (“black“[All Fields] AND “people“[All Fields]) OR “black people“[All Fields] OR “african“[All Fields])) AND “Sub-Saharan“[All Fields] AND 2003/01/01:2023/12/31[Date - Publication]) AND 2003/01/01:2023/12/31[Date - Publication] AND ((((“guideline“[Publication Type] OR “guidelines as topic“[MeSH Terms] OR “guidelines“[All Fields] OR (“practice guideline“[Publication Type] OR “practice guidelines as topic“[MeSH Terms] OR “practice guidelines“[All Fields]) OR ((“ambulatory care facilities“[MeSH Terms] OR (“ambulatory“[All Fields] AND “care“[All Fields] AND “facilities“[All Fields]) OR “ambulatory care facilities“[All Fields] OR “clinic“[All Fields] OR “clinic s“[All Fields] OR “clinical“[All Fields] OR “clinically“[All Fields] OR “clinicals“[All Fields] OR “clinics“[All Fields]) AND (“guideline“[Publication Type] OR “guidelines as topic“[MeSH Terms] OR “guidelines“[All Fields])) OR (“practice guideline“[Publication Type] OR “practice guidelines as topic“[MeSH Terms] OR “clinical practice guidelines“[All Fields])) AND (“reference standards“[MeSH Terms] OR (“reference“[All Fields] AND “standards“[All Fields]) OR “reference standards“[All Fields] OR “standardization“[All Fields] OR “standard“[All Fields] OR “standard s“[All Fields] OR “standardisation“[All Fields] OR “standardisations“[All Fields] OR “standardise“[All Fields] OR “standardised“[All Fields] OR “standardises“[All Fields] OR “standardising“[All Fields] OR “standardization s“[All Fields] OR “standardizations“[All Fields] OR “standardize“[All Fields] OR “standardized“[All Fields] OR “standardizes“[All Fields] OR “standardizing“[All Fields] OR “standards“[MeSH Subheading] OR “standards“[All Fields])) OR (“reference standards“[MeSH Terms] OR (“reference“[All Fields] AND “standards“[All Fields]) OR “reference standards“[All Fields] OR “standardization“[All Fields] OR “standard“[All Fields] OR “standard s“[All Fields] OR “standardisation“[All Fields] OR “standardisations“[All Fields] OR “standardise“[All Fields] OR “standardised“[All Fields] OR “standardises“[All Fields] OR “standardising“[All Fields] OR “standardization s“[All Fields] OR “standardizations“[All Fields] OR “standardize“[All Fields] OR “standardized“[All Fields] OR “standardizes“[All Fields] OR “standardizing“[All Fields] OR “standards“[MeSH Subheading] OR “standards“[All Fields])) AND 2003/01/01:2023/12/31[Date - Publication] AND ((“noncommunicable diseases“[MeSH Terms] OR (“noncommunicable“[All Fields] AND “diseases“[All Fields]) OR “noncommunicable diseases“[All Fields] OR (“non“[All Fields] AND “communicable“[All Fields] AND “diseases“[All Fields]) OR “non communicable diseases“[All Fields] OR “NCDs“[All Fields]) AND 2003/01/01:2023/12/31[Date - Publication]))
+
+In addition to the scoping review described above, two authors (MN and CK) assessed the coverage of the 10 paediatric NCDs with the highest burden in sub-Saharan Africa. The data used for this assessment came from the Global Burden of Disease (GBD) study [38], employing DALYs to measure the disease burden. The analysis focused specifically on the target age group of 0 to 14 years, for both females and males.
+
+Selection criteria
+
+As explained above, guidelines in our study are defined as structured recommendations aimed at improving patient care through evidence-based practices, expert opinions, and policy considerations. The 10 paediatric NCDs selected here are introduced in the following section. The guidelines that were included met the following criteria: (1) published between 2003 and 2022 (2), from the sub-Saharan African region but were also considered other LMICs with similar sociodemographic profiles to Malawi and (3) aligned with the WHO recommendations or guidelines as evidenced by citations of specific WHO guidelines on particular diseases within the documents.
+
+The guidelines were restricted to those published in English. General paediatric guidelines and country-specific, standard treatment guidelines were considered for review if they contained sections on NCDs applicable to children.
+
+Selected guidelines themes for review
+
+The guidelines were evaluated according to ten specific themes of paediatric non-communicable conditions; (i), child protection, (ii) developmental disorders, (iii) mental health, (iv) neurological disorders, (v) respiratory disorders, (vi) cardiovascular disorders, (vii) endocrine disorders, (viii) rheumatology (ix) renal disorders, and (x) haemato-oncological disorders. Child protection was included in this review as part of NCDs, specifically addressing child abuse, non-accidental injuries, and children’s rights. These issues are crucial to the overall well-being of children, extending beyond the clinical aspects of health. In Malawi, the Child Care, Protection, and Justice Act acknowledges the importance of these matters. However, there are no specific guidelines dedicated to them within the Act, as they are not categorized as communicable diseases or organ disorders.
+
+Data extraction and analysis
+
+Screening of the literature for this scoping review was done manually. Four paediatric consultants (DM, AM, FP and TC) who deliver clinical care at central hospitals in the country developed specific questions and a data extraction form. The questions to be answered included: (1) what guidelines are available for NCDs in the paediatric population in Africa (2), what is the specific structure of the available guidelines, specifically looking at the setting (whether applicable for inpatient or outpatient use) and at which level of care (whether primary, secondary or tertiary care) (3), whether the guidelines make specific recommendations on disease promotion, prevention, diagnosis and management at various levels of care (4), who are the end users of the guidelines and the guideline implementation strategy (5), which specific NCDs are covered in the guidelines. The four reviewers each reviewed at least two of the following topics: cardiovascular and haemato-oncological diseases, endocrine and respiratory diseases, renal and rheumatological diseases, neurological, developmental, mental health diseases and child protection. Initial findings of the review were presented to the UW/H-EKFS paediatric NCDs guidelines group for refining and selection of conditions to be included in the final extraction and analysis. Disagreements were resolved by consensus among the four consultants or with the involvement of members of the UW/H-EKFS paediatric NCDs guidelines group.
+
+Narrative synthesis of the guidelines was used to summarise the findings according to the predefined categories and questions set out at the beginning of the extraction exercise. Quality assessment of the guidelines and critical appraisal of the evidence supporting the guidelines were considered to be beyond the scope of the review.
+
+Results
+
+Search and screening
+
+A total of 84 citations were screened between 7 June 2022 to 29 July 2022 of which 19 were selected for retrieval and full-text review after meeting the eligibility criteria (Fig. 1). The 19 guidelines were from 13 African countries, seven from East Africa, four from Southern Africa and two from West Africa and were published by their respective Ministries of Health. Six guidelines were specifically for children less than 15 years of age, while the rest were integrated guidelines for adults and children.
+
+Fig. 1 PRISMA flowchart
+
+Scope and structure of the guidelines
+
+Of the 19 reviewed guidelines, their coverage of the 10 child NCDs with the highest burden of disease (DALY) in sub-Saharan Africa is shown in Fig. 2. For age category 0–14 yrs, both sexes, the DALYs for the following 10 major paediatric NCD categories are: congenital disorders 6.38%; psychiatric disorders including depression, autism spectrum disorders, ADHD 1.14%; haemoglobinopathies including sickle cell disease and anaemia 1%; leukemia, lymphoma, other malignancies 0.74%; asthma 0.5%; sudden infant death syndrome 0.43%; cardiovascular disorders including rheumatic heart disease and cardiomyopathies 0.41%; epilepsy 0.41%; stroke (most likely due to sickle cell disease) 0.22%; diabetes mellitus and endocrine disorders 0.2%. Asthma, epilepsy, diabetes and haemoglobinopathies are mostly well covered whereas sudden infant death syndrome is not and congenital disorders and malignancies are insufficiently covered.
+
+Fig. 2 Heatmap - Coverage for the 10 child NCDs with the highest burden of disease (DALYs) in sub-saharan Africa within the reviewed guidelines*# *: Reviewed diseases in the respective category: (1) depression, autism spectrum disorders (2), sickle cell disease, anaemia (3), leukemia, lymphoma, other malignancies (4), rheumatic heart disease, cardiomyopathies #: Assessment grading - green: the disease(s) is (are) covered with focus on children, yellow: the disease(s) is (are) covered but without focus on children or is (are) partly covered, red: the disease(s) is (are) not covered §: figure in brackets – year of publication; figure in square brackets – reference number
+
+The characteristics of the guidelines are summarised in Table 2. Generally, the guidelines provided a brief background, causes or risk factors of the conditions, clinical features (e.g. signs and symptoms and salient examination findings), investigations and both pharmacological and non-pharmacological management. Some guidelines, such as the ones from South Africa [39, 40] and Tanzania [41], included sections on screening and diagnostic criteria for specific conditions, complications, referral criteria and a formulary. Overall, sections on health promotion and prevention of specific disease conditions were poorly covered for all topics except oncology, rheumatology and renal disorders. The integrated guidelines for both adults and children had limited scope and coverage of paediatric NCDs compared to those specifically for children. Several NCDs were not covered in many of the guidelines or covered under other conditions. For example, juvenile idiopathic arthritis was mentioned as an orthopaedic condition, since it is not yet recognised as a major contributor to NCDs in most African countries. With regards to child protection, most guidelines referred to local child law legislation which varies from country to country and focused on sexual abuse but lacked advice for other forms of child abuse.
+
+Table 2 Characteristics of the 19 guidelines from 13 African countries
+
+Year	Country/Organisation	Title	Scope	Paediatric NCDs included*	Level of care	Setting	Implementation	Recommendations#	
+2003	Seychelles	Standard Treatment Guidelines [63]	- Adults and children
+
+- Systems approach
+
+	Yes
+
+iii, iv, v, vi, vii, ix
+
+	All levels	In- and out- patients	All health care workers	Promotion: little
+
+Prevention: little
+
+Diagnosis: some
+
+Management: some
+
+	
+2006	Southern Sudan	Prevention and Treatment Guidelines for Primary Health Care Centres and Hospitals [64]	- Adults and children
+
+- Include formulary (essential medicines list)
+
+	Yes
+
+iii, iv, v, vi, vii, viii, ix
+
+	All levels	In- and out- patients	All health care workers	Promotion: some
+
+Prevention: good
+
+Diagnosis: some
+
+Management: some
+
+	
+2008	Malawi	Paediatric Handbook for Malawi [43]	- Paediatrics
+
+- Systems, symptoms and disease specific
+
+- Includes formulary, growth charts and procedures
+
+	Yes
+
+i, ii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In-patients	Clinicians	Promotion: some
+
+Prevention: good
+
+Diagnosis: some
+
+Management: good
+
+	
+2009	Kenya	Clinical Guidelines for Management of referral of common conditions at level 1: community [65]	- Adults and children	Yes
+
+i, ii, iii, iv, v, vi, vii, viii
+
+	Community	Out-patients	Community Health Workers	Promotion: good:
+
+Prevention: good
+
+Diagnosis: little
+
+Management: very little
+
+	
+2011	Namibia	Namibia Standard Treatment Guidelines [66]	- Adults and children
+
+- Large section on accidents and trauma
+
+	Yes
+
+ii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out- patients	All health care workers	Promotion: good
+
+Prevention: good
+
+Diagnosis: some
+
+Management: some
+
+	
+2012	Rwanda	Paediatric Clinical Treatment Guidelines [67]	- Paediatrics	Yes
+
+iii, iv, v, vi, vii, viii, ix
+
+	Secondary and tertiary level	In- and out- patients	All health care workers	Promotion: none
+
+Prevention: none
+
+Diagnosis: good
+
+Management: good
+
+	
+2013	Kenya	Basic Paediatric Protocols for ages up to 5 years [68]	- Paediatrics	Yes
+
+iv, v, vi, vii, viii
+
+	All levels	In- and out- patients	All health care workers	Promotion: none
+
+Prevention: very little
+
+Diagnosis: some
+
+Management: some
+
+	
+2014	Ethiopia	Standard Treatment Guidelines for Primary Hospital [69]	- Adults and children
+
+- Systems approach
+
+	Yes
+
+iii, iv, v, vi, vii, viii, ix
+
+	Primary care	Out-patients	Clinicians	Promotion: none
+
+Prevention: little
+
+Diagnosis: little
+
+Management: good
+
+	
+2014	Ethiopia	Standard Treatment Guidelines for General Hospital [70]	- Adults and children	Yes
+
+iii, iv, v, vi, vii, viii, ix
+
+	Secondary and tertiary care	In- and out-patients	All health care workers	Promotion: none
+
+Prevention: little
+
+Diagnosis: some
+
+Management: some
+
+	
+2015	Malawi	Malawi Standard Treatment Guidelines [71]	- Adults and children
+
+- Includes formulary (essential medicines list)
+
+	Yes
+
+iii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out- patients	All health care workers	Promotion: none
+
+Prevention: little
+
+Diagnosis: some
+
+Management: some
+
+	
+2016	Uganda	Uganda Clinical Guidelines [45]	- Adults and children
+
+- Use systems approach + with some specific diseases
+
+- Includes drug formulary (essential medicines list)
+
+	Yes
+
+ii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out- patients	Targets different cadres - doctors, nurses, community health workers	Promotion: little
+
+Prevention: some
+
+Diagnosis: some
+
+Management: some
+
+	
+2017	South Africa	Standard Treatment Guidelines and Essential Medicines List for South Africa (Hospital level paediatrics) [39]	- Paediatrics
+
+- Uses systems approach and includes emergencies and trauma
+
+- Includes formulary (essential medicines list)
+
+	Yes
+
+(i), ii, iii, iv, v, vi, vii, viii, ix, (x)
+
+	All levels	In- and out- patients	All health care workers	Promotion: little
+
+Prevention: some
+
+Diagnosis: good
+
+Management good
+
+	
+2017	Malawi	Protocols for the management of common childhood illnesses in Malawi (Hospital) [44]	- Paediatrics
+
+- Uses systems and disease specific approach
+
+- Included formulary (essential medicines list)
+
+	Yes
+
+i, ii, iii, iv, v, vi, vii, viii, ix
+
+	All levels	In- and out- patients	All health care workers	Promotion: little
+
+Prevention: little
+
+Diagnosis: good
+
+Management: good
+
+	
+2017	Ghana	Standard Treatment Guidelines [72]	- Adults and children
+
+- Uses both systems, symptoms and disease specific approach
+
+	Yes
+
+i, iii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out- patients	All health care workers	Promotion: little
+
+Prevention: little
+
+Diagnosis: good
+
+Management: good
+
+	
+2017	Liberia	National Standard Therapeutic Guidelines and Essential Medicines List [73]	- Adults and children
+
+- Uses systems and disease specific approach
+
+- Includes formulary
+
+	Yes
+
+iii, iv, v, vi, vii, viii, ix, (x)
+
+	All levels	In- and out- patients	All health care workers	Promotion: none
+
+Prevention: little
+
+Diagnosis: little
+
+Management: moderate
+
+	
+2018	Tanzania	Standard Treatment Guidelines and Essential Medicines List for Children and Adolescents [41]	- Paediatrics
+
+- Combination of systems, symptoms and disease specific
+
+- includes formulary
+
+	Yes
+
+ii, iii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out-patients	All health care workers	Promotion: some
+
+Prevention: some
+
+Diagnosis: some
+
+Management: moderate
+
+	
+2018	Kenya	Kenya National Guidelines for Cardiovascular diseases management [46]	- Adults and children	Yes
+
+vi
+
+	All levels	In- and out- patients	All health care workers	Promotion: some
+
+Prevention: some
+
+Diagnosis: good
+
+Management: good
+
+	
+2020	South Africa	Standard Treatment Guidelines and Essential Medicines List for South Africa (Primary Healthcare level) [40]	- Adults and children
+
+- Uses systems, symptoms and disease specific approach
+
+	Yes
+
+i, iii, iv, v, vi, vii, viii, (x)
+
+	Primary level	In- and out- patients	All health care workers	Promotion: moderate
+
+Prevention: moderate
+
+Diagnosis: little
+
+Management: some
+
+	
+2020	Zambia	Standard Treatment Guidelines [74]	- Adults and children
+
+- Includes formulary (essential medicines list)
+
+	Yes
+
+iii, iv, v, vi, vii, viii, ix, x
+
+	All levels	In- and out- patients	All health care workers	Promotion: some
+
+Prevention: good
+
+Diagnosis: moderate
+
+Management: moderate
+
+	
+*: Categories: (i) child protection, (ii) developmental disorders, (iii) mental health disorders, (iv) neurological disorders, (v) respiratory disorders, (vi) cardiovascular disorders, (vii) endocrine disorders, (viii) renal disorders, (ix) rheumatological disorders, and (x) haemato-oncological disorders
+
+#: Assessment grading – none: not present; very little: few short remarks; little: short remarks on some aspects; some: coverage of some aspects; moderate: more extensive coverage of the aspects; good: sufficient, appropriate coverage
+
+All the guidelines were available as soft copies, but without quick links to chapters or topics it was sometimes a lengthy process to find a topic of immediate interest.
+
+Guidelines implementation and use
+
+The preface of most guidelines indicated that they were for use at various levels of health care and applicable to both inpatients and outpatients, but the guidelines were mostly skewed towards clinical case management at secondary and tertiary facility level, with suggestions for referral to a higher level of health care for specific trigger clinical signs and symptoms. The Standard Treatment Guidelines and Essential Medicines List for South Africa - Hospital Level Paediatric Guidelines [39] were the most comprehensive guidelines among those reviewed.
+
+Child protection
+
+In most sub-Saharan African countries, legal frameworks exist in the form of a Children´s Act (named differently in different jurisdictions) that define the necessary measures to be taken for children at risk. The acts/legal instruments are applicable at all levels of the healthcare system and intended for use by all healthcare workers involved in child care to ensure a multidisciplinary approach.
+
+Developmental, mental and neurological disorders
+
+The guidelines for these disorders were primarily relevant at secondary and tertiary health care level and directed towards clinical management. For neurological disorders such as epilepsy most local guidelines are based on guidelines of the International League Against Epilepsy [42]. The guidelines for Tanzania [41], South Africa [39], and Malawi [43, 44] include sections addressing cerebral palsy. The Malawian Paediatric Handbook [43] and the South African Paediatric Hospital Level Standard Treatment Guidelines [39] address autism spectrum disorders. The Tanzanian [41] and South African guidelines [39, 40] cover attention deficit hyperactive disorder (ADHD). Guidelines addressing anxiety, depression, and post-traumatic stress disorder (PTSD) were available in South Africa [39, 40], Uganda [45], and Tanzania [41]. On the other hand, none of the reviewed guidelines within Africa cover global developmental delay and intellectual disability. Likewise, aspects of promotion and prevention were hardly addressed.
+
+Cardiovascular disorders
+
+Guidelines variously include critical examination findings, diagnostic criteria and a section on when to refer. Kenya has separate comprehensive guidelines for cardiovascular diseases [46] which include common paediatric problems and a section on newborn screening for congenital cardiac diseases. The South African guidelines [39] address cardiac emergencies and common arrhythmias. Most guidelines use ICD-10 coding for each disease. They generally employ umbrella categories rather than specific diagnoses, except for the more common conditions such as acute rheumatic fever, rheumatic heart disease, and tetralogy of Fallot. These guidelines primarily focus on inpatient clinical management. Kenya, notably, has a separate guideline for use in the community that outlines when and how to refer children with specific conditions and includes community education, promotion and prevention.
+
+Rheumatological and renal disorders
+
+There is a predominant focus on arthritis, with limited coverage of other rheumatic conditions. The guidelines are for a clinical setting, both in and out-patient and due to the specialised nature of various tests required, most guidelines are applicable to the tertiary setting. Recommendations encompass both pharmacological and non-pharmacological interventions for diagnosis and management, providing comprehensive guidance for healthcare professionals in these areas, specifically tailored for implementation in tertiary care clinical settings.
+
+Respiratory diseases
+
+Asthma was found to be the primary NCD discussed in all the African guidelines that concentrated on diagnosis and effective case management. Preventive measures are typically integrated into the long-term management strategy outline in the guidelines.
+
+Haematology and oncology
+
+The guidelines are for clinical use in hospitalised patients. Although applicable at the tertiary level, most guidelines do not offer specific details on chemotherapy protocols. Oncology guidelines are often adapted from the national comprehensive cancer network. Sickle cell disease guidelines are developed by a team of experienced clinicians and researchers with input from local authorities. While cancer awareness resources are available, they are not explicitly included as part of the guidelines. Most guidelines provide a brief overview of prevention strategies.
+
+Endocrine disorders
+
+The guidelines focus on tailored clinical case management and provide a series of prompts to assist clinicians. The main objectives are to prevent complications associated with underlying conditions, such as providing dietary recommendations for Type 1 diabetes. Overall, these guidelines are designed to aid clinicians in managing patients at the secondary or tertiary level of care, both in hospital and outpatient settings.
+
+Discussion
+
+The review included 19 guidelines from 13 African countries to inform the development of Malawian guidelines for NCDs in children. The selected guidelines generally had sections on background, causes, clinical features, investigations, and management, but often lacked comprehensive coverage of health promotion and preventive measures. Most guidelines were available digitally but lacked quick links to specific topics. They were skewed towards clinical case management at secondary and tertiary levels of healthcare, potentially neglecting primary care needs.
+
+During the search of guidelines, we became aware that there is either remarkable inaccessibility or unavailability of guidelines specifically tailored to the paediatric population and also to the demands of the region/country [27]. Firstly, there is a scarcity of paediatric guidelines that adequately cover NCDs on the continent, in contrast to the greater availability of guidelines that primarily address infectious diseases such as HIV/AIDS, tuberculosis and malaria. Secondly, while the majority of health facilities have guidelines tailored to their specific centers, they are often not readily accessible beyond their respective centers. This limits opportunities for individuals seeking relevant sources to become aware of the existence of such guidelines and to access potentially valuable information. Furthermore, restricting knowledge sharing among regions or countries could negatively impact users of guidelines. They might find differences in knowledge and practices depending on where they are. Additionally, organisations or instituations may struggle to utilise existing literature when creating new guidelines [27]. Lastly among the 19 guidelines reviewed, seven were published more than 10 years ago (before 2014). This may mean that some of them do not reflect current practices and may be outdated [47]. As a result, healthcare workers may be guided to use treatments that do not produce the optimal outcomes [26].
+
+Guidelines are crucial for facilitating effective healthcare by providing a standardised approach to care delivery tailored to specific country or regional resources [25]. They also serve as valuable tools for improved and cost-effective healthcare [48–52]. However, as noted in the results section, the guidelines’ predominant focus on adults, particularly in the established, national treatment guidelines, restricts their usefulness for child health professionals. Even when guidelines cover both adults and children, they may lack sufficient detail on paediatric diseases, limiting the guidelines´ benefits for the paediatric population. Further, particularly for paediatric NCDs services, such limitations could influence resource allocation, which has a high potential to improve quality of care.
+
+The reviewed guidelines also overlook some aspects of the care delivery pathway, as well as components of health promotion and prevention. A care delivery pathway includes seamless care from community level to tertiary or quaternary levels. Illustrating this pathway in guidelines gives healthcare workers a clear coordinated plan to follow and helps providers at different facility levels by defining their roles [53, 54]. Consequently, patient care is consistent and transfer of patients between different levels of care facilities is smooth [53, 55, 56]. Moreover, integration of health promotion and prevention strategies into guidelines can foster a more holistic approach to patient care, that focuses not only on treating current conditions, but also on preventing future illness and complications and comorbidity [57–59]. For instance, guidelines may outline how to prevent childhood obesity as a significant risk factor for future conditions like diabetes mellitus and hypertension and offer evidence-based health promotion interventions. Providing guidance on these matters, including facilitating early screening and detection to patients can serve as a proactive measure to mitigate and prevent future health risks.
+
+Recommendations
+
+Based on the review, future paediatric NCDs guidelines should consider to:
+
+Outline a service delivery model for every condition at each level of care, specifying the activities to be carried out at that level.
+
+Add the transition of care for children into adult-oriented care and determine the appropriate age/state.
+
+Focus on care delivery measures, as well as include a broad range of allied health services and adopt a dynamic view of the healthcare system through delineation of the roles of various allied healthcareworkers and services.
+
+Emphasise quality improvement and develop accompanying indicators (to ensure that routine monitoring of disease trends and outcomes is carried out).
+
+Include comprehensive topic-specific public health measures, such as prevention, screening, and health promotion for every topic.
+
+Strengths and limitations
+
+To our understanding, this is the first scoping review on paediatric guidelines in sub-Saharan Africa, and will inform the development of country-specific paediatric NCDs guidelines in Malawi. The review and the recommendations for new paediatric NCDs guidelines address the demand for guidelines that are tailored to a specific local environment in sub-Saharan Africa, but are potentially useful to a wider audience given the scarcity of locally developed guidelines in most LMICs [27, 60, 61]. Close alignment with the local contexts may improve the quality of care and health outcomes for patients [62]. In addition, the review conducted by local paediatric experts, safeguards a thorough understanding of the subject and identifies areas for improvement in guideline development.
+
+However, the review has limitations. Guidelines written in English exclude guidelines published in other languages, such as French, which is in common use in West Africa. Although hand searches of grey literature were carried out, relying solely on Google platforms and contacting selected centres, but not including scientifically approved search tools for screening, may not capture all relevant grey literature. Lastly, including only guidelines published in the last 20 years may result in missing older guidelines that may still contain valuable information.
+
+Conclusion
+
+We reviewed 10 topics of paediatric NCD conditions mainly from grey literature that covered a wide range of NCD topics. The majority of guidelines were hospital and/or clinic-oriented and mainly applicable to secondary or tertiary level facilities. Many guidelines combined the care of adults and children with only a third (31%) focusing solely on paediatrics. Nearly all the guidelines failed to include public health aspects and had little or no information on health education, promotion and prevention. By incorporating these comprehensive aspects across the entire spectrum of childhood NCDs, guidelines could have a significant impact on reducing the burden of these conditions. Nevertheless, most of the guidelines took a multidisciplinary approach to managing various clinical conditions and offered referral options to the next level of care where applicable. Thus, the development of paediatric NCD guidelines for Malawi will benefit from the experience and output of our African colleagues and any gaps in content will be carefully considered.
+
+Abbreviations
+
+ADHD Attention deficit hyperactive disorder
+
+AGREE II Appraisal of Guidelines for Reseach and Evaluation II
+
+DALYs Disability-Adjusted Life Years
+
+EKFS Else Kröner-Fresenius-Stiftung
+
+GBD Global Burden of Disease
+
+GINASTHMA Global Initiative for Asthma
+
+ICNA International Child Neurology Association
+
+IDF International Diabetes Federation
+
+ILAE International League against Epilepsy
+
+ISSOP International Society for Social Paediatrics and Child Health
+
+LMICs Low-and-Middle-Income Countries
+
+NCDs Non-Communicable Diseases
+
+PACHA Paediatric and Child Health Association of Malawi
+
+PRISMA-ScR Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+PTSD Post-traumatic stress disorder
+
+SIOP International Society of Paediatric Oncology
+
+UWH Witten/Herdecke University
+
+WCC World Child Cancer
+
+WHF World Heart Federation
+
+WHO World Health Organization
+
+Acknowledgements
+
+We would like to express our sincere gratitude to our colleagues at the Paediatrics and Child Health Association of Malawi, for their assistance in finding guidelines for this review. We also want to acknowledge the support from Felix Malambwano, Chifundo Mchawa and Emmanuel Mphepo at Paediatrics and Child Health Association of Malawi, for implementing the paediatrics NCD guidelines project from the onset till this day.
+
+Author contributions
+
+YC, CK and RW conceived the project and planned the review. DM, AM, FP and TC designed the search strategy, conducted the search, reviewed the guidelines, and drafted the methods, results, discussions and conclusions sections. MN designed and revised the manuscript and wrote the background section. DM created the initial draft of tables and figures. EMM revised tables. YC, CK, RW, EMM, EM and JC critically reviewed and commented on the draft manuscript and approved the final version. Finally, all authors contributed to the manuscript through critical reviews and subsequent iterations and approved the final manuscript.
+
+Funding
+
+Open Access funding enabled and organized by Projekt DEAL. This work was funded by the Else Kröner-Fresenius-Stiftung (grant number 2021_EKHS.53). The funder did not have any influence on the data collection, analysis, interpretation and manuscript preparation.
+
+Data availability
+
+No datasets were generated or analysed during the current study.
+
+Declarations
+
+Ethics approval and consent to participate
+
+The protocol did not require ethical approval as it utilised publicly available clinical practice guidelines.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+Dominic Moyo, Megumi Nagase, Carsten Krüger and Yamikani Chimalizeni contributed equally to this work.
+
+
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+Hempel S, Ganz D, Saluja S, Bolshakova M, Kim T, Turvey C, et al. Care coordination across healthcare systems: development of a research agenda, implications for practice, and recommendations for policy based on a modified delphi panel. BMJ Open. 2023;13(5):e060232.37197809 10.1136/bmjopen-2021-060232 PMC10193077
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+Van Houdt S, Heyrman J, Vanhaecht K, Sermeus W, De Lepeleire J. Care pathways across the primary-hospital care continuum: using the multi-level framework in explaining care coordination. BMC Health Serv Res. 2013;13:296.23919518 10.1186/1472-6963-13-296 PMC3750930
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+De Bleser L, Depreitere R, De Waele K, Vanhaecht K, Vlayen J, Sermeus W. Defining pathways. J Nurs Manag. 2006;14(7):553–63.17004966 10.1111/j.1365-2934.2006.00702.x
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+Ali A, Katz DL. Disease prevention and health promotion: how integrative medicine fits. Am J Prev Med. 2015;49(5 Suppl 3):S230-40.26477898 10.1016/j.amepre.2015.07.019 PMC4615581
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+Lee A. Health-promoting schools: evidence for a holistic approach to promoting health and improving health literacy. Appl Health Econ Health Policy. 2009;7(1):11–7.19558191 10.2165/00148365-200907010-00002
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+Sanders LM, Shaw JS, Guez G, Baur C, Rudd R. Health literacy and child health promotion: implications for research, clinical care, and public policy. Pediatrics. 2009;124(Suppl 3):S306-14.19861485 10.1542/peds.2009-1162G
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+Tabyshova A, Hurst JR, Soriano JB, Checkley W, Wan-Chun Huang E, Trofor AC, et al. Gaps in COPD guidelines of Low- and Middle-Income countries: A systematic scoping review. Chest. 2021;159(2):575–84.33038390 10.1016/j.chest.2020.09.260 PMC7856534
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+Owolabi MO, Yaria JO, Daivadanam M, Makanjuola AI, Parker G, Oldenburg B, et al. Gaps in guidelines for the management of diabetes in low- and middle-income versus high-income countries-a systematic review. Diabetes Care. 2018;41(5):1097–105.29678866 10.2337/dc17-1795 PMC5911785
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Mol Neurobiol
+Journal ID: Mol Neurobiol
+NLM Journal ID: 8900963
+
+Molecular Neurobiology
+
+ISSN: 0893-7648
+EISSN: 1559-1182
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13369440
+PMID: 42446758
+DOI: 10.1007/s12035-026-06067-5
+Article ID: 6067
+Article version: 1
+Subjects: Correction
+
+Correction: APOE4-Expressing Astrocytes Exhibit Parkinson’s Disease–Related Pathology
+
+Nechushtai Lior
+Popov Anna
+Haklai Roni
+Michaelson Daniel M.
+Frenkel Dan
+Pinkas-Kramarski Ronit lironit@tauex.tau.ac.il
+
+https://ror.org/04mhzgx49 grid.12136.37 0000 0004 1937 0546 School of Neurobiology, Biochemistry and Biophysics, Department of Neurobiology, Tel-Aviv University, Ramat-Aviv, 69978 Israel
+Electronic publication date: 2026 Jul 14
+Print publication date: 2026
+Volume: 63
+Issue: 1
+Electronic Location ID: 759
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: APOE4-Expressing Astrocytes Exhibit Parkinson’s Disease–Related Pathology 63 1 11 6 2026 690 Molecular Neurobiology 10.1007/s12035-026-05996-5 PMC13260029 42274838
+issue-copyright-statement: © Springer Science+Business Media, LLC, part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Correction: Molecular Neurobiology (2026) 63:690
+
+10.1007/s12035-026-05996-5
+
+In the original version of this article, the given and family names of authors were incorrectly structured as N. Lior, P. Anna, H. Roni, M. M. Daniel, F. Dan and P. K. Ronit. The correct citation should be: L Nechushtai, A Popov, R Haklai, DM Michaelson, D Frenkel, R Pinkas-Kramarski.
+
+The original article has been corrected.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Pregnancy
+Journal ID: J Pregnancy
+NLM Journal ID: 101553823
+Journal ID: JP
+
+Journal of Pregnancy
+
+ISSN: 2090-2727
+EISSN: 2090-2735
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13315824
+PMID: 42374881
+DOI: 10.1155/jp/6613889
+Article ID: JP6613889
+Article version: 1
+Subjects: Review Article, Article
+
+The Impact of Restrictive Abortion Laws on Medical Residency Applications and Healthcare Access: Implications for Maternal Health Equity
+
+Gully Brooke https://orcid.org/0009-0008-7047-7150 1
+Whitney Ellie https://orcid.org/0009-0006-0722-1908 1 ellie.whitney@tcu.edu
+
+Johnson Paige https://orcid.org/0009-0003-2891-7769 1
+Combs Shanna https://orcid.org/0000-0002-1663-3975 2
+Chaudhary Nidhi nchaudhary@wiley.com
+
+1 Department of Medical Education , Anne Burnett Marion School of Medicine at TCU , Fort Worth , Texas , USA
+2 Department of Obstetrics and Gynecology , Anne Burnett Marion School of Medicine at TCU , Fort Worth , Texas , USA
+Electronic publication date: 2026 Jun 30
+Publication date: 2026
+Volume: 2026
+Electronic Location ID: 6613889
+Revised 2026 Jun 12; Received 2025 Jun 3; Accepted 2026 Jun 19
+Copyright: Copyright © 2026 Brooke Gully et al. Journal of Pregnancy published by John Wiley & Sons Ltd.
+Copyright year: 2026
+License: This is an open access article under the terms of the https://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Figure count: 0
+Table count: 0
+Reference count: 17
+Page count: 6
+
+source-schema-version-number: 2.0
+cover-date: 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.8.2 mode:remove_FC converted:30.06.2026
+
+Gully, Brooke , Whitney, Ellie , Johnson, Paige , Combs, Shanna , The Impact of Restrictive Abortion Laws on Medical Residency Applications and Healthcare Access: Implications for Maternal Health Equity, Journal of Pregnancy, 2026, 6613889, 6 pages, 2026. 10.1155/jp/6613889 42374881
+
+Academic Editor: Nidhi Chaudhary
+
+Ÿ==============================Ÿ
+The 2022 Supreme Court ruling in Dobbs v. Jackson Women′s Health Organization returned regulatory authority over abortion to the states and precipitated a wave of restrictive state‐level legislation. This narrative review examines how these state responses have influenced medical residency applications, physician training, and maternal health equity. Existing research indicates that restrictive state laws have contributed to a decline in residency applications to programs in jurisdictions with near‐total abortion bans. A growing body of evidence suggests that many medical students, particularly those seeking OBGYN training, prioritize programs in states with fewer restrictions to ensure comprehensive clinical education. These trends may exacerbate existing maternity care deserts by contributing to physician shortages, particularly in underserved and rural areas. The review further explores how the post‐Dobbs regulatory environment impacts physician training. Many OBGYN residency programs in restrictive states struggle to provide abortion training, often requiring residents to travel out of state, which creates significant financial and logistical burdens. Additionally, a lack of transparency regarding training availability in these states complicates the ability of prospective residents to assess program offerings. Beyond residency applications, these state‐level restrictions have affected practicing physicians, contributing to burnout, legal uncertainties, and ethical dilemmas. Many providers in restrictive jurisdictions report moral distress and legal risks when making clinical decisions, leading some to relocate to states with greater reproductive freedoms. The compounded effects of these laws may widen healthcare disparities, disproportionately affecting marginalized communities, particularly low‐income individuals and people of color. Given the limited longitudinal evidence since Dobbs, continued monitoring of OBGYN residency applications, training availability, workforce distribution, and maternal health outcomes is needed to determine the persistence and magnitude of these effects.
+
+1. Introduction
+
+From the formation of the American Medical Association (AMA) in 1847 to the landmark 1973 ruling in Roe v. Wade and its subsequent overturning in 2022, abortion has remained a centerpiece of legal and ethical controversy in the United States [1]. The initial push for legalization was driven largely by rising mortality rates from unsafe, clandestine procedures; the Guttmacher Institute found that in 1930 alone, illegal abortions accounted for one in five maternal deaths [2]. Even before federal legalization in 1973, Hawaii, California, New York, and Alaska had repealed their abortion bans, illustrating that reproductive healthcare policies and attitudes have historically been heterogeneous across state lines.
+
+Physicians and the broader medical community have consistently been impacted by and have actively shaped these legislative shifts. Although the AMA was involved in the initial criminalization of abortion in the mid‐19th century, the profession later became instrumental in reform efforts. A pivotal moment was the “Trial of the San Francisco Nine” in 1966, in which nine prominent obstetricians faced the revocation of their medical licenses by the California Board of Medical Examiners. These physicians had performed hospital‐approved abortions for patients exposed to a rubella epidemic, citing the high risk of severe fetal anomalies, a practice that, while medically accepted, was technically illegal under California′s 1872 antiabortion statute. The case became a “catalyst for change” because it shifted the debate from criminal activity to professional medical judgment. The “Nine” received unprecedented support from the academic medical community; the deans of 128 out of 134 US medical schools signed an amicus curiae brief on their behalf, arguing that medical education and practice must be governed by clinical evidence rather than rigid, antiquated statutes [1]. This defense successfully framed abortion as a component of comprehensive medical care, ultimately leading to California′s Therapeutic Abortion Act of 1967 and cementing the historical link between abortion access, physician autonomy, and the integrity of medical education.
+
+Following the Supreme Court′s decision in Planned Parenthood v. Casey (1992), state‐level abortion laws became increasingly restrictive through the introduction of Targeted Regulation of Abortion Providers (TRAP) laws. These statutes imposed burdensome and often medically unnecessary administrative and structural requirements on facilities, such as mandating that clinics meet the same physical standards as ambulatory surgical centers or requiring physicians to hold local hospital admitting privileges, which effectively forced many clinics to close.
+
+More recently, Texas served as an early case study for the medical and legal impacts of abortion prohibition through the implementation of Senate Bill 8 (SB 8) in September 2021. SB 8 banned abortion after the detection of embryonic cardiac activity at approximately 6 weeks of gestation and employed a novel private civil enforcement mechanism that allowed any individual to sue those who “aid or abet” an abortion. Because SB 8 effectively ended most abortion access in the state nearly 10 months before the 2022 Supreme Court ruling in Dobbs v. Jackson Women′s Health Organization, it provided a preliminary window into the “chilling effect” on medical practice and residency training. Crucially, the Dobbs decision did not itself ban abortion; rather, it eliminated the federal constitutional protection for the procedure and returned full regulatory authority to the states. This jurisdictional shift occurred alongside a growing population of people who can become pregnant and an intensifying shortage of OBGYN providers [3].
+
+The mediated effects of these subsequent state‐level restrictions have created significant hurdles for medical education. Although the Accreditation Council for Graduate Medical Education (ACGME) requires all OBGYN residency programs to provide access to abortion training, nearly half of all residents now train in states with restrictive laws [4]. In these jurisdictions, residents must often travel out of state to meet clinical requirements, incurring substantial financial and logistical burdens. Furthermore, a survey of third‐ and fourth‐year medical students conducted shortly after the Dobbs ruling found that 76.9% of respondents reported that changes in abortion access would influence their choice of residency specialty and geographic location [5].
+
+Current data supports these concerns; a 2024 cross‐sectional study revealed a significant decrease in residency applications to programs in states with the strictest abortion laws [4]. Given that the majority of designated “maternity care deserts” are already located in restrictive states, the ongoing decline in applicants may further shrink the provider workforce and worsen maternal health outcomes [6]. The purpose of this literature review is to examine how the post‐Dobbs regulatory landscape has influenced residency training preferences and how these shifts contribute to burgeoning healthcare disparities for patients residing in underserved areas.
+
+2. Methods
+
+This narrative review is aimed at synthesizing current evidence on how abortion policy changes affect medical education and the OBGYN workforce. The authors conducted a systematic search of the PubMed/MEDLINE, Scopus, and Google Scholar databases to identify relevant peer‐reviewed studies. The search strategy utilized combinations of MeSH terms and keywords, including: “Dobbs v. Jackson,” “medical residency applications,” “OBGYN training,” “abortion restrictions,” and “maternal health equity.”
+
+The search was conducted throughout February 2025 and concluded on March 1, 2025. To ensure relevance to the current sociopolitical and legal climate, studies were eligible for inclusion if they were published in or after 2020. Exclusion criteria included studies not available in English, those focusing solely on international healthcare systems without a US comparison, and commentaries or editorials that did not present original data or systematic syntheses. Grey literature, including policy briefs from the Guttmacher Institute and the Association of American Medical Colleges (AAMC) reports, was systematically included to capture emerging data in this rapidly evolving landscape.
+
+The screening process was managed using Covidence, a web‐based tool for systematic reviews. The first three authors independently screened titles and abstracts, followed by a full‐text review to ensure organization and minimize selection bias. Each reviewer worked through the references separately and remained blinded to the votes of the other two reviewers during the initial screening phase; discrepancies were resolved through consensus. Following this process, 14 studies remained eligible for analysis. Data and key findings, including study design, geographic focus, and primary outcomes, were systematically extracted and synthesized for this review.
+
+3. Results
+
+3.1. Influence of Abortion Restrictions on Residency Program Selection and Practice Locations
+
+Dobbs v. Jackson Women′s Health Organization has impacted future and current physicians in all specialties in several ways. Laws regarding abortion access impact where medical students and residents choose to complete their training to become physicians, the education and training they receive, and how and where they choose to practice once they are trained physicians. Medical students have some freedom to choose where they complete their residency training to become physicians, along with which specialty they want to train in. Between 6 August and 22 October 2022, third‐year and fourth‐year US medical students applying to US residency programs were surveyed by Traub et al. to examine how Dobbs is influencing the ideological, personal, and professional factors they must reconcile when choosing where and how to complete residency. Medical students entering residency, especially those who can become pregnant, recognize that their existing lack of autonomy may be exacerbated by changes in access to reproductive healthcare. Respondents in this study highlighted Dobbs as a major factor impacting their decision on where to apply for residency, indicating the significant influence abortion access is having on where the next generation of physicians will be training. The respondents applying only to programs in states with abortion restrictions predominantly identified as Catholic and cisgender male [7]. Although this survey reflects the opinions of medical students applying to any specialty, the trend in those students applying to OBGYN residency programs demonstrated a clear shift in geographic distribution in the year following abortion access changes. Hammoud et al. conducted a comprehensive review examining the impact of the Dobbs v. Jackson Women′s Health Organization on healthcare providers and medical training and found that although overall applicant numbers remained stable between 2019 and 2023, the distribution of applicants differed significantly by state abortion ban status in the 2022 and 2023 match cycles when comparing data from 2019 through 2023. There was a 15% decrease in OBGYN residency applications in restrictive states post‐Dobbs, as 44% of residency programs in restrictive states now have limited access to abortion training. Eighty‐two percent of students preferred states with fewer restrictions for training, which may contribute to shifts in workforce distribution in the future [4].
+
+Woodcock et al. also examined how restrictions may affect OBGYN residents′ plans after graduation and their transition to practice. Their mixed‐methods study surveyed graduates from programs affiliated with the Kenneth J. Ryan Residency Training Program in Abortion and Family Planning, a national initiative founded in 1999 to help residency programs meet ACGME requirements for opt‐out family planning and abortion training. By focusing on these 109 Ryan Program sites between March and April 2023, the researchers captured the perspectives of trainees specifically prepared for comprehensive reproductive care. Regardless of their training site, 17.6% of these residents changed their intended practice location after the Dobbs decision, a shift directly linked to state‐level abortion restrictions and personal access to care. Residents who had originally intended to practice in restrictive states were 8.52 times more likely to change their future location post‐Dobbs, with 82.0% expressing strong advocacy for abortion access. Furthermore, only 33.4% maintained plans to work in restrictive jurisdictions. This trend extended into subspecialty training; many residents ranked fellowship programs in restricted states lower or avoided applying altogether, particularly in fields like reproductive endocrinology [8]. Thus, the post‐Dobbs regulatory environment has not only influenced initial residency selection but has created a provisional trend of workforce redistribution as newly trained physicians, specifically those from Ryan Program‐affiliated institutions, opt to establish their practices in states with fewer legal constraints.
+
+Dobbs also influences the type of training that medical students and residents receive during their education. Before the 2022 ruling, Vinekar et al. predicted that 44.8% of accredited OBGYN residency programs were in states that were certain or likely to ban abortion if Roe v. Wade was overturned, thus impacting residency training. They also predicted 43.9% of the 2022 OBGYN residents were projected to lack access to in‐state abortion training, highlighting significant potential challenges for future training and workforce development in the field [9]. Following the overturning of Roe v. Wade, these projections largely materialized. Beasley et al. found that in 2024, 17% of medical schools do not offer formal abortion education, and only 44% provide clinical training, reducing the number of trained providers. Only 64% of OBGYN residency programs offer dedicated abortion training, with many facing state and institutional barriers. Even with specialized fellowship programs, physicians still face significant barriers to providing abortion care, especially in restrictive states. Nearly 50% of OBGYN residency programs and 40% of residents are now in states that have banned or restricted abortion access, which complicates training for abortion care. Programs in restricted states are coordinating with programs in protected states for abortion training, but logistical and legal challenges are increasing, requiring careful coordination for out‐of‐state rotations [10]. Additionally, for medical students applying to OBGYN residency programs, it is difficult to even find this information about abortion training. In a 2024 study, Karlapudi et al. aimed to characterize public info on abortion training in OBGYN residency programs in states with and without bans. After a systematic internet search of every program′s website to identify info on abortion training, it was found that two‐thirds of OBGYN residency programs provide public information about abortion training, but half of the programs in abortion‐restricted states do not. Residency programs in states with legal abortion are more likely to offer publicly available information and Ryan Program affiliation. Many programs avoid using the term “abortion” and instead refer to “family planning” when describing training, making it unclear if abortion training is included. Applicants may struggle to identify programs offering abortion training, especially in restrictive states, underscoring the need for greater transparency [11]. The training received by OBGYN residents in all states has been significantly impacted by the Dobbs ruling and subsequent state‐level legal responses. These current disruptions to training may have longer‐term effects on physician education and workforce distribution if they persist over time.
+
+Finally, for both newly trained and practicing attending physicians, the post‐Dobbs regulatory environment has significantly impacted how they practice medicine and, subsequently, how patient care has been affected, and this goes well beyond just the field of OBGYN. Roper et al. added 10 questions to the 2022 Council of Academic Family Medicine Educational Research Alliance general membership survey to evaluate the impact on relevant themes in reproductive health care and training after the Dobbs decision. Responses were categorized by the severity of restriction of state abortion policies. The 991 respondents with clinical responsibilities (82% of the total respondents) reported significant changes in their counseling practices, clinical decision making, worry of legal risks, and trust in patients′ self‐reported reproductive medical history, compared with peers in protective states. Respondents in restrictive states also reported decreased confidence in family medicine residency programs and perceived them as less desirable [12]. Brindis et al. examined how Dobbs impacted the entire national medical workforce. Impacts vary across states, but providers in states with restrictive abortion laws now must contend with evolving legal and ethical challenges that have the potential to affect physicians through workforce safety, mental health, education, and training opportunities. Additionally, some state abortion laws may conflict with federal statutes such as the Emergency Medical Treatment and Active Labor Act (EMTALA), exposing providers to legal uncertainty and potential penalties. The Dobbs decision may increase burnout and moral distress among providers, particularly those in restrictive states, further affecting residency applications, training opportunities, and long‐term workforce trends [13]. These effects extend beyond medical trainees and decisions on where to practice, but also to the currently established physicians in all states.
+
+3.2. Persistent Gaps in Reproductive Healthcare and Their Impact on Access, Equity, and Maternal Health Outcomes
+
+The American College of Obstetricians and Gynecologists (ACOG) has consistently emphasized that legislative restrictions on abortion services interfere with the patient–health care professional relationship and disproportionately affect individuals with low incomes and those residing in underserved areas [14]. This aligns with the Zhu et al. scoping review of 54 studies, which found that post‐Dobbs abortion bans have led to clinic closures and forced patients to travel over 400 mi for care. These increased travel distances serve as a primary mechanical barrier to equity, as the associated financial and logistical burdens fall most heavily on marginalized populations. Additionally, the study noted a 21% increase in demand for permanent contraception in restrictive states and heightened concerns among medical trainees regarding legal risks, contributing to potential provider shortages. The review underscores how these restrictions exacerbate inequities in maternal healthcare access and outcomes, particularly in areas already facing provider shortages and limited healthcare infrastructure [15].
+
+Further supporting these concerns, a 2024 study by Morin et al. investigates the impact of restrictive abortion laws on the OBGYN workforce in Texas, revealing that the attrition of providers directly correlates with longer wait times for prenatal services and reduced access to emergency obstetric care. This study highlights that Black and Indigenous patients, who already navigate a healthcare system with a baseline of higher maternal mortality, are uniquely vulnerable to these workforce shifts. Specifically, the relocation of OBGYNs from restrictive jurisdictions removes the last line of defense for patients experiencing high‐risk complications such as preeclampsia or postpartum hemorrhage. For these populations, the loss of a local provider does not just mean a longer commute; it often results in the total absence of life‐saving intervention during crucial hours of obstetric emergencies [16].
+
+Kheyfets et al. examine how restrictive abortion laws contribute to the worsening maternal mortality crisis in the United States, particularly in states where the legal environment restricts clinical education. Their analysis reveals that states with more restrictive abortion policies tend to have significantly higher maternal mortality rates, with Black pregnant individuals facing the greatest disparities due to systemic barriers and reduced access to care. States with the most restrictive policies report significantly higher maternal mortality rates, with Black pregnant individuals facing the greatest disparities. This is not merely a geographic coincidence but a mediated outcome of systemic barriers. As providers leave or limit their practice due to legal uncertainty, the density of skilled clinicians capable of managing complex pregnancies thins, leaving marginalized patients to rely on overextended emergency departments that may lack specialized obstetric expertise. Additionally, the authors highlight the role of misinformation and lack of abortion education in worsening health outcomes, emphasizing the urgent need for policy reforms to address these inequities and improve maternal health [17].
+
+Wallace et al. further elucidate the challenges faced in regions with limited access to maternity care, even before the overturning of Roe v. Wade. Analyzing data from Louisiana, the researchers found that certain Louisiana parishes lacking adequate maternal health services experienced significantly higher rates of pregnancy‐associated mortality. This correlation underscores the compounded risks in regions where restrictive abortion laws coincide with insufficient healthcare infrastructure, leading to poorer maternal health outcomes [6]. These restrictions also exacerbate provider shortages, a concern further highlighted by Mermin‐Bunnell et al., who found that medical students are increasingly deterred from applying to residency programs in states with abortion bans. This shift threatens to deepen existing gaps in reproductive healthcare by reducing the number of trained providers in states already facing critical shortages. By discouraging new physicians from entering the pipeline in restrictive jurisdictions, these policies have the potential to create a structural deficit in the workforce, and the geographic and racial gaps in maternal health outcomes may continue to widen as the next generation of providers clusters in states with greater reproductive freedoms. As fewer physicians choose to practice in restrictive states, patients encounter longer wait times, fewer available specialists, and increased financial and logistical burdens when seeking care [5].
+
+4. Discussion
+
+The jurisdictional shift following the Dobbs (2022) decision and the subsequent enactment of restrictive abortion laws in several US states have reshaped the landscape of medical residency applications, physician training, and healthcare access. This literature review synthesizes a growing body of evidence showing that state‐level legislative responses, mediated by the removal of federal constitutional protections, are influencing residency selection and training. These findings are largely consistent with the existing literature on the intersection of healthcare access and law, but the full extent of these implications remains to be seen.
+
+The studies reviewed reveal several clear trends: firstly, restrictive state laws, rather than the Dobbs ruling in isolation, have influenced medical students′ decisions regarding where to train. Following the implementation of state‐level bans enabled by Dobbs, there has been a notable decline in residency applications to programs in those jurisdictions. This aligns with research indicating students increasingly consider local legal environments when choosing training sites. Studies by Hammoud et al. and Woodcock et al. further suggest residents in restrictive regulatory environments may be more likely to change their practice location after graduation. These shifts appear linked to statutory constraints governing clinical practice rather than to the Court decision alone.
+
+A strength of this review lies in its mapping of diverse study designs. However, a primary limitation is the inability to compare long‐term data across eras. The period since Dobbs returned regulatory authority to the states is only 2.5 years old, compared with nearly 50 years of research under the Roe and Casey frameworks. Consequently, the long‐term impacts of this newly fragmented legal landscape on workforce distribution and maternal health remain a subject of active, ongoing study.
+
+The implications for health equity are far‐reaching and extend beyond the physician workforce. The thinning of the OBGYN pipeline creates a secondary “ripple effect” that disrupts the entire multidisciplinary care team, including genetic counselors, social workers, and labor‐and‐delivery nursing staff. In restrictive jurisdictions, these providers often face similar ethical dilemmas and legal uncertainties when navigating complex fetal diagnoses or social support for patients requiring out‐of‐state travel. This systemic erosion of the specialized workforce, where the loss of an OBGYN often leads to the underutilization or relocation of affiliated support staff, further exacerbates disparities in maternal health outcomes. For Black and Indigenous patients, the loss of these culturally competent navigators is particularly devastating, as these providers are often the primary link between the patient and the increasingly fragmented healthcare infrastructure. Additionally, state‐specific restrictions may contribute to provider shortages, especially in rural areas. This pattern underscores how the varied legislative landscape post‐Dobbs may further entrench geographic disparities in health outcomes.
+
+5. Conclusion
+
+The Dobbs v. Jackson (2022) ruling, which returned abortion jurisdiction to state legislatures, has profound implications for the future of the medical workforce. This review underscores the impact of post‐Dobbs state laws on OBGYN residency applications and physician retention. As discussed, recent data demonstrate a decline in applications in states with near‐total bans; for example, Texas reported a 16% decline in applications following the implementation of state‐level restrictions. Additionally, provider shortages are exacerbated by physicians opting to leave these restrictive jurisdictions or forgoing obstetrics to avoid legal uncertainty. Although the Dobbs decision served as the legal catalyst, the primary drivers of these shifts are the heterogeneous state‐level regulations that followed. Given the limited 2.5‐year data set, continued longitudinal research is necessary to track whether these mediated workforce trends will lead to lasting changes in the geographic distribution of OBGYN providers.
+
+Author Contributions
+
+Brooke Gully and Ellie Whitney are contributing first authors.
+
+Funding
+
+No funding was received for this manuscript.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Data Availability Statement
+
+Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.
+
+
+1 Planned Parenthood Action Fund , Historical Abortion Law Timeline: 1850 to Today, Planned Parenthood Action Fund, https://www.plannedparenthoodaction.org/issues/abortion/abortion-central-history-reproductive-health-care-america/historical-abortion-law-timeline-1850-today.
+2 Gold R. B. , Lessons From Before Roe: Will Past be Prologue?, 2003, Guttmacher Institute, https://www.guttmacher.org/gpr/2003/03/lessons-roe-will-past-be-prologue.12807128
+3 Stonehocker J. , Muruthi J. , and Rayburn W. F. , Is There a Shortage of Obstetrician-Gynecologists?, Obstetrics and Gynecology Clinics of North America. (2017) 44, no. 1, 121–132, 10.1016/j.ogc.2016.11.006, 28160889.28160889
+4 Hammoud M. M. , Morgan H. K. , George K. , Ollendorff A. T. , Dalrymple J. L. , Dunleavy D. , Zhu M. , Banks E. , Akingbola B. A. , and Connolly A. M. , Trends in Obstetrics and Gynecology Residency Applications in the Year After Abortion Access Changes, JAMA Network Open. (2024) 7, no. 2, e2355017, 10.1001/jamanetworkopen.2023.55017, 38324311.38324311 PMC10851098
+5 Mermin-Bunnell K. , Traub A. M. , Wang K. , Aaron B. , King L. P. , and Kawwass J. , Abortion Restrictions and Medical Residency Applications, Journal of Medical Ethics. (2025) 51, no. 2, 79–86, 10.1136/jme-2023-109190, 38071579.38071579
+6 Wallace M. , Dyer L. , Felker-Kantor E. , Dyer L. , Felker-Kantor E. , Benno J. , Vilda D. , Harville E. , and Theall K. , Maternity Care Deserts and Pregnancy-Associated Mortality in Louisiana, Women’s Health Issues. (2021) 31, no. 2, 122–129, 10.1016/j.whi.2020.09.6.33069560 PMC8005403
+7 Traub A. M. , Mermin-Bunnell K. , Wang K. , Aaron B. , King L. P. , and Kawwass J. F. , How Dobbs May Influence the Geographic Distribution of Medical Trainees in the United States, Health Education & Behavior. (2024) 52, 242–246, 10.1177/10901981241292280.39462292
+8 Woodcock A. L. , Carter G. , Baayd J. , Turok D. K. , Turk J. , Sanders J. N. , Pangasa M. , Gawron L. M. , and Kaiser J. E. , Effects of the Dobbs v Jackson Women′s Health Organization Decision on Obstetrics and Gynecology Graduating Residents′ Practice Plans, Obstetrics and Gynecology. (2023) 142, no. 5, 1105–1111, 10.1097/AOG.0000000000005383.37769302
+9 Vinekar K. , Karlapudi A. , Nathan L. , Turk J. K. , Rible R. , and Steinauer J. , Projected Implications of Overturning Roe v Wade on Abortion Training in U.S. Obstetrics and Gynecology Residency Programs, Obstetrics and Gynecology. (2022) 140, no. 2, 146–149, 10.1097/AOG.0000000000004832.35852261
+10 Beasley A. D. , Olatunde A. , Cahill E. P. , and Shaw K. A. , New Gaps and Urgent Needs in Graduate Medical Education and Training in Abortion, Academic Medicine. (2023) 98, no. 4, 436–439, 10.1097/ACM.0000000000005154.36656271
+11 Karlapudi A. , Rible R. , and Vinekar K. , Transparency Around Abortion Training on Obstetrics and Gynecology Residency Program Websites, Contraception. (2024) 130, 110296, 10.1016/j.contraception.2023.110296.37739304
+12 Roper K. L. , Robbins S. J. , Day P. , Shih G. , and Kale N. , Impact of State Abortion Policies on Family Medicine Practice and Training After Dobbs v Jackson Women′s Health Organization, Annals of Family Medicine. (2024) 22, no. 6, 492–501, 10.1370/afm.3183, 39586689.39586689 PMC11588381
+13 Brindis C. D. , Laitner M. H. , Clayton E. W. , Scrimshaw S. C. , Grosz B. J. , Simpson L. A. , Rosenbaum S. , Brierley C. L. , Simon M. A. , Roubideaux Y. , Calonge B. N. , Johnson P. A. , DeStefano L. , Bear A. , Arora K. S. , and Dzau V. J. , Health-Care Workforce Implications of the Dobbs v Jackson Women′s Health Organization Decision, Lancet. (2024) 403, no. 10445, 2747–2750, 10.1016/S0140-6736(24)00581-6.38795713
+14 American College of Obstetricians and Gynecologists′ Committee on Health Care for Underserved Women, American College of Obstetricians and Gynecologists′ Abortion Access and Training Expert Work Group , Increasing Access to Abortion: ACOG Committee Opinion, Number 815, Obstetrics and Gynecology. (2020) 136, no. 6, e107–e115, 10.1097/AOG.0000000000004176.33214531
+15 Zhu D. T. , Zhao L. , Alzoubi T. , Shenin N. , Baskaran T. , Tikhonov J. , and Wang C. , Public Health and Clinical Implications of Dobbs v. Jackson for Patients and Healthcare Providers: A Scoping Review, PLoS One. (2024) 19, no. 3, e0288947, 10.1371/journal.pone.0288947, 38551970.38551970 PMC10980209
+16 Morin A. , Bachrach D. , Fox A. , Kirch D. , Madubuonwu J. , and Health M , The Texas OB/GYN Physician Workforce Early Assessment of the Impact of Abortion Restrictions on the Workforce Pipeline, 2024, https://assets-us-01.kc-usercontent.com/9fd8e81d-74db-00ef-d0b1-5d17c12fdda9/34392fc8-1c9a-48a2-be8f-3f79d8a4a7d5/FINAL-TX-OBGYN-Workforce-Study_2024-10_f.pdf.
+17 Kheyfets A. , Dhaurali S. , Feyock P. , Khan F. , Lockley A. , Miller B. , Cohen L. , Anwar E. , and Amutah-Onukagha N. , Corrigendum: The Impact of Hostile Abortion Legislation on the United States Maternal Mortality Crisis: A Call for Increased Abortion Education, Frontiers in Public Health. (2024) 12, 1358617, 10.3389/fpubh.2024.1358617, 38371242.38371242 PMC10870982
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Oncol
+Journal ID: Front Oncol
+NLM Journal ID: 101568867
+Journal ID: Front. Oncol.
+
+Frontiers in Oncology
+
+EISSN: 2234-943X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13054803
+PMID: 41952680
+DOI: 10.3389/fonc.2026.1803643
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Recent therapeutic advances in gynecologic oncology: evolving roles of immunotherapy, antibody–drug conjugates, and clinical trial innovations
+
+Koshkimbayeva Gaukhar 1 Conceptualization Methodology Visualization Writing – original draft Writing – review & editing
+Amirkhanova Akerke 2 * Conceptualization Methodology Project administration Resources Supervision Visualization Writing – original draft Writing – review & editing
+Orazymbetova Aiken 3 Funding acquisition Methodology Software Writing – original draft
+Nurakhova Alma 4 * Conceptualization Funding acquisition Methodology Validation Writing – review & editing
+Maimakova Akmaral 5 Conceptualization Methodology Supervision Visualization Writing – original draft
+Duisenbayeva Altyn 6 Formal analysis Funding acquisition Methodology Writing – review & editing
+Akhmad Nurgulim 7 Formal analysis Writing – original draft
+Abilova Altyn 7 Funding acquisition Methodology Writing – review & editing
+Abilbayeva Arailym 8 Conceptualization Investigation Methodology Writing – original draft
+Akhelova Sholpan 9 Methodology Writing – original draft Writing – review & editing
+Akhmentayeva Dana 10 Funding acquisition Methodology Writing – review & editing
+Seitaliyeva Aida 11 * Conceptualization Methodology Supervision Writing – original draft Writing – review & editing
+Dushimova Zaure 11 Methodology Writing – review & editing
+Shynykul Zhanserik 11 Conceptualization Methodology Writing – original draft
+Yerkenova Sandugash 12 Conceptualization Methodology Writing – review & editing
+1 Department of General Medical Practice with Courses, Kazakh-Russian Medical University , Almaty ,  Kazakhstan
+2 School of Pharmacy, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+3 Department of Anatomy with Courses, Kazakh-Russian Medical University , Almaty ,  Kazakhstan
+4 Department of Normal Physiology with a course in Biophysics, School of Medicine, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+5 Clinical Medicine Department of International Business, University named after Kenzhegali Sagadiev , Almaty ,  Kazakhstan
+6 Department of Anatomy named after S. R. Karynbayev, School of General Medicine 1, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+7 General Immunology Department, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+8 General Immunology Department, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+9 Department of Pharmaceutical Disciplines, NCJSC “Astana Medical University” , Astana ,  Kazakhstan
+10 Department of Internal Medicine, S.D. Asfendiyarov Kazakh National Medical University , Almaty ,  Kazakhstan
+11 Faculty of Medicine and Healthcare, Al-Farabi Kazakh National University , Almaty ,  Kazakhstan
+12 Department of Anatomy, Kazakhstan’s Medical University “KSPH” , Almaty ,  Kazakhstan
+* Correspondence: Akerke Amirkhanova, amirhanova.a@kaznmu.kz; Aida Seitaliyeva, seitaliyeva.aida@med-kaznu.com; Alma Nurakhova, nurakhova.a@kaznmu.kz
+Electronic publication date: 2026 Mar 24
+Publication date: 2026
+Volume: 16
+Electronic Location ID: 1803643
+Received 2026 Feb 4; Accepted 2026 Feb 19
+Copyright: Copyright © 2026 Koshkimbayeva, Amirkhanova, Orazymbetova, Nurakhova, Maimakova, Duisenbayeva, Akhmad, Abilova, Abilbayeva, Akhelova, Akhmentayeva, Seitaliyeva, Dushimova, Shynykul and Yerkenova.
+Copyright year: 2026
+Copyright holder: Koshkimbayeva, Amirkhanova, Orazymbetova, Nurakhova, Maimakova, Duisenbayeva, Akhmad, Abilova, Abilbayeva, Akhelova, Akhmentayeva, Seitaliyeva, Dushimova, Shynykul and Yerkenova
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Recent therapeutic advances in gynecologic oncology: evolving roles of immunotherapy, antibody–drug conjugates, and clinical trial innovations 15 15 1 2026 1697180 Frontiers in Oncology 10.3389/fonc.2025.1697180 PMC12851983 41626151
+Keywords: gynecologic malignancies, immune checkpoint inhibitors, antibody–drug conjugates, ovarian cancer, endometrial cancer, cervical cancer, cancer
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Gynecological Oncology
+
+Ÿ==============================Ÿ
+Affiliation “Department of Anatomy named after S. R. Karynbayev, School of General Medicine 1, S.D. Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan” was erroneously given as an incorrect affiliation for “Nurgulim Akhmad and Altyn Abilova”.
+
+Affiliation “Department of Anatomy with Courses, Kazakh-Russian Medical University, Almaty, Republic of Kazakhstan” was erroneously given as an incorrect affiliation for “Aiken Orazymbetova”.
+
+The original version of this article has been updated.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
diff --git a/corpus/healthcare/text/4527e07e3c5a09e5.txt b/corpus/healthcare/text/4527e07e3c5a09e5.txt
new file mode 100644
index 0000000000000000000000000000000000000000..798f1150ad937d9a1fa2fe9562309e50518743b2
--- /dev/null
+++ b/corpus/healthcare/text/4527e07e3c5a09e5.txt
@@ -0,0 +1,60 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Biomed Sci
+Journal ID: J Biomed Sci
+NLM Journal ID: 9421567
+
+Journal of Biomedical Science
+
+ISSN: 1021-7770
+EISSN: 1423-0127
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13003737
+PMID: 41857635
+DOI: 10.1186/s12929-026-01235-0
+Article ID: 1235
+Article version: 1
+Subjects: Correction
+
+Correction: Decoding collagen cues: the interplay of integrins and discoidin domain receptors in health and disease
+
+Trono Paola paola.trono@cnr.it
+1
+Masi Ilenia 2
+Ottavi Flavia 2
+Rosano Laura laura.rosano@cnr.it
+2
+1 Institute of Biochemistry and Cell Biology (IBBC)-CNR, Via E. Ramarini, 32, 00015 Monterotondo Scalo, Rome, Italy
+2 https://ror.org/01nyatq71 grid.429235.b 0000 0004 1756 3176 Institute of Molecular Biology and Pathology (IBPM)-CNR, Via Degli Apuli 4, 00185 Rome, Italy
+Electronic publication date: 2026 Mar 19
+Publication date: 2026
+Volume: 33
+Electronic Location ID: 32
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Decoding collagen cues: the interplay of integrins and discoidin domain receptors in health and disease 33 6 1 2026 8 Journal of Biomedical Science 10.1186/s12929-025-01211-0 PMC12771863 41492134
+issue-copyright-statement: © National Science Council of the Republic of China (Taiwan) 2026
+
+Ÿ==============================Ÿ
+Correction: Journal of Biomedical Science (2026) 33:8 10.1186/s12929-025-01211-0
+
+After publication of the article [1], it was brought to our attention that the first name and last name of author Flavia Ottavi are reversed. The correct name has been shown in this Correction.
+
+The original article has been updated.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+Reference
+
+1. Trono P Masi I Flavia O Rosano L Decoding collagen cues: the interplay of integrins and discoidin domain receptors in health and disease J Biomed Sci 2026 33 8 10.1186/s12929-025-01211-0 41492134 PMC12771863
+Trono P, Masi I, Flavia O, Rosano L. Decoding collagen cues: the interplay of integrins and discoidin domain receptors in health and disease. J Biomed Sci. 2026;33:8. 10.1186/s12929-025-01211-0.41492134 10.1186/s12929-025-01211-0 PMC12771863
diff --git a/corpus/healthcare/text/45424caa7345e1a3.txt b/corpus/healthcare/text/45424caa7345e1a3.txt
new file mode 100644
index 0000000000000000000000000000000000000000..d422c530e3c04c1574ff9d0099bc925b2ceb3ff2
--- /dev/null
+++ b/corpus/healthcare/text/45424caa7345e1a3.txt
@@ -0,0 +1,55 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Cureus
+Journal ID: Cureus
+NLM Journal ID: 101596737
+Journal ID: Cureus
+
+Cureus
+
+EISSN: 2168-8184
+Publisher: Cureus Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13319495
+PMID: 42388932
+DOI: 10.7759/cureus.c457
+Article version: 1
+Subjects: Correction
+
+Correction: Clinical Implications of Mounjaro (Tirzepatide) for Breast Cancer Detection and Management: A Narrative Review
+
+Correction
+
+Muacevic Alexander
+Adler John R
+Mady Raafat 1
+Tafazal Habib 2
+Soliman Haitham 1
+Ramadan Ayman 3
+Hajaj Mohamed 4
+1 Department of Breast Surgery, Kettering General Hospital, Kettering, GBR
+2 Department of Breast Surgery, Blackrock Clinic, Dublin, IRL
+3 Department of Medical Oncology, Kettering General Hospital, Kettering, GBR
+4 Radiology Department, Breast Cancer Center, American Hospital, Dubai, ARE
+Raafat Mady rafat4u2000@yahoo.com
+Electronic publication date: 2026 Jun 30
+Publication date: 2026 Jun
+Volume: 18
+Issue: 6
+Electronic Location ID: c457
+Copyright: Copyright © 2026, Mady et al.
+Copyright year: 2026
+Copyright holder: Mady et al.
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Clinical Implications of Mounjaro (Tirzepatide) for Breast Cancer Detection and Management: A Narrative Review 18 6 24 6 2026 e111445 Cureus 10.7759/cureus.111445 PMC13319496 42388957
+
+Ÿ==============================Ÿ
+This article has been corrected to change Dr. Mohamed Hajaj’s affiliation to: Radiology Department, Breast Cancer Center, American Hospital, Dubai, UAE.
+
+No competing interests declared.
+
diff --git a/corpus/healthcare/text/4553f3075b571503.txt b/corpus/healthcare/text/4553f3075b571503.txt
new file mode 100644
index 0000000000000000000000000000000000000000..af299f36155b72486df90d276ac74a0bed2865b1
--- /dev/null
+++ b/corpus/healthcare/text/4553f3075b571503.txt
@@ -0,0 +1,315 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: JMIR Res Protoc
+Journal ID: JMIR Res Protoc
+NLM Journal ID: 101599504
+Journal ID: ResProt
+
+JMIR Research Protocols
+
+EISSN: 1929-0748
+Publisher: JMIR Publications Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11462133
+PMID: 39316796
+DOI: 10.2196/58845
+Article ID: v13i1e58845
+Article version: 1
+Subjects: Protocol, Protocol
+
+Self-Management Systems for Patients and Clinicians in Parkinson Care: Protocol for an Integrated Scoping Review, Product Search, and Evaluation
+
+Leung Tiffany
+Zwicker Jocelyn Christine
+Mehdizadeh Hamed
+Boege Selina BSc, MA 1 2 https://orcid.org/0009-0001-7981-348X
+Milne-Ives Madison BAS, MSc 1 2 https://orcid.org/0000-0001-7628-882X
+Meinert Edward MA, MSc, MBA, MPA, MPH, CEng, EUR ING, PhD https://orcid.org/0000-0003-2484-3347 1 2 3 Translational and Clinical Research Institute Faculty of Medical Sciences Newcastle University Framlington Place Newcastle upon Tyne, NE2 4HH United Kingdom 44 0191 208 6000 e.meinert14@imperial.ac.uk
+
+Carroll Camille PhD 1 2 4 https://orcid.org/0000-0001-7472-953X
+1 Translational and Clinical Research Institute Faculty of Medical Sciences Newcastle University Newcastle upon Tyne United Kingdom
+2 Centre for Health Technology University of Plymouth Plymouth United Kingdom
+3 Department of Primary Care and Public Health School of Public Health Imperial College London United Kingdom
+4 University Hospitals Plymouth NHS Trust Plymouth United Kingdom
+Corresponding Author: Edward Meinert e.meinert14@imperial.ac.uk
+Publication date: 2024
+Electronic publication date: 2024 Sep 24
+Volume: 13
+Electronic Location ID: e58845
+Received 2024 Mar 26; Revision requested 2024 Jul 24; Revised 2024 Jul 31; Accepted 2024 Aug 1
+Copyright: ©Selina Boege, Madison Milne-Ives, Edward Meinert, Camille Carroll. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.09.2024.
+Copyright year: 2024
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Parkinson’s disease, digital health, self-management, health care systems, self-care, Parkinson, mobile health, mHeath, evaluation, acceptability, usability, decision-making support, database, qualitative, quantitative, mixed method, perception
+
+Ÿ==============================Ÿ
+Background
+
+Parkinson disease (PD) poses emotional and financial challenges to patients, families, caregivers, and health care systems. Self-management systems show promise in empowering people with PD and enabling more control over their treatment. The collaborative nature of PD care requires communication between patients and health care professionals. While past reviews explored self-management systems in PD diagnosis and symptom management with a focus on patient portals, there is limited research addressing the interconnectivity of systems catering to the needs of both patients and clinicians. A system’s acceptability and usability for clinicians are pivotal for enabling comprehensive data collection and supporting clinical decision-making, which can enhance patient care and treatment outcomes.
+
+Objective
+
+This review study aims to assess PD self-management systems that include a clinician portal and to determine which features enhance acceptability and usability for clinicians. The primary aim is to assess evidence of clinicians’ acceptability and usability of self-management systems with a focus on the integration of systems into clinical workflows, data collection points, monitoring, clinical decision-making support, and extended education and training.
+
+Methods
+
+The review will entail 3 separate stages: a literature review following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, a product search, and an evaluation of the level of evidence for the identified products. For the first stage, 5 databases will be searched: PubMed, CINAHL, Scopus, ACM digital library, and IEEE Xplore. Studies eligible for inclusion will be qualitative, quantitative, and mixed methods studies examining patients’ and clinician’s perceptions of the acceptability and usability of digital health interventions, synthesized by a narrative qualitative analysis. A web search in the iOS Apple App Store and Android Google Play Store will identify currently available tools; the level of evidence for these will then be assessed using the Oxford Centre for Evidence-Based Medicine guidelines.
+
+Results
+
+Literature search and screening began soon after submission of the protocol, and the review is expected to be completed by end of September 2024.
+
+Conclusions
+
+This review will examine currently available self-management systems in PD care, focusing on their acceptability and usability. This is significant because there is limited research addressing the integration of clinicians into these systems. The findings from this study may provide critical knowledge and insight to help inform future research and will contribute to the design of self-management systems that promote collaborative efforts in PD care.
+
+International Registered Report Identifier (IRRID)
+
+PRR1-10.2196/58845
+
+Introduction
+
+Parkinson disease (PD) is a complex and progressive neurological condition with no current cure. It represents the second most common neurodegenerative disorder worldwide [1], with a 30% rise in prevalence and incidence between 2018 and 2030 [2,3]. Clinicians in PD care often have limited data due to infrequent patient contact, constraining their ability to fully inform treatment decisions [4]. The diversity of symptoms experienced by people with PD means that care management is complex. Optimizing symptom management requires an understanding of current symptoms and trends, necessitating thorough communication between patients and clinicians [4,5]. Positive relationships between patients and clinicians can enhance patient trust, medication adherence, and the patients’ active engagement in care, with potential benefits in mitigating health care disparities, fostering interdisciplinary collaboration, and ultimately enhancing patient outcomes [6,7]. Given the strain on health care resources and the limited regular clinical contacts, digital technologies have the potential to help patients self-manage symptoms and provide accurate records of symptoms for clinical review. Despite the availability of such systems, there is limited understanding of how they are adopted, accepted, and used within clinical contexts.
+
+Despite advancements in digital health, many systems still fall short in effectively compiling information for clinician use at the point of care and facilitating seamless care communication [6]. Systems that combine patient self-reporting with clinician management can improve data collection and communication, leading to more efficient care, better decision-making, and ultimately enhanced patient outcomes through more timely and personalized interventions [6], [7]. Previous research has extensively examined engagement with and impact of digital tools in PD care, focusing on self-management methods to enhance physical and cognitive aspects for patients [8-18]. A comprehensive understanding of the acceptance and usability by health care professionals (HCPs) is lacking, leaving room for more inclusive research in PD care [19-28]. There is a need to understand what systems are currently available, how they integrate self-management techniques, and how clinical elements and clinicians are integrated [29-35]. This knowledge gap is particularly crucial to address, as improving clinician engagement with digital tools can lead to more effective and tailored patient care strategies.
+
+This study aims to fill this gap by examining the state of the literature on clinician perspectives of PD self-management systems and the state of clinician-focused features in existing self-management systems. The review will summarize available systems and evidence of their acceptability and usability of self-management systems, while the product evaluation will identify active digital applications, tools, and services (eg, apps, websites, portals, and wearable devices) that support self-management for people with PD to explore what types of technologies are used, which self-management techniques are applied, and how clinicians are integrated.
+
+Methods
+
+Design
+
+This review is structured in 3 distinct stages, each contributing to building a comprehensive overview and understanding of the landscape of self-management systems for PD. We will perform a scoping review by leveraging bibliographic databases, search and select eligible systems on the Apple App store and Google Play store, and evaluate the level of their evidence. Identified self-management systems will be evaluated using the Oxford Centre for Evidence-Based Medicine (OCEBM) guidelines following adherence to established eligibility criteria. Separate analyses will be conducted for the scoping review and product evaluation, as they will extract different types of data, but findings from each will be synthesized in the discussion. The design concludes with a narrative synthesis to summarize study findings and product evaluation results, incorporating study methods, key findings, and outcomes. All review stages are summarized in Table 1.
+
+Table 1 Review stages.
+
+Review stage	Data collection method	Analysis method	
+Stage 1: a scoping review	Search bibliographic databases (PubMed, CINAHL, Scopus, ACM Digital Library, and IEEE Xplore) using PRISMA-ScRa and PICOSb frameworks	Narrative synthesis to identify key themes and gaps	
+Stage 2: product search	Search Apple App Store and Google Play Store using relevant keywords	Evaluation of system characteristics and user feedback	
+Stage 3: data analysis	Extract data from the literature review and product search	Adapt OCEBMc guidelines for system classification and narrative synthesis	
+aPRISMA-ScR: Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
+
+bPICOS: Population, Intervention, Comparator, Outcome, and Studies.
+
+cOCEBM: Oxford Centre for Evidence-Based Medicine.
+
+Search Strategy
+
+Stage 1: Scoping Review
+
+Search
+
+The first stage of the research involves the exploration of existing literature through 5 bibliographic databases: PubMed, CINAHL, Scopus, ACM Digital Library, and IEEE Xplore. The search strategy is designed to identify studies using qualitative, quantitative, and mixed method approaches that investigate HCPs’ perspectives on the acceptability and usability of self-management systems. The PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews; Multimedia Appendix 1) and Population, Intervention, Comparator, Outcome, and Studies (PICOS) frameworks were used to structure the protocol for the review strategy (Table 2) [35]. The PICOS framework was used to outline key themes that shaped the search strategy (Table 3), with themes relating to the population (HCPs), intervention (PD and self-management interventions), and outcomes (evaluation).
+
+The scoping review will be used to systematically chart and synthesize data to identify key themes and gaps in the existing literature, thereby providing a comprehensive overview of this research results and studies to build the foundation for subsequent stages of this research, ensuring that relevant aspects are actual and addressed. The database search will be performed in August 2024 using PubMed (MeSH [Medical Subject Headings] terms), CINAHL (abstract), Scopus (title and abstract), ACM digital library (full text), and IEEE Xplore (full text). A preliminary exploration of identified relevant terms based on the PICOS framework was used to develop the search strategy (Multimedia Appendix 2). The search strategy will include a set of keywords relating to digital self-management tools and their user-friendliness and user acceptance. Keywords were derived from MeSH related to the subject and used as search terms (Table 3).
+
+Table 2 PICOSa framework [35].
+
+PICOS	Detail	
+Population	Health care professionals treating patients
+
+	
+Intervention	Digital interventions for self-management for people with PDb, for example, telehealth, exergaming, websites, smart homes, mobile apps, web-based systems, and wearable devices, which offer a clinician portal or similar which may enable clinical use (eg, e-record integration, messaging features, remote monitoring, or treatment decision support)
+
+	
+Comparator	None
+
+	
+Outcomes	Primary outcome: clinician usability and acceptability of digital interventions for self-management in PD care
+
+‎Secondary outcomes: factors that might impact the usability of these systems including regulatory requirements, training protocols, and any other elements that may influence the overall user experience for both people with PD and clinicians
+
+	
+Study types	Qualitative and quantitative studies, for example, case-control studies, case series, longitudinal studies, cohort studies, or RCTsc
+
+	
+aPICOS: Population, Intervention, Comparator, Outcome, and Studies.
+
+bPD: Parkinson disease.
+
+cRCTs: randomized controlled trials.
+
+Table 3 MeSHa terms and keywords used for literature search.
+
+Category	MeSH terms	Keywords (in title and abstract)	
+Parkinson disease	Parkinson disease OR parkinsonian disorders	“Parkinson’s disease” OR parkinson OR parkinson’s OR “parkinson disease”	
+Health care professional	Physicians OR health personnel	“Healthcare professional” OR “healthcare personnel” OR clinician OR practitioner OR doctor OR nurse OR “care professional”	
+Self-management intervention	Electronic OR technology OR data collection OR internet-based intervention OR digital health OR telemedicine OR computing methodologies OR software OR wearable electronic devices OR self-help devices OR rehabilitation OR computer-user training	“Digital intervention” OR technology OR system OR portal OR remote OR home-based OR database management system OR internet-mediated therapy OR remote consultation OR personal health services	
+Evaluation	Quality of health care OR health care evaluation mechanism OR program evaluation OR attitude OR behaviour OR acceptance process OR acceptance processes OR treatment adherence and compliance OR communication methods, total OR security measures OR educational measurement OR time management OR efficiency, organizational	Evaluation OR attitude OR user experience OR acceptability OR usability OR impact OR acceptance OR compliance OR conformity OR efficiency	
+aMeSH: Medical Subject Headings.
+
+Eligibility
+
+Studies eligible for inclusion are papers that analyze self-management systems for people with PD and their HCP, embed clinical measures, or focus on clinical evidence of acceptability and usability. A comprehensive definition of self-management interventions was used to enable the collection of various intervention types. Any digital form of intervention, whether websites or mobile apps, are considered for inclusion if the system’s intention includes enhancing any aspect of patient self-management in PD. Inclusion criteria for literature encompass published studies at any given time, including randomized controlled trials, cohort studies, and case-control studies. There will be no limit of the publication date as this review aims to have a full overview of available self-management systems for patients with PD.
+
+Studies that do not review or analyze self-management intervention for PD will be excluded as well as editorials, perspective articles, conference papers, and protocols. Literature that is not published in English will be excluded as the research team does not have the necessary resources to assess these.
+
+Screening and Selection of Studies
+
+The selection of studies will be determined by a review of study titles and abstracts in the indexed databases to assess their relevance to the use of digital self-management systems for PD. Selected references will be managed, and duplicates will be eliminated using the citation management software EndNote X21 (Clarivate). The initial screening of these references, based on search strategy keywords, will be conducted through EndNote X21’s search function. A total of 2 authors will screen the title and abstract of each record and will either include or exclude using the eligibility criteria previously described. Once the title and abstract screening is completed, selected records will be obtained for full-text screening. Full-text screening will be undertaken following the eligibility criteria. The stages of the scoping review process and selection of records will be presented using the PRISMA-ScR flowchart [35]. The data extraction and analysis process for this scoping review are described in stage 3.
+
+Stage 2: Product Search
+
+Search
+
+The second stage includes the search and selection of digital interventions currently available in app stores. The process will be executed by searching the Apple App store and Google Play store using relevant keywords to identify and assess digital interventions. The keywords “Parkinson” and “Parkinson’s Disease” will be searched separately on both app stores; all results from each search will be extracted, the lists will be combined, and duplicates will be removed before screening. This stage is designed to encompass a diverse range of self-management tools available that are specific to PD or of potential relevance for patients managing specific symptoms caused by PD. This stage aims to respect the dynamic nature of the systems available for clinicians, ensuring the inclusion of real-world offerings to facilitate a holistic analysis of practical implications for available digital solutions.
+
+Eligibility
+
+Any digital self-management intervention, such as websites, web portals, mobile apps, or wearable devices, will be considered eligible if it primarily focuses on providing self-management services for individuals diagnosed with PD. The system will be designed to operate as a stand-alone product, eliminating the need for the combination of multiple devices. This was chosen to account for operational or financial consequences for the patient in acquiring the system. The system may adopt a paid subscription model, feature in-app purchases, or be offered free of charge to users. Systems included for review must be available in the Apple App store or Google Play store and accessible in English and in the United Kingdom. Eligible apps are any systems for the use of PD self-management. Detailed eligibility criteria are presented in Textbox 1.
+
+Eligibility criteria for systems on app stores included in the study.
+
+Inclusion criteria
+
+Systems available on the UK Apple App store or UK Google Play store
+
+Systems available in English
+
+Systems intended for the self-management of Parkinson disease
+
+Exclusion criteria
+
+Systems not available on the UK Apple App store or UK Google Play store
+
+Systems not available in English
+
+Systems not yet released for public use or access
+
+Screening and Selection of Self-Management Systems
+
+All self-management systems found in the scoping review or product searches will be documented in a Microsoft Excel file, and duplicate entries will be removed. Systems meeting the criteria will be accessed and purchased, if necessary, and downloaded to either the MacOS system or iOS or Android devices. Any systems that, upon closer inspection, do not meet the inclusion criteria will be excluded. In case of disagreements between the reviewers, these will be discussed and, if required, resolved by a third reviewer.
+
+Stage 3: Data Analysis
+
+Data Extraction
+
+Following completion of the screening process and deduplication using EndNote 21 software, eligible studies will be transferred to a Microsoft Excel spreadsheet for further data extraction (Textbox 2). Any modifications to the data extraction items will be recorded contemporaneously and reported in the final review.
+
+Full data charting list.
+
+Literature: system description
+
+Name
+
+Year of launch
+
+Technology domain (eg, internet of things [IoT], mobile app, or website)
+
+Costs
+
+Evaluation method
+
+Type of self-management intervention
+
+Description of self-management intervention
+
+Product evaluation: system characteristics
+
+Intervention outcome or intention
+
+Possibility of data exchange (clinician-patient)
+
+Peer collaboration (clinician-clinician)
+
+Feedback mechanism
+
+Possibility of uploading eHealth records
+
+(Real-time) remote monitoring
+
+Alerts and notifications
+
+Training support
+
+Appointment scheduling
+
+Integration of wearables
+
+Data Analysis
+
+Data extracted from the studies included in the literature review will be analyzed and synthesized narratively. The criteria used to assess the systems found through literature and product searches will be adapted from the OCEBM guidelines [7]. In this categorization, systems will be classified based on the strength of their evidence, ranging from case reports to randomized controlled trial methodology. We will characterize self-management systems described in these reports based on different types of technology, such as mobile apps, websites, web portals, telehealth, digital communication platforms, digital solutions for data management, wearable devices, and web-based training systems. The analytical narrative synthesis of the reviewed literature will examine what self-management techniques are used within the systems and how clinicians are incorporated, investigating if their perspectives are solicited and the degree to which such feedback influences the design and evolution of these digital tools. Systems will be summarized focusing on clinical and operational intention to identify key trends and outcome measures will be examined. The results of this will be tabulated to facilitate visualization of identified systems and their characteristics and elaborated in the discussion of the review. Following the summarization of the findings from the literature review and system selection, the final stage will be a synthesis of qualitative findings from eligible studies combined with information derived from the system search and system descriptions or reviews on the app stores. By categorizing systems based on the technology domain and examining the qualitative data about user experiences, stage 3 aims to synthesize information found; this will enabling a deeper understanding of digital self-management solutions for patients and clinicians in relation to the type and features of the technology, to ensure that the systems not only serve patients but also include integral components in the clinical workflow, thus fostering an efficient and collaborative care environment. The synthesis of qualitative insights with system evaluations will reveal how well current tools support this vital relationship, guiding the development of future solutions to better meet the needs of both patients and HCPs.
+
+Ethical Considerations
+
+There are no ethical considerations for the first stage (scoping review), as this will only examine previously published data. For the stage-2 production evaluation, we will be evaluating intervention features and will not have access to any patient data. The privacy of any user data accessed from app store reviews will be protected through anonymization in the data extraction process.
+
+Results
+
+Literature search and screening began soon after submission of the protocol, and the review is expected to be completed by end of September 2024.
+
+Discussion
+
+This review will examine currently available self-management systems within PD care with a particular focus on their acceptability and usability. The review will adopt a 3-stage approach, involving a scoping review, product search, and evidence of evaluation across various databases.
+
+In the scoping review, there is also a potential publication bias, as the narrative synthesis may rely on published literature that predominantly reports positive outcomes, potentially overlooking negative or inconclusive results. In addition, selection bias could arise from the criteria used to assess and include systems, potentially favoring certain types of technology or studies with more rigorous methodologies. Finally, reporting bias might affect the qualitative synthesis, as the perspectives of clinicians and users reported in app store reviews or system descriptions may not fully capture the range of experiences, particularly those of individuals who did not engage with the tools or had negative experiences. To mitigate these biases, we will include a comprehensive range of studies, apply rigorous inclusion criteria, and seek diverse sources of qualitative data to ensure a balanced and representative analysis. Potential biases in data selection and interpretation may arise from the single-reviewer methodology, which is due to time and resource constraints.
+
+Choosing only the Apple App store and Google Play store can be limiting, especially for health-related apps, as it may exclude specialized or region-specific app stores that offer unique or locally relevant health solutions. In addition, some innovative or niche health apps might only be available on alternative platforms like the Amazon App store, Samsung Galaxy Store, or F-Droid, potentially overlooking valuable resources for comprehensive health management.
+
+The scope of the study will include an examination of the presence and extent of clinician-focused evaluations in existing research but will not deeply synthesize factors affecting clinicians’ acceptability and usability. This is a gap in the literature, but it is not within the scope of this review due to resource and logistical limitations, and the purpose of the scoping review is to provide an overview of the literature. Understanding how to best support clinician adoption and use will be an important factor in the implementation of such systems and a good target for further research.
+
+Despite the limitations, the review is expected to contribute to the literature by addressing a gap in research on the acceptability and usability of self-management systems for clinicians. It will provide a comprehensive summary of self-management systems adopting different types of technology used in PD care and differentiate between patient-centered and clinician-centric tools, aiming to offer recommendations that can inform future system designs.
+
+This review was supported by external funding by Parkinson’s UK Non-Drug Awards Programme (grant NDA-21). Views expressed in this review are those of the authors and are not funding agencies or their affiliated institutions. The review is supported by the National Institute for Health Research (NIHR) Newcastle Biomedical Research Centre (BRC) based at The Newcastle upon Tyne Hospital NHS Foundation Trust; Newcastle University; and the Cumbria, Northumberland and Tyne and Wear (CNTW) NHS Foundation Trust.
+
+Multimedia Appendix 1 PRISMA-ScR (Preferred Reporting Items for Systematic review and Meta-Analysis Extension for Scoping Reviews) 2015 checklist.
+
+Multimedia Appendix 2 Search strings of sample search.
+
+Abbreviations
+
+HCP health care professional
+
+OCEBM Oxford Centre for Evidence-Based Medicine
+
+PD Parkinson disease
+
+PICOS Population, Intervention, Comparator, Outcome, and Studies
+
+PRISMA-ScR Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews
+
+Authors' Contributions: The review protocol was conceived and supervised by MMI and EM. Clinical feedback was provided by CC. SB drafted the protocol, including the research question, Population, Intervention, Comparator, Outcome, and Studies (PICOS), and search strategy. All authors contributed revisions.
+
+Conflicts of Interest: EM is the Editor-in-Chief of JMIRx Med. CC has received advisory, consulting or lecture fees from AbbVie, Bial, Mission Therapeutics, MODAG and Roche, and research funding from Parkinson's UK, Edmond J Safra Foundation, National Institute of Health and Care Research and Cure Parkinson's.
+
+
+1 Kouli A Torsney TM Kuan WL Stoker TB Greenland JC Parkinson’s disease: etiology, neuropathology, and pathogenesis Parkinson’s Disease: Pathogenesis and Clinical Aspects 2018 12 21 Brisbane Codon Publications 3 26 30702842
+2 Kuosmanen E Huusko E van Berkel N Nunes F Vega J Goncalves J Khamis M Esteves A Ferreira D Hosio S Exploring crowdsourced self-care techniques: a study on Parkinson’s disease Int J Hum Comput Stud 2023 09 177 103062 10.1016/j.ijhcs.2023.103062
+3 Bounsall K Milne-Ives M Hall A Carroll C Meinert E Artificial intelligence applications for assessment, monitoring, and management of Parkinson disease symptoms: protocol for a systematic review JMIR Res Protoc 2023 06 14 12 e46581 10.2196/46581 37314853 v12i1e46581 37314853 PMC10337354
+4 Brown EG Schleimer E Bledsoe IO Rowles W Miller NA Sanders SJ Rankin KP Ostrem JL Tanner CM Bove R Enhancing clinical information display to improve patient encounters: human-centered design and evaluation of the Parkinson Disease-BRIDGE platform JMIR Hum Factors 2022 05 06 9 2 e33967 10.2196/33967 35522472 v9i2e33967 35522472 PMC9123539
+5 Hall AM Aroori S Carroll CB Meinert E Allgar V Impact of digital technologies on self-efficacy in people with Parkinson's: a scoping review protocol BMJ Open 2023 03 23 13 3 e069929 10.1136/bmjopen-2022-069929 36958772 bmjopen-2022-069929 PMC10039994 36958772
+6 Dixit S Bohre K Singh Y Himeur Y Mansoor W Atalla S Srinivasan K A comprehensive review on ai-enabled models for Parkinson’s disease diagnosis Electronics 2023 02 04 12 4 783 10.3390/electronics12040783
+7 Freytag J Chu J Hysong SJ Street RL Markham CM Giordano TP Westbrook RA Njue-Marendes S Johnson SR Dang BN Acceptability and feasibility of video-based coaching to enhance clinicians' communication skills with patients BMC Med Educ 2022 02 08 22 1 85 10.1186/s12909-021-02976-2 35135521 10.1186/s12909-021-02976-2 35135521 PMC8822679
+8 Mattison G Canfell O Forrester D Dobbins C Smith D Töyräs Juha Sullivan C The influence of wearables on health care outcomes in chronic disease: systematic review J Med Internet Res 2022 07 01 24 7 e36690 10.2196/36690 35776492 v24i7e36690 35776492 PMC9288104
+9 Triantafyllidis A Segkouli S Zygouris S Michailidou C Avgerinakis K Fappa E Vassiliades S Bougea A Papagiannakis N Katakis I Mathioudis E Sorici A Bajenaru L Tageo V Camonita F Magga-Nteve C Vrochidis S Pedullà L Brichetto G Tsakanikas P Votis K Tzovaras D Mobile app interventions for Parkinson's disease, multiple sclerosis and stroke: a systematic literature review Sensors (Basel) 2023 03 23 23 7 3396 10.3390/s23073396 37050456 s23073396 37050456 PMC10098868
+10 Özden F The effect of mobile application-based rehabilitation in patients with Parkinson's disease: a systematic review and meta-analysis Clin Neurol Neurosurg 2023 02 225 107579 10.1016/j.clineuro.2022.107579 36603336 S0303-8467(22)00460-7 36603336
+11 Marotta N Calafiore D Curci C Lippi L Ammendolia V Ferraro F Invernizzi M de Sire A Integrating virtual reality and exergaming in cognitive rehabilitation of patients with Parkinson disease: a systematic review of randomized controlled trials Eur J Phys Rehabil Med 2022 12 58 6 818 826 10.23736/S1973-9087.22.07643-2 36169933 S1973-9087.22.07643-2 36169933 PMC10081485
+12 Zhang J Luximon Y Pang MYC Wang H Effectiveness of exergaming-based interventions for mobility and balance performance in older adults with Parkinson's disease: systematic review and meta-analysis of randomised controlled trials Age Ageing 2022 08 02 51 8 afac175 10.1093/ageing/afac175 35930726 6653486 35930726
+13 Giannakopoulou KM Roussaki I Demestichas K Internet of things technologies and machine learning methods for Parkinson's disease diagnosis, monitoring and management: a systematic review Sensors (Basel) 2022 02 24 22 5 1799 10.3390/s22051799 35270944 s22051799 35270944 PMC8915040
+14 Tripathi S Malhotra A Qazi M Chou J Wang F Barkan S Hellmers N Henchcliffe C Sarva H Clinical review of smartphone applications in Parkinson's disease Neurologist 2022 07 01 27 4 183 193 10.1097/NRL.0000000000000413 35051970 00127893-202207000-00006 35051970
+15 Gallou-Guyot M Nuic D Mandigout S Compagnat M Welter ML Daviet JC Perrochon A Effectiveness of home-based rehabilitation using active video games on quality of life, cognitive and motor functions in people with Parkinson's disease: a systematic review Disabil Rehabil 2022 12 44 26 8222 8233 10.1080/09638288.2021.2022780 34982599 34982599
+16 Abou L Peters J Wong E Akers R Dossou MS Sosnoff JJ Rice LA Gait and balance assessments using smartphone applications in Parkinson's disease: a systematic review J Med Syst 2021 08 15 45 9 87 10.1007/s10916-021-01760-5 34392429 10.1007/s10916-021-01760-5 34392429 PMC8364438
+17 Ellis TD Earhart GM Digital therapeutics in Parkinson's disease: practical applications and future potential J Parkinsons Dis 2021 11 s1 S95 S101 10.3233/JPD-202407 33646177 JPD202407 33646177 PMC8292155
+18 Morgan C Rolinski M McNaney R Jones B Rochester L Maetzler W Craddock I Whone AL Systematic review looking at the use of technology to measure free-living symptom and activity outcomes in Parkinson's disease in the home or a home-like environment J Parkinsons Dis 2020 10 2 429 454 10.3233/JPD-191781 32250314 JPD191781 32250314 PMC7242826
+19 Hellqvist C Berterö Carina Dizdar N Sund-Levander M Hagell P Self-management education for persons with Parkinson's disease and their care partners: a quasi-experimental case-control study in clinical practice Parkinsons Dis 2020 2020 6920943 10.1155/2020/6920943 10.1155/2020/6920943 32399171 32399171 PMC7210533
+20 Bendig J Spanz A Leidig J Frank A Stahr M Reichmann H Loewenbrück Kai F Falkenburger BH Measuring the usability of eHealth solutions for patients with Parkinson disease: observational study JMIR Form Res 2022 10 25 6 10 e39954 10.2196/39954 36282558 v6i10e39954 36282558 PMC9644252
+21 Owen CL Ibrahim K Dennison L Roberts HC Falls self-management interventions for people with Parkinson's disease: a systematic review J Parkinsons Dis 2019 9 2 283 299 10.3233/JPD-181524 30958315 JPD181524 30958315 PMC6598104
+22 Lökk J Lack of information and access to advanced treatment for Parkinson's disease patients J Multidiscip Healthc 2011 4 433 9 10.2147/JMDH.S27180 22247618 jmdh-4-433 22247618 PMC3256003
+23 So HY Kim SR Kim S Park YS Jo S Park KW Choi N Lee SH Hwang YS Kim MS Chung SJ Effect of home-based self-management intervention for community-dwelling patients with early Parkinson's disease: a feasibility study J Community Health Nurs 2023 40 2 133 146 10.1080/07370016.2022.2133566 36920114 36920114
+24 Guo CC Chiesa PA de Moor C Fazeli MS Schofield T Hofer K Belachew S Scotland A Digital devices for assessing motor functions in mobility-impaired and healthy populations: systematic literature review J Med Internet Res 2022 11 21 24 11 e37683 10.2196/37683 36409538 v24i11e37683 36409538 PMC9723979
+25 Park Y Kim SR So HY Jo S Lee SH Hwang YS Kim MS Chung SJ Effect of mobile health intervention for self-management on self-efficacy, motor and non-motor symptoms, self-management, and quality of life in people with Parkinson's disease: Randomized controlled trial Geriatr Nurs 2022 46 90 97 10.1016/j.gerinurse.2022.05.003 35643018 S0197-4572(22)00116-1 35643018
+26 Klucken J Krüger Rejko Schmidt P Bloem BR Management of Parkinson's disease 20 years from now: towards digital health pathways J Parkinsons Dis 2018 8 s1 S85 S94 10.3233/JPD-181519 30584171 JPD181519 30584171 PMC6311358
+27 Afraie M Moradi G Mohammadzedeh P Azami M Riyahifar S Moradi Y COVID-19 and Parkinson's disease: a systematic review and meta-analysis Acta Neurol Belg 2023 08 123 4 1209 1223 10.1007/s13760-022-02141-6 36385247 10.1007/s13760-022-02141-6 36385247 PMC9668237
+28 Shamseer L Moher D Clarke M Ghersi D Liberati A Petticrew M Shekelle P Stewart LA Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation BMJ 2015 01 02 350 g7647 10.1136/bmj.g7647 25555855 25555855
+29 Nousia A Martzoukou M Tsouris Z Siokas V Aloizou AM Liampas I Nasios G Dardiotis E The beneficial effects of computer-based cognitive training in parkinson's disease: a systematic review Arch Clin Neuropsychol 2020 05 22 35 4 434 447 10.1093/arclin/acz080 31942917 5704023 31942917
+30 Shahhar AZM Qasheesh M Shaphe MA Effectiveness of Nintendo Wii on balance in people with Parkinson's disease: a systematic review J Lifestyle Med 2022 09 30 12 3 105 112 10.15280/jlm.2022.12.3.105 36628175 jlm-12-3-105 36628175 PMC9798876
+31 Garcia-Agundez A Folkerts AK Konrad R Caserman P Tregel T Goosses M Göbel Stefan Kalbe E Recent advances in rehabilitation for Parkinson's disease with exergames: a systematic review J Neuroeng Rehabil 2019 01 29 16 1 17 10.1186/s12984-019-0492-1 30696453 10.1186/s12984-019-0492-1 30696453 PMC6352377
+32 Linares-Del Rey M Vela-Desojo L Cano-de la Cuerda R Mobile phone applications in Parkinson's disease: a systematic review Neurologia (Engl Ed) 2019 34 1 38 54 10.1016/j.nrl.2017.03.006 28549757 S0213-4853(17)30163-9 28549757
+33 Milne-Ives M Carroll C Meinert E Self-management interventions for people with Parkinson disease: scoping review J Med Internet Res 2022 08 05 24 8 e40181 10.2196/40181 35930315 v24i8e40181 35930315 PMC9391969
+34 Spreadbury JH Young A Kipps CM A comprehensive literature search of digital health technology use in neurological conditions: review of digital tools to promote self-management and support J Med Internet Res 2022 07 28 24 7 e31929 10.2196/31929 35900822 v24i7e31929 35900822 PMC9377435
+35 Pigott JS Kane EJ Ambler G Walters K Schrag A Systematic review and meta-analysis of clinical effectiveness of self-management interventions in Parkinson's disease BMC Geriatr 2022 01 11 22 1 45 10.1186/s12877-021-02656-2 35016613 10.1186/s12877-021-02656-2 35016613 PMC8753859
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Public Health
+Journal ID: Front Public Health
+NLM Journal ID: 101616579
+Journal ID: Front. Public Health
+
+Frontiers in Public Health
+
+EISSN: 2296-2565
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13288030
+PMID: 42344263
+DOI: 10.3389/fpubh.2026.1817233
+Article version: 1
+Article version:
+Subjects: Systematic Review
+
+Current status and progress of validation studies on the ICOPE scale: a scoping review
+
+Zhao Yuan 1 Writing – review & editing Writing – original draft
+He Mei 2
+Zhao Songye 3 Visualization Conceptualization Writing – original draft
+Guo Le 1 Methodology Data curation Writing – review & editing Investigation
+Li Gan 3 4 Writing – review & editing Validation
+Tan Ying 1 Writing – review & editing Validation
+Yang Jinjiao 1 Writing – review & editing Resources
+Lan Binghua 1 Writing – review & editing Visualization
+Su Yunpeng 1 * Writing – review & editing
+1 Department of Geriatrics, Dali University , Dali , Yunnan , China
+2 Department of Geriatrics, People’s Hospital of Dali Prefecture , Dali , Yunnan , China
+3 Department of Geriatrics, Affiliated Minzu Hospital, Hubei Minzu University , Enshi , Hubei , China
+4 Department of Health Management, Haiyuan College, Kunming Medical University , Kunming , Yunnan , China
+* Correspondence: Yunpeng Su, 2305989268@qq.com
+Electronic publication date: 2026 Jun 9
+Publication date: 2026
+Volume: 14
+Electronic Location ID: 1817233
+Received 2026 Feb 25; Revised 2026 May 4; Accepted 2026 May 12
+Copyright: Copyright © 2026 Zhao, He, Zhao, Guo, Li, Tan, Yang, Lan and Su.
+Copyright year: 2026
+Copyright holder: Zhao, He, Zhao, Guo, Li, Tan, Yang, Lan and Su
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: healthy aging, intrinsic capacity, older adults, screening tool, validation studies
+
+Funding: The author(s) declared that financial support was not received for this work and/or its publication.
+
+Figure count: 2
+Table count: 1
+Equation count: 0
+Reference count: 41
+Page count: 11
+
+section-at-acceptance: Aging and Public Health
+
+Ÿ==============================Ÿ
+Background
+
+With the rapid global population aging, systematically and early identifying and managing functional decline in older adults has become a core challenge in public health. The Integrated Care for Older People (ICOPE) framework and its screening tool, proposed by the World Health Organization (WHO), aim to prevent disability by assessing intrinsic capacity. However, there is a lack of systematic review of the implementation strategies, effects, and challenges of this tool in different global contexts. This study aimed to review the global implementation evidence of the ICOPE screening tool, analyze its integration paths and influencing factors, and provide a basis for constructing an integrated care model suitable for different resource environments.
+
+Methods
+
+This study systematically retrieved and included literatures meeting the criteria, and comprehensively sorted and conducted comparative analyses of the design, population, positive screening rate, tool performance indicators (such as sensitivity and specificity), and implementation challenges of the included studies.
+
+Results
+
+The study demonstrated significant heterogeneity in the global application of the ICOPE screening tool. The positive screening rates vary greatly due to differences in research design, target populations, and assessment criteria. The psychometric properties of the tool differ across various cultural backgrounds, and the implementation process faces common challenges such as disconnection between screening and intervention, uneven accessibility of digital tools, lack of evidence for long-term effects, and absence of unified diagnostic criteria.
+
+Conclusion
+
+The ICOPE framework shows preliminary feasibility and global acceptance, but the performance of the screening tools needs to be interpreted in the context of specific cultures and populations. Future research should focus on unifying core measurement indicators, conducting long-term validity verification, and establishing a standardized implementation path integrating screening, assessment, and intervention to promote effective implementation of this strategy globally, especially in resource-limited areas.
+
+Highlights
+
+The effectiveness of the ICOPE screening tool varies significantly across regions in global applications.
+
+The distribution patterns of intrinsic capacity decline domains in older adults differ by region.
+
+The reliability and validity of the tool vary across different cultural backgrounds.
+
+The current implementation faces core challenges, such as disconnection between screening and intervention and lack of long-term evidence.
+
+Standardized assessment and integration pathways need to be established to achieve effective promotion.
+
+1 Introduction
+
+The world is aging quickly, and safeguarding the health and quality of life of older adults is a key area of concern in international public health. According to the World Health Organization (WHO), the global older population may increase from 1 billion in 2019 to 2.1 billion in 2050. In this context, a decline in intrinsic capacity(IC) (1) is known to contribute to higher rates of functional decline, hospitalization, and mortality risk among older adults. This situation has created a need for early detection and systematic interventions in the community (2). The traditional “disease-centered” model of health services is unable to meet the diverse and complex needs of older adults (3). WHO has established a framework of integrated care for older adults to support healthy aging. The framework aimed to sustain and improve IC and foster environments that are friendly toward older adults (4). The implementation of the framework depends upon a standardized screening tool, such as the integrated care for older people (ICOPE) screening tool. The tool is subjected to practical studies in countries, such as India, China, Brazil, Singapore, and France, to assess the practicality and initial effects in different sociocultural set-ups. A global “gold standard” to evaluate ICOPE has not been universally accepted. Many studies differ in measurement tools, evaluation criteria, and diagnostic thresholds, with significant differences in reliability, validity, and comparability (5). Presently, there are few studies on the effects of the ICOPE tool in terms of diagnosis (e.g., sensitivity and specificity), such as the Spanish VIMCI study. In contrast, several studies in China and Brazil focus on assessing implementation feasibility and early outcomes only, and not on an overall evaluation of the tool’s discriminant validity. Thus, there is an urgent need for more validation research of the tool’s psychometric properties to enhance its discrimination ability and usability across various populations and contexts. This study aimed to conduct a systematic review of the literature related to the implementation and validation of ICOPE globally from 2017 to 2026. Further, the review will also focus for advancements in validation and regional variation in screening and intervention related to “intrinsic capacity” in various areas. To systematically evaluate the implementation strategies and impacts of the ICOPE tool, this review may use the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework as its perspective. This framework facilitates a holistic evaluation of a tool’s coverage, effectiveness, and integration into diverse healthcare systems. Consequently, this study may provide a research-based framework for the formulation of a standardized and comparable system for implementing and evaluating ICOPE.
+
+2 Materials and methods
+
+2.1 Inclusion and exclusion criteria for literature
+
+This study developed the following inclusion criteria for the literature. The study population should comprise community-dwelling older adults (aged 60 years or older). The study should address any aspects of implementation within the ICOPE framework, which can include, but are not limited to, screening, assessment, monitoring of decline, or intervention to enhance intrinsic capacity. Acceptable study types include original research studies, reviews, project reports, and conference abstracts, provided that the literature contains extractable original data or a clear explanation of the ICOPE implementation methods. Articles included in this study dated from 2017 to the present day. The published literature meeting the inclusion criteria may be systematically and manually searched. A manual and systematic review of the published literature meeting the exclusion criteria may be conducted to identify duplicate publications (see Table 1).
+
+Table 1 Global ICOPE validation studies based on design, implementation, and key indicators.
+
+No.	Country/region	Year published	Study design	Implementation phase	Sample size	Quantitative indicators	Implementation strategies; adaptation	Reference	
+1	France	2020–2021	Prospective cohort study	Large-scale implementation	10,903	Screening positive rate: 94.3%; vision impairment: 68.1%	Developed ICOPE app software and self-monitoring devices, offered freely on Apple and Android stores, enabling remote assessment and care reminders.	(6, 7)	
+2	China	2023	Cross-sectional diagnostic accuracy study	Strict validation	376	Prevalence of intrinsic capacity decline: 43%; screening positive rate: 69.1%	Led by Xuanwu Hospital, Capital Medical University, conducted the ICOPE-China project in communities, first validating the applicability of the WHO ICOPE screening tool in the Chinese population.	(10)	
+3	South Korea	2020	Randomized controlled trial	Strict validation	Not specified	The Korean Frailty Index for Primary Care (KFI_PC) already includes 8 core ICOPE items.	Implemented the ICOOP_Frail project in primary care clinics, integrating medical, social, and psychological support to person-centered enhance healthy aging.	(12)	
+4	Brazil	2025	Multicenter prospective cohort study	Large-scale implementation	3,838	Screening positive rate: 89.3%	Conducted the Projeto ICOPE Brasil across multiple regions, focusing on the Portuguese language localization and cultural adaptation validation of the ICOPE screening tool.	(14)	
+5	Mexico	2023	Prospective community assessment study	Pilot/feasibility study	387	Sensitivity: 0.82; specificity: 0.76	Conducted in Minatitlán, Veracruz; used mixed methods to evaluate the feasibility and acceptability of ICOPE at the community level.	(15)	
+6	Canada	2024	National multicenter prospective cohort study	Preparation stage	2,341	Intrinsic capacity decline detection rate: to be refined	Conducted in Ontario, British Columbia, and Quebec, aims to provide localized evidence for the nationwide promotion of ICOPE.	(19)	
+7	India	2022	Cross-sectional study	Strict validation	451	Men: 54.5%; high illiteracy rate	Conducted in the rural area of Jodhpur, Rajasthan (Thar Desert), validating the applicability of the ICOPE tool in populations with low education and in rural settings.	(11)	
+8	Vietnam	2023	Cross-sectional validation study	Pilot/feasibility study	200	Screening positive rate: 75.5%	Conducted in Ho Chi Minh City, evaluating the reliability, validity, and feasibility of the ICOPE screening tool in urban Vietnamese communities.	(13)	
+9	Qatar	2024	Mixed-method study	Pilot/feasibility study	1,248	Intrinsic capacity decline detection rate: To be refined	Used the RE-AIM implementation evaluation framework, combining quantitative and qualitative methods to assess implementation barriers and facilitators of ICOPE in the Middle East region.	(12)	
+10	Singapore	2024	Mixed-methods study	Preparation stage	367	Visual impairment: 42.0%	Conducted in a multicultural context, focusing on evaluating the acceptability and implementation strategies of ICOPE in multilingual, multicultural populations.	(16)	
+11	Kenya	2023	Descriptive case study	Preparation stage	Not specified	Data to be refined	Currently in the ICOPE implementation preparation stage, using case studies to map existing resources to provide a foundation for subsequent piloting.	(13)	
+12	Taiwan	2023	Prospective cohort study	Preparation stage	2,156	Cronbach’s α = 0.82	Conducted a prospective cohort study in the community to validate the reliability of the ICOPE screening tool, providing localized evidence for regional promotion.	(17)	
+13	Hong Kong	2023	Prospective cohort study	Preparation stage	1,847	Screening positive rate: 72.1%	Conducted in Shui Po, Yau Tsim Mong, and Kowloon City districts, leveraging 12 older adults district centers and 8 neighborhood older adults centers to assess the implementation effectiveness of ICOPE in urban communities.	(18)	
+14	Spain	2022	Cross-sectional diagnostic accuracy study	Pilot/feasibility study	207	Sensitivity: 0.438–0.889; specificity: 0.682–0.96	The VIMCI cohort study validated the diagnostic accuracy of the ICOPE screening tool in the Spanish population, providing a basis for subsequent large-scale implementation.	(8)	
+15	Italy	2023	Longitudinal cohort study	Pilot/feasibility study	400 + (aged 75+)	Intrinsic capacity decline detection rate: to be refined	Applied the ICOPE model in primary care, combined with tools like the frailty screening test and chair rise test, to evaluate the feasibility and effectiveness of ICOPE within the Italian healthcare system.	(9)	
+
+2.2 Search strategy
+
+Databases in both English and Chinese, including CNKI, Wanfang Database, VIP Database, PubMed, Web of Science, Embase, Scopus, and SinoMed, were accessed through computer searches. The databases for official and grey literature encompassed WHO IRIS, the Global Health Library, and the websites of health departments from various nations. The search timeframe was set from January 2017 to January 2026 to include significant research conducted since the ICOPE framework was officially launched by WHO. The search strategy integrated subject terms alongside free text and used the Boolean logic operators for combinations. For instance, in CNKI, the Chinese search equation was structured as follows: (SU = ‘WHO ICOPE’ + ‘Integrated care for older adults’ + ‘ICOPE’) AND (SU = ‘Intrinsic capacity’ + ‘Intrinsic function’ + ‘IC capacity’) AND (SU = ‘older adults’ + ‘Old age’ + ‘Advanced age’) AND (SU = ‘Screening’ + ‘Assessment’ + ‘Implementation’ + ‘Pilot’ + ‘Validation’ + ‘Tool’). Taking PubMed as an example, the English search formula is as follows: (“ICOPE”[Title/Abstract] OR “Integrated Care for Older People”[Title/Abstract] OR “Integrated Care for Older Persons”[Title/Abstract]) AND (“Intrinsic Capacity”[Title/Abstract] OR “IC Capacity”[Title/Abstract]) AND (“Aged”[MeSH Terms] OR “Older adults”[Title/Abstract] OR “Older Adult”[Title/Abstract]) AND (“Screening”[Title/Abstract] OR “Implementation”[Title/Abstract] OR “Validation”[Title/Abstract] OR “Pilot”[Title/Abstract] OR “Instrument”[Title/Abstract]).
+
+2.3 Literature screening and data extraction
+
+The EndNote application was used for the collection of literature and deletion of duplicates in this study. Two researchers screened the literature. After analyzing the literature, a classification was developed to form a comprehensive and impartial evaluation index system. In situations where agreement was not reached during screening; a third party was involved in discussions until agreement was reached. When needed, consensus meetings or a third, senior reviewer (the corresponding author) resolved disagreements. During data extraction, the collected information includes important evaluation indicators, including the country or region of the study, type of study, publication year, study design, sample size at the implementation stage, positive screening rate, intervention coverage rate, sensitivity and specificity of the tool, and the detection rate of decline in intrinsic capacity.
+
+3 Results
+
+3.1 Study selection and global overview of key indicators
+
+A preliminary review of articles yielded a total of 2,764 articles. The screening was done rigorously using the inclusion and exclusion criteria on the titles, abstracts, and full-texts. Ultimately, 14 essential articles that satisfied the criteria were included in this evidence-based guideline. The publication distribution of these articles included Europe (France (6, 7) (n = 2), Spain (n = 1) (8), Italy (n = 1) (9), and Andorra (n = 1) (6)); Asia (China (n = 1) (10), India (n = 1) (11), South Korea (n = 1) (12), Vietnam (n = 1) (13), and Qatar (n = 10) (12)); America (Brazil (n = 1) (14) and Mexico (n = 1) (15)); Africa (Kenya), Singapore (16), Taiwan (17), Hong Kong (18), and Canada (19). Most studies (n = 9) included in articles published between 2017 and 2026 were published after 2022.
+
+Research methodology and participant characteristics differ widely across global use of the ICOPE screening tool. The first screening of published articles identified 2,764 studies. The titles and abstracts, along with the full texts, were screened rigorously according to the inclusion and exclusion criteria. Ultimately, 14 essential articles that met the inclusion criteria were included in this guideline. Figures 1, 2 shows a PRISMA flow diagram depicting the selection of studies. The illustration shows the sample sizes of ICOPE validation studies across different regions worldwide from 2021 to 2025. The varying shades of green on the map indicate sample size, with the deepest green indicating the highest sample size. The main tools used for measurement were the WHO ICOPE Screening Tool and its modifications. The number of participants varied, a lot from hundreds to tens of thousands. Presently, the most important project in France is INSPIRE with several participants (n = 27,082). The key performance indicators show significant differences. The sensitivity of the ICOPE screening tools ranges from 0.76 to 0.89; the specificity ranges from 0.69 to 0.76; and a large disparity in positive screening rates from 40 to 94.3%. Preliminary diagnostic accuracy results from Spain show a sensitivity of 0.889 for the cognitive domain, while sensitivity for most functional domains ranged from 0.438 to 0.569, and specificity from 0.682 to 0.96. These deviations indicate the substantial risk of false positives. The subsequent analysis of deviation is based on these results.
+
+Figure 1 The distribution situation of each country is detailed in the following.
+
+World map graphic showing the distribution of ICOPE validation status with countries shaded in varying green tones indicating large-scale implementation, rigorous validation, and feasibility or pilot studies, alongside participant sample sizes.
+
+Figure 2 Screening flowchart.
+
+PRISMA flow diagram summarizing study selection for a systematic review, showing initial identification of 2,764 records from databases, sequential removal of duplicates and ineligible records, 516 records screened, 229 reports sought, 68 assessed for eligibility, and 17 studies included in the final review with 14 reports.
+
+3.2 Structured comprehensive analysis: determinants of heterogeneity
+
+In an effort to go beyond descriptive statistics, this study structured the results to identify the underlying causes of variation. The three related factors include development of regional implementation, different research purposes, and varying methodological benchmarks.
+
+3.2.1 Geographic region and implementation stage: the role of infrastructure
+
+A unique developmental gradient is shaped by differences in digital infrastructure and the maturity of health systems. From a geographical perspective, large-scale validation and deployment are underway in Europe (particularly France and Spain) and in several Asian nations, including China and South Korea. This progress has been facilitated by the comprehensive embedding of digital solutions. Initiatives in France and China encourage the use of digital tools (e.g., ICOPE monitor and chatbots) to increase screening coverage; in France, approximately 56% of screenings are conducted through this application. Another implementation strategy must be sought in regions that lack such infrastructure. Regions in Latin America, parts of Africa, and some parts of Southeast Asia are still in the pilot and early project stages, with a focus on basic feasibility studies. A study in Mexico focused on community-level feasibility, whereas studies in Kenya and Canada are currently in the preparatory phase. The “implementation stage” variation is not about timing but local capability to support digital and multi-disciplinary integration.
+
+3.2.2 Research design and tool performance: the trade-off between reach and precision
+
+The observed range of positivity rates is primarily an artifact of study design objectives, yielding a trade-off between reach and precision. The INSPIRE project (in France) and another study in Brazil are the two large implementation studies. Research emphasizing “reach” may produce high screening rates but low precision. The positive screening rate in the INSPIRE project (France) was 94.3%. Although the screening yielded extensive coverage, it implies a high risk of false positives, which could strain the healthcare system. On the other hand, diagnostic accuracy studies are otherwise conducted with psychometric rigor, revealing the important limitation of the tool’s sensitivity in non-cognitive domains. The sensitivity in the cognitive domain was at least 0.889. Furthermore, across most functional domains, sensitivity ranged from 0.438 to 0.569, in the VIMCI study (Spain). The discrepancy indicates uneven detection across domains and also suggests that indiscriminate implementation in primary care may miss declines in mobility or sensory domains.
+
+3.2.3 Cultural adaptation and methodological inconsistency: barriers to comparability
+
+The lack of benchmarks for culture adaptation and assessment has introduced systematic biases in the data, posing the biggest challenge in achieving global comparability. In the first place, cultural and linguistic factors affect the performance of specific products. Validation efforts conducted in non-Western contexts demonstrate that extensive localization is required. For example, an Indian study focused on a rural population with limited education, while a Brazilian initiative validated the Portuguese-language version of the tool. Subsequently, direct cross-cultural comparisons of screening rates are methodologically limited, as the psychometric properties of the tools differ across cultures. Furthermore, varying assessment criteria also lead to fragmentation of the data. At present, there are no standard definitions for what constitutes a “positive” screening result. A research effort in Brazil implemented ICOPE with IVCF-20, and a study in Mexico used MUSIQ to evaluate the implementation environment. The “screening-assessment” process varies widely because a diverse range of additional instruments is used. Due to these different methodologies, it is impossible to compare prognostic values among studies, and the findings may not be globally applicable.
+
+4 Discussion
+
+4.1 Global implementation overview and characteristics of positive screening rates
+
+This review provides the first systematic synthesis of the heterogeneous patterns in the global validation of the ICOPE tool. By applying the RE-AIM framework (41), three core mechanisms underlying this heterogeneity emerge: disparities in implementation stages driven by infrastructure, the trade-off between reach and precision in study design, and the profound impact on cultural adaptation. These findings provide a direct evidence-based foundation for constructing standardized implementation pathways tailored to different resource settings. To investigate the global results using a systematic implementation approach, this study first assessed the ICOPE screening tool’s reach and coverage. Studies from different parts of the world show that the ICOPE framework, which the WHO recommends to enhance and maintain intrinsic capacity, is a key strategy to support healthy aging. The real rates of positive cases vary greatly across countries. One such study, the INSPIRE study in France, screened 27,082 older persons, achieved broad coverage. Other studies reported sample sizes that ranged from hundreds to thousands. The differences not only indicate the dispersion of health status among older adults but are also largely influenced by factors such as study design, target population characteristics, evaluation criteria, and socio-cultural contexts. In a thorough community screening effort in France, 90.8% of first-round participants tested positive during the preliminary evaluation. This indicates that older people in this country, not just diagnosed ones, but also non-healthcare professionals and self-reported ones, are at risk of declining intrinsic capacity. In contrast, a study of mainly independent older people in Catalonia, Spain, found that while 79% experienced a decline in at least one domain, pilot screening in this region was more targeted and generally followed stricter diagnostic criteria. The national ICOPE assessment for Taiwan in 2023 covered a more extensive community population aged 65 and older, including indigenous people aged 55 and older. The rates of detection were low with 15.75% for cognitive impairment, 15.52% for vision, and 4.15% for mental health issues. This difference arises primarily from the different scopes of the screenings. When testing is directed at a broader community rather than a defined high-risk group, the positivity rate is expected to be lower.
+
+4.2 Evaluation of implementation outcomes and ongoing issues
+
+Going beyond coverage, the problems related to efficiency and feasibility in the implementation process are serious. The implementation of ICOPE faces many barriers. Significant difference between screening and screening intervention for stroke. The majority of the research is on screening, and no data are available on what happens afterward and how far the intervention leads; thus, the effect of ICOPE on preserving function and reducing mortality cannot be assessed. A study in Brazil found that people with multi-domain deficits are at a higher risk of death than people with a deficit in one domain. Still, data on the interventions remain incomplete. Furthermore, there is a technological gap regarding digital solutions. The ICOPE MONITOR App and ICOPE BOT in France have significantly improved the efficiency of screenings, yet the self-reported functional abilities of the population seem much better than the assessments made by health professionals. This is a clear example of a “digital divide” that may lead to missed diagnoses of high-risk individuals. Research conducted in Singapore and Mexico has shown that older adults are not very accepting of digital tools. Another factor detracting from the overall management is the lack of sufficient interdisciplinary collaboration and incomplete referral pathways. For instance, the need to establish pathways for referrals to optometry and ENT specialists was highlighted in Singapore. No criteria have been established to determine the standards of adjustment for adaptation and localization of culture. A Brazilian study applied ICOPE with IVCF-20. At the same time, research in Mexico used MUSIQ to map the implementation environment, which displayed a lack of support in the external environment for effective implementation. France’s attainment of 100% intervention coverage offers a model that could help with these issues. It is important to enhance the training of personnel in primary healthcare within a collaborative framework that incorporates different disciplines. This study further localize the tools so that they fit the local healthcare system and context rather than simply being translated directly. Thus, validation studies regarding the ICOPE scale as a screening tool of the framework are witnessing a growing trend of diversifying in recent years with regard to the improvement of standardization, validation of cross-cultural applicability, and broadening of predictive validity. The latest evidence shows that the ICOPE scale may detect functional decline in older people with respect to cognition, mobility, and psychological wellbeing through a two-step assessment (screening followed by a comprehensive assessment). The ICOPE scale showed a sensitivity of 95% and specificity of 57.6% (20); so, item design should be further improved as per local needs.
+
+The ICOPE scale incorporates three technological advancements. First, it evaluates several dimensions, overcoming the limitations of the one-dimensional studies conducted previously. The evaluation of integrated care across multiple domains may assist in developing a better understanding of the global health of older people, through the independent evaluation of cognition, mobility, sensation, vitality, psyche, and vision (21). For example, a randomized controlled trial in Chaoyang District, Beijing, found that people in the ICOPE intervention group, compared with those in the control group, had an improvement in mobility (SPPB scores) and psychological wellbeing (GDS scores) after 6 months (p < 0.05) (22). In addition, the design is easy to use for primary care. A validation study in Taiwan found that the brief screening was completed in 2 min and was highly associated with the full MMSE (r = −0.752) (23). Lastly, it was quite extraordinary to foresee the clinical outcomes of a negative event. According to a Brazilian study, scores in the mobility and hearing domains presented a significant association with falls (OR = 2.27, p = 0.0157) (24). Similarly, the French MAPT study demonstrated its ability to predict disability over 5 years (aHR = 1.74) (25). At present, the research focuses on localization and new technologies. Researchers conducted a receiver operating characteristic curve analysis in Shanghai, discovering a threshold effect (an inflection point value of 4.476) for metabolic markers TyG–WHtR and a decline in the vitality domain (26). It is well-established that biomarkers may be used alongside the ICOPE Scale. A research study using a structural equation model conducted in Hong Kong indicates that ICOPE scores were significantly related to self-care abilities (β = 0.21) and social participation (β = 0.31) (27). The importance of these studies must be kept in mind while assessing social functioning. Moreover, in the context of the INSPIRE-T cohort study, a dynamic prediction model for the ICOPE scale was developed by merging multiple data types (clinical assessments, biological samples, and digital monitoring) (28). This shows that validation research is changing from static screening methods to dynamic monitoring methods.
+
+4.3 Analysis of the implementation path of ICOPE as an integrated care strategy
+
+For the ICOPE framework to function optimally, the screening tools must be accurate and enable a smooth transition from screening to intervention. Lessons from international policies have identified three shared models of implementation that highlight critical issues on the roadmap to integration and local adaptation strategies. The French project INSPIRE had already screened 27,000 older adults through the digital tools such as ICOPE MONITOR. Approximately 56% of the screening was conducted through this app, demonstrating the potential of digital technology for outreach (6, 7). However, findings reveal a significant threat posed by the gap between front-end and back-end integration. Despite a positive screening test rate of 94.3%, only 8.9% of participants underwent a second test. The rapid rollout of digital screening initiatives, coupled with limited professional capacity for assessment, constitutes the main barrier in the “screening-assessment” stage of the integrated care pathway.
+
+In contrast, the Brazilian Proyecto ICOPE Brasil adopts a collaborative approach to localization rather than a screening volume approach. This project may ensure the Portuguese localization and cultural fit of ICOPE screening instruments while exploring models of multi-disciplinary collaboration. Within the context of existing community healthcare, this method emphasizes the establishment of an integrated pathway through personnel training and inter-departmental links. Coverage appears to advance slowly at first; however, it is heavily nuanced and impacted by a focus on sustainable services and groups.
+
+The third model is similar to the ICOPE–China, but implemented within China. This model relies on major medical organizations, such as Xuanwu Medical College Hospital, to conduct verification and community applications, thereby establishing a direct link between experts and the grassroots level (10). The differences between these models signal varying dependencies in the design of integrated care pathways. The focus of the studies is on the kind of collaboration taking place among personnel (professional team and local staff) and their interaction in exchanging information (through automated digital systems or manual referrals). Moreover, these studies investigate service–delivery integration, ranging from standard procedures to flexible approaches, essentially reflecting the democratic or participatory nature of the process.
+
+Future integration must adopt a comprehensive approach. This involves using digital resources to enhance the initial “screening” process while simultaneously developing a robust “assessment-intervention” support framework on the backend, akin to established referral pathways and collaborative teams spanning multiple disciplines. It is crucial to align these pathways with local healthcare facilities and relevant cultural insights.
+
+4.4 Analysis of sources of heterogeneity
+
+The differences in positive screening rates observed across the included studies are likely due to fundamental differences in objectives, population characteristics, and methodology. The studies do not necessarily reflect differences in health status per se.
+
+4.4.1 Design-induced variability
+
+The vastly different positivity rates, ranging from 94.3% in the French INSPIRE study to 15.75% for cognitive impairment in the Taiwan assessment, primarily reflect differences in the aims of the study designs. The French trial was one of large-scale implementation cohorts. A screening approach was used to detect any risk of decline. This approach yields high sensitivity but carries a high risk of false positives. In contrast, other studies that targeted specific high-risk populations or applied stricter diagnostic criteria, this study resulted in a low positivity rate. This phenomenon, known as “dilution effect,” shows that higher positive rates in the implementation studies may suggest over-screening or a need for tighter filters for secondary assessment rather than intrinsic capacity decline being more prevalent.
+
+4.4.2 Psychometric and cultural variability
+
+The variability is further complicated by the tool’s inconsistent psychometric efficacy across different cultures. Validation research indicates significant fluctuations in sensitivity; for instance, the Spanish VIMCI study demonstrated high sensitivity (≥0.889) within the cognitive domain, whereas majority of the functional domains exhibited sensitivity levels ranging from 0.438 to 0.569. This suggests that the tool’s capacity to identify decline is inconsistent across various domains and populations. Additionally, the absence of standardized evaluation criteria for areas such as “vitality” and “mental state” results in differing thresholds for a positive screening outcome. Cultural adaptation is also crucial; for example, a study conducted in Brazil specifically aimed at validating the Portuguese localization of the tool, underscoring that both linguistic and cultural factors directly influence screening results.
+
+4.4.3 Implementation context
+
+Finally, the context of implementation varies. The gap between screening and intervention in many studies means that the measured rate of positive screenings rarely leads to a verified diagnosis. This complicates the accurate calculation of true prevalence.
+
+5 The limitations of the study and the directions for future research
+
+The ICOPE scale developed by the WHO has been found to be sensitive and pragmatic for assessing decline in intrinsic capacity (IC) among older adults (29). However, although a formal risk of bias assessment is not always requisite for scoping reviews, it is essential to acknowledge the variability in study quality among the included studies and has potential impact on the interpretation of findings. Important limitations in the validation studies still exist and must be addressed urgently.
+
+First, the specificity of the scale tends to vary, producing noticeable irregularities in sensory (such as vision) and cognitive areas. For example, Giudici et al. (30) reported a specificity of 2.7% for vision screening and 55.6% for cognitive factors. This indicates that the scale may produce a large number of false-positive results, which can cause overuse of full evaluations and misappropriation of healthcare resources. On the other hand, vitality only has a sensitivity of 51.3% (31), failing to address issues such as malnutrition. Furthermore, the scale emphasizes constraints in adapting to different cultures or physiologies.
+
+Second, the samples used in the validation studies are often unrepresentative. At present, the research on older adults has been conducted primarily among community-dwelling older adults, which is on a particular urban site (e.g., Beijing, Hong Kong, and Shanghai), with average age of 84 years. This focus excludes younger older adults and those living in rural areas, limiting the generalizability of the validation results to broader, more diverse populations.
+
+Further, majority of the studies are cross-sectional in nature (25), resulting in a lack of longitudinal data needed to assess the predictive validity of the scale, more specifically, its long-term capacity to serve as an early indicator of falls (32) or cognitive decline (33). Moreover, a significant lack of standardization, and challenges in adaptability to culturally specific issues are evident. The ICOPE scale items (e.g., “date of the week”) may be subject to environmental factors, including language and education (22), and the criteria for “vitality” or “mental state” assessment (e.g., MNA–SF and GDS scales) vary between regions (34). This variability makes direct comparison of the findings with other studies and restricts the global applicability of the scale (35).
+
+In conclusion, the comorbid conditions were not assessed for their multidimensional interactions. The ICOPE scale consists of six different IC domains, but it does not examine whether they can be synergistic or antagonistic (36). The associations between decreased vitality, metabolic-inflammatory markers (e.g., NLR and TyG index), and association between declined locomotor and cognitive functions (37) underscore the need for more sophisticated models to enhance screening.
+
+Future research should investigate the existing methodological diversity that may support the ICOPE transition from varied validation approaches to standardized applications. Standardizing evaluation criteria and screening instruments must be the primary objective. For parameters such as “vitality” and “mental-wellbeing,” this study should advocate for standardized tools with cross-cultural validity rather than different scales such as MNA-SF and GDS. Developing a set of core outcomes based on global or regional consensus would allow researchers to compare patterns of functional decline among older people across countries. The emphasis should be on capturing key dimensions (such as functional status, quality of life, rates of service use, and costs) rather than focusing solely on the rates of positive screening, which are difficult to verify. The proposed outcome measures will also facilitate resource planning (22).
+
+In view of this methodological agreement, research designs should be more systematic and cohesive. On the one hand, there is a need to identify core outcome indicators (such as functional status, quality of life, and mortality) through multi-center cohort studies. Additionally, biomarkers and dynamic threshold tools (38) should be integrated to improve the accuracy and generalizability of measurements. Concurrently, the ICOPE framework must be incorporated into primary healthcare and long-term follow-up systems, and cost-effective analyses must be conducted. Attention should also be paid to implementation in low-income countries, and the application of ICOPE in low-resource settings requires further examination. There is a strong need to increase the multidisciplinary collaboration and systematic training for better quality implementation. The impacts on target populations, especially high-risk target populations such as long-term care home residents and older adults in rural areas, should be monitored. In addition, to further develop a more comprehensive evidence base aimed at promoting informed policy development, the cost-effectiveness of ICOPE in tiered diagnosis and treatment should be assessed (39). The ultimate focus is to build a framework for evidence-based, cost-effective integrated care that uses local strength and is sensitive to local resources.
+
+Given this methodological consensus, research designs should be more systematic and cohesive. First, outcome measures such as function, quality of life, and survival should be determined using a multi-center cohort study. Moreover, to improve the precision and generalizability of the measurements, biomarkers and dynamic threshold tools may be used (40). In contrary, the application of the ICOPE framework in primary healthcare, follow-up system in long-term, and cost-effectiveness analysis should be priorities. Additionally, research must investigate the implementation of ICOPE in low-income countries and its potential use in low-resource settings. Collaborations between disciplines and systematic training are needed for a better quality of implementation. Effects on target groups, in particular, vulnerable populations such as long-term care home residents and older adults living in rural areas, should be monitored closely. A strong need for cost-effective evaluations of ICOPE in stratified diagnosis and treatment to establish stronger evidence base for informed policy-making (39). This study aimed to develop a model of integrated care that is evidence-based, cost-effective, draws on local strengths, and is sensitive to local resources.
+
+6 Policy and practical implications
+
+At the policy level, the first step is to embed ICOPE into the national primary healthcare system. National initiatives such as China’s “Healthy Aging 2030” and Brazil’s Sistema Único de Saúde (SUS) may facilitate the integration of ICOPE, enabling early detection, comprehensive management, and the development of referral pathways from community to specialist care. Also, a network of collaboration through various disciplines, which has established referral channels, is necessary to ensure that these people receive treatment promptly after screening positive. An exemplary model is the French initiative, which trained non-specialist personnel (e.g., nurses and pharmacists) to conduct screening, thereby alleviating the workload of specialist physicians. Furthermore, it is important to strengthen the training of primary healthcare providers to improve their capacity to deliver ICOPE and to ensure the integrity of the screening and assessment process. Finally, to ensure inclusivity among different groups, it is also necessary to address the digital divide. Additionally, a mixed bag (such as digital and manual) should be used to meet the needs of different groups.
+
+7 Conclusion
+
+This study gathers global data affirming the validation of the WHO ICOPE screening tool, albeit with considerable variation in implementation and effect across different cultures and regions. Healthcare institutions must prioritize creating unified implementation tactics that are adapted to local assets to address these issues, as the system that validates the process does not yet provide a cohesive diagnostic standard. Based on these findings, this study recommend three actionable steps. First, future studies must focus on harmonizing key measurement indicators, since the psychometric characteristics of the tool vary across different contexts and there are no common evaluation criteria. In addition, there is a need to develop a closed-loop management framework that links screening, assessment, and intervention due to the existing disjuncture between screening and intervention. A mixed model, digital and traditional, should be implemented to ensure equity and address the digital divide. Thus, reliance on digital tools should not result in omissions of diagnosis for a considerable section of high-risk groups. Combating fragmentation requires collaboration across disciplines and the establishment of clear referral pathways.
+
+Data availability statement
+
+The datasets presented in this article are not readily available due to license restrictions. Further inquiries can be directed to the corresponding authors.
+
+Author contributions
+
+YZ: Writing – review & editing, Writing – original draft. MH: Data curation, Writing – original draft, Writing – review & editing. SZ: Visualization, Conceptualization, Writing – original draft. LG: Methodology, Data curation, Writing – review & editing, Investigation. GL: Writing – review & editing, Validation. YT: Writing – review & editing, Validation. JY: Writing – review & editing, Resources. BL: Writing – review & editing, Visualization. YS: Writing – review & editing.
+
+Conflict of interest
+
+The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
+
+Generative AI statement
+
+The author(s) declared that Generative AI was not used in the creation of this manuscript.
+
+Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Edited by: Hailun Liang, Renmin University of China, China
+
+Reviewed by: Marco Antonio Melgarejo-Hernández, National Institute of Medical Sciences and Nutrition Salvador Zubirán, Mexico
+
+Diego Alvarez-Lopez, University of Southern California, United States
+
+
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+31. Gaussens L González-Bautista E Bonnefoy M Briand M Tavassoli N De Souto Barreto P . Associations between vitality/nutrition and the other domains of intrinsic capacity based on data from the INSPIRE ICOPE-care program. Nutrients. (2023) 15:1567. doi: 10.3390/nu15071567, 37049408 PMC10096560
+32. Qin R Huang K Li Z Luan T Miao B Gong L . Potential effectiveness of an ICOPE-based long-term care intervention program for old patients with disabilities in nursing homes: protocol for a mixed methods study. Front Public Health. (2025) 13:1597645. doi: 10.3389/fpubh.2025.1597645, 40959613 PMC12433857
+33. Rodrigues RAP Fernandes DS Silva MPAE Dos Santos ME Bento DYK Borges JDC . Predictive capacity of the integrated care for older people screening tool to assess fall risk in older adults in geriatric care. J Clin Nurs. (2026) 35:804–12. doi: 10.1111/jocn.70063 40899459
+34. Lin CY Liu HL Yang YC Wang JD Li CY Griffiths MD . Feasibility and psychometric properties of integrated Care for Older People Screening Tool for Taiwanese (ICOPES-TW) cognitive screening test. Dement Geriatr Cogn Disord. (2025) 54:137–44. doi: 10.1159/000542272, 39522509
+35. De Oliveira V. P. Ferriolli E. Lourenço R. A. González-Bautista E. Souto Barreto P. de Mello R. G. B. (2023) The sensitivity and specificity of the WHO'S ICOPE screening tool, and the prevalence of loss of intrinsic capacity in older adults: a scoping review Maturitas 177:107818 doi: 10.1016/j.maturitas.2023.107818 37542782
+36. Liu W Qin R Zhang X Li G Qiu Y Zhang G . Effectiveness of integrated Care for Older Pepole (ICOPE) in improving intrinsic capacity in older adults: a systematic review and Meta‐analysis. J Clin Nurs. (2025) 34:1013–31. doi: 10.1111/jocn.17432, 39394639
+37. Ahmed A van den Muijsenbergh M Vrijhoef HJ . Consensus on integrated care for older people among Dutch experts: a Delphi study. Int J Integr Care. (2021) 21:30. doi: 10.5334/ijic.5682, 34963759 PMC8663748
+38. Tian Y Zhang Y Wang S Cheng Q Meng L . Integrated care for older people based on information and communication technology: a scoping review protocol. BMJ Open. (2022) 12:e061011. doi: 10.1136/bmjopen-2022-061011, 35863833 PMC9310179
+39. Kim HS Won CW Lee Y . Adapting WHO integrated care for older people (ICOPE) models to the Korean context: policy relevance and feasibility-a Delphi survey. JAR Life. (2025) 15:100031. doi: 10.1016/j.jarlif.2025.100031, 41551004 PMC12809127
+40. Woo J Yu R Wong M Cheung K Fung N . mHealth as a key component of a new model of primary Care for Older Adults. JMIR Form Res. (2025) 9:e82262. doi: 10.2196/82262, 41417038 PMC12716121
+41. Holtrop JS Estabrooks PA Gaglio B Harden SM Kessler RS King DK . Understanding and applying the RE-AIM framework: clarifications and resources. J Clin Transl Sci. (2021) 5:e126. doi: 10.1017/cts.2021.789, 34367671 PMC8327549
diff --git a/corpus/healthcare/text/4802954c1819af92.txt b/corpus/healthcare/text/4802954c1819af92.txt
new file mode 100644
index 0000000000000000000000000000000000000000..45f1cf099c7430e5628a41b158e6eb0ed244f69c
--- /dev/null
+++ b/corpus/healthcare/text/4802954c1819af92.txt
@@ -0,0 +1,51 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13502544
+PMID: 42636193
+DOI: 10.1371/journal.pone.0356912
+Article ID: PONE-D-26-40484
+Article version: 1
+Subjects: Correction
+
+Correction: Validation of stearoyl-coA desaturase gene TaqMan probe-based SNP for genotyping Tattykeel Australian White MARGRA lamb for health-beneficial omega-3 long-chain fatty acids and intramuscular fat content
+
+Malau-Aduli Aduli Enoch Othniel
+Pewan Shedrach Benjamin
+Mwangi Felista Waithira
+Otto John Roger
+Electronic publication date: 2026 Aug 24
+Publication date: 2026
+Volume: 21
+Issue: 8
+Electronic Location ID: e0356912
+Copyright: © 2026 Malau-Aduli et al
+Copyright year: 2026
+Copyright holder: Malau-Aduli et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Validation of stearoyl-coA desaturase gene TaqMan probe-based SNP for genotyping Tattykeel Australian White MARGRA lamb for health-beneficial omega-3 long-chain fatty acids and intramuscular fat content 21 1 6 1 2026 e0339573 PLOS One 10.1371/journal.pone.0339573 PMC12773820 41493932
+Figure count: 0
+Table count: 0
+Page count: 1
+
+Ÿ==============================Ÿ
+There is an error in the Acknowledgment section. The correct Acknowledgment section is as follows: The authors gratefully acknowledge The Gilmores of Tattykeel Australian White Pty Ltd, Oberon, New South Wales, Australia for access to herd and farm resources, and the Commonwealth Scientific and Industrial Research Organization SIEF Ross Metcalf STEM Business Industrial Research Fellowship programme. We would also like to appreciate the support of the School of Environmental and Life Sciences, College of Engineering, Science and Environment, The University of Newcastle, Callaghan, New South Wales, Australia and James Cook University, Townsville, Queensland, Australia.
+
+
+Reference
+
+1 Malau-Aduli AEO , Pewan SB , Mwangi FW , Otto JR . Validation of stearoyl-coA desaturase gene TaqMan probe-based SNP for genotyping Tattykeel Australian White MARGRA lamb for health-beneficial omega-3 long-chain fatty acids and intramuscular fat content. PLoS One. 2026;21(1):e0339573. doi: 10.1371/journal.pone.0339573 41493932 PMC12773820
diff --git a/corpus/healthcare/text/5acbdbe07ee5c4f8.txt b/corpus/healthcare/text/5acbdbe07ee5c4f8.txt
new file mode 100644
index 0000000000000000000000000000000000000000..93065172e4b14dd7b50bce7b9baaa8b472b5dc83
--- /dev/null
+++ b/corpus/healthcare/text/5acbdbe07ee5c4f8.txt
@@ -0,0 +1,239 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: JMIR Res Protoc
+Journal ID: JMIR Res Protoc
+NLM Journal ID: 101599504
+Journal ID: ResProt
+
+JMIR Research Protocols
+
+EISSN: 1929-0748
+Publisher: JMIR Publications Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11775491
+PMID: 39808788
+DOI: 10.2196/63015
+Article ID: v14i1e63015
+Article version: 1
+Subjects: Protocol, Protocol
+
+Value Cocreation and Codestruction in Digital Health Services: Protocol for a Systematic Review
+
+Schwartz Amy
+Arriaga Rosa
+Laukka Elina RN, PhD https://orcid.org/0000-0003-3959-8591 1 2 Department of Public Health Faculty of Medicine University of Helsinki PO Box 00020 Helsinki, 00014 Finland 358 503380111 elina.laukka@helsinki.fi
+
+Tuunanen Tuure Prof Dr 3 4 https://orcid.org/0000-0001-7119-1412
+Jansson Miia RN, PhD 5 6 https://orcid.org/0000-0001-5815-0325
+Vanhanen Minna RN, PhD 7 https://orcid.org/0000-0002-7771-9756
+Hirvonen Nina BSc 8 https://orcid.org/0009-0008-0632-7705
+Palukka Jenni BSc 8 https://orcid.org/0009-0005-8487-8674
+Vesinurm Märt MSc 8 https://orcid.org/0000-0001-7351-7834
+Torkki Paulus Prof Dr 1 https://orcid.org/0000-0002-1127-4205
+1 Department of Public Health Faculty of Medicine University of Helsinki Helsinki Finland
+2 School of Culture and Wellbeing Oulu University of Applied Sciences Oulu Finland
+3 Faculty of Information Technology University of Jyväskylä Jyväskylä Finland
+4 Department of Informatics and Media Uppsala University Uppsala Sweden
+5 Research Unit of Health Sciences and Technology University of Oulu Oulu Finland
+6 RMIT University Melbourne Australia
+7 Focus Area for Digital Solutions Centre for Research and Innovation Oulu University of Applied Sciences Oulu Finland
+8 Institute of Healthcare Engineering and Management at the Department of Industrial Engineering and Management Aalto University School of Science Espoo Finland
+Corresponding Author: Elina Laukka elina.laukka@helsinki.fi
+Publication date: 2025
+Electronic publication date: 2025 Jan 14
+Volume: 14
+Electronic Location ID: e63015
+Received 2024 Jun 11; Revision requested 2024 Sep 4; Revised 2024 Oct 15; Accepted 2024 Dec 3
+Copyright: ©Elina Laukka, Tuure Tuunanen, Miia Jansson, Minna Vanhanen, Nina Hirvonen, Jenni Palukka, Märt Vesinurm, Paulus Torkki. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.01.2025.
+Copyright year: 2025
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: value cocreation, value codestruction, telemedicine, eHealth, systematic review
+
+Ÿ==============================Ÿ
+Background
+
+To successfully design, develop, implement, and deliver digital health services that provide value, they should be cocreated with patients. However, occasionally, the value may also be codestructed. In the field of health care, the concepts of value cocreation and codestruction still need to be better established within emerging digital health services. Studying these concepts is essential for developing effective and sustainable patient-centered care.
+
+Objective
+
+The aim of the study is (1) to understand the antecedents, decisions, and outcomes of value cocreation and codestruction in digital health services, (2) to define the dynamics between value cocreation and codestruction, and (3) to map future research areas of value cocreation and codestruction within digital health services.
+
+Methods
+
+The systematic review will be conducted in accordance with the Joanna Briggs Institute methodology for mixed method systematic reviews and the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The review considers scientific qualitative, quantitative, or mixed method studies published in English, Finnish, or Swedish that concern either value cocreation or codestruction in digital health services. Studies focusing on physical robotics and online health communities, as well as non–peer-reviewed and nonscientific papers, will be excluded. The searches were conducted using Scopus and MEDLINE during this protocol creation. Critical appraisal will be done using suitable checklists for qualitative, quantitative, and mixed method studies. The review will adhere to a convergent integrated approach as outlined in the Joanna Briggs Institute methodology for mixed methods systematic reviews.
+
+Results
+
+The searches resulted in a total of 837 records. The antecedents, decisions, and outcomes of value cocreation and codestruction in the context of digital health services will be described in a finalized systematic review. In the outcomes, our main interest is the effect on patient outcomes and experiences and professional experiences.
+
+Conclusions
+
+Since our study involves diverse scientific fields, there is a risk that our search does not capture all relevant papers. To mitigate this risk, we used 2 large databases for the searches. In addition, the value cocreation or codestruction terms may not have been used in all studies focusing on the collaborative roles of patients and providers, especially in the medical field, and that may be difficult to capture. The review reveals the current understanding of value cocreation and codestruction in digital health services and shapes the research agenda for these phenomena. Value cocreation can be used to both design and efficiently use digital health services trying to maximize the value for patients.
+
+International Registered Report Identifier (IRRID)
+
+DERR1-10.2196/63015
+
+Introduction
+
+Value cocreation and customers’ interactive roles in the service exchange have been essential to understanding how value is created in services [1]. Rapid technological advances and digital transformation are transforming the context in which value is created [2]. Health care services had a significant transformation as digital health services rapidly expanded during the COVID-19 pandemic [3,4]. Digital health services can be defined as the use of information and communication technologies in health care products, services, and processes [5]. Digital services, including telemedicine interventions, mobile health apps, and remote monitoring devices, have been suggested as a potential solution to tackle issues related to accessibility, availability, and health care costs [6,7]. In addition to the technical development, it also changes the way of thinking and how services are provided and perceived [4].
+
+Cocreation, a burgeoning paradigm within management literature, facilitates the joint creation of value by enterprises and consumers through interactive processes [8]. Since the onset of the 21st century, the concept of cocreation has proliferated extensively, evidenced in scholarly discourse and empirical inquiries, thereby challenging established tenets of capitalist economies. In such economies, value traditionally tends to be predetermined prior to market transactions [8,9]. Health care is a complex service where defining and operationalizing value presents significant challenges [10,11]. Since Porter [12] introduced the idea of measuring health care value as patient-relevant outcomes per costs associated with the health problem, the concept has been widely discussed for its potential to unify the objectives of various stakeholders [11]. In the context of digital health services, value may be more closely related to outcomes and experiences, with costs being more pertinent at the system level.
+
+From the standpoint of cocreation, suppliers and customers are no longer perceived as adversaries but rather as collaborators engaging with each other to foster the emergence of novel business prospects [13]. During the last decade, Yi and Gong [14] established the significance of value cocreation behavior, which provides a multidimensional framework encompassing diverse value cocreation activities, such as information seeking, information sharing, responsible behavior, and personal interaction, that help explain how customers and firms, or patients and health care providers in this case, interact and collaborate.
+
+Additionally, the digitalization of services within health care ecosystems is altering how value is created, delivered, experienced, and evaluated [15,16]. Understanding value cocreation and the interactive roles of customers in the service exchange is crucial for comprehending how value is created in services [1], with value cocreation being conceptualized as a joint problem-solving process [17]. For instance, value cocreation in digital health services can be depicted through customer engagement, encompassing emotional, active, and cognitive dimensions [18].
+
+However, value is not always cocreated. Value codestruction signifies that not all interactions and relationships yield positive or value-creating results; occasionally, these engagements may even lead to adverse outcomes [19,20]. Value codestruction refers to an interactive process between service systems that leads to a reduction in the well-being of at least 1 of the systems, which can affect either individuals or organizations depending on the nature of the service system [20]. For example, value codestruction may manifest in the inability to search for, understand, and use health information gathered on the web [21]. Additionally, the assumption that telemedicine can negatively impact doctor-patient relationships inevitably leads to value-in-use destruction [21].
+
+As digital services differ significantly from traditional services, there is a need to understand how to enhance value cocreation between a service provider and its users in digital services [22,23]. Tuunanen et al [23] identified 5 mechanisms to support value cocreation in the design of digital services, namely social use, customer orientation and decision-making, service experience, service use context, and customer values and goals.
+
+In response to evolving population needs, it is evident that the role of patients within digital health services and health care at large has transitioned toward a collaborative partnership between professionals and patients [24,25]. According to Huber et al [26], the definition of health is also changing from “complete mental, physical, and social well-being” toward “the ability to self-manage and adapt.” According to van Druten et al [27], a similar multifaceted approach to Huber’s concept of positive health was shared by many perspectives. Nevertheless, upon closer examination, it was observed that the core elements of positive health, namely “the ability to adapt and to self-manage,” were also acknowledged in other health concepts, regardless of perspective. These health concepts described “the ability to adapt” as, for instance, adjusting to changing physical conditions like aging, illness, or disability, maintaining emotional balance, and viewing health as a dynamic state requiring adaptation to circumstances. “The ability to self-manage” was often described as autonomy or independence. Through the value cocreation process, professionals and patients can make a significant contribution to health outcomes as partners [28]. For example, patients can provide perspectives on areas of the care process that are invisible to health care professionals [29,30]. Previous literature has discussed many consequences of value cocreation related to health outcomes, service experience, perceived service quality, and service engagement [31].
+
+While value cocreation has also been studied in health care, less attention has been given to the investigation of value codestruction [29,32]. As the field of health care is constantly becoming more digitalized, examining value cocreation and value codestruction in digital services would provide valuable insights into developing such services. Peng et al [31] conducted a systematic review of value cocreation in health care and digital services before the COVID-19 pandemic. They also encouraged researchers to explore further opportunities for value cocreation in both web-based and hybrid environments. Even so, the review by Peng et al [31] did not address value codestruction, which, in conjunction with value cocreation, could aid in enhancing the efficiency of digital health services. Several authors have highlighted the necessity of gaining a more comprehensive understanding of value codestruction and integrating it with the research on value cocreation [33,34]. Considering the pandemic’s impact on digital service expansion [3,4], increasing resource constraints due to rising chronic illnesses, and aging populations [35,36], conducting a new systematic literature review could provide a contemporary perspective on value cocreation in health care. Furthermore, this review aims to provide a more comprehensive understanding of value codestruction.
+
+So as to gain a more current understanding of both value cocreation and value codestruction in digital health services, this review seeks to identify scientific studies published between 2020 and 2024, using the Joanna Briggs Institute’s (JBI) guidance for mixed method systematic reviews [37] and adhering to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist for reporting systematic reviews [38] The objectives of the review will be (1) to understand the antecedents, decisions, and outcomes (ADO) of value cocreation and value codestruction, (2) to define the dynamics between value cocreation and value codestruction in digital health services, and (3) to map future research areas of value cocreation and value codestruction within digital health services. To answer the first research question, this review uses a systematic literature review framework, namely, the ADO framework by Paul and Benito [39]. The ADO framework aims to identify the known aspect of any phenomenon, which in the case of this review is value cocreation and value codestruction in the context of digital health services. Our research questions are (1) What are the ADO of value cocreation and value codestruction in digital health services? (2) What are the dynamics between value cocreation and value codestruction in digital health services? (3) What are the most promising future research areas in value cocreation and value codestruction within digital health services?
+
+Methods
+
+Overview
+
+The systematic review will be conducted in accordance with the JBI methodology for mixed method systematic review [37] and the PRISMA statement [38,40] (Multimedia Appendix 1). This protocol has been registered in PROSPERO (International Prospective Register of Systematic Reviews; 549303). During this review protocol, the searches have been conducted, but the screening, quality assessment, and analysis will be carried out in the finalized systematic review.
+
+Search Strategy
+
+Using the search strategy developed by Peng et al [31] as a foundation, adjustments were made to include value codestruction. The search strategy aimed to identify peer-reviewed scientific studies and was conducted in 3 steps. First, to ensure an optimal search strategy for both value cocreation and value codestruction, an initial limited search of MEDLINE and Scopus was conducted on May 21, 2024, which resulted in 48 and 247 papers, respectively. MEDLINE and Scopus were selected since they collectively provide extensive coverage of publications on digital health services, value cocreation, and value codestruction. Second, relevant papers were identified through title, abstract, and index term analysis. An information specialist was consulted during the development of the final search strategy. Keywords were truncated as necessary, and index terms such as MeSH were used in MEDLINE (Multimedia Appendix 2). Additionally, the reference lists of all included studies will be screened to identify additional relevant studies.
+
+Eligibility Criteria
+
+This study will include studies that investigate either value cocreation, value codestruction, or both in digital health services. This review will consider scientific qualitative, quantitative, or mixed method studies. Papers published in English, Finnish, and Swedish will be eligible for inclusion. Only papers published between January 1, 2020, and the present (June 2024) concerning value cocreation were considered, as an earlier review covered the period from 2008 to 2019 [31]. Regarding value codestruction, the limitation period extends from January 1, 2008, to December 31, 2008, since the earlier review did not address value codestruction. Studies focusing on physical robotics, as well as non–peer-reviewed and nonscientific papers, will be excluded.
+
+Study Selection
+
+The results of the search are presented in a PRISMA flow diagram [38]. All citations identified through the described search strategy were compiled and uploaded into Rayyan (Al Rayyan Company), which was also used to remove duplicate entries. Titles and abstracts will then undergo independent screening by 2 team members (NH and JP) using predefined inclusion and exclusion criteria. For papers lacking abstracts, the full text will be obtained. Following the title and abstract screening, potentially relevant studies will be retrieved in full. Two independent reviewers (NH and JP) will thoroughly assess these studies and determine their suitability based on the inclusion criteria. Exclusion reasons will be documented for studies that do not meet the inclusion criteria. Any discrepancies during the study selection or any other process will be resolved through discussion or by consulting a third team member (EL and PT). All search methods, strategies, and sources will be detailed or named in the final report, ensuring replicability.
+
+Assessment of Methodological Quality
+
+Before being included in the review, papers will undergo evaluation by 2 separate reviewers (EL and M Vanhanen) to ensure methodological soundness. We will use the JBI checklists for qualitative and quantitative studies and the Mixed Methods Appraisal Tool for mixed method studies [41]. In cases where necessary, authors of papers will be contacted to request missing or additional data to ensure clarity. The outcomes of critical appraisal will be presented both in narrative form and in a table format. Data extraction and synthesis will be conducted for all studies, irrespective of their methodological quality assessment outcomes, whenever feasible.
+
+Data Extraction and Synthesis
+
+Two independent reviewers (EL and M Vanhanen) will extract both quantitative and qualitative data from the studies included in the review. The extracted data will encompass specific details about populations, study methods, phenomena of interest, context, and outcomes relevant to the review questions. Quantitative data will include outcomes derived from descriptive and inferential statistical tests. Additionally, qualitative data will comprise verbatim themes or subthemes accompanied by corresponding illustrations and will be assigned a level of credibility. Authors of papers will be contacted up to a maximum of 2 times to request missing or additional data, as necessary.
+
+Data Transformation
+
+The quantitative data will undergo a process of “qualitization,” which entails transforming it into textual descriptions or narrative interpretations that directly address the review questions.
+
+Data Synthesis and Integration
+
+This review will adhere to a convergent integrated approach as outlined in the JBI methodology for mixed methods systematic reviews. This approach involves integrating the qualitized data with the qualitative data. The assembled data will be categorized and pooled based on similarity in meaning, ultimately generating a set of integrated findings presented as the line of action statements. We will classify the data using the ADO framework [39]. Additionally, we will synthesize the current knowledge of each dimension and formulate a future research agenda based on the findings.
+
+Ethical Considerations
+
+Since concept analyses solely rely on secondary publicly available data sourced from primary research studies, there is no requirement for research ethics approval.
+
+Validity and Rigor
+
+The following activities will be performed to enhance the review’s validity and rigor:
+
+Method: The systematic review will be conducted following the JBI guidelines [37] and following the PRISMA statement [38].
+
+Search: To increase the reliability of the review, an information specialist with expertise in health care, value cocreation, and value codestruction will be consulted. Additionally, several database sources will be included in the final search to ensure the richness of the data to be analyzed.
+
+Screening, data extraction, and synthesis: Each of the previously mentioned phases will be conducted independently by at least 2 independent team members (NH and JP), which will enhance the reliability of the review.
+
+Process: The research team members (EL, TT, M Vanhanen, NH, JP, MJ, M Vesinurm, and PT) will continuously review the paper during ongoing meetings throughout the process.
+
+Results
+
+The review started in May 2024 and will be completed in a time frame of 8 months. This time phase includes the following phases: screening, data extraction, quality assessment, and data synthesis. The literature search was conducted entirely during the review protocol process and reported in the PRISMA diagram. The final search in MEDLINE and Scopus on June 6, 2024, resulted in 58 and 770 papers, respectively (Figure 1). As Peng et al [31] omitted value codestruction in their search, a supplementary search focusing exclusively on value codestruction was conducted on September 19, 2024, covering the years 2008 to 2019. This search yielded 9 papers from Scopus and none from MEDLINE. In total, 837 records were detected. The systematic review is anticipated to be ready for submission by December 2024.
+
+Figure 1 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram.
+
+Discussion
+
+Principal Findings
+
+Our review will reveal the current understanding of value cocreation and codestruction in digital health services and shape the research agenda for these phenomena. In their review, Peng et al [31] focused on studies published prior to the COVID-19 pandemic, a period after which the number of digital health services has significantly increased. Consequently, our review will provide the most recent insights into value cocreation and value codestruction within digital health services. The ADO framework [39] assists in producing a knowledge map outlining the associations between ADO of value cocreation and codestruction in the context of digital health services. The ADO of value cocreation and codestruction will be described. In the outcomes, our main interest is the effect on patient outcomes and experiences and professional experiences. The more detailed results will be determined based on the finalized review.
+
+Value cocreation can be used in both designing as well as the efficient use of digital health services trying to maximize value for patients. In other digital services, value cocreation and codestruction have been studied more thoroughly, as most of the services nowadays are digital, and the world has already been described as digital-first [42].
+
+As the field of health care is constantly more digitalized, examining value cocreation and codestruction in digital services would provide valuable insights into developing such services. To support the cost-effectiveness of the services and try to minimize the effects of digital exclusivity, it is crucial to understand value cocreation and codestruction better in digital health services.
+
+Strengths and Limitations
+
+Since our study is crossing the scientific fields, there is a risk that our search does not capture all relevant papers. To mitigate this risk, we include multiple databases for the searches. However, only peer-reviewed studies will be included in this review, which excludes gray literature [43]. In addition, the value cocreation or codestruction terms may not have been used in all studies focusing on the collaborative roles of patients and providers, especially in the medical field, and that may be difficult to capture.
+
+The authors would like to thank Aalto University Library for consulting with the search strategy. Open access is funded by the Helsinki University Library.
+
+Multimedia Appendix 1 PRISMA-S (Preferred Reporting Items for Systematic reviews and Meta-Analyses Literature Search Extension) checklist.
+
+Multimedia Appendix 2 Search strategy.
+
+Abbreviations
+
+ADO antecedents, decisions, and outcomes
+
+JBI Joanna Briggs Institute
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+PROSPERO International Prospective Register of Systematic Reviews
+
+Data Availability
+
+The datasets generated and analyzed during this study are available from the corresponding author on reasonable request.
+
+Authors' Contributions: The review protocol was conceived and supervised by EL and PT. EL, TT, MJ, M Vanhanen, NH, JP, M Vesinurm, and PT planned the review and formed the aim and research question. PT, NH, and JP developed the search strategy and conducted the search. EL, NH, JP, and PT screened papers. EL and PT drafted the main text. All authors contributed revisions.
+
+Conflicts of Interest: None declared.
+
+
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+2 Jain S Sharma K Devi S The dynamics of value co‐creation behavior: a systematic review and future research agenda Int J Consum Stud 2023 48 1 e12993 10.1111/ijcs.12993
+3 Ndayishimiye C Lopes H Middleton J A systematic scoping review of digital health technologies during COVID-19: a new normal in primary health care delivery Health Technol (Berl) 2023 13 2 273 284 10.1007/s12553-023-00725-7 36628261 725 36628261 PMC9816012
+4 Rosenlund M Kinnunen UM Saranto K The use of digital health services among patients and citizens living at home: scoping review J Med Internet Res 2023 25 e44711 10.2196/44711 36972122 v25i1e44711 36972122 PMC10131924
+5 Chidambaram S Jain B Jain U Mwavu R Baru R Thomas B Greaves F Jayakumar S Jain P Rojo M Battaglino MR Meara JG Sounderajah V Celi LA Darzi A An introduction to digital determinants of health PLOS Digit Health 2024 3 1 e0000346 10.1371/journal.pdig.0000346 38175828 PDIG-D-22-00377 38175828 PMC10766177
+6 Golinelli D Boetto E Carullo G Nuzzolese AG Landini MP Fantini MP Adoption of digital technologies in health care during the COVID-19 pandemic: systematic review of early scientific literature J Med Internet Res 2020 22 11 e22280 10.2196/22280 33079693 v22i11e22280 33079693 PMC7652596
+7 Petracca F Ciani O Cucciniello M Tarricone R Harnessing digital health technologies during and after the COVID-19 pandemic: context matters J Med Internet Res 2020 22 12 e21815 10.2196/21815 33351777 v22i12e21815 33351777 PMC7775375
+8 Prahalad CK Ramaswamy V Co-creation experiences: the next practice in value creation J Interact Mark 2004 18 3 5 14 10.1002/dir.20015
+9 Vargo SL Lusch RF Evolving to a new dominant logic for marketing J Mark 2004 68 1 1 17 10.1509/jmkg.68.1.1.24036
+10 Sánchez-Fernández R Iniesta-Bonillo MÁ Holbrook MB The conceptualisation and measurement of consumer value in services Int J Mark Res 2018 51 1 1 17 10.1177/147078530905100108
+11 Landon SN Padikkala J Horwitz LI Defining value in health care: a scoping review of the literature Int J Qual Health Care 2021 33 4 mzab140 10.1093/intqhc/mzab140 34788819 6426034 34788819 PMC9162129
+12 Porter ME What is value in health care? N Engl J Med 2010 363 26 2477 2481 10.1056/NEJMp1011024 21142528 21142528
+13 Galvagno M Dalli D Theory of value co-creation: a systematic literature review Manag Serv Qual 2014 24 6 643 683 10.1108/msq-09-2013-0187
+14 Yi Y Gong T Customer value co-creation behavior: scale development and validation J Bus Res 2013 66 9 1279 1284 10.1016/j.jbusres.2012.02.026
+15 Pal S Biswas B Gupta R Kumar A Gupta S Exploring the factors that affect user experience in mobile-health applications: a text-mining and machine-learning approach J Bus Res 2023 156 113484 10.1016/j.jbusres.2022.113484 36475057 S0148-2963(22)00949-3 36475057 PMC9715352
+16 Kraus S Schiavone F Pluzhnikova A Invernizzi AC Digital transformation in healthcare: analyzing the current state-of-research J Bus Res 2021 123 557 567 10.1016/j.jbusres.2020.10.030
+17 Aarikka-Stenroos L Jaakkola E Value co-creation in knowledge intensive business services: a dyadic perspective on the joint problem solving process Ind Mark Manag 2012 41 1 15 26 10.1016/j.indmarman.2011.11.008
+18 Lo Presti L Testa M Marino V Singer P Engagement in healthcare systems: adopting digital tools for a sustainable approach Sustainability 2019 11 1 220 10.3390/su11010220
+19 Echeverri P Skålén P Co-creation and co-destruction: a practice-theory based study of interactive value formation Mark Theory 2011 11 3 351 373 10.1177/1470593111408181
+20 Plé L Chumpitaz Cáceres R Not always co‐creation: introducing interactional co‐destruction of value in service‐dominant logic J Serv Mark 2010 24 6 430 437 10.1108/08876041011072546
+21 Marsilio M Mastrodascio M Technology-enabled value co-creation in healthcare: a configurational approach Public Manag Rev 2024 1 23 10.1080/14719037.2024.2329220
+22 Čaić M Odekerken-Schröder G Mahr D Service robots: value co-creation and co-destruction in elderly care networks J Serv Manag 2018 29 2 178 205 10.1108/josm-07-2017-0179
+23 Tuunanen T Lumivalo J Vartiainen T Zhang Y Myers MD Micro-level mechanisms to support value co-creation for design of digital services J Serv Res 2023 27 3 381 396 10.1177/10946705231173116
+24 Richards T Montori VM Godlee F Lapsley P Paul D Let the patient revolution begin BMJ 2013 346 f2614 10.1136/bmj.f2614 23674136 bmj.f2614 23674136
+25 Popa V Geissler J Vermeulen R Priest E Capperella K Susuzlu G Terry SF Brooke N Delivering digital health solutions that patients need: a call to action Ther Innov Regul Sci 2024 58 2 236 241 10.1007/s43441-023-00592-4 38082118 10.1007/s43441-023-00592-4 38082118 PMC10850017
+26 Huber M Knottnerus JA Green L van der Horst H Jadad AR Kromhout D Leonard B Lorig K Loureiro MI van der Meer JWM Schnabel P Smith R van Weel C Smid H How should we define health? BMJ 2011 343 d4163 10.1136/bmj.d4163 21791490 bmj.d4163 21791490
+27 van Druten VP Bartels EA van de Mheen D de Vries E Kerckhoffs APM Nahar-van Venrooij LMW Concepts of health in different contexts: a scoping review BMC Health Serv Res 2022 22 1 389 10.1186/s12913-022-07702-2 35331223 10.1186/s12913-022-07702-2 35331223 PMC8953139
+28 von Thiele Schwarz U Co-care: producing better health outcome through interactions between patients, care providers and information and communication technology Health Serv Manage Res 2016 29 1-2 10 15 10.1177/0951484816637746
+29 Keeling DI Keeling K de Ruyter K Laing A How value co-creation and co-destruction unfolds: a longitudinal perspective on dialogic engagement in health services interactions J Acad Mark Sci 2020 49 2 236 257 10.1007/s11747-020-00737-z
+30 Elg M Engström J Witell L Poksinska B Co-creation and learning in health-care service development J Serv Manag 2012 23 3 343 10.1108/09564231211248435
+31 Peng Y Wu T Chen Z Deng Z Value cocreation in health care: systematic review J Med Internet Res 2022 24 3 e33061 10.2196/33061 35333183 v24i3e33061 35333183 PMC8994154
+32 Kaartemo V Känsäkoski H Information and knowledge processes in health care value co-creation and co-destruction Sage Open 2018 8 4 1 23 10.1177/2158244018820482
+33 Peng J Yang X Poon P Xie L Enhancing users' well-being in virtual medical tourism communities: a configurational analysis of users’ interaction characteristics and social support Technol Soc 2022 71 102084 10.1016/j.techsoc.2022.102084
+34 Zyzak B Martinussen PE OK computer: applying the public service logic on digital health services Public Manag Rev 2024 26 11 3342 3364 10.1080/14719037.2024.2337080
+35 Murthy VNR Okunade AA Determinants of U.S. health expenditure: evidence from autoregressive distributed lag (ARDL) approach to cointegration Econ Model 2016 59 67 73 10.1016/j.econmod.2016.07.001
+36 Keehan SP Cuckler GA Sisko AM Madison AJ Smith SD Stone DA Poisal JA Wolfe CJ Lizonitz JM National health expenditure projections, 2014-24: spending growth faster than recent trends Health Aff (Millwood) 2015 34 8 1407 1417 10.1377/hlthaff.2015.0600 26220668 hlthaff.2015.0600 26220668
+37 Lizarondo L Stern C Carrier J Godfrey C Rieger K Salmond S Apostolo J Kirkpatrick P Loveday H Aromataris E Lockwood C Porritt C Pilla B Jordan Z Chapter 8: Mixed methods systematic reviews JBI Manual for Evidence Synthesis 2020 Australia JBI 10.11124/JBISRIR-D-19-00169 32813460
+38 Page MJ McKenzie JE Bossuyt PM Boutron I Hoffmann TC Mulrow CD Shamseer L Tetzlaff JM Akl EA Brennan SE Chou R Glanville J Grimshaw JM Hróbjartsson A Lalu MM Li T Loder EW Mayo-Wilson E McDonald S McGuinness LA Stewart LA Thomas J Tricco AC Welch VA Whiting P Moher D The PRISMA 2020 statement: an updated guideline for reporting systematic reviews BMJ 2021 372 n71 10.1136/bmj.n71 33782057 33782057 PMC8005924
+39 Paul J Benito GRG A review of research on outward foreign direct investment from emerging countries, including China: what do we know, how do we know and where should we be heading? Asia Pac Bus Rev 2017 24 1 90 115 10.1080/13602381.2017.1357316
+40 Rethlefsen ML Kirtley S Waffenschmidt S Ayala AP Moher D Page MJ Koffel JB PRISMA-S: an extension to the PRISMA statement for reporting literature searches in systematic reviews Syst Rev 2021 10 1 39 10.1186/s13643-020-01542-z 33499930 10.1186/s13643-020-01542-z 33499930 PMC7839230
+41 Hong QN Fàbregues S Bartlett G Boardman F Cargo M Dagenais P Gagnon MP Griffiths F Nicolau B O’Cathain A Rousseau MC Vedel I Pluye P The Mixed Methods Appraisal Tool (MMAT) version 2018 for information professionals and researchers Educ Inf 2018 34 4 285 291 10.3233/EFI-180221
+42 Baskerville RL Myers MD Yoo Y Digital first: the ontological reversal and new challenges for information systems research MIS Q 2020 44 2 509 523 10.25300/misq/2020/14418
+43 Aromataris E Lockwood C Porritt K Pilla B Jordan Z JBI Manual for Evidence Synthesis 2024 Australia JBI
diff --git a/corpus/healthcare/text/5dac7103f4561d41.txt b/corpus/healthcare/text/5dac7103f4561d41.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Cancer Med
+Journal ID: Cancer Med
+NLM Journal ID: 101595310
+Journal ID: CAM4
+
+Cancer Medicine
+
+EISSN: 2045-7634
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11237879
+PMID: 38989639
+DOI: 10.1002/cam4.7440
+Article ID: CAM47440
+Article ID: CAM4-2023-10-5277.R1
+Article version: 1
+Subjects: Review, Review
+
+Assessing interventions promoting the uptake of cancer‐related genomic services within the Latino community: A scoping review using the RE‐AIM framework
+
+Ramirez Leon et al.
+
+Ramirez Leon Dayanna https://orcid.org/0000-0003-1730-2673 1 dayanna.ramirez@emory.edu
+
+Martinez Denise 1
+Rivera Rivera Jessica 2
+Fuzzell Lindsay https://orcid.org/0000-0001-9688-5365 2
+Vadaparampil Susan 2
+Rogers Hannah 3
+Gabram Sheryl 4
+Snyder Cindy 4
+Guan Yue 1
+1 Department of Behavioral, Social, and Health Education Sciences Rollins School of Public Health, Emory University Atlanta Georgia USA
+2 Department of Health Outcomes and Behavior H. Lee Moffitt Cancer Center and Research Institute Tampa Florida USA
+3 Woodruff Health Sciences Center Library Emory University Atlanta Georgia USA
+4 Georgia Center for Oncology Research and Education Atlanta Georgia USA
+* Correspondence
+Dayanna Ramirez Leon, Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
+Email: dayanna.ramirez@emory.edu
+
+Electronic publication date: 2024 Jul 11
+Publication date: 2024 Jul
+Volume: 13
+Issue: 13
+Electronic Location ID: e7440
+Revised 2024 Jun 11; Received 2023 Nov 3; Accepted 2024 Jun 18
+Copyright: © 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: cancer, evaluation, genetic counseling, genetic testing, Latino health, RE‐AIM
+
+Funding: Emory University RSPH Dean's Pilot and Innovation 2022 Grant 10.13039/100006939
+Figure count: 3
+Table count: 5
+Page count: 17
+
+source-schema-version-number: 2.0
+cover-date: July 2024
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.4.5 mode:remove_FC converted:11.07.2024
+
+Ramirez Leon D , Martinez D , Rivera Rivera J , et al. Assessing interventions promoting the uptake of cancer‐related genomic services within the Latino community: A scoping review using the RE‐AIM framework. Cancer Med. 2024;13:e7440. doi:10.1002/cam4.7440 38989639 PMC11237879
+
+Ÿ==============================Ÿ
+Abstract
+
+Cancer genomic services (CGS) can support genetic risk‐stratified cancer prevention and treatment. Racial/ethnic minority groups are less likely to access and utilize CGS compared with non‐Hispanic Whites. Little research has described characteristics of interventions targeted at CGS among Latinos. This scoping review aimed to (1) describe interventions promoting uptake of CGS among Latinos in the United States and Latin America, (2) describe intervention adaptations for Latino participants, and (3) summarize intervention implementation factors suggested by reach, effectiveness, adoption, implementation, and maintenance (RE‐AIM) framework. We conducted a search in English and Spanish of literature published between 2005 and 2022 across PubMed and Latin American and Caribbean Health Sciences Literature databases. Sixteen of 2344 papers met the inclusion criteria of the analysis. Efforts to promote CGS among Latino communities were limited in the US and lower in Latin America. This review highlights the need for in‐depth exploration of acculturation‐informed interventions and better reporting on implementation factors to enhance their scalability across diverse settings.
+
+Little research has described characteristics of interventions targeted at cancer genomic services (CGS) among Latinos. This scoping review aimed to (1) describe interventions promoting uptake of CGS among Latinos in the United States and Latin America, (2) describe intervention adaptations for Latino participants, and (3) summarize intervention implementation factors suggested by reach, effectiveness, adoption, implementation, and maintenance (RE‐AIM) framework. We conducted a search in English and Spanish of literature published between 2005 and 2022 across PubMed and Latin American and Caribbean Health Sciences Literature databases.
+
+1 INTRODUCTION
+
+The Latino population in the United States (US) is diverse, consisting of members with ancestry from multiple countries. 1 Since 1970, the Latino population has grown more than sixfold and now makes up 19% (62.5 million individuals) of the national population. 2 Cancer is the leading cause of death among this group, accounting for 20% of deaths. 3 Earlier studies report that to non‐Hispanic Whites and Latinas have a higher incidence of triple‐negative breast cancer and are diagnosed at younger ages, factors that are associated with a higher likelihood of carrying hereditary genetic variants that increase cancer risk. 4 , 5 , 6 , 7 However, present research indicates that Latinas have a lower incidence and mortality rate of triple‐negative breast cancer compared with non‐Hispanic White women, suggesting that there are research gaps in knowledge surrounding hereditary cancer‐related incidence, mortality, and screening practices among Latinas. 8 , 9 , 10 Despite this, the uptake of family history screening, genetic counseling, and genetic testing among Latina women remains low, even in specialty settings. 11 , 12 , 13 As the Latino population continues to increase in the US, disparities in hereditary cancer‐associated cases and premature deaths will continue to widen. 2
+
+Cancer genomic services (CGS) can support risk management and reduce hereditary cancer‐related mortality. 14 , 15 These services have notable benefits particularly relevant to the Latino population. For example, brief family history assessments endorsed by national and public health organizations (e.g., United States Preventative Services Task Force [USPSTF] and Centers for Disease Control and Prevention [CDC]) now enable population‐based screening to identify families at high risk for BRCA‐associated cancers and Lynch syndrome (LS). 16 , 17 , 18 , 19 , 20 The National Comprehensive Cancer Network (NCCN) recommends genetic testing for patients diagnosed with colorectal cancer under the age of 50 and those with a personal history of tumor testing or a family history suggesting Lynch Syndrome. 21 Implementing cancer genetic screening is critical as individuals who carry a BRCA1/2 mutation have significantly increased lifetime risks for breast (50%–80%) and ovarian cancer (10%–40%), and individuals with LS have an increased lifetime risk of developing colorectal cancer (22%–74%), endometrial cancer (15%–71%), and ovarian cancer (4%–20%). 22 , 23 , 24 Potentially lifesaving prevention and treatment options are available to mutation carriers; thus, early detection is key to improvement of cancer outcomes (e.g., risk‐reducing surgeries, conventional chemotherapy, enhance screening). 5 , 23 , 24 However, Spanish‐preferring Latinas are half as likely as Whites to have discussed genetic counseling (GC) or genetic testing (GT) with a health provider. English‐preferring Latinas and Spanish‐preferring Latinas have greater odds of having unmet need for discussing GT with providers (OR = 2.44 and OR = 7.28, respectively). 25 Similarly, findings from a national health survey found that among those who reported completing GT, only 23% of Latinos reported completing GT for cancer screening compared 42% of non‐Hispanic White respondents. 26 The Hispanic Community Health Study, a longitudinal cohort study, found that only 3.3% of participants reported ever completing GT. 27 These findings demonstrate the underutilization of CGS among the Latino community. Efforts to expand CGS beyond urban cancer specialty settings that serve predominantly non‐Hispanic White populations have been exceedingly slow, which will likely lead to further worsening of health disparities. 28 , 29 , 30 , 31
+
+Various factors may contribute to the low uptake of CGS, such as cost, inadequate insurance coverage, lack of awareness on the part of the patient and/or provider, and limited availability of screening services. 32 Additionally, language barriers and immigration status may pose unique challenges for Latinos in accessing these screening services. While many Spanish‐speaking patients prefer language‐concordant GC, only 6% of US genetic counselors provide services in Spanish, and 60% use a bilingual medical interpreter. 33 , 34 , 35 Spanish‐preferring patients who receive GC in English or through interpreters have reported low hereditary breast and ovarian cancer knowledge, uncertainty about the purpose of testing, feeling overwhelmed, and inaccurate understanding of cancer risk and risk management options. 36 , 37 An analysis of the 2005 Health Information Trends Survey also found that individuals with immigrant status were less likely to report a family history of cancer, possibly resulting from fewer opportunities to learn about their family history due to separation from extended or immediate family members. 38 Providers may also forgo referring high‐risk Latinos to cancer‐related GC due to concerns about access, language, and cultural barriers, thus reducing opportunities for increasing awareness and knowledge about cancer risk and genetic screening among Latinos. 39 These barriers are partially associated with the community's level of acculturation—the degree to which the majority culture is adopted by a minority culture. 40 However, it is unclear to what extent existing strategies considered acculturation levels or made adaptations for the Latino community. While there is ample research that explores the individual‐level predictors (i.e., income, education level, etc.) for CGS attitudes and knowledge among minority groups, 41 , 42 , 43 it is unknown how many existing interventions have aimed to promote the uptake of CGS among Latinos. Understanding the characteristics of successful interventions geared toward Latino communities can facilitate the implementation of future interventions in broader settings and address persistent racial and ethnic inequities in CGS implementation, utilization, and access. 44
+
+RE‐AIM (reach, efficacy/effectiveness, adoption, implementation, maintenance) is an implementation framework designed to guide the planning and evaluation of programs to support program implementation in realistic settings. 45 Application of the RE‐AIM framework could facilitate systematic evaluation of intervention strategies implemented, with a special focus on implementation strategy adaptations and components that support intervention sustainability and scalability. 46 This scoping review aimed to (1) describe interventions to promote uptake of cancer‐related genomic services among Latino populations in the US and Latin America, (2) describe the extent to which these interventions have adapted to increase their fit for Latino community needs, and (3) summarize the components suggested by RE‐AIM implementation framework that are associated with potential scalability of these strategies.
+
+2 METHODS
+
+2.1 Study design
+
+A scoping review, informed by Arksey and O'Malley's scoping study framework, was performed as the research team anticipated a limited number of primary interventions reporting CGS interventions among Latino communities indicated by current racial/ethnic disparities in genetic databases. 47 A scoping review was conducted to map the existing body of evidence on interventions aimed to address this health disparity to highlight new ways of understanding it. 47 , 48 This paper utilizes the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines for reporting on scoping reviews. 49 The PRISMA strategy is outlined in Figure 1. The current scoping review did not involve human subjects and therefore was exempt from the IRB approval process.
+
+FIGURE 1 PRISMA flow diagram.
+
+2.2 Inclusion/exclusion criteria
+
+The present analysis included interventional designs to promote the uptake of CGS that occurred within the US and/or Latin America after September 2005 to capture the clinical interventions that occurred after the USPSTF recommendation that women whose family history is associated with an increased risk for deleterious mutations in BRCA1 or BRCA2 genes be referred for GC and evaluation for BRCA testing. Papers were included if they described evidence‐based interventions aimed at increasing the utilization of cancer genomic services, were conducted in the U.S. or Latin America, and were human studies that included participants that are identified or self‐identified as Latino/Hispanic.
+
+For the purposes of this study, cancer genomic services are defined as clinical services that include hereditary risk assessment of cancer, cancer genetic education or counseling, and cancer GT. 50 We defined ‘evidence‐based’ interventions as intervention strategies and methods informed by or derived from peer‐reviewed documented evidence (i.e., data‐based, research‐based, or scientifically‐based). Adaptations were defined as intentional modifications to achieve a better fit between an intervention and a new context, such as tailoring language, visuals, or literacy level. 51 , 52 We defined ‘intervention’ as a strategy or program to promote the uptake of cancer‐related genomic services. In this scoping review, Latino was defined as having origins or descent from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Uruguay, or Venezuela. 1 While additional gender‐neutral terms, such as Latinx and Latine may also describe this community, Latino is often used as a gender‐neutral option and is widely accepted by the community. 53 For the purposes of this study, acculturation measures included language fluency, language preference, immigration status, nativity, country of origin, and time/number of generations living in the US. 54 Lastly, the intervention levels assessed were patient, provider, and organization (none of which were mutually exclusive).
+
+Papers were excluded from the analysis if they were not written in English or Spanish, were not peer‐reviewed journal articles (including conference and meeting abstracts, commentaries, editorials, literature reviews, scoping reviews, and systematic reviews), performed tumor testing without direct patient involvement, conducted genetic screening/testing with the sole purpose of determining eligibility for a clinical trial, or did not provide full‐text access.
+
+3 SEARCH STRATEGY AND STUDY SELECTION
+
+Our search strategy (Appendix 1: Tables A1 and A2) was developed with the assistance of the library services of the Woodruff Health Sciences Center Library at Emory University. The PubMed search terms included free‐text and MESH terms for Latino (and terms that captured multiple nationalities and identities within the Latinx community), genetic screening, cancer, and cancer screening on PubMed.
+
+Our search terms were then adapted for the Latin American and Caribbean Health Sciences Literature (LILACS) database by translating the English search terms to Spanish. Due to the limitations in the search function in the LILACS database, researchers chose the broadest search terms to produce results relevant to the scoping review (cáncer y genética/o [cancer and genetics] and tumor y genética/o [tumor and genetics]). The scoping review included interventions published in English or Spanish published within September 2005 to September 2022.
+
+4 DATA EXTRACTION AND STUDY SELECTION
+
+Titles and abstracts were double‐screened for inclusion by two of five reviewers (D.R., Y.G., D.M., J.R.R., or L.F.). Remaining studies were single‐screened at full‐text review by one of three reviewers (D.R., Y.G., or D.M.). Discrepancies were resolved through discussion.
+
+The data extraction form was developed by the study team (D.R., Y.G.) and uploaded into the Covidence systematic review system. The research study characteristics extracted included authors, year of publication, country, study interventions to promote uptake of cancer‐related genomic services, intervention characteristics, study population, number of participants, and the main findings. The outcomes of interest included the uptake of genetic risk assessment (individuals who completed genetic risk screening/individuals who could have been screened), uptake of genetic education/counseling (individuals who completed GC services/individuals eligible for GC services), and uptake of GT (individuals who completed GT/individuals eligible for GT). 55 The acculturation measures identified in the previous section were also extracted. D.R., Y.G., and D.M. extracted qualitative and quantitative data based on the presence (1) or absence (0) of components for each RE‐AIM dimension (Table 3). Operationalization of each RE‐AIM dimension was informed by examples listed on the RE‐AIM website (https://re‐aim.org/learn/what‐is‐re‐aim/) and previous applications of the framework in health‐related systematic reviews. 55 , 56 , 57 Frequency counts and percentages were recorded for each RE‐AIM component, and means were calculated for each RE‐AIM indicator using Microsoft Excel 365.
+
+The study team (D.R., D.M., Y.G.) pilot tested the data extraction form with three studies and reached consensus among coders for each article. The lead author (DR) independently coded the rest of the eligible studies. The study team (D.R., D.M., Y.G.) met regularly to resolve any coding discrepancies and operationalize the RE‐AIM framework.
+
+5 QUALITY ASSESSMENT
+
+Rigor was assessed using the Effective Public Health Practice Project's Quality Assessment Tool for Quantitative Studies, chosen due to the tool's validity and reliability in assessing observational and experimental interventions. 58 , 59 Criteria assessed for study quality include study design, data collection methods, withdrawals, intervention integrity, and analyses.
+
+6 RESULTS
+
+6.1 Study characteristics
+
+Of the 576 search results produced in the PubMed parent scoping review, only 16 met the inclusion criteria. Of the 3260 search results produced in LILACS, 1768 papers remained after duplicates were removed, and 0 met the inclusion criteria. Table 1 summarizes the descriptive characteristics of the included interventions (n = 16). Most interventions took place within the US (n = 13), 12 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 and the remaining interventions were conducted in Latin American countries, including Brazil (n = 2) 72 , 73 and Mexico (n = 1). 74 Of the 16 interventions included, 14 (87.5%) of the interventions were evidence‐based 12 , 60 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 71 , 72 , 73 , 74 and 2 (12.5%) interventions were not evidence‐based. 61 , 70 The most frequently hereditary cancer syndromes were hereditary breast and ovarian cancer (n = 14, 77.8%), 12 , 60 , 61 , 63 , 64 , 65 , 66 , 67 , 69 , 70 , 71 , 72 , 73 , 74 Lynch syndrome (n = 6, 37.5%) 61 , 64 , 68 , 70 , 72 , 73 and melanoma (n = 2, 12.5%). 62 , 64 Various studies reported a study sample that was predominately highly educated (n = 6, 37.5%), 60 , 62 , 63 , 64 , 67 , 70 had limited knowledge regarding genetic risk and testing (n = 4, 25.0%), 61 , 63 , 71 , 74 had completed mammogram screening (n = 3, 18.8%), 12 , 60 , 67 had a personal (n = 3, 18.8%) 12 , 71 , 74 or family history (n = 2, 12.5%) 65 , 72 of cancer, or lacked health insurance coverage (n = 2, 12.5%). 28 , 68 Five (31.3%) were cross‐sectional interventions, 12 , 60 , 61 , 72 , 73 4 (25.0%) interventions were randomized controlled trials, 62 , 63 , 66 , 71 3 (18.8%) were cohort studies, 65 , 68 , 69 2 (12.5%) were non‐randomized experimental interventions, 67 , 70 1 was a case–control study, 64 and 1 (6.3%) was a mixed‐methods study. 74 A detailed summary of each intervention and its characteristics can be found in Table 1.
+
+TABLE 1 Summary and characteristics of included studies.
+
+Study	Design description	Screened hereditary cancer syndromes	RE‐AIM dimensions	Quality assessment	
+Reach	Effectiveness	Adoption	Implementation	Maintenance	
+Abul‐Husn et al., 2021, USA 61	Cross‐sectional study No control group
+
+	HBOC, LS, familial hypercholesterolemia (FH), Hereditary transthyretin amyloidosis (hATTR)	N = 74
+
+Male: 13 (17.4%); Female: 61 (82.4%);
+
+Mean age: 58 years
+
+Age range: 28–83 years
+
+Latino: 31%
+
+	GRA: N/A
+
+GC: 95%
+
+GT: 100%
+
+Other outcomes: Evaluated characteristics of participants who opted to receive their results.
+
+	Program was adopted by genetic counselors and Spanish translators at a university medical center.	Adaptations: patient‐level; Spanish translators were available for patients and language preference was measured.
+
+Piloted the return of results to patients prior to complete implementation of the program.
+
+Barriers: outdated patient contact information and patients leaving the health system.
+
+	N/A	Weak	
+Anderson et al., 2015, USA 60	Cross‐sectional study No control group
+
+	HBOC	N = 243
+
+Age range: 25–69 years
+
+Female: 100%
+
+Latino: 26.2%
+
+	GRA: 100%
+
+Latino GRA: 100%
+
+GC: N/A
+
+GT: N/A
+
+Other outcomes: Evaluated characteristics of women who did not want to discuss individualized risk results
+
+	Delivered by 2 research staff members in 2 federally qualified health centers.	Adaptations: provider‐level; Breast Cancer Risk Screening tool was created using the Gail model, the Claus model, and pedigree assessment tool to evaluate FH for HBOC risk.
+
+Training: Research staff received a 4‐hour tool‐specific training.
+
+	N/A
+
+	Weak	
+Blazer et al., 2021, Mexico 74	Mixed methods study No control group
+
+	HBOC	N = 1321
+
+Male: 17 (1%); Female: 1304 (99%)
+
+Latino: 100%
+
+Varying healthcare coverages (private, no coverage, and national program coverage)
+
+	GRA: 100%
+
+GC: N/A
+
+GT: 100%
+
+Other outcomes: Evaluated implementation of low‐cost BRCA testing program and genomic cancer risk provider knowledge
+
+	Delivered in four clinic settings (1 university, 2 cancer centers, 1 hospital) by 11 staff members (6 geneticists, 2 oncologists, 1 gynecologist, 1 general physician, 1 genetic laboratory clinician).	Adaptations: patient‐ and provider‐levels; Spanish translations for consent and protocol documents, roundtable discussions conducted in Spanish.
+
+Training: genomic cancer risk, case report forum, patient cancer risk questionnaire
+
+Piloted program in one location before expanding to the other three.
+
+Cost: $20 BRCA testing per case
+
+Facilitators: clinics engaging in site visits from the research team.
+
+Barriers: English language educational materials for clinicians with Spanish‐language preference, health care finance, adequately trained workforce, and population‐based registries in Mexico, cost for supplies, sample storage, support staff, and shipping
+
+	All physicians who received training continued to conduct GCRA. One site trained additional clinicians for more sustained services. Some clinicians left their institutions to implement GCRA services at other institutions.
+
+	Weak	
+Campacci et al., 2017, Brazil 72	Cross‐sectional study Risk survey was administered in person, over the telephone, or via letter
+
+	HBOC, LS	N = 20,000
+
+Age range: 18–79 years
+
+Average age: 51 ± 9.45 years
+
+Female: 100%
+
+Latino: 100%
+
+	GRA: 100%
+
+GC: N/A
+
+GT: N/A
+
+Other outcomes: Create and validate the primary screening questionnaire (PSQ) to identify people with risk for hereditary cancer predisposition syndrome
+
+	Delivered by nurses with experience in cancer genetics in 12 mobile units across 381 cities and in a cancer hospital.	Adaptations: patient‐level; educational materials were written in simple language for comprehension and materials were provided in Portuguese.
+
+	N/A
+
+	Weak	
+Conley et al., 2021, USA and Puerto Rico 71	Randomized controlled trial Intervention: culturally targeted educational booklet about GC/GT
+
+Control: BC survivorship fact sheet
+
+	HBOC	N = 52
+
+Average age: 54 ± 9 years
+
+Female: 100%
+
+Latino: 100%
+
+Born in Puerto Rico: 56%
+
+Born in Columbia: 21%
+
+Born in Cuba: 17%
+
+	GRA: 78.8%
+
+GC ○ Intervention: 65%
+
+○ Control: 15%
+
+GT ○ Intervention: 94%
+
+○ Control: 100%
+
+Other outcomes: Pre/post HBOC knowledge and emotional distress
+
+	Delivered by researchers and genetic counselors at a cancer center in the USA and a university research center in PR.	Adaptations: patient‐level; educational booklet was adapted from a brief English brochure about GC/GT with additional content regarding GC (definition, process, and benefits) and GT (process, timeframe, and financial aid resources); booklet was translated into Spanish.
+
+Barriers: low provider referral and patient awareness, limited access, and language and cultural barriers to genetic services.
+
+Facilitators: scheduling GT and follow‐up
+
+	N/A
+
+	Moderate	
+Hay et al., 2018, USA 62	Randomized controlled trial Intervention: MC1R test offer
+
+Control: usual care
+
+	MC1R (melanoma risk)	N = 499
+
+Age range: 19–85 years
+
+Mean age: 54 years
+
+Male: 103 (21%); Female: 376 (79%)
+
+Latino: 48.5%
+
+	GRA: N/A
+
+GC: 46.49%
+
+Latino GC: 38.4%
+
+GT: 33.5%
+
+Latino GT = 23.1%
+
+Other outcomes: Prevalence and interest in MC1R testing in diverse primary care population
+
+	Delivered by bilingual project assistants at a university medical center.	Adaptations made at the patient‐level; recruitment materials were translated into Spanish; printed version of the website content was provided to patients without internet access.
+
+Barriers include lack of knowledge, lower genomic literacy, and lack of confidence in the medical system.
+
+	N/A
+
+	Moderate	
+Kukafka et al., 2022, USA 63	Randomized controlled trial Intervention: decision aid for patients and clinicians
+
+Control: patient education
+
+	HBOC	N = 187
+
+Age range: 21–75 years
+
+Female: 100%
+
+Latino: 46.6%
+
+Can consent in English or Spanish
+
+	GRA ○ Intervention: 99.0%
+
+○ Control: 100%
+
+GC ○ Intervention: 19.8%
+
+○ Control: 11.6%
+
+GT ○ Intervention: 36.6%
+
+○ Control: 24.4%
+
+	Delivered at an academic medical center by research team and included 67 clinicians.	Adaptation: patient‐level; consent and patient education materials translated into Spanish.
+
+Decision aid and risk navigation tool were pilot tested among ethnically diverse women at high‐risk for BC.
+
+	N/A
+
+	Moderate	
+Lee et al., 2005, USA 64	Case–control study	HBOC, LS, melanoma	N = 7316
+
+Female: 100%
+
+Non‐English speaking: 25%
+
+Latino: 26%
+
+	GRA: N/A
+
+GC: 26%
+
+GT: 27%
+
+Other outcomes: Demographic characteristics of participants and effective patient recruitment methods
+
+	Delivered by a genetic counselor, a part‐time physician, and a clerk at a public health hospital.	Adaptations: patient‐ and organization‐levels; FH questionnaire was translated into Russian, Chinese and Spanish; survey was revised to include additional questions about other cancers in family, Ashkenazi Jewish ancestry, and permission for direct contact if patient did not have a PCP.
+
+Training: in‐service education on GC and BRCA testing for hereditary cancers
+
+Barriers: provider education, patient recruitment, assembly of a multidisciplinary team, and adapting genetic education to a population with marginal health literacy.
+
+	N/A
+
+	Weak	
+McGuinness et al., 2019, USA 12	Cross‐sectional study No control group
+
+	HBOC	N = 3055
+
+Age range: 29–91 years
+
+Mean age: 58 years
+
+Female: 100%
+
+Latino: 76.7%
+
+	GRA: 85.9%
+
+Latino GRA: 90.3%
+
+GC: N/A
+
+GT: 4.6%
+
+	Delivered by research team at an academic medical center.	Adaptation: patient‐level; Created 10‐question assessment using Gail model to assess eligibility for HBOC GT.
+
+Inclusion criteria specified participants could speak Spanish. No mention of translating services used.
+
+Barriers: limitations of current FH guidelines in identifying women who would benefit from GC/GT services for HBOC.
+
+	N/A
+
+	Weak	
+Mette et al., 2016, USA 70	Non‐randomized experimental study Video teleconferencing vs. in person GC
+
+	HBOC, LS	N = 353
+
+Age ≥ 50 years: 58%
+
+Latino: 56.6%
+
+English‐preferring: 84%
+
+	GRA: 100%
+
+GC: 100%
+
+GT: 79.8%
+
+Other outcomes: Compare effectiveness of telemedicine and in person delivery models on genetic risk assessment and GC education.
+
+	Delivered in four clinic settings by healthcare providers, genetic counselors, and oncologists.	Adaptation: patient‐level; genetic risk training was provided to healthcare providers; survey instrument was translated into Spanish and adapted to be accessible to patients with low literacy levels; language preference was measured, and the intervention was conducted in English and Spanish.
+
+Training: staff from 4 clinics received education on genetic services
+
+Patient satisfaction surveys were used to assess implementation.
+
+Facilitators: GC videoconferencing to Texas‐Mexico border
+
+Barriers: cost of services, limited accessibility of medical history due to language barriers, and under use of health services.
+
+	N/A	Weak	
+Nogueira et al., 2021, Brazil 73	Cross‐sectional study No control group
+
+	HBOC, LS	N = 675
+
+Latino: 100%
+
+	GRA: N/A
+
+GC: N/A
+
+GT: 91%
+
+	Delivered by a psychologist, lab technician, administrative staff, oncogeneticist, and general geneticist in a clinic setting.	No adaptations made. Language used for intervention not specified.
+
+Training: clinicians were trained on FH screening and hereditary cancer referral.
+
+Costs: administrative analysts created a cost center to monitor resource use and prepare financial reports.
+
+Barriers: making the service financially sustainable and overcoming testing taboos.
+
+	Discussed 3 potential strategies to improve sustainability of the program.	Weak	
+Pasick et al., 2016, USA 66	Randomized controlled trial Intervention: phone call
+
+Control group: educational brochure
+
+	HBOC	N = 88
+
+Age range: 28–69 years
+
+Female: 100%
+
+Latino: 36.3%
+
+Foreign‐born: 25.0%
+
+	GRA: 100%
+
+GC ○ Intervention: 68.2%
+
+○ Control: 47.7%
+
+GT: 9.8%
+
+	Delivered by telephone information specialists. Individuals were referred to genetic counselors (GC).	Adaptation: patient‐ and organizational levels; Pedigree Assessment Tool to administer over the phone and mirrored EWC intake questions to fit capabilities of information specialist team (high school level education); offered GC in Spanish.
+
+Facilitators: having high school‐level education specialists screen callers and having a GC assistant conduct a follow‐up.
+
+	Mention of collaboration with Cancer Risk Program to screen women but status of funding for GC referrals after the study is unclear.	Moderate	
+Schonberg et al., 2020, USA 67	Non‐randomized experimental study Pre and post groups
+
+	HBOC	N = 337
+
+Age range: 40–49 years
+
+Female: 100%
+
+Mean age: 44.1 ± 2.9
+
+Latino: 9.2%
+
+	GRA: 19%
+
+GC: 6%
+
+GT: N/A
+
+Other outcomes: Examine the effect of providing women in their 40s and their PCPs with a 2‐page personalized BC risk report before a PC visit
+
+	Delivered by Primary Care Clinician (PCC) at a university PCP.	No adaptations made. Program delivery occurred at the patient‐level.
+
+Training: conversation aids required minimal training
+
+	N/A	Moderate	
+Snedden et al., 2020, USA 68	Cohort study 3 sequential cohorts of newly diagnosed patients with CRC (PRE, PERI, POST)
+
+	LS	N = 381
+
+PRE (N) = 272
+
+PERI (N) = 25
+
+POST(N) = 84
+
+Male: 230 (60.4%), Female: 151 (39.6%)
+
+Latino: 62.5%
+
+	GRA ○ PRE: 30.5%
+
+○ PERI: 64.0%
+
+○ POST: 58.3%
+
+GC ○ PRE: 46.7%
+
+○ PERI: 75.0%
+
+○ POST: 80.0%
+
+GT ○ PRE: 46.7%
+
+○ PERI: 75.0%
+
+○ POST: 80.0%
+
+	Delivered by gastroenterologists, medical oncologists, surgeons, and pathologists in a clinical setting. The pathologists were responsible for verbally requesting and confirming the order for testing.	Adaptations: organizational and provider‐level; implementation of the Universal Tumor Screening (UTS) algorithm. UTS designed to reflect IHC screening for patients.
+
+Training: printed and verbal education among all responsible providers
+
+Barriers: pathologists not adhering to implemented algorithm with complete compliance.
+
+	N/A
+
+	Weak	
+Soewito et al., 2022, USA 65	Retrospective cohort study GCs provided educational sessions to health providers and community groups near the TX‐MEX border. No control group
+
+	HBOC	N = 1595
+
+Age range: 18+ years
+
+Male: 224 (14%), Female: 1371 (86%)
+
+Latino: 80%
+
+Low SES, literacy, and educational attainment levels
+
+	GRA: N/A
+
+GC: 86%
+
+GT: 86%
+
+	Program delivered by Community Health Workers at the home clinic, locally on periodic outreach trips (occurring in 8‐week intervals), or through video‐teleconferencing.	Adaptations: patient‐level; Language preference was measured, and intervention was conducted in English and Spanish by CHWs; GC was conducted by phone when video‐teleconference sites were restricted.
+
+Program demonstrated equivalent patient satisfaction and outcomes in video‐teleconference vs. in person counseling.
+
+Barriers: challenges with VUS communication.
+
+Facilitators: video‐teleconferencing and telephone delivery during COVID‐19 pandemic.
+
+	N/A	Weak	
+Walker et al., 2021, USA 69	Historical control study Intervention: Genetic Testing Station (GTS)
+
+Control: traditional referral method
+
+	HBOC, pancreatic ductal adenocarcinoma (PDAC)	N = 223
+
+Mean age: 64.6 ± 12 years
+
+Male: 116 (52%), Female: 107 (48%)
+
+Latino: 5%
+
+Spanish‐preferring: 7 (3%)
+
+	GRA: 100%
+
+GC: 66%
+
+GT: 92%
+
+	Intervention occurred at 1 oncology clinic. Program delivered by Nurse Navigators (NN), New Patient Coordinators (NPC), Genetic Counseling Assistants (GCA), and Genetic Counselors (GC).	Adaptation: patient‐ and organizational level. Implemented GTS referral system.
+
+GT was supported by philanthropic funds at no cost to the patient.
+
+Barriers: required GC availability for patient referrals.
+
+Facilitators: introducing the concept of germline testing in advance of the initial clinic appointment to facilitate appointment scheduling.
+
+	N/A
+
+	Weak	
+Abbreviations: FH, family history; GC, genetic counseling; GRA, genetic risk assessment; GT, genetic testing; HBOC, hereditary breast and ovarian cancer; LS, lynch syndrome; PCP, primary care provider.
+
+6.2 Characteristics of the intervention
+
+Most interventions occurred at the patient‐level (n = 12, 75.0%), 12 , 61 , 62 , 63 , 64 , 65 , 66 , 69 , 70 , 71 , 72 , 74 followed by the organizational level (n = 6, 37.5%), 60 , 64 , 66 , 68 , 69 , 74 and the provider‐level (n = 4, 25.0%). 60 , 65 , 68 , 74 Seven interventions addressed multiple levels. 60 , 64 , 65 , 66 , 68 , 69 , 74 Of these interventions, 13 (81.25%) piloted the use of cancer risk assessment tools (electronic, printed, or administered via phone call), 12 , 60 , 61 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 74 12 (75.0%) provided educational materials on GC/GT, cancer, and genetic risk among providers and/or patients (outreach events, brochures, and in‐service trainings), 60 , 62 , 63 , 64 , 65 , 66 , 68 , 69 , 70 , 71 , 72 , 74 and 3 (18.75%) provided printed individualized cancer risk results to patients. 60 , 61 , 67
+
+6.3 Strategies to address acculturation
+
+Most interventions considered acculturation issues to some extent during their design and implementation phases (n = 11, 68.8%). 61 , 62 , 63 , 64 , 65 , 66 , 69 , 70 , 71 , 73 , 74 As seen in Figure 2, common strategies to address acculturation include use of translation services (n = 10, 62.5%), 61 , 62 , 63 , 64 , 65 , 66 , 70 , 71 , 73 , 74 measuring language preference (n = 7, 43.8%) 61 , 63 , 65 , 69 , 70 , 71 , 74 or fluency (n = 3, 18.8%), 62 , 66 , 74 and documenting nativity (n = 2, 12.5%) 62 , 71 and country of origin (n = 1, 6.3%). 74
+
+FIGURE 2 Number of interventions reporting acculturation measures (n = 16).
+
+6.4 RE‐AIM dimensions
+
+Table 3 summarizes the number and percentage of interventions reporting each RE‐AIM dimension and component. The most reported dimensions of the implementation framework were reach (69.8%) and efficacy (70.9%). The least reported dimension of the framework was maintenance (10.4%).
+
+6.5 Reach
+
+Baseline sample sizes ranged from 52 to 20,000 (median = 359) participants. All interventions reported the proportion of Latino/a participants (range = 5%–100%). Most interventions reported characteristics such as sex (n = 15, 93.8%) 12 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 71 , 72 , 74 and age range (n = 10, 62.5%). 12 , 60 , 61 , 62 , 63 , 65 , 66 , 67 , 69 , 72 Some reported characteristics such as language literacy and language preference. Eight (50.0%) interventions only targeted female patients and screened for hereditary breast and ovarian cancer syndrome. 12 , 60 , 63 , 64 , 66 , 67 , 71 , 72
+
+All interventions reported their methods for identifying the target population for the intervention and sample size (n = 16, 100%), and most interventions outlined their inclusion criteria (n = 15, 93.8%) 12 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 74 and participation rate (n = 10, 62.5%). 12 , 60 , 61 , 62 , 63 , 66 , 67 , 69 , 70 , 74 Patients were recruited through an electronic health record 61 , 68 , 73 or registry, 68 , 71 recruiting in clinic settings 12 , 60 , 62 , 63 , 64 , 65 , 69 , 71 , 72 , 74 or outreach events, 71 by patient referral, 70 , 73 by mail, 67 or through a call center. 66 Few interventions, however, outlined their exclusion criteria (n = 4, 25.0%) 62 , 67 , 68 , 69 or the characteristics of individuals who refused to participate (n = 6, 37.5%). 60 , 62 , 63 , 66 , 68 , 69 The reach dimension had an overall reporting proportion of 69.8%.
+
+6.6 Efficacy/effectiveness
+
+Of the 16 interventions included, the uptake rate of genetic risk assessment screening was available for 10 (62.5%) interventions (uptake rate range: 19%–100%). 12 , 60 , 63 , 66 , 67 , 68 , 69 , 70 , 71 , 72 Three additional studies completed genetic risk screening but did not provide information on how many participants could have been screened. 64 , 73 , 74
+
+Eleven interventions (68.8%) reported the uptake rate of GC/education (range: 6%–95%). 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 Four additional interventions reported how many patients were eligible for GC/education; however, they did not report how many participants completed GC. 60 , 72 , 73 , 74
+
+Thirteen interventions (81.3%) reported the uptake rate of GT (uptake rate range: 4.6%–100%). 12 , 61 , 62 , 63 , 64 , 65 , 66 , 68 , 69 , 70 , 71 , 73 , 74 Three interventions did not measure GT uptake as an intervention outcome. 60 , 67 , 72 Overall, 70.9% of the efficacy/effectiveness domain was reported by the interventions included in the review. Assessing the uptake of CGS among Latinos is challenging as only five studies reported uptake of genetic risk assessment among Latinos. 12 , 60 , 71 , 72 , 74 Two studies reported uptake of GC among Latinos, 62 , 71 and four reported uptake of GT among Latinos. 62 , 71 , 73 , 74
+
+6.7 Adoption
+
+All interventions (n = 16, 100.0%) provided a description of the intervention location. Most interventions (n = 11, 68.8%) occurred in one site location 12 , 60 , 61 , 62 , 63 , 64 , 65 , 67 , 69 , 70 , 72 and 5 (31.3%) occurred across multiple site locations. 66 , 68 , 71 , 73 , 74 Intervention settings included universities (n = 12, 75.0%), 12 , 61 , 62 , 63 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 74 oncology hospitals (n = 3, 18.8%), 72 , 73 , 74 cancer centers (n = 2, 12.5%), 71 , 74 primary care clinics (n = 2, 12.5%), 60 , 73 a national research center (n = 1, 6.3%), 74 a general hospital (n = 1, 6.3%), 64 and a state department of health (n = 1, 6.3%). 66 Fourteen interventions (87.5%) described the staff who delivered the intervention and their level of expertise. 60 , 61 , 62 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 Delivery agents include PCPs, GCs, nurses, community health workers, and research assistants with multiple years of experience. Of these 14 interventions, only 1 reported their method to identify the intervention delivery agent. 74 Three interventions (18.8%) reported the cost characteristics of the intervention implementation, such as the materials needed to complete GT, the cost of genetic tests, and printed educational materials. 71 , 73 , 74 None of the interventions included in the review reported the adoption rate of the intervention. Overall, the interventions included reported 48.0% of the components in the adoption dimension.
+
+6.8 Implementation
+
+All interventions (n = 16, 100%) reported the intervention type and intensity of the intervention. Seven interventions (43.8%) conducted training for the personnel delivering the intervention 60 , 63 , 67 , 68 , 70 , 72 , 73 and 2 (12.5%) interventions piloted health education materials prior to the start of the intervention. 71 , 74 Eleven interventions (68.8%) reported barriers to implementation, 12 , 61 , 62 , 64 , 65 , 68 , 69 , 70 , 71 , 73 , 74 the most common being lack of adequately trained workforce, financial barriers to GC/GT, lack of GT/GC knowledge among patients, limited family history knowledge, and language barriers. Only 6 (37.5%) interventions reported facilitators to implementation, 65 , 66 , 69 , 70 , 71 , 74 including reducing health literacy required to comprehend GT/GC educational materials and scheduling GT/GC appointments earlier in the intervention process. Most interventions (n = 7, 43.8%) delivered the intervention within the current workflow of the organization. 12 , 64 , 66 , 68 , 69 , 70 , 72 Six interventions (37.5%) reported the extent to which the protocol was delivered as intended 62 , 66 , 67 , 68 , 69 , 71 and 1 (6.3%) intervention reported the cost of implementation. 74 Most interventions (n = 14, 87.5%) made adaptations to the intervention. 12 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 68 , 69 , 70 , 71 , 72 , 74 Of these interventions, adaptions in 7(43.8%) addressed only one level of implementation, 12 , 61 , 62 , 63 , 70 , 71 , 72 6 (37.5%) addressed two levels, 60 , 64 , 65 , 66 , 68 , 69 and 1 (6.3%) addressed three levels (levels assessed: patient, provider, organization). 74 Most adaptations made were related to various measures of acculturation. Other adaptations included designing intervention materials that mirror current workflow of intervention setting (n = 4, 25.0%), 60 , 66 , 69 , 74 reducing required literacy of health education materials (n = 4, 25.0%), 66 , 70 , 71 , 74 incorporating changes to health education materials after piloting (n = 3, 18.8%), 64 , 70 , 71 and providing no‐/low‐cost GC/GT (n = 2, 12.5%). 69 , 71 Overall, the interventions reported an average of 49.2% components of the implementation dimension.
+
+6.9 Maintenance
+
+Of the 16 interventions, only 3 (18.8%) assessed intervention outcomes 6 months after the implementation 63 , 64 , 67 , 74 and 2 (12.5%) interventions reported the current status of the intervention. 73 , 74 One intervention reported an expansion of the program to other site locations and among other clinical practitioners. 74 Another intervention is exploring strategies to improve the sustainability of the program. 73 No intervention reported the cost associated with the maintenance of the program. Overall, the interventions reported an average of 12.5% of the components of the maintenance dimension.
+
+6.10 Quality assessment
+
+Based on the quality assessment tool criteria, 11 interventions (68.7%) were of weak quality, 12 , 60 , 61 , 64 , 65 , 68 , 69 , 70 , 72 , 73 , 74 5 interventions (32.3%) were of moderate quality, 62 , 63 , 66 , 67 , 71 and none of the included interventions were of strong quality (Table 2). The moderate‐quality interventions utilized a RCT and a pre‐/post‐cohort study design.
+
+TABLE 2 Descriptive characteristics of interventions.
+
+Studies (n = 16)	
+Country	
+USA	13 (81.3%)	
+Brazil	2 (12.5%)	
+Mexico	1 (6.3%)	
+Study design	
+Cross‐sectional study	5 (31.3%)	
+Mixed methods	1 (6.3%)	
+Randomized controlled trial	4 (25.0%)	
+Case–control study	1 (6.3%)	
+Non‐randomized experimental study	2 (12.5%)	
+Cohort study	3 (18.8%)	
+Quality rating	
+Strong	0	
+Moderate	5 (32.3%)	
+Weak	11 (68.7%)	
+Intervention setting	
+Academic institution	12 (75.0%)	
+Cancer center	2 (12.5%)	
+Oncology hospital	3 (18.8%)	
+Primary care clinic	2 (12.5%)	
+National research center	1 (6.3%)	
+General hospital	1 (6.3%)	
+State department of health	1 (6.3%)	
+Intervention level	
+Patient‐level	12 (75.0%)	
+Provider‐level	4 (25.0%)	
+Organization‐level	6 (37.5%)	
+Number of levels addressed in study	
+1	7 (43.8%)	
+2	6 (37.5%)	
+3	1 (6.3%)	
+Evidence‐based design	
+Yes	13 (81.3%)	
+No	2 (12.5%)	
+
+TABLE 3 Proportion of cancer‐related genetic service interventions among Latinos reporting RE‐AIM (n = 16 interventions).
+
+RE‐AIM Dimensions and Components	Proportion reporting	
+Reach	
+Method to identify target population	16 (100%)	
+Inclusion criteria	15 (93.8%)	
+Exclusion criteria	4 (25%)	
+Sample size	16 (100%)	
+Participation rate	10 (62.5%)	
+Characteristics of nonparticipants	6 (37.5%)	
+Average of overall reach dimension	69.8%	
+Efficacy/Effectiveness	
+Uptake of genetic risk assessment	10 (62.5%)	
+Uptake of genetic counseling and education	11 (68.8%)	
+Uptake of genetic testing	13 (81.3%)	
+Average of overall efficacy/effectiveness dimension	70.9%	
+Adoption	
+Description of intervention location	16 (100%)	
+Description of staff who delivered intervention	14 (87.5%)	
+Method to identify target delivery agent	1 (6.3%)	
+Level of expertise of delivery agent	14 (87.5%)	
+Adoption rate	0 (0%)	
+Characteristics of cost implementation	3 (18.6%)	
+Average of overall adoption rate	48.0%	
+Implementation	
+Intervention type and intensity	16 (100%)	
+Extent protocol delivered as intended (%)	6 (37.5%)	
+Measures of cost of implementation	1 (6.3%)	
+Conducted training courses for intervention delivery agents	7 (43.8%)	
+Piloted health education materials	2 (12.5%)	
+Reported facilitators to implementation	6 (37.5%)	
+Reported barriers to implementation	11 (68.8%)	
+Adaptation made for intervention	14 (87.5%)	
+Average of overall implementation dimension	49.2%	
+Maintenance	
+Assessed outcomes ≥6 months post‐intervention	4 (25%)	
+Current status of program	2 (12.5%)	
+Cost of maintenance	0 (0%)	
+Average of overall maintenance dimension	12.5%	
+
+7 DISCUSSION
+
+Few published interventions promoting the uptake of GC/GT services among Latino populations in the U.S. have been reported, and fewer in Latin America. CGS are rare in many Latin American countries, possibly because genetic counseling is not a formally recognized discipline in these countries, limited CGS expertise among healthcare professions, few genetic counseling training programs, and lack of CGS services among socioeconomically disadvantaged populations. 73 , 74 , 75 , 76 Of 2344 publications, 16 interventions (0.68%) conducted among Latino communities were published. Of these interventions, none were uniquely identified through LILACS or published in Spanish, highlighting the lack of CGS uptake research in Latin America.
+
+The most common intervention delivery method was incorporating an existing or modified family history‐based screening tool within the current clinic setting workflow. While most interventions addressed multiple levels, they primarily focused on the patient level (75%). Comparatively, a recent systematic review conducted across the U.S. population found that only 17 of 44 (39%) interventions designed to promote the uptake of CGS focused solely on the patient level. 77 The results of this review may be inconsistent with interventions conducted among the overall US population due to the prominence of acculturation‐informed intervention design in our review. To increase the fit of the intervention for Latino patients, 11 interventions included acculturation measures and adaptations to address language barriers in clinic settings and demonstrated higher uptake of CGS. These findings suggest that patient‐level implementation and adaptation may be uniquely necessary for communities that experience language barriers in health care settings. Future interventions may explore the role of acculturation measures at provider/organizational levels such as assessing the impact of cultural humility trainings on healthcare providers' cross‐cultural interactions, examining the availability and quality of translation services within healthcare organizations to assess communication and comprehension gaps, and implementing strategies to engage patients from diverse backgrounds in CGS uptake.
+
+Commonly applied acculturation‐informed strategies included use of translation services, measuring language preference and fluency, and documenting nativity and country of origin. However, important acculturation measures, such as immigration status and time/generations in the US, went unreported. These findings were consistent with prior literature in healthcare settings. 54 While considering language barriers is necessary to address gaps in uptake among the Latino community, it may also be valuable to consider less‐reported factors. For example, time/generations in the US and immigration status may provide important context for providers regarding patient knowledge of GC/GT and incomplete patient family history. 38 In this review, interventions 12 , 67 , 68 that did not implement adaptations to address varying levels of acculturation generally reported lower rates of uptake of CGS compared with the interventions 61 , 65 , 66 , 70 , 71 , 74 that implemented acculturation‐informed adaptations. Studies that did not report any language‐based adaptations 60 , 67 , 69 had much lower recruitment of Latinos in the study sample compared with interventions that did incorporate these adaptations. Inclusion of additional acculturation measures can inform the design of culturally relevant health education programs and interventions that account for the heterogeneity of the Latino population.
+
+Adapting established screening methods to current patient intake processes facilitated implementation and promoted adoption of screening tools among staff, regardless of educational background or expertise. There is promising evidence that implementing existing screening tools into current organizational workflows can promote the delivery and uptake of CGS. However, most interventions lacked maintenance details of the intervention, making the status of the program unclear. Additionally, there was a lack of reporting of intervention implementation factors that were associated with program scalability and sustainability. Future interventions may benefit from the application of an implementation framework, such as RE‐AIM, to ensure factors of scalability and sustainability are measured and reported. The use of implementation frameworks in intervention design can further our ability to reproduce interventions outside of academic institutions and reduce access to care barriers, which is essential to address the paucity of interventions aimed at the Latino community despite the broad and inclusive search conducted for the present scoping review.
+
+Regarding increasing access among Latino communities, the interventions showed varying success. Of the interventions included, 5 (31.25%) interventions had a sample that was 100% Latino, and 2 (12.5%) interventions included samples that were less than 25% Latino. Most interventions (n = 8, 50%) included exclusively female study populations. Interventions that addressed access barriers highlighted by Latino communities, such as cost, high participant burden, timeliness of care, and language barriers, showed high reach potential for CGS uptake. Existing research also highlights the importance of cultural factors, such as religion, in the formation of genetic fatalism beliefs. 78 Although the research base is limited, current literature suggest that creating culturally curated intervention strategies can facilitate the uptake of CGS among Latino communities by addressing perceived concerns and negative emotional effects. 78 Future research may focus on intentionally recruiting from Latino communities and measuring CGS uptake among men to improve intervention methods that benefit the community at large. Implementing the use of community‐based participatory research and transdisciplinary methods can further develop our knowledge base on addressing existing inequities in CGS by emphasizing mutual learning and minimizing bias. 79 , 80
+
+Our review has some limitations. Our analysis included all relevant interventions that reported inclusion of Latino participants, regardless of the proportion. As such, the findings of some interventions may not be applicable to Latino populations if the community was underrepresented in the study population. Additionally, many studies did not report characteristics that highlight the diversity of Latino study participants, thus limiting our ability to analyze uptake rates across ethnicities, language preference groups, or immigration statuses. Research focused on understanding or addressing racial/ethnic disparities in CGS should consider reporting uptake by such characteristics to identify hidden trends in large racial/ethnic groups. Despite these limitations, our review included literature searches in both English‐ and Spanish‐language databases to characterize interventions designed to promote the uptake of CGS among Latino communities in the US and Latin America. Acculturation‐informed adaptations may improve the fit of future interventions with the Latino community and promote the uptake of CGS services. The lack of consensus on the role acculturation plays on the health experiences of Latinos highlights the need for further explore acculturation‐informed intervention design and implementation to better understand how to operationalize acculturation and analyze its impact on health outcomes. Usage of the RE‐AIM framework showed that various measures of implementation are underreported, thus limiting application in other settings and scalability. Designing future interventions using implementation frameworks may improve intervention scalability of successful strategies and increase utilization of CGS services among Latino communities.
+
+AUTHOR CONTRIBUTIONS
+
+Dayanna Ramirez Leon: Conceptualization (lead); data curation (equal); formal analysis (lead); investigation (equal); methodology (equal); software (equal); visualization (lead); writing – original draft (lead); writing – review and editing (equal). Denise Martinez: Formal analysis (equal); validation (equal); writing – review and editing (equal). Jessica Rivera Rivera: Formal analysis (equal); validation (equal); writing – review and editing (equal). Lindsay Fuzzell: Formal analysis (equal); resources (equal); validation (equal); writing – review and editing (equal). Susan Vadaparampil: Methodology (supporting); resources (equal); writing – review and editing (equal). Hannah Rogers: Data curation (lead); resources (lead); software (equal); writing – review and editing (equal). Sheryl Gabram: Conceptualization (supporting); supervision (supporting); writing – review and editing (equal). Cindy Snyder: Conceptualization (supporting); supervision (supporting); writing – review and editing (equal). Yue Guan: Conceptualization (equal); formal analysis (equal); funding acquisition (lead); methodology (equal); project administration (equal); supervision (equal); validation (equal); writing – review and editing (equal).
+
+FUNDING INFORMATION
+
+PI (Guan) received a research grant from the Emory University Rollins School of Public Health Dean's Pilot and Innovation 2022 Grant to pay authors (Dayanna Ramírez and Denise Martinez) for the time spent preparing the manuscript.
+
+CONFLICT OF INTEREST STATEMENT
+
+No authors have conflict or interests to report.
+
+DATA AVAILABILITY STATEMENT
+
+All data and materials are available upon request (Dayanna Ramirez, dayanna.ramirez@emory.edu).
+
+APPENDIX 1 SEARCH STRATEGY
+
+TABLE A1 Search terms for PubMed.
+
+Concept	Specific search terms	
+Latine	(hispanic*[tiab] OR “hispanic american*”[tiab] OR “hispano*”[tiab] OR “latine*”[tiab] OR “latina*”[tiab] OR “latin”[tiab] OR “latinu*”[tiab] OR “latino”[tiab] OR “latinx*”[tiab] OR “latin american*”[tiab] OR “latin america”[Mesh] OR “spanish speak*”[tiab] OR “mexico*”[tiab] OR “Mexico”[Mesh] OR “cuban*”[tiab] OR “peruvian*”[tiab] OR “dominican*”[tiab] OR “brazilian*”[tiab] OR “central american*”[tiab] OR “costa rican*”[tiab] OR “guatemalan*”[tiab] OR “honduran*”[tiab] OR “uruguayan*”[tiab] OR “argentina”[Mesh] OR “argentine”[tiab] OR “argentinian”[tiab] OR “argentinean”[tiab] OR “panamanian*”[tiab] OR “salvadorean*”[tiab] OR “salvadoran*”[tiab] OR “salvadorian*”[tiab] OR “nicaraguan*”[tiab] OR “south america*”[tiab] OR “bolivian*”[tiab] OR “chilean*”[tiab] OR “Chile”[Mesh] OR “colombian*”[tiab] OR “ecuadorian*”[tiab] OR “paraguay*”[tiab] OR “Paraguay”[Mesh] OR “venezuelan*”[tiab] OR “puerto rican*”[tiab] OR “puerto rico*”[tiab] OR “Puerto Rico”[Mesh] OR “spanish america*”[tiab] OR “boricua*”[tiab] OR “chicana*”[tiab] OR “chicano”[tiab] OR “Hispanic or Latino”[Mesh] OR “latinoamerican*”[tiab] OR “Mexican Americans”[Mesh] OR “spanish caribbean*”[tiab] OR “mexican american*”[tiab])	
+AND	
+Cancer	(“Neoplasms”[Mesh] or neoplasm*[tw] or cancer*[tw] or tumor*[tw] or tumor*[tw] or malignan*[tw])	
+AND	
+Genetic screening	((genetic[tw] or genetics[tw]) and (screening*[tw] or “Mass Screening”[Mesh])) OR “Genetic Testing”[Mesh] OR “Genetic Carrier Screening”[Mesh]	
+AND	
+Publication date	(2005/1/1:2022/8/10[pdat])	
+
+TABLE A2 Search terms for Latin American and Caribbean Health Sciences Literature (LILACS).
+
+Concept	Specific search terms	
+Cancer	cáncer o tumor	
+AND	
+Genetics	genética/o	
+
+
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+76 Cruz‐Correa M , Pérez‐Mayoral J , Dutil J , et al. Clinical cancer genetics disparities among Latinos. J Genet Couns. 2017;26(3):379‐386. doi:10.1007/s10897-016-0051-x 27957667 PMC5418082
+77 Bednar EM , Nitecki R , Krause KJ , Rauh‐Hain JA . Interventions to improve delivery of cancer genetics services in the United States: a scoping review. Genet Med. 2022;24(6):1176‐1186. doi:10.1016/j.gim.2022.03.002 35389342 PMC12234025
+78 McKinney LP , Gerbi GB , Caplan LS , Claridy MD , Rivers BM . Predictors of genetic beliefs toward cancer risk perceptions among adults in the United States: implications for prevention or early detection. J Genet Couns. 2020;29(4):494‐504. doi:10.1002/jgc4.1228 32103577 PMC8364329
+79 Rebbeck TR , Bridges JFP , Mack JW , et al. A framework for promoting diversity, equity, and inclusion in genetics and genomics research. JAMA Health Forum. 2022;3(4):e220603. doi:10.1001/jamahealthforum.2022.0603 35755401 PMC9223088
+80 Berger‐González M , Stauffacher M , Zinsstag J , Edwards P , Krütli P . Transdisciplinary research on cancer‐healing systems between biomedicine and the Maya of Guatemala: a tool for reciprocal reflexivity in a multi‐epistemological setting. Qual Health Res. 2016;26(1):77‐91. doi:10.1177/1049732315617478 26679941
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Womens Health
+Journal ID: BMC Womens Health
+NLM Journal ID: 101088690
+
+BMC Women's Health
+
+EISSN: 1472-6874
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC10629088
+PMID: 37932747
+DOI: 10.1186/s12905-023-02735-z
+Article ID: 2735
+Article version: 1
+Subjects: Research
+
+Implementation strategies, facilitators, and barriers to scaling up and sustaining demand generation in family planning, a mixed-methods systematic review
+
+http://orcid.org/0000-0003-4572-2210 Nabhan Ashraf anabhan@med.asu.edu.eg
+1
+Kabra Rita 2
+Ashraf Alyaa 3
+Elghamry Fatma 3
+Kiarie James 2
+Family Planning Research Collaborators Atwa Emry Bahnasy Samhaa Elgendi Marwa Elshabrawy Amal Eltayeb Salma Galal Sara Kodsy Mariam Makram Nada Mostafa Nourhan Sakna Noha Salama Mohamed Snosi Marwa Wagih Nouran Zenhom Ahmed 3
+1 https://ror.org/00cb9w016 grid.7269.a 0000 0004 0621 1570 Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University, Ramses Street, Cairo, Egypt
+2 https://ror.org/01f80g185 grid.3575.4 0000 0001 2163 3745 Department of Sexual and Reproductive Health including UNDP/UNFPA/ UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland
+3 https://ror.org/00cb9w016 grid.7269.a 0000 0004 0621 1570 Faculty of Medicine, Ain Shams University, Cairo, Egypt
+Electronic publication date: 2023 Nov 7
+Publication date: 2023
+Volume: 23
+Electronic Location ID: 574
+Received 2023 Jan 27; Accepted 2023 Oct 26
+Copyright: © The Author(s) 2023
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Family planning, Demand generation, Scaling-up
+
+Funding: World Health Organization,Switzerland 2022/1240770-0
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2023
+
+Ÿ==============================Ÿ
+Background
+
+Demand generation aims to increase clients’ desire to use family planning. The aim of this work was to systematically summarize strategies, facilitators, and barriers to scaling up and sustaining demand generation in family planning.
+
+Methods
+
+We searched electronic bibliographic databases from inception to October 2022. We included quantitative, qualitative, and mixed methods reports on demand generation strategies in family planning, regardless of country, language, publication status, or methodological limitations. We assessed abstracts, titles and full-text papers according to the inclusion criteria, extracted data, and assessed methodological quality of included reports. We used the convergent integrated approach and a deductive thematic synthesis to summarize demand generation themes and subthemes. We used the health system building blocks to synthesize the factors affecting implementation (barriers and facilitators). We used GRADE-CERQual to assess our confidence in the findings.
+
+Results
+
+Forty-six studies (published 1990–2022) were included: forty-one quantitative, one qualitative, and four mixed methods). Three were from one high-income country, and forty three from LMIC settings. Half of reports were judged to be of unclear risk of bias. There were unique yet interrelated strategies of scaling-up demand generation for family planning. Interpersonal communication strategies increase adoption and coverage of modern contraceptive methods, but the effect on sustainability is uncertain. Mass media exposure increases knowledge and positive attitudes and may increase the intention to use modern contraceptive methods. Demand-side financing approaches probably increase awareness of contraceptives and the use of modern contraceptive methods among poor clients. Multifaceted Demand generation approaches probably improve adoption, coverage and sustainability of modern methods use. Factors that influence the success of implementing these strategies include users knowledge about family planning methods, the availability of modern methods, and the accessibility to services.
+
+Conclusions
+
+Demand generation strategies may function independently or supplement each other. The myriad of techniques of the different demand generation strategies, the complexities of family planning services, and human interactions defy simplistic conclusions on how a specific strategy or a bundle of strategies may succeed in increasing and sustaining family planning utilization.
+
+Trial Registration
+
+Systematic review registration: Center for Open Science, osf.io/286j5
+
+Family planning could prevent one third of maternal deaths by allowing women to delay motherhood, avoid unintended pregnancies and subsequent abortions. Demand generation is one of the critical factors for increasing coverage and sustainability of family planning programs. Demand generation activities aim to increase clients’ desire to use family planning by changing their attitudes or perceptions about FP or increasing their awareness or knowledge about FP methods and also by improving access to contraceptive services. Many demand generation activities also aim to shift social and cultural norms to affect individual behavior change. Scaling up demand generation and ensuring that demand for family planning is satisfied is essential for achieving universal access to reproductive health-care services. We systematically searched for and summarized reports of strategies to scale up demand generation for family planning. Available evidence shows that interpersonal communication strategies increase adoption and coverage of modern contraceptive methods, but the effect on sustainability is uncertain. Mass media exposure increases knowledge and positive attitudes and may increase the intention to use modern contraceptive methods. The effect of new media is uncertain. Demand-side financing approach probably increase awareness of contraceptives and the use of modern contraceptive methods among poor women. The most apparent factors influencing the success of implementing these strategies include knowledge about family planning methods, especially regarding side effects and health concerns, the availability of modern contraceptive methods, and the accessibility to family planning services.
+
+Background
+
+Improving the effectiveness of family planning (FP) programs is critical for empowering women and adolescent girls, improving human capital, reducing dependency ratios, reducing maternal and child mortality, and achieving demographic dividends particularly in low- and middle-income countries. Family planning could prevent one third of maternal deaths by allowing women to delay motherhood, avoid unintended pregnancies and subsequent abortions [1, 2].
+
+One of the driving forces for increasing coverage and sustainability of family planning programs is demand generation. Demand generation strategies encompass three categories: interpersonal communications, mass media, and innovative financing approaches. Demand generation activities aim to increase clients’ desire to use family planning by changing their attitudes or perceptions about FP or increasing their awareness or knowledge about FP methods and also by improving access to contraceptive services. Many demand generation activities also aim to shift social and cultural norms to affect individual behavior change [3, 4].
+
+Implementing demand generation strategies and ensuring that demand for family planning is satisfied are essential for achieving universal access to reproductive health-care services, as called for in the 2030 Agenda for Sustainable Development [5]. Scaling up is defined as deliberate efforts to increase the impact of health service innovations successfully tested in pilot or experimental projects so as to benefit more people and to foster policy and program development on a lasting basis [6–9].
+
+Therefore, as part of its family planning strategy, the WHO has commissioned this systematic review of scaling up demand generation in family planning.
+
+The overall aim of the review was to describe and assess the quality of the evidence on scaling up demand generation in family planning. The review has the following objectives:
+
+to identify, appraise and synthesize research evidence regarding the approaches or strategies to scale up demand generation in FP for improving adoption, coverage, and sustainability;
+
+to identify, appraise and synthesize research evidence on the barriers to and facilitators of scaling up demand generation for family planning.
+
+Methods
+
+We conducted a systematic review, following the JBI methodology for mixed methods systematic reviews (MMSR) [10] and methods suggested by the Cochrane Effective Practice and Organisation of Care (EPOC) Review Group [11].
+
+The protocol, available as a preprint [12], was registered in the Center for Open Science platform (10.17605/OSF.IO/286J5).
+
+We reported the review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [13].
+
+Criteria for considering studies for this review
+
+Types of participants
+
+We included all types of participants who are the target of scaling up demand generation for FP.
+
+Phenomena of interest
+
+We included studies where the focus is scaling up demand generation for FP.
+
+Types of interventions
+
+For this review, we considered demand generation strategies under the following categories: interpersonal communications, mass media, and innovative financing approaches [3].
+
+Outcomes
+
+We considered implementation research outcomes mainly adoption (the intention, initial decision, or action to try to employ an intervention; also known as Uptake, Utilization, Intention to use), coverage (the degree to which the population that is eligible to benefit from an intervention actually receives it), and sustainability (the extent to which an intervention is maintained; also known as maintenance, Continuation) [14, 15].
+
+Barriers and facilitators (factors that influence demand generation)
+
+The approach to the factors affecting demand generation to scale up FP was based on the SURE (Supporting the Use of Research Evidence) framework [16]. We considered the factors affecting implementation at all levels namely recipients of care, providers of care, other stakeholders (including other healthcare providers, community health committees, community leaders, program managers, donors, policymakers and opinion leaders), health system constraints, and social and political constraints.
+
+The factors were finally grouped by the categories of health system building blocks (HSBB). HSBB is an analytical framework used by WHO to describe health systems, disaggregating them into 6 core components, with people in the center, (i) service delivery, (ii) health workforce, (iii) health information systems, (iv) Medical products, vaccines and technologies (access to essential medicines), (v) financing, and (vi) leadership and governance [17].
+
+Types of studies
+
+We included primary quantitative studies, qualitative studies, process evaluation studies, policy analysis studies, and case studies. Mixed method studies were only considered if data from the quantitative or qualitative components can be clearly extracted.
+
+We excluded editorials, commentaries, proposals, conference abstracts and systematic reviews. We also excluded reports that lacked a clear methodology section.
+
+There was no restriction on length of study follow-up, language of publication, or country of origin.
+
+Literature search
+
+Sources
+
+The search strategy aimed to locate both published and unpublished studies. We searched bibliographic databases for peer reviewed publications as well as grey literature. We searched the following electronic bibliographic databases (from inception to 15th September 2022): MEDLINE, PubMed, Scopus, the Cochrane Library, and Global Index Medicus, World Health Organization (www.globalindexmedicus.net).
+
+We also searched gray literature using the search engines and websites of relevant organizations. We hand searched citations in included articles.
+
+Search strategy
+
+The search terms were developed in consultation with the other authors using a combination of keywords and Medical Subject Headings (MeSH). The search strategy will be first developed in Pubmed format and was adapted to the other databases. The search strategies for various platforms are available in an open access repository [18].
+
+We will use the following terms ((Implementation Science[MeSH Terms]) OR (“Health Services Needs and Demand”[MeSH Terms]) OR (“demand generation” [Text Word]) OR (“demand side” [Text Word])) AND ((Family Planning Services[MeSH Terms]) OR (contraception[MeSH Terms]) OR (contracept*[Text Word]) OR (“family planning”[Text Word]) OR (“birth control”[Text Word]) OR (“birth spacing”[Text Word])). We aimed at sensitivity rather than precision since we opted to minimize false negative results.
+
+Management of search results
+
+All search results were imported into Jabref v5. Duplicate search results were identified by the software and were eliminated after being revised by the authors, using a method that enables retaining unique citations without accidentally excluding false duplicates.
+
+Data collection
+
+Study selection
+
+We developed a study selection form based on our eligibility criteria. After removal of duplicates, two review authors independently piloted the study selection form with a small random sample of studies to assess understanding of eligibility criteria and ease of use of the form. Two review authors independently screened all titles/abstracts and full text to identify the relevant studies. Discrepancies between review authors regarding study eligibility were resolved by consensus or, when required, with a third party. We used the PRISMA flowchart to describe the process of study selection.
+
+Data extraction
+
+Two review authors independently extracted characteristics from the included studies: study title, first author, year of publication, country of study, the country’s economic status (low-, middle-, or high-income), study type and design. We extracted the demand generation strategies mentioned in each study, the target of the demand generation activity, implementation outcome evaluated in each study, and barriers and facilitators. We resolved any disagreement in the data collection process through discussion and consensus between the two reviewers and, if needed, with a third party.
+
+Quality assessment
+
+For each included study, the methodological quality were described using the corresponding Mixed-Methods Appraisal Tool (MMAT) criteria [19, 20]. Two independent reviewers assessed the quality of included studies using MMAT, with a third independent reviewer to be used in case of any discrepancies. We accepted that there is no ‘gold standard’ approach for assessing the methodological quality of primary qualitative studies, but believe that MMAT fits the context of this synthesis [19, 20].
+
+We did not exclude studies based on methodological limitations, but rather will use the findings to assess the confidence in the findings.
+
+Data synthesis
+
+We used the convergent integrated approach. The quantitative data was then converted into “qualitized data.” This involved transformation into textual descriptions or narrative interpretation of the quantitative results in a way that answers the review questions [10].
+
+We grouped articles according to categories of demand generation, as defined above. We used a deductive thematic synthesis using the health system building blocks to synthesize the factors affecting implementation (barriers and facilitators).
+
+Appraisal of confidence in the review findings
+
+We used GRADE-CERQual to assess the confidence that can be placed in each review finding [21] based on four components: methodological limitations of included studies, coherence of the review findings, adequacy of the data contributing to a review finding, and relevance of the included studies to the review question. After assessing each of the four components, we made a judgement about the overall confidence in the evidence supporting each review finding. All findings start as high confidence and were then graded down if there are important concerns regarding any of the four components. We judged confidence as high, moderate, low, or very low. The final assessment was based on consensus among the review authors. We presented summaries of the findings and our assessments of confidence in these findings in the Summary of findings Table [21].
+
+Researchers’ reflexivity
+
+We maintained a reflexive stance throughout the stages of the review process, from study selection to data synthesis. The team discussed the Progress regularly and explored critically every step of the work. As a review team, we all have clinical backgrounds. In addition, three review authors have received advanced training in implementation science (AN, RK, JK) and are well versed in relevant theory. Based on our collective and individual experiences (as clinicians, academics and researchers), we anticipated the findings of our review to reveal a combination of organisational, professional and individual factors influencing the demand generation for family planning. We, as a team, remained mindful of our presuppositions and support each other to minimize the risk of these skewing the synthesis or the interpretation of the findings. We kept a reflexive journal throughout the review process in which to document and reflect on progress and decisions made [11].
+
+Results
+
+Study selection
+
+The flow of identification, screening, and including 46 reports is depicted in Fig. 1.Fig. 1 PRISMA Flowchart
+
+Characteristics of included studies
+
+The 46 included studies used Quantitative (41/46, 89.13%), Qualitative (1/46; 2.17%), and Mixed methods (4/46; 8.70%). The studies were reported from 23 countries from all regions and from Low (Ethiopia, Gambia, Madagascar, Malawi, Mali, Rwanda, Uganda, Yemen,Zambia), Lower middle (Cambodia, Cameroon, Egypt, Ghana, India, Iran, Kenya, Nepal, Nigeria, Pakistan, Senegal, Tanzania), Upper middle (Turkey) and High income (USA) countries, Table 1.
+
+Table 1 Number of included reports by country
+
+Country	Number of reports	Income	
+India	6	Lower middle	
+Pakistan	6	Lower middle	
+Kenya	3	Lower middle	
+Nigeria	3	Lower middle	
+USA	3	High	
+Ethiopia	2	Low	
+Malawi	2	Low	
+Ghana	2	Lower middle	
+Nepal	2	Lower middle	
+Tanzania	2	Lower middle	
+Gambia	1	Low	
+Madagascar	1	Low	
+Mali	1	Low	
+Rwanda	1	Low	
+Uganda	1	Low	
+Yemen	1	Low	
+Zambia	1	Low	
+Cambodia	1	Lower middle	
+Cameroon	1	Lower middle	
+Egypt	1	Lower middle	
+Iran	1	Lower middle	
+Senegal	1	Lower middle	
+Turkey	1	Upper Middle	
+
+Methodological quality
+
+For each included study, the methodological quality was described using the corresponding MMAT criteria. We judged 14 studies (30.43%) to be of low risk of bias, 10 studies (21.74%) to have a high risk of bias, and 22 studies (47.83%) to have an unclear risk of bias. We did not exclude studies based on methodological limitations, but rather used the findings to assess the confidence in the findings.
+
+Findings of the review
+
+We used a convergent integrated approach and a deductive thematic synthesis of the different approaches to scale up demand generation for family planning and the factors influencing implementation.
+
+Strategies of demand generation in family planning
+
+The review identified unique yet interrelated strategies of scaling-up demand generation for family planning, Table 2.
+
+Interpersonal communications included 16 reports: [22–37]. These included diverse approaches: home visits, one-on-one discussion, small group discussions, lectures, workshops. Community events included street plays and dramas, caravan road shows, community drama/puppet shows, sports competitions, beauty contests, bicycle races, public entertainment events, population weekends, and religious leaders’ speeches. This category included counselling and referral.
+
+Mass- and mid- media included Television, Radio, Wall paintings, Leaflets, Posters, Booklets, Brochures, Newspaper and magazines. New media included mobile messages and social media namely Facebook (advertisements or page) in 8 reports, [38–45].
+
+Demand-side financing strategies included small cash incentives and vouchers in 7 reports [46–52].
+
+Reports used a multifaceted approach, namely Interpersonal communications plus Mass media in 12 reports [53–64], Interpersonal communications plus Financing in 2 reports: [65, 66], and a bundle of Interpersonal communications plus Mass media plus Financing in one report [67].
+
+Table 2 Strategies of demand generation in family planning
+
+Theme	Sub-theme	Studies	
+Interpersonal communications	One-on-One discussion	[22, 54, 55, 42, 33]	
+	Community events (such as street plays and dramas, caravan road shows, community drama/puppet shows, sports competitions, beauty contests, bicycle races public entertainment events, population weekends)	[54–56, 59, 60]	
+	Small Group discussions	[55, 23, 42, 27, 28, 63, 35]	
+	Home visits	[66, 25, 27, 63, 37, 64]	
+	Religious leaders’ speeches	[28, 60, 32]	
+	Counselling and referral	[66, 26, 25, 36, 62, 34, 56, 24]	
+	Lectures, workshops	[29]	
+Mass media	Leaflets	[22, 66, 60, 30, 33, 62, 59]	
+	Posters	[66, 59, 60, 30, 62]	
+	Television	[56, 57, 59, 60, 44, 45, 63]	
+	Radio	[38, 39, 54–58, 60, 63]	
+	Wall paintings	[66, 59, 62]	
+	Booklets	[59, 62]	
+	Brochures	[58]	
+	Newspaper and magazines	[38, 39, 56]	
+	Facebook (advertisements, page)	[41, 43]	
+	Mobile messages	[57, 64]	
+Innovative financing interventions	Vouchers	[65, 66, 46, 47, 67, 49–51]	
+	Small cash incentives	[52]	
+
+Effect of demand generation strategies
+
+The effect of demand generation strategies were grouped by either reports of unique strategies, Table 3 or multifaceted strategies, Table 4.
+
+Interpersonal communications strategies contributed to 67.39% (31/46) of the reports either independently (Table 3) or as part of a bundle (Table 4) to generate demand for FP.
+
+Table 3 Summary of the reports of unique demand generations strategies
+
+Main Demand Generation strategy	Outcomes	Number of studies	Summarized review finding	GRADE-CERQual Assessment	
+Interpersonal communication	Adoption, Coverage, Sustainability	16	Interpersonal communications increase the use of modern contraceptive methods. The effect on sustainability is uncertain.	Moderate confidence	
+Mass media	Adoption, coverage	8	Mass media exposure increases knowledge and positive attitudes. Mass media may increase the intention to use modern contraceptive methods. The effect of new media is uncertain.	Moderate confidence	
+Demand side financing	Awareness, Adoption, Coverage	7	Demand-side financing approach (using vouchers or small cash incentives) probably increases awareness of contraceptives and the use of modern contraceptive methods among poor women.	Moderate confidence	
+
+Table 4 Summary of the reports of multifaceted demand generations strategies
+
+Main Demand Generation strategies	Outcomes	Number of studies	Summarized review finding	GRADE-CERQual Assessment	
+Interpersonal communications plus Mass media	Adoption, Coverage, Sustainability	12	Interpersonal communications plus Mass media increase adoption, use and sustainability of modern contraceptive methods among women and among men as well.	Moderate confidence	
+Interpersonal communications plus mass media plus financing	Awareness, Coverage, Sustainability	2	Interpersonal communications plus financing plus mass media increase the awareness and use of modern contraceptive methods and may promote sustainability	Low confidence	
+Interpersonal communications plus financing	Adoption, Coverage	1	Interpersonal communications plus financing may increase the intention to use and the actual use of contraceptive methods, particularly in people below poverty line.	Very Low confidence	
+
+Factors influencing demand generation for family planning
+
+The health system building blocks frame work was used for the synthesis of factors that influence demand generation for family planning.
+
+People
+
+Knowledge about family planning methods, especially regarding side effects and health concerns [32, 42, 56, 57].
+
+Woman’s preference and acceptability [42, 57].
+
+Engagement of partners in discussing family planning [25, 57].
+
+Interest to discuss family planning [39, 42].
+
+Motivation to use family planning [22].
+
+Reach of mass media [44, 54].
+
+Social acceptability to approach unmarried women to discuss contraception [25].
+
+Traditional and religious beliefs regarding the number of children [24].
+
+Financing
+
+Affordability of family planning services [25].
+
+Financial benefits associated with practicing family planning [35].
+
+Health workforce
+
+Providers’ age, gender, and religion [25, 35].
+
+Family planning nurses and community healthcare workers sharing sound knowledge [56].
+
+Number of Health workforce, especially female healthcare workers [24, 32].
+
+Leadership and governance
+
+Concurrent multiple demand generation programs within the same area in need [25].
+
+Consistency of implementing family planning programs [25].
+
+Degree of reliance on donor driven management and funding [25].
+
+Endorsement of family planning by the government [56].
+
+Integration of community-based health workers into healthcare system [25].
+
+Integration of non-governmental organizations trained field workers into the healthcare system [25].
+
+Medical products
+
+Availability of modern contraceptive methods [24, 32, 35, 54].
+
+Number of methods available to women [54].
+
+Service delivery
+
+Accessibility to family planning services [24, 35, 54].
+
+Ease of use of the family planning method [55].
+
+Discussion
+
+Summary of the evidence
+
+Demand-side unmet need (lack of demand for contraception), compared with supply-side unmet need, is responsible for the vast majority of total unmet need, ranging from 69 to 84% of unmet need [68]. This implies that a significant proportion of nonusers, irrespective of their age or level of education, consciously and knowingly decide against using modern family planning methods, even when they are not actively seeking to conceive [68–70]. Therefore, it was imperative to critically summarize best available evidence to understand what and how demand generation strategies can help for improving family planning services and reducing unmet need.
+
+In the current review, demand generation strategies in cross-cutting themes were identified within the included studies. Available evidence suggests that scaling up demand generation using interpersonal communication strategies can increase adoption and coverage of modern contraceptive methods, but the effect on sustainability is uncertain. Demand generation through mass media exposure increases knowledge and positive attitudes and may increase the intention to use modern contraceptive methods. The effect of new media is uncertain. Demand-side financing approach probably increases awareness and use of modern contraceptive methods among poor women. The results are in agreement with previous reviews that examined demand generation strategies and how these might improve adoption and coverage of family planning methods [71–73].
+
+Our results indicate that demand generation strategies may function independently or supplement each other. Each theme seems to improve certain aspect contributing to scaling up family planning. Evidence for sustainability is insufficient and this remains an important issue for countries striving to maintain a reduction in unmet needs and improvement of contraceptive prevalence rates. The need for integration with health system is critical for family planning to be institutionalized and therefore sustainable [74].
+
+The heterogeneity in the designs of studies assessing demand-side interventions and the lack of evidence on indicators used to measure the outcomes of such interventions make it difficult to draw overall conclusions about the strategies that can be scaled up. These issues have been observed, yet remain an resolved challenge [63].
+
+There is lack of reports on social media (one platform in two reports) and cellular phone technology (two reports) for demand generation in family planning. Social media allows users to connect in a virtual network or community, facilitating reach and usability of shared information. Types of social media include social networks (e.g., Facebook, Twitter), video sharing (e.g., YouTube), photo-sharing platforms (e.g., Instagram), or messaging apps (e.g., WhatsApp, Telegram). In each of these types, the over-arching characteristics include: connections and relationship-building, speedy delivery, and not limited by geography. This issue is extremely important in the currrent era since there is evidence that incorporating social media features into social behavior change activities has been shown to contribute positively to their success [75].
+
+In the current synthesis of barriers to the success of demand generation strategies included knowledge about family planning methods, especially regarding side effects and health concerns. The significance of providing precise information to individuals for making informed health decisions cannot be overstated [76]. The discussion of an individual’s lack of demand for contraceptive methods that health providers consider advantageous always necessitates a consideration of health literacy. The significance of health literacy is important, specifically in relation to the prevalence of “myths and rumors” as justifications for the non-utilization of contraceptives [77, 78]. Women’s concerns regarding the potential adverse effects of contraceptives on their bodies are valid. These valid concerns are conceptualized as a demand-side rationale for abstaining from contraceptive use. Particularly for those women whose inclination to avoid pregnancy is weak, the urge to avert contraceptive side effects may emerge as a more persuasive impetus, thereby culminating in non-utilization of contraceptives [79]. Although the concerns regarding the adverse effects of contraception is frequently associated with myths and misconceptions, an examination of women’s views revealed that individuals who attribute their non-use to health concerns are more likely to have previously used modern contraceptive method [80]. In the current era, it is critical to scrutinize the systematic exclusion of women’s voices from the debate concerning their bodies and families.
+
+Limitations
+
+Although we took every effort to minimize the potential for biases in the review process, sources of potential bias may exist. First, while our searches were comprehensive, there is a possibility that some relevant studies were missed for assessment by the review since the results of some programs may have not been made public.
+
+Second, a potential bias in reviews in this area is the adoption of clear criteria for what constitutes a standalone demand side strategy, which is never the case.
+
+Third, each theme of demand-generation contains a diversity of possible processes, content, and operational environments. Because these variables are often not controlled across studies, it is difficult to rigorously determine the situations in which specific strategies work best. Despite this, the strengths of different strategies in different circumstances can still be realized.
+
+Finaly, information regarding the processes of demand generation strategies in the included reports were not described in sufficiently informative details.
+
+Conclusions
+
+Demand generation strategies may function independently or supplement each other. Each category possibly improves certain aspect contributing to improving awareness, adoption, and use of modern contraceptive methods. Evidence for sustainability is insufficient. The myriad of techniques of the different demand generation strategies, the complexities of programs, and human interactions defy simplistic conclusions on how a specific strategy or a bundle of strategies may succeed in scaling up demand generation thus increasing use and sustaining family planning services.
+
+Acknowledgements
+
+Family Planning Research Collaborators: Alyaa Ashraf (Faculty of Medicine, Ain Shams University, Egypt), Emry Atwa (Faculty of Medicine, Ain Shams University, Egypt), Samhaa Bahnasy (Faculty of Medicine, Ain Shams University, Egypt), Marwa Elgendi (Faculty of Medicine, Ain Shams University, Egypt), Fatma Elghamry (Faculty of Medicine, Ain Shams University, Egypt), Amal Elshabrawy (Faculty of Medicine, Ain Shams University, Egypt), Salma Eltayeb (Faculty of Medicine, Ain Shams University, Egypt), Sara Galal (Faculty of Medicine, Ain Shams University, Egypt), Rita Kabra (World Health Organization, Switzerland), James Kiarie (World Health Organization, Switzerland), Mariam Kodsy (Faculty of Medicine, Ain Shams University, Egypt), Nada Makram (Faculty of Medicine, Ain Shams University, Egypt), Nourhan Mostafa (Faculty of Medicine, Ain Shams University, Egypt), Ashraf Nabhan (Faculty of Medicine, Ain Shams University, Egypt), Noha Sakna (Faculty of Medicine, Ain Shams University, Egypt), Mohamed Salama (Faculty of Medicine, Ain Shams University, Egypt), Marwa Snosi (Faculty of Medicine, Ain Shams University, Egypt), Nouran Wagih (Faculty of Medicine, Ain Shams University, Egypt), Ahmed Zenhom (Faculty of Medicine, Ain Shams University, Egypt).
+
+Authors’ contributions
+
+AN, RK, JK conceived the idea for this review and planned the systematic review methods. AN, FE, AA conducted the review. All members of the Family Planning Research Collaborators performed screening of studies and data extraction. AN, RK, JK collaborated in writing the first draft of this review. All members of the Family Planning Research Collaborators read and approved the final version.The authors alone are responsible for the views expressed in this article, and they do not necessarily represent the decisions, policy, or views of the World Health.
+
+Funding
+
+This work received funding from the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored program executed by the World Health Organization (WHO) (WHO-SRH/HRP-CFC grant number 2022/1240770-0).
+
+Availability of data and materials
+
+All data generated or analysed during this study are included in this published article and its supplementary information files.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Not applicable.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13029807
+PMID: 41894459
+DOI: 10.1371/journal.pone.0345711
+Article ID: PONE-D-25-06467
+Article version: 1
+Subjects: Research Article, Medicine and Health Sciences, Medical Conditions, Respiratory Disorders, Asthma, Medicine and Health Sciences, Pulmonology, Respiratory Disorders, Asthma, Medicine and Health Sciences, Epidemiology, Medical Risk Factors, Research and Analysis Methods, Research Assessment, Systematic Reviews, Social Sciences, Anthropology, Indigenous Populations, People and Places, Demography, Indigenous Populations, Medicine and Health Sciences, Medical Conditions, Infectious Diseases, Respiratory Infections, Medicine and Health Sciences, Medical Conditions, Respiratory Disorders, Respiratory Infections, Medicine and Health Sciences, Pulmonology, Respiratory Disorders, Respiratory Infections, Research and Analysis Methods, Database and Informatics Methods, Database Searching, Biology and Life Sciences, Psychology, Behavior, Habits, Smoking Habits, Social Sciences, Psychology, Behavior, Habits, Smoking Habits, Medicine and Health Sciences, Clinical Medicine, Clinical Immunology, Allergies, Allergic Diseases, Food Allergies, Biology and Life Sciences, Immunology, Clinical Immunology, Allergies, Allergic Diseases, Food Allergies, Medicine and Health Sciences, Immunology, Clinical Immunology, Allergies, Allergic Diseases, Food Allergies
+
+Factors associated with wheezing in Indigenous children and adolescents: A systematic review of the global literature
+
+Factors associated with wheezing in Indigenous children and adolescents
+
+https://orcid.org/0000-0002-6650-2551 de Castro Marcia Corrêa Conceptualization Formal analysis Investigation Methodology Project administration Writing – original draft Writing – review & editing 1 * ¤a
+Moore Daniella Campelo Batalha Cox Conceptualization Investigation Methodology Writing – original draft Writing – review & editing 2 3
+Camacho Karla Gonçalves Investigation 2 4
+dos Santos Gomes Saint Clair Junior Conceptualization Formal analysis Methodology Supervision Writing – original draft Writing – review & editing 5
+Salú Margarida dos Santos Writing – original draft Writing – review & editing 5 6
+de Azevedo Zina Maria Almeida Writing – review & editing 2
+Lisboa Sandra Writing – review & editing 2
+Cardoso Andrey Moreira Conceptualization Formal analysis Methodology Supervision Writing – original draft Writing – review & editing 7 * ¤b
+1 Education Department, Fernandes Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil
+2 Pediatrics Department, Fernandes Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil
+3 Internal Medicine Department, School of Medicine, Fluminense Federal University, Rio de Janeiro, Brazil
+4 Perinatal Center, Rio de Janeiro State University-UERJ, Rio de Janeiro, Brazil
+5 Clinical Research Department, Fernandes Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil
+6 Pediatrics Department, D’Or Institute for Research and Education-IDOR, Rio de Janeiro, Brazil
+7 Samuel Pessoa Department of Endemic Diseases, Sergio Arouca National School of Public Health-FIOCRUZ, Rio de Janeiro, Brazil
+Iwata Hiroyoshi Editor
+Hokkaido University: Hokkaido Daigaku, JAPAN
+Competing Interests: The authors have declared that no competing interests exist.
+
+¤a Current address: Education Department, Fernandes Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil
+
+¤b Current address: Samuel Pessoa Department of Endemic Diseases, Sergio Arouca National School of Public Health-FIOCRUZ, Rio de Janeiro, Brazil.
+
+* E-mail: marcia-castro-mc@fiocruz.br (MCC); andrey.cardoso@fiocruz.br (AMC)
+Electronic publication date: 2026 Mar 27
+Publication date: 2026
+Volume: 21
+Issue: 3
+Electronic Location ID: e0345711
+Received 2025 Feb 14; Accepted 2026 Mar 8
+Copyright: © 2026 de Castro et al
+Copyright year: 2026
+Copyright holder: de Castro et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 3
+Table count: 1
+Page count: 22
+Data Availability: All relevant data are within the paper and its Supporting information files.
+
+Data Availability
+
+All relevant data are within the paper and its Supporting information files.
+
+Ÿ==============================Ÿ
+Background
+
+Wheezing episodes are common in childhood and can occur due to different health conditions. Globally, Indigenous children are particularly affected, with a high burden of respiratory diseases related to socioeconomic inequalities, demographic characteristics, and exposure to environmental risks.
+
+Objective
+
+We summarize the knowledge available in the global literature on the determinants of wheezing in Indigenous children and adolescents and develop a theoretical model for analyzing them in Indigenous Brazilian children.
+
+Methods
+
+Systematic review conducted under the PRISMA 2020 criteria for studies, registered in PROSPERO (CRD42023395661). The Medline, Scopus, Web of Science, and LILACS databases were searched until September 2024. The inclusion criterion was analytical observational studies that showed risk factors for wheezing in children and adolescents (0–19 years). Studies that did not show specific results in the age group of interest, even if they included children and adolescents in their samples, book chapters, conference annals, or outcomes associated with chronic lung disease complications were excluded. Quality assessment was performed using the Newcastle-Ottawa Scale.
+
+Results
+
+Seventeen of the 263 analyzed studies were included in this systematic review, with a total of 139,783 participants. The most common design was cross-sectional (76.5%); most studies were conducted in North America (76.5%). Asthma was the most common type of wheezing episodes (88.2%). Male patients showed a more significant association with wheezing outcomes. Wheezing, when combined with asthma, was directly associated with age and inversely associated with age when accompanied by cold.
+
+Conclusion
+
+We identified three main factors for wheezing in Indigenous children and adolescents: Environmental (tobacco smoke, indoor pollution, and housing), socioeconomic (income, healthcare, and residence), and biological/clinical (sex, birth weight, infections, and allergies). We propose a model to analyze these factors in Indigenous Brazilian children. Differences in definitions, reliance on numerous cross-sectional studies, and focus on North America limit the generalizability of the results. Standardized methods and studies in new regions, particularly Brazil, are necessary for testing and refine this model.
+
+Introduction
+
+Wheezing is the sound of airflow passing through the airways when affected by any condition that leads to narrowing or obstruction hindering the respiratory cycle [1]. It is a clinical manifestation frequently associated with inflammatory processes of the airways, particularly the bronchioles, and is a common childhood disease in the first two years of life [1–8]. The respiratory syncytial virus (RSV) is the etiological agent most commonly associated with wheezing in bronchiolitis. However, other factors have been associated with this manifestation, such as maternal tobacco use during pregnancy [9–11], perinatal or neonatal complications that affect the development and maturation of the infant’s respiratory system, adverse intra-household environmental conditions during the postnatal period [7,12] and a variety of health conditions, such as the newborn’s transient tachypnea, asthma, gastroesophageal reflux disease, inborn errors of immunity, foreign body in the airway, vascular ring, bronchopulmonary dysplasia, cystic fibrosis, tracheoesophageal fistulas, primary ciliary dyskinesia, tumors, bronchiectasis, and congenital heart disease [5,13–15].
+
+Isolated or recurrent wheezing episodes, occurring three or more times during the first year of life, can negatively affect the health and quality of life of children and their caregivers [11,16,17]. Routine visits to emergency services, hospitalizations with respiratory support, and prolonged use of medications, combined with adverse socioeconomic conditions, affect child’s overall development.
+
+In the context of the first wheezing episodes and their repercussions in childhood, a multicenter longitudinal study on allergies conducted in children from birth to 13 years of age in Germany found heterogeneous manifestations of wheezing episodes in childhood, highlighting the importance of monitoring child for early diagnosis based on age at the first episode. The incidence of the first episode was the highest in the first year of life (18%) and decreased over the subsequent two years [18]. In South Brazil, 62.7% of low-income children had wheezing episodes in the first year of life, starting at five months of age, resulting in high frequencies of emergency room visits (58.2%) and hospitalization (16%) [17]. Thus, identifying children with a predisposition to wheezing from birth or the first episode and providing adequate monitoring can contribute to early identification of wheezing patterns and their determinants, guide clinical management and prevention, and ultimately improve child health.
+
+In developed countries such as the United States, Canada, New Zealand, and Australia, the burden of respiratory morbidity has been higher among Indigenous children when compared with non-Indigenous children [19–25]. A systematic review conducted in Australia found higher rates of RSV bronchiolitis, hospitalization, and ventilatory support in Indigenous infants aged 0–6 months than in non-Indigenous infants; these inequities were associated with inequalities in access to health services, housing conditions, and tobacco smoke exposure [12]. In Australia, a higher prevalence of severe wheezing episodes was found among Indigenous people aged 6–8 years (45.9%) than among non-Indigenous people of the same age group (31.5%) [26]. Despite the disparities in the occurrence of wheezing and its complications between Indigenous and non-Indigenous people and the diverse life contexts to which these population segments are subjected, a brief survey of systematic review and meta-analysis studies on “wheezing or respiratory sounds” and “associated factors or risk factors” in children aged 0–18 years conducted in October 2024 in the MEDLINE bibliographic database for the last 10 years identified 20 publications that included the term “wheezing” in the title or abstract, but none of them included Indigenous children.
+
+In Brazil, Indigenous people also have a high burden of respiratory diseases compared with the general population, particularly children [27–29]. Studies on the respiratory health of children in Guarani, one of the largest ethnic groups in the country, have shown the relevance of wheezing in Indigenous childhood morbidity profiles. For instance, based on hospitalization data of Guarani children under five who were prospectively followed for three years to conduct a case-control study on factors associated with the incidence of hospitalization due to acute respiratory infection of the lower respiratory tract, a prevalence of wheezing of 64.7% was identified in hospitalized children under one year of age, with symptoms concentrated in the autumn in the Southern Hemisphere (April–June) (64.2%). Wheezing was the main comorbidity associated with hospitalization [30]. There was a higher proportion of wheezing among Indigenous children hospitalized due to acute respiratory infections of a presumed viral etiology (40.8%) [31]. The relevance of acute respiratory diseases and wheezing among Indigenous Guarani children prompted the creation of the first cohort of Indigenous births in Brazil, the Guarani Birth Cohort, which aimed to describe the wheezing profile in the first year of life and identify factors associated with the incidence of wheezing in the cohort. This first systematic review of world literature on factors associated with wheezing in Indigenous children and adolescents aimed to summarize the current knowledge on the subject and support the development of a theoretical model for analyzing the determinants of wheezing in Indigenous Guarani children in Brazil.
+
+Materials and methods
+
+We followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, which are used for reporting systematic reviews and meta-analyses. We adhered to the guidelines of the Joanna Briggs Institute (JBI). These guidelines offer methods for conducting systematic reviews. The study was registered with PROSPERO (CRD42023395661), an international registry for systematic review protocols, on July 7, 2023. The initial search was conducted in March 2023 and updated in September 2024. We found no new studies beyond the initial searches in MEDLINE, Web of Science, Scopus, and LILACS (Latin American and Caribbean Health Sciences Literature). Readers can replicate our search strategy across relevant databases using the search terms and strings listed in S1 Supplement.
+
+Reporting Compliance: We used the PRISMA 2020 checklist. This tool outlines the steps for reporting systematic reviews. This ensured reproducibility and transparency during the review. We have defined the responsibilities of the reviewers. We provided the full search strings.
+
+The search terms were organized using a scientific library. We used Medical Subject Headings (MeSH), a standardized keyword system for indexing biomedical information; Health Sciences Descriptors (DeCS), a similar standardized term system used in Latin America and the Caribbean, as well as keywords from related studies, either alone or in combination, to meet the inclusion criteria and maximize sensitivity. We searched titles, abstracts, and keywords in English and Portuguese, adapting the terms to suit the specific requirements of each database. For instance: ((wheezing OR bronchiolitis OR bronchospasm OR asthma) AND ((“indigenous infants”) OR (“native children”) OR (“indigenous children”) OR (“indigenous population”) OR (“Indians central American”) OR (“North American Indians”) OR (“South American Indians”) OR (“health of indigenous peoples”) OR (“Australian Aborigines”) OR (“First Nations”))) AND (pediatric OR infants OR children) AND (risk factors OR associated factors OR etiology OR causes OR protective factors). Database-specific search terms are provided in S1 Supplement.
+
+Study eligibility and selection stages
+
+Bibliographic references were managed by the Covidence software (https://www.covidence.org). The selection resulting from the database search was conducted at different stages within the platform and under the criteria established for this research: 1) import of references in RIS or PubMed XML formats; 2) identification and exclusion of duplicate articles; 3) evaluation of titles and abstracts; 4) evaluation of full-text articles; 5) storage of articles in portable document format (PDF); 6) data extraction; and 7) quality analysis. During the title and abstract reading and full-text article analysis stages, the eligibility criteria were evaluated considering the previously defined inclusion and exclusion criteria. The inclusion criteria were studies involving Indigenous children or adolescents aged 0–19 that evaluated factors associated with wheezing or other outcomes of wheezing, such as bronchiolitis and asthma, and were restricted to analytical studies with a comparison group. There were no limitations regarding the language, data collection period, publication, or study design. We excluded studies without separate results for Indigenous children or adolescents, editorials, letters, book chapters, reviews or meta-analyses, conference abstracts, and studies in which wheezing was related to chronic lung disease complications, such as bronchiectasis, as well as unpublished articles. Two researchers (MCC and KGC) independently analyzed the texts selected at each stage, with a third researcher (DCBCM) serving as an arbitrator in cases of reaching no consensus.
+
+Data extraction
+
+Regarding data extraction, a form adapted from Covidence software was used, covering the following topics: general information, characteristics of the included studies, risk factors (sociodemographic, environmental, healthcare, biological, infectious, etc.), statistical analysis, and conclusions.
+
+Assessment of methodological quality and risk of bias
+
+Quality and risk of bias assessments were performed using the Newcastle-Ottawa Scale (NOS) [32] for case-control and cross-sectional studies. The NOS is a methodological quality rating tool for non-randomized studies that assigns points based on the selection, comparability, and assessment of outcome/exposure. According to the scale scores, the studies were categorized as having high quality and low risk of bias (≥8 points), moderate quality and moderate risk of bias (6–7 points), and low quality and high risk of bias (<6 points). The domains and scores are presented in the supplementary material (S2 Supplement).
+
+Summary of results
+
+We performed a descriptive synthesis of study characteristics and results included in this review. A descriptive synthesis summarizes findings narratively rather than statistically. The synthesis detailed the lead author, year of publication, country, associated factors, outcomes, and ratio-type effect measures (odds ratio [OR] or relative risk [RR]) along with their respective confidence intervals (CIs), as presented in S1 Table in S6 Supplement. ORs and RRs are statistical measures that indicate the strength of the association between risk factors and outcomes, whereas CIs show the reliability of these estimates.
+
+The results were grouped by continent and study quality to facilitate comparisons and reveal geographical patterns in the study outcomes. The subgroup themes focused on environmental factors, healthcare access, and socio-demographic variables, enabling a comprehensive comparative analysis of the unique challenges and determinants of wheezing across diverse global contexts.
+
+Results
+
+Evidence source
+
+In total, 263 publications were identified. After excluding 87 duplicate articles, 176 articles were screened after reviewing their titles and abstracts. During the screening, 104 studies that did not meet the established inclusion criteria were excluded. The remaining 72 articles were subjected to full-text review. At this stage, 55 articles were excluded, leaving 17 studies for further analysis (Fig 1). Fig 2 provides a comprehensive visual overview of the systematic review process, geographic distribution of studies, key findings, and main categories of factors identified. This figure synthesizes the results from 17 studies including 139,783 Indigenous children and adolescents across North America (76.5%), South America (11.8%), Central America (5.9%), and Oceania (5.9%), highlighting the predominance of cross-sectional designs (76.5%) and the need for research in underrepresented regions.
+
+10.1371/journal.pone.0345711.g001 Fig 1 PRISMA flowchart of studies included in the systematic review of global literature.
+
+10.1371/journal.pone.0345711.g002 Fig 2 Visual abstract summarizing the systematic review on factors associated with wheezing in Indigenous children and adolescents.
+
+The figure shows: (A) study objective and inclusion criteria; (B) systematic search methodology following the PRISMA 2020 guidelines across four databases (Medline, Scopus, Web of Science, LILACS); (C) quantitative results revealing 17 included studies from 263 initial records, encompassing 139,783 participants, with predominance of cross-sectional designs (76.5%); (D) geographic distribution demonstrating concentration in North America (76.5%; Canada 41.2%, USA 35.3%) with limited representation from South America (11.8%), Central America (5.9%), and Oceania (5.9%), and absence of studies from Asia and Africa; (E) key clinical findings including asthma as the most common condition (88.2%), male predominance, and age-related associations; (F) three main categories of identified associated factors: environmental (tobacco smoke, indoor pollution, and housing conditions), socioeconomic (income, healthcare access, and living conditions), and demographic (age, sex, and geographic location); and (G) key recommendations including standardization of methods, consideration of ethnic and cultural diversity, and addressing research gaps in underrepresented regions. Quality assessment performed using the Newcastle-Ottawa Scale. PROSPERO registration: CRD42023395661.
+
+Individual characteristics and results of evidence sources
+
+The years of publication of the studies extended from 1995 to 2022; however, with the exception of one study published in 1995, the others were published from 2004 onwards. The studies were conducted predominantly in North American countries (13/17, 76.5%), followed by South America (2/17, 11.8%) and Central America and Oceania, both with only one study (1/17, 5.9%) (Fig 3). All studies were published in English.
+
+10.1371/journal.pone.0345711.g003 Fig 3 Geographic distribution of studies included in the systematic review.
+
+World map showing 17 studies across 5 countries in the Americas and Oceania. Countries were color-coded according to the number of included studies: Canada (7, yellow), the United States (6, blue), Venezuela (2, orange), Guatemala (1, red), and Australia (1, green). Country boundaries were obtained from the OpenStreetMap contributors (www.openstreetmap.org) using the Open Database License (http://opendatacommons.org/licenses/odbl/1.0/).
+
+The most common study design was cross-sectional (13/17, 76.5%), followed by case-control (4/17, 23.5%). No other study design was identified. Four studies (23.5%) investigated more than one ethnic group, ranging between two (one study) and four (two studies) ethnic groups.
+
+Asthma was investigated as an outcome in 15 studies (88.2%), wheezing in one study (5.9%), and wheezing with cold in another study (5.9%). The variables investigated in the selected studies as possible factors associated with wheezing were classified into the following dimensions, with their respective frequencies of investigation: (1) Sociodemographic – age (10/17, 58.8%), sex (9/17, 52.9%), family income (5/17, 29.4%), area of residence (5/17, 29.4%), region of the country (4/17, 23.5%), education (4/17, 23.5%), ethnic group (3/17, 17.6%), access to health services (3/17, 17.6%), home ownership (2/17, 11.7%), caregiver marital status (1/17, 5.9%), and caregiver occupation (1/17, 5.9%); (2) Environmental – smoking in the home (8/17, 47.0%), crowding (3/17, 17.6%), dampness or mold in the home (3/17, 17.6%), wood-burning stove in the home (3/17, 17.6%), pets in the home (2/17, 11.7%), insect and rodent infestation (2/17, 11.7%), endotoxin in the home (1/17, 5.9%) and (3) Clinical-epidemiological – asthma (15/17, 88.2%), allergy (5/17, 29.4%), RSV, protozoan, and bacterial ear infections (5/17, 29.4%), body mass index (4/17, 23.5%), breastfeeding (4/17, 23.5%), low birth weight (3/17, 17.6%), family history of asthma (3/17, 17.6%), atopy (2/17, 11.7%), prematurity (2/17, 11.7%), physical activity or exercise (2/17, 11.7%), and smoking during pregnancy (1/17, 5.9%).
+
+The characteristics of the included studies and a summary of the data from this systematic review are presented in Table 1 (main text) and S1 Table (S6 Supplement).
+
+10.1371/journal.pone.0345711.t001 Table 1 Characteristics of studies included in the systematic literature review.
+
+First author/year	Location	Population	Study design	Outcome	Risk and bias classification	
+First author and publication year	Country	Ethnic group	Age (years)	Sample	N	
+Kovesi 2022 [33]	Canada	FN	≤ 3	Community (Sioux Lookout)	98	Sectional	Wheezing with a cold	Low risk	
+Rennie 2020 [34]	Canada	FN	6-17	Community (Saskatchewan rural zone)	351	Sectional	Atopic and Non-Atopic Asthma	Low risk	
+Karunanayake 2020 [35]	Canada	A, M, I	12-19	Census	25,170	Sectional	Asthma	Low risk	
+Kinghorn 2019 [36]	USA	AI	6-17	Indigenous health service	323	Case-control	Asthma	Low risk	
+Best 2017 [37]	USA	AI	6-17	Indigenous health service	323	Case-control	Asthma	Low risk	
+Best 2016 [38]	USA	AI	6-17	Indigenous health service	324	Case-control	Asthma	Low risk	
+Senthilselvan 2016 [39]	Canada	FN	0-11	First Nations Regional Health Survey	6,657	Sectional	Asthma	Low risk	
+Overeem 2014 [40]	Venezuela	W	0-2	Warao community	229	Sectional	Recurrent wheezing	Low risk	
+Kraai 2013 [41]	Venezuela	W	2-10	Warao community	630	Sectional	Asthma	Low risk	
+Chang 2012 [42]	Canada	NAI, M, I, MA	6-14	Aboriginal People Survey (APS)	48,921	Sectional	Asthma	Low risk	
+Ye 2012 [43]	Canada	NAI, M, I, MA	0-6	Census	14,170	Sectional	Asthma	Low risk	
+Shepherd 2012 [44]	Australia	AI	0-17	Western Australian Aboriginal Child Health Survey	5,289	Sectional	Asthma	Low risk	
+Crighton 2010 [45]	Canada	A	0-14	Aboriginal People Survey	35,495	Sectional	Asthma	Low risk	
+Surdu 2006 [46]	USA	MN	2-14	St. Regis Mohawk Health Service Records	50	Case-control	Asthma	Low risk	
+Lewis 2004 [47]	USA	AN, AI	10-18	Community (Yukon-Kuskokwim)	377	Sectional	Asthma	Low risk	
+Schei 2004 [48]	Guatemala	Mayan	4-6	Rural communities (Western Highlands of Guatemala)	1,058	Sectional	Asthma	Low risk	
+Clarck 1995 [49]	USA	NA	3-13	Community (Jemez Pueblo)	318	Sectional	Asthma	Low risk	
+FN = First Nation; A = Aboriginal; M = Meties; I = Inuit; AI = American Indian; W = Warao; NAI = North American Indian; MA = Multiple Ancestries; AI = Australian Indigenous; MN = Mohawk; NA = Alaska Native; Mayan = Mam-speaking Native American population; NA = Native American.
+
+Outcomes definitions varied substantially across studies. Most patients were diagnosed with physician-diagnosed asthma (n = 8, 47%), followed by the International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire criteria (n = 5, 29%), International Classification of Diseases, Ninth Revision (ICD-9) diagnostic codes (n = 3, 18%), and symptom-based definitions (n = 1, 6%).
+
+All selected articles used questionnaires to identify wheezing cases. Asthma, a major cause of wheezing in school-age children and adolescents, was defined as a parent-reported physician diagnosis of asthma” or parental perception of wheezing. Studies employing the ISAAC methodology have used standardized core questions about wheezing, physician diagnosis, other questionnaires, and physiological measures [50]. Obstructed airflow has long been recognized as the primary mechanism underlying wheezing, a key symptom of asthma and other diseases [51]. Wheezing can be considered an indicator of airway obstruction of interest, particularly for assessing young children and in situations where objective documentation of lung function is not readily available, such as among Indigenous populations [51]. However, this heterogeneity in outcome definitions limits the direct comparability of findings across studies.
+
+Summary of results
+
+Assessment of study quality and risk of bias.
+
+The seventeen studies (100%) showed high quality and low risk (≥8 points) of methodological bias. Analysis of the quality and risk of bias is available in a supplementary material (S2 Supplement).
+
+Factors investigated for association with wheezing
+
+(1) Sociodemographic factors
+
+Age was found to be a factor associated with wheezing in ten studies (58.8%); a statistically significant association with the outcome was identified in six (35.2%) of them [33,35,37,41,43,45]. There were variations in the age strata of the analyses and outcomes between the studies. Only one study [33] considered the outcome of wheezing associated with cold and identified an association between age < 3 years and wheezing in First Nations children living in an isolated community in Sioux Lookout, northwestern Canada. The remaining studies reported asthma as an outcome. The studies [35,43,45,49] identified a positive association between asthma and age in Indigenous children in North America, specifically in Canada. In contrast, another study [41] found an inverse association between age and asthma in the age ranges of 4–5 and 8–10 years. Therefore, wheezing combined with asthma was directly associated with age, whereas wheezing associated with cold was inversely associated with age.
+
+Child’s sex was investigated in nine studies (52.9%), all of which identified a statistically significant association with the outcome. In five studies (29.4%), female sex was considered the exposure category [35,41,39,40,52]; in four of these (23.5%), a lower probability of wheezing was identified in girls than in boys. The remaining four studies [43,45,49,42] considered male sex as the exposure category; all of them found a positive association, indicating that the eight studies were consistent in identifying male patients as more likely to exhibit the outcome compared with female individuals.
+
+Annual family income was assessed in five studies (29.4%); only two (11.8%) identified a positive association with the outcome [35,39]. However, income ranges in these studies were conflicting. One study [35] found a positive association between asthma and income below $44,999, while another study [39] found a positive association between asthma and high income of $60,000 or more.
+
+The area of residence was investigated in five studies (29.4%). A positive association was identified between living in an urban area and asthma [35,45] in two studies (11.8%), while an inverse association was found between living in a rural area and asthma (42, 43) in two other studies (11.8%). Furthermore, although one study [39] did not show a statistically significant association between living in a non-isolated area and outcomes, the results suggest a higher risk in residents in these areas compared with those in isolated areas.
+
+Four studies (23.5%) investigated the country’s regions; a positive association was identified, considering all regions investigated, in only one (5.9%), including the Atlantic/Quebec, Ontario, Manitoba/Saskatchewan, Alberta, and British Columbia [35]. Furthermore, an inverse association was identified between the Northern Territories and asthma in two studies (11.8%) [45,42].
+
+Caregivers’ educational level was investigated in four studies (23.5%); contrary to expectations, a positive association was identified between higher educational level and the outcome of asthma [35] in only one study (5.9%). Ethnic group was investigated in three studies (17.6%); in only two (11.8%) of them, an inverse association was identified between asthma and Inuit ethnicity compared with other ethnicities studied, such as Metis, Multiple Ancestors, and North American Indians [43,42].
+
+Access to health services was assessed in three studies (17.6%); only two (11.8%) of them identified an association with the outcome [43,42]. However, the study [42] showed a positive association between regular appointments and an increased prevalence of asthma, suggesting that children with more complex health conditions tend to seek medical care more regularly. In a previous study [43], the association between easy access to health services and asthma was inverse, suggesting that easy access to healthcare is associated with a lower probability of developing asthma. These studies complement our understanding about how various aspects of healthcare could influence the prevalence of asthma.
+
+Two studies (11.8%) assessed home ownership; however, only one (5.9%) identified a positive association between financed and rented housing and asthma outcome of asthma [44]. Only one study assessed caregiver occupation and marital status (5.9%) and found no statistically significant association with asthma outcome [44,36].
+
+(2) Environmental factors
+
+Eight studies (47.0%) investigated smoking; a positive association between cigarette smoke exposure and the outcome of asthma was identified in three studies (17.6%) of them [35,41,52]. However, one study (5.9%) showed a positive association between the absence of smokers in the household and outcome of asthma, possibly because of uncontrolled confounding factors [39].
+
+Three studies (23.5%) investigated household crowding; however, only two (11.8%) revealed a positive association between having 1–2 people under 18 and the outcome [35,39,53]. Furthermore, in the same study [39], a negative association was identified for people under 11 years of age in households with more than 4.
+
+Three studies (23.5%) investigated moisture and mold formation. However, only one study (5.9%) identified a positive association between the lack of exposure and outcome of atopic asthma [34]. This observation contradicted expectations and suggested that it might have been influenced by other confounding factors that were not controlled in this study.
+
+Three studies (17.6%) evaluated the use of wood-burning stoves at home; only one (5.9%) revealed a positive association between using wood-burning stoves as a cooking method and outcomes [41]. Two studies (11.8%) investigated the presence of a domestic animal; however, no statistically significant association was found between the presence of a domestic animal and outcome of asthma [36,46].
+
+Two studies (11.8%) investigated insect, cockroach, and ant infestations, however, none showed a statistically significant association with asthma [36,46]. Only one study (5.9%) analyzed home exposure to endotoxins and identified a positive association with wheezing [33].
+
+(3) Clinical-epidemiological
+
+Allergy was investigated in five studies (29.4%); all identified a positive association with the outcome of asthma [37,42,36,53,38]. However, the presence of allergies was heterogeneously evaluated in these studies. Allergen sensitization, as identified by specific immunoglobulin E (IgE), was evaluated in two studies that referred to the same population [37,38]. Two studies inquired about the presence of allergies without precisely defining the term [42,53]. One study investigated atopy and food sensitization [36]. The term “potential atopy carrier” was used for describing individuals with rhinitis symptoms without cold, accompanied by conjunctival symptoms [47]. One study assessed allergen sensitization by performing a spot-read test for six allergens. However, this factor was not used as a risk factor but rather to stratify patients into two groups: atopic and non-atopic asthma [34]. Only one study evaluated genetic factors associated with asthma development and highlighted the importance of genetic variants in chromosomes 5q22.1 and 17q21 in Native American children [37]. Humoral factors, such as total serum IgE, peripheral eosinophils, and leukocytes were evaluated in only one study [38].
+
+Five (29.4%) studies investigated previous infections. Three studies revealed a positive association between RSV, protozoan, and bacterial ear infections and asthma outcomes [43,40,36]. However, one study [53] showed no statistically significant association between chronic ear infection and asthma outcomes. Another study [34] showed that the prevalence of a history of respiratory infection was higher in the non-atopic asthma group.
+
+Five studies (29.4%) investigated body mass index; four (23.5%) identified a positive association between being overweight or obese and asthma outcome [35,37,42,34]. However, one study (5.9%) did not find a statistically significant association with the outcome.
+
+Four studies (23.5%) investigated breastfeeding; two (11.8%) showed an inverse association with breastfeeding [43,46]. Two other studies revealed no statistically significant associations with outcomes [49,42]. Three studies (17.6%) investigated low birth weight, all of which showed a positive association with outcomes [43,42,53].
+
+Three studies (17.6%) investigated family history of asthma; two (11.8%) reported a positive association with asthma outcome [33.45]. Two studies (11.8%) investigated atopy; both revealed a positive association with asthma outcome [52,36].
+
+Premature birth was investigated in two studies (11.8%); however, neither showed a statistically significant association with asthma outcome [33,46]. Physical activity and exercise were investigated in two studies (11.8%). One study (5.9%) of these two identified a positive association with asthma outcome [48], whereas another [53] showed an inverse association when exercising daily. Smoking during pregnancy was investigated in one study (5.9%); however, no statistically significant association with asthma outcome was identified [46].
+
+Discussion
+
+This systematic review is the first to identify factors associated with wheezing in Indigenous children and adolescents by analyzing 17 observational studies with 139,783 participants from diverse ethnic groups across four continents.
+
+Clinical manifestations and diagnosis
+
+Among the main findings in this study, asthma was identified as the most common condition for wheezing episodes (88.2%). A study comparing among Indigenous and non-Indigenous children in the prevalence of asthma included children aged 0–17 years, mostly <10 years, in five remote Indigenous communities in Australia and concluded that the prevalence of asthma and wheezing episodes was as high as in non-Indigenous groups [19]. Asthma remains one of the most common chronic respiratory diseases in children and is characterized by wheezing, shortness of breath, and coughing, which can be triggered by various stimuli. Wheezing is a key feature for diagnosing asthma. If it is not present, it is unlikely that a diagnosis of asthma will be made in a child [54]. However, several other causes of wheezing in childhood, including cystic fibrosis, gastroesophageal reflux disease, bronchiolitis, and parasitosis appear to be underdiagnosed [55].
+
+Male sex was associated with a higher incidence of wheezing as evidenced in eight articles, whereas one study showed a risk associated with female sex. An asthma prevalence study that included 1,290 urban Aboriginal children aged 1–17 years and found a higher prevalence of asthma among boys [56]. However, in the scientific literature, a disparity between the sexes regarding asthma is apparent, with a higher prevalence in boys up to 13 years of age (65%). This pattern changes in adulthood, when asthma becomes more prevalent in female individuals. This male predominance aligns with the global trends in pediatric asthma [57]. The only study that identified a risk associated with female sex studied a population aged 10–18 years, of which 33% were over 14 years of age, which might have influenced this result [47].
+
+Socioeconomic factors
+
+Regarding annual income, one study found an association between high income and the risk of wheezing [39], whereas two others found an association with low income [58,59]. The association between wheezing and higher income was attributed to the fact that these parents also had higher levels of education and better access to healthcare and diagnostic services [39]. Conversely, a study that found a higher occurrence of wheezing among those with lower incomes reported greater vulnerability to viral infections, which were triggers of asthma in this population, as well as a higher rate of hospitalization due to asthma [59].
+
+Living in rural areas was considered a protective factor. The lower incidence of wheezing among rural residents was attributed to the hygiene hypothesis, originally proposed by Strachan in 1989 [60], which posits that reduced microbial exposure in modern environments increases susceptibility to allergic diseases. Subsequent studies in general populations have consistently documented that agricultural environments, characterized by high exposure to microbial agents such as endotoxins and diverse bacterial communities, confer a protective effect against asthma and atopy [61,62,63]. Similar protective effects of rural environments have been observed in indigenous populations [58]. Some authors have reported a higher prevalence of asthma symptoms in children living in urban areas, which might be attributed to the protection of the agricultural environment [61,64,65]. Greater exposure to pollutants in urban environments might also contribute to this protective rural effect, which usually produces fewer pollutants than urban environments [45]. However, one factor that might contribute to a non-beneficial protective effect is reduced access to health services in rural areas, and consequently, lower identification of wheezing cases in these areas [66].
+
+Environmental factors
+
+Investigating specific rural exposures such as microbial diversity might provide insights into reducing asthma rates in urban environments. Identifying and replicating these protective factors could inform policies and support targeted public health interventions, ultimately enhancing their effectiveness.
+
+Tobacco exposure revealed contradictory results, with studies associating a greater magnitude of wheezing among individuals who had no contact with passive smokers. As the harmful effects of tobacco exposure have already been proven in scientific literature to exacerbate asthma and other respiratory diseases [67], the higher likelihood of wheezing in an environment without tobacco exposure could be interpreted as a consequence and not a cause, reflecting the behavior of adults who stop smoking because they have an asthmatic child at home. Regarding passive smoking exposure, we observed that two studies reported it differently, which hindered our comparison, highlighting, not only in this variable but also in several others, the importance of standardizing some exposure indicators besides wheezing-related outcomes to identify modifiable risk factors and change the pattern of occurrence of wheezing, asthma, and their repercussions on children’s health.
+
+Two studies have identified exposure to wood-burning stoves as a risk factor for wheezing. An integrative review of the literature to determine the environmental factors contributing to the increased prevalence and severity of asthma among Navajo children living on reservations identified indoor air pollution, with particular emphasis on exposure to wood-burning stoves and coal combustion, as factors that increase the risk of respiratory disease [68].
+
+Biomass fuels used for heating homes and cooking, as well as cigarette and wood-burning stove smoke, contain numerous human carcinogens, including polycyclic aromatic hydrocarbons, which have higher levels of carbonaceous nuclei than cigarette smoke [69]. To provide clearer intervention targets, specifying particulate matter (PM2.5) levels or polycyclic aromatic hydrocarbon concentrations in wood-burning stoves could offer readers an actionable framework for environmental regulations. These exposures might be associated with several acute and chronic respiratory diseases, such as asthma, acute respiratory tract infections in adults and children, chronic obstructive pulmonary disease, lung cancer, and tuberculosis [70].
+
+Studies have suggested that caregivers believe that protecting children from exposure to secondhand tobacco smoke can be an important motivation for establishing smoke-free homes [71]. Thus, pollution within the home environment should be assessed, along with the beliefs of the Indigenous population, which can help identify barriers to achieving a smoke-free environment.
+
+Among other housing conditions, such as the presence of mold, humidity, and endotoxins, only exposure to endotoxins was significantly associated with the outcome. The authors suggested that the increased risk of wheezing associated with cold, when combined with exposure to endotoxin, a component of the cell wall of Gram-negative bacteria, might indicate that asthma has been underdiagnosed [72]. The use of a self-report questionnaire in a study assessing the presence of mold and humidity might have underestimated the actual presence of these factors, which could have affected the final results. This highlights the importance of a more objective assessment [73] of these potential exposure risks. A systematic review of the European Academy of Allergy and Clinical Immunology guidelines on environmental science for allergic diseases and asthma identified that exposure to moisture or mold increases the risk of wheezing [74]. Standardizing the collection of these data using the Environmental Relative Moldiness Index might provide more accurate information on this risk factor [75].
+
+Access to health services is important for interpreting data on the risk factors for wheezing. However, only one study has evaluated this issue; univariate analysis showed that the prevalence of asthma among children with difficulty in accessing health services was twice as high as that among those without the same barriers to access [76].
+
+Early-life and nutritional factors
+
+Low birth weight was assessed in three studies and found to be positively associated with asthma, whereas breastfeeding during infancy was identified as a protective factor. Together, these data indicate the importance of perinatal care in preventing asthma development in the first months of life. An association between being overweight and/or obese and asthma was found in four studies and has already been indicated in the literature as having a bidirectional association [77]. Obesity might result in a decreased response to inhaled corticosteroids owing to changes in airway smooth muscle and restricted chest wall movement, in addition to chronic low-grade systemic inflammation, leading to more frequent asthma symptoms. Conversely, poorly controlled asthma might result in limited physical activity and lead to a sedentary lifestyle, which contributes to obesity [77].
+
+Allergic and immunological factors
+
+Regarding allergies, lacking standardization in defining and measuring exposure has hindered the comparison of studies. Allergen sensitization to aeroallergens, food allergens, and rhinitis in the absence of cold are among the criteria that contribute to the score for predicting modified asthma development in preschool children [78]. Scores for predicting asthma in certain age groups that might be useful for this assessment are already available [79]. Identifying other allergic diseases associated with wheezing, such as rhinitis, atopic dermatitis, allergic conjunctivitis, and food allergies, might increase the probability of allergic asthma due to atopic diathesis [80]. To improve comparability among future studies, researchers should consider using standardized tools and criteria such as validated questionnaires and biomarker panels for allergy assessment. Such tools could help ensure consistent data collection and a more robust analysis of allergic risk factors.
+
+Genetic factors
+
+Regarding the genetic risks for developing asthma, only one study contributed to increasing the knowledge about these factors in the indigenous population, which has historically been excluded from genetic studies of asthma [37].
+
+Infectious factors
+
+The predisposition to wheezing associated with respiratory infections should be understood in a broader context. Therefore, an important concept is that of a single airway, in which the upper and lower airway management must be understood as a single physiological unit, meaning that an inflammatory condition affecting one system tends to affect another similarly [81]. Because of the connection of the middle ear to the airway via the Eustachian tube, middle otitis might increase the risk of asthma, particularly in children, due to the immaturity of the auditory or Eustachian tube [82].
+
+Another important factor to consider is that, although asthma is a significant cause of wheezing in childhood, many of our children experience wheezing as infants, typically during viral infections. Cohort studies conducted in the US [83,84], Australia [85,86], and Europe [87] have shown that although wheezing is common during childhood, specifically in association with respiratory infections, it usually resolves spontaneously by the age of 3 years. Determining whether wheezing during a viral infection is an early manifestation of asthma is challenging [88]. Understanding whether wheezing caused by viral infections, which are most common in childhood, is underdiagnosed and interpreted as asthma is crucial. Severe RSV infection early in life is associated with wheezing onset in childhood [89]. Studies by Sigurs et al. (2010) showed a 7.2-fold increased risk of asthma at the age of 18 years following severe RSV bronchiolitis [90]. Epidemiological studies have suggested that the risk of asthma following bronchiolitis is related to the episode’s severity, with children requiring hospitalization showing a 2.8-fold increased risk of asthma at ages 4.5–5.5 [91]. Bacharier et al. (2012) also demonstrated that severe RSV bronchiolitis in the first year of life is associated with a diagnosis of asthma around the age of 7 years in 48% of children, corresponding to nearly half of all children [92]. Vaccination of pregnant women at the end of pregnancy with RSV reduces hospitalizations in children [93]; moreover, its protective effect against asthma might be promising. However, the results of these studies were unclear.
+
+Parasitic infections
+
+Overeen et al. (2014) [40] found a protective effect associated with parasitic infection, which has already been described in the literature and is attributed to the immunomodulatory effect of infections by parasites such as A. lumbricoides, Schistosoma mansoni, Strongyloides stercoralis, and T. trichiura, which have been associated with reduced allergic airway inflammation [94]. Despite this, Loeffler’s syndrome, a transient eosinophilic pneumonia caused by helminths, should be considered in the differential diagnosis of wheezing in childhood [95,96].
+
+Geographical disparities and research gaps
+
+However, 76.4% of these studies were conducted in North America, a region comprising a small proportion of the global Indigenous population. This geographic concentration highlights the systemic research funding and priority patterns that limit the representation of broader ethnic and geographic diversity. Addressing this imbalance requires equitable research funding for underrepresented regions as well as collaboration with local researchers and Indigenous communities. Translating social drivers, such as ‘income inequality’ and ‘housing quality,’ into quantifiable metrics that allow these factors to be consistently embedded across studies is essential. This operational definition will guide future researchers in effectively integrating equity variables.
+
+To address geographic research gaps, a concrete next step could be to initiate region-specific funding programs that encourage research participation from underrepresented areas such as Central and South America and Oceania. These programs can be designed to support local institutions and provide resources for the comprehensive study of Indigenous populations. In addition, organizing joint research initiatives and exchange programs between universities in well-researched regions and institutions in underrepresented areas can foster collaboration and mutual knowledge transfer.
+
+Capacity building and knowledge transfer initiatives are essential for achieving more comprehensive and representative research. To facilitate this, specific strategies such as training workshops and research partnerships with local Indigenous communities and institutions are crucial. Establishing platforms for researcher exchange and providing funding for collaborative projects can also promote knowledge transfer and build local research capacity, paving the way for more inclusive and diverse studies worldwide. Additionally, implementing dedicated funding mechanisms such as grants specifically for indigenous health research can effectively prioritize this area. Developing partnership models that involve government agencies, universities, and community organizations can also contribute to a more coordinated approach to address these challenges. Ultimately, establishing an international consortium dedicated to indigenous respiratory health research might unify global efforts and ensure sustained attention and effective allocation of resources.
+
+According to statistical data from the Brazilian Institute of Geography and Statistics for the 2022 Census, the Brazilian Indigenous population is estimated to be approximately 1.7 million (representing 305 ethnic groups), which accounts for 0.83% of the national population and is mainly concentrated in the northern and northeastern regions of the country. However, no Brazilian study has been identified that evaluates factors associated with wheezing in isolation, that is, without considering the context of other respiratory diseases and their severity, such as hospitalization and death, as outcomes [27,30,31,97,98]. To address these regional research gaps, it is crucial to implement targeted strategies, such as increased funding specifically aimed at respiratory health research, among Indigenous Brazilian communities. Establishing partnerships with local universities, health institutes, and indigenous organizations is essential for initiating and sustaining these research efforts. One practical approach is to organize co-design workshops with Indigenous Brazilian leaders to collaboratively develop future studies. These workshops could incorporate participatory methods, such as focus group discussions and scenario planning, to ensure that the research questions and methodologies align with the needs and insights of Indigenous communities. Initiatives such as research grants and scholarships for studies focused on respiratory health issues affecting Indigenous populations could further stimulate interest and expertise in this under-researched field. Encouraging collaboration and data sharing among regional and international researchers may also enhance the quality and scope of research findings, ultimately fostering a more comprehensive understanding of the determinants of wheezing in these communities.
+
+Study limitations
+
+A significant limitation of this systematic review was the geographical distribution of the included studies, with 76.5% conducted in North America. This geographical concentration might compromise the generalizability of the results to other regions, particularly in low- and middle-income countries, where socioeconomic conditions, health systems, and population characteristics might present substantial disparities.
+
+The predominance of North American studies could be attributed to various factors, including the greater availability of research resources, differences in scientific publication practices, and selection biases related to the databases consulted. The unequal distribution of this information compromises our ability to understand how these findings apply to contexts with different health infrastructures, cultural variations, distinct epidemiological profiles, and limited economic resources.
+
+Furthermore, the studied populations may not be representative of global ethnic and racial diversity, which might have affected the external validity of the results. Disparities in treatment protocols, clinical guidelines, and health financing systems across countries might also have influenced the observed outcomes, thereby limiting the international applicability of the findings.
+
+This geographical limitation constitutes a significant gap in current knowledge, which underscores the urgent need for additional studies conducted in underrepresented regions. In this study, we aimed to validate and expand our understanding about the factors associated with wheezing in Indigenous children and adolescents across various global contexts. In future systematic reviews, more comprehensive search strategies should be prioritized, and the inclusion of regional databases should be emphasized to reduce geographical bias.
+
+Beyond geographical limitations, this systematic review encountered several methodological challenges, primarily related to study heterogeneity, which precluded conducting a meta-analysis.
+
+First, there was substantial variability in the definitions of the outcomes across studies. The definitions ranged from standardized ISAAC questionnaires (23.5%) and physician diagnoses (41.2%) to administrative ICD-9 codes (17.6%) and symptom-based self-reports (11.8%). This definitional heterogeneity might have influenced case identification and the strength of the associations with risk factors.
+
+Second, lacking standardization in defining and collecting data on potential risk factors, whether wheezing alone or in conjunction with asthma and bronchiolitis, represents a significant challenge for evidence synthesis. This variability limits the ability to identify modifiable factors that can be targeted through interventions to reduce the burden of wheezing and asthma in Indigenous children and adolescents.
+
+Standardization of outcome definitions and risk factor measurements in future studies would substantially enhance comparability and enable robust meta-analyses in Indigenous populations.
+
+Another limitation is the design of the identified studies, which was predominantly restricted to cross-sectional and case-control studies. Such studies prevent the calculation of direct risk averages and are more susceptible to biases, such as reverse causality and recall bias, which have the potential to distort the investigated relationships. This result is noteworthy, considering the satisfactory quality assessment of the articles included in the review. To address these limitations, prioritizing the implementation of prospective cohort studies is imperative, particularly in underrepresented regions, to establish a clearer temporal sequence and causality. Prospective birth cohort studies can monitor participants from birth and collect exhaustive data on salient variables such as smoke exposure, wheezing incidence, and other potential risk factors over time. Thus, a two-stage case-control study would be beneficial. In this study, cases and controls were matched based on specific criteria, and retrospective data on previous smoke exposure were collected. Furthermore, the incorporation of mixed-methods or participatory research designs has the potential for addressing existing limitations by combining quantitative data with qualitative insights, thereby providing a more comprehensive understanding of wheezing across diverse contexts.
+
+To address the limitations of this review, we recommend several research priorities.
+
+First, prospective cohort studies in underrepresented regions, particularly Central and South America, Oceania, Asia, and Africa, are urgently needed for establishing temporality and enabling causal inferences regarding environmental, socioeconomic, and genetic factors associated with wheezing. Priority research questions for such studies include: (1) whether early life tobacco smoke and indoor air pollution exposure increase the risk of developing wheezing by the age of five, as measured by pulmonary function tests; (2) how variations in socioeconomic status (family income, healthcare access, housing quality) predict differences in wheezing prevalence and severity across diverse indigenous populations; and (3) identification of specific genetic markers associated with elevated wheezing risk in indigenous populations and their potential utility for targeted prevention strategies.
+
+Second, methodological standardization is essential. Future studies should adopt standardized outcome definitions (such as the ISAAC questionnaire criteria) and consistently measure exposure variables (including objective assessments of indoor air quality, mold exposure using the Environmental Relative Moldiness Index, and validated socioeconomic indicators). This standardization enables robust meta-analyses and more definitive conclusions about modifiable risk factors. Incorporating community consent processes into the study design is crucial to ensure that participatory ethics are an integral part of the research methodologies, thereby safeguarding cultural safety throughout the research process.
+
+Third, community-based participatory research approaches are appropriate for indigenous populations. Longitudinal projects that involve Indigenous communities in the conception, design, and implementation of studies ensure cultural appropriateness and ethical conduct while addressing local priorities. Mixed-method studies, which combine quantitative epidemiological data with qualitative interviews, can capture cultural and contextual factors that influence respiratory health, which purely might be overlooked by quantitative.
+
+Finally, specific attention should be directed toward underdiagnosed conditions, such as parasitic infections, severe RSV bronchiolitis, and non-asthmatic causes of wheezing in indigenous children. Understanding the full spectrum of wheezing etiologies in these populations is essential for developing comprehensive and culturally appropriate prevention and management strategies.
+
+Conclusion
+
+In this systematic review we summarize evidence from 17 studies on factors associated with wheezing in Indigenous children and adolescents globally, identifying three main domains of determinants: environmental factors (tobacco smoke exposure, indoor air pollution from wood-burning stoves, and housing conditions, including mold and humidity), socioeconomic factors (income level, healthcare access, and rural-urban residence), and biological/clinical factors (male sex, age, low birth weight, obesity, breastfeeding, allergic sensitization, respiratory infections, and parasitic infections).
+
+Based on these findings, we proposed a theoretical model to analyze the determinants of wheezing in Indigenous Brazilian children, accounting for the complex interplay among these three domains within the specific context of Brazil’s 305 indigenous ethnic groups.
+
+Wheezing in Indigenous children is not solely a clinical issue, but a reflection of structural and environmental determinants. Our systematic review identified three key domains: environmental exposure (tobacco smoke, biomass fuel, and mold), socioeconomic inequities (low income and rural healthcare barriers), and biological susceptibility (early life respiratory infections and male sex). Although the data align with global asthma patterns, the specific burden of indoor air pollution and housing quality in Indigenous communities highlights urgent targets for public health intervention.
+
+However, the generalizability of these findings is constrained by a significant research bias toward North American populations and the absence of data from the Global South, particularly Brazil, where the interplay between infectious and allergic wheezing remains poorly understood. To address this issue, future research must move beyond cross-sectional designs to prospective cohorts with standardized definitions of wheezing and environmental exposure.
+
+Validating this model requires prospective cohort studies in Brazil that use standardized definitions and community-based participatory approaches to address local cultural and socioeconomic realities. The proposed theoretical model, integrating the environmental, socioeconomic, and biological domains, should guide future studies to identify unique respiratory health determinants for Indigenous children in underrepresented regions.
+
+Supporting information
+
+S1 Supplement Database search.
+
+(DOC)
+
+S2 Supplement Quality and risk of bias analysis.
+
+(DOC)
+
+S3 Supplement PRISMA 2020 checklist.
+
+(PDF)
+
+S4 Supplement PRISMA 2020 for abstracts checklist.
+
+(PDF)
+
+S5 Supplement Prospero Record.
+
+(PDF)
+
+S6 Supplement S1 Table: Summary of results.
+
+(DOCX)
+
+Stricto Sensu Postgraduate Program in Applied Research in Child Health, Department of Education, Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil.
+
+To the Clinical Research Department of the Fernandes Figueira National Institute of Women, Children, and Adolescent Health-FIOCRUZ, Rio de Janeiro, Brazil.
+
+To the Samuel Pessoa Department of Endemic Diseases, Sergio Arouca National School of Public Health-FIOCRUZ, Rio de Janeiro, Brazil.
+
+
+References
+
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+70 Lee KK , Bing R , Kiang J , Bashir S , Spath N , Stelzle D , et al. Adverse health effects associated with household air pollution: a systematic review, meta-analysis, and burden estimation study. Lancet Glob Health. 2020;8(11):e1427–34. doi: 10.1016/S2214-109X(20)30343-0 33069303 PMC7564377
+71 Stevenson L , Campbell S , Bohanna I , Gould GS , Robertson J , Clough AR . Establishing Smoke-Free Homes in the Indigenous Populations of Australia, New Zealand, Canada and the United States: A Systematic Literature Review. Int J Environ Res Public Health. 2017;14(11):1382. doi: 10.3390/ijerph14111382 29135950 PMC5708021
+72 Kovesi T , Mallach G , Schreiber Y , McKay M , Lawlor G , Barrowman N , et al. Housing conditions and respiratory morbidity in Indigenous children in remote communities in Northwestern Ontario, Canada. CMAJ. 2022;194(3):E80–8. doi: 10.1503/cmaj.202465 35074834 PMC8900755
+73 Rennie DC , Karunanayake CP , Lawson JA , Kirychuk S , McMullin K , Abonyi S , et al. Domestic Risk Factors for Atopic and non-Atopic Asthma in First Nations Children Living in Saskatchewan, Canada. Children (Basel). 2020;7(5):38. doi: 10.3390/children7050038 32349273 PMC7278566
+74 Agache I , Canelo-Aybar C , Annesi-Maesano I , Cecchi L , Biagioni B , Chung F , et al. The impact of indoor pollution on asthma-related outcomes: a systematic review for the EAACI guidelines on environmental science for allergic diseases and asthma. Allergy. 2024;79(7):1761–88.38366695 10.1111/all.16051
+75 Vesper SJ . The development and application of the Environmental Relative Moldiness Index (ERMI). Crit Rev Microbiol. 2025;51(2):285–95. doi: 10.1080/1040841X.2024.2344112 38651788
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+78 Chang TS , Lemanske RF Jr , Guilbert TW , Gern JE , Coen MH , Evans MD , et al. Evaluation of the modified asthma predictive index in high-risk preschool children. J Allergy Clin Immunol Pract. 2013;1(2):152–6. doi: 10.1016/j.jaip.2012.10.008 24187656 PMC3811153
+79 Castro-Rodriguez JA , Cifuentes L , Martinez FD . Predicting Asthma Using Clinical Indexes. Front Pediatr. 2019;7:320. doi: 10.3389/fped.2019.00320 31463300 PMC6707805
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diff --git a/corpus/healthcare/text/6558e4411b588816.txt b/corpus/healthcare/text/6558e4411b588816.txt
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@@ -0,0 +1,380 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Parasit Vectors
+Journal ID: Parasit Vectors
+NLM Journal ID: 101462774
+
+Parasites & Vectors
+
+EISSN: 1756-3305
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12973600
+PMID: 41792828
+DOI: 10.1186/s13071-026-07264-w
+Article ID: 7264
+Article version: 1
+Subjects: Research
+
+Post elimination of lymphatic filariasis: a situation analysis of brugian filariasis and vector potentialities within the filarial transmission belt in Sri Lanka
+
+Nimalrathna Sachini U. 1 2
+Harischandra Hiruni 3
+Chandrasena Nilmini 4
+Kimber Michael J. 5
+de Silva Nilanthi 4
+Mallawarachchi Chandana H. 6
+Nimalrathna Thilina S. 6
+de Silva B. G. D. Nissanka K. nissanka@sci.sjp.ac.lk
+1
+1 https://ror.org/02rm76t37 grid.267198.3 0000 0001 1091 4496 Center for Biotechnology, Department of Zoology, Faculty of Applied Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
+2 https://ror.org/04rswrd78 grid.34421.30 0000 0004 1936 7312 Department of Veterinary Pathology, Iowa State University, Ames, IA USA
+3 https://ror.org/02rm76t37 grid.267198.3 0000 0001 1091 4496 Genetics and Molecular Biology Unit, Faculty of Applied Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka
+4 https://ror.org/02r91my29 grid.45202.31 0000 0000 8631 5388 Department of Parasitology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
+5 https://ror.org/04rswrd78 grid.34421.30 0000 0004 1936 7312 Department of Biomedical Sciences, Iowa State University, Ames, IA USA
+6 https://ror.org/02zhqgq86 grid.194645.b 0000 0001 2174 2757 School of Biological Sciences, University of Hong Kong SAR, Hong Kong, China
+Electronic publication date: 2026 Mar 6
+Publication date: 2026
+Volume: 19
+Electronic Location ID: 108
+Received 2025 Oct 21; Accepted 2026 Jan 13
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Brugian filariasis vectors, Mosquito surveillance, Brugia malayi, Post-elimination, Sri Lanka
+
+Funding: https://doi.org/10.13039/501100008816 University of Sri Jayewardenepura ASP/01/RE/SCI/2022/31
+
+Funding: National Research Council, Sri Lanka 19-028
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Background
+
+Sri Lanka is experiencing a re-emergence of brugian filariasis 4 decades after its elimination in 1969. A comprehensive understanding of the mosquito species that can facilitate the development of the brugian parasite is essential for implementing targeted surveillance and control measures. This study evaluated the vector potentiality of field-caught mosquitoes for brugian parasites across endemic districts within the filarial transmission belt in Sri Lanka.
+
+Methods
+
+Mosquito surveillance was conducted at six sites across five districts with the highest reported brugian cases during 2021–2022. Mosquitoes were collected at the site of the most recently reported human brugian case in each district using dog-baited, window and gravid traps to maximize species diversity and abundance in the sample. Mosquitoes were identified morphologically, and randomly selected mosquitoes were molecularly confirmed via a PCR targeting the COΙ region. Vector potentiality was evaluated by observing nematode parasites upon dissection, molecular confirmation via PCR and sequencing the Brugia sp.-specific HhaΙ region. Mosquitoes harboring the infective L3 stage brugian parasites were tested for the presence of human DNA to investigate their involvement in human brugian filariasis transmission. Statistical analyses were performed using generalized linear mixed models.
+
+Results
+
+A total of 766 mosquitoes of 15 species were dissected to obtain L3 larvae of the brugian parasite. Of these, 10.05% (n = 77) from nine species across four genera were identified to support the development of Brugia spp. to the infective L3 larval stage within the head and thoraces of field-caught mosquitoes: Mansonia annulifera, Ma. indiana, Ma. uniformis, Culex lophoceraomyia, Cx. tritaeniorhynchus, Cx. quinquefasciatus, Cx. vishnui, Armigeres subalbatus and Coquillettidia crassipes. Notably, Ma. indiana, which has not previously been identified as a potential vector for brugian filariasis in Sri Lanka, showed the highest weighted infectivity at the S1 site. Site-based risk assessment identified the S1 site as having the highest risk of brugian filariasis followed by S6.
+
+Conclusions
+
+Many mosquito genera supporting the development of Brugia spp. to the infective L3 larval stage in field-caught mosquitoes were identified expanding beyond the previously known Mansonia vectors. The diversity of potentially infective species indicates complex transmission dynamics requiring integrated surveillance approaches.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s13071-026-07264-w.
+
+Background
+
+Lymphatic filariasis (LF) in humans is a mosquito-borne neglected tropical disease (NTD) caused primarily by Wuchereria bancrofti, Brugia malayi and B. timori. Globally, over 657 million people are threatened across 39 endemic countries, including Sri Lanka [1]. Commonly observed symptoms include hydrocele and lymphoedema, which can progress to elephantiasis, characterized by massive swelling of the extremities. These symptoms are attributed to the inflammatory reaction caused by adult parasites residing within the lymphatic vessels, leading to damage and dysfunction of lymphatic vessels and predisposing individuals to lymphoedema. This makes LF one of the leading causes of permanent disfigurement and the second leading cause of long-term disability [2, 3]. The severe morbidity of this disease poses a significant socioeconomic burden, hindering the development of affected communities in developing countries [4–8]. Consequently, the estimated financial burden exceeds $5.8 billion annually, covering treatment costs, healthcare costs and potential income losses [9].
+
+In the past, both bancroftian filariasis and brugian filariasis (nocturnal periodic strain) were prevalent in Sri Lanka [10]. Before the LF elimination program, one-tenth of the inhabitants in the Sri Lanka's endemic regions were at risk of infection [11–14]. In the late 1960s, B. malayi was eliminated by removing the aquatic vegetation required for the known vector of the prevalent B. malayi strain to breed [10]. Following five successful mass drug administration (MDA) campaigns using diethylcarbamazine citrate (300 mg) combined with albendazole (400 mg) from 2002 to 2006, Sri Lanka received a certificate from the World Health Organization (WHO) in 2016 [15] for eliminating LF as a public health problem. However, post-elimination surveillance revealed the re-emergence of brugian filariasis, caused by what appears to be a variant of B. malayi [16–19].
+
+This variant exhibits a nocturnal sub-periodic behavior, differing from the previously eliminated anthroponotic periodic strain [16, 20]. Molecular analysis based on the internal transcribed spacer region 2 (ITS2) suggests it may represent a novel genetic variant or hybrid strain of B. malayi and Brugia pahangi [17]. Alarmingly, surveillance reports indicate that brugian infections outnumbered bancroftian infections in 2023, highlighting the urgency of understanding transmission dynamics to prevent the re-establishment of endemic transmission [19].
+
+Previous studies in Sri Lanka identified Mansonia uniformis and Ma. annulifera as competent vectors for the variant brugian strain [17], but a comprehensive assessment of the vector competence of the re-emerged variant is lacking, with only one study conducted in the Gampaha District, Sri Lanka [17]. Understanding vector competence for this variant is critical for several reasons; different parasite strains may have different vector competence patterns, post-elimination environmental changes may have altered vector populations, and effective vector surveillance and control strategies require knowledge of all competent vector species. This study aimed to assess the vector potentiality of mosquito species for brugian parasites across endemic districts in Sri Lanka, providing essential data for evidence-based surveillance and control strategies in the post-elimination era.
+
+Methods
+
+Study site selection
+
+Five districts along Sri Lanka’s LF belt with the most cases of Brugia infection detected by the Anti-filariasis Campaign (AFC) via thick blood smear (TBS) observations (2002–2021) were selected: Puttalam (53 cases), Kalutara (32 cases), Gampaha (23 cases), Galle (10 cases) and Colombo (6 cases). The most recently reported human case of Brugia infection in each district at the time of the study (April 2022) was identified, and the index house was selected as the study site in each district. Two sites were chosen from the Puttalam District because of the high case incidence. The selected mosquito collection sites were Puruduwella-Puttalam District (S1: 7.4898707, 79.859083), Maggona-Kalutara District (S2: 6.51012, 79.992529), Wattala-Gampaha District (S3: 6.99634, 79.89580), Induruwa-Galle District (S4: 6.3771134, 80.0171609), Boralesgamuwa-Colombo District (S5: 6.86579, 79.87821) and Mahawewa-Puttalam District (S6: 7.465026, 79.8697312) (Fig. 1).Fig. 1 Distribution of brugian filariasis cases in Sri Lanka and mosquito collection sites. Districts in the filariasis belt include Puttalam, Gampaha, Colombo, Kalutara, Galle and Matara. Locations of recent positive cases from each district are shown as a black dot; Puruduwella-Puttalam District (S1), Maggona-Kalutara District (S2), Wattala-Gampaha District (S3), Induruwa-Galle District (S4), Boralesgamuwa-Colombo District (S5) and Mahawewa-Puttalam District (S6). Districts are colored based on the human cases reported between 2006 and April 2021
+
+Mosquito collection
+
+A generalized workflow of the study is shown in Fig. 2. Mosquitoes were collected at S1 in October 2021, at S2 in December 2021, at S3 in February 2022, at S4 and S5 in June 2022 and at S6 in September 2022. Mosquitoes were collected using dog-baited traps, gravid traps and window traps to maximize species diversity and abundance in the mosquito samples. Mosquito collections were carried out over at least 2 consecutive nights at each location between 18:00 and 04:00 Sri Lankan Standard Time. Two of each trap type were installed at each study site to ensure consistency across study sites and to minimize sampling bias. For dog-baited traps, a dog was secured overnight within a white, rectangular, tent-like structure of nylon mesh (4 m × 3 m × 3 m), which was raised about 15 cm from the ground to allow mosquitoes to enter. The following morning, the dog was released, and the mosquitoes were collected using a mouth aspirator. Window traps measuring 56 cm × 56 cm × 46 cm [22] were placed outside the windows to collect anthropophilic mosquitoes exiting after a blood meal. The rest of the window was obstructed to ensure mosquitoes exited only through the opening leading to the trap. The trap was left in place overnight, and mosquitoes were collected using mouth aspirators the following morning. Gravid traps with attractants for Culex spp. were used to ensure their representation in the sample. An infusion of water and organic material (300 g fresh cow manure, 150 g Gliricidia leaves, 10 g yeast and 5 l water), fermented for 1–4 weeks, was placed in a 20 cm × 39 cm × 32 cm plastic dishpan with a motorized suction trap and left overnight. Mosquitoes were collected the following morning using a mouth aspirator and were transferred to holding containers. Although traps were left overnight for mosquito collection, all devices were designed to securely contain captured mosquitoes, preventing escape and thereby eliminating any risk of transmission from the dog-baited or window traps during the collection period. Mosquitoes were immobilized using chloroform to avoid physical damage, and head and thorax were dissected within 4 h to ensure detection of developing filarial larval stages within the mosquito tissues rather than microfilariae ingested during the most recent blood meal in the abdomen. The species of all the collected mosquitoes were identified using standard morphological keys [23, 24]. A subset of randomly selected mosquitoes was molecularly identified using the cytochrome c oxidase I (COI) region to validate the morphological identification.Fig. 2 Generalized work flow of the study
+
+Detection of infected and infective mosquitoes
+
+Mosquito dissection
+
+Female mosquitoes were held for 4 h post-collection to allow microfilariae ingested with the most recent blood meal to exit the midgut into the hemocoel, after which only the head and thorax were dissected to detect brugian parasites developed to the infective L3 larval stage. Each mosquito was placed on a slide under a binocular dissecting microscope (Leica LED3000, Germany), and the legs and wings were removed. The head and thorax regions were separated from the abdomen, placed in a separate drop of saline and dissected to identify potentially infective mosquitoes. Larval stages of the parasites were detected based on the morphological features and their movements (Table 1). The heads and thoraces of parasite-positive mosquitoes were stored separately for the molecular analysis of the brugian parasites, while the abdomens were stored separately for blood meal analysis at − 20 °C. Table 1 Features of the brugian parasites used for the differentiation of the larval stages [49]
+
+Features	Larval stage	
+L2	L3	
+Body size	Shorter and stouter	Longer and slender	
+Body shape	More curved or coiled	Mostly strait	
+Tail	Bluntly ended, not elongated	Pointed, elongated	
+Head	Less defined	Well defined	
+Body movements	Sluggish	Active	
+
+DNA extraction from parasite-positive mosquitoes
+
+DNA was extracted from the heads and thoraces, and from the abdomens separately, of the parasite-positive mosquitoes using the Blood and Tissue DNA extraction kit (Qiagen, Germany) following the manufacturer’s guidelines with the following modification: DNA was eluted twice into the same tube by adding 20 μl and 15 μl of nuclease-free water, respectively, in two subsequent steps and centrifuging at 8000 rpm for 1 min after each addition.
+
+Molecular confirmation of brugian infections
+
+The Brugia spp.-specific Hha1 region was amplified from the DNA extracts of the head and thorax regions of dissection-positive mosquitoes as previously described [25]. Briefly, primers 5′-GCGCATAAATTCATCAGC-3′ (forward) and 5′-GCGCAAAACTTAATTACAAAAGC-3′ (reverse) were used to amplify the 322-bp Hha1 repeat region of Brugia spp. The PCR amplification was performed in a 25 μl reaction volume containing 5.0 μl of 5 × PCR buffer, 0.5 μl (0.2 mM) dNTP, 0.2 μM of each primer, 1U Taq DNA polymerase and 2 μl of the extracted template DNA. The PCR cycle conditions included an initial denaturation step at 94 °C for 5 min, followed by 35 cycles each of denaturation at 94 °C for 1 min, annealing at 59 °C for 1 min and extension at 72 °C for 1 min, with a final extension at 72 °C for 10 min. The products were visualized by agarose gel electrophoresis on a 1.5% agarose gel, and brugian infections were identified based on the presence of a 322-bp band. Laboratory-raised B. malayi and B. pahangi samples obtained from the Filariasis Research Reagent Resource Center (FR3) at the University of Georgia, USA, were used as positive controls, and field-collected, molecularly confirmed Dirofilaria repens samples from the Faculty of Medicine, University of Kelaniya, Sri Lanka, were used as the negative control for this study.
+
+Positive PCR products from the mosquito head and thorax regions, which had concentrations sufficient for sequencing, were processed at the DNA sequencing facility at Iowa State University, USA, and Macrogen Inc., South Korea. The Basic Local Alignment and Search Tool (BLAST) on the National Centre for Biotechnology Information (NCBI) website was used to confirm the genus of the brugian parasites.
+
+Evidence of human blood feeding of potential brugian filariasis vectors
+
+To determine whether these mosquitoes are involved in the transmission of Brugia spp. to humans, the blood meals of the infected and potentially infective mosquitoes were analyzed for human blood. DNA was extracted from the abdomens of parasite-positive mosquitoes obtained from the dissections to analyze the blood meal [26]. The 272-bp cytochrome c oxidase I (COI) region of the mitochondrial genome of humans was amplified using HMNF’-CTCGGCTTACTTCTCTTCC with the universal reverse primer UNVR’-AGTGGGYGRAATATTATGC. The PCR mixture was heated for 5 min at 95 °C, followed by 12 cycles of 94 °C for 30 s, 57 °C for 30 s and 72 °C for 50 s. Two additional sets of 12 cycles each followed, using decreasing annealing temperatures of 56 °C and 55 °C, respectively. A final elongation at 72 °C was performed for 5 min.
+
+Statistical analysis
+
+All statistical analyses and visualizations were conducted using R 4.5.1 [27]. To assess interspecific differences in infection potential of mosquito species of brugian filariasis (Model 1) and human brugian filariasis (Model 2), we fitted two generalized linear mixed models (GLMMs) using the “glmmTMB” package with a gamma distribution and log link function using weighted indices with mosquito species included as a fixed factor in both models [28]. The approach of Kilpatric et al. was adapted with modifications to accommodate the objectives of the present study [29]. An index of vector competence was not incorporated, as relevant species-specific data were not tested experimentally.
+
+Model 1.
+
+The response variable was the weighted potentially infective (WPI) percentage calculated for each mosquito species as:WPI=PixArx100e
+
+where
+
+Pi = proportion of potentially infective mosquitoes of the relevant species.
+
+Ar = relative abundance of the relevant species.
+
+Model 2.
+
+The response variable was the weighted probability of potentially infective mosquitoes with human blood (WPIH) calculated for each mosquito species at each site as:WPIH=PixArxPhbx100e
+
+where
+
+Pi = proportion of potentially infective mosquitoes of the relevant species at the relevant site.
+
+Ar = relative abundance of the relevant species at the relevant site.
+
+Phb = proportion of potentially infective mosquitoes of the relevant species with human blood at the relevant site.
+
+Model significances were evaluated using the ANOVA function in the “car” package [30]. Post hoc pairwise comparisons of estimated marginal means (EMMs) were performed using the “emmeans” package with Tukey’s adjustment for multiple testing [31], and species-specific weighted potential infective percentages and predicted probabilities of infectivity and presence of human blood were extracted. The predicted values with 95% confidence intervals were visualized as bar plots, and the weighted potential infectivity of mosquitoes with human blood percentages were illustrated with the “ggplot2” package [32].
+
+A generalized linear mixed model was fitted to the “glmmTMB” package to test the effects of mosquito species, site and their interaction on both weighted indices with a Tweedie distribution with a log link function. Model significance was assessed using ANOVA. Estimated marginal means for each species-site combination was obtained using the emmeans package, and pairwise comparisons were adjusted with Tukey’s method. Non-estimable contrasts were excluded prior to post hoc analysis.
+
+Results
+
+Adult mosquito distribution and species diversity
+
+A total of 794 mosquitoes from 15 species were captured throughout the study (Table 2). Of these, 62.7% (n = 498), 27.1% (n = 215) and 10.2% (n = 81) mosquitoes were found in dog-baited, gravid and window traps, respectively. The highest number of species (n = 14) was recorded from dog-baited traps, while seven and eight species were collected from gravid and window traps, respectively. All three types of traps captured Mansonia annulifera, Ma. indiana, Ma. uniformis, Culex quinquefasciatus and Armigeres subalbatus. In contrast, Culex lophoceraomyia, Culex vishnui, Aedes aegypti, Aedes pipersalatus and Anopheles kawani were found only in dog-baited traps, and Culex eumelanomyia brevipalpis was found only in window traps. The most Culex spp. mosquitoes were found in gravid traps. Damaged specimens were discarded, resulting in 766 mosquitoes being included in the analysis. Table 2 Mosquito species collected using dog-baited (12), gravid (12) and window (12) traps operated from October 2021 to September 2022
+
+Type of trap	Dog-baited trap	Window trap	Gravid trap	
+Mosquito species	
+Mansonia annulifera	12	1	2	
+Ma. indiana	50	6	2	
+Ma. uniformis	93	5	1	
+Culex gelidus	1	0	1	
+Cx. lophoceraomyia	4	0	0	
+Cx. tritaeniorhynchus	89	0	29	
+Cx. quinquefasciatus	25	35	172	
+Cx. vishnui	2	0	0	
+Cx. eumelanomyia brevipalpis	0	3	0	
+Aedes aegypti	2	0	0	
+Ae. albopictus	40	5	0	
+Ae. pipersalatus	1	0	0	
+Armigeres subalbatus	167	23	8	
+Anopheles kawani	5	0	0	
+Coquillettidia crassipes	7	3	0	
+Total	498	81	215	
+
+Detection of infected and potentially infective mosquito species
+
+The ability of brugian parasites to develop into the infective L3 larval stage within the collected mosquito species was assessed to identify potential vectors of brugian filariasis. Mosquitoes harboring L1, L2 or L3 life stages within the head and thorax regions were identified as infected; of these, those harboring L3 parasites were identified as potentially infective because of the ability to support development to the infective stage within the vector.
+
+Of the 15 species of mosquitoes caught, Ma. annulifera, Ma, indiana, Ma. uniformis, Cx. lophoceraomyia, Culex tritaeniorhynchus, Cx. quinquefasciatus, Cx. vishnui, Ae. aegypti, Ar. subalbatus and Coquillettidia crassipes species (n = 10) were infected, and all but Ae. aegypti were potentially infective (Fig. 3), suggesting their potential to serve as vectors of brugian filariasis in Sri Lanka.Fig. 3 Additional mosquito species identified as potential vectors for brugian filariasis. a Number of mosquitoes identified with brugian infections by the presence of brugian parasites upon dissections, confirmed via PCR. The percentage of potentially infective mosquitoes of each species out of the total collection is represented on the bars. b Predicted weighted potential infectivity as a percentage of the total potentially infective mosquito species. The error bars represent SE. The compact letters indicate statistically significant differences among species based on pairwise comparisons (p < 0.05)
+
+The GLMM showed significant differences in potential infectivity probability among mosquito species (χ2 = 24,377, df = 9, p < 0.001). Weighted infective capability varied significantly among mosquito species. Culex tritaeniorhynchus (n = 22, 19%, mean ± SD = 0.00384 ± 0.00004), followed by Ma. indiana (n = 19, 34%, mean ± SD = 0.00332 ± 0.00005), were identified as the species with the highest predicted weighted potential infectivity percentages (Additional file 1). Compared with other potentially infective species, Ar. subalbatus harbored the most L1- and L2-stage brugian parasites (n = 11, 4.6%) in addition to a considerable number of L3 stage parasites (n = 10, 4%). This may reflect a transitional period in which Ar. subalbatus is being manipulated by the brugian parasite to support its development to the infective stage. Mansonia annulifera, Cx. lophoceraomyia and Cx. vishnui exhibited comparatively lower predicted weighted potential infectivity percentages. Mosquito species where no brugian parasites were detected were eliminated from further analysis.
+
+Evidence of human blood feeding of potential brugian filariasis vectors
+
+To examine the potential involvement of mosquito species capable of transmitting human brugian filariasis, they were tested for traces of human DNA. Human blood was detected in all the potentially infective species except Cx. vishnui, suggesting their potential in transmission of human brugian filariasis (Fig. 4). Interestingly, the highest potential infectivity percentage with human blood was found in Ma. indiana (ninfected = 20, ninfective with human DNA = 19, mean ± SD = 0.00338 ± 0.00005) followed by Cx. tritaeniorhynchus (ninfected = 13, ninfective with human DNA = 11, mean ± SD = 0.00196 ± 0.00002) (Additional file 2). As the two species with the highest percentage of potentially infective mosquitoes with human DNA, Ma. indiana and Cx. tritaeniorhynchus could potentially serve as vectors of human brugian filariasis in Sri Lanka in addition to the already established Ma. annulifera and Ma. uniformis vectors.Fig. 4 Potential brugian vectors showed evidence of human blood feeding. a Presence of human blood in infected mosquitoes. Of the infected mosquitoes of each species, potentially infective mosquitoes detected with human blood are represented as a percentage on the bars. b Predicted weighted potential infectivity as a percentage of the total potentially infective mosquito species with human blood. The error bars represent SE. The compact letters indicate statistically significant differences among species based on pairwise comparisons (p < 0.05)
+
+Site-based risk analysis of brugian filariasis
+
+Mosquito species in which brugian parasites were detected (Fig. 3) were further analyzed to assess their spatial distribution. A site-wise analysis of the abundance of Brugia-positive mosquito species and total percent infectivity was carried out (Fig. 5a). Furthermore, to identify the dominant species and evaluate the risk of brugian filariasis at each site, the percentages of infected and infective mosquitoes (Fig. 5b) were calculated. To investigate the risk of transmission of human brugian filariasis at each site, infected and potentially infective mosquito species were assessed for human DNA across the six sites (Fig. 5c).Fig. 5 Risk analysis between the study sites. Puruduwella-Puttalam District (S1), Maggona-Kalutara District (S2), Wattala-Gampaha District (S3), Induruwa-Galle District (S4), Boralesgamuwa-Colombo District (S5) and Mahawewa-Puttalam District (S6). a Heat map of the distribution of the mosquitoe species in which brugian parasites were detected. b Site-wise species distribution of potentially infective mosquitoes. Potentially infective mosquitoes of each species are represented as a percentage of the dissected mosquitoes on the bars. c Distribution of infected mosquito species with human blood. Potentially infective mosquitoes of each species are represented as a percentage of infected mosquitoes on the bars
+
+The total abundance of Brugia-positive mosquito species was highest at S2 (n = 213) and S3 (n = 150), closely followed by S1 (n = 132) and S6 (n = 127), and lowest at S4 (n = 55), with the highest percentage of potentially infective mosquitoes at S1 (n = 36, 27.3%) and S6 (n = 20, 15.7%). Of the nine species identified as potentially infective, S1 was the most species-rich site (n = 8), followed by S6 (n = 5). Interestingly, all the species at S1 and S6 were potentially infective, with Ma. indiana having the most potentially infective mosquitoes at S1 (n = 18, 33%), followed by Cx. tritaeniorhynchus (n = 29, 41%). The GLMM results showed significant effects of both mosquito species and site on the weighted potential infectivity index. The effects of species (χ2 = 586.72, df = 8, p < 0.001), site (χ2 = 689.32, df = 5, p < 0.001) and their interaction (χ2 = 700.13, df = 15, p < 0.001) were all significant. Regarding potential infectivity, Ma. indiana and Cx. tritaeniorhynchus from S1 and Cx. tritaeniorhynchus from S6 showed the highest weighted values for potentially infective mosquitoes, where differences were significant (p < 0.001). In contrast, Ar. subalbatus, Ma uniformis and Ma. annulifera generally showed lower infectivity across most sites.
+
+Human blood was detected in all potentially infective species at S1 except Cx. vishnui with the highest proportion detected in Ma. indiana (n = 18, 95%), followed by Cx. tritaeniorhynchus (n = 8, 80%,). Significant differences were observed among mosquito species (χ2 = 599.59, df = 8, p < 0.001), among sites (χ2 = 2000.02, df = 5, p < 0.001) and for the species-site interaction (χ2 = 987.76, df = 15, p < 0.001) when considering the weighted number of mosquitoes with human blood. This suggests that the proportion of potential vectors with human blood varied substantially among mosquito species and across sites, with significant spatial heterogeneity in species-specific responses.
+
+Pairwise comparisons showed significant variation in both the weighted potential infectivity of mosquitoes with human blood and across sampling sites. Accordingly, Ma. indiana (p < 0.001) followed by Cx. tritaeniorhynchus (p < 0.001) from S1 can be identified as potential vectors for human brugian filariasis. Human blood was detected in three of the four potentially infective species at S6 (n = 4, 20%). However, the number of mosquitoes of individual species is insufficient to identify potential vectors at S6.
+
+Although the total abundance was highest at S2 and S3, the percentage of infectivity was low (S2 = 5.6%, S3 = 1.3%), with no human blood being detected in infective mosquitoes at S2. These data collectively suggest that S1 is at the highest risk of transmission of human brugian filariasis, followed by S6, with Ma. indiana and Cx. tritaeniorhynchus potentially serving as additional vectors at S1.
+
+Discussion
+
+Brugian filariasis has re-emerged in Sri Lanka after 4 decades of quiescence, with an increase in disease incidence in 2023. The absence of a definitive cure for LF in its advanced stages underscores the critical importance of prevention strategies, particularly through effective vector control and MDA. This study aimed to identify potential vectors of brugian filariasis in Sri Lanka to support targeted vector control measures.
+
+Here, we present evidence of infection and development of brugian parasites to the infective L3 larval stage in field-caught Ma. annulifera, Ma. indiana, Ma. uniformis, Cx. lophoceraomyia, Cx. tritaeniorhynchus, Cx. quinquefasciatus, Cx. vishnui, Ar. subalbatus and Cq. crassipes in Sri Lanka. To date, only Ma. annulifera and Ma. uniformis have been reported as potential vectors for brugian filariasis in Sri Lanka [17, 21, 33]. The presence of infective brugian parasites in field-caught Ma. indiana, Cx. lophoceraomyia, Cx. tritaeniorhynchus, Cx. quinquefasciatus, Cx. vishnui, Ar. subalbatus and Cq. crassipes species have not been reported in Sri Lanka [17, 21, 33] and Cx. lophoceraomyia, Cx. quinquefasciatus and Cx. vishnui in the world [34–41]. To our knowledge, this is the first study in Sri Lanka to systematically collect mosquitoes using multiple collection methods to ensure maximum species diversity in the collection, enabling the detection of a broader range of potentially infective vector species.
+
+This study reports an unusually higher number of Ma. indiana mosquitoes compared with previous studies in Sri Lanka. Two studies, which analyzed 82 and 1060 mosquitoes respectively, reported three and two Ma. indiana mosquitoes, none of which were infected with the brugian parasite [17, 33], and no Ma. indiana mosquitoes were reported in the survey conducted over 6 consecutive months, in which nearly 7000 mosquitoes were analyzed [21]. Vector studies on brugian filariasis are scarce in Sri Lanka, where only the above three studies have been conducted, and all three were carried out in the Gampaha District. Our results of the study site in Gampaha align with the results of the above studies where, of the 150 mosquitoes collected, only two Ma. indiana mosquitoes were present; however, both were infected with brugian parasites. The high abundance of Ma. indiana observed in this study may be attributable to extending the study beyond the Gampaha District, allowing for the identification of geographical pockets of certain species. Furthermore, seasonal climatic factors and favorable environmental conditions at the time of sampling could have influenced the presence of brugian parasites within these mosquitoes; however, these parameters were beyond the scope of the present study and were not formally evaluated. However, Ma. indiana has been reported in abundance in filariasis-endemic areas in other countries and has been reported as a potential vector for filariasis in Thailand, Malaysia and Indonesia [35–37]. Studies have shown its capacity to transmit nocturnally sub-periodic B. malayi parasites [36], supporting its role as a potential vector for brugian filariasis. Culex tritaeniorhynchus and Ae. albopictus have been reported as vectors of B. malayi in Indonesia [37], while Ar. subalbatus has been identified as a vector for zoonotic B. pahangi in Thailand [38] and Malaysia [38, 39] and Cq. crassipes as a vector for B. malayi in Malaysia [36].
+
+Interestingly, the presence of infective L3 Brugia spp. larvae in field-caught Cx. lophoceraomyia, Cx. quinquefasciatus and Cx. vishnui has not been reported elsewhere thus far. In 1995, Bangs et al. reported the susceptibility of Culex tarsalis and Culex erythrothorax to sub-periodic B. malayi through laboratory experiments, thereby providing evidence for the ability of the genus Culex to act as a vector for brugian filariasis [44]. Interestingly, some laboratory experiments demonstrated the complete refractoriness of Culex sitiens to sub-periodic B. malayi [38], and the mid-gut was shown to act as a barrier against brugian filarial parasites in Cx. pipiens pipiens [45]. However, a study done by Erickson et al. reported the presence of filarial DNA within the head region of Cx. pipiens [46]. Ughasi et al. reported the possibility that mosquito species previously considered non-vectors could act as vectors of filariasis parasites over generations [47]. This may reflect a parasite with genetic modifications, which requires further investigation. Detection of human blood in potentially infective Ma. annulifera, Ma. indiana, Ma. uniformis, Cx. lophoceraomyia, Cx. tritaeniorhynchus, Cx. quinquefasciatus, Ar. subalbatus and Cq. crassipes suggests a potential role of these species in the transmission of human brugian filariasis.
+
+The S1 site was identified as the area with the highest risk regarding human brugian filariasis at the time of the study, when considering abundance, species richness of Brugia-positive mosquitoes, percentages of potentially infective mosquitoes and the proportion of them with traces of human blood. Incidentally, the S1 site is in the Puttalam District, which had the highest disease incidence (53 cases) from 2001 to 2021, as identified through human blood TBS observations by the AFC. Interestingly, Ma. indiana was by far the most prevalent and potentially infective mosquito species at study site S1, closely followed by Cx. tritaeniorhynchus. With a high abundance, a high percentage of infectivity and the presence of human blood within them, Ma. indiana and Cx. tritaeniorhynchus could potentially contribute to the transmission of human brugian filariasis in these areas. Their absence in S4 and S5 and low infectivity percentages of infectivity in S2 and S3 could have been reasons for the low disease incidence (S2 = 32, S3 = 23, S4 = 10, S5 = 6) in these areas at the time of the study.
+
+The presence of infective mosquitoes and a high abundance of potential vector species at S2 suggests the potential for transmission of brugian filariasis. However, the low percentage of infectivity of these mosquitoes and the absence of human blood within them could be suggestive of a zoonotic brugian filariasis in the area or a recent introduction of brugian filariasis to the area and, therefore, the initial stages of transmission at the time of the study. Although human brugian filariasis has not yet been detected within the S2 study site, the presence of the potential vector species indicates the risk of developing new cases of human brugian filariasis within this site.
+
+In the current study, the entire mosquito catch was analyzed for brugian infections by dissection. However, currently, in the national vector surveillance program of the AFC, only Ma. annulifera and Ma. uniformis (previously known vector for brugian filariasis) mosquitoes are dissected for brugian filariasis infections, since Ma. indiana has not been found so far. Mosquitoes are dissected for brugian filariasis infections and pooled for PCR to detect brugian infections. The identification of new potential vectors suggests the importance of extending the xenomonitoring efforts to other species for a comprehensive analysis of the situation.
+
+However, the current survey is not ideal for comparing the geographical distribution of vectors, as seasonal variation also plays an important role in determining mosquito populations. The survey was not conducted in comparable climatic seasons; mosquitoes were collected during the inter-monsoon season at S1 and during the monsoon season at S2-S6. Therefore, conducting mosquito collections in comparable seasons would help reveal the true geographical and seasonal patterns of potential vector distribution across the sites. Furthermore, the present study was intended to provide site-specific baseline entomological evidence following LF elimination in Sri Lanka and was not designed to support extrapolation beyond the study area. Nevertheless, it constitutes the first national-level effort to evaluate all mosquito species collected for potential vector status.
+
+In the present study, mosquitoes carrying L3 larvae were identified as potentially infective because of the ability of those species to support the development of the parasites to the infective stage. However, Gleave et al. demonstrated the inability of certain mosquitoes to transmit the disease [48]. Therefore, the mosquito species identified in this study as potential vectors of brugian filariasis should undergo further validation through experimental vector competence studies. Such follow-up research is essential to accurately determine the role of these mosquito species in the transmission of brugian filariasis and to guide targeted vector control strategies. Data generated by the current study could be used to refine prevention and control strategies by developing more tailored vector control measures in Sri Lanka and other brugian filariasis-endemic countries. Such measures are crucial in preventing the potential resurgence of the disease.
+
+The identification of new potential vector species for brugian filariasis, including several not previously reported in Sri Lanka or globally, reveals significant shifts in the local vector ecology and transmission dynamics. Incorporating multidisciplinary surveillance combining entomological, ecological and molecular data will be essential to detect emerging vector species, assess their public health significance and design context-specific control strategies. Such integrated efforts are critical for achieving sustainable elimination of human brugian filariasis.
+
+Conclusions
+
+This study demonstrates that brugian parasites are present in a wide range of mosquito species in post-elimination Sri Lanka, with seven species across four genera capable of supporting parasite development to the infective stage. The identification of Ma. indiana as a highly competent species in Sri Lanka represents a novel finding with significant epidemiological implications. These findings provide essential baseline data for evidence-based vector control strategies in Sri Lanka’s post-elimination LF program. Nonetheless, gaps in knowledge remain regarding the natural transmission capacity, seasonal variations and vector-parasite interactions under field conditions. The diversity of competent species suggests complex transmission dynamics that require comprehensive, adaptable surveillance strategies to prevent the re-establishment of endemic transmission. Future research priorities include experimentally validating vector competence, conducting seasonal surveillance and assessing natural transmission capacities, especially with Ma. indiana and Cx. tritaeniorhynchus, for the transmission of brugian filariasis.
+
+Supplementary Information
+
+Additional file 1.
+
+Additional file 2.
+
+Abbreviations
+
+LF Lymphatic filariasis
+
+MDA Mass drug administration
+
+AFC Anti-filariasis campaign
+
+TBS Thick blood smear
+
+ITS2 Internal transcribed spacer region 2
+
+BLAST Basic Local Alignment and Search Tool
+
+NCBI National Centre for Biotechnology Information
+
+GLMM Generalized linear mixed models
+
+EMM Estimated marginal mean
+
+WPI Weighted potential infectivity
+
+WPIH Weighted potential infectivity percentage of mosquitoes with human blood
+
+Acknowledgements
+
+The authors acknowledge the support provided by the staff of the Anti-filariasis Campaign, especially Ms. Lakmini, the staff of the Regional Director of Health Services branches at Madampe, Colombo, Kalutara and Galle, the staff of the Department of Entomology at the Medical Research Institute, and Mr. Lahiru Herath for supporting the field study. We also thank Dr. Dayananda at the University of Sri Jayewardenepura for support.
+
+Author contributions
+
+Conceptualization: HH, BGDNKdS, NdS and NC; methodology: SUN, HH, BGDNKdS and NC; investigation and formal analysis: SUN, HH, TSN; writing-original draft: SUN and HH; writing-review and editing: HH, BGDNKdS, NC, NdS, MK; funding acquisition: BGDNKdS, and HH; supervision: BGDNKdS, HH, NC, NdS, MK, and CHM. All authors read and approved the final manuscript.
+
+Funding
+
+National Research Council (grant no. 19-028) and ASP/01/RE/SCI/2022/31 grant of the University of Sri Jayewardenepura.
+
+Data availability
+
+Data supporting the main conclusions of this study are included in the manuscript.
+
+Declarations
+
+Ethics approval and consent to participate
+
+This cross-sectional study was conducted across six sites in five districts with the most cases of Brugia infection. The study was approved by the Ethics Review Committee of the University of Sri Jayewardenepura (ASP/01/RE/SCI/2022/31), Sri Lanka, and the Institute of Biology (ERC-IOBSL) (reg. no. ERC-IOBSL 206 02 2020).
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+Eneanya OA, Garske T, Donnelly CA. The social, physical and economic impact of lymphedema and hydrocele: a matched cross-sectional study in rural Nigeria. BMC Infect Dis. 2019;19:1–16.31014256 10.1186/s12879-019-3959-6 PMC6480436
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+Mathew CG, Bettis AA, Chu BK, English M, Ottesen EA, Bradley MH, et al. The health and economic burdens of lymphatic filariasis prior to mass drug administration programs. Clin Infect Dis. 2020;70:2561–7.31343064 10.1093/cid/ciz671 PMC7286370
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+Yahathugoda TC, Wickramasinghe D, Weerasooriya MV, Samarawickrema WA. Lymphoedema and its management in cases of lymphatic filariasis: the current situation in three suburbs of Matara, Sri Lanka, before the introduction of a morbidity-control programme. Ann Trop Med Parasitol. 2005;99:501–10.16004709 10.1179/136485905X46450
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+Chiang GL, Samarawickrema WA, Mak JW, Cheong WH, Sulaiman I, Yap HH. Field and laboratory observations on Coquillettidia crassipes in relation to transmission of Brugia malayi in Peninsular Malaysia. Ann Trop Med Parasitol. 1986;80:117–21.2873797 10.1080/00034983.1986.11811989
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+Sarataphan N, Phantana S, Chansiri K. Susceptibility of Mansonia indiana (Diptera: Culicidae) to nocturnally subperiodic Brugia malayi (Spirurida: Filariodea). J Med Entomol. 2002;39:215–7.11931259 10.1603/0022-2585-39.1.215
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+Prummongkol S, Panasoponkul C, Apiwathnasorn C, Lek-Uthai U. Refractoriness of Culex sitiens to experimental infection with nocturnal subperiodic Brugia malayi. J Trop Med Parasitol. 2009;32:82–8.
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+Muslim A, Fong MY, Mahmud R, Lau Y, Sivanandam S. Armigeres subalbtus incriminated as a vector of zoonotic Brugia pahangi filariasis in suburban Kuala Lampur, Penninsular Malaysia. Parasit Vectors. 2013;6:1–5.23898840 10.1186/1756-3305-6-219 PMC3750234
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diff --git a/corpus/healthcare/text/6817054eba24964d.txt b/corpus/healthcare/text/6817054eba24964d.txt
new file mode 100644
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@@ -0,0 +1,611 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Immigr Minor Health
+Journal ID: J Immigr Minor Health
+NLM Journal ID: 101256527
+
+Journal of Immigrant and Minority Health
+
+ISSN: 1557-1912
+EISSN: 1557-1920
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12669293
+PMID: 40587049
+DOI: 10.1007/s10903-025-01722-w
+Article ID: 1722
+Article version: 1
+Subjects: Review Paper
+
+Healthcare Access and Outcomes for Refugee Women in Transit: A Scoping Review of Facilitators and Barriers in South and Southeast Asia
+
+Fernando Gabriela gabriela.fernando@monash.edu
+1
+Khafiyya Asiyah Nida 2
+Tricesaria Anak Agung Istri Diah 3
+Watterson Jessica 4 5
+Puspita Sabina Satriyani 6
+1 Public Health, Monash University, Banten, Indonesia
+2 https://ror.org/00c7fav87 grid.449547.f 0000 0000 9331 2695 Public Health Department of Community Medicine, Faculty of Medicine, Universitas Islam Negeri Syarif Hidayatullah Jakarta, Banten, Indonesia
+3 https://ror.org/02bfwt286 grid.1002.3 0000 0004 1936 7857 Human Geography, Anthropology and Development Studies Department, School of Social Sciences, Faculty of Arts, Monash University, Melbourne, Australia
+4 https://ror.org/02czsnj07 grid.1021.2 0000 0001 0526 7079 School of Health and Social Development, Deakin University, Melbourne, Australia
+5 https://ror.org/026wwrx19 grid.440439.e 0000 0004 0444 6368 Jeffrey Cheah School of Medicine and Health Sciences, Monash University, Kuala Lumpur, Malaysia
+6 Public Policy and Management, Monash University, Banten, Indonesia
+Electronic publication date: 2025 Jun 30
+Print publication date: 2025
+Volume: 27
+Issue: 6
+First page: 1051
+Last page: 1073
+Accepted 2025 Jun 22
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Transit refugees, Women’s health, Healthcare access, Health equity, Migration
+
+Funding: Monash University, Indonesia
+
+Funding: Monash University Open Access funding enabled and organized by CAUL and its Member Institutions
+
+issue-copyright-statement: © Springer Science+Business Media, LLC, part of Springer Nature 2025
+
+Ÿ==============================Ÿ
+Forced displacement has reached unprecedented levels globally, with women and girls comprising over half of the refugee population. In South and Southeast Asia, transit refugee women face unique health challenges, yet their health experiences and needs remain underexplored and underserved. This review explores the existing evidence on the health experiences and healthcare access of transit refugee women in these regions. A search was conducted using PubMed [MEDLINE], Scopus, Google Scholar, alongside UNHCR, WHO, and IOM databases between October 2023 and January 2024. Peer-reviewed and grey literature published from 2013 to 2024 that analysed health outcomes and experiences of transit refugee women in South and Southeast Asia were included. A narrative synthesis was used to identify the major themes related to the health outcomes and healthcare access of transit refugee women. Fourteen articles met the inclusion criteria, of which a majority of the studies were from Bangladesh, Thailand-Myanmar border, and Malaysia, mainly drawing insights from Rohingya, Karen, and Chin communities. Key health issues included sexual and reproductive health, including family planning, contraceptive use, HIV transmission, sexual and gender-based violence, and mental health. Distance and availability of health services, spousal consent for health-seeking, out-of-pocket health expenditure, cultural and religious beliefs, and stigmatization were barriers to accessing healthcare. These barriers may contribute to foregoing contraceptive usage, poor family planning, poor HIV-related health knowledge transmission, high psychological distress, and poor mental health outcomes. However, targeted interventions such as having the UNHCR card, the availability of health clinics within camps, recruiting female health workers, provision of counselling and health education programs, can positively influence health outcomes, healthcare seeking and utilization behaviours, and health knowledge transmission. Transit refugee women in South and Southeast Asia face significant challenges due to unmet health needs and limited healthcare access. These insights highlight the need for future health research, programs and policy action to better integrate targeted, gender-responsive interventions that can enhance health access of this vulnerable subgroup regionally.
+
+Background
+
+Globally, one in eight individuals is currently a migrant or forcibly displaced [1]. By the end of September 2023, a record 114 million people were displaced by war, persecution, human rights violations, and environmental crises [2]. South and Southeast Asia serve as critical transiting hubs connecting countries of origin to final destinations for millions of refugees fleeing from such atrocities. Over 280,000 refugees are residing across Malaysia, Thailand, and Indonesia and over 1.3 million reside in Bangladesh and India [3–5]. Despite the significant role of these regions in global migration pathways, there remains a dearth of research and policy focusing on the health and healthcare access of transit refugees, particularly for women who face disproportionate exposure to health and social risks [6, 7].
+
+Women Refugees in Transit: A Vulnerable and Overlooked Subgroup
+
+While there is no universal definition categorizing this subgroup, transit refugees are individuals who, having fled their country of origin, are temporarily displaced while awaiting resettlement or asylum in a final host country. This subgroup differs from asylum seekers, who are awaiting a decision on their asylum application, and resettled refugees, who have been granted protection in a third country [8]. It also includes individuals whose legal documentation has expired, leaving them in a prolonged state of uncertainty and vulnerability, often with limited access to formal protection, legal rights and services. Despite the implication of short-term retention suggested by the terms ‘transit’ and ‘transit routes’, studies reveal that this period can extend from several months to several years [9–11].
+
+Studies have highlighted that refugees face distinct vulnerabilities at each stage of migration—pre-departure, during the journey, in transit, and in host countries—with the transit context significantly heightening risks of exploitation, kidnappings, torture and sexual violence, and severe mental and physical trauma and health inequities, particularly for women [10, 12]. These risks are further compounded by gendered barriers and systemic neglect within transit contexts, including a lack of- or poor living conditions, with some living within detention camps and others in blended community contexts, often with little access to legal recourse or health and psychological support.
+
+Sexual and reproductive health and rights (SRHR) are often neglected due to inadequate health systems’ responses in transit regions, alongside cultural or legal constraints, with women frequently encountering barriers to accessing contraception, with complications from cultural practices such as female genital mutilation (FGM) and consequential obstetric health complications, poor maternal health services, unsafe abortions, and increased incidences of sexually transmitted infectious (STIs) [7, 13, 14]. Moreover, studies have reported that between men and women, transit conditions exacerbate the risk of sexual and gender-based violence (SGBV) for women, with every one in five women refugees experiencing forms of violence, including sexual assault, exploitation, and intimate partner violence [15–17]. Factors such as age of migration, marital status, and days of preparation for the travel (a measure of suddenness of departure) are found to be associated with the risk of exposure and vulnerability of girls and women, particularly in relation to SGBV [17, 18]. Consequently, these vulnerabilities have contributed to surging rates of child marriage and teenage pregnancies within these transit environments [19].
+
+Chronic health conditions, such as diabetes and hypertension, are also poorly managed due to disruptions in care, lack of medications, and prioritization of acute health needs in crisis settings [20, 21]. Mental health challenges are pervasive, with women transit refugees reporting high levels of trauma, depression, and suicidal ideation, often compounded by stigma and the absence of culturally sensitive mental health services [10, 22]. While the relationship between women’s chronic health conditions and mental health challenges has not been explicated, untreated chronic health conditions may factor in women’s mental health challenges and vice versa [23].
+
+Emergence of Global Evidence Versus Evidence Gaps in South and Southeast Asia
+
+Emerging evidence and policy innovation focus on transit contexts in predominantly Europe and the Mediterranean. Health programming and policies in these regions have begun addressing health inequities and expanding access to healthcare, particularly for women refugees in transit [24]. However, similar efforts in South and Southeast Asia remain sparse, creating a significant gap in addressing the needs of this highly vulnerable population. This gap is further exacerbated by the fact that the majority of South and Southeast Asia countries are not signatories to the 1951 Refugee Convention or its 1967 Protocol, leaving refugees vulnerable to exploitation, limited access to services, and uncertain legal status. It also places significant strain on national capacities for hosting, financing, and delivering services to meet the needs of refugees, particularly those in transit, as well as host populations.
+
+A study by Quigley et al. [25] that focused on the health system challenges and responses of refugees across Indonesia, Malaysia, Myanmar and Thailand noted that financial, juridico-political and sociocultural barriers, alongside the lack of national commitment to universal health coverage (UHC), contribute to unmet health needs. These include significant mental trauma, untreated chronic conditions, starvation and malnutrition, exposure to infectious diseases such as tuberculosis due to conditions of detention camps, and injury from abuse and sexual violence. The study also highlights the role of NGOs and community-based organizations in providing health services, advocacy, and education to refugee populations. Yet, despite the increasing use of these regions as transit hubs, the specific health needs and healthcare access challenges faced by these transit refugee women remain underexplored.
+
+Therefore, utilizing a narrative synthesis, this review aims to scope the existing evidence to explore the health outcomes, healthcare access and experiences of refugee women in transit across South Asia and Southeast Asia. By highlighting these issues, the review seeks to inform future health interventions and policy action, contributing to more effective support systems for refugees in perilous transit conditions, both regionally and globally.
+
+Positionality Statement
+
+None of the authors involved in this review were refugees themselves. The authors were faculty in Schools of Public Health, Medicine and Health Sciences, and Public Policy, as well as a graduate student in the School of Social Sciences. Most authors work and engage with private and urban universities in South and Southeast Asia, including in Australia. Most authors identify as women, and have direct experience working with the refugee population in Indonesia. The authors believe that including this positionality statement, despite this article being a literature review, is essential to respecting the agency of refugees and critically reflecting on their own biases.
+
+Methods
+
+Search Strategy and Selection Criteria
+
+The search was conducted between October 2023 and January 2024, across multiple databases, including PubMed [MEDLINE], Scopus, Google Scholar, and the e-libraries of the International Organization for Migration (IOM), World Health Organization (WHO), and United Nations High Commissioner for Refugees (UNHCR). The search focused on peer-reviewed articles only in English language that analysed the health outcomes and experiences of adult refugee women (18 + years of age) with transit status residing across South Asia (List of countries by World Bank categorization: Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, and Afghanistan) and Southeast Asia (List of countries by World Bank categorization: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam). The articles were also restricted to those published after 2013 to date. Articles published after 2013 are included to capture the evolving discourse around refugee and migrant policies in the lead up to and following the adoption of the UN General Assembly’s New York Declaration for Refugees and Migrants in 2016 [26]. This period reflects key shifts in global frameworks and responses to refugee and migration crises.
+
+A list of predetermined key terms using a combination of MeSH and non-MeSH terms that captured ‘transit refugee’, ‘health access’ and various ‘health outcomes’, ranging from infectious diseases, sexual and reproductive health and rights, maternal health, physical injuries, non-communicable diseases, mental health, and gender-based violence, from relevant public health literature and the WHO’s Global Action plan on promoting the health of refugees and migrants [27] (see Appendix). Two reviewers (AK and GF) developed the list of search terms and the eligibility criteria, and Boolean operators were used to combine these terms in the search.
+
+Data Extraction
+
+In the initial screening phase, titles and abstracts of identified articles were screened based on the predefined eligibility criteria (see Table 1). Articles that met the criteria or showed potential for meeting them were advanced to a full-text screening stage. In this subsequent phase, each article was carefully reviewed to ensure full compliance with the eligibility criteria. Only those that were relevant to the review topic and focused on the specified health outcomes were included in the final review. Key indicators such as publication year, country and region, sample size, study design, and key outcomes were manually extracted from each article. Five independent reviewers conducted the full-text screening, appraised the quality of articles using an adaptation of the Joanna Briggs Institute’s appraisal tool (see Appendix), and performed the data extraction. Any disagreements regarding the eligibility, quality, and the scope of the articles were resolved through an iteration of discussions among the reviewers.Table 1 Eligibility criteria for the review
+
+Criteria items	Articles included	Articles excluded	
+Type of articles	Peer reviewed literature (i.e., qualitative, quantitative, mixed-methods analyses), peer-reviewed grey literature (e.g., Working papers)	Audio recordings, visuals/graphics, book chapters, review articles (systematic literature reviews, scoping reviews), editorials/commentaries/policy briefs/thesis or dissertation reports, simulations/modelling studies, abstracts only (e.g., conference abstracts)	
+Definition of transit	According to the International Organization for Migration [8]:
+
+Country of transit: In the migration context, the country through which a person or a group of persons pass on any journey to the country of destination or from the country of destination to the country of origin or the country of habitual residence
+
+Refugees in transit: Refugees who are temporarily admitted in the territory of a State under the condition that they are resettled in
+
+Posselt [28] defined “Transitional contexts” as those in which the participants did not possess legal residency status nor were they residing in host countries which offered a standard UNHCR resettlement programme
+
+	
+Year of publication	Articles only published between 2013 and 2024	Articles published before 2013	
+Study population and geographical restriction	Articles on adult refugee/asylum seeker/undocumented migrant women (above 18 + years of age) residing in ‘transit’ conditions
+
+Articles only from South Asia and Southeast Asia (list of countries: Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, Afghanistan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam)
+
+	Articles on refugees or asylum seekers residing in host countries with legal status
+
+Articles not from South Asia or Southeast Asia
+
+Articles in which refugees made up less than 25% of the study population
+
+Studies on children/youth or women below 18 years of age
+
+	
+Language restriction	Literature available in English	Literature published in other languages	
+Outcome measures	Health area focus related to the following: infectious diseases or communicable diseases, physical injury or wounds, psychological symptoms and mental health, Non-communicable diseases or chronic diseases, sexual and reproductive health and rights, maternal health and pregnancy, sexual and gender-based violence and violence against women
+
+Health behaviours (health seeking, health promoting, healthcare utilization)
+
+Healthcare access (quality, access, acceptability, affordability, availability)
+
+Health knowledge/awareness
+
+	Analyses on disease profile or epidemiology only
+
+Analyses on molecular/genetic analyses
+
+Analyses on health care providers’ perceptions only
+
+	
+
+Data Analysis
+
+This review employed a narrative synthesis approach, which involved the identification and grouping of themes related to health outcomes and healthcare access. In addition to these primary themes, the analysis also highlighted intersectional perspectives, including gender perspectives that may influence the health and healthcare access of transit refugee women.
+
+Results
+
+This review, using a narrative analysis, aimed to scope the existing evidence on the health outcomes, healthcare access, and experiences of refugee women in transit across South Asia and Southeast Asia. From the initial set of 1486 records, a total of 14 articles were identified for inclusion following the full-text screening (see Fig. 1). Table 2 summarises the key findings from the review (see Appendix).Fig. 1 Identification, screening and the inclusion of articles in the review
+
+A majority of the articles captured insights from transit refugee women living in Bangladesh [26–30], Thailand [34–41], and Malaysia [42]. Transit refugee women captured in this review originated only from Myanmar, with Rohingya and Karen being the main ethnic groups. All studies from Bangladesh focused exclusively on the Rohingya population temporarily residing in Kutupalong refugee camp, the closest part of Bangladesh to Rakhine State in Myanmar. Meanwhile, most studies from Thailand assessed a mix of ethnic groups such as Chin and Karen communities who fled Southern Myanmar and were living in transit at the Mae La refugee camp in Thailand, along with groups who held different legal statuses such as asylum seekers and migrants. Lastly, the study from Malaysia observed Rohingya refugees in transit who live in urban areas and are often referred to as urban refugees because they live among the local communities instead of a camp.
+
+Of the included articles, two were qualitative studies, eight were quantitative studies, and four utilized mixed-methods approaches. The majority of articles gathered primary data by recruiting participants from the community settings or clinics that serve the refugee camps, whereas two studies conducted retrospective analyses of records from clinics or non-governmental organizations (NGOs) working with refugees in transit [30, 41].
+
+Health Outcomes
+
+A majority of the articles [27, 29–38] reported on SRHR, including three studies on family planning and contraceptive use [30, 33, 41], one on HIV [29], and two in maternal and neonatal health [32, 40]. Meanwhile, four studies focused on mental health [32–35] and two studies [39, 42] focused on SGBV. Three studies [31, 33, 42] captured a combination of SRHR outcomes, consisting of family planning, STIs, menstrual health and hygiene, maternal health, and SGBV.
+
+In regards to family planning and contraceptive use, Khan et al. [30] reported in a study from Bangladesh that contraceptive injections were the most commonly used type of contraceptive, followed by the oral contraceptive pill, and implants and sterilization were used the least. Additionally, a study from the Thai-Myanmar border [41] reported an increase in contraceptive use between 2002 and 2015, which was associated with new contraceptive consultations. This also resulted in reduced rates of pregnancy during this period.
+
+Fellmeth et al. [35–38] reported that perinatal mental health symptoms included intense sadness, anger and fear, excessive worry, depression, and suicidal ideation, some of which were associated with factors such as employment and income insecurity, lack of family and social support, and having experiences of trauma and violence. Refugees were more likely to experience suicidal ideation, even though they are at a lower risk of experiencing depression, compared to migrants [38]. Additionally, unplanned pregnancy also increased the experiences of suicidal ideation among women [40].
+
+Rajaratnam et al. [42] reported that SGBV manifests in the form of marital rape, domestic violence, child rape and sexual assaults, with reported perpetrators included their spouses, community members, locals, employers and teachers. SGBV was highlighted as a barrier to healthcare utilization, as a factor that heightened the risk of moderate to severe perinatal depression, and increased the odds of pregnancy complications such as vaginal bleeding and severe abdominal pain [39].
+
+Facilitators and Barriers to Healthcare Knowledge and Utilization
+
+The analysis highlighted several factors that facilitated and barricaded access to healthcare, including the availability of healthcare services, healthcare financing and resources, and health knowledge transmission. These factors positively and negatively influenced preventative health behaviours, health-seeking and healthcare utilization behaviours related to several health outcomes such as antenatal care, HIV transmission, family planning, and contraceptive use.
+
+Six articles [29–34] highlighted that distance to healthcare facilities and the availability of healthcare facilities and services improved health knowledge, health-seeking and healthcare utilization behaviours related to antenatal care, family planning, contraceptive use, and HIV transmission. In Cox’s Bazar, Bangladesh, the availability of healthcare facilities within the residential block increased the odds of having better HIV knowledge by twofold and the use of contraceptives by almost fourfold among transit refugee women [29, 30].
+
+Additionally, having regular interaction with healthcare providers, including community health workers and health volunteers, was noted in five studies as a facilitating factor for healthcare utilization and knowledge [27–31, 36]. Various forms of interaction included consultations regarding SRHR [31–33], door-to-door visits [30, 31], participating in interventions such as family planning, counselling and SRHR awareness programs at the camp [28, 30], regular visits to health clinics [33], including antenatal care (ANC) visits, and prior utilization of family planning services [34]. These facilitating factors resulted in increased utilization of ANC that corresponds with reduced low birthweight prevalence, with one study highlighting that the number of ANC visits served as a protective factor against low birthweight delivery [34].
+
+Regular interaction with health professionals through door-to-door visitations and home visits, and having a reliable source of knowledge were associated with improved health awareness, and contraceptive use and contributed to having better awareness and perception towards SRHR interventions [31]. However, three studies [31–33] highlighted that cultural attitudes and social stigma—such as norms discouraging open discussion of sexual and reproductive health, and beliefs that contraception use is morally inappropriate or contrary to religious values—within communities and by health professionals, were associated with poor sexual and reproductive health outcomes, such as reduced contraceptive usage and family planning utilization.
+
+Religious and cultural beliefs were highlighted as a barrier in five studies [29–33], such as that men and women were prohibited from interacting and sharing the same space in ambulances and hospitals [29]. This impacted women’s menstrual health and hygiene practices, as well as maternal health outcomes, including birthing at health facilities. Rohingya women also believed that using contraceptives was a religious sin, resulting in the disuse of contraceptives and family planning. Additionally, the belief that having more children, particularly male children, brought financial solvency and security as they age, also reduced family planning and contraceptive usage [33]. Additionally, three studies [29, 32, 33] reported that poor health knowledge, health misinformation and misperceptions (e.g., probable side effects of contraceptives) attributed to women’s refusal to use contraceptives.
+
+The employment status of women and mobility outside their shelter were facilitating factors for seeking healthcare [29, 30, 33]. Women who were employed had higher odds of exhibiting good knowledge of HIV and displayed higher use of contraceptives [29, 30]. Other demographic characteristics such as age when first married, having a higher education level, the employment status of their spouse, and the absence of non-consensual sex, were facilitators for positive SRHR outcomes.
+
+Three studies [35–37] highlighted that a lack of social support networks within their neighbourhoods, having poor telephone networks, and poor road and physical infrastructure, collectively, was associated with delayed and reduced health-seeking behaviours, healthcare utilization, and were perceived by refugee women as a cause of poor mental health, including perinatal depression. Additionally, administrative and legal issues, alongside financial constraints that include incurring high out-of-pocket expenditure for accessing hospital services for refugee women living in urban settings, hindered healthcare access, increased health-seeking dropout rates, and poor mental health [35, 42]. One study reported that women relied on their husbands, who engaged in underpaid informal work, to afford their medical expenses. Contrary to this, having the UNHCR card and being connected to local NGOs reduced the fear of being arrested and/or detained and receiving healthcare and treatment without incurring out-of-pocket payments [42].
+
+Gendered Perspectives
+
+Several studies also highlighted important gendered perspectives, which positively or negatively influenced healthcare access, health-seeking and utilization behaviours, and their health outcomes. Two studies [30, 33] reported that requiring spousal consent for health-seeking or husbands’ disapproval of contraceptives resulted in foregoing healthcare related to pregnancy care, STI checks, and contraceptive usage. Additionally, women’s financial dependence on their male family members and spouses influenced their healthcare decision-making regarding health-seeking and treatment [42].
+
+The lack of their spouses’ involvement in child rearing contributed to women’s poor mental health as mothers often felt alone and overwhelmed. Strict gender norms such as veiling practices among Rohingya women were associated with the strong tendency for home deliveries and the reluctance to give birth at health facilities, especially given that health transport vehicles and facilities were primarily designed for mixed-sex use. Contrary to this, Barua et al. [32] highlighted that the recruitment of Rohingya and Bengali women as community health workers, compared to having male community health workers, increased health communication, reduced language barriers, and increased health-seeking behaviours related to pregnancy care.
+
+Discussion
+
+This review aimed to scope the current evidence regarding the health and healthcare access of transit refugee women across South and Southeast Asia. The findings drew insights on the health outcomes, alongside the facilitators and barriers to healthcare access, health-seeking and healthcare utilization and knowledge of mainly the Rohingya communities residing in Bangladesh, Karen communities in Malaysia, and Chin communities residing Thailand. Given that South and Southeast Asia are regular migratory routes, our findings indicate that there is a dearth of evidence concerning transit refugees’ health and access to healthcare. Therefore, more evidence is needed to understand the needs, challenges, determinants, and experiences of transit refugee women to address and improve the health and health equity for these subgroup populations. Our findings also shed light on how gender perspectives influence the health and healthcare access of transit refugee women within these transit contexts. These perspectives provide important insights on both the need and ways to better integrate targeted gender-responsive strategies to improve the health and healthcare access for women refugees in transit.
+
+The findings from this review revealed that transit women faced significant challenges, primarily related to their sexual and reproductive health and rights (SRHR), including contraceptive usage, family planning, STI and HIV prevention and control, as well as pregnancy and neonatal care. In addition, these women experienced poor psychological and mental health and were vulnerable to SGBV. SRHR emerged as a central theme in the review, as the majority of the studies focused on maternal and reproductive-aged women. In line with our findings, studies from other regions, including Sub-Saharan Africa, Europe and the Mediterranean have identified sexual and reproductive health as a central focus, with migration and displacement interrupting access to family planning, and sexual health and reproductive services and rights, placing women at greater risk of adverse health outcomes [43–45]. These findings therefore underscore the importance of prioritizing SHRH within the humanitarian crisis and refugee contexts, particularly in relation to women transit refugee populations.
+
+The findings revealed how several health-determining factors either hindered or facilitated healthcare access, health-seeking and utilization behaviours, and health knowledge transmission. Corroborating wider studies, these findings highlighted the significant influence of physical distance from healthcare facilities, the availability of services, financial constraints, and out-of-pocket healthcare expenditure [13]. Additionally, having access to humanitarian assistance programs, such as the UNHCR card, which allows refugees to access healthcare services, medicines, and treatments, played a critical role in shaping healthcare access and health-seeking behaviours. However, these health facilitating and hindering determinants are closely linked to transit conditions, such as whether refugees reside in camps or in urban areas along with the host community. For example, in Cox’s Bazar, Bangladesh, Rohingya populations are placed in designated transit refugee camps that provide health clinics and services, including community health workers who address the health needs within the camp setting [29–33]. In contrast, other migrant populations residing in urban areas are required to seek their own healthcare, often resulting in high out-of-pocket expenses [42]. This financial burden impacts the regularity and frequency of healthcare utilization, particularly for sexual and reproductive health and rights (SRHR) needs, such as contraceptive use, family planning, STI control and HIV prevention, and maternal and neonatal care.
+
+Religious beliefs, socio-cultural practices, and prescribed gender norms further compound the barriers to healthcare access and utilization [7]. For instance, among Rohingya communities, women’s veiling practices, prohibitions against opposite-sex interactions, stigmatization of reproductive health issues —including family planning and contraceptive use—and requirements for spousal consent for healthcare access are significant obstacles for transit women to seek treatment [30, 32, 33]. These barriers limit access to essential SRHR services and increase women’s susceptibility to sexual and gender-based violence and poor mental health outcomes.
+
+Study Limitations
+
+We acknowledge two significant limitations in this study. First, due to the absence of a universal classification for identifying this transient subgroup, their refugee status is often poorly defined, especially in countries that serve as established transit hubs and offer provisions such as designated refugee camps. As a result, they may be categorized under refugee or asylum seeker status, which does not accurately reflect their situation as transit refugees. With this view, in some studies that included a mixed study population including non-refugees, a minimum of 25% threshold was applied to filter articles to ensure enough representation of refugees’ health outcomes [35–38]. Although these articles provide valuable insights into the healthcare access challenges faced by transit refugee women, the lack of clear definitions regarding their status may have limited our ability to draw stronger conclusions about transit women’s health inequities. Second, the search was limited to English-language articles. This restriction may have led to the exclusion of studies offering country-specific perspectives and experiences, potentially overlooking important nuances related to the gender perspectives that intersect with migration, transit refugee status, and health inequities.
+
+As the population of transit refugees continues to grow globally, there is an urgent need for future research and policy action to address intersectional health challenges faced by transit refugee women, particularly across South and Southeast Asia. To address these challenges, health interventions targeting transit refugee women’s health issues must adopt context-specific and gender-responsive approaches that provide accessible, culturally sensitive, and comprehensive healthcare services [46]. Evaluations of health programs from Cox’s Bazar in Bangladesh that are designed to integrate more culturally appropriate and gender-responsive approaches, such as providing counselling and contraceptive consultations, along with the recruitment of women, including Rohingya women, as health volunteers and midwives, were found to significantly improves HIV control, increase contraceptive usage, improve family planning practices, ANC, safe abortion practices, and increase rates of facility-based deliveries compared to births occurring in shelters. Additionally, health programs that have engaged with spouses and male community members, including religious leaders, have improved women’s health-seeking, particularly in relation to their sexual and reproductive health, reduced incidence and risks of SGBV and child marriage outcomes [47].
+
+Conclusion
+
+This scoping review highlights the significant health outcomes and issues related to healthcare access and health-seeking and utilization, faced by refugee women in transit across South and Southeast Asia, which are common migratory routes from countries of origin to host nations. Barriers such as distance and availability of healthcare services, high healthcare costs, stigmatization, alongside religious and gender-based restrictions, often result in delayed or foregone care, particularly for women’s sexual and reproductive health. These challenges are further compounded by poor mental health and heightened vulnerability to sexual and gender-based violence. Targeted interventions such as the provision of the UNHCR humanitarian cards, and gender-responsive approaches such as the recruitment of women healthcare workers, and the establishment of sex-specific health facilities, are shown to improve healthcare access and improve health outcomes. This review sheds light on the limited evidence available regarding the health and healthcare access of transit refugee women, with a regional focus of South and Southeast Asia. The review underscores the critical need for more gender-responsive and targeted interventions to improve access to essential healthcare for transit women refugees living in precarious conditions across the region.
+
+Appendix 1
+
+See Table 2.
+
+Table 2 List of key words used in the review
+
+Key words [MeSH Terms]	Related words [MeSH Terms]	
+Transit refugee	refugees”[MeSH Terms] OR refugee [Text Word]
+
+· Refugee in transit, transit refugees (undocumented migrant, illegal immigrant, displaced persons, internally displaced person)
+
+	
+Healthcare access	Health Services Accessibility, Healthcare Access, Access to Care, Health Equity, Healthcare Disparities, Barriers to Healthcare, Health Service Availability, Geographic Accessibility, Financial Accessibility, Healthcare Affordability, Health Insurance Coverage, Primary Care Access, Rural Health Services, Urban Health Disparities
+
+· Health behaviours (including, health-seeking, health-preventative behaviour, health-promoting behaviour, healthcare utilization)
+
+	
+Health outcomes	Mental health (stress, depression, PTSD)
+
+Psychological wellbeing markers (e.g., suicidal ideation), Sexual and reproductive health and rights (including, family planning, contraceptive use, pregnancy, abortion, menopause menstrual health and hygiene)
+
+Food insecurity (or hunger, food scarcity) and Malnutrition (or Malnourishment, Undernutrition, Nutritional Deficiency, Nutritional Deficiencies)
+
+· Sexual and gender-based violence (domestic violence, intimate partner violence, violence against women)
+
+	
+Geography/countries	South Asian and Southeast Asian region (list of countries: Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, Sri Lanka, Afghanistan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam)	
+Example Search: (((transit refugee) AND (women)) AND (health)) AND (southeast asia):
+
+(“transit”[All Fields] OR “transited”[All Fields] OR “transiting”[All Fields] OR “transition”[All Fields] OR “transitional”[All Fields] OR “transitionals”[All Fields] OR “transitioned”[All Fields] OR “transitioning”[All Fields] OR “transitions”[All Fields] OR “transits”[All Fields]) AND (“refugee s”[All Fields] OR “refugees”[MeSH Terms] OR “refugees”[All Fields] OR “refugee”[All Fields]) AND (“womans”[All Fields] OR “women”[MeSH Terms] OR “women”[All Fields] OR “woman”[All Fields] OR “women s”[All Fields] OR “womens”[All Fields]) AND (“health”[MeSH Terms] OR “health”[All Fields] OR “health s”[All Fields] OR “healthful”[All Fields] OR “healthfulness”[All Fields] OR “healths”[All Fields]) AND (“asia, southern”[MeSH Terms] OR (“asia”[All Fields] AND “southern”[All Fields]) OR “southern asia”[All Fields] OR (“south”[All Fields] AND “asia”[All Fields]) OR “south asia”[All Fields]).
+
+Some keywords did not have corresponding MeSH terms. Therefore, these keywords were searched as free-text terms to ensure comprehensive coverage
+
+Appendix 2
+
+See Table 3.
+
+Table 3 Quality appraisal of studies included in the review
+
+Checklist items	Study 1	Study 2	Study 3	Study 4	Study 5	Study 6	Study 7	Study 8	Study 9	Study 10	Study 11	Study 12	Study 13	Study 14	
+Clear inclusion criteria	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	
+Description of study subjects and setting	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	
+Valid and reliable exposure measurement	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	
+Use of measurement criteria	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	
+Identification of confounding factors	✓	✓	✓	✓	✓	Na	✓	Na	✓	✓	✓	✓	✓	✓	
+Stated strategies for confounding factors	✓	✓	✓	✓	✓	Na	✓	Na	✓	✓	✓	✓	✓	✓	
+Valid and reliable outcomes measurement	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	✓	
+Use of proper statistical analysis	✓	✓	✓	✓ Mixed-methods analysis	✓	Qualitative analysis	✓	Qualitative analysis	✓	✓	✓	✓	✓	✓	
+Overall risk rating and inclusion	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	Low risk & included	
+
+Appendix 3
+
+See Table 4.
+
+Table 4 Summary of articles included in the review
+
+Author (Year)	Country (Region)	Sample population	Study design	Area of health focus	Key outcomes	Notes (e.g., intersectional perspectives)	
+Khan et al. [30]	Bangladesh (South Asia)	N = 508 Rohingya refugee women	Cross-sectional study	Health knowledge about HIV	Knowledge about HIV transmission increased with age at which they were first married, with having formal education, with engaging in work outside their households, and among those whose husbands were employed
+
+Knowledge about HIV transmission was associated and increased with the availability of healthcare services where women resided
+
+HIV transmission and prevention influenced by (reduced) mobility, cultural and religious restrictions/customs regarding access to reproductive healthcare
+
+		
+Khan et al. [30]	Bangladesh (South Asia)	N = 493 (Rohingya refugee women, included women who were married or given birth 2 years prior to the survey)	Cross-sectional study	Family planning and access to contraceptives	Over half of the sample were using contraceptives at the time of the study, with the largest proportion reportedly using contraceptive injection, followed by oral contraceptive pill, an implant, and undergone sterilization
+
+Reasons for not using contraceptives: disapproval by women’s husbands, desiring pregnancy, and religious beliefs/restrictions
+
+Only 10.95% of the sampled women received frequent and recommended home visits (every 2 weeks) by a healthcare worker, and those who received these visits received both family planning and provision of contraceptives
+
+Use of contraceptives were higher among those who reported no non-consensual sex with their husband in the year before, compared with occasional or frequent non-consensual sex, among those who resided in a camp with a mobile healthcare centre, compared with women whose camp did not have health facilities
+
+Women’s employment outside their household and the existence of a healthcare centre within the camp was positively associated with the use of contraceptives
+
+Women whose recent pregnancy was unplanned and lower age at first marriage was negatively associated with the use of contraceptives
+
+		
+Zakaria et al. [31]	Bangladesh (South Asia)	N = 415 (Rohingya women from Cox’s Bazar refugee camp, Bangladesh, included women were of reproductive aged (18–49 years)	Cross-sectional study	Knowledge about SRH related to: STIs, family planning, menstrual health and hygiene, maternal health	SRH awareness was associated with:
+
+The current number children (having fewer children were associated with better SRH outcomes)
+
+Having a reliable source of SRH knowledge
+
+Having access to SRH and MH care
+
+Ever had consulted a doctor/nurse on SRH
+
+Ever had a door-visit by a NGO worker on SRH
+
+Participated in a SRH awareness program
+
+Barriers to SRH awareness and healthcare:
+
+Language barrier between doctors working in the refugee camps
+
+Religious prohibitions and beliefs
+
+Cultural and traditional practices/beliefs (e.g., not cooking or engaging in domestic chores during menstruation)
+
+	The recruitment of Rohingya and Bengali women as community health workers increased health communication and reduced language barriers
+
+Working with Imam (Muslim religious leader) and Majhi (local Rohingya leaders) helped to disseminate health information and messages, including at Mosque and religious institutions
+
+	
+Barua et al. [32]	Bangladesh (South Asia)	1st phase (N = 100 Rohingya refugee women who used services)
+
+2nd phase (n = 33, of which 12 were Rohingya refugee women) who used services
+
+	Mixed-methods study	Maternal health, including emergency obstetric services	Enablers to healthcare access:
+
+Knowledge about the presence of referral hubs, having counselling services, and having transportation to the hubs improved maternal health indicators
+
+Sources of knowledge including community health volunteers, followed by neighbours, and community leaders (Majhi) improved maternal health indicators
+
+Barriers to healthcare:
+
+Mis or poor knowledge about the transport option reduced health-seeking and utilization behaviours
+
+Cultural and gender norms—women are not allowed to speak with male health workers
+
+Poor telephone network reduced health-seeking and utilization behaviours
+
+Poor roads and infrastructure delayed timely healthcare and increased physical and psychological distress among women
+
+	Due to strict gender norms and veiling practices among Rohingya women, there is a strong tendency for home deliveries and reluctance to give birth at health facilities (due to mixed-sex health vehicles and spaces within the facilities)
+
+Male community health workers cannot interact with Rohingya women due to cultural and gender norms, and Rohingya women tend not to use the transportation vehicles during pregnancy related care due to male drivers
+
+	
+Azad et al. [33]	Bangladesh (South Asia)	N = 400 Rohingya women (18–49 years) who had lived with their husbands and delivered at least one child at least 1 year before the study	Cross-sectional study	Family planning and contraceptive usage	Reasons for not using family planning and contraceptives:
+
+Husband’s disapproval
+
+Desire to get pregnant
+
+Religious/cultural belief that using contraceptives was committing a sin
+
+Being worried about probable side effects of contraceptives
+
+Belief that more children brought financial solvency to the family
+
+Belief that bearing children until a male child is born, agreeing that having more sons would ensure security for elderly parents
+
+Perception that contraceptive usage reduced pleasure of sexual intercourse
+
+Factors contributing to family planning and contraceptive use
+
+Women being employed (having a profession), and having less children
+
+Having a physician/nurse as a source of family planning knowledge
+
+Having and participating in family planning interventions at the camp
+
+Regular visitations to the clinic/health facility and discussing SRH issues with a healthcare provider
+
+		
+Rajaratnam and Aznam [42]	Malaysia (Southeast Asia)	N = 22 Rohingya women, N = 11 key informants (medical social workers, medical officers, volunteer workers, refugee officers and a mental health provider)	Qualitative study	Sexual Gender-based violence, mental health	Factors leading to healthcare access:
+
+Having a UNHCR card helped to reduce the fear of being arrested and detained
+
+Having a UNHCR card helped to receive treatment, and avoid high out-of-pocket payments for treatment and healthcare
+
+Having a connection with any NGOs or local Malaysian individuals to pay their medical bills lead to better access to hospital and healthcare
+
+Barriers to healthcare access:
+
+Administrative issues (e.g., long waiting queues for UNHCR card registration) posed significant challenges in relation to admission and treatment in (public) hospitals
+
+High out-of-pocket expenditure for hospital treatment (e.g., surgical procedures), childbirth, and buying medicines
+
+Stigma and threats from health professionals in relation to payment of medical expenses
+
+High payment charges for consultations and medicines, and regular visitations increased drop-out rates and mental illness
+
+	Common form of SGBV were marital rape, domestic violence, child rape and sexual assaults (perpetrators included their husbands, community members, locals, employers and teachers)
+
+Women and girls engaged in unpaid domestic work and depended on their male family members and husbands for money to afford medical expenses
+
+Social support from other women and family/friends relieved psychological distress and mental health outcomes
+
+	
+Perera et al. [34]	Thailand-Myanmar border	N = 34,240 women who had a delivery between 2008 to 2019	Retrospective study (2008–2019)	Family planning and maternal health	Low birth weight deliveries were associated with fewer first and second trimester ANC visits, compared with normal birth weight deliveries
+
+The number of first and second trimester ANC visits and prior utilization of family planning services were protective factors against low birthweight deliveries
+
+Mothers who delivered low birthweight infants were likely to have lower utilization rate of family planning services
+
+Low birthweight deliveries were significantly associated with mothers age likely to be under 20 years of age
+
+		
+Fellmeth et al. [35]	Thailand-Myanmar border	N = 116 (29 pregnant refugees, 63 pregnant migrants, 24 antenatal clinic staff)	Qualitative study	Perinatal mental health	Symptoms and behaviours related to mental illness among women included, intense sadness, anger and fear, excessive worry, and physical symptoms (i.e., headaches, loss of appetite, poor or excessive sleep, heart palpitations, and having cold hands and feet
+
+Causes of perinatal mental illness included lack of employment and low income, lack of family support (i.e., unsupportive partners, parents, and family members) and worry about children
+
+Suicide was not perceived as not being attributed to mental illness. The causes of suicide included: shame, guilt, economic and family issues, spirituality
+
+		
+Fellmeth et al. [36]	Thailand-Myanmar border	N = 568 women (317 labour migrants and 250 refugees)	Mixed method cohort study	Perinatal mental health	Psychosocial factors such as interpersonal violence, a history of trauma, a self-reported history of depression, perceived insufficiency of social support, and labour migrant status were the main risk factors for moderate/severe perinatal depression
+
+Depression of any severity, including moderate/severe depression was higher among refugees compared to labour migrants
+
+At one month postpartum, women who experienced any depression during the first trimester are more likely to still be depressed, while those who had moderate-severe depression have generally begun to recover
+
+Antenatal and postnatal depression were significantly associated, emphasizing the importance of early identification and intervention to avoid persistence of depression
+
+		
+Fellmeth et al. [37]	Thailand-Myanmar border	N = 451;
+
+233 (52%) pregnant migrants and 218 (48%) pregnant refugees;
+
+	Mixed method prospective cohort study	Perinatal mental health	The prevalence of perinatal depression was higher among refugees at 47.3%, compared to 38.6% among migrants
+
+Proportion of refugees who reported support from partners and sufficient support were lower than that of migrants, while refugees also exhibited lower received support scores than migrants
+
+Insufficient perceived support among refugees increased the odds of perinatal depression (AOR: 1.89)
+
+History of depression (AOR 3.35) and high trauma score (AOR 1.63) increased the risk of depression, while having a telephone halved the odds of depression
+
+		
+Fellmeth et al. [37]	Thailand-Myanmar border	N = 568;
+
+318 (56%) migrant and 250 (44%) refugees in refugee and migrants’ clinics
+
+	Mixed method prospective cohort study	Perinatal mental health	Prevalence of suicidal ideation during perinatal period was 5.3%, while subthreshold symptoms was identified in 23.8% participants
+
+Determinants of suicidal ideation includes household size, plan to return to Myanmar, interpersonal violence, history of depression, and social support
+
+Trauma score (aOR 2.32) and unplanned pregnancy (aOR 2.74) increased the odds of suicidal ideation
+
+Women with suicidal ideation were 24 times more likely than women without suicidal ideation to have a diagnosis of depression
+
+Refugees were more likely to experience suicidal ideation than migrants
+
+		
+Prins et al. [40]	Thailand-Myanmar border	N = 522	Cross sectional study	Maternal and child health	Knowledge: Most participants could recognize jaundice (92.5%) and knew that it was harmful (95%). Most also reported they would bring the baby to the clinic if jaundice was observed (96.2%). Most commonly cited source of knowledge was healthcare workers (65.9%)
+
+Practice: 41.4% of the pregnant women reported the use of mothballs, though only 18.2% used them to store baby clothes and blankets. Furthermore, 46.7% used menthol-containing products on baby skin
+
+Parous women who previously had a child with neonatal jaundice were more likely to identify the cause of jaundice, but did not exhibit safer behaviour such as reducing the use of mothballs and menthol which acts as haemolytic agent that increases the risk of jaundice in populations with a high prevalence of glucose-6-phosphate dehydrogenase deficiency,
+
+		
+Falb et al. [39]	Thailand	N = 377 women (reportedly had a partner/married and had most recent pregnancy that ended in a live birth within the last 2 years of the study)	Cross-sectional study	Gender-based violence and maternal health	Symptoms of pregnancy complications such as feeling very weak of tired, vaginal bleeding, severe abdominal pain, or blurred vision was found in:
+
+50% of women who experienced both conflict victimization and intimate partner violence (IPV) victimization
+
+One in three women who reported conflict victimization only
+
+one in five women who reported IPV victimization only
+
+One in three women who reported one type of victimization event
+
+The odds of experiencing pregnancy complication symptoms increased with reports of:
+
+Any type of violence (aOR 3.1)
+
+Conflict victimization, (aOR 3.0)
+
+History of abortion or stillbirth (aOR 1.6)
+
+	Health seeking behaviour was observed in 90% of women who reported symptoms of pregnancy complications in their last pregnancy that ended in a live birth	
+Srikanok et al. [41]	Thailand	N = 35.139 new family planning consultations	Retrospective study (1996–2015)	Family planning and contraceptive usage	In both TBBC and UNHCR population estimates, the number of new contraceptive consultations per 1000 reproductive age women from 2002 to 2015 increased
+
+The type of contraceptive most widely used were depo-injections, followed by pills which were trending up, and condoms which were trending down
+
+The use of IUD and implant increased by up to 8 × and 4 × respectively, along with upward trends in female sterilization uptake that surpassed LARC after 2004
+
+Pregnancy rate is showing a downward trend, with its lowest peak at 137 pregnancies per 1000 reproductive age women from 2009 to 2015
+
+Miscarriage rates remained relatively stable, with an apparent decrease in recent years
+
+		
+
+Abbreviations
+
+ANC Antenatal care
+
+FGM Female genital mutilation
+
+HIV Human immunodeficiency virus
+
+IOM International organization for migration
+
+SGBV Sexual and gender-based violence
+
+SRHR Sexual and reproductive health and rights
+
+STIs Sexually transmitted infections
+
+UHC Universal health coverage
+
+UNHCR United Nations high commissioner for refugees
+
+WHO World health organization
+
+Acknowledgements
+
+Not applicable.
+
+Author Contribution
+
+GF was involved in the conceptualization of the study, article screening, reviewing, the synthesis, drafting and finalizing the manuscript. AK was involved in the article screening, reviewing, the synthesis, drafting and finalizing the manuscript. SP, JW, and ADT were involved in the conceptualization of the study, article screening, reviewing and finalizing the manuscript. All authors contributed equally to the manuscript, and have read and approved the final manuscript.
+
+Funding
+
+Open Access funding enabled and organized by CAUL and its Member Institutions. This study was funded by Monash University, Indonesia.
+
+Data Availability
+
+No datasets were generated or analysed during the current study.
+
+Declarations
+
+Competing Interests
+
+The authors declare no competing interests.
+
+Ethical Approval
+
+Not applicable.
+
+Consent to Participate
+
+Not applicable.
+
+Consent for Publication
+
+Not applicable.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+46. Bouaddi O, Zbiri S, Belrhiti Z. Interventions to improve migrants’ access to sexual and reproductive health services: a scoping review - PubMed [Internet]. 2023 [cited 2025 Mar 7]. Available from: https://pubmed.ncbi.nlm.nih.gov/37311580/ 10.1136/bmjgh-2023-011981 PMC10277050 37311580
+47. Cheong D. UN Women – Asia-Pacific. 2022 [cited 2025 Mar 7]. Four Years On: Shifting Gendered Perceptions and Experiences. Available from: https://asiapacific.unwomen.org/en/digital-library/publications/2022/03/comprehensive-gender-analysis-within-rohingya-and-host-communities
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Palliat Care
+Journal ID: BMC Palliat Care
+NLM Journal ID: 101088685
+
+BMC Palliative Care
+
+EISSN: 1472-684X
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13123217
+PMID: 41851669
+DOI: 10.1186/s12904-026-02071-7
+Article ID: 2071
+Article version: 1
+Subjects: Research
+
+Palliative care in rural, remote, and northern communities: a scoping review
+
+Magyar Natasha 1
+Kortes-Miller Katherine 1 2
+Martin Lynn lynn.martin@lakeheadu.ca
+2 3
+1 https://ror.org/023p7mg82 grid.258900.6 0000 0001 0687 7127 School of Social Work, Lakehead University, 955 Oliver Road, Thunder Bay, ON P7B 5E1 Canada
+2 https://ror.org/023p7mg82 grid.258900.6 0000 0001 0687 7127 Centre for Education and Research on Aging and Health, Lakehead University, 955 Oliver Road, Thunder Bay, ON P7B 5E1 Canada
+3 https://ror.org/023p7mg82 grid.258900.6 0000 0001 0687 7127 Department of Health Sciences, Lakehead University, 955 Oliver Road, Thunder Bay, ON P7B 5E1 Canada
+Electronic publication date: 2026 Mar 19
+Publication date: 2026
+Volume: 25
+Electronic Location ID: 117
+Received 2024 Nov 30; Accepted 2026 Mar 16
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Palliative, End-of-Life, Rural, Remote, Northern, Life-limiting disease, Barriers, Facilitators
+
+Funding: http://dx.doi.org/10.13039/501100000008 Health Canada
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Objective
+
+To review and analyze existing literature on palliative care in rural, remote, and Northern communities and consider the gaps that remain in research in order to guide the direction of the current project.
+
+Introduction
+
+Like other areas of healthcare, persons living in rural, remote, and Northern regions face unique barriers when accessing palliative care in their communities.
+
+This scoping review provides an analysis of the current literature addressing palliative care in rural, remote and Northern regions globally and identifies themes in existing literature to determine areas of need for future research.
+
+Method
+
+Primary studies published in English in peer-reviewed journals between January 1, 2010 and February 2024 were identified CINAHL, ProQuest, PubMed, and OMNI.
+
+Results
+
+A total of 53 studies were eligible for data extraction. The existing literature identifies several common barriers and facilitators to accessing palliative care. Identified barriers include travel and cost of accessing care, policy issues, lack of communication, lack of knowledge/education. On the other hand, the identified facilitators include collaboration, advanced care planning, specialized education and training of care partners, utilization of telemedicine, and the use of volunteers.
+
+Conclusion
+
+Suggestions for addressing barriers and leveraging facilitators to palliative care in rural, remote, and northern locations throughout Canada were presented. Future research should build upon this knowledge to guide positive changes towards the shared goal of equitable access to palliative care for all Canadians, regardless of where they live.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12904-026-02071-7.
+
+Introduction
+
+A palliative approach to care is one that meets the needs of people with serious or life-limiting illness and their family in a practical and holistic way (e.g., symptom and pain management; social, emotional, spiritual, psychological support; practical support) and begins as early as possible in the disease process [1]. The demand for palliative care is expected to increase worldwide as the age of our population and the prevalence of chronic disease continue to rise. In 2018, the Canadian government introduced the Framework on Palliative Care [1] that outlines a standard of care and provides a guideline for palliative care stakeholders to work toward. In Health Canada’s five-year progress report [2], key areas where continued efforts are needed were noted, including increased capacity and improved access to palliative care in rural, remote, and Northern regions.
+
+Persons living in rural, remote, and Northern regions face unique barriers when accessing palliative care [3, 4]. Rural populations tend to be older and more likely to live with chronic illnesses, yet remain less likely to have access to timely, specialized palliative care [5, 6]. Due to limitations regarding staff shortages, education and training, and resources, implementation of comprehensive palliative care programs in rural, remote, and Northern areas is challenging [7, 8]. To improve access and help facilitate building community capacity, further research is needed in relation to palliative care needs in these communities.
+
+This scoping review aims to identify current knowledge of palliative care in rural, remote, and Northern communities to understand current issues facing persons, families, providers, and palliative care and health systems. It will identify themes in existing literature and identify gaps in knowledge that warrant further research.
+
+Methods
+
+This scoping review followed Arksey and O’Malley’s [9] five stage approach: (1) identify the research question, (2) identify relevant studies, (3) select studies for data extraction, (4) extract and chart data, (5) summarize and report results and the Preferred Reporting Items for Systematic reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR) critera. The study protocol has not been published.
+
+Eligibility criteria
+
+Our search strategy was developed in consultation with a librarian. Peer-reviewed primary studies published in English between January 2010 and February 2024 were eligible for inclusion. Reviews (narrative, scoping, systematic) and expert opinion pieces were excluded.
+
+Information sources
+
+We performed advanced searches in CINAHL, ProQuest, PubMed, and OMNI using relevant terms and medical subject headings (MeSH).
+
+Search
+
+Keywords included palliative, end-of-life, end-stage, aid in dying, hospice, terminal care, and life-limiting illness were used with the Boolean phrase “OR” to ensure that as many terms used to describe palliative care were utilized. These terms were paired using “AND” with rural, remote, or Northern. For example, the CINAHL search focused on full text articles with keywords palliative OR end of life OR aid in dying OR hospice OR terminal OR end stage AND rural OR remote OR northern in the title; we also excluded reviews (scoping reviews OR reports OR literature reviews) and articles focused on children (i.e., exclude pediatric).
+
+Selection of Sources of Evidence
+
+Participant
+
+We considered studies that reflected a variety of perspectives, for example, people with lived experience (PWLE) (e.g., receiving palliative care in rural, remote, or northern regions), informal carers, healthcare professionals, as well as those based on secondary analysis of health records.
+
+Context
+
+The focus of the studies should be on palliative care in rural, remote, or northern regions, but there were no restrictions based on setting (e.g., inpatient hospital, palliative care program, hospice).
+
+Data charting
+
+We developed a data extraction tool using Excel. Following the initial review of titles and abstracts by the primary and last authors, the data extraction of included articles was conducted by the first author and two research assistants; the last author reviewed five extractions from each to ensure quality and consistency of extractions.
+
+Data items
+
+The following information was extracted from eligible articles: author, year, country, study aim, design, sample size, participant characteristics, terminology and definitions used related to palliative care and rurality, and results. We also noted authors’ study limitations and suggestions for future research, though this was not included in the extraction table.
+
+Synthesis of results
+
+The authors relied on thematic analysis to identify themes throughout the existing literature. Once codes (labels) were determined, they were used to identify patterns, categories and themes across the literature. The codes were established by the first author and reviewed by both co-authors.
+
+Findings
+
+Selection of sources of evidence
+
+After removal of duplicates, a total of 320 articles were identified. Following review of titles and abstracts, 63 articles remained eligible for full review and data extraction. After full review, ten studies were eliminated for lack of explicit focus on palliative care services, leaving 53 studies (Fig. 1).
+
+Fig. 1 Flow chart of scoping review results
+
+Characteristics of sources of evidence
+
+This section describes study characteristics based on the data extraction (Table 1).
+
+Table 1 Key ites from data exntrmactio
+
+References	Country	Study design	Participants	Sample size	Participant characteristics	Term used	Findings - Themes	Findings - Subthemes		
+[10]	Miller et al. (2021)	Australia	Qualitative	Informal carers	9	Sex	PC, EOL	Barriers	Travel/Expense	
+[11]	Wilkinson et al. (2015)	Australia	Qualitative	Records: Informal carers	223 pre; 192 post	Age, Sex	PC, terminal care	Facilitators	 Education & Training	
+[12]	Carey et al. (2017)	Australia	Quantitative	Records: financial records, admission records	17	Age, Sex, Aboriginal and Torres Strait Islander status	PC	Facilitators	Community Based Care	
+[13]	Chukwusa et al. (2019)	United Kingdom	Quantitative	Records: deceased patient records (drive time to care)	430,467 (deaths)	Age	PC, EOL	Barriers	Travel/Expense	
+[14]	Pesut et al. (2010)	Canada	Mixed methods	PWLE	15	Age, Sex	PC	Barriers 	Travel/Expense	
+[15]	Wilson et al. (2012)	Canada	Mixed methods	PWLE	Phase 1: 17,798; Phase 2: 108; Phase 3: 11	Age, Sex, Employment status, Relationship	EOL	Barriers	Travel/Expense	
+[16]	Leng et al. (2019)	China	Quantitative	Informal carers	792	Geographic place of residence, socio-economic background, marital status, age, sex, treatment decisions, healthcare utilization, healthcare costs, money borrowed/owed for care	EOL, hospice	Other: Cost analysisIdentified barriers and facilitators within analysis	Age/Socioeconomic background/location and age	
+[17]	Dongre et al. (2012)	India	Quantitative	PWLE	900	Age, Sex, Education, Religion, Occupation, Socioeconomic status, Marital status, Family type	PC	Facilitators 	Education & TrainingCommunity Based Care	
+[18]	Howell et al. (2011)	Canada	Mixed methods	PWLE	95	Age, Sex, Marital status, Income	PC	Facilitators	Collaboration	
+[19]	Berke et al. (2023)	USA	Quantitative	HCPs	158	Age, Race, Profession	PC	Facilitators	Education & training	
+[20]	Del Rosario et al. (2019)	USA	Quantitative	Records: Veterans’ AffairsPWLE	66,958	Age, Sex, Race	EOL	Facilitators/Barriers 	Identifies access, attitudes/values, rurality as potential barriers/facilitators for use of hospice care 	
+[21]	Jones (2021)	USA	Quantitative	Records: Admission records and satisfaction scoresPWLE	1,175	Ethnicity	Hospice	Facilitator 	Spirituality/religious component to care	
+[22]	Ko et al. (2020)	USA	Qualitative	Informal carers	28	Age, Sex, Race, Relationship to person	Hospice	Barriers Facilitators	Communication; Knowledge ACP	
+[23]	Fletcher et al. (2016)	Australia	Qualitative	HCPs	55	Age, Sex, Occupation	Advanced care planning	Facilitators	ACP	
+[24]	Veillette et al. (2010)	Canada	Qualitative	HCPs, Healthcare administrators, Municipal leaders, Professionals	36	Age, employment status	Good death	FacilitatorsBarriers	Communication, Knowledge (ACP), CommunityTransportation, access to care	
+[25]	Lam et al. (2018)	Australia	Mixed methods	HCPs	109	Age, Sex	Advance care planning	Barriers Facilitators	Communication ACP	
+[26]	Odgers et al. (2018)	Australia	qualitative	PWLE	12	Sex	EOL	Barriers	Communication	
+[27]	Lomenick et al. (2021)	USA	Quantitative	Records: Administrative cost dataPWLE	6200 total patient days of care 	None specified	Hospice care	Facilitators	Telemedicine	
+[28]	Taylor et al. (2018)	United Kingdom	qualitative	HCPs, Researchers, Civil society organizations, Business partners	39	Not specified	Hospice Care	Facilitators	Telemedicine	
+[29]	Aregay et al. (2023a) 	Ethiopia	Qualitative	HCPs, Researchers	42	None specified	PC	Barriers	Policy issues	
+[30]	Herce et al. (2014)	Malawi	Mixed methods	Records & collected data PWLE & Stakeholders	47	Age, Sex	PC	Facilitators	Collaboration 	
+[31]	Koski et al. (2017)	Canada	Qualitative	HCPs, Community members	20	None specified	Palliative, Palliation	Facilitators	Collaboration, communication, knowledge translation 	
+[32]	Lalani & Cai (2022)	USA	Qualitative	HCPs	15	Age, Sex	Palliative, Palliation	Barriers Facilitators	Communication Education & training	
+[33]	Nadin et al. (2018)	Canada	Mixed methods	Records & collected dataPWLE	22	Not specified	PC	Facilitators 	Community Based Care 	
+[34]	Näppä et al. (2023)	Sweden	Qualitative	HCPs	10	Age, Sex	PC	Barriers	Communication, Training & education & Collaboration 	
+[35]	Prajitha et al. (2023)	India	Qualitative	HCPs		Not specified	PC	Barriers	Knowledge	
+[36]	Winter et al. (2020)	Canada	Mixed methods	PWLE	770	Sex	PC	 Barriers	Travel/Expense 	
+[37]	Bonsignore et al. (2018)	USA	Mixed methods	PWLE	101	Age, Sex	PC	Facilitators	Telemedicine	
+[38]	Koczwara et al. (2010)	Australia	Program development	HCPs	769	None specified	Palliative, Palliation	Facilitators	Education & training	
+[39]	Pesut et al. (2011)	Canada	qualitative	HCPs, PWLE, Families	95	Sex	PC	Barriers	Travel/Expense	
+[40]	Pesut et al. (2017)	Canada	mixed methods	PWLE	25	Age, Sex, Residence	PC, Palliative approach	Facilitators	Collaboration	
+[41]	Larson et al. (2021)	USA	Qualitative	Community Leaders	15	Age, Sex	PC, EOL	Barriers Facilitator 	Personal beliefsKnowledge  	
+[43]	Raziee et al. (2017)	Canada	Quantitative	Records: Administrative DataPWLE	17,649	Sex	Palliative, Palliation, EOL	Barriers	Rurality impacts place of death regardless of income level	
+[43]	Reed et al. (2018)	Australia	Mixed methods	HCPs	77	Sex	PC, EOL	Facilitators	Community Based Care	
+[45]	Jack et al. (2011)	Uganda	Qualitative	PWLE, HCPs, Volunteers	64	None specified	Hospice, PC	Facilitators	Volunteers	
+[44]	Crooks et al. (2018)	Canada	Mixed methods	HCPs, Informal carers	40	None specified	PC	Facilitators	Volunteers	
+[46]	Johns et al. (2019)	Australia	Qualitative	PWLE, Families, HCPs	38	Sex	Terminally ill, PC	Barriers	Policy issues; Knowledge	
+[47]	Johansen & Ervik (2022)	Norway	Qualitative	HCPs	52	Age, Sex	PC	Barriers	Communication	
+[48]	Munday et al. (2018)	India	Mixed methods	Hospital Administrators		Not clear	PC	Facilitators	Collaboration	
+[49]	Conlon et al. (2019)	Canada	Quantitative	Records: Linked health databasesPWLE	129,107	Age, Sex, Income quintile	PC	Barriers 	Community Based Care	
+[55]	Walter et al. (2018)	Germany	Quantitative	Records: Patient recordsPWLE	12,929 patients in initial groupSubgroup: 7707	Place of residences based on district type (rural, urban, remote, ect.), age, gender, diagnosis, treatment,	EOL, PC, Supportive care	Facilitators Barriers	GP Knowledge Access, travel	
+[50]	Crooks et al. (2010)	Canada	Qualitative	HCPs, Informal carers	31	None specified	PC	Barriers Facilitators	Policy issues Collaboration	
+[51]	Ding et al. (2019)	Australia	Qualitative	HCPs, Professionals	37	Age, Profession	PC	Barriers	Policy issues	
+[52]	McVeigh et al. (2019)	USA	Qualitative	HCPs	16	None specified	PC	Barriers	Communication	
+[53]	Aregay et al. (2023b)	Ethiopia	Qualitative	HCPs	38	None specified	PC	Barriers	Knowledge; Policy issues	
+[54]	McLouth et al. (2023)	USA	Quantitative	PWLE	77	Sex	PC	Barriers	Knowledge	
+[56]	Mitchell et al. (2016)	Australia	Mixed methods	PWLE	62	Age, Sex	PC	Facilitators	Collaboration (ACP)	
+[57]	Potts et al. (2019)	India	Qualitative	HCPs	10	Age, Sex	PC	Facilitators	Collaboration & Education	
+[58]	Watanabe et al. (2021)	Japan	Quantitative	Organizations	264	Not specified	PC	Facilitators	Collaboration	
+[59]	Duggleby et al. (2016)	Canada	Consensus (Delphi)	Researchers, Knowledge users, Stakeholders	30	None specified	PC, Advanced illness	Facilitators 	 Advocacy, collaboration, community-based care	
+[60]	Klinger et al (2012)	Canada	Quantitative	Records: Economic Records PWLE	95	Sex	EOL	Facilitators 	Collaboration 	
+[61]	Weng et al. (2022)	USA	Quantitative	Organizations	17	Not specified	PC	Facilitators 	Collaboration Training 	
+[62]	Ohta & Ryu (2021)	Japan	quantitative	PWLE	96	Sex		Facilitators	Telemedicine	
+PWLE Persons with Lived Experience
+
+HCP Health Care Provider
+
+PC Palliative care
+
+EOL End of life
+
+Country
+
+The majority of studies were conducted in Canada (n = 15), Australia (n = 11), the United States (n = 11). Studies from China (n = 1), Ethiopia (n = 2), Germany (n = 1), India (n = 4), Japan (n = 2), Malawi (n = 1), Norway (n = 1), Sweden (n = 1), Uganda (n = 1), and the United Kingdom (n = 2) were also identified.
+
+Study design
+
+Most studies employed qualitative methods (n = 23), which included interviews or observation. There were nineteen quantitative studies, many of which analyzed existing or retrospective data from healthcare and government databases. Thirteen studies employed mixed methods; one was based on a Delphi consensus building approach, and the other on program development10.
+
+Study samples and participants
+
+Study participants varied across the studies reviewed. Many focused on a single participant type (i.e., persons with lived experience (n = 11), health care professionals (n = 12), informal carers or family (n = 2), administrators (n = 1) and community stakeholders (n = 2), while some included multiple participant types that either did (n = 5) or did not (n = 8) include persons with lived experience. Three studies focused on organizational experiences, while one used geography to model communities in need of services.
+
+Overall, the majority had fewer than one hundred participants. Qualitative samples ranged between nine [10] and 223 [11], quantitative samples between seventeen [12] and 430,467 [13], and between fifteen [14] and 17,798 [15] for mixed methods studies.
+
+The reporting of participant demographics tended to be mixed. Only Leng and colleagues [16] provided extensive information on characteristics. A few studies presented information related to marital status [17, 18], race or ethnicity [12, 19–22], education [17], employment status or occupation [17, 19, 23, 24], socio-economic status [16–18, 25], and religion [17].
+
+Palliative terminology and definitions
+
+Several terms were used to describe target services. More than half referred to palliative care/approach and palliation, either exclusively (n = 31) or in conjunction with another term (n = 9). A few studies exclusively used other terms, including hospice or hospice care (n = 4), end-of-life care (n = 4), advance care planning (n = 2), and good death (n = 1). Overall, approximately half (n = 29) of the studies did not define the terminology used.
+
+The single study that employed the term “good death” provided multiple definitions, concepts, and theories - as its goal was to understand its meaning to individuals [24]. Advance care planning was defined by both studies that used it as a discussion focused on preferences, needs, and choices for the future [23, 25].
+
+Two of the four articles that referred to end-of-life care offered definitions. Odgers and colleagues [26] described it as a conversation that should happen about goals, preferences, and services at the end of life, whereas Del Rosario and colleagues [20] described the elements of high-quality end-of-life care, including pain management, recognition of the emotional and spiritual needs of the individual and family, and referral to specialist palliative or hospice care.
+
+Each of the four studies that exclusively used the term hospice or hospice care defined it. All but one study explicitly noted it is an interdisciplinary approach [21, 22, 27, 28]. Jones [21] further explained that it aims to help “patients cope with sadness and anxiety” (p185). Lomenick and colleagues [27] broadly referred to hospice care as provision of “quality end-of-life care for individuals facing life-limiting illness and/or injury” (p1461), while Ko and colleagues23 described it as a wide variety of services that included “pain and symptom management, bereavement services, psychosocial and spiritual care, for families and patients”. Taylor and colleagues [28] defined hospice care as providing “physical, social, emotional, and spiritual support for people with life-shortening illness”.
+
+Of the articles that relied solely on the terms palliative care/approach or palliation eight included that palliative care is an approach to care that addresses the physical, emotional, psychological, and spiritual well-being of a patient in their definition [29–36]. In addition, these same articles included that good palliative care aims to improve the quality of life for the patient and/or their family through meeting the patient’s needs.
+
+The remaining articles that relied on the term palliative care/approach or palliative differed slightly but shared some commonalities. Bonsignore and colleagues [37], Koczwara et al. [38], and Pesut et al. [39] define palliative care/approach as a type of care that manages symptoms of a chronic or life-limiting illness. Koczwara et al. [38] also included that this approach aims to assist patients and their caregivers in informed decision making alongside respecting the patient’s wishes regarding their care. Pesut and colleagues [40] also emphasize that a palliative care/approach honours the patient’s wishes as to the extent possible.
+
+Five articles used the terms palliative care and end of life care interchangeably [10, 13, 41–43], whereas one article relied on the term hospice in addition to palliative care [44]. Jack et al. [45] defines palliative/end of life/hospice care as an approach that occurs within the home. These authors attest in their definition that this type of care aims to improve patient quality of life by addressing their needs alongside relieving their symptoms.
+
+In their definition, Miller et al. [10] focused on unpaid carers and explicitly referred to provision of financial care as being important; this was not included in any other definition. Finally, Reed et al. [43] defined it as a specific time or state of one’s disease/illness progression and suggest that palliative/end of life care is the point at which the disease is considered to be terminal.
+
+Rural, remote, and northern definitions and measures
+
+More than half of the articles relied primarily on the term rural (n = 37), with the remainder using the terms remote and northern either in conjunction with the term rural or as another term used interchangeably with rural. Eighteen articles did not define the term or measure used to determine rurality, or remoteness of the location of study.
+
+The term rural was used in thirty-seven articles, and in conjunction with other terms in most remaining articles (n = 15). Thirty-three articles provided either a definition or measure for determining rurality. The term rural was primarily defined by population of a given area and measured by person per square kilometer or mile (n = 21). The remaining articles defined rurality by the distance from the nearest metropolitan area (n = 6), the distance to the nearest specialized care facility (n = 6), or a combination of these measures (n = 4). One article relied on the number of physicians in a geographical radius as the primary measure of rurality [32]. The term sparsely populated was also used interchangeably with rural. The threshold required to be defined as rural varied by location of study.
+
+The term remote was used in four articles, never exclusively. It was used most often to identify a location of study as “hard to access” or as more isolated when compared to other communities designated as rural. In three articles that relied on this term, it was defined by an already established geographical designation and mainly measured by severity of isolation [12, 44, 46], in the remaining article it was defined by population density and commuting time to an urban area [39]. All articles that used the term remote, relied on a measure set by a governing body in the location of study. The terms isolated, and hard to reach were used interchangeably or instead of remote, however the definition and measure of all three terms were relatively the same.
+
+The term northern was used in five articles to identify the geographic location and was always used in conjunction with either rural or remote [12, 41, 47–49]. While all articles that used the term northern appeared to rely on an establish national standard, only two articles provided a measurement or definition for the term, both of which explicitly stated that they were measured by a national standard or guideline in the jurisdiction of the study [48, 49].
+
+Synthesis of results
+
+The objective of this review was to identify the focus and findings of existing literature on palliative care in rural, remote, and Northern communities. Two major themes were identified across study topics: (1) barriers for accessing palliative care and (2) facilitators for improving access. The following section provides a brief overview of the analysis and sub-themes within both overarching themes.
+
+Barriers for accessing palliative care in rural, remote and northern areas
+
+Nineteen studies addressed barriers in accessing palliative care in rural, remote and northern areas. All recognized that lack of access to palliative services and providers was the primary cause of reduced utilization of palliative care for this population. The following barriers were also noted: travel and expense associated with accessing care outside the community [11,14,15,16,25,37,39.50], policy issues [29, 46, 50, 51], communication [22, 25, 26, 32, 34, 47, 52], and knowledge [22, 32, 35, 46, 53, 54].
+
+Travel and expense of accessing care outside the community
+
+Eight articles identified travel to access care outside the community and the associated costs as a barrier for accessing equitable palliative care. Pesut and colleagues [14] found that some people were forced to cut expenses such as groceries to afford the high cost of travel.
+
+A Canadian study and German study highlighted that in many rural communities, palliative services simply do not exist [15, 55]. When care is available, they found that it is scattered across many places (where care transitions varied from 8 to 39 per individual), which significantly increased travel.
+
+Chukwusa and colleagues [13] studied the drive time and place of death and found that, for those living in rural areas (compared urban areas) the distance between home and care center played a role in whether one dies at home, hospital, or in another type of care facility.
+
+Miller and colleagues [10] found that informal carers living in rural areas face stress due to traveling to access necessary care for their loved ones, in addition to feeling burnt out and isolated.
+
+Policy issues
+
+Four articles identified issues with policy as a primary barrier. According to two articles by Aregay and colleagues [29, 53], governments still hold low priority and focus on palliative care. Many governments have adopted palliative care frameworks but draw attention to their focus on the management of curable diseases rather than holistic care models, the absence of funding and other resources required to actualize necessary care, and lack of awareness of frameworks among leaders and professionals. Ding and colleagued [51] focused on fiscal politics of palliative care frameworks. More specifically, how inappropriate payment models may contribute to discouragement of primary care providers from remaining involved in certain aspects of EOL care. Despite the existence of closer doctor-patient relationships and better care integration and collaboration in rural settings compared to urban settings, limited awareness of local resources among primary care providers constrained their effective utilization. According to Crooks and colleagues [50], politics act as barriers by creating tensions and limiting choices through the regulation of “best practices” and hierarchical structure of organizations.
+
+Communication
+
+Effective communication between patients/families and care providers and all levels of care is at the core of quality healthcare. Six articles cited communication problems as a primary barrier for accessing adequate palliative care. Lack of communication played a significant role in the breakdown of advance care planning [25, 26, 32] and has a lasting emotional and psychological effect on family members who reported feeling unprepared for the ACP process [26]. Further, lack of communication between hospitals and primary care providers acts as a barrier to palliative care, leading to delayed referrals and discharges [32, 34, 47, 52] as well as anxiety among patients and their families or caregivers [52]. In their work, Ko and colleagues [22] focused on the role of patients and family members, finding that they also played a part in communication breakdown (e.g., lack of knowledge transfer).
+
+Knowledge
+
+Because specialized services are often rendered outside the community, many care providers, family members, and patients are unaware to both the services available, and the logistics of what care can or should look like in practice. Six articles referred to lack of knowledge as a primary barrier to care.
+
+Several studies identified lack of awareness of what palliative care is as a barrier to accessing this specialized care in rural, remote, and northern areas [22, 32, 35, 46, 54]. In fact, a large proportion of people can not differentiate between hospice and palliative care [53] or hold biases and skepticism towards the benefits of a palliative approach to care [35]. In their work, Aregay and colleagues [29] drew attention to how limited national leadership, societal norms and attitudes about chronic illness, and a lack of training and investments in palliative care have contributed to the overall lack of knowledge.
+
+Facilitators for improving access to palliative care in rural, remote, and northern areas
+
+Thirty-five articles noted facilitators for improving access to palliative care in rural, remote, and Northern locations, including: Collaboration [18, 30, 40, 48, 50, 56–61], Advanced Care Planning [22–25], Volunteers [44, 45], Education & Training [19, 32, 38, 53], Telemedicine [27, 28, 37, 62], Communication [24, 31, 52], and Community Based Care [12, 17, 20, 33, 43, 61].
+
+Collaboration
+
+A significant theme noted was the need for collaboration between patients and primary care physicians, and between primary care physicians and specialty care providers outside the patient’s home community. One article noted the many benefits of nurse practitioners working in a collaborative practice with primary care providers to negotiate a care plan via case conference [56], including timely initiation of care, increased follow-up, and a well-designed care plan that outlined the responsibilities of each care professional. This type of multidisciplinary collaboration could be effective in reducing patient utilization of other health care settings such as emergency rooms and hospitalizations in acute care settings [56, 61].
+
+Pesut et al. [40] reported people and families were highly satisfied with use of a nurse navigator to facilitate services (e.g., symptom management, advance care planning, psychosocial support, education) for older adults with advanced illness living at home. Others have demonstrated the effectiveness of collaborative approach between public and private sectors [30], specialized palliative care and community services [48, 50], between community-based health workers and community services [50, 57, 59], and within a shared care program [18]. In particular, the shared care model had the potential to reduce symptom-related suffering, leading to suggestions that collaboration among interdisciplinary teams could increase the ability for patients to die at home [60]. Watanabe et al. [58] also found that collaboration between rural clinics, local hospitals, and community services also enabled people to achieve an at-home death.
+
+Advanced care planning
+
+Although barriers exist to accessing advanced care planning (ACP) in rural palliative care, both formal and informal care providers have been found to be largely supportive of the process26, where some health care professionals consider it vital [23]. Factors that facilitated ACP included knowledge of EOL wishes, timing, education of and communication with primary care providers, education of patients and family members, and utilization of standardized processes to document and communicate wishes were noted as important to facilitate ACP [22–25].
+
+Volunteers
+
+Two articles mentioned the benefits of volunteers to facilitate palliative care in rural, remote, and northern communities. Specifically, help with transportation, meals, and emotional support [44] as well as with physical care, practical assistance, and liaising [45] had a positive impact on patients and families.
+
+Education & training
+
+Four articles cited the education and training of care professionals as facilitators. Lalani and Cai [32] identified professionals who were already trained and educated to identify needs for palliative care helped facilitate better outcomes, just as did those who promoted education among their care teams. Similarly, Koczwara et al. [38] found that education influenced approximately 75% of participants to change to the way they provided care. Both Aregay et al. [53] and Berke et al. [19] reported that education on cultural aspects of care, in addition to experience caring for people who are actively dying and advance care planning, had an important impact on outcomes.
+
+Telemedicine
+
+In the context of rural, remote, and northern areas - and especially in recent years, telemedicine is heavily relied on [63]. A recent study found that it is more positively adopted in rural settings, cited in part due to the “culture” of rural medicine and the perceived benefits of telemedicine [64] (e.g., quick response, access to clinicians, efficiency and quality of care) [37]. Successful integration of telemedicine in the context of rural palliative care, in part, requires awareness, trust and familiarity, and education and training [28]. Once implemented, telemedicine has been shown to improve symptom management [37, 62], reduce travel and emergency transportation [27], emergency room use [62], and hospice transfers [37].
+
+Communication
+
+Three articles clearly stated that communication was an important facilitator for care in rural, remote and northern communities. Veillette and colleagues [24] found that individuals and their families had better experiences when accessing care if communication between patient, friends, family, and healthcare providers was clear and remained effective. McVeigh and colleagues [52] also noted that clear communication regarding prognosis, and options for care contributed to better patient and family outcomes. Finally, Koski and colleagues [31] found that opening lines of communication between formal care providers and community members allowed for the provision of culturally sensitive care.
+
+Community based resources
+
+Of the thirty-five articles that discussed facilitators to care, six explicitly highlighted having access to options for community-based care as a primary facilitator of positive outcomes, including respite care facilities [12], community-managed PC [17, 33], and community-based advocacy [43]. Each of these studies suggested that community-based resources led to increased utilization of care and more positive care outcomes.
+
+Additionally, Weng et al. [61] implemented a community capacity building program to increase access to community-based care. Their findings point towards positive outcomes when communities successfully implement and sustain palliative care programs.
+
+Discussion
+
+This scoping review identified 53 studies on palliative care in rural, remote, and northern settings. Studies examined several issues (e.g., barriers and facilitators, roles, service use) from a variety of perspectives (e.g., patients, providers, family). Overall, it was clear that persons in rural, remote, and Northern regions face barriers in accessing timely and effective palliative care services.
+
+There is a clear need for change to policy, practice, and availability of services, as well as research that evaluates such changes. In particular, policy changes at all levels were cited as needed to improve access, quality, and outcomes of palliative care in rural, remote, and northern communities [29, 53]. To be effective, rural palliative care relies on the collaborative efforts of an interdisciplinary care team. Crooks and colleagues [50] identified three types of politics that are impacting palliative care in its present state: inter-community, inter-site, and inter professional. Among the three types of politics, each carry with it risk to both the services requested but to the patients as well. On the other hand, politics also act as facilitators for care in that they promote advocacy among those involved in care.
+
+Several studies focused on needed changes to practice - including use of informed, interdisciplinary, collaborative teams. The need to educate health care professionals on palliative care and approaches, and the roles and value of different professionals on the care team was highlighted as both important and warranting additional research. Several studies noted that providers held positive attitudes towards learning about palliative care and implementing evidence-based approaches to increase capacity for providing care locally. This is important, as they tend to have both close relationships with their patients and a deep understanding of unmet needs in the community. That said, professionals also need more information on how to best utilize the resources and technology available in their communities. The ability to leverage available resources in an effective way through collaboration and utilization of each member’s skills is paramount to the successful implementation of rural palliative care, especially in low-resource areas. In fact, collaboration was most often noted as an area for further research, with a heavy emphasis on how to best leverage existing community resources to improve access to palliative care. The need to understand the experience of health professionals providing care in the context of limited resources is important and should be more explicitly studied. Anxiety regarding the ability to meet the needs of residents is to be expected in rural, remote, and northern areas where resources are often already limited or over capacity. To ensure equitable access to care, a better understanding of professionals’ concerns is needed.
+
+There is a clear need for additional access to quality palliative care services in rural, remote, and northern communities. In particular, additional psychosocial support for individuals, families, and caregivers was most often mentioned. Availability of respite and home-making services, as well as social work and mental health supports would greatly impact the experiences of individuals and their families. Utilization and reliance on volunteers in rural, remote, and northern communities has been well-documented. However, further research should study the social and fiscal costs and benefits at both the individual and community levels. Many noted the role that telemedicine could play in providing access to needed services, while relieving the financial strain on patients, families, and the healthcare system as a whole. Future research that focuses on understanding the short and long-term benefits to individuals and families, as well as the contexts in which its use is most beneficial is needed. In addition, given acceptability and clinical and cost effectiveness, further evaluation of telemedicine and related innovative models of care are warranted.
+
+In the context of improving access to and the quality of care, patients provide an important perspective to understand gaps in care. However, given what people receiving palliative services are experiencing, their families and health care professionals are often the focus of studies. Inclusion of individuals as much as possible in research is needed and could be facilitated by reaching out earlier on in their journey. Often, retrospective analysis of records of clinical status and health service utilization is employed to understand the experiences of individuals at the end of life. While this allows examination of the experiences of a large number of people, the analyses conducted are often at a high level and do not consider the role of various sociodemographic factors, nor their intersectionality. When large datasets are available for analysis, consideration of sex, gender, ethnicity, race, language, disability, and other sociodemographic factors should be the standard. Further, retrospective analyses should consider individual and caregiver outcomes over time to understand the impact of different services, or lack thereof.
+
+In Canada, family members provide approximately 80% of all palliative care that is done at home [65]; as respite and home support is limited this number is likely higher in rural, remote, and northern areas. Because of this, family members, friends, and loved ones, especially those who provide care to patients in need of palliative care services provide invaluable contributions to research in this area. By prioritizing informal care providers in the research, the lived experiences and needs of this population, including patients can be understood when translating knowledge and considering the needs for future research and changes or additions to care.
+
+Strengths and limitations
+
+Our scoping review had several strengths, including mapping the focus of current research related to palliative care in rural, remote, and northern contexts, and inclusion of a large number of primary studies. Examination of terminology and definitions used for both key concepts (i.e., palliative care and rurality) was unique and showed the variability and interchangeable use of terms across studies. The review also had limitations, primarily related to exclusion of grey literature which may have led to potential publication bias in terms of the type of studies considered. However, given that much of the literature covered in this review employed qualitative designs, risk of publication bias is somewhat tempered. While we did not limit our review in terms of study aims or country, we acknowledge that most included studies are from high-income countries and focused on delivery of palliative care services rather than on system-level factors that shape delivery, for example.
+
+Conclusion
+
+As populations age, and the diagnosis of life-limiting chronic illness continues to rise, the pressure on governments and healthcare systems to develop and implement palliative care programs that adequately address the needs of patients in a timely manner is expected to peak in coming years. In Canada, and around the world, rural, remote, and Northern populations face unique challenges that need to be addressed to facilitate access to quality palliative care.
+
+While health care professionals have important insights and perspectives into the lived experience of patients and their families, the voices of individuals and families should be prioritized to truly understand the rural palliative care experience.
+
+Supplementary Information
+
+Supplementary Material 1.
+
+Supplementary Material 2.
+
+Abbreviations
+
+ACP Advance Care Planning
+
+EOL End of life
+
+HCP Health Care Provider
+
+PWLE Persons with Lived Experience
+
+PC Palliative care
+
+Acknowledgements
+
+The authors would like to acknowledge the support of Debra Gold, Communications and Copyright Librarian, and Trudy Russo, Special Collections Librarian, for assistance with the literature search strategy, as well as that of Anna De Jong and Kyle Swerhun with the data extraction. Production of this document has been made possible through a financial contribution from Health Canada. The views expressed herein do not necessarily represent the views of Health Canada.
+
+Authors' contributions
+
+N.M. conducted the literature search, and data extraction. N.M, L.M., and K.KM. contributed to the analysis of the results and to the editing and writing of the manuscript.
+
+Funding
+
+Production of this document has been made possible through a financial contribution from Health Canada. The views expressed herein do not necessarily represent the views of Health Canada. The funder had no role in the study design, data collection, analysis or preparation of the manuscript.
+
+Data availability
+
+This is a scoping review. All data generated during this study are included in this published article (i.e., Summary Table).
+
+Declarations
+
+Ethics approval and consent to participate
+
+The manuscript describes a scoping review based entirely on journal articles. As such, it did not involve human participants, human material, or human data and is exempt from ethical review.
+
+Consent for publication
+
+The authors confirm that the work submitted has not been published before; that it is not under consideration for publication elsewhere; that its publication has been approved by all co-authors.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
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+34. Näppä U Nässén E Winqvist I Palliative care in rural areas – collaboration between District Nurses and doctors: An interview study BMC Palliat Care 2023 10.1186/s12904-023-01190-9 37322520 PMC10268504
+Näppä U, Nässén E, Winqvist I. Palliative care in rural areas – collaboration between District Nurses and doctors: An interview study. BMC Palliat Care. 2023. 10.1186/s12904-023-01190-9.37322520 10.1186/s12904-023-01190-9 PMC10268504
+35. Prajitha KC Subbaraman MR Siddharth Raman SR Sharahudeen A Chandran D Sawyer J Need of community-based palliative care in rural India and factors that influence its sustainability: A comprehensive exploration using qualitative methodology in rural Puducherry, India Palliat Care Soc Pract 2023 10.1177/26323524231196315 37692560 PMC10486217
+Prajitha KC, Subbaraman MR, Siddharth Raman SR, Sharahudeen A, Chandran D, Sawyer J, et al. Need of community-based palliative care in rural India and factors that influence its sustainability: A comprehensive exploration using qualitative methodology in rural Puducherry, India. Palliat Care Soc Pract. 2023. 10.1177/26323524231196315.37692560 10.1177/26323524231196315 PMC10486217
+36. Spence W Ghosh S Palen M Liska A Ha V Wong R Symptom burden among northern Alberta radiotherapy patients with advanced cancer: Mapping needs and gaps Support Care Cancer 2020 10.1007/s00520-020-05330-2 32034512
+Spence W, Ghosh S, Palen M, Liska A, Ha V, Wong R, et al. Symptom burden among northern Alberta radiotherapy patients with advanced cancer: Mapping needs and gaps. Support Care Cancer. 2020. 10.1007/s00520-020-05330-2.32034512 10.1007/s00520-020-05330-2
+37. Bonsignore L Bloom N Steinhauser K Nichols R Allen T Twaddle M Evaluating the feasibility and acceptability of a telehealth program in a rural palliative care population: Tapcloud for palliative care J Pain Symptom Manage 2018 10.1016/j.jpainsymman.2018.03.013 29551433
+Bonsignore L, Bloom N, Steinhauser K, Nichols R, Allen T, Twaddle M, et al. Evaluating the feasibility and acceptability of a telehealth program in a rural palliative care population: Tapcloud for palliative care. J Pain Symptom Manage. 2018. 10.1016/j.jpainsymman.2018.03.013.29551433 10.1016/j.jpainsymman.2018.03.013
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+Koczwara B, Francis K, Marine F, Goldstein D, Underhill C, Olver I. Reaching further with online education? the development of an effective online program in Palliative Oncology. J Cancer Educ. 2010;25(3):317–23.20119693 10.1007/s13187-009-0037-6
+39. Pesut B Bottorff JL Robinson CA Be known, be available, be mutual: A qualitative ethical analysis of social values in rural palliative care BMC Med Ethics 2011 10.1186/1472-6939-12-19 21955451 PMC3195725
+Pesut B, Bottorff JL, Robinson CA. Be known, be available, be mutual: A qualitative ethical analysis of social values in rural palliative care. BMC Med Ethics. 2011. 10.1186/1472-6939-12-19.21955451 10.1186/1472-6939-12-19 PMC3195725
+40. Pesut B Hooper B Jacobsen M Nielsen B Falk M ‘Connor O Nurse-led navigation to provide early palliative care in rural areas: A pilot study BMC Palliat Care 2017 10.1186/s12904-017-0211-2 28583176 PMC5460511
+Pesut B, Hooper B, Jacobsen M, Nielsen B, Falk M, ‘Connor O. Nurse-led navigation to provide early palliative care in rural areas: A pilot study. BMC Palliat Care. 2017. 10.1186/s12904-017-0211-2.28583176 10.1186/s12904-017-0211-2 PMC5460511
+41. Larson KL Mathews HF Moye JP Congema MR Hoffman SJ Murrieta KM Four kinds of hard: An understanding of cancer and death among Latino community leaders Glob Qual Nurs Res 2021 10.1177/23333936211003557 33816705 PMC7992742
+Larson KL, Mathews HF, Moye JP, Congema MR, Hoffman SJ, Murrieta KM, et al. Four kinds of hard: An understanding of cancer and death among Latino community leaders. Glob Qual Nurs Res. 2021. 10.1177/23333936211003557.33816705 10.1177/23333936211003557 PMC7992742
+42. Raziee H Saskin R Barbera L Determinants of home death in patients with cancer J Palliat Care 2017 10.1177/0825859717708518 28662622
+Raziee H, Saskin R, Barbera L. Determinants of home death in patients with cancer. J Palliat Care. 2017. 10.1177/0825859717708518.28662622 10.1177/0825859717708518
+43. Reed F Fitzgerald L Bish M Advocating for end-of-life choice at home: A survey of rural Australian nurses Rural Remote Health 2018 10.22605/rrh4322 30125509
+Reed F, Fitzgerald L, Bish M. Advocating for end-of-life choice at home: A survey of rural Australian nurses. Rural Remote Health. 2018. 10.22605/rrh4322.30125509 10.22605/RRH4322
+44. Crooks VA Giesbrecht M Castleden H Schuurman N Skinner M Williams A Community readiness and momentum: Identifying and including community-driven variables in a mixed-method rural palliative care service siting model BMC Palliat Care 2018 10.1186/s12904-018-0313-5 29625598 PMC5889555
+Crooks VA, Giesbrecht M, Castleden H, Schuurman N, Skinner M, Williams A. Community readiness and momentum: Identifying and including community-driven variables in a mixed-method rural palliative care service siting model. BMC Palliat Care. 2018. 10.1186/s12904-018-0313-5.29625598 10.1186/s12904-018-0313-5 PMC5889555
+45. Jack BA Kirton J Birakurataki J Merriman A A bridge to the hospice’: The impact of a community volunteer programme in Uganda Palliat Med 2011 10.1177/0269216310397566 21402659
+Jack BA, Kirton J, Birakurataki J, Merriman A. A bridge to the hospice’: The impact of a community volunteer programme in Uganda. Palliat Med. 2011. 10.1177/0269216310397566.21402659 10.1177/0269216310397566
+46. Johns L McAuliffe D Dorsett P Psychosocial care provision for terminally ill clients in rural Australian communities: The Role of Social Work Rural Remote Health 2019 10.22605/rrh5285 31533435
+Johns L, McAuliffe D, Dorsett P. Psychosocial care provision for terminally ill clients in rural Australian communities: The Role of Social Work. Rural Remote Health. 2019. 10.22605/rrh5285.31533435 10.22605/RRH5285
+47. Johansen M-L Ervik B Talking together in rural palliative care: A qualitative study of interprofessional collaboration in Norway BMC Health Serv Res 2022 10.1186/s12913-022-07713-z 35255918 PMC8900365
+Johansen M-L, Ervik B. Talking together in rural palliative care: A qualitative study of interprofessional collaboration in Norway. BMC Health Serv Res. 2022. 10.1186/s12913-022-07713-z.35255918 10.1186/s12913-022-07713-z PMC8900365
+48. Munday D Haraldsdottir E Manak M Thyle A Ratcliff C Rural palliative care in north india: Rapid evaluation of a program using a realist mixed method approach Indian J Palliat Care 2018 10.4103/IJPC.IJPC_139_17 29440798 PMC5801626
+Munday D, Haraldsdottir E, Manak M, Thyle A, Ratcliff C. Rural palliative care in north india: Rapid evaluation of a program using a realist mixed method approach. Indian J Palliat Care. 2018. 10.4103/IJPC.IJPC_139_17.29440798 10.4103/IJPC.IJPC_139_17 PMC5801626
+49. Conlon MS Caswell JM Santi SA Ballantyne B Meigs ML Knight A Access to palliative care for cancer patients living in a northern and rural environment in Ontario, Canada: The effects of geographic region and rurality on end-of-life care in a population-based decedent cancer cohort Clin Med Insights Oncol 2019 10.1177/1179554919829500 30799969 PMC6378418
+Conlon MS, Caswell JM, Santi SA, Ballantyne B, Meigs ML, Knight A, et al. Access to palliative care for cancer patients living in a northern and rural environment in Ontario, Canada: The effects of geographic region and rurality on end-of-life care in a population-based decedent cancer cohort. Clin Med Insights Oncol. 2019. 10.1177/1179554919829500.30799969 10.1177/1179554919829500 PMC6378418
+50. Crooks VA, Castleden H, Hanlon N, Schuurman N. ‘heated political dynamics exist …Examining the politics of palliative care in rural British Columbia, Canada. Palliat Med. 2010;doi:10.1177/0269216310378784.10.1177/0269216310378784 20696737
+51. Ding J Saunders C Cook A Johnson CE End-of-life care in rural general practice: How best to support commitment and meet challenges? BMC Palliat Care 2019 10.1186/s12904-019-0435-4 31238934 PMC6593492
+Ding J, Saunders C, Cook A, Johnson CE. End-of-life care in rural general practice: How best to support commitment and meet challenges? BMC Palliat Care. 2019. 10.1186/s12904-019-0435-4.31238934 10.1186/s12904-019-0435-4 PMC6593492
+52. Mc Veigh C Reid J Carvalho P Healthcare professionals’ views of palliative care for American War veterans with non-malignant respiratory disease living in a rural area: A qualitative study BMC Palliat Care 2019 10.1186/s12904-019-0408-7 30813937 PMC6394001
+Mc Veigh C, Reid J, Carvalho P. Healthcare professionals’ views of palliative care for American War veterans with non-malignant respiratory disease living in a rural area: A qualitative study. BMC Palliat Care. 2019. 10.1186/s12904-019-0408-7.30813937 10.1186/s12904-019-0408-7 PMC6394001
+53. Aregay A O’Connor M Stow J Ayers N Lee S Palliative care in Ethiopia’s rural and Regional Health Care Settings: A qualitative study of enabling factors and implementation challenges BMC Palliat Care 2023 10.1186/s12904-023-01283-5 37845671 PMC10580684
+Aregay A, O’Connor M, Stow J, Ayers N, Lee S. Palliative care in Ethiopia’s rural and Regional Health Care Settings: A qualitative study of enabling factors and implementation challenges. BMC Palliat Care. 2023. 10.1186/s12904-023-01283-5.37845671 10.1186/s12904-023-01283-5 PMC10580684
+54. McLouth LE Borger T Bursac V Hoerger M McFarlin J Shelton S Palliative care use and utilization determinants among patients treated for advanced stage lung cancer care in the community and academic medical setting Support Care Cancer 2023 10.1007/s00520-023-07649-y 36847880 PMC9969037
+McLouth LE, Borger T, Bursac V, Hoerger M, McFarlin J, Shelton S, et al. Palliative care use and utilization determinants among patients treated for advanced stage lung cancer care in the community and academic medical setting. Support Care Cancer. 2023. 10.1007/s00520-023-07649-y.36847880 10.1007/s00520-023-07649-y PMC9969037
+55. Walter J Tufman A Leidl R Holle R Schwarzkopf L Rural versus urban differences in end-of-life care for lung cancer patients in Germany Support Care Cancer 2018 10.1007/s00520-018-4063-y 29399722
+Walter J, Tufman A, Leidl R, Holle R, Schwarzkopf L. Rural versus urban differences in end-of-life care for lung cancer patients in Germany. Support Care Cancer. 2018. 10.1007/s00520-018-4063-y.29399722 10.1007/s00520-018-4063-y
+56. Mitchell GK Senior HE Bibo MP Makoni B Young SN Rosenberg JP Evaluation of a pilot of nurse practitioner led, GP supported rural palliative care provision BMC Palliat Care 2016 10.1186/s12904-016-0163-y 27829425 PMC5103592
+Mitchell GK, Senior HE, Bibo MP, Makoni B, Young SN, Rosenberg JP, et al. Evaluation of a pilot of nurse practitioner led, GP supported rural palliative care provision. BMC Palliat Care. 2016. 10.1186/s12904-016-0163-y.27829425 10.1186/s12904-016-0163-y PMC5103592
+57. Potts M Cartmell K Nemeth L Qanungo S A qualitative evaluation of a home-based palliative care program utilizing community health workers in India Indian J Palliat Care 2019 10.4103/ijpc.ijpc_166_18 31114101 PMC6504743
+Potts M, Cartmell K, Nemeth L, Qanungo S. A qualitative evaluation of a home-based palliative care program utilizing community health workers in India. Indian J Palliat Care. 2019. 10.4103/ijpc.ijpc_166_18.31114101 10.4103/IJPC.IJPC_166_18 PMC6504743
+58. Watanabe J Teraura H Komatsu K Yamaguchi H Kotani K Predictors of at-home death for cancer patients in rural clinics in Japan Int J Environ Res Public Health 2021 10.3390/ijerph182312703 34886428 PMC8656844
+Watanabe J, Teraura H, Komatsu K, Yamaguchi H, Kotani K. Predictors of at-home death for cancer patients in rural clinics in Japan. Int J Environ Res Public Health. 2021. 10.3390/ijerph182312703.34886428 10.3390/ijerph182312703 PMC8656844
+59. Duggleby W Robinson CA Kaasalainen S Pesut B Nekolaichuk C MacLeod R Developing navigation competencies to care for older rural adults with Advanced Illness Can J Aging 2016 10.1017/s0714980816000131 27093177
+Duggleby W, Robinson CA, Kaasalainen S, Pesut B, Nekolaichuk C, MacLeod R, et al. Developing navigation competencies to care for older rural adults with Advanced Illness. Can J Aging. 2016. 10.1017/s0714980816000131.27093177 10.1017/S0714980816000131
+60. Klinger CA Howell D Marshall D Zakus D Brazil K Deber RB Resource utilization and cost analyses of home-based Palliative Care Service Provision: The niagara west end-of-life shared-care project Palliat Med 2012 10.1177/0269216311433475 22249926
+Klinger CA, Howell D, Marshall D, Zakus D, Brazil K, Deber RB. Resource utilization and cost analyses of home-based Palliative Care Service Provision: The niagara west end-of-life shared-care project. Palliat Med. 2012. 10.1177/0269216311433475.22249926 10.1177/0269216311433475
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+Weng K, Shearer J, Grangaard Johnson L. Developing successful palliative care teams in rural communities: A facilitated process. J Palliat Med. 2022. 10.1089/jpm.2021.0287.34762493 10.1089/jpm.2021.0287 PMC9081037
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+Ohta R, Ryu Y. Improvement in palliative care quality in rural nursing homes through information and communication technology-driven interprofessional collaboration. Rural Remote Health. 2021. 10.22605/rrh6450.33831305 10.22605/RRH6450
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+Shulver W, Killington M, Crotty M. Massive potential’ or ‘safety risk’? Health worker views on telehealth in the care of older people and implications for successful normalization. BMC Med Inf Decis Mak. 2016. 10.1186/s12911-016-0373-5.10.1186/s12911-016-0373-5 PMC5062826 27733195
+65. Stajduhar KI Burdens of family caregiving at the end of life Clin Invest Med 2013 10.25011/cim.v36i3.19722 23739665
+Stajduhar KI. Burdens of family caregiving at the end of life. Clin Invest Med. 2013. 10.25011/cim.v36i3.19722.23739665 10.25011/cim.v36i3.19722
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Microbiol
+Journal ID: Front Microbiol
+NLM Journal ID: 101548977
+Journal ID: Front. Microbiol.
+
+Frontiers in Microbiology
+
+EISSN: 1664-302X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13440252
+PMID: 42559141
+DOI: 10.3389/fmicb.2026.1927901
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Brain-gut-microbiota axis: a review on the bidirectional regulatory mechanisms between gut microbiota and brain and their disease interactions
+
+Shen Hui 1 2 3 †
+Wang Si Yun 1 4 †
+Zhao Yan Yan 1 4 †
+Zhou Jia Lin 1
+Zhao Jie 2 *
+Zhu Wei Kai 1 *
+1 Traditional Chinese Medicine Department, First Affiliated Hospital of Dalian Medical University, Dalian , Liaoning , China
+2 National-Local Joint Engineering Research Center for Drug Research and Development of Neurodegenerative Diseases, Dalian Medical University, Dalian , Liaoning , China
+3 College of Health-Preservation and Wellness, Dalian Medical University, Dalian , Liaoning , China
+4 Institute (College) of Integrative Medicine, Dalian Medical University, Dalian , Liaoning , China
+* Correspondence: Jie Zhao, zhaoj@dmu.edu.cn; Wei Kai Zhu, zhuweikai@firsthosp-dmu.com† These authors have contributed equally to this work and share first authorship
+
+Electronic publication date: 2026 Jul 22
+Publication date: 2026
+Volume: 17
+Electronic Location ID: 1927901
+Received 2026 Jul 4; Accepted 2026 Jul 6
+Copyright: Copyright © 2026 Shen, Wang, Zhao, Zhou, Zhao and Zhu.
+Copyright year: 2026
+Copyright holder: Shen, Wang, Zhao, Zhou, Zhao and Zhu
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Brain-gut-microbiota axis: a review on the bidirectional regulatory mechanisms between gut microbiota and brain and their disease interactions 17 27 3 2026 1768891 Frontiers in Microbiology 10.3389/fmicb.2026.1768891 PMC13066244 41971333
+Keywords: brain-gut-microbiota axis, gut microbiota, immune activation, microbial metabolites, neural pathways
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Microorganisms in Vertebrate Digestive Systems
+
+Ÿ==============================Ÿ
+Author Wei Kai Zhu was erroneously designated as a co-first author. Authors Hui Shen, Si Yun Wang and Yan Yan Zhao remain as co-first authors.
+
+The order of author affiliations was incorrect upon publication. The correct affiliation order is as follows:
+
+1Traditional Chinese Medicine Department, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
+
+2National-Local Joint Engineering Research Center for Drug Research and Development of Neurodegenerative Diseases, Dalian Medical University, Dalian, Liaoning, China
+
+3College of Health-Preservation and Wellness, Dalian Medical University, Dalian, Liaoning, China
+
+4Institute (College) of Integrative Medicine, Dalian Medical University, Dalian, Liaoning, China
+
+The original version of this article has been updated.
+
+Publisher's note
+
+All claims expressed in this articler are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Obes Surg
+Journal ID: Obes Surg
+NLM Journal ID: 9106714
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+Obesity Surgery
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+ISSN: 0960-8923
+EISSN: 1708-0428
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13038664
+PMID: 41553440
+DOI: 10.1007/s11695-026-08493-9
+Article ID: 8493
+Article version: 1
+Subjects: Correction
+
+Correction to: Safety of Bariatric Surgery in ≥ 65-Year-Old Patients during the COVID-19 Pandemic
+
+http://orcid.org/0000-0002-2797-2569 Singhal Rishi Singhal_rishi@hotmail.com
+1 2
+Omar Islam 3
+Madhok Brijesh 4
+Rajeev Yashasvi 5
+Graham Yitka 6 7
+Tahrani Abd A. 8 9 10
+Ludwig Christian 11
+Wiggins Tom 1
+Mahawar Kamal 6 12
+On behalf of the GENEVA Collaborators
+1 https://ror.org/014ja3n03 grid.412563.7 0000 0004 0376 6589 Upper GI unit, Birmingham Heartlands Hospital, University Hospital Birmingham NHS Foundation Trust, Bordesley Green East, Birmingham, West Midlands B9 5SS UK
+2 Healthier Weight, Birmingham, UK
+3 https://ror.org/05cv4zg26 grid.449813.3 0000 0001 0305 0634 General Surgery Department, Wirral University Teaching Hospital NHS Foundation Trust, North West, Wirral, UK
+4 https://ror.org/04w8sxm43 grid.508499.9 Upper GI unit, University Hospital of Derby and Burton NHS Foundation Trust, East Midlands, Derby, UK
+5 https://ror.org/04cntmc13 grid.439803.5 Pediatric Accidents and Emergencies Department, London Northwest University Healthcare NHS Trust, London, UK
+6 https://ror.org/04p55hr04 grid.7110.7 0000 0001 0555 9901 Faculty of Health Sciences and Wellbeing, University of Sunderland, North East, Sunderland, UK
+7 https://ror.org/02z9t1k38 grid.412847.c 0000 0001 0942 7762 Faculdad de Pyscologia, Universidad Anahuac, Anahuac, Naucalpan de Juárez, Mexico
+8 https://ror.org/03angcq70 grid.6572.6 0000 0004 1936 7486 Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
+9 Centre for Endocrinology, Diabetes, and Metabolism, Birmingham Health Partners, Birmingham, UK
+10 https://ror.org/014ja3n03 grid.412563.7 0000 0004 0376 6589 Department of Diabetes and Endocrinology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, West Midlands UK
+11 https://ror.org/03angcq70 grid.6572.6 0000 0004 1936 7486 Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, West Midlands UK
+12 https://ror.org/044j2cm68 grid.467037.1 0000 0004 0465 1855 Bariatric Unit, South Tyneside and Sunderland NHS Foundation Trust, North East, Sunderland, UK
+Electronic publication date: 2026 Jan 19
+Print publication date: 2026
+Volume: 36
+Issue: 3
+First page: 1393
+Last page: 1393
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Safety of Bariatric Surgery in ≥ 65-Year-Old Patients During the COVID-19 Pandemic 32 7 5 5 2022 1 13 Obesity Surgery 10.1007/s11695-022-06067-z PMC9071248 35513762
+issue-copyright-statement: © Springer Science+Business Media, LLC, part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Correction to: Obesity Surgery (2022) 32:1-13
+
+10.1007/s11695-022-06067-z
+
+The name of Geneva Collaborator 141 is incorrect. The correct name is Ahmet Bozdag.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
diff --git a/corpus/healthcare/text/6c55d38bfa58b162.txt b/corpus/healthcare/text/6c55d38bfa58b162.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Ann Surg Oncol
+Journal ID: Ann Surg Oncol
+NLM Journal ID: 9420840
+
+Annals of Surgical Oncology
+
+ISSN: 1068-9265
+EISSN: 1534-4681
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12765726
+PMID: 41266920
+DOI: 10.1245/s10434-025-18730-7
+Article ID: 18730
+Article version: 1
+Subjects: Correction
+
+Correction: Surgery for Retroperitoneal Soft Tissue Sarcoma is Safe Following Multimodal Treatment with Regional Hyperthermia
+
+Knoblauch Mathilda MD 1
+Werdel Cathy 1
+Arlt Yanik MD 1
+Lindner Lars H. MD 2
+Di Gioia Dorit MD 2
+Burkhard-Meier Anton MD 2
+Berclaz Luc MD 2
+Schmidt-Hegemann Nina-Sophie MD 3
+Schmidt Paul 4
+Werner Jens MD 1
+http://orcid.org/0000-0002-5028-5062 Albertsmeier Markus MD Markus.Albertsmeier@med.uni-muenchen.de
+1
+1 https://ror.org/05591te55 grid.5252.0 0000 0004 1936 973X Department of General, Visceral and Transplantation Surgery, Ludwig Maximilians Universität (LMU) Munich, LMU Hospital, Munich, Germany
+2 https://ror.org/05591te55 grid.5252.0 0000 0004 1936 973X Department of Medical Oncology, Ludwig Maximilians Universität (LMU) Munich, LMU Hospital, Munich, Germany
+3 https://ror.org/05591te55 grid.5252.0 0000 0004 1936 973X Department of Radiation Oncology, Ludwig Maximilians Universität (LMU) Munich, LMU Hospital, Munich, Germany
+4 Statistical Consulting for Science and Research, Berlin, Germany
+Electronic publication date: 2025 Nov 20
+Print publication date: 2026
+Volume: 33
+Issue: 2
+First page: 1725
+Last page: 1727
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Surgery for Retroperitoneal Soft Tissue Sarcoma is Safe Following Multimodal Treatment with Regional Hyperthermia 32 12 29 8 2025 9116 9126 Annals of Surgical Oncology 10.1245/s10434-025-18141-8 PMC12534312 40883536
+issue-copyright-statement: © Society of Surgical Oncology 2026
+
+Ÿ==============================Ÿ
+Correction to: Ann Surg Oncol (2025) 32:9116–9126 10.1245/s10434-025-18141-8
+
+In the published article, Tables 3 and 4 inadvertently omitted the modeled estimates of the Comprehensive Complication Index (CCI) by treatment group, which were included in the zero-inflated beta models as fixed effects. Table 3 has now been corrected to report the modeled probabilities of postoperative complications (CCI > 0) by treatment group, and Table 4 includes the expected CCI values (0 < CCI < 100) by treatment group. These corrections complete the presentation of the primary outcome but do not alter the study’s results or conclusions. The corrected Tables 3 and 4 are provided below. Table 3 Influence of neoadjuvant therapy, gender, transfusion, age, number of resected organs and recurrence on CCI in the model examining the probability of experiencing any postoperative complication (CCI > 0)
+
+	Risk CCI > 0 (Mean, 95% CI)	
+Neoadjuvant therapy	
+ No therapy (n = 155)	0.68 (0.57, 076)	
+ Chemotherapy (n = 10)	0.80 (0.54, 0.95)	
+ Radiotherapy (n = 17)	0.80 (0.61, 0.93)	
+ Chemotherapy + Radiotherapy (n = 7)	0.50 (0.21, 0.79)	
+ Chemotherapy + RHT (n = 36)	0.79 (0.65, 0.89)	
+ Chemotherapy + RHT + radiotherapy (n = 36)	0.78 (0.64, 0.89)	
+ p value	> 0.05 for all pairwise comparisons	
+Gender	
+ Female (n = 114)	0.73 (0.62, 0.82)	
+ Male (n = 147)	0,72 (0.6, 0.81)	
+ p value	0.77	
+Transfusion	
+ No (n = 132)	0.69 (0.58, 0.79)	
+ Yes (n = 53)	0.83 (0.71, 0.91)	
+ p value	0.03	
+Age (y)	
+ < 70	0.73 (0.63, 0.81)	
+ ≥ 70	0.70 (0.58, 0.80)	
+ p value	0.49	
+Number of resected organs	
+ < 3	0.57 (0.44, 0.69)	
+ ≥ 3	0.79 (0.62, 0.88)	
+ p value	0.004	
+Recurrence	
+ No	0.72 (0.62, 0.80)	
+ Yes	0.74 (0.59, 0.86)	
+ p value	0.65	
+RHT, regional hyperthermia
+
+Table 4 Influence of neoadjuvant therapy, gender, transfusion, age, number of resected organs and recurrence on CCI in the model examining the probability of experiencing the severity of postoperative complication (0 < CCI < 100)
+
+	Expected CCI (Mean, 95% CI)	
+Neoadjuvant therapy	
+ No therapy (n = 155)	30.2 (23.6, 37.7)	
+ Chemotherapy (n = 10)	24.8 (14.5, 38.2)	
+ Radiotherapy (n = 17)	32.7 (22.6, 45.1)	
+ Chemotherapy + Radiotherapy (n = 7)	20.9 (9.9, 38.7)	
+ Chemotherapy + RHT (n = 36)	36.1 (27.5, 46.0)	
+ Chemotherapy + RHT + radiotherapy (n = 36)	37.7 (28.6, 47.7)	
+ p value	> 0.05 for all pairwise comparisons	
+Gender	
+ Female (n = 114)	30.6 (24; 38.6)	
+ Male (n = 147)	30.5 (23.8; 38.7)	
+ p value	0.99	
+Transfusion	
+ No (n = 132)	29.3 (22.6, 37.1)	
+ Yes (n = 53)	36.8 (28.9, 46.5)	
+ p value	0.03	
+Age (y)	
+ < 70	30.2 (23.9, 38.0)	
+ ≥ 70	31.1 (23.9, 39.6)	
+ p value	0.83	
+Number of resected organs	
+ < 3	22.2 (16.5, 29.3)	
+ ≥ 3	34.1 (26.4, 43.3)	
+ p value	0.002	
+Recurrence	
+ No	30.5 (24.3, 38.2)	
+ Yes	35.8 (25.9, 47.1)	
+ p value	0.13	
+RHT, regional hyperthermia
+
+Corresponding changes have been made to Supplemental Tables 3 and 4, which report the zero-inflated beta models for primary tumor patients, as well as to Tables 7 and 8, which report the models for recurrent tumor patients.
+
+Supplementary Information
+
+Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 862 kb)
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
diff --git a/corpus/healthcare/text/6c88c08b4c5d9ea6.txt b/corpus/healthcare/text/6c88c08b4c5d9ea6.txt
new file mode 100644
index 0000000000000000000000000000000000000000..7c5f94eb57696edfcfeaa632261f8603f81c32b4
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@@ -0,0 +1,575 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Public Health
+Journal ID: BMC Public Health
+NLM Journal ID: 100968562
+
+BMC Public Health
+
+EISSN: 1471-2458
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13523198
+PMID: 42316081
+DOI: 10.1186/s12889-026-28065-x
+Article ID: 28065
+Article version: 1
+Subjects: Research
+
+Implementation of healthcare guidelines in public health: an umbrella review
+
+http://orcid.org/0009-0009-0913-5845 Ivanova Hristiyanna I. hristiyanna.ivanova@tno.nl
+
+http://orcid.org/0009-0006-4483-9715 Deurloo Jacqueline A.
+http://orcid.org/0000-0001-9417-7074 Lanting Caren I.
+https://ror.org/01bnjb948 grid.4858.1 0000 0001 0208 7216 Expertise Group Child Health, the Netherlands Organization for Applied Scientific Research (TNO), PO Box 2215, Leiden, 2301CE the Netherlands
+Electronic publication date: 2026 Jun 19
+Publication date: 2026
+Volume: 26
+Electronic Location ID: 2477
+Received 2026 Jan 13; Accepted 2026 Jun 2
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Umbrella review, Healthcare guidelines, Public health, Implementation, Barriers and facilitators, Implementation strategies
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Background
+
+Healthcare guidelines are intended to standardize health practitioners’ practice and improve patient outcomes, yet their implementation in public health is often inconsistent. This umbrella review aimed to identify barriers and facilitators influencing guideline implementation and to provide an overview of effective strategies to enhance guideline adherence in public health.
+
+Methods
+
+Systematic reviews and meta-analyses, published between 2014 and 2024, were identified through searches in PubMed (Q4 2024) and Scopus, CINAHL, and the Cochrane Database (Q2 2026). After applying the inclusion criteria, these were assessed for methodological quality using the AMSTAR-2 tool. Barriers, facilitators, and strategies were categorized using the Measurement Instrument for Determinants of Innovations (MIDI) framework to provide a comprehensive overview.
+
+Results
+
+Thirteen systematic reviews were included, most of which conducted qualitative syntheses, with only one meta-analysis identified. Organizational determinants were the most frequently reported barriers, including limited resources, insufficient coordination, and lack of management support. Factors related to healthcare professionals, such as perceived relevance of guidelines and alignment with practice, also influenced implementation. Facilitators included perceived usefulness of guidelines, professional engagement, and social support.
+
+A wide range of implementation strategies was identified, targeting organizational structures, end-users, and guideline characteristics. Educational approaches were the most applied but showed inconsistent effectiveness, especially when used in isolation. Evidence on the added value of multi-component strategies was mixed, with no single approach consistently associated with successful implementation.
+
+Conclusion
+
+Effective implementation of healthcare guidelines in public health requires a comprehensive approach addressing context-specific determinants. Although implementation challenges are shared across healthcare, the structural characteristics of public health often amplify organizational and end-user barriers. No single strategy ensures consistent success; instead, effectiveness depends on tailoring implementation efforts to specific settings and determinants. Further high-quality research is needed to identify effective implementation strategies and bridge the gap between evidence and daily public health practice.
+
+Registration
+
+This umbrella review was not registered in a publicly accessible database prior to its conduct.
+
+Supplementary Information
+
+The online version contains supplementary material available at https://doi.org/10.1186/s12889-026-28065-x.
+
+Introduction
+
+Healthcare guidelines are recommendations based on scientific evidence, aiming to improve the process of healthcare delivery as well as patient outcomes by guiding the practice of professionals in the clinical and public health sector [1]. These guidelines are designed to standardize healthcare practices across various settings and among practitioners. By incorporating patient values, they assist healthcare professionals and patients in making evidence-informed decisions about appropriate care in specific situations [2].
+
+Keeping up with new evidence presents a challenge for healthcare professionals, who must continually update and adapt their practices accordingly to reflect the latest evidence. To support this process, healthcare guidelines play a crucial role by synthesising, reviewing, and translating scientific evidence into actionable recommendations for practice. These guidelines are typically developed using an accepted step-by-step methodology, such as GRADE (Grading of Recommendations Assessment, Development, and Evaluation) to ensure their consistency and high quality [3, 4].
+
+The effectiveness of guidelines in improving healthcare practice and patient outcomes depends strongly on their implementation [1]. Implementation is the process of planned, deliberate activities aimed at putting well-defined actions and programs into practice [5, 6]. In this context, it refers to the adherence of healthcare professionals to guidelines in their practice.
+
+However, discrepancies in the uptake and use of guidelines are observed in clinical and public healthcare practices worldwide [7, 8]. For instance, Dutch studies report significant variation in adherence to guidelines for general practitioners (52% − 95%) and to discipline-specific public health guidelines (14% − 94%), such as those used in Youth Health Care (YHC) [9, 10]. Fixsen et al. [5] emphasize that, despite the potential effectiveness of interventions (i.e., healthcare guidelines), their ineffective implementation often leads to suboptimal use in practice and thus compromised patient outcomes.
+
+This signifies the need for a better dissemination of evidence-based guidelines, which can be achieved through well-designed implementation strategies [8, 11, 12]. These strategies encompass various methods to enhance guideline adoption and should be a fundamental component in any guideline development plan.
+
+While much literature exists on the implementation of guidelines in the clinical setting [13–19], these findings may not translate directly to the public health sector, which presents distinct challenges due to its population-level focus, multi-sectoral involvement, emphasis on prevention, equity of care, and broader societal goals.
+
+Despite its importance, there is a significant knowledge gap regarding how guidelines are adopted and applied in public health practice. This highlights the need for an updated, comprehensive review to better understand the implementation dynamics within this field. An umbrella review is particularly suitable for this purpose, as it synthesizes and evaluates findings from existing systematic reviews, offering the highest level of evidence [20].
+
+This umbrella review aims to address this knowledge gap by assessing the adherence to guidelines in the public health sector. Specifically, it seeks to: (1) identify the barriers and facilitators impacting their intended use, and (2) provide an overview of implementation strategies improving adherence outcomes. The insights from this review will serve to inform future guideline development and ultimately contribute to better patient outcomes.
+
+Methods
+
+Search strategy and eligibility criteria
+
+This review was conducted following the Preferred Reporting Items for Overviews of Reviews (PRIOR) methodology [21] (see Supplementary file 1). Systematic reviews and meta-analyses, employing a structured and transparent methodology to identify, select, critically appraise and synthesize findings from multiple studies, were identified via PubMed. The search took place in Q4 of 2024 and employed the following key terms:
+
+(“Diffusion of Innovation“[Mesh] OR implement*[Title] OR adoption[Title] OR quality improvement[Title] OR disseminat*[Title] OR diffusion[Title] OR knowledge transfer[Title])
+
+AND
+
+2. (“empirically supported treatment“[Title] OR “evidence-based practice“[Title] OR “evidence-based treatment“[Title] OR “evidence-based intervention“[Title] OR “guideline“[All Fields] OR “guidelines as topic“[MeSH Terms])
+
+AND
+
+3. (strateg*[Title] OR intervention*[Title] OR program*[Title] OR plan*[Title] OR process*[Title] OR model*[Title] OR framework*[Title] OR barriers[Title] OR limitations[Title] OR facilitators[Title] OR facilitating factors[Title])
+
+In Q2 of 2026, we conducted a second literature search in Scopus, CINAHL and the Cochrane Database of Systematic Reviews, using comparable search terms to ensure comprehensive coverage of the multidisciplinary nature of implementation research in public health. Complete search strategies for all databases are available in Supplementary file 2.
+
+Retrieved articles were considered for inclusion if they (a) were systematic reviews or meta-analyses written in English or Dutch, (b) were published between Q1 2014 and Q4 2024 in a peer-reviewed journal, (c) assessed barriers and facilitators to guideline adherence and/or strategies/theories of behaviour change aimed at improving guideline implementation, and (d) were conducted in public healthcare settings, specifically focusing on public health guidelines. Reviews focusing exclusively on clinical care without relevance to public health guideline implementation were excluded. However, given the limited availability of reviews conducted solely in public health settings, reviews including a combination of public health and clinical care settings were considered eligible when they addressed guideline implementation in preventive or population-oriented contexts.
+
+In the Netherlands, for example, public health is delivered through organizations such as Youth Health Care (YHC) and Municipal Public Health Service (GGD), which focus on preventive care and health promotion at the population level. However, internationally, the structure and delivery of public health services vary considerably, depending on national structures, resources, and priorities. Therefore, for the purposes of this umbrella review, studies conducted in primary care, community centers, school health services, and similar settings were considered. This approach acknowledges the diversity of public health delivery models worldwide and ensures that the review captures relevant evidence across different healthcare systems.
+
+Unpublished articles, case-reports, conference abstracts, and non-peer-reviewed sources were excluded. The main outcomes of interest regarding implementation strategies were (1) measures of professional practice effectiveness (such as guideline adherence, change in professional practice, documentation compliance, and referral patterns), (2) improved patient outcomes and (3) cost-effectiveness.
+
+Data extraction and quality assessment
+
+Screening and selection of literature occurred in two stages: initial screening of titles and abstracts with the use of ASReview software [22], followed by a manual full-text screening. Similarly to previous reviews [23, 24], 100 random titles and abstracts were screened in ASReview to estimate the total number of potentially relevant studies and to initialise the active learning model. Based on this initial sample, an upper 95% confidence limit of the number of relevant studies was calculated to guide the stopping point. In line with the SAFE (Stopping Active learning in sEarch) procedure [25], multiple stopping criteria were combined to ensure a balance between efficiency and sensitivity. Screening was continued until the estimated upper bound of relevant studies had been identified and a sequence of 100 consecutive records was labeled as irrelevant. To validate the stopping decision and minimize the risk of missing relevant studies, a validation step was performed by screening 50 of the lowest ranked (i.e., least relevant) records as predicted by the model. The absence of relevant studies within this subset was taken as an indication that no further relevant studies remained in the dataset.
+
+Any uncertainties or disagreements were resolved through discussion with all authors. The following data were extracted: (1) study characteristics, (2) study design and healthcare setting, (3) objectives, (4) outcome measures, (5) number of included studies and (6) quality appraisal. Additionally, findings were systematically summarized in a structured overview across reviews.
+
+The methodological quality of the literature was appraised using AMSTAR-2 (A MeaSurement Tool to Assess Systematic Reviews) [26]. Each review was evaluated based on the 16 items of the tool, and an overall rating was assigned: high (no or one noncritical flaw), moderate, low or critically low quality (more than one critical flaw with or without noncritical flaws).
+
+Data analysis
+
+We assessed overlap of primary studies across included systematic reviews by constructing a citation matrix (primary study × systematic review) and calculating the Corrected Covered Area (CCA) as described by Hennessy et al. [27]. Reviews without an extractable list of primary studies (e.g., [28]). were excluded from the CCA calculation but included in the qualitative synthesis.
+
+The Measurement Instrument for Determinants of Innovations (MIDI) tool was used to analyze the evidence on barriers, facilitators and strategies of guideline implementation [29]. This validated tool is specifically designed to categorize key determinants that can influence the successful implementation of innovations. In this review, the healthcare guidelines were considered the innovation to be implemented. The MIDI tool divides determinants into four domains: those related to the innovation itself (e.g., procedural clarity, complexity, relevance to the patient); those related to the end-user (i.e., person adopting the innovation), such as perceived benefits/drawbacks, professional obligation or sufficient knowledge; those regarding the organization (e.g., staff capacity and financial resources); and those regarding the socio-political context (e.g., legislation and regulations). To provide a comprehensive overview of the identified barriers and facilitators to guideline implementation, a template was developed. This template enabled thematic analysis and standardized the categorization of determinants according to the elements within the MIDI domains. The same procedure was applied to the implementation strategies. However, because some strategies address multiple elements within a single domain, a decision was made to categorize them only at the domain level. Disagreements were discussed with all authors until consensus was reached.
+
+To assess the impact of methodological quality, the results were further stratified by their overall AMSTAR-2 rating. This allowed for comparison of the outcomes across reviews and facilitated a sensitivity analysis, helping to identify potential discrepancies and strengthen the interpretation of the evidence.
+
+Results
+
+Summary of included reviews
+
+A total of 1114 articles were identified (Fig. 1). After deduplication and title and abstract screening, 33 full-text reviews were retrieved, and 13 met the preset inclusion criteria (see Table 1). Across the 12 systematic reviews with extractable individual studies, the citation matrix contained 17 primary studies appearing in more than one review and no primary study appearing in more than two reviews (maximum overlap = 2). The overall CCA was 0.54%, indicating minimal overlap according to established thresholds [30]. In line with current methodological guidance, this low level of overlap was interpreted as negligible, and no adjustments for overlap were deemed necessary.
+
+Table 1 Overview of included systematic reviews and meta-analyses
+
+Reference	First
+author	Year	Study design and healthcare setting	Objective(s)	Number of included studies	Outcome measures	Quality
+appraisal
+(AMSTAR-2)	
+[31]	Kovacs	2018	Systematic review and meta-analysis
+
+Primary healthcare
+
+	Evaluate the effect of intervention methods on the guideline adherence of primary care providers (PCPs).	36	Change in professional practice, impact on patient outcomes	Low	
+[32]	Heslehurst	2014	Systematic review
+
+Public health midwifery
+
+	Identify the determinants of healthcare professionals’ practice in relation to maternal obesity and weight management.	25	Implementation of pregnancy weight management and obesity guidelines by healthcare professionals	Critically low	
+[33]	Cassidy	2021	Systematic review
+
+Nursing care
+
+	Describe the use and effects of implementation strategies to facilitate the uptake of guidelines focused on nursing care.	41	Implementation of guidelines in nursing care
+
+Change in professional knowledge, professional practice, patient health status outcomes, resource use, and expenditures
+
+	Moderate	
+[34]	Häggman-Laitila	2016	Systematic review
+
+Nursing care
+
+	Review the literature on the outcomes of educational interventions relevant to nurses with regard to guideline implementation.	13	Guideline implementation using educational interventions in nursing
+
+Change in patient outcomes
+
+	Critically low	
+[35]	Mathieson	2018	Systematic mixed-studies review
+
+Community nursing
+
+	Identify the strategies required for, and the barriers and facilitators to, successful implementation	22	Implementation of evidence-based practice in community nursing	Critically low	
+[36]	Spoon	2020	Systematic review
+
+Nursing care
+
+	Provide an overview of strategies used to implement nursing guidelines in all nursing fields, as well as the effects of these strategies on patient-related nursing outcomes and guideline adherence	54	Implementation of nursing guidelines and impact on patient-related nursing outcomes	Low	
+[37]	Kovacs	2019	Systematic review
+
+Primary care
+
+	Review the economic evaluation of guideline implementation in primary care	39	Economic outcomes related to process of care and patient outcomes (e.g., quality of life)	Low	
+[38]	Mergelsberg	2023	Systematic review
+
+Primary care
+
+	Assess active ingredients, mechanisms of action, and implementation fidelity of interventions aimed at improving smoking cessation care	15	Impact on guideline adherence, counselling behaviour and quality of care	Critically low	
+[39]	Duda-Sikuła	2023	Systematic review
+
+Primary care and healthcare systems addressing health prevention
+
+	Identify best practice guidelines and policies influencing prevention strategies for chronic disease patients and to examine barriers and facilitators for their implementation	47	Implementation outcomes (implementation of prevention strategies and guidelines); system-level, organizational, and individual-level determinants	Critically low	
+[40]	Ray	2022	Systematic review
+
+Primary care
+
+	Synthesize evidence on primary care providers’ practices and perceived barriers and facilitators of implementing guideline-recommended childhood obesity prevention practices	50	Implementation-related outcomes (practice implementation, behavioural determinants, barriers/facilitators)	Moderate	
+[28]	Leeman	2015	Systematic review
+
+Community-based and public health settings (non-clinical prevention interventions)
+
+	Identify capacity-building strategies used to support practitioners in implementing evidence-based prevention interventions and assess their effectiveness	29	Implementation-related outcomes (adoption, implementation, practitioner capacity, planning behaviours)	Low	
+[41]	Agarwal	2021	Cochrane review
+
+Primary healthcare
+
+	Assess the effects of digital clinical decision-support systems (CDSS) delivered via mobile devices on quality of care and adherence to guidelines in primary care	8	Change in professional practice (guideline/protocol adherence), patient health behaviour, patient health outcomes, patient satisfaction	High	
+[42]	Jensen	2016	Systematic review and meta-analysis
+
+Primary healthcare
+
+	Identify and assess the cost-effectiveness of strategies for implementing low back pain guidelines in primary care and evaluate transferability of results	3	Change in professional practice (e.g., referrals), patient outcomes (e.g., functional capability, quality of life), cost-effectiveness	Critically low	
+
+Fig. 1 PRISMA flow diagram of search results [43]. A full list of excluded records is available in Supplementary file 3
+
+All reviews were published from 2014 to 2023 and conducted a qualitative synthesis of the evidence. Only one review performed a meta-analysis to quantitatively combine findings [31]. The included reviews synthesized evidence from a wide range of primary study designs, such as RCTs, cluster-randomized trials, controlled before–after studies, cohort studies, and other quasi-experimental designs, as well as observational studies (e.g., cross-sectional surveys) and qualitative or mixed-methods studies examining healthcare professionals’ experiences and behaviours.
+
+The number of primary studies ranged from 3 to 54, with an average of 29 studies per review. The reviews covered a range of healthcare fields, including primary healthcare practice (n = 7) [31, 37–42], (community) nursing care (n = 4) [33–36], public health midwifery (n = 1) [32] and community-based public health [28]. Across reviews, evidence was drawn from both public health settings (e.g., community nursing or preventive services) and clinical care settings (e.g., outpatient care) [28, 33–36, 38, 40, 41], or combined findings from public health guidelines (focused on population-level prevention) with those addressing clinical guidelines (focused on individual patient care) [31, 32, 37, 39, 42].
+
+Two reviews focused exclusively on barriers and facilitators of guideline adherence [32, 40], while six examined strategies to enhance guideline implementation [28, 31, 33, 34, 38, 41]. Three reviews examined both determinants of guideline adherence and implementation strategies [35, 36, 39]. Two reviews primarily assessed the cost-effectiveness of guideline implementation [37, 42]. An overview of the identified barriers and facilitators, categorized according to the MIDI instrument, alongside the implementation strategies reported in the included reviews, is presented in Table 2.
+
+Table 2 Overview of barriers and facilitators (based on the MIDI instrument [29]) and implementation strategies
+
+Barriers to guideline implementation related to the:	
+ End-user (i.e., the adopting healthcare professional)	
+  Lack of sufficient knowledge and skills [30, 33, 37, 38]	
+  Incompatible to professional obligations [33, 38]	
+  Low self-efficacy [38]	
+  Low outcome expectations [38]	
+  Limited client cooperation [30, 38]	
+ Organization	
+  Unsettled organization [33]	
+  Lack of coordination [33]
+
+  Lack of formal ratification by management [34, 37 , 38]
+
+	
+  Lack of available time [30, 33, 37, 38]	
+  Lack of replacement when staff leave [38]	
+  Insufficient staff capacity [33, 37]	
+  Limited/ inadequate financial resources [33, 37, 38]	
+  Limited/ inadequate material resources and facilities [37,38]	
+Facilitators to guideline implementation related to the:	
+ Innovation	
+  Complexity [33]
+
+  Observability [33]
+
+  Compatibility [33, 37]
+
+	
+  Correctness [37]
+
+  Relevance for client [33, 37]
+
+	
+ End-user (i.e., the adopting healthcare professional)	
+  Personal benefits [33]	
+  Client cooperation [30, 38]	
+  Outcome expectations [30, 38]	
+  Social support [30, 33]	
+  Subjective norm [30, 33]	
+Single-component implementation strategies related to the:	
+ Innovation	
+  Adaptation of guidelines to local context [31, 33, 34]	
+  Participatory/collaborative approaches during guideline development [31]	
+  Guideline (implementation) support tool [36, 39, 40]	
+ End-user (i.e., the adopting healthcare professional)	
+  Educational strategies [29, 31, 33, 34, 36, 37, 39]	
+  Educational outreach visits [29, 31, 34, 37]	
+  Ongoing support following initial training [31, 33, 39]	
+  Incentives [39]	
+ Organization	
+  Implementation teams [37]	
+  Local opinion leaders [31, 33, 34]	
+  Organizational policy changes [31, 36, 37, 39, 40]	
+  Leadership/ stakeholder involvement during implementation [36, 40]	
+  Audit and feedback [31, 34]	
+  Automated reminders [29, 31]	
+  Resource allocation [33]	
+ Multi-component implementation strategies	
+  Educational strategies with external facilitation and local adaptation of the guideline [31, 33]	
+  Educational strategies with organizational policy change [31, 33]	
+  Educational strategies with audit and feedback, and opinion leaders [29, 31, 34]	
+  Educational strategies with support tools [29, 32, 40]	
+
+Quality of included reviews
+
+The quality of the included reviews varied: the majority were rated as critically low [32, 34, 35, 38, 39, 42] and only one was of high quality [41], while the remaining reviews were of low to moderate quality (see Table 1 for the full quality assessment). Reviews rated as critically low showed notable methodological weaknesses, such as incomplete search strategies, limited or non-standard risk of bias assessment, insufficient consideration of heterogeneity and lack of transparency regarding excluded studies.
+
+Barriers to guideline implementation
+
+Five reviews discussed barrier assessment [32, 35, 36, 39, 40]. Of the identified barriers, 42% were related to the end-user (i.e., the adopting healthcare professional), and 58% to the organization where the guidelines were implemented. No determinants regarding the innovation itself or socio-political context were reported.
+
+Barriers related to the end-user
+
+“Knowledge” was identified as a barrier by four reviews [32, 35, 39, 40]. The lack of sufficient knowledge about recommended practices among healthcare professionals, as well as the absence of formal training on the use of healthcare guidelines, hindered their effective implementation. In addition, a lack of academic and communication skills also emerged as a barrier, particularly in counseling [32, 35, 40]. This included difficulties in addressing sensitive topics with patients, such as personal discomfort, anxiety or embarrassment when discussing these issues, fear of offending patients or provoking negative reactions or stigma, and concerns about damaging the practitioner–patient relationship.
+
+Other limitations within this domain included “professional obligation” [35, 39, 40],“self-efficacy” [40], “outcome expectations” [40] and “client cooperation” [32, 40]. Healthcare practitioners who perceive guidelines as incompatible with their roles or values, do not see guideline adoption as part of their professional responsibilities or disagree with its contents, or are skeptical about their effectiveness, are less likely to incorporate guidelines into their practice [35, 39, 40]. This also applies to practitioners who lack the confidence that they are able to implement change (i.e., low self-efficacy) [40] or practitioners who perceive patients as lacking motivation or engagement [32, 40].
+
+Barriers related to the organization
+
+Various organizational characteristics also appeared to influence the extent of guideline implementation.
+
+Mathieson et al. reported on the MIDI elements ‘unsettled organization’ and ‘coordination’ [35]. Infrastructural changes, such as restructuring of services or teams in an organization, require time and are prioritized in the daily practice of healthcare professionals, reducing the attention and effort they can devote to guideline implementation. Additionally, the absence of an appointed group of professionals, responsible for coordinating and monitoring the use of healthcare guidelines within an organization, hinders effective guideline implementation in practice.
+
+Other organization-specific barriers were related to the lack of “formal ratification by management” [35, 36, 39, 40], “time available” [32, 35, 39, 40], “replacement when staff leaves” [40], “staff capacity” [35, 39], “financial resources” [35, 39, 40] and “material resources and facilities” [39, 40]. A lack of leadership support and motivation towards end-users, along with the failure to establish formal arrangements regarding guideline use within the organization, limited their effective uptake [36, 39, 40]. Insufficient continuity of care, often caused by staff turnover, hindered the development of stable practitioner–patient relationships, thereby negatively affecting guideline implementation [40]. Staff shortages and insufficient personnel further restricted implementation by limiting the capacity to meet service demands [35, 39].
+
+Financial and time constraints also impeded implementation, as limited funding reduced access to protocols, training opportunities, and support structures, while limited consultation time, and competing priorities restricted the application of guidelines [32, 35, 39, 40]. Finally, a lack of material resources, such as equipment, decision-support tools, and patient educational materials, as well as restricted access to referral options, limited the practical application of guideline recommendations [39, 40].
+
+Facilitators to guideline implementation
+
+Four systematic reviews explored factors supporting the implementation of guidelines [32, 35, 39, 40]. Half of these factors were associated with the innovation itself and half concerned the end-user.
+
+Facilitators related to the innovation
+
+Within this domain of the MIDI tool, the following were identified as key elements supporting the adherence of healthcare practitioners to guidelines - “complexity” [35], “observability” [35], “compatibility” [35, 39], “correctness” [39] and “relevance for client” [35, 39]. Practical aspects of the guidelines themselves, such as ease of use, cost-effectiveness and time-efficiency, played a significant role in their acceptance. Higher uptake was observed when guidelines were perceived as compatible with existing professional values and routines, and when they could be adapted to the local, social, and cultural context [35, 39]. In addition, their evidence-based nature, enhanced credibility [39], while visible beneficial outcomes, such as improved patient care or stronger practitioner-patient relations, further supported adoption by professionals [35, 39]. Mathieson et al. emphasized that involving healthcare practitioners early in the guideline development process fosters a sense of ownership and increases the perceived relevance and applicability of guidelines in practice [35].
+
+Facilitators related to the end-user
+
+Facilitators identified within this domain included “personal benefits” [35], “patient cooperation” [32, 40], “outcome expectations” [32, 40], “social support” [32, 35] and “subjective norm” [32, 35]. Healthcare professionals were more inclined to adopt guidelines when their use contributed to personal benefits, such as professional development or gaining new knowledge or developing new skills [35]. Positive outcome expectations also played a key role: practitioners who believed that their preventive actions would lead to meaningful improvements in patient outcomes were more motivated to implement guidelines [32, 40]. Furthermore, the support, cooperation, and feedback from both patients and colleagues were seen as influential in shaping practitioners’ practice, thereby facilitating guideline implementation [32, 35]. Even when practitioners questioned their own readiness or competence to implement guidelines, strong and trust-based pre-existing professional-patient relations appeared to encourage successful adoption.
+
+Implementation strategies
+
+Ten systematic reviews investigated implementation strategies aiming to enhance guideline adoption in healthcare practice [28–42]. Each review assessed single-component implementation strategies, while five also examined strategies that combined multiple components (i.e., multi-component strategies) [31, 33, 34, 36, 41].
+
+Single-component strategies
+
+Half of the single-component strategies focused on addressing organizational challenges. Notably, none of the strategies targeted issues within the socio-political context.
+
+Implementation strategies related to the innovation
+
+Three implementation strategies related to the innovation were identified – adapting guidelines to the local context [33, 35, 36], using participatory/collaborative approaches [33] and the provision of practical tools to support guideline use in practice [28, 38, 41]. Contextual adaptation of the guidelines includes tailoring evidence-based recommendations to fit the specific practices and conditions of a local setting. This approach builds on the local knowledge and practice, making it easier for healthcare practitioners to integrate guidelines into their work. Participatory/collaborative strategies focus on the involvement of key stakeholders (e.g., healthcare professionals, patients, etc.) throughout all stages of the guideline development process. Considering their needs, insights and priorities leads to the development of healthcare guidelines, which are relevant and widely accepted.
+
+Additionally, providing practical tools, such as simplified guideline versions, physical information cards, implementation protocols or accessible web portals, supports implementation by facilitating day-to-day guideline use and improving accessibility for healthcare professionals in practice [28, 38]. In contrast, more advanced tools, such as digital clinical decision-support systems (CDSS), provide active, real-time support by guiding healthcare professionals through evidence-based decision-making processes, thereby directly supporting the application of guidelines during clinical encounters [41].
+
+Implementation strategies related to the end-user
+
+Within this domain, educational strategies were the most frequently used approaches to enhance the implementation of healthcare guidelines and were reported across all reviews reporting on implementation strategies [28, 31, 33, 35, 36, 38, 39]. While the approach varied, most of the strategies involved pre-planned educational sessions for healthcare practitioners prior to guideline rollout. Formats varied widely, including face-to-face lectures, workshops, seminars, web-based sessions, group discussions, and video presentations. Both passive (e.g., information provision) and active learning approaches (e.g., small group work, role-play, case-based learning, and patient simulations) were used to engage healthcare professionals.
+
+In some instances, external facilitators conducted outreach visits to deliver training, typically in a one-way format aiming to provide expert guidance [31, 33, 36, 39]. Inter-professional education was also applied in several cases, promoting collaboration and mutual learning across disciplines and thereby supporting a more integrated approach to guideline implementation. Moreover, passive educational tools, such as distributing a print of the guidelines, supplementary materials or self-study e-learning modules were also reported.
+
+Another strategy targeting end-users involved providing ongoing support following initial training [28, 33, 35]. This support could be provided from other staff members, creating opportunities to exchange positive and negative experiences with the use of the guidelines, or from the guideline developers through direct contact or via phone. Moreover, support from management also played a vital role by reinforcing expectations, allocating resources, and cultivating a supportive work environment that encourages the use of evidence-based practices.
+
+In addition, incentives were reported as a strategy to motivate engagement in implementation activities, such as offering financial compensation or training opportunities (e.g., scholarships), thereby encouraging healthcare practitioners to participate in and sustain guideline-related practices [28].
+
+Implementation strategies related to the organization
+
+Seven distinct strategies related to the organization were identified.
+
+A commonly used approach involves assigning specific roles to facilitate the implementation process. This included the formation of dedicated implementation teams, designating key individuals to lead implementation efforts, and appointing staff to monitor the progress [39]. In some cases, external experts were brought in to provide support and guidance throughout the implementation phase [33]. Another strategy included leveraging the influence of knowledgeable staff members as local opinion leaders, whose expertise and peer credibility promoted the adoption of guidelines within teams [33, 35, 36].
+
+Organizational policy changes as a way to enhance guideline use were also reported [28, 33, 38, 39, 41]. This strategy involved reforming current practice and integrating the guidelines within formal protocols, or standard operating procedures, therefore ensuring that their use becomes a required part of routine care. In addition, broader governance approaches, such as stakeholder engagement and leadership involvement, were reported to support implementation at a systems level [38, 41].
+
+Another strategy used to encourage changes in current practice and improve guideline adherence is ‘audit and feedback’ [33, 36]. This involves collecting data on guideline use, either using health records or direct observations by a third party. These findings are then summarized and shared with healthcare professionals to encourage reflection and promote improvements in practice.
+
+Another organizational component included the use of automated reminders containing the guideline essentials [31, 33]. These reminders were delivered via monthly email reminders or a pop-up window, integrated into health records, serving as a clinical decision support tool.
+
+Mathieson et al. briefly reported on organizational support, particularly through allocating resources to boost implementation of evidence-based healthcare guidelines [35]. This typically involves providing healthcare professionals with the necessary time to become familiar with new practices and investing resources to stimulate the integration of guidelines into standard care.
+
+Multi-component strategies
+
+The reviews also highlighted various combinations of implementation approaches to support the adoption of guidelines: multi-component strategies. These strategies are often centered around educational interventions, supplemented by organizational, contextual, or interpersonal components.
+
+A commonly reported combination involved pairing educational strategies with external facilitation and local adaptation of the guideline [33, 35]. Another frequently mentioned approach was the combination of educational efforts with organizational policy change [33, 35]. In these cases, guideline implementation was supported by embedding the recommendations into institutional protocols to ensure long-term sustainability.
+
+Several reviews also described strategies that combine education, audit and feedback, and the involvement of opinion leaders [31, 33, 36]. This configuration aimed to reinforce learning and promote adherence to guidelines through performance feedback, as well as the influence of respected peers within the organization.
+
+Lastly, education was also frequently combined with (technical) support tools, such as reminders and information cards to support consistent application of guidelines in daily practice [31, 34, 41].
+
+Effectiveness of implementation strategies
+
+Seven of the thirteen reviews [28, 31, 33, 34, 36, 37, 41] examined the effectiveness of implementation. Only one review conducted a meta-analysis [31], and one assessed the cost-effectiveness of strategies [37].
+
+Educational strategies were widely used in nearly all included studies (98%) but generally had low to moderate effectiveness [36]. While five studies showed improvements in professional practice following educational interventions, only two demonstrated an impact on professional knowledge, and two showed no measurable effect on patient health outcomes [33]. Passive educational methods (i.e., the distribution of materials) were consistently the least effective [31].
+
+Kovacs et al. found that single-component strategies demonstrated a greater average effect size (Standardized Mean Difference (SMD) = 0.27 [95% CI 0.17, 0.38]) compared to multi-component strategies (SMD = 0.13 [95% CI 0.06, 0.19]) [31]. These approaches were particularly effective in improving healthcare practitioners’ knowledge (SMD = 0.39) and had a moderate impact on diagnostic practices (SMD = 0.22) but showed little to no effect on patient health outcomes.
+
+In contrast, other reviews suggested that combining multiple components may enhance effectiveness. Häggman-Laitila et al. observed that combining multiple elements within a strategy yielded better outcomes, including improved practitioner confidence, sustained changes in professional practice, and improved quality of care [34]. Similarly, over two-thirds of studies employing multi-component strategies (68%) demonstrated significant improvements in patient outcomes or guideline adherence, although the median improvement did not differ significantly from single-component strategies (20.1% vs. 13.8%, p = 0.95) [36].
+
+Cassidy et al. found positive outcomes in 36 studies evaluating multi-component strategies, particularly regarding resource use (80%), professional knowledge (64%), and outcomes related to financial outcomes (63%) [33]. Leeman et al. similarly found that training, technical assistance, and support tools were generally effective in increasing guideline adoption (10/12 studies) and implementation (9/10 studies), although their effects on knowledge, skills, and planning behaviors were mixed [28]. Agarwal et al. also reported mixed effectiveness of digital decision‑support tools, with uncertain effects on provider adherence and patient outcomes [41].
+
+Economic evaluations, particularly from Jensen et al., indicated that implementation strategies (including educational and multifaceted approaches) showed conflicting results regarding cost-effectiveness [42]. While some interventions appeared cost-effective or even cost-saving, others showed no significant differences in costs or outcomes, highlighting variability in results across studies [37].
+
+Stratification of results
+
+To explore the influence of methodological quality, the findings were stratified. Categorization of the determinants of guideline implementation based on theoretical frameworks was consistent across reviews, regardless of methodological quality.
+
+Stratification showed that most implementation strategies were reported across reviews of varying methodological quality. No clear patterns were observed indicating that specific strategies were confined to higher- or lower-quality evidence. A small number of strategies were only identified in a single review, including participatory or collaborative approaches (moderate quality) [33], incentives (low quality) [28], and implementation teams and resource allocation (critically low quality) [35, 39]. However, these findings are based on limited evidence and do not indicate consistent quality-dependent patterns.
+
+Discussion
+
+This umbrella review synthesized evidence from thirteen systematic reviews to evaluate the implementation of guidelines in the public healthcare sector. In line with its broad objective, the review identified a range of obstacles faced by healthcare practitioners when adapting their practice to align with guideline recommendations, as well as facilitators and strategies that can enhance adherence.
+
+Organizational barriers emerged as the dominant influence on guideline implementation, indicating that successful uptake is largely shaped by structural conditions rather than individual behaviour alone. While organizational constraints are common across healthcare, the findings suggest they are often amplified in the public health context, which typically operates with limited resources, and less standardized infrastructure, making it harder to allocate dedicated time, staff, and facilities to guideline implementation. Unlike clinical settings with a hierarchical structure, public health systems rely on diffuse leadership and multi-sector collaboration. Because decision-making and service delivery often span multiple organizations, coordination and consistent implementation become inherently more complex.
+
+Although less frequently discussed, factors related to the healthcare practitioner revealed that implementation is not solely dependent on knowledge or training. Rather, adoption depends on the extent to which guidelines align with existing professional roles, values, and daily practice. Public health guidelines, which are designed to prioritize collective impact and flexibility across contexts, rather than individual patient needs or professional norms, may not always translate easily into individual practitioners’ routines. Practitioners working with specific subpopulations may therefore find generalized recommendations less applicable to their daily work. Moreover, because these guidelines are intended to be implemented across diverse professional roles, individual practitioners often do not feel direct ownership of implementation. This misalignment is thereby limiting for guideline adherence.
+
+Conversely, the findings suggest that implementation is facilitated when healthcare practitioners are actively involved in guideline development, as this enhances their perception of guidelines as relevant and applicable to practice. These insights underline the importance of designing guidelines that are not only evidence-based but also context-sensitive, user-oriented, aligned with existing workflows, and able to demonstrate visible benefits.
+
+A broad range of implementation strategies, both single-component approaches and multi-component strategies, was identified, reflecting the complexity of addressing barriers across multiple domains. Although educational strategies were the most frequently applied single-component strategy across the reviews, their effectiveness appeared inconsistent, particularly when delivered as passive interventions. This suggests that increasing knowledge alone is insufficient to drive sustained behavioural change.
+
+The evidence on the relative effectiveness of single-component versus multi-component strategies was mixed. Some reviews suggested no clear advantage of combining multiple strategies, while others indicated that multifaceted approaches may be more likely to produce meaningful improvements. Taken together, these findings indicate that no single strategy guarantees success. Instead, effectiveness likely depends on how well strategies are tailored to the specific context and the combination of barriers they are intended to address. Rather than focusing on specific strategies in isolation, efforts should aim to align interventions with relevant determinants at the level of the organization, the end-user, and the guideline itself. Such an approach acknowledges the dynamic interplay between these factors and may increase the likelihood of successful and sustainable implementation.
+
+Finally, stratified analyses did not reveal clear patterns linking methodological quality to specific strategies or determinants, suggesting that key implementation themes were relatively consistent across the evidence base. However, the identification of some strategies in only a single review indicates that the evidence remains fragmented, and further high-quality research is needed to clarify which approaches are most effective under specific conditions.
+
+In line with the observed fragmentation of the evidence, an important knowledge gap remains. The included reviews did not provide empirical evidence linking specific implementation strategies to particular barriers and facilitators. This limited the development of a practical overview that could serve as a tool to guide guideline implementation, as such an overview would necessarily rely on interpretative assumptions rather than empirically established relationships. An overview suggesting fixed relationships between determinants and strategies might therefore oversimplify the findings and imply causal links that are not sufficiently supported by the underlying evidence.
+
+In the Netherlands, a tool has been developed, which aims to support the implementation of various innovations within the public health sector [44]. Based on scientific literature and expert consensus using the Delphi method, this tool offers a range of effective strategies per element of the four MIDI domains. While this implementation tool offers an actionable framework, its focus is broad, addressing various types of innovations across public health. In contrast, this umbrella review provides a more targeted perspective by synthesising empirical findings from international studies specifically related to the implementation of healthcare guidelines. It identifies which strategies have been applied, under what conditions, and with what outcomes, thereby validating strategic choices and informing future guideline development efforts.
+
+Strengths and limitations
+
+A key strength of this umbrella review is its novelty. To our knowledge, this is the first umbrella review to specifically assess the implementation of healthcare guidelines within public health, a research area that has received relatively limited attention. By synthesising key findings published over the past decade, this review offers valuable insights to guide future guideline development.
+
+Moreover, this review adopts a broad and integrative approach by examining both determinants of guideline implementation and strategies aimed at improving their uptake in practice. This dual focus enhances its practical relevance for researchers, policymakers, and healthcare practitioners. Additionally, based on the MIDI-tool, this review employs a unique method of data synthesis. This structured approach enabled a comprehensive thematic analysis, supporting the applicability of these findings in future implementation efforts.
+
+From a methodological perspective, the negligible overlap of primary studies across the included reviews (CCA = 0.54%) suggests that the synthesis is unlikely to be influenced by double-counting of evidence and supports the robustness of the synthesis. In addition, the inclusion of a wide range of primary study designs, ranging from randomized trials to qualitative studies, allows for a comprehensive understanding of both effectiveness and contextual implementation factors.
+
+However, several limitations should be considered when interpreting the findings. First, the evidence base remains relatively limited, despite the increasing emphasis on evidence-based healthcare practice. Most included reviews relied on qualitative synthesis, with only one meta-analysis available, which limits the ability to draw robust conclusions about the effectiveness of implementation strategies. Moreover, the overall methodological quality of the included reviews was variable, with the majority appraised as critically low. This raises concerns regarding the reliability and strength of the overall evidence, particularly given issues such as incomplete reporting, limited risk of bias assessment, and insufficient handling of heterogeneity.
+
+Second, the included reviews combined evidence from both public health and clinical settings. While this reflects the available literature, it limits the extent to which findings can be attributed specifically to the public health context. Furthermore, no barriers and facilitators related to the socio-political context were identified, highlighting an important gap in the current evidence base.
+
+Third, the synthesis was constrained by differences in the applied theoretical frameworks across reviews, such as the Theoretical Domains Framework (TDF) [26], the Capability–Opportunity–Motivation Behaviour (COM‑B) model, and the Effective Practice and Organisation of Care (EPOC) taxonomy [27, 31, 32]. Mapping these on the MIDI framework was an interpretative step, which may have influenced categorization.
+
+Conclusion
+
+This umbrella review underscores that successful guideline implementation in the public health sector requires a comprehensive and systematic approach that accounts for all context-specific determinants. While most of the implementation challenges are not exclusive to public health, they are often amplified by its structural characteristics, including limited resources, diffuse governance, and multi-sector collaboration. Organizational factors emerged as key barriers, while successful implementation depends not only on knowledge but also on the alignment of guidelines with professional roles and practice contexts.
+
+The evidence indicates that no single implementation strategy consistently leads to successful guideline uptake. Instead, effectiveness appears to depend on how well strategies are tailored to the specific context and the combination of determinants they address. This underscores the importance of considering implementation early in the guideline development process and adopting a systematic approach that integrates factors related to the organization, the end-user, and the guideline itself.
+
+As the current evidence base within public health remains limited, rigorous, up-to-date research is required to ensure that evidence-based recommendations are effectively translated into practice and ultimately improve population health outcomes.
+
+Supplementary Information
+
+Supplementary Material 1.
+
+Supplementary Material 2.
+
+Supplementary Material 3.
+
+Acknowledgements
+
+Not applicable.
+
+Authors’ contributions
+
+All authors (HII, JAD, CIL) conceived the study. HII conducted the electronic literature search. All authors (HII, JAD, CIL) participated in screening and approval of included reviews. HII performed data extraction and quality assessment of included reviews. Disagreements were resolved between all authors. HII wrote the first draft of the article and all authors (HII, JAD, CIL) approved the final version.
+
+Funding
+
+None.
+
+Data availability
+
+All data analysed during this review is included in this published article and the supplement.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Not applicable.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Abbreviations
+
+AMSTAR-2 A MeaSurement Tool to Assess Systematic Reviews
+
+COM‑B Capability–Opportunity–Motivation Behaviour model
+
+EPOC Effective Practice and Organisation of Care taxonomy
+
+GRADE Grading of Recommendations Assessment, Development, and Evaluation
+
+MIDI The Measurement Instrument for Determinants of Innovations
+
+SMD Standard Mean Difference
+
+TDF Theoretical Domains Framework
+
+YHC Youth Health Care
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+Harrison Z, Bourke M, Gomersall SR. Examining the Effects of Mindful-Movement Interventions on Social, Emotional and Cognitive Outcomes in Children: A Systematic Review and Meta-Analysis. Child Care Health Dev. 2026;52(1):e70226. 10.1111/cch.70226.41429606
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+de Gans CJ, Burger P, Van den Ende ES, Hermanides J, Nanayakkara PWB, Gemke RJBJ, Stenvers DJ. Sleep assessment using EEG-based wearables–A systematic review. Sleep Med Rev. 2024;76:101951.38754209 10.1016/j.smrv.2024.101951
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+Boetje J, van de Schoot R. The SAFE procedure: a practical stopping heuristic for active learning-based screening in systematic reviews and meta-analyses. Syst Rev. 2024;13:81. 10.1186/s13643-024-02502-7.38429798 PMC10908130
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+27. Hennessy EA Johnson BT Examining overlap of included studies in meta-reviews: Guidance for using the corrected covered area index Res synthesis methods 2020 11 1 134 45 10.1002/jrsm.1390 PMC8555740 31823513
+Hennessy EA, Johnson BT. Examining overlap of included studies in meta-reviews: Guidance for using the corrected covered area index. Res synthesis methods. 2020;11(1):134–45. 10.1002/jrsm.1390.PMC8555740 31823513
+28. Leeman J Calancie L Hartman MA Escoffery CT Herrmann AK Tague LE Moore AA Wilson KM Schreiner M Samuel-Hodge C What strategies are used to build practitioners’ capacity to implement community-based interventions and are they effective? a systematic review Implement science: IS 2015 10 80 10.1186/s13012-015-0272-7 26018220 PMC4449971
+Leeman J, Calancie L, Hartman MA, Escoffery CT, Herrmann AK, Tague LE, Moore AA, Wilson KM, Schreiner M, Samuel-Hodge C. What strategies are used to build practitioners’ capacity to implement community-based interventions and are they effective? a systematic review. Implement science: IS. 2015;10:80. 10.1186/s13012-015-0272-7.26018220 PMC4449971
+29. Fleuren MA Paulussen TG Van Dommelen P Van Buuren S Towards a measurement instrument for determinants of innovations Int J Qual Health Care 2014 26 5 501 10 10.1093/intqhc/mzu060 24951511 PMC4195468
+Fleuren MA, Paulussen TG, Van Dommelen P, Van Buuren S. Towards a measurement instrument for determinants of innovations. Int J Qual Health Care. 2014;26(5):501–10.24951511 10.1093/intqhc/mzu060 PMC4195468
+30. Lunny C Pieper D Thabet P Kanji S Managing overlap of primary study results across systematic reviews: practical considerations for authors of overviews of reviews BMC Med Res Methodol 2021 21 1 140 10.1186/s12874-021-01269-y 34233615 PMC8265144
+Lunny C, Pieper D, Thabet P, Kanji S. Managing overlap of primary study results across systematic reviews: practical considerations for authors of overviews of reviews. BMC Med Res Methodol. 2021;21(1):140. 10.1186/s12874-021-01269-y.34233615 PMC8265144
+31. Kovacs E Strobl R Phillips A Systematic review and meta-analysis of the effectiveness of implementation strategies for non-communicable disease guidelines in primary health care J Gen Intern Med 2018 33 7 1142 54 10.1007/s11606-018-4435-5 29728892 PMC6025666
+Kovacs E, Strobl R, Phillips A, et al. Systematic review and meta-analysis of the effectiveness of implementation strategies for non-communicable disease guidelines in primary health care. J Gen Intern Med. 2018;33(7):1142–54. 10.1007/s11606-018-4435-5.29728892 PMC6025666
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+Heslehurst N, Newham J, Maniatopoulos G, Fleetwood C, Robalino S, Rankin J. Implementation of pregnancy weight management and obesity guidelines: a meta-synthesis of healthcare professionals’ barriers and facilitators using the T heoretical D omains F ramework. Obes Rev. 2014;15(6):462–86.24629076 10.1111/obr.12160
+33. Cassidy CE Harrison MB Godfrey C Use and effects of implementation strategies for practice guidelines in nursing: a systematic review Implement Sci 2021 16 1 102 10.1186/s13012-021-01165-5 34863220 PMC8642950
+Cassidy CE, Harrison MB, Godfrey C, et al. Use and effects of implementation strategies for practice guidelines in nursing: a systematic review. Implement Sci. 2021;16(1):102. 10.1186/s13012-021-01165-5.34863220 PMC8642950
+34. Häggman-Laitila A Mattila L-R Melender H-L A systematic review of the outcomes of educational interventions relevant to nurses with simultaneous strategies for guideline implementation J Clin Nurs 2017 26 3–4 320 40 10.1111/jocn.13405 27240188
+Häggman-Laitila A, Mattila L-R, Melender H-L. A systematic review of the outcomes of educational interventions relevant to nurses with simultaneous strategies for guideline implementation. J Clin Nurs. 2017;26(3–4):320–40. 10.1111/jocn.13405.27240188
+35. Mathieson A Grande G Luker K Strategies, facilitators and barriers to implementation of evidence-based practice in community nursing: a systematic mixed-studies review and qualitative synthesis Prim Health Care Res Dev 2019 20 e6 10.1017/S1463423618000488 30068402 PMC6476399
+Mathieson A, Grande G, Luker K. Strategies, facilitators and barriers to implementation of evidence-based practice in community nursing: a systematic mixed-studies review and qualitative synthesis. Prim Health Care Res Dev. 2019;20:e6. 10.1017/S1463423618000488.30068402 PMC6476399
+36. Spoon D Rietbergen T Huis A Heinen M van Dijk M van Bodegom-Vos L Ista E Implementation strategies used to implement nursing guidelines in daily practice: a systematic review Int J Nurs Stud 2020 111 103748 10.1016/j.ijnurstu.2020.103748 32961463
+Spoon D, Rietbergen T, Huis A, Heinen M, van Dijk M, van Bodegom-Vos L, Ista E. Implementation strategies used to implement nursing guidelines in daily practice: a systematic review. Int J Nurs Stud. 2020;111:103748. 10.1016/j.ijnurstu.2020.103748.32961463
+37. Kovacs E Wang X Strobl R Grill E Economic evaluation of guideline implementation in primary care: a systematic review Int J Qual health care: J Int Soc Qual Health Care 2020 32 1 1 11 10.1093/intqhc/mzz059 31290962
+Kovacs E, Wang X, Strobl R, Grill E. Economic evaluation of guideline implementation in primary care: a systematic review. Int J Qual health care: J Int Soc Qual Health Care. 2020;32(1):1–11. 10.1093/intqhc/mzz059.31290962
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+Mergelsberg ELP, de Ruijter D, Crone MR, Smit ES, Hoving C. Active Ingredients of Interventions Improving Smoking Cessation Support by Dutch Primary Care Providers: A Systematic Review. Eval Health Prof. 2023;46(1):3–22. 10.1177/01632787221099941.35594377
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+Duda-Sikuła M, Kurpas D. Barriers and Facilitators in the Implementation of Prevention Strategies for Chronic Disease Patients-Best Practice GuideLines and Policies’ Systematic Review. J personalized Med. 2023;13(2):288. 10.3390/jpm13020288.PMC9959826 36836522
+40. Ray D Sniehotta F McColl E Ells L Barriers and facilitators to implementing practices for prevention of childhood obesity in primary care: A mixed methods systematic review Obes reviews: official J Int Association Study Obes 2022 23 4 e13417 10.1111/obr.13417 PMC9285925 35064723
+Ray D, Sniehotta F, McColl E, Ells L. Barriers and facilitators to implementing practices for prevention of childhood obesity in primary care: A mixed methods systematic review. Obes reviews: official J Int Association Study Obes. 2022;23(4):e13417. 10.1111/obr.13417.PMC9285925 35064723
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+Agarwal S, Glenton C, Tamrat T, Henschke N, Maayan N, Fønhus MS, Mehl GL, Lewin S. Decision-support tools via mobile devices to improve quality of care in primary healthcare settings. Cochrane Database Syst Rev. 2021;7(7):CD012944. 10.1002/14651858.CD012944.pub2.34314020 PMC8406991
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+Jensen CE, Jensen MB, Riis A, Petersen KD. Systematic review of the cost-effectiveness of implementing guidelines on low back pain management in primary care: is transferability to other countries possible? BMJ open. 2016;6(6):e011042. 10.1136/bmjopen-2016-011042.27267108 PMC4908862
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+Theunissen M, van Empelen P, Fekkes M. De implementatietool: Meer dan 100 strategieën om een interventie of innovatie goed in te voeren. Leiden: TNO; 2022.
diff --git a/corpus/healthcare/text/775b460b577ff097.txt b/corpus/healthcare/text/775b460b577ff097.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Healthcare (Basel)
+Journal ID: Healthcare (Basel)
+NLM Journal ID: 101666525
+Journal ID: healthcare
+
+Healthcare
+
+EISSN: 2227-9032
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC10252209
+PMID: 37297776
+DOI: 10.3390/healthcare11111635
+Article ID: healthcare-11-01635
+Article version: 1
+Subjects: Review
+
+Methods of Primary Clinical Prevention of Dental Caries in the Adult Patient: An Integrative Review
+
+Veiga Nélio 1 2 *
+Figueiredo Ricardo 1
+Correia Patrícia 1 2
+Lopes Pedro 1 2
+https://orcid.org/0000-0002-0512-9757 Couto Patrícia 1 2
+https://orcid.org/0000-0003-3022-4390 Fernandes Gustavo Vicentis Oliveira 2 3
+Wiȩckiewicz Mieszko Academic Editor
+1 Faculty of Dental Medicine, Universidade Católica Portuguesa, 3504-505 Viseu, Portugal
+2 Centre for Interdisciplinary Research in Health (CIIS), Universidade Católica Portuguesa, 3504-505 Viseu, Portugal; gustfern@umich.edu
+3 Periodontics and Oral Medicine Department, University of Michigan School of Dentistry, Ann Arbor, MI 48109, USA
+* Correspondence: nveiga@ucp.pt
+Electronic publication date: 2023 Jun 2
+Publication date: 2023 Jun
+Volume: 11
+Issue: 11
+Electronic Location ID: 1635
+Received 2023 Apr 20; Revised 2023 May 29; Accepted 2023 Jun 1
+Copyright: © 2023 by the authors.
+Copyright year: 2023
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: primary prevention, adult, oral health, dental caries
+
+Funding: National Funds FCT—Fundação para a Ciência e a Tecnologia, I.P. UIDB/04279/2020 This work is financially supported by National Funds through FCT—Fundação para a Ciência e a Tecnologia, I.P., under the project UIDB/04279/2020.
+
+Ÿ==============================Ÿ
+Aim: Preventive approaches to oral health diseases, mainly dental caries, require individual and collective policies. Thus, this review was conducted to identify the primary prevention methods of dental caries in adults to improve oral health at the clinical and community levels. Methods: This review followed the PICO strategy with the research question: “What are the methods of primary prevention of dental caries, in adults, for improving and maintaining oral health integrating clinical and community-based strategies?” Electronic screening was carried out by two independent reviewers in five databases (MedLine/PubMed, SciELO, Web of Science, Cochrane Library, and LILACS) to find relevant publications between 2015–2022. We applied eligibility criteria for selection of the articles. The following MeSH terms were used: “Primary Prevention”; “Adult”; “Oral Health”; “Dental Caries”; “Fluorides, Topical”; “Fluoride Varnishes”; “Pit and Fissure Sealants”; “Preventive Dentistry”. Although the term “Prevention strategy” is not a MeSH descriptor, several correlated terms appeared and were used in the search engines: “Preventative Care”, “Disease Prevention, Primary”, and “Prevention, Primary”. The tool provided by the JBI organization (Joanna Briggs Institute) was used to assess the quality of the included studies. Results: Nine studies were included. Overall, it was found that the main primary prevention methods applied in dentistry in adults are the application of pit and fissure sealants, topical application of fluoride performed in the dental clinic, use of fluoridated toothpaste, mouthwash with chlorhexidine at home, use of xylitol, the recommendation for regular appointments with the dentist, and the need to inform patients about the saliva buffer capacity and adoption of a non-cariogenic diet. For that purpose, preventive policies should be taken to prevent dental caries. These include three major challenges: providing the adult population with more knowledge regarding their oral health, empowering patients through adopting healthy lifestyles, and developing new preventive strategies and awareness campaigns aimed at the adult population to promote proper oral health habits. Conclusions: A small number of studies were found whose participants were adult patients. There was some consistency regarding primary prevention methods in our studies. However, good quality randomized control studies are still required to define the best intervention strategies for adult caries prevention.
+
+1. Introduction
+
+1.1. Oral Health
+
+The International Dental Federation (IDF) defines oral health as “multi-faceted and included the ability to speak, smile, smell, taste, touch, chew, swallow and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and craniofacial complex diseases”. The IDF definition integrates oral health with general health, demonstrating that it affects overall health and well-being. Therefore, increasing awareness about the different dimensions of oral health and how they change over time empowers people by recognizing that values, perceptions, and expectations influence its outcomes [1]. The concept of oral health was extended with the addition of the feeling of well-being after the World Health Organization (WHO) expanded the definition of health by encompassing social well-being. Since then, oral health has been considered to also contribute to general well-being, not just the absence of pathologies. Everyday activities such as eating, talking, smiling, and contributing to society are included in a person’s well-being. Therefore, oral health is currently understood to be an integral part of overall health and well-being [2].
+
+A paradigm shift has occurred regarding health, disease causation, and healthcare delivery in medicine and dentistry. The medical model has been replaced by the socio-environmental model of health, which assumes health status as the capacity for optimal functioning and social and psychological well-being. Thus, oral health is a comfortable and functional dentition allowing individuals to continue in their desired social role [3]. The primary responsibility for maintaining oral health lies with the individual or their caretakers, which must be achieved through effective, evidence-based self-care. Still, public health policy support, education, professional monitoring, and therapeutic interventions are necessary. Self-care becomes more effective when individuals have oral health literacy and thus demand a functional and aesthetically appealing dentition. Dentistry, therefore, has a vital role in promoting strategies and methods of primary prevention of dental caries for improving and maintaining oral health [4].
+
+1.2. Primary Health Care and Its Promotion
+
+The concept of primary health care was defined at the Alma-Ata conference in 1978. Primary care for oral health is an integral part of primary health care. In 1984, the European WHO Discussion Document [5] defined health promotion as follows: health promotion involves the population as a whole, in the context of their daily lives, as opposed to focusing on people at risk of specific diseases; it is directed towards action on the determinants or causes of health; it combines diverse but complementary methods or approaches; it aims at particularly effective and concrete public participation; and health professionals have an important role in sustaining and enabling health promotion [5,6].
+
+Health promotion programs are effective if based on a holistic perspective of health, empowering citizens to manage their health, promoting equitable access to information, and leading to the adoption of healthy lifestyles [7]. Thus, several primary prevention methods applicable to oral health can be developed among adults, including behavioral factors, such as regular tooth brushing, dental flossing, a balanced diet, and regular dental checkups. These factors significantly reduce the risk of oral disease [8,9,10]. Currently, there is a paradigm shift in the treatment of dental caries, advocating a preventive approach, resulting in the conservation of dental structure [11,12].
+
+There are two primary clinical preventive strategies for reducing the risk of dental caries: topical fluoride application and fissure sealant application. Topical fluoride application is a more effective method on smooth tooth surfaces, while pit and fissure sealants are used successfully on the occlusal tooth surface [13,14,15,16]. Pit and fissure sealants prevent oral bacteria and carbohydrates, from the diet, from accumulating in the cavities and fissures and developing an acidic environment essential for developing the dental caries process. One advantage of pit and fissure sealant application is related to the fact that this is an easy technique without the need for local anesthesia [9]. Due to their liquid and fluid consistency, sealants flow over the irregular surface of grooves and fissures, filling all the porosities present, sealing the regions that retain bacterial plaque and, as a result, preventing and/or delaying the appearance of occlusal dental caries. On the other hand, pit and fissure sealants are mainly characterized by their fluoride-releasing action [17,18,19,20].
+
+Another approach to prevent caries is the use of xylitol. It has been used since the early 1960s in the diet of diabetic patients and, most recently, as a sweetener in products aimed at improved oral health [21,22]. Xylitol disrupts the energy production processes of mutans streptococci, leading to a futile energy consumption cycle and cell death. Moreover, it reduces plaque formation and bacterial adherence and inhibits enamel demineralization [23]. The first xylitol studies in humans showed the relationship between dental plaque and xylitol and the safety of xylitol for consumption [24]. The first chewing gum developed with the aim of reducing caries and improving oral health was released in Finland in 1975 [9]. Since then there have been various products introduced and sold over the counter and applied professionally worldwide. It has demonstrated to be an effective strategy as a self-applied caries preventive agent [21], and the recommended dose for dental caries prevention is 6–10 g/daily [25].
+
+1.3. Fluoride Therapy
+
+Fluoride has played an essential role in protecting enamel. Therefore, the relationship between fluoride and demineralization reduction is log-linear [26,27]. Evidence shows that fluoride is more effective than calcium [28] and can be found in various forms and concentrations, such as toothpaste, mouthwashes, gels, and varnishes [29]. Evidence reports that fluoride toothpaste (1000 to 1500 ppm) effectively reduces dental caries rates [30]. A systematic literature review [31] showed that fluoride toothpaste (1000 to 1250 ppm fluoride) was more effective than non-fluoride toothpaste in reducing dental caries rates. Fluoride mouthwash typically has 0.05% sodium fluoride, corresponding to a solution with approximately 230 ppm of fluoride [32]. In turn, fluoride varnishes have 5% sodium fluoride (22,600 ppm) as the active agent and can be used to prevent dental caries [33,34,35,36,37]. Fluoride varnish treatments effectively stop the progression of tooth demineralization, reducing dental caries significantly by approximately 50% to 70% in dental pits and fissures. Their effectiveness is even greater on interproximal surfaces. The beneficial effect of varnishes on permanent teeth is thus recognized [38,39,40]. Patients at high risk of dental caries, namely patients with xerostomia, and elderly patients at risk of root caries, may benefit from boosters to improve the remineralizing and preventive efficacy of fluoride [41,42].
+
+1.4. Dental Caries
+
+However, dental caries is the most prominent oral health problem affecting most adults, including in industrialized countries. The prevalence of dental caries in permanent dentition in Portugal has been decreasing significantly, as reported by national studies, reaching very satisfactory levels, particularly in individuals who benefit from the activities developed under the National Program for Oral Health Promotion (Programa Nacional de Promoção da Saúde Oral, PNPSO) [43,44].
+
+The WHO’s global oral health assessment shows that while there has been a significant improvement in many countries, untreated dental caries is still a significant global burden: “The current pattern, within dental caries and periodontal disease, reflects the different risk profiles in different countries (the living conditions, lifestyles, and environmental factors) and, in particular, the result of the implementation of oral health promotion programs” [45,46]. One significant challenge today is the unmet treatment needs of adult patients, indicating limited access to dental care and insufficient primary prevention efforts. Therefore, the adult population still experiences significant complications due to untreated caries. Thus, more measures must be adopted by the NHS, as well as by health entities and professional organizations, to minimize the prevalence of dental caries in the world, particularly in Portugal [47].
+
+Developing preventive interventions at the primary prevention level can lead to potentially sustainable normative support for oral hygiene, locally tailored and targeted approaches, and ongoing positive changes in specific oral health practices. Such interventions can reduce the short- and long-term psychosocial and economic costs associated with disabling oral health problems and help prevent the exacerbation of chronic and disabling diseases [48,49,50]. Nowadays, there are high-standard treatments for untreated caries [51], but this may negatively affect the NHS and patients either from a health or from an economic point of view [52].
+
+Currently, primary prevention strategies should consider models of behavioral change and patient empowerment linking oral health to a healthy lifestyle, considering the following parameters: capacity, opportunity, motivation, the feeling of appreciation, behavior, and patient-centered strategies. Moreover, the current health perspective includes a holistic, global, and integrative approach in a predictive, preventive, personalized, and participatory vision. The biggest challenge for community oral health is to promote proactive strategies in adult patients. Therefore, collaboration work and stakeholder networking will be the key to success. This requires the effective use of education strategies [53,54,55,56,57].
+
+Therefore, this review is an adjunct to understanding the main factors involved in patent neglect in this specific age group and may help define future strategies and recommendations to ensure greater efficacy and application of preventive treatments in adults. Then, the aim of this review was to gather the current available information on strategies and methods of primary prevention of dental caries in adults to improve and maintain oral health.
+
+2. Materials and Methods
+
+2.1. Search Strategy and Eligibility Criteria
+
+The present review was registered in PROSPERO (CRD42021243161). According to the PI[C]O framework, the following research question was defined [58]: “What are the methods of primary prevention of dental caries (I) in adults (P) for improving and maintaining oral health integrating clinical and community-based strategies (O)?” The following eligibility criteria were defined and described in Table 1.
+
+2.2. Study Search Strategy
+
+For the identification of relevant studies in accordance with the defined criteria, searches will include studies published between 2015 and 2022 in Portuguese, Spanish, and English using the following electronic databases: MedLine/PubMed, SciELO, Web of Science, Cochrane Library, and LILACS. The exclusion of studies before 2015 is due to a similar article published in 2016 which included articles up to 2015 [16], and thus we are trying to provide results from more recent studies. The following MeSH terms were used, retrieved from MeSH Descriptor Data https://meshb.nlm.nih.gov/search (accessed on 22 January 2020): “Primary Prevention”—MeSH Heading; “Adult”—MeSH Heading; “Oral Health”—MeSH Heading; “Dental Caries” MeSH Heading; “Fluorides, Topical”—MeSH Heading; “Fluoride Varnishes” MeSH Heading; “Pit and Fissure Sealants” MeSH Heading; “Preventive Dentistry” MeSH Heading. Although the term “Prevention strategy” is not a MeSH descriptor, several correlated terms appeared and were used in the search engines: “Preventative Care”, “Disease Prevention, Primary”, “Prevention, Primary”. All these descriptors were conjugated with the Boolean operators “AND” and “OR”. In the mentioned scientific search engines, these descriptors were used in Portuguese, Spanish, and English for article retrieval.
+
+2.3. Screening and Data Extraction
+
+Two independent reviewers (NV and RF) were responsible for the searches and screening of the articles. After eliminating duplicates, the articles passed through 3 stages: (i) reading of the title, (ii) reading of the abstract, and (iii) reading the full text. In disagreement, a third reviewer (PC) broke the tie. The same independent reviewers selected data from each included article and recorded them in an Excel® sheet (version 15.17, Microsoft, Redmond, Washington, DC, USA). Any potential disagreement and/or discrepancy was resolved by consensus and in the presence of a third reviewer (PC). The following variables were defined in this investigation: Authors and year of publication, title, study design, participants, objective, and results.
+
+2.4. Quality Assessment/Risk of Bias
+
+The tool provided by the JBI organization (Joanna Briggs Institute, University of Adelaide, North Adelaide, Australia) was used to assess the quality of the included studies. The purpose of this tool was to evaluate the methodological quality of research and determine the extent to which the possibility of risk of bias has been addressed in its design, execution, and analysis. It included 11 questions (final score ranging from 0 to 11, 0% to 100%), with the following responses: yes (1), no (0), undefined (UND), and not applicable (N/A). A value below 50% indicates a low quality of the article; between 50 and 69% corresponds to moderate quality, and ≥70% reflects a high quality [59].
+
+3. Results
+
+A total of 899 articles were identified. In the first step, duplicate studies were removed from the databases (n = 98). In the second phase, out of 801 articles, 78 were excluded by reading their titles and abstracts, resulting in 723 articles. This large number was found because the title and the abstract did not provide enough information in order to exclude the article, which led us to include a great number for full-text reading. From these, 714 were excluded for failing to meet the other inclusion criteria, namely: 397 for participants (most studies conducted in children and adolescents; 102 for interventions; 101 because the results did not answer the research question; 114 whose study design did not fall within those recommended for a review of the literature, being mostly secondary studies). Thus, nine articles [60,61,62,63,64,65,66,67,68] were included in the study after applying quality assessment tools (k = 0.99) (Figure 1).
+
+Table 2 summarizes the results of the nine studies included in this review, considering: authors/year of publication, article name, study design participants, objective, and results. The quality assessment showed (Table 3) that the articles included in this review had values greater than 70% and were considered high quality, except for one which presented results with lack of information and was of moderate quality.
+
+4. Discussion
+
+The present review answered the research question on the primary prevention of dental caries in adults. It permitted us to understand the improvement and maintenance of oral health at clinical and community levels, involving: (i) fluoride application in the office; (ii) recommending the use of fluoride toothpaste; (iii) performing mouth rinses with chlorhexidine at home; (iv) recommending the use of xylitol; (v) treatments with fluoride varnishes in dental pits and fissures; (vi) more frequent visits to the dentist; (vii) adopting a non-cariogenic diet, i.e., alerting patients to the frequency of sugar consumption; (viii) brushing correctly; and (ix) alerting patients to the protective role of saliva in dental caries.
+
+The studies included in this review were mostly cross-sectional studies, with one retrospective cohort study and one qualitative study, presenting various strategies for primary prevention of dental caries in the adult population from different countries. The individual analysis showed significant homogeneity in the design of the studies, specially concerning cross-sectional studies. There was substantial heterogeneity regarding the sample, the variables studied, and the type of intervention applied, which made it impossible to perform a meta-analysis. Briefly, these studies included dental practitioners, dental students, dental committee members, and insurance company members, aiming to evaluate the preventive measures for dental caries in adult patients. Most studies considered the participants’ knowledge and awareness of preventive measures.
+
+4.1. Types of Caries Prevention
+
+It is known that there exist many types of caries prevention, such as dietary control, oral hygiene, topical antimicrobials, pit and fissure sealants, and fluoride therapy and supplements. A dietary diary can be considered in cases of moderate/high risk of caries, leading to a specific dietary counselling. Therefore, its compliance should be monitored in recall visits [68]. In addition, oral hygiene with tooth brushing is an efficient mechanical method to remove dental plaque. Skills of toothbrushing must be reviewed/taught and the patient should be encouraged to brush their teeth at least twice a day, especially before bedtime. Furthermore, the use of fluoridated toothpaste should be emphasized [69], which can reduce the risk of development of caries [68].
+
+Fluoride mouthrinses can be also considered; however, this is not recommended in fluoridated communities and for children under 6 years old (risk of ingestion). The two main concentrations available are 0.05% (225 ppm F) NaF, and 0.2% (900 ppm F) NaF, for daily and weekly uses, respectively [68]. Fluoride gel is produced by the addition of a gelling agent, increasing its viscosity. It may lead to a 28% reduction in the risk of dental caries. The most used gel has 12,300 ppm of Acidulated Phosphate Fluoride (APF), which is applied to teeth by the tray technique [68]. Fluoride supplements are provided in the form of tablets, lozenges, drops, liquids, and fluoride-vitamin preparations. All potential fluoride sources should be evaluated, and a caries risk assessment should be conducted before prescribing them, to reduce the risk. At low caries risk, the supplements are not recommended, and other sources of fluoride should be considered as a preventive measure [70]. Fluoride therapy can have systemic and topical effects. In case of the water fluoridation, there is a release of F compound into a public water supply to bring the F ion concentration up to a level that effectively prevents caries. The optimal F concentration in drinking water is a range of 0.7–1.2 ppm, depending on the climate, according to the WHO guidelines. This method reduces dental caries experience by the half [71]. Those patients with higher risk of developing caries should use a standard of 1000 ppm paste [72].
+
+Fluoride varnish is a professionally applied adherent material and is not intended to be as permanent as pit and fissure sealant. It is effective in preventing new carious lesions and halting the progression of established ones. The application of high F concentrations, around 22,000 mg F/L, leads to slow release of F into the surrounding environment. This release has been shown to continue for 5–6 months [70]. It typically contains 5% sodium F (NaF), which is equivalent to 2.26% F (Duraphat), and an organic F varnish which contains 0.1% F (Fluor Protector) is available. This is applied to teeth by the paint-on technique [73].
+
+Sealant is a low viscous material that is placed in the pits and fissures on occlusal, buccal, and lingual surfaces of teeth to prevent or arrest the development of caries. Sealants have been used for over 30 years as a caries preventive measure and evidence from clinical trials has demonstrated their effectiveness [74]. Applying a fissure sealant decision should be made on clinical bases, after a full clinical examination that is supported by a caries risk assessment. Applying a sealant over an incipient carious lesion (noncavitated carious lesion) does not lead to progress if this sealant remains intact. However, if caries is found to extend to dentine, a restoration should be placed [73]. It is recommended to use the sealants compared with both nonuse of sealants and use of fluoride varnishes in permanent molars with both sound occlusal surfaces and noncavitated occlusal carious lesions. Nevertheless, sealant is contraindicated if patient behavior does not permit isolation, there is an open occlusal carious lesion, caries exists on other surfaces of the same tooth, a large occlusal restoration is already present, or if pits and fissures are well coalesced and self-cleansing [75].
+
+The use of topical antimicrobials (chlorhexidine and xylitol) can help with prevention, reducing the burden of bacteria [76]. Chlorhexidine is the gold standard antibacterial agent which reduces the mutans streptococci levels. Several over the counter and professionally administered chlorhexidine-based preparations are available, as toothpastes, mouthrinses, varnishes, gels, and gums and sprays [77]. The use of xylitol can also reduce levels of caries-forming mutans streptococci in plaque and saliva. It can be administered in gum, lozenges, or snack foods [76].
+
+4.2. Findings and Contrast with the Literature
+
+Tagliaferro et al.’s study [60] investigated the procedures used by dentists in a Brazilian community to prevent the carious process in adult patients. They indicated that the procedures used were pit and fissure sealants, fluoride application in the office, the recommendation to use fluoride toothpaste, mouth rinses with chlorhexidine at home, and advice to use xylitol as a replacement for sucrose in the diet. This result agrees with Nassar’s study [61], which evaluated the awareness and knowledge of dental students regarding the preventive measures for dental caries in adult patients. As result, the students mentioned that the practical measures for the prevention of dental caries in patients include the recommendation of oral hygiene, xylitol, application of fluoride in the office and its use at home, use of chlorohexidine, and recommendations about the importance of a protective diet against dental caries. These findings coincide with Wagle et al.’s study [67]. The authors aimed to describe the practices of Nepalese dentists regarding preventive education and treatment in patients, where the dentists advised patients about the use of xylitol.
+
+Similarly, Marchesan et al.’s study [62] assessed the associations between oral hygiene behaviors and the prevalence of dental caries, periodontal disease, and the number of lost teeth. In addition, they supported previous studies in that adult patients are recommended to use fluoride toothpaste and mouth rinses with chlorhexidine. In this study, associations between oral hygiene with variables (age, race, gender, diabetes, smoking, education, visits to the dentist, and regular sugar consumption) were found, leading to the proposal of other primary prevention measures to reduce these oral health risk factors. It recommended patients to visit the dentist more frequently and to adopt a non-cariogenic diet. The same study stated that patients with better oral hygiene and more visits had fewer cavities and teeth loss compared to those who lack oral health habits and have fewer visits to their dentist. Moreover, the study suggested that patients with daily oral hygiene habits had lower levels of periodontal disease and dental caries, as well as fewer lost teeth. It also found that a lower frequency of oral hygiene habits correlated with increased periodontal disease. Similarly, in Wagle et al.’s study [67], one of the measures to prevent dental caries was to alert patients to the frequency of sugar consumption.
+
+Meless et al. [63] conducted a study on 400 patients with a mean age of 35.5 years (± 13.1 years). The most evident dental caries preventive measure were sealants and topical fluoride application. In addition, the study demonstrated a pressing need for the presentation, planning, and implementation of primary prevention measures for oral health in the dental office and a greater awareness in the population that they should not visit their dentist only when dental pain is present. By analyzing this study [63], it was possible to infer that preventive dentistry is not the patient’s primary goal when considering a dental appointment. Accordingly, the main reasons for a dental appointment were pain (91.5%) and esthetics (23.5%). The study states that oral hygiene was insufficient in 36.8% of the patients, and there was a high prevalence of dental caries disease (98.7%).
+
+Leggett et al.’ study [64] aimed to qualitatively explore the perceived barriers and promoting factors of oral disease prevention, with a sample of adult patients who were members of the medical–dental team, members of dental committees and members of insurance companies in the UK, Denmark, Germany, the Netherlands, Ireland, and Hungary. The study showed that one of the main barriers to oral health promotion was the populations’ lack of financial capacity. This was a less problematic fact in Denmark, the Netherlands, and Germany, countries where prevention is reimbursed as provided care. Nevertheless, dentists believe this reimbursement is insufficient to implement more effective primary prevention measures. They suggested a major focus on education of the population about prevention and changing oral health behaviors, with a fairer and more equitable distribution of dental checkups. In all six countries, the need for change emerged, which implies effective joint work for more effective oral health promotion in those communities.
+
+Applying sealants was also one of the preventive measures presented by Aledhari et al. [65], as well as warning patients about the “frequency versus amount of sugar consumption”. In this study, which enrolled 59 dentists working in Baghdad, there was the assessment of the preventive orientation of Iraqi doctors, in terms of “knowledge” and “attitude” towards dental caries prevention and regarding their “preventive practice”. The results showed a significant association recorded between continuing professional education and preventive advice on dental caries in the adult population (p = 0.03).
+
+Arheiam and Bernabé [66] evaluated the attitudes and practices related to dental prevention among Libyan dentists, in addition to the recommendation of good oral hygiene and the use of fluoride toothpaste. It was also found that the preventive measures performed by dentists were the application of sealants, a preventive measure for the carious process that was transversal to the previous studies, as well as treatments with fluoride varnishes in dental pits and fissures. Sealant placement is also present in Wagle et al.’s study [67].
+
+Nishi et al. [78] aimed at appraisal of the knowledge regarding dental caries risk factors/indicators in two groups of adult patients with different socioeconomic profiles, from two culturally distinct countries (Japan and Ireland). In this study, in addition to the Irish dentists finding that patients did not periodically attend checkups and use sodium fluoride, the authors compared them to the patients of the Japanese dentists. Both groups indicated that patients did not brush their teeth properly and were unaware of the protective role of saliva on tooth decay. Moreover, the research also revealed a transversal lack of knowledge of patients regarding periodic checkups and the use of fluoride to prevent dental caries.
+
+In order to improve and maintain oral health, our results corroborated the methods of primary prevention of dental caries in adults, which can be seen in evidence found in the literature. This stated that the main strategy consisted of topical application of fluoride and sealants in pit and fissure [13,14,15,20,33]. The beneficial effect of varnishes on permanent teeth was also recognized [38], which was confirmed by Wagle et al. [67]. Petersson et al.’s [57] and Damle’s [79] studies supported that primary prevention includes topical fluorides application (fluoride gel) [80,81], fluoride varnish [80,81], fluoride oral paste [82], tooth brushing, and nutritional counselling. All decreased/excluded potential dental caries cavities and risk. The same authors also supported the promotion of dental prophylaxis, based on the encouragement/education of a correct oral hygiene and regular visits to the dentist, not only in the presence of pain, which was observed in the present review.
+
+One fact was observed in the scientific literature, which was lack of consensus about gender (of the professional staff) differences about attitudes on prevention and treatment of dental caries. Some articles pointed out that a more conservative approach was found among female dentists [83,84,85,86]. On the other hand, other studies found no statistically significant relationship between dentist gender and choices for caries prevention or treatment [87,88,89]. Further studies are necessary to clarify this issue. Other factors for recommending some type of preventive method showed that patients ≥65 years old were more likely to receive in-office fluoride. This fact depends on the dentist and their concerns about root caries prevention, which affects four out of ten adults [90]. Pentapati et al. (2019) [90] showed an estimated prevalence of 41.5% for root caries; the authors suggested the application of preventive measures focusing on policymakers and healthcare professionals could reduce the possible future burden.
+
+Furthermore, even though there is lack of literature supporting the cost-effectiveness for the use of fluorides and sealants on prevention in adult patients [91], it is possible to speculate that the patient’s interest in prevention can be more attractive than patient’s caries risk. Furthermore, Tagliaferro et al. [60] showed that only 34% of dentists were worried with the caries risk assessment. Another explanation may be that dentists are working in a person-centered care environment, employing the shared decision-making principles [92], in which the patient acts as a partner in the care delivery [93]. Further studies are necessary to evaluate these assumptions.
+
+4.3. Limitations of the Study
+
+As limitations, it is possible to refer to the limited number of articles focused on dental caries prevention in the adult patient, limited number of participants related to an extremely simple and significant disease studied, and possible correlation of this disease with other systemic problems. Furthermore, our study is an integrative review, which used a methodology to provide synthesis of knowledge and applicability of results of significant studies to practice; nevertheless, it had some limitations regarding the inclusion of studies with different variables, harming, sometimes, the comparison between studies’ data.
+
+5. Conclusions
+
+Within the limitations of this review, it was possible to conclude that the main factors and difficulties associated with the application of primary prevention strategies for dental caries in adults were not related to the dentist’s lack of knowledge, but to inadequate attention paid to the importance of preventive dentistry with their patients. This absence of primary care combined with the adult population’s lack of knowledge about this topic resulted in a higher rate of invasive treatments (dental restorations, endodontic treatments, or dental extractions). Based on the results of this review, more studies should be developed in order to check the application of primary prevention methods in other countries and populations, to provide the best information for the oral health.
+
+Author Contributions
+
+N.V., P.C. (Patrícia Couto) and P.C. (Patrícia Correia) were responsible for the conceptualization and design of the project. N.V., R.F., P.C. (Patrícia Couto) and P.C. (Patrícia Correia) were responsible for the data collection. NV and R.F. were responsible for the analysis and interpretation of data. N.V., R.F., P.C. (Patrícia Couto), P.C. (Patrícia Correia), G.V.O.F. and P.L. participated in the investigation, data curation, drafted the manuscript, and made contributions to the revising of the manuscript. All authors have read and agreed to the published version of the manuscript.
+
+Data Availability Statement
+
+The data used to generate and support the findings of this study are available from the corresponding author upon request.
+
+Conflicts of Interest
+
+The authors declare that they have no competing interests.
+
+Figure 1 PRISMA flow chart.
+
+healthcare-11-01635-t001_Table 1 Table 1 Inclusion and exclusion criteria for study selection.
+
+Selection Criteria	Inclusion Criteria	Exclusion Criteria	
+[P] Participants	People aged ≥18 years	Underage individuals	
+[I] Intervention	Primary prevention strategies for dental caries	Studies that analyze other variables	
+[C] Comparisons/context study	Not applicable	Not applicable	
+[O] Outcomes	Improving and maintaining oral health at clinical and community levels	Studies that only analyze the effect of secondary and tertiary prevention measures	
+Study design	Cross-sectional studies, exploratory cross-sectional studies, prospective cohort studies, descriptive correlational studies, randomized controlled studies, cross-sectional comparative studies, cohort studies, qualitative studies	Reviews, systematic reviews and meta-analysis, comments, expert opinion, in vivo (pre-clinical) study, in vitro study	
+Publication date	2015–2022	Before 2015	
+Languages	Portuguese, Spanish, and English	Other languages	
+Study design	Clinical study; randomized clinical trial		
+
+healthcare-11-01635-t002_Table 2 Table 2 Summary of the included studies.
+
+Authors	Title	Study Design	Participants	Objective	Findings	
+Study 1 (S1) Tagliaferro, Silva, Rosell, Junior, Riley, Gilbert, and Gordan [60]	Methods for caries prevention in adults among dentists from a Brazilian community	Cross-sectional descriptive study	Dental physicians (n = 197) reported that at least 10% of their patients were >18	To investigate the procedures used to prevent dental caries in adult patients by dental physicians in a Brazilian community	Preventive measures for dental caries in adult patients: pit and fissure sealants; fluoride application in the office, recommended use of fluoride toothpaste; chlorhexidine rinses at home; recommended use of xylitol (chewing gum, gum, toothpaste + sodium fluoride, toothpaste + sodium fluophosphate, candies, as a replacement for sucrose in the diet)	
+Study 2 (S2) Nassar, H.M. [61]	Dental Caries Preventive Considerations: Awareness of Undergraduate Dental Students	Cross-sectional study	118 dental students from Turkey	To assess dental students’ awareness and knowledge of preventive measures for dental caries in adult patients	The students indicated practical measures to prevent dental caries in patients: oral hygiene, xylitol, fluoride application in the office and its use at home, use of chlorhexidine, and dietary factors. However, 40% of the students reported formative needs and training regarding diagnosis, preventive agents of dental caries, and risk-based treatment plans. Awareness of the need for more training in risk-oriented prevention of dental caries appears to predict increased self-perceived skills and knowledge of students	
+Study 3 (S3) Marchesan, J.T., Morelli, T., Moss, K., Preisser, J.S., Zandona, A.F., Offenbacher, S., Beck, J. [62]	Interdental Cleaning Is Associated with Decreased Oral Disease Prevalence	Retrospective cohort study	Data from 6891 adult patients (≥30 years) are available from the National Health and Nutrition Examination Survey (NHANES; 2011 to 2012 and 2013 to 2014)	To evaluate the associations between oral hygiene behaviors and the prevalence of dental caries, periodontal disease, and the number of lost teeth	Patients with better oral hygiene and more visits to their dental doctor had fewer coronal caries, interproximal coronal caries, and lost teeth compared to those with fewer oral health habits and fewer visits to their dental doctor (p < 0.0001). The latter were 1.73-times (95% confidence interval, 1.53 to 1.94) more likely to have ≥ 1 coronary caries surface than those in the other group. Patients with daily oral hygiene habits, as recommended by their dentist, had lower levels of periodontal disease and dental caries, as well as fewer lost teeth. A lower frequency of oral hygiene habits correlated with increased periodontal disease. The data support fluoride toothpaste; chlorhexidine mouth rinses for oral health promotion. Considering the existence of associations between oral hygiene with age, race, gender, diabetes, smoking, education, visits to the dentist, and regular sugar consumption, it was also proposed as a primary prevention measure for the reduction of these oral health risk factors, as well as more frequent visits to the dentist and the indication of a non-cariogenic diet. These measures were assumed to be essential resources for a system with a preventive focus on oral diseases, namely dental caries	
+Study 4 (S4) Meless, G.D., Guinan, J.C., Sangaré, A.D., N’Guessan, K.S., Kouakou, K.L., Da-Danho, V., Datté, A.S., Nouaman, N.M., Amangoua, A., Samba, M., Bakayoko-Ly [63]	Oral epidemiological profile of patients attending public oral health services in Haut Sassandra region, in Côte d’Ivoire	Cross-sectional study	400 patients (51.5% male) were observed, with a mean age of 35.5 years± 13.1 years	To determine the type of care and the epidemiological profile of patients seen in the 3 public medical-dental offices in the Haut-Sassandra region of Ivory Coast	The main reasons for consultation were pain (91.5%) and aesthetics (23.5%). Oral hygiene was insufficient in 36.8% of the patients. The oral conditions were malocclusions (12.8%), dental caries (98.7%), and edentulism (65.7%), with only 11.8% of the patients having dentures. The average CPOD index (index of decayed, missing, and filled permanent teeth) was 9.3. Dental extractions and placement of fixed dentures were observed in all 3 healthcare facilities. Preventive dentistry consisted of sealants and topical application of fluoride. The most commonly performed medical acts were extractions (74.5%). The results of this study highlight the need to plan primary prevention measures for oral health in the dental office and to raise awareness among the population, who should not visit their dentist only when dental pain is present	
+Study 5 (S5)
+Leggett, H., Csikar, J., Vinall-Collier, K., Douglas, G.V.A. [64]	Whose Responsibility Is It Anyway? Exploring Barriers to Prevention of Oral Diseases across Europe	Qualitative study	58 interviews and 13 focus groups were conducted involving 149 participants from the UK, Denmark, Germany, the Netherlands, Ireland, and Hungary.
+Participants were patients (n = 50), members of the medical-dental team (n = 39), and members of dental committees (n = 33) and insurance companies (n = 27)	To qualitatively explore the perceived barriers and promoting factors of oral disease prevention from a multiple participation perspective in 6 European countries	Five themes emerged at the level of barriers and factors promoting oral health in the community: better medical-dental guidelines for increased and sustained prevention of oral diseases; patients’ knowledge and motivation to follow these guidelines; trust in dentists; sociodemographic factors. All participating countries addressed these themes; however, the differences between countries were evident in the magnitude of each theme. One of the main barriers to oral health promotion was the populations’ lack of financial capacity. However, this is less of a problem in countries such as Denmark, the Netherlands, and Germany, where prevention is reimbursed as provided care. However, dentists still feel this reimbursement is insufficient to implement more effective preventive measures. The focus with the greatest consensus was on educating the population regarding prevention and changing oral health behaviors, along with a fairer and more equitable distribution of dental vouchers, which can significantly contribute to the greater prevention of oral diseases. The results suggest that in the 6 countries, primary oral health prevention is hampered by a complex interplay of factors, with no particular oral health system offering greater patient care. The need for change has emerged, which involves more teamwork to promote oral health in communities	
+Study 6 (S6)
+Aledhari F, Sargeran K, Gholami M, Shamshiri AR [65]	Preventive Orientation of Iraqi Dentists in Baghdad in 2016	Cross-sectional study	59 dentists working in Baghdad during the
+summer of 2016	To evaluate the preventive orientation of Iraqi dentists in terms of “knowledge” and “attitude” towards dental caries prevention and explore their “preventive practice”	Of all the respondents, 71% were women. The mean age was 40.75 ± 9.88 years (range 27–65 years). The most positive attitude toward preventive dentistry was related to the question, “Preventive dentistry is essential to the community” (n = 75, 83%). Higher reported knowledge on three questions: “frequency vs. the amount of sugar consumption,” “effect of sealants in preventing dental caries,” and “effect of oral health problems on overall health” (n = 83, 92.2%). Regression analysis showed a significant association between attendance at continuing education on preventive practice (p = 0.03)	
+Study 7 (S7)
+Arheiam A, Bernabé, E. [66]	Attitudes and practices regarding preventive dentistry among Libyan dentists	Cross-sectional study	166 dental doctors practicing in Benghazi	To assess attitudes and practices related to preventive medical-dental care among Libyan dentists	The dentists mentioned that preventive dentistry is very useful and essential for preventing oral diseases in the community. As for the orientations given to patients for good oral health, the most referenced were oral hygiene recommendations to use fluoride toothpaste; the preventive measures performed by the dentists were the application of sealants and fluoride varnish treatments in dental pits and fissures	
+Study 8 (S8)
+Wagle, M., Acharya, G., Basnet, P., Trovik, T.A. [67]	Knowledge about preventive dentistry versus self-reported competence in providing preventive oral healthcare—a study among Nepalese dentists	Cross-sectional study	195 dentists (71 men and 124 women)	To describe the practices of Nepalese dentists regarding preventive education and treatment in their patients; to assess their level of knowledge about preventive oral health	More than 90% of dentists considered themselves competent in preventive treatment and oral hygiene education for their patients. Female dentists demonstrated more intervention in oral disease prevention and oral hygiene promotion than men (p = 0.045). More than 70% of the dentists had good knowledge regarding the use of fluoride as a measure to prevent dental caries, as well as good knowledge about other aspects of oral health, such as alerting patients to the frequency of sugar consumption, use of xylitol, frequent visits to the dentist, placement of sealants. The vast majority of the participating dentists revealed a high overall competence in providing preventive treatment and education for their patients regarding oral health	
+Study 9 (S9)
+Nishi, M., Harding, M., Kelleher, V., Whelton, H., Allen, F. [68]	Knowledge of caries risk factors/indicators among Japanese and Irish adult patients with different socioeconomic profiles: a cross-sectional study	Cross-sectional study	The Japanese study involved 482 patients (aged ≥20 years)
+of 52 dental practitioners in a national initiative based on the Promoting Scientific Assessment in Prevention of Tooth Decay and Gum Disease (PSAP); the Irish study involved 159 patients (aged 20–69 years) with state-provided access (‘medical record’) of medical-dental services from eight practices in County Cork	To evaluate the knowledge about dental caries risk factors/indicators in two groups of adult patients with different socioeconomic profiles from two culturally distinct countries (Japan and
+Ireland)	The higher percentage value of Irish dentists who identified that patients ‘Do not visit the dental doctor for periodic check-ups’ (OR 2.655; 99% CI 1.550, 4.547) and ‘Do not use sodium fluoride’’ (OR 1.714; 99% CI 1.049, 2.802), compared to Japanese dentists. Both studies reveal that patients ‘Do not brush their teeth properly’ is a risk factor for dental caries and that they are unaware of the buffering capacity of saliva as a protective factor for dental caries. The study reveals: a lack of knowledge in Japanese patients: in performing periodic check-ups and the use of fluoride for the prevention of dental caries; in Irish patients, lack of understanding of the buffering effect of saliva as a protective factor against dental caries. In both groups, the need to inform patients regarding the protective effect of saliva emerged	
+
+healthcare-11-01635-t003_Table 3 Table 3 JBI quality assessment.
+
+Author et al.	1	2	3	4	5	6	7	8	9	10	11	Total	%	
+Tagliaferro et al. [60]	1	1	1	0	0	1	1	1	1	1	1	9	81.81	
+Nassar [61]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Marchesan et al. [62]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Meless et al. [63]	1	1	1	0	0	1	1	1	1	1	1	9	81.81	
+Leggett et al. [64]	0	1	1	1	0	1	1	0	1	1	0	7	63.63	
+Aledhari [65]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Arheiam & Bernabé [66]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Wagle et al. [67]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Nishi et al. [68]	1	1	1	1	1	1	1	1	1	1	1	11	100	
+Values up to 50% indicates a low quality of the article; between 50 and 69% corresponds to average quality, and ≥70% reflects a high quality. (yes [1], no [0], undefined [UND], and not applicable [N/A]).
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+References
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+71. Murray J.J. Fluorides in Caries Prevention 3rd ed. Butterworth-Heinemann Oxford, UK 1991 179 208
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+73. Daly B. Watt R. Batchelor P. Treasure E. Essential Dental Public Health Oxford University Press Oxford, UK 2002
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+75. Mellberg J.R. Ripa L.W. Fluoride in Preventive Dentistry: Theory and Clinical Applications Quintessence Pub Chicago, IL, USA 1983
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+77. Walsh T. Oliveira-Neto J.M. Moore D. Chlorhexidine treatment for the prevention of dental caries in children and adolescents Cochrane Database Syst. Rev. 2015 4 CD008457 10.1002/14651858.CD008457.pub2 PMC10726983 25867816
+78. Nishi M. Harding M. Kelleher V. Whelton H. Allen F. Knowledge of caries risk factors/indicators among Japanese and Irish adult patients with different socioeconomic profiles: A cross-sectional study BMC Oral Health 2017 17 55 10.1186/s12903-017-0345-x 28209191 PMC5314636
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+93. Lee H. Chalmers N.I. Brow A. Boynes S. Monopoli M. Doherty M. Croom O. Engineer L. Person-centered care model in dentistry BMC Oral Health 2018 18 198 10.1186/s12903-018-0661-9 30497465 PMC6267887
diff --git a/corpus/healthcare/text/7b1bc80a605f1e81.txt b/corpus/healthcare/text/7b1bc80a605f1e81.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Psychol
+Journal ID: Front Psychol
+NLM Journal ID: 101550902
+Journal ID: Front. Psychol.
+
+Frontiers in Psychology
+
+EISSN: 1664-1078
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13141301
+PMID: 42094316
+DOI: 10.3389/fpsyg.2026.1852604
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Cognitive control: modeling the impact on mental health
+
+Alker Leon *
+Department of Psychology, Philipps University Marburg , Marburg , Germany
+* Correspondence: Leon Alker, leonalkersci@gmail.com
+Electronic publication date: 2026 Apr 21
+Publication date: 2026
+Volume: 17
+Electronic Location ID: 1852604
+Received 2026 Apr 10; Accepted 2026 Apr 13
+Copyright: Copyright © 2026 Alker.
+Copyright year: 2026
+Copyright holder: Alker
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Cognitive control: modeling the impact on mental health 16 21 2 2025 1452714 Frontiers in Psychology 10.3389/fpsyg.2025.1452714 PMC11885272 40062198
+Keywords: cognitive control, mental health, affective neuroscience, computational modeling, clinical neuropsychology, mind control
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 1
+
+section-at-acceptance: Cognitive Science
+
+Ÿ==============================Ÿ
+In the published article, the acronyms SONA and SoSci were incorrectly defined in Section 8.1 (Participants).
+
+The following correction has been made:
+
+“This study was carried out in accordance with relevant guidelines and regulations and was approved by the ethics committee of Philipps-University Marburg, Germany. Informed consent was obtained from all 122 participants. Ninety-five participants were students, 27 of whom were employees of a university hospital. Students were recruited via the SONA first-year practicum and were then forwarded to the online survey platform SoSci Survey for study participation. SONA is an online participant management system used to recruit and schedule student participants, typically in exchange for course credit. SoSci Survey is an online survey platform used to administer questionnaires and collect data.”
+
+The original version of this article has been updated.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
diff --git a/corpus/healthcare/text/7bf69ebad100545e.txt b/corpus/healthcare/text/7bf69ebad100545e.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Yearb Med Inform
+Journal ID: Yearb Med Inform
+NLM Journal ID: 9312666
+
+Yearbook of Medical Informatics
+
+ISSN: 0943-4747
+EISSN: 2364-0502
+Publisher: Thieme Medical Publishers
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12020551
+PMID: 40199305
+DOI: 10.1055/s-0044-1800742
+Article ID: Bloomrosen
+Article version: 1
+Subjects: Section 7: Health Information Exchange, Synopsis
+
+Health Information Exchange: Contributions from 2023
+
+Bloomrosen Meryl 1
+Feldman Sue S. 2 3
+1 American Medical Association, Chicago, IL, USA
+2 Graduate Programs in Health Informatics, Department of Health Services Administration, University of Alabama at Birmingham, Birmingham, AL, USA
+3 Department of Biomedical Informatics and Data Science, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA
+Correspondence to: Meryl Bloomrosen meryl.bloomrosen@ama-assn.org
+Electronic publication date: 2025 Apr 8
+Publication date: 2024 Aug
+Volume: 33
+Issue: 1
+First page: 191
+Last page: 194
+
+Copyright: The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. ( https://creativecommons.org/licenses/by/4.0/ )
+Copyright year: 2024
+Copyright holder: The Author(s).
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: International Medical Informatics Association Yearbook, Health Information Exchange, Health Information, Interoperability, Data Sharing, Health Information Technology, Electronic Health Records
+
+Ÿ==============================Ÿ
+Summary
+
+Objectives : To summarize the recent literature and research and present a selection of the best papers published online and in print in 2023 related to health information exchange (HIE).
+
+Methods : Using Covidence as a screening and analysis tool, a systematic review of the literature was independently conducted by the two section editors. Seven studies emerged as suitable for final IMIA Yearbook consideration.
+
+Results : Among the papers reviewed, three major themes emerged: clinical services utilization, continuity of care, and public and population health. These themes represent an increased breadth and depth of HIE application.
+
+Conclusions : Review of the literature suggested more studies with the use of data from HIEs, perhaps suggesting increased trust in data accuracy, adequacy, and completeness. The section editors noted the increase in papers from diverse countries describing applications of HIEs suggesting more widespread implementation of HIEs worldwide. As health data standards are developed and adopted globally, this could set the stage for increased international health data exchange. The larger corpus of 2023 literature reviewed resulted in conversations by the section editors on the changing landscape of the expanding, maturing, and innovative use cases for HIEs and HIE data. This landscape bears continued watching in 2024.
+
+1. Introduction
+
+Health Information Exchange (HIE) refers to the electronic sharing of a broad range of health-related information among different healthcare organizations and often disparate systems [ 1 , 2 ]. This process of information sharing, which can be facilitated by an organization called an HIE, aims to facilitate access to and retrieval of clinical data to provide safer, more timely, efficient, effective, and equitable patient-centered care [ 1 , 3 4 5 ]. By enabling the seamless exchange of medical information, HIEs can help to reduce the duplication of tests, minimize treatment delays, and enhance clinical decision-making [ 1 , 3 4 5 ]. Furthermore, HIEs can play a crucial role in public health by improving the ability to track and manage diseases and conditions across populations. As healthcare continues to evolve in the digital age, HIEs are becoming increasingly vital in ensuring that healthcare providers have the information they need to deliver high-quality care.
+
+Globally, nations have adopted various approaches and levels of HIE. Country-specific legislative and regulatory policy impacts HIE implementation and governance. There are differences in data collected, governance, scope, financing, levels of data sharing, technical and technological infrastructure, maturity and public policy considerations [ 6 7 8 9 ].
+
+There are several ways to categorize HIE when discussing how HIE contributes to a more connected and efficient health care system to enhance the quality of care, lower the cost of care, and increase care continuity. For example, there are depictions of “types” of exchange: 1) directed exchange, which allows the secure exchange of health-related information between health providers [ 10 ], 2) query-based exchange, which allows providers to search for and retrieve health-related information on specific people for a specific treatment [ 11 ], and 3) consumer-mediated exchange, which puts the patient at the center of the access, management, and sharing of health-related information [ 12 ]. While various forms of these HIEs exist globally, depending on maturity, each of these types of HIE can co-exist in the same technological environment and include the same types of data, but they are more likely to exist in different technical environments that have expanded the traditional definition of an HIE and include different types of data with increased specificity, depending on the use and user. Whereas the traditional perspective of HIE was focused around provider generated exchange (directed exchange and query-based exchange), HIEs are grappling with how to accommodate consumer-mediated exchange [ 12 ]. For example, the survey paper by Dullabh et al. illustrates two different mechanisms for consumer-mediated exchange to occur [ 13 ]. It is important to note that, regardless of the mechanism, consumer-mediated exchange involves more than who can see and use what health-related data. Consumer-mediated exchange can also include consumer-generated data, such as that from implantables and wearables. Data from implantables, for example a pacemaker, has an element of data control and therefore may be more trusted than data from wearables, such as a fitness watch [ 14 ]. Wearables are often controlled by external applications with application programming interfaces (APIs) allowing for information to be sent to or accessed by a third party, and because of this third party, consumer-generated data from wearables, while important and accurate may not share the same level of trust as that from implantables.
+
+The 2023 articles that were reviewed showed a greater focus on the use of data from HIEs to conduct research and analysis rather than the actual use of the HIE to impact care . While the use of data from HIEs to conduct and inform research was not the focus of the final paper selections, this shift could suggest that researchers increasingly believe that the data from HIEs is accurate, adequate, and complete enough to draw conclusions worthy of integration into a learning health system or knowledge health system. We also noted more papers describing the use of HIEs from diverse countries, suggesting that HIE use is maturing worldwide. Global efforts are underway to develop and adopt the International Patient Summary 1 , which is a set of basic patient level, clinical data for use in the case of an unexpected or unscheduled medical situation (e.g. emergency or accident). While this does not suggest any level of interoperability to facilitate global exchange of health-related information, it is encouraging that the potential may exist.
+
+2. About the paper Selection
+
+In February 2024, with the assistance of a medical librarian, the co-editors conducted a PubMed and Embase search using MeSH headings, keywords, and synonyms in titles and abstracts with a focus on HIE. The publication year included first online and print publications between January 1, 2023 and December 31, 2023, inclusive. The search strategy is shown in Table 1 .
+
+Table 1. Search Strategy
+
+PubMed		Embase	
+(“Health Information Exchange”[Majr] OR Health-Information-Exchange*[Title/Abstract] OR Medical-Information-Exchange*[Title/Abstract] OR Clinical-information-system* OR clinical-pharmacy-information-system*[Title/Abstract] OR health-information-network*[Title/Abstract] OR health-information-system*[Title/Abstract] OR medical-information-service*[Title/Abstract] OR is-h-med[Title/Abstract]) AND (“2023/01/01”[Date - Publication] : “2023/12/31”[Date - Publication])		‘(‘medical information system'/exp/mj OR ‘health information exchange*’:ab,ti OR ‘medical information exchange*’:ab,ti OR ‘clinical-information-system*or clinical-pharmacy-information-system*’:ab,ti OR ‘health information network*’:ab,ti OR ‘health information system*’:ab,ti OR ‘medical information service*’:ab,ti OR ‘is h med’:ab,ti) AND [2023-2023]/py AND (‘article’/it OR ‘article in press’/it OR ‘review’/it)	
+
+All studies were imported into EndNote ® for first round deduplication. The remaining studies were imported into Covidence 2 for further deduplication, screening, and analysis. Each of the two section editors independently screened 752 studies. Inclusion differences were reconciled through conversation and then by eventual mutual agreement between the section editors. Of the 12 studies for consideration, five were excluded, resulting in seven studies for final IMIA Yearbook consideration ( Figure 1 ).
+
+Figure 1. PRISMA diagram of literature search (Generated from Covidence.org)
+
+A content summary of the best papers ( Table 2 ) can be found in the appendix of this synopsis.
+
+Table 2. Selection of best papers for the 2024 IMIA Yearbook of Medical Informatics for the section Health Information Exchange. The articles are listed in alphabetical order of the first author's surname.
+
+Section Health Information Exchange	
+Aniekwe C, Cuffe K, Audu I, Nalda N, Ibezim B, Nnakwe M, Anazodo T, Dada M, Romano ER, Okoye M, Martin M. Assessing the effect of electronic health information exchange on the completeness and validity of data for measuring viral load testing turnaround time in Nigeria. International Journal of Medical Informatics. 2023 Jun 1;174:105059. https://doi.org/10.1016/j.ijmedinf.2023.105059
+Sloan-Aagard C, Glenn J, Nañez J, Crawford SB, Currey JC, Hartmann E. The impact of community health information exchange usage on time to reutilization of hospital services. The Annals of Family Medicine. 2023 Jan 1;21(1):19-26. https://doi.org/10.1370/afm.2903	
+
+3. Outlook
+
+The seven candidate best papers for 2023 reflected an increase in international HIE usage and more attention to the validity of the data retrieved through an HIE. The use of HIE for public health purposes was noted as a cross-cutting domain where innovative uses of HIE were recognized. Below, we discuss the major themes of the seven papers from 2023 that were candidates for being selected as a “Best Paper for 2024 Yearbook HIE Section”.
+
+3.1 Clinical Services Utilization
+
+Three of the seven studies examined the use of an HIE to impact clinical services utilization. A study by Adler-Milstein et al. used secondary data sets to identify HIE participation and then looked at the impact of HIE participation on repeat imaging and hospital admission. This study found that HIE participation was not associated with decreased repeat imaging [ 15 ]]. The authors report on hospital admission in terms of admission following a treat-and-release emergency department (ED) visit, which was associated with a lower likelihood of hospital admission and admission following discharge, which was associated with a higher likelihood of admission. A second study examined the availability of patient information and the impact on repeat diagnostics, primarily in oncology patients in The Netherlands [ 16 ]. This study showed that diagnostics were repeated unnecessarily in 15.8% of the study sample. The last of these three studies, by Sloan-Aagard et al. , one of the two papers selected as a best paper for the 2024 Yearbook, is one of a few studies that looks at clinical services utilization with HIE use of community primary care physicians [ 17 ]. Often referred to as the “white space” of electronic health record adoption and subsequent HIE connectivity, community-based primary care was largely ignored in the early days of United States (US) regulations incentivizing health data collection, exchange and reporting. As such, there was little motivation for community physicians to be HIE participants. The study by Soan-Aagard et al. suggested that querying the HIE had a statistically significant association with reducing ED visits by 53% and a rehospitalization reduction by 61%. It further showed that HIE querying was associated with an increased median time to use ED services. This study is presented in more detail in the appendices of this synopsis.
+
+3.2 Continuity of Care
+
+There have been a number of efforts to associate the use of HIE in contributing to care continuity, especially in the mental health space and other chronic care conditions where patients are often “lost” during hand offs [ 18 19 20 ]. As such, this study by Itzhaki et al. , details the criticality of HIE awareness among all stakeholders prior to HIE-facilitated information sharing [ 21 ]. While the findings from this study are not new and have been articulated by others [ 22 ], this study is set in Israel where HIEs are less mature than as compared to that in the US and further illustrates global HIE implementation and use.
+
+3.3 Public and Population Health
+
+Three of the seven studies considered for the IMIA Yearbook cut across HIE and public or population health illustrating a greater use of HIE in this domain. The first study, conducted by Feldman et al. (no relation to the co-editor), examined a partnership between Maryland's HIE, Chesapeake Regional Information System for Our Patients (CRISP), and the Maryland Department of Health to use CRISP as a transport vehicle for positive COVID-19 test results [ 23 ]. The use of CRISP as a transport vehicle facilitated more accurate patient matching and more expeditious contact tracing efforts. While there are other studies detailing the value of near real-time data transmission of COVID-19 test results [ 24 , 25 ], the innovative use of CRISP to do so made a valuable contribution to the HIE literature for public health uses and demonstrated a real-world use case that could prove beneficial in future times of widespread communicable disease situations.
+
+Another innovative use case of HIE for public and population health was for refugees as they entered a military camp in the US (Indiana) from Afghanistan. What made this study unique was the fact that 50% of the 6600 refugees were under 18 years, necessitating an expansion in the traditional public health focus to pediatrics [ 26 ]. This was further complicated by a concurrent surge in COVID-19 cases in Indiana, making this use case one of population and public health significance. A centralized refugee inbox was created to facilitate expeditious and secure communications between providers. Additionally, the creation of a primary care identifier that was linked to the camp address, allowed for refugees to have a temporary, yet primary medical home for health data exchange and secure communications, resulting in almost 2700 messages during the 20-week study period. Of those 2700 messages, almost 73% were exchanged with the Children's Hospital. Across all messages, 56% were ED related. It was a bit surprising that only 23% of the messages were related to laboratory and radiology messages. This study illustrated the utility for leveraging existing partnerships and a robust HIE to provide healthcare services for a transient or temporary population.
+
+The last paper to be considered for the IMIA Yearbook, was conducted in Nigeria, and highlighted the effect of data completeness of HIE data on HIV viral load testing turnaround times. This study suggested that data completeness increased from 47% pre-HIE implementation to 67% 6-months post-HIE implementation [ 27 ]. This study was selected for inclusion in the IMIA Yearbook and is therefore presented in more detail in the appendices.
+
+4. Conclusion
+
+Studies on HIE published in 2023, of which seven are summarized here, suggested increased breadth and depth in the use of data from HIEs and the use of HIEs to impact clinical services utilization, continuity of care, and public and population health. The HIE section editors' note that can be viewed as a follow on to finding from the 2023 IMIA Yearbook showing HIE being used in more diverse settings [ 3 ]. It is further noted that these studies set the stage for more innovation around the use of HIEs as a transport mechanism to improve care across a variety of unconventional settings. The survey paper also sets the stage for better integration of HIEs and consumer-mediated HIE and represents an area ripe for more research in this area, especially in the use of consumer-generated health information in clinical decision-making.
+
+Acknowledgements
+
+We would like to acknowledge the reviewers in the selection process of the IMIA Yearbook studies. The HIE section editors also acknowledge the valuable work of Megan Bell, the medical librarian at UAB who provided the corpus of literature for screening and analysis.
+
+1 https://international-patient-summary.net/
+
+2 https://www.covidence.org
+
+
+References
+
+1 Middleton B, editor The Value of Healthcare Information Exchange and Interoperability. Healthcare Information Management Systems Society (HIMSS); 2004 2/22-26/2004; Orlando, FL.
+2 Brailer DJ. Interoperability: The Key To The Future Health Care System. Health Affairs. 2005;24(Suppl1):W5-19-W5-21.10.1377/hlthaff.w5.19 15659454
+3 Bloomrosen M, Berner ES. Findings from the 2023 Yearbook Section on Health Information Exchange. Yearbook of Medical Informatics. 2023;32(01):195-200. doi: 10.1055/s-0043-1768755.10.1055/s-0043-1768755 PMC10751133 38147861
+4 Kaelber DC, Bates DW. Health information exchange and patient safety. Journal of Biomedical Informatics. 2007;40(6 Suppl):S40-S5. doi: 10.1016/j.jbi.2007.08.011.10.1016/j.jbi.2007.08.011 17950041
+5 Feldman SS, Schooley BL, Bhavsar GP. Health Information Exchange Implementation: Lessons Learned and Critical Success Factors From a Case Study. JMIR Medical Informatics. 2014;2(2):e19. doi: 10.2196/medinform.3455.10.2196/medinform.3455 PMC4288070 25599991
+6 Payne TH, Lovis C, Gutteridge C, Pagliari C, Natarajan S, Yong C, et al. Status of health information exchange: a comparison of six countries. J Glob Health. 2019;9(2). doi: 10.7189/Fjogh.09.020427.10.7189/jogh.09.020427 PMC6815656 31673351
+7 Vest JR. Health information exchange: national and international approaches. Health Information Technology in the International Context. 2012;12:3-24. doi: 10.1108/s1474-8231(2012)0000012005.10.1108/s1474-8231(2012)0000012005 22894043
+8 Vest JR, Kash BA. Differing strategies to meet information-sharing needs: publicly supported community health information exchanges versus health systems' enterprise health information exchanges. The Milbank Quarterly. 2016;94(1):77-108. doi: 10.1111/1468-0009.12180.10.1111/1468-0009.12180 PMC4941963 26994710
+9 Akhlaq A, McKinstry B, Muhammad KB, Sheikh A. Barriers and facilitators to health information exchange in low-and middle-income country settings: a systematic review. Health policy and planning. 2016;31(9):1310-25. doi: 10.1055/s-0043-1768719.10.1093/heapol/czw056 27185528
+10 Thurman AK, Dixon BE, Kibbe DC, Pan E, Feldman SS. Use of the Direct Standard for Patient Event Notifications: A Qualitative Study Among Industry Leaders. Applied Clinical Informatics Open. 2023;07(02):e91-e8. doi: 10.1055/s-0043-1776326.
+11 Dixon BE. Introduction to health information exchange. Health Information Exchange: Elsevier; 2023. p. 3-20.
+12 Esmaeilzadeh P, Dharanikota S, Mirzaei T. The role of patient engagement in patient-centric health information exchange (HIE) initiatives: An empirical study in the United States. Information Technology & People. 2024;37(2):521-52. doi:10.1108/ITP-05-2020-0316
+13 Dullabh P, Dhopeshwarkar R, Desai PJ. New Horizons for Consumer-Mediated Health Information Exchange. Yearb Medical Inform. 2024;179-190. doi: 10.1055/s-0044-180074110.1055/s-0044-1800741 PMC12020518 40199304
+14 Hederman L, Berry D, Ormazabal A, editors. Clinician's perspective on trusting Patient Generated Health Data for use in clinical decision-making: A qualitative interview study. 2023 IEEE 36th International Symposium on Computer-Based Medical Systems (CBMS); 2023: IEEE.
+15 Adler-Milstein J, Linden A, Hsia RY, Everson J. Electronic connectivity between hospital pairs: impact on emergency department-related utilization. Journal of the American Medical Informatics Association. 2024;31(1):15-23. doi: 10.1093/jamia/ocad204.10.1093/jamia/ocad204 PMC10746309 37846192
+16 De Swart ME, Zonderhuis BM, Hellingman T, Kuiper BI, Dickhoff C, Heineman DJ, et al. Incomplete patient information exchange and unnecessary repeat diagnostics during oncological referrals in the Netherlands: exploring the role of information exchange. Health Informatics Journal. 2023;29(1):14604582231153795. doi: 10.1177/14604582231153795.10.1177/14604582231153795 36708072
+17 Sloan-Aagard C, Glenn J, Nañez J, Crawford SB, Currey J, Hartmann E. The impact of community health information exchange usage on time to reutilization of hospital services. The Annals of Family Medicine. 2023;21(1):19-26. doi: 10.1370/afm.2903.10.1370/afm.2903 PMC9870640 36690494
+18 Abraham J, Kannampallil TG, Patel VL. Bridging gaps in handoffs: a continuity of care based approach. Journal of Biomedical Informatics. 2012;45(2):240-54. doi: 10.1016/j.jbi.2011.10.011.10.1016/j.jbi.2011.10.011 22094355
+19 Unertl KM, Johnson KB, Lorenzi NM. Health information exchange technology on the front lines of healthcare: workflow factors and patterns of use. Journal of the American Medical Informatics Association. 2012;19(3):392-400. doi: 10.1136/amiajnl-2011-000432;10.1136/amiajnl-2011-000432 PMC3341790 22003156
+20 Guerrazzi C, Feldman SS. Health information exchange: What matters at the organizational level? Journal of Biomedical Informatics. 2020;102:103375. doi: 10.1016/j.jbi.2020.103375.10.1016/j.jbi.2020.103375 31931168
+21 Itzhaki M, Koren E, Hussein KA, Levy L, Gantz I, Barnoy S. Use of Health Information Exchange in the Continuity of Care as Viewed by Patients and Nurses: A Cross-Sectional Study. Computers, Informatics, Nursing. 2023;41(1):39-45. doi: 10.21203/rs.3.rs-72163/v1.10.1097/CIN.0000000000000861 35363630
+22 Feldman SS, Bhavsar GP, Schooley BL. Consumer perceptions of health IT utilization and benefits. JAMIA Open. 2018;2(1):99-106. doi: 10.1093/jamiaopen/ooy049.10.1093/jamiaopen/ooy049 PMC6951931 31984349
+23 Feldman KA, Hanks A, Williams TW, Blouse B, Babcock C, Goode A, et al. A state health department and health information exchange partnership: An effective collaboration for a data-driven response for COVID-19 contact tracing in Maryland. Sexually transmitted diseases. 2023;50(8S):S34-S40.10.1097/OLQ.0000000000001702 PMC9992453 36098564
+24 Feldman SS, Ahmed A, Maxwell J, Schooley B. Evaluation of a COVID-19 Risk Tool. Studies in health technology and informatics. 2024;310:1552-3. doi: 10.3233/SHTI231289.10.3233/SHTI231289 38269741
+25 Schooley BL, Ahmed A, Maxwell J, Feldman SS. Predictors of COVID-19 From a Statewide Digital Symptom and Risk Assessment Tool: Cross-Sectional Study. Journal of medical Internet research. 2023;25:e46026. doi: 10.2196/46026.10.2196/46026 PMC10410382 37490320
+26 Webber EC, Peterson RJ, Lory K, Kanis J, Saysana M, Schneider KS. A unique use of regional information exchange by a statewide health system serving refugees:“Operation Allies Welcome”. Applied Clinical Informatics. 2023;14(03):487-93. doi: 10.1055/a-2072-9629.10.1055/a-2072-9629 PMC10306977 37054982
+27 Aniekwe C, Cuffe K, Audu I, Nalda N, Ibezim B, Nnakwe M, et al. Assessing the effect of electronic health information exchange on the completeness and validity of data for measuring viral load testing turnaround time in Nigeria. International Journal of Medical Informatics. 2023;174:105059. doi: 10.1016/j.ijmedinf.2023.105059.10.1016/j.ijmedinf.2023.105059 PMC11187829 37002987
diff --git a/corpus/healthcare/text/80c29c8d320a88a7.txt b/corpus/healthcare/text/80c29c8d320a88a7.txt
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@@ -0,0 +1,610 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Rev Esc Enferm USP
+Journal ID: Rev Esc Enferm USP
+NLM Journal ID: 0242726
+Journal ID: reeusp
+
+Revista da Escola de Enfermagem da USP
+
+ISSN: 0080-6234
+EISSN: 1980-220X
+Publisher: Escola de Enfermagem da Universidade de São Paulo
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11321456
+PMID: 39136682
+DOI: 10.1590/1980-220X-REEUSP-2024-0116en
+Article ID: 00809
+Article version: 1
+Subjects: Review
+
+Nursing care for women with HELLP syndrome: a scoping review
+
+Cuidados de enfermagem a mulheres com síndrome HELLP: scoping review Atención de enfermería a mujeres con síndrome HELLP: revisión del alcance
+
+https://orcid.org/0009-0002-3566-0634 Arduini Pâmela Silva 1
+https://orcid.org/0000-0003-1203-2504 de Resende Cynthya Viana 1
+https://orcid.org/0000-0002-4308-5978 da Silva Jéssica Aparecida 1
+https://orcid.org/0000-0002-5199-7328 Ruiz Mariana Torreglosa 2
+1 Universidade Federal do Triângulo Mineiro, Uberaba, MG, Brazil.
+2 Universidade Federal do Triângulo Mineiro, Programa de Pós-Graduação em Atenção à Saúde, Uberaba, MG, Brazil.
+Corresponding author: Mariana Torreglosa Ruiz, Praça Manoel Terra, 330, Centro, 38025-015 – Uberaba, MG, Brazil, mariana.ruiz@uftm.edu.br ASSOCIATE EDITOR: Rebeca Nunes Guedes de Oliveira
+
+Electronic publication date: 2024 Aug 12
+Publication date: 2024
+Volume: 58
+Electronic Location ID: e20240116
+Received 2024 Apr 19; Accepted 2024 Jun 27
+License: This is an Open Access article distributed under the terms of the Creative Commons Attribution License.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: HELLP Syndrome, Nursing Care, Obstetric Nursing
+Keywords: Síndrome HELLP, Atención de Enfermería, Enfermería Obstétrica
+Figure count: 02
+Table count: 06
+Reference count: 40
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Objective:
+
+To map evidence on nursing care for women with HELLP syndrome.
+
+Method:
+
+A scoping review with searches carried out in May 2023, independently, in the PubMed/MEDLINE, LILACS, Scopus, EMBASE, Web of Science, CINAHL, CAPES Theses and Dissertations Catalog and Cochrane Library databases, correlating the descriptors HELLP Syndrome, Nursing Care and Obstetric Nursing and its synonyms, without delimitation of time and language. Selection was carried out by three researchers independently and resolved by consensus.
+
+Results:
+
+Of the 129 studies, ten were selected, which made up the final sample. The studies date from 2004 to 2022, with a predominance of English language and clinical case studies. A greater occurrence of the syndrome was observed in second-time pregnant women in the second decade of life, with a gestational age from 32 weeks, which resulted in an emergency cesarean section, and all newborns were discharged accompanied by their mothers. Studies that described nursing diagnoses and focused on nursing care were retrieved. From the review, 39 nursing care were identified.
+
+Conclusion:
+
+This review pointed out the magnitude of the syndrome, however with a lack of studies.
+
+RESUMEN
+
+Objetivo:
+
+Mapear evidencia sobre los cuidados de enfermería a mujeres con síndrome HELLP.
+
+Método:
+
+Revisión de alcance, con búsquedas realizadas en mayo de 2023, de forma independiente, en las bases de datos PubMed/MEDLINE, LILACS, Scopus, EMBASE, Web of Science, CINAHL, Catálogo de Tesis y Disertaciones CAPES y Cochrane Library, correlacionando los descriptores HELLP Syndrome, Nursing Care y Obstetric Nursing y sus sinónimos, sin delimitación de tiempo e idioma. La selección fue realizada por tres investigadores de forma independiente y resuelta por consenso.
+
+Resultados:
+
+De las 129 publicaciones se seleccionaron diez, que conformaron la muestra final. Las publicaciones datan de 2004 a 2022, con predominio del inglés y estudios de casos clínicos. Se observó una mayor ocurrencia del síndrome en mujeres embarazadas por segunda vez en la segunda década de la vida, con edad gestacional a partir de las 32 semanas, lo que resultó en cesárea de emergencia, y todos los recién nacidos fueron dados de alta acompañados de sus madres. Se recuperaron estudios que describían diagnósticos de enfermería y se centraban en los cuidados de enfermería. De la revisión se identificaron 39 medidas de cuidados de enfermería.
+
+Conclusión:
+
+Esta revisión señaló la magnitud del síndrome, aunque faltan estudios.
+
+INTRODUCTION
+
+According to the World Health Organization (WHO), hypertensive syndromes during pregnancy account for one-tenth of maternal deaths(1). On the national scene, data from the Brazilian Health System Department of Informatics (DATASUS – Departamento de Informática do Sistema Único de Saúde) indicate that, between 1996 and 2021, more than 45 thousand maternal deaths and 2,808 late deaths were recorded, totaling 48,301 maternal deaths. Of these, 62% were due to direct obstetric causes, and hypertensive syndromes accounted for 34.4% of all causes (16,622 deaths), with eclampsia being the first reason for maternal death in the country(2).
+
+A review of Brazilian studies on pre-eclampsia and eclampsia found a frequency of pre-eclampsia of 6.7%, and of eclampsia, between 1.7% and 6.2%, and HELLP syndrome represented the evolution of one in every 30 cases of pre-eclampsia, being a condition little reported, although it represents a greater severity of the evolution of the conditions(3).
+
+Pre-eclampsia is characterized by an increase in blood pressure after the twentieth week of pregnancy associated with proteinuria, which can be resolved after birth or evolve with complications and sequels. Eclampsia, on the other hand, consists of a condition that involves seizures not attributed to neurological causes in patients with a previous diagnosis of pre-eclampsia, being classified as a complication of pre-eclampsia. HELLP syndrome is a worsening of pre-eclampsia, progressing with hemolysis, elevated liver enzymes and severe thrombocytopenia, being considered the most severe evolution of gestational hypertensive syndromes(4,5).
+
+Increased blood pressure during pregnancy is considered to be values of systolic blood pressure (SBP) greater than or equal to 140 mmHg and/or diastolic blood pressure (DBP) greater than or equal to 90 mmHg, measured using an appropriate technique and confirmed by two measurements spaced four hours apart. If a SBP value greater than 160 mmHg and/or a DBP greater than 110 mmHg is obtained, a new measurement is recommended within 15 minutes and, if values are maintained, start treatment immediately. Proteinuria is laboratory confirmed by the presence of 300 mg or more of protein in 24-hour urine or a result of a urinary protein/creatinine ratio equal to or greater than 0.3, or if it is not possible to perform a 24-hour test, the presence of at least one cross in an isolated urine sample(4,5).
+
+The first description of HELLP syndrome dates back to 1982 by doctor Louis Weinstein(6), who observed the emergence of symptoms from 20 weeks of gestation onwards as well as its first manifestations in the postpartum period. The syndrome’s common symptoms include sudden malaise, nausea and vomiting, and abrupt and intense abdominal pain in the right upper quadrant of the abdomen and/or epigastric quadrant, with pain being the characteristic symptom of the syndrome. Generally, the condition is associated with the complication of pre-eclampsia(7); however, in 15% to 20% of cases, they may occur without hypertensive increase or without proteinuria(8).
+
+To conclude the diagnosis, laboratory tests are necessary, consisting of the following criteria: 1. Hemolysis (abnormal smear suggestive of microangiopathic hemolytic anemia characterized by the presence of schistocytes); 2. Total bilirubin above 1.2 mg/dl; 3. Lactate dehydrogenase above 6,000 U/l or hepatoglobin lower than the lower limit for normality; 4. Hepatic enzyme alanine aminotransferase with a value twice the normal limit; and 5. Platelet count less than 100,000/μl. Of these criteria, the presence of one to two suggests the possibility of HELLP, and three criteria define the diagnosis(9).
+
+Among the possible complications of the syndrome, pulmonary edema, reversible or non-reversible kidney damage, need for polytransfusions, admission to an Critical Care Unit (CCU) and disseminated intravascular coagulation are common(8,9), which makes cases more serious.
+
+HELLP syndrome is characterized as a serious and acute condition, consisting of an obstetric emergency. It affects one woman for every 45,000 live births, accounting for 0.1% to 0.9% of complications during the pregnancy-puerperal cycle, with 10% to 30% of cases presenting as a complication of pre-eclampsia(7). Around 45% of HELLP cases progress seriously(10). All cases require intensive care, and 1% progress to liver rupture(11), a condition that poses a risk of mortality, especially when platelets reach levels below 50,000(10,11).
+
+In most cases, the etiopathogenesis is unknown. However, null or multiparity, age over 30 years, history of HELLP syndrome in a previous pregnancy, chronic hypertension, diabetes diagnosed pre-gestation, heart disease, obesity, chronic liver diseases, placental changes and congenital abnormalities are described as risk factors for HELLP syndrome(12).
+
+In addition to the negative impact and possible complications in women’s lives(13,14), hypertensive syndromes in the pregnancy-puerperal period are associated with prematurity, and this is the main cause of death in children under five years of age(15).
+
+Quality prenatal care is a protective factor against complications of the syndrome, which, although it cannot be prevented, the earlier the diagnosis is made, the greater the possibility of reducing damage. Termination of pregnancy is indicated as treatment as soon as the condition is stabilized, that is, it should not be untimely or immediate, but planned to avoid negative outcomes(5). Thus, due to its complexity and high potential for complications, the importance of qualified nursing care based on scientific evidence is identified.
+
+This research aims to present a synthesis of knowledge about nursing care for women with HELLP syndrome, in a way that allows nurses to make safe and accurate decisions based on previous results described in the literature. Considering the above, this study aimed to map evidence on nursing care for women with HELLP syndrome.
+
+METHOD
+
+Study Design
+
+This is a scoping review developed based on JBI recommendations(16). In this way, the steps were taken: (1) establishment of title and review question based on the PCC mnemonic, where P: Population, C: Concept and C: Context; (2) exploration of the state of the art of the research problem with writing of review introduction; (3) inclusion criteria definition; (4) search strategy design (sources, descriptors and manual references based on reading selected studies); (5) selection of source of evidence (examiner and protocol); (6) article selection – process guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA-ScR) flowchart(17); (7) data extraction; (8) analysis of evidence; and (9) presentation of results in tabular form and through descriptive mapping. Protocol was registered in the Open Science Framework (https://osf.io/d8kup).
+
+Search Strategy
+
+To prepare the review question, the PCC mnemonic was used, with Population (P) including pregnant or postpartum women, Concept (C) including nursing care, and Context (C) including HELLP syndrome. Therefore, the review question was: what is the evidence on nursing care for women with HELLP syndrome?
+
+The searches were carried out in May 2023, independently, by two reviewers, a master’s student and a doctor. One reviewer has experience with search strategy and training courses for scoping reviews, and both are experts in the area of maternal and child health. The search was validated by a librarian. The descriptors HELLP Syndrome, Nursing Care and Obstetric Nursing were used. The US National Library of Medicine National Institutes of Health (MEDLINE/PubMed), Web of Science (WoS), Excerpta Medica DataBASE (EMBASE), SciVerse Scopus, Latin American and Caribbean Literature in Health Sciences (LILACS), CAPES Theses and Dissertations Catalog and Cochrane Library databases were selected for consultation, correlating the descriptors HELLP Syndrome, Nursing Care and Obstetric Nursing. No date, language and/or study design filters were applied. The search strategies are described in Chart 1, with the numerical return obtained.
+
+Chart 1 Database search strategies and numerical return obtained – Uberaba, MG, Brazil, 2023.
+
+Database	Search strategy	n	
+PubMed	(((“HELLP Syndrome” [Mesh] OR Syndrome, HELLP OR Hemolysis, Elevated Liver Enzymes, Lowered Platelets) AND (“Nursing Care”[Mesh] OR Care, Nursing OR Management, Nursing Care OR Nursing Care Management OR “Obstetric Nursing” [Mesh] OR Nursing, Obstetric OR Nursings, Obstetric OR Obstetric Nursings OR Nursing, Obstetrical OR Nursings, Obstetrical OR Obstetrical Nursings OR Obstetrical Nursing)	25	
+EMBASE	(‘HELLP Syndrome’/exp OR ‘HELLP (hemolysis, elevated liver enzymes and low platelets) syndrome’ OR ‘hemolysis, elevated liver enzymes, and low platelet count syndrome’ OR ‘hemolysis, elevated liver enzymes, and low platelets syndrome’ OR ‘hemolysis, elevated liver enzymes, low platelet count syndrome’ OR ‘syndrome HELLP’ OR ‘HELLP syndrome’) AND (‘Obstetrical nursing’/exp OR ‘obstetric nursing’ OR ‘obstetrics nursing’ OR ‘obstetrical nursing’ OR ‘Nursing’/exp OR ‘hospital nursing service’ OR ‘nursing service’ OR ‘nursing service, hospital’ OR ‘nursing services’ OR ‘nursing support’ OR ‘nursing, private duty’ OR ‘nursing, supervisory’ OR ‘office nursing’ OR ‘private duty nursing’ OR ‘supervisory nursing’ OR ‘nursing’) AND [embase]/lim NOT ([embase]/lim AND [medline]/lim)	28	
+Scopus	ALL (“HELLP Syndrome”) AND TITLE-ABS-KEY (*nursing AND care* OR *obstetric AND nursing* )	54	
+WoS	(ALL=(HELLP syndrome*)) AND ALL=(Nursing care*) AND (ALL=(HELLP syndrome*)) AND ALL=(obstetric nursing*)	27	
+LILACS	(tw:(“Síndrome HELLP” OR “HELLP Syndrome” OR “HELLP syndrome” OR C12.050.703.395.186 )) AND (tw:(“Cuidados de Enfermagem” OR “Nursing Care” OR “Atención de Enfermería” OR “Soins infirmiers” OR “Assistência de Enfermagem” OR “Atendimento de Enfermagem” OR “Cuidado de Enfermagem” OR “Gestão da Assistência de Enfermagem” OR “Sistematização da Assistência de Enfermagem” OR “E02.760.611” “OR N02.421.533” OR “Enfermagem Obstétrica” OR “Obstetric Nursing” OR “Enfermería Obstétrica” OR “Soins infirmiers em obstétrique” OR “H02.478.676.570” OR “N02.421.533.571”)) AND (db:(LILACS))	-	
+CAPES	Síndrome HELLP	88	
+Cochrane	HELLP syndrome	07	
+
+To expand the scope of the searches, terminological variations were added in different languages, synonyms for controlled descriptors and Boolean operator AND, for the simultaneous occurrence of subjects, and Boolean operator OR, for the occurrence of another subject, as summarized in Chart 1.
+
+Studies that described nursing care for women with HELLP syndrome, without time or language limitations, were included. Duplicate articles in the databases, opinion articles, editorials, consensus(s), response letters or letters to the editor, abstracts presented in event annals and those that did not answer the review question were excluded. It is noteworthy that the level of evidence was not considered an exclusion criterion, as it is a topic little explored in the literature. PRISMA(17) methodology was adopted to select articles and it was illustrated in a flowchart (Figure 1).
+
+Figure 1 PRISMA flowchart for study selection. Uberaba, MG, Brazil, 2023.
+
+Source: prepared by the authors based on PRISMA SCr 2020(17).
+
+Study selection was carried out independently by three researchers, and disagreements were resolved by consensus, without the need to add a new reviewer at this stage. The initial analysis of selected studies was carried out by reading titles and abstracts, followed by exhaustive reading in full for the final selection of studies. Figure 1 illustrates the study selection process.
+
+In the search, 129 studies were located. In the first stage, duplicates were removed (n = 40) and 70 articles were excluded after reading the titles and abstracts because they did not portray the study topic or did not have a suitable study design for inclusion, according to established criteria. Of the 19 studies analyzed in full, ten were selected after reading them. Thus, the final sample was composed of ten studies.
+
+Data extraction was carried out by three researchers, independently. Standardized information was extracted by JBI, such as authorship, year, producing country, objectives, population and sample size, methodology used, outcomes, main results that answer the review question and risk of bias. The extracted data were tabulated and presented through narrative synthesis.
+
+RESULTS
+
+Ten studies made up the review, published between 2004 and 2022 (30%), seven (70%) published in English and three (30%) in Portuguese. Four studies (40%) were produced in the United States of America, three in Brazil (30%), two in India (20%), and one in Australia (10%).
+
+Among the designs, there was a predominance of case studies (five – 50%), descriptive studies (four – 40%) and a qualitative study using Grounded Theory (one – 10%), composing the sample of studies analyzed.
+
+In case studies, the occurrence of HELLP syndrome was found in second-time pregnant women (60%)(18,19,20) and in first-time pregnant women (40%)(21,22), aged between 24 and 28 years, who presented symptoms between 32 and 38 gestational weeks, as in all cases an emergency cesarean section was performed and all outcomes were live newborns who were discharged accompanied by their mothers. Only one study describes newborns with Apgar 6 and 7(21); another study describes newborn results as Apgar 9 and 9(18); and the others only mention healthy births(19,20,22).
+
+Among the descriptive studies, two studies stood out (40%) that addressed possible nursing diagnoses and interventions according to NANDA-NIC taxonomy(23,24). A study (20%) described nursing care as a multidisciplinary team member(25); a study described a care plan for care during the most critical moments of HELLP(26); and a study described a physical and emotional care plan aimed at women and their families based on Grounded Theory(27). Chart 2 presents the characteristics of the studies included in the review.
+
+Chart 2 Characteristics of studies included in the review (n = 10) – Uberaba, MG, Brazil, 2023.
+
+ID*	Author (s)	Year of publication	Country	Objectives	Population and sample size	Methodology	Results	Main findings	
+A1(26)	Adorno M, Maher-Griffiths C, Abadie HRG	2022	USA	Describe care in cases of HELLP syndrome.	NA	Descriptive study	Proposal for 11 specific nursing care measures to assist women with HELLP syndrome.	The study proposes a care plan for women with HELLP syndrome.	
+A2(23)	Beltrão HB, Brito CGR, Sousa DC, da Silva MEF, Brandão PF &dos Santos WA	2022	Brazil	Identify the main nursing diagnoses and nursing interventions for women with HELLP syndrome.	NA	Descriptive study based on a literature review and based on NANDA/NIC taxonomy	Eleven nursing diagnoses were described, eight of which were risk diagnoses and three were real. The diagnoses generated 55 possible nursing interventions.	The interventions are aimed at critical and intensive care for women, but also include care for the fetus/neonate and covering the emotional aspects of women and their families.	
+A3(21)	Bhatia R, Pathak V, Mor S & Gupta S	2020	India	Describe a case of a first-time pregnant woman diagnosed with eclampsia and HELLP syndrome.	01	Case study description	First-time pregnant woman, 26 years old, 38 weeks and four days of gestation, with a history of seizures for 48 hours. Upon admission, she was oliguric (100 ml diuresis/12 hours), with blood pressure of 200 x 110, fetal heart rate of 70 bpm and heart rate of 124 bpm. It abruptly progressed to cardiorespiratory arrest.
+She was immediately intubated and underwent cardiopulmonary resuscitation.
+Due to the persistence of cardiorespiratory arrest, an emergency cesarean section was performed. The newborn was born weighing 2,500 grams, asphyxiated, with Apgar scores 6/7. She received neonatal intensive care, including respiratory support with continuous positive airway pressure, monitoring of blood parameters, and administration of antibiotics to prevent infection.
+After the cesarean section, the patient was transferred to the Intensive Care Unit and received ventilatory support. Treatment included adequate antibiotic coverage, control of hypertension and monitoring of laboratory parameters such as platelet count and renal function. After 24 hours, the woman in labor was weaned from the ventilator. Dyas was discharged, without neurological sequel and in good condition.	The study points to the need for a multidisciplinary care team that is qualified to work in cardiopulmonary resuscitation. Timely cesarean section is also highlighted, in more serious cases, to guarantee better outcomes.	
+A4(20)	Cervantes R, Favre M& Carson-Romero C	2019	USA	Describe a case of second-time pregnant woman with epigastric pain.	01	Case study description	Second-time pregnant woman, with a previous miscarriage at screening, had intense epigastric pain and uterine contractions for three hours. Her cervix was closed and the fetus was tachycardic (fetal heart rate at 170 bpm). Intravenous therapy was started and a laboratory panel for pre-eclampsia was collected. Laboratory tests were highly suggestive of HELLP. An ultrasound was performed, which showed a large subcapsular hematoma in the liver. After an emergency cesarean section was indicated, a viable newborn was born without complications. During surgery, liver trauma was identified, which required suturing, which progressed to shock and disseminated intravascular coagulation. She required multiple transfusions, frequent visits to the surgical suite for reoperation and intubation for five days. She was discharged 12 days after giving birth.	Every complaint of epigastric pain must be carefully assessed and investigated, as it indicates the severity of the disease. It should be noted that pain precedes the laboratory test that indicates HELLP by several hours; therefore, in the complaint, a differential diagnosis must be carried out.	
+A5(25)	De Oliveira, RS, De Matos, IC, Da Silva, TBP, De Azevedo, NM, Andrade, M, &Do Espirito Santo, FH	2012	Brazil	Deepen understanding of HELLP syndrome and its evolution.	NA	Descriptive study based on narrative review	Eight studies made up the sample, five case studies, two reviews and one clinical trial.
+Predominantly laboratory diagnosis and the importance of investigating the syndrome in cases of hypertensive syndrome during pregnancy during prenatal care were observed. The importance of nursing consultation in screening and investigating symptoms is highlighted.	The importance of nursing consultation and in-depth investigation of symptoms is reinforced, especially for women with hypertensive syndrome during pregnancy.	
+A6(19)	DeshmukhA, Tarale S, Tembhre V & Pathade A	2022	India	Describe a case of a second-time pregnant woman with HELLP syndrome and severe anemia.	01	Case study description	Second-time pregnant woman, 24 years old, 37 weeks of gestation, complained of edema of the lower limbs bilaterally for a month, chest and abdominal pain, especially on the upper right side, vaginal bleeding, changes in vision, intolerance to heat, especially at night, but with cold palm, insomnia, weight loss due to nausea and vomiting, excessive sweating, dizziness, tremor, increased appetite and headache.
+Upon vaginal examination, the cervix was closed. Laboratory tests showed low hemoglobin values, a low platelet count and serum bilirubin within normal limits. Ultrasonography revealed a fetus with an age compatible with 31 weeks and altered cardiac flow.
+A cesarean section was performed under spinal anesthesia, however, during the procedure, the woman in labor developed a seizure and was immediately treated with magnesium sulfate, intravenous fluids and other medications, including oxytocin, vitamin K, tramadol and antibiotics.
+The newborn was born and cried immediately, indicating good vitality. However, due to low birth weight, the baby was transferred to the Neonatal Intensive Care Unit and received additional care, including continuous positive airway pressure, esophageal feedings every two hours, and administration of antibiotics.	The importance of investigating symptoms and considering the possibility of HELLP syndrome is highlighted, in addition to childbirth for better outcomes and care by a qualified multidisciplinary team.	
+A7(18)	Geake J, Dabscheck E &Reid D	2012	Australia	Describe a case of a second-time pregnant woman with cystic fibrosis who presented HELLP syndrome in the third trimester of pregnancy.	01	Case study description	Second-time pregnant woman, 26 years old, had cystic fibrosis as a comorbidity. Two weeks earlier, she experienced nausea and worsening respiratory function. After a week, she continued to experience nausea and worsening respiratory function. She opted for hospitalization, with blood pressure 153 x 89 mmHg, platelets at 101 thousand, alanine aminotransferase at 179 (3 x higher) and lactate dehydrogenase at 279 (<240). An ultrasound was performed with a suspected diagnosis of pre-eclampsia or HELLP. Two doses of corticosteroid therapy were applied within 12 hours, administering antihypertensive drugs.
+There was stability of the parameters, however, on the fifth day, she developed thrombocytopenia at 62 thousand, alanine aminotransferase at 118 and hemoglobin at 8.8 g/dl, with schistocytes in the blood. A diagnosis of HELLP syndrome was made.
+The cesarean section was performed ten hours after the result, and did not use magnesium sulfate. The newborn was born healthy, with Apgar scores 9/9. All parameters normalized postpartum.	The need for multidisciplinary teamwork, rigorous observation of symptoms and suspicion of HELLP syndrome, the importance of laboratory diagnosis, and urgent childbirth as definitive treatment were highlighted.	
+A8(27)	Kidner MC,
+Flanders-Stepans
+MB	2004	USA	Describe theory about the maternal experience of HELLP.	09	Qualitative study based on Grounded Theory, with nine HELLP survivors who had platelet counts below 100 thousand	HELLP‘S traumatic experiences are similar to those of a whirlwind. Even after recovering, the experience continues to be part of women’s emotional and physical aspects, described as common emotions: fear of death, frustration, anger and guilt, a universal feeling of loss of control and lack of information. In the speeches, the following categories emerged: Premonition; Symptoms; Feeling betrayed; The whirlwind; The losses; and No information and no control.	The study points to the need for empathetic care, involving everything from physical care to emotional care for women and their families.	
+A9(24)	Moraes MTS, Sousa RFO, Marcolino KMT, Davim RMB, CarvalhoCFS, Galvão CMB& Oliveira SX	2011	Brazil	Develop a proposal for a care plan for women with HELLP syndrome, taking into account the Nursing Process stages based on the main nursing diagnoses according to NANDA taxonomy.	NA	Descriptive study based on the search for diagnoses in NANDA taxonomy	Six risk diagnoses and four real diagnoses and 46 nursing interventions aimed at women with HELLP syndrome were identified.	The importance of systematizing nursing care in care planning as a guide for care for the team, women and family members is highlighted.	
+A10(22)	White A	2006	USA	Describe a case of a first-time pregnant woman diagnosed with HELLP syndrome.	01	Case study description	First-time pregnant woman, 28 years old, 32 weeks of gestation, who complained of extreme weakness.
+She requested emergency care due to severe pain in the upper quadrant of the abdomen and shoulders and edema of the lower limbs. When emergency services arrived, she was lying supine, pale, cold, and sweating profusely. She had blood pressure at 120x85 mmHg, heart rate at 140 bpm and respiratory rate at 28 bpm. Oxygen therapy 4l/minute and serum therapy were installed during transport.
+Upon admission, proteinuria was identified, indicating an emergency cesarean section. During the cesarean section, the obstetrician observed active hepatic hemorrhage. A ruptured hepatic hematoma and laceration involving the right lobe of the liver were found. Based on these findings, the diagnosis was expanded to HELLP syndrome. She received multiple transfusions and remained hospitalized in the CCU and on mechanical ventilation. She was discharged after 20 days of hospitalization. The newborn, who was born healthy, was discharged after ten days of life.	The study points to the need for physical care and emotional support for women and their families. Due to the severity of illnesses and possible losses, psychological aspects must be valued.	
+* ID – identification, article A followed by sequential number.
+
+This review also allowed the creation of a chart (Chart 3) listing nursing care for women diagnosed with HELLP syndrome. Care is divided into five domains: prenatal; in the presence of symptoms/diagnosis; in the immediate/mediate postpartum period; family care; care at or during hospital discharge. In the prenatal domain, five nursing care measures are described; in the presence of symptoms/diagnosis, 18 precautions are described; in the immediate/mediate postpartum period, seven interventions are described; in caring for family members, six are described; and upon discharge or during its validity, three items are described. Thus, the present review identified 39 nursing care measures aimed at assisting women with HELLP syndrome.
+
+Chart 3 Summary of nursing care for women with HELLP syndrome – Uberaba, MG, Brazil, 2023.
+
+Nursing care for women with HELLP syndrome	
+Prenatal care	
+1. Carefully assess signs and symptoms of HELLP syndrome in women with hypertensive syndromes during prenatal care(25)
+
+2. Pay attention to the symptoms of HELLP syndrome and the need for investigation based on nursing consultation during prenatal care(25)
+
+3. Carefully assess and investigate complaints of epigastric and/or right hypochondrium pain in all pregnant women with complaints(20)
+
+4. Differentiate signs and symptoms of HELLP syndrome from common signs of pregnancy(27)
+
+5. Value clinical history and physical examination as important diagnostic tools(27)
+
+	
+In the presence of symptoms/diagnosis	
+1. Promote emergency transportation/care(22)
+
+2. Provide maternal hospitalization, preferably in a CCU(23,26)
+
+3. During maternal hospitalization, request a place in the neonatal CCU(26)
+
+4. Continuously monitor mother and fetus(23,24,26), paying attention to vital signs.
+
+5. Strictly control blood pressure, paying attention to systolic values above 160 mmHg and diastolic values above 110 mmHg(26)
+
+6. Puncture and maintain patent large-caliber venous access(23,24)
+
+7. Perform blood gas analysis for acid-base control according to medical prescription(23,24)
+
+8. Perform a rigorous water balance(23,24)
+
+9. Administer oxygen therapy(23,24)
+
+10. Provide ventilatory care, if necessary(23,24)
+
+11. Supervise mechanical ventilation, if necessary(23,24)
+
+12. Maintain strict monitoring of the level of consciousness by applying the Glasgow Coma Scale(23,24)
+
+13. Prevent seizures with the use of magnesium sulfate, if necessary(26), as well as aspiration and possible injuries in case of seizures(24)
+
+14. Perform a detailed physical examination, including palpation of the right hypochondrium, inspection of the skin for signs of jaundice and/or pallor, observation of skin hydration, and presence of edema(23,24)
+
+15. If an emergency or immediate delivery is necessary, depending on gestational age, assess with the team the need and possibility of performing corticosteroid therapy(26)
+
+16. Plan the cesarean section in a timely manner(18,19,21,26)
+
+17. Use communication skills during care: reassure women; welcome with empathetic and work on active listening; always maintain eye contact during communication; and, if they are aware, inform them about the situation and allow them to make decisions(23,27)
+
+18. Promote care with a trained multidisciplinary team(21), including training in cases of cardiorespiratory arrest(18,21)
+
+	
+Immediate and immediate postpartum period	
+1. Strictly assess/monitor lochiation every 15 minutes(26) due to increased risk of bleeding
+
+2. After maternal stabilization, promote bonding with newborn(26)
+
+3. As soon as the postpartum woman is stable, encourage breastfeeding or perform mechanical milking, if necessary(26)
+
+4. Observe the surgical incision for phlogistic signs and bleeding(24)
+
+5. Promote aseptic care when handling probes, drains and catheters(24)
+
+6. Promote skin hydration care and change position periodically, if necessary(24)
+
+7. Assess maternal conditions and advise on newborn care(24)
+
+	
+Family care	
+1. Assure the family that the woman and fetus are receiving the best care possible(23)
+
+2. Respect the privacy of each family member(23)
+
+3. Actively listen to family members’ concerns, questions and feelings(23)
+
+4. Provide information about the nursing care provided(23)
+
+5. Promote family involvement in decisions and care(23)
+
+6. Offer necessary support/support(23)
+
+	
+Care at hospital discharge or during hospital stay	
+1. Promote continuous emotional support in the postpartum period(27)
+
+2. Promote emotional/psychological care for postpartum women and their families in cases of fetal/neonatal loss(22,27)
+
+3. Refer at discharge to a support group to share and talk about their experience and be able to give it a new meaning(27)
+
+	
+
+DISCUSSION
+
+In the present review, diagnoses of HELLP syndrome were more frequent in women in the second decade of life, similar to other case studies and population studies(28,29,30,31)
+
+Similarly, a study carried out in Alagoas showed a predominance of multiparous women in the cases identified(30). A study in India showed a higher frequency in primiparous women(29).
+
+Regarding the gestational age at diagnosis, cases are most commonly observed in the third trimester of pregnancy, followed by few cases in the second trimester(32), similarly to the reviewed studies and other studies(28,29,31,33). The importance of prenatal nursing care is highlighted, in order to identify signs and intervene early, as a study carried out in Alagoas showed that in all cases women underwent prenatal consultations, with 66% having more than six consultations, as recommended by the Ministry of Health, and 44% had consultations, however fewer than recommended(30).
+
+A study pointed out the association between HELLP syndrome and antiphospholipid antibody syndrome (APS) and in these cases, an increase in premature births and fetal deaths. It is therefore recommended that screening and treatment be carried out if one condition or another is suspected. Treatment for APS improves neonatal prognosis by preventing or improving placental insufficiency(32).
+
+It is worth highlighting the importance of screening symptoms, starting from nursing consultation, whether during prenatal care or upon admission of the woman in labor. Sudden, abrupt and severe abdominal pain in the right upper quadrant was a symptom described by 30%(34) to 78% of women(35). Increased blood pressure was present in between 65%(35) and 85%(34) of women. Visual changes were described by 20%(34) to 25% of women(29).
+
+In all studies reviewed, an emergency cesarean section was performed, similar to the outcomes presented in other studies, whose frequency ranged from 88%(30) to 91.1%(31). Only one study carried out in India showed that 84% of cases progressed to vaginal delivery(29). It is noteworthy that completing the birth immediately and as quickly as possible contributes to a better maternal and neonatal prognosis, being indicated as a treatment for cases, which contributes to the increase in emergency cesarean sections in this case(36).
+
+A timely delay in delivery is indicated if gestational age is between 24 and 34 weeks and there is no maternal or fetal compromise, in order to perform corticosteroid therapy to allow fetal lung maturation(36).
+
+Among the studies reviewed, there were no cases of neonatal deaths, however, it is noted that it is a common outcome in severe conditions(28,29,30,31). A meta-analysis showed that HELLP syndrome increases the risk of stillbirth by 1.56 times(37).
+
+Among live births, there is an increase in cases of prematurity(29–31), with rates between 46%(29) and 67%(31) of births, increase in Apgar scores below seven(29,30) and increase in cases of intrauterine growth restriction and low birth weight(29–31). In this regard, nursing care is necessary to avoid prematurity and, when this is not possible, offer qualified nursing care and provide for the hospitalization of these newborns in specialized units in order to obtain better outcomes.
+
+It is also noteworthy that a meta-analysis showed that HELLP syndrome contributed to an increase in the risk of acute renal failure by 4.87 times(37) and by 3.7 times the risk of maternal death(37). Among the case outcomes, hospitalization in Intensive Care Units(28,33) for monitoring, polytransfusions(28,29,33) and need for liver transplantation were observed(33). Due to the critical nature, there is a need for rigorous monitoring and intensive care after birth(32) to ensure a better maternal outcome.
+
+The need to extend care beyond the treatment of the syndrome is highlighted to preserve women’s mental health, which can be undermined due to severity/criticality and possible losses. A review study pointed out mental health changes in women who had HELLP syndrome, with emphasis on an increased prevalence of depression, anxiety and post-traumatic stress syndrome. However, due to studies not controlling confounding factors, the results were inconclusive(38). Therefore, care must be taken regarding the preservation or restoration of these women’s mental health, as mentioned in the reviewed articles.
+
+As previously described, HELLP syndrome is a serious condition that, if left untreated, can lead to maternal death. Therefore, when thinking about care, it is necessary to think about possible delays that could prevent women from receiving adequate and necessary care. Based on the three delays model, it is necessary to rethink care in the three components. The first delay occurs in the decision to seek care. This first pillar is influenced by the refusal of women and family members(39). Thus, strengthening educational practices and qualified prenatal care can be fundamental to avoid it.
+
+The second delay refers to women’s route and access to health services, which range from geographic factors to transport and infrastructure. The third delay consists of receiving adequate care when there is access to health services(39). At these points, it is necessary to guarantee access to networked healthcare, with its different levels of care. The importance of health services thinking about the phenomenon of delays to analyze solutions for maternal morbidity and mortality is reinforced.
+
+Furthermore, it is necessary to consider the critical nodes of care. The study proposes a care plan based on evidence, however we identified the relevance of: strengthening care at the entrance to maternity wards, reinforcing the reception methodology and risk classification as a qualification strategy; ensuring adequate staffing so that the presence of nurses caring for a woman with HELLP does not make it impossible for nurses to care for other women in labor; and strengthening continuing education actions with a view to qualified interprofessional shared care.
+
+The importance of taxonomies for nurses’ decision-making is highlighted(40). Although only two studies in the present review described diagnoses and interventions and there are no specific diagnoses or interventions for the condition, taxonomies contribute to care planning(24) as well as effective decision-making in the face of an obstetric emergency(22), as is the case with HELLP syndrome.
+
+However, there is a lack of studies that address nursing care in cases of HELLP syndrome, which compromises the discussion of the findings and is a limitation of this study. Furthermore, there are few studies published on the topic today, which compromises the comparability of results. At the same time, the implications of this review for practice are highlighted, as care inherent to each phase of the pregnancy-puerperal cycle in which the syndrome is detected is analyzed and presented.
+
+CONCLUSION
+
+The present review highlighted the magnitude of the syndrome; however, studies are scarce. There was a predominance of case studies, followed by descriptive studies. The review made it possible to identify 39 nursing care measures aimed at assisting women with HELLP syndrome.
+
+DOI: 10.1590/1980-220X-REEUSP-2024-0116pt
+Subjects: Revisão
+
+Cuidados de enfermagem a mulheres com síndrome HELLP: scoping review
+
+https://orcid.org/0009-0002-3566-0634 Arduini Pâmela Silva 1
+https://orcid.org/0000-0003-1203-2504 de Resende Cynthya Viana 1
+https://orcid.org/0000-0002-4308-5978 da Silva Jéssica Aparecida 1
+https://orcid.org/0000-0002-5199-7328 Ruiz Mariana Torreglosa 2
+1 Universidade Federal do Triângulo Mineiro, Uberaba, MG, Brasil.
+1 Universidade Federal do Triângulo Mineiro, Programa de Pós-Graduação em Atenção à Saúde, Uberaba, MG, Brasil.
+Autor correspondente: Mariana Torreglosa Ruiz, Praça Manoel Terra, 330, Centro, 38025-015 – Uberaba, MG, Brasil, mariana.ruiz@uftm.edu.br
+Keywords: Síndrome HELLP, Cuidado de Enfermagem, Enfermagem Obstétrica
+
+INTRODUÇÃO
+
+De acordo com a Organização Mundial da Saúde (OMS), as síndromes hipertensivas na gestação são responsáveis por um décimo das mortes maternas(1). No cenário nacional, dados do Departamento de Informática do Sistema Único de Saúde (DATASUS) apontam que, no período compreendido entre 1996 e 2021, registraram-se mais de 45 mil óbitos maternos e 2.808 óbitos tardios, totalizando 48.301 óbitos maternos. Desses, 62% foram decorrentes de causas obstétricas diretas, e as síndromes hipertensivas representaram 34,4% de todas as causas (16.622 óbitos), sendo a eclâmpsia o primeiro motivo de morte materna no país(2).
+
+Revisão de estudos brasileiros sobre pré-eclâmpsia e eclâmpsia apontou frequência de pré-eclâmpsia de 6,7% e, de eclâmpsia, entre 1,7% e 6,2%, e a síndrome HELLP representou a evolução de um em cada 30 casos de pré-eclâmpsia, sendo uma condição pouco relatada, embora represente maior gravidade da evolução dos quadros(3).
+
+A pré-eclâmpsia se caracteriza por aumento pressórico após a vigésima semana gestacional, associado à proteinúria, que pode ser resolvido após o nascimento ou evoluir com complicações e sequelas. Já a eclâmpsia consiste em quadro que cursa com convulsões não atribuídas a causas neurológicas em pacientes com diagnóstico prévio de pré-eclâmpsia, sendo classificada como uma complicação da pré-eclâmpsia. A síndrome HELLP é um agravamento dos quadros de pré-eclâmpsia cursando com hemólise (H), elevação da das enzimas hepáticas (EL) e plaquetopenia grave (LP), sendo considerada a evolução de maior gravidade das síndromes hipertensivas gestacionais(4,5).
+
+Considera-se aumento pressórico na gestação valores de pressão arterial sistólica (PAS) maior ou igual a 140 mmHg e/ou de diastólica (PAD) maior ou igual a 90 mmHg, aferidos com técnica adequada e confirmados por duas medidas com intervalo de quatro horas. Obtido valor de PAS superior a 160 mmHg e/ou de PAD superior a 110 mmHg, recomenda-se nova aferição em 15 minutos e, se mantidos os valores, iniciar tratamento imediatamente. Já a proteinúria é confirmada laboratorialmente pela presença de 300 mg ou mais de proteínas em urina de 24 horas ou resultado da relação proteína/creatinina urinária igual ou superior a 0,3, ou, caso não seja possível a realização do exame de 24 horas, a presença de pelo menos uma cruz em amostra de urina isolada(4,5).
+
+A primeira descrição sobre a síndrome HELLP data de 1982, pelo médico Louis Weinstein(6), que observou o surgimento da sintomatologia a partir de 20 semanas gestacionais assim como suas primeiras manifestações no puerpério. A síndrome tem como sintomatologia frequente o mal-estar súbito, ocorrência de náuseas e vômitos, e dor abdominal abrupta e intensa no quadrante superior direito do abdome e/ou epigástrica, sendo a dor o sintoma característico da síndrome. Geralmente, o quadro associa-se à complicação da pré-eclâmpsia(7), contudo, em 15% a 20% dos casos, podem ocorrer sem aumento hipertensivo ou sem proteinúria(8).
+
+Para conclusão do diagnóstico, são necessários exames laboratoriais, constituindo-se em critérios: 1. Hemólise (esfregaço anormal sugestivo de anemia hemolítica microangiopática caracterizada por presença de esquistócitos); 2. Bilirrubina total acima de 1,2 mg/dl; 3. Lactato desidrogenase acima de 6.000 U/l ou hepatoglobina menor do que o limite inferior para normalidade; 4. Enzima hepática alanina aminotransferase com valor duas vezes superior ao limite da normalidade; e 5. Contagem de plaquetas inferior a 100.000/μl. Desses critérios, a presença de um a dois sugere possibilidade de HELLP, e três critérios definem o diagnóstico(9).
+
+Entre as possíveis complicações da síndrome, são frequentes edema pulmonar, lesão renal reversível ou não, necessidade de politransfusões, internação em Centro de Terapia Intensivo (CTI) e coagulação intravascular disseminada(8,9), o que confere maior gravidade aos casos.
+
+A síndrome HELLP caracteriza-se como um quadro grave e agudo, consistindo em uma emergência obstétrica. Acomete uma mulher a cada 45.000 nascimentos vivos, representando de 0,1% a 0,9% das complicações durante o ciclo gravídico-puerperal, sendo que de 10% a 30% dos quadros se apresenta como uma complicação da pré-eclâmpsia(7). Cerca de 45% dos casos de HELLP evoluem com gravidade(10). Todos os casos requerem cuidados intensivos, e 1% evolui para ruptura hepática(11), condição que constitui risco de mortalidade, principalmente quando as plaquetas atingem níveis inferiores a 50.000(10,11).
+
+Na maioria dos casos, a etiopatogenia é desconhecida. No entanto, a nuli ou multiparidade, idade superior a 30 anos, história de síndrome HELLP em gestação prévia, hipertensão arterial crônica, diabetes com diagnóstico pré-gestacional, cardiopatias, obesidade, doenças hepáticas crônicas, alterações placentárias e anormalidades congênitas são descritos como fatores de risco para a síndrome HELLP(12).
+
+Além do impacto negativo e possíveis complicações na vida da mulher(13,14), as síndromes hipertensivas no período gravídico-puerperal estão associadas com a prematuridade, e essa é a principal causa de morte em crianças menores de cinco anos de idade(15).
+
+A assistência pré-natal de qualidade é um fator protetor para as complicações da síndrome, que embora não possa ser prevenida, quanto mais precoce a realização do diagnóstico, maior a possibilidade de redução de danos. A interrupção da gestação está indicada como tratamento assim que estabilizado o quadro, ou seja, não deve ser intempestiva, nem imediata, mas planejada para evitar desfechos negativos(5). Dessa forma, devido à sua complexidade e ao alto potencial de complicações, identifica-se a importância de assistência de enfermagem qualificada e pautada em evidências científicas.
+
+A presente pesquisa visa apresentar a síntese do conhecimento sobre os cuidados assistenciais de enfermagem às mulheres com síndrome HELLP, de forma que permita ao enfermeiro a tomada de decisão segura e precisa baseada em resultados prévios descritos na literatura. Diante do exposto, este estudo teve como objetivo mapear evidências sobre a assistência de enfermagem às mulheres com síndrome HELLP.
+
+MÉTODO
+
+Tipo de Estudo
+
+Scoping review, desenvolvida com base nas recomendações do JBI(16). Desse modo, percorreram-se as etapas de: (1) estabelecimento do título e da pergunta de revisão a partir do mnemônico do PCC, sendo que P: População, C: Conceito e C: Contexto; (2) exploração do estado da arte do problema de investigação com redação da introdução da revisão; (3) definição dos critérios de inclusão; (4) delineamento da estratégia de busca (fontes, descritores e referências manuais a partir da leitura das publicações selecionadas); (5) seleção da fonte de evidência (examinador e protocolo); (6) seleção dos artigos – processo guiado pelo fluxograma Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA-ScR)(17); (7) extração dos dados; (8) análise das evidências; e (9) apresentação dos resultados de forma tabular e por meio de mapeamento descritivo. Protocolo foi registrado no Open Science Framework (https://osf.io/d8kup).
+
+Estratégia de Busca
+
+Para elaborar a questão de revisão, utilizou-se o mnemônico PCC, sendo que a População (P) incluiu mulheres gestantes ou puérperas, Conceito (C) incluiu cuidados de enfermagem, e Contexto (C) incluiu síndrome HELLP. Dessa forma, a questão de revisão foi: quais as evidências sobre cuidados de enfermagem a mulheres com síndrome HELLP?
+
+As buscas foram realizadas em maio de 2023, de forma independente, por dois revisores, um mestrando e um doutor. Um revisor tem experiência com estratégia de busca e curso de treinamento para scoping reviews, e ambos são especialistas na área da saúde materno-infantil. A busca foi validada por um bibliotecário. Utilizaram-se os descritores HELLP Syndrome, Nursing Care e Obstetric Nursing. As bases de dados US National Library of Medicine National Institutes of Health (MEDLINE/PubMed), Web of Science (WoS), Excerpta Medica DataBASE (EMBASE), SciVerse Scopus, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Catálogo de Teses e Dissertações da CAPES e Cochrane Library foram selecionadas para consulta, correlacionando os descritores HELLP Syndrome, Nursing Care e Obstetric Nursing. Não foram aplicados filtros de data, idioma e/ou desenho de estudo. As estratégias de busca encontram-se descritas no Quadro 1, com o retorno numérico obtido.
+
+Quadro 1 Estratégias de buscas nas bases de dados e retorno numérico obtido – Uberaba, MG, Brasil, 2023.
+
+Base de dados	Estratégia de busca	n	
+PubMed	(((“HELLP Syndrome” [Mesh] OR Syndrome, HELLP OR Hemolysis, Elevated Liver Enzymes, Lowered Platelets) AND (“Nursing Care” [Mesh] OR Care, Nursing OR Management, Nursing Care OR Nursing Care Management OR “Obstetric Nursing” [Mesh] OR Nursing, Obstetric OR Nursings, Obstetric OR Obstetric Nursings OR Nursing, Obstetrical OR Nursings, Obstetrical OR Obstetrical Nursings OR Obstetrical Nursing)	25	
+EMBASE	(‘HELLP Syndrome’/exp OR ‘HELLP (hemolysis, elevated liver enzymes and low platelets) syndrome’ OR ‘hemolysis, elevated liver enzymes, and low platelet count syndrome’ OR ‘hemolysis, elevated liver enzymes, and low platelets syndrome’ OR ‘hemolysis, elevated liver enzymes, low platelet count syndrome’ OR ‘syndrome HELLP’ OR ‘HELLP syndrome’) AND (‘Obstetrical nursing’/exp OR ‘obstetric nursing’ OR ‘obstetrics nursing’ OR ‘obstetrical nursing’ OR ‘Nursing’/exp OR ‘hospital nursing service’ OR ‘nursing service’ OR ‘nursing service, hospital’ OR ‘nursing services’ OR ‘nursing support’ OR ‘nursing, private duty’ OR ‘nursing, supervisory’ OR ‘office nursing’ OR ‘private duty nursing’ OR ‘supervisory nursing’ OR ‘nursing’) AND [embase]/lim NOT ([embase]/lim AND [medline]/lim)	28	
+Scopus	ALL (“HELLP Syndrome”) AND TITLE-ABS-KEY (*nursing AND care* OR *obstetric AND nursing* )	54	
+WoS	(ALL=(HELLP syndrome*)) AND ALL=(Nursing care*) AND (ALL=(HELLP syndrome*)) AND ALL=(obstetric nursing*)	27	
+LILACS	(tw:(“Síndrome HELLP” OR “HELLP Syndrome” OR “HELLP syndrome” OR C12.050.703.395.186 )) AND (tw:(“Cuidados de Enfermagem” OR “Nursing Care” OR “Atención de Enfermería” OR “Soins infirmiers” OR “Assistência de Enfermagem” OR “Atendimento de Enfermagem” OR “Cuidado de Enfermagem” OR “Gestão da Assistência de Enfermagem” OR “Sistematização da Assistência de Enfermagem” OR “E02.760.611” “OR N02.421.533” OR “Enfermagem Obstétrica” OR “Obstetric Nursing” OR “Enfermería Obstétrica” OR “Soins infirmiers em obstétrique” OR “H02.478.676.570” OR “N02.421.533.571”)) AND (db:(LILACS))	–	
+CAPES	Síndrome HELLP	88	
+Cochrane	HELLP syndrome	07	
+
+Para ampliar o alcance das buscas, foram adicionadas variações terminológicas nos diferentes idiomas, sinônimos dos descritores controlados e os operadores booleanos AND, para ocorrência simultânea de assuntos, e operadores booleanos OR, para ocorrência de um outro assunto, conforme sintetizado no Quadro 1.
+
+Foram incluídos estudos que descrevessem cuidados de enfermagem a mulheres com síndrome HELLP, sem delimitação de tempo ou idioma. Foram excluídos artigos duplicados nas bases, artigos de opinião, editoriais, consenso(s), carta resposta ou cartas ao editor, resumos apresentados em anais de eventos e aqueles que não respondessem à questão de revisão. Ressalta-se que o nível de evidência não foi considerado critério de exclusão, por se tratar de tema pouco explorado na literatura. Adotou-se a metodologia PRISMA(17) para seleção dos artigos, e a mesma foi ilustrada em fluxograma (Figura 1).
+
+Figura 1 Fluxograma PRISMA de seleção dos estudos. Uberaba, MG, Brasil, 2023.
+
+Fonte: elaborado pelos autores com base no PRISMA SCr 2020(17).
+
+A seleção dos estudos foi realizada, de modo independente, por três pesquisadores, e as discordâncias foram resolvidas por consenso, sem necessidade de acréscimo de novo revisor nessa etapa. A análise inicial dos estudos selecionados foi realizada a partira da leitura do título e resumo, seguida de leitura exaustiva na íntegra para a seleção final dos estudos. A Figura 1 ilustra o processo de seleção dos estudos.
+
+Na busca, foram localizadas 129 publicações. Na primeira etapa, as duplicatas foram removidas (n = 40) e 70 artigos foram excluídos após a leitura dos títulos e resumos, por não retratarem o tema de estudo ou não possuírem desenho/tipo de estudo adequado para inclusão, conforme os critérios estabelecidos. Das 19 publicações analisadas na íntegra, dez foram selecionadas após a leitura das mesmas. Dessa forma, a amostra final foi composta por dez estudos.
+
+A extração de dados foi realizada por três pesquisadores, independentemente. Foram extraídas informações padronizadas pelo JBI, como autoria, ano, país produtor, objetivos, população e tamanho amostral, metodologia utilizada, desfechos, principais resultados que respondem à questão de revisão e risco de viés. Os dados extraídos foram tabulados e apresentados através de síntese narrativa.
+
+RESULTADOS
+
+Dez estudos compuseram a revisão, publicados entre 2004 e 2022 (30%), sete (70%) publicados em inglês e três (30%) em português. Quatro estudos (40%) foram produzidos nos Estados Unidos, três, no Brasil (30%), dois, na Índia (20%), e um, na Austrália (10%).
+
+Entre os desenhos, verificou-se predominância de estudos de caso (cinco – 50%), estudos descritivos (quatro – 40%) e um estudo qualitativo com uso da Teoria Fundamentada nos Dados (um – 10%), compondo a amostra dos estudos analisados.
+
+Nos estudos de caso, verificou-se a ocorrência da síndrome HELLP em secundigestas (60%)(18–20) e em primigestas (40%)(21,22), com idade entre 24 e 28 anos, que apresentaram sintomas entre 32 e 38 semanas gestacionais, sendo que, em todos os casos, realizou-se cesárea de emergência e todas tiveram como desfechos recém-nascidos vivos que receberam alta acompanhados das mães. Apenas um estudo descreve recém-nascido com escores de Apgar 6 e 7(21); outro estudo descreve como resultado neonato com Apgar 9 e 9(18); e os demais mencionam apenas nascimentos saudáveis(19,20,22).
+
+Entre os estudos descritivos, destacaram-se dois estudos (40%) que abordaram os possíveis diagnósticos e intervenções de enfermagem segundo a taxonomia NANDA-NIC(23,24). Estudo (20%) descreveu os cuidados de enfermagem enquanto membro da equipe multidisciplinar(25); estudo descreveu plano de cuidados para assistência durante os momentos mais críticos da HELLP(26); e estudo descreveu um plano de cuidados físicos e emocionais voltados para a mulher e seus familiares a partir da Teoria Fundamentada nos Dados(27). No Quadro 2, são apresentadas as características dos estudos inclusos na revisão.
+
+Quadro 2 Características dos estudos inclusos na revisão (n = 10) – Uberaba, MG, Brasil, 2023.
+
+ID*	Autor(es)	Ano de publicação	País	Objetivos	População e tamanho amostral	Metodologia	Resultados	Principais achados	
+A1(26)	Adorno M, Maher-Griffiths C, Abadie HRG	2022	Estados Unidos	Descrever cuidados em casos de síndrome HELLP.	NA	Estudo descritiv o	Proposta de 11 cuidados de enfermagem específicos para assistência a mulheres com síndrome HELLP.	O estudo propõe um plano de cuidados assistenciais à mulher com síndrome HELLP.	
+A2(23)	Beltrão HB, Brito CGR, Sousa DC, da Silva MEF, Brandão PF & dos Santos WA	2022	Brasil	Identificar os principais diagnósticos de enfermagem e intervenções de enfermagem para mulheres com síndrome HELLP.	NA	Estudo descritivo a partir de revisão na literatura e fundamentado na taxonomia NANDA/NIC.	Descreveram-se 11 diagnósticos de enfermagem, sendo oito diagnósticos de risco e três reais. Os diagnósticos geraram 55 possíveis intervenções de enfermagem.	As intervenções são voltadas para cuidados críticos e intensivos para a mulher, mas também compreendem cuidados com feto/neonato e abrangência dos aspectos emocionais da mulher e família.	
+A3(21)	Bhatia R, Pathak V, Mor S & Gupta S	2020	Índia	Descrevercaso de primigesta com diagnóstico de eclâmpsia e síndrome HELLP.	01	Descrição de estudo de caso	Primigesta, 26 anos, com 38 semanas e quatro dias de gestação, com história de convulsões há 48 horas. Na admissão, encontrava-se oligúrica (100 ml de diurese/ 12 horas), com pressão arterial de 200 x 110, batimentos cardíacos fetais de 70 bpm e frequência cardíaca de 124 bpm. Evoluiu abruptamente para parada cardiorrespiratória.
+Foi imediatamente intubada e submetida à reanimação cardiopulmonar.
+Devido à persistência de parada cardiorrespiratória, realizou-se cesárea de urgência. O neonato nasceu com 2.500 gramas, asfixiado, com escores de Apgar 6/7. Recebeu cuidados intensivos neonatais, incluindo suporte respiratório com pressão positiva contínua nas vias aéreas, monitoramento dos parâmetros sanguíneos e administração de antibióticos para prevenção de infecção.
+Após a cesariana, a paciente foi transferida para a Unidade de Terapia Intensiva e recebeu suporte ventilatório.
+O tratamento incluiu cobertura antibiótica adequada, controle da hipertensão e acompanhamento dos parâmetros laboratoriais, como contagem de plaquetas e função renal. Após 24 horas, a puérpera foi desmamada do ventilador. O binômio recebeu alta, sem sequelas neurológicas e em bom estado.	O estudo aponta para a necessidade de equipe multidisciplinarna assistência que possua capacitação para atuar na reanimação cardiopulmonar . Também destaca-se a cesárea em tempo hábil, em casos de maior gravidade, para garantia de melhores desfechos.	
+A4(20)	Cervantes R, Favre M & Carson-Romero C	2019	Estados Unidos	Descrever caso de secundigestas com dor epigástrica.	01	Descrição de estudo de caso	Secundigesta, com aborto anterior na triagem, apresentava dor epigástrica intensa e contrações uterinas há três horas. O colo estava fechado e o feto estava taquicárdico (batimentos cardíacos fetais em 170 bpm). Iniciou-se terapia endovenosa e foi colhido painel laboratorial para pré-eclâmpsia. Os exames laboratoriais eram altamente sugestivos para HELLP. Realizou-se ultrassonografia, que mostrou grande hematoma subcapsular no fígado. Após indicada cesárea de emergência, recém-nascido viável nasceu sem intercorrências. Durante a cirurgia, identificou-se trauma hepático, que necessitou de sutura, evoluiu com choque e coagulação intravascular disseminada. Necessitou de múltiplas transfusões, idas frequentes ao bloco cirúrgico para reabordagem e de intubação por cinco dias. Recebeu alta com 12 dias após o parto.	Toda queixa de dor epigástrica deve ser cuidadosamente avaliada e investigada, pois indica gravidade da doença. Ressalta-se que a dor precede o exame laboratorial que aponta HELLP em várias horas; portanto, na queixa, deve-se realizar o diagnóstico diferencial.	
+A5(30)	De Oliveira, RS, De Matos, IC, Da Silva, TBP, De Azevedo, NM, Andrade, M, & Do Espirito Santo, FH	2012	Brasil	Aprofundar a compreensão sobre a síndrome HELLP e sua evolução.	NA	Estudo descritivo a partir de revisão narrativa	Oito estudos compuseram a amostra, sendo cinco estudos de caso, duas revisões e um ensaio clínico.
+Observaram-se diagnóstico predominantemente laboratorial e a importância da investigação da síndrome nos casos de síndrome hipertensiva na gestação durante o pré-natal. Destaca-se a importância da consulta de enfermagem na triagem e investigação da sintomatologia.	Reforça-se a importância da consulta de enfermagem e da investigação dos sintomas em profundidade, em especial às mulheres com síndrome hipertensiva na gestação.	
+A6(19)	DeshmukhA, Tarale S, Tembhre V & Pathade A	2022	Índia	Descrevercaso de secundigesta com síndrome HELLP e anemia severa.	01	Descrição de estudo de caso	Secundigesta, 24 anos, 37 semanas de gestação, apresentou queixa de edema de membros inferiores bilateralmente há um mês, dor torácica e abdominal, especialmente no lado superior direito, sangramento vaginal, alterações na visão, intolerância ao calor, especialmente à noite, mas com palma da mão fria, insônia, perda de peso devido a náuseas e vômitos, suor excessivo, tontura, tremor, aumento do apetite e cefaleia.
+Ao toque vaginal, o colo do útero estava fechado. Exames laboratoriais mostraram valores de hemoglobina baixos, contagem de plaquetas baixa e bilirrubina sérica dentro dos limites normais. A ultrassonografia revelou um feto com idade compatível com 31 semanas e alteração de fluxo cardíaco.
+Realizou-se cesárea sob raquianestesia, no entanto, durante o procedimento, a parturiente apresentou convulsão e foi tratada imediatamente com sulfato de magnésio, fluidos intravenosos e outros medicamentos, incluindo ocitocina, vitamina K, tramadol e antibióticos.
+O neonato nasceu e chorou imediatamente, indicando boa vitalidade. No entanto, devido ao baixo peso ao nascer, o bebê foi transferido para a Unidade de Terapia Intensiva Neonatal e recebeu cuidados adicionais, incluindo pressão positiva contínua nas vias aéreas, alimentação esofágica a cada duas horas e administração de antibióticos.	Ressalta-se a importância da investigação de sintomas e de se aventar a possibilidade de síndrome HELLP, além do parto para melhores desfechos e do atendimento por equipe multidisciplinar capacitada.	
+A7(18)	Geake J, Dabscheck E & Reid D	2012	Austrália	Descrevercaso de secundigesta com fibrose cística que apresentousíndrome HELLP no terceiro trimestre gestacional.	01	Descrição de estudo de caso	Secundigesta, 26 anos, tinha como comorbidade a fibrose cística. Duas semanas antes, apresentou náuseas e piora da função respiratória. Com uma semana, manteve náuseas e piora da função respiratória. Optou-se por internação, com pressão arterial 153 x 89 mmHg, plaquetas a 101 mil, alanina aminotransferase a 179 (3 x superior) e lactato desidrogenase a 279 (< 240). Realizou-se ultrassonografia com suspeita diagnóstica de pré-eclâmpsia ou HELLP. Aplicaram-se duas doses de corticoterapia em 12 horas, administrando anti-hipertensivos.
+Houve estabilidade dos parâmetros, contudo, no quinto dia, evoluiu com plaquetopenia a 62 mil, alanina aminotransferase a 118 e hemoglobina a 8,8 g/dl, com esquistócitos no sangue. Foi fechado diagnóstico de síndrome HELLP.
+A cesárea foi realizada após dez horas do resultado, e não utilizou sulfato de magnésio. O recém-nascido nasceu saudável, com escores de Apgar 9/9. Todos os parâmetros normalizaram-se pós-parto.	Destacou-se a necessidade de: trabalho em equipe multidisciplinar; observar rigorosamente sintomas e suspeitar de síndrome HELLP; a importância do diagnóstico laboratorial; parto urgente como tratamento definitivo.	
+A8(27)	Kidner MC, Flanders-Stepans MB	2004	Estados Unidos	Descrever teoria sobre a experiência materna da HELLP.	09	Estudo qualitativo a partir da Teoria Fundamentada nos Dados, com nove sobreviventes à HELLP que tiveram contagem de plaquetas inferior a 100 mil	As experiências traumáticas da HELLP são semelhantes às de um redemoinho. Mesmo recuperadas, a experiência continua a fazer parte do emocional e físico das mulheres, descritas como emoções comuns o medo da morte, frustração, raiva e culpa, sentimento universal de perda de controle e de falta de informações. Nas falas, emergiram as categorias: Premonição; Sintomas; Sentir-se traída; O redemoinho; As perdas; e Sem informações e sem controle.	O estudo aponta para necessidade de cuidado empático, envolvendo desde cuidados físicos aos cuidados emocionais com a mulher e sua família.	
+A9(24)	Moraes MTS, Sousa RFO, Marcolino KMT, Davim RMB, CarvalhoCFS, Galvão CMB & Oliveira SX	2011	Brasil	Elaborar uma proposta de plano assistencial às mulheres com síndrome HELLP, tendo em vista as etapas do Processo de Enfermagem baseado nos principais diagnósticos de enfermagem segundo a taxonomia NANDA.	NA	Estudo descritivo a partir da busca de diagnósticos na taxonomia NANDA	Identificaram-se seis diagnósticos de risco e quatro diagnósticos reais e 46 intervenções de enfermagem voltados à mulher com síndrome HELLP.	Ressalta-se a importância da sistematização da assistência de enfermagem no planejamento da assistência como norteador do cuidado para equipe, mulheres e familiares.	
+A10(22)	White A	2006	Estados Unidos	Descrevercaso de primigesta com diagnóstico de síndrome HELLP.	01	Descrição de estudo de caso	Primigesta, 28 anos, 32 semanas de gestação, que se queixava de fraqueza extrema.
+Solicitou atendimento de emergência por dor intensa no quadrante superior do abdome e em ombros e edema de membros inferiores. Quando o serviço de emergência chegou, ela estava deitada em decúbito dorsal, pálida, fria, com sudorese intensa. Ela tinha pressão arterial a 120x85 mmHg, frequência cardíaca a 140 bpm e frequência respiratória a 28 ipm. Instalada oxigenoterapia 4l/minuto e soroterapia durante o transporte.
+Na internação, identificou-se proteinúria, indicando cesárea de emergência. Durante a realização da cesárea, o obstetra observou hemorragia hepática ativa. Constatou-se hematoma hepático roto e laceração envolvendo o lobo direito do fígado. Com base nessas descobertas, o diagnóstico foi expandido para síndrome HELLP. Foi politransfundida, permaneceu internada em CTI e em ventilação mecânica. Recebeu alta com 20 dias de internação. O neonato, que nasceu saudável, recebeu alta após dez dias de vida.	O estudo aponta para a necessidade de cuidados físicos e de apoio emocional para as mulheres e suas famílias. Devido à gravidade das doenças e possíveis perdas, os aspectos psicológicos devem ser valorizados.	
+* Id – identificação, A de artigo seguido de número sequencial.
+
+A presente revisão permitiu ainda a confecção de um quadro (Quadro 3) listando os cuidados de enfermagem a mulheres com diagnóstico de síndrome HELLP. Os cuidados são divididos em cinco domínios: pré-natal; na vigência de sintomas/diagnóstico; no puerpério imediato/mediato; cuidados com familiares; cuidados na alta hospitalar ou na sua vigência. No domínio pré-natal, são descritos cinco cuidados de enfermagem; na vigência de sintomas/diagnóstico, são descritos 18 cuidados; no puerpério imediato/mediato, são descritas sete intervenções; no cuidado com familiares, são descritos seis; e na alta ou na sua vigência, são descritos três itens. Assim, a presente revisão permitiu identificar 39 cuidados de enfermagem voltados à assistência à mulher com síndrome HELLP.
+
+Quadro 3 Sumário de cuidados de enfermagem a mulheres com síndrome HELLP – Uberaba, MG, Brasil 2023.
+
+Cuidados de enfermagem a mulheres com síndrome HELLP	
+Pré-natal	
+1. Avaliar criteriosamente sinais e sintomas de síndrome HELLP em mulheres com síndromes hipertensivas durante o pré-natal(25)
+
+2. Atentar-se para sintomatologia da síndrome HELLP e a necessidade de investigação a partir da consulta de enfermagem durante a assistência pré-natal(25)
+
+3. Avaliar e investigar cuidadosamente a queixa de dor epigástrica e/ou no hipocôndrio direito em todas as gestantes com queixa(20)
+
+4. Diferenciar sinais e sintomas de síndrome HELLP de sinais comuns da gestação(27)
+
+5. Valorizar história clínica e exame físico como importantes ferramentas diagnósticas(27)
+
+	
+Na vigência de sintomas/diagnóstico	
+1. Promover transporte/assistência de emergência(22)
+
+2. Providenciar internação materna preferencialmente em CTI(23,26)
+
+3. Na vigência de internação materna, solicitar vaga de CTI neonatal(26)
+
+4. Monitorar continuamente mãe e feto(23,24,26), atentando-se para os sinais vitais.
+
+5. Controlar rigorosamente a pressão arterial, atentando para valores de sistólica superiores a 160 mmHg e de diastólica superiores a 110 mmHg(26)
+
+6. Puncionar e manter acesso venoso de grosso calibre pérvio(23,24)
+
+7. Realizar gasometria para o controle ácido-básico, de acordo com prescrição médica(23,24)
+
+8. Realizar balanço hídrico rigoroso(23,24)
+
+9. Administrar oxigenoterapia(23,24)
+
+10. Prover assistência ventilatória, se necessário(23,24)
+
+11. Supervisionar a ventilação mecânica, se necessário(23,24)
+
+12. Manter vigilância rigorosa do nível de consciência por meio da aplicação da escala de coma de Glasgow(23,24)
+
+13. Prevenir convulsões com uso de sulfato de magnésio, se necessário(26), assim como aspiração e possíveis lesões em caso de convulsões(24)
+
+14. Realizar exame físico detalhado, incluindo palpação do hipocôndrio direito, inspeção da pele para sinais de icterícia e/ou palidez, observação da hidratação da pele e presença de edemas(23,24)
+
+15. Se necessidade de parto de emergência ou imediato, a depender da idade gestacional, avaliar junto à equipe a necessidade e a possibilidade de realizar corticoterapia(26)
+
+16. Planejar a cesárea em tempo hábil(18,19,21,26)
+
+17. Utilizar as habilidades de comunicação durante a assistência: tranquilizar a mulher; acolher de maneira empática e trabalhar a escuta ativa; manter sempre contato visual durante a comunicação; e, caso esteja consciente, informá-la sobre o quadro e permitir que tome decisões(23,27)
+
+18. Promover assistência com equipe multidisciplinar capacitada(21), incluindo capacitação em casos de parada cardiorrespiratória(18,21)
+
+	
+Puerpério imediato e mediato	
+1. Avaliar/monitorar rigorosamente a loquiação de 15 em 15 minutos(26), devido ao risco aumentado de sangramento
+
+2. Após estabilização materna, promover vínculo com neonato(26)
+
+3. Assim que a puérpera estiver estável, estimular a amamentação ou realizar ordenha mecânica, se necessário(26)
+
+4. Observar a incisão cirúrgica quanto a sinais flogísticos e sangramentos(24)
+
+5. Promover cuidados assépticos na manipulação de sondas, drenos e cateteres(24)
+
+6. Promover cuidados de hidratação com a pele e realizar mudança de decúbito periodicamente, se necessário(24)
+
+7. Avaliar condições maternas e orientá-la quanto aos cuidados com neonato(24)
+
+	
+Cuidados com familiares	
+1. Garantir à família que mulher e feto estão recebendo o melhor cuidado possível(23)
+
+2. Respeitar a privacidade de cada membro da família(23)
+
+3. Escutar ativamente preocupações, questionamentos e sentimentos dos familiares(23)
+
+4. Fornecer informações sobre os cuidados de enfermagem realizados(23)
+
+5. Promover o envolvimento familiar nas decisões e cuidados(23)
+
+6. Oferecer suporte/apoio necessários(23)
+
+	
+Cuidados na alta hospitalar ou na sua vigência	
+1. Promover apoio emocional contínuo no período puerperal(27)
+
+2. Promover cuidado emocional/psicológico para puérperas e familiares em casos de perdas fetais/neonatais(22,27)
+
+3. Encaminhar na alta para grupo de apoio para partilhar e falar sobre sua experiência e poder ressignificá-la(27)
+
+	
+
+DISCUSSÃO
+
+Na presente revisão, foram mais frequentes diagnósticos de síndrome HELLP em mulheres na segunda década de vida, semelhante a outros estudos de caso e estudos populacionais(28–31).
+
+Semelhantemente, estudo realizado em Alagoas apontou predomínio de multíparas nos casos identificados(30). Já estudo na Índia apontou maior frequência em primíparas(29).
+
+Quanto à idade gestacional do diagnóstico, observaram-se casos mais comumente no terceiro trimestre gestacional, seguidos por escassos casos no segundo trimestre(32), semelhantemente aos estudos revisados e outros estudos(28,29,31,33). Ressalta-se a importância dos cuidados de enfermagem no pré-natal, a fim de identificar os sinais e intervir precocemente, uma vez que estudo realizado em Alagoas apontou que em todos os casos as mulheres realizaram consultas pré-natais, sendo que 66% realizaram mais de seis consultas, conforme recomendação do Ministério da Saúde, e 44% realizaram consultas, contudo em número inferior ao recomendado(30).
+
+Estudo apontou a associação entre a síndrome HELLP e a síndrome do anticorpo antifosfolípide (SAF), e, nesses casos, aumento de nascimentos prematuros e mortes fetais. Assim, recomenda-se que, na suspeita de uma ou outra condição, sejam feitos o rastreio e o tratamento. O tratamento para SAF melhora o prognóstico neonatal, ao evitar ou melhorar a insuficiência placentária(32).
+
+Vale ressaltar a importância de rastreio dos sintomas, a partir da consulta de enfermagem, quer seja durante o pré-natal ou na admissão da parturiente. A dor abdominal súbita, abrupta e forte intensidade no quadrante superior direito, foi um sintoma descrito por 30%(34) a 78% das mulheres(35). Já o aumento pressórico esteve presente entre 65%(35)e 85%(34) das mulheres. Alterações visuais foram descritas por 20%(34) a 25% das mulheres(29).
+
+Em todos os estudos revisados, realizou-se cesárea de emergência, semelhante aos desfechos apresentados em outros estudos, cuja frequência variou de 88%(30) a 91,1%(31). Apenas estudo realizado na Índia apontou que 84% dos casos evoluíram para parto vaginal(29). Ressalta-se que ultimar o parto de forma imediata e o mais rápida possível contribui para o melhor prognóstico materno e neonatal, sendo indicado como tratamento para os casos, o que contribui para o aumento das cesáreas de emergência neste caso(36).
+
+Indica-se o retardo oportuno do parto, caso a idade gestacional esteja entre 24 e 34 semanas e não haja comprometimento materno e fetal, a fim de realizar a corticoterapia para permitir a maturação pulmonar fetal(36).
+
+Entre os estudos revisados, não houve casos de óbitos neonatais, no entanto nota-se que é um desfecho comum em quadros graves(28–31). Metanálise apontou que a síndrome HELLP aumenta o risco em 1,56 vezes de ter como desfecho natimortos(37).
+
+Entre os nascidos vivos, destaca-se aumento de casos de prematuridade(29–31), com índices entre 46%(29) e 67%(31) dos nascimentos, aumento dos índices de Apgar inferiores a 7(29,30) e aumento dos casos de restrição de crescimento intra-uterino e baixo peso ao nascimento(29–31). Nesse sentido, são necessários cuidados de enfermagem para evitar a prematuridade e, quando não possível, oferecer assistência de enfermagem qualificada e prever a internação desses neonatos em unidades especializadas, a fim de se obter melhores desfechos.
+
+Destaca-se ainda que metanálise apontou que a síndrome HELLP contribuiu para aumento do risco de insuficiência renal aguda em 4,87 vezes(37) e em 3,7 vezes o risco de óbito materno(37). Entre os desfechos dos casos, observaram-se internação em Unidade de Terapia Intensiva(28,33) para monitorização, politransfusões(28,29,33) e necessidade de transplante hepático(33). Devido à criticidade, aponta-se a necessidade de monitorização rigorosa e cuidados intensivos após o parto(32), para garantir melhor desfecho materno.
+
+Destaca-se a necessidade de estender os cuidados para além do tratamento da síndrome, para preservação da saúde mental das mulheres, que pode ser abalada devido à gravidade/criticidade e possíveis perdas. Estudo de revisão apontou alterações de saúde mental em mulheres que tiveram síndrome HELLP, com destaque para aumento da prevalência de depressão, ansiedade e síndrome do estresse pós-traumático, no entanto, devido aos estudos não controlar fatores de confusão, os resultados foram inconclusivos(38). Assim, cabem cuidados relativos à preservação ou restauração da saúde mental dessas mulheres, como citado nos artigos revisados.
+
+Como descrito anteriormente, a síndrome HELLP é uma condição grave que, caso não tratada, pode evoluir para óbito materno. Assim, ao se pensar a assistência, é necessário pensar os possíveis atrasos capazes de impedir a mulher de receber cuidados adequados e necessários. Baseado no modelo teórico dos três atrasos, é necessário repensar a assistência nos três componentes. O primeiro atraso se dá na decisão em procurar o atendimento. Esse primeiro pilar é influenciado pela recusa da mulher e dos familiares(39). Neste sentido, o fortalecimento das práticas educativas e a assistência pré-natal qualificada podem ser fundamentais para evitar o mesmo.
+
+O segundo atraso refere-se ao percurso e ao alcance da mulher aos serviços de saúde, que englobam desde fatores geográficos até transporte e infraestrutura. Já o terceiro atraso consiste em receber cuidados adequados quando há acesso aos serviços de saúde(39). Nesses pontos, é necessário garantir o acesso à saúde em rede, com seus diferentes níveis de atenção. Reforça-se a importância de os serviços de saúde pensarem o fenômeno dos atrasos para analisar soluções para a morbimortalidade materna.
+
+Além disso, é preciso ponderar sobre os nós críticos da assistência. O estudo propõe um plano de cuidados baseado nas evidências, contudo identificamos a relevância: do fortalecimento da assistência na porta de entrada das maternidades, reforçando a metodologia do acolhimento e a classificação de risco como estratégia de qualificação; da garantia de dimensionamento de pessoal adequado, de forma que a presença da enfermeira cuidando de uma mulher com HELLP não inviabilize o cuidado pelas enfermeiras na assistência a outras parturientes; e do fortalecimento das ações de educação permanente com vistas ao cuidado compartilhado interprofissional qualificado.
+
+Ressalta-se a importância da taxonomias para a tomada de decisão do enfermeiro(40). Embora apenas dois estudos da presente revisão descreveram diagnósticos e intervenções e que não há para o quadro diagnósticos ou intervenções específicas, as taxonomias contribuem para o planejamento do cuidado(24), assim como na tomada de decisões efetiva e eficaz diante de uma emergência obstétrica(22), como é o caso da síndrome HELLP.
+
+Contudo, nota-se escassez de estudos que abordem cuidados de enfermagem nos casos de síndrome HELLP, o que compromete a discussão dos achados e consiste em uma limitação deste estudo. Além disso, há poucos estudos publicados sobre o tema na atualidade, o que compromete a comparabilidade dos resultados. Ao mesmo tempo, aponta-se a implicação desta revisão para a prática, uma vez que foram analisados e são apresentados cuidados inerentes à cada fase do ciclo gravídico-puerperal em que se detecta a síndrome.
+
+CONCLUSÃO
+
+A presente revisão apontou a magnitude da síndrome, contudo houve escassez de estudos. Observou-se predominância de estudos de caso, seguidos de estudos descritivos. A revisão possibilitou identificar 39 cuidados de enfermagem voltados à assistência da mulher com síndrome HELLP.
+
+EDITORA ASSOCIADA: Rebeca Nunes Guedes de Oliveira
+
+
+REFERENCES
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Int J Environ Res Public Health
+Journal ID: Int J Environ Res Public Health
+NLM Journal ID: 101238455
+Journal ID: ijerph
+
+International Journal of Environmental Research and Public Health
+
+ISSN: 1661-7827
+EISSN: 1660-4601
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12192985
+PMID: 40566270
+DOI: 10.3390/ijerph22060842
+Article ID: ijerph-22-00842
+Article version: 1
+Subjects: Article
+
+Improving Rural Healthcare in Mobile Clinics: Real-Time, Live Data Entry into the Electronic Medical Record Using a Satellite Internet Connection
+
+https://orcid.org/0000-0003-4471-8885 Smith Daniel Jackson Conceptualization Methodology Investigation Resources Writing – original draft Writing – review & editing Visualization Supervision Project administration Funding acquisition 1 2 *
+https://orcid.org/0000-0002-5709-3047 Mizelle Elizabeth Writing – original draft Writing – review & editing Funding acquisition 2 3
+Ali Nina Writing – original draft Writing – review & editing 1
+Cepeda Valery Formal analysis Investigation Writing – original draft 2 4
+Pearson Tonya Writing – review & editing Supervision 2 5
+Crumbley Kayla Methodology Investigation 2 6 7
+Pimentel Dayana Formal analysis Investigation 2 4
+Herrera Suarez Simón Methodology Project administration 2
+https://orcid.org/0009-0008-5560-0624 Mueller Kenneth Investigation Supervision 2 6
+https://orcid.org/0000-0001-5212-4118 Phan Quyen Supervision Funding acquisition 2 6
+Ferranti Erin P. Conceptualization Investigation Resources Funding acquisition 2 6
+https://orcid.org/0000-0003-2208-3399 Modly Lori A. Conceptualization Methodology Investigation Resources Writing – review & editing Supervision Funding acquisition 2 6 *
+Oriol Nancy Academic Editor
+Williams Mollie Academic Editor
+1 School of Nursing, University at Buffalo, Buffalo, NY 14214, USA; ninaali@buffalo.edu
+2 Farmworker Family Health Program, Atlanta, GA 30322, USA; mizelleel15@ecu.edu (E.M.); valerycepeda0422@gmail.com (V.C.); pearson_t@mercer.edu (T.P.); rogers.kayla501@gmail.com (K.C.); dayanapim.main@gmail.com (D.P.); simonherrera123@gmail.com (S.H.S.); kjmuell@emory.edu (K.M.); qphan@emory.edu (Q.P.); epoe@emory.edu (E.P.F.)
+3 College of Nursing, East Carolina University, Greenville, NC 27858, USA
+4 School of Pharmacy, University of Georgia, Athens, GA 30602, USA
+5 College of Pharmacy, Mercer University, Atlanta, GA 30341, USA
+6 Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA 30322, USA
+7 Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA
+* Correspondence: dsmith55@buffalo.edu or danjaxsn@gmail.com (D.J.S.); lori.a.modly@emory.edu (L.A.M.)
+Electronic publication date: 2025 May 28
+Publication date: 2025 Jun
+Volume: 22
+Issue: 6
+Electronic Location ID: 842
+Received 2025 Mar 7; Revised 2025 May 12; Accepted 2025 May 21
+Copyright: © 2025 by the authors.
+Copyright year: 2025
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: farmworker health, real-time data entry, satellite internet, healthcare accessibility, mobile clinics
+
+Funding: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) K01OH012697 National Institute of Nursing Research (NINR) of the National Institutes of Health (NIH) K01NR021272 Health Resources and Services Administration (HRSA) UK1HP47321-01-00 This research was supported by the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) under award number K01OH012697, the National Institute of Nursing Research (NINR) of the National Institutes of Health (NIH) under award number K01NR021272, and the Health Resources and Services Administration (HRSA) under award number UK1HP47321-01-00. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIOSH, the CDC, NINR, NIH, or HRSA.
+
+Ÿ==============================Ÿ
+The Farmworker Family Health Program (FWFHP) annually supports 600 farmworkers in connectivity-challenged rural areas. Traditional paper-based data collection poses validity concerns, prompting a pilot of direct data entry using tablets and satellite internet to enhance efficiency. The purpose of this article is to describe, using the TIDier checklist, a real-time, live data-entry EMR intervention made possible by satellite internet. Utilizing a customized REDCap database, direct data entry occurred through tablets and satellite internet. Patients received a unique medical record number (MRN) at the mobile health clinic, with an interprofessional team providing care. Medication data, captured in REDCap before the mobile pharmacy visit, exhibited minimal defects at 6.9% of 319 prescriptions. To enhance data collection efficiency, strategies such as limiting free text variables and pre-selecting options were employed. Adequate infrastructure, including tablets with keyboards and barcode scanners, ensured seamless data capture. Wi-Fi extenders improved connectivity in open areas, while backup paper forms were crucial during connectivity disruptions. These practices contributed to enhanced data accuracy. Real-time data entry in connectivity-limited settings is viable. Replacing paper-based methods streamlines healthcare provision, allowing timely collection of occupational and environmental health metrics. The initiative stands as a scalable model for healthcare accessibility, addressing unique challenges in vulnerable communities.
+
+1. Introduction
+
+Health information technology (HIT) has the potential to improve healthcare access, outcomes, and quality [1]. However, due to persistent socioeconomic and geographic disparities, its benefits remain uneven. A digital divide driven by limited technology access and internet use [2] continues to affect underserved populations, particularly along racial, economic, and rural lines [3]. Mobile clinics and telehealth have been used to increase healthcare access for isolated populations [4,5]; however, geographic limitations, like internet availability, are a barrier to mobile clinic implementation [6]. Satellite internet services are advertised to be capable of providing internet access to almost every corner of the globe, including internet speeds that allow uninterrupted services and smooth video consultations [7]. Most current information on the use of satellite internet in healthcare comes from news articles and industry reports, while the limited scholarly literature is outdated. For example, in the early 2000s, satellite internet supported a mobile wellness clinic in frontier and rural Montana [8] and, in 2010, satellite internet was utilized by a field hospital in earthquake disaster zones [9].
+
+In the United States, health disparities are particularly acute among migrant and seasonal farmworkers, which are a predominantly rural, immigrant workforce critical to the nation’s agricultural economy [10]. This population faces unique health risks stemming from occupational exposures [11], language barriers [12,13], geographic isolation [14], immigration-related concerns, and limited access to healthcare due to lack of insurance [15]. The Farmworker Family Health Program (FWFHP) is a long-standing mobile clinic and collaboration that has been providing free healthcare to farmworkers who live and work in rural areas [16]. Delivering healthcare in these remote settings requires not only clinical expertise but also reliable, real-time data systems to document care and inform decision-making. While data collection is often viewed as secondary to direct patient care in resource-limited environments, the FWFHP has recognized that accurate data management is essential for improving health outcomes. As such, the program has prioritized strengthening its data infrastructure to better capture and respond to the unique health needs of this underserved workforce.
+
+In 2019, the FWFHP staff implemented a relational database to collect electronic medical record (EMR) data for participants of the programs [17]. However, due to the internally perceived limitations of field-based data collection, the program was completing dual data entry, once on a paper form, and then finally into the REDCap database. The intervention, described here, was developed to overcome these data collection challenges. The aim of this methodological report is to describe the development, implementation, and evaluation of a real-time, live data-entry process using satellite internet in a rural mobile health clinic setting. Specifically, we seek to answer the following guiding question: Can satellite-enabled, real-time electronic medical record (EMR) data entry improve workflow efficiency and data accuracy in connectivity-challenged mobile clinic environments? We will also describe the equipment needed for direct data entry and provide an example of data tracking for the pharmacy services of the FWFHP mobile health clinic.
+
+2. Materials and Methods (TIDieR Checklist 1-11)
+
+The intervention will be described using the TIDieR checklist, a 12-item Template for Intervention Description and Replication [18]. TIDieR is an extension of the Consolidated Standards of Reporting Trials [19] and Standard Protocol Items statements [20] and was developed to improve the quality of reporting on interventions [21].
+
+2.1. Why
+
+Historically, data collection in rural public health endeavors has been completed using spreadsheets; the use of relational databases is a relatively new method for smaller public health projects [17]. For occupational health clinicians, this poses an interesting conundrum for ensuring data validity when working with rural workers in settings that may lack broader internet connectivity [22]. Real-time, live data entry is critical for syncing patient and medication data across multiple devices and maintaining the functionality of healthcare systems in remote or outdoor environments.
+
+2.2. What
+
+We planned and implemented real-time, live data entry using a satellite internet connection for a rural, mobile health clinic serving migrant farmworkers across southern Georgia, United States.
+
+2.3. Materials
+
+The technological infrastructure required for this project was a combination of both internet access technology and point-of-care data entry technology. The internet access technology consisted of Starlink© satellite internet [23]. Data-entry technology consisted of laptop computers, tablets, Bluetooth keyboards, a portable document scanner, barcode scanners, and an EMR developed prior to the intervention year [17]. A 240 Wh fully charged mobile battery was available to provide backup power supply for satellite internet and data-entry technology if needed. Additionally, mobile solar panels were used for on-site battery charging. A complete list of equipment, quantities, and locations within the mobile clinic can be found in Table 1.
+
+2.4. Procedures
+
+During the evenings of the 2-week-long program, medical clinics are set up on farms where the migrant workers both live and work and provide episodic medical care (e.g., acute care visits, physical therapy visits, and prescriptions provided by the pharmacy). From 2021 to 2023, all data were collected on paper and subsequently entered into the REDCap [24,25] as the EMR. A timeline of the data-entry procedures for the FWFHP can be found in Figure 1. This process was error-prone as there were often delays in data entry and a “mad dash” to ensure all data were entered before the conclusion of the 2 weeks, often on the last day of the program. To facilitate data collection and analysis, all instances of patient encounters within our database were systematically assigned a medical record number (MRN). Patients were assigned an MRN in the format of YYFXXX, with YY representing the current year, F representing a predetermined code for each farm (that matched the code label for the farm identification variable in REDCap), and XXX being a unique identifying number. This unique identifying number was assigned as farmworkers checked into the clinic and went in order from “001” to a possible “999”. To reduce transcription errors and improve data integrity, the REDCap system was programmed to prepopulate commonly used variables such as vital sign CPT codes and screening procedures with default values. All ICD-10 diagnosis codes were defaulted to “no” so that clinicians only needed to actively select “yes” for relevant diagnoses. Additionally, REDCap’s field validation features, including preset value ranges and required fields, were used to flag incomplete or implausible entries in real time, thereby supporting accurate and consistent data collection throughout the program.
+
+2.4.1. Data Security and Procedures
+
+All patient data were collected and stored using REDCap, a secure and HIPAA-compliant data management platform designed for handling sensitive health information [24,25]. The REDCap system was hosted in a secure, restricted-access environment that met healthcare data protection standards. Access to the database was limited to authorized users through individual, password-protected accounts with role-based permissions. User authentication was managed through institutional login systems, and audit trails were maintained to document all data manipulation and export activities.
+
+2.4.2. Clinical Workflow
+
+During mobile clinics for farmworkers, the first interaction with the patient occurs in triage, where upon consenting, vital signs and presenting problems are assessed and recorded by the nursing team. These data are used to triage patients as they move throughout the clinic to prioritize the care level with (1) a dental care provider, (2) a mental health provider, (3) a nurse practitioner, or (4) a physical therapist and so that patients are able to seek care at multiple stations as resources permit. Given that medications can be prescribed to a patient at multiple time points throughout the clinic, the final clinical station that patients pass through is the pharmacy. Farmworkers who have no presenting problem and only wish to have their vitals taken progress through the triage stations and then may leave the clinic. All stations are set up outdoors on the farm property, and the distance between each ranges from 10 feet to 200 feet. An overview of the clinical workflow of the FWFHP can be found in Figure 2. Data are input at each clinical station as workers make their way through the mobile clinic. Additionally, there is a need for data to be reviewed in “real time” as farmworkers make their way through the clinic, which was achieved through the implementation of this intervention.
+
+2.5. Who Provided
+
+The interprofessional program provides health screenings with student nurses, medical visits with student nurse practitioners, musculoskeletal evaluations with student physical therapists, oral health visits with student dental hygienists, mental health support with student social workers, and medication counseling and dispensing through a student-led mobile pharmacy. Allied health students participating in the program include pre-licensure nursing (i.e., students becoming registered nurses), post-licensure nursing (i.e., students becoming nurse practitioners), physical therapy, psychology, dental hygiene, and pharmacy; volunteers make up the Spanish–English interpreters and data management team. All clinicians and clinician trainees completed one-hour video-based REDCap training before working in the mobile clinics, followed by an additional one-hour in-person orientation focused on data-entry procedures and role expectations. During live data collection, on-site informatics support by the data management team was available and provided real-time troubleshooting and assistance to ensure smooth and accurate data entry.
+
+2.6. How
+
+The real-time data-entry Starlink© satellite internet made it possible to conduct real-time data entry, by having live Wi-Fi available on all iPads simultaneously. Starlink Roam is a satellite internet service offered by SpaceX [23], which uses low-Earth-orbit satellites to provide high-speed, low-latency internet access worldwide. The “roam” service specifically allows users to access the network while traveling, whether stationary or in motion.
+
+2.7. Where
+
+The FWFHP is based out of Colquitt County, GA, which is designated as rural by the Office of Management and Budgets [26]. This mobile clinic provides clinical care to approximately 600 migrant farmworkers and their families annually [16].
+
+2.8. When and How Much
+
+These intensive mobile clinics run for 2 weeks in June every year. This specific intervention with real-time data entry was first implemented in June 2023 and has been maintained since.
+
+2.9. Tailoring
+
+In the mobile pharmacy, medications were organized as “fast movers” or “non-fast movers”. “Fast movers” were identified based on historical dispensing of commonly used over-the-counter medications such as ibuprofen, acetaminophen, menthol-based muscle rub creams, multivitamins, and lubricant eye drops. “Fast movers” were prelabeled with generic directions for dispensing efficiency, and dispensing was logged using paper records due to limited QR scanners. After the conclusion of the program, the paper records for the “fast movers” were converted electronically into the REDCap system for accuracy. “Non-fast movers” required filling and dispensing by the mobile pharmacy. Filling included typing a prescription label in Spanish using label printers, dispensing the medication, and having a student pharmacist under the supervision of a licensed pharmacist double check for validity. Each “non-fast mover” prescription was scanned into REDCap using our drug- and dose-specific QR codes for the patient. Barcode scanners ensured a closed-loop system for medication administration by corresponding with the patient’s EMR [27].
+
+The original FWFHP database was developed and first implemented in 2019 [17]. This process led to the identification of common diagnoses made by clinicians in the fields and increased capturing of procedure and evaluation and management (E&M) codes by placing them in the field-based EMR. REDCap allows for complete customization of data collection procedures, including variable coding (i.e., 0 = no and 1 = yes), variable naming, variable type (i.e., select-all-that-apply, single options, and free text), pre-selection of variable values, and branching logic to only allow for the selection of variables under specified criteria [24,25]. To facilitate a live-field-based data collection, we refined our original database from 2019 to prefill variable responses for values that were likely to not change. For example, Current Procedural Terminology codes for vital signs and health screening were defaulted as affirmative. International Classification of Diseases-10 codes were defaulted as negative, which meant clinicians needed only change the selection from “no” to “yes” for the diagnoses made. The database was also updated to reflect the NIH and Emory Nell Hodgson Woodruff School of Nursing’s common data elements [17,28], which had not been considered in the original design of the database.
+
+2.10. Modifications
+
+The intervention was further upgraded in 2024 by (1) adding 40 additional computer tablets so each clinician could connect to the internet and enter in data real time, and (2) adding a mesh Wi-Fi network to ensure adequate internet access across the mobile clinic.
+
+2.11. How Well (Planned)
+
+The fidelity of the intervention was assessed by data defects, defined as prescriptions that were not properly logged in REDCap, which led to missing prescriptions and uncertainty about whether a medication was dispensed to the patient. Data defects were calculated using the number of prescription discrepancies divided by the number of prescriptions entered into the data system, where discrepancies are variances in the number of prescriptions compared to what was recorded in the system. For example, if an individual had 4 total prescriptions listed in their chart, but only 2 were recorded or scanned into REDCap, this would be counted as 2 defects due to 2 missed/unknown prescriptions. REDCap’s built-in reporting tools were used to identify and quantify these discrepancies, allowing for efficient tracking of defect rates across the intervention period.
+
+3. Results (TIDieR Checklist 12)
+
+How Well (Actual)
+
+Out of the 319 prescriptions, only 6.9% (n = 22) were reported as data defects. Factors that may have contributed to data defects include user training, the data collection process, and the number of QR scanners. Pharmacy students rotated daily through numerous roles such as patient counseling, medication filling, label typing, or barcode scanning. Due to daily rotation, there was no consistency in roles; thus, there was the potential for a knowledge gap in appropriate barcode scanning. “Fast mover” data collection was handwritten and then manually converted into the REDCap system due to the high volume of “fast mover” dispensing. This two-step process may have resulted in human error due to difficulty reading handwriting or missing prescription data (omitted name, MRN, medication). Another factor that may have contributed to data defects was that the QR scanner was only used inside the mobile pharmacy to fill “non-fast mover” prescriptions.
+
+4. Discussion
+
+The rural setting of the FWFHP highlights the importance of reliable internet connectivity to support field-based healthcare tools. Wi-Fi extenders were instrumental in expanding network coverage to open areas, ensuring uninterrupted access to EMRs and other digital tools [29]. In the event of connectivity interruptions from storms, paper forms were used. Incorporating robust infrastructure, including backup power sources and offline-capable software, can further enhance resilience during adverse weather conditions [30]. While satellite internet users currently report inconsistent throughput and experience time delays, the technology is rapidly improving as more satellite internet providers enter the market [31]. Notably, SpaceX has announced plans to expand its Starlink network to a mega-constellation of 12,000–30,000 satellites aimed at delivering global satellite internet coverage [32]. As of December 2022, more than 3500 satellites had already been deployed, with over one million user terminals produced and service extended to at least 40 countries worldwide [33]. This rapid expansion of low-Earth-orbit satellite infrastructure holds promise for improving connectivity in even the most remote clinical environments.
+
+The local success of this real-time data-entry intervention builds upon the foundational work of mobile health programs that have sought to address documentation challenges in rural and resource-limited settings. Traditionally, many mobile clinics have relied on paper-based data collection methods, with subsequent transcription into electronic systems post-visit. This asynchronous approach often introduces delays and increases the risk of transcription errors. For instance, Shahbodaghi et al. [34] highlighted the limitations of paper-based documentation, noting challenges in data accuracy and timeliness. They recommended standardizing the documentation process to reduce errors, which aligns with our intervention tailoring to include pre-determined variable coding, pre-selection of variable values, and application of branching logic to only allow for the selection of variables under specified criteria. Furthermore, seamless tracking of changes over time in the EMR is a capability particularly beneficial in coordinating care for migrant populations. In rural areas, adult farmworkers often access care individually based on their work schedules and geographic proximity to the clinic [12,13]. The inclusion of a farm identification variable and the current year in adult MRNs linked patients to specific locations. This allowed for streamlined care delivery for a geographically dispersed population when workers were referred to the brick-and-mortar migrant health clinic for further care. In addition to improving care coordination, this approach also establishes the foundation for longitudinal data collection and analysis, enabling the program to track health trends and outcomes over time across multiple locations and patient visits.
+
+In the pharmacy component of the FWFHP, technology further enabled a mobile clinic team to provide streamlined and accurate care. We were able to link patients, prescriptions, and diagnosis codes, facilitating data analysis for quality improvement. This was previously not possible using Excel tracking. The new data management process improved the workflow and decreased the entry time into the REDCap system. The use of QR barcodes and scanner technology streamlined real-time data entry into REDCap, with a 6.9% defect rate. A recent systematic review and meta-analysis showed that across pharmacy settings, there is a 1.6% defect rate in prescription filling [35]. An important operational challenge observed during the implementation of real-time data entry was the variability introduced by daily staff and student rotations. Students and volunteers frequently moved between roles such as patient check-in, triage, medication filling, and barcode scanning, which meant that few individuals performed the same task consistently across multiple clinic sessions. While this rotation provided valuable educational experiences, it also introduced inconsistency in data-entry practices. Limited time for role-specific training and frequent role transitions tasks [36] likely contributed to the 6.9% defect rate observed in pharmacy data. Variability and lack of continuity are known risks in systems that rely on both electronic and paper-based documentation. Transitioning to a fully electronic system, supported by expanded access to barcode scanners, may help address these challenges by reducing reliance on handwritten records [27] and improving workflow standardization in rural settings. Future efforts should include structured, role-specific training [37] and daily refresher sessions [38] to promote data consistency between rotating staff and students and reduce workflow interruptions.
+
+While the intervention demonstrated the feasibility of real-time data entry in connectivity-challenged rural settings, its long-term sustainability requires a careful consideration of ongoing costs, infrastructural maintenance, and operational scalability. The initial investment in satellite internet hardware, Wi-Fi mesh routers, tablets, barcode scanners, and backup power supplies represents a significant upfront cost for programs operating on limited budgets. The initial start-up budget for this project was USD 40,000, largely driven by the number of tablet computers needed. Ongoing subscription fees for the satellite internet service and the need to periodically replace or upgrade hardware further add to the financial burden. Additionally, the successful deployment of this model depends on the availability of trained personnel to manage both clinical care and data systems, as well as informatics support for troubleshooting in the field. Despite these challenges, the scalability of the intervention is promising. As satellite internet technology becomes more affordable and widely available, and as digital health tools continue to advance, this model could be adapted for use in other mobile health programs serving rural and underserved populations. Programs seeking to reduce costs may consider leveraging shared equipment across partner organizations, securing institutional or philanthropic funding for initial infrastructural investments, and negotiating group purchasing agreements or non-profit pricing for satellite internet subscriptions and hardware.
+
+Limitations
+
+While this intervention demonstrated the feasibility of real-time data entry in a rural mobile health setting, several limitations should be noted. First, the data defect analysis was limited to pharmacy data and may not reflect potential errors in other clinical data fields. Second, staff and student rotations introduced variability in data-entry practices, which could have affected consistency. Additionally, this study was conducted in a single program over a limited two-week period, which may limit generalizability to other settings or larger-scale implementations. Future research should explore the impact of sustained use over multiple program cycles, evaluate the effectiveness of structured training protocols, and assess cost-effectiveness compared to other data collection models. Expanding this model to other mobile clinics and documenting implementation outcomes across diverse geographic regions will be important next steps to validate the scalability and long-term sustainability.
+
+5. Conclusions
+
+The implementation of real-time, live data entry using satellite internet and integrated digital tools represents a scalable and effective model for enhancing healthcare delivery in connectivity-challenged rural settings. By leveraging a customized REDCap database, barcode scanners, Wi-Fi extenders, and backup power sources, the initiative successfully addressed the limitations of traditional paper-based documentation, reducing errors and streamlining clinical workflows. For mobile clinics operating in rural areas with inconsistent or no internet access, this approach offers a transformative solution. By reducing the reliance on paper records and improving the accuracy of patient data collection, mobile teams can ensure a continuity of care, particularly for migrant populations who require seamless health record tracking across multiple visits and locations. Expanding this model to other mobile clinics could significantly enhance access to care in rural and underserved communities. As satellite internet technology advances and digital tools become more widely available, mobile clinics can achieve greater efficiency, improve patient outcomes, and strengthen healthcare equity by ensuring that even the most geographically isolated populations receive high-quality, data-driven care.
+
+Acknowledgments
+
+The authors would like to acknowledge all farmworkers who produce our food. Remember, if you ate today, thank a farmworker!
+
+Author Contributions
+
+Conceptualization, D.J.S., E.P.F. and L.A.M.; methodology, D.J.S., K.C., S.H.S. and L.A.M.; formal analysis, V.C. and D.P.; investigation, D.J.S., K.C., K.M., V.C., D.P., K.M., E.P.F. and L.A.M.; resources, D.J.S., E.P.F. and L.A.M.; writing—original draft preparation, D.J.S., V.C., N.A. and E.M.; writing—review and editing, D.J.S., E.M., L.A.M. and T.P.; visualization, D.J.S.; supervision, D.J.S., Q.P. and K.M. and T.P.; project administration, D.J.S. and S.H.S.; funding acquisition, D.J.S., E.M., Q.P., E.P.F. and L.A.M. The article-processing charge funding was acquired by Q.P. and L.A.M. All authors have read and agreed to the published version of the manuscript.
+
+Institutional Review Board Statement
+
+This study did not involve human or animal subjects. The development and refinement of the EMR presented here have previously been determined to fall under the category of quality improvement by the Emory University Institutional Review Board (IRB) and were thus exempt from IRB oversight. As such, ethical review and approval were not required.
+
+Informed Consent Statement
+
+Not applicable.
+
+Data Availability Statement
+
+Data are available upon reasonable request from the corresponding author.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Abbreviations
+
+The following abbreviations are used in this manuscript: FWFHP	Farmworker Family Health Program	
+EMR	Electronic Medical Record	
+MRN	Medical Record Number	
+TIDieR	Template for Intervention Description and Replication	
+
+Figure 1 Timeline of FWFHP data collection methods.
+
+Figure 2 Clinical workflow of the FWFHP.
+
+ijerph-22-00842-t001_Table 1 Table 1 List of technology infrastructure required, quantity, and approximate location to facilitate real-time, field-based data entry.
+
+Internet Access Technology	
+Equipment	Quantity	Approximate Location	
+Satellite	1	Unobstructed view of sky	
+Mobile Base	1	Unobstructed view of sky	
+Internet Modem	1	Unobstructed view of sky	
+Starlink© Cable (50 ft)	1	Connects modem and satellite	
+AC Power Cable (6 ft)	1	AC power to Starlink	
+Extension Cords (50 ft)	2	AC power to mesh routers	
+Wi-Fi Mesh Network Routers #	4	1 at triage, nurse practitioner treatment area, physical therapy treatment area, and pharmacy	
+Battery Packs	5	1 powering internet modem and 1 powering each of the Wi-Fi mesh network routers. In areas without electricity	
+Point-of-Care Data-Entry Technology	
+Equipment	Quantity	Approximate Location	
+Laptop Computers	4	2 pharmacy, 2 data managers: mobile	
+Tablet Computers with Electronic Pencil *	4	Check-in	
+20	Triage, screening stations	
+2	Check-out	
+Tablet Computers with Bluetooth Keyboards *	15	Nurse practitioner treatment area	
+10	Physical therapy treatment area	
+2	Mental health treatment area	
+5	Clinic preceptors	
+Portable Document Scanner	1	Pharmacy	
+Barcode Scanner	2	Pharmacy	
+* These numbers were increased in 2024 through the addition of 40 extra tablets that could be used for this intervention. # Wi-Fi mesh routers were added when the intervention was modified in 2024.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
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+7. SARAH Starlink for Healthcare Onwave 2024 Available online: https://www.onwave.com/starlink-for-the-healthcare-sector/ (accessed on 13 February 2025)
+8. Stratton T.P. Williams R.G. Meine K.L. Developing a Mobile Pharmacist-Conducted Wellness Clinic for Rural Montana Communities J. Am. Pharm. Assoc. 2005 45 390 399 10.1331/1544345054003723 15991761
+9. Finestone A.S. Levy G. Bar-Dayan Y. Telecommunications in Israeli Field Hospitals Deployed to Three Crisis Zones Disasters 2014 38 833 845 10.1111/disa.12074 25196339
+10. Carmona Y. Parent M.C. Perceptions from the Public on Farmworker Contributions to the U.S. Economy and Attitudes toward Farmworkers Cultur. Divers. Ethnic Minor. Psychol. 2025 31 325 332 10.1037/cdp0000640 38300596
+11. Moyce S.C. Schenker M. Migrant Workers and Their Occupational Health and Safety Annu. Rev. Public Health 2018 39 351 365 10.1146/annurev-publhealth-040617-013714 29400993
+12. Harwell E.L. LePrevost C.E. Cofie L.E. Lee J.G.L. Community Health Workers’ Role in Addressing Farmworker Health Disparities J. Agromed. 2022 27 391 401 10.1080/1059924X.2022.2040069 PMC9395548 35168470
+13. Soto S. Yoder A.M. Aceves B. Nuño T. Sepulveda R. Rosales C.B. Determining Regional Differences in Barriers to Accessing Health Care Among Farmworkers Using the National Agricultural Workers Survey J. Immigr. Minor. Health 2023 25 324 330 10.1007/s10903-022-01406-9 36319879 PMC9988993
+14. Rural Health Information Hub Available online: https://www.ruralhealthinfo.org/topics/rural-health-disparities (accessed on 13 February 2025)
+15. Smith D. Mutic A. Mac V.V.T. Hertzberg V.S. McCauley L.A. Analyzing the Predictors of Health Care Utilization in the Agricultural Worker Population Using Decision Tree Analysis: Does Language Matter? Public Health Nurs. 2021 38 56 63 10.1111/phn.12826 33107059
+16. Connor A. Layne L. Thomisee K. Providing Care for Migrant Farm Worker Families in Their Unique Sociocultural Context and Environment J. Transcult. Nurs. 2010 21 159 166 10.1177/1043659609357631 20301816
+17. Modly L.A. Smith D.J. The Need for Data Management Standards in Public Health Nursing: A Narrative Review and Case Study Public Health Nurs. 2022 39 1027 1033 10.1111/phn.13066 35263460
+18. Hoffmann T.C. Glasziou P.P. Boutron I. Milne R. Perera R. Moher D. Altman D.G. Barbour V. Macdonald H. Johnston M. Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide BMJ 2014 348 g1687 10.1136/bmj.g1687 24609605
+19. Merkow R.P. Kaji A.H. Itani K.M.F. The CONSORT Framework JAMA Surg. 2021 156 877 10.1001/jamasurg.2021.0549 33825818 PMC8822473
+20. Chan Z. Fung Y. Chien W. Bracketing in Phenomenology: Only Undertaken in the Data Collection and Analysis Process Qual. Rep. 2013 18 1 9 10.46743/2160-3715/2013.1486
+21. Cao L. Liu W. Yao L. He W. Yin Z. Li K. Tam W. Evaluating Intervention Reporting in Nursing Journal RCTs Using the TIDieR Checklist: A Cross-Sectional Study J. Adv. Nurs. 2025 epub ahead of print 10.1111/jan.16744 PMC12371817 39801126
+22. Lythreatis S. Singh S.K. El-Kassar A.-N. The Digital Divide: A Review and Future Research Agenda Technol. Forecast. Soc. Chang. 2022 175 121359 10.1016/j.techfore.2021.121359
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+25. Harris P.A. Taylor R. Minor B.L. Elliott V. Fernandez M. O’Neal L. McLeod L. Delacqua G. Delacqua F. Kirby J. The REDCap Consortium: Building an International Community of Software Platform Partners J. Biomed. Inform. 2019 95 103208 10.1016/j.jbi.2019.103208 31078660 PMC7254481
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+27. Küng K. Aeschbacher K. Rütsche A. Goette J. Zürcher S. Schmidli J. Schwendimann R. Effect of Barcode Technology on Medication Preparation Safety: A Quasi-Experimental Study Int. J. Qual. Health Care 2021 33 mzab043 10.1093/intqhc/mzab043 33783482
+28. Corwin E.J. Moore S.M. Plotsky A. Heitkemper M.M. Dorsey S.G. Waldrop-Valverde D. Bailey D.E. Docherty S.L. Whitney J.D. Musil C.M. Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis J. Nurs. Scholarsh. 2017 49 249 258 10.1111/jnu.12287 28231416 PMC5426501
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+30. Peirow S. Razi Astaraei F. Saifoddin A.A. Yousefi H. Sustainable Backup Power Supply of a Hospital by Designing a Hybrid Renewable Energy System J. Renew. Energy Environ. 2022 9 48 63 10.30501/jree.2022.304704.1257
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+34. Shahbodaghi A. Moghaddasi H. Asadi F. Hosseini A. Documentation Errors and Deficiencies in Medical Records: A Systematic Review J. Health Manag. 2024 26 351 368 10.1177/09720634241229545
+35. Um I.S. Clough A. Tan E.C.K. Dispensing Error Rates in Pharmacy: A Systematic Review and Meta-Analysis Res. Soc. Adm. Pharm. 2024 20 1 9 10.1016/j.sapharm.2023.10.003 37848350
+36. Fahrudi E. Lumadi S.A. Maria L. Relationship between the Perception of Employee Rotation and Nurse Performance during the COVID-19 Pandemic J. Plb. Nurs. Stud. 2023 2 111 117 10.55048/jpns69
+37. Robertson S.T. Rosbergen I.C.M. Brauer S.G. Grimley R.S. Burton-Jones A. Addressing Complexity When Developing an Education Program for the Implementation of a Stroke Electronic Medical Record (EMR) Enhancement BMC Health Serv. Res. 2023 23 1301 10.1186/s12913-023-10314-z 38001487 PMC10675965
+38. Faris N. Saliba M. Tamim H. Jabbour R. Fakih A. Sadek Z. Antoun R. El Sayed M. Hitti E. Electronic Medical Record Implementation in the Emergency Department in a Low-Resource Country: Lessons Learned PLoS ONE 2024 19 e0298027 10.1371/journal.pone.0298027 38427653 PMC10906867
diff --git a/corpus/healthcare/text/83ad1d68cad90e8e.txt b/corpus/healthcare/text/83ad1d68cad90e8e.txt
new file mode 100644
index 0000000000000000000000000000000000000000..293f2b09e2129ebb17a41c23b74311f9fb6bf059
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+++ b/corpus/healthcare/text/83ad1d68cad90e8e.txt
@@ -0,0 +1,60 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Ann Nucl Med
+Journal ID: Ann Nucl Med
+NLM Journal ID: 8913398
+
+Annals of Nuclear Medicine
+
+ISSN: 0914-7187
+EISSN: 1864-6433
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13283140
+PMID: 42183992
+DOI: 10.1007/s12149-026-02238-5
+Article ID: 2238
+Article version: 1
+Subjects: Correction
+
+Correction: Biochemical failure after radical prostatectomy with PSA ≤ 1 ng/mL: prediction of PSMA-positive metastatic disease
+
+Santo Giulia giulia.santo@unicz.it
+1
+Rosarno Helena 2
+Restuccia Antonino 2
+Cascini Giuseppe Lucio 3
+Grillone Francesco 4
+http://orcid.org/0000-0003-4664-1965 Cicone Francesco cicone@unicz.it
+1 2
+1 https://ror.org/0530bdk91 grid.411489.1 0000 0001 2168 2547 Department of Experimental and Clinical Medicine, “Magna Graecia” University of Catanzaro, Campus “Salvatore Venuta”, Viale Europa, Catanzaro, 88100 Italy
+2 Nuclear Medicine Unit, “Mater Domini” Hospital, “Renato Dulbecco” University Hospital, Catanzaro, Italy
+3 https://ror.org/04z08z627 grid.10373.36 0000 0001 2205 5422 Department of Medicine and Heath Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, Italy
+4 Medical Oncology Unit, “Pugliese-Ciaccio” Hospital, “Renato Dulbecco” University Hospital, Catanzaro, Italy
+Electronic publication date: 2026 May 25
+Print publication date: 2026
+Volume: 40
+Issue: 7
+First page: 844
+Last page: 844
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Biochemical failure after radical prostatectomy with PSA ≤ 1 ng/mL: prediction of PSMA-positive metastatic disease 40 5 15 1 2026 521 531 Annals of Nuclear Medicine 10.1007/s12149-026-02153-9 PMC13124769 41537920
+issue-copyright-statement: © The Japanese Society of Nuclear Medicine 2026
+
+Ÿ==============================Ÿ
+Correction to: Annals of Nuclear Medicine (2026) 40:521–531
+
+10.1007/s12149-026-02153-9
+
+In this article, the caption for Fig. 3(d) should be replaced with: ‘A 70-year-old patient with persistent disease 4 weeks after RP (PSA = 1.0 ng/mL). PSMA PET showed bone disease in the left fifth rib, left hip, and right hemibody of L3 (red arrow).’
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
diff --git a/corpus/healthcare/text/84b9cb987cf55632.txt b/corpus/healthcare/text/84b9cb987cf55632.txt
new file mode 100644
index 0000000000000000000000000000000000000000..84809b408cbfbcd3c818ec36ee540c6202237cf0
--- /dev/null
+++ b/corpus/healthcare/text/84b9cb987cf55632.txt
@@ -0,0 +1,70 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Genes (Basel)
+Journal ID: Genes (Basel)
+NLM Journal ID: 101551097
+Journal ID: genes
+
+Genes
+
+EISSN: 2073-4425
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13492001
+PMID: 42622443
+DOI: 10.3390/genes17080972
+Article ID: genes-17-00972
+Article version: 1
+Subjects: Retraction
+
+RETRACTED: Wigner et al. The Impact of Chronic Mild Stress and Agomelatine Treatment on the Expression Level and Methylation Status of Genes Involved in Tryptophan Catabolic Pathway in PBMCs and Brain Structures. Genes 2020, 11, 1093
+
+Wigner Paulina 1
+https://orcid.org/0000-0002-0730-4491 Synowiec Ewelina 1
+https://orcid.org/0000-0002-1340-6355 Jóźwiak Paweł 2
+https://orcid.org/0000-0002-5146-5225 Czarny Piotr 3
+Białek Katarzyna 1
+https://orcid.org/0000-0002-7838-4097 Bijak Michal 4
+https://orcid.org/0000-0001-6052-3557 Szemraj Janusz 3
+https://orcid.org/0000-0001-5709-0359 Gruca Piotr 5
+https://orcid.org/0000-0003-1282-3939 Papp Mariusz 5
+https://orcid.org/0000-0001-8385-7744 Sliwinski Tomasz 1 *
+1 Laboratory of Medical Genetics, Faculty of Biology and Environmental Protection, University of Lodz, 90-236 Lodz, Poland; paulina.wigner@gmail.com (P.W.); ewelina.synowiec@biol.uni.lodz.pl (E.S.); biaalek.k@gmail.com (K.B.)
+2 Department of Cytobiochemistry, Faculty of Biology and Environmental Protection, University of Lodz, 90-236 Lodz, Poland; pawel.jozwiak@biol.uni.lodz.pl
+3 Department of Medical Biochemistry, Medical University of Lodz, 92-216 Lodz, Poland; piotr.czarny@umed.lodz.pl (P.C.); janusz.szemraj@umed.lodz.pl (J.S.)
+4 Biohazard Prevention Centre, Faculty of Biology and Environmental Protection, University of Lodz, 90-236 Lodz, Poland; michal.bijak@biol.uni.lodz.pl
+5 Institute of Pharmacology, Polish Academy of Sciences, 31-343 Krakow, Poland; gruca@if-pan.krakow.pl (P.G.); nfpapp@cyfronet.pl (M.P.)
+* Correspondence: tomsliw@biol.uni.lodz.pl
+Electronic publication date: 2026 Aug 19
+Publication date: 2026 Aug
+Volume: 17
+Issue: 8
+Electronic Location ID: 972
+Received 2026 May 14; Accepted 2026 May 26
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Retraction of: RETRACTED: The Impact of Chronic Mild Stress and Agomelatine Treatment on the Expression Level and Methylation Status of Genes Involved in Tryptophan Catabolic Pathway in PBMCs and Brain Structures 11 9 18 9 2020 1093 Genes 10.3390/genes11091093 PMC7563711 32962062
+
+Ÿ==============================Ÿ
+The journal retracts the article titled, “The Impact of Chronic Mild Stress and Agomelatine Treatment on the Expression Level and Methylation Status of Genes Involved in Tryptophan Catabolic Pathway in PBMCs and Brain Structures” [1], cited above.
+
+Following publication, concerns were brought to the attention of the Editorial Office regarding the integrity of images presented in this article [1].
+
+In accordance with the journal’s standard procedures, the Editorial Office and Editorial Board conducted an investigation that identified indications of inappropriate image editing and duplication within Figure 5. Although the authors cooperated with the investigation, the explanations and supporting materials provided were not deemed sufficient by the Editorial Board to resolve the identified concerns. Consequently, the Editorial Board has lost confidence in the reliability of the reported findings and has decided to retract this publication.
+
+This retraction was approved by the Editor-in-Chief of the journal Genes.
+
+The authors have been informed of this retraction and have indicated their disagreement with this decision.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+Reference
+
+1. Wigner P. Synowiec E. Jóźwiak P. Czarny P. Białek K. Bijak M. Szemraj J. Gruca P. Papp M. Sliwinski T. RETRACTED: The Impact of Chronic Mild Stress and Agomelatine Treatment on the Expression Level and Methylation Status of Genes Involved in Tryptophan Catabolic Pathway in PBMCs and Brain Structures Genes 2020 11 1093 10.3390/genes11091093 32962062 PMC7563711
diff --git a/corpus/healthcare/text/8d60fb15cc3972c0.txt b/corpus/healthcare/text/8d60fb15cc3972c0.txt
new file mode 100644
index 0000000000000000000000000000000000000000..aa2305e097127f4dc0669f682aabf5e48a5fb573
--- /dev/null
+++ b/corpus/healthcare/text/8d60fb15cc3972c0.txt
@@ -0,0 +1,72 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Plant Sci
+Journal ID: Front Plant Sci
+NLM Journal ID: 101568200
+Journal ID: Front. Plant Sci.
+
+Frontiers in Plant Science
+
+EISSN: 1664-462X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13352475
+PMID: 42433890
+DOI: 10.3389/fpls.2026.1880531
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Synthetic plant disease image generation to improve segmentation tasks in low-resource settings
+
+Cooper Elliott Data curation Visualization Validation Methodology Conceptualization Supervision Project administration Writing – original draft Software Investigation Formal analysis Resources Writing – review & editing Funding acquisition
+Hartley Zane Writing – original draft Resources Funding acquisition Writing – review & editing Visualization Formal analysis Software Conceptualization Validation Project administration Data curation Investigation Supervision Methodology
+French Andrew * Data curation Software Investigation Resources Conceptualization Methodology Visualization Writing – original draft Project administration Validation Writing – review & editing Funding acquisition Supervision Formal analysis
+School of Computer Science, University of Nottingham , Nottingham ,  United Kingdom
+* Correspondence: Andrew French, andrew.p.french@nottingham.ac.uk
+Electronic publication date: 2026 Jun 25
+Publication date: 2026
+Volume: 17
+Electronic Location ID: 1880531
+Received 2026 May 13; Accepted 2026 May 22
+Copyright: Copyright © 2026 Cooper, Hartley and French.
+Copyright year: 2026
+Copyright holder: Cooper, Hartley and French
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Synthetic plant disease image generation to improve segmentation tasks in low-resource settings 17 8 5 2026 1812323 Frontiers in Plant Science 10.3389/fpls.2026.1812323 PMC13194994 42179483
+Keywords: ControlNet, leaf segmentation, low-rank adaptation, low-resource learning, plant disease detection, semantic segmentation, stable diffusion, synthetic data
+Figure count: 0
+Table count: 1
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Technical Advances in Plant Science
+
+Ÿ==============================Ÿ
+There was a mistake in Table 4 as published. Only the two “Real+Stable Diffusion” columns should be bolded, correctly identifying the best performance. The corrected Table 4 appears below.
+
+Table 4 Per-class dice and IoU segmentation results.
+
+Class	Real	Blender	Real + blender	Stable diffusion	Real + stable diffusion	
+Dice	IoU	Dice	IoU	Dice	IoU	Dice	IoU	Dice	IoU	
+Background	0.95	0.90	0.72	0.56	0.95	0.90	0.83	0.71	0.95	0.90	
+Healthy	0.82	0.69	0.52	0.35	0.69	0.53	0.58	0.41	0.92	0.85	
+Black rot	0.27	0.16	0.15	0.08	0.31	0.18	0.39	0.24	0.76	0.61	
+Scab	0.19	0.11	0.10	0.05	0.10	0.05	0.23	0.13	0.54	0.37	
+Cedar rust	0.23	0.13	0.15	0.08	0.21	0.12	0.21	0.12	0.63	0.46	
+Bold values indicate the best results with the direction of optimality defined by the table header.
+
+The original version of this article has been updated.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Edited and reviewed by: Yu Nishizawa, Kagoshima University, Japan
+
diff --git a/corpus/healthcare/text/8fa358ec643ce6a1.txt b/corpus/healthcare/text/8fa358ec643ce6a1.txt
new file mode 100644
index 0000000000000000000000000000000000000000..22871166925764198c9451e9696a4160285733a4
--- /dev/null
+++ b/corpus/healthcare/text/8fa358ec643ce6a1.txt
@@ -0,0 +1,74 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Glob Womens Health
+Journal ID: Front Glob Womens Health
+NLM Journal ID: 101776281
+Journal ID: Front. Glob. Women’s Health
+
+Frontiers in Global Women's Health
+
+EISSN: 2673-5059
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13389960
+PMID: 42488914
+DOI: 10.3389/fgwh.2026.1913342
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: PDGF-BB as a potential biomarker for early diagnosis of postpartum hemorrhage
+
+Thirugnanam Karthikeyan 1 Writing – review & editing Methodology Validation Investigation Writing – original draft
+Polnaszek Brock E. 2
+Eng Kevin 3 Writing – review & editing
+Pan Amy Y. 4 Writing – review & editing Validation Formal analysis Data curation Software Methodology
+Ramchandran Ramani 1 3 * Supervision Investigation Writing – original draft Conceptualization Writing – review & editing Funding acquisition Formal analysis Project administration Visualization Data curation Resources
+1 Department of Pediatrics, Division of Neonatology, Developmental Vascular Biology Program, Medical College of Wisconsin, Children’s Research Institute (CRI) , Milwaukee , WI , United States
+2 Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Medical College of Wisconsin , Milwaukee , WI , United States
+3 CIAN, Inc. , Pewaukee , WI , United States
+4 Division of Bioinformatics and Quantitative Child Health, Department of Pediatrics, Medical College of Wisconsin, CRI , Milwaukee , WI , United States
+* Correspondence: Ramani Ramchandran rramchan@mcw.edu
+Electronic publication date: 2026 Jul 8
+Publication date: 2026
+Volume: 7
+Electronic Location ID: 1913342
+Received 2026 Jun 18; Revised 2026 Jun 22; Accepted 2026 Jun 25
+Copyright: © 2026 Thirugnanam, Polnaszek, Eng, Pan and Ramchandran.
+Copyright year: 2026
+Copyright holder: Thirugnanam, Polnaszek, Eng, Pan and Ramchandran
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: PDGF-BB as a potential biomarker for early diagnosis of postpartum hemorrhage 7 17 6 2026 1849806 Frontiers in Global Women's Health 10.3389/fgwh.2026.1849806 PMC13318863 42389024
+Keywords: biomarker, bleeding, cilia, endothelial, placenta
+
+Funding: National Institutes of Health 10.13039/100000002 HL154254 HL179583 R41NS139906
+Figure count: 1
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Maternal Health
+
+Ÿ==============================Ÿ
+Error in figure 1
+
+In the published article, titled, “PDGF-BB as a potential biomarker for early diagnosis of postpartum hemorrhage,” we noticed an error in the Figure 1, which is detailed below and needs correction.
+
+Wrong content
+
+There was a mistake in Figure 1 as published. The 1A panel has incorrect labels. In 1a, the panel in the published manuscript is labeled PC + PPH and PC. The correct labeling is PE + PPH and PE. The corrected Figure 1A appears below.
+
+Figure 1
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Edited by: Carlos Alonso Escudero, University of the Bío Bío, Chile
+
diff --git a/corpus/healthcare/text/94ef45a94f7e3473.txt b/corpus/healthcare/text/94ef45a94f7e3473.txt
new file mode 100644
index 0000000000000000000000000000000000000000..6e2850aae86e098f540d270e803499fa55b50efc
--- /dev/null
+++ b/corpus/healthcare/text/94ef45a94f7e3473.txt
@@ -0,0 +1,332 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Psychol Med
+Journal ID: Psychol Med
+NLM Journal ID: 1254142
+Journal ID: PSM
+
+Psychological Medicine
+
+ISSN: 0033-2917
+EISSN: 1469-8978
+Publisher: Cambridge University Press
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13079223
+PMID: 41958303
+DOI: 10.1017/S0033291726104139
+Article ID: S0033291726104139
+Article version: 1
+Subjects: Original Article
+
+Interventions to prevent antipsychotic-induced weight gain and metabolic complications in individuals with a first-episode psychosis and minimal antipsychotic exposure: a systematic review and meta-analysis
+
+https://orcid.org/0000-0002-1530-0167 O’Mahony Brian William 1
+Burke Tara 1
+https://orcid.org/0009-0000-5808-0208 Hamill Ruby 1
+https://orcid.org/0000-0003-2137-2631 Gannon Louisa 1
+Perry Benjamin I. 2
+https://orcid.org/0000-0002-2072-9216 Siskind Dan 3
+Pawełczyk Tomasz 4
+O’Shea Donal 1
+https://orcid.org/0000-0001-6240-6952 O’Donoghue Brian 1
+1 University College Dublin , Dublin , Ireland
+2 University of Birmingham , UK
+3 The University of Queensland , Australia
+4 Medical University of Lodz: Uniwersytet Medyczny w Lodzi , Poland
+Corresponding author: Brian William O’Mahony; Email: brian.omahony3@ucdconnect.ie
+Publication date: 2026
+Electronic publication date: 2026 Apr 10
+Volume: 56
+Electronic Location ID: e101
+Received 2025 Oct 17; Revised 2026 Feb 5; Accepted 2026 Mar 18
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+Copyright holder: The Author(s)
+License: This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: antipsychotic, BMI, first episode, metabolic, physical health, psychosis, schizophrenia, side effect, weight gain, prevention
+
+Funding: Health Research Board https://doi.org/10.13039/100010414 ICAT-2022-001
+Figure count: 2
+Table count: 2
+Reference count: 68
+Page count: 10
+tdm-reservation: 1
+tdm-policy: https://www.cambridge.org/tdm/tdmrep-policy.json
+
+Ÿ==============================Ÿ
+Background
+
+Rapid weight gain commonly occurs following the onset of first-episode psychosis (FEP), leading to cardiometabolic disease. Most weight gain in FEP occurs in the first 3 months of treatment, offering a critical window for prevention. Despite this, most studies aiming to prevent antipsychotic-induced weight gain include people with chronic illness or people who have had lengthy exposure to antipsychotic medication. We aimed to synthesize and analyze the literature on interventions aimed at preventing antipsychotic-induced weight gain.
+
+Methods
+
+We conducted a systematic review in PsycInfo, MEDLINE, CINAHL, and EMBASE of studies that examined the effectiveness of interventions in preventing antipsychotic-induced weight gain in FEP. We examined their effect on weight gain and a range of cardiometabolic markers.
+
+Results
+
+We screened 2,092 articles, 13 of which were eligible. Behavioral interventions, all three of which consisted of a multidisciplinary team approach, resulted in a mean of 3.05 kg less weight gain than treatment-as-usual (95% CI 1.36 kg to 4.73 kg). Pharmacological interventions displayed marked clinical and statistical heterogeneity, with each of the seven trials in adults using a different pharmacological intervention. Few studies collected comprehensive data on metabolic health. Only two pharmacological studies, and five studies in total, have been published since 2010.
+
+Conclusions
+
+Despite the importance of preventing weight gain in FEP, there have been few recent studies investigating this topic. Our results indicate that multidisciplinary team interventions are effective in preventing weight gain in FEP and should be offered to all patients.
+
+Introduction
+
+Higher mortality in people with severe mental illness is well recognized, with an estimated 15-year reduction in life expectancy, of which cardiometabolic conditions are a key component (Laursen, 2011; Plana-Ripoll et al., 2019). This mortality gap is widening, pointing to a failure of interventions to prevent or treat cardiovascular risk factors (Nielsen, Uggerby, Jensen, & McGrath, 2013). Globally, people with severe mental illness have increased rates of overweight and obesity (Afzal et al., 2021), which are major mediators of cardiovascular disease incidence and mortality (Correll et al., 2017; Peeters et al., 2003).
+
+Weight gain is common in people following the onset of psychotic illnesses, and is influenced by genetic predisposition, diet, lifestyle, and the use of antipsychotic medication (Correll, Lencz, & Malhotra, 2011; Dipasquale et al., 2013; Pillinger et al., 2017; Vancampfort et al., 2017). A key finding of the literature on antipsychotic-induced weight gain (AIWG) is that most of the total weight gain occurs in the first 3 months of exposure to the medication and is particularly pronounced in people who are drug-naïve (Alvarez-Jimenez et al., 2008; Pérez-Iglesias et al., 2014; Zipursky et al., 2005). Therefore, any intervention aimed at preventing AIWG should be delivered at the time of initiation of the first antipsychotic medication or with minimal prior exposure to such treatments. Systematic reviews to date on the prevention of AIWG, while informative, are limited by the inclusion of studies involving individuals who were not all experiencing a first episode or who had previous exposure to antipsychotic medications (Agarwal, Stogios, Faulkner, & Hahn, 2023; Nyboe, Lemcke, Møller, & Stubbs, 2019; Yu et al., 2024).
+
+The weight gain and adverse metabolic effects caused by antipsychotics are a result of their widespread binding to monoaminergic receptors in both the central nervous system and peripheral tissues. For example, blockade of histamine-1 (H1) and Serotonin 2c (5HT2c) receptors has been linked to increases in appetite, while second-generation antipsychotics’ effect on receptors in the pancreas, liver, and skeletal muscle leads to dysregulation of glucose and lipid homeostasis (Carli et al., 2021). Antipsychotics’ propensity to increase appetite compounds the unhealthy diet often seen in people with psychotic disorders (Dipasquale et al., 2013), and their sedative effects are likely contributors to the sedentary behavior of people with psychotic disorders (Stubbs, Williams, Gaughran, & Craig, 2016).
+
+Early intervention in psychosis services was founded with the recognition that this critical period offers an opportunity to minimize the adverse effects of psychosis on an individual experiencing first-episode psychosis (FEP). The same principle of early intervention should be applied to physical health, given that metabolic changes are far more difficult to reverse than to prevent (Lemieux & Després, 2020).
+
+Given this, we aimed to comprehensively review the literature on, and analyze the effectiveness of, interventions in preventing weight gain in individuals experiencing a first episode of psychosis who are antipsychotic-naïve or have had minimal exposure. We also aimed to assess the effectiveness of interventions to prevent other metabolic complications, specifically the components of metabolic syndrome, including hypertension, hyperglycemia, and dyslipidemia.
+
+Methods
+
+Types of studies
+
+We included randomized controlled trials (RCTs), non-randomized controlled trials, and other interventional study designs such as pre–post studies. We excluded non-interventional observational studies, cohort studies, case studies, and case series.
+
+Types of participants
+
+We included studies whose participants were experiencing a FEP, and who had been exposed to antipsychotics for less than 4 weeks. If a study allowed a longer exposure to antipsychotic medications as part of their inclusion criteria, we contacted the authors and asked if they could provide data pertaining to participants with less than 4 weeks of exposure. We set no restrictions on participant demographic characteristics or duration of untreated psychosis.
+
+Search strategy
+
+We searched the following databases: PsycInfo, MEDLINE, CINAHL, and EMBASE. We constructed the search using three core concepts: (1) the population (schizophrenia and psychosis), (2) the outcomes of interest (metabolic health factors), and (3) a specifier for the illness stage (early or first episode). For each concept, a combination of controlled vocabulary terms (e.g. MeSH, Emtree, CINAHL Subject Headings) and free-text keywords was used. Where appropriate, we ‘exploded’ controlled vocabulary terms to capture all related sub-headings. Supplementary Appendix A details the full search strategy. We inspected references of all included studies for further relevant studies. The latest original search date was 20th December 2024. We then carried out another full search on 16th October 2025, prior to submission, at which point we identified no new relevant studies.
+
+Study selection
+
+Two independent reviewers screened citations and full texts and resolved disagreements by consensus or by discussing with a third reviewer. When adequate information was not available, we attempted to contact the authors of the study concerned for clarification.
+
+Data extraction
+
+Data were first extracted on 14th January 2025. We chose mean weight gain in kilograms (kg) as our outcome measure for the primary objective, prevention of weight gain, and used mean difference in the meta-analysis. We also collected data on ‘clinically significant’ weight gain (≥7% weight increase from baseline); body mass index (BMI), waist circumference, and markers of metabolic health, for example, lipids, fasting glucose, and HbA1C. Where a study utilized a different unit of measurement, we converted to standardized metric units, for example, kilograms and mmol/l.
+
+When not provided in a paper, we estimated the mean difference between groups. When within-group standard deviations of mean differences were not provided, we estimated this standard deviation using confidence intervals, p-values, and/or results of Student’s t-test. Where necessary, we imputed the standard deviation of the mean difference by using the correlation coefficient from similar studies within the review (Chi, Li, Chen, & Kang, 2023). We weighed studies in the meta-analysis using inverse variance and conducted the meta-analysis using the RevMan web version (Review Manager, 2024).
+
+We used the Cochrane Handbook for Systematic Reviews of Interventions to assess the risk of bias in study quality (Cumpston et al., 2019). Where possible, we presented data on last observation carried forward (LOCF), and presented completer (per-protocol) analyses only when intention-to-treat data were not available.
+
+We examined clinical heterogeneity by comparing study populations and intervention types. We examined methodological heterogeneity by reviewing study design features. If we detected substantial clinical or methodological variability, we synthesized results narratively. We used the I2 statistic to investigate heterogeneity between studies (Higgins, Thompson, Deeks, & Altman, 2003). We considered an I2 statistic estimate of >75% to be indicative of substantial heterogeneity (Deeks, Higgins, Altman, & Group, 2019). For our meta-analysis, we used a fixed-effects model. We conducted sensitivity analyses where relevant, which included investigating different follow-up intervals and comparing analyses using a random-effects model.
+
+Results
+
+Search results are shown in Figure 1. Our search identified 2,207 articles. After removing 67 duplicates, 2,140 unique articles remained for abstract screening. We then reviewed the full texts of 90 studies. Of these, 10 studies strictly met our inclusion criteria (Arman, Sadramely, Nadi, & Koleini, 2008; Curtis et al., 2016; Kang et al., 2024; Narula, Rehan, Unni, & Gupta, 2010; O’Donoghue et al., 2022; Poyurovsky et al., 2002, 2004, 2007, 2013; Wu et al., 2008).Figure 1. PRISMA flowchart of study identification.
+
+Alvarez-Jimenez et al. had an inclusion threshold of less than 6 weeks of antipsychotic exposure, but indicated in their paper that no patients had more than 4 weeks of exposure to antipsychotic medication (Alvarez-Jimenez et al., 2006). This paper and its follow-up paper thus met our inclusion criteria (Álvarez-Jiménez et al., 2010). We identified 23 papers whose inclusion criteria indicated that they may have collected data on patients who met our own criteria. We contacted each corresponding and lead author of these papers and received data from Pawełczyk, Grancow-Grabka, Żurner, and Pawełczyk (2021). We were thus able to add these two studies (one of which was split into two papers) to our original 10 studies, allowing us to include 13 papers from 12 studies in our review.
+
+Study characteristics
+
+Table 1 presents the general characteristics of each study. We included 11 randomized control trials (Alvarez-Jimenez et al., 2006; Arman et al., 2008; Kang et al., 2024; Narula et al., 2010; O’Donoghue et al., 2022; Pawełczyk et al., 2021; Poyurovsky et al., 2002, 2004, 2007, 2013; Wu et al., 2008). The earliest study was published in 2002, and the most recent in 2024. Studies varied in sample size (14–77) and location. Eight studies focused on pharmacological methods to prevent AIWG, three studies focused on behavioral methods, and one study used continuous theta-burst stimulation (cTBS). Only two of the studies of pharmacological interventions were published after 2010.Table 1. General characteristics of identified studies
+
+Author Year Country	Population	% Male	Mean Age(SD)	Follow-up length	No. of patients (analyzed)	Intervention	Control	
+Alvarez-Jimenez et al. (2006, 2010),
+Spain	Outpatients, FEP, <6 weeks APS exposure a	75.4%	28.8 (12.1)	2 years (1 year in meta-analysis	61 (61)	Early Behavioral Intervention, 10–14 individual sessions with a clinical psychologist,
+Goals: Engagement & assessment, education, dietary counselling, exercise program, behavior therapy	Weekly sessions: General advice on weight management without structured intervention.	
+Arman et al. (2008),
+Saudia Arabia	Inpatients, <20 years old, FEP, drug naïve, prescribed risperidone	65.6%	10.1 (3.6)	12 weeks	49 (32) Per protocol	Risperidone 2–6 mg OD, Metformin 500 mg BD,
+For 12 weeks	Risperidone 2–6 mg OD
+For 12 weeks	
+Curtis et al. (2016),
+Australia	Outpatients, FEP, <4 weeks of APS exposure
+Medically fit enough to exercise	60.7%	20.7 (2.2)	12 weeks	49 (28)
+Per protocol	Health coaching by nurse specialist, dietician support, exercise program tailored by exercise physiologist, peer wellness coaches. enhanced pharmacovigilance	Individual case management with medical assessment and antipsychotic prescription based on clinical guidelines	
+Kang et al. (2024),
+China	Inpatients, FEP, drug-naïve, no other mental disorders, comorbid severe physiological diseases, or pregnant/lactating women;	13.9%	25.8 (7.4)	5 days	39 (36) ITT	25 sessions (5 days) continuous theta-burst stimulation 50 Hz bursts of three pulses every 200 ms. Intensity of 80% of the individual resting motor threshold	25 sessions over 5 days, with the coil tilted 90° to the scalp to avoid stimulation of the motor cortex	
+Narula et al. (2010),
+India	FEP, drug naïve, no other neuropsychiatric illness, not taking SSRI, or mood stabilizer	65.7%	31.1 (9.8)	12 weeks	72 (67) Per protocol	Olanzapine 5–20 mg OD, Topiramate 50–100 mg OD
+For 12 weeks	Olanzapine 5–20 mg OD
+For 12 weeks	
+O’Donoghue et al. (2022),
+Australia	Outpatients, 16–25 years old, FEP, < 30 days of APS exposure	50.6%	19.4 (3.4)	12 weeks	77 (61)
+	Education from a physical health nurse about diet, physical activity, & metabolic side-effects of medication.
+Referred to an exercise physiologist and dietician	As with the intervention group, but the referrals were handled directly by the case manager or psychiatrist	
+Pawełczyk et al. (2021),
+Poland
+	Inpatients, FEP, no intellectual disability or previous head injury	58.1%	23.7 (4.9)	26 weeks	71 (43 had <4 weeks of APS exposure) ITT	2.2 g of polyunsaturated fatty acids: (1.32 g/day of eicosapentaenoic acid & 0.88 g/day of docosapentaenoic acid	Prescribed antipsychotic and placebo containing olive oil	
+Poyurovsky et al. (2002),
+Israel	Inpatients, FEP, <4 weeks of APS exposure, no medical illness affecting body weight	78.3%	25.3 (6.5)	8 weeks	30 (24) Per protocol	Fluoxetine 20 mg OD & Olanzapine 10 mg nocte	Olanzapine 10 mg nocte & placebo	
+Poyurovsky et al. (2004),
+Israel	FEP inpatient prescribed olanzapine. <4 weeks of APS exposure, no mood or substance use disorder, no medical illness affecting body weight	57.1%	23.6 (1.7)	6 weeks	14 (14)
+	Famotidine 40 mg OD & olanzapine 10 mg nocte	Olanzapine 10 mg nocte & placebo	
+Poyurovsky et al. (2007),
+Israel
+	FEP inpatients prescribed olanzapine. <4 weeks of APS exposure, BMI of <30, no mood disorder or suicidal behavior, no medical illness affecting body weight	64.4%	29.9 (7.9)	6 weeks	59 (41)
+Per protocol with ITT sensitivity analysis	Reboxetine 4 mg BD & Olanzapine 10 mg per day	Olanzapine 10 mg per day & placebo	
+Poyurovsky et al. (2013),
+Israel	FEP inpatient prescribed olanzapine. <4 weeks of APS exposure, BMI <30, no mood disorder or suicidal behavior, no medical illness affecting body weight	81.4%	32.5 (9.2)	6 weeks	54 (43)
+ITT	Reboxetine 4 mg BD & Betahistine 48 mg TID & Olanzapine 10 mg per day	Olanzapine 10 mg nocte & placebo	
+Wu et al. (2008),
+China	Inpatients, FEP, no previous APS exposure, no illicit drugs in last 3 months, no diabetes, dyslipidemia, or cardiovascular disease	54.1%	25.1 (3.7)	12 weeks	40 (37)
+ITT	Metformin 250 mg TID & Olanzapine 15 mg nocte
+Standardized diet: 7980–9250 kilojoule/day	Olanzapine 15 mg nocte & placebo TID Standardized diet: 7980–9250 kilojoule/day	
+Note: FEP, first-episode psychosis, APS, antipsychotic, ITT, intention-to-treat.
+
+a The paper specified that, although their inclusion criteria was <6 weeks of APS exposure, no participant had more than 4 weeks of APS exposure.
+
+One study was conducted in children (n = 32) (Arman et al., 2008), with a mean age of 10.1 years. All other studies were conducted in adults aged between 18 and 65 years. Each of the eight pharmacological intervention studies (total n = 316) and the cTBS study (n = 39) was assessed in an inpatient setting, and participants in each of the three behavioral intervention studies (n = 187) were assessed in an outpatient setting.
+
+Pharmacological interventions were clinically heterogeneous. Among adult participants, no two studies assessed the same intervention. While the behavioral interventions were broadly characterized by a multidisciplinary approach, they differed in their theoretical frameworks and delivery personnel. Álvarez-Jiménez et al. (2006) utilized an Early Behavioral Intervention based on cognitive-behavioral principles. The intervention was delivered by clinical psychologists over 8–14 sessions, with the aim of modifying cognitive triggers and enhancing self-control over energy intake. In contrast, Curtis et al. (2016) implemented the Keeping the Body in Mind (KBIM) program, which was a high-intensity, holistic life-skills intervention delivered by a team of nurses, dietitians, and exercise physiologists. A unique feature of KBIM was the inclusion of youth peer wellness coaches who acted as role models during supervised gym sessions and practical life-skill activities, such as shopping tours and cooking classes. Finally, O’Donoghue et al. (2022) evaluated the Physical Health Assistance in Early Psychosis (PHAstER) study, which integrated a dedicated physical health nurse into existing teams to act as a central care coordinator. This model focused on motivational interviewing and facilitated referrals to existing allied health services.
+
+The type of antipsychotic used differed among studies. Among pharmacological interventions, six included only patients who were prescribed olanzapine (Narula et al., 2010; Poyurovsky et al., 2002, 2004 2007, 2013; Wu et al., 2008), as did Kang et al’s study of cTBS (Kang et al., 2024). Arman et al.’s (2008) study of metformin in adolescents included only patients who were prescribed risperidone. Each of the three behavioral interventions included patients who were prescribed a variety of antipsychotics (Alvarez-Jimenez et al., 2006; Curtis et al., 2016; O’Donoghue et al., 2022), as did Pawełczyck et al.’s (2021) study of polyunsaturated fatty acids.
+
+Control groups
+
+Table 1 describes the control intervention for each study. Among studies including only participants who were prescribed olanzapine, similar weight gain was noted among those with a 6-week follow-up (4.77–5 kg) Poyurovsky et al., 2002, 2004, 2007, 2013), and among those with a 12-week follow-up (6.03 kg and 6.87 kg) (Narula et al., 2010; Wu et al., 2008). The control group in Kang et al’s study gained 1.1 kg in just 5 days (Kang et al., 2024). Mean weight gain was lower in studies that used a variety of antipsychotics. The control group of inpatients in Pawełczyk et al.’s (2021) study gained 2 kg at 13 weeks and 4 kg at 26 weeks. All participants in the three behavioral studies were outpatients with FEP with less than 4 weeks of antipsychotic exposure. Despite these similarities, there was a significant difference in weight gain between the three control groups at 3-month follow-up (F = 6.615, p < 0.01). The control group in O’Donoghue et al.’s (2022) study gained less weight (2.9 kg) than the control group in Curtis et al.’s (2016) study (7.8 kg) or Alvarez-Jimenez et al’s (2006) study (7 kg).
+
+Risk of bias and study quality
+
+Table 2 shows our assessment of each study’s risk of bias across domains. Arman et al.’s (2008) paper included only patients with a diagnosis of first-episode schizophrenia, but with a mean age of 10.1 (SD 3.6). We did not identify any conflicts of interest that may have impacted study quality.Table 2. Risk of bias
+
+Author	Random sequence generation	Allocation concealment	Blinding of personnel and participants	Blinding of outcome assessment (weight)	Blinding of outcome assessment (others)	Incomplete outcome data	Selective reporting	Other bias	
+Alvarez-Jimenez et al. (2006, 2010)									
+Arman et al. (2008)									
+Curtis et al. (2016)									
+Kang et al. (2024)									
+Narula et al. (2010)									
+O’Donoghue et al. (2022)									
+Pawełczyk et al. (2021)									
+Poyurovsky et al. (2002)									
+Poyurovsky et al. (2004)									
+Poyurovsky et al. (2007)									
+Poyurovsky et al. (2013)									
+Wu et al. (2008)									
+Note:  = Low risk of bias  = Unclear risk of bias  = High risk of bias.
+
+Prevention of weight gain
+
+Figure 2 presents forest plots of the last observed weight gain for each intervention in adults, excluding Kang et al.’s (2024) study due to the short follow-up of 5 days. Figure 2 also presents the results of our meta-analysis on the effects of behavioral interventions aimed at preventing AIWG.Figure 2. Forest plots of mean difference in weight gain at last of observation for interventions in adults.
+
+When examined together using a fixed-effects model, non-pharmacological interventions for preventing AIWG resulted in a mean of 3.05 kg less weight gain than treatment-as-usual (95% CI, 1.36–4.73 kg). This result was robust to a sensitivity analysis of using a random-effects model (mean difference 3.06 kg, 95% CI, 0.11–6.01 kg), and to adjustment of the follow-up period to 3 months (the end of each intervention). A sensitivity analysis excluding Curtis et al.’s (2016) paper, due to its non-randomized design and high risk of bias, resulted in a non-significant impact of behavioral interventions on preventing AIWG, with a mean of 1.66 kg less weight gain than treatment-as-usual (95% CI −0.38 kg to 3.71 kg, p = 0.112). We judged the studies to be clinically homogeneous, with all three making use of a multidisciplinary team approach to preventing AIWG, and the I2 statistic was 71% (95% CI, 0%–99.27%, df = 2).
+
+We considered the pharmacological interventions to be unsuitable for a meta-analysis, both due to clinical and statistical heterogeneity (I2 = 82%, 95% CI 56.7–96.3%, df = 6). Four studies showed evidence for an effect in reduction in weight gain: Metformin (mean difference of 3.2 kg, 95% CI 1.09–5.31 kg),[31] topiramate (mean difference of 7.2 kg, 95% CI 5.28–9.32 kg),[32] reboxetine (mean difference 1.6 kg, 95% CI 0.3–2.9 kg),[29] and a reboxetine/betahistine combination (mean difference 2.8 kg, 95% CI 0.86–4.74 kg) [30].
+
+Kang et al.’s (2024) feasibility study of cTBS had a follow-up of only 5 days, however, they reported 1.14 kg (95% CI 0.3–1.98 kg) less weight gain in the intervention group, with a 5-day weight increase of 1.13 kg in the sham group.
+
+Metabolic markers
+
+Most studies did not collect serum markers of metabolic health. Four studies presented data on serum lipids or triglycerides (Curtis et al., 2016; Kang et al., 2024; Narula et al., 2010; Pawełczyk et al., 2021), of which only the intervention with topiramate showed a favorable difference. The mean change in low-density lipoprotein (LDL) was significantly lower in the intervention group compared to placebo (mean difference 0.21 mM/L, 95% CI 0.07 mM/L to 0.35 mM/L) (Narula et al., 2010). Five studies presented data markers of changes in fasting glucose (Curtis et al., 2016; Kang et al., 2024; Narula et al., 2010; Pawełczyk et al., 2021; Wu et al., 2008). Of these, only the intervention of topiramate showed a significant reduction compared to control (mean difference 0.56 mM/L, 95% CI 0.41 mM/L to 0.72 mM/L) (Narula et al., 2010). Metformin showed a favorable response in fasting insulin and in the insulin-resistance index (Wu et al., 2008).
+
+Discussion
+
+This is the first systematic review of interventions aiming to prevent antipsychotic-induced weight gain (AIWG), by intervening in drug-naïve or minimally exposed people. Our meta-analysis concords with reviews that advocate for a multidisciplinary team approach, with an emphasis on physical health, being a first-line treatment for people with FEP (Firth et al., 2019). Both fixed-effect and random-effect models showed that behavioral interventions were effective. Although excluding a study with a high risk of bias resulted in the meta-analysis showing no effect, this was largely driven by lower weight gain in the O’Donoghue et al. (2022) control group, who themselves received a multidisciplinary team intervention. Although such interventions would be biologically most effective if implemented immediately upon commencement of antipsychotic medication, patients must have recovered to an extent that they may engage in behavioral interventions, which may be difficult until after a period of antipsychotic exposure. Thus, in practice, these interventions should be commenced as soon as is practically possible. If a multidisciplinary team approach is not possible, pharmacological interventions show promise, but with low certainty of evidence. Pharmacological interventions as first-line may be reserved for high-risk individuals, who may be identified by a validated risk calculator (Carolan et al., 2025; Perry et al., 2021).
+
+The statistical heterogeneity of behavioral interventions was below the 75% cut-off set out in our protocol, but the interventions differed clinically. Notably, the weight gain in the treatment-as-usual group was far lower in the O’Donoghue et al study compared to the others. O’Donoghue et al.’s (2022) control group received a full complement of multidisciplinary team input, similar to Curtis et al.’s (2016) KBIM intervention. Meanwhile, the control groups in Alvarez-Jimenez et al.’s (2006) and Curtis et al.’s (2016) studies received only standard medical reviews. This would appear to indicate that the service-wide MDT approach was itself effective in preventing weight gain. Although not specifically reported as confounders in these studies, both positive and negative symptoms may interfere with a patient’s ability to partake in behavioral interventions (Giordano et al., 2022; O’Keeffe, Conway, & McGuire, 2017).
+
+Notably, only two studies of pharmacological interventions have been carried out since 2010, with one of these being a secondary analysis of a prior study (Pawełczyk et al., 2016). The limited number of identified studies is most likely due to the difficulty in recruiting a drug-naïve FEP cohort for interventional studies. Patients must have suffered a recent episode of severe mental illness but have stabilized sufficiently within the 4-week window to provide informed consent for study participation. In routine clinical practice, the number of individuals eligible for such intervention substantially surpasses those who can be feasibly enrolled in RCTs.
+
+Only four studies assessing the impact of interventions on lipid profile or glucose regulation were identified, with most reporting these as secondary outcomes with limited statistical power. Fasting glucose, which is not consistently altered in early insulin resistance, was the primary measure of glucose homeostasis in nearly all intervention studies, and its relevance to glucose dysregulation in FEP patients remains unclear (Perry et al., 2016; Pillinger, D’ambrosio, McCutcheon, & Howes, 2019). Notably, only one study assessed for insulin resistance (Wu et al., 2008), a factor which has consistently been shown to be elevated at FEP (Perry et al., 2016; Pillinger et al., 2019).
+
+Pharmacological interventions were notable for both statistical heterogeneity and heterogeneity in the medications used, with the latter likely explaining the former. Other possible explanations for this statistical heterogeneity include variations in study duration and participant ethnicity (Pillinger et al., 2020). The pharmacological interventions identified made use of a variety of mechanisms to prevent AIWG. Metformin likely ameliorates weight gain by improving insulin sensitivity, reducing hepatic glucose production, and lowering appetite (LaMoia & Shulman, 2021). Topiramate is thought to reduce weight gain primarily through its effect on appetite and by increasing energy expenditure (Verrotti et al., 2011). The different monoamine modulators used by Poyurovsky et al. are less commonly recognized as methods to prevent AIWG, but the apparent effectiveness of reboxetine is intriguing, given the high rates of antidepressant prescriptions in FEP services (Hamina et al., 2023; Robinson et al., 2015).
+
+While our review has not added clear evidence regarding the FEP population specifically, pharmacological treatment has been shown to be effective in treating metabolic dysfunction in patients with psychotic disorders (Ye et al., 2023). Metformin has shown particular promise (Mansuri et al., 2022; Peng et al., 2025), and its use has been recommended as part of routine care (Carolan et al., 2025). Indeed, a meta-analysis of studies that commenced metformin within 1 year of antipsychotic initiation showed its efficacy (Yu et al., 2024). However, pharmacological interventions carry short and long-term side-effects, which range from mild to severe. The most bothersome side effect of metformin is gastrointestinal upset, but its use can also lead to pancreatitis, lactic acidosis, and hepatotoxicity (Shurrab & Arafa, 2020). Similarly, topiramate has shown a positive impact on both symptomatology and weight in schizophrenia, but has led to notable cognitive side effects. These cognitive effects have contributed to a decline in topiramate use as a first-line treatment for epilepsy (Mula & Trimble, 2009; Okuyama et al., 2016). There has been limited research into the long-term outcomes of such pharmacological interventions, meaning that their prescription and these side-effects may last indefinitely.
+
+Behavioral interventions have similarly shown promise in improving metabolic health in individuals with psychotic disorders (Naslund et al., 2017). They offer several advantages that are not typically associated with pharmacological approaches, such as fostering skills that would extend beyond the time-period of a medication prescription. Behavioral interventions are also more likely to empower patients and engender a sense of autonomy, self-actualization, and self-esteem, which are crucial in overcoming the stigma associated with psychotic disorders (Firth et al., 2019).
+
+Negative symptoms, periods of mental illness, chronic stress, and side effects of antipsychotic medication may all contribute to difficulties in initiating and adhering to behavioral treatments (Firth et al., 2018). However, amotivation and apathy do not preclude an individual with serious mental illness from engaging in and benefiting from exercise (Carpiniello et al., 2013; Firth et al., 2016). Indeed, exercise appears to be effective in alleviating these same negative symptoms (Kim, Lee, & Kang, 2023). Long-term adherence to such interventions has been demonstrated to wane as the structure and support of the intervention are withdrawn. However, this effect may be greater in patients with chronic schizophrenia rather than FEP, which offers a critical window to implement interventions (Carpiniello et al., 2013; Deighton & Addington, 2014). An interesting study not included in our review, as we did not consider it a true intervention, showed reduced weight gain in patients taking orally disintegrating olanzapine rather than a standard olanzapine tablet (Arranz et al., 2007). Various mechanisms have been proposed, including differences in absorption, activation of serotonergic receptors in the pylorus, and effects on taste receptors and gastrointestinal hormones (Karagianis et al., 2008). Of note, this difference in weight gain was not replicated in a larger trial of olanzapine-naïve, though not antipsychotic-naïve, individuals with schizophrenia (Kusumi et al., 2012). The impact of this strategy on drug-naïve individuals experiencing a FEP may be worth exploring.
+
+Although not included in our review, Glucagon-Like Peptide 1 (GLP-1) agonists will likely play a large role in the future of AIWG treatment (Ganeshalingam et al., 2024), given their remarkable results in inducing weight loss in obese and diabetic patients (Bak et al., 2024). The pilot study of continuous theta burst stimulation by Kang et al. showed tolerability and a significant reduction in weight gain, but was limited by a very short follow-up period of 5 days (Kang et al., 2024). Their hypothesis, that this effect was mediated by improved cognitive restraint on food, is intriguing and offers a promising avenue for future research.
+
+Conclusion
+
+Despite the importance of preventing weight gain in FEP, there have been few studies investigating this topic. Additionally, many are limited by small sample sizes and short study durations. Despite these limitations, several interventions appear promising in addressing a clinically significant contributor to excess morbidity and mortality in this population. Our results indicate that multidisciplinary team interventions appear to be effective in preventing weight gain in FEP and, given their lack of adverse effects, should ideally be offered to all patients. Future research should investigate true prevention of harm to metabolic health by antipsychotics, through recruitment of drug-naïve or minimally exposed patients, and by performing comprehensive assessments of metabolic health.
+
+Supporting information
+
+10.1017/S0033291726104139.sm001 O’Mahony et al. supplementary material 1
+
+O’mahony et al. supplementary material
+
+10.1017/S0033291726104139.sm002 O’Mahony et al. supplementary material 2
+
+O’mahony et al. supplementary material
+
+Supplementary material
+
+The supplementary material for this article can be found at http://doi.org/10.1017/S0033291726104139.
+
+Funding statement
+
+This research was funded by the Health Research Board (ICAT-2022-001) and the ICAT Programme, which is supported by the Health Service Executive, National Doctors Training and Planning, the Health and Social Care, Research and Development Division, the Northern Ireland Medical and Dental Training Agency, the Department of Agriculture, Food and the Marine, and the College of Anaesthesiologists of Ireland.
+
+Competing interests
+
+The authors declare no competing interests.
+
+
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+PMCID: PMC12468861
+PMID: 41004556
+DOI: 10.1371/journal.pone.0333593
+Article ID: PONE-D-24-08743
+Article version: 1
+Subjects: Research Article, Medicine and Health Sciences, Medical Conditions, Parasitic Diseases, Malaria, Medicine and Health Sciences, Medical Conditions, Tropical Diseases, Malaria, Medicine and Health Sciences, Pharmaceutics, Drug Therapy, People and Places, Population Groupings, Age Groups, Children, People and Places, Population Groupings, Families, Children, People and Places, Geographical Locations, Africa, Medicine and Health Sciences, Pharmacology, Adverse Reactions, Medicine and Health Sciences, Health Care, Socioeconomic Aspects of Health, Medicine and Health Sciences, Public and Occupational Health, Socioeconomic Aspects of Health, Research and Analysis Methods, Mathematical and Statistical Techniques, Statistical Methods, Metaanalysis, Physical Sciences, Mathematics, Statistics, Statistical Methods, Metaanalysis, Medicine and Health Sciences, Epidemiology, Medical Risk Factors
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+Prevalence and associated factors of delay in seeking malaria treatment among under five children in the Horn of Africa: A systematic review and meta-analysis
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+Associated factors, children, Horn of Africa, malaria, prevalence, treatment delay
+
+https://orcid.org/0000-0003-0808-124X Agimas Muluken Chanie Conceptualization Data curation Formal analysis Investigation Methodology Software Supervision Validation Visualization Writing – original draft Writing – review & editing 1 *
+https://orcid.org/0000-0002-7152-6435 Aweke Mekuriaw Nibret Conceptualization Formal analysis Methodology Validation Writing – original draft Writing – review & editing 2
+Mengistu Berhanu Conceptualization Formal analysis Investigation Methodology 2
+Baffa Lemlem Daniel Methodology Software Validation Writing – original draft Writing – review & editing 2
+Fentie Elsa Awoke Conceptualization Formal analysis Software Writing – original draft Writing – review & editing 3
+Shewarega Ever Siyoum Data curation Formal analysis Methodology Writing – original draft 3
+Belew Aysheshim Kassahun Conceptualization Funding acquisition Methodology Visualization Writing – original draft Writing – review & editing 2
+Muhammad Esmael Ali Conceptualization Formal analysis Methodology Software Supervision Writing – original draft Writing – review & editing 2
+1 Department of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
+2 Department of Human Nutrition, Institute of Public Health, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
+3 Department of Reproductive Health, Institute of Public Health, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia
+Birru Eshetie Melese Editor
+The kids Research Institute Australia, AUSTRALIA
+Competing Interests: The authors have declared that no competing interests exist.
+
+* E-mail: mulukensrc12@gmail.com
+Electronic publication date: 2025 Sep 26
+Publication date: 2025
+Volume: 20
+Issue: 9
+Electronic Location ID: e0333593
+Received 2024 Mar 4; Accepted 2025 Sep 16
+Copyright: © 2025 Agimas et al
+Copyright year: 2025
+Copyright holder: Agimas et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Prevalence and associated factors of delay in seeking malaria treatment among under five children in the Horn of Africa: A systematic review and meta-analysis. 20 9 26 9 2025 e0333593 e0333593 PLoS One 10.1371/journal.pone.0333593 41004556
+Prevalence and associated factors of delay in seeking malaria treatment among under five children in the Horn of Africa: A systematic review and meta-analysis. 20 9 26 9 2025 e0333593 e0333593 PLoS One 10.1371/journal.pone.0333593 41004556
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 12
+Table count: 2
+Page count: 21
+Data Availability: All relevant data are within the manuscript.
+
+Data Availability
+
+All relevant data are within the manuscript.
+
+Ÿ==============================Ÿ
+Introduction
+
+Malaria is a global public health problem, particularly in sub-Saharan African countries. It is responsible for 90% of all deaths worldwide. To reduce the impact and complications associated with delayed treatment of malaria among children under five, comprehensive evidence about the magnitude and determinants of delayed treatment for malaria could be the solution. But there are no national-level studies in the Horn of Africa for decision-makers.
+
+Objective
+
+To assess the prevalence and associated factors of delay in seeking malaria treatment among under-five children in the Horn of Africa.
+
+Method
+
+Published and unpublished papers were searched on Google, Google Scholar, PubMed/Medline, EMBASE, SCOPUS, and the published articles’ reference list. The search mechanism was established using Medical Subject Heading (MeSH) terms by combining the key terms of the title. Joana Brigg’s Institute critical appraisal checklist was used to assess the quality of articles. A sensitivity test was conducted to evaluate the heterogeneity of the studies. The visual funnel plot test and Egger’s and Begg’s statistics in the random effect model were done to evaluate the publication bias and small study effect. The I2 statistics were also used to quantify the amount of heterogeneity between the included studies.
+
+Results
+
+The pooled prevalence of delayed treatment for malaria among under-five children in the Horn of Africa was 48% (95% CI: 34%–63%). History of child death (OR =2.5, 95% CI: 1.73–3.59), distance >3000 meters (OR = 2.59, 95% CI: 2.03–3.3), drug side effect (OR = 2.94, 95% CI: 1.86–4.67), formal education (OR = 0.69, 95% CI: 0.49–0.96), middle income (OR = 0.42, 95% CI: 0.28–0.63), expensiveness (OR = 4.39, 95% CI: 2.49–7.76), and affordable cost (OR = 2.13, 95% CI: 1.41–3.2) for transport were factors associated with malaria treatment delay among children.
+
+Conclusion and recommendations
+
+About one out of two parents in the Horn of Africa put off getting their kids treated for malaria. High transportation expenses, long travel times (greater than 3,000 meters) to medical facilities, and anxiety about drug side effects were major risk factors that contributed to this delay. On the other hand, a middle-class income was found to be protective of treatment delays. These results highlight how crucial it is to improve access to healthcare services, both financially and physically, to minimize delays in treating malaria in the area’s children.
+
+1. Introduction
+
+Malaria is a communicable parasitic disease caused by female Anopheles mosquito [1,2]. The PLASMODIUM FALCIPARUM parasite is the most commonly responsible cause for malaria infection (3). Globally, children are the most vulnerable population and about 67% of all malarial related death are under five children [3]. Malaria is a global public health problem, particularly in sub-Saharan African countries, where it accounts for 90% of global mortality and morbidity [4]. Most malaria-related deaths can be reversed by prompt diagnosis and treatment. Even though there is a significant improvement towards the elimination of malaria in Africa, it is still the major public health concern in the tropical regions and in the poor health care systems of countries like the Horn of Africa [5].
+
+The World Health Organization recommended that confirmed children with malaria must be treated within 24 hours but in sub-Saharan African countries, the proportion of early treatment among children is very low [6]. According to 2019 World Health Organization malaria report, between 2015 and 2018, about 36% of sub-Saharan African children under five did not receive malaria treatment [7]. Although early treatment-seeking behavior is the most important strategy, long distance, lack of transport, and low income are the most common reasons for not receiving prompt treatment and diagnosis among children [8]. The other possible reason for delayed treatment for malaria among children is affordability, acceptability, and adequacy to meet expectations in quality of care [9,10]. Unless children get malaria treatment early, it could be complicated into severe forms of malaria, disability, and death [11]. In the Horn of Africa, a significant proportion of children with malaria did not get any medical treatment. [12]. To reduce the impact and complications associated with delayed treatment of malaria among children under five, comprehensive evidence about the magnitude and determinants of delayed treatment for malaria could be the solution. But there are no sub-regional-level studies in the Horn of Africa for decision-makers. Therefore, the current study aimed to assess the prevalence and associated factors for delayed treatment of malaria among children in the Horn of Africa using a systematic review and meta-analysis.
+
+2. Methodology
+
+2.1 Design
+
+We have used and follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P 2015 Guidelines) to conduct this review [13].
+
+2.2 Searching strategy
+
+Both published and unpublished articles were searched on search engines like Google, Google Scholar, PubMed/Medline, EMBASE, SCOPUS databases, and the published article’s reference list from January 17, 2024, to February 17, 2024. The medical subject heading (MeSH) terms with the key term of the title were used for searching. Missed articles from the search engines were checked for each retrieved article reference. The eight authors (Muluken Chanie Agimas, Aysheshim Kassahun Belew, Elsa Awoke Fentie, Lemlem Daniel Baffa, Esmael Ali Muhammad, Berhanu Mengistu, Ever Siyoum Shewarega, Mekuriaw Nibret Aweke) were involved in the independent searching of articles. To search for eligible articles from search engines, we used the following entry terms:
+
+(((((“Delay health care seeking”[All Fields] OR “treatment seeking”[All Fields] OR ‘risk factors” [All Fields]) OR determinants”[All Fields] AND malaria[All Fields] AND “under five children” [All Fields] OR Ethiopia[All Fields] OR Djibouti [All Fields] OR Eritrea[All Fields] OR Somali [All Fields] OR Uganda[All Fields] OR Sudan[All Fields] OR South Sudan[All Fields] OR Kenya[All Fields].
+
+All searched articles from different search engines and methods were imported to EndNote X8 software for further article screening. To facilitate the screening process in the EndNote X8 software, we attach the PDF file to the EndNote X8 software. Before screening each article one by one using titles and abstracts, the first duplicate articles were removed. Paired authors screened the articles independently and cross-checked their reports on selected articles. The inconsistency among the authors was solved by discussion. Articles with full text were considered for systematic and meta-analysis. The quality of each selected article was assessed carefully by Joana Brigg’s Institute critical appraisal checklist [14,15]. Articles with a total score of 50% and above were classified as having a low risk of bias; otherwise, they were classified as having a high risk of bias [15]. The quality of each paper was evaluated by each author, and discrepancies were solved through discussion.
+
+2.3 Eligibly criteria
+
+2.3.1 Inclusion criteria.
+
+The eligibility criteria were formulated by the review questions. For the prevalence of delayed treatment for malaria, a CoCoPop (Condition, Context, and Population) review question was used and risk factors of delayed treatment for malaria, the review question was PEO (Population, exposure, and Outcome) [16]. Based on these review questions, those that fulfilled the following criteria were incorporated for analysis:
+
+Articles conducted in the horn of Africa on under five children and reported either prevalence of delayed treatment for malaria or associated factors of delayed treatment for malaria or both were included.
+
+Articles conducted or published at any period and with English language were incorporated.
+
+2.3.2 Exclusion criteria.
+
+Articles without full text after emailing the respective authors to obtain the full articles were excluded.
+
+For this review, case reports/case series studies, comments and opinions were excluded.
+
+2.4 Outcome measurement
+
+This systematic review and meta-analysis have two objectives. The first objective was to estimate the pooled prevalence of delayed treatment for malaria among children in the Horn of Africa. The second objective was to identify the associated factors for delayed treatment for malaria. Delayed treatment for malaria is defined as a treatment sought after the recommended 24-hour onset of malaria symptoms [4].
+
+Diagnostic delay refers to the time between the onset of symptoms and the formal diagnosis [17].
+
+2.5 Population
+
+Under five children in the Horn of Africa were the population for the current systematic review and meta-analysis.
+
+2.6 Data extraction and screening results
+
+To extract the data from the selected articles, we have prepared an extraction check list using an Excel spreadsheet. Basically, the data extraction sheet was aimed at answering the question about the prevalence and associated factors of delayed treatment for malaria. The check list consists of the following data elements: publication year, authors, data collection tool, proportion of delayed treatment for malaria, standard error of the proportion, sample size, event (numbers of children with delayed treatment for malaria), study setting, study period, quality score, odds ratio for each predictor, log odds ratio for each predictor, upper confidence interval for odds ratio of each predictor, lower confidence interval for odds ratio of each predictor, ln of both upper confidence interval for odds ratio of each predictor, and standard error for odds ratio for each predictor. Additionally, we have used the JBI (Joana Brigg’s Institute) tool for data extraction [18]. The data extraction was conducted by four pairs of authors, and the discrepancy between the authors was solved by group discussion (the eight authors (Muluken Chanie Agimas, Aysheshim Kassahun Belew, Elsa Awoke Fentie, Lemlem Daniel Baffa, Esmael Ali Muhammad, Berhanu Mengistu, Ever Siyoum Shewarega, Mekuriaw Nibret Aweke). After double-checking the extracted data, the ready file was exported to STATA software version 17.
+
+2.7 Data analysis
+
+To analyze the pooled proportion and odds ratio by the extracted data, STATA software version-17 was used. To assess the index heterogeneity of the included studies the I2 statistics was calculated [19]. The I2 statistics value 25% was low heterogeneity whereas its value of 50%, and 75% was classified as medium and high heterogeneity between the studies respectively [20]. The statistical significance of the heterogeneity between the studies was evaluated by the p-value of I2 with the cut of point less than 0.05 [18]. To manage the heterogeneity between the studies, sensitivity analysis and subgroup analysis by study period (before COVID pandemic and after COVID pandemic) and study setting was conducted. Additionally, the publication bias was assessed by the visual funnel plot test and the second way to manage the small study effect bias was statistical method such as the Egger’s statistics [21]. The random effect model was also used to estimate the pooled prevalence and odds ratio of delayed treatment for malaria with the level of confidence 95% to handle heterogeneity and balancing study weighting. The pooled odds ratio with p-value of less than 0.05 was declared as a statistical predictor for delayed treatment for malaria among under five children in the horn of Africa. Findings such as the pooled prevalence delayed treatment for malaria and its determinants were reported by both the text and the forest plot.
+
+3. Results
+
+3.1 Characteristics of the included articles
+
+Out of the total of 126,989 articles, 119,897 were removed because of duplicates. About 810 records were screened, and 123 of them were assessed for eligibility. Finally, 18 potential studies have been included for systematic review and meta-analysis, as summarized in the PRISMA flow diagram (Fig 1).
+
+10.1371/journal.pone.0333593.g001 Fig 1 PRISMA flow diagram of study selection for pooled prevalence of delay treatment for malaria and its associated factors among children under five in the horn of Africa.
+
+3.2 Characteristics of included studies
+
+All included studies were conducted using a cross-sectional study design. Of the total included studies, the majority, 11 (61.1%) were conducted in facility-based study. The total number of participants included or used for analysis was 64,156, and the minimum and maximum sample sizes used in the studies were 199 [22] and 18,430 [23] respectively. (Table 1).
+
+10.1371/journal.pone.0333593.t001 Table 1 Characteristics of the included studies for delayed treatment of malaria in the horn of Africa.
+
+S.No	Author	Study period	Country	Study setting	Quality	Sample size	Prevalence	
+1	Getahun et al [10].	2010	Ethiopia	facility based	low risk of bias	310	50%	
+2	Megersa Elias Gelchu [24]	2021	Ethiopia	facility based	low risk of bias	565	84.8%	
+3	Daniel S et al [25]	2018	Ethiopia	facility based	low risk of bias	326	40.5%	
+4	Ermias A et al [26]	2014	Ethiopia	facility based	low risk of bias	302	50%	
+5	Olaka W et al [22]	2019	Kenya	facility based	low risk of bias	199	59.8%	
+6	Mitiku and Assefa [27]	2017	Ethiopia	community based	low risk of bias	491	61.3%	
+7	Bolanle. O et al [28]	2022	Ethiopia	community based	low risk of bias	479	65.1%	
+8	Asfa Elnour et al [29]	2017	Sudan	community based	low risk of bias	443	25.1%	
+9	Oryema-Lalobo, Michael [30]	2009	Uganda	community based	low risk of bias	451	20.2%	
+10	Edgar M et al [23]	2023	Uganda	community based	low risk of bias	18,430	63.6%	
+11	Kelly Marie Walters [31]	2016	Uganda	facility based	low risk of bias	325	86.2%	
+12	Arthur M et al [32]	2017	Uganda	facility based	low risk of bias	650	Not reported	
+13	Wakgari D et al [33]	2006	Ethiopia	community based	low risk of bias	2372	9.4%	
+14	Byakika-K et al [34]	2009	Uganda	facility based	low risk of bias	200	34%	
+15	HALIMA M et al [35]	1995	Kenya	facility based	low risk of bias	883	17%	
+16	Rosalind G. et al [36]	1997	Uganda	facility based	low risk of bias	439	89.1%	
+17	Addisu T et al [37]	2020	Ethiopia	facility based	low risk of bias	306	50%	
+18	David B. &Christine A [38]	2021	Uganda	community based	low risk of bias	236	17.8%	
+
+3.3 The pooled prevalence of delayed treatment for malaria in the horn of Africa
+
+By using the random effect model, the pooled prevalence of delayed treatment for malaria among under five children in the Horn of Africa was 48% (95%CI: 34%–63%), and the heterogeneity among the studies was statistically significant (I2 = 98.82%, P-value < 0.001). (Fig 2).
+
+10.1371/journal.pone.0333593.g002 Fig 2 The pooled prevalence of delayed treatment for malaria among children in the horn of Africa.
+
+3.4 Assessment of publication bias
+
+To evaluate the publication bias for the included articles, we used Egger’s statistical test and evidenced that there is no publication bias (β = −5.04, P-value = 0.74) (Fig 3).
+
+10.1371/journal.pone.0333593.g003 Fig 3 Funnel plot of delayed treatment for malaria among children in the horn of Africa.
+
+3.5 Handling heterogeneity
+
+In the random effect model of pooled prevalence, statistically significant heterogeneity was detected. To solve this problem, heterogeneity sensitivity analysis and subgroup analysis were performed.
+
+3.6 Sensitivity analysis
+
+To manage the influence of a single study in meta-analysis estimation (to assess the heterogeneity), the random effects model and sensitivity analysis were conducted, and there was no study that excessively influenced the overall pooled prevalence of delayed malaria treatment (S1 File).
+
+3.7 Subgroup analysis by country
+
+Again, to manage the heterogeneity, the subgroup analysis was conducted by country, and thus the highest prevalence of delayed treatment for malaria among children was observed in Uganda (52% (95%CI: 32%–72%) and the lowest pooled prevalence of delayed malaria treatment was reported in Sudan (13% (95%CI: 21%–29%) with an I2 = 99.82% and a P-value <0.001) (Fig 4).
+
+10.1371/journal.pone.0333593.g004 Fig 4 The pooled prevalence of delayed treatment for malaria by country among children in the horn of Africa, 2023. Note: ES= Effect Size.
+
+3.8 Subgroup analysis by study setting
+
+Subgroup analysis was also carried out in the study setting as a source of heterogeneity. The highest prevalence of delayed treatment for malaria by study setting was observed in a facility-based study (56% (95% CI: 36%–76% with I2 = 99.82%, P-value <0.001) (Fig 5).
+
+10.1371/journal.pone.0333593.g005 Fig 5 The pooled prevalence of delayed treatment for malaria by study setting among children in the horn of Africa, 2023.
+
+3.9 Subgroup analysis by study period
+
+Furthermore, subgroup analysis was carried out during the study period as a source of heterogeneity. Thus, the highest prevalence of delayed treatment for malaria by study period was among studies conducted after the COVID-19 pandemic: 58% (95% CI: 39%–76%, with I2 = 99.82%, P-value <0.001) (Fig 6).
+
+10.1371/journal.pone.0333593.g006 Fig 6 The pooled prevalence of delayed treatment for malaria by study period among children in the horn of Africa, 2023.
+
+3.10 Factors associated with delayed treatment for malaria
+
+As briefly described in Table 2, distance, drug side effects, expensive and optimum transport costs, formal education, and middle income were significantly associated with delayed treatment for malaria among under-five children in the Horn of Africa. From the random effect model estimate, the odds of delayed treatment for malaria among participants who travelled >3000 meters to reach the health institution were 2.59 times higher than <3000 meters (OR = 2.59, 95% CI: 2.03–3.3, I2 = 0%, P-value = 0.689) (Table 2, Fig 7). The pooled odds of delayed treatment for malaria among participants who had a history of drug side effects were 2.94 times higher odds than the counterpart (OR = 2.94, 95% CI: 1.86–4.67, I2 = 89.5%, P-value = 0.002) (Table 2, Fig 8). The pooled odds of delayed treatment for malaria among participants who had formal education were reduced by 31% (OR = 0.69, 95% CI: 0.49–0.96, I2 = 91.4%, P-value<0.001) as compared to those who had no formal education (Table 2, Fig 9). Regarding the cost of transport, participants who paid the expensive and optimum cost for transport were 4.39 (OR = 4.39, 95% CI: 2.49–7.76, I2 = 85.4%, P-value = 0.009) (Table 2, Fig 10) and 2.13 times (OR=2.13, 95% CI: 1.41–3.2 with I2 = 59.3%, P-value = 0.117) (Table 2, Fig 11) higher odds of delay the treatment of malaria, respectively. Additionally, the odds of malaria treatment delay among participants with a middle level of income were reduced by 58% (OR = 0.42, 95% CI: 0.28–0.63, I2 = 26.9%, P-value = 0.242) as compared to those with a poor level of income (Table 2, Fig 12).
+
+10.1371/journal.pone.0333593.t002 Table 2 Summary of factors associated withdelayed treatment for malaria among children in the horn of Africa.
+
+Variable	OR (95%CI)	Heterogeneity (I2, p-value)	Total studies	Sample size	
+Sex	Female	2.69 (0.98, 3.12)	91.8, < 0.001	2	865	
+Male	1	1			
+History of Child death	Yes	2.5 (0.73, 3.59)	31.9, 0.23	3	918	
+No	1	1			
+Distance	>3000 meter	2.59 (2.03, 3.32)	0%, 0.689	2	1286	
+<3000 meter	1	1			
+Drug side effect	Yes	2.94 (1.86, 4.67)*	89.5%, 0.002	2	612	
+No	1	1		2846	
+Cost of transport	Expensive	4.39 (2.49, 7.76)	85.4%, 0.009	2	636	
+Optimum	2.13 (1.41, 3.21)	59.3%, 0.117	2	636	
+Cheap	1.91 (0.98, 3.46)	93.5, < 0.001	2	636	
+No cost	1	1			
+Mothers Educational status	Formal education	0.69 (0.49, 0.96)*	91.4%, < 0.001	3	3239	
+No education	1	1			
+Polygamy	Yes	3.03 (0.98, 4.05)	0%, 0.359	2	960	
+No	1	1			
+Unemployment	Yes	1.23 (0.81, 1.89)	96.2%, < 0.001	2	871	
+No	1	1			
+Income	Middle	0.42(0.28, 0.63)	26.9, 0.242	2	2937	
+Poor	1	1			
+
+10.1371/journal.pone.0333593.g007 Fig 7 Effect of distance >3000 meters on malaria treatment delay among children in the horn of Africa.
+
+10.1371/journal.pone.0333593.g008 Fig 8 Effect of drug side effects on malaria treatment delay among children in the horn of Africa.
+
+10.1371/journal.pone.0333593.g009 Fig 9 Effect of formal education on malaria treatment delay among children in the horn of Africa.
+
+10.1371/journal.pone.0333593.g010 Fig 10 Effect of expensive of transport cost on malaria treatment delay among children in the horn of Africa.
+
+10.1371/journal.pone.0333593.g011 Fig 11 Effect of optimum transport cost on malaria treatment delay among children in the horn of Africa.
+
+10.1371/journal.pone.0333593.g012 Fig 12 Effect of middle level income on malaria treatment delay among children in the horn of Africa.
+
+4. Discussion
+
+Malaria treatment delay is a critical issue in Africa, especially in the Horn of Africa. It is the most common problem because of instability and poverty. To reverse this problem, studies to support decision-making are very important. But there are no sub-national-level studies to estimate the pooled prevalence and factors that affect the malaria treatment delay of under-five children in the Horn of Africa. Therefore, in this study, an attempt has been made to assess the pooled prevalence of malaria treatment delay among under-five children in the Horn of Africa. Thus, despite considerable heterogeneity, the pooled prevalence of delayed treatment for malaria among under-five children in the Horn of Africa was 48% (95% CI: 34%–63%, I2 = 98.82%, p-value < 0.001). It is obvious that, principally, all children with malaria should get treatment as soon as possible. But only 52% of under-five children in the Horn of Africa got prompt malaria treatment. This finding was lower than a study conducted in Myanmar, Southeast Asia, which was 64.7% (18). This can be justified by the variation in the study period. The other possible reason might be associated with the fact that the previous study was conducted exclusively among rural populations. The access to health services and health-seeking behavior among the rural population is relatively low. This leads to a delay in seeking malaria treatment [24]. But it was higher than a study conducted in South Eastern Nigeria 21.4% [39]. This might be because, in this study, we include those articles conducted after COVID-19 with the highest prevalence of delayed treatment for malaria. But a study conducted in south-eastern Nigeria was before the COVID-19 pandemic [39]. This is because the COVID-19 pandemic had a negative effect on health service utilization [40]. A subgroup analysis was carried out by the study period as a source of heterogeneity, and despite considerable heterogeneity, the highest prevalence of delayed treatment for malaria by study period was among studies conducted after the COVID-19 pandemic (58%; 95% CI: 39%–76%, I2 = 99.82%, P-value <0.001). This might be because during the COVID-19 pandemic, the health institutions were focused on COVID-19 treatment and screening, but other health services were neglected [41].
+
+Regarding factors associated with delayed treatment for malaria among children under five, despite considerable heterogeneity among studies, as the distance to reach the health facility is far, the risk of delay in seeking malaria treatment is increased (OR = 2.59, 95% CI: 2.03–3.3, I2 = 0%, p-value = 0.689). The finding was supported by a study conducted in Yemen and India [42,43] (17, 18). This may be related to the fact that accessing health services becomes more difficult the farther one must travel to get to the facility, and that physical accessibility is typically a problem for remote areas [44]. Poor media availability, a lack of health-seeking behavior, and the need to travel far to receive medical care disadvantage this population segment. All these factors contribute to the delay in diagnosing and treating malaria in children under five in the Horn of Africa.
+
+Educational attainment is another factor that influences the treatment delay of malaria in children under five in the Horn of Africa. Compared to women without formal education, those with formal education have the lowest odds of delaying treatment for malaria, despite significant variation across studies (OR = 0.69, 95% CI: 0.49–0.96, I2 = 91.4%, p-value<0.001). This finding was supported by a study conducted in Myanmar [45]. This may be related to educational attainment, which has a significant impact on women’s health-seeking behavior. Women with low literacy levels are less likely to seek medical attention early because they are unaware of the warning signs and symptoms of malaria [46]. Education can also lead to more accurate health beliefs and knowledge and thus to better lifestyle choices, better skills, and greater self-advocacy. Education improves skills such as literacy, develops effective habits, and may improve the cognitive ability to decide on the early treatment of malaria. Furthermore, educated women may be more able to understand their health needs, follow instructions, advocate for themselves and their families, and communicate effectively with health providers [47].
+
+Regarding level of income, parents with a middle level of income have lower odds of delaying the treatment and diagnosis of malaria for their child than parents with a poor level of income (OR = 0.42, 95% CI: 0.28–0.63, I2 = 26.9%, p-value = 0.242). This finding was supported by a study conducted in China [48]. This might be associated with income having significant gradients in multiple measures of healthcare-seeking behavior. Wealth can give a person the freedom to choose how to live a healthy life without being constrained by financial problems to get health services early.
+
+The cost of transport to reach the health institution is also another reason for delayed treatment for malaria among children in the Horn of Africa. This is because mothers of children with the highest and optimum cost of transportation to reach the health institutions have a higher risk of delayed treatment for malaria than women of children with no cost of transportation [10]. Furthermore, women who complained about the side effects of the malaria drug, which was ordered by the health professionals in the previous illness of the current child, were at higher risk of being delayed in seeking treatment for malaria among children under five in the Horn of Africa. This might be associated with inadequate health education and instructions about the general information and side effects of malaria drugs by the health providers, which leads the women to believe that the side effects or adverse effects of malaria drugs are more harmful than their beneficial effects. Thus, adequate counselling and information for the women could improve the misunderstanding about the drug. To do this, all the physicians, pharmacists, and caretakers should take responsibility for promoting the early treatment and diagnosis of malaria through education initiatives to identify early signs of malaria and seek treatment as soon as possible. Furthermore, working with local health workers and incorporating malaria education into regular medical visits can facilitate prompt diagnosis and treatment. This study has an important implication for the body of knowledge by giving an insight into the factors contributing to delayed treatment for malaria among children. This knowledge is an important tool for decision-makers to design evidence-based strategies to reduce delays in malaria treatment and diagnosis in the Horn of Africa. This systematic review and meta-analysis had considerable strengths and limitations. Since it is the first-level study in the Horn of Africa, it provides important updated knowledge about why parents delay seeking treatment and diagnosis of malaria. Previous studies did not answer this question. Also, by providing evidence-based insights, studies have shaped interventions, optimized resource allocation, and addressed emerging challenges like insecticide resistance. Despite this strength, the current study includes only quantitative observational studies published in English, which may underestimate the pooled prevalence of delay in seeking treatment and diagnosis of malaria among under-five children in the Horn of Africa. Additionally, the author tried to manage heterogeneity, but variability or differences among the studies makes it hard to interpret the finding. Furthermore, since systematic reviews take time, new studies may be published during or after the review process that could alter the conclusions.
+
+5. Conclusion
+
+In the Horn of Africa, for every two parents, approximately one parent delayed seeking treatment for malaria. Factors like fear of side effects from drugs, distance to reach the health facility >3000 meters, and expensive and optimum cost of transport were the risk factors for delayed treatment for malaria among children in the Horn of Africa. Whereas the middle level of income was the protective factor for delayed treatment for malaria among children, thus, expanding health education and improving financial and physical accessibility of health services are highly recommended to reduce treatment delays.
+
+6. Consent for publication
+
+Not applicable.
+
+Supporting information
+
+S1 File Sensitivity analysis plot.
+
+(PDF)
+
+S1 Checklist PLOSOne clinical studies checklist for early PNC.
+
+(DOCX)
+
+S2 Checklist PRISMA 2020 checklist.
+
+(DOCX)
+
+S3 Checklist STROBE checklist.
+
+(DOCX)
+
+The authors acknowledged the University of Gondar for facilitating training on meta-analysis.
+
+Abbreviations
+
+CI Confidence Interval
+
+COVID-19 Corona Virus Disease 2019
+
+JBI Joana Brigg’s Institute
+
+OR Odds Ratio
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols.
+
+DOI: 10.1371/journal.pone.0333593.r001
+
+Decision Letter 0
+
+Arab-Zozani Morteza Academic Editor
+Copyright: © 2025 Morteza Arab-Zozani
+Copyright year: 2025
+Copyright holder: Morteza Arab-Zozani
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 0
+
+4 Mar 2025
+
+PONE-D-24-08743Prevalence and determinants of delay in seeking malaria treatment and diagnosis among under five children in the Horn of Africa: A systematic review and meta-analysisPLOS ONE
+
+Dear Dr. Agimas,
+
+Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
+
+==============================Dear Respectable AuthorsWe have reached a decision regarding your manuscript based on the reviewers' comments.Please respond to the reviewers' comments as soon as possible and submit the response to the reviewers' file separately. In addition, highlight the changes in the text of the manuscript with yellow highlighter.Our decision is: Major revision==============================
+
+Please submit your revised manuscript by Apr 18 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.
+
+Please include the following items when submitting your revised manuscript:
+
+A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
+
+A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
+
+An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.
+
+If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.
+
+If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .
+
+We look forward to receiving your revised manuscript.
+
+Kind regards,
+
+Morteza Arab-Zozani, Ph. D.
+
+Academic Editor
+
+PLOS ONE
+
+Journal requirements: 
+
+When submitting your revision, we need you to address these additional requirements.
+
+1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at
+
+https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and
+
+https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf .
+
+2. As required by our policy on Data Availability, please ensure your manuscript or supplementary information includes the following:
+
+A numbered table of all studies identified in the literature search, including those that were excluded from the analyses. 
+
+For every excluded study, the table should list the reason(s) for exclusion. 
+
+If any of the included studies are unpublished, include a link (URL) to the primary source or detailed information about how the content can be accessed.
+
+A table of all data extracted from the primary research sources for the systematic review and/or meta-analysis. The table must include the following information for each study:
+
+Name of data extractors and date of data extraction
+
+Confirmation that the study was eligible to be included in the review. 
+
+All data extracted from each study for the reported systematic review and/or meta-analysis that would be needed to replicate your analyses.
+
+If data or supporting information were obtained from another source (e.g. correspondence with the author of the original research article), please provide the source of data and dates on which the data/information were obtained by your research group.
+
+If applicable for your analysis, a table showing the completed risk of bias and quality/certainty assessments for each study or outcome.  Please ensure this is provided for each domain or parameter assessed. For example, if you used the Cochrane risk-of-bias tool for randomized trials, provide answers to each of the signalling questions for each study. If you used GRADE to assess certainty of evidence, provide judgements about each of the quality of evidence factor. This should be provided for each outcome. 
+
+An explanation of how missing data were handled.
+
+This information can be included in the main text, supplementary information, or relevant data repository. Please note that providing these underlying data is a requirement for publication in this journal, and if these data are not provided your manuscript might be rejected. 
+
+3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.
+
+[Note: HTML markup is below. Please do not edit.]
+
+Reviewers' comments:
+
+Reviewer's Responses to Questions
+
+Comments to the Author
+
+1. Is the manuscript technically sound, and do the data support the conclusions?
+
+The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.
+
+Reviewer #1: Partly
+
+Reviewer #2: Yes
+
+**********
+
+2. Has the statistical analysis been performed appropriately and rigorously?
+
+Reviewer #1: Yes
+
+Reviewer #2: Yes
+
+**********
+
+3. Have the authors made all data underlying the findings in their manuscript fully available?
+
+The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.
+
+Reviewer #1: No
+
+Reviewer #2: Yes
+
+**********
+
+4. Is the manuscript presented in an intelligible fashion and written in standard English?
+
+PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.
+
+Reviewer #1: Yes
+
+Reviewer #2: Yes
+
+**********
+
+5. Review Comments to the Author
+
+Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
+
+Reviewer #1: Why is this review limited to studies conducted in the Horn of Africa?
+
+There is no reference for the first statement in the second paragraph of your introduction, lines 82-84.
+
+In Lines 86-88, the authors wrote: “In African countries, 87 like Kenya, the meta-analysis report showed that only 5% of malaria patients are receiving treatment early 88 (3)”. However, the ref (3) provided is not a meta-analysis. Here is your reference 3:
+
+Giannone, B., et al., Imported malaria in Switzerland,(1990–2019): A retrospective analysis. 2022. 45: p. 102251.
+
+It seems the authors have lost track of some citations. Please, revise all citations and ensure you have referenced them correctly.
+
+Based on the search strategy provided by the authors, I think it’s too shallow and perhaps, explains where there were few included studies. No effort at citation tracking was even employed.
+
+Please, let your reader know the categories of the JBI scoring you used.
+
+Please, credit the CoCoPop and PEO creators whose ideas you applied. Here is one reference;
+
+Munn, Z., Stern, C., Aromataris, E., Lockwood, C. & Jordan, Z. What kind of systematic review should I conduct? A proposed typology and guidance for systematic reviewers in the medical and health sciences. BMC Med. Res. Methodol. 18, 5 (2018).
+
+In lines 134-15, the authors have contradicted themselves by writing: “Studies conducted with Crossectional, case control, cohort and experimental study design were “illegible” for this review. “
+
+Please, also give credit to who is due. Here is the reference for the JBI data extraction you used. Please cite it:
+
+Munn, Z., Tufanaru, C. & Aromataris, E. JBI’s systematic reviews: data extraction and synthesis. Am. J. Nurs. 114, 49–54 (2014).
+
+Please, review line 156-160.
+
+State precisely how you calculated each of your study’s two outcomes; and what data you used from the primary studies to get that.
+
+Please review your I2 values of 255, 50%, and 75% as you wrote them in the statistics section. That’s not accurate as they are in ranges.
+
+Please cite the reference for your Egger’s test and Funnel plot analyses.
+
+You have not stated why you used a random effects model meta-analysis only
+
+Your methods section did not note subgroup analysis with reference to the COVID-19 periods.
+
+In your sensitivity, analysis report, write out the range for maximum and minimum pooled prevalence indicating which study was removed to arrive at that particular pooled rate and include the p-value.
+
+There seems to be a problem with the last column of your Table 3.
+
+There are many references without journal names. Please revise this
+
+In the Discussion, you wrote: “But a study 314 conducted in south-eastern Nigeria was before the COVID-19 pandemic.” which study is this and where is its reference?
+
+Please, note that you must provide a reference for all affirmative statements you made.
+
+Of the many limitations to this review, the authors only stated one. Please discuss other limitations to this report.
+
+I look forward to reading the revised version of this manuscript.
+
+Reviewer #2: This manuscript addresses an important public health issue—delays in seeking malaria treatment for children under five in the Horn of Africa. The study follows a systematic review and meta-analysis approach, synthesizing data to estimate the prevalence of delayed malaria treatment and its associated factors. The topic is relevant, and the authors provide numerical evidence to support their conclusions.
+
+However, the manuscript requires minor revisions to improve clarity, coherence, and scientific rigor. Key areas needing improvement include language precision, structure, clarity in statistical reporting, and discussion.
+
+While the manuscript is understandable, some grammatical errors needs correction and scanty detail should be work on to improve readability
+
+The manuscript does not specify the exact search timeframe. The authors should clarify the range of years considered for inclusion.
+
+The inclusion/exclusion criteria are not explicitly listed in a structured format.
+
+While the analysis is rigorous, some results lack proper interpretation.
+
+The study reports odds ratios (ORs) but does not sufficiently explain their meaning in context.
+
+Heterogeneity assessment needs more discussion. The I² value should be reported numerically. The discussion should clearly link the results to policy implications and practical recommendations.
+
+Vague recommendations, e.g., "expanding health education" needs improvement. Authors should consider discussions on lack of health system constraints.
+
+Use consistent tense throughout the manuscript (switching between past and present tenses should be avoided).
+
+**********
+
+6. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.
+
+If you choose “no”, your identity will remain anonymous but your review may still be made public.
+
+Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .
+
+Reviewer #1: Yes:  Dr Sahabi Kabir Sulaiman
+
+Reviewer #2: No
+
+**********
+
+[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]
+
+While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step.
+
+Attachment Submitted filename: Malaria treatment delay manscript_1.docx
+
+DOI: 10.1371/journal.pone.0333593.r002
+
+Author response to Decision Letter 1
+
+Submission Version: 1
+
+5 Jun 2025
+
+uploaded.
+
+Attachment Submitted filename: Point-by-point response to reviewers.pdf
+
+DOI: 10.1371/journal.pone.0333593.r003
+
+Decision Letter 1
+
+Birru Eshetie Melese Academic Editor
+Copyright: © 2025 Eshetie Melese Birru
+Copyright year: 2025
+Copyright holder: Eshetie Melese Birru
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 1
+
+5 Aug 2025
+
+PONE-D-24-08743R1Prevalence and determinants of delay in seeking malaria diagnosis and treatment among under five children in the Horn of Africa: A systematic review and meta-analysisPLOS ONE
+
+Dear Dr. Agimas,
+
+Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
+
+Please submit your revised manuscript by Sep 19 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.
+
+Please include the following items when submitting your revised manuscript:
+
+A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
+
+A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
+
+An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.
+
+If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.
+
+If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .
+
+We look forward to receiving your revised manuscript.
+
+Kind regards,
+
+Eshetie Melese Birru, PhD
+
+Academic Editor
+
+PLOS ONE
+
+Journal Requirements:
+
+If the reviewer comments include a recommendation to cite specific previously published works, please review and evaluate these publications to determine whether they are relevant and should be cited. There is no requirement to cite these works unless the editor has indicated otherwise. 
+
+Additional Editor Comments:
+
+Major Comments and Suggestions
+
+1. Conceptual and Analytical Clarity
+
+• The manuscript conflates "diagnostic delay" and "treatment delay" throughout. These are distinct constructs and must be clearly defined and consistently used.
+
+• The rationale for grouping countries in the Horn of Africa as a single analytical unit should be strengthened. Please justify this approach in light of their substantial health system, geographic, and sociopolitical diversity.
+
+2. Search Strategy and Selection Criteria
+
+• Your search strategy lacks critical detail. Please clearly list the exact search strings, date of last search for each database, and number of hits per database.
+
+• The use of only English-language articles should be acknowledged as a limitation due to potential language bias.
+
+• It is unclear why a 50% threshold on the JBI tool was used to assess study quality. Please provide a rationale or reference.
+
+3. Statistical Analysis and Heterogeneity
+
+• The reported I² of 98.8% indicates substantial heterogeneity, yet the implications are not critically discussed. Please address the impact of this heterogeneity on the validity of your pooled estimate.
+
+• While subgroup analyses are conducted, no meta-regression was attempted to explore multiple sources of variability. Please consider this or explain its omission.
+
+4. Definition and Classification of Key Variables
+
+• Definitions for categories such as "expensive" and "optimum" transport cost, or "middle income," are unclear. Clarify how these were determined and whether definitions were consistent across included studies.
+
+5. Presentation of Results
+
+• Figures are not integrated within the main manuscript. Please ensure that all referenced figures (e.g., forest plots, funnel plots) are embedded and clearly labeled.
+
+• Table 3 is difficult to read due to formatting issues. Please revise it to ensure clarity and alignment of variables, estimates, and confidence intervals.
+
+6. Language and Typographical Issues
+
+• The manuscript contains numerous grammatical, typographic, and formatting issues that impede readability. Common issues include incorrect punctuation, inconsistent capitalization, subject–verb agreement errors, and awkward phrasing.
+
+• We recommend a thorough language and editorial review, preferably with assistance from a professional editor or fluent English speaker.
+
+7. Contextualization and Literature Integration
+
+• The discussion lacks sufficient comparison with existing literature beyond a few regional studies. Please strengthen this section by incorporating relevant global and regional findings to contextualize your results.
+
+• Assertions regarding the impact of COVID-19 on treatment delays should be supported by references or data.
+
+________________________________________
+
+Minor Comments
+
+• Standardize formatting of headings and subheadings according to PLOS ONE style.
+
+• Ensure all acronyms (e.g., JBI, OR) are defined on first use.
+
+• Please reword the conclusion to avoid repetition and to clearly articulate the key public health implications of your findings.
+
+________________________________________
+
+Reviewers' comments:
+
+Reviewer's Responses to Questions
+
+Comments to the Author
+
+1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.
+
+Reviewer #2: All comments have been addressed
+
+Reviewer #3: (No Response)
+
+Reviewer #4: (No Response)
+
+**********
+
+2. Is the manuscript technically sound, and do the data support the conclusions?
+
+The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.
+
+Reviewer #2: Yes
+
+Reviewer #3: Partly
+
+Reviewer #4: Yes
+
+**********
+
+3. Has the statistical analysis been performed appropriately and rigorously?
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+Reviewer #4: Yes
+
+**********
+
+4. Have the authors made all data underlying the findings in their manuscript fully available?
+
+The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+Reviewer #4: Yes
+
+**********
+
+5. Is the manuscript presented in an intelligible fashion and written in standard English?
+
+PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.
+
+Reviewer #2: Yes
+
+Reviewer #3: No
+
+Reviewer #4: No
+
+**********
+
+6. Review Comments to the Author
+
+Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
+
+Reviewer #2: (No Response)
+
+Reviewer #3: Despite not being an original prevalence study, but a quantitative analysis of published studies, the authors are able to obtain the data to demonstrate the frequency of delay in malaria treatment among children in the Horn of Africa and the associated factors. The results are worrying and deserve to be publicized to alert authorities and encourage resolutive actions in the evaluated region. Some suggestions:
+
+ABSTRACT – “Anopheles” should be in italics.
+
+INTRODUCTION
+
+Line 74 - “Anopheles” must be in italics and started with a capital “A”.
+
+Lines 74, 75, 84 – "Anopheles" and "Plasmodium falciparum" must be in italics and capitalized.
+
+Line 85 – “As evidenced by a national study,…” – Where is the study from?
+
+METHODOLOGY
+
+Searching strategy – I considered it a good strategy and a good following entry terms
+
+As this is not a longitudinal study, I suggest that the authors do not use the term “risk factors” anywhere in the text. Instead, use “factors associated” with delayed treatment for malaria
+
+OUTCOME MEASUREMENTS - Line 146 – The explanation of OR is unnecessary
+
+RESULTS
+
+Line 192-193 – The authors wrote that “Of the total included studies, the majority, 28 (65.1%) were conducted in an urban setting”. If 28 studies are 65.1%, the total number of studies should be 43. However, the number of studies included was 18. I may not have understood clearly, but I suggest checking this information.
+
+Table 3 is unconfigured.
+
+Don't the authors think that “child death” should be excluded from the factors associated with delayed treatment for malaria? This seems more related to a consequence rather than a cause.
+
+Does the Education variable refer to the mother's education? I suggest making it clear.
+
+Fig. 2 – I suggest deleting and keeping only Fig 4.
+
+Fig 4 - I suggest putting the meaning of “ES” under the figures.
+
+I didn't find Figure 6. Would Fig 7 be 6?
+
+All figures have two titles. I suggest choosing the title below the figures.
+
+The number of figures (12!) is disproportionate to the magnitude of the results – it doesn't make sense. Authors can describe the results in the text and use a maximum of 2 to 3 figures to complement or clarify some relevant information. Another possibility would be a single figure referring to “Effect of the studied variables on malaria treatment delay” and presenting quadrants (a, b, c…) with the significant results including their respective significance levels.
+
+DISCUSSION
+
+Line 350 – Check the word “drug” – Wouldn’t it be “drug”?
+
+The discussion was coherent, the authors pointed out the limitation of the study.
+
+Reviewer #4: Dear Editor,
+
+Thank you for inviting me to review this research work. It addresses an important topic and provides evidence on the need to tackle delayed malaria diagnosis and treatment seeking among children under five. Nonetheless, the following minor revisions are needed to provide more clarity on methodology, definition and writing.
+
+Comments to authors
+
+1. In L 187 and 191, authors need to justify the mention of “lowest prevalence of undiagnosed hypertension was reported in Sudan”? Are these sections from another paper?
+
+2. More than 90% of searched articles were removed due to duplicates. Please, authors need to explain in the methodology how they proceeded to remove duplicates. Additionally, authors should be consistent in writing: example 126,989 vs 119897
+
+3. The title of the study mentions ''delay in seeking malaria diagnosis and treatment’’. However, the results showed only delayed treatment. Is the definition of delayed treatment in L 115-116 limited to clinical symptoms or after a test has confirmed Plasmodium infection?
+
+4. In L 153, it would be better to rewrite the subheading as “Screening results” since you did not describe articles in this section.
+
+5. L 50: Keywords may be in alphabetical order
+
+6. Write scientific names in italics in L 52-53.
+
+7. In L 82, could the authors explain the importance of the clause “it took one month to search articles” when the authors already mentioned the dates?
+
+8. L 213-214: The sentence “The pooled odds of delayed treatment for malaria among participants who had a history of drug side effects were 2.94 times more likely than the counterpart” is difficult to understand. More likely is not suitable for comparison of odds ratios between groups.
+
+9. For readability, authors may consider checking the punctuations throughout the manuscript.
+
+10. The authors should be consistent with tenses used in the manuscript. It would be better to use past tenses.
+
+11. Some sentences and English used need to be improved in this manuscript, example L 274.
+
+12. Check for typo errors and sentence clarity like in L 313-318 and other parts as well.
+
+13. L 319: “To do this, all the physicians, pharmacists, and caretakers should take responsibility for promoting the early treatment and diagnosis of malaria”. Could the authors provide information on how this can be done?
+
+**********
+
+7. PLOS authors have the option to publish the peer review history of their article (what does this mean? ). If published, this will include your full peer review and any attached files.
+
+If you choose “no”, your identity will remain anonymous but your review may still be made public.
+
+Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy .
+
+Reviewer #2: No
+
+Reviewer #3: No
+
+Reviewer #4: No
+
+**********
+
+[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]
+
+While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step.
+
+DOI: 10.1371/journal.pone.0333593.r004
+
+Author response to Decision Letter 2
+
+Submission Version: 2
+
+15 Sep 2025
+
+Attached.
+
+Attachment Submitted filename: Point-by-point_response_to_reviewers_auresp_2.pdf
+
+DOI: 10.1371/journal.pone.0333593.r005
+
+Decision Letter 2
+
+Birru Eshetie Melese Academic Editor
+Copyright: © 2025 Eshetie Melese Birru
+Copyright year: 2025
+Copyright holder: Eshetie Melese Birru
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 2
+
+16 Sep 2025
+
+Prevalence and associated factors of delay in seeking malaria treatment among under five children in the Horn of Africa: A systematic review and meta-analysis
+
+PONE-D-24-08743R2
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+Dear Dr. Agimas,
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+References
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Adv Nurs
+Journal ID: J Adv Nurs
+NLM Journal ID: 7609811
+Journal ID: JAN
+
+Journal of Advanced Nursing
+
+ISSN: 0309-2402
+EISSN: 1365-2648
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13069252
+PMID: 40913019
+DOI: 10.1111/jan.70208
+Article ID: JAN70208
+Article ID: JAN-2025-0268.R2
+Article version: 1
+Subjects: Scoping Review, Scoping Review
+
+Exploring the Role of Primary Care Nurses in Dietary Management for Migrants With Diabetes: A Scoping Review
+
+Silang Keycee https://orcid.org/0009-0007-5681-6462 1 keyceesilang@outlook.com
+
+Mbuzi Vainess 2
+Graham Coralie 1 3
+East Leah 2 4
+1 School of Nursing and Midwifery University of Southern Queensland Toowoomba Queensland Australia
+2 School of Nursing and Midwifery, Centre for Health Research University of Southern Queensland Toowoomba Queensland Australia
+3 University of Southern Queensland. Toowoomba Queensland Australia
+4 School of Health University of New England Armidale New South Wales Australia
+* Correspondence:
+Keycee Silang (keyceesilang@outlook.com)
+
+Electronic publication date: 2025 Sep 5
+Print publication date: 2026 May
+Volume: 82
+Issue: 5
+Issue title: Special Issue: Doctoral Education in Nursing
+First page: 4660
+Last page: 4681
+Revised 2025 Aug 24; Received 2025 Jan 22; Accepted 2025 Aug 26
+Copyright: © 2025 The Author(s). Journal of Advanced Nursing published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: cultural issues, diabetes, health promotion, migrant health, nurse roles, nurse–patient relationships, primary care
+Figure count: 1
+Table count: 6
+Page count: 22
+
+source-schema-version-number: 2.0
+cover-date: May 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.7.3 mode:remove_FC converted:11.04.2026
+
+Silang, K. , V. Mbuzi , C. Graham , and L. East . 2026. “Exploring the Role of Primary Care Nurses in Dietary Management for Migrants With Diabetes: A Scoping Review.” Journal of Advanced Nursing 82, no. 5: 4660–4681. 10.1111/jan.70208.PMC13069252 40913019
+
+Funding: The authors received no specific funding for this work.
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Aim(s)
+
+To explore how primary care practitioners, including nurses, provide dietary diabetes management to migrants.
+
+Design
+
+The scoping review followed, a refined and structured methodological framework and adhered to the Joanna Briggs Institute Scoping Review guidelines.
+
+Methods and Data Sources
+
+Searches were conducted across CINAHL, PubMed, and Scopus databases to identify studies published between 2000 and 2024 that focus on dietary diabetes care for migrants in Primary Health Care settings. Data were synthesised using thematic analysis.
+
+Results
+
+The search identified 377 studies, with 30 meeting the inclusion criteria. Analysis revealed four themes: (1) cultural influences on diabetes management, (2) culturally tailored dietary interventions, (3) communication challenges and (4) access and availability of diabetes care.
+
+Conclusion
+
+Culturally competent primary care practices are crucial for effective diabetes dietary management for migrants, as they can enhance patient engagement, adherence, and overall health outcomes. Primary care nurses are uniquely positioned to address the barriers experienced by migrant populations through tailored care delivery.
+
+Implications for Patient Care
+
+The findings provide actionable guidance for nurses to implement targeted and culturally responsive approaches in delivering dietary diabetes management, aiming to improve patient adherence and health outcomes among migrants.
+
+Impact
+
+This review identified significant literature gaps in how primary care nurses provide culturally responsive dietary guidance for migrant patients with diabetes. The four themes identified have emphasised the need for culturally preserving care to enhance patient engagement and adherence to clinical guidance. The findings will directly impact nursing practice, education, and clinical guidelines globally, enabling nurses to deliver more effective and culturally responsive diabetes care that improves diabetes‐related disparities among migrants globally.
+
+Reporting Method
+
+The review adhered to PRISMA‐Sc guidelines.
+
+Patient or Public Contribution
+
+No patient or public contribution. This review received no funding from public, commercial or not‐for‐profit sectors.
+
+Summary
+
+What is already known ○ Primary health care nurses are central to chronic disease management, but their role in culturally tailored dietary diabetes care for migrants remains underexplored.
+
+○ Migrant patients face cultural, linguistic, and systemic barriers that affect dietary management in diabetes care.
+
+○ Culturally responsive care can improve engagement and adherence among migrant patients.
+
+What this paper adds ○ Culturally tailored dietary diabetes care provided by primary health care nurses is pivotal for improving engagement, adherence, and outcomes among migrant populations.
+
+○ Highlights that primary health care nurses can improve dietary adherence by adapting education to cultural food traditions, practices, and preferences.
+
+○ Identifies nursing‐led strategies such as culturally adapted resources, bilingual education sessions, and community‐based partnerships to address barriers in migrant diabetes care.
+
+Implications for Practice/Policy ○ Primary health care nurses should be supported to deliver culturally preserving dietary care through responsive cultural competency training and resource provision.
+
+○ Health services should embed nurse‐led, culturally responsive dietary interventions into routine primary health care diabetes management.
+
+○ National and global diabetes policies should recognise and resource the pivotal role of primary health care nurses in reducing disparities for migrant populations.
+
+1 Introduction
+
+The World Health Organisation (WHO) estimates that approximately 830 million people worldwide are living with diabetes (WHO 2024). Similarly, in 2021, an estimated 1 in 20 Australians (just over 1.3 million) were living with Type 1 and Type 2 diagnosed diabetes (Australian Institute of Health and Welfare 2024). However, diabetes prevalence is not uniform across population groups, with migrant populations showing a notably higher burden of disease. Research indicates that migrants exhibit significantly higher diabetes prevalence, with rates in some groups more than double those of Australian‐born individuals (Abouzeid et al. 2013). Globally, the burden of diabetes is also consistently higher among migrants than native‐born populations, as observed in regions such as Europe, Oceania, and America (Montesi et al. 2016; Rawal et al. 2021). The onset of diabetes, particularly Type 2 diabetes mellitus (T2DM), often occurs 5–10 years earlier in migrant populations, with increased incidence of chronic complications (Montesi et al. 2016).
+
+The disproportionate burden of diabetes (Type 1 and 2) among migrants highlights the need for tailored dietary management that is culturally relevant and adaptable to diverse settings. Primary Health Care (PHC) practitioners, particularly nurses, are well‐positioned worldwide to deliver culturally responsive diabetes care due to their continuous patient relationships, community‐based roles, and accessibility. However, the role of PHC nurses in delivering this care remains underexplored globally, despite shared challenges across health systems. This scoping review aims to synthesise literature on PHC practices in dietary diabetes management for migrants. The review seeks to identify key facilitators and barriers in PHC practice to optimise PHC dietary management among migrant populations. The findings have potential applicability across global contexts with diverse populations, offering transferable strategies for strengthening culturally responsive PHC nursing practice.
+
+2 Background
+
+Effective dietary management is a cornerstone of diabetes care, as it can enhance glycaemic control, reduce reliance on medications, and lower the risk of diabetes‐related complications (Evert et al. 2019). Literature underscores key dietary management that promotes the intake of vegetables, fruits, whole grains, lean protein, and legumes (Forouhi et al. 2018). In contrast, the intake of processed foods, particularly refined grains and red meat, has been found to elevate insulin and glucose responses, increasing the risk of pancreatic stress and Type 2 diabetes (Kim et al. 2016).
+
+Research on a low‐carbohydrate diet for diabetes management is plentiful, with consensus showing significant improvement in diabetes‐related biometrics such as HbA1c, fasting glucose, and triglyceride levels (Salvia and Quatromoni 2023). The importance of macronutrient regulation in diabetes management is well recognised, with literature suggesting that optimising the intake of other macronutrients (e.g., protein, fat, fibre) to meet a patient's individual energy needs can positively influence glucose homeostasis, lipid profile, and body composition (Gupta et al. 2018).
+
+Although the role of dietary management in diabetes care is widely acknowledged, migrant populations face unique challenges in adhering to dietary recommendations due to the complex interplay of social, cultural, and linguistic factors that influence their health habits. Migrants often struggle with cultural food preservation while adjusting to new dietary norms in their host country, as traditional diets often consist of high carbohydrate and sugar content (Li‐Geng et al. 2020). This traditional diet is often in conflict with Western diabetes dietary guidelines, posing a significant obstacle to adherence within migrant populations (Kim 2023).
+
+A key socio‐cultural factor is the role of food in social comfort and enjoyment, with communal eating and family gatherings as cultural norms (Li‐Geng et al. 2020). The dietary modifications required for those with diabetes can complicate social interactions and family dynamics (Kim 2023). Dietary modifications can create a sense of isolation during shared or communal meals, as patients with diabetes may feel excluded or worry about disrupting traditional food practices. Adhering to dietary modifications can also impose emotional stress, with patients expressing their concerns with being “a burden” to their families (Li‐Geng et al. 2020). The disconnection from cultural traditions can result in loss of cultural identity, which impacts emotional and social well‐being. In addition to cultural challenges, migrants also encounter barriers related to low English proficiency and health literacy, and limited access to services and healthier alternatives (Li‐Geng et al. 2020). This further complicates navigating healthcare systems, leading to suboptimal health seeking behaviours and increased risk of diabetes complications (Rizqillah and Ma'rifah 2020).
+
+As migration continues to rise globally, the need for culturally preserving healthcare becomes increasingly pivotal. Pettersson et al. (2023) found that the nutrition guidance provided to migrants often lacks cultural sensitivity, resulting in poor adherence and ineffective self‐care practices. Research indicates that migrants are more likely to adhere to dietary recommendations that promote cultural identity preservation (Kohinor et al. 2011). Given the critical role of culturally competent diabetes care, PHC nurses are uniquely positioned to deliver dietary guidance that facilitates cultural preservation.
+
+While the involvement of general practitioners and dietitians in diabetes care is well established, the role of PHC nurses remains underexplored (Farzaei et al. 2023). PHC nurses are pivotal in chronic disease management due to their regular interactions with primary care patients. However, little is known regarding the strategies they implement to tailor dietary counselling to the varying cultural needs of migrants. The role of PHC nurses extends beyond clinical duties, also encompassing patient education, health promotion, and assisting patients with navigating self‐management practices (Alshammari et al. 2021). Given the limited understanding of the role of PHC nurses in delivering dietary diabetes care to migrant populations, a scoping review was undertaken to explore the existing literature.
+
+3 The Review
+
+3.1 Aim
+
+The aim of this study was to examine the existing literature on how PHC practitioners, particularly nurses, deliver dietary diabetes management for migrant populations. The review seeks to identify current management, facilitators, and barriers to practice, and other socio‐cultural factors that impact dietary care for migrants with diabetes.
+
+3.2 Design
+
+The scoping review was conducted following the framework established by Arksey and O'Malley (2005) and further refined by Levac et al. (2010). Additionally, the Joanna Briggs Institute (JBI) Scoping Review guidelines (Peters et al. 2020) were adhered to throughout the review process. The research question guiding this review was “How do Primary Health Care (PHC) practitioners, particularly nurses, deliver dietary management to migrant populations with diabetes?”. No protocol was registered.
+
+3.3 Search Methods
+
+Following the JBI Evidence Synthesis framework (Peters et al. 2020), a comprehensive literature search was conducted in June 2024 using three databases: CINAHL, PubMed, and Scopus. The initial search specifically focused on identifying literature that examined the role of primary care nurses in delivering dietary diabetes management to migrant populations. However, due to the limited literature yielded from the initial search focused on primary care nurses, the inclusion criteria were broadened to include studies involving other PHC practitioners to capture a more comprehensive understanding of current PHC diabetes practice.
+
+The search strategy was informed by the Population, Concept, and Context (PCC) framework outlined by the JBI (Peters et al. 2020). From the initial search of titles and abstracts, a list of key terms and Medical Subject Headings (MeSH) was compiled. Terms related to migrant populations included “migrant*”, “immigrant*”, “foreign*”, “transients and migrants” [MeSH], “emigrants and immigrants” [MeSH], “ESL” and “English as a second language”. The concept terms focused on diabetes and dietary care, such as “diabetes”, “diabetes mellitus” [MeSH], “diabetic*”, “diabetes management” and “management of diabetes”. Context terms included “primary care”, “primary health care” [MeSH], “practice nurse” and “community care”. Terms related to the provider role focused on nursing, including “nurse”, “nurses”, “nursing” and “nurses” [MeSH].
+
+Boolean operators (AND, OR) and truncation were used to combine terms across concepts. For example, a representative search string in PubMed included: (“Nurses”[Mesh] OR nurse* OR nursing) AND (“Diabetes Mellitus”[Mesh] OR diabetes OR diabetic*) AND (“Transients and Migrants”[Mesh] OR migrant* OR immigrant* OR foreign* OR ESL OR “English as a second language”). In CINAHL, both subject headings and keyword terms were used similarly. In Scopus, the search was conducted using both indexed subject terms and by scanning the title, abstract, and keywords to ensure comprehensive coverage of relevant studies. The search was limited to studies published in English between 2000 and 2024. Only peer‐reviewed journal articles, including qualitative, quantitative, and mixed‐methods studies, as well as systematic and scoping reviews, were included. The detailed search terms and strategy are outlined in Appendix A.
+
+3.4 Inclusion and Exclusion Criteria
+
+The inclusion criteria for this review were: (1) migrant participants over 18 years old diagnosed with DM, as diabetes care for paediatric patients differs significantly from adult care due to developmental, physiological and psychosocial factors unique to children and adolescents (American Diabetes Association 2021) (2) studies focusing on dietary management or strategies aimed at improving diabetes management through dietary management, (3) studies conducted in PHC or community care settings where PHC practitioners provide care, (4) peer‐reviewed qualitative and quantitative studies, original research, systematic reviews, scoping reviews, (5) studies published in English, and (6) studies published between 2000 and 2024. This timeframe was chosen to capture research conducted within modern primary health care models, which developed after the transition from comprehensive to selective PHC approaches described by Cueto (2004). Limiting the review to studies published from 2000 onwards ensures relevance to current clinical and policy contexts.
+
+The exclusion criteria included (1) studies focusing on patients diagnosed with conditions other than DM Type 1 or Type 2, as gestational and other forms of diabetes involve distinct clinical pathways and dietary management approaches (Rasmussen et al. 2020), (2) studies that did not mention dietary management for diabetes management, (3) dietary management delivered outside of primary care settings, and (4) studies that did not include migrant populations as part of the sample.
+
+3.5 Search Outcome
+
+The selection process, illustrated in Figure 1, involved screening of 377 potential studies from across CINAHL (n = 146), PubMed (n = 103), and Scopus (n = 128). After removing 134 duplicate records and 24 records marked as ineligible by another deduplication automation tool, 219 studies were screened. Titles and abstracts were independently reviewed by three members of the research team, resulting in the exclusion of 159 studies based on irrelevance to the research question. The remaining 60 studies were sought for full‐text retrieval, and no studies were left unretrieved. Following the review of these 60 studies, 29 studies were excluded for the following reasons: 18 studies were excluded due to an ineligible context, 9 due to an ineligible phenomenon of interest, and 3 for failing to meet the eligibility criteria outlined in the PCC framework. As detailed in Figure 1, the selection process resulted in 30 studies meeting the inclusion criteria and included in the final review.
+
+FIGURE 1 PRISMA diagram.
+
+3.6 Quality Appraisal
+
+Although scoping reviews do not traditionally focus on appraising the quality of studies (Arksey and O'Malley 2005), literature has emphasised the importance of integrating a critical appraisal process to enhance the transparency and trustworthiness of a review (Levac et al. 2010). For this review, the JBI Critical Appraisal Tools were employed to assess the methodological quality of the qualitative, quantitative, and systematic review studies, while mixed‐methods studies were critically appraised using the Mixed Methods Appraisal Tool (MMAT). All studies scored 70% or higher on the quality indicators and were included in the review (See Tables B1, B2, B3, B4: Appendix B).
+
+3.7 Data Abstraction
+
+One researcher extracted and summarised data following the data extraction guide outlined with the JBI methodology guidelines (Pollock et al. 2023). The characteristics of the included studies, presented in Table B5, capture critical details from each study, including the author, year of publication, aim and study methods, participants, location and setting, results and key findings from the study. Two separate reviewers independently validated the extracted data to ensure the accuracy of the findings.
+
+3.8 Synthesis
+
+Thematic analysis was adopted to identify and summarise key findings from the studies (Naeem et al. 2023). Thematic analysis provides a flexible yet structured framework to synthesise and extract data that can be modified to suit different study designs and data types (Nowell et al. 2017). The studies in the review were systematically analysed by two researchers to minimise bias and ensure robustness of the analysis. Initially, the included studies were reviewed to extract similarities and patterns used to code into preliminary themes. Then, the researchers compared and discussed their codes until a consensus was reached on the themes. Ultimately, the thematic analysis of the studies revealed four key themes, including the impact of culture on diabetes management, culturally tailored management for diabetes management, communication in diabetes care, and access and availability of diabetes management among migrants.
+
+4 Results
+
+The general characteristics of the included studies are outlined in Table B5. Studies were conducted across various geographical regions, with the highest number originating from the United States (n = 9), followed by the United Kingdom (n = 4), Sweden (n = 4), Australia (n = 3), and Canada (n = 3). Other countries represented include Israel (n = 1), Ireland (n = 1), Italy (n = 1), and Finland (n = 1). The study designs encompassed qualitative (n = 18), quantitative (n = 5), mixed methods (n = 3), and systematic or scoping reviews (n = 5), which reflect a diversity of approaches to understanding dietary diabetes management among migrant populations. Most studies focused on culturally tailored management and communication strategies in diabetes care, while several others examined the influence of culture on diabetes self‐management practices and healthcare access within the context of dietary diabetes care. Methodological quality appraisal using the relevant JBI or MMAT tools (See Tables B1, B2, B3, B4: Appendix B) indicated that all studies were of moderate to high methodological rigour, with clear objectives, sound study designs, and appropriate recruitment and data collection processes. Common weaknesses varied by study designs, including limitations in cultural congruity and participant voice representation in some qualitative studies, gaps in baseline comparability and participant allocation clarity in some quantitative studies, and absence of risk‐of‐bias assessment in review studies. These quality considerations are referenced within each theme and considered in the interpretation of findings.
+
+An analysis of the included studies identified four key themes: the impact of culture on diabetes management practices, culturally tailored diabetes management, communication in diabetes care, and access to care for migrant populations. These themes reflect the key focus areas for improving dietary diabetes care delivery for migrant groups.
+
+4.1 Impact of Culture on Diabetes Management Practices
+
+The theme of cultural impact on diabetes management emerged as the overarching factor that influences dietary practices among migrant populations. This theme reflects the findings from 10 included studies (see Table B5) and highlights how cultural practices, values, and beliefs impact migrants' ability to adhere to clinical dietary recommendations and diabetes self‐management practices. Most of the studies contributing to this theme were qualitative (See Table B1: Appendix B) and demonstrated strong methodological rigour, with clear aims and robust designs and data collection. Some had gaps in cultural congruity (Q6) and representation of participants' voices (Q7), indicating that while cultural issues were explored, they were not always fully embedded in the research design. The mixed‐methods studies contributing to this theme (See Table B4: Appendix B) have met all critical appraisal criteria, strengthening the reliability of these findings.
+
+Mu'Min Chowdhury et al. (2000) examined how religious dietary laws and traditional food classification among British Bangladeshis influenced their food preferences, with a focus on halal foods and categorising foods by “strength” and “digestibility” rather than nutritional value. These culturally grounded preferences often led to food practices that are misaligned with clinical dietary guidelines for diabetes management (Mu'Min Chowdhury et al. 2000). For example, with this cultural food classification, plants growing from the ground are perceived as weak due to incomplete extraction of the earth's nourishing power, while red meat is regarded as stronger than other sources like poultry and fish. This classification is associated with low vegetable consumption and high red meat intake, which do not align with clinical dietary recommendations that prioritise vegetables, whole grains, and lean meats for managing diabetes (Kim et al. 2016).
+
+Similarly, Wan et al. (2023) highlighted that high‐carbohydrate dietary traditions and social stigma posed significant barriers to diabetes dietary adherence, while noting that participants valued culturally aligned support from health professionals of similar ethnic backgrounds. The findings by Dor‐On et al. (2022) also highlighted the cultural conflict faced by migrants in balancing traditional values with adherence to dietary guidelines for diabetes. The participants' collectivist values often led them to prioritise social obligations, such as accepting food offered by hosts, even when it conflicted with dietary management advice (Dor‐On et al. 2022).
+
+As identified by Roth et al. (2021), the impact of culture is evident in the experiences of Sudanese migrants in Australia, who struggled to adapt to dietary advice due to the significance of traditional carbohydrate‐rich foods that are central to their social gatherings. The collectivist nature of the participants, characterised by prioritising social obligations and communal values over individual needs, also led them to prioritise social expectations over dietary restrictions (Roth et al. 2021). Many participants relied on traditional remedies such as cinnamon tea, fenugreek seeds, mahogany bark, and Arabic gum to lower blood sugar levels, which can conflict with clinical recommendations (Roth et al. 2021).
+
+The impact of collectivism on diabetes management is reinforced by Leung et al. (2014), who found that participants are reluctant to disrupt cultural norms, such as sharing traditional high‐carbohydrate meals with family. The study also emphasised that participants showed a preference for group‐based diabetes education and valued shared experiences and peer interactions. A barrier identified by Leung et al. (2014) was the lack of culturally relevant diabetes information accessible to participants. The lack of culturally relevant health information, particularly dietary recommendations, negatively influenced participants' uptake of health advice (Leung et al. 2014).
+
+On the other hand, Ethiopian migrants, for example, viewed diabetes as “punishment” rather than a result of lifestyle choices and genetics, which complicates self‐management practices (Dor‐On et al. 2022). This study also highlighted that PHC nurses play a key role in addressing cultural and language gaps by facilitating peer models in group sessions and using professional liaisons fluent in the participants' native language to support the sessions. During group sessions, peer models who shared their successful diabetes management journeys acted as motivational figures for other participants, which reduced scepticism about clinical dietary recommendations (e.g., reduced sugar and fat intake) and feelings of social and cultural isolation (Dor‐On et al. 2022). Unlike other PHC professionals like GPs, who may only provide brief consultations, or dietitians who focus on specific dietary plans, PHC nurses are uniquely positioned to facilitate peer models through group education and utilise professional language liaisons to support the sessions. The participants reported that the professional liaisons provided clearer explanations than their family members (Dor‐On et al. 2022).
+
+The desire to avoid being burdensome was also evident in migrant cultural values, which influenced individuals' self‐management of diabetic practices (Leung et al. 2014). For example, Leung et al. (2014) found that Chinese immigrants displayed high regard for authority and upheld a passive patient role, which created barriers in communication between their health provider and limited their engagement in active self‐management. The participants perceived the role of doctors and nurses as responsible for treatment rather than patient education, which negatively impacted their capacity to ask their health providers for diabetes education and relied on friends and family for sources of diabetes management advice (Leung et al. 2014). The tendency to seek diabetes information through personal networks was also identified in the study conducted by Hyman et al. (2014). The study identified that migrants are more likely to engage with PHC nurses and community‐based services to obtain diabetes management guidance compared to hospital‐based care (Hyman et al. 2014). PHC nurses, especially those working in the community, were perceived as the main source of education and regular health monitoring among the participants (Hyman et al. 2014).
+
+Despite the challenges of implementing dietary modifications, Roth et al. (2021) found that primary care providers, including diabetes educators, were viewed as trusted sources for diabetes education, especially in the early phase of diagnosis. Likewise, the study conducted by Staff et al. (2017) highlighted the preference among migrants to receive culturally adapted care, with PHC nurses providing support and tailored education to address individual needs. However, the study found that migrants are less likely to participate in standard diabetes programmes than native‐born populations, yet culturally tailored interventions and management were explicitly requested by migrant patients (Staff et al. 2017).
+
+4.2 Culturally Tailored Management for Diabetes Management Among Migrants
+
+The theme of culturally tailored management emerged from studies highlighting the improved health outcomes associated with culturally adapted interventions. Of the 30 studies reviewed, 10 specifically examined culturally tailored management, emphasising its role in enhancing engagement, adherence, and health outcomes among migrant populations. The quantitative studies contributing to this theme (See Table B2: Appendix B) generally demonstrated high‐quality intervention design and clear outcome measurements. Some had weaknesses in participant allocation (Q2) and baseline comparability (Q4), while the reviews (See Table B3: Appendix B) provided a comprehensive synthesis of findings but lacked an explicit risk‐of‐bias assessment (Q9). The qualitative studies were predominantly high quality, with minimal gaps in cultural congruity.
+
+One example, Kim et al. (2009) found that a culturally tailored self‐help intervention for T2DM management, including a 6‐week psycho‐behavioural education programme by bilingual nurses and a nutritionist, home glucose monitoring with tele‐transmission, and 24 weeks of monthly bilingual nurse counselling, helped achieve HbA1c target levels and improved diabetes management skills. At 18 weeks, 10% of participants achieved their target HbA1c levels of less than 7%, which increased to 15.5% by 30 weeks after the intervention commenced (Kim et al. 2009). The participants also reported high satisfaction with the intervention, with a 95.2% retention rate, improved quality of life and reduced depressive symptoms (Kim et al. 2009). This is consistent with the findings in Choi and Rush (2012), which revealed that diabetes sessions delivered by a bilingual nurse and subsequent follow‐up resulted in significant improvements in HbA1c, HDL levels and other related biometrics (e.g., waist circumference) among migrant participants. Delivering sessions in the participants' native language and discussing dietary diabetes management using traditional Korean foods improved engagement and helped participants understand the application of dietary recommendations to their own cultural practices (Choi and Rush 2012). This reinforces that while dietitians may provide specific dietary plans, it is often nurses who ensure the translation of dietary advice into daily practice through continuous patient contact and integration of cultural identity into ongoing management. In a systematic review, Joo (2014) found similar improvements across Asian immigrant populations, linking culturally tailored diabetes programmes such as bilingual services and resources, community‐based delivery, family involvement, to improved clinical outcomes and patient satisfaction.
+
+Similarly, addressing the emotional and spiritual needs of Haitian migrants has been found to be vital to improving self‐management diabetic practices among this population (Magny‐Normilus et al. 2019). The participants expressed the need for healthcare providers, who understand their customs and food preferences, as a lack of cultural understanding affects their adherence to self‐management practices (Magny‐Normilus et al. 2019). A review conducted by Osokpo et al. (2021) identified that culturally tailored diabetes management, which is aligned with migrants' cultural practices, improves adherence to self‐care practices. Osokpo et al. (2021) detailed that migrants are more likely to engage with diabetes services that incorporate traditional remedies and uphold their cultural identity and beliefs. Gulyani et al. (2024) also identified that culturally appropriate diabetes management strategies and patient‐provider relationships serve as facilitators to optimal diabetes management. Migration‐related factors, such as language barriers and financial constraints, along with tradition‐based practices like communal eating, are significant barriers for South Asian migrants (Gulyani et al. 2024). These findings are consistent with the broader themes of integrating cultural considerations into dietary diabetes management for migrant populations.
+
+The study by Pettersson et al. (2023) affirmed that a culturally appropriate digital tool can promote diabetes self‐management in migrants. The tool is a digital platform designed to support self‐care in migrant patients with T2DM by providing accessible, multilingual educational resources and practical guidance on diabetes management (Pettersson et al. 2023). Pettersson et al. (2023) emphasised that integrating suitable language and considering cultural context when developing a digital tool is vital to improving self‐care adherence and diabetes control in the target population. This is congruent with the findings of Caselgrandi et al. (2016), who demonstrated that the delivery of diabetes care to Ghanian migrants, facilitated by a culturally competent Clinical Research Nurse (CRN), led to increased engagement with healthcare services among the Ghanian community in Italy. The CRN played both a supportive and advocacy role by acting as a liaison between participants and the healthcare team, while organising follow‐ups with participants to assess their perceptions of care and health outcomes (Caselgrandi et al. 2016). This advocacy role reflects a broader nursing function that is distinct from other PHC providers, where the nurse serves as a consistent patient advocate to achieve cultural preservation. The study by McEwen et al. (2010) examined the role of a bilingual and bicultural Certified Diabetes Educator (CDE) and a nurse researcher in developing a culturally tailored intervention for Mexican Americans with Type 2 diabetes living in the US‐Mexico border region. The CDE and nurse researcher collaboratively designed the six‐monthly group sessions and home visits, which were delivered by the CDE and trained promotoras (community health workers). Findings from the study indicated an increase in self‐management efficacy and a decrease in diabetes‐related distress and sedentary behaviours as a result of the culturally tailored interventions. Fleming and Gillibrand (2008) also emphasised the importance of personalising diabetes care and integrating complementary and biomedical management, urging nurses to consider individual interpretations of culture rather than broad stereotypes to address socio‐economic and contextual barriers to effective healthcare delivery.
+
+4.3 Communication in Diabetes Care for Migrant Populations
+
+The theme of communication barriers emerged from studies highlighting the critical role of language and culturally tailored communication in diabetes management. Of the thirty studies included, six focused specifically on communication barriers, examining the impact on patient‐provider relationships, self‐management, and access to effective diabetes care. These were primarily informed by qualitative studies (See Table B1: Appendix B) and a quantitative study, several of which met all critical appraisal criteria and demonstrated strong methodological rigour.
+
+Martin (2014) found that migrant patients often struggled to articulate their health concerns in their second language, leaving them feeling overwhelmed and misunderstood. In the study, providers were found to prioritise biomedical metrics (e.g., hbA1c, BSL) and disregarded the “lifeworld” concerns from patients (Martin 2014). For example, a patient emphasised the significance of honey in their diet but was dismissed by providers without meaningful engagement. Patterns of perspectives misalignment persisted over a five‐month period across consultations with different providers (Martin 2014). Similarly, Brämberg et al. (2012) found that the Diabetes Nurse Specialist (DNS) assumed a dominant role in patient interactions, characterised by one‐way communication and a reliance on medical care checklists. It was also observed that the DNS failed to respond to the patient's social context and concerns and merely provided care that was task‐focused (Brämberg et al. 2012). These findings highlight the role variation even within PHC nursing, underscoring the need for nurses to move beyond task‐based care and embrace their unique relational capacity, which differs from other PHC professionals.
+
+Another study by Rhodes and Nocon (2003) explored the use of informal interpreters like family members within a Bangladeshi community in the UK. While this practice facilitates basic communication, it often leads to miscommunication and misinterpretation of critical health information (Rhodes and Nocon 2003). Findings also indicated that the reliance on family members for communication fostered dependency and limited patients' ability to actively partake in the care planning and discussion (Rhodes and Nocon 2003).
+
+The impact of effective and culturally tailored communication is further evident in Rechenberg et al.'s (2021) study, which focused on implementing a language‐concordant health coaching for Latinx migrants who had diabetes. The program involved Spanish‐speaking nurse‐led bi‐weekly sessions to help participants set personal health goals, identify barriers, and develop confidence to achieve their goals. Participants received up to six bi‐weekly calls to discuss experiences and challenges related to self‐management, including dietary modifications, medication adherence, and exercise (Rechenberg et al. 2021). The results showed improvement in glycaemic control and emotional well‐being in the intervention group compared to the control group. This nurse‐led intervention illustrates how the nursing role differs from GPs in diabetes management in PHC, highlighting that nurses are essential for ongoing patient‐provider communication, motivational coaching, and culturally preserving monitoring.
+
+Alzubaidi et al. (2016) highlighted a similar need for culturally appropriate communication and ongoing support for Arabic‐speaking migrants. Alzubaidi et al. (2016) emphasised the value of a storytelling method, which involves discussing experiences and learning from shared narratives to help reinforce self‐management behaviours within a culturally familiar context. The participants reported that storytelling sessions felt more relevant to their cultural context and helped them address diabetes management barriers, particularly around dietary and lifestyle modifications. Alzubaidi et al. (2016) noted the lack of continuous support and communication from primary care providers beyond the initial diagnosis, leading to gaps in knowledge and impaired self‐management skills. Without regular clinical guidance, participants reported feelings of isolation, confusion, and overwhelm, which contributed to poor treatment adherence (Alzubaidi et al. 2016). Similarly, Choi et al. (2018) underscore the importance of culturally tailored communication in diabetes education for Chinese patients, where directive and prescriptive communication styles were preferred over participatory approaches. While Alzubaidi et al. (2016) demonstrated the effectiveness of storytelling to contextualise self‐management practices within cultural narratives, Choi et al. (2018) revealed that Chinese patients' cultural values of hierarchy and compliance often resulted in passive engagement during consultations. Both studies highlight that misaligned communication approaches can lead to confusion and disengagement among participants.
+
+4.4 Access and Availability of Diabetes Care for Migrants
+
+The theme of access and availability emerged from studies that examined structural, cultural, and personal barriers faced by migrants when engaging with diabetes services. Among the thirty studies, five specifically focused on how the structural, cultural, and personal barriers shape access and utilisation of diabetes care. This theme was informed by qualitative, review, and mixed‐methods studies. The qualitative studies (See Table B1: Appendix B) were generally robust, with some studies showing gaps in cultural congruity and participant voice representation, potentially limiting cultural contextualisation. The contributing mixed‐method studies met all criteria, offering strong integration of qualitative and quantitative perspectives.
+
+An example by Joo and Lee (2016) identified that cost, language barriers, and limited access to culturally appropriate diabetes services hinder diabetes management among Korean‐American older immigrants. These perceived barriers have been found to reduce their engagement and uptake of services, resulting in ineffective diabetes management and health outcomes (Joo and Lee 2016). The findings from Joo and Lee (2016) highlight that family and peer support significantly improve access and availability of diabetes care for migrant populations. Participants emphasised that family members assist with key diabetes‐related tasks, such as organising medical appointments and managing medications. For example, a female participant noted that her daughter's daily support was crucial in managing her diabetes, illustrating the importance of culturally familiar support networks in enhancing care access.
+
+The recurring themes of access and availability of diabetes care were also present in Berterö and Hjelm (2010), which highlighted systemic barriers to diabetes care such as delays in receiving care, communication issues, lack of support from healthcare providers, and economic challenges. The study also found that navigating an unfamiliar health system and differences in provider expectations create challenges for migrants, directly impacting their access to diabetes care. Similarly, Hadziabdic et al. (2020) noted that migrants with diabetes often faced challenges with accessing linguistically and culturally appropriate diabetes education. It was demonstrated that migrants have lower knowledge about their condition compared to native populations (Hadziabdic et al. 2020). Whilst the role of the multi‐disciplinary diabetes care team was emphasised in the study, findings indicated that many primary care clinics lack culturally appropriate resources and availability of interpreters for migrants (Hadziabdic et al. 2020). In such contexts, nurses become the point of continuity, supporting patients to navigate and access interpreters or community resources. This advocacy and navigation support role distinguishes nursing from other PHC practitioners.
+
+5 Discussion
+
+This scoping review examined how PHC professionals, particularly nurses, deliver dietary management for diabetes among migrant populations. The review provided a nuanced understanding of the facilitators and barriers that impact the effectiveness of dietary diabetes care among migrants, highlighting opportunities to address improved health outcomes. The analysis identified four key themes: cultural influences on diabetes management, culturally tailored interventions, communication barriers, and access to care. The themes underscore the complex interplay of cultural, social, and structural factors shaping diabetes outcomes in migrant communities and highlight the central role of culturally responsive nursing practice.
+
+Language barriers, limited health literacy, and unfamiliarity with healthcare systems significantly hinder migrants' engagement with diabetes services (Rasi 2020). PHC nurses are well positioned to bridge these gaps through bilingual communication, interpreter services, and culturally resonant strategies such as storytelling and group education (Leung et al. 2014; Hyman et al. 2014). These approaches not only enhance understanding but also foster trust and inclusivity, enabling patients to engage more actively in their care (Alzubaidi et al. 2016; Magny‐Normilus et al. 2019). Culturally relevant communication and education through group sessions and peer support programmes, led by PHC nurses, can strengthen social networks and provide emotional and behavioural support in culturally meaningful ways (Fisher et al. 2012; Kolomvotsou and Riza 2021; Tang et al. 2015). Storytelling and language‐concordant coaching further contextualise clinical advice, making it more relatable and actionable. These strategies empower patients and promote sustained behavioural change (Alzubaidi et al. 2016; Rechenberg et al. 2021).
+
+Integrating cultural food preferences into dietary guidance is another critical strategy. Dietitians often provide the technical framework, but PHC nurses have the opportunity to adapt these frameworks into practical and culturally responsive management during continuous patient interactions. Many migrants retain traditional diets high in carbohydrates or starches, which often conflict with Western dietary recommendations (Kindarara et al. 2017). When clinical advice disregards cultural practices, it can lead to dissonance, mistrust, and poor adherence (Cha et al. 2012; Chowdhury et al. 2000; Dor‐On et al. 2022; Wan et al. 2023). PHC nurses can address this by adapting dietary education to include culturally appropriate substitutions and modifications, preserving cultural identity while supporting health goals (Gulyani et al. 2024; Osokpo et al. 2021).
+
+Cultural beliefs also shape perceptions of illness and influence self‐management. For example, viewing diabetes as a form of punishment, as seen among Ethiopian migrants, may lead to reliance on traditional remedies over clinical advice (Dor‐On et al. 2022). These beliefs can hinder adherence to clinical dietary advice, as they drive reliance on traditional remedies that align more closely with cultural values but conflict with evidence‐based recommendations (Roth et al., 2021; Leung et al. 2014; Hjelm and Bard 2013). While traditional remedies serve as a means of preserving cultural identity, their misalignment with clinical guidelines can compromise glycaemic control and worsen health outcomes (Shewamene et al. 2021). PHC nurses can navigate these beliefs through respectful, patient‐centred dialogue, offering culturally acceptable alternatives and fostering therapeutic relationships that support self‐management (Saenz et al. 2024).
+
+As trusted providers, PHC nurses are uniquely positioned to deliver personalised, culturally responsive care, combining relational continuity with patients, accessibility and health education. Their regular patient interactions enable them to address cultural barriers, advocate for patient needs, and integrate traditional practices with evidence‐based care (Lukewich et al. 2022). High patient satisfaction with nurse‐led chronic disease management further supports this approach (Halcomb et al. 2015).
+
+To meet the diverse needs of migrant populations, PHC nurses must be equipped with cultural competency training. This includes understanding traditional health beliefs, communication styles, and dietary customs. Such training enhances care quality, builds trust, and improves patient engagement (Gulyani et al. 2024; Kaihlanen et al. 2020). Embedding cultural competency training into nursing education and professional development is essential for delivering inclusive, effective dietary interventions.
+
+Despite the insights gained, gaps remain in understanding how PHC nurses integrate cultural preservation with evidence‐based dietary management. Further research is needed to inform clinical practice and develop frameworks that support culturally tailored care in diverse migrant populations. While this review provides valuable insights into dietary management for migrants in PHC settings, several limitations must be acknowledged. First, the included studies often lacked reporting on participant demographics, particularly regarding cultural, socio‐economic, and educational diversity within migrant sub‐groups. This limits the ability to contextualise findings across different populations and highlights the need for more targeted research (Malmusi et al. 2010). Second, inconsistencies in how PHC roles were defined across studies reduce the generalisability of the findings. Finally, the exclusion of non‐English publications may have restricted the inclusion of perspectives from broader and more diverse populations, potentially introducing language bias.
+
+6 Conclusion
+
+This scoping review synthesised the current literature on dietary practices employed by PHC professionals, particularly nurses, in managing diabetes among migrant populations. Findings reveal key opportunities to strengthen PHC nursing practice by embedding cultural preservation into dietary care models, improving access to linguistically and culturally appropriate resources, and addressing systemic barriers that hinder culturally responsive care delivery. Key themes underscore the importance of cultural preservation and facilitating management that addresses the complexities of migrants' lived experiences, including linguistic, social, and systemic challenges. The findings highlight that PHC nurses should be supported through targeted cultural competency training, resource allocation, and policy collaboration to and deliver culturally preserving dietary care. National and global strategies must recognise the critical role of PHC nurses in diabetes management for migrants and provide adequate systemic support and resources to enable nurses to deliver inclusive care. This review calls for further research exploring intervention‐based studies that test culturally preserving dietary models in PHC settings, evaluating their impact on health outcomes and assessing applicability across diverse migrant populations and health systems.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Acknowledgements
+
+The authors would like to acknowledge Mrs. Jessica Elliot for her valuable assistance with editing and refining this manuscript. Open access publishing facilitated by University of Southern Queensland, as part of the Wiley ‐ University of Southern Queensland agreement via the Council of Australian University Librarians.
+
+Data Availability Statement
+
+The authors have nothing to report.
+
+Appendix A Search Strategy Table
+
+Key concept #1	Key concept #2	Key concept #3	Key concept #4	Date range	Limiters?	
+#9
+
+Nurses
+
+Nurse
+
+OR
+
+Nurses
+
+OR
+
+Nursing
+
+Not Used due to low results:
+
+“health profession*”
+
+OR
+
+“community health”
+
+	#10
+
+“Primary Health Care”[Mesh]
+
+“primary healthcare”
+
+OR
+
+“primary health care”
+
+OR
+
+“practice nurs*”
+
+OR
+
+“primary care”
+
+	#11
+
+“Diabetes Mellitus”[Mesh]
+
+Diabetes
+
+OR
+
+Diabetic*
+
+“diabetes management”
+
+OR
+
+“management of diabetes”
+
+Not Used due to low results:
+
+Management
+
+OR
+
+Diet*
+
+OR
+
+intervention
+
+	#12
+
+“Transients and Migrants”[Mesh] OR “Emigrants and Immigrants”[Mesh]
+
+Migrant*
+
+OR
+
+Immigrant*
+
+OR
+
+ESL
+
+OR
+
+“english as second language”
+
+	2000—present	Language: English
+
+Choose which types of resource will be included: Journal articles (peer‐reviewed)
+
+Books/chapters
+
+Theses
+
+Conference proceedings
+
+Government reports
+
+Organisational reports
+
+Business reports
+
+Newspaper articles
+
+	
+Abbreviations: PCC, population, concept, context; PICO, population, intervention/interest, context, outcome.
+
+CINAHL Search
+
+((MH Nurses+) OR (Nurse OR Nurses OR nursing OR “health profession*”)) AND ((MH “Diabetes Mellitus+”) OR (Diabetes OR Diabetic*)) AND ((MH “Migrants” OR MH “Immigrants+” OR MH “Emigration and Immigration+”) OR (Migrant* OR Immigrant* OR foreign* OR ESL OR “english as second language”)).
+
+PubMed Search
+
+(((“Nurses”[Mesh]) OR (Nurse[Text Word] OR Nurses[Text Word] OR nursing[Text Word] OR “health profession*”[Text Word])) AND ((“Diabetes Mellitus”[Mesh]) OR (Diabetes[Text Word] OR Diabetic*[Text Word]))) AND ((“Transients and Migrants”[Mesh] OR “Emigrants and Immigrants”[Mesh]) OR (Migrant*[Text Word] OR Immigrant*[Text Word] OR foreign*[Text Word] OR ESL[Text Word] OR “english as second language”[Text Word])).
+
+Scopus Search
+
+(((INDEXTERMS (nurses)) OR (TITLE‐ABS‐KEY (nurse) OR TITLE‐ABS‐KEY (nurses) OR TITLE‐ABS‐KEY (nursing) OR TITLE‐ABS‐KEY (“health profession*”))) AND ((INDEXTERMS (“Diabetes Mellitus”)) OR (TITLE‐ABS‐KEY (diabetes) OR TITLE‐ABS‐KEY (diabetic*)))) AND ((INDEXTERMS (“Transients and Migrants”) OR INDEXTERMS (“Emigrants and Immigrants”)) OR (TITLE‐ABS‐KEY (migrant*) OR TITLE‐ABS‐KEY (immigrant*) OR TITLE‐ABS‐KEY (foreign*) OR TITLE‐ABS‐KEY (esl) OR TITLE‐ABS‐KEY (“english as second language”))).
+
+Appendix B TABLE B1 Critical appraisal results for included studies using the JBI‐Qualitative Critical Appraisal Checklist.
+
+Study	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	
+Martin (2014)	Y	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Rhodes and Nocon (2003)	Y	Y	Y	Y	Y	U	N	Y	U	Y	
+Amirehsani (2010)	Y	Y	Y	Y	Y	U	N	N	NA	Y	
+Caselgrandi et al. (2016)	Y	Y	Y	Y	Y	U	Y	Y	Y	Y	
+Pettersson et al. (2023)	Y	Y	Y	Y	Y	U	Y	Y	Y	Y	
+Alzubaidi et al. (2016)	Y	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Mu'Min Chowdhury et al. (2000)	Y	Y	Y	Y	Y	Y	Y	Y	U	Y	
+Choi et al. (2018)	Y	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Dor‐On et al. (2022)	Y	Y	Y	Y	Y	N	U	Y	Y	Y	
+Nekouei Marvi Langari et al. (2024)	Y	Y	Y	Y	Y	N	Y	Y	Y	Y	
+Roth et al. (2021)	Y	Y	Y	Y	Y	N	N	Y	Y	Y	
+Leung et al. (2014)	Y	Y	Y	Y	Y	N	N	Y	Y	Y	
+Hjelm and Bard (2013)	Y	Y	Y	Y	Y	N	N	Y	Y	Y	
+Joo and Lee (2016)	Y	Y	Y	Y	Y	N	N	Y	Y	Y	
+Brämberg et al. (2012)	Y	Y	Y	Y	Y	N	N	Y	Y	Y	
+Choi et al. (2017)	Y	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Magny‐Normilus et al. (2019)	Y	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Abbreviations: N, no; NA, not applicable; U, unclear; Y, yes.
+
+TABLE B2 Critical appraisal results for included studies using the JBI Quasi‐experimental studies.
+
+Study	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	
+Hyman et al. (2014)	Y	Y	Y	Y	N	NA	Y	Y	Y	
+Choi and Rush (2012)	Y	N	Y	N	Y	Y	Y	Y	Y	
+Rechenberg et al. (2021)	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+Kim et al. (2009)	Y	Y	Y	Y	Y	Y	Y	Y	Y	
+McEwen et al. (2010)	Y	Y	Y	N	Y	Y	Y	Y	Y	
+Abbreviations: N, no; NA, not applicable; U, unclear; Y, yes.
+
+TABLE B3 Critical appraisal results for included studies using the JBI‐systematic reviews and research syntheses.
+
+Study	Q1	Q2	Q3	Q4	Q5	Q6	Q7	Q8	Q9	Q10	Q11	
+Gulyani et al. (2024)	Y	Y	Y	Y	Y	Y	Y	Y	N	Y	Y	
+Fleming and Gillibrand (2008)	Y	Y	Y	Y	Y	Y	Y	Y	N	Y	Y	
+Joo (2014)	Y	Y	Y	Y	Y	N	N	Y	N	Y	Y	
+Osokpo et al. (2021)	Y	Y	Y	Y	Y	Y	Y	Y	N	Y	Y	
+Hadziabdic et al. (2020)	Y	Y	Y	Y	Y	N	N	Y	N	Y	Y	
+Abbreviations: N, no; NA, not applicable; U, unclear; Y, yes.
+
+TABLE B4 Critical appraisal results for included studies using the Mixed Methods Appraisal Tool Version 2018.
+
+Study	Q1	Q2	Q3	Q4	Q5	
+Berterö and Hjelm (2010)	Y	Y	Y	Y	Y	
+Wan et al. (2023)
+
+	Y	Y	Y	Y	Y	
+Staff et al. (2017)	Y	Y	Y	Y	Y	
+Abbreviations: C, can't tell; N, no; Y, yes.
+
+TABLE B5 Data extraction table for Scoping Review.
+
+Author and title	Aim	Method	Participants	Setting	Results	Conclusion	
+Martin (2014)
+
+“Well I don't know what to say to that”: Exploring tensions between the voices of medicine and the lifeworld in the management of diabetes
+
+	Explore tensions between medical professionals and immigrant patient
+
+Focus on diabetes management and communication challenges
+
+	Qualitative
+
+Microanalysis of patient‐provider interactions
+
+Data collection over five months through several consultations with different providers
+
+	Single Case study on 42‐year‐old Egyptian female patient with poorly controlled Type 1 diabetes who interacts with nine healthcare providers	Ireland
+
+Diabetes clinic in an Irish hospital
+
+	Misalignment between patient's lifeworld and medical advice
+
+Communication barriers due to cultural and language differences
+
+Patient frustration due to lack of empathy and understanding
+
+	Cultural and linguistic differences hinder effective diabetes management
+
+Providers' limited engagement with patient's emotional and social context
+
+Need for improved cultural competence in healthcare
+
+	
+Hyman et al. (2014)
+
+Self‐management, health service use and information seeking for diabetes care among recent immigrants in Toronto
+
+	Explore self‐management practices, health service use, and information‐seeking behaviours among Black Caribbean immigrants with type 2 diabetes in Toronto	Quantitative
+
+Cross‐sectional study with structured questionnaires
+
+Participants: 48 Black Caribbean immigrants and 54 Canadian‐born individuals, aged 35–64
+
+Recruited from community health centres, diabetes education centres, hospitals, and immigrant‐serving organisations
+
+Focus on comparing diabetes self‐management and health service use between groups
+
+	48 Black Caribbean immigrants and 54 Canadian‐born participants
+
+Age range: 35–64 years
+
+	Canada
+
+Greater Toronto Area
+
+	Black Caribbean immigrants more likely to engage in recommended diabetes self‐management practices
+
+Higher use of community health centres and allied health professionals by Black Caribbean immigrants
+
+No significant differences in regular foot exams between groups
+
+	Community health centres play a crucial role in the favourable diabetes self‐management profile of Black Caribbean immigrants
+
+The need for further research to confirm these findings and explore the role of community health centres in other immigrant communities
+
+	
+Gulyani et al. (2024)
+
+Barriers and facilitators of lifestyle management among adult South Asian migrants living with chronic diseases: A mixed‐methods systematic review
+
+	Synthesise studies on barriers and facilitators of lifestyle management among South Asian migrants with chronic diseases	Mixed‐methods systematic review
+
+Data were thematically analysed using the Theoretical Domains Framework (TDF)
+
+	37 studies included, mostly from the UK, Canada, USA, and Norway
+
+Total of 1559 participants from South Asian countries (India, Pakistan, Bangladesh, etc.)
+
+	Studies conducted in primary care, community settings, and hospitals
+
+Studies done in numerous countries
+
+	Identified four overarching themes:
+
+1. Patient‐provider interaction and relationship
+
+2. Impact of migration
+
+3. Heritage‐based practices
+
+4. Chronic disease management strategies
+
+	Migration and cultural practices significantly influence chronic disease management
+
+Culturally tailored interventions are needed
+
+	
+Rhodes and Nocon (2003)
+
+A problem of communication? Diabetes care among Bangladeshi people in Bradford‌
+
+	Explore communication issues in diabetes care among Bangladeshi people in Bradford	Qualitative
+
+Study conducted in‐depth interviews with 12 Bangladeshi people
+
+Investigated the use of family members as informal interpreters during medical consultations
+
+Interviews were mostly conducted in Sylheti and analysed using a framework approach with the assistance of software
+
+	12 Bangladeshi participants aged between 43 and 75 years, including both men and women, who had been diagnosed with diabetes for varying lengths of time	United Kingdom
+
+Study took place in Bradford, UK, focusing on the Bangladeshi community within the city
+
+	Family members often helped with interpreting, but this sometimes led to poor care due to miscommunication and dependency	study suggests the need for better communication strategies and professional interpreting services to improve diabetes care	
+Amirehsani (2010)
+
+Mexican Americans With Type 2 Diabetes in an Emerging Latino Community: Evaluation of Health Disparity Factors and Interventions‌
+
+	Evaluate health disparity factors and interventions for Mexican Americans with type 2 diabetes in North Carolina	Qualitative
+
+Reviewed existing literature and interventions, focusing on culturally competent diabetes care
+
+	Mexican Americans with type 2 diabetes in North Carolina	USA
+
+Emerging Latino community in North Carolina
+
+	Culturally tailored interventions improve diabetes knowledge and control but need more research in emerging communities	Culturally competent care is essential for better diabetes outcomes in Mexican American communities	
+Fleming and Gillibrand (2008)
+
+An Exploration of Culture, Diabetes, and Nursing in the South Asian Community
+
+	Explore how culture influences diabetes self‐management in the South Asian community	Systematic review of qualitative studies
+
+Analysed 11 qualitative studies on South Asian culture and diabetes
+
+	South Asian individuals from India, Pakistan, Bangladesh, and Nepal
+
+Mixed religious backgrounds: Muslim, Hindu, Christian, Sikh
+
+	Studies mainly conducted in the United Kingdom, with one in India	Culture is dynamic and individualised, not a rigid framework
+
+South Asians negotiate cultural and contextual factors in diabetes self‐management
+
+	Culturally appropriate nursing care should be individualised	
+Caselgrandi et al. (2016)
+
+Clinical Research Nurse involvement to foster a community‐based transcultural research in RODAM European study
+
+	Explore and describe the involvement of a Clinical Research Nurse (CRN) in the Italian site of the RODAM study, focusing on transcultural nursing in the Ghanaian community	Qualitative
+
+CRN managed the project with a transcultural approach, collaborating with mediators, organising activities, and promoting healthcare among the Ghanaian community
+
+	Ghanaian migrants residing in Italy, involved in the RODAM study on obesity and type 2 diabetes	Italy
+
+Conducted within the Ghanaian community in Italy, utilising Ghanaian churches as key locations
+
+	CRN's involvement led to the empowerment of the Ghanaian community, improved healthcare awareness, and participation in the study	CRN's strategies, including a transcultural approach and community engagement, were crucial in achieving study success and fostering community empowerment	
+Choi and Rush (2012)
+
+Effect of a Short‐Duration, Culturally Tailored, Community‐Based Diabetes Self‐management Intervention for Korean Immigrants‌
+
+	Assess the effectiveness, feasibility, and acceptability of a short‐duration, culturally tailored diabetes self‐management program for Korean immigrants	Quantitative
+
+2‐session diabetes education program delivered by a bilingual nurse practitioner at a community centre, with follow‐up at 3 months
+
+	41 Korean immigrants with type 2 diabetes, aged 30–87	USA
+
+Korean community centre in a West Coast city
+
+	Significant improvements in A1C, HDL levels, waist circumference, and diabetes self‐care behaviours (e.g., feet checks)	culturally tailored approach in community settings can improve diabetes outcomes among Korean immigrants	
+Pettersson et al. (2023)
+
+Developing a Culturally Appropriate Tool to Support Self‐Care in Migrants with Type 2 Diabetes – A Co‐Design Study‌
+
+	Develop a culturally appropriate tool to support self‐care in migrants with type 2 diabetes	Qualitative
+
+Co‐design process with stakeholders, including patients, healthcare providers, and researchers, involving brainstorming and prototyping
+
+	14 migrant patients, 10 healthcare providers, 4 researchers	Sweden
+
+Primary healthcare centre in southeast, Sweden.
+
+	Developed a digital platform in Arabic and Swedish for diabetes self‐care, including text, videos, and links to resources	The co‐designed platform supports diabetes self‐care in Middle Eastern migrants, offering a culturally tailored approach	
+Alzubaidi et al. (2016)
+
+Time to question diabetes self‐management support for Arabic‐speaking migrants: exploring a new model of care
+
+	Explore a new model of diabetes self‐management support for Arabic‐speaking migrants	Qualitative
+
+Semi‐structured interviews and focus groups with Arabic‐speaking migrants; thematic analysis
+
+	60 Arabic‐speaking migrants with type 2 diabetes in Melbourne, Australia.	Australia
+
+Primary, secondary, and tertiary healthcare settings in Melbourne
+
+	No ongoing support beyond initial diagnosis; strong preference for face‐to‐face storytelling in gender‐specific groups	Urgent need for culturally tailored, story‐based self‐management support for Arabic‐speaking migrants	
+Rechenberg et al. (2021)
+
+Feasibility and Acceptability of a Language‐Concordant Health Coaching Intervention Delivered by Nurses for Latinx with Type 2 Diabetes
+
+	Test the feasibility and acceptability of language‐concordant health coaching for Latinx immigrants with type 2 diabetes	Quantitative
+
+Pilot study; random assignment to control or intervention group. Intervention group received six bi‐weekly coaching sessions in Spanish
+
+	17 Latinx immigrants with type 2 diabetes and limited English proficiency	USA
+
+Federally qualified health centres
+
+	Significant reduction in A1c, depression, and anxiety symptoms in the intervention group	Language‐concordant health coaching is feasible, acceptable, and may improve key diabetes outcomes in Latinx populations	
+Mu'Min Chowdhury et al. (2000)
+
+Food beliefs and practices among British Bangladeshis with diabetes: Implications for health education
+
+	Understand food beliefs and practices among British Bangladeshis with diabetes	Qualitative
+
+Unstructured narrative interviews, pile sorting of food items, and participant observation
+
+	40 first‐generation adult immigrants from Sylhet, Bangladesh, with diabetes
+
+Equal gender mix, aged 24–78
+
+	United Kingdom
+
+Inner‐city areas of Tower Hamlets, Newham, and Islington in London, UK
+
+	Strong religious and cultural food practices, resistance to dietary changes
+
+Food classified as “strong/weak” and “digestible/indigestible,” not by Western nutritional standards
+
+	Health education should respect religious and cultural food practices
+
+Tailored advice considering cultural meanings can improve dietary management
+
+	
+Choi et al. (2018)
+
+Diabetes management in a foreign land: A case study on Chinese Australians
+
+	Understand the experience of Chinese migrants living with type 2 diabetes in Australia
+
+Explore their culturally specific diabetes management needs and expectations
+
+	Qualitative
+
+Case study approach using participant‐observations and qualitative interviews across Melbourne and Sydney
+
+Thematic analysis with pattern matching was used for data analysis
+
+	18 participant‐observations and 12 interviews
+
+Participants included Chinese migrants with diabetes and health professionals
+
+	Diabetes education sessions and clinical sites in Melbourne and Sydney, Australia	Barriers to accessing Australian diabetes care due to language and cultural differences
+
+Chinese patients relied heavily on peer networks rather than health professionals for diabetes management
+
+Diabetes services often mismatched Chinese cultural expectations
+
+	Redesigning diabetes care services to align with collectivist principles may better support Chinese migrants in managing diabetes effectively	
+Dor‐On et al. (2022)
+
+Ethiopian immigrants with diabetes in Israel: Oscillating between two narratives
+
+	Examine the role of cultural differences in managing diabetes among Ethiopian immigrants living in Israel	Qualitative
+
+Semi‐structured interviews
+
+Thematic analysis focusing on participants' cultural and personal narratives regarding diabetes
+
+	16 Ethiopian immigrants with type 1 or 2 diabetes, living in Israel
+
+Mean age was 52.4 years, with a nearly equal gender split.
+
+	Israel
+
+Conducted at three Clalit Health Services general medicine clinics
+
+	Participants oscillated between familiar (Ethiopian) and foreign (Israeli) narratives in understanding and managing diabetes
+
+Challenges included conflicting views on the causes of diabetes, food practices, and trust in medical treatment versus traditional beliefs
+
+	Ethiopian immigrants in Israel face internal conflicts between traditional and modern perspectives on diabetes management
+
+Culturally competent care and involving community liaisons can improve diabetes management in this population
+
+	
+Joo (2014)
+
+Effectiveness of Culturally Tailored Diabetes Interventions for Asian Immigrants to the United States
+
+	Evaluate the effectiveness of culturally tailored diabetes interventions for Asian immigrants in the U.S.	Systematic review of 9 studies on culturally tailored diabetes programs for Asian immigrants	Asian immigrants with type 2 diabetes in the U.S.	USA
+
+Community‐based settings in the U.S., including California, Hawaii, New York, and Maryland
+
+	Culturally tailored programs improved clinical outcomes (e.g., A1C levels) and psycho‐behavioural outcomes, with high patient satisfaction	Culturally tailored diabetes interventions are effective for Asian immigrants, but more rigorous studies are needed to confirm these findings	
+Osokpo et al. (2021)
+
+Maintaining cultural identity: A systematic mixed studies review of cultural influences on the self‐care of African immigrants living with non‐communicable disease‌
+
+	Identify cultural factors influencing self‐care among African immigrants with chronic illnesses	Systematic mixed studies review of nine studies on African immigrants' self‐care practices	African immigrants with non‐communicable diseases living outside Africa	Studies conducted in the U.S., Australia, Sweden, the Netherlands, and the UK	Cultural norms, non‐Western illness interpretations, and structural challenges influence self‐care. Family support aids self‐care but cultural identity can both help and hinder it	Cultural and structural factors shape self‐care behaviours in African immigrants. Integrating cultural considerations into healthcare is essential for improving self‐care	
+Nekouei MarvLangari et al. (2024)
+
+Registered nurses' perceptions of healthy lifestyle counselling for immigrants in primary healthcare: A focus group study‌
+
+	Explore registered nurses' perceptions of healthy lifestyle counselling for immigrants to prevent chronic diseases	Qualitative
+
+Focus group interviews with 23 registered nurses
+
+	23 registered nurses working in primary healthcare across four Finnish municipalities	Finland
+
+Primary healthcare settings in Finland (Espoo, Vantaa, Lappeenranta, Joensuu)
+
+	Participant perceptions were related to uniform counselling practices, challenges in counselling immigrants, the need for culturally tailored services and utilising insights from practical experience to improve the counselling service
+
+	Culturally sensitive health promotion services are essential to improve immigrant health outcomes	
+Kim et al. (2009)
+
+A community‐based, culturally tailored behavioural intervention for Korean‐Americans with Type 2 diabetes
+
+	Test the efficacy of a culturally tailored diabetes management intervention for Korean‐American immigrants (KAIs)	Quantitative
+
+Randomised controlled trial with 79 KAIs, involving a 6‐week education program, home glucose monitoring, and bilingual nurse counselling
+
+	79 Korean‐American immigrants with uncontrolled type 2 diabetes in the Baltimore‐Washington area	USA
+
+Community‐based settings in the Baltimore‐Washington area
+
+	Significant reduction in hbA1C levels and improvements in psychosocial outcomes for the intervention group	The culturally tailored intervention effectively improved glucose control and diabetes management skills among KAIs	
+Roth et al. (2021)
+
+Knowledge and perceptions around self‐management of type 2 diabetes among a Sudanese community in Australia: a qualitative study
+
+	Explore the perceptions and experiences of diabetes self‐management among Sudanese migrants in Australia	Qualitative
+
+Qualitative study with semi‐structured in‐depth interviews of 12 Sudanese participants in Melbourne, Australia
+
+	12 Sudanese immigrants living with type 2 diabetes, who were recruited at GP clinics, community centres	Australia
+
+Interviews conducted in mutually agreed public location in Melbourne, Australia
+
+	Barriers: Language differences, burden of self‐management, traditional dietary practices, and social obligations
+
+Enablers: Positive relationships with health professionals, support networks, religion, and traditional remedies
+
+	Cultural factors, including traditional practices and familial obligations, significantly influence diabetes management in the Sudanese community. Culturally appropriate health services are needed	
+Berterö and Hjelm (2010)
+
+Social support as described by foreign‐born persons diagnosed with type 2 diabetes mellitus and living in Sweden‌
+
+	Explore and describe the meaning of social support and its impact on the life situation of foreign‐born persons with type 2 diabetes in Sweden	Mixed‐methods study using semi‐structured interviews and the Norbeck Social Support Questionnaire (NSSQ)	34 foreign‐born adults with type 2 diabetes, aged 36–73 years
+
+Predominantly from the Middle East and former Yugoslavia
+
+	Sweden
+
+Conducted at a hospital‐based diabetes clinic and primary healthcare centres
+
+	Social support was perceived as limited, particularly around the time of diagnosis
+
+Support needs varied by gender, age, and disease severity
+
+Women valued emotional support, while men emphasised informational support
+
+	There is a need for culturally sensitive, specialised diabetes care that provides consistent support from the time of diagnosis	
+Wan et al. (2023)
+
+Dietary management of type 2 diabetes mellitus among South Asian immigrants: A mixed‐methods study
+
+	Investigate dietary patterns and explore barriers and facilitators to dietary management among South Asian immigrants with type 2 diabetes in Australia	Mixed‐methods study with three 24‐h dietary recalls and semi‐structured interviews
+
+Data analysed using SPSS for quantitative and NVivo for qualitative analysis
+
+	18 self‐identified South Asian immigrants with type 2 diabetes
+
+Participants were recruited from Victorian primary care clinics and social media
+
+	Australia
+
+Conducted across primary care clinics and social media platforms in Victoria, Australia
+
+	Participants had lower intake of grains, fruits, and dairy than Australian dietary recommendations
+
+Reported difficulties in adapting dietary advice into their routines and lacked knowledge of available support
+
+Relied more on health professionals than on family or friends for support
+
+	Improving access to organisational support and adapting dietary recommendations into daily routines are essential for better diabetes management among South Asian immigrants	
+Leung et al. (2014)
+
+Health literacy issues in the care of Chinese American immigrants with diabetes: a qualitative study
+
+	Investigate why Chinese American immigrants with diabetes struggle with health literacy despite available resources	Qualitative
+
+Focus groups and interviews with thematic analysis.
+
+	29 first‐generation Chinese immigrants with type 2 diabetes, aged ≥ 45	USA
+
+Community health centres and a retirement village in Los Angeles, California
+
+	Identified cultural, structural, and personal barriers affecting health literacy, such as respect for authority, reluctance to burden others, and lack of health insurance	Health literacy issues in Chinese immigrants require culturally sensitive approaches that address specific cultural norms and barriers	
+Hadziabdic et al. (2020)
+
+Development of a group‐based diabetes education model for migrants with type 2 diabetes, living in Sweden
+
+	Develop a culturally appropriate diabetes education model for migrants with type 2 diabetes in Sweden	Literature review, previous studies, and collaboration with a multi‐professional diabetes team to create a focus group‐based education model	Migrants with type 2 diabetes living in Sweden	Sweden
+
+Primary healthcare centres
+
+	A five‐session, group‐based education model focusing on individual beliefs about health and illness, facilitated by a diabetes specialist nurse with support from a multi‐professional team	The model is tailored to individual and cultural needs, aiming to improve diabetes knowledge and self‐care among migrants	
+McEwen et al. (2010)
+
+Type 2 Diabetes Self‐Management Social Support Intervention at the U.S.‐Mexico Border
+
+	Test the efficacy of a culturally tailored diabetes self‐management social support intervention for Mexican American adults	Quantitative
+
+Single‐group pre‐test and post‐test design
+
+A bilingual CDE and Nurse Researcher developed a culturally tailored diabetes self‐management social support intervention
+
+Six‐monthly group sessions and three home visits were conducted by community health workers, in collaboration with a Certified Diabetes Educator
+
+	21 Mexican American adults with type 2 diabetes	U.S.‐Mexico border region
+
+Arizona‐Sonora
+
+	Improved self‐management activities, diabetes knowledge, and reduced distress; no significant changes in HbA1c or BMI	Community health workers successfully delivered a culturally tailored intervention that improved self‐management behaviours, though physiological outcomes remained unchanged	
+Hjelm and Bard (2013)
+
+Beliefs About Health and Illness in Latin‐American Migrants with Diabetes Living in Sweden
+
+	Explore health and illness beliefs in Latin‐American migrants with diabetes in Sweden and their impact on self‐care and care‐seeking behaviour	Qualitative
+
+Qualitative exploratory study with focus group interviews
+
+	Nine Latin‐American migrants with diabetes, aged 36–77, living in Sweden	Sweden
+
+Focus groups held in secluded rooms, with participants recruited from a diabetes clinic
+
+	Health seen as freedom from disease and well‐being; reliance on both biomedical and traditional remedies; economic hardship impacts health; active self‐care with limited reliance on healthcare professionals	Culturally tailored care is essential, incorporating discussions of alternative treatments and addressing financial and migrational challenges	
+Joo and Lee (2016)
+
+Barriers to and facilitators of diabetes self‐management with elderly Korean‐American immigrants
+
+	Explore the barriers and facilitators of diabetes self‐management among elderly first‐generation Korean‐American immigrants with type 2 diabetes in the Midwest, USA	Qualitative
+
+Qualitative descriptive design using three focus groups (N = 18) and five individual interviews
+
+Data were recorded, transcribed, translated, and analysed using content‐based analysis
+
+	23 first‐generation Korean‐American elderly immigrants aged 65 years or older with type 2 diabetes for at least one year, living in the Midwest	Midwest
+
+Korean community in the Midwest
+
+	Barriers: high costs, language issues, memory loss.
+
+Facilitators: family support, time, seeking information.
+
+	Addressing barriers and enhancing facilitators can improve diabetes management for elderly Korean‐Americans	
+Brämberg et al. (2012)
+
+Lack of individualised perspective: A qualitative study of diabetes care for immigrants in Sweden
+
+	To describe the care provided by a diabetes nurse specialist (DNS) and the care needs expressed by immigrants with type 2 diabetes mellitus (T2DM)	Qualitative
+
+Qualitative, exploratory design using observations of clinical encounters between a DNS and 10 immigrant patients with T2DM.
+
+Data were analysed using qualitative content analysis
+
+	10 immigrants with T2DM (6 women and 4 men), originally from the Middle East, visiting the DNS at a community health centre in Sweden	Sweden
+
+A community health centre in western Sweden, serving about 7000 people, 10% of whom were foreign‐born
+
+	The study found a power imbalance in clinical encounters
+
+The DNS controlled the structure and content of the visits, limiting patient involvement. Conversations focused on medical aspects, with little attention to individual experiences or social and practical matters
+
+	The care provided by the DNS was primarily technique‐centred, lacking individualised care
+
+The study suggests shifting towards a more patient‐centred approach to improve self‐management and adherence to diabetes care
+
+	
+Choi et al. (2018)
+
+Optimising the effectiveness of diabetes education in an East Asian population
+
+	To explore learning behaviours of Chinese people during diabetes education and suggest tailored strategies	Qualitative
+
+Case study using observations and interviews across Australia, China, and Singapore. Data analysed using thematic analysis
+
+	39 observations and 22 interviews with health professionals and Chinese individuals with diabetes	Australia, China, and Singapore
+
+Diabetes education sessions in hospitals and community centres across three countries
+
+	Chinese participants preferred clear, prescriptive instructions, were passive learners, and sought detailed facts. Trust‐building over time facilitated behaviour change	Diabetes education should be culturally adapted with clear instructions and rapport‐building to encourage behaviour change	
+Staff et al. (2017)
+
+Patients requests and needs for culturally and individually adapted supportive care in type 2 diabetes patients
+
+	To compare metabolic control and supportive care requests between Nordic and non‐Nordic type 2 diabetes patients	Mixed Methods
+
+Comparative study with 184 patients attending routine check‐ups
+
+Data collected from medical records and structured interviews
+
+	151 Nordic and 33 non‐Nordic type 2 diabetes patients in a socioeconomically vulnerable area of Linköping, Sweden	Linköping, Sweden
+
+Primary healthcare centre
+
+	Non‐Nordic patients had poorer metabolic control and requested more supportive care, especially more frequent contact with nurses and help with dietary habits
+
+Fewer non‐Nordic participants (60.6%) achieved the HbA1c target compared to Nordic participants (80.1%), with a significant difference (p = 0.016)
+
+	Culturally and individually adapted care is not only medically necessary but also requested by non‐Nordic patients	
+Magny‐Normilus et al. (2019)
+
+Self‐Management of Type 2 Diabetes in Adult Haitian Immigrants: A Qualitative Study
+
+	Explore the lived experiences of adult Haitian immigrants managing type 2 diabetes in the U.S.	Qualitative
+
+Phenomenological study with individual interviews and thematic analysis
+
+	16 Haitian immigrants with type 2 diabetes, aged 40–63, living in the U.S. for an average of 11 years	USA
+
+Urban outpatient clinic in the northeastern U.S.
+
+	Four themes: self‐reliance, spirituality, nostalgia for Haiti, and desire for better patient‐provider relationships	Culturally tailored care and improved communication with healthcare providers are needed to support diabetes self‐management in Haitian immigrants	
+
+
+References
+
+Abouzeid, M. , B. Philpot , E. D. Janus , M. J. Coates , and J. A. Dunbar . 2013. “Type 2 Diabetes Prevalence Varies by Socio‐Economic Status Within and Between Migrant Groups: Analysis and Implications for Australia.” BMC Public Health 13, no. 1: 1–9. 10.1186/1471-2458-13-252.23517376 PMC3620546
+Alshammari, M. , R. Windle , D. Bowskill , and G. Adams . 2021. “The Role of Nurses in Diabetes Care: A Qualitative Study.” Open Journal of Nursing 11, no. 8: 682–695. 10.4236/ojn.2021.118058.
+Alzubaidi, H. , K. Mc Namara , and C. Browning . 2016. “Time to Question Diabetes Self‐Management Support for Arabic‐Speaking Migrants: Exploring a New Model of Care.” Diabetic Medicine 34, no. 3: 348–355. 10.1111/dme.13286.27864988
+American Diabetes Association . 2021. “Children and Adolescents: Standards of Medical Care in Diabetes‐2021.” Diabetes Care 44, no. 1: 180–199. 10.2337/dc21-s013.33298424
+Amirehsani, K. A. 2010. “Mexican Americans With Type 2 Diabetes in an Emerging Latino Community: Evaluation of Health Disparity Factors and Interventions.” Home Health Care Management and Practice 22, no. 7: 470–478. 10.1177/1084822310368658.
+Arksey, H. , and L. O'Malley . 2005. “Scoping Studies: Towards a Methodological Framework.” International Journal of Social Research Methodology 8: 19–32. 10.1080/1364557032000119616.
+Australian Institute of Health and Welfare . 2024. “Diabetes: Australian Facts.” https://www.aihw.gov.au/reports/diabetes/diabetes/contents/summary.
+Berterö, C. , and K. Hjelm . 2010. “Social Support as Described by Foreign‐Born Persons Diagnosed With Type 2 Diabetes Mellitus and Living in Sweden.” Nursing and Health Sciences 12, no. 4: 507–514. 10.1111/j.1442-2018.2010.00569.x.21210931
+Brämberg, E. B. , E. Dahlborg‐Lyckhage , and S. Määttä . 2012. “Lack of Individualized Perspective: A Qualitative Study of Diabetes Care for Immigrants in Sweden.” Nursing and Health Sciences 14, no. 2: 244–249. 10.1111/j.1442-2018.2012.00684.x.22490066
+Caselgrandi, A. , G. Guaraldi , K. Cottafavi , G. Artioli , and P. Ferri . 2016. “Clinical Research Nurse Involvement to Foster a Community Based Transcultural Research in RODAM European Study.” Acta Bio Medica Atenei Parmensis 87, no. 2: 80–87.27240036
+Cha, E. S. , K. Yang , J. Lee , et al. 2012. “Understanding Cultural Issues in Diabetes Self‐Management Behaviors of Korean Immigrants.” Diabetes Educator 38, no. 6: 835–844. 10.1177/0145721712460283.23019236 PMC3753096
+Choi, S. E. , and E. B. Rush . 2012. “Effect of a Short‐Duration, Culturally Tailored, Community‐Based Diabetes Self‐Management Intervention for Korean Immigrants.” Diabetes Educator 38, no. 3: 377–385. 10.1177/0145721712443292.22491398 PMC3767570
+Choi, T. S. T. , K. Z. Walker , and C. Palermo . 2018. “Diabetes Management in a Foreign Land: A Case Study on Chinese Australians.” Health and Social Care in the Community 26, no. 2: 225–232. 10.1111/hsc.12501.28929540
+Chowdhury, A. M. M. , C. Helman , and T. Greenhalgh . 2000. “Food Beliefs and Practices Among British Bangladeshis With Diabetes: Implications for Health Education.” Anthropology and Medicine 7, no. 2: 209–226. 10.1080/713650589.
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+Kim, M. T. , H.‐R. Han , H.‐J. Song , et al. 2009. “A Community‐Based, Culturally Tailored Behavioral Intervention for Korean Americans With Type 2 Diabetes.” Diabetes Educator 35, no. 6: 986–994. 10.1177/0145721709345774.19934458 PMC2864500
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+Kindarara, D. M. , M. M. McEwen , J. D. Crist , and L. J. Loescher . 2017. “Health‐Illness Transition Experiences With Type 2 Diabetes Self‐Management of Sub‐Saharan African Immigrants in the United States.” Diabetes Educator 43, no. 5: 506–518. 10.1177/0145721717724725.28799453
+Kohinor, M. J. E. , K. Stronks , M. Nicolaou , and J. A. Haafkens . 2011. “Considerations Affecting Dietary Behaviour of Immigrants With Type 2 Diabetes: A Qualitative Study Among Surinamese in The Netherlands.” Ethnicity and Health 16, no. 3: 245–258. 10.1080/13557858.2011.563557.21516555
+Kolomvotsou, A. I. , and E. Riza . 2021. “Management of Diabetes Mellitus in Refugee and Migrant Patients in a Primary Healthcare Setting in Greece: A Pilot Intervention.” Epidemiologia 2, no. 1: 14–26. 10.3390/epidemiologia2010002.36417186 PMC9620876
+Leung, A. Y. M. , A. Bo , H.‐Y. Hsiao , S. S. Wang , and I. Chi . 2014. “Health Literacy Issues in the Care of Chinese American Immigrants With Diabetes: A Qualitative Study.” BMJ Open 4, no. 11: e005294. 10.1136/bmjopen-2014-005294.PMC4244415 25406155
+Levac, D. , H. Colquhoun , and K. K. O'Brien . 2010. “Scoping Studies: Advancing the Methodology.” Implementation Science 5, no. 1: 69. 10.1186/1748-5908-5-69.20854677 PMC2954944
+Li‐Geng, T. , J. Kilham , and K. M. McLeod . 2020. “Cultural Influences on Dietary Self‐Management of Type 2 Diabetes in East Asian Americans: A Mixed‐Methods Systematic Review.” Health Equity 4, no. 1: 31–42. 10.1089/heq.2019.0087.32195450 PMC7081245
+Lukewich, J. , R. Martin‐Misener , A. A. Norful , et al. 2022. “Effectiveness of Registered Nurses on Patient Outcomes in Primary Care: A Systematic Review.” BMC Health Services Research 22: 740.35659215 10.1186/s12913-022-07866-x PMC9166606
+Magny‐Normilus, C. , B. Mawn , and J. Dalton . 2019. “Self‐Management of Type 2 Diabetes in Adult Haitian Immigrants: A Qualitative Study.” Journal of Transcultural Nursing 31, no. 1: 51–58. 10.1177/1043659619841586.30957666 PMC7648446
+Malmusi, D. , C. Borrell , and J. Benach . 2010. “Migration‐Related Health Inequalities: Showing the Complex Interactions Between Gender, Social Class and Place of Origin.” Social Science and Medicine 71, no. 9: 1610–1619. 10.1016/j.socscimed.2010.07.043.20869798
+Martin, G. 2014. ““Well I Don't Know What to Say to That”: Exploring Tensions Between the Voices of Medicine and the Lifeworld in the Management of Diabetes.” European Journal of Applied Linguistics 2, no. 2: 204–232. 10.1515/eujal-2014-0008.
+McEwen, M. , A. Pasvogel , G. Gallegos , and L. Barrera . 2010. “Type 2 Diabetes Self‐Management Social Support Intervention at the U.S.‐Mexico Border.” Public Health Nursing 27, no. 4: 310–319. 10.1111/j.1525-1446.2010.00860.x.20626831 PMC2917267
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Health Serv Res
+Journal ID: BMC Health Serv Res
+NLM Journal ID: 101088677
+
+BMC Health Services Research
+
+EISSN: 1472-6963
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC10675888
+PMID: 38001460
+DOI: 10.1186/s12913-023-10022-8
+Article ID: 10022
+Article version: 1
+Subjects: Research
+
+A resilience view on health system resilience: a scoping review of empirical studies and reviews
+
+http://orcid.org/0000-0002-6946-7165 Copeland Samantha 1
+http://orcid.org/0000-0001-9043-8847 Hinrichs-Krapels Saba s.hinrichs@tudelft.nl
+1
+Fecondo Federica 1
+Santizo Esteban Ralon 1
+http://orcid.org/0000-0001-7202-5053 Bal Roland 2
+http://orcid.org/0000-0002-8721-8314 Comes Tina 1
+1 https://ror.org/02e2c7k09 grid.5292.c 0000 0001 2097 4740 Faculty of Technology, Policy and Management, Delft University of Technology, Jaffalaan 5, 2628 BX Delft, The Netherlands
+2 https://ror.org/057w15z03 grid.6906.9 0000 0000 9262 1349 Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Burg. Oudlaan 50, Rotterdam, The Netherlands
+Electronic publication date: 2023 Nov 24
+Publication date: 2023
+Volume: 23
+Electronic Location ID: 1297
+Received 2023 Jan 31; Accepted 2023 Sep 11
+Copyright: © The Author(s) 2023
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Resilience, Health systems, Resilience engineering, Socio-ecological resilience, Community resilience
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2023
+
+Ÿ==============================Ÿ
+Background
+
+Prompted by recent shocks and stresses to health systems globally, various studies have emerged on health system resilience. Our aim is to describe how health system resilience is operationalised within empirical studies and previous reviews. We compare these to the core conceptualisations and characteristics of resilience in a broader set of domains (specifically, engineering, socio-ecological, organisational and community resilience concepts), and trace the different schools, concepts and applications of resilience across the health literature.
+
+Methods
+
+We searched the Pubmed database for concepts related to ‘resilience’ and ‘health systems’. Two separate analyses were conducted for included studies: a total of n = 87 empirical studies on health system resilience were characterised according to part of health systems covered, type of threat, resilience phase, resilience paradigm, and approaches to building resilience; and a total of n = 30 reviews received full-text review and characterised according to type of review, resilience concepts identified in the review, and theoretical framework or underlying resilience conceptualisation.
+
+Results
+
+The intersection of health and resilience clearly has gained importance in the academic discourse with most papers published since 2018 in a variety of journals and in response to external threats, or in reference to more frequent hospital crisis management. Most studies focus on either resilience of health systems generally (and thereby responding to an external shock or stress), or on resilience within hospitals (and thereby to regular shocks and operations). Less attention has been given to community-based and primary care, whether formal or informal. While most publications do not make the research paradigm explicit, ‘resilience engineering’ is the most prominent one, followed by ‘community resilience’ and ‘organisational resilience’. The social-ecological systems roots of resilience find the least application, confirming our findings of the limited application of the concept of transformation in the health resilience literature.
+
+Conclusions
+
+Our review shows that the field is fragmented, especially in the use of resilience paradigms and approaches from non-health resilience domains, and the health system settings in which these are used. This fragmentation and siloed approach can be problematic given the connections within and between the complex and adaptive health systems, ranging from community actors to local, regional, or national public health organisations to secondary care. Without a comprehensive definition and framework that captures these interdependencies, operationalising, measuring and improving resilience remains challenging.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12913-023-10022-8.
+
+Introduction
+
+Background and context to this review
+
+The past 10 years have challenged health systems globally with several public health emergencies (COVID-19, SARS, Ebola Virus Disease), environmental disasters (flooding, hurricanes and earthquakes), as well as war and conflict shocks. Although health providers often deal with crises, these large-scale emergencies have revealed a need to deal with unprecedented care demand and shortages of staff, supplies and infrastructure. Beyond the direct effects and disruptions of each crisis, there are cascading effects such as delays in routine and non-emergency care. When these crises start to spread across political borders, there are governance, financial and cultural barriers that affect the ability to provide care equitably to all those in need.
+
+These sudden shocks and disruptions have prompted policymakers, practitioners, and scholars to learn how to increase the resilience of health systems. In recent research, perhaps prompted by COVID-19, there is has been a surge of interest in the concept of resilience, and many reviews have already been conducted on this topic, exploring the presence of resilience in empirical studies, or whether we can learn from the concepts of resilience generally to improve health system performance. For example, Biddle et al. 2020 provide a narrative review of resilience concepts in empirical studies, but provide little in-depth characterisation of resilience characteristics and their relevant capacities, or their applications across different health systems, which could provide useful learning on how to operationalise resilience in different health system contexts [1]. As Forsgren et al. (2022, this issue) suggest, this focus on the theoretical has led to a lack of knowledge about which strategies for building resilience have been successful, a gap they seek to close [2]. Similarly, Khalil et al. (2022) point out the need to operationalise resilience concepts into healthcare practice [3]. However, what is missing is a thorough analysis of what resilience paradigms and concepts outside of the health domain can offer health systems research and practice. Wiig and O’Hara offer a particularly useful starting point with their analysis of the impact that resilience engineering concepts are having on health systems research [4]. Our aim here is to augment existing reviews on resilience in health systems, and to specifically compare the way resilience is operationalised in empirical studies to the core paradigms and conceptualisations of resilience from a broader set of domains (specifically, engineering sciences, socio-ecological sciences, organisational resilience, and community resilience). We thus take up the unique task, to review the paradigms and approaches to resilience, and map them on the different subsystems of the health system to which they are applied. Rather than bypass the possible variations in conceptual frameworks, we sought to track them; and thereby identify the relationship between conceptual origins showed in the literature, which parts of the health system they focus on, and the aspects of resilience used.
+
+To achieve this objective, we had two specific sub-objectives which guided our search and review method:To characterise the empirical studies dealing with resilience in health systems by (i) types of disasters, threats or events that have triggered these studies, (ii) the part of the health system covered, and (iii) the resilience concepts used in these studies.
+
+To provide a review of reviews to show the various resilience paradigms and conceptualisations used across the health literature already synthesised by existing reviews.
+
+Conceptualisations of resilience in other domains influencing our review
+
+The word resilience stems from the Latin resilio, or ‘to jump back’ [5]. Resilience has double roots in socio-ecological systems and in psychology. In psychology, research has focused on the ability of individuals to deal with trauma and extremely adverse events (Comes et al., 2019 [6]). Studies focus on personality traits that help defend against exposure to extreme stress; this includes aspects such as meaningful purpose, agency and a growth mindset [7]. Taking a systems- rather than an individual perspective, in this paper we do not focus on psychological resilience.
+
+In socio-ecological systems, the concept of resilience was introduced in Holling’s seminal paper to characterise the ability of a system to evolve and adapt under shocks and stresses [8]. Holling’s work inspired a rich body of work in fields ranging from resilience of ecosystems to climate adaptation [9, 10]. Resilience in this realm is often defined as ““the capacity of a system to absorb disturbance and reorganize while undergoing change so as to still retain essentially the same function, structure, identity, and feedbacks” [11], or the ability to persist by changing. This evolutionary perspective stresses the emergence of systems properties, and the rise of rare events, which “can unpredictably shape structure at critical times or at locations of increased vulnerability” [12]. This notion of resilience, however, is in contrast with the need for planning and decision-making, and does not fit the long lead-times and life cycles that are typical for decisions in health care planning and management.
+
+In engineering, resilience is largely used to refer to the ability of some system to rapidly return to a single state of equilibrium or stability after a disruption, thereby ensuring continued functioning and rapid recovery from stress and disturbances [13, 14]. Often, engineering resilience is associated with robustness, broadly understood as the ability to withstand shocks and ‘bounce back’ to the same performance level. These principles have been instrumental in identifying critical points in complex, interdependent infrastructure networks [15], analysing disruptions [16] or for designing new infrastructures and tools [17]. However, these approaches do not explicitly incorporate aspects of adaptation and transformation that socio-ecological systems or community resilience encompasses.
+
+From the perspective of social-ecological resilience, which puts forward the concept of resilience as a non-equilibrium notion, there are important links to participation and self-organisation that are common to community resilience and the social capital theories of resilience [18, 19]. These concepts focus on the networked sets of capacities that a community or organisation can generate, in order to be(come) resilient [20]. While community resilience focuses on the adaptive capacity of communities and their abilities to respond [20], organisational resilience seeks to explain the features of highly resilient organisations [21, 22]. These concepts are also prominent in the disaster resilience literature, where resilience has been promoted as a way to analyse and understand the reaction of a system to a hazardous event, promoting activities such as improving coping capacities and livelihoods [23].
+
+Overall, we observe three major principles that are meant to improve resilience: reducing impacts or consequences (robustness), reducing recovery time (absorption), and reducing future vulnerabilities (adaptation and transformation). These principles are represented to a different degree in the four paradigms that we are investigating here: socio-ecological systems resilience [8], engineering resilience [14, 24], community resilience [20], and organisational resilience [21, 22].
+
+For our study, we sought to look for instances in which these concepts were used, addressed, or referred to, either in the empirical studies (aim 1 above) or in the reviews (aim 2 above).
+
+Methods
+
+We describe our work as a scoping review of empirical studies and reviews, which we explain as follows: We first searched for any studies relating to resilience and its accompanying definitions in the health literature, and applied inclusion/exclusion criteria (see full details below). We then divided our included studies into two categories to match our sub-objectives above: empirical or non-review studies were analysed according to the characteristics described in sub-objective (1) above, while all reviews were reviewed separately and key resilience themes and concepts were extracted for sub-objective (2). The results from both components were analysed together to satisfy our overarching objective. These components are conceptualised in Fig. 1.Fig. 1 Overview of the two sub-objectives for our study
+
+Search method
+
+We expanded the search string and method used by Turenne et al. 2019 [25], who provided a conceptual analysis of health systems resilience, by adding broader search terms that enabled us to include regional, local or care provider-based empirical studies. We also limited our search to PubMed, as our focus was to identify specifically how the health literature conceptualises and uses ‘resilience’ and compare this analysis to other disciplinary domains in our analysis and discussion. We conducted our search on 16 June 2021 which yielded 2773 results (see Supplementary file A for PRISMA flowchart); and the full search string is provided below:(((“resilien*”[Title/Abstract]) OR ("coping strateg*"[Title/Abstract]) OR ("system responsiveness"[Title/Abstract]) OR ("system adaptation"[Title/Abstract])).
+
+AND ( ("health* system*" [Title/Abstract]) OR ( (“health systems plans" [MeSH Terms]) OR ( "Health Planning/organization and administration"[Mesh])) OR ("Public Health/organization and administration"[Mesh]) OR ( "Organization and Administration/organization and administration"[Mesh] OR "Organization and Administration/prevention and control"[Mesh] OR "Organization and Administration/supply and distribution"[Mesh]) OR ("comprehensive health care/organization and administration"[Mesh]) OR ("Public Health Administration"[MeSH]) OR ("Public Health Systems Research"[MeSH]) OR ("health policy"[MeSH]) OR (national health programs/organization and administration[MeSH]) OR ("efficiency, organizational" [MeSH]) OR ("Health Services/organization and administration"[MeSH]))).
+
+AND ("english" [Language]).
+
+To remain up to date with the latest literature, and in response to helpful feedback from one of our reviewers, we updated our search in June 2023 which yielded a further 796 results. These are not included in the empirical study review (sub-objective (1) in Fig. 1), but we did include the extra n = 23 reviews we found in the full-text review analysis (sub-objective (2)).
+
+Eligibility criteria
+
+For the analysis of empirical studies (sub-objective (1) in Fig. 1), we included studies if they met the following criteria:Context: The study is conducted within any part of the health system (including primary care or social care settings, national decision-making, public health local or regional authorities). Individual psychological resilience (of patients or of the workforce) were excluded, unless the study explicitly related such individual resilience as a contributor to the resilience of the system.
+
+Process: The study relates to any aspect of resilience including, for example, adaptation, coping mechanisms, learning from a shock or disaster (see below for ‘resilience concepts’ used in data extraction and analysis).
+
+Study type: Commentaries, editorials, news articles and conference proceedings were excluded.
+
+Language: Only studies in English were included.
+
+Time period: No date limitations were set.
+
+For eligibility in the full-text review of reviews (sub-objective 2 above), we applied the same criteria, except for study type, since this had to be a review with an included search and analysis method (e.g., scoping review, systematic review, narrative review).
+
+Study selection
+
+We used the platform ‘Rayyan’ for screening the titles and abstracts. Three reviewers piloted the screening based on the inclusion/exclusion eligibility criteria. Two reviewers rescreened these relevant/possibly relevant records and we resolved the disagreements in group meetings. We followed arbitration by a third reviewer.
+
+Following study selection, the studies were divided into two categories (Fig. 1): (a) empirical studies that concerned resilience of the health system, and (b) reviews (any method included). This resulted in n = 87 articles included in part (a) and n = 30 articles included in part (b) the review of reviews (see Supplementary file A for our adapted PRISMA-Scoping reviews flowchart). The following steps (data extraction and analysis) were conducted separately and their associated methods are reported in two parts below.
+
+Data extraction and analysis
+
+Data analysis for sub-objective 1: statistical analysis of empirical studies.
+
+While the studies included in these statistical analyses were not reviewed in full, the following data from these articles were extracted:General study publication information: This includes publication date, journal, authors, title, location of study (country).
+
+Types of threat: This refers to the type of threat, event or disaster studied, including COVID-19, Ebola, environmental disasters, etc.
+
+Part of the health system covered in study: This included health system (general/unspecified), community health workforce, primary care, community formal or informal actors (non-health), secondary care (hospital), public health (national, prevention), public health (national), regional/local public health organisations.
+
+Resilience paradigms: To understand the use and evolution of the resilience concept and its characteristics within health systems research, we analysed the articles according to the underlying resilience research paradigm. We searched for the different resilience domain perspectives as outlined above. As we were aiming to embed the health resilience studies into the broader resilience discourse, we here focused on links to the existing fields, rather than on the emerging literature on health resilience. The categories included socio-ecological systems resilience, engineering resilience, community resilience, and organisational resilience.
+
+Resilience aspects: We analysed the resilience phase or aspect considered. Following Manyena et al. (2019) [23] and their comprehensive review of the resilience literature, we distinguish preventive, preparedness, absorptive, adaptive and transformative capacities. We use, whenever possible, the standards defined by UNISDR terminology1 and combine these with recent a recent policy documents for the EU [26] and the IPCC Glossary2:Prevention: “activities to provide outright avoidance of the adverse impact of hazards” (UNISDR)
+
+Preparedness: “activities and measures taken in advance to ensure effective response to the impact of a hazard” (UNISDR)
+
+Absorption: “ability of a system to keep or rapidly recover the same level of performance and service delivery (in terms of quantity, quality, and equity)” [26]
+
+Adaptation: “process of adjustment to changing conditions, including risks and crises” [26]
+
+Transformation: “a profound and often deliberate shift initiated by communities toward sustainability, facilitated by changes in individual and collective values and behaviours” (IPCC).
+
+Resilience approach: Subsequently, we also analysed the approaches that were put forward or studied as a means to achieve resilience (e.g., robustness, agility, redundancy). Rather than diving deeply into the use and meaning of each concept, we here compare how the concepts are used across the different literatures, and which terms dominate.
+
+Further, we followed Meerow et al.’s [27] approach in analysing resilience of what and to what. In the ‘of what’ category, we analysed which parts of the health system were studied, ranging from specific departments within a hospital, to the public health system. Under ‘to what’ we analysed the shocks or stresses that the system under consideration was supposed to, and the drivers for resilience. To understand how the different concepts are applied across paradigms and domains, we developed heat maps that show the frequency of co-occurrence of different terms.
+
+We designed and tested the data extraction form in a spreadsheet shared via Google Sheets to enter: author-title of the review, year and location(s), country in which the empirical study was conducted, threat (to what?), the part of the health system that was studied (of what?), the underlying theoretical paradigm used, the resilience phase, and the concepts that were referred to as means to improve resilience. We also indicated if the related choices were not made specific or could not be inferred from the manuscript. To capture intersections between the concepts, and understand how different capacities are co-evolving or co-used, we analysed and counted all concepts that a paper touched upon, i.e., if a paper referred to e.g., absorption and adaptation, we counted it under both categories.
+
+Where possible, we inferred paradigms and concepts as mentioned from the abstract. If that was not possible, the full papers were scrutinised for additional information. If the category could not be detected, we labelled the paper as ‘not specified’. In addition, because of the breadth of the field, we grouped papers where possible. For instance, papers that referred to ‘rapidly bouncing back’ were categorised under the resilience engineering paradigm.(b) Data extraction for sub-objective 2: review of reviews.
+
+The reviews included in our study (n = 30) were reviewed via full-text review. We designed and tested a separate extraction form in a spreadsheet shared via Google sheets to include: type of review, resilience concepts identified in the review, and theoretical framework or underlying resilience framework or definition.
+
+Results
+
+We present our results in two sections. In part (a) we describe the nature of the included empirical studies that address resilience in health systems. This includes the types of disasters or events that are either used for data or context for these studies, their chronology, the part of health system covered by the studies, methods used, and resulting knowledge contribution of the study. In part (b) we present the results of our full scoping review of reviews, focussing in particular on the way resilience is conceptualised in these papers. In the discussion following this section, we compare and contrast these conceptualisations to the principles of resilience identified within part (1).
+
+(a) Describing empirical studies addressing resilience within health systems
+
+We included a total of n = 87 articles in the descriptive analysis, available in full in a table in Supplementary File C.
+
+Nature of empirical studies on resilience in health systems
+
+Our included articles are drawn from a broad spectrum of journals covering different fields and domains within healthcare (Fig. 2), with the highest number of publications in global health (n = 15, 17%) and public health (n = 13, 15%). These studies are also published in interdisciplinary journals, or in other domains, such as emergency management (n = 4, 5%) or computer science (n = 3, 3%).Fig. 2 Distribution of journal categories considered in this review (n = 87)
+
+Location and setting of empirical studies on resilience in health systems
+
+The settings in which these included studies were conducted were distributed fairly evenly across Europe (n = 15, 17%), Africa (n = 15, 17%), and North America (n = 13, 15%), see Fig. 3. For Asia, we distinguished the Middle East (n = 8, 9%), where papers often focus on conflict and refugees (e.g. [28, 29], from South Eastern Asia and China (n = 6, 7%), where studies largely focused on emergency management departments [30, 31]. Fewer studies were conducted in Oceania (n = 4, 5%) South America (n = 3, 3%) and Central America (n = 1, 1%). Few papers reported to focus generally on low- and middle-income countries (LMICs) (n = 2, 2%) or global health systems issues (n = 1, 1%). A total of 18 papers (21%) did not specify the location of study within the title or abstract.Fig. 3 Distribution of study locations (n = 87)
+
+Threats prompting empirical studies on resilience
+
+By categorising the studies according to their year of publication and the associated ‘threat’ (disaster, emergency etc.) that was studied, we were able to observe patterns in how these threats prompted resilience research over time (Fig. 4). The intersection of health and resilience clearly has gained importance in the academic discourse with the majority of papers published since 2018 (n = 47, 54%). Most recently, the COVID-19 pandemic created another peak in health systems research (starting 2020, n = 21 or 24%), after a slight drop in 2019. The 2021 data covers the papers published up to June 2021, when we conducted our search for empirical studies.Fig. 4 Identified literature on health system resilience (n = 87) organised by threat or type of challenge and year (from 2004 until June 2021)
+
+A majority of publications (n = 49, 56%) made specific the resilience challenge addressed, while 38 publications were generally referring to health systems resilience, driven by the general complexity and uncertainty that the health system is exposed to, but without referring to a clear threat or challenge. For the publications that refer to a threat, infectious diseases and epidemics (n = 24, 27%) formed the largest group of publications. Clearly, this category was dominated by COVID-19 (n = 13) and Ebola (n = 8) with other infectious diseases playing a minor role.
+
+Many of the COVID-19 publications reported on the lessons learnt from the first wave of the pandemic across different countries [32–35]. The publications about Ebola (which gained prominence in 2015), were published from 2015 to 2020, speaking to the long-term challenges to the health system. While the initial publications focus on the immediate impact [36], the later studies shift to the development of the health system [37, 38] and community resilience or community health workers [39–41].
+
+Somewhat surprisingly, natural disasters find relatively few mentions with a total of 5 publications (6%) that cover Hurricane Sandy e.g., [42, 43] and earthquakes in Central America (e.g., Haiti [44]) and South Eastern Asia (Fukushima e.g., [45]). Economic stresses and shocks (n = 7, 8%) have gained importance in the aftermath of the 2011 financial crisis across geographical locations (e.g., [46–49]). The ongoing war and conflicts in the Middle East and the subsequent refugee crises have inspired a range of health resilience papers since 2016 (n = 9, 10%) [28, 29, 50].
+
+Components of the health system covered by empirical studies, compared to threats
+
+Focusing on the question which parts of the health systems are the objects of investigation, Fig. 5 shows that most studies focus on the health system generally, without further specification (n = 40, 46%), followed by secondary care (specifically, hospitals; n = 21, 24%). The articles focussed on health systems generally cover diverse challenges and specific threats ranging from conflict and economic crises to antimicrobial resistance [51–54]. In contrast, the resilience of hospitals is often studied in general terms, with the majority of papers studying the regular disruptions, uncertainties and complexities with which a hospital is confronted [55–58], rather than specific and/or external shocks or stresses. Primary care (n = 9, 10%) is mostly discussed in a post-disaster or conflict context [53, 59, 60]. National public health organisations (n = 8, 9%) [61], regional and local public health care organisations (n = 6, 7%) [62] and community actors (formal, informal and workforce) (n = 4, 5%) (eg [40]) have received less attention. Figure 5 shows that the publications on communities were driven by the literature on Ebola (e.g. [39, 40, 63]), which also have promoted a shift towards community.Fig. 5 Literature on health resilience (n = 87) organised by location in the health system (resilience of what?) and threat or type of challenge (resilience to what?)
+
+Aspects and phases of resilience used in empirical studies
+
+Conventionally, the health resilience literature distinguishes three main capacities or outcomes: absorption, adaptation and transformation [1, 64]. However, our findings show that many of the empirical studies we found focussing on resilience—given that they are rooted in the risk, safety, and emergency management domain—also focus on prevention and control (e.g. [31, 46]) as well as preparedness [65–67] as key capacities and outcomes. Especially in response to COVID-19, several authors focus on preparing for or preventing pandemics (e.g., [33, 68, 69]). While conventionally, these outcomes are considered as a part of risk management rather than resilience [26], the health resilience literature integrates both realms under the umbrella of resilience.
+
+Figure 6 shows that the idea of absorption, or rapidly bouncing back, is the most used resilience aspect (n = 35, 40%) with a wide range of applications, ranging from communities recovering from natural disasters [42] to the ability of emergency departments to absorb a surge of patients [30, 70] or external disturbances [71]. Preparedness (n = 25, 29%) and adaptation (n = 15, 17%) follow. Prevention & control (n = 8, 9%) are primarily referred to in literature that describes resilience to epidemics and infectious disease (see above). Transformation (n = 5, 6%) has received limited attention [49], often in conjunction with other qualities, such as adaptation (e.g., [59]. And while the resilience literature often stresses the need to absorb, adapt and recover, only two publications (2%) refer to all three capacities [28, 50]. Strikingly, both of these publications focus on the situation of Syrian refugees.Fig. 6 Analysis of specific resilience capacities or outcomes (n = 87)
+
+Underlying resilience paradigm or disciplinary contributions in empirical studies
+
+To track how these different research traditions and paradigms are influencing the field of health resilience, we analysed the publications for mentions of the underlying field. Most publications do not make the research tradition in which they are embedded specific (n = 36, 41%, e.g. [72–74]). Of those that make explicit an underlying research paradigm, resilience engineering is the most prominent (n = 19, 22%, e.g. [60, 75, 76]). This finding is also in line with the prominence of ‘absorption’ or the rapid response to shocks discussed earlier. Figure 7 highlights that resilience engineering is applied throughout most health subsystems, but is especially prominent in secondary care (hospitals), e.g. [30, 56, 77]. Community resilience and organisational resilience are following (n = 12 and n = 10 respectively). Community resilience approaches find application in both local and regional public health organisations [65, 78], in analyses of the formal and informal community actors or workforce [41, 63] as well as in the study of the health system as a whole [37, 79]. Organisational resilience is applied to the different levels of public health organisations (local / regional) [31, 80] as well as secondary care (hospitals) [66, 70, 81]. The social-ecological systems roots of resilience find the least application, both in the health system [51] as well as within hospitals [47], confirming our findings of the limited application of transformation in the health resilience literature.Fig. 7 Literature on health resilience organised by location in the health subsystem (resilience of what?) and resilience paradigm (n = 87)
+
+Approach to developing and building resilience
+
+Even broader than the different categories and capacities that constitute resilience are the approaches that are used or analysed to improve or manage resilience in health systems. Most prominently described is the need for surge capacity to respond to a rapid shock such as a natural disaster or an epidemic (n = 18, 21%) (e.g., [45, 79, 82], followed by resilience capacity, as a generic umbrella term (n = 12, 14%, e.g. [28, 37]), trust (n = 8, 9% [83]) and leadership (n = 7, 8% [84]). Other concepts that are broadly used in resilience management or resilience engineering receive surprisingly little attention, such as robustness [85], redundancy [71], flexibility [57] or agility [34] (all below five mentions).
+
+Figure 8 shows the clear divide of the studied approaches to resilience by the different resilience paradigms, also illustrated by the dendrogram, showing the hierarchical relationships between the different uses of the concepts in the discourse. While resilience engineering emphasises the need for concepts and terms such as ‘coordination’, ‘robustness’, ‘flexibility’, ‘teams’ and different ‘capacities’, the discourse in the literature that is rooted in community resilience stresses ‘collaboration’, ‘trust’, ‘training’, and ‘leadership’. Both resilience engineering and community resilience-oriented approaches acknowledge the need for ‘information’ and ‘surge capacity’. Social capital-oriented literature is focusing primarily on the role of ‘networks’, while the organisational and social-ecological systems resilience literatures stress the need for ‘diversity’. Fig. 8 Heatmap and dendogram of the approaches to build and manage resilience for the different resilience paradigms. (socio-ecological systems—social-ecological resilience; ORG—organisational resilience; SoCap—Social Capital; COMM—community resilience; RE—resilience engineering). Mapping only for papers that mention both resilience paradigm and approach
+
+(b) Describing how resilience is conceptualised in the health domain based on reviews
+
+We included a total of n = 30 articles in the review of reviews, included in Table 1 (n = 17 up to June 2021, matching the date of the empirical studies analysed in (a), plus a further n = 23 reviews published after June 2021 up to June 2023). These included systematic reviews (n = 11), scoping reviews and other or non-systematic. Not surprisingly, most of the reviews were published more recently: 2022 (n = 10), 2021 (n = 5), 2020 (n = 4). Most of them identify what constitutes ‘resilience’ in health systems, but only few refer to conceptualisations in non-health domains such as engineering and other sciences for example, Biddle et al. 2020 [1] and Hess et al. (2012) [86]. Many of the earlier reviews refer to the definition of resilience by Kruk et al. (2017), which includes being adaptive, self-regulating, diverse, aware, and integrated [87]. These characteristics draw on socio-ecological systems paradigms but this allusion is not explicitly mentioned in the reviews using them as a conceptual framework. In later reviews, authors mostly appealed to the domains of resilience identified by Blanchet et al. (2017) [88], which includes the concept of transformation, but that aspect is not in fact widely used (e.g. [1]).Table 1 Table of reviews used for full-text review (n = 30)
+
+Included review reference	Type of review	Resilience phases, concepts and paradigms indicated in the paper (and underlying framework, if specified)	
+Bayntun, 2012 [89]	systematic review	(includes reference to general WHO framework)	
+Hess et al. 2012 [86]	literature review	adaptive capacity	
+Bayntun et al. 2012 [90]	systematic review	disaster management as health system strengthening; (includes reference to WHO framework/checklist)	
+Zhong et al. 2014 [91]	literature review	preparedness, adaptation, absorption	
+Curtis et al. 2017 [92]	structured review	preparedness, adaptation (eg building design); role of community	
+McDarby et al. 2019 [93]	scoping review	(includes reference to Kruk et al. 2017 [87])	
+Turenne et al. 2019 [25]	scoping review	adaptation, maintenance, absorption, learning, transformation, withstanding and responding to shocks	
+Khan et al. 2019 [67]	review, followed by delphi	preparedness, prevention/control; community; socio-ecological systems; organisational	
+Nuzzo et al. 2019 [94]	scoping review	transformation, preparedness; (includes reference to Kruk et al. 2017 [87])	
+Chamberland-Rowe et al. 2019 [95]	systematic review	preparedness, adaptation; transformation (opportunism), absorption; (includes reference to Kruk et al. 2017 [87])	
+Ayanore et al. 2019 [96]	systematic review	not specific [related to preparedness]; (includes reference to Kruk et al. 2017 [87])	
+Haldane et al. 2020 [97]	rapid review and narrative synthesis	surge capacity/absorption; control; organisational resilience	
+Fridell et al. 2020 [98]	scoping review	adaptation, maintenance, absorption, learning, transformation, withstanding and responding to shocks; resilience engineering	
+Biddle et al. 2020 [1]	systematic review	absorption, adaptation, transformation; (includes reference to Blanchet et al. 2017 [88])	
+Meyer et al. 2020 [99]	scoping review	preparedness; (includes reference to Kruk et al. 2017 [87])	
+Haldane et al. 2021 [79]	literature review	adaptation (toward equity - almost transformation), (not absorption), adapted WHO framework; community engagement; socio-ecological systems; social capital	
+Grimm et al. 2021 [100]	evidence synthesis	adaptation; (includes reference to Kruk et al. 2017 [87])	
+Luke et al. 2021 [101]	scoping review	(hospital) socio-natural disaster resilience; structural & non-structural resilience, infrastructure resilience; (includes reference to WHO hospital safety index tool and 'Senai' framework for disaster risk reduction)	
+Alehi et al. 2021 [102]	systematic review	workforce resilience (organisational)	
+Hasan et al. 2021 [103]	scoping review	responsiveness	
+Sutherns and Olivier. 2022 [104]	scoping review	responsiveness mechanisms; response [to public voice via policy]; (includes references to WHO responsivenes)	
+Foroughi et al. 2022 [105]	systematic review + critical interpretive synthesis	absorptive, adaptive, transformative; (includes references to Barasa et al. 2018 [106]; Thomas et al. [114])	
+Foroughi et al. 2022 [107]	systematic review	adapative capacity, transformation, absorptive	
+Forsgren et al. 2022 [2]	scoping review	workforce resilience, governance, preparedness, everyday resilience, strengthening, learning, [adaptive capacity in relation to chronic stresses], leadership; (includes reference to Barasa et al. 2018 [106])	
+Khalil et al. 2022 [3]	scoping review + interviews	strengthening resilience; hospital resilience; everyday resilience, functionality and safety; in the literature found: absorptive, adaptive, transformative + learning as key aspects; (prevention + preparedness)	
+Falope et al. 2022 [108]	systematic review	elements of resiliency (being aware, diverse, self-regulating, integrated, and adaptive); (includes reference to Kruk et al. 2017 [87])	
+Thu et al. 2022 [109]	literature review	absorbtion, adaptation, transformation; (includes reference to Blanchet et al. 2017 [88])	
+Fleming et al. 2022 [110]	systematic review	absorption, adaptation, transformation + dynamic shock cycle; (includes reference to Thomas et al. 2020 [114])	
+McDarby et al. 2022 [111]	rapid literature review	(embedding resilience into) strengthening, learning, measurable/tangible (lit reviews finds common: awareness, mobilization, self-regulation, integration, diversity, transformation)	
+Ismail et al. 2022 [112]	realist-informed systematic review	absorption, adaptation, transformation; (includes reference to Blanchet et al. 2017 [88])	
+
+Most of the reviews refer to multiple levels or locations at which resilience can be addressed and assessed, and the importance of including stakeholders from service providers to governments to patients themselves in design and planning processes in order to build resilience. The Resilience in Healthcare group [113] in particular notes that patients are part of resilient responses, and draw from their analysis of multiple levels where ‘resilience characteristics’ can be found– ‘individual, team, management and organizational’. Other approaches take up the healthcare system components via the WHO, thus using a modular approach to the system as a whole (eg. Bayntun et al. 2012 [90]).
+
+In terms of resilience aspects or phases, about half the reviews prior to 2021 draw out ‘preparedness’ as a notion covered by their included studies. Hess et al. 2012 [86] take up ‘adaptive capacity’, specifically in relation to climate change; and ‘adaptation’ is further covered by Zhong [91], Chamberland-Rowe et al. 2019 [95], Haldane et al. 2021 [79], while Turenne 2019 [25], Foroughi et al., [105, 107], Thu [109], Fridel et al. 2020 [98], Fleming [110] and Ismail [112], also make explicit mention of ‘transformation’ in addition to adaptation. Transformation and preparedness is also covered in the scoping review by Nuzzo et al. 2019 [94]. However, despite more recent reviews mentioning and identifying the concept of transformation in the studies they reviewed, they note that its application and use is less present in empirical work.
+
+The key messages that stand out from these reviews is the lack of a common definition of resilience [25, 94, 98], and the scarce or underdeveloped use of learning and transformation as concepts operationalised in the empirical literature, which is also in line with our findings from the empirical literature. Furthermore, Nuzzo et al. 2019 point out the lack of implementation frameworks to translate resilience capacities into something that health system actors can employ in response to crises [94]. However, the more recent reviews have started to focus on the importance of operationalising resilience in practice (e.g. [2, 3]). Despite the turn toward community resilience (learning, empowerment) and socio-ecological resilience (self-organization, transformation) concepts being recognized as important—in contrast to the more linear, engineering resilience approaches—this theoretical turn has not (yet) resulted in the adoption of those concepts in practice.
+
+Discussion
+
+Health systems operate at the intersection of technical and social, and possibly social-environmental, systems. Figure 9 shows that they are complex systems, ranging from community services to highly specialised experts in hospitals and requiring local, regional, and national coordination. Moreover, they are embedded in the broader social-environmental, socio-economic, governance and infrastructural context (see Fig. 9). These systems shape and influence the shocks and stresses that the health system may be exposed to (black boxes in Fig. 9), but also determine its capacity to rapidly respond.Fig. 9 The health system as an adaptive complex system, and its interdependencies to other systems, grey boxes indicate shocks or stresses to health system
+
+This breadth of applications and resilience challenges, as well as focal areas and time horizons considered is reflected in the health resilience literature: we found a wide variety of resilience approaches and schools, published in various health journals as well as in journals from neighbouring disciplines, most notably emergency management & computer science. Not surprisingly, applications that focus on physical infrastructure or built environment focus on resilience engineering, and bring approaches for improved planning, management, and operations of these infrastructures. For community, governance, or dealing with socio-ecological change, however, other concepts are vital that focus on self-organisation, learning, empowerment, and transformation. Because of the nature of the health system as a complex adaptive system of systems, the challenge to resilience in health is integrating these different facets and paradigms of resilience, because they all are vital to the health system.
+
+In our study, we trace the roots of these resilience approaches to build and review the underlying schools of thought or paradigms and approaches to resilience. This produces a unique map, distinguished from previous reviews, placing concepts in alignment with the different subsystems of the health system to which they are applied. Further, by including both an analysis of empirical studies and review of reviews, we were able to validate our own preliminary findings: first, the empirical studies analyses served to identify what non-health domain concepts were present and in which patterns; and the reviews served to identify what resilience concepts were already being discussed in the literature. Putting the two together helped us formulate our conclusions and identify gaps in theoretical concepts from other domains present in the literature. Generally, our review shows that the field is fragmented, especially in terms of approaches and ‘schools of thought’ from non-health domains appealed to in the literature, as well as in terms of the health systems settings in which these are used. In the following paragraphs, we address the implications of these results.
+
+First note that the intersection of health and resilience clearly has gained importance in the academic discourse with most papers published since 2018 (Fig. 4). This is a continued trend that confirms the findings of the review by Biddle et al. (2020) [1]. What our analysis further highlights is that most studies focus on either the resilience of health systems generally (and thereby responding to an external shock or stress), or on resilience within hospitals and thereby to the inherent uncertainty, volatility, and dynamics that are typical for the health system. Less attention has been given to community-based care, whether formal or informal, although the shift towards community did explicitly take place in reports on studies that focussed on responses to the Ebola outbreaks.
+
+Second, conventionally, the resilience literature distinguishes three main capacities or outcomes: absorption, adaptation and transformation [1, 64]. However, our findings show that many of the empirical studies in health– especially those rooted in the risk, safety, and emergency management domain—focus on prevention and control as well as preparedness as key capacities and outcomes. While traditionally, these outcomes are considered as a part of risk management rather than resilience, the health resilience literature integrates both realms under the umbrella of resilience. The most used resilience aspect is ‘absorption’ or ‘rapidly bouncing back’ (Fig. 6), followed by preparedness and adaptation. What has previously received less attention (both in our empirical studies and in the reviews) is ‘transformation’, although this was pertinent in Ebola related studies. Outside of these studies, most focussed on preparedness and absorption, while it may be that COVID-19 has prompted a shift towards adaptation. However, the three combined aspects of absorbing, adapting and recovering seldom appear together, despite the resilience literature stressing the need to refer to all three.
+
+Thirdly, of the various resilience paradigms influencing empirical work, ‘resilience engineering’ is the most prominent one mentioned, which is in line with the prominence of ‘absorption’ or ‘rapid response’ also highlighted. These concepts are closely linked as resilience engineering focuses on a single state of equilibrium or stability to which a resilient system rapidly returns after a shock. Despite being mentioned in most health subsystems in our included sample, it is especially prominent in hospital settings (Fig. 7). ‘Community resilience’ approaches find applications primarily in local and regional public health organisations, in studies of the health system as a whole (unspecified) and, not surprisingly, in formal and informal community actors. ‘Organisational resilience’ is applied to the different levels of public health organisations (local / regional) as well as secondary care (hospitals). The ‘social-ecological systems roots of resilience (relating to ‘transformation’ and multiple equilibria) find the least application, both in the health system as well as in hospitals.
+
+Fourth, the different theoretical and conceptual roots also have implications for the approaches that are considered to build or improve resilience. While resilience engineering emphasises the need for coordination, robustness, flexibility, teams and different capacities, the literature that is rooted in community resilience stresses collaboration, trust, training, and leadership. Both resilience engineering and community resilience-oriented approaches acknowledge the need for information and surge capacity, as noted in the reviews we reviewed. Social capital-oriented literature is focusing primarily on the role of networks, while the organisational and social-ecological systems resilience literature stress the need for diversity.
+
+As such, our findings show that the contemporary definitions of health systems resilience, along with the approaches to measure or build resilience, have not yet explicitly addressed important conceptual dilemmas or tensions apparent in the health resilience literature.
+
+These conceptual dilemmas are related to:Paradigm & school: as health systems resilience is situated at the intersection of engineering, social, organisational, community, and socio-ecological systems resilience, bridges between the different schools of thought need to be found that allow for an integration of approaches and operationalisations. This concerns especially the question of a single equilibrium (restorative; bouncing back) versus multiple equilibria and transformational change.
+
+Temporality: intricately connected to the question of paradigm is the temporality considered. We find that the health resilience literature considers a wide variety of time horizons, even though there is a dominance of shorter time spans. The single equilibria approaches consider a relatively narrow frame to absorb and respond to a shock or stress. This is in contrast with the community and socio-ecological systems based approaches that stress the need to build trust, change, adapt and transform the health system. Without a clear definition of time horizons, measuring resilience becomes a conundrum, as different time horizons will lead to different results.
+
+Normativity: resilience is both used as a descriptive concept, to objectively measure how long it takes a system to recover performance (absorption), and as a normative concept, connected to terms such as inclusion, distributive justice, or sustainability. Especially the question of how values are or should be embedded into different resilience definitions and measurements remains open, making the underlying choices opaque and implicit. The lack of a clear discussion around the values that are conveyed through resilience, such as whose resilience is measured (and over what time horizon) has severe repercussions on our ability to measure resilience.
+
+Building resilience: connected to the lack of a clear stance on what constitutes resilience, or how it can be measured, is the broad variation of approaches that are introduced to improve resilience. While within engineering-oriented approaches, there is an emphasis on robustness, redundancy, and surge capacity, qualities such as trust, distributive justice, or adaptive capacity are stressed in the social-oriented resilience approaches. However, because the health system is an interconnected system-of-systems, what is needed is a toolkit of resilience building approaches that addresses different facets of resilience across different parts of the health system. Further, it is not known how the different approaches of building resilience would propagate and influence resilience in other areas of the health system.
+
+These fundamental theoretical and conceptual dilemmas lead to a fragmentation of resilience concepts across the different realms of the health system (see Fig. 9) and make it difficult to develop a comprehensive definition of health systems resilience.
+
+Limitations
+
+Our search was conducted for empirical articles up to June 2021, and for reviews up to June 2023. Given the ongoing COVID-19 pandemic and the continued interest in health system resilience, we are likely to be missing more recent articles that have covered the field further. Articles included in the descriptive statistics were tagged manually (for ‘threat’, ‘resilience concept’ and ‘part of the health system’) upon reading the title and abstract. We note that reading only titles and abstracts for half of our study is a potential limitation to our analysis. For example, it may be that the full text of these n = 87 articles would have resulted in different tags (for example, while the abstract may have referred to COVID-19 in its abstract, the full paper itself may have focussed on health system resilience more generally, without reference to a specific threat). Similarly, many articles were labelled as ‘no specific threat’, while in the full text itself, reference might have been made to specific threats such as Ebola or a natural disaster. To mitigate this type of error, where there was ambiguity in the abstract, the full text was read by one author so that the appropriate label was found for the article in question. Therefore, for the purposes of this portion of our results, where our aim was to understand the most salient and dominant theories, paradigms, approaches and threats relating to resilience, the need for full-text review was on a case-by-case basis and not required for the full set of articles. By contrast, for our second set of results, full-text review was conducted on the included reviews, since our intention was to give an overview of the discourses in the field addressed in existing reviews. Finally, we note that our databases were limited to those via Pubmed, and a wider search (e.g. including EMBASE) could have identified further studies to be included in our review, and to the English language, also limiting the global publications that could have contributed to our findings.
+
+Conclusions
+
+While there are valuable lessons to learn about health system resilience through existing empirical work and reviews, the literature does not yet address important conceptual dilemmas relating to the underlying research paradigm or school, temporality, normativity, and building resilience. These fundamental theoretical and conceptual dilemmas and lead to a fragmentation of resilience concepts across the different realms of the health system make it difficult to develop a comprehensive definition or application of health systems resilience.
+
+The health system is characterised by connections within and between the complex and adaptive sub-systems, ranging from community actors to local, regional, or national public health organisations to secondary care. Without a comprehensive definition and framework that captures these interdependencies, operationalising, measuring and improving resilience becomes challenging. We suggest that the different parts of the health systems should be conceptualized as networked subsystems. This will allow researcher to study resilience at the intersection of the different realms, and to understand how resilience propagates through different parts of the health system.
+
+Supplementary Information
+
+Additional file 1. 
+
+Additional file 2. 
+
+Additional file 3. 
+
+Acknowledgements
+
+Not applicable.
+
+Authors’ contributions
+
+SHK, SC and TC conceptualised the study. SHK, SC, TC and FF piloted the search strings and FF and SHK executed the search. SHK, SC, TC and FF screened the titles and abstracts to decide on the articles included for analysis within the Rayyan platform. TC, SHK and ERS cleaned and analysed the data extracted from the Rayyan platform. SHK, SC, TC, and RB analysed and read the included studies and wrote the manuscript.
+
+Funding
+
+Not applicable.
+
+Availability of data and materials
+
+All data included in the analysis in this study are available within the manuscript itself as supplementary files.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Not applicable.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+1 https://www.unisdr.org/files/7817_7819isdrterminology11.pdf
+
+2 https://www.ipcc.ch/sr15/chapter/glossary/
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Pregnancy Childbirth
+Journal ID: BMC Pregnancy Childbirth
+NLM Journal ID: 100967799
+
+BMC Pregnancy and Childbirth
+
+EISSN: 1471-2393
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12512377
+PMID: 41074011
+DOI: 10.1186/s12884-025-08015-y
+Article ID: 8015
+Article version: 1
+Subjects: Research
+
+Exploring perinatal mental well-being: a concept analysis from conception to one year postpartum
+
+Massaer Mia mia.massaer@zas.be mia.massaer@student.uantwerpen.be
+1
+Franck Erik 1
+Van Haeken Sarah 2 3
+Bogaerts Annick 3
+Timmermans Olaf 1 4
+1 https://ror.org/008x57b05 grid.5284.b 0000 0001 0790 3681 Faculty of Medicine and Health Sciences, Centre for Research and Innovation in Care (CRIC), University of Antwerp, Campus Drie Eiken, Gebouw S, Universiteitsplein 1, WilrijkAntwerp, 2610 Belgium
+2 https://ror.org/03zq0dg86 grid.451396.c 0000 0004 5905 9058 Research & Expertise, Resilient People, UC Leuven-Limburg, Quadrigebouw, Wetenschapspark 21, Diepenbeek, 3590 Belgium
+3 https://ror.org/05f950310 grid.5596.f 0000 0001 0668 7884 Faculty of Medicine, Department of Development and Regeneration, Women and Child, KU Leuven, Building ‘Onderwijs en Navorsing 2’, Herestraat 49, Louvain, 3000 Belgium
+4 https://ror.org/047cqa323 grid.448873.4 0000 0004 0477 8901 Research Group Healthy Region, HZ University of Applied Sciences, Edisonweg 4, Vlissingen, 4382 NW Netherlands
+Electronic publication date: 2025 Oct 10
+Publication date: 2025
+Volume: 25
+Electronic Location ID: 1068
+Received 2025 Mar 16; Accepted 2025 Jul 31
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Concept analysis, Perinatal mental well-being, Prenatal mental health, Postnatal mental health, Perinatal psychological well-being, Perinatal emotional well-being, Perinatal social well-being, Positive mental health, Maternal mental health, Midwifery
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2025
+
+Ÿ==============================Ÿ
+Background
+
+Perinatal Mental Well-Being (PMWB) is critical for the health of both mothers and children. Despite its importance, a clear, objective, and measurable definition remains lacking. This study aimed to explore and define PMWB from conception to one year postpartum.
+
+Methods
+
+A concept analysis was conducted using Walker and Avant's framework. A comprehensive literature search was performed across various sources, including dictionaries, thesauri, encyclopaedias, and textbooks related to General Mental Well-Being, midwifery, psychology, and mental health journals, alongside international databases. The search was performed without date restrictions and included publications up to November 2024. The primary criterion for inclusion was relevance to the definition of PMWB. Data were analysed using the constant comparison method and managed with MAXQDA Analytics Pro (24.4.1). Identified meaning units were coded into codes and subcodes based on the attributes of PMWB. The review included twenty articles, yielding 241 extracted codes, which were subsequently categorized into key attributes and subdimensions of PMWB. The methodological quality of the included studies was assessed using Joanna Briggs Institute (JBI) tools or alternative criteria, depending on study type. The analysis showed that PMWB has three key aspects: Emotional (Hedonic), Psychological (Eudaimonic), and Social Well-Being, each with unique characteristics. PMWB is also intricately connected to other dimensions of the General concept of Perinatal Well-Being, including Physical, Spiritual, Economic, and Ecological factors. These connections highlight the complexity and dynamic nature of PMWB.
+
+Conclusion
+
+PMWB is a multidimensional concept that integrates emotional, psychological, and social domains and extends to other dimensions such as Physical, Spiritual, and Economic Well-Being. This holistic perspective captures the diverse scope of maternal mental health in the perinatal period. Given the evolving nature of PMWB, detailed and adaptable assessment tools are crucial for reflecting women's experiences and guiding timely interventions to improve long-term outcomes for mothers and their children.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12884-025-08015-y.
+
+Background
+
+Perinatal Mental Well-Being (PMWB) is increasingly recognised as a cornerstone of maternal and child health, from conception to the first year postpartum [1–7]. During this critical period, the mother's mental health not only influences her own Well-Being (WB) but also profoundly impacts her child’s physical, cognitive, and emotional development [2, 8]. Maternal mental health disorders, including depression and anxiety, have been linked to insecure mother–child attachment, higher risks of child neglect, and a greater prevalence of physical and behavioural issues in children [6, 7, 9–11]. These findings underscore the necessity of integrated support systems to safeguard and enhance women’s mental health throughout the perinatal period [12, 13].
+
+Although often associated with pregnancy and postpartum, the perinatal period begins at conception. This early stage can already trigger strong emotional responses, identity shifts, and psychological adjustments. From the moment a woman becomes aware of her pregnancy, she may experience joy, anxiety, or ambivalence. These early reactions are part of the evolving Mental Well-Being of expectant mothers. Including conception in the scope of Perinatal Mental Well-Being allows for a more comprehensive understanding of maternal psychological needs [14, 15].
+
+Impact of PMWB on mother health and barriers
+
+Given the considerable influence of PMWB on maternal and child health outcomes, there is an urgent need for governmental and policy-level support, interventions to optimise PMWB, and preventive measures against mental health issues. Around 1 in 5 women experience mental health issues, such as anxiety and depression, during the perinatal period [1, 2, 16–19]. Most of the present knowledge about PMWB comes from studies on negative affect and mental disease. It is time to rethink this concept, shifting the focus away from negative mental outcomes and towards optimising and enhancing PMWB. This concept should not be seen as merely the absence of psychological distress. Instead, it refers to a dynamic and multidimensional state of emotional, psychological, and social flourishing. This broader perspective is supported by Keyes, who defines mental health as a complete state that combines the absence of illness with the presence of Well-Being [20]. His model invites a shift towards a strengths-based view of PMWB, where positive functioning becomes central. Barry expands on this by highlighting how mental health can be actively promoted. She points to resilience, social connectedness, and self-management as key elements, particularly within maternal care and public health policy [21, 22]. Ryff adds another layer with her eudaimonic perspective, which emphasises meaning, autonomy, and personal growth as essential to psychological Well-Being—elements that are especially relevant during the perinatal period [23].
+
+The World Health Organization has also advocated for a more health-promoting approach to mental health. Rather than focusing solely on the treatment of illness, WHO promotes supportive environments that foster Well-Being, particularly in maternal and child healthcare [3–5]. These perspectives not only promote a strengths-based understanding of PMWB but also align with principles of preventive care, emphasizing early support and sustained Mental Well-Being throughout the perinatal period.
+
+Without proactive approaches, mental health issues in the perinatal period often remain undiagnosed, reinforcing the saying"there is no health without mental health" [2, 21, 24]. Despite its importance, up to 50% of perinatal depression cases remain unrecognised and untreated in midwifery and obstetric settings [25, 26]. This makes perinatal depression the most underdiagnosed and untreated obstetric complication [25–27]. This oversight results in significant suffering for women and their families, making their decline in health and PMWB greater than it should be. At the same time, the economic costs are high [28–31]. Due to loss of productivity, increased expenditure on maternal health and obstetric-specific expenditures. In addition to the tax burden, maternal suicide is a leading cause of maternal mortality, with suicide rates peaking in the postpartum period [32, 33]. The stigma associated with mental health remains fundamental in the barriers to seeking help​ [25, 28, 30, 31, 34, 35].
+
+Role of midwifery in supporting PMWB
+
+Enhancing maternal mental health has the potential to support early childhood developmental outcomes and reduce long-term healthcare costs associated with mental health treatment. The perinatal period plays a critical role in the health of both mother and child. Including this concept in public health strategies may promote healthier families and improved child development. This approach benefits overall public health [1]. Routine antenatal care needs to include optimisation of PMWB and psychosocial support. There is a gap in early detection, screening, and support [36]. Midwives, the lead professionals in perinatal care, have frequent contact with women and can educate, support, and identify at-risk people. Midwifery care, based on principles of continuity of care, woman-centred care, informed choice, and advocacy, may facilitate uptake in perinatal mental health care [28, 37]. Currently, there is no consensus on the core components of PMWB, and there is also no established'gold standard'for its measurement.
+
+Despite increasing attention to PMWB in research and practice, its conceptualisation remains ambiguous and inconsistently applied [14, 15]. Terms such as “maternal mental health,” “Well-Being,” and “perinatal emotional health” are often used interchangeably, leading to confusion about what PMWB entails [14]. Moreover, existing measurement tools tend to focus on the absence of distress rather than on the presence of positive mental states [21]. This lack of conceptual clarity limits the development of effective screening instruments, hinders communication between professionals, and prevents the design of targeted interventions. Therefore, a concept analysis is necessary to define the core attributes, antecedents, and consequences of PMWB [38, 39]. It provides a theoretical foundation to better understand, assess, and promote maternal mental health during the perinatal period.
+
+Objectives
+
+This study aims to address challenges in defining and measuring PMWB by exploring its dimensions and proposing tools for tailored support.
+
+Methods
+
+This review utilised the concept analysis approach outlined by Walker and Avant [38]. This is a method of concept analysis that borrows from linguistic philosophy ways of reducing complex concepts into simpler forms and breaking them down. It is particularly suited for exploring complex constructs such as PMWB, where poorly defined use of terms can result in apparently inconsistent communication among researchers and clinicians [38]. The method identifies the core attributes, antecedents, and consequences involved in the definition refinement process and gives helpful guidance regarding its application within maternal health contexts [39].
+
+This structured approach has the advantage of clarity about PMWB, which is particularly necessary when constructs within the field are not standardised. Identifying empirical referents is essential, establishing measures of PMWB as reliable and valid. This is a critical step in developing evidence-based interventions within perinatal care. conceptualisation is best viewed, however, as an evolving process; meaning knowledge that is changing rather than a static and immutable entity [40].
+
+Search strategy
+
+An extensive literature search was conducted across various databases and search engines without restrictions on the publication date, up until November 2024. The databases included PubMed, Cochrane, Trip Medical Database, PsycInfo, Google Scholar, CINAHL, Medline via OVID, and Web of Science. Grey literature was included in the search strategy through Google Scholar and manual snowballing using reference lists. However, only sources that met the predefined inclusion and quality criteria were retained for the final analysis. The search strategy involved a combination of keywords and MeSH (Medical Subject Headings) terms, combined with individual keyword searches, to ensure comprehensive coverage.
+
+The complete search strategy is summarised in Table 1.Table 1 Search strategy and search terms used in the literature review
+
+Search Component	Details	
+Databases searched	PubMed, Cochrane, Trip Medical Database, PsycInfo, Google Scholar, CINAHL, Medline via OVID, Web of Science	
+Search period	No restriction on publication date; search performed until November 2024	
+Search method	Combination of keywords and MeSH (Medical Subject Headings) terms, both individually and in combination	
+MeSH terms and keywords (combined with AND)	- Perinatal Care [MeSH] OR Prenatal Care [MeSH] OR Postnatal Care [MeSH] OR Peripartum Period [MeSH] OR Antenatal Care [MeSH] OR Pregnancy [MeSH]
+
+- AND Mental Health [MeSH] OR Mental Well-Being OR Psychological Well-Being [MeSH] OR Emotional Well-Being OR Social Well-Being [MeSH] OR Maternal Well-Being [MeSH] OR Hedonic Well-Being OR Eudaimonic Well-Being
+
+	
+Additional terms	Well-Being [MeSH], Quality of Life [MeSH]	
+Exclusion terms	NOT (Paternal [MeSH] OR Foetal Loss [MeSH] OR Contraception [MeSH] OR Abortion, Induced [MeSH])	
+Additional methods	Manual searching of reference lists, dictionaries, thesauri, encyclopaedias, midwifery and psychology journals, mental health literature, and Well-Being textbooks	
+
+To ensure conceptual completeness, additional keyword searches were conducted individually to capture a broad range of studies and definitions related to “Mental Well-Being,” “Well-Being,” and similar concepts. The reference lists of retrieved articles were manually screened for further relevant literature. Grey literature was also consulted, including dictionaries, thesauri, encyclopaedias, midwifery and psychology journals, and Well-Being textbooks. These sources helped define PMWB, identify relevant synonyms, and integrate theoretical perspectives and conceptual frameworks from related disciplines.
+
+Eligibility criteria
+
+Eligibility criteria are summarised in Table 1. Studies were included if they provided a conceptual or theoretical perspective on Perinatal Mental Well-Being (PMWB), Mental Well-Being (MWB), or General Well-Being (GWB), with particular attention to the mental dimension of well-being. Studies were excluded if they focused exclusively on paternal Well-Being, contraception, abortion, or foetal loss. Only peer-reviewed publications in English were considered.
+
+Data extraction and analysis
+
+Data extraction was performed by a single author using a structured form. This form was designed to capture key study elements, such as the study aim, definitions related to PMWB, and participant criteria. The extracted data were then synthesised narratively to construct a detailed profile of PMWB definitions, as reported in the included studies.
+
+Data analysis followed the eight-step concept analysis approach described by Walker and Avant to ensure a systematic exploration of the concept of PMWB [38]. This method provided a comprehension of PMWB through the following steps: selecting the concept, defining the aims of the analysis, exploring its applications, identifying its defining attributes, developing a model case, distinguishing borderline and related cases, determining the concept's antecedents and consequences and finally establishing empirical referents.
+
+Qualitative data analysis using MAXQDA Analytics Pro (version 24.4.1), enhanced this process allowing for coding and categorising data into dimensions and subdimensions.
+
+The analysis utilised the four-step Constant Comparison method. First, relevant excerpts were coded and systematically organised using MAXQDA Analytics Pro software. Second, the data were visualised in tables to facilitate straightforward analysis. Third, similar codes were grouped into subcategories, which were subsequently aggregated into broader categories. Finally, conclusions were drawn to ensure a clear understanding of the attributes of PMWB, as summarised in Tables 2 and 3.
+
+Quality assessment
+
+The methodological quality of the included studies was assessed using the appropriate Joanna Briggs Institute (JBI) Critical Appraisal Tools, tailored to each study design. Where standard tools were not applicable, particularly for conceptual and theoretical contributions, alternative criteria such as clarity of argumentation, theoretical consistency, and relevance to the conceptual aim of the analysis were used. Overall, the included studies demonstrated moderate to high methodological quality. Empirical studies generally met key criteria related to recruitment, measurement, and analysis, while systematic reviews showed sufficient transparency in their search and selection strategies. Conceptual articles were judged to offer substantial theoretical insight and relevance, despite the absence of standardised appraisal frameworks. No articles were excluded based on quality, as the primary criterion for inclusion was their conceptual relevance to the aim of the analysis. A complete overview of the quality appraisal of all included articles is provided in Additional File 2: Quality Appraisal Summary.
+
+Results
+
+Search and screening process
+
+An advanced literature search was conducted, retrieving a total of 2,368 records from the original search strategy, including results from databases such as PubMed, Cochrane, Trip, PsycInfo, Google Scholar, CINAHL, OVID, and Web of Science, as well as through manual searching using reference lists and the snowball method. After removing 424 duplicates, 1,944 records were included for title and abstract screening. Following this screening process, 1,911 records were excluded for not meeting the relevance criteria. Subsequently, 33 full-text articles were assessed for eligibility. Specifically, articles were excluded if they lacked a clear conceptual or theoretical focus on Mental Well-Being or did not provide sufficient detail to support concept analysis. Of these, 13 articles were excluded for failing to meet the inclusion criteria. Ultimately, 20 articles [14, 15, 41–48], [3–5, 20, 21, 23, 49–55] were included in the final analysis. This systematic approach ensured a comprehensive and unbiased review of the topic, as illustrated in Fig. 1.Fig. 1 Screening process flow chart
+
+A detailed overview of the included studies is available in Additional file 1 (see Additional file 1). Among the 20 articles retained for this analysis, four reports from the World Health Organization (WHO, 1946, 2004, 2012, 2018) [3–5, 51] were included as a single entry in Additional file 1 of the included articles. This decision was made to avoid redundancy in reporting, as the WHO reports share consistent themes and a unified emphasis on multidimensional Well-Being. However, during the qualitative coding process, these four reports were treated as separate sources to ensure that their unique contributions and nuanced perspectives were adequately captured in the analysis.
+
+Methodological steps in concept analysis
+
+Step 1: selection of a concept
+
+For this analysis, Perinatal Mental Well-Being (PMWB) was chosen as the focal concept because it plays a pivotal role in the health and Well-Being of both mothers and infants along the continuum of the perinatal period [24]. PMWB addresses maternal mental health challenges during sensitive transitions when both maternal and infant health outcomes are particularly vulnerable [15]. Despite its critical importance, PMWB remains under-researched and lacks a universally accepted definition. The term is often used interchangeably with broader concepts like Mental Well-Being (general concept) or Maternal Health, making it challenging to distinguish its unique dimensions [14, 56]. This ambiguity can hinder healthcare providers’ ability to identify at-risk mothers and design targeted interventions [28, 43, 57].
+
+Clarifying PMWB as a concept plays a crucial role in the advancement of maternal mental health practices [49]. It also supports the development of evidence-based tools and care plans tailored for healthcare professionals, especially midwives and nurses [10, 26, 51]. Moreover, a well-defined conceptual framework helps to foster more holistic approaches to maternal health [27, 30].
+
+Step 2: determine the aims or purposes of the analysis
+
+The primary purpose of this concept analysis is to establish an operational definition of PMWB, providing a foundation for developing reliable measurement tools. Current evidence demonstrates that maternal mental health profoundly impacts prenatal and postnatal outcomes, including infants’ physical, emotional, and cognitive development [6, 7].
+
+This analysis seeks to achieve three main objectives. First, it aims to define the core attributes, antecedents, and consequences of PMWB in order to guide effective interventions [38]. Second, it strives to create a robust framework that healthcare providers, particularly midwives, can apply to enhance maternal care practices [58, 59]. Third, it intends to bridge the gap between research and clinical application by offering practical tools to identify women's needs across the PMWB spectrum [43, 57].
+
+By addressing these aims, midwives and other professionals will be better equipped to identify and support women at risk of poor mental health during the perinatal period, ultimately contributing to improved long-term maternal and child outcomes [58, 59].
+
+Search overview
+
+An advanced literature search across multiple databases and grey literature sources yielded a total of 2,368 records. After removal of duplicates and a two-step screening process (title/abstract and full text), 20 articles were retained for final concept analysis. A detailed overview of this process is presented in the Results section and illustrated in Fig. 1.
+
+Step 3: Identify all uses of the concept
+
+WB is a multidimensional concept that is universally accepted and applied in various domains [60–62]. MWB is a core dimension of the concept GWB. Although not widely used in other areas, PMWB plays a significant role in addressing the mental health issues women experience during the perinatal period [15].
+
+Conceptualisation of women's Perinatal Well-Being indicates that it is simply abstract and multifaceted, entailing self-assessment related to different dimensions of life within the perinatal period itself [15]. Wadephul et al. (2020) conducted a systematic review according to the overarching construct of Perinatal Well-Being (PWB) and reported three key themes [15]. PWB was defined as a subjective experience encompassing physical, affective, and psychological/cognitive dimensions. This suggests that PWB is an entirely individualistic concept because everyone is unique compared to all others. Finally, they viewed PWB as dynamic, evolving due to the influence of modifiable factors during the perinatal period [15].
+
+In midwifery, PMWB is increasingly viewed not only as identifying and managing mental health problems but also as promoting positive mental health outcomes. Traditionally, PMWB focused on preventing and treating conditions like depression and anxiety. However, there is growing emphasis on enhancing PMWB as part of holistic maternity care [63–65]. Midwives play a critical role in this broader strategy by prioritising both maternal and child Well-Being, encompassing physical, emotional psychological, and social dimensions. Continuity of midwifery care fosters trusting relationships, enabling women to share mental health concerns openly and build resilience during the perinatal period [63–65].
+
+Broader definitions of WB, such as the World Health Organization’s, emphasise mental, physical, and social dimensions as centric to overall health [66]. Within this model, PMWB is closely aligned with this consensus and illuminates the need for a comprehensive approach throughout the perinatal period [1, 6]. While PMWB shares conceptual space with the idea of MWB (the general concept), it uniquely includes factors specific to the perinatal period. Included among these factors are changes in hormones, physical health problems linked to the state of being pregnant, and the psychological anticipation of parenthood, which together strengthen maternal mental resilience [6, 15]. It is important to note that PMWB is not static but rather dynamic, changing throughout the perinatal period [66]. Factors like hormonal shifts and varying levels of social support can significantly influence a woman’s mental state during this time.
+
+Additionally, cultural and socio-economic contexts shape how women experience PMWB. For instance, societal expectations and living conditions influence stress levels and access to resources. Addressing these diverse needs requires a context-sensitive approach to PMWB [65].
+
+Step 4: defining attributes of the concept PMWB
+
+Core dimensions of PMWB
+
+PMWB is a dynamic, multifaceted concept that includes a subjective positive self-evaluation across three primary subdimensions:Emotional WB: This dimension includes the ability to experience positive feelings, maintain mood stability, and find life satisfaction and happiness throughout the perinatal period.
+
+Psychological WB: Psychological WB during the perinatal period encompasses a sense of personal growth, autonomy, purpose in life, self-acceptance, all of which are essential as women transition into motherhood.
+
+Social WB: Social WB reflects the mother’s sense of social coherence, integration, and connectedness within her community, as well as a feeling of meaningful contribution and belonging in her social environment during the perinatal period.
+
+Interconnection with other well-being dimensions
+
+PMWB is intricately connected to other dimensions of the broader WB concept, including:Physical WB: The physical health of the mother, including factors such as nutrition, exercise, and the absence of chronic illness.
+
+Spiritual WB: A sense of meaning, purpose, and existential fulfilment, which can be particularly significant during pregnancy and the transition to motherhood.
+
+Economic WB: Financial stability and access to resources that reduce stress and enable better health outcomes.
+
+Ecological WB: The impact of the environment, including access to clean air, water, and safe living conditions.
+
+These dimensions are interrelated and mutually influence one another, contributing to a holistic state of WB during the perinatal period.
+
+Temporal Scope of PMWB
+
+The perinatal period is from conception through 12 months postpartum. This period is marked by significant physical, emotional, psychological, and social changes, crucial for defining and assessing PMWB.
+
+The core dimensions and key elements of PMWB identified in this analysis are presented in Table 2. The analysis provides a detailed breakdown of the qualitative coding process, summarised in Table 3, which quantifies the frequency of explicit (EX), implicit (IM), and not mentioned (NM) codes for the identified attributes. This table builds on the framework presented in Table 2 by offering a quantitative perspective on the core dimensions and their connections to broader Well-Being domains. For instance, Emotional attributes such as ‘Positive Feelings’ and ‘Mood Stability’ are prominently represented, with frequent explicit mentions in the analysed literature. Conversely, dimensions like ‘Social Coherence’ and ‘Ecological Well-Being’, are less emphasised, as evidenced by their relatively low frequency of explicit mentions. Spiritual Well-Being, which captures meaning and existential fulfilment, was explicitly mentioned in only five studies. Economic Well-Being, encompassing financial stability and access to resources, appeared more frequently, with six explicit and ten implicit mentions.
+
+Table 2 presents the conceptual framework of Perinatal Mental Well-Being (PMWB), outlining its core dimensions, antecedents, and consequences. This framework illustrates the interconnections between Emotional, Psychological, and Social Well-Being, while integrating other dimensions of Well-Being. Additionally, the table highlights key attributes and empirical referents, identifying both prominent aspects and gaps in representation, underscoring the need for a holistic approach to PMWB in future research (see Table 2).
+
+Following the conceptual framework outlined in Table 2, a detailed breakdown of the qualitative coding process is presented in Table 3. This table quantifies the frequency of explicit (EX), implicit (IM), and not mentioned (NM) codes for the identified attributes, providing a data-driven perspective on the key dimensions of PMWB (see Table 3).Table 2 Conceptual framework for perinatal mental well-being (PMWB)
+
+Category	Core Dimensions	Key Elements	Description	
+Defining Attributes of PMWB	Emotional Well-Being	• Positive feelings
+
+• Mood stability
+
+• Life satisfaction
+
+• Happiness
+
+	Ability to experience positive emotions, maintain mood stability, and find satisfaction and happiness	
+Psychological Well-Being	• Personal growth
+
+• Autonomy,
+
+• Purpose in life
+
+• Self-acceptance
+
+	Encompasses a sense of personal growth, autonomy, purpose in life, self-acceptance, all essential as women transition into motherhood	
+Social Well-Being	• Connectedness
+
+• Integration
+
+• Social coherence
+
+	Reflects the mother’s sense of social coherence, integration, and connectedness within her community, as well as feeling a meaningful contribution and belonging	
+Integration with other Well-Being Dimensions	Key Elements	
+Antecedents of PMWB	Physical Well-Being	Nutrition, exercise, absence of chronic illness	
+Spiritual Well-Being	Purpose, meaning, existential fulfillment	
+Economic Well-Being	Financial security, access to resources	
+Ecological Well-Being	Safe environment, access to clean air and water	
+Core Dimensions	Key Elements	Description	
+Social Support	Support from family, friends, caregivers	Social support reduces stress and promotes mental Well-Being during the perinatal period	
+Economic Stability	Financial security, access to essential resources	Financial stability reduces stress and ensures access to essential resources	
+Access to Healthcare	Regular prenatal and postnatal care	Healthcare enables early detection and management of mental health concerns	
+Education and Awareness	Knowledge of mental health needs, prenatal classes, early intervention	Education builds skills to manage mental health and enhance resilience	
+Physical Health	Good physical health, absence of chronic conditions	Physical health supports energy, resilience, and Well-Being during the perinatal period	
+Psychosocial Resilience	Coping strategies, resilience, positive outlook	Resilience and coping strategies aid in managing perinatal challenges	
+Cultural and Environmental Factors	Supportive cultural practices, access to green spaces, safe living environment	Supportive culture and environment enhance Perinatal Mental Well-Being	
+Consequences of PMWB	Core Dimensions	Key Elements	Description	
+Mother-Infant Bonding and Child Development	Psychological attachment between mother and child	Strengthens the mother-infant bond, fostering the child’s cognitive, emotional, and social development	
+Impact on Maternal and Infant Health	Reduced mental health risks and better outcomes	Improves maternal mental health and reduces the risk of postnatal depression, leading to healthier outcomes for both mother and child	
+Healthcare Cost Reduction	Efficient resource use	Reduces healthcare costs by minimizing the incidence of mental health issues	
+Stable Family Relationships	Strengthened relationships between partners	Fosters a supportive family environment, reducing relational stress and improving child development	
+Long-Term Resilience	Sustained health and resilience	Builds long-term adaptability and resilience in both mother and child, with benefits for broader public health	
+Empirical Referents	Core Dimensions	Key Elements	Description	
+Capture My Mood (CMM) Scale	Real-time tracking of emotional and psychological states	A self-monitoring tool that correlates with the WEMWBS, useful for tracking Well-Being during the perinatal period	
+Well-Being in Pregnancy (WiP) Questionnaire	Assessment of mental Well-Being during pregnancy	Designed for monitoring mental Well-Being, particularly in women with long-term health conditions	
+Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)	Benchmark Well-Being scale	A validated scale for measuring overall mental Well-Being, commonly used as a benchmark	
+This table presents the perinatal mental Well-Being (PMWB) conceptual framework. It outlines the core dimensions, key elements, and descriptions of PMWB. The interconnection with the other dimensions of the general concept of Perinatal Well-Being is also explained
+
+The table also highlights key antecedents, consequences, and empirical references, providing a structured approach to understanding PMWB and its impact on maternal and child health
+
+The attributes presented in this table were identified through a systematic concept analysis using MAXQDA Analytics Pro, synthesizing 241 codes from 20 articles into key attributes and subdimensions such as Emotional, Psychological, and Social Well-Being, as well as their interconnections with broader Perinatal Mental Well-Being (PMWB) factors
+
+Of the 20 articles retained for this concept analysis, four key documents from the WHO (1946, 2004, 2012, 2018) were coded as separate sources during the qualitative analysis. This approach ensured that the unique contributions of each document were accounted for. However, due to their shared themes and consistent emphasis on multidimensional Well-Being, these documents were later grouped as one entry in the final summary table to avoid redundancy in reporting
+
+Table 3 Summary of attributes and references for perinatal mental well-being coding
+
+Categories	Subcodes	Total EX Explicit Mentions	Total IM Implicit Mentions	Total EX + IM	Total NM Not Mentioned	References EX Explicit Mentions	References IM Implicit Mentions	References NM Not Mentioned	
+Emotional Well-Being	Mood stability	7	14	21	2	[14, 15, 41–45]	[3, 4, 20, 21, 23, 46–54]	[5, 55]	
+	Positive feeling	21	2	23	0	[3–5, 14, 15, 20, 21, 23, 42–50, 52–55]	[3–5, 14, 15, 20, 21, 23, 42–50, 52–55]		
+	Life satisfaction	17	6	23	0	[3, 4, 15, 20, 21, 23, 42, 43, 46–50, 52–55]	[14, 18, 41, 44, 45, 51]		
+	Happiness	17	6	23	0	[4, 15, 20, 21, 23, 42–50, 53–55]	[5, 14, 16, 41, 51, 52]		
+Psychological Well-Being	Personal Growth	8	15	23	0	[3–5, 15, 20, 23, 49, 55]	[14, 21, 41–48, 50–54]		
+	Autonomy	16	5	21	2	[4, 15, 20, 21, 23, 41, 44–49, 52–55]	[3, 5, 42, 43, 50]	[14, 51]	
+	Purpose in life	16	6	22	1	[4, 5, 14, 15, 21, 23, 42–45, 48, 49, 52, 54, 55]	[2, 3, 46, 47, 50, 53]	[51]	
+	Self-acceptance	7	14	21	2	[15, 20, 23, 47–49, 55]	[3–5, 14, 21, 41–45, 50, 52–54]	[46], [51]	
+Social Well-Being	Connectedness	19	4	23	0	[3–5, 14, 15, 20, 21, 23, 41, 44–48, 50, 52–55]	[42, 43, 49, 51]		
+	Integration	5	18	23	0	[3–5, 15, 46]	[14, 20, 21, 23, 41–45, 47–55]		
+	Social coherence	2	9	11	12	[4, 55]	[3, 5, 21, 23, 41, 46, 50, 52, 53]	[14, 15, 20, 42–45, 47–49, 51, 54]	
+Integration with Other Dimensions	Physical Well-Being	19	3	22	1	[4, 5, 15, 20, 21, 23, 43–48, 51–55]	[41, 42, 50],	[49]	
+	Spiritual Well-Being	5	11	16	7	[15, 20, 43, 46, 48]	[3–5, 14, 21, 23, 47, 49, 50, 52, 54]	[41, 42, 44, 45, 51, 53, 55]	
+	Economic Well-Being	6	10	16	7	[3–5, 21, 47, 52]	[14, 15, 20, 23, 44, 45, 48, 50, 53, 54]	[41–43, 46, 49, 51, 55]	
+	Ecological Well-Being	0	6	6	17		[4, 5, 15, 21, 43, 47]	[3, 14, 20, 23, 41, 42, 44–46, 48–55]	
+Multifaceted	Multifaceted	19	2	21	2	[3–5, 14, 15, 20, 21, 23, 41, 42, 44–48, 50, 52–54]	[3, 49]	[51, 55]	
+Dynamic	Dynamic	16	6	22	1	[4, 5, 14, 15, 21, 23, 41, 43–46, 48, 52–55]	[3, 20, 42, 47, 49, 50]	[51]	
+Subjective positive self-evaluation	Positive Self-Reflection	9	13	22	1	[4, 5, 14, 15, 20, 41, 43, 48, 52]	[3, 21, 23, 42, 44–47, 49, 50, 53–55]	[51]	
+EX refers to explicit attributes that were directly mentioned in the analysed texts. IM represents implicit attributes, which were inferred from contextual cues within the texts. The notation (EX + IM) indicates the combined count of both explicit and implicit mentions. NM refers to attributes that were not mentioned in the analysed texts
+
+The attributes presented in this table were identified through a systematic concept analysis using MAXQDA Analytics Pro, synthesizing 241 codes from 20 articles into key attributes and subdimensions such as Emotional, Psychological, and Social Well-Being, as well as their interconnections with broader Perinatal Mental Well-Being (PMWB) factors
+
+Of the 20 articles retained for this concept analysis, four key documents from the WHO (1946, 2004, 2012, 2018) were coded as separate sources during the qualitative analysis. This approach ensured that the unique contributions of each document were accounted for. However, due to their shared themes and consistent emphasis on multidimensional Well-Being, these documents were later grouped as one entry in the final summary table to avoid redundancy in reporting
+
+Step 5: model case
+
+The model case presented in Table 4 was developed based on key findings from the concept analysis.Table 4 Cases analysis of perinatal mental well-being
+
+	Model Case of PMWB	
+Context	Jane is a 30-year-old woman in her third trimester of pregnancy. She is usually in good health, and this is her first pregnancy. Jane is living in a caring place with a partner who is involved in the pregnancy. Her family and friends are very close to her and help her in both mental and practical ways	
+Antecedents	Social Support: Jane’s partner attends prenatal appointments with her. They both participate in a local parent support group where they discuss their experiences with other expectant parents
+
+Economic Stability: Jane and her partner have stable jobs, which allows them to comfortably afford necessary prenatal care, nutrition, and preparation for the baby’s arrival
+
+Access to Healthcare: Jane has regular check-ups with her midwife, who provides comprehensive prenatal care and discusses both Physical and Mental Well-Being with her
+
+Education and Awareness: Jane has participated in prenatal classes where she learned about the and emotional changes during pregnancy, as well as strategies for maintaining Mental Well-Being.
+
+Physical Health: Jane is in good physical health, with no chronic conditions. She maintains a balanced diet and engages in regular exercise to support her pregnancy
+
+Psychosocial Resilience: Jane demonstrates strong psychological resilience by using effective coping strategies and maintaining a positive outlook. She feels confident in her ability to navigate the changes and challenges of the perinatal period
+
+Cultural Factors: Jane feels strengthened by the cultural traditions and rituals surrounding pregnancy in her community, which provide her with additional support during this period.
+
+Ecological Factors: She lives in a safe, green neighbourhood, which helps her relax and enjoy daily walks, contributing to both her Physical and Mental Well-Being
+
+	
+Key Attributes of PMWB	Emotional Well-Being: Jane experiences a range of positive emotions, including excitement and contentment about the impending arrival of her baby. She practices mindfulness and relaxation techniques learned in her prenatal classes. Jane not only experiences joy but also maintains mood stability, which helps her cope with the daily changes and challenges of pregnancy
+
+Psychological Well-Being: Jane is engaged in personal growth as she prepares for motherhood. She feels a strong sense of purpose in her new role and has developed a positive self-identity as a mother-to-be. She accepts the challenges of pregnancy and adapts by using effective coping strategies
+
+Social Well-Being: Jane feels socially connected and supported, both by her immediate family and the broader community. Her relationships are a source of strength, and she actively participates in social networks that provide both emotional and practical support
+
+	
+Consequences	Mother-Infant Bonding:
+
+Jane feels increasingly attached to her baby and looks forward to building a strong bond. Her emotional stability and positive outlook contribute to fostering her baby’s cognitive, emotional, and social development
+
+Impact on Maternal and Infant Health:
+
+Through regular health check-ups and effective coping strategies, Jane reduces her risk of postpartum depression, resulting in improved health outcomes for both her and her baby
+
+Healthcare Cost Reduction:
+
+Jane’s stable physical and Mental Well-Being decreases the need for intensive medical care, leading to more efficient use of healthcare resources
+
+Stable Family Relationships:
+
+Jane’s stable relationship with her partner and the support from her family create a harmonious family dynamic, benefiting both the parents and the child
+
+Long-Term Resilience:
+
+The resilience Jane develops during her pregnancy will help her navigate future challenges as a mother while laying the foundation for her child’s long-term health and Mental Well-Being
+
+	
+	Borderline Case of PMWB	
+Context	Laura is a 28-year-old woman in her second trimester of pregnancy. Although she has a supportive partner, Laura is dealing with high levels of work-related stress. She has a history of anxiety, which has resurfaced during her pregnancy. Laura's physical health is generally good, but her mental health is a concern	
+Antecedents	Social Support
+
+Laura’s partner is supportive, but they both work long hours, limiting their time together. Due to her limited social interactions outside of work, Laura lacks the broader community support that could help alleviate her stress
+
+Economic Stability
+
+Laura and her partner are financially stable, but her demanding job contributes to her stress and anxiety
+
+Access to Healthcare
+
+Laura has regular prenatal visits but feels that her mental health concerns are not fully addressed by her healthcare providers
+
+Education and Awareness
+
+Laura attended prenatal classes, but her anxiety prevents her from fully engaging with the material
+
+Physical Health
+
+Laura’s physical health is generally good; she maintains a balanced diet and does not have any chronic conditions. However, her high stress levels occasionally interfere with her ability to sleep and stay physically active
+
+Psychosocial Resilience
+
+Laura struggles with psychological resilience due to her history of anxiety. Her limited coping mechanisms make it difficult for her to adapt to the stressors of pregnancy, leaving her feeling overwhelmed and less confident in her ability to navigate this period effectively
+
+Cultural and Environmental Factors
+
+Laura’s urban living environment, characterized by limited access to green spaces, further exacerbates her stress levels, as she lacks opportunities for relaxation and physical activity in nature
+
+	
+Key Attributes of PMWB	Emotional Well-Being: Laura struggles with maintaining positive emotions due to her anxiety and work stress. She experiences mood swings and feelings of inadequacy about her ability to be a good mother. Laura's chronic fatigue and lack of physical activity further diminish her ability to cope with the daily stresses of pregnancy, negatively impacting her Mental Well-Being
+
+Psychological Well-Being: Laura’s anxiety interferes with her sense of personal growth and self-acceptance. She often feels overwhelmed and doubts her coping strategies. Despite attending prenatal classes, her anxiety prevents her from fully embracing her new role as a mother, limiting her sense of purpose and fulfilment
+
+Social Well-Being: Although Laura has some social support, her work schedule and anxiety limit her ability to connect with others and participate in social networks
+
+	
+Consequences	Impact on Maternal and Infant Health
+
+Laura’s mental health concerns, if left unaddressed, increase her risk of postpartum depression. Although her physical health is stable, her elevated stress levels and limited resilience may lead to complications, affecting both her and her baby’s overall health outcomes
+
+Healthcare Cost Reduction
+
+Laura’s persistent mental health challenges and high stress could lead to increased reliance on healthcare services, including potential interventions for mental health conditions postpartum. Without targeted PMWB interventions, her situation may result in higher healthcare costs
+
+Stable Family Relationships
+
+While Laura has a supportive partner, the limited time they spend together due to demanding jobs puts a strain on their relationship. The lack of adequate family time and her high stress levels could create relational tensions, potentially impacting the supportive environment needed for her and her baby
+
+Long-Term Resilience
+
+Laura’s low psychological resilience and ongoing anxiety pose challenges for her ability to adapt to motherhood effectively. Without strengthened coping mechanisms and targeted mental health support, her capacity to develop long-term resilience for both herself and her child may remain limited
+
+	
+	Related Case of PMWB	
+Context	Emily is a 32-year-old woman who recently gave birth to her second child. During her pregnancy, she faced several challenges, including the illness of her elderly mother and managing the care of her first child. Despite these challenges, Emily has been able to maintain a generally positive outlook	
+Antecedents	Social Support
+
+Emily has a supportive spouse and extended family who help with childcare and household responsibilities
+
+Economic Stability
+
+Emily and her partner are financially comfortable, allowing her to take maternity leave without financial strain.
+
+Access to Healthcare
+
+Emily received consistent prenatal care, and her healthcare providers were attentive to both her physical and mental health needs
+
+Education and Awareness
+
+Emily is well-informed about the importance of mental health during the perinatal period, having attended support groups and prenatal classes
+
+Physical Health
+
+Emily maintains good physical health, supported by balanced nutrition and regular check-ups during and after pregnancy. However, the physical demands of caring for her newborn and her elderly mother occasionally leave her feeling fatigued, which she manages with rest and practical support from her family
+
+Psychosocial Resilience
+
+Emily demonstrates strong psychosocial resilience by employing various coping strategies to manage stress. She regularly practices mindfulness exercises, which help her stay calm and focused during challenging moments. Her ability to seek and accept help from her partner and family further enhances her capacity to navigate the dual responsibilities of motherhood and caregiving
+
+Cultural and Environmental Factors
+
+Emily’s close-knit cultural community provides her with a strong sense of belonging, which plays a crucial role in supporting her Mental Well-Being during the postpartum period
+
+	
+Key Attributes of PMWB	Emotional Well-Being: Emily experiences a mix of positive emotions, such as love and joy, but also occasional feelings of sadness and stress due to her caregiving responsibilities.
+
+Psychological Well-Being: Emily shows resilience and personal growth as she navigates the challenges of caring for a newborn and her ailing mother. She maintains a sense of purpose in her role as a mother
+
+Social Well-Being: Emily’s strong social network plays a crucial role in maintaining her Mental Well-Being. Her partner takes an active role in parenting and provides emotional support during moments of overwhelm. Furthermore, Emily maintains regular contact with her neighbours and members of her cultural community, who encourage her and offer practical help, such as babysitting services. These social connections provide Emily with a sense of belonging and enable her to maintain a positive outlook, even in challenging times
+
+	
+Consequences	Mother-Infant Bonding and Child Development
+
+Emily’s strong Mental Well-Being enables her to be emotionally available for her children, fostering a secure attachment and positive parent–child relationships. Her proactive involvement in her newborn’s care and the emotional bond she shares with her older child create a nurturing environment that supports her children’s emotional and cognitive development
+
+Impact on Maternal and Infant Health
+
+Emily’s coping strategies and ability to manage stress effectively protect her from developing postpartum depression. This contributes to her overall Well-Being and ensures that she remains physically and mentally healthy, benefiting both her and her newborn. By addressing her mental health needs, Emily avoids potential complications that could impact her caregiving capacity
+
+Healthcare Cost Reduction
+
+Emily’s proactive approach to maintaining her mental and Physical Well-Being reduces the likelihood of requiring intensive healthcare interventions. Her ability to prevent mental health crises contributes to more efficient use of healthcare resources, minimizing costs for both her family and the healthcare system
+
+Stable Family Relationships
+
+Emily’s strong relationship with her spouse and her extended family fosters a supportive and harmonious environment. This stability allows her to balance her caregiving responsibilities and ensures that her children grow up in a positive and emotionally secure family setting. Her ability to manage stress strengthens her relationships and reduces the risk of familial tension
+
+Long-Term Resilience
+
+Emily’s ability to adapt to the demands of motherhood, coupled with her coping strategies and strong social network, builds long-term resilience. This not only benefits her own Mental Well-Being but also sets a positive example for her children, helping them develop emotional adaptability and resilience over time
+
+	
+	Contrasting Case of PMWB	
+Context	Sophie is a 25-year-old woman in her second trimester of pregnancy. Sophie is a single mum who doesn't have a lot of friends and is having a lot of money problems. Her job pays little and doesn't give her regular pregnancy care, and her hours aren't consistent. Sophie experienced sadness in the past, which worsened during her pregnancy	
+Antecedents	Social Support
+
+Sophie lacks a strong support system. She has minimal contact with her family, and her friends are not available to provide consistent help
+
+Economic Stability
+
+Sophie is financially unstable, struggling to afford basic necessities, including healthy food and prenatal care
+
+Access to Healthcare
+
+Due to her financial situation and irregular work hours, Sophie has missed several prenatal appointments and does not have consistent access to healthcare services
+
+Education and Awareness
+
+Sophie has not attended prenatal classes and has limited knowledge about the physical and emotional changes during pregnancy
+
+Physical Health
+
+Sophie’s poor physical health is characterized by inadequate nutrition and persistent fatigue. These issues, exacerbated by financial instability, negatively affect her ability to manage the physical demands of pregnancy
+
+Psychosocial Resilience
+
+Due to her history of depression, Sophie lacks effective coping mechanisms, which makes it challenging for her to handle the stressors of pregnancy. This exacerbates her feelings of hopelessness and emotional detachment
+
+Cultural and Environmental Factors
+
+Living in an overcrowded and noisy environment with limited access to green spaces further reduces Sophie’s ability to find moments of peace, increasing her overall stress levels
+
+	
+Key Attributes of PMWB	Emotional Well-Being:Sophie experiences frequent negative emotions, including sadness, fear, and hopelessness. She has difficulty finding joy in her pregnancy and often feels overwhelmed by her circumstances. Sophie feels isolated and disconnected, with little to no social support. Her limited access to prenatal healthcare prevents her from receiving timely support and interventions, further exacerbating her feelings of stress and anxiety during her pregnancy. As a result, she struggles to find moments of emotional relief.
+
+Psychological Well-Being: Sophie struggles with low self-esteem, a lack of purpose, and persistent feelings of failure. Her history of depression exacerbates these issues, making it difficult for her to cope with the challenges of pregnancy. Sophie's limited access to prenatal healthcare services prevents her from receiving essential guidance and support, which could have alleviated some of her anxiety and stress during pregnancy.
+
+Social Well-Being: Sophie feels isolated and disconnected, with little to no social support. Her lack of social networks contributes to her feelings of loneliness and stress
+
+	
+Consequences	Mother-Infant Bonding and Child Development
+
+Sophie’s persistent sadness, emotional detachment, and lack of joy during pregnancy prevent her from forming a meaningful connection with her baby. This lack of connection may lead to attachment issues in the early stages of her child’s life, potentially affecting the child’s emotional development and Mental Well-Being
+
+Impact on Maternal and Infant Health
+
+Sophie’s poor physical health, including inadequate nutrition and persistent fatigue, exacerbates her feelings of helplessness and deepens her emotional distress. Her pre-existing mental health issues, coupled with financial stress and lack of access to healthcare, place her at a high risk of postpartum depression, which could have lasting effects on both her and her baby’s health
+
+Healthcare Cost Reduction
+
+The absence of adequate prenatal care and her unmet mental health needs may result in increased reliance on healthcare services after childbirth. Without preventive interventions, Sophie’s situation could lead to higher healthcare costs in the long term
+
+Stable Family Relationships
+
+Sophie’s lack of social support and isolation exacerbate her feelings of loneliness and stress. This absence of a supportive partner or family dynamic further reduces her ability to create a stable and nurturing environment for her child
+
+Long-Term Resilience
+
+Without interventions to build her resilience and coping skills, Sophie is likely to continue struggling with depression beyond the perinatal period. This may have a long-term impact on her mental health and reduce her ability to foster a stable and supportive environment for her child, potentially affecting the child’s emotional and Psychological Well-Being
+
+	
+This table presents four case analyses illustrating different manifestations of Perinatal Mental Well-Being (PMWB). The Model Case represents an optimal scenario with strong antecedents and positive consequences, while the Borderline Case demonstrates moderate challenges affecting PMWB. The Related Case highlights resilience despite external stressors, and the Contrasting Case shows significant risk factors that negatively impact PMWB. Each case includes contextual information, antecedents, key attributes, and consequences to illustrate the complexity of PMWB in different maternal experiences
+
+Analysis
+
+This case illustrates a model case with core attributes, antecedents, and consequences of PMWB within the context of a real-life scenario, elucidating the role of social support, economic security, and access to health services. This has significant implications for a holistic conceptualisation of perinatal maternal mental health, demonstrating how optimal support systems can foster positive outcomes for both mothers and children.
+
+Step 6: identifying borderline, related and contrasting case
+
+Borderline and related cases
+
+The borderline case of Laura illustrates a situation in which some aspects of PMWB are present, but defining elements, particularly in Emotional Well-Being, are limited due to a continuous state of anxiety. In contrast, the related case highlights how Emily's narrative demonstrates that strong social support and resilience contribute to maintaining PMWB, even when facing significant challenges.
+
+Analysis
+
+These cases illustrate the complexity of PMWB, where varying combinations of social support, psychological resilience, and economic stability either sustain or exacerbate positive or negative outcomes for mothers and children. The borderline and related cases are used in this analysis to thoroughly assess PMWB and identify its most relevant antecedents and consequences.
+
+Contrasting case
+
+This case highlights the absence of supportive antecedents and its effects on PMWB. It demonstrates how the lack of social support, economic stability, and medical care can severely compromise PMWB during the perinatal period.
+
+Analysis
+
+While the model and related cases illustrate circumstances where PMWB attributes are positively expressed, the contrasting case focuses on situations where these attributes are absent or negatively expressed. This underscores the critical role of supportive antecedents, such as social support and economic stability, in achieving PMWB during the perinatal period. Sophie’s case illustrates how the absence of these antecedents significantly compromises her PMWB. This lack not only affects her PMWB but also hinders her child’s development and disrupts mother-infant attachment. Sophie’s experience highlights the necessity of social support, economic stability, and access to medical care as antecedents for achieving PMWB and preventing adverse outcomes.
+
+A comprehensive summary of the Model, Borderline, Related, and Contrasting Cases of Perinatal Mental Well-Being (PMWB) is provided in Table 4. This table presents key contextual details, antecedents, defining attributes, and consequences for each case. By outlining these cases, the table offers a structured comparison of how different factors influence PMWB outcomes in the perinatal period. For a detailed overview, see Table 4 at the end of this document.
+
+Interconnection with other dimensions of well-being
+
+PMWB is deeply interconnected with other dimensions of the broader Well-Being framework, including Physical, Spiritual, Economic, and Ecological Well-Being. These dimensions interact dynamically, influencing both the mother’s overall health and her PMWB during the perinatal period Table 5.
+
+Table 5 Standard reporting framework for concept analysis according to walker and avant
+
+Step	Title	Description	
+Step 1	Select a concept	Choose a concept that is relevant to your area of study and lacks conceptual clarity	
+Step 2	Determine the aims or purposes of analysis	Define why the concept analysis is being performed and what you hope to achieve	
+Step 3	Identify all uses of the concept	Review the literature to find all uses and definitions of the concept across disciplines	
+Step 4	Determine the defining attributes	Identify core characteristics of the concept that appear repeatedly across sources	
+Step 5	Construct a model case	Develop an example that includes all defining attributes of the concept	
+Step 6	Construct borderline, related, contrary, invented, and illegitimate cases	Create examples that help clarify what the concept is and is not	
+Step 7	Identify antecedents and consequences	Determine what precedes (antecedents) and results from (consequences) the concept	
+Step 8	Define empirical referents	Specify how the concept can be measured or recognized in practice	
+
+For instance, Laura’s borderline case demonstrates how limited access to green spaces (Ecological WB) and work-related stress due to financial instability (Economic WB) exacerbate her anxiety, reducing her Emotional Well-Being. Similarly, Sophie’s contrasting case highlights how poor nutrition and inadequate healthcare access (Physical WB) further diminish her ability to maintain resilience and Psychological Well-Being. In contrast, Emily’s related case illustrates how a supportive cultural environment (Ecological WB) and strong social networks enhance her resilience and enable her to maintain Emotional and Psychological Well-Being, despite significant caregiving challenges.
+
+These cases collectively underscore the importance of addressing interconnected dimensions of Well-Being. By ensuring access to stable resources, supportive environments, and opportunities for meaningful experiences, mothers can achieve a more balanced and holistic state of PMWB.
+
+Step 7: identify antecedents and consequences
+
+Walker and Avant (2011) assert that concept analysis often overlooks or undervalues the establishment of antecedents and outcomes [38]. However, a precise identification can be beneficial in understanding the socio-cultural contexts of the concept's use and its deeper resonances. Antecedents are the conditions necessary for the concept to occur, while consequences are the outcomes of its occurrence.
+
+Major antecedents of PMWB
+
+According to the related literature review, the major antecedents to PMWB are social support [67] economic stability [68], access to healthcare [69], education and awareness [70], physical health [71], and psychosocial resilience [72].
+
+Social support
+
+During the perinatal period, adequate support from family, friends, and providers plays a crucial role in reducing stress and providing both emotional and practical assistance [67].
+
+Economic stability
+
+Financial stability and access to essential resources contribute to higher levels of PMWB by reducing financial pressures and improving access to both healthcare and basic needs [68].
+
+Access to healthcare
+
+Access to regular and available prenatal and postnatal care significantly contributes to early detection and adequate management of disorders, resulting in a better outcome [69].
+
+Education and awareness
+
+Recognition of perinatal mental disorders, supported by educational resources, can also enable individual women to seek care and engage in healthier behaviours both during pregnancy and in the postpartum period [70].
+
+Physical health
+
+The overall physical health status of the mother is another critical determinant of performance, which includes a lack of chronic conditions and good nutritional status [71].
+
+Psychosocial resilience
+
+Psychological resilience, effective coping mechanisms, and a positive outlook are critical psychosocial antecedents that enable women to navigate the perinatal period with adaptive capacity and resolve [72].
+
+Cultural and environmental factors
+
+In addition to the core antecedents identified, cultural and environmental factors, such as societal expectations and safe living conditions, also play a critical role in shaping PMWB. These factors can influence a mother’s stress levels, access to social support, and mental health resilience during the perinatal period [73, 74].
+
+Key Consequences of PMWB
+
+Mother-infant bonding and child development
+
+A positive PMWB boosts the psychological attachment of mothers to their infants, which helps them support their child’s social and cognitive development [1]. Good maternal mental health enhances childhood development characteristics like language, cognitive, and emotional performance [75, 76].
+
+Impact on maternal and infant health
+
+PMWB helps improve perinatal mental health and reduces the risk of mental health problems. [1, 59]. Since PMWB interventions decrease the risk of postnatal depression, it results in better health for the mother and child with less need for healthcare interventions [59].
+
+Healthcare cost reduction
+
+Higher regard for PMWB can help reduce healthcare costs by lowering the incidence and impact of mental health issues, leading to a more efficient use of available resources [77].
+
+Stable family relationships
+
+PMWB strengthens family relationships, particularly between partners, by fostering a stable and supportive environment that benefits both the parents and the child’s development [15, 28]. Strained relationships, however, raise health risks for both mother and child, highlighting the need for support interventions involving both partners [1, 59].
+
+Long-term resilience
+
+The sustained PMWB allows for resilience both in the mother and child; hence, this supports health and PMWB the long term. Overall, PMWB benefits maternal and child health for broader public health by emphasizing its societal importance in general [28].
+
+Step 8. Defining the empirical referents
+
+Establishing empirical references is necessary to adequately conceptualise the identification and measurement of the PMWB concept. Research and clinical practice can demonstrate and measure the concept of PMWB using empirical referents [38]. Empirical referents allow abstract ideas like PMWB to be operationalised as observable and measurable parts. This step is crucial for verifying the accuracy of PMWB measures and establishing a strong basis for creating interventions that support maternal mental health during the perinatal period [38].
+
+Empirical tools for measuring PMWB
+
+The"Capture My Mood"(CMM) enables women to self-monitor PMWB by tracking their emotional and psychological states in real-time throughout the perinatal period [41]. The CMM scale enables self-assessment for early detection of mental health problems, facilitating timely support and interventions by healthcare providers. The CMM scale has shown a strong correlation with the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a validated tool for assessing General Mental Well-Being across all life stages [78]. This correlation validates the reliability of the CMM scale and allows PMWB estimates to be benchmarked against established tools like the WEMWBS.
+
+Building on the insights from the CMM scale, the Well-Being in Pregnancy (WiP) questionnaire has also been validated as a key tool for PMWB assessment [57]. Researchers refined the WiP questionnaire through cognitive interviews and psychometric validation, which ensures its relevance and accuracy in assessing pregnant women's PMWB [57]. It is a multifunctioning tool, combining GWB items and specific questions relevant to the challenges experienced by women in pregnancy, making it versatile for both clinical and research applications [57].
+
+Practical applications
+
+Women who used the CMM tool reported it to be easy, user-friendly, and especially useful at an early postnatal period [41]. The combined use of the CMM scale and WiP questionnaire, alongside standard measures like WEMWBS, facilitates a multi-dimensional approach to PMWB. These empirical referents are essential in providing timely support to women during the perinatal period, ultimately enhancing maternal and infant health outcomes.
+
+Discussion
+
+The concept analysis of PMWB provides a deeper view of the multidimensional nature of maternal mental health throughout the perinatal period and identifies Emotional, Psychological, and Social WB as core components. Each core dimension contributes uniquely to the overall framework of PMWB, yet they are deeply interconnected.
+
+Emotional Well-Being encompasses the ability to experience positive feelings, maintain mood stability, and derive life satisfaction and happiness throughout the perinatal period. This dimension is particularly influenced by hormonal changes, physical health, and the presence of supportive relationships, which can either buffer or exacerbate emotional challenges.
+
+Psychological Well-Being reflects a deeper sense of personal growth, autonomy, self-acceptance, and purpose in life. These qualities are essential for women as they navigate the significant role transitions and identity shifts associated with motherhood. Developing psychological resilience and fostering a strong sense of mastery can help women adapt more effectively to the demands of the perinatal period.
+
+Social Well-Being encompasses the mother’s sense of social coherence, integration, and connectedness within her community. It also involves feelings of meaningful contribution and belonging in her social environment. Social support networks, including family, friends, and healthcare providers, are vital for reinforcing this dimension, as they help women feel valued and reduce feelings of isolation or stress.
+
+Together, these three core components form the foundation of the Mental dimension in the perinatal period, with changes in one domain often influencing the others. For instance, a lack of social support can negatively impact emotional stability and undermine a woman’s sense of self-efficacy and purpose. By addressing these dimensions holistically, PMWB can be more effectively supported and optimized throughout the perinatal period.
+
+Considering these Mental dimensions, the analysis underlines that PMWB cannot be viewed outside broader conceptualisations of WB, including Physical, Spiritual, Economic, and Ecological factors. The interrelationship between various dimensions highlights that changes in one domain can significantly influence outcomes in others. These findings align with previous studies that established the importance of a holistic approach in maternal health practices [15, 56]. It is also crucial to recognize that PMWB is a dynamic concept characterized by subjective positive self-evaluation and fluctuations throughout the perinatal period. For example, hormonal changes and physical discomfort may vary across different stages of pregnancy, while psychological factors like fear of childbirth, role transitions, and evolving social support systems can dynamically influence a woman's mental state [6, 66, 69, 79] Additionally, PMWB is a dynamic concept, influenced by the cultural and social environment in which women live and experience their Mental Well-Being throughout the perinatal period [67, 73, 74].
+
+Implications for midwifery and maternal healthcare
+
+One important finding of this study is the critical role midwives and other healthcare providers play in identifying and supporting PMWB. Midwives hold an important position in offering psychosocial, integrated support through routine care because they can often remain in close, trusted contact with women throughout the perinatal period [28]. At the same time, Howard et al. (2014) emphasize the critical importance of integrating mental health support into perinatal care, which includes enhancing midwifery education to improve support for PMWB [1].
+
+In addition to using screening tools to identify PMWB concerns, midwives can play a proactive role in enhancing maternal resilience, which has been shown to buffer stress and improve coping mechanisms during the perinatal period. Strategies such as promoting stress management techniques, facilitating access to peer support groups, and encouraging self-care practices can help build maternal resilience [80]. For instance, interventions such as mindfulness-based stress reduction programs, psychoeducation sessions, and structured peer support initiatives have been identified as effective approaches for enhancing maternal resilience and reducing stress during the perinatal period [81, 82]. This aligns with findings from Van Haeken et al. (2023), who developed a systematic resilience-enhancing intervention framework informed by the Behaviour Change Wheel [83]. This approach emphasizes the importance of measurement in guiding tailored interventions aimed at enhancing resilience during the perinatal period [83]. Moreover, the findings of Van Haeken et al. (2020) highlight that strengthening resilience through attributes such as social support, self-efficacy, self-esteem, a sense of mastery and positive personality traits can significantly enhance PMWB [84]. These attributes align closely with the core dimensions of PMWB identified in this study: Emotional, Psychological, and Social Well-Being. Social support contributes to Social Well-Being by fostering connectedness and reducing isolation, while self-efficacy and self-esteem strengthen Psychological Well-Being by promoting autonomy, self-acceptance, and personal growth. Additionally, optimism and other positive personality traits help sustain Emotional Well-Being by enhancing emotional stability and fostering positive feelings [84].
+
+By focusing on these attributes, midwives can adopt a resilience-enhancing approach, reinforcing both Psychological Emotional and Social Well-Being in women during the perinatal period. These strategies not only mitigate stress but also foster a sense of personal growth and adaptation, underscoring the interconnected and holistic nature of PMWB [84].
+
+Challenges in defining and measuring PMWB
+
+Challenges in Defining and Measuring PMWB Empirical referents such as the Capture My Mood (CMM) scale and the Well-Being in Pregnancy (WiP) questionnaire provide a foundation that enables the quantification of PMWB. However, challenges remain, particularly toward arriving at universally valid and reliable measures across diverse cultural and socioeconomic contexts [41]. Women using the CMM scale reported it as easy to use and particularly helpful in the early days after birth when mental health support is most needed [78]. The high correlation between the CMM scale and the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) validates the reliability of the CMM scale, allowing PMWB estimates to be benchmarked against an established and widely recognized tool for assessing general Mental Well-Being [78, 85].
+
+The current validation studies for the CMM and WiP tools are primarily based on homogeneous or Western populations, limiting their generalizability and their applicability in culturally diverse settings where understandings of mental health and Well-Being may differ [41, 57, 73]. Therefore, these tools need further research to establish their validity across various cultural and socio-economic settings and the ability of their accurate linking with the subtlety of PMWB [69].
+
+Furthermore, PMWB deeply embedded in cultural understandings of motherhood, emotional expression, and social support. Studies have shown that cultural norms influence not only how symptoms of distress are experienced and expressed, but also how they are recognised and addressed by health professionals [7, 73, 86]. For instance, perceptions of what constitutes “Well-Being” may vary significantly across populations, with some cultures emphasising emotional restraint or collective responsibility over individual psychological flourishing [87]. As a result, tools developed and validated in predominantly Western contexts may fail to capture culturally nuanced manifestations of PMWB, potentially leading to under-identification or misclassification of mental health needs. This underscores the importance of culturally sensitive frameworks and the cross-cultural validation of measurement instruments in future research [7, 73, 86, 87].
+
+Critical reflections
+
+This analysis reveals that while Emotional, Psychological, and Social are well represented in maternal health frameworks, dimensions like Spiritual, Economic and Ecological Well-Being are often overlooked. For instance, Social Coherence, which reflects the sense of community and mutual trust, was explicitly mentioned in only two studies, while Ecological Well-Being had no explicit mention. These findings suggest that these dimensions are often overlooked in the literature, potentially limiting the holistic understanding of PMWB. Addressing these gaps in future research is crucial to ensure a comprehensive approach to maternal mental health.
+
+Additionally, since limited PMWB-specific studies are currently available, this review had to draw insights from studies focused on GWB. While such studies had useful insights, it also meant there was variability in scope and focus, complicating any direct comparisons and generalizability of findings to the perinatal period specifically. However, given the ongoing evolution of PMWB concepts, future research must clarify PMWB's unique attributes to distinguish it from broader mental health constructs [12].
+
+Finally, there is the assumption in much of the literature that PMWB can be universally defined and measured, when in fact it is most likely that different perinatal populations experience and interpret PMWB uniquely. For example, the economic stability component of PMWB may be experienced in low-resource settings quite differently compared to high-income contexts, where different aspects of PMWB might be weighted more by women due to varying levels of resources and social support [1]. This analysis underscores that a comprehensive understanding of PMWB cannot be separated from the cultural context in which women live. Without acknowledging cultural diversity, important aspects of PMWB, such as traditional postpartum practices or the stigma surrounding mental health; may remain overlooked [67, 73, 74].
+
+Future directions
+
+Future research should prioritize the inclusion of underrepresented dimensions such as Spiritual, Economic and Ecological Well-Being. Exploring how these dimensions interact with core components like Emotional, Psychological, and Social Well-Being could provide a fuller understanding of PMWB. Moreover, investigating these dimensions would help address the current gaps in the literature and ensure a more comprehensive and inclusive approach to maternal mental health.
+
+Future research should be directed to the construction of valid and culturally sensitive tools and methods to accommodate the diversity of perinatal populations [57, 73, 88]. Concomitantly, advancing the field of digital health, new modalities such as telemedicine and mobile applications offer novel opportunities for real-time mood tracking, thus enabling continuous support for PMWB. These can ensure that mental health challenges, when arising, will be timely addressed, through instantaneous feedback and, thereby, early intervention along with other advantages [89]. Digital interventions, in particular, in low-resource settings could contribute to the closing of critical gaps in maternal mental health care, where conventional services are usually limited because of resource constraints [28, 77]​. By incorporating digital health solutions, maternal mental health support can become more accessible, responsive, and tailored to individual needs, ultimately enhancing PMWB outcomes on a broader scale.
+
+These findings have important consequences for clinical practice. The key attributes and antecedents of PMWB identified in this analysis can guide the development of more holistic screening methods. These should focus not only on risks, but also on strengths. Midwives and other maternity care providers could benefit from practical tools and training. These should cover both protective and promotive aspects of Mental Well-Being.
+
+The focus on conception as a starting point also underlines the need for earlier psychosocial support. Ideally, this support begins even before pregnancy, or at least in the very early stages. PMWB is shaped by both cultural and personal factors. Therefore, clinical interventions must be flexible and culturally sensitive. By applying these insights in daily care, early detection may improve. At the same time, maternal support systems can be strengthened, leading to better long-term outcomes for mothers and their children.
+
+This study consequently provides a clearer conceptualisation of PMWB, recognizing its importance in both maternal and child health. Application of this framework to clinical service will thus ensure better maternal mental health outcomes, ultimately benefiting families and communities. The adequately resourced holistic approach to PMWB and practical assessment greatly holds promise to transform maternal mental health care in the perinatal period.
+
+Strengths and limitations
+
+It represents the first review of concepts related to PMWB during pregnancy, childbirth, and up to one year after birth. In this sense, it makes a new contribution to research on maternal mental health. This analysis puts forward Emotional, Psychological, and Social Well-Being as core dimensions, integrating broader factors such as Physical, Spiritual, Economic, and Ecological Well-Being for a comprehensive and holistic framework in understanding PMWB. This constitutes a fundamental strength since the basis of further research and practical interventions is constituted thereby.
+
+A critical limitation is the reliance on studies focused on general WB or MWB rather than specifically on PMWB. While these studies added value by illuminating the mental aspects of PMWB, they introduced variability in scope and content, complicating direct comparisons and highlighting the need for research directly addressing PMWB.
+
+The diverse composition of the research team including mothers, fathers, midwives, nurses, and a psychologist is at once considered both a factor of their strength and potential limitations. While such personal and professional experiences enriched the analysis by bringing multiple perspectives, they may equally introduce interpretive bias. A similar analysis conducted by another, or more diverse research team could consider other perspectives and provide validation of the findings presented here.
+
+The abstract nature of this analysis also places limitations in terms of applicability to empirical practice. This provides a framework for tool and intervention development based on further validation that can be extrapolated to measurable and actionable frameworks, particularly across different cultural and socioeconomic statuses.
+
+Conclusion
+
+PMWB is a dynamic and multifaceted concept that encompasses a subjective positive self-evaluation across three primary dimensions: Emotional, Psychological, and Social WB. Emotional WB includes elements such as positive emotions, life satisfaction, mood stability and happiness. Psychological WB encompasses personal growth, autonomy, purpose in life, self-acceptance, and self-esteem. Social WB involves social coherence, social integration, connectedness, and social contribution.
+
+This analysis highlights the interconnectedness between PMWB and broader dimensions of General Well-Being, including Physical, Spiritual, Economic, and Ecological aspects. Recognizing the reciprocal influence among these factors is essential, as a woman's PMWB is likely to evolve dynamically throughout the perinatal period in response to the ongoing development of parenthood.
+
+Based on the attributes identified in this concept analysis, we propose the development of a culturally sensitive scale for women to self-monitor their PMWB. This scale is intended to alert women to changes in their mental status, facilitating timely support and interventions that can enhance maternal mental health throughout the perinatal period. Future research should focus on validating such a scale across diverse populations and developing targeted interventions that address the multidimensional nature of PMWB. This framework not only enhances maternal mental health care but also contributes to improved health outcomes for families and communities by promoting holistic and dynamic approaches to perinatal care and recognizing mental health as a core element of overall maternal Well-Being.
+
+Supplementary Information
+
+Supplementary Material 1.
+
+Supplementary Material 2.
+
+Abbreviations
+
+PMWB Perinatal Mental Well-Being
+
+PWB Perinatal Well-Being
+
+GWB General Well-Being
+
+MWB Mental Well-Being
+
+WB Well-Being
+
+Acknowledgment
+
+Not applicable
+
+Authors’ contributions
+
+M.M. conceptualized the study and conducted the literature review. M.M., E.F., and O.T. developed the methodological framework. M.M. contributed to the qualitative analysis and coding process. O.T. and E.F. supervised the study. M.M. wrote the main manuscript draft, and all authors (M.M., E.F., S.V.H., A.B., and O.T.) reviewed and approved the final manuscript.
+
+Funding
+
+This research received no specific grant from any funding agency.
+
+Data availability
+
+All data generated or analysed during this study are included in this published article and its supplementary files.
+
+Declarations
+
+Ethics approval and consent to participate
+
+This study is based on a conceptual analysis of existing literature and did not involve human participants; hence no ethical approval was required.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+Bedaso A, Adams J, Peng W, Sibbritt D. The relationship between social support and mental health problems during pregnancy: a systematic review and meta-analysis. Reprod Health. 2021;18(1):162.34321040 10.1186/s12978-021-01209-5 PMC8320195
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+Margiotta C, Gao J, O’Neil S, Vohra D, Zivin K. The economic impact of untreated maternal mental health conditions in Texas. BMC Pregnancy Childbirth. 2022;22(1):700.36096759 10.1186/s12884-022-05001-6 PMC9464607
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+Webb R, Uddin N, Constantinou G, Ford E, Easter A, Shakespeare J, et al. Meta-review of the barriers and facilitators to women accessing perinatal mental healthcare. BMJ Open. 2023;13(7):e066703.37474171 10.1136/bmjopen-2022-066703 PMC10360426
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+Noonan M, Doody O, Jomeen J. Midwifery and Perinatal Mental Health. In: Borg Xuereb R, Jomeen J, editors. Perspectives on Midwifery and Parenthood. Cham: Springer International Publishing; 2022. p. 51–66.
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+Brown HK, Wilton AS, Ray JG, Dennis C-L, Guttmann A, Vigod SN. Chronic physical conditions and risk for perinatal mental illness: a population-based retrospective cohort study. PLoS Med. 2019;16(8):e1002864.31449518 10.1371/journal.pmed.1002864 PMC6709891
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+Laurenzi CA, Gordon S, Abrahams N, Du Toit S, Bradshaw M, Brand A, et al. Psychosocial interventions targeting mental health in pregnant adolescents and adolescent parents: a systematic review. Reprod Health. 2020;17:1–15.32410710 10.1186/s12978-020-00913-y PMC7227359
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+Liu Y, Kaaya S, Chai J, McCoy DC, Surkan PJ, Black MM, et al. Maternal depressive symptoms and early childhood cognitive development: a meta-analysis. Psychol Med. 2017;47(4):680–9.27834159 10.1017/S003329171600283X
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+Hajure M, Alemu SS, Abdu Z, Tesfaye GM, Workneh YA, Dule A, et al. Resilience and mental health among perinatal women: a systematic review. Front Psych. 2024;15:1373083.10.3389/fpsyt.2024.1373083 PMC11298415 39104881
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diff --git a/corpus/healthcare/text/9d75dc4cfe0ebd38.txt b/corpus/healthcare/text/9d75dc4cfe0ebd38.txt
new file mode 100644
index 0000000000000000000000000000000000000000..fa8bfbbe7b595c977fb8ea7e7218b02fa324cd08
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@@ -0,0 +1,593 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Rev Esc Enferm USP
+Journal ID: Rev Esc Enferm USP
+NLM Journal ID: 0242726
+Journal ID: reeusp
+
+Revista da Escola de Enfermagem da USP
+
+ISSN: 0080-6234
+EISSN: 1980-220X
+Publisher: Escola de Enfermagem da Universidade de São Paulo
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13138794
+PMID: 42081669
+DOI: 10.1590/1980-220X-REEUSP-2025-0386en
+Article ID: 00441
+Article version: 1
+Subjects: Original Article
+
+Lexical analysis of terms related to nursing care for pregnant women with syphilis
+
+https://orcid.org/0000-0001-8339-6482 da Silva Ana Beatriz Pereira 1
+https://orcid.org/0000-0001-6290-9365 da Silva Richardson Augusto Rosendo 2
+https://orcid.org/0000-0002-6372-8424 de Medeiros Jocellem Alves 1
+https://orcid.org/0009-0000-0646-2669 de Queiroz José Leonildo Fernandes 1
+https://orcid.org/0009-0003-5462-5970 Silva Vitória de Araújo e 2
+https://orcid.org/0000-0002-8782-535X Sales Amanda de Brito Rangel Pereira 1
+https://orcid.org/0009-0005-6148-0575 Galon Jéssica Fernanda 3
+https://orcid.org/0000-0002-2856-8525 Felix Elise Cristina dos Santos 2
+1 Universidade Federal do Rio Grande do Norte, Programa de Pós-Graduação em Enfermagem, Natal, RN, Brazil.
+2 Universidade Federal do Rio Grande do Norte, Departamento de Enfermagem, Natal, RN, Brazil.
+3 Universidade de Ribeirão Preto, Departamento de Enfermagem, Ribeirão Preto, SP, Brazil.
+Corresponding author: Ana Beatriz Pereira da Silva Avenida Senador Salgado Filho, s/n, Lagoa Nova 59078-970 – Natal, RN, Brazil biapeci@gmail.com ASSOCIATE EDITOR: Marcia Regina Cubas
+
+Electronic publication date: 2026 May 1
+Publication date: 2026
+Volume: 60
+Electronic Location ID: e20250386
+Received 2025 Aug 29; Accepted 2026 Feb 28
+License: This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Syphilis, Pregnant People, Nursing Care, Prenatal Care, Standardized Nursing Terminology
+Figure count: 12
+Table count: 03
+Reference count: 27
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Objective:
+
+To analyze the lexicon related to nursing care for pregnant women with syphilis, based on the scientific literature.
+
+Method:
+
+A scoping review conducted according to the framework proposed by Arksey and O’Malley and the PRISMA-ScR guidelines. Searches were performed in national and international databases (PubMed, CINAHL, Web of Science, LILACS, SciELO, CAPES Theses and Dissertations Portal, Open Access Scientific Repository of Portugal – RCAAP, National ETD Portal, and Theses Canada), with no restrictions on language or year. Primary studies and gray literature available in full text that addressed the study objective were included; editorials, opinion pieces, and reviews were excluded. The selected studies were submitted to lexical analysis using the IRaMuTeQ software, supported by Roy’s Adaptation Theory.
+
+Results:
+
+A total of 10,875 records were identified, of which only 11 met the study objective and comprised the final corpus, totaling 641 segments analyzed. Seven classes emerged: Policy and Access; Management and Service; Community Network; Reception and Bond; Maternal-Child Care; Early Detection; and Diagnosis and Treatment. These categories highlight the complexity and interdependence among the clinical, social, and organizational dimensions of care.
+
+Conclusion:
+
+Lexical analysis revealed a representative vocabulary for nursing care of pregnant women with syphilis.
+
+INTRODUCTION
+
+Syphilis during pregnancy constitutes a significant public health problem in Brazil, primarily due to its high rate of vertical transmission and severe maternal and perinatal repercussions(1,2). Caring for pregnant women diagnosed with syphilis requires a comprehensive, systematic, and evidence-based approach.
+
+In this context, nurses stand out as key professionals responsible for implementing care, surveillance, and health promotion actions(3,4). Within nursing consultations and other care practices, the use of standardized and technically precise language is essential to ensure continuity and quality of care(5).
+
+However, in clinical practice, significant gaps remain in the use and documentation of terms related to the care of pregnant women with syphilis, which compromises the systematization of actions and multiprofessional communication. Moreover, concepts found in the scientific literature are not always analyzed in an integrated manner, hindering their incorporation into standardized language systems such as ICNP®(6).
+
+Lexical analysis of scientific texts enables the identification of the most recurrent concepts on the subject, revealing beliefs, practices, and dimensions of care through the lens of nursing academic discourse(7). In this regard, lexicography provides a theoretical and methodological foundation for analyzing language in use, allowing not only the identification of relevant terms but also the understanding of how they reflect consolidated knowledge. By employing tools such as Descending Hierarchical Classification (DHC), it is possible to highlight semantic cores and organize them into thematic classes that represent everyday practice(8).
+
+In nursing, lexical analysis emerges as a promising strategy to understand complex phenomena such as syphilis in pregnancy. Organizing the terms that compose this field contributes to the construction of more representative terminological subsets, facilitating their incorporation into classificatory systems and promoting the standardization of language in clinical records(9).
+
+Given this, the following question arises: how are the terms related to nursing care for pregnant women with syphilis lexically organized in the scientific literature? Thus, the objective of this study was to analyze the lexicon related to nursing care for pregnant women with syphilis, based on the literature in the field.
+
+METHOD
+
+Study Design
+
+This study is a scoping review, guided by a research protocol previously registered in the Open Science Framework (https://osf.io/cs2pe/), and conducted in accordance with the recommendations of the Joanna Briggs Institute Reviewer’s Manual and the PRISMA-ScR guidelines(10). The review followed the methodological framework proposed by Arksey and O’Malley(11), comprising the stages of research question identification, study selection, mapping and data extraction, and narrative synthesis of findings.
+
+The guiding question was constructed using the PCC strategy, defined as: P (Population) – pregnant women with syphilis; C (Concept) – nursing care; C (Context) – prenatal follow-up. Accordingly, the following research question was established: What nursing care is directed toward pregnant women with syphilis?
+
+Study Setting
+
+Searches were conducted in electronic databases and gray literature repositories, accessed through the CAPES Journal Portal via the Federated Academic Community (CAFe).
+
+Population and Selection Criteria
+
+Publications aligned with the study objective and available in full text through the CAPES Portal were included, encompassing gray literature (theses, dissertations, and technical documents), with no restrictions on year or language. Editorials, letters to the editor, opinion articles, theoretical essays, and narrative, integrative, systematic, and scoping reviews were excluded.
+
+Data Collection
+
+Study identification occurred in three phases:
+
+Indexed databases: PubMed/MEDLINE, CINAHL, Web of Science, LILACS, and SciELO.
+
+Gray literature: CAPES Theses and Dissertations Portal, Open Access Scientific Repository of Portugal (RCAAP), National ETD Portal, Theses Canada, and documents from the Brazilian Ministry of Health.
+
+Manual search: reference lists of included studies to identify evidence not initially retrieved.
+
+Searches were updated in February 2025 and structured using indexed descriptors (MeSH/DeCS) and free terms, combined with Boolean operators AND and OR, adapted to each database. Main search terms included: “Syphilis,” “Syphilis, Congenital,” “Pregnant Women,” “Pregnancy,” “Prenatal Care,” “Prenatal Diagnosis,” “Nursing,” “Nursing Care,” as well as free terms such as “gestational syphilis,” “maternal syphilis,” “antenatal care,” “prenatal follow-up,” “nurse,” “nursing interventions,” “cuidado de enfermagem,” and “pré-natal.”
+
+Study selection was performed using the Rayyan – Intelligent Systematic Review software (https://rayyan.ai/). Two researchers independently analyzed titles and abstracts; eligible studies were read in full. Disagreements were resolved by a third researcher, and duplicates were considered only once.
+
+Data extraction was conducted by two researchers using a structured instrument in Microsoft Excel 2019®, with disagreements resolved by consensus. The instrument included: study identification (title, authors, year, journal, country, language), methodological aspects (design, sample size), main results, and conclusions.
+
+Data Analysis and Processing
+
+Studies were classified according to the level of evidence of the Oxford Centre for Evidence-Based Medicine (OCEBM), ranging from systematic reviews of randomized clinical trials (level 1a) to expert opinion (level 5), and according to the JBI classification (levels 1 to 4). A textual corpus was constructed using excerpts from abstracts, results, and final considerations (excluding references), compiled into a single file in Microsoft Word and submitted to IRaMuTeQ.
+
+Lexical analysis employed Descending Hierarchical Classification (DHC) and Correspondence Factor Analysis (CFA), segmenting the text into context units and grouping segments by lexical and statistical similarity. Interpretation and categorization of terms followed Roy’s Adaptation Theory, organizing data into the physiological-functional, self-concept– identity, role performance, and interdependence modes.
+
+Results were presented through the PRISMA-ScR flowchart (identification, screening, eligibility, and inclusion), tables with methodological characteristics and main findings, charts summarizing levels of evidence and search strategies, and figures generated by IRaMuTeQ (DHC dendrogram and CFA factorial map).
+
+Ethical Considerations
+
+As this study is a literature review using secondary data from public domain sources, approval by a Research Ethics Committee was not required. Copyright and reference accuracy were respected throughout the process.
+
+RESULTS
+
+The review process began with the identification of 10,879 records across different databases and manual sources. Most of these records were retrieved from PubMed (n = 10,006), followed by Web of Science (n = 350), SciELO (n = 255), CAPES Journal Portal (n = 133), Cochrane (n = 61), LILACS (n = 60), and RCAAP (n = 6). In addition, four manuals/protocols from the Brazilian Ministry of Health were identified.
+
+During the screening stage, 5,219 records were excluded for not meeting eligibility criteria, duplication, or irretrievability. Consequently, 5,656 studies were analyzed by title and abstract, resulting in the exclusion of 5,406 records due to thematic irrelevance or failure to address the guiding question.
+
+A total of 250 studies proceeded to full-text eligibility assessment. After complete reading, 241 studies were excluded. In parallel, of the four reports/manuals evaluated through complementary methods, two were deemed ineligible. At the end of the selection process, 11 studies (nine articles and two reports/manuals) were included in the final sample of this review (Figure 1).
+
+Figure 1 Flowchart of the study selection process. Natal, RN, Brazil, 2025.
+
+The final textual corpus of the study consisted of 11 documents, presented in Chart 1, which were processed and segmented into 641 text segments (TSs). All segments were considered valid for lexical analysis, resulting in full utilization (100%).
+
+Chart 1 Selected studies. Natal, RN, Brazil, 2025.
+
+Study	Country (Year)	Type of Publication/Type of Study/Level of Evidence	
+E1(12)	Brazil (2020)	Article/Qualitative, descriptive/Level of Evidence 4	
+E2(13)	Brazil (2019)	Article/Quantitative, descriptive and exploratory/Level of Evidence 4	
+E3(14)	Brazil (2019)	Article/Quantitative, descriptive and exploratory/Level of Evidence 4	
+E4(15)	Brazil (2022)	Article/Qualitative, descriptive and exploratory/Level of Evidence 4	
+E5(16)	Brazil (2021)	Article/Qualitative, descriptive/Level of Evidence 4	
+E6(17)	Mozambique (2000)	Article/Qualitative, descriptive/Level of Evidence 2c	
+E7(18)	Brazil (2020)	Article/Qualitative, action research/Level of Evidence 2c	
+E8(19)	United States (1992)	Article/Narrative descriptive review/Level of Evidence 5	
+E9(20)	United Kingdom (1998)	Article/Narrative descriptive review/Level of Evidence 5	
+E10(21)	Brazil (2007)	Technical Manual/N/A/Not specified	
+E11(22)	Brazil (2016)	Technical Manual/N/A/Not specified	
+
+After data analysis, the results were organized and presented in tables. To facilitate understanding and visualization, the studies were identified by the letter “E” (study), followed by sequential Arabic numerals (1, 2, 3, … 11), resulting in the codes E1, E2, E3, … E11.
+
+The analysis conducted using the IRaMuTeQ software allowed the classification of the segments into seven distinct thematic classes. To ensure terminological uniformity, the classes were named in the singular and standardized as follows: Class 1 – Policy and Access (16.22%); Class 2 – Management and Service (13.51%); Class 3 – Community Network (13.51%); Class 4 – Reception and Bond (13.51%); Class 5 – Maternal-Child Care (16.22%); Class 6 – Early Detection (13.51%); and Class 7 – Diagnosis and Treatment (13.51%), as shown in Figure 2.
+
+Figure 2 Diagram of the classes included in the dendrogram of the textual corpus from the manuscripts in the sample. Natal, RN, Brazil, 2025.
+
+These classes do not operate in isolation; rather, they represent the trajectory of nursing care, which begins with structural conditions (Classes 1 and 2), progresses through interpersonal relationships (Classes 3 and 4), and culminates in direct clinical intervention (Classes 6 and 7).
+
+The relationship among the classes should be interpreted from left to right. Initially, the corpus was divided in the first iteration, separating Class 1 from the others. In the second iteration, the remaining subcorpus was subdivided into two, giving rise to Class 2 and another subcorpus. In the third iteration, this latter subcorpus was again divided, generating Class 5 on one side and a new subcorpus that, in the fourth iteration, produced Classes 3 and 4. The descending hierarchical classification was interrupted at this point, as the five classes demonstrated stability, meaning they were composed of text segments with internally homogeneous vocabulary.
+
+The Correspondence Factor Analysis (CFA) mapped the spatial distribution of the classes (Figure 3). The identified classes are directly articulated with nursing clinical practice, as they translate essential dimensions of care for pregnant women with syphilis.
+
+Figure 3 Correspondence Factor Analysis of the most frequent words in each lexical class, based on hierarchical classification. Natal, RN, Brazil, 2025.
+
+Lexical findings reveal that policy and management (Classes 1 and 2) impact service organization and guarantee access to prenatal care, while community network and bond (Classes 3 and 4) reinforce the importance of qualified listening and trust for adherence to treatment and partner tracing. Meanwhile, maternal-child care and early detection (Classes 5 and 6) highlight the need for integrated actions to ensure prevention of vertical transmission. In turn, diagnosis and treatment (Class 7) emphasize the technical dimension which, when dissociated from the others, may fragment care.
+
+Thus, lexical analysis strengthens the link between scientific discourse and clinical practice, providing support for nurses to align technical interventions with the relational and organizational dimensions of care.
+
+In Figure 4, the words extracted from the corpus were correlated with the adaptive modes of Roy’s Adaptation Theory. The visualization confirms that nursing care for pregnant women with syphilis is multidimensional: technical terms are articulated with social support terms, demonstrating that effective adaptation depends both on the nurse’s clinical competence (diagnosis and treatment) and on their ability to coordinate the care network and provide reception.
+
+Figure 4 Terms related to nursing care for pregnant women with syphilis in light of Roy’s Adaptation Theory. Natal, RN, Brazil.
+
+The Correspondence Factor Analysis (CFA) revealed the semantic and lexical organization of the most frequent terms in the textual corpus. As illustrated in the graph, Classes 1 (red) and 2 (gray) are grouped in the upper-left quadrant, indicating a strong correlation among the terms that compose them. This grouping, which minimally extends into the lower-left quadrant, suggests that the concepts represented by these classes are semantically central and interconnected within the study context.
+
+In the upper-right quadrant, proximity is observed among Classes 3 (green), 4 (cyan), and 5 (blue). This spatial arrangement reflects a convergence of meanings, showing that although they are distinct classes, they share a common lexical field. Class 6 (dark blue), also located in this quadrant, subtly extends into the lower-right quadrant, suggesting a relationship—albeit more attenuated—with the predominant concepts in that region of the graph.
+
+Finally, Class 7 (purple) stands out for its isolated position concentrated in the lower-right quadrant. This isolation indicates that the terms in this class possess semantic and lexical specificity, distinguishing them from the other groupings and representing a more particularized conceptual domain in the context of nursing care for pregnant women with syphilis.
+
+This analysis highlights the complexity and underlying structure of the discourse on the subject, revealing patterns of association among terms and concepts in a clear and visual manner.
+
+DISCUSSION
+
+Lexical analysis highlighted the discursive construction of the phenomenon of syphilis in pregnancy. From the grouping of words, semantic cores were identified that express different conceptual axes of care. Although the organization resulted from systematic software processing, the clinical inference was grounded in the researchers’ interpretation(8).
+
+The seven classes were standardized according to the semantic axes they represent: Policy and Access, Management and Service, Community Network, Reception and Bond, Maternal-Child Care, Early Detection, and Diagnosis and Treatment. Each class brings together interrelated terms that, collectively, deepen the understanding of barriers and strategies in preventing vertical transmission.
+
+The analysis was based on Callista Roy’s Adaptation Theory, which views the individual as an adaptive system responding to internal and external stimuli(23). From this perspective, the terms of the classes manifest adaptive processes and challenges imposed by syphilis, reflecting both care demands and coping strategies(24). It is the nurse’s responsibility to recognize these needs in order to promote adaptive balance, aiming for safe pregnancy and the prevention of adverse outcomes for the mother–conceptus dyad(3).
+
+CFA demonstrated proximity between Class 1 – Policy and Access (terms: “regionalization,” “coordination,” “access”) and Class 2 – Management and Service (terms: “resources,” “planning,” “organization”). This connection indicates that public policy formulation is inseparable from the organizational capacity of services. Recent data show that the prevalence of syphilis in pregnancy reached 1.02% in 2019, with a significant increase in previous years. This scenario reflects structural weaknesses in the healthcare network. The literature confirms that failures in planning and resource allocation hinder policy implementation, limit treatment adherence, and compromise comprehensive care(4). Thus, the conceptual overlap between the classes reinforces the need for more efficient and articulated policies capable of addressing inequalities and ensuring maternal and child health(1,2).
+
+The analysis also revealed a strong connection between Class 3 – Community Network and Class 4 -Reception and Bond. The proximity of terms such as “community” and “network” with “listening” and “trust” demonstrates that care for pregnant women with syphilis goes beyond the clinical dimension. Prenatal care in Primary Health Care is a privileged moment for case identification, notification, and treatment(25). In this context, reception and qualified listening become central tools for building trust and bonds, favoring adherence of pregnant women and their partners to treatment(6). The literature also emphasizes the relevance of Community Health Agents (CHAs) in the Family Health Strategy (FHS), whose role contributes to the early identification of pregnant women and health education within the community(26).
+
+Therefore, addressing gestational syphilis must integrate relational, community, and social dimensions. This integration promotes trust, strengthens bonds, and reduces barriers to accessing health services(1,2).
+
+CFA revealed overlap between Class 5 – Maternal-Child Care and Class 6 – Early Detection. In Class 5, terms such as “mother” and “child” emphasize the focus on the dyad and continuity of care. The word “development” points to the relevance of the affective bond, which may be impacted by diagnosis, while “guidance” plays a central role in empowering pregnant women. In parallel, Class 6 gathers terms such as “campaign” and “search,” which reflect the public health pillar of proactive action. “Active search” and “early detection” reinforce the need for agile policies capable of overcoming passive waiting for diagnosis. The overlap of these classes demonstrates that maternal-child care and early detection are interconnected dimensions, forming a unified strategy that depends on bonding, reception, and proactive health services(27).
+
+Class 7 – Diagnosis and Treatment appears in an isolated and concentrated position, marked by technical terms such as “examination” and “prescription.” This separation is not merely graphical but reflects a conceptual dissociation between clinical procedures and the social and human context of pregnant women.
+
+In summary, the results suggest that success in addressing gestational syphilis goes beyond the mere implementation of protocols. It requires articulation between detection and treatment actions (biological), humanized care, practices of reception and bonding (psychosocial), as well as integrated networks, organized and accessible services (management). This integration aligns technical interventions with the social and human dimensions of care, providing support for more precise nursing diagnoses and effective interventions in prenatal care.
+
+CONCLUSION
+
+The lexical analysis of terms related to nursing care for pregnant women with syphilis, in light of the nursing literature, allowed the identification of the most recurrent vocabulary concerning the phenomenon. With the support of the IRaMuTeQ software, a set of terms strongly associated with the theme was highlighted.
+
+The most relevant words were: policy, access, management, services, network, community, reception, bond, care, mother, child, detection, campaign, search, diagnosis, examination, and prescription.
+
+This study of the lexicon of gestational syphilis may contribute to the improvement of nurses’ clinical and critical reasoning. By providing scientific support, it enables the identification of challenges and care strategies, assisting in the formulation of more accurate nursing diagnoses and in the implementation of interventions that consider the clinical, social, and human dimensions of pregnant women.
+
+It is recommended that future studies deepen the analysis of the interrelationship among these terms in order to validate and expand the results obtained.
+
+DATA AVAILABILITY
+
+The entire dataset supporting the results of this study is available upon request to the corresponding author.
+
+DOI: 10.1590/1980-220X-REEUSP-2025-0386pt
+Subjects: Artigo Original
+
+Análise léxica dos termos relacionados ao cuidado de enfermagem à gestante com sífilis
+
+https://orcid.org/0000-0001-8339-6482 Silva Ana Beatriz Pereira da 1
+https://orcid.org/0000-0001-6290-9365 Silva Richardson Augusto Rosendo da 2
+https://orcid.org/0000-0002-6372-8424 Medeiros Jocellem Alves de 1
+https://orcid.org/0009-0000-0646-2669 Queiroz José Leonildo Fernandes de 1
+https://orcid.org/0009-0003-5462-5970 Silva Vitória de Araújo e 2
+https://orcid.org/0000-0002-8782-535x Sales Amanda de Brito Rangel Pereira 1
+https://orcid.org/0009-0005-6148-0575 Galon Jéssica Fernanda 3
+https://orcid.org/0000-0002-2856-8525 Felix Elise Cristina dos Santos 2
+1 Universidade Federal do Rio Grande do Norte, Programa de Pós-Graduação em Enfermagem, Natal, RN, Brasil.
+2 Universidade Federal do Rio Grande do Norte, Departamento de Enfermagem, Natal, RN, Brasil.
+3 Universidade de Ribeirão Preto, Departamento de Enfermagem, Ribeirão Preto, SP, Brasil.
+Autor correspondente: Ana Beatriz Pereira da Silva Avenida Senador Salgado Filho, s/n, Lagoa Nova 59078-970 – Natal, RN, Brasil biapeci@gmail.com
+Keywords: Sífilis, Gestantes, Cuidados de Enfermagem, Cuidado Pré-Natal, Terminologia Padronizada em Enfermagem
+
+INTRODUÇÃO
+
+A sífilis na gestação constitui um relevante problema de saúde pública no Brasil, sobretudo em razão da elevada taxa de transmissão vertical e das graves repercussões maternas e perinatais(1,2). O cuidado à gestante com diagnóstico de sífilis requer uma abordagem integral, sistematizada e fundamentada em evidências.
+
+Nesse contexto, o enfermeiro destaca-se como um dos principais profissionais responsáveis pela execução das ações de cuidado, vigilância e promoção da saúde(3,4). No âmbito da consulta de enfermagem e das demais práticas assistenciais, a utilização de uma linguagem padronizada e tecnicamente precisa é essencial para assegurar a continuidade e a qualidade do atendimento(5).
+
+Entretanto, observa-se que, na prática clínica, persistem lacunas significativas no uso e registro dos termos relacionados ao cuidado às gestantes com sífilis, o que compromete a sistematização das ações e a comunicação multiprofissional. Ademais, os conceitos presentes na literatura científica nem sempre são analisados de forma integrada, dificultando sua incorporação em sistemas de linguagem padronizada, como a CIPE®(6).
+
+A análise lexical de textos científicos possibilita identificar os conceitos mais recorrentes sobre o tema, revelando crenças, práticas e dimensões do cuidado à luz dos discursos acadêmicos da enfermagem(7). Nesse sentido, a lexicografia oferece base teórica e metodológica para a análise da linguagem em uso, permitindo não apenas a identificação de termos relevantes, mas também a compreensão de como refletem saberes consolidados. Com o emprego de ferramentas como a Classificação Hierárquica Descendente (CHD), torna-se possível evidenciar núcleos de sentido e organizá-los em classes temáticas que representam o cotidiano da prática(8).
+
+Na enfermagem, a análise lexical configura-se como estratégia promissora para compreender fenômenos complexos, como a sífilis na gestação. A organização dos termos que compõem esse campo contribui para a construção de subconjuntos terminológicos mais representativos, favorecendo sua incorporação em sistemas classificatórios e a padronização da linguagem nos registros clínicos(9).
+
+Diante disso, questiona-se: como os termos relacionados ao cuidado de enfermagem à gestante com sífilis estão organizados lexicalmente na literatura científica? Assim, o objetivo deste estudo foi analisar o léxico relacionado ao cuidado de enfermagem à gestante com sífilis, a partir da literatura da área.
+
+MÉTODO
+
+Desenho do Estudo
+
+Trata-se de uma scoping review, orientada por protocolo de pesquisa previamente registrado no Open Science Framework (https://osf.io/cs2pe/), conduzida conforme as recomendações do Joanna Briggs Institute Reviewer’s Manual e as diretrizes PRISMA-ScR(10). A revisão seguiu o referencial metodológico de Arksey e O’Malley(11), composto pelas etapas de identificação da questão de pesquisa, seleção dos estudos, mapeamento e extração dos resultados, além da síntese narrativa dos achados.
+
+A questão norteadora foi construída pela estratégia PCC, definida como: P (Population) – mulheres gestantes com sífilis; C (Concept) – cuidados de enfermagem; C (Context) – acompanhamento gestacional. Assim, estabeleceu-se a seguinte pergunta: quais os cuidados de enfermagem direcionados às gestantes com sífilis?
+
+Local do Estudo
+
+As buscas foram realizadas em bases de dados eletrônicas e repositórios de literatura cinzenta, por meio do Portal de Periódicos da CAPES, acessado via Comunidade Acadêmica Federada (CAFe).
+
+População e Critérios de Seleção
+
+Foram incluídas publicações alinhadas ao objetivo da pesquisa e disponíveis na íntegra pelo Portal CAPES, incluindo literatura cinzenta (teses, dissertações e documentos técnicos), sem restrição de ano ou idioma. Excluíram-se editoriais, cartas ao editor, artigos de opinião, ensaios teóricos e revisões narrativas, integrativas, sistemáticas e de escopo.
+
+Coleta de Dados
+
+A identificação de estudos ocorreu em três fases:
+
+Bases indexadas: PubMed/MEDLINE, CINAHL, Web of Science, LILACS e SciELO.
+
+Literatura cinzenta: Portal de Teses e Dissertações da CAPES, Repositório Científico de Acesso Aberto de Portugal (RCAAP), National ETD Portal, Theses Canada e documentos do Ministério da Saúde do Brasil.
+
+Busca manual: listas de referências dos estudos incluídos, para identificar evidências não recuperadas inicialmente.
+
+As buscas foram atualizadas em fevereiro de 2025 e estruturadas com descritores indexados (MeSH/DeCS) e termos livres, combinados com os operadores booleanos AND e OR, adaptados a cada base. Principais chaves de busca: “Syphilis”, “Syphilis, Congenital”, “Pregnant Women”, “Pregnancy”, “Prenatal Care”, “Prenatal Diagnosis”, “Nursing”, “Nursing Care”, além de termos livres como “gestational syphilis”, “maternal syphilis”, “antenatal care”, “prenatal follow-up”, “nurse”, “nursing interventions”, “cuidado de enfermagem” e “pré-natal”.
+
+A seleção foi realizada software Rayyan – Intelligent Systematic Review (https://rayyan.ai/). Dois pesquisadores, de forma independente, analisaram títulos e resumos; os estudos elegíveis foram lidos na íntegra. Divergências foram resolvidas por um terceiro pesquisador, e duplicatas foram consideradas apenas uma vez.
+
+A extração dos dados foi conduzida pelos dois pesquisadores por meio de instrumento estruturado no Microsoft Excel 2019®, com resolução de divergências por consenso. O instrumento contemplou: identificação do estudo (título, autores, ano, periódico, país, idioma), aspectos metodológicos (delineamento, tamanho da amostra), principais resultados e conclusões.
+
+Análise e Tratamento dos Dados
+
+Os estudos foram classificados segundo o nível de evidência do Oxford Centre for Evidence-Based Medicine (OCEBM), variando de revisões sistemáticas de ensaios clínicos randomizados (nível 1a) a opinião de especialistas (nível 5), e segundo a classificação do JBI (níveis 1 a 4). Constituiu-se um corpus textual com trechos de resumos, resultados e considerações finais (excluídas referências), reunido em arquivo único no Microsoft Word e submetido ao IRaMuTeQ.
+
+A análise lexical empregou a Classificação Hierárquica Descendente (CHD) e a Análise Fatorial de Correspondência (AFC), segmentando o texto em unidades de contexto e agrupando segmentos por similaridade lexical e estatística. A interpretação e categorização dos termos seguiu a Teoria da Adaptação de Roy, organizando os dados nos modos fisiológico-funcional, autoconceito-identidade, desempenho de papel e interdependência.
+
+Os resultados foram apresentados por meio do fluxograma PRISMA-ScR (identificação, triagem, elegibilidade e inclusão), tabelas com características metodológicas e principais achados, quadros com síntese do nível de evidência e estratégias de busca, além de figuras geradas pelo IRaMuTeQ (dendro-grama da CHD e mapa fatorial da AFC).
+
+Aspectos Éticos
+
+Por tratar-se de uma revisão de literatura com dados secundários de domínio público, o estudo dispensa aprovação por Comitê de Ética em Pesquisa, respeitando os direitos autorais e a fidedignidade das referências utilizadas.
+
+RESULTADOS
+
+O processo de revisão iniciou-se com a identificação de 10.879 registros em diferentes bases de dados e fontes manuais. A maior parte desses registros foi obtida no PubMed (n = 10.006), seguida pelo Web of Science (n = 350), SciELO (n = 255), Portal de Periódicos CAPES (n = 133), Cochrane (n = 61), LILACS (n = 60) e RCAAP (n = 6). Adicionalmente, foram identificados quatro manuais/protocolos provenientes do Ministério da Saúde.
+
+Na etapa de triagem, 5.219 registros foram excluídos por não atenderem aos critérios de elegibilidade, duplicidade ou por serem irrecuperáveis. Dessa forma, 5.656 estudos foram analisados quanto ao título e resumo, resultando na exclusão de 5.406 registros por irrelevância temática ou por não responderem à questão norteadora.
+
+Um total de 250 estudos seguiu para a avaliação completa da elegibilidade. Após a leitura do texto na íntegra, 241 estudos foram excluídos. Paralelamente, dos quatro relatórios/manuais avaliados por métodos complementares, dois foram considerados inelegíveis. Ao final do processo de seleção, 11 estudos (nove artigos e dois relatórios/manuais) foram incluídos na amostra final desta revisão (Figura 1).
+
+Figura 1 Esquema do processo de seleção dos estudos. Natal, RN, Brasil, 2025.
+
+O corpus textual final da pesquisa foi constituído por 11 documentos, apresentados no Quadro 1, os quais foram processados e segmentados em 641 segmentos de texto (STs). Todos os segmentos foram considerados válidos para a análise lexical, resultando em aproveitamento total (100%).
+
+Quadro 1 Estudos selecionados – Natal, RN, Brasil, 2025
+
+Estudo	País (Ano)	Tipo de publicação/Tipo de estudo/Nível de Evidência	
+E1(12)	Brasil (2020)	Artigo/Qualitativo, descritivo/Nível de Evidência 4	
+E2(13)	Brasil (2019)	Artigo/Quantitativo, descritivo e exploratório/Nível de Evidência 4	
+E3(14)	Brasil (2019)	Artigo/Quantitativo, descritivo e exploratório/Nível de Evidência 4	
+E4(15)	Brasil (2022)	Artigo/Qualitativo, descritivo e exploratório/Nível de Evidência 4	
+E5(16)	Brasil (2021)	Artigo/Qualitativo, descritivo/Nível de Evidência 4	
+E6(17)	Mozambique (2000)	Artigo/Qualitativo, descritivo/Nível de Evidência 2c	
+E7(18)	Brasil (2020)	Artigo/Qualitativo, pesquisa-ação/Nível de Evidência 2c	
+E8(19)	Estados Unidos (1992)	Artigo/Revisão narrativa descritiva/Nível de Evidência 5	
+E9(20)	Reino Unido (1998)	Artigo/Revisão narrativa descritiva/Nível de Evidência 5	
+E10(21)	Brasil (2007)	Manual Técnico/N/A/Não especificado	
+E11(22)	Brasil (2016)	Manual Técnico/N/A/Não especificado	
+
+Após a análise dos dados, estes foram organizados e apresentados em tabelas. Para facilitar a compreensão e a visualização, os estudos foram identificados pela letra “E” (estudo), seguida por números arábicos sequenciais (1, 2, 3, … 11), originando as codificações E1, E2, E3, … E11.
+
+A análise conduzida pelo software IRaMuTeQ permitiu a classificação dos segmentos em sete classes temáticas distintas. Para garantir uniformidade terminológica, as classes foram nomeadas no singular e padronizadas da seguinte forma: Classe 1 – Política e Acesso (16,22%); Classe 2 – Gestão e Serviço (13,51%); Classe 3 – Rede Comunitária (13,51%); Classe 4 – Acolhimento e Vínculo (13,51%); Classe 5 – Cuidado Materno-Infantil (16,22%); Classe 6 – Detecção Precoce (13,51%); e Classe 7 – Diagnóstico e Tratamento (13,51%), conforme descrito na Figura 2.
+
+Figura 2 Diagrama das classes integrantes do dendograma do corpus textual referente aos manuscritos da amostra. Natal, RN, Brasil, 2025.
+
+Essas classes não operam de maneira isolada; ao contrário, representam a trajetória do cuidado de enfermagem, que se inicia nas condições estruturais (Classes 1 e 2), perpassa a relação interpessoal (Classes 3 e 4) e culmina na intervenção clínica direta (Classes 6 e 7).
+
+A relação entre as classes deve ser interpretada da esquerda para a direita. Inicialmente, o corpus foi dividido na primeira iteração, separando a Classe 1 das demais. Na segunda iteração, o subcorpus remanescente foi subdividido em dois, originando a Classe 2 e outro subcorpus. Na terceira iteração, esse último subcorpus foi novamente dividido, gerando a Classe 5 de um lado e um novo subcorpus que, na quarta iteração, deu origem às Classes 3 e 4. A classificação hierárquica descendente foi interrompida nesse ponto, uma vez que as cinco classes apresentaram estabilidade, ou seja, foram compostas por segmentos de texto com vocabulário internamente homogêneo.
+
+A Análise Fatorial de Correspondência (AFC) mapeou a distribuição espacial das classes (Figura 3). As classes identificadas articulam-se diretamente com a prática clínica da enfermagem, ao traduzirem dimensões essenciais do cuidado à gestante com sífilis.
+
+Figura 3 Análise Fatorial de Correspondência das palavras mais frequentes em cada classe lexical, com base em uma classificação hierárquica. Natal, RN, Brasil, 2025.
+
+Os achados lexicais revelam que políticas e gestão (Classes 1 e 2) impactam a organização dos serviços e a garantia de acesso ao pré-natal, enquanto rede comunitária e vínculo (Classes 3 e 4) reforçam a importância da escuta qualificada e da confiança para adesão ao tratamento e rastreamento de parceiros. Já o cuidado materno-infantil e a detecção precoce (Classes 5 e 6) evidenciam a necessidade de ações integradas que assegurem a prevenção da transmissão vertical. Por sua vez, diagnóstico e tratamento (Classe 7) destacam a dimensão técnica que, quando dissociada das demais, pode fragmentar a assistência.
+
+Dessa forma, a análise lexical fortalece o vínculo entre discurso científico e prática clínica, oferecendo subsídios para que o enfermeiro alinhe intervenções técnicas às dimensões relacionais e organizacionais do cuidado.
+
+Na Figura 4, as palavras extraídas do corpus foram correlacionadas aos modos adaptativos da Teoria de Roy. A visualização confirma que o cuidado à gestante com sífilis é multidimensional: termos técnicos articulam-se com termos de suporte social, evidenciando que a adaptação eficaz depende tanto da competência clínica do enfermeiro (diagnóstico e tratamento) quanto da sua capacidade de articulação da rede e de acolhimento.
+
+Figura 4 Termos relacionados ao cuidado à gestante com sífilis à luz do referencial teórico de adaptação de Roy. Natal, RN, Brasil.
+
+A Análise Fatorial de Correspondência (AFC) revelou a organização semântica e lexical dos termos mais frequentes no corpus textual. Conforme ilustrado no gráfico, as Classes 1 (vermelha) e 2 (cinza) encontram-se agrupadas no quadrante superior esquerdo, indicando forte correlação entre os termos que as compõem. Esse agrupamento, que se estende minimamente para o quadrante inferior esquerdo, sugere que os conceitos representados por essas classes são semanticamente centrais e interligados no contexto do estudo.
+
+No quadrante superior direito, observa-se a proximidade entre as Classes 3 (verde), 4 (ciano) e 5 (azul). Tal disposição espacial reflete uma convergência de significados, evidenciando que, embora sejam classes distintas, compartilham um campo lexical comum. A Classe 6 (azul-escuro), também localizada nesse quadrante, avança sutilmente para o quadrante inferior direito, sugerindo uma relação, ainda que mais atenuada, com os conceitos predominantes nessa região do gráfico.
+
+Por fim, a Classe 7 (roxa) destaca-se por sua posição isolada e concentrada no quadrante inferior direito. Esse isolamento indica que os termos dessa classe possuem especificidade semântica e lexical, diferenciando-se dos demais agrupamentos e representando um domínio conceitual mais particularizado no âmbito do cuidado à gestante com sífilis.
+
+Essa análise evidencia a complexidade e a estrutura subjacente do discurso sobre o tema, revelando padrões de associação entre termos e conceitos de forma clara e visual.
+
+DISCUSSÃO
+
+A análise lexical evidenciou a construção discursiva do fenômeno da sífilis na gestação. A partir do agrupamento dos vocábulos, identificaram-se núcleos de sentido que expressam diferentes eixos conceituais do cuidado. Embora a organização decorra do processamento sistemático do software, a inferência clínica fundamentou-se na interpretação dos pesquisadores(8).
+
+As sete classes foram padronizadas conforme os eixos semânticos que representam: Política e Acesso, Gestão e Serviço, Rede Comunitária, Acolhimento e Vínculo, Cuidado Materno-Infantil, Detecção Precoce e Diagnóstico e Tratamento. Cada classe reúne termos inter-relacionados que, em conjunto, aprofundam a compreensão sobre barreiras e estratégias na prevenção da transmissão vertical.
+
+A análise foi fundamentada na Teoria da Adaptação de Callista Roy, que compreende o indivíduo como um sistema adaptativo que responde a estímulos internos e externos(23). Nessa perspectiva, os termos das classes manifestam processos adaptativos e desafios impostos pela sífilis, refletindo tanto demandas de cuidado quanto estratégias de enfrenta-mento(24). Cabe ao enfermeiro reconhecer essas necessidades para promover o equilíbrio adaptativo, visando uma gestação segura e a prevenção de desfechos adversos para a díade mãe-concepto(3).
+
+A AFC demonstrou proximidade entre a Classe 1 – Política e Acesso (termos: “regionalização”, “coordenação”, “acesso”) e a Classe 2 – Gestão e Serviço (termos: “recursos”, “planejamento”, “organização”). Tal conexão indica que a formulação de políticas públicas é indissociável da capacidade organizacional dos serviços. Dados recentes apontam que a prevalência da sífilis na gestação atingiu 1,02% em 2019, com aumento expressivo nos anos anteriores. Esse cenário reflete fragilidades estruturais na rede de atenção. A literatura confirma que falhas no planejamento e na alocação de recursos dificultam a implementação de políticas, limitam a adesão ao tratamento e comprometem a integralidade do cuidado(4). Assim, a sobreposição conceitual entre as classes reforça a necessidade de políticas mais eficientes e articuladas, capazes de enfrentar desigualdades e garantir a saúde materno-infantil(1,2).
+
+A análise também revelou forte conexão entre a Classe 3 – Rede Comunitária e a Classe 4 – Acolhimento e Vínculo. A proximidade de termos como “comunitário” e “rede” com “escutar” e “confiança” demonstra que o cuidado à gestante com sífilis ultrapassa a dimensão clínica. O pré-natal na Atenção Básica é um momento privilegiado para identificação, notificação e tratamento dos casos(25). Nesse contexto, o acolhimento e a escuta qualificada tornam-se ferramentas centrais para a construção do vínculo e da confiança, favorecendo a adesão das gestantes e de seus parceiros ao tratamento(6). A literatura também ressalta a relevância dos Agentes Comunitários de Saúde (ACS) na Estratégia Saúde da Família (ESF), cuja atuação contribui para a captação precoce de gestantes e para a educação em saúde no âmbito comunitário(26).
+
+Portanto, o enfrentamento da sífilis gestacional deve integrar dimensões relacionais, comunitárias e sociais. Essa integração promove confiança, fortalece vínculos e reduz barreiras de acesso aos serviços de saúde(1,2).
+
+A AFC evidenciou sobreposição da Classe 5 – Cuidado Materno-Infantil com a Classe 6 – Detecção Precoce. Na Classe 5, termos como “mãe” e “criança” ressaltam o foco na díade e a continuidade do cuidado. O vocábulo “desenvolvimento” aponta para a relevância do vínculo afetivo, que pode ser impactado pelo diagnóstico, enquanto “orientação” assume papel central no empoderamento da gestante. Paralelamente, a Classe 6 reúne termos como “campanha” e “busca”, que refletem o pilar da saúde pública: a ação proativa. A “busca ativa” e a “detecção precoce” reforçam a necessidade de políticas ágeis, capazes de superar a espera passiva pelo diagnóstico. A sobreposição dessas classes demonstra que o cuidado materno-infantil e a detecção precoce são dimensões interligadas, formando uma estratégia única que depende do vínculo, do acolhimento e da proatividade dos serviços de saúde(27).
+
+A Classe 7 – Diagnóstico e Tratamento aparece em posição isolada e concentrada, marcada por termos técnicos como “exame” e “prescrição”. Essa separação não é apenas gráfica, mas reflete uma dissociação conceitual entre procedimentos clínicos e o contexto social e humano da gestante.
+
+Em síntese, os resultados sugerem que o sucesso no enfrentamento da sífilis gestacional ultrapassa a mera implementação de protocolos. É necessária a articulação entre ações de detecção e tratamento (biológicas), cuidado humanizado, práticas de acolhimento e vínculo (psicossociais), além de rede integrada, serviços organizados e acessíveis (gestão). Essa integração alinha intervenções técnicas às dimensões sociais e humanas do cuidado, oferecendo subsídios para diagnósticos de enfermagem mais precisos e intervenções efetivas na atenção pré-natal.
+
+CONCLUSÃO
+
+A análise lexical dos termos relacionados ao cuidado da gestante com sífilis, à luz da literatura de enfermagem, permitiu identificar o vocabulário mais recorrente sobre o fenômeno. Com o auxílio do software IRaMuTeQ, evidenciou-se um conjunto de termos fortemente associados ao tema.
+
+Os vocábulos mais relevantes foram: políticas, acesso, gestão, serviços, rede, comunitário, acolhimento, vínculo, cuidado, mãe, criança, detecção, campanha, busca, diagnóstico, exame e prescrição.
+
+Este estudo sobre o léxico da sífilis gestacional pode contribuir para o aprimoramento do raciocínio clínico e crítico do enfermeiro. Ao fornecer respaldo científico, possibilita identificar desafios e estratégias de cuidado, auxiliando na formulação de diagnósticos de enfermagem mais precisos e na aplicação de intervenções que considerem as dimensões clínica, social e humana da gestante.
+
+Recomenda-se que pesquisas futuras aprofundem a análise da inter-relação entre esses termos, a fim de validar e expandir os resultados obtidos.
+
+DISPONIBILIDADE DE DADOS
+
+Todo o conjunto de dados que dá suporte aos resultados deste estudo está disponível mediante solicitação ao autor correspondente.
+
+DOI: 10.1590/1980-220X-REEUSP-2025-0386es
+Subjects: Artículo Original
+
+Análisis léxico de los términos relacionados con el cuidado de enfermería a la gestante con sífilis
+
+https://orcid.org/0000-0001-8339-6482 Silva Ana Beatriz Pereira da 1
+https://orcid.org/0000-0001-6290-9365 Silva Richardson Augusto Rosendo da 2
+https://orcid.org/0000-0002-6372-8424 Medeiros Jocellem Alves de 1
+https://orcid.org/0009-0000-0646-2669 Queiroz José Leonildo Fernandes de 1
+https://orcid.org/0009-0003-5462-5970 Silva Vitória de Araújo e 2
+https://orcid.org/0000-0002-8782-535x Sales Amanda de Brito Rangel Pereira 1
+https://orcid.org/0009-0005-6148-0575 Galon Jéssica Fernanda 3
+https://orcid.org/0000-0002-2856-8525 Felix Elise Cristina dos Santos 2
+1 Universidade Federal do Rio Grande do Norte, Programa de Pós-Graduação em Enfermagem, Natal, RN, Brasil.
+2 Universidade Federal do Rio Grande do Norte, Departamento de Enfermagem, Natal, RN, Brasil.
+3 Universidade de Ribeirão Preto, Departamento de Enfermagem, Ribeirão Preto, SP, Brasil.
+Autora correspondiente: Ana Beatriz Pereira da Silva Avenida Senador Salgado Filho, s/n, Lagoa Nova 59078-970 – Natal, RN, Brasil biapeci@gmail.com
+Keywords: Sífilis, Personas Embarazadas, Atención de Enfermería, Atención Prenatal, Terminología Normalizada de Enfermería
+
+INTRODUCCIÓN
+
+La sífilis durante el embarazo constituye un problema de salud pública relevante en Brasil, sobre todo debido a la elevada tasa de transmisión vertical y a las graves repercusiones maternas y perinatales(1,2). La atención a la gestante con diagnóstico de sífilis requiere un enfoque integral, sistematizado y basado en la evidencia.
+
+En este contexto, el enfermero se destaca como uno de los principales profesionales responsables de la ejecución de las acciones de cuidado, vigilancia y promoción de la salud(3,4). En el ámbito de la consulta de enfermería y de las demás prácticas asistenciales, el uso de un lenguaje estandarizado y técnicamente preciso es esencial para asegurar la continuidad y la calidad de la atención(5).
+
+Sin embargo, se observa que, en la práctica clínica, persisten lagunas significativas en el uso y registro de los términos relacionados con la atención a las gestantes con sífilis, lo que compromete la sistematización de las acciones y la comunicación multiprofesional. Además, los conceptos presentes en la literatura científica no siempre se analizan de manera integrada, lo que dificulta su incorporación en sistemas de lenguaje estandarizado, como el CIPE®(6).
+
+El análisis léxico de textos científicos permite identificar los conceptos más recurrentes sobre el tema, revelando creencias, prácticas y dimensiones de la atención a la luz de los discursos académicos de enfermería(7). En este sentido, la lexicografía ofrece una base teórica y metodológica para el análisis del lenguaje en uso, permitiendo no solo la identificación de términos relevantes, sino también la comprensión de cómo reflejan conocimientos consolidados. Con el empleo de herramientas como la CJD, es posible evidenciar núcleos de sentido y organizarlos en clases temáticas que representan el día a día de la práctica(8).
+
+En enfermería, el análisis léxico se configura como una estrategia prometedora para comprender fenómenos complejos, como la sífilis en el embarazo. La organización de los términos que componen este campo contribuye a la construcción de subconjuntos terminológicos más representativos, favoreciendo su incorporación en sistemas clasificatorios y la estandarización del lenguaje en los registros clínicos(9).
+
+Ante esto, se plantea la pregunta: ¿cómo se organizan léxicamente en la literatura científica los términos relacionados con la atención de enfermería a la gestante con sífilis? Así, el objetivo de este estudio fue analizar el léxico relacionado con la atención de enfermería a la gestante con sífilis, a partir de la literatura del área.
+
+MÉTODO
+
+Diseño del Estudio
+
+Se trata de una revisión de alcance (scoping review), guiada por un protocolo de investigación previamente registrado en el Open Science Framework (https://osf.io/cs2pe/), realizada de acuerdo con las recomendaciones del Joanna Briggs Institute Reviewer’s Manual y las directrices PRISMA-ScR(10). La revisión siguió el marco metodológico de Arksey y O’Malley(11), compuesto por las etapas de identificación de la pregunta de investigación, selección de los estudios, mapeo y extracción de los resultados, además de la síntesis narrativa de los hallazgos.
+
+La pregunta orientadora se construyó mediante la estrategia PCC, definida como: P (Población) – mujeres embarazadas con sífilis; C (Concepto) – cuidados de enfermería; C (Contexto) – seguimiento del embarazo. Así, se estableció la siguiente pregunta: ¿cuáles son los cuidados de enfermería dirigidos a las mujeres embarazadas con sífilis?
+
+Lugar del Estudio
+
+Las búsquedas se realizaron en bases de datos electrónicas y repositorios de literatura gris, a través del Portal de Periódicos de CAPES, al que se accedió vía la Comunidad Académica Federada (CAFe).
+
+Población y Criterios de Selección
+
+Se incluyeron publicaciones alineadas con el objetivo de la investigación y disponibles en su totalidad a través del Portal CAPES, incluyendo literatura gris (tesis, disertaciones y documentos técnicos), sin restricción de año o idioma. Se excluyeron editoriales, cartas al editor, artículos de opinión, ensayos teóricos y revisiones narrativas, integrativas, sistemáticas y de alcance.
+
+Recolección de Datos
+
+La identificación de los estudios se llevó a cabo en tres fases:
+
+Bases de datos indexadas: PubMed/MEDLINE, CINAHL, Web of Science, LILACS y SciELO.
+
+Literatura gris: Portal de Tesis y Disertaciones de CAPES, Repositorio Científico de Acceso Abierto de Portugal (RCAAP), National ETD Portal, Theses Canada y documentos del Ministerio de Salud de Brasil.
+
+Búsqueda manual: listas de referencias de los estudios incluidos, para identificar la evidencia no recuperada inicialmente.
+
+Las búsquedas se actualizaron en febrero de 2025 y se estructuraron con descriptores indexados (MeSH/DeCS) y términos libres, combinados con los operadores booleanos AND y OR, adaptados a cada base. Principales palabras clave de búsqueda: “Syphilis”, “Syphilis, Congenital”, “Pregnant Women”, “Pregnancy”, “Prenatal Care”, “Prenatal Diagnosis”, “Nursing”, “Nursing Care”, además de términos libres como “gestational syphilis”, “maternal syphilis”, “antenatal care”, “prenatal followup”, “nurse”, “nursing interventions”, “cuidado de enfermagem” y “pré-natal”.
+
+La selección se llevó a cabo mediante el software Rayyan – Intelligent Systematic Review (https://rayyan.ai/). Dos investigadores, de forma independiente, analizaron los títulos y los resúmenes; los estudios elegibles se leyeron en su totalidad. Las discrepancias fueron resueltas por un tercer investigador, y los duplicados se consideraron solo una vez.
+
+La extracción de datos fue realizada por los dos investigadores mediante un instrumento estructurado en Microsoft Excel 2019®, resolviendo las discrepancias por consenso. El instrumento incluyó: identificación del estudio (título, autores, año, revista, país, idioma), aspectos metodológicos (diseño, tamaño de la muestra), principales resultados y conclusiones.
+
+Análisis y Tratamiento de los Datos
+
+Los estudios se clasificaron según el nivel de evidencia del Oxford Centre for Evidence-Based Medicine (OCEBM), que varía desde revisiones sistemáticas de ensayos clínicos aleatorios (nivel 1a) hasta la opinión de expertos (nivel 5), y según la clasificación del JBI (niveles 1 a 4). Se constituyó un corpus textual con fragmentos de resúmenes, resultados y consideraciones finales (excluidas las referencias), reunidos en un único archivo en Microsoft Word y sometido a IRaMuTeQ.
+
+El análisis léxico empleó la Clasificación Jerárquica Descendente (CJD) y el Análisis Factorial de Correspondencia (AFC), segmentando el texto en unidades de contexto y agrupando segmentos por similitud léxica y estadística. La interpretación y categorización de los términos siguió la Teoría de la Adaptación de Roy, organizando los datos en los modos fisiológico-funcional, autoconcepto-identidad, desempeño de roles e interdependencia.
+
+Los resultados se presentaron mediante el diagrama de flujo PRISMA-ScR (identificación, selección, elegibilidad e inclusión), tablas con características metodológicas y hallazgos principales, cuadros con un resumen del nivel de evidencia y estrategias de búsqueda, además de figuras generadas por IRaMuTeQ (dendrograma de la CJD y mapa factorial de la AFC).
+
+Aspectos Éticos
+
+Al tratarse de una revisión bibliográfica con datos secundarios de dominio público, el estudio no requiere la aprobación de un Comité de Ética en Investigación, respetando los derechos de autor y la fiabilidad de las referencias utilizadas.
+
+RESULTADOS
+
+El proceso de revisión se inició con la identificación de 10 879 registros en diferentes bases de datos y fuentes manuales. La mayor parte de estos registros se obtuvo en PubMed (n = 10 006), seguida de Web of Science (n = 350), SciELO (n = 255), Portal de Periódicos CAPES (n = 133), Cochrane (n = 61), LILACS (n = 60) y RCAAP (n = 6). Además, se identificaron cuatro manuales/protocolos del Ministerio de Salud.
+
+En la etapa de selección, se excluyeron 5.219 registros por no cumplir con los criterios de elegibilidad, por duplicidad o por ser irrecuperables.
+
+De este modo, se analizaron 5.656 estudios en cuanto al título y el resumen, lo que dio lugar a la exclusión de 5.406 registros por irrelevancia temática o por no responder a la pregunta guía.
+
+Un total de 250 estudios pasaron a la evaluación completa de la elegibilidad. Tras la lectura del texto completo, se excluyeron 241 estudios. Paralelamente, de los cuatro informes/manuales evaluados mediante métodos complementarios, dos se consideraron no elegibles. Al final del proceso de selección, 11 estudios (nueve artículos y dos informes/manuales) se incluyeron en la muestra final de esta revisión (Figura 1).
+
+Figura 1 Esquema del proceso de selección de los estudios. Natal, RN, Brasil, 2025.
+
+El corpus textual final de la investigación estuvo compuesto por 11 documentos, presentados en el Cuadro 1, los cuales fueron procesados y segmentados en 641 segmentos de texto (ST). Todos los segmentos se consideraron válidos para el análisis léxico, lo que dio como resultado un aprovechamiento total (100 %).
+
+Cuadro 1 Estudos selecionados – Natal, RN, Brasil, 2025.
+
+Estudio	País (Año)	Tipo de publicación/Tipo de estudio/Nivel de Evidencia	
+E1(12)	Brasil (2020)	Artículo/Cualitativo, descriptivo/Nivel de evidencia 4	
+E2(13)	Brasil (2019)	Artículo/Cuantitativo, descriptivo y exploratorio/Nivel de evidencia 4	
+E3(14)	Brasil (2019)	Artículo/Cuantitativo, descriptivo y exploratorio/Nivel de evidencia 4	
+E4(15)	Brasil (2022)	Artículo/Cualitativo, descriptivo y exploratorio/Nivel de evidencia 4	
+E5(16)	Brasil (2021)	Artículo/Cualitativo, descriptivo/Nivel de evidencia 4	
+E6(17)	Mozambique (2000)	Artículo/Cualitativo, descriptivo/Nivel de evidencia 2c	
+E7(18)	Brasil (2020)	Artículo/Cualitativo, investigación-acción/Nivel de evidencia 2c	
+E8(19)	Estados Unidos (1992)	Artículo/Revisión narrativa descriptiva/Nivel de evidencia 5	
+E9(20)	Reino Unido (1998)	Artículo/Revisión narrativa descriptiva/Nivel de evidencia 5	
+E10(21)	Brasil (2007)	Manual técnico/N/A/No especificado	
+E11(22)	Brasil (2016)	Manual técnico/N/A/No especificado	
+
+Tras el análisis de los datos, estos se organizaron y presentaron en tablas. Para facilitar la comprensión y la visualización, los estudios se identificaron con la letra «E» (estudio), seguida de números arábigos secuenciales (1, 2, 3, … 11), lo que dio lugar a las codificaciones E1, E2, E3, … E11.
+
+El análisis realizado por el software IRaMuTeQ permitió clasificar los segmentos en siete clases temáticas distintas. Para garantizar la uniformidad terminológica, las clases se denominaron en singular y se estandarizaron de la siguiente manera: Clase 1 – Política y Acceso (16,22 %); Clase 2 – Gestión y Servicio (13,51 %); Clase 3 – Red Comunitaria (13,51 %); Clase 4 – Acogida y vínculo (13,51 %); Clase 5 – Atención materno-infantil (16,22 %); Clase 6 – Detección temprana (13,51 %); y Clase 7 – Diagnóstico y tratamiento (13,51 %), tal como se describe en la Figura 2.
+
+Figura 2 Diagrama de las clases que componen el Dendograma del corpus textual (en portugués) correspondiente a los manuscritos de la muestra. Natal, RN, Brasil, 2025.
+
+Estas clases no operan de manera aislada; por el contrario, representan la trayectoria de la atención de enfermería, que se inicia en las condiciones estructurales (Clases 1 y 2), atraviesa la relación interpersonal (Clases 3 y 4) y culmina en la intervención clínica directa (Clases 6 y 7).
+
+La relación entre las clases debe interpretarse de izquierda a derecha. Inicialmente, el corpus se dividió en la primera iteración, separando la Clase 1 del resto. En la segunda iteración, el subcorpus restante se subdividió en dos, dando origen a la Clase 2 y a otro subcorpus. En la tercera iteración, este último subcorpus se dividió nuevamente, generando la Clase 5 por un lado y un nuevo subcorpus que, en la cuarta iteración, dio origen a las Clases 3 y 4. La clasificación jerárquica descendente se interrumpió en ese punto, ya que las cinco clases presentaron estabilidad, es decir, estaban compuestas por segmentos de texto con un vocabulario internamente homogéneo.
+
+El Análisis Factorial de Correspondencia (AFC) mapeó la distribución espacial de las clases (Figura 3). Las clases identificadas se articulan directamente con la práctica clínica de la enfermería, al traducir dimensiones esenciales de la atención a la gestante con sífilis.
+
+Figura 3 Análisis factorial de correspondencias de las palabras (en portugués) más frecuentes en cada clase léxica, basado en una clasificación jerárquica. Natal, RN, Brasil, 2025.
+
+Los hallazgos léxicos revelan que las políticas y la gestión (Clases 1 y 2) influyen en la organización de los servicios y en la garantía de acceso a la atención prenatal, mientras que la red comunitaria y el vínculo (Clases 3 y 4) refuerzan la importancia de la escucha cualificada y de la confianza para la adherencia al tratamiento y el rastreo de parejas. Por su parte, la atención materno-infantil y la detección temprana (Clases 5 y 6) evidencian la necesidad de acciones integradas que aseguren la prevención de la transmisión vertical. A su vez, el diagnóstico y el tratamiento (Clase 7) destacan la dimensión técnica que, cuando se disocia de las demás, puede fragmentar la asistencia.
+
+De este modo, el análisis léxico fortalece el vínculo entre el discurso científico y la práctica clínica, ofreciendo recursos para que el enfermero alinee las intervenciones técnicas con las dimensiones relacionales y organizacionales de la atención.
+
+En la Figura 4, las palabras extraídas del corpus se correlacionaron con los modos adaptativos de la Teoría de Roy. La visualización confirma que la atención a la gestante con sífilis es multidimensional: los términos técnicos se articulan con términos de apoyo social, lo que evidencia que la adaptación eficaz depende tanto de la competencia clínica del enfermero (diagnóstico y tratamiento) como de su capacidad para articular la red y brindar acogida.
+
+Figura 4 Términos relacionados con la atención a las gestantes con sífilis a la luz del marco teórico de adaptación de Roy. Natal, RN, Brasil.
+
+El análisis factorial de correspondencias (AFC) reveló la organización semántica y léxica de los términos más frecuentes en el corpus textual. Como se ilustra en el gráfico, las Clases 1 (roja) y 2 (gris) se encuentran agrupadas en el cuadrante superior izquierdo, lo que indica una fuerte correlación entre los términos que las componen. Esta agrupación, que se extiende mínimamente hacia el cuadrante inferior izquierdo, sugiere que los conceptos representados por estas clases son semánticamente centrales e interrelacionados en el contexto del estudio.
+
+En el cuadrante superior derecho, se observa la proximidad entre las Clases 3 (verde), 4 (cian) y 5 (azul). Esta disposición espacial refleja una convergencia de significados, lo que evidencia que, aunque son clases distintas, comparten un campo léxico común. La Clase 6 (azul oscuro), también ubicada en este cuadrante, se adentra sutilmente hacia el cuadrante inferior derecho, lo que sugiere una relación, aunque más atenuada, con los conceptos predominantes en esa región del gráfico.
+
+Por último, la Clase 7 (morado) se destaca por su posición aislada y concentrada en el cuadrante inferior derecho. Este aislamiento indica que los términos de esta clase poseen especificidad semántica y léxica, diferenciándose de los demás grupos y representando un dominio conceptual más particularizado en el ámbito de la atención a la gestante con sífilis.
+
+Este análisis pone de manifiesto la complejidad y la estructura subyacente del discurso sobre el tema, revelando patrones de asociación entre términos y conceptos de forma clara y visual.
+
+DISCUSIÓN
+
+El análisis léxico puso de manifiesto la construcción discursiva del fenómeno de la sífilis en el embarazo. A partir de la agrupación de los términos, se identificaron núcleos de sentido que expresan diferentes ejes conceptuales de la atención. Aunque la organización es resultado del procesamiento sistemático del software, la inferencia clínica se basó en la interpretación de los investigadores(8).
+
+Las siete clases se estandarizaron de acuerdo con los ejes semánticos que representan: Política y Acceso, Gestión y Servicio, Red Comunitaria, Acogida y Vínculo, Atención Materno-Infantil, Detección Temprana y Diagnóstico y Tratamiento. Cada clase reúne términos interrelacionados que, en conjunto, profundizan la comprensión sobre las barreras y estrategias en la prevención de la transmisión vertical.
+
+El análisis se basó en la Teoría de la Adaptación de Callista Roy, que concibe al individuo como un sistema adaptativo que responde a estímulos internos y externos(23). Desde esta perspectiva, los términos de las clases manifiestan procesos adaptativos y desafíos impuestos por la sífilis, reflejando tanto las demandas de atención como las estrategias de afrontamiento(24). Corresponde al personal de enfermería reconocer estas necesidades para promover el equilibrio adaptativo, con el objetivo de lograr un embarazo seguro y la prevención de resultados adversos para la díada madre-feto(3).
+
+El AFC demostró una proximidad entre la Clase 1 — Política y Acceso (términos: «regionalización», «coordinación», «acceso»)— y la Clase 2 —Gestión y Servicio (términos: «recursos», «planificación», «organización»)—.
+
+Dicha conexión indica que la formulación de políticas públicas es indisociable de la capacidad organizativa de los servicios. Datos recientes señalan que la prevalencia de la sífilis en el embarazo alcanzó el 1,02 % en 2019, con un aumento significativo en los años anteriores. Este escenario refleja fragilidades estructurales en la red de atención. La literatura confirma que las fallas en la planificación y la asignación de recursos dificultan la implementación de políticas, limitan la adherencia al tratamiento y comprometen la integralidad de la atención(4). Así, la superposición conceptual entre las clases refuerza la necesidad de políticas más eficientes y articuladas, capaces de enfrentar las desigualdades y garantizar la salud materno-infantil(1,2).
+
+El análisis también reveló una fuerte conexión entre la Clase 3 —Red Comunitaria— y la Clase 4 —Acogida y Vínculo—. La proximidad de términos como «comunitario» y «red» con «escuchar» y «confianza» demuestra que la atención a la gestante con sífilis trasciende la dimensión clínica. La atención prenatal en la atención primaria es un momento privilegiado para la identificación, notificación y tratamiento de los casos(25). En este contexto, la acogida y la escucha cualificada se convierten en herramientas centrales para la construcción del vínculo y la confianza, favoreciendo la adherencia de las gestantes y sus parejas al tratamiento(6). La literatura también destaca la relevancia de los Agentes Comunitarios de Salud (ACS) en la Estrategia de Salud Familiar (ESF), cuya actuación contribuye a la detección temprana de las gestantes y a la educación en salud en el ámbito comunitario(26).
+
+Por lo tanto, la lucha contra la sífilis gestacional debe integrar dimensiones relacionales, comunitarias y sociales. Esta integración promueve la confianza, fortalece los vínculos y reduce las barreras de acceso a los servicios de salud(1,2).
+
+El AFC evidenció una superposición de la Clase 5 — Atención Materno-Infantil— con la Clase 6 —Detección Temprana—. En la Clase 5, términos como «madre» y «niño» resaltan el enfoque en la díada y la continuidad de la atención. El término «desarrollo» apunta a la relevancia del vínculo afectivo, que puede verse afectado por el diagnóstico, mientras que «orientación» asume un papel central en el empoderamiento de la gestante. Paralelamente, la Clase 6 reúne términos como «campaña» y «búsqueda», que reflejan el pilar de la salud pública: la acción proactiva. La «búsqueda activa» y la «detección temprana» refuerzan la necesidad de políticas ágiles, capaces de superar la espera pasiva del diagnóstico. La superposición de estas clases demuestra que la atención materno-infantil y la detección temprana son dimensiones interrelacionadas, que forman una estrategia única que depende del vínculo, la acogida y la proactividad de los servicios de salud(27).
+
+La Clase 7 —Diagnóstico y tratamiento— aparece en una posición aislada y concentrada, marcada por términos técnicos como «examen» y «prescripción». Esta separación no es solo gráfica, sino que refleja una disociación conceptual entre los procedimientos clínicos y el contexto social y humano de la gestante.
+
+En resumen, los resultados sugieren que el éxito en el manejo de la sífilis gestacional va más allá de la mera implementación de protocolos. Es necesaria la articulación entre acciones de detección y tratamiento (biológicas), atención humanizada, prácticas de acogida y vínculo (psicosociales), además de una red integrada y servicios organizados y accesibles (gestión). Esta integración alinea las intervenciones técnicas con las dimensiones sociales y humanas de la atención, ofreciendo fundamentos para diagnósticos de enfermería más precisos e intervenciones efectivas en la atención prenatal.
+
+CONCLUSIÓN
+
+El análisis léxico de los términos relacionados con la atención a la gestante con sífilis, a la luz de la literatura de enfermería, permitió identificar el vocabulario más recurrente sobre el fenómeno. Con la ayuda del software IRaMuTeQ, se evidenció un conjunto de términos fuertemente asociados al tema.
+
+Los términos más relevantes fueron: políticas, acceso, gestión, servicios, red, comunitario, acogida, vínculo, atención, madre, niño, detección, campaña, búsqueda, diagnóstico, examen y prescripción.
+
+Este estudio sobre el léxico de la sífilis gestacional puede contribuir a mejorar el razonamiento clínico y crítico del personal de enfermería. Al proporcionar respaldo científico, permite identificar desafíos y estrategias de atención, lo que ayuda a formular diagnósticos de enfermería más precisos y a aplicar intervenciones que tengan en cuenta las dimensiones clínicas, sociales y humanas de la gestante.
+
+Se recomienda que futuras investigaciones profundicen en el análisis de la interrelación entre estos términos, con el fin de validar y ampliar los resultados obtenidos.
+
+DISPONIBILIDAD DE DATOS
+
+El conjunto de datos que respaldan las conclusiones de este estudio está disponible previa solicitud al autor correspondiente.
+
+EDITORA ASSOCIADA: Marcia Regina Cubas
+
+EDITORA ASOCIADA: Marcia Regina Cubas
+
+
+REFERENCES
+
+1. Dantas JDC Marinho CDSR Pinheiro YT Ferreira MÂF Silva RAR Temporal trend and factors associated with spatial distribution of congenital syphilis in Brazil: an ecological study. Front Pediatr 2023 11 1109271 10.3389/fped.2023.1109271 37033177 PMC10075361
+2. Dantas JC Marinho CDSR Pinheiro YT Ferreira MÂF Silva RAR Spatial distribution of gestational syphilis in Brazil: socioeconomic and health services inequalities. Am J Trop Med Hyg 2023 109 1 42 49 10.4269/ajtmh.22-0449 37188340 PMC10324014
+3. Raimundo DML Sousa GJB Silva ABP Almino RHSC Prado NCC Silva RAR Spatial analysis of congenital syphilis in Rio Grande do Norte, 2008 2018. Rev Esc Enferm USP 2021 55 e20200578 10.1590/1980-220x-reeusp-2020-0578 34605532
+4. Pereira MVS Oliveira CWS Cardoso MNCM Leite JDL Paula PA Araujo JGG Challenges and interventions of primary health care in Brazil in the approach to gestational syphilis. EJCH 2024 [cited 2025 Dec 10] 24 2 e15405 Available from: https://acervomais.com.br/index.php/saude/article/view/15405
+5. Macêdo VC Romaguera LMD Ramalho MOA Vanderlei LCM Frias PG Lira PIC Sífilis na gestação: barreiras na assistência pré natal para o controle da transmissão vertical. Cad Saude Colet 2020 28 4 518 528 10.1590/1414-462x202028040395
+6. Nascimento DE Ferreira MS Luna No RT Faccio PF Santos AV Spacov IC Os riscos da detecção tardia de sífilis gestacional na perspectiva da enfermagem. Enferm Foco 2024 15 Suppl 2 S65 S71 10.21675/2357-707X.2024.v15.e-202408SUPL2
+7. Dantas AMN Silva KL Reichert APS Oliveira JS Nóbrega MML Análise léxica dos termos “crescimento e desenvolvimento” infantil. Acta Paul Enferm 2023 36 eAPE03192 10.37689/acta-ape/2023AR03192
+8. Camargo BZ Justo AM Tutorial for the use of IRaMuTeQ software [Internet]. Florianópolis: Federal University of Santa Catarina 2021 [cited 2025 Dec 10] Available from: http://www.iramuteq.org/documentation/fichiers/Tutorial%20IRaMuTeQ%20em%20portugues_17.3.pdf
+9. Ferrari ADS Mattei FD Gomes DC Campozana LH Castro JEFPD Hammerschmidt KSDA Termos da linguagem especializada de enfermagem no cuidado à pessoa com dor crônica. REME 2024 28 e1555 10.35699/2316-9389.2024.48678
+10. Peters MDJ Godfrey C McInerney P Munn Z Tricco AC Khalil H Scoping reviews Aromataris E Munn Z JBI manual for evidence synthesis [Internet] Adelaide JBI 2020 [cited 2025 Dec 10] Available from: https://synthesismanual.jbi.global
+11. Arksey H O’Malley L Scoping studies: towards a methodological framework. Int J Soc Res Methodol 2005 8 1 19 32 10.1080/1364557032000119616
+12. Gomes NS Prates LA Wilhelm LA Lipinski JM Velozo KDS Pilger CH “Só sei que é uma doença”: conhecimento de gestantes sobre sífilis. Rev Bras Promoc Saude 2021 34 10.5020/18061230.2021.10964
+13. Felipe CN Freitas DS Cerqueira LDC Oliveira PP Sampaio CEP Koeppe GBO Puérperas de sífilis congênita de uma maternidade de Cabo Frio RJ: levantamento do perfil epidemiológico. Nursing 2019 22 255 3105 3111 10.36489/nursing.2019v22i255p3105-3110
+14. Silva JG Gomes GC Ribeiro JP Jung BCD Norberg PKO Mota MS Sífilis gestacional: repercussões para a puérpera. Cogitare Enferm 2019 24 e65578 10.5380/ce.v24i0.65578
+15. Felix VC Teixeira SVB Silva LR Penna LHG Barreto ACM Pereira AL External environment of woman and congenital syphilis in the light of Levine’s Conservation Theory. Rev Enferm UERJ 2022 30 1 e64047 10.12957/reuerj.2022.64047
+16. Moreira WC Sousa DA Jr Cruz SNSL Santos DM Campelo LLCR Sousa FSP Singular therapeutic project for a pregnant woman with syphilis: an experience report. Rev Enferm UFPE Online 2021 15 2 e245046 10.5205/1981-8963.2021.245046
+17. Osman NB Challis K Folgosa E Cotiro M Bergström S An intervention study to reduce adverse pregnancy outcomes as a result of syphilis in Mozambique. Sex Transm Infect 2000 76 3 203 207 10.1136/sti.76.3.203 10961199 PMC1744159
+18. Silva VBS Backes MTS Mello JFD Magagnin JS Brasil JM Silva CID Collective construction of a flowchart for follow up of pregnant women with syphilis in São José SC. Cogitare Enferm 2020 25 e65361 10.5380/ce.v25i0.65361
+19. Crane MJ The diagnosis and management of maternal and congenital syphilis. J Nurse Midwifery 1992 37 1 4 16 10.1016/0091-2182(92)90017-W 1538267
+20. Peate I Syphilis: signs, symptoms, treatment and nursing management. Br J Nurs 1998 7 14 817 823 10.12968/bjon.1998.7.14.5633 9849142
+21. Ministério da Saúde (BR). Protocolo para a prevenção de transmissão vertical de HIV e sífilis: manual de bolso [Internet]. Brasília: Ministério da Saúde; 2007 [cited 2025 Dec 10]. 180 Available from: https://bvsms.saude.gov.br/bvs/publicacoes/protocolo_prevencao_transmissao_verticalhivsifilis_manualbolso.pdf
+22. Ministério da Saúde (BR). Diretrizes para o controle da sífilis congênita [Internet]. Brasília: Ministério da Saúde; 2005 [cited 2025 Dec 10]. 52 Available from: https://bvsms.saude.gov.br/bvs/publicacoes/diretrizes_controle_sifilis_congenita.pdf
+23. Roy C El modelo de adaptación de Roy en el contexto de los modelos de enfermería, con ejemplos de aplicación y dificultades. Cult Cuid 2012 7-8 139 159 10.14198/cuid.2000.7-8.17
+24. Menezes HFD Camacho ACLF Nóbrega MMLD Fuly PDSC Fernandes SF Silva RARD Paths taken by Brazilian Nursing for the development of terminological subsets. Rev Lat Am Enfermagem 2020 28 e3270 10.1590/1518-8345.3132.3270 32401904 PMC7217630
+25. Laurentino ACN Ramos BA Lira CS Lessa IF Taquette SR Atenção à saúde dos parceiros sexuais de adolescentes com sífilis gestacional e seus filhos: revisão integrativa. Cien Saude Colet 2024 29 5 e12162023 10.1590/1413-81232024295.12162023en 38747774
+26. Santos PA Gomes AA Ações na Estratégia Saúde da Família para combate à sífilis congênita. Rev Baiana Saude Publica. 2019 43 Suppl 1 85 93 10.22278/2318-2660.2019.v43.n0.a3217
+27. Uchôa TLDA Araújo EDC Silva RAR Valois R Azevedo WSA Jr Nascimento VGC Determinants of gestational syphilis among women attending prenatal care programs in the Brazilian Amazon. Front Public Health 2022 10 930150 10.3389/fpubh.2022.930150 36438302 PMC9683036
diff --git a/corpus/healthcare/text/a735f4f8e9299f64.txt b/corpus/healthcare/text/a735f4f8e9299f64.txt
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index 0000000000000000000000000000000000000000..9a3ad45fae2ee2f72325eafa79899d8a6a736ce1
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@@ -0,0 +1,301 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Support Care Cancer
+Journal ID: Support Care Cancer
+NLM Journal ID: 9302957
+
+Supportive Care in Cancer
+
+ISSN: 0941-4355
+EISSN: 1433-7339
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13529886
+PMID: 42671592
+DOI: 10.1007/s00520-026-11139-2
+Article ID: 11139
+Article version: 1
+Subjects: Review
+
+Evidence supporting endodontic therapy as a safe strategy in patients previously treated with head and neck radiotherapy: a scoping review
+
+http://orcid.org/0009-0006-8203-9321 Wanderley Álvaro Souza 1
+http://orcid.org/0000-0003-2038-1616 de Sousa Wesley Viana 1
+http://orcid.org/0009-0000-6363-5343 da Costa Maria Olívia 1
+http://orcid.org/0000-0002-6293-3709 de Mendonça Silva Alícia Marcelly Souza 2
+http://orcid.org/0000-0002-8250-4469 de Albuquerque Raylane Farias 2
+http://orcid.org/0000-0002-7559-2608 Silva Igor Henrique Morais 2
+http://orcid.org/0000-0002-9284-749X Ribeiro Lucas Nascimento 2 3
+http://orcid.org/0000-0002-7897-2489 Albuquerque Diana Santana 1
+http://orcid.org/0000-0003-4145-5565 Barbosa-Ribeiro Marlos marlos.ribeiro@upe.br
+1 3
+1 https://ror.org/00gtcbp88 grid.26141.30 0000 0000 9011 5442 School of Dentistry of Pernambuco, Postgraduate Program in Dentistry, University of Pernambuco, Recife, PE 50040-200 Brazil
+2 Department of Dentistry at the Pernambuco Cancer Hospital, Recife, PE 50040-000 Brazil
+3 https://ror.org/00gtcbp88 grid.26141.30 0000 0000 9011 5442 School of Dentistry of Arcoverde, University of Pernambuco, Campus Arcoverde, Rua Cícero Monteiro de Melo, S/N, São Cristóvão, Arcoverde, PE 56503-146 Brazil
+Electronic publication date: 2026 Aug 31
+Print publication date: 2026
+Volume: 34
+Issue: 9
+Electronic Location ID: 913
+Received 2026 Feb 14; Accepted 2026 Aug 17
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Endodontics, Radiotherapy, Head and neck cancer, Osteoradionecrosis
+
+Funding: Universidade De Pernambuco The Article Processing Charge (APC) for the publication of this research was funded by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) (ROR identifier: 00x0ma614).
+
+issue-copyright-statement: © Springer-Verlag GmbH Germany, part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Purpose
+
+To map and synthesize the available scientific evidence supporting the effectiveness and safety of endodontic therapy in patients who underwent head and neck radiotherapy, considering clinical and radiographic outcomes and treatment-related complications, particularly osteoradionecrosis (ORN).
+
+Methods
+
+This scoping review followed the Arksey and O’Malley framework, informed by the Joanna Briggs Institute Manual for Evidence Synthesis, and was reported according to PRISMA-ScR guidelines. Comprehensive searches were conducted in PubMed, Embase, Scopus, Web of Science, MEDLINE, LILACS, and gray literature sources, with no date restrictions. Clinical studies evaluating endodontic therapy in irradiated patients were included. Data were charted and narratively synthesized using a Population–Concept–Context framework. Consistent with scoping review methodology, no critical appraisal was performed.
+
+Results
+
+Of 174 identified records, five studies met the inclusion criteria. Reported success rates ranged from 18 to 100%, with lower rates observed in earlier studies employing outdated techniques. More recent investigations demonstrated high clinical success, improved radiographic stability, and no reported cases of ORN. Across all studies, endodontic therapy was not associated with ORN. However, methodological heterogeneity was noted, particularly regarding outcome definitions and follow-up duration.
+
+Conclusion
+
+Endodontic therapy appears to be a safe and conservative treatment option for patients with head and neck cancer who underwent radiotherapy and may reduce the need for invasive procedures associated with ORN risk. However, the limited and heterogeneous evidence highlights the need for well-designed prospective studies to support standardized clinical decision-making within supportive oncology care.
+
+Introduction
+
+Head and neck cancer represents a major global health burden, characterized by substantial incidence rates, significant mortality, and persistent challenges related to early diagnosis [1]. According to the International Agency for Research on Cancer of the World Health Organization, malignancies arising in the head and neck region rank among the most frequently diagnosed cancers worldwide [2]. In 2022, GLOBOCAN estimated a global incidence of head and neck cancer of approximately 940,000 new cases and about 480,000 deaths, corresponding to nearly half the number of newly diagnosed cases [3]. In Brazil, projections from the National Cancer Institute estimate approximately 781,000 new cases in 2026 [4]. The multifactorial etiology of head and neck cancer, combined with the absence of reliable early diagnostic markers, contributes to the high proportion of cases diagnosed at advanced stages. Consequently, nearly 80% of patients present with late-stage disease, a scenario that dramatically compromises prognosis, with 5-year survival rates declining from approximately 95% in early-stage tumors to nearly 30% in advanced presentations [5, 6].
+
+Following the diagnosis of head and neck cancer, patients are informed about available therapeutic options, including surgery, chemotherapy, radiotherapy, or combined treatment strategies [7]. Radiotherapy remains one of the most widely employed modalities in contemporary oncologic care and is commonly associated with systemic and oral adverse effects [8]. Head and neck radiotherapy can cause several oral complications, including mucositis, trismus, xerostomia, radiation-associated tooth decay, and osteoradionecrosis (ORN), which can significantly compromise patients’ oral function and quality of life [9, 10]. Radiation-induced caries primarily results from salivary hypofunction, causing alterations in the oral microbiota and impairing biofilm control, which may progress to extensive infectious processes and ultimately require invasive dental interventions, including tooth extraction or endodontic therapy [11].
+
+Currently, tooth extraction prior to radiation therapy is often recommended as a strategy to control odontogenic infections associated with teeth with pulpal and/or periapical disease in these patients. Some narrative studies on mandibular ORN have reinforced that ORN is still a recalcitrant skeletal complication of orofacial cancer radiotherapy that requires adequate clinical planning before therapy [12–14]. Contemporary clinical guidelines, including those issued by the ISOO–MASCC–ASCO, advocate for dental extractions prior to the initiation of radiotherapy in an effort to minimize future complications [15, 16]. Although ORN is a serious radiation-related complication and can be triggered by trauma or surgical procedures on previously irradiated tissues, it is unlikely to develop after an extraction performed before radiotherapy, provided that adequate healing time is ensured before the start of radiotherapy [15, 17].
+
+In non-oncologic patients, endodontic therapy is widely regarded as the treatment of choice for managing oral infectious foci whenever feasible, as it allows preservation of the affected tooth, thereby preventing tooth loss and the subsequent need for prosthetic rehabilitation [16, 18]. Emerging evidence suggests that endodontic therapy may also represent a viable alternative for eliminating odontogenic infectious foci associated with pulpal and/or periapical disease in patients who underwent head and neck radiotherapy [19]. Recent studies have reported favorable clinical outcomes, characterized by high success rates and the absence of ORN, positioning endodontic therapy as a potentially superior approach to tooth extraction, which may be associated with long-term morbidity, the need for complex rehabilitation, and, in certain circumstances, delays in oncologic treatment with potentially life-threatening consequences [20].
+
+Despite advances in oncologic therapies and dental management for head and neck cancer [21, 22], the evidence supporting endodontic therapy in irradiated patients remains fragmented and heterogeneous, particularly with respect to clinical and radiographic outcomes and treatment safety, including the risk of ORN. This uncertainty continues to influence clinical decision-making and often favors more invasive approaches. Therefore, this scoping review aimed to map, characterize, and synthesize the available scientific evidence on the effectiveness and safety of endodontic therapy as a conservative approach for managing odontogenic infectious foci associated with pulpal and/or periapical disease in patients with head and neck cancer who underwent radiotherapy.
+
+Materials and methods
+
+This scoping review was conducted in accordance with the five-stage methodological framework [23], comprising the following: identification of the research question; identification of relevant studies; study selection; data charting; and collation, summarization, and reporting of results. The guiding research question was as follows: “What evidence is available regarding the effectiveness and clinical and radiographic outcomes of endodontic therapy in patients who underwent head and neck radiotherapy?”
+
+The methodological approach was further informed by the Joanna Briggs Institute Manual for Evidence Synthesis [24] and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) [25]. The review protocol was prospectively registered in the Open Science Framework under the registration https://doi.org/10.17605/OSF.IO/T5YNV.
+
+Eligibility criteria
+
+Eligibility criteria were based on the search question, and the PCC strategy used to guide the selection of search terms was as follows: population (patients who underwent radiotherapy to the head and neck region), concept (endodontic therapy), context (assessment of treatment outcomes).
+
+This review included articles involving adult patients diagnosed with head and neck cancer, of any subtype, in whom radiotherapy was the treatment of choice for the disease and who subsequently underwent endodontic therapy. There were no restrictions regarding year of publication, and observational studies, retrospective studies, case reports, and case series were included. Exclusion criteria included in vitro or animal studies, as well as non-original or non-peer-reviewed publications. Studies in which endodontic therapy was performed prior to radiotherapy were also excluded, as the aim of this review was to evaluate the clinical success of endodontic therapy radiotherapy to the head and neck region, as well as the risk of ORN associated with this procedure.
+
+Information sources and search strategy
+
+The following bibliographic databases were used: Medline/PubMed, Embase, Scopus, Web of Science, and LILACS. The gray literature was included using Google Scholar and ProQuest. The search strategy was elaborated on the PubMed platform and adapted to other databases, using the terms: (“Osteoradionecrosis”[MeSH Terms] OR osteoradionecrosis* OR ORN) AND (“Radiotherapy”[MeSH Terms] OR radiotherap* OR irradiation OR radiotherapy-induced) AND (“Endodontics”[MeSH Terms] OR endodontic* OR “Root Canal Therapy”[MeSH Terms] OR root canal*) AND (“Head and Neck Neoplasms”[MeSH Terms] OR “head and neck cancer*” OR “oral cancer*” OR “oropharyngeal neoplasm*”). MeSH terms were also included to broaden the literature search. No limitations regarding language, year, or type of publication were applied to the search. The strategies used for each database are listed in Table 1. Table 1 Search strategy
+
+Database	Search strategy	Filter	
+PubMed	(“Osteoradionecrosis”[MeSH Terms] OR osteoradionecrosis* OR ORN) AND (“Radiotherapy”[MeSH Terms] OR radiotherap* OR irradiation OR radiotherapy-induced) AND (“Endodontics”[MeSH Terms] OR endodontic* OR “Root Canal Therapy”[MeSH Terms] OR root canal*) AND (“Head and Neck Neoplasms”[MeSH Terms] OR “head and neck cancer*” OR “oral cancer*” OR “oropharyngeal neoplasm*”)	No filters applied	
+Scopus	TITLE-ABS-KEY(osteoradionecrosis*) AND TITLE-ABS-KEY(radiotherap* OR irradiation) AND TITLE-ABS-KEY(endodontic* OR “root canal” OR “root canal therapy”) AND TITLE-ABS-KEY(“head and neck cancer*” OR “oral cancer*” OR “oropharyngeal neoplasm*”)	No filters applied	
+Web of Science	TS=(osteoradionecrosis*) AND TS=(radiotherap* OR irradiation) AND TS=(endodontic* OR “root canal” OR “root canal therapy”) AND TS=(“head and neck cancer*” OR “oral cancer*” OR “oropharyngeal neoplasm*”)	No filters applied	
+LILACS	(osteoradionecrosis OR osteorradionecrose) AND (radiotherapy OR radioterapia) AND (endodontics OR endodontia OR “root canal”) AND (“head and neck cancer” OR “neoplasias de cabeça e pescoço” OR “câncer de boca” OR “oral cancer”)	No filters applied	
+Embase	(“osteoradionecrosis”/exp OR osteoradionecrosis* OR ORN) AND (“radiotherapy”/exp OR radiotherap* OR irradiation OR “radiation therapy”) AND (“endodontics”/exp OR endodontic* OR “root canal therapy”/exp OR “root canal”) AND (“head and neck neoplasm”/exp OR “head and neck cancer” OR “oral cancer” OR “oropharyngeal neoplasm”)	No filters applied	
+Google Scholar (gray literature)	(“head and neck” OR “cabeça e pescoço”) AND (“radiation therapy” OR radioterapia) AND (“endodontic treatment” OR “tratamento endodôntico” OR “root canal therapy”) AND (“success rate” OR “treatment outcome” OR “sucesso clínico” OR “sucesso radiográfico”) AND (“thesis” OR “dissertation” OR “teses” OR “dissertação” OR “monografia”)	No filters applied	
+
+Two authors working independently (ASW and WVDS) reviewed the abstract and title of the search results. After searching each database, duplicate studies were removed using Rayyan software [26]. All potentially relevant articles were investigated by reading the full text. If there was a difference of opinion, consensus was reached by consulting a third author (MBR). To assess the agreement between the evaluators for the inclusion of the studies, the kappa coefficient was used [27]. Data extraction was also carried out by the two independent evaluators (ASW and WVDS); differences in results were discussed and resolved by a third evaluator (MBR).
+
+The variables were analyzed using a standardized form including author and year, study design, sample size, radiation dose, timing of radiotherapy, endodontic preparation, irrigant type, obturation technique, sealer type, outcomes, and results.
+
+Outcome assessment
+
+The objective of the review was to identify and characterize the interventions described in the literature regarding endodontic therapy in patients who underwent radiotherapy to the head and neck region. Studies describing endodontic protocols, such as the type of instrumentation used, irrigating solutions, and obturation techniques, were included. In addition, studies reporting radiation dose and the time elapsed after ionizing radiation therapy were considered. Studies that reported clinical outcomes (normalization of the periodontal ligament, periapical stability, and retention of the tooth, as well as the occurrence of ORN), as well as those describing the impact of these interventions on patients’ quality of life and overall well-being, were also included.
+
+Critical appraisal of individual sources of evidence
+
+To characterize the overall strength of the evidence mapped in this scoping review, each included study was classified according to its methodological design using a standardized evidence hierarchy. The evidence quality classification proposed by Stetler et al. [28], based on an adaptation of the Agency for Healthcare Research and Quality (AHRQ) system, was employed. Two reviewers (ASW and MOC) independently classified each included study. The results of this classification were presented narratively and visually to illustrate the distribution of evidence levels in the literature on endodontic interventions in patients who underwent radiotherapy. This analysis was not used to exclude studies but rather to inform the discussion and provide context regarding the robustness of the available evidence.
+
+Results
+
+The electronic search yielded a total of 174 records across the selected databases and sources. Following the removal of duplicate records using the Rayyan QCRI platform and a rigorous screening process, five studies met the eligibility criteria and were included in this scoping review [29–33]. The included evidence comprised three case series [29, 30, 33], one retrospective cohort study [31], and one case report [32]. The study selection process demonstrated a high level of inter-reviewer reliability. Cohen’s kappa coefficients indicated near-perfect agreement between reviewers across databases, with values of 0.86 for PubMed/MEDLINE, 0.80 for Scopus, and 0.87 for the remaining databases.
+
+To facilitate transparency and rapid understanding of the evidence, a PRISMA flowchart summarizing the study selection process was constructed (Fig. 1), and a descriptive table was developed. Table 2 presents a comprehensive synthesis of the included studies, detailing authorship, year of publication, sample characteristics, primary diagnosis and tumor location, radiotherapy technique, radiation dose, timing of radiotherapy, endodontic preparation protocols, irrigation strategies, obturation techniques and obturation cements, and reported clinical outcomes and complications. Table 2 Summary of included studies evaluating the success rate of endodontic treatment and the presence of osteoradionecrosis
+
+Authors (year) (country)	Study design	Sample	Diagnosis/location	Radiotherapy technique	Radiation dose	Timing of radiotherapy	Endodontic technique	Irrigating substance	Obturation technique	Sealer	Outcomes and results	
+Montgomery [32] (USA)	Case report	1 patient (multiple teeth)	Undifferentiated squamous cell carcinoma of the nasopharynx with cervical metastasis	Cobalt 60	5950 rads in the oropharynx; 5904 rads in the nasopharynx; 5490 rads in the cervical region	Years after RT	Manual mechanical preparation	NR	NR	NR	Infection control, no ORN, extractions avoided	
+Markitziu and Heling [29] (Israel)	Case series	2 patients/11 teeth	Case 1, nasopharyngeal carcinoma; Case 2, histiocytic lymphoma in the left tonsil	Case 1: NR; Case 2, cobalt	Case 1, 11,000 rads; Case 2, 7000 rads	Post-RT (2 years and 6 months)	Manual mechanical preparation	Saline solution	Lateral condensation	AH-26	Sucess 2/11 (~ 18%), no ORN, antibiotics prescribed for 5 days	
+Seto et al. [30] (USA)	Case series	16 patients/35 teeth (54 roots)	NR	NR	10 patients, > 6500 rads; 6 patients, 4500 rads and 6500 rads	Post-RT (6–54 months)	NR	NR	Short vs normal/long obturation (length analysis)	NR	85% success (46/54), 0 ORN; short obturation, fewer periapical changes	
+Lilly et al. [31] (USA)	Retrospective cohort	11 patients/22 teeth	10 patients, squamous cell carcinoma; 01 patient, rhabdomyosarcoma	NR	 ≥ 5000 cGy	 ≥ 6 months post-RT, follow-up 19 months	Step-back technique	NR	Lateral condensation	Sealer Grossman	91% success, 0 ORN, normalization PDL	
+Castagnola et al. [33] (Italy)	Contemporary case series	8 patients/10 teeth	3 patients, squamous cell carcinoma (SCC) of the oropharynx; 1 patient, oral SCC; 2 patients, laryngeal SCC; 1 patient, olfactory neuroblastoma	NR	Mean total dose, 66.25 Gy; average periapical dose, 39.36 Gy	137 days after RT (1–282 days)	Rotary ProTaper Next	NaOCl 5,25%, EDTA 17%, saline	Single-cone technique	AH Plus	100% success, 0 ORN, trismus limited clinical access	
+NR not reported
+
+Fig. 1 Flowchart of the search in the database
+
+The included studies predominantly involved patients diagnosed with squamous cell carcinoma affecting the nasopharynx, oropharynx, oral cavity, and larynx. When reported, conventional external beam radiotherapy with Cobalt-60 was employed in older studies, while more recent investigations provided limited technical details but reflected contemporary radiotherapy dose protocols. In general, the data demonstrate that endodontic therapy was performed on teeth located in regions previously exposed to radiotherapy for head and neck tumors, frequently involving anatomical sites considered high-risk for the development of ORN. A synthesis of these clinical findings, including the evolution of endodontic therapy in irradiated patients, the occurrence of ORN, and overall success rates, is illustrated in Fig. 2.Fig. 2 Temporal evolution of endodontic therapy protocols and reported clinical outcomes in patients undergoing head and neck radiotherapy, illustrating the association between protocol optimization and increasing success rates
+
+Clinical and radiographic outcome assessment
+
+Outcome assessment varied among the included studies. Earlier investigations relied predominantly on clinical parameters, such as infection control, symptom resolution, and tooth preservation, due to limitations in radiographic interpretation of irradiated bone [29, 30, 32]. In contrast, more recent studies incorporated combined clinical and radiographic evaluation, including assessment of periodontal ligament normalization and periapical stability [31, 33]. This progression reflects an evolution toward more comprehensive outcome assessment methods in contemporary endodontic practice.
+
+Radiation parameters and treatment timing
+
+Radiation doses ranged from approximately 4500 rads to more than 11,000 rads in earlier studies [29, 30, 32], whereas later investigations reported total doses expressed in gray, including values ≥ 5000 cGy [31] and contemporary protocols of 65–66 Gy with a mean periapical exposure of 39.36 Gy [33]. Endodontic therapy was performed at variable intervals following radiotherapy, ranging from several years after completion [29, 32] to a few months post-radiotherapy [30, 31] and as early as 1 day after completing the treatment [33]. Despite these variations in radiation dose (reported in rads, cGy, or gray) and timing of intervention, none of the included studies reported ORN associated with endodontic therapy, suggesting consistent clinical stability over time (Fig. 3).Fig. 3 Timeline of endodontic treatment outcomes in patients undergoing head and neck radiotherapy across different decades. The figure summarizes key studies from the 1970 s to the 2010 s, highlighting radiation doses, time elapsed after radiotherapy, and the occurrence of osteoradionecrosis (ORN)
+
+Endodontic techniques and clinical outcomes
+
+Endodontic protocols differed substantially across studies. Historically published investigations employed manual instrumentation, limited irrigation strategies, and conventional obturation techniques, resulting in lower or inconsistent success rates (18%) [29, 32]. Seto et al. emphasized apical control during obturation and reported improved outcomes (~ 85%) [30]. With further standardization of endodontic procedures, including step-back preparation, lateral condensation, and the use of appropriate sealers, Lilly et al. [31] reported success rates exceeding 90%. The most recent study, conducted by Castagnola et al. [33], using rotary instrumentation, sodium hypochlorite and EDTA irrigation, and single-cone obturation with epoxy resin–based sealer, reported complete clinical success without cases of ORN.
+
+Critical analysis of the evidence
+
+The studies included in this scoping review predominantly presented a low level of evidence according to the hierarchy proposed by Stetler et al. [28]. There was a predominance of nonexperimental observational designs, including one case report [32] and three case series [29, 30, 33], which correspond to level V evidence. These designs are characterized by descriptive methodology, the absence of control groups, and limited sample sizes. Only one study [31] employed a retrospective cohort design and was therefore classified as level IV evidence. No controlled clinical trials or quasi-experimental studies were identified. This highlights a substantial gap in higher-level evidence regarding the success of endodontic therapy and the risk of ORN in patients who underwent head and neck radiotherapy (Fig. 4).Fig. 4 Classification of the included studies according to levels of evidence based on the system proposed by Stetler et al. (1998)
+
+Discussion
+
+This scoping review synthesized the available evidence on endodontic therapy as a safe and effective treatment option to avoid the extraction of teeth with infectious foci in patients who had previously undergone head and neck radiotherapy. Although the initial search retrieved a substantial number of records, only five studies met the eligibility criteria and were included in the qualitative synthesis [29, 33]. Despite the methodological limitations inherent to the available evidence, the findings suggest that endodontic therapy may represent a viable conservative alternative in previously irradiated patients. Currently, there is insufficient scientific support to routinely recommend tooth extractions based solely on a history of radiotherapy.
+
+The frequency of dental extractions reported during the follow-up of patients who underwent radiotherapy in the head and neck region, associated with the wide variation in the interval between the end of radiotherapy and tooth removal, highlights the cumulative impact of radiation-induced oral complications, as well as limitations in access to specialized dental care [34]. A significant portion of these extractions is related to residual roots, advanced periodontal disease, and extensive radiation-associated caries lesions with pulpal involvement, frequently in patients who did not undergo endodontic therapy due to financial constraints or the unavailability of this procedure in public health services [35, 36]. This scenario reveals a significant mismatch between recommendations based on scientific evidence and daily clinical practice. Dental extractions in previously irradiated bone are recognized as one of the main risk factors for the development of ORN, since surgical trauma can compromise an already hypovascularized area with reduced tissue repair capacity, favoring the occurrence of this complication [37, 38].
+
+In this context, prioritizing endodontic therapy is not only a conservative alternative but also a preventive strategy for potentially serious late complications. By promoting the elimination of odontogenic infection associated with pulpal and/or periapical disease, preserving the structure and function of the affected tooth, controlling painful symptoms, and preserving adjacent soft tissues and bone structures, endodontic therapy may reduce the need for surgical interventions in hypovascularized irradiated bone. Furthermore, it contributes to the maintenance of masticatory function and long-term oral stability in a population already vulnerable to hyposalivation, trismus, and accelerated progression of radiation-related caries [35, 36, 39]. Therefore, expanding access to endodontic therapy, especially in hospitals and the public oncology care network, may reduce the need for tooth extractions and, consequently, mitigate the risk of ORN, aligning clinical practice with contemporary guidelines for supportive oncology care [9, 22, 40].
+
+Early clinical evidence provides important historical context for this therapeutic approach. The case report by Montgomery [32] represents one of the earliest demonstrations of successful endodontic therapy in irradiated tissues. At that time, endodontic therapy was performed under considerably less rigorous protocols, particularly regarding aseptic control, instrumentation, and obturation accuracy. Nevertheless, favorable clinical outcomes were achieved even in the presence of severe radiation-induced oral alterations.
+
+Success criteria varied considerably across the studies. Earlier studies presented definitions that were less standardized or more lenient, regarding periapical stability, the absence of symptoms, or tooth retention as favorable indicators [29, 32]. In contrast, more recent studies applied stricter clinical and radiographic criteria, similar to those used for non-irradiated teeth, including the absence of signs or symptoms, the absence of a sinus tract, the maintenance of the periodontal ligament space, and the absence of periapical lesions [30, 31, 33]. This methodological heterogeneity makes it difficult to directly compare success rates across studies, although none reported ORN associated with endodontic therapy.
+
+The absence of major complications, especially ORN, reported in this and subsequent studies supports the premise that endodontic therapy, when performed with appropriate technical adaptations and strict aseptic control, can be safely conducted in irradiated patients [29, 33]. These findings challenge the routine contraindication of endodontic therapy in irradiated patients and suggest that conservative approaches may represent a safe and clinically feasible option for managing teeth with pulpal and/or periapical disease in this population. Low success rates (approximately 18%) were reported [29], which were attributed to limitations such as imprecise manual instrumentation, saline-only irrigation, and the absence of standardized antibacterial protocols. Despite these constraints, no cases of ORN were observed, suggesting that endodontic therapy itself does not represent a direct risk factor for this complication.
+
+Subsequent studies demonstrated progressively improved outcomes. Seto et al. [30] reported a success rate of approximately 85%, based primarily on clinical criteria, emphasizing the potential role of apical control during obturation in minimizing periapical alterations. With further standardization of endodontic techniques, Lilly et al. [31] reported success rates exceeding 90%, supported by combined clinical and radiographic evaluation. The most recent study included in this review, conducted by Castagnola et al. [33], utilized rotary instrumentation, sodium hypochlorite and EDTA irrigation, and single-cone obturation with an epoxy resin–based sealer, achieving complete clinical success without cases of ORN. Collectively, these findings suggest that modern endodontic protocols may be safely and effectively performed in patients previously treated with head and neck radiotherapy.
+
+Overall, the available evidence indicates that endodontic therapy is both feasible and effective in irradiated patients, particularly when contemporary techniques and standardized protocols are employed [41]. Nevertheless, relevant methodological heterogeneity persists, characterized by a limited number of studies and a wide time span that reveals significant disparities in radiotherapy dosages and endodontic protocols, especially regarding outcome definitions and post-radiotherapy follow-up periods. Only two studies incorporated radiographic assessment [31, 33], reflecting the progressive evolution of methodological rigor in this field. Additional challenges remain regarding the impact of radiotherapy on dentin structure and its implications for endodontic procedures, including sealer adhesion [42]. Accurate diagnosis and minimally invasive approaches remain essential to ensure long-term success and preserve quality of life in patients treated with head and neck radiotherapy.
+
+In this regard, when the endodontic protocol is strictly confined to the apical cemento-dentin-cementum junction, the likelihood of exacerbating periapical infections is drastically minimized, reinforcing the need for technical precision. Cone-beam computed tomography has emerged as a valuable adjunct for treatment planning, enabling three-dimensional assessment of root anatomy and improved detection of periapical alterations [43]. Given the structural changes induced by radiation in dental tissues, endodontic therapy in irradiated patients should be performed in an atraumatic manner to minimize inflammatory responses and optimize prognosis [29, 30]. Although ORN possesses a complex and multifactorial pathophysiology, strongly influenced by factors such as smoking and the oral microbiota profile, the progressive improvement in success rates over time, coupled with the absence of a direct association with ORN, suggests that endodontic therapy may serve as a safe, conservative approach within contemporary supportive cancer care, in accordance with current clinical guidelines [9].
+
+Future studies should also consider anatomical and tooth-related factors that may influence both the risk of ORN and the outcomes of endodontic therapy. The mandible, particularly its posterior region, appears to be more susceptible to ORN than the maxilla; however, current guidelines emphasize that risk assessment should consider the radiation dose and volume received by the specific jaw region rather than anatomical location alone [15]. Therefore, future studies should stratify endodontic outcomes according to tooth location and, whenever possible, incorporate the radiation dose received by the corresponding jaw region. In addition, treatment success should be evaluated according to tooth type and anatomical complexity, particularly distinguishing complex multirooted molars from single- and two-rooted teeth. Such stratification could help clarify whether anatomical location, radiation exposure, and tooth complexity influence the safety and effectiveness of endodontic therapy in previously irradiated patients.
+
+Accurate diagnosis is particularly important before initiating endodontic therapy in previously irradiated patients, as osteoradionecrosis may present with clinical and radiographic findings that overlap with those of odontogenic and periapical diseases, including bone destruction and radiolucent changes [44]. Therefore, radiographic abnormalities should not be interpreted in isolation but rather in conjunction with pulpal and periapical diagnostic tests, clinical findings, and the patient’s history of radiotherapy [44]. When conventional imaging does not provide sufficient information for diagnosis or treatment planning, three-dimensional imaging, such as cone-beam computed tomography (CBCT), may provide additional information regarding the extent and characteristics of periapical and osseous changes [45, 46]. This distinction is clinically relevant because misdiagnosing osteoradionecrosis as a primary endodontic lesion may lead to unnecessary interventions in previously irradiated tissues.
+
+Although direct evidence linking rubber dam clamp trauma to ORN is lacking, caution during clamp placement may be warranted in previously irradiated patients. Gallego et al. reported a case in which trauma associated with a rubber dam clamp during endodontic treatment was considered a potential contributing factor to bisphosphonate-related osteonecrosis of the jaw, suggesting that localized mechanical trauma may represent a potential risk in patients with impaired bone healing [47]. More recently, Gozon et al. described cortical bone erosion and sequestration following the use of a stainless-steel rubber dam clamp during endodontic treatment in an otherwise healthy patient [48]. Although these reports do not directly establish a relationship between rubber dam clamp trauma and ORN, they support the rationale for careful clamp selection and placement in irradiated patients. This consideration may be particularly relevant in irradiated tissues, in which vascular, cellular, and tissue-healing alterations may compromise the response to local trauma. Therefore, the rubber dam clamp should be appropriately selected and positioned atraumatically, with particular attention to avoiding excessive compression or injury to the gingival and periodontal tissues.
+
+The predominance of low-level evidence identified in this scoping review highlights the fragility of the current scientific foundation regarding endodontic therapy outcomes in irradiated patients. Most available data derive from case reports and small case series, which, although clinically valuable and hypothesis-generating, are inherently limited by small sample sizes, the absence of control groups, and restricted external validity. Only one retrospective cohort study [31] was identified, underscoring the scarcity of analytical designs capable of establishing stronger associations between radiotherapy exposure, endodontic management strategies, and the risk of ORN. Moreover, heterogeneity in radiotherapy parameters, particularly regarding dosage, as well as variations in endodontic protocols, outcome definitions, and follow-up periods further limits comparability across studies. Despite these limitations, the consistent absence of ORN associated with ET across the included reports provides clinically reassuring evidence. Nevertheless, well-designed retrospective and prospective cohort studies, along with multicenter investigations with standardized protocols, are urgently needed to strengthen the evidence base and support more definitive clinical recommendations.
+
+Conclusion
+
+The available evidence suggests that endodontic therapy, when performed using contemporary techniques and materials, is consistently associated with favorable clinical outcomes and an absence of reported ORN in the included studies. However, the limited number of studies, the predominance of low-level evidence, and methodological heterogeneity highlight the need for well-designed prospective investigations to reach definitive conclusions regarding the clinical efficacy and safety of this approach, in order to inform the standardization of protocols and strengthen evidence-based clinical decision-making within the context of supportive care in oncology.
+
+Author contributions
+
+Conceptualization: Álvaro de Souza Wanderley and Marlos Barbosa Ribeiro; Methodology: Álvaro de Souza Wanderley,  Lucas Nascimento Ribeiro and Wesley Viana de Sousa; Formal analysis and investigation: Lucas Nascimento Ribeiro, Alícia Marcelly souza de Mendonça Silva, Raylane Farias de Albuquerque, Igor Henrique Morais Silva and Maria Olívia da Costa; Writing - original draft preparation: Álvaro de Souza Wanderley and Wesley Viana de Sousa; Writing - review and editing: Marlos Barbosa Ribeiro, Lucas Nascimento Ribeiro and Diana Santana de Albuquerque; Supervision: Marlos Barbosa Ribeiro and Diana Santana de Albuquerque. All authors have read and agreed to the published version of the manuscript.
+
+Funding
+
+The Article Processing Charge (APC) for the publication of this research was funded by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) (ROR identifier: 00x0ma614). This study was supported by the Academic Strengthening Program of the University of Pernambuco (PFA-UPE) under PROGRAD-05/2025 and PROEC-01/2025. The study also received graduate fellowship support from the Foundation for the Support of Science and Technology of the State of Pernambuco (FACEPE) (PBPG-1842-4.02/25), and from the Coordination for the Improvement of Higher Education Personnel (CAPES), Finance Code 001.
+
+Data availability
+
+In line with Open Science principles, this study is a scoping review and did not generate primary data involving human participants or biological samples. All data analyzed were derived from previously published studies and are available in the public domain. The review was conducted using a rigorous methodology based on established scoping review frameworks and was prospectively registered in the Open Science Framework.
+
+Declarations
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+Sroussi HY, Epstein JB, Bensadoun RJ et al (2017) Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med 6:2918–2931. 10.1002/cam4.1221 29071801 PMC5727249
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+Agurto MG, Bozorgi SS, Carpenter G, Ramirez V, Burke M, Felipe Gutierrez M, Cordova C, Banerjee A (2024) Longitudinal study of the role of salivary proteins on radiation-related caries onset in head and neck cancer patients using 5000 ppm fluoride dentifrice up to one-year post-intensity modulated radiotherapy. Clin Oral Investig 28:379. 10.1007/s00784-024-05788-y 38886263
+12. Bhandari S Wadhwa Soni B Gupta A Ghoshal S Time required for prophylactic oral care in head and neck cancer patients scheduled for radiotherapy: a single center, prospective cohort study Head Neck 2023 45 913 920 10.1002/hed.27317 36794635
+Bhandari S, Wadhwa Soni B, Gupta A, Ghoshal S (2023) Time required for prophylactic oral care in head and neck cancer patients scheduled for radiotherapy: a single center, prospective cohort study. Head Neck 45:913–920. 10.1002/hed.27317 36794635
+13. Singh A Huryn JM Kronstadt KL Yom SK Randazzo JR Estilo CL Osteoradionecrosis of the jaw: a mini review Front Oral Health 2022 10.3389/froh.2022.980786 35967463 PMC9366306
+Singh A, Huryn JM, Kronstadt KL, Yom SK, Randazzo JR, Estilo CL (2022) Osteoradionecrosis of the jaw: a mini review. Front Oral Health. 10.3389/froh.2022.980786 35967463 PMC9366306
+14. Wang Y Turkstani H Alfaifi A Akintoye SO Diagnostic and therapeutic approaches to jaw osteoradionecrosis Diagnostics (Basel) 2024 14 2676 10.3390/diagnostics14232676 39682583 PMC11640485
+Wang Y, Turkstani H, Alfaifi A, Akintoye SO (2024) Diagnostic and therapeutic approaches to jaw osteoradionecrosis. Diagnostics (Basel) 14:2676. 10.3390/diagnostics14232676 39682583 PMC11640485
+15. Peterson DE Koyfman SA Yarom N Lynggaard CD Ismaila N Forner LE Prevention and management of osteoradionecrosis in patients with head and neck cancer treated with radiation therapy: ISOO-MASCC-ASCO guideline J Clin Oncol 2024 42 1975 1996 10.1200/JCO.23.02750 38691821
+Peterson DE, Koyfman SA, Yarom N, Lynggaard CD, Ismaila N, Forner LE et al (2024) Prevention and management of osteoradionecrosis in patients with head and neck cancer treated with radiation therapy: ISOO-MASCC-ASCO guideline. J Clin Oncol 42:1975–1996. 10.1200/JCO.23.02750 38691821
+16. Mercadante V Jensen SB Smith DK Bohlke K Bauman J Brennan MT Salivary gland hypofunction and/or xerostomia induced by nonsurgical cancer therapies: ISOO/MASCC/ASCO guideline J Clin Oncol 2021 39 2825 2843 10.1200/JCO.21.01208 34283635
+Mercadante V, Jensen SB, Smith DK, Bohlke K, Bauman J, Brennan MT et al (2021) Salivary gland hypofunction and/or xerostomia induced by nonsurgical cancer therapies: ISOO/MASCC/ASCO guideline. J Clin Oncol 39:2825–2843. 10.1200/JCO.21.01208 34283635
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+Kovarik PD, Cvek J, Patil R, Macdougall C, Kelly C, Jackson M et al (2024) Timing of development of osteoradionecrosis post head and neck radiotherapy: does a safe time interval exist for dental extraction? Strahlenther Onkol 200:882–894. 10.1007/s00066-024-02251-5 38918259
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+Yanaguizawa WH, Kobayashi-Velasco S, Gialain IO, Caldeira CL, Cavalcanti MGP (2019) Endodontic treatment in patients previously subjected to head and neck radiotherapy. J Oral Diagn 4:1–6. 10.5935/2525-5711.20190001
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+Corrao G, Mazzola GC, Lombardi N, Marvaso G, Pispero A, Baruzzi E et al (2023) Oral surgery and osteoradionecrosis in patients undergoing head and neck radiation therapy: an update of the current literature. Biomedicines 11:3339. 10.3390/biomedicines11123339 38137559 PMC10742198
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+Pfister DG, Spencer S, Adelstein D, Adkins D, Anzai Y, Brizel DM et al (2020) Head and neck cancers, version 2.2020, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 18:873–898. 10.6004/jnccn.2020.0031 32634781
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+Cyr L, Francis K (1992) Measures of clinical agreement for nominal and categorical data: the kappa coefficient. Comput Biol Med 22:239–246. 10.1016/0010-4825(92)90063-S 1643847
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+Stetler CB, Morsi D, Rucki S, Broughton S, Corrigan B, Fitzgerald J et al (1998) Utilization-focused integrative reviews in a nursing service. Appl Nurs Res 11:195–206. 10.1016/S0897-1897(98)80329-7 9852663
+29. Markitziu A Heling I Endodontic treatment of patients who have undergone irradiation of the head and neck Oral Surg Oral Med Oral Pathol 1981 52 294 298 10.1016/0030-4220(81)90269-3 6945540
+Markitziu A, Heling I (1981) Endodontic treatment of patients who have undergone irradiation of the head and neck. Oral Surg Oral Med Oral Pathol 52:294–298. 10.1016/0030-4220(81)90269-3 6945540
+30. Seto BG Beumer J Kagawa T Klokkevold P Wolinsky L Analysis of endodontic therapy in patients irradiated for head and neck cancer Oral Surg Oral Med Oral Pathol 1985 60 540 545 10.1016/0030-4220(85)90245-2 3864116
+Seto BG, Beumer J, Kagawa T, Klokkevold P, Wolinsky L (1985) Analysis of endodontic therapy in patients irradiated for head and neck cancer. Oral Surg Oral Med Oral Pathol 60:540–545. 10.1016/0030-4220(85)90245-2 3864116
+31. Lilly JP Cox D Arcuri M Krell KV An evaluation of root canal treatment in patients who have received irradiation to the mandible and maxilla Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1998 86 224 226 10.1016/S1079-2104(98)90129-9 9720099
+Lilly JP, Cox D, Arcuri M, Krell KV (1998) An evaluation of root canal treatment in patients who have received irradiation to the mandible and maxilla. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 86:224–226. 10.1016/S1079-2104(98)90129-9 9720099
+32. Montgomery S Endodontic complications in an irradiated patient J Endod 1977 3 277 279 10.1016/S0099-2399(77)80048-4 269222
+Montgomery S (1977) Endodontic complications in an irradiated patient. J Endod 3:277–279. 10.1016/S0099-2399(77)80048-4 269222
+33. Castagnola R Minciacchi I Rupe C Marigo L Grande NM Contaldo M The outcome of primary root canal treatment in postirradiated patients: a case series J Endod 2020 46 551 556 10.1016/j.joen.2019.12.005 32088010
+Castagnola R, Minciacchi I, Rupe C, Marigo L, Grande NM, Contaldo M et al (2020) The outcome of primary root canal treatment in postirradiated patients: a case series. J Endod 46:551–556. 10.1016/j.joen.2019.12.005 32088010
+34. de Azevedo LPM Arcoverde R Xavier MGA de Oliveira GRW Martins-de-Barros AV Ribeiro LN Incidence of osteoradionecrosis after dental extractions in head and neck cancer patients: a retrospective cohort study Support Care Cancer 2025 33 1143 10.1007/s00520-025-10192-7 41313370
+de Azevedo LPM, Arcoverde R, Xavier MGA, de Oliveira GRW, Martins-de-Barros AV, Ribeiro LN et al (2025) Incidence of osteoradionecrosis after dental extractions in head and neck cancer patients: a retrospective cohort study. Support Care Cancer 33:1143. 10.1007/s00520-025-10192-7 41313370
+35. Nabil S Samman N Incidence and prevention of osteoradionecrosis after dental extraction in irradiated patients: a systematic review Int J Oral Maxillofac Surg 2011 40 229 243 10.1016/j.ijom.2010.10.005 21115324
+Nabil S, Samman N (2011) Incidence and prevention of osteoradionecrosis after dental extraction in irradiated patients: a systematic review. Int J Oral Maxillofac Surg 40:229–243. 10.1016/j.ijom.2010.10.005 21115324
+36. Goh EZ Beech N Johnson NR Batstone M The dental management of patients irradiated for head and neck cancer Br Dent J 2023 234 800 804 10.1038/s41415-023-5864-z 37291302 PMC10250190
+Goh EZ, Beech N, Johnson NR, Batstone M (2023) The dental management of patients irradiated for head and neck cancer. Br Dent J 234:800–804. 10.1038/s41415-023-5864-z 37291302 PMC10250190
+37. Barbosa CR Simonato LE Manejo terapêutico e preventivo da osteorradionecrose Revista Ibero-Americana de Humanidades, Ciências e Educação 2022 8 1893 1904 10.51891/rease.v8i4.5341
+Barbosa CR, Simonato LE (2022) Manejo terapêutico e preventivo da osteorradionecrose. Revista Ibero-Americana de Humanidades, Ciências e Educação 8:1893–1904. 10.51891/rease.v8i4.5341
+38. Pereira I Firmino R Meira H Vasconcelos B Noronha V Santos V Osteoradionecrosis prevalence and associated factors: a ten years retrospective study Med Oral Patol Oral Cir Bucal 2018 10.4317/medoral.22310 30341256 PMC6260996
+Pereira I, Firmino R, Meira H, Vasconcelos B, Noronha V, Santos V (2018) Osteoradionecrosis prevalence and associated factors: a ten years retrospective study. Med Oral Patol Oral Cir Bucal. 10.4317/medoral.22310 30341256 PMC6260996
+39. De Mattos FPS Marchionni AMT Endodontia e sepultamento radicular como tratamento conservador em paciente submetido à radioterapia: relato de caso / Endodontics and burial root as a conservative treatment in undergone radiotherapy patient: case report Braz J Dev 2021 7 114300 114314 10.34117/bjdv7n12-284
+De Mattos FPS, Marchionni AMT (2021) Endodontia e sepultamento radicular como tratamento conservador em paciente submetido à radioterapia: relato de caso / Endodontics and burial root as a conservative treatment in undergone radiotherapy patient: case report. Braz J Dev 7:114300–114314. 10.34117/bjdv7n12-284
+40. Watson E Dorna Mojdami Z Oladega A Hope A Glogauer M Clinical practice guidelines for dental management prior to radiation for head and neck cancer Oral Oncol 2021 123 105604 10.1016/j.oraloncology.2021.105604 34775180
+Watson E, Dorna Mojdami Z, Oladega A, Hope A, Glogauer M (2021) Clinical practice guidelines for dental management prior to radiation for head and neck cancer. Oral Oncol 123:105604. 10.1016/j.oraloncology.2021.105604 34775180
+41. Pauletto G Voigt GIM de Pellegrin SF Padoin Y Bier CAS The impact of radiotherapy on endodontic treatment: a scoping review Odontology 2026 114 24 42 10.1007/s10266-025-01139-9 40616631
+Pauletto G, Voigt GIM, de Pellegrin SF, Padoin Y, Bier CAS (2026) The impact of radiotherapy on endodontic treatment: a scoping review. Odontology 114:24–42. 10.1007/s10266-025-01139-9 40616631
+42. Paiola F Lopes FC Mazzi-Chaves JF Pereira RD Oliveira HF Queiroz A Queiroz AMd Sousa-Neto MDd How to improve root canal filling in teeth subjected to radiation therapy for cancer Braz Oral Res 2018 10.1590/1807-3107bor-2018.vol32.0121 30517430
+Paiola F, Lopes FC, Mazzi-Chaves JF, Pereira RD, Oliveira HF, Queiroz A, Queiroz AMd, Sousa-Neto MDd (2018) How to improve root canal filling in teeth subjected to radiation therapy for cancer. Braz Oral Res. 10.1590/1807-3107bor-2018.vol32.0121 30517430
+43. Patel S Brown J Pimentel T Kelly RD Abella F Durack C Cone beam computed tomography in Endodontics—a review of the literature Int Endod J 2019 52 1138 1152 10.1111/iej.13115 30868610
+Patel S, Brown J, Pimentel T, Kelly RD, Abella F, Durack C (2019) Cone beam computed tomography in Endodontics—a review of the literature. Int Endod J 52:1138–1152. 10.1111/iej.13115 30868610
+44. Ma JZ Tay FR Endodontic management before, during and after head and neck radiotherapy: biological, diagnostic and clinical considerations in head and neck cancer patients Int Endod J 2026 10.1111/iej.70193 42246090
+Ma JZ, Tay FR (2026) Endodontic management before, during and after head and neck radiotherapy: biological, diagnostic and clinical considerations in head and neck cancer patients. Int Endod J. 10.1111/iej.70193 42246090
+45. Patel S Brown J Semper M Abella F Mannocci F European Society of Endodontology position statement: use of cone beam computed tomography in endodontics Int Endod J 2019 52 1675 1678 10.1111/iej.13187 31301231
+Patel S, Brown J, Semper M, Abella F, Mannocci F (2019) European Society of Endodontology position statement: use of cone beam computed tomography in endodontics. Int Endod J 52:1675–1678. 10.1111/iej.13187 31301231
+46. Melo SLS Fayad MI Gohel A Johnson BR Kalathingal S Mahdian M Nair M Setzer FC Makins SR AAE and AAOMR joint position statement: use of cone-beam computed tomography in endodontics 2025 update J Endod 2026 52 4 13 10.1016/j.joen.2025.09.008 41412684
+Melo SLS, Fayad MI, Gohel A, Johnson BR, Kalathingal S, Mahdian M, Nair M, Setzer FC, Makins SR (2026) AAE and AAOMR joint position statement: use of cone-beam computed tomography in endodontics 2025 update. J Endod 52:4–13. 10.1016/j.joen.2025.09.008 41412684
+47. Gallego L, Junquera L, Pelaz A, Díaz-Bobes C (2011) Rubber dam clamp trauma during endodontic treatment: a risk factor of bisphosphonate-related osteonecrosis of the jaw? J Oral Maxillofac Surg e95. 10.1016/j.joms.2010.06.197 21211886
+48. Gozon R Rumford F Cervenka P Rubber dam clamp may cause cortical necrosis: a case report J Endod 2023 49 604 608 10.1016/j.joen.2023.03.003 36914022
+Gozon R, Rumford F, Cervenka P (2023) Rubber dam clamp may cause cortical necrosis: a case report. J Endod 49:604–608. 10.1016/j.joen.2023.03.003 36914022
diff --git a/corpus/healthcare/text/a7b0f03e55884174.txt b/corpus/healthcare/text/a7b0f03e55884174.txt
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@@ -0,0 +1,348 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Cureus
+Journal ID: Cureus
+NLM Journal ID: 101596737
+
+Cureus
+
+EISSN: 2168-8184
+Publisher: Cureus Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13032184
+PMID: 41909441
+DOI: 10.7759/cureus.104278
+Article version: 1
+Subjects: Epidemiology/Public Health, Public Health
+
+Barriers to Healthcare Access and Utilization Among Immigrants in Host Countries: A Systematic Review of Qualitative and Quantitative Evidence
+
+Muacevic Alexander
+Adler John R
+Krupić Ferid 1
+Krupić Melissa 2
+Sahra Saidarab 3 4
+Dervišević Emina 5
+Seffo Nail 1
+Alić Jasmin 6
+1 Department of Anaesthesiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SWE
+2 Department of Gynaecology, Sahlgrenska University Hospital/Östra, Gothenburg, SWE
+3 Department of Maternity Care, Sahlgrenska University Hospital, Gothenburg, SWE
+4 Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SWE
+5 Department of Forensic Medicine, University of Sarajevo, Faculty of Medicine, Sarajevo, BIH
+6 Urology Clinic, Clinical Center University of Sarajevo, Sarajevo, BIH
+Jasmin Alić jasmin.allic@gmail.com
+Electronic publication date: 2026 Feb 26
+Publication date: 2026 Feb
+Volume: 18
+Issue: 2
+Electronic Location ID: e104278
+Accepted 2026 Feb 25
+Copyright: Copyright © 2026, Krupić et al.
+Copyright year: 2026
+Copyright holder: Krupić et al.
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+This article is available from https://cureus.com/articles/456076-barriers-to-healthcare-access-and-utilization-among-immigrants-in-host-countries-a-systematic-review-of-qualitative-and-quantitative-evidence
+Keywords: access to healthcare, cultural competency, emigrants and immigrants, healthcare access disparity, health services accessibility, language barrier
+
+Ÿ==============================Ÿ
+Immigrant populations frequently encounter barriers when accessing healthcare services, potentially affecting patient safety, healthcare utilization, and clinical outcomes. Understanding these barriers is essential for improving equitable and patient-centered care. 
+
+A systematic review of qualitative and quantitative studies was conducted in accordance with PRISMA 2020 guidelines. PubMed/MedLINE, Embase, Cochrane Library, PsycINFO, EconLit, Web of Science (WoS), and CINAHL were searched from January 2005 to August 2023. Inductive thematic analysis was used to synthesize findings across studies. The review was not prospectively registered, included only English-language studies, and relied predominantly on qualitative evidence. Heterogeneity across study designs and healthcare settings may limit generalizability. The authors received no external funding for this study.
+
+Three interconnected themes consistently emerged: limited transcultural competence, language barriers, and discrimination in healthcare. Inadequate cultural competence was associated with communication difficulties and reduced care effectiveness. Language barriers contributed to miscommunication, delayed care, and increased healthcare utilization. Experiences of discrimination were linked to reduced trust in healthcare systems and poorer patient engagement. These factors negatively influenced patient safety, satisfaction, and clinical outcomes.
+
+Immigrant patients face persistent and interrelated barriers to healthcare access. Strengthening culturally responsive care, improving access to professional interpreter services, and addressing discriminatory practices are essential to improving patient safety, satisfaction, and clinical outcomes. Future research should evaluate targeted interventions aimed at improving communication, cultural competence, and healthcare equity.
+
+Introduction and background
+
+Migration occurs for multiple reasons, including security concerns, demographic pressures, human rights issues, poverty, and climate change. According to Eurostat, as of January 1, 2021, approximately 23.7 million third-country nationals were residing in the European Union (EU), representing 5.3% of the total EU population [1]. Migration may be voluntary or forced and is commonly driven by economic, environmental, and social factors. These movements are influenced by push factors, which compel individuals to leave their country of origin, and pull factors, which attract them to a specific destination country [2]. Broadly, migration is motivated by social and political circumstances, demographic and economic conditions, and environmental or climate-related changes [1,2].
+
+In addition to economic and voluntary migration, armed conflicts and political instability remain major drivers of global displacement. Individuals forced to migrate due to war often face increased health vulnerability, including trauma, disrupted continuity of care, language barriers, and limited familiarity with healthcare systems in host countries [3]. These factors may contribute to delayed healthcare access, unmet medical needs, and poorer health outcomes. Recognizing the healthcare challenges faced by conflict-affected migrants is important for developing equitable and responsive healthcare services [3,4].
+
+Following migration, individuals retain their legal rights and responsibilities in the host country. One fundamental right, irrespective of country of origin, is access to healthcare and medical services. Increasing global migration has contributed to growing multiculturalism, placing new and complex demands on healthcare systems [1,2]. Encounters between healthcare professionals and patients with an immigrant background often involve specific challenges, and ensuring equitable, high-quality care remains a core professional responsibility [4]. Achieving this goal requires culturally responsive healthcare environments and healthcare professionals with adequate transcultural competence [5].
+
+Previous research has consistently reported barriers and difficulties faced by immigrants when accessing healthcare services. A key contributor to health disparities between immigrant and native populations is delayed healthcare-seeking behavior among immigrants, resulting in later utilization of health services compared with native residents [6-8]. These differences raise important questions regarding the underlying causes of delayed care-seeking. Documented contributing factors include ethnicity, socioeconomic status, and cultural influences on healthcare interactions [9-11]. Additional factors such as immigrant status, marital status, age, gender, number of children, income, and educational level further influence healthcare utilization [12]. Language barriers, including limited proficiency in the host-country language and challenges related to interpreter services, have also been widely reported [13-15]. In some cases, delayed or inadequate use of healthcare services has been associated with increased mortality among immigrant populations [16,17]. Transcultural competence among healthcare professionals was identified as an important factor influencing the quality of care for immigrant patients [18-27].
+
+Despite growing recognition of healthcare disparities among immigrant populations, existing research remains fragmented across qualitative and quantitative domains, often focusing on isolated determinants such as communication barriers [4,5,8-10], cultural differences [26,28-40], or discrimination [41-47]. Few studies have comprehensively synthesized these interrelated factors across diverse healthcare systems and settings, limiting the ability to draw broader conclusions about systemic barriers affecting immigrant patients [6,7,11].
+
+The objective of this systematic review was to identify and synthesize available qualitative and quantitative evidence on the barriers faced by immigrant patients in accessing and receiving healthcare in host countries. Specifically, this review aimed to examine how cultural competence, language barriers, and discrimination influence healthcare experiences, access, and outcomes among immigrant populations.
+
+The review was guided by the following research question: Among immigrant populations, what barriers influence access to and utilization of healthcare services in host countries, and how do these barriers affect patient experiences and healthcare outcomes?
+
+Review
+
+Methods
+
+This systematic review was conducted in accordance with the PRISMA 2020 (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines [18]. Given the aim of the study to explore factors influencing individuals’ experiences and decision-making processes, qualitative studies were considered particularly suitable. Qualitative methodology enables in-depth exploration of lived experiences and perceptions, which aligns with the objective of identifying factors that shape healthcare-related decisions among individuals [19].
+
+Selection and Eligibility Criteria
+
+The initial selection strategy was developed in consultation with an information specialist at the University Library of Gothenburg. Following this consultation, two authors independently conducted the literature search and study selection. 
+
+Studies were considered eligible if they investigated immigrants’ or migrants’ experiences in accessing or utilizing healthcare services. We included qualitative, quantitative, and mixed-methods studies published in peer-reviewed journals, available in full text, and written in English within the predefined time frame (between January 2005 and August 2023). English was used due to resource constraints. The date range reflects the modern era of increased global migration and evolving healthcare policies. Mixed-methods studies and systematic reviews were excluded. Studies involving adult populations (≥18 years) were eligible. To be included, studies had to address at least one of the following domains: transcultural competence, communication and language barriers, discrimination in healthcare, access to healthcare services, or quality of care.
+
+We excluded review articles, editorials, commentaries, case reports, and conference abstracts without full text. Studies that did not distinguish immigrant populations from the general population, as well as those lacking sufficient methodological detail, were excluded. Non-English publications, duplicate records, and gray literature were also excluded. Additionally, studies focusing exclusively on epidemiological data without examining patient experience or interaction with healthcare systems were not considered eligible.
+
+In accordance with a PICO-informed framework, the population of interest included immigrant patients, the exposure involved healthcare access and utilization, comparisons (where applicable) included native populations or differing healthcare contexts, and outcomes included patient experiences, barriers, and healthcare-related outcomes.
+
+Literature Search Strategy
+
+Search terms were developed using SweMeSH to enhance precision and relevance. The primary keywords, followed by secondary in parenthesis, included "healthcare access disparities" ("health services accessibility", "healthcare access", "health care utilization", "access to healthcare", "barriers to healthcare", "healthcare disparities"), "immigrants" ("migrants", "emigrants", "refugees"), "language barriers" ("communication barriers", "language barriers", "interpreter services", "health communication"), "cultural competency" ("cultural competence", "transcultural care", "cross-cultural care", "culturally competent care"), "discrimination" ("healthcare discrimination", "inequality", "health inequities"). These terms were combined using the Boolean operator AND, while the operator OR was used for the inclusion of secondary keywords. MeSH terms and free-text keywords related to community, healthcare access, and influencing factors were integrated into the search strategy. Searches were conducted in PubMed/MedLINE, Cocrane Library, CINAHL, Embase, Web of Science (WoS), PsycINFO, and EconLit. In addition, reference lists of relevant studies and reviews were manually screened (Table 1).
+
+Table 1 Results of database searches
+
+Database	Hits	
+PubMed/MedLINE	255	
+Cocrane Library	134	
+Embase	98	
+Others	64	
+Total	551	
+
+Titles of all identified studies were initially reviewed, followed by abstract screening. Articles whose abstracts were deemed relevant to the study aim were retrieved in full text. Of the 45 full-text articles assessed, 15 studies met the inclusion criteria and were included in the final analysis.
+
+Data Analysis
+
+All authors independently screened abstracts and full-text articles for eligibility. The included studies were analyzed using a five-step thematic analysis model [21]. First, all authors read the selected studies with particular emphasis on the Results section. Key findings were then identified, after which similarities and differences across studies were compared. Data extraction and organization were performed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). The software was used to structure extracted variables, perform descriptive data handling, and generate summary tables. These comparisons informed the development of new themes and subthemes. In the final step, an integrated synthesis was constructed, with the identified themes and subthemes forming the basis for the Results section. Discrepancies were discussed among all authors until consensus was reached.
+
+Risk-of-Bias Assessment
+
+The methodological quality and risk of bias of the included studies were assessed using validated tools appropriate to the study design. Qualitative studies were evaluated using the Critical Appraisal Skills Programme (CASP) Qualitative Checklist, while observational quantitative studies were assessed using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool.
+
+Each study was independently appraised across relevant domains, and an overall judgment was assigned. This structured approach enabled transparent evaluation of methodological quality across heterogeneous study designs and supported interpretation of the findings.
+
+Ethical Considerations
+
+Ethical aspects of all included studies were carefully reviewed. All studies adhered to established research ethics guidelines, including informed consent obtained verbally and in writing from participants, voluntary participation, confidentiality of data, and approval from appropriate ethics committees. Participants in the original studies were informed of their right to withdraw at any time without consequences, and all collected data were used solely for research purposes.
+
+Results
+
+Literature Search and Study Selection
+
+The study selection process was conducted in accordance with PRISMA 2020 guidelines [18]. Database searches identified a total of 551 records, with no additional records identified through manual searching of reference lists and other sources. After removal of 326 duplicates, 225 records remained for title and abstract screening.
+
+Following initial screening, 180 articles were excluded for not meeting the inclusion criteria. The full texts of 45 potentially eligible studies were retrieved and assessed for eligibility. Of these, 30 studies were excluded due to reasons such as irrelevance to the study objective, insufficient methodological quality, lack of focus on immigrant populations, or absence of relevant outcomes.
+
+Ultimately, 15 studies met the inclusion criteria and were included in the final qualitative and quantitative synthesis. The detailed study selection process is presented in the PRISMA flow diagram (Figure 1). Publications spanned from 2005 to 2023, with data predominantly collected through semi-structured interviews and focus group discussions. 
+
+Figure 1 PRISMA guidelines
+
+PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
+
+A total of 15 studies were included in the final synthesis, comprising both qualitative and quantitative designs (Table 2). The majority of included studies were qualitative, primarily using semi-structured interviews to explore experiences of immigrant patients and healthcare professionals, while two studies employed quantitative survey methodologies [4,37]. Sample sizes varied across studies, reflecting differences in study design and methodological approach.
+
+Table 2 Characteristics, limitations, thematic domain, and risk of bias of included studies
+
+NR = not reported; CASP = Critical Appraisal Skills Programme, ROBINS-I = Risk Of Bias In Non-randomized Studies of Interventions.
+
+Author (Year)	Country	Study Design	Sample Size	Population	Key Findings	Study Limitations	Primary Theme	Quality Appraisal Tool	Overall Risk of Bias	
+Kjøllesdal et al. (2020) [4]	Norway	Quantitative	NR	Immigrant patients	Lower satisfaction and delayed healthcare utilization	Self-reported data; cross-sectional design	Language barrier	ROBINS-I	Moderate	
+Krupic et al. (2016) [15]	Sweden	Qualitative	30	Immigrants	Interpreter-related language barriers	Small sample; qualitative design	Language barrier	CASP	Low	
+Amiri et al. (2015) [23]	Iran	Qualitative	18	Healthcare professionals	Insufficient transcultural competence	Small sample; subjective reporting	Transcultural incompetence	CASP	Low	
+Plaza Del Pino et al. (2013) [26]	Spain	Qualitative	12	Moroccan patients	Cultural misunderstanding and communication gaps	Small sample; cultural specificity	Transcultural incompetence	CASP	Low	
+Mangrio and Persson (2017) [31]	Sweden	Qualitative	14	Immigrant parents	Language barriers in child healthcare	Recall bias; small sample	Language barrier	CASP	Low	
+Aelbrecht et al. (2016) [29]	Belgium	Qualitative	22	Immigrant cancer patients	Poor communication and unmet informational needs	Disease-specific population	Language barrier	CASP	Low	
+Bachmann et al. (2014) [32]	Germany	Qualitative	15	Russian-speaking migrants	Miscommunication and mistrust	Limited representativeness	Language barrier	CASP	Low	
+Anoosheh et al. (2009) [36]	Iran	Qualitative	21	Nurses	Communication barriers causing stress	Self-reported data	Language barrier	CASP	Moderate	
+Biyikli Gültekin (2017) [37]	Austria	Quantitative	384	Turkish immigrants	Delayed access and dissatisfaction	Cross-sectional design	Language barrier	ROBINS-I	Moderate	
+Hunter-Adams and Rother (2017) [38]	South Africa	Qualitative	32	Immigrant patients	Language barriers impairing care quality	Context-specific findings	Language barrier	CASP	Low	
+Straiton and Myhre (2017) [40]	Norway	Qualitative	16	Immigrants	Navigational barriers in healthcare system	Small sample	Language barrier	CASP	Low	
+Smith and Ruston (2013) [41]	United Kingdom	Qualitative	20	Roma patients	Discrimination and healthcare avoidance	Self-reported experiences	Discrimination	CASP	Moderate	
+Ahrne et al. (2019) [42]	Sweden	Qualitative	24	Somali women	Perceived discrimination in antenatal care	Population-specific	Discrimination	CASP	Low	
+Reid and Taylor (2007) [43]	United Kingdom	Qualitative	19	Traveler women	Negative maternity care experiences	Small sample; cultural specificity	Discrimination	CASP	Moderate	
+Abdu et al. (2016) [44]	United Kingdom	Qualitative	17	South Asian families	Lack of culturally adapted counselling	Limited generalizability	Transcultural incompetence	CASP	Low	
+
+The included studies were conducted across diverse geographical regions, including Europe (Norway, Sweden, Spain, Belgium, Germany, Austria, and the United Kingdom), as well as Iran and South Africa, enhancing the contextual breadth and transferability of findings and providing limited but relevant perspectives from non-European settings (Table 2). Study populations included immigrant patients, healthcare professionals, and specific subgroups such as immigrant parents, migrant women, and ethnic minority families.
+
+Across studies, three consistent thematic domains were identified. Language and communication barriers were frequently reported and were associated with miscommunication, delayed healthcare access, reduced satisfaction, and impaired quality of care [4,15,29,31,32,36-39,40]. Limited transcultural competence among healthcare professionals was identified as a contributing factor to communication challenges, professional frustration, and difficulties in delivering culturally responsive care [23,26,44]. Experiences of discrimination and differential treatment were also commonly described and were associated with mistrust, negative healthcare experiences, and avoidance of healthcare services [41-43].
+
+Despite variations in study design, population characteristics, and healthcare settings, the consistency of findings across studies supports the robustness of the identified themes and suggests that barriers to healthcare access among immigrant populations are systemic rather than context-specific. Characteristics, key findings, limitations, thematic domain, and risk of bias of included studies are presented in Table 2.
+
+Thematic analysis of the included studies identified three overarching themes: (i) transcultural competence, (ii) language deficiencies, and (iii) discrimination in healthcare. 
+
+Transcultural Competence
+
+Across the included studies, transcultural competence among healthcare professionals emerged as a central factor influencing the quality of care provided to immigrant patients. Healthcare professionals consistently emphasized the importance of knowledge in transcultural care, continuous education, and heightened awareness when caring for patients from diverse cultural backgrounds. Training focused on humanistic values, respect, empathy, patient rights, and effective communication was highlighted as essential for delivering high-quality care [4,23].
+
+Several studies reported that insufficient transcultural competence contributed to professional frustration and feelings of inadequacy among healthcare staff when caring for immigrant patients [23]. Challenges were particularly pronounced when cultural differences intersected with language barriers, resulting in communication breakdowns and fragmented care processes. In such situations, care that failed to incorporate cultural understanding was often perceived as inadequate by patients [24]. To address these challenges, multiple studies advocated for structured and continuous training in transcultural care to enhance professionals’ ability to understand patients’ health beliefs and behaviors within a cultural context [25,26]. However, previous research indicates that formal education in transcultural care remains limited during professional training, leaving healthcare staff insufficiently prepared [27].
+
+Language Deficiencies
+
+Language barriers were consistently described as a major obstacle to effective healthcare delivery and were reported from both patient and healthcare professional perspectives. Studies identified two primary dimensions of this issue: communication challenges faced by healthcare staff and adverse consequences for patients with limited proficiency in the host-country language [28]. Immigrant patients frequently identified language barriers as a key impediment to receiving satisfactory healthcare [29,30], with poor bidirectional communication negatively affecting patient-provider interactions [29,31].
+
+Consequences of inadequate communication included reduced self-confidence, increased fear and anxiety, and uncertainty regarding medical information, sometimes leading patients to guess the meaning of clinical instructions [31-33]. Inadequate understanding was associated with misdiagnosis, incorrect medication use, and premature discontinuation of treatment [30,34]. From the healthcare professionals’ perspective, communication difficulties led to avoidance of interactions with immigrant patients, contributing to anxiety, self-doubt, and concerns about providing suboptimal care [35].
+
+Language barriers also increased workload and time demands for staff, exacerbating stress in already resource-constrained healthcare settings. Patients with limited language proficiency were more likely to receive incomplete information, struggle to follow treatment recommendations, make frequent emergency department visits, undergo more diagnostic testing, and report greater dissatisfaction with care [23,36-38]. Although interpreter services were introduced as a mitigating strategy, several studies indicated that these services were not always sufficient to fully address communication challenges [39,40]. Cultural factors further compounded language-related difficulties, including perceived lack of empathy, ignored patient questions, and mistrust toward healthcare professionals, ultimately contributing to delayed care-seeking and worsened health outcomes [15,37-39].
+
+Discrimination in Healthcare
+
+Discrimination against immigrant patients was reported across multiple studies and manifested in several forms, including prejudice, lower prioritization of care, and differential treatment. One study from England focusing on Roma patients described experiences of prejudice and discrimination that negatively affected psychological well-being, social withdrawal, and reluctance to seek healthcare [41]. Other studies similarly found that perceived prejudice increased vigilance and reduced healthcare utilization, particularly when patients encountered discriminatory or stigmatizing remarks from healthcare providers [42].
+
+Discriminatory experiences also extended to perceptions of immigrant children being viewed as more disruptive in waiting rooms and negative attitudes toward family size among immigrant families [42,43]. In home healthcare settings, participants reported that standardized counseling approaches disregarded their cultural parenting practices, leaving them feeling misunderstood and undervalued [44]. Lower prioritization of care was frequently described, with participants perceiving that their ethnicity influenced the timeliness and quality of care received, particularly when compared with native-born or White patients [45]. Such experiences fostered fear of stigmatization and further discouraged healthcare-seeking behavior.
+
+Experiences of special or differential treatment based on ethnicity, skin color, or religion were also reported. These included lack of attention, intrusive curiosity regarding bodily differences, and stereotyping of non-White patients. Although some participants minimized these encounters, such experiences contributed to feelings of alienation and reinforced perceptions of unequal treatment within healthcare systems [46,47].
+
+Overall, the included studies demonstrated predominantly low to moderate risk of bias (Table 2). Methodological limitations were mainly related to participant selection and reporting transparency, which are common in qualitative and observational research designs. 
+
+Discussion
+
+Summary of Main Findings
+
+This systematic review synthesized qualitative and quantitative evidence to identify the most common barriers encountered by immigrant patients when accessing healthcare services. Using Friberg’s five-step analytical framework [21], three interrelated themes consistently emerged: transcultural competence, language barriers, and discrimination in healthcare. The convergence of findings across geographically diverse studies strengthens the credibility and transferability of the results and suggests that these barriers are systemic rather than context-specific.
+
+Interpretation in the Context of Existing Literature
+
+Transcultural competence was consistently identified as a prerequisite for safe, respectful, and effective healthcare delivery. Healthcare professionals emphasized the importance of empathy, cultural awareness, and continuous education when caring for patients from diverse backgrounds [23-27]. Conversely, insufficient transcultural knowledge was associated with professional frustration, communication breakdowns, and reduced ability to provide culturally appropriate care [23-27]. Previous studies have similarly demonstrated that culturally responsive care improves patient engagement and healthcare effectiveness, although cultural differences may sometimes influence treatment acceptance [48]. Active patient participation and culturally sensitive dialogue were shown to facilitate individualized and context-adapted care planning [49].
+
+Language barriers emerged as one of the most significant obstacles to effective healthcare delivery. Ineffective communication negatively affected patient-provider interactions, reduced patient confidence, and increased anxiety [28-32]. Healthcare professionals reported increased stress and fear of clinical errors when communication was inadequate, often relying on assumptions or incomplete information. Consequences included miscommunication, compromised care quality, increased emergency department utilization, higher diagnostic testing rates, and reduced patient satisfaction [33-37]. Delays in interpreter access, misunderstanding of medical information, and difficulties navigating healthcare systems were frequently reported [50,51]. Similar findings observed among internally displaced populations suggest that communication barriers reflect broader systemic challenges in healthcare access rather than issues unique to international migration [52].
+
+Discrimination against immigrant patients was frequently described and manifested through prejudicial attitudes, differential treatment, and lower prioritization of care [42-45]. Patients reported feeling undervalued, stigmatized, or treated as less deserving of care. Discriminatory experiences, including stereotyping and differential attention based on ethnicity, religion, or cultural background, contributed to mistrust and reluctance to seek healthcare [46,47]. Such practices were associated with reduced trust in healthcare systems and potential adverse health outcomes [53], contradicting fundamental ethical and legal principles of equality and patient-centered care [54-56].
+
+Implications for Clinical Practice, Policy, and Research
+
+From a clinical perspective, integrating structured transcultural competence training into medical and nursing curricula, with measurable evaluation components, may improve culturally responsive care and strengthen patient-provider communication. Ensuring timely and reliable access to professional interpreter services is essential for safe clinical decision-making and reducing preventable errors. At the policy level, healthcare institutions should implement monitoring and accountability frameworks to identify and address discriminatory practices and promote equitable healthcare delivery.
+
+Future research should focus on evaluating targeted interventions, including transcultural competence training, interpreter services, and anti-discrimination programs, with emphasis on measurable clinical outcomes, patient safety, and healthcare utilization. Longitudinal and comparative studies are needed to assess the impact of structural and policy-level interventions on healthcare equity and patient outcomes.
+
+Strengths and Limitations
+
+A major strength of this study is the systematic synthesis of both qualitative and quantitative research, allowing for a comprehensive understanding of immigrant patients’ experiences within healthcare systems. The inclusion of studies from multiple geographical regions enhances the transferability of the findings and suggests that the identified challenges are not confined to specific healthcare settings or countries.
+
+The use of an established analytical framework (Friberg’s model) provided a structured and transparent approach to data synthesis, strengthening the methodological rigor of the analysis. Furthermore, adherence to PRISMA guidelines improved the transparency and reproducibility of the review process [21]. The identification of consistent themes across diverse contexts reinforces the credibility of the results and supports their relevance to international healthcare systems.
+
+Several limitations should be considered when interpreting the findings of this review. First, although both qualitative and quantitative studies were included, the synthesis relied predominantly on qualitative evidence. While qualitative research provides rich contextual insight into patient experiences and healthcare interactions, it limits the ability to establish causal relationships, quantify effect sizes, or assess the magnitude of associations between identified barriers and clinical outcomes. Consequently, the findings should be interpreted as explanatory and hypothesis-generating rather than confirmatory.
+
+Second, the inclusion of only English-language publications may have introduced language bias and led to the exclusion of relevant studies conducted in non-English-speaking settings. This limitation is particularly important, given that migration and healthcare access are global phenomena, and perspectives from regions where English is not the primary academic language may be underrepresented. As a result, the transferability of findings to certain cultural and healthcare contexts may be limited.
+
+Third, substantial heterogeneity was observed across included studies with respect to study design, populations, healthcare systems, and outcome measures. Differences in immigration status, socioeconomic background, healthcare infrastructure, and policy environments may have influenced reported experiences and outcomes. This heterogeneity limits direct comparability between studies and precludes quantitative synthesis, potentially affecting the consistency and generalizability of conclusions.
+
+Fourth, many included studies relied on self-reported patient or provider experiences, introducing potential recall bias, reporting bias, and subjective interpretation. Perceptions of discrimination, communication barriers, and cultural competence may vary depending on individual expectations, cultural norms, and prior healthcare experiences, which may influence the reliability and comparability of reported findings.
+
+Fifth, variability in the conceptualization and measurement of key constructs, such as transcultural competence, language barriers, and discrimination, across studies may have affected thematic synthesis and interpretation. Differences in definitions, measurement tools, and analytical approaches may introduce interpretive variability and limit the precision of cross-study comparisons.
+
+Sixth, potential publication bias cannot be excluded. Studies reporting negative or neutral findings, or those conducted in underrepresented populations or resource-limited settings, may be less likely to be published. This may result in overrepresentation of studies identifying barriers, potentially influencing the perceived consistency and strength of the findings.
+
+Seventh, although methodological quality appraisal indicated an overall moderate risk of bias, variations in study quality, sample size, and methodological rigor across included studies may influence confidence in the findings. Some studies lacked detailed reporting on recruitment strategies, reflexivity, or data saturation, which may affect interpretive transparency.
+
+Finally, most included studies were conducted in middle- to high-income healthcare settings, which may limit applicability to low-resource environments where structural barriers, workforce limitations, and access to interpreter services may differ substantially. Therefore, caution is warranted when generalizing these findings across diverse healthcare systems.
+
+Collectively, these limitations may influence the strength, precision, and generalizability of the conclusions. While the consistency of themes across diverse contexts supports the robustness of the findings, they should be interpreted with appropriate caution, particularly when informing clinical practice, policy development, or implementation strategies.
+
+Risk of Bias and Confidence in Findings
+
+Although methodological variability and potential sources of bias were identified, the overall risk of bias across included studies was considered moderate and acceptable relative to the aims of this review. Potential biases include heterogeneity in outcome definitions, reliance on self-reported data, and language restriction. However, the consistency of findings across diverse study designs, populations, and healthcare contexts strengthens confidence in the robustness of the identified themes, supporting moderate-to-high confidence in the overall conclusions.
+
+Equity and Relevance to Low-Resource Settings
+
+The barriers identified in this review may be even more pronounced in low-resource and underserved healthcare settings, where access to interpreter services, transcultural training, and institutional equity frameworks may be limited. Structural constraints, workforce shortages, and limited healthcare infrastructure may exacerbate communication barriers and inequities in care delivery. Addressing these challenges requires scalable, context-sensitive strategies, including community-based communication support, culturally responsive care models, and policy frameworks promoting inclusive and equitable healthcare access. Strengthening equity-oriented healthcare delivery is essential to improving outcomes among migrant and other vulnerable populations globally.
+
+Conclusions
+
+This systematic review demonstrates that immigrant patients face multiple, interconnected barriers when accessing healthcare services. Limited transcultural competence among healthcare professionals, persistent language barriers, and experiences of discrimination were consistently identified as key factors negatively affecting healthcare interactions, patient safety, satisfaction, and clinical outcomes, while also contributing to increased workload and professional strain among healthcare staff.
+
+The consistency of findings across diverse healthcare systems indicates that these challenges are systemic. From a clinical perspective, improving culturally responsive care requires integrating structured transcultural competence training into medical and nursing education, ensuring reliable access to professional interpreter services, and implementing institutional measures to reduce discriminatory practices in healthcare delivery. Strengthening communication and cultural understanding is essential for improving patient safety, trust, and quality of care in increasingly diverse populations.
+
+Future research should evaluate the clinical impact and effectiveness of targeted interventions, particularly transcultural competence training, interpreter services, and anti-discrimination strategies, on patient outcomes, healthcare quality, and equity. Addressing these barriers is fundamental to delivering safe, effective, and patient-centered care for immigrant populations.
+
+Disclosures
+
+Author Contributions
+
+Appendices
+
+Full Electronic Search Strategy - PubMed/MedLINE
+
+(Immigrants OR "Immigrant populations" OR "Migrant" OR "Migrants" OR "Refugees" OR "Asylum seekers" OR "Foreign-born" OR "Ethnic minorities") AND ("Health services accessibility"[MeSH] OR "Healthcare access" OR "Health care utilization" OR "Access to care" OR "Barriers to healthcare" OR "Healthcare disparities") AND ("Communication barriers" OR "Language barriers" OR "Interpreter services" OR "Health communication") AND ("Cultural competence" OR "Transcultural care" OR "Cross-cultural care" OR "Culturally competent care") AND ("Discrimination" OR "Healthcare discrimination" OR "Inequality" OR "Health inequities")
+
+Limits applied:
+
+Humans
+
+English language
+
+Publication date: January 2005 - August 2023
+
+The final search was executed on 31 August 2023.
+
+Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following:
+
+Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work.
+
+Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work.
+
+Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
+
+Concept and design:  Jasmin Alić, Ferid Krupić
+
+Acquisition, analysis, or interpretation of data:  Jasmin Alić, Ferid Krupić, Melissa Krupić, Emina Dervišević, Saidarab Sahra, Nail Seffo
+
+Drafting of the manuscript:  Jasmin Alić, Ferid Krupić, Melissa Krupić, Emina Dervišević, Saidarab Sahra, Nail Seffo
+
+Critical review of the manuscript for important intellectual content:  Jasmin Alić, Ferid Krupić, Melissa Krupić
+
+Supervision:  Ferid Krupić
+
+
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+46 Undocumented immigrants' and immigrant women's access to healthcare services in the Basque Country (Spain) Glob Health Action Pérez-Urdiales I 1896659 14 2021 33975531 10.1080/16549716.2021.1896659 PMC8118419
+47 Hospitalization experience of Muslim migrants in hospitals in southern Spain-Communication, relationship with nurses and culture. A focused ethnography Int J Environ Res Public Health Plaza Del Pino FJ Cala VC Soriano Ayala E Dalouh R 2791 17 2020 32316654 10.3390/ijerph17082791 PMC7215724
+48 Cultural competence in the community health context: 'we don't have to reinvent the wheel' Aust J Prim Health Truong M Gibbs L Paradies Y Priest N Tadic M 342 347 23 2017 28701258 10.1071/PY16073
+49 Patient safety culture and the cultural nursing care Rev Enferm UFPE Online Campelo CL Sousa SMA Silva LDC Dias RS Azevedo PR Nunes FDO Paiva SS 2500 2506 12 2018 https://periodicos.ufpe.br/revistas/revistaenfermagem/article/view/235048
+50 Contact with health-care service expectation and reality of situation experienced by immigrants seeking Swedish health-care Mater Sociomed Krupic F Sadic S Fatahi N 141 145 28 2016 https://pmc.ncbi.nlm.nih.gov/articles/PMC4851493/ 27147923 10.5455/msm.2016.28.141-145 PMC4851493
+51 Factors beyond the language barrier in providing health care to immigrant patients Med Arch Fatahi N Krupic F 61 65 70 2016 https://pmc.ncbi.nlm.nih.gov/articles/PMC4779347/ 26980935 10.5455/medarh.2016.70.61-65 PMC4779347
+52 Being immigrant in their own country: Experiences of Bosnians immigrants in contact with health care system in Bosnia and Herzegovina Mater Sociomed Krupic F Krupic R Jasarevic M Sadic S Fatahi N 4 9 27 2015 https://pmc.ncbi.nlm.nih.gov/articles/PMC4412908/ 25945077 10.5455/msm.2014.27.4-9 PMC4412908
+53 Racism in European health care: Structural violence and beyond Qual Health Res Hamed S Thapar-Björkert S Bradby H Ahlberg BM 1662 1673 30 2020 32546076 10.1177/1049732320931430 PMC7410275
+54 Increased perinatal mortality among sub-Saharan immigrants in a city-population in Sweden Acta Obstet Gynecol Scand Essén B Hanson BS Ostergren PO Lindquist PG Gudmundsson S 737 743 79 2000 https://pubmed.ncbi.nlm.nih.gov/10993096/ 10993096
+55 Hälsobegreppet - synen på hälsa och sjuklighet (Article in Swedish) Omvårdnadens grunder, 2nd ed Hedelin B Jormfeldt H Svedberg P 185 Lund Studentlitteratur 36 2014
+56 Swedish Parliament: Discrimination Act (SFS2008567) Swedish Parliament: Discrimination Act (SFS 12 2025 https://www.do.se/choose-language/english/discrimination-act-2008567
diff --git a/corpus/healthcare/text/ab8480e9bcdfec1d.txt b/corpus/healthcare/text/ab8480e9bcdfec1d.txt
new file mode 100644
index 0000000000000000000000000000000000000000..127fc6d64a842abdb9592d2ff74c7db0aa8fbe1f
--- /dev/null
+++ b/corpus/healthcare/text/ab8480e9bcdfec1d.txt
@@ -0,0 +1,65 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Oncol
+Journal ID: Front Oncol
+NLM Journal ID: 101568867
+Journal ID: Front. Oncol.
+
+Frontiers in Oncology
+
+EISSN: 2234-943X
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13532533
+PMID: 42683447
+DOI: 10.3389/fonc.2026.1959912
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Effect of bladder volume on dose of exposure to dangerous organs and incidence of cystitis and enteritis in patients with cervical cancer after external radiotherapy
+
+Wu Yanjiao 1 Formal analysis Writing – original draft Project administration Data curation Resources Visualization Methodology Validation Conceptualization Investigation Supervision Funding acquisition Writing – review & editing Software
+Xue Xiaoying 1 Writing – review & editing
+Su Linlin 1 Writing – review & editing
+Liu Yibin 2 * Writing – review & editing
+1 Department of Radiotherapy, The Second Hospital of Hebei Medical University , Shijiazhuang , Hebei ,  China
+2 Department of Gynecology, The Second Hospital of Hebei Medical University , Shijiazhuang , Hebei ,  China
+* Correspondence: Yibin Liu, 18831119883@163.com
+Electronic publication date: 2026 Aug 18
+Publication date: 2026
+Volume: 16
+Electronic Location ID: 1959912
+Received 2026 Aug 7; Accepted 2026 Aug 7
+Copyright: Copyright © 2026 Wu, Xue, Su and Liu.
+Copyright year: 2026
+Copyright holder: Wu, Xue, Su and Liu
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Effect of bladder volume on dose of exposure to dangerous organs and incidence of cystitis and enteritis in patients with cervical cancer after external radiotherapy 16 20 3 2026 1760076 Frontiers in Oncology 10.3389/fonc.2026.1760076 PMC13047064 41939472
+Keywords: bladder volume, cervical cancer, external pelvic irradiation, organ at risk, real-world data
+
+Funding: Health Commission of Hebei Province 10.13039/100017959
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 1
+
+section-at-acceptance: Gynecological Oncology
+
+Ÿ==============================Ÿ
+The funder “Medical Science Research Project of Hebei, 20241168” to “Yanjiao Wu” was erroneously omitted.
+
+The original version of this article has been updated.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
diff --git a/corpus/healthcare/text/b43c82fb6e5b1f49.txt b/corpus/healthcare/text/b43c82fb6e5b1f49.txt
new file mode 100644
index 0000000000000000000000000000000000000000..c27b97dae9e65d8cc879facdeeaf35b567ba5ece
--- /dev/null
+++ b/corpus/healthcare/text/b43c82fb6e5b1f49.txt
@@ -0,0 +1,765 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Clin Exp Dent Res
+Journal ID: Clin Exp Dent Res
+NLM Journal ID: 101692332
+Journal ID: CRE2
+
+Clinical and Experimental Dental Research
+
+EISSN: 2057-4347
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12415706
+PMID: 40919659
+DOI: 10.1002/cre2.70219
+Article ID: CRE270219
+Article version: 1
+Subjects: Review Article, Review Article
+
+Nanostructured Clays Used as Carriers for Controlled Delivery of Antibacterial Compounds From Direct Restorative Dental Materials: A Scoping Review
+
+de Barbosa Bárbara Faria Sa 1
+Ferreira Neto José Leôncio 1
+de Oliveira Francisca Jennifer Duarte 1
+Leitão Juliana Sales Osterno 2
+Costa Moan Jéfter Fernandes 3
+Sette‐de‐Souza Pedro Henrique https://orcid.org/0000-0001-9119-8435 3
+Fechine Pierre Basílio Almeida 2
+Feitosa Victor Pinheiro https://orcid.org/0000-0001-8795-9967 4 victor-feitosa@uiowa.edu
+
+Borges Boniek Castillo Dutra https://orcid.org/0000-0003-4313-5776 1
+1 Department of Dentistry Universidade Federal do Rio Grande do Norte (UFRN) Natal Rio Grande do Norte Brazil
+2 Group of Chemistry of Advanced Materials (GQMat), Department of Analytical Chemistry and Physical Chemistry Universidade Federal do Ceará (UFC) Fortaleza Ceará Brazil
+3 College of Dentistry Universidade de Pernambuco (UPE) Arcoverde Pernambuco Brazil
+4 Department of Operative Dentistry, College of Dentistry University of Iowa Iowa City Iowa USA
+* Correspondence: Victor Pinheiro Feitosa (victor-feitosa@uiowa.edu)
+
+Electronic publication date: 2025 Sep 8
+Publication date: 2025 Oct
+Volume: 11
+Issue: 5
+Electronic Location ID: e70219
+Revised 2025 Aug 11; Received 2025 Mar 10; Accepted 2025 Aug 28
+Copyright: © 2025 The Author(s). Clinical and Experimental Dental Research published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: dental materials, dentistry, montmorillonite, nanoparticle drug delivery system
+
+Funding: The authors received no specific funding for this work.
+Figure count: 3
+Table count: 4
+Page count: 17
+
+source-schema-version-number: 2.0
+cover-date: October 2025
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.6.2 mode:remove_FC converted:08.09.2025
+
+Barbosa, B. F. S , J. L. FerreiraNeto , F. J. D. Oliveira , et al. 2025. “Nanostructured Clays Used as Carriers for Controlled Delivery of Antibacterial Compounds From Direct Restorative Dental Materials: A Scoping Review.” Clinical and Experimental Dental Research 11: 1–17. 10.1002/cre2.70219.
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Objective
+
+Through a scoping review, this study meticulously mapped and characterized these nanostructured clays used to release antibacterial active compounds from direct restorative dental materials.
+
+Material and Methods
+
+The systematic approach involved searches in the PubMed/MEDLINE, Lilacs, Web of Science, Scopus, ScienceDirect, and Embase databases. Two independent and calibrated researchers (kappa: 0.94) performed all systematic steps according to the PRISMA guideline and the Joanna Briggs Institute Scoping Review Methodology Group (JBI) protocol. The reviewers developed a data extraction table to gather key information.
+
+Results
+
+A total of 782 articles were retrieved in the initial search using the specified strategies. After thoroughly reviewing the manuscripts, five were selected following the exclusion of duplicates and application of eligibility criteria. Montmorillonite and halloysite nanotubes emerged as the predominant nanostructured clay. Cetylpyridinium chloride was the most common active agent, notable for its antibacterial properties. Resin‐based composites were the most frequently studied direct restorative material for the prevention of recurrent caries.
+
+Conclusion
+
+Although the number of primary studies published in the literature was limited, montmorillonite and halloysite nanotubes appear to be promising nanocarriers for antibacterial active compounds in direct restorative dental materials.
+
+1 Introduction
+
+In recent years, there has been a growing interest in developing innovative strategies to solve some limitations of direct restorative dental materials. Recurrent caries lesions are the main cause of restorations' failure, which leads to the need for restorations' replacement, causing loss of dental tissues during cavity preparation and public expenditure on public health services (Askar et al. 2017; Elmergawy et al. 2021). Factors such as the patient's caries risk profile, dietary habits, and oral hygiene practices are crucial determinants that influence susceptibility to caries development (Pitts et al. 2017). The complex interplay of intrinsic and extrinsic factors underscores the need for proactive approaches, such as incorporating antibacterial‐carrying capabilities into direct restorative dental materials, especially through a nanocarrier, to effectively mitigate the risk of caries around restorations and promote long‐term dental health (Khatoon et al. 2020).
+
+Nanocarriers can allow the incorporation of functional compounds into dental materials, providing them with functional abilities (Costa et al. 2022). Controlled functional compound delivery systems have immense potential in dentistry, allowing the modulation of compounds' release kinetics to optimize therapeutic effects while minimizing adverse reactions (Villalba‐Rodríguez et al. 2021). Nanostructured clays, in particular, have garnered significant attention as potential carriers for the controlled delivery of functional compounds within dental materials, once they have good biocompatibility, high specific surface area, and interactions such as electrostatic and hydrogen bonds with the compound (Khatoon et al. 2020).
+
+Montmorillonite (MMT), halloysite nanotubes (HNTs), and Laponite RD are some of the most common nanostructured clays, each with unique properties that make them suitable for a variety of applications (Gaharwar et al. 2019). MMT, a smectite clay mineral with a 2:1 structural arrangement, is commonly used in dental composites and adhesives (Ritto et al. 2022; Tsolianos et al. 2023). HNTs, with their hollow tubular structure, have been explored for gene and drug delivery, as well as for use in tissue engineering (Naumenko and Fakhrullin 2019; de Abreu Pereira et al. 2021, 2023). Laponite RD, a synthetic trioctahedral smectite, is particularly notable for its dual charge distribution, which makes it highly effective in enhancing the exfoliation and dispersion of nanoparticles within polymer matrices (Gaharwar et al. 2019).
+
+Thus, nanostructured clays can offer the prospect of enhanced therapeutic outcomes and prolonged functional efficacy (Villalba‐Rodríguez et al. 2021). Once nanostructured clays can interact with different mineral and organic components, new opportunities arise for the design of functional direct restorative dental materials, such as resin‐based materials. Nanostructured clays can be designed to release therapeutic agents, such as antibacterial substances or drugs, in a controlled and sustained manner directly to the site of action (Villalba‐Rodríguez et al. 2021).
+
+There are primary studies evaluating the ability of resin‐based materials to release drugs and functional substances, such as cetylpyridinium chloride and chlorhexidine, which were incorporated through nanostructured clays (Boaro et al. 2019; Matsuo et al. 2019; Barot et al. 2020; Yamamoto et al. 2022; Otsubo et al. 2023; Timbó et al. 2024). Despite the growing interest in drug delivery systems for dental applications using nanostructured clays, there is still no synthesis of evidence, such as a scoping review, that compiles the nanostructured clays used, proper concentrations, form of incorporation, and efficacy of the controlled release of functional compounds within direct restorative dental materials. The knowledge about the main nanostructured clays used and characterizing the process would help researchers plan further investigations.
+
+The aim of this scoping review was to meticulously map and characterize the nanostructured clays used to carry functional compounds for controlled release in direct restorative dental materials, identifying key trends, gaps, and opportunities for further investigations.
+
+2 Methods
+
+2.1 Protocol and Registration
+
+In this scoping review, the authors followed the Joanna Briggs Institute (JBI) protocol and reported according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses extension for Scoping Reviews (PRISMA‐ScR) (Tricco et al. 2018).
+
+The protocol was registered on the Open Science Framework platform under the DOI 10.17605/OSF.IO/9846M. With the research question “What are the nanostructured clays, and how are they used as carriers for controlled drug delivery in direct restorative dental materials?”, a search strategy was developed based on the Population, Concept, Context (PCC) strategy recommended for scoping reviews: Population – nanostructured clays; Concept – nanostructured clays used as carriers for controlled functional compounds delivery; and Context – direct restorative dental materials.
+
+2.2 Eligibility Criteria
+
+This study included primary studies using nanostructured clays as a carrier to control the release of functional compounds in direct restorative dental materials without publication date or language restrictions. Studies with absent data regarding the conjugation and incorporation processes were excluded.
+
+2.3 Information Source
+
+The search strategy was meticulously designed to include both published and unpublished studies. An initial, limited search of PubMed was conducted to identify relevant articles. The text words contained in the titles and abstracts of relevant articles and the indexing terms used to describe the articles were utilized to develop a comprehensive search strategy for the electronic databases. The database search was conducted without language or publication year restrictions until October 2024. Two previously trained authors (B.F.S.B. and J.L.F.N.) searched the following electronic databases: PubMed/MEDLINE, Lilacs, Web of Science, Scopus, ScienceDirect, and Embase, published until October 2024. The search strategy was adapted to meet the specific requirements of each database (Table 1).
+
+Table 1 Specific search strategies for each database.
+
+Database	Search Strategy	Results	
+PubMed	(“montmorillonite KSF”[Supplementary Concept] OR “Bentonite”[MeSH Terms] OR “Bentonite” OR “montmorillonite” OR “montmorillonites” OR “montmorillonitic” OR “Iaponite” OR “laponite based nano materials” OR “laponite clay” OR “laponite nanostructured clay” OR “Nanostructured clay”) AND (“Nanoparticle Drug Delivery System”[MeSH Terms] OR “Nanoparticle Drug Delivery System” OR “Nanotechnology” OR “Nanotechnology”[MeSH Terms] OR “Chemical Actions and Uses”[MeSH Terms] OR “Chemical Actions and Uses”) AND (“Dental Materials”[MeSH Terms] OR “Dental Materials” OR “Biomedical and Dental Materials”[MeSH Terms] OR “Biomedical and Dental Materials” OR “Dentistry”[MeSH Terms] OR “Dentistry” OR “Resin Composite” OR “Glass Ionomer” OR “Adhesive System” OR “Adhesive Systems” OR “Glass Ionomer Cements”[MeSH Terms] OR “Glass Ionomer Cements” OR “Dentin‐Bonding Agents”[MeSH Terms] OR “Dentin‐Bonding Agents” OR “Self‐Curing of Dental Resins”[MeSH Terms] OR “Self‐Curing of Dental Resins” OR “Light‐Curing of Dental Adhesives”[MeSH Terms] OR “Light‐Curing of Dental Adhesives”)	516	
+Emtree/Embase	(‘montmorillonite’/exp OR ‘bentonite’/exp OR ‘laponite’/exp OR ‘nanostructured clay’/exp) AND (‘nanocarrier’/exp OR ‘nanotechnology’/exp OR ‘drug activity’/exp) AND (‘dental material’/exp OR ‘dentistry’/exp OR ‘odontology’/exp OR ‘resin’/exp OR ‘glass ionomer’/exp OR ‘dentin bonding agent’/exp OR ‘dental self‐curing’/exp OR ‘adhesive agent’/exp)	49	
+BVS/LILACS	(“montmorillonite”) OR (mh:(“montmorillonite”)) OR (“bentonite”) OR (mh:(“bentonite”)) OR (“laponite”) OR (“nanostructured clay”) AND (mh:(“nanoparticle based drug delivery system”)) OR (“nanoparticle based drug delivery system”) OR (mh:(“nanotechnology”)) OR (“nanoparticle”) AND (“dental”) OR (mh:(“materials, dental”)) OR (“resin dental”) OR (mh:(“resin, dental”)) OR (“resin composite”) OR (mh:(“resins, composite”)) OR (“dentistry”) OR (mh:(“dentistry”)) OR (“odontology”) OR (“glass ionomer cements”) OR (mh:(“glass ionomer cements”)) OR (“dentin bonding agents”) OR (mh:(“dentin bonding agents”)) OR (“self‐cured dental bonding”) OR (mh:(“self‐curing of dental resins”)) OR (“self‐curing of dental resins”) OR (“light‐curing of dental adhesives”) OR (mh:(“light‐curing of dental adhesives”))	127	
+ScienceDirect	(“montmorillonite clay” OR nanostructured clay) AND (“nanoparticle based drug delivery system” OR nanocarrier OR nanotechnology) AND (dentistry OR “dental material”)	153	
+Scopus	(KEY (montmorillonite) OR KEY (bentonite) OR KEY (saponite) OR TITLE‐ABS‐KEY (montmorillonite) OR TITLE‐ABS‐KEY (organoclay) AND TITLE‐ABS‐KEY (Nanoparticle Drug Delivery System) OR KEY (Nanotechnology) OR KEY (Chemical Actions and Uses) AND KEY (Dental Materials) OR TITLE‐ABS‐KEY (Dentistry) OR TITLE‐ABS‐KEY (Resin Composite) OR TITLE‐ABS‐KEY (Glass Ionomer) OR TITLE‐ABS‐KEY (Adhesive Systems) OR TITLE‐ABS‐KEY (Dentin‐Bonding Agents) OR TITLE‐ABS‐KEY (Self‐Curing of Dental Resins) OR KEY (Light‐Curing of Dental Adhesives))	49	
+Web of Science	“Montmorillonite” OR “Bentonite” OR “Laponite” OR “Nanostructured clay” AND “Nanoparticle Drug Delivery System” OR “Nanoparticle” OR “Nanotechnology” OR “Chemical Actions and Uses” AND “Dental Materials” OR “Biomedical and Dental Materials” OR “Dentistry” OR “Resin Composite” OR “Glass Ionomer” OR “Glass Ionomer Cements” OR “Adhesive System” OR “Dentin‐Bonding Agents” OR “Self‐Curing of Dental Resins” OR “Light‐Curing of Dental Adhesives” OR “Odontology”	9	
+John Wiley & Sons, Ltd.
+
+2.4 Search Strategy
+
+The systematic searches (Table 1) were conducted based on Medical Subject Headings (MeSH) or the following specific text words: “montmorillonite”; “bentonite”; “iaponite”; “laponite based nano materials”; “laponite clay”; “laponite nanostructured clay”; “nanostructured clay”; “nanocarrier”; “nanoparticle drug delivery system”; “nanoparticle based drug delivery system”; “nanotechnology”; “chemical actions and uses”; “drug activity”; “dental materials”; “biomedical and dental materials”; “dentistry”; “resin”; “resin composite”; “glass ionomer”; “adhesive system”; “adhesive agent”; “glass ionomer cements”; “dentin‐bonding agents”; “self‐curing of dental resins”; “light‐curing of dental adhesives”.
+
+The exhaustive search strategy across numerous databases aimed to gather a broad array of pertinent publications, minimizing the risk of overlooking crucial studies. Leveraging MeSH terms and precise keywords optimized the search process to retrieve studies concerning nanostructured clays used as carriers for controlled drug delivery and related subjects.
+
+2.5 Selection of Evidence Sources
+
+For the organization and selection of studies, the Rayyan software (QCRI, Qatar Computing Research Institute; https://rayyan.qcri.org/) was employed to facilitate the screening and synthesis of articles. After removing duplicates, two authors (B.F.S.B. and J.L.F.N.), previously calibrated (K = 0.94), independently evaluated the titles and abstracts to exclude ineligible studies. Following a complete reading of the studies, articles that did not address the topics of the acronym, either in terms of functional compounds' release or description of the nanostructured clay used in the investigated material, were excluded, resulting in the removal of 6 articles. A flowchart was developed for the final selection of the studies to map and present the data found (Figure 1).
+
+Figure 1 Flowchart with the entire process of identifying studies and databases.
+
+2.6 Data Charting Process
+
+Following the final selection of articles, the reviewers (B.F.S.B. and J.L.F.N.) created a data extraction tool to gather information from each included source of evidence. They independently organized, discussed, and continually refined the data‐charting process. Any disagreements were resolved through discussion or involving a third reviewer (F.J.D.O).
+
+Both reviewers independently extracted data using a standardized form in Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA). The form captured key information relevant to the scoping review's questions. Any discrepancies were resolved through discussions between the two reviewers or, if necessary, by consulting a third reviewer for further clarification.
+
+2.7 Data Extraction Process
+
+Data were extracted from studies that met the inclusion criteria for analysis. The two reviewers developed a data extraction table to determine the key information. The data extracted from each article included: Authorship, date, and location of publication, title, study type, nanostructured clay used, concentration and weight of nanostructured clay, the functional compound used for release and its concentration, direct restorative dental material used in the study, method of functional compound incorporation, nanostructured clay surface modification, methods of agglutination, main results, and authors' conclusions.
+
+The summary facilitated synthesizing the extracted data, allowing both reviewers and readers to understand the overall information and implications of the included studies.
+
+2.8 Risk of Bias Assessment
+
+The risk of bias assessment was performed using the Quality Assessment of in vitro studies (QUIN tool), which comprehends twelve domains: aims/objectives, sample calculation, sampling technique, details of groups, methodology explanation, operator details, randomization, method of outcome measurement, outcome assessor details, blinding, statistical analysis, and presentation of the results. Each domain was scored as “not specified” (score = 0), “inadequately specified” (score = 1), or “adequately specified” (score = 2). The RoB (%) was estimated using the following equation: RoB(%)=(totalscore×100)/(two×numberofapplicablecriteria)
+
+Studies were graded according to their obtained RoB as high risk (< 50%), medium risk (> 50% < 70%), or low risk (> 70%).
+
+The primary studies included in the sample were analyzed independently by the two reviewers. Conflicts were solved by discussion with a third reviewer.
+
+3 Results
+
+3.1 Selection of Sources of Evidence
+
+The database searches identified 903 studies. After removing duplicates, 821 studies remained (Figure 1). During the screening process, 810 reports were excluded based on their titles and abstracts. Subsequently, 11 potentially eligible studies were selected for further assessment, and their full texts were obtained in PDF format. After thoroughly evaluating these studies, 6 were excluded based on the eligibility criteria (Figure 1). Thus, five studies were eligible for inclusion in this scoping review synthesis.
+
+3.2 Characteristics of Evidence Sources
+
+The studies included in this scoping review were published in 2019 (n = 2), 2020 (n = 1), 2022 (n = 1), and 2023 (n = 1). The countries investigating this topic included Brazil (n = 1), India (n = 1), and Japan/Belgium (n = 3). Regarding the nature of the evidence, in vitro studies (n = 5) assessed experiments testing the development of new direct restorative dental materials. The investigated types of materials were resin composite (n = 3), adhesive system (n = 1), and dental cement (n = 1).
+
+The studies aimed to develop a functional compound delivery system within the tested materials. The researchers focused on nanostructured clays capable of entrapping antimicrobial agents and gradually releasing them in an aqueous media, aiming to prevent the onset of caries adjacent to the restorative material. Consequently, the nanostructured clays used in these studies were MMT (n = 4) (Figure 2) and HNTs (n = 1) (Figure 3).
+
+Figure 2 Schematic representation of the molecular structure of montmorillonite (MMT).
+
+Figure 3 Schematic illustration of the molecular structure of halloysite nanotubes (HNTs).
+
+Similarly, the studies retrieved in this review addressed three antimicrobial agents: farnesol (FA) (n = 1), chlorhexidine (CHX) (n = 1), and cetylpyridinium chloride (CPC) (n = 3). Given the variety of agents used, there was no consensus regarding the optimal concentration of these products to be released in an aqueous media.
+
+Another way to improve the adhesion of the antimicrobial agent to the delivery vehicle is through the surface treatment of nanostructured clays. Various techniques have been employed to alter the structure of these nanomaterials to enhance their properties and efficacy as drug‐delivery vehicles. These modifications can be achieved through chemical processes, involving alterations in chemical composition and ion replacement (de Abreu Pereira et al. 2021). However, none of the articles included in this review reported surface treatments to improve the adhesion between antimicrobial agents and nanostructured clays.
+
+3.3 Results of Individual Sources of Evidence
+
+Barot et al. (2020) observed that incorporating the farnesol with halloysite nanotubes (Fa‐HNT system), with weight variations from 1 to 7 wt%, enhanced the mechanical properties of the dental resin composites. The addition of Fa‐HNT enhanced the mechanical properties of the resin compared to the control group. The mean flexural strength and compressive strength values were highest at a 7 wt% concentration, which was considered the optimal concentration. Scanning Electron Microscopy (SEM) images showed a uniform distribution of the nanostructured clay system and functional compound throughout the dental composite. The dental composite exhibited strong antimicrobial activity against S. mutans, with inhibition zones ranging from 6 to 13 mm. No cytotoxicity over 24, 48, and 72 h was observed, maintaining cell viability above 92%, which indicates its safety for use.
+
+Matsuo et al. (2019) found that the release of CPC from 3 wt% adhesive formulations was superior to the 1 wt% formulation, noting the controlled release of the cetylpyridinium chloride with montmorillonite (CPC‐MMT system) over 10 days. Inhibition against S. mutans was observed for the 1 wt% and 3 wt% adhesive formulations. The 3 wt% formulation significantly reduced biofilm formation. Adequate cell viability was reported in cytotoxicity tests. With high magnification, using Field‐emission‐gun Scanning Electron Microscope (Feg‐SEM), the authors observed CPC‐MMT particles within the adhesive layers at the interfaces.
+
+Boaro et al. (2019) demonstrated that CHX released from composites containing 2.5 wt% was higher than 5 wt% and 10 wt% over a 28‐day follow‐up. Micrographs displayed CHX incorporation into MMT and linear distribution in the specimen. All groups showed inhibition zones against S. mutans, S. aureus, and P. gengivalis, but only the specimens with 5% and 10% CHX exhibited antimicrobial activity against P. gengivalis. The CHX groups had greater inhibition compared to those with MMT alone. No statistical difference in biofilm formation was noted for groups of the same concentration containing either MMT or chlorhexidine with montmorillonite (CHX‐MMT system).
+
+Otsubo et al. (2023) reported a gradually decreasing release of CPC from self‐curing dental resin specimens. The group with the highest sustained release of CPC was CPC‐MMT in Days 1–5, after which all groups exhibited similar release profiles. Tests showed that the CPC‐MMT group was able to reabsorb CPC and release it in a sustained manner, with a peak on the seventh day. Samples containing CPC‐MMT displayed greater turbidity, indicating antimicrobial efficacy. The mechanical strength decreased with the addition of MMT (CPC‐MMT group), reducing flexural strength by 36% compared to the control. The CPC‐MMT group also showed pigmentation compared to the control, with noticeable color changes in all evaluations.
+
+Yamamoto et al. (2022) using a dual‐cure composite cement, observed that there were no significant changes in mechanical properties when adding a 2 wt% CPC‐MMT system. CPC release was observed over 7 days, being highest on the first day, but continuing at a decreased concentration thereafter. Regarding biofilm formation, it was noted that no biofilm formed at all concentrations of CPC‐MMT.
+
+3.4 Synthesis of Results
+
+Overall, nanostructured clays have proven effective as a carrier for controlled delivery of functional compounds in direct restorative dental materials. All studies observed good bacterial inhibition and biofilm reduction levels despite the different concentrations of functional compounds and nanostructured clays. A common concentration range of 3% to 10% of active agent incorporated into the nanoclay was observed across all studies, with concentrations between 5% and 7.5% consistently yielding the most favorable outcomes in all evaluated tests. All formulations in the selected studies demonstrated controlled release of the functional compounds and maintained their important physical and chemical properties for direct restorative dental materials. The controlled release was observed over several days and began reducing its effect after a maximum of 28 days. The data extraction of primary studies included in this scoping review can be found in Tables 2 and 3.
+
+Table 2 General data extraction from primary studies.
+
+References	Nanostructured clay	Carried compound	Nanostructured clay surface modification	Method of agglutination	Final preparation concentrations	Dental material	Tested groups	Methods of characterization	Main results	
+Barot et al. (2020)	HNT	FA	Not reported	Solubilization ‐ ethanol solution	0,02 g/mL (total filler load maintained at 50 wt%).	Resin composites ‐ 50 wt % of dimethacrylate‐based resin matrix (Bis‐GMA/TEGDMA ‐ 50/50 wt/wt. Respectively, with 0.5 wt % CQ and 0.5 wt% EDMAB as a photoinitiator system).	Control group and seven groups containing different mass fractions of Fa‐HNT (1, 3, 7, 10, 13, 17 and 20 wt%).	Identification of the nanostructured clay with the functional compound through surface morphology (SEM);
+
+Internal structure visualization (TEM);
+
+Chemical bond vibrations (FT‐IR);
+
+The crystalline structure of the system (XRD);
+
+Flexural Strength (UTM);
+
+Flexural Modulus (UTM);
+
+Compressive Strength (UTM);
+
+Degree of conversion (FT‐IR);
+
+Curing depth (DC);
+
+Antimicrobial activity (DDA);
+
+Cytotoxicity (MTT).
+
+	SEM images revealed that most specimens are polydisperse cylindrical tubes, measuring between 100 and 200 nm in length;
+
+Specimens observed under TEM reveal a hollow, open‐ended tubular structure of nanotubes;
+
+After loading FA, the entrapment efficiency percentage in the internal lumen was determined to be 74%;
+
+The diffraction analysis indicates that loading Farnesol into HNTs does not alter the crystalline structures of the HNTs;
+
+The incorporation of HNT‐based fillers in dental composites significantly improved both flexural and compressive strengths, with optimal results observed at a 7 wt% concentration of FA‐HNT filler. However, increasing the filler content beyond this level (13–20 wt%) led to a decline in mechanical properties;
+
+As the concentration of FA‐HNT increased from 1 to 10 wt%, the DC values decreased, but this trend intensified at concentrations of 13–20 wt%;
+
+The sequential addition of FA‐HNT filler (1–20 wt%) in dental composites led to a gradual decrease in curing depth, likely due to the higher refractive index of HNTs;
+
+Antibacterial activity against S. mutans increased with FA‐HNT concentration, peaking at 20 wt%;
+
+Fa‐HNT composites also showed minimal cytotoxicity on NIH‐3T3 cells.
+
+	
+Boaro et al. (2019)	MMT	CHX	Not reported	Solubilization ‐ aqueous solution	1 mg/100 mL	Resin composite ‐ organic phase (Bis‐GMA/TEGDMA ‐ 50/50 wt/wt.) Photoinitiator system (DMAEMA 1%/camphorquinone 0.8% (w/w)).	Three experimental resin composites containing MMT particles at 2.5, 5% and 10% (w/w), and three experimental resin composites with CHX/MMT at 2.5, 5% and 10% (w/w).	Decomposition profile of MMT particles (TGA);
+
+The type of interaction between MMT particles and CHX (XRD);
+
+Surface morphology and the particle size distribution (SEM);
+
+Degree of conversion (FT‐IR);
+
+Flexural strength (UTM);
+
+Internal structure visualization (TEM);
+
+Evaluation of the release of CHX (UV spectrophotometry);
+
+Antibacterial activity (AM; BF).
+
+	Resin composite with improved thermal stability, but a mass loss around 7% higher;
+
+The XRD suggests the incorporation of CHX between the MMT layers.
+
+The particles presented the same pattern in both cases (with or without CHX);
+
+The degree of conversion ranged from 71% to 74%;
+
+The flexural modulus ranged from 5.7 to 8.1 GPa;
+
+The flexural strength ranged from 61.4to 74.7 MPa.
+
+The resin composite containing 2.5 wt% MMT/CHX presented higher chlorhexidine release than 5 and 10 wt%. The specimens released CLX during the 28 days.
+
+The resin composite showed potential as a dental material with local antibacterial activity against various oral bacteria, including S. mutans, P. gingivalis, and S. aureus, while also reducing biofilm formation.
+
+	
+Matsuo et al. (2019)	MMT	CPC	Not reported	Solubilization ‐ aqueous solution	1 g/100 mL	Adhesive ‐ The one‐step self‐etch adhesive was modified by adding 1 wt% and 3 wt% CPC‐MMT, 3 wt% MMT (without CPC) and 1 wt% and 3 wt% CPC (without MMT)	Five experimental groups: 1 wt% and 3 wt% CPC‐MMT, 3 wt% MMT (without CPC) and 1 wt% and 3 wt% CPC (without MMT)	The crystalline structure of the system (XRD);
+
+CPC release (UV‐vis);
+
+Biofilm formation (Feg‐SEM);
+
+Cytotoxicity (MTT);
+
+Degree of conversion (FT‐IR);
+
+Micro‐tensile dentin bond strength (μTBS);
+
+Adhesive‐dentin interfacial visualization (TEM);
+
+Rechargeability CPC (XRD).
+
+	XRD analysis confirmed CPC incorporation into MMT and detailed its release mechanism and the result indicating high crystallinity;
+
+Feg‐SEM revealed at relatively low magnification irregular globular particles of MMT varying in size;
+
+The 3 wt% CPC/MMT adhesive formulation released more CPC than 1 wt%, and occurred for 10 days. 3 wt% CPC reduced biofilm formation;
+
+Cell viability decreased for all experimental conditions compared to the control (no disk);
+
+Only the 3 wt% CPC adhesive formulation (without MMT) showed a significantly lower degree of conversion;
+
+All tested adhesive formulations showed no significant difference in immediate dentin μTBS;
+
+TEM analysis showed tight adhesive‐dentin interfaces for all formulations;
+
+Significant S. mutans growth was observed before recharge, but no growth occurred afterward.
+
+	
+Otsubo et al. (2023)	MMT	CPC	Not reported	Solubilization – aqueous solution	10 wt%	Self‐curing resin ‐ copolymer of methacrylic ester; methyl methacrylate; tertiary amine; pigment.	Three experimental groups: Resin‐MMT; Resin‐NPS; Resin‐CPC (control)	Antimicrobial agent sustained release capacity (HPLC);
+
+Reuptake capacity (LC);
+
+Antimicrobial efficacy (S);
+
+Mechanical Strength ‐ three‐point bending test (UTM);
+
+Color change (CR‐20).
+
+	The sustained release of CPC decreased gradually across all specimens, with Resin‐MMT showing higher release than resin‐NPS from days 1–5, but both became nearly equal after day 6;
+
+The amount of CPC sustained release decreased gradually in the same manner as before reuptake;
+
+Resin‐MMT and Resin‐NPS groups showed sustained CPC release and effective reuptake. They released CPC against Streptococcus mutans for 14 days and post‐reuptake;
+
+MMT reduced mechanical strength, with resin‐Mont showing a 36% decrease in flexural strength, compared to control;
+
+The color difference of all specimens on day 0, day 7, and day 7 after reuptake exceeded the just‐noticeable difference compared to the control.
+
+	
+Yamamoto et al. (2022)	MMT	CPC	Not reported	Solubilization ‐ aqueous solution	1 g/100 mL
+
+10.s5 g/250 mL
+
+	Resin cement ‐ The base paste was modified by adding either CPC‐MMT30 or CPC‐MMT7 (Different particle sizes CPC‐MMT with a median diameter of 30 μm and 7 μm) at concentrations of 2, 3, 4, 5 and 7.5 wt% in respect to the cement's total weight.	Ten experimental groups: CPC‐MMT30 or CPC‐MMT7 at concentrations of 2, 3, 4, 5 and 7.5 wt%	Flexural strength, elastic modulus and fracture toughness (UTM);
+
+Micro‐tensile bond to dentin (μTBS);
+
+CPC release (UV‐vis);
+
+Biofilm formation (SEM).
+
+	The 7.5 wt% CPC‐MMT30 had significantly lower mean flexural strength than the control. The elastic modulus varied between 3.8 to 4.9 GPa with no significant differences among cement formulations. However, fracture toughness notably decreased with the addition of CPC‐MMT30. In contrast, CPC‐MMT7 formulations showed no significant reductions in mechanical Properties;
+
+Bond strength decreased as CPC‐MMT30 concentration increased, with the 7.5 wt% CPC‐MMT30 formulation showing the lowest μTBS;
+
+Both the experimental CPC‐MMT30 and CPC‐MMT7 resin cement formulations presented a similar tendency in CPC‐release behavior;
+
+Adding 5‐7.5 wt% CPC‐MMT7 preserved properties and provided ongoing anti‐biofilm activity, with no biofilm formation observed on 5 wt% and 7.5 wt% CPC‐MMT7 disks after 30 days.
+
+	
+Abbreviations: MMT, montmorillonite; HNT, halloysite nanotubes; NPS, nanoporous silica; CPC, cetylpyridinium chloride; CHX, chlorhexidine; FA, farnesol; XDR, X‐ray diffractometer; SEM, scanning electron microscopy; FT‐IR, infrared spectrophotometer with Fourier Transform; TEM, transmission electron microscopy; UTM, Universal Testing Machine; DC, digital calliper; DDA, disk diffusion assay; AM, agardilution method; BF, biofilm Formation; TGA, thermogravimetry analysis; MTT, MTT ((3‐[4,5‐dimethylthiazol‐2‐yl]‐2,5 diphenyl tetrazolium bromide) assay/cytotoxicity test; μTBS, micro‐tensile testing device; UV–vis, UV–vis Spectroscopy; HPLC, high performance liquid chromatography; LC, liquid chromatography; S, spectrophotometer; CR‐20, portable colorimeter.
+
+John Wiley & Sons, Ltd.
+
+Table 3 Quantitative data regarding mechanical and antimicrobial tests extracted from primary studies according to the groups evaluated.
+
+References	Flexural strength (MPa) (Mean ± SD)	Elastic modulus (GPa) (Mean ± SD)	Flexural modulus (GPa) (Mean ± SD)	Microtensile bond strength (MPa) (Mean ± SD)	Compressive strength (MPa) (Mean ± SD)	Fracture toughness (MPa·m¹/²) (Mean ± SD)	Cytotoxicity (% viability) (Mean ± SD)	Antimicrobial efficacy	Degree of conversion (DC) (Mean ± SD)	
+Barot et al. (2020)	Control (104.2 ± 0.00) (a)
+
+Fa‐HNT 1% (RF) (b)
+
+Fa‐HNT 3% (RF) (b)
+
+Fa‐HNT 7% (115.9 ± 2.07) (c)
+
+Fa‐HNT 10% (RF) (d)
+
+Fa‐HNT 13% (RF) (d)
+
+Fa‐HNT 17% (RF) (d)
+
+Fa‐HNT 20% (RF) (d)
+
+Results: c > b > a > d
+
+	Not evaluated	Control (6.50 ± 0.00)
+
+Fa‐HNT 1% (RF)
+
+Fa‐HNT 3% (RF)
+
+Fa‐HNT 7% (RF)
+
+Fa‐HNT 10% (RF)
+
+Fa‐HNT 13% (RF)
+
+Fa‐HNT 17% (RF)
+
+Fa‐HNT 20% (RF)
+
+Results: no statistically significant differences among the groups
+
+	Not evaluated	Control (280.5 ± 0.00) (b)
+
+Fa‐HNT 1% (RF) (a)
+
+Fa‐HNT 3% (RF) (a)
+
+Fa‐HNT 7% (310. 60 ± 2.40) (a)
+
+Fa‐HNT 10% (RF) (c)
+
+Fa‐HNT 13% (RF) (c)
+
+Fa‐HNT 17% (RF) (c)
+
+Fa‐HNT 20% (RF) (c)
+
+Results: a > b > c
+
+	Not evaluated	Control (100)
+
+Fa‐HNT 1% (RF)
+
+Fa‐HNT 3% (RF)
+
+Fa‐HNT 7%
+
+24 h: (92,3);
+
+48 h: (97,8);
+
+72 h: (100)
+
+Fa‐HNT 10% (RF)
+
+Fa‐HNT 13% (RF)
+
+Fa‐HNT 17% (RF)
+
+Fa‐HNT 20% (RF)
+
+Results: no statistically significant differences among the groups
+
+	Not evaluated	Control (RF)
+
+Fa‐HNT 1% (RF)
+
+Fa‐HNT 3% (RF))
+
+Fa‐HNT 7% (RF)
+
+Fa‐HNT 10% (RF)
+
+Fa‐HNT 13% (RF)
+
+Fa‐HNT 17% (RF)
+
+Fa‐HNT 20% (RF)
+
+	
+Boaro et al. (2019)	Resin matrix (control) (66.4 ± 15.5)
+
+2.5% MMT (61.4 ± 15.0)
+
+2.5% MMT/CHX (71.0 ± 17.6)
+
+5% MMT (61.9 ± 17.8)
+
+5% MMT/CHX (62.1 ± 8.8)
+
+10% MMT (74.7 ± 17.4)
+
+10% MMT/CHX (69.9 ± 10.0)
+
+	Resin matrix (control) (8.1 ± 1.76)
+
+2.5% MMT (7.5 ± 1.55)
+
+2.5% MMT/CHX (7.1 ± 1.62)
+
+5.0% MMT (7.6 ± 2.04)
+
+5.0% MMT/CHX (6.4 ± 1.23)
+
+10.0% MMT (5.7 ± 1.28)
+
+10.0% MMT/CHX (6.9 ± 2.00)
+
+	Not evaluated	Not evaluated	Not evaluated	Not evaluated	Not evaluated	Not evaluated	(Measured after 10 min)
+
+Resin matrix (74 ± 7)
+
+2.5% MMT (71 ± 5)
+
+2.5% MMT/CHX (74 ± 8)
+
+5% MMT (73 ± 7)
+
+5% MMT/CHX (74 ± 3)
+
+10% MMT (71 ± 5)
+
+10% MMT/CHX (72 ± 6)
+
+	
+Matsuo et al. (2019)	Not evaluated	Not evaluated	Not evaluated	1% CPC_Mont (RF)
+
+3% CPC_Mont (RF)
+
+1% CPC (RF)
+
+3% CPC (RF)
+
+Only 3 wt% CPC had significantly reduced immediate and aged bond strength
+
+	Not evaluated	Not evaluated	Cytotoxicity (MTT assay)
+
+Mont (RF)
+
+C‐S3B (RF)
+
+1% CPC_Mont (RF)
+
+3% CPC_Mont (RF)
+
+1% CPC (RF)
+
+3% CPC (RF)
+
+3 wt% CPC significantly more cytotoxic than other groups
+
+	Not evaluated	Mont (RF)
+
+C‐S3B (RF)
+
+1% CPC_Mont (RF)
+
+3% CPC_Mont (RF)
+
+1% CPC (RF)
+
+3% CPC (RF)
+
+Only 3 wt% CPC had lower polymerization conversion than other adhesives
+
+	
+Otsubo et al. (2023)	Resin‐cont (85.8 ± RF)
+
+Resin‐NPS (64.0 ± RF)
+
+Resin‐Mont (54.9 ± RF)
+
+Resin‐CPC (59.2 ± RF)
+
+There is a statistically significant difference (p < 0.05) between the control group (resin‐cont) and all other groups
+
+	Not evaluated	Not evaluated	Not evaluated	Not evaluated	Not evaluated	Not evaluated	Control (RF)
+
+Resin‐Mont (RF)
+
+Resin‐NPS (RF)
+
+Resin‐CPC (RF)
+
+No statistical difference explicitly reported
+
+	Not evaluated	
+Yamamoto et al. (2022)	0 wt% Control CPC‐Mont30 (RF)
+
+2 wt% ‐ CPC‐Mont30 (RF)
+
+3 wt% ‐ CPC‐Mont30 (RF)
+
+4 wt% ‐ CPC‐Mont30 (RF)
+
+5 wt% ‐ CPC‐Mont30 (RF)
+
+7.5 wt% ‐ CPC‐Mont30 (45.6 ± 6.9)
+
+Lower statistically significant difference than control, 2%, 3% and 4% CPC‐Mont30
+
+CPC‐Mont7‐Controle: (RF)
+
+2 wt% ‐ CPC‐Mont7 (RF)
+
+3 wt% ‐ CPC‐Mont7 (RF)
+
+4 wt%‐ CPC‐Mont7 (RF)
+
+5 wt% ‐ CPC‐Mont7 (RF)
+
+7.5 wt% ‐ CPC‐Mont7 (RF)
+
+	0 wt% Control CPC‐Mont30 (RF)
+
+2 wt% ‐ CPC‐Mont30 (RF)
+
+3 wt% ‐ CPC‐Mont30 (RF)
+
+4 wt% ‐ CPC‐Mont30 (RF)
+
+5 wt% ‐ CPC‐Mont30 (RF)
+
+7.5 wt% ‐ CPC‐Mont30 (RF)
+
+CPC‐Mont7‐Controle: (RF)
+
+2 wt% ‐ CPC‐Mont7 (RF)
+
+3 wt% ‐ CPC‐Mont7 (RF)
+
+4 wt%‐ CPC‐Mont7 (RF)
+
+5 wt% ‐ CPC‐Mont7 (RF)
+
+7.5 wt% ‐ CPC‐Mont7 (RF)
+
+No statistically significant differences among groups
+
+	Not evaluated	0 wt% Control CPC‐Mont30 (RF)
+
+2 wt% ‐ CPC‐Mont30 (RF)
+
+3 wt% ‐ CPC‐Mont30 (RF)
+
+4 wt% ‐ CPC‐Mont30 (RF)
+
+5 wt% ‐ CPC‐Mont30 (RF)
+
+7.5 wt% ‐ CPC‐Mont30 (6.4 ± 3.2)
+
+CPC‐Mont7‐Controle: (RF)
+
+2 wt% ‐ CPC‐Mont7 (RF)
+
+3 wt% ‐ CPC‐Mont7 (RF)
+
+4 wt%‐ CPC‐Mont7 (RF)
+
+5 wt% ‐ CPC‐Mont7 (RF)
+
+7.5 wt% ‐ CPC‐Mont7 (RF)
+
+CPC‐Mont30 – 2 wt%, 7.5 wt% and CPC‐Mont30 ‐ 7,5 wt% showed significantly lower fracture toughness compared to the control
+
+	Not evaluated	Fracture toughness (MPa·m¹/²)
+
+0 wt% Control CPC‐Mont30 (RF)
+
+2 wt% ‐ CPC‐Mont30 (RF)
+
+3 wt% ‐ CPC‐Mont30 (RF)
+
+4 wt% ‐ CPC‐Mont30 (RF)
+
+5 wt% ‐ CPC‐Mont30 (RF)
+
+7.5 wt% ‐ CPC‐Mont30 (RF)
+
+CPC‐Mont7‐Controle: (RF)
+
+2 wt% ‐ CPC‐Mont7 (RF)
+
+3 wt% ‐ CPC‐Mont7 (RF)
+
+4 wt%‐ CPC‐Mont7 (RF)
+
+5 wt% ‐ CPC‐Mont7 (RF)
+
+7.5 wt% ‐ CPC‐Mont7 (RF)
+
+CPC‐Mont30 – 2 wt% and 7.5 wt% showed significantly lower fracture toughness compared to the control
+
+	Not evaluated	Not evaluated	Not evaluated	
+Abbreviations: MMT, montmorillonite; HNT, halloysite nanotubes; NPS, nanoporous silica; CPC, cetylpyridinium chloride; CHX, chlorhexidine; FA, farnesol; SD, standard deviation; Fa‐HNT, farnesol incorporated halloysite nanotubes; RF, the presentation in the figure did not allow for the exact numerical extraction of the data (mean ± SD); MMT, montmorillonite; MMT/CHX, chlorhexidine‐incorporated montmorillonite; CPC_Mont, cetylpyridinium chloride incorporated montmorillonite; CPC, cetylpyridinimmum chloride; Resin‐Mont, autopolymerizing resin containing montmorillonite (Mont) loaded with cetylpyridinium chloride (CPC); Resin‐NPS, autopolymerizing resin containing nanoporous silica (NPS) also loaded with CPC; Resin‐CPC, autopolymerizing resin with CPC directly added, without using a carrier such as Mont or NPS; CPC‐Mont30, cetylpyridinium chloride incorporated montmorillonite with an average diameter of 30 µm; CPC‐Mont7, cetylpyridinium chloride incorporated montmorillonite with an average diameter of 7 µm.
+
+John Wiley & Sons, Ltd.
+
+3.5 Risk of Bias Assessment
+
+In the risk of bias analysis, all the articles were classified as medium risk. The most penalized domains were C2, C6 and C7. In domain C2, all studies were classified with zero because the authors did not mention a sample size calculation. Domains C6 and C7 received zero ratings due to a lack of operator information and sample randomization (Table 4).
+
+Table 4 Risk of bias assessment of included studies.
+
+Study	C1	C2	C3	C4	C5	C6	C7	C8	C9	C10	C11	C12	FS	%RoB	RoB	
+Barot et al. (2020)	2	0	2	2	2	0	0	2	1	NA	1	2	14	63%	Medium risk	
+Boaro et al. (2019)	2	0	2	2	2	0	0	2	1	NA	2	2	15	68%	Medium risk	
+Matsuo et al. (2019)	2	0	2	2	2	0	0	2	1	NA	2	2	15	68%	Medium risk	
+Otsubo et al. (2023)	2	0	1	2	2	0	0	2	1	NA	0	2	12	54%	Medium risk	
+Yamamoto et al. (2022)	2	0	2	2	2	0	0	2	1	NA	2	2	15	68%	Medium risk	
+Note: QUIN Tool's criteria: C1, clearly stated aims/objectives; C2, detailed explanation of sample size calculation; C3, detailed explanation of sampling technique; C4, details of comparison group; C5, detailed explanation of methodology; C6, operator details; C7, randomization; C8, method of measurement of outcome; C9, outcome assessor details; C10, blinding; C11, statistical analysis; C12, presentation of results; N/A, not applicable; FS, final score; %RoB, percentage of risk of bias; RoB, risk of bias. %RoB < 50% high risk, 50% < %RoB < 70% medium risk, %RoB > 70% low risk.
+
+John Wiley & Sons, Ltd.
+
+4 Discussion
+
+This scoping review explored and characterized nanostructured clays used as carriers for the controlled delivery of functional compounds in direct restorative dental materials. Thus, the type of nanostructured clay chosen, the functional compound used and its function, and the compound‐delivery system produced were extensively mapped and analyzed.
+
+Developing functional restorative materials has gained efforts in the field of dental materials. Caries lesions adjacent to direct restorative dental materials, such as resin composites, have been considered the main cause of restoration failure (Askar et al. 2021). Once caries is a biofilm‐dependent disease, researchers in the dental materials field are motivated to develop materials with antibacterial properties, which might reduce the incidence of recurrent caries and restoration replacement (Barot et al. 2020).
+
+A significant adjunct in the development of materials with antibacterial properties is nanocarriers, which have shown great potential for use in various fields, with the strategy of safely delivering local functional compounds, compatible with the requirements of each presentation form (Dong et al. 2021). Nanostructured clays stand out as nanomaterials with a layered structure, which allows for the intercalation and adsorption of molecules within their framework (Elmergawy et al. 2021; Dong et al. 2021). Additionally, most nanostructured clays possess hydrophilic properties and a high cation exchange capacity, facilitating interaction with different functional compounds and their controlled release (Park et al. 2016). The difference in the morphology of nanostructured clays influences functional compound loading, with the reduction in clay dimensions to the nanoscale improving performance, availability, and controlled release (Dong et al. 2021). These nanostructured clays are ultra‐thin polar materials on the nanometer scale (Villalba‐Rodríguez et al. 2021).
+
+To improve the binding of functional compounds with nanostructured clays, surface modification might be a promising strategy. These modifications can enhance substance attachment, increase stability, and reduce nonspecific interactions (Li et al. 2019). Differences in the internal and external surfaces of nanostructured clays may create distinct compositions, fostering stronger interactions between the nanostructured clays and functional compounds (Riela et al. 2014). Techniques such as chemical processes, thermal treatments, or mechanical alterations that modify particle size and surface properties can be applied for this purpose (de Abreu Pereira et al. 2021). However, none of the studies reviewed in this paper employed surface treatments to boost adhesion or stabilize these interactions. The functional compounds tested in the primary studies likely had great affinity to the nanostructured clays tested.
+
+This scoping review identified that MMT had been the most commonly used nanostructured clay for delivering functional compounds in direct restorative dental materials. MMT (Figure 2) is a type of aluminosilicate nanostructured clay composed of crystalline layers formed by silicon oxide and aluminum hydroxide with hydrophilic properties and a high cation exchange capacity (Elmergawy et al. 2021; Dong et al. 2021). This cationic capacity is higher compared to other silicates, and its layers provide ample space for molecule binding, an important characteristic of compound adhesion (Dong et al. 2021). Due to the affinity of MMT for polar molecules (Park et al. 2016), such as chlorhexidine digluconate and CPC, its adsorption capacity is increased, which contributes to the retention and controlled release of functional compounds with polar characteristics. Thus, MMT exhibits hydrophilic characteristics, showing swelling in the presence of water, which contributes to the formation of a gelatinous material when combined with functional compounds (Ritto et al. 2022; Dong et al. 2021; Park et al. 2016).
+
+Another nanostructured clay identified as a carrier for functional substances in the present study was HNTs (Figure 3). They are tubular‐shaped, two‐layered aluminosilicate structures, presenting a porous appearance (Barot et al. 2020; Fizir et al. 2018). HNTs have aluminol on the inner side and siloxane on the outer side, which confer positive and negative charges, respectively (Timbó et al. 2024), allowing conjugation with polar and apolar compounds. The stability of the halloysite surface is due to the presence of anionic organic substances. The surface of HNT has selectivity that allows for various surface treatments to enhance properties such as porosity and surface contact area, which facilitate the incorporation of active agents for controlled release (de Abreu Pereira et al. 2023). Both MMT and HNTs can be employed in the loading and delivery of functional compounds, as they are considered significantly safe, with low cytotoxic potential, and biocompatible (Ritto et al. 2022; Barot et al. 2020). Due to these characteristics, these two nanostructured clays were the primary choices as carrier functional compounds in direct restorative dental materials. Although both nanostructured clays play an excellent role as functional compound carriers, MMT loaded with chlorhexidine (Boaro et al. 2019) was able to release the active ingredient for 28 days, which was the longest duration observed in the experiment. This may be a favorable characteristic for choosing the MMT, besides its chemical compatibility with CLX. On the other hand, HNTs present a moderate increase in the tube diameter after loading with farnesol (Barot et al. 2020), which led to a decrease in mechanical properties. Thus, the agglomeration of HNTs may hinder the interaction between the nanostructured clay and the polymeric matrix.
+
+Among the functional compounds used in the analyzed studies, cetylpyridinium chloride (CPC) was the most prevalent (60% of studies). CPC is a monocationic compound of quaternary ammonium (QAC), which is also a cationic surfactant similar to chlorhexidine (CHX) with broad‐spectrum antimicrobial activity against bacteria and fungi (Mao et al. 2020; Urakawa et al. 2020; Brezhnev et al. 2023). CPC is an antimicrobial ingredient commonly used in over‐the‐counter products, aiming to reduce biofilm accumulation and gingival inflammation (Mao et al. 2020; Urakawa et al. 2020). Another factor justifying the use of CPC is its good solubility in water, which facilitates manipulation with nanostructured clays, which, as previously shown, are materials with excellent adsorption properties to polar molecules (Mao et al. 2020). Once CPC is less affected by dilution and saliva (Urakawa et al. 2020), it is indicated for oral dosing with sufficient antimicrobial effect. The data showed in the primary studies included in the present scoping review evidenced that CPC has an antibacterial effect against caries‐related microorganisms (Matsuo et al. 2019; Yamamoto et al. 2022; Otsubo et al. 2023). Previous investigations (Mao et al. 2020; Smith et al. 2013) in oral mouthwashes further support CPC's effectiveness, showing that even at low concentrations, below 1%, CPC is effective against S. mutans and methicillin‐resistant Staphylococcus aureus (MRSA), common in the oral microbiota associated with dental caries.
+
+Data analysis revealed that two other important antimicrobial agents, farnesol and chlorhexidine, were identified in the primary studies included in this scoping review, each representing 20% of the total studies. Chlorhexidine is an antimicrobial agent widely used in various medical areas, such as dermatology and surgery, as well as in dentistry, due to its bactericidal action, aiding in biofilm reduction and gingival inflammation (Liu et al. 2023). Additionally, it is considered the gold standard of oral antiseptics due to its bactericidal and bacteriostatic activities (Arathi et al. 2019). CLX is used in saline forms such as acetate, digluconate, and dihydrochloride to allow miscibility in water (Chronopoulou et al. 2016), and its conjugation to MMT. Conversely, farnesol is a naturally occurring organic compound certified as GRAS (Generally Regarded as Safe), used as a flavoring agent and food additive, which has three carbon–carbon double bonds and exists in four isomers. Farnesol exhibits lipophilic properties and antifungal and antibacterial effects (Barot et al. 2020; Hornby et al. 2001; Horev et al. 2015).
+
+Nanocarriers have proven to be an excellent approach to allow localized and controlled delivery of functional compounds. After mapping the literature, MMT and HNTs emerged as a prominent choice as a nanocarrier by effectively entrapping and gradually releasing the functional compounds, owing to their unique properties such as layered structure and cation exchange capacity. Other non‐nanoclay delivery systems, such as polymeric nanoparticles loaded with chlorhexidine, have emerged as a viable strategy for the sustained release of antimicrobial agents for 28 days. This performance results from the combination of high encapsulation efficiency, small particle size with uniform morphology, and effective in vitro controlled release behavior (Priyadarshini et al. 2017). Thus, further synthesis studies can focus on comparing the efficacy of nanoclays and polymeric‐based delivery systems.
+
+The hydrophobic characteristic of the antibacterial compound influence on which nanostructured clay would be chosen for conjugation without any surface treatment. Antimicrobial agents such as CPC, farnesol, and chlorhexidine were effective in inhibiting cariogenic microorganisms and reducing biofilms. They demonstrated efficacy in release and antibacterial action without disrupting the integrity of the direct restorative dental materials into which they were incorporated. Overall, the incorporation of the functional compounds involved dissolving the nanocarrier powder and then incorporating the agent into this solution for subsequent drying.
+
+This scoping review is distinguished by its innovative approach in mapping and analyzing the use of nanostructured clays in direct restorative dental materials for controlled functional compounds release. While it provides valuable insights into the properties of nanostructured clays and their incorporation into direct restorative dental materials, which are extensively discussed in the literature, it is essential to recognize the limitations due to the scarcity of studies considering them as carriers of functional compounds in these dental materials. Over the past 5 years, only a few studies (n = 5) have explored the use of nanostructured clays as carriers for these functional compounds to formulate antibacterial direct restorative dental materials.
+
+Developing materials with nanocarriers has been a crucial tool in addressing the issue of caries adjacent to tooth restorations, highlighting the need for more in vitro studies to further advance anticaries direct restorative dental materials. Detailed methodologies for material manipulation are crucial for this development. The poor details reported in the primary studies raised the need that future research in this area to provide comprehensive descriptions of proportions, materials, and analyses to enable replication of the studies. Establishing a solid foundation of evidence on the mechanical properties and controlled release of antimicrobial agents is essential to support the development of clinical studies.
+
+Although this scoping review did not aim to make clinical recommendations but rather to synthesize the existing literature of a theme, it is important to note that the overall risk of bias in the included studies was moderate. This finding is primarily attributed to methodological shortcomings observed in several of the in vitro studies analyzed. Thus, it becomes even more essential to advocate for the standardization of material characterization protocols in future investigations. Universal testing approaches are critical to ensure the scientific reliability and clinical translational potential of the materials being developed. The development of specific guidelines could solve the gap.
+
+Future studies are encouraged to extend the observation period of controlled release assays to provide stronger support for the development of subsequent clinical investigations. In addition to the in vitro studies already proposed, clinical trials are essential to determine whether the incorporation of nanostructured complexes with antibacterial function can effectively prevent or reduce the occurrence of caries lesions adjacent to the restorative material, an outcome that represents the true purpose of designing antibacterial restorative systems. However, the clinical translation of such materials still depends on further in vitro and in vivo studies to refine their properties and ensure their safety and effectiveness. Moreover, conducting clinical trials presents several challenges, including the need for long‐term follow‐up, potential patient dropout, and the complexity of developing and standardizing novel restorative materials, factors that require careful planning and robust study designs.
+
+This scoping review contributes to a broader understanding of how these materials can be applied to enhance the antibacterial effect of direct restorative dental materials, exploring the advancements in the use of nanostructured clays.
+
+5 Conclusion
+
+MMT and HNTs were the main nanostructured clays used for controlled release of functional compounds in direct restorative dental materials. Although MMT is the most commonly used in studies, the literature suggests that HNTs possess properties that facilitate the incorporation of both hydrophilic and hydrophobic compounds without the need for prior treatment, due to their dual layers with different charges. These nanostructured clays, combined with cetylpyridinium chloride, chlorhexidine, and farnesol, demonstrated efficient aggregation. The functional compound‐nanostructured clay systems showed no material degradation, retained good mechanical properties, and were effective against caries‐related oral bacteria without cytotoxicity. Functional compounds were incorporated at concentrations up to 10 wt%, maintaining material integrity and effectiveness, indicating potential for future research. Despite the limited number of studies published in recent years, this review aims to encourage further research by highlighting existing gaps, particularly the need for more in vitro investigations and the promotion of clinical studies using the developed materials. Such efforts are essential to better understand the antibacterial activity of these materials and their potential to prevent or reduce the occurrence of caries lesions adjacent to restorations.
+
+Author Contributions
+
+Bárbara Faria de Sa Barbosa: data curation, investigation, methodology, writing – original draft. José Leôncio Ferreira Neto: data curation, investigation, methodology, writing – original draft. Francisca Jennifer Duarte de Oliveira: data curation, methodology, writing – original draft. Juliana Sales Osterno Leitão: writing – original draft. Moan Jéfter Fernandes Costa: supervision, writing – review and editing. Pedro Henrique Sette‐de‐Souza: supervision, writing – review and editing. Pierre Basílio Almeida Fechine: supervision, writing – review and editing. Victor Pinheiro Feitosa: supervision, writing – review and editing. Boniek Castillo Dutra Borges: conceptualization, supervision, writing – review and editing.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Data Availability Statement
+
+The authors have nothing to report.
+
+
+References
+
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diff --git a/corpus/healthcare/text/b6926ea1d050ece7.txt b/corpus/healthcare/text/b6926ea1d050ece7.txt
new file mode 100644
index 0000000000000000000000000000000000000000..0f498e659e780b08a5957998146ba53adaea91cc
--- /dev/null
+++ b/corpus/healthcare/text/b6926ea1d050ece7.txt
@@ -0,0 +1,309 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Rev Bras Enferm
+Journal ID: Rev Bras Enferm
+NLM Journal ID: 7910105
+Journal ID: reben
+
+Revista Brasileira de Enfermagem
+
+ISSN: 0034-7167
+EISSN: 1984-0446
+Publisher: Associação Brasileira de Enfermagem
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC10895783
+PMID: 38422310
+DOI: 10.1590/0034-7167-2023-0134
+Article ID: 00302
+Article version: 1
+Subjects: Review
+
+Evidence of intrauterine device insertion by nurses in Primary Health Care: an integrative review
+
+Evidencias de inserción de dispositivos intrauterinos por parte de enfermeros en Atención Primaria de Salud: revisión integradora
+
+Evidências da inserção de dispositivo intrauterino por enfermeiros na Atenção Primária à Saúde: revisão integrativa
+
+http://orcid.org/0000-0002-6882-7691 de Oliveira Lays Souza conception or design of the study/research analysis and/or interpretation of data final review with critical intellectual participation in the manuscript. I
+http://orcid.org/0000-0002-7969-357X Hermida Patrícia Madalena Vieira conception or design of the study/research analysis and/or interpretation of data final review with critical intellectual participation in the manuscript. I
+http://orcid.org/0000-0002-9526-9939 Siqueira Elizimara Ferreira final review with critical intellectual participation in the manuscript. I
+http://orcid.org/0000-0002-2594-656X de Arma Juliana Cipriano Braga Silva final review with critical intellectual participation in the manuscript. I
+http://orcid.org/0000-0002-5890-8105 Thomas Larissa Scheeren analysis and/or interpretation of data final review with critical intellectual participation in the manuscript. I
+http://orcid.org/0000-0002-6611-4970 Dalmolin Indiara Sartori final review with critical intellectual participation in the manuscript. I
+I Prefeitura Municipal de Florianópolis. Florianópolis, Santa Catarina, Brazil
+Corresponding author: Lays Souza de Oliveira, E-mail: enf.laysoliveira@gmail.com EDITOR IN CHIEF: Dulce Barbosa
+
+ASSOCIATE EDITOR: Ana Fátima Fernandes
+
+Electronic publication date: 2024 Feb 26
+Publication date: 2024
+Volume: 77
+Issue: 1
+Electronic Location ID: e20230134
+Received 2023 May 27; Accepted 2023 Oct 9
+License: This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Intrauterine Devices, Nurses, Primary Health Care, Advanced Practice Nursing, Long-Acting Reversible Contraception
+Keywords: Dispositivos Intrauterinos, Enfermeros, Atención Primaria de Salud, Enfermería de Práctica Avanzada, Anticoncepción Reversible de Larga Duración
+Keywords: Dispositivos Intrauterinos, Enfermeiros, Atenção Primária à, Saúde, Prática Avançada de Enfermagem, Contracepção Reversível de Longo Prazo
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Objectives:
+
+to synthesize and analyze evidence on intrauterine device insertion by nurses in Primary Health Care.
+
+Methods:
+
+an integrative review, carried out in the BDENF, CINAHL, LILACS, SciELO, Scopus, PubMed and Web of Science databases in June 2022, delimiting the period from 1960 to 2022.
+
+Results:
+
+141 articles were identified in the initial search, and 10 studies made up the final sample. Four (40%) were developed in the United States and one (10%) in Brazil, with publications from 1979 to 2021. The findings were grouped into three categories: Nurse training to insert an intrauterine device; Nurses’ competency to insert an intrauterine device; and Women’s access to intrauterine devices.
+
+Conclusions:
+
+nurse theoretical and practical training is a prominent element, consolidated in the favorable outcomes of insertions performed by nurses and satisfaction among women, a practice that has expanded access to the contraceptive method in Primary Health Care.
+
+RESUMO
+
+Objetivos:
+
+sintetizar e analisar as evidências da inserção de dispositivo intrauterino por enfermeiros na Atenção Primária à Saúde.
+
+Métodos:
+
+revisão integrativa, realizada nas bases de dados BDENF, CINAHL, LILACS, SciELO, Scopus, PubMed e Web of Science em junho de 2022, delimitando-se o período de 1960 a 2022.
+
+Resultados:
+
+identificaram-se 141 artigos na busca inicial, e 10 publicações compuseram a amostra final. Quatro (40%) foram desenvolvidos nos Estados Unidos e um (10%) no Brasil, sendo publicações de 1979 a 2021. Os achados foram agrupados em três categorias: Treinamento dos enfermeiros para inserção de dispositivo intrauterino; Competência dos enfermeiros para inserção de dispositivo intrauterino; e Acesso das mulheres aos dispositivos intrauterinos.
+
+Conclusões:
+
+o treinamento teórico e prático dos enfermeiros é um elemento de destaque, consolidado nos desfechos favoráveis das inserções realizadas por enfermeiros e satisfação entre as mulheres, prática que tem ampliado o acesso ao método contraceptivo na Atenção Primária à Saúde.
+
+RESUMEN
+
+Objetivos:
+
+sintetizar y analizar la evidencia sobre la inserción de dispositivos intrauterinos por parte de enfermeras en la Atención Primaria de Salud.
+
+Métodos:
+
+revisión integrativa, realizada en las bases de datos BDENF, CINAHL, LILACS, SciELO, Scopus, PubMed y Web of Science en junio de 2022, delimitando el período de 1960 a 2022.
+
+Resultados:
+
+se identificaron 141 artículos en la búsqueda inicial y 10 publicaciones conformaron la muestra final. Cuatro (40%) fueron desarrollados en Estados Unidos y uno (10%) en Brasil, con publicaciones de 1979 a 2021. Los hallazgos se agruparon en tres categorías: Capacitación de enfermeras para insertar un dispositivo intrauterino; Competencia de las enfermeras para insertar un dispositivo intrauterino; y Acceso de las mujeres a los dispositivos intrauterinos.
+
+Conclusiones:
+
+la formación teórica y práctica de los enfermeros es un elemento destacado, consolidado en los resultados favorables de las inserciones realizadas por los enfermeros y la satisfacción de las mujeres, práctica que ha ampliado el acceso al método anticonceptivo en la Atención Primaria de Salud.
+
+INTRODUCTION
+
+Long-acting reversible contraception (LARC) has been motivating new public health policies worldwide in an attempt to overcome the rates of unwanted pregnancies, abortions and maternal mortality(1), highlighting, among them, the intrauterine device (IUD), object of this study.
+
+The IUD, made of solid material, usually in the shape of a T, is placed in the uterine cavity and aims to prevent pregnancy. It is available in different configurations, the main ones being the copper IUD and the levonorgestrel-releasing intrauterine system (LNG-IUS). In Brazil, the Ministry of Health (MoH) makes copper IUD available free of charge through the Brazilian Health System (SUS - Sistema Único de Saúde)(2).
+
+From this perspective, the eligibility criteria for the use of each contraceptive method must be considered. The copper IUD and the hormonal IUD can be offered to most women, nulliparous and multiparous, after vaginal or cesarean birth, after abortion in the first trimester, for adolescents and women in perimenopause. For those who have contraindications to hormonal methods, the copper IUD is an option(3-5).
+
+IUD are advantageous because they are easily reversible, have low pregnancy rates, few unwanted effects, do not depend on frequent maintenance users’ behaviors and have local (intrauterine) action. Specifically about the copper IUD, it is more cost-effective, effective for up to 10 years, and can be used as an emergency contraceptive, having no effect on lactation or sexual function(3,6). Furthermore, its mechanism of action does not use hormones, an advantage that, in most cases, is the main criterion for choice among women(7). LNG-IUS has the specific advantages of being effective for up to five years, reducing menstrual volume and colic, and can be used as a treatment for excessive bleeding(5).
+
+Despite the advantages, LARC are underused around the world. According to a United Nations study(8), the estimated prevalence of IUD use among women of reproductive age (15-49 years) in 2019 was 8.4% worldwide, with 10.7% in Asia, 8.1% in Europe, 7.6% in America North, 4.6% in Latin America and the Caribbean, 3.4% in Oceania and 2.6% in Africa. Among the barriers to using the method, organizational, such as low availability of the method or high number of criteria for its insertion, lack of institutional protocols, restriction of nurses’ performance or limitation in the training of professionals, and individual, especially the low level of knowledge about the method, stand out(1,9).
+
+Evidence shows that nurses have a relevant role in IUD insertion in different locations around the world, such as Australia(10), the United States(11-12), England(13), India(14) and Brazil(15). In the country, nurses have had their practice regulated by the Federal Nursing Council (COFEN - Conselho Federal de Enfermagem) since 2010, which states that this professional has the capacity and legal competency to insert and remove the IUD after qualification and training(16). In 2022, a new resolution began to standardize this practice of nurses, providing for their competencies regarding device insertion, review and removal, including detailing training time and the places where they work for reproductive planning actions, such as in Primary Health Care (PHC)(17).
+
+PHC constitutes an important setting for offering IUD, as it is the main gateway into health systems, highlighting the importance of nurses in planning and reproductive health actions in this care space, through guidance on contraceptive methods, contributing to expanding women’s access to IUD(1,6).
+
+Considering the above, considering that unwanted pregnancy remains a public health problem and that regulation of IUD insertion practice by nurses in Brazil is an object of constant discussion, this study is justified by the possibility of knowing the scientific evidence of device insertion by PHC nurses worldwide, which could contribute to strengthening this advanced practice of nurses in this care scenario for its legal support and institutional consolidation as well as expanding access to IUD through nurses’ actions so that new research on the topic can be envisioned.
+
+OBJECTIVES
+
+To synthesize and analyze evidence of IUD insertion by nurses in PHC.
+
+METHODS
+
+This is an integrative literature review, which followed the steps suggested by Ganong(18) (1987): 1) review objective formulation and guiding question selection; 2) determination of inclusion and exclusion criteria for the literature search; 3) search and selection of primary studies, arranging them in tables and organizing common ideas; 4) critical analysis of included studies; 5) data discussion and interpretation; and 6) clear and complete review presentation.
+
+In the first stage, the guiding question of this review was defined as: what is the evidence on IUD insertion by nurses in PHC? Then, the eligibility criteria for the studies were defined, including original research, experience reports, case and review studies, with a quantitative or qualitative approach, published from 1960 to 2022, in an indexed journal, in article format and in Portuguese, English or Spanish, and which had PHC nurses as participants, even if not exclusively. Exclusion criteria included letters, editorials, theses, dissertations, monographs, books, works unavailable in full electronically or in print and those not related to the topic of study or that do not answer the research question, in addition to duplicate studies in the databases. The research time frame is justified by the fact that scientific literature records the first IUD insertions by nurses in the world in the 1960s(19).
+
+The searches were conducted in June 2022, using advanced search tool in the databases: Nursing Database (BDENF); Cumulative Index to Nursing and Allied Health Literature (CINAHL); Embase; Latin American and Caribbean Literature in Health Sciences (LILACS); Scientific Electronic Library Online (SciELO); Scopus; U.S. National Library of Medicine (PubMed); and Web of Science (WOS) via Virtual Private Network (VPN) from the Universidade Federal de Santa Catarina (UFSC).
+
+To define the descriptors, the terms systematized in the Health Sciences Descriptors (DeCS) and the Medical Subject Headings (MeSH) were used. Different combinations of Boolean operators “AND” and “OR” were used to identify the largest number of articles possible. The search strategy was adapted for each database according to its specificities, which was carried out by the researcher together with a librarian from UFSC (Chart 1).
+
+Chart 1 Databases with their respective search strategies
+
+Databases and search strategies	
+BDENF and LILACS
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs” OR “Dispositivos Intrauterinos” OR “Anticoncepcionais Intrauterinos” OR “Dispositivo Intrauterino” OR “Anticonceptivos Intrauterinos” OR “Contraceptivos Intrauterinos”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse” OR “Cuidados de Enfermagem” OR “Enfermagem” OR enfermeir* OR “Atención de Enfermería” OR “enfermeria” OR enfermer* ) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing” OR “Atenção Primária à Saúde” OR “Atenção Básica” OR “Atenção Primária” OR “Atendimento Básico” OR “Atendimento Primário” OR “Cuidados de Saúde Primários” OR “Cuidado de Saúde Primário” OR “Cuidados Primários” OR “Cuidado Primário” OR “Cuidado de Saúde Básico” OR “Cuidados de Saúde Básicos” OR “Cuidado Básico” OR “Cuidados Básicos” OR “Enfermagem de Atenção Primária” OR “Atención Primaria de Salud” OR “Atención Primaria” OR “Atención Básica” OR “Cuidado de la Salud Primarios” OR “Cuidados Primarios” OR “servicios básicos de salud” OR “servicio básico” OR “servicios básicos” OR “cuidado básico de salud” OR “cuidados básicos de salud” OR “Enfermería de Atención Primaria”)	
+CINAHL
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse”) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing”)	
+EMBASE
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse”) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing”	
+SciELO
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs” OR “Dispositivos Intrauterinos” OR “Anticoncepcionais Intrauterinos” OR “Dispositivo Intrauterino” OR “Anticonceptivos Intrauterinos” OR “Contraceptivos Intrauterinos”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse” OR “Cuidados de Enfermagem” OR “Enfermagem” OR enfermeir* OR “Atención de Enfermería” OR “enfermeria” OR enfermer* ) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing” OR “Atenção Primária à Saúde” OR “Atenção Básica” OR “Atenção Primária” OR “Atendimento Básico” OR “Atendimento Primário” OR “Cuidados de Saúde Primários” OR “Cuidado de Saúde Primário” OR “Cuidados Primários” OR “Cuidado Primário” OR “Cuidado de Saúde Básico” OR “Cuidados de Saúde Básicos” OR “Cuidado Básico” OR “Cuidados Básicos” OR “Enfermagem de Atenção Primária” OR “Atención Primaria de Salud” OR “Atención Primaria” OR “Atención Básica” OR “Cuidado de la Salud Primarios” OR “Cuidados Primarios” OR “servicios básicos de salud” OR “servicio básico” OR “servicios básicos” OR “cuidado básico de salud” OR “cuidados básicos de salud” OR “Enfermería de Atención Primaria”)	
+Scopus
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse”) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing”)	
+PubMed
+(“Intrauterine Devices”[Mesh] OR “Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs” OR “Intrauterine Devices, Copper”[Mesh]) AND (“Nursing Care”[Mesh] OR “Nursing Care” OR “Nursing”[Mesh] OR “Nursing” OR “Nursings” OR “Nurses”[Mesh] OR “Nurses” OR “Nurse”) AND (“Primary Health Care”[Mesh] OR “Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing” OR “Primary Care Nursing”[Mesh])	
+Web of Science
+(“Intrauterine Devices” OR “Contraceptive IUD” OR “Contraceptive IUDs” OR “Intrauterine Contraceptive Device” OR “Intrauterine Contraceptive Devices” OR “Intrauterine Device” OR “Unmedicated IUD” OR “Unmedicated IUDs”) AND (“Nursing Care” OR “Nursing” OR “Nursings” OR “Nurses” OR “Nurse”) AND (“Primary Health Care” OR “Primary Healthcare” OR “Primary Care” OR “basic health care” OR “basic care” OR “basic service” OR “Primary Care Nursing”)	
+
+After searching the databases, all citations found were exported to the Rayyan - Intelligent Systematic Review web application, developed by the Qatar Computing Research Institute (QCRI), to assist in study selection and organization. Rayyan QCRI consists of a tool that helps in exploring and filtering searches for studies eligible for systematic reviews, mainly in the title and abstract screening phase. It allows assessing studies with the blinding of the assistant reviewer, which contributes to reliability in information selection and methodological accuracy(20). Subsequently, duplicate studies were excluded.
+
+To select the articles that constituted the sample, two independent researchers read the titles and abstracts. From this, both read the studies in full, which were selected based on inclusion and exclusion criteria. It is worth noting that the studies that presented decision-making conflicts in the selection process were analyzed by a third researcher. Furthermore, the Statement for Reporting Systematic Review and Meta-Analyses of Studies (PRISMA) checklist recommendations were used to select studies(21), as shown in Figure 1.
+
+Figure 1 Flowchart for identification and selection of studies, prepared based on PRISMA recommendation
+
+To organize and analyze the data, the researcher created a spreadsheet in Google Spreadsheets® with the data: title; year of publication; country where the research was carried out; study design; objective; participants; main results; conclusion; and level of evidence. Each study received an identification code composed of the letter “S” followed by an Arabic number (S1, S2…).
+
+For critical analysis of results, interpretation of findings and discussion, the themes that emerged were subdivided into three categories: Nurse training to insert an intrauterine device; Nurses’ competency to insert an intrauterine device; and Women’s access to intrauterine devices.
+
+Regarding the level of scientific evidence of the studies, the classification into seven levels was applied: level I, evidence from a systematic review or meta-analysis of all relevant randomized controlled clinical trials (RCTs); level II, evidence from controlled RCTs with good design; level III, evidence derived from well-designed clinical trials without randomization; level IV, evidence obtained from well-designed cohort and case-control studies; level V, evidence resulting from a systematic review of descriptive and qualitative studies; level VI, evidence from a single descriptive or qualitative study; level VII, evidence originating from authority opinion and/or reports from expert committees(22).
+
+The present study, as it is an integrative literature review, did not require approval from the Research Ethics Committee, however all ethical aspects provided for in Law 9,610/98 on copyright were considered, such as citing the authors of selected articles and preserving the ideas, concepts and findings presented in the investigations(23).
+
+RESULTS
+
+Initially, a total of 141 studies were identified, of which 10 constituted the final sample of the present review. Of this sample quantity, four (40%) studies were developed in the United States, three (30%) in England, one (10%) in Burkina Faso, one (10%) in the Philippines, and one (10%) in Brazil, which was carried out in the city of Florianópolis, Santa Catarina. The temporal variation between the first and last publication was 42 years (1979 - 2021), with only three (30%) published in the last five years (Chart 2).
+
+Chart 2 Characteristics of studies that made up the review sample, Florianópolis, Santa Catarina, Brazil, 2022
+
+Code	Title	Year/country of origin	Study design/LoE	Participants	
+S1(24)	The Bohol IUD program	1979/Philippines	Experience report/VII	Nurses * (n=40) and midwives (n=40)	
+S2(25)	The effectiveness of non-physicians as providers of family planning services	1979/United States	Literature review/VII	Not applicable	
+S3(26)	Managing change in primary care: part 1	2008/England	Experience report/VII	Nurse * (n=1)	
+S4(27)	Managing change in primary care: part 2	2009/England	Experience report/VII	Nurse * (n=1)	
+S5(28)	Managing change in primary care: part 3	2009/England	Experience report/VII	Nurse * (n=1)	
+S6(29)	Counseling and provision of long-acting reversible contraception in the US: National survey of nurse practitioners	2013/United States	Probability survey/VI	PHC (n=224) and women’s health (n=360) nurses	
+S7(30)	Long-acting reversible contraceptives for teenagers: Primary care recommendations	2015/United States	Literature review/VII	Not applicable	
+S8(31)	Establishing and conducting a regional, hands-on long-acting reversible contraception training Center in primary care	2018/United States	Experience report/VII	Family * and pediatric nurses (n=28)	
+S9(32)	Evaluation of a pilot program for task sharing short and long-acting contraceptive methods in Burkina Faso	2020/Burkina Faso	Descriptive study of mixed methods/VI	Nurses * (n=16) and registered midwives (n=8), assistant midwives (n=29), mobile health professionals (n=26), totaling 79 primary care professionals.	
+S10(15)	Inserção de DIU por enfermeiros da Atenção Primária à Saúde	2021/Brazil	Experience report/VII	PHC nurses (n=115)	
+LoE - level of evidence; PHC - Primary Health Care;
+* preserved the nomenclature of participants used in the studies, whose operating scenario was Primary Health Care.
+
+The majority (n=9; 90%) of studies were published in international scientific journals and in English. There is a predominance of experience report studies (n=6; 60%), followed by literature reviews (n=2; 20%) and quantitative or mixed methods research (n=2; 20%). Regarding the levels of evidence, it is highlighted that eight (80%) studies have level VII. As for participants, nurses (n=5; 50%), PHC nurses (n=2; 20%), family nurses (n=1; 10%), women’s health nurses (n=1; 10%) and pediatrics (n=1; 10%) were the main study subjects (n=8; 80%), since, in two (20%), as they are literature reviews, this information is disregarded (Chart 2).
+
+The main results in relation to evidence of IUD insertion by nurses in PHC, the objectives of studies and the synthesis of the respective conclusions are found in Chart 3.
+
+Chart 3 Studies selected for review according to objectives, main results and conclusion, Florianópolis, Santa Catarina, Brazil, 2022
+
+Code	Objectives	Main results	Conclusion	
+S1(24)	To report the proposal for an IUD program that used midwives and nurses to perform the insertions.	The six-week IUD trainings involved ten nurses and ten midwives in each class. They formed four classes in 1977 and 1978, totaling 80 participants, who learned everything from contraindications to IUD insertion and removal. Each professional needed to insert 20 IUD to be considered qualified. Of the total insertions, 63% occurred in the women’s homes. More than 2,000 IUD were inserted, and there were no serious complications related to the insertions.	Nurses and midwives can safely insert IUD. Device insertion by these trained professionals increased the acceptability of the method, due to women’s bond and trust, in addition to the availability of professionals to perform the procedure at home.	
+S2(25)	To review the literature on the role of non-medical professionals as primary care providers in family planning.	In the USA, since the National Family Planning Act in 1970, nurses have received training to work in planning and women’s health. In 1967, removal, expulsion, retention, and pregnancy rates after IUD insertion in 210 women showed lower rates of expulsion and removals and higher retention rates among women who had IUD inserted by nurses (n=150) when compared to insertions by physicians (n=60). Regarding IUD insertion by physicians, obstetric nurses and rural midwives, there were no complications and significant differences between professionals. Countries such as Korea, Nigeria and Pakistan have been encouraging the training of non-physicians to insert IUD, aiming to reduce birth rates and improve access to contraception in rural areas.	Non-physicians’ ability to safely insert IUD is advocated, as they have greater acceptability and accessibility by vulnerable populations when compared to physicians. The literature reveals that there was no apparent difference in relation to IUD complications and maintenance between physicians and non-physicians. It is recommended that public services train and expand the role of nurses in family planning.	
+S3(26)	To describe the rationale for the strategies used to introduce a nurse-led service to improve LARC access and discuss the effectiveness, cost-effectiveness and training for IUD insertion.	To provide a more comprehensive and accessible family planning service, the project relies on clear evidence that nurses are competent to acquire IUD insertion skills as well as reducing costs to the practice. The Royal College of Nursing recommends that nurses insert at least five IUD and remove two IUD per year to maintain their competency.	Guidance on training and practices for IUD insertion is based on comprehensive evidence and provides a clear framework for ongoing training and practice. There is disparity in access to training, however training nurses is more economical, and they are competent in the procedure when compared to physicians.	
+S4(27)	To describe the project presentation to physician partners to introduce a nurse-led service for IUD and IUS insertion into practice and the steps required to have the clinic up and running.	A practical nurse with criteria for the role of trainer was trained by a physician to insert IUD and IUS. Practically, there was no difference between counseling and IUD insertion between physicians and nurses, except that nurses have a trained assistant. Three consultations were scheduled: the first, lasting 10 minutes, for advice, assessment and decision on the device to be inserted; in the second, lasting 20 minutes, the IUD or IUS was inserted; and after 6 weeks, a new consultation took place to check the device wires, assess bleeding and satisfaction with the method.	The success of project implementation depended in part on its application in practice, related to patients’ needs within the multidisciplinary environment.	
+S5(28)	To report the successful introduction of a nurse-led service to improve contraceptive choice, reflecting problems encountered, what was achieved and aspects of leadership in action.	The plan to develop a skill historically dominated by the medical profession was initially met with opposition. Different leadership styles were used to facilitate service implementation, and culture was identified as an important facilitator in this process. A satisfaction survey was used which revealed that patients did not attribute IUD insertion exclusively to physicians, but understood that all nurses trained in family planning already performed this procedure.	Obtaining competency in IUD/IUS insertion improved family planning skills, in addition to enabling the training of other nurses. Publication of the experience and lectures at events increased interest in the subject and inspired many nurses to train on their own.	
+S6(29)	To assess practice and training needs to prepare nurses to provide highly effective contraceptives such as IUD and implants.	Of the nurses participating in the study, 86% were trained in family planning, almost all of them working in the area of women’s health (97%). PHC nurses had greater limitations in their IUD insertion skills, with 12% of them and 72% of women’s health nurses feeling comfortable performing the procedure. IUD were most often offered by women’s health nurses, and 72% of them and 30% of PHC nurses reported including IUD in discussions with patients. The desire for training on IUD insertion was expressed by 35% of PHC nurses and 20% of women’s health nurses. The latter had more knowledge about the contraindications of the method.	Nurses provide care to vulnerable women of reproductive age in PHC settings, such as health centers as well as community family planning clinics. To address the persistent problem of unwanted pregnancy, it is essential to train nurses who provide contraceptive care to offer the most effective methods.	
+S7(30)	To discuss barriers to underuse of long-acting reversible contraceptive methods (LARC) and present an evidence-based approach to the use of these methods among adolescents in PHC.	Barriers to IUD acceptance are identified, such as lack of professional training, pain during insertion and procedure costs. Contraception is considered an essential preventive care service, and this increases the need for PHC nurses to adequately provide this service. Skills-based training in LARC methods in advanced practice nursing and continuing education programs is critical to increasing access, delivery, and utilization by adolescents in primary care.	PHC nurses are responsible for meeting the contraceptive needs of adolescents, incorporating counseling and increasing access to IUD. Furthermore, they have the potential to impact the reproductive health outcomes of adolescents. It is important to increase training in LARC methods for professionals.	
+S8(31)	To describe the experience and lessons learned developing and conducting training of PHC professionals in contraception, including LARC insertion through the Hands-on Reproductive Health Training (HaRT) Center.	A total of 28 pediatric and family nurses, 13 physicians and four physician assistants were trained. Most entered training with few speculum handling skills and limited LARC knowledge and advice. During training, professionals inserted an average of eight IUD and removed an average of two. Everyone inserted at least one IUD and 80% of them removed the device. Only 41% of trainees consider themselves competent in inserting a copper IUD and 50% in inserting a hormonal IUD. However, more than 75% of them were considered competent by the coaches. After training, 32% of participants reported that they are providing IUD insertion and 35% of them are providing device removal.	Those who entered training with basic knowledge of gynecological examination procedures and skills developed their LARC skills more quickly. It was found that family nurses have more training in speculum and gynecological examination than pediatric nurses. Services need professionals trained to provide LARC.	
+S9(32)	To assess the pilot project that aimed to share long-term family planning service tasks with the primary care team and short-term with CHW.	A total of 79 primary care providers from 26 health centers received training to provide family planning services, including IUD insertion and removal. Around 78.6% of women who had an IUD inserted were very satisfied with the method and 17.1% were satisfied. Only 12% of undesirable effects and no reports of complications after IUD insertion were revealed. Some PHC services may have been overloaded with increased access to LARC, increasing waiting times for care or the need to seek another service to obtain IUD.	The results indicate that task sharing is viable and acceptable to increase access to family planning. Before expanding the task sharing intervention, IUD insertion training is recommended for a larger number of professionals. Furthermore, attention should be paid to establishments with insufficient resources to offer LARC.	
+S10(15)	To describe the experience of nurses implementing the copper IUD insertion service in PHC in Florianópolis, Santa Catarina.	A total of 115 nurses were qualified, including permanent professionals and residents. 2,024 IUD insertions by nurses were recorded in just over three years since the service was implemented. There was a 60% increase in access and offering the method to women. In the period analyzed, nurses were responsible for the majority of IUD insertions in the city, corresponding to 58.3% of the total procedures performed.	In PHC, IUD insertion by nurses has contributed to access to the method. In this context, nurse training positively influences the qualification of care. Furthermore, the reported practice has demonstrated efficacy and safety, and goes beyond hegemonic and medical-centered models.	
+IUD - intrauterine device; IUS - intrauterine system; PHC - Primary Health Care; LARC - long-acting reversible contraception; CHW - community health workers.
+
+From the analysis of studies(15,24-32), three categories emerged: Nurse training to insert an intrauterine device; Nurses’ competency to insert an intrauterine device; and Women’s access to intrauterine devices.
+
+Nurse training to insert an intrauterine device
+
+Different training experiences for IUD insertion and removal were evident [S1, S3, S4, S5, S6, S8, S9]. Note the variability of professionals who participated in training, such as nurses [S1, S9, S10], pediatric nurses [S8], family health nurses [S8], PHC nurses [S6, S10], community health nurse women [S6], resident nurses [S10], midwives [S1, S9] and physicians [S8]. Experiences show that the number of trained professionals ranged from 45 to 115 professionals [S1, S8, S9, S10]. Nurses were cited as training supervisors [S1, S4]. A study shows that nurse trainers are initially trained by a physician [S4].
+
+Studies also address the minimum number of IUD insertions necessary for the professional to be considered qualified, with a variation of one [S8], five [S3] and 20 [S1] device insertions and also removals, which ranged between one [S8] and two [S3].
+
+Nurses’ competency to insert an intrauterine device
+
+Nurses’ experiences with IUD practice reveal a significant number of device insertions in the Philippines and Brazil, where more than 2,000 [S1] and 2,024 [S10] insertions were performed, respectively. Furthermore, positive outcomes were evidenced, such as the absence of serious complications after the procedure [S1, S9], few undesirable effects [S9] and satisfaction among women [S5, S9]. Therefore, studies advocate IUD insertion by nurses, considering these professionals to be competent and qualified for the procedure [S3, S5, S7, S8, S10] as well as physicians [S2, S3, S4, S5].
+
+Women’s access to intrauterine devices
+
+The studies highlight barriers in access to reproductive planning services, such as the restriction of nurses’ work [S2], the lack of professional training [S3], the medical-centered training model [S8], the overload of some health services primary care and waiting time for care [S9]. On the other hand, IUD insertion by nurses proves to be a positive strategy to solve the problem of access to IUD [S2, S7, S9, S10].
+
+DISCUSSION
+
+The set of evidence analyzed allowed us to understand the factors that permeate IUD insertion by PHC nurses worldwide. Seen in these terms, the studies highlight nurse training and the competency that these professionals have to carry out IUD insertion as well as women’s access to this contraceptive method, aiming to reduce the frequent problem of unwanted pregnancy.
+
+The findings showed records of IUD insertion by nurses over 40 years ago(24-25) and, since then, different forms of training these professionals to perform the procedure have been documented(24,27,29,31-32). A study carried out in 1979 described how nurses and midwives were trained to insert and remove IUD, in which each professional needed to insert 20 devices to be considered qualified(24). Although the study is one of the oldest in this review, it has very current criteria on training, considering the current COFEN Resolution 690/2022, which updates the theoretical and theoretical-practical workload requirements in Brazil, expanded to a total 70 hours, establishing a minimum of 20 supervised IUD insertions for nurse certification(17).
+
+Of the studies analyzed, two(26,30) reflect on the importance of training for IUD and LNG-IUS insertion being based on evidence and the skills of professionals, aiming for a clear training program and comprehensive practice. In line with this, the recent experience of training nurses in a municipality in Brazil consists of a theoretical component with a workload of 30 hours, followed by insertion training in a simulator, case discussion and consent form. After clarifying all doubts, nurses must perform at least 20 supervised IUD insertions(33), which allows nurses to feel more confident during training and confident to perform the procedure after certification.
+
+Studies have also shown that participants who began training with basic knowledge and practice in gynecological examinations more quickly developed their skills in LARC procedures, in addition to improving their learning about contraceptive counseling, contraindications, IUD insertion and removal(24,31). Regarding skills in IUD insertion, research showed that PHC nurses demonstrated greater practical limitations in the procedure when compared to women’s health nurses, however 66% of these had received practical training for IUD insertion, different from those with only 12% of qualified(29).
+
+Still on the topic of training for IUD insertion and in line with the findings, a systematic review highlights that the knowledge of nurses and physicians improved from 58% to 81% after training, which was also positive for professionals’ self-confidence during the procedure(34). The literature mentions self-confidence as a consequence of Advanced Practice Nursing (APN), which is based on attributes such as evidence-based practice, a high level of autonomy and advanced and broad assessment(35), essential for IUD insertion by nurses. In this regard, it is noteworthy that an instrument was developed to assess nurses’ competency in inserting the device, a tool that can contribute to the qualification of these professionals(36) for Advanced Practice Nursing, given that the interventions resulting from this require specialized knowledge, the ability to make complex decisions and clinical skills for practice(37).
+
+Regarding the competency of nurses to insert IUD, mentioned in the studies, it is highlighted that, upon acquiring it, nurses can positively influence the reproductive planning of adult and adolescent women, qualification of care, in addition to enabling training other nurses(15,26,28,30), an aspect also considered an attribute of APN(35), overcoming hegemonic models and physician-centered(15,26,28,30). Research carried out in England, published in 1999, already revealed favorable evidence in this regard, highlighting that trained nurses perform efficient and safe IUD insertions, regardless of patients’ age, in addition to a better cost-benefit ratio(13).
+
+IUD insertion safety by nurses is consolidated in the outcomes of the procedure described in the studies, with emphasis on excellent satisfaction among users(28,32), absence of serious complications after the procedure(24,32) and low percentage of effects undesirable(32). It should be noted that there was no significant difference in the outcomes of IUD insertions performed by physicians and nurses(25-27), even when comparing different variables, such as removal, expulsion, retention and unwanted pregnancy(25). The studies defend nurses’ competency to insert IUD and IUS(25-26).
+
+Research on the monitoring of IUD insertions by nurses and physicians at a maternity outpatient clinic showed similar results. Of the total number of IUD inserted, 61.4% were due to procedures performed by nurses; Of these, 69.9% of women did not have any complications recorded at the return visit after 30 days. After 12 months, 90% of women who had IUD inserted by nurses or physicians said they were satisfied with the device. The total continuation of the method was 85.5%, of which 53% were inserted by nurses. There was no significant difference related to complications, when compared with the insertions of physicians and nurses(7).
+
+However, some access barriers to IUD insertion were identified in the present review, such as the physician-centered training model(25,31), lack of training of professionals working in the area of family planning(26) and overload of care services primary care, with a consequent increase in waiting time for care(32). This result is in line with two other studies(1,9) that address the different barriers in access to IUD, namely: non-availability of IUD in PHC or in the municipality itself; lack of protocols for making the method available; pre-established criteria for insertion (such as medical prescription, previous exams, participation in educational groups, prior scheduling); lack of training of professionals and their knowledge of eligibility criteria; limitation of nurses’ role, making the procedure exclusive to physicians; excessive waiting time; and lack of knowledge among the population about the method.
+
+More than half of the studies analyzed addressed access to IUD(15,25-26,30-32), which indicates that this is also a prominent topic regarding device insertion by PHC nurses. Regarding the topic, nurses’ role in IUD insertion showed a greater opportunity for women to learn about LARC methods and access to device insertion. One of the Brazilian experiences reported, carried out in the city of Florianópolis, Santa Catarina, showed a 60% increase in IUD access and provision to adult women and adolescents with device insertion by nurses in PHC(15). Other studies corroborate that IUD insertion by nurses is an important strategy to overcome barriers to accessing health services(33-34).
+
+Regarding access, PHC stands out as an important setting for offering IUD, as it is the gateway to health systems and one of the main reproductive planning services. In this scenario, where human resources are often a problem, especially in medical care, nurse training and performance are fundamental to qualifying contraceptive assistance and guaranteeing sexual and reproductive health care for all women(1,38-39), especially those who live in situations of social vulnerability in the country or anywhere else in the world, preventing, for instance, unwanted pregnancy and abortion, with their complications and/or repercussions.
+
+Study limitations
+
+The limitations of this study are mainly related to the design of most of the studies that made up the sample, characterized as experience reports, which have the lowest level of scientific evidence. Furthermore, the reduced number of studies regarding IUD insertion by nurses in PHC, when compared to other practice scenarios, limited the review sample, including in the national context.
+
+Contributions to nursing, health and public policies
+
+The integrative review made it possible to group different positive experiences regarding IUD insertion by nurses in PHC and, thus, contribute to strengthening this advanced professional practice and stimulating health services to establish a training program for nurses, a strategy that can qualify contraceptive assistance and increase women’s access to IUD, which have been proven to be effective. By shedding light on knowledge production related to the topic, this review also contributes by revealing the need for robust studies with a high level of scientific evidence, such as randomized clinical trials. Furthermore, the review may support legal discussions involving device insertion and removal by nurses, giving visibility to the expansion and strengthening of public policies related to reproductive planning.
+
+CONCLUSIONS
+
+Studies on IUD insertion by nurses in PHC were developed predominantly internationally, the first being published in 1979. The most recent study is Brazilian, the only one developed in the country, published in 2021 and carried out in Florianópolis. Experience report studies prevailed, classified as having a lower level of scientific evidence.
+
+The findings, focusing on PHC, revealed three main themes: Nurse training to insert an intrauterine device; Nurses’ competency to insert an intrauterine device; and Women’s access to intrauterine devices. Different experiences of theoretical and practical training of nurses for IUD insertion were presented, with the participation of different specialties, such as pediatric, family and women’s health nurses. Trained nurses demonstrated competency in this practice, with favorable outcomes, such as the absence of serious complications after the procedure, few undesirable effects and excellent women’s satisfaction with the method. Furthermore, nurses proved to be as competent as physicians in inserting IUD. IUD insertion by nurses proved to be an important strategy to increase women’s access to this device, given the barriers to access to reproductive planning in health services.
+
+Finally, the gaps in scientific knowledge related to IUD insertion by PHC nurses signal the need for robust research on the subject at a national and international level that uses homogeneous methodologies and representative samples, with a high level of scientific evidence, aiming to support and promote this nurses’ professional practice in PHC globally, in addition to strengthening nurses’ advanced practices in the health work process.
+
+
+REFERENCES
+
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+Kemeny F Digiusto E Bateson D. Insertion of intrauterine contraceptive devices by registered nurses in Australia Aust N Z J Obstet Gynaecol 2016 56 1 92 96 10.1111/ajo.12427 26662068
+Thompson CM Broecker J Dade M Nottingham K. Influences on intentions to place long-acting reversible contraceptives: a pilot study comparing according to provider specialty in Ohio J Pediatr Adolesc Gynecol 2018 31 5 509 515 10.1016/j.jpag.2018.03.007 29580916
+Jacobson L Garbers S Helmy H Roobol H Kohn JE Kavanaugh ML. IUD services among primary care practices in New York City Contraception 2016 93 3 257 262 10.1016/j.contraception.2015.11.002 26569447
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+Yadav V Balasubramaniam S Das S Srivastava A Kumar S Sood B. Comparison of outcomes at 6 weeks following postpartum intrauterine contraceptive device insertions by doctors and nurses in India: a case-control study Contraception 2016 93 4 347 355 10.1016/j.contraception.2015.12.012 26738620 PMC4796038
+Lacerda LDRC Arma JC Paes LG Siqueira EF Ferreira LBB Fetzner RRT Inserção de dispositivo intrauterino por enfermeiros da atenção primária à saúde Enferm Foco 2021 12 suppl 1 99 104 10.21675/2357-707X.2021.v12.n7.SUPL.1.5209
+Conselho Federal de Enfermagem (Cofen) Parecer de Câmara Técnica nº 17, de 11 de novembro de 2010 [Internet]. Viabilidade dos enfermeiros realizarem procedimentos com medicamentos e insumos para planejamento familiar reprodutivo 2010 cited 2023 May 25 Available from: http://www.cofen.gov.br/parecer-n-172010-cofen-ctln_6148.html
+Conselho Federal de Enfermagem (Cofen) Resolução nº 690, de 4 de fevereiro de 2022 [Internet]. Normatiza a atuação do enfermeiro no planejamento familiar e reprodutivo Brasília 2022 cited 2023 May 25 Available from: http://www.cofen.gov.br/resolucao-cofen-no-690-2022_96063.html
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+Ouzzani M Hammady H Fedorowicz Z Elmagarmid A. Rayyan: a web and mobile app for systematic reviews Syst Rev 2016 5 210 10.1186/s13643-016-0384-4 27919275 PMC5139140
+Galvão TF Pansani HSA Harrad D. Principais itens para relatar revisões sistemáticas e meta-análises: a recomendação PRISMA Epidemiol Serv Saúde [Internet] 2015 cited 2023 May 25 24 2 335 342 Available from: http://scielo.iec.gov.br/pdf/ess/v24n2/v24n2a17.pdf
+Melnyk BM Gallagher-Ford L Fineout-Overhol E. Implementing the evidence-based practice (EBP) competencies in healthcare: a practical guide to improving quality, safety, and outcomes Indianapolis Sigma Theta Tau International; 2016 194
+Presidência da República (BR) Lei nº 9.610, de 19 de fevereiro de 1998 [Internet]. Altera, atualiza e consolida a legislação sobre direitos autorais e dá outras providências Brasília 1998 cited 2023 May 25 Available from: https://www.planalto.gov.br/ccivil_03/Leis/L9610.htm
+Saniel FL. The Bohol IUD program Stud Fam Plann [Internet] 1979 cited 2023 May 25 10 6-7 211 212 Available from: https://pubmed.ncbi.nlm.nih.gov/483349/ 483349
+Bibb BN. The effectiveness of non-physicians as providers of family planning services J Obstet Gynecol Neonatal Nurs 1979 8 3 137 143 10.1111/j.1552-6909.1979.tb00819.x 110971
+Elton J. Managing change in primary care: part 1 Pract Nurs[Internet] 2008 cited 2023 May 25 36 10 42 44 Available from: https://search.ebscohost.com/login.aspx?direct=true&db=c8h&AN=105616450&lang=pt-br&site=ehost-live
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+Harper CC Stratton L Raine TR Thompson K Henderson JT Blum M Counseling and provision of long-acting reversible contraception in the US: national survey of nurse practitioners Prev Med 2013 57 6 883 888 10.1016/j.ypmed.2013.10.005 24128950 PMC3890255
+Atkin K Beal MW Long-Middleton E Roncari D. Long-acting reversible contraceptives for teenagers: primary care recommendations Nurse Pract 2015 40 3 38 46 10.1097/01.NPR.0000460853.60234.c2 25642635
+Rubin SE Maldonado L Fox K Rosenberg R Wall J Prine L. Establishing and conducting a regional, hands-on long-acting reversible contraception training Center in Primary Care Womens Health Issues 2018 28 5 375 378 10.1016/j.whi.2018.04.010 29891213
+Chin-Quee DS Ridgeway K Onadja Y Guiella G Bai GM Brennan C Evaluation of a pilot program for task sharing short and long-acting contraceptive methods in Burkina Faso Gates Open Res 2020 3 1499 10.12688/gatesopenres.13009.2 PMC7029614 32118198
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+Ouyang M Peng K Botfield JR McGeechan K. Intrauterine contraceptive device training and outcomes for healthcare providers in developed countries: a systematic review PLos ONE 2019 14 7 e0219746 10.1371/journal.pone.0219746 31306443 PMC6629157
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+Lopes RRS Galvão EL Guedes HM. Development and validation of a tool for competence assessment of the insert of the intrauterine device Rev Bras Saúde Mater Infant 2022 22 2 283 295 10.1590/1806-9304202200020006
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+Trigueiro TH Lima GS Borges R Guimarães PRB Souza SRRK Wall ML. Insertion of intrauterine device for doctors and nurses in a low-risk maternity hospital Rev Gaúcha Enferm 2021 42 e20200015 10.1590/1983-1447.2021.20200015 33566948
diff --git a/corpus/healthcare/text/bae1ec6f77a8db91.txt b/corpus/healthcare/text/bae1ec6f77a8db91.txt
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@@ -0,0 +1,373 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Eur Arch Psychiatry Clin Neurosci
+Journal ID: Eur Arch Psychiatry Clin Neurosci
+NLM Journal ID: 9103030
+
+European Archives of Psychiatry and Clinical Neuroscience
+
+ISSN: 0940-1334
+EISSN: 1433-8491
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12904919
+PMID: 40590923
+DOI: 10.1007/s00406-025-02045-5
+Article ID: 2045
+Article version: 1
+Subjects: Original Paper
+
+Enhancing mental health care: a problem, resources and goals oriented multidimensional framework (PRoGO)
+
+http://orcid.org/0000-0002-4934-4352 Leucht Stefan Stefan.Leucht@tum.de
+1 2
+König Bernhard 3
+di Francesco Antonio 1 4
+Rodolico Alessandro 1 4
+Priller Josef 1 2 5 6
+Böge Kerem 7 8 9
+Strube Wolfgang 2 10
+Gensichen Jochen 2 11
+Bechmann Peter 2
+ElDeeb Amr 1 12
+Hasan Alkomiet 2 10
+Moritz Steffen 13
+Jäger Markus 14
+Leucht Claudia 15
+van Os Jim 16 17 18
+Davis John M. 19 20
+1 https://ror.org/02kkvpp62 grid.6936.a 0000000123222966 Department of Psychiatry and Psychotherapy, Klinikum Rechts Der Isar, Technical University of Munich, TUM School of Medicine and Health, Ismaningerstrasse 22, 81675 Munich, Germany
+2 German Center for Mental Health (Partner Site Munich-Augsburg), Munich, Germany
+3 Praxis Deisenhofen, Jägerstr. 16a, 82041 Oberhaching, Germany
+4 https://ror.org/03a64bh57 grid.8158.4 0000 0004 1757 1969 Department of Clinical and Experimental Medicine, Institute of Psychiatry, University of Catania, Catania, Italy
+5 https://ror.org/001w7jn25 grid.6363.0 0000 0001 2218 4662 Neuropsychiatry, Charité—Universitätsmedizin Berlin and Deutsches Zentrum Für Neurodegenerative Störungen, 10117 Berlin, Germany
+6 https://ror.org/01nrxwf90 grid.4305.2 0000 0004 1936 7988 University of Edinburgh and UK DRI, Edinburgh, UK
+7 https://ror.org/001w7jn25 grid.6363.0 0000 0001 2218 4662 Charité Universitätsmedizin Berlin, Berlin, Germany
+8 German Center for Mental Health (Partner Site Berlin), Berlin, Germany
+9 https://ror.org/04839sh14 grid.473452.3 Medizinische Hochschule Brandenburg, Neuruppin, Germany
+10 https://ror.org/03p14d497 grid.7307.3 0000 0001 2108 9006 Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Augsburg, Germany
+11 https://ror.org/05885p792 Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany
+12 https://ror.org/02sk64d67 grid.500083.e KBO-Inn-Salzach Klinikum, Wasserburg Am Inn, Germany
+13 https://ror.org/01zgy1s35 grid.13648.38 0000 0001 2180 3484 Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
+14 District Hospital Kempten, Kempten, Germany
+15 https://ror.org/04dq56617 grid.419548.5 0000 0000 9497 5095 Max Planck Institute of Psychiatry, Munich, Germany
+16 https://ror.org/0575yy874 grid.7692.a 0000000090126352 Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
+17 https://ror.org/0220mzb33 grid.13097.3c 0000 0001 2322 6764 Department of Psychosis Studies‚ Institute of Psychiatry‚ Psychology and Neuroscience‚ King’s College, London, United Kingdom
+18 https://ror.org/0220mzb33 grid.13097.3c 0000 0001 2322 6764 King’s College London, London, UK
+19 https://ror.org/02mpq6x41 grid.185648.6 0000 0001 2175 0319 Psychiatric Institute, University of Illinois at Chicago, Chicago, IL USA
+20 https://ror.org/00za53h95 grid.21107.35 0000 0001 2171 9311 Johns Hopkins University, Baltimore, MD USA
+Electronic publication date: 2025 Jul 1
+Print publication date: 2026
+Volume: 276
+Issue: 1
+First page: 51
+Last page: 61
+Received 2025 Feb 26; Accepted 2025 Jun 9
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Problem-oriented medical records, Transdiagnostic, Lawrence Weed, Psychiatry, Mental health, Schizophrenia, Depression, Anxiety
+
+Funding: German Center for Mental Health FKZ: 01EE2303C Leucht Stefan
+
+Funding: Technische Universität München (1025) Open Access funding enabled and organized by Projekt DEAL.
+
+issue-copyright-statement: © Springer-Verlag GmbH Germany, part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Background
+
+Lawrence Weed introduced the “Problem-Oriented Medical Records” (POMR) approach to medicine. Its core principle is that treatment should be organised around patients’ specific problems. This approach gained widespread adoption in the United States during the 1970s. However, few studies have compared POMR with the traditional “source-based” method, and evidence supporting its application in mental health remains particularly limited.
+
+Methods
+
+We carried out a narrative review to examine whether POMR is appropriate for mental health care and which modifications are necessary for this purpose.
+
+Findings
+
+Psychiatry and psychotherapy address brain-mediated disorders that lack clear biological markers. Diagnoses rely on the assessment of psychopathological symptoms, which are grouped into syndromes. These symptoms and syndromes can be effectively categorized as “problems”. Given that psychiatric treatment is often symptomatic in that it focuses on symptoms rather than diagnoses, POMR provides an ideal framework for organizing care.
+
+Furthermore, mental health is inherently multidimensional, encompassing biological, psychological, social, and existential domains. This complexity necessitates interdisciplinary collaboration. However, under the conventional source-based approach, professional groups often operate in parallel rather than jointly together. POMR, by contrast, facilitates seamless collaboration by aligning teams around patient-centred problems. A special aspect of mental health care is the emphasis on considering patients’ individual goals and resources, rather than focusing only on their deficits.
+
+Interpretation
+
+By systematically applying POMR to psychiatric care—particularly through tightly coordinated interdisciplinary treatment—clinicians could enhance both clinical and functional outcomes, improve both patient and team satisfaction, and better align treatment with patients’ unique needs. To support this approach, we propose a practical grid which we refer to as the Problem–Resources–Goals Oriented framework (PRoGO), reflecting the necessary adaptations for mental health. Clinical trials are warranted to assess the effectiveness of POMR/PRoGO in psychiatric practice and its potential to advance the field.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1007/s00406-025-02045-5.
+
+Introduction
+
+Mental health is a complex field encompassing biology, psychology, sociology and even philosophy. Most psychiatric disorders are currently understood as an interplay of these various dimensions [1, 2]. For instance, the diathesis-stress model suggests that individuals with biological vulnerabilities may develop psychiatric disorders when exposed to stressors such as emotional trauma [3].
+
+Moreover, mental-health problems often manifest as an overlap of various psychopathological dimensions. Examples include schizoaffective disorder, which exists on a continuum between schizophrenia and affective disorders; depression and anxiety, which frequently co-occur; and the phenomenological overlap between bipolar disorder and ADHD.
+
+The diagnostic systems DSM and ICD do not fully capture this dimensionality. They are predominantly categorical, driven in part by administrative and re-imbursement considerations. Moreover, as there are no definitive biomarkers DSM/ICD diagnostic criteria are ultimately determined by consensus. Dimensional diagnostic approaches such as the Hierarchical Taxonomy of Psychopathology (HiTOP) [4], Research Domain Criteria (RDoC), network [5–7] and staging [8] approaches are under development. However, all have limitations so that some have proposed to focus on psychopathological signs and symptoms which are nearer to nature than consensus-based DSM/ICD symptoms [9].
+
+These interplays make mental health more complex than most other medical specialties, where diagnoses and treatment are often more straightforward.
+
+One major practical implication of mental health’s multi-dimensionality is that clinicians must address not only the psychiatric disorder itself but also the broader issues stemming from other dimensions. For instance, unemployment or family problems may contribute to and perpetuate a depressive episode, and addressing these issues is integral to effective treatment.
+
+Traditionally, medical records are organized in a source-oriented manner, grouping information based on its origin, such as laboratory reports, radiology results, or physician and nurse notes. This system emphasizes the source of information rather than the specific problems it addresses. In the 1960 s, Lawrence Weed proposed a shift to a problem-oriented structure, where all relevant data related to a specific patient issue are organized together.
+
+This “problem-oriented medical record” (POMR) system was designed to enhance the clarity and accessibility of patient information, facilitate collaboration among healthcare providers, reduce data duplication, and improve the ability to identify patterns and connections in a patient’s medical history [10]. POMR has been widely adopted in medicine. Curiously, however, despite psychiatric care meaning problem-solving across multiple domains, POMR has not been extensively applied in the psychiatric field.
+
+In this review we work out how integrating problem oriented medical records (POMR) with psychiatry specific elements such as goal- and resource orientation, and a focus on psychopathological phenomena and individual characterization across biological, psychological and social dimensions rather than diagnoses—could enhance psychiatric care. It has the potential to improve treatment efficacy, patient satisfaction, team satisfaction, teaching, and ultimately, patient outcomes. We refer to this approach as the Problem–Resources–Goals Oriented framework (PRoGO), reflecting the necessary adaptations for mental health.
+
+The problem-oriented medical record system (POMR) by Laurence Weed
+
+Laurence Weed argued that the structure of medical data influences how clinicians think and treat patients. He emphasized that the practice of medicine and the organization of medical records are inseparable and inherently intertwined. Moreover, he recognized early on that the human brain cannot retain all the necessary information about each patient, recall all medical knowledge by heart, and integrate both effectively during treatment. To address this limitation, he proposed that medical records should be organised around a patient’s specific problems, and linked to knowledge databases. This approach would ensure that clinicians focus on patients’ needs, enabling more targeted and effective care. The “problem-oriented medical record” (POMR) consists of four key components (see Fig. 1) [11]:1. The database
+
+Fig. 1 Problem-oriented Medical Records (modified for psychiatry from Weed and Weed 2011 [10])
+
+The database encompasses all relevant information about the patient to ensure a comprehensive characterization. During this process, clinicians must systematically gather information by asking targeted questions to document both the presence of symptoms (pertinent positives) and their confirmed absence (pertinent negatives, such as explicitly noting the absence of hallucinations).2. The problem list
+
+This is a hierarchical list of all the patient’s current relevant problems which is reached after a brainstorming phase between team members. It tends to be more comprehensive than a mere list of diagnoses, because only problems that are understood at the level of a diagnosis would make it onto the latter. It provides a clear overview of a patient’s issues at a glance, eliminating the need to shift through the entire chart and ensuring no problems are overlooked. The hierarchical aspect helps prioritizing issues, such as determining which problems can be taken care of during an inpatient stay.3. Treatment plans
+
+For each problem listed, a specific treatment plan is devised.4. Progress notes
+
+They are organised in the SOAP format:Subjective (S): The patient’s report of his condition.
+
+Objective (O): Data from laboratory tests, technical studies, and physical examinations.
+
+Assessment (A): The clinician’s interpretation of the subjective and objective data.
+
+Plan (P): The proposed treatment plan based on the assessment.
+
+The last two components bring a crucial advantage over the source-oriented record. By interpreting subjective and objective data in relation to specific problems, clinicians can clearly plan and articulate the next therapeutic steps.
+
+POMR gained widespread acceptance in the USA during the 1970s. According to a 1972 survey, 82% of all medical schools in the USA taught problem-oriented charting [12, 13]. Weed also developed one of the first electronic health record systems, PROMIS (Problem-Oriented Medical Information System) [14]. However, in 2011, Weed criticized in the article “Medicine in Denial” that the implementation of POMR had stagnated [11]. Today numerous electronic health record systems exist, many of which allow for the creation of problem lists. Nevertheless, the main aim of these systems often leans more toward documentation for financial purposes. The emphasis on problem orientation varies considerably across different electronic health record systems [12].
+
+Scientific evidence for POMR in general
+
+Despite its widespread adoption in practice, few studies have rigorously evaluated the potential benefits of the Problem-Oriented Medical Record (POMR). Chowdry et al. [12] conducted a review of problem-oriented charting by searching PubMed using the term (Medical Records, Problem-Oriented[MeSH Major Topic]) OR problem-oriented charting (877 results as of August 16, 2024). They identified 15 validation studies that examined a range of outcomes across various fields. Some studies reported benefits such as improved documentation, reduced medication cost, enhanced education, increased use of evidence-based treatment, and better management of obesity. However, overall, the results were mixed. In 2011, Weed and Weed [11] reported only two randomized controlled trials comparing the use of information-coupling software to standard care. One trial, focusing on diabetes care, demonstrated substantial benefits [15], while the other, involving a range of diagnoses, showed no significant advantages [16].
+
+Scientific evidence for POMR in psychiatry
+
+A Pubmed search using the terms (“Lawrence Weed” OR “Problem-oriented” OR POMR OR SOAP OR POC) AND (“Mental Health” OR Psych* OR Neuropsychiatry OR Depress* OR Anxiety OR Bipolar OR Schizo* OR “Personality disorder*” OR “Mood Disorder*” OR “Eating Disorder*” OR “Post-traumatic” OR PTSD OR “Obsessive–compulsive” OR OCD OR Addiction* OR Neuroscience OR “Cognitive-Behavioral” OR “Cognitive Behavioral” OR Antidepressant* OR Antipsychotic* OR “Mood Stabilizer*” OR Suicide OR Mindfulness) (last search 26/09/2024) yielded 1805 hits. Of these, 23 articles were deemed relevant.
+
+With one exception—a survey by Bakel et al. 2014 [17]—all reports were old, published between 1973 and 1985. The articles centred around the themes “Presentation of the Problem-Oriented Approach”, “Technical Aspects of the P-O Approach”, “Evaluation of the Effectiveness of the P-O Approach” and “Interventions to Increase the Application of the P-O Approach”. Notably, no controlled trials were identified. Consequently, no clear evidence regarding the effectiveness of POMR can be drawn (see eAppendix 1).
+
+POMR and teaching
+
+Proponents of POMR emphasize its ability to enhance clinical reasoning skills. Every patient encounter becomes an exercise in “problem-based learning,” which is a highly effective educational approach. This method is particularly beneficial for medical students and early-career clinicians. By encouraging structured thinking—identifying problems, formulating treatment plans, and continuously re-evaluating them—POMR fosters critical thinking. Indeed, as illustrated in Fig. 1 through Fig. 4, each issue must be carefully analysed when applying POMR to a patient.
+
+POMR and evidence-based medicine
+
+In his final book, Weed, along with other critics [18], highlighted a limitation of evidence-based medicine (EBM): recommendations for individual patients cannot always be drawn from average results obtained in randomized controlled trials (RCTs) [11]. The issue of generalizability (external validity) of RCT findings, conducted under idealized conditions (internal validity), to routine clinical care is well-recognized. Individualized treatment is also a stated goal of EBM [19]. In practice, deviations from evidence are often necessary. Despite notable exceptions—such as certain areas of cancer treatment—individualized care and precision medicine remain aspirational rather than widespread realities. Thus, for now, there is no viable alternative to integrating EBM within the framework of POMR.
+
+Application of POMR in psychiatry
+
+POMR is particularly well-suited to mental health care, as problem-solving lies at the heart of this specialty more than any other area of medicine. Psychiatry and psychotherapy are inherently multidimensional and these dimensions can be seen as problems which need to be addressed to improve patients’ mental health [9].
+
+First, mental health diagnoses are dimensional, often existing along a continuum between health and severe illness, making it challenging to draw the line. Significant overlap between disorders is common. For instance, depression and anxiety are prevalent across most mental health conditions, and affective disturbances are part of the description of schizophrenia in the ICD-11 [9].
+
+Many psychiatric disorders are likely mediated by alterations in brain networks rather than clearly localizable structural changes, as seen in conditions like stroke or multiple sclerosis. These network alterations could explain why the same individuals may experience schizophrenic, schizoaffective, and depressive episodes throughout their lives, and why bipolar disorder can present with opposing symptoms during depressive and manic episodes.
+
+Psychiatric diagnoses are also “polythetic,” meaning that multiple, sometimes mutually exclusive, constellations of symptoms can lead to the same diagnosis. Currently, there are no biomarkers available for diagnosing psychiatric disorders. In fact, psychiatric conditions are, to some extent, by definition those brain diseases for which visible pathology is absent. Diagnosis ultimately relies on the assessment of psychopathological signs and syndromes.
+
+Moreover, most psychotropic drugs target specific symptoms rather than the consensus-based diagnoses outlined in the DSM or ICD. For instance, antipsychotics primarily target psychotic symptoms, largely independent of the underlying diagnosis, and some also function as mood stabilizers [20]. Antidepressants are effective not only for treating depression but also for managing anxiety, obsessive–compulsive symptoms, and depression associated with schizophrenia [21]. Relying on ICD/DSM diagnosis-based pharmacotherapy can even lead to suboptimal outcomes. Using antipsychotics for patients with schizophrenia who present solely with negative symptoms is ineffective. Dopamine receptor blockade may worsen negative symptoms and cognitive impairments rather than alleviate them [22]. In other words, psychotropic treatment is largely symptom-focused. This symptom-focus also applies to cognitive-behavioural psychotherapy, where interventions such as exposure or cognitive restructuring, are utilized across a range of psychiatric conditions. Therefore, we argue that clinicians should prioritize psychopathological signs in their assessments and treatments. They are closer to nature than consensus-based and thus questionable ICD/DSM criteria [23].
+
+Second, much more than somatic diseases, psychiatric problems are an interplay of multiple dimensions. Psychology evidently plays a major role, with factors such as childhood or recent traumatic events, conditioning, instrumental learning, and coping styles influencing mental health. There is also a significant social dimension in that factors such as poverty, discrimination, loneliness, unemployment, being physically handicapped, marital status, family support and related factors play a role in the development and sustainment of mental problems. In addition to genetic factors, the use of illicit drugs such as cannabis can be considered a contributing biological factor [3]. Moreover, somatic diseases and medication for them can provoke psychiatric symptoms. All of these dimensions represent problems which need to be addressed making POMR a perfect fit for psychiatric care.
+
+Third, the treatment teams are inherently multidimensional. As in other specialties, there are physicians and nurses, but in psychiatry, psychotherapists, (neuro)-psychologists, occupational therapists, physical therapists, peer-support workers and social workers play a major role. Nevertheless, as long as “source-oriented records” are used, these groups sometimes tend to work independently rather than jointly together.
+
+In the following text, we describe how the Problem-Oriented Medical Record (POMR) can be applied to psychiatry and discuss the necessary adaptations, using Weed’s four steps as a framework. Figures 2, 3 and 4 illustrate this approach with an example patient.1. The database
+
+Fig. 2 a I. The Database—Symptoms and Clinical Characterisation. SOFAS Social and Occupational Functioning Assessment Scale [45]. b I. The Database—Resources. *The example patient has good financial resources, # good communication skills and high IQ, SR Social Relationships. The major categories personal resources according to the review by Priebe et al. [42] are presented. As social relationships (SR) were particularly important, we present the major sub-categories according to Priebe et al. [42]
+
+Fig. 3 Goal-adapted prioritized problem list and treatment plans
+
+Fig. 4 Follow-up (SOAP scheme)
+
+In somatic medicine, the database is built using physical examinations, laboratory tests, imaging, and other diagnostic methods. In mental health care, these diagnostics are primarily employed to rule out rare organic causes, serving as crucial “pertinent negatives” that should be documented.
+
+In mental health care, the “database” consists of 1. psychopathological signs, 2. contextual characterization and 3. resources, see Figs. 2a and b.
+
+Psychopathological Signs (Fig. 2a, left): Patients undergo an initial psychopathological assessment using a cross-disorder instrument. The resulting psychopathological signs are visualized in a spider-net plot, enabling the clinician to quickly identify the patient’s key psychopathological issues that require attention. While an ICD or DSM diagnosis is made for purposes such as communication and billing, it is not the central focus of this process.
+
+The currently probably best transdiagnostic rating scale is the Association-for-Methodology-and-Documentation-in-Psychiatry (AMDP) system [24–26]. This scale contains 100 operationalized and manualized mental symptoms, along with 40 somatic symptoms. They are rated following an interview guide as not present, mild, moderate, severe. To address the frequent uncertainty surrounding certain symptoms in clinical practice, we have added the category “questionable/subthreshold”. Additionally, an overall severity rating is recommended using the Adjusted Clinical Global Impression Scale [27] (0–4 rating, where 0 = not present, 1 = questionable, 2 = mild, 3 = moderate, and 4 = severe). The AMDP system is operationalized, well-validated and manualized. It is available in multiple languages [25], maintained by an AMDP society that offers training sessions, and has been in used for over 50 years [26]. Its foundation lies in the psychopathological descriptions of Jaspers [28] and Schneider [29] which were based on clinical observations. However, it may eventually be replaced by a cross-diagnostic instrument developed according to modern standards [30]. For a more detailed description of symptoms, a second-level analysis can be presented (eFigure 1). Once validated, the Transdiagnostic Global Impression Scale may be an option, as well [31].
+
+In the example case, the patient primarily experiences negative symptoms and a cognitive deficit, the latter being a common predictor of poor functioning across many psychiatric disorders [32]. Additionally, the patient suffers from depression and anxiety, as well as some positive symptoms in the form of hallucinations and delusions. The patient also exhibits motor symptoms, which may be attributed to haloperidol medication (Fig. 2a).
+
+It should be noted that if such a spidernet plot were implemented in a smartphone or computer application, different ways of sorting the symptoms could be provided with one click. Moreover, the change of symptoms over time could be displayed.
+
+Further Clinical Characterisation (Fig. 2a, right): The patient is characterized by the following factors, which contribute to the mental disorder and form problems to be addressed. Their selection was guided by publications on depression [33] and primary psychotic disorders [34] (see also [9]):Even in the absence of a diagnosed personality disorder, understanding a patient’s personality style is important. It can guide interactions with the patient and ensure that psychotherapeutic treatments are appropriately tailored to their needs [9].
+
+Intelligence, measured by a brief IQ test such as the Kaufman Brief Intelligence Test [35] or the Wechsler Abbreviated Scale of Intelligence (WASI) [36] can be important in two ways. One is to screen for intellectual disability. We have added this suggestion to Fig. 2a. In contrast, high IQ is a resource which has been shown to be a predictor of good outcome to psychotherapy [37] Therefore, we added high IQ of 120 to Fig. 2b as a personal strength of the theoretical patient.
+
+Physical diseases can either directly impact brain function (e.g. HIV, stroke) or be a psychological burden. Moreover, psychiatrists must take care of relevant comorbid physical illnesses, such as obesity resulting from psychotropic medication.
+
+Understanding a patient’s psychiatric history and staging are essential for prognosis.
+
+Staging (0–4 according to Scott et al. 2024) [38]. The primary goal of staging aims is preventive treatment. We need to intervene as early as possible to avoid chronification. Moreover, treatment should be tailored to the specific stage of the disorder, with earlier stages typically requiring less intensive approaches [39].
+
+While family history is not a modifiable risk factor that can be directly treated, it provides valuable insight into the biological components and potential learning history underlying a mental health issue.
+
+Substance and alcohol use disorders can both cause and perpetuate mental problems. Identifying and addressing such problems is essential for achieving optimal outcomes.
+
+Earlier and recent life events, family or partner conflicts are potential causes of a mental problem which need to be addressed.
+
+The same applies to self-stigma and the stage of personal recovery, where peer-support may be especially valuable [40].
+
+Social problems such as loneliness, unemployment, poverty and discrimination are significant causative factors [41] and must be addressed, often with the help of social workers and peer-support workers. Conversely, the absence of such problems can act as a protective factor and as a resource.
+
+Lack of concordance in medication use is frequent and needs to be recognized, as it cannot be effectively addressed otherwise.
+
+This list contains characteristics that are important for most disorders. Moreover, problem-specific characteristics such as dysfunctional cognitive schema in depression [33], duration of untreated psychosis in first-episode psychosis, which is important for prognosis [34], specific, e.g. genetic, tests for patients with intellectual disability, or speech difficulties in neurodevelopmental disorders can be added.
+
+In the example obesity, elevated liver enzymes and cannabis use must certainly be considered in treatment plans.
+
+Resources (Fig. 2b): Finally, in mental health care it is important to not only focus on deficits, but to also consider the patient’s resources and resilience related factors [42]. To this end, Fig. 2b presents another spiderweb plot outlining the major personal resources as defined by Priebe et al. [42].
+
+The example patient’s resources include strong ties with family and friends, access to professional care, financial means and individual strengths such as good communication skills.2. Goal-adapted, prioritized and hierarchised problem list (Fig. 3, left)
+
+The problems identified in the previous section need to be hierarchised. For example, not all problems can be addressed in an inpatient stay. Incorporating the patient’s goals through a shared-decision-making process [43] is a key addition to Weed’s original proposal. One would also delve into the persons’ values and areas where they find meaning in life. In cases such as pneumonia, curing the illness is naturally aligned with the patient’s goal. In mental health care, the situation can be different. For example, some patients with chronic schizophrenia may not prioritize completely eliminating hallucinations if it involves significant side effects. Instead, they might prefer to reduce symptoms to a level that enables them to engage in social activities. The concept of “personal recovery” is central to this approach. While societal recovery – such as starting a family, gaining a university degree or having a full-time job is often not realistic. If imposed on patients they may overextend themselves and experience frustration. Personal recovery means to re-gain well-being and meaning in life by striving for one’s individual goals [40].
+
+In Figs. 2a and 3, positive symptoms are prioritized, as other symptoms—such as anxiety, depression, negative symptoms, and even cognitive deficits (which may result from formal thought disorder)—are often secondary to positive symptoms and may improve in parallel when the former are resolved. Obesity and elevated liver enzymes represent significant physical health concerns that require immediate attention, particularly in the context of selecting antipsychotic medication. Addressing cannabis use is also critical, as its continued use may hinder improvement in psychotic symptoms. Cognitive training and vocational planning are typically more appropriate toward the end of an inpatient stay.
+
+Figure 3 includes a broad range of psychotherapeutic interventions to emphasize that the treatment of psychosis should not rely solely on antipsychotic medication. Numerous non-pharmacological treatment options are available; however, not all interventions may be accessible or feasible to implement simultaneously. Therefore, when developing a treatment plan, it is advisable to begin by brainstorming potential interventions, which can then be selected and tailored based on the individual needs of the patient.3. Formulating treatment plans (Fig. 3 right)
+
+According to Weed, it is crucial to collaboratively develop a treatment plan for each identified problem. Figure 3 presents treatment plans for the example patient, along with the therapist responsible for each task. Its ability to foster collaborative and interdisciplinary care is a major advantage of POMR. Without jointly formulated treatment plans, team members and the various institutions involved in care may sometimes work independently. This fragmentation partly arises from the structure of source-oriented medical records, where information from each party is stored separately, limiting coordination involving all parties in the planning process could enhance collaboration and improve team satisfaction.
+
+A problem-oriented treatment plan in psychiatry should be co-created with the patients, enabling them to actively participate in their care. Central to this approach is respecting the patient’s voice and preferences, supporting their autonomy while addressing the biological, psychological, social, and existential dimensions of their struggles. Mental suffering is a complex, multi-dimensional phenomenon, and this requires adopting a pluralistic approach that acknowledges the various perspectives through which mental health and illness can be understood. A comprehensive treatment plan should not only focus on symptom reduction but also promote personal recovery by helping individuals find meaning and value in their lives, even in the presence of ongoing symptoms or disabilities. The plan should aim to support the development of resilience and coping skills, tailored to the individual’s strengths and life context. This includes fostering social skills, emotional regulation, and self-management strategies, empowering the patient to navigate challenges and setbacks in a way that aligns with their values and fosters personal growth.
+
+The treatment plan should be integrated within a “mental health ecosystem” [44] which refers to a network of collaborative partners in primary care, mental health, social care, recovery colleges, informal support, complementary care, and digital communities. This ecosystem approach provides a comprehensive context for addressing problems that go beyond the traditional medical model. Patients are encouraged to actively engage in their recovery process by navigating this ecosystem, giving them the opportunity to explore various treatment modalities that align with their needs, preferences, and personal recovery goals. The plan would offer flexibility, allowing the patient to choose where to begin within the ecosystem—be it through psychotherapy, social support, recovery academies, or even online self-help communities.
+
+Integrating these biopsychosocio-existential and ecosystem principles can transform the problem-oriented treatment plan in psychiatry into a dynamic, patient-centred process. This approach shifts the focus from merely symptom reduction to also fostering a life of meaning and well-being, recognizing each individual’s unique journey within the broader social and existential context.4. Progress notes (Fig. 4)
+
+The final step of POMR, progress notes should follow Weed’s general approach, with one exception: the “objective (O)” component in the SOAP format is by nature less the focus in mental health care. However, standardized and validated methods to access psychopathology, resources and deficits form the “O” in the psychiatric setting within the SOAP scheme.
+
+In some countries, paper health records are still in use, but in the medium-term, electronic health record systems will become the standard. These electronic systems must be designed in a way that fully supports the implementation of the problem-based approach.5. Knowledge Tools (Fig. 1, middle)
+
+Finally, it is important to note that Weed advocated for computerized tools. Patient characteristics should be linked to a knowledge database, and potential diagnoses should be identified using computer software. He rightly argued that clinicians cannot know all medical knowledge, process it and apply it to individual patients. As a result, clinicians often rely on a mixture of knowledge, experience, “clinical wisdom”, “intuition” and “guesswork” [11]. This insight remains crucial and computer-assisted medicine represents the future. In mental health care, this is less straightforward as diagnoses are primarily based on psychopathological signs rather than biological tests. Nevertheless, Figs. 2 and 3 already represent a basic electronic tool, and treatment guidelines could be implemented in electronic health records. Such integration would encourage more frequent use of these guidelines, improving decision-making in clinical practice.
+
+Conclusion
+
+Psychiatric problems are syndromes, not distinct diagnostic entities with clear biological pathologies. They are multi-dimensional, encompassing biological, psychological, and social aspects. This complexity makes them particularly suited for a problem-oriented approach, which emphasizes symptoms and contextual characterization, coupled with goal-setting and resource-oriented strategies, rather than solely relying on ICD/DSM diagnoses. This approach systematically and holistically embraces patients, emphasizing patient related goals and personal recovery over societal expectations. We refer to this approach as the Problem–Resources–Goals Oriented framework (PRoGO), reflecting the necessary adaptations for mental health care. The aim is that such an approach will enhance treatment outcomes, as well as patient and team satisfaction. Trials to assess its feasibility, effectiveness, and utility in psychiatry are warranted. Before these can be conducted, many issues such as how POMR/PRoGO can be integrated into the current health record systems, and how it can be fitted into the clinical workflows need to be considered and piloted.
+
+Supplementary Information
+
+Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 49 KB)
+
+Acknowledgements
+
+Stefan Leucht, Alkomiet Hasan, Josef Priller, Wolfgang Strube, and Peter Bechmann are supported by the clinical trials infrastructure and the antistigma activities of the DZPG [German Center for Mental Health] [FKZ: 01EE2303C].
+
+Funding
+
+Open Access funding enabled and organized by Projekt DEAL. German Center for Mental Health, FKZ: 01EE2303C, Stefan Leucht, Alkomiet Hasan, Josef Priller, Wolfgang Strube and Peter Bechmann
+
+Declarations
+
+Conflict of interest
+
+In the last three years Stefan Leucht has received honoraria for advising/consulting and/or for lectures and/or for educational material from Angelini, Apsen, Boehringer Ingelheim, Janssen, Karuna, Kynexis, Lundbeck, Medscape, Otsuka, Neurotorium, NovoNordisk, Orionpharma, Otsuka, Roche, Rovi, TEVA. Alkomiet Hasan was or is a member of advisory boards and received paid speakership by Boehringer-Ingelheim, Lundbeck, Otsuka, Rovi, Teva (no speakership), AbbVie, Recordati and Advanz. He is editor of the AWMF German guidelines for schizophrenia. Wolfgang Strube has received a paid speakership from Mag & More (neurocare), Recordati and Rovi. He was member of advisory boards of Recordati, Janssen and Boehringer Ingelheim. Invitations to conferences or other activities were not accepted. Steffen Moritz: SM received honoraria as a consultant in advisory boards
+
+Jim van Os and John M. Davis have contributed equally to this work.
+
+
+References
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+Helfer B, Samara MT, Huhn M, Klupp E, Leucht C, Zhu Y, Engel RR, Leucht S (2016) Efficacy and safety of antidepressants added to antipsychotics for schizophrenia: a systematic review and meta-analysis. Am J Psychiatry 173:876–88627282362 10.1176/appi.ajp.2016.15081035
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+Krause M, Zhu Y, Huhn M, Schneider-Thoma J, Bighelli I, Nikolakopoulou A, Leucht S (2018) Antipsychotic drugs for patients with schizophrenia and predominant or prominent negative symptoms: a systematic review and meta-analysis. Eur Arch Psychiatr Clin Neurosci 268:625–63910.1007/s00406-018-0869-3 29368205
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+Leucht S, Siafis S, Schneider-Thoma J, Tajika A, Priller J, Davis JM, Furukawa TA (2024) Are the results of open randomised controlled trials comparing antipsychotic drugs in schizophrenia biased? Exploratory Meta Subgroup Anal Schizophr (Heidelb) 10:1710.1038/s41537-024-00442-8 PMC10866997 38355616
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+Stieglitz RD, Haug A, Fahndrich E, Rosler M, Trabert W (2017) Comprehensive psychopathological assessment based on the association for methodology and documentation in psychiatry (amdp) system: Development, methodological foundation, application in clinical routine, and research. Front Psychiatr/Front Research Found 8:4510.3389/fpsyt.2017.00045 PMC5383714 28439242
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+Baumann U, Stieglitz RD (1989) evaluation of the system of the study group of methodology and documentation in psychiatry based on recent literature (1983 to 1987)–a review. Fortschr Neurol Psychiatr 57:357–3732676809 10.1055/s-2007-1001132
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+Correll CU, Dombi ZB, Barabassy A, Nemeth G, Brevig T, McIntyre RS (2024) The transdiagnostic global impression - psychopathology scale (tgi-p): Initial development of a novel transdiagnostic tool for assessing, tracking, and visualising psychiatric symptom severity in everyday practice. Eur Neuropsychopharmacol: J Eur Coll Neuropsychopharmacol 88:31–3910.1016/j.euroneuro.2024.07.012 39121713
+32. Millan MJ Agid Y Brune M Bullmore ET Carter CS Clayton NS Connor R Davis S Deakin B DeRubeis RJ Dubois B Geyer MA Goodwin GM Gorwood P Jay TM Joels M Mansuy IM Meyer-Lindenberg A Murphy D Rolls E Saletu B Spedding M Sweeney J Whittington M Young LJ Cognitive dysfunction in psychiatric disorders: characteristics, causes and the quest for improved therapy Nat Rev Drug Discov 2012 11 141 168 10.1038/nrd3628 22293568
+Millan MJ, Agid Y, Brune M, Bullmore ET, Carter CS, Clayton NS, Connor R, Davis S, Deakin B, DeRubeis RJ, Dubois B, Geyer MA, Goodwin GM, Gorwood P, Jay TM, Joels M, Mansuy IM, Meyer-Lindenberg A, Murphy D, Rolls E, Saletu B, Spedding M, Sweeney J, Whittington M, Young LJ (2012) Cognitive dysfunction in psychiatric disorders: characteristics, causes and the quest for improved therapy. Nat Rev Drug Discov 11:141–16822293568 10.1038/nrd3628
+33. Maj M Stein DJ Parker G Zimmerman M Fava GA De Hert M Demyttenaere K McIntyre RS Widiger T Wittchen HU The clinical characterization of the adult patient with depression aimed at personalization of management World Psychiatr: Offl J World Psychiatr Assoc 2020 19 269 293 10.1002/wps.20771 PMC7491646 32931110
+Maj M, Stein DJ, Parker G, Zimmerman M, Fava GA, De Hert M, Demyttenaere K, McIntyre RS, Widiger T, Wittchen HU (2020) The clinical characterization of the adult patient with depression aimed at personalization of management. World Psychiatr: Offl J World Psychiatr Assoc 19:269–29310.1002/wps.20771 PMC7491646 32931110
+34. Maj M van Os J De Hert M Gaebel W Galderisi S Green MF Guloksuz S Harvey PD Jones PB Malaspina D McGorry P Miettunen J Murray RM Nuechterlein KH Peralta V Thornicroft G van Winkel R Ventura J The clinical characterization of the patient with primary psychosis aimed at personalization of management World Psychiatry 2021 20 4 33 10.1002/wps.20809 33432763 PMC7801854
+Maj M, van Os J, De Hert M, Gaebel W, Galderisi S, Green MF, Guloksuz S, Harvey PD, Jones PB, Malaspina D, McGorry P, Miettunen J, Murray RM, Nuechterlein KH, Peralta V, Thornicroft G, van Winkel R, Ventura J (2021) The clinical characterization of the patient with primary psychosis aimed at personalization of management. World Psychiatry 20:4–3333432763 10.1002/wps.20809 PMC7801854
+35. Kaufman AS Kaufman NL Kaufman brief intelligence test 2004 Circle Pines, MN Springer
+Kaufman AS, Kaufman NL (2004) Kaufman brief intelligence test. Springer, Circle Pines, MN
+36. Wechsler D Wechsler abbreviated scale of intelligence (wasi-ii) 2011 San Antonio Pearson
+Wechsler D (2011) Wechsler abbreviated scale of intelligence (wasi-ii). Pearson, San Antonio
+37. Knekt P Saari T Lindfors O Intelligence as a predictor of outcome in short- and long-term psychotherapy Psychiatry Res 2014 220 1019 1027 10.1016/j.psychres.2014.10.011 25454120
+Knekt P, Saari T, Lindfors O (2014) Intelligence as a predictor of outcome in short- and long-term psychotherapy. Psychiatry Res 220:1019–102725454120 10.1016/j.psychres.2014.10.011
+38. Scott J Iorfino F Capon W Crouse J Nelson B Chanen AM Dwyer D Conus P Bechdolf A Ratheesh A Raballo A Yung A Berk M McKenna S Hockey S Hutcheon A Scott E McGorry P Shah J Hickie IB Staging 2.0: Refining transdiagnostic clinical staging frameworks to enhance reliability and utility for youth mental health Lancet Psychiatr 2024 11 461 471 10.1016/S2215-0366(24)00060-9 38643773
+Scott J, Iorfino F, Capon W, Crouse J, Nelson B, Chanen AM, Dwyer D, Conus P, Bechdolf A, Ratheesh A, Raballo A, Yung A, Berk M, McKenna S, Hockey S, Hutcheon A, Scott E, McGorry P, Shah J, Hickie IB (2024) Staging 2.0: Refining transdiagnostic clinical staging frameworks to enhance reliability and utility for youth mental health. Lancet Psychiatr 11:461–47110.1016/S2215-0366(24)00060-9 38643773
+39. McGorry PD Hickie IB Clinical staging in psychiatry: making diagnosis work for research and treatment 2019 Cambridge Cambridge University Press
+McGorry PD, Hickie IB (2019) Clinical staging in psychiatry: making diagnosis work for research and treatment. Cambridge University Press, Cambridge
+40. van Weeghel J van Zelst C Boertien D Hasson-Ohayon I Conceptualizations, assessments, and implications of personal recovery in mental illness: a scoping review of systematic reviews and meta-analyses Psychiatr Rehabil J 2019 42 169 181 10.1037/prj0000356 30843721
+van Weeghel J, van Zelst C, Boertien D, Hasson-Ohayon I (2019) Conceptualizations, assessments, and implications of personal recovery in mental illness: a scoping review of systematic reviews and meta-analyses. Psychiatr Rehabil J 42:169–18130843721 10.1037/prj0000356
+41. Foundation WHOaCG Social determinants of mental health 2014 Geneva World Health Organisation
+Foundation WHOaCG (2014) Social determinants of mental health. World Health Organisation, Geneva
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+Priebe S, Omer S, Giacco D, Slade M (2014) Resource-oriented therapeutic models in psychiatry: conceptual review. Br J Psychiatry 204:256–26124692752 10.1192/bjp.bp.113.135038
+43. Hamann J Leucht S Kissling W Shared decision making in psychiatry Acta Psychiatr Scand 2003 107 403 409 10.1034/j.1600-0447.2003.00130.x 12752015
+Hamann J, Leucht S, Kissling W (2003) Shared decision making in psychiatry. Acta Psychiatr Scand 107:403–40912752015 10.1034/j.1600-0447.2003.00130.x
+44. van Os J Scheepers F Milo M Ockeloen G Guloksuz S Delespaul P “It has to be better, it can be better, otherwise we will get stuck”. The gem social trial for mental health reform in The Netherlands Clin Pract Epidemiol Ment Health 2023 19 e17450179271206 10.2174/0117450179271206231114064736 38680529 PMC11046893
+van Os J, Scheepers F, Milo M, Ockeloen G, Guloksuz S, Delespaul P (2023) “It has to be better, it can be better, otherwise we will get stuck”. The gem social trial for mental health reform in The Netherlands. Clin Pract Epidemiol Ment Health 19:e1745017927120638680529 10.2174/0117450179271206231114064736 PMC11046893
+45. Morosini PL Magliano L Brambilla L Ugolini S Pioli R Development, reliability and acceptability of a new version of the dsm-iv social and occupational functioning assessment scale (sofas) to assess routine social functioning Acta PsychiatrScand 2000 101 323 329 10782554
+Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R (2000) Development, reliability and acceptability of a new version of the dsm-iv social and occupational functioning assessment scale (sofas) to assess routine social functioning. Acta PsychiatrScand 101:323–32910782554
+46. American Psychiatric Association Diagnostic and statistical manual of mental disorders 2013 5 Arlington, VA American Psychiatric Publishing
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+Fazel S et al (2013) Schizophrenia and intellectual disability: a review of the literature. Schizophr Res 145(1–3):15–23
+48. Atilola O The diagnostic conundrum of schizophrenia and intellectual disability Psychiatry Res 2013 207 1–2 49 56
+Atilola O (2013) The diagnostic conundrum of schizophrenia and intellectual disability. Psychiatry Res 207(1–2):49–56
+49. McGrew JH Schizophrenia and intellectual disabilities: a review of current clinical approaches J Dev Disabil 2014 39 2 124 132
+McGrew JH et al (2014) Schizophrenia and intellectual disabilities: a review of current clinical approaches. J Dev Disabil 39(2):124–132
diff --git a/corpus/healthcare/text/bbba6fa18d81fd4f.txt b/corpus/healthcare/text/bbba6fa18d81fd4f.txt
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: EMBO J
+Journal ID: EMBO J
+NLM Journal ID: 8208664
+
+The EMBO Journal
+
+ISSN: 0261-4189
+EISSN: 1460-2075
+Publisher: Nature Publishing Group
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13144674
+PMID: 41876742
+DOI: 10.1038/s44318-026-00758-4
+Article ID: 758
+Article version: 1
+Subjects: Author Correction
+
+Author Correction: Residual apoptotic activity of a tumorigenic p53 mutant improves cancer therapy responses
+
+Timofeev Oleg 1
+Klimovich Boris 1
+Schneikert Jean 1
+Wanzel Michael 1 2
+Pavlakis Evangelos 1
+Noll Julia 1
+Mutlu Samet 1
+Elmshäuser Sabrina 1
+Nist Andrea 3
+Mernberger Marco 1
+Lamp Boris 3
+Wenig Ulrich 4
+Brobeil Alexander 4
+Gattenlöhner Stefan 4
+Köhler Kernt 5
+http://orcid.org/0000-0003-0134-7826 Stiewe Thorsten thorsten.stiewe@uni-marburg.de
+1 2 3
+1 https://ror.org/01rdrb571 grid.10253.35 0000 0004 1936 9756 Institute of Molecular Oncology, Philipps-University, Marburg, Germany
+2 https://ror.org/03dx11k66 grid.452624.3 Universities of Giessen and Marburg Lung Center, German Center for Lung Research (DZL), Marburg, Germany
+3 https://ror.org/01rdrb571 grid.10253.35 0000 0004 1936 9756 Genomics Core Facility, Philipps University, Marburg, Germany
+4 https://ror.org/033eqas34 grid.8664.c 0000 0001 2165 8627 Institute of Pathology, Justus Liebig University, Giessen, Germany
+5 https://ror.org/033eqas34 grid.8664.c 0000 0001 2165 8627 Institute of Veterinary Pathology, Justus Liebig University, Giessen, Germany
+Electronic publication date: 2026 Mar 24
+Publication date: 2026 May
+Volume: 45
+Issue: 9
+First page: 3332
+Last page: 3335
+Received 2026 Feb 19
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Residual apoptotic activity of a tumorigenic p53 mutant improves cancer therapy responses 38 20 4 9 2019 e102096 The EMBO Journal 10.15252/embj.2019102096 PMC6792016 31483066
+issue-copyright-statement: © European Molecular Biology Organization 2026
+
+Ÿ==============================Ÿ
+
+
+Correction to: The EMBO Journal (2019) 38:e102096. 10.15252/embj.2019102096 | Published online 4 September 2019
+
+The authors contacted the journal after being made aware of a possible reuse within Figure 7G. The authors supplied the journal with direct exports of the unmodified raw data. The journal verified the raw data and agrees to retract and replace Figure 7G.
+
+Figure 7G is corrected.
+
+Author statement: We were made aware of a reuse of image in the untreated Trp53+/+ cohort at Day 0. This duplication resulted from a copy–paste error during figure assembly. We have carefully re-examined the original source data and confirmed that this error is confined to this panel and does not affect any other figures presented in the manuscript.
+
+We have provided a corrected version of Figure 7G.Figure 7 Original.
+
+Figure 7 Corrected. Source data are available online for this figure.
+
+All authors agree to this correction and apologise for any inconvenience caused.
+
+Supplementary information
+
+Figure 7G Source Data
+
+Supplementary information
+
+Expanded view data, supplementary information, appendices are available for this paper at 10.1038/s44318-026-00758-4.
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Rev Med Virol
+Journal ID: Rev Med Virol
+NLM Journal ID: 9112448
+Journal ID: RMV
+
+Reviews in Medical Virology
+
+ISSN: 1052-9276
+EISSN: 1099-1654
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12905817
+PMID: 41689447
+DOI: 10.1002/rmv.70115
+Article ID: RMV70115
+Article version: 1
+Subjects: Review, Review
+
+High‐Risk HPV in Men: A Hidden Threat to Public Health?
+
+Coker Keesha L. 1
+Morgan Ethan L. https://orcid.org/0000-0002-6487-5450 1 2 e.l.morgan@sussex.ac.uk ethanm@cing.ac.cy
+
+1 School of Life Sciences University of Sussex Brighton UK
+2 Tumour Virology Group The Cyprus Institute of Neurology and Genetics Nicosia Cyprus
+* Correspondence: Ethan L. Morgan
+(e.l.morgan@sussex.ac.uk;
+ethanm@cing.ac.cy)
+
+Electronic publication date: 2026 Feb 14
+Print publication date: 2026 Mar
+Volume: 36
+Issue: 2
+Electronic Location ID: e70115
+Revised 2026 Jan 13; Received 2025 Sep 26; Accepted 2026 Jan 28
+Copyright: © 2026 The Author(s). Reviews in Medical Virology published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: HPV, public health, vaccination
+Figure count: 2
+Table count: 0
+Page count: 10
+
+source-schema-version-number: 2.0
+cover-date: March 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.6.8 mode:remove_FC converted:14.02.2026
+
+Coker, Keesha L. , and Ethan L. Morgan . 2026. “High‐Risk HPV in Men: A Hidden Threat to Public Health?” Reviews in Medical Virology: e70115. 10.1002/rmv.70115.
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+High‐risk human papillomavirus (HR‐HPV) infection is a leading cause of several cancers, including those of the genital and oropharyngeal regions. While public health efforts have largely focused on women due to its link to cervical cancer, HPV also poses significant risks to men, particularly in the oropharyngeal regions. HR‐HPV prevalence in men is high, with global estimates of 21% for male genital infections. While the HPV vaccination programme has expanded to include boys, challenges remain, including a decline in vaccine uptake due to COVID‐19 disruptions, vaccine hesitancy, and misinformation. These barriers hinder the full potential of vaccination efforts. Furthermore, HPV transmission is complex and multifactorial, making it difficult to track, while its prevalence, clearance, and persistence vary based on factors such as sexual behaviour and immune status. Additionally, data from lower socio‐economic regions is limited, highlighting a critical gap in research. Specific data on these epidemiological characteristics for male patients is lacking, prompting the need for gender‐balanced approaches. Here, we explore the prevalence, risks, and public health implications of high‐risk HPV (HR‐HPV) in men. We suggest a more inclusive approach to HPV prevention, emphasising the need for targeted vaccination and screening programs for men. A gender‐neutral approach is crucial to reducing the global burden of HPV‐related diseases and moving closer to the goal of eradicating HPV infections worldwide.
+
+Abbreviations
+
+ASIR Age‐Standardised Incidence Rate
+
+ASMR Age‐Specific Mortality Rate
+
+HIV Human immunodeficiency virus
+
+HNSCC Head and neck squamous cell carcinoma
+
+HPV Human papillomavirus
+
+HR High risk
+
+MSM Men who have sex with men
+
+STI Sexually transmitted infection
+
+1 Introduction
+
+Human papillomavirus (HPV) is one of the most prevalent sexually transmitted infections worldwide, with over 80% of sexually active individuals projected to contract the virus at least once in their life [1]. Of the 400 identified HPV types, high‐risk HPV (HR‐HPV) types, such as HPV16 and HPV18, are responsible for nearly 5% of all cancers globally, including cervical cancer, oropharyngeal cancer and several anogenital cancers (vaginal, vulvar, penile and anal cancer) [2]. While the association between HPV and cervical cancer in women is well established, its impact on men's health has garnered increasing attention in recent years. In particular, the rising incidence of oropharyngeal cancers ‐ now the most common HPV‐related cancers in some regions [3] ‐ underscores the critical need to address HPV as a shared public health concern. Despite this, the impact of HR‐HPV on male populations remains poorly understood, revealing significant gaps in research and prevention efforts.
+
+Public health initiatives have historically focused on HPV in women due to the high burden of cervical cancer and the availability of screening and vaccination programs [4]. These efforts have markedly reduced cervical cancer rates, particularly in high‐income countries. However, this female‐centric approach has overlooked the risks HPV poses to men. Current research has primarily examined high‐risk male populations, such as men who have sex with men (MSM) and immunocompromised individuals, leaving the general male population inadequately represented. As a result, men not only face heightened risks of HPV‐related cancers but also contribute to the continued transmission of the virus, exacerbating its public health impact.
+
+The lack of gender‐neutral strategies, including inclusive vaccination campaigns and screening protocols for men, compounds this issue. Although the HPV vaccine is highly effective in preventing infection and related cancers, its uptake remains inconsistent across male populations and underserved regions, often hindered by limited awareness and access [5]. The COVID‐19 pandemic has further disrupted vaccination programs, reducing coverage for both sexes and fuelling vaccine hesitancy [6]. Additionally, the absence of standardised HPV screening for men prevents early detection of infections or precancerous conditions, leaving many unaware of their risks [7]. This inequity in public health policy not only neglects men's health but also undermines the broader goal of eradicating HPV and its associated diseases by perpetuating the circulation of infection.
+
+Here, we seek to address critical gaps in the understanding of HR‐HPV in men by highlighting its prevalence, epidemiology, and associated health risks. By challenging the perception of HPV as a women's health issue, we advocate for gender‐neutral vaccination and screening protocols, aiming to enhance global prevention strategies and public health outcomes. Ultimately, we aim to provide actionable recommendations for equitable and inclusive HPV prevention efforts worldwide.
+
+2 Methods
+
+A systematic literature search was performed to identify studies examining the prevalence of HPV in men, its association with high‐risk HPV types and related cancers in men, as well as evaluate vaccinology and current HPV related public health programs in men. The search was conducted using the PubMed database, focussing on publications from 2010 onwards. The search strategy was based on predefined keywords and MeSH terms relevant to the research question. Key search terms included: ‘High‐risk HPV in men’, ‘HPV‐associated cancers in men’, ‘oropharyngeal cancer’, ‘HPV epidemiology in men’, ‘HPV vaccination in men’ and ‘HPV in men versus women’. Boolean operators (AND, OR and NOT) were used to refine and combine search terms yielding as many relevant studies as possible.
+
+The search was restricted to articles published in English, focussing on human studies involving male populations. Studies were included if they assessed high‐risk HPV types in men and investigated HPV‐related cancers. Comparisons to male figures were made where relevant using studies focused on women. Studies were excluded if they involved animal or in vitro research or primarily examined low‐risk HPV types.
+
+3 HPV Infection and Transmission
+
+The primary drivers of HR‐HPV induced oncogenesis are the viral oncogenes E6 and E7, which manipulate host cell signalling pathways to promote proliferation and survival [8, 9]. Furthermore, HR‐HPV genomes can also integrate into the host genome, resulting in uncontrolled expression of E6 and E7 and driving oncogenesis [10, 11]. While most HPV infections are transient and resolve spontaneously within 1–2 years after exposure [12], persistent infection with HR‐HPV is a critical factor in the development of pre‐cancerous lesions that can progress to cancer [13].
+
+HPV is primarily transmitted through direct skin‐to‐skin contact during sexual activities although its ease and diversity of transmission is evidenced by its spread through non‐penetrative sexual contact, such as genital‐to‐genital contact as depicted in Figure 1 [14, 15]. An important but often overlooked route of transmission is oro‐genital contact, where the virus is transferred from the genital area to the oropharynx. This pathway has gained attention due to the rising rates of oropharyngeal cancers linked to HPV [16, 17] particularly among men, where in some regions, oropharyngeal cancers now surpass cervical cancer in annual incidence [18].
+
+FIGURE 1 Primary transmission routes of HPV. Illustration of the primary transmission routes of human papillomavirus (HPV), depicting the sources of infection and providing relevant details on the frequency of transmission. Adapted from [31].
+
+HPVs adaptability is further seen through autoinoculation between anatomical sites, though this remains debated [19]. Additionally, studies show inter‐site transmission between partners, with identical HPV types detected across multiple sites, demonstrating seamless spread between site and partners [20].
+
+Other research has identified factors influencing HPV transmission and persistence, including number of sexual partners [21], HIV status [22], circumcision status [23, 24], partner HPV status, and condom use [25]. Transmission is expectedly higher with HPV‐positive partners [26]. Such variability highlights the complex interplay of host and environmental factors shaping HPV epidemiology. HPV's high transmissibility presents major challenges for kerbing its spread. Contemporary sexual behaviours, such as casual partnerships driven by dating apps [27, 28] and the growing prevalence of oral sex may be the cause of amplified transmission and contribution to rising HPV‐related oropharyngeal cancers, particularly in men [29, 30]. Inconsistent condom use paired with limited awareness of risks beyond cervical cancer further facilitate spread across populations, underscoring the need to address this as a universal public health concern requiring strategies that account for its unpredictable nature.
+
+4 HPV Clearance
+
+HPV infection exhibits a dynamic natural history, with most infections clearing spontaneously but some persisting long‐term, depending on a combination of viral, host, and environmental factors. HPV clearance rates are influenced by factors such as age, immune competence, and co‐factors like smoking or coinfections [32, 33], as well as demographic, biological, and anatomical factors [34]. While persistence increases disease risk, timely clearance mitigates long‐term outcomes, including HPV‐related cancer development. The HPV Infection in Men (HIM) Study, a multinational cohort of 4085 HIV‐negative men aged 17–80, examined HPV incidence and clearance. The study found variations across genotypes, with a median clearance time of 7.52 months (95% confidence interval (CI) 6.80–8.61) for any HPV and 12.19 months (95% CI 7.16–18.17) for HPV16, reflecting its immune evasion and oncogenic potential [35, 36]. These findings emphasise the need to monitor high‐risk types, particularly in male populations, due to their role in cancers of the penis, anus, and oropharynx.
+
+HPV clearance rates differ between sex, HPV type, site of infection and study. Genital HPV infection in men had a median clearance time of 5.9 months, with 75% resolving within 12 months [35]. In women, where high‐risk types like HPV16 can persist longer, there was a median clearance time of 11 months [37]. At non‐genital sites, such as the oropharynx, men show higher persistent HPV infections, where prevalence is nearly three times higher in men (10.1%) than in women (3.6%), posing significant challenges due to their association with oropharyngeal cancers [38]. Age impacts HPV clearance differently in men and women. Research suggests older men may clear genital HPV infections faster, potentially due to reduced exposure to new infections and immune adaptations [39]. Conversely, older women, especially post‐menopause, experience reactivation of HPV infections and seemingly slower clearance [40].
+
+Geographical and socioeconomic disparities significantly influence HPV clearance. High‐income regions often report shorter clearance durations due to earlier detection, better healthcare follow‐up, and broader vaccination coverage. In contrast, individuals in low‐ and middle‐income countries may experience delayed diagnosis and limited access to screening or treatment, contributing to persistence and higher progression risk. These can also manifest as intra‐regional sex disparities, where women may access routine reproductive health services that improve early detection, while men often face stigma or limited awareness of HPV risk, leading to not only undiagnosed or persistent infections but imbalanced healthcare outcomes. Once again factors such as circumcision prevalence, hygiene practices, smoking, and coinfections (e.g., HIV or other STIs) further shape clearance patterns across populations. However, this variability in clearance and persistence remains an under‐researched area of HPV natural history. The HIM Study's robust design and multinational scope have helped establish reference points for HPV clearance timelines and clarified sex‐specific patterns. However, a more globally inclusive approach is needed to account for underrepresented populations and variable regional contexts. Whilst the implementation of screening programs in men will aid in this endevour, detailed tracking of HPV persistence in infected individuals at the molecular level are also required.
+
+5 Prevalence of HR‐HPV in Males
+
+The epidemiology of HR‐HPV in males has been significantly under‐researched compared to women, with most prior research limited to high‐risk groups such as men who have MSM and individuals with HIV. This narrow focus has hindered the development of comprehensive prevention strategies targeting the general male population.
+
+To address this gap, Bruni et al. (2023) [41] conducted a systematic review estimating male genital HPV prevalence, including over 44,000 men from 65 studies across 35 countries, one of the most comprehensive analyses to date. Nonetheless, it remains modest in scale compared with Bruni et al.’s 2010 study [42] in women, which evaluated HPV prevalence in more than one million participants. Bruni et al.’s 2023 study samples a diverse range of cohorts including university students, military personnel, and asymptomatic men while excluding high‐risk groups to establish a critical baseline for assessing the impact of gender‐neutral vaccination programs in the future. Findings showed a global HPV prevalence of 31% in men, with HR‐HPV at 21%. HPV16 emerged as the most common type in four of the five global regions analysed, as depicted in Figure 2, with a global prevalence of 5%, solidifying its major public health impact in both sexes [43].
+
+FIGURE 2 Global Percentage Distribution of Genital HPV Prevalence in Men. The map highlights the regional prevalence of any HPV type, with additional data illustrating the percentage distribution of HR‐HPV types and specific HPV types 16 and 6. Created based on data from [41].
+
+HPV infection is widespread across the male lifespan, with prevalence peaking among individuals aged 25–29, particularly for HPV16. Elevated rates were also observed in males aged 15–19, a finding consistent with transmission shortly after sexual debut, a pattern similarly seen in females [44]. Regionally, aggregated data reinforced this global trend, with a consistent peak in HPV prevalence across all categories between the ages of 20 and 29. Sub‐Saharan Africa and Northern America reported the highest prevalence rates, particularly among men aged 25–29, while Eastern and South‐Eastern Asia exhibited substantially lower rates. These regional differences may reflect variations in sexual behaviours, cultural practices, healthcare access, and HPV vaccination uptake much like those to do with clearance.
+
+In most regions HPV prevalence showed a gradual decline after the late twenties, however Europe and Latin America and the Caribbean exhibited a secondary rise among men aged ≥ 50, a bimodal pattern also seen in female populations [45], and may reflect biological and behavioural shifts with age, including immunosenescence and changes in sexual activity. In North America, prevalence remained elevated extended into ages 30–39, particularly for any HPV type and HR‐HPV. Methodological differences also influenced estimates, with studies sampling multiple genital sites (e.g., glans, coronal sulcus, penile shaft) reported consistently higher prevalence than single‐site studies [46], and broader HPV genotype panels naturally yield higher rates. These inconsistencies in methodology underscore the need for standardised sampling and testing protocols to improve comparability and global burden estimates.
+
+Geographical and socioeconomic factors also shaped prevalence patterns, mirroring trends in clearance. According to the 2023 Bruni et al. genital prevalence study [41], high‐income countries reported higher pooled prevalence for any HPV, HR‐HPV, and HPV16 (e.g., 34% vs. 28% for any HPV). These differences likely reflect greater access to diagnostics capacity and surveillance. Conversely, low‐ and middle‐income countries face higher infection risk due to limited vaccination, healthcare access, and sexual health education. Nearly half of the dataset originated from Europe and the Americas, underscoring underrepresentation of low and middle‐income regions. This imbalance constrains global HPV burden estimates and risks perpetuating disparities in prevention and treatment. Addressing these gaps through targeted investment in research, education, and healthcare infrastructure is essential to reducing HPV‐related inequities.
+
+Progress has been made in closing the long‐standing gap in oral HPV data among healthy men. Alemany et al. (2025) [47] conducted a multinational study of 7674 adults (16–80 years) using data from dental clinics in five high‐income countries, with males comprising nearly half the cohort. Oral HPV, particularly HR‐HPV types, were consistently more prevalent in men. In the UK, for instance, 15.0% of men tested positive for any oral HPV compared to 6.8% of women, and HR‐HPV was found in 4.5% of men versus 1.2% of women. Risk factors included older age, marijuana use, and a high number of lifetime oral sex partners, while conditions such as periodontitis may also have contributed to the variation of prevalence across countries. As one of the largest recent studies on male HPV, this investigation highlights older men as having the highest oral HPV burden, parallelling rising rates of HPV‐related oropharyngeal cancer [17]. The findings represent missed opportunities for prevention as well as the need for targeted vaccination and screening beyond adolescence. Although focused on high‐income countries, the study supports expanding oral HPV research globally.
+
+6 High‐Risk HPV‐Related Disease
+
+Cervical cancer remains the most widely recognised HPV‐related malignancy in women, with over 90% of cases attributed to HR‐HPV types, primarily HPV16 and HPV18 [48, 49]. Screening and vaccination programs have reduced incidence in many high‐income countries [50, 51], yet cervical cancer continues to impose a substantial global health burden. It remains one of the leading causes of cancer‐related mortality among women, especially in low‐ and middle‐income countries where access to preventive measures is limited [52]. In 2020, approximately 604,127 new cases of cervical cancer and 341,831 deaths were reported [4], emphasising the need for further research into causes and prevention methods.
+
+While cervical cancer has long dominated HPV research, HPV‐associated cancers in men, particularly head and neck squamous cell carcinoma (HNSCC), specifically oropharyngeal cancer, have emerged as a critical public health concern. HNSCC encompasses malignancies of the oral cavity, pharynx, and larynx. Oropharyngeal cancers affect the tonsils, base of the tongue, and soft palate and are the most rapidly rising HPV‐associated malignancy in men [53, 54]. In the USA, 70%–80% of these cancers are HPV‐positive, predominantly HPV16, surpassing traditional risk factors like tobacco and alcohol [17, 55]. Between 1988 and 2004, HPV positive oropharyngeal cancers increased by 225%, with men disproportionately affected [3, 56].
+
+Anal cancer is another HPV‐related malignancy affecting both sexes, with higher overall incidence in women although high‐risk men, particularly MSM and individuals with HIV, face markedly elevated rates [57]. Among MSM with HIV, incidence exceeds 131 per 100,000 annually, a rate comparable to pre‐screening cervical cancer in women [58, 59, 60]. These findings cement the need for research in both high‐risk men and the general population. Evidence also suggests that genital HPV infections may act as precursors to anal cancer through inter‐site transmission [61], reinforcing the need for comprehensive HPV prevention and detection strategies.
+
+HPV is also implicated in around 50% of invasive penile cancers [62], though estimates vary by study design and cancer subtype [63, 64]. Globally, penile cancer remains rare, with a 2020 Age‐Standardised Incidence Rate (ASIR) of 0.80 and a Age‐Specific Mortality Rate (ASMR) of 0.29 per 100,000, equating to 36,068 new cases and 13,211 deaths [65]. Incidence has risen in some regions, including a 21% increase in England between 1979 and 2009 [66], and GLOBOCAN projects a > 56% rise by 2040 [67]. The burden is disproportionately higher in low‐ and middle‐income countries, which account for nearly half of global deaths associated with the disease and show ASIR and ASMR rates nearly double those of high‐income regions [65].
+
+Beyond cancer, HPV has also been implicated in reproductive health. Persistent genital HPV has been linked to reduced sperm quality in men [68] and to endometrial inflammation and impaired implantation in women [69]. HPV is also associated with vulvar and vaginal cancers, which, though rare, are increasing in certain populations, likely due to rising HPV prevalence and delayed vaccination uptake [65, 70].
+
+7 Global Vaccination Strategies
+
+The introduction of three HPV vaccines ‐ Gardasil (2006), Cervarix (2007), and Gardasil 9 (2014) ‐ has represented a major leap forward in combating HPV‐related disease [71]. Gardasil, a quadrivalent vaccine, protects against HPV types 6, 11, 16, and 18, while Cervarix, a bivalent vaccine, protects against HR‐HPV types 16 and 18. Gardasil 9 expanded coverage to nine HPV types, protecting against HPV types that cause nearly 90% of HPV‐associated disease [72]. Studies show substantial declines in HPV prevalence, genital warts, and cervical precancerous lesions following vaccination [73]. In MSM, quadrivalent vaccination reduced anal HPV by 76% and penile infection by 52%, with notable decreases in HPV16/18 [74]. Vaccination in men also lowers oral HPV16 prevalence, a marker for oropharyngeal cancer [75].
+
+Since the introduction of the first HPV vaccine in 2006, global programs have focused on females due to heavy burden of cervical cancer, which is caused by HPV in over 90% of cases [48]. This female‐centric approach, based on expected herd immunity [76, 77], delayed male vaccination, with recommendations only being made in some regions from 2009 [78]. Implementation has remained uneven, exemplified by the 10‐year delay before boys were vaccinated in the UK [79]. Nevertheless, several organisations had previously advocated for a gender‐neutral vaccination approach, including the UK HPV Action Group, which published policy‐focused evidence supporting universal vaccination prior to its adoption by national health authorities in 2019 [80].
+
+Men's direct risk from HPV‐related cancers was largely overlooked in the early stages of vaccine implementation. In the UK, vaccination is offered to children aged 12 to 13 to establish immunity before potential exposure to the virus, often linked to sexual debut. This approach aligns with similar programs in other countries. This strategy has driven substantial declines in cervical cancer, with recent data showing effectiveness in women exceeding projections [4, 81]. For instance, cervical cancer mortality rate in US women under 25 has fallen to < 0.01 per 100,000 person‐years, alongside a long‐term drop from > 60 per 100,000 in the 1950s to < 15 by 2019–2021. Yet, the absence of early gender‐neutral vaccination has left a generation of men unvaccinated and at elevated risk of HPV‐related disease.
+
+These challenges have been exacerbated by the COVID‐19 pandemic, which disrupted healthcare services globally, including vaccination programs [6]. A marked decline in HPV vaccine uptake has been observed since the pandemic's onset, mirroring trends for other vaccines [82]. This decline stems from disruptions to routine healthcare, reduced school access (key to HPV vaccination programs), and the redirection of public health resources to COVID‐19 management. The pandemic has also fuelled vaccine hesitancy, partly due to distrust surrounding COVID‐19 vaccines, which has spilled over to HPV and other vaccinations. These disruptions risk reversing progress in HPV prevention and widening vaccination gaps, particularly for men. A global, comprehensive, gender‐neutral vaccination strategy is essential to address these gaps, including proactive vaccination of boys from adolescence and educational campaigns to raise awareness of HPV risks for both sexes. Such measures would not only protect men from HPV‐related cancers but also reduce HPV's overall public health burden, creating a more equitable and effective prevention strategy worldwide.
+
+8 Screening and Prevention Practices
+
+Currently, there are no routine HPV screening protocols for men. Testing usually occurs when symptoms such as genital warts are present, when a partner has an abnormal cervical screen, or incidentally in sexual health clinics. The absence of standardised screening for asymptomatic men leaves major gaps in prevention and early detection [7].
+
+Various methods for HPV detection in men have been explored to date. Penile swabs, which involve sampling from the glans, shaft, and coronal sulcus, have demonstrated higher HPV detection rates. Anal swabs and anal cytology are also utilised, primarily among high‐risk populations such as MSM or HIV‐positive men [83]. Additionally, urethral brushing, semen sampling, and self‐sampling methods have shown promise. Self‐collected genital samples in women have been found to achieve accuracy comparable to clinician‐collected samples, suggesting potential for broader applications [84]. However, these approaches remain unstandardised, and further research is needed to refine their sensitivity, reliability, and acceptability for widespread implementation.
+
+In contrast, women benefit from routine, proactive HPV screening measures, including Pap smears and HPV DNA testing. These methodologies offer different sensitivities; Pap smears have a sensitivity of 55.4% (95% CI, 33.6–77.2) and a specificity of 96.8% (95% CI, 96.3–97.3) for the detection of high‐grade cervical lesions, whereas HPV DNA testing demonstrates higher sensitivity (94.6% (95% CI, 84.2–100.0)) and lower specificity (94.1% (95% CI, 93.4–94.8) [85]. These screening methods have been shown to reduce cervical pre‐cancer and invasive cervical cancer incidence by upto 70% by detecting pre‐malignant lesions or high‐risk HPV infection before progression to invasive disease, enabling early clinical intervention [86]. Vaccination programs targeting HR‐HPV strains further bolster prevention strategies for women [51, 87].
+
+These limitations in HPV screening and prevention are more pronounced in low‐ and middle‐income countries (LMICs), where reported HPV prevalence is strongly influenced by healthcare infrastructure. In LMICs, HPV screening coverage is low, reflecting constraints in healthcare funding and laboratory availability, resulting in late diagnosis of cervical cancers [88]. HPV surveillance systems in LMICs are also often fragmented, with HPV data derived from small, urban‐based studies, cancer registries with incomplete population coverage, or research cohorts not integrated into national health reporting structures. This limits longitudinal monitoring of HPV infection and associated disease. In parallel, HPV vaccination coverage remains lower in LMICs [89] due to financial constraints, vaccine availability, and reduced programme reach.
+
+The absence of standardised HPV testing for men is especially concerning given the prevalence of asymptomatic carriers, who may unknowingly transmit the virus to their partners. Rising rates of HPV‐related cancers in men highlight the critical need for improved detection and prevention strategies. A comprehensive public health approach that combines standardised screening protocols for men with expanded vaccination initiatives could dramatically reduce HPV transmission and associated disease burdens, replicating the success achieved in women.
+
+9 Implementation
+
+The implementation of screening for HR‐HPV in men presents significant practical challenges, such as the lack of a specific HPV test for men as previously discussed. If routine screening were to be considered, it would be most appropriately targeted towards high‐risk groups, including men who have sex with men, immunocompromised individuals, and men who report sexual contact with HPV‐positive partners.
+
+Available HPV DNA tests are primarily for high‐risk genotypes; however, HPV infection alone does not constitute disease. Therefore, implementation should focus on the identification of pre‐malignant disease or malignancy rather than HPV positivity in isolation. Individuals who screen positive for HPV should have access to further clinical assessment or treatment, as is the case with women who test positive. Educational resources and councilling should also be provided so that HPV positive individuals can understand all potential outcomes.
+
+Given the asymptomatic nature of HPV in men before the onset of cancer, the feasibility of providing widespread screening, counselling and follow‐up within national healthcare systems, such as the NHS, remains uncertain due to resource and workforce constraints. Screening would likely be delivered through specialist health clinics or private clinical test centres, where appropriate expertise and follow‐up services would be available.
+
+10 Conclusion and Future Prospects
+
+In conclusion, HPV has the potential to persist in the male population, leading to a variety of cancers in the genital and head/neck regions. The persistence and transmission of HPV are shaped by multiple factors, including sexual behaviours, cultural norms, and individual health conditions such as age and immune status. These findings highlight the complexities of HPV epidemiology and natural history in men and underscore the existing gaps in understanding and addressing its full impact.
+
+There is a significant lack of comprehensive data on HPV in the general male population. Social stigma, limited awareness, and reactive testing protocols contribute to underreporting and hinder a full understanding of the true burden of the virus. As a result, many men remain at risk, with HPV‐related cancers like oropharyngeal cancer emerging as critical public health concerns. These statistics reinforce the urgent need for inclusive prevention strategies that extend to men.
+
+Given these findings, addressing the HR‐HPV burden in men requires immediate and comprehensive action. First, HPV testing for men must shift from reactive approaches to more structured, evidence‐informed screening focused on high‐risk groups. Such targeted approaches would enable earlier detection of HPV‐related malignancies, improve clinical outcomes, and provide data to better understand male HPV epidemiology. Concurrently, vaccination strategies should expand to a gender‐neutral approach, ensuring equitable access for boys and men and closing gaps left by earlier initiatives. Catch‐up vaccination for high‐risk populations is particularly important given evidence of higher infection prevalence, longer persistence, and elevated cancer risk in these groups.
+
+Public health policies must prioritise rebuilding vaccine confidence and providing accurate information to the public, addressing misinformation, stigma, and pandemic‐related disruptions to HPV prevention services. Future research should explore HPV's role in non‐cancerous conditions and male reproductive health, examine inter‐site transmission, and include underrepresented populations such as older and heterosexual men. By focussing on structured high‐risk screening, equitable vaccination, and targeted public engagement, the global burden of HR‐HPV in men can be realistically reduced, ensuring that both men and women benefit from advances in HPV prevention.
+
+Author Contributions
+
+K.L.C: conceptualisation, literature review, initial draft writing, reviewing and editing. E.L.M.: project supervision, writing, reviewing and editing. Both authors have read and agreed to the published version of the manuscript.
+
+Funding
+
+The authors have nothing to report.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Data Availability Statement
+
+Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
+
+
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+
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+36 C. M. Pierce Campbell , A. R. Kreimer , H. Y. Lin , et al., “Long‐Term Persistence of Oral Human Papillomavirus Type 16: The HPV Infection in Men (HIM) Study,” Cancer Prevention Research 8, no. 3 (March 2015): 190–196, 10.1158/1940-6207.capr-14-0296.25575501 PMC4355174
+37 H. Trottier , S. Mahmud , J. C. Prado , et al., “Type‐Specific Duration of Human Papillomavirus Infection: Implications for Human Papillomavirus Screening and Vaccination,” Journal of Infectious Diseases 197, no. 10 (May 2008): 1436–1447, 10.1086/587698.18419547 PMC7889327
+38 M. L. Gillison , T. Broutian , R. K. Pickard , et al., “Prevalence of Oral HPV Infection in the United States, 2009‐2010,” JAMA 307, no. 7 (February 2012): 693–703, 10.1001/jama.2012.101.22282321 PMC5790188
+39 D. J. Ingles , H. Y. Lin , W. J. Fulp , et al., “An Analysis of HPV Infection Incidence and Clearance by Genotype and Age in Men: The HPV Infection in Men (HIM) Study,” Papillomavirus Research 1 (December 2015): 126–135, 10.1016/j.pvr.2015.09.001.27547836 PMC4986989
+40 D. R. Brown and B. Weaver , “Human Papillomavirus in Older Women: New Infection or Reactivation?,” Journal of Infectious Diseases 207, no. 2 (January 2013): 211–212, 10.1093/infdis/jis662.23242539 PMC3532821
+41 L. Bruni , G. Albero , J. Rowley , et al., “Global and Regional Estimates of Genital Human Papillomavirus Prevalence Among Men: A Systematic Review and Meta‐Analysis,” Lancet Global Health 11, no. 9 (September 2023): e1345–e1362, 10.1016/s2214-109x(23)00305-4.37591583 PMC10447222
+42 L. Bruni , M. Diaz , M. Castellsagué , E. Ferrer , F. X. Bosch , and S. de Sanjosé , “Cervical Human Papillomavirus Prevalence in 5 Continents: Meta‐Analysis of 1 Million Women With Normal Cytological Findings,” Journal of Infectious Diseases 202, no. 12 (December 2010): 1789–1799, 10.1086/657321.21067372
+43 Q. Luo , X. Zeng , H. Luo , et al., “Epidemiologic Characteristics of high‐risk HPV and the Correlation Between Multiple Infections and Cervical Lesions,” BMC Infectious Diseases 23, no. 1 (October 2023): 667, 10.1186/s12879-023-08634-w.37805467 PMC10560423
+44 CDC , “Chapter 11: Human Papillomavirus. [Online] Epidemiology and Prevention of Vaccine‐Preventable Diseases,”(2024), https://www.cdc.gov/pinkbook/hcp/table‐of‐contents/chapter‐11‐human‐papillomavirus.html.
+45 X. Wei , J. Zhang , Y. Mei , Q. Dai , X. Yang , and X. Wang , “Prevalence and Genotype Distribution of HPV6/11/16/18 Infections Among 180,276 Outpatient Females From a Women’s and Children’s Central Hospital, 2015–2021, Chengdu, China,” Scientific Reports 13, no. 1 (December 2023): 22249, 10.1038/s41598-023-48222-1.38097632 PMC10721790
+46 C. M. Nielson , R. B. Harris , E. F. Dunne , et al., “Risk Factors for Anogenital Human Papillomavirus Infection in Men,” Journal of Infectious Diseases 196, no. 8 (October 2007): 1137–1145, 10.1086/521632.17955431 PMC3877918
+47 L. Alemany , M. Felsher , A. R. Giuliano , et al., “Oral Human Papillomavirus (HPV) Prevalence and Genotyping Among Healthy Adult Populations in the United States and Europe: Results From the PROGRESS (Prevalence of Oral Hpv Infection, a Global Assessment) Study,” eClinicalMedicine 79 (January 2025): 103018, 10.1016/j.eclinm.2024.103018.39896062 PMC11786696
+48 P. A. Cohen , A. Jhingran , A. Oaknin , and L. Denny , “Cervical Cancer,” Lancet 393, no. 10167 (January 2019): 169–182, 10.1016/s0140-6736(18)32470-x.30638582
+49 S. Ramakrishnan , S. Partricia , and G. Mathan , “Overview of high‐risk Hpv's 16 and 18 Infected Cervical Cancer: Pathogenesis to Prevention,” Biomedicine & Pharmacotherapy 70 (March 2015): 103–110, 10.1016/j.biopha.2014.12.041.25776487
+50 J. Lei , A. Ploner , K. M. Elfström , et al., “HPV Vaccination and the Risk of Invasive Cervical Cancer,” New England Journal of Medicine 383, no. 14 (October 2020): 1340–1348, 10.1056/nejmoa1917338.32997908
+51 M. Falcaro , A. Castañon , B. Ndlela , et al., “The Effects of the National HPV Vaccination Programme in England, UK, on Cervical Cancer and Grade 3 Cervical Intraepithelial Neoplasia Incidence: A Register‐Based Observational Study,” Lancet 398, no. 10316 (December 2021): 2084–2092, 10.1016/s0140-6736(21)02178-4.34741816
+52 R. Hull , M. Mbele , T. Makhafola , et al., “Cervical Cancer in Low and Middle‐Income Countries,” Oncology Letters 20, no. 3 (September 2020): 2058–2074, 10.3892/ol.2020.11754.32782524 PMC7400218
+53 D. E. Johnson , B. Burtness , C. R. Leemans , V. W. Lui , J. E. Bauman , and J. R. Grandis , “Head and Neck Squamous Cell Carcinoma,” Nature Reviews Disease Primers 6, no. 1 (November 2020): 92, 10.1038/s41572-020-00224-3.PMC7944998 33243986
+54 Z. S. Zumsteg , M. Luu , P. S. Rosenberg , et al., “Global Epidemiologic Patterns of Oropharyngeal Cancer Incidence Trends,” Journal of the National Cancer Institute: Journal of the National Cancer Institute 115, no. 12 (December 2023): 1544–1554, 10.1093/jnci/djad169.37603716 PMC10699798
+55 L. Q. Chow , “Head and Neck Cancer,” New England Journal of Medicine 382, no. 1 (January 2020): 60–72, 10.1056/nejmra1715715.31893516
+56 F. Guo , M. Chang , M. Scholl , B. McKinnon , and A. B. Berenson , “Trends in Oropharyngeal Cancer Incidence Among Adult Men and Women in the United States From 2001 to 2018,” Frontiers in Oncology 12 (July 2022): 926555, 10.3389/fonc.2022.926555.35924171 PMC9339703
+57 S. Mignozzi , C. Santucci , M. Malvezzi , F. Levi , C. La Vecchia , and E. Negri , “Global Trends in Anal Cancer Incidence and Mortality,” European Journal of Cancer Prevention 33, no. 2 (March 2024): 77–86, 10.1097/cej.0000000000000842.38047709 PMC10833181
+58 A. A. Deshmukh , H. Damgacioglu , D. Georges , K. Sonawane , and G. M. Clifford , “Human papillomavirus‐Associated Anal Cancer Incidence and Burden Among US Men, According to Sexual Orientation, Human Immunodeficiency Virus Status, and Age,” Clinical Infectious Diseases 77, no. 3 (August 2023): 419–424, 10.1093/cid/ciad205.37017078 PMC10681657
+59 M. Frisch , R. J. Biggar , and J. J. Goedert , “Human papillomavirus‐associated Cancers in Patients With Human Immunodeficiency Virus Infection and Acquired Immunodeficiency Syndrome,” Journal of the National Cancer Institute: Journal of the National Cancer Institute 92, no. 18 (September 2000): 1500–1510, 10.1093/jnci/92.18.1500.10995805
+60 B. Hirsch , R. M. Vail , S. S. Shah , et al., Screening for Anal Dysplasia and Cancer in Adults with HIV. Johns Hopkins University, https://www.ncbi.nlm.nih.gov/books/NBK556472/.32369310
+61 B. Y. Hernandez , K. McDuffie , X. Zhu , et al., “Anal Human Papillomavirus Infection in Women and Its Relationship With Cervical Infection,” Cancer Epidemiology Biomarkers & Prevention 14, no. 11 (November 2005): 2550–2556, 10.1158/1055-9965.epi-05-0460.PMC1475824 16284377
+62 S. Kristiansen , C. Bjartling , C. Torbrand , et al., “Increased Prevalence of Human Papillomavirus in Fresh Tissue From Penile Cancers Compared to Non‐malignant Penile Samples: A case‐control Study,” BMC Cancer 22, no. 1 (November 2022): 1227, 10.1186/s12885-022-10324-w.36443686 PMC9703753
+63 T. B. Olesen , F. L. Sand , C. L. Rasmussen , et al., “Prevalence of Human Papillomavirus DNA and p16INK4a in Penile Cancer and Penile Intraepithelial Neoplasia: A Systematic Review and Meta‐Analysis,” Lancet Oncology 20, no. 1 (January 2019): 145–158, 10.1016/s1470-2045(18)30682-x.30573285
+64 C. Miralles‐Guri , L. Bruni , A. L. Cubilla , X. Castellsague , F. X. Bosch , and S. De Sanjose , “Human Papillomavirus Prevalence and Type Distribution in Penile Carcinoma,” Journal of Clinical Pathology 62, no. 10 (October 2009): 870–878, 10.1136/jcp.2008.063149.19706632
+65 L. Fu , T. Tian , K. Yao , et al., “Global Pattern and Trends in Penile Cancer Incidence: Population‐Based Study,” JMIR Public Health and Surveillance 8, no. 7 (July 2022): e34874, 10.2196/34874.35793140 PMC9301560
+66 M. Arya , R. Li , K. Pegler , et al., “Long‐Term Trends in Incidence, Survival and Mortality of Primary Penile Cancer in England,” Cancer Causes & Control 24, no. 12 (December 2013): 2169–2176, 10.1007/s10552-013-0293-y.24101363
+67 F. Bray , J. Ferlay , I. Soerjomataram , R. L. Siegel , L. A. Torre , and A. Jemal , “Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries,” CA: A Cancer Journal for Clinicians 68, no. 6 (November 2018): 394–424, 10.3322/caac.21492.30207593
+68 Y. Yang , C. W. Jia , Y. M. Ma , L. Y. Zhou , and S. Y. Wang , “Correlation Between HPV Sperm Infection and Male Infertility,” Asian Journal of Andrology 15, no. 4 (April 2013): 529–532, 10.1038/aja.2013.36.23603919 PMC3739240
+69 N. Pereira , K. M. Kucharczyk , J. L. Estes , et al., “Human Papillomavirus Infection, Infertility, and Assisted Reproductive Outcomes,” Journal of Pathogens 2015, no. 1 (2015): 578423–578428, 10.1155/2015/578423.26609434 PMC4644557
+70 A. Reid , O. Kovalenko , J. Gordon , and L. Ferguson , “Changes in Vulvar Cancer Incidence From Before COVID‐19 Through the First Year of the Pandemic (350),” Gynecologic Oncology 166 (August 2022): S179, 10.1016/s0090-8258(22)01572-4.
+71 World Health Organization , “Human Papillomavirus Vaccines: WHO Position Paper (2022 Update),” Weekly Epidemiological Record 97, no. 50 (December 2022): 645–672, https://www.who.int/publications/i/item/who‐wer9750‐645‐672.
+72 L. Cheng , Y. Wang , and J. Du , “Human Papillomavirus Vaccines: An Updated Review,” Vaccines 8, no. 3 (July 2020): 391, 10.3390/vaccines8030391.32708759 PMC7565290
+73 M. Drolet , É Bénard , M. C. Boily , et al., “Population‐Level Impact and Herd Effects Following Human Papillomavirus Vaccination Programmes: A Systematic Review and Meta‐Analysis,” Lancet Infectious Diseases 15, no. 5 (May 2015): 565–580, 10.1016/s1473-3099(14)71073-4.25744474 PMC5144106
+74 E. P. Chow , S. N. Tabrizi , C. K. Fairley , et al., “Prevalence of Human Papillomavirus in Young Men Who Have Sex With Men After the Implementation of Gender‐Neutral HPV Vaccination: A Repeated Cross‐Sectional Study,” Lancet Infectious Diseases 21, no. 10 (October 2021): 1448–1457, 10.1016/s1473-3099(20)30687-3.34043963
+75 P. Macilwraith , E. Malsem , and S. Dushyanthen , “The Effectiveness of HPV Vaccination on the Incidence of Oropharyngeal Cancers in Men: A Review,” Infectious Agents and Cancer 18, no. 1 (April 2023): 24, 10.1186/s13027-022-00479-3.37095546 PMC10127083
+76 E. M. Daley , C. A. Vamos , G. D. Zimet , Z. Rosberger , E. L. Thompson , and L. Merrell , “The Feminization of HPV: Reversing Gender Biases in US Human Papillomavirus Vaccine Policy,” American Journal of Public Health 106, no. 6 (June 2016): 983–984, 10.2105/ajph.2016.303122.27153015 PMC4880257
+77 S. K. Kjaer , C. Dehlendorff , F. Belmonte , and L. Baandrup , “Real‐World Effectiveness of Human Papillomavirus Vaccination Against Cervical Cancer,” Journal of the National Cancer Institute: Journal of the National Cancer Institute 113, no. 10 (October 2021): 1329–1335, 10.1093/jnci/djab080.33876216 PMC8486335
+78 P. L. Reiter , A. L. McRee , J. A. Kadis , and N. T. Brewer , “HPV Vaccine and Adolescent Males,” Vaccine 29, no. 34 (August 2011): 5595–5602, 10.1016/j.vaccine.2011.06.020.21704104 PMC3143221
+79 A. Green , “HPV Vaccine to Be Offered to Boys in England,” Lancet 392, no. 10145 (August 2018): 374, 10.1016/s0140-6736(18)31728-8.30152370
+80 G. Prue , G. Shapiro , R. Maybin , O. Santin , and M. Lawler , “Knowledge and Acceptance of Human Papillomavirus (HPV) and HPV Vaccination in Adolescent Boys Worldwide: A Systematic Review,” Journal of Cancer Policy 10 (December 2016): 1–15, 10.1016/j.jcpo.2016.09.009.
+81 P. Dorali , H. Damgacioglu , M. A. Clarke , et al., “Cervical Cancer Mortality Among US Women Younger Than 25 Years, 1992‐2021,” JAMA 333, no. 2 (January 2025): 165–166, 10.1001/jama.2024.22169.39602175 PMC11733696
+82 B. Z. Kahn , Q. Huang , P. Thompson , M. B. Gilkey , S. A. Dailey , and N. T. Brewer , “Getting Human Papillomavirus Vaccination Back on Track: A National Survey,” Journal of Adolescent Health 72, no. 6 (June 2023): 950–957, 10.1016/j.jadohealth.2023.01.004.PMC10010471 36922312
+83 R. S. Dube Mandishora , T. B. Rounge , M. Fitzpatrick , et al., “Self‐Collected and Clinician‐Collected Anal Swabs Show Modest Agreement for HPV Genotyping,” PLoS One 16, no. 4 (April 2021): e0250426, 10.1371/journal.pone.0250426.33901223 PMC8075200
+84 M. Arbyn , F. Verdoodt , P. J. Snijders , et al., “Accuracy of Human Papillomavirus Testing on Self‐Collected Versus Clinician‐Collected Samples: A Meta‐Analysis,” Lancet Oncology 15, no. 2 (February 2014): 172–183, 10.1016/s1470-2045(13)70570-9.24433684
+85 M. H. Mayrand , E. Duarte‐Franco , I. Rodrigues , et al., “Human Papillomavirus DNA Versus Papanicolaou Screening Tests for Cervical Cancer,” New England Journal of Medicine 357, no. 16 (October 2007): 1579–1588, 10.1056/nejmoa071430.17942871
+86 R. Landy , F. Pesola , A. Castañón , and P. Sasieni , “Impact of Cervical Screening on Cervical Cancer Mortality: Estimation Using Stage‐Specific Results from a Nested case–control Study,” British Journal of Cancer 115, no. 9 (October 2016): 1140–1146, 10.1038/bjc.2016.290.27632376 PMC5117785
+87 M. Falcaro , A. Castañón , B. Ndlela , and P. Sasieni , “Association Between HPV Vaccination and Cervical Screening Policy Changes and Cervical Cancer Incidence and Grade‐3 Cervical Intraepithelial Neoplasia Incidence in England, 2006–2020: A Population‐Based Trends Analysis,” Lancet Regional Health–Europe 1 (February 2025): 49, 10.1016/j.lanepe.2024.101157.PMC11697118 39759575
+88 E. R. Allanson and K. M. Schmeler , “Cervical Cancer Prevention in low‐and Middle‐Income Countries,” Clinical Obstetrics and Gynecology 64, no. 3 (September 2021): 501–518, 10.1097/grf.0000000000000629.34120126 PMC8324570
+89 L. Pak , J. Rollison , M. Rabinowitz , and L. J. Faherty , “Human Papillomavirus Vaccine Coverage Surveys in low‐ and Middle‐Income Countries: Current Efforts and Future Considerations for Very Young Adolescents,” BMJ Global Health 10, no. 6 (2025): e018731, 10.1136/bmjgh-2024-018731.PMC12164605 40514218
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS ONE
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11844851
+PMID: 39982873
+DOI: 10.1371/journal.pone.0316278
+Article ID: PONE-D-24-30573
+Article version: 1
+Subjects: Study Protocol, Medicine and Health Sciences, Medical Conditions, Noncommunicable Diseases, Medicine and Health Sciences, Health Care, Health Care Policy, Medicine and Health Sciences, Health Care, Communication in Health Care, Medicine and Health Sciences, Health Care, Primary Care, Medicine and Health Sciences, Health Care, Medical Services, Telemedicine, Medicine and Health Sciences, Public and Occupational Health, Global Health, Medicine and Health Sciences, Oncology, Cancers and Neoplasms, Lung and Intrathoracic Tumors, Research and Analysis Methods, Database and Informatics Methods, Database Searching
+
+Impact of digital health on the quality of primary care for people with chronic noncommunicable diseases: A scoping review protocol
+
+Impact of digital health on the quality of primary care for people with chronic noncommunicable diseases
+
+https://orcid.org/0000-0002-4212-1551 Xavier Pedro Bezerra Conceptualization Data curation Formal analysis Investigation Methodology Resources Supervision Writing – original draft Writing – review & editing 1 *
+Silva Ísis de Siqueira Conceptualization Data curation Formal analysis Investigation Supervision Writing – original draft Writing – review & editing 2
+de Figueiredo Renan Cabral Conceptualization Data curation Validation Writing – original draft 3
+de Araújo Aguinaldo José Conceptualization Data curation Formal analysis Investigation Writing – original draft 2
+da Silva Amanda Jéssica Bernardo Investigation Resources Writing – original draft 4
+Uchôa Severina Alice da Costa Conceptualization Data curation Formal analysis Investigation Methodology Project administration Supervision Validation Writing – original draft Writing – review & editing 3
+1 Health Sciences Center, Postgraduate in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil
+2 Department of Collective Health, Postgraduate Studies in Public Health, Federal University of Rio Grande do Norte, Natal, Brazil
+3 Department of Collective Health, Federal University of Rio Grande do Norte, Natal, Brazil
+4 Department of Medical Sciences, Federal University of Rio Grande do Norte, Natal, Brazil
+Rizzato Stopa Sheila Editor
+Health Researcher, BRAZIL
+Competing Interests: The authors have declared that no competing interests exist.
+
+* E-mail: pedrobx37@gmail.com
+Electronic publication date: 2025 Feb 21
+Publication date: 2025
+Volume: 20
+Issue: 2
+Electronic Location ID: e0316278
+Received 2024 Aug 11; Accepted 2024 Dec 9
+Copyright: © 2025 Xavier et al
+Copyright year: 2025
+Copyright holder: Xavier et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Funding: CAPES 001 https://orcid.org/0000-0002-4212-1551 Xavier Pedro Bezerra This study was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001.
+
+Figure count: 1
+Table count: 3
+Page count: 14
+Data Availability: All relevant data are within the manuscript and its Supporting Information files.
+
+Data Availability
+
+All relevant data are within the manuscript and its Supporting Information files.
+
+Ÿ==============================Ÿ
+Background
+
+Chronic Non-Communicable Diseases (NCDs) represent a significant global challenge, especially in low- and middle-income countries. The introduction of digital health in Primary Health Care (PHC) has the potential to improve the quality of care for people with NCDs by offering tools such as telemedicine, mobile applications and other information and communication technologies. The aim of this study is to identify and map global experiences of using Information and Communication Technologies (ICTs) in primary care for non-communicable diseases and assess their impact on the quality of care in PHC.
+
+Methods
+
+This study presents a scoping review protocol based on the Joanna Briggs Institute criteria and the PRISMA-ScR guidelines. The review will be carried out in nine stages, including defining the aim and research questions, developing inclusion and exclusion criteria, and searching, selecting, extracting and analyzing the evidence. The databases consulted include MEDLINE/PubMed, JBI Evidence Synthesis and Open Science Framework.
+
+Results
+
+The review will identify and map global experiences in the use of ICTs in primary care for NCDs and assess their impact on the quality of care in PHC. It is hoped to find studies that address the use of digital technologies for early detection, management and follow-up of NCDs, as well as their integration with traditional health systems.
+
+Conclusions
+
+The integration of digital technologies into PHC has the potential to improve the quality of care, but it can also accentuate inequities. It is necessary to consider digital health literacy, access to tools, and legal and ethical aspects of data protection. The review will highlight the need for robust policies and adequate infrastructure to support the effective implementation of digital health in PHC.
+
+Introduction
+
+Chronic Non-Communicable Diseases (NCDs), including cardiovascular, chronic respiratory, and metabolic conditions, are major contributors to global morbidity and premature mortality, disproportionately impacting low- and middle-income countries [1, 2]. Addressing these challenges requires health systems to provide efficient, cost-effective care, with Primary Health Care (PHC) playing a critical role in care coordination [3, 4].
+
+PHC is central to reducing premature NCDs mortality, aligning with the Sustainable Development Goals to improve accessibility, community focus, and comprehensive care [5, 6]. Since COVID-19, digital health has significantly expanded within PHC, enhancing the detection, management, and monitoring of NCDs. This integration of technologies such as mobile apps and telemedicine supports personalized, equitable health services, thereby strengthening the coordination of NCDs care [7, 8].
+
+Digital health, as defined by the World Health Organization (WHO), encompasses Information and Communication Technologies (ICTs) applications like telemedicine, mHealth, health records, Artificial Intelligence, and more [9–11]. However, while promising, technology can also deepen inequities if factors like digital literacy, easy access to the necessary tools, legal and ethical aspects in protecting the data generated and, above all, the influence of the social determinants of health on the use of this technology are not addressed [12, 13].
+
+An exploratory search was conducted from January to April 2024 using MEDLINE/PubMed, Open Science Framework (OSF), and Google Scholar with the terms "Noncommunicable Diseases," "Digital Health," and "Primary Health Care," combined with the Boolean operator AND. This search identified eight systematic reviews on topics including: telemedicine in diabetes care for middle- and low-income countries [14]; telemedicine applications in Chronic Obstructive Pulmonary Disease (COPD) [15]; smartphone applications targeting physical activity [16]; digital tools assessing functional capacity in patients with type 2 diabetes mellitus [17]; the application of Artificial Intelligence (AI) to enhance primary healthcare [18]; health professionals’ perceptions of telehealth usability in primary care for NCDs patients [19]; quality of life analysis in asthma patients using interactive telehealth [20]; and users’ perspectives on eHealth and mHealth services in lifestyle and NCDs prevention [21].
+
+Achieng and Ogundaini [22] conducted a scoping review on digital health and chronic disease self-management in sub-Saharan Africa, exploring region-specific implementation challenges and benefits. Additionally, Xiong et al. [23] examined the impact of factors such as political commitment, interactivity, user-centered design.
+
+Few studies have examined the long-term effects of digital health interventions, leaving a notable gap in understanding the sustainability of these solutions and the sustained adherence of patients with NCDs [24]. Additionally, integrating digital health technologies into traditional healthcare systems and achieving interoperability across various platforms remain frequent challenges [25]. Moreover, the reliance on technology raises concerns about accessibility, particularly in regions with inconsistent internet connectivity or power supply, potentially exacerbating health disparities. Data privacy and security are also significant concerns, as the collection and storage of sensitive patient information can lead to mistrust in digital solutions if cybersecurity threats arise [26]. Furthermore, user experience plays a crucial role; poorly designed interfaces can discourage usage, leading to underutilization of these technologies and ultimately failing to achieve their intended impact [23]. Furthermore to the points already mentioned, the economic interests focused on digital health are currently concentrated in the hands of a few multinational technology corporations, mostly based in the Global North. These corporations exert enormous influence over research agendas, policies, infrastructures, and digital health technology implementations, which may limit access to the benefits of digital health for certain patient groups [26].
+
+While existing evidence contributes significantly to evaluating digital technologies for NCDs care, studies no comprehensive scoping or systematic reviews were found that thoroughly explore the integration of digital health within national policies and systems, nor their impact on key PHC quality attributes—such as access, continuity, holistic care, management, community focus, family-centeredness, and cultural sensitivity [27], which are essential to NCDs management. Therefore, this protocol proposes a Scoping Review to identify and map digital health applications in primary care for NCDs and evaluate their impact on PHC quality.
+
+The conceptual framework for quality will be grounded in Donabedian’s model [28], which defines health quality through three interrelated components: structure, process, and outcome. The structure encompasses the physical, human, and organizational resources for healthcare delivery, including technological infrastructure, qualified professionals, and access to devices. The process involves the activities performed by healthcare professionals, focusing on the technical, organizational, and relational dimensions of digital care. Lastly, the outcome evaluates the effects of care on patients’ and the community’s health, assessing factors such as access, effectiveness, and patient satisfaction with the care received.
+
+This review will emphasize the necessity for robust policies and adequate infrastructure to facilitate effective and sustainable digital health implementation in PHC. It will also highlight the significance of continuous innovations to enhance NCDs management.
+
+Methods
+
+This is a Scoping Review protocol based on the Joanna Briggs Institute (JBI) criteria, guided by the theoretical framework of Arksey and O’malley [29], with updates by Levac [30] and Peters [31], as well as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) [32, 33].
+
+For the organization of this study, a search was conducted in the MEDLINE/PubMed, JBI Evidence Synthesis, and Open Science Framework repositories, aiming to identify knowledge gaps and previous and/or ongoing reviews that are similar. No other identical study was found. This protocol was registered in the OSF [34].
+
+To guide the study, nine steps will be developed as recommended by JBI [31, 35]. They are: Definition and alignment of the objective and question; development of inclusion criteria with the objective and questions; description and planning of the approach for evidence search, selection, data extraction, and presentation of evidence; evidence search; evidence selection; evidence extraction; evidence analysis; presentation of results; and summarizing the evidence in relation to the review objective, drawing conclusions, and noting any implications of the results. All steps are detailed below:
+
+Define and align the objective and question
+
+Definition of PCC
+
+Based on the definition of the PCC mnemonic (Population, Concept, and Context) [31], available in Table 1, the objective of the research question was defined.
+
+10.1371/journal.pone.0316278.t001 Table 1 Definition of the PCC mnemonic.
+
+Mnemonic	Description	
+Pa	People with NCDs	
+Cb	Digital Health and quality of healthcare	
+Cc	Primary Health Care	
+a–Population; b–Concept; c–Context.
+
+Objective
+
+To identify and map global experiences of using ICTs in primary care for NCDs and to assess their impact on the quality of care in PHC.
+
+Research questions
+
+Which countries use ICTs in the care of NCDs in PHC?
+
+What digital resources (applications, types, and tools) are used in the care, prevention, and promotion of health for people with NCDs in the scope of PHC?
+
+What is the impact of digital technologies on the quality of care for people with NCDs in PHC?
+
+Definition of the concepts defined in the PCC
+
+The definition of the concepts used in this research is presented in Table 2.
+
+10.1371/journal.pone.0316278.t002 Table 2 Description of the concepts used in this research.
+
+Concept	Description	
+People diagnosed with non-communicable diseases	People diagnosed with non-communicable diseases (NCDs), which are diseases that develop over a lifetime, are generally slow, silent, and asymptomatic, but can significantly affect the quality of life and pose serious risks to individuals. The most important NCDs include cardiovascular diseases, chronic respiratory diseases (bronchitis, asthma, rhinitis), hypertension, cancer, diabetes, and metabolic diseases (obesity, diabetes, dyslipidemia) [36].	
+Digital Health	Digital health is a broad, economical, and secure field that applies Information and Communication Technologies (ICTs), including remote health services (telehealth) and remote consultations (telemedicine, telenursing, among others). ICTs encompasses support from computers, mobile phones, the internet, videos, text messages, websites, platforms, information systems, electronic records; mobile health (mHealth); and emerging technologies such as big data, genomics, and artificial intelligence [10].	
+Healthcare	Healthcare is that which attends to, respects, welcomes, and helps people who suffer—primarily due to their social vulnerability—while ensuring quality and treatment of their problems. It is an integrated work resulting from the "relationships between people," meaning it is the product of positive interactions between users, professionals, and institutions [37].	
+Quality of Care	The quality of healthcare is the ability of services to improve desired health outcomes for individuals and populations, based on evidence-based knowledge. To be considered high-quality, healthcare must be effective, providing evidence-based services to those who need them; safe, avoiding harm to patients; and person-centered, addressing their preferences, needs, and values [38].	
+Evaluation of Care Quality	The quality of healthcare will be assessed using Donabedian’s theoretical framework [28, 39] utilizing the following parameters:	
+Structure: This pertains to physical resources, staff, and financial resources, as well as organizational structure, infrastructure, and normative and strategic resources (protocols, guidelines) that comprise the provision of healthcare.	
+Process: These are the activities related to health care, involving the interaction between professionals and users. This component will be evaluated considering technical, organizational, and relational dimensions. Outcome: This refers to the direct changes in the health status of individuals and the community. To verify the outcomes of using digital health in primary care for people with NCDs, this study will evaluate the impact of ICTs on the essential attributes of PHC, which are first contact, longitudinality, comprehensiveness, and coordination of healthcare.	
+Source: Prepared by the author, 2024.
+
+Develop and align the inclusion criteria with the objective and questions
+
+Inclusion criteria
+
+The following will be included: a) primary studies published in full; b) grey literature; c) theses, dissertations, and official documents (governmental and from health institutions or organizations).
+
+The search criteria will have no restrictions on time and language, which is a key characteristic of a Scoping Review. The terms and descriptors used will focus on digital health, which will impose a temporal limitation on the topic. It should be noted that this is a recent topic, and the term "digital health" has become more commonly used following the publication of the Guideline Recommendations on Digital Interventions for Health System Strengthening [10].
+
+Exclusion criteria
+
+Publications that will be excluded are duplicates, literature reviews, letters, book chapters, theoretical essays, editorials, abstracts and brief presentations, and expert opinions.
+
+Description and planning of the approach for evidence search, selection, data extraction, and presentation of evidence
+
+As per JBI guidelines [31], the search methodology follows three stages: exploratory search to identify potential uncontrolled search terms, keywords, and indexed descriptors. After identifying the descriptors and keywords, an initial exploratory search was conducted in the MEDLINE/PubMed to identify publications and, after reading the titles and abstracts, identify the most commonly used descriptors and keywords (Appendix 1 in S1 File).
+
+Following the identification of the most commonly used terms, a librarian refined the search strategy using controlled vocabularies, namely: Health Sciences Descriptors (DeCS), Medical Subject Headings (MeSH), Entree (Embase), as well as text words and subject headings, in order to obtain a comprehensive strategy and refine the results [40]. The standard search strategy is provided in Appendix 2 in S2 File.
+
+Search for evidence
+
+The standardized search strategy will be applied to search for evidence in both white and grey literature and will be adapted for each database, using the Boolean operators "AND" and "OR" as needed. The complete strategy used in MEDLINE/PubMed is available in Table 3, tested on May 04, 2024, yielding a total of 1,546 results.
+
+10.1371/journal.pone.0316278.t003 Table 3 Search strategy used in MEDLINE/PubMed.
+
+PCC	TERMS	
+P	"Noncommunicable Diseases"[Mh] OR "Noncommunicable Disease*"[ti] OR "Non-infectious Diseases"[tiab] OR "Non infectious Diseases"[tiab] OR "Non-communicable Disease"[tiab] OR "Non-communicable Chronic Diseases"[tiab] OR "Chronic Disease, Non-communicable"[tiab] OR "Non communicable Chronic Diseases"[tiab] OR "Non-communicable Chronic Disease"[tiab] "Diabetes Mellitus"[Mh] OR Diabetes[title] OR Hypertension[Mh] OR "High Blood Pressure*"[tiab] OR Neoplasms[MH] OR Tumor*[ti] OR Cancer*[tiab] OR "Malignant Neoplasm"[tiab] OR "Benign Neoplasm"[tiab] OR "Cardiovascular Diseases"[Mh] OR "Cardiovascular Disease*"[ti] OR "Cardiac Event*"[tiab] OR "Adverse Cardiac Event*"[ti] OR Infarction[Mh] OR Infarct*[ti] OR "Myocardial Infarction"[Mh] OR "Myocardial Infarction*"[tiab] OR "Cardiovascular Stroke*"[tiab] OR "Heart Attack*"[tiab] OR Stroke[Mh] OR Stroke*[title] OR "Cerebrovascular Accident*"[ti] OR CVA[title] OR "Cerebral Stroke"[tiab] OR "Acute Cerebrovascular Accident*"[tiab] OR "Heart Diseases"[Mh] OR "Heart Disease*"[title] OR "Cardiac Disease*"[title] OR "Heart Disorder*"[title] OR Asthma[Mh] OR Asthmas[title] OR "Bronchial Asthma"[ti] OR "Pulmonary Disease, Chronic Obstructive"[Mh] OR "Pulmonary Disease, Chronic Obstructive"[tiab] OR "Chronic Obstructive Lung Disease"[tiab] OR COAD[ti] OR COPD[ti] OR "Airflow Obstruction, Chronic"[tiab]	
+AND	
+C	(Ehealth[ti] OR e-Health[ti] OR telehealth[tiab] OR Telecare[tiab] OR mHealth[ti] OR Telerehabilitation[mh] OR Telereh*[ti] OR "home telehealth"[tiab] OR "Home telecare"[tiab] OR "virtual rehabilitation*"[tiab] OR telemonitoring[tiab] OR "telecare monitoring system"[tiab] OR telenursing[ti] OR "Digital Health"[tiab] OR "Digital Health Strateg*"[tiab] OR "Digital Health Interventions"[tiab] OR "eHealth Strategies and Policies"[tiab] OR Telemedicine[Mh] OR Telemed*[ti] OR "Virtual Medicine"[tiab] OR "information and communication Technolog*"[ti])	
+AND	
+C	"Primary Health care"[Mh] OR "Primary Health*"[title] OR "Health Care, Primary"[tiab] OR "Primary Healthcare"[ti] OR "Primary Care"[tiab] OR "first line care"[tiab] OR "general practi*"[ti] OR "primary medical care"[ti] OR "primary care nursing"[tiab] OR "Community mental health*"[tiab] OR "Family medicine"[ti] OR "Family physician*"[ti] OR "Community health*"[ti] OR "Community nurs*"[tiab] OR "Community pharmac*"[tiab] OR "Preventive care"[tiab] OR "Prevention program*"[tiab] OR "Preventive service*"[tiab] OR "Preventive health"[tiab] OR "Health promotion"[tiab] OR "Family health program"[tiab] OR "Family health strategy"[tiab]	
+TOTAL: 1,810 Results	
+Source: Prepared by the author, 2024.
+
+Data source
+
+Data collection will be conducted from the following portals and databases: MEDLINE/PubMed, LILACS/virtual health library (BVS), Scopus, Web of Science, Embase, Cochrane, Epistemonikos, Google Scholar, Digital Library of Theses and Dissertations, CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) Theses Portal, DART-E (European Electronic Theses and Dissertations (ETDs)—DART-Europe), ProQuest Dissertations & Theses Global. For Google Scholar, the selection will include the first 100 files found, sorted by relevance [41]. After selecting documents from the data sources, they will be exported to the reference manager EndNote, which will be used for reference storage and removal of duplicates (documents retrieved more than once from searches in different databases).
+
+Selection of evidence
+
+Pilot test of selection
+
+Before the selection, a pilot test will be conducted to calibrate the reviewers, enabling greater accuracy in the selection of studies. This action will simulate the evidence selection process, where a sample of 25 articles will be independently analyzed by pairs to identify possible inconsistencies and the need for adaptation of the extraction form [31].
+
+The extraction form (Appendix 3 in S3 File) will also be examined during the pilot test, where two team researchers will independently extract each evidence source according to the potential data items of interest, based on the PCC and the research question.
+
+Pollock and colleagues [42] support that during the pilot test, scoping review authors should reflect on the following questions:
+
+Was there anything missing from the extraction form?
+
+Was there anything redundant included in the extraction form?
+
+Was there anything in the extraction form that you did not understand or that could be clarified better?
+
+How much time did it take you to extract the necessary information?
+
+These points will help define the relevant data to be extracted and reach an agreement on doubts or conflicts. Thus, the instrument may be updated during the research to improve the sensitivity of evidence extraction [43].
+
+Selection
+
+The selection of studies will be based on the inclusion and exclusion criteria described above, as well as the research questions of this study. After selection, the articles used will be organized in the EndNote software, which will also identify possible duplicates [44]. The final sample of documents will be defined based on the critical reading of titles and abstracts by two independent reviewers (ISS and PBX), using the Rayyan software [45] for data organization, ensuring blinding of the reviewers, enabling the independent selection of evidence. In the event of conflicts in selection, these will be resolved by a third reviewer.
+
+During the full-text reading stage, researchers should also pay attention to the reference lists of included studies, as these can be an additional source. If any reference is found that meets the inclusion criteria, it may be included in the sample after its reading and critical analysis.
+
+Extraction of evidence
+
+Organization of the form
+
+An extraction form, available in Appendix 3 in S3 File, was developed by the authors, following the guidelines of Pollock and colleagues [42], adapted to the objective and research question of this review. Microsoft Excel® (version 17.0) will be used at this stage to organize the extraction of information in table format. The following information will be extracted from the final sample of included evidence: Principal author; Year of publication; Country/continent/region of publication; Type of study (primary research/evidence synthesis/discussion article/official document; quantitative/qualitative/mixed methods/grey literature); Objective; Digital tool/intervention; Technology; Website; Application; or other digital tool; Purpose of use (control, screening, monitoring, reminder, consultation, etc.); Did the use of digital health impact the quality of healthcare in PHC positively/negatively?; Language of publication; Which NCDs was described?; Were any Social Determinants of Health mentioned? If so, which ones?
+
+Analysis of evidence
+
+This review study will present both quantitative and qualitative results. Quantitative data will be evaluated through simple descriptive statistics (absolute frequencies and percentages) using Microsoft Excel® (version 17.0) [42]. The mapping results of the countries and regions identified that use digital health interventions in the care of people with NCDs will be organized and presented on a world map, showing the percentage of publications from each country/region/context, using the MapChart software.
+
+The qualitative data analysis will be guided by the theoretical framework of Peters and Pollock [42, 43], who recommend using basic qualitative content analysis in scoping reviews. Open coding will be adopted to allocate concepts or characteristics into general categories [42, 43]. Scoping review studies should be guided by the three phases of qualitative content analysis [42], described by Elo and Kyngäs [46], which are: i) preparation, ii) organization, and iii) reporting.
+
+The synthesis of evidence will be presented descriptively through tables, diagrams, and thematic maps for better visualization of the results [42]. A narrative summary will provide the mapped data and report how the results relate to the review’s objective and questions
+
+Presentation of results
+
+The final report of this study will be guided by PRISMA-ScR [32], presenting the results in the form of charts, figures, or flowcharts.
+
+Consultation with stakeholders
+
+Stakeholders is the term used, in plural, to refer to the interested parties in the development of health research. It is becoming increasingly common as researchers, journal editors, and funders recognize the potential impact they have on the evidence produced [47].
+
+During this stage, we will seek to share the preliminary results obtained, allowing stakeholders to understand and evaluate the uses and types of digital health tools used in the primary care of people with NCDs. Additionally, consulting with stakeholders will enable the authors to identify the best ways to disseminate the results and discuss how the study can help in the development of public health care policies [47]. In this way, we aim to encourage knowledge exchange, providing an opportunity to discuss new evidence or areas of research that may not have been addressed [30, 33]. In this research protocol, the sample of stakeholders will be intentionally selected using the snowball method, with 8 (eight) stakeholders: researcher (2), healthcare professional (2), technology developer (2), and people with NCDs (2), all with experience in the use of digital health aimed at primary care for people with NCDs.
+
+Presentation of results: Summary of evidence in relation to the review objective, drawing conclusions, and noting any implications of the results
+
+At this stage, a summary of the results related to the study objectives will be organized. Additionally, potential gaps will be identified based on the study results and stakeholder feedback, aiming to guide future studies on the topic. All the results and findings of the research will be presented in the scoping review that will be developed on the basis of this protocol. The results will be shared through a scientific article published in open access, and a summary of the main findings will be provided in dashboard format.
+
+Ethical aspects
+
+Although the scoping review does not require ethical approval, all ethical aspects for data analysis, stakeholder consultation, including the anonymity of the information shared, and data dissemination, will be duly evidenced and respected.
+
+Results
+
+The preparation of this protocol resulted in a complex and systematic search strategy, as recommended by PRISMA-ScR. The sample selection flow (Fig 1) shows the results obtained from different data sources, based on the search strategy proposed in this protocol. The complete flowchart containing all the stages of evidence synthesis will be available in the scoping review.
+
+10.1371/journal.pone.0316278.g001 Fig 1 Sample selection flowchart.
+
+Source: Prepared by the authors, 2024.
+
+Discussion
+
+Principal findings
+
+The development of this scoping review protocol contributes to defining the objective and research questions. By previously defining the inclusion and exclusion criteria, search methods and analysis strategy, the protocol minimizes the risk of bias in the selection of studies and the interpretation of results [48, 49].
+
+Technological and methodological advances in the management of NCDs indicate a significant shift towards personalized medicine and the integration of care [50]. Studies demonstrate the positive impact of digital technologies on patient education and the promotion of self-care, resulting in greater patient empowerment and better health management. This approach, however, needs to be implemented carefully so as not to alienate patients with low access to technological devices [51].
+
+Personalization of treatment is another key part of the findings, which argue that individualized management can lead to better outcomes. This suggests that healthcare professionals need to be willing to adapt their treatment plans according to the specific needs of each patient, a challenge that requires advanced clinical skills and adequate resources [50]. In addition, non-pharmacological interventions, such as physical exercise, should be considered essential components in the treatment strategy, as they can reduce dependence on medication and improve health outcomes [52].
+
+Although the findings are promising, there are significant limitations that need to be addressed. Most of the observed studies are focused on specific populations, limiting the generalizability of the findings to other demographic groups [53]. In addition, many studies have not fully assessed the challenges of implementing these strategies in resource-limited settings, such as rural areas or developing countries. However, the results provide a solid basis for the development of future studies that can explore personalized and integrated interventions more broadly [54].
+
+Thus, the construction of this manuscript is based on the need to guide a serious scoping review. This protocol strengthens the organization of the review process, transparency and replicability, defining clear steps and deadlines for compliance. This facilitates the management of time and resources, increasing the efficiency of the research team. In addition, scoping reviews with well-designed protocols contribute to the identification and synthesis of a wide range of evidence, providing a comprehensive view of a topic and identifying gaps in the existing literature [35, 49, 55].
+
+Limitations
+
+There are challenges typical of scoping reviews, such as the heterogeneity of the studies and difficulties in defining quality criteria. To minimize these, the inclusion and exclusion criteria have been rigorously defined. In addition, software will be used to identify duplicate texts, and a team of 3 researchers, specialized in the methodology and theme, will conduct the selection and analysis of the studies. Involving stakeholders in the presentation of results can be a challenge, as they may be biased in their interpretation of the results, placing more emphasis on one finding than another. To overcome this challenge, stakeholders will have access to the objective of the study, its methodology and its main findings, and guiding questions will guide the stakeholders’ assessment, preventing them from straying from the theme.
+
+Difficulties related to the object of study, digital health, arising from the variability in definition in the literature and capturing the complex interactions between technologies, health professionals and patients, were also addressed. To this end, a clear concept of digital health drawn up by the WHO was adopted, guiding and delimiting the themes of the studies to be selected. As a possible gap and possibility for future studies, it would be relevant to develop primary research that seeks to explore the use of digital health in different cultural contexts, applicability, health practices and community health realities around the world. Considering that the model linking structure, process and results makes it easier to identify the interface of technologies and analyze their impact on health. Recognizing that new studies may be published during the collection period, it is proposed that the searches be updated during the data extraction and analysis stage.
+
+Strengths
+
+This protocol stands out for its solid theoretical basis related to quality applied to digital health and for its methodology that follows scientifically validated guidelines. Consultation with stakeholders is a crucial point in guaranteeing the relevance, applicability and impact of the results. In this way, it helps to identify research priorities, understand the results in health management practice and indicate ways to effectively implement evidence-based interventions. The findings of the scoping review will present a comprehensive mapping of how ICTs can improve the quality of life of patients with NCDs, offering continuous and personalized support; identifying strategies to increase autonomy and self-management of chronic diseases by patients.
+
+Conclusion
+
+In summary, this scoping review protocol represents a significant effort to investigate the impact of digital technologies on the management of NCDs in PHC. This work presents a robust theoretical basis and rigorous methodology aligned with scientific guidelines, and is useful for conducting a review that explores and synthesizes a diverse corpus of evidence.
+
+The strategic inclusion of stakeholders will reinforce the relevance and applicability of the results, guiding health policies and clinical practices based on solid evidence. We recognize the inherent challenges, such as the heterogeneity of the studies and the issues in defining quality criteria, and we are committed to addressing them with methodological rigor.
+
+Supporting information
+
+S1 File Appendix 1.
+
+(PDF)
+
+S2 File Appendix 2.
+
+(PDF)
+
+S3 File Appendix 3.
+
+(PDF)
+
+S4 File Checklist_PRISMA-P.
+
+(PDF)
+
+We are grateful for the consulting services of the librarian Joyanne de Souza Medeiros.
+
+Abbreviations
+
+AI Artificial Intelligence
+
+BVS Virtual health library
+
+CAPES Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
+
+DeCS Health Sciences Descriptors
+
+ETD Electronic Theses and Dissertations
+
+ICTs Information and Communication Technologies
+
+JBI Joanna Briggs Institute
+
+MeSH Medical Subject Headings
+
+NCDs Chronic Non-Communicable Diseases
+
+OSF Open Science Framework
+
+PCC Population, Concept, and Context
+
+PHC Primary Health Care
+
+PRISMA-ScR Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews
+
+SDS Sustainable Development Goals
+
+WHO World Health Organization
+
+
+References
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Hum Resour Health
+Journal ID: Hum Resour Health
+NLM Journal ID: 101170535
+
+Human Resources for Health
+
+EISSN: 1478-4491
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11131235
+PMID: 38802822
+DOI: 10.1186/s12960-024-00912-1
+Article ID: 912
+Article version: 1
+Subjects: Research
+
+Developing a competency model for Chinese general practitioners: a mixed-methods study
+
+Gong Xue 1
+Zhang Xu 2
+Zhang Xinyan 3
+Li Yixuan 4
+Zhang Yang 5
+http://orcid.org/0000-0001-6892-8049 Yu Xiaosong xsyu@cmu.edu.cn
+4
+1 grid.412449.e 0000 0000 9678 1884 Library of China Medical University, Shenyang, China
+2 Department of Science and Education, Chaoyang Central Hospital, Chaoyang, China
+3 https://ror.org/008w1vb37 grid.440653.0 0000 0000 9588 091X School of Public Health, Jinzhou Medical University, Jinzhou, China
+4 https://ror.org/04wjghj95 grid.412636.4 Department of General Practice, the First Hospital of China Medical University, Shenyang, China
+5 grid.412449.e 0000 0000 9678 1884 Education Centre for Clinical Skills Practice of China Medical University, Shenyang, China
+Electronic publication date: 2024 May 27
+Publication date: 2024
+Volume: 22
+Electronic Location ID: 31
+Received 2023 Dec 27; Accepted 2024 May 16
+Copyright: © The Author(s) 2024
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: General practitioner, Competency, China, Assessment
+
+Funding: China National Medical Examination Centre 222‑2100019002 Yu Xiaosong
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2024
+
+Ÿ==============================Ÿ
+Background
+
+The Chinese government has formulated a series of policies and strengthened training of general practitioners (GPs) to support their role as “gatekeepers” of residents’ health. This study aimed to explore the core competencies of Chinese GPs and develop a competency framework in line with China’s actual conditions, which can provide a more scientific basis for the education, training, and evaluation of GPs.
+
+Methods
+
+Literature analysis and behaviour event interviews were conducted to build the competency dictionary and the initial version of the competency model. Two rounds of Delphi were performed to gain consensus on the final model. The questionnaire survey was carried out in 10 provinces (municipalities, autonomous regions) of China, and GPs were invited to score the importance of each competency item. The total sample was randomly divided into two groups. One group was for exploratory factor analysis (EFA), and the other was for confirmatory factor analysis (CFA) to examine the scale’s reliability and validity.
+
+Results
+
+The dictionary of general practitioners’ competency including 107 competency items was constructed. After two rounds of Delphi, a consensus was reached on 60 competencies in 6 domains. A total of 1917 valid questionnaires were obtained in the nationwide survey. The average importance score of all second-level indicators is 4.53 ± 0.45. The Cronbach’s α coefficient is 0.984. The results of the five factors extracted by EFA showing the 68.16% cumulative explained variance variation is considered to be consistent with the six dimensions obtained by Delphi after thorough discussion. The model fitness indexes obtained by CFA were acceptable (χ2/df = 4.909, CFI = 0.869, NFI = 0.841, RMSEA = 0.065). The values of the composite reliability (CR) of the six dimensions were all greater than 0.7 (0.943, 0.927, 0.937, 0.927, 0.943, 0.950), and the average of variance extracted (AVE) were all greater than 0.5 (0.562, 0.613, 0.649, 0.563, 0.626, 0.635). The results showed that the model has good reliability and validity.
+
+Conclusion
+
+A competency model for GPs suited to China has been developed, which may offer guidance for future training and medical licensing examinations of GPs.
+
+Introduction
+
+Health is a permanent goal pursued by the people. China is the world’s most populous country, and the Chinese government has consistently promoted the high-quality development of medical and health services and has given top priority to improving people’s health. Primary health care has received considerable attention in China since launching a new round of healthcare reform in 2009. The role of primary health care is further emphasised by the “Healthy China 2030 Planning Outline” approved in 2016 [1, 2]. General practitioners (GPs) are medical talents who have received a wide range of medical professional education and training and are often referred to as “health gatekeepers” [3]. As the leading providers of primary health care, sufficient and qualified GPs are critically important for primary health care to reach the goal of every citizen having equal access to affordable health care services. In 2011, the Chinese government formally launched its ambitious plan to establish a general practice system to reach at least two GPs per 10,000 population, a total of 300,000 GPs by 2020 [4]. To achieve this goal, the Chinese government has made many efforts. Government statistics show 2.9 GPs per 10,000 population in 2020 [5]. In 2018, the Chinese government announced a new plan of five GPs per 10,000 population, a net GP workforce of 700,000 GPs by 2030, an additional increase of 300,000 in a decade [6]. According to the survey results, less than 40% of GPs at the grassroots have bachelor’s degrees or higher degrees, and most GPs have not received standardised resident training [7]. Therefore, rapidly training more competent GPs has been regarded as an urgent problem [8]. Then, a fundamental issue that must be addressed is what kind of GPs are competent or what abilities a capable GP should have.
+
+Since the early 2000s, medical education has transformed traditional education into competency-based education [9]. More and more health systems and medical schools worldwide have adopted competency-based medical education [10–12]. The first step to implementing competency-based medical education is to define the competencies physicians should have. Some developed countries have identified the necessary competencies to be a qualified GP or family physician. The College of Family Physicians of Canada (CFPC) designed a competency framework CanMEDS-Family Medicine and described the roles and competencies required during Canadian family physicians’ work [13]. The Royal College of General Practitioners (RCGP) offered the GP curriculum based on the General Medical Council’s (GMC) generic professional capabilities framework and proposed five areas of capability and 13 specific capabilities for general practice [14]. The WONCA Europe released the European Definition of General Practice/Family Medicine 2023 edition, describing the core competencies required for GPs and family physicians [15]. The Accreditation Council for Graduate Medical Education (ACGME) Family Medicine Milestones arranged the elements of physician competencies into levels, and Milestones 2.0 was effective on July 1st, 2020 [16]. The competencies GPs need to possess and the training modes of GPs vary from country to country as they are affected by local, political, social, and economic circumstances. However, so far, China has not yet established a national-level competency evaluation system for GPs that adapts to China’s national conditions. On January 18th, 2018, the National Health Commission of China released the file “National Physician Qualification Examination Development Plan 2018–2020” and put forward two main tasks: researching GPs’ competencies and formulating competency-oriented admittance standards and examination syllabus, respectively. Thus, a set of core competencies suitable for Chinese GPs is expected to be developed.
+
+Methods
+
+This study was conducted from January 2019 to August 2021. The general competency model for Chinese GPs was developed in three phases: building the competency dictionary, constructing the competency model, and validating the model. Figure 1 shows the technological flow of our research.Fig.1 Methodological steps used in this study
+
+Phase I: building the GPs’ competency dictionary
+
+In the first phase, the methods of literature analysis and behaviour event interviews were used to collect the competency elements and construct the dictionary. The literature was mainly from policy documents, established competency models of GPs from other countries, and bibliography databases. The development direction and trend for GPs’ careers and the abilities required for GPs in China were clarified by interpreting the Chinese policy documents concerning GPs in detail. Mature competency models from other countries were obtained by searching their official websites. We collected the literature from five databases (PubMed, Thomson Reuters Web of Science Core Collection, China National Knowledge Infrastructure, and Wanfang Data) from 2000 to 2018. The search strategies in PubMed and Web of Science were as follows:
+
+PubMed: (general practitioner[mesh] OR family physician[mesh]) AND (competency[tiab] OR competence[tiab] OR competencies[tiab] OR ability[tiab] OR abilities[tiab] OR capability[tiab] OR capabilities[tiab] OR capacity[tiab] OR capacities[tiab] OR skill OR skills).
+
+Web of Science: TS = (general practitioner OR family physician OR family doctor) AND TS = (competency OR competence OR competencies).
+
+Behaviour event interviews (BEIs) were conducted with 22 GPs from different regions of China who had engaged in general practice-related work for five or more years. Half of the GPs were assigned to the high-achievement group, and the other half were in the low-achievement group. High achievers were individuals who had been awarded the national honour or won the national prize in general practice by the end of June 2019. Low achievers were defined as individuals who had not received any national award.
+
+The interviews were semi-structured. The first part is to obtain basic information about the interviewees, such as their routine work. The second part is to collect the most impressive and regretful events during their work and their feelings. The last question asks the interviewees to summarise the competencies they consider necessary for GPs. The interviews were kept under approximately 50 min long. After the interview, two research group members transcribed the recording word by word in a unified format in time. Then, they extracted the competency elements from the text according to the competency dictionary compiled in the previous step.
+
+Phase II: establishing the competency model
+
+In the second phase, the Delphi technique was adopted to revise the preliminary model and determine the final model. The selection of experts is the key to the successful implementation of Delphi. The experts in this study are required to meet the following conditions: (1) they have long engaged in general practice-related clinical, teaching, or administrative work and have a complete understanding of the development of general practice in China and other countries; (2) most of the experts are current or former members of the General Practice Branch of Chinese Medical Association or other national associations; (3) more experts from the Eastern region of China are selected due to the rapid development of general practice service; (4) they are willing to attend this research. We used email or WeChat to communicate with experts. The Delphi questionnaire was created based on the preliminary model. Experts were asked to rate the importance of competencies on a five-point Likert scale where 1 = “not important at all” and 5 = “very important”. The space was provided for experts to write their suggestions or opinions, such as adding new items. After the questionnaires were returned, we calculated the arithmetic mean, full score ratio, and coefficient variations (CV) of indicators based on expert scores and modified the indicators according to experts’ suggestions. The items with arithmetic mean ≥ 4.00, full score ratio ≥ 0.3, or CV ≤ 0.25 were considered more important and acceptable for entering the next steps in this research. Based on the results of the first round, the next round of consultation was conducted. This survey stopped until experts had consistent attitudes.
+
+Phase III: validating the competency model
+
+At this stage, a cross-sectional survey was conducted. We recruited Chinese GPs from different-grade medical establishments. All the participants gave written informed consent. They could withdraw from the study at any time and refuse to answer questions for any reason.
+
+The sample size for reliability and validity evaluation was 5–10 times the number of items [17, 18]. Considering some responses might be invalid, 20% of extra questionnaires were added. Thus, a minimum sample size of 660 was necessary for reliable results, as the preliminary instrument has 60 items.
+
+The stratified and convenient sampling methods ensured the sample was representative. This survey was conducted in 10 provinces (autonomous regions and municipalities directly under the Central Government) of China in the Northeast (Jilin, Liaoning), Eastern (Beijing, Shanghai, Jiangsu, Guangdong), Central (Shanxi, Henan), and Western (Guizhou, Shanxi). The surveyors received training to ensure they understood the questionnaire well.
+
+The sample was divided into two random subsamples to prove the factor validity. Exploratory factor analysis (EFA) by principal component analysis applied to the first half of the sample was used to explore the structure and extract common factors of the competency model. The Kaiser–Meyer–Olkin (KMO) and Bartlett’s sphericity test were studied for the suitability of the sample. The selection of factors mainly depends on Kaiser’s rule that whether they had eigenvalues greater than one [19]. Items loaded above 0.35 to the factors were considered valid. Confirmatory factor analysis (CFA) was performed in the second half of the sample to test the accuracy of the composition of each dimension and the fitting degree between the model and the actual survey data obtained from the EFA [20]. Some indices were obtained for assessing the model fitting degree, such as Chi-square (χ2)/degrees of freedom (df), comparative fit index (CFI), root-mean-square error of approximation (RMSEA), and normed fit index (NFI). Cronbach’s alpha was calculated for all common factors and dimensions to assess the scale’s internal consistency. The values of composite reliability (CR) and the average of variance extracted (AVE) were also calculated to test the convergent validity.
+
+Data were input with Epidata software version 3.0 and analysed with IBM SPSS Statistics version 23.0 for EFA and AMOS version 24.0 for CFA.
+
+Results
+
+Analysis of literature and BEIs
+
+In the first stage, with the search expression, 1493 articles from China National Knowledge Infrastructure, 677 from Wanfang Data, 1668 from PubMed, and 1752 from Web of Science. Twenty-two GPs participated in the interviews. Combined with the results of literature analysis and BEIs, a competency dictionary containing 107 items was finally built. Then, a preliminary competency model for Chinese GPs composed of 6 dimensions (first-level abilities) and 80 items (second-level abilities) was conducted after discussion. The six dimensions were: (a) basic medical services, (b) public health services, (c) information and management ability, (d) medical knowledge and lifelong learning, (e) interpersonal communication and teamwork, and (f) professionalism and personal characteristics.
+
+Results of two rounds of Delphi
+
+Two rounds of the Delphi consultation were carried out with 39 experts from general practice, health management, and medical education. They all had the senior professional title. Of the 39 experts, 37 had served or served in the official general practice associations.
+
+A total of 42 questionnaires were sent out, 39 valid questionnaires were recovered, and the effective recovery rate was 92.86% in the first round of consultation. Questionnaires for the second round were distributed to experts who responded to the first round. Thirty-five valid questionnaires were collected, with an effective rate of 89.74%. The arithmetic means of 79 (91.86%) competency items were higher than 4, 84 (97.67%) items had a full score ratio higher than 0.30, and the CV of 78 (90.70%) items were lower than 0.25 in the first round. Only 4 (5.80%) items had arithmetic means lower than 4, 5 (7.25%) had a lower full score ratio than 0.3, and 63 (91.30%) had CVs lower than 0.25.
+
+Competencies are defined as work-related knowledge, skills, traits, and motives. After two rounds of Delphi consultation, the competency model comprised six dimensions and 60 items (Table 1). Dimensions A to F were named basic medical services, basic public health services, information utilisation ability and management ability, medical knowledge and lifelong learning, interpersonal communication and teamwork, and professionalism, respectively.Table 1 The competency framework for Chinese GPs and importance score by GPs
+
+Dimensions	Items	Importance score (X ± S)	
+A. Basic medical services	A_1 Have general practitioners′ clinical thinking	4.56 ± 0.60	
+A_2 Collect medical history thoroughly and accurately	4.66 ± 0.53	
+A_3 Perform standardised physical examination and pay attention to mental state	4.66 ± 0.53	
+A_4 Write the medical documents following the standardisation	4.66 ± 0.54	
+A_5 Select the laboratory examination properly and interpret the results correctly	4.65 ± 0.56	
+A_6 Be proficient in basic diagnostic procedures	4.65 ± 0.54	
+A_7 Be able to diagnose and treat common diseases in communities	4.68 ± 0.53	
+A_8 Master first-aid skills	4.65 ± 0.57	
+A_9 Identify the patients at acute, severe stages and refer them promptly	4.69 ± 0.53	
+A_10 Manage chronic non-communicable diseases and follow up with the patients	4.60 ± 0.58	
+A_11 Provide the family-based services	4.47 ± 0.67	
+A_12 Use drug rationally	4.68 ± 0.54	
+A_13 Participate in hospice care	4.48 ± 0.66	
+B. Basic public health services	B_1 Be familiar with the knowledge and process of prevention and control of common infectious disease	4.57 ± 0.59	
+B_2 Organize community health education	4.50 ± 0.61	
+B_3 Offer common psychological consult	4.39 ± 0.72	
+B_4 Manage the particular population in the community	4.49 ± 0.63	
+B_5 Assist in handling public health emergencies	4.58 ± 0.58	
+B_6 Provide community rehabilitation services	4.46 ± 0.66	
+B_7 Promote pre-natal and post-natal care	4.39 ± 0.72	
+B_8 carry out the diagnosis of the community health state	4.47 ± 0.65	
+C. Information utilisation ability and management ability	C_1 Be able to retrieve and analyse medical literature	4.36 ± 0.71	
+C_2 Apply information technology effectively	4.43 ± 0.67	
+C_3 Establish and maintain resident health records	4.47 ± 0.65	
+C_4 Understand healthcare policy	4.46 ± 0.65	
+C_5 Know about the local cultural background	4.28 ± 0.78	
+C_6 Control the patients’ medical expenses scientifically	4.48 ± 0.64	
+C_7 Use the limited healthcare resources reasonably	4.49 ± 0.63	
+C_8 Possess some teaching ability	4.38 ± 0.72	
+D. Medical knowledge and lifelong learning	D_1 Master the basic medical knowledge	4.67 ± 0.54	
+D_2 Master the clinical medical knowledge	4.69 ± 0.51	
+D_3 Be familiar with the knowledge of epidemiology and medical statistics	4.50 ± 0.66	
+D_4 Be familiar with the knowledge of evidence-based medicine	4.49 ± 0.67	
+D_5 Be familiar with some medical humanities knowledge	4.46 ± 0.67	
+D_6 Master one foreign language at least	4.13 ± 0.96	
+D_7 Participate in continuing medical education and training projects actively	4.58 ± 0.61	
+D_8 Have the ability of creative thinking	4.45 ± 0.67	
+D_9 Have critical thinking skills	4.41 ± 0.72	
+D_10 Write and publish scientific research papers actively	4.13 ± 0.93	
+E. Interpersonal communication and teamwork	E_1 Establish a mutually trusted, lasting, and stable doctor–patient relationship	4.58 ± 0.58	
+E_2 Respect the local customs of patients	4.47 ± 0.66	
+E_3 Protect patient privacy and right to know	4.61 ± 0.58	
+E_4 Deal with ethical problems properly	4.55 ± 0.59	
+E_5 Prevent and resolve conflicts between doctors and patients	4.61 ± 0.56	
+E_6 Convey bad news to patients skillfully	4.49 ± 0.68	
+E_7 Make decisions together with patients and their families	4.53 ± 0.62	
+E_8 Explain medical information in an easily understandable way	4.59 ± 0.58	
+E_9 Work in harmony with colleagues	4.62 ± 0.55	
+E_10 Work with other teams effectively	4.61 ± 0.55	
+F. Professionalism	F_1 Abide the medical rules and regulations strictly	4.66 ± 0.52	
+F_2 Have the awareness of basic services	4.60 ± 0.56	
+F_3 Be self-sacrificing	4.54 ± 0.61	
+F_4 Make good career planning	4.53 ± 0.61	
+F_5 Have confidence and objective self-evaluation	4.51 ± 0.62	
+F_6 Be loving, sympathetic, and empathetic to patients	4.61 ± 0.54	
+F_7 Have the ability to insight	4.60 ± 0.55	
+F_8 Have patience and good psychological regulating ability	4.61 ± 0.54	
+F_9 Provide fair medical care services	4.60 ± 0.57	
+F_10 Wear in good taste fit to doctors’ identity	4.54 ± 0.59	
+F_11 Be achievement-oriented in daily work	4.54 ± 0.60	
+
+Results of the reliability and validity of the scale
+
+In total, 2126 questionnaires were gathered, and 1917 were considered valid (90.17%) in the third phase. The quantity meets the basic requirements for the required sample size. Among the effective respondents, 677 were males and 1240 were females. The demographic characteristics of the GPs participating in this survey are shown in Table 2.Table 2 Demographic characteristics of the GPs in this survey
+
+Characteristic	Category	Frequency	Percent (%)	
+Gender	Male	677	35.32	
+Female	1240	64.68	
+Working units	Community health centre	1200	62.60	
+Secondary hospital	67	3.50	
+Tertiary hospital	365	19.04	
+Township health centre	285	14.86	
+Professional titles	Primary	639	33.33	
+Middle	766	39.96	
+Vice-senior	347	18.10	
+Senior	95	4.96	
+No professional title	70	3.65	
+Education qualification	Junior college and below	259	13.51	
+Bachelor	1294	67.51	
+Master	325	16.95	
+Doctor	39	2.03	
+Region	Northeast China	454	23.68	
+Eastern China	798	41.63	
+Central China	374	19.51	
+Western China	291	15.18	
+
+The values of the Cronbach’s alpha for the full scale were 0.984, 0.946 for Dimension A, 0.927 for Dimension B, 0.935 for Dimension C, 0.920 for Dimension D, 0.946 for Dimension E, and 0.955 for Dimension F, demonstrating strong internal consistency.
+
+The results of the questionnaire survey show that the average importance score is 4.53 ± 0.45. The average score of each second-level indicator is above 4 (Table 1). According to the scale level, the importance level is “important”, indicating that the indicators were approved by the GPs participating in this survey. In overall ranking, the top three are “A_9 Identify the patients at acute, severe stages and refer them promptly”, “D_2 Master the clinical medical knowledge”, and “A_7 Be able to diagnose and treat common diseases in communities”. “D_6 Master one foreign language at least” and “D_10 Write and publish scientific research papers actively” ranked last.
+
+EFA was performed with the first half of the sample (N = 979). The KMO value was 0.982, sufficient to indicate a strong relationship [21]. Bartlett’s sphericity test, χ2 = 57,014.459, df = 1770, and p < 0.001, showed that the data were suitable for EFA. The eigenvalues were set to be greater than 0.35 when EFA was performed. After principal component extraction, five factors with initial eigenvalues greater than one were obtained, accounting for 68.14% of the overall variances. According to the rotated component matrix results, the items in Dimension A were all concentrated in the second factor, and items in Dimension B were focused on the third factor. Items in Dimension C, except C_3 and C_7, were concentrated in the fourth factor. Four items (D_1、D_2、D_3、D_4) of Dimension D focus on the fifth factor, and five (D_5、D_6、D_8、D_9、D_10) in the fourth factor. Items in E and F were concentrated in the first factor (Table 3).Table 3 Exploratory factor analysis loadings in sample 1 (N = 979)
+
+Items	Factors	
+1	2	3	4	5	
+A_1		0.609				
+A_2		0.716				
+A_3		0.725				
+A_4		0.747				
+A_5		0.754				
+A_6		0.759				
+A_7		0.794				
+A_8		0.685				
+A_9		0.746				
+A_10		0.616				
+A_11		0.467				
+A_12		0.723				
+A_13		0.483				
+B_1			0.520			
+B_2			0.661			
+B_3			0.671			
+B_4			0.654			
+B_5			0.606			
+B_6			0.609			
+B_7			0.676			
+B_8			0.673			
+C_1				0.548		
+C_2				0.455		
+C_3			0.612			
+C_4				0.367		
+C_5				0.545		
+C_6				0.369		
+C_7			0.449			
+C_8				0.494		
+D_1					0.655	
+D_2					0.653	
+D_3					0.454	
+D_4					0.389	
+D_5				0.572		
+D_6				0.795		
+D_7	0.526					
+D_8				0.538		
+D_9				0.643		
+D_10				0.759		
+E_1	0.677					
+E_2	0.600					
+E_3	0.641					
+E_4	0.660					
+E_5	0.699					
+E_6	0.619					
+E_7	0.635					
+E_8	0.686					
+E_9	0.745					
+E_10	0.710					
+F_1	0.649					
+F_2	0.692					
+F_3	0.719					
+F_4	0.666					
+F_5	0.698					
+F_6	0.707					
+F_7	0.716					
+F_8	0.716					
+F_9	0.716					
+F_10	0.672					
+F_11	0.670					
+
+The CFA was done with the second half of the sample (N = 938). The result is shown in Table 4, all within the range of acceptance or ideal, indicating that the results fit well with the 6-factor of the scale.Table 4 Fit indices for CFA of the competency model
+
+	χ2/df	CFI	GFI	NFI	RMSEA	
+Ideal	≤ 3	≥ 0.9	≥ 0.9	≥ 0.9	≤ 0.08	
+Acceptable	≤ 5	≥ 0.8	≥ 0.8	≥ 0.8	≤ 0.1	
+Result of the study	4.909	0.869	0.725	0.841	0.065	
+
+The CR of the six dimensions were 0.943, 0.927, 0.937, 0.927, 0.943, and 0.950, all greater than 0.7, and the AVE were 0.562, 0.613, 0.649, 0.563, 0.626, and 0.635, respectively, all greater than 0.5, showing the scale had good convergence validity [22].
+
+Discussion
+
+In the twenty-first century, the third wave of medical education reform with competency as the core has been set off around the world, and the reform of training medical talents has been gradually deepened in China. The competency model is an essential reference for designing, implementing, and evaluating competency-based programmes [23]. Compared with some developed countries, China has no national-level competency models for general practitioners, and research in this area is still at the primary stage. For this reason, an available model of the competencies required for Chinese GPs was constructed in this study.
+
+The choice of methods is of primal importance for constructing the competency model. Our study employed quantitative and qualitative methods, including literature analysis, BEIs, Delphi, and questionnaire surveys. These methods supplement and verify each other, ensuring the results’ reliability, accuracy, and comprehension [24]. Through literature analysis, competency items were extracted as the basis for the competency dictionary. BEIs are considered the most scientifically rigorous approach for identifying competencies and are commonly used in many fields for competency studies [25]. The front-line GPs’ perception of the knowledge, skills, and attitudes required within the context of general practice had been explored by BEIs. The Delphi method is a structured and commonly used technique in health professions to collect and screen expert advice and develop a framework for competency [26, 27]. The selection of the expert panel may limit the generalisability of the study. The Delphi panel usually consists of 15–30 experts [28]. A widely representative group of 39 Chinese and international medical experts involved in general practice participated in this study.
+
+EFA and CFA were used to verify the model of competencies. The results of EFA that five common factors were extracted, accounting for 68.16% of the variances, differed from that of Delphi, in which six factors were obtained. On this issue, experts in the field of general practice and medical statistics in our group believed that the items under the four dimensions of basic medical services, basic public health services, information utilisation ability and management ability, medical knowledge, and lifelong learning mainly were the same as the results from Delphi. The items in the other two dimensions of interpersonal communication and teamwork, and professionalism are mixed into one group, and most of the items are the competencies hidden or beneath the surface, according to the Iceberg Model. Our group believed that the six-dimensional framework constructed by Delphi was more explicit than that of the five common factors and more helpful for comparing different models. The results obtained from CFA have reached their respective defined values, indicating this indicator system has good reliability and validity. The results of the importance score showed that the competency model was widely accepted by the GPs participating in this survey from ten Chinese provinces.
+
+A competency model for Chinese GPs has been successfully built based on the abovementioned methods. The model is a multi-dimensional system comprising 60 competencies, structured into six dimensions: basic medical services, basic public health services, information utilisation ability and management ability, medical knowledge and lifelong learning, interpersonal communication and teamwork, and professionalism, respectively.
+
+The first dimension was named basic medical services, on which 13 items were loaded. Although GPs who provide comprehensive and continuous healthcare at the grass-roots level are considered a new type of clinician, their primary and most important role is still that of clinicians [29, 30]. GPs must master basic clinical skills such as collecting medical history and performing physical examinations. The second dimension consisted of 8 items, focusing on the capabilities of basic public health services. GPs are usually the first point of contact with the community and are critical to any public health crisis response [31]. During the COVID-19 pandemic, GPs in China are at the epidemic’s frontline [32]. GPs play an important role in detecting, reporting, and treating suspected and infected patients early. Some experts proposed that medical colleges should incorporate public health thinking into the training of GPs and integrate public health ability into the core abilities of GPs.
+
+The third dimension contained eight items, emphasising the ability of management and information utilisation. Information technology has infiltrated all areas of our lives, studies, and work, as well as the healthcare field [33]. Learning about information technology and developing the competencies of medical information retrieval and utilisation can help GPs better carry out clinical work and scientific research. GPs’ work involves the health management of individuals, families, and communities, so they also need specific management skills. The fourth dimension included ten items, concentrating on medical knowledge and lifelong learning. Sufficient preclinical and clinical medical knowledge is the foundation for providing medical and health services to patients and community residents. With the development of modern medical science, new knowledge and new technology emerge rapidly and continuously. All doctors, including GPs, should possess the ability of lifelong learning to keep up their knowledge and skill sets to deliver excellent patient care [34].
+
+The fifth dimension, interpersonal communication and teamwork, comprised ten items. GPs must effectively communicate and cooperate with patients, their families, and other health professionals. It has reached a consensus among GPs that gaining the trust of residents, patients, and their families and establishing a long-term, stable, cooperative relationship with them is critical to the success of general practice. The sixth dimension is related to professionalism with 11 items. As an invisible feature in the Iceberg model, professionalism has a decisive impact on the competency of GPs. Because of the particularity of medical work, doctors not only need to possess excellent professional and technical skills, but also good professional ethics and literacy.
+
+Comparing the model in our study with those from other countries, it is found that many of the domains and competencies are similar. Basic medical services, medical knowledge, lifelong learning, interpersonal communication, and teamwork are mentioned in the framework, such as the CanMEDS-FM, WONCA tree, and the Family Medicine Milestones with some different expressions. This may be due to the common nature of GPs worldwide, especially concerning the core competencies required of a qualified GP, irrespective of nationality. However, some differences exist between this Chinese GPs’ model and the others. In China, GPs are required to provide basic public health services. In contrast, public health physicians may carry out this work in the primary healthcare teams or by commercial operations in other countries. Lu et al. developed a competency model for GPs after standardised residency training in China [35]. The research ability was set as a primary indicator, which differed from our study.
+
+The services provided by GPs vary from country to country. In China, GPs primarily work in community and township health centres, diagnosing and treating common diseases, managing chronic diseases, providing health education, and performing other related tasks. However, due to inadequate staffing and poor teamwork, GPs are also expected to undertake public health and management work. Therefore, GPs must possess basic medical and public health services abilities and other competencies outlined in our competency model. In recent years, some secondary and tertiary general hospitals in China have established departments of general practice to teach and train GPs. GPs in these hospitals require specific teaching and research abilities, and scientific research ability is considered a secondary-level item in this general competency model for all GPs.
+
+There are some limitations of the study. During the national survey process, only GPs were investigated. A larger and broader pool of participants with various roles and experiences, such as patients and community residents, could be selected for further validation evidence. It is also important to highlight that the model is dynamic since the nature of any job role changes over time, given the society’s development and changes. Future research should involve re-assessment of the model over time based on such changes and the impact on the job role [36].
+
+Conclusion
+
+Our study constructed a general competency model for Chinese GPs that was validated to be reliable. The Chinese GPs’ competency framework includes six dimensions: (a) basic medical services, (b) basic public health services, (c) information utilisation ability and management ability, (d) medical knowledge and lifelong learning, (e) interpersonal communication and teamwork and (f) professionalism. This model is consistent with China’s current situation and will provide a good foundation for further training and evaluation of general practitioners in China.
+
+Abbreviations
+
+ACGME Accreditation Council for Graduate Medical Education
+
+AVE Average of variance extracted
+
+BEIs Behaviour event interviews
+
+CFA Confirmatory factor analysis
+
+CFI Comparative fit index
+
+CFPC College of Family Physicians of Canada
+
+CR Composite reliability
+
+CV Coefficient variations
+
+EFA Exploratory factor analysis
+
+GMC General Medical Council
+
+KMO Kaiser–Meyer–Olkin
+
+NFI Normed fit index
+
+RCGP The Royal College of General Practitioners
+
+RMSEA The root-mean-square error of approximation
+
+Acknowledgements
+
+We thank all experts and general practitioners who participated in this study for their support and valuable opinions.
+
+Author contributions
+
+YX conceived the study. GX, ZX, ZX, LY, and ZY conducted the investigation and collected the data. GX, ZX2, and ZY performed the statistical analysis. GX and YX drafted and revised the manuscript. All authors have approved the final version of the manuscript.
+
+Funding
+
+This study was financed by the China National Medical Examination Centre.
+
+Availability of data and materials
+
+The datasets used during the current study are available from the corresponding author upon reasonable request.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Ethics approval was granted by the China Medical University Review Board.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare that they have no competing interests.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+2. Li X Lu J Hu S Cheng KK Maeseneer JD Meng Q The primary health-care system in China Lancet 2017 390 10112 2584 2594 10.1016/S0140-6736(17)33109-4 29231837
+3. Sato K Michinobu R Kusaba T Mixed methods study protocol to examine perceptions of family medicine among long-term patients of a family medicine clinic in Japan BMJ Open 2020 10 9 e037113 10.1136/bmjopen-2020-037113 32973059 PMC7517553
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+5. National Health Commission of the People’s Republic of China. Statistical Bulletin on the Development of Health Care (2020). http://www.nhc.gov.cn/guihuaxxs/s10743/202107/af8a9c98453c4d9593e07895ae0493c8.shtml. Accessed 20 November 2023.
+6. Chen Q Lian S Plegue MA Fetters MD First-year medical student attitudes about general practice in China: a comparison between Chinese and international students Adv Med Educ Pract 2019 10 571 579 10.2147/AMEP.S198877 31551660 PMC6677372
+7. Wu N Cheng MY Yan LN Qian WY Zhang GP Training development report of GPs (2018) Chin General Pract 2018 21 10 1135 1142
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+9. Guerrero APS Beresin EV Balon R Brenner AM Louie AK Coverdale JH The competency movement in psychiatric education Acad Psychiatry 2017 41 3 312 314 10.1007/s40596-017-0712-6 28382588
+10. Frenk J Chen L Bhutta ZA Cohen J Crisp N Evans T Health professionals for a new century: transforming education to strengthen health systems in an interdependent world Lancet 2010 376 9756 1923 1958 10.1016/S0140-6736(10)61854-5 21112623
+11. Lucey CR Thibault GE Ten Cate O Competency-based, time-variable education in the health professions: crossroads Acad Med 2018 93 S1 S5 10.1097/ACM.0000000000002080 29485479
+12. Meilianti S Smith F Bader L Himawan R Bates I Competency-based education: developing an advanced competency framework for Indonesian pharmacists Front Med (Lausanne) 2021 8 769326 10.3389/fmed.2021.769326 34901084 PMC8655862
+13. Shaw E, Oandasan I, Fowler N. CanMEDS-FM 2017: A competency framework for family physicians across the continuum. Mississauga, ON: The College of Family Physicians of Canada. 2017.
+14. Royal College of General Practitioners. GP curriculum: Being a general practitioner. https://www.rcgp.org.uk/mrcgp-exams/gp-curriculum/being-general-practitioner. Accessed 20 November 2023.
+15. Wonca Europe. The European Definition of GP/FM. https://www.woncaeurope.org/page/definition-of-general-practice-family-medicine. Accessed 20 November 2023.
+16. The Accreditation Council for Graduate Medical Education. Family Medicine Milestones. https://www.acgme.org/globalassets/pdfs/milestones/familymedicinemilestones.pdf. Accessed 20 November 2023.
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+18. Mei N Chang L Zhu Z Dong M Zhang M Zeng L Core competency scale for operating room nurses in China: scale development, reliability and validity evaluation Nurs Open 2022 9 6 2814 2825 10.1002/nop2.985 34247455 PMC9584484
+19. Courtney MGR Gordon M Determining the number of factors to retain in EFA: using the SPSS R-Menu v20 to make more judicious estimations Pract Assessment Res Eval 2013 18 8 1 14
+20. Kamaruzzaman S Ploubidis GB Fletcher A Ebrahim S A reliable measure of frailty for a community dwelling older population Health Qual Life Outcomes 2010 8 123 10.1186/1477-7525-8-123 21029450 PMC2988728
+21. Leng J Tao M Huai J Fan Z Test of reliability and validity of impulsiveness scale among married Chinese Psychol Res Behav Manag 2022 15 903 912 10.2147/PRBM.S360854 35463938 PMC9018674
+22. Harmoinen M Niiranen V Munnukka J Suominen T Reliability and validity of a further tested appreciative management scale J Nurs Meas 2021 29 1 66 79 10.1891/JNM-D-19-00047 33334846
+23. Liang JF Hsu TF Chen CY Yang CW Jean WH Ou LS Developing a competency-based framework for resident-as-teacher J Formos Med Assoc 2022 121 10 1956 1962 10.1016/j.jfma.2022.01.027 35151563
+24. Shi L Fan L Xiao H Chen Z Tong X Liu M Constructing a general competency model for Chinese public health physicians: a qualitative and quantitative study Eur J Public Health 2019 29 6 1184 1191 10.1093/eurpub/ckz048 30945732
+25. Getha-Taylor H Identifying collaborative competencies Rev Public Personnel Adm 2008 28 2 103 119
+26. Kilroy DA Mooney JS Determination of required pharmacological knowledge for clinical practice in emergency medicine using a modified Delphi technique Emerg Med J 2007 24 9 645 647 10.1136/emj.2007.050633 17711943 PMC2464646
+27. Bion JF Barrett H Development of core competencies for an international training programme in intensive care medicine Intensive Care Med 2006 32 9 1371 1383 10.1007/s00134-006-0215-5 16841214
+28. de Villiers MR de Villiers PJ Kent AP The Delphi technique in health sciences education research Med Teach 2005 27 7 639 643 10.1080/13611260500069947 16332558
+29. Hays R Gupta TS Developing a general practice workforce for the future Aust J Gen Pract 2018 47 8 502 505 10.31128/AJGP-02-18-4488 30114888
+30. Yang L Cheng J Analysis of inequality in the distribution of general practitioners in China: evidence from 2012 to 2018 Prim Health Care Res Dev 2022 23 e59 10.1017/S1463423622000408 36117274 PMC9532852
+31. Sotomayor-Castillo C Nahidi S Li C Hespe C Burns PL Shaban RZ General practitioners’ knowledge, preparedness, and experiences of managing COVID-19 in Australia Infect Dis Health 2021 26 3 166 172 10.1016/j.idh.2021.01.004 33676878 PMC7891055
+32. Yin Y Chu X Han X Cao Y Di H Zhang Y General practitioner trainees’ career perspectives after COVID-19: a qualitative study in China BMC Fam Pract 2021 22 1 18 10.1186/s12875-020-01364-x 33430776 PMC7797889
+33. Park AJ Maruther MK Swerlick RA Information technologies in health care delivery and policy: giant steps and missteps Semin Cutan Med Surg 2019 38 1 E25 E30 10.12788/j.sder.2019.005 31051020
+34. McAdams CD McNally MM Continuing medical education and lifelong learning Surg Clin North Am 2021 101 4 703 715 10.1016/j.suc.2021.05.015 34242611
+35. Wei Y Wang F Pan Z Wang M Jin G Liu Y Development of a competency model for general practitioners after standardized residency training in China by a modified Delphi method BMC Fam Pract 2021 22 1 171 10.1186/s12875-021-01508-7 34433420 PMC8390270
+36. Patterson F Ferguson E Lane P Farrell K Martlew J Wells A A competency model for general practice: implications for selection, training, and development Br J Gen Pract 2000 50 452 188 193 10750226 PMC1313648
diff --git a/corpus/healthcare/text/d6f7c26cd007f2e8.txt b/corpus/healthcare/text/d6f7c26cd007f2e8.txt
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@@ -0,0 +1,613 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMJ Open
+Journal ID: BMJ Open
+NLM Journal ID: 101552874
+Journal ID: bmjopen
+
+BMJ Open
+
+EISSN: 2044-6055
+Publisher: BMJ Publishing Group
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13288683
+PMID: 42331574
+DOI: 10.1136/bmjopen-2025-113940
+Article ID: bmjopen-2025-113940
+Article version: 1
+Subjects: Original Research, Public Health, 1724, 1506
+
+Implementing women’s sexual and reproductive health interventions in prisons: a realist review
+
+https://orcid.org/0009-0008-1836-8782 Rickard Joy 1
+Melendez-Torres G J 1
+1 University of Exeter , Exeter , UK
+Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
+
+None declared.
+
+Joy Rickard; jr884@exeter.ac.uk
+Publication date: 2026
+Electronic publication date: 2026 Jun 22
+Volume: 16
+Issue: 6
+Electronic Location ID: e113940
+Received 2025 Nov 18; Accepted 2026 Jun 3
+Copyright: Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.
+Copyright year: 2026
+License: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Prisons, Implementation Science, Mass Screening, PUBLIC HEALTH, Preventive Health Services, Sexually Transmitted Disease
+
+Ÿ==============================Ÿ
+Abstract
+
+Objectives
+
+To explore what works for whom, how and why when implementing women’s sexual and reproductive health interventions in prisons to understand the barriers and facilitators to implementation and to generate recommendations for policymakers.
+
+Design
+
+Realist review using the Realist And Meta-narrative Evidence Synthesis: Evolving Standards guidelines.
+
+Data sources
+
+We systematically searched Ovid MEDLINE, Global Health, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the American Psychological Association (APA) PsycINFO databases and hand-searched unpublished literature and reference lists, January–June 2025.
+
+Eligibility criteria for selecting studies
+
+Primary studies of implementing women’s sexual and/or reproductive health interventions, including those addressing sexually transmitted infections, cervical health, breast screening, contraception and women’s health holistically. Study populations included people in prisons that detain women in high-income countries.
+
+Data extraction and synthesis
+
+We extracted and analysed data relating to implementation processes using a grounded theory approach and retroductive inference to articulate cross-case Intervention-Context-Actor-Mechanism-Outcome configurations (ICAMOCs) and refine programme theory. We discussed findings in relation to existing theories from the literature to elicit recommendations for policymakers.
+
+Results
+
+Of 4617 deduplicated records, 26 met the inclusion criteria. Ten ICAMOCs were constructed from cross-case analyses, grouped into three themes: (1) planning (teaming, team leadership, assessing needs and capacity, tailoring and planning), (2) doing (piloting, standardisation and support, trauma-informed engagement and peer advocacy) and (3) sustaining (evaluation-adaptation cycles). The ICAMOCs indicated three overarching mechanisms as being key to effective implementation, namely, perceived utility of the intervention, motivation and empowerment.
+
+Conclusions
+
+For women’s sexual and reproductive health interventions to be effective in prisons, everyone involved in implementation needs to perceive the intervention’s benefit and be both motivated and empowered to take action. We recommend policymakers build a resilient and empowered delivery workforce, invest in research partnerships to increase awareness and understanding and promote trauma-informed approaches to women’s healthcare in prisons.
+
+STRENGTHS AND LIMITATIONS OF THIS STUDY
+
+Realist synthesis is well suited to evaluating the implementation of interventions in complex real-world settings such as prisons.
+
+The inclusion of studies from unpublished literature may lower publication bias but may also lack rigour.
+
+Only studies from high-income countries published in English since 2010 were included. Furthermore, the predominance of North American studies (n=19) may limit generalisability to England.
+
+While pragmatism is advised in realist reviews to balance theoretical saturation with the availability of studies and time, further purposive sampling could have been undertaken.
+
+Introduction
+
+Rationale
+
+It has been shown that people in prison are more likely to have complex needs and poorer health outcomes than the general population and that detention can have a harmful, ageing effect.15 Further evidence suggests this disparity may be greater for people in prisons that detain women (PPDW), who are at higher risk of worse outcomes and premature mortality.68 For example, when compared with people in prisons that detain men, substance misuse was found to be more prevalent, and rates of self-harm, attempted suicide and mental health conditions were higher.579 Further studies found higher prevalence of sexually transmitted infections (STIs), menstrual irregularities and amenorrhoea compared with the community and substantially higher rates of dysplasia and cervical cancer.910 1216 There is also evidence that cancers are diagnosed later and have lower overall survival in prison settings than in the community.2 17 18
+
+The wider determinants of health and crime are largely comparable, and people detained in prisons for women often encounter multiple disadvantages throughout life.1 2 5 6 They are more likely than other people in prison and those in the community to experience poverty, housing insecurity, unemployment, sexual/physical violence, commercial sex work, trafficking and multiple sexual partners.1 6 9 10 12 In England, one-third spent time in care, two-thirds survived domestic abuse and ethnic minorities are over-represented.2 5 6 It has been suggested that women’s sexual and reproductive health is under-represented in research and policymaking and that existing services can be fragmented and difficult to access for marginalised groups.19 20 People are therefore more likely to enter prison with low rates of screening and healthcare engagement, perpetuating a high-risk/low-uptake anticorrelation.22124 Such complex intersecting factors can lead to compound health inequalities and unmet needs for PPDW.5 25
+
+As sites of ‘dynamic exchange’26 (p. 239) with marginalised groups, prisons can provide opportunities for people to engage with public health interventions at least equivalent to those available in the community.6 10 23 27 It has been suggested this could reduce health inequalities and reoffending, with downstream benefits for the families, communities and health services people in prison return to on release.1 2 26 28 29 England’s Chief Medical Officer5 recommends the prioritisation of preventive health interventions in prisons, and there is growing international support for improved women’s sexual and reproductive health provision.6 30 However, more research in this field is needed.6 21 31 32 In England, only 1% of approved prison-based research projects conducted in 2015–2024 addressed reproductive and/or perinatal health.5 Internationally, we found very few systematic and scoping reviews of relevance, and those available describe multiple service gaps and inadequacies, particularly for contraception.153338 A recent National Health Service (NHS) England review found that, despite some examples of good practice, women’s sexual and reproductive health is systemically underserved in prisons.6 Improvements in cervical screening uptake, for example, have been shown to plateau considerably below national coverage and targets.24
+
+In contrast, there is good evidence that community-based women’s sexual and reproductive health interventions are effective.3943 However, the uptake and sustainability of complex interventions are highly context dependent, and implementation strategies used in other settings may not be transferable to prisons.44 45 Service reviews characterise England’s prison infrastructure as ‘ageing…designed for a young male population’5 (p. 10) and ‘unfit for purpose’6 (Section 2.10) for people detained in prisons for women, who constitute <5% of the population.46 The evidence suggests that high demand for urgent care can make overburdened, under-resourced health services reactive not proactive and post-pandemic recovery of screening services has been slow.1 17 47 Short sentences and geographical displacement may also limit the timeframe for action and present challenges for follow-up.6 33 To bridge the evidence-practice gap, there is a need to identify the conditions required for effective and sustainable operationalisation of women’s sexual and reproductive health interventions in the real-world settings of prisons.44 45 47
+
+Rationale for realist synthesis
+
+Complex public health interventions use strategies and resources to improve population health.48 49 However, in reality, they interact dynamically with the open social systems in which they are implemented, making outcomes uncertain.49 50 That is, multiple contextual factors determine the activation and intensity of multiple mechanisms, which determines the direction and magnitude of multiple outcomes.5153 So, an intervention’s impact may differ when implemented for, and by, different actors in a different time and space. This generative model of causality forms the philosophical basis for realist inquiry.49
+
+Where traditional systematic reviews focus on internal validity, realist methods are better suited to evaluating external validity by considering interventions within their delivery contexts to better understand facilitators and barriers along the implementation pathway and identify effective strategies to navigate them.454749 This is achieved through ‘retroductive theorising’, working backwards from observed outcomes to infer underlying causal mechanisms.5355 In realist synthesis, initial programme theories (IPT) provide high-level hypotheses of how interventions should work.54 56 57 Observations from primary studies are then used to form context-mechanism-outcome (CMO) configurations to test and refine the programme theory (PT).5659 Middle-range theories can both inform IPT and explain the PT, increasing external validity (see table 1 for key terms).54 59 Adopting this approach, the objective of this review was to provide post hoc, theory-based insights for policymakers into what works for whom, how and why when implementing women’s sexual and reproductive health interventions in prisons.45 47
+
+Table 1 Key concepts in realist reviews
+
+Concept	Definition	
+Explanatory factors	Intervention (I)	Any resources, strategies or activities used in the design, implementation or evaluation of an intervention.105107	
+Context (C)	The particular set of circumstances in which the intervention is implemented.61 106	
+Actor (A)	An individual, group or organisation involved in one or more aspects of the implementation.61 106	
+Mechanism (M)	An unseen power, force, response, feedback or interaction with the potential to cause an outcome.51 106	
+Outcome (O)	An intended or unintended consequence of the intervention.61	
+Theory	Initial programme theory (IPT)	Macro-level; a theory about how the intervention should work.56 57 108	
+Programme theory (PT)	Micro-level; theories about how and why interventions work; the conditions needed (C) to trigger mechanisms (M) to produce outcomes (O).49 56 59	
+Middle-range theory (MRT)	Macro-level; abstracted theories that explain the PT.54 59	
+
+Materials and methods
+
+This review is reported according to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES),58 guided by Pawson et al’s49 five steps, with adaptations drawn from the realist literature.
+
+Informal scoping of the literature by the lead author (JR), and discussion with the second author (GJMT), informed the IPT, the scope of the review and the search strategy.60 Next, JR conducted in-depth searches for primary studies and extracted data into Intervention-Context-Actor-Mechanism-Outcome configurations (ICAMOCs)—here, intervention (I) and actor (A) were added as explanatory factors to the CMO heuristic to differentiate intervention from context and specify the individuals/groups/institutions involved (see table 1).596163 Finally, JR discusses the PT to provide recommendations for policymakers.
+
+Scoping the literature
+
+JR conducted informal, exploratory searches of the literature to (a) identify relevant national and international policies and guidance to inform both the women’s sexual and reproductive health domains for inclusion and the IPT development and (b) scope the availability and nomenclature of primary studies to inform the search strategy.
+
+Women’s sexual and reproductive health domains
+
+Women’s health hubs (WHH) have been championed as a model for improving access to women’s health services in the community, including those on probation or community supervision.5 19 Therefore, we used the core services defined in the WHH core specification64 to identify women’s sexual and reproductive health domains for inclusion. We cross-referenced this with key policy and guidance documents to ensure relevance to England’s prison context.23 28 30 65 66 Pregnancy testing received multiple recommendations, so was added. Pessaries and preconception care were not mentioned, so were removed. Menopause was absent from prison recommendations but identified as an overlooked need in a recent NHS England review,6 so was retained. The final women’s sexual and reproductive health domains in scope for this review are shown in table 2.
+
+Table 2 Women’s sexual and reproductive health domains (those excluded are shown in italics)
+
+Women’s sexual and reproductive health domain	WHH64	NHS23	WHO28	NICE65	BASHH66	PRI30	
+STI/HIV (screening)	Yes	Yes	Yes	Yes	Yes	Yes	
+Cervical (screening)	Yes	Yes	Yes	Yes		Yes	
+Breast (screening)	Yes	Yes	Yes	Yes		Yes	
+Menstrual problems	Yes		Yes		Yes	Yes	
+Contraception	Yes		Yes		Yes		
+Pregnancy (testing)			Yes	Yes	Yes		
+Menopause	Yes						
+Preconception care	Yes						
+Pessary care	Yes						
+BASHH, British Association of Sexual Health and HIV; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PRI, Penal Reform International; STI, sexually transmitted infection; WHH, women’s health hubs.
+
+Initial programme theory
+
+The Consolidated Framework for Implementation Research (CFIR) is commonly used by implementation scientists to aid systematic analysis.67 We therefore formed a conceptual framework based on the five CFIR contextual domains (outer setting, inner setting, intervention, implementation process and actors), plus constructs from the CFIR implementation process domain (teaming, assessing needs/capacity, planning, tailoring, implementing, engaging, evaluating and adapting), modifying terms where appropriate to reflect realist terminology (table 1) and the sensitivity of the review topic. We supplemented this with Proctor et al’s68 implementation outcomes (appropriateness, acceptability, feasibility, adoption, integration/reach, fidelity, cost-effectiveness and sustainability) and contextual factors of relevance from the prison healthcare guidance documents identified in the initial scoping.6 23 28 30 65 66 This conceptual framework forms an IPT of how the implementation of women’s sexual and reproductive health interventions in prisons should work. We include a pictorial representation in online supplemental file 1.
+
+Searching process
+
+We developed and implemented the search strategy iteratively in January–June 2025, following realist principles.49 This included published and unpublished literature and used online searching and ‘snowballing’ citation searching methods. JR performed systematic searches of peer-reviewed journals using Ovid MEDLINE, Global Health, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the American Psychological Association (APA) PsycINFO databases to provide an appropriate spread of the indexed health research literature, including medical, public health and mental health research. Synonymous search terms identified through exploratory searches were aggregated, including multiple alternatives for prisons and people in prison (jail, detention, incarceration, remand, felon, etc) to reflect international and colloquial variations. Terms were combined with Boolean commands (AND/OR/NOT) and wildcard characters, using medical subject heading (MeSH) terms as appropriate (see online supplemental file 1 for full details). We limited searches to 2010 or later, as the United Nations adopted the ‘Bangkok Rules’30 for women’s prison healthcare in 2010. JR used EndNote to manage and deduplicate search results and Mendeley Cite to manage citations.
+
+Selection and appraisal of documents
+
+Informal searches highlighted a scarcity of England-based intervention studies, so all high-income countries were included.69 While significant heterogeneity was expected, limiting studies to high-income countries may increase generalisability to England’s prisons.
+
+JR deduplicated results and screened titles and abstracts against inclusion/exclusion criteria (see online supplemental file 1). In brief, interventions implemented in high-income country prisons addressing at least one women’s sexual and reproductive health domain (table 2) and delivered during detention were included. Adult women, people who identify as female and people of diverse gender assigned to be detained in a prison for women, were included (referred to throughout as PPDW). Studies that did not describe or evaluate implementation components, factors or outcomes or were unavailable in English were excluded. JR then conducted full-text screening, another reviewer (see Contributors) rescreened a 10% random sample and discrepancies in decisions were discussed and resolved.
+
+Aligning with realist methods,49 JR created a matrix (see table 3) to appraise records for relevance, richness and rigour, using a high-medium-low scale based on concepts described by Dada et al.70
+
+Table 3 Appraisal criteria, based on concepts described by Dada et al70
+
+Appraisal	High	Medium	Low	
+Relevance	Direct focus and/or good specificity	Single issue and/or some specificity	Indirect issue and/or little specificity	
+Richness	Rich description and/or explicit theory	Adequate description and/or little explicit theory	Weak description and/or no explicit theory	
+Rigour	Credible source and/or transparent	Potential bias and/or somewhat transparent	Clear bias and/or poor transparency	
+
+Data extraction
+
+JR created a Microsoft Excel matrix to capture summary information about included studies, comprising title, author, publication year, country, study type, gender, women’s sexual and reproductive health domain(s), brief description and appraisal rating. A second matrix captured Intervention-Context-Actor-Mechanism-Outcome configurations (ICAMOCs). Data extraction and coding were managed using Delve Tool software.71
+
+Data relating to implementation processes were extracted, but those relating to study processes were not. For example, eligibility identification for interventions was, but selection processes for trial participants were not. As England’s prison health services are free-at-point-of-care, factors relating to user fees were not extracted, although any wider implications were considered.
+
+Analysis and synthesis process
+
+JR analysed studies adopting a grounded theory approach. Potential explanatory factors were identified inductively through open coding, guided by—but not limited to—the IPT.72 Any convergence or divergence of outcomes was noted, and interventions reported in multiple studies were cross-referenced. Axial coding was then used to group and refine explanatory factors into case-specific ICAMOCs from which cross-case ICAMOCs were inductively and abductively inferred, and deductively tested, in an iterative process. Thus, working retroductively, causal relationships were articulated and discussed in relation to middle-range theories and the IPT to derive insights.
+
+Patient and public involvement
+
+No patients or members of the public were involved in the design, conduct, reporting or dissemination of this research.
+
+Results
+
+Document flow diagram
+
+Systematic searches identified 4637 deduplicated records, of which 4554 did not meet inclusion criteria. After full-text screening, a further 57 records were excluded, and 26 were included in this review. Figure 1 presents a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of the searching and selection process.
+
+Figure 1 Flow diagram of search results and the selection of records.
+
+Study characteristics
+
+Included studies represented five high-income countries: 17 from the USA,7389 three from Australia,9092 three from England,9395 two from Canada96 97 and one from Ireland.98 There were 12 evaluations,7374 76 78 79 85 87 90 9295 seven case studies,75 77 83 86 88 89 91 four quantitative,808284 two qualitative97 98 and one mixed methods.96 Overall, studies were of good quality; none were rated low against all criteria, while two were rated high against all criteria. Table 4 summarises the study characteristics.
+
+Table 4 Characteristics of included documents
+
+Author(s), title, year of publication	Study design	Health domain,
+country, gender	Intervention overview	Appraisal Rel-Ric-Rig	
+Against Violence and Abuse. An evaluation of Women in Prison’s Health Matters Project. 2019.93	Evaluation	Women’s health,
+England, F	Women’s health advocacy and health promotion programme.	H-H-L	
+Besney, et al Addressing Women’s Unmet Health Care Needs in a Canadian Remand Center: Catalyst for Improved Health? 2018.96	Mixed methods	Women’s health,
+Canada, F	Women’s health programme including testing, education and care.	H-M-H	
+Cocoros, et al Screening for Hepatitis C as a Prevention Enhancement (SHAPE) for HIV: An Integration Pilot Initiative in a Massachusetts County Correctional Facility. 2014.81	Quantitative	STI (HCV),
+USA, M/F	SHAPE HCV screening and education programme (adapted from an existing HIV intervention).	M-M-M	
+Cole, et al Opt-out screening for Chlamydia trachomatis and Neisseria gonorrhoeae in female detainees at Cook County jail in Cole et al (2014).82	Quantitative	STI,
+USA, F	Universal, opt-out STI screening programme on reception to prison.	H-M-H	
+Crowley, et al Hepatitis C virus screening and treatment in Irish prisons from nurse managers’ perspectives - a qualitative exploration. 2019.98	Qualitative	STI (HCV),
+Ireland, M/F	Barriers/facilitators to implementing HCV screening programmes.	L-H-H	
+Dang, et al Paired Testing of Sexually Transmitted Infections with Urine Pregnancy Tests in Incarcerated Women. 2021.80	Quantitative	STI, pregnancy,
+USA, F	Opt-out programme pairing STI screening with routine urine pregnancy testing.	H-L-H	
+Emerson, et al Barriers and facilitators of implementing a collaborative HPV vaccine program in an incarcerated population: A case study. 2020.77	Case study	STI (HPV),
+USA, M/F	Opt-in HPV vaccination programme in a prison population.	M-H-M	
+Fasula, et al Project POWER: adapting an evidence-based HIV/STI prevention intervention for incarcerated women. 2013.79	Evaluation	STI (inc. HIV),
+USA, F	Project POWER sexual health education programme (adapted from SAFE).	H-H-M	
+Harmon, et al Routine screening in a California jail: effect of local policy on identification of syphilis in a high-incidence area, 2016–2017. 2020.83	Case study	STI (syphilis),
+USA, F/M	Syphilis screening programme for targeted age groups.	M-M-H	
+Hesse, et al Cancer screening in prisons: lessons for health providers. 2022.91	Case study	Breast screening,
+Australia, M/F	Nurse-led programme to facilitate breast screening uptake in four prisons.	M-L-L	
+Holton, Hampton. Implementing High-Intensity, Trauma-Informed Sexual Risk Reduction in Women Involved in the Criminal Legal System. 2023.84	Quantitative	STI,
+USA, F	SSE high-intensity trauma-informed educational programme to reduce STI risk.	H-L-H	
+Johnson, et al Feasibility of an HIV/STI Risk-Reduction Program for Incarcerated Women Who Have Experienced Interpersonal Violence. 2014.85	Evaluation	STI (inc. HIV),
+USA, F	Women’s CoOp STI/HIV prevention programme for prisons (adapted from an existing intervention).	H-H-H	
+Kelly, et al Developing a Cancer Prevention Health Education Resource: A Primer of Process and Evaluation. 2020.76	Evaluation	Cancer screening,
+USA, F	Cervical and breast cancer education resource development.	L-H-M	
+Kennedy, et al Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants. 2023.75	Case study	Cervical screening,
+USA, F	SHE cervical cancer education programme. Post-detention elements were excluded.	M-M-H	
+McNeely, et al Expanding Contraceptive Access for Women with Substance Use Disorders: Partnerships McNeely et al (2019).87	Evaluation	Contraception,
+USA, F	Contraceptive programme including prison-based education and prison- or community-based LARC fitting.	H-M-M	
+Mongale, et al Development and optimisation of a reception testing protocol designed to eliminate HCV in the UK prison population. 2024.95	Evaluation	STI (HCV),
+England, M/F	HCV screening protocol.	M-M-M	
+Murphy, et al Implementing Preexposure Prophylaxis for HIV Murphy et al (2024).86	Case study	STI (HIV),
+USA, M/F	Pre-exposure prophylaxis programme for HIV prevention.	M-M-M	
+Pankow, et al Evaluating Fidelity to a Modified NIATx Process Improvement Pankow et al (2018).74	Evaluation	STI (HIV),
+USA, not stated	HIV-STIC protocol for implementing HIV education, testing and care interventions (adapted from NIATx).	H-H-H	
+Paynter, et al The experiences of family planning health professionals providing care to incarcerated patients: A qualitative study. 2025.97	Qualitative	Contraception,
+Canada, F	Barriers/facilitators to contraceptive services for PPDW. Elements relating to abortion were excluded.	L-H-H	
+Phaw, et al Prospective evaluation of the impact of repeated whole prison testing for hepatitis C. 2025.94	Evaluation	STI (inc. HCV),
+England, F	High-intensity test and treat for HCV and other STIs in a whole prison population.	M-L-M	
+Ramaswamy, et al The development of a brief jail-based cervical health promotion intervention. 2015.78	Evaluation	Cervical screening,
+USA, F	SHE cervical cancer education programme development.	M-H-H	
+Sufrin, et al Long-Acting Reversible Contraceptives for Incarcerated Women: Feasibility and Safety of On-Site Provision. 2015.88	Case study	Contraception,
+USA, F	Contraceptive programme including counselling and LARC fitting.	M-M-H	
+Sufrin, et al Family planning services for incarcerated women: models for filling an unmet need. 2017.89	Case study	Contraception,
+USA, F	Contraceptive programmes, including family planning, in 4 women’s prisons.	L-M-L	
+Thornton, et al The New Mexico Peer Education Project: Thornton et al (2018).73	Evaluation	STI (HCV),
+USA, M/F	NMPEP peer education programme for HCV risk reduction (adapted from Wall Talk).	M-M-M	
+Wallis, et al Hepatitis C virus point-of-care RNA testing: experience from screening an entire high-security Australian prison population over 3 days. 2023.92	Evaluation	STI (HCV),
+Australia, F	High-intensity HCV test and treat programme in a whole prison population.	M-L-L	
+Winter, et al A nurse‐led intervention improved blood‐borne virus testing and vaccination in Winter et al (2016).90	Evaluation	STI,
+Australia, M/F	Nurse-led programme to improve the uptake of BBV/STI testing.	M-L-M	
+BBV, blood-borne viruses; HCV, hepatitis C virus; HIV-STIC, HIV Services and Treatment Implementation in Corrections; LARC, long-acting reversable contraceptive; NIATx, Network for the Improvement of Addiction Treatment; NMPEP, Prisoner Health is Community Health: New Mexico Peer Education Project; Rel-Ric-Rig, relevance, richness, rigour; SAFE, Sexual Awareness for Everyone; SHAPE, Screening for Hepatitis C as a Prevention Enhancement; SHE, Sexual Health Empowerment; SSE, Safer Sex Education; STI, sexually transmitted infection.
+
+Regarding women’s sexual and reproductive health domains, 16 studies addressed STIs, six of which specified hepatitis C virus (HCV), four addressed cervical and/or breast screening (double-counting the Sexual Health Empowerment intervention),75 78 four contraception (double-counting a San Francisco jail intervention)88 89 and two addressed women’s health holistically. None specified menopause, menstruation or pregnancy testing, although Dang et al’s80 STI intervention was paired with pregnancy testing. The majority of studies (n=22) evaluated programmatic interventions, and two evaluated protocol interventions. The remaining studies did not evaluate implementation but provided rich insights into relevant contexts and mechanisms, so were included.97 98
+
+Main findings
+
+The analysis elicited ten cross-case ICAMOCs across the three IPT implementation process domains: planning, doing and sustaining. ICAMOCs are described narratively below, pictorially in figure 2, and summarised in table 5 with illustrative extracts from the analysis. Explanatory factors are denoted throughout by unique identifiers in the format (Xy), for example, the context ‘organisational culture’ is (C2).
+
+Table 5 Ten ICAMOCs relating to the implementation of women’s sexual and reproductive health interventions in prisons
+
+		Intervention	Context	Actor	Mechanism	Outcome	
+Planning: teaming	 ICAMOC1	I1 Sharing information to facilitate teaming	C1 Knowledge and skills
+C2 Organisational culture
+C3 Workforce capacity
+C4 Competing priorities
+C5 Values, beliefs, concerns	A1 Implementation teams
+A2 Decision-makers
+A3 Prison staff	M1 Perceived needs (of PPDW)
+M2 Perceived risks of not intervening
+M3 Perceived utility of intervention	O1 Adoption (buy-in)
+O2 Appropriateness (perceived suitability, usefulness)	
+Illustrative extract: Various administrators and staff initially expressed resistance to providing contraception during incarceration because of the potential suggestion that women were at risk for pregnancy while in custody and because they believed ‘It is not our problem’. Opinion changed when clinicians presented data demonstrating that over half the pregnant women at the facility with prior incarcerations had conceived within 3 months of release (… and)discussed different birth control methods, [and]) post-release challenges for women in accessing family planning services.89 (p. 13)	
+ ICAMOC2	I2 Effective team leadership	C3 Workforce capacity
+C4 Competing priorities
+C5 Values, beliefs, concerns
+C6 Existing relationships
+C7 Communication	A1 Implementation teams	M4 Empowerment
+M5 Shared sense of purpose
+M6 Agency (personal, collective)
+M7 Clarity, reduced uncertainty	    O1 Adoption (buy-in)
+    O3 Feasibility	
+Illustrative extract: (…)undertaking inter-organisational change with the modified NIATx approach required consistent, meaningful communication between leaders and team members. Change team leadership communication issues were linked to a host of problems, such as scheduling team meetings, delayed change cycles and even a lack of understanding among team members about the HIV-STIC process improvement strategy itself.74 (pp. 198–199)	
+Planning: assessing	 ICAMOC3	I3 Assessing needs and context through formative research	C1 Knowledge and skills
+C3 Workforce capacity
+C5 Values, beliefs, concerns
+C8 PPDW with complex needs
+C9 Availability of resources
+C10 Prison security and regime
+C11 Existing services
+C12 National recommendations	A1 Implementation teams
+A2 Decision-makers
+A4 PPDW
+A5 Deliverers	M1 Perceived needs (of PPDW /deliverers)
+M7 Clarity, reduced uncertainty	O2 Appropriateness (compatibility, relevance)
+O3 Feasibility
+O4 Acceptability (satisfaction with content)	
+Illustrative extract: (…)the principal investigator (PI) approached members of the NCDOC and prison administration to assess their capacity and interest in the project(… and)formative research was conducted to gather specific information for adapting Project SAFE for women prisoners.79 (pp. 205–206)	
+Planning: tailoring, planning	 ICAMOC4	I4 Tailoring evidence-based interventions to meet the needs of PPDW	C1 Knowledge and skills
+C5 Values, beliefs, concerns
+C8 PPDW with complex needs
+C10 Prison security and regime	A4 PPDW	M4 Empowerment
+M6 Agency (personal)
+M8 Motivation
+M9 Sense of identification (with content)	O2 Appropriateness (suitability)
+O3 Feasibility
+O4 Acceptability (satisfaction with content, credibility)	
+Illustrative extract: Like most educational programmes, we felt that a cervical health promotion intervention for incarcerated women would have to be tailored specifically to the women’s educational, social and cultural backgrounds—balancing delivery of information and empowerment for health behaviour change against the real structural constraints of their criminal justice involvement.78 (p. 433)	
+ ICAMOC5	I5 Planning integrated, universal services	C1 Knowledge and skills
+C3 Workforce capacity
+C4 Competing priorities
+C5 Values, beliefs, concerns
+C9 Availability of resources
+C10 Prison security and regime
+C11 Existing services
+C13 Short sentences	A4 PPDW
+A5 Deliverers	M7 Clarity, reduced uncertainty
+M10 Nudging
+M11 Normalisation	O3 Feasibility
+O5 Integration and reach
+O6 Cost-effectiveness	
+Illustrative extract: (…)paired screening of GC/CT with routine urine pregnancy test leads to an increased number of completed tests and a higher detection of GC and CT infections that would have otherwise been missed. Compared with testing rates before paired testing where GC/CT tests were ordered based on clinical suspicion, implementation of paired testing increased monthly testing rates by 4.7-fold.80 (pp. S21–22)	
+Doing: implementing	 ICAMOC6	I6 Piloting and testing implementation	C3 Workforce capacity
+C9 Availability of resources	A1 Implementation teams
+A2 Decision-makers
+A4 PPDW
+A5 Deliverers	M3 Perceived utility of intervention
+M7 Clarity, reduced uncertainty	O1 Adoption (intention to implement)
+O3 Feasibility
+O4 Acceptability (of content)
+O5 Integration and reach (integration)
+O7 Fidelity (delivery as intended)
+O8 Sustainability	
+Illustrative extract: As the trial went on, we learnt ways to facilitate condom skills practice in the prisons that increased participants’ level of comfort, including using humour, having the interventionists model the skills in group before having women try them, and adjusting the timing of the condom skills practice so the practices did not occur after discussing violence or while practising grounding skills, as this was triggering for some women. By the end of the trial, the condom skills practice in the prison facilities was smooth, feasible, acceptable and perceived as helpful by participants.85 (p. 3259)	
+ ICAMOC7	I7 Standardising and supporting implementation	C1 Knowledge and skills
+C3 Workforce capacity
+C8 PPDW with complex needs
+C10 Prison security and regime
+C11 Existing services
+C14 Intervention complexity	A5 Deliverers	M7 Clarity, reduced uncertainty
+M12 Increased self-efficacy	O1 Adoption (intention to implement)
+O6 Cost-effectiveness
+O7 Fidelity (delivery as intended)	
+Illustrative extract: (…)no additional human resources were required; instead, the current staff who were already trained in STI screening were trained in a new protocol and script.82 (p. 162)	
+Doing: engaging	 ICAMOC8	I8 Trauma-informed engagement	C5 Values, beliefs, concerns
+C6 Existing relationships
+C8 PPDW with complex needs
+C10 Prison security and regime	A4 PPDW	M4 Empowerment
+M6 Agency (personal)
+M8 Motivation
+M13 Feeling heard, understood, supported
+M14 Increased self-esteem
+M15 Trust	O4 Acceptability (of delivery)
+O5 Integration and reach	
+Illustrative extract: Participants were allowed to form their own groups made up of people with whom they felt comfortable. Ground rules were established at the beginning of each session. The ground rules included being respectful, listening, allowing the space to be free from judgement, maintaining confidentiality and having the freedom to leave the room if needed.84 (p. 390)	
+ ICAMOC9	I9 Engaging via peer advocates	C3 Workforce capacity
+C5 Values, beliefs, concerns
+C6 Existing relationships
+C8 PPDW with complex needs
+C10 Prison security and regime	A4 PPDW	M9 Sense of identification (with peers)
+M13 Feeling heard, understood, supported
+M15 Trust	O4 Acceptability (of delivery)
+O5 Integration and reach	
+Illustrative extract: Peer support provided by The Hepatitis C Trust which was vital for ensuring treatment adherence and following patients on treatment either to new prisons after transfer, or into the community after release. The peers have a lived experience of HCV and incarceration, meaning they are more trusted by, and can better communicate with, residents.95 (p. 7)	
+Sustaining: evaluating, adapting	 ICAMOC10	I10 Evaluation-adaptation cycles	C3 Workforce capacity
+C9 Availability of resources
+C13 Short sentences	A1 Implementation teams	M1 Perceived needs (of PPDW /deliverers)
+M3 Perceived utility of intervention
+M7 Clarity, reduced uncertainty	O2 Appropriateness
+O7 Fidelity
+O8 Sustainability	
+Illustrative extract: Ongoing monitoring can assist in the identification of time points or phases where fidelity lapses occur and result in efforts to recalibrate team performance. In HIV-STIC, fidelity monitoring served to bring problems to the attention of researchers, coaches and teams, enabling corrective action.74 (p. 199)	
+GC/CT, Neisseria gonorrhoeae and Chlamydia trachomatis; HCV, hepatitis C virus; HIV-STIC, HIV Services and Treatment Implementation in Corrections; ICAMOC, Intervention-Context-Actor-Mechanism-Outcomes configuration; NCDOC, North Carolina Department of Corrections; NIATx, Network for the Improvement of Addiction Treatment; PPDW, people in prisons that detain women; STI, sexually transmitted infection.
+
+Figure 2 ICAMO configurations 1–10. ICAMO, Intervention-Context-Actor-Mechanism-Outcome; ICAMOC, Intervention-Context-Actor-Mechanism-Outcome configuration; PPDW, people in prisons that detain women.
+
+Planning
+
+Teaming
+
+Prisons were challenging settings to implement interventions. Prison regimes (ie, routines and activities), regulations and lockdowns were restrictive, disruptive and unpredictable (C10).74 77 85 89 93 98 Recruitment challenges and competing priorities constrained workforce capacity, and facilities, equipment and funding were limited and well-guarded (C3,4,9).74 77 82 93 Accessing resources required teaming (I1,2), that is, the collaborative effort of multiple stakeholders (hereafter ‘implementation teams’) (A1) with the required ‘expertise and authority’74 (p. 189), but whose priorities may diverge, like the implicit tension of care versus control between healthcare and prison staff.7577 82 83 89 9395
+
+ICAMOC1—sharing information to facilitate teaming
+
+Analysis suggests that teaming enables implementation. This requires actors to buy-in (O1), which is influenced by prior knowledge, organisational culture, personal values, capacity and competing priorities (C1,2,5,3,4). If information is shared (I1) to engage implementation teams and decision-makers (A1,2), then buy-in is more likely, because it increases their perception of PPDW’s health needs, the risks of inaction and the relative advantage of intervention over the status quo (M1,2,3).74 77 86 89 93 Information sharing throughout implementation maintains and expands buy-in, facilitating adoption and appropriateness (O1,2), and should include prison staff (A3) as potential facilitators of access.78 84 86 92 93 95 98
+
+ICAMOC2—effective team leadership
+
+If implementation leaders provide a clear vision and practical direction (I2) for team members (A1), then the latter are more likely to prioritise implementation alongside other commitments (C4), increasing feasibility and adoption (O3,1), because they are empowered by a shared sense of purpose, agency and clarity of role (M4,5,6,7).74 77 86 94 Effective leadership is moderated by the regularity of team meetings, quality and frequency of communication and the leader’s level of commitment (C7,3,5).74 76 77 93 Leadership can be formal or informal and is facilitated by existing relationships and influence (C6).74 75 78 81
+
+Assessing needs and capacity
+
+While teaming overcame some barriers, a prison’s capacity for implementation remained a significant influencing factor. Analysis indicates that implementation strategies to add, modify or leverage resources benefitted from prior assessment of needs and potential capacity (I3).74 77 Resulting outputs were more appropriate, acceptable and feasible (O2,4,3) for PPDW, people delivering the intervention (hereafter ‘deliverers’) and decision-makers (A4,5,2) alike. Studies used various formative research methods, including focus groups, surveys, site visits, stakeholder consultations and data analysis.74 75 78 79 85 95
+
+ICAMO3—assessing needs and context through formative research
+
+If formative research is carried out (I3) to assess the needs (C1,3,5,8) of PPDW and deliverers (A4,5) and the context for implementation (C3,9,10,11), then implementation teams (A1) can tailor interventions and plan implementation to be appropriate, acceptable and feasible (O2,4,3), because they perceive the needs and preferences of those involved and uncertainty about capacity is reduced (M1,7). In studies, the needs of PPDW (A4) included learning and communication, neurodiversity, literacy, language and inclusivity alongside relevant values, beliefs and behaviours (C1,5,8).75 79 84 93 Interventions such as SHE75 78 assessed the needs of PPDW holistically within wider determinants (C8) to good effect.76 79 Capacity factors included facilities, equipment, digital resources and information systems and the limitations of security protocols and prison regimes (C9,10).77 79 83 93 98 Workforce capacity influenced implementation, encompassing skills/specialisms, training needs, time, engagement and concerns such as fearing needlestick injury (C1,3,5).73 74 77 78 83 84 93 98 Heterogeneity between prisons and non-adherence to national recommendations was observed (C11,12).82 83 90 93 98
+
+Tailoring and planning
+
+Building on formative research to tailor interventions and plan implementation increased appropriateness, acceptability and feasibility (O2,4,3). Studies found that, due to PPDW’s (A4) experiences of trauma, stigma and lack of autonomy (C8,5,10), designing empowering interventions that enabled informed decision-making motivated health-promoting behaviours (M4,6,8).78 79 85 87 88 93 Furthermore, selecting safe, streamlined, timely innovations/programmes increased access to results/care, as many PPDW serve short sentences (C13).75 92 94 95 98
+
+ICOMOC4—tailoring evidence-based interventions to meet the needs of people in prisons that detain women
+
+If evidence-based frameworks and interventions are adopted/adapted (I4)737985 86 to design interventions which meet the needs (C1,5,8,10) of PPDW (A4), then implementation will be more acceptable and appropriate (O4,2), because PPDW identify with the content and feel empowered and able to make health-promoting decisions (M9,4,6,8). Engaging PPDW in tailoring activities was found to assist this process.78 85 87
+
+ICOMOC5—planning integrated, universal services
+
+Rapid, intensive interventions can be resource-heavy and lack sustained impact.92 94 Conversely, if strategies integrate interventions (I5) into existing processes (C11), then feasibility, cost-effectiveness and engagement (O3,6,5) improve, particularly when nudged (M10) by universal, opt-out offers.808486 94 95 98 Furthermore, universal offers normalise (M11) screening for PPDW (A4) by reducing stigma and increasing exposure on recidivism (C5,13) and for deliverers (A5) by reducing the burden of risk assessment (contingent on time, knowledge, priorities and preconceptions (C3,1,4,5)), decreasing uncertainty (M7) and increasing asymptomatic disease detection.808294 98 Analysis suggests integration with reception screening increases access, befitting short sentences and prison regimes (C11,13,10), but potentially overwhelms PPDW (A4) with competing priorities and procedures (C4).7883 84 86 87 9395 98 Strategies using in-reach, telemedicine or single-point-of-access models may reduce structural barriers but require careful planning.91 96 98 While some implementations leverage existing skills and assets (C1,3,9),73 93 95 sufficient time for workforce recruitment, training, information system development and funding applications is required.78 79 84 85 87 91 94
+
+Doing
+
+Implementing
+
+Even when implementation had adequate planning and stakeholder support, prisons remained unpredictable, complex systems for action.74 79
+
+ICAMOC6—piloting and testing implementation
+
+Given resource constraints and workforce capacity (C9,3), analysis suggests that if interventions are initially piloted (I6), then implementation teams, deliverers, decision-makers and PPDW (A1,5,2,4) can perceive its utility and gain clarity about its effectiveness (M3,7), informing iterative refinement to ensure feasibility and acceptability, thus enabling fidelity and wider adoption (O3,4,7,1).747679 84 85 In the studies, pilots ranged from several days75 to several months,74 depending on intervention type. After piloting, incremental adoption improved integration and sustainability (O5,8), reducing the confusion (M7) caused by multiple short-lived interventions.88 92 93
+
+ICAMOC7—standardising and supporting implementation
+
+If introductory training and standardised operating procedures (SOPs) (I7) are provided to deliverers (A5), then adoption, fidelity and cost-effectiveness improve (O1,7,6), within workforce capacity and skill constraints, and particularly when interventions are complex (C3,1,14), because they gain clarity about the process, reducing uncertainty and improving self-efficacy (M7,12).74 75 77 82 86 This is moderated by ongoing technical, clinical, administrative and emotional support, such as helping peers cope with difficult conversations or providing guidance on data utilisation.74 85 93 95 Analysis suggests that SOPs consider the whole intervention pathway to aid responsiveness, including linkages to care, escalation/referral routes and contingency plans (C11,8,10).74 75 79 83
+
+Engaging
+
+While the implementation processes discussed thus far highlight the overall importance of engagement, this section focuses specifically on what works to engage PPDW in interventions.
+
+Studies concurred that for PPDW (A4), lifetime trauma was common and imprisonment was distressing and disempowering (C8,10).75 84 93 Previous negative experiences fostered deep-seated mistrust of healthcare deliverers, and fear of stigma, judgement, tests and disease were common (C5,6).7578 86 93 9698 PPDW often felt misunderstood and disinclined to seek help or disclose personal information (M13,8).93 97 Fasula et al79 highlight the correlation between a PPDW’s self-esteem and their motivation to adopt health-promoting behaviours (M14,8).
+
+ICAMOC8—trauma-informed engagement
+
+If deliverers (A5) adopt empathetic, trauma-informed approaches throughout the intervention pathway (I8), then PPDW (A4) engage more (O5), because they feel heard, understood and supported, which builds self-esteem, agency and trust, increasing empowerment and motivation (M13,14,6,15,4,8) and improving acceptability (O4).75 78 79 84 85 93 96 97 Trauma-informed methods facilitate informed decision-making through affirmations, tailored education, information-sharing, signposting, expectation-setting and offering choices.78 85 87 88 93 Group modalities promote emotional safety, decreasing power differentials and fostering social support.75 84 85 Flyers, posters, workshops and word-of-mouth can raise awareness, and verbal communication helps overcome literacy barriers.73 75 78 88 Optimising coverage should be weighed against giving sufficient time for decision-making to avoid coercion, particularly for long-acting contraception.88 89
+
+ICAMOC9—engaging via peer advocates
+
+If advocacy, particularly by peers (I9), is provided, then acceptability, integration and reach increase (O4,5), because PPDW (A4) identify with and trust them (M9,15) and because increased opportunities to engage within the prison regime (eg, housing blocks, reception and post-release) (C10) help them feel heard and supported (M13).73 93 95 98 Analysis suggests that, with appropriate training and support, peers find advocacy roles affirming and empowering, becoming champions for the intervention and augmenting workforce capacity (C3).73 93
+
+Sustaining
+
+Evaluating and adapting
+
+Although the CFIR distinguishes between reflection and evaluation, characterised by the collection and analysis of information and adaptation of the intervention or context, they are combined here as study data support adopting an ongoing, iterative process for improved sustainability and relevance.
+
+ICAMOC10—evaluation-adaptation cycles
+
+If evaluation-adaptation cycles are employed (I10), based on relevant information and feedback,74 79 then appropriateness, fidelity and sustainability improve (O2,7,8), because implementation teams (A1) gain clarity over the utility of the intervention and whether implementation meets the needs of deliverers and recipients (M7,3,1) within the context of available resources (C3,9).74 79 83 85 Studies sought feedback from various stakeholders, including peers, deliverers and PPDW, although short sentences and abrupt cessation (C13,9) of funding sometimes hindered collection.76 78 79 81 87 93 Focus groups, surveys, information systems and evaluation tools were used, but data availability and its effective utilisation were limited and the importance of impartiality and transparency were stressed.74 77 79 83 85 87 90 93 95 Pankow et al74 recommend ongoing process evaluation to ensure fidelity (O7), while elsewhere positive feedback was noted as rewarding for deliverers.93
+
+Refined programme theory
+
+Explanatory factors from cross-case ICAMOCs were used to refine the PT (see figure 3). The mechanisms identified were grouped into three higher level mechanisms found to be relevant to all actors, namely, perceived utility of intervention, motivation to implement and empowerment to take action.
+
+Figure 3 Refined programme theory. PPDW, people in prisons that detain women.
+
+Discussion
+
+Summary of findings
+
+We identified three overarching themes. First, workforce capacity is a significant constraining factor when implementing women’s sexual and reproductive health interventions in prisons. Recruitment and retention are ongoing issues for prison staff and deliverers, for whom core duties are reactive and challenging. Deliverers can feel uncertain and lack time and resources to manage competing priorities effectively. Analysis indicates effective leadership, training, ongoing support and SOPs enable deliverers to perceive the utility of implementing interventions and gain clarity about their role. Universal and opt-out offers reduce reliance on deliverers’ time and inclination to risk assess and on a PPDW’s willingness to disclose medical or behavioural history, thereby increasing coverage. Mobilising peers from the prison population and/or external organisations can enhance capacity, providing an affirming experience for the peer when adequately trained and supported.73 93 Actor types involved in planning should seek to empower the workforce through training, support and augmentation to make implementation more feasible and acceptable.
+
+Second, the persistence of competing priorities hinders engagement across all actor types. Decision-makers and prison staff work within strict protocols to safeguard the workforce and PPDW, prioritising security. Healthcare deliverers necessarily prioritise high-volume urgent medical needs within resource constraints. PPDW do not often prioritise their sexual and reproductive health, particularly at reception when coping with, for example, mother-child separation, substance withdrawal and situational distress—as Hilkey postulates, Maslow’s theory of human motivation places such pressing physiological and psychological needs above health-promotion in prisons.99 This is evident in the dominance of HCV and HIV studies in this review which, while included here as STIs, may be prioritised over other women’s sexual and reproductive health issues (like menstruation or menopause) due to their association with intravenous drug use. Education and information-sharing to increase understanding of women’s sexual and reproductive health needs and associated risks enable actors to perceive the utility of intervention, increasing their motivation for intervention. This aligns with the concepts of perceived susceptibility, severity and benefits central to the Health Belief Model.100 Sustained, meaningful efforts to raise awareness about women’s sexual and reproductive health in prisons are needed. Several studies demonstrated that long-term research partnerships can facilitate this and help to expand the evidence base.73 74 78
+
+Lastly, adopting a trauma-informed approach throughout implementation activities is an important enabling factor. PPDW often have significant lifetime trauma resulting in low self-esteem, low self-efficacy and pervading fear and mistrust. People who use drugs and sex workers can feel stigmatised and misunderstood, and prisons fundamentally and profoundly restrict autonomy. The resulting sense of disempowerment is worsened when deliverers seem judgemental, disinterested or dismissive. In contrast, empathetic interactions in which PPDW feel emotionally safe to talk openly and feel heard and understood are empowering and normalising. Providing education and opportunities for PPDW to make informed, uncoerced decisions about their health aligns with the self-determination theory of motivation.101 Furthermore, group activities which promote respect, equality and acceptance offer much-needed opportunities for PPDW to build social support. Advocate roles, including peer-based programmes, can provide trustworthy support, bridging the gap between deliverer and recipient, and should be considered in all prison settings. There is increasing evidence to support trauma-informed care in prisons, and on-going investment in workforce training and the adoption of trauma-informed care throughout the prison estate, or network, is recommended.102104
+
+Conclusions and recommendations
+
+The Chief Medical Officer’s 2025 annual report on the physical health of people in England’s prisons recommends prioritising health prevention interventions to tackle inequities within the system and improve health outcomes.5 Recognising the complex challenges of implementation in custodial settings and the unmet needs particular to PPDW, the objectives of this review were to explore what works for whom, how and why, when implementing women’s sexual and reproductive health interventions in prisons. This involved exploring the barriers and facilitators to implementation described in primary studies to generate recommendations for policymakers. The CFIR informed the IPT, which was tested and refined through realist synthesis to refine an explanatory PT (figure 3). Three main mechanisms of perceived utility of intervention, motivation and empowerment were identified and informed the following recommendations for policymakers:
+
+Build a resilient, empowered delivery workforce through training, support and augmentation.
+
+Invest in research partnerships to increase awareness and understanding of women’s sexual and reproductive health in prisons and address the evidence gap.
+
+Promote trauma-informed methods to develop and deliver women’s sexual and reproductive health services throughout the prison estate.
+
+Strengths and limitations
+
+A strength of this review is that it synthesises evidence from a range of sources to theorise what works when implementing women’s health interventions in prisons. This addresses a significant gap in the literature and could form the basis for further research through case studies or as new studies emerge. While including unpublished literature may lower publication bias, only studies from high-income countries published in English since 2010 were included, which was a limitation of the search strategy. Furthermore, the predominance of North American studies (n=19) may limit generalisability to England, particularly given policy differences in criminal justice and healthcare systems.
+
+None of the studies focused specifically on menopause, menstruation or pregnancy testing, despite searches including these terms. In addition, use of the WHH specification and prison policy/guidance to define women’s sexual and reproductive health domains may have excluded relevant alternatives, such as abortion. The search strategy could have been further strengthened by including specific search terms for non-binary and gender diverse participants. While Pawson et al57 advise pragmatism to balance theoretical saturation with the availability of studies and time, further purposive sampling could have been undertaken. These limitations could have been addressed, and the search strategy strengthened, through stakeholder or advisory group involvement.
+
+Supplementary material
+
+10.1136/bmjopen-2025-113940 online supplemental file 1
+
+Data availability statement
+
+Data are available upon reasonable request.
+
+Review Process File
+
+Electronic publication date: 2026 Jun 22
+
+Funding: This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Prof GJM-T is a National Institute for Health and Care Research (NIHR) Senior Investigator. The opinions expressed in the article do not necessarily reflect the opinions of NIHR, the Department of Health and Social Care or the UK Government.
+
+Prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2025-113940).
+
+Provenance and peer review: Not commissioned; externally peer reviewed.
+
+Patient consent for publication: Not applicable.
+
+Ethics approval: General ethics approval via the low-risk ethics route was gained from the University of Exeter College of Medicine and Health Research Ethics Committee (reference Sept21/B/263∆1).
+
+Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
+
+
+References
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+62 De Weger E Van Vooren NJE Wong G et al What’s in a Realist Configuration? Deciding Which Causal Configurations to Use, How, and Why Int J Qual Methods 2020 19 10.1177/1609406920938577
+63 Abejirinde I-O Ilozumba O Marchal B et al Mobile health and the performance of maternal health care workers in low- and middle-income countries: A realist review Int J Care Coord 2018 21 73 86 10.1177/2053434518779491 30271609 PMC6151957
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+73 Thornton K Sedillo ML Kalishman S et al The New Mexico Peer Education Project: Filling a Critical Gap in HCV Prison Education J Health Care Poor Underserved 2018 29 1544 57 10.1353/hpu.2018.0111 30449762
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+75 Kennedy P Ratnaparkhi R Lee J et al Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants J Clin Trans Sci 2023 7 10.1017/cts.2023.561 PMC10425866 37588675
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+77 Emerson A Allison M Kelly PJ et al Barriers and facilitators of implementing a collaborative HPV vaccine program in an incarcerated population: A case study Vaccine 2020 38 2566 71 10.1016/j.vaccine.2020.01.086 32046888 PMC7133786
+78 Ramaswamy M Simmons R Kelly PJ The development of a brief jail-based cervical health promotion intervention Health Promot Pract 2015 16 432 42 10.1177/1524839914541658 25063589 PMC4306642
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+80 Dang CM Pao J Taherzadeh D et al Paired Testing of Sexually Transmitted Infections With Urine Pregnancy Tests in Incarcerated Women Sex Transm Dis 2021 48 S20 5 10.1097/OLQ.0000000000001456 34110729 PMC8284383
+81 Cocoros N Nettle E Church D et al Screening for Hepatitis C as a Prevention Enhancement (SHAPE) for HIV: an integration pilot initiative in a Massachusetts County correctional facility Public Health Rep 2014 129 Suppl 1 5 11 10.1177/00333549141291S102 PMC3862988 24385643
+82 Cole J Hotton A Zawitz C et al Opt-out screening for Chlamydia trachomatis and Neisseria gonorrhoeae in female detainees at Cook County jail in Chicago, IL Sex Transm Dis 2014 41 161 5 10.1097/OLQ.0000000000000106 24521720
+83 Harmon JL Dhaliwal SK Burghardt NO et al Routine Screening in a California Jail Public Health Rep 2020 135 57S 64S 10.1177/0033354920928454 32735188 PMC7407048
+84 Holton LM Hampton MD Implementing High-Intensity, Trauma-Informed Sexual Risk Reduction in Women Involved in the Criminal Legal System J Correct Health Care 2023 29 387 94 10.1089/jchc.22.09.0072 37815788
+85 Johnson JE Peabody ME Wechsberg WM et al Feasibility of an HIV/STI Risk-Reduction Program for Incarcerated Women Who Have Experienced Interpersonal Violence J Interpers Violence 2015 30 3244 66 10.1177/0886260514555013 25395223 PMC4429003
+86 Murphy M Rogers BG Ames E et al Implementing Preexposure Prophylaxis for HIV Prevention in a Statewide Correctional System in the United States Public Health Rep 2024 139 174 9 10.1177/00333549231186576 37476929 PMC10851896
+87 McNeely CA Hutson S Sturdivant TL et al Expanding Contraceptive Access for Women With Substance Use Disorders: Partnerships Between Public Health Departments and County Jails J Public Health Manag Pract 2019 25 229 37 10.1097/PHH.0000000000000850 30234670
+88 Sufrin C Oxnard T Goldenson J et al Long‐Acting Reversible Contraceptives for Incarcerated Women: Feasibility and Safety of On‐Site Provision Perspect Sexual Reproductive 2015 47 203 11 10.1363/47e5915 26484795
+89 Sufrin C Baird S Clarke J et al Family planning services for incarcerated women: models for filling an unmet need IJPH 2017 13 10 8 10.1108/IJPH-07-2016-0025 28299966
+90 Winter RJ White B Kinner SA et al A nurse‐led intervention improved blood‐borne virus testing and vaccination in Victorian prisons Aust N Z J Public Health 2016 40 592 4 10.1111/1753-6405.12578 27774690
+91 Hesse S Williamson K Bonney D et al Cancer screening in prisons: lessons for health providers Aust J Prim Health 2023 29 16 9 10.1071/PY22120 36442073
+92 Wallis C O’Flynn M Fenech M et al Hepatitis C virus point-of-care RNA testing: Experience from screening an entire high-security Australian prison population over 3 days Aust N Z J Public Health 2023 47 100083 10.1016/j.anzjph.2023.100083 37776597
+93 Against Violence & Abuse An evaluation of women in prison’s health matters project. London 2019 Available https://womeninprison.org.uk/media/downloads/health-matters-final-evaluation-report.pdf
+94 Phaw NA Thant AM Thompson C et al Prospective evaluation of the impact of repeated whole prison testing for hepatitis C BMJ Open Gastroenterol 2025 12 e001593 10.1136/bmjgast-2024-001593 PMC11815426 39933779
+95 Mongale E Allen S Brew I et al Development and optimisation of a reception testing protocol designed to eliminate HCV in the UK prison population JHEP Rep 2024 6 100937 10.1016/j.jhepr.2023.100937 38169900 PMC10758963
+96 Besney JD Angel C Pyne D et al Addressing Women’s Unmet Health Care Needs in a Canadian Remand Center: Catalyst for Improved Health? J Correct Health Care 2018 24 276 94 10.1177/1078345818780731 29925287
+97 Paynter M Heggie C McLeod A et al The experiences of family planning health professionals providing care to incarcerated patients: a qualitative study BMC Pregnancy Childbirth 2025 25 856 10.1186/s12884-025-07913-5 40813962 PMC12355797
+98 Crowley D Van Hout MC Murphy C et al Hepatitis C virus screening and treatment in Irish prisons from nurse managers’ perspectives - a qualitative exploration BMC Nurs 2019 18 23 10.1186/s12912-019-0347-x 31210751 PMC6567378
+99 Hilkey JH A Theoretical Model for Assessment of Delivery of Mental Health Services in the Correctional Facility Psychiatr Ann 1988 676 9
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+104 Harner H Burgess AW Using a Trauma‐Informed Framework to Care for Incarcerated Women J Obstet Gynecol Neonatal Nurs 2011 40 469 76 10.1111/j.1552-6909.2011.01259.x 21894637
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+106 Westhorp G Understanding mechanisms in realist evaluation and research Emmel N Greenhalgh J Manzano A et al Doing realist research London SAGE Publications Ltd 2018 41 58 Available 10.4135/9781526451729.n4
+107 Cambon L Terral P Alla F From intervention to interventional system: towards greater theorization in population health intervention research BMC Public Health 2019 19 10.1186/s12889-019-6663-y PMC6434858 30909891
+108 Pearsons A Neubeck L Hendriks JM et al Justification, rationale and methodological approaches to realist reviews Eur J Cardiovasc Nurs 2023 22 107 12 10.1093/eurjcn/zvac068 35881526
diff --git a/corpus/healthcare/text/d8be12a2fdd2b133.txt b/corpus/healthcare/text/d8be12a2fdd2b133.txt
new file mode 100644
index 0000000000000000000000000000000000000000..82cfdfead60a652b7dcdab91b2d45515cb9583bb
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+++ b/corpus/healthcare/text/d8be12a2fdd2b133.txt
@@ -0,0 +1,70 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Immunol
+Journal ID: Front Immunol
+NLM Journal ID: 101560960
+Journal ID: Front. Immunol.
+
+Frontiers in Immunology
+
+EISSN: 1664-3224
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12305368
+PMID: 40735317
+DOI: 10.3389/fimmu.2025.1651209
+Article version: 1
+Subjects: Immunology, Correction
+
+Correction: Evaluating the predictive effect of vitamin D on clinical outcomes of infliximab-treated Crohn’s disease patients
+
+Zheng Jiao 1
+Gao Hongping 1
+Zhang Yu 1
+Sun Mingxuan 1
+Sun Hang 1
+Pei Ying 2 *
+1 Department of Anorectal, Affiliated Municipal Hospital of Xuzhou Medical University , Xuzhou, Jiangsu , China
+2 Department of Endocrinology, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University , Xuzhou, Jiangsu , China
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
+*Correspondence: Ying Pei, peiying2901@163.com
+Electronic publication date: 2025 Jul 15
+Publication date: 2025
+Volume: 16
+Electronic Location ID: 1651209
+Received 2025 Jun 21; Accepted 2025 Jun 30
+Copyright: Copyright © 2025 Zheng, Gao, Zhang, Sun, Sun and Pei
+Copyright year: 2025
+Copyright holder: Zheng, Gao, Zhang, Sun, Sun and Pei
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Evaluating the predictive effect of vitamin D on clinical outcomes of infliximab-treated Crohn’s disease patients 16 4 6 2025 1578191 Frontiers in Immunology 10.3389/fimmu.2025.1578191 PMC12175088 40534845
+Keywords: Crohn’s disease, vitamin D, infliximab, remission rate, gastroenterology
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 1
+
+section-in-acceptance: Nutritional Immunology
+
+Ÿ==============================Ÿ
+Affiliation “Department of Endocrinology, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, Jiangsu, China.” was erroneously omitted for author “Ying Pei”, and was incorrectly listed as “Department of Anorectal, Affiliated Municipal Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China”. This has been corrected to read:
+
+“Jiao Zheng 1, Hongping Gao1, Yu Zhang1, Mingxuan Sun1, Hang Sun1, Ying Pei2.
+
+1. Department of Anorectal, Affiliated Municipal Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
+
+2. Department of Endocrinology, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University, Xuzhou, Jiangsu, China
+
+The original version of this article has been updated.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
diff --git a/corpus/healthcare/text/d8bfdc366965dfec.txt b/corpus/healthcare/text/d8bfdc366965dfec.txt
new file mode 100644
index 0000000000000000000000000000000000000000..d8ce2c1fbd4495003d5dee060e5f94d9ebf0ae0d
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+++ b/corpus/healthcare/text/d8bfdc366965dfec.txt
@@ -0,0 +1,84 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Oral Health
+Journal ID: Front Oral Health
+NLM Journal ID: 9918227262706676
+Journal ID: Front. Oral Health
+
+Frontiers in Oral Health
+
+EISSN: 2673-4842
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13386051
+PMID: 42482742
+DOI: 10.3389/froh.2026.1917692
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Prevalence, predictors and severity of xerostomia in adult patients in general dental care
+
+Adolfsson Anna 1 2 * Conceptualization Formal analysis Funding acquisition Methodology Supervision Writing – original draft Writing – review & editing
+Lenér Frida 3 4 † Formal analysis Writing – original draft Writing – review & editing
+Almståhl Annica 5 6 Conceptualization Methodology Supervision Writing – review & editing
+Almhöjd Ulrica 7
+Marklund Bertil 3 † Conceptualization Methodology Supervision Writing – review & editing
+Çevik-Aras Hülya 1 8
+1 Department of Oral Medicine and Pathology, Institute of Odontology, University of Gothenburg , Gothenburg , Sweden
+2 Specialist Clinic of Orofacial Medicine Uddevalla/Trollhättan , Trollhättan , Sweden
+3 Region Västra Götaland, Research, Education, Development & Innovation (REDI), Primary Health Care , Gothenburg , Sweden
+4 Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
+5 Department of Microbiology and Immunology, Institute of Odontology, University of Gothenburg , Gothenburg , Sweden
+6 Department of Oral Health, Faculty of Odontology, Malmö University , Malmö , Sweden
+7 Chalmers University of Technology , Gothenburg , Sweden
+8 Section of Oral Biology and Immunopathology/Oral Medicine, Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen , Denmark
+* Correspondence: Anna Adolfsson anna.adolfsson@odontologi.gu.se† ORCID Frida Lenér orcid.org/0000-0003-2096-4352 Bertil Marklund orcid.org/0000-0001-5110-0739
+
+Electronic publication date: 2026 Jul 7
+Publication date: 2026
+Volume: 7
+Electronic Location ID: 1917692
+Received 2026 Jun 23; Revised 2026 Jun 23; Accepted 2026 Jun 24
+Copyright: © 2026 Adolfsson, Lenér, Almståhl, Almhöjd, Marklund and Çevik-Aras.
+Copyright year: 2026
+Copyright holder: Adolfsson, Lenér, Almståhl, Almhöjd, Marklund and Çevik-Aras
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Prevalence, predictors and severity of xerostomia in adult patients in general dental care 7 1 6 2026 1795172 Frontiers in Oral Health 10.3389/froh.2026.1795172 PMC13265566 42306329
+Keywords: adult population, dry mouth, medication, oral health, polypharmacy, salivary hypofunction, xerostomia
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 2
+
+section-at-acceptance: Oral Epidemiology
+
+Ÿ==============================Ÿ
+The Data Availability statement was erroneously given as ‘The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.’
+
+The correct Data Availability statement is ‘The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to ethical restrictions.’
+
+The ethics statement was erroneously given as ‘All members are part of the Swedish Ethical Review Authority-committee Magnus ForsbergÅsa HannaRonnie LundströmPeter AppelrosHugo LövheimJenny PerssonUlrika Pettersson KymmerSven Arne SilfverdalThomas BrännströmMikael Sandlund Per-Erik Lundmark Christina Snell Lumio Lars-Erik Olofsson Mats DahlströmAnn-Britt GrünewaldInger Trodell DahlAgne FuringstenKristina ArnrupLars-Gunnar GunnarssonYvonne Freund-LeviMartin HöglundMargareta MöllerOlof ErikssonArja Harila-SaariMårten FryknäsJaneth Leksell. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.’
+
+The correct ethics statement is ‘The studies were approved by the Swedish Ethical Review Authority (Dnr 2020-03094 and Dnr 2021-04213) and were henceforth conducted in accordance with stated requirements. Participants provided written informed consent prior to participation.’
+
+The Generative AI statement: States that we have used generative AI in the creation of this manuscript. We have not used any generative AI.
+
+A correction has been made to the section Generative AI statement:
+
+“The author(s) declared that no generative AI was used in the creation of this manuscript”
+
+The original version of this article has been updated.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
diff --git a/corpus/healthcare/text/da0f7261a1e2c32b.txt b/corpus/healthcare/text/da0f7261a1e2c32b.txt
new file mode 100644
index 0000000000000000000000000000000000000000..154de216963a419f52ffaad04bd69e9d05901545
--- /dev/null
+++ b/corpus/healthcare/text/da0f7261a1e2c32b.txt
@@ -0,0 +1,763 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Oral Health
+Journal ID: BMC Oral Health
+NLM Journal ID: 101088684
+
+BMC Oral Health
+
+EISSN: 1472-6831
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12065305
+PMID: 40349034
+DOI: 10.1186/s12903-025-06015-0
+Article ID: 6015
+Article version: 1
+Subjects: Systematic Review
+
+Association between antiretroviral therapy and dental caries in children and adolescents with HIV: a systematic review and meta-analysis
+
+Aguirre-Ipenza Rubén raguirrei@continental.edu.pe
+1
+Bautista-Pariona Anthony 2 3
+Viguria-Chavez Yolanda 4 5
+Huapaya-Cabrera Alejandro Hector 6
+Coronel-Zubiate Franz Tito 3 7
+Luján-Valencia Sara Antonieta 8 9
+Amaya-Riveros Elda 10
+Arbildo-Vega Heber Isac 11 12
+1 https://ror.org/05rcf8d17 grid.441766.6 0000 0004 4676 8189 Faculty of Health Sciences, Universidad Continental, Lima, 15046 Perú
+2 https://ror.org/03zmnt269 grid.441924.e 0000 0004 0418 8557 Faculty of Human Medicine, Universidad Nacional del Santa, Ancash, Perú
+3 Instituto Privado de Estadística e Investigación en Salud, Lima, Perú
+4 https://ror.org/03yczjf25 grid.11100.31 0000 0001 0673 9488 School of Public Health, Universidad Peruana Cayetano Heredia, Lima, Perú
+5 https://ror.org/03yczjf25 grid.11100.31 0000 0001 0673 9488 Parasitology Unit, Alexander von Humboldt Institute of Tropical Medicine, Universidad Peruana Cayetano Heredia, Lima, Perú
+6 https://ror.org/05t6q2334 grid.441984.4 0000 0000 9092 8486 Faculty of Health Sciences, Universidad Privada del Norte, Lima, Perú
+7 https://ror.org/0323wfn23 grid.441710.7 0000 0004 0453 3648 Faculty of Health Sciences, Stomatology School, Universidad Nacional Toribio Rodríguez de Mendoza de Amazonas, Chachapoyas, Perú
+8 https://ror.org/027ryxs60 grid.441990.1 0000 0001 2226 7599 Faculty of Dentistry, Dentistry School, Universidad Católica de Santa María, Arequipa, Perú
+9 https://ror.org/00987cb86 grid.410543.7 0000 0001 2188 478X Department of Diagnostics and Surgery, School of dentistry, Paulista State University Julio de Mesquita Filho (UNESP), Araraquara, Sao Paulo, Brazil
+10 https://ror.org/03deqdj72 grid.441816.e 0000 0001 2182 6061 Institute of Government and Public Management, Universidad de San Martín de Porres, Lima, Perú
+11 https://ror.org/03deqdj72 grid.441816.e 0000 0001 2182 6061 Faculty of Dentistry, Dentistry School, Universidad de San Martín de Porres, Chiclayo, Perú
+12 https://ror.org/03deqdj72 grid.441816.e 0000 0001 2182 6061 Faculty of Human Medicine, Human Medicine School, Universidad de San Martín de Porres, Chiclayo, Perú
+Electronic publication date: 2025 May 10
+Publication date: 2025
+Volume: 25
+Electronic Location ID: 700
+Received 2024 Dec 31; Accepted 2025 Apr 16
+Copyright: © The Author(s) 2025
+Copyright year: 2025
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Antiretroviral therapy, Dental caries, Children, HIV, Oral health, Systematic review
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2025
+
+Ÿ==============================Ÿ
+Objective
+
+To evaluate the evidence regarding the association between antiretroviral therapy and dental caries in children and adolescents with HIV.
+
+Methods
+
+Searches were conducted in five international databases (PubMed, Scopus, EMBASE, CENTRAL, and LILACS) from the inception of records up to October 2024, including studies that examine the impact of antiretroviral therapy on caries in individuals under 18 years of age. The risk of bias was assessed using the Newcastle–Ottawa Scale. Quantitative synthesis was performed using the inverse variance method or Mantel–Haenszel method, depending on the type of outcome analyzed. Measures of association included odds ratios and mean differences, employing a random-effects model with a 95% confidence interval.
+
+Results
+
+A total of 585 studies were identified, of which 17 were selected for qualitative review and 15 were included in the meta-analysis. The meta-analysis revealed a significantly higher risk of dental caries in children and adolescents with HIV undergoing antiretroviral therapy compared to those without the virus (odds ratio of 2.11; 95% CI: 1.41–3.17). Subgroup analysis showed a stronger association in case–control studies and for the DMFT index. The certainty of the evidence according to GRADE was rated as very low.
+
+Conclusion
+
+Despite limited certainty, the results suggest that HIV under antiretroviral therapy is associated with a higher risk of dental caries. It is prudent to interpret these results with caution, considering the methodological limitations of the studies. However, given the possible relevance of this association for public health, it is recommended to consider specific dental care protocols for children and adolescents with HIV, as well as the need for preventive strategies integrated into HIV management.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12903-025-06015-0.
+
+Background
+
+The human immunodeficiency virus (HIV) remains a significant global public health concern, especially in vulnerable populations such as children and adolescents. The World Health Organization (WHO) estimates that in 2023 there were approximately 39.9 million people living with HIV, with a high impact on vulnerable groups, including children [1]. Antiretroviral therapy (ART), previously classified as standard antiretroviral therapy (s-ART, consisting of one or two drugs) and highly active antiretroviral therapy (HAART, with three or more drugs from different classes), has transformed HIV management, significantly improving both the quality of life and life expectancy of infected patients [2, 3]. However, the prolonged use of these therapies can lead to side effects ranging from metabolic problems to alterations in the oral microbiota, a crucial aspect for dental and general health [4, 5].
+
+In patients with HIV, the infection and continuous use of ART, including what was previously classified as HAART, can alter the balance of the oral microbiota due to their impact on the host's immune system and the bacterial equilibrium in the mouth. These changes can favor the growth of cariogenic bacteria, increasing the risk of developing dental caries [6].
+
+Understanding how ART, in all its modalities, influences oral health is crucial to fully comprehend the side effects of the treatment [7]. Previous studies have suggested that children and adolescents with HIV may have a higher risk of developing dental caries due to alterations in the oral microbiota, an effect that could be exacerbated by ART [8, 9].
+
+Exploring the relationship between ART and dental caries in children and adolescents with HIV is essential not only to improve clinical management strategies but also to develop effective preventive interventions [10]. Delving into this possible relationship would help dentists and physicians design specific dental care protocols for this population, which could potentially reduce the burden of dental caries and improve patients'quality of life.
+
+Nevertheless, the direct impact of ART on dental caries in pediatric populations remains insufficiently documented. Although there are reviews that explore various aspects of oral health in patients with HIV [11, 12], most have not adopted structured approaches (such as Summary of Findings tables) to synthesize the quality of the evidence nor have they adequately addressed the influence of different subgroups. Consequently, a knowledge gap persists regarding the specific association between ART and the incidence of caries in children and adolescents. This gap underscores the need for a systematic review and meta-analysis to address these limitations. By focusing on the pediatric and adolescent population, this study aims to fill that gap through a detailed assessment of how ART, including previously utilized therapeutic regimens, influences the incidence and severity of dental caries.
+
+The objective of this systematic review and meta-analysis is to evaluate the association between the administration of antiretroviral therapy and the incidence and severity of dental caries in children and adolescents with HIV. This study intends to provide solid and synthesized evidence that can guide clinical practices and health policies to improve the oral health of this vulnerable population.
+
+Methods
+
+This systematic review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [13], as detailed in Appendix 1. The protocol was registered in the International Prospective Register of Systematic Reviews – PROSPERO (CRD42024605937).
+
+The PECO components of the question were as follows:P: Children and adolescents under 18 years
+
+E: Diagnosed with HIV who have received antiretroviral therapy
+
+C: Without HIV or diagnosed with HIV who have not received antiretroviral therapy
+
+O: Dental caries
+
+To isolate the effect of ART on the incidence of caries in children and adolescents, we considered two types of comparator groups:HIV-negative individuals: This group serves to identify whether the combination of HIV infection plus ART exposure confers a higher risk of caries compared to those without infection.
+
+HIV-positive individuals without ART: By including children and adolescents with HIV who have not started antiretroviral therapy, we can specifically assess how treatment influences caries risk among individuals who share the same HIV status but differ in exposure to therapy.
+
+Eligibility criteria
+
+Inclusion and exclusion criteria were established using the PECO method, focusing on comparative studies, including cohort, case–control, and cross-sectional studies that evaluated the association between antiretroviral therapy used in HIV treatment and dental caries in individuals under 18 years of age. This age range was chosen due to its importance in critical periods of dental development and general health. Studies specifically evaluating antiretroviral therapy as a factor associated with dental caries were included, presenting data on the presence or absence of caries, measured numerically (e.g., DMFT/dmft index) or categorically, in both exposed (HIV-infected individuals receiving antiretroviral therapy) and unexposed groups. No restrictions were applied regarding language, publication date, follow-up duration, or sample size. Review studies, conference abstracts, case reports, and studies conducted on animals or ex vivo samples were excluded.
+
+Search strategy
+
+A systematic search was conducted for articles published up to October 2024 in Medline (via PubMed), Scopus, the Cochrane Library (CENTRAL), EMBASE, and LILACS, using search terms related to"dental caries,""antiretroviral therapy,"and"highly active antiretroviral therapy". Since our initial search in LILACS appeared too restrictive, we updated and expanded the search strategy in this database in February 2025 to ensure comprehensiveness. Additionally, gray literature was explored through OpenGrey and Google Scholar, reviewing the first 100 results on both platforms. References of included studies were also reviewed to identify potential additional studies not found in the databases. Finally, a manual search was performed in the leading journals specializing in HIV and general dentistry, including Future Virology, BMJ Paediatrics Open, Indian Journal of Dental Research, Journal of Oral Pathology & Medicine, and BMC Oral Health. The search strategy for each database is detailed in Table 1. Table 1 Search strategy for each search engine
+
+Database	Strategy	Results	
+PubMed	("antiretroviral therap*"[Title/Abstract] OR"antiretroviral therapy, highly active"[MeSH Terms] OR"HAART"[Title/Abstract] AND ("Dental Caries"[MeSH Terms] OR"Dental Caries Susceptibility"[MeSH Terms] OR"Root Caries"[MeSH Terms] OR ("dent*"[Title/Abstract] AND"cari*"[Title/Abstract]) OR"Decay"[Title/Abstract] OR"caries"[Title/Abstract] OR"tooth decay"[Title/Abstract] OR"carious lesion*"[Title/Abstract] OR"dental cavit*"[Title/Abstract] OR"carious dentin*"[Title/Abstract])	393	
+CENTRAL	#1	MeSH descriptor: [Antiretroviral Therapy, Highly Active] explode all trees	1630	
+#2	(antiretroviral therap*):ti,ab,kw	9655	
+#3	(HAART):ti,ab,kw	1322	
+#4	MeSH descriptor: [Dental Caries] explode all trees	3727	
+#5	MeSH descriptor: [Dental Caries Susceptibility] explode all trees	276	
+#6	MeSH descriptor: [Root Caries] explode all trees	120	
+#7	(dent* AND cari*):ti,ab,kw	9157	
+#8	("decay"):ti,ab,kw	1791	
+#9	("caries"):ti,ab,kw	9261	
+#10	(tooth decay):ti,ab,kw	603	
+#11	(carious lesion*):ti,ab,kw	1824	
+#12	(dental cavit*):ti,ab,kw	4477	
+#13	(carious dentin*):ti,ab,kw	1028	
+#14	#1 OR #2 OR #3	9964	
+#15	#4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13	14322	
+Final	#14 AND #15	80	
+Scopus	(INDEXTERMS("antiretroviral therapy, highly active") OR TITLE-ABS("antiretroviral therap*") OR TITLE-ABS(HAART)) AND (INDEXTERMS("Dental Caries") OR INDEXTERMS("Dental Caries Susceptibility") OR INDEXTERMS("Root Caries") OR (TITLE-ABS(dent*) AND TITLE-ABS(cari*)) OR TITLE-ABS(Decay) OR TITLE-ABS(caries) OR TITLE-ABS("tooth decay") OR TITLE-ABS("carious lesion*") OR TITLE-ABS("dental cavit*") OR TITLE-ABS("carious dentin*"))	396	
+Embase	('antiretroviral therapy, highly active'/exp OR'antiretroviral therap*':ti,ab OR HAART:ti,ab) AND ('Dental Caries'/exp OR'Dental Caries Susceptibility'/exp OR'Root Caries'/exp OR (dent*:ti,ab AND cari*:ti,ab) OR Decay:ti,ab OR caries:ti,ab OR'tooth decay':ti,ab OR'carious lesion*':ti,ab OR'dental cavit*':ti,ab OR'carious dentin*':ti,ab)	501	
+LILACS	(antiretroviral therapy, highly active) AND (dental caries)	4	
+LILACS (Expanded)	("Antiretroviral Therapy") OR ("Highly Active Antiretroviral Therapy") OR (HAART) OR ("antiretroviral therapy") OR ("antiretroviral treatment") AND ("Dental Caries") OR ("Dental Caries Susceptibility") OR ("Root Caries") OR (dent* AND cari*) OR ("caries") OR ("tooth decay") OR ("carious lesion") OR ("dental cavity") OR ("carious dentin") AND db:("LILACS") AND instance:"lilacsplus"	519	
+
+Study selection
+
+One author (RAI) gathered all references from the databases into the Rayyan QCRI web application (https://rayyan.qcri.org/) and removed duplicates. Before beginning the selection process, two authors (RAI and AHC) conducted a pilot test of the inclusion criteria to reduce errors in the selection process, using the first 100 studies. Subsequently, these authors independently reviewed the titles and abstracts of the retrieved publications to identify studies that potentially met the inclusion criteria. Conflicts regarding the inclusion of any publication were resolved through discussion with a third reviewer (EAR). All studies included based on titles and abstracts advanced to the full-text evaluation phase. These studies were independently assessed by the same review team members, and any discrepancies were resolved through discussion with a third reviewer (EAR).
+
+Data extraction
+
+Four reviewers (ABP, YVC, FTCZ, SALV) were divided into two independent pairs. Each pair was assigned a portion of the included articles, from which they independently extracted the relevant data and entered them it into a Microsoft Excel spreadsheet. The extracted data included study characteristics (author, year of publication, country, study design, exposure measure, outcome), participant characteristics (age, gender, number of participants), and relative measures (crude and adjusted) with their confidence intervals obtained from the association between antiretroviral therapy in HIV patients and dental caries. Any disagreements were resolved through discussion or referral to a resolving reviewer (RAI).
+
+Study quality and certainty of evidence
+
+Two reviewers (RAI and HIAV) independently assessed the risk of bias of included studies using the Newcastle Ottawa tool for case–control studies and cohort studies, and the adapted version for cross-sectional studies [14]. This tool consists of three domains: selection, comparability, and exposure or outcome. For case–control studies, the selection domain allows for up to 4 stars, comparability up to 2 stars, and exposure or outcome up to 3 stars. In the case of the adapted tool for cross-sectional studies, up to 5 stars can be assigned in the selection domain, 2 in comparability, and 3 in exposure or outcome. Higher scores indicate higher study quality. Stars are awarded based on the answer to each element's question. Responses are graded with one or two stars, signifying a lower risk of bias for the assessed component. In cases of disagreement, a third reviewer acted as an arbitrator (ABP).
+
+Data synthesis and analysis
+
+The software Review Manager version 5.4.1 was used for the compilation and analysis of data from each study, using measures such as odds ratios and mean differences in random-effects models, providing 95% confidence intervals. Due to the observed heterogeneity among studies, random-effects models were applied, including inverse variance and Mantel–Haenszel methods for data analysis. To address heterogeneity beyond the I2 test and p-value, subgroup analyses were conducted based on study type, scale for measuring dental caries, comparator groups (HIV-negative or HIV-positive not yet receiving antiretroviral therapy), and type of therapy received (HAART versus standard ART). Additionally, heterogeneity was assessed using the I2 statistic, considering that heterogeneity may not be significant when I2 is below 40% [15]. Sensitivity analyses using fixed effects and other approaches were performed for studies with a risk of bias rating of 7 or more stars on the Newcastle–Ottawa Scale. It is noteworthy that a publication bias assessment was not performed due to the limited number of studies included in each analysis. The primary outcomes focused on the presence or absence of caries, measured numerically or categorically, in groups exposed and unexposed to antiretroviral therapy according to study design. Secondary outcomes included the mentioned subgroup analyses and proposed sensitivity analyses. In cases of missing data, and when necessary, we estimated the sample mean and standard deviation from sample size, median, interquartile range, or range, using the tool available at VassarStats (http://vassarstats.net). In situations where box plots were presented and means were reported without specifying the first or third quartile, we estimated these quartiles using AutoMeris (https://automeris.io), a computer vision-assisted software for extracting numerical data from data visualizations. Subsequently, with these data, we estimated the standard deviation.
+
+Certainty assessment
+
+The authors, through consensus, categorized the certainty of evidence for all reported outcomes and were categorized as high, moderate, low, or very low following the criteria of the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, using the GRADEpro software. The authors'consensus fully contextualized the rating of imprecision, risk of bias, inconsistency, and indirect evidence. We followed the GRADE guidance to communicate our findings and analyzed them using the GRADEpro GDT software (https://www.gradepro.org/).
+
+Results
+
+Search results
+
+We identified 1,374 records in the primary systematic search. After removing duplicates, 585 records were screened by title and abstract, of which 29 were reviewed in full text. In the expanded search in LILACS, 519 records were retrieved. However, none met the eligibility criteria. Finally, 17 met the inclusion criteria and were included in the analysis (Fig. 1). Excluded studies and reasons for their exclusion can be found in Table 2.Fig. 1 PRISMA flow diagram of the study selection process
+
+Table 2 Reason for exclusion of studies
+
+Author(s)	Year	Reason for exclusion	
+Madigan et al. [16]	1996	No antiretroviral therapy reported	
+Costa et al. [17]	1998	No antiretroviral therapy reported	
+Tofsky et al. [18]	2000	No antiretroviral therapy reported	
+Filho et al. [19]	2009	Not the target population	
+Kelly et al. [20]	2009	Antiretroviral therapy not mentioned	
+Alves et al. [21]	2009	Antiretroviral therapy not mentioned	
+Nittayananta et al. [22]	2010	Not the target population	
+Liberali et al. [23]	2013	Not the target population	
+Rezaei et al. [24]	2014	Not the target population	
+Mandal et al. [25]	2016	Antiretroviral therapy not mentioned	
+Griffen et al. [26]	2019	Not the target population	
+Berrezouga et al. [27]	2024	Not the target population	
+
+Characteristics of included studies
+
+In total, nine cross-sectional studies [28–36], six case–control studies [37–42], and two cohort studies [9, 43] were included. In terms of origin, the articles were from different locations: Brazil [9, 37–41], India [29, 30, 33, 35, 42], Nigeria [32, 36, 43], Cambodia [34], Uganda [28], and West Africa, specifically Mali, Senegal, and Ivory Coast [31]. Regarding patient age, most studies included children and adolescents in a broad age range [9, 29–31, 33, 34, 38, 40, 42, 43]. Four studies focused on children under 6 years old [32, 37, 39]. Although the study by O'Connell et al. [36] did not focus on children under 6, it included participants with a mean age of 6.58 ± 1.92 years. Ferreira et al. [41] included youth over 14 years old, while Gainneos et al. [35] studied children between 9 and 12 years. Of the seventeen included studies, one was multicentric, conducted in different countries (Mali, Senegal, and Ivory Coast), while the other studies were conducted in a single country: Brazil, India, Nigeria, Cambodia, and Uganda.
+
+Caries data
+
+Regarding caries data, all studies [9, 28–43] used validated World Health Organization (WHO) criteria; for example, DMFT/dmft (D: decayed teeth, M: teeth missing due to caries, F: filled teeth; in permanent and primary teeth, respectively).
+
+Type of antiretroviral therapy
+
+Concerning the type of antiretroviral therapy, Cerqueira et al. [38], Coker et al. [32], Akhigbe et al. [43], Ferreira et al. [41], O'Connell et al. [36], Andrade et al. [40], and Ponnam et al. [29] report a high percentage of patients on HAART. Other studies, such as Kumar et al. [42], Rwenyonyi et al. [28], and Oliscovicz et al. [9], compare the effects of HAART with s-ART, presenting groups that allow evaluation of both therapies. Some studies, such as Gainneos et al. [35], Kikuchi et al. [34], Shrikanth et al. [30], Thejashwini et al. [33], De Jesus et al. [39], Castro et al. [37], and Rajonson et al. [31], lack specific details on the type of therapy used, limiting the accuracy of comparisons.
+
+HIV diagnosis
+
+Regarding HIV diagnosis, most studies used standard serological tests such as ELISA and Western Blot to confirm infection [28, 29, 32, 34, 38, 40, 43]. Additionally, several studies used PCR tests for viral DNA detection regardless of age, although this method is particularly useful in children under 18 months, where maternal antibodies may interfere with serological test results [31, 32, 34, 36, 37]. Some studies followed specific criteria established by entities such as the CDC for HIV confirmation [37, 38, 43]. However, two studies did not specify the diagnostic methods used [30, 37].
+
+Data extraction for the meta-analysis
+
+Regarding result extraction, nine studies reported data to calculate the crude OR, and ten studies reported their means and standard deviations. Therefore, for the meta-analysis, we considered studies where crude ORs were obtained and studies that reported the mean value of dental caries in the exposure groups with their respective standard deviations (Table 3). Table 3 Characteristics of included studies
+
+Author(s)	Year	Country	Study type	Population	Number of participants (exposed or cases/controls)	Age	Caries index	Results
+OR (95% CI)b
+MD (95% CI)c
+CL (95% CI)d	Funding	
+Castro et al. [37]	2004	Brazil	Case–control	Children with HIV and HIV-negative	80 (40 VIH + and 40 VIH-)	2–5 years	dmft/dmfs	dmft: 1.52 (1.38–1.66)c
+
+dmfs mean: G1: 7.85, G2: 3.43
+
+	Blackwell Munksgaard	
+Cerqueira et al. [38]	2010	Brazil	Case–control	Children with HIV and siblings without HIV	105 (65 VIH + and 40 VIH-)	2–13 years	DMFT/dmft and number of cavitated carious teeth (CDT)	DMFT: 0.50 (− 0.13 – 1.13)c
+
+dmft: 2.20 (0.80–3.60)c
+
+	CNPq and FAPERJ	
+Rwenyonyi et al. [28]	2011	Uganda	Cross-sectional	Children with HIV	237 (118 with HAART and 119 without HAART)	1.5–12 years	DMFT/deft	DMFT: 2.06 (0.88–4.82)c
+
+deft: 1.09 (0.65–1.82)c
+
+	Sida/SAREC	
+Ponnam et al. [29]	2012	India	Cross-sectional	Children with HIV and HIV-negative	285 (95 VIH + with HAART, 95 VIH + without HAART, and 95 VIH-)	5–15 years	DMFT	VIH + with HAART vs. VIH + sin HAART: 1.27 (0.69–2.35)b VIH + with HAART vs. VIH-: 0.91 (0.50–1.65)b	None	
+Shrikanth et al. [30]	2015	India	Cross-sectional	Children with HIV and HIV-negative	234 (78 VIH + and 156 VIH-)	3–17 years	DMFT/dmft	VIH + vs. VIH-: 3.77 (1.41–10.10)b	None	
+Oliscovicz et al. [9]	2015	Brazil	Retrospective cohort	Children with HIV	111 (3 groups: G1: 51 with HAART, G2: 46 with ART, and G3: 14 without medication)	2–16 years	DMFT/deft	Mean DMFT, G1: 1.9, G2: 1.6, G3: 3.0
+
+Mean deft, G1: 3.2, G2: 2.8, G3: 3.8
+
+	None	
+De Jesus et al. [39]	2017	Brazil	Case–control	Children with HIV and HIV-negative	280 (140 VIH + and 140 VIH-)	2–5 years	dmft	dmft: 2.46 (1.91–3.01)c	Not reported	
+Andrade et al. [40]	2016	Brazil	Case–control	Children with HIV and HIV-negative	99 (33 VIH + and 66 VIH-)	7–15 years	DMFT/dmft and ICDAS	VIH + vs. VIH-: 3.15 (0.98–10.15)b
+
+DMFT: 1.34 (0.42–2.26)c
+
+	Not reported	
+Rajonson et al. [31]	2017	Ivory Coast, Mali, Senegal	Cross-sectional	Children with HIV and HIV-negative	838 (420 VIH + and 418 VIH-)	5–15 years	DMFT/deft
+
+DMFS/defs
+
+	VIH + vs. VIH-: 3.39 (2.41–4.76)b DMFT: 2.00 (1.93–2.07) ‡ deft: 2.00 (1.86–2.14)c DMFdefT: 2.00 (1.88–2.12)c DMFdefS: 5.00 (4.76–5.24)c
+
+Probability of zero affected surfaces:
+
+Age < 12 years:
+
+− 0.89 (− 1.53 to − 0.24)a,d
+
+Age ≥ 12 years:
+
+− 4.12 (− 7.43 to − 0.82)a,d
+
+	National Institutes of Health (NIH)	
+Coker et al. [32]	2018	Nigeria	Cross-sectional	Children with HI, HEU, HUU	335 (HI:100, HEU:105, HUU:130)	6–72 months	dft/DMFT and NIDCR	HI vs. HEU + HUU: 2.80 (1.35–5.81)b
+
+HI vs. HEU: 4.10 (1.45–11.57)b HI vs. HUU: 2.22 (0.99–4.97)b
+
+HI vs. HUU: 2.58 (1.04–6.40)b
+
+HI vs. HEU: 2.22 (0.99–4.97)a
+
+	Fogarty AIDS International Training and Research Program, NIH	
+Thejashwini et al. [33]	2018	India	Cross-sectional	Children with HIV and general HIV-negative population	100 (50 VIH + and 50 VIH-)	5–18 years	DMFT/dmft	DMFT:0.84 (− 0.32 – 2.00)c dmft:− 0.64 (− 1.90 – 0.62)c	Not reported	
+Ferreira et al. [41]	2018	Brazil	Case–control	Children with HIV and HIV-negative	70 (34 VIH + and 36 VIH-)	14–24 years	DMFT	Not reported	CNPq,, CAPES, FAPERJ	
+Kikuchi et al. [34]	2021	Cambodia	Cross-sectional	Children with HIV and HIV-negative	482 (328 VIH + and 154 VIH-)	3–15 years	DMFT/dmft	DMFT: 0.70 (− 0.03 – 1.43)c
+
+dmft: − 0.10 (− 1.18 – 0.98)c
+
+DMFT: 1.85 (1.14–3.01)a
+
+dmft: 0.65 (0.34–1.27)a
+
+	JSPS KAKENHI	
+Gainneos et al. [35]	2021	India	Cross-sectional	Children with HIV and HIV-negative	60 (30 VIH + and 30 VIH-)	9–12 years	DMFT	− 0.70 (− 1.36 – − 0.04)c	Self-funded	
+Akhigbe et al. [43]	2022	Nigeria	Prospective cohort	Children with HI, HEU, HUU	544 (HI:181, HEU:177, HUU:186)	4–11 years	dmft/DMFT and ICDAS	HI vs. HEU + HUU: 2.11 (1.41–3.17)b HI vs. HEU: 2.88 (1.71–4.84)b HI vs. HUU: 1.65 (1.04–2.61)b
+
+HI vs. HEU
+
+Caries in any dentition: 1.58 (0.96–2.59)a
+
+Caries in primary dentition: 1.41 (0.85–2.35)a
+
+Caries in permanent dentition: 3.44 (1.25–4.49)a
+
+	National Institutes of Health-NIDCR R01DE028154	
+Kumar et al. [42]	2024	India	Case–control	Children with HIV	150 (95 HAART and 75 HAART-naïve)	6–18 years	DMFT/dmft	DMFT: 2.02 (1.24–2.80)c
+
+dmft: 0.40 (− 0.38 –1.18)c
+
+	Not reported	
+O'Connell et al. [36]	2023	Nigeria	Cross-sectional	Children with HI, HEU, HUU	127 (HI: 49, HEU: 36, HUU: 42)	3–15 years	DMFT/dmft and ICDAS	HI vs. HEU + HUU: 2.14 (0.98–4.65)b HI vs. HEU: 3.46 (1.39–8.63)b HI vs. HUU 1.38 (0.56–3.41)b	National Institutes of Health (R01DE028154)	
+aAdjusted Measures
+
+bOR: Odds ratio
+
+cMD: Mean Difference
+
+dCL: logistic coefficient
+
+G1: receiving HAART (highly active antiretroviral therapy, ≥ 3 drugs)
+
+G2: receiving ART (antiretroviral therapy, ≤ 2 drugs)
+
+G3: not receiving antiretroviral medication
+
+NR: no record
+
+Risk of bias analysis of studies
+
+A risk of bias analysis was conducted on six case–control studies and two cohort studies using the Newcastle–Ottawa Scale (NOS), and on nine cross-sectional studies using a modified version of the NOS for cross-sectional studies. The included cross-sectional studies presented a significant risk of bias, primarily in the Selection domain, specifically in the items “Sample size” and “Statistical test.” The case–control studies also showed a risk of bias in the Selection domain, especially in the “Sample size” item. The cohort studies similarly exhibited a risk of bias in the Selection domain, specifically in the “Demonstration that the outcome of interest was not present at the start of the study.” This situation hinders the appropriate extrapolation of results, which should be taken into account when interpreting the findings of this review (Fig. 2). Nevertheless, there were no differences in the direction of the effect between the overall findings and those obtained when evaluating only studies with a low risk of bias (Fig. 3).Fig. 2 Risk of bias
+
+Fig. 3 Forest plot of sensitivity analysis with studies scoring 7 or more stars on the Newcastle–Ottawa Scale for risk of bias assessment
+
+Quantitative analysis: results synthesis
+
+Fifteen of the seventeen included studies [28–39, 41–43] provided data for the meta-analysis. The studies by Oliscovics et al. [9] and Ferreira et al. [40] were not included in the quantitative analysis. The first study was excluded because it only reported the mean value without dispersion measures such as standard deviation. The second study did not report numerical results. However, these studies reported conclusions indicating an association between HIV patients on ART and dental caries. The meta-analysis suggests significantly higher odds of dental caries in the HIV group receiving some form of antiretroviral treatment compared to the non-HIV group, in both cross-sectional studies (OR = 2.04, 95% CI 1.21–3.42, p = 0.007) and cohort study (OR = 2.11, 95% CI 1.41–3.17, p < 0.001). However, a case–control study reported no differences (OR = 3.15, 95% CI 0.98–10.15, p = 0.05) (Fig. 4). No statistically significant heterogeneity was detected between study designs (I2 = 0%, p = 0.79), and a similar result was obtained in the sensitivity analysis using a fixed-effects model (Fig. 5).Fig. 4 Forest plot comparing the presence of dental caries in individuals with HIV under antiretroviral therapy and individuals without HIV, according to study design
+
+Fig. 5 Forest plot of sensitivity analysis with fixed-effects model comparing dental caries in individuals with HIV under antiretroviral therapy and individuals without HIV, according to study design
+
+Subgroup analysis
+
+DMFT and dmft in HIV-positive patients (s-ART/HAART) vs. HIV-negative
+
+The subgroup analysis evaluated the caries indices (DMFT and dmft) in HIV-positive patients receiving antiretroviral therapy (s-ART/HAART) compared to HIV-negative individuals, differentiating the results by study design. For the DMFT index, cross-sectional studies (n = 4), with a total of 796 HIV-positive patients and 594 controls, revealed a mean difference (MD) of 0.60 (95% CI: − 0.53, 1.72), without statistical significance (p = 0.30) and with high heterogeneity (I2 = 93%). In case–control studies (n = 2), the MD was 0.85 (95% CI: 0.04, 1.66), showing significance (p = 0.04) and moderate heterogeneity (I2 = 54%), suggesting a possible association between HIV under ART and an increased DMFT index in this study type. In cross-sectional studies for the primary dentition index dmft/deft/dft, an MD of 0.92 (95% CI: − 0.09, 1.93) was observed, without significance (p = 0.08) but with high heterogeneity (I2 = 96%). Meanwhile, case–control studies showed a significant MD of 1.53 (95% CI: 1.39, 1.67) with no evidence of heterogeneity (I2 = 0%; p = 0.85), indicating that HIV under ART could be associated with a higher dmft index in this context (Fig. 6).Fig. 6 Forest plot of subgroup analysis comparing DMFT/dmft indices in individuals with HIV under treatment versus HIV-negative individuals, by study design
+
+DMFS and dmfs in HIV-positive patients (s-ART/HAART) vs. HIV-negative
+
+An additional subgroup analysis evaluated differences in the DMFS and dmfs indices between HIV-positive individuals under ART and HIV-negative individuals. For the DMFS index, mixed results were observed: in cross-sectional studies, a significant mean difference of 2.00 (95% CI: 1.54, 2.46) was reported, indicating a higher caries index in the HIV-positive group; whereas, in case–control studies, the difference was not significant, with a mean of 1.10 (95% CI: − 0.25, 2.45). Regarding the dmfs index, cross-sectional studies showed a significant difference with a mean of 4.00 (95% CI: 2.64, 5.36), and case–control studies found significant differences with a combined mean of 5.15 (95% CI: 2.20, 8.11), also suggesting a higher prevalence of caries in the HIV-positive group compared to controls. The test for subgroup differences was significant (Chi2 = 13.86, df = 3, p = 0.003), indicating potential variations in the impact of ART depending on the evaluated index and study design (Fig. 7).Fig. 7 Forest plot of subgroup analysis comparing DMFS/dmfs indices in HIV-treated individuals versus HIV-negative individuals, by study design
+
+Impact of HAART on dental caries
+
+In the subgroup analyses evaluating the impact of HAART on dental caries, a meta-analysis was first conducted on cross-sectional studies suggesting no significant differences in the probability of dental caries between the group of HIV-positive patients receiving HAART and those not receiving it. This was observed both in the total caries count with the DMFT index (OR = 1.29, 95% CI: 0.59–2.84, p = 0.53) and in the total count of carious teeth with the deft index (OR = 1.09, 95% CI: 0.65–1.82, p = 0.75) (Fig. 8). No statistically significant heterogeneity was detected among the caries indices used (I2 = 0%, p = 0.72), and the sensitivity analysis using a fixed-effects model showed consistent results (Fig. 9). Our primary analysis used a random-effects model, given the potential variability among different populations; however, a fixed-effects approach was used solely as a sensitivity analysis when heterogeneity was minimal (I2 = 0%) to confirm the consistency of our findings. Additionally, subgroups comparing the DMFT and dmft caries indices between HIV-positive patients under HAART and those without HAART were evaluated, yielding mixed results. In case–control studies for the DMFT index, a significant difference of 2.02 (95% CI: 1.24–2.80, p < 0.001) was reported, suggesting a higher DMFT index in the HAART group, while the analysis of the dmft index showed a non-significant mean difference of 0.66 (95% CI: − 0.26 – 1.58, p = 0.16) with low heterogeneity (I2 = 22%). The test for subgroup differences was significant (Chi2 = 4.88, p = 0.03, I2 = 79.5%), indicating potential variations in the impact of HAART depending on the evaluated index (Fig. 10). These results suggest a stronger association between HAART and the DMFT index, while the relationship with the dmft index is less conclusive, highlighting the need for additional studies and the importance of future research to confirm the observed relationship between antiretroviral therapy and caries indicators in HIV-positive patients.Fig. 8 Forest plot of subgroup analysis comparing the probability of total caries (DMFT and deft indices) in HIV-positive individuals under HAART versus those not under HAART (cross-sectional studies)
+
+Fig. 9 Forest plot of sensitivity analysis using a fixed-effects model comparing the probability of total caries (DMFT and deft indices) in HIV-positive individuals under HAART versus those not under HAART (cross-sectional studies)
+
+Fig. 10 Forest plot of subgroup analysis comparing DMFT and dmft indices in HIV-positive individuals under HAART versus those not under (case–control studies)
+
+Comparison with other control groups (HEU and HUU)
+
+An additional analysis compared the presence of caries in HIV-infected children under antiretroviral therapy (HI) with different control groups: HIV-exposed but uninfected children (HEU) and unexposed and uninfected children (HUU). In cross-sectional and cohort studies, HIV-positive children showed a higher probability of caries compared to HEU (OR = 3.73, 95% CI: 1.88–7.40; and OR = 2.88, 95% CI: 1.71–4.84, respectively). Compared to HUU, cross-sectional and case–control studies showed mixed results, with a caries probability of OR = 1.80 (95% CI: 0.98–3.28) and OR = 1.61 (95% CI: 1.02–2.56), respectively (Suppl Mat. 1).
+
+Certainty of evidence
+
+We assessed the certainty of the evidence based on the main outcomes, divided by study design. For all outcomes, we identified a very low level of certainty, mainly due to concerns in the domains of risk of bias, heterogeneity, indirect evidence, and imprecision. Due to our very low confidence in the results, the evidence remains uncertain for all outcomes. However, our findings suggest that exposure to HIV and antiretroviral therapy could increase the incidence of dental caries by 163 additional cases (range: 46 to 255 more) per 1,000 individuals in cross-sectional studies and by 145 additional events (range: 68 to 233 more) per 1,000 individuals in a single cohort study. No differences were observed in a single case–control study. Furthermore, exposure to antiretroviral therapy could increase the DMFT index by 0.85 points (range: 0.04 to 1.66 more) and the dmft index by 1.53 points (range: 1.39 to 1.67 more) per 1,000 individuals in case–control studies. In cross-sectional studies, no significant differences were found in the DMFT and dmft indices (Table 4). Table 4 Summary of finding
+
+Outcomes	№ of participants
+(studies)
+Follow-up	Certainty of the evidence
+(GRADE)	Relative effect
+(95% CI)	Anticipated absolute effects*	
+Risk Without HIV	Risk difference with HIV under therapy	
+Dental caries (cross-sectional studies)	2206
+
+(6 non-randomised studies)
+
+	⨁◯◯◯
+
+Very lowa,b,c
+
+	OR 2.04
+
+(2.21 to 3.42)
+
+	555 per 1,000	163 more per 1,000
+
+(46 more to 255 more)
+
+	
+Dental caries (case control studies)	33 cases 66 controls
+
+(1 non-randomised study)
+
+	⨁◯◯◯
+
+Very lowd,e
+
+	OR 3.15
+
+(0.98 to 10.15)
+
+	697 per 1,000	182 more per 1,000
+
+(4 fewer to 262 more)
+
+	
+Dental caries (cohort studies)	544
+
+(1 non-randomised study)
+
+	⨁◯◯◯
+
+Very lowe
+
+	OR 2.15
+
+(1.48 to 3.12)
+
+	190 per 1,000	145 more per 1,000
+
+(68 more to 233 more)
+
+	
+Dental caries (cross-sectional studies)
+
+assessed with: DMFT index
+
+	1390
+
+(4 non-randomised studies)
+
+	⨁◯◯◯
+
+Very lowa,c,f,g
+
+	-	-	MD 0.6 points higher
+
+(0.53 fewer to 1.72 higher)
+
+	
+Dental caries (case control studies)
+
+assessed with: DMFT index
+
+	204
+
+(2 non-randomised studies)
+
+	⨁◯◯◯
+
+Very lowc,h
+
+	-	-	MD 0.85 points higher
+
+(0.04 higher to 1.66 higher)
+
+	
+Dental caries (cross-sectional studies)
+
+assessed with: dmft index
+
+	1502
+
+(5 non-randomised studies)
+
+	⨁◯◯◯
+
+Very lowc,g,i,j
+
+	-	-	MD 0.92 points higher
+
+(0.09 fewer to 1.93 higher)
+
+	
+Dental caries (case control studies)
+
+assessed with: dmft index
+
+	185
+
+(2 non-randomised studies)
+
+	⨁◯◯◯
+
+Very low,c,h
+
+	-	-	MD 1.53 points higher
+
+(1.39 higher to 1.67 higher)
+
+	
+GRADE Working Group grades of evidence
+
+High certainty: we are very confident that the true effect lies close to that of the estimate of the effect
+
+Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
+
+Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
+
+Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
+
+CI Confidence interval, MD Mean difference, OR Odds ratio
+
+Explanations
+
+aWe downgraded the certainty of evidence by one level because half of the studies reported a higher risk of bias
+
+bThere is significant heterogeneity, confirmed by observing the forest plot and supported by the statistical value (I2 = 71%, p = 0.004)
+
+cWe downgraded by one level due to indirect evidence, as most of the studies partially align with the research question
+
+dWe downgraded by one level due to imprecision, considering that the study included a small sample size
+
+eWe downgraded by one level due to indirect evidence, as the study partially aligns with the research question
+
+fThere is significant heterogeneity, confirmed by observing the forest plot and supported by the statistical value (I2 = 93%, p = 0.00001)
+
+gWe downgraded by one level due to imprecision, as the pooled effect crossed the no-effect value
+
+hThere is significant heterogeneity, confirmed by observing the forest plot and supported by the statistical value (I2 = 54%, p = 0.14)
+
+iWe downgraded the certainty of evidence by one level because two of the three studies reported a higher risk of bias
+
+jThere is significant heterogeneity, confirmed by observing the forest plot and supported by the statistical value (I2 = 96%, p = 0.00001)
+
+kWe downgraded by one level due to indirect evidence, as the studies partially align with the research question
+
+lWe downgraded by one level due to imprecision, considering that the studies included small sample sizes
+
+*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
+
+Discussion
+
+The main objective of this systematic review and meta-analysis was to evaluate the association between ART and dental caries in children and adolescents with HIV. Our findings revealed a significantly higher probability (OR 2.15) of dental caries in those under some form of antiretroviral therapy compared to individuals without HIV. This result reflects the diversity of findings reported in the studies included in the primary meta-analysis: four studies reported a higher risk of caries in children with HIV under antiretroviral therapy [30–32, 43], while another four did not find a significant association [29, 34, 36, 40].
+
+The higher prevalence of dental caries in HIV patients under ART may be attributed to multiple factors. First, the systemic condition of HIV may reduce CD4 + T lymphocyte levels, leading to immunosuppression that increases the risk of colonization by cariogenic bacteria (6). Previous studies have reported an association between immunosuppression and greater severity of caries [37–40]. However, some authors, such as Shrikanth et al. [29], did not find a direct correlation between CD4 + count and dental caries, suggesting that other factors may contribute to this relationship.
+
+Socioeconomic factors also play a crucial role. Souza et al. [17] reported that the frequency of caries was 21% higher in individuals with a family income equal to or lower than the minimum wage. This indicates that unfavorable economic conditions, commonly associated with HIV patients, may influence the prevalence of caries due to limitations in access to dental health services and oral hygiene education.
+
+Furthermore, the immunological dysfunction associated with HIV may affect the concentration of salivary immunoglobulin A (IgA). Studies have found lower levels of salivary IgA in HIV-positive children, which could increase susceptibility to dental caries [25, 35]. However, it is important to consider that salivary IgA levels may also be affected by psychological factors such as stress and malnutrition [23, 35].
+
+Antiretroviral therapy itself may influence oral health. Some studies suggest that ART may reduce salivary flow, a protective factor against caries [21]. Nevertheless, there is contradictory evidence, such as the study by Kikuchi et al. [34], which observed higher salivary flow in HIV-positive children. This suggests that the effect of ART on salivary flow may be modulated by other factors, such as dietary habits and diet.
+
+Another aspect to consider is the high sugar content in pediatric formulations of antiretroviral medications. Syrups and suspensions with high sugar content can be fermented by oral bacteria, lowering intraoral pH and increasing the risk of caries [9].
+
+This review also highlights the importance of regular follow-ups and preventive strategies in pediatric patients with HIV. Dental caries not only affects oral health but can also have systemic implications, impacting patients'quality of life and nutritional status [20].
+
+Several studies have underscored the importance of adjusting for confounding variables when assessing the relationship between HIV infection, antiretroviral therapy, and dental caries. Coker et al. [32] found that HIV-infected children had a significantly higher risk of caries compared to uninfected children, with the association remaining significant after adjusting for sex, age, duration of breastfeeding, and membrane rupture (adjusted OR 2.58; 95% CI 1.04–6.40; p = 0.04). Similarly, Rajonson et al. [31] observed that the increased caries prevalence in HIV-positive children persisted in adjusted analyses accounting for factors like age, sex, sugary drink consumption, oral hygiene index, and tooth brushing frequency (logistic coefficient: –0.89; 95% CI –1.53 to –0.24; p = 0.007 for children under 12 years). Kikuchi et al. [34] reported that HIV-positive status was significantly associated with higher DMFT scores in permanent dentition even after adjusting for age, gender, socioeconomic status, BMI, and school functioning (adjusted OR 1.85; 95% CI 1.14–3.01; p < 0.05), while no significant association was found in deciduous dentition. Akhigbe et al. [43] also demonstrated that the higher prevalence of caries in HIV-infected children remained significant in adjusted analyses for permanent dentition (adjusted OR 3.44; 95% CI 1.25–9.49; p < 0.05) but not for deciduous dentition. These findings reinforce the results of our systematic review, highlighting that the association between HIV infection, antiretroviral therapy, and increased risk of dental caries in permanent teeth remains robust even after controlling for potential confounders.
+
+The subgroup analysis in this meta-analysis shows that, in cross-sectional studies, there are no significant differences in the prevalence of caries between HIV-positive patients under HAART and those not receiving this therapy. This suggests that the influence of HAART on dental health is not determinant in studies of this design and highlights the importance of additional or contextual factors that could moderate this relationship.
+
+The heterogeneity observed in this meta-analysis can be attributed to various factors, including differences in study designs (cross-sectional, case–control, and cohort), variability in caries diagnostic criteria (DMFT/dmft, ICDAS, etc.), the geographical and sociocultural diversity of the populations studied (Latin America, Africa, and Asia), and the wide age range (from early childhood to adolescence). In addition, some studies did not adequately control for socioeconomic factors or provide detailed data on the type, duration, and adherence to antiretroviral therapy, which makes it difficult to establish more homogeneous comparisons. To address this variability, random-effects models were used, and subgroup analyses were conducted, allowing for a more precise estimation of the overall association and exploration of potential sources of heterogeneity. Nevertheless, these methodological and contextual differences explain, at least in part, the variability in the results. Future research with standardized diagnostic criteria, tighter control of sociodemographic factors, and narrower age ranges could help reduce heterogeneity and provide greater clarity about the relationship between antiretroviral therapy and caries in children and adolescents with HIV.
+
+When analyzed by study type, case–control studies show a potentially significant association between ART and an increase in the DMFT caries index, suggesting that this study design might better capture individual variations or factors associated with prolonged treatment. In contrast, cross-sectional studies present considerable heterogeneity, indicating that differences in the studied populations and methodology may influence the accuracy of the results.
+
+The caries index for primary dentition (dmft) did not show statistically significant differences in cross-sectional studies; however, case–control studies revealed a more consistent association between ART and an increase in this index. This indicates that the relationship between HAART and caries may depend on both the study design and the specific indices used. Together, the findings highlight the complexity of the interaction between ART and dental health and the need to consider individual and design variations when interpreting the magnitude of this relationship.
+
+The results of this systematic review and meta-analysis will benefit multiple groups, including pediatric patients with HIV, their families, health professionals, and public health policymakers. Although previous systematic reviews have explored various aspects of oral health in patients with HIV [11, 12], they have not adequately considered the influence of different subgroups, which can vary according to study design, type of treatment, caries index evaluated, or control group. Moreover, they have not incorporated structured approaches, such as Summary of Findings (SoF) tables, to synthesize the quality of the evidence. By addressing these gaps, our review provides a more comprehensive assessment of how ART influences the incidence and severity of dental caries in children and adolescents with HIV.
+
+Study limitations
+
+Despite the rigorous methodology employed, our study presents some limitations. First, the inclusion of cross-sectional studies restricts the ability to establish causal relationships, as these designs only allow for the observation of associations at a specific point in time. Additionally, the included case–control studies may be subject to recall bias, which could compromise the validity of the associations.
+
+Variability in the diagnostic criteria for dental caries (DMFT/dmft, ICDAS, among others), differences in antiretroviral therapy regimens, and inconsistencies in data reporting across studies may have contributed to the observed heterogeneity. Notably, many studies lacked detailed information on adherence to ART, treatment duration, and prior dental history, key factors that could influence caries development.
+
+The risk of bias assessment revealed that several studies had limitations in representativeness and sample size, which may affect the generalizability of the results. Furthermore, confounding factors such as socioeconomic status could not be controlled in all studies, potentially influencing the observed association between ART and dental caries.
+
+Finally, the absence of longitudinal studies prevents a deeper understanding of the temporal relationship between the initiation of ART and the development of dental caries. It is important to note that most of the included studies were conducted in specific geographic regions (Latin America, Africa, and Asia), where differences in healthcare infrastructure, nutritional status, and oral health policies may limit the applicability of our findings to other populations. Therefore, caution should be exercised when extrapolating these results to high-income settings, where factors such as access to dental services, cultural practices, and prevention policies may significantly influence this association. Conducting prospective studies is essential to determine whether ART is a causal factor in the increased incidence of dental caries.
+
+Recommendations
+
+The relevance of this review lies in the evidence that HIV under antiretroviral therapy and dental caries could be interrelated. Therefore, we propose the following actions:Awareness and education: It is essential to raise awareness among healthcare professionals about the impact of ART on the oral health of HIV-positive children and adolescents. The implementation of specific educational programs can promote comprehensive care that considers both systemic and oral health.
+
+Preventive interventions and integration into health programs: The implementation of preventive and timely dental interventions is essential to prevent the progression of caries and facilitate its treatment in patients with HIV under antiretroviral therapy. Untreated caries can cause pain and affect quality of life, worsening the overall health status. Therefore, it is recommended to systematically integrate preventive care and dental interventions into national health programs for people with HIV, regardless of the establishment's category. In regions with limited human resources, it is suggested that a member of the healthcare team receive specific training from a dentist, whether a pediatric dentist or general dentist, for the early identification of oral health issues. Furthermore, it is imperative to reassess existing regulations to ensure an integral and effective approach to oral health care for this population, using the Technical Health Standard for Comprehensive Care of Children and Adolescents with HIV Infection in Peru [44] as a reference.
+
+Specific dental interventions: We recommend including specific dental interventions as part of national HIV prevention strategies. This involves not only oral evaluation but also the provision of necessary preventive and therapeutic treatments, such as fluoride applications, pit and fissure sealants, and sugar-free medication protocols where feasible.
+
+Conclusions
+
+Our findings suggest a possible association between antiretroviral therapy and an increased likelihood of dental caries in children and adolescents with HIV. However, due to the observational nature of the included studies and the methodological limitations discussed, these results should be interpreted with caution. The heterogeneity in study designs, diagnostic criteria, and population characteristics highlights the need for more standardized and high-quality research in this field.
+
+Longitudinal studies are required to establish a clearer understanding of the relationship between ART and dental caries, as well as to explore the potential underlying biological and behavioral mechanisms. Until more evidence is available, healthcare professionals should consider oral health as a relevant aspect of HIV management and promote preventive dental care for children and adolescents receiving ART.
+
+Supplementary Information
+
+Supplementary Material 1
+
+Appendix
+
+PRISMA checklist
+
+Section and Topic	Item #	Checklist item	Location where item is reported	
+TITLE		
+Title	1	Identify the report as a systematic review.	First page 1	
+ABSTRACT		
+Abstract	2	See the PRISMA 2020 for Abstracts checklist.	 2, 3	
+INTRODUCTION		
+Rationale	3	Describe the rationale for the review in the context of existing knowledge.	3, 4	
+Objectives	4	Provide an explicit statement of the objective(s) or question(s) the review addresses.	5	
+METHODS		
+Eligibility criteria	5	Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses.	6	
+Information sources	6	Specify all databases, registers, websites, organisations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted.	6, 7	
+Search strategy	7	Present the full search strategies for all databases, registers and websites, including any filters and limits used.	6, 7 (Table 1)	
+Selection process	8	Specify the methods used to decide whether a study met the inclusion criteria of the review, including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools used in the process.	8	
+Data collection process	9	Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process.	9, 10	
+Data items	10a	List and define all outcomes for which data were sought. Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses), and if not, the methods used to decide which results to collect.	8	
+10b	List and define all other variables for which data were sought (e.g. participant and intervention characteristics, funding sources). Describe any assumptions made about any missing or unclear information.	8	
+Study risk of bias assessment	11	Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process.	8	
+Effect measures	12	Specify for each outcome the effect measure(s) (e.g. risk ratio, mean difference) used in the synthesis or presentation of results.	9, 10	
+Synthesis methods	13a	Describe the processes used to decide which studies were eligible for each synthesis (e.g. tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)).	7	
+13b	Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions.	8	
+13c	Describe any methods used to tabulate or visually display results of individual studies and syntheses.	9, 10	
+13 d	Describe any methods used to synthesize results and provide a rationale for the choice(s). If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used.	9, 10	
+13e	Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression).	9, 10	
+13f	Describe any sensitivity analyses conducted to assess robustness of the synthesized results.	9, 10	
+Reporting bias assessment	14	Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases).	9, 10	
+Certainty assessment	15	Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome.	10	
+RESULTS		
+Study selection	16a	Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram.	10 (Fig.1)	
+16b	Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.	10 (Table 2)	
+Study characteristics	17	Cite each included study and present its characteristics.	11 (Table 3)	
+Risk of bias in studies	18	Present assessments of risk of bias for each included study.	13 (Fig. 2, Fig. 3)	
+Results of individual studies	19	For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots.	13,14 (Fig. 4, Fig. 5)	
+Results of syntheses	20a	For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies.	13 (Fig. 2, Fig. 3)	
+20b	Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect.	14 (Fig. 5)	
+20c	Present results of all investigations of possible causes of heterogeneity among study results.	14 (Fig. 5)	
+20 d	Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.	14 (Fig. 5)	
+Reporting biases	21	Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed.	-	
+Certainty of evidence	22	Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed.	17 (Table 4)	
+DISCUSSION		
+Discussion	23a	Provide a general interpretation of the results in the context of other evidence.	18, 19, 20, 21, 22	
+23b	Discuss any limitations of the evidence included in the review.	22, 23	
+23c	Discuss any limitations of the review processes used.	22, 23	
+23 d	Discuss implications of the results for practice, policy, and future research.	22	
+OTHER INFORMATION		
+Registration and protocol	24a	Provide registration information for the review, including register name and registration number, or state that the review was not registered.	5	
+24b	Indicate where the review protocol can be accessed, or state that a protocol was not prepared.	PROSPERO (CRD42024605937)	
+24c	Describe and explain any amendments to information provided at registration or in the protocol.	-	
+Support	25	Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors in the review.	26	
+Competing interests	26	Declare any competing interests of review authors.	26	
+Availability of data, code and other materials	27	Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review.	26	
+From:  Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. 10.1136/bmj.n71
+
+Abbreviations
+
+HIV Human Immunodeficiency Virus
+
+ART Antiretroviral Therapy
+
+S-ART Standard Antiretroviral Therapy
+
+HAART Highly Active Antiretroviral Therapy
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+PROSPERO International Prospective Register of Systematic Reviews
+
+PECO Population, Exposure, Comparator, Outcome
+
+DMFT/dmft Decayed, Missing, Filled Teeth (permanent and primary teeth)
+
+WHO World Health Organization
+
+NOS Newcastle Ottawa Scale
+
+CI Confidence Interval
+
+OR Odds Ratio
+
+GRADE Grading of Recommendations, Assessment, Development, and Evaluations
+
+CDC Centers for Disease Control and Prevention
+
+ICDAS International Caries Detection and Assessment System
+
+PCR Polymerase Chain Reaction
+
+NIH National Institutes of Health
+
+NIDCR National Institute of Dental and Craniofacial Research
+
+ELISA Enzyme-Linked Immunosorbent Assay
+
+Acknowledgements
+
+We sincerely thank Michael Sciaudone for his invaluable support and suggestions during the review of this manuscript. We are grateful to Universidad Continental for covering the journal’s publication fee.
+
+Authors’ contributions
+
+R.A-I conceived the study. All authors contributed to the study design. R.A-I and A.B-P planned, supervised, and validated the work. R.A-I performed the literature search and removed duplicate records. R.A-I and A.H-C carried out the study selection. A.B-P, Y.V-C, F.T.C-Z, and S.A.L-V extracted data from the included articles. R.A-I and H.I.A-V assessed the quality of the studies. R.A-I, A.B-P, Y.V-C, E.A-R, and F.T.C-Z analyzed the results and drafted the manuscript. RAI created the tables and figures. R.A-I, A.B-P, Y.V-C, A.H-C, F.T.C-Z, S.A.L-V, E.A-R, and H.I.A-V critically reviewed, approved, and took responsibility for the content of the manuscript.
+
+Funding
+
+No funding was received for this study.
+
+Data availability
+
+The dataset supporting the conclusions of this article is included within the article. However, additional information can be requested from the corresponding author upon reasonable inquiry.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Not applicable.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
+1. World Health Organization. HIV/AIDS Fact Sheet. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/hiv-aids. Accessed 10 Oct 2024.
+2. UNAIDS. Global HIV & AIDS statistics—Fact sheet. Geneva: UNAIDS; 2024. Available from: https://www.unaids.org/en/resources/fact-sheet. Accessed 10 Oct 2024.
+3. Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008; 359(21):2233–44. 10.1056/NEJMoa0800971.10.1056/NEJMoa0800971 PMC2950021 19020325
+4. Belkaid Y Hand TW Role of the microbiota in immunity and inflammation Cell 2014 157 1 121 141 10.1016/j.cell.2014.03.011 24679531 PMC4056765
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+5. Imahashi M Ode H Kobayashi A Nemoto M Matsuda M Hashiba C Hamano A Nakata Y Mori M Seko K Impact of long-term antiretroviral therapy on gut and oral microbiotas in HIV-1-infected patients Sci Rep 2021 11 1 960 10.1038/s41598-020-80247-8 33441754 PMC7806981
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+Ponnam SR, Srivastava G, Theruru K. Oral manifestations of human immunodeficiency virus in children: An institutional study at highly active antiretroviral therapy centre in India. J Oral Maxillofac Pathol. 2012;16(2):195–202. 10.4103/0973-029X.98499.22923890 10.4103/0973-029X.98499 PMC3424934
+30. Shrikanth M, Kumar A, Gangakhedkar R. Oral Health Status and Treatment Needs of Institutionalized HIV Positive and Non- HIV Positive Children and Adolescents between 3 To 17 Years of Age in Pune Maharashtra, India: A Comparative Study. Ind J Pre Clin Dent Res. 2015;3(1):92–98. Available from: http://www.ijocrweb.com/pdf/2015/January-March/9228_Review%20Paper.pdf.
+31. Rajonson N, Meless D, Ba B, Faye M, Diby JS, N'zore S, Datté S, Diecket L, N'Diaye C, Aka EA, et al. High prevalence of dental caries among HIV-infected children in West Africa compared to uninfected siblings. J Public Health Dent. 2017;77(3):234–243. 10.1111/jphd.12203.10.1111/jphd.12203 28233316
+32. Coker M El-Kamary SS Enwonwu C Blattner W Langenberg P Mongodin E Akhigbe P Obuekwe O Omoigberale A Charurat M Perinatal HIV Infection and Exposure and Their Association With Dental Caries in Nigerian Children Pediatr Infect Dis J 2018 37 1 59 65 10.1097/INF.0000000000001702 28746260 PMC5725234
+Coker M, El-Kamary SS, Enwonwu C, Blattner W, Langenberg P, Mongodin E, Akhigbe P, Obuekwe O, Omoigberale A, Charurat M. Perinatal HIV Infection and Exposure and Their Association With Dental Caries in Nigerian Children. Pediatr Infect Dis J. 2018;37(1):59–65. 10.1097/INF.0000000000001702.28746260 10.1097/INF.0000000000001702 PMC5725234
+33. Thejashwini E, Vivek K, Sushmita D, Sreedevi A, Megha. A Study on Dental Caries Status among 5–18 Years HIV And Healthy Children-A Comparative Study. IOSR-JDMS. 2018;17(1):1–6. 10.9790/0853-1701130106.
+34. Kikuchi K Yi S Yasuoka J Tuot S Okawa S Murayama M Yem S Chhoun P Eng S Huot C Morokuma S Oral health among HIV-positive and HIV-negative children in Phnom Penh, Cambodia: a cross-sectional study BMJ Paediatr Open 2021 5 1 e000992 10.1136/bmjpo-2020-000992 33782657 PMC7957132
+Kikuchi K, Yi S, Yasuoka J, Tuot S, Okawa S, Murayama M, Yem S, Chhoun P, Eng S, Huot C, Morokuma S. Oral health among HIV-positive and HIV-negative children in Phnom Penh, Cambodia: a cross-sectional study. BMJ Paediatr Open. 2021;5(1):e000992. 10.1136/bmjpo-2020-000992.33782657 10.1136/bmjpo-2020-000992 PMC7957132
+35. Gainneos PD Vasaviah SK Duraisamy V Krishnan R John JB A Comparative Evaluation of the Levels of Salivary IgA in HIV Affected Children and the Children of the General Population within the Age Group of 9–12 Years – A Cross-Sectional Study Int J Cur Res Rev 2021 13 5 61 65 10.31782/IJCRR.2021.SP142
+Gainneos PD, Vasaviah SK, Duraisamy V, Krishnan R, John JB. A Comparative Evaluation of the Levels of Salivary IgA in HIV Affected Children and the Children of the General Population within the Age Group of 9–12 Years – A Cross-Sectional Study. Int J Cur Res Rev. 2021;13(5):61–5. 10.31782/IJCRR.2021.SP142.
+36. O'Connell LM Mann AE Osagie E Akhigbe P Blouin T Soule A Obuekwe O Omoigberale A Burne RA Coker MO Supragingival mycobiome of HIV-exposed-but-uninfected children reflects a stronger correlation with caries-free-associated taxa compared to HIV-infected or uninfected children Microbiol Spectr 2023 11 6 e0149123 10.1128/spectrum.01491-23 37874172 PMC10715047
+O’Connell LM, Mann AE, Osagie E, Akhigbe P, Blouin T, Soule A, Obuekwe O, Omoigberale A, Burne RA, Coker MO, et al. Supragingival mycobiome of HIV-exposed-but-uninfected children reflects a stronger correlation with caries-free-associated taxa compared to HIV-infected or uninfected children. Microbiol Spectr. 2023;11(6):e0149123. 10.1128/spectrum.01491-23.37874172 10.1128/spectrum.01491-23 PMC10715047
+37. Castro GF Souza IP Lopes S Stashenko P Teles RP Salivary IgA to cariogenic bacteria in HIV-positive children and its correlation with caries prevalence and levels of cariogenic microorganisms Oral Microbiol Immunol 2004 19 5 281 288 10.1111/j.1399-302x.2004.00152.x 15327638
+Castro GF, Souza IP, Lopes S, Stashenko P, Teles RP. Salivary IgA to cariogenic bacteria in HIV-positive children and its correlation with caries prevalence and levels of cariogenic microorganisms. Oral Microbiol Immunol. 2004;19(5):281–8. 10.1111/j.1399-302x.2004.00152.x.15327638 10.1111/j.1399-302x.2004.00152.x
+38. Cerqueira DF Portela MB Pomarico L de AraújoSoares RM de Souza IP Castro GF Oral Candida colonization and its relation with predisposing factors in HIV-infected children and their uninfected siblings in Brazil: the era of highly active antiretroviral therapy J Oral Pathol Med 2010 39 2 188 194 10.1111/j.1600-0714.2009.00857.x 20040023
+Cerqueira DF, Portela MB, Pomarico L, de AraújoSoares RM, de Souza IP, Castro GF. Oral Candida colonization and its relation with predisposing factors in HIV-infected children and their uninfected siblings in Brazil: the era of highly active antiretroviral therapy. J Oral Pathol Med. 2010;39(2):188–94. 10.1111/j.1600-0714.2009.00857.x.20040023 10.1111/j.1600-0714.2009.00857.x
+39. de Jesus MA, de Aguiar Ribeiro A, Lima PM, Chianca T, de Souza IP, de Araujo Castro GF. Influence of Caregiver's Sociodemographic Background on the Oral Health Status and Care of HIV-infected Children. J Dent Child (Chic). 2017;84(1):16–21. Available from: https://pubmed.ncbi.nlm.nih.gov/28387185/.28387185
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Med Internet Res
+Journal ID: J Med Internet Res
+NLM Journal ID: 100959882
+Journal ID: JMIR
+
+Journal of Medical Internet Research
+
+ISSN: 1439-4456
+EISSN: 1438-8871
+Publisher: JMIR Publications Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12096025
+PMID: 40334268
+DOI: 10.2196/57129
+Article ID: v27i1e57129
+Article version: 1
+Subjects: Review, Review
+
+Telehealth Interventions in Pharmacy Practice: Systematic Review of Reviews and Recommendations
+
+Mavragani Amaryllis
+Tan Doreen
+Pourasad Mohammad Hossein
+Dinh Dai
+Amresh Ashish
+Chong Rachel Lai Kay BSc 1 https://orcid.org/0009-0006-5199-7228
+Chan Andrew Siang Ee BSc 1 https://orcid.org/0009-0007-7365-9219
+Chua Crystal Min Siu BSc, MSc https://orcid.org/0000-0001-6057-3247 2 MOH Office for Healthcare Transformation 1 North Buona Vista Link #09-02, Elementum Singapore, 139691 Singapore 65 81394941 crystal.chua@moht.com.sg
+
+Lai Yi Feng DrPH, MPH, BSc 2 https://orcid.org/0000-0002-0475-7479
+1 NUS Pharmacy and Pharmaceutical Sciences Singapore Singapore
+2 MOH Office for Healthcare Transformation Singapore Singapore
+Corresponding Author: Crystal Min Siu Chua crystal.chua@moht.com.sg
+Publication date: 2025
+Electronic publication date: 2025 May 7
+Volume: 27
+Electronic Location ID: e57129
+Received 2024 Feb 6; Revision requested 2024 Sep 17; Revised 2024 Oct 6; Accepted 2025 Jan 29
+Copyright: ©Rachel Lai Kay Chong, Andrew Siang Ee Chan, Crystal Min Siu Chua, Yi Feng Lai. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 07.05.2025.
+Copyright year: 2025
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: pharmacy, telehealth interventions, systematic review of reviews, recommendations, telehealth, telepharmacy, pharmacy practice, innovation, systematic review, Singapore, Intervention, service, literature, database, teleconsultation, telemonitoring, telecollaboration, telesupport, meta-analysis, telephone, fax, electronic messaging, electronic records, video conferencing
+
+Ÿ==============================Ÿ
+Background
+
+Pharmaceutical care has expanded, with telehealth playing a key role, especially during the COVID-19 pandemic. Despite global growth, existing reviews focus on specific settings or conditions, highlighting the need for broader research on public health topics and comparative studies to evaluate the effectiveness, preferences, and cost of telehealth interventions in pharmacy practice.
+
+Objective
+
+The aim of this study was to unify existing literature on the impact of telehealth on future pharmacy practice and to analyze those already implemented in current pharmacy practice, with the objective of providing recommendations.
+
+Methods
+
+The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework was used to guide this review. In total, 4 databases were searched for relevant studies: PubMed, CINAHL, Web of Science, and Cochrane Library. Title, abstract, and full-text screening was performed, and 18 reviews met the selection criteria. The search period was from August 1, 2012, to December 22, 2024. The quality of the reviews was assessed using a 5-point Likert scale and a GRADE-CERQual scale.
+
+Results
+
+Based on the identified reviews, telehealth interventions were categorized into teleconsultation, telemonitoring, telecollaboration, and telesupport. Teleconsultation was the most frequently used. Telephones were most common in teleconsultations and telemonitoring, while mobile, web, or computer applications were most frequent in telesupport. A combination of methods was most used to facilitate telecollaboration, such as telephone, fax, electronic messaging, shared electronic records, and videoconferencing. The identified reviews were evaluated by health outcomes, hospital readmission rates, patient safety, adherence, satisfaction, pharmacist shortage, and quality and access to care. The use of telehealth in pharmacy has generally seen an improvement in overall outcomes compared to traditional pharmacy practice. Our results show a strong push to integrate telehealth into future pharmacy practice, with the United States leading the way in adoption, demonstrating increased care access, quality, and patient safety. In Singapore, telephone consultations have been commonly used in hospitals, though community settings lack widespread adoption. However, the growing digital literacy of older adults and innovations like chatbots and telemonitoring present opportunities to expand telehealth services. To align with this shift, pharmacy education should invest in enhancing formative training by incorporating telehealth training, ensuring future pharmacists are prepared for this evolving practice, applicable to regions with similar contexts.
+
+Conclusions
+
+Telehealth has shown promise in improving overall outcomes in pharmacy practice. While many countries have made strides, particularly in hospital settings, there remains an opportunity for greater adoption in community health care, driven by innovations like telemonitoring and digital literacy among older adults. The findings from this study can be used to inform future implementation of telehealth interventions in pharmacy in Singapore and other regions or cities with similar contexts.
+
+Introduction
+
+Pharmaceutical care is an essential component of the health care system and has seen a significant expansion of roles and responsibilities in recent years to accommodate the evolving demands of patients [1]. Delivery of pharmaceutical care has been moving toward a more telehealth-focused approach, with pharmacists depending on communication technologies to communicate with both patients and other health care professionals, especially with the onset of the COVID-19 pandemic [2]. As such, many countries, including Singapore, have recognized the need to incorporate telehealth solutions to manage patient care, particularly considering pandemic-related pressures on health care systems. Telehealth is broadly defined as the use of communication technologies to deliver health care services remotely, encompassing a variety of services such as teleconsultations, remote monitoring, and virtual health support [2].
+
+In 2019, Singapore’s Multi-Ministry Taskforce implemented telehealth to prevent overloading critical primary and secondary health care institutions during the pandemic. Considering these challenges, the Taskforce launched a series of initiatives aimed at reducing the strain on hospitals and clinics by expanding the use of telehealth. This proactive shift toward telemedicine allowed health care providers to continue offering essential services while maintaining social distancing measures and reducing the physical presence of patients in health care settings. As part of this initiative, the Telemedicine Allocation and Reconciliation System was also used to manage teleconsultation assignments to a suitable telemedicine provider, storing patient records and flagging patients who require additional care [3]. Additionally, the Ministry of Health has launched a regulatory sandbox initiative, providing impetus to startups to explore telemedicine with the support from the ministry. Platforms generated because of this initiative, such as MyDoc and DoctorAnywhere, have enabled greater access to teleconsultations, especially during the COVID-19 pandemic [4]. These telehealth platforms, alongside the regulatory sandbox, empowered not only private sector innovation but also allowed public health care institutions to explore new ways of delivering care.
+
+Globally, similar trends have emerged, with many countries launching regulatory frameworks, innovation hubs, and collaborations with tech startups to foster telemedicine adoption. For example, in the United States, teleconsultations were used in 85% of major teaching hospitals, 49% of microrural hospitals, and 54% of nonprofit hospitals [5]. Similarly in India, an initiative by the Ministry of Health and Family Welfare launched digital outpatient services for all Indian citizens via the national Teleconsultation Service, eSanjeevaniOPD, expanding access to free health services to all its citizens [6]. The adoption of telehealth solutions has not only been a response to COVID-19 but also transformed how health care services are delivered [2]. As health care systems globally grapple with increasing patient demands, telehealth presents a sustainable solution to address gaps in care delivery, particularly in underserved and rural areas where access to health care professionals and pharmacists may be limited. As such, telehealth has become a cornerstone of modern pharmaceutical care, providing pharmacists with the tools to extend their services beyond traditional settings and reach patients wherever they are.
+
+The shift toward telehealth in pharmacy practice has generated a growing body of literature and reviews [2]. However, many of these reviews tend to focus on specific settings or modes of telehealth, such as teleconsultations or telepharmacy in clinical environments. Additionally, many studies are limited to specific disease conditions and cover a limited range of public health topics, such as medication adherence. Hence, evaluation of a broader range of public health topics is required to provide a more holistic assessment of the benefits of telehealth interventions in the pharmacy setting. Moreover, further research in blinded comparable studies to investigate preference, appropriateness, and cost-effectiveness of telehealth interventions is required, which most current literature does not address.
+
+To address these gaps, it is crucial to unify the currently available evidence regarding the four main telehealth domains: (1) teleconsultation, (2) telecollaboration, (3) telesupport, and (4) telemonitoring; their use in a variety of settings to identify future directions that pharmacy can possibly work toward [7]. Furthermore, there is a need for a more robust consolidation of existing information that explores the appropriateness of telehealth interventions in pharmacy practice that have been largely overlooked in existing research.
+
+This systematic review of reviews was conducted to unify existing literature concerning the impact of telehealth on future pharmacy practice. The research question is as follows: What are the effective telehealth interventions in pharmacy practice, and what recommendations can be made? We hope to analyze the various telehealth interventions that have been implemented in current pharmacy practice and theorize recommendations on how these interventions may be applied.
+
+Methods
+
+Overview
+
+The systematic review of reviews was conducted to synthesize existing evidence across multiple studies, offering a comprehensive understanding of a topic and highlighting trends and gaps in the literature. The methodology of this review was based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) [8].
+
+Search Strategy
+
+Standardized search terms will be used on 4 databases, PubMed, Cochrane Library, CINAHL, and Web of Science, from August 1, 2012, to December 22, 2024. The search terms were developed based on the keywords in our research question. These included telehealth and pharmacy practice, which were used to develop the search strategy: (tele* OR ehealth* OR digital*) and (pharmacy OR pharmacies OR pharmacist*) were used to search all the databases. MeSH (Medical Subject Headings) terms for “Telemedicine,” “Pharmacy,” “Pharmacies,” and “Pharmacists” were used in addition to the basic search terms in PubMed and Cochrane Library. “Telehealth+”, “Pharmacy Service+”, “Pharmacy, Retail,” and “Pharmacists” were additional MeSH terms used in CINAHL. The search was restricted to title, abstract (and keyword for the Cochrane Library). Only reviews published in English were included. The results were filtered for reviews, systematic reviews, meta-analyses, and meta-synthesis. The detailed search strategy is presented in Multimedia Appendix 1.
+
+Closer to the end of the report and before publication, an updated search with the same search strategy was conducted to include any new reviews that have been recently published. No new articles of interest were found. PRISMA checklist can be found in Multimedia Appendix 2.
+
+Results
+
+Screening Process and Exclusion and Inclusion Criteria
+
+Figure 1 shows the PRISMA diagram describing the review screening process. The database search returned 579 titles across the 4 databases, including duplicates. The results from each database were exported to EndNote to remove duplicates, and a manual search was conducted to ensure all duplicates were removed before proceeding to the screening process. Removal of duplicates resulted in a total of 386 reviews to be included in the screening, with 18 articles being included in this review. The PRISMA Checklist can also be found as Multimedia Appendix 2.
+
+Screening of the title, abstract, and full text was conducted by authors 1 (RLKC) and 2 (ASEC), and any disagreement was resolved through discussion or through a third party, the last author (YFL). All identified reviews were screened for their relevance to the research question using the set of exclusion and inclusion criteria generated during each stage of the screening process (Table 1).
+
+Figure 1 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Overall, 18 articles were included in this review.
+
+Table 1 Eligibility criteria for selecting articles on telehealth and pharmacy practice. Inclusion criteria: reviews written in English focusing on telehealth and pharmacy practice published within the last 12 years of relevancy. Exclusion criteria: non-review articles, published in languages other than English, focused on specific population or animal studies that were published more than 12 years ago.
+
+Criteria	Inclusion criteria	Exclusion criteria	
+Article type	Reviews	Clinical trials, primary studies, editorials, letters to editor
+
+	
+Language	English	Other languages
+
+	
+Context	Telehealth and pharmacy practice	Unrelated to telehealth or pharmacy practice
+
+Focused on specific populations or animal studies
+
+	
+Time frame	Studies published within the last 12 years	Studies published more than 12 years ago
+
+	
+
+Data Extraction and Analysis
+
+Data from the included reviews were extracted for further processing and analysis in the final report. Data regarding study characteristics such as the year of publication, authors, objectives, interventions, discussions, and conclusions were extracted and summarized into Multimedia Appendix 3. Data analysis was conducted using the GRADE-CERQual.
+
+Principal Findings
+
+Table 2 illustrates the proportion of telehealth interventions in the reviews. Notably, all combinations of interventions included teleconsultation, highlighting its prominence and extensive research. This table is also illustrated as a pie graph included as Multimedia Appendix 4
+
+Telephone-based care was most common in teleconsultations and telemonitoring, while mobile, web, and computer applications were prevalent in telesupport. Telecollaboration typically used a mix of methods, such as telephone, fax, electronic messaging, shared EHR, and video conferencing (Figure 2).
+
+Common features highlighted in the reviews are presented in Table 3. There was a general improvement in health outcomes, hospital readmission rates, patient safety, adherence, satisfaction with service provided, access to care, quality, and overcoming pharmacist shortage.
+
+Table 2 Proportion of telehealth interventions in the 18 reviews on telehealth in pharmacy practice published between August 2012 and December 2024.
+
+Intervention types	Reviews, %	
+Unrelated/pharmacist involvement unspecified	2	
+Combination	
+
+	Telepharmacy (unspecified combination)	13	
+
+	Teleconsultation and monitoring	2.4	
+
+	Teleconsultation and support	2	
+
+	Teleconsultation and collaboration	0.2	
+
+	Teleconsultation, monitoring, and support	0.2	
+
+	Teleconsultation, monitoring, support, and collaboration	0.2	
+Telesupport	16.9	
+Telecollaboration	10.8	
+Teleconsultation	39	
+Telemonitoring	13.2	
+
+Figure 2 Telehealth intervention delivery methods in 18 reviews on telehealth in pharmacy practice. This bar graph illustrates the distribution of different delivery methods used in telehealth interventions across 18 review articles published between August 2012 and December 2024. Telephone-based care was the most widely used method, followed by mobile and web applications. The chart provides a breakdown of the various delivery methods used in teleconsultations, telemonitoring, telesupport, and telecollaboration. Common features associated with these interventions, such as improved health outcomes, reduced hospital readmissions, enhanced patient safety, better medication adherence, increased patient satisfaction, and greater access to care, are further summarized in Table 2. Additionally, the graph highlights the role of telehealth in addressing the pharmacist shortage by extending the reach of pharmacy services.
+
+Table 3 Summary of intervention outcomes from telehealth services in pharmacy practice. This table summarizes the effects of telehealth interventions on health outcomes, including hospital readmissions, patient safety, medication adherence, satisfaction, access to care, quality of care, and pharmacist shortages. Telehealth generally improved surrogate markers and clinical outcomes, though results were mixed across studies. While patient satisfaction and medication adherence showed varied results, telehealth enhanced access to care and operational efficiency. Cost savings were noted in some areas, and telehealth helped alleviate pharmacist shortages, particularly in rural settings. +: improved; –: worsened; +/–: mixed results.
+
+	Health outcomes	Hospital readmission	Patient safety	Adherence	Satisfaction	Time	Access	Pharmacist shortage	Quality	Cost	
+
+	Surrogate markers	Clinical outcomes	
+	Med errors	ADRa	Drug safety	
+	
+	
+	
+	
+	
+	
+	
+Lowry et al [9]	+	No difference	
+	
+	
+	
+	
+	
+	
+	
+	
+	
+	
+	
+Pathak et al [10]	
+	
+	
+	+/–	
+	
+	No difference	–	
+	
+	
+	
+	
+	
+Sarkar et al [11]	
+	
+	
+	+	
+	
+	
+	+	
+	+	+	+	
+	
+Baldoni et al [12]	
+	
+	
+	
+	
+	
+	
+	+	
+	+	+	
+	+	
+Crilly and Kayyali [13]	+	+	
+	
+	
+	
+	
+	No difference	
+	+	
+	
+	
+	
+Diedrich and Dockweiler [14]	No difference	No difference	
+	
+	
+	
+	+	
+	
+	+	
+	
+	
+	
+Emadi et al [15]	
+	
+	
+	
+	
+	
+	+/–	
+	
+	
+	
+	
+	
+	
+Kane-Gill et al [16]	+	+	
+	
+	
+	
+	
+	
+	
+	+	
+	+	+/–	
+Lobo Borba and Woranovicz Carvalho [17]	
+	
+	
+	
+	
+	
+	
+	
+	
+	+	
+	
+	
+	
+Niznik et al [18]	+	+	+	
+	
+	
+	+	
+	
+	
+	
+	
+	
+	
+Park et al [19]	+/–	+/–	No difference	+	+	
+	+	
+	
+	
+	
+	
+	
+	
+Strnad et al [20]	
+	+	
+	+	
+	
+	
+	+	+	
+	
+	
+	+	
+Unni et al [21]	
+	
+	
+	
+	
+	
+	
+	
+	
+	+	
+	–	–	
+Andrzejewski et al [22]	
+	+/–	
+	
+	
+	
+	
+	
+	–	
+	
+	
+	+/–	
+Baines et al [23]	
+	
+	
+	
+	
+	
+	+	
+	
+	
+	
+	
+	
+	
+Dat et al [24]	+	+	
+	–	+	+	
+	+	
+	
+	
+	
+	+	
+Lopez et al [25]	
+	+	+	+	
+	
+	
+	
+	
+	
+	
+	
+	
+	
+Melton et al [26]	
+	+	
+	
+	
+	
+	
+	
+	
+	+	
+	
+	+/–	
+aADR: adverse drug reaction.
+
+Health Outcomes and Hospital Readmission
+
+Health outcomes remain the most widely discussed among the included reviews. Close to half of the reviews (n=8, 50%) either referenced improved surrogate markers or clinical outcomes or a combination of both in their discussions, while 2 revealed mixed results.
+
+Surrogate markers like hemoglobin A1c, blood pressure, International Normalized Ratio (INR), and total cholesterol improved due to telehealth services. Crilly and Kayyali [13] highlighted that community pharmacists' telemonitoring services significantly improved home blood pressure control in the intervention group, which transmitted readings remotely at 6, 12, and 18 months, compared to the control group.
+
+Clinically significant outcomes, such as disease control targets from telehealth interventions, were widely discussed. Strnad et al [20] reported improvements in antimicrobial stewardship through email, with daily recommendations from ID physicians and pharmacists reducing hospital-acquired Clostridium difficile infections and avoidable antimicrobial use. Additionally, there were improvements in bleeding risk for patients on anticoagulation. One review on telemedicine by clinical pharmacists in Colorado found reductions in major bleeding episodes and thromboembolic fatalities compared to standard care [16].
+
+In total, 3 of the reviews reported an impact on hospital readmission rates with the use of telehealth interventions by pharmacists. According to two other reviews, telehealth enabled pharmacists to extend their reach to rural patients or those unable to be physically present, promoting better transitions of care post discharge [18,25]. Park et al [19] mentioned no difference in hospital readmission rate; however, this only pertained to patients with cancer.
+
+Patient Safety, Satisfaction, and Medication Adherence
+
+In total, 6 reviews addressed telehealth services and their impact on medication errors, adverse drug reactions, and drug safety, all related to patient safety. In total, 4 of these reviews reported a reduction in medication errors with telehealth integration. Sarkar et al [11] found significant decreases in medication errors in emergency departments and patient medication regimes when barcode technology was used. Another review noted that telephone medication history interviews helped identify discrepancies in patients’ medical records, including missing information and medication errors. However, most reviews did not discuss the implications of telehealth on drug safety. Dat et al [24] highlighted that telepharmacy services promote drug safety and efficacy by preventing adverse side effects.
+
+There was generally an increase in patient and nurse satisfaction with the use of telehealth in pharmacy practice. In total, 2 exceptions reported no difference in satisfaction, which stated that patient satisfaction with telepharmacies was lower or no different compared to traditional pharmacies, partly due to the longer time required to obtain counselling and medications through telepharmacies [10,13].
+
+In total, 6 of the 18 reviews included in the final review examined medication adherence. The majority of these 6 reviews (n=4, 66.6%) observed improved medication adherence for patients who used telehealth services for their care. One review mentioned that the average usage technique of metered dose inhalers in patients with asthma increased significantly because of multiple 15-minute video consultations [14]. Similarly, telehealth services mentioned in Emadi et al [15], such as text, video, and telephone, greatly improved medication adherence in certain populations, specifically the older generation who receive care from remote rural clinics. However, Emadi et al [15] did note that these improvements were not consistent across all patient populations. Participants that maintained a high level of adherence before the initiation of telehealth interventions remained at the same level following its use. Moreover, patients with HIV and chronic pain also did not experience significant changes in medication adherence following the initiation of these interventions [15].
+
+Quality, Access to Care, and Operational Efficiency
+
+One review indicated that telehealth improved the quality of care through increased medication action, therapy review, and monitoring performed by pharmacists [11]. Similarly, Kane-Gill et al [16] suggested that variability in treatments could be decreased due to increased frequency of follow-ups. However, Unni et al [21] reported a decrease in quality compared to traditional pharmacy practice, as certain assessment tools could not be modified to suit the telepharmacy setting. Additionally, Unni et al [21] reported that diminished patient engagement and increased dispensing errors were observed as reasons for the perceived reduction in the quality of care.
+
+In total, 8 reviews highlighted that telehealth services either provided greater access to 24-hour pharmaceutical services, particularly in hospitals that do not have the capacity for such services or eliminated barriers such as travel distance. Health care professionals were able to consult pharmacists even during night shifts, which led to a greater number of therapeutic interventions [20]. A rise was also seen in the number of patient consultations and health screenings conducted through telehealth modalities [11,17].
+
+There were mixed results regarding the effect of telehealth on operational efficiency. Strnad et al [20] reported a reduction in mean order processing time [20]. Conversely, Andrzejewski et al [22] found that asynchronous workflow and indirect communication led to longer intervention times, indicating that telehealth could sometimes delay service provision.
+
+Cost and Pharmacist Shortage
+
+The impact of telehealth on the costs varied among reviews. Andrzejewski et al [22] and Kane-Gill et al [16] reported that cost savings resulted from preventing unnecessary antimicrobial use or medication errors and adverse drug reactions, while Melton et al [26] stated that costs related to lost wages and productivity due to traveling were prevented. Baldoni et al [12] also mentioned that a single remote pharmacist could cover several sites in place of multiple physical pharmacies, which contributed to lower costs of both manpower and infrastructure. However, greater costs may be incurred to acquire the infrastructure and technology required to perform telehealth or due to a lack of reimbursement policies in place [16,21,26].
+
+Baldoni et al [12] and Sarkar et al [11] mentioned that telehealth helped to relieve the issue of pharmacist shortage, especially in rural hospitals, by allowing workload to be divided between onsite and offsite pharmacists, enhancing productivity and overall care for patients.
+
+Quality Assessment
+
+A 5-point Likert scale risk assessment table was created to evaluate the quality of the included reviews, with 1 indicating “very unsatisfactory” and 5 indicating “very satisfactory.” The domains evaluated were (1) search strategy, (2) screening and selection of articles, (3) data extraction, and (4) data interpretation (Multimedia Appendix 5). Points were deducted based on reasons that the authors felt would reduce the quality of the review, such as the absence of a clear search strategy or screening process or the omission of information such as the type of data extracted. A more detailed breakdown can be found in Multimedia Appendix 6. Corresponding study number can be found in Multimedia Appendix 7.
+
+For a review to have attained a maximum point score of 20, they would have had to meet the “very satisfactory” criteria for all 4 domains of its methodology. For reviews that possessed methodological limitations that were of no concern, they attained scores between 17 and 20. Those with methodological limitations that were of minor or moderate concern had scores between 13 and 16 and 10 and 12, respectively. From Table 4, of the 18 included reviews, 15 reviews had methodological limitations of no concern, 2 had minor concerns, and 1 had moderate concern.
+
+Table 4 Quality assessment table. This table presents the evaluation scores for each article across 4 key categories: search strategy, screening and selection of articles, data extraction, and data interpretation. Most reviews that possessed methodological limitations that were of no concern attained scores between 17 and 20.
+
+Article	Search strategy	Screening and selection of article	Data extraction	Data interpretation	Total	
+Lowry et al [9]	5	5	5	3	18	
+Pathak et al [10]	5	4	5	4	18	
+Sarkar et al [11]	5	4	4	5	18	
+Baldoni et al [12]	5	5	5	5	20	
+Crilly and Kayyali [13]	5	4	5	4	18	
+Diedrich and Dockweiler [14]	4	4	5	1	14	
+Emadi et al [15]	5	5	5	3	18	
+Kane-Gill et al [16]	5	5	4	3	17	
+Lobo Borba and Woranovicz Carvalho [17]	5	4	5	4	18	
+Niznik et al [18]	5	5	5	5	20	
+Park et al [19]	5	5	5	5	20	
+Strnad et al [20]	3	5	5	5	18	
+Unni et al [21]	3	5	4	5	17	
+Andrzejewski et al [22]	1	1	5	5	12	
+Baines et al [23]	5	5	5	5	20	
+Dat et al [24]	5	5	5	5	20	
+Lopez et al [25]	4	4	5	3	16	
+Melton et al [26]	5	5	5	5	20	
+
+Additionally, a GRADE-CERQual scale was used to evaluate the amount of confidence to place in the review findings of the included reviews. Common findings in reviews were grouped together and evaluated according to adequacy, coherence, and relevance and were categorized as either no concerns, minor concerns, or moderate concerns. The majority of the findings had either no or minor concerns. A more detailed breakdown can be found in Multimedia Appendices 6 and 7.
+
+Discussion
+
+Overview
+
+Overall, the results segment has shown that telehealth enhanced care quality and access but had mixed effects on operational efficiency, with potential for cost savings and alleviating pharmacist shortages despite initial infrastructure costs. Telehealth has been increasingly acknowledged as a stable alternative to usual care provided by onsite pharmacists, especially since the advent of the COVID-19 pandemic. Many factors account for this trend, including the ability of telehealth to provide pharmaceutical care across big distances, thereby increasing access to health care [27]. Additionally, manpower shortages can be bridged by connecting remote rural hospitals to larger main pharmacies [28]. Besides this, there has been a shift in focus to a more multidisciplinary approach to patient care in recent years, increasing cooperation between health care professionals, which is facilitated by telehealth [29]. Hence, pharmacy practice has been seeing a rise in the use of telehealth modalities, which is likely to continue in the future.
+
+However, there are certain challenges that limit the growth of telehealth utilization in pharmacy practice. This includes regulations, infrastructure, and technological costs or lack of evidence to support use. Moreover, many studies have highlighted the need to provide pharmacists with adequate training and education to operate telehealth-associated technology and adapt counseling methods or tools to suit telepharmacy before such interventions may be properly implemented into practice [15,16,21,24].
+
+Changing Roles of Pharmacists
+
+Globally, pharmacists have seen a shift away from the traditional roles of dispensing medications toward more patient counseling and monitoring [1]. There has been increasing recognition of pharmacists as an underused group of health care providers who have the necessary skills and knowledge to manage patients in the community setting. This was partly due to the COVID-19 pandemic, whereby many hospitals were overloaded with the surge in cases, resulting in a greater dependence on pharmacists to handle less urgent medical needs. Additionally, there has been a rising prevalence of chronic conditions, such as diabetes or hypertension, that require routine follow-ups and may be adequately managed in the community. Hence, pharmacists are in an ideal position to help patients with chronic conditions or minor ailments while relieving the burden on other health care professions.
+
+Meanwhile, with the rising focus on the significance of multidisciplinary health care and the ease of communication through technology, more telecollaboration was expected. However, telecollaboration consisted of only 11.2% of the interventions in our identified reviews, including telecollaboration alone and in combination with other telehealth interventions. This may be due to traditional physical interactions between health care providers still taking precedence over communicating via virtual means whenever feasible, especially if the health care providers are within proximity of each other.
+
+Significance of Certain Modes of Telehealth Delivery
+
+Telephones are one of the most accessible and inexpensive forms of communication, which supports their extensive use in teleconsultations and telemonitoring. This typically involves verbal discussions between pharmacists and their patients; thus, telephones tend to be a sufficient means of communication.
+
+Internationally, there has been a significant focus on protecting the privacy and security of individuals' health information [20]. For instance, in the United States, there has also been a rise in Health Insurance Portability and Accountability Act–compliant video conferencing platforms, including Zoom and Skype [21]. This was mostly a result of the COVID-19 pandemic when inexpensive platforms were needed urgently to facilitate the delivery of health care services despite social distancing measures in place. Therefore, increased accessibility to such video conferencing platforms likely enabled greater uptake by pharmacists to communicate with both patients and other health care professionals as seen in our results.
+
+The reviews revealed an unexpected finding: the frequent use of mobile, web, and computer applications in telesupport. Despite older patients often struggling with new technology, both patients and health care providers showed receptiveness to these applications. The COVID-19 pandemic accelerated their adoption in health care institutions to reduce disease transmission while maintaining access to services. Thus, this could have influenced patients to be more receptive to such health applications to reduce the risk of COVID-19 infection. Besides this, health applications provide patients with greater access to their health records, which potentially empowers them to gain a better understanding of their condition and engage them in more informed discussions with their health care providers [30]. This feeling of empowerment could have contributed to greater uptake of health applications by patients as well [31,32].
+
+Conversely, remote monitoring devices were expected to be the most used in telemonitoring due to their close association, which was not the case in our findings. A possible explanation would be the additional costs posed by remote monitoring devices. Electronic dosage forms that track adherence, such as blisters, eye drops, or sprays, may be more expensive than regular dosage forms, thus deterring uptake [15]. Moreover, remote monitoring devices may be unavailable in many areas, leading to telemonitoring being conducted through more accessible means like telephones.
+
+Implications and Recommendations
+
+From our results, we observe a growing international effort to incorporate telehealth into future pharmacy practice. For example, the United States became the forerunner for adopting telehealth modalities into its practice. This shift has resulted in increased access to care, improved quality of care, enhanced medication adherence, and greater patient safety, all of which have proven the effectiveness of telehealth in pharmacy practice. These successes have provided strong motivation for other countries to follow suit and explore the potential of telehealth to improve health care delivery.
+
+On a global scale, many countries have leveraged telehealth solutions to overcome challenges such as access to care in remote areas, health care workforce shortages, and the pressures of aging populations [11]. In regions like Europe, Australia, and Canada, telehealth adoption has rapidly expanded in both urban and rural settings, improving continuity of care, especially during public health crises such as the COVID-19 pandemic [21,24].
+
+Locally, in Singapore, telephone consultations have been regularly used by hospitals. For example, in local hospitals, telephone consultations acted as alternatives for follow-ups, especially for outpatient care clinics. The COVID-19 pandemic, coupled with Singapore’s aging population, drove the inception. However, such methods are rarely seen in the community setting. As community general practitioner clinics act as points of confluence for neighborhood residents, incentive for teleconsultation has lacked considerably. In 2012, Guardian introduced MyDoc, an application for patients to interact with a panel of health care professionals, which includes both pharmacists and physicians [4]. With private community pharmacies taking the first steps toward telehealth integration into practice, efforts to replicate their success to allow for greater patient usage are no longer a hopeful belief [31]. Therefore, there lies a great opportunity for telehealth adoption in community health care in Singapore and regions and cities with similar geographical contexts.
+
+With the older adult population having more digital literacy, there is increasing receptiveness to telehealth modalities such as telesupport and telemonitoring [15]. Chatbots can provide telehealth services is one of the opportunities to be explored. Chatbots can be used to provide educational services to aid patients in understanding their disease conditions [33]. Additionally, recording blood pressure and glucose levels among other monitoring parameters can enable greater monitoring by physicians and pharmacists to improve patient disease control [34]. Thus, telesupport and telemonitoring can serve as gateways for adopting changes in traditional pharmacy practice.
+
+As telehealth services are increasingly introduced, pharmacy education must keep pace with the changing landscape and incorporate telehealth as a component of teaching and assessment, such as by conducting virtual formative assessments. This is supported by the identified reviews, which suggest that adequate training is required for pharmacists to deliver telehealth services due to its differences compared to traditional face-to-face interaction with patients [15,16,21,24]. Future pharmacists should be prepared to perform telehealth services competently, and a way to assure that would be through implementing skills and knowledge required for telehealth into undergraduate education. While some courses may touch on telehealth, this approach guarantees that future pharmacists are fully equipped for this evolving field. This can be applied to cities or regions with similar geographical context.
+
+Limitations
+
+A limitation of this review is the subjectiveness of the quality assessment conducted on the 18 identified reviews. Although GRADE-CERQual is a widely used systematic and transparent approach to assess the quality of results in the identified reviews, it is still highly dependent on the authors’ opinions and judgment.
+
+Moreover, a few identified reviews did not elaborate on the specific modes of delivery of telehealth interventions, making it challenging to classify them. This included one review that labeled the delivery modes as “telepharmacy services,” which we classified as a combination of delivery methods based on the context of the review. Additionally, 5 of the reviews had unspecified delivery modes that we were unable to classify into specific telehealth interventions. Therefore, since certain delivery modes were not explicitly stated, the current classification may not be entirely accurate. Furthermore, this review of reviews did not include gray literature, which may have resulted in the exclusion of potentially significant studies. Future reviews could benefit from incorporating gray literature to enhance the comprehensiveness of the findings.
+
+Lastly, the research questions and search strategies in the identified reviews lack homogeneity. Although we screened these reviews, some may not fully relate to our research question, resulting in only a portion of the extracted information being relevant for our systematic review. This led to the exclusion of much irrelevant data. For example, Baldoni et al [12] met our inclusion criteria, but some data on antineoplastic medication preparation and the control of medicine chests on seagoing vessels were irrelevant to our research question.
+
+Conclusions
+
+In conclusion, telehealth interventions have been increasingly established worldwide, demonstrating the potential to deliver both health and non–health-related outcomes in pharmacy practice. While many countries have made strides, particularly in hospital settings, there remains an opportunity for greater adoption in community health care, driven by innovations like telemonitoring and digital literacy among older adults. Community pharmacists can also be positioned as first responders to many health concerns. Additionally, integrating telepharmacy content into pharmacy curricula will better prepare future pharmacists for this evolving practice. The findings from this study can inform the future implementation of telehealth interventions in pharmacy.
+
+This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
+
+Multimedia Appendix 1 Detailed Search Strategy.
+
+Multimedia Appendix 2 PRISMA Checklist.
+
+Multimedia Appendix 3 Data Extraction.
+
+Multimedia Appendix 4 Proportion of telehealth interventions in the 18 reviews on telehealth in pharmacy practice. This pie chart illustrates the distribution of different types of telehealth used in 18 reviews, published between August 2012 and December 2024. Telephone-based care was the most common intervention, primarily used in teleconsultations and telemonitoring. Mobile, web, and computer applications were most prevalent in telesupport services. Telecollaboration, which typically involved a combination of telephone, fax, electronic messaging, shared electronic health records, and video conferencing, was used in several studies to enhance communication between health care providers. These interventions were applied in a variety of pharmacy practice settings, including community pharmacies and telepharmacy services.
+
+Multimedia Appendix 5 GRADE-CERQual Table.
+
+Multimedia Appendix 6 Reasons for Deduction of Scores (Risk Assessment).
+
+Multimedia Appendix 7 Corresponding Study Numbers for GRADE-CERQual Assessment.
+
+Abbreviations
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+MeSH Medical Subject Headings
+
+Data Availability
+
+The datasets generated or analyzed during this study are available from the corresponding author on reasonable request.
+
+Authors' Contributions: RLKC and ASEC researched literature and conceived the study, under the guidance of YFL, our advisor. RLKC and ASEC wrote the first draft of the manuscript. CCMS and LYF made modifications to the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
+
+Conflicts of Interest: None declared.
+
+
+1 Chan J The future of pharmacy is now: a Canadian perspective Aust Pharm Stud J 2024 3 1 50 52 10.55136/apsj3111
+2 Visacri MB Figueiredo IV Lima TDM Role of pharmacist during the COVID-19 pandemic: a scoping review Res Social Adm Pharm 2021 17 1 1799 1806 10.1016/j.sapharm.2020.07.003 33317760 S1551-7411(20)30810-X 33317760 PMC7334137
+3 Kok TWK Chong SJ Yau WKJ Raj Kumar P Chua SBR Nationwide implementation of a centralised telemedicine platform in Singapore to fight the COVID-19 pandemic J Telemed Telecare 2024 30 7 1123 1131 10.1177/1357633X221122890 36046925 36046925 PMC9434191
+4 Yap J From telemedicine to cloud kitchen: Covid-19 reveals 4 key business opportunities in Singapore Vulcan Post 2021 2025-03-04 https://vulcanpost.com/695442/covid-19-business-opportunities-singapore/
+5 Gaziel-Yablowitz M Bates DW Levine DM Telehealth in US hospitals: state-level reimbursement policies no longer influence adoption rates Int J Med Inform 2021 153 104540 10.1016/j.ijmedinf.2021.104540 34332467 S1386-5056(21)00166-0 34332467 PMC9760418
+6 Arora S Huda RK Verma S Khetan M Sangwan RK Challenges, barriers, and facilitators in telemedicine implementation in india: a scoping review Cureus 2024 16 8 e67388 10.7759/cureus.67388 39310647 39310647 PMC11414145
+7 National telemedicine guidelines for Singapore Ministry of Health 2015 2015-01-30 https://www.moh.gov.sg/docs/librariesprovider5/licensing-terms-and-conditions/national-telemedicine-guidelines-for-singapore-(dated-30-jan-2015).pdf
+8 PRISMA 2020 expanded checklist PRISMA 2021 2025-03-04 http://prisma-statement.org/documents/PRISMA_2020_expanded_checklist.pdf
+9 Lowry SJ Kay CN Marsom EN Park JS Poole S Page AT Optimising health outcomes via pharmacist delivered telehealth medicines management: a systematic review Pharm Pract Res 2020 50 5 377 390 10.1002/jppr.1695
+10 Pathak S Blanchard CM Moreton E Urick BY A systematic review of the effect of telepharmacy services in the community pharmacy setting on care quality and patient safety J Health Care Poor Underserved 2021 32 2 737 750 10.1353/hpu.2021.0102 34120974
+11 Sarkar R Metzger BJ Sayre HM Slater CM Katamneni S Coustasse A Telepharmacy and access to pharmaceutical services in rural areas Marshall Digit Scholar 2018 2025-03-04 https://mds.marshall.edu/cgi/viewcontent.cgi?article=1218&context=mgmt_faculty
+12 Baldoni S Amenta F Ricci G Telepharmacy services: present status and future perspectives: a review Medicina (Kaunas) 2019 55 7 327 10.3390/medicina55070327 31266263 medicina55070327 31266263 PMC6681067
+13 Crilly P Kayyali R A systematic review of randomized controlled trials of telehealth and digital technology use by community pharmacists to improve public health Pharmacy (Basel) 2020 8 3 137 10.3390/pharmacy8030137 32759850 pharmacy8030137 32759850 PMC7559081
+14 Diedrich L Dockweiler C Video-based teleconsultations in pharmaceutical care – a systematic review Res Social Adm Pharm 2020 17 9 1523 1531 10.1016/j.sapharm.2020.12.002 33341405
+15 Emadi F Ghanbarzadegan A Ghahramani S Bastani P Baysari MT Factors affecting medication adherence among older adults using tele-pharmacy services: a scoping review Arch Public Health 2022 80 1 199 10.1186/s13690-022-00960-w 36042508 10.1186/s13690-022-00960-w 36042508 PMC9429665
+16 Kane-Gill SL Niznik JD Kellum JA Culley CM Boyce RD Marcum ZA He H Perera S Handler SM Use of telemedicine to enhance pharmacist services in the nursing facility Consult Pharm 2017 32 2 93 98 10.4140/TCP.n.2017.93 28569660 28569660 PMC5454780
+17 Lobo Borba HH Woranovicz Carvalho DM Impact of the fourth industrial revolution on clinical pharmaceutical services: a scoping review Res Social Adm Pharm 2023 19 2 235 242 10.1016/j.sapharm.2022.09.008 36175273 S1551-7411(22)00307-2 36175273
+18 Niznik JD He H Kane-Gill SL Impact of clinical pharmacist services delivered via telemedicine in the outpatient or ambulatory care setting: a systematic review Res Social Adm Pharm 2018 14 8 707 717 10.1016/j.sapharm.2017.10.011 29100941 S1551-7411(17)30236-X 29100941
+19 Park T Muzumdar J Kim H Digital health interventions by clinical pharmacists: a systematic review Int J Environ Res Public Health 2022 19 1 532 10.3390/ijerph19010532 35010791 ijerph19010532 35010791 PMC8744767
+20 Strnad K Shoulders BR Smithburger PL Kane-Gill SL A systematic review of ICU and non-ICU clinical pharmacy services using telepharmacy Ann Pharmacother 2018 52 12 1250 1258 10.1177/1060028018787213 29984590 29984590
+21 Unni EJ Patel K Beazer IR Hung M Telepharmacy during COVID-19: a scoping review Pharmacy (Basel) 2021 9 4 183 10.3390/pharmacy9040183 34842823 pharmacy9040183 34842823 PMC8628897
+22 Andrzejewski C McCreary EK Khadem T Abdel‐Massih RC Bariola JR Tele-antimicrobial stewardship programs: a review of the literature and the role of the pharmacist J Am Coll Clin Pharm 2021 4 8 1016 1033 10.1002/jac5.1489
+23 Baines D Gahir IK Hussain A Khan AJ Schneider P Hasan SS Babar ZUD A scoping review of the quality and the design of evaluations of mobile health, telehealth, smart pump and monitoring technologies performed in a pharmacy-related setting Front Pharmacol 2018 9 678 10.3389/fphar.2018.00678 30093859 30093859 PMC6070776
+24 Dat TV Tu VL Quan NK Minh NH Trung TD Le TN Phuc-Vinh D Trinh DTT Pham Dinh L Nguyen-Thi HY Huy NT Telepharmacy: a systematic review of field application, benefits, limitations, and applicability during the COVID-19 pandemic Telemed J E Health 2023 29 2 209 221 10.1089/tmj.2021.0575 35758766 35758766
+25 Lopez NA Kerelos T Hale G The impact of pharmacists on telehealth during transitions of care: a literature review J Pharm Pract 2023 36 5 1225 1231 10.1177/08971900221104707 35603545 35603545
+26 Melton T Jasmin H Johnson HF Coley A Duffey S Renfro CP Describing the delivery of clinical pharmacy services via telehealth: a systematic review J Am Coll Clin Pharm 2021 4 8 994 1010 10.1002/jac5.1486
+27 Sherman J Telepharmacy? A promising alternative for rural communities Pharmacy Times 2007 2025-03-04 https://www.pharmacytimes.com/view/2007-02-6296
+28 Stratton TP Worley MM Schmidt M Dudzik M Implementing after hours pharmacy coverage for critical access hospitals in northeast Minnesota Am J Health Syst Pharm 2008 2025-03-04 https://academic.oup.com/ajhp/article-abstract/65/18/1727/5128026 10.2146/ajhp070610 18768999
+29 Aghdam MRF Vodovnik A Hameed RA Role of telemedicine in multidisciplinary team meetings J Pathol Inform 2019 10 35 10.4103/jpi.jpi_20_19 31799021 S2153-3539(22)00398-4 31799021 PMC6883478
+30 Qudah B Luetsch K The influence of mobile health applications on patient - healthcare provider relationships: a systematic, narrative review Patient Educ Couns 2019 102 6 1080 1089 10.1016/j.pec.2019.01.021 30745178 S0738-3991(18)30872-3 30745178
+31 François J Audrain-Pontevia AF Boudhraâ S Vial S Assessing the influence of patient empowerment gained through mental health apps on patient trust in the health care provider and patient compliance with the recommended treatment: cross-sectional study J Med Internet Res 2024 26 e48182 10.2196/48182 38345851 v26i1e48182 38345851 PMC10897799
+32 Green G Barragan NC Abraham J Chen S Kuo T Delivery of comprehensive medication management and other clinical services via telehealth by pharmacy type J Pharm Pract 2024 37 3 625 631 10.1177/08971900231158934 36803060 36803060
+33 Laymouna M Ma Y Lessard D Schuster T Engler K Lebouché B Roles, users, benefits, and limitations of chatbots in health care: rapid review J Med Internet Res 2024 26 e56930 10.2196/56930 39042446 v26i1e56930 39042446 PMC11303905
+34 Blood AJ Chang LS Colling C Stern G Gabovitch D Feldman G V BM Methods, rationale, and design for a remote pharmacist and navigator-driven disease management program to improve guideline-directed medical therapy in patients with type 2 diabetes at elevated cardiovascular and/or kidney risk Primary Care Diabetes 2024 18 2 202 209 10.1016/j.pcd.2024.01.005 38302335
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Medicina (Kaunas)
+Journal ID: Medicina (Kaunas)
+NLM Journal ID: 9425208
+Journal ID: medicina
+
+Medicina
+
+ISSN: 1010-660X
+EISSN: 1648-9144
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12943399
+PMID: 41752680
+DOI: 10.3390/medicina62020281
+Article ID: medicina-62-00281
+Article version: 1
+Subjects: Systematic Review
+
+Efficacy and Safety of Serratus Anterior Plane Block for Pain Management in Patients with Rib Fractures: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
+
+https://orcid.org/0009-0003-2337-6588 Alharran Abdullah M. 1 *
+Almutawtah Sara 2
+https://orcid.org/0009-0004-1743-4611 Alblooshi Sarah Saqer 3
+Alsaid Fahad A. 1
+Alajmi Mohammad Salem 4
+AlRumaihi Muneera Jasim 1
+Albuhmaid Sara Ahmed 1
+Camporesi Enrico Mario Academic Editor
+Bittner Edward A. Academic Editor
+1 College of Medicine and Medical Sciences, Arabian Gulf University, Manama P.O. Box 26671, Bahrain; fahad.abdulnasser1@gmail.com (F.A.A.); muneerajjr@gmail.com (M.J.A.); saraamb@agu.edu.bh (S.A.A.)
+2 Kuwait Institute for Medical Specialization, Kuwait City P.O. Box 1793, Kuwait; saraalmutawtah1@gmail.com
+3 Department of Surgery, Al Jahra Hospital, Kuwait City 13001, Kuwait; alblooshisarah66@gmail.com
+4 Faculty of Medicine and Health Sciences, Jordan University of Science and Technology, Amman 22110, Jordan; mohammadaldlaim@gmail.com
+* Correspondence: dr_alharran@outlook.com
+Electronic publication date: 2026 Jan 29
+Publication date: 2026 Feb
+Volume: 62
+Issue: 2
+Electronic Location ID: 281
+Received 2025 Nov 5; Revised 2025 Nov 28; Accepted 2026 Jan 16
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Published by MDPI on behalf of the Lithuanian University of Health Sciences. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: SAPB, pain management, analgesia, anesthesia, chest trauma
+
+Funding: This research received no external funding.
+
+Ÿ==============================Ÿ
+Background and Objectives: Rib fractures cause intense pain, leading to respiratory complications. Standard care relies on systemic opioids, which carry significant adverse effects. The serratus anterior plane block (SAPB) has emerged as a promising regional anesthetic technique, but its efficacy remains unclear. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of SAPB versus standard care in patients with rib fractures. Materials and Methods: A comprehensive search of PubMed, Scopus, CENTRAL, and Web of Science was conducted for RCTs comparing SAPB to standard care in adults with rib fractures. The primary outcome was the pain score. Secondary outcomes included 24 h opioid consumption, need for rescue analgesia, and complications. Standardized mean differences (SMD) and risk ratios (RR) were pooled, using STATA SE 19.5. Results: Three RCTs involving 310 patients were included. SAPB significantly decreased pain scores at 2 h (SMD: −1.30, 95% CI [−2.39, −0.20]; p = 0.02), 6 h (SMD: −0.75, 95% CI [−1.41, −0.09]; p = 0.03), 12 h (SMD: −0.37, 95% CI [−0.68, −0.07]; p = 0.02), and 24 h (SMD: −5.67, 95% CI [−9.90, −1.43]; p = 0.01). This was associated with a significant reduction in 24 h opioid consumption (SMD: −0.45, 95% CI [−0.69, −0.21]; p < 0.001). However, no significant differences were found in the need for rescue analgesia (RR: 1.06, 95% CI [0.97, 1.16]; p = 0.18). Conclusions: SAPB provides significant short-term analgesic benefits and reduces opioid consumption in patients with acute rib fractures. While it appears safe, the current evidence is limited by a small number of trials and is insufficient to recommend SAPB as a first-line management option over standard care.
+
+1. Introduction
+
+Rib fractures are the most common injury following chest trauma [1]. The resulting pain from rib fractures is usually intense and difficult to manage [2]. This intense pain limits the chest wall’s normal movements, with symptoms like guarding, hypoventilation, difficulty coughing, and shallow breathing, which together increase the risk of lung collapse [3,4]. This sequence of poor pain control and respiratory dysfunction is directly linked to a high incidence of major complications [5], including retention of pulmonary secretions, nosocomial pneumonia, respiratory failure, and the need for mechanical ventilation [6]. Therefore, optimal pain management after rib fracture is critical.
+
+The standard care for rib fracture pain remains patient-tailored multimodal pain management [7]. This strategy usually focuses on systemic analgesics, starting with routine paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) [8]. However, the primary treatment for severe pain depends on systemic opioids, administered as intravenous (IV) morphine infusions or via Patient-Controlled Analgesia (PCA) [8,9]. Still, opioids can cause several adverse events, including delirium, constipation, sedation, or ileus [10]. Also, opioids can cause respiratory depression, which can directly exacerbate the underlying pulmonary compromise in this patient population [11].
+
+Thus, investigating other pain management options is necessary, such as local nerve block techniques. Recent trends in thoracic anesthesia have demonstrated a marked shift from neuraxial techniques, such as thoracic epidural analgesia, toward fascial plane blocks [7,12]. This transition is largely driven by the favorable safety profile of fascial blocks, which avoid the risks of hypotension and spinal hematoma associated with neuraxial techniques, making them valuable for trauma patients who may be coagulopathic or require anticoagulation [13].
+
+In this regard, the serratus anterior plane block (SAPB) has emerged as a promising regional anesthesia technique. SAPB is an ultrasound-guided fascial plane block that provides targeted analgesia to the hemithorax [14]. This process requires injecting a local anesthetic into the fascial plane around the serratus anterior muscle, specifically targeting the lateral cutaneous branches of the thoracic intercostal nerves [15]. This technique offers a wide-ranging nerve block, usually affecting the T2 to T9 dermatomes, potentially decreasing the need for systemic opioids and their adverse effects [16]. This offers significant pain control while avoiding the adverse events associated with opioid analgesics.
+
+Recently, some systematic reviews have attempted to synthesize the evidence for regional anesthesia in blunt thoracic trauma [7,17,18]. However, these reviews have either analyzed SAPB collectively with other fascial plane blocks, such as the erector spinae plane block [18], or utilized network meta-analysis that relies on indirect comparisons [7]. Also, earlier reviews were limited by the small sample sizes of available trials and the inclusion of observational data [17]. The recent publication of the large multicenter SABRE trial provides strong, novel, high-quality evidence that warrants a dedicated synthesis [19]. Therefore, we conducted this systematic review and meta-analysis to provide a focused and up-to-date synthesis specifically of RCTs comparing SAPB versus standard care in patients with rib fractures.
+
+2. Methodology
+
+2.1. Protocol Registration
+
+This systematic review was registered in PROSPERO [CRD420251183783]. The methods for this systematic review and meta-analysis complied with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [20] and the Cochrane Handbook for Systematic Reviews of Interventions [21].
+
+2.2. Data Sources and Search Strategy
+
+A systematic literature search was performed on 30 October 2025 by [A.M.A, S.A] across the following electronic databases: PubMed, Scopus, CENTRAL, and Web of Science. The search strategy utilized a combination of keywords and MeSH terms, including (“rib fracture*” OR “flail chest” OR “blunt chest trauma” OR “thoracic trauma” OR “chest wall injury”) AND (“serratus anterior plane block” OR “serratus plane block” OR “serratus block” OR “SAPB”). A complete overview of search terms and database results is presented in Table S1. Also, we manually reviewed the reference sections of all eligible trials to ensure complete coverage and avoid excluding any relevant studies.
+
+2.3. Eligibility Criteria
+
+Randomized Controlled Trials (RCTs) were included if they followed the following Population, Intervention, Control, and Outcome (PICO) criteria:Population (P): Adult patients with acute pain from traumatic rib fractures.
+
+Intervention (I): SAPB, regardless of anesthetic, volume, or technique (e.g., superficial or deep plane).
+
+Control (C): Standard of care, which included multimodal oral/IV analgesia or patient-controlled analgesia (PCA) with opioids.
+
+Outcomes (O): The primary outcome was the pain score at different time points post-intervention. Secondary outcomes included total opioid consumption, need for rescue analgesia, LoS, and complications.
+
+2.4. Study Selection
+
+Utilizing Covidence, the eligibility of the retrieved records was independently assessed by two reviewers (A.M.A, S.S.A). Following the automated removal of duplicates by Covidence, the remaining articles underwent screening in two phases. Initially, titles and abstracts underwent screening, followed by an evaluation of the full text of potentially eligible studies. Discrepancies among reviewers were resolved through discussion.
+
+2.5. Data Extraction
+
+Data extraction was independently performed by two reviewers (F.A.A, M.S.A). Any inconsistencies were resolved through discussion and consultation with the senior author. The data extraction process involved creating an Excel spreadsheet, which underwent pilot testing before formal extraction. The extraction form was organized into three main categories:Study characteristics: Study ID, country, study design, total number of patients, SAPB details, control group details, main inclusion criteria, primary outcome, and follow-up duration.
+
+Participant baseline characteristics: Age, gender, ASA status, BMI, number of rib fractures, and location of rib fractures.
+
+Outcome data: Pain scores at all reported time points, total opioid/analgesic consumption, LoS, need for further analgesia, and complications.
+
+Dichotomous data were extracted as the number of events and total participants, whereas continuous data were extracted as the mean and standard deviation. We utilized the formulas proposed by Wan et al. [22] to convert data reported as median and interquartile range into mean and standard deviation.
+
+2.6. Risk of Bias Assessment and Certainty of Evidence Evaluation
+
+Methodological quality was evaluated for each RCT using the revised Cochrane Collaboration’s Risk of Bias tool (RoB 2) [23]. Two reviewers (M.J.A, S.A.A) independently assessed each study across the five domains (randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result). Disagreements were resolved by discussion among the reviewers to reach a consensus. Additionally, the overall certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach [24,25], which considers risk of bias, inconsistency, indirectness, imprecision, and publication bias. Each factor was carefully considered, and the reasoning behind every decision was clearly explained, resolving differences through open discussion.
+
+2.7. Statistical Analysis
+
+The statistical analyses were performed using Stata/SE version 19.5 (StataCorp., College Station, TX, USA). For continuous outcomes, the standardized mean difference (SMD) was calculated for pain and total opioid consumption, as studies used different assessment tools or units, respectively. To interpret the magnitude of SMD, we applied Cohen’s criteria: an SMD of approximately 0.2 was considered a small effect, 0.5 a moderate effect, and 0.8 or greater a large effect [26]. The Risk Ratio (RR) was calculated for dichotomous outcomes. The default analysis model was a fixed-effect model; however, a random-effects model was used if significant heterogeneity was detected. Heterogeneity was evaluated using the chi-squared (χ2) test and the I2 statistic. A p-value less than 0.1 for the χ2 test or an I2 value of 50% or higher indicated significant heterogeneity. In case of significant heterogeneity, a leave-one-out sensitivity analysis was performed to investigate the stability of the results. Finally, an assessment of publication bias was not possible, as all analyzed outcomes included fewer than 10 RCTs [27].
+
+3. Results
+
+3.1. Search Results and Study Selection
+
+A total of 282 records were identified through database searching. After removing 168 irrelevant records, 114 records remained for screening. During the screening process, 99 records were excluded. Then, 15 full texts were assessed for eligibility. Of these, 12 studies were excluded for different reasons (Table S2). Finally, three trials [5,19,28] met the inclusion criteria and were included in the systematic review (Figure 1).
+
+3.2. Characteristics of Included Studies
+
+This review included three RCTs and 310 patients [5,19,28]. The studies were conducted across three different countries: Egypt, Australia, and Turkey. SAPB intervention consisted of a single-shot, ultrasound-guided block, though a specific anesthetic regimen that differed between the trials. Further details on the study design of the included trials are outlined in Table 1. Also, details on the included patients’ baseline data are outlined in Table 2.
+
+3.3. Risk of Bias and Certainty of Evidence
+
+Tekşen et al. showed an overall low risk of bias [28]. Partyka et al. raised concerns about bias due to the open-label interventions and assessment of subjective outcomes [19]. Abu-Elwafa et al. showed a high risk of bias due to several problems, including selection bias (lack of randomization details), performance bias (open-label interventions), detection bias (open-label assessment of subjective outcomes), and reporting bias (lack of a registered protocol or ethical review board ID, with absent outcomes that were reported as assessed in the methods) [5] (Figure 2). Additionally, the certainty of evidence assessment details is reported in Table 3.
+
+3.4. Primary Outcome: Pain Score
+
+SAPB significantly decreased pain scores at all measured time points, including after 2 h (SMD: −1.30, 95% CI [−2.39, −0.20], p = 0.02, I2 = 90.43%) (Figure 3A), after 4 h (SMD: −1.25, 95% CI [−2.44, −0.06], p = 0.04, I2 = 92.06%) (Figure 3B), after 6 h (SMD: −0.75, 95% CI [−1.41, −0.09], p = 0.03, I2 = 77.18%) (Figure 3C), after 12 h (SMD: −0.37, 95% CI [−0.68, −0.07], p = 0.02, I2 = 18.67%) (Figure 3D), and after 24 h (SMD: −5.67, 95% CI [−9.90, −1.43], p = 0.01, I2 = 98.42%) (Figure 3E).
+
+For the pain score after 24 h, which exhibited extreme heterogeneity (I2 = 98.42%), a leave-one-out sensitivity analysis showed that the result became statistically non-significant after omitting any of the included studies (Figure S1). Also, the Galbraith plot suggested that Tekşen et al. was a potential source of the observed heterogeneity (Figure S2). Despite heterogeneity being noted in several other timepoints, we could not investigate the heterogeneity further, as only two trials reported it.
+
+3.5. Secondary Outcomes
+
+3.5.1. Analgesia Consumption
+
+Regarding 24 h opioid consumption, SAPB was associated with a significant decrease (SMD: −0.45, 95% CI [−0.69, −0.21], p < 0.001, I2 = 0%) (Figure 4A). However, there was no significant difference between the groups regarding the need for rescue analgesia (RR: 1.06, 95% CI [0.97, 1.16], p = 0.18, I2 = 0%) (Figure 4B).
+
+3.5.2. Health Services and Long-Term Outcomes
+
+Regarding the length of stay, Partyka et al. reported no significant difference in either ICU LoS (Median 2.4 days for SAPB vs. 1.8 days for control, p = 0.91 $) or hospital LoS (Median 4.2 days for SAPB vs. 5 days for control, p = 0.3) [19]. Abu-Elwafa et al. listed ICU LoS as an outcome, but no results were reported [5]. Additionally, 30-day mortality was reported by Partyka et al. and was not significantly different between groups (1.2% for SAPB vs. 3.5% for control, p = 0.62) [19]. Finally, Partyka et al. measured 30-day quality of life using the EQ-5D-5L and found no measurable differences between the groups [19].
+
+3.5.3. Complications
+
+The respiratory complications were assessed by Partyka et al., who found no significant difference in the rates of pneumonia (10% in the SAPB group vs. 11% in the control group). In that same trial, two patients in the SAPB group required mechanical ventilation compared to none in the control group, while one patient in each group required non-invasive ventilation [19]. Also, Tekşen et al. measured peripheral oxygen saturation (SpO2) and reported that it was significantly higher in the SAPB group at both 1 h (p = 0.012) and 24 h (p = 0.008) compared to the control group [28].
+
+Moreover, delirium was measured by Partyka et al., who found a higher incidence (though not statistically significant, p = 0.09) in the SAPB group (20%) compared to the control group (9%) [19]. Regarding opioid-related side effects, Tekşen et al. reported nausea and vomiting in three control group patients (due to tramadol) and none in the SAPB group [28]. Similarly, Abu-Elwafa et al. reported two cases of constipation in the control (IV morphine) group and none in the SAPB group [5].
+
+4. Discussion
+
+This review, synthesizing data from three RCTs and 310 patients, found that SAPB provides statistically superior analgesia compared to standard care for rib fracture pain. This benefit was observed at all pooled time points within the first 24 h (2, 4, 6, 12, and 24 h). A significant reduction in 24 h opioid consumption integrated this analgesic advantage. However, these analgesic benefits did not translate into a significant decrease in the need for rescue analgesia, nor did they impact outcomes like ICU or hospital length of stay.
+
+The SAPB’s effectiveness is due to its specific anatomical target. The block specifically targets the lateral cutaneous branches of the thoracic intercostal nerves, which are responsible for sensation in the anterolateral and posterior thorax [16]. The anesthetic blocks these nerves across a wide dermatomal range, from T2 to T9 [14,16]. This extensive block explains its utility for rib fractures, which often span multiple thoracic levels. Along with the intercostal nerves, the block can extend to the intercostobrachial, long thoracic, and thoracodorsal nerves, which further contribute to analgesia of the hemithorax [28].
+
+Two unique techniques are described for performing SAPB: a superficial and a deep injection. The included studies used the superficial SAPB, involving the injection of local anesthetic into the plane superficial to the serratus anterior muscle (between the serratus anterior and latissimus dorsi muscles) [5]. This approach is often considered easier to perform and may achieve a wider spread of anesthetic [14]. Alternatively, a deep SAPB administers the anesthetic deep to the serratus anterior muscle (between the serratus anterior and the external intercostal muscles) [29]. Although deep injection facilitates anesthetic dispersion through respiratory movements [30], the superficial approach blocks the long thoracic nerve more effectively. It is, however, crucial to acknowledge that the SAPB does not impact the posterior rami or the anterior cutaneous branches of the intercostal nerves, thereby not replicating the comprehensive hemithoracic anesthesia achieved by methods such as thoracic epidural anesthesia [30].
+
+It is also notable that the included trials utilized single-shot techniques. However, the use of a continuous SAP catheter may provide superior and more sustained pain control compared to a single injection. This can further avoid the need for rescue analgesics and decrease the length of hospital stay [31,32]. Also, the clinical efficacy of the block likely depends on the complexity of the trauma. To clarify, factors such as the presence of bilateral rib fractures, flail chest, and a higher total number of fractured ribs generally mandate more aggressive multimodal analgesia that a unilateral single-shot block may not fully address [33,34].
+
+The primary finding of better analgesia is most marked in the immediate acute phase. The pooled data indicate the strongest effect size in the first 2–6 h, which is consistent with the expected pharmacokinetics of a single-shot regional block using long-acting local anesthetics [35]. The pooled effect at 24 h; however, showed extreme heterogeneity. Also, this unusually large effect size (SMD: −5.67) appears to be driven by Tekşen et al. [26], where the reported median pain scores exhibited very narrow interquartile ranges. The conversion of this non-parametric data to means and standard deviations resulted in extremely small variance estimates, which mathematically inflated the SMD [22]. Consequently, this specific point estimate should be interpreted with caution, as evidenced by the sensitivity analysis where the removal of Tekşen et al. [26] significantly changed the results.
+
+Beyond statistical conversions, the observed heterogeneity likely reflects the significant clinical and methodological diversity among the included trials. Clinically, the control arm interventions varied: while Partyka et al. [19] employed a pragmatic standard care bundle that allowed for diverse analgesic regimens including oral opioids, Abu-Elwafa et al. [5] utilized a strict IV morphine protocol, and Tekşen et al. [26] used a tramadol PCA regimen. Such variations in the standard of care may have led to different baseline pain levels. Also, methodologically, differences in pain scales (VAS vs. NRS) and the timing of assessments related to the block performance further contribute to the observed heterogeneity. Despite these differences, the direction of the effect remained consistent across studies, favoring SAPB.
+
+Additionally, a significant clinical advantage of regional anesthesia is its opioid-sparing effect. This significant analgesic benefit was reflected in the substantial reduction in opioid consumption up to 24 h. The data strongly suggest that SAPB is an effective method for reducing patients’ reliance on systemic opioids. However, the reduction in pain and opioid use was not consistent with the lack of difference in the need for rescue analgesia. The heterogeneous “rescue analgesia” definition in each trial is the key to understanding this contradiction. Partyka et al. reported that the “rescue analgesia” was not for ineffective analgesia [19]. They noted that approximately 27–28% of both groups were given further regional blocks as a standard escalation in care when the initial block’s effects subsided [19]. In contrast, the control groups in the other trials were already being treated with strong painkillers, such as IV morphine infusion and tramadol PCA [5,28].
+
+Moreover, SAPB appears to be a safe procedure. All trials, encompassing 153 patients receiving the block, reported zero block-related complications such as local anesthetic systemic toxicity, pneumothorax, or hematoma [5,19,28]. Specifically, no patients experienced pneumothorax, vascular injury, hematoma, or local anesthetic systemic toxicity. This is consistent with the established safety record of ultrasound-guided fascial plane blocks [36]. Also, the opioid-sparing impact yielded obvious benefits; the SAPB groups reported fewer opioid-related adverse effects, such as nausea/vomiting and constipation. Still, Partyka et al. observed a non-significant trend toward increased delirium within the SAPB cohort [19]. This requires careful consideration, despite the authors’ recognition that their SAPB group exhibited a higher baseline comorbidity burden [19]. Finally, Tekşen et al. reported that SAPB significantly reduced the incidence of chronic pain at three months [28]. Given the prevalence of chronic pain after thoracic trauma, which can affect up to 50% of patients [37,38], this observation supports the potential for a long-term, preemptive analgesic benefit that warrants further study.
+
+Furthermore, contextualizing SAPB within the broader context of regional anesthesia is essential. While thoracic epidural analgesia and paravertebral block have historically been considered the gold standards, their application is often limited by risks of hypotension and spinal hematoma, particularly in coagulopathic trauma patients [7]. In contrast, SAPB is a superficial block with a superior safety profile. Recently, the erector spinae plane (ESP) block has emerged as another regional option that provides analgesia for posterior and lateral rib fractures [18]. However, a distinct advantage of SAPB is its feasibility in the supine position. Unlike the ESP block, which typically requires patient repositioning, SAPB is technically less challenging to perform in immobilized trauma patients while showing a comparable opioid-sparing efficacy [7,13].
+
+5. Clinical Implications
+
+Accordingly, while SAPB may not yet totally replace the current standard neuraxial techniques, it should be prioritized in specific clinical scenarios. Notably, SAPB can be the preferred regional option for patients with contraindications to neuraxial anesthesia, such as coagulopathy or therapeutic anticoagulation, as it avoids the risk of spinal hematoma associated with epidural or paravertebral blocks [13]. It is also perfectly suited for the acute trauma setting, as it can be performed rapidly in the emergency department on supine patients maintained on spinal precautions [15,19]. Finally, for elderly patients or those with opioid intolerance, SAPB serves as a critical opioid-sparing adjunct to mitigate delirium and respiratory depression [12].
+
+6. Limitations
+
+The primary limitation is the small number of included studies, which restricts the power of all pooled analyses. Second, two of the three trials had multiple concerns of bias. Third, the control groups received different regimens of standard of care, from standard care bundles to IV morphine and tramadol PCA. Fourth, the pain score analyses suffered from high statistical heterogeneity, making the magnitude of the pooled effect uncertain. Fifth, there was some variability in the SAPB technique; while predominantly superficial, the specific local anesthetic regimens and volumes varied across included studies, which may have influenced the duration and efficacy of the block. Sixth, this review could not pool functional respiratory outcomes, as they were not reported in the included trials. Seventh, long-term follow-up data remain limited, with only one trial assessing the incidence of chronic pain at three months [28], restricting our ability to draw conclusions regarding the prevention of chronic post-traumatic pain. Finally, these limitations affected the GRADE certainty of evidence assessment, rendering it either low or very low.
+
+7. Conclusions
+
+SAPB provides significant analgesic benefits and reduces opioid consumption in patients with acute rib fractures. While it showed an excellent safety profile, the current evidence, based on a small number of trials, is insufficient to consider SAPB as a first-line management option for rib fractures. Accordingly, future research should prioritize large-scale, multicenter RCTs to establish definitive practice guidelines. These future trials should aim to standardize the SAPB technique and employ consistent multimodal control regimens to minimize the clinical heterogeneity observed in current evidence.
+
+Supplementary Materials
+
+The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/medicina62020281/s1, Figure S1: Leave-one-out sensitivity analysis of pain score after 24 h; Figure S2: Galbraith plot of pain score after 24 h; Table S1: Search strategy; Table S2: Excluded records in full-text screening; Table S3: PRISMA 2020 Checklist.
+
+Author Contributions
+
+A.M.A. and F.A.A. contributed to study conception, data analysis (meta-analysis), study supervision, and primary manuscript drafting. S.A. and S.S.A. performed the systematic literature search and study screening/selection. F.A.A. and M.S.A. carried out the data extraction and validation. M.J.A. and S.A.A. contributed to the risk of bias and GRADE certainty of evidence assessment. All authors A.M.A., S.A., S.S.A., F.A.A., M.S.A., M.J.A. and S.A.A. contributed to the overall literature review, data interpretation, and critical revision of the manuscript for editorial and intellectual content. All authors have read and agreed to the published version of the manuscript.
+
+Institutional Review Board Statement
+
+Ethical review and approval were waived for this study, as it is a systematic review and meta-analysis based exclusively on previously published data and does not involve any new studies with human participants or animals.
+
+Informed Consent Statement
+
+Not applicable.
+
+Data Availability Statement
+
+No new data were created or analyzed in this study.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Figure 1 PRISMA flow chart of the screening process.
+
+Figure 2 Quality assessment of risk of bias in the included trials. The upper panel presents a schematic representation of risks (low = green, unclear = yellow, and high = red) for specific types of biases of the studies in the review. The lower panel presents risks (low = red, unclear = yellow, and high = red) for the subtypes of biases of the combination of studies included in this review [5,19,28].
+
+Figure 3 Forest plots of the primary outcome (pain score), CI: confidence interval [5,19,28].
+
+Figure 4 Forest plots of the secondary outcomes (analgesia consumption), CI: confidence interval [5,19,28].
+
+medicina-62-00281-t001_Table 1 Table 1 Summary characteristics of the included RCTs.
+
+Study ID	Study Design	Country	Total Participants	SAPB Details	Control Details	Adjuvant Analgesia	Primary Outcome	Pain Assessment Score	Main Inclusion Criteria	Follow-Up Duration	
+Abu-Elwafa et al. 2021 [5]	RCT	Egypt	40	Technique: Ultrasound-guided (Superficial). Regimen: Bupivacaine 0.25% (15 mL) + Lidocaine 1% (15 mL). Total Volume: 30 mL	Drug: IV Morphine. Dosing: 0.1 mg/kg loading dose, 10–20 ug/kg/h infusion. Administration: Intravenous infusion.	Rescue analgesia (paracetamol, ketorolac) was available for both groups.	Pain score	VAS (0–10)	Patients >15 years. Lateral/anterior multiple rib fractures (3–6 ribs). Excruciating pain is not responding to conventional analgesics.	24 h	
+Partyka et al. 2024 (SABRE) [19]	RCT	Australia	210	Technique: Ultrasound-guided (Superficial or Deep). Regimen: Ropivacaine 0.375%. Total Volume: 40 mL	Standard Care. Included protocolized rib fracture care bundles with multimodal oral or intravenous analgesia.	Both groups received protocolized rib fracture care bundles, including multimodal analgesia (e.g., paracetamol, NSAIDs).	Composite pain score at 4 h (defined as pain score reduction ≥ 2 points AND absolute pain score < 4).	NRS (0–10)	Patients ≥16 years. Clinically suspected or radiologically proven rib fractures.	30 days	
+Tekşen et al. 2021 [28]	RCT	Turkey	60	Technique: Ultrasound-guided (Superficial). Regimen: Bupivacaine 0.25%. Total Volume: 30 mL	The control group received PCA without a block. Comparator Details: Drug: IV Tramadol. Dosing: 10 mg per press. Administration: PCA	All patients in both groups received IV tramadol PCA.	Total tramadol consumption in 24 h.	NRS (0–10)	Patients aged 18–90 years. Rib fracture pain. Baseline NRS pain score ≥ 4.	24 h	
+RCT: Randomized Controlled Trial. SAPB: Serratus Anterior Plane Block. IV: Intravenous. ug/kg/h: Micrograms per kilogram per hour. mg/kg: Milligrams per kilogram. mL: Milliliter. NSAIDS: Nonsteroidal Anti-inflammatory Drugs. PCA: Patient-Controlled Analgesia. VAS: Visual Analog Scale. NRS: Numerical Rating Scale. N: Number.
+
+medicina-62-00281-t002_Table 2 Table 2 Baseline characteristics of the participants.
+
+Study ID	Number of Participants in Each Group	Age (Years), Mean (SD)	Gender (Male/Female)	ASA I/II/III/IV	Rib Fracture Location	Number of Rib Fractures	
+SAPB	Standard Care	SAPB	Standard Care	SAPB	Standard Care	SAPB	Standard Care	SAPB	Standard Care	SAPB	Standard Care	
+Abu-Elwafa et al. 2021 [5]	20	20	NR	NR	NR	NR	NR	NR	Lateral or anterior (Inclusion criteria)	Lateral or anterior (Inclusion criteria)	3 to 6 ribs (Inclusion criteria)	3 to 6 ribs (Inclusion criteria)	
+Partyka et al. 2024 (SABRE) [19]	103	104	71 (54–85)	71 (58–82)	67/36	62/42	NR	NR	A: 8, L: 58, P: 17	A: 9, L: 57, P: 17	4 (2–5)	3 (2–5)	
+Tekşen et al. 2021 [28]	30	30	50.7 (18.8)	42.4 (15.8)	11/19	7/23	14/13/3	7/22/1	P: 15, L: 5, A: 10	P: 11, L: 10, A: 9	NR	NR	
+N: Number. SAPB: Serratus Anterior Plane Block. SD: Standard Deviation. NR: Not Reported. ASA: American Society of Anesthesiologists. A: Anterior. L: Lateral. P: Posterior.
+
+medicina-62-00281-t003_Table 3 Table 3 GRADE evidence profile.
+
+Certainty Assessment	Summary of Findings	
+Participants
+(Studies)
+Follow-Up	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Overall Certainty of Evidence	Study Event Rates (%)	Relative Effect
+(95% CI)	Anticipated Absolute Effects	
+with [SoC]	with [SAPB]	Risk with [SoC]	Risk Difference with [SAPB]	
+Pain Score at 2 h	
+231
+(2 RCTs)	serious a	very serious b	not serious	very serious c,d	none	⨁◯◯◯
+Very low a,b,c,d	-	-	-	-	SMD 1.3 SD lower
+(2.39 lower to 0.2 lower)	
+Pain Score at 4 h	
+248
+(2 RCTs)	serious a	very serious b	not serious	very serious c,d	none	⨁◯◯◯
+Very low a,b,c,d	-	-	-	-	SMD 1.25 SD lower
+(2.44 lower to 0.06 lower)	
+Pain Score at 6 h	
+198
+(2 RCTs)	serious a	very serious b	not serious	very serious c,d	none	⨁◯◯◯
+Very low a,b,c,d	-	-	-	-	SMD 0.75 SD lower
+(1.41 lower to 0.09 lower)	
+Pain Score at 12 h	
+166
+(2 RCTs)	serious a	not serious	not serious	serious d	none	⨁⨁◯◯
+Low a,d	-	-	-	-	SMD 0.37 SD lower
+(0.68 lower to 0.07 lower)	
+Pain Score at 24 h	
+189
+(3 RCTs)	serious a	very serious b	not serious	very serious c,d	none	⨁◯◯◯
+Very low a,b,c,d	-	-	-	-	SMD 5.67 SD lower
+(9.9 lower to 1.43 lower)	
+Opioid Consumption (24 h)	
+267
+(2 RCTs)	serious a	not serious	not serious	very serious c,d	none	⨁◯◯◯
+Very low a,c,d	-	-	-	-	SMD 0.45 SD lower
+(0.69 lower to 0.21 lower)	
+Need for Rescue Analgesia	
+307
+(3 RCTs)	serious a	not serious	not serious	serious e	none	⨁⨁◯◯
+Low a,e	12/154 (7.8%)	8/153 (5.2%)	RR 1.06
+(0.97 to 1.10)	12/154 (7.8%)	5 more per 1000
+(from 2 fewer to 8 more)	
+CI: confidence interval; RR: risk ratio; SMD: standardized mean difference; Explanations: a. Partyka et al. raised concerns about bias due to the open-label interventions and assessment of subjective outcomes. Abu-Elwafa et al. [5] showed a high risk of bias due to several problems, including selection bias (lack of randomization details), performance bias (open-label interventions), detection bias (open-label assessment of subjective outcomes), and reporting bias (lack of a registered protocol or ethical review board ID, with absent outcomes that were reported as assessed in the methods). b. I2 > 75%. c. A wide confidence interval. d. Low number of participants. e. Low number of events.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: PLoS One
+Journal ID: PLoS One
+NLM Journal ID: 101285081
+Journal ID: plos
+
+PLOS One
+
+EISSN: 1932-6203
+Publisher: PLOS
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13541177
+PMID: 42691038
+DOI: 10.1371/journal.pone.0357408
+Article ID: PONE-D-26-13065
+Article version: 1
+Subjects: Study Protocol, Biology and Life Sciences, Microbiology, Medical Microbiology, Microbial Pathogens, Viral Pathogens, Immunodeficiency Viruses, HIV, Medicine and Health Sciences, Pathology and Laboratory Medicine, Pathogens, Microbial Pathogens, Viral Pathogens, Immunodeficiency Viruses, HIV, Biology and Life Sciences, Organisms, Viruses, Viral Pathogens, Immunodeficiency Viruses, HIV, Biology and Life Sciences, Organisms, Viruses, Immunodeficiency Viruses, HIV, Biology and life sciences, Organisms, Viruses, RNA viruses, Retroviruses, Lentivirus, HIV, Biology and Life Sciences, Microbiology, Medical Microbiology, Microbial Pathogens, Viral Pathogens, Retroviruses, Lentivirus, HIV, Medicine and Health Sciences, Pathology and Laboratory Medicine, Pathogens, Microbial Pathogens, Viral Pathogens, Retroviruses, Lentivirus, HIV, Biology and Life Sciences, Organisms, Viruses, Viral Pathogens, Retroviruses, Lentivirus, HIV, Medicine and health sciences, Diagnostic medicine, HIV diagnosis and management, People and Places, Geographical Locations, Africa, Malawi, Medicine and health sciences, Epidemiology, HIV epidemiology, Medicine and Health Sciences, Pediatrics, Medicine and Health Sciences, Health Care, Health Care Policy, Medicine and Health Sciences, Health Care, Health Care Policy, Health Systems Strengthening, Medicine and Health Sciences, Pediatrics, Child Health, Medicine and Health Sciences, Public and Occupational Health, Child Health
+
+Investigating strategies to enhance access to HIV services among children in Malawi: A multifaceted research approach, study protocol
+
+Investigating strategies to enhance access to HIV services among children in Malawi
+
+https://orcid.org/0009-0004-1202-0524 Matola Bilaal Wilson Conceptualization Data curation Formal analysis Investigation Methodology Project administration Software Validation Visualization Writing – original draft 1 2 *
+https://orcid.org/0000-0003-1158-6302 Nyasulu Juliet Charity Yauka Conceptualization Data curation Methodology Supervision Validation Writing – review & editing 1 3
+Nicol Edward Conceptualization Data curation Methodology Supervision Writing – review & editing 1 4
+1 Division of Health Systems and Public Health , Department of Global Health , Faculty of Medicine and Health Sciences , Stellenbosch University , Stellenbosch , South Africa
+2 Department of HIV, STIs and Viral Hepatitis , Ministry of Health , Lilongwe , Malawi
+3 AFRIQUIP, Health Systems Strengthening , Johannesburg , South Africa
+4 Burden of Disease Research Unit , South Africa Medical Research Council , Cape Town , South Africa
+Buh Amos Editor
+University of Ottawa , CANADA
+* E-mail: bwilson@hivmw.orgCompeting Interests: The authors have declared that no competing interests exist.
+
+Electronic publication date: 2026 Sep 3
+Publication date: 2026
+Volume: 21
+Issue: 9
+Electronic Location ID: e0357408
+Received 2026 Mar 26; Accepted 2026 Aug 17
+Copyright: © 2026 Matola et al
+Copyright year: 2026
+Copyright holder: Matola et al
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Investigating strategies to enhance access to HIV services among children in Malawi: A multifaceted research approach, study protocol. 21 9 3 9 2026 e0357408 e0357408 PLoS One 10.1371/journal.pone.0357408 42691038
+Investigating strategies to enhance access to HIV services among children in Malawi: A multifaceted research approach, study protocol. 21 9 3 9 2026 e0357408 e0357408 PLoS One 10.1371/journal.pone.0357408 42691038
+
+Funding: The author(s) received no specific funding for this work.
+
+Figure count: 1
+Table count: 2
+Page count: 21
+Data Availability: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
+
+Data Availability
+
+No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
+
+Ÿ==============================Ÿ
+Background
+
+Despite major progress in HIV epidemic control, children in sub-Saharan Africa, particularly in Malawi, continue to experience poorer HIV outcomes than adults. While Malawi has made substantial progress toward the UNAIDS 95-95-95 targets, only 55% of children living with HIV are virally suppressed compared with 87% of adults. This study aims to identify and develop strategies to improve children`s access to HIV services in Malawi.
+
+Methods
+
+Guided by the Socio-Ecological Model and the HIV care cascade framework, this multi-method study comprises four sub-studies: (1) secondary analysis of national HIV program data and spectrum estimates (2012–2023) to assess trends and progress toward the 95-95-95 targets; (2) a scoping review of health system interventions that improve paediatric HIV service access in sub-Saharan Africa (2015–2025). (3) a modified e-Delphi process with 15–30 experts to develop a context-appropriate intervention package and (4) a feasibility and acceptability assessment of the package at Kabudula Community Hospital, Lilongwe, Malawi, involving healthcare workers, community health workers, and caregivers using questionnaires and qualitative interviews.
+
+Ethical considerations
+
+Ethical approval will be obtained from Stellenbosch University Health Research Ethics Committee (HREC) and the Malawi National Health Sciences Research Ethics Committee. Written informed consent and confidentiality will be ensured.
+
+Conclusion
+
+This study will identify gaps in HIV care access among children, synthesize evidence on effective interventions, and develop a feasible, context-specific intervention package to strengthern children`s access to HIV services and accelerate Malawi`s progress toward achieving UNAIDS 95-95-95 targets.
+
+Introduction
+
+The HIV/AIDS epidemic remains a major global public health challenge despite remarkable progress in prevention, and treatment over the past three decades. Sub-Saharan Africa continues to bear the greatest burden of the epidemic, accounting for nearly two-thirds of all people living with HIV (PLHIV) worldwide [1,2]. Malawi, a low-income country in this region, remains one of the countries most affected by HIV. In 2024, the country reported an HIV prevalence of approximately 7.3% among adults aged 15 years and older and 0.6% among children under 15 years [3]. Although the scale up of HIV interventions has resulted in substantial declines in new infections and AIDS related mortality since the mid-1990s [1], important disparities in HIV outcomes persist across population groups.
+
+Global progress has been driven by coordinated efforts to expand access to HIV prevention, treatment and care services. Since its establishment in 1996, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has led the global response to HIV with the goal of ending AIDS as a public health threat by 2030 [4]. The UNAIDS Fast-Track strategy, launched in 2014, introduced the 95-95-95 targets, which aim for 95% of all people living with HIV to know their HIV positive status, 95% of those diagnosed with HIV to receive sustained antiretroviral therapy (ART), and 95% of those on treatment to achieve viral load suppression by 2025 [4].
+
+Globally, important gains have been made toward these targets. By 2023, 86% of people living with HIV globally knew their HIV status, 77% were receiving ART, and 72% had achieved viral suppression [1]. In sub-Saharan Africa, the corresponding figures were 93%, 83% and 78%, respectively [1].
+
+Malawi has made considerable progress towards these targets through its public health approach to HIV service delivery. Since adopting this approach in 2004 and implementing the UNAIDS 90-90-90 targets in 2015, later transitioning to the 95-95-95 targets in 2020, the country has substantially expanded HIV testing and treatment services [5]. By the end of the 90-90-90 implementation period, 88.4% of people living with HIV were aware of their HIV positive status, 97.8% of those diagnosed were receiving treatment, and 96.9% of those on treatment had achieved viral suppression [6]. These achievements demonstrate the strength of Malawi`s national HIV programme.
+
+Despite this progress, children continue to experience poorer outcomes than adults across the HIV care continuum [7,8]. In this study, children are defined as individuals younger than 15 years of age, consistent with the definitions adopted by the World Health Organization [9] and the Malawi National HIV Programme. The terms children and paediatric are used interchangeably throughout the manuscript. Children experience lower rates of HIV diagnosis, delayed ART initiation, poorer retention in care, suboptimal treatment adherence, and lower viral suppression than adults [10–15]. Access to HIV services is defined as the ability of children to obtain timely, equitable, and continuous HIV services across the care continuum, including HIV testing, diagnosis, linkage to care, ART initiation, retention in care, viral load monitoring, and achievement of sustained viral suppression [16]. Improving access therefore extends beyond the physical availability of services to include their accessibility, acceptability, affordability, and continuity throughout treatment. Achieving and sustaining epidemic control among children is critical, not only for improving child health outcomes but also for preventing HIV transmission and reducing the risk of drug resistance [17].
+
+These disparities are particularly evident in Malawi. While viral suppression among adults reached approximately 87% by the end of 2023, suppression among children was only about 55% [18]. Children continue to experience losses at every stage of the HIV care continuum, from HIV diagnosis and linkage to care to treatment initiation, retention, and long-term viral suppression [19]. These persistent gaps threaten Malawi`s progress towards achieving the UNAIDS 95-95-95 targets and underscore the need for strategies specifically tailored to children`s needs.
+
+Numerous health system interventions have been implemented globally and in Malawi to strengthen HIV service delivery, including decentralisation of HIV services [20], task shifting and task sharing [20], universal “test and treat” policies [21], integration of HIV services into primary healthcare [22,23], differentiated service delivery models [24], community-based HIV programmes [25], strengthened monitoring and evaluation systems [20], as well as innovative financing through global partnerships [26].
+
+Although these interventions have substantially improved HIV outcomes at the population level, children continue to lag because they face unique barriers, including delayed early infant diagnosis [27], poor linkage to treatment [28], inconsistent retention in care, dependence on caregivers, stigma, long travel distances [29], financial constraints, and socialeconomic disadvantage.
+
+Evidence suggests that interventions such as task shifting to lay health workers [30–33], integration of paediatric HIV services with maternal and child health services [25,34,35], expansion of point-of-care diagnostic technologies [36–42], decentralisation of ART services and differentiated service delivery models, have demonstrated potential for improving treatment uptake and retention among children [43–49].
+
+However, the evidence remains fragmented and highly context-specific, with limited sysnthesis of which interventions are most effective for improving access to HIV services among children in sub-Saharan Africa. Furthermore, few national studies have comprehensively analysed routine programme data to identify where children are being lost along the HIV care continuum in Malawi. Consequently, policymakers have limited evidence to guide the development of comprehensive and contextually appropriate strategies to improve HIV service delivery in children.
+
+Addressing these gaps requires more than a single methodological approach. National HIV epidemiological analyses can identify where service delivery gaps occur but cannot determine which interventions are most effective. Conversely, evidence from published studies can identify promising interventions but may not adequately reflect the Malawian context. Moreover, evidence-based interventions require prioritisation by stakeholders and assessment of their feasibility before implementation. An integrated research approach is therefore needed to combine epidemiological evidence, evidence synthesis, stakeholder consensus, and implementation assessment.
+
+Accordingly, this study adopts a sequential multi-method design comprising four complementary methodological components. First, a national epidemiological analysis will identify service delivery gaps across the paediatric HIV care continuum. Second, a scoping review will synthesise evidence on interventions that have improved access to HIV services among children in sub-Saharn Africa. Third, a modified Delphi process will engage key stakeholders to contextualise and prioritise these interventions for Malawi through expert consensus. Finally, a feasibility assessment will evaluate the acceptability, practicality, and implementation potential of the resulting intervention framework. Fig 1 summarises the interplay between the four sub studies.
+
+10.1371/journal.pone.0357408.g001 Fig 1 Conceptual workflow of the study.
+
+Illustrates the conceptual workflow of the study and the relationship between the individual sub studies.
+
+Together, these four components provide a coherent pathway from identifying service delivery gaps, to identifying evidence-based solutions, adapting them to the local context, and evaluating their readiness for implementation. By integrating epidemiological analysis, evidence synthesis, stakeholder consensus, and feasibility assessment, this study aims to develop an evidence-informed and contextually appropriate framework for improving access to HIV care services among children in Malawi. The findings will inform policy and programme implementation, strengthen children HIV service delivery, and ontribute to achieving equitable progress towards the UNAIDS 95-95-95 targets and ending AIDS as a public health threat by 2030. The main research question guiding this study is: How can an evidence-informed and contextually appropriate framework of strategies be developed to improve access to HIV care services among children in Malawi? The broad objective of this study is to develop and assess the possible feasibility of an evidence-informed, contextually appropriate framework for improving access to HIV services among children in Malawi. The following are the specific objectives: 1. To assess levels and trends in access to HIV services among children in Malawi in relation to progress toward the UNAIDS 95-95-95 targets. 2. To map, through a scoping review, health system interventions that have improved uptake of HIV services among children in sub-Saharan Africa. 3. To design and develop a context-appropriate intervention package to improve access to HIV services among children in Malawi. 4. To assess the possible feasibility and acceptability of the proposed intervention package at Kabudula Community Hospital in Lilongwe district, Malawi.
+
+Materials and methods
+
+This study will use a sequential multi-method study design [50]. The study comprises four interrelated sub-studies in line with the objectives. Below are the details:
+
+Sub-study 1: To examine the current level of access to HIV services and trend among children in Malawi in relation to achieving the UNAIDS 95-95-95 fast track targets
+
+Study design.
+
+This study employed a descriptive quantitative design [51] using secondary data derived from routinely collected Malawi national HIV programme database and UNAIDS spectrum estimates. The study systematically analysed existing programme data to describe temporal trends, quantify progress, and identify gaps in HIV service delivery across the HIV care continuum. Statistical analyses were conducted to objectively assess Malawi`s progress towards achieving the UNAIDS 95-95-95 targets, with particular emphasis on examining disparities in HIV testing, antiretroviral therapy (ART) coverage, and viral load suppression across key population subgroups, including age and sex. The use of routinely collected national data enabled a comprehensive evaluation of programme performance under real-world implementation conditions and provided evidence to inform policy and programme improvement.
+
+Data sources.
+
+This study utilized secondary data obtained from Malawi’s national HIV programme and UNAIDS spectrum estimates. Routine programme data were extracted from the Department of HIV/AIDS Management Information System (DHAMIS), the national repository for HIV programme data maintained by the Ministry of health. DHAMIS receives routinely reported, aggregated data from all health facilities providing HIV prevention, testing, treatment, and care services across the country. The analysis included programme data collected between 2012 and 2023, enabling the assessment of longitudinal trends in HIV service delivery and programme performance. To complement the routine programme data, UNAIDS spectrum estimates were used to obtain epidemiological parameters that are not routinely captured through health facility reporting, including national estimates of the total number of people living with HIV (PLHIV). Spectrum is a globally recognized mathematical modelling tool that generates country-specific HIV estimates by integrating surveillance, demographic, and programme data [52]. The combined use of routine programme data and spectrum estimates provided a more comprehensive assessment of Malawi`s progress towards the UNAIDS 95-95-95 targets by integrating observed programme performance with modelled population-level estimates.
+
+Study variables.
+
+The primary outcome variables were the three indicators of the UNAIDS 95-95-95 HIV care cascade: HIV status awareness, antiretroviral therapy (ART) uptake, and HIV viral load suppression. These indicators were assessed longitudinally to evaluate trends in HIV programme performance between 2012 and 2023. HIV status awareness was defined as the proportion of people living with HIV (PLHIV) who were aware of their HIV-positive status. ART uptake was defined as the proportion of individuals diagnosed with HIV who were receiving antiretroviral therapy. Viral load suppression was defined as the proportion of individuals receiving ART who achieved viral suppression, as defined by the Malawi National HIV Programme and UNAIDS monitoring guidelines. To assess equity in HIV service delivery, all outcome variables were disaggregated by age and sex. Age was categorized into children (under 15 years) and adults (15 years and older), consistent with national HIV programme reporting, while sex was categorized as male and female. Stratified analyses were undertaken to identify temporal differences in programme performance across demographic subgroups and to quantify disparities in access to HIV diagnosis, treatment and treatment outcomes. This disaggregation enabled the identification of population groups experiencing suboptimal performance across the HIV care continuum, thereby informing targeted policy and program interventions.
+
+Data analysis tools.
+
+Data were pre-processed through systematic cleaning, validation, and consistency checks to ensure completeness, accuracy and internal consistency prior to analysis. initial data management, including data verification, coding, and tabulation, was conducted using Microsoft Excel. Statistical analyses were performed using Stata version 15.1.
+
+Statistical analysis.
+
+Descriptive statistical analyses were conducted to summarize the characteristics of the study population and describe temporal trends in the three UNAIDS 95-95-95 indicators: HIV status awareness, antiretroviral therapy (ART) coverage, and viral load suppression. Categorical variables were summarized using frequencies and proportions, while trends in programme performance from 2012 to 2023 were presented graphically and in tabular form. Comparative analyses were undertaken to assess differences in HIV programme outcomes across demographic subgroups. For the 2023 cross-sectional analysis, proportions of HIV status awareness, ART coverage, and viral load suppression were compared by age group (children <15 years and adults ≥15 years) and sex. Pearson`s chi-square test was used to compare proportions between groups, while Fisher`s exact test was applied where expected cell counts were insufficient to satisfy the assumptions of the chi-square test. Corresponding 95% confidence intervals were reported for key proportions and estimated differences where appropriate. All statistical tests were two-sided, and statistical significance was determined using an alpha level of 0.05 (p < 0.05).
+
+Timelines.
+
+The UNAIDS 95-95-95 targets were originally set for achievement by December 2025. To maintain relevance to this timeline, this sub-study was completed and its findings published in May 2025. The full publication and data set are publicly accessible online at the following link: https://www.tandfonline.com/doi/abs/10.2989/16085906.2025.2477090.
+
+Sub study 2: To describe the landscape of health system interventions that have improved access to HIV services among children in sub-Saharan Africa
+
+Study design.
+
+This study will employ a scoping review design [53] to systematically map and synthesise the existing evidence on health system interventions that improve access to HIV services among children in sub-Saharan Africa. The review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews, which represents the current international standard for the conduct of scoping reviews and builds upon the foundational framework proposed by Arksey and O’Malley and its subsequent refinements [54,55]. Consistent with the JBI methodology, the review will follow a structured and iterative process comprising: (i) defining the review objectives and research question; (ii) developing and implementing a comprehensive search strategy; (iii) identifying and selecting eligible studies based on predefined inclusion and exclusion criteria; (iv) extracting and charting data using a standardised data extraction form; and (v) collating, summarising, and presenting the findings in relation to the review objectives. Throughout the review process, methodological decisions will be documented to ensure transparency, reproducibility, and methodological rigour. The review findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols Extension for Scoping Reviews (PRISMA-ScR), which provides guidance for the transparent and comprehensive reporting of scoping review methods and findings [56]. Adherence to the JBI methodology and PRISMA-ScR reporting standards will enhance the methodological quality, transparency, and reproducibility of the review.
+
+Patient and public involvement.
+
+This study will be conducted using previously published data and will not involve direct participation from patients at any stage. No patients will be recruited, interviewed, or subjected to any interventions as part of this research. Additionally, patient input will not be sought in the design, data collection, analysis, or dissemination of the study findings.
+
+Stage 1: Formulating the research question: An iterative approach, consistent with contemporary scoping review methodology was used to progressively refine the research question through ongoing engagement with co-investigators. This iterative refinement ensured conceptual clarity, scope alignment, and methodological coherence throughout the review process. The overarching review question is: Which health system interventions have been implemented to improve access to HIV services among children in sub- Saharan Africa?
+
+The review is further structured by the following specific questions:
+
+What types of health system interventions have been implemented to improve access to HIV services among children in sub-Saharan Africa?
+
+What are the key characteristics of these interventions, including delivery platforms, target populations, and implementation strategies?
+
+What outcomes have been reported in relation to child access to HIV services following implementation of these interventions?
+
+Stage 2: Identifying relevant studies: A comprehensive literature search will be conducted to identify studies reporting health system interventions that improve access to HIV services among children living with HIV in sub-Saharan Africa. The search strategy will be developed in consultation with an experienced health sciences librarian to maximise its sensitivity and reproducibility. Electronic databases to be searched will include PubMed/MEDLINE, Embase, WHO Global Index Medicus, Google Scholar, and Web of Science. In addition, backward and forward citation tracking of all included studies and relevant review articles will be undertaken to identify additional eligible studies not retrieved through database searching.
+
+The review focuses on interventions implemented following the introduction of the UNAIDS Fast-Track (90-90-90) targets in 2014, which marked a shift towards targeted strategies for improving performance across the HIV care cascade [4]. Accordingly, studies published between 1 January 2015 and 31 July 2025 will be considered for inclusion.
+
+The search strategy will be developed using the Population-Concept-Context (PCC) framework, which is recommended by the Joanna Briggs Institute for scoping reviews. Search terms will be identified through an iterative process involving the review question, Medical Subject Headings (MeSH), database specific subject headings, and relevant free text keywords. Search terms will encompass three domains: (i) Population (e.g., “child*”, “paediatric HIV”, “pediatric HIV”, “infant*”, “HIV-exposed children”); (ii) Concept (e.g., “health system*”, “health service*”, “intervention*”, “service delivery”, “access”, “linkage”, “retention”, “viral suppression”); and (iii) Context (e.g., “sub-Saharan Africa” and the names of individual countries within the region). Although terms such as “adolescent” may be included during the initial search to increase search sensitivity and account for studies that report combined paediatric populations, only data relating to children aged 0–14 years will be eligible for inclusion during study selection.
+
+Pilot searches will be conducted to refine the search syntax for each database, and the final search strategies will be adapted to the indexing requirements of individual databases. The complete electronic search strategy for each database will be provided to ensure transparency and reproducibility. Table 1 shows detailed search strategy for PUBMED.
+
+10.1371/journal.pone.0357408.t001 Table 1 Detailed PubMed search strategy.
+
+Component	Description	
+Review question	What health system interventions have been implemented to improve access to HIV services among children in sub-Saharan Africa?	
+Framework	Population–Concept–Context (PCC) framework as recommended by the Joanna Briggs Institute (JBI) for scoping reviews.	
+Population	Children (<15 years), including infants, children, adolescents, paediatric populations, and newborns living with or at risk of HIV infection.	
+Concept	Health system interventions implemented to improve access to HIV services, including interventions related to service delivery, health systems strengthening, health policy, healthcare accessibility, programme evaluation, and healthcare interventions.	
+Context	Countries in sub-Saharan Africa.	
+Database	PubMed	
+Publication period	1 January 2015 to 31 July 2025	
+Language	English	
+Search fields	Medical Subject Headings (MeSH) and Title/Abstract (tiab) fields.	
+Search approach	Controlled vocabulary (MeSH) and free-text terms were combined using Boolean operators. Synonymous terms within each concept were combined using OR, while the four concepts (HIV, health system interventions, children, and sub-Saharan Africa) were combined using AND. Truncation (*) was used where appropriate to capture variations of search terms.	
+Concept 1: HIV services	MeSH terms: “HIV Infections”[Mesh]Keywords: HIV, “HIV services”, “HIV care”, “HIV treatment”, “HIV testing”, “HIV diagnosis”, “HIV cascade”, “antiretroviral therapy”, ART	
+Concept 2: Health system interventions	MeSH terms: “Health Services”[Mesh], “Health Systems”[Mesh], “Health Policy”[Mesh], “Delivery of Health Care”[Mesh], “Health Services Accessibility”[Mesh], “Program Evaluation”[Mesh]Keywords: “Healthcare Interventions”, “health system strengthening”, “service delivery”, “healthcare access”, “health service intervention*”, “system intervention*”	
+Concept 3: Children	MeSH terms: “Child”[Mesh], “Infant”[Mesh], “Adolescent”[Mesh]Keywords: child*, pediatric*, paediatric*, adolescent*, infant*, newborn*	
+Concept 4: Geographic setting	MeSH term: “Africa South of the Sahara”[Mesh]Keywords: “sub-Saharan Africa”, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Djibouti, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.	
+Complete PubMed search string	(("HIV Infections"[Mesh] OR HIV[tiab] OR "HIV services"[tiab] OR "HIV care"[tiab] OR "HIV treatment"[tiab] OR "HIV testing"[tiab] OR "HIV diagnosis"[tiab] OR "HIV cascade"[tiab] OR "antiretroviral therapy"[tiab] OR ART[tiab]) AND ("Health Services"[Mesh] OR "Health Systems"[Mesh] OR "Health Policy"[Mesh] OR "Delivery of Health Care"[Mesh] OR "Health Services Accessibility"[Mesh] OR "Program Evaluation"[Mesh] OR "Healthcare Interventions"[tiab] OR "health system strengthening"[tiab] OR "service delivery"[tiab] OR "healthcare access"[tiab] OR "health service intervention*"[tiab] OR "system intervention*"[tiab]) AND ("Child"[Mesh] OR "Infant"[Mesh] OR "Adolescent"[Mesh] OR child*[tiab] OR pediatric*[tiab] OR paediatric*[tiab] OR adolescent*[tiab] OR infant*[tiab] OR newborn*[tiab]) AND ("Africa South of the Sahara"[Mesh] OR "sub-Saharan Africa"[tiab] OR Angola[tiab] OR Benin[tiab] OR Botswana[tiab] OR "Burkina Faso"[tiab] OR Burundi[tiab] OR Cameroon[tiab] OR "Cape Verde"[tiab] OR "Central African Republic"[tiab] OR Chad[tiab] OR Comoros[tiab] OR Congo[tiab] OR "Côte d'Ivoire"[tiab] OR Djibouti[tiab] OR "Equatorial Guinea"[tiab] OR Eritrea[tiab] OR Eswatini[tiab] OR Ethiopia[tiab] OR Gabon[tiab] OR Gambia[tiab] OR Ghana[tiab] OR Guinea[tiab] OR "Guinea-Bissau"[tiab] OR Kenya[tiab] OR Lesotho[tiab] OR Liberia[tiab] OR Madagascar[tiab] OR Malawi[tiab] OR Mali[tiab] OR Mauritania[tiab] OR Mozambique[tiab] OR Namibia[tiab] OR Niger[tiab] OR Nigeria[tiab] OR Rwanda[tiab] OR "Sao Tome and Principe"[tiab] OR Senegal[tiab] OR Seychelles[tiab] OR "Sierra Leone"[tiab] OR Somalia[tiab] OR "South Africa"[tiab] OR "South Sudan"[tiab] OR Sudan[tiab] OR Tanzania[tiab] OR Togo[tiab] OR Uganda[tiab] OR Zambia[tiab] OR Zimbabwe[tiab]))	
+Table 1 presents the detailed search strategy to be used to identify relevant studies in PubMed, including the search terms, Boolean operators, and search combinations applied.
+
+The review will be restricted to studies published in English because of resource limitations for translation. This restriction may introduce language bias and result in the omission of relevant evidence published in other langauges; therefore, this limitation will be acknowledged when interpreting the findings.
+
+Eligibility criteria: Eligibility criteria will be established using the Population, Concept, and Context (PCC) framework: Population: Children (aged 0–14 years) living with HIV. Concept: Health system interventions designed to improve access to HIV services across the HIV care continuum including HIV testing, linkage to care, treatment initiation, retention in care, adherence, and viral load monitoring or suppression. Context: Healthcare facilities and community based service delivery settings in countries within sub–Saharan Africa.
+
+The review will include peer-reviewed primary research studies employing quantitative, qualitative, or mixed-methods designs, including randomized controlled trials, quasi-experimental studies, cohort studies, case-control studies, cross-sectional studies, implementation studies, and qualitative research. Editorials, commentaries, opinion papers, conference abstracts without full-text publications, and narrative reviews will be excluded. Table 2 summarises the study eligibility criteria.
+
+10.1371/journal.pone.0357408.t002 Table 2 Study eligibility criteria.
+
+Eligibility domain	Criteria	
+Language	Studies published in English only	
+Population	Children aged 0–14 years living with HIV.	
+Concept	Health system interventions designed to improve access to HIV services across the HIV care continuum, including HIV testing, linkage to care, treatment initiation, retention in care, adherence, and viral load monitoring or viral suppression.	
+Context	Healthcare facilities and community-based service delivery settings in sub-Saharan African countries.	
+Study designs included	Peer-reviewed primary research employing quantitative, qualitative, or mixed-methods designs, including randomized controlled trials, quasi-experimental studies, cohort studies, case-control studies, cross-sectional studies, implementation studies, and qualitative research.	
+Publication types excluded	Editorials, commentaries, opinion papers, conference abstracts without full-text publications, and narrative reviews.	
+Eligibility framework	Population–Concept–Context (PCC) framework.	
+Table 2 summarises the inclusion and exclusion criteria used to determine eligibility of studies for the review.
+
+Stage 3: Selecting studies: Study selection will follow the recommendations of the Joanna Briggs Institute for scoping reviews and will be reported using the PRISMA-ScR flow diagram. All retrieved records will be imported into EndNote for reference management and duplicate removal before being transferred to Rayyan application [57] to facilitate independent screening. Prior to formal screening, the review team will conduct a calibration exercise using a sample of studies to ensure consistent interpretation and application of the eligibility criteria.
+
+Two reviewers will independently screen titles and abstracts against the predefined PCC based eligibility criteria. Studies considered potentially eligible will undergo full text assessment by the same reviewers. Any disagreements at either stage will be resolved through discussion and consensus. Where consensus can not be reached, a third reviewer will adjudicate.
+
+For studies with multiple publications, reports will be collated and treated as a single study, with the most comprehensive and up to date publication serving as the primary reference while extracting relevant information from companion publications where necessary. The reason for excluding studies at the full text screening stage will be documented, and the complete study selection process will be presented in a PRISMA-ScR flow diagram to ensure transparency and reproducibility.
+
+Stage 4: Extracting data: The Joanna Briggs Institute’s data extraction tool template will be used to extract relevant data. Key details will be gathered from the selected studies, including the publication year, country and context, study design, conceptual framework, objectives, methods, and findings.
+
+To ensure the validity of the process, the extraction form will be piloted, tested on a few studies, and discussed with co-investigators. Two independent reviewers will then extract the data, and any disagreements will be resolved by consulting a third reviewer.
+
+Stage 5: Collating, summarising and reporting the outcomes: Data collation and organization. The extracted data will be systematically collated in a structured manner to ensure a comprehensive synthesis of findings. Studies will be categorized based on the type of health system intervention, geographical location, study design, population characteristics, and key outcomes. Interventions will be further grouped into thematic areas such as healthcare workforce interventions, service delivery modifications, policy and governance changes, and community-based initiatives. Descriptive statistics and narrative synthesis will be used to summarize the data.
+
+Summarising key findings. The number of studies that met the inclusion criteria and were analysed will be listed. The general overview of the findings will be summarized and shared and specific interventions that improved access to HIV services will be listed and elaborated.
+
+Reporting the outcomes. The outcomes of the scoping review will be presented using tables and thematic analysis. A summary of key interventions, their mechanisms of impact, and associated HIV services access improvements among children will be provided. The evidence base will be assessed for gaps, highlighting areas where further research is needed, such as the long-term sustainability of interventions and their adaptability across different healthcare settings.
+
+Status and timeline of the scoping review.
+
+The literature search for this scoping review commenced in the last quarter of 2025. Title and abstract screening will be completed in July 2026. Full-text screening will be done between August and October 2026. Data extraction is planned for November 2026. The final results of the review are expected to be available in December 2026.
+
+Sub study 3: To design and develop a context-appropriate intervention package that can be used to improve access to HIV services among children in Malawi
+
+Study design.
+
+This study will employ a modified electronic Delphi (e-Delphi) approach [58] to develop a consensus based package of health system interventions to improve access to HIV services among children (0–14 years) living with HIV in Malawi. The electronic Delphi approach was selected because it enables structured consensus building among geographically dispersed experts while maintaining anonymity, reducing the influence of dominant individuals, and allowing participants to reconsider their opinions in light of controlled group feedback.
+
+A Multidisciplinary steering committee comprising three to five members, including the principal investigator and co-investigators, will oversee the study. Members will have expertise in paediatric HIV, implementation science, health systems research, epidemiology and public health, with at least one member possessing extensive experience in HIV service delivery within Malawi. The steering committee will be responsible for refining the Delphi questionnaires, monitoring the Delphi process, reviewing qualitative feedback, and ensuring methodological rigour. Steering committee members will facilitate the process but will not participate as Delphi panellists.
+
+Evidence generated from sub study 2 (the scoping review) will provide the initial list of candidate interventions for the modified eDelphi process. The scoping review will synthesize intervention characteristics, including intervention components, target populations, implementation settings, reported effectiveness, implementation barriers and facilitators and contextual considerations. These findings will form the basis of the round 1 questionnaire.
+
+Phase 1: Expert panel selection and recruitment: A purposive maximum-variation sampling strategy [59] will be used to recruit a multidisciplinary panel representing the breadth of paediatric HIV expertise in Malawi. Eligibility criteria: Experts will be eligible if they: have at least five years` experience in paediatric HIV care, HIV programme implementation, HIV policy development, health systems strengthening, implementation research, or community based HIV programming; currently work or have worked within Malawi during the previous five years; hold positions within government, academia, implementing partners, professional associations, health facilities, or civil society organizations involved in paediatric HIV; demonstrate evidence of expertise through senior professional responsibilities, peer-reviewed publications, national HIV technical working group membership, programme leadership, or recognized technical experience; and are willing to participate in all Delphi rounds.
+
+Individuals unable to commit to repeated rounds or whose expertise lies outside paediatric HIV or health systems strengthening will be excluded. To minimize selection bias, experts will be identified from multiple independent sources, including ministry of health (HIV) technical working group membership lists, professional associations, university departments, implementing partners, civil society organisations, and authorship of relevant peer reviewed publications. Professional networks of the investigators` will be used only to supplement these sources rather than serving as the primary recruitment strategy.
+
+Approximately 20–30 experts will be recruited. This range is consistent with recommendations for heterogeneous Delphi panels while allowing for anticipated attrition across successive rounds [60].
+
+Eligible experts will receive an electronic invitation containing the participant information sheet, consent form, study timeline, and estimated time commitment.
+
+Phase 2: Questionnaire development and pilot testing (round 1 questionnaire): The Round 1 questionnaire will be developed directly from the interventions identified in the scoping review. Each intervention will include: a standardized description; target population; implementation setting; evidence summary; and anticipated implementation considerations. Experts will independently assess each intervention using a 5-point Likert scale for: relevance to improving access to HIV services among children in Malawi; feasibility within the Malawian health system. Open-ended questions will accompany every intervention to allow participants to: justify their ratings; identify implementation barriers and facilitators; recommend modifications; and propose additional interventions not identified during the scoping review.
+
+Prior to administration, the questionnaire will undergo content validation by the steering committee and pilot testing with 5–8 individuals who meet the expert eligibility criteria but will not participate in the Delphi panel. The pilot will evaluate clarity, completeness, questionnaire length, usability of the electronic platform, and interpretation of rating scales. Feedback from the pilot will be incorporated before Round 1 is launched.
+
+Phase 3: Delphi consensus rounds: The Delphi process will be conducted electronically using a secure online survey platform that preserves participant anonymity throughout all rounds. Each round will remain open for two to three weeks, with reminder emails sent after one and two weeks.
+
+Round 1. Experts will independently rate all interventions. Quantitative analysis will include: median scores; interquartile ranges (IQR); and percentage agreement. Qualitative responses will undergo thematic content analysis to identify suggested modifications, implementation concerns, and newly proposed interventions.The steering committee will revise intervention wording where clarification is required and incorporate newly proposed interventions that align with the study objectives.
+
+Round 2. Each participant will receive individualized feedback comprising: their previous rating; the panel median; the interquartile range; percentage agreement; and an anonymized summary of panel comments. Experts will then reconsider and re-rate each intervention. New interventions generated during Round 1 will be introduced for initial rating.
+
+Round 3. Only interventions failing to achieve consensus during Round 2 will be re-rated. Participants will again receive anonymized statistical summaries and qualitative feedback before providing their final ratings.
+
+Consensus definition: Consensus will be defined a priori using all of the following criteria: median rating ≥4 for both relevance and feasibility; interquartile range (IQR) ≤1; and at least 75% of participants assigning ratings of 4 or 5. Interventions meeting all three criteria will be considered to have achieved consensus for inclusion. Interventions failing to satisfy these criteria after the final Delphi round will be classified as having no consensus and will not be included automatically in the final intervention package.
+
+Stopping rule: The Delphi process will conclude when one of the following occurs: all interventions have reached either consensus or non-consensus classification; three Delphi rounds have been completed; or the proportion of interventions changing consensus status between consecutive rounds falls below 10%, indicating response stability. No more than three rounds are anticipated because additional rounds generally provide limited improvements while increasing participant fatigue.
+
+Phase 4: Development of the intervention package: Interventions reaching consensus will be synthesized into a comprehensive package organized according to: level of health service delivery (community, primary care, district hospital, tertiary care); stage of the paediatric HIV cascade (testing, linkage, ART initiation, retention, adherence, viral suppression); and health system building blocks where appropriate.
+
+Each intervention will include: implementation rationale; expected mechanism of action; implementation requirements; contextual facilitators; anticipated barriers; recommendations for adaptation within Malawi. A conceptual implementation framework describing integration within existing HIV services will also be developed.
+
+Stakeholder dissemination and validation: Following completion of the Delphi process, a separate stakeholder dissemination workshop will be convened with policymakers, programme managers, implementing partners, civil society representatives, and interested Delphi panelists. This workshop will not constitute an additional Delphi round and will not modify the consensus findings. Rather, its purpose will be to discuss implementation considerations, identify resource and policy implications, and enhance stakeholder ownership of the intervention package. By separating dissemination from consensus generation, participant anonymity and the methodological independence of the Delphi process will be preserved.
+
+Reporting.
+
+The study will be reported in accordance with the CREDES reporting recommendations for Delphi studies [61]. Recruitment, participant characteristics, response rates, attrition, questionnaire modifications, consensus outcomes, and reasons for non-consensus will be documented transparently. Both quantitative consensus statistics and qualitative findings will be presented to support the final intervention package.
+
+Timeline for this sub study.
+
+Participants recruitment is scheduled for December 2026, followed by data collection in the next three months. Final findings of this sub study would be available in June 2027.
+
+Sub study 4: Assessing possible feasibility and acceptability of the proposed package of interventions to improve access to HIV services among children at Kabudula rural hospital, Lilongwe district, Malawi
+
+Study design.
+
+This sub study will employ a convergent mixed-methods case study design to assess the perceived feasibility and acceptability of the intervention package developed in sub study number three. A convergent design is appropriate because quantitative and qualitative data will be collected during the same study period, analysed separately, and integrated during interpretation to provide a comprehensive understanding of implementation outcomes. The intervention package will be presented through standardised three to seven-minute video scenarios demonstrating how the proposed interventions could be implemented within routine paediatric HIV services delivery points. The videos will ensure that all participants receive identical information before data collection, thereby reducing variability in interpretation of the intervention package.
+
+The quantitative component will measure perceived acceptability, appropriateness and feasibility using validated implementation outcome measures adapted from the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) [62].
+
+The qualitative component will explore participants’ explanations for their ratings, contextual implementation barriers and facilitators, and recommendations for improving the intervention package.
+
+Integration of quantitative and qualitative findings will occur during interpretation using joint displays and narrative triangulation. Quantitative findings will identify the level of perceived implementation outcomes, while qualitative findings will explain the reasons underlying these perceptions and provide contextual insights to refine the intervention package.
+
+Study setting.
+
+The study will be conducted at Kabudula community hospital in Lilongwe district, Malawi. The hospital was purposively selected because it provides comprehensive children HIV services across both facility and community platforms, including collaboration with community health workers. The hospital serves a predominantly rural population facing many of the barriers to paediatric HIV service access identified in previous sub studies including long travel distances, socioeconomic constraints and health workforce shortages.
+
+As an information-rich case, the site provides an appropriate setting for an in-depth feasibility assessment before wider implementation.
+
+Although findings may not be statistically generalisable to all Malawian settings, the purpose of this case study is to generate contextually relevant implementation evidence and identify practical considerations that can inform future multi-site evaluation.
+
+Study population.
+
+Three stakeholder groups will participate: Healthcare workers involved in paediatric HIV care, community healthcare workers supporting HIV service delivery, caregivers of children aged 0–14 years receiving HIV services.
+
+To improve the relevance of the intervention scenarios, caregivers will be stratified according to children’s developmental stages (0–4, 5–9 and 10–14 years). Separate video modules will therefore be developed for each caregiver group, while distinct modules will be developed for facility-based healthcare workers and community healthcare workers.
+
+Sampling strategy.
+
+A purposive maximum-variation sampling will be used to ensure representation of diverse experiences across participant groups [59].
+
+Sample size.
+
+Quantitative component: The quantitative survey is intended to estimate perceived implementation outcomes rather than test intervention effectiveness. Consequently, sample size has been guided by recommendations for implementation feasibility studies rather than formal hypothesis testing.
+
+Approximately: 20 healthcare workers, 20 community healthcare workers and 30 caregivers (10 per child age category) will complete the AIM/IAM/FIM questionnaire.
+
+This sample is considered sufficient to provide stable descriptive estimates of implementation outcomes across stakeholder groups while remaining feasible within a single-site implementation assessment.
+
+Qualitative component: Qualitative sample sizes have been guided by the principle of information power, whereby richer information from participants with direct experience requires fewer participants. Approximately: 15–20 individual interviews with healthcare workers, 15–20 individual interviews with community healthcare workers, three focus group discussions comprising 6–8 caregivers each will be conducted.
+
+Recruitment will continue until thematic saturation is achieved, defined as the point at which no substantively new themes emerge from successive interviews [63].
+
+Participants recruitment.
+
+Healthcare workers will receive study information during routine morning handover meetings. Recruitment will occur subsequently through individual invitations to minimise perceived pressure to participate.
+
+Caregivers will receive general information during routine clinic health education sessions. Interested caregivers will subsequently contact the research team independently or meet study staff after clinic activities. Focus groups will be scheduled on dates separate from routine clinic appointments to minimise perceptions that participation could influence clinical care.
+
+Data collection procedures.
+
+Participants will first watch the standardised intervention video relevant to their stakeholder group. Immediately afterwards, participants will complete the quantitative AIM/IAM/FIM questionnaire. Following questionnaire completion: healthcare workers and community healthcare workers will participate in semi-structured individual interviews; caregivers will participate in focus group discussions. Collecting questionnaire responses before qualitative interviews will reduce the influence of group discussion on participants’ initial implementation ratings. Interview guides will be informed by implementation science frameworks and will explore: acceptability; feasibility; contextual appropriateness; implementation barriers; implementation facilitators; and recommendations for improving the intervention package.
+
+All interviews will be audio-recorded with consent and supplemented by field notes documenting contextual observations.
+
+Development and pilot testing of data collection tools.
+
+Questionnaires and interview guides will be informed by findings from Sub-studies 2 and 3 together with established implementation outcome frameworks. All instruments will undergo: expert review for content validity; translation into Chichewa and independent back-translation; pilot testing among participants with similar characteristics who will not participate in the main study. Pilot testing will assess clarity, comprehension, cultural appropriateness, interview duration and questionnaire usability. Necessary revisions will be made before data collection begins.
+
+Strategies to minimise bias.
+
+Several measures will be implemented to reduce potential sources of bias.
+
+Social desirability bias: Because participants are evaluating interventions developed through this research, several safeguards will be implemented. Participants will be assured that there are no correct or incorrect answers. Questionnaires will be completed anonymously using participant identification numbers rather than names. Participants will be informed that their responses will not influence their employment or access to healthcare services. Interviews will emphasize both positive and negative experiences, with interviewers actively encouraging criticism and suggestions for improvement. Healthcare workers and caregivers will be interviewed separately to minimise hierarchical influences.
+
+Researcher bias: To reduce interviewer bias and enhance trustworthiness: trained independent qualitative research assistants, rather than the principal investigator alone, will conduct interviews and focus group discussions after receiving standardised training; interviewers will follow a structured interview guide; transcripts will be independently coded by at least two researchers; discrepancies will be resolved through discussion and consensus; an audit trail documenting coding decisions will be maintained; reflexive memos will be recorded throughout data collection and analysis. The principal investigator will oversee quality assurance but will not serve as the sole interviewer or coder.
+
+Data analysis.
+
+Quantitative analysis: Questionnaire responses will be analysed using descriptive statistics. Median scores, interquartile ranges and percentages of participants agreeing or strongly agreeing with each AIM, IAM and FIM item will be calculated separately for each stakeholder group.
+
+Internal consistency of each implementation measure will be assessed using Cronbach’s alpha [64].
+
+Qualitative analysis: Interview and focus group transcripts will undergo reflexive thematic analysis. Two researchers will independently code transcripts before jointly developing a coding framework. Themes describing implementation barriers, facilitators and recommendations will then be generated.
+
+Mixed-methods integration: Integration will occur after completion of the separate quantitative and qualitative analyses.
+
+A joint display matrix will be used to compare implementation outcome scores with qualitative themes explaining those scores. Areas of convergence, complementarity and divergence will be identified to develop an integrated interpretation of intervention feasibility and acceptability. The integrated findings will inform refinement of the intervention package prior to future implementation studies.
+
+Timeline for this sub study
+
+Participants recruitment shall start in July 2027. Data collection will start in the same month and extend to the next three to four months. Results are expected to be available towards the end of 2027.
+
+Conceptual framework
+
+The Socio-Ecological Model (SEM) [65] is the conceptual framework guiding this study. It draws from the HIV care cascade to identify and integrate evidence-based interventions that influence paediatric HIV service uptake across multiple levels of influence. This framework acknowledges that improving HIV services uptake among children requires coordinated interventions addressing individual, interpersonal, community, institutional, and policy-level barriers.
+
+HIV care cascade framework guides the focus of interventions across critical stages namely HIV testing and diagnosis, linkage to care, initiation of ART, retention in care, and viral suppression.
+
+Interventions at individual and interpersonal level focus on improving knowledge, motivation, and behaviour among children and their caregivers, for example peer support for caregivers [66], SMS reminders for appointments/adherence [67], school-based HIV education and testing [68] and cash transfers to improve caregiver capacity and access [69]. Interventions at community level will address stigma, social norms, and community engagement, examples are community health worker follow-up and psychosocial support [70], and home-based HIV counselling and testing [71].
+
+Interventions at institutional/health system level will focus on improving service delivery, access, and quality of care, for example point of care early infant diagnosis (POC-EID) [72], family centred index case testing [73], service integration into routine child health/immunization clinics [74,75], and task shifting to trained lay health workers [76].
+
+Interventions at policy and structural level will create enabling environments through supportive policies, funding, and infrastructure, examples are supportive national paediatric HIV strategies, harmonized guidelines for integration and task-shifting and investment in health information systems and digital tools.
+
+The interventions, when packaged and implemented together, are hypothesized to increase early identification of HIV-positive children (via HBHCT, family testing, and school outreach), strengthen linkage to care (through CHW support, SMS reminders), accelerate ART initiation (via POC-EID and integration into routine care), improve retention and adherence (through caregiver support, CHWs, cash transfers) and ultimately improve health outcomes and achieve higher rates of viral suppression in children.
+
+Ethical considerations
+
+Ethical approval for the overall study will be obtained from the Health Research Ethics Committee of Stellenbosch University and the Malawi National Health Sciences Research Ethics Committee (NHSRC). Administrative permission will also be obtained from the Malawi Ministry of Health’s Department of HIV and AIDS.
+
+Sub-study 1 analysed secondary, fully anonymised national HIV programme data containing no personally identifiable information and involving no direct participant contact. Individual informed consent was therefore not required. Data are stored on encrypted, password-protected systems accessible only to authorised study personnel and used solely for research purposes. Findings were reported in aggregate to ensure confidentiality.
+
+Sub-study 2 is a scoping review based exclusively on published, de-identified literature and does not involve human participants. Consequently, individual informed consent is not required. Institutional ethical approval will nevertheless be obtained in accordance with Stellenbosch University and NHSREC requirements.
+
+Sub-studies 3 and 4 involve human participants and will be conducted only after obtaining ethical approval from both ethics committees. Written informed consent will be obtained from all participants before data collection. Participants will receive information about the study objectives, procedures, potential risks and benefits, confidentiality measures, and their right to decline participation or withdraw at any time without consequence. All data will be anonymised, with personal identifiers removed from transcripts and study records, and interviews and focus group discussions will be conducted in private settings to safeguard confidentiality. The study presents minimal risk to participants, while the anticipated benefits include contributing evidence to strengthen access to paediatric HIV services in Malawi.
+
+Discussion
+
+This study is expected to generate evidence to inform strategies for improving access to HIV services among children in Malawi. The first sub-study assessed national progress towards the UNAIDS 95-95-95 targets and identified disparities across the HIV care continuum.
+
+Although overall programme performance demonstrated substantial progress, disaggregated analyses revealed persistent inequities, particularly among children aged 0–14 years. Identifying these gaps will help prioritise populations requiring targeted interventions and guide equitable programme strengthening.
+
+The second sub-study will synthesise evidence on health system interventions implemented to improve paediatric HIV service access in sub-Saharan Africa. By mapping intervention characteristics, implementation approaches, and reported outcomes, the review will identify strategies with potential applicability to Malawi while highlighting important evidence gaps requiring further investigation.
+
+The third and fourth sub-studies will translate these findings into practice through the development and assessment of a context-specific intervention package. Integrating evidence from national programme data, the scoping review, and stakeholder consensus will ensure that the proposed package is evidence-informed and tailored to the Malawian health system. Assessing its possible feasibility and acceptability will provide valuable implementation insights to inform future piloting and scale-up. Collectively, the four sub-studies will generate complementary evidence to support the design of effective, contextually appropriate strategies for strengthening paediatric HIV service delivery in Malawi.
+
+Strengths and limitations of the study
+
+A major strength of this study is its integrated multi-methods design, which combines national programme data analysis, evidence synthesis, and stakeholder-informed intervention development. This sequential approach enables the study to move beyond describing service gaps to identifying evidence-based solutions and assessing their implementation potential. The intervention package will be informed by empirical national data, regional evidence, and expert consensus, enhancing its relevance, feasibility, and potential for policy translation within the Malawian context.
+
+Several limitations should be acknowledged. The first sub-study relies on routinely collected aggregate programme data, which may contain inaccuracies, missing values, or reporting inconsistencies. These limitations were mitigated by using validated national datasets and conducting data quality checks before analysis.
+
+The scoping review is restricted to studies conducted in sub-Saharan Africa and published in English. While this may exclude relevant evidence from other low- and middle-income countries and non-English publications, the review is designed to maximise contextual relevance to Malawi.
+
+The Delphi process may be affected by challenges in recruiting and retaining busy experts and by the potential for facilitator influence during consensus development. These risks will be minimised through careful participant engagement, structured communication, anonymous survey rounds, and standardised presentation of feedback to preserve neutrality throughout the consensus process.
+
+Conclusion
+
+Despite substantial progress in HIV prevention, treatment, and care, children in Malawi continue to experience significant gaps across the HIV care continuum, limiting progress toward the UNAIDS 95–95–95 targets and the goal of ending AIDS as a public health threat. Addressing these inequities requires robust evidence on existing service delivery gaps and effective, contextually appropriate strategies to improve access to HIV services for children.
+
+This multifaceted study combines analysis of national HIV programme data, a scoping review of health system interventions in sub-Saharan Africa, and the co-design and evaluation of a context-specific intervention package for Malawi. By generating evidence on paediatric HIV programme performance, synthesizing effective health system interventions, and assessing their feasibility and acceptability within the Malawian context, the study will provide actionable evidence to strengthen paediatric HIV service delivery. The findings are expected to inform policy and programme implementation, improve access to HIV services for children, and support Malawi`s progress toward sustained epidemic control.
+
+DOI: 10.1371/journal.pone.0357408.r001
+
+Author response to Decision Letter 0
+
+Submission Version: 0
+
+Transfer Alert
+
+This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.
+
+26 Mar 2026
+
+DOI: 10.1371/journal.pone.0357408.r002
+
+Decision Letter 0
+
+Buh Amos Academic Editor
+Copyright: © 2026 Amos Buh
+Copyright year: 2026
+Copyright holder: Amos Buh
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 0
+
+29 Jun 2026
+
+Dear Dr. Matola,
+
+Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
+
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+
+We look forward to receiving your revised manuscript.
+
+Kind regards,
+
+Amos Buh, BSc., MPH, PhD
+
+Academic Editor
+
+PLOS One
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+Reviewers' comments:
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+Reviewer's Responses to Questions
+
+Comments to the Author
+
+1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?
+
+Reviewer #1: Partly
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>
+
+Reviewer #1: Partly
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>
+
+Reviewer #1: No
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+4. Have the authors described where all data underlying the findings will be made available when the study is complete??>
+
+The PLOS Data policy
+
+Reviewer #1: No
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+5. Is the manuscript presented in an intelligible fashion and written in standard English??>
+
+Reviewer #1: No
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.
+
+You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.
+
+Reviewer #1: Overall assessment
+
+This manuscript addresses an important and policy-relevant public health problem: persistent inequities in access to HIV services among children in Malawi despite substantial national progress in adult HIV epidemic control. The topic is timely, relevant, and potentially suitable for PLOS ONE as a protocol manuscript.
+
+The proposed multi-phase approach combining secondary epidemiological analysis, scoping review, expert consensus development, and feasibility assessment has conceptual merit. However, in its current form, the manuscript has major methodological, structural, and reporting weaknesses that substantially limit confidence in its scientific rigor, reproducibility, and suitability for publication.
+
+The most significant concerns relate to protocol coherence, internal inconsistencies regarding study status, insufficient methodological precision, weak justification for the integrated design, concerns regarding the feasibility assessment methodology, and incomplete adherence to PLOS reporting expectations.
+
+Major comments
+
+1. Study rationale and research question
+
+The manuscript addresses a valid and important academic and public health problem. The disparity between adult and paediatric HIV outcomes in Malawi provides a strong rationale for the study .
+
+However, the research question remains too broad and insufficiently operationalized. Terms such as “access” and “approaches” are not clearly defined, making the precise scope of inquiry unclear. It is not explicit whether the study focuses primarily on HIV testing, diagnosis, ART initiation, retention in care, viral suppression, health systems strengthening, or implementation strategies.
+
+The manuscript would also benefit from a stronger justification for the claimed evidence gap, particularly the assertion that there is limited systematic evidence on effective interventions in this area.
+
+In addition, the rationale for combining four distinct methodological studies into a single protocol is not sufficiently articulated. While the individual components are understandable, the manuscript does not clearly explain the overarching logic linking:
+
+* national epidemiological analysis,
+
+* evidence synthesis,
+
+* Delphi consensus development,
+
+* and feasibility assessment.
+
+A clear conceptual workflow or logic model is needed.
+
+2. Protocol coherence and study status
+
+A major concern is inconsistency regarding the protocol’s status.
+
+This manuscript is presented as a prospective study protocol, yet:
+
+* Sub-study 1 is described as already completed and published.
+
+* Sub-study 2 appears partially completed.
+
+* Other components remain prospective.
+
+This creates substantial ambiguity regarding whether this is:
+
+* a true protocol,
+
+* a hybrid progress report,
+
+* or a doctoral programme methods overview.
+
+Completed work should not be presented as future planned research without clear explanation.
+
+3. Technical soundness and methodological rigor
+
+The protocol includes substantial methodological description, but important weaknesses reduce confidence in its technical robustness.
+
+Key concerns:
+
+* insufficient detail regarding analytic decision-making;
+
+* unclear outcome definitions;
+
+* limited explanation of data integration procedures;
+
+* absence of clear distinction between confirmatory and exploratory analyses;
+
+* inadequate justification for some design choices.
+
+The protocol appears conceptually ambitious but methodologically uneven.
+
+Section-specific comments
+
+4. Sub-study 1: Secondary quantitative analysis
+
+This component raises several concerns.
+
+First, because this study is already described as completed and published, it should not be framed as prospective protocol work.
+
+Second, the statistical analysis plan lacks sufficient rigor. The manuscript proposes descriptive analyses and proportion comparisons , but the dataset spans more than a decade, suggesting the need for stronger trend analysis methods.
+
+Third, key methodological details are missing:
+
+* precise variable definitions;
+
+* unit of analysis;
+
+* treatment of missing data;
+
+* reconciliation between DHAMIS programme data and Spectrum estimates;
+
+* assumptions underlying denominator construction.
+
+Without these details, reproducibility is limited.
+
+5. Sub-study 2: Scoping review
+
+The scoping review methodology is broadly structured but contains methodological inconsistencies.
+
+Concerns include:
+
+* mixing multiple frameworks (Arksey & O’Malley, Levac, JBI, PRISMA-P, PRISMA-ScR) without clear methodological coherence;
+
+* inappropriate inclusion of formal risk-of-bias tools, which is not standard for scoping reviews unless explicitly justified;
+
+* inconsistency between PCC and PICO frameworks;
+
+* mismatch between stated target population (children 0–14 years) and inclusion of adolescents in search terms;
+
+* unsupported dismissal of language bias resulting from English-only inclusion.
+
+This component requires methodological tightening.
+
+6. Sub-study 3: Modified e-Delphi process
+
+The Delphi methodology requires greater precision.
+
+Specific concerns:
+
+* unclear expert eligibility criteria;
+
+* reliance on professional networks, creating potential selection bias;
+
+* ambiguous consensus definitions;
+
+* no clearly defined stopping rule for Delphi rounds;
+
+* insufficient detail on questionnaire development and piloting;
+
+* risk that the planned in-person workshop compromises Delphi anonymity and independence.
+
+These methodological details should be clarified to improve rigor and reproducibility.
+
+7. Sub-study 4: Feasibility and acceptability assessment
+
+This is the weakest methodological component.
+
+The proposed design assesses participant perceptions after watching a short video illustrating interventions rather than assessing interventions under real implementation conditions .
+
+This raises major validity concerns.
+
+Watching a simulated intervention does not constitute genuine feasibility testing. Participants cannot reliably assess:
+
+* operational feasibility,
+
+* implementation burden,
+
+* workflow integration,
+
+* sustainability,
+
+* staffing implications.
+
+At best, this design assesses perceived acceptability, appropriateness, or hypothetical feasibility.
+
+Additional concerns:
+
+* unclear mixed-methods integration;
+
+* weak sample size justification;
+
+* single-site design without adequate justification;
+
+* high risk of social desirability bias;
+
+* principal investigator serving as sole data collector, increasing bias risk.
+
+This component requires substantial redesign or clearer reframing.
+
+8. Replicability and methodological transparency
+
+The manuscript provides moderate methodological detail, but reproducibility remains limited.
+
+Missing or insufficiently described elements include:
+
+* sample size calculations or power analysis for quantitative work;
+
+* justification for participant numbers in Delphi and feasibility studies;
+
+* instrument validation procedures;
+
+* data handling procedures;
+
+* bias mitigation strategies;
+
+* integration methods for mixed-methods findings.
+
+More methodological precision is needed for another researcher to replicate the work.
+
+9. Data availability
+
+The manuscript does not adequately meet PLOS ONE data-sharing expectations.
+
+Although this is a protocol manuscript, the authors should clearly specify how data generated from the study will be shared upon completion.
+
+Current concerns:
+
+* no named public repository;
+
+* no description of what datasets will be shared;
+
+* no clarification of access restrictions for national programme data;
+
+* no plan for sharing de-identified qualitative data.
+
+A PLOS-compliant data availability statement is required.
+
+10. Ethics
+
+Ethics reporting is inconsistent.
+
+The manuscript states ethical approval “will be obtained,” while submission metadata suggests approval already exists.
+
+Additional concerns:
+
+* ambiguity regarding secondary data ethics approval versus exemption;
+
+* confidentiality risks associated with recruitment through HIV clinic settings;
+
+* no explicit governance for use of participant actors in intervention videos.
+
+These issues should be clarified.
+
+11. Language, presentation, and clarity
+
+The manuscript is generally understandable, but substantial editing is required before publication consideration.
+
+Concerns:
+
+* grammatical and typographical errors;
+
+* awkward sentence construction;
+
+* excessive repetition;
+
+* inconsistent terminology;
+
+* formatting inconsistencies;
+
+The manuscript would benefit from thorough language editing.
+
+Minor comments
+
+* Define DHAMIS at first use.
+
+* Clarify whether adolescents are included.
+
+* Justify selection of Kabudula Community Hospital.
+
+* Clarify whether adapted AIM/IAM/FIM tools retain validation properties.
+
+* Standardize terminology throughout.
+
+* Improve formatting consistency.
+
+* Remove speculative findings language from protocol sections.
+
+* Strengthen limitations discussion.
+
+* Provide clearer summary workflow figure.
+
+Reviewer #2: the protocal is sound, has clear rationale, multi method design combining secondary data review and literature review, is aligned with global target, has mentioned clear approval, consent and confidentality demonstrated. Its based on Malawi with a possibility of it being scaled. However theres need to condence the abtract, could also mention the exixting strategies which have failed if any. For methods study 1but justification for choice of tests (chi-square vs Fisher’s exact) could be clearer.Sub-study 2: Scoping review lacks detail on inclusion/exclusion criteria, databases, and search strategy.Sub-study 3: The modified e-Delphi process is appropriate, but criteria for expert selection should be specified.Sub-study 4: Feasibility assessment mentions video demonstration and questionnaires, but lacks detail on sample size, recruitment, and analytic approach
+
+data availability written as N/A since its a protocal but may give a statement on how data will be shared
+
+Reviewer #3: Dear Author,
+
+The research question is relevant, and you clearly described the current disparities and how the pediatric population is impacted. I have a few comments.
+
+1. For Aim 1, in line 197, what informed the decision to disaggregate data into 15 and below and above 15 years old? Does adult age begin at 15? I'd recommend using WHO standardized ages and age boundaries that are less wide for a more granular comparison.
+
+2. In line 203, why is the study team using both SPSS and Stata? I'd recommend sticking with one tool to ease collaboration among the analysts within the team.
+
+3. In line 214, about statistical significance at the 5% level, while I understand what you mean, it should be clear that the confidence level is 95% and that the decision to accept the null hypothesis or alternate hypothesis is based on the alpha value of 0.05.
+
+4. Similar to aim 1, the reviewers might find it difficult to include age-appropriate studies in the scoping review. WHO currently uses 19 years as a threshold and has ranges that you could find more informative to describe the terms "neonate," "child," and "adolescent" more clearly for the reviewers.
+
+5. Aim 2 was clear, but I believe you could emphasize that the panel of experts will validate the findings from Aim 2. Recent scoping review protocols usually add a validation step, which I think is useful. The Delphi approach also achieves a similar validation intent.
+
+Looking forward to reading the revised edition.
+
+**********
+
+what does this mean?). If published, this will include your full peer review and any attached files.
+
+If you choose “no”, your identity will remain anonymous but your review may still be made public.
+
+Do you want your identity to be public for this peer review?  For information about this choice, including consent withdrawal, please see our Privacy Policy
+
+Reviewer #1: No
+
+Reviewer #2: No
+
+Reviewer #3: Yes:  Adebowale Sylvester Adeyemi
+
+**********
+
+[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]
+
+To ensure your figures meet our technical requirements, please review our figure guidelines: https://journals.plos.org/plosone/s/figures
+
+You may also use PLOS’s free figure tool, NAAS, to help you prepare publication quality figures: https://journals.plos.org/plosone/s/figures#loc-tools-for-figure-preparation.
+
+NAAS will assess whether your figures meet our technical requirements by comparing each figure against our figure specifications.
+
+DOI: 10.1371/journal.pone.0357408.r003
+
+Author response to Decision Letter 1
+
+Submission Version: 1
+
+16 Jul 2026
+
+Dear Editor,
+
+On behalf of my co-authors, I am pleased to submit the revised version of our manuscript entitled " Investigating strategies to enhance access to HIV services among children in Malawi: A multifaceted research approach, study protocol " for further consideration for publication in PLOS ONE.
+
+We thank you and the reviewers for the thorough and constructive evaluation of our manuscript. We greatly appreciate the insightful comments, which have substantially strengthened the scientific rigor, methodological transparency, and overall clarity of the protocol. We have carefully considered every comment raised by the reviewers and have revised the manuscript accordingly. A detailed point-by-point response to all reviewer comments accompanies this submission.
+
+The major revisions undertaken include, but are not limited to, the following:
+
+• The study rationale and research question have been refined by clearly defining the concepts of "access to HIV services" and "approaches," strengthening the justification for the evidence gap, and articulating the conceptual linkage between the four sub-studies through a sequential mixed-methods framework supported by a workflow figure.
+
+• The manuscript has been revised to clearly distinguish completed work from prospective study components, thereby resolving ambiguities regarding the protocol status.
+
+• Methodological rigor has been strengthened across all study components through expanded descriptions of study variables, outcome definitions, statistical analyses, data integration procedures, sampling strategies, instrument development, consensus criteria, and bias mitigation measures.
+
+• The scoping review methodology has been aligned with current Joanna Briggs Institute guidance and the PRISMA Extension for Scoping Reviews (PRISMA-ScR), with consistent application of the Population–Concept–Context framework and clarification of eligibility criteria and search strategy.
+
+• The modified Delphi methodology has been expanded to include explicit expert eligibility criteria, consensus definitions, stopping rules, questionnaire development procedures, and clarification of the role of the post-Delphi stakeholder workshop.
+
+• The feasibility component has been reframed to evaluate anticipated feasibility, acceptability, and appropriateness rather than real-world implementation feasibility, with additional detail provided regarding sampling, recruitment, mixed-methods analysis, and study limitations.
+
+• Additional information has been incorporated regarding data management, ethical considerations, methodological transparency, and study limitations to improve reproducibility and compliance with reporting standards.
+
+• The manuscript has undergone comprehensive language editing to improve clarity, consistency, grammar, terminology, and formatting throughout.
+
+In response to the journal's editorial requirements, we also wish to clarify the following:
+
+1. PLOS ONE formatting requirements
+
+We confirm that the manuscript has been revised to comply with the PLOS ONE formatting guidelines, including formatting of the title page, manuscript structure, headings, tables, figures, references, and file naming conventions in accordance with the journal's style templates.
+
+2. Competing Interests
+
+The authors declare that no competing interests exist.
+
+3. Data Availability Statement
+
+As this manuscript describes a study protocol, no datasets have yet been generated or analysed.
+
+The revised manuscript now includes the following Data Availability Statement:
+
+"As this manuscript describes a study protocol, no datasets have yet been generated or analysed. Upon completion of the study, de-identified quantitative datasets supporting the published findings will be deposited in an appropriate public data repository where permitted by national data-sharing agreements. Qualitative data will be shared in a de-identified form upon reasonable request, subject to ethical approval, participant confidentiality, and Malawi Ministry of Health data governance requirements. Secondary national programme data used in this study remain subject to Ministry of Health data access policies and cannot be shared by the authors without permission from the data custodian."
+
+4. Ethics Statement
+
+We confirm that the ethics statement now appears only within the Methods section of the manuscript, in accordance with PLOS ONE requirements, and has been removed from all other sections.
+
+5. Reviewer-recommended references
+
+We carefully evaluated all publications suggested by the reviewers. Relevant methodological and substantive references have been incorporated where appropriate to strengthen the scientific justification and reporting of the study. References that were not directly relevant to the study objectives or methodology were not included.
+
+We believe that the revisions have substantially strengthened the manuscript and have addressed all concerns raised by both the reviewers and the editorial office. We hope that the revised manuscript is now suitable for publication in PLOS ONE.
+
+Thank you for your time and consideration. We look forward to your favourable response.
+
+Attachment Submitted filename: Response_to_reviewers.docx
+
+DOI: 10.1371/journal.pone.0357408.r004
+
+Decision Letter 1
+
+Buh Amos Academic Editor
+Copyright: © 2026 Amos Buh
+Copyright year: 2026
+Copyright holder: Amos Buh
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Submission Version: 1
+
+17 Aug 2026
+
+Investigating strategies to enhance access to HIV services among children in Malawi: a multifaceted research approach, study protocol
+
+PONE-D-26-13065R1
+
+Dear Dr. Matola,
+
+We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.
+
+Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.
+
+An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact billing support.
+
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+
+Kind regards,
+
+Amos Buh, BSc., MPH, PhD
+
+Academic Editor
+
+PLOS One
+
+Additional Editor Comments (optional):
+
+Reviewers' comments:
+
+Reviewer's Responses to Questions
+
+Comments to the Author
+
+1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+4. Have the authors described where all data underlying the findings will be made available when the study is complete??>
+
+The PLOS Data policy
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+5. Is the manuscript presented in an intelligible fashion and written in standard English??>
+
+Reviewer #2: Yes
+
+Reviewer #3: Yes
+
+**********
+
+Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.
+
+You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.
+
+Reviewer #2: As a study protocol, the multi-methodological approach is clearly aligned with the core research question. The descriptive and comparative statistics planned are appropriate and well-defined and Ethical approval sources are detailed, and data governance policies are appropriately stated.
+
+Reviewer #3: It was great reading through the document once again. The revised copy adequately addressed my previous concerns.
+
+**********
+
+what does this mean?). If published, this will include your full peer review and any attached files.
+
+If you choose “no”, your identity will remain anonymous but your review may still be made public.
+
+Do you want your identity to be public for this peer review?  For information about this choice, including consent withdrawal, please see our Privacy Policy
+
+Reviewer #2: No
+
+Reviewer #3: Yes:  Adebowale Sylvester Adeyemi
+
+**********
+
+DOI: 10.1371/journal.pone.0357408.r005
+
+Acceptance letter
+
+Buh Amos Academic Editor
+Copyright: © 2026 Amos Buh
+Copyright year: 2026
+Copyright holder: Amos Buh
+License: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+PONE-D-26-13065R1
+
+PLOS One
+
+Dear Dr. Matola,
+
+I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS One. Congratulations! Your manuscript is now being handed over to our production team.
+
+At this stage, our production department will prepare your paper for publication. This includes ensuring the following:
+
+* All references, tables, and figures are properly cited
+
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+
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+
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+
+Kind regards,
+
+PLOS One Editorial Office Staff
+
+on behalf of
+
+Dr. Amos Buh
+
+Academic Editor
+
+PLOS One
+
+
+References
+
+1 Unaids. Fact sheet 2024 - Latest global and regional HIV statistics on the status of the AIDS epidemic. 2024.
+2 Parker E , Judge MA , Macete E , Nhampossa T , Dorward J , Langa DC , et al. HIV infection in Eastern and Southern Africa: Highest burden, largest challenges, greatest potential. South Afr J HIV Med. 2021;22(1):1237. doi: 10.4102/sajhivmed.v22i1.1237 34192070 PMC8182467
+3 Malawi 2025 HIV estimates_Care-Treatment-TWG. 2025.
+4 Fast-track targets. 2020.
+5 National strategic plan for HIV and AIDS 2020-25 final.
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+7 Chakakala-Chaziya J , Patson N , Samuel V , Mbotwa J , Buonsenso D , Chisale M , et al. A comparison of clinical outcomes among people living with HIV of different age groups attending queen Elizabeth central hospital outpatient ART Clinic in Malawi. Front Med (Lausanne). 2023;10:1175553. doi: 10.3389/fmed.2023.1175553 37795414 PMC10546013
+8 Tsiouris F , Alons C , Maurice M , Bhatt N , Rakhmanina N , Gill MM , et al. Reimagining Paediatric HIV Care: Centering Infants and Young Children in Optimized, Integrated Models of Care. J Int AIDS Soc. 2026;29 Suppl 1(Suppl 1):e70103. doi: 10.1002/jia2.70103 42319210 PMC13281406
+9 WHO recommendations on the diagnosis of HIV infection in infants and children. World Health Organization; 2010. pp. 55.23741779
+10 Dzinamarira T , Moyo E . Adolescents and young people in sub-Saharan Africa: overcoming challenges and seizing opportunities to achieve HIV epidemic control. Front Public Health. 2024;12:1321068. doi: 10.3389/fpubh.2024.1321068 38566795 PMC10985137
+11 Nyasulu JCY , Maposa I , Sikhakhane BP , Pandya H . Access to HIV services and viral load suppression among children during the 90-90-90 strategy implementation in South Africa: a time series analysis. South Afr J HIV Med. 2021;22(1). doi: 10.4102/SAJHIVMED.V22I1.1187 PMC8008010 33824733
+12 Tao Y , Xiao X , Zhang C , Xie Y , Wang H . Prevalence of delayed antiretroviral therapy initiation among people living with HIV: a systematic review and meta-analysis. PLoS One. 2023;18(10):e0286476. doi: 10.1371/journal.pone.0286476 37874794 PMC10597480
+13 Kamau SG , Akatusasira R , Namatovu A , Kibet E , Ssekitto JM , Mamun MA , et al. The level of antiretroviral therapy (ART) adherence among orphan children and adolescents living with HIV/AIDS: A systematic review and meta-analysis. PLoS One. 2024;19(2):e0295227. doi: 10.1371/journal.pone.0295227 38381726 PMC10881004
+14 Carter A , Walters MK , Jahagirdar D , Brewer ED , Novotney A , Lasher D , et al. Global, regional, and national burden of HIV/AIDS, 1990–2021, and forecasts to 2050, for 204 countries and territories: the Global Burden of Disease Study 2021. Lancet HIV. 2024;11(12):e807–22. doi: 10.1016/S2352-3018(24)00212-1 39608393 PMC11612058
+15 Iyun V , Technau KG , Vinikoor M , Yotebieng M , Vreeman R , Abuogi L , et al. Variations in the characteristics and outcomes of children living with HIV following universal ART in sub-Saharan Africa (2006–17): a retrospective cohort study. Lancet HIV. 2021;8(6):e353–62. doi: 10.1016/S2352-3018(21)00004-7 33932330 PMC8178242
+16 Haw NJL , Banegas M , Lujintanon S , Fairlie L , Bwakura-Dangarembizi M , Agwu A , et al. Characterizing the HIV care continuum among children and adolescents with HIV in eastern and southern Africa in the era of “Universal Test and Treat”: A systematic review and meta-analysis. J Int AIDS Soc. 2025;28(6):e26526. doi: 10.1002/jia2.26526 40515449 PMC12166130
+17 Li W , Koay A , Kose-Otieno J , Rakhmanina N . HIV drug resistance in children and adolescents: always a challenge? 2021. doi: 10.1007/s40471-021-00268-3 PMC7971393 33758743
+18 Malawi National Strategic Plan for HIV and AIDS Revised and Extended Strategy for 2023-2027 Sustaining Gains and Accelerating Progress Towards Elimination.
+19 Mugglin C , Haas AD , van Oosterhout JJ , Msukwa M , Tenthani L , Estill J , et al. Long-term retention on antiretroviral therapy among infants, children, adolescents and adults in Malawi: A cohort study. PLoS One. 2019;14(11):e0224837. doi: 10.1371/journal.pone.0224837 31725750 PMC6855432
+20 national-strategic-plan-for-hiv-and-aids. 2020.
+21 Malawi-HIV-Syphilis-and-Hepatitis-B-Integrated-Rapid-Testing-Guidelines. 2023.
+22 Bulstra CA , Hontelez JAC , Otto M , Stepanova A , Lamontagne E , Yakusik A . Integrating HIV services and other health services: a systematic review and metaanalysis. PLoS Med. 2021. doi: 10.1371/journal.pmed.1003836 34752477 PMC8577772
+23 Kiragu K , Collins L , Von Zinkernagel D , Mushavi A . Integrating PMTCT Into Maternal, Newborn, and Child Health and Related Services: Experiences From the Global Plan Priority Countries [Internet]. 2017. Available from: www.jaids.com 10.1097/QAI.0000000000001323 28398995
+24 Huber A , Pascoe S , Nichols B , Long L , Kuchukhidze S , Phiri B , et al. Differentiated Service Delivery Models for HIV Treatment in Malawi, South Africa, and Zambia: A Landscape Analysis Key Findings [Internet]. Available from: www.ghspjournal.org 10.9745/GHSP-D-20-00532 PMC8324204 34234023
+25 Chinguwo F , Nyondo-Mipando AL . Integration of early infant diagnosis of hiv services into village health clinics in Ntcheu, Malawi: an exploratory qualitative study. J Int Assoc Provid AIDS Care. 2021;20. doi: 10.1177/2325958220981256 33557679 PMC7876752
+26 Atun R , Silva S , Ncube M , Vassall A . Innovative financing for HIV response in sub-Saharan Africa. J Glob Health. 2016;6(1):010407. doi: 10.7189/jogh.06.010407 27231543 PMC4871060
+27 Kebede B , Gebeyehu A , Jain S , Sun S , Haubrich R . Delay in early infant diagnosis and high loss to follow-up among infant born to HIV-infected women in Ethiopia. World J AIDS. 2014;04(04):402–12. doi: 10.4236/wja.2014.44048
+28 Sindelar K , Maponga C , Lekoala F , Mandara E , Mohoanyane M , Sanders J , et al. Beyond the facility: An evaluation of seven community-based pediatric HIV testing strategies and linkage to care outcomes in a high prevalence, resource-limited setting. PLoS One. 2020;15(9):e0236985. doi: 10.1371/journal.pone.0236985 32877441 PMC7467225
+29 Palk L , Okano JT , Dullie L , Blower S . Travel time to health-care facilities, mode of transportation, and HIV elimination in Malawi: a geospatial modelling analysis. 2020. Available from: www.thelancet.com/lancetgh 10.1016/S2214-109X(20)30351-X PMC7738178 33220218
+30 Mbogela J , Kyando A , Mahenge R . The children left behind barriers to identifying and enrolling children with HIV into care and treatment programs. 2017. http://www.measureevaluation.org/tanzania
+31 Simmonds FM , Cohn JE , Mafaune HW , Nyamundaya TH , Mahomva A , Chadambuka A . Task shifting for point-of-care early infant diagnosis: a comparison of the quality of testing between nurses and laboratory personnel in Zimbabwe. Hum Resour Health. 2020;18(1):4. doi: 10.1186/s12960-020-0449-2 31992332 PMC6986104
+32 Kredo T , Adeniyi FB , Bateganya M , Pienaar ED . Task shifting from doctors to non-doctors for initiation and maintenance of antiretroviral therapy. Cochrane Database Syst Rev. 2014;2014(7):CD007331. doi: 10.1002/14651858.CD007331.pub3 24980859 PMC11214583
+33 Okoroafor SC , Christmals CD . Task shifting and task sharing implementation in Africa: A scoping review on rationale and scope. Healthcare. 2023. doi: 10.3390/healthcare11081200 PMC10138489 37108033
+34 Humphrey J , Nagel E , Carlucci JG , Edmonds A , Kinikar A , Anderson K , et al. Integration of HIV care into maternal and child health services in the global IeDEA consortium. Front Glob Womens Health. 2023;4:1066297. doi: 10.3389/fgwh.2023.1066297 37139173 PMC10150067
+35 Schmitz K , Basera TJ , Egbujie B , Mistri P , Naidoo N , Mapanga W . Impact of lay health worker programmes on the health outcomes of mother-child pairs of HIV exposed children in Africa: A scoping review. PLoS ONE. 2019. doi: 10.1371/journal.pone.0211439 30703152 PMC6355001
+36 Boeke CE , Joseph J , Wang M , Abate ZM , Atem C , Diatou Coulibaly K , et al. Point-of-care testing can achieve same-day diagnosis for infants and rapid ART initiation: results from government programmes across six African countries [Internet]. 2021. doi: 10.1002/jia2.25677/full PMC7981587 33745234
+37 Sutcliffe CG , Moyo N , Schue JL , Mutanga JN , Hamahuwa M , Munachoonga P , et al. The NSEBA Demonstration Project: implementation of a point-of-care platform for early infant diagnosis of HIV in rural Zambia. Trop Med Int Health. 2021;26(9):1036–46. doi: 10.1111/tmi.13627 33999480 PMC8416694
+38 Mamulwar M , Prasad VS , Nirmalkar A , Goli S , Jadhav S , Kumbhar S , et al. Community-based point-of-care testing to identify new HIV infections: A cross-sectional study from Pune, India. Medicine (United States). 2021;100(46):E27817. doi: 10.1097/MD.0000000000027817 34797308 PMC8601338
+39 Jani IV , Meggi B , Loquiha O , Tobaiwa O , Mudenyanga C , Zitha A , et al. Effect of point-of-care early infant diagnosis on antiretroviral therapy initiation and retention of patients. AIDS. 2018;32(11):1453–63. doi: 10.1097/QAD.0000000000001846 29746301
+40 Migamba SM , Nyombi TN , Nsubuga EJ , Kwiringira A , Delaney A , Kabwama SN , et al. Rapid antiretroviral therapy initiation following rollout of point-of-care early infant diagnosis testing, Uganda, 2018–2021. AIDS Res Ther. 2024;21(1). doi: 10.1186/s12981-024-00613-8 38750529 PMC11094911
+41 Odhiambo CO , Githuka G , Bowen N , Kingwara L , Onsase J , Ochuka B , et al. Point-of-care early infant diagnosis improves adherence to the testing algorithm in Kenya. J Int Assoc Provid AIDS Care. 2020;19. doi: 10.1177/2325958220906030 32052676 PMC7019379
+42 Arora DR , Maheshwari M , Arora B . Rapid point-of-care testing for detection of hiv and clinical monitoring. ISRN AIDS. 2013;2013:287269. doi: 10.1155/2013/287269 24052887 PMC3767371
+43 Auld AF , Nuwagaba-Biribonwoha H , Azih C , Kamiru H , Baughman AL , Agolory S , et al. Decentralizing access to antiretroviral therapy for children living with HIV in Swaziland. Pediatr Infect Dis J. 2016;35(8):886–93. doi: 10.1097/INF.0000000000001075 26849157 PMC11552438
+44 Herce ME , Chagomerana MB , Zalla LC , Carbone NB , Chi BH , Eliya MT , et al. Community-facility linkage models and maternal and infant health outcomes in Malawi’s PMTCT/ART program: A cohort study. PLoS Med. 2021;18(9):e1003780. doi: 10.1371/journal.pmed.1003780 34534213 PMC8516224
+45 Aron MB , Ndambo MK , Munyaneza F , Mulwafu M , Makungwa H , Nhlema B , et al. A time-motion study of community health workers delivering community-based primary health care in Neno District, Malawi. Hum Resour Health. 2023;21(1):51. doi: 10.1186/s12960-023-00839-z 37365561 PMC10294529
+46 Amzel A, Srivastava M, Isavwa A, Sanders J, Tumbare E, Membe I, et al. Community-based interventions to reach 95-95-95 for children and adolescents: an exploratory programmatic review from Lesotho. 2018.10.1097/QAI.0000000000001735 29994829
+47 Preidis GA , McCollum ED , Kamiyango W , Garbino A , Hosseinipour MC , Kazembe PN . Routine inpatient provider-initiated HIV testing in Malawi, compared with client-initiated community-based testing, identifies younger children at higher risk of early mortality. J Acquir Immune Defic Syndr. 2013;63(1). doi: 10.1097/QAI.0b013e318288aad6 23364511 PMC4364280
+48 Busza J , Dauya E , Bandason T , Simms V , Chikwari CD , Makamba M , et al. The role of community health workers in improving HIV treatment outcomes in children: lessons learned from the ZENITH trial in Zimbabwe. Health Policy Plan. 2018;33(3):328–34. doi: 10.1093/heapol/czx187 29309578 PMC5886269
+49 Arije O , Titus R , Olaniran A , Dadi A , Garba D , Okeke E , et al. Effectiveness of community mobilisation models in improving HIV testing services uptake among women and children in Nigeria: a quasi-experimental study. Glob Public Health. 2023;18(1):2284880. doi: 10.1080/17441692.2023.2284880 38015746
+50 Morse JM . Simultaneous and sequential qualitative mixed method designs. Qual Inquiry. 2010;16(6):483–91. doi: 10.1177/1077800410364741
+51 Slater P , Hasson F . Quantitative research designs, hierarchy of evidence and validity. J Psychiatr Ment Health Nurs. 2025;32(3):656–60. doi: 10.1111/jpm.13135 39620883 PMC12056466
+52 Stover J , Glaubius R , Mofenson L , Dugdale CM , Davies MA , Patten G , et al. Updates to the Spectrum/AIM model for estimating key HIV indicators at national and subnational levels. AIDS. 2019;33(S227–34). doi: 10.1097/QAD.0000000000002357 31805028 PMC6919230
+53 Pollock D , Evans C , Menghao Jia R , Alexander L , Pieper D , Brandão de Moraes É , et al. “How-to”: scoping review? J Clin Epidemiol. 2024;176:111572. doi: 10.1016/j.jclinepi.2024.111572 39426499
+54 Peters MDJ , Marnie C , Tricco AC , Pollock D , Munn Z , Alexander L , et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth. 2020;18(10):2119–26. doi: 10.11124/JBIES-20-00167 33038124
+55 Pollock D , Peters MDJ , Khalil H , McInerney P , Alexander L , Tricco AC , et al. Recommendations for the extraction, analysis, and presentation of results in scoping reviews. JBI Evid Synth. 2023;21(3):520–32. doi: 10.11124/JBIES-22-00123 36081365
+56 Tricco AC , Lillie E , Zarin W , O’Brien KK , Colquhoun H , Levac D , et al. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation. Ann Intern Med. 2018;169(7):467–73. doi: 10.7326/M18-0850 30178033
+57 Ouzzani M , Hammady H , Fedorowicz Z , Elmagarmid A . Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210. doi: 10.1186/s13643-016-0384-4 27919275 PMC5139140
+58 Belton I , MacDonald A , Wright G , Hamlin I . Improving the practical application of the Delphi method in group-based judgment: A six-step prescription for a well-founded and defensible process. Technological Forecasting and Social Change. Elsevier Inc.; 2019. pp. 72–82. doi: 10.1016/j.techfore.2019.07.002
+59 Palinkas LA , Horwitz SM , Green CA , Wisdom JP , Duan N , Hoagwood K . Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533–44. doi: 10.1007/s10488-013-0528-y 24193818 PMC4012002
+60 Manyara AM , Purvis A , Ciani O , Collins GS , Taylor RS . Sample size in multistakeholder Delphi surveys: at what minimum sample size do replicability of results stabilize? J Clin Epidemiol. 2024;174:111485. doi: 10.1016/j.jclinepi.2024.111485 39069013 PMC7617918
+61 Jünger S , Payne SA , Brine J , Radbruch L , Brearley SG . Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017;31(8):684–706. doi: 10.1177/0269216317690685 28190381
+62 Weiner BJ , Lewis CC , Stanick C , Powell BJ , Dorsey CN , Clary AS , et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):108. doi: 10.1186/s13012-017-0635-3 28851459 PMC5576104
+63 Hennink M , Kaiser BN . Sample sizes for saturation in qualitative research: a systematic review of empirical tests. Soc Sci Med. 2022;292:114523. doi: 10.1016/j.socscimed.2021.114523 34785096
+64 Tavakol M , Dennick R . Making sense of Cronbach’s alpha. Int J Med Educ. 2011;2:53–5. doi: 10.5116/ijme.4dfb.8dfd 28029643 PMC4205511
+65 Kilanowski JF . Breadth of the socio-ecological model. J Agromed. 2017;22(4):295–7. doi: 10.1080/1059924X.2017.1358971 28742433
+66 Xue D , Ye Y , Chen Z , Hu Y , Yuan C , Wang Y . Effects of peer support interventions for family caregivers of persons with dementia: a systematic review and meta-analysis. Arch Gerontol Geriatr. 2026;144:106168. doi: 10.1016/j.archger.2026.106168 41690252
+67 Al-Turbag M , Mooney M , Corry M . A systematic review and meta-analysis of appointment reminders for enhancing hospital attendance. J Hosp Manag Health Policy. 2026;10:2–2. doi: 10.21037/jhmhp-25-51
+68 Gao X , Wu Y , Zhang Y , Zhang N , Tang J , Qiu J , et al. Effectiveness of school-based education on HIV/AIDS knowledge, attitude, and behavior among secondary school students in Wuhan, China. PLoS One. 2012;7(9):e44881. doi: 10.1371/journal.pone.0044881 22970322 PMC3436789
+69 Carries S , Mkhwanazi Z , Sithole N , Sigwadhi L , Moshabela M , Nyirenda M , et al. Using a cash transfer plus SMS nudge package to improve the wellbeing among caregivers of adolescents living with HIV during the COVID-19 epidemic in South Africa: a pilot randomised controlled trial. PLOS Glob Public Health. 2025;5(5):e0003799. doi: 10.1371/journal.pgph.0003799 40378145 PMC12083824
+70 Han H-R , Kim K , Murphy J , Cudjoe J , Wilson P , Sharps P , et al. Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review. PLoS One. 2018;13(4):e0194928. doi: 10.1371/journal.pone.0194928 29689054 PMC5915269
+71 Bateganya M , Abdulwadud OA , Kiene SM . Home-based HIV voluntary counselling and testing (VCT) for improving uptake of HIV testing. Cochrane Database Syst Rev. 2010;2010(7):CD006493. doi: 10.1002/14651858.CD006493.pub4 20614446 PMC6464814
+72 Elsbernd K , Sabi I , Jani IV , Mudenyanga C , Boniface S , Mahumane A . Point-of-care early infant HIV diagnosis at birth in a pragmatic cluster-randomized trial in Mozambique and Tanzania: a comparative cost and cost-effectiveness study. PLoS Med. 2026;23(5). doi: 10.1371/journal.pmed.1005069 42090430 PMC13166934
+73 Simon KR , Flick RJ , Kim MH , Sabelli RA , Tembo T , Phelps BR , et al. Family testing: an index case finding strategy to close the gaps in pediatric HIV diagnosis. J Acquir Immune Defic Syndr. 2018;78 Suppl 2(Suppl 2):S88–97. doi: 10.1097/QAI.0000000000001731 29994830 PMC6047763
+74 Akinleye O , Dura G , de Wagt A , Davies A , Chamla D . Integration of HIV testing into maternal, newborn, and child health weeks for improved case finding and linkage to prevention of mother-to-child transmission services in Benue State, Nigeria. Front Public Health. 2017;5:71. doi: 10.3389/fpubh.2017.00071 28443275 PMC5385441
+75 Lindegren ML , Kennedy CE , Bain-Brickley D , Azman H , Creanga AA , Butler LM , et al. Integration of HIV/AIDS services with maternal, neonatal and child health, nutrition, and family planning services. Cochrane Database Syst Rev. 2012;2012(9):CD010119. doi: 10.1002/14651858.CD010119 22972150 PMC12551653
+76 Limbani F , Thorogood M , Gómez-Olivé FX , Kabudula C , Goudge J . Task shifting to improve the provision of integrated chronic care: realist evaluation of a lay health worker intervention in rural South Africa. BMJ Global Health. 2019;4(1). doi: 10.1136/bmjgh-2018-001084 PMC6352781 30775003
diff --git a/corpus/healthcare/text/df6169bd852f0cf2.txt b/corpus/healthcare/text/df6169bd852f0cf2.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Sci Rep
+Journal ID: Sci Rep
+NLM Journal ID: 101563288
+
+Scientific Reports
+
+EISSN: 2045-2322
+Publisher: Nature Publishing Group
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13294333
+PMID: 42342759
+DOI: 10.1038/s41598-026-57081-5
+Article ID: 57081
+Article version: 1
+Subjects: Correction
+
+Correction: Assessing the risk of bias of clinical trials with large language models and ROBUST-RCT: a feasibility study
+
+http://orcid.org/0000-0001-9208-7323 Vidor Pedro Rodrigues pedro.vidor@ufrgs.br
+1
+http://orcid.org/0000-0003-4762-4569 Casiraghi Yohan 1
+http://orcid.org/0000-0002-0786-5571 de Souza Adolfo Moraes 1
+http://orcid.org/0000-0002-3837-0731 Schmidt Maria Inês 1 2
+1 https://ror.org/041yk2d64 grid.8532.c 0000 0001 2200 7498 School of Medicine, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, R. Ramiro Barcelos, 2400, Porto Alegre (RS), Porto Alegre, 90035-003 Brazil
+2 https://ror.org/041yk2d64 grid.8532.c 0000 0001 2200 7498 Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil
+Electronic publication date: 2026 Jun 24
+Publication date: 2026
+Volume: 16
+Electronic Location ID: 19571
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Assessing the risk of bias of clinical trials with large language models and ROBUST-RCT: a feasibility study 16 17 3 2026 13723 Scientific Reports 10.1038/s41598-026-44303-z PMC13125330 41844753
+issue-copyright-statement: © Springer Nature Limited 2026
+
+Ÿ==============================Ÿ
+Correction to: Scientific Reports 10.1038/s41598-026-44303-z, published online 17 March 2026
+
+The original version of this Article contained an error in the Abstract.
+
+“A sample of 56 assessments, derived from 9 studies, was compared for each LLM against human consensus.”
+
+now reads:
+
+“A sample of 54 assessments, derived from 9 studies, was compared for each LLM against human consensus.”
+
+The original Article has been corrected.
+
diff --git a/corpus/healthcare/text/df774b5cf3b7fe13.txt b/corpus/healthcare/text/df774b5cf3b7fe13.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Cardiovasc Dev Dis
+Journal ID: J Cardiovasc Dev Dis
+NLM Journal ID: 101651414
+Journal ID: jcdd
+
+Journal of Cardiovascular Development and Disease
+
+EISSN: 2308-3425
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13026918
+PMID: 41892737
+DOI: 10.3390/jcdd13030125
+Article ID: jcdd-13-00125
+Article version: 1
+Subjects: Correction
+
+Correction: Cicek et al. A New Risk Prediction Model for the Assessment of Myocardial Injury in Elderly Patients Undergoing Non-Elective Surgery. J. Cardiovasc. Dev. Dis. 2025, 12, 6
+
+Cicek Vedat 1 *
+https://orcid.org/0000-0003-4544-9584 Babaoglu Mert 2
+https://orcid.org/0000-0003-3165-6769 Saylik Faysal 3
+https://orcid.org/0000-0002-1913-3001 Yavuz Samet 2
+https://orcid.org/0000-0001-5203-4681 Mazlum Ahmet Furkan 4
+https://orcid.org/0000-0001-7120-5191 Genc Mahmut Salih 4
+https://orcid.org/0000-0002-7079-4948 Altinisik Hatice 2
+https://orcid.org/0000-0002-5165-1212 Oguz Mustafa 2
+https://orcid.org/0000-0001-6488-988X Korucu Berke Cenktug 5
+Hayiroglu Mert Ilker 6
+https://orcid.org/0000-0001-8188-5020 Cinar Tufan 7
+Bagci Ulas 1
+1 Machine & Hybrid Intelligence Lab, Department of Radiology, Northwestern University, Chicago, IL 60611, USA; ulasbagci@gmail.com
+2 Sultan II. Abdulhamid Han Training and Research Hospital, Department of Cardiology, Health Sciences University, 34668 Istanbul, Turkey; babaoglumert11@gmail.com (M.B.); dr.sametyavuz@gmail.com (S.Y.); hatice.altinisik98@gmail.com (H.A.); drmustafaoguz@hotmail.com (M.O.)
+3 Van Training and Research Hospital, Department of Cardiology, Health Sciences University, 65300 Van, Turkey; faysalsaylik@gmail.com
+4 Sultan II. Abdülhamid Han Training and Research Hospital, Department of General Surgery, Health Sciences University, 34668 Istanbul, Turkey; a.furkan.mazlum@gmail.com (A.F.M.); mslhgenc@gmail.com (M.S.G.)
+5 Department of Internal Medicine, Rutgers\Robert Wood Johnson Barnabas Health, Jersey City Medical Center, Jersey City, NJ 07302, USA; cenkorucu@gmail.com
+6 Department of Cardiology, Dr. Siyami Ersek Cardiovascular and Thoracic Surgery Research and Training Hospital, 34668 Istanbul, Turkey; mertilkerh@gmail.com
+7 School of Medicine, University of Maryland, Baltimore, MD 21201, USA; drtufancinar@gmail.com
+* Correspondence: vedat.cicek@northwestern.edu; Tel.: +1-(312)478-6826
+Electronic publication date: 2026 Mar 9
+Publication date: 2026 Mar
+Volume: 13
+Issue: 3
+Electronic Location ID: 125
+Received 2026 Feb 12; Accepted 2026 Feb 25
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: A New Risk Prediction Model for the Assessment of Myocardial Injury in Elderly Patients Undergoing Non-Elective Surgery 12 1 26 12 2024 6 Journal of Cardiovascular Development and Disease 10.3390/jcdd12010006 PMC11765956 39852284
+
+Ÿ==============================Ÿ
+In the original publication [1], there was a mistake in “Figure 2” when published. “Figure was replaced by mistake during the proofreading process”. The corrected “Figure 2” appears below. The authors state that the scientific conclusions are unaffected. This correction was approved by the Academic Editor. The original publication has also been updated.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+Reference
+
+1. Cicek V. Babaoglu M. Saylik F. Yavuz S. Mazlum A.F. Genc M.S. Altinisik H. Oguz M. Korucu B.C. Hayiroglu M.I. A New Risk Prediction Model for the Assessment of Myocardial Injury in Elderly Patients Undergoing Non-Elective Surgery J. Cardiovasc. Dev. Dis. 2025 12 6 10.3390/jcdd12010006 39852284 PMC11765956
diff --git a/corpus/healthcare/text/dffb6f856d4fa958.txt b/corpus/healthcare/text/dffb6f856d4fa958.txt
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@@ -0,0 +1,73 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Psychol
+Journal ID: Front Psychol
+NLM Journal ID: 101550902
+Journal ID: Front. Psychol.
+
+Frontiers in Psychology
+
+EISSN: 1664-1078
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13101653
+PMID: 42027271
+DOI: 10.3389/fpsyg.2026.1823085
+Article version: 1
+Article version:
+Subjects: Correction
+
+Correction: Real-world evidence for clergy well-being: developing a culturally grounded self-screening tool to promote sustainable mental health outcomes
+
+Li Wen-Cheng 1
+Chin Yu-Ting 1
+Wu Li-Hsin 2
+Ling I-Ling 3 *
+Lee Chien-Hung 1 4 5 *
+1 Department of Public Health, College of Health Sciences, Kaohsiung Medical University , Kaohsiung , Taiwan
+2 Department of Psychology, University of Toronto , Toronto , ON , Canada
+3 Department of Marketing & Tourism Management, National Chiayi University , Chiayi , Taiwan
+4 Research Center for Precision Environmental Medicine, Kaohsiung Medical University , Kaohsiung , Taiwan
+5 Department of Medical Research, Kaohsiung Medical University Hospital, Kaohsiung Medical University , Kaohsiung , Taiwan
+* Correspondence: I-Ling Ling, yiling@mail.ncyu.edu.tw; Chien-Hung Lee, cnhung@kmu.edu.tw
+Electronic publication date: 2026 Apr 8
+Publication date: 2026
+Volume: 17
+Electronic Location ID: 1823085
+Received 2026 Mar 4; Accepted 2026 Mar 5
+Copyright: Copyright © 2026 Li, Chin, Wu, Ling and Lee.
+Copyright year: 2026
+Copyright holder: Li, Chin, Wu, Ling and Lee
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Real-world evidence for clergy well-being: developing a culturally grounded self-screening tool to promote sustainable mental health outcomes 17 3 3 2026 1677071 Frontiers in Psychology 10.3389/fpsyg.2026.1677071 PMC12991992 41853815
+Keywords: Chinese clergy, clergy well-being, psychological well-being, scale development, spiritual well-being, subjective well-being, work-related psychological health
+Figure count: 0
+Table count: 0
+Equation count: 0
+Reference count: 0
+Page count: 1
+
+section-at-acceptance: Cultural Psychology
+
+Ÿ==============================Ÿ
+Affiliation “Department of Public Health, College of Health Sciences, Kaohsiung Medical University, Kaohsiung, Taiwan” was omitted for author Yu-Ting Chin. This affiliation has now been added for author Yu-Ting Chin.
+
+Author Yu-Ting Chin was erroneously assigned to affiliation “Department of Marketing & Tourism Management, National Chiayi University, Chiayi, Taiwan.” This affiliation has now been removed for author Yu-Ting Chin.
+
+A correction has been made to Section “4.2.4 Criterion-related and incremental validities”:
+
+“fatigue (ΔR2 = 0.397, p < 0.01), and burnout (ΔR2 = 0.290, p < 0.01); fatigue (ΔR2 = 0.023, p < 0.01); engagement (ΔR2 = 0.018, p < 0.01); stability (ΔR2 = 0.018, p < 0.01).”
+
+The original version of this article has been updated.
+
+Publisher's note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Approved by: Frontiers Editorial Office, Frontiers Media SA, Switzerland
+
diff --git a/corpus/healthcare/text/e1b5e8177fd4fc1c.txt b/corpus/healthcare/text/e1b5e8177fd4fc1c.txt
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@@ -0,0 +1,638 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Gerodontology
+Journal ID: Gerodontology
+NLM Journal ID: 8215850
+Journal ID: GER
+
+Gerodontology
+
+ISSN: 0734-0664
+EISSN: 1741-2358
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13498931
+PMID: 42136528
+DOI: 10.1111/ger.70079
+Article ID: GER70079
+Article ID: 6492353
+Article version: 1
+Subjects: Invited Review; SPECIAL ISSUE: Staging and Grading in Gerodontology; GUEST EDITORS: Gerry McKenna, Murali Srinivasan, Falk Schwendicke, and Frauke Müller; Invited Review
+
+Association of Socioeconomic Factors With Oral Health in Older Adults: A Systematic Review and Meta‐Analysis
+
+Syed Saif S. https://orcid.org/0000-0003-1971-3003 1 2
+Pojmonpiti Sungkrit https://orcid.org/0000-0002-2255-2178 3 4 5
+Janssens Barbara https://orcid.org/0000-0003-3490-0114 3 6
+Srinivasan Murali https://orcid.org/0000-0003-3365-576X 7 8
+Müller Frauke https://orcid.org/0000-0003-3981-0134 8 9
+Tsakos Georgios https://orcid.org/0000-0002-5086-235X 1 g.tsakos@ucl.ac.uk
+
+1 Department of Epidemiology and Public Health University College London London UK
+2 Institute of Dentistry Queen Mary University of London London UK
+3 ELOHA (Equal Lifelong Oral Health for All) Research Group, Department of Oral Health Sciences, Faculty of Medicine and Health Sciences University of Ghent Ghent Belgium
+4 Department of Neurology Ghent University Hospital Ghent Belgium
+5 Dental Department, Chulabhorn Hospital Chulabhorn Royal Academy Bangkok Thailand
+6 Department of Oral Health Ghent University Hospital Ghent Belgium
+7 Clinic of General, Special Care, and Geriatric Dentistry, Center for Dental Medicine University of Zurich Zurich Switzerland
+8 Center of Excellence in Genomics and Precision Dentistry, International Program in Geriatric Dentistry and Special Care, Faculty of Dentistry Chulalongkorn University Bangkok Thailand
+9 Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine University of Geneva Geneva Switzerland
+* Correspondence:
+Georgios Tsakos (g.tsakos@ucl.ac.uk)
+
+Electronic publication date: 2026 May 15
+Print publication date: 2026 Sep
+Volume: 43
+Issue: 3
+First page: 456
+Last page: 474
+Revised 2026 Mar 4; Received 2025 Dec 24; Accepted 2026 Mar 26
+Copyright: © 2026 The Author(s). Gerodontology published by Gerodontology Association and John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: geriatric dentistry, meta‐analysis, oral health, socioeconomic factors, systematic review
+Figure count: 4
+Table count: 2
+Page count: 19
+
+source-schema-version-number: 2.0
+cover-date: September 2026
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.8.6 mode:remove_FC converted:22.08.2026
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Background
+
+Oral diseases remain disproportionately prevalent among older adults. However, evidence on oral health inequalities among older adults remains dispersed across studies that have used different socioeconomic indicators and oral health measures and has not been synthesised.
+
+Objective
+
+To synthesise the evidence on the association between socioeconomic factors and oral health among older adults aged 75 years and older.
+
+Methods
+
+A systematic review and meta‐analysis was conducted following PRISMA guidelines. The Medline, Embase, and CENTRAL databases were searched. Studies reporting socioeconomic factors (education, income, occupation, area‐level deprivation, and multi‐aspect socioeconomic position) and oral health (dentition status, dental caries, periodontal disease, dry mouth, oral function, oral health behaviours, and oral health‐related quality of life (OHRQoL)) among older adults were included. Risk of bias was assessed using the Newcastle–Ottawa Scale.
+
+Results
+
+Sixty‐eight studies were included. Meta‐analyses showed that socioeconomic disadvantage in older adults was associated with: (1) poor dentition status: fewer natural teeth, higher prevalence of edentulism, and lacking a functional dentition; (2) more teeth with decay; (3) irregular dental attendance; and (4) poorer OHRQoL. Similar patterns were generally observed for periodontal disease, dry mouth, and oral function, although no meta‐analysis could be performed due to limited evidence and heterogeneous oral health measures.
+
+Conclusion
+
+Socioeconomic disadvantage was consistently associated with poor oral health in older adults. Associations were more pronounced for dentition status, reflecting the cumulative socioeconomic disadvantage over the life course. Socioeconomic factors should be considered to inform prevention, clinical decision‐making and oral healthcare planning for the ageing population.
+
+Trial Registration
+
+PROSPERO Registration CRD420251231319
+
+1 Introduction
+
+Despite being largely preventable, oral diseases are highly prevalent, affecting over 3.7 billion people worldwide, including older adults [1]. As a result of ageing societies and changing oral epidemiology, older adults are now living longer and with heavily restored natural teeth and dental prostheses, thereby increasing the risk of oral conditions and complex treatment needs later in life [2]. Oral conditions considerably affect oral function, nutrition, and quality of life [3, 4]. Moreover, they are socially patterned, with persistent oral health inequalities documented across the life course [5, 6] and across different contexts and welfare states [7, 8], indicating the influence of social and structural health determinants.
+
+Socioeconomic factors, usually represented by a range of interrelated constructs, notably education, income and occupation, represent a key determinant of oral health over the life‐course [6, 9]. Education influences values, preventive behaviours, and self‐care, and contributes to income through improved job prospects [10]. Income and occupation affect the affordability of dental care, a healthy diet and oral hygiene products [11, 12, 13]. Occupational conditions may affect oral health through psychosocial and environmental stressors [14]. This lifelong unequal exposure to resources, risks and opportunities can lead to profound inequalities in oral health, particularly among older adults.
+
+While the influence of socioeconomic factors on oral health is well established, there is no appropriate synthesis of the strength and consistency of socioeconomic inequalities in oral health among older adults. Previous reviews have focused primarily on adults and on a single aspect of oral health, such as dental caries or periodontal disease [15, 16]. An earlier systematic review and meta‐analysis examined the influence of socioeconomic factors on multiple aspects of oral health, but not among older adults [17]. Another systematic review examined this, focusing mainly on institutionalised older adults, though not specifically on the population aged 75 years and over, and conducted a qualitative synthesis alone [18]. Moreover, oral health aspects that are particularly relevant for this age group, such as dry mouth and oral function, were not included. The relevant evidence is dispersed across studies that use different socioeconomic indicators and oral health measures, limiting generalisability and the ability to draw conclusions.
+
+To address this knowledge gap, a comprehensive systematic review and meta‐analysis of the evidence on the association between socioeconomic factors and oral health among older adults was conducted. The aim was to synthesise evidence on the association between socioeconomic factors, captured by education, income, occupation and multi‐aspect measures, and oral health (dentition status, dental caries, periodontal disease, dry mouth, oral function, oral health behaviours, and oral health‐related quality of life) in older adults aged 75 years and over.
+
+2 Methods
+
+This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines [19]. It was registered in the International Systematic Review Registry (PROSPERO; Registration number: CRD420251231319).
+
+2.1 Search Strategy
+
+The databases Medline (PubMed), Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for literature published from inception to 15th November 2025, in accordance with the eligibility criteria. The search strategy was devised in common for this paper and a related systematic review on the association between social support and oral health in the same population group and the detailed eligibility criteria and search terms used are presented in Table 1.
+
+TABLE 1 Research question, inclusion and exclusion criteria and search terms.
+
+Focus question	What is the association of socioeconomic factors with oral health in older adults?	
+Criteria	Inclusion criteria	(1) Studies reporting on the impact of socioeconomic factors on oral health in older adults (≥ 75 years), or the study population had a mean age of 75 years (~75). (2) Socioeconomic context includes factors such as income level, education level, occupation, access to dental services, healthcare system structures and policy‐related influences. (3) Oral health includes clinical indicators (e.g., caries, periodontal disease, tooth loss), functional measures (chewing ability, pain), and behavioural factors (dental visits, oral hygiene habits). (4) Sample size ≥ 10 participants per study group	
+Exclusion criteria	(1) Age < 75 years. (2) Case reports/series	
+Search terms	Population	#1 [MeSH]: Dental Care for Aged
+
+#2 [All fields]: Elder* OR Geriatric Population* OR Geriatric Patient* OR Ageing Population OR Aged 60 OR 60 year* OR Gerodont* OR Aged 75 OR 75 year* OR Aged 80 OR 80 year* OR Senior* OR Care‐depend* OR Older Adults OR Older People
+
+	
+Intervention or exposure	#3 [MeSH]: Social support OR Social determinants of health OR Socioeconomic factors OR Health inequities OR Health services accessibility
+
+#4 [All fields]: Health inequity OR Oral health disparities OR Social isolation OR Community engagement OR Caregiver support OR Family support OR Income level OR Low‐income OR High‐income OR Economic status OR Education level OR Health literacy OR Access to dental care
+
+	
+Outcome	#5 [MeSH]: Oral Health OR Tooth Loss OR Jaw, Edentulous OR Tooth demineralization OR Periodontal Diseases OR Dental pulp diseases OR Dentine sensitivity OR Quality of Life OR Xerostomia OR Mucositis OR Stomatitis OR Candidiasis, Oral
+
+#6 [All fields]: tooth loss OR edent* OR missing teeth OR Caries OR Carious OR Decay* OR DMF‐T OR DMFT OR demineralization OR periodont* OR Peri‐implant* OR Peri‐mucositis OR hypersensitivity OR Tooth sensitivity OR oral health‐related quality of life OR OHRQoL OR Oral Health Impact Profile OR OHIP OR Oral Impact on Daily Performances OR OIDP OR Self‐reported oral health OR Perceived oral health OR Xerostomia OR Mucositis OR Stomatitis OR Candidiasis OR Hyposalivation OR Dry mouth
+
+	
+Search Builder	(#1 OR #2) AND (#3 OR #4) AND (#5 OR #6)	
+
+2.2 Study Selection and Data Extraction
+
+The search results from the databases were imported into Rayyan, an online tool for managing systematic reviews (available at www.rayyan.ai). Duplicates were removed, and the two reviewers (SS and SP) independently screened the titles and abstracts of all articles for eligibility. Then, the full texts of potentially eligible studies were retrieved and reviewed. In cases where potentially eligible studies were published in languages other than English, translations were obtained using DeepL, a non‐commercial AI‐based online translation platform (https://www.deepl.com), to facilitate data extraction and interpretation. This happened for one article and the translated article was quantitative and straightforward to interpret. It was cross‐checked by two researchers (SP and SS) to ensure accuracy. Subsequently, any discrepancies were resolved through consensus among all authors. To maintain consistency in the screening process, inter‐investigator reliability was evaluated through Cohen's unweighted kappa (κ) [20].
+
+The data were then extracted and summarised in a pre‐structured Excel sheet. To maximise the inclusion of available evidence, the extraction process was not limited to the main findings of each included study but also covered baseline data that were relevant to the research question. Studies were included if they reported data on individuals aged 75 years or older (even if the study also included younger adults), or if the study sample had a mean age of 75 years, with studies with a mean age of 74.5 years or higher rounded up to 75 years and therefore included. Information extracted included: author(s), publication year, title, sample country/countries, aim and objectives, study design, population studied (e.g., community‐dwelling, institutionalised, or mixed), age (mean or youngest), study duration (where available), sample size, socioeconomic factors, oral health measure(s) and the type of data available (e.g., cross‐sectional or cohort or both). The data extracted were independently cross‐checked by the two reviewers (SS and SP).
+
+Socioeconomic factors were measured in the extracted manuscripts by a range of indicators such as income, occupation, education, and social class [9]. Across studies, these indicators were inconsistently reported, while some studies have also used measures that combine multiple socioeconomic factors, such as neighbourhood deprivation, which we refer to as multi‐aspect. In this review, socioeconomic factors are presented through two different ways: (1) socioeconomic position (SEP), which refers to income, occupation, and a multi‐aspect parameter, whereas (2) education was addressed separately. This was done to allow for separate meta‐analyses of the two most commonly reported relevant factors, that is, income and education, as a single socioeconomic parameter had to be selected to avoid double‐counting. For the meta‐analyses on the SEP, income was prioritised, and occupation was used when income was missing from the data. No studies reported a multi‐aspect SEP measure in combination with income or occupation. The oral health aspects identified in this review are reported using five domains: (1) dentition status, (2) oral conditions (dental caries, periodontal disease, dry mouth), (3) oral function, (4) oral health behaviours, and (5) oral health‐related quality of life (OHRQoL).
+
+2.3 Quality Assessment
+
+The risk of bias in the included studies was assessed based on the type of data included. This was independently evaluated by both reviewers (SS and SP) using the Newcastle–Ottawa Scale (NOS) for cohort studies [21] when the meta‐analysis used cohort data, and an adapted version of the NOS [22] when the meta‐analysis included cross‐sectional studies.
+
+2.4 Data Synthesis
+
+In addition to the analyses provided in the included studies, any relevant data from the descriptive analyses (e.g., sample sizes for those aged ≥ 75 years or for specific socioeconomic categories) that could be linked to provide derived estimates on the association between socioeconomic factors and oral health were extracted and analysed using unadjusted odds ratios (ORs) for categorical outcomes and mean differences (MDs) for continuous outcomes. Where feasible, meta‐analyses of evidence on the association between oral health and socioeconomic factors were performed by subgroup across SEP and education categories. These results were further stratified by population (e.g., institutionalised, community‐dwelling, or mixed) to provide greater granularity. Studies were excluded from the meta‐analyses if only adjusted estimates were available, if the available data were insufficient for calculating unadjusted effects, or if the included studies used convenience sampling. These studies, along with those reporting varied oral health measures, which could not be merged for meta‐analysis, were summarised narratively.
+
+The risk of publication bias was evaluated using a funnel plot, which was generated when at least five studies were available. Funnel plots were also used for sensitivity analyses to identify studies that most strongly influenced the meta‐analysis in cases of moderate to high heterogeneity. For studies reporting results based on the same sample, only the most recent data were included in the meta‐analyses. All statistical analyses were conducted in RStudio (version 4.5.0) using the meta package.
+
+3 Results
+
+The search yielded 13,197 records, of which 11,872 remained after removing duplicates in Rayyan. There was high consistency in the independent screening for the title and abstract, and for full text, with kappa values of 0.74 and 0.81, respectively (Figure 1). The excluded studies with reasons for exclusion are provided in Appendix S1.
+
+FIGURE 1 PRISMA 2020 flow diagram of study selection. [Colour figure can be viewed at wileyonlinelibrary.com]
+
+3.1 Study Characteristics
+
+A total of 68 studies were included in this review [23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90]. The majority of extracted data used were from cross‐sectional studies [23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90], with only three studies providing cohort data [35, 65, 74]. One included study was in Japanese [85]. The study populations predominantly included community‐dwelling older adults, with a smaller number of studies conducted among institutionalised populations (n = 25) [29, 30, 33, 34, 38, 45, 46, 47, 49, 52, 58, 59, 61, 65, 67, 69, 72, 79, 81, 84, 86, 87, 88, 89, 90]. All included studies are described in Table 2.
+
+TABLE 2 Included studies with the association of socioeconomic factors and oral health in older adults.
+
+Authors, year	Country	Study design	Type of data	Population	Age mean (SD)	Sample size a	Socioeconomic factors	Oral health domains	
+					
+Aida et al. 2011 [23]	Japan	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	74.9 (6.6)	21,736	Education	
+
+					
+Avlund et al. 2005 [24]	Sweden	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 80	157	SEP (occupation), Education	
+
+	
+
+		
+
+		
+Avlund et al., 2001 [25]	Sweden	Cohort	Cross‐sectional	Community‐dwelling	> or equal 75	411	SEP (income), Education	
+
+		
+
+	
+
+		
+Bakker et al. 2021 [26]	Netherlands	Longitudinal cohort	Cross‐sectional	Community‐dwelling	> or equal 75	168,122	SEP (multi‐aspect)	
+
+					
+Brothwell et al., 2008 [27]	Canada	Cross‐sectional	Cross‐sectional	Community‐dwelling	76.2 (7.1)	1751	SEP (income, occupation), Education				
+
+		
+Castrejón‐Pérez et al., 2017 [28]	Mexico	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	79.2 (7.1)	647	Education					
+
+	
+Cocco et al., 2018 [29]	Italy	Cross‐sectional	Cross‐sectional	Institutionalised	84.1 (9.7)	1654	SEP (multi‐aspect)	
+
+					
+Dai et al., 2023 [30]	China	Cohort and cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	85.4 (10.5)	5403	Education	
+
+					
+Dye et al., 2019 [31]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	11,476	SEP (income)	
+
+					
+Edman et al., 2016 [32]	Sweden	Cross‐sectional	Cross‐sectional	Community‐dwelling	equal 75, equal 85	864	SEP (income), Education		
+
+				
+Evren et al., 2011 [33]	Turkey	Cross‐sectional	Cross‐sectional	Institutionalised	76.5 (7.9)	269	SEP (income)				
+
+		
+Ferreira et al., 2008 [34]	Brazil	Cross‐sectional	Cross‐sectional	Institutionalised	79.0 (9.1)	335	SEP (income), Education	
+
+					
+Ganbavale et al., 2024 [35]	Britain	Cohort and cross‐sectional	Cohort and cross‐sectional	Community‐dwelling	78.7	2137	SEP (multi‐aspect)	
+
+	
+
+				
+Go et al., 2022 [36]	Korea	Retrospective cohort	Cross‐sectional	Community‐dwelling
+
+	> or equal 75	Not mentioned	SEP (income)	
+
+					
+Griffin et al., 2012 [37]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	Not mentioned	SEP (income)	
+
+	
+
+				
+Hassel et al., 2006 [38]	Germany	Cross‐sectional	Cross‐sectional	Institutionalised	83.3	158	Education					
+
+	
+Hatta et al., 2018 [39]	Japan	Cohort	Cross‐sectional	Community‐dwelling	between 79 ‐ 81	463	SEP (income), Education	
+
+					
+Heegaard et al. [40]	Denmark	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	75.5	782	SEP (income), Education	
+
+					
+Holm‐Pedersen et al., 2006 [41]	Sweden	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 80	101	SEP (occupation), Education		
+
+				
+Hsu et al., 2013 [42]	Taiwan	Cross‐sectional	Cross‐sectional	Community‐dwelling b	76.0 (0.4)	332	SEP (income), Education					
+
+	
+Hunt et al., 1985 [42]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	3600	SEP (occupation), Education	
+
+					
+Inomata et al., 2017 [44]	Japan	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	between 79 ‐ 81	760	SEP (income), Education	
+
+					
+Iosif et al., 2021 [45]	Romania	Cross sectional	Cross‐sectional	Institutionalised	81.5 (median)	50	Education					
+
+	
+Islas‐Granillo et al., 2016 [46]	Mexico	Cross‐sectional	Cross‐sectional	Institutionalised	79.1 (9.8)	139	Education	
+
+					
+Islas‐Granillo et al., 2014 [47]	Mexico	Cross‐sectional	Cross‐sectional	Institutionalised	79.1 (9.8)	139	Education						
+Iwasaki et al.,2018 [48]	Japan	Cohort	Cross‐sectional	Community‐dwelling	75.0	322	SEP (income), Education	
+
+					
+Janssens et al. [49]	Belgium	Cross‐sectional	Cross‐sectional	Institutionalised	83.9 (8.5)	712	SEP (income)	
+
+					
+Jensen et al., 2008 [50]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	79.1 (7.5)	641	SEP (income)					
+
+	
+Kim et al. 2018 [51]	Korea	Cross‐sectional	Cross‐sectional	Community‐dwelling
+
+	82.7	241	Education	
+
+		
+
+			
+Kim et al., 2009 [52]	Korea	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	75.4 (7.7)	409	SEP (income), Education					
+
+	
+Komiyama et al., 2016 [53]	Japan	Cohort	Cross‐sectional	Community‐dwelling	75.2 (4.4)	834	Education	
+
+			
+
+		
+Komulainen et al., 2012 [54]	Finland	Cross‐sectional	Cross‐sectional	Community‐dwelling	80.6 (3.6)	168	Education				
+
+		
+Krustrup et al., 2008 [55]	Denmark	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	equal 85	176	SEP (income, occupation), Education	
+
+	
+
+				
+Lee et al., 2022 [56]	Taiwan	Cross‐sectional	Cross‐sectional	Community‐dwelling b	74.7 (8.2)	202	SEP (income), Education					
+
+	
+Liang et al., 2020 [57]	Taiwan	Cross‐sectional	Cross‐sectional	Community‐dwelling b	79.0	166	SEP (income), Education			
+
+		
+
+	
+Ling et al., 2014 [58]	New Zealand	Case series and cross‐sectional	Cross‐sectional	Institutionalised b	82.6 (6.6)	179	SEP (multi‐aspect)	
+
+	
+
+				
+Lundgren et al., 1995 [59]	Sweden	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	equal 88	354	Education				
+
+		
+Musacchio et al., 2007 [60]	Italy	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	76.8 (8.7)	3054	SEP (income), Education	
+
+					
+Niesten et al., 2017 [61]	Netherlands	Cross‐sectional	Cross‐sectional	Institutionalised	85.4 (7.1)	126	SEP (multi‐aspect)				
+
+		
+Osterberg et al., 1995 [62]	Sweden, Denmark, Finland	Cross‐sectional	Cross‐sectional	Community‐dwelling	equal 75	945	SEP (income)	
+
+					
+Paulander et al., 2003 [63]	Sweden	Cross‐sectional	Cross‐sectional	Community‐dwelling	equal 75	238	Education	
+
+	
+
+				
+Phipps et al., 2009 [64]	US	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling b
+
+	74.6	1210	Education	
+
+	
+
+				
+Qi et al., 2023 [65]	China	Cohort and cross‐sectional	Cohort	Community‐dwelling and institutionalised	80.4 (9.7)	4268	SEP (income), Education	
+
+					
+Ramsay et al., 2015 [66]	Britain	Cross‐sectional	Cross‐sectional	Community‐dwelling	78.0	1612	SEP (occupation)	
+
+	
+
+				
+Rapp et al., 2017 [67]	France	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	82.5 (6.3)	1241	Education		
+
+				
+Rise et al., 1982 [68]	Norway	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	530	Education				
+
+		
+Rocha‐Ortiz et al., 2023 [69]	Mexico	Cross‐sectional	Cross‐sectional	Institutionalised b	81.3 (9.0)	257	Education	
+
+					
+Sato et al., 2016 [70]	Japan	Cohort and cross‐ sectional	Cross‐sectional	Community‐dwelling	equal 80	245	SEP (income), Education		
+
+				
+Shimamura et al., 2022 [71]	Japan	Cross‐sectional	Cross‐sectional	Community‐dwelling	76.2 (7.4)	1616	SEP (income, occupation)	
+
+					
+Silva et al., 2014 [72]	Australia	Cross‐sectional	Cross‐sectional	Institutionalised	83.0	237	SEP (income)	
+
+	
+
+				
+Singhal et al., 2021 [73]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	135,192	SEP (income)	
+
+					
+Siukosaari et al., 2005 [74]	Finland	Cohort and cross‐sectional	Cohort and cross‐sectional	Community‐dwelling	> or equal 75	71	Education		
+
+				
+Siukosaari et al., 2012 [75]
+
+	Finland	Cross‐sectional	Cross‐sectional	Community‐dwelling
+
+	> or equal 75	170	Education	
+
+	
+
+				
+Syrjälä et al.,2011 [76]	Finland	Cross‐sectional	Cross‐sectional	Community‐dwelling	79.8 (3.6)	154	Education		
+
+				
+Syrjälä et al., 2010 [77]	Finland	Cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 75	523	Education	
+
+					
+Tennstedt et al., 1994 [78]	US	Cross‐sectional	Cross‐sectional	Community‐dwelling	77.5 (5.5)	633	Education				
+
+		
+Thorstensson et al., 2010 [79]	Sweden	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	> or equal 80	357	SEP (income), Education	
+
+					
+Tsakos et al., 2009 [80]	UK	Cross‐sectional	Cross‐sectional	Community‐dwelling	74.7	1040	SEP (income), Education					
+
+	
+Uludamar et al., 2011 [81]	Turkey	Cross‐sectional	Cross‐sectional	Institutionalised	76.6 (9.2)	346	SEP (income)	
+
+	
+
+		
+
+		
+Vu et al., 2022 [82]	Korea	Cross‐sectional	Cross‐sectional	Community‐dwelling	76	675	Education					
+
+	
+Wright et al., 2018 [83]	Australia	Longitudinal and cross‐sectional	Cross‐sectional	Community‐dwelling	> or equal 78	524	SEP (income)	
+
+	
+
+				
+Wu et al., 2018 [84]	China	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	75.3 (6.7)	195	SEP (income, occupation), Education					
+
+	
+Yanagisawa et al., 2023 [85]	Japan	Cross‐sectional	Cross‐sectional	Community‐dwelling	75.1 (6.9)	739	SEP (income), Education	
+
+					
+Yang et al., 2022 [86]	China	Cohort and cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	> or equal 80	5513	SEP (income), Education	
+
+					
+Zini et al., 2008 [87]	Israel	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalized b	75.7 (8.1)	344	SEP (income), Education					
+
+	
+Zini et al., 2011 [88]	Israel	Case control and cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised b	75.7 (8.1)	344	SEP (income), Education				
+
+		
+Zuluaga et al., 2012 [89]	Spain	Cross‐sectional	Cross‐sectional	Institutionalised	82.9 (7.6)	295	Education					
+
+	
+Chan et al., 2025 [90]	China	Cross‐sectional	Cross‐sectional	Community‐dwelling and institutionalised	82.6 (11.2)	7796	SEP (income, occupation), Education						
+Note: , Oral health domains reported in the study; , Dentition status; , Oral conditions: dental caries, periodontal disease, and dry mouth; , Oral function; , Oral health behaviours; , Oral Health‐Related Quality of Life; SEP: socioeconomic position.
+
+a Sample size reported based on the extracted data in this review.
+
+b Employed convenience samples.
+
+3.2 Risk of Bias and Quality Assessment
+
+The risk of bias and quality of the included cross‐sectional and cohort studies were assessed as ranging from moderate to low. Eight studies were considered to have low population representativeness due to employing convenience sampling [42, 56, 57, 58, 64, 69, 87, 88]. Detailed assessments are provided in Appendix S2 (Tables 1–3).
+
+3.3 Synthesis of Results
+
+The overall information on the associations between socioeconomic factors and oral health is presented in Appendix S3 (Table 1). Twelve meta‐analyses were conducted, of which four were further examined using funnel plots and demonstrated acceptable levels of publication bias. These included the associations between: (1) SEP and edentulism prevalence, (2) SEP and prevalence of lacking functional dentition (i.e., having fewer than 20 natural teeth), (3) education and edentulism prevalence, and (4) education and prevalence of lacking functional dentition (Appendix S4: Figures S20–S23).
+
+3.3.1 Dentition Status
+
+This review identified key indicators of dentition status, including the number of missing teeth, edentulism prevalence, and prevalence of lacking functional dentition (n = 40) [23, 24, 25, 26, 29, 30, 31, 34, 35, 36, 37, 39, 40, 43, 44, 46, 48, 49, 51, 53, 55, 58, 60, 62, 63, 64, 65, 66, 69, 71, 72, 73, 75, 77, 79, 81, 83, 85, 86, 90].
+
+The meta‐analysis of SEP (Figure 2a), which used income‐based [49, 72, 81, 83] parameters, showed that older adults from low SEP had, on average, two fewer teeth than those from higher SEP (MD 2.11; 95% CI: 0.73, 3.50), with moderate heterogeneity (I2 = 68.4%). Population‐stratified analysis showed associations in both the community‐dwelling [83] (MD 1.93; 95% CI: 0.02, 3.84) and institutionalised [49, 72, 81] (MD 2.77; 95% CI: 1.42, 4.12) populations (Appendix S4: Figure S1). Similarly, meta‐analyses on education and missing teeth [46, 63, 75] documented that lower education levels were associated with a greater number of missing teeth (MD 2.61; 95% CI: 1.15, 4.06) than higher education levels, with no heterogeneity (Figure 2b). Population‐stratified analysis showed an association in community‐dwelling populations [63, 75] (MD 2.97; 95% CI: 1.39, 4.55) (Appendix S4: Figure S2). This association was also supported by three adjusted analyses [55, 65, 69], one each in a community population [55], institutionalised population [69], and a mixed sample comprising community‐dwelling and institutionalised older adults [65].
+
+FIGURE 2 Forest plot showing the mean difference in the number of missing teeth. (a) Socioeconomic position; (b) Education level.
+
+In the meta‐analyses of edentulism (n = 10) [26, 34, 35, 43, 60, 66, 71, 73, 81, 90] and lacking a functional dentition (n = 7) [29, 40, 48, 60, 66, 71, 90], older adults in lower SEP were more likely to experience edentulism (OR 1.53; 95% CI: 1.18, 1.97) and lack functional dentition (OR 1.59; 95% CI: 1.15, 2.19) than those in higher SEP, with both meta‐analyses showing high heterogeneity (Figures 3a and 4a). Population‐stratified analysis showed that lower SEP was associated with edentulism in community‐dwelling population samples [26, 35, 43, 60, 66, 71, 73] (OR 1.67; 95% CI: 1.21, 2.32) with high heterogeneity (I2 = 99.4%), whereas the evidence showed no association in institutionalised populations [34, 81] (OR 1.25; 95% CI: 0.04, 41.71) (Appendix S4: Figure S3). Similarly, associations were consistent across community‐dwelling populations [40, 48, 60, 66, 71] for lacking functional dentition (OR 1.84; 95% CI: 1.33, 2.54) (Appendix S4: Figure S4). Sensitivity analysis excluding the two outlier studies on the meta‐analysis on edentulism [26, 73] reduced heterogeneity from I2 = 99.2% to 86.6% without much altering the pooled estimate (Appendix S4: Figure S5). Sensitivity analysis for the prevalence of lacking functional dentition reduced heterogeneity from 83.4% to 74.2% while maintaining a comparable pooled estimate (Appendix S4: Figure S6).
+
+FIGURE 3 Forest plot showing the odds ratio in the prevalence of edentulism. (a) Socioeconomic position; (b) Education level.
+
+FIGURE 4 Forest plot showing the odds ratio in the prevalence of lacking a functional dentition. (a) Socioeconomic position; (b) Education level.
+
+Moreover, the meta‐analyses on education level documented similar associations, with low education being associated with a higher prevalence of edentulism (n = 9) [30, 34, 43, 51, 53, 60, 63, 77, 90] (OR 1.85; 95% CI: 1.45, 2.36) (Figure 3b) and lacking functional dentition (n = 9) [23, 30, 40, 48, 53, 60, 75, 77, 90] (OR 2.18; 95% CI: 1.58, 3.00) (Figure 4b), compared with higher education levels. Population‐stratified analyses by education showed associations in both community‐dwelling [43, 51, 53, 60, 63, 77] (OR 1.71; 95% CI: 1.17, 2.51) and institutionalised [34] (OR 2.82; 95% CI: 1.68, 4.74) populations for edentulism (Appendix S4: Figure S7). Low education was also associated with lacking functional dentition in community‐dwelling populations [23, 40, 48, 53, 60, 75, 77] (OR 1.98; 95% CI: 1.31, 3.00) and studies covering community‐dwelling and institutionalised populations [30, 90] (OR 2.89; 95% CI: 2.55, 3.27), with no study reporting exclusively from institutionalised settings (Appendix S4: Figure S8). Sensitivity analyses further reduced heterogeneity from I2 = 85.4% to 30.2% and from I2 = 93.8% to 83.5%, respectively, while preserving similar pooled estimates (Appendix S4: Figures S9 and S10). The remaining substantial heterogeneity in the prevalence of edentulism and lacking functional dentition across studies on SEP and education corresponded to variation observed in individual‐adjusted analyses, which reported both associations [25, 35, 62, 79] and no associations [23, 24, 60, 86] across community‐dwelling [23, 24, 25, 35, 60, 62] and mixed [79, 86] populations.
+
+3.3.2 Oral Conditions: Dental Caries, Periodontal Disease and Dry Mouth
+
+For dental caries, meta‐analyses by SEP were conducted using the number of decayed teeth (n = 3) [72, 81, 83]. Older adults in low SEP had a slightly higher number of decayed teeth than those in higher SEP (MD 0.45; 95% CI: 0.15, 0.75), with no heterogeneity (Appendix S4: Figure S11). Population‐stratified analysis showed an association in a community‐dwelling population [83] (MD 0.52; 95% CI: 0.18, 0.86) (Appendix S4: Figure S12). This finding was consistent with a study that showed an association between SEP and the number of carious teeth in adjusted analyses [24]. Since the number of studies with education level was limited (n = 5) and the reported measures were heterogeneous, a meta‐analysis could not be performed for these studies [24, 32, 55, 63, 74]. Two of these studies [32, 63] reported associations in unadjusted analyses, while all three studies that performed adjusted analyses showed no associations [24, 55, 74].
+
+For periodontal disease, 12 included studies [35, 37, 41, 63, 64, 66, 67, 70, 74, 75, 76, 83] reported associations with socioeconomic factors; however, meta‐analysis was not possible. Among studies that conducted adjusted analyses, one study, using a multi‐aspect SEP, demonstrated an association [35], whereas another study, using occupation‐based classification and education level, reported non‐significant results [41].
+
+Lastly, two studies were included for the dry mouth [35, 47]. Of these, only one study used adjusted analysis and reported a higher prevalence of dry mouth (assessed through the Xerostomia Inventory Scale) among community‐dwelling older adults in more deprived neighbourhoods, in cross‐sectional data, but not in 8‐year cohort data [35].
+
+3.3.3 Oral Function
+
+This review identified three studies [25, 51, 57] that examined the association between socioeconomic factors and oral function. A meta‐analysis could not be conducted due to the limited number of studies and the heterogeneity of measures. Adjusted analyses showed that community‐dwelling older adults with a sufficient but not affluent economic status and less than 3 years of education had higher odds of poor oral function [57].
+
+3.3.4 Oral Health Behaviours
+
+Thirteen studies [24, 25, 27, 33, 53, 54, 59, 61, 68, 73, 78, 81, 88] examined the association between socioeconomic factors and oral health behaviours, primarily focusing on dental care attendance among older adults. Meta‐analysis with moderate heterogeneity (I2 = 58.8%) showed that older adults in low SEP were 2.42 (95% CI: 1.60, 3.66) times more likely to report irregular use of dental services compared with those in high SEP across both occupation [61] and income parameters [33, 73, 81] (Appendix S4: Figure S13). Population‐stratified analyses showed that associations were stronger in community‐dwelling [73] (OR 3.02; 95% CI: 2.92, 3.13) than in institutionalised populations [33, 61, 81] (OR 1.96; 95% CI: 1.40, 2.75) (Appendix S4: Figure S14). Adjusted analyses [24, 25, 27, 61, 88] reported the same direction of this association, with studies showing associations across community‐dwelling [25, 27] and mixed populations [88].
+
+A meta‐analysis of two community‐dwelling population studies [53, 68] found no association between education level and dental attendance (OR: 3.05; 95% CI: 0.00, 6745.81) (Appendix S4: Figure S15). Several studies that conducted adjusted analyses reported a positive association between higher education level and more frequent dental visits [25, 27, 59, 78], while one reported no association [24].
+
+Additionally, three studies [33, 61, 81] from institutionalised settings assessed the association between SEP and toothbrushing frequency. The pooled meta‐analysis yielded no association (OR 1.87; 95% CI: 0.44, 7.93) with moderate heterogeneity (I2 = 61.2%) (Appendix S4: Figure S16).
+
+3.3.5 OHRQoL
+
+This review included 13 studies that examined the association between socioeconomic factors and OHRQoL [28, 38, 42, 45, 50, 52, 56, 57, 80, 82, 84, 87, 89], using two instruments: the Oral Health Impact Profile‐14 (OHIP‐14) (n = 8) [28, 38, 45, 50, 52, 56, 82, 87] and the Geriatric Oral Health Assessment Index (GOHAI) (n = 5) [42, 57, 80, 84, 89]. The meta‐analysis (n = 2) [52, 80] using a community‐dwelling sample [80] and a mixed population sample [52] showed that older adults with low income were associated with poorer OHRQoL (standardised mean difference: SMD 0.17; 95% CI: 0.07, 0.28) than those with higher SEP, with no heterogeneity (Appendix S4: Figure S17). Two individual studies also reported associations between low income and poor OHRQoL in adjusted analyses [52, 57], but others found no significant results [56, 80, 84, 87].
+
+Furthermore, the meta‐analysis (n = 3) [28, 52, 80] indicated that older adults with low education levels reported a marginally poorer OHRQoL (SMD 0.21; 95% CI: 0.11, 0.30) than those with high education levels, with almost no heterogeneity (I2 = 0.4%) (Appendix S4: S18). Population‐stratified analysis revealed associations for community‐dwelling [28, 80] (SMD 0.23; 95% CI: 0.13, 0.34) and mixed population [52] samples (SMD 0.08; 95% CI: 0.13, 0.29) (Appendix S4: Figure S19). Findings from individual studies that reported adjusted analyses indicated mostly no associations across community‐dwelling [28, 56, 57, 82], institutionalised [89], and mixed [52, 84] populations, although three studies showed that low education was associated with poor OHRQoL across different populations [38, 80, 87]. In contrast, one study from Taiwan reported higher education to be associated with poorer OHRQoL [42].
+
+4 Discussion
+
+This systematic review and meta‐analysis provides comprehensive evidence that socioeconomic factors were consistently associated with poorer oral health and behaviours in older adults aged 75 years and over. More specifically, meta‐analyses documented that socioeconomic disadvantage was associated with poor dentition status (fewer teeth, higher prevalence of edentulism, and higher prevalence of lacking a functional dentition), higher numbers of decayed teeth, irregular dental attendance, and generally with poor OHRQoL. Overall, associations were stronger in meta‐analyses for dentition status than in any other meta‐analyses. Similar patterns were generally observed for periodontal disease, oral function, and dry mouth, although no meta‐analysis could be performed due to the limited available evidence and varied outcome measures.
+
+To our knowledge, this is the most comprehensive systematic synthesis of evidence, including meta‐analysis, on the association of socioeconomic factors with several aspects of oral health in older adults (≥ 75). We have conducted robust sensitivity analyses, where appropriate, that supported the consistency of our findings and have used meta‐analysis cautiously, refraining from forcing synthesis when evidence was limited or outcomes were heterogeneous. Meta‐analysis was performed using unadjusted estimates, as few studies reported adjusted analyses. Findings should therefore be interpreted cautiously, given that the study associations are prone to confounding in general and in this population in particular, due to existing multi morbidities. To support interpretation, adjusted analyses were presented narratively alongside the meta‐analysis. As relevant cohort studies were scarce in this population, the included studies were limited by their predominantly cross‐sectional design; therefore, not allowing causal inferences. Considering also that participants were aged 75 years and over, the findings may also be affected by survival bias, with healthy individuals from lower socioeconomic groups more likely to survive than their unhealthy counterparts in the same socioeconomic category, which may potentially attenuate the associations. Another limitation is the possibility of reverse causality, which is difficult to disentangle in cross‐sectional data, thereby limiting interpretation.
+
+The use of different sampling frames across the different studies may have affected the generalisability of the findings. Heterogeneity was high across several meta‐analyses, and this likely reflects variation in population contexts. To address this, we stratified analyses by studies employing community‐dwelling samples, those with institutionalised samples, and those using both community‐dwelling and institutionalised samples. This has helped highlight the potential role of the nature and context of the different samples used. Some unexplained variability remained in the population‐stratified analyses, potentially due to differences in measures, further limiting the generalisability of the pooled estimates. It is also worth noting the limited number of studies among institutionalised older adults. Moreover, the included studies were primarily conducted in the Global North, with very few undertaken in the Global South within this population group. Overall, the findings should be interpreted carefully, as the studies used a wide range of measurement instruments and outcomes, each with varying definitions.
+
+Socioeconomic factors showed the strongest associations with dentition status among the several aspects of oral health studied here. Low SEP was associated with poor dentition status, including fewer teeth, higher edentulism prevalence, and a greater likelihood of functional dentition loss. Our findings are consistent with the literature showing that socioeconomic disadvantage is associated with poor dentition status [5, 91, 92, 93, 94, 95, 96, 97]. The findings emphasise that socioeconomic factors have a crucial role in shaping oral health, also in older adulthood. It is possible that this could be through biological, material, behavioural, and psychosocial mechanisms, potentially due to cumulative exposure to risk factors across the life course, which is predominantly seen in tooth loss, as it is the final outcome of oral diseases. Other studies have highlighted the influence of accumulated risk factors over the life course on dentition status [98, 99].
+
+Socioeconomic factors were generally associated with dental caries, periodontal disease, and dry mouth, although evidence of association was inconsistent for periodontal disease and limited for dry mouth. Low SEP was associated with more decayed teeth in this meta‐analysis, and with periodontal disease and dry mouth in adjusted analyses [35]. It implies that SEP can adversely affect these oral conditions. Previous research in younger population groups showed that socioeconomic disadvantage was associated with a higher likelihood and greater severity of both dental caries and periodontal diseases [15, 16, 94, 100], highlighting the role of socioeconomic factors in these conditions. However, older adults aged 75 years or older retain fewer natural teeth, particularly those in lower SEP, and this may also be associated with a lower likelihood of oral diseases, which could partially explain the variable associations observed in this review. For dry mouth, the evidence was scarce, with only two studies and therefore should be interpreted cautiously.
+
+Low education and non‐affluent economic status were generally associated in adjusted analyses with poor oral function [25, 51, 57], though this finding was based on only three studies and no meta‐analysis was conducted due to the limited available evidence. This association may be indirect, through poor dentition status. For example, chewing problems were higher among older edentulous participants [101] and chewing ability has been shown to be associated with childhood adversity [102]. Moreover, socioeconomic factors also influence the ability to seek treatment and the type of treatment, thereby potentially affecting oral function [103, 104, 105].
+
+Socioeconomic factors were also associated with oral health behaviours, although education‐based differences in oral health behaviours were inconclusive. Low SEP was associated with irregular dental attendance [33, 61, 73, 81, 88]. This implies that low SEP may act as a barrier for dental attendance and thereby has the potential to influence other aspects of oral health, such as dentition status, dental caries, periodontal disease, and oral function. Studies have documented the generally modest role of behavioural pathways in explaining socioeconomic inequalities in oral health [7, 8, 95, 106, 107, 108, 109, 110]. Some qualitative studies highlighted cost as a barrier, which is related to socioeconomic factors [103, 104, 105, 111, 112]. Finally, poor SEP was associated with poor OHRQoL across different instruments [42, 52, 80]. OHRQoL captures the combined consequences of poor oral health on the quality of life. These findings are consistent with the broader literature on socioeconomic inequalities in OHRQoL [7, 8, 108, 109, 110].
+
+The findings from this review highlight the relevance of socioeconomic factors for the oral health of older adults aged 75 years and older. At the population level, socioeconomic factors should be considered in health services planning, particularly in resource allocation and the development of suitable financial mechanisms to promote equity. At the clinical level, they can be considered in treatment planning and determining recall intervals, thereby enabling patient‐centred care. Future research could develop, test, and validate multi‐dimensional risk indices for older adults that integrate socioeconomic factors.
+
+5 Conclusion
+
+This systematic review and meta‐analysis showed that socioeconomic disadvantage was consistently associated with worse oral health and poorer behaviours among adults aged 75 years and older. Associations were more pronounced for dentition status, with people in socioeconomic disadvantage having a higher prevalence of edentulism, fewer teeth, and a higher prevalence of not having a functional dentition than their more affluent counterparts. Socioeconomic factors should be considered to inform prevention, clinical decision‐making, and oral healthcare planning for the ageing population.
+
+Author Contributions
+
+F.M., G.T., B.J. and M.S. conceived the initial study idea. S.S.S. and S.P. conducted the research study together and were supported by F.M., G.T., B.J. and M.S. S.S.S. and S.P. prepared the first draft, and all authors were involved in reading, critically revising, editing and approving the final manuscript.
+
+Funding
+
+The authors have nothing to report.
+
+Ethics Statement
+
+The authors have nothing to report.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Supporting information
+
+Appendix S1. List of excluded studies with reasons for exclusion.
+
+Appendix S2. Risk of bias and quality assessment of included studies.
+
+Appendix S3. Summary of findings on the association of socioeconomic factors with oral health.
+
+Appendix S4. Supplementary forest and funnel plots of meta‐analyses.
+
+Acknowledgements
+
+The authors would like to thank Dr. Danielle Layton, who is an adjunct Professor at the University of Queensland and a specialist private practitioner in Brisbane, Australia, for her expertise in refining and perfecting our search strategy.
+
+Data Availability Statement
+
+The data analysed in this study are derived from previously published studies included in the systematic review. All data supporting the findings of this study are available within the article and its supporting information. No new primary data were generated for this study.
+
+
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+38 A. J. Hassel , U. Koke , M. Schmitter , and P. Rammelsberg , “Factors Associated With Oral Health‐Related Quality of Life in Institutionalized Elderly,” Acta Odontologica Scandinavica 64, no. 1 (2006): 9–15, 10.1080/00016350500326211.16428176
+39 K. Hatta , K. Ikebe , Y. Gondo , et al., “Influence of Lack of Posterior Occlusal Support on Cognitive Decline Among 80‐Year‐Old Japanese People in a 3‐Year Prospective Study,” Geriatrics & Gerontology International 18, no. 10 (2018): 1439–1446, 10.1111/ggi.13508.30295988
+40 K. Heegaard , K. Avlund , P. Holm‐Pedersen , U. A. Hvidtfeldt , A. Bardow , and M. Grønbaek , “Amount and Type of Alcohol Consumption and Missing Teeth Among Community‐Dwelling Older Adults,” Findings From the Copenhagen Oral Health Senior Study 71 (2011): 2011.00276.x, 10.1111/j.1752-7325.2011.00276.x.22320290
+41 P. Holm‐Pedersen , S. L. Russell , K. Avlund , M. Viitanen , B. Winblad , and R. V. Katz , “Periodontal Disease in the Oldest‐Old Living in Kungsholmen, Sweden: Findings From the KEOHS Project,” Journal of Clinical Periodontology 33, no. 6 (2006): 376–384, 10.1111/j.1600-051X.2006.00922.x.16677325
+42 K. J. Hsu , H. E. Lee , Y. M. Wu , S. J. Lan , S. T. Huang , and Y. Y. Yen , “Masticatory Factors as Predictors of Oral Health‐Related Quality of Life Among Elderly People in Kaohsiung City,” Taiwan. Qual Life Res 23, no. 4 (2014): 1395–1405, 10.1007/s11136-013-0574-7.24241772
+43 R. J. Hunt , J. D. Beck , J. H. Lemke , F. J. Kohout , and R. B. Wallace , “Edentulism and Oral Health Problems Among Elderly Rural Iowans: The Iowa 65+ Rural Health Study,” American Journal of Public Health 75, no. 10 (1985): 1177–1181, 10.2105/ajph.75.10.1177.3898879 PMC1646365
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diff --git a/corpus/healthcare/text/e5bdaca639a539b2.txt b/corpus/healthcare/text/e5bdaca639a539b2.txt
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@@ -0,0 +1,486 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Support Care Cancer
+Journal ID: Support Care Cancer
+NLM Journal ID: 9302957
+
+Supportive Care in Cancer
+
+ISSN: 0941-4355
+EISSN: 1433-7339
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13221355
+PMID: 42213200
+DOI: 10.1007/s00520-026-10801-z
+Article ID: 10801
+Article version: 1
+Subjects: Review
+
+Bibliometric analysis of oncology communication from 1976 to 2025: a focus on narrative medicine
+
+http://orcid.org/0009-0003-2947-0663 Outes Ismael Traba ismael.traba@uca.es
+1 2
+http://orcid.org/0000-0002-0146-5956 Gómez-Carmona Diego 1 2
+http://orcid.org/0000-0003-2270-0924 Galiano-Coronil Araceli 1 2
+1 https://ror.org/04mxxkb11 grid.7759.c 0000000103580096 Faculty of Social Sciences and Communications, Cadiz University, La Asunción University Campus, Avda de La Universidad 5, Jerez de La Frontera, Spain
+2 Instituto Universitario Para El Desarrollo Social Sostenible (INDESS), Jerez de La Frontera, Spain
+Electronic publication date: 2026 May 29
+Print publication date: 2026
+Volume: 34
+Issue: 6
+Electronic Location ID: 592
+Received 2025 Oct 13; Accepted 2026 May 15
+Copyright: © The Author(s) 2026, modified publication 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Clinical communication, Oncology, Narrative medicine, Bibliometric analysis
+
+Funding: Universidad de Cadiz Funding for open access publishing: Universidad de Cádiz/CBUA
+
+issue-copyright-statement: © Springer-Verlag GmbH Germany, part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Clinical communication in oncology has become a central component of supportive cancer care, with direct implications for symptom management, psychosocial distress, decision-making, caregiver support, survivorship, and palliative transitions. This bibliometric analysis examined 949 documents indexed in the Web of Science Core Collection between 1976 and 2025 in order to map the field’s intellectual structure, publication profile, and thematic development. The study combined PRISMA-guided corpus construction with bibliometric techniques including co-citation analysis, thematic clustering, and strategic mapping. The results show sustained growth across five decades, but also a distributed publication profile, moderate international collaboration, and only partial integration across citation communities. A major transition occurred between 2005 and 2007, when communication began to be framed less as information transfer and more as a therapeutic and relational component of care. Within this structure, narrative medicine remains visible mainly as a conceptual orientation rather than as a consolidated methodological line. Thematic development is stronger in psychosocial, patient-centered, and palliative communication than in digitally mediated, developmentally specific, participatory, or structurally informed approaches. Overall, the findings position oncology communication as an established but still uneven component of supportive care, with practical implications for multidisciplinary teams in nursing, psycho-oncology, social work, and palliative care.
+
+Introduction
+
+In oncology care, clinical communication is a central axis that directly affects patients’ quality of life, therapeutic adherence, emotional coping, and shared decision-making. The growing complexity of healthcare settings, marked by the technification of diagnosis, the increase in personalized treatments, and the diversity of cultural values, has positioned communication as an instrumental tool and structural component of cancer care. Recent evidence reinforces this centrality: patient-centered communication significantly improves treatment adherence and emotional well-being [46, 61], while ineffective communication increases the risk of high anxiety, unnecessary hospitalizations, and difficulties in decision-making [11, 49]. However, this consolidation has followed an uneven trajectory, articulated around specific protocols that, although effective locally, hinder the construction of integrated knowledge about the relational and narrative dimensions of cancer care.
+
+The formalization of communication training in oncology has progressed through several stages. Early contributions established communication skills as a domain susceptible to systematic instruction, noting their role in reducing patient anxiety and professional burnout [54]. The SPIKES protocol [4] marked a turning point in standardization for delivering bad news, followed by work addressing the complexities of prognostic disclosure [36, 41]. Meta-analytic evidence has confirmed the effectiveness of training programs [9, 19], and international studies have demonstrated their cost-effectiveness [37, 52]. However, implementation remains uneven, only 23.7% of certified cancer centers in Germany offer regular communication training, citing lack of time, resources, and institutional support [48].
+
+The scope of oncology communication has expanded beyond the clinician-patient dyad. Epstein and Street [34] positioned patient-centered communication at the core of practice, emphasizing shared understanding [5] extended this to prognosis communication and the maintenance of realistic hope in palliative contexts. Cancer is increasingly recognized as a family experience: open communication promotes treatment adherence [15], caregiver burden is a clinical concern in its own right [31] and peer support reduces anxiety and depressive symptoms [56, 63]. Health literacy has been reconceptualized as a civic competence that conditions patients’ capacity to engage in care [58], and calls for regulatory protocols integrating emotional support have appeared in several European contexts [14, 66], though adoption remains limited [20]. This evidence reinforces that clinical communication improves adherence, quality of life, and satisfaction [33, 74, 75], while highlighting the distance between knowledge and routine practice.
+
+This evolution in the field of knowledge highlights a conceptual shift that transcends procedural aspects, with consolidation in medical education and in the management of complex chronic conditions [23]. The study by [29] shows the speed of adaptation in health communication during COVID-19, demonstrating that peripheral fields such as digital communication can be quickly reorganized in the face of disruptive phenomena, while established domains evolve gradually. This phenomenon suggests that oncology communication is in an emerging phase. Furthermore, the work of [47] documents the heterogeneity of fields in transition toward disciplinary maturity. Specifically, the authors state that, in oncology communication, there is specialization within some general subfields, but further research is needed in others. The research by [8] highlights editorial dispersion, typical of emerging disciplines. It points to the absence of standardized methodologies to measure its effects, thereby perpetuating its epistemologically ambiguous position within dominant biomedical hierarchies [2]. Health communication encompasses multiple disciplines, such as psycho-oncology, medical ethics, health sociology, and the social sciences, generating significant conceptual richness but also heterogeneity that makes it difficult to articulate a single frame of reference. This situation is marked by the rapid transformation of the clinical environment, driven by phenomena such as the digitization of care, the reconfiguration of healthcare relationships in the wake of COVID-19, and the emergence of artificial intelligence-based technologies [70, 73]. This evidence reveals a critical gap: no bibliometric analysis has specifically mapped how narrative medicine—which, as formalized by [22], operates as a philosophical reframing of the clinical encounter that recognizes patients’ illness narratives as clinically relevant, as a trainable competence enabling professionals to recognize, absorb, and interpret those narratives, and as a set of specific methods including reflective writing and parallel charts—has been integrated into the intellectual architecture of oncological communication. These three dimensions represent a gradient from conceptual presence to operational practice and focusing on them can reveal which has achieved citation visibility—whether narrative medicine has entered the field as a philosophical reference, as an established competency domain, or as a methodological tradition with its own research base.
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+This is the first bibliometric study to map narrative medicine within oncology communication. Specifically, this study seeks to address the structural, informational, and thematic gaps in scientific production on clinical communication and oncology, as indexed in the Web of Science (WoS), from 1976 to 2025. Using advanced co-occurrence analysis techniques, co-citation networks, and thematic clustering, we will delve into the intellectual architecture to identify emerging themes, key authors, and research gaps. Specifically, the following objectives were established: (a) to study the field of knowledge on clinical communication and oncology through bibliometric analysis of Web of Science; (b) to identify authors, journals, and works that have contributed most frequently, visibly, and impactfully to the construction and scientific development of the field of study; and (c) to discover the main thematic clusters, identifiable conceptual trends in the scientific literature on clinical communication in oncology, and under-explored or emerging areas in order to propose a future research agenda for the discipline.
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+These objectives led to the exploration of the following key questions:
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+Research Question 1: What type of scientific evidence has been published in the Web of Science database regarding communication interventions in the field of oncology, and how has it evolved?
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+Research Question 2: Which journals and authors are the most productive and have the most significant scientific impact in the study of communication interventions in oncology, according to the leading academic indicators?
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+Research Question 3: What thematic clusters and intellectual structures predominate in clinical communication in oncology, and how do narrative approaches position themselves in relation to dominant paradigms, pointing out gaps and emerging lines of research?
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+The following sections present the methodology, results, and discussion.
+
+Methodology
+
+This study is a bibliometric analysis designed to map the intellectual structure and evolution of scientific knowledge on clinical communication in oncology, following the methodological recommendations established by [30] and [76]. The study corpus was limited to the Web of Science Core Collection (WoS), a multidisciplinary database covering more than 250 areas of knowledge and with a selective editorial process that guarantees quality in scientific indexing [24].
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+Search strategy and corpus construction
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+The search equation was constructed using a conceptual block approach, breaking the topic into its fundamental semantic components for subsequent combination using Boolean operators. After a preliminary review of the literature and consultation of specialized thesauri, two main blocks were identified:Block A (Oncology domain): Terms related to cancer, neoplasms, and oncology care
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+Block B (Clinical communication): Terms related to professional–patient interaction and healthcare communication
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+Initial search
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+A refined thesaurus was developed by integrating MeSH descriptors, Scopus thesauri, and WoS. The terminology selection was based on the narrative-relational framework defined in the theoretical section [16, 17, 22], including descriptors such as “narrative medicine,” “empathic communication,” “shared decision-making,” and “breaking bad news” to capture the dimension of interpretive co-creation. The Title (TI) field was prioritized over Topic (TS) to maximize semantic precision, following [62]. The final equation combined both fields and document type filters (article and review) and thematic categories, resulting in 979 documents (April 19, 2025).
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+The result of this first phase is the following search equation:“(TI=(“cancer” OR “neoplasm*” OR “oncolog*” OR “tumor*” OR “carcinoma”) AND TI=(“communication” OR “health communication” OR “doctor-patient communication” OR “patient-provider communication” OR “physician-patient relations”)) AND TS=(“narrative medicine” OR “empathic communication” OR “health literacy” OR “shared decision-making” OR “risk communication” OR “digital communication” OR “breaking bad news” OR “prognostic disclosure” OR “palliative care” OR “end-of-life care” OR “terminal cancer” OR “advanced cancer” OR “psychosocial care” OR “telemedicine” OR “telehealth” OR “mHealth” OR “patient portal*” OR “online support group*” OR “social media communication” OR “treatment adherence” OR “quality of life”) AND DT=(Article OR Review) NOT WC=(Biochemistry & Molecular Biology) and Proceeding Paper or Early Access or Book Chapters (Exclude - Document Types)”
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+Data cleaning and screening
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+The cleaning and management operations were carried out using a combination of Bibliometrix (R) and its graphical interface Biblioshiny, specialized software widely recognized for its ability to analyze metadata, semantic networks, and co-citation structures [3]. The cleaning operations included technical and structural aspects of the corpus (field format, encoding compatibility, and metadata preservation), followed by the application of thematic exclusion criteria.
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+Exclusion criteria
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+Once the initial corpus had been cleaned, a manual and semi-automated review of titles and abstracts was conducted using clearly defined exclusion criteria. No predefined lists of excluded keywords were established, as the focus was on preserving the field’s semantic diversity. The selection of records was carried out in two successive stages: first, a blind reading of the title and abstract; second, refinement by thematic exclusion, without the need to read the full text, given the semantic clarity of the records. According to [27], the exclusion criteria helped discriminate studies focused exclusively on: aspects of sexuality in contexts unrelated to clinical communication; economic or healthcare-cost analyses; institutional or commercial communication; and non-oncological diseases. This decision allowed us to define precise thematic frameworks to ensure epistemological consistency [12].
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+These reviews were performed using semi-automated tools implemented using Python in Google Colab, evaluating key terms in titles and thematic fields. The records were imported into EndNote, enabling efficient organization of the corpus prior to analysis in R.
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+This process was complemented by validation through a cross-check of 10–15% of the total records, which allowed for the detection of residual biases, refinement of the corpus’s thematic consistency, and greater methodological robustness [27, 38].
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+Inclusion phase
+
+The final corpus consisted of 949 documents from the Web of Science database, which served as the basis for this study.
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+Lexical curation and terminological standardization
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+After completing the document screening phase and aiming to optimize the semantic and structural quality of the corpus for bibliometric analysis, a lexical curation process was conducted to standardize terminology in the “Author Keywords” and “Title” fields. This action was not part of the document inclusion or exclusion procedure but instead responded to a subsequent analytical need: to ensure semantic consistency in the analyses of co-occurrence, n-grams, and keyword networks. The standardization of terms is an essential step to avoid conceptual dispersion in semantic maps [67]. Cobo et al. [26] recommend applying cleaning and terminological unification processes to ensure interpretative robustness in the construction of scientific networks.
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+As a preliminary step to this curation, a preliminary exploratory survey of terms in the aforementioned fields was conducted, which allowed for the identification of lexical redundancies, spelling variants, and equivalent forms (e.g., “shared decision making” vs. “shared-decision-making”), hyphenated structures, acronyms, or inconsistent pluralizations. Similar procedures have been recommended by [67] and [3], who highlight the usefulness of applying preliminary exploratory analyses as a basis for creating synonym dictionaries and terminology standardization files. Based on this survey, a synonymous file was created.
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+Techniques and metrics for data analysis
+
+R, with the Bibliometrix package and its Biblioshiny interface [3], was used as the primary tool for bibliometric analysis. These platforms enabled us to apply a set of metrics to evaluate scientific productivity, thematic dynamics, and collaboration networks. To measure the scientific productivity of authors, the total number of publications, their annual evolution, and the h [42], g [32], and m [13] indices were considered. The authorship fractionation technique [60] was also incorporated, which adjusts productivity based on the number of co-authors per article and compares total production with fractionated production.
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+In terms of the academic impact of the documents, local (within the corpus) and global (total) citations were analyzed, along with other citation indicators, which made it possible to assess the specific relevance of the publications in the area. At the relational level, term co-occurrence analysis [21] was applied and processed using the Leiden algorithm [65] to generate thematic networks and detect communities of authors. Finally, the relative position of the thematic areas was visualized using a thematic map, following the procedure described by [26].
+
+Results
+
+Scientific output in clinical communication and oncology
+
+The study focused on 949 documents indexed in the Web of Science Core Collection (WoS) between 1976 and 2025, distributed across 296 journals and with an annual growth rate of 6.79%. These indicators together characterize oncology communication as a growing but structurally uneven field. An expanding knowledge base coexists with persistent editorial dispersion and only partial integration among research communities, with consequences for the differential availability of evidence-based tools across clinical disciplines. The corpus reflects moderate international collaboration (16.33%) and an average document age of 8.52 years, indicating a relatively recent consolidation despite a time frame of approximately 5 decades.
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+The temporal evolution of the field reveals three clearly differentiated phases. The early exploratory period (1976–1999) began with the work of [50], which analyzed affective communication in patients with advanced cancer and was published in Psychosomatic Medicine. This foundational study, framed within the psychosomatic tradition, addressed the emotional dimensions of the oncological experience, anticipating contemporary approaches focused on relational care. During this stage, scientific production remained marginal, with sporadic publications, lacking thematic coherence and without sustained research programs.
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+The protocolization phase (2000–2009) marked a critical turning point. The volume of publications increased sevenfold, coinciding with the publication of the SPIKES protocol by [4] for communicating bad news. This standardization signaled a disciplinary shift from intuitive practice to evidence-based communication training. This period consolidated communication as a skill susceptible to systematic instruction, recognizing its impact on treatment adherence, emotional coping, and psychosocial distress management—outcomes that would become central to the supportive care agenda in oncology. The institutionalization of training programs, particularly visible in journals such as Patient Education and Counseling and Psycho-Oncology, laid the methodological foundations for the subsequent expansion of the field, with systematic reviews demonstrating the effectiveness of these programs [39] and the consolidation of patient communication needs as a structural axis of care [40]. The exponential expansion phase (2010–2025) shows sustained growth, with 86 publications in 2024 alone. This acceleration corresponds to the consolidation of patient-centered communication frameworks [34] and narrative medicine approaches [22], which reconceptualize communication as a therapeutic intervention rather than an auxiliary practice. The proliferation of research on quality of life [35], shared decision-making [43], and survivorship reflects a maturation toward models that integrate symptom management, psychosocial support, and caregiver communication [71] that constitute the core of supportive oncology care. At the same time, digitally mediated communication remains only weakly visible in the communication-explicit corpus, despite its increasing relevance in actual oncology care. This pattern suggests that the literature has consolidated more quickly around psychosocial, palliative, survivorship, and caregiver-related communication than around technology-mediated encounters.
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+Table 1 and Fig. 1 document these patterns, showing accumulation dynamics typical of fields transitioning from a peripheral to a semi-central position within the health sciences. The trajectory of sustained growth, together with persistent editorial dispersion, indicates a discipline advancing in consolidating its intellectual identity while managing structural tensions between progressive specialization and interdisciplinary dialogue. Table 1 Indicators of the analyzed corpus, Web of Science (1976–2025). Source: Authors (2025)
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+Indicator	Data	
+Coverage period	1976–2025	
+Total number of documents	949	
+Number of sources (journals)	296	
+Annual growth rate	6.79	
+Total number of authors	4,450	
+Single-author documents	29	
+Average number of co-authors per document	6.28	
+Percentage of international co-authorship	16.33	
+Total number of keywords (DE)	1,684	
+Total references cited	26,900	
+Average age of documents (years)	8.52	
+Average citations per document	26.59	
+
+Fig. 1 Evolution of scientific output in clinical communication and oncology. Source: Authors with data from Web of Science (2025)
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+Sources of scientific publication in clinical communication and oncology
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+The distribution of scientific output across 296 journals, with only 18 sources exceeding 10 publications (Table 2), shows a low editorial concentration (7.2%), in clear contrast to mature fields, where a higher percentage of output tends to be concentrated in a small core of central journals. Patient Education and Counseling leads the ranking with 68 documents (7.2%), followed by Supportive Care in Cancer (63) and Psycho-Oncology (57). These leading journals correspond to patient education, supportive care and psycho-oncology indicating that the field’s editorial base is distributed across the clinical domains most directly involved in managing symptoms, psychosocial needs, and quality of life throughout the cancer trajectory. The presence of the Journal of Clinical Oncology (17 publications, 1.8%) suggests that communication is visible within mainstream oncology, although it does not occupy a dominant editorial position relative to more biomedical priorities. Journals such as the Journal of Cancer Education and the European Journal of Oncology Nursing highlight the emergence of educational and nursing dimensions. In contrast, generalist platforms such as BMJ Open and PLOS ONE reflect the field’s dissemination across disciplines. Table 2 Journals with a frequency equal to or greater than 10 in the number of publications in clinical communication and oncology. Source: Authors with data from WoS (2025)
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+Journal	Number of documents	
+Patient Education and Counseling	68	
+Supportive Care in Cancer	63	
+Psycho-Oncology	57	
+Journal of Cancer Education	28	
+Journal of Palliative Medicine	19	
+Cancer	18	
+Cancer Nursing	18	
+European Journal of Cancer Care	18	
+Health Communication	17	
+Journal of Clinical Oncology	17	
+BMJ Open	16	
+Journal of Pain and Symptom Management	15	
+Journal of Health Communication	14	
+European Journal of Oncology Nursing	13	
+Palliative & Supportive Care	13	
+Pediatric Blood & Cancer	13	
+BMC Cancer	11	
+Cancers	11	
+PLOS ONE	10	
+
+By observing the evolution over time, it is possible to differentiate between established and emerging sources. Patient Education and Counseling, Supportive Care in Cancer, and Psycho-Oncology began their activities in this field before 2000, demonstrating sustained editorial commitment for more than 25 years. In contrast, later additions, such as the Journal of Cancer Education—fourth in productivity—exemplify the field’s thematic expansion beyond traditional psycho-oncological frameworks, focusing on pedagogical, training, and professional development concerns. This shift suggests a progressive institutionalization of oncological communication as a cross-cutting competence in health training, beyond its exclusive consideration as a psychosocial variable.
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+Productivity by authors
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+To provide greater clarity and a more consolidated response, productivity by author was also studied, including both published and fractionalized articles (Table 3). Table 3 Ranking of authors with more than 10 publications in clinical communication and oncology. Source: Authors using data from WoS (2025)
+
+Authors	Articles	Fractionalized articles	
+Mack, J	22	3.60	
+Tulsky, J	21	2.69	
+Bylund, C	18	2.10	
+Baker, J	16	2.29	
+Parker, P	14	2.07	
+Wittenberg, E	13	2.81	
+Banerjee, S	12	1.24	
+Shen, M	12	1.62	
+Brédart, A	11	2.40	
+Smets, E	11	1.66	
+Dolbeault, S	10	2.07	
+Henselmans, I	10	1.46	
+Pollak, K	10	1.23	
+Stiefel, F	10	2.13	
+
+Analysis of authors’ productivity allows us to distinguish between volume of production and intensity of intellectual leadership. Mack J. (22 articles, 3.60 fractional) and Tulsky J. (21 articles, 2.69 fractional) have collaboration profiles characteristic of large research groups, in which high output mainly reflects the existence of consolidated institutional infrastructures rather than the intensity of individual contributions. In contrast, authors such as Wittenberg E. (13 articles, 2.81 split) and Brédart A. (11 articles, 2.40 split) show more autonomous academic profiles, with high ratios of individual contribution, suggesting leadership in small teams or a greater orientation towards conceptual and methodological innovation.
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+Subsequently, researchers were ranked by H-index, and the analysis was completed using metrics commonly used in bibliometric studies.
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+The impact indicators (Table 4) allow us to identify three distinct types of authors. First, authors of structural relevance combine sustained productivity with a high rate of citation accumulation. Tulsky J. (h-index = 14, 1,412 citations distributed across 21 publications, with an average of 67.2 citations per document) exemplifies this profile, maintaining his influence through regular contributions to core debates in the field. Wittenberg E. also shows high productivity (index m = 0.522), indicating constant involvement for more than two decades, rather than occasional interventions of exceptional impact. Secondly, authors with high conceptual authority are identified who accumulate disproportionate volumes of citations relative to their limited output. Baile W. (9 publications, 1,587 citations, 176.3 citations per article) and Arnold R. (9 publications, 1218 citations, 135.3 citations per article) clearly represent this pattern. Their influence stems from seminal works that remain essential references decades after publication. Their relatively modest m indices should not be interpreted as low productivity, as they are, in fact, a reflection of long careers in which the impact is concentrated in paradigmatic contributions with high structural power. Thirdly, potentially emerging authors such as Smets E. (h-index = 9, m-index = 0.643, beginning publication in 2012) and Alexander S. (h-index = 8, with an average of 94.25 citations per article) stand out, showing rapid impact accumulation over relatively short periods. This pattern suggests the consolidation of new lines of research with high potential for future growth, aligned with more current topics such as patient participation, shared decision-making, and the cultural adaptation of communication models. Table 4 Ranking of the 10 authors with the most significant local impact in clinical communication and oncology according to h-index and other indicators. Source: Authors with data from WoS (2025) 
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+Author	H-index	G-index	M-index	Total citations	No. of publications	Start year	
+Tulsky J	14	21	0.667	1412	21	2005	
+Wittenberg E	12	13	0.522	288	13	2003	
+Mack J	11	22	0.55	729	22	2006	
+Baker J	10	15	0.714	248	16	2012	
+Bylund C	10	18	0.625	764	18	2010	
+Parker P	10	14	0.4	884	14	2001	
+Smets E	9	11	0.643	300	11	2012	
+Alexander S	8	8	0.4	754	8	2006	
+Arnold R	8	9	0.381	1218	9	2005	
+Baile W	8	9	0.32	1587	9	2001	
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+Intellectual structure of clinical communication in oncology
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+Looking at the co-citation structure (Fig. 2), it is clear that three coexisting paradigms structure the field’s intellectual architecture. The educational-methodological cluster (blue), articulated around Fallowfield L., Baile W., Maguire P., and Roter D., conceives communication as a trainable skill, susceptible to systematic instruction. This paradigm, consolidated through tools such as protocols and various assessment instruments, understands communication as a technical skill acquired through formal pedagogical interventions. Its central position is consistent with the institutionalization of training programs that equip oncology nurses and clinical staff with standardized tools for symptom communication, distress screening, and the delivery of complex diagnostic information. The pragmatic-clinical cluster (red), led by Back A., Tulsky J., Wright A., and Curtis J., focuses on implementing communication in highly complex clinical contexts, especially at the end of life and in palliative care. This community translates evidence into practical guidelines for palliative transitions—communicating prognosis, discussing goals of care, and managing the shift from curative to supportive treatment—competencies essential for palliative care specialists navigating complex clinical conversations. Its high internal cohesion indicates strong collaborative networks and a clear orientation toward transforming clinical practice, where communication becomes a decisive tool for shared decision-making and quality of care. The reflective-humanistic cluster (green), comprising authors such as Hagerty R., Stewart M., and Arora N., articulates biopsychosocial approaches that place the patient as an active subject in the care process, whose expectations, values, and quality of life constitute legitimate clinical outcomes. This tradition can be read as emphasizing the relational dimensions of communication that underpin survivorship care, psychosocial adaptation, and caregiver support, concerns typically addressed by psycho-oncologists and social workers within multidisciplinary teams. Its contribution broadens the field’s analytical framework to include the moral, cultural, and contextual conditions that shape the experience of illness. The network’s density suggests a significant degree of conceptual integration across these three traditions, despite their methodological diversity—with one critical exception: narrative medicine, understood as a clinical competence that enables professionals to recognize, absorb, and interpret patients’ illness narratives [22], and operationalized through methods such as reflective writing and parallel charts, remains peripheral in the co-citation network despite its theoretical recognition. That peripherality takes a different form across each of its three constitutive dimensions. Charon’s reframing of the clinical encounter—the recognition of patients’ illness narratives as clinically meaningful—registers six local citations, substantially below the 26–44 range that defines the field’s most cited works (Table 5), while the term “narrative medicine” appears in two of the 949 documents’ keyword profiles. Narrative competence as a clinical skill, and the specific methods for its development, return no traceable presence across the keyword profiles or co-occurrence structures of the corpus. The peripheral position of narrative medicine therefore takes the form not of a uniform absence but of a differential presence across its three dimensions, whose clinical and theoretical implications are examined in the Discussion.Fig. 2 Co-citation structure on clinical communication in oncology. Source: Authors based on data from WoS (2025)
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+Table 5 Ranking of the 10 articles with the most local citations in clinical communication and oncology. Source: Authors using data from WoS (2025)
+
+Article	Author(s)	Journal	Year	Local Citations	Global citations	LC/GC Ratio (%)	CT Normalized	Normalized CG	
+The communication goals and needs of cancer patients: a review	Hack T. et al	Psycho- Oncology	2005	44	301	14.62	4.60	2.59	
+Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer	Epstein R. et al	JAMA Oncology	2017	42	313	13.42	10.18	7.53	
+Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline	Gilligan T. et al	Journal of Clinical Oncology	2017	41	366	11.20	9.93	8.80	
+Approaching Difficult Communication Tasks in Oncology	Back A. et al	CA: A Cancer Journal for Clinicians	2005	36	441	8.16	3.77	3.80	
+Doctor-Patient communication and cancer patients’ quality of life and satisfaction	Ong L. et al	Patient Education and Counseling	2000	32	327	9.79	2.84	2.42	
+Breaking Bad News About Cancer: Patients’ Preferences for Communication	Parker P. et al	Journal of Clinical Oncology	2001	32	275	11.64	4.27	3.18	
+Interacting with cancer patients: the significance of physicians’ communication behavior	Arora N	Social Science & Medicine	2003	31	461	6.72	6.74	6.97	
+Oncologist Communication About Emotion During Visits With Patients With Advanced Cancer	Pollak K. et al	Journal of Clinical Oncology	2007	27	287	9.41	8.15	6.60	
+Communication Skills Training for Oncology Professionals	Kissane D. et al	Journal of Clinical Oncology	2012	27	217	12.44	10.62	6.71	
+Enhancing Communication Between Oncologists and Patients With a Computer-Based Training Program	Tulsky J. et al	Annals of Internal Medicine	2011	26	208	12.50	6.95	4.06	
+
+Analysis of documents in clinical communication and oncology
+
+The ratio of local to global citations (CL/CG) distinguishes field-specific references from works with broader cross-disciplinary influence.
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+The most locally cited works (Table 5) constitute the field’s conceptual architecture. The citation patterns reveal a field whose foundational knowledge was produced in two distinct phases—protocolization (2000–2007) and clinical implementation (2010–2017)—with post-2018 production yet to generate comparable foundational contributions.
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+Global citation patterns (Table 6) reveal a dual structure within the field’s foundational works: specialized tools with high internal impact and transferable frameworks that function as conceptual bridges for adjacent disciplines such as palliative care, medical education, and health services research. The CL/CG ratio distinguishes two functional profiles: works with high ratios (> 12%), such as Kissane et al. (12.44%) and Tulsky et al. (12.50%), serve specialized functions within the field, providing training tools and clinical protocols; works with lower ratios (< 8%), such as Back et al. (8.16%) and Arora (6.72%), operate as conceptual bridges cited across palliative care, medical education, and health services research. Table 6 Ranking of the 10 articles with the most global citations in clinical communication and oncology. Source: Authors using data from WoS (2025)
+
+Article	Author(s)	Journal	Year	Total citations	CT per year	Normalized CT	
+Health Literacy and Cancer Communication	Davis, T. et al	CA: A Cancer Journal for Clinicians	2002	483	20.13	3.29	
+Interacting with cancer patients: the significance of physicians’ communication behavior	Arora, N	Social Science & Medicine	2003	461	20.04	6.97	
+Approaching Difficult Communication Tasks in Oncology1	Back A. et al	CA: A Cancer Journal for Clinicians	2005	441	21.00	3.80	
+Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline	Gilligan, T. et al	Journal of Clinical Oncology	2017	366	40.67	8.80	
+Doctor-Patient communication and cancer patients’ quality of life and satisfaction	Ong, L. et al	Patient Education and Counseling	2000	327	12.58	2.42	
+Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer	Epstein R. et al	JAMA Oncology	2017	313	34.78	7.53	
+The communication goals and needs of cancer patients: a review	Hack T. et al	Psycho-Oncology	2005	301	14.33	2.59	
+Oncologist Communication About Emotion During Visits With Patients With Advanced Cancer	Pollak K. et al	Journal of Clinical Oncology	2007	287	15.11	6.60	
+Breaking Bad News About Cancer: Patients’ Preferences for Communication	Parker P. et al	Journal of Clinical Oncology	2001	275	11.00	3.18	
+Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial	Berry D. et al	Journal of Clinical Oncology	2011	267	17.80	5.22	
+
+Longitudinal patterns of knowledge
+
+Comparing local and global citation rankings reveal three documentary profiles: a consolidated core (Hack, Epstein, Gilligan, Parker) that functions as the field’s conceptual architecture across both metrics; specialized contributions (Kissane, Tulsky, Pollak) whose methodological tools are adopted mainly within the field and transferable frameworks (Davis, Arora) whose influence extends into medical education, health services, and health sociology. The absence of post-2018 publications from either ranking, despite representing approximately 40% of the corpus, confirms that emerging challenges such as digital communication and AI have not yet generated foundational contributions comparable to those of the 2000–2017 period.
+
+Conceptual structure of clinical communication in oncology
+
+The chronological evolution of author keywords (Fig. 3) documents a progression from generic categories to clinically operationalized constructs.Fig. 3 Annual evolution of the 10 most frequent Author Keywords in clinical communication and oncology since 1991. Bibliometrix with data from WoS (2025)
+
+The foundational term “Communication” was coined in 1991, establishing the field’s discursive anchor. Its sustained presence over more than three decades demonstrates the continuity of core concerns, while the surrounding vocabulary has transformed, expanded, and grown more complex. The appearance of “Quality of life” in 1995 reflects an ethical-clinical reorientation toward patient-centered outcomes that transcend survival metrics, especially relevant in palliative contexts. For its part, “Patient–provider communication” (1996) marks the transition from general theories of communication to relational frameworks that define the dyadic clinical encounter as the central unit of analysis. The fourteen-year gap until the incorporation of “Shared decision-making” (2005) highlights the gradual transformation from paternalistic models to deliberative approaches, consistent with broader movements toward patient empowerment and the integration of patient values into evidence-based medicine.
+
+This chronological sequence clearly illustrates the conceptual maturation of the field: from abstract constructs of communication (1991) to the relational specification of communicative processes (1996), culminating in participatory decision-making frameworks (2005). The trajectory is consistent with the theoretical evolution identified in co-citation patterns, where early psychosomatic approaches [50] gave way to communication skills training approaches (Baile & Fallowfield) and, subsequently, to patient-centered approaches [34] and narrative medicine [22]. Taken together, this progression reflects an increase in terminological complexity and a shift in the field of knowledge toward more integrative models that recognize clinical communication as a highly relevant relational, ethical, and therapeutic process.
+
+The analysis of bigram co-occurrence in titles (Fig. 4) identifies four interconnected semantic fields that structure the domain of study. The relational core (red cluster), composed of terms such as “patient–provider communication,” “breast cancer,” and “cancer patients,” functions as a structural bridge connecting clinical-demographic profiles with communicative modalities. Its centrality indicates that this nexus organizes the relationships between specific disease contexts and communication practices. However, the overrepresentation of breast cancer suggests a concentration of research attention that may reflect broader patterns in oncology research funding and advocacy rather than the communicative complexity of any single cancer type. The training-existential cluster (blue) groups terms such as “end of life,” “communication skills,” and “cancer care,” highlighting the training dimensions concentrated in high-clinical-complexity scenarios. The intense connection with the relational core reveals a remarkable thematic fluidity between general communication and the advanced stages of the disease, articulating a continuity throughout the care trajectories rather than rigid specializations. This integration suggests that end-of-life communication operates as a paradigmatic case for the development of skills, the learning of which is transferable to less acute contexts.Fig. 4 Title-Bigram co-occurrence network on clinical communication in oncology. Bibliometrix with data from WoS (2025)
+
+The preventive-predictive cluster (green), focused on “risk communication,” “prostate cancer,” “screening,” and “genetic counseling,” represents communication practices located in the early stages of the care continuum, linked to prevention, early detection, and hereditary risk. Its relative separation from the other clusters indicates limited integration between preventive and therapeutic communication, reflecting broader disconnection between public health and clinical oncology. This disconnect points to missed opportunities to develop longitudinal communication frameworks spanning from prevention to survival. Finally, the ethical-normative satellite (purple cluster), focused on “breaking bad news” and “communication preferences,” is a highly specialized subfield that addresses specific high-risk communicative acts. Its peripheral position reflects specialization around specific protocols and fundamental ethical challenges (autonomy, truthfulness, maintaining hope). The connection with the blue cluster links this specialized domain to broader training agendas, positioning the communication of bad news as an exemplary case for teaching empathic communication in oncology.
+
+Thematic map
+
+A fundamental part of responding to the third objective lies in interpreting the conceptual structures to identify areas that are underexplored or emerging for future research.
+
+To facilitate interpretation, the results are visualized using a centrality and impact map [26], where clusters of referenced documents are grouped into circles of different colors, whose sizes are adjusted according to their density. The location also allows us to attribute their structural centrality within the field, understood as their degree of connection with other subject areas, and their internal density, which indicates the level of cohesion and conceptual development of the cluster. The following image (Fig. 5) provides visual clarity for understanding the map’s uses.Fig. 5 Quadrants of the strategic diagram. Source: Authors based on [26] (2025)
+
+Next, we analyze the thematic map (Fig. 6) to identify the basic and driving themes based on their centrality and density, as well as to uncover new potential lines of research.Fig. 6 Thematic map based on Title-Bigram on clinical communication in oncology. Bibliometrix with data from WoS (2025)
+
+The driving themes (upper right quadrant) focus on patient–professional communication, cancer survivors, and health-related quality of life, forming the dynamic core of the field. Epstein and Street’s work, Patient-Centered Communication in Cancer Care [34], positions this cluster by considering clinical encounters as collaborative processes that emphasize mutual understanding and shared decision-making. [6] places Social Cognitive Theory within this framework, in which self-efficacy mediates the relationship between communication and health outcomes. Mack and Tulsky’s research on prognosis communication shows how empowering communication styles reinforce patients’ ability to manage uncertainty. Charon’s narrative medicine framework [24] also appears within this cluster.
+
+The basic themes (lower right quadrant) reveal a paradox: communication skills, systematic reviews, and pediatric oncology appear as the foundations of the field, yet lack internal cohesion. Baile, Fallowfield, Jenkins, Kissane, and Back institutionalized training programs following the consolidation of SPIKES [4] and strategies for difficult conversations [36]. [9] provided meta-analytic evidence on the effectiveness of training. [16] acts as a bridge between skills training and clinical ethics by introducing principles of narrative accompaniment, consolidating the field’s turn toward relational dimensions of care. This progression, from technical instruction to communication as a relational competence, reflects a conceptual trajectory with direct implications for how clinical teams are trained across the cancer care continuum. The location of pediatric oncology is particularly problematic, as it is classified as “basic” despite being severely underrepresented (≈ 3% of the corpus), highlighting a disconnect between its strategic importance and the attention it receives to development-specific communication challenges.
+
+Niche topics (upper left quadrant) focus on patient communication, clinical trials, and improvement initiatives, representing methodologically sophisticated intervention research but with limited integration. Hack, Pollak, Clayton, and Tulsky conduct randomized trials to evaluate the effectiveness of training, operationalizing McGuire’s [61] sequential model of persuasion through cognitive stages. [10] demonstrated this through trials with electronic self-reporting systems, while [18, 19] expanded this approach with systematic consultation preparation and training programs that showed measurable improvements. The positioning of this cluster as a niche area reflects its structural isolation from the field’s conceptual core. Methodologically rigorous experimental work on communication training remains largely self-referential, with its advances not yet generating the cross-cluster citation visibility that would indicate clinical practice penetration.
+
+To address the final research objective, four emerging thematic directions were identified in the lower left quadrant, each developing rapidly but without yet generating the citation density needed to enter the field’s conceptual core. Palliative and prognostic communication is gaining empirical grounding. [68] confirm the impact of prognostic communication on palliative clinical outcomes, [64] address its existential dimensions and [28] link goal communication with high-value care practices. Digital and technology-mediated communication accelerated during the COVID-19 pandemic. [44] document digital interventions for patient-professional communication, and [7] formalize tele-oncology protocols based on empathic competencies in technology-mediated environments. Caregiver communication is evolving toward greater structural recognition. [57] demonstrate that integrated geriatric assessment improves communication by incorporating family caregivers, [59] found that patient-caregiver communication predicts burden and preparedness for care and [45] proposed communal frameworks integrating survivors, caregivers, and professionals. Equity-informed and participatory approaches represent an emerging methodological and ethical direction. [1], [53], and [72] document racial, ethnic, and cross-cultural disparities in communication needs and practices, positioning communicative justice as a determinant of health equity. The methodological evolution toward mixed and participatory designs [51] reflects recognition that oncology communication requires methods sensitive to cultural, institutional, and relational particularities.
+
+Discussion
+
+The study reveals oncology communication as a field in transition toward consolidation. Based on the empirical indicators observed in our dataset, we characterize it as semi-peripheral, a heuristic designation supported by three convergent patterns: low editorial concentration, with no single journal accounting for more than 7.2% of output across 296 sources, limited international collaboration (16.33%) and fragmented co-citation networks, as well as a continued reliance on foundational works from the 2000–2017 period within the co-citation core. As shown in Fig. 7, the intellectual architecture is connected into the educational-methodological (Baile, Fallowfield), pragmatic-clinical (Back, Tulsky), and reflective-humanistic (Charon, Hagerty)—with the relational shift (2005–2007) the milestone that marks the transition from an instrumental transmission of information to approaches that recognize communication as a therapeutic intervention, with narrative medicine as an emerging dimension within reflective approaches. The persistence of protocols and structural gaps shapes the field’s contemporary relevance.Fig. 7 Conceptual model: Intellectual structure and research gaps in oncology communication. Source: Authors (2025)
+
+According to the work of [47], oncology communication must address challenges such as communicating diagnoses under uncertainty and discussing prognoses, among others. Furthermore, our work aligns with the findings of [8], who identified weak collaboration networks and journal dispersion, typical features of emerging specializations. In contrast to the work of [29], who documented changes in health communication over just 2 years, our work shows a gradual evolution over the 5 decades observed in oncology communication.
+
+The co-citation analysis shows the SPIKES protocol persisting as a paradigmatic example of the educational approach’s predominance. While standardized frameworks facilitate accessible training, the sustained centrality of protocols alongside the limited visibility of narrative suggests a tension between procedural emphasis and relational depth, a tension widely recognized in the general literature on health communication. Seen across its three constitutive dimensions, narrative medicine’s peripheral position acquires its specific analytical content. While Charon’s philosophical reframing of the clinical encounter circulates as a conceptual reference, neither narrative competence as a clinical skill nor the specific methods for its development appear among the field’s central keyword structures or co-citation clusters. The conceptual recognition of narrative medicine has therefore not been translated into a consolidated research line on its clinical application, leaving the dimension most directly relevant to supportive care teams—the capacity to personalize communication based on each patient’s experience of illness—without a structured evidence base within this literature. Several factors may account for this asymmetry, although they lie beyond what bibliometric data can demonstrate; we present them as interpretive hypotheses rather than empirical findings. Narrative-based research generates outputs less aligned with the publication formats favored by high-impact oncology journals, when such work is published, citation patterns may emerge more slowly, with references functioning as conceptual anchors rather than as inputs to replicable empirical chains, and also the evaluative frameworks governing evidence in oncology tend to prioritize standardized and quantifiable outcomes over interpretive depth—an asymmetry that may shape what enters the corpus as citable evidence and, downstream, what tools become available to clinicians who accompany patients through illness experience. Critical structural gaps become more urgent through comparative analysis. Digital health tools remain underrepresented in the analyzed corpus: Only thirty-one documents (3.27%) contain terms such as telemedicine, telehealth, mHealth, patient portals, or artificial intelligence in their titles or author keywords, with 25 of these published after 2020. The distribution is revealing. Established modalities, telemedicine, telehealth, patient portals, account for nearly all digital references, whereas terms associated with newer interfaces such as chatbots, video consultations, and remote consultations are entirely absent. This selective pattern suggests that the field has begun to incorporate digital platforms into its research vocabulary but has not yet engaged with the AI-mediated and synchronous modalities that are increasingly reshaping clinical encounters in post-COVID oncology care [7, 44]. The contrast with the exponential growth of AI applications in oncology documented by [73] underscores the widening distance between technological adoption in clinical practice and the communicative research traditions mapped in this study. The scarce presence of pediatric oncology (3% of the corpus), despite its particular evolutionary and family dimensions, is consistent with an adult-centric pattern in the literature. The absence of the patient’s voice as a co-researcher is consistent with broader patterns in health research, where the integration of patient perspectives into study design remains methodologically underdeveloped despite growing recognition of its value. These gaps constitute future challenges that require coordinated investment.
+
+Theoretical implications
+
+The thematic map configuration carries theoretical implications for how communication research may inform supportive care practice. The driving themes confirm that the field’s most developed research directly serves symptom-related and psychosocial communication, while the basic themes provide methodological infrastructure for training. The absence of digital, pediatric, and socio-structural domains from the consolidated thematic core suggests that the theoretical frameworks currently available to clinical teams are unevenly distributed: protocolized approaches for information delivery at diagnosis and treatment initiation are well supported in the literature, particularly for nursing and medical staff; patient-centered frameworks for prognostic and preference-sensitive decisions in palliative transitions are moderately consolidated and narrative-based approaches for the existential dimensions of survivorship and end-of-life care, where psycho-oncologists and social workers play a central role, remain the least structurally integrated. The limited thematic presence of digital communication, family-centered approaches, and socio-structural determinants indicates that these areas have not yet generated the theoretical density needed to anchor future research agendas within the field.
+
+Practical implications
+
+The structural gaps identified in this analysis point to areas where clinical teams may lack consolidated research support. Digital communication is a case in point: although oncology teams increasingly conduct tele-consultations and manage symptom reporting through patient portals, the evidence base for maintaining communication quality in these interactions remains limited [7, 44]. Similarly, the underrepresentation of pediatric oncology in the corpus suggests that clinicians working with children and adolescents may have fewer evidence-based tools adapted to developmental stages, parental roles, and sibling needs [53]. The limited presence of communication as an independent outcome variable in clinical trials means that its contribution to adherence, psychosocial adjustment, and quality of life may be underrecognized in the evidence hierarchies that inform resource allocation [35]. Finally, the scant attention to socio-structural determinants—available time, language barriers, burnout, organizational policies—indicates that the conditions enabling effective communication are less well researched than the communication skills themselves, with potential consequences for equity in under-resourced settings [1, 72]. These patterns suggest that supportive care teams—from oncology nurses managing symptom communication to palliative care specialists navigating prognosis discussions to psycho-oncologists and social workers accompanying patients through existential distress—may benefit from a more targeted research investment in the communicative dimensions of their practice.
+
+Research agenda
+
+Based on the structural gaps identified, six research directions emerge from the analysis. First, the near-absence of digital communication from the thematic core points to the need for frameworks that address communication quality in tele-consultations and remote symptom monitoring. Second, the underrepresentation of pediatric oncology suggests a priority for developing age-appropriate and family-centered communication approaches adapted to developmental stages. Third, the absence of participatory designs in the corpus indicates an opportunity to integrate patients as co-designers of communication interventions and to adopt patient-reported communicative outcomes as primary variables. Fourth, the limited attention to socio-structural determinants—time constraints, burnout, linguistic barriers, organizational policies—signals that research should address the conditions that enable effective communication, not only the skills of individual professionals. Fifth, the peripheral position of narrative medicine points to a need for institutional investment in training and evaluation that bridges the gap between its conceptual recognition and its limited presence in the field’s research core, particularly for the psycho-oncologists and social workers who work with existential distress and meaning-making in survivorship. Sixth, the placement of communication measurement within niche thematic areas suggests that consolidating communication as an independent outcome variable in clinical trials could make its contribution to adherence, quality of life, and survival more visible within the evidence base.
+
+Limitations
+
+Like any work, this study also has limitations that constrain generalizability and require interpretive caution. The restriction to the Web of Science Core Collection, while ensuring quality control through selective indexing, excludes production hosted in regional repositories (SciELO, LILACS), gray literature (clinical guidelines, institutional protocols), and professional knowledge that circulates through training and professional development networks without formal publication. The Anglo-Saxon linguistic bias inherent in WoS indexing priorities, while allowing access to mainstream knowledge, excludes translations in Spanish, French, Asian, and Global South languages, which could offer alternative conceptualizations shaped by different health systems, communication cultural norms, and specific resource contexts. The representation of digital health communication in the corpus is also shaped by the interaction between our search design and disciplinary publishing conventions. Although digital terms were included in the Topic (TS), the requirement for communication-related terms in the Title (TI), a deliberate design decision, calls for an explicit distinction between the absence of research and artefacts introduced by the search strategy, since the use of communication terms in the title might not accurately reflect communication processes in digital oncology studies. Additionally, the concentration of digital publications in the 2020–2025 period means that the most recent literature may be subject to indexing delays in Web of Science. These factors suggest that the digital underrepresentation documented in the Discussion, while substantive, should be understood as a boundary condition of the present corpus. Bibliometric methodologies capture formal citation patterns within the academic literature but, in some cases, may reflect the actual clinical impact only to a limited extent: highly cited articles may circulate mainly among researchers without influencing healthcare practice, while resources aimed at professionals that are not cited may substantially shape everyday clinical communication. These limitations necessitate complementing bibliometric findings with qualitative research focused on professionals’ perspectives, ethnographic observations of communication practices in clinical contexts, implementation studies documenting the actual adoption of protocols, and participatory approaches that place patients’ experiential knowledge at the center of analysis.
+
+Conclusions
+
+This study presents a bibliometric mapping of research on clinical communication in oncology based on 949 documents indexed in Web of Science between 1976 and 2025. The results show a field with sustained growth but with an uneven publication and citation profile. The field’s intellectual architecture, structured around three coexisting paradigms, underwent its most significant reorientation between 2005 and 2007, when communication began to be conceptualized more explicitly as a therapeutic intervention rather than merely the transmission of information. Despite this evolution, the analysis identifies significant tensions in the process of consolidating the field. An incomplete institutionalization, sustained mainly by protocolized approaches, persists despite the field’s five-decade growth trajectory. A central finding is the peripheral position of narrative medicine within the field’s intellectual structure: while Charon’s foundational work circulates as a conceptual reference, narrative competence and its associated clinical methods remain outside the field’s co-citation core, limiting the evidence available to supportive care teams for personalizing communication based on patients’ illness experiences.
+
+Thematic analysis also allows us to identify structural gaps with direct implications for the field’s future development. Digital communication is underrepresented in the analyzed corpus, despite its growing relevance in current healthcare settings. Pediatric oncology has a limited presence, which contrasts with the communicative complexity associated with specific family and developmental contexts. Added to this is the scant attention paid to the socio-structural determinants of clinical communication and the absence of the patient as a co-producer of knowledge in the predominant research designs. These findings point to a research agenda aimed at explicitly integrating digital communication and equity, developing developmentally sensitive communication frameworks in pediatric oncology, incorporating participatory methodologies, addressing the structural determinants of clinical practice, and advancing the institutionalization of narrative approaches. Taken together, these findings position clinical communication not merely as a professional skill but as a foundational infrastructure of supportive oncology care—one that spans symptom management, psychosocial screening, caregiver support, palliative transitions, and survivorship—and that requires sustained investment from multidisciplinary teams to fulfill its potential as a determinant of healthcare quality.
+
+Acknowledgements
+
+This study was conducted with financial support from the Economy, Innovation, Science, and Employment Division of the Andalusian Regional Government (Research Projects 2024-095 / PVA / I+D+I FEDER JUNTA ANDALUCIA / PR).
+
+Author contribution
+
+Conceptualization, I.T.; methodology, I.T., D.GC. and A.G.; software, I.T.; formal analysis, I.T. and D.GC.; investigation, I.T. and A.G.; data curation, I.T.; writing—original draft preparation, I.T. and A.G.; writing—review and editing, D.GC.; visualization, D.GC.; project administration, I.T. All authors reviewed the manuscript.
+
+Funding
+
+Funding for open access publishing: Universidad de Cádiz/CBUA.
+
+Data availability
+
+No datasets were generated or analysed during the current study.
+
+Declarations
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher's Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+Change history
+
+6/17/2026
+
+The correct acknowledgement should be: "This study was conducted with financial support from the Economy, Innovation, Science, and Employment Division of the Andalusian Regional Government (Research Projects 2024-095 / PVA / I+D+I FEDER JUNTA ANDALUCIA / PR)" instead of the current truncated version. The original article has been updated accordingly.
+
+
+References
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Int J Environ Res Public Health
+Journal ID: Int J Environ Res Public Health
+NLM Journal ID: 101238455
+Journal ID: ijerph
+
+International Journal of Environmental Research and Public Health
+
+ISSN: 1661-7827
+EISSN: 1660-4601
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12732687
+PMID: 41464441
+DOI: 10.3390/ijerph22121807
+Article ID: ijerph-22-01807
+Article version: 1
+Subjects: Review
+
+Global Health Governance and the WHO Pandemic Agreement: A Scoping Review of Challenges and Analysis of Reforms
+
+https://orcid.org/0009-0004-4996-4852 Abdel-Motaal Kadria Ali
+https://orcid.org/0000-0002-9689-5667 El Kheir-Mataria Wafa Abu
+https://orcid.org/0000-0002-8105-7062 Chun Sungsoo *
+Gulis Gabriel Academic Editor
+Institute of Global Health and Human Ecology, American University, New Cairo 11835, Egypt; kkmotaal@aucegypt.edu (K.A.A.-M.); wafamataria@aucegypt.edu (W.A.E.K.-M.)
+* Correspondence: sungsoo.chun@aucegypt.edu
+Electronic publication date: 2025 Nov 30
+Publication date: 2025 Dec
+Volume: 22
+Issue: 12
+Electronic Location ID: 1807
+Received 2025 Oct 15; Accepted 2025 Nov 25
+Copyright: © 2025 by the authors.
+Copyright year: 2025
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: pandemic preparedness, global health governance, WHO pandemic agreement, vaccine equity, international health regulations, treaty implementation
+
+Funding: This research received no external funding.
+
+Ÿ==============================Ÿ
+Background: The COVID-19 pandemic exposed persistent weaknesses in global health governance, particularly in preparedness, equity, and accountability. The WHO Pandemic Agreement, adopted in May 2025, aims to address these systemic gaps through a binding international framework. Objective: To identify key challenges in global pandemic preparedness and health governance reported in the literature (2019–2024) through a systematic scoping review, and to evaluate how these challenges are addressed in the provisions of the WHO Pandemic Agreement via qualitative document analysis. Methods: Using Joanna Briggs Institute methodology and PRISMA-ScR guidelines, we systematically identified and thematically analyzed 52 peer-reviewed studies published between 2020 and 2024. The thematic results informed a qualitative document analysis of the WHO Pandemic Agreement text to assess the extent to which its provisions address the identified challenges. Results: Persistent gaps in governance (limited enforceability, fragmented coordination), equity (inequitable access to medical countermeasures), capacity (technology transfer and financing), and accountability were identified. Health systems in low- and middle-income countries continue to face critical resource constraints and lack robust mechanisms to ensure accountability and continuous learning. Document analysis showed the WHO Pandemic Agreement addresses coordination and financing but offers limited advances in enforcement, technology transfer, and independent monitoring. Conclusion: The WHO Pandemic Agreement introduces important institutional and financing measures, but persistent gaps remain in enforcement, technology transfer, and inclusive implementation. Strengthening these domains is crucial to achieving equitable and resilient preparedness. By systematically linking evidence from the pandemic preparedness literature to Treaty provisions, this study offers a novel analytical framework for assessing how global health treaties respond to research-identified challenges.
+
+1. Introduction
+
+The COVID-19 pandemic exposed critical weaknesses in national health systems and revealed the shortcomings of international preparedness mechanisms, showing that individual countries cannot manage public health emergencies in isolation [1]. The Global Health Security (GHS) Index further confirmed that no country was fully prepared for such a crisis [2]. International governance mechanisms proved ineffective, as many countries adopted nationalist policies that weakened coordinated global responses, underscoring the urgent need for a unified framework to manage future health emergencies [2].
+
+Regional variability in pandemic responses highlights the need for a universal preparedness framework that can be adapted to diverse contexts [3]. While preparedness strategies have historically been reactive, there is now a shift toward proactive approaches emphasizing early intervention to prevent widespread outbreaks. However, conceptual and practical gaps remain in how preparedness is defined and operationalized [4]. The pandemic also spurred numerous initiatives to enhance international collaboration in research, surveillance, and vaccine development, including the Engineering X Pandemic Preparedness Program, the WHO’s Access to COVID-19 Tools (ACT) Accelerator, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), and the Coalition for Epidemic Preparedness Innovations (CEPI) [5,6,7]. Despite these efforts, significant shortcomings persisted, including criticisms of the WHO’s delayed response, insufficient coordination among governments, and the inability to ensure equitable access to medical countermeasures [8].
+
+As the leading global health authority, the World Health Organization (WHO) has anchored its pandemic response in the International Health Regulations (IHR), which set out member states’ obligations for managing cross-border health threats [9]. In March 2021, global leaders proposed the establishment of a new international pandemic treaty, initially envisioned as a Framework Convention to enable legally binding commitments on shared principles of preparedness, response, and equity [10]. In May 2025, the WHO Pandemic Agreement was formally adopted as a landmark step to strengthen global cooperation, equity, accountability, and resilience in future health emergencies [11].
+
+This review maps key challenges in global pandemic preparedness and governance and considers the extent to which they are acknowledged in the WHO Pandemic Agreement, with the aim of informing strategies for its effective and equitable implementation.
+
+1.1. Review Questions
+
+- What are the key challenges identified in the literature on global pandemic preparedness and global health governance?
+
+- How are these challenges addressed in the WHO Pandemic Agreement (adopted May 2025)?
+
+1.2. Objectives
+
+- To identify and synthesize key challenges in global pandemic preparedness and global health governance based on existing literature.
+
+- To examine whether, and to what extent, these challenges are addressed in the WHO Pandemic Agreement, noting strengths, omissions, and areas of limited clarity.
+
+- To propose evidence-informed recommendations to support the effective and equitable implementation of the WHO Pandemic Agreement.
+
+2. Materials and Methods
+
+2.1. Rationale and Study Design
+
+This study used a mixed qualitative design combining a scoping review and a document analysis. The aim was to identify key challenges in global pandemic preparedness and global health governance, and to examine how these challenges are addressed in the WHO Pandemic Agreement adopted on 20 May 2025. The two components are complementary: the scoping review mapped the breadth of peer-reviewed and gray literature (2019–2024) to synthesize evidence on governance challenges, while the document analysis examined how the treaty text reflects or responds to these identified issues. This dual approach follows established guidance from the Joanna Briggs Institute (JBI) and the PRISMA-ScR framework for evidence mapping, combined with accepted qualitative techniques for policy and treaty content analysis. Together, they enable triangulation between evidence-based challenges and the formal provisions of a newly adopted global legal instrument.
+
+2.2. Scoping Review
+
+Given the breadth and conceptual diversity of literature on pandemic preparedness and global health governance, the study adopted a scoping review design. Unlike systematic or narrative reviews that aim to evaluate study quality or test specific hypotheses, scoping reviews are intended to map the range and characteristics of available evidence, particularly across complex and interdisciplinary policy domains. This approach enabled comprehensive synthesis of evidence spanning legal, policy, and health systems perspectives, without restricting inclusion by study design or outcomes. Following the Joanna Briggs Institute (JBI) methodology and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, the review systematically characterized the nature and extent of available evidence to inform the subsequent document analysis of the WHO Pandemic Agreement. Consistent with PRISMA-ScR recommendations, critical appraisal and data-code availability were not undertaken, as these are optional components for scoping reviews, focused on evidence mapping rather than quality assessment (Appendix A).
+
+A broad and systematic literature search was conducted across major electronic databases: PubMed, Scopus, Web of Science, and in the academic search engine, Google Scholar. In addition, targeted searches of gray literature were performed on websites of key international organizations, including the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and United Nations (UN), to capture relevant policy documents, reports, and briefs. The search incorporated both academic and practitioner perspectives to encompass the political and governance dimensions of the topic.
+
+2.2.1. Search Strategy and Screening
+
+The search strategy was developed in accordance with JBI recommendations, combining Boolean operators, free-text keywords, and controlled vocabulary to maximize sensitivity. For example, in PubMed, Medical Subject Headings (MeSH) such as “Pandemics” [MeSH] were paired with free-text terms like “pandemic preparedness” [Title/Abstract] to capture both indexed and non-indexed records. A systematic search was then conducted across selected databases, with search strings tailored to the syntax of each. The full strategies for all databases are provided in Appendix B. For illustration, the PubMed search string was:
+
+(“pandemic preparedness” [Title/Abstract] OR “global health governance” [Title/Abstract] OR “international health regulations” [Title/Abstract] OR “pandemic treaty” [Title/Abstract] OR “pandemic agreement” [Title/Abstract]) AND (“2019/01/01” [Date—Publication]: “2024/05/01” [Date—Publication])”
+
+2.2.2. Inclusion and Exclusion Criteria
+
+This targeted approach applied inclusion and exclusion filters defined hereinafter.
+
+Inclusion Criteria
+
+Publications focusing on legal, institutional, or governance challenges related to pandemic preparedness treaties or frameworks; Analyses of global health governance mechanisms published post-2019; Peer-reviewed publications and gray literature in English, including articles, reviews, reports, policy briefs, commentaries, editorials, and other relevant formats that analyze legal, institutional, or governance aspects of pandemic preparedness.
+
+Exclusion Criteria
+
+Studies not directly addressing aspects of pandemic preparedness or international health legal instruments; Publications dated prior to 2019 (with justified exceptions); non-English language sources (due to resource constraints).
+
+2.2.3. Study Selection
+
+Three independent reviewers conducted a two-stage screening process involving title and abstract review, followed by full-text assessment of potentially eligible articles. Any disagreements were discussed among the three reviewers until a consensus was reached. The reviewers were selected for their expertise in global health governance and public health systems, as well as prior experience with review methodology, which ensured their ability to make informed and reliable decisions about article eligibility.
+
+2.2.4. Timeline
+
+The scoping review was undertaken over five months, from 1 May 2024 to 31 October 2024 and is contextualized against the subsequent adoption of the WHO Pandemic Agreement in May 2025. It is structured as follows:- Planning and protocol development: 1 month
+
+- Literature search and screening: 1.5 months
+
+- Data extraction and synthesis: 1.5 months
+
+- Reporting and manuscript preparation: 1 month
+
+2.2.5. Data Extraction and Charting
+
+Data extraction was performed using a standardized form in the Covidence platform (Covidence is a systematic review management tool designed to streamline citation screening, full-text review, data extraction, and quality assessment). Three reviewers independently screened titles and abstracts for relevance, followed by full-text reviews. Discrepancies were resolved by consensus. Two studies published prior to 2019 were retained due to their conceptual importance [12,13]. The first one was among the earliest studies to define and establish global health diplomacy as a critical, growing field linking health with foreign policy, security, and international cooperation, a key context for understanding pandemic treaty governance. The second one is a thorough analysis of the International Health Regulations (IHR), the central legal framework for global health security, essential for assessing governance and reform needs before COVID-19. The key information extracted from each publication included publication type, country, and date, thematic focus (e.g., governance, equity), and main findings related to pandemic preparedness and response. Data were organized into a standardized Excel matrix to facilitate thematic analysis and mapping of evidence.
+
+2.3. Document Analysis of the WHO Pandemic Agreement
+
+In addition to the scoping review, a focused document analysis of the WHO Pandemic Agreement (WHA78.1), adopted on 20 May 2025, was conducted. The official text, including available annexes such as the draft Pathogen Access and Benefit-Sharing (PABS) Annex, was downloaded from the WHO website on 10 June 2025 and treated as a primary policy document for qualitative content analysis.
+
+Themes generated by the scoping review served as an a priori coding framework. Two independent reviewers identified and coded treaty provisions that (i) directly addressed, (ii) partially addressed, or (iii) omitted each challenge area. Draft annexes still under negotiation at the time of analysis were coded as Pending. Consistent with established qualitative policy research standards, two independent reviewers coded treaty provisions to improve reliability and resolve subjective coding judgments. Discrepancies were discussed until consensus was reached, ensuring transparency and rigor in the mapping process. Data were summarized in a matrix mapping each literature-identified challenge to the corresponding provisions of the WHO Pandemic Agreement (WHA78.1), adopted on 20 May 2025 (Appendix C). This annex presents the results of the document analysis; cross-referencing governance challenges identified in the scoping review with specific treaty articles. Each entry indicates whether the Agreement fully addresses, partially addresses, omits, or defers (Pending) each challenge area. This mapping constitutes an integrated evidence-to-policy assessment framework, enabling systematic evaluation of how the WHO Pandemic Agreement operationalizes key governance challenges and supporting future monitoring of its implementation and accountability.
+
+This approach follows established guidance for policy and treaty content analysis ensuring transparency and methodological rigor. By aligning literature-based evidence with treaty provisions, this method enables an interpretive understanding of how the Pandemic Agreement acknowledges or responds to key governance challenges identified in the recent global health discourse.
+
+3. Results
+
+The results are organized around the four thematic domains identified through the scoping review: (1) global health governance and the WHO Pandemic Agreement, (2) vaccine equity and intellectual property barriers, (3) preparedness infrastructure and monitoring mechanisms, and (4) lessons learned from the COVID-19 pandemic. For each theme, findings from the document analysis of the WHO Pandemic Agreement are presented alongside the corresponding literature-identified challenges, illustrating how specific treaty provisions address, or fail to address, these issues. This integrated presentation demonstrates the complementarity of the two analytical phases and provides a coherent framework for evaluating the Agreement’s capacity to operationalize global health governance.
+
+3.1. Results of the Scoping Review
+
+The initial search across the four selected electronic databases and gray literature sources yielded 600 records. After the first round of duplicate removal, 311 unique records remained for title and abstract screening. During this stage, 204 records were excluded for not meeting the inclusion criteria. A further 44 duplicates, initially missed due to overlapping indexing across databases, were also identified and removed at this point. This left 63 full-text articles for eligibility assessment. Eleven studies were excluded during the data extraction phase due to thematic redundancy and limited analytical value. Finally, 52 studies met the inclusion criteria and were included in the final synthesis. The full study selection process is presented in the PRISMA-ScR flow diagram (Figure 1).
+
+3.2. Classification of the Studies
+
+The included studies were classified according to type, country focus, and year of publication to provide a contextual overview of the evidence base.
+
+The study types, including empirical research, policy analyses, conceptual papers, and reviews, are displayed in Table 1. The studies categorized by their geographical settings are displayed in Table 2. While Table 3 summarizes the temporal distribution of the studies included in this review, showing publication patterns across the years 2020–2024.
+
+3.3. Thematic Analysis
+
+An inductive thematic analysis was conducted to systematically organize and interpret the extracted data. Initially, open coding was applied to generate preliminary concepts, which informed the development of higher-order analytical categories. This was followed by focused coding to identify patterns, relationships, and recurring challenges across the literature. The analysis yielded four overarching thematic domains:Global health governance and the proposed Pandemic Treaty
+
+Vaccine equity and intellectual property barriers
+
+Preparedness infrastructure and monitoring mechanisms
+
+Lessons learned from the COVID-19 pandemic
+
+These themes provide a structured lens to examine key challenges and opportunities in advancing effective and equitable pandemic preparedness and response.
+
+3.3.1. Theme One: Global Health Governance and the WHO Pandemic Treaty
+
+This theme synthesizes findings from twenty-six studies focusing on nine interconnected subthemes that collectively address the multifaceted challenges, priorities, and reform opportunities within global health governance and how they are addressed in the new pandemic treaty (Table 4).
+
+Global Health Security and Universal Health Coverage
+
+The literature highlights a persistent structural tension between the Global Health Security (GHS) paradigm, which prioritizes the rapid containment of cross-border health threats, and the Universal Health Coverage (UHC) approach, which emphasizes sustained investment in equitable, people-centered health systems [14,15,16]. In practice, GHS often privileges surveillance, early detection, and emergency response, typically coordinated by centralized authorities. Critics argue that this security-oriented focus sidelines social determinants of health and diverts resources away from primary health care, especially in low-resource settings [15]. By contrast, UHC is anchored in principles of equity and access through health system strengthening, yet it has been critiqued as insufficiently agile in responding to acute public health emergencies when pursued in isolation from GHS [16]. The COVID-19 pandemic underscored the limitations of relying exclusively on either paradigm: countries with strong emergency response capacities but underdeveloped primary care, as well as those with robust primary care but limited preparedness systems, both struggled to maintain effective pandemic control. Scholars therefore emphasize that integrating GHS and UHC is not simply complementary but essential for developing resilient, equitable, and sustainable preparedness architectures [17].
+
+Equitable Access to Medical Countermeasures
+
+The COVID-19 pandemic underscored persistent inequities in access to medical countermeasures, particularly vaccines and antivirals, with LMICs often receiving them months after high-income countries (HICs), if at all. The COVAX initiative (COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, co-led by Gavi, the Vaccine Alliance, the World Health Organization (WHO), and the Coalition for Epidemic Preparedness Innovations (CEPI)), though intended to ensure global equity, delivered only 16% of the doses originally planned for LMICs by mid-2021, revealing deep structural limitations in voluntary international cooperation mechanisms [18]. Several studies attribute these failures to intellectual property barriers, limited local manufacturing capacity in the Global South, and the prioritization of bilateral deals by HICs that bypassed multilateral distribution platforms [18]. Without enforceable global commitments or mechanisms for redistribution, structural inequalities in pandemic response remain entrenched.
+
+Subsidiarity, Solidarity, and Decolonization in Health Governance
+
+The reviewed studies emphasize that effective pandemic governance should be grounded in the principle of subsidiarity, whereby decisions are made at the lowest level capable of addressing a given issue [19,20]. Yet, the WHO Pandemic Agreement largely reflects a top-down, state-centric orientation, with limited formal recognition of the roles of regional institutions and municipal health authorities. For example, although the Africa Center for Disease Control and Prevention (Africa CDC) demonstrated substantial capacity in coordinating cross-border responses during COVID-19, its integration into global treaty structures remains marginal. Scholars further caution that the treaty’s current framing risks reproducing unequal power relations by positioning low- and middle-income countries (LMICs) primarily as beneficiaries of aid rather than as active co-creators of governance solutions [19,20]. This dynamic is particularly salient in negotiations over the Pathogen Access and Benefit-Sharing (PABS) mechanism, where LMICs have historically contributed biological samples but received limited reciprocal benefits in the form of vaccines, diagnostics, or research outputs. Without explicitly incorporating decolonial perspectives and equity safeguards, the treaty risks undermining both legitimacy and trust, especially in regions with long-standing concerns about extractive global health practices [19].
+
+Global Health Diplomacy and Treaty Negotiations
+
+The literature underscores global health diplomacy as a vital tool for navigating competing national interests in multilateral treaty-making processes, particularly under conditions of geopolitical fragmentation [12,21,22,23]. During the COVID-19 pandemic, diplomatic mechanisms such as COVAX aimed to promote equitable vaccine distribution, yet ultimately exposed the limits of voluntary cooperation, as wealthier nations prioritized bilateral deals and vaccine stockpiling, thereby undermining the collective goals of equitable access and global solidarity [24]. Parallel analyses show that broader treaty negotiations remain constrained by sovereignty concerns, particularly among high-income countries wary of ceding decision-making authority to international bodies [25]. This tension has led to diluted language around compliance mechanisms and legal accountability, weakening the treaty’s enforceability [26]. Moreover, the persistence of “vaccine nationalism” in treaty deliberations has raised concerns about the feasibility of securing binding commitments to resource sharing during future crises. Scholars highlight the need for formalized dispute resolution mechanisms and equitable representation of LMICs in global health decision-making forums to overcome existing power asymmetries and foster durable cooperation [26].
+
+The Role and Limitations of the International Health Regulations (IHR)
+
+The IHR, developed in 2005, serves as the primary legal instrument for global health emergency coordination. However, their reliance on non-binding recommendations, lack of enforcement mechanisms, and underfunded implementation capacities have limited their effectiveness during the COVID-19 pandemic [13,27,28]. Several studies point out that during the early phases of the outbreak, delays in state reporting, the absence of standardized risk communication, and inconsistent application of travel restrictions demonstrated the IHR’s operational limitations [27]. Moreover, the WHO’s authority to verify information and issue alerts was constrained by state sovereignty and political sensitivities, which undermined the IHR’s intent to provide transparency and early detection [28]. As a result, scholars and policy analysts advocate for a new legally binding pandemic treaty that strengthens reporting obligations, includes independent verification protocols, and introduces enforcement mechanisms such as compliance monitoring or sanctions [29]. A key recommendation is the establishment of a Conference of the Parties (COP) to oversee implementation, ensure periodic review of commitments, and provide a formal structure for accountability, functions that are not currently embedded within the IHR framework [29].
+
+Deep Prevention and Multisectoral Risk Reduction
+
+The concept of deep prevention emphasizes proactive measures aimed at mitigating the root causes of pandemics, including deforestation, wildlife trade, antimicrobial resistance, and underinvestment in primary health systems [30]. Rather than focusing solely on emergency outbreak responses, this approach promotes long-term structural interventions to reduce zoonotic spillovers and environmental triggers. Reviewed studies strongly advocate for integrated, multisectoral strategies aligned with the One Health framework, which links human, animal, and environmental health systems. However, implementation remains limited due to fragmented institutional mandates, inadequate cross-sectoral coordination, and insufficient political will, particularly in low-resource settings [30].
+
+Treaty Design and Multi-Level Governance
+
+The literature underscores the importance of aligning treaty design with the realities of multilevel governance in global health, where responsibilities are distributed across local, national, and global levels. At the local level, this involves frontline service delivery and community engagement; at the national level, policymaking, resource allocation, and health system leadership; and at the global level, standard-setting, coordination, and oversight. Scholars emphasize that effective pandemic governance requires clear delineation of these roles to ensure coherence, accountability, and timely response [31].
+
+Studies highlight the risks of fragmented governance in the absence of coordination mechanisms between global, national, and sub-national authorities, especially in decentralized health systems where alignment across levels is essential [32]. In response, experts in global health law call for governance frameworks that clearly assign responsibilities across global, national, and regional levels, establish independent mechanisms to monitor compliance, and allow regional adaptation of measures while ensuring alignment with overarching global standards [31,32].
+
+Public Health Priorities for Pandemic Resilience
+
+The literature consistently highlights several core priorities for strengthening pandemic resilience, including: (i) reinforcing primary health care systems, (ii) ensuring resilient and diversified supply chains, and (iii) expanding equitable access to vaccines, diagnostics, and therapeutics [33,34,35,36]. Multisectoral coordination is emphasized as essential for aligning efforts across health, environment, and economic sectors, particularly in implementing the One Health approach [33,34]. Scholars also emphasize the need for stronger accountability mechanisms and clearly defined compliance benchmarks to assess state performance, as persistent ambiguity in reporting standards undermines effective international monitoring and enforcement [27,35,36].
+
+Future Pathways and Structural Reforms
+
+The literature proposes several structural reforms aimed at enhancing long-term pandemic preparedness and equitable access to medical countermeasures. These include establishing regional research and development hubs to diversify knowledge production, particularly in LMICs, and investing in decentralized manufacturing infrastructure to reduce dependence on high-income countries during health emergencies [37]. Additionally, researchers call for the reform of intellectual property (IP) regimes, specifically advocating for mechanisms that facilitate compulsory licensing, knowledge sharing, and technology transfer agreements to ensure broader access to life-saving tools during pandemics [37]. The failure to implement such reforms, authors warn, may perpetuate current inequalities and significantly limit the effectiveness of any global pandemic governance framework.
+
+In summary, this theme synthesizes evidence from 26 studies showing that global health governance remains characterized by structural imbalances and unresolved tensions between security-driven and equity-driven approaches. Voluntary cooperation mechanisms have proven insufficient, and gaps in intellectual property governance, benefit-sharing, and regional integration persist. Collectively, these findings point to the need for a binding, multi-layered governance instrument that clarifies responsibilities across governance levels, ensures meaningful participation of LMICs, and embeds principles such as One Health into enforceable frameworks.
+
+How Are These Challenges Addressed in the WHO Pandemic Agreement [37,38]
+
+The WHO Pandemic Agreement addresses several of the governance challenges identified in theme one, though with mixed effectiveness. It reinforces transparency and timely information-sharing by establishing binding obligations for reporting on outbreaks, public health capacities, and compliance with core requirements (Articles 3, 4, and 11). The Agreement establishes obligations for sustainable financing, including the creation of a Coordinating Financial Mechanism and the promotion of innovative financing measures through bilateral, regional, and multilateral channels, with the aim of supporting equitable access for low- and middle-income countries (Articles 13 and 18). Legal accountability is reinforced through the establishment of governance structures such as the Conference of the Parties, mandated to oversee implementation and compliance (Articles 17 and 31). In parallel, the Agreement advances multisectoral prevention by embedding the One Health approach, requiring integration across human, animal, and environmental health systems (Articles 5 and 12). However, the agreement does not explicitly empower local or regional authorities to make context-specific decisions, limiting the principle of subsidiarity and potentially reducing responsiveness at subnational levels. Furthermore, commitments to guaranteed funding remain vague, enforcement mechanisms are weak, and provisions related to intellectual property rights are underdeveloped, posing significant challenges to ensuring equitable access and effective implementation. Mechanisms for data governance and operational equity targets also lack clarity. The key components of the Pathogen Access and Benefit Sharing (PABS) Annex are still under negotiation, with finalization expected by the 2026 World Health Assembly [37,38].
+
+To summarize, the WHO Pandemic Agreement introduces significant governance innovations; however, it leaves critical gaps unaddressed. These omissions risk perpetuating inequities and governance limitations identified in the literature, suggesting that while the treaty introduces ambitious provisions, it does not fully resolve the structural and systemic challenges of global health governance.
+
+3.3.2. Theme Two: Vaccine Equity and Intellectual Property Barriers
+
+This theme synthesizes findings from six studies focusing on three interconnected subthemes: equitable vaccine distribution challenges, intellectual property barriers to vaccine technology access, and mechanisms for operationalizing equity within the WHO Pandemic Accord (Table 5).
+
+Challenges in Vaccine Distribution and Equity
+
+The COVID-19 pandemic exposed profound inequities in global vaccine allocation, as low- and middle-income countries (LMICs) experienced prolonged delays in access and substantially lower coverage compared to high-income countries. These disparities stemmed from the concentration of vaccine production capacity in high-income countries, insufficient technology transfer to LMICs, and the dominance of bilateral purchasing agreements that undermined multilateral distribution initiatives such as COVAX [39]. Although the WHO’s Immunization Agenda 2030 advocates for enhancing vaccine research, development, and production capacities in LMICs, progress remains slow due to resistance from wealthier nations over issues such as intellectual property waivers and profit-sharing [39]. Despite the efforts towards the universal acknowledgment of the moral and public health imperative for equitable access, the literature shows no consensus on the governance model necessary to implement such equity in future pandemics [39].
+
+Intellectual Property Barriers to Vaccine Technology Access
+
+Restrictive intellectual property (IP) frameworks have been identified as a central barrier to timely and equitable access to vaccine technologies in LMICs [40]. Specific obstacles included patent protections on key vaccine components, proprietary control over production methods, and the non-disclosure of manufacturing know-how, such as trade secrets, all of which constrained LMIC producers from scaling up local manufacturing during COVID-19 [40]. Although the TRIPS Agreement permits compulsory licensing as a legal flexibility, its application has been limited in practice due to procedural complexity, diplomatic opposition from high-income countries, and the risk of trade retaliation [41]. In response, some scholars propose hybrid models that combine patent protection with compulsory licensing of undisclosed technologies, seeking to balance innovation incentives with the need for rapid technology transfer and equitable access during global health emergencies [41]. Yet, these approaches have gained little traction amid geopolitical resistance and industry concerns about undermining intellectual property rights. The limited effectiveness of mechanisms such as COVAX further underscores how deficiencies in global IP governance constrained equitable vaccine distribution, pointing to the need for enforceable multilateral provisions that institutionalize technology transfer and strengthen regional manufacturing capacity [42].
+
+Operationalizing Equity in the Pandemic Accord
+
+The WHO Pandemic Agreement introduces Access and Benefit-Sharing (ABS) mechanisms aimed at linking the timely sharing of pathogens with the equitable distribution of resulting vaccines and treatments. However, multiple analyses have shown that past ABS frameworks, such as the Nagoya Protocol and the Pandemic Influenza Preparedness (PIP) Framework, have struggled to achieve meaningful equity in practice, due to vague obligations, lack of enforcement, and minimal financial returns for contributing countries [43,44]. Scholars argue that the effectiveness of the new ABS system depends on embedding enforceable mechanisms, such as automatic IP waivers for pandemic-related technologies, transparent data sharing obligations, and pre-negotiated financing for global distribution [44]. In this context, initiatives like European Union vaccine diplomacy are cited as illustrative cases that combine treaty-based principles with practical tools such as voluntary licensing, local manufacturing partnerships, and sustained capacity building support in LMICs [21].
+
+In summary, the literature converges on three persistent obstacles to vaccine equity: structural imbalances in global production, intellectual property restrictions limiting technology transfer, and the weakness of multilateral governance mechanisms. Attempts to remedy these through Access and Benefit-Sharing (ABS), technology transfer, and funding schemes remain largely aspirational. Taken together, these findings point to the urgent need for enforceable and adequately resourced global frameworks capable of addressing systemic inequities in access to medical countermeasures.
+
+How Are These Challenges Addressed in the WHO Pandemic Agreement
+
+The WHO Pandemic Agreement seeks to address critical governance challenges in vaccine equity and intellectual property, though with mixed effectiveness. It establishes a Pathogen Access and Benefit-Sharing (PABS) system to link the rapid sharing of pathogen samples and genetic sequence data with equitable access to vaccines, diagnostics, and therapeutics (Article 10, Article 18). The treaty further underscores the principle of equitable and timely access by creating a dedicated global supply system and allocation mechanism (Article 12), alongside provisions for sustainable financing to support low- and middle-income countries in scaling manufacturing and distribution capacities (Article 13) [37,38].
+
+To summarize, important constraints persist. Intellectual-property provisions rely on existing TRIPS flexibilities and voluntary licensing, with no compulsory licensing triggers or enforceable transfer of manufacturing know-how. PABS modalities (benefit types, allocation rules, trigger conditions) are deferred to future COP decisions, leaving implementation parameters unspecified. Financing obligations are not assessed or binding, and the Coordinating Financial Mechanism’s resourcing and governance are undefined. Capacity-building clauses are framed in promotional terms without quantified benchmarks or timelines, and compliance is routed through COP oversight without sanctions. Absent binding obligations on technology transfer, predictable financing, and measurable allocation targets, these provisions may be insufficient to prevent the distributional shortfalls observed during COVID-19.
+
+3.3.3. Theme Three: Preparedness Infrastructure and Monitoring Mechanisms
+
+This theme synthesizes evidence from thirteen studies addressing seven sub-themes essential to strengthening global preparedness capacity and institutional response (Table 6).
+
+Independent Monitoring and Compliance
+
+Scholars emphasized the critical role of independent monitoring in ensuring state compliance with the WHO Pandemic Treaty. They propose the establishment of an autonomous oversight body, equipped with the authority to conduct periodic assessments of national preparedness and treaty adherence. Such a mechanism is viewed as essential for transitioning the treaty from a politically negotiated text into an operational legal framework with enforceable obligations [45].
+
+Impact on Least Developed Nations (LDNs)
+
+Structural vulnerabilities, such as chronic underfunding of health systems, reliance on external supply chains, and limited negotiating capacity, continue to place LDNs at a systemic disadvantage within global health governance systems. Addressing these inequities requires treaty provisions that move beyond aspirational language, which currently relies on non-binding commitments, toward enforceable obligations. Such provisions should guarantee equitable access to medical countermeasures, safeguard national sovereignty by ensuring that LDNs retain agency in defining their health priorities and institutionalize mechanisms for sustained participation, such as guaranteed representation in COP deliberations or structured regional consultation platforms [46].
+
+Health Systems Resilience and Preparedness
+
+Studies widely recognize the importance of standardized performance indicators for assessing and strengthening health system resilience [47]. Proposed measures include: (i) the development of universal metrics, such as indicators of access, equity, and health outcomes; (ii) the integration of population health management approaches that align services with community needs through preventive care, risk stratification, and coordinated delivery; and (iii) sustained investment in health infrastructure to address inequities across income settings [33]
+
+Intellectual Property Rights and Access to Resources
+
+The rigidity of intellectual property regimes during public health emergencies is widely recognized as a major obstacle to equitable access to essential technologies [48]. Scholars advocate for legal reforms that elevate public health priorities over commercial interests, particularly in the context of global crises.
+
+Civil Society Engagement
+
+Civil society organizations (CSOs) are recognized as critical actors in translating global health policies into locally effective interventions [49]. Their participation enhances the legitimacy, cultural relevance, and community acceptance of preparedness and response strategies. Scholars emphasize that the exclusion of CSOs from decision-making processes undermines the responsiveness and equity of health systems, particularly in marginalized or high-risk communities [49].
+
+Simulation and Preparedness Exercises
+
+The operational value of simulation and preparedness exercises in strengthening pandemic readiness and system-wide coordination was emphasized [50]. These simulations serve as structured opportunities to evaluate response protocols, decision-making chains, and intersectoral communication under real-world conditions. For example, post-COVID analyses noted that countries with institutionalized simulation programs, such as Singapore and South Korea, were able to activate emergency operations faster and with fewer coordination failures [50]. Moreover, cross-border simulations have revealed recurring weaknesses in regional data-sharing and resource mobilization, underscoring the need for standardized scenario planning across jurisdictions. Scholars argue that embedding such exercises into national preparedness strategies can transform static plans into dynamic, actionable frameworks for crisis response [50].
+
+Equity and Governance in the Pandemic Treaty
+
+The literature highlights the need for a robust global governance system to ensure equitable access to vaccines, therapeutics, and diagnostics, particularly for low- and middle-income countries (LMICs) [39]. A thematic analysis of 43-member state submissions during treaty negotiations identified equity and justice as widely recognized foundational principles. However, support for adaptive governance mechanisms, such as iterative implementation, localized decision-making, and flexible oversight, was more limited, reflecting ongoing geopolitical and institutional divergence on treaty operationalization [51]. Several scholars argue that strengthening the International Health Regulations (IHR) may offer a more politically viable and expedited pathway than negotiating a new treaty, given the complexity and length of treaty processes [52,53]. This concern is reinforced by evidence that protracted negotiations risk diverting attention from urgent preparedness needs, underscoring the importance of complementary short-term and flexible governance measures [54]. At the same time, critics emphasize that treaty drafts often rely on aspirational language rather than embedding ethical principles into binding commitments with clear enforcement mechanisms [55]. The proposed Access and Benefit-Sharing (ABS) system illustrates this challenge: while conceptually promising, legal experts caution that its overlap with existing international agreements, such as the Convention on Biological Diversity and the IHR, risks creating legal ambiguities and coordination difficulties [56].
+
+In summary, the reviewed literature points to persistent structural deficiencies in global pandemic preparedness that extend beyond treaty design. Priority recommendations include creating independent compliance mechanisms to strengthen accountability, adopting standardized metrics to evaluate health system resilience, and ensuring the meaningful participation of least developed nations (LDNs) in decision-making processes. Scholars also highlight the critical role of civil society in facilitating culturally responsive, community-trusted interventions, while emphasizing the value of institutionalized simulation exercises to test preparedness strategies and decision-making under realistic conditions.
+
+How Are These Challenges Addressed in the WHO Pandemic Agreement
+
+The WHO Pandemic Agreement addresses several governance challenges through specific treaty provisions. Articles 19–22 establish a compliance mechanism under the authority of the Conference of the Parties (COP), designed to oversee implementation and promote accountability. This mechanism permits the use of state self-reporting, peer and expert assessments, and external inputs, although its operational independence and enforcement powers remain limited.
+
+Support for Least Developed Nations (LDNs) is explicitly referenced in Articles 8 and 15, which provide for targeted financial and technical assistance to strengthen health systems, expand equitable access to countermeasures, and reduce structural vulnerabilities. Article 6 further obligates states to develop and maintain core public health capacities, including essential health services, preparedness planning, and surveillance, monitored through Joint External Evaluations (JEEs) and National Action Plans for Health Security, with support from designated financial instruments.
+
+Intellectual property challenges are addressed indirectly through the ongoing negotiation of the Pathogen Access and Benefit-Sharing (PABS) system (Article 10 and draft Annex). While this system seeks to link pathogen data sharing with equitable access to vaccines, diagnostics, and therapeutics, critical issues remain unresolved, including licensing triggers, benefit-allocation rules, and enforceable technology-transfer mechanisms.
+
+Operational provisions (Articles 12, 13, and 18) include commitments to conduct simulation exercises, facilitate civil society participation, and strengthen regional manufacturing capacity. However, these clauses often lack binding obligations, concrete benchmarks, or dedicated financing guarantees, leaving implementation dependent on political will and voluntary compliance.
+
+To summarize, the Agreement makes meaningful progress by embedding compliance mechanisms, strengthening LDN participation, and mandating the development of core preparedness capacities. Yet, unresolved enforcement provisions, incomplete intellectual property reforms, and the absence of guaranteed financing weaken its capacity to deliver equity in practice. The PABS Annex remains under negotiation, creating uncertainty around benefit-sharing and access commitments. Similarly, provisions on simulation exercises and civil society engagement remain broadly aspirational, without detailed procedures or sanction-backed accountability. Unless these gaps are addressed, particularly in politically contested domains such as governance design and IP, the Agreement risks replicating the same structural inequities and coordination failures that hampered the COVID-19 response.
+
+3.3.4. Theme Four: Lessons from the COVID-19 Pandemic
+
+Seven studies explored four interconnected subthemes: Critical Gaps in Pandemic Response, missed opportunities, impacts on low- and middle-income countries (LMICs), and the role of regional collaboration. (see Table 7).
+
+Critical Gaps in Pandemic Response
+
+The literature identifies several critical deficiencies in global pandemic response systems. Key issues include delayed outbreak reporting, insufficient containment protocols, and inadequate international support for low- and middle-income countries (LMICs), particularly in terms of equitable access to diagnostics, therapeutics, and vaccines [57]. These weaknesses were further exacerbated by widespread misinformation, inconsistent enforcement of public health measures, and marked disparities in health outcomes across countries. Studies emphasize the need for resilient health systems with integrated vaccination infrastructure, strong surveillance mechanisms, and universal health care access. A recurring recommendation is the adoption of a One Health framework, which integrates human, animal, and environmental health domains to strengthen detection and response capacities [58]. Complementary lessons highlight the importance of proactive investments in public health infrastructure, strategic stockpiling of medical countermeasures, research and development, and transparent communication strategies. Together, these measures are recognized as essential components of a globally coordinated response that fosters trust, ensures timely information sharing, and enhances accountability.
+
+Missed Opportunities in Workforce and Education
+
+The review underscores a significant gap in medical and public health education, revealing that most medical curricula remain heavily centered on clinical care at the expense of training in essential public health domains, including epidemiology, health systems management, preventive medicine, and population health. Several studies argue that this narrow focus left health professionals underprepared for the system-level challenges posed by COVID-19 [59]. Key areas identified for curricular reform include the integration of disease modeling, epidemiological surveillance, triage protocols during surge capacity (i.e., guidelines for prioritizing care when resources are overwhelmed), digital health tools, and predictive analytics. These competencies are considered essential not only for pandemic preparedness but also for strengthening real-time decision-making and intersectoral coordination in future health emergencies [60].
+
+Impacts on LMICs
+
+Low and middle-income countries (LMICs) experienced a dual reality during the COVID-19 pandemic, exacerbated vulnerabilities due to limited infrastructure and funding, alongside emerging opportunities to advocate for a more equitable global health order. The literature critiques governance models that have historically treated LMICs as passive recipients of aid. Instead, scholars emphasize the need for a restructured global health architecture grounded in principles of justice, mutual trust, and shared decision-making authority. Additionally, to recognize LMICs as active agents in pandemic preparedness, to support their regional leadership, and to strengthen their capacity for research and production [61].
+
+Regional Coordination
+
+Inadequate regional coordination emerged as a major weakness in pandemic responses. In the Middle East and North Africa (MENA) region, the absence of robust collaborative mechanisms hindered both health and security outcomes [62]. In Southeast Asia, the “Association of Southeast Asian Nations, ASEAN” facilitated limited information exchange but failed to implement a unified regional response strategy. Structural barriers, including socioeconomic disparities and chronic underfunding of health systems, further undermined regional effectiveness. These gaps highlight the need for stronger multi-sectoral coordination, standardized communication protocols, and structural reforms to enhance regional preparedness and response capacities [63].
+
+In summary, the reviewed studies highlight persistent weaknesses in global pandemic response systems, including delays in outbreak detection, inconsistent implementation of public health measures, and inequitable access to medical countermeasures for LMICs. Limited integration across health, environmental, and animal sectors underscored the need for a One Health approach, while gaps in education and workforce training, particularly in epidemiological modeling and digital health, further constrained preparedness. LMICs were disproportionately affected but also emerged as advocates for equity and leadership in global governance. Finally, weak regional coordination, especially in MENA and Southeast Asia, revealed systemic barriers to collaboration, underscoring the need for stronger multisectoral and intergovernmental mechanisms.
+
+How Are These Challenges Addressed in the WHO Pandemic Agreement
+
+The WHO Pandemic Agreement incorporates lessons from COVID-19 through provisions that strengthen global and regional coordination under a multisectoral One Health framework, integrating human, animal, and environmental health surveillance and response (Articles 5, 12) [38]. It mandates timely outbreak notification and transparent data sharing to address prior delays and misinformation (Article 10) [38] and prioritizes equitable access for LMICs through financial and technical assistance, capacity-building, and system strengthening (Articles 6, 13) [38]. The agreement further promotes resilient health systems and workforce preparedness via Joint External Evaluations and National Action Plans for Health Security (Articles 6, 12) [37,38]. While education reform and workforce development are indirectly referenced through commitments to research, innovation, and health infrastructure (Article 5), the treaty does not explicitly define curricular modernization or competency standards.
+
+In summary, despite these advances, significant gaps remain. Financing provisions are framed as aspirational rather than binding (Articles 19–22), leaving sustained support uncertain. Mechanisms for regional cooperation rely heavily on political will rather than enforceable obligations, and intellectual property and benefit-sharing provisions remain under negotiation in the PABS annex. Without translating these commitments into binding, well-resourced, and operationally detailed mechanisms, the treaty risks reproducing the very inequities and implementation failures observed during COVID-19.
+
+3.4. Results of the Document Analysis
+
+The findings from the scoping review were subsequently mapped against the provisions of the WHO Pandemic Agreement (WHA78.) to assess the extent to which the treaty addresses the governance and equity challenges identified in the literature. The correspondence between literature-identified challenges and treaty provisions is summarized in Table 8 below.
+
+A detailed mapping of these linkages, including article-level analysis and degree of coverage for each theme, is provided in Appendix C.
+
+4. Discussion
+
+4.1. Situating Pandemic Governance Within a Multi-Layered Framework
+
+This discussion interprets the findings through a novel conceptual framework that organizes global pandemic preparedness into four interdependent governance layers: foundational, equity, operational, and feedback layers. These layers function as an interconnected matrix, wherein deficiencies in one dimension can cascade into vulnerabilities in others. For example, shortcomings in the foundational legal architecture, such as the non-binding nature of the International Health Regulations (IHR), can lead to institutional ambiguity, undermine operational effectiveness, and ultimately contribute to inequitable health outcomes.
+
+The foundational layer refers to the legal instruments, treaties, and institutional structures that provide the structural basis for pandemic governance. This includes frameworks such as the International Health Regulations (IHR) and the WHO Pandemic Agreement, which aim to coordinate international responses, define state obligations, and establish mechanisms for reporting and oversight. The equity layer addresses normative and distributive justice, encompassing mechanisms such as intellectual property reform, Access Benefit Sharing frameworks, and financing instruments for low- and middle-income countries. The operational layer reflects how policy is translated into action, including resilient health systems, multisectoral coordination, and preparedness simulations. Finally, the feedback learning layer emphasizes adaptive governance through continuous incorporation of lessons from past outbreaks to refine the other layers. This layered architecture moves beyond descriptive thematization to offer a systemic analytical lens. Figure 2 shows the schematic representation of the multi-layered global health governance framework, illustrating foundational health governance, operational elements of vaccine equity and pandemic preparedness, and a feedback loop for lessons learned to inform continuous improvement across all layers.
+
+4.2. Synthesis
+
+The findings from this review line up with the four layers of the conceptual framework, providing both empirical grounding and practical implications.
+
+4.2.1. Foundational Governance Layer
+
+The 57 studies reviewed, published between 2020 and 2024, reveal widespread agreement that existing legal and institutional frameworks are inadequate. Although the International Health Regulations (IHR) form the legal foundation of global health governance, they were consistently critiqued for lacking enforceability and real-time monitoring [27,28]. Scholars therefore advocate for strengthening this legal foundation through treaty-based obligations, independent oversight bodies, and robust accountability mechanisms [25,29], recognizing it as essential to enabling and sustaining pandemic preparedness.
+
+4.2.2. Equity Layer
+
+Equity constitutes the second layer of the governance framework and was a dominant concern across the reviewed literature, particularly in relation to vaccine distribution and intellectual property (IP) regimes. The failure of COVAX to deliver equitable access, achieving only a fraction of its intended vaccine allocations for low- and middle-income countries (LMICs), exposed the structural flaws of voluntary, market-dependent models [39,41]. Specifically, COVAX lacked binding procurement commitments from high-income countries and operated without enforceable obligations on manufacturers, leaving LMICs vulnerable to bilateral deals and supply delays. Intellectual property protections under the TRIPS Agreement further constrained access by limiting technology transfer and local production capabilities. In response, scholars proposed legal mechanisms such as automatic IP waivers during global health emergencies, compulsory licensing for vaccine production, technology transfer, and binding benefit-sharing obligations linked to pathogen access [40,47]. Despite their normative appeal, these proposals face strong geopolitical resistance, particularly from pharmaceutical-exporting nations. Nonetheless, these equity mechanisms are central to correcting systemic imbalances and must be structurally embedded, rather than being aspirational within future governance instruments.
+
+4.2.3. Operational Capacity Layer
+
+At the operational level, the literature reveals a fundamental tension between aspirational health governance principles and their translation into functional preparedness systems. Despite widespread endorsement of integrated strategies, particularly the convergence of Universal Health Coverage (UHC) and Global Health Security (GHS), few health governance systems adequately resolve the disconnect between long-term health system strengthening and short-term emergency response [17,43]. This gap is not merely technical but structural, reflecting deeper misalignments in policy priorities and funding mechanisms. For example, proposals to institutionalize simulation exercises and real-time surveillance are promising, yet often lack sustainable financing and political support, especially in low-resource settings. Similarly, calls to reform health education to include disease modeling, epidemiological surveillance, triage protocols, digital health tools, and predictive analytics face inertia within national curricula, despite their critical role in supporting preparedness and integrated governance [46,49]. Rather than viewing these interventions as discrete technical fixes, the operational layer must be understood as a site where equity goals and legal norms are stress-tested against logistical, institutional, and workforce constraints.
+
+4.2.4. Feedback Loop Layer
+
+The feedback layer reflects the capacity of governance systems to learn from failure and adapt in real time. Rather than relying on reactive adjustments, effective feedback mechanisms should be embedded within institutional and legal frameworks to support anticipatory action and timely course correction. Yet the literature reveals a persistent failure to institutionalize such reflexivity. The COVID-19 experience exposed not only gaps in preparedness but also the absence of structured mechanisms for transforming lessons into systemic reform. The underutilization of the subsidiarity principle illustrates this gap, although frequently cited in global governance discourse, it remains operationally vague and is often sidelined in treaty design [19,44]. Its absence reflects a broader reluctance to share rule-setting and decision-making power with local actors, which undermines both the legitimacy and responsiveness of global instruments. To address this, the feedback layer must move beyond retrospective evaluations toward dynamic learning loops that are institutionalized, inclusive, and legally anchored. Such mechanisms are vital not only for treaty adaptability but also for preserving institutional trust during future crises.
+
+In summary, the multi-layered framework advanced in this review highlights how legal, equity, operational, and adaptive mechanisms must work together for effective pandemic governance. With the WHO Pandemic Agreement formally adopted in May 2025, the analysis offers timely insights into how these governance layers can guide the implementation of the treaty. Bridging high-level principles and practical reforms, the following recommendations identify concrete pathways to strengthen treaty effectiveness and promote equitable, accountable global health systems.
+
+4.3. Recommendations and Implementation Roadmap
+
+The recommendations are structured according to the layers of the conceptual framework developed in this review. Each layer, foundational, equity, operational, and adaptive, corresponds to a specific set of actions necessary for strengthening pandemic governance.
+
+4.3.1. Foundational Governance
+
+Revising the International Health Regulations (IHR) to incorporate legally binding compliance mechanisms is essential. This includes mandatory timelines for outbreak reporting and standardized penalties for non-compliance. Furthermore, an independent compliance and monitoring body should be established under the Conference of the Parties (COP), with authority to conduct peer-reviewed audits, publish findings, and recommend corrective actions.
+
+4.3.2. Equity Mechanisms
+
+Operationalizing Access and Benefit-Sharing (ABS) systems should be directly linked to real-time epidemiological data to enable timely and equitable distribution of medical countermeasures. Intellectual property barriers could be mitigated by introducing automatic waiver and compulsory licensing provisions during declared public health emergencies, activated through predefined legal triggers. In addition, regionally distributed research and development (R&D) and manufacturing hubs in LMICs should be established, supported by formal technology transfer agreements and multi-year funding commitments, to reduce structural dependency on high-income countries.
+
+4.3.3. Operational Capacity
+
+Establish a permanent Pandemic Preparedness and Response Fund (PPRF) with needs-based disbursement criteria, prioritizing countries according to vulnerability assessments and internationally recognized preparedness metrics, such as Joint External Evaluations (JEEs) and the Global Health Security Index (GHSI). Tie funding disbursements to annual public expenditure audits and require community-level transparency mechanisms, such as digital dashboards that track fund allocation and use in real time. Invest in resilient primary health care systems that integrate Universal Health Coverage (UHC) and Global Health Security (GHS) objectives, with clear performance indicators. Expand health education to include training in data analytics, disease modeling, emergency triage, and logistics, embedded within medical and public health curricula.
+
+4.3.4. Feedback and Adaptive Governance
+
+Institutionalize the role of regional organizations, such as the Africa CDC, PAHO, and ASEAN, in treaty oversight and localized implementation, applying the principle of subsidiarity to ensure responsiveness to regional contexts. Introduce annual preparedness scorecards based on standardized indicators, including vaccination capacity, surveillance coverage, and supply chain resilience, to benchmark country performance. Require annual national implementation reports, subject to independent verification every three years by an expert review panel, with findings systematically feeding into the treaty’s Conference of the Parties (COP) to inform subsequent revision cycles.
+
+4.4. Strengths and Limitations
+
+This study has several limitations inherent to mixed qualitative designs. The scoping review component relied primarily on conceptual and normative literature, reflecting the limited empirical evidence available on global pandemic governance. Consequently, theoretical perspectives may be overrepresented compared to practice-based insights. Additionally, evidence from low- and middle-income countries (LMICs) was underrepresented, highlighting structural publication biases and resource inequities that limit global representativeness.
+
+The document analysis was conducted on the WHO Pandemic Agreement text adopted in May 2025. Key annexes, including the Pathogen Access and Benefit-Sharing (PABS) system, remain under negotiation; therefore, several provisions were coded as Pending. Furthermore, this study does not assess the implementation or effectiveness of the Agreement, which can only be evaluated once it enters into force. Future empirical research, especially incorporating LMIC and regional perspectives, will be essential to evaluate the treaty’s operationalization, financing, and accountability in practice.
+
+Despite these limitations, this study offers one of the earliest integrated analyses linking evidence from global pandemic preparedness literature with the provisions of the newly adopted WHO Pandemic Agreement. By combining a scoping review with qualitative document analysis, this study facilitates systematic triangulation between research-identified governance challenges and treaty commitments. This dual-method design provides a transparent, evidence-to-policy mapping framework and establishes a foundation for future monitoring of implementation and accountability in global health governance.
+
+5. Conclusions
+
+This study demonstrates that the WHO Pandemic Agreement, adopted in May 2025, faces critical legal, governance, and equity challenges that must be addressed for it to effectively strengthen global health security. While the treaty represents a significant advancement in international health cooperation, its success depends on the implementation of key provisions, particularly the unresolved Pathogen Access and Benefit-Sharing (PABS) mechanism, and on sustained investment in equitable and resilient health systems.
+
+By combining a scoping review of the global pandemic preparedness literature with a document analysis of the WHO Pandemic Agreement, this two-phase study bridges the gap between evidence and policy. The Multi-Layered Framework developed here highlights the interdependence between legal foundations, equity mechanisms, operational capacity, and adaptive learning as core dimensions of pandemic governance.
+
+These findings illustrate that health outcomes are shaped by the interaction of multiple global systems extending beyond the health sector, encompassing trade, diplomacy, international law, economic policy, and environmental sustainability. This raises a pivotal question: should pandemic preparedness remain confined to a health-sector governance model, or evolve toward a global governance for health approach? The latter offers a more holistic and sustainable pathway, integrating health with broader global governance systems, to achieve equity, accountability, and resilience in future pandemic responses.
+
+Author Contributions
+
+Conceptualization: K.A.A.-M. and S.C.; Design: K.A.A.-M. and S.C.; Data collection: K.A.A.-M. and S.C.; Review: K.A.A.-M., W.A.E.K.-M. and S.C.; Validation: K.A.A.-M., W.A.E.K.-M. and S.C.; Analysis: K.A.A.-M. and S.C.; Writing: K.A.A.-M. and S.C.; Editing: K.A.A.-M. and S.C.; Preparing the manuscript: K.A.A.-M. and S.C. All authors have read and agreed to the published version of the manuscript.
+
+Data Availability Statement
+
+No new data were created or analyzed in this study. Data sharing is not applicable to this article.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Appendix A. PRISMA-ScR Checklist
+
+Section	PRISMA-ScR Item	Compliance in Manuscript	
+Title	Identify the report as a scoping review.	Yes, title states ‘A Scoping Review’	
+Abstract	Structured summary including background, objectives, eligibility criteria, sources, charting methods, results, and conclusions.	Yes, Structured abstract provided with all elements.	
+Rationale	Describe rationale for the review in context of what is already known.	Yes, Introduction discusses COVID-19 governance gaps and treaty rationale.	
+Objectives	Provide explicit review questions and objectives.	Yes, Review question and objectives clearly stated.	
+Eligibility criteria	Specify characteristics of sources of evidence (e.g., publication years, languages, types).	Yes, Inclusion/exclusion criteria defined.	
+Information sources	Describe all information sources in the search (databases, registers, websites, etc.) and date last searched.	Yes, PubMed, Scopus, Web of Science, WHO, CDC, UN; searched May–Oct 2024.	
+Search	Present full electronic search strategy for at least one database.	Yes, Boolean search strings presented in Table 1.	
+Selection of sources of evidence	State the process for selecting sources (screening, eligibility, included in review).	Yes, Two-stage screening with Covidence described.	
+Data charting process	Describe methods of charting data from included sources (e.g., forms, multiple reviewers).	Yes, Standardized form in Covidence, 3 reviewers used.	
+Data items	List and define all variables for which data were sought.	Yes, Publication type, country, date, thematic focus, findings.	
+Critical appraisal of individual sources	If done, describe methods for assessing risk of bias/quality.	Not conducted, consistent with scoping review methodology.	
+Synthesis of results	Describe methods of handling and summarizing data.	Yes, Inductive thematic analysis, coding, synthesis into conceptual framework.	
+Results: Selection of sources	Report numbers screened, assessed, included, with reasons for exclusion.	Yes, Reported with flow diagram (Figure 1).	
+Results: Characteristics of sources	Present characteristics of each source of evidence.	Yes, Tables by study type, geography, year.	
+Results: Critical appraisal within sources	If done, present data on risk of bias/quality.	Not applicable in scoping review.	
+Results: Synthesis of results	Summarize and present charted results.	Yes, Organized into four themes with synthesis tables.	
+Discussion	Summarize main results, link to review objectives/questions.	Yes, Discussion maps findings to framework and treaty implications.	
+Limitations	Discuss limitations of the scoping review process.	Yes, Identified limited empirical evidence, HIC bias, timing issues.	
+Conclusions	Provide interpretation of results, implications for policy/research.	Yes, Conclusion emphasizes treaty gaps and broader governance for health.	
+Funding	Describe sources of funding and role of funders.	Yes, ‘No external funding’ statement included.	
+
+Appendix B. Search Strategy Applied for Each Database
+
+Database	Search Strategy/Query	Limits/Filters Applied	
+Web of Science (WOS)	TS = (“pandemic preparedness” OR “global health governance” OR “International Health Regulations” OR “pandemic treaty” OR “pandemic agreement”) AND PY = (2019–2024)	Publication years: 2019/2024	
+PubMed	(“pandemic preparedness” [Title/Abstract] OR “global health governance” [Title/Abstract] OR “International Health Regulations” [Title/Abstract] OR “pandemic treaty” [Title/Abstract] OR “pandemic agreement” [Title/Abstract]) AND 01/01/2019” [Date—Publication]: “01/05/2019” [Date—Publication])	Language: English; Publication date: 2019/2024	
+Scopus	TITLE-ABS-KEY (“pandemic preparedness” OR “global health governance” OR “International Health Regulations” OR “pandemic treaty” OR “pandemic agreement”) AND PUBYEAR > 2018 AND PUBYEAR < 2025	Document type: Article; Years: 2019/2024	
+WHO Global Index Medicus	“Pandemic preparedness” OR “global health governance” OR “pandemic treaty” OR “International Health Regulations”	Years: 2019/2024	
+
+Appendix C. Document Analysis Tables
+
+This annex presents the results of the document analysis of the WHO Pandemic Agreement (WHA78.1), adopted on 20 May 2025. It cross-references governance challenges identified in the scoping review with the corresponding provisions of the Agreement. Each entry summarizes how specific treaty articles address (Fully), partially address (Partially), omit (None), or defer (Pending) identified challenge areas. This mapping provides an integrated evidence-to-policy assessment framework, supporting evaluation of treaty implementation and accountability.
+
+Note: Degree of coverage: Full: (fully addressed); Partial: (addressed with limitations); None: (not addressed); Pending: (awaiting annex finalization).
+
+Appendix C.1. Theme One: Global Health Governance and the WHO Pandemic Treaty
+
+Challenge (From Literature)	Relevant Text/Excerpt in WHO Pandemic Agreement	Article Number(s)	Degree of Coverage	Notes/Gap Observations	
+Weak global coordination and fragmented governance structures	“Each Party shall cooperate and coordinate with international, regional and subregional organizations to strengthen pandemic prevention, preparedness, and response.”	Art. 3 (Purpose and Principles), Art. 4 (Scope and Relationship with Other Instruments)	Partial	Coordination language remains general; no clear mechanism for operational integration across governance levels.	
+Limited transparency and information-sharing	“Parties shall promptly share information on public health events and ensure timely reporting to WHO.”	Art. 11 (Information Sharing and Notification)	Full	Introduces binding reporting obligations and defines timeliness but lacks verification and enforcement mechanisms.	
+Insufficient sustainable financing mechanisms	“A Coordinating Financial Mechanism shall be established to mobilize predictable and sustainable resources.”	Art. 13 (Sustainable Financing), Art. 18 (Cooperation and Support)	Partial	Financing principles established, but implementation and monitoring arrangements remain vague.	
+Lack of enforceable legal accountability	“A Conference of the Parties (COP) shall oversee implementation, review progress, and promote compliance.”	Art. 17 (Implementation and Monitoring) and Art. 31 (COP)	Partial	Oversight depends on voluntary reporting; no independent compliance body or sanctions.	
+Weak integration of the One Health approach	“Parties shall adopt a One Health approach that integrates human, animal, and environmental health.”	Art. 5 (Objectives), Art. 12 (One Health and Prevention)	Partial	Framework acknowledges One Health but lacks operational standards or intersectoral funding mechanisms.	
+Limited empowerment of subnational and regional actors	—	—	None	The treaty does not explicitly include regional or local authorities, limiting subsidiarity and contextual responsiveness.	
+Unclear provisions for equitable data governance and benefit sharing	“A Pathogen Access and Benefit-Sharing (PABS) System shall be established to ensure fair and equitable sharing of benefits.”	Art. 10 (PABS System) + PABS Annex (draft)	Pending	Annex not finalized; data governance and equity metrics remain undefined.	
+Weak enforcement and compliance measures	“The COP shall adopt procedures and mechanisms to promote compliance.”	Art. 31 (COP)	Partial	No independent monitoring or sanction mechanisms; compliance largely self-reported.	
+
+Appendix C.2. Theme Two: Vaccine Equity and Intellectual Property Barriers
+
+Challenge (From Literature)	Relevant Text/Excerpt in WHO Pandemic Agreement	Article Number(s)	Degree of Coverage	Notes/Gap Observations	
+Inequitable access to vaccines and countermeasures	“Each Party shall cooperate to ensure equitable and timely access to pandemic-related products… through a global supply and allocation mechanism.”	Art. 12 (Global Supply System and Allocation Mechanism)	Partial	Establishes principle of equity but lacks measurable allocation criteria or enforcement provisions.	
+Lack of sustainable financing for manufacturing and distribution in LMICs	“Parties shall mobilize predictable and sustainable financing through bilateral, regional and multilateral mechanisms, including a Coordinating Financial Mechanism.”	Art. 13 (Financing) and Art. 18 (Cooperation and Support)	Partial	Financing is non-binding; resourcing, oversight, and timelines are undefined.	
+Limited technology transfer and manufacturing capacity	“Parties shall encourage voluntary transfer of technology and know-how to support regional production of pandemic products.”	Art. 18 (Scientific and Technical Cooperation)	Partial	Relies on voluntary mechanisms and existing TRIPS flexibilities; no compulsory licensing triggers or enforcement mechanisms.	
+Inequitable benefit-sharing for pathogen samples and genetic sequence data	“A Pathogen Access and Benefit-Sharing (PABS) System shall link access to pathogen materials and sequence data with fair and equitable benefit-sharing.”	Art. 10 (Pathogen Access and Benefit Sharing) + PABS Annex (draft)	Pending	Annex under negotiation; benefit types, allocation rules, and triggers not yet specified.	
+Weak compliance and accountability mechanisms for equity provisions	“A Conference of the Parties (COP) shall monitor implementation and promote compliance with this Agreement.”	Art. 31 (Conference of the Parties)	Partial	COP oversight depends on voluntary reporting; lacks sanctions or independent verification.	
+
+Appendix C.3. Theme Three: Preparedness Infrastructure and Monitoring Mechanisms
+
+Challenge (From Literature)	Relevant Text/Excerpt in WHO Pandemic Agreement	Article Number(s)	Degree of Coverage	Notes/Gap Observations	
+Lack of independent monitoring and compliance mechanisms	“A compliance mechanism is hereby established under the authority of the Conference of the Parties (COP) to oversee implementation and promote accountability.”	Art. 19–22 (Compliance and Oversight)	Partial	Introduces compliance framework with self-reporting and peer assessments but lacks independent enforcement powers or sanction mechanisms.	
+Structural vulnerabilities of Least Developed Nations (LDNs)	“Parties shall provide targeted financial and technical assistance to Least Developed Nations to strengthen health systems and expand equitable access to countermeasures.”	Art. 8 (Equity and Support), Art. 15 (Financial and Technical Assistance)	Partial	Explicit reference to LDNs, but mechanisms for funding delivery, monitoring, and representation in COP remain undefined.	
+Weak core health system capacities and preparedness planning	“Parties shall develop and maintain core public health capacities, including essential services, preparedness planning, and surveillance.”	Art. 6 (Core Capacities)	Full	Clear obligations aligned with IHR core capacities and JEEs, but resource dependence and uneven national implementation persist.	
+Intellectual property barriers to equitable access	“A Pathogen Access and Benefit-Sharing (PABS) System shall link pathogen data sharing with equitable access to vaccines, diagnostics, and therapeutics.”	Art. 10 (PABS System) + PABS Annex (draft)	Pending	PABS system under negotiation; lacks defined benefit types, allocation rules, and enforceable technology transfer provisions.	
+Limited operationalization of civil society participation	“Parties shall promote meaningful participation of civil society organizations and communities in pandemic preparedness and response.”	Art. 12 (Preparedness and Multisectoral Engagement)	Partial	Acknowledges CSO role but remains non-binding; lacks procedural guidelines or inclusion guarantees.	
+Weak institutionalization of simulation and preparedness exercises	“Parties shall conduct regular simulation exercises to test national and international readiness.”	Art. 12 (Preparedness and Simulation Exercises)	Partial	Provisions are aspirational without standardized implementation procedures or reporting obligations.	
+Insufficient financing and operational guarantees for equity	“Parties shall promote sustainable and predictable financing for preparedness and equitable access to countermeasures.”	Art. 13 (Sustainable Financing), Art. 18 (Cooperation and Support)	Partial	Financing clauses are general; absence of binding targets or time-bound commitments reduces enforceability.	
+Unclear mechanisms for regional manufacturing and capacity-building	“Parties shall strengthen regional manufacturing capacity for medical countermeasures.”	Art. 18 (Scientific and Technical Cooperation)	Partial	Recognizes need for regional capacity-building but relies on voluntary cooperation; no clear funding or technology-sharing mandates.	
+
+Appendix C.4. Theme Four: Lessons from the COVID-19 Pandemic
+
+Challenge (From Literature)	Relevant Text/Excerpt in WHO Pandemic Agreement	Article Number(s)	Degree of Coverage	Notes/Gap Observations	
+Critical gaps in pandemic response (delayed reporting, weak containment, misinformation)	“Parties shall ensure timely outbreak notification and transparent data sharing.”	Art. 10 (Surveillance and Data Sharing)	Full	Strengthens obligations for transparency and rapid reporting; however, operational enforcement mechanisms and penalties for non-compliance are not specified.	
+Weak integration of One Health approaches	“Parties shall adopt a multisectoral One Health framework integrating human, animal, and environmental health systems.”	Art. 5, Art. 12 (One Health and Multisectoral Coordination)	Partial	Conceptually embedded but lacks implementation guidance and measurable benchmarks.	
+Inadequate workforce education and training in public health	“Parties shall promote research, innovation, and capacity building for health systems strengthening.”	Art. 5 (Research and Innovation), Art. 6 (Health Systems Strengthening)	Partial	Indirectly addresses training through R&D and capacity-building but lacks explicit commitments to curricular reform or competency standards.	
+Structural inequities affecting LMICs	“Parties shall provide financial and technical assistance to strengthen LMIC capacities for preparedness and equitable access to countermeasures.”	Art. 6, Art. 13 (Assistance and Financing)	Partial	Recognizes LMIC support needs, but funding mechanisms are voluntary and not binding.	
+Weak regional coordination and cooperation mechanisms	“Parties shall cooperate at regional and subregional levels to strengthen preparedness and response capacities.”	Art. 12 (Regional Cooperation), Art. 18 (Technical Collaboration)	Partial	Encourages regional collaboration but lacks institutional structures or accountability frameworks for regional bodies.	
+Limited attention to misinformation and public trust	“Parties shall ensure accurate, evidence-based risk communication and counter misinformation.”	Art. 10 (Risk Communication and Transparency)	Full	Introduces explicit requirements for transparent communication, though no global monitoring system is defined.	
+
+Figure 1 Prisma Flow Diagram.
+
+Figure 2 Conceptual Framework of the Discussion.
+
+ijerph-22-01807-t001_Table 1 Table 1 Types of Studies.
+
+Categories	Document/Study Type	Count	(%)	
+Journals Articles	Commentary article	10	19.2%	
+Working Paper	3	5.8%	
+Perspective	7	13.5%	
+Editorial	4	7.7%	
+Viewpoint	13	25.0%	
+Opinion	1	1.9%	
+Letter To the Editor	1	1.9%	
+Narrative review	6	11.5%	
+Correspondence	2	3.8%	
+Scoping reviews	1	1.9%	
+Research Papers	Case study	1	1.9%	
+Background Reports	Comparative health Policy Analysis	1	1.9%	
+WHO Documents	Research Briefing	2	3.8%	
+
+ijerph-22-01807-t002_Table 2 Table 2 Geographical distribution of the studies.
+
+Country	Count	Country	Count	
+United States	9	Germany	1	
+United Kingdom	10	Hungary	1	
+Switzerland	8	Argentina	1	
+Ireland/Austria	3	Saudi Arabia/Japan/Scotland	1	
+Canada	2	India	1	
+Australia	2	Malaysia	1	
+Norway	1	Pakistan	1	
+Italy	1	China	2	
+Brazil	1	Ghana	2	
+Belgium	1	South Africa	1	
+Netherland	1	Indonesia	1	
+
+ijerph-22-01807-t003_Table 3 Table 3 Date of Publication.
+
+Year	Count	Observations	
+2020	8	This is the initial wave of publications, relatively low number due to early stages of the pandemic.	
+2021	12	Nearly doubled compared to 2020; increased efforts to understand the pandemic; and more data became available.	
+2022	7	Decrease in publications, period of consolidation, with validation of earlier research findings and focus on specific aspects of the pandemic.	
+2023	14	A new spike in publications, reaching the highest level in this timeline; as the impact of the pandemic continued, and distribution of vaccines started.	
+2024	11	Large number of publications indicating sustained interest and activity in pandemic-related research with focus on lessons learned, long-term impacts, and continued efforts to establish global health preparedness.	
+
+ijerph-22-01807-t004_Table 4 Table 4 Global Health Governance and the Proposed Pandemic Treaty Studies.
+
+Authors and Year	Focus	
+Behrendt et al., 2022 [14]	Global Health Security Doctrine (GHS)	
+Fukuda-Parr et al., 2021 [15]	Rethinking Global Health Security	
+Hosseini, 2023 [16]	Gaps in Global Health Solidarity during COVID-19	
+Lal et al., 2022 [17]	Universal Health Coverage (UHC) and Global Health Security (GHS) integration	
+Evaborhene et al., 2023 [18]	Equitable access to medical counter measures (mcm)	
+Campos-Rudinsky et al., 2024 [19]	Subsidiarity and solidarity	
+Bustamante et al., 2021 [20]	Global South Perspectives on the Pandemic Treaty	
+Chattu et al., 2024 [21]	Role of global health diplomacy in the negotiations	
+Kickbusch & Kökény, 2013 [12]	Global health diplomacy	
+Cicero & Phelan, 2024 [22]	Equity is a cornerstone for inclusive, pandemic science, where equity and science are balanced.	
+Emanuel et al., 2022 [23]	Propose an “An ethical framework for global vaccine allocation”	
+Kickbusch & Holzscheiter, 2021 [24]	Impact of geopolitical dynamics on pandemic treaty	
+Huang et al., 2024 [25]	China’s Stance on Pandemic Treaty	
+Gostin et al., 2021 [26]	A safer and equitable world during pandemics.	
+Gostin & Katz, 2016 [13]	Review IHR Performance	
+Labonté et al., 2021 [27]	“Pandemic treaty, IHR or Both?”	
+Solomon, 2022 [28]	Short-Term Negotiation Strategies for Pandemic Treaty	
+Khor & Heymann, 2021 [29]	Global health governance framework	
+Vinuales et al., 2021 [30]	“Deep Prevention,” upstream and downstream.	
+Collins et al., 2020 [31]	Public health priorities for pandemic preparedness	
+Sheerah et al., 2024 [32]	The Challenges in Developing A Pandemic Treaty	
+Faviero et al., 2022 [33]	Accountability in Pandemic Preparedness	
+Schwalbe et al., 2024 [34]	Governance Provisions in the new Pandemic Agreement	
+Gostin et al., 2023 [35]	Legal and ethical reforms to promote health and justice.	
+Hampton et al., 2023 [36]	Calls for more effective mechanisms for equitable pandemic response	
+Berman, et al., 2025 [37]	Challenges In Making the Pandemic Treaty Enforceable	
+
+ijerph-22-01807-t005_Table 5 Table 5 Vaccine Equity and Intellectual Property Rights.
+
+Author and Year	Focus	
+Bollyky TJ, et al., 2020 [39]	A framework for the equitable distribution of COVID-19 vaccines.	
+De Abreu ADJL, et al., 2023 [40]	Challenges in vaccine distribution and equity.	
+Gurgula O, 2021 [41]	Access to Vaccine Technology and Intellectual Property.	
+Horng, D.C. 2024 [42]	Vaccine Diplomacy and Equitable Access.	
+Lie R.K., et al., 2021 [43]	Balancing Global and National Responsibilities.	
+Geiger S, et al., 2024 [44]	Equitable Global Access to Health Technologies.	
+
+ijerph-22-01807-t006_Table 6 Table 6 Preparedness Infrastructure and Monitoring Mechanisms.
+
+Author and Date	Focus	
+Hanbali, 2023 [45]	Inclusion of independent monitoring in the WHO Pandemic Treaty	
+Jiang et al., 2023 [46]	Benefits and challenges of the pandemic treaty for Least Developed Nations.	
+El Bcheraoui et al., 2020 [47]	Resilience of health systems	
+Baker et al., 2022 [48]	Challenging the existing intellectual property regime	
+Baldé, 2023 [49]	Best practices of civil society engagement in the COVID-19	
+Drake, 2020 [50]	Simulation guide for enhancing pandemic preparedness.	
+Patel, 2023 [51]	Gaps in the treaty accord negotiations among the 43 member states	
+Gandhi et al., 2023 [52]	What the WHO Global Health Accord means for low-income and middle-income countries	
+Burkle et al., 2020 [53]	The roles of WHO and the International Health Regulations (IHR)	
+Frieden, et al. 2021 [54]	Would the new treaty on pandemic preparedness help or hinder current and future response efforts.	
+Schaefer et al., 2023 [55]	Ethical guidelines within the current pandemic accord.	
+Walckiers et al., 2024 [56]	Developing a treaty with an ethical and scientific foundation.	
+
+ijerph-22-01807-t007_Table 7 Table 7 Lessons from the COVID-19 Pandemic.
+
+Author and Date	Focus	
+Sachs, et al. 2022 [57]	The need for an ethical framework focusing on societal needs	
+Coccolini et al., 2021 [58]	Global experiences and lessons learned from the COVID-19 pandemic	
+Cunningham and Hopkins, 2023 [59]	To highlight the key lessons from COVID-19	
+Saqr and WASSON, 2020 [60]	Missed opportunities and the acquired lessons	
+Titanji et al., 2023 [61]	The positive lessons from the COVID-19 pandemic in low- and
+middle-income countries	
+Fawcet, 2021 [62]	Effects of COVID-19 on the Middle East and African countries	
+Djalante et al., 2020 [63]	The responses of Asian countries to the COVID-19 threat.	
+
+ijerph-22-01807-t008_Table 8 Table 8 Summary of the Correspondence Between Literature-Identified Governance Challenges and Provisions of the WHO Pandemic Agreement (WHA78.1).
+
+Thematic Domain	Key Challenge Areas
+(From Literature)	Relevant Articles in WHO Pandemic Agreement	Degree of Coverage	Summary Interpretation	
+1. Global Health Governance and the WHO Pandemic Agreement	Fragmented coordination; limited transparency; weak legal accountability; insufficient sustainable financing; poor integration of One Health; weak enforcement and regional inclusion	Arts. 3–5, 10–13, 17–18, 31 (+draft PABS Annex, as it still under negotiation).	Partial	Strengthens coordination, financing, and One Health principles, but lacks enforceable accountability, subnational inclusion, and clear compliance mechanisms.	
+2. Vaccine Equity and Intellectual Property Barriers	Inequitable access to countermeasures; insufficient financing for LMICs; limited technology transfer; weak IP and benefit-sharing mechanisms	Arts. 10, 12–13, 18, 31 (+draft PABS Annex)	Partial/Pending	Advances equity goals via global supply and financing systems but relies on voluntary IP waivers and technology transfer; key PABS modalities remain unresolved.	
+3. Preparedness Infrastructure and Monitoring Mechanisms	Gaps in compliance and monitoring; limited support for LDNs; weak simulation exercises; under-institutionalized civil-society participation; inadequate financing	Arts. 6, 8, 12–13, 15, 18–22 (+draft PABS Annex)	Partial	Introduces a compliance mechanism and LDN assistance. However, monitoring lacks independence and financing commitments remain aspirational.	
+4. Lessons from the COVID-19 Pandemic	Delayed reporting; misinformation; weak regional cooperation; inequities in LMIC support; insufficient workforce training and education	Arts. 5–6, 10, 12–13, 18–22 (+draft PABS Annex)	Partial/Full in selected areas)	Improves early-warning and data-sharing duties and embeds One Health; however, education, regional collaboration, and financing provisions lack binding force.	
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+References
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+62. Fawcett L. The Middle East and COVID-19: Time for collective action Glob. Health 2021 17 133 10.1186/s12992-021-00786-1 PMC8607409 34809646
+63. Djalante R. Nurhidayah L. Van Minh H. Phuong N.T.N. Mahendradhata Y. Trias A. Lassa J. Miller M.A. COVID-19 and ASEAN responses: Comparative policy analysis Prog. Disaster Sci. 2020 8 100129 10.1016/j.pdisas.2020.100129 34173447 PMC7577870
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+Publisher: BMJ Publishing Group
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+DOI: 10.1136/bmjopen-2026-119558
+Article ID: bmjopen-2026-119558
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+Subjects: Protocol, Oncology, 1717, 1506
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+Supporting adherence to adjuvant CDK4/6 inhibitors in women with early breast cancer (SWEET-PLUS): protocol for a multicentre UK study using qualitative and co-development methods
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+https://orcid.org/0009-0001-9552-4995 Teow Pearlin 1
+https://orcid.org/0000-0002-9226-5115 McGeagh Lucy 2
+Cain Henry 3
+https://orcid.org/0000-0003-1496-9341 Todd Adam 4
+Rehman Farah 5
+https://orcid.org/0000-0002-5116-4238 Brett Jo 2
+Levitt Nicky 6
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+Hunt Emma 6
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+https://orcid.org/0000-0002-3592-1315 Watson Eila 2 0
+https://orcid.org/0000-0001-9515-1722 Sharp Linda 1 0
+1 Population Health Sciences Institute , Newcastle University , Newcastle upon Tyne , UK
+2 Oxford Institute of Applied Health Research , Oxford Brookes University , Oxford , UK
+3 Newcastle Upon Tyne Hospitals NHS Foundation Trust , Newcastle upon Tyne , UK
+4 School of Pharmacy , Newcastle University , Newcastle upon Tyne , UK
+5 Imperial College Healthcare NHS Trust , London , UK
+6 Oxford University Hospitals NHS Foundation Trust , Oxford , UK
+7 Research Software Engineering , Newcastle University , Newcastle upon Tyne , UK
+8 School of Psychology , University of Surrey , Guildford , UK
+Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
+
+HC has received honorarium for speaking and advisory boards from Pfizer, Novartis and Lilly. EW has received honorarium for speaking and support for meeting attendance from Novartis. LS has received support for meeting attendance from Novartis. All other authors declare no conflict of interest.
+
+Professor Linda Sharp; Linda.Sharp@newcastle.ac.ukEW and LS are joint senior authors.
+
+Publication date: 2026
+Electronic publication date: 2026 Aug 11
+Volume: 16
+Issue: 8
+Electronic Location ID: e119558
+Received 2026 Mar 12; Accepted 2026 Jul 10
+Copyright: Copyright © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.
+Copyright year: 2026
+License: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Cancer, Medication Adherence, QUALITATIVE RESEARCH, Self-Management, Patient-Centered Care
+
+Funding: http://dx.doi.org/10.13039/501100009128 Research for Patient Benefit Programme NIHR207952
+
+The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
+
+Ÿ==============================Ÿ
+Abstract
+
+Introduction
+
+Breast cancer is the most common cancer in women in the UK. For women who have early-stage oestrogen-receptor positive (ER+ve) disease, daily oral adjuvant endocrine therapy reduces risk of recurrence. Recently, CDK4/6 inhibitors, a form of biological therapy, have been approved for use alongside endocrine therapy. However, trial data suggest there may be challenges with adherence to CDK4/6 inhibitors. This study aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer. It will also co-develop an intervention to support women with adherence to these drugs alongside endocrine therapy through an evidence-based, theory-informed and patient-centred approach.
+
+Methods and analysis
+
+The SWEET-PLUS study has three phases. Phase I uses semi-structured interviews or focus groups to explore the experiences of women with early breast cancer who have been prescribed CDK4/6 inhibitors. It will also explore their support needs and experiences of adherence. Phase II involves interviews or focus groups with healthcare professionals who support CDK4/6 inhibitor prescription and associated care to understand the existing support and unmet needs. Phase I and II findings will inform phase III, which comprises workshops and user testing interviews to co-develop an intervention to support women with adherence to CDK4/6 inhibitors alongside endocrine therapy. This will be delivered as an additional module prototype designed for future integration into the existing HT&Me intervention, which supports women with adherence to endocrine therapy.
+
+Data from phases I and II will be analysed using a framework approach-based thematic analysis. Phase III data will be analysed through content analysis.
+
+Ethics and dissemination
+
+SWEET-PLUS received ethical approval from the National Health Services (NHS) Health Research Authority (Cambridge East Research Ethics Committee (25/EE/0220)). Research findings will be disseminated through peer-reviewed journal articles and via international and national conferences. Further dissemination will be guided by patient and public involvement.
+
+STRENGTHS AND LIMITATIONS OF THIS STUDY
+
+Usage of a theory-informed framework that emphasises a no-blame approach towards medication adherence will enable comprehensive identification of the support needs of women on CDK4/6 inhibitors for early breast cancer.
+
+Recruitment through National Health Service sites and supplementary avenues such as social media, charities and support groups will create opportunities to engage with harder to reach populations, including those who have poorer breast cancer outcomes.
+
+Continual patient and public involvement throughout each phase will ensure that the study and the proposed intervention remain patient-centred.
+
+The developed prototype add-on module will be evidence-based, theory-informed, patient-centred and specifically designed for future integration into the existing HT&Me intervention, which is feasible and acceptable to women with breast cancer and health professionals for supporting adherence to endocrine therapy in women with early breast cancer.
+
+Participant recruitment will be restricted to women who choose to participate in the study and are able to speak and understand English due to funding limits.
+
+Introduction
+
+In the UK, almost 57 000 new breast cancers are diagnosed annually, and 11 200 women die from breast cancer.1 Most women are diagnosed at an early stage; 85% have stage I or II disease, which has not spread beyond local lymph nodes,2 and 7.5% have stage III disease,1 where the cancer has spread locally but not to distant organs. Breast cancer prognosis has improved since the 1990s,3 and survival rates for early-stage breast cancer are high. The 5-year net survival rate is 98.4, 90.3 and 75.6% for stage I, II and III disease, respectively.4 However, breast cancer can recur after surgery, radiotherapy and/or chemotherapy. Recurrence risk is highest for the initial years post-diagnosis but persists for more than 30 years.5 Approximately 80% of breast cancers are oestrogen sensitive (ER+ve).1 This means that the presence of oestrogen can stimulate the growth, or re-growth, of cancerous cells. Research has shown that up to 20% of ER+ve early breast cancers recur within 10 years.5 In addition, one-third of patients with stage 2 disease and one half of those with stage 3 will eventually recur.6 Among women and their families, fear of recurrence is a major unmet need.7
+
+Women with early ER+ve disease are recommended daily adjuvant oral endocrine therapy for 5–10 years to reduce risks of recurrence and breast cancer death.6 Endocrine therapy works by blocking the effect of oestrogen or lowering the amount of oestrogen present in the body. The choice of medication (eg, tamoxifen or aromatase inhibitors such as letrozole, anastrozole and exemestane) is influenced by menopausal status, risk of recurrence and patient preferences.8 While endocrine therapies have been available for almost 50 years,9 there have been significant advances in pharmacological approaches to cancer treatment in the last decade. These approaches often target specific pathways of cancer pathogenesis (biological or precision therapies) or use the body’s immune system to target the cancer (immunotherapies). Until recently, these treatments were limited to advanced or metastatic cancer. However, in 2022, the National Institute for Health and Care Excellence (NICE) in England recommended a biological therapy—the CDK4/6 inhibitor abemaciclib—alongside adjuvant endocrine therapy in a subset of early ER+ve patients with breast cancer with higher recurrence risk (see table 1).10 In trials, abemaciclib tablets taken two times per day for 2 years (alongside endocrine therapy) reduced recurrence by 34% vs endocrine therapy alone.11 Another CDK4/6 inhibitor—ribociclib—has been found to benefit an even larger patient group (ER+ve, HER2-ve, stage 2/3, node negative/positive).12 Ribociclib has been under consideration by NICE for use in the early breast cancer setting and was given preliminary approval in April 2025.13
+
+Table 1 Summary of features for the use of abemaciclib and ribociclib alongside endocrine therapy in the early-stage adjuvant breast cancer setting
+
+Feature	Abemaciclib (TA810)	Ribociclib (TA1086)	
+Indication	Adjuvant with endocrine therapy	Adjuvant with aromatase inhibitor	
+Endocrine partner	Tamoxifen or aromatase inhibitor	Aromatase inhibitor (± ovarian suppression)	
+Subtype	HR positive, HER2 negative	HR positive, HER2 negative	
+Stage	Early breast cancer	Early breast cancer	
+Risk group	High risk (restricted)	High risk (broader)	
+Nodal status requirement	Node-positive only	Node-positive and some node-negative	
+Definition of high risk as per trial	≥4 nodes OR 1–3 nodes+tumour ≥5 cm or grade 3	Node-positive: ≥4 nodes OR 1–3 nodes + (≥5 cm OR grade 3)	
+No nodes, but adverse tumour biology/size>5 cm OR 2–5 cm + (grade 3 OR high Ki‑67/genomic risk)	
+Schedule type	Continuous	Cyclical	
+To be taken	Two times per day	Taken once a day for 3 weeks on/1 week off	
+Duration of use	2 years	3 years	
+HR, hormone receptor.
+
+However, non-adherence to CDK4/6 inhibitors (ie, intentional or unintentional failure to follow the recommended treatment regimen because of, for example, not starting the medication, deviating from the dosing schedule by skipping doses or taking reduced doses or stopping treatment early) may be a significant problem.14–16 In the adjuvant early-disease setting, 26% of trial participants discontinued abemaciclib, for reasons other than recurrence, before completing the recommended 2-year treatment.17 For ribociclib, only ~40% of trial participants completed the 3-year course.12 Since trial populations are often selected (ie, more homogeneous and less comorbid than the general clinical population with the condition), motivated and well supported, it seems very likely that adherence to CDK4/6 inhibitors could be even lower in the real-world setting of routine clinical practice.18 19 This phenomenon was observed in relation to adherence to endocrine therapy in breast cancer and many other medications.20
+
+Medication non-adherence, while modifiable, is a complex behaviour with multiple determinants.21 A recent umbrella review of determinants of endocrine therapy non-adherence highlighted the influence of a wide range of inter-related factors.22 These include medication factors (eg, complexity of treatment regimen, side effects), patient-related factors (eg, available family/social support, beliefs about the cancer and medication) and healthcare system-related factors (eg, patient–professional relationship, follow-up care). Due to the contemporary nature of abemaciclib and ribociclib usage in the early breast cancer setting, there is lack of knowledge surrounding the determinants of CDK4/6 inhibitors non-adherence when used alongside endocrine therapy.
+
+In recent years, there has been burgeoning interest in the development of interventions to support adherence to endocrine therapy.23 With the anticipated rapid uptake of CDK4/6 inhibitors alongside endocrine therapy,24 25 there is a pressing need for endocrine adherence-based interventions to incorporate CDK4/6 inhibitors into their design. This would ensure interventions adequately address any new or shifting support needs that may arise from the inclusion of CDK4/6 inhibitors alongside endocrine therapy.
+
+We recently designed an evidence-based, theory informed, patient-centred self-management intervention—HT&Me—to support endocrine therapy adherence among women with ER+ve early breast cancer.26 HT&Me was developed within the SWEET (Improving Outcomes for Women diagnosed with early breast cancer through adherence to adjuvant endocrine therapy) research programme (https://www.sweetstudy.co.uk). It comprises (1) a short animation; (2) two personalised nurse/practitioner consultations (in-person or online); (3) an interactive web-app and (4) regular email or text reminders. It has been shown to be acceptable to women and healthcare professionals, and feasible to be delivered within the UK National Health Service; a large trial of effectiveness and cost-effectiveness is currently underway.26–28 The availability of HT&Me provides a foundation for the implementation of adherence support for CDK4/6 inhibitors in this same population.
+
+Aims and objectives
+
+Aim
+
+SWEET-PLUS aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer and to use these insights to inform the co-development of a prototype add-on module to the HT&Me intervention (online supplemental material A) to support women adhere to these drugs alongside endocrine therapy.
+
+Objectives
+
+The objectives of SWEET-PLUS are to:
+
+Explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer (phase I)
+
+Investigate healthcare professionals’ experiences of prescribing CDK4/6 inhibitors in early breast cancer and providing associated follow-up care and views on patient support and unmet needs (phase II)
+
+Co-develop, with patients, a prototype additional module for HT&Me to support women with adherence to CDK4/6 inhibitors (alongside endocrine therapy) (phase III)
+
+Methods and analysis
+
+Study status
+
+SWEET-PLUS started on 1 August 2025 and obtained ethical approval on 20 October 2025. Phase I interviews started on 10 November 2025, Phase II interviews started on 6 January 2026. Phase I and II data collection is anticipated to end late summer 2026. All data collection is anticipated to end on 31 January 2027.
+
+Study design
+
+The SWEET-PLUS study will adopt a qualitative approach incorporating semi-structured interviews, focus groups, online co-development workshops and user-testing interviews. The study has three phases. Phases I and II will run in parallel followed by phase III. The co-developed add-on module prototype will undergo user-testing and serve as an addition to the existing HT&Me intervention as part of the SWEET programme. Figure 1 provides an overview of SWEET-PLUS and its relationship with the SWEET programme.
+
+Figure 1 Overview of SWEET-PLUS and its relationship with the SWEET programme. CBT, cognitive behavioural therapy; GUIDED, GUIDance for the rEporting of intervention Development checklist; MRC, Medical Research Council; NHS, National Health Service; TIDieR, Template for Intervention Description and Replication.
+
+Theoretical framework
+
+The Perceptions and Practicalities Approach (PaPA) will provide theoretical underpinnings for the study. The use of a theoretical framework can enable a comprehensive perspective through the integration of complex personal and contextual factors into the process of intervention development.29 30 Following the NICE Medicines Adherence Guidelines,31 PaPA adopts a ‘no-blame’ approach towards medicine non-adherence and suggests that support should be tailored to address specific perceptions (eg, beliefs about treatment and condition) and practicalities (eg, capabilities and resources) influencing motivation and ability to continue treatment.32 It specifies adherence support must take account of the patient’s evaluation of treatment necessity and concerns. PaPA was used in the development of HT&Me to support endocrine therapy adherence.26–28
+
+Interviews and focus groups (phases I and II) will draw on elements of PaPA and related models, including Leventhal’s Common Sense Model of Illness and the Necessity/Concerns Framework.33 34
+
+Similar to the SWEET programme, SWEET-PLUS will follow MRC and INDEX guidance35 36 on intervention development, underpinned by the Person-Based Approach,37 to ensure that we prioritise and incorporate user perspectives where possible during the co-development process.
+
+Phase I
+
+Phase I of the research will involve qualitative interviews and/or focus groups. These will explore experiences of adherence to CDK4/6 inhibitors and identify support needs among women with early-stage ER+ve breast cancer.
+
+Eligibility and sampling
+
+We will interview women with stage 1–3 ER+ve breast cancer who have been prescribed a CDK 4/6 inhibitor alongside endocrine therapy within the past 18 months; eligibility criteria are summarised in table 2. We will include women who remain on a CDK4/6 inhibitor (irrespective of whether they have had a dose reduction), those with suboptimal implementation (eg, skipping doses, dose reduction), those who have discontinued (e.g personal choice, stopped on clinical advice) and those who have finished treatment. From experience, we anticipate that approximately 25 (and a maximum of 30) interviews will be needed to reach reasonable theoretical sufficiency (conceptual depth)38 regarding women’s CDK4/6 inhibitor experiences. The anticipated sample size also aligns with Malterud’s39 concept of information power, as SWEET-PLUS has clear research aims, is rooted in established theories and has a specifically niche target population.
+
+Table 2 Eligibility criteria for participants in phases I and III
+
+Inclusion	Exclusion	
+Women (over 18, no upper age limit) who have early-stage oestrogen sensitive breast cancer and have been prescribed a CDK 4/6 inhibitor alongside endocrine therapy within the past 18 months.	Male patients with breast cancer	
+Women who remain on a CDK4/6 inhibitor (irrespective of whether they have had a dose reduction), those with suboptimal implementation (eg, skipping doses, dose reduction) and those who have discontinued. They will also be eligible irrespective of whether they had access to a CDK4/6 inhibitor within routine care or as part of a randomised controlled trial.	Women who were initially diagnosed with metastatic breast cancer	
+Women must have capacity to give informed consent, as judged (where relevant) by their clinical care team.	Women who would need a translator to participate in the study	
+
+To ensure that the voices of women from groups with poorer breast cancer outcomes are captured (eg, Black women and those resident in more deprived areas), we will draw on the Centre for Ethnic Health Toolkit40 and the INCLUDE ethnicity framework,41 and purposively sample potentially eligible patients for ethnic and socio-economic diversity and set quotas (eg, 5–8 Black women and 5–8 women who live in the four most deprived IMD deciles in our sample of ~25). Diversity in other characteristics (eg, age group, CDK4/6 inhibitor drug, other breast cancer treatments) will also be sought across the sample.
+
+Recruitment
+
+Participants will be recruited through two approaches: NHS hospital sites (primary recruitment route) and non-site routes (supplementary recruitment route).
+
+The three NHS sites are The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, Imperial College NHS Trust and Oxford University Hospitals NHS Trust. To attract women from under-represented backgrounds and communities to participate in the study, we will implement suggestions from our SWEET-PLUS Patient Advisory Group (PAG). We will also work with the research delivery teams at each site to support them to implement the sampling quotas. Strategies to be adopted will include (1) emphasising the importance of diversity in Site Initiation Visits; (2) monitoring recruitment diversity and intervening if necessary; (3) offering practical support around recruitment (eg, providing delivery teams with a look-up table listing postcodes of more deprived areas in the site’s catchment area for use in screening patients for eligibility); (4) signposting delivery staff towards training resources (eg, cultural competency) if they wish to develop their skills in this area and (5) sharing ‘good practice’ (ie, strategies that have worked) across sites.
+
+Supplementary recruitment (non-site) will be conducted through breast cancer support groups and charities with whom we already have close links and social media (eg, Facebook support groups for women on abemaciclib/ribociclib). In our approaches through these networks, we will make it clear that we would like to involve women from different backgrounds. Those interested in taking part will be invited to contact the study team by email, phone or text. Interested individuals will be screened to help ensure diversity. If required, supplementary recruitment will also be conducted via the NIHR’s Be Part of Research Portal (https://bepartofresearch.nihr.ac.uk/).
+
+If required to maximise diversity, we will also use snowball sampling approaches and ask participants to nominate others who fit the eligibility criteria from their networks.
+
+Data collection
+
+To ensure inclusive research practice,41 42 interviews or focus groups with patients will be conducted by telephone, video call or, if the individual strongly prefers (and study resources permit), in person. Additionally, they will be scheduled at a time that suits the participant (eg, avoiding working hours or when they have caring responsibilities) and interviewees will be offered a £25 shopping voucher as recompense for their time.
+
+Interviews and focus groups will follow a semi-structured topic guide (online supplemental material B) informed by past research, team experience and theory (ie, PaPA). Interviews or focus groups will cover experiences of being offered a CDK4/6 inhibitor (including information provision, knowledge and understanding, beliefs about treatment necessity, concerns about the medication and its effects); experiences of taking the medication (including managing it alongside endocrine therapy and any other drugs, side effects, support offered or received with adherence or side effects, dose reductions) and experiences of follow-up care (including regular hospital visits, satisfaction with care) and any unmet needs (eg, information, psychological well-being). The guide will be used flexibly and evolve as the interviews or focus groups progress to ensure that any new issues raised are explored to sufficient depth in subsequent interviews or focus groups.
+
+The same topic guide will be used to inform interview and focus groups, though in the focus groups there will, inevitably, be less opportunity to probe and develop points of discussion. In an attempt to maximise data quality and depth from the focus groups, we have created a code of conduct for participants emphasising the importance of anonymity and confidentiality (online supplemental material C). This will help contribute to a safe environment within which participants can speak freely. Participants will also be sent a follow-up email in case they wish to share any further experiences or follow-up ideas on a 1-to-1 basis. This will provide an opportunity to discuss any personal experiences or disclosures that they might not be comfortable sharing in a group setting.
+
+Participants will also be asked whether they would be willing to be (re-)contacted to participate in later phases of the study (ie, phase III).
+
+Phase II
+
+Phase II will use a cross-sectional qualitative approach to explore healthcare professionals’ (HCPs’) experience of prescribing or supporting women using CDK4/6 inhibitors alongside endocrine therapy for the management of early breast cancer. We will also explore HCPs’ perceptions of support needs for patients on CDK4/6 inhibitors. This will involve focus groups or interviews, with relevant HCPs involved in prescribing CDK4/6 inhibitors for early breast cancer and/or providing follow-up care.
+
+Eligibility and sampling
+
+Eligible HCPs will include (but will not be limited to) oncologists, surgeons, cancer nurse specialists, clinical pharmacists and chemotherapy nurses. We will seek diversity among participants in specialty/professional role and years of experience or seniority.
+
+Based on experience, to reach reasonable data sufficiency in relation to participants’ experiences of CDK4/6 inhibitors in early breast cancer, we anticipate recruiting approximately 20 (and up to a maximum of 25) participants. If required, we will run more groups or recruit more interviewees to ensure data sufficiency.
+
+Recruitment
+
+We will recruit HCPs primarily from the same three NHS hospitals as in phase I, working through the site PIs initially and then through the process of snowballing.
+
+To supplement recruitment, we will (1) advertise the study through Breast Cancer Now’s health professional network which includes 2100 health professionals with an interest in breast cancer and/or (2) conduct focus groups alongside relevant conferences (eg, Association of Breast Surgeons, UK Oncology Nursing Society). We may also recruit through the professional networks of the study team, including Cancer Alliances. These supplementary recruitment routes will provide further diversity of HCP experiences.
+
+Data collection
+
+Data collection will primarily be through interviews with HCP. We will also offer the option of focus groups (eg, involving two HCP from the same site).
+
+Focus groups or interviews will follow a semi-structured topic guide (online supplemental material D). Topics will include experiences of CDK4/6 inhibitors in early breast cancer; whether/how HCPs advise women about dose reductions and (dis-)continuation; whether/how HCPs judge medication risks and benefits for individual patients; how monitoring for toxicity is undertaken; barriers and facilitators to using the drugs in practice and maintaining adherence; and views on additional support needed. The guide will be used flexibly across focus groups or interviews with new issues raised added to the guide for subsequent focus groups or interviews.
+
+Focus groups or interviews will take place online using Microsoft Teams. They will be scheduled in alignment with HCPs’ schedules. We will seek to run separate groups for medics/consultants and other health professionals so that open discussion is not impeded by professional hierarchies.
+
+Coding and analysis for phases I and II
+
+Interviews or focus groups will be recorded, transcribed and a framework approach-based thematic analysis will be undertaken.43 To develop the analytical framework, the core team (authors PT, LM, EW, LS) will review and discuss the codes for the first two transcripts, ensuring at least two people review each one. Using the framework, one person (PT) will complete coding and analysis, discussing regularly with the core team. Approaches to maintain rigour will be applied (eg, constant comparison, deviant case analysis).44 A second stage of analysis will deductively map codes to the elements of PaPA and the supportive care needs framework.45 NVivo will be used to support data management.
+
+Preparations for intervention co-development
+
+Before commencing phase III, findings from phases I and II will be triangulated46 to inform the content of the intervention prototype (ie, add-on module to HT&Me). This may include information about how the medication works, the importance of adherence, strategies to support taking it as prescribed, information on key side effects and potential ways to manage these.
+
+An up-to-date review of the literature on CDK4/6 inhibitors in the adjuvant setting will also be undertaken to ensure that information content is evidence-based where relevant. Drawing on Cochrane guidance for rapid literature reviews,47 we will specify a tightly focused research question(s) (eg, medication efficacy, risks of toxicity) using the PICO framework. We will work with a medical librarian to develop an efficient search strategy (combining key words and MeSH headings) and search up to three key databases (eg, EMBASE, Medline, CINAHL). Consideration will be restricted to full papers published in English within a defined time frame (eg, since 1 January 2020), reflecting the introduction of CDK4/6 inhibitors in early breast cancer. Screening will be undertaken by a single reviewer, with 10% of citations independently double-screened. Data extraction from relevant studies will be focused and conducted by a single reviewer. A descriptive summary of included studies will be constructed, and narrative synthesis undertaken separately for each research question, if relevant. The review protocol will be made publicly available. Breast cancer clinicians will be on hand to advise throughout, including on interpretation of the evidence.
+
+Phase III
+
+Phase III will involve working in partnership with patients with breast cancer to co-develop the intervention content. This will be followed by iterative refinement through user testing. The co-developed and tested content will serve as a prototyped add-on module for the SWEET intervention HT&Me. The existing structure and style of HT&Me will determine some of the design decisions.
+
+Co-development workshops
+
+We will conduct at least two online workshops to iteratively co-develop intervention content.
+
+Each workshop will have a different group of 5–8 patient participants (ie, women with breast cancer with experience of adjuvant CDK4/6 inhibitors; eligibility criteria as per phase I). Workshop 1 will include women from the PAG, as they have familiarity with the project and objectives and its relationship to the SWEET programme. Workshop 2 will include a mix of women who were interviewed in phase I (and who indicated a willingness to help with later stages of the work) and women who have not previously participated. New participants will be recruited through our three collaborating NHS hospitals (and, if needed, through supplementary non-site routes) with a focus on ensuring diversity. If additional workshops are required to discuss elements of the design or content, recruitment will proceed as for workshop 2.
+
+At workshop 1, we will co-develop an animation storyboard, proposed animation images and draft a script together with participants. Similar to the HT&Me animation,26 the co-developed animation will provide information about CDK4/6 inhibitors and address common concerns. This will be followed by discussions about the content participants would like to see in the web-app module. Workshop participants will be provided with access to the HT&Me web-app before the workshop to help inform these discussions. Following the workshop, we will work with the animation company to incorporate feedback and finalise the animation.
+
+Prior to workshop 2, we will work with research software developers to build wire frames (blueprints) of key pages for the web-app. Alongside this, we will develop draft content for the web-app and other relevant content. In designing the web-app and developing content, we will use our learnings from the development of the SWEET programme and expertise of our research software engineer colleagues to ensure that the web-app is easy to access, navigate and uses clear lay language. For intervention content, we will take care to integrate diverse lived experiences (eg, using diverse images of women, quotes from women from different areas, ethnic groups and ages, and review by our diverse PAG) and enhance inclusive design practice.
+
+At workshop 2, the web-app content and wire frames will be reviewed and feedback from participants will be sought. This will be followed by a review of other relevant content. Following the workshops, the prototype will be refined, and the prototype web-app module will be built with the incorporation of the participants’ feedback from the workshop. Similar to phase I, participants in the workshops will receive a £25 shopping voucher as recompense for their time.
+
+User testing
+
+Iterative user testing of the prototype intervention will involve think-aloud interviews with women in the intervention target population.48 A maximum variation sample of women naïve to the intervention design will be recruited; this will comprise a mix of women interviewed in phase I who indicated that they would be willing to be recontacted (and who have not participated in workshop 2) and new recruits. As in phase I, we will work through collaborating hospitals and other non-site routes to ensure ethnic and socio-economic diversity among these new recruits.
+
+Interviewees will view the prototyped animation and web-app module with a researcher present and be invited to say what they are thinking out loud. These interviews will be online using video-conferencing software (unless the participant strongly prefers an in-person interview); we successfully undertook user testing in this way for HT&Me.26 They will provide detailed, immediate, observable reactions and inform changes to design and content.
+
+Approximately 10 women will be interviewed in total, in rounds of approximately five (ie, interviews, analysis, refinement, repeat). Interviews will be audio-recorded, transcribed and content analysis conducted. Criteria will be developed for deciding on modifications (eg, likely to impact on adherence, acceptability) and modifications prioritised using the MoSCoW (Must have, Should have, Could have, Would have) criteria.49 Pre-testing will cease when no major new issues or concerns are raised in interviews (ie, more than 10 women may be recruited).
+
+Anticipated outcome
+
+The developed content will serve as a prototype for the add-on module to our existing HT&Me intervention. It will be documented following the TIDieR checklist49 with intervention context categorised using the Behavioural Change Taxonomy.50 A logic model for change will be developed, aligned where appropriate with the logic model for the HT&Me intervention.26–28
+
+Further funding will be sought to test the feasibility and acceptability of the prototype alongside the implementation workstream in our SWEET research programme. Following this, any final changes will be made, and the module will be incorporated into HT&Me.
+
+Ethics and dissemination
+
+A favourable opinion has been granted from Health Research Authority, Cambridge East Research Ethics Committee (25/EE/0220).
+
+Consent
+
+Informed consent will be sought before the start of each research encounter. If the interview is taking place remotely, consent will be audio-recorded; the researcher will take the individual through the verbal consent form, and the researcher will sign at the end. Each focus group, co-development and user-testing participant will be consented in the same way before the start of the research encounter. The recordings of consent will constitute a separate record to the interview recording, to enable the separation of personal data and study data. The participant will also be able to ask any further questions they wish at this point of contact with the researcher. Importantly, participants will be informed that their participation is entirely voluntary and that they may withdraw at any time without a reason or any negative consequences.
+
+Ethical considerations
+
+It is possible that patients participating in qualitative research may have emotional consequences as the interviews may involve them considering and discussing potentially upsetting issues related to their breast cancer. If an interviewee does not wish to answer any question during the interview, this will be respected. This is made clear on the participant information sheet and will be reiterated at the start of the research process. If they become upset, the researcher will ask them if they wish to halt the interview, either temporarily or permanently. If they become very distressed, the researcher will ask whether they would like her to contact someone (eg, family member, friend, GP, consultant, breast cancer nurse) on their behalf. In addition, if taking part in the study has raised questions for the participants about their breast cancer, they will be advised to contact their breast cancer consultant or nurse specialist. Participants with breast cancer will be provided with a debrief sheet, which will also provide signposting to avenues of support.
+
+Dissemination
+
+The main outputs of the SWEET-PLUS study will be a detailed understanding of (1) the views and experiences of women prescribed CDK4/6 inhibitors (alongside endocrine therapy) for the treatment of early breast cancer and (2) the practices and views of healthcare professionals involved in supporting women on this treatment, leading to (3) the development of an intervention (co-developed with patients) for a prototype ‘add-on module’ to an existing intervention (HT&Me) to support women with adherence to these biological therapies.
+
+Findings will be disseminated via publications in peer-reviewed journals, conference presentations and shared with relevant organisations (eg, UK Breast Cancer Clinical Studies Group, Breast Cancer Now charity). To promote dissemination to patients and lay audiences, our SWEET-PLUS PAG will help us produce lay summaries of the findings which we will host on our study website. We will also enlist the help of members from the SWEET-PLUS PAG and the SWEET Programme PAG with dissemination across their patient networks.
+
+Patient and public involvement
+
+Women with breast cancer and lived experience of taking CDK4/6 inhibitors have been integral to the development of the study. This has included the establishment of a SWEET-PLUS PAG. PAG members (six women, aged 35–50 with experience of CDK4/6 inhibitors alongside adjuvant endocrine therapy) have reviewed the research questions, grant applications, patient participation information sheets and the phase I interview schedule. The study will continue to be guided by the PAG who will be involved throughout, advising on all phases. This will include activities such as supporting recruitment by identifying and helping address barriers; reviewing and commenting on findings from phases I and II; reviewing the HT&Me website to start identifying core aspects that could be added to support those taking CDK4/6 inhibitors in advance of phase III; assisting with strategies for dissemination of key findings to achieve maximum impact (eg, lay summaries and infographics), etc. Additionally, PAG members will also participate in the first co-development workshop which will start to develop the prototype intervention as part of phase III. Continual engagement with the PAG will ensure the research remains firmly patient-centred and is conducted in a manner that is sensitive and aligned to patients’ needs and experience.
+
+Discussion
+
+Over the past two decades, there has been an explosion in the availability of oral anticancer drugs, especially costly immunological, biological and precision therapies. Until recently, these were licensed only for use in metastatic disease. In recent years, the approval of CDK4/6 inhibitors (abemaciclib and ribociclib) in the early breast cancer adjuvant setting has led to an increasingly rapid uptake of these medications within the NHS.24 25 However, trial data and clinical experience suggest there is significant non-adherence to these drugs,51 with many women discontinuing these drugs prematurely. Although some services recognise the challenges of adherence and are seeking to try to address these (eg through monitoring or starting women on lower doses (Chaytor, personal communication, 2025)) as far as we are aware, there are no formal programmes designed to support women with self-management and adherence to these drugs alongside endocrine therapy. SWEET-PLUS will therefore fill an important evidence-gap.
+
+While determinants of non-adherence to abemaciclib and ribociclib are unknown, evidence points to some potentially relevant factors. Treatment regimens for CDK4/6 inhibitors can be complex. Abemaciclib is taken orally in tablet form two times per day and women return to the hospital regularly (every 2 weeks initially, then monthly for a few months) for toxicity monitoring. Ribociclib is taken daily on a 3 weeks on/1 week off cycle, with regular hospital visits (and ECGs) to monitor toxicities. Our related research among patients using biological and precision medicines in advanced cancer highlights the highly stressful nature of regular hospital monitoring.52 In addition, multiple side effects can occur with CDK4/6 inhibitors. Up to 20% of patients on abemaciclib may experience diarrhoea, nausea, headaches, infections, anaemia, leucopenia, neutropenia, hepatotoxicity and/or fatigue.6 53 Severe diarrhoea, the most common side effect, may be managed with regular loperamide use, and nausea, for which anti-emetics may be helpful. A small proportion of patients experience severe reactions, including pneumonitis or venous thromboembolism.54 The most common ribociclib side effects are neutropenia, hepatotoxicity, QT prolongation, joint pain, nausea and headache.55 There is a 42% increased risk of venous thromboembolism.56 Some severe adverse effects can lead to hospitalisations; others are manageable via dose reductions,57 58 but the extent to which dose reductions, or other forms of support, are offered is unknown. As CDK4/6 inhibitors are routinely rolled out within the NHS, the SWEET-PLUS study is well-timed to address this pressing knowledge gap.
+
+Supplementary material
+
+10.1136/bmjopen-2026-119558 online supplemental file 1
+
+10.1136/bmjopen-2026-119558 online supplemental file 2
+
+10.1136/bmjopen-2026-119558 online supplemental file 3
+
+10.1136/bmjopen-2026-119558 online supplemental file 4
+
+Acknowledgements
+
+The authors would like to thank the patient representatives and members of our Patient Advisory Group for their generosity and time in sharing their expertise and providing feedback at various points of the study.
+
+Data availability statement
+
+No data are available.
+
+Review Process File
+
+Electronic publication date: 2026 Aug 11
+
+Funding: This project is funded by the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (NIHR207952).
+
+Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2026-119558).
+
+Provenance and peer review: Not commissioned; externally peer reviewed.
+
+Patient consent for publication: Not applicable.
+
+Data availability free text: Data sharing is not applicable at this stage as this manuscript describes a study protocol, and we are still in the process of data collection. Upon completion of the study, de-identified data will be made available in accordance with institutional policies, participant consent, and ethical approvals.
+
+Patient and public involvement: Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
+
+Ethics approval: A favourable opinion has been granted from Health Research Authority, Cambridge East Research Ethics Committee (25/EE/0220).
+
+
+References
+
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+18 Haji M Shah Z Yu H et al Real-world analysis of adjuvant abemaciclib in high-risk HR+/HER2− early breast cancer J Clin Oncol 2026 44 e12529 10.1200/JCO.2026.44.16_suppl.e12529
+19 Thorpe CT Gairola R Real-world patterns of dose reduction and early discontinuation of abemaciclib for early-stage, hormone-receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer in insured United States adults J Clin Oncol 2026 44 e12718 10.1200/JCO.2026.44.16_suppl.e12718
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+21 Peh KQE Kwan YH Goh H et al An Adaptable Framework for Factors Contributing to Medication Adherence: Results from a Systematic Review of 102 Conceptual Frameworks J Gen Intern Med 2021 36 2784 95 10.1007/s11606-021-06648-1 33660211 PMC8390603
+22 Todd A Waldron C McGeagh L et al Identifying determinants of adherence to adjuvant endocrine therapy following breast cancer: A systematic review of reviews Cancer Med 2024 13 e6937 10.1002/cam4.6937 38240343 PMC10905548
+23 Bright EE Finkelstein LB Nealis MS et al A Systematic Review and Meta-Analysis of Interventions to Promote Adjuvant Endocrine Therapy Adherence Among Breast Cancer Survivors J Clin Oncol 2023 41 4548 61 10.1200/JCO.23.00697 37531593 PMC10553065
+24 National Institute for Health and Care Excellence [NICE] Resource impact report: abemaciclib with endocrine therapy for adjuvant treatment of hormone receptorpositive, HER2-negative, node-positive early breast cancer at high risk of recurrence [ta810] 2022 Available https://www.nice.org.uk/guidance/ta810/resources/resource-impact-report-pdf-11139447853 40498889
+25 National Institute for Health and Care Excellence [NICE] Resource impact summary report: ribociclib with an aromatase inhibitor for adjuvant treatment of hormone receptor-positive HER2-negative early breast cancer at high risk of recurrence, ta1086 2025 Available https://www.nice.org.uk/guidance/ta1086/resources/resource-impact-summary-report-pdf-19989645768133 40982614
+26 Stewart S-J Slodkowska-Barabasz J McGeagh L et al Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life The Breast 2023 70 32 40 10.1016/j.breast.2023.05.007 37300986 PMC10382955
+27 McGeagh L Walker A Hiller L et al Improving outcomeS for Women diagnosed with early breast cancer through adhErence to adjuvant Endocrine Therapy (SWEET): study protocol for a pragmatic randomised control trial of a patient-centred intervention to improve adherence to endocrine therapy in early breast cancer Trials 2025 26 551 10.1186/s13063-025-09056-6 41299751 PMC12659038
+28 McGeagh L Stewart S-J Norris R et al Supporting women with adherence to adjuvant endocrine therapy (SWEET): feasibility study of the HT&Me intervention Eur J Oncol Nurs 2026 80 103026 10.1016/j.ejon.2025.103026 41421217
+29 Chair SY Huang Z Fan MSN et al The Effect of Theory-Guided Positive Psychological Interventions for Patients With Breast Cancer: A Systematic Review and Meta-Analysis J Clin Nurs 2026 35 33 46 10.1111/jocn.70025 40626621 PMC12667006
+30 Stewart SJF Moon Z Horne R Medication nonadherence: health impact, prevalence, correlates and interventions Psychology & Health 2023 38 726 65 10.1080/08870446.2022.2144923 36448201
+31 National Institute for Health and Care Excellence [NICE] Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence, clinical guidance, cg76 NICE 2009 Available https://www.nice.org.uk/guidance/cg76 39480983
+32 Horne R Cooper V Wileman V et al Supporting adherence to medicines for long-term conditions: A perceptions and practicalities approach based on an extended common-sense model Eur Psychol 2019 82 96 10.1027/1016-9040/a000353
+33 Leventhal H Phillips LA Burns E The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management J Behav Med 2016 39 935 46 10.1007/s10865-016-9782-2 27515801
+34 Horne R Chapman SCE Parham R et al Understanding patients’ adherence-related beliefs about medicines prescribed for long-term conditions: a meta-analytic review of the Necessity-Concerns Framework PLoS One 2013 8 e80633 10.1371/journal.pone.0080633 24312488 PMC3846635
+35 Skivington K Matthews L Simpson SA et al Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update Health Technol Assess 2021 25 1 132 10.3310/hta25570 PMC7614019 34590577
+36 O’Cathain A Croot L Duncan E et al Guidance on how to develop complex interventions to improve health and healthcare BMJ Open 2019 9 e029954 10.1136/bmjopen-2019-029954 PMC6701588 31420394
+37 Yardley L Morrison L Bradbury K et al The person-based approach to intervention development: application to digital health-related behavior change interventions J Med Internet Res 2015 17 e30 10.2196/jmir.4055 25639757 PMC4327440
+38 Braun V Clarke V To saturate or not to saturate? Questioning data saturation as a useful concept for thematic analysis and sample-size rationales Qualitative Research in Sport, Exercise and Health 2021 13 201 16 10.1080/2159676X.2019.1704846
+39 Malterud K Siersma VD Guassora AD Sample Size in Qualitative Interview Studies: Guided by Information Power Qual Health Res 2016 26 1753 60 10.1177/1049732315617444 26613970
+40 Centre for Ethnic Health Research Increasing participation of black, Asian and minority ethnic groups in health and social care research toolkit Centre for Ethnic Health Research 2022 Available https://ethnichealthresearch.org.uk/research/resources-2/increasing-diversity-in-research-2/increasing-participation-of-black-asian-and-minority-ethnic-groups-in-health-and-social-care-research/ 10.1186/s12874-021-01489-2 PMC8758375 35026996
+41 Improving inclusion of under-served groups in clinical research: guidance from the NIHR-include project National Institute for Health Research [NIHR] 2024 Available www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435
+42 Bamidele OO E. McGarvey H Lagan BM et al “Hard to reach, but not out of reach”: Barriers and facilitators to recruiting Black African and Black Caribbean men with prostate cancer and their partners into qualitative research Eur J Cancer Care 2019 e12977 10.1111/ecc.12977 30548713
+43 Gale NK Heath G Cameron E et al Using the framework method for the analysis of qualitative data in multi-disciplinary health research BMC Med Res Methodol 2013 13 117 10.1186/1471-2288-13-117 24047204 PMC3848812
+44 Rapley T Sampling strategies in qualitative research Flick U The SAGE Handbook of Qualitative Data Analysis 2014 49 63
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+47 Garritty C Hamel C Trivella M et al Updated recommendations for the Cochrane rapid review methods guidance for rapid reviews of effectiveness BMJ 2024 384 e076335 10.1136/bmj-2023-076335 38320771
+48 Bradbury K Watts S Arden-Close E et al Developing Digital Interventions: A Methodological Guide Evidence-Based Complementary and Alternative Medicine 2014 2014 561320 10.1155/2014/561320 24648848 PMC3932254
+49 Hoffmann TC Glasziou PP Boutron I et al Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide BMJ 2014 348 10.1136/bmj.g1687 24609605
+50 Michie S Richardson M Johnston M et al The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions Ann Behav Med 2013 46 81 95 10.1007/s12160-013-9486-6 23512568
+51 Bardia A Hortobagyi GN Lipatov O et al LBA23 Invasive disease–free survival (iDFS) across key subgroups from the phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2- early breast cancer (EBC) Annals of Oncology 2023 34 S1261 2 10.1016/j.annonc.2023.10.013
+52 Crowe L Brown MC Lecouturier J et al “Oh when’s your treatment ending?” “Never!” The unmet needs of cancer patients treated with immunological, biological and precision therapies: A qualitative interview study Eur J Oncol Nurs 2024 73 102696 10.1016/j.ejon.2024.102696 39500062
+53 Yang L Xue J Yang Z et al Side effects of CDK4/6 inhibitors in the treatment of HR+/HER2− advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials Ann Palliat Med 2021 10 5590 9 10.21037/apm-21-1096 34107710
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+58 Rugo HS Huober J García-Sáenz JA et al Management of Abemaciclib-Associated Adverse Events in Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Safety Analysis of MONARCH 2 and MONARCH 3 Oncologist 2021 26 e53 65 10.1002/onco.13531 32955138 PMC7794176
diff --git a/corpus/healthcare/text/e9df9a02bec8e9f0.txt b/corpus/healthcare/text/e9df9a02bec8e9f0.txt
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index 0000000000000000000000000000000000000000..2a284752c1c077a2d406db11a5985e96b91a3eed
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@@ -0,0 +1,417 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Chiropr Man Therap
+Journal ID: Chiropr Man Therap
+NLM Journal ID: 101551481
+
+Chiropractic & Manual Therapies
+
+EISSN: 2045-709X
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13019774
+PMID: 41709335
+DOI: 10.1186/s12998-026-00630-6
+Article ID: 630
+Article version: 1
+Subjects: Research
+
+Crafting the future of chiropractic research in the UK: designing sustainable practice-based research networks through qualitative exploration and logic model
+
+Holmes Michelle M. michelle.holmes@hsu.ac.uk
+1
+Miller Amy 2
+Newell Dave 2
+1 Centre for Workforce and Systems Innovation, Health Sciences University, Bournemouth, UK
+2 https://ror.org/03rd8mf35 grid.417783.e 0000 0004 0489 9631 AECC School of Chiropractic, Health Sciences University, Bournemouth, UK
+Electronic publication date: 2026 Feb 19
+Publication date: 2026
+Volume: 34
+Electronic Location ID: 7
+Received 2025 Nov 11; Accepted 2026 Feb 11
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Practice-based research network, Health services research, Community networks, Workforce
+
+Funding: Chiropractic Research Council
+issue-copyright-statement: © Chiropractic and Osteopathic College of Australasia, European Academy of Chiropractic, The Royal College of Chiropractors, Nordic Institute of Chiropractic and Clinical Biomechanics and BioMed Central Ltd. 2026
+
+Ÿ==============================Ÿ
+Background
+
+Compared to other health professions, the chiropractic profession lacks a substantive research culture and research capacity, including limited involvement of chiropractors and low recruitment in practice-based research. One recommendation is the establishment of Practice-Based Research Networks (PBRN). This research aimed to explore the feasibility and models of PBRNs informing recommendations for the UK and the wider chiropractic profession.
+
+Methods
+
+Qualitative interviews with key stakeholders explored potential barriers and opportunities of PBRNs in the UK chiropractic setting. Participants included UK chiropractors, UK academics, representatives from organisations in the UK, and international researchers who had developed or utilised PBRNs. Qualitative findings were analysed using thematic analysis and synthesised with findings of literature on PBRN development, to formalise a model for PBRN development and delivery.
+
+Results
+
+Thirty stakeholders participated in an interview. Five themes were developed from the synthesis of the qualitative themes and literature. This included: (1) Purpose of PBRNs within chiropractic, (2) Models and organisational structure of PBRNs, (3) Financial support for PBRN sustainability, (4) Enhancing chiropractor engagement, and (5) PBRN sub-study considerations. Participants highlighted the benefits of PBRNs to the profession and identified a series of recommendations around PBRN infrastructure and activities, which were developed into a logic model to support future PBRN development and delivery.
+
+Conclusions
+
+This study demonstrates the potential benefits of PBRNs in chiropractic, in the UK and internationally. Although several challenges to their development were identified, opportunities and solutions were offered to facilitate a PBRN in the chiropractic context. This research underpins recommendations for the future development, launch and sustainability of PBRNs within the profession in the UK and beyond.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12998-026-00630-6.
+
+Introduction
+
+The chiropractic profession lacks a robust research culture and routine clinical data collection in comparison with other healthcare professions, who have embraced evidence-based approaches to practice with sustainable research infrastructure to support research capacity, productivity and impact [1]. There remains a lack of research capacity across the profession, despite calls for more research and previous work developing research priorities for the profession [2–4]. In part, this is due to the majority of chiropractors working in private practice [5]; operating outside mainstream healthcare systems limits access to research funding and training opportunities, with professions operating outside of traditional health services often facing funding challenges [6]. With limited incentives for research participation, there are challenges involving chiropractors in research or securing sufficient patient numbers in practice-based data collection. Additionally, some chiropractors perceive research as detached from real-world practice, designed by academics who overlook clinical realities [7].
+
+This perceived disconnect reduces engagement with research initiatives. Lastly, there is considerable heterogeneity of effort in the UK research environment, partly due to limited knowledge of ongoing research efforts. Ideological differences among chiropractors, and the multiple associations, further exacerbate this, with conflicting views on the profession’s identity and priorities [1]. These long-standing divisions have hindered unified research efforts, consensus on research priorities, and support or funding for collaborative initiatives. Consequently, the profession continues to face challenges in developing a cohesive research framework.
+
+Research capacity is also limited in the UK, both in terms of funding and availability of research-trained chiropractors. Specific funding for chiropractic research is dependent on the UK chiropractic profession, through levies, charitable giving, or ring fencing a proportion of membership fees. In academic institutions offering chiropractic training, resources to support academic staff to acquire high-level research experience is limited [4], which is markedly different from research intensive universities, with a success in highly competitive funding, thriving research culture and impactful research groups. There have been several activities to increase opportunities for chiropractic research, particularly focused on recent graduates and early-career researchers, including the UK Programme for Early Researchers in Chiropractic [8] and the international Chiropractic Academy for Research Leadership programme [9, 10]. Whilst initiatives such as these provide opportunities to develop impactful networks and research outputs, these initiatives are dependent on funding, and as such are limited in the number of individuals who can access the programmes. Reflecting the chiropractic profession internationally, the UK chiropractic research landscape is characterised by a small proportion of clinical and academic researchers [10], who underpin much of the UK chiropractic research productivity and impact.
+
+` One recommendation to increase research capacity within the profession is to establish a Practice-Based Research Network (PBRN) [11]. PBRNs are not new to the chiropractic profession, with previous work providing guidance on conducting practice-based research projects [12–14]. PBRNs serve multiple functions, firstly PBRNs aim to engage clinicians, practices, and researchers to work together on research activity, using data collected within clinical practice to create an evidence-informed culture within primary care [15–17]. A second vital function of PBRNs is to provide real-world clinical data, reflecting health service delivery and primary care practice [18], which is particularly valuable in complex interventions such as chiropractic. The research from PBRNs is designed to answer real-world questions with practitioners driving the research agenda [17, 19, 20]. With the research reflective of clinical practice [17, 21, 22], PBRNs can facilitate evidence-based practice [6, 13], whilst providing a mechanism for translation of research findings into practice [20, 23]. The development of a PBRN also allows professions to build a research culture and develop research capacity [6, 13, 21]. This includes development of a research infrastructure to increase research capacity, collaboration, and outputs [24].
+
+There are several existing PBRNs within chiropractic and other musculoskeletal professions. One successful PBRN is the Australian Chiropractic Research Network (ACORN). Research opportunities within this PBRN have explored a range of areas including, but not limited to, basic science, clinical outcomes for a variety of special populations, public health and health services research [24, 25]. Another is the Practitioner Research and Collaborative Initiative (PRACI), open to 15 complementary medicine professions in Australia, including musculoskeletal practitioners [17]. ACORN and PRACI have provided a blueprint for the development of other PBRNs such as the Swiss Chiropractic PBRN [26].
+
+Whilst literature suggests that PBRNs are beneficial structure to improve research capacity, there is limited comprehensive guidance on developing and sustaining PBRNs. The aim of this project was to explore the feasibility and models of PBRNs informing recommendations for the UK.
+
+Methods
+
+Design
+
+This study took a qualitative exploratory approach, utilising semi-structured interviews to obtain an in-depth understanding of stakeholders’ views of the development and delivery of PBRNs within the chiropractic profession. Qualitative themes were reviewed against literature to form a model of PBRN development and delivery. Ethical approval for qualitative interviews was approved by Health Sciences University ethics committee (Ethics number: SOC-0921-001).
+
+Participants
+
+To provide a comprehensive picture of PBRNs in chiropractic, it was important to sample stakeholders from across the chiropractic profession. This included UK academics (both researchers and educators), UK chiropractic professional organisations, UK based chiropractors, and individuals with experience in chiropractic PBRNs internationally. Purposive sampling was used to invite UK academics and international PBRN researchers to the study; 33 people were invited to participate in qualitative interviews, including 16 stakeholders from across the chiropractic profession, and 17 researchers with experience and expertise in PBRNs internationally. UK chiropractors and representatives from chiropractic professional organisations were recruited using convenience sampling, via researcher networks and social media recruitment. Recruitment, data collection and data analysis were conducted simultaneously, continually reviewing for data adequacy.
+
+Data collection
+
+Online semi-structured individual interviews were conducted with participants to understand their views on PBRNs and the process of developing and delivering a chiropractic PBRN in the UK. Interviews were undertaken by two post-doctoral academics based in the UK, who have prior experience with qualitative interviews (AM, MH). Due to the small field of chiropractic research, the interviewers were known to many of the participants. A topic guide for the interviews was developed and reviewed by all three authors (see Table 1). In line with a semi-structured, reflexive approach, interview questions were flexible to encourage a discussion-like feel to the interview. Interview questions for the UK chiropractic profession (chiropractors, academics, and organisation representatives) focused on participant understanding of PBRNs, recruitment of chiropractors, and infrastructure for PBRNs. Interview questions for those involved in PBRNs internationally focused on involvement in PBRNs, factors for successful PBRNs, and recruitment of chiropractors. The interviews had an average duration of 37 min. Interviews were recorded with permission from participants and then transcribed verbatim and inputted into the computer-assisted qualitative software NVivo [27].
+
+Table 1 Interview topic guide
+
+Interview questions with the chiropractic profession	Interview questions for PBRN researchers	
+Are you currently or have you ever been involved in research?
+
+What is your understanding of PBRNs?
+
+What are your thoughts on how a PBRN might work?
+
+When building a PBRN, we would need to recruit chiropractors and their practice, how do you think we could recruit them?
+
+What type of support would you and your practice need to make participation in research feasible?
+
+	Can you take me through your involvement in PBRNs?
+
+What are your thoughts about PBRNs in chiropractic?
+
+When building a PBRN, you need to recruit clinicians and their practice, what did you think about the recruitment process?
+
+What support do you think is needed for PBRNs?
+
+What do you think are important things to consider before setting up a PBRN?
+
+	
+
+Data analysis and model development
+
+The analysis was conducted following published guidance on thematic analysis, providing a systematic and transparent process of conducting qualitative data analysis [28–30]. Stage 1 involved familiarisation with the data, listening to the audio-recordings, transcription, and re-reading the transcripts, with initial notes made at this stage. Stage 2, initial inductive coding, was conducted by one author (MH), describing the data and interpreting the data content. This was conducted at each stakeholder level (UK academics, chiropractors, PBRN experts, and chiropractic organisations in the UK). After initial coding, 244 codes were developed. After all interviews were coded, codes were examined to identify similarity and differences (Stage 3). Codes were refined during Stage 4, including collapsing codes that were similar constructs by two authors (MH, AM). In this step, themes were generated across the four stakeholder groups, based on broad topics in which codes were clustered.
+
+Stages 5 (refining, defining and naming themes) and 6 (writing up) of Braun and Clarke [28–30] were completed in the context of a broader synthesis combining the qualitative findings and existing literature; the synthesis aimed to formalise a model for PBRN development and delivery, considering the context, mechanisms, and outcomes [31]. During the interview and analysis process, a literature search was concurrently undertaken on PubMed, CINAHL, Cochrane Library, and AMED using keywords and MeSH terms on derivatives of PBRNs. Commentaries, reviews and editorials published in English were eligible for inclusion [32, 33]. Papers were included if they focused on PBRNs development generally, or within primary care or musculoskeletal healthcare. Study titles and abstracts were screened to assess eligibility, followed by screening of full texts by two reviewers (MH and AM). The process is documented in supplementary material [1]. Data extraction from literature was undertaken through note-taking, considering common patterns, and were mapped against the the findings of the qualitative interviews [32, 33].
+
+Potential themes across the literature were reviewed against the qualitative dataset to form a logic model of PBRN development and delivery within chiropractic, including the population, inputs and activities of the PBRN, and the outputs and outcomes. This was based on the logic model for the South Texas Ambulatory Research Network (STARNet) [34]. In addition, qualitative findings on chiropractors’ involvement in research [35] and use of data collection tools [36] were integrated to further refine the model. Several iterations of the model were developed, to ensure that no elements were missing. Textual descriptions summarising the literature are provided for each element of the theory with supporting empirical evidence. Examples and verbatim quotes are presented to best illustrate the dataset and describe the findings. The study has been written in line with the RAMESES guidance for reporting realist syntheses [37] and the COnsolidated criteria for REporting Qualitative studies (COREQ) checklist [38].
+
+Results
+
+Overview and participants
+
+Of the 33 people purposively sampled, based on their position in the UK chiropractic academics and organisation representatives or international PBRN experience, 25 agreed to be interviewed, including 14 chiropractic stakeholders and 11 researchers. A further convenience sample of five UK chiropractors participated in interviews, following their response to online recruitment. The thematic analysis resulted in findings being organised into nine themes. Within the synthesis, the qualitative findings were mapped against the literature and organised into the following final themes: (1) Purpose of PBRNs within chiropractic, (2) Models and organisational structure of PBRNs, (3) Financial support for PBRN sustainability, (4) Enhancing chiropractor engagement, and (5) PBRN sub-study considerations. The following sections describe each of the findings, noting stakeholder views, with example quotations from participants.
+
+Purpose of PBRNs within chiropractic
+
+Participants from the qualitative interviews identified a lack of research culture and apathy for research within the chiropractic profession, noting limited involvement from chiropractors in research due to individual knowledge and “a lack of awareness in terms of what to do to be research active in a clinical setting.” (P25—academic). This understanding of research was felt to be widespread among the profession, impacting on research capacity: “I think it's very poorly understood and undervalued generally across the profession.” (P30—organisation).
+
+Participants compared the chiropractic profession to other healthcare professions: “There's some still some issues around, you know, identity and reputation etcetera and I think there's a feeling that there's a lack of research” (P12—academic). Participants highlighted the need for the profession to grow research capacity and provide more evidence to support chiropractic: “I just worry about the profession and its future if there is limited or a lack of coming together, researching and the profession evolving” (P17—organisation).
+
+A PBRN was seen as a positive way to build research culture as “a way of getting the profession engaged” (P12—academic). A PBRN was defined as a collaboration between clinicians and academics conduct research, consisting of “a group of clinicians who are interested in research” (P6—academic) who would like the opportunity to participate in research. PBRNs were thought to ease data collection and provide opportunities for pragmatic research, enhancing the quality and volume of data. The PBRN connects “researchers with appropriate clinicians for project development and data collection.” (P26—academic) with data directly from clinical practice highlighting “from what's happening in the real world” (P5—chiropractor).
+
+Participants highlighted benefits of PBRNs to move the profession forward “by collecting certain data it may be useful for wider stakeholders external to the profession that needs certain information in order to trust the profession more” (P3—chiropractor). However, it was felt that for chiropractors the “ultimate benefits are seeing some research that is helpful for their practice.” (P30—organisation), with PBRNs providing an opportunity for more data and evidence focusing on patient care, with one academic stating that the “main mission has to be geared towards public benefit” (P26—academic).
+
+Models and organisational structure of PBRNs
+
+Interviews with PBRN researchers highlighted two different models of PBRNS: a registry model and a sub-study model. The registry model is focused on coordinated regular collection of patient data using a patient record system. The sub-study model design utilises a practitioner PBRN database, with the initial data collection focused on practitioner-reported data.
+
+All stakeholders identified a difference between the two models, acknowledging that although the registry model would provide a larger volume of data, stakeholders felt that this was not feasible. One researcher involved with PBRN development internationally reflected that chiropractors “are all wedded, emotionally almost, to their favourite clinical practice software” (P21—researcher). It was noted that to make a registry model operational and for standard data collection processes to be implemented “you're going to have to bring in some sort of system that doesn't already exist in order to collect data.” (P9—researcher). Based on the recommendations of PBRN researchers and the challenges raised by chiropractors and chiropractic stakeholders in the UK, the sub-study model was seen as the most appropriate model for current clinical practice.
+
+Participants noted that a PBRN would need organisation and management, requiring “capacity to operate it, you know, to operate the system, to manage the system. So it's not just setting it up, it's the ongoing work with it, so you know, issues about ownership and licensing updating the system, the administration of it” (P30—organisation). Many academics agreed that a UK educational institution should take a strategic role in setting up the infrastructure and project management of a PBRN. One academic stated “Devolving it from the educational institutions, I think would almost be impossible” (P16—academic).
+
+The additional challenge of the political nature of chiropractic was noted by organisations. It was felt that it was important to get leaders of organisations on board to encourage members to get involved. One academic identified that the message should be collaboration across all associations, organisations, and clinicians, recommending “a big launch at the right time rather than this sort of little trickle effect coming from different people with different messaging. I think it's getting that absolutely clear. Big launch, everyone supporting it” (P22—academic). Participants identified that organisations could help their members understand the PBRN, what it is, and why it is important. “Not everyone's obviously a member of a professional association. But if the messages were coming from everybody. Then I think that would be much, much stronger” (P17—organisation).
+
+Financial support for PBRN sustainability
+
+Throughout the interviews it was highlighted that a PBRN “requires an infrastructure” (P11—researcher). Along with this, researchers involved in PBRN’s internationally stressed the importance of funding, and the funding required for PBRN development, infrastructure and ongoing support. A lack of funding was identified within the literature as a key challenge to supporting PBRN infrastructure and activities: “If you can’t get funding, then I just don’t think you should do it” (P10—researcher). International start-up costs varied, although this was noted in the success and long-term sustainability of the project. Researchers noted that these costs varied from £8000 to £200,000 in start-up costs. The start-up costs often related to travel, marketing materials, and attendance at events to market the network. Ongoing infrastructure costs included items such as a director, administrator, marketing materials, travel and meetings.
+
+The ongoing financial support was noted as challenging if dependent on grant funding: “how do you sustainably maintain this thing? Cos, you know, and we struggle in the research world. I suspect you guys do too, where you can get a great injection of funds to build it. But how do you sustain it?” (P11—researcher). Organisational representatives in the UK said they might be able to financially support the project as they funded research previously “the other thing that we do is we sponsor studies. So either a researcher or a university or something come to us with a proposal and we fund it.” (P29).
+
+The funding for PBRNs also included administration costs. Primary care research and research conducted within PBRNs have several administrative requirements, with the suggestion that some administration should sit centrally “you wouldn't want to be having to recruit that administrator each and every time. So they've got to be employed by the PBRN” (P27—organisation). A researcher with previous involvement in PBRNs identified the need for a “designated central admin person that could keep people engaged and distribute things and set up meetings, that would probably be helpful. Umm, so setting that infrastructure up from the beginning. Rather than having researchers do a lot of that stuff” (P23—researcher).
+
+Enhancing chiropractor engagement
+
+Practitioners joining a sub-study model PBRN means consenting to be on a database of practitioners open to receiving invitations for future research projects. A PBRN researcher noted the value in this approach as “A ready-made army of willing practitioners. And it's a phenomenal resource for any research team to be able to get their hands on” (P21—researcher). Chiropractors could also be advocates for the PBRN, involved in the recruitment of practitioners and feedback by practitioners to the network: “A champion basically that just says, come on, you know this, you told me you'd like to participate. This is your chance. And let's do this.” (P13—researcher).
+
+Common barriers for practitioners to engage with PBRNs include lack of time and competing priorities, low interest in the research topic, and limited research skills. One academic noted that “there isn't buy in from the profession in that the majority chiropractors don't see that research is part of their job.” (P25—academic). From their previous experience in engaging chiropractors in research, representatives from chiropractic organisations commented on chiropractors not seeing the benefit of research “unless it's interesting and inspiring to them and they feel like it's gonna take the profession forward, I just know they won't participate” (P29—organisation).
+
+Existing PBRNs within chiropractic have used various strategies to engage with the profession. For small PBRNs this involved snowball recruitment “We just started, yeah, contacting clinicians in the area. Some we knew, some we didn't, and just garnered interest” (P9—researcher). However, others took a more structured approach to recruitment. Important messages were noted surrounding improving practice: “enabling clinicians to see the benefit to chiropractic and maybe some benefit to themselves and their patients as well.” (P30—organisation)”, “I think there is there is a sense of and instilling into people, giving back to the profession” (P25—academic). A prior PBRN reflected on the impact this had on recruitment “the one thing that brought people back to the table all the time was just to focus on the only reason we're all there and that’s patient-centred care” (P13—researcher).
+
+Several ideas to increase involvement were identified. This included recognising PBRN involvement as continuing professional development, solving two problems “lot of people do struggle to get their hours” (P5—chiropractor). Other recommendations included hosting seminars, academic talks, and guest speakers through the PBRN. This also enabled the chiropractor to see the impact of participating: “I think that what the profession would want to see is that we want to see the real-world consequences of things.” (P4—chiropractor).
+
+PBRN sub-study considerations
+
+Within the sub-study model, it is important to complete a baseline study, providing member registration details, including clinician information, description of the clinic, and basic patient population information “shows elements of practice and practice behaviours and practice shouldn't characteristics for the workforce” (P10—researcher). At the end of the baseline study, participants are encouraged to consent to their contact details being stored on a database of practitioners for engagement and identification of practitioners for specific studies. However, another membership was concerning to one organisational representative, “It's always a heart sink moment when I hear of yet another organization that's been that's been set up within chiropractic, you know.” (P14—organisation).
+
+Sub-study steering committees can be implemented to decide on approval of new research studies: “we assessed all the sub studies that came through and made sure there were standard” (P10—researcher). Prior PBRNs required studies to have both researchers and practitioners on the research team: “it had to be led by an academic, but you had to had a have a co-investigator that was a clinician and the community that would help to facilitate and I think that worked really well. Just having a clinical lead who was, you know, kind of your advocate for the… PBRN.” (P9—researcher).
+
+Practitioners in the PBRN can decide on their involvement in each sub-study. Chiropractors reflected on wanting to participate in studies that were simple in design and how they decided to participate: “How quick and easy it is to collect the information that is that for me that would be the sole thing that would sway it yes or no, is that, how easy it would be” (P5—chiropractor). This was also noted by academics as an issue from previous research “Researchers must be conscious of practitioner time, I think some of the barriers are gonna be time. They're gonna say how you know, how much time does this take? I've got too much admin as it is.” (P12—academic).
+
+Incentives were recommended to be a reasonable reimbursement for their time and effort, to increase participation and manage engagement with sub-studies: “there has to be appropriate acknowledgement and reimbursement relative to the work that's being done, not to a point where it's overly incentivizing them” (P10—researcher). Researchers highlighted this might be something small, “it's just receiving something as a gift for recognition” (P13—researcher). Examples from the qualitative interviews included a gift card acknowledgement and a raffle to win vouchers or wine. One researcher provided an example of providing recognition to involved clinics: “we would send them some chocolates or flowers or whatever to say, hey, you're doing good, great. And maybe that's even more important than the payment that we really hear from many clinics” (P20—researcher). However, organisations proposed financial reimbursement for larger studies: “you'd need to be cognizant of the cost implications to the clinician and try to offset that would get better buy in” (P27—organisation). In some cases, CPD points prove to be preferable and more enticing that monetary gifts, with chiropractors suggesting incentives such as “Discount on the course or something like that, or you know, or a free online course that you can do” (P5- chiropractor).
+
+Discussion
+
+The aim of this project was to explore the feasibility and design of a PBRN for the chiropractic profession in the UK. The findings of this research have identified several benefits for the development of PBRNs. Real-world research can be enhanced through a PBRN. PBRNs can facilitate researchers and practitioners to produce relevant research to health care delivery [24]. A logic model (see Table 2) was developed to depict a PBRN within chiropractic, including the population, inputs and activities of the PBRN, and the outputs and outcomes. This research model enables collaboration between researchers and practitioners, helping to identify, establish and address research priorities focused on patient needs [39], providing pragmatic clinically relevant research from practice [6].
+
+Table 2 Logic model of PBRNs
+
+Population	Organisational input	Activities	Output	Outcomes	
+UK chiropractors—working in private practice (independent or within a group)
+
+UK chiropractic researchers (or those working within the field of musculoskeletal research)
+
+Chiropractic organisations (regulators, professional associations, professional membership bodies)
+
+Chiropractic patients
+
+	Advisory committee including director
+
+Administrator
+
+Chiropractors
+
+Practitioner advocates
+
+Researchers
+
+Sub-study steering committee
+
+Patient and public representatives
+
+	Recruitment of practitioners
+
+Baseline study
+
+Development of membership list
+
+Sub-study steering committees
+
+Meetings
+
+Regular communication (including research priority setting and dissemination)
+
+	Number of practitioners recruited
+
+Number of sub-studies
+
+Publications of sub-studies
+
+Number of meetings and network events
+
+Attendance at meetings at network events
+
+	Development of a membership list for future research
+
+Development of research active clinicians
+
+Increase in chiropractic research
+
+Dissemination of research and implementation of evidence into practice
+
+Improvements in patient care
+
+	
+
+The findings of this study identified several key elements to consider within the development of a UK-based PBRN for chiropractic. Our findings broadly reflect the models and structures reported in successful PBRNs internationally [17, 24–26]. and generally, tend to confirm rather than diverge from the wider literature on PBRN development and sustainability. The literature identified the two models of PBRNs as discussed in the interviews, the registry model and a sub-study model [25]. From the literature, chiropractors note a need for a patient outcome software integrated with clinical software alongside health records, currently used software required improvements to facilitate a registry model [36].The sub-study approach, as noted within the qualitative findings, is flexible and allows for a variety of study designs, including those utilising patient data records [25].
+
+Specifically, the participants in this study emphasised the same core features consistently identified in established PBRNs. For example, a shared purpose [40, 41], robust governance and infrastructure beyond individual studies [13, 17, 20, 21, 23, 42], sustainable funding [16, 21, 43] and active strategies to support clinician engagement [19, 39, 44–47]. In. Our findings further suggest that in settings dominated by independent private practice such as UK chiropractic, these requirements may be even more important reinforcing the need for clear and explicit value propositions and central coordination to support long-term participation and network longevity. The findings of this work synthesise the learning from previous work in the chiropractic profession and bring insights from wider PBRN literature, to ensure sustainability of future PBRN development in the UK.
+
+Despite noting the benefits of PBRNs and the positive impact on chiropractic research culture, participants identified multiple challenges. Issues identified included the model of PBRN delivery, with debates over the registry or sub-study model of PBRNs [25]. Although the registry model provides opportunities to collect routine patient data [24], the infrastructure required for this model is substantial and will require a significant change in the chiropractic profession. However, the sub-study model was identified as a relevant, pragmatic and useful model for a U.K. chiropractic PBRN. The model allows for the data to be explored by researchers and is a flexible approach for future studies, including those utilising patient data records [6, 25].
+
+Questions were raised about the ownership of the PBRN an administration. There are three main types of organisational structure for a PBRN: operating via an academic institution, private organisations, and community-based participatory research [20]. In a 2011 review of 143 PBRNs registered with the Agency for Healthcare Research and Quality, 64.9% had a university as a primary affiliation, with 29% affiliated with a non-for-profit organisation [23]. Throughout the interviews, differing views were raised, with the consensus that an academic institution would have the infrastructure and ability to host a PBRN, however this should be run as an independent project with its own identity. Suggested infrastructure for PBRNs includes strategic leadership and administrative support, independent of a single study, to allow for the management and quality assurance of activity [48, 49]. Across PBRNs, strategic leadership often comes from a steering committee, to coordinate activity [21, 24, 50, 51]. Guidance on PBRN development suggests a research director takes overall responsibility for overseeing the network, including the management and operation of the PBRN through identifying practitioner advocates, writing marketing materials, recruitment of members, leading meetings, and launching projects [17, 19, 47], with administrative support [21, 43, 47].
+
+PBRNs were noted to require sustainable funding [15], and it was recommended that PBRN development should not commence without this in place. In 2005, it was estimated the annual cost of a basic PBRN would be $69,700 (£55,000) with more complex networks costs estimated at $287,000 (£226,000) [43]. PBRNs are recommended to pursue alternative sources of funding to support infrastructure and activities. However, this must align with the mission and vision of the PBRN [16]. Funding could come from chiropractic associations, and this support has been seen from existing PBRNs. For example, the ACORN project was funded by the Chiropractors Association of Australia [24].
+
+Previous research identified the issues in recruitment of chiropractors and their participation in research [35]. Noting that practitioners have limited time [19], recruitment of practitioners will continue to be a known issue with a PBRN. Significant investment needs to be made to involve practitioners at every level of the PBRN [17] and there must be ongoing engagement with the practitioners in the PBRN [15]. Previous recruitment activity has included emails to professional associations, news items for professional body newsletters, presentations at national and regional seminars and conferences, and a website providing an overview of the PBRN and the benefits and value to participating [17, 25]. Other recommendations included practitioner and public involvement in the sub-study steering committee and each sub-study team. Important potential benefits should be clearly communicated in the recruitment of chiropractors, including opportunities to contribute to research questions/projects, collect real-world data, work with researchers to implement new research findings in their practice, and be part of the network with access to other practitioners and research. Other recommendations from the literature included fun rewards such as food, gifts, or personalised thank you cards from the lead researcher [45]. Continuing professional development hours were another suggested incentive, which has been shown to be an incentive to participate [39]. Financial incentives have been shown to not increase participation but are associated with study completion [52]. In addition, a PBRN must manage the relationship with the practitioners in the network [20]. Recommendations for continued engagement include: an annual report, newsletters, presentations at network meetings, flyers, social media, videos, testimonials [19, 46, 47]. It is also recommended that ongoing engagement should facilitate PBRN members feedback [48], opportunity to develop research questions [53] and disseminate research findings [47].
+
+One criticism of existing PBRNs is the lack of inclusion of patients within steering groups and leadership committees. A survey of 46 PBRNs in the U.S. across primary care networks found that 48% had no community involvement [54]. However, within Southern Primary-Care Urban Research Network (SPUR-NET), researchers meet with patients to incorporate patient perspectives into the research study design and processes [53]. It is recommended that individuals who are familiar with the chiropractic profession are recruited, to encourage patient participation within research, informing the research process from development to implementation [13]. Patient and participant involvement (PPI) should be an expectation of research undertaken in this new chiropractic PBRN.
+
+Strengths and limitations
+
+There are several strengths and limitations to this study. Purposive sampling ensured a wide range of views were included in the study. Out of 33 researchers or representatives from organisations invited for interview, 25 took part in an interview. Only one organisation in the UK did not participate in an interview. Unfortunately, this highlights the difficulty of completing research and creating a PBRN in a fragmented profession. Due to social media recruitment, it is unknown how many chiropractors were invited to participate, and the small number of chiropractors who took part in the interview may represent only the views of chiropractors willing to take part in this type of research. This was supplemented by utilising existing literature on chiropractic involvement in research [35], which provides a comparison of participants to the wider chiropractic profession.
+
+The interviews, coding and analysis were all conducted by two researchers, one a chiropractor and one with knowledge and engagement with the chiropractic profession. Although one researcher undertook the initial coding, this was later discussed with two researchers. Data interpretation and refinement of the constructs and theory was conducted in discussion across the team and considering the wider literature on PBRN development, to develop a comprehensive understanding of development of a PBRN in the chiropractic field.
+
+Recommendations
+
+This research has identified core requirements for the development of PBRNs and provides a series of recommendations for PBRN development within the profession and within the development of a UK-based PBRN for chiropractic. This includes the use of a sub-study model, organisational structure requirements, securing sustainable funding, and advice on recruitment and engagement with chiropractors. These have been developed into one core model which can underpin the development and launch of PBRNs within the chiropractic profession. Within the UK, future work should focus on utilising the recommendations and resources for building a PBRN infrastructure to identify and build an advisory committee and secure sufficient funding. Further work should explore the inclusion of patients within PBRN and research committees, embedding the patient voice within the chiropractic research strategy.
+
+Conclusion
+
+This study set out to explore and understand challenges in developing and maintaining a PBRN in the UK. There are several suggested benefits for a PBRN within chiropractic, including conducting real-world research, informing evidence-based practice and providing an infrastructure to develop the research culture. Challenges identified included the hosting of a PBRN, funding, and practitioner engagement. However, solutions and recommendations have identified approaches to recruitment, promotion and administration. The findings provide the chiropractic profession a clear strategy for development and maintenance of PBRNs.
+
+Supplementary Information
+
+Below is the link to the electronic supplementary material.
+
+Supplementary Material 1.
+
+Supplementary Material 2.
+
+Acknowledgements
+
+We would like to thank the members of the project steering committee: Professor David Byfield (Wales Institute of Chiropractic, University of South Wales, UK), Professor Adrian Hunnisett (McTimoney College of Chiropractic, University of Ulster, UK), Professor André Bussières (Départment chiropratique, Université du Québec à Trois-Rivières, CA), Elisabeth Angier (Chiropractic Research Council, UK), Dr Jonathan Field (Royal College of Chiropractors, UK)
+
+Author contributions
+
+DN led the initial conceptualisation. DN and MH secured the funding for the project. MH and AM undertook the qualitative interviews, MH completed initial coding, with discussion between all authors during the interim analysis, and final analysis was completed by both MH and AM. All authors contributed to the writing of the final manuscript.
+
+Funding
+
+This work was funded by the Chiropractic Research Council.
+
+Availability of data and materials
+
+The datasets generated and/or analysed during the current study are not publicly available but are available from the corresponding author on reasonable request.
+
+Declarations
+
+Ethical approval and consent to participate
+
+This study received ethical approval from Health Sciences University, formerly AECC University College, approval number: SOC-0921-001. All participants provided signed consent to participate.
+
+Consent for publication
+
+All participants provided consent for publication of anonymous quotes.
+
+Competing interests
+
+None.
+
+Publisher’s note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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diff --git a/corpus/healthcare/text/ea0b116f0da26092.txt b/corpus/healthcare/text/ea0b116f0da26092.txt
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@@ -0,0 +1,423 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: J Med Internet Res
+Journal ID: J Med Internet Res
+NLM Journal ID: 100959882
+Journal ID: JMIR
+
+Journal of Medical Internet Research
+
+ISSN: 1439-4456
+EISSN: 1438-8871
+Publisher: JMIR Publications Inc.
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11555460
+PMID: 39466300
+DOI: 10.2196/52609
+Article ID: v26i1e52609
+Article version: 1
+Subjects: Review, Review
+
+Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review
+
+de Azevedo Cardoso Taiane
+Parks Acacia
+Boeker Martin
+Lau Carrie K Y MSW 1 2 https://orcid.org/0009-0005-2786-8672
+Saad Anthony BSc, MPH, MD 1 https://orcid.org/0000-0003-1890-1029
+Camara Bettina MSc 3 https://orcid.org/0000-0001-9579-3768
+Rahman Dia BES https://orcid.org/0000-0002-9422-5790
+Bolea-Alamanac Blanca MSc, MD, PhD https://orcid.org/0000-0002-6308-2731 1 4 Department of Psychiatry Women's College Hospital 76 Grenville St Toronto, ON, M5S 1B2 Canada 1 647 331 2707 Blanca.BoleaAlamanac@wchospital.ca
+
+1 Department of Psychiatry Women's College Hospital Toronto, ON Canada
+2 Factor-Inwentash Faculty of Social Work University of Toronto Toronto, ON Canada
+3 Department of Immunology Faculty of Medicine University of Toronto Toronto, ON Canada
+4 Department of Psychiatry University of Toronto Toronto, ON Canada
+Corresponding Author: Blanca Bolea-Alamanac Blanca.BoleaAlamanac@wchospital.ca
+Publication date: 2024
+Electronic publication date: 2024 Oct 28
+Volume: 26
+Electronic Location ID: e52609
+Received 2023 Sep 9; Revision requested 2024 Feb 6; Revised 2024 Feb 27; Accepted 2024 Apr 30
+Copyright: ©Carrie K Y Lau, Anthony Saad, Bettina Camara, Dia Rahman, Blanca Bolea-Alamanac. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 28.10.2024.
+Copyright year: 2024
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: acceptability, mental health, depression, anxiety, mobile app, internet, mobile phone, mobile health, mHealth, digital health
+
+Ÿ==============================Ÿ
+Background
+
+Depression and anxiety disorders are common, and treatment often includes psychological interventions. Digital health interventions, delivered through technologies such as web-based programs and mobile apps, are increasingly used in mental health treatment. Acceptability, the extent to which an intervention is viewed positively, has been identified as contributing to patient adherence and engagement with digital health interventions. Acceptability, therefore, impacts the benefit derived from using digital health interventions in treatment. Understanding the acceptability of digital mental health interventions among patients with depression or anxiety disorders is essential to maximize the effectiveness of their treatment.
+
+Objective
+
+This review investigated the acceptability of technology-based interventions among patients with depression or anxiety disorders.
+
+Methods
+
+A systematic review was performed based on PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) guidelines. We searched PubMed, Web of Science, and Ovid in May 2022. Studies were included if they evaluated digital interventions for the treatment of depression or anxiety disorders and investigated their acceptability among adult patients. Studies were excluded if they targeted only specific populations (eg, those with specific physical health conditions), investigated acceptability in healthy individuals or patients under the age of 18 years, involved no direct interaction between patients and technologies, used technology only as a platform for traditional care (eg, videoconferencing), had patients using technologies only in clinical or laboratory settings, or involved virtual reality technologies. Acceptability outcome data were narratively synthesized by the direction of acceptability using vote counting. Included studies were evaluated using levels of evidence from the Oxford Centre for Evidence-Based Medicine. The risk of bias was assessed using a tool designed for this review and GRADE (Grading of Recommendations, Assessment, Development, and Evaluation).
+
+Results
+
+A total of 143 articles met the inclusion criteria, comprising 67 (47%) articles on interventions for depression, 65 (45%) articles on interventions for anxiety disorders, and 11 (8%) articles on interventions for both. Overall, 90 (63%) were randomized controlled trials, 50 (35%) were other quantitative studies, and 3 (2%) were qualitative studies. Interventions used web-based programs, mobile apps, and computer programs. Cognitive behavioral therapy was the basis of 71% (102/143) of the interventions. Digital mental health interventions were generally acceptable among patients with depression or anxiety disorders, with 88% (126/143) indicating positive acceptability, 8% (11/143) mixed results, and 4% (6/143) insufficient information to categorize the direction of acceptability. The available research evidence was of moderate quality.
+
+Conclusions
+
+Digital mental health interventions seem to be acceptable to patients with depression or anxiety disorders. Consistent use of validated measures for acceptability would enhance the quality of evidence. Careful design of acceptability as an evaluation outcome can further improve the quality of evidence and reduce the risk of bias.
+
+Trial Registration
+
+Open Science Framework Y7MJ4; https://doi.org/10.17605/OSF.IO/SPR8M
+
+Introduction
+
+Background
+
+Depression and anxiety disorders are common [1] and have high and increasing societal costs [2,3]. Patients with depression or anxiety disorders can benefit from psychological treatments but face a variety of barriers to accessing traditional mental health services.
+
+Digital health interventions include those delivered with technologies such as web and mobile apps. They have garnered optimism for their potential to lower barriers to accessing mental health services [4,5]. Digital mental health interventions can facilitate access to services by increasing convenience for patients and reducing demands on their time, eliminating geographic limitations, reducing costs, and increasing the capacity of health systems [6].
+
+The use of digital mental health interventions increased during the COVID-19 pandemic [7,8]. Their expanded reach occurred amid public health measures that limited in-person mental health treatment and predictions of a long tail of mental health repercussions [9]. Digital mental health interventions are now commonly available to patients alongside other mental health services, as an adjunct to in-person or synchronous video-based mental health treatment, or as a stopgap for long waitlists [10,11].
+
+However, uncertainty exists around patient adherence to digital mental health interventions. Significant variations in adherence levels, ranging from low to high, have been noted among digital interventions [12]. Issues with nonadherence cast some doubt on whether the potential benefits of digital mental health interventions can be realized. Related issues have been found with user engagement (initiation and continuation of use of a digital health intervention) [13] among digital mental health interventions.
+
+Acceptability, the degree to which individuals view a treatment or potential treatment positively, has been identified as predicting adherence and user engagement [14], and ultimately the intervention’s effectiveness [15]. Acceptability among patients is therefore critical to realizing the potential of a digital mental health intervention.
+
+Research into acceptability appears hampered by its varying conceptualizations. Sekhon and colleagues [16] propose that acceptability is the patient’s perception of the treatment as appropriate, arising from their cognitive and affective reactions. They also provide a theoretical framework for acceptability with 7 components: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy [16]. Furthermore, Sekhon and colleagues [16] also recommend measuring acceptability at different time points during the intervention.
+
+By contrast, Proctor and colleagues [17] define acceptability as the patient’s perception of the intervention as satisfactory or tolerable. Zauszniewski [18] describes acceptability as patients’ belief that the intervention is logical and suitable to them. They also describe 3 main components of acceptability, such as the acceptability of an intervention’s delivery method, acceptability of the content of an intervention, and acceptability of the provider of the intervention, although they acknowledge that acceptability is often assessed only as a whole [18]. In contrast, the technology acceptance model proposed by Davis [19], regarding attitudes toward technology and its use more generally, presents acceptability as hinging upon users’ perceptions of ease in using the technology and the technology’s usefulness.
+
+Conflict between the constructs of acceptability and satisfaction has also been identified, with recommendations that acceptability be understood as distinct from satisfaction [16,17]. However, studies continue to operationalize acceptability as a patient’s satisfaction with a treatment, indicating continued resonance with the construction of satisfaction as a representation of acceptability, or at least a lack of consensus.
+
+These examples demonstrate the variation with which acceptability has been understood and investigated in evaluations of digital mental health interventions thus far. Despite past recommendations for improvement (eg, Sekhon and colleagues [16]), evaluations have not yet converged on a particular approach to patient acceptability.
+
+Acceptability has implications for user engagement and adherence [14]. Acceptability can impact the benefit that a patient can derive from an intervention and, in turn, compromise or enhance the individual’s investment into digital mental health interventions. It is of particular importance to investigate the acceptability of digital interventions for patients with depression and anxiety disorders, given the prevalence of these diagnoses and the frequency with which clinicians are required to identify appropriate psychosocial interventions [1].
+
+Aims and Objectives
+
+This review summarizes the acceptability of digital mental health interventions for depression and anxiety disorders among adult patients. The research question we investigated was the following: “How acceptable to adult patients with depression or anxiety are digital mental health interventions (such as mobile apps) used in psychiatric care, and what is the evidence for their acceptability?” We accomplished this by identifying evaluation studies of digital mental health interventions where acceptability is one of the outcome measures, reviewing the quality of the available evidence for acceptability, and summarizing the acceptability of digital mental health interventions to patients with depression and anxiety disorders.
+
+Methods
+
+Overview
+
+We started with Sekhon and colleagues’ [16] theoretical framework for acceptability, which identified in acceptability the component constructs of affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. We selected this theoretical framework because these component constructs can readily be identified in research studies having acceptability as an outcome measure. Where a study had an outcome measure that assessed one or more of these component constructs, whether or not the same terminology was used, the measure was considered relevant to our study.
+
+In addition, the abovementioned theoretical framework for acceptability recognizes different temporal assessments of acceptability, such as prospective acceptability (before the intervention), concurrent acceptability (during the intervention), and retrospective acceptability (following the intervention) [16]. Each temporal assessment of acceptability is understood to achieve a different purpose and to provide different information [16]. For the purposes of this review, we included studies that assessed acceptability at any of these multiple time points but took note of the time points selected by the researchers for further analysis and discussion.
+
+Sekhon and colleagues [16] suggest that satisfaction and acceptability are constructs that are often confounded but should be differentiated, referencing the fact that satisfaction can only be retrospectively assessed, while acceptability can be assessed at all time points. For this study, satisfaction is considered an aspect of retrospective acceptability. We therefore took into account measures of satisfaction as relevant to our review, despite satisfaction not being a part of Sekhon and colleagues’ [16] theoretical framework.
+
+Other constructs not named within Sekhon and colleagues’ [16] theoretical framework of acceptability and included in this review are credibility, expectancy, and usability. For this review, studies evaluating credibility, expectancy, and usability were eligible for potential inclusion as long as the measures assess one or more component constructs of acceptability. Studies identified by their authors as collecting feedback, experiences, attitudes, subjective appraisal, and subjective benefit were similarly eligible for inclusion if they provided information on one or more component constructs of acceptability.
+
+Inclusion and Exclusion Criteria
+
+Studies were included if (1) they investigated digital mental health interventions that monitor or treat depression or anxiety disorders; (2) they evaluated internet-based, mobile, or computer-based mental health interventions, and could involve the use of such technologies as mobile apps or web-based treatment modules; (3) their participants were 18 years of age or older; and (4) they collected data on the acceptability of the intervention to their participants.
+
+Excluded were studies that (1) focused on behavioral or lifestyle changes in healthy people; (2) focused on a physical health condition, a neurodevelopmental condition, or a mental health diagnosis other than depression or an anxiety disorder; (3) focused on a specific population such as military personnel, health care workers, students, or a target group representing only one component of a larger population; (4) focused on family members or caregivers; (5) evaluated technologies that act as a conduit to traditional care but add no potential therapeutic value, such as videoconferencing platforms used for remote psychotherapy; (6) evaluated interventions that used virtual reality technology; (7) did not have participants interacting directly with the technology for therapeutic purposes (eg, sensors used by clinicians to collect data without offering therapeutic feedback to participants); (8) had participants <18 years of age; (9) had participants using the technology exclusively in clinical or laboratory settings; or (10) were not completed at the time of searching (eg, study protocols captured in database searches).
+
+Database Review
+
+The review was conducted in 3 locations, PubMed, Web of Science (all databases in their Core Collection), and Ovid (all databases in their Health Sciences, Life Sciences, and Social Sciences categories). Search terms comprising both free text or natural language and Medical Subject Headings (MeSH) were applied in these searches (Multimedia Appendix 1). The searches were performed in May 2022 with no filters used to restrict the time period of the articles, and as a result, the oldest article in our search dated back to 1987. Reverse searches were also conducted by reviewing the references of relevant systematic reviews and meta-analyses, and by reviewing the references of included articles. Only articles with English abstracts were considered, but main texts could be in English, French, German, Italian, Spanish, or Chinese. Searches for gray literature using the same terms identified relevant published dissertations. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and PROSPERO (International Prospective Register of Systematic Reviews) [20] guided this review. The review was conducted using conventions for systematic reviews, screening first by title and abstract, followed by reviewing the complete article text. Furthermore, 2 reviewers (CKYL and one of AS, BC, or DR) independently assessed each title and abstract, and each complete text, to determine inclusion or exclusion. Disagreements in these assessments were resolved with further discussion (involving the reviewers and BB-A). The database software Covidence (Veritas Health Innovation Ltd) was used to organize and review the studies [21].
+
+Data Extraction and Synthesis
+
+Data were captured from the included articles by the first author (CKYL) in a table format, checked by the last author (BB-A), and approved by all the authors. These data comprised the following: (1) depression or anxiety disorders needed for study eligibility, (2) details of the intervention (ie, mode of technology used, program name if one exists, and treatment paradigm), (3) details of the participant sample (ie, sample size, breakdown by group allocation, and gender), (4) details of acceptability-related outcomes (ie, outcome name, instrument used, and time point of data collection), and (5) results of acceptability-related outcomes. From these data, we noted considerable variation in instruments used to measure acceptability and infrequent use of validated instruments. Acceptability outcome data were therefore narratively synthesized by the direction of acceptability and not by its effect size. The narrative synthesis applied vote counting to the tabulated results, was conducted by the first author (CKYL), and was checked by the last author (BB-A).
+
+Levels of Evidence
+
+Included studies were evaluated using the Oxford Centre for Evidence-Based Medicine–levels of evidence [22]. In this system, each study receives a designation based on a grading classification where 1 is the highest level (randomized controlled trials [RCTs] or systematic reviews of RCTs) and 5 is the lowest (mechanism-based reasoning).
+
+Reported evidence for patient acceptability was further evaluated using an assessment tool designed for this review (Multimedia Appendix 2). The purpose of the assessment tool was to evaluate the quality of acceptability measurement and reporting. An assessment tool was developed because, to our knowledge, one did not already exist. Given the frequency (and variation) with which acceptability is reported as an evaluation outcome, the assessment tool allows summarization of our concerns with the current evidence. The tool emphasizes acquiring and providing sufficient information to evaluate, operationalize, and measure acceptability. Sekhon and colleagues’ [16] recommendation that acceptability be measured at multiple time points informed item 4 of the tool. The assessment tool produces a score ranging from 0 to 15, where scores from 0 to 5 indicate low quality of evidence for patient acceptability, scores 6-10 indicate moderate quality, and scores 11-15 indicate high quality. Assessments using this tool were performed by one author (CKYL) and reviewed by another (BB-A), with discrepancies identified and consensus achieved through discussion.
+
+Risk of Bias
+
+Included studies were individually assessed on aspects of risk of bias using the assessment tool designed for this review (Multimedia Appendix 2). Specifically, the completeness of outcome data and the appropriateness of measurements (ie, selection of instruments) were determined using this assessment tool. These criteria were selected to assess each included study for their direct relevance to the single implementation outcome (ie, acceptability) that is the focus of this review. Preliminary assessments on these criteria indicated a significant risk of bias across the included studies, in terms of incomplete outcome data and low use of validated instruments.
+
+Given these preliminary results suggesting a significant risk of bias, and this review’s focus on a single implementation outcome, risk of bias was assessed using GRADE (Grading of Recommendations, Assessment, Development and Evaluation) [23]. GRADE assesses the quality of evidence for risk of bias across a group of studies in relation to a particular outcome [23]. Across a body of evidence, the risk of bias is assessed as low, unclear, or high [23]. This evaluation was done independently by 2 authors (CKYL and BB-A), with discrepancy resolved with further discussion.
+
+Results
+
+Overview
+
+From the database review process, a total of 2409 articles were identified for screening. Of these articles, 2266 were excluded as they did not meet the inclusion criteria. Included in the review were 143 articles, investigating digital mental health interventions for depression (n=67, 47%), anxiety disorders (n=65, 45%), and a combination of depression and anxiety disorders (n=11, 8%; Figure 1 provides a flow diagram of the review).
+
+Figure 1 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram for each step of the screening process.
+
+In these articles, researchers most often reported on satisfaction as their acceptability-related construct of choice, with satisfaction investigated in 105 (73%) of the 143 included articles. Out of 143 articles, acceptability or acceptance was reported on in 78 (55%) articles, credibility in 26 (18%) articles, expectancy in 20 (14%) articles, and usability in 19 (13%) articles. There were also 21 (15%) articles using such terminology as feedback, experiences, attitudes, subjective appraisal, and subjective benefit.
+
+For the evidence provided for acceptability and its component constructs, the vast majority, at 137 (96%) out of 143 articles, evaluated acceptability “globally” for each digital mental health intervention (ie, across features or components), and 20 (14%) articles assessed acceptability for specific features or components of each digital mental health intervention.
+
+Referring to the component constructs of acceptability identified in Sekhon and colleagues’ [16] theoretical framework, each article investigated a subset of those component constructs. Specifically, out of 143 articles, 121 (85%) investigated affective attitude, 73 (51%) investigated perceived effectiveness, 37 (26%) investigated burden, and 35 (24%) investigated intervention coherence. The remaining component constructs were each investigated in 10% (15/143) or less of the articles (ie, opportunity cost: n=15, 10%; and self-efficacy: n=7, 5%). We did not find any articles that investigated ethicality.
+
+Other constructs that were not explicit components of Sekhon and colleagues’ [16] theoretical framework for acceptability but were investigated in the reviewed articles included perceived quality (17/143, 12%) and acceptability of program tempo or length (10/143, 7%).
+
+In terms of temporal assessments of acceptability or its component constructs, each article captured one or more of prospective acceptability (before the intervention began), concurrent acceptability (during the intervention), and retrospective acceptability (following the intervention), also set out in Sekhon and colleagues’ [16] theoretical framework. Prospective acceptability appeared in 42 (29%) of the 143 articles and concurrent acceptability in 9 (6%) articles. Retrospective acceptability was separated for this review into posttest (125/143, 87%) and follow-up (15/143, 10%). Of the total 143, only 43 (30%) articles contained acceptability assessments for more than 1 time point.
+
+Assessment of Quality
+
+Using our assessment tool for quality of acceptability (Multimedia Appendix 2), articles investigating digital mental health interventions for depression had scores ranging from 2 (low quality of evidence) to 14 (high quality of evidence), out of a total possible 15. The mean score for the quality of evidence for acceptability was 7.3 (SD 2.0). From the information captured with this assessment tool, out of 143 articles, 74 (53%) used one or more validated instruments for acceptability or its component constructs, while 66 (47%) did not use any validated instruments for acceptability or its component constructs.
+
+Risk of Bias
+
+The overall risk of bias was assessed as between high and unclear, considering the predominance of studies that lacked blinding (for RCTs), failed to adequately control confounding, had incomplete accounting of patients and outcome events (particularly losses to follow-up), and other limitations (eg, used measures that are not validated).
+
+Interventions for Depression
+
+From the 67 articles addressing digital mental health interventions for depression, 40 (60%) articles involved web-based programs, 21 (31%) involved mobile apps, and 6 (9%) involved computer-based programs. In terms of treatment modality, 36 (54%) articles explored digital mental health interventions that drew from cognitive behavioral therapy (CBT). These apps or programs were often structured as multimedia modules, with varying levels of clinician or technician support and patient feedback.
+
+The 67 articles investigating digital mental health interventions for depression were comprised of 41 (61%) RCTs, 23 (34%) non-RCT quantitative studies, and 3 (5%) qualitative studies. These studies are reviewed in Table S1 [24-65], Table S2 [66-89], and Table S3 [43,90-92], respectively, in Multimedia Appendix 3. The 64 quantitative studies (RCT and non-RCT) indicated overall positive ratings of acceptability among digital mental health interventions for depression. Among these 64 quantitative studies, we categorized 55 (86%) studies as indicating positive acceptability overall, 6 (9%) studies mixed acceptability, and 3 (5%) studies as having insufficient information to categorize the direction of acceptability. We considered results to be “mixed” if a study had more than 1 acceptability outcome measure and at least 1 positive and 1 negative result. These categorizations are presented in the “Summarized acceptability result” column within each table in Multimedia Appendix 3 [24-92].
+
+The 3 qualitative studies (completed secondarily or subsequently to RCTs) had more mixed results. In 2014, Schneider and colleagues [90] reported that open-ended participant responses on satisfaction levels were more negative than positive, though satisfaction or dissatisfaction were reported as arising from matters related and unrelated to the interventions, such as individual time management choices made during the study. Comments specific to the web-based program were more positive than negative. Knowles and colleagues [91] reported in 2015 that they conducted interviews with participants using digital mental health interventions for depression (MoodGYM [e-hub Health] and Beating the Blues [Manage My Health], both web-based programs in CBT). Responses were coded as positive, negative, or ambivalent toward the digital mental health intervention, with the largest group being ambivalent (17/36 participants, 47%), then negative (10/36 participants, 28%), and then positive (9/36 participants, 25%). Also in 2015, Ly and colleagues [92] held semistructured interviews with participants using a mobile app informed by CBT and mindfulness techniques. Participants’ responses were divided, with 5 (42%) of 12 participants indicating an overall positive experience, 4 (33%) indicating a neutral experience, and 3 (25%) indicating a negative experience.
+
+Interventions for Anxiety Disorders
+
+From the 65 articles addressing digital mental health interventions for anxiety, 52 (80%) articles involved web-based programs, 8 (12%) involved mobile apps, 3 (5%) involved computer-based programs, and 2 (3%) involved others. In terms of treatment modality, 58 (89%) articles explored digital mental health interventions that drew from CBT.
+
+The 65 articles investigating digital mental health interventions for anxiety disorders were comprised of 43 (66%) RCTs and 22 (34%) non-RCT quantitative studies. None were qualitative studies. The studies are reviewed in Table S4 [93-135] and Table S5 [136-157] in Multimedia Appendix 3. In general, the results indicated positive ratings of acceptability. We categorized 59 (91%) studies as indicating positive acceptability overall, 3 (5%) studies mixed acceptability, and 3 (5%) studies as having insufficient information to categorize the direction of acceptability. We considered results to be “mixed” if a study had more than 1 acceptability outcome measure and at least 1 positive and 1 negative result. These categorizations are presented in the “Summarized acceptability result” column within each table in Multimedia Appendix 3 [93-157].
+
+Interventions for Depression and Anxiety Disorders Together
+
+Among the 11 articles addressing digital mental health interventions for both depression and anxiety disorders, 8 (73%) articles involved web-based programs, 2 (18%) involved mobile apps, and 1 (9%) involved computer-based programs. In terms of treatment modality, 8 (73%) articles explored digital mental health interventions that drew from CBT.
+
+The 11 articles investigating digital mental health interventions for both depression and anxiety disorders were comprised of 6 (55%) RCTs and 5 (45%) non-RCT quantitative studies (reviewed in Table S6 [158-163] and Table S7 [164-168] in Multimedia Appendix 3). None were qualitative studies. In general, the results indicated positive ratings of acceptability. We categorized all 11 studies as indicating positive acceptability overall, with none that indicated mixed results or insufficient information to categorize the direction of acceptability. These categorizations are presented in the “Summarized acceptability result” column within each table in Multimedia Appendix 3 [158-168].
+
+Discussion
+
+Principal Findings
+
+Digital mental health interventions for depression and anxiety disorders were generally found to be acceptable to patients. Of the 143 included articles, 125 (87%) indicated positive acceptability, 12 (9%) had mixed results, and 6 had insufficient information (4%). These results arose out of evidence generated primarily from RCTs (90/143, 63%) and other quantitative studies (50/143, 35%), and largely investigations of web-based apps (100/143, 70%) and CBT-based content (102/143, 71%). These findings came primarily from views on a digital mental health intervention as a whole (137/143, 96%) rather than specific features, and centered on patient satisfaction (105/143, 73%) or Sekhon and colleagues’ [16] “affective attitude” (121/143, 85%) at posttest (125/143, 87%). We noted no substantial differences in the acceptability noted for digital mental health interventions for depression, anxiety, or depression and anxiety together.
+
+Our findings suggest some receptiveness among those with depression or anxiety disorders to digital mental health interventions. If the overall positive experience of digital mental health interventions translates into patient adherence to and engagement with treatment, digital mental health interventions can improve patient access to care and expand the capacity of health systems. Since some patients appear open to digital mental health interventions, clinicians can explore patients’ views on these technologies in the course of treatment planning and respond accordingly. Researchers can further our understanding by investigating patient and intervention characteristics that predict or improve acceptance and deepen our understanding of acceptability beyond satisfaction or affective attitudes. Developers can recognize the potential in continuing to invest in digital mental health interventions and take steps to improve user experiences and strengthen acceptability.
+
+The findings of positive acceptability toward digital mental health interventions must nevertheless be qualified by gaps in the existing research.
+
+First, the assessment tool revealed that studies had a wide range in quality of acceptability-related evidence and were generally only of moderate quality. This finding suggests a need to increase standardization of acceptability assessments. We propose that our assessment tool be used as a checklist when planning evaluation research. The results outlined above indicate that there is an opportunity to use validated measures for acceptability, measure acceptability at different time points, and consider measures that address multiple acceptability components.
+
+The second gap is the continued absence of a consensus definition for acceptability. As an example, Sekhon and colleagues [16] make clear that satisfaction ought to be treated as a construct separate from acceptability, but many studies continue to use satisfaction as an indicator of acceptability, or otherwise consider satisfaction alone when perhaps the construct of interest is acceptability. Similarly, Sekhon and colleagues [16] identified 7 component constructs of acceptability, but studies are generally designed to address only some of these components and vary by the components chosen. These findings suggest that there may not only be variation in how acceptability is investigated, but also variation in how acceptability is understood. It is necessary to establish a consensus on how acceptability should be defined, to increase the consistency and relevance of future acceptability research.
+
+Third, some aspects of acceptability such as affective attitude and perceived effectiveness were more frequently investigated, while other aspects were far less likely to be explored, particularly ethicality, self-efficacy, and opportunity cost. Likely, this relates to some component constructs being considered more important than others, or the feasibility of investigating some component constructs over others. Investigating all components of acceptability is important to better understand how users relate to digital mental health interventions.
+
+Finally, we noted a paucity of research on how acceptability changes over time, with most studies examining only retrospective acceptability. Evaluating acceptability as a variable that is continuous and changeable over time would enhance development processes for digital mental health interventions. It would allow us to identify the modifications that can be made to a technology to strengthen acceptability at different stages, to increase willingness to initiate use of a digital mental health intervention, to continue using it, and to use it as frequently or often as is needed to reap therapeutic benefits.
+
+Limitations
+
+An important limitation of research on acceptability, as identified in the risk of bias assessment, lies with evidence generally being provided by patients who have agreed to use the digital mental health intervention and continued to engage with the study or the digital mental health intervention. Often missing from these findings is the acceptability of digital mental health interventions among individuals who had the opportunity to participate in a study involving a digital mental health intervention but chose not to. Nonparticipation and early termination in digital health have long prompted calls for more research attention on attrition, for example, Eysenbach [169] in 2005, along with related constructs such as adherence and engagement. There remains a need to establish consensus approaches to analyzing attrition, adherence, and engagement [170], and their relationship with acceptability. It is recommended that appropriate methods for such analyses be developed, to be used consistently in future evaluations of digital mental health interventions.
+
+A second limitation comes from potential conflict in the research evidence between the acceptability of the intervention technology and the acceptability of the intervention as a whole. Future research should differentiate acceptability of the technology from the acceptability of other aspects, such as the timing or pacing of the intervention, or the treatment paradigm applied.
+
+A further limitation is that the terminology used to identify acceptability is varied and changeable between studies. Data on acceptability not labelled as such may be difficult to integrate into acceptability research at large.
+
+Finally, literature on this topic has increased exponentially following the COVID-19 pandemic [171]. Any review can only represent a snapshot of the available research at a point in time. At the same time, despite this proliferation of research, diverse populations (in terms of ethnicity, income and education levels, sexual and gender minority status, etc) remain underrepresented [172]. More evaluation studies are needed that ensure their inclusion and provide demographic data as appropriate, to further our understanding of their acceptability of digital mental health interventions.
+
+Conclusions
+
+There is evidence for the acceptability of digital mental health interventions among patients with depression or anxiety disorders, with most studies in this review indicating positive acceptability. However, the available research evidence for acceptability is, as a whole, of only moderate quality. It is suggested that future intervention studies be planned from the outset to produce higher quality evidence for acceptability. Enhanced research evidence for acceptability will provide better insights into the appropriateness of digital mental health interventions for patients with depression or anxiety disorders.
+
+Support was provided by Emily Stowe Society funding at Women’s College Hospital Foundation (a nonprofit foundation).
+
+Multimedia Appendix 1 Search strategies.
+
+Multimedia Appendix 2 Acceptability assessment tool.
+
+Multimedia Appendix 3 Description of acceptability results in the included studies.
+
+Multimedia Appendix 4 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 checklist.
+
+Multimedia Appendix 5 PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 checklist for abstracts.
+
+Abbreviations
+
+CBT cognitive behavioral therapy
+
+GRADE Grading of Recommendations, Assessment, Development and Evaluation
+
+MeSH Medical Subject Headings
+
+PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses
+
+PROSPERO International Prospective Register of Systematic Reviews
+
+RCT randomized controlled trial
+
+Authors' Contributions: Each author contributed substantially to this work. BB-A conceived of the review and all other authors provided feedback on the design. CKYL, AS, BC, and DR were involved in data collection. All authors participated in data analysis and interpretation. BB-A and CKYL wrote the initial draft of the paper. All authors contributed to revisions of the manuscript. All authors read and approved the final submitted manuscript.
+
+Conflicts of Interest: None declared.
+
+
+1 Report from the Canadian Chronic Disease Surveillance System: Mood and Anxiety Disorders in Canada, 2016 Public Health Agency of Canada 2016 2023-07-08 https://www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/diseases-conditions-maladies-affections/mood-anxiety-disorders-2016-troubles-anxieux-humeur/alt/mood-anxiety-disorders-2016-troubles-anxieux-humeur-eng.pdf
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+51 Perini S Titov N Andrews G Clinician-assisted internet-based treatment is effective for depression: randomized controlled trial Aust N Z J Psychiatry 2009 06 43 6 571 8 10.1080/00048670902873722 19440890 911151658 19440890
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+58 Titov N Dear BF Staples LG Terides MD Karin E Sheehan J Johnston L Gandy M Fogliati VJ Wootton BM McEvoy PM Disorder-specific versus transdiagnostic and clinician-guided versus self-guided treatment for major depressive disorder and comorbid anxiety disorders: a randomized controlled trial J Anxiety Disord 2015 10 35 88 102 10.1016/j.janxdis.2015.08.002 26422822 S0887-6185(15)30008-6 26422822
+59 Titov N Andrews G Davies M McIntyre K Robinson E Solley K Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance PLoS One 2010 06 08 5 6 e10939 10.1371/journal.pone.0010939 20544030 20544030 PMC2882336
+60 Tønning Morten Lindbjerg Faurholt-Jepsen M Frost M Martiny K Tuxen N Rosenberg N Busk J Winther O Melbye SA Thaysen-Petersen D Aamund KA Tolderlund L Bardram JE Kessing LV The effect of smartphone-based monitoring and treatment on the rate and duration of psychiatric readmission in patients with unipolar depressive disorder: The RADMIS randomized controlled trial J Affect Disord 2021 03 01 282 354 363 10.1016/j.jad.2020.12.141 33421863 S0165-0327(20)33231-6 33421863
+61 Wahbeh H Internet mindfulness meditation intervention (IMMI) improves depression symptoms in older adults Medicines (Basel) 2018 11 02 5 4 119 10.3390/medicines5040119 30400211 medicines5040119 30400211 PMC6313401
+62 Watts S Mackenzie A Thomas C Griskaitis A Mewton L Williams A Andrews G CBT for depression: a pilot RCT comparing mobile phone vs. computer BMC Psychiatry 2013 02 07 13 49 10.1186/1471-244X-13-49 23391304 1471-244X-13-49 23391304 PMC3571935
+63 Williams AD Blackwell SE Mackenzie A Holmes EA Andrews G Combining imagination and reason in the treatment of depression: a randomized controlled trial of internet-based cognitive-bias modification and internet-CBT for depression J Consult Clin Psychol 2013 10 81 5 793 9 10.1037/a0033247 23750459 2013-20188-001 23750459 PMC3780629
+64 Williams AD O'Moore K Blackwell SE Smith J Holmes EA Andrews G Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioral therapy (iCBT): a randomized controlled trial J Affect Disord 2015 06 01 178 131 41 10.1016/j.jad.2015.02.026 25805405 S0165-0327(15)00119-6 25805405 PMC4407900
+65 Wong VWH Ho FYY Shi NK Tong JTY Chung KF Yeung WF Ng CH Oliver G Sarris J Smartphone-delivered multicomponent lifestyle medicine intervention for depressive symptoms: a randomized controlled trial J Consult Clin Psychol 2021 12 89 12 970 984 10.1037/ccp0000695 35025538 2022-22669-002 35025538
+66 Addington EL Cheung EO Bassett SM Kwok I Schuette SA Shiu E Yang D Cohn MA Leykin Y Saslow LR Moskowitz JT The MARIGOLD study: feasibility and enhancement of an online intervention to improve emotion regulation in people with elevated depressive symptoms J Affect Disord 2019 10 01 257 352 364 10.1016/j.jad.2019.07.049 31302525 S0165-0327(18)33251-8 31302525 PMC6711819
+67 Berman MI Buckey JC Hull JG Linardatos E Song SL McLellan RK Hegel MT Feasibility study of an interactive multimedia electronic problem solving treatment program for depression: a preliminary uncontrolled trial Behav Ther 2014 05 45 3 358 75 10.1016/j.beth.2014.02.001 24680231 S0005-7894(14)00024-0 24680231 PMC4003894
+68 Burns MN Begale M Duffecy J Gergle D Karr CJ Giangrande E Mohr DC Harnessing context sensing to develop a mobile intervention for depression J Med Internet Res 2011 08 12 13 3 e55 10.2196/jmir.1838 21840837 v13i3e55 21840837 PMC3222181
+69 Callan JA Dunbar Jacob J Siegle GJ Dey A Thase ME DeVito Dabbs A Kazantzis N Rotondi A Tamres L van Slyke A Sereika S CBT MobileWork©: user-centered development and testing of a mobile mental health application for depression Cogn Ther Res 2020 09 25 45 2 287 302 10.1007/s10608-020-10159-4
+70 Caplan S Sosa Lovera A Reyna Liberato P A feasibility study of a mental health mobile app in the Dominican Republic: the untold story International Journal of Mental Health 2019 04 04 47 4 311 345 10.1080/00207411.2018.1553486
+71 Cartreine JA Locke SE Buckey JC Sandoval L Hegel MT Electronic problem-solving treatment: description and pilot study of an interactive media treatment for depression JMIR Res Protoc 2012 09 25 1 2 e11 10.2196/resprot.1925 23611902 v1i2e11 23611902 PMC3626146
+72 Coutinho E Alshukri A de Berardinis J Dowrick C POLYHYMNIA mood – empowering people to cope with depression through music listening 2021 Adjunct Proceedings of the 2021 ACM International Joint Conference on Pervasive and Ubiquitous Computing and Proceedings of the 2021 ACM International Symposium on Wearable Computers September 24, 2021 Virtual event 188 193 10.1145/3460418.3479334
+73 Dahne J Kustanowitz J Lejuez CW Development and preliminary feasibility study of a brief behavioral activation mobile application (Behavioral Apptivation) to be used in conjunction with ongoing therapy Cogn Behav Pract 2018 02 25 1 44 56 10.1016/j.cbpra.2017.05.004 29725198 29725198 PMC5926244
+74 Dear BF Zou J Titov N Lorian C Johnston L Spence J Anderson T Sachdev P Brodaty H Knight RG Internet-delivered cognitive behavioural therapy for depression: a feasibility open trial for older adults Aust N Z J Psychiatry 2013 02 47 2 169 76 10.1177/0004867412466154 23152358 0004867412466154 23152358
+75 Drake G Csipke E Wykes T Assessing your mood online: acceptability and use of Moodscope Psychol Med 2013 07 43 7 1455 64 10.1017/S0033291712002280 23149120 S0033291712002280 23149120 PMC3683895
+76 Fuller-Tyszkiewicz M Richardson B Klein B Skouteris H Christensen H Austin D Castle D Mihalopoulos C O'Donnell R Arulkadacham L Shatte A Ware A A mobile app-based intervention for depression: end-user and expert usability testing study JMIR Ment Health 2018 08 23 5 3 e54 10.2196/mental.9445 30139722 v5i3e54 30139722 PMC6127496
+77 Gould CE Carlson C Ma F Forman-Hoffman V Ranta K Kuhn E Effects of mobile app-based intervention for depression in middle-aged and older adults: mixed methods feasibility study JMIR Form Res 2021 06 29 5 6 e25808 10.2196/25808 34185000 v5i6e25808 34185000 PMC8278301
+78 Harper Shehadeh MJ Abi Ramia J Cuijpers P El Chammay R Heim E Kheir W Saeed K van Ommeren M Van't Hof E Watts S Wenger A Zoghbi E Carswell K Step-by-step, an e-mental health intervention for depression: a mixed methods pilot study from Lebanon Front Psychiatry 2019 10 986 10.3389/fpsyt.2019.00986 32116815 32116815 PMC7034323
+79 Jacmon J Malouff J Taylor N Treatment of major depression: effectiveness of cognitive behavior therapy with an internet course as a central component E-J Appl Psychol 2010 5 2 1 8
+80 Kooistra LC Ruwaard J Wiersma JE van Oppen P van der Vaart R van Gemert-Pijnen JE Riper H Development and initial evaluation of blended cognitive behavioural treatment for major depression in routine specialized mental health care Internet Interv 2016 05 4 61 71 10.1016/j.invent.2016.01.003 30135791 S2214-7829(16)00003-8 30135791 PMC6096194
+81 Mayer G Hummel S Oetjen N Gronewold N Bubolz S Blankenhagel K Slawik M Zarnekow R Hilbel T Schultz J User experience and acceptance of patients and healthy adults testing a personalized self-management app for depression: a non-randomized mixed-methods feasibility study Digit Health 2022 8 20552076221091353 10.1177/20552076221091353 35425641 10.1177_20552076221091353 35425641 PMC9003643
+82 Schlosser DA Campellone TR Truong B Anguera JA Vergani S Vinogradov S Arean P The feasibility, acceptability, and outcomes of PRIME-D: a novel mobile intervention treatment for depression Depress Anxiety 2017 06 34 6 546 554 10.1002/da.22624 28419621 28419621 PMC5634707
+83 Schuster R Kalthoff I Walther A Köhldorfer Lena Partinger E Berger T Laireiter AR Effects, adherence, and therapists' perceptions of web- and mobile-supported group therapy for depression: mixed-methods study J Med Internet Res 2019 04 28 21 5 e11860 10.2196/11860 31066700 v21i5e11860 31066700 PMC6533044
+84 Stiles-Shields C Montague E Kwasny MJ Mohr DC Behavioral and cognitive intervention strategies delivered via coached apps for depression: Pilot trial Psychol Serv 2019 05 16 2 233 238 10.1037/ser0000261 30407055 2018-56150-001 30407055 PMC6499699
+85 Strauss C Dunkeld C Cavanagh K Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study Internet Interv 2021 09 25 100413 10.1016/j.invent.2021.100413 34401372 S2214-7829(21)00053-1 34401372 PMC8350580
+86 Elliott R Slatick E Urman M Qualitative change process research on psychotherapy: alternative strategies Psychologische Beitrage 2001 43 3 69 111
+87 Tomasino KN Lattie EG Ho J Palac HL Kaiser SM Mohr DC Harnessing peer support in an online intervention for older adults with depression Am J Geriatr Psychiatry 2017 10 25 10 1109 1119 10.1016/j.jagp.2017.04.015 28571785 S1064-7481(17)30308-1 28571785 PMC5600661
+88 Walsh SM Development of an online intervention using positive psychology for depression Queen Mary University of London 2018 2024-09-17 UK http://qmro.qmul.ac.uk/xmlui/handle/123456789/31871
+89 Yeung A Wang F Feng F Zhang J Cooper A Hong L Wang W Griffiths K Bennett K Bennett A Alpert J Fava M Outcomes of an online computerized cognitive behavioral treatment program for treating Chinese patients with depression: a pilot study Asian J Psychiatr 2018 12 38 102 107 10.1016/j.ajp.2017.11.007 29146042 S1876-2018(17)30209-5 29146042
+90 Schneider J Sarrami Foroushani P Grime P Thornicroft G Acceptability of online self-help to people with depression: users' views of MoodGYM versus informational websites J Med Internet Res 2014 03 28 16 3 e90 10.2196/jmir.2871 24681717 v16i3e90 24681717 PMC4004160
+91 Knowles SE Lovell K Bower P Gilbody S Littlewood E Lester H Patient experience of computerised therapy for depression in primary care BMJ Open 2015 11 30 5 11 e008581 10.1136/bmjopen-2015-008581 26621513 bmjopen-2015-008581 PMC4679833 26621513
+92 Ly KH Janni E Wrede R Sedem M Donker T Carlbring P Andersson G Experiences of a guided smartphone-based behavioral activation therapy for depression: a qualitative study Internet Interventions 2015 03 2 1 60 68 10.1016/j.invent.2014.12.002
+93 Allen AR Newby JM Mackenzie A Smith J Boulton M Loughnan SA Andrews G Internet cognitive-behavioural treatment for panic disorder: randomised controlled trial and evidence of effectiveness in primary care BJPsych Open 2016 03 2 2 154 162 10.1192/bjpo.bp.115.001826 27703768 S2056472400001290 27703768 PMC4998930
+94 Bell CJ Colhoun HC Carter FA Frampton CM Effectiveness of computerised cognitive behaviour therapy for anxiety disorders in secondary care Aust N Z J Psychiatry 2012 07 46 7 630 40 10.1177/0004867412437345 22327097 0004867412437345 22327097
+95 Berger T Hohl E Caspar F Internet-based treatment for social phobia: a randomized controlled trial J Clin Psychol 2009 10 65 10 1021 35 10.1002/jclp.20603 19437505 19437505
+96 Berger T Caspar F Richardson R Kneubühler Bernhard Sutter D Andersson G Internet-based treatment of social phobia: a randomized controlled trial comparing unguided with two types of guided self-help Behav Res Ther 2011 03 49 3 158 69 10.1016/j.brat.2010.12.007 21255767 S0005-7967(10)00256-1 21255767
+97 Berger T Boettcher J Caspar F Internet-based guided self-help for several anxiety disorders: a randomized controlled trial comparing a tailored with a standardized disorder-specific approach Psychotherapy (Chic) 2014 06 51 2 207 19 10.1037/a0032527 24041199 2013-32697-001 24041199
+98 Boettcher J Leek L Matson L Holmes EA Browning M MacLeod C Andersson G Carlbring P Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues PLoS One 2013 8 9 e71760 10.1371/journal.pone.0071760 24098630 PONE-D-13-11999 24098630 PMC3787061
+99 Boettcher J Aström Viktor Påhlsson Daniel Schenström Ola Andersson G Carlbring P Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial Behav Ther 2014 03 45 2 241 53 10.1016/j.beth.2013.11.003 24491199 S0005-7894(13)00104-4 24491199
+100 Boettcher J Hasselrot J Sund E Andersson G Carlbring P Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial Cogn Behav Ther 2014 43 1 34 48 10.1080/16506073.2013.809141 23898817 23898817 PMC3869050
+101 Carlbring P Westling BE Ljungstrand P Ekselius L Andersson G Treatment of panic disorder via the internet: a randomized trial of a self-help program Behavior Therapy 2001 32 4 751 764 10.1016/S0005-7894(01)80019-8
+102 Carlbring P Ekselius L Andersson G Treatment of panic disorder via the Internet: a randomized trial of CBT vs. applied relaxation J Behav Ther Exp Psychiatry 2003 06 34 2 129 40 10.1016/s0005-7916(03)00026-0 12899896 S0005791603000260 12899896
+103 Carlbring P Nilsson-Ihrfelt E Waara J Kollenstam C Buhrman M Kaldo V Söderberg Marie Ekselius L Andersson G Treatment of panic disorder: live therapy vs. self-help via the internet Behav Res Ther 2005 10 43 10 1321 33 10.1016/j.brat.2004.10.002 16086983 S0005-7967(04)00237-2 16086983
+104 Carlbring P Bohman S Brunt S Buhrman M Westling BE Ekselius L Andersson G Remote treatment of panic disorder: a randomized trial of internet-based cognitive behavior therapy supplemented with telephone calls Am J Psychiatry 2006 12 163 12 2119 25 10.1176/ajp.2006.163.12.2119 17151163 163/12/2119 17151163
+105 Carter FA Bell CJ Colhoun HC Suitability and acceptability of computerised cognitive behaviour therapy for anxiety disorders in secondary care Aust N Z J Psychiatry 2013 02 47 2 142 52 10.1177/0004867412461384 23047956 0004867412461384 23047956
+106 Dear BF Staples LG Terides MD Karin E Zou J Johnston L Gandy M Fogliati VJ Wootton BM McEvoy PM Titov N Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for generalized anxiety disorder and comorbid disorders: a randomized controlled trial J Anxiety Disord 2015 12 36 63 77 10.1016/j.janxdis.2015.09.003 26460536 S0887-6185(15)30013-X 26460536
+107 Dear BF Staples LG Terides MD Fogliati VJ Sheehan J Johnston L Kayrouz R Dear R McEvoy PM Titov N Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for Social Anxiety Disorder and comorbid disorders: a randomized controlled trial J Anxiety Disord 2016 08 42 30 44 10.1016/j.janxdis.2016.05.004 27261562 S0887-6185(16)30063-9 27261562
+108 Ebenfeld L Lehr D Ebert DD Kleine Stegemann S Riper H Funk B Berking M Evaluating a hybrid web-based training program for panic disorder and agoraphobia: randomized controlled trial J Med Internet Res 2021 03 04 23 3 e20829 10.2196/20829 33661121 v23i3e20829 33661121 PMC7974752
+109 Fogliati VJ Dear BF Staples LG Terides MD Sheehan J Johnston L Kayrouz R Dear R McEvoy PM Titov N Disorder-specific versus transdiagnostic and clinician-guided versus self-guided internet-delivered treatment for panic disorder and comorbid disorders: a randomized controlled trial J Anxiety Disord 2016 04 39 88 102 10.1016/j.janxdis.2016.03.005 27003376 S0887-6185(16)30034-2 27003376
+110 Furmark T Carlbring P Hedman E Sonnenstein A Clevberger P Bohman B Eriksson A Hållén Agneta Frykman M Holmström Annelie Sparthan E Tillfors M Ihrfelt EN Spak M Eriksson A Ekselius L Andersson G Guided and unguided self-help for social anxiety disorder: randomised controlled trial Br J Psychiatry 2009 11 195 5 440 7 10.1192/bjp.bp.108.060996 19880935 S0007125000250952 19880935
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+113 Johnston L Titov N Andrews G Spence J Dear BF A RCT of a transdiagnostic internet-delivered treatment for three anxiety disorders: examination of support roles and disorder-specific outcomes PLoS One 2011 6 11 e28079 10.1371/journal.pone.0028079 22132216 PONE-D-11-04313 22132216 PMC3223218
+114 Johnston L Development and evaluation of a transdiagnostic internet-delivered cognitive behavioural therapy program for three anxiety disorders [Thesis] UNSW Sydney 2012 2024-10-14 http://hdl.handle.net/1959.4/52139
+115 Jones SL Hadjistavropoulos HD Soucy JN A randomized controlled trial of guided internet-delivered cognitive behaviour therapy for older adults with generalized anxiety J Anxiety Disord 2016 01 37 1 9 10.1016/j.janxdis.2015.10.006 26561733 S0887-6185(15)30029-3 26561733
+116 Kiropoulos LA Klein B Austin DW Gilson K Pier C Mitchell J Ciechomski L Is internet-based CBT for panic disorder and agoraphobia as effective as face-to-face CBT? J Anxiety Disord 2008 12 22 8 1273 84 10.1016/j.janxdis.2008.01.008 18289829 S0887-6185(08)00017-0 18289829
+117 Klein B Richards JC Austin DW Efficacy of internet therapy for panic disorder J Behav Ther Exp Psychiatry 2006 09 37 3 213 38 10.1016/j.jbtep.2005.07.001 16126161 S0005-7916(05)00045-5 16126161
+118 Klein B Austin D Pier C Kiropoulos L Shandley K Mitchell J Gilson K Ciechomski L Internet-based treatment for panic disorder: does frequency of therapist contact make a difference? Cogn Behav Ther 2009 38 2 100 13 10.1080/16506070802561132 19306149 909723917 19306149
+119 Kok RN van Straten A Beekman ATF Cuijpers P Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial J Med Internet Res 2014 09 29 16 9 e226 10.2196/jmir.3429 25266929 v16i9e226 25266929 PMC4211034
+120 Pham Q Khatib Y Stansfeld S Fox S Green T Feasibility and efficacy of an mHealth game for managing anxiety: "Flowy" randomized controlled pilot trial and design evaluation Games Health J 2016 02 5 1 50 67 10.1089/g4h.2015.0033 26536488 26536488
+121 Robinson E Titov N Andrews G McIntyre K Schwencke G Solley K Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance PLoS One 2010 06 03 5 6 e10942 10.1371/journal.pone.0010942 20532167 20532167 PMC2880592
+122 Ruwaard J Broeksteeg J Schrieken B Emmelkamp P Lange A Web-based therapist-assisted cognitive behavioral treatment of panic symptoms: a randomized controlled trial with a three-year follow-up J Anxiety Disord 2010 05 24 4 387 96 10.1016/j.janxdis.2010.01.010 20227241 S0887-6185(10)00027-7 20227241
+123 Schneider AJ Mataix-Cols D Marks IM Bachofen M Internet-guided self-help with or without exposure therapy for phobic and panic disorders Psychother Psychosom 2005 74 3 154 64 10.1159/000084000 15832066 84000 15832066
+124 Schröder Johanna Jelinek L Moritz S A randomized controlled trial of a transdiagnostic Internet intervention for individuals with panic and phobias - one size fits all J Behav Ther Exp Psychiatry 2017 03 54 17 24 10.1016/j.jbtep.2016.05.002 27227651 S0005-7916(16)30095-7 27227651
+125 Stech EP Chen AZ Sharrock MJ Grierson AB Upton EL Mahoney AEJ Grisham JR Newby JM Internet-delivered exposure therapy versus internet-delivered cognitive behavioral therapy for panic disorder: A pilot randomized controlled trial J Anxiety Disord 2021 04 79 102382 10.1016/j.janxdis.2021.102382 33774558 S0887-6185(21)00029-3 33774558
+126 Titov N Andrews G Schwencke G Drobny J Einstein D Shyness 1: distance treatment of social phobia over the Internet Aust N Z J Psychiatry 2008 07 42 7 585 94 10.1080/00048670802119762 18612862 794820327 18612862
+127 Titov N Andrews G Schwencke G Shyness 2: treating social phobia online: replication and extension Aust N Z J Psychiatry 2008 07 42 7 595 605 10.1080/00048670802119820 18612863 794820392 18612863
+128 Titov N Andrews G Choi I Schwencke G Mahoney A Shyness 3: randomized controlled trial of guided versus unguided Internet-based CBT for social phobia Aust N Z J Psychiatry 2008 12 42 12 1030 40 10.1080/00048670802512107 19016091 905606265 19016091
+129 Titov N Andrews G Johnston L Schwencke G Choi I Shyness programme: longer term benefits, cost-effectiveness, and acceptability Aust N Z J Psychiatry 2009 01 43 1 36 44 10.1080/00048670802534424 19085526 906738278 19085526
+130 Titov N Andrews G Choi I Schwencke G Johnston L Randomized controlled trial of web-based treatment of social phobia without clinician guidance Aust N Z J Psychiatry 2009 01 01 43 10 913 919 10.1080/00048670903179160
+131 Titov N Andrews G Schwencke G Solley K Johnston L Robinson E An RCT comparing effect of two types of support on severity of symptoms for people completing internet-based cognitive behaviour therapy for social phobia Aust N Z J Psychiatry 2009 01 01 43 10 920 926 10.1080/00048670903179228
+132 Titov N Andrews G Robinson E Schwencke G Johnston L Solley K Choi I Clinician-assisted internet-based treatment is effective for generalized anxiety disorder: randomized controlled trial Aust N Z J Psychiatry 2009 01 01 43 10 905 912 10.1080/00048670903179269
+133 Titov N Andrews G Johnston L Robinson E Spence J Transdiagnostic Internet treatment for anxiety disorders: a randomized controlled trial Behav Res Ther 2010 09 48 9 890 9 10.1016/j.brat.2010.05.014 20561606 S0005-7967(10)00110-5 20561606
+134 Titov N Andrews G Schwencke G Robinson E Peters L Spence J Randomized controlled trial of Internet cognitive behavioural treatment for social phobia with and without motivational enhancement strategies Aust N Z J Psychiatry 2010 10 44 10 938 45 10.3109/00048674.2010.493859 20932208 20932208
+135 Tulbure BT Szentagotai A David O Ștefan S Månsson Kristoffer N T David D Andersson G Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial PLoS One 2015 10 5 e0123997 10.1371/journal.pone.0123997 25938241 PONE-D-14-39593 25938241 PMC4418823
+136 Aydos L Titov N Andrews G Shyness 5: the clinical effectiveness of Internet-based clinician-assisted treatment of social phobia Australas Psychiatry 2009 12 17 6 488 492 10.1080/10398560903284943 20001373 20001373
+137 Botella C Gallego M Garcia-Palacios A Baños R Quero S Alcañiz M The acceptability of an Internet-based self-help treatment for fear of public speaking British Journal of Guidance & Counselling 2009 08 37 3 297 311 10.1080/03069880902957023
+138 Botella C Guillen V Banos RM García-Palacios A Gallego MJ Alcaniz M Telepsychology and self-help: the treatment of fear of public speaking Cognitive and Behavioral Practice 2007 2 14 1 46 57 10.1016/j.cbpra.2006.01.007
+139 Botella C Hofmann SG Moscovitch DA A self-applied, internet-based intervention for fear of public speaking J Clin Psychol 2004 08 60 8 821 30 10.1002/jclp.20040 15241810 15241810
+140 Carlbring P Furmark T Steczkó J Ekselius L Andersson G An open study of Internet-based bibliotherapy with minimal therapist contact via email for social phobia Clinical Psychologist 2007 02 03 10 1 30 38 10.1080/13284200500378662
+141 Draper M Rees CS Nathan PR Internet-based self-management of generalised anxiety disorder: a preliminary study Behav. change 2012 02 22 25 4 229 244 10.1375/bech.25.4.229
+142 Ebenfeld L Kleine Stegemann S Lehr D Ebert DD Funk B Riper H Berking M A mobile application for panic disorder and agoraphobia: insights from a multi-methods feasibility study Internet Interv 2020 03 19 100296 10.1016/j.invent.2019.100296 31890640 S2214-7829(19)30018-1 31890640 PMC6926267
+143 Gruber K Moran PJ Roth WT Taylor CB Computer-assisted cognitive behavioral group therapy for social phobia Behavior Therapy 2001 32 1 155 165 10.1016/S0005-7894(01)80050-2
+144 Kenardy JA Dow MGT Johnston DW Newman MG Thomson A Taylor CB A comparison of delivery methods of cognitive-behavioral therapy for panic disorder: an international multicenter trial J Consult Clin Psychol 2003 12 71 6 1068 75 10.1037/0022-006X.71.6.1068 14622082 2003-09784-012 14622082
+145 Kenwright M Marks IM Gega L Mataix-Cols D Computer-aided self-help for phobia/panic via internet at home: a pilot study Br J Psychiatry 2004 05 184 448 9 10.1192/bjp.184.5.448 15123511 S0007125000163986 15123511
+146 Klein B Shandley K Austin D Nordin S A pilot trial of ‘Panic Online’ as a self-guided treatment for panic disorder EJ Appl Psychol 2008 4 2 25 30 10.7790/ejap.v4i2.136
+147 Krafft J Ong CW Davis CH Petersen JM Levin ME Twohig MP An open trial of group acceptance and commitment therapy with an adjunctive mobile app for generalized anxiety disorder Cognitive and Behavioral Practice 2022 11 29 4 846 859 10.1016/j.cbpra.2021.05.008
+148 Lim MH Rodebaugh TL Eres R Long KM Penn DL Gleeson JFM A pilot digital intervention targeting loneliness in youth mental health Front Psychiatry 2019 10 604 10.3389/fpsyt.2019.00604 31507469 31507469 PMC6716464
+149 Loo Gee B Batterham PJ Gulliver A Reynolds J Griffiths KM An ecological momentary intervention for people with social anxiety: a descriptive case study Inform Health Soc Care 2021 12 02 46 4 370 398 10.1080/17538157.2021.1896525 33779480 33779480
+150 Miller CB Gu J Henry AL Davis ML Espie CA Stott R Heinz AJ Bentley KH Goodwin GM Gorman BS Craske MG Carl JR Feasibility and efficacy of a digital CBT intervention for symptoms of generalized anxiety disorder: a randomized multiple-baseline study J Behav Ther Exp Psychiatry 2021 03 70 101609 10.1016/j.jbtep.2020.101609 32950939 S0005-7916(19)30269-1 32950939
+151 Miralles I Granell C García-Palacios A Castilla D González-Pérez A Casteleyn S Bretón-López J Enhancing in vivo exposure in the treatment of panic disorder and agoraphobia using location-based technologies: a case study Clinical Case Studies 2019 12 20 19 2 145 159 10.1177/1534650119892900
+152 Newman MG Kenardy J Herman S Taylor CB Comparison of palmtop-computer-assisted brief cognitive-behavioral treatment to cognitive-behavioral treatment for panic disorder J Consult Clin Psychol 1997 02 65 1 178 83 10.1037//0022-006x.65.1.178 9103747 9103747
+153 Oser M Wallace ML Solano F Szigethy EM Guided digital cognitive behavioral program for anxiety in primary care: propensity-matched controlled trial JMIR Ment Health 2019 04 04 6 4 e11981 10.2196/11981 30946022 v6i4e11981 30946022 PMC6470461
+154 Pier C Austin DW Klein B Mitchell J Schattner P Ciechomski L Gilson KJ Pierce D Shandley K Wade V A controlled trial of internet-based cognitive-behavioural therapy for panic disorder with face-to-face support from a general practitioner or email support from a psychologist Ment Health Fam Med 2008 03 5 1 29 39 22477844 22477844 PMC2777548
+155 Shandley K Austin DW Klein B Pier C Schattner P Pierce D Wade V Therapist-assisted, Internet-based treatment for panic disorder: can general practitioners achieve comparable patient outcomes to psychologists? J Med Internet Res 2008 05 19 10 2 e14 10.2196/jmir.1033 18487138 v10i2e14 18487138 PMC2483919
+156 Tolin DF McGrath PB Hale LR Weiner DN Gueorguieva R A multisite benchmarking trial of capnometry guided respiratory intervention for panic disorder in naturalistic treatment settings Appl Psychophysiol Biofeedback 2017 03 42 1 51 58 10.1007/s10484-017-9354-4 28194546 10.1007/s10484-017-9354-4 28194546 PMC5344940
+157 Williams AD O'Moore K Mason E Andrews G The effectiveness of internet cognitive behaviour therapy (iCBT) for social anxiety disorder across two routine practice pathways Internet Interventions 2014 10 1 4 225 229 10.1016/j.invent.2014.11.001
+158 Batterham PJ Calear AL Sunderland M Kay-Lambkin F Farrer LM Christensen H Gulliver A A brief intervention to increase uptake and adherence of an internet-based program for depression and anxiety (enhancing engagement with psychosocial interventions): randomized controlled trial J Med Internet Res 2021 07 27 23 7 e23029 10.2196/23029 34313595 v23i7e23029 34313595 PMC8367139
+159 Kleiboer A Donker T Seekles W van Straten A Riper H Cuijpers P A randomized controlled trial on the role of support in Internet-based problem solving therapy for depression and anxiety Behaviour Research and Therapy 2015 09 72 63 71 10.1016/j.brat.2015.06.013 26188373 S0005-7967(15)30005-X 26188373
+160 Newby JM Mackenzie A Williams AD McIntyre K Watts S Wong N Andrews G Internet cognitive behavioural therapy for mixed anxiety and depression: a randomized controlled trial and evidence of effectiveness in primary care Psychol Med 2013 12 43 12 2635 48 10.1017/S0033291713000111 23419552 S0033291713000111 23419552
+161 Proudfoot J Clarke J Birch M Whitton AE Parker G Manicavasagar V Harrison V Christensen H Hadzi-Pavlovic D Impact of a mobile phone and web program on symptom and functional outcomes for people with mild-to-moderate depression, anxiety and stress: a randomised controlled trial BMC Psychiatry 2013 11 18 13 312 10.1186/1471-244X-13-312 24237617 1471-244X-13-312 24237617 PMC4225666
+162 Titov N Dear BF Johnston L Lorian C Zou J Wootton B Spence J McEvoy PM Rapee RM Improving adherence and clinical outcomes in self-guided internet treatment for anxiety and depression: randomised controlled trial PLoS One 2013 8 7 e62873 10.1371/journal.pone.0062873 23843932 PONE-D-12-28419 23843932 PMC3701078
+163 Titov N Dear BF Schwencke G Andrews G Johnston L Craske MG McEvoy P Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial Behav Res Ther 2011 08 49 8 441 52 10.1016/j.brat.2011.03.007 21679925 S0005-7967(11)00079-9 21679925
+164 Adam A Jain A Pletnikova A Bagga R Vita A N Richey L Gould N Munshaw S Misrilall K Peters ME Use of a mobile app to augment psychotherapy in a community psychiatric clinic: feasibility and fidelity trial JMIR Form Res 2020 07 03 4 7 e17722 10.2196/17722 32618572 v4i7e17722 32618572 PMC7367543
+165 Johnston L Dear BF Gandy M Fogliati VJ Kayrouz R Sheehan J Rapee RM Titov N Exploring the efficacy and acceptability of internet-delivered cognitive behavioural therapy for young adults with anxiety and depression: an open trial Aust N Z J Psychiatry 2014 09 48 9 819 27 10.1177/0004867414527524 24622977 0004867414527524 24622977
+166 Kladnitski N Smith J Allen A Andrews G Newby JM Online mindfulness-enhanced cognitive behavioural therapy for anxiety and depression: outcomes of a pilot trial Internet Interv 2018 09 13 41 50 10.1016/j.invent.2018.06.003 30206518 S2214-7829(18)30007-1 30206518 PMC6112099
+167 Staples LG Fogliati VJ Dear BF Nielssen O Titov N Internet-delivered treatment for older adults with anxiety and depression: implementation of the Wellbeing Plus Course in routine clinical care and comparison with research trial outcomes BJPsych Open 2016 09 2 5 307 313 10.1192/bjpo.bp.116.003400 27703794 S2056472400001769 27703794 PMC5022107
+168 Wright JH Wright AS Salmon P Beck AT Kuykendall J Goldsmith LJ Zickel MB Development and initial testing of a multimedia program for computer-assisted cognitive therapy Am J Psychother 2002 56 1 76 86 10.1176/appi.psychotherapy.2002.56.1.76 11977785 11977785
+169 Eysenbach G The law of attrition J Med Internet Res 2005 03 31 7 1 e11 10.2196/jmir.7.1.e11 15829473 v7e11 15829473 PMC1550631
+170 Forbes A Keleher MR Venditto M DiBiasi F Assessing patient adherence to and engagement with digital interventions for depression in clinical trials: systematic literature review J Med Internet Res 2023 08 11 25 e43727 10.2196/43727 37566447 v25i1e43727 37566447 PMC10457707
+171 Lee P Abernethy A Shaywitz D Gundlapalli AV Weinstein J Doraiswamy PM Schulman K Madhavan S Digital health COVID-19 impact assessment: lessons learned and compelling needs NAM Perspect 2022 2022 10.31478/202201c 35402858 202201c PMC8970223 35402858
+172 Adu-Brimpong J Pugh J Darko DA Shieh L Examining diversity in digital therapeutics clinical trials: descriptive analysis J Med Internet Res 2023 08 02 25 e37447 10.2196/37447 37531157 v25i1e37447 37531157 PMC10433021
diff --git a/corpus/healthcare/text/f090119441704b4c.txt b/corpus/healthcare/text/f090119441704b4c.txt
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Front Public Health
+Journal ID: Front Public Health
+NLM Journal ID: 101616579
+Journal ID: Front. Public Health
+
+Frontiers in Public Health
+
+EISSN: 2296-2565
+Publisher: Frontiers Media SA
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13099913
+PMID: 42027923
+DOI: 10.3389/fpubh.2026.1791605
+Article version: 1
+Article version:
+Subjects: Brief Research Report
+
+Myasthenia gravis in Latin America and the Caribbean: epidemiology, resources, and accessibility to diagnosis and treatment
+
+Salutto Valeria L. 1 * Validation Writing – review & editing Investigation Supervision Formal analysis Visualization Software Data curation Project administration Writing – original draft Conceptualization Resources Methodology
+Navarro Cristian E. 2 Supervision Methodology Writing – review & editing Data curation Conceptualization Investigation Validation Formal analysis Writing – original draft Software Resources
+Urra Pincheira Alejandra 3 Investigation Data curation Formal analysis Conceptualization Writing – review & editing Writing – original draft Methodology
+Dondis Camaño David R. 4 Writing – review & editing Data curation
+Guerrero Karina 5 Data curation Writing – review & editing
+dos Santos André C. J. 6 Writing – review & editing Data curation
+Moreno Martinez Carlos A. 7 Data curation Writing – review & editing
+Ojeda Jacquet Víctor D. 8 Data curation Writing – review & editing
+Peñaloza Miranda Lenin 9 Data curation Writing – review & editing
+Perna Ramos Abayubá 10 Data curation Writing – review & editing
+Romero Suárez Guillermo 11 Data curation Writing – review & editing
+Vargas Cañas Edwin S. 12 Writing – review & editing Data curation
+Idiaquez Rios Juan Francisco 13 Data curation Writing – review & editing
+Barnett-Tapia Carolina 13 Supervision Writing – review & editing Investigation Conceptualization Validation Visualization
+1 Medical Research Institute Alfredo Lanari, Buenos Aires University , Buenos Aires , Argentina
+2 School of Medicine and School of Economic Sciences, Universidad de Antioquia , Medellín , Colombia
+3 Neuromuscular Unit, Department of Neurology and Psychiatry, Clínica Alemana , Santiago , Chile
+4 Centro de Neurociencias, Ciudad de la Salud, Caja de Seguro Social , Ciudad de Panamá , Panama
+5 Universidad Central de Venezuela , Caracas , Venezuela
+6 Ribeirão Preto School of Medicine, University of São Paulo , São Paulo , Brazil
+7 Hospital del Valle , San Pedro Sula , Honduras
+8 Hospital Central IPS , Asunción , Paraguay
+9 Caja Nacional de Salud , La Paz , Bolivia
+10 Centro Privado Montevideo , Montevideo , Uruguay
+11 Hospital Metropolitano de Quito , Quito , Ecuador
+12 National Institute of Neurology and Neurosurgery, Neuromuscular Diseases Clinic , Mexico City , Mexico
+13 Division of Neurology, Department of Medicine, University of Toronto , Toronto , ON , Canada
+* Correspondence: Valeria L. Salutto, vsalutto@gmail.com
+Electronic publication date: 2026 Apr 8
+Publication date: 2026
+Volume: 14
+Electronic Location ID: 1791605
+Received 2026 Jan 19; Revised 2026 Mar 15; Accepted 2026 Mar 23
+Copyright: Copyright © 2026 Salutto, Navarro, Urra Pincheira, Dondis Camaño, Guerrero, dos Santos, Moreno Martinez, Ojeda Jacquet, Peñaloza Miranda, Perna Ramos, Romero Suárez, Vargas Cañas, Idiaquez Rios and Barnett-Tapia.
+Copyright year: 2026
+Copyright holder: Salutto, Navarro, Urra Pincheira, Dondis Camaño, Guerrero, dos Santos, Moreno Martinez, Ojeda Jacquet, Peñaloza Miranda, Perna Ramos, Romero Suárez, Vargas Cañas, Idiaquez Rios and Barnett-Tapia
+License: This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: accessibility, health care costs, health economics, Latin America, myasthenia gravis
+
+Funding: The author(s) declared that financial support was not received for this work and/or its publication.
+
+Figure count: 1
+Table count: 4
+Equation count: 0
+Reference count: 58
+Page count: 10
+
+section-at-acceptance: Health Economics
+
+Ÿ==============================Ÿ
+Latin-American and Caribbean (LAC) countries face persistent challenges in achieving universal health coverage, with out-of-pocket healthcare expenditures posing a significant barrier. Access to care for rare diseases, such as myasthenia gravis (MG), is significantly impacted. We conducted an exploratory descriptive study between LAC countries, and we assessed the availability of diagnostic and therapeutic resources for MG across 12 LAC countries, along with associated costs and access barriers. We found marked inequalities regarding the availability and coverage of diagnostic tests and therapies by public healthcare systems. The elevated out-of-pocket costs, up to several times the minimum wage, and shortage of neurologists, makes appropriate diagnosis and treatments inaccessible for many patients living with MG. Novel treatments for MG are unavailable for most people with MG in Latin America.
+
+1 Introduction
+
+Latin America and The Caribbean (LAC) encompass 33 low- and middle-income countries with an inequality gap and a rapidly aging population. An increasingly growing middle class that is better informed adds pressure to the fragmented health systems that strive to provide universal coverage (1). With a combined population exceeding 690 million, 80% residing in urban areas and 21% in informal settlements or inadequate houses, LAC faces unique challenges in delivering equitable healthcare (1). High levels of informality and disparities in access to basic services exacerbate these challenges, often surpassing those observed in other parts of the world (1, 2). There is marked segmentation and variability in healthcare systems across the region (3). This contributes to heterogeneous levels of health coverage in LAC countries, ranging from approximately 76% in high-coverage nations such as Argentina, Brazil, Colombia, Mexico, and Uruguay, to significantly lower rates in countries like Bolivia (4, 5).
+
+Health systems include the public model, with public finance and provision; social security, including a national social security system; and the private one, consisting of voluntary insurance (6). These models coexist with variable hegemony. Sanitary indicators are dissimilar among the different countries, and some are outdated (5, 7, 8). The economy is developing, and the systems cannot guarantee proper and quality availability of technologies and medications (9). Main access barriers are out-of-pocket expenses on health, well above the average of countries from the Organization for Economic Cooperation and Development (OECD) (10, 11). In this context, rare diseases such as myasthenia gravis (MG) are often deprioritized in national health agendas, which tend to focus on nutritional deficiencies, infectious diseases and chronic cardiovascular conditions (1).
+
+MG is a chronic autoimmune neuromuscular disorder with a global mean prevalence of 173.3 (95% confidence interval [95%CI] 129.7–215.5) cases per million and a mean incidence of 15.7 (95%CI 11.5–19.9) cases per million person-years (12). In patients with rare diseases, the journey from the onset of symptoms to diagnosis (i.e., diagnostic odyssey) can take several years (average 4–5 years or longer) (13). Specifically, the diagnosis of MG can be challenging because fatigue, muscle weakness, and other symptoms are common to many diseases (14). The ASPIRE project identified barriers to timely diagnosis of patients with generalized MG, such as physicians confusing MG symptoms with women’s health problems, difficulty in accessing specialist care, and lack of knowledge of MG among health professionals (15).
+
+The economic burden of MG is substantial, estimated at $5,567 USD monthly per patient in the US, rising to $17,220 USD in case of crisis (16). Annual out-of-pocket costs (average, $15,798 USD) are primarily caused by medications, the cost of diagnosis, and health insurance premiums (17). Although scientific advances and novel therapies have transformed MG management in high-income countries, access to diagnostic tools and treatments in LAC remains scarce and uneven. Epidemiologic studies of MG in the region are limited and heterogeneous, reflecting different methodologies, environments, and unequal access to specialized care (18). There are no data from LAC countries regarding the economic burden of MG, nor for the available resources for diagnosis and treatments. We aimed to identify current access barriers and deficiencies in MG care across LAC, including availability of neurologists, diagnostic tests, and treatments, and their associated costs.
+
+2 Methods
+
+An exploratory descriptive study was conducted, combining a literature review and institutional database analysis (indirect sources) with a structured survey of neurologists managing MG patients across 12 LAC countries (direct source).
+
+2.1 Indirect data sources
+
+A comprehensive literature review was performed covering the period from 2010 to 2023. Databases included MEDLINE (via Pubmed), LILACS, and grey literature as policy revision, articles, Health Ministry webpages, and regional organization web pages. Publications in English, Spanish, and Portuguese were considered. The following MeSH and DeCS terms were used: Myasthenia Gravis; Epidemiology; Latin America; Health Status Indicators; Universal Health Coverage; Healthcare Financing; Public Health Services Coverage; Private Health Services Coverage; Diagnostic Tests; Drug Therapy; Out-of-Pocket Health Expenditures; Gross Domestic Product; Monthly Salary and Neurologist availability. Health indicators such as life expectancy at birth in LAC and other OECD countries were extracted (10).
+
+Indirect data were synthesized and categorized into three domains:
+
+Healthcare indicators: Life expectance at birth and Mortality rate (19).
+
+Economic indicators: Minimum monthly salary, Gross Domestic Product (GDP) for 2022 and the percentage of GDP allocated to health in the same year.
+
+Epidemiological data: Neurologist density per country and MG prevalence across LAC countries.
+
+2.2 Direct data sources
+
+A structured questionnaire was administered to 12 neurologists from 12 LAC countries (Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Honduras, Mexico, Panama, Paraguay, Uruguay, and Venezuela). These neurologists were identified during the 2023 Latin-American Neuromuscular Society (SOLANE) meeting, conducted in Bogotá, Colombia. Eligibility criteria included prior clinical experience in the management of MG. Survey responses were categorized into three modules:
+
+Diagnostic tests: Availability and cost of repetitive nerve stimulation (RNS), single-fiber electromyography (SFEMG), thoracic computed tomography (CT), and antibody testing.
+
+MG Treatments: Availability and cost of conventional therapies (pyridostigmine, corticosteroids, non-steroidal immunosuppressants, intravenous immunoglobulin and plasma exchange) and novel MG treatments (e.g., biologics).
+
+Healthcare coverage: Classification of the systems providing MG diagnostic tests and MG treatments, public and private healthcare systems of each country or international referral, and the degree of financial coverage. Private system was defined to include prepaid medical care, insurance policies, and private office care.
+
+Data collection occurred between August and December 2023 via structured forms completed by participating neurologists. A follow-up questionnaire was distributed in January 2024 to clarify and/or expand specific variables. Responses were grouped by country and healthcare coverage type. Diagnostic procedures and pharmacological treatments costs were retrieved from responses provided by neurologists and databases of national regulatory agencies in each surveyed country. Appendix A shows the questionnaire.
+
+2.3 Statistical analysis
+
+Descriptive statistics (absolute and relative frequencies, median, interquartile range [IQR], mean, standard deviation [SD]) were calculated for categorical and quantitative variables as appropriate. No inferential statistical tests were applied due to the exploratory nature of the study and the limited sample size.
+
+All cost-related data were converted from the national currency of each country into US dollars with an exchange rate for the year 2023 (20). To assess affordability the ratio between the monthly cost of common MG drugs (pyridostigmine, prednisone and azathioprine) if paid out-of-pocket, in relation to the minimum wage was calculated. The ratio was performed considering daily doses as follows: pyridostigmine 60 mg × 3 tablets, prednisone 15 mg and azathioprine 100 mg. Data analysis was conducted used Microsoft Excel-Office 365 (Microsoft Corporation, Redmond, WA, USA), and R software version 4.3.2 (The R Foundation for Statistical Computing, Vienna, Austria).
+
+This study was based on a review of the literature as well as a review of local and available databases. No individual data were collected and therefore this study did not require ethics approval nor informed consent.
+
+3 Results
+
+3.1 Indirect data sources
+
+Mean life expectance at birth for people in the 12 LAC countries was 76 years (21), compared to 81 years for OECD countries (10). There was marked regional gap; for example, life expectancy at birth in Bolivia was 68.5 years, while in Chile it was 81.2 years (21). Mortality ranged from 181.9 per 100,000 population in Chile to 492 per 100,000 population in Bolivia (22). The average rate of all causes of death in the LAC region was about 50% greater than the average for countries from the OECD (10).
+
+Related to economic variables, there was wide variability in the monthly minimum salary for the 12 included countries, ranging between $15 and $1,320 (mean $399 ± 323), as well as in the average GDP that ranged between $5,553,100,597 and $924,000,000,000 (mean $ 405,617,609,787 ± 618,879,000,785) (23). The average percentage of GDP allocated to health was 8.04% (SD 0.016; range 4.55–10.1%) (see Table 1) (23).
+
+Table 1 Economic and epidemiological characteristics in Latin American countries included in this study.
+
+Country	Minimum monthly salary	Gross Domestic Product (GDP) 2022	Percentage of the GDP allocated to health 2022 (%)	Number of neurologists (per 100,000 inhabitants)	Myasthenia gravis prevalence (per 100,000 inhabitants)	Reference	
+Argentina	$132	$5,553,100,597	9.86	2.9	36.71	(29, 34)	
+Bolivia	$300	$44,401,000,000	8.43	0.19	No data	(24)	
+Brazil	$1,320	$1,924,000,000,000	9.14	2.46	No data	(30)	
+Chile	$527	$308,812,607,775	10.1	3.27	8.36	(28, 35)	
+Colombia	$273	$360,179,535,840	7.69	1.15	14.3	(33, 36)	
+Ecuador	$250	$118,141,073,235	7.53	0.54	No data	(57)	
+Honduras	$417	$31,718,000,000	8.28	0.29	No data	(25)	
+México	$365	$1,414,101,000,000	5.72	1.53	No data	(32)	
+Panama	$315	$77,814,000,000	8.47	0.82	No data	(26)	
+Paraguay	$370	$41,722,000,000	7.74	0.58	No data	(58)	
+Uruguay	$500	$59,000,000,000	8.95	3.8	6.3	(27, 37)	
+Venezuela	$15	$482,360,000,000	4.55	1.69	No data	(31)	
+Adapted from World Bank database.
+
+Cost is standardized to 2023 US dollar.
+
+The number of neurologists per 100,000 population was lowest in Bolivia (0.19) (24), followed by Honduras (0.29) (25), and Panama (0.82) (26). The country with the greatest availability of neurologists was Uruguay (3.8) (27), followed by Chile (3.27) (28), Argentina (2.9) (29), Brazil (2.46) (30), Venezuela (1.69) (31), México (1.53) (32), and Colombia (1.15) (33). Bolivia and Paraguay do not have official sources or epidemiological studies describing the rate of neurologists per 100,000 inhabitants; in these cases, a calculation was made between the number of neurologists extracted from an official source and the population of the last census (see Table 1).
+
+The prevalence rate MG in Argentina was 36.71 per 100,000 person-years (between 2006 and 2012) (34); the prevalence per 100,000 population was 8.36 in Chile (2018) (35), 14.3 in Colombia (2023) (36), and 6.3 in Uruguay (between 1960 and 1976) (37) (Table 1). We did not find published estimates for the other countries.
+
+3.2 Direct data sources
+
+Every country has electrophysiologic studies available. Bolivia and Paraguay do not have SFEMG but have RNS. Overall, RNS is available in 11 (92%) countries; this is only through private health services in Bolivia, Honduras and Paraguay, and in both the public and private sectors in the rest of the countries. In Venezuela, RNS is not available in the public system, and we could not ascertain whether it is available in the private sector. SFEMG is available in 9 (75%) countries: in Brazil, Chile, Colombia, and Uruguay, it is available in both public and private systems, while in Argentina, Ecuador, Honduras, Mexico, and Panama, it is only available through private coverage. In Venezuela, SFEMG is not available in the public system, and we could not ascertain whether it is available in the private sector. Chest tomography (CT) is available in every country, and in 11 (92%) it is available in both public and private health systems, while in Venezuela, it is only available in the public system.
+
+Acetylcholine receptor (AChR) antibody detection is done locally in 8 (67%) countries; this is available in the public and private systems in Argentina, Brazil, Colombia, Mexico and Uruguay; and only privately in Panama, Paraguay, and Venezuela. In Chile, Ecuador and Honduras, blood samples are sent to an international lab, processed by private healthcare system, and are paid by the patient. Muscle-specific tyrosine kinase (MuSK) antibody testing is done locally in 6 (50%) countries: in Colombia and Mexico, this test is available in both the public and private systems; in Argentina, Brazil, Paraguay and Venezuela it is only through the private system. In Chile, Ecuador, Honduras and Panama, blood samples are sent to a laboratory abroad and paid by the patient. In Uruguay, a private laboratory sends blood samples abroad for the anti-MuSK test; however, it is having a very high cost. In Bolivia, antibody tests are not available in the public system, and whether they are available through international laboratories via private healthcare is unknown. Table 2 summarizes the costs of different diagnostic tests, and Figure 1 shows coverage of common diagnostic test for MG per country.
+
+Table 2 Costs of test used in the diagnosis of myasthenia gravis in 12 Latin American countries (prices in US dollars 2023).
+
+Country	Anti-AChR	Anti-MuSK	Chest CT	Repetitive nerve stimulation	Single fiber electromyography	
+Public	Private	Public	Private	Public	Private	Public	Private	Public	Private	
+Argentina	$60	$100	Not available	$145	$65	$180	$16	$82	Not available	$170	
+Bolivia	No data	No data	Not available	No data	$217	$217	Not available	$22	Not available	Not available	
+Brazil	$19	$39	Not available	$145	$58	$97	$19	$97	$97	$194	
+Chile	Not available	$137*	Not available	$137*	$54	$54	$26	Variable	$57	$57	
+Colombia	$63	$63	$217	$217	$40	$80	$14	$28	$24	$48	
+Ecuador	Not available	$150*	Not available	$392*	$35	$60	$40	$60–140	Not available	$200	
+Honduras	Not available	$120*	Not available	$525*	$170	$170	Not available	$162	Not available	$303	
+Mexico	$15	$15–50	$180	$100–180	$100–380	$100–380	$50	$170–290	Not available	$780	
+Panama	Not available	$200	Not available	$120*	$50	$550	$50	$250	Not available	$250	
+Paraguay	Not available	$110	Not available	$110*	$50	$50	Not available	$65	No available	Not available	
+Uruguay	$250	$250	$1,500	$1500*	$100–200	$100–200	$125	$125	$190	$190	
+Venezuela	Not available	$25	Not available	$35	$5	No data	Not available	No data	Not available	No data	
+AChR, acetylcholine receptor; MuSK, muscle-specific kinase.
+
+*Sample sent abroad.
+
+Figure 1 Coverage of diagnostic test for myasthenia gravis in 12 Latin American and Caribbean countries. This figure details the availability and coverage of diagnostic tests across public and private healthcare sectors for each country. “Sample sent abroad” indicates that the blood sample for antibody detection cannot be processed domestically. An “X” indicates that the sample is not forwarded to an international reference laboratory. A “?” denotes that no information is available. AChR, acetylcholine receptor; MuSK, muscle-specific kinase; CT, Chest CT; RNS, Repetitive nerve stimulation; SFEMG, Single fiber electromyography.
+
+Map of Latin America with labeled country borders and boxes displaying data by country concerning public and private access to specific medical tests (AChRA, Anti-MuSK, CT, RNS, SFEMG) and whether samples are sent abroad, showing variation in availability and international sample processing.
+
+Pyridostigmine is available in all countries; however, it is available exclusively through the private system in 5 (42%) countries: Bolivia, Ecuador, Honduras, Paraguay, and Venezuela. Pyridostigmine is available in both private and public systems in Argentina, Brazil, Chile, Colombia, Mexico, Panama, and Uruguay. Argentina has a national program that provides pyridostigmine free of charge for Argentine resident citizens through a bill for the MG Commemoration Day (Ley 26903 del 13 de Noviembre del 2013 [bill 26903, November 13th, 2013]). Steroids are available in all countries, in 10 (83%) of them in the public system. Azathioprine is available in all the countries, 9 (75%) in the public system. In Argentina and Venezuela, access to steroids and azathioprine is only possible through the private system; in the remaining countries, they are available in the public and private sectors. Paraguay is the exception: both systems cover the cost of steroids, but the cost of azathioprine is only covered by the private system. Mycophenolate is available in all countries, in 8 (67%) through the public system. It is only available in the private system in Argentina, Honduras, Paraguay, and Venezuela. Access to tacrolimus is restricted through public health systems and is only offered in Brazil, Colombia and Mexico. No data are available for Bolivia and Paraguay. Tacrolimus is unavailable in Uruguay; the patient can access this medication through a judicial mechanism. In the remaining countries, it is only available in the private system.
+
+Intravenous immunoglobulin (IVIg) is available in all countries but cannot be used as maintenance therapy for MG through any of the public healthcare systems. In the event of a myasthenic crisis one can use IVIg at the expense of public health system resources in Argentina, Bolivia, Brazil, Colombia, Mexico, Panama, Paraguay and Uruguay (67%). Plasmapheresis for MG crisis is available in Bolivia, Honduras, and Paraguay only through the private system. Colombia has plasmapheresis only in the public system. Rituximab is available (off-label) for MG through the public healthcare in Chile, Colombia, Mexico, Panama, Paraguay and Uruguay.
+
+Novel treatments are overall inaccessible. Only in the private system an individual with refractory MG can access eculizumab treatment in Argentina, this through legal recourse. Ravulizumab is approved in Argentina, Brazil, Chile, Ecuador, Mexico and Panama, but not covered; patients can have access to ravulizumab if they file a legal recourse (according to the legislation of each country). In the rest of the countries, the drugs are not available. Table 3 depicts the coverage of common MG medications.
+
+Table 3 Coverage of myasthenia gravis treatments in 12 Latin American countries.
+
+Drug	Public system coverage only	Private system coverage only	Public and Private system coverage	
+Pyridostigmine	7 (58%)	5 (42%)	12 (100%)	
+Prednisone	10 (83%)	2 (17%)	12 (100%)	
+Azathioprine	9 (75%)	3 (25%)	12 (100%)	
+Mycophenolate	8 (67%)	4 (33%)	12 (100%)	
+Tacrolimus	3 (25%)	7 (58%)	10 (83%)	
+Rituximab	6 (50%)	6 (50%)	12 (100%)	
+Cyclophosphamide	7 (58%)	2 (17%)	9 (75%)	
+IVIG (crisis)	8 (67%)	4 (33%)	12 (100%)	
+Plasma Exchange	9 (75%)	2 (17%)	11 (92%)	
+Complement C5 inhibitor	0 (0%)	0 (0%)	0 (0%)	
+
+Table 4 presents the costs of common MG medications. The monthly cost of MG treatments, if paying out-of-pocket, as a percentage of the minimum wage is variable. Considering a standard daily treatment of prednisone 15 mg, azathioprine 100 mg, and pyridostigmine 180 mg (60 mg three times a day), an individual would pay as low as 6% of the minimum wage in Brazil, 15% in Chile, 170% in Bolivia and up to 423,000% in Venezuela. Overall, in 6 (50%) of the countries a month of MG treatment has out-of-pocket costs >50% of the minimum wage (Supplementary Table 1).
+
+Table 4 Cost of myasthenia gravis treatments in 12 Latin American countries.
+
+Country	Pyridostigmine 60 mg tablet	Pyridostigmine monthly	Prednisone 5 mg tablet	Prednisone monthly	Azathioprine 50 mg tablet	Azathioprine monthly	
+Argentina	$0.50	$45	$0.24	$21.60	$0.50	$30.00	
+Bolivia	$1.00	$90	$2.00	$180.00	$4.00	$240.00	
+Brazil	$0.16	$14.40	$0.38	$34.20	$0.40	$24.00	
+Chile	$ 0.74	$66.6	$0.03	$2.70	$0.17	$10.20	
+Colombia	$2.21	$198.9	$0.61	$54.90	$0.54	$32.40	
+Ecuador	$0.50	$45	$0.12	$10.80	$0.78	$46.80	
+Honduras	$2.00	$180	$0.12	$10.80	$1.50	$90.00	
+México	$0.90	$81	$0.14	$12.60	$3.00	$180.00	
+Panama	$0.60	$54	$0.30	$27.00	$0.60	$36.00	
+Paraguay	$0.55	$49.5	$0.20	$18.00	$0.80	$48.00	
+Uruguay	$1.88	$169.2	$0.04	$3.60	$0.32	$19.20	
+Venezuela	$0.65	$58.5	$30.00	$2,700.00	$60.00	$3,600.00	
+Cost is standardized to 2023 US dollar.
+
+Monthly cost considering the following doses: Pyridostigmine 60 mg three times per day, Prednisone 15 mg per day and Azathioprine 100 mg per day. Calculation of the monthly cost according to the price of each medication in each country.
+
+4 Discussion
+
+This study provides an overview of the availability of diagnostic and therapeutic resources for MG in LAC countries. The results highlight substantial disparities among countries in access to health technologies, ranging from those considered essential for the care of MG patients to more advanced interventions, particularly regarding treatments such as monoclonal antibodies. This reflects the described differences in health system structures and the variability in the availability of trained personnel for the management of these patients. Our analysis identified marked heterogeneity in health indicators, such as life expectancy and mortality rate, emphasizing the profound inequities in the region’s health systems (10). Importantly, our data suggest that a higher GDP (global or per capita), does not necessarily translate into better access to health technologies within public health systems or private insurance coverage.
+
+Chile is the country that assigns the most resources as GDP percentage (10.1%), followed by Argentina (9.86%) and Brazil (9.14%). Venezuela has the lowest resource allocation, with 4.55% of the GDP. It is worth noting that in low- and middle-income countries, optimal financial mechanisms to achieve Universal Health Coverage remain an ongoing subject of debate, and there is no universally accepted guideline for tax-based health financing beyond the general recommendation of allocating approximately 5% of GDP to healthcare (38).
+
+Access to neurologists is the first barrier to a prompt diagnosis of MG, and while this was variable within LAC countries, all were below the mean of 7.1 neurologists per 100,000 inhabitants reported for high income countries, and below the WHO recommendation (5 neurologists per 100,000 inhabitants) (39, 40). In our survey, Uruguay had the highest density of neurologists (3.8/100,000 inhabitants), whereas Bolivia had only 0.19 per 100,000 inhabitants. A lack of neurology specialists in Latin America, may be largely due to very limited institutional opportunities of training throughout the region, for example, only 0.67% of the residency vacancies in Argentina in 2023 were assigned to neurology (41). For many LAC professionals seeking training in neurology, the only option is to go abroad. Furthermore, accessing a specialized program in neuroimmunology or neuromuscular medicine is even more challenging (40). There are no data regarding the number of neurologists with neuromuscular training in LAC countries, but very few countries have subspecialty programs and therefore this number is likely very low, and concentrated in large cities, increasing disparities for patients in smaller cities and rural areas (29, 42).
+
+Delays in accessing neurological consultations for diagnosis may be attributed to a shortage of specialists, geographic barriers requiring long-distance travel for patients in nonurban LAC settings, and a lack of urgent referrals from primary care physicians. Preliminary data from a multicenter retrospective study in Argentina reported a mean diagnostic delay—defined as the interval between symptom onset and MG diagnosis—of 422.6 days (SD 771.5 days), with significantly shorter delays among patients initially evaluated by neurologists compared with those first seen by other specialists (mean 116.5 days vs. 459.1 days; p = 0.015) (43). Comparatively a multicenter European study including five countries reported a mean diagnostic delay of 363.1 days (SD 520.9 days) (44). Diagnostic errors may also contribute to delayed recognition of MG; misdiagnosis as a psychiatric disorder has been associated with presentation as a myasthenic crisis before the correct diagnosis is established (45).
+
+These findings are consistent with data from the ASPIRE project, which described the complexity of the diagnostic journey for patients with generalized MG. The study showed that racial and ethnic minority groups, as well as female patients, experienced longer and more burdensome diagnostic pathways (15). A delay in MG diagnosis would be associated with a delay in initiating appropriate treatment and a higher risk of myasthenic exacerbations/crises and comorbidities. Evidence suggests that patients with longer diagnostic delay may experience higher disease burden, comorbid anxiety and depression, greater involvement of healthcare professionals, and lower health-related quality of life than those with early diagnosis (44).
+
+The variability in MG prevalence across the LAC region may be attributed to methodological discrepancies or diagnostic inaccuracies—including misdiagnosis, underdiagnosis, and overdiagnosis—which likely reflect unequal access to specialized neurological care. For instance, the prevalence reported in Argentina (36.71 per 100,000) significantly exceeds the global mean of 17.33 per 100,000 estimated in a recent systematic review (12). Furthermore, it is four times higher than the prevalence reported in Chile (8.36 per 100,000). This striking disparity can largely be explained by differences in study design: the Argentine estimate derives from a retrospective study at a single private referral hospital in Buenos Aires (34), whereas the Chilean study utilized a capture–recapture methodology, cross-referencing a national pyridostigmine registry with a patient survey (35). Another crucial factor is the global rise in very late-onset MG (patients over 65 years of age), a demographic that frequently remains underdiagnosed (18, 46, 47). Additionally, regional heterogeneity may be driven by variations in environmental risk factors, ethnic diversity, and socioeconomic status. To the best of our knowledge, no Latin American genetic studies are currently available linking familial inheritance to disease prevalence, prognosis, and response to treatment. Finally, recent infectious outbreaks have introduced new epidemiological variables (48). While an Italian study may not establish a direct association between incident MG cases and COVID-19 infection or vaccination, data from Brazil indicated that the rise in MG-related mortality (from 0.76% in 2011 to 1.90% in 2023) was closely linked to COVID-19 infections among unvaccinated individuals (30).
+
+Although a high proportion of the countries surveyed have the technologies required to diagnose MG, significant disparities exist, particularly regarding their low availability within public healthcare systems. For example, SFEMG, the most sensitive test (49), is only available in the public system in 33% of the 12 ascertained countries. While the prices we obtained do not reflect out-of-pocket costs, as some patients have insurance, many individuals without coverage would not be able to afford this. For example, the cost of SFEMG in Mexico can reach up to $780, almost two times the minimum wage. Similarly, AChR antibody testing is only available through the public system in 42% countries, and therefore, limited for those individuals of low income and/or without private insurance. Of note, we only ascertained the availability of commercial AChR antibody, and cell-based assays were not available at time of data collection. Anti-MuSK testing is even more limited, only publicly funded in 17% of countries and available through private systems with a high cost, up to $1,500 in Uruguay, three times the minimum wage. The need to send samples abroad for AChR and MuSK antibody analysis represents a critical barrier, exacerbating diagnostic delays and significantly increasing the cost of the process. All countries have CT scanners in the public system, but the numbers are below the OECD average, which is ~30 per 1,000,000 population; in our study even the countries with highest number of scanners (Brazil and Chile) were below the OECD mean (50). Significant disparities in diagnostic delay are also expected between patients in the public healthcare system versus those in the private sector (51).
+
+Regarding treatments for MG, prednisone is available in all countries, and publicly funded in 83%, followed by 75% public coverage for azathioprine, and 67% public coverage for mycophenolate. Pyridostigmine—the only drug in the WHO list of essential medications for MG—is only covered publicly in 58% of the countries ascertained, with a high cost in some up to $2.21 for each tablet, for example in Colombia. While it is not a disease-modifying treatment, it is considered as the first line of treatment by guidelines from high income countries (52, 53). At the time of our data collection, of the novel treatments for MG, only eculizumab and ravulizumab had been approved in some LAC countries, but are available almost exclusively in the private sector, through complex administrative and legal procedures. Effectively, novel treatments are inaccessible for most people living with MG in LAC. The emergence of new high-cost therapies for MG increases will exacerbate health financing issues in LAC countries and will increase judicial procedures to ensure rights protection and healthcare access (17). Given that some countries have limited public funding for standard of care treatments for MG, such as pyridostigmine, it is unlikely that novel and expensive treatments will be accessible for most patients.
+
+In LAC, the health system is segmented since most countries have subsystems with doubled functions of governance, financing, and service provision; this is the key to resource misuse (38). Public resources deficit gives rice to private intervention in individual insurance and service delivery (6). For individuals without coverage through the public healthcare system, out-of-pocket costs can be exceedingly high and limit access to diagnosis and standard of care treatments. Out-of-pocket health costs are one of the main obstacles to accessing care (10, 17, 54).
+
+In 2019, health expenditure represented, on average, 6.9% of the GDP in LAC compared to 8.5% in OECD countries. In LAC countries, 60% of health expenditure comes from governmental and mandatory insurance plans, while out-of-pocket payments, voluntary payments, and external resources plans cover the remaining 40%. Conversely, in OECD countries, governmental and mandatory insurance represent 77% of the health expenditure. In LAC in 2019, on average, 32.4% of health expenditure was paid out of pocket, above the 20% average in OECD (55). The high level of out-of-pocket expenses in LAC is evidence of weak health systems and low coverage levels (1). In 2015, Argentina spent 10.2% of its GDP on health care but only 3% on public health, with a per-capita health expenditure of $1,390; however, Mexico and Brazil had similar public health expenditures (2.2–3.0% and 3.3–4.5%, respectively). In Argentina, 5% of the population expends more than 25% of the household expenditure on healthcare, while in Brazil it is 13% (4). The high dependency on out-of-pocket expenses produces a significant inequality in access to diagnosis and treatment, especially for rare diseases such as MG. In the past years there has been exponential increase in novel and more targeted treatments for MG; however, these are currently only accessible in high income countries and will likely remain inaccessible for most patients worldwide. Consequently, cost plays a critical role in decisions regarding treatment initiation (56).
+
+4.1 Limitations
+
+This study has several limitations. First, to ensure broad geographic representation, data collection relied on a single key informant per country. Although these participants were highly experienced neuromuscular specialists with deep knowledge of local diagnostic pathways and healthcare barriers, relying on a single expert may not fully capture the intra-national variability of each healthcare system. Nevertheless, this approach facilitated standardized data collection and cross-country comparisons. A second limitation is the scarcity of standardized data regarding available health technologies and costs in several countries. The high number of private providers across the region drives significant cost variability, limiting our analysis to the best available estimates rather than exact figures. However, our primary objective was to highlight regional disparities in healthcare access rather than to conduct a formal economic evaluation, which would require a different methodological design. Despite its exploratory nature, this study successfully identifies critical gaps and inequalities in the management of MG across LAC. These findings should be interpreted with caution and serve as a foundational step for future multicenter studies involving a greater number of specialists to validate and expand upon these regional nuances.
+
+5 Conclusion
+
+The study shows significant disparities between countries in terms of health indicators and healthcare financing. This variability is also observed in the management of MG, as evidenced by the scarcity of epidemiological studies, low number of neurologists, the lack of specialized tests for MG diagnosis, and even their complete absence in some countries. Most diagnostic tests are characterized by limited availability, inadequate public coverage, and significant cost variability. Regarding treatment, while conventional therapy is widely available, disparities exist in terms of cost and coverage. Access to biologic medications is generally obtained through legal procedures.
+
+Despite the availability of diagnostic tests and standard treatments for MG in LAC, inequalities and inconsistencies persist within health systems. The elevated out-of-pocket costs, up to several times the minimum wage, and shortage of resources, makes appropriate diagnosis and treatments inaccessible for many patients living with MG. Novel treatments for MG are unavailable for most people with MG in Latin America. The solution lies not only in increased public spending, but also in structural reform that integrates governance and financing functions, as well as strategic price regulation to reduce the healthcare gap. Implementing a referral program between primary and specialized care could be an option to unlock the management of patients with fewer resources and rare diseases. The global neurology community must come together to help improve care of MG in LAC and other lower income countries. This includes helping train neurologists and neuromuscular specialists who can provide care for patients with MG, building affordable networks for antibody testing, as well as networking with MG specialists around the world to help with challenging cases, when there is scarce local expertise.
+
+Data availability statement
+
+The original contributions presented in the study are included in the article/Supplementary material, further inquiries can be directed to the corresponding author.
+
+Author contributions
+
+VS: Validation, Writing – review & editing, Investigation, Supervision, Formal analysis, Visualization, Software, Data curation, Project administration, Writing – original draft, Conceptualization, Resources, Methodology. CN: Supervision, Methodology, Writing – review & editing, Data curation, Conceptualization, Investigation, Validation, Formal analysis, Writing – original draft, Software, Resources. AU: Investigation, Data curation, Formal analysis, Conceptualization, Writing – review & editing, Writing – original draft, Methodology. DD: Writing – review & editing, Data curation. KG: Data curation, Writing – review & editing. AS: Writing – review & editing, Data curation. CM: Data curation, Writing – review & editing. VO: Data curation, Writing – review & editing. LP: Data curation, Writing – review & editing. AP: Data curation, Writing – review & editing. GR: Data curation, Writing – review & editing. EV: Writing – review & editing, Data curation. JI: Data curation, Writing – review & editing. CB-T: Supervision, Writing – review & editing, Investigation, Conceptualization, Validation, Visualization.
+
+Conflict of interest
+
+VS has received funding from AstraZeneca for advisory board memberships, meetings, and symposiums in Latin America; from Takeda and Sanofi for advisory board memberships and travel; and from CSL, PTC, Merck and Sanofi for conference participation. AP has received an invitation to Clinical Autonomic Disorders: Case-Based and Laboratory Workshop 2025, and Expanded Clinical Autonomic Training, Mayo Clinic, by PTC. Invitation to 2025 Annual Meeting AANEM by Aztrazeneca. DD has received conference registration from Megalabs and Roche. VO has received financial support from Laboratorio Ferrer to develop a study. EV has received funding as a consultant and speaker from Johnson & Johnson, AstraZeneca, and UCB Pharma. CB-T has served as member of the advisory board for argenx, Alexion, UCB, Janssen and NMD Pharma. She has been a consultant for argenx, Alexion, Janssen, Novartis, NMD Pharma and UCB. She has received research support (paid to her institution) from US Department of Defense, Muscular Dystrophy Canada, MGNet, argenx, Cartesian and Alexion. CB-T is the primary developer of the MGII and may receive royalties.
+
+The remaining author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
+
+Generative AI statement
+
+The author(s) declared that Generative AI was not used in the creation of this manuscript.
+
+Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.
+
+Publisher’s note
+
+All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
+
+Supplementary material
+
+The Supplementary material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fpubh.2026.1791605/full#supplementary-material
+
+Edited by: Víctor Hugo Fernández-Bedoya, Universidad Nacional Mayor de San Marcos, Peru
+
+Reviewed by: Annibale Antonioni, University of Ferrara, Italy
+
+Rudy Mercelis, Antwerp University Hospital, Belgium
+
+
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diff --git a/corpus/healthcare/text/f10a3bb4e8d1430a.txt b/corpus/healthcare/text/f10a3bb4e8d1430a.txt
new file mode 100644
index 0000000000000000000000000000000000000000..b3fbfeb8bf6a94c87b4c965ca1bb9e76b09fcdcc
--- /dev/null
+++ b/corpus/healthcare/text/f10a3bb4e8d1430a.txt
@@ -0,0 +1,62 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Biomolecules
+Journal ID: Biomolecules
+NLM Journal ID: 101596414
+Journal ID: biomolecules
+
+Biomolecules
+
+EISSN: 2218-273X
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13406878
+PMID: 42509868
+DOI: 10.3390/biom16071041
+Article ID: biomolecules-16-01041
+Article version: 1
+Subjects: Correction
+
+Correction: Reis et al. Recombinant Human Peptide Growth Factors, Bone Morphogenetic Protein-7 (rhBMP7), and Platelet-Derived Growth Factor-BB (rhPDGF-BB) for Osteoporosis Treatment in an Oophorectomized Rat Model. Biomolecules 2024, 14, 317
+
+Reis Thamara Gonçalves 1 2
+Del Colletto Alice Marcela Sampaio 1 3
+Silva Luiz Augusto Santana 4
+Koga Bruna Andrade Aguiar 1 3
+https://orcid.org/0000-0003-4805-4609 Sogayar Mari Cleide 1 2 5 *
+https://orcid.org/0000-0002-9142-1155 Carreira Ana Claudia Oliveira 1 3 *
+1 Cell and Molecular Therapy Group (NUCEL), School of Medicine, University of São Paulo, São Paulo 01246-903, SP, Brazil; thamara.gr23@gmail.com (T.G.R.); alicesampaiodelcolletto@gmail.com (A.M.S.D.C.); brunaaguiar5@gmail.com (B.A.A.K.)
+2 Biotechnology Graduate Program (PPG-USP), University of São Paulo, São Paulo 05508-900, SP, Brazil
+3 Surgery Department, School of Veterinary Medicine and Animal Science, University of São Paulo, São Paulo 05508-270, SP, Brazil
+4 PathoDxVet, São Paulo 02925-000, SP, Brazil; lzs1.augusto@gmail.com
+5 Biochemistry Department, Chemistry Institute, University of São Paulo, São Paulo 05588-000, SP, Brazil
+* Correspondence: mcsoga@iq.usp.br (M.C.S.); ancoc@iq.usp.br (A.C.O.C.); Tel.: +55-11-99204-2844 (M.C.S.); +55-11-98322-9615 (A.C.O.C.)
+Electronic publication date: 2026 Jul 17
+Publication date: 2026 Jul
+Volume: 16
+Issue: 7
+Electronic Location ID: 1041
+Received 2026 Jun 15; Accepted 2026 Jun 16
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Erratum for: Recombinant Human Peptide Growth Factors, Bone Morphogenetic Protein-7 (rhBMP7), and Platelet-Derived Growth Factor-BB (rhPDGF-BB) for Osteoporosis Treatment in an Oophorectomized Rat Model 14 3 7 3 2024 317 Biomolecules 10.3390/biom14030317 PMC10968076 38540737
+
+Ÿ==============================Ÿ
+In the original publication [1], there was a mistake in Figures 6 and 7 as published. Due to an inadvertent error during the final assembly of the figures, the images for the PDGF-BB 2×/week group in these figures were incorrectly replaced by duplicates from another experimental group. The corrected Figure 6 and Figure 7 appear below. The authors state that the scientific conclusions are unaffected. This correction was approved by the Academic Editor. The original publication has also been updated.
+
+Figure 6 Masson’s trichrome stained histological slides comparing the different treatments. (A): Vehicle; (B): Zoledronic acid; (C): PDGF-BB 2×/week; (D): PDGF-BB 1×/week; (E): BMP-7 2×/week (F): BMP-7 1×/week; (G): PDGF-BB + BMP-7 2×/week (H): PDGF-BB + BMP-7 1×/week. Scale bar: 100 µm. In blue are collagen fibers, cytoplasm in red, and cell nuclei in purple. Ad: Adipocytes; BM: Bone marrow; Tr: Trabeculae; EL: Epiphyseal line.
+
+Figure 7 Histological slides stained with HE comparing the different groups analyzed. (A): Vehicle; (B): Zoledronic acid; (C): PDGF-BB 2×/week; (D): PDGF-BB 1×/week; (E): BMP-7 2×/week (F): BMP-7 1×/week; (G): PDGF-BB + BMP-7 2×/week (H): PDGF-BB + BMP-7 1×/week. Scale bar: 100 µm. In pink/reddish are the cytoplasm and collagen fibers, in purple were stained the cell nuclei. Ad: Adipocytes; BM: Bone marrow; Tr: Trabeculae; EL: Epiphyseal line.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+Reference
+
+1. Reis T.G. Del Colletto A.M.S. Silva L.A.S. Koga B.A.A. Sogayar M.C. Carreira A.C.O. Recombinant Human Peptide Growth Factors, Bone Morphogenetic Protein-7 (rhBMP7), and Platelet-Derived Growth Factor-BB (rhPDGF-BB) for Osteoporosis Treatment in an Oophorectomized Rat Model Biomolecules 2024 14 317 10.3390/biom14030317 38540737 PMC10968076
diff --git a/corpus/healthcare/text/f1d45d1da7505758.txt b/corpus/healthcare/text/f1d45d1da7505758.txt
new file mode 100644
index 0000000000000000000000000000000000000000..1a5333082c7f8983db7e574d0d66afb1c9826d3e
--- /dev/null
+++ b/corpus/healthcare/text/f1d45d1da7505758.txt
@@ -0,0 +1,686 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: BMC Geriatr
+Journal ID: BMC Geriatr
+NLM Journal ID: 100968548
+
+BMC Geriatrics
+
+EISSN: 1471-2318
+Publisher: BMC
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12903305
+PMID: 41545925
+DOI: 10.1186/s12877-026-06984-z
+Article ID: 6984
+Article version: 1
+Subjects: Systematic Review
+
+Association between sociodemographic factors and mobility among older adults: a systematic review and meta-analysis
+
+Onyeso Ogochukwu Kelechi ok.onyeso@uleth.ca kzetfrank@yahoo.com
+1 2
+Scott David R. 3
+Alumona Chiedozie James 1 2
+Kalu Michael E. 2 4
+Adandom Israel Ikechukwu 2 5
+Akinrolie Olayinka 2 6
+Onyeso Kelechi Mirabel 7
+Odole Adesola C. 8
+Victor Janice 1
+Doan Jon 1
+Awosoga Oluwagbohunmi A. 1
+1 https://ror.org/044j76961 grid.47609.3c 0000 0000 9471 0214 Faculty of Health Sciences, University of Lethbridge, Lethbridge, Alberta Canada
+2 Emerging Researchers and Professionals in Ageing-African Network, Abuja, Nigeria
+3 https://ror.org/044j76961 grid.47609.3c 0000 0000 9471 0214 University of Lethbridge Library, Lethbridge, Alberta Canada
+4 https://ror.org/05fq50484 grid.21100.32 0000 0004 1936 9430 School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, Ontario Canada
+5 https://ror.org/03xrrjk67 grid.411015.0 0000 0001 0727 7545 Department of Kinesiology, College of Education, The University of Alabama, Tuscaloosa, AL USA
+6 https://ror.org/03yjb2x39 grid.22072.35 0000 0004 1936 7697 Lifespan Brain Health Laboratory, Department of Psychology, University of Calgary, Calgary, Alberta Canada
+7 https://ror.org/01sn1yx84 grid.10757.34 0000 0001 2108 8257 Department of Estate Management, Faculty of Environmental Sciences, University of Nigeria, Nsukka, Enugu, Nigeria
+8 https://ror.org/03wx2rr30 grid.9582.6 0000 0004 1794 5983 Department of Physiotherapy, Faculty of Clinical Sciences, College of Medicine, University of Ibadan, Ibadan, Oyo Nigeria
+Electronic publication date: 2026 Jan 16
+Publication date: 2026
+Volume: 26
+Electronic Location ID: 208
+Received 2024 Jun 2; Accepted 2026 Jan 7
+Copyright: © The Author(s) 2026
+Copyright year: 2026
+License: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Ageing, Community-dwelling, Gait speed, Mobility decline, Social determinants of health, Social gerontology, Socioeconomic
+issue-copyright-statement: © BioMed Central Ltd., part of Springer Nature 2026
+
+Ÿ==============================Ÿ
+Background
+
+Mobility limitation is associated with poor quality of life, morbidity, and mortality among older adults. This pre-registered systematic review [PROSPERO CRD42022298570] synthesised the coefficients of association between sociodemographic factors and performance-based mobility outcomes in older adults (≥ 60 years).
+
+Methods
+
+Electronic databases MEDLINE, WoS, EMBASE, CINAHL, AgeLine, and SPORTDiscus were searched from inception to 27 November 2023 for observational studies reporting an association between sociodemographic factors and performance-based mobility outcomes among older adults. Pairs of reviewers independently conducted title, abstract, and full-text screening, narrative synthesis, and meta-analysis following the PRISMA and MOOSE guidelines. The effect sizes, heterogeneity, dominance, and publication bias were analysed using R/R-Studio (version 4.3.2) and CMA (version 4).
+
+Results
+
+Of the 9,328 studies screened, 57 were included (n = 130,060 participants); the pooled mean age was 69.81 ± 7.21years, habitual gait speed (HGS) = 1.01 ± 0.28 m/s, and time-up and go score = 7.67 ± 3.56s. The narrative synthesis showed that the majority of the studies found older age (92.2%), women (62.9%), non-Caucasian (75.0%), and lower education (64.5%) associated with significant mobility outcomes. There was a paucity of studies on marital status, area of residence, income, occupation, religion, homeownership, and social status. Meta-analysis showed that older age r=-0.37 [-0.42, -0.32] and female gender r=-0.13 [-0.22, -0.03] were moderately associated with slower HGS.
+
+Conclusion
+
+Older age, female gender, non-Caucasian identity, and lower education were consistently associated with poorer mobility outcomes, pointing to sociodemographic sources of inequity and the need for targeted interventions. Limited evidence on marital status, residence, income, occupation, religion, homeownership, and social status restricted broader conclusions. Expanding research across these domains is critical to inform comprehensive strategies that advance equitable mobility and healthier ageing in diverse populations.
+
+Trial registration
+
+Systematic review registration: PROSPERO CRD42022298570.
+
+Supplementary Information
+
+The online version contains supplementary material available at 10.1186/s12877-026-06984-z.
+
+Background
+
+Mobility is the ability of an individual to ambulate safely and independently, with or without a walking aid [1, 2]. Mobility is crucial for performing activities of daily living and impacts an individual’s independence and overall health [1, 3, 4]. Mobility limitation has dire consequences for older adults, including physical disability and institutionalisation [4], frequent falls and injuries [5], sedentary behaviour and dependency [3, 6], depression [7], social isolation [8], reduced quality of life [9], and death [4].
+
+This review focuses on older adults aged 60 years and older [10]. The study is timely, as the global population of older adults is projected to reach 2.1 billion by 2050, placing unprecedented strain on the health, economic, and social systems of countries [10]. Several population-based studies have shown that mobility limitations in later life vary by sociodemographic characteristics such as age, sex or gender, income, education, and marital status [11–13]. Cohort evidence from studies such as the Health and Retirement Study in the United States of America [11], Longitudinal Ageing Study Amsterdam in the Netherlands [14], Ibadan Study on Aging in Nigeria [15], and the China Health and Retirement Longitudinal Study [16] suggests that lower socioeconomic position, limited educational attainment, non-Caucasian ethnicity, and being a woman are consistently associated with slower gait speed and an earlier onset of mobility limitations. However, findings across studies remain inconsistent because of differences in population composition, measurement tools, and analytic approaches, leaving uncertainty about the overall direction and magnitude of these associations [17].
+
+There is a paucity of systematic literature reviews and meta-analyses on the broader sociodemographic determinants of mobility in older adults. Recent scoping reviews focused on cognitive, psychological, and environmental factors with little emphasis on social behaviour [18, 19]. Existing systematic reviews [20–22] mainly examined modifiable biophysical risk factors, treating sociodemographic variables as background descriptors rather than as core explanatory determinants. Therefore, a dedicated synthesis is needed to quantify these relationships and clarify social gradients in mobility, informing equity-focused ageing policy [17].
+
+This review is guided by the life-course [23] and social determinants of health (SDH) [24] frameworks, which together explain how cumulative exposures and structural contexts shape health in later life. The SDH framework highlights how health inequalities, including mobility trajectories, are shaped by economic policies, development agendas, social norms, social policies, and political systems [24, 25], while the life-course perspective emphasises that early-life socially constructed experiences accumulate over time and influence functional capacity in old age [26]. Integrating these theories allows interpretation of mobility disparities as products of both lifelong accumulation and current social inequities.
+
+Grounded on life-course and SDH theories, we conceptualised that mobility decline in older adults could be associated with cumulative sociodemographic influences, such as age, gender, marital status, area of residence, income, education, occupation, religion, social status, house ownership, and race or ethnicity [17]. Hence, we conducted a systematic review and meta-analysis of the association between sociodemographic factors and performance-based walking outcomes among community-dwelling older adults. The performance-based mobility outcomes included walk speed, time, and distance, measured through timed-up and go (TUG), habitual/usual gait speed (HGS), and time- and distance-specified walk tests [27]. Understanding the sociodemographic factors contributing to mobility decline among older adults is essential for formulating policies on ageing, allocating resources, and implementing geriatric interventions [28].
+
+The research questions were as follows: (1) What is the direction of the association between sociodemographic factors and performance-based walking outcomes among community-dwelling older adults as reported in literature published from 1947 to 2023? and (2) What is the pooled effect size of the association between sociodemographic factors and performance-based walking outcomes among community-dwelling older adults?
+
+Methods
+
+Protocol and registration
+
+The protocol [17] was registered within the International Prospective Register of Systematic Reviews (PROSPERO, CRD42022298570). The review was conducted and reported in adherence to the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-2020) [29] and the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines [30]. The PRISMA-2020 checklist is provided in Supplementary File 1.
+
+Due to the nature of the extracted data, we deviated from the published protocol as follows: (1) the pooled effect size was correlation coefficient (r) instead of odds ratio, (2) the risk of bias (ROB) assessment tool was changed from Prediction Model Risk of Bias Assessment Tool (PROBAST) to Joanna Briggs Institute’s (JBI) ROB appraisal checklist for analytic cross-sectional studies, (3) we conducted meta-analysis regardless of I2 statistics > 75%, (4) subgroup analysis of studies within 20-year intervals from 1947 to 2023 was not feasible because of limited number of included studies before 2009, (5) to facilitate the interpretation of the effect size (r), only zero-order and not partial correlation were included in the meta-analysis, and (6) the review timeline was amended and the search end date was extended from 28 February to 27 November 2023.
+
+Population, exposure, outcome, and timeline (PEOT) criteria
+
+The study population was community-dwelling older adults aged 60 years and older. The exposure was sociodemographic factors: age, gender, marital status, area of residence, income, education, occupation, religion, social status, house ownership, and race or ethnicity. The outcome was performance-based walking outcomes: walking distance (m), time (s), and speed (m/s) obtained through timed-up and go test (TUG – 3 m and 8 ft), short physical performance battery (SPPB – gait speed component), timed walk test e.g. six-minute walk test (6MinWT), distance walk test e.g. ten-metre walk test (10MWT), and habitual gait speed (HGS) [27]. The review timeline was from the inception of the oldest included database (EMBASE-1947) to 27 November 2023.
+
+Eligibility criteria
+
+Inclusion criteria
+
+Studies were included if they (1) described an association between any sociodemographic variable and walk distance, walk time, or walk speed, (2) included older adult participants aged 60 years and older, or with a mean age of ≥ 60 years, and (3) were observational studies published in the English language between 1947 and 27 November 2023.
+
+Exclusion criteria
+
+Studies were excluded if (1) the target population were non-ambulatory, hospitalised, institutionalised, or continuing care facility residents, (2) conducted among older adults with specific disease conditions, including cancer, stroke, parkinsonism, Alzheimer’s disease, dementia, arthritis, sarcopenia, diabetes, chronic obstructive pulmonary disease, and organ failures, such as kidney or heart failure, and (3) the data were overlapping or a duplicate of an already included study.
+
+Information sources
+
+Following Bramer and colleagues’ recommendation on electronic databases combination [31], MEDLINE (Ovid), EMBASE (Ovid), Web of Science, AgeLine (EBSCO), SPORTDiscus (EBSCO), and CINAHL (EBSCO) were searched from inception to 27 November 2023 by a health sciences librarian (DRS).
+
+Search strategy
+
+Search terms were identified through consultations between the primary investigator (OKO), content experts (OAA, ACO, OA, MEK, JV, and JD), and the librarian (DRS), and a review of the titles and abstracts of six seed articles gathered by the primary investigator [12, 32–36]. Elements of search strings developed for previously published reviews also informed the search strategy [37–39]. Following the publication of the review protocol, the search strategy was reviewed by another librarian using the Peer Review of Electronic Search Strategies (PRESS) checklist [40], and several minor revisions were made based on the feedback provided. The search strategy was first developed for MEDLINE (Fig. 1) and then adapted for the other five databases (Supplementary File 2). When possible, subject headings from controlled vocabularies (e.g., MeSH) were used in the search. The search sensitivity was enhanced by entering concepts in the search string as keywords with truncation (e.g., ethnic*) and proximity operators (e.g., adj5) used when appropriate. Boolean operators connected subject headings and keywords, as shown in Fig. 1.
+
+Fig. 1 MEDLINE search strategy for the systematic review
+
+Data management and study selection
+
+The retrieved articles’ bibliographic information, including title, abstract, authors, publication metadata, and subject headings, was imported into EndNote 20 for deduplication [31]. After removing duplicate records, the articles were exported to Covidence, a systematic review management software [41], and screened in two phases: title/abstract and full-text screening. Two independent reviewers from the authorship list, randomly assigned by Covidence, completed the screening, with the software automatically assigning a third independent reviewer (OKO, CJA, IIA, or KMO) to resolve conflicts. Similarly, a pair of independent reviewers (OKO, CJA, IIA, or MEK) simultaneously completed the data extraction and risk of bias (ROB) assessment within Covidence using customised templates [17, 42]. The authors (OKO, CJA, IIA, and OA) hand-searched the reference lists of the included articles.
+
+Data items
+
+A data extraction sheet, as outlined in the protocol by Onyeso et al. [17], was set up in Covidence and tested on a small sample of selected studies. The setup allowed two randomly paired reviewers (OKO, CJA, IIA, or MEK) to independently extract data, with OKO and CJA adjudicating any discrepancies. Consistent with the methodologies described by Lipsey and Wilson [43] and Khaliq et al. [44], we extracted key information from each study, including the first author’s surname, the year and country of publication, the study design (e.g., cohort, case-control, cross-sectional, or longitudinal), the sample size, the sociodemographic characteristics of participants, the mobility assessment tests used, and a descriptive summary of the outcomes. Additionally, we collected inferential statistical results, such as correlation and regression coefficients, effect sizes, standard errors, standard deviations, confidence intervals, and p-values.
+
+Risk of bias quality assessment
+
+Two reviewers (OKO and CJA) independently evaluated the Risk of Bias (ROB) using the 8-item Joanna Briggs Institute’s (JBI) ROB appraisal checklist for analytic cross-sectional studies [42] and met to resolve any conflict. This checklist helped in assessing the internal validity of the studies, examining aspects such as the clarity of inclusion criteria, descriptions of participants and settings, measures of exposure, conditions and outcomes, confounding factors, and statistical analysis. Each item was rated as “Yes = 1”, “Unclear = 0”, or “No = 0”. The overall risk assessment was conducted by assigning each study a score from 0 to 8, with the total scores used to classify the studies into three ROB categories: High (0–3), Medium (4–5), and Low (6–8).
+
+Data analysis
+
+The units of analysis were sociodemographic factors, mobility test, study design (cross-sectional and longitudinal studies), and type of inferential statistics (test of differences, bivariate, and multivariate association). A narrative synthesis was conducted to illustrate the direction of effects across all included studies. The synthesis for each sociodemographic factor was reported under the headings: bivariate analyses (including simple linear regression, Pearson’s correlation, and test of differences, such as t-test and analysis of variance [ANOVA]) and multivariate analyses.
+
+The meta-analysis included only studies that reported a bivariate association (zero-order correlation) between a sociodemographic factor and walking parameter or provided sufficient information to calculate these associations [31]. The Comprehensive Meta-Analysis (version 4) [45] and R software (version 4.3.2, ‘metafor’ and ‘robumeta’ packages) [46] were used for quantitative synthesis. The overall estimate was computed for studies with overlapping samples. In cases where studies reported effect sizes from independent subgroups, each subgroup was treated as a separate sample in the meta-analysis [47]. The effect sizes (correlation coefficients) were transformed to Fisher’s z-scores to adjust for normal distribution [46]. The inverse variance method was employed, which reduces the variance of the weighted average of effect sizes [47, 48]. The pooled mean effect size was then calculated using a random-effects model [47], which is suitable for drawing statistical inferences from studies of a heterogeneous population and generalising beyond the included studies [49]. The pooled estimates were presented using Forest plots.
+
+Heterogeneity was evaluated by visually examining the Forest plots, the p-value of Cochran’s Q test (p < 0.05), and the I2-statistic value. An I2 statistic of 0% indicates no heterogeneity, 50% indicates moderate heterogeneity, and 75% indicates high heterogeneity [50]. The influence analysis, Cook’s distance (D), was calculated to identify studies with overt dominance in the meta-estimates; a threshold of D > 0.5 was used to qualify a study as influential [46]. Where necessary, “one-study-removed” sensitivity analysis was applied to reduce subgroup heterogeneity, considering effect sizes outside the 95% confidence interval of the mean effect size as outliers [45]. Publication bias was assessed using three indicators: funnel plot, Rosenthal’s Fail-Safe N, and Egger’s regression intercept.
+
+Results
+
+Study selection
+
+The search across six databases yielded 17,170 results, of which 7,842 duplicates were removed. The PRISMA flowchart (Fig. 2) details the screening process of 9,328 abstracts, leading to the exclusion of 8,910 studies that did not meet the inclusion criteria. Seven of the remaining 428 articles could not be retrieved through the library’s collection or interlibrary loan. The 421 retrieved full texts were assessed, and 57 were selected for analysis. No additional articles were found through hand-searching their references.
+
+Fig. 2 PRISMA flowchart
+
+Study characteristics
+
+The studies were conducted across 25 countries between 1989 to 2023 (Fig. 3). The studies’ characteristics (Supplementary File 3) showed that 50 employed cross-sectional analyses, five were longitudinal, and two employed both designs. The review involved a total sample of 130,060 participants with a pooled mean ± SD age of 69.81 ± 7.21 years (95% CI: 69.77–69.85), ranging from 60.25 to 80.90 years. The sample was 58.2% women, 60.1% married, and 72.7% identified as Caucasian. The pooled average HGS = 1.01 ± 0.28 m/s (95% CI: 1.01, 1.05), range 0.52 to 1.37 and TUG = 7.67 ± 3.56 s (95% CI: 7.61, 7.73), range 5.71 to 12.6, reflected the general mobility status of the study populations. Table 1 summarised the narrative synthesis, indicating that 92.1% of the unique analyses found that older age was associated with mobility limitations. Other significant factors included being female (64.7%), non-Caucasian (62.5%), and having lower educational attainment (64.5%). Studies on marital status, area of residence, income, occupation, religion, homeownership, and social status were few and presented inconsistent results (Supplementary File 4). Only some studies addressing age and gender met the criteria for meta-analysis, as highlighted in the data analysis section.
+
+Fig. 3 Periods and countries where included studies were conducted
+
+Table 1 Summary of the narrative synthesis of the association between sociodemographic factors and mobility outcome
+
+Result	Cross-sectional analysis f(%)	Longitudinal analysis f(%)	Total f(%)	
+Bivariate	Multivariate	Bivariate	Multivariate	
+Age	
+ Older age → significantly lower mobility	39 (92.9)	26 (92.9)	2 (66.7)	4 (100.0)	71 (92.2)	
+ Younger age → significantly lower mobility	-	-	-	-	-	
+ The result was not statistically significant	3 (7.3)	2 (7.1)	1 (33.3)	-	6 (7.8)	
+Gender	
+ Men → significantly higher mobility	24 (63.2)	18 (66.7)	1 (33.4)	1 (50.0)	44 (62.9)	
+ Women → significantly higher mobility	1 (2.6)	-	1 (33.3)	-	2 (2.9)	
+ The result was not statistically significant	13 (34.2)	9 (33.3)	1 (33.3)	1 (50.0)	24 (34.2)	
+Marital status	
+ Married/has partner → significantly higher mobility	1 (100.0)	1 (50.0)	1 (100.0)	-	3 (75.0)	
+ Has no partner → significantly higher mobility	-	-	-	-	0 (0.0)	
+ The result was not statistically significant	-	1 (50.0)	-	-	1 (25.0)	
+Race	
+ Caucasians → significantly higher mobility	7 (77.8)	4 (100)	1 (33.3)	-	12 (75.0)	
+ Non-Caucasians → significantly higher mobility	1 (11.1)	-	-	-	1 (6.2)	
+ The result was not statistically significant	1 (11.1)	-	2 (66.7)	-	3 (18.8)	
+Education level	
+ Higher education → significantly higher mobility	14 (93.3)	6 (60.0)	-	-	20 (64.5)	
+ Lower education → significantly higher mobility	-	1 (10.0)	1 (33.3)	1 (33.3)	3 (9.7)	
+ The result was not statistically significant	1 (6.7)	3 (30.0)	2 (66.7)	2 (66.7)	8 (25.8)	
+Income level	
+ High income → significantly higher mobility	1 (50.0)	2 (100.0)	-	1 (100.0)	4 (80.0)	
+ Low income → significantly higher mobility	-	-	-	-	-	
+ The result was not statistically significant	1 (50.0)	-	-	-	1 (20.0)	
+Occupation type	
+ Manual job → significantly higher mobility	-	-	-	-	-	
+ Non-manual job → significantly higher mobility	2 (66.7)	-	-	-	2 (66.7)	
+ The result was not statistically significant	1 (33.3 )	-	-	-	1 (33.3 )	
+Area of residence	
+ Urban residents → significantly higher mobility	1 (100.0)	-	-	-	1 (50.0)	
+ Rural residents → significantly higher mobility	-	1 (100.0)	-	-	1 (50.0)	
+ The result was not statistically significant	-	-	-	-	-	
+Homeownership	
+ Homeowners → significantly higher mobility	-	-	-	1 (100.0)	1 (100.0)	
+ Non-homeowners → significantly higher mobility	-	-	-	-	-	
+ The result was not statistically significant	-	-	-	-	-	
+Social status	
+ High social status → significantly higher mobility	-	1 (100.0)	1 (100.0)	-	2 (66.7)	
+ Low social status → significantly higher mobility	-	-	-	-	-	
+ The result was not statistically significant	1 (100.0)	-	-	-	1 (33.3)	
+Religious participation	-	-	-	-		
+NB The total number of studies included was 57, but some analysed multiple independent datasets
+
+Study risk of bias
+
+The overall ROB of the included studies is presented in Fig. 4. Detailed ROB evaluations for each study are presented in Supplementary File 5. Among the 57 included studies, 51 (89.5%) exhibited a low ROB, while six (10.5%) demonstrated a moderate ROB, with none categorised under high risk of bias. The average ROB score was 7.
+
+Fig. 4 Joanna Briggs Institute’s checklist summary of the risk of bias of all included studies
+
+Associated sociodemographic factors
+
+Age
+
+Bivariate analysis
+
+Forty-nine of the 57 studies reported the influence of age on older adults’ mobility. Older age was significantly associated with slower HGS, as reported in 96.4% of the cross-sectional bivariate analyses [11, 13, 15, 32–35, 51–70]. Similarly, poorer TUG performance [51, 59, 68, 69, 71–75] and 6MinWT performance [59, 65, 72] were significantly associated with older age. However, three studies found no significant age-group difference in HGS [76] and TUG scores [69, 77]. Two longitudinal bivariate analyses reported a significant decline in TUG among the older age groups after six [78] and nine-year follow-ups [79], and no significant difference in HGS was found [78].
+
+Multivariate analysis
+
+Cross-sectional multivariate analyses showed that older age was significantly associated with slower HGS [11, 13, 32, 35, 36, 54, 56, 57, 59, 61, 63, 66, 68, 80–86], poorer TUG [59, 68, 73, 87, 88], and 6minWT performances [65]. Two cross-sectional studies found no significant multivariate association between HGS and age [67, 89]. However, longitudinal multivariate analyses showed a significant association between age and mobility (HGS and TUG) decline after a three-year [90, 91], five-year [92], and nine-year [79]follow-up.
+
+Meta-analysis
+
+The meta-analysis of 22 cross-sectional bivariate analyses (Fig. 5) showed that older age correlated significantly with slower gait speed. The pooled effect size (r) = -0.37 (95% CI: -0.42, -0.32), p < 0.001. Cochran’s Q = 253.68, p < 0.001, I2 = 92.1% suggests substantial heterogeneity among the studies. Rosenthal’s Fail-Safe (N) = 35.14 and Egger’s Regression Intercept (b) = -0.388, p = 0.763, show no evidence of publication bias. None of the studies overtly influenced the pooled estimate (D < 0.5).
+
+Fig. 5 Meta-analysis of the association between age and habitual gait speed
+
+The “one-study-removed” sensitivity analyses produced no significant difference in the heterogeneity indices. However, the simultaneous removal of seven studies [15, 51, 56, 62, 64, 68, 76] whose estimate fell outside the 95% CI, yielded a remarkable difference in heterogeneity, Q = 159.54, p < 0.001, I2 = 71.7% and effect estimate r = -0.42 (95% CI: -0.49, -0.38), p < 0.001. There was no statistical evidence of publication bias; Rosenthal’s N = 80.55 and Egger’s b = -0.448, p = 0.554.
+
+The meta-analysis of six studies reporting the effect of age on TUG (Fig. 6) showed a pooled effect size r = 0.31 (95% CI: 0.28, 0.34), p < 0.001, with a low heterogeneity Q = 5.73, p = 0.333, I2 = 0.1% and no statistical evidence of publication bias (Rosenthal’s N = 85.64 and Egger’s b = 0.292, p = 0.459). One study [75] with a high correlation coefficient (r = 0.81, n = 100) was excluded from the analysis as a severe outlier. The longitudinal analysis subgroups for HGS and TUG did not meet the criteria for meta-analysis.
+
+Fig. 6 Meta-analysis of the association between age and timed-up and go score
+
+Gender or sex at birth
+
+Bivariate analysis
+
+Forty-five of the 57 studies reported the effect of gender or sex at birth on older adults’ mobility. Most cross-sectional bivariate analyses reported significantly faster HGS for men compared with women [11, 13, 15, 33, 34, 54, 56, 57, 59–64, 70, 76, 86, 89]. However, Sprague et al. [15] found the reverse in a Japanese dataset. The rest of the studies found no significant difference [15, 32, 35, 52, 53, 58, 66, 67, 93, 94]. For walk distance, three studies reported that men covered longer distances during 6MinWT [59, 65, 72], but Kamiya et al. [65] result was not significant. Cross-sectional bivariate analyses showed that men had better TUG scores than women [59, 72, 73, 77], but two studies found the outcome not statistically significant [71, 75]. Two longitudinal bivariate analyses of HGS decline gave contrasting results. Gomes et al. [78] six-year follow-up found women, but Sialino et al. [14] 15-year follow-up found men to have more HGS decline. However, Gomes et al. [78] found no statistically significant gender differences in TUG decline.
+
+Multivariate analysis
+
+Most of the multivariate analyses showed that being a man was significantly associated with faster HGS [11, 13, 16, 36, 54, 56, 57, 59, 61, 63, 76, 80, 82, 94]. The remaining studies found no statistically significant gender effect [66, 67, 69, 83, 84, 89]. In terms of the time of completion of walking tasks, three cross-sectional analyses showed that being a man was significantly associated with a shorter time [59, 73, 87], while two studies found no significant gender association [69, 88]. Similarly, Thaweewannakij et al. [59] cross-sectional analyses found male gender as a significant predictor of a longer walking distance among older adults, while Kamiya et al. [65] found the same effect direction, but not statistically significant. In a 15-year longitudinal multivariate model, Sialino et al. [14] found a significant association between HGS decline and woman gender. Vasunilashorn et al. [91] reported no statistical significance after a three-year follow-up.
+
+Meta-analysis
+
+The meta-analysis of four cross-sectional bivariate studies suggested that being a woman was associated with slower HGS. The pooled effect size r = -0.13 (95% CI: -0.22, -0.03), p = 0.007 (Fig. 7). There was a moderate heterogeneity Q = 7.03, p = 0.071, I2 = 62.6%, and no statistical evidence of publication bias; Rosenthal’s N = 2.12 and Egger’s b = -0.011, p = 0.095. Only the cross-sectional bivariate HGS subgroup met the criteria for inclusion in the meta-analysis.
+
+Fig. 7 Meta-analysis of the association between gender and habitual gait speed
+
+Marital status
+
+Bivariate analysis
+
+Four of the 57 included studies reported the influence of marital status on mobility among older adults. A cross-sectional [34] and longitudinal [78] bivariate analysis reported that those who were married or with partners had significantly better HGS than those without partners or unmarried. Furthermore, Gomes et al. [78] reported that people with no partner had a more significant decline in TUG scores.
+
+Multivariate analysis
+
+Cross-sectional multivariate analyses conducted by Payne et al. [13] and Al Snih et al. [87] showed a positive influence of having a partner or being married on the HGS and 8ft walk test, respectively. Payne et al.‘s [13] result was statistically significant, but Al Snih et al. [87] was not.
+
+Race
+
+Bivariate analysis
+
+Twelve studies conducted a race-based analysis of mobility in older adults. Five bivariate cross-sectional analyses showed that Caucasians had significantly better HGS [11, 34, 36, 60, 84, 93], but a study reported no significant results [35]. Conversely, a study reported that the Japanese had better HGS than Caucasians [95]. Regarding timed walk tests, cross-sectional bivariate analysis [87] reported that Caucasians had significantly better 8ft WT scores than non-Caucasians. A six-year longitudinal analysis by Gomes et al [78] showed that Caucasians had a lesser but not statistically significant HGS and TUG decline. However, Thorpe et al [92] showed that Caucasians had significantly less HGS decline in a five-year longitudinal analysis.
+
+Multivariate analysis
+
+All the cross-sectional multivariate analyses – four studies reported that being a Caucasian was significantly associated with better HGS relative to other races, especially Blacks [11, 81, 84, 93]. No study reported a race-based longitudinal multivariate analysis.
+
+Education
+
+Bivariate analysis
+
+Twenty-two of the 57 studies reported the impact of education on mobility in older adults. About 93% of the cross-sectional bivariate analyses showed that higher education attainment was significantly associated with better HGS [32, 33, 35, 52, 54, 60, 61] and TUG scores [71, 96]. Additionally, Sprague et al. [15] analysed six datasets and found higher education associated with better HGS, except for a Nigerian dataset that showed no significant result. A six-year follow-up longitudinal bivariate analysis reported that people with higher education had a significantly higher HGS decline, but less and non-significant TUG decline [78]. Similarly, Idland et al. [79] reported that people with lower education had a lower TUG decline, but this was not statistically significant.
+
+Multivariate analysis
+
+Six cross-sectional multivariate analyses showed that higher education was significantly associated with better HGS [11, 33, 35, 36, 54] and TUG scores [87], but three studies found no significant association between educational attainment and HGS [13, 81, 84]. Conversely, Staples et al. [68] reported that higher education was associated with poorer TUG performance. A five-year longitudinal multivariate analysis showed that higher education was significantly associated with less HGS decline [92], while Vasunilashorn et al.‘s [91] three-year and Sialino et al.‘s [14] 15-year follow-up found no significant association.
+
+Income
+
+Bivariate analysis
+
+Five studies reported the influence of income on the mobility of older adults. One cross-sectional bivariate analysis reported that high-income earners had significantly better HGS than low-income earners [34], while another study found no significant association between income and HGS [32].
+
+Multivariate analysis
+
+Two cross-sectional multivariate analyses showed that high-income earners had significantly better HGS than low-income earners [11, 81]. A five-year longitudinal multivariate analysis showed that low income significantly predicted HGS decline [92].
+
+Occupation
+
+Three cross-sectional studies reported the association of manual (unskilled) and non-manual (skilled) jobs with mobility in older adults. Welmer et al. [33] (bivariate) and Plouvier et al. [12] (multivariate) reported significantly higher HGS in older adults with non-manual than manual occupations. However, bivariate analysis by Yaoxin et al. [71] found no significant job-type-related differences in TUG scores.
+
+Area of residence
+
+Two cross-sectional studies reported contrasting findings on the implications of urban and rural residence on older adults’ mobility. Compared to rural residents, urban residents had significantly higher HGS and 6MinWT scores in bivariate analyses [55] or slower gait speed within a multivariate-adjusted model [11].
+
+Homeownership
+
+One study reported a five-year follow-up longitudinal multivariate analysis showing that not owning one’s home was significantly associated with HGS decline [92].
+
+Social status
+
+Only three of the included studies reported the impact of social status on mobility. A cross-sectional bivariate analysis showed that people with higher social status had better HGS, though the outcome was not statistically significant [34]. However, a six-year follow-up longitudinal bivariate analysis reported a significant decline in HGS and TUG in older adults with low relative to high socioeconomic status [78]. Similarly, a 15-year follow-up longitudinal multivariate analysis showed that lower social participation was associated with significant HGS decline [14].
+
+Discussion
+
+The review examined the direction and magnitude of the association between sociodemographic factors and performance-based mobility outcomes among older adults. Concerning the direction of the association, the findings indicate that older age, female gender, single or unpartnered status, non-Caucasian race, lower education, and lower income were significantly associated with poorer mobility performance. Three or fewer studies addressed the impacts of occupation type, area of residence, homeownership, and social status; however, the findings across these studies were inconsistent, thus limiting our ability to draw reliable conclusions. No studies on religious participation met the inclusion criteria.
+
+Regarding effect magnitude, meta-analyses of cross-sectional bivariate results showed that older age and being a woman were moderately correlated with lower mobility scores. However, meta-analysis for other sociodemographic factors could not be conducted, as the included studies did not meet the required criteria: a sufficient number of studies reporting zero-order associations, using the same research design and statistical method, and comparable performance-based measures. Heterogeneity (I2-statistics) was negligible in the TUG-based meta-analysis for the effect of age (0.1%), but moderate in the HGS-based analyses for age (71.7% after outlier removal) and gender (62.6%). The TUG is generally considered a more stable measure of functional mobility in older adults than HGS [27, 97, 98]. Moreover, the higher heterogeneity observed in the HGS analyses may be attributed to variations in test calibration and protocols. For instance, although gait speed was consistently reported in metres per second, studies used walk paths of varying lengths, including 2.4 m [66], 3.7 m [67], or 4 m paths [69]. No evidence of publication bias was detected across analyses based on Egger’s test, Rosenthal’s Fail-Safe test, and visual inspection of funnel plots. Nevertheless, tests for publication bias could be imprecise when there are fewer than ten studies [99]. Therefore, the TUG-age and HGS-gender analyses should be interpreted with caution.
+
+From the life-course and SDH perspective, these results illustrate how cumulative social exposures and structural contexts shape functional capacity in later life [23, 26, 37]. The findings were interpreted through the lens of the socio-determinants of health, providing an alternative perspective to the biophysical models [100]. It is essential to note that three of the eleven sociodemographic factors in this review: age, sex, and race, can be explained through socially constructed and biophysical mechanisms. The physiological implications of old age, sex, and race have been well-established within the biophysical models; however, social scientists argue for a social perspective that addresses how the cumulative effects of ageism, sexism, and racism can be superimposed on the biophysical model.
+
+Human ageing naturally leads to biological decline, including mobility limitation. The strong association between age and mobility decline reflects not only biological ageing but also the lifelong accumulation of social and environmental constraints that limit opportunities for physical activity and health maintenance. Ageist actions, including the medicalisation of old age, older adult abuse and neglect, forced retirement, institutionalisation, and systematic exclusion during policymaking, can negatively impact the mobility potentials of older adults [101, 102]. Governments should develop national policies for healthy ageing, including social security, rights protection and caregiving support for older adults [103]. For example, incorporate standardised mobility assessments such as TUG, HGS, and balance tests into annual check-ups for older adults, enabling early detection of functional decline and fall risk [104]. Similarly, geriatric practice guidelines should integrate social prescribing modes that prompt clinicians to refer older adults to community-based physical activity programmes, walking groups, or intergenerational engagement initiatives that promote movement and reduce isolation.
+
+Sex- and gender-related findings align with the life-course concept of cumulative role strain. Sex differences in anatomy and physiology are evident, with biophysical impacts often emerging at older age [16, 105, 106]. Women often experience a double burden of domestic labour and occupational demands, resulting in sustained physical and psychosocial stress that may manifest as mobility limitations in later life. Some socioculturally constructed gender roles, including unpaid and unrecognised labour relating to childbirth, childrearing, housekeeping, and discriminatory practices, may predispose women to earlier mobility decline than men [14, 107]. To mitigate the life course impact of some socially constructed women’s work overload, we concur with Yavorsky et al. (2015) on the spousal division of labour. Formal interventions should target gender and work structures by supporting women through community groups, flexible workplace policies to lower maternal strain, and fair retirement benefits.
+
+Race is another social construct with biological intricacies. Some racial differences may have genetic basis in human senescence, but racism creates systematic disadvantages that can affect older adults’ mobility, as seen between American Blacks and Caucasians [92]. Racial and ethnic disparities in mobility can also be understood within the SDH framework as products of structural inequities. Differential access to education, income, and healthcare, together with systemic racism, can cumulatively disadvantage racialised groups, limiting their capacity to maintain physical function. In a multiracial society, Caucasians, especially males, often occupy positions of privilege, affording them better access to health, financial resources, social status, and a higher quality of life [108, 109]. Conversely, an older Black woman faces compounded discrimination due to ageism, sexism, and racism, creating additional structural disadvantages [92]. Beyond racism, racial identity aligns with cultural practices, such as dietary patterns [110], health-seeking behaviours [111] and beliefs on healthy ageing [112], which may influence older adults’ mobility. However, investment in education can mitigate the impacts of racism and cultural disparities through its effects on socioeconomic status and health literacy [111].
+
+Socioeconomic factors, including education [33, 113], occupation [12, 114], and income [115], affect mobility independently and collectively [116, 117]. Though socioeconomic factors may not have a direct biophysical effect, they influence mobility indirectly through psychological and sociobehavioural mediation on healthy ageing [117]. Educational disadvantage early in life can restrict occupational choice and income potential, leading to poorer living conditions and limited access to health-promoting environments, which in turn influences mobility in older adults [114]. Financial security is a vital factor in ageing experiences. Older adults with stable finances can afford essential health services, medications, balanced diets, mobility aids, tickets to recreational facilities, and social events [118]. Beltrán-Sánchez et al. [114] reported a significant influence of job type, education, and wealth on mobility in older adults, with emphasis on the negative impact of physically demanding jobs, even after controlling for age and sex. Thus, mobility disparities observed in older age partly represent the endpoint of a socially stratified trajectory rather than a purely biophysical process. The life course and SDH discourses [24, 25, 103] suggest that conducive sociopolitical environment, including formal education, employment opportunities, and social insurance, will enable healthy ageing, including mobility in later life.
+
+There was insufficient evidence regarding the influence of marital status, area of residence, homeownership, and social status, with fewer than four studies for each factor and inconsistent results, preventing a precise conclusion. For example, a study reported mixed results on the association between marital status and physical activities [100], while related literature reviews have shown the benefits of marriage for older adults, including companionship, co-caregiving, higher household incomes, life satisfaction, social participation, and better health [119]. Specifically, studies reported that married older adults had lesser mobility difficulties compared to unmarried [120, 121] and people who lost their spouses, especially widows [104, 122, 123]. Married individuals have more household income, access to care, housing, and social support, which can help them maintain physical activity and engagement in daily activities [120]. Widowed older adults may be encouraged to get a partner, cohabit, or coreside for companionship [120, 122] or actively engage in community-based social organisations for older adults as a way of maintaining mobility and healthy ageing. Government and private organisations may offer shared living and social services at subsidised fees for older adults with lower incomes.
+
+Home type and ownership affect mobility; homeowners and co-residents in shared living are generally more active due to home chores, while institutionalised older adults tend to be less mobile [92, 124, 125]. Rural and urban areas offer different benefits; rural areas provide natural environments (vegetation, water bodies, social and food security, quality air, and traffic safety) conducive to healthy ageing, while urban areas offer better access to healthcare and recreational services [55]. These contextual variations again reflect the SDH framework, in which environmental and infrastructural factors shape health opportunities. Government ageing policies should prioritise housing security and amenities to support healthy ageing in the community [126].
+
+Our review made obvious the paucity of studies on the association between performance-based mobility outcomes and religious participation. Few studies suggest that religious older adults have better mobility outcomes [127, 128], but none met the inclusion criteria for this review. Similarly, a systematic review of six studies [129] suggests a positive relationship between religiosity and better functional capacity in older adults, possibly due to social support, coping mechanisms, and a sense of purpose provided by religious beliefs and practices.
+
+Implications for future studies
+
+This study reveals significant gaps in the literature, including the paucity of studies with a specific objective of examining the sociodemographic factors in mobility trajectory across the life course. Standardising sociodemographic categories in observational studies, such as consistent categorisation of education by years of schooling or levels of educational attainment, would facilitate cross-study comparisons and meta-synthesis of research findings. Reporting both bivariate and multivariate outcomes would allow a better understanding of the crude and adjusted effects of the factors. Longitudinal studies are encouraged, where feasible, to establish modifiable sociodemographic determinants of performance-based mobility outcomes. Longitudinal studies can also facilitate analysis of sociodemographic interactions in mobility decline trajectory and identify the effect of changes in sociodemographic statuses, such as moving from widowed to married and vice versa. Future research could incorporate intersectionality within the SDH framework, considering that age, race, gender, education, occupation, income, residential area, housing type, and social status may collectively shape individual health trajectories through complex interactions.
+
+Policy and clinical implications
+
+Ageing is a universal process, making older adults’ health a societal and policy priority. Addressing ageism and structural inequities requires a cultural reorientation that embeds social justice within health policy [101]. Equity-driven approaches must explicitly address sociodemographic disparities to ensure fair distribution of national resources, infrastructure, and welfare supports that mitigate mobility decline and assist those with functional limitations [28]. The World Health Organization (WHO) SDH framework underscores that equitable access to education, economic opportunities, social services, housing, preventive care, and culturally responsive mobility interventions is critical to narrowing these inequities [24].
+
+Consistent links between lower education, female gender, and racialised status with poorer mobility outcomes highlight the need for targeted screening and intervention [16, 33, 92]. Health systems should integrate risk-stratified mobility assessments such as the TUG into routine check-ups for older adults with less than secondary education, women over 60 years, and individuals from Indigenous, Black, and other marginalised groups. Early identification of functional decline in these subpopulations enables timely referral to rehabilitation and wellness programmes [104].
+
+Community-based interventions should dismantle structural barriers to social participation, in line with the United Nations and WHO Decade of Healthy Ageing (2021–2030) initiative [130]. In this light, federal, provincial, and municipal governments can fund culturally tailored social services and activity centres, particularly in low-income areas, offering social engagement programmes, job opportunities, transport vouchers, food pantries, and free intergenerational fitness sessions to promote healthy ageing. Partnering with faith-based organisations, settlement agencies, and older adults’ associations enhances outreach, trust, and cultural resonance.
+
+The United Nations assesses how Member States incorporate ageing into social development and recommends policy priorities such as strengthening care systems and integrating social prescribing in primary health care [131]. Clinicians working in areas with significant inequity should have defined referral processes for subsidised social services, fitness programmes, mobility devices and technology, and peer-led groups, based on cultural preferences.
+
+Long-term policies must address life-course determinants of mobility, as outlined in the WHO Age-Friendly Cities and Communities framework [132]. Regional development strategies should foster accessibility, engagement, autonomy, and opportunities for lifelong learning. Investments in adult education, vocational training, and flexible employment can reduce cumulative socioeconomic disadvantage. Integrating clinical screening, community programmes, and socioeducational reforms provides a coherent pathway to equitable healthy ageing and sustained functional independence among older adults.
+
+Limitations
+
+The strength of our study lies in its methodological rigour. However, its limitations include the restriction to English-language articles. Further limitations arise from our focus on older adults with non-specific disease profiles. Although this approach reduced potential confounding, it limits the generalisability of our findings to apparently healthy older adults. In addition, while some multivariate models included comorbidity, the construct was inconsistently defined and typically operationalised as a dichotomous indicator or simple count rather than as disease-specific conditions. This lack of specificity restricted our ability to meaningfully incorporate comorbidity into the analysis. For these reasons, and because covariate adjustment varied widely across studies, we excluded multivariate coefficients from the meta-analysis to avoid undermining comparability and introducing bias into pooled estimates.
+
+Consequently, only bivariate coefficients were synthesised to maintain analytical consistency, albeit at the expense of accounting for potential confounding. However, the paucity of studies and variations in mobility outcomes and statistical analyses prevented a meta-analysis on marital status, education, income, occupation, homeownership, religion, social status, area of residence, and race. For the meta-analyses, we aggregated correlation coefficients, which do not imply causality [47]. The HGS-based meta-analysis (Figs. 5 and 7) should be interpreted with caution, as variations in the walking paths employed (e.g., 2.4 m, 3.7 m, 4 m) contributed to high heterogeneity (I²) values. Additional caution is warranted when interpreting publication bias estimates for the meta-analyses presented in Figs. 6 and 7, since such estimates could be imprecise when fewer than ten studies are available [99].
+
+Finally, although the review spans the entire period since MEDLINE’s inception in 1947 and provides a comprehensive historical synthesis, the final search was conducted on 27 November 2023. As a result, the most recent publications may not have been captured. However, checks of publicly available sources did not identify new evidence that would be expected to alter our conclusions.
+
+Conclusion
+
+This review elucidates the multifaceted determinants of mobility limitation in older adults, highlighting the significant roles of age, gender, race, and education. While biological ageing inherently affects mobility, social factors like age, gender roles, racial identity, and socioeconomic disparities could influence mobility trajectories. The limited research on the impact of marital status, homeownership, religion, income, occupation, social status, and area of residence underscores the need for comprehensive studies that consider the broad spectrum of sociodemographic factors. Addressing these gaps will enrich our understanding of the sociodemographic influences on mobility in older adults and guide the development of targeted interventions and policies to support active ageing.
+
+Supplementary Information
+
+Supplementary Material 1.
+
+Abbreviations
+
+10MWT Ten-metre Walk Test
+
+6MinWT Six-Minute Walk Test
+
+CINAHL Cumulative Index to Nursing and Allied Health Literature
+
+CMA Comprehensive Meta-Analysis
+
+EMBASE Excerpta Medica Database
+
+HGS Habitual Gait Speed
+
+JBI Joanna Briggs Institute
+
+MEDLINE Medical Literature Analysis and Retrieval System Online
+
+MeSH Medical Subject Headings
+
+MOOSE Meta-analysis of Observational Studies in Epidemiology
+
+PRISMA Preferred Reporting Items for Systematic Review and Meta-Analysis
+
+PROSPERO International Prospective Register of Systematic Reviews
+
+ROB Risk of Bias Assessment
+
+SDH Social Determinants of Health
+
+SPPB Short Physical Performance Battery
+
+TUG Timed Up and Go
+
+UG 8-Foot Up-and-Go
+
+WHO World Health Organisation
+
+Acknowledgements
+
+We are thankful to our research assistants UpJesus Onwuasoanya, Ernest Ugwu, Innocent Nwabueze, Moses Igattah, Mabel Kelechi Odo, Ebunoluwa Bankole, Oluwasijibomi Akinwusi, Motunrayo Odunayo, Morayo Olufemi-Phillips, Omowumi Famurewa, Oluchi Okpara, and Suha Damag.
+
+Authors’ contributions
+
+OKO and OAA conceived this study. OKO, DRS, CJA, MEK, IIA, OA, KMO, ACO, JV, JD, and OAA designed the study. OKO and DRS developed the search strategy. DRS completed the literature search and deduplication. Each author participated in article screening, data extraction, or risk of bias assessment. OKO, CJA, DRS, MKO, and OAA drafted the manuscript. All authors gave critical input to the final manuscript and approved it for publication. OKO serves as the guarantor of the manuscript.
+
+Funding
+
+There was no external funding for this study.
+
+Data availability
+
+The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
+
+Declarations
+
+Ethics approval and consent to participate
+
+Not applicable.
+
+Consent for publication
+
+Not applicable.
+
+Competing interests
+
+The authors declare no competing interests.
+
+Publisher’s Note
+
+Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
+
+
+References
+
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+Coppin AK, Ferrucci L, Lauretani F, Phillips C, Chang M, Bandinelli S, Guralnik JM. Low socioeconomic status and disability in old age: evidence from the Inchianti study for the mediating role of physiological impairments. J Gerontol Biol Sci Med Sci. 2006;61(1):86–91.10.1093/gerona/61.1.86 16456198
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+Hossain B, Yadav PK, Nagargoje VP, Vinod Joseph KJ. Association between physical limitations and depressive symptoms among Indian elderly: marital status as a moderator. BMC Psychiatry. 2021;21(1):573.34781925 10.1186/s12888-021-03587-3 PMC8594119
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diff --git a/corpus/healthcare/text/f2aa3d5d2fc2d406.txt b/corpus/healthcare/text/f2aa3d5d2fc2d406.txt
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@@ -0,0 +1,360 @@
+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Nutrients
+Journal ID: Nutrients
+NLM Journal ID: 101521595
+Journal ID: nutrients
+
+Nutrients
+
+EISSN: 2072-6643
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13363228
+PMID: 42451127
+DOI: 10.3390/nu18132123
+Article ID: nutrients-18-02123
+Article version: 1
+Subjects: Systematic Review
+
+Clinical Outcomes on Home Parenteral Support for Patients with Benign Chronic Intestinal Failure: Systematic Review and Meta-Analysis
+
+https://orcid.org/0000-0003-3448-9476 Eckhardt Maja 1 2 *
+https://orcid.org/0000-0002-4967-647X Burden Sorrel 1 2
+McGowan Eilidh 1
+Carlson Gordon L. 1 2
+https://orcid.org/0000-0002-1773-8330 Pironi Loris 3
+Lal Simon 1 2
+Dickerson Roland N. Academic Editor
+1 Intestinal Failure Unit, Northern Care Alliance NHS Foundation Trust, Salford M6 8HD, UK; sorrel.burden@manchester.ac.uk (S.B.); eilidh.mcgowan.10@gmail.com (E.M.); gordon.carlson@nca.nhs.uk (G.L.C.); simon.lal@nca.nhs.uk (S.L.)
+2 School of Health Sciences, University of Manchester, Manchester M13 9PL, UK
+3 Department of Medical and Surgical Sciences, University of Bologna, 40126 Bologna, Italy; loris.pironi@unibo.it
+* Correspondence: maya.kopczynska@gmail.com; Tel.: +44-1612064521
+Electronic publication date: 2026 Jul 1
+Publication date: 2026 Jul
+Volume: 18
+Issue: 13
+Electronic Location ID: 2123
+Received 2026 Jun 7; Revised 2026 Jun 23; Accepted 2026 Jun 27
+Copyright: © 2026 by the authors.
+Copyright year: 2026
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: intestinal failure, home parenteral support, mortality, nutritional autonomy
+
+Funding: This research received no external funding.
+
+Ÿ==============================Ÿ
+Background/Objectives: Chronic intestinal failure (IF) necessitating home parenteral support (HPS) represents an end-stage condition for many gastrointestinal diseases. While long-term outcomes have been reported in HPS-dependent patients, there are limited generalisable data on survival and nutritional autonomy rates in large contemporary cohorts. The primary objective of this study was to examine the evidence on mortality and nutritional autonomy rates for HPS published to 2025. Methods: This is a systematic review and meta-analysis (PROSPERO Registration number: CRD42025645325). A database search was conducted up to 3 February 2025. Studies assessing survival and nutritional autonomy in adults with benign chronic IF receiving HPS were included. For clinical outcomes, crude proportions were calculated and a meta-analysis was performed to calculate the proportion affected per year of follow-up, with survival probabilities additionally presented on Kaplan–Meier curves. Results: Overall, 3411 records were screened and 57 studies were included. The overall mortality was 8.0% per year of follow-up (95% CI 6.0 to 10.0%), or 33.5% over a mean of 49.02 months. The summary of survival curves estimated the pooled five- and ten-year survival rates from HPS initiation as 68.71% and 52.46%, respectively. Nutritional autonomy was achieved in 35.3% of patients, at a rate of 10.0% per year of follow-up (95% CI 7.0% to 14.0%). Age, gastrointestinal anatomy, and underlying disease leading to IF were identified as potential factors associated with mortality and nutritional autonomy. Conclusions: This is the first systematic review and meta-analysis summarising the current literature on survival and nutritional autonomy in adults with chronic IF. These findings increase our understanding of this complex condition, providing baseline data to support clinical decision-making and patient counselling.
+
+1. Introduction
+
+Intestinal failure (IF) is a complex and debilitating condition defined as the inability of the gut to absorb sufficient macronutrients, electrolytes, and water to sustain life, such that intravenous supplementation or ‘parenteral support’ is required [1]. Before the late 1960s, a diagnosis of IF was considered incompatible with life; however, the subsequent development of intravenous nutrition has transformed IF care [2]. Intestinal failure can be classified according to functional, pathophysiological, and clinical features: type 1 is an acute, short-term, and usually self-limiting condition; type 2 is a prolonged acute condition, typically in metabolically unstable patients following surgery, which may last for weeks or months; type 3, or chronic IF, describes the need, reversible or irreversible, for long-term parenteral support in metabolically stable patients [1,3].
+
+The pathophysiological mechanisms leading to chronic IF include short bowel syndrome (SBS), gastrointestinal dysmotility, intestinal fistulae, mechanical obstruction, and extensive mucosal disease and can result from a variety of underlying conditions, such as Crohn’s disease, mesenteric ischaemia, surgical complications, or chronic intestinal pseudo-obstruction [1]. Indeed, given its complexity, chronic IF is often considered to be the end-stage of many gastrointestinal diseases, requiring cohesive and specialised multi-disciplinary input for safe long-term care [4,5]. Thus, ideally, patients with chronic IF should be able to receive parenteral support at home (termed ‘home parenteral support or HPS’), which typically involves administering intravenous solutions via a pump over 10 to 14 h, between two and seven nights per week.
+
+In Europe, the prevalence of chronic IF due to benign disease has been estimated to range from 5 to 80 cases per million of the national population, and it has been steadily increasing over the last four decades, due to both increased awareness and advances in the surgical management and critical care of patients [4,6]. However, there remains global inequity of access to HPS and, in many countries worldwide, no treatment options at all for patients with chronic IF [7]. Where treatment is available, it is recognised that the approach to delivery of care for patients with chronic IF differs both within and between countries, which has an impact on long-term patient outcomes [8,9]. Monitoring and reporting of the outcomes are crucial since, although essential for life, the impact of HPS on both the individual [10] and the healthcare economy is high [11]. Indeed, complications include those associated with the central venous catheter, such as catheter-related bloodstream infections or thrombosis, as well as IF-associated liver disease and metabolic bone problems [12,13,14]. Moreover, treatment with HPS has been shown to have a substantial negative impact on patients’ quality of life due to the highly regimented lifestyle required [15,16]. Overall, the cost of HPS in adult patients in Europe has been estimated as between €13,000 and €71,000 per year, including HPS bags cost, personnel cost, and/or consumables cost [11].
+
+Historical cohort studies have reported 5-year survival probabilities of between 58% and 83% for patients on HPS [17,18,19,20]. Previous research also shows that chronic IF is associated with more than seven-fold higher mortality rates than for the general UK population and shorter life expectancies by more than 17 years [18]. Nevertheless, despite increased awareness of this condition and its complications, as well as advances in novel therapies, there are no recent comparisons between patient outcomes among centres. Indeed, the most recent narrative review describing the probability of survival and nutritional autonomy in adults with chronic IF included studies only up to 2011 [21]. In addition, the latter review was not performed systematically and did not include a meta-analysis, and pooled survival and nutritional autonomy estimates were not calculated. Importantly, since its publication, there have been developments in data interpretation that raise questions about the optimal study design for the correct derivation and interpretation of the analysis of outcomes in patients with chronic IF [22].
+
+The primary aim of this systematic review and meta-analysis was therefore to examine the evidence published up to 2025 on mortality and nutritional autonomy in HPS-dependent patients with chronic IF due to benign disease. The secondary aim was to examine the evidence on factors associated with increasing the rate of these clinical outcomes, as well as evidence on the primary causes of death in this patient cohort.
+
+2. Materials and Methods
+
+2.1. Reporting Guidelines and Protocol Registration
+
+This systematic review and meta-analysis followed the PRISMA 2020 guidance for reporting systematic reviews. The PRISMA 2020 checklist can be found in Supplementary Table S1. In accordance with the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 29 January 2025 (Registration number: CRD42025645325).
+
+2.2. Eligibility Criteria
+
+Population: We included observational studies including cohort and cross-sectional studies that studied adult patients with benign chronic IF receiving HPS. Clinical trials were excluded because they include highly selected samples of patients, frequently undergoing additional tests or interventions, including promoting weaning off HPS with medication, making their results less comparable to general cohorts of patients with IF. Studies with individuals all under the age of 18 were excluded. If the underlying disease leading to IF in the included subjects was benign for more than 80% of participants, or if data were able to be extracted for the subgroup of participants with benign aetiology of IF, these studies were included.
+
+Exposures: Exposures that included the provision of HPS.
+
+Outcomes: The outcomes included mortality and regaining nutritional autonomy. Patients were classified as having achieved nutritional autonomy if they remained off HPS for a period of 12 months or, if these data were not available, when defined by the authors as “weaned off HPS.” Additional outcomes included factors associated with mortality and nutritional autonomy, as well as primary causes of death categorised as IF-related, underlying disease-related, non-HPS/non-IF-related, or unknown. No attempt was made to associate nutritional autonomy with glucagon-like peptide 2 therapies. Outcomes were extracted as reported in all included studies and in all data forms using a pre-defined data extraction form.
+
+Setting: Studies taking place only in home settings were included. Studies taking place in the hospital setting were excluded.
+
+Years, Language, and Publication Status: There were no publication date restrictions. Articles reported in any language and describing original research published in peer-reviewed scientific journals were included.
+
+2.3. Information Sources and Search Strategy
+
+Searches were conducted up to 3 February 2025. The databases included MEDLINE (Ovid interface, U.S. National Library of Medicine), EMBASE (Ovid interface, Elsevier), and Web of Science (Clarivate Analytics interface, Clarivate). To ensure literature saturation, PROSPERO was searched for any ongoing or completed reviews. The reference lists from all relevant reviews were searched. Additionally, the reference and citation lists of all included studies were manually screened to identify any other relevant articles. Literature search strategies were developed using medical subject headings (MeSH) and text words related to intestinal failure, home parenteral support, mortality, and nutritional autonomy. The full search strategy can be found in Supplementary Figure S1.
+
+2.4. Selection Process
+
+Two reviewers (M.K. and E.M.) independently screened the titles and abstracts to exclude irrelevant studies. The full text was obtained for any studies that met the inclusion criteria or where there was any uncertainty. The full texts were then assessed for the inclusion/exclusion criteria. Disagreements between the reviewers were resolved through discussion and arbitration with a third author (S.L.) if necessary. We did not need to contact any study authors to clarify eligibility. The reasons for excluding studies were noted.
+
+2.5. Data Collection Process
+
+The literature search results were uploaded to Rayyan software version 1.7.5 (web application) for organisation and screening. Any duplicates were identified and removed automatically and then manually in Rayyan software. Summary estimate data were extracted from the included studies using a standardised data extraction form, developed a priori. Extracted variables included centre, country, study years, inclusion and exclusion criteria, study design, sample size, mean patient age, proportion of male patients, median and range of HPS duration, mortality rate, nutritional autonomy rate, and causes of death. Data extraction was carried out by one reviewer (M.K.) and then verified by another (E.M.) to reduce bias and errors.
+
+2.6. Data Outcomes
+
+The main outcomes of interest were mortality and nutritional autonomy. These were measured as the number of events per year of follow-up. Data on reported associations of clinical outcomes were extracted from each included study, and whether associations had been established using a univariate or multivariate analysis. The data on mechanism and underlying disease leading to IF were extracted as reported in the studies. Short bowel syndrome was frequently sub-classified in the studies based on the remaining gastrointestinal anatomy as group 1 (small bowel end-ostomy), group 2 (jejunocolic anastomosis), and group 3 (jejunoileocolic anastomosis with intact ileocecal valve and colon) [1]. Other extracted data included author, study years, country, IF centre name, study design, sample size, mean age, sex, duration of follow-up, duration of HPS treatment, and causes of death.
+
+2.7. Study Risk-of-Bias Assessment
+
+Two reviewers (M.K. and S.B.) independently assessed the risk of bias by applying the Risk of Bias in Non-Randomised Studies of Exposures (ROBINS-E) tool. The judgement was either ‘Low’ or ‘High’ risk of bias, or ‘Some Concerns’.
+
+2.8. Effect Measures and Synthesis of Data
+
+To reduce the risk of duplication of patients in the meta-analysis, studies were selected for inclusion if their reported patient outcomes did not overlap with those of other reported cohorts. The author names, centre names and locations, and years of inclusion were compared such that only non-overlapping cohorts were included in the meta-analysis.
+
+We only conducted meta-analyses if there were studies reporting similar comparisons for the outcome measures. For clinical outcomes (mortality and nutritional autonomy), crude proportions were calculated and then meta-analysis was performed to calculate the proportion affected per year of follow-up. Random effects were used throughout, with 95% CIs. Heterogeneity was calculated according to Cochrane’s Q statistic and its related metric I2. Analysis was performed using the R package meta version 8.2-1 in R Version 4.5.2.
+
+Additionally, a summary of survival probabilities presented on Kaplan–Meier curves was undertaken using the method described by Combescure et al. [23]. In brief, the survival probabilities were read from the survival curves from the time of the HPS initiation until the end of follow-up. For this purpose, the pictures of the curves were digitalised, and the probabilities were extracted using the package SurvdigitizeR version 0.0.0.9000. Then, the numbers of at-risk patients during the different time intervals were assessed from the total sample size, number-at-risk patient tables, and survival probabilities using the R package IPDfromKM version 0.1.10. Finally, the MetaSurvival version 0.1.0 method was applied over a follow-up of ten years with random effects, with 95% CIs to visualise the summarised survival curves.
+
+3. Results
+
+3.1. Study Selection
+
+We found a total of 4992 records from searching the databases and, after removing duplicates, 3411 records were screened. From these, 305 full-text documents were reviewed, and 74 reports were included. Additionally, a further 64 records were identified from scanning the reference lists of initially included studies and relevant prior reviews. After checking for duplicates, we reviewed the 64 additional reports and included 14, resulting in a total of 88 included records. These represented 57 separate adult study populations [6,9,18,19,20,22,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74], due to some cohorts overlapping. When multiple reports were published on one cohort, only the most recent or complete report was included. There were a further six papers that reported data concerning risk factors for mortality [75,76] and nutritional autonomy [77,78] as well as cause of death [79,80] that were not published in the primary article arising from that study, meaning that we extracted data from 63 separate articles in total. The PRISMA flow diagram, including the reasons for reports’ exclusion, can be viewed in Figure 1.
+
+3.2. Study Characteristics
+
+The characteristics of the included studies are presented in Table 1. Included studies were from Argentina (n = 1) [69], Australia (n = 1) [32], Belgium (n = 1) [51], Brazil (n = 1) [56], Canada (n = 1) [68], China (n = 1) [61], Denmark (n = 5) [6,22,37,46,59], France (n = 6) [20,24,38,39,52,55], Italy (n = 4) [43,47,53,72], Japan (n = 4) [31,35,57,66], the Netherlands (n = 2) [58,63], Portugal (n = 2) [71,73], Spain (n = 1) [45], the UK (n = 9) [18,27,30,34,44,49,54,67], the USA (n = 12) [25,26,29,33,40,42,48,50,64,65,70,74], Europe (n = 4) [28,36,41,60], and worldwide (n = 2) [9,62]. In terms of study design, the vast majority (50 out of 57) were retrospective cohort studies [6,9,18,19,20,22,25,26,28,29,30,31,32,33,34,36,37,38,39,40,41,42,43,44,45,46,47,48,49,51,52,53,55,56,57,58,59,60,61,62,64,65,66,67,70,71,72,73,74], six were prospective cohort studies [24,27,54,63,68,69], and one a retrospective cross-sectional study [35]. The majority of the studies (36 out of 57) included mixed populations of patients with different mechanisms leading to chronic IF [6,9,18,19,24,25,26,27,28,30,32,34,35,36,37,39,40,41,43,44,45,46,47,48,49,50,51,53,54,56,58,62,63,67,71,72], twelve studies included only patients with chronic IF due to SBS [22,31,38,42,55,59,61,65,68,69,70,73], five only patients with chronic IF due to Crohn’s disease/inflammatory bowel disease [33,52,57,64,66,74], one only patients with chronic IF due to chronic intestinal pseudo-obstruction [20], one only patients with chronic IF due to post-bariatric complications [60], and one only patients with chronic IF due to scleroderma [29].
+
+Overall, 34 studies were single- [6,18,19,22,25,27,29,30,31,32,33,39,40,42,43,44,48,49,50,51,55,56,58,59,61,63,64,65,66,70,71,72,73,74] and 23 were multicentre [9,20,24,26,28,34,35,36,37,38,41,45,46,47,52,53,54,57,60,62,67,68,69]. Forty studies reported the mean patient age at HPS initiation, ranging from 20 to 64 years [6,9,18,19,20,22,24,28,32,33,35,38,39,40,43,44,45,46,47,48,49,50,51,54,55,57,58,59,60,61,62,63,65,66,67,69,71,72,73,74]. Twenty-four studies reported the mean duration of HPS, ranging from 7.2 to 97.6 months [6,18,22,24,29,32,33,34,35,43,46,47,49,53,54,58,59,61,63,64,68,69,71,72]. The study period investigated by the included studies is presented in Supplementary Figure S2. The mean duration of the included studies was 17 years (range 1–45 years).
+
+3.3. Mortality
+
+Overall, 27 studies reported a number of deaths over a mean follow-up period [6,18,19,20,22,25,29,31,32,33,38,40,43,47,51,54,55,58,64,65,66,67,68,69,71,72,74]. In all of the studies, patient baseline enrolment was at the time of starting HPS. The overall mortality of patients with chronic IF was 8.0% per year of follow-up (95% CI 6.0 to 10.0%) (Figure 2), or 33.5% (1747/5212) over a mean of 49.02 months of follow-up, with high heterogeneity between studies (I2 = 89.6%, p < 0.001). The mortality in patients from mixed populations was 11.0% per year of follow-up (95% CI 10.0% to 13.0%, I2 = 80.3%, p < 0.001), in patients with chronic IF due to Crohn’s disease it was 3.0% per year (95% CI 1.0% to 8.0%, I2 = 70.0%, p = 0.02), and in patients with chronic IF due to SBS it was 6.0% per year (95% CI 4.0% to 8.0%, I2 = 91.7%, p < 0.001) (Figure 2). Subgroup analyses of overall mortality by centre size, type of follow-up, and reported risk of bias in studies are presented in Supplementary Figure S3.
+
+Twelve studies presented survival curves with follow-up from the initiation of HPS to end of the follow-up, ranging from a maximum of five to forty years [18,20,22,38,43,53,54,55,56,62,68,69]. Two studies were excluded from the analysis due to unreadability of the survival curves [53,69]. The summary of the survival probabilities over time is presented in Supplementary Table S2 and Figure 3. The decline in survival was more pronounced during the initial five years of follow-up (~6–7% mortality per year) compared to the following years (~2–4% mortality per year). Overall, three studies followed patients until HPS cessation [43,62,68]; in the rest of the studies, patients were followed up until death or the end of the study period [18,20,22,38,54,55,56].
+
+3.4. Factors Associated with Mortality
+
+Due to a small number of studies investigating potential risk factors using the same definitions and methods, a meta-regression of factors associated with mortality was not possible. The summary of factors with positive and negative association reported by the included studies is presented in Supplementary Figure S4. A frequently reported factor associated with mortality was older age, which was identified as a significant risk factor in thirteen studies [18,19,20,22,24,37,38,40,43,55,62,72,75]. Seven studies applied age cut-offs for the analysis (e.g., age ≥ 60 years) [9,20,22,24,37,38,62], and six studies used age as a continuous variable [18,19,40,43,72,75]. Another frequently considered risk factor was gastrointestinal anatomy. Shorter small bowel lengths were reported to be associated with increased mortality in five studies [37,38,40,65,72]. The presence of colon-in-continuity (one study [19]) and restoration of gastrointestinal tract continuity (two studies [65,72]) were reported to be negatively associated with mortality. The associations between the pathological conditions leading to chronic IF and mortality were also evaluated by several studies. The most frequently reported factors associated with increased mortality among the underlying diseases leading to chronic IF were mesenteric ischaemia (eight studies [9,18,19,22,38,54,55,72]), systemic sclerosis (two studies [20,76]), and radiation enteritis (two studies [18,19]). Crohn’s disease leading to chronic IF was associated with reduced mortality in three studies [37,62,76]. Regarding the mechanisms leading to chronic IF, SBS-group 1 (two studies [38,55]), chronic obstruction (two studies [9,19]), and fistulae (two studies [9,19]) were reported to be associated with increased mortality. Long-term HPS dependence was also associated with increased mortality in four studies [18,22,38,55]. Other identified factors presented in Supplementary Figure S4 were reported by single studies.
+
+3.5. Causes of Death
+
+Cause of death was reported in 34 studies [9,18,20,24,26,29,31,32,34,37,38,39,40,43,44,45,46,47,48,49,51,52,55,61,62,63,66,67,68,69,73,79,80]. The main causes of death were non-IF/non-HPS-related (45.6%), followed by underlying disease (35.2%) and IF-related death (12.2%); 7.1% of deaths had an unknown cause. Overall, 5.1% of deaths were due to catheter-related bloodstream infection, 0.5% due to central venous catheter thrombosis, 3.9% due to IF-associated liver disease, and 2.5% due to unspecified IF-related causes.
+
+3.6. Nutritional Autonomy
+
+Overall, 22 studies reported the number of patients who regained nutritional autonomy over a mean follow-up period [6,18,20,22,25,29,31,32,33,38,40,43,47,51,54,55,58,65,67,68,71,72]. Nutritional autonomy was achieved in 35.3% (1318/3736) of patients, at a rate of 10.0% per year of follow-up (95% CI 7.0% to 14.0%), with high heterogeneity between studies (I2 = 91.2%, p < 0.001) (Figure 4). In mixed populations of patients with chronic IF, nutritional autonomy was achieved at rate of 14.0% per year of follow-up (95% CI 9.0% to 21.0%, I2 = 89.0%, p < 0.001), and in patients with chronic IF due to SBS at 7.0% per year (95% CI 4.0% to 11.0%, I2 = 94.3%, p < 0.001) (Figure 4). Overall, only three studies [22,72,77] used death as a competing risk in the analysis of the regaining nutritional autonomy rate. Subgroup analyses of regaining nutritional autonomy by centre size, type of analysis, and reported risk of bias in studies are presented in Supplementary Figure S5.
+
+3.7. Factors Associated with Regaining Nutritional Autonomy
+
+The challenges in analysing the factors associated with nutritional autonomy were similar to those described in the mortality section; thus, only the summary of factors with positive and negative associations reported by the included studies is presented (Supplementary Figure S6). The most frequently reported factors associated with regaining nutritional autonomy were based on gastrointestinal anatomy. Increased length of the small bowel was associated with increased likelihood of regaining nutritional autonomy in five studies [38,52,72,77,78]. Additionally, increased length of the colon (two studies [72,78]), colon-in-continuity (two studies [77,78]), ileocaecal valve presence (one study [65]), and reconstructive surgery after HPS initiation (one study [72]) were reported to be associated with increased likelihood of nutritional autonomy. Regarding the mechanisms leading to chronic IF, SBS-group 1 and SBS-group 2 were negatively associated with achieving nutritional autonomy, in contrast to SBS-group 3 in three studies [22,38,72]. Moreover, chronic intestinal pseudo-obstruction (CIPO) was associated with decreased likelihood of nutritional autonomy in two studies [20,62]. Older age at HPS initiation was also reported to be associated with decreased likelihood of achieving nutritional autonomy in three studies [9,72,77]. Other identified factors presented in Supplementary Figure S6 were reported by single studies.
+
+3.8. Risk of Bias in Studies
+
+The Risk of Bias in Non-Randomised Studies of Exposures tool was used to assess the risk of bias in the included studies. The detailed appraisal is presented in Supplementary Figure S7. In terms of overall quality, 17 studies had a low risk of bias [9,18,27,33,34,35,40,47,52,57,58,59,63,66,67,71,72], 32 studies had some concerns of bias [6,19,22,24,25,29,30,31,32,37,38,39,42,43,44,45,46,48,49,53,54,55,56,62,64,65,68,69,70,74], and nine studies had a high risk of bias [26,36,41,50,51,60,61,73]. Some concerns were raised regarding confounding, as few studies included detailed assessment of its impact on the measured outcomes. Some concerns were raised due to temporal bias in relation to exposure to HPS, as it is likely that not all patients were treated with the same HPS preparations over time. Concerns were also raised regarding censoring, as patients could have been censored upon death, the end of the study date, ceasing HPS, or receiving alternative treatment such as a small bowel transplant. Some concerns were raised with the reporting of missing data, with few studies reporting external checks on validity. Additionally, no study protocols were available to assess selection bias in reporting.
+
+4. Discussion
+
+This study presents the first systematic review of the current literature on survival and the ability to regain nutritional autonomy in HPS-dependent adults with chronic IF, with data assembled from 57 studies. The included studies were from fifteen different countries as well as international collaborations across Europe and worldwide. Patients were followed up from as early as 1969 [31], with most studies following the patient cohorts up over a few decades. Uniquely in this patient group, we present the data in a meta-analysis, providing rates for the two most important clinical outcomes in chronic IF. These findings, together with a thorough overview of risk factors identified by the included studies, increase our understanding of this complex condition and provide useful baseline data for clinical decision-making and patient counselling.
+
+Our meta-analysis shows that the overall mortality of patients with chronic IF was 8.0% per year of follow-up (95% CI 6.0 to 10.0%), or 33.5% over a mean of 49.02 months of follow-up. Notably, studies of patients with chronic IF due to Crohn’s disease [33,64,66,74] had substantially lower mortality rates in comparison to studies with mixed populations [6,18,19,25,32,40,43,47,51,54,58,67,71,72]; these are important data for patients living with inflammatory bowel disease, as well as for their treating clinicians, who can often fear HPS-dependency as representing an end-stage process of their disease [66]. The summary of survival curves estimated the pooled five- and ten-year survival rates from HPS initiation as 68.71% and 52.46%, respectively, with a more pronounced decline in survival during the initial five years of follow-up in comparison to the following years. Studies from Europe and North America had similar mortality rates over time [9,18,20,22,38,54,55,62,68], in contrast to the study conducted in Brazil [56], with a substantially higher mortality rate, which was suggested by the study authors to be due to the low socio-economic income and low literacy rates of patients, which made HPS management challenging, reiterating the need for tailored and focussed education for patients living with this condition [81]. Moreover, while in our pooled results only 12.2% of patient deaths were deemed to be IF-related, with non-IF/non-HPS-related causes reported as the primary reason in 45.6% of patients, it is noteworthy that over 5% of all deaths were related to catheter-related bloodstream infections, highlighting the need for sustained educational approaches in aseptic technique and promotion of the use of novel anti-microbial locks to mitigate this complication [81].
+
+Out of the studies included in the survival curve summary analysis, three followed patients until HPS weaning [43,62,68], with the rest following patients until death or the end of the study period [18,20,22,38,54,55,56]. The type of follow-up is important, as the former method violates the independent censoring assumption, since such a model is a competing risk model. This can lead to an underestimation of the true survival rate due the fact that the least frail patients are more likely to wean off HPS and, hence, are censored by the Kaplan–Meier method in the survival function. In order to adjust for that, Fuglsang et al., in their landmark paper, suggested performing analysis with the Aalen–Johansen estimator—a method appropriate for estimating cumulative incidence in case of competing risks in cohorts followed up until HPS cessation—and ensuring that the results are interpreted as “cumulative mortality before attempted weaning off” [22] when making comparisons between studies.
+
+Moreover, our meta-analysis showed that nutritional autonomy was achieved in 35.3% of patients, at a rate of 10.0% per year of follow-up (95% CI 7.0% to 14.0%). Studies on patients with chronic IF due to SBS [22,31,38,55,65,68] had a substantially lower rate of regaining nutritional autonomy in comparison to studies with mixed populations [6,18,25,32,40,43,47,51,54,58,67,71,72], likely because of surgical or medical interventions available for other chronic IF disease mechanisms—such as surgical intervention for fistula repair or alleviation of obstruction—that facilitate HPS weaning. Overall, only three studies [22,72,77] used death as a competing risk in the analysis of the nutritional autonomy rate and constructed cumulative incidences curves using the Aalen–Johansen estimator, with the rest of the studies providing results based on Kaplan–Meier estimates. The problem with the latter method is that the obtained estimates should in fact be interpreted as the “probability of HPS dependence in immortal patients” because deaths are censored [22]. It clearly only makes sense to investigate HPS cessation before death; thus, the competing risk analysis provides less biased results and should be implemented in the analysis whenever possible.
+
+In regards to both mortality and nutritional autonomy, the meta-regression of associations was not possible due to the limited number of studies investigating potential risk factors using the same definitions and methodology. However, in summary, age, gastrointestinal anatomy, and pathological conditions leading to IF were identified by multiple studies as potential factors associated with overall mortality and nutritional autonomy. Long-term HPS dependence has also been reported to be associated with increased mortality; however, it is important to assess such analysis for an immortal time bias, where HPS-independent patients cannot die before they become independent, and so it is vital to use this variable as a time-varying covariate in the analysis. Overall, these results emphasise the inconsistency in the reported risk factors associated with clinical outcomes among chronic IF outcome studies and highlight the need for standard outcome reporting measures in research that can then be used to develop validated clinical prediction models for patients with different disease aetiologies leading to chronic IF.
+
+The findings of this study have significant implications for routine clinical practice, as well as for future chronic IF service developments. Extracting and synthesising global data on long-term outcomes of HPS-dependent patients with chronic IF has emphasised the burden of this disorder and, thus, has implications for health services worldwide. We have shown that long-term outcomes in this patient cohort can be good. This might encourage policymakers to invest resources to establish appropriate services in countries in currently unable to provide HPS [82].
+
+Furthermore, monitoring of outcomes is essential to achieve clinical and patient-centred improvement, which is why it has been recommended as a quality-of-care standard in the management of patients with chronic IF by the European Society of Clinical Nutrition and Metabolism (ESPEN) in their recent position paper [8]. Indeed, healthcare professionals providing care to patients with chronic IF could be encouraged to set tangible outcome targets that are specific to patient needs based on a review of their current practice and collection of baseline data, whether within an individual centre, across a wider region, or via a national or international network of chronic IF centres, using the same methodology for patient classification and reporting. This meta-analysis, with sub-analysis of pathological conditions leading to IF, could therefore enable centres to benchmark their patient outcomes. On a patient level, better prediction of patient survival and/or nutritional autonomy rates could lead to more informed decision-making on continuation with HPS vs. implementing alternative treatments such as glucagon-like peptide 2 analogues, autologous gastrointestinal reconstruction, or small bowel transplant (for example, early proactive selection of patients with a shorter remnant small bowel or SBS-group 1 for such interventions). Additionally, better prediction of the likelihood of nutritional autonomy could help with stratification of patients in whom more caution is required in the assessment and mitigation of further complications associated with HPS, such as catheter-related bloodstream infection, central venous catheter thrombosis, or IF-associated liver disease. Equally, better patient prognostication could also be helpful during patient consultations to manage their expectations and address concerns.
+
+This study has several strengths. We used a broad search strategy in order to maximise the likelihood of identifying all pertinent literature. The assessment of study eligibility was carried out by two investigators independently, with discrepancies resolved by consensus with a third investigator. Moreover, we included studies carried out in cohort or cross-sectional studies and excluded studies reporting outcomes in clinical trials; thus, the presented data should be generalisable to patients from both specialist as well as less established chronic IF centres. However, this meta-analysis was limited by the fact that, as a cohort meta-analysis, it was not possible to follow individuals through their disease course. If individual patient-level data had been available, this would have allowed a more detailed analysis of patients’ disease course by specific characteristics such as age, sex, pathological condition leading to chronic IF, or year of HPS initiation. Indeed, trends in improvements in clinical outcomes over time could not be assessed, as most studies provided outcomes for patients over a few decades, with the longest study following patients up for 45 years [22]. Moreover, there was significant heterogeneity between studies in our analyses. Due to the lack of detailed patient data preventing extensive subgroup analyses, the reasons for the heterogeneity are therefore speculative and may include differences between study populations including patient demographics and clinical characteristics, as well as access to novel treatments and quality of standard of care received by the patients. Indeed, subgroup analyses based on patient pathophysiological condition showed differences in the pooled overall mortality and nutritional autonomy. Furthermore, a risk of cohort meta-analyses is the potential for double-counting of individual patients by their inclusion in more than one study; however, we attempted to limit this by excluding data from overlapping cohorts at each centre. The risk-of-bias analysis raised concerns over the assessment of confounders and reporting of missing data, which are frequent issues with retrospective studies. In order to reduce this bias, future studies should strive to carry out prospective data collection with a protocol developed a priori, ideally in a multicentre setting or an international patient registry.
+
+5. Conclusions
+
+In conclusion, this study presents the first systematic review and meta-analysis on survival and the ability to regain nutritional autonomy in adults with chronic IF, which has generated rates for clinical outcomes. These findings increase our understanding of this condition, provide useful baseline data for clinical decision-making and patient counselling, and provide a list of candidate predictors for clinical prediction model development. From a methodological perspective, this study highlights the importance of using a survival and nutritional autonomy estimation methodology that results in reduced bias, such as by following patients until death or the end of the study period for survival analysis, and using death as a competing risk when analysing nutritional autonomy in HPS-dependent individuals.
+
+Supplementary Materials
+
+The following supporting information can be downloaded at https://www.mdpi.com/article/10.3390/nu18132123/s1, Supplementary Table S1. The PRISMA 2020 checklist; Supplementary Table S2. Pooled estimates of the survival probabilities from 10 studies included in the meta-analysis for patients with benign intestinal failure on home parenteral support; Supplementary Figure S1. Search strategies for all databases; Supplementary Figure S2. The time period for the included studies in years from 1969 to 2023; Supplementary Figure S3. Sub-group analysis of the overall mortality; Supplementary Figure S4. Previously reported associations of all-cause mortality from studies included in the systematic review; Supplementary Figure S5. Sub-group analysis of the regaining nutritional autonomy; Supplementary Figure S6. Previously reported associations of regaining nutritional autonomy from studies included in the systematic review. Supplementary Figure S7. Risk-of-bias chart for studies included in the systematic review.
+
+Author Contributions
+
+Conceptualisation, M.E., S.B., E.M. and S.L.; methodology, M.E., S.B. and S.L.; validation, S.B., S.L., G.L.C. and L.P.; formal analysis, M.E.; investigation, M.E., S.B. and E.M.; data curation, S.L. and L.P.; writing—original draft preparation, M.E., S.B. and S.L.; writing—review and editing, all authors; visualisation, M.E.; supervision, S.B., S.L. and G.L.C.; project administration, M.E. All authors have read and agreed to the published version of the manuscript.
+
+Institutional Review Board Statement
+
+Not applicable.
+
+Informed Consent Statement
+
+Not applicable.
+
+Data Availability Statement
+
+The original contributions presented in this study are included in the article/Supplementary Materials. Further inquiries can be directed to the corresponding author.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Abbreviations
+
+The following abbreviations are used in this manuscript: IF	Intestinal failure	
+HPS	Home parenteral support	
+CIPO	Chronic intestinal pseudo-obstruction	
+SBS	Short bowel syndrome	
+
+Figure 1 PRISMA 2020 flow diagram for a systematic review of the outcomes in patients with chronic intestinal failure receiving home parenteral support.
+
+Figure 2 Incidence rates of death per year reported by included studies, shown by pathological condition and in ascending order by year of publication. The horizontal lines represent confidence intervals, with arrows indicating extensions of the intervals. Boxes represent estimated mortality rates, with the sizes of the boxes indicating the inverse variance weight of the respective studies. Diamonds represent the pooled mortality rate. The width of the diamonds represents the width of the 95% confidence interval of the pooled mortality rate [6,18,19,20,22,25,29,31,32,33,38,40,43,47,51,54,55,58,64,65,66,67,68,69,71,72,74].
+
+Figure 3 Curves of the overall survival for patients with benign intestinal failure on home parenteral support in the 10 studies included in the meta-analysis. Notes: The grey lines represent the survival in each study, and the grey square the end of the follow-up. Each of the survival curves is labelled with the first author’s name and year of publication. The thick red line represents the summarised survival curves, with the 95% confidence bands (dashed lines) obtained with random effects [18,20,22,38,43,54,55,56,62,68].
+
+Figure 4 Incidence rates of regaining nutritional autonomy reported by included studies, shown by pathological condition in ascending order of publication. The horizontal lines represent confidence intervals, with arrows indicating extensions of the intervals. Boxes represent estimated autonomy rates, with the sizes of the boxes indicating the inverse variance weight of the respective studies. Diamonds represent the pooled autonomy rate. The width of the diamonds represents the width of the 95% confidence interval of the pooled autonomy rate [6,18,20,22,25,29,31,32,33,38,40,43,47,51,54,55,58,65,67,68,71,72].
+
+nutrients-18-02123-t001_Table 1 Table 1 Study and participant characteristics of included studies on adult patients with benign chronic intestinal failure receiving home parenteral support.
+
+Name of Author, Year of Publication	Centre	Country	Study Years from -> to	Inclusion Criteria	Exclusion Criteria	Study Design	Single/
+Multicentre	Sample Size	Mean Age (Years)	Proportion of Male Patients	Follow-Up	Median HPS Duration	Range of HPS Duration	
+Dudrick 1979 [25]	Hermann Hospital	USA		Patients with CIF	NA	Retrospective cohort study	Single	25			4530 person-days			
+Fletcher 1986 [32]	Westmead Hospital	Australia	1979 -> 1986	Patients with CIF	NA	Retrospective cohort study	Single	13	42.4		9.1 person-years	255 days	14–608 days	
+Messing 1989 [28]	Multicentre	Europe	1974 -> 1985	Patients with CIF	NA	Retrospective cohort study	Multi	194	44	52.1%				
+Ng 1989 [29]	UCLA Hospital	USA	1979 -> 1987	Patients with CIF due to scleroderma/CREST	NA	Retrospective cohort study	Single	15		6.7%	15,700 person-days	2.9 years	2 months–7.5 years	
+Galandiuk 1990 [33]	Cleveland Clinic	USA	1976 -> 1987	Patients with CIF due to Crohn’s disease	NA	Retrospective cohort study	Single	41	39	39.0%	121 person-years	1083 days	33–3258 days	
+Howard 1991 [26]	OASIS Registry	USA	1984 -> 1987	Patients with CIF	NA	Retrospective cohort study	Multi	1594						
+O’hanrahan 1992 [34]	Multicentre	UK	1977 -> 1991	Patients with CIF	NA	Retrospective cohort study	Multi	400		52.5%		11.2 months	1–77 months	
+Johnston 1993 [27]	Ninewells Hospital and Medical School	UK	1980 -> 1992	Patients with CIF	NA	Prospective cohort study	Single	30		56.7%	17,327 person-days			
+Takagi 1995 [35]	Multicentre	Japan	1990	Patients with CIF	NA	Retrospective cross-sectional study	Multi	231	46	60.6%		683 days		
+Shields 1996 [30]	University Hospital Queen’s Medical Centre	UK	1983 -> 1993	Patients with CIF	NA	Retrospective cohort study	Single	162			4997 person-days			
+Van Gossum 1996 [36]	Multicentre	Europe	1993 -> 1994	Patients with CIF	NA	Retrospective cohort study	Multi	496		11.5%				
+Jeppesen 1998 [37]	Multicentre	Denmark	1991 -> 1995	Patients with CIF	NA	Retrospective cohort study	Multi	129		36.4%	313.5 person-years			
+Messing 1999 [38]	Hopital Lariboisiere-St. Lazare/Hopital La Miletrie	France	1980 -> 1992	Patients with CIF due to SBS	Severe visceral failure at the time of short bowel occurrence; or patients with evolving primary malignancy either present at the time of short bowel occurrence or recurring during follow-up; or patients who had received other treatments than HPN for intestinal failure, e.g., growth hormone or reconstructive surgery of the remnant bowel, such as surgically reversed small bowel loop or small bowel transplantation	Retrospective cohort study	Multi	124	52	50.0%				
+Reimund 1999 [39]	Hopitaux Universitaires de Strasbourg	France	1994 -> 1997	Patients with CIF	NA	Retrospective cohort study	Single	27	55.7	70.4%				
+Scolapio 1999 [40]	Mayo Clinic	USA	1975 -> 1995	Patients with CIF	NA	Retrospective cohort study	Single	225	51	46.2%				
+Van Gossum 1999 [41]	Multicentre	Europe	1997 -> 1998	Patients with CIF	NA	Retrospective cohort study	Multi	494		41.1%				
+Wasa 1999 [31]	Osaka University Hospital	Japan	1969 -> 1999	Patients with CIF due to SBS	NA	Retrospective cohort study	Single	18		44.4%				
+Cavicchi 2000 [24]	Hopital Lariboisiere-St. Lazare/Hopital La Miletrie	France	1985 -> 1996	Patients with CIF	Malignancy, AIDS	Prospective cohort study	Multi	90	45	55.6%		45 months	6–198 months	
+Thompson 2000 [42]	Omaha Veterans Administration Medical Center and University of Nebraska Medical Center	USA	1980 -> 1999	Patients with CIF due to SBS	NA	Retrospective cohort study	Single	106						
+Pironi 2003 [43]	Chronic Intestinal Failure Centre of Bologna University	Italy	1986 -> 2001	Patients with CIF	Malignancy, AIDS	Retrospective cohort study	Single	40	42.6	45.0%	146 person-years	3.74 years	0.08–11.02 years	
+Freshwater 2005 [44]	Russells Hall Hospital	UK	1989 -> 2002	Patients with CIF	NA	Retrospective cohort study	Single	23	50	43.5%	16,173 person-days			
+Moreno-Villares 2006 [45]	Multicentre	Spain	1992 -> 2003	Patients with CIF	NA	Retrospective cohort study	Multi	86	51	38.4%				
+Ugur 2006 [46]	Multicentre	Denmark	1996 -> 2001	Patients with CIF	NA	Retrospective cohort study	Multi	202	54	43.1%		5.1 years	30 days–32 years	
+Bonifacio 2007 [47]	Naples/Rotondo	Italy	1995 -> 2005	Patients with CIF	HPN < 6 months, oncology patients	Retrospective cohort study	Multi	41	52	48.8%	35,449 person-days	630 days	77–2705 days	
+Marra 2007 [48]	The Virginia Commonwealth University Medical Center	USA	1981 -> 2005	Patients with CIF	HPN < 6 months	Retrospective cohort study	Single	47	44.8	29.8%				
+Green 2008 [49]	John Radcliffe Hospital	UK	1990 -> 2004	Patients with CIF	NA	Retrospective cohort study	Single	88	40	45.5%	121 person-years	217.8 days		
+Amiot 2009 [20]	Hopital Lariboisiere-St. Lazare/Beaujon Hospital	France	1980 -> 2006	Patients with CIF due to CIPO	Exclusion criteria were (a) chronic organic intestinal obstruction, such as peritoneal carcinosis, radiation enteritis, and Crohn’s disease; and (b) CIPO patients without HPN requirement	Retrospective cohort study	Multi	51	20	35.3%				
+Putchakayala 2009 [50]	Northwestern Memorial Hospital	USA	1999 -> 2006	Patients with CIF	NA	Retrospective cohort study	Single	133	50.7	36.8%				
+Vafa 2010 [51]	Hopital Erasme, Universit? Libre de Bruxelles	Belgium	1987 -> 2007	Patients with CIF	NA	Retrospective cohort study	Single	65	52	46.2%	74,760 person-days		1–240 months	
+Elriz 2011 [52]	Multicentre	France	1986 -> 2004	Patients with CIF due to Crohn’s disease	HPN < 12 months	Retrospective cohort study	Multi	38		52.6%				
+Guglielmi 2012 [53]	Gastroenterology Unit of the University of Bari/Gastroenterology Unit of San Pellegrino Hospital	Italy	1984 -> 2009	Patients with CIF	NA	Retrospective cohort study	Multi	131				830 days		
+Hallum 2012 [54]	Scottish HPN Managed Clinical Network	UK	2000 -> 2007	Patients with CIF	NA	Prospective cohort study	Multi	136	47	33.8%	271 person-years	2 years	1 month–8 years	
+Amiot 2013 [55]	Beaujon Hospital	France	1980 -> 2006	Patients with CIF due to SBS	HPN < 3 months, malignancy	Retrospective cohort study	Single	268	52.5	48.1%				
+Lee 2014 [56]	Department of Gastroenterology University of Sao Paulo	Brazil	1991 -> 2013	Patients with CIF	NA	Retrospective cohort study	Single	128		60.2%				
+Watanabe 2014 [57]	Multicentre	Japan	1970 -> 2009	Patients with CIF due to Crohn’s disease	NA	Retrospective cohort study	Multi	101	38.2					
+Barco 2016 [58]	Academic Medical Center Amsterdam	Netherlands	1986 -> 2014	Patients with CIF	HPN < 3 months, peripheral catheters, incomplete medical data	Retrospective cohort study	Single	236	54	39.8%	684.1 person-years	17 months		
+Brandt 2017 [6]	Rigshospitalet	Denmark	1970 -> 2010	Patients with CIF	NA	Retrospective cohort study	Single	508	53.9	41.7%	1750.7 person-years	519 days	2–12,414 days	
+Lorentsen 2017 [59]	Zealand University Hospital	Denmark	2005 -> 2014	Patients with CIF due to SBS	NA	Retrospective cohort study	Single	78	64			860 days		
+Van Gossum 2017 [60]	Multicentre	Europe	2008 -> 2014	Patients with CIF due to post-bariatric complications	NA	Retrospective cohort study	Multi	77	50	15.6%				
+Wu 2017 [61]	Department of General Surgery Zhongshan Hospital of Fudan University	China	1985 -> 2015	Patients with CIF due to SBS	HPN < 2 years, malignancy	Retrospective cohort study	Single	47	45.1	44.7%		8.13 years		
+Joly 2018 [62]	Multicentre	Europe/USA	2000 -> 2004	Patients with CIF	Malignancy, AIDS	Retrospective cohort study	Multi	472	51	42.2%				
+Koelfat 2019 [63]	Department of Gastroenterology of Radboud University Medical Center	Netherlands	2007 -> 2017	Patients with CIF	HPN < 3 months, no clinical data and blood samples; patients with obstructive cholestasis caused by biliary malignancies or autoimmune diseases [e.g., primary sclerosing cholangitis]	Prospective cohort study	Single	135	50.3	25.9%		46 months	14–83 months	
+Bakhshi 2020 [64]	Olmsted Medical Center	USA	1992 -> 2018	Patients with CIF due to Crohn’s disease	NA	Retrospective cohort study	Single	14		14.3%		2.4 years	40 days–16.4 years	
+Cruz 2020 [65]	University of Pittsburgh Medical Center	USA	2013 -> 2018	Patients with CIF due to SBS	SB > 50 cm	Retrospective cohort study	Single	45	46.7	42.2%				
+Fuglsang 2020 [22]	Rigshospitalet	Denmark	1970 -> 2015	Patients with CIF due to SBS	IF due to another mechanism, SB > 200	Retrospective cohort study	Single	331	54.9		2429 person-years	1.65 years		
+Pironi 2020 [9]	Multicentre	Worldwide	2015 -> 2016	Patients with CIF	Malignancy	Retrospective cohort study	Multi	2194	51.1	37.0%				
+Watanabe 2020 [66]	Osaka University Hospital	Japan	2000 -> 2019	Patients with CIF due to Crohn’s disease	NA	Retrospective cohort study	Single	21	39	61.9%				
+McKee 2021 [67]	Greater Glasgow and Clyde Health Board	UK	1993 -> 2018	Patients with CIF	NA	Retrospective cohort study	Multi	205	56	38.0%	209,864 person-days			
+Noelting 2021 [68]	Canadian HPN Registry	Canada	1972 -> 2017	Patients with CIF due to SBS	NA	Prospective cohort study	Multi	321		34.9%	2287 person-years	4.2 years		
+Oke 2021 [19]	St Mark’s Hospital	UK	1979 -> 2016	Patients with CIF	Patients with short-term IF	Retrospective cohort study	Single	978	52.4	42.0%	3993 person-years			
+Gondolesi 2022 [69]	Multicentre	Argentina	2017 -> 2020	Patients with CIF due to SBS	Incomplete written consent	Prospective cohort study	Multi	56	50	48.2%		33.5 months		
+Kopczynska 2022 [18]	Salford Royal Hospital	UK	1978 -> 2018	Patients with CIF	NA	Retrospective cohort study	Single	1046	53	40.2%	7344.1 person-years	2.8 years	0.02–37.9 years	
+Thompson 2022 [70]	University of Nebraska Medical Center	USA	1990 -> 2019	Patients with CIF due to SBS	Follow-up < 12 months, patients with cholecystectomy after developing SBS	Retrospective cohort study	Single	485						
+Brito 2023 [71]	Hospital Garcia de Orta	Portugal	2011 -> 2021	Patients with CIF	NA	Retrospective cohort study	Single	13	63.46	46.2%		23 months		
+D’Eusebio 2023 [72]	Citta della Salute e della Scienza Hospital of Torino	Italy	1985 -> 2016	Patients with CIF	HPN < 3 months, active neoplastic disease and/or being under anti-neoplastic treatment within the previous 5 y, inability to give informed consent, and critically ill patients with a <6-month life expectancy	Retrospective cohort study	Single	324	57.2	45.4%	1524 person-years	2.8 years		
+Santos 2024 [73]	Centro Hospitalar Universitario de Santo Antonio	Portugal	1994 -> 2023	Patients with CIF due to SBS	Type 2 IF, death prior to discharge on HPN	Retrospective cohort study	Single	13	44	38.5%				
+Siddiqui 2024 [74]	Cleveland Clinic HPN Registry	USA	2013 -> 2019	Patients with CIF due to IBD	NA	Retrospective cohort study	Single	407	45.7	46.4%	208,767 person-days			
+Notes: Blank cells correspond to data not being provided in studies. CIF, chronic intestinal failure; CIPO, chronic intestinal pseudo-obstruction; IBD, inflammatory bowel disease; HPS, home parenteral support; SBS, short bowel syndrome.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
+References
+
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+57. Watanabe K. Sasaki I. Fukushima K. Futami K. Ikeuchi H. Sugita A. Nezu R. Mizushima T. Kameoka S. Kusunoki M. Long-term incidence and characteristics of intestinal failure in Crohn’s disease: A multicenter study J. Gastroenterol. 2014 49 231 238 23564229 10.1007/s00535-013-0797-y
+58. Barco S. Heuschen C.B.B.C.M. Salman B. Brekelmans M.P.A. Serlie M.J. Middeldorp S. Coppens M. Home parenteral nutrition-associated thromboembolic and bleeding events: Results of a cohort study of 236 individuals J. Thromb. Haemost. 2016 14 1364 1373 27122107 10.1111/jth.13351
+59. Lorentsen R. Munck L.K. Wildt S. Parenteral therapy and complications in patients with intestinal failure in a regional unit Scand. J. Gastroenterol. 2017 52 1326 1330 10.1080/00365521.2017.1380840 28936879
+60. Van Gossum A. Pironi L. Chambrier C. Dreesen M. Brandt C. Santarpia L. Joly F. Home parenteral nutrition (HPN) in patients with post-bariatric surgery complications Clin. Nutr. 2017 36 1345 1348 10.1016/j.clnu.2016.08.025 27642058
+61. Wu G. Jiang Y. Zhu X. Jin D. Han Y. Han J. Wu Z. Wu Z. Prevalence and risk factors for complications in adult patients with short bowel syndrome receiving long-term home parenteral nutrition Asia Pac. J. Clin. Nutr. 2017 26 591 597 10.6133/apjcn.082016.08 28582806
+62. Joly F. Baxter J. Staun M. Kelly D. Hwa Y. Corcos O. De Francesco A. Agostini F. Klek S. Santarpia L. Five-year survival and causes of death in patients on home parenteral nutrition for severe chronic and benign intestinal failure Clin. Nutr. 2018 37 1415 1422 10.1016/j.clnu.2017.06.016 28701261
+63. Koelfat K.V.K. Huijbers A. Schaap F.G. van Kuijk S.M.J. Lenicek M. Soeters M.R. Wanten G.J.A. Olde Damink S.W.M. Low circulating concentrations of citrulline and FGF19 predict chronic cholestasis and poor survival in adult patients with chronic intestinal failure: Development of a Model for End-Stage Intestinal Failure (MESIF risk score) Am. J. Clin. Nutr. 2019 109 1620 1629 10.1093/ajcn/nqz036 31075790
+64. Bakhshi Z. Yadav S. Salonen B.R. Bonnes S.L. Varayil J.E. Harmsen W.S. Hurt R.T. Tremaine W.J. Loftus E.V.J. Incidence and Outcomes of Home Parenteral Nutrition in Patients With Crohn Disease in Olmsted County, Minnesota Crohn’s Colitis 360 2020 2 otaa083 10.1093/crocol/otaa083 34142084 PMC8202468
+65. Cruz R. McGurgan J. Butera L. Poloyac K. Roberts M. Stein W. Minervini M. Jorgensen D. Humar A. Gastrointestinal Tract Reconstruction in Adults with Ultra-Short Bowel Syndrome: Surgical and Nutritional Outcomes Surgery 2020 168 297 304 10.1016/j.surg.2019.12.001 32139142
+66. Watanabe Y. Mizushima T. Fujino S. Ogino T. Miyoshi N. Takahashi H. Uemura M. Matsuda C. Yamamoto H. Doki Y. Long-term outcome of patients with Crohn’s disease on home parenteral nutrition Nutrition 2020 78 110903 32736298 10.1016/j.nut.2020.110903
+67. McKee R.F. Knight K. Leitch E.F. Stevens P. Changes in adult home parenteral nutrition practice over 25 years Clin. Nutr. ESPEN 2021 45 170 176 10.1016/j.clnesp.2021.08.034 34620313
+68. Noelting J. Gramlich L. Whittaker S. Armstrong D. Marliss E. Jurewitsch B. Raman M. Duerksen D.R. Stevenson D. Lou W. Survival of Patients with Short-Bowel Syndrome on Home Parenteral Nutrition: A Prospective Cohort Study J. Parenter. Enter. Nutr. 2021 45 1083 1088 10.1002/jpen.1984 32740954
+69. Gondolesi G.E. Ortega M.L. Doeyo M. Buncuga M. Perez C. Maurino E. Costa F. De Barrio S. Manzur A. Donnadio L. First registry of adult patients with chronic intestinal failure due to short bowel syndrome in Argentina: The RESTORE project J. Parenter. Enter. Nutr. 2022 46 1623 1631 10.1002/jpen.2387 35511709
+70. Thompson J.S. Rochling F.A. Lyden E. Merani S. Vargas L.M. Grant W.J. Langnas A.N. Mercer D.F. Cholecystectomy prior to short bowel syndrome does not alter nutritional prognosis Am. J. Surg. 2022 224 1285 1288 10.1016/j.amjsurg.2022.06.015 35787911
+71. Brito M. Padinha M. Carlos S. Oliveira C. Santos A.P. Nunes G. Santos C.A. Fonseca J. Long-Term Intestinal Failure and Home Parenteral Support: A Single Center Experience GE Port. J. Gastroenterol. 2023 30 127 133 37008517 10.1159/000522161 PMC10050871
+72. D’Eusebio C. Merlo F.D. Ossola M. Bioletto F. Ippolito M. Locatelli M. De Francesco A. Anro M. Romagnoli R. Strignano P. Mortality and parenteral nutrition weaning in patients with chronic intestinal failure on home parenteral nutrition: A 30-year retrospective cohort study Nutrition 2023 107 111915 36566610 10.1016/j.nut.2022.111915
+73. Santos M.D. Magalhaes V. Loureiro L. Pina P. Castro A. Aguiar P. Rocha A. Management of Short Bowel Syndrome With Chronic Intestinal Failure: A Single-Center Experience in Portugal Cureus 2024 16 e63443 10.7759/cureus.63443 39077232 PMC11284821
+74. Siddiqui M. Coughlin K. Koenen B. Al-Yaman W. Bestgen A. Regueiro M. Kirby D. Association between tunneled catheter placement and catheter-associated deep venous thrombosis in adults with inflammatory bowel disease receiving home parenteral nutrition: A retrospective cohort study J. Parenter. Enter. Nutr. 2024 48 562 570 10.1002/jpen.2647 38949827
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+81. Pironi L. Boeykens K. Bozzetti F. Joly F. Klek S. Lal S. Lichota M. Mühlebach S. Van Gossum A. Wanten G. ESPEN practical guideline: Home parenteral nutrition Clin. Nutr. 2023 42 411 430 10.1016/j.clnu.2022.12.003 36796121
+82. Fuglsang K.A. Brandt C.F. Jeppesen P.B. Survival in patients initiating home parenteral support due to nonmalignant short bowel syndrome compared with background population Clin. Nutr. ESPEN 2022 50 170 177 10.1016/j.clnesp.2022.05.023 35871920
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Cancer Med
+Journal ID: Cancer Med
+NLM Journal ID: 101595310
+Journal ID: CAM4
+
+Cancer Medicine
+
+EISSN: 2045-7634
+Publisher: Wiley
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12427358
+PMID: 40938280
+DOI: 10.1002/cam4.71214
+Article ID: CAM471214
+Article ID: CAM4-2024-06-3456.R2
+Article version: 1
+Subjects: Review, Review
+
+Barriers & Facilitators to Help‐Seeking Behaviour for Abnormal Lower Urinary Tract Symptoms in Men: Systematic Review
+
+McIntosh Stephen https://orcid.org/0009-0009-1611-6386 1 sm01966@surrey.ac.uk
+
+Harries Bethany 1
+Perry Matthew https://orcid.org/0000-0002-5980-0366 1
+Cropley Mark 1
+Dibb Bridget 1
+1 School of Psychology Faculty of Health and Medical Science, University of Surrey Guildford UK
+* Correspondence:
+Stephen McIntosh (sm01966@surrey.ac.uk)
+
+Electronic publication date: 2025 Sep 12
+Publication date: 2025 Sep
+Volume: 14
+Issue: 18
+Electronic Location ID: e71214
+Revised 2025 Jul 23; Received 2024 Nov 28; Accepted 2025 Aug 26
+Copyright: © 2025 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.
+License: This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: abnormal LUTS, bothersome LUTS, colorectal cancer, help‐seeking, prostate cancer, psycho‐oncology, testicular cancer
+Figure count: 1
+Table count: 1
+Page count: 11
+
+source-schema-version-number: 2.0
+cover-date: September 2025
+details-of-publishers-convertor: Converter:WILEY_ML3GV2_TO_JATSPMC version:6.6.2 mode:remove_FC converted:12.09.2025
+
+S. McIntosh , B. Harries , M. Perry , M. Cropley , and B. Dibb , “Barriers & Facilitators to Help‐Seeking Behaviour for Abnormal Lower Urinary Tract Symptoms in Men: Systematic Review,” Cancer Medicine 14, no. 18 (2025): e71214, 10.1002/cam4.71214.
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+Background
+
+Men face numerous challenges when deciding whether to engage in help‐seeking for abnormal lower urinary tract symptoms (LUTS), with help‐seeking behaviour a multi‐step process.
+
+Objective
+
+This systematic review explores the barriers and facilitators to help‐seeking behaviour in adult men for abnormal LUTS.
+
+Methods
+
+Eight databases (PubMed, Web of Science, Cochrane Library, EBSCOhost, SCOPUS, OVID, ProQuest and PsychINFO) were searched between January 2023 and March 2024. Studies were required to meet the inclusion criteria informed by PRISMA guidelines. Qualitative and mixed‐method studies were included in the systematic review.
+
+Results
+
+(N) = 17 full‐text articles were included in the review, totalling (n) = 704 participants. The systematic review uncovered four key themes: men have poor relationships with the healthcare system, some minority groups have dysfunctional cultural beliefs and attitudes towards help‐seeking behaviour, traditional gender views and perceptions of masculinity discourage help‐seeking behaviour and men have intrapersonal and external barriers.
+
+Conclusions
+
+Men face considerable challenges when deciding to engage in help‐seeking for abnormal LUTS, with men generally lacking awareness and knowledge of what they should do when experiencing symptoms. This is more profound in men from minority groups. This review may have had a language bias as non‐English studies were excluded. This review may be essential to inform the development of interventions to facilitate help‐seeking behaviour for abnormal LUTS in men, specifically men from minority populations.
+
+1 Introduction
+
+Abnormal symptom of the lower urinary tract (LUTS), rectum and testicles are highly prevalent, as an estimated 44.7% of men experience abnormal LUTS worldwide [1], with the risk of said symptoms increasing with age [1, 2]. LUTS, rectal and testicular symptoms are often very worrisome for patients due to the possible severity of the symptoms, the difficulty in determining the cause of the problem and the negative impact on quality of life [3, 4].
+
+Abnormal LUTS are defined as symptoms that impair the function of the prostate, urethra or bladder. They are categorised into urinary incontinence, storage/overactive bladder, voiding and postmicturition [5]. Abnormal symptoms affecting the scrotum and testicle include benign masses, infections, testicular torsions and testicular cancer [6]. Abnormal symptoms of the rectum vary from benign conditions such as haemorrhoids, anal fissures and rectal prolapse to serious conditions such as colorectal cancer [7]. Patients often delay help‐seeking for abnormal LUTS, rectal and testicular symptoms, but it is unclear as to why [8].
+
+Due to the potential severity of abnormal LUTS, it is essential for men to engage in help‐seeking for abnormal symptoms [9]. Help‐seeking is a dynamic process whereby an individual acknowledges a problem and attends primary care for their problem [10]. It is important to determine the cause of the symptoms to rule out more severe problems. For example, urinary hesitancy is a symptom of both benign prostate hyperplasia (BPH) and prostate cancer (PCa; [11]), and prostate cancer is potentially life‐threatening, whereas BPH is not life‐threatening [11]. This example is one of many highlighting the importance of distinguishing the severity of abnormal LUTS, rectal or testicular symptoms. Existing literature in this area suggests that men do not readily engage in help‐seeking in primary care for abnormal LUTS, testicular and rectal symptoms [12]. Nevertheless, given the increasing number of studies in this area, a systematic review is essential to summarise and appraise the evidence from the existing literature.
+
+This systematic review aims to fill the gaps in the literature by establishing the barriers and facilitators men encounter when deciding whether to access primary care when experiencing abnormal LUTS, rectal or testicular symptoms. The objective is to build on the paucity of existing literature with evidence‐based data on help‐seeking for LUTS, rectal and testicular symptoms, which may be applied by primary care and health policy to reduce the barriers men face when deciding to engage in help‐seeking.
+
+2 Methodology
+
+2.1 Search Strategy
+
+Using PRISMA guidelines [13], Searches for papers were conducted between January 2023 and March 2024. No date restrictions were applied to the literature search. A search was carried out using the advanced search feature on several scientific databases. Searches were carried out using PubMed, Web of Science, Cochrane Library, EBSCOhost, SCOPUS, OVID, ProQuest and PsycINFO. Searches were carried out using the advanced search feature. The keywords and synonyms for the following search terms were categorised into: “Barriers & Facilitators”, “help‐seeking”, “abnormal lower urinary tract symptoms” and “male”. The search terms were connected using Boolean operators “AND” between categories and “OR” within categories. The search terms were derived from PubMed (Medical Subject Headings/MeSH), and a combination of these terms was used to produce an appropriate electronic search strategy.
+
+The PubMed search items were linked to the acronym PICOS. The field code MeSH was used for searching items that had to be the subject of an article. For free search items that could be found in either the title or abstract of an article, the code [Title/Abstract] was used.
+
+An asterisk symbol [*] was used for variation of words at once. The question mark symbol [?] was used as a wildcard to replace or denote an extra letter where spelling or word variation is possible (e.g., utili?ation). Filters were placed on the search only to include search results conducted on the human species, studies on adults, samples only consisting of men and studies using the English language. PsycINFO, Web of Science, Cochrane Library, EBSCOhost, SCOPUS, OVID and ProQuest handle different field codes for search items (see Appendix S1).
+
+2.2 Study Selection
+
+The inclusion criteria were developed using the PICOS (participants, intervention, comparator, outcome measure and study design) framework to assist with the selection of studies to be used in the review. Participants: Either diagnosed with genitourinary or colorectal cancer or men seeking help for new or persistent abnormal lower urinary tract symptoms
+
+Intervention: Qualitative studies exploring attitudes and beliefs towards help‐seeking behaviour for abnormal lower urinary tract, testicular and rectal symptoms in adult men.
+
+Comparator: Not available
+
+Outcome Measure: Attitudes, beliefs and experiences of help‐seeking that serve as barriers and facilitators related to engaging in help‐seeking behaviour (accessing primary care) for new/persistent abnormal lower urinary tract, testicular and rectal symptoms.
+
+Study Design: Qualitative studies and mixed‐method studies
+
+To be included in the review, studies are also required to meet the following inclusion criteria: The sample population must be adults over the age of 18.
+
+Participants must be born and identify as male.
+
+Either diagnosed with a form of genitourinary cancer or colorectal cancer or seeking help for abnormal lower urinary tract symptoms.
+
+Help‐seeking is defined as seeking help from primary care services such as a GP or community pharmacist.
+
+The first Author (SM) excluded research papers that featured sample populations that were not diagnosed with a form of genitourinary or colorectal cancer or were not seeking help for abnormal lower urinary tract symptoms; were not born male or identify as male; participants who were not adults, and the study was not a qualitative study. Following this, further eligibility inclusion was conducted by SM, who assessed the titles and abstracts of research papers against the inclusion criteria. Research papers in which the title and abstract met the inclusion criteria had a full‐text screening to assess eligibility further. Papers that were deemed eligible against the inclusion and exclusion criteria after the full‐text assessment had data extraction and quality assessment performed.
+
+2.3 Title and Abstract Screening
+
+The selected studies were quality assessed by the team members (SM and BH) using the revised version of the mixed‐methods appraisal tool (MMAT; [14]). The MMAT is a checklist with questions to assess the methodological quality of research using qualitative, quantitative randomised controlled trials, quantitative non‐randomised, quantitative descriptive and mixed‐method studies. As suggested by the authors of the MMAT, team members (SM and BH) independently appraised the selected studies.
+
+The MMAT was used to determine the methodological quality of the articles in the criteria in the category of the studies design. Following the guidance from the authors of the MMAT tool, studies responding as ‘No’ or ‘Can't tell’ to the screening questions would not be considered empirical research and would be excluded. For the remaining articles, five yes‐no questions appraised the methodological quality of the articles. If all five answers were ‘Yes’, the study was included in the review. Studies with at least one ‘No’ or ‘Can't tell’ were discussed by the research team to decide whether to include them in the review. Consequently, the studies included in the review were rated as good quality by the MMAT appraisal tool (see Appendix S2).
+
+For each study selected to be included in the review, team members (SM and BH) extracted data using a previously tested standardised form. Author (SM) initially extracted data using a previously tested standardised form. The second author (BH) performed the independent data extraction on 20% of the selected studies. Data collection was (a) general study information (authors, study year, country of origin, enrolment period, inclusion and exclusion criteria); (b) population details (ethnicity, sample size and age); (c) details of the study outcomes (attitudes, beliefs and knowledge) towards abnormal lower urinary tract symptoms (LUTS), PCa, testicular cancer (TCa) and colorectal cancer (CRC) testing; (d) outcomes and findings of the papers (see Appendix S3).
+
+2.4 Data Synthesis
+
+Qualitative data was analysed and integrated using narrative synthesis following the framework set out by Popay et al. [15]. (1) Data was organised and summarised across studies. (2) Key data was grouped to form a preliminary synthesis to identify patterns in the data. (3) Relationships within and across the data in the included studies were explored. (4) The robustness of the included studies was assessed in terms of their study quality and consistency.
+
+3 Evidence
+
+3.1 Description of Studies
+
+A total of 3015 studies were identified through a literature search. Among them, 2968 studies were excluded as either duplicates or not meeting the inclusion/exclusion criteria after screening. A total of 47 studies underwent full‐text screening for eligibility. After full‐text screening, a further 30 studies were excluded. Reasons for exclusion were that the papers did not report the barriers and facilitators, did not conduct analysis, the study analysed perceptions and performance of the screening methods, no full text was available and the sample population included women and healthcare professionals (see Figure 1). Subsequently, 17 studies met the inclusion criteria and underwent data extraction. See Figure S1 in the Appendix. A narrative synthesis was performed to analyse the studies included in the review.
+
+FIGURE 1 PRISMA flow diagram.
+
+The studies included in the review were a mixture of qualitative (n = 15; [16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30]) and mixed‐method studies (n = 2; [31, 32]). The sample sizes ranged between (n = 135) and (n = 9) with a total of (n = 701) participants across all 17 studies. Several studies reported participant nationality, whilst others reported participant ethnicity. The sample population of the studies consists of a diverse range of groups; (n = 4) Caucasian men, (n = 6) African American men, (n = 3) Afro‐Caribbean men, (n = 1) South East Asian men, (n = 1) Arab American men and (n = 2) West African men. Of these studies, (n = 10) were men from a minority ethnic group in the country where the study was conducted. Abnormal LUTS can comprise several diseases; hence, there is a variation in the diseases included in the studies. Of the included studies, (n = 1) explores the barriers and facilitators to help‐seeking for TCa (n = 14) explore PCa and (n = 2) explore CRC (see Table 1 for summary of papers).
+
+TABLE 1 Showing summary of findings from papers included in the review.
+
+Authors	Year	Country	Data collection method	Cancer type	Population	Main findings	
+Oliver	2007	United States	Qualitative interviews	Prostate Cancer	African American men in rural Alabama	African American men do not trust the healthcare system due to historical malpractice. African American men also lack an understanding of prostate cancer and prostate cancer screening methods	
+Conde et al.	2011	United States	Qualitative interviews	Prostate Cancer	Filipino men in Hawai’i	Filipino men lack awareness of knowledge and awareness of prostate cancer. Hold negative beliefs towards prostate cancer, are fearful of being diagnosed with prostate cancer and present in primary care at a later stage	
+Earl et al.	2022	United States	Mixed Methods	Colorectal Cancer	African American men from Atlanta	African American men lack knowledge of colorectal cancer, cultural beliefs discourage attending primary care and machoism contributes to delay. However, men want culturally sensitive awareness programmes	
+Shungu and Sterba	2021	United States	Qualitative interviews	Prostate Cancer	African American men from South Carolina	African American Men have poor relationships with the healthcare system and lack trust with HCPs. Men also lack knowledge of prostate cancer, lack access to services and are fearful of cancer diagnosis. However, men want culturally sensitive awareness programmes	
+Medina‐Perucha et al.	2017	United Kingdom	Qualitative Interviews	Prostate Cancer	Men from the United Kingdom	Perceptions of masculinity contribute to delay. Men are also fearful and embarrassed of prostate cancer screening methods. Nevertheless, previous health problems facilitate future help‐seeking behaviour	
+King‐Okoye et al.	2019	Trinidad & Tobago	Qualitative Interviews	Prostate Cancer	Men from Trinidad and Tobago	Trinidadian men have dysfunctional beliefs about prostate cancer and have taboo over the symptoms and testing methods for prostate cancer. Men also lack knowledge of prostate cancer testing and seek alternatives to medical treatment	
+Woods et al.	2004	United States	Mixed Methods	Prostate Cancer	Black men from Southern California	Black mAusen lack knowledge of prostate cancer, have poor communication with HCPs, lack trust of HCPs and perceive testing for prostate cancer as a threat to masculinity. Men want the healthcare system to re‐build trust and build a relationship with the community	
+Seymour‐Smith et al.	2016	United Kingdom	Qualitative Interviews	Prostate Cancer	Caribbean men from the United Kingdom	Cultural beliefs in the United Kingdom discourage help‐seeking behaviour. Caribbean men have negative attitudes towards testing and Caribbean men perceive that the testing methods for prostate cancer are sexual acts	
+Ocho & Green	2013	Trinidad & Tobago	Qualitative Interviews	Prostate Cancer	Men from Trinidad and Tobago	Men lack awareness of prostate cancer, have negative views towards prostate cancer testing and perceive prostate cancer testing as a threat to masculinity. Nevertheless, men will go to the doctor with “red flag” symptoms and have a preference for PSA testing	
+Alsayid et al.	2019	United States	Qualitative Interviews	Colorectal Cancer	Arab American men from San Francisco and Massachusetts	Arab American men lack trust in HCP and lack trust in modern medicine. Men also dislike screening methods for colorectal cancer and have poor access to healthcare services. Men would prefer alternative testing methods and improve their access to healthcare services	
+Ettridge et al.	2018	Australia	Qualitative Interviews	Prostate Cancer	Australian men	Australian Men have dysfunctional beliefs towards prostate cancer, hold stigma towards disease and have poor social support networks. Stronger social support networks would facilitate help‐seeking behaviour	
+Enaworu and Khutan	2016	Nigeria	Qualitative Interviews	Prostate Cancer	Nigerian men in Nigeria	Nigerian men have poor knowledge of prostate cancer, lack access to services. Men would be more likely to go to the doctor if they had stronger support networks, improved access to services and improved knowledge of prostate cancer	
+Saab et al.	2018	Ireland	Qualitative Interviews	Testicular Cancer	Men from the Republic of Ireland	Men had poor knowledge of symptoms affecting the testicles and have poor knowledge of HCPs. Men avoid going to the doctor to preserve masculinity. However, homosexual men reported being more inclined to access primary care than heterosexual men	
+Ezenwankwo et al.	2021	Nigeria	Qualitative Interviews	Prostate Cancer	Men from Nigeria	Men lack awareness of prostate cancer and have difficulties accessing health services. Nigerian culture discourages from going to the doctor for prostate cancer and shares cancer fatalism. Nigerian men reported they will go to the doctor if they have “severe” symptoms	
+Fyffe et al.	2008	United States	Qualitative Interviews	Colorectal Cancer and Prostate Cancer	African American men from New Jersey	Men have poor communication with HCPs and lack trust in the healthcare system. Men delay going to the doctor as the DRE creates embarrassment and some men cannot afford to go to the doctor. Men want targeted outreach to African American communities	
+Forrester‐Anderson	2005	United States	Qualitative Interviews	Prostate Cancer	African American men from the Baltimore Metro area	Men have poor knowledge of prostate cancer, fear testing for prostate cancer and are embarrassed by testing for prostate cancer. Cultural beliefs discourage men from going to the doctor. Men also distrust the government, healthcare system and have poor communication with HCPs. Men want targeted outreach to African American communities	
+
+Eight descriptive themes emerged as barriers and facilitators across the papers. They fall into the following groups: (1) distrust of the healthcare system; (2) re‐building relationships with the healthcare system; (3) cultural stigma and attitudes; (4) community outreach programmes; (5) external barriers; (6) presence of symptoms; (7) extraneous barriers; (8) extraneous facilitators. Four overarching themes were developed: relationships with the healthcare system, cultural beliefs and attitudes, masculine beliefs and intrapersonal and external barriers (for a summary of papers included in the paper, see the table below; for full data extraction, see the Appendix).
+
+3.2 Relationships With the Healthcare System
+
+The relationship that one holds with the healthcare system plays an important role in whether individuals decide to engage in help‐seeking behaviour for abnormal LUTS. This theme is comprised of three sub‐themes: distrust of the healthcare system, poor communication with HCPs and positive relationships with HCPs. The analysis revealed that whilst poor relationships with the healthcare system and healthcare professionals are barriers to help‐seeking, building relationships with HCPs and healing wounds between the care system facilitates improved knowledge and improved informed decision making (IDM) to engage in help‐seeking for abnormal symptoms.
+
+In eight of the seventeen studies, men reported a distrust of the medical care that they will receive when seeking help for abnormal LUTS [16, 20, 21, 22, 24, 27, 30, 31]. This barrier was most prevalent in men from minority ethnic groups. Six of the seven studies that reported distrust of the healthcare system took place in the United States [16, 21, 22, 27, 30, 31].
+
+Beliefs held by African American men contributing to the lack of trust in the healthcare system stem from historical medical malpractice towards African Americans, notably the Tuskegee Syphilis experiment [22, 27, 30]. Subsequently, due to the lack of trust, African American men report having a culture with a shared reluctance to avoid going to the doctor [21, 22, 27, 30, 31]. Moreover, there is a shared perception among African American men in the United States that they do not receive equal treatment compared to white Americans [21, 31]. Consequently, some African American men share the belief that HCPs have ulterior motives; hence, they will not be open when discussing PCa with HCPs [30].
+
+Three further studies reported a distrust of healthcare and a distrust of medicine and practitioners [16, 20, 22, 24]. Some Afro‐Caribbean and West African men lack trust in the diagnostic ability of doctors and seek alternative treatments for PCa through witch doctors and herbal medicines and remedies [20, 24]. This belief differs from that of some Arab American men who do not engage in help‐seeking for CRC as they believe that cancer is a made‐up concept by pharmaceutical companies to profit from the sale of drugs [16]. Furthermore, some men reported a preference to have consultations with senior doctors as they lack trust in the diagnostic ability and medical knowledge of junior doctors [22].
+
+Poor communication with HCPs was reported by four of the seventeen studies included in the review [16, 17, 20, 32]. Poor communication was a barrier more commonly reported by men from minority ethnic groups [16, 17, 32]. Participants reported that primary care physicians were often too busy to arrange appointments, and when an appointment was arranged, some GPs did not have enough time for their patients during the consultations [16, 17, 20]. Two studies found that GPs did not fully explain the potential risks of the PSA test, inform African American men why they should or should not be offered a PSA test, or explain why they had a DRE [21, 32]. Men reported similar experiences with CRC, as men reported that GPs did not provide enough information about CRC screening and rushed consultations [16].
+
+3.2.1 Improved Relationships With Healthcare Professionals
+
+Across the reviewed papers, it was widely reported that healthcare providers and healthcare professionals play an important role in facilitative engagement in help‐seeking for abnormal LUTS. Eight of the seventeen papers reported that healthcare professionals serve as facilitators of help‐seeking behaviour [16, 17, 20, 26, 27, 30, 32]. Participants often reported wanting to know the reasons behind particular events and processes and reported that clinicians should provide them with information to aid IDM in men across all groups for engaging in help‐seeking for abnormal LUTS [30, 32]. Men from minority groups report that healthcare providers have a duty to mend strained relationships [27, 30]. Nevertheless, men across all groups shared the belief that improved relationships with GPs and improved access to healthcare services will encourage men to engage in help‐seeking for abnormal LUTS and CRC [16, 17, 20, 27, 30].
+
+3.3 Cultural Beliefs and Attitudes
+
+Cultural beliefs and norms play a key role in determining whether an individual will engage in help‐seeking for abnormal LUTS. Stigma towards engaging in help‐seeking for abnormal LUTS is often negative and was a common theme to emerge from the reviewed papers. Eleven of the seventeen papers reported negative cultural beliefs and stigma towards engaging in help‐seeking for abnormal LUTS [16, 17, 19, 20, 21, 22, 24, 26, 27, 29, 31]. This theme is comprised of two sub‐themes: negative cultural beliefs towards help‐seeking for LUTS and community outreach programmes.
+
+3.3.1 Negative Cultural Beliefs Towards Help‐Seeking for Abnormal LUTS
+
+Negative cultural beliefs were prominent among the included papers, with eight of the included studies reporting cultural stigma towards engaging in help‐seeking for abnormal LUTS [17, 20, 21, 22, 24, 27, 31]. Afro‐Caribbean men reported that it is a cultural norm to delay engaging in help‐seeking for problems that may impact sexual function and have a preference for over‐the‐counter medication before seeking help from primary care physicians [24]. Beliefs about the causes of PCa and abnormal LUTS in West African culture deter some men from engaging in help‐seeking, as cultural norms imply that PCa is caused by witchcraft, being unfaithful to partners and having PCa will make one unfit to participate in religious rituals or ceremonies [20]. This cultural norm differs from that of African American culture, which discourages help‐seeking in primary care due to historical malpractice [27, 31].
+
+Cultural fatalistic beliefs towards cancer can create delay towards help‐seeking within some cultures. Some Filipinos and African American men delay engaging in help‐seeking for abnormal LUTS as it is a cultural norm to delay help‐seeking due to fatalistic attitudes towards cancer held by many within the culture [17, 21].
+
+Cultural views held against screening methods, particularly the colonoscopy and the DRE, act as barriers towards engaging in help‐seeking [22, 25, 26, 29]. Caribbean men reported that cultural views serve as barriers to help‐seeking [26, 29]. The DRE is stigmatised among some Caribbean men as the performance of the DRE is seen as a sexual act. This cultural belief is shared among some African American men who view the DRE as a sexual act [21, 22]. Nevertheless, the negative cultural views towards homosexuality held in the Caribbean make some men very reluctant to engage in help‐seeking [26, 29].
+
+3.3.2 Challenging Negative Beliefs and Stigma Towards Help‐Seeking
+
+Challenging cultural views and stigma towards help‐seeking can facilitate help‐seeking in primary care for abnormal LUTS. Nevertheless, it is important to note that methods to challenge views and stigma are culture‐specific. Afro‐Caribbean men from two papers reported that the presence of community outreach programmes targeted specifically for the Afro‐Caribbean community would reduce stigma towards screening methods, leading to an uptake of PCa screening [24, 29]. Re‐building trust through community outreach and improved relationships with clinicians will challenge the culture of distrust of the medical system in the United States held by many African American men [21, 22, 27]. Filipino men report that similar action can be taken to dispel negative cultural attitudes towards help‐seeking through improving relationships with clinicians to facilitate IDM [17].
+
+3.4 Traditional Gender Views
+
+Self‐perceptions of masculinity and machoism play a key role in men's decisions to engage in help‐seeking for abnormal LUTS. The perceptions of one's masculinity are a prominent barrier to help‐seeking for abnormal LUTS across ages and cultures, with eight of the seventeen reviewed studies reporting that the preservation of masculinity is a barrier to help‐seeking [17, 22, 24, 25, 26, 27, 28, 30]. Moreover, due to the perceived trivialisation of men's health problems, men delay attending primary care when experiencing abnormal symptoms due to a fear of being labelled a hypochondriac [28]. Whilst the preservation of masculinity is a barrier to help‐seeking, the presence of “red flag” symptoms prompt men to engage in help‐seeking for abnormal LUTS [18, 24, 26, 32].
+
+3.4.1 Masculinity and Machoism
+
+Men generally believed in adherence to traditional gender expectations, such as exhibiting restricted emotional expression and a need for independence not burdening others with problems and minimising the severity of symptoms to maintain their perception of masculinity [25, 30]. Younger men exhibited stoic attitudes towards abnormal LUTS to maintain their masculinity [28]. Whereas, among older Afro‐Caribbean men, abnormal LUTS symptoms are normalised as “part of the natural ageing process” [24], resulting in older Afro‐Caribbean men typically engaging in delayed help‐seeking for abnormal LUTS due to the perception that symptoms are expected when becoming an older man [24].
+
+Screening methods for abnormal LUTS act as a barrier as men perceive screening as emasculating [16, 17, 22, 25, 26, 27]. Men delay screening for PCa due to the stigma surrounding the DRE, as men report fear of performing the procedure as it takes away one's manhood [22, 27]. Men have different views on who should perform the DRE, as Filipino men report great embarrassment in performing the DRE when a female nurse is present, whilst Afro‐Caribbean men have a preference for female nurses as they are less of a challenge to their manhood [17, 26].
+
+3.5 Presence of Symptoms
+
+Symptoms affecting perceived masculinity and “red flag” symptoms facilitate help‐seeking regardless of the negative stigma, embarrassment of screening or fear of screening [18, 24, 26, 28, 32]. Men will engage in timely help‐seeking for “red flag” symptoms such as blood in urine and urine retention as they are perceived with extreme severity [24]. Symptoms affecting sexual function facilitate timely help‐seeking due to the perceived emasculation due to the loss of manhood [19, 32]. Hence, receiving treatment for symptoms affecting sexual function is viewed as a restoration of one's manhood [32]. However, some African American men reported that they will continue to delay engaging in help‐seeking due to a fear of finding out the truth and the belief that African Americans are inferior, so there is no point attending primary care regardless of the severity of symptoms [21].
+
+3.6 Intrapersonal and External Barriers to Help‐Seeking Behaviour
+
+Men face considerable intrapersonal and external barriers to engaging in help‐seeking for abnormal LUTS. Men reported poor awareness of symptoms causing abnormal LUTS and a lack of awareness of how to access healthcare, whilst some men also reported a lack of access to healthcare services and a lack of culturally diverse material. Fourteen studies reported both intrapersonal and external barriers to help‐seeking [16, 17, 18, 19, 20, 21, 22, 23, 25, 27, 28, 30, 31, 32]. However, men from six studies reported what can be done to mitigate the external barriers to encourage help‐seeking for abnormal LUTS [16, 22, 25, 26, 27, 31].
+
+3.6.1 Intrapersonal Barriers to Help‐Seeking for Abnormal LUTS
+
+Men across all groups report an overall lack of awareness of men's health problems and what to do when experiencing symptoms affecting the lower urinary system [17, 20, 21, 27, 28, 32]. Young men lack knowledge of their genital area, lack knowledge and awareness of TCa and report that the trivialisation of men's health problems contributes to delays in engaging in help‐seeking for abnormal testicular symptoms [28]. Men lack awareness of CRC screening methods, with African American and Arab American men reporting very limited knowledge of CRC screening methods but reporting better knowledge of screening ranges [16, 31]. Similar findings were observed for PCa, as men report a lack of knowledge of PCa but also report a lack of available information about PCa and PCa screening [17, 19, 21, 27].
+
+Men delay accessing healthcare due to fear of the screening methods and fear of receiving a positive diagnosis [17, 21, 22, 25, 27, 28, 30]. Fear is consistent among age groups, with both younger and older men reporting a delay in help‐seeking due to fear of being diagnosed with a potentially serious health condition [17, 28]. However, men report being very fearful of CRC screening and PCa screening (specifically the DRE) and will delay engaging in help‐seeking to avoid the procedures [21, 22, 25, 27, 30].
+
+3.6.2 External Barriers to Help‐Seeking
+
+Access to healthcare services is a key barrier to accessing primary care, as men who do not have access to healthcare either cannot seek help from primary care or will find it extremely difficult to attend primary care [16, 17, 20]. Men with lower incomes report that they cannot afford to pay for screening or consultations, and their insurance will not cover screening; therefore, they will not access primary care services [17, 18, 21, 22, 23]. However, it is important to note that being unable to afford healthcare is a barrier in countries without universal access to healthcare, such as the United States.
+
+3.6.3 External Facilitators of Help‐Seeking
+
+Men report three approaches in which external facilitators can facilitate engagement in help‐seeking behaviour: improving access to healthcare services, improving awareness of abnormal LUTS and less invasive screening methods.
+
+Men report that improving awareness of problems affecting LUTS will facilitate help‐seeking behaviour as men will have greater awareness of the potential severity of potential problems [27, 31]. Moreover, men from minority groups report that diverse health literature will facilitate help‐seeking as men from these groups will feel represented [22, 32].
+
+Screening methods are important facilitators of help‐seeking, with men having an overall preference for less invasive screening methods [16, 22, 25, 26]. Screening methods are important facilitators of help‐seeking as Afro‐Caribbean men report a preference for PSA testing for PCa and report being more willing to engage in help‐seeking if the PSA test is the screening method of choice [25, 26]. Men have a preference for less invasive tests for CRC [16, 22]; however, some men report that financial incentives to screen will encourage some men to engage in screening for CRC [31].
+
+4 Discussion
+
+Using a narrative synthesis approach, this review aimed to explore the barriers and facilitators towards men face towards engaging in help‐seeking for abnormal LUTS. The data in the systematic review revealed a combination of factors, including a lack of awareness of abnormal LUTS, a lack of access to healthcare settings, taboos and cultural stigma over screening methods, poor relationships with HCPs and the fear of emasculation when screening. The reviewed papers consisted of men from an array of ages, cultures and countries. Men from minority groups reported greater barriers facing engagement in help‐seeking for abnormal LUTS, with some barriers more prominent across different conditions affecting LUTS, different cultures and countries. Nevertheless, men from minority groups also reported a greater amount of adjustments that can be made to facilitate their engagement in help‐seeking for abnormal LUTS.
+
+Men are generally positive about attending primary care for abnormal LUTS; however, the thought of attending the doctor and the preceding screening procedures created psychological discomfort, fear and challenged perceptions of masculinity [12, 16, 17, 22, 25, 26, 27, 28, 29]. Men disliked the DRE and colonoscopy as screening methods for PCa and CRC as these procedures are perceived as emasculating, invasive and a violation of privacy [16, 17, 22, 26, 27, 29]. Moreover, among some Afro‐Caribbean men, the DRE is likened to a sexual act; further stigmatised by the taboo of homosexuality among Caribbean culture [26, 33]. To avoid the label of being “homosexual” attached to them, some Afro‐Caribbean men report the preference of having a female physician conduct the DRE [26]. However, “red flag” symptoms facilitated help‐seeking regardless of whether men liked the screening method or wanted to retain perceptions of masculinity. Normalising “going to the doctor” and “talking about one's health” may challenge men's attitudes that going to the doctors takes away one's masculinity as men will begin to perceive going to the doctor as a “normal” behaviour.
+
+Men do not have trusting relationships with the healthcare system and healthcare professionals. Men across all groups and ages are reluctant to go to the doctor due to the shared perception that doctors do not have time for them [16, 17, 20]. However, men will attend the doctor once “red flag” symptoms are present ([12, 16, 17, 24]. The lack of trust in healthcare providers is greater among African American men due to the harrowing treatment of African Americans in recent American history [22, 27, 30, 31]. Moreover, African American men still do not report receiving equal treatment in healthcare in the United States [31]. Feelings of mistrust and reluctance to attend primary care are shared among black and Asian men in the United Kingdom for both physical and psychological symptoms [34]. Feelings of distrust are shared among ethnic minority groups, with the duty to mend these relationships landing on healthcare providers and policymakers.
+
+Healthcare systems have a duty to re‐build trust with men from ethnic minorities. The lack of trust between minority ethnic groups and healthcare systems exacerbates health inequalities as some groups will avoid accessing primary care until symptoms or illness have progressed. Much of the lack of trust that ethnic minorities have with respective healthcare systems is due to historical malpractice towards ethnic minorities and people from ethnic minorities viewing the poor treatment that people from ethnic minorities often experience. The lack of trust between ethnic minorities and healthcare systems extends beyond abnormal LUTS in men, where they are evident across healthcare. For example, in the United Kingdom, children of Afro‐Caribbean and African descent are less likely to have a full course of the MMR vaccine as parents of Afro‐Caribbean and African descent have less trust in the healthcare system [35]. Men from ethnic minorities suggested that healthcare providers should work directly with men from minority groups to understand “why” men from some groups do not trust the healthcare system and work together to re‐build trust within the community, which will filter down into re‐building trust between ethnic minorities and healthcare systems [21, 30, 31, 32, 36].
+
+Some men do not seek help for abnormal LUTS because there is a lack of awareness regarding abnormal LUTS. There is a lack of information available to the public to learn about symptoms affecting the lower urinary system [17, 20, 21, 25, 27, 28, 30, 31]. This is a significant barrier, yet men have no control over this barrier. Men cannot be expected to engage in help‐seeking for abnormal LUTS through the correct channels if they do not know what they are looking for or where they should go.
+
+4.1 Clinical Implications
+
+Healthcare providers and government policy should focus on re‐building relationships with minority groups through listening to suggestions made by the community to strengthen trust and reduce health disparities. Healthcare providers and policy makers have a duty to improve the awareness of men's health problems and de‐trivialise men's health. Improving disadvantaged men's access to healthcare services will incentivise men to access primary care for abnormal LUTS. Moreover, the implementation of universal healthcare will remove the financial barrier faced by millions of men across the world as healthcare will be free at the point of access [16, 20, 21, 22]. Moreover, strategies should be implemented to target higher risk groups so that help‐seeking for abnormal LUTS will become a “normal” behaviour.
+
+Guidance and support for healthcare providers in the form of four recommendations for inclusive interventions may help to address the problem for men from ethnic minority groups. (1) A step to increase inclusivity is to improve the health literature to show that men from ethnic minority groups are represented. Representative health literature will encourage the de‐stigmatisation of abnormal LUTS as men from all groups will see people like them seeking help from the doctor for similar problems. (2) Secondly, healthcare professionals should demonstrate cultural sensitivity by spending more time listening to patients from minority groups, making them feel part of the discussion in the consultation. Men from ethnic minorities want healthcare providers to listen to their suggestions and want community outreach programmes. (3) Healthcare providers working with the community should also tackle another belief, the negative beliefs held towards the healthcare system as members of the community will speak to healthcare professionals on a personal level, therefore challenging the perceived authoritative stature of healthcare professionals [37]. (4) A fourth recommendation is that healthcare professionals should also be aided with extra training and guidance to improve their cultural sensitivity to improve the consultation experience for patients of ethnic minority groups.
+
+4.2 Limitations of This Study
+
+This review may have had a language bias as non‐English studies were excluded. This exclusion may result in the review having a lack of cultural depth. However, both English and American English variations of spellings were used to yield more papers from searches. Another limitation of this systematic review is that some of the sample populations of the studies included in the review were relatively small. The small sample sizes question the generalisability of the papers included in the study.
+
+5 Conclusion
+
+It is evident that men face a multitude of challenges when determining whether they will engage in help‐seeking for abnormal LUTS. The key findings from this review indicate that men lack an awareness of abnormal LUTS, men from ethnic minorities are distrusting of healthcare professionals, but men across all groups fear emasculation from screening and hold stigma and negative cultural views towards screening methods. Younger men tend to adhere to traditional gender stereotypes and appear to delay help‐seeking to appear masculine and macho. Our work suggests that healthcare policy should increase awareness of men's health problems, particularly problems affecting the lower urinary tract and rectum. Healthcare providers should also work with minority groups to reduce stigmatising beliefs held towards abnormal LUTS and work to re‐build relationships with minority groups.
+
+Author Contributions
+
+Stephen McIntosh: conceptualization (lead), data curation (lead), formal analysis (lead), funding acquisition (equal), investigation (lead), methodology (lead), project administration (lead), resources (equal), software (equal), supervision (equal), validation (equal), visualization (lead), writing – original draft (lead), writing – review and editing (equal). Bethany Harries: methodology (equal), validation (equal). Matthew Perry: supervision (supporting), writing – review and editing (equal). Mark Cropley: supervision (supporting), writing – review and editing (equal). Bridget Dibb: conceptualization (supporting), data curation (supporting), funding acquisition (equal), investigation (supporting), methodology (supporting), project administration (supporting), supervision (lead), validation (supporting), writing – original draft (equal), writing – review and editing (equal).
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Supporting information
+
+Appendix S1: cam471214‐sup‐0001‐AppendixS1.docx.
+
+Data Availability Statement
+
+Data sharing is not applicable to this article as no new data were created or analyzed in this study.
+
+
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Curr Oncol
+Journal ID: Curr Oncol
+NLM Journal ID: 9502503
+Journal ID: curroncol
+
+Current Oncology
+
+ISSN: 1198-0052
+EISSN: 1718-7729
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC12384569
+PMID: 40862826
+DOI: 10.3390/curroncol32080457
+Article ID: curroncol-32-00457
+Article version: 1
+Subjects: Review
+
+A Narrative Review of the Roles of Nursing in Addressing Sexual Dysfunction in Oncology Patients
+
+https://orcid.org/0009-0006-9760-651X Alqaisi Omar 1 *
+https://orcid.org/0000-0002-8345-0140 Al-Ghabeesh Suhair 1
+https://orcid.org/0000-0001-7700-776X Tai Patricia 2
+Wong Kelvin 3
+Joseph Kurian 4
+https://orcid.org/0000-0002-2900-115X Yu Edward 5
+1 Faculty of Nursing, Al-Zaytoonah University of Jordon, Airport Street, 11118 Amman, Jordan; suhair_alghabeesh@yahoo.com
+2 Department of Radiation Oncology, University of Saskatchewan, Saskatoon, SK S7N 5A2, Canada; ptai2@yahoo.com
+3 Astellas Pharma Canada, 675 Cochrane Drive, Suite 650 West Tower, Markham, ON L3R 0B8, Canada; kelvin_wong@astellas.com
+4 Department of Radiation Oncology, University of Alberta, Cross Cancer Center, Edmonton, AB T6G 2G5, Canada; kurian.joseph@albertahealthservices.ca
+5 Department of Radiation Oncology, Western University, London, ON N6A 3K7, Canada; eyu@uwo.ca
+* Correspondence: omaralqaisi119@gmail.com; Tel.: +962-780598881
+Electronic publication date: 2025 Aug 14
+Publication date: 2025 Aug
+Volume: 32
+Issue: 8
+Electronic Location ID: 457
+Received 2025 Jul 3; Revised 2025 Aug 11; Accepted 2025 Aug 12
+Copyright: © 2025 by the authors.
+Copyright year: 2025
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: cancer, sexual care, nursing, immunotherapy, targeted therapy, sexual dysfunction, menopause, body image, erectile dysfunction, ejaculatory disorders
+
+Funding: This research received no external funding.
+
+Ÿ==============================Ÿ
+Simple Summary
+
+Sexual challenges are common yet often unaddressed issues for patients undergoing cancer treatment, significantly impacting their overall well-being and relationships. This review aimed to demonstrate how nurses can help with these sensitive concerns, what difficulties they face, and what solutions can improve care. We found that while nurses are crucial in providing support, they often lack specific training, face cultural discomfort, and are limited by hospital policies. Our findings suggest that better education for nurses, clear guidelines, and teamwork among healthcare providers are essential. By making sexual health a regular part of cancer care, we can significantly enhance the quality of life for cancer survivors and ensure a more complete approach to their recovery. This work provides valuable guidance for various healthcare professionals to support cancer patients.
+
+Abstract
+
+Sexual dysfunction affects an estimated 50–70% of cancer survivors but remains underrecognized and undertreated, impacting quality of life and emotional well-being. This narrative review involves a comprehensive search of PubMed/MEDLINE, CINAHL, Scopus, Web of Science, and ScienceDirect for English-language publications (January 2010–May 2025), using combined MeSH and free-text terms for ‘sexual health’, ‘cancer’, ‘nursing’, ‘roles of nurses’, ‘immunotherapy’, ‘targeted therapy’, ‘sexual health’, ‘sexual dysfunction’, ‘vaginal dryness’, ‘genitourinary syndrome of menopause’, ‘sexual desire’, ‘body image’, ‘erectile dysfunction’, ‘climacturia’, ‘ejaculatory disorders’, ‘dyspareunia’, and ‘oncology’. We used the IMRAD (Introduction, Methods, Results, and Discussion) approach to identify 1245 records and screen titles and abstracts. Fifty studies ultimately met the inclusion criteria (original research, reviews, and clinical guidelines on oncology nursing and sexual health). Results: All the treatments contributed to reduced libido, erectile dysfunction, dyspareunia, and body image concerns, with a prevalence of 57.5% across genders. Oncology nurses can provide sex education and counseling. Barriers (limited training, cultural stigma, and the absence of protocols) hinder effective intervention. Addressing these issues through sexual health curricula, formal referral systems, and policy reforms can enhance nursing care. Future research should assess the impact of targeted nurse education and the institutional integration of sexual health into cancer care.
+
+1. Introduction
+
+Sexuality is recognized as an essential and natural part of everyone’s life, regardless of age or physical condition [1], and is considered a central aspect of healthcare [2]. The harmful impacts of cancer and its treatments on sexuality are well known [3,4,5,6]. Patients with cancer may experience a range of sexual health challenges, including decreased libido, negative body image, vaginal dryness, genital hypoesthesia, negative body image, pain during sexual intercourse, and difficulty achieving orgasm [7,8].
+
+The prevalence of this problem is very high. For example, a recent systematic review and meta-analysis of women with cancer revealed that up to 66% experienced sexual problems, with rates ranging from 58% for colorectal cancer to 55–89% for breast and gynecological cancers [9]. Additionally, 77.5–88.7% of breast cancer patients in China experience sexual health problems [10]. Furthermore, Proctor et al. reported that 57.5% of cancer survivors reported scores indicative of sexual dysfunction, with a similar prevalence observed among both men and women [11]. The WHO recommends patient-centered sexual healthcare, which delivers proper education together with counseling and medical support to individuals [12]. There is a lack of standardized protocols for incorporating sexual health education into routine cancer care practices in many institutions [13].
+
+Sexual problems significantly affect patients’ physical and emotional well-being and quality of life and even lead to marital breakdown and suicide during the long cancer journey [14,15,16]. Sexual dysfunction is a common issue among cancer patients and has a significant effect on their overall well-being. However, research shows that it is frequently overlooked and rarely addressed in clinical settings [17,18]. Many patients do not actively seek medical support for sexual health concerns. For example, a study in mainland China revealed that although 42% of women with breast cancer recognized the value of receiving sexual health information from oncology professionals, 76% had never consulted healthcare providers about these issues [18]. Instead, they often turn to friends, peers, or online sources, which may lack reliability or effectiveness [19]. In clinical practice, healthcare professionals such as oncologists and nurses tend to prioritize treatment, rehabilitation, nutrition, and symptom management while often neglecting sexual health [20].
+
+Research into nurses’ perspectives on addressing patients’ sexual health indicates that systemic challenges within the biomedical model of care hinder adequate attention to this issue. These challenges include short appointment times, insufficient training, and unclear professional responsibilities [21]. Additionally, nurses often frame sexual health in purely functional terms, leading to insufficient screening, communication, and interventions related to sexual issues [22]. Therefore, this narrative review seeks to examine existing research on the role of nurses in recognizing, addressing, and supporting sexual dysfunction in cancer patients.
+
+2. Materials and Methods
+
+This narrative review aimed to explore the roles of nurses in addressing sexual dysfunction among oncology patients. A comprehensive literature search was conducted across five major academic databases, namely, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus, Web of Science, and ScienceDirect, spanning the period from January 2010 to May 2025.
+
+To ensure inclusivity and depth in the search strategy, Boolean operators (AND, OR) were used to combine a broad set of keywords. These included sexual health, cancer, nursing, nursing roles, immunotherapy, targeted therapy, sexual dysfunction, vaginal dryness, genitourinary syndrome of menopause, sexual desire, body image, erectile dysfunction, climacturia, ejaculatory disorders, dyspareunia, and oncology.
+
+A wide range of publication types was considered to capture diverse perspectives and insights. These included original research articles, review papers, case reports, randomized and nonrandomized controlled trials, cohort studies, cross-sectional studies, and surveys. However, the primary focus remained on original research studies that specifically addressed the role of nurses in managing sexual dysfunction in cancer patients.
+
+Explicit inclusion and exclusion criteria were applied to refine the scope of the review. Articles were included if they were published in English and if they directly discussed nursing interventions or roles related to sexual dysfunction in oncology populations. The exclusion criteria were as follows:Non-English publications;
+
+Conference abstracts and commentaries;
+
+Studies not directly addressing the core topic;
+
+Duplicate articles.
+
+The initial search yielded 1245 records. After 235 duplicates were removed, 1010 titles and abstracts were screened. On the basis of the eligibility criteria, 50 articles were ultimately selected for inclusion in the final review. Discrepancies in article selection between the two lead reviewers (OA and SA) were resolved through consultation with a third reviewer (PT), maintaining the rigor and objectivity of the review process.
+
+For all the selected studies, the following relevant data were systematically extracted: study aims, sample size and characteristics, geographical location, data collection and analysis methods, and key findings. To ensure the inclusion of the most recent literature, alerts were set up in the databases to capture newly published relevant studies during the review period.
+
+A thematic synthesis and the IMRAD (Introduction, Methods, Results, and Discussion) approach [23] were employed to categorize and interpret the data, enabling the identification of recurring themes, current challenges, and emerging trends in the nursing management of sexual dysfunction among cancer patients. Additionally, backward citation tracking (snowballing) was employed by reviewing the reference lists of relevant articles, helping to uncover additional studies that may have been missed in the original search.
+
+The insights gained through this comprehensive review were critically evaluated and integrated into the main body of the manuscript, providing both a broad overview and a detailed interpretation of the current evidence landscape on this important topic.
+
+3. Results
+
+A total of 50 studies met the inclusion criteria and were reviewed. The findings are organized into five thematic areas: (1) prevalence and impact of sexual dysfunction in cancer patients, (2) psychological and social impact of sexual dysfunction, (3) barriers to addressing sexual dysfunction in cancer care, (4) interventions for managing sexual dysfunction in cancer patients, and (5) nurses’ attitudes and beliefs about sexual health. Table 1 and Figure 1 provide a consolidated summary of these themes, highlighting key nursing-related interventions and barriers identified in each area.
+
+3.1. Prevalence and Impact of Sexual Dysfunction in Cancer Patients
+
+A detailed summary of the prevalence of sexual dysfunction, affected populations, and associated symptoms across different cancer types is provided in Table 2. In 2022, there were an estimated 20 million new cancer cases and 9.7 million cancer-related deaths globally [46]. While survival rates for many cancers have improved, the long-term consequences of cancer treatments, including sexual dysfunction, remain poorly understood [46]. Studies suggest that cancer survivors often experience long-term difficulties with intimacy, body image, and relationship satisfaction due to sexual dysfunction [46]. Despite the recognition of sexuality as a core component of quality of life, sexual health interventions remain inconsistent across healthcare systems worldwide [47]. The WHO advocated integrating sexual health assessments into cancer survivorship programs to ensure that patients receive comprehensive support that addresses both physical and psychological well-being [48].
+
+The prevalence of sexual dysfunction among cancer patients depends on their specific cancer diagnosis; the treatments they have received; and personal health factors such as age, sex, and pre-existing medical conditions [49]. In addition to direct physical symptoms, sexual dysfunction has also had a profound psychological effect on survivors. Physical changes and psychosocial challenges often lead to anxiety, depression, and self-consciousness, causing a loss of confidence and avoidance of intimacy [50,51]. However, survivors typically receive minimal information or support for managing these sexual side effects, resulting in prolonged distress and a diminished quality of life [28,29]. This lack of guidance exacerbates their difficulties, further reducing relationship satisfaction and negatively impacting mental health outcomes [31]. Despite how common and impactful these issues are, many patients remain reluctant to seek professional help for sexual dysfunction [24,25]. Feelings of embarrassment, stigma, or the assumption that sexual health is not a priority in cancer often discourage open discussion of these problems. Moreover, healthcare providers frequently lack the training, confidence, and institutional support to address sexual issues proactively in oncology practice [52,53]. Together, these factors create a significant gap in care delivery in regard to managing the sexual health of cancer survivors. Closing this gap requires a coordinated, multidisciplinary approach.
+
+Experts advocate implementing routine sexual health assessment as part of cancer follow-up and providing healthcare professionals with dedicated training and resources to manage cancer-related sexual problems, thereby making sexual well-being an integral component of standard survivorship care [52,53]. By ensuring that sexual health is fully integrated into survivorship programs, healthcare systems can better support the long-term quality of life of cancer survivors (Table 2).
+
+curroncol-32-00457-t002_Table 2 Table 2 Summary of the prevalence of sexual dysfunction among cancer patients, broken down by cancer type and gender.
+
+References	Cancer	Gender	Reported Prevalence	Common Manifestations/Concerns	
+[26,54,55,56]	Breast	F	16–100% (majority 50–75%)	Sexual difficulty, sexual pain, altered sexual self-image, reduced desire, vaginal dryness, dyspareunia	
+[27,28,56,57]	Gynecologic	F	30–100%	Vaginal dryness, dyspareunia, loss of sensation, decreased libido, hot flashes, difficulty achieving orgasm, and painful intercourse	
+[56,58]	Rectal (surgery)	F, M	19–62% (most ~60%)	Sexual dysfunction, body image concerns (stomas), and relationship issues.	
+[41,42,56]	Prostate	M	40–100%	Erectile dysfunction, loss of desire, problems reaching orgasm	
+[59]	Childhood cancer	F, M	~1/3 overall, ~½ with 1+ problem, 30% with 2+ problems	Difficulties relaxing/enjoying sex/becoming sexually aroused/achieving orgasm, erection difficulties (men), altered body image, fertility concerns	
+[60,61]	Hematologic (e.g., lymphoma)	F, M	54% decreased activity, 41% decreased interest	Decreased sexual activity, decreased sexual interest	
+[56]	Lung	F, M	~50% loss of libido (overall), ~40% decrease in sexual activity in F)	Loss of libido, decrease in sexual activity	
+[56]	Head and neck	F, M	24–100% negative impact	Negative impact on sexuality	
+F: female; M: male.
+
+3.2. Psychological and Social Impact of Sexual Dysfunction
+
+3.2.1. Impact on Partners
+
+Cancer-related sexual dysfunction affects not only patients but also their partners. Multiple studies have reported that partners often experience significant emotional distress, loneliness, and anxiety as they attempt to support their loved one through cancer and its sexual health challenges [29,62]. These partners frequently face a dual burden: concerns for the patient’s well-being and the strain of unmet intimacy needs. Qualitative evidence indicates that male partners of women with cancer, for example, describe feelings of isolation and a profoundly altered sexual relationship, underscoring the partner’s vulnerability in this context [29]. These findings highlight the need for partner-inclusive support, as addressing a couple’s needs (not just patients) is crucial to mitigating the psychosocial toll on partners and maintaining healthy relationship dynamics [29,62].
+
+3.2.2. Psychological Consequences
+
+Untreated individuals with sexual dysfunction can severely undermine the mental health of cancer survivors. Studies have linked sexual problems with elevated levels of psychological distress, notably increased anxiety, depressive symptoms, and reduced self-esteem, among cancer patients [32,33]. As sexual function declines or side effects (e.g., body image changes, pain) emerge, patients often report feeling a diminished sense of self and femininity/masculinity, which can lead to social withdrawal and isolation [32,33]. These psychological consequences are not isolated findings; instead, they appear consistently across diverse cancer populations. The emotional burden of sexual dysfunction is profound and pervasive, suggesting that survivors require not only medical treatment but also proactive psychosocial support to address issues such as fear, frustration, and loss of identity that accompany sexual health changes.
+
+3.2.3. Relational Strains
+
+Sexual dysfunction frequently places strain on intimate relationships. Research indicates that a decline in sexual intimacy and satisfaction can spark frustration, miscommunication, and conflict between partners, thereby eroding overall relationship quality [24,30]. In particular, couples who avoid discussing sexual issues tend to experience greater marital dissatisfaction. Communication about sexual health is often lacking, which exacerbates misunderstanding and emotional distancing [24,30]. Over time, this pattern of poor communication and unmet needs can lead to serious relational consequences. Some studies have documented cases of deteriorating partners’ relationships or even separation linked to unaddressed sexual problems in survivorship [20,30]. Conversely, couples who manage to maintain an honest dialog and seek help for sexual concerns typically fare better, highlighting communication as a key moderating factor. The literature, therefore, emphasizes that fostering healthy communication and providing counseling for couples is essential to prevent sexual dysfunction from translating into a long-term relational breakdown.
+
+3.2.4. Coping Mechanisms
+
+Despite these challenges, sexuality remains fundamental to many patients’ quality of life and identity [31]. Survivors and their partners employ various coping mechanisms to navigate the sexual changes imposed by cancer and its treatment. Some individuals adopt personal coping strategies, such as mindfulness and other stress reduction techniques, which have been associated with lower distress and better emotional adjustment in the face of cancer-related sexual problems [61]. Engaging in psychosocial support, such as joining support groups or couples’ therapy, is another coping avenue that can help normalize conversations about sexual health and reduce feelings of isolation. In addition, experts underscore that effective coping often requires external intervention: comprehensive strategies that address both the physical and psychological aspects of sexuality are advocated as best practices [63,64]. Integrative intervention (combining medical management of symptoms with counseling or sex therapy) has been recommended to bolster patients’ and partners’ coping capacity, enabling them to adapt to sexual changes while preserving emotional intimacy [63,64].
+
+Across the reviewed studies, sexual dysfunction in cancer patients has emerged as a multidimensional problem with consistently observed psychological and social ramifications. Numerous publications spanning different cancer types and cultural contexts document the same core issues: heightened emotional distress and interpersonal difficulties resulting from untreated sexual health concerns [24,32,33]. Notably, earlier works draw attention to the prevalence and seriousness of these psychological impacts (for instance, raising awareness that sexuality should not be overlooked even in life–threatening illnesses) [33]. More recent research has shifted toward identifying protective factors and solutions, such as mindfulness-based coping and holistic intervention programs, reflecting a growing focus on mitigation rather than merely describing the problem [61,63]. This trend signifies an important evolution in the literature: from recognizing that sexual dysfunction profoundly affects patients and their partners to actively exploring ways to buffer its impact. Collectively, the evidence underscores that integrating psychosocial support into sexual health is essential for improving cancer survivors’ quality of life and maintaining healthy relationships in survivorship [63,64].
+
+3.3. Barriers to Addressing Sexual Dysfunction in Cancer Care
+
+Despite growing awareness of the importance of sexual well-being in cancer survivorship, multiple barriers continue to hinder its integration into oncology nursing care. These challenges arise at various levels, including personal discomfort and limited communication skills among nurses [29,34,35], cultural and religious taboos that discourage open dialog [36,65], institutional constraints such as the absence of protocols and time pressure [24,30,38,39,40,66], and patient-related factors such as embarrassment or uncertainty about discussing sexual concerns [24,62,65,67]. As summarized in Table 3, these barriers interact to create systemic silence around sexual dysfunction, limiting nurses’ ability to address this critical aspect of holistic cancer care.
+
+3.4. Interventions for Managing Sexual Dysfunction in Cancer Patients—Training Programs to Build the Trust of Patients and Achieve Holistic Cancer Care
+
+Oncology nurses play a pivotal role in delivering targeted interventions that span educational, pharmacological, psychosocial, and multidisciplinary strategies. Evidence supports nurse-led sexual health education programs, the use of validated communication models, psychosexual counseling, pharmacologic therapies, digital programs, and collaborative care as essential components of a holistic treatment approach [7,30,42,62,73,74,75]. This intervention, summarized in Table 4, has demonstrated effectiveness in improving sexual health outcomes, increasing patients’ satisfaction, and enhancing the confidence and competence of nurses in addressing this sensitive topic.
+
+3.5. How to Deal with Attitudes and Beliefs of Nurses About Sexual Health
+
+3.5.1. Personal Beliefs and Knowledge Gaps
+
+Attitudes of nurses toward sexuality significantly shape their willingness and ability to initiate sexual health discussions with cancer patients. Many nurses perceive sexuality as a private matter and express discomfort during clinical interaction, fearing that it may offend patients or be considered unprofessional [35,73]. This discomfort often stems from a lack of formal academic preparation and limited clinical exposure to sexual health topics [34,45]. For example, Jordanian students have reported feeling unprepared to address sensitive issues such as the sexual needs of terminally ill patients [59]. Instead, they often rely on informal knowledge, which may not be sufficient to manage the complexities of cancer-related sexual dysfunction. This emphasizes the need to integrate structured sexual health content into nursing curricula and continuous professional development programs [79].
+
+3.5.2. Culture and Religious Influences
+
+In many conservative societies, sexuality remains a taboo topic, and healthcare providers, especially nurses, may avoid discussing it to conform to social expectations [37,50,69]. These cultural constraints can blur the boundaries between professional responsibilities and personal values, making it difficult for nurses to provide unbiased patient-centered care [65,70]. Additionally, patients themselves may feel too embarrassed to initiate such a discussion, instead expecting the healthcare provider to lead this conversation [35,66]. This dynamic often leads to mutual avoidance of sexual health discussion. Cultural and religious influences have a profound impact on both nurses and patients. Overcoming this requires fostering an environment that respects cultural sensitivities while promoting open, professional communication about sexuality.
+
+3.5.3. Experience, Gender, and Communication Challenges
+
+Nurses with more experience in oncology or palliative care are more likely to feel comfortable discussing sexual dysfunction with patients [62,67]. In contrast, novice nurses often avoid this discussion due to a lack of confidence; moreover, gender dynamics further complicate communication. Nurses may feel uneasy when addressing sexual issues with patients of the opposite sex, particularly in a traditional cultural context where such interactions are considered inappropriate [39]. This discomfort intensifies when institutional policies do not support sexual health as a routine component of care. Experience plays a protective role in fostering nurse confidence, but institutional support and cultural adaptation are equally necessary to overcome gender-based communication barriers.
+
+3.5.4. Institutional Roles and Professional Development
+
+When institutions provide clear polices, a supportive environment, and professional development opportunities focused on sexual health, nurses become more proactive in addressing these concerns [24,30,31]. Interventions such as role-playing exercises, structured communication training, and continuing education workshops have been shown to increase nurses’ comfort and perceived competence in this area [73,80]. Institutional initiatives and professional development programs are effective strategies for transforming a hesitant attitude into proactive sexual health engagement. Structured support not only improves clinical confidence but also ensures that patients receive holistic cancer care that includes their sexual well-being.
+
+The literature reveals that while oncology nurses understand the importance of sexual health, many feel unequipped in managing related discussions because of personal discomfort, cultural influences, a lack of education, and institutional neglect. Bridging this gap requires multilevel approaches, integrating sexual health in nursing education, promoting cultural competence, offering experiential training, and embedding sexual health into routine oncology care guidelines.
+
+3.5.5. Global Effort in Oncology Sexual Health Education in Recent Years
+
+There has been increasing global recognition of the need to improve sexual healthcare within oncology services. Academic institutions and healthcare systems in North America, in particular, have developed structured educational programs targeting oncology providers.
+
+In Canada, the trueNTH (true North sexual health and rehabilitation e-training) program has been implemented to increase the competencies of prostate cancer care providers. A multicenter evaluation demonstrated significant improvement in participants’ sexual health knowledge and communication self-efficacy, with almost all participants reporting high satisfaction with the program [81]. Similarly, in Alberta, a dedicated oncology sexual health clinic received over 130 patient referrals in two years, identifying diagnoses of sexual dysfunction in 100% of female patients and 80% of male patients [82]. Ms. Anne Katz, based in Manitoba, should be applauded for her longstanding contributions to sexual health [83]. The Princess Margaret Cancer Center in Toronto has developed hybrid in-person and virtual sexual health services, expanding access to specialized care for a broader patient population [83].
+
+In the United States, the Fox Chase Cancer Center launched the iSHARE (improving Sexual Health and Augmenting Relationships through Education) intervention, which focused on enhancing the ability of breast cancer clinicians to discuss sexual health interventions, leading to increased clinician confidence and sustained patient satisfaction [43].
+
+Internationally, the 2024 summit organized by the scientific network on female sexual health and cancer exemplified a growing effort to promote interdisciplinary education and collaborative models of care [68]. These global initiatives provide compelling evidence that structured education and clinical services significantly enhance sexual health outcomes in oncology.
+
+4. Discussion
+
+In summary, this narrative review highlights that sexual dysfunction is common among cancer patients and profoundly impacts their physical health and psychological and relational well-being. Sexual side effects of cancer and its treatment (e.g., erectile dysfunction, vaginal dryness, and dyspareunia) often lead to a loss of libido, body-image concerns, and strains on intimacy [7,8,58]. Patients report high levels of anxiety and depression associated with unmet sexual needs [11,84]. Significantly, sexual health interventions (e.g., counseling, education) can ameliorate these effects. Studies have shown that targeted sexual health information reduces patients’ anxiety and improves their satisfaction and quality of life [84,85]. The review also underscores the pivotal role of oncology nurses. Nurse-led interventions (using models such as PLISSIT and BETTER) enable sensitive discussion and management of sexual concerns [46,48]. For example, structured programs for nurses have been shown to improve knowledge, confidence, and communication skills [73,86]. Canadian initiatives such as trueNTH e-training have yielded significant gains in provider knowledge and self-efficacy (with 98% satisfaction), effectively preparing nurses to support the sexual health of prostate cancer patients [71]. These interventions align with clinical guidelines: both the ASCO and the NCCN now recommend routine screening for sexual problems and timely referral for specialist care [5,34]. However, multiple barriers prevent the delivery of effective care. Across settings, nurses report a lack of knowledge and training as a primary obstacle [30,38]. Many nurses feel embarrassed or ill prepared; for example, 85% of Belgian oncology nurses and 70% of U.S. nurses in separate studies admitted to discomfort when discussing sexual issues [62,86]. Time constraints and systemic factors (no private space or protocols) are common hurdles [1,87]. Cultural and social taboos further compound these barriers. In conservative societies (e.g., the Middle East, China, and parts of Africa), discussing sexuality is considered shameful, thus discouraging both patients and providers from approaching the subject [49,77]. In Iran or Africa, women with breast cancer, for example, often feel profoundly shameful due to religious and familial norms, leading them to hide sexual problems [27,54]. Even among Western–trained nurses, cultural assumptions (e.g., patients must be grateful to be alive and not need sex) can inhibit discussion [12,26].
+
+4.1. Comparisons with the Literature
+
+These findings corroborate the findings of international nursing studies. Global surveys find that only a minority of oncology clinicians regularly address sexual health; for example, in a Latin American study, only ~10% of physicians felt adequately prepared to manage sexual issues, and ~30% rarely broached the topic [79]. The education gap noted by this review aligns with conclusions from systematic analyses: nurses worldwide recognize sexual health as important, but they report inadequate curricula and on-the-job training [1,24,25]. Recent evidence from the past few years further reinforces these points. Concept mapping in Hong Kong highlighted the need for culturally adapted care models (an extended PLISSIT) to fit the local practice environment [52]. The current adult survivorship guidelines of the National Comprehensive Cancer Network of the United States (NCCN) in 2024 explicitly advocate routine sexual function screening and multidisciplinary referral, reflecting an international shift toward the integration of sexual rehabilitation in cancer [5,34]. Recent oncology nursing studies have reinforced the notion that targeted interventions can make a significant difference. For example, a scoping review revealed that a brief active–learning workshop (e.g., role-play using PLISSIT scenarios) significantly improved nurses’ communication comfort and knowledge [1,73,86]. Novel e-learning modules (such as those for adolescent/young adult cancer patients) have been shown to increase awareness of reproductive and sexual health issues among oncology staff [53,57]. Notably, the current review’s Middle East context aligns with new data: a 2025 Jordanian survey reported similar barriers (time, training, and culture) and called for system-level educational reforms [1]. Conversely, research from countries with dedicated sexual health clinics (e.g., Canada’s multidisciplinary clinics) suggests that nurse involvement in such teams leads to more diagnoses and interventions for dysfunction, again supporting the central role of nursing [71,88]. Overall, these additional studies corroborate our narrative review findings and highlight growing global momentum toward addressing cancer-related sexual dysfunction as a standard component of care. This review adds to the current literature in a timely manner by summarizing current information and discussing practical solutions to the growing global problem, as more patients survive initial cancer treatment to address posttreatment sexual health complications.
+
+4.2. Implications for Practice, Policy, and Education
+
+Given these insights, several practical implications emerge. Clinically, oncology nurses should be empowered to initiate sexual health conversations routinely. Models such as the 5 A’s (Ask, Assess, Advise, Assist, Arrange) and structured frameworks (PLISSIT/BETTER) provide practical guides for nurses to normalize discussions and offer basic interventions [46,47,89].
+
+Nurses and nurse practitioners can help mitigate physical side effects through anticipatory guidance—for example, by recommending lubricants, topical vaginal estrogen creams, vaginal dilators, and pelvic floor exercises. They can also connect patients to appropriate specialists for more complex issues, such as sex therapists, fertility counselors, and urologists [80,90]. For instance, nurses can collaborate with other team members, including family physicians and pharmacists, to select the most suitable phosphodiesterase inhibitor for an individual patient, taking into account cardiac comorbidities and lifestyle factors. In general, sildenafil acts more quickly but has a shorter duration of effect compared to tadalafil.
+
+Additionally, nurses can refer patients to plastic surgeons for breast or testicular prostheses. Some men may experience distress following orchiectomy, and the insertion of a testicular prosthesis comparable in size to the contralateral testicle can significantly improve body image.
+
+The evidence suggests that even brief interventions by nurses providing permission, education, and simple suggestions can significantly improve sexual function outcomes (up to 70% of patients can return to baseline with intervention [7,66,91]). Thus, oncology units should allocate time and privacy for these assessments [86].
+
+In terms of policy, institutions and professional organizations must prioritize sexual health. Cancer care guidelines should formally include sexual function as a survivorship quality metric. For example, the NCCN now lists “sexual health” under long-term effects in its survivorship guidelines [5,34]. Hospitals could adopt standardized sexual history checklists in electronic records and track sexual health referral rates as a quality indicator [71]. Reimbursement and scheduling policies should recognize sexual counseling as part of patients’ care. In culturally conservative contexts, policy and administration can facilitate gender-sensitive care (e.g., ensuring the availability of female providers for intimate issues) and provide private settings for discussions.
+
+National health bodies might consider public education campaigns to destigmatize post-treatment sexual issues, as in some Western countries [49,77]. For nursing education, curricula must be revamped. Both pre-licensuring and continuing education programs should incorporate content related to sexual health, anatomy, communication skills, psychosocial aspects, and cultural competence. Simulation and role play (which nurses find highly effective) can prepare nurses to handle these sensitive topics [28,73]. Promising training programs, such as ENRICH (Educating Nurses about Reproductive Issues in Cancer Healthcare, a web-based program on fertility/sexuality training for pediatric oncology nurses), should be expanded to all oncology specialties [57,71]. Academic nursing programs in conservative societies should emphasize that discussing sexuality is integral to holistic cancer care and teaching students to use neutral, validating language. Professional development initiatives (workshops, online modules) are needed to close the current knowledge gap. One review explicitly recommended the creation of oncology nurse training programs to improve attitudes and skills related to sexual health [29,42]. Collectively, these steps can transform the culture of care so that sexual well-being is routinely addressed.
+
+4.3. Strengths and Limitations of the Review
+
+This narrative review offers a broad synthesis of nursing roles in sexual dysfunction, drawing on diverse sources across cultures and practice settings. Its strengths include integrating recent evidence (e.g., studies from 2024 to 2025) and highlighting underrecognized factors (such as cultural taboos in conservative societies) [1,77]. Focusing on nursing perspectives, this review fills a gap left by many reviews, mostly written for medical doctors [5,53]. The authors’ experiences in the Middle East and China provide valuable insights into taboo barriers. The reference section includes the most important recent studies, and this review is poised to provide valuable guidance for clinicians, nurses, and researchers.
+
+As a narrative (rather than systematic) review, it is subject to specific limitations. Unlike a systematic review, the search strategy may not have been comprehensive; narrative syntheses do not require appraisal. Important studies might have been missed, and the selection of literature can reflect author bias [25,55]. Additionally, without a standardized methodology, reproducibility may be limited. The review mentions primarily English-language and peer-reviewed sources, potentially omitting the other relevant literature or non-English research (e.g., local studies in Asia/Africa) [29,53]. Some of the studies suffer from cultural inhomogeneity, a lack of longitudinal studies, and/or poor methodological quality. Finally, without a meta-analysis, the review provides only a qualitative conclusion regarding different settings in low- versus high-income countries and different cultures. Table 5 summarizes this perspective. Thus, the findings should be interpreted as reflective insights grounded in expert synthesis rather than conclusive empirical evidence.
+
+4.4. Recommendations and Future Directions for Research
+
+Future research should evaluate and refine specific nursing interventions to increase their effectiveness. Randomized trials or controlled studies could test the impact of nursing-led sexual counseling on patient outcomes [46,47]. Comparative research should identify which educational methods (e.g., in-person workshops vs. online modules) are most effective in improving nurses’ competence [73,86]. Culturally tailored models deserve study, for example, by assessing interventions that respect social norms in Middle Eastern or African contexts [49,77]. Research gaps include male sexuality (most studies focus on women) and underserved groups, such as low-income or LGBTQ (Lesbian, Gay, Bisexual, Transgender, Queer or Questioning) patients [7,87]. Health services research could explore how institutional changes (e.g., establishing oncology–sexuality clinics) impact the quality of care [71,88]. Education and training initiatives must be expanded. Oncology units should implement routine sexual health training for all healthcare staff, with refresher sessions to maintain skills [52,57].
+
+5. Conclusions
+
+Empowering nurses through structured education, standardized guidelines, and open communication strategies is essential for improving patient outcomes. Addressing sexual dysfunction as a routine aspect of cancer care will enhance survivors’ quality of life and foster a more holistic approach to oncology treatment.
+
+This research was conducted by a team of researchers with origins in the Middle East and China, both of whom represent conservative traditions and diverse religious backgrounds. This concise overview, which is rich in detailed references and clinical pearls, offers a unique and highly educational resource for healthcare professionals across multiple disciplines, such as nurses, physicians, social workers, psychologists, music therapists, sex therapists, and chaplains. It therefore has broad clinical implications, and practical suggestions will greatly benefit cancer patients and their providers from different disciplines.
+
+Author Contributions
+
+O.A. and S.A.-G.: conceptualization, methodology, software, investigation. O.A., S.A.-G., E.Y., and P.T.: resources, writing—original draft preparation, writing—review, and editing. All the authors, including K.J., K.W., and E.Y., critique the manuscript drafts. All authors have read and agreed to the published version of the manuscript.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Abbreviations
+
+The following abbreviations are used in this manuscript: 5 A’s	Ask, Assess, Advise, Assist, Arrange	
+BETTER	B: bringing up the topic. E: Explain that you are concerned with all aspects of patients’ lives. T: Tells patients that sexual dysfunction is common. T: Timing might not be right now, but you are open to future discussion. E: Educate patients about sexual side effects. R: Record the conversation in the medical records	
+CINAHL	Cumulative Index to Nursing and Allied Health Literature	
+ENRICH	Educating Nurses about Reproductive Issues in Cancer Healthcare	
+IMRAD	Introduction, Methods, Results, and Discussion	
+LGBTQ	Lesbian, Gay, Bisexual, Transgender, Queer or Questioning	
+NCCN	National Comprehensive Cancer Network	
+PLISSIT	P: Permission. LI: Limited Information. SS: Specific Suggestions. IT: Intensive Therapy.	
+
+Figure 1 The conceptual framework summarizes barriers, interventions, and outcomes related to nursing care in individuals with sexual dysfunction.
+
+curroncol-32-00457-t001_Table 1 Table 1 Thematic summary.
+
+Thematic Area	Summary Point	References	
+Prevalence and impact of sexual dysfunction	Sexual dysfunction is highly prevalent (affecting approximately 50–70% of survivors). It has a significant negative impact on quality of life and intimate relationships, yet it often remains underrecognized in oncology practice. Addressing this issue requires integrating sexual health into routine survivorship care.	[18,24,25,26,27,28,29]	
+Psychological and social impact	Untreated sexual dysfunction leads to psychological distress (e.g., anxiety, depression) and social problems such as relationship strain and isolation. A lack of open communication about sexual issues can exacerbate these psychological outcomes, indicating a need for holistic support for patients and partners.	[24,30,31,32,33]	
+Barriers in cancer care	Oncology nurses face multifaceted barriers–personal (insufficient training, low confidence), cultural (taboos, religious norms), and institutional (absence of guidelines, time constraints)– that hinder discussions of sexual health. These barriers contribute to a gap in care, as many patients’ sexual concerns go unaddressed.	[34,35,36,37,38,39,40]	
+Interventions for managing sexual dysfunction	A range of nursing interventions can improve sexual health outcomes: patients’ education and counseling (including models like PLISSIT and BETTER), appropriate use of medications (e.g., PDE5 inhibitors for erectile dysfunction, vaginal moisturizers or estrogen for dyspareunia), and multidisciplinary approaches (involving oncologists, psychologists, and sex therapists). Implementing these interventions—alongside nurse training programs and sexual health clinics—has been shown to increase patients’ satisfaction and sexual functioning. Clinical guidelines now recommend proactive sexual rehabilitation as part of standard cancer care.	[7,24,30,41,42,43]	
+Nurses attitudes and beliefs	Nurses’ attitudes and beliefs can significantly impact sexual healthcare. Many nurses feel uncomfortable or believe sexual matters are too private to discuss, often due to cultural/religious influences or lack of training. Such attitudes can prevent essential conversations, training, and education. Hence, its integration into nursing curricula and professional development, along with supportive institutional polices, is crucial to change perceptions and empower nurses to address sexual dysfunction confidently.	[30,34,35,36,37,44,45]	
+BETTER: B: bring up the topic, E: explain that you are concerned with all aspects of patients’ lives, T: tell patients that sexual dysfunction is common, T: timing might not be right now, but you are open to future discussion, E: educate patients about sexual side effects, R: record the conversation in the medical record; PDE5: phosphodiesterase type (inhibitors); PLISSIT: P: permission, LI: limited information, SS: specific suggestions, IT: intensive therapy.
+
+curroncol-32-00457-t003_Table 3 Table 3 Summary description of barriers to addressing sexual dysfunction.
+
+Barrier	Description	References	
+Provider discomfort and training deficits	Many healthcare providers lack specific sexual health training and feel anxious or unprepared to discuss intimacy topics. This leads to the avoidance of sexual health conversations to prevent offending patients.	[34,43,68]	
+Cultural and religious norms	In many cultures, sexual topics are taboo. Providers fear violating social norms and may face adverse reactions. Such taboos create strong reluctance for both providers and patients to bring up sexual issues.	[36,37,45,69,70,71]	
+Institutional constraints	Hospital often has no standardized protocol or guidelines for addressing sexual health, and nurses have limited time in busy oncology settings. Lack of institutional support (e.g., training resources, specialized experts) further hinders the integration of sexual health into routine care.	[24,30,38,39,40,66,72]	
+Patient-related factors	Patients themselves frequently feel embarrassed or uncertain about the relevance of sexual health issues and may prefer providers to initiate the topic. Many reports indicate that it is easier to discuss sexual concerns with a same gender provider, and both sides often wait for the other to speak first, resulting in unmet needs.	[24,40,62,65,72]	
+
+curroncol-32-00457-t004_Table 4 Table 4 Summary descriptions of interventions for managing sexual dysfunction in cancer patients.
+
+Intervention	Description	References	
+Nurse-led education and counseling	Structured sexual health education and counseling sessions (e.g., BETTER Model) help patients understand treatment-related changes and coping strategies. A nurse-led program improves patients’ knowledge about the physical and emotional aspects of sexuality after cancer.	[7,44,74]	
+Pharmacological treatment	Medication can directly address physical dysfunction, e.g., phosphodiesterase-5 inhibitors (sildenafil, tadalafil) improve post-treatment erectile function, and topical estrogen therapies with vaginal moisturizers relieve vaginal atrophy and dyspareunia. Nurses play a key role in informing patients about this treatment and managing side effects.	[41,42,53,66,75]	
+Psycho-Sexual therapy	Individual and couple counseling (psychosexual therapy) addresses the emotional and relational impact of sexual dysfunction. Clinical studies show that such counseling improves sexual satisfaction, reduces anxiety, and enhances partners’ communication. Nurse-led psychosexual support provides emotional assistance along with practical suggestions for intimacy.	[30,31,42,62]	
+Multi-disciplinary team care	Collaborative care involving oncologists, nurses, psychologists, physiotherapists, and sex therapists creates comprehensive treatment plans. Establishing dedicated sexual health clinics within oncology departments has been shown to improve patients’ outcomes and satisfaction.	[24,30,62,73]	
+Digital and Telehealth intervention	Telemedicine platforms, online education modules, and virtual support groups offer accessible sexual health resources. These can overcome geographic and stigma barriers, allowing confidential counseling and education. Studies find digital programs help patients engage with sexual healthcare despite time or cultural constraints.	[44,75,76,77]	
+Nurse training and frameworks	Targeted training programs and communication frameworks (e.g., PLISSIT or stepped-skill models) build nurses’ confidence and skills. Education and systems-based strategies (workshops, protocols) are shown to increase their competence in discussing sexual concerns and conducting more proactive and routine sexual health assessments.	[7,24,30,45,62,74,75,78,79,80]	
+BETTER: B: Bringing up the topic. E: Explain that you are concerned with all aspects of patients’ lives. T: Tells patients that sexual dysfunction is common. T: Timing might not be right now, but you are open to future discussion. E: Educate patients about sexual side effects. R: Record the conversation in the medical records; PLISSIT, P: Permission. LI: Limited Information. SS: Specific Suggestions. IT: Intensive Therapy.
+
+curroncol-32-00457-t005_Table 5 Table 5 Comparative overview of how nursing roles in addressing sexual dysfunction among oncology patients differ between high-income countries and low- and middle-income countries.
+
+	High-Income Countries	Low- and Middle-Income Countries	
+Training and education	Specialized training programs like TrueNTH (Canada) and iSHARE (USA) enhance nurses’ confidence and skills in sexual health communication.	Limited access to formal training; nurses often lack education in sexual health and oncology-specific sexual dysfunction.	
+Clinical guidelines	National guidelines (e.g., ASCO, NCCN) recommend routine screening and referrals for sexual dysfunction.	Guidelines are often absent or not enforced; sexual health is rarely integrated into oncology care plans.	
+Multidisciplinary clinics	Dedicated sexual health clinics exist within cancer centers (e.g., Alberta, Manitoba in Canada).	Few or no specialized clinics; care is fragmented and often deprioritized due to resource constraints.	
+Cultural acceptance	Increasing openness to discussing sexual health; use of structured models like PLISSIT and BETTER.	Cultural taboos and stigma inhibit open discussions; patients and providers may avoid the topic entirely.	
+Patient engagement	Patients are encouraged to voice concerns; nurses initiate conversations during survivorship planning.	Patients rarely disclose sexual concerns due to embarrassment, stigma, or belief that dysfunction is inevitable.	
+Access to resources	Availability of lubricants, dilators, sex therapy referrals, and pelvic floor physiotherapy.	Limited or no access to sexual health resources; interventions are often nonpharmacological due to cost.	
+Technology and innovation	Using online modules, telehealth, and digital tools for training and patient support.	Minimal technology use; infrastructure and internet access may be barriers.	
+ASCO, American Society of Clinical Oncology; BETTER, B: Bringing up the topic. E: Explain that you are concerned with all aspects of patients’ lives. T: Tells patients that sexual dysfunction is common. T: Timing might not be right now, but you are open to future discussion. E: Educate patients about sexual side effects. R: Recorded the conversation in the medical records; iSHARE, improved Sexual Health and Augmented Relationships through Education; NCCN, National Comprehensive Cancer Network; PLISSIT, P: Permission. LI: Limited Information. SS: Specific Suggestions. IT: Intensive Therapy; TrueNTH: True North Sexual Health and Rehabilitation eClinic.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
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+61. Olsson C. Sandin-Bojö A.K. Bjuresäter K. Larsson M. Changes in sexuality, body image and health related quality of life in patients treated for hematologic malignancies: A longitudinal study Sex. Disabil. 2016 34 367 388 10.1007/s11195-016-9459-3 27881887 PMC5102943
+62. Quinn C. Platania-Phung C. Bale C. Happell B. Hughes E. Understanding the current sexual health service provision for mental health consumers by nurses in mental health settings: Findings from a survey in Australia and England Int. J. Ment. Health Nurs. 2018 27 1522 1534 10.1111/inm.12452 29575550
+63. Harris M.G. Sexuality and menopause: Unique issues in gynecologic cancer Semin. Oncol. Nurs. 2019 35 211 216 10.1016/j.soncn.2019.02.008 30871843
+64. Al-Ghabeesh S.H. Al-Kalaldah M. Rayan A. Al-Rifai A. Al-Halaiqa F. Psychological distress and quality of life among Jordanian women diagnosed with breast cancer: The role of trait mindfulness Eur. J. Cancer Care 2019 28 e13082 10.1111/ecc.13082 31066145
+65. Zeng Y.C. Liu X. Loke A.Y. Addressing sexuality issues of women with gynecological cancer: Chinese nurses’ attitudes and practice J. Adv. Nurs. 2012 68 280 292 10.1111/j.1365-2648.2011.05732.x 21658098
+66. Reese J.B. Beach M.C. Smith K.C. Bantug E.T. Casale K.E. Porter L.S. Bober S.L. Tulsky J.A. Daly M.B. Lepore S.J. Effective patient-provider communication about sexual concerns in breast cancer: A qualitative study Support. Care Cancer 2017 25 3199 3207 10.1007/s00520-017-3729-1 28451911 PMC5803445
+67. Al-Ghabeesh S.H. Bashayreh I.H. Saifan A.R. Rayan A. Alshraifeen A.A. Barriers to effective pain management in cancer patients from the perspective of patients and family caregivers: A qualitative study Pain Manag. Nurs. 2020 21 238 244 10.1016/j.pmn.2019.07.011 31494027
+68. Roushar A. 9th Conference of the Scientific Network of Female Sexual Health and Cancer. Cancersexnetwork.org 2024 Available online: https://www.cancersexnetwork.org/events/annual-meeting/past-meetings/2024 (accessed on 13 August 2025)
+69. Eid K. Christensen S. Hoff J. Yadav K. Burtson P. Kuriakose M. Patton H. Nyamathi A. Sexual health education: Knowledge level of oncology nurses and barriers to discussing concerns with patients Clin. J. Oncol. Nurs. 2020 24 E50 E56 10.1188/20.CJON.E50-E56 32678358
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+71. Oskay Ü. Can G. Başgöl S. Discussing sexuality with cancer patients: Oncology nurses attitudes and views Asian Pac. J. Cancer Prev. 2014 15 7321 7326 10.7314/APJCP.2014.15.17.7321 25227836
+72. Moore A. Higgins A. Sharek D. Barriers and facilitators for oncology nurses discussing sexual issues with men diagnosed with testicular cancer Eur. J. Oncol. Nurs. 2013 17 416 422 10.1016/j.ejon.2012.11.008 23290540
+73. Available online: https://www.blueberrytherapy.ca/post/breaking-the-silence-addressing-the-stigma-surrounding-women-s-sexual-health-in-healthcare-settings (accessed on 1 August 2025)
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+75. Mrad H. Chouinard A. Pichette R. Piché L. Bilodeau K. Feasibility and impact of an online simulation focusing on nursing communication about sexual health in gynecologic oncology J. Cancer Educ. 2024 39 3 11 10.1007/s13187-023-02366-w 37698822
+76. Sousa Rodrigues Guedes T. Barbosa Otoni Gonçalves Guedes M. de Castro Santana R. Costa da Silva J.F. Almeida Gomes Dantas A. Ochandorena-Acha M. Terradas-Monllor M. Jerez-Roig J. Bezerra de Souza D.L. Sexual dysfunction in women with cancer: A systematic review of longitudinal studies Int. J. Environ. Res. Public Health 2022 19 11921 10.3390/ijerph191911921 36231221 PMC9564951
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+81. de Vocht H. Hordern A. Notter J. van de Wiel H. Stepped Skills: A team approach toward communication about sexuality and intimacy in cancer and palliative care Australas. Med. J. 2011 4 610 619 10.4066/AMJ.2011.1047 23386876 PMC3562918
+82. Suvaal I. Hummel S.B. Mens J.M. Tuijnman-Raasveld C.C. Tsonaka R. Velema L.A. Westerveld H. Cnossen J.S. Snyers A. Jürgenliemk-Schulz I.M. Efficacy of a nurse-led sexual rehabilitation intervention for women with gynecological cancers receiving radiotherapy: Results of a randomized trial Br. J. Cancer 2024 131 808 819 10.1038/s41416-024-02775-8 38961193 PMC11369252
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+
+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Curr Oncol
+Journal ID: Curr Oncol
+NLM Journal ID: 9502503
+Journal ID: curroncol
+
+Current Oncology
+
+ISSN: 1198-0052
+EISSN: 1718-7729
+Publisher: Multidisciplinary Digital Publishing Institute (MDPI)
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC11431418
+PMID: 39330034
+DOI: 10.3390/curroncol31090406
+Article ID: curroncol-31-00406
+Article version: 1
+Subjects: Review
+
+Shared-Care in Complex Malignant Hematology: An Integrative Review Using the RE-AIM Evaluation Framework
+
+https://orcid.org/0000-0002-0954-371X Nixon Shannon M. 1 *
+Maze Dawn C. 2
+https://orcid.org/0000-0002-6941-1380 Parry Monica 3
+https://orcid.org/0000-0002-0083-5679 Mayo Samantha J. 1
+1 Princess Margaret Cancer Centre, Lawrence Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON M5S 1A1, Canada; samantha.mayo@utoronto.ca
+2 Princess Margaret Cancer Centre, Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 1A1, Canada; dawn.maze@uhn.ca
+3 Lawrence Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON M5S 1A1, Canada; monica.parry@utoronto.ca
+* Correspondence: shannon.nixon@uhn.ca or shannon.nixon@mail.utoronto.ca
+Electronic publication date: 2024 Sep 14
+Publication date: 2024 Sep
+Volume: 31
+Issue: 9
+First page: 5484
+Last page: 5497
+Received 2024 Aug 4; Revised 2024 Aug 29; Accepted 2024 Sep 12
+Copyright: © 2024 by the authors.
+Copyright year: 2024
+License: Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: complex malignant hematology, shared-care, RE-AIM, implementation, travel burden, health system
+
+Funding: This research received no external funding.
+
+Ÿ==============================Ÿ
+Complex malignant hematology (CMH) shared-care programs have been established to support patients with access to care closer to home. This integrative review examined what is known about CMH shared-care using the RE-AIM evaluation framework. We searched five electronic databases for articles published until 16 January 2024. Articles were included if they were qualitative or quantitative studies, reviews or discussion papers, and reported on an experience with shared-care (defined as a reciprocal, ongoing patient-sharing relationship between a specialist centre and community hospital) for patients with hematological malignancies, and examined one or more aspects of the RE-AIM framework. The search yielded 6523 articles; 10 articles describing eight shared-care experiences. Indicators of reach were reported for 65% of the programs, and emphasized some patient eligibility criteria. Effectiveness indicators were reported for 28% of programs, and suggested favourable survival outcomes within a shared-care model; however, health system impact and quality of life studies were lacking. Indicators of adoption and implementation were reported for 56% and 42% of programs, respectively, and emphasized multidisciplinary teams, infrastructure support, and communication strategies. Maintenance was not reported. Common elements contribute to the implementation of existing CMH shared-care programs; however, a formal evaluation remains an area of need.
+
+1. Introduction
+
+Complex malignant hematology (CMH) includes acute leukemia, high-grade lymphoma, or other hematologic malignancies requiring intensive therapies, such as chemotherapy that involves prolonged hospitalization, hematopoietic stem cell transplant or chimeric antigen receptor therapy (CAR-T) [1]. This group of cancers is generally associated with rapid onset, significant symptom burden, profound cytopenias, and risk of mortality. Given the complexity of care required, CMH patients are predominantly treated in academic cancer centres with specialized facilities, concentrated resources, and highly trained multidisciplinary healthcare providers [1,2].
+
+Travel to specialized centres may pose burdens for patients, including time toxicity and transportation expenses [3]. Patients who reside in rural locations are most vulnerable to these travel burdens [4]. Access to CMH services and quality specialized care becomes challenging, and may be a limiting factor in pursuing optimal therapy [5]. Additionally, as the CMH patient population continues to grow and age [6], there is increased pressure on specialist centres to develop innovative models of care to address capacity challenges. One way to address travel burden and capacity challenges is through expanding CMH programs by creating partnerships with community hospitals, allowing patients to receive some of their care closer to home.
+
+Partnerships between specialized centres and community hospitals have been established in other patient populations to address geographic barriers to specialized medical care. Cohen et al. [7] reported the implementation of a shared-care model in which children with chronic conditions associated with medical fragility received complex symptom management at a community-based clinic staffed by pediatricians and nurse practitioners, affiliated with a specialist centre. Consultations with physicians at the specialist centre were available as needed. Shared-care program outcomes included enhanced patient quality of life, decreased transportation expenses, and improved healthcare utilization [7].
+
+In the context of CMH, shared-care can enable patients to receive care on an ongoing basis from collaborative teams working in partnership across community and specialized centres. In Ontario, Canada, an acute leukemia shared-care program has been implemented, where patients receive complex care in specialist centres, and less intensive treatments and supportive care at community hospitals [8]. Hershenfeld et al. [9] evaluated this program, and found that patients who received supportive care at community hospitals within the shared-care model had reduced travel burden, and no difference in overall survival compared to patients treated at the specialist centre alone.
+
+Given the potential benefits of shared-care [7,9], clinicians and decision-makers would benefit from an understanding of what factors influence the successful implementation of CMH shared-care programs. The RE-AIM implementation science framework provides a guide for program evaluation, and has been widely applied to evaluate health services across a range of clinical settings and populations [10]. While other existing evaluation frameworks identify program components important for assessing implementation success [11,12,13], RE-AIM has the additional advantage of evaluating the potential for public health impact and broad program application [10]. As CMH shared-care programs may involve partnerships across specialized centres and community hospitals, it would be important to choose a framework to guide this review that addresses the potential for regional growth. This review will use the RE-AIM framework to examine what is known about the Reach, Effectiveness, Adoption, Implementation, and Maintenance of CMH shared-care [10].
+
+2. Methods
+
+An integrative literature review uses a comprehensive search strategy to provide a broad overview of current knowledge, including both qualitative and quantitative studies [14]. In January 2024, a search was conducted to identify articles reporting on CMH shared-care, which examined one or more RE-AIM framework dimensions [10]. Table 1 includes definitions used for the RE-AIM dimensions.
+
+The search strategy consisted of a search of the following electronic databases: Medline (1946 to 16 January 2024), EMBASE (1947 to 16 January 2024), Cochrane Database of Systematic Reviews (2005 to 16 January 2024) and Central Register of Controlled Trials (2014 to 16 January 2024), CINAHL via EBSCOhost (1974 to 16 January 2024), and Scopus via Elsevier (inception to 16 January 2024). Search terms were devised based on background reading and consultation among co-authors (SN, SM, DM, MP). Table 2 provides a sample search strategy for Medline. See Supplementary S1 for details of the search used for each database. A supplemental search of reference lists was also completed.
+
+Articles were included if they: (a) focused on individuals of any age receiving active therapy for CMH, defined as acute leukemia, high-grade lymphoma, or other hematologic malignancies requiring intensive therapies; (b) reported on a shared-care program, defined as a reciprocal, ongoing patient-sharing relationship between levels of care (malignant hematology specialist centre and community hospital); (c) reported on at least one RE-AIM framework dimension; (d) were published as qualitative or quantitative studies, reviews or discussion papers in peer-reviewed journals; (e) reported on shared-care in a high-income country as defined by the World Bank Atlas [16], to optimize comparability to the Canadian setting; and (f) were published in English. Articles were excluded if they reported patient-sharing with primary care, office settings, or palliative care. Conference abstracts, theses, and the grey literature were excluded.
+
+Search results were imported to Covidence for article selection. After removing duplicates, article selection occurred through two stages of double screening. In Stage 1, two reviewers (SN and SM) independently screened titles and abstracts for relevance to the research question. In Stage 2, full texts of any relevant citations in Stage 1 were retrieved and independently reviewed by SN and SM against inclusion and exclusion criteria to determine eligibility. Any conflicts between reviewers in stages 1 or 2 were resolved through discussion until a consensus was reached.
+
+Extracted data from each article included the country in which shared-care was provided, the target population of the model, program details, and RE-AIM outcomes. RE-AIM outcomes were extracted using a 21-item data collection tool adapted from RE-AIM.org, which has been used in previous reviews that reported on RE-AIM dimensions [15,17]. For each RE-AIM dimension, the presence or absence of indicators was coded (yes/no), and if present, a description of the indicator was extracted. Any reported facilitators and barriers of each dimension were collected, as identified by the authors. Supplementary S2 shows all extracted indicators. SN performed all extractions, and any uncertainties were discussed with SM.
+
+3. Results
+
+The search yielded 6523 articles after excluding duplicates. After title and abstract screening, followed by full-text screening (Figure 1), ten articles reporting on eight CMH shared-care programs were included; three papers authored by Jillella et al. [18,19,20] reported on the same CMH shared-care program and were grouped together for the purpose of analysis. All eight programs were described across observational studies (n = 4) [9,18,21,22], case series (n = 1) [23], qualitative studies (n = 1) [24], and discussion papers (n = 4) [19,20,25,26].
+
+Programs were reported in the United States of America (n = 3) [18,19,20,21,23], Canada (n = 2) [9,25], Australia (n = 1) [24], England (n = 1) [22], and Singapore (n = 1) [26]. Programs described patients diagnosed with acute leukemia (n = 5) [9,18,19,20,21,22,23], myeloproliferative neoplasm (MPN) (n = 1) [25], lymphoma (n = 1) [26], and a variety of hematologic malignancies (n = 1) [24]. Six programs described shared-care for adult patients [9,18,19,20,21,23,25,26]; and two programs reported on the pediatric experience [22,24]. Characteristics of the included programs are listed in Table 3 and Table 4 summarizes the proportion of CMH shared-care programs reporting RE-AIM dimensions and indicators.
+
+3.1. Reach
+
+The reach of a program considers the number and representativeness of patients willing to participate in a given initiative [10]. The methods used for selecting patients for CMH shared-care were described for most programs (6/8), though this occurred primarily from the specialist site, with the community hospital involvement not clearly addressed. For example, in a shared-care program for MPN, an intake questionnaire at the specialist centre was used to screen for disease subtypes that warrant specialist care involvement [25]. Facilitators for identifying patients for shared-care focused on strategies for enabling program referrals. For example, in Lim et al., [26] networking between hospital sites supported program awareness. In other centres, implementing standardized referral criteria facilitated the identification of appropriate patients and ensured efficiency and accuracy in referral prioritization [21,25].
+
+The inclusion criteria for patients accepted into shared-care were described for all programs (8/8). Diagnostic criteria included subtypes of disease that would require the involvement of specialist services not available at the community hospital [18]. Treatment criteria included types of therapy that involved an aspect of care that could be safely delivered in a community setting [9]. For some programs, the inability to travel to the specialized centre determined eligibility for shared-care [23]. Exclusion criteria were described in 2/8 programs. Some patients were excluded from participating if they preferred not to receive portions of their care at a community hospital [9]. Muir et al. [22] excluded acute leukemia patients if they did not achieve remission after intensive therapy at the specialist centre and, thus, were not eligible to receive maintenance therapy at the community hospital.
+
+The proportion of eligible patients who were enrolled in the CMH shared-care program was reported for 1/8 programs. In Muir et al. [22], 146 patients were deemed eligible, and 59 (40%) patients participated. The rationale for declined participation was not described. In Hershenfeld et al. [9], patients were encouraged to participate in shared-care; however, it was not mandatory, and the participation rate was not reported. None of the articles provided information about the representativeness of the enrolled patients to the overall patient population in those jurisdictions (0/8).
+
+3.2. Effectiveness
+
+The effectiveness of a program considers the measurement of primary outcomes, quality of life, and unintended negative consequences [10]. The effectiveness of the CMH shared-care programs on patient outcomes was reported by 4/8 programs. Patients receiving shared-care had improved or comparable survival outcomes compared to patients treated in specialist centres alone, or community hospitals alone [9,18,21,22]. For example, Hershenfeld et al. [9] evaluated patients with acute myeloid leukemia (AML) who received post-consolidation supportive therapy at community hospitals (n = 73), in comparison to patients who received care at the specialist centre alone (n = 344), and found no significant difference in survival between the groups: 90-day survival was 95.9% for shared-care and 95.3% for specialist centre patients. Table 5 summarizes the effectiveness data.
+
+No programs (0/8) reported unintended consequences, such as hospital admissions, infections, and other adverse events. The impact of shared-care on hospital resources was not reported. Outcomes related to patient quality of life were reported in two programs (2/8). In the study by Hershenfeld et al. [9] mean travel distance and travel time were significantly reduced for shared-care patients travelling to their local hospitals compared to commuting from their home to the specialist centre (87.8 km and 62 min compared to 14.5 km and 18 min, respectively). In Slater et al. [24], nurses perceived that patients in the shared-care programs had less anxiety and stress; a comparator was not provided.
+
+3.3. Adoption
+
+The adoption of a program assesses the number and representativeness of settings and staff who deliver a program [10]. All articles described some aspect of the CMH shared-care locations (8/8). Characteristics of the specialist centres included the level of healthcare provided and academic affiliation, as well as unique setting characteristics that would support specialist care. For example, specialist centres were defined as quaternary care [9], academically affiliated and a National Cancer Institute-designated cancer centre [23], and having an enhanced diagnostic pathology department for disease evaluation [25]. A description of participating community hospitals was not identified; however, Law et al. [21] described their shared-care program as part of a comprehensive, integrated healthcare delivery system comprised of 21 medical centres.
+
+Details of inclusion and exclusion criteria for specialist centre and community hospital participation in shared-care were identified in 2/8 programs. Goradia et al. [23] included only community hospitals with an already established partnership with the specialist centre. Hershenfeld et al. [9] included only community hospitals with transfusion and intensive care capabilities. For adoption rate, Hershenfeld et al. [9] described collaborating with 14 regional hospitals as part of their shared-care program; however, the total number of hospitals eligible for participation was not identified. Jillella et al. [18] worked with 29 community hospitals to implement shared-care; however, the number of hospitals approached for participation was not described.
+
+The methods used to identify CMH shared-care partnerships were rarely described (3/8). In these programs, specialist centre staff identified community hospitals for participation with various communication, education, and awareness strategies. For example, in Jillella et al., [18] specialist centre physicians visited the various community hospitals to meet with stakeholders and create awareness of the need for partnerships. Jillella et al. [18] identified that strengthening relationships between specialist centres and community hospitals through on-site visits and regular meetings facilitated staff onboarding for shared-care programs.
+
+The characteristics of clinical staff delivering shared-care from community and specialist centres were reported for most programs (7/8), and comprised multidisciplinary team members, including physicians, nurses, nurse practitioners, clinical nurse specialists, pharmacists, social workers, and psychologists [9,18,21,23,24,25,26]. Nurse coordinator roles were implemented to facilitate shared-care and were responsible for program leadership and patient care coordination [24,25]. Community hospital staff were described as either hematologists/oncologists or community oncologists, or those with experience in managing cytopenias, chemotherapy administration, and central venous catheter care [9,18,21,23,24,25,26]. The level of staff expertise within specialist centres was less defined; however, it was described as physicians with a specialty or subspecialty in acute leukemia [23], and those with experience caring for acutely ill CMH patients [21].
+
+Several articles reported that managing CMH patients in the community setting requires familiarity with disease-specific complications, and that establishing expertise requires time, education, and resources [18,26]. This is especially challenging when CMH patient volumes may be low [26]. It was identified that a trained, dedicated multidisciplinary team would support clinical competency, including the education of external team members such as emergency room staff [24,25,26]. Additional strategies to support the up-skilling of staff included treatment guidelines and algorithms [9,18], 24/7 live support via telephone or email for physician-physician consultation [9,18,24,26], and regular conferences and workshops to review protocols and provide updates on new treatments [9,26].
+
+3.4. Implementation
+
+The implementation of a program considers the degree to which the intervention is delivered as intended [10]. None of the articles reported on the duration of time individual patients were managed through shared-care. One program (1/8) reported the length of time patients were enrolled in shared-care, and the number of contacts with shared-care patients: a median of 3.5 in-person visits to the specialist centre over a median of 357 days of shared-care [23]. The rationale for program discontinuation for patients was not described [23]. Hershenfeld et al. [9] reported the total number of cycles of therapy that were given within the shared-care model (n = 137 cycles); however, no details were provided on length of time patients were followed on shared-care.
+
+While formal evaluations of fidelity were not reported, patient care was described as following pre-planned shared-care protocols (8/8). These protocols helped to ensure patients were managed in the most appropriate setting based on their medical needs over the course of treatment, while maintaining collaboration between the participating centres. In most cases, patients were admitted to the specialist centre for intensive therapy or the management of severe or infectious complications, while transferred to local community hospitals for low-dose chemotherapy and less medically intensive supportive care [9,21,22,23,24,25,26]. In some shared-care programs, community care was complemented with intermittent virtual care visits [21,23], or periodic in-person visits to the specialist centre [9]. The costs of implementing CMH shared-care were not reported for any of the programs (0/8).
+
+Various implementation strategies were used to support shared-care delivery as intended. Slater et al. [24] created a governing network to provide oversight for their model, inform care delivery, oversee quality improvement initiatives, and support research and education at specialist centres and community hospitals. Additional strategies included patient evaluation tools [25], joint electronic medical records [23,24], daily patient care discussions [18], dedicated treatment areas for immune-compromised patients [24], and patient education about community hospital and specialist centre responsibilities [9,24,25,26]. Challenges included a lack of available resources to provide the required care in the community [18], long wait times associated with patient transfer between centres [18], and the lack of available beds in specialized centres when hospitalization was necessary [18]. Possible solutions were proposed, such as the establishment of consultation services at both sites, including transfusion medicine and blood bank support, infectious diseases, and critical care [18,21], and ‘backup’ patient transfer service availability for community hospitals [22].
+
+3.5. Maintenance
+
+The maintenance of a program considers the measurement of the sustainability of an intervention [10]. Maintenance indicators (outcomes > 6 months post-intervention, indicators of program maintenance, or measures of cost of maintenance) were not reported for any of the programs (0/8).
+
+4. Discussion
+
+In this integrative review, the RE-AIM framework was used to evaluate what is known about the implementation of CMH shared-care. Eight programs, described across ten articles, were included in this review. Indicators of reach were reported for 65% of the programs, and emphasized standardized referrals and some eligibility criteria; however, patient participation rate and methods for identifying eligible patients were lacking. Effectiveness indicators were reported for 28% of programs, and suggested favourable survival outcomes within a shared-care model; however, health system impact and quality of life studies were lacking. Indicators of adoption and implementation were reported for 56% and 42% of programs, respectively, and emphasized program components of a multidisciplinary team, relationship-building, pre-planned protocols for managing patients at each site, infrastructure support, and various communication strategies such as shared electronic health systems. Measures of cost and maintenance were not reported.
+
+Because the methods for identifying patients were limited to specialist centre selection, there is a lack of understanding of who might benefit from shared-care, from the community hospital perspective. Known clinician-related referral barriers include knowledge gaps in relation to eligibility for various therapies, as well as a lack of established referral criteria [27,28]. Subjective interpretation of fitness for therapy, including age, comorbidities, and functional status, may impact patient referral. Some patients may not be offered evidence-based therapies if methods to identify patients have not been well established. As identified by our review, establishing referral criteria and networking between hospital sites may be an effective strategy for patient identification.
+
+The rate of patient participation was also poorly reported, limiting our understanding of the reasons that eligible patients may or may not receive shared-care. Known patient-related referral barriers to a specialist centre include hesitancy for specific treatment, travel burdens, financial challenges, or lack of caregiver support [5,27,28]. There may be additional factors that influence patient decision-making related to the site of care. Further research to better understand participation rate and strategies to target patient-related referral barriers may help with program recruitment and retention among eligible patients.
+
+Despite common patient eligibility criteria for CMH shared-care across programs (e.g., treatment subtypes), important details were lacking, providing little information about the ideal patient for shared-care. For example, the presence of opportunistic infections, requiring consultation with specialized infectious disease experts, may be important to consider when determining eligibility for shared-care. Criteria for treating CMH patients in the outpatient setting have been established to minimize the risk of treatment-related mortality, suggesting that a similar model can be instituted for shared-care. For example, Mabrey et al. [29] defined eligibility for outpatient management of AML patients as having adequate cardiac function, normal chest imaging, low disease burden, residing within 30 min of the hospital, and dedicated caregiver support. Research to determine the most appropriate eligibility criteria for shared-care will be important to optimize the safety and potential benefits of these programs.
+
+CMH patients treated at specialist centres have improved survival outcomes compared to patients treated in community hospitals [30,31]. This may be attributed to increased resources, staff expertise, and availability of evidence-based therapies at the specialist centre [32,33]. In our review, those who studied the effect of CMH shared-care compared to patients treated entirely at a specialized centre or community hospital, found improved or comparable survival outcomes, suggesting this model may be an effective strategy for improving access to care. Future studies should have larger sample sizes and reduced risk of selection bias, to verify these findings. Measurement of quality of life would provide a better sense of the impact of CMH shared-care on patients’ perceptions of physical, emotional, and social health. Travel time can be burdensome for patients; however, patients prefer quality specialist care, and they are more likely to choose therapy at specialized centres if follow-up and supportive care are shared locally with community hospitals [34,35]. Further research from the patient’s perspective would help inform an understanding of whether shared-care programs effectively improve quality of life.
+
+Across programs, the characteristics of the specialist centre were well-described; however, few programs reported on the characteristics of the community hospitals, limiting our understanding of the infrastructure that would support a shared-care model. Community hospitals and specialist centres have varying levels of service provision [36], and it is unclear from the literature what infrastructure is essential to consider. Ontario Health [36] has developed organizational requirements for providing acute leukemia care, which include the availability of private rooms for isolation, and outpatient assessment areas that can reasonably protect patients from transmission of infectious agents. Inclusion and exclusion criteria such as this would help decision-makers assess their organization’s readiness and advocate for the necessary resources to participate in shared-care.
+
+Our review emphasized the challenge of maintaining staff expertise in the community setting, where CMH patient volumes might be low. Staff and program leadership are responsible for ensuring clinicians demonstrate competency in prescribing, monitoring, and managing the complications of various therapies. From our review, facilitators included a trained and multidisciplinary team of providers, regular educational opportunities, and access to timely expert clinical advice. Strategies, such as physician sub-specialization, could be explored, as this may facilitate confidence in clinical management for CMH patients [37]. Additionally, investigating alternate primary provider roles, such as nurse practitioners, may be valuable in providing continuity, increasing the level of staff expertise [38].
+
+Although implementation fidelity was not well reported, the literature highlighted important elements for incorporating shared-care programs into the health system. Resources such as consultation services, patient education, joint electronic health records, and virtual care were identified as important program components. For providing acute leukemia services, Ontario Health [36] has identified the need for 24 h access to irradiated blood products, medications needed for CMH patients (e.g., all-trans retinoic acid), and diagnostic services such as bronchoscopy. While this provides important considerations for CMH shared-care program planning, the literature lacks a complete evaluation of these components. Additionally, virtual care increases access to care in oncology, and improves patient satisfaction and health outcomes [39], but how virtual care can be used in the context of CMH shared-care is less known. Further research could explore the organizational resources required for shared-care, including how virtual care can be used effectively in this patient population.
+
+None of the articles included in our review reported on aspects of CMH shared-care maintenance, limiting our understanding of program sustainability and whether shared-care can be successfully integrated into health systems. Muir et al. [22] identified that certain funding models that split finances between the specialist centre and community hospital could be a potential barrier to implementation; allocated funds into the community may compromise the ability of specialist centres to maintain specialized staff and resources. However, Muir et al. [22] also indicated that shared-care reduced specialist centre volumes and workload, enabling clinicians to devote time to caring for more complex patients. Economic evaluation studies may help to understand the financial impacts that would result from the implementation of shared-care, and inform an understanding of the resources required for long-term program delivery. For example, Cohen et al. [7] reported a reduction in health resource utilization with the introduction of a shared-care model for children with chronic conditions.
+
+Limitations and Strengths
+
+There are limitations to this review. First, the search was conducted using a variety of synonymous terms for shared-care, such as co-management or hub-and-spoke; however, this terminology is not consistent throughout the literature, thus it is possible some articles reporting a CMH shared-care program were missed. Second, conference abstracts and the grey literature were excluded from the eligibility criteria, limiting our understanding of CMH shared-care’s full scope. Third, the lack of standard reporting of implementation in the CMH shared-care literature (e.g., according to StaRI [40] guidelines), decreases the ability to compare programs effectively. A key strength was using the RE-AIM data extraction tool, which ensured a comprehensive understanding of the reporting of indicators. All searches were conducted at the same time and there were no start date limitations.
+
+5. Conclusions
+
+As the CMH patient population grows and ages, the challenges of travel burdens persist, and specialist centres face ongoing capacity pressures, it is critical to explore shared-care models as a potential solution. In this integrative review, the RE-AIM framework provided a guide for evaluating what is known about CMH shared-care programs. Favourable survival outcomes within a shared-care model were emphasized, and important program components included a multidisciplinary team, relationship-building, and shared communication strategies. Further research is warranted on patient eligibility, rationale for participation, health system and quality of life outcomes, maintaining staff expertise, infrastructure support, virtual care, and measures of cost and sustainability.
+
+Acknowledgments
+
+Technical librarian support was graciously provided by Rouhi Fahelzad, BSc, MISt from Princess Margaret Cancer Centre, Toronto.
+
+Supplementary Materials
+
+The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/curroncol31090406/s1, S1. Search Strategies. S2. Reporting of RE-AIM Indicators.
+
+Author Contributions
+
+Conceptualization, S.M.N., D.C.M., M.P. and S.J.M.; methodology, S.M.N., D.C.M., M.P. and S.J.M.; formal analysis, S.M.N. and S.J.M.; data curation, S.M.N. and S.J.M.; writing—original draft preparation, S.M.N.; writing—review and editing, D.C.M., M.P. and S.J.M.; supervision, S.J.M. All authors have read and agreed to the published version of the manuscript.
+
+Institutional Review Board Statement
+
+Not applicable.
+
+Informed Consent Statement
+
+Not applicable.
+
+Data Availability Statement
+
+No new data were created or analyzed in this study. Data sharing is not applicable to this article.
+
+Conflicts of Interest
+
+The authors declare no conflicts of interest.
+
+Figure 1 Flow Diagram of Search Strategy.
+
+curroncol-31-00406-t001_Table 1 Table 1 Definitions of RE-AIM Dimensions.
+
+RE-AIM Dimension	Definition	Importance	
+Reach	Assesses the number, proportion, and representativeness of patients willing to participate in CMH shared-care [10]	Helps to determine who may be suitable for CMH shared-care, and provides information on the acceptability of the intervention from the patient’s perspective [15]	
+Effectiveness	Evaluates the impact of CMH shared-care on important outcomes (measures/results, quality of life, unintended consequences) [10]	Evaluates whether CMH shared-care outcomes were changed (positively or negatively) [15]	
+Adoption	Assesses the number, proportion, and representativeness of settings and staff who deliver CMH shared-care [10]	Helps to determine which settings are most suitable for CMH shared-care, and provides information on the approach to identify and engage staff for program delivery [15]	
+Implementation	Refers to intervention duration and frequency, the extent CMH shared-care was delivered as intended, measures of implementation cost [10]	Provides insight into the resources needed compared to the resources available, as well as the feasibility of delivering all components of CMH shared-care [15]	
+Maintenance	Evaluates the degree to which CMH shared-care is continued as part of organizational practices and policies [10]	Provides insight into whether the intervention can be integrated into health systems [15]	
+(CMH = complex malignant hematology).
+
+curroncol-31-00406-t002_Table 2 Table 2 Example of the Search Strategy used in Medline.
+
+Population	Complex malignant hematology terms
+
+leukemia (meSH) OR leuk?emi* OR lymphoma (meSH) OR lymphoma* OR myelodysplastic syndromes (meSH) OR myelodysplas* OR myelo-dysplas* OR myeloproliferative disorders (meSH) OR myeloprolif* OR myelo-prolifer* OR myelodysplastic-myeloproliferative diseases (meSH) OR multiple myeloma (meSH) OR myeloma OR hematologic neoplasms (meSH) OR hematopoietic stem cell transplantation (meSH) OR transplantation, autologous (meSH) OR (autologous AND transplant*) OR transplantation, homologous (meSH) OR ((homologous OR allogeneic) AND transplant*) OR receptors, chimeric antigen (meSH) OR immunotherapy, adoptive (meSH) OR (chimeric AND antigen AND receptor AND therapy) OR induction chemotherapy (meSH) OR consolidation chemotherapy (meSH) OR maintenance chemotherapy (meSH)	
+AND Intervention	Shared-care terms
+
+((share? OR sharing?) AND care) OR co-management OR (care AND coordination) OR hospital shared services (meSH) OR (hospital AND (shar? OR sharing?) AND service*) OR delivery of health care, integrated (meSH) OR (integrated adj3 healthcare) OR community networks (meSH) OR (community AND network*) OR (community and partner*) OR cooperative behavior (meSH) OR (hub AND spoke) OR (hospitals, community (meSH) OR hospitals, general (meSH) OR hospitals, low-volume (meSH) OR hospitals, rural (meSH) OR hospitals, centers (meSH)) AND (hospitals, teaching (meSH) OR hospitals, urban (meSH) OR tertiary care centers (meSH)) OR (hospitals, high-volume (meSH) OR cancer care facilities (meSH))	
+
+curroncol-31-00406-t003_Table 3 Table 3 Characteristics of Included Programs.
+
+Author (Year)	Study Location	Aim	Design	Participants	Description of Patient-Sharing Model	
+Cheung et al. (2021) [25]	Canada	To describe the shared-care model between specialized cancer centre and local hospital for patients with MPN	Discussion paper	Adult; MPN	Treatment decisions and some therapy at specialized centre; supportive care at local hospital (e.g., count checks, transfusion support)	
+Goradia et al. (2023) [23]	New York, USA	To describe a shared cancer care delivery model for patients with myeloid malignancies between academic leukemia centre and general community oncologists	Case series of patients	Adult, MDS and acute leukemia	Initial patient visit in person or via telehealth at specialist centre, and subsequent care delivered at community hospital.	
+Hershenfeld et al. (2017) [9]	Canada	To review the impact of shared-care model with specialized cancer centre and local hospitals with an emphasis on travel time and distance saved	Retrospective cohort study	Adult, AML	Patients receive post-consolidation supportive therapy at local hospital, while consolidation chemotherapy itself is administered at specialist centre	
+Jillella and Kota (2018) [20]
+
+Jillella et al. (2020) [19]
+
+Jillella et al. (2021) [18]	Georgia, USA	To describe a strategy of co-management by community oncologists and APL experts and implementation of standardized treatment algorithm to reduce early deaths in APL	Discussion paper (n = 2); Prospective cohort study (n = 1)	Adult, APL	Co-management between 4 large leukemia treatment centres and 15 local community hospitals, with a focus on physician education and support (via phone/email) for managing newly diagnosed APL in the community.	
+Law et al. (2021) [21]	California, USA	A pre- and post-implementation evaluation comparing patients from 2013/2014 (managed by community-based hematologists) to 2016/2017 after shared-care was implemented.	Retrospective cohort study	Adult, AML	Patient-sharing between regional leukemia centre and local centre; with focus on referrals, identifying and shifting less-intensive therapies to community	
+Lim et al. (2022) [26]	Singapore	To describe the development and implementation of a hub-and-spoke model of cross border patient-sharing collaboration for CAR-T therapy (Singapore as hub and East Asian countries as spoke centres)	Discussion paper	Adult, lymphoma	Patients receive standard therapy in home country, CAR-T in hub treatment centre, and then back to spoke country for post therapy monitoring	
+Muir et al. (1992) [22]	England, UK	To describe the survival of patients with acute lymphoblastic leukemia treated in shared-care model with regional hospitals	Nested case-control study	Pediatric, ALL	Children are referred to regional specialist centre for initial diagnosis and treatment; management of continuing treatment is carried out at regional hospital	
+Slater et al.
+(2022) [24]	Australia	To examine the role of regional case managers with patient sharing in tertiary centre and shared-care sites	Qualitative, phenomenological study	Pediatric, malignant hematology	Tertiary children’s hospital and network of 10 local shared-care sites. Shared-care sites provide low-risk chemotherapy and supportive care after diagnosis, care planning, and some treatment is performed at tertiary centre.	
+(CAR-T = chimeric antigen receptor therapy; MPN = myeloproliferative neoplasm; MDS = myelodysplastic syndrome; AML = acute myeloid leukemia; APL = acute promyelocytic leukemia; ALL = acute lymphoblastic leukemia).
+
+curroncol-31-00406-t004_Table 4 Table 4 Proportion of CMH Shared-Care Programs Reporting RE-AIM Dimensions and Indicators.
+
+RE-AIM Dimensions and Indicators	Frequency	Proportion	
+Reach: The number, proportion, and representativeness of patients willing to participate in CMH shared-care	
+Method to identify patients	6/8		
+Inclusion criteria	8/8		
+Exclusion criteria	2/8		
+Sample size and participation rate	5/8		
+Characteristics of both participation and non-participation	4/8		
+Average of overall reach dimension	26/40	65%	
+Effectiveness: The impact of CMH shared-care on important outcomes	
+Measures/results	6/8		
+Intent-to-treat analysis utilized	0/8		
+Quality of life outcomes	2/8		
+Percent attrition	1/8		
+Average of overall effectiveness dimension	9/32	28%	
+Adoption: The number, proportion, and representativeness of settings, and staff who deliver CMH shared-care	
+Description of intervention location	8/8		
+Description of staff who delivered intervention	7/8		
+Method to identify staff who delivered CMH shared-care	3/8		
+Level of staff expertise	7/8		
+Inclusion/exclusion criteria of shared-care setting	2/8		
+Adoption rate	0/8		
+Average of overall adoption dimension	27/48	56%	
+Implementation: Fidelity to various elements of CMH shared-care	
+Intervention duration and frequency	2/8		
+Extent shared-care delivered as intended	8/8		
+Measures of cost of implementation	0/8		
+Average of overall implementation dimension	10/24	42%	
+Maintenance: Extent to which CMH shared-care is maintained after intervention	
+Assessed outcomes >6 months post-intervention	0/8		
+Current status of program	0/8		
+Measures of cost of maintenance	0/8		
+Average of overall maintenance dimension	0/24	0%	
+
+curroncol-31-00406-t005_Table 5 Table 5 Programs Reporting Effectiveness.
+
+Author (Year)	Patients	Results	
+Hershenfeld et al. (2017) [9]	n = 417; 73 patients received shared-care vs. 344 patients treated only at specialist centre	No significant difference in survival between 2 groups (90 d survival = 95.9% vs. 95.3%).
+No significantly increased hazard of death found for shared-care group.	
+Jillella et al. (2021) [18]	n = 118 (73 shared-care patients vs. 45 treated only at specialist centre)	No difference in induction mortality between 2 groups of patients (8.2% in shared-care vs. 8.8% at specialist centre alone) and no difference in 1-year survival.
+
+Overall 1-year survival rate for whole group was 87.3% (superior in comparison to 70.7% reported in SEER data)	
+Law et al. (2021) [21]	n = 249 (135 shared-care and 114 treated at community hospital alone) in 2016/2017
+
+vs.
+
+n = 278 treated at community hospital alone in 2013/2014	More patients received induction therapy (intensive and less-intensive inductions) with implementation of regionalization (65.2% vs. 49%).
+
+Observed reductions in 60 d (HR = 0.67) and 180 d mortality (HR = 0.64) in comparison to time period prior to shared-care implementation.	
+Muir et al. (1992) [22]	n = 146 (49 shared-care vs. 97 treated at specialist centre alone)	When age-matched with comparison group, the 49 patients included in shared-care model had survival rates comparable to those treated entirely at specialist centre *.	
+* The paper illustrated a survival curve; however, exact percentages were not included.
+
+Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.
+
+
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+JOURNAL INFORMATION
+==============================
+NLM Title Abbreviation: Glob Health Action
+Journal ID: Glob Health Action
+NLM Journal ID: 101496665
+
+Global Health Action
+
+ISSN: 1654-9716
+EISSN: 1654-9880
+Publisher: Taylor & Francis
+
+ARTICLE INFORMATION
+==============================
+PMCID: PMC13021022
+PMID: 41879796
+DOI: 10.1080/16549716.2026.2647528
+Article ID: 2647528
+Article version: 1
+Article version: Version of Record
+Subjects: Review Article, Review Article
+
+Determinants of private health insurance uptake and its association with healthcare utilization in Gulf Cooperation Council countries: a systematic review
+
+K. S. ALTHABAITI ET AL.
+
+GLOBAL HEALTH ACTION
+
+https://orcid.org/0009-0007-7401-6573 Althabaiti Khaled Shaeel a b Conceptualization Data curation Formal analysis Methodology Validation Writing – original draft Writing – review & editing
+https://orcid.org/0000-0002-0293-8612 Bhuiyan Mohammad Badrul c Data curation Formal analysis Validation Writing – original draft Writing – review & editing
+https://orcid.org/0000-0003-1779-1286 Hunsberger Monica a Supervision Validation Writing – original draft Writing – review & editing
+https://orcid.org/0000-0001-9499-1500 Ahmed Sayem d Supervision Writing – original draft Writing – review & editing
+https://orcid.org/0009-0000-2612-9783 Khan Jahangir a c e Conceptualization Supervision Validation Writing – original draft Writing – review & editing
+a School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
+b Basic Nursing Sciences Department, College of Nursing, Taif University , Taif , Saudi Arabia
+c Department of International Public Health, Liverpool School of Tropical Medicine , Liverpool , UK
+d Health Economics Research Group (HERG), Department of Health Sciences, Brunel University London , Uxbridge, London , UK
+e Department of Learning, Informatics, Management and Ethics, Karolinska Institutet , Stockholm , Sweden
+CONTACT Khaled Shaeel Althabaiti Khaled.althabaiti@gu.se School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Medicinaregatan 18A, Gothenburg 413 90, Sweden
+Electronic publication date: 2026 Mar 25
+Publication date: 2026
+Volume: 19
+Issue: 1
+Electronic Location ID: 2647528
+Copyright: © 2026 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
+Copyright year: 2026
+Copyright holder: The Author(s)
+License: This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.
+License URL: https://creativecommons.org/licenses/by/4.0/
+
+Keywords: Determinants, Gulf Cooperation Council, private health insurance, healthcare utilization, insurance
+
+Support: Taif University, Kingdom of Saudi Arabia This study was supported by a doctoral scholarship from Taif University, Kingdom of Saudi Arabia. No additional funding or benefits were received for conducting this study.
+
+Figure count: 4
+Table count: 4
+Reference count: 57
+Page count: 1
+
+Responsible editor Jennifer Stewart Williams
+
+Ÿ==============================Ÿ
+ABSTRACT
+
+All Gulf Cooperation Council (GCC) countries have a multi-payer healthcare system that comprises governmental health coverage (GHC), funded by the government, and private health insurance (PHI), mainly sponsored by employers and purchased by individuals. Both are expected to influence healthcare utilization and contribute to system efficiency and patient well-being. This systematic review explored the determinants of PHI uptake and its association with healthcare service utilization in the presence of GHC in GCC countries. We systematically searched CINAHL, PubMed, Scopus, Web of Science, and Cochrane Library for peer-reviewed studies published between January 2012 and October 2022. Study quality was assessed using the Critical Appraisal Skills Programme (CASP) checklists for both quantitative and qualitative studies, following PRISMA guidelines. Twenty-six studies met the inclusion criteria. Determinants of PHI uptake were mapped to Andersen’s Behavioral Model of Health Services Use (BMHSU) and categorized into (1) predisposing factors (sex, age, marital status, and education), (2) enabling factors (employment/income and health system-related factors such as access and perceived service quality), and (3) need factors (health status, including chronic noncommunicable diseases). PHI uptake was positively associated with being male, married, highly educated, employed with a high income, and having chronic diseases. PHI was positively associated with healthcare utilization, particularly routine check-ups, preventive services, and the use of prescribed medicines. In GCC countries, PHI uptake is influenced by sociodemographic and socioeconomic characteristics, health status, and perceived service quality. PHI is also associated with higher healthcare utilization, underlining the need for evidence-informed policies that enhance equity and expand coverage.
+
+PAPER CONTEXT
+
+Main finding: Private health insurance uptake across Gulf Cooperation Council countries was influenced by sociodemographic and socioeconomic characteristics, health status, and the quality of services. Additionally, private health insurance was likely to be associated with higher utilization of healthcare services.
+
+Added knowledge: This systematic review identifies how shifts in health policy across Gulf Cooperation Council countries, particularly the move from universal public coverage toward mixed systems combining governmental and mandatory private insurance which have redefined the determinants of private health insurance enrollment and healthcare utilization. It highlights how socioeconomic characteristics and policy reforms interact to shape access patterns under differing insurance schemes.
+
+Global health impact: The findings can support policymakers in developing equitable and sustainable health financing reforms toward universal health coverage.
+
+Background
+
+The Gulf Cooperation Council (GCC) comprises six countries: Kuwait, Bahrain, the United Arab Emirates (UAE), the Kingdom of Saudi Arabia (KSA), Qatar, and Oman. These countries have similar financial situations, such as dependence on vast reserves of oil and gas [1]. In recent decades, these countries have experienced considerable population growth, partly due to increases in expatriate populations [2]. The percentage of expatriates in these countries ranges between 33.3% in Oman and 86.2% in Qatar [3]. In the past few decades, healthcare investments in GCC countries have increased through the expansion of healthcare facilities, including large medical complexes and medical cities [4]. According to recent estimates in 2019, the GCC member countries spent on average 4.6% of their gross domestic product (GDP) on healthcare expenditure, ranging from as low as 3.5% (Qatar) to as high as 6.1% (KSA) [5].
+
+However, the increasing demand for health services puts a significant burden on the health system in GCC countries, and thus, there is a need for substantial changes in the strategies and infrastructure of the healthcare system to overcome these challenges [6]. In response to financial hardship, governments in GCC countries have implemented reforms to expand health coverage for their populations and improve access to healthcare by adopting private health insurance (PHI) schemes in addition to governmental health coverage (GHC), with the broader aim of achieving universal health coverage (UHC) [7]. Accordingly, it has been reported that there are approximately 214 PHI companies in GCC countries; 90 of these companies have a major market share (80% of the total premium collected), while the other 114 companies compete for the remaining 20% of the market share [8]. The GCC countries have similar policies for governing many aspects of healthcare services and health insurance [9]. It should be noted that all GCC countries have a multipayer health financing system, comprising GHC, which the government fully funds, and PHI, either sponsored by employers or purchased by individuals [10].
+
+As of 2022, non-citizens accounted for 54.6% of the total population across GCC countries, compared with 47.8% in 2000, with their share exceeding 85% in Qatar and the UAE. This reflects a demographic transformation that has steadily intensified over the past two decades, driven by sustained labor migration, and now carries significant implications for healthcare financing and equity [11,12].
+
+Fadhil et al. (2022) argued that extending mandatory PHI to low-income expatriates in GCC countries may enhance health equity. In addition to this equity goal, the policy also aimed to reduce the financial burden on governments by shifting healthcare costs primarily to employers, with a smaller share borne by individuals. Nevertheless, this approach may place additional financial and operational pressure on the healthcare system [6]. This pressure may stem from increased service demand without a proportional investment in infrastructure, especially when some individuals with PHI lack sufficient understanding, which can lead to inappropriate use, including unnecessary visits that strain resources and reduce system efficiency [6,13]. Ram (2014) added that achieving healthcare targets in the GCC countries will depend on responding to new challenges, such as health insurance coverage, insufficient medical practitioners, and a lack of stringent guidelines on quality standards [14]. Similarly, Alshamsan et al. (2017) stated that the path to a universal insurance scheme in the GCC countries would face challenges, such as an increasing number of non-national residents, which highlights the need for inclusive and sustainable policy solutions [9].
+
+Under the GHC in KSA, public health facilities offer free healthcare services to Saudi citizens and expatriates working in various governmental sectors (Ministry of Health and Ministry of Education) [15]. To reduce the financial burden on the government, KSA introduced the Cooperative Health Insurance Law, which mandates employers to provide private insurance coverage for all workers (both Saudi and non-Saudi) in the private sector [16]. This strategy aimed to overcome the challenge of providing free healthcare services to the residents in the country, which has been achieved through 27 insurance companies offering medical coverage to more than 11 million people [17]. The regulations and laws for PHI issued by the Saudi Council of Health Insurance (CHI) outline how healthcare services are financed. Responsibilities are shared between employers (who pay premiums), employees (who make co-payments), beneficiaries (who must understand how to access care), and insurance companies (which manage coverage and claims) [16].
+
+In Kuwait, citizens receive free healthcare services at public health facilities, whereas foreigners are required to pay a compulsory annual health fee to access medical treatment at these facilities. However, the costs of services provided by private healthcare providers are not covered under this requirement. Renewal of a residence permit for expatriates requires payment of the health fee by their employer. Even when individuals have paid the annual health fee, they may still have to pay for certain services provided by public facilities [18].
+
+In Bahrain, the healthcare system depends on both public and private healthcare providers to deliver primary care services. Bahraini nationals are covered under the National Social Health Insurance Program (Sehati), which entitles them to free services at public healthcare facilities funded by the government. Non-Bahraini residents are charged a small fee to receive healthcare services at government facilities; however, Sehati also extends cost-free coverage to specific expatriate groups, such as domestic workers (e.g. drivers and gardeners) sponsored by their employers. Other expatriates working in the private sector must be covered through employer-sponsored PHI [19].
+
+Oman provides free GHC to all Omani citizens through the Ministry of Health. In addition, Oman has introduced a compulsory PHI scheme named ‘Dhamani’, which provides coverage for more than 2 million individuals. The program includes individuals working in the private sector, expatriates, and international visitors. The responsibility of employers is as follows: Dhamani mandates that employers cover the cost of health insurance premiums for their employees. The program ensures essential health coverage, including hospitalization, emergency care, treatment for common illnesses that affect work performance, and medications prescribed by certified doctors. Employers have the option to provide extra benefits such as maternity, infant health, dental, and vision care [20].
+
+Qatar provides publicly funded healthcare to all residents through the Hamad Medical Corporation. Qatari citizens receive free healthcare services under the GHC system. For migrant workers, there are two strategies to improve healthcare access, and all expatriates must be covered by one of these strategies to obtain or renew their residency. The first is the Hamad Health Card, which grants residents, including migrant workers and their families, access to public healthcare facilities. Under this program, migrants pay minimal fees for the medical treatment they receive. The second is employer-sponsored PHI, which may be advantageous for skilled migrants, as it offers PHI plans provided by employers that provide international coverage [21].
+
+In the United Arab Emirates (UAE), citizens receive free healthcare at health facilities under the GHC system, while expatriates are required to have PHI to access healthcare, which is mandatory for obtaining residency. In contrast, citizens can utilize certain private healthcare facilities covered by GHC. The Emirates of Dubai and Abu Dhabi have each established unified GHC programs, ‘Enaya’ for Dubai citizens and the ‘Thiqa’ program for Abu Dhabi citizens, thus providing access to high-quality medical services and better healthcare through an advanced integrated system, according to a press release [22].
+
+Although the GCC countries have similar policies for governing many aspects of healthcare services and insurance, differences in implementation create a valuable opportunity to widen knowledge about the factors associated with the uptake of PHI and its impact on the utilization of health services [9]. Furthermore, due to the recent introduction and adoption of PHI in GCC countries, it is necessary to evaluate its implementation, influencing factors, and effects on healthcare utilization. Such research could help policymakers shape the future of the health system in the GCC countries. Therefore, the current study aims to explore the determinants of PHI uptake in GCC countries and its association with the utilization of health services.
+
+The study aims to answer two specific questions: What are the determinants of PHI uptake in GCC countries?
+
+What is the association between PHI and healthcare utilization in GCC countries?
+
+Methods
+
+Two reviewers searched the following electronic databases and search platforms: CINAHL, PubMed, Scopus, Web of Science, and Cochrane Library to identify relevant English-language studies published between 1 January 2012 and 31 October 2022. To ensure a broad range of relevant studies, we used a combination of health insurance-related Medical Subject Headings (MeSH) terms and text words (ti, ab, kw) to search the databases. Our study primarily focuses on private health insurance (PHI). To ensure comprehensive coverage, we included all MeSH and text terms related to health insurance, which allowed us to capture studies where PHI status was discussed either directly or indirectly (e.g. through out-of-pocket spending or willingness to pay). Although the search strategy included the generic term ‘health insurance,’ we operationalized eligibility as PHI and confirmed the coverage type during full-text screening. Studies were classified as PHI only when the described health insurance was private/employer-based, the typical form of insurance in GCC settings. This interpretation is consistent across the literature, particularly when referring to insurance coverage among expatriates or workers in the private sector, where PHI is the predominant form of insurance. This understanding was carefully verified during the full-text screening stage. The following search strategy was used: (‘insurance, health’[MeSH Terms]) OR (health insurance*[tiab]) OR (‘insured’[Title/Abstract]) OR (‘uninsured’[Title/Abstract]) OR (‘community insurance’[Title/Abstract]) OR (‘medical insurance’[Title/Abstract])) OR (‘universal healthcare’[Title/Abstract])) AND (GCC) OR (Gulf Cooperation Council) OR (Bahrain*) OR (Saudi) OR (KSA) OR (Kuwait*) OR (Oman*) OR (Qatar*) OR (UAE) OR (United Arab Emirates) OR (emirate) AND ((‘2012’[Date – Publication]: ‘2022’[Date – Publication])) The search process complied with PRISMA guidelines. The study protocol was approved by PROSPERO (Protocol ID: CRD42022373179).
+
+Eligibility criteria
+
+We applied predefined eligibility criteria to identify peer-reviewed studies examining PHI uptake and its association with healthcare utilization in GCC countries. The inclusion criteria and reasons for exclusion used during screening are summarized below.
+
+Inclusion criteria
+
+Time frame: 1 January 2012 to 31 October 2022.
+
+Language: English; full text available.
+
+Participants: Adults; studies assessing PHI status (enrolled vs. not enrolled) and/or comparing PHI with other coverage groups.
+
+Place/Setting: GCC countries (Saudi Arabia, UAE, Qatar, Oman, Kuwait, Bahrain).
+
+Type of source: Peer-reviewed original research articles.
+
+Quality appraisal: Included studies were required to meet a minimum methodological quality threshold based on CASP (≥50%).
+
+Studies addressing: (1) determinants of PHI uptake and/or (2) association between PHI and healthcare utilization.
+
+Reasons for exclusion criteria
+
+Outside time frame.
+
+Non-English and/or full text not accessible.
+
+Non-adult population and PHI not examined.
+
+Studies conducted outside the GCC; multi-country studies with no separate GCC results.
+
+Gray literature or non-original publications (e.g. conference abstracts/proceedings, theses/dissertations, books, and policy/NGO).
+
+Studies were excluded if they did not meet the minimum methodological quality threshold (CASP score <50%); however, no studies were excluded on this basis.
+
+Studies that do not report outcomes relevant to PHI uptake or healthcare utilization.
+
+Types of studies
+
+All studies including qualitative, quantitative, or mixed-methods analyses were considered to be eligible for this review.
+
+Conditions or domains that have been studied
+
+Private health insurance uptake and healthcare utilization.
+
+Selection of studies
+
+The first reviewer, Khaled Althabaiti (KA), conducted the database search for relevant articles, using the pre-set search terms, which were refined based on training received in the university course ‘Systematic Reviews and Meta-analysis – SM00099’ at the University of Gothenburg. The second reviewer, Mohammad Badrul Bhuiyan (MBB), used the same search terms strategy. Both reviewers used Rayyan software for independent screening of the selected studies, following the inclusion and exclusion criteria for eligibility of the articles to be included in the review. The initial screening items included checking the titles and abstracts for relevance. The full texts of all included articles were then examined in parallel and separately by the two reviewers to determine whether they met all inclusion and exclusion criteria. Any disagreements between reviewers were discussed and resolved through dialogue. We had planned that if we faced any conflict, we would involve a third, independent reviewer to consult on the final decision. However, there was no conflict between the two primary reviewers. The full search strategy is provided in Supplementary Table S1, including the databases searched, the search terms used, the filters applied, the search period, and the initial number of studies identified. A total of 26 studies met the eligibility criteria and were included in the final review. A PRISMA flow diagram illustrating the study selection process is presented in Figure 3.
+
+Data extraction
+
+Two reviewers (KA and MBB) independently extracted data into an Excel sheet. The following data were extracted for each study: title, year of publication, study aim, country studied, income category of that country, study design, data sources, and data collection methods, main findings of the study, any additional findings, conclusion, and study limitations. To ensure consistency, accuracy, and minimize bias in study selection, a third independent reviewer was involved in resolving any disagreements between the two primary reviewers regarding eligibility criteria. However, there was no conflict between the two primary reviewers. The details for each study are provided in Supplementary Table S2.
+
+Quality assessment and Risk of bias assessment
+
+We used the Critical Appraisal Skills Programme (CASP) checklists for both quantitative and qualitative studies, an effective tool for appraising the strengths and limitations of research designs [23]. The CASP checklist for quantitative studies provides a structured approach to assess the validity, outcomes, and relevance of quantitative studies. The checklist consists of 11 elements covering three main domains: (1) validity: This evaluates the study’s design and methods. Essential inquiries involve whether the research addressed a specific problem, whether the cohort was selected correctly to reduce bias, and whether the exposure and results were accurately measured. It is also essential to ascertain whether confounding factors were managed through approaches, such as stratification. (2) Outcomes: This segment evaluates the precision and dependability of results. Important factors include how the main findings are presented (e.g. risk ratios, odds ratios) and the accuracy of these findings as indicated by p-values, confidence intervals, and sample size. (3) Applicability: This section assesses the significance of outcomes for local situations. It evaluates whether the findings are trustworthy, relevant to local communities, and in agreement with other studies. The potential effects on clinical or public health practices should be evaluated to understand how the findings influence practical applications in the real world. Meanwhile, the checklist for the qualitative study included 10 elements that evaluated the design, research aims, methodology, recruitment, appropriateness of data collection, researcher–participant relationship, ethical considerations, data analysis, outcome, and value of the research.
+
+According to the assessment of each element, studies were rated as ‘Yes’ when the suggested requirement was fulfilled (score = 2), ‘Can’t tell’ when it was partially fulfilled (score = 1), or ‘No’ when it was absent or seriously deficient (score = 0). The CASP checklists were used to appraise and describe the methodological quality of the included studies. The CASP cross-sectional checklist was applied to 25 quantitative observational studies, while the CASP qualitative checklist was used for one qualitative study. Overall item-level CASP ratings across the included quantitative studies and the qualitative study are summarized in Figures 1 and 2. A pragmatic threshold of ≥50% (based on the total CASP score) was pre-specified by the review team to define eligibility; however, no studies were excluded because all included studies met this threshold. Detailed appraisal results for each study are presented in Supplementary Tables S3 (qualitative) and S4 (quantitative). Figure 1. CASP item-level assessments across quantitative studies (n = 25).
+
+A bar graph showing CASP item-level appraisal across quantitative studies.
+
+Figure 2. CASP item-level assessments for the included qualitative study (n = 1).
+
+A bar graph showing CASP item-level appraisal results for a qualitative study.
+
+Results
+
+In total, 559 articles were identified from the CINAHL (n = 108), PubMed (n = 303), Scopus (n = 27), Web of Science (n = 113), and Cochrane Library (n = 8) databases (Figure 3). After removing duplicates (n = 170), the titles and abstracts of the remaining 389 articles were screened based on the inclusion and exclusion criteria. A total of 355 articles were excluded in the first stage, and 8 more articles were excluded due to a lack of full text. Overall, 26 articles were identified as eligible for this systematic review. Figure 3. The PRISMA flow chart of the study selection process.
+
+A PRISMA flowchart of study selection process with steps from identification to inclusion.
+
+General characteristics of the selected studies
+
+Twenty-four of the 26 included articles used a cross-sectional design; one study was prospective, and one was retrospective. In total, 16 studies used primary data, and 10 used secondary data. Most studies were conducted in Saudi Arabia (n = 19), followed by the United Arab Emirates (n = 4) and Qatar (n = 2). One study examined GCC countries as a whole. Eleven articles investigated the determinants of PHI uptake, and 15 assessed the association between PHI and health service utilization (Table 1).Table 1. Characteristics of the selected studies.
+
+Characteristics	Frequency (%)	
+Study design	 	
+Cross-sectional	24 (92.4)	
+Prospective study	1 (3.8)	
+Retrospective study	1 (3.8)	
+Source of data	 	
+Primary	16 (61.5)	
+Secondary	10 (38.5)	
+Impact outcome	 	
+Determinants of PHI uptake	11 (42.3)	
+Association between PHI and healthcare utilization	15 (57.7)	
+Study setting country	 	
+All GCC countries	1 (3.8)	
+Saudi Arabia	19 (73.1)	
+United Arab Emirates	4 (15.4)	
+Qatar	2 (7.7)	
+Percentages are calculated based on the total number of included studies (N = 26).
+
+Determinants of private health insurance uptake in GCC countries
+
+Willingness to pay was used as a proxy for demand for health insurance to explore potential determinants of interest in obtaining PHI in Saudi Arabia; it was measured as a binary (yes/no) response and reported as the proportion of participants willing to pay. Al-Hanawi et al. (2018) revealed that the proportion of participants reporting willingness to pay was influenced by household size, education, income, and satisfaction with public healthcare services [24]. Additionally, other studies showed that willingness to pay for PHI was higher among males, employed and married individuals, and those with chronic diseases [25], and older people [26]. Moreover, two of the included studies examined the quality of services; in Saudi Arabia, respondents were willing to pay for PHI to obtain higher quality services [25,27].
+
+In Saudi Arabia, the proportion willing to pay for PHI among government school workers was found to be significantly higher among males, those with higher education levels and those diagnosed with chronic diseases [28]. In another study that explored the factors associated with PHI among expatriates, it was found that both personal and workplace characteristics are important factors that increase the likelihood of being an individual with PHI; these factors include being married and having a technical job that requires a high school level of education [29]. Studies in KSA showed that the proportion willing to pay for health insurance ranged from 62.9% to 77.9% [24–28], as summarized in Figure 4. Figure 4. Proportion willing to pay for private health insurance: summary of included studies.
+
+A bar graph showing the proportion willing to pay for private health insurance across different studies.
+
+In KSA, the out-of-pocket (OOP) expenditure on chronic diseases was significantly higher among patients with PHI than among patients without PHI. This was partially explained by the notion that individuals often choose to purchase PHI based on their health-associated risks and their expectations of needing frequent health services [30]. In the same context, another study found that OOP expenditure was significantly higher among privately insured patients with an increased number of chronic diseases [31]. In another study in KSA, the decomposition of inequality in out-of-pocket health expenditures showed that the contributions of various socioeconomic factors to inequality were heterogeneously distributed between rich and poor individuals, such that OOP expenditures were generally higher among rich individuals than among poor individuals [15]. In another study covering all GCC countries, it was found that a considerable proportion of individuals without PHI had to borrow money to cover the costs of medical services [9]. In the United Arab Emirates, 79% of the randomly selected type 2 diabetic patients (T2DM) attending government hospitals had PHI, which indicated that having a chronic disease necessitating frequent visits to healthcare facilities encouraged patients to purchase PHI [32].
+
+In summary, determinants of PHI uptake were mapped to Andersen’s Behavioral Model of Health Services Use (BMHSU) and categorized into three domains: (1) predisposing factors (e.g. sex, age, marital status, education), (2) enabling factors (e.g. employment/income and health system-related factors, such as access to services and perceived service quality), and (3) need factors (e.g. health status, including chronic conditions). These findings are summarized in Table 2, which presents the specific determinants identified across the included studies.Table 2. Summary of studies on the determinants of private health insurance uptake in GCC countries.
+
+Study	Country	Design	Sample size	Population	Determinants of uptake	
+Al-Hanawi et al. 2018	Saudi Arabia	Cross-sectional	1187	Saudi heads of household in Jeddah province	Smaller household size, higher education level, higher income, and satisfaction with healthcare services.	
+Al Mustanyir, Turner, and Mulcahy 2022	Saudi Arabia	Cross-sectional	600	General adult population in Riyadh	Gender, employment status, marital status, and having a chronic disease, and improvement of services	
+Alharbi 2021	Saudi Arabia	Cross-sectional	622	School workers	Higher education, chronic disease, and age	
+Al-Hanawi, Alsharqi, and Vaidya 2020	Saudi Arabia	Cross-sectional	1187	Heads of household in Jeddah Province	Conditional with improvement of services	
+(Alkhamis et al. 2017)	Saudi Arabia	Cross-sectional	4575	Male expatriate employees in the private sector (Riyadh)	Being married, occupying technical jobs, and having a higher level of education.	
+Almalki, Alahmari, Alqahtani, et al. 2022a	Saudi Arabia	Cross-sectional	1255	Households in Riyadh with members diagnosed with chronic NCDs	Chronic Non-Communicable Diseases	
+Almalki, Alahmari, Alqahtani, et al. 2022b	Saudi Arabia	Cross-sectional	1176	Households in Riyadh that used healthcare at least once in the past 3 months	Chronic Non-Communicable Diseases	
+Al-Hanawi, Mwale & Qattan, 2021	Saudi Arabia	Cross-sectional	8655	General population	Non-Saudi nationality, older age, male sex, married status, higher education, good self-rated health, and wealthier.	
+Alshamsan et al. 2017	GCC countries	Cross-sectional	3998	General population	Economic status	
+Radwan et al. 2020	United Arab Emirates	Cross-sectional	244	Diabetic patients	Chronic disease	
+Alharbi 2022	Saudi Arabia	Cross-sectional	475	General adult population in Saudi Arabia	Having a higher level of education and age	
+
+Exploring the association between private health insurance and healthcare utilization in GCC countries
+
+In KSA, nationally representative data were obtained from the Saudi Family Health Surveys (SFHS), and two studies were carried out. The first study revealed that PHI was positively associated with the likelihood of undergoing medical check-ups by 17%, compared with individuals without PHI. More specifically, there was a 13% increase in medical check-ups among citizens and a 20% increase among expatriates with PHI. These findings indicate that PHI encourages individuals to seek medical check-ups, even among citizens who have the privilege of using free services under the GHC [33]. The second study showed that individuals with PHI were more than twice as likely to seek periodic preventive health check-ups compared with those without PHI (OR = 2.29; 95% CI = 2.02–2.59; p ≤ 0.01) [17].
+
+However, PHI did not necessarily increase the utilization of all healthcare facilities. Alsubaie et al. (2016), in a study conducted in KSA, concluded that the use of public primary healthcare at tertiary hospitals was much less common among individuals with PHI than among those without PHI. This was explained by the preference of individuals with PHI and with higher income to choose private health services over public facilities [34].
+
+In the UAE, T2DM patients with PHI were two times more likely to use complementary and alternative medicine (CAM) than patients without PHI (OR: 2.08; CI: 1.11–3.86). Researchers argued that PHI by itself was not a direct predictor of CAM use, but this association could be explained by the fact that PHI holders, especially when employed, would have sufficient income to afford the OOP costs of CAM services [32].
+
+Another study in the UAE highlighted that healthcare utilization under PHI varied by occupational class. The introduction of a single-payment system generated accurate data, which revealed discrepancies in the utilization of health services [35]. Malaviya et al. (2022) analyzed data from the Dubai Household Health Survey and found that PHI increased healthcare utilization among citizens and white-collar expatriates, but not among blue-collar laborers (e.g. construction, manual, and cleaning workers). This difference was attributed to less comprehensive PHI coverage benefits and additional barriers, such as limited awareness and demanding work conditions. Accordingly, having more comprehensive PHI coverage did not necessarily lead to higher utilization in this group, as utilization was also influenced by demographic factors, employment characteristics, and health awareness [36].
+
+In KSA, researchers have found that a low understanding of the benefits of health insurance among expatriates who had PHI was associated with less access to healthcare services (OR = 0.393, CI = 0.335–0.461), which highlights the importance of expatriates’ knowledge about the benefits of PHI rather than the details of numerical copays [37]. In contrast, another study in Saudi Arabia found that adult patients with chronic diseases who had PHI were more likely to revisit emergency departments (ED) compared with those without PHI (aRR = 4.23, 95% CI: 2.60–6.90; p = 0.001) [38].
+
+Additionally, studies in both KSA and the UAE reported that PHI was associated with improved adherence to long-term treatment. In a university hospital in Saudi Arabia, patients with PHI had significantly higher adherence scores to antiplatelet therapy (33 ± 4.5) than those with GHC (30.6 ± 3.4) [39]. Similarly, in the United Arab Emirates, it was shown that adherence to treatment for multimorbidity was significantly higher among patients with PHI (77.5%) [40].
+
+A study in KSA found that the number of prescribed medicines (mean = 3.37 ± SD = 2.10) and their prices (mean = 460 SR ± SD = 387.3) were significantly higher among individuals with PHI compared with those without [41]. However, a survey of 16 insurance companies to investigate their policies regarding pharmaceutical coverage revealed that there was marked inconsistency in the regulations regarding the maximum time of treatment and allowed refill of treatment for patients with PHI [42]. From another perspective, a study in Saudi Arabia found that PHI was associated with a paradoxical effect on out-of-pocket expenditures among individuals with PHI across socioeconomic statuses. While there was a reduction in health and medicine expenditures among low-income patients, the opposite occurred as income increased. Researchers have claimed that healthcare providers benefit from high-income patients by prescribing medicine that is not covered by PHI [43].
+
+In Qatar, all types of PHI were associated with higher inpatient and outpatient service utilization for both citizens and expatriates compared with those without any form of PHI, even after controlling for other factors, such as age, gender, and marital status, which indicated that improving PHI could promote greater utilization of care [44].
+
+In KSA, one study compared individuals with PHI and those without PHI in terms of the quality and fairness of health services in a tertiary hospital; the results revealed that the patients with PHI rated their services as high quality and fair, while the patients without PHI had been subjected to prolonged waiting periods, payment procedures, and differences in treatment [45]. On the other hand, a study conducted in Qatar found no statistically significant difference in overall satisfaction between individuals with PHI and those without. While a study from KSA indicated higher satisfaction among PHI beneficiaries, the findings from Qatar suggest no significant difference. This inconsistency may be due to variations in the benefit package or quality of services provided by PHI, which can differ among countries [46].
+
+PHI was positively associated with health service utilization, particularly check-ups, periodic preventive services, inpatient and outpatient services, ED visits, and medication dispensing. Moreover, PHI was positively associated with the behavior and attitudes of beneficiaries, as indicated by the increased adherence to treatment and positive perceptions about the quality of received services. In addition, PHI was positively associated with higher utilization of complementary and alternative medicines and increased out-of-pocket expenditures on medicines, especially among highly wealthy individuals. However, higher utilization among PHI holders does not necessarily indicate improved equity. Several included studies suggest that the utilization gains under PHI may be concentrated among higher-income or better-covered groups, whereas low-income or low-literacy workers may face benefit limitations and informational barriers, which can widen socioeconomic differences in access and use [34,36,37]. Table 3 summarizes the evidence from included studies showing that PHI is positively associated with increased healthcare utilization.Table 3. Summary of studies on the association between private health insurance and healthcare service utilization.
+
+Study	Country	Design	Population (n)	Type of service	Association with PHI*	Effect size	Effect size metric**	
+Al-Hanawi et al. 2020	Saudi Arabia	Cross-sectional	National adult sample from SFHS 2018 (n = 8845)	Medical checkup	Positive	↑ 17%	Percentage	
+Al-Hanawi and Chirwa 2021	Saudi Arabia	Cross-sectional	National adult sample from SFHS 2018 (n = 11,528)	Periodic preventive services	Positive	OR = 2.29; 95% CI = 2.02–2.59	Odds ratio	
+Alsubaie et al. 2016	Saudi Arabia	Cross-sectional	Tertiary hospital PHC attendees, Riyadh (n = 358)	Visits to primary healthcare	Positive	(OR = 8.333; 95% CI = 1.037–66.667, p = 0.046)	Odds ratio	
+Radwan et al. 2020	United Arab Emirates	Cross-sectional	T2DM outpatients in two governmental hospitals (Dubai and Sharjah), n = 244	Use complementary and alternative medicine in T2DM	Positive	OR: 2.08; CI: 1.11–3.86	Odds ratio	
+Malaviya et al. 2022	United Arab Emirates	Cross-sectional	Dubai Household Health Survey in 2014 and 2018 (households: 3271 in 2014; 2200 in 2018)	Inpatients and outpatient services	Positive	↑ 80% from 2014 to 2018	Percentage	
+Alkhamis 2018	Saudi Arabia	Cross-sectional	Male expatriates with PHI in Riyadh (n = 3398)	Lack of access to healthcare (past 1 year)	Negative association with knowledge level	OR = 0.393, CI = 0.335–0.461	Odds ratio	
+Anwar E. Ahmed et al. 2018	Saudi Arabia	Retrospective study	Adults with chronic diseases at KAMC adult ED, Riyadh (n = 24,206)	Revisits of chronic diseases’ adult patients to emergency department	Positive	aRR = 4.23, CI: 2.60–6.90	Adjusted relative rate	
+Liu et al. 2020	Qatar	Cross-sectional	Adults reporting illness in the Household Utilization and Expenditure Survey 2014 (n = 3016)	Inpatients and outpatient services	Positive	↑ 11% for citizens and 22% for expatriates	Percentage	
+Alrabiah et al. 2020	Saudi Arabia	Cross-sectional	Adults with acute coronary syndrome receiving dual antiplatelet therapy in a cardiac outpatient clinic, Riyadh (n = 192)	Adherence to prophylactic treatment	Positive	PHI SEAMS = (33 ± 4.5)	Mean ± SD	
+Allaham et al. 2022	United Arab Emirates	Cross-sectional	Adults with ≥2 chronic diseases attending outpatient clinics in two tertiary hospitals in Dubai (n = 630)	Adherence to multimorbidity treatment	Positive	77.5% in privately insured	Percentage	
+Al-Mohamadi et al. 2014	Saudi Arabia	Prospective study	Patients with chronic diseases in three private hospitals, Jeddah (n = 363)	Number of prescribed medications and total prescription cost	Positive (patients with PHI received more and higher cost medications)	Number of prescribed items was higher among patients with PHI than without PHI patients (6.82 ± 3.23 vs. 4.84 ± 2.70), and the total prescription cost was also higher for those with PHI (638 ± 386.6 vs. 460 ± 387.3 SAR)	Mean ± SD	
+Bawazir et al. 2013	Saudi Arabia	Cross-sectional	PHI companies (16 companies)	Pharmaceutical coverage policies (maximum treatment duration and refill limits)	Not applicable (policy-level variability in PHI benefits)	Differences in treatment duration and refill rules between PHI companies	Not applicable	
+(Al-Hanawi, Mwale, and Qattan 2021	Saudi Arabia	Cross-sectional	Nationally representative sample from the 2018 SFHS (n = 8,655)	Out-of-pocket expenditure on health and medicines	Mixed pattern	PHI reduces OOP spending on health by 3.6% and on medicines by 5.2%, but OOP slightly increases with higher income among PHI holders (+0.4% for health and +0.5% for medicines).	Percentage	
+Binsaeed et al. 2022	Saudi Arabia	Cross-sectional	Adults attending a public tertiary hospital in Riyadh (n = 350)	Quality of services	Positive	(Mean perceived quality = 3.37, SD = 0.525) in privately insured, and (3.06, SD = 0.452, p 0.001) in uninsured	Mean ± SD	
+Khaled, Shockley, and Abdul Rahim 2017	Qatar	Cross-sectional	Nationally representative adults ≥18 years with satisfaction data (n = 2751)	Satisfaction about health services	No significant association	OR = 1.65, CI = 0.97–2.82, p = 0.20	Odds ratio	
+*‘Positive’ indicates higher utilization among individuals with PHI compared with those without PHI; ‘negative’ indicates lower utilization.
+
+Table 4 summarizes the categorization of the determinants of PHI uptake and healthcare utilization patterns based on the Andersen’s BMHSU, providing a structured framework to interpret how predisposing, enabling, and need factors interact to shape patterns of access and service use across the included studiesTable 4. Mapping of identified determinants and healthcare utilization patterns to Andersen BMHSU categories.
+
+Study	Focus Area (Uptake/Utilization)	Finding	Andersen Model Category	Classification Rationale	
+Al-Hanawi et al. 2018	Uptake	Willingness to pay for obtaining PHI is influenced by higher education level, higher income, household size, and type of healthcare financing	Predisposing + enabling	Sociodemographic characteristic (predisposing); healthcare financing and satisfaction (enabling)	
+Al Mustanyir, Turner, and Mulcahy 2022	Uptake	Willingness to pay for obtaining PHI associated with higher among males, employed, married, older adults, and those with chronic conditions	Predisposing + enabling + need	Demographics (predisposing); perceived need for higher quality healthcare services (enabling); chronic disease (need)	
+Alharbi 2022	Uptake	Willingness to pay for obtaining National Health Insurance was positively associated with higher education, male gender, older age, higher income, and previous insurance experience	Predisposing	Although focused on NHI, which was not started in Saudi Arabia, the study measured Willingness to pay as a proxy for potential interest in PHI. The identified determinants reflect socioeconomic and demographic factors relevant to PHI uptake decisions	
+Alharbi 2021	Uptake	Government school workers’ Willingness to pay was higher among males, the educated, and the chronically ill	Predisposing + Need	Gender and education (predisposing); health condition (need)	
+Al-Hanawi, Alsharqi, and Vaidya 2020	Uptake	Willingness to pay for obtaining PHI, driven by a perceived need for higher-quality healthcare services and improved public healthcare, was associated with male gender, higher income, higher education, and older age	Predisposing + enabling	Gender, age, education (predisposing); income, dissatisfaction, and PHI (enabling)	
+Alkhamis et al. 2017	Uptake	PHI is more likely among married expatriates with technical jobs and higher education	Predisposing	Marital and occupational status reflect demographic predisposition	
+Almalki, Alahmari, Alqahtani et al. 2022	Uptake	Out-of-pocket (OOP) spending was significantly higher among individuals with PHI who had multiple chronic conditions, likely due to increased healthcare needs and service utilization	Need + enabling	Chronic illness reflects objective need; the PHI holder indicates enabling access and financial capacity	
+Almalki, Alahmari, Alqahtani et al. 2022	Uptake	OOP spending was significantly higher among PHI holders with multiple chronic conditions, likely due to the anticipated need for frequent healthcare	Need + enabling	Chronic illness reflects need. Holding PHI indicates an enabling factor that facilitates access to healthcare	
+Al-Hanawi et al. 2021	Uptake	Inequality in OOP expenditure related to income differences among PHI holders	Enabling	Income level affects both access and may influence individuals’ perceptions of the value and adequacy of PHI and affect future enrollment decisions	
+Alshamsan et al. 2017	Uptake	Individuals without PHI had to borrow for healthcare	Enabling	Lack of financial resources influences the inability to enroll in PHI	
+Radwan et al. 2020	Uptake	79% of T2DM patients had PHI	Need	Chronic disease status motivates insurance uptake	
+Al-Hanawi et al. 2020	Utilization	PHI was positively associated with the likelihood of seeking medical check-ups by 17%	Enabling	PHI coverage facilitates access to preventive care	
+Al-Hanawi and Chirwa 2021	Utilization	PHI associated with higher periodic preventive check-ups (OR = 2.29)	Enabling	PHI facilitates access to routine care, increasing utilization	
+Alsubaie et al. 2016	Utilization	PHI holders are less likely to use public PHC; prefer private healthcare	Enabling	PHI reduces cost burden, encouraging service use	
+Radwan et al. 2020	Utilization	T2DM patients with PHI more likely to use CAM (OR: 2.08)	Enabling + predisposing	PHI holders associated with employed individuals can afford CAM based on income and job class	
+Malaviya et al. 2022	Utilization	PHI increased utilization among citizens and white-collar expatriates but not among blue-collar laborers; differences attributed to demographic and occupational class	Enabling + predisposing	Occupational class and demographic profile (e.g. younger, healthier blue-collar workers) reflect predisposing factors; PHI coverage reflects enabling factor, though effect varies by socioeconomic subgroup	
+Alkhamis 2018	Utilization	Poor knowledge of PHI benefits linked to lower access (OR = 0.393)	Enabling	Knowledge about PHI serves as an enabling factor that facilitates informed access and effective use of healthcare services	
+Anwar E. Ahmed et al. 2018	Utilization	PHI holders with chronic diseases were significantly more likely to revisit emergency departments compared with non-PHI holders (RR = 4.23)	Need + enabling	Chronic disease represents a need factor; PHI coverage serves as an enabling factor that facilitates access to emergency care	
+Anwar E. Ahmed et al. 2018	Utilization	KSA and UAE: PHI associated with better adherence to long-term treatment	Need + enabling	Chronic disease represents a need factor; PHI coverage serves as an enabling factor that facilitates access to emergency care	
+Alrabiah et al. 2020	Utilization	Patients with PHI had significantly higher adherence to antiplatelet therapy compared to those with GHC	Enabling	PHI coverage facilitates consistent access to medications and follow-up care, supporting long-term treatment adherence	
+Allaham et al. 2022	Utilization	Adherence to treatment for multimorbidity was significantly higher among patients with PHI (77.6%)	Enabling	PHI improves access to needed medications and continuity of care	
+Al-Mohamadi et al. 2014	Utilization	The number of prescribed medicines (mean difference = 3.37 ± SD = 2.10) and their prices (mean difference = 460 SR ± SD = 387.3) were significantly higher among individuals with PHI compared to those without	Enabling	PHI facilitates greater access to medications, potentially leading to more prescriptions and higher pharmaceutical expenditures	
+Bawazir et al. 2013	Utilization	Differences in PHI plans’ treatment duration and refill rules may limit access to needed medications	Enabling	PHI policy terms affect access to continuous medication and treatment adherence	
+Al-Hanawi MK 2021	Utilization	PHI had a paradoxical effect on OOP spending: reduced among low-income individuals, but increased among high-income PHI holders, possibly due to uncovered prescriptions	Enabling	Socioeconomic status and PHI coverage influence financial access and provider behavior, affecting actual healthcare costs and service utilization	
+Liu et al. 2020	Utilization	PHI was associated with higher utilization of inpatient and outpatient services among both citizens and expatriates	Enabling	PHI facilitates access to healthcare services and removes financial and administrative barriers to utilization	
+Binsaeed et al. 2022	Utilization	PHI holders perceived higher quality and fairness in services, while non-PHI patients reported longer wait times, payment burdens, and treatment disparities	Enabling	Having PHI facilitates access to more efficient and equitable care, influencing patients’ experiences and satisfaction with service quality	
+
+Discussion
+
+In this systematic review, we found that sociodemographic and socioeconomic characteristics, such as gender, age, marital status, education level, employment status, and monthly income, were consistently associated with PHI uptake. Regarding healthcare utilization, most included studies reported that having PHI was associated with higher healthcare utilization compared to those without PHI, although one study found a negative association.
+
+Variability in the reported determinants across studies may partly reflect evolving health policies and eligibility criteria over the past decade. In particular, the regional transition from universal public health coverage for all residents to a model that provides free care primarily to citizens and selected expatriate groups, alongside the introduction of mandatory PHI for private-sector expatriates, has fundamentally reshaped the determinants of insurance enrollment and service use. This policy shift has created a clearer and more stratified context for examining how individuals engage with healthcare services under differing insurance regimes [2,9,10].
+
+According to Andersen’s BMHSU, healthcare utilization is determined by three interrelated categories of factors that collectively shape access and use of care. Predisposing factors refer to the demographic and attitudinal characteristics of individuals; enabling factors capture the financial and structural resources, such as health insurance status and service availability that facilitate access to care; and need factors represent both the perceived and objectively assessed health requirements that drive healthcare utilization [47]. In line with the BMHSU (1973), the current review demonstrated that sociodemographic characteristics represented the predisposing factor, while health status (for instance, chronic disease) represented the ‘need,’ and quality of healthcare services represented the ‘enabling’ factor. Similar findings were recognized in another systematic review carried out in Iran, which revealed that healthcare utilization was influenced by the sociodemographic variables of the household, health status, and type of health services [48].
+
+Several included studies revealed that PHI had a positive association with the utilization of health services, especially check-up services, periodic preventive services, in-patient and outpatient services, visits to the ED, and dispensing medicines. Moreover, these findings highlight the need to explore possible mechanisms through which PHI encourages utilization (e.g. reduced financial barriers and high-quality services). However, the generalizability of these findings is limited by variations in study populations and the types of health services assessed across the included studies [17,49–52]. This pattern aligns with Andersen’s BMHSU, suggesting that PHI can be understood as an enabling factor that facilitates access to healthcare by reducing financial barriers and enhancing service availability. Nevertheless, differences in benefit coverage, employment type, and income levels across GCC countries may shape the extent to which PHI improves healthcare utilization, raising important considerations for equity within the region’s ongoing health system reforms.
+
+Chronic noncommunicable diseases are a leading factor in the utilization of healthcare services. Chronic diseases require a long period of treatment with frequent visits to healthcare facilities, resulting in an extra burden on the health system as well as the patients [53]. In the United States, the direct cost of treating chronic disease patients totaled 1.1 trillion dollars in 2003, and the indirect cost of economic productivity is projected to reach $3.7 trillion in 2023 [54]. Patients who are the customers of healthcare services have expectations for the quality of service that warrant satisfaction [55]; therefore, as anticipated, two of the reviewed studies reported that the willingness to pay for PHI was conditional on the improved quality of health services [25,27]. Within Andersen’s BMHSU, chronic illness represents a ‘need’ factor that strongly drives healthcare utilization, while PHI can function as an enabling factor that mitigates the financial burden of long-term treatment. In the GCC context, where the prevalence of chronic diseases is rapidly increasing, ensuring financial protection through comprehensive PHI coverage aligns with ongoing health system reforms aimed at achieving UHC [56].
+
+One notable issue identified in this review is the disparities in healthcare usage between expatriates and citizens, specifically among low-income migrant workers, which reflects unequal access to and use of health services. PHI is a requirement for expatriates throughout the GCC, but various studies show that low-income or less educated expatriates tend to receive limited benefit coverage, with restricted provider networks, and at the same time have insufficient knowledge of their rights [3,36]. Therefore, this group tends to underutilize preventive and chronic care services, which may contribute to disparities in healthcare utilization. From Andersen’s perspective, these disparities reflect inequalities in enabling factors, such as financial resources and health literacy. Such structural gaps may hinder progress toward equity within ongoing GCC health reforms, underscoring the need for more inclusive and equitable PHI policies.
+
+While the current study revealed that knowledge about the benefits of PHI and perceptions of high-quality service are associated with a greater likelihood of enrollment in PHI, Dror et al. (2016) described these factors as enablers in addition to trust in scheme management [57]. Knowledge about PHI could be viewed as a crucial factor in determining enrollment in PHI in Gulf States, due to the relatively high percentage of expatriates who mainly originate from different countries worldwide, particularly from low-income countries with diverse cultures and health systems. This knowledge may include understanding what healthcare services are covered, how to access care, and how to file a claim [57]. Since PHI enrollment is mandatory for expatriates in the GCC countries, the primary concern shifts from initial uptake to ensuring adequate awareness and understanding of the utilization of PHI benefits. In addition, Dror et al. (2016) identified the factors that encourage the renewal of PHI, including the receipt of an insurance payout the previous year, and the barriers to renewal, which included (a) stringent rules of some Community-Based Health Insurance (CBHI) schemes, (b) inadequate legal and policy frameworks to support CBHI and (c) limited or inappropriate benefits packages [57].
+
+This systematic review provided policymakers and healthcare providers in GCC countries with actionable insights on how PHI can complement national health financing schemes within UHC initiatives. These insights include strengthening regulation of employer-based coverage, defining minimum benefit standards that include primary and preventive care, and improving insurance literacy to support appropriate and equitable healthcare utilization, particularly among low-income expatriates.
+
+Limitations of the study
+
+This study has several limitations. First, the availability of published research was uneven across GCC countries, with some countries having more studies than others. In particular, most of the included studies were conducted in KSA (19 out of 26). This uneven distribution limited our ability to conduct balanced comparisons between these countries. In addition, smaller GCC countries may differ from KSA in labor markets and PHI regulation, which may bias the findings and limit their generalizability across the GCC region. Second, the study populations across the reviewed articles were different, thereby potentially impacting the generalizability of the findings. Third, the types of investigated health services were inconsistent, thus making direct comparisons challenging. Fourth, because ‘health insurance’ is a broad term, some misclassification is possible; however, we screened studies to ensure that coverage corresponded to private health insurance. Lastly, due to the limited number of studies and heterogeneity in the types of health services examined, we were unable to perform a meta-analysis. Additionally, the exclusion of gray literature may have introduced publication bias.
+
+Conclusions and recommendations
+
+The growing challenges facing healthcare systems worldwide have led the GCC countries to adopt reforms aimed at ensuring the sustainability of UHC. Although GHC has long provided broad access to care, the increasing population diversity and rising healthcare demand have prompted the integration of PHI as a complementary mechanism. The current study highlights the role of PHI in increasing health service utilization, which will help improve access and system efficiency during the current period of transition toward UHC.
+
+The factors associated with PHI uptake included male sex, older age, being married, higher educational level, a high monthly income, and chronic disease. Eventually, PHI was positively associated with increased utilization of healthcare services, particularly check-up services, periodic preventive services, inpatient and outpatient services, and ED visits, as well as increased dispensing of medications. The willingness of people in GCC countries to pay for PHI was conditional on improved quality, which will influence the efficiency of health service utilization. Although PHI is mandatory for expatriate workers in GCC countries, those with low-income and limited education often receive minimal coverage and may lack awareness of how to fully utilize their insurance benefits.
+
+We recommend that governments and regulators, who hold the primary responsibility for addressing health inequalities and unmet needs, require PHI companies, in collaboration with employers, to develop tailored insurance policies for expatriate workers with low-income and limited health awareness, as these groups are less likely to engage in preventive healthcare. Such collaboration could include orientation workshops and the distribution of simplified multilingual booklets to enhance awareness of entitlements, claims procedures, and available benefits. Moreover, policymakers should consider incentives or subsidies for employers who provide high-quality PHI to their employees. PHI policies should also establish clear and transparent claims mechanisms and grievance redressal systems that are accessible to individuals with limited administrative literacy.
+
+Supplementary Material
+
+PRISMA_2020_checklist.docx
+
+Supplementary_Table_S2_Data_extraction.xlsx
+
+Supplementary_Table_S3_Quality assessment_qualitative_studies.xlsx
+
+Supplementary_Table_S4_Quality assessment_quantitative studies.xlsx
+
+Supplementary_Table_S1_Search_Strategy.docx
+
+Acknowledgments
+
+KA, JK, MH, and SA conceived and designed the review protocol, coordinated the project, and supervised the overall process.
+
+KA, MBB conducted the literature search, screened titles, and abstracts, and performed full-text assessments.
+
+KA, MBB extracted and synthesized the data and contributed to the risk of bias assessment.
+
+KA, MBB performed the statistical analysis and contributed to the interpretation of results.
+
+KA, JK, MH, SA drafted the manuscript.
+
+All authors critically revised the manuscript for important intellectual content and approved the final version.
+
+Availability of data and materials
+
+The datasets supporting the conclusions and used for the review article are included within the article and its additional files.
+
+Disclosure statement
+
+No potential conflict of interest was reported by the author(s).
+
+Ethics and consent
+
+Ethics approval was not required because this study used data synthesized from already published studies.
+
+Supplementary material
+
+Supplemental data for this article can be accessed online at https://doi.org/10.1080/16549716.2026.2647528.
+
+
+References
+
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diff --git a/corpus/music/deltas/00a2389583fcf984.txt b/corpus/music/deltas/00a2389583fcf984.txt
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+Score-Informed Transformer for Refining MIDI Velocity in Automatic Music Transcription
+
+MIDI velocity is crucial for capturing expressive dynamics in human performances. In practical scenarios, a music score with inaccurate velocities may be available alongside the performance audio (e.g., music education and free online archives), enabling the task of score-informed MIDI velocity estimation. In this work, we propose a modular, lightweight score-informed Transformer correction module that refines the velocity estimates of Automatic Music Transcription (AMT) systems. We integrate the proposed module into multiple AMT systems (HPT, HPPNet, and DynEst). Trained exclusively on the MAESTRO training split, our method consistently reduces velocity estimation errors on MAESTRO and improves cross-dataset generalization to SMD and MAPS datasets. Under this training protocol, integrating our score-informed module with HPT (named Score-HPT) establishes a new state-of-the-art performance, outperforms existing score-informed methods and velocity-enabled AMT systems while adding only 1 M parameters.
diff --git a/corpus/music/deltas/0ce280c82f436277.txt b/corpus/music/deltas/0ce280c82f436277.txt
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+RA-QA: A Benchmarking System for Respiratory Audio Question Answering Under Real-World Heterogeneity
+
+As conversational multimodal AI tools are increasingly adopted to process patient data for health assessment, robust benchmarks are needed to measure progress and expose failure modes under realistic conditions. Despite the importance of respiratory audio for mobile health screening, respiratory audio question answering remains underexplored, with existing studies evaluated narrowly and lacking real-world heterogeneity across modalities, devices, and question types. We hence introduce the \textbf{Respiratory-Audio Question-Answering (RA-QA) benchmark}, including a standardized data generation pipeline, a comprehensive multimodal QA collection, and a unified evaluation protocol. RA-QA harmonizes public RA datasets into a collection of 9 million format-diverse QA pairs covering diagnostic and contextual attributes. We benchmark general audio-language models as well as domain-specific architectures, establishing reproducible reference points and showing how current approaches fail under heterogeneity.
diff --git a/corpus/music/deltas/105658c3846f2279.txt b/corpus/music/deltas/105658c3846f2279.txt
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+Integrating IP Broadcasting with Audio Tags: Workflow and Challenges
+
+The broadcasting industry has adopted IP technologies, revolutionising both live and pre-recorded content production, from news gathering to live music events. IP broadcasting allows for the transport of audio and video signals in an easily configurable way, aligning with modern networking techniques. This shift towards an IP workflow allows for much greater flexibility, not only in routing signals but with the integration of tools using standard web development techniques. One possible tool could include the use of live audio tagging, which has a number of uses in the production of content. These could include adding sound effects to automated closed captioning or identifying unwanted sound events within a scene. In this paper, we describe the process of containerising an audio tagging model into a microservice, a small segregated code module that can be integrated into a multitude of different network setups. The goal is to develop a modular, accessible, and flexible tool capable of seamless deployment into broadcasting workflows of all sizes, from small productions to large corporations. Challenges surrounding latency of the selected audio tagging model and its effect on the usefulness of the end product are discussed.
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diff --git a/corpus/music/deltas/163ccbf5ce103088.txt b/corpus/music/deltas/163ccbf5ce103088.txt
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+Audio-Visual Instance Segmentation
+
+In this paper, we propose a new multi-modal task, termed audio-visual instance segmentation (AVIS), which aims to simultaneously identify, segment and track individual sounding object instances in audible videos. To facilitate this research, we introduce a high-quality benchmark named AVISeg, containing over 90K instance masks from 26 semantic categories in 926 long videos. Additionally, we propose a strong baseline model for this task. Our model first localizes sound source within each frame, and condenses object-specific contexts into concise tokens. Then it builds long-range audio-visual dependencies between these tokens using window-based attention, and tracks sounding objects among the entire video sequences. Extensive experiments reveal that our method performs best on AVISeg, surpassing the existing methods from related tasks. We further conduct the evaluation on several multi-modal large models. Unfortunately, they exhibits subpar performance on instance-level sound source localization and temporal perception. We expect that AVIS will inspire the community towards a more comprehensive multi-modal understanding. Dataset and code is available at https://github.com/ruohaoguo/avis.
diff --git a/corpus/music/deltas/16b23f794d28e7cc.txt b/corpus/music/deltas/16b23f794d28e7cc.txt
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+Membership Inference Attacks against Large Audio Language Models
+
+We present the first systematic Membership Inference Attack (MIA) evaluation of LALMs. Using Multi-modal Blind Baselines based on textual, spectral and prosodic features, we demonstrate that common audio datasets exhibit near-perfect train/test separability (AUC ~ 1.0) even without model inference, thus MIA may primarily detect distribution shift. We therefore introduce a blind-baseline protocol to control for this confound. Under this protocol, we identify that the distribution-matched datasets enable reliable MIA evaluation without distribution-shift artifacts. We benchmark multiple MIA methods and conduct modality disentanglement experiments on these datasets. The results reveal that LALM memorization is cross-modal, arising only from binding a speaker's vocal identity with its text. These findings establish a principled standard for auditing LALMs beyond spurious correlations. Our codebase is available at https://github.com/snooow1029/ALM_MIA.
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diff --git a/corpus/music/deltas/17fbc11813570020.pdf b/corpus/music/deltas/17fbc11813570020.pdf
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diff --git a/corpus/music/deltas/206fdad84df6eded.txt b/corpus/music/deltas/206fdad84df6eded.txt
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+Automatic Curation of Large-Scale, High-Quality, Multi-Category Music Source Separation Dataset
+
+Most current music source separation (MSS) methods rely on supervised learning, limited by training data quantity and quality. Though web-crawling can bring abundant data, platform-level track labeling often causes metadata mismatches, impeding accurate "audio-label" pair acquisition. To address this, we present ACMID: a dataset for MSS generated through web crawling of extensive raw data, followed by automatic cleaning via an instrument classifier built on a pre-trained audio encoder that filters and aggregates clean segments of target instruments from the crawled tracks, resulting in the refined ACMID-Cleaned dataset. Leveraging abundant data, we expand the conventional classification from 4-stem (Vocal/Bass/Drums/Others) to 7-stem (Piano/Drums/Bass/Acoustic Guitar/Electric Guitar/Strings/Wind-Brass), enabling high granularity MSS systems. Experiments on SOTA MSS model demonstrates two key results: (i) MSS model trained with ACMID-Cleaned achieved a 2.39dB improvement in SDR performance compared to that with ACMID-Uncleaned, demostrating the effectiveness of our data cleaning procedure; (ii) incorporating ACMID-Cleaned to training enhances MSS model's average performance by 1.16dB, confirming the value of our dataset. Our data crawling code, cleaning model code and weights are available at: https://github.com/scottishfold0621/ACMID.
diff --git a/corpus/music/deltas/235a0fb8d513ad70.txt b/corpus/music/deltas/235a0fb8d513ad70.txt
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+VidMuse: A Simple Video-to-Music Generation Framework with Long-Short-Term Modeling
+
+In this work, we systematically study music generation conditioned solely on the video. First, we present a large-scale dataset comprising 360K video-music pairs, including various genres such as movie trailers, advertisements, and documentaries. Furthermore, we propose VidMuse, a simple framework for generating music aligned with video inputs. VidMuse stands out by producing high-fidelity music that is both acoustically and semantically aligned with the video. By incorporating local and global visual cues, VidMuse enables the creation of musically coherent audio tracks that consistently match the video content through Long-Short-Term modeling. Through extensive experiments, VidMuse outperforms existing models in terms of audio quality, diversity, and audio-visual alignment. The code and datasets are available at https://vidmuse.github.io/.
diff --git a/corpus/music/deltas/3fe0f9357bed2398.txt b/corpus/music/deltas/3fe0f9357bed2398.txt
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+++ b/corpus/music/deltas/3fe0f9357bed2398.txt
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+From Audio Deepfake Detection to AI-Generated Music Detection -- A Pathway and Overview
+
+As Artificial Intelligence (AI) technologies continue to evolve, their use in generating realistic, contextually appropriate content has expanded into various domains. Music, an art form and medium for entertainment deeply rooted in human culture, is seeing an increased involvement of AI into its production. However, the unregulated use of AI music generation (AIGM) tools raises concerns about potential negative impacts on the music industry, copyright, and artistic integrity, underscoring the importance of effective AIGM detection. This paper provides a systematic overview of existing AIGM detection methods. We first establish a four-level detection taxonomy: signal-level, feature-level, watermark, and semantic consistency, organising methods according to the type of trace they exploit. Drawing on the more mature field of audio deepfake detection, we then present a stratified transferability analysis that examines which components may or may not transfer to AIGM detection, and under what conditions. A multi-dimensional classification further organises representative methods along input modality, detection granularity, feature type, model type, detection target, robustness setting, and interpretability. We conclude by discussing implications and proposing directions for future research to address ongoing challenges in the field.
diff --git a/corpus/music/deltas/4145f274b492216b.pdf b/corpus/music/deltas/4145f274b492216b.pdf
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diff --git a/corpus/music/deltas/571a4060d979c10e.pdf b/corpus/music/deltas/571a4060d979c10e.pdf
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diff --git a/corpus/music/deltas/6839dd7a4f6696eb.txt b/corpus/music/deltas/6839dd7a4f6696eb.txt
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+Annotation-Free MIDI-to-Audio Synthesis via Concatenative Synthesis and Generative Refinement
+
+Recent MIDI-to-audio synthesis methods using deep neural networks have successfully generated high-quality, expressive instrumental tracks. However, these methods require MIDI annotations for supervised training, limiting the diversity of instrument timbres and expression styles in the output. We propose CoSaRef, a MIDI-to-audio synthesis method that does not require MIDI-audio paired datasets. CoSaRef first generates a synthetic audio track using concatenative synthesis based on MIDI input, then refines it with a diffusion-based deep generative model trained on datasets without MIDI annotations. This approach improves the diversity of timbres and expression styles. Additionally, it allows detailed control over timbres and expression through audio sample selection and extra MIDI design, similar to traditional functions in digital audio workstations. Experiments showed that CoSaRef could generate realistic tracks while preserving fine-grained timbre control via one-shot samples. Moreover, despite not being supervised on MIDI annotation, CoSaRef outperformed the state-of-the-art timbre-controllable method based on MIDI supervision in both objective and subjective evaluation.
diff --git a/corpus/music/deltas/69b18150155ed5a8.txt b/corpus/music/deltas/69b18150155ed5a8.txt
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+CSyMR: Benchmarking Compositional Music Information Retrieval in Symbolic Music Reasoning
+
+Natural language information needs over symbolic music scores rarely reduce to a single step lookup. Many queries require compositional Music Information Retrieval (MIR) that extracts multiple pieces of evidence from structured notation and aggregates them to answer the question. This setting remains challenging for Large Language Models due to the mismatch between natural language intents and symbolic representations, as well as the difficulty of reliably handling long structured contexts. Existing benchmarks only partially capture these retrieval demands, often emphasizing isolated theoretical knowledge or simplified settings. We introduce CSyMR-Bench, a benchmark for compositional MIR in symbolic music reasoning grounded in authentic user scenarios. It contains 126 multiple choice questions curated from community discussions and professional examinations, where each item requires chaining multiple atomic analyses over a score to derive implicit musical evidence. To support diagnosis, we provide a taxonomy with six query intent categories and six analytical dimension tags. We further propose a tool-augmented retrieval and reasoning framework that integrates a ReAct-style controller with deterministic symbolic analysis operators built with music21. Experiments across prompting baselines and agent variants show that tool-grounded compositional retrieval consistently outperforms Large Language Model-only approaches, yielding 5-7% absolute accuracy gains, with the largest improvements on analysis-heavy categories.
diff --git a/corpus/music/deltas/6a297c7d1abeb445.txt b/corpus/music/deltas/6a297c7d1abeb445.txt
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+Comparison of linear and nonlinear methods for decoding selective attention to speech from ear-EEG recordings
+
+Many people with hearing loss struggle to comprehend speech in crowded auditory scenes, even when they are using hearing aids. It has recently been demonstrated that the focus of a listener's selective attention to speech can be decoded from their electroencephalography (EEG) recordings, raising the prospect of smart EEG-steered hearing aids which restore speech comprehension in adverse acoustic environments (such as the cocktail party). To this end, we here assess the feasibility of using a novel, ultra-wearable ear-EEG device to classify the selective attention of normal-hearing listeners who participated in a two-talker competing-speakers experiment. Eighteen participants took part in a diotic listening task, whereby they were asked to attend to one narrator whilst ignoring the other. Encoding models were estimated from the recorded signals, and these confirmed that the device has the ability to capture auditory responses that are consistent with those reported in high-density EEG studies. Several state-of-the-art auditory attention decoding algorithms were next compared, including stimulus-reconstruction algorithms based on linear regression as well as non-linear deep neural networks, and canonical correlation analysis (CCA). Meaningful markers of selective auditory attention could be extracted from the ear-EEG signals of all 18 participants, even when those markers were derived from relatively short EEG segments of just five seconds in duration. Algorithms which related the EEG signals to the rising edges of the speech temporal envelope (onset envelope) were more successful than those which made use of the temporal envelope itself. The CCA algorithm achieved the highest mean attention decoding accuracy, although differences between the performances of the three algorithms were both small and not statistically significant when EEG segments of short durations were employed.
diff --git a/corpus/music/deltas/6eb5daafce37c429.pdf b/corpus/music/deltas/6eb5daafce37c429.pdf
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diff --git a/corpus/music/deltas/71ac8173d935b353.pdf b/corpus/music/deltas/71ac8173d935b353.pdf
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diff --git a/corpus/music/deltas/7569ab95d73f6f88.pdf b/corpus/music/deltas/7569ab95d73f6f88.pdf
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diff --git a/corpus/music/deltas/7cca8fa7b09bdd31.pdf b/corpus/music/deltas/7cca8fa7b09bdd31.pdf
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diff --git a/corpus/music/deltas/81ed02cedc2cdf96.txt b/corpus/music/deltas/81ed02cedc2cdf96.txt
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+Weakly Supervised Detection and Temporal Localization of Whale Calls in Long-Duration Bioacoustic Data
+
+Passive acoustic monitoring (PAM) systems generate continuous recordings spanning months, yet automated bioacoustic analysis of whale calls requires two separate annotation efforts: binary presence labels for classification and precise temporal boundaries for localization. A binary label for a multi-minute recording can be assigned in seconds, but timestamping every call within it requires hours of expert effort. Providing both is infeasible at operational scale. We present DSMIL-LocNet, a weakly supervised multiple instance learning (MIL) framework that performs both classification and temporal localization using only recording-level presence/absence labels. Our dual-stream architecture integrates spectral and temporal features to process recordings of 2--30 minutes without the temporal compression that degrades existing CNN methods on long inputs. On the AcousticTrends BlueFinLibrary, DSMIL-LocNet achieves F1 scores of 0.88--0.91 on recordings of 300--1800s, where fully supervised CNN baselines degrade to 0.19--0.64. It also provides temporal localization that these baselines cannot produce without frame-level annotation. Code: https://github.com/Ragib-Amin-Nihal/DSMIL-Loc
diff --git a/corpus/music/deltas/82a49530f21bfb83.txt b/corpus/music/deltas/82a49530f21bfb83.txt
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+SONICS: Synthetic Or Not -- Identifying Counterfeit Songs
+
+The recent surge in AI-generated songs presents exciting possibilities and challenges. These innovations necessitate the ability to distinguish between human-composed and synthetic songs to safeguard artistic integrity and protect human musical artistry. Existing research and datasets in fake song detection only focus on singing voice deepfake detection (SVDD), where the vocals are AI-generated but the instrumental music is sourced from real songs. However, these approaches are inadequate for detecting contemporary end-to-end artificial songs where all components (vocals, music, lyrics, and style) could be AI-generated. Additionally, existing datasets lack music-lyrics diversity, long-duration songs, and open-access fake songs. To address these gaps, we introduce SONICS, a novel dataset for end-to-end Synthetic Song Detection (SSD), comprising over 97k songs (4,751 hours) with over 49k synthetic songs from popular platforms like Suno and Udio. Furthermore, we highlight the importance of modeling long-range temporal dependencies in songs for effective authenticity detection, an aspect entirely overlooked in existing methods. To utilize long-range patterns, we introduce SpecTTTra, a novel architecture that significantly improves time and memory efficiency over conventional CNN and Transformer-based models. For long songs, our top-performing variant outperforms ViT by 8% in F1 score, is 38% faster, and uses 26% less memory, while also surpassing ConvNeXt with a 1% F1 score gain, 20% speed boost, and 67% memory reduction.
diff --git a/corpus/music/deltas/8539f9957044bd46.txt b/corpus/music/deltas/8539f9957044bd46.txt
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+GOAT-TTS: Expressive and Realistic Speech Generation via A Dual-Branch LLM
+
+While large language models (LLMs) have revolutionized text-to-speech (TTS) synthesis through discrete tokenization paradigms, current architectures exhibit fundamental tensions between three critical dimensions: 1) irreversible loss of acoustic characteristics caused by quantization of speech prompts; 2) stringent dependence on precisely aligned prompt speech-text pairs that limit real-world deployment; and 3) catastrophic forgetting of the LLM's native text comprehension during optimization for speech token generation. To address these challenges, we propose an LLM-based text-to-speech Generation approach Optimized via a novel dual-branch ArchiTecture (GOAT-TTS). Our framework introduces two key innovations: (1) The modality-alignment branch combines a speech encoder and projector to capture continuous acoustic embeddings, enabling bidirectional correlation between paralinguistic features (language, timbre, emotion) and semantic text representations without transcript dependency; (2) The speech-generation branch employs modular fine-tuning on top-k layers of an LLM for speech token prediction while freezing the bottom-n layers to preserve foundational linguistic knowledge. Moreover, multi-token prediction is introduced to support real-time streaming TTS synthesis. Experimental results demonstrate that our GOAT-TTS achieves performance comparable to state-of-the-art TTS models while validating the efficacy of synthesized dialect speech data.
diff --git a/corpus/music/deltas/94da2f75077bfb71.txt b/corpus/music/deltas/94da2f75077bfb71.txt
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+Measuring Audio Prompt Adherence with Distribution-based Embedding Distances
+
+An increasing number of generative music models can be conditioned on an audio prompt that serves as musical context for which the model is to create an accompaniment (often further specified using a text prompt). Evaluation of how well model outputs adhere to the audio prompt is often done in a model or problem specific manner, presumably because no generic evaluation method for audio prompt adherence has emerged. Such a method could be useful both in the development and training of new models, and to make performance comparable across models. In this paper we investigate whether commonly used distribution-based distances like Fr\'echet Audio Distance (FAD), can be used to measure audio prompt adherence. We propose a simple procedure based on a small number of constituents (an embedding model, a projection, an embedding distance, and a data fusion method), that we systematically assess using a baseline validation. In a follow-up experiment we test the sensitivity of the proposed audio adherence measure to pitch and time shift perturbations. The results show that the proposed measure is sensitive to such perturbations, even when the reference and candidate distributions are from different music collections. Although more experimentation is needed to answer unaddressed questions like the robustness of the measure to acoustic artifacts that do not affect the audio prompt adherence, the current results suggest that distribution-based embedding distances provide a viable way of measuring audio prompt adherence. An python/pytorch implementation of the proposed measure is publicly available as a github repository.
diff --git a/corpus/music/deltas/96e089c9035c4fea.txt b/corpus/music/deltas/96e089c9035c4fea.txt
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+++ b/corpus/music/deltas/96e089c9035c4fea.txt
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+MusiCRS: Benchmarking Audio-Centric Conversational Recommendation
+
+Conversational recommendation has advanced rapidly with large language models (LLMs), yet music remains a uniquely challenging domain in which effective recommendations require reasoning over audio content beyond what text or metadata can capture. We present MusiCRS, the first benchmark for audio-centric conversational recommendation that links authentic user conversations from Reddit with corresponding tracks. MusiCRS includes 477 high-quality conversations spanning diverse genres (classical, hip-hop, electronic, metal, pop, indie, jazz), with 3,589 unique musical entities and audio grounding via YouTube links. MusiCRS supports evaluation under three input modality configurations: audio-only, query-only, and audio+query, allowing systematic comparison of audio-LLMs, retrieval models, and traditional approaches. Our experiments reveal that current systems struggle with cross-modal integration, with optimal performance frequently occurring in single-modality settings rather than multimodal configurations. This highlights fundamental limitations in cross-modal knowledge integration, as models excel at dialogue semantics but struggle when grounding abstract musical concepts in audio. To facilitate progress, we release the MusiCRS dataset (https://huggingface.co/datasets/rohan2810/MusiCRS), evaluation code (https://github.com/rohan2810/musiCRS), and comprehensive baselines.
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diff --git a/corpus/music/deltas/c804fd37fcb22c6c.txt b/corpus/music/deltas/c804fd37fcb22c6c.txt
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+++ b/corpus/music/deltas/c804fd37fcb22c6c.txt
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+Learning Marmoset Vocal Patterns with a Masked Autoencoder for Robust Call Segmentation, Classification, and Caller Identification
+
+The marmoset, a highly vocal primate, is a key model for studying social-communicative behavior. Unlike human speech, marmoset vocalizations are less structured, highly variable, and recorded in noisy, low-resource conditions. Learning marmoset communication requires joint call segmentation, classification, and caller identification -- challenging domain tasks. Previous CNNs handle local patterns but struggle with long-range temporal structure. We applied Transformers using self-attention for global dependencies. However, Transformers show overfitting and instability on small, noisy annotated datasets. To address this, we pretrain Transformers with MAE -- a self-supervised method reconstructing masked segments from hundreds of hours of unannotated marmoset recordings. The pretraining improved stability and generalization. Results show MAE-pretrained Transformers outperform CNNs, demonstrating modern self-supervised architectures effectively model low-resource non-human vocal communication.
diff --git a/corpus/music/deltas/d100c9eead5d0a53.pdf b/corpus/music/deltas/d100c9eead5d0a53.pdf
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+oid sha256:d100c9eead5d0a5391d5c501dc734362f1416f99d497f33b1a139ae48c16c4b9
+size 604251
diff --git a/corpus/music/deltas/d2a3a5aa5e809b1d.txt b/corpus/music/deltas/d2a3a5aa5e809b1d.txt
new file mode 100644
index 0000000000000000000000000000000000000000..120ae9a70c296dfd1c2ef972d6888a6f00fd7061
--- /dev/null
+++ b/corpus/music/deltas/d2a3a5aa5e809b1d.txt
@@ -0,0 +1,3 @@
+Acoustic intensity estimation using cardioid microphone pairs in tight-frame configurations
+
+This paper investigates acoustic intensity estimation using pairs of cardioid microphones based on the cardioid-cardioid (C-C) method. Unlike conventional pressure-difference techniques, the C-C method is intrinsically less sensitive to the relationship between microphone spacing and acoustic wavelength. However, practical microphones inevitably deviate from ideal cardioid directivity, producing direction-dependent estimation errors. To improve robustness against such errors, a measurement framework based on spherical tight-frame microphone configurations is proposed. Directional intensity components measured along multiple axes are combined to reconstruct the three-dimensional acoustic intensity vector. Furthermore, directivity errors are represented using Legendre polynomial and spherical harmonic expansions, and a geometry-dependent leakage metric is introduced to quantify the error-suppression capability of different microphone arrangements. Theoretical analysis and numerical simulations demonstrate that tight-frame configurations effectively suppress direction-dependent errors through geometric averaging. The proposed leakage metric provides a qualitative indication of microphone directivity imperfections on the reconstructed intensity vector. The results further indicate that accurate wide-band acoustic-intensity estimation can be achieved even with relatively large microphone spacings, which are generally impractical in conventional pressure-difference approaches. The proposed framework provides a physically interpretable and practically useful approach for acoustic intensity measurement using directional microphone arrays.
diff --git a/corpus/music/deltas/e1ca26cb61159a41.pdf b/corpus/music/deltas/e1ca26cb61159a41.pdf
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+version https://git-lfs.github.com/spec/v1
+oid sha256:e1ca26cb61159a41d00bfcaf25b4729862533941a6e91c6ce178d90403658b47
+size 882537
diff --git a/corpus/music/deltas/e33cdc6baf4f4ebd.pdf b/corpus/music/deltas/e33cdc6baf4f4ebd.pdf
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+oid sha256:e33cdc6baf4f4ebdeec347c54f05377eb01a592a20136d1b9adcf6df635acf58
+size 10861751
diff --git a/corpus/music/deltas/e530a4cc3305404f.txt b/corpus/music/deltas/e530a4cc3305404f.txt
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--- /dev/null
+++ b/corpus/music/deltas/e530a4cc3305404f.txt
@@ -0,0 +1,3 @@
+RenCon 2025: Revival of the Expressive Performance Rendering Competition
+
+This paper presents a comprehensive documentation of RenCon 2025, the revival of the expressive performance rendering competition which took place at ISMIR 2025 in Daejeon, Korea. The competition attracted 9 entries from international research groups, representing diverse approaches to expressive piano performance rendering. The two-phase assessment structure comprised a preliminary online evaluation and live real-time rendering at the conference. We analyze the competition format, participant demographics, system performance, and lessons learned for future iterations. The results demonstrate significant advances in expressive rendering capabilities while highlighting remaining challenges in achieving human-level musical expression.
diff --git a/corpus/music/deltas/e7ec53170fc3499f.pdf b/corpus/music/deltas/e7ec53170fc3499f.pdf
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--- /dev/null
+++ b/corpus/music/deltas/e7ec53170fc3499f.pdf
@@ -0,0 +1,3 @@
+version https://git-lfs.github.com/spec/v1
+oid sha256:e7ec53170fc3499fe645967a8c368e66057537202ec4db24030a29765a6755a7
+size 2124746
diff --git a/corpus/music/deltas/ea97a7aa0749bf6d.txt b/corpus/music/deltas/ea97a7aa0749bf6d.txt
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--- /dev/null
+++ b/corpus/music/deltas/ea97a7aa0749bf6d.txt
@@ -0,0 +1,3 @@
+GCDance: Genre-Controlled Music-Driven 3D Full Body Dance Generation
+
+Music-driven dance generation is a challenging task as it requires strict adherence to genre-specific choreography while ensuring physically realistic and precisely synchronized dance sequences with the music's beats and rhythm. Although significant progress has been made in music-conditioned dance generation, most existing methods struggle to convey specific stylistic attributes in generated dance. To bridge this gap, we propose a diffusion-based framework for genre-specific 3D full-body dance generation, conditioned on both music and descriptive text. To effectively incorporate genre information, we develop a text-based control mechanism that maps input prompts, either explicit genre labels or free-form descriptive text, into genre-specific control signals, enabling precise and controllable text-guided generation of genre-consistent dance motions. Furthermore, to enhance the alignment between music and textual conditions, we leverage the features of a music foundation model, facilitating coherent and semantically aligned dance synthesis. Last, to balance the objectives of extracting text-genre information and maintaining high-quality generation results, we propose a novel multi-task optimization strategy. This effectively balances competing factors such as physical realism, spatial accuracy, and text classification, significantly improving the overall quality of the generated sequences. Extensive experimental results obtained on the FineDance and AIST++ datasets demonstrate the superiority of GCDance over the existing state-of-the-art approaches.
diff --git a/corpus/music/deltas/f36be15218f35da0.pdf b/corpus/music/deltas/f36be15218f35da0.pdf
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+++ b/corpus/music/deltas/f36be15218f35da0.pdf
@@ -0,0 +1,3 @@
+version https://git-lfs.github.com/spec/v1
+oid sha256:f36be15218f35da0a5f3ead0a3bc7d7508ccbd1811fae0e16ffd805448e81e53
+size 2292164
diff --git a/corpus/music/deltas/fc779f4d96604864.txt b/corpus/music/deltas/fc779f4d96604864.txt
new file mode 100644
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--- /dev/null
+++ b/corpus/music/deltas/fc779f4d96604864.txt
@@ -0,0 +1,3 @@
+DiffRoll: Diffusion-based Generative Music Transcription with Unsupervised Pretraining Capability
+
+In this paper we propose a novel generative approach, DiffRoll, to tackle automatic music transcription (AMT). Instead of treating AMT as a discriminative task in which the model is trained to convert spectrograms into piano rolls, we think of it as a conditional generative task where we train our model to generate realistic looking piano rolls from pure Gaussian noise conditioned on spectrograms. This new AMT formulation enables DiffRoll to transcribe, generate and even inpaint music. Due to the classifier-free nature, DiffRoll is also able to be trained on unpaired datasets where only piano rolls are available. Our experiments show that DiffRoll outperforms its discriminative counterpart by 19 percentage points (ppt.) and our ablation studies also indicate that it outperforms similar existing methods by 4.8 ppt. Source code and demonstration are available https://sony.github.io/DiffRoll/.
diff --git a/corpus/politics/text/06144a25a5ed918f.txt b/corpus/politics/text/06144a25a5ed918f.txt
new file mode 100644
index 0000000000000000000000000000000000000000..ebf7909d12bf31b07150835ce5d5d0bcfb651711
--- /dev/null
+++ b/corpus/politics/text/06144a25a5ed918f.txt
@@ -0,0 +1,4381 @@
+The Evolution of Cooperative Threat 
+Reduction: Issues for Congress 
+
+ Mary Beth D. Nikitin 
+ Specialist in Nonproliferation 
+
+ Amy F. Woolf 
+ Specialist in Nuclear Weapons Policy 
+
+June 13, 2014 
+
+ Congressional Research Service 
+
+7-5700 
+
+www.crs.gov 
+
+R43143 
+
+ CRS Report for Congress
+ Pr 
+
+ epared for Members and Committees of Congress 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Summary 
+
+The United States uses a number of policy tools to address the threat of attack using chemical, 
+biological, radiological and nuclear (CBRN) weapons. These include a set of financial and 
+technical programs known, variously, as cooperative threat reduction (CTR) programs, 
+nonproliferation assistance, or, global security engagement. Congress has supported these 
+programs over the years, but has raised a number of questions about their implementation and 
+their future direction. 
+
+Over the years, the CTR effort shifted from an emergency response to impending chaos in the 
+Soviet Union to a broader program seeking to keep CBRN weapons away from rogue nations or 
+terrorist groups. It has also grown from a DOD-centered effort to include projects funded by the 
+Department of Defense (DOD), the State Department, the Department of Energy (DOE), and the 
+Department of Homeland Security (DHS). Together, these agencies sought nearly $1.65 billion 
+for these programs in FY2014. 
+
+Although initially focused on the former Soviet Union, these programs now seek to engage 
+partners around the world. The United States has used its funding and expertise to help secure or 
+destroy dangerous weapons and materials in nations that experience civil strife or regime 
+collapse, such as in Libya, and to prevent their spread outside a conflict’s borders, such as with 
+Syria’s neighboring countries. U.S. cooperation with Russia is narrowing, with many of the CTR 
+projects in Russia winding down after the June 2013 expiration of the Memorandum of 
+Understanding that governed DOD’s cooperation with Russia. The two countries will continue to 
+cooperate on some areas of nuclear security with a bilateral protocol under the Multilateral 
+Nuclear Environmental Program in the Russian Federation Agreement (MNEPR). 
+
+In its oversight of these programs, Congress has addressed questions about the coordination of 
+and priority given to these programs, about partner nations’ willingness to provide access to their 
+weapons facilities, and about metrics used to measure progress. Congress has also reviewed 
+efforts to engage nations around the world in cooperative threat reduction and security 
+engagement activities. Some Members have actively encouraged the Obama Administration to 
+expand these programs to the Middle East and North Africa. This goal is evident in the Next 
+Generation Cooperative Threat Reduction Act of 2013 (S. 1021) and the Cooperative Threat 
+Reduction Modernization Act (H.R. 2314). Similar provisions are part of both the House and 
+Senate versions of the National Defense Authorization Act of FY2014 (H.R. 1960, §1304; S. 
+1197, §1326). 
+
+This report summarizes cooperative activities conducted during the full 20 years of U.S. threat 
+reduction and nonproliferation assistance. Many older programs have concluded their work, while 
+more recent programs continue to expand their scope and their geographic reach. 
+
+Several DOD and DOE programs have helped Russia and the other former Soviet states eliminate 
+nuclear weapons delivery systems and secure nuclear warheads in storage. DOE has also helped 
+Russia strengthen security and materials accounting at facilities that store nuclear materials. 
+These agencies are seeking to expand this effort to other nations by sharing “best practices” with 
+partner countries through Centers of Excellence. DOE is also working, through the Global Threat 
+Reduction Initiative (GTRI), to secure, protect, and in some cases, remove vulnerable nuclear and 
+radiological materials at civilian facilities worldwide. 
+
+ Congressional Research Service 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+DOD has also helped Russia secure and eliminate chemical weapons by supporting the design 
+and construction of a chemical weapons destruction facility at Shchuch’ye. DOD and the State 
+Department also provide assistance to address concerns about the proliferation of pathogens that 
+might be used in biological weapons. DOD’s biological threat reduction program now accounts 
+for nearly 60% in the FY2014 budget request. It also has grown from a program focused on 
+dismantling the vast biological weapons complex in Russia into a tool used to promote “best 
+practices” at biological laboratories with dangerous pathogens and to develop disease surveillance 
+systems on several continents, particularly Southeast Asia and sub-Saharan Africa. 
+
+The United States also supports global programs that are designed to prevent the smuggling or 
+illegal export of CBRN materials and technology. The State Department and DOE have also 
+developed programs that are designed to reduce the risk that the weapons scientists would sell 
+their knowledge to nations seeking their own CBRN weapons. These programs seek to prevent 
+terrorists from exploiting scientists, other personnel, or materials to develop these weapons. The 
+programs also train not only scientists, but other lab personnel about international security 
+standards and improve personnel reliability programs to address the “insider threat.” 
+
+This report will be updated as needed. 
+
+ 
+
+ Congressional Research Service 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Contents 
+
+Introduction ...................................................................................................................................... 1 
+Background ...................................................................................................................................... 2 
+
+The Nunn-Lugar Amendment .................................................................................................... 2 
+An Evolving Program ................................................................................................................ 3 
+
+Threat Reduction and Nonproliferation .............................................................................. 3 
+Nonproliferation and Counterterrorism ............................................................................... 3 
+Global Security Engagement ............................................................................................... 4 
+The Future of Cooperation with Russia .............................................................................. 6 
+Threat Reduction After Regime Collapse ........................................................................... 8 
+Threat Reduction in the Middle East and North Africa ....................................................... 9 
+
+Agency Participation ................................................................................................................. 9 
+
+Department of Defense (DOD) ......................................................................................... 10 
+Department of Energy (DOE) ........................................................................................... 10 
+The State Department ........................................................................................................ 11 
+Department of Homeland Security (DHS) ........................................................................ 12 
+
+Issues for Congress ........................................................................................................................ 12 
+
+Coordination Across Government Agencies ............................................................................ 12 
+Priority Within the Executive Branch ...................................................................................... 14 
+Measuring Success and Metrics .............................................................................................. 15 
+Access and Transparency ........................................................................................................ 17 
+International Cooperation—The G-8 Global Partnership ........................................................ 18 
+
+The Programs ................................................................................................................................. 20 
+
+Securing and Eliminating Nuclear Weapons ........................................................................... 20 
+
+Strategic Offensive Arms Elimination ............................................................................... 20 
+Global Nuclear Security .................................................................................................... 22 
+Warhead Security and the Department of Energy ............................................................. 24 
+
+Securing and Eliminating Nuclear Materials ........................................................................... 26 
+
+CTR Fissile Materials Storage .......................................................................................... 26 
+DOE Nuclear Materials Security Programs ...................................................................... 27 
+Nuclear Security Centers of Excellence ............................................................................ 29 
+Global Threat Reduction Initiative (GTRI) ....................................................................... 30 
+
+Securing Borders and Improving Export Controls .................................................................. 32 
+
+Export Control and Related Border Security Assistance ................................................... 32 
+Nuclear Smuggling Outreach Initiative (NSOI) ................................................................ 33 
+Proliferation Prevention .................................................................................................... 33 
+Second Line of Defense .................................................................................................... 34 
+Container Security Initiative and Secure Freight Initiative ............................................... 35 
+
+Chemical Weapons Destruction ............................................................................................... 35 
+Cooperative Biological Engagement ....................................................................................... 37 
+
+Biological Threat Reduction (BTR) in Russia .................................................................. 38 
+Central Asia and the Caucuses .......................................................................................... 39 
+Global Cooperative Biological Engagement (CBE).......................................................... 40 
+
+Funding .......................................................................................................................................... 41 
+
+Securing Knowledge and Expertise ......................................................................................... 42 
+
+The Science Centers .......................................................................................................... 43 
+Iraq and Libya Scientist Engagement Programs ............................................................... 44 
+
+ Congressional Research Service 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+Department of Energy Programs ....................................................................................... 44 
+
+ 
+
+ Tables 
+
+Table 1. CTR Funding for Strategic Offensive Arms Elimination (SOAE) ................................... 21 
+Table 2. CTR Funding for Transportation Security ....................................................................... 23 
+Table 3. DOD and DOE Authorizations for Warhead Storage Security Programs ........................ 26 
+Table 4. CTR Authorizations for Fissile Materials Storage ........................................................... 27 
+Table 5. DOE Authorizations for Nuclear Materials Security Programs ....................................... 28 
+Table 6. DOE Authorizations for Global Threat Reduction Initiative ........................................... 30 
+Table 7. DOE Funding for Second Line of Defense and Megaports ............................................. 35 
+Table 8. CTR Funding for Chemical Weapons Destruction........................................................... 37 
+Table 9. CTR Funding for Cooperative Biological Engagement ................................................... 42 
+Table A-1. Department of Defense Cooperative Threat Reduction Program ................................ 48 
+Table A-2. Department of State Programs ..................................................................................... 48 
+Table A-3. Department of Energy Defense Nuclear Nonproliferation Programs .......................... 49 
+Table A-4. Department of Homeland Security Programs .............................................................. 49 
+Table B-1. Title XIII, National Defense Authorization Acts FY2001-FY2013 ............................. 50 
+
+ 
+
+ Appendixes 
+
+Appendix A. Funding Requests, by Agency .................................................................................. 48 
+Appendix B. Major Provisions in Cooperative Threat Reduction Legislation .............................. 50 
+
+ 
+
+ Contacts 
+
+Author Contact Information........................................................................................................... 52 
+
+ 
+
+ Congressional Research Service 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Introduction 
+
+Many experts have postulated that the threat of attack with chemical, biological, radiological and 
+nuclear (CBRN) weapons represents one of the greatest threats to U.S. national security. There is 
+widespread agreement—within the U.S. government, among national security policy analysts, 
+and across the political spectrum—that the United States faces a growing threat from the potential 
+use of these weapons by hostile nations and terrorist groups. Many in Congress have also 
+expressed concerns about the potential terrorist use of CBRN weapons and have supported U.S. 
+efforts to address and mitigate this threat. 
+
+President George W. Bush highlighted this threat in his 2002 National Strategy to Combat 
+Weapons of Mass Destruction. This report opened with the observation that “weapons of mass 
+destruction (WMD)—nuclear, biological, and chemical—in the possession of hostile states and 
+terrorists represent one of the greatest security challenges facing the United States. We must 
+pursue a comprehensive strategy to counter this threat in all of its dimensions.”1 President Obama 
+offered a similar warning in his 2010 National Security Strategy, when he noted that “there is no 
+greater threat to the American people than weapons of mass destruction, particularly the danger 
+posed by the pursuit of nuclear weapons by violent extremists and their proliferation to additional 
+states.”2 
+
+The United States uses a range of policy tools to address the threats posed by the potential spread 
+of nuclear, chemical, and biological weapons to hostile nations or non-state actors. These range 
+from diplomatic engagement and economic sanctions to the threat of military intervention. One 
+key set of tools is a set of financial and technical programs known, variously, as cooperative 
+threat reduction programs, nonproliferation assistance, or, global security engagement. Through 
+these programs, the United States seeks to work with other nations to help them secure and 
+eliminate their CBRN weapons and material, to stem the flow of weapons and related knowledge 
+and materials to hostile nations or non-state actors who might seek to develop their own weapons, 
+and to develop training programs and share “best practices” to ensure that other nations can 
+protect the materials and knowledge that remain in their countries. 
+
+Many of the programs that are funded through these efforts evolved out of an initiative that 
+Congress created in late 1991. After an August 1991 coup in Moscow led to concerns about the 
+potential loss of control over Soviet nuclear weapons, Congress passed the Nunn-Lugar 
+amendment and authorized the use of up to $400 million in funds in the Department of Defense 
+(DOD) budget to help safely secure, transport, and eliminate Soviet nuclear weapons. This 
+initiative grew over the years, such that the United States spent around $1.65 billion in FY2013 
+on programs that have sought to secure and eliminate nuclear, chemical, and biological weapons 
+and materials in the former Soviet states; enhance border security and export controls to deter and 
+detect efforts to transport these materials across state lines; secure and eliminate nuclear, 
+chemical, or biological materials in nations outside the former Soviet Union; and redirect 
+weapons scientists in many nations around the world so that they will pursue programs with 
+
+ 
+
+1 The White House, National Strategy to Combat Weapons of Mass Destruction , Washington, D.C., December 2002, p. 
+1, http://www.fas.org/irp/offdocs/nspd/nspd-wmd.pdf. 
+2 The White House, National Security Strategy , Washington, D.C., May, 2010, p. 4, http://www.whitehouse.gov/sites/
+default/files/rss_viewer/national_security_strategy.pdf. 
+
+ Congressional Research Service 
+
+ 1 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+peaceful purposes. This funding has, however, begun to decline, falling to $1.59 billion in 
+FY2014, and a requested $1.25 billion in FY2015. In addition, these programs are now funded 
+and administered by DOD, the Department of Energy (DOE), the State Department, the 
+Department of Homeland Security (DHS), and several other U.S. agencies. 
+
+Over the years, Congress has offered significant support to these efforts. It has not only 
+authorized and appropriated increasing sums for these programs, it has generally agreed with the 
+executive branch on the priorities and goals for them. Nevertheless, over the years, some 
+Members have questioned the value of specific goals and the effectiveness of some projects. 
+Congress has adjusted the profile of these programs over the years, sometimes reducing funds, 
+sometimes increasing funds, and sometimes initiating new programs and project areas. The 113th 
+Congress is likely to continue to review the funding for these programs, consider the goals, and 
+assess their effectiveness. Moreover, Congress may continue to raise questions about the future 
+intent of these programs, the success of government-wide coordination in implementing them, 
+and the extent of international cooperation in addressing these threats. These questions may be 
+amplified in the future, as the United States and Russia have wrapped up their cooperation on a 
+number of threat reduction and nonproliferation projects after the June 2013 expiration of the 
+umbrella agreement governing many of these programs.3 
+
+This report provides information on the wide range of programs that the United States is pursuing 
+to secure and eliminate nuclear, chemical, and biological weapons and materials and to prevent 
+hostile nations and terrorist organizations from gaining access to these weapons or the knowledge 
+and materials needed to manufacture and use them. It begins with a brief review of the evolution 
+of these programs, demonstrating how the goals and objectives have changed over the years. It 
+also reviews some of the issues that Congress may confront as it seeks to provide oversight of 
+these programs and reviews budget requests for them. The report then provides information on 
+individual programs that are designed to secure and eliminate nuclear weapons, secure and 
+eliminate nuclear materials, secure borders and improve export controls, eliminate chemical 
+weapons, secure biological pathogens, and redirect scientists with knowledge of CBRN weapons.. 
+
+ Background 
+
+ The Nunn-Lugar Amendment 
+
+Congress initiated U.S. threat reduction and nonproliferation assistance to the Soviet Union in 
+November 1991. A failed coup in Moscow in August 1991 and the subsequent disintegration of 
+the Soviet Union had raised concerns about the safety and security of Soviet nuclear weapons. 
+Consequently, Senators Sam Nunn and Richard Lugar proposed an amendment to the 
+implementing legislation for the Conventional Armed Forces in Europe (CFE) Treaty (P.L. 102-
+228). This amendment, titled the “Soviet Nuclear Threat Reduction Act of 1991,” authorized the 
+use of $400 million in FY1992 Defense Department (DOD) funds to assist the Soviet Union, and 
+its “successor entities” with efforts to “1) destroy nuclear weapons, chemical weapons, and other 
+
+ 
+
+3 The agreement expired on June 16, 2013. A new agreement covers a more narrow set of programs, and is likely to 
+exclude most projects funded by DOD. See Jordana Mishory, “Creedon: New Agreement with Russia Needed to 
+Preserve CTR Programs,” Inside the Pentagon , May 22, 2013, pp. http://insidedefense.com/Inside-the-Pentagon/Inside-
+the-Pentagon-05/23/2013/creedon-new-agreement-with-russia-needed-to-preserve-ctr-programs/menu-id-80.html. 
+
+ Congressional Research Service 
+
+ 2 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+weapons, 2) transport, store, disable, and safeguard weapons in connection with their destruction, 
+and 3) establish verifiable safeguards against the proliferation of such weapons.”4 This effort 
+became known as the Cooperative Threat Reduction (CTR) Program. 
+
+ An Evolving Program 
+
+ Threat Reduction and Nonproliferation 
+
+Initially, many in Congress saw U.S. assistance under the CTR program as an emergency 
+response to impending chaos in the Soviet Union. Senators arguing in support of the program, 
+including Senators Nunn and Lugar, noted that the disintegration of the Soviet Union created “the 
+danger that the ultimate disposition of nuclear weapons in the new political system will not be 
+conducive to their safety or international stability.” They warned of “a danger of seizure, theft, 
+sale or use of nuclear weapons or components” and argued that “any weakening of control over 
+weapons and components could spill outside the territory of the former Soviet Union, fueling 
+nuclear proliferation worldwide.”5 Senator Nunn further warned that “we are on the verge of 
+either having the greatest destruction of nuclear weapons in the history of the world or the 
+greatest proliferation of nuclear weapons, nuclear materials, and scientific know-how on how to 
+make these weapons, as well as chemical weapons, ballistic missiles, even biological weapons the 
+world has ever seen.”6 
+
+Even after the sense of immediate crisis passed in 1992 and 1993, many analysts and Members of 
+Congress remained concerned about the potential for diversion or a loss of control of Russia’s 
+nuclear and other weapons. Russia’s economy was extremely weak and press accounts reported 
+that nuclear materials from Russia were appearing on the black market in Western Europe. 
+Consequently, many began to view CTR as a part of a long-term threat reduction and 
+nonproliferation effort. Former Secretary of Defense William Perry referred to CTR as “defense 
+by other means,”7 as the program helped eliminate Soviet weapons that had threatened the United 
+States and contain weapons and materials that could pose new threats in the hands of other 
+nations. 
+
+ Nonproliferation and Counterterrorism 
+
+By the mid-1990s, many observers also began to view U.S. assistance to the former Soviet states 
+as a part of the effort to keep weapons of mass destruction away from terrorists. In 1996, experts 
+testified to Congress that Russian nuclear and chemical facilities, with their crumbling security 
+and lack of accounting procedures, could provide a source for terrorists seeking nuclear or 
+chemical materials. In response, Congress expanded the programs that provided security at 
+facilities with nuclear materials and suggested that more attention be paid to security at facilities 
+with materials that could be used in chemical or biological weapons.8 
+
+ 
+
+4 For more information on this legislation, see CRS Report 94-985, The Nunn-Lugar Program for Soviet Weapons 
+Dismantlement: Background and Implementation , by Theodor Galdi. (Available from Amy F. Woolf, on request.) 
+5 See the comments of Senator Richard Lugar in the Congressional Record, November 25, 1991. p. S18005. 
+6 Ibid., p. S18004. 
+7 See, for example, U.S. Department of Defense. Cooperative Threat Reduction. April 1995. Washington, DC, p. 1. 
+8 The March 1995 nerve agent attack in the Tokyo subway system by the Aum Shinryo cult raised the profile of this 
+(continued...) 
+
+ Congressional Research Service 
+
+ 3 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+In January 2001, a task force sponsored by the Department of Energy stated that “the most urgent 
+unmet national security threat to the United States today is the danger that weapons of mass 
+destruction or weapons-usable materials in Russia could be stolen and sold to terrorists or hostile 
+nation states and used against American troops abroad or citizens at home.”9 Since September 11, 
+2001, virtually all analysts who follow U.S. threat reduction and nonproliferation assistance have 
+argued that, by helping Russia protect its weapons, related materials, and knowledge, the United 
+States could make it more difficult for terrorists to acquire CBRN weapons.10 
+
+The George W. Bush Administration clearly considered U.S. threat reduction and nonproliferation 
+programs in the former Soviet states to be a part of U.S. efforts to keep weapons of mass 
+destruction away from terrorists, explaining, in early 2003, that it had “expanded the strategic 
+focus of the CTR program” to support the war on terrorism.11 In its budgets presented in the years 
+after FY2004, the Administration increased funding for several export and border control 
+programs, for programs designed to stem the leakage of knowledge out of the former Soviet 
+Union, and for an effort to find and recover “radiological sources”—a type of device that could 
+provide terrorists with nuclear materials for use in a “dirty bomb.”12 
+
+All of these initiatives focused more on stemming proliferation than on eliminating nuclear 
+weapons in the former Soviet states. But the programs did not completely lose the initial focus. 
+During a February 2005 summit in Bratislava, Presidents Bush and Vladimir Putin agreed to 
+accelerate some of the efforts to secure Soviet-era nuclear weapons. This agreement shifted 
+additional funding into some of the DOD CTR projects and hastened the completion of some 
+warhead storage and security efforts. As a result, in the years leading up to the 2013 expiration of 
+the agreement governing these programs, U.S. threat reduction and nonproliferation programs in 
+Russia completed much of the work focused on eliminating retired Soviet-era nuclear weapons 
+delivery systems, transporting and securing nuclear warheads, and paving the way for the 
+destruction of Soviet-era chemical weapons. 
+
+ Global Security Engagement 
+
+Over the past decade, U.S. threat reduction and nonproliferation programs have expanded beyond 
+the borders of the former Soviet Union, as the United States has sought to secure and eliminate 
+nuclear, chemical, and biological materials around the world by working with a diverse set of 
+countries to build capacity on nuclear security, biological pathogen security, and border security. 
+ 
+(...continued) 
+type of threat. 
+9 The report went on to state that “unless protected from theft of diversion, the former Soviet arsenal of weapons of 
+mass destruction threatens to become a goldmine for would-be proliferators the world over.” Baker, Howard and Lloyd 
+Cutler, Co-Chairs, Russia Task Force. A Report Card on the Department of Energy’s Nonproliferation Programs with 
+Russia. The Secretary of Energy Advisory Board, United States Department of Energy. January 10, 2001. p. 1. 
+10 Senator Sam Nunn has stated that “Preventing the spread and use of nuclear biological, and chemical weapons and 
+materials should be the central organizing principle on security for the 21st century.” Remarks by Former U.S. Senator 
+Sam Nunn, Chairman, Nuclear Threat Initiative. Carnegie Endowment for International Peace. International 
+Nonproliferation Conference. November 14 , 2002. 
+11 U.S. Department of Defense. Fiscal Year 2004/2005 Biennial Budget Estimates. Former Soviet Union Threat 
+Reduction Appropriation. February 2003. p. 1. 
+12 Many analysts believe that this type of weapon, which could disperse radioactive materials across a wide area, might 
+be particularly attractive to terrorists. For details see CRS Report R41891, ”Dirty Bombs”: Background in Brief , by 
+Jonathan E. Medalia. 
+
+ Congressional Research Service 
+
+ 4 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+This is done through a combination of training programs and equipment, the majority of which is 
+provided to non-nuclear-weapon states. 
+
+The Obama Administration endorsed the expansion of these programs, noting that they could help 
+contain proliferation and reduce the threat from terrorists who might seek CBRN weapons. 
+According to Administration officials, these programs are designed to keep these weapons “out of 
+the hands of terrorists and states of concern, [to lock down] dangerous nuclear and biological 
+materials, [to eliminate] chemical weapons, [to destroy] legacy weapons, and [to build] 
+capabilities and conduct operations to prevent acquisition, contain and roll back threats, and 
+respond to [CBRN] crises.”13 President Obama specifically placed a priority on securing 
+vulnerable nuclear materials worldwide, and has both engaged international partners through the 
+Nuclear Security summit process and accelerated funding for the Global Threat Reduction 
+Initiative (GTRI) with this goal in mind. 
+
+Funding requests have demonstrated the new priorities, with support for programs that move 
+beyond the program’s historical base in the former Soviet Union. Nations in Africa, the Middle 
+East, South Asia, and Southeast Asia can now participate in cooperative programs supported by 
+this funding. According to the Obama Administration, in 2013, DOD was “now funding roughly 
+as much work outside of the former Soviet Union as we are inside the former Soviet Union.” Its 
+goal is to increase “the flexibility of the program to be successful as a global effort.”14 
+
+While many in Congress now support this global expansion of U.S. threat reduction and 
+nonproliferation programs, Congress took several years to approve this new authority. For 
+example, during the debate over the FY2003 Defense Authorization Bill, the Senate approved an 
+amendment, proposed by Senator Richard Lugar, that would allow DOD to use up to $50 million 
+in FY2003 CTR funds “outside the states of the former Soviet Union” to resolve “critical 
+emerging proliferation threats and to take advantage of opportunities to achieve long-standing 
+United States nonproliferation goals.”15 The Bush Administration supported Senator Lugar’s 
+proposal but the House objected and the language was removed in conference. The Bush 
+Administration requested the same authority the following year and the Senate again offered its 
+unqualified support, but many in the House again objected. The conference committee included 
+the authority to spend $50 million in CTR funds outside the former Soviet Union in the FY2004 
+Defense Authorization Act (P.L. 108-136), but, indicated that this funding could be used only for 
+short-term projects. The Bush Administration exercised this authority for the first time in mid-
+2004, when it provided assistance to Albania for the elimination of chemical weapons.16 
+
+Congressional support for the expansion of these programs had grown more wide-spread by the 
+end of the Bush Administration. For example, in the FY2008 Defense Authorization Act (P.L. 
+110-181, §1306), Congress indicated that CTR should be “strengthened and expanded, in part by 
+developing new CTR initiatives.” It suggested that these new initiatives could include “programs 
+and projects in Asia and the Middle East; and activities relating to the denuclearization of the 
+Democratic People’s Republic of Korea.” Congress added $10 million to the CTR authorization 
+
+ 
+
+13 U.S. Congress, Senate Armed Services, Emerging Threats and Capabilities, Proliferation Prevention Programs , 
+Hearing, 113th Cong., 1st sess., April 23, 2013. Testimony of Madelyn R. Creedon, Assistant Secretary of Defense, 
+Global Strategic Affairs. 
+14 Ibid. 
+15 S. 2026, H.R. 4546, §1203. 
+16 Warrick, Joby. Albania’s Chemical Cache Raises Fears About Others. Washington Post . January 10, 2005. p. A1. 
+
+ Congressional Research Service 
+
+ 5 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+to fund these programs, streamlined the process of identifying and approving projects, and 
+eliminated the requirement that limited the program to short-term projects that addressed sudden, 
+emergency proliferation concerns. Congress also mandated that the National Academy of 
+Sciences conduct a study “to analyze options for strengthening and expanding the CTR Program.” 
+When it released the required report in 2009, the National Academy recommended that the United 
+States use a new, broader CTR program to engage nations around the world in a global effort to 
+secure dangerous weapons and materials.17 It also suggested that Congress authorize DOD to 
+accept funds from other nations for use in CTR efforts. The FY2010 Defense Authorization Bill 
+included this provision. The Obama Administration supported these efforts and its budget request 
+for FY2011 included funds for this purpose in several program areas. 
+
+Some Members of Congress have actively encouraged the Obama Administration to expand 
+cooperative threat reduction efforts in the Middle East and North Africa. Senator Jeanne Shaheen 
+introduced the “Next Generation Cooperative Threat Reduction Act of 2013” (S. 1021) and 
+Representative Jeff Fortenberry introduced the Cooperative Threat Reduction Modernization Act 
+(H.R. 2314). Both of these bills direct the Administration to provide a strategy for the expansion 
+of CTR programs in the Middle East and North Africa. Similar provisions are part of both House 
+and Senate versions of the National Defense Authorization Act of FY2014 (H.R. 1960, §1304; S. 
+1197, §1326). 
+
+ The Future of Cooperation with Russia 
+
+While the United States has broadened and deepened its nonproliferation and security 
+engagement with nations outside the former Soviet Union, it has scaled back, and, in some cases, 
+concluded, programs of cooperation with Russia. Some of these changes have occurred because 
+ongoing projects were completed or because Russia had the resources to manage the programs on 
+its own. However, more significant changes to the future of U.S.-Russian nonproliferation 
+cooperation derive from the June 17, 2013, expiration of the long-standing Memorandum of 
+Understanding, known as the “umbrella agreement,” that has governed these programs since 
+1992. This agreement provided the legal framework that allowed for program implementation. 
+
+Reports indicate that the United States presented Russia with a draft extension of the umbrella 
+agreement in mid-2012. This draft contained most of the same provisions as the original 
+agreement, which was signed at a time when Russia lacked the financial resources and political 
+will to secure its nuclear weapons and materials on its own. Russia is not only able to finance 
+many of these programs itself now, but according to some observers, is more than willing to do 
+so.18 Moreover, Russian officials seemed to be unwilling to allow U.S. contractors access to 
+sensitive Russian military facilities, even if that meant that Russia would no longer have access to 
+U.S. financial resources. As a result, in early October 2012, Russian officials indicated that they 
+were prepared to allow the agreement to lapse and to conclude the programs. In a report for 
+Congress prepared in March 2013, the Pentagon indicated that, without adequate legal protections 
+in a new agreement, the United States would have to begin to shut down some of the ongoing 
+projects.19 
+
+ 
+
+17 National Academy of Sciences, Global Security Engagement: A New Model for Cooperative Threat Reduction , 
+Washington, DC, April 2009. 
+18 Douglas Birch, “Letting Go of “Loose Nukes,” Foreign Policy , October 31, 2012. 
+19 Jordana Mishory, “Creedon: New Agreement with Russia Needed to Preserve CTR Programs,” Inside the Pentagon , 
+May 22, 2013, pp. http://insidedefense.com/Inside-the-Pentagon/Inside-the-Pentagon-05/23/2013/creedon-new-
+(continued...) 
+
+ Congressional Research Service 
+
+ 6 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+After the United States and Russia failed to reach an agreement on the extension of the original 
+umbrella agreement, they agreed to continue cooperation under a bilateral protocol to the 
+Multilateral Nuclear Environmental Program in the Russian Federation (MNEPR) Agreement. 
+The MNEPR was negotiated to allow European partners to give funds to nonproliferation and 
+radiological clean-up projects in Russia under the G-8 Global Partnership. The United States 
+signed the MNEPR agreement in 2003, but did not sign the associated Protocol on Claims, Legal 
+Proceedings and Indemnification, since the preexisting CTR umbrella agreement covered those 
+issues already. Nine countries as well as several European institutions20 have used this protocol 
+for liability protection and tax exemption for threat reduction assistance in Russia for the past 
+decade. These protections apply to the United States now, since it signed such a MNEPR protocol 
+with Russia on June 14, 2013. 
+
+In a fact sheet released on June 19, 2013, the State Department noted that the United States and 
+Russia will continue to cooperate “in a broad array of nuclear security and nonproliferation 
+areas.” These will include, but are not limited to 
+
+• improving security of nuclear and radiological material; 
+• customs control of nuclear and radioactive material; 
+• recovery and securing of radioactive sources; 
+• consolidation of nuclear material and conversion of excess highly enriched 
+
+uranium (HEU) to low enriched uranium (LEU); 
+
+• conversion of HEU research reactors to operate with LEU; and 
+• nuclear submarine dismantlement.21 
+
+Russia’s Ministry of Defense will not participate in projects under this agreement, and, as a result, 
+the United States and Russia will no longer cooperate on projects that eliminate strategic 
+offensive arms or transport and secure nuclear warheads. According to the State Department fact 
+sheet, “Russia will now take full responsibility over this mission.” Projects in both areas were 
+already winding down after many years of successful cooperation. At the same time, the United 
+States will continue to monitor Russia’s deployed strategic offensive forces under the 2010 New 
+START Treaty. The United States and Russia also will not continue ongoing projects designed to 
+eliminate chemical weapons, although the State Department indicated that the United States and 
+Russia “continue to discuss potential technical cooperation on chemical weapons destruction 
+outside the new framework.”22 
+
+The Department of Energy, however, will continue to cooperate with its counterpart in Russia, 
+Rosatom, to secure Russian nuclear facilities and materials. As is noted below, DOE programs 
+that enhance security at Russian warhead storage facilities have ended, in part because of the 
+
+ 
+(...continued) 
+agreement-with-russia-needed-to-preserve-ctr-programs/menu-id-80.html. 
+20 MNEPR instruments of ratifications are managed by the OECD’s Nuclear Energy Agency. http://www.oecd-nea.org/
+law/mnepr-ratification.html 
+21 U.S. Department of State, A New Legal Framework for U.S.-Russian Cooperation in Nuclear Nonproliferation 
+Security , Fact Sheet, Washington, D.C., June 19, 2013, http://www.state.gov/r/pa/prs/ps/2013/06/210913.htm. 
+22 The largest of these projects, the construction of a chemical weapons destruction facility at Shchuch’ye is described 
+on page 26, below. 
+
+ Congressional Research Service 
+
+ 7 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+conclusion of the work and in part because of the lapse in cooperation with Russia’s Ministry of 
+Defense. Recently, however, some in Congress have questioned whether the remaining projects 
+should continue, in light of Russia’s aggression against Ukraine. In its version of the FY2015 
+National Defense Authorization Act (H.R. 4435, Secs. 1303 and 3120), the House specified that 
+neither DOD nor DOE could spend funds authorized for threat reduction and nonproliferation 
+cooperation in Russia until the Secretaries of Defense or Energy certified that Russian forces 
+were no longer occupying areas of Ukraine and that Russia was in full compliance with its arms 
+control obligations under the Intermediate Range Nuclear Forces (INF) Treaty and the 
+Conventional Armed Forces in Europe (CFE) Treaty. 
+
+ Threat Reduction After Regime Collapse 
+
+The United States government has grown increasingly concerned about its ability to address the 
+security of stocks of weapons of mass destruction and the facilities that produce them in the event 
+of a regime collapse in countries where such capabilities exist. This scenario presented itself 
+during regime transitions in Libya and Iraq, and is now evident in the international efforts to 
+remove chemical weapons from Syria. North Korea has also been discussed as a possible future 
+scenario should its regime collapse, or should the current government agree to disarmament 
+measures. The concern over loss of control of WMD during conflict or regime change is the same 
+concern that motivated the original CTR programs in the former Soviet Union. Providing 
+assistance in these cases can be difficult, primarily because CTR and related nonproliferation 
+programs are not designed work in a non-cooperative environment; they require the agreement of 
+the host country. 
+
+Libya and Iraq provide two examples of CTR during a time of transition. In Libya, the 
+dismantlement process after Libya became a party to the Conventional Weapons Convention 
+(CWC) in 2004 was initially cooperative with the agreement of the regime. In 2011, after the fall 
+of the Qaddafi regime, the chemical stocks were first secured by forces aligned with the United 
+States. Later, the new government in Libya agreed to work with the Organization for the 
+Prohibition of Chemical Weapons (OPCW),23 to complete the destruction of CW stocks. In Iraq, 
+much of the dismantlement work had been accomplished by the United Nations inspectors prior 
+to Operation Iraqi Freedom in 2003, and stockpiles and capacity turned out to have been 
+overestimated. As described above, a major focus of CTR and nonproliferation programs in both 
+Iraq and Libya has been engaging former WMD weapons scientists in civilian projects to prevent 
+the proliferation of their expertise. 
+
+The Syrian case may be the first time the international community has faced a protracted civil war 
+in a state with a known stockpile of chemical weapons. Due to the threat of access to these 
+weapons by unauthorized groups including terrorists, the United States government had been 
+preparing for scenarios to secure the weapons in the event of the loss of control by the Assad 
+regime. U.S. officials, however, noted the extreme difficulty of accomplishing that goal, which 
+would have probably required ground troops.24 Therefore, instead the United States focused on 
+
+ 
+
+23 The OPCW was established by the Chemical Weapons Convention, and is tasked with assisting countries with the 
+elimination of chemical weapons stockpiles and chemical weapons production facilities subject to the verification 
+measures provided for in the Convention. 
+24 In testimony before the Senate Armed Services Committee on March 7, 2012, Secretary of Defense Panetta said, 
+“It’s 100 times worse than what we dealt in with in Libya. And for that reason, that’s why it’s raised even greater 
+concerns about our ability to address how we can secure those sites.” 
+
+ Congressional Research Service 
+
+ 8 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+working with neighboring countries to bolster their border controls to prevent proliferation of 
+these weapons and materials from Syria. 
+
+Since the Syrian government made the decision in September 2013 to join the Chemical Weapons 
+Convention and destroy its chemical weapons programs, the United States has been providing 
+technical and financial support to the international community to destroy Syrian chemical 
+weapons stocks under international supervision.25 This is a unique case for the CTR program 
+since the primary U.S. threat reduction work—destruction of Syrian chemical weapons—will be 
+done outside of the country itself. Details on U.S. efforts on Syrian chemical weapons destruction 
+are detailed below in “Chemical Weapons Destruction.” 
+
+ Threat Reduction in the Middle East and North Africa 
+
+Some in Congress have advocated dedicating more funds to regions of concern and prioritizing 
+work in the Middle East and North Africa. In the FY2014 Defense Authorization bill (P.L. 113-
+66), Congress mandated that the Administration produce a strategy for “a strategy and 
+implementation plan for preventing the proliferation of weapons of mass destruction and related 
+materialsin the Middle East and North Africa not later than March 31, 2014.” The Administration 
+did provide a strategy report to key congressional committees as mandated, but the report has not 
+been made public. S.Rept. 113-44 said that: 
+
+The Middle East and North Africa (MENA) region represents a new generation of immediate 
+and growing WMD-related proliferation challenges. Factors lending urgency to regional 
+threat dynamics in this region include Syria’s chemical weapons program, Iran’s nuclear 
+program and the influence of terrorist groups operating in the region. The Committee 
+believes that it is critical that the United States develop a comprehensive, effective and 
+efficient cooperative threat reduction (CTR) and nonproliferation strategy to address the 
+challenge of WMD-related proliferation in the MENA region. 
+
+Senator Jeanne Shaheen introduced a bill, the Next Generation Cooperative Threat Reduction Act 
+of 2013 (S. 1021), in May 2013. This bill proposed a multiyear assistance strategy to coordinate 
+and advance CTR and related nonproliferation efforts in the Middle East and North Africa. These 
+efforts may have been in part inspired by a chapter in a January 2013 jointly authored, non-
+governmental report titled “U.S. Nonproliferation Strategy in a Changing Middle East,” which 
+recommended a redirection of CTR efforts to that region.26 
+
+ Agency Participation 
+
+When Congress passed the Nunn-Lugar Amendment in 1991, it authorized the use of $400 
+million from the Defense Department budget to fund U.S. threat reduction assistance to the 
+former Soviet states. Experts from other agencies, such as the State Department and Department 
+of Energy, participated in the projects when their expertise was required. In FY1997, as the 
+programs expanded and funding increased, these agencies each took budgetary and management 
+responsibility for the projects that relied on their expertise. The overwhelming majority of the 
+funding for U.S. threat reduction, nonproliferation, and cooperative engagement programs now 
+resides in the Department of Defense (DOD), Department of Energy (DOE), and Department of 
+ 
+
+25 CRS Report R42848, Syria’s Chemical Weapons: Issues for Congress , coordinated by Mary Beth D. Nikitin. 
+26 http://isis-online.org/uploads/isis-reports/documents/FinalReport.pdf. 
+
+ Congressional Research Service 
+
+ 9 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+State. The Department of Homeland Security also participates with some programs designed to 
+deter or detect efforts to ship nuclear or radiological materials into the United States. Together, 
+these agencies are seeking nearly $1.65 billion for these programs in FY2014.27 
+
+ Department of Defense (DOD) 
+
+According to the CTR program’s budget request for FY2015, the CTR programs “overarching 
+mission” is to work with other countries “to reduce the threat from weapons of mass destruction 
+(WMD) and related materials, technologies, facilities, and expertise.” The program “focuses on 
+eliminating, securing, or consolidating” weapons, materials, delivery systems, and infrastructure 
+in these “partner countries.” DOD further indicates that the program “focuses on eliminating, 
+securing, and consolidating WMD, related materials, and associated delivery systems and 
+infrastructure at their source in partner countries” and in “building partner capacity to prevent the 
+proliferation of WMD materials in transit across international borders.” 28 DOD divides the 
+projects funded by the CTR program into several categories, including strategic offensive arms 
+elimination, chemical weapons destruction, global nuclear security, cooperative biological 
+engagement, and proliferation prevention. These program areas are described in more detail 
+below. 
+
+DOD has requested $365.1 million for the CTR program in FY2015. This represents a decrease 
+of $144.1 million from the FY2014 estimate of $500 million.29 As discussed below, a significant 
+portion of this reduction comes from the conclusion of strategic offensive arms elimination and 
+chemical weapons elimination programs in Russia. Some of the reductions also reflect the 
+conclusion of programs in other countries. For example, according to DOD, the $71 million 
+reduction in funding for the Proliferation Prevention program represents “the anticipated 
+completion of work supporting the Jordan border security surveillance network project.” Further, 
+as has been the case for the past several years, DOD’s CTR program continues to work with non-
+Russian countries in the former Soviet Union (FSU), and continues to expand cooperative 
+programs outside the former Soviet Union. 
+
+DOD CTR funds are requested through the Office of the Secretary of Defense. The Office of the 
+Assistant Secretary of Defense for Global Strategic Affairs provides long-range planning and 
+guidance. The Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological 
+Defense Programs provides program budget and implementation oversight. The Defense Threat 
+Reduction Agency (DTRA) is the implementing agency and manages CTR programming and 
+contracting. DOD CTR programs are appropriated by the House and Senate Defense 
+Appropriations subcommittees and authorized by the Armed Services committees. 
+
+ Department of Energy (DOE) 
+
+The Department of Energy has contributed to U.S. threat reduction and nonproliferation 
+assistance to the former Soviet states since the early 1990s, when DOD’s CTR budget included a 
+ 
+
+27 Appendix A at the end of this report contains tables that detail recent appropriations and the FY2014 budget request 
+for threat reduction and nonproliferation programs in each of these agencies. 
+28 U.S. Department of Defense, Fiscal Year 2015 Budget Estimates: Cooperative Threat Reduction Program , March 
+2014, p. 1137, http://comptroller.defense.gov/Portals/45/Documents/defbudget/fy2015/budget_justification/pdfs/
+01_Operation_and_Maintenance/O_M_VOL_1_PART_2/CTR_PB15.pdf. 
+29 Ibid. 
+
+ Congressional Research Service 
+
+ 10 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+small amount of funding for materials control and protection. DOE officials and their DOD 
+counterparts participated in early efforts to outline projects and reach agreement with Russian 
+officials on assistance to secure nuclear materials. This effort grew into the International Nuclear 
+Materials Protection and Cooperation Program, which seeks to increase “the security of 
+vulnerable stockpiles of nuclear materials worldwide, preventing the loss of such material, and 
+significantly improving the ability to deter, detect, and interdict their illicit trafficking.”30 
+Between FY1993 and FY2014, Congress appropriated around $6.4 billion for this effort. In 1994, 
+DOE also initiated efforts to help retrain and redirect Soviet-era nuclear scientists and engineers 
+so that they would not sell their knowledge to other nations seeking their own nuclear weapons. 
+In addition, DOE established in 2004 the Global Threat Reduction Initiative (GTRI) to secure, 
+protect, and in some cases, remove vulnerable nuclear and radiological materials at civilian 
+facilities worldwide. These program areas are described in more detail below. 
+
+The Department of Energy, in its budget request for FY2015, is seeking a total of $643 million for 
+these nonproliferation assistance programs. This total represents a significant reduction from the 
+$870 million appropriated in FY2014 and the $1.26 billion provided in the Consolidated Further 
+Appropriations Act, 2013 (P.L. 113-6).31 As is noted below, within this total budget, DOE has 
+reduced funding for several program areas that had been a high priority in previous years. DOE 
+claims that, in some areas, these reductions are a sign of progress because they reflect the 
+completion of many ongoing projects. Some of the reductions, however, are due to the lapse in 
+the MOU governing the CTR program. Although DOE can continue much of its work under the 
+bilateral protocol to the Multilateral Nuclear Environmental Program in the Russian Federation 
+(MNEPR) Agreement, it can no longer work with the Russian Ministry of Defense. This has 
+affected the amount of funding requested for some of its warhead security work. 
+
+DOE funds these activities through the National Nuclear Security Administration’s (NNSA’s) 
+Defense Nuclear Nonproliferation account. DOE nonproliferation programs are authorized by the 
+House and Senate Armed Services committees, and are appropriated by the House and Senate 
+Energy and Water Development Appropriations subcommittees. 
+
+ The State Department 
+
+The State Department has played an integral role in U.S. nonproliferation and threat reduction 
+programs since their inception. It has taken the lead in negotiating the broad agreements needed 
+before recipient nations can receive U.S. assistance and in providing for broad policy 
+coordination among the U.S. agencies and between the United States and recipient nations. The 
+State Department also manages the Nonproliferation and Disarmament Fund (NDF), which 
+“undertakes rapid-response activities to reduce threat that are unforeseen and unanticipated 
+around the globe.” NDF has received between $15 million and $40 million per year since 1993, 
+with most funds used on projects outside the former Soviet Union. It currently is funding ongoing 
+activities the Middle East, such as Syria chemical weapons destruction efforts.32 The State 
+
+ 
+
+30 Department of Energy, National Nuclear Security Administration , FY2014 Budget Request, Washington, D.C, April 
+2013, pp. DN-80, http://energy.gov/sites/prod/files/2013/04/f0/Volume1.pdf. 
+31 The FY2013 appropriation for DOE programs also does adjust for potential sequestration reductions. 
+32 NDF has “notwithstanding authority” to use funds regardless of the restraints of any other law, and was originally 
+authorized for the former Soviet Union states. Since 1994, Congress, through annual appropriations, has given NDF the 
+authority to use funds anywhere in the world and carry forward unspent balances as needed. For a list of past projects, 
+see http://www.state.gov/t/isn/58382.htm. 
+
+ Congressional Research Service 
+
+ 11 
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+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+Department also contributes to U.S. nonproliferation goals through its Export Control and Related 
+Border Security Assistance (EXBS) program, which addresses concerns about the illicit 
+trafficking of CBRN materials and dual use goods and technologies. The State Department also 
+funds the Global Threat Reduction (GTR) program, which manages programs designed to engage 
+scientists to prevent proliferation of WMD materials or expertise, with priority placed on projects 
+in Yemen, Pakistan, and Iraq. The WMD Terrorism program assists others nations’ capacity to 
+respond to a WMD terrorist event and to detect, deter, and respond to nuclear smuggling. These 
+programs are described in more detail below. 
+
+The State Department is seeking $25 million for the NDF, $56.7 million for its EXBS program, 
+$65.1 million for its GTR program and $4.8 for the WMD terrorism program for FY2015. This 
+request reflects an increase of approximately $4 million from the FY2014 request for these 
+programs, but a decrease of $24.8 million from the FY2014 program spending estimate. The State 
+Department nonproliferation programs are housed in the International Security and 
+Nonproliferation Bureau (ISN), and are funded out of the Nonproliferation, Anti-terrorism, 
+Demining and Related Activities (NADR) account in the State Department budget. 
+
+ Department of Homeland Security (DHS) 
+
+The Department of Homeland Security also implements programs that seek to stem the illicit 
+transfer of CBRN materials. The International Cargo Screening program33 screens cargo overseas 
+to prevent a nuclear or radiological device from being brought into the United States. DHS 
+personnel work with foreign customs officials to target and examine high-risk cargo before the 
+cargo containers are placed on vessels bound for the United States. DHS also works with the 
+DOE Megaports Initiative to install technology at foreign ports that rapidly scans shipping 
+containers for radiological or nuclear materials. Overall, these programs are shifting from relying 
+heavily on placing DHS inspectors overseas to installing and maintaining detection equipment. 
+DHS has requested $69.2 million for the International Cargo Screening program in FY2015, 
+funded out of the Customs and Border Protection portion of the DHS budget. These programs are 
+described in more detail below. 
+
+ Issues for Congress 
+
+Over the years, Congress has addressed a number of issues that came up during implementation 
+of U.S. threat reduction and nonproliferation programs in Russia and the former Soviet Union. 
+Many of these issues may continue to resonate as the programs grow into global security 
+partnerships. 
+
+ Coordination Across Government Agencies 
+
+The United States implements programs that seek to secure CBRN weapons, materials, and 
+knowledge through several different government agencies. In some cases, different agencies fund 
+programs that seek to achieve the same goals. For example, the State Department and Energy 
+Department both fund programs that seek to secure borders, redirect scientists, and establish “best 
+ 
+
+33 This program includes both the Container Security Initiative (CSI) and the Secure Freight Initiative (SFI). Prior to 
+FY2009, this program area was called “Container Security Initiative.” 
+
+ Congressional Research Service 
+
+ 12 
+
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+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+practices in partner countries.” DOD and DHS also fund programs that seek to prevent the illicit 
+transfer of CBRN materials across international borders. At the same time, personnel from 
+different agencies may work together to implement a specific project. 
+
+This overlap, and the potential for redundant efforts, has led many analysts to suggest that the 
+United States identify a single coordinating authority, which could be either an individual or a 
+committee, to make sure the agencies establish agreed priorities and share resources and 
+expertise. A high-level program coordinator might also help resolve competing demands for 
+budgetary resources, eliminate overlap and redundancy, and coordinate implementation across 
+agencies. In the Implementing the Recommendations of the 9/11 Commission Act of 2007 (P.L. 
+110-53), Congress called for the creation of an Office of the United States Coordinator for the 
+Prevention of Weapons of Mass Destruction Proliferation and Terrorism within the Executive 
+Office of the President (§1841). Others, however, have rejected the call for a single program 
+coordinator, noting that the job can be achieved through the regular NSC structure.34 They note 
+that a new coordinator might complicate the existing interagency coordinating process.35 
+
+President Obama’s May 2010 National Security Strategy stated that “work remains to foster 
+coordination across departments and agencies. Key steps include more effectively ensuring 
+alignment of resources with our national security strategy, adapting the education and training of 
+national security professionals to equip them to meet modern challenges, reviewing authorities 
+and mechanisms to implement and coordinate assistance programs, and other policies and 
+programs that strengthen coordination.” This challenge was also highlighted in the 9/11 
+Commission’s report, the report of the Commission on the Prevention of WMD Proliferation and 
+Terrorism, as well as oversight hearings.36 
+
+In response to concerns about program coordination, the Obama Administration designated a new 
+director on the NSC staff who would serve as the coordinator for the prevention of WMD 
+proliferation and terrorism. This NSC director had a deputy director who focused specifically on 
+threat reduction efforts, and sought to coordinate the threat reduction and nonproliferation 
+programs across agencies. This director did not, however, have direct control over the budgets of 
+the participating agencies. Nevertheless, officials in the Obama Administration have indicated 
+that the Administration has succeeded in coordinating program implementation across agencies. 
+In testimony before the Senate Armed Services Committee in April 2013, Administration officials 
+emphasized that effective coordination allows the United States to pool expertise and maximize 
+the effectiveness of U.S. programs when resources are limited.37 
+
+ 
+
+34 For example, the George W. Bush Administration said that it coordinated these programs through a committee 
+chaired by a National Security Council senior director, with assistant secretary-level representatives from State, 
+Defense, Energy and other concerned agencies. U.S. Senate. Committee on Governmental Affairs, Subcommittee on 
+International Security, Proliferation and Federal Services. Hearing. Combating Proliferation of Weapons of Mass 
+Destruction (WMD) with Non-proliferation Programs: Non-proliferation Assistance Coordination Act of 2001. 
+Statement of Vann Van Diepen, Deputy Assistant Secretary of State for Nonproliferation. November 29, 2001. 
+35 Ibid. Statement of Marshall Billingslea, Deputy Assistant Secretary of Defense for Negotiations. 
+36 For example, Senate Homeland Security and Governmental Affairs Committee Hearing, “Nuclear Terrorism: 
+Strengthening Our Domestic Defenses, Part I”, June 30, 2010, and Part II on September 15, 2010. 
+37 See, for example, the testimony of Madelyn R. Creedon, Assistant Secretary of Defense, Global Strategic Affairs, 
+U.S. Congress, Senate Armed Services, Emerging Threats and Capabilities, Proliferation Prevention Programs, 
+Hearing, 113th Cong., 1st sess., April 23, 2013. 
+
+ Congressional Research Service 
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+
+ 
+
+Several agencies have their own coordinators for related activities. The Department of Homeland 
+Security has a role in coordinating executive branch programs to combat nuclear terrorism. The 
+DHS Domestic Nuclear Detection Office was tasked with formulating a “Global Nuclear 
+Detection Architecture” by the Safe Port Act (P.L. 109-347) to protect the United States against 
+nuclear or radiological attack.38 The “global” architecture is to be guided by DNDO. However, 
+DNDO was given authority to implement this architecture in the United States, while the 
+Departments of Defense, State, and Energy were to continue their activities related to nuclear 
+detection internationally. This has resulted in DNDO performing a coordinating function where 
+the other agencies submit lists of activities that DNDO then places in its overall framework to 
+assess where gaps or duplication might occur. A Joint Interagency Review is performed annually. 
+
+In addition, the State Department named a coordinator for threat reduction activities at the 
+beginning of the Obama Administration, Ambassador Bonnie Jenkins. Ambassador Jenkins is the 
+State Department’s lead for the Nuclear Security Summit, coordinates the State Department’s 
+activities toward the four-year nuclear security effort, and coordinates “a number of interagency 
+CTR programs to help ensure a coordinated U.S. approach when promoting these programs 
+internationally.”39 
+
+Policy coordination committees are a tool that can be used to formalize communication across 
+agencies. The WMD Commission in its December 2009 report identified “nearly 200 interagency 
+committees and working groups that address WMD, counterproliferation and counterterrorism 
+issues.”40 Some have suggested that an alternative to policy coordinating committees, especially 
+in the implementation-heavy work of nuclear terrorism prevention and nuclear security (i.e., 
+border guard training, material removal from research reactors, etc.), may be informal 
+coordination between working level employees. Officials have told CRS that this kind of 
+coordination happens on a daily basis without need for formal mandates, for example on specific 
+threat reduction initiatives in a foreign country. Analysts and officials have pointed to the long-
+term professional relationships amongst current senior officials across agencies that may lead to 
+more effective and regular (but not necessarily formal) coordination of tasks and responsibilities. 
+This raises the question of the sustainability of such coordination. 
+
+ Priority Within the Executive Branch 
+
+Over the years, many analysts have argued that the United States can best succeed in securing 
+CBRN weapons, materials, and knowledge when the programs that support this goal receive a 
+high level of attention from senior government officials. This attention might signal that the 
+programs should be of high priority for the agencies, and this priority could then be reflected in 
+agency budgets. President Bush followed this pattern during his Administration, when he and 
+President Putin agreed at Bratislava to accelerate warhead and materials security programs. The 
+President’s budget requested additional funds for these programs, and the two countries 
+completed a number of projects on a shorter time frame. 
+
+In the Obama Administration, the President has also often emphasized the importance of these 
+programs and their goals. He highlighted his Administration’s concerns with the threat of nuclear 
+
+ 
+
+38 See CRS Report RL34574, The Global Nuclear Detection Architecture: Issues for Congress , by Dana A. Shea. 
+39 http://www.state.gov/r/pa/ei/biog/126045.htm. 
+40 CRS has not independently confirmed this number. 
+
+ Congressional Research Service 
+
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+
+ 
+
+terrorism repeatedly in his first term—in his April 2009 speech in Prague, when he chaired a 
+special U.N. session on nuclear security, and when he established the Nuclear Security Summit 
+process and convened the first summit in Washington in 2010. He reiterated his support for U.S. 
+threat reduction and nonproliferation programs in a speech in December 2012, when celebrating 
+the 20th anniversary of the Nunn-Lugar Cooperative Threat Reduction Program. He not only 
+stated, at that time, that his Administration had “continued to make critical investments in our 
+threat reduction programs” over the previous four years, but also that he intended to “keep 
+investing in these programs because our national security depends on it.”41 
+
+Some analysts outside government, however, have questioned President Obama’s commitment to 
+the future of these programs. They note, specifically, that the President’s budget requests for 
+FY2013, FY2014, and FY2015 reduce funding for programs, such as the Global Threat 
+Reduction Initiative, that are designed to secure and eliminate nuclear materials. They also note 
+that the Administration has scaled back its goals for the Second Line of Defense Program, which 
+is designed to help secure borders and prevent smuggling of nuclear materials. Some analysts 
+outside government argue that these reductions will undercut the programs and reflect a change in 
+Administration priorities. 
+
+There are a number of reasons why funding and the pace of effort in these programs may have 
+declined. For example, these programs require cooperation from partner countries, and that 
+cooperation often comes through detailed, written agreements. Delays in reaching these 
+agreements can slow the start of a program, which can reduce the required level of funding in 
+subsequent years. Moreover, as some in the Administration have noted, a decline in funding can 
+be an indicator of a program’s success. This is the case for many of the early CTR programs, such 
+as strategic offensive arms elimination, through which Russia and Ukraine have nearly completed 
+the elimination of strategic weapons limited by arms control agreements. 
+
+Overall, decline in some major programs such as DOE’s IMPC&A and some DOD work, such as 
+CW destruction, generally reflects a wrapping up of major construction projects in the Russian 
+Federation. New areas of work related to facility security and border control training may be less 
+expensive than past projects. In some areas, DOD and State Departments budgets have remained 
+steady, as is seen in Appendix A . Arguably, the DOE budget has been reduced in areas where 
+existing program goals have been accomplished. However, some critics of reductions point out 
+that funding should remain at least at the same level so that these programs can identify and work 
+against new threats and in new geographical areas. Others advocate for an expansion of funds for 
+specific regions of the world, such as the Middle East. 
+
+ Measuring Success and Metrics 
+
+During its oversight of U.S. threat reduction and nonproliferation programs, Congress has often 
+questioned whether U.S. assistance is achieving the desired goals. Members have questioned 
+whether specific programs, or areas of focus for several programs, have produced sufficient 
+results to justify the continued allocation of U.S. funds to the effort. In the National Defense 
+Authorization Act for FY2010 (P.L. 111-84) Congress directed the Secretary of Defense to 
+develop and implement metrics to measure the impact and effectiveness of DOD’s CTR activities. 
+ 
+
+41 The White House, Office of the Press Secretary, Remarks by the President at the Nunn-Lugar Cooperative Threat 
+Reduction Symposium , Washington, D.C., December 3, 2012, http://www.whitehouse.gov/the-press-office/2012/12/03/
+remarks-president-nunn-lugar-cooperative-threat-reduction-symposium. 
+
+ Congressional Research Service 
+
+ 15 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+For many of the DOD’s CTR programs, measuring success has been a relatively straightforward 
+exercise. Senator Lugar often referred to the Defense Threat Reduction Agency’s CTR Scorecard 
+to describe the numbers of nuclear weapons and delivery systems that were no longer actively 
+deployed in Russia’s nuclear arsenal.42 DOD and DOE have also reported the numbers of nuclear 
+weapons transported to secure storage locations and the numbers of storage locations for nuclear 
+warheads and nuclear materials that received upgrades to their security systems. Other examples 
+of successes that are measurable are the removal of weapons-usable material and nuclear 
+enrichment technology from Libya, the destruction of chemical munitions and chemical weapons 
+agents in Libya, and the dismantlement of biological weapons infrastructure in Iraq. 
+
+As the United States has expanded its threat reduction assistance to nations outside the former 
+Soviet states, and as the programs have emphasized cooperative engagement, capacity-building, 
+and best practices instead of weapons dismantlement and facility security, the problem of 
+measuring progress has grown more complicated. As the National Academy of Sciences noted in 
+its 2012 report, “It is complex and challenging to develop metrics for the partner’s capabilities 
+and the personal and institutional relationships established.... ”43 While participants in the 
+program may be confident in their ability to share knowledge and build cooperative relationships, 
+they may be less confident in their ability to measure the relationship between funding and 
+progress in cooperation. 
+
+However, most of the threat reduction assistance currently underway is more difficult to quantify. 
+In many cases, progress is evident in access to decision makers and operators, and success is 
+reflected in the growth of relationships. In some cases, however, it may be possible to devise 
+metrics to measure progress. For example, the State Department’s EXBS program uses a Rating 
+Assessment Tool with a 419-point survey to score a country’s licensing, enforcement, industry 
+outreach, and nonproliferation regime adherence. According to the State Department, this tool 
+allows the program “to determine weaknesses in each partner country’s strategic trade control 
+system, ascertain effectiveness of prior bilateral EXBS assistance activities, and pinpoint areas 
+where limited assistance dollars can achieve the greatest impact.” This tool is also used to 
+measure how the EXBS assistance has improved the country’s strategic trade controls over time. 
+
+The National Defense Authorization Act for FY2010 (P.L. 111-84) also mandated that DOD 
+contract with the National Academy of Sciences to review the report developed by DOD. The 
+National Academy completed this review, and published its report, Improving Metrics for the 
+Department of Defense Cooperative Threat Reduction Programs , in 2012.44 This report 
+specifically addressed the challenges of measuring the success of programs focused on capacity-
+building or scientist engagement. It noted that it is not only difficult to measure progress in these 
+programs, but also difficult to identify how these programs reduce threats to U.S. national 
+security. As a result, the NAS report indicates that before measuring whether or not the programs 
+are successful, the U.S. agencies responsible for the programs should identify clear, measurable 
+objectives and outline how those objectives relate to U.S. national security goals. The report also 
+notes that the effort to measure progress in some programs may be further complicated by the fact 
+
+ 
+
+42 Defense Threat Reduction Agency, Nunn–Lugar CTR Scorecard, February 2013. http://www.dtra.mil/docs/default-
+document-library/20130101_fy13_ctr-scorecard_slides_jan13.pdf?sfvrsn=0. 
+43 National Academy of Sciences, Improving Metrics for the Department of Defense Cooperative Threat Reduction 
+Programs , Washington, D.C., 2012. p. 3. http://www.nap.edu/catalog.php?record_id=13289. 
+44 National Academy of Sciences, Improving Metrics for the Department of Defense Cooperative Threat Reduction 
+Programs , Washington, D.C., 2012, http://www.nap.edu/catalog.php?record_id=13289. 
+
+ Congressional Research Service 
+
+ 16 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+that both the objectives and the steps taken to reach these objectives can change over time.45 In 
+addition, regardless of how precise the metrics or how well the measures of success are related to 
+addressing threats to U.S. national security, the process of measuring success may find it difficult 
+to capture the value of newly developed personal relationships and a more cooperative 
+atmosphere. Moreover, the programs are choosing partner countries and projects on the basis of 
+their proliferation risk (the assessment of which varies somewhat by agency) before starting a 
+project. Identifying threats and prioritization of work based on risk appears to be becoming 
+increasingly important in program management. 
+
+As the United States continues to shift its focus from “threat reduction” to “global security 
+engagement,” with the programs doing more to build capacity than eliminate weapons, Congress 
+may continue to question how to measure progress and identify success. This is evident in the 
+Senate version of the FY2015 National Defense Authorization Act (S. 2410, Sec. 1344), where 
+the Senate calls on the Secretary of Defense to implement metrics “to measure the impact and 
+effectiveness” of DOD’s CTR activities. 
+
+ Access and Transparency 
+
+Over the years, as the United States provided assistance to Russia, it insisted on a level of 
+transparency and openness that would allow it to confirm that the equipment and assistance paid 
+for with U.S. funds were used for their intended purposes and that the equipment was installed 
+and operated correctly. Russia, however, in some cases, sought to limit access and transparency to 
+protect sensitive facilities and information from foreign inspection. For example, Russia did not 
+provide complete information about or access to facilities in its biological weapons complex, 
+which limited the implementation of cooperative biological engagement programs. In addition, it 
+did not provide the United States with access to many facilities in Russia’s nuclear weapons 
+complex, leaving large holes in the U.S. understanding of the potential security challenges 
+regarding security for the nuclear materials at those facilities. 
+
+Press reports indicate that Russia cited its concerns about U.S. demands for access and 
+transparency in the 2012 and 2013 discussions on the future of the CTR umbrella agreement. 
+According to some reports, Russian officials argued that the provisions that provide the United 
+States with extensive access to Russian facilities and Russian strategic forces, without offering 
+Russia similar access to U.S. nuclear facilities and forces, are inequitable and unfair.46 Russian 
+officials have indicated that a future agreement, if it exists, should provide for a more balanced 
+approach. 
+
+Some U.S. analysts have indicated that they do not think Russia was being unreasonable in 
+seeking changes, and more balance, in the CTR umbrella agreement. They note that times had 
+changed in the 20 years since the programs began. Russia’s financial position had improved and 
+Russia expected to be treated as more of a partner, rather than an aid recipient, when pursuing 
+cooperative security programs.47 There were limits, however, to how much the United States 
+ 
+
+45 National Academy of Sciences, Improving Metrics for the Department of Defense Cooperative Threat Reduction 
+Programs , Washington, D.C., 2012. p. 5. http://www.nap.edu/catalog.php?record_id=13289. 
+46 “Russia Scours Budget for Funds to Replace U.S. Disarmament Assistance,” Global Security Newswire , October 19, 
+2012. 
+47 See, for example, William Tobey, “Boost Phase,” Foreign Policy , October 19, 2012. See, also, Douglas Birch, 
+“Letting Go of “Loose Nukes,” Foreign Policy , October 31, 2012. 
+
+ Congressional Research Service 
+
+ 17 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+could alter the access and transparency provisions in the umbrella agreement. DOD contracting 
+rules, for example, obligate the recipient to allow DOD access to confirm that the equipment is 
+used correctly and operating properly. Moreover, although Russia’s interest in protecting secret 
+details about its nuclear weapons programs may be understandable, this secrecy, and the resulting 
+delays in program implementation, served to undermine support in the United States for threat 
+reduction work in Russia. 
+
+As the United States expands it threat reduction and nonproliferation programs to a growing 
+number of countries around the world, it may face additional questions about the level of access 
+and transparency required for these programs. The dynamics of this problem are different in 
+countries that do not possess WMD. Therefore, working with states that possess nuclear weapons 
+such as India, Pakistan, and China, the access and transparency challenges will be greater than 
+with other partners. The majority of partner countries at present do not have WMD, and the 
+“cooperative engagement” model seems to presume that partner countries will willingly open 
+their facilities to U.S. experts so that they can work to improve security and share “best practices” 
+when handling dangerous materials. But these programs may still encounter legal or procedural 
+barriers to implementation, particularly if officials in other countries view U.S. interest in their 
+programs as a sign of U.S. concern about threats emanating from those countries. For example, if 
+a particular country is sensitive about working with a security-related United States government 
+agency, then other federal agencies, such as HHS or DOE, may take the lead for that project. 
+
+ International Cooperation—The G-8 Global Partnership 
+
+There is near-universal agreement, both within the U.S. government and among analysts outside 
+the U.S. government, that the potential proliferation of weapons of mass destruction to rogue 
+nations or terrorist groups presents a global problem that requires an international response. 
+Following the terrorist attacks of September 11, 2001, the United States decided to appeal to other 
+countries to increase the resources dedicated to preventing a terrorist attack using WMD. This 
+effort first expanded the number of donor countries contributing to threat reduction work in 
+Russia and the former Soviet Union (FSU), and later expanded the number of recipient countries 
+beyond the FSU borders. 
+
+Under Canada’s initiative, during the G-8 summit in Kananaskis in July 2002, the United States, 
+Russia, and other G-8 leaders agreed to establish a long-term program—the G-8 Global 
+Partnership (GP) Against Weapons of Mass Destruction—to stop the spread of weapons of mass 
+destruction and related materials and technology. Under this program, known as 10+10 over 10, 
+the United States pledged to provide $10 billion over 10 years to sustain ongoing threat reduction 
+programs in Russia; this amount of $1 billion per year was essentially equal to existing U.S. 
+spending on threat reduction and nonproliferation programs in Russia. The other G-8 nations also 
+agreed that they would provide, together, up to $10 billion over 10 years. This included a Russian 
+pledge to contribute $2 billion of its own money. According to the State Department, Global 
+Partnership funding has totaled $21 billion since 2002. The United States has promised an 
+additional $10 billion in Global Partnership funds in the 2012-2022 timeframe, subject to 
+congressional appropriations. 
+
+Russia and other Global Partnership funding recipients must adopt a set of guidelines that provide 
+for “effective monitoring, auditing, and transparency measures” and “adequate access for donor 
+representatives at work sites.” The guidelines stipulate that the assistance would be free from 
+taxes and other charges and that it would ensure adequate liability protections for donor countries 
+
+ Congressional Research Service 
+
+ 18 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+and their personnel.48 These provisions mirrored those in the U.S.-Russia CTR umbrella 
+agreement, and the guarantees were considered key to convincing new donor states to participate. 
+
+In 2002, the G-8 leaders agreed that this program would initially focus on threat reduction and 
+nonproliferation programs in Russia; they have since extended it to countries around the world. 
+The first Latin American partner, Mexico, joined in 2012. As of April 2014, there were 27 
+members of the Global Partnership: Canada, France, Germany, Italy, Japan, Russian Federation, 
+United Kingdom, United States, Australia, Belgium, Czech Republic, Denmark, European Union, 
+Finland, Ireland, Kazakhstan, Mexico, the Netherlands, New Zealand, Norway, Poland, Republic 
+of Korea, Sweden, Switzerland, Ukraine, Hungary, and the Philippines. The GP also coordinates 
+activities with relevant international organizations. 
+
+Analysts initially questioned how the group would set priorities and divide up responsibilities 
+over different types of nonproliferation projects. In the statement released after the Kananaskis 
+summit, they listed several projects, including the destruction of chemical weapons, 
+dismantlement of decommissioned nuclear submarines, disposition of fissile materials, and 
+employment of former weapons scientists as high-priority projects.49 The Global Partnership does 
+not rely on a single coordinating body to either identify new projects or set priorities among 
+competing projects. Each nation allocates its own funds to those programs that it views as high-
+priority endeavors. Partners then share experiences and project information in a working group 
+and through the annual publication of the GP Annex, which lists all projects by donor country.50 
+This document shows continuing interest in nuclear security and the disposition of fissile 
+materials, chemical weapons destruction, and the decommissioning of Russia’s nuclear 
+submarines. The United States has advocated for expanded funding in the area of biosecurity in 
+recent years, and made this subject the focus of its 2012 G8 GP chairmanship. 
+
+The United States held the G-8 presidency in 2012, and the Obama Administration continued its 
+policy of actively promoting expansion of the Partnership to new geographical regions.51 Mexico 
+joined in December 2012, the first Latin American state to participate. The United States has also 
+promoted greater attention to bio-security in the context of the Global Partnership. Under its 2012 
+chairmanship, it created a sub-working group on biological security to encourage and coordinate 
+projects in this area. 
+
+The United Kingdom’s 2013 presidency focused on increasing projects, expanding GP 
+membership, strengthening information security, and implementing UN Security Council 
+Resolution 1540. Russia was to hold the G8 presidency in 2014, but the planned meeting in Sochi 
+was cancelled after the remaining seven nations suspended Russia’s participation in response to 
+its annexation of Crimea and aggression against Ukraine. The remaining members met as the G-7 
+in Belgium on June 4-5, 2014.52 In their Declaration on Non-Proliferation and Disarmament for 
+ 
+
+48 “The G8 Global Partnership Against the Spread of Weapons and Materials of Mass Destruction.” Statement by the 
+Group of Eight Leaders. Kananaskis, Canada. June 27, 2002. 
+49 “The G8 Global Partnership Against the Spread of Weapons and Materials of Mass Destruction.” Statement by the 
+Group of Eight Leaders. Kananaskis, Canada. June 27, 2002. 
+50 For more information on the project areas funded by participating nations, see U.S. Department of State, 
+ Consolidated Report Data, 2012 , Global Parntership Working Group Annual Report, , Washington, D.C., 
+http://www.state.gov/documents/organization/208032.pdf. 
+51 “Global Partnership 2012,” State Department website, http://www.state.gov/t/isn/c12743.htm. 
+52 “G-7 Leaders Statement,” The White House, March 2, 2014, http://www.whitehouse.gov/the-press-office/2014/03/
+02/g-7-leaders-statement. 
+
+ Congressional Research Service 
+
+ 19 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ 2014 , the G-7 participants reaffirmed their commitment to the Global Partnership and highlighted 
+the program’s expansion to include additional nations around the world. The statement did not, 
+however, make any references to continuing or future efforts to support programs in Russia, 
+possibly due to the fact that most Global Partnership activities in Russia are already winding 
+down.53 
+
+ The Programs 
+
+ Securing and Eliminating Nuclear Weapons 
+
+ Strategic Offensive Arms Elimination 
+
+When the Soviet Union collapsed in 1991, it had more than 11,000 warheads deployed on nearly 
+1,400 land-based intercontinental ballistic missiles (ICBMs), 940 submarine launched ballistic 
+missiles (SLBMs), and 162 heavy bombers. These weapons were deployed in four of the former 
+Soviet republics—Ukraine, Belarus, Kazakhstan, and Russia. In 1994, Russia agreed to reduce its 
+nuclear forces to the limits outlined in the original Strategic Arms Reduction Treaty (START), 
+while the other three all agreed to eliminate all the nuclear weapons on their territories. Promises 
+of U.S. financial and technical assistance through DOD’s CTR program helped win this 
+agreement.54 The United States has provided these nations with technology and expertise needed 
+to deactivate and dismantle missiles, launchers, submarines, and bombers. More than half of the 
+CTR funding in the program’s early years served this purpose, although that proportion declined 
+in recent years as the work was completed in Belarus and Kazakhstan and as the level of effort 
+declined in Russia and Ukraine. 
+
+According to the Defense Threat Reduction Agency, the CTR program had, as of January 31, 
+2013, helped deactivate 7,613 warheads, 910 ICBMs, and nearly 692 ICBM launchers; 695 
+SLBMs and 492 SLBM launch tubes; and 155 heavy bombers.55 Much of the work is now 
+completed, however, as the Memorandum of Understanding governing these projects has expired. 
+According to DOD, the United States is no longer supporting strategic launcher and missile 
+elimination in Russia. 
+
+In Russia, the United States has helped eliminate and dismantle SS-18 and SS-19 ICBMs, 
+disassemble and eliminate components of the SS-N-20 SLBM, eliminate SS-25 ICBMs and their 
+road-mobile launchers, and destroy rail-mobile SS-24 ICBMs and their launchers. Funding in this 
+project area has also supported efforts to assist Russia in eliminating SS-19 and SS-25 ICBMs 
+and their launchers, and in completing the dismantlement of Russian Delta-III and Typhoon 
+submarines. These are partnership programs, with the United States responsible for some of the 
+dismantlement activities, and Russia responsible for others.56 
+
+ 
+
+53 G-7 Brussels, 2014, “Declaration on Non-Proliferation and Disarmament for 2014,” http://www.consilium.europa.eu/
+uedocs/cms_data/docs/pressdata/en/ec/143120.pdf. 
+54 U.S. Department of Defense. Cooperative Threat Reduction . April 1995. Washington, DC. p. 1. 
+55 For the full CTR scorecard, see Defense Threat Reduction Agency, http://www.dtra.mil/docs/default-document-
+library/20130101_fy13_ctr-scorecard_slides_jan13.pdf?sfvrsn=0. 
+56 Department of Defense, Cooperative Threat Reduction Program , Annual Report to Congress Fiscal Year 2013, 
+Washington, D.C, March 2013, pp. 13-14. 
+
+ Congressional Research Service 
+
+ 20 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+In Ukraine, the United States and Ukraine have been working on a method to eliminate rocket 
+motors from SS-24 ICBMs. DOD did not request any more funding for this project area in 
+FY2006 and, at that time, planned to complete ongoing work with prior year funds, because the 
+two nations could not agree on a method to eliminate these rocket motors. However, a low level 
+of funding has resumed in recent years, with $1 million requested for FY2015, as the United 
+States now funds the safe storage of 160 rocket motors from SS-24 missiles and plans to buy the 
+casings from Ukraine after Ukraine has removed the propellant. Ukraine has been financing, on 
+its own, the construction and operation of a water washout facility for this purpose. The United 
+States has purchased the empty motor cases, and has helped Ukraine begin construction of an 
+elimination facility for them. According to recent reports, the facility opened in late May 2013.57 
+According to DOD, the United States will help Ukraine maintain this facility, but will cease its 
+support after the last of the motors has been washed-out and eliminated. 
+
+Over the past decade, Congress routinely appropriated $50 million-$70 million per year for 
+strategic offensive arms elimination. In recent years, the Obama Administration requested, and 
+Congress appropriated, $60 million-$70 million per year. The Obama Administration requested 
+$23.3 million for this project area in FY2013. This amount included funding for both strategic 
+offensive arms elimination activities in Russia and those in Ukraine. The Administration 
+requested $10 million for this project area in FY2014, noting that the amount of funding needed 
+in this program area had declined sharply because most elimination activities necessitated by the 
+New START Treaty were complete. 
+
+Because these programs were governed by the MOU that expired in June 2013, they ceased 
+operations in June 2013. As a result, in its version of the FY2014 Defense Authorization Bill (S. 
+1197, §1302), the Senate Armed Services Committee reduced funding for this program area to 
+$5.7 million. The committee noted in its report that it would transfer $75 million from programs 
+that will end in Russia “to CTR nonproliferation efforts in the Middle East, particularly related to 
+Syrian chemical weapons.”58 
+
+ Table 1 summarizes the amount of funding appropriated by Congress for strategic offensive arms 
+elimination projects. 
+
+ Table 1. CTR Funding for Strategic Offensive Arms Elimination (SOAE) 
+
+($ millions) 
+
+ Nation 
+
+ Fiscal years 
+
+ Total appropriation 
+
+Russia FY1993-FY2014 $1,774.4 
+
+Ukraine FY1993-FY2014 
+
+$593 
+
+Kazahkstan FY1994-FY1996 
+
+$64.6 
+
+Belarus FY1994-FY1996 
+
+$3.3 
+
+ Source: CRS Estimates. 
+
+ 
+
+57 “Ukraine, U.S. Jointly Pursue Missile Destruction,” Worldwise News Ukraine , May 21, 2013. 
+58 U.S. Senate Committee on Armed Services, Senate Committee on Armed Services Completes Markup of the National 
+Defense Authorization Act for Fiscal Year 2014 , Press Release, Washington, D.C., June 14, 2013, p. 21, 
+http://www.armed-services.senate.gov/press/. 
+
+ Congressional Research Service 
+
+ 21 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Global Nuclear Security 
+
+DOD altered the structure of its CTR program areas in the FY2012 budget, creating a new 
+program area, Global Nuclear Security. This combined the program areas that had funded the 
+secure transport of nuclear warheads and other qualifying nuclear material to secure storage 
+facilities and dismantlement facilities, security enhancements for storage areas for nuclear 
+warheads, weapons-usable nuclear material, and efforts to establish Centers of Excellence with 
+partner countries to enhance training for nuclear security, material control, and inventory 
+management. According to DOD, this program supports not only efforts to secure nuclear 
+weapons and materials in the former Soviet states, but also “new initiatives to secure nuclear 
+materials across the globe.” 
+
+When funded separately in FY2011, Congress appropriated $164.5 million for the programs 
+captured by GNS. In FY2012, this funding declined to $151 million. The Obama Administration 
+requested $72.3 million for FY2013 and $86.5 million for FY2014. The budget documents did 
+not provide details on how the money would be divided among the constituent programs. 
+However, it is likely that the focus of these programs is shifting to nations outside the former 
+Soviet Union, given the Administration’s added emphasis on global cooperation and the 
+completion of many projects in Russia. In addition, many of the projects funded concluded in 
+mid-2013, as a result of the expiration of the MOU with Russia. As a result, Congress 
+appropriated only $$19.4 million for this program area in FY2014. 
+
+DOD has requested $20.7 million for this program area in the CTR budget for FY2015. Within 
+this total, $3 million is allocated to projects in Russia. One is designed to transport highly 
+enriched spent nuclear reactor fuel to safe storage or to a facility that will bled it down into a 
+lower-enriched product. The other is a project that will provide Russia with assistance in 
+dismantling the launch tubes and reactor on a ballistic missile submarine. Most of the remaining 
+funds in this program area will support the nuclear security centers of excellence; provide 
+equipment and training for partner countries to secure vulnerable nuclear material; and provide 
+equipment and training to enhance nuclear security capabilities of partner countries to perform 
+key security functions such as secure transportation, inventory management, and emergency 
+response. 
+
+ Transportation Security 
+
+When the Soviet Union collapsed in late 1991, thousands of nuclear weapons were spread among 
+four states (Russia, Ukraine, Belarus, and Kazakhstan), and, within each state, the weapons were 
+dispersed among hundreds of deployment and storage areas. The governments in these states 
+agreed to remove the nuclear warheads from non-Russian republics and to store them in a smaller 
+number of facilities in Russia. The United States has helped Russia improve the safety and 
+security of nuclear weapons in transit after they have been removed from deployment. 
+
+In its early years, the program provided armored blankets to protect warheads in transit from 
+potential attacks, storage containers to hold the warheads during transit, and assistance to enhance 
+the safety and security of rail cars used to transport warheads from deployment to storage or 
+dismantlement facilities. Transportation security projects also provided Russia with emergency 
+response vehicles, training, and support equipment that it might need to respond to a nuclear 
+weapons transportation accident. The funding for these programs, through 2012 when they were 
+aggregated in the GNS program area, appears on Table 2 . 
+
+ Congressional Research Service 
+
+ 22 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+According to DOD’s budget request for FY2014, the United States has, in recent years, supported 
+the transportation of “approximately 48 trainloads of deactivated nuclear warheads (1,000 to 
+1,500 warheads) from deployed locations to enhanced security storage sites or dismantlement and 
+from storage to dismantlement facilities.” According to DOD, remaining transportation security 
+projects transitioned to the Russian Ministry of Defense in June 2013. 
+
+ Table 2. CTR Funding for Transportation Security 
+
+($ millions) 
+
+ Project 
+
+ Fiscal years 
+
+ Total appropriation 
+
+Armored Blankets 
+
+FY1992-FY1993 
+
+$3.1 
+
+Emergency Response 
+
+FY1992-FY1996 
+
+$29.2 
+
+Railcar security enhancements 
+
+FY1992-FY1994 
+
+$21.5 
+
+Weapons Transportation Security 
+
+FY1995-FY2011 
+
+$355.4 
+
+ Source: Controlling Nuclear Warheads and Materials: A Report Card and Action Plan , by Matthew Bunn, et al. Project 
+on Managing the Atom. March 2003; Updated Funding Analysis of FY09 International WMD Security Programs, 
+by Michel e Marchesano. Partnership for Global Security. July 2009. 
+
+ Nuclear Security Enhancements 
+
+Over the years, the CTR program has helped Russia improve security at storage facilities for 
+strategic and tactical nuclear warheads, a program initially referred to as “Weapons Storage 
+Security.” DOD now refers to this program as “Nuclear Security Enhancements.” Russia has 
+three types of storage sites—operational sites, storage sites for weapons removed from 
+deployment, and rail transfer points. The United States does not provide assistance at operational 
+sites. Under the CTR program, DOD has enhanced security at both large “national stockpile 
+storage sites” and smaller storage sites at Navy, Air Force, and Strategic Rocket Force (SRF) 
+bases.59 DOD provided perimeter fencing as a “quick fix” for vulnerable sites, and more 
+comprehensive upgrades, including alarm systems and inventory control and management 
+equipment to keep track of warheads in storage. The Department of Energy has also addressed 
+security needs at rail transfer points that store warheads from the Russian Navy, and storage sites 
+for warheads belonging to the Strategic Rocket Forces. 
+
+For several years, this effort was slowed by Russia’s reluctance to provide the United States with 
+information about the precise number of sites in need of security upgrades and its refusal to allow 
+the United States access to sites to design appropriate upgrades.60 The United States and Russia 
+completed agreements in February 2003 that provided the United States with a degree of access 
+to these sites so that U.S. personnel could begin to plan the installation of physical security 
+upgrades.61 In 2005, Presidents Bush and Putin pledged to accelerate work on weapons storage 
+security. After Russia identified all the sites in need of upgrades, the United States agreed to 
+
+ 
+
+59 The total number of sites remains classified. For details on DOD’s plans, see U.S. General Accounting Office. 
+ Weapons of Mass Destruction: Additional Russian Cooperation Needed to Facilitate U.S. Efforts to Improve Security 
+at Russian Sites . GAO-02-482. March 2003. p. 34. 
+60 Ibid., p. 36. 
+61 U.S. House. Committee on Armed Services. Statement of Dr. J.D. Crouch, Assistant Secretary of Defense for 
+International Security Policy. March 4, 2003. 
+
+ Congressional Research Service 
+
+ 23 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+provide assistance at 15 sites, 8 with funding from the CTR program and 7 with funding from the 
+DOE nonproliferation budget. With the accelerated effort, both DOD and DOE reported that they 
+completed the installation of security upgrades by the end of 2008. DOD then shifted funding 
+towards sustainment activities, rather than further upgrades. 
+
+In a complementary effort, DOD is establishing a Security Assistance Training Center that will 
+train Russian students to use and maintain the physical security upgrades that the CTR program 
+provided at nuclear weapons storage sites. DOD has noted that this project will also serve as a 
+model for the Nuclear Security Centers of Excellence discussed below. DOD is using funds 
+appropriated prior to FY2011 for this Center, and has not requested additional funding since that 
+time. 
+
+Between FY1995 and FY2011, before this program was combined with others in the GNS 
+account, Congress appropriated around $840 million for weapons storage security.62 Funding for 
+this program peaked in FY2006, when the Bush Administration requested $74.1 million for 
+weapons storage security, added $10 million more in a reprogramming from the strategic 
+offensive arms elimination account, and requested an additional $44.5 million in the FY2006 
+Emergency Supplemental Appropriations package. This funding was intended to accelerate the 
+program, in response to agreements that President Bush reached with Russia’s President Putin. As 
+ Table 3 below indicates, funding has declined to $10 million-$20 million per year in recent years, 
+after DOD completed many of the projects that had been accelerated earlier. In its FY2014 budget 
+request for the CTR programs, DOD indicated that it would continue to help Russia “build 
+capacity to sustain security at 18 nuclear weapons storage sites and 5 rail transfer points.” 
+However, this effort transitioned to the Russian Ministry of Defense in June 2013 after the MOU 
+governing the CTR program expired. 
+
+ Warhead Security and the Department of Energy 
+
+Through its International Materials Protection and Cooperation program, the Department of 
+Energy has implemented programs that “secure nuclear weapons and weapons-usable nuclear 
+materials by upgrading security at nuclear sites, by consolidating these materials to sites where 
+installation of enhanced security systems have already been completed.... ”63 This effort is known 
+as the Materials Protection, Control and Accounting Program (MPC&A).64 Through this program, 
+DOE installed security upgrades in two phases. First, it installed rapid upgrades that were 
+designed to delay unauthorized access to the storage facilities. These could include the 
+installation of hardened doors and windows, locks and keys to control access, perimeter fences, 
+and moveable barriers at entry points. The second phase provided comprehensive upgrades that 
+were tailored to meet the security needs at each individual facility. These could include 
+monitoring and detection systems, the relocation of guard forces, the consolidation of materials, 
+central alarm systems, and electronic access control systems. 
+
+ 
+
+62 Controlling Nuclear Warheads and Materials: A Report Card and Action Plan , by Matthew Bunn, et al. Project on 
+Managing the Atom. March 2003. 
+63 U.S. Department of Energy. FY2004 Congressional Budget Request. Detailed Budget Justifications. February 2003. 
+p. 623. 
+64 The MPC&A program also includes efforts to improve “nuclear smuggling detection capabilities at international 
+borders.” To do this, DOE funds the Second Line of Defense Program, which is described below. 
+
+ Congressional Research Service 
+
+ 24 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+The U.S. National Nuclear Security Administration (NNSA) identified 105 nuclear sites, with 243 
+buildings, that needed assistance in improving their security systems. These include nuclear 
+warhead and nuclear material storage sites run by the Russian Navy and nuclear warhead storage 
+sites run by Russia’s Strategic Rocket Forces (SRF) and 12th Main Directorate, the branch of 
+Russia’s Ministry of Defense responsible for warhead security and maintenance. The MPC&A 
+program has also supported security enhancements at sites in Russia’s nuclear weapons complex 
+operated by Rosatom and civilian sites that store nuclear material in Russia; these two efforts are 
+addressed below. 
+
+DOE provided assistance to Russia’s Navy by improving security at 39 naval nuclear warhead 
+storage sites and 11 nuclear fuel storage sites. These sites house approximately 60 metric tons of 
+weapons-useable nuclear materials and 4,000 nuclear warheads. According to DOE, it had 
+completed rapid and comprehensive upgrades at all naval nuclear fuel storage sites by the end of 
+2004, and had completed the comprehensive upgrades at warhead sites by 2009. DOE continued 
+to work at these sites through June 2013, providing assistance with sustainability support. This 
+included training and site level maintenance on the equipment at the sites, so that the security will 
+remain in place in the future. 
+
+DOE also worked with Russia to install security upgrades at 25 sites on 11 SRF bases; work on 
+these sites was completed in late October 2007, nearly two years ahead of schedule.65 Through 
+these projects, DOE also upgraded security at nine sites under the command of the 12th Main 
+Directorate. DOE completed the work on upgrades at these sites in FY2009. According to DOE, 
+the process for working at these sites was based on the process agreed with Russia’s Navy, with 
+the installation of rapid upgrades to address immediate security concerns followed by the 
+installation of comprehensive upgrades. As with the naval sites, DOE supported sustainment 
+activities at these facilities through June 2013. 
+
+Congress appropriated $367.6 million for security upgrades at Russian Navy sites and $675 
+million for security upgrades at SRF sites between FY2002 and FY2012. Funding for the naval 
+sites declined in the mid-2000s, after much of the work was completed, but, as Table 3 below 
+indicates, it increased towards the end of the decade in support of the sustainment activities. The 
+Obama Administration requested $39.9 million in FY2013 to support sustainability and training 
+programs and the replacement of outdated equipment at eight sites. Funding for the SRF sites 
+peaked at $152.8 million in FY2007, in response to the agreement between President Bush and 
+President Putin to accelerate security upgrades at warhead storage facilities. It then declined to 
+$34.4 million in FY2009. The decline reflects the completion of most of the work on upgrades 
+and a shift to sustainment. 
+
+As with the budget for naval sites, the budget for SRF sites increased in FY2010-FY2012 to 
+support the expanded sustainment program and training programs at 23 SRF sites and 3 sites of 
+the 12th Main Directorate. The Obama Administration requested only $8.3 million for these 
+projects in FY2013, but funding remained at the FY2012 level of $59.5 million under the 
+Consolidated Further Appropriations Act, 2013 (P.L. 113-6). The decline in requested funding 
+reflected the completion of most of the security efforts and a shift to sustainment programs. The 
+Administration planned to use this funding to support three training and maintenance centers and 
+to replace outdated security equipment at up to 11 sites. 
+
+ 
+
+65 Chivers, C.J. Securing Russian Nuclear Missiles? U.S. Is Set to Say “Done.” New York Times , October 31, 2007. 
+
+ Congressional Research Service 
+
+ 25 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Table 3. DOD and DOE Authorizations for Warhead Storage Security Programs 
+
+(in $ millions) 
+
+ FY2015 
+
+ Program FY2007 
+
+ FY2008 
+
+ FY2009 FY2010 FY2011 FY2012 FY2013 FY2014 
+
+ Request 
+
+Nuclear 
+
+$74.1 $47.6
+
+$24.1 
+
+$15.1
+
+$9.6
+
+na
+
+na 
+
+na 
+
+na
+
+Security 
+Enhancementa 
+Navy 
+
+$17.3 $13.2
+
+$22.7 
+
+$33.9
+
+$34.3
+
+$33.6
+
+$21.8 
+
+na 
+
+na
+
+Complexb 
+Strategic 
+
+$152.8 $121.9
+
+$34.4 
+
+$48.6
+
+$51.4
+
+$59.1
+
+$13.8 
+
+na 
+
+na
+
+Rocket 
+Forcesb 
+Nuclear 
+
+na na na 
+
+na
+
+na
+
+na
+
+na $23.2 
+
+0
+
+Warhead 
+Protection 
+
+ Source: DOD and DOE budget documents. 
+
+a. In FY2012, DOD began to fund this project through the Global Nuclear Security program area, without 
+
+specifying the amount allocated to weapons storage security. Estimates indicate the amount remains below 
+$10 million. 
+
+b. In FY2014, DOE combined these two program areas into a single Nuclear Warhead Protection Program. 
+
+In its FY2014 budget request, DOE combined the funding for these two program areas in a new 
+category called “Nuclear Warhead Protection.” The budget requested $23.2 million for FY2014 to 
+provide training and workshops and to continue upgrades and sustainability initiatives. The 
+decline in funding in recent years reflected the completion of most of the security projects and a 
+shift to sustainment efforts. DOE has not requested any additional funding for this project area in 
+FY2015 because Russia’s MOD will no longer participate in threat reduction activities. 
+
+ Securing and Eliminating Nuclear Materials 
+
+ CTR Fissile Materials Storage 
+
+According to unclassified estimates, Russia inherited more than 30,000 nuclear warheads from 
+the Soviet Union. Russia is dismantling thousands of these warheads and DOD’s CTR program 
+has provided Russia with assistance in improving the long-term security of the fissile materials 
+removed from these weapons. The program helped Russia design and build a highly secure 
+storage facility at Mayak that is intended to provide long-term safe and secure storage for these 
+materials, and it has provided Russia with more than 26,000 containers to hold the fissile 
+materials. This facility is designed to hold the equivalent of fissile material from 25,000 nuclear 
+warheads. The first wing of this building was completed and certified for use in December 200366 
+and the facility began to accept nuclear materials for storage in July 2006. 
+
+ 
+
+66 The United States and Russia no longer plan to construct an expected second wing. U.S. Senate. Committee on 
+Armed Services. Cooperative Threat Reduction Program. Testimony of Lisa Bronson, Deputy Undersecretary of 
+Defense for Technology Security Policy and Counterproliferation. March 10, 2004. 
+
+ Congressional Research Service 
+
+ 26 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Table 4. CTR Authorizations for Fissile Materials Storage 
+
+($ millions) 
+
+ Project 
+
+ Fiscal years 
+
+ Total 
+
+Fissile Material Containers 
+
+FY1992-FY2000 
+
+$82.2 
+
+Storage Facility Design 
+
+FY1993 
+
+$15 
+
+Storage Facility Construction 
+
+FY1994-FY2001 
+
+$387 
+
+ Source: Controlling Nuclear Warheads and Materials: A Report Card and Action Plan , by Matthew Bunn, et al. Project 
+on Managing the Atom. March 2003. 
+
+ DOE Nuclear Materials Security Programs 
+
+Russia also inherited enough plutonium and highly enriched uranium (HEU) for possible use in 
+thousands more warheads. DOE has helped Russia improve security at sites that house 
+considerably more than half of the former Soviet Union’s 600 metric tons of weapons-usable 
+nuclear materials.67 These include 11 sites that are a part of the Rosatom weapons complex and 31 
+civilian sites. Rosatom, like the Department of Energy in the United States, operates and manages 
+Russia’s nuclear weapons complex. More than 80% of these materials are located at the Rosatom 
+sites.68 As was the case at naval sites and SRF sites, DOE installed security upgrades in two 
+phases at these sites. 
+
+The facilities managed by Rosatom house around 500 metric tons of “highly attractive” weapons-
+useable materials.69 The pace of work at these facilities accelerated, during the past decade, with 
+increased funding and increased cooperation from Russia. DOE has also assisted with the 
+installation of security upgrades at 18 civilian nuclear sites throughout the former Soviet Union. 
+These are mainly research facilities that operate nuclear reactors. According to DOE, these sites 
+contain around 40 metric tons of weapons-useable materials. DOE had stated that it has 
+completed rapid and comprehensive upgrades at most of these facilities. 
+
+Congress appropriated more than $765 million for security upgrades at Rosatom sites and $447 
+million for security upgrades at civilian sites between FY2002 and FY2012. Table 5 , below, 
+shows the amount of funds appropriated since FY2007 and the amount requested in FY2015 for 
+these two programs. The Administration has requested $$17.1 million for the Rosatom sites in 
+FY2014, which represents a reduction of nearly 55% from the amount appropriated in FY2014. 
+According to DOE, this funding will support the completion of comprehensive MPC&A upgrades 
+at additional buildings that store and process weapons-usable nuclear materials and allow it to 
+continue to implement a comprehensive sustainability effort at five Russian sites. The reduction 
+in funding from FY2014 is due to the completion of sustainability efforts at two sites in the 
+
+ 
+
+67 U.S. Senate. Committee on Foreign Relations. Statement of Ambassador Linton Brooks. Administrator, NNSA. June 
+15, 2004. See also, U.S. General Accounting Office. Weapons of Mass Destruction. Additional Russian Cooperation 
+Needed to Facilitate U.S. Efforts to Improve Security at Russian Sites. GA)-03-482. Washington, March 2003. p. 4. 
+See also, U.S. Senate, Committee on Armed Services. Statement of Paul M. Longsworth. Deputy Administrator for 
+Defense Nuclear Nonproliferation. March 10, 2004. 
+68 U.S. Department of Energy. FY2004 Congressional Budget Request. Detailed Budget Justifications. February 2003. 
+p. 625. 
+69 Ibid., p. 639. 
+
+ Congressional Research Service 
+
+ 27 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+Russian weapons complex and completed upgrades work in Belarus and sustainability activities 
+in Kazakhstan. 
+
+The Obama Administration did not request any additional funds for the civilian sites program in 
+FY2014 and FY2015, as it now considers the work to be a part of the Materials Consolidation and 
+Civilian Sites program area. 
+
+ Table 5. DOE Authorizations for Nuclear Materials Security Programs 
+
+(in $ millions) 
+
+ FY2015 
+
+ Program FY2007 FY2008 FY2009 FY2010 FY2011 FY2012 FY2013 FY2014 
+
+ Request 
+
+Rosatom 
+
+$94.0 $79.0 $56.1 
+
+$71.5 
+
+$93.3 
+
+$80.7 
+
+$36.4 
+
+$36.4 
+
+$17.2 
+
+(Minatom) 
+Weapons 
+Complex/ 
+
+Weapons 
+Material 
+Protection 
+
+Civilian 
+
+$52.7 $54.2 $35.5 
+
+$63.5 
+
+$53 
+
+$59.1 
+
+$60.1 
+
+na 
+
+na 
+
+Nuclear Sites 
+
+Material 
+
+$23.8 $19.5 $21.6 
+
+$13.6 
+
+$13.9 
+
+$14.3 
+
+$17 
+
+na 
+
+na 
+
+Consolidation 
+and 
+Conversion 
+
+Material 
+
+na na na 
+
+na 
+
+na 
+
+na 
+
+na $132.3 $138.6 
+
+Consolidation 
+and Civilian 
+Sites 
+
+National 
+
+$65.1 $69.6 $54.9 
+
+$68.5 
+
+$60.9 
+
+$60.9 
+
+$50.7 
+
+$37.8 
+
+$32.2 
+
+Programs and 
+Sustainability 
+
+ Source: U.S. Department of Energy. FY2004, FY2005, FY2006, FY2007, FY2008, FY2009, FY2010, FY2011, 
+FY2012, FY2013, FY2014 Congressional Budget Requests. Detailed Budget Justifications. 
+
+ Material Consolidation and Conversion 
+
+DOE’s Materials Consolidation and Conversion Program supports efforts to consolidate Russian 
+nuclear materials at sites where installation of enhanced security systems have already been 
+completed. It has also funded efforts to convert these materials to forms that might be less 
+attractive to nations seeking materials for nuclear weapons. Congress appropriated $243.4 million 
+for this program area between FY2002 and FY2012. The Obama Administration requested an 
+additional $17 million in FY2013. 
+
+In FY2014, DOE combined this program with MPC&A efforts at civilian sites program in a new 
+Materials Consolidation and Civilian Sites program. It requested $132.3 million for this new, 
+combined program in FY2014. This represents a significant increase of $58.9 million from the 
+combined level of around $73 million in FY2013. It also requested $138.5 million in FY2014. In 
+its budget request, DOE noted that it had combined the programs to reflect better how they were 
+managed within DOE. According to the budget request, the added funding will allow DOE to 
+expand the scope of its efforts in Russia and to support MPC&A activities with countries of 
+
+ Congressional Research Service 
+
+ 28 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+concern outside Russia. The increase in funding will also allow DOE to provide additional 
+support projects in former Soviet states outside Russia. 
+
+ National Programs and Sustainability 
+
+The MPC&A budget has also supported an effort to build an infrastructure within Russia that can 
+operate effectively and be sustained after the initial and comprehensive upgrades are complete. 
+These efforts include developing regulations, inspection capabilities, site safeguards, security 
+programs, and other accounting capabilities. The program operates regional technical support 
+facilities that can repair and maintain equipment and develop training programs for participants. 
+
+Congress appropriated $586.7 million for this program area between FY2002 and FY2012. The 
+Administration requested, and Congress appropriated $37.8 million for this program area for 
+FY2014. The Administration has also requested $32.3 million for FY2015. According to DOE, 
+this funding will support projects that develop the necessary training and maintenance 
+infrastructure for sustaining long-term MPC&A operations in Russia and other countries. 
+
+ Nuclear Security Centers of Excellence 
+
+The DOD CTR program, DOE International Material Protection and Cooperation (IMPC) 
+program, and the State Department are coordinating efforts to help establish Nuclear Security 
+Centers of Excellence (COEs) around the world. This initiative was part of the commitments 
+made by several countries at the 2010, 2012, and 2014 Nuclear Security Summits. These centers 
+are designed to enhance a country’s ability to train personnel, consistent with “international best 
+practices, for nuclear security, material control, inventory management, transport security, and 
+other activities important to improving nuclear material security.”70 DOE has provided technical 
+support to Nuclear Security Centers of Excellence in Japan and South Korea. The United States is 
+also supporting the establishment of the Center of Excellence on Nuclear Security in Beijing, 
+China, and nuclear security engagement with India, “with the goal of developing a partnership 
+through India’s planned Global Centre for Nuclear Energy Partnership.”71 Both of these countries 
+had not previously engaged in bilateral nuclear security efforts with the United States. Current 
+activities emphasize nuclear material security best practices through workshops and training. 
+
+No specific funding amounts were provided in FY2015 congressional budget documents. 
+However, Congress in the past has requested additional information on these programs and 
+limited funding amounts. Section 1304 of the FY2012 National Defense Authorization Act limits 
+the use of FY2012 DOD CTR funds for Centers of Excellence in non-former Soviet Union (FSU) 
+countries. Not more than $500,000 may be obligated or expended in establishing such Centers in 
+non-FSU countries until Congress receives a report on the location, purpose, and funding plan for 
+the center. This limitation was renewed for FY2013, but not FY2014. The DOD Global Nuclear 
+Security request totaled was $20.7 million for FY2015. The DOE request for the IMPC program, 
+of which COE work is a part, was $138,6 million, but agency budget requests do not provide 
+specific funding estimates for the COEs within those larger programs. 
+ 
+
+70 U.S. Department of Defense, Fiscal Year 2014 Budget Estimates, Cooperative Threat Reduction Program , 
+Washington, D.C., April 2013, pp. 103-105, http://comptroller.defense.gov/defbudget/fy2014/budget_justification/pdfs/
+01_Operation_and_Maintenance/O_M_VOL_1_PART_2/CTR_OP-5.pdf. 
+71 Department of Defense, Cooperative Threat Reduction Program , Annual Report to Congress Fiscal Year 2013, 
+Washington, D.C, March 2013, pp. 17-18. 
+
+ Congressional Research Service 
+
+ 29 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Global Threat Reduction Initiative (GTRI) 
+
+Since it was established in 2004, DOE/NNSA’s Global Threat Reduction Initiative (GTRI) has 
+worked to secure, protect, and in some cases, remove vulnerable nuclear and radiological 
+materials at civilian facilities worldwide. The United States established this program primarily to 
+address the threat of terrorists obtaining nuclear material that could be used in a nuclear or 
+radiological device. 
+
+Research reactors all over the world have used weapons-usable nuclear material for fuel as a 
+legacy of U.S. and Soviet technology transfers from the Cold War era. GTRI repatriates U.S. and 
+Russian-origin highly enriched uranium (HEU) spent and fresh nuclear fuel from these research 
+reactors located in third countries. In some cases, the United States converts those reactors to 
+operate with low-enriched uranium (LEU) fuel, which is not useful for a nuclear weapon. In 
+addition, GTRI installs physical security upgrades at nuclear and radiological sites, and recovers 
+disused and unwanted radioactive sources at home and abroad. 
+
+The GTRI budget increased from a request of $131.2 million in FY2008 to $424 million in 
+FY2014, before declining to a request of $333.8 million for FY2015. The early increases were 
+partly due to congressional support for the program, agreements from other countries on material 
+removal and reactor conversion, and high-level emphasis on this work by the Bush 
+Administration’s Bratislava Initiatives—which sped up work with the Russians—and the Obama 
+Administration’s global nuclear security agenda—which spurred more countries to remove and 
+secure material. Overall, the FY2015 request, like the FY2014 request, represents a decrease in 
+funding. Within that budget, funding for conversion of highly enriched uranium (HEU)-fueled 
+reactors saw a proposed decrease in the FY2015 request to develop fuel for medical isotope 
+production without the use of HEU. The “Nuclear and Radiological Material Removal” and 
+“Nuclear and Radiological Material Protection” subprograms also saw decreases from the 
+FY2013 levels, although in FY2014 these programs were organized differently than in previous 
+years, divided into domestic and foreign work. The FY2015 request returns to the original 
+formulation of protection or removal. The Administration has explained the program decrease by 
+saying that the program is accomplishing its goals, and therefore there is less material to be 
+removed. Critics view the decrease as a sign that the Administration is giving this program a 
+lower priority. Other critics urge additional funds be given for radiological security projects in the 
+United States. International donors have contributed to GTRI activities in the past. 
+
+ Table 6. DOE Authorizations for Global Threat Reduction Initiative 
+
+(in $ millions) 
+
+ FY14 
+
+ FY15 
+
+ FY07 
+
+ FY08 
+
+ FY09 
+
+ FY10 
+
+ FY11 
+
+ FY12 
+
+ FY13 
+
+ 
+
+ Enacted 
+
+ Request 
+
+ Global 
+
+$131.23 
+
+$193.22 
+
+$404.64 
+
+$333.5 
+
+$444.69 
+
+$503.45 
+
+$462.89 
+
+$442.1 
+
+$333.49 
+
+ Threat 
+Reduction 
+
+HEU Reactor 
+
+$32.09 $33.82 $76.71 $102.77 $100.97 $139.54 
+
+$146 
+
+$162 
+
+$122.4 
+
+Conversion 
+
+Nuclear and 
+
+$51.49 $67.76 $182.76 $144.83 $221.30 $221.05 
+
+$172 
+
+na 
+
+$101.8 
+
+Radiological 
+Material 
+Removal 
+
+ Congressional Research Service 
+
+ 30 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ FY14 
+
+ FY15 
+
+ FY07 
+
+ FY08 
+
+ FY09 
+
+ FY10 
+
+ FY11 
+
+ FY12 
+
+ FY13 
+
+ 
+
+ Enacted 
+
+ Request 
+
+Nuclear and 
+
+$45.91 $91.65 $135.53 $85.89 $113.72 $137.41 $142.6 
+
+na 
+
+$109.3 
+
+Radiological 
+Material 
+Protection 
+
+International 
+
+na na na na na na na $200.1 na 
+
+Nuclear and 
+Radiological 
+Material 
+Removal and 
+Protection 
+
+Domestic 
+
+na na na na na na 
+
+na $80 na 
+
+Radiological 
+Material 
+Removal and 
+Protection 
+
+Funds from 
+
+$1.74 0 $9.64 0 $8.71 $5.45 $0.65 
+
+0 
+
+0 
+
+International 
+Contributions 
+
+ Source: DOE Congressional Budget Justifications. 
+
+According to the Department of Energy, GTRI accomplishments since May 2004 include the 
+following:72 
+
+• Successfully converted to LEU fuel or verified the shutdown of 49 HEU research 
+
+reactors in 25 countries, including Argentina, Australia, Bulgaria, Canada, Chile, 
+China, the Czech Republic, France, Germany, Hungary, India, Japan, 
+Kazakhstan, Libya, the Netherlands, Portugal, Poland, Russia, Ukraine, the 
+United Kingdom, United States, Uzbekistan, and Vietnam; and verified the 
+cessation of the use of HEU targets for isotope production in Indonesia. 
+
+• Accelerated the establishment of a reliable supply of the medical isotope 
+
+molybdenum-99 (Mo-99) produced without HEU by establishing partnerships 
+with South Africa, Belgium, and the Netherlands to convert Mo-99 production 
+from HEU targets to LEU targets, and with four domestic commercial entities to 
+produce Mo-99 in the United States with non-HEU technologies; 
+
+• Removal of 4,100 kg of highly enriched uranium and plutonium. 
+• Complete removal of HEU from 23 countries: Austria, Brazil, Bulgaria, Chile, 
+
+Colombia, Czech Republic, Denmark, Greece, Latvia, Libya, Mexico, 
+Philippines, Portugal, Romania, Serbia, Slovenia, South Korea, Spain, Sweden, 
+Taiwan, Thailand, Turkey, and Ukraine. 
+
+• Recovery of more than 32,000 disused and unwanted radiological sources 
+
+domestically; and 
+
+ 
+
+72 “GTRI: Removing Vulnerable Civilian Nuclear and Radiological Material,” Fact Sheet, April 12, 2013, 
+http://nnsa.energy.gov/mediaroom/factsheets/gtri-remove; “GTRI: Reducing Nuclear Threats,” Fact Sheet, May 29, 
+2014, http://nnsa.energy.gov/mediaroom/factsheets/reducingthreats. 
+
+ Congressional Research Service 
+
+ 31 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+• Recovery of more than 750 radioisotope thermoelectric generators (RTGs) 
+
+internationally. 
+
+ Securing Borders and Improving Export Controls 
+
+Preventing the smuggling or illegal export of nuclear, biological, or chemical weapons-related 
+materials and technology is a key proliferation challenge. Several U.S. threat reduction and 
+nonproliferation programs seek to strengthen border controls and improve export control systems. 
+Originally, such programs were established in response to concerns over the collapse of political 
+control along the Soviet-era borders. Today, the Departments of State, Defense, Energy, and 
+Homeland Security all manage cooperative programs with countries worldwide to prevent the 
+illicit transfer of WMD technology. 
+
+ Export Control and Related Border Security Assistance 
+
+The State Department’s Export Control and Related Border Security Assistance (EXBS) program 
+helps nations improve their ability to interdict nuclear smuggling and stop the illicit trafficking of 
+all materials for weapons of mass destruction, along with dual use goods and technologies. 
+According to the State Department, the program “builds capacity to ensure that transfer 
+authorizations support only legitimate trade, and to detect and interdict illicit transfers at 
+borders.”73 
+
+When designing a nation-specific plan for border control assistance, the United States seeks to 
+address four key areas. First, if needed, it helps the recipient nation establish the legal and 
+regulatory basis for effective export controls. It then helps the nation develop appropriate export 
+licensing procedures and practices. Third, the United States helps the recipient establish and 
+enhance effective enforcement capabilities. When needed, it provides the recipient with detection 
+and interdiction equipment and training. Finally, the United States helps establish procedures that 
+promote effective interaction between government and industry so that business entities in the 
+recipient nation will abide by the laws and regulations of the new export control regime. 
+
+During the late 1990s and early 2000s, most of the funding for the EXBS program went to 
+projects along the periphery of the former Soviet Union. However, in the past decade, this pattern 
+has changed as the EXBS program has expanded its reach around the globe.74 For example, in 
+FY2005, approximately half of the $38 million spent on EXBS was allocated to projects in the 
+former Soviet states, with the rest going to other nations around the world. By FY2010, when the 
+Obama Administration requested $55 million for EXBS, less than $4 million was allocated to 
+projects in the former Soviet Union. The same is true of the budget for FY2011 and FY2012; the 
+State Department requested $61 million in each year, but allocated only a fraction to the former 
+Soviet Union. The FY2013 budget request sought $55 million for EXBS, but the continuing 
+resolution held the funding at the FY2012 level of $60.1 million. The Obama Administration has 
+sought $54 million for FY2014 and $57 million for FY2015. 
+
+ 
+
+73 U.S. Department of State, Function 150 and Other International Programs , Executive Budget Summary, 
+Washington, D.C., April 2013, p. 115, http://www.state.gov/documents/organization/207305.pdf. 
+74 U.S. Senate. Committee on Foreign Relations. Testimony of John S. Wolf. Assistant Secretary of State for 
+Nonproliferation. March 19, 2003. 
+
+ Congressional Research Service 
+
+ 32 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Nuclear Smuggling Outreach Initiative (NSOI) 
+
+The Nuclear Smuggling Outreach Initiative is a State Department-led initiative meant to 
+strengthen a country’s capacity to detect, interdict, and prosecute any nuclear trafficking 
+incidents. This program had originally focused primarily on the former Soviet Union and Eastern 
+Europe, but its partner countries now include a wide range of states, including the Democratic 
+Republic of the Congo, Algeria, Turkey, Saudi Arabia, and Afghanistan.75 The NSOI also partners 
+with other donor countries and organizations, including Canada, the Czech Republic, the 
+European Union, Finland, France, Germany, International Atomic Energy Agency, Japan, the 
+Netherlands, New Zealand, Norway, South Korea, Sweden, the United Kingdom, and the U.N. 
+Office on Drugs and Crime. This program is funded through the State Department’s WMD 
+Terrorism program, which manages projects that are designed “to improve international capacities 
+to prepare for and respond to a terrorist attack involving weapons of mass destruction.” The 
+Obama Administration has requested $5 million for the WMD Terrorism program area for 
+FY2013 and FY2014, and $4.8 million for FY2015. This includes funding for NSOI and a related 
+activity, the Global Initiative to Combat Nuclear Terrorism. 
+
+ Proliferation Prevention 
+
+In 2003, the Bush Administration added a border security effort to DOD’s CTR program. 
+Through the Proliferation Prevention Program, the United States has cooperated with the military 
+establishments, internal security forces, border guards, and custom forces in Kazakhstan, Ukraine, 
+Uzbekistan, Azerbaijan, Georgia, and Moldova to improve their border controls, with a focus on 
+the Black Sea region. DOD also helped Ukraine establish a comprehensive WMD monitoring and 
+interdiction capability along its border with Moldova. CTR completed the radiation portal 
+monitoring program in Uzbekistan in 2008. The program also assisted Kazakhstan and Azerbaijan 
+to develop a comprehensive capability for WMD surveillance and interdiction along their Caspian 
+Sea borders. 
+
+These programs are intended to help these nations deter, detect, and interrupt the unauthorized 
+movement of weapons or related materials across their borders. While the original focus was non-
+Russian FSU states, the program began in FY2012 to partner with countries in Southeast Asia, 
+along the Straits of Malacca and the South China Sea. In FY2013, the Proliferation Prevention 
+program began to work with states in the Middle East by training and equipping border security 
+staff in Jordan, Iraq, Turkey, and other countries. DOD plans to continue to work with these 
+countries in FY2014 to prevent proliferation of WMD across borders shared with Syria. In 
+addition, Secretary Hagel told the Senate Armed Services Committee at a hearing on April 17, 
+2013, that approximately $70 million was being spent on projects in Jordan to prevent the transfer 
+of weapons of mass destruction across its 256-kilometer border with Syria. 
+
+The George W. Bush Administration requested, and Congress appropriated between $40 million 
+and $60 million for this program each year through FY2009. In addition, in FY2008, Congress 
+added $10 million to the Administration’s request, which the Bush Administration used to expand 
+the reach of the Proliferation Prevention Program to nations outside the former Soviet Union. As 
+a result of this expansion, the budget for the WMD proliferation prevention program grew to 
+between $80 million and $120 million per year in recent years. Funding for the Proliferation 
+Prevention Program decreased to $87.3 million in FY2013, but increased to $110.4 million in 
+ 
+
+75 See also http://www.nsoi-state.net/. 
+
+ Congressional Research Service 
+
+ 33 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+FY2014, in part to support the project in Jordan mentioned above. With the completion of this 
+project, the request for FY2015 has declined again, to $40.7 million. 
+
+ Second Line of Defense 
+
+The Second Line of Defense (SLD) program seeks to improve nuclear smuggling detection 
+capabilities at international borders. This program has two parts, the Second Line of Defense 
+Core Program and the Megaports Program. While the SLD Core program began with projects at 
+the borders of the former Soviet Union, both of these programs now work with partner countries 
+around the world, at the invitation of the partner country. 
+
+Under the SLD Core program, DOE places detection equipment at ports of entry, international 
+border crossings, and other designated points of entry and exit, to detect illicit transport of nuclear 
+materials at international borders. After installation, DOE works with the country on 
+sustainability, then, ultimately, transfers responsibility for upkeep to the host country. SLD 
+“strengthens the capability of foreign governments to deter, detect, and interdict illicit trafficking 
+in nuclear and other radioactive materials across international borders and through the global 
+maritime shipping system.” It also helps train law enforcement officials in the use of the 
+equipment installed at borders. According to DOE, the SLD Core program has signed agreements 
+with 24 countries under which it will provide fixed and mobile radiation detection systems at 
+borders. By the beginning of 2013, it had “completed over 449 priority sites and deployed 34 
+mobile systems to 11 countries.”76 
+
+In FY2004, Congress added $28 million to the Second Line of Defense program for a project 
+known as the Megaports initiative. This project is developing and deploying radiation detectors 
+for use at the largest foreign seaports that handle about 70% of the container traffic headed for the 
+United States.77 Megaports is designed “to detect the trafficking of nuclear or radioactive 
+materials in the world’s busiest seaports.” According to DOE, the Megaports Initiative has signed 
+agreements with 35 partner countries. 
+
+DOE conducted a strategic review of the SLD program in FY2013 to determine the most 
+effective approach to closing key gaps in the global nuclear detection architecture and to increase 
+the impact of detection and deterrence using fixed and mobile deployments. According to DOE, 
+the review recommended a plan to address remaining fixed detection gaps, expand mobile 
+detection, and fully fund sustainability. The review also resulted in the reorganization of SLD 
+Core and Megaports Programs under a joint implementation program and sustainability effort 
+funded in one SLD subprogram. 
+
+The funding appropriated for the SLD Core Program and Megaports appears in Table 7 . The 
+funding requested for these two programs declined from $271 million in FY2013 to $190 million 
+in FY2014. The request declines again in FY2015, to $117.7 million. According to DOE, the 
+decline in funding between FY2014 and FY2015 is due to both a one-time funding increase in 
+FY2014 to support a key detection program and adjustments that were made in FY2015 due to 
+the need to fund higher NNSA priorities. 
+ 
+
+76 Department of Energy, FY2014 Budget Request, National Nuclear Security Administration , Washington, D.C., April 
+2013, pp. DN-107, http://energy.gov/sites/prod/files/2013/04/f0/Volume1.pdf. 
+77 Hoehn, William. Update on Legislation Affecting U.S-Former Soviet Union Nonproliferation and Threat Reduction . 
+RANSAC. November 17, 2003. 
+
+ Congressional Research Service 
+
+ 34 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Table 7. DOE Funding for Second Line of Defense and Megaports 
+
+ FY2015 
+
+ Program FY2007 FY2008 FY2009 FY2010 FY2011 FY2012 FY2013 FY2014 
+
+ Request 
+
+Second Line 
+
+$75.8 $136.0 $71.9 $78.4 
+
+$140.3 $129.4 
+
+na 
+
+na 
+
+na 
+
+of Defense 
+Core 
+Program 
+
+Megaports $116.1 $130.8 $102.9 $194 
+
+$194 
+
+134.4 
+
+na 
+
+na 
+
+na 
+
+Total: 
+
+SLD $191.9 $266.8 $174.8 $272.4 
+
+$334.3 
+
+$263.8 
+
+$272 
+
+$190 
+
+$117.7 
+
+ Source: DOE budget documents. 
+
+ Note: The FY2013-FY2015 budgets include a single line for both the SLD core program and Megaports. 
+
+ Container Security Initiative and Secure Freight Initiative 
+
+Two overarching Department of Homeland Security (DHS) initiatives, the Container Security 
+Initiative and the Secure Freight Initiative, work to increase the likelihood that nuclear material or 
+a nuclear weapon would be identified and interdicted during shipping. DHS works closely with 
+the DOE Megaports Initiative. 
+
+The Department of Homeland Security Customs and Border Patrol (CBP) implements the 
+Container Security Initiative (CSI), which works with foreign customs authorities “to target and 
+examine U.S.-bound high-risk cargo while it is still at foreign ports.”78 CSI is operational in 58 
+ports worldwide, screening over 80% of the maritime cargo bound for the United States, 
+according to the program’s website. DHS funded this program at $81 million in FY2012 and $75 
+million in FY2013. It requested an additional $72 million for FY2014, but received only $67.5 
+million. It has requested an additional $69.2 million for FY2015. 
+
+The Secure Freight Initiative is jointly implemented with the Department of Energy. It gives 
+additional capacity to select CSI ports. SFI installs detection and communications equipment at 
+foreign seaports. DOE and DHS share the costs for this program. DHS installs communications 
+infrastructure at the partner port that would transmit any alarm data to the United States, and 
+cooperates with local authorities to resolve any alarms. 
+
+ Chemical Weapons Destruction 
+
+During the Cold War, the Soviet Union amassed the largest stockpile of chemical weapons in the 
+world. After becoming a party to the Chemical Weapons Convention (CWC), Russia declared that 
+this stockpile contained 40,000 metric tons of chemical weapons. Russia has stored these 
+weapons at seven sites—five sites contain nerve agents in bombs and artillery shells while three 
+of these sites and two additional sites house bulk stocks of blister agents.79 Under the CWC, 
+Russia committed to eliminate the stocks by 2012, but it has not met that deadline and has 
+contended that it lacks the financial resources to do so.80 As a result, the international community 
+ 
+
+78 http://www.cbp.gov/xp/cgov/trade/cargo_security/csi/. 
+79 U.S. General Accounting Office. Weapons of Mass Destruction: Additional Russian Cooperation Needed to 
+Facilitate U.S. Efforts to Improve Security at Russian Sites . GAO-02-482. March 2003. pp. 58-59. 
+80 The United States also has not met its destruction deadlines under the CWC. The OPCW has extended the deadline 
+(continued...) 
+
+ Congressional Research Service 
+
+ 35 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+has provided Russia with a significant amount of assistance in eliminating its chemical weapons. 
+A European consortium, led by Germany, has constructed a destruction facility at Gorny to 
+destroy the blister agent stored there.81 Russia now plans to complete destruction by December 
+2015. 
+
+The United States, with funding provided by DOD’s CTR program, assisted Russia with the 
+design and construction of a chemical weapons destruction facility at Shchuch’ye until July 2013. 
+The chemical weapons storage facility at Shchuch’ye contains nearly half of Russia’s stockpile of 
+artillery shells filled with nerve agent.82 The CTR-financed destruction facility is intended to 
+destroy these stocks and those stored at the other four storage sites, an amount estimated to be 
+around 5,450 metric tons. 
+
+The majority of DOD’s roughly $1 billion in Russian chemical weapons destruction CTR funding 
+has supported the design and construction of the destruction facility at Shchuch’ye, as well as the 
+installation of equipment and training of operating personnel at the facility. Construction on the 
+Shchuch’ye facility began in March 2003. The United States and Russia had hoped that 
+construction would be completed and the facility would begin operations by the end of 2008. 
+Because it would then take around 3.5 years to destroy the stocks of nerve agent, this schedule 
+would have allowed Russia to meet the 2012 deadline. This schedule slipped, however, and the 
+process has been slower than planned. The facility began operations in March 2009. 
+
+Although major construction projects have been completed in recent years, DOD requested 
+funding for “technical and procurement advice and assistance support” at Shchuch’ye until July 
+2013. The CTR program also provided technical support and design advice to Russia’s chemical 
+weapons destruction facility at Kizner. This facility began operations in late 2013 and will destroy 
+5,645 metric tons of nerve agent. The FY2015 budget request does not ask for any funds for 
+chemical weapons destruction technical support in Russia. 
+
+In addition, the CTR program has helped Albania destroy all its chemical weapons stocks and is 
+now assisting the government of Libya with the elimination of legacy chemical weapons and 
+agents from the Qadhafi era. According to the FY2015 budget estimate, CTR is “providing safety 
+and security improvements to the Ruwagha Chemical Weapons Storage Facility in the form of 
+physical upgrades, and ongoing destruction operations.” The CTR program partners with the 
+German government on these efforts. 
+
+The most significant new activity for the CWD program in FY2014 was preparations for the 
+destruction of Syrian chemical weapons and in-kind assistance to international inspectors. The 
+largest contribution to the international effort has come from the DOD CTR program. On April 8, 
+Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction Rebecca 
+K.C. Hersman said that the CTR program had allocated $160 million to support the CW 
+elimination effort. Since the bulk of this funding was spent preparing the MV Cape Ray and 
+
+ 
+(...continued) 
+for both nations. 
+81 For a description of this facility and program see Glasser, Susan B. “Cloud Over Russia’s Poison Gas Disposal.” 
+ Washington Post . August 24, 2002. p. 1 
+82 The Department of Defense estimates this to be 5,460 metric tons of agent in nearly 2 million rocket and artillery 
+warheads. See U.S. Department of Defense. Fiscal Year 2004/2005 Biennial Budget Estimates. Former Soviet Union 
+Threat Reduction Appropriation. February 2003. p. 4 
+
+ Congressional Research Service 
+
+ 36 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+equipping inspectors, the budget request for FY2015 is less than what was spent this past year—
+$15.7 million for technical expertise and resources to support the U.N.-OPCW Joint Mission in 
+FY2015, as well as continuing efforts in Libya. According to DOD, the decrease compared to 
+FY2014 is due to the expiration of the Umbrella Agreement, which means there is no longer any 
+cooperation between the U.S. and Russia on chemical weapons destruction activities. The bulk of 
+spending that is expected for efforts in Syria was paid for in FY2013 and FY2014. 
+
+ Table 8. CTR Funding for Chemical Weapons Destruction 
+
+(in $ millions) 
+
+ FY15 
+
+ FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 
+
+ 
+
+ Request 
+
+47,700 $1 $28 $8 $12 $9.8 $69 $83 $15.7 
+
+ Source: DOD Congressional Budget Estimates. 
+
+ Cooperative Biological Engagement 
+
+The DOD CTR biological threat reduction program has evolved over the past 20 years. It has 
+expanded financially, growing from less than 10% of the CTR budget in the late 1990s to over 
+60% in the FY2015 budget request. It also has expanded geographically. It began as a program 
+focused on dismantling the vast biological weapons complex that Russia inherited from the 
+Soviet Union, but has now become a tool that the United States uses to promote “best practices” 
+in physical security and safety at biological laboratories with dangerous pathogens, and to 
+develop disease surveillance systems on several continents, particularly Southeast Asia and sub-
+Saharan Africa. The name has also changed, from Biological Threat Reduction (BTR) to 
+Cooperative Biological Engagement (CBE), to reflect the sensitivity of new partner countries to 
+being termed a “threat.” The Department of State also funds bio-security programs, managing 
+those that address scientist training, best practices, and industry partnerships under the Global 
+Threat Reduction’s Biosecurity Engagement Program (see “Securing Knowledge and Expertise” 
+section, below). Congress has also been concerned about measuring the effectiveness of these 
+programs in reducing threats. Section 1303 of the FY2012 NDAA set a limitation on funds for the 
+Cooperative Biological Engagement (CBE) Program—“not more than 80 percent may be 
+obligated or expended”—until certifications by the Secretary of Defense are sent to Congress 
+regarding the effectiveness of the CBE program. 
+
+The shift in CTR’s biological weapons programs mirrors a similar shift in focus for CTR 
+programs overall, from a focus on threat reduction in the former Soviet Union to the prevention 
+of WMD terrorism from any source world-wide. The Obama Administration has stated that the 
+goal of the CBE program is to counter the “threat of state and non-state actors acquiring 
+biological materials and expertise that could be used to develop or deploy a biological weapon.” 
+The program does this by destroying or securing biological agents (“Select Agents”) at their 
+source and building the capacity to detect, diagnose, and report a disease outbreak.83 The 2009 
+National Strategy for Combating Biological Threats emphasized the need for global health 
+
+ 
+
+83 Select Agents are determined by the Center for Disease Control, and defined by law as biological agents or toxins 
+“which have the potential to pose a severe threat to public, animal or plant health.” For more information, see 
+http://www.selectagents.gov and the White House page on Biosecurity, http://www.whitehouse.gov/administration/eop/
+ostp/nstc/biosecurity. 
+
+ Congressional Research Service 
+
+ 37 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+security and best practices. As a result, DOD’s CTR program works with several federal agencies, 
+other donor countries, international organizations, and the private sector to implement this 
+approach. 
+
+ Biological Threat Reduction (BTR) in Russia 
+
+Since CTR’s inception, Congress and the executive branch have sought to address the challenges 
+posed by the potential proliferation of biological weapons and materials from Russia.84 This was a 
+particular concern because the Soviet Union reportedly developed the world’s largest biological 
+weapons program, employing, at its peak, an estimated 60,000 people at more than 50 sites. This 
+weapons complex developed a broad range of biological pathogens for use against plants, 
+animals, and humans.85 Russia reportedly continued to pursue research and development of 
+biological agents into the 1990s, even as the security systems and supporting infrastructure at its 
+facilities began to deteriorate. The United States began to provide Russia with CTR assistance to 
+improve safety and security at its biological weapons sites and to help employ biological weapons 
+scientists during the late 1990s, even though Russia had not provided a complete inventory of the 
+sites or people involved in biological weapons work.86 The problem was aggravated by the fact 
+that Russia reduced the size of its complex in the mid-1990s, leaving many scientists potentially 
+unemployed or underemployed. Biological pathogens are easily transported, further increasing 
+the proliferation risk.87 
+
+The CTR program supported four separate BTR programs in Russia, working at dozens of sites 
+that include many weapons facilities: the Biological Weapons Infrastructure Elimination program, 
+the Biosecurity and Biosafety program, the BW Threat Agent Detection and Response program, 
+and Cooperative Biodefense Research. DOD has funded physical security upgrades at a small 
+number of facilities. Russia has not agreed to allow access or joint work at several key military 
+biological facilities, which has limited the scope of these programs. Many projects, such as 
+cooperative biodefense research, have been implemented through the International Science and 
+Technology Centers (ISTC), because DOD had been unable to conclude implementing 
+agreements with the relevant ministries in Russia.88 The Russian government has closed the 
+Moscow ISTC, so no new projects in Russia are now planned through that mechanism. 
+
+The FY2014 CTR budget request says that “activities are limited in Russia and Uzbekistan due to 
+both countries’ reluctance to cooperate with the DoD Cooperative Biological Engagement (CBE) 
+Program.” This appears to still be a priority for the Obama Administration, and officials have said 
+they will continue to make attempts to cooperate on these issues, particularly through the Russian 
+
+ 
+
+84 “The security of existing pathogen libraries, the past scope of work, the current whereabouts of BW and BW-related 
+experts, and the future disposition of the FSU biological weapons capability are all critical concerns within the threat 
+reduction agenda.” Reshaping U.S.-Russian Threat Reduction: New Approaches for the Second Decade. Carnegie 
+Endowment for International Peace and Russian American Nuclear Security Advisory Council . November 2002. p. 2. 
+85 For background on the BWPP programs, see CRS Report RL31368, Preventing Proliferation of Biological Weapons: 
+U.S. Assistance to the Former Soviet States , by Michelle Stem Cook and Amy F. Woolf. 
+86 U.S. General Accounting Office. Weapons of Mass Destruction: Additional Russian Cooperation Needed to 
+Facilitate U.S. Efforts to Improve Security at Russian Sites . GAO-02-482. March 2003. pp. 48-49. 
+87 U.S. General Accounting Office. Weapons of Mass Destruction: Additional Russian Cooperation Needed to 
+Facilitate U.S. Efforts to Improve Security at Russian Sites . GAO-02-482. March 2003. pp. 44-46. 
+88 Ibid., p. 54. 
+
+ Congressional Research Service 
+
+ 38 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+Ministry of Agriculture and Ministry of Health. The CTR program is planning to spend $2.4 
+million in FY2015 on CBE programs in Russia. 
+
+ Central Asia and the Caucuses 
+
+The non-Russian states of the former Soviet Union have been willing partners in dismantling the 
+Soviet biological weapons legacy and securing pathogen collections and laboratories. Facilities in 
+these countries were abandoned by the Russian military when the republics became independent 
+states, and in many cases local governments were not aware of their existence or the dangers they 
+housed. 
+
+Of particular note, over time the United States learned of dangerous pathogen collections 
+dispersed throughout the region as part of the Soviet Anti-Plague System consisting of institutes 
+in 11 republics. A decade after the dissolution of the Soviet Union, these facilities lacked security 
+and safety measures, they had lost expert staff due to economic conditions, and many were in a 
+state of disrepair. The United States accelerated its assistance to these facilities starting in the late 
+1990s. The CTR Biological Threat Reduction program (now CBE) has supported activities in 
+Azerbaijan, Georgia, Kyrgyzstan, Ukraine, Uzbekistan, Armenia, and Kazakhstan, where the 
+Soviet Union housed much of its biological weapons production complex. For example, CTR 
+funding helped destroy the large-scale biological weapons production facility in Stepnogorsk, 
+Kazakhstan, and assisted in decontaminating the open-air BW testing site at Vozrozhdeniye Island 
+in the Aral Sea, Uzbekistan. 
+
+The CTR program has built a secure Central Reference Laboratories (CRL) for pathogen 
+collections in Ukraine and Kazakhstan, and is constructing a CRL in Azerbaijan. Currently, the 
+CTR program has completed upgrades at 39 “Secured Labs” in Armenia, Georgia, Kazakhstan, 
+and Ukraine. DOD continues to support upgrades and training at these facilities.89 
+
+CTR will continue to work in this region to improve security and disease surveillance. Central 
+Asia is a region that experiences natural disease outbreaks, such as plague, brucellosis, and 
+Crimean-Congo hemorrhagic fever, as well as zoonotic diseases. As many of the scientists from 
+the Soviet era retire, a new generation of experts will need to step up to manage the public health 
+and biosecurity programs in these states, which have limited resources. In addition, the region 
+around the former Soviet Union has experienced an increase in militant Islamic groups, raising 
+concerns about terrorist access to biological pathogens at facilities in the FSU. 
+
+According to the FY2015 DOD CTR budget request, DOD plans to continue bio-engagement 
+efforts in the former Soviet Union as follows (FY2015 funds executed over three years, a 
+breakdown of budget numbers by region is not given). 
+
+In the biosafety and biosecurity field: 
+
+• continue biosafety and security (BS&S) upgrades to human and veterinary 
+
+laboratories in Armenia and Ukraine; 
+
+• complete construction of the CRL in Kazakhstan; 
+
+ 
+
+89 Fiscal Year 2014 Budget Estimates Cooperative Threat Reduction Program, Defense Threat Reduction Agency, 
+April 2013. 
+
+ Congressional Research Service 
+
+ 39 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+• continue oversight on construction of CRL in Azerbaijan and installation of 
+
+BS&S systems and equipment; 
+
+• continue the development and implementation of BS&S Standard Operating 
+
+Procedures across the region; and 
+
+• continue the provision of Biorisk Management training in Armenia, Azerbaijan, 
+
+Kazakhstan, and Ukraine. 
+
+In the field of disease surveillance: 
+
+• continue human and veterinary training in epidemiology, laboratory management, 
+
+and disease diagnosis in Armenia, Azerbaijan, Kazakhstan, and Ukraine; 
+
+• continue research activities in Armenia, Azerbaijan, Georgia, Kazakhstan, Russia, 
+
+and Ukraine; 
+
+• continue support for security upgrades at laboratories in Azerbaijan, Georgia, 
+
+Kazakhstan, and Ukraine; and 
+
+• complete Electronic Integrated Disease Surveillance System (EIDSS) 
+
+implementation, training and upgrades in Armenia, Azerbaijan, Georgia, and 
+Kazakhstan. 
+
+ Global Cooperative Biological Engagement (CBE) 
+
+DOD has also expanded the reach of its CBE program to Africa, Southeast Asia, and the Middle 
+East in recent years. While the majority of CBE partner countries are not and have never been 
+biological weapons producers, they do maintain dangerous pathogen collections for study or have 
+naturally occurring rare infectious or other diseases. Therefore, DOD CTR assesses security and 
+safety at specific facilities; provides training to improve clinical, laboratory, and epidemiological 
+safety and security for specific to dangerous pathogens; and helps countries build a disease 
+surveillance system for early detection of an outbreak. U.S. officials have stressed that this is 
+useful not only for public health reasons but to protect U.S. troops deployed overseas. CBE works 
+with the State Department, USAID, Centers for Disease Control (CDC), and U.S. Combatant 
+Commands. 
+
+According to Defense Threat Reduction Agency Director Kenneth Myers: 
+
+The threat has changed. Because of our success in eliminating access to materials in the 
+former Soviet Union, groups and states seeking WMD have shifted their attention to other 
+geographic areas and potential WMD sources. We are evolving to address these threats and 
+expanding our areas of cooperation to stay one step ahead. In most cases, our new partners 
+have no WMD aspirations. But, pathogens for endemic diseases can be weaponized and are 
+not constrained by geographic or political boundaries. Pathogens for deadly diseases like 
+Ebola, Marburg, and Anthrax that have been used to make biological weapons are being 
+safely secured as part of the Cooperative Biological Engagement Program.90 
+
+ 
+
+90 Statement of Mr. Kenneth A. Myers III on Proliferation Prevention Programs, Emerging Threats and Capabilities 
+Subcommitee, Committee on Armed Services, United States Senate, April 1, 2014. 
+
+ Congressional Research Service 
+
+ 40 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+According to the FY2014 DOD CTR budget request, DOD plans to initiate bio-engagement 
+efforts in “select areas of Africa, Middle East, and Southeast Asia to include regional 
+engagements.” This is to include 
+
+• securing 12 Labs in Afghanistan, Armenia, Iraq, Kazakhstan, Kenya, Pakistan, 
+
+Uganda, Tanzania, and Ukraine; 
+
+• beginning construction and equipment installation of secure pathogen 
+
+repositories to include construction of the National Public Health Laboratory 
+(NPHL) in Afghanistan; 
+
+• conducting facility-specific bio-risk assessments and providing bio-security and 
+
+bio-safety upgrades as required; 
+
+• initiating projects in Africa, Armenia, Azerbaijan, Georgia, Kazakhstan, Russia, 
+
+Pakistan, Ukraine, and other countries; and 
+
+• continuing to build an outbreak surveillance network in Laos, Cambodia, and 
+
+Vietnam. 
+
+ Funding 
+
+Between FY1997 and FY2014, Congress appropriated to DOD around $2.1 billion for biological 
+threat reduction projects, with large increases in the amount of both the request and the 
+appropriation in recent years. Table 9 below displays the funding levels since FY2007. The 
+increase in funding was largest between FY2007 and FY2008, when DOD planned to expand 
+U.S. bio-safety and bio-security assistance at facilities in Kazakhstan, Uzbekistan, and Georgia. 
+This request reflected growing concerns about the threat of biological weapons proliferation. But 
+some believed this increase would not be sufficient. Senator Richard Lugar sought to add $100 
+million for the CTR program in FY2008, with the express purpose of expanding and accelerating 
+biological weapons nonproliferation programs.91 The Senate reduced this amount but still added 
+$50 million to the program for FY2008. 
+
+The requests and authorizations for CBE funding grew steadily since FY2008, with a slight 
+decrease in the FY2015 request. Some in Congress have expressed concern over whether DOD 
+was the appropriate actor to be carrying out these tasks, and whether biological engagement was 
+being pursued at the expense of other programs. The House Armed Services Committee, for 
+example, in its report on the FY2010 Defense Authorization Bill (H.Rept. 111-166) called on 
+DOD to continue its efforts to strengthen the biological threat reduction programs and to pursue 
+more interagency coordination, but also “to maintain a strong focus on … other threat reduction 
+challenges, including preventing the proliferation of chemical and nuclear weapons and weapons-
+related materials, technologies, and expertise.” 
+
+ 
+
+91 Lugar Wants $100 Million Nunn-Lugar Budget Increase. Press Release. Office of Senator Richard Lugar. February 
+5, 2007. 
+
+ Congressional Research Service 
+
+ 41 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Table 9. CTR Funding for Cooperative Biological Engagement 
+
+(in $ millions) 
+
+ FY15 
+
+ FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 
+
+ 
+
+ Request 
+
+$72.36 $174.5 $177.46 $169.13 $209.03 $229.47 $241.01 $260 $256.76 
+
+ Source: DOD Congressional Budget Estimates. 
+
+ Securing Knowledge and Expertise 
+
+After the collapse of the Soviet Union in 1991, many experts feared that scientists from Russia’s 
+nuclear, chemical, and biological weapons programs might sell their knowledge to other nations 
+seeking these weapons. Many of the nuclear weapons scientists had worked in the Soviet Union’s 
+“closed” nuclear cities, where they had enjoyed relatively high salaries and prestige, but their jobs 
+evaporated during Russia’s economic and political crises in the early 1990s. Biological weapons 
+scientists, who were employed at both military and civilian facilities, were left unemployed after 
+the closing of many large BW facilities in the former Soviet republics, while those in Russia saw 
+drastic budget cuts to civilian research science programs. Even those scientists who retained their 
+jobs saw their incomes decline sharply as Russia was unable to pay their salaries for months at a 
+time. 
+
+Both the State Department and the Department of Energy developed programs that were designed 
+to reduce the risk that the weapons scientists would sell their knowledge to the highest bidder. For 
+the first decade or more, these were through short-term grants that were meant to aid scientists 
+into transitioning to civilian scientific research or the private sector. Today, this suite of programs 
+is aimed at preventing terrorists from exploiting scientists, personnel, or materials to develop 
+these weapons. Because of increased attention to the terrorism threat in the past decade, the 
+programs have developed to emphasize “engagement”—shared best practices for physical and 
+personnel security, safety, joint R&D, and exchange of information. The programs also now train 
+not only scientists, but other lab personnel about international security standards and improve 
+personnel reliability programs to address the “insider threat.” 
+
+The State Department’s Global Threat Reduction Program supports the international science 
+centers (described below) and several separate scientist engagement programs: the Biosecurity 
+Engagement Program, the Chemical Security Engagement Program, and the Partnership for 
+Nuclear Security. In the past, these separate programs have worked primarily through the 
+international science centers. These programs have focused on redirecting former weapons 
+scientists to civilian work through grants or industry partnerships. For example, the State 
+Department’s Bio Industry Initiative (BII), which began in 2002, helped Russia reconfigure 
+former BW-related facilities for peaceful research and production, such as work on vaccines, in 
+partnership with U.S. biotech and pharmaceutical companies.92 The current State Department 
+Global Threat Reduction programs as well as the Department of Energy suite of scientist support 
+programs now are focused on security training programs for scientists, and less on grants for 
+scientific or commercial projects, although these types of projects are still funded through the 
+science centers. In recent years, these programs have also shifted grant funding away from 
+
+ 
+
+92 The State Department conducted this program in cooperation with the Department of Health and Human Services 
+(DHHS), Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). 
+
+ Congressional Research Service 
+
+ 42 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+Russia’s nuclear scientists to biological and chemical weapons scientists and expanded assistance 
+to scientists from other former Soviet states. The State and DOE programs have, at the same time, 
+expanded beyond the borders of the former Soviet Union, with programs designed to engage 
+scientists in Iraq and Libya in a more traditional CTR format for those countries’ former weapon 
+scientists; and in other countries such as Indonesia, Yemen, Egypt, and Pakistan emphasizing best 
+practices and security training. The section below provides more detail about the evolution of 
+these programs. 
+
+ The Science Centers 
+
+In late 1992, the United States, Japan, the European Union, and Russia established the 
+International Science and Technology Center (ISTC) in Moscow. Several other former Soviet 
+states joined the center during the 1990s, and other nations, including Norway and South Korea, 
+added their financial support. In late 1993, the United States, Canada, Sweden, and Ukraine 
+established the Science and Technology Center in Ukraine (STCU). Several former Soviet states 
+have also joined this center, and Japan has joined to provide financial support. By early 2010, 39 
+countries were participating in the centers. 
+
+Since its inception, the ISTC has funded 2,702 proposals and awarded grants totaling $836.5 
+million, with the United States providing about $220 million of this total. The funds have 
+supported the work of more than 70,000 former weapons scientists. However, support for the 
+center in Russia has waned.93 In August 2010, Russia’s President Medvedev announced that 
+Russia was withdrawing from participation in the center. Preparations to move the ISTC 
+headquarters to Almaty, Kazakhstan, are underway. No current grants were canceled, but no new 
+grants will be awarded in Russia. Work will continue with the other recipient countries.94 The 
+United States provides support through the ISTC to the Biological Weapons Redirection 
+Program.95 As was noted above, this program provides research grants to Russian biotechnology 
+institutes to redirect scientists to commercial, agricultural, and public health projects. The State 
+Department collaborates with several other U.S. agencies on this program.96 
+
+The STCU gives grants to scientists in Azerbaijan, Georgia, Moldova, Ukraine, and Uzbekistan. 
+While originally focused on just former weapon scientists, the STCU has broadened its eligibility 
+requirements in recent years. Currently, at least 30%-50% of the work force assigned to projects 
+that receive STCU funding must be former weapon scientists. This is partially because so much 
+time has passed since the end of the Cold War, and a decreased number of current scientists have 
+been involved in weapons-related projects. 
+
+ 
+
+93 “Budget Cuts Threaten Support Program for Former Soviet Weapons Experts,” Global Security Newswire , June 19, 
+2009. 
+94 Statement of the 56th Governing Board of the International Science and Technology Center, December 7, 2012, 
+http://www.istc.ru/istc/istc.nsf/va_WebPages/56GB_StatementEng. 
+95 Ibid. 
+96 For more details, see CRS Report RL31368, Preventing Proliferation of Biological Weapons: U.S. Assistance to the 
+Former Soviet States , by Michelle Stem Cook and Amy F. Woolf. 
+
+ Congressional Research Service 
+
+ 43 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Iraq and Libya Scientist Engagement Programs 
+
+Both Iraq and Libya experienced a dramatic change in government while also possessing nuclear 
+and chemical weapons programs, and in the case of Iraq, biological weapons. According to the 
+State Department the Iraq Scientist Engagement Program “engages Iraqi scientists, technicians, 
+and engineers with WMD and weapons-applicable skills to promote Iraqi scientific and 
+technological development.” The Libya Scientist Engagement Program “supports the transition of 
+former Libyan WMD scientists to civilian careers through technological partnerships.” These 
+programs provide “training, travel grants, research and development grants, and technical 
+expertise” to redirect these people away from weapons work and towards peaceful, civilian 
+pursuits. The United States spent a total of $31 million on both of these programs between 
+FY2002 and FY2010.97 
+
+The Iraq Scientist Engagement program grew out of the U.S. effort to eliminate Iraq’s WMD 
+capabilities after the U.S. invasion of Iraq in 2003. At that time, State Department officials began 
+mobilizing an effort to establish a science center in Iraq like those in the former Soviet Union to 
+help “redirect” former WMD scientists in the country. The purpose was to both prevent the 
+proliferation of expertise at a time of great instability, and to channel their technical expertise to 
+reconstruction efforts. This center had great difficulty matching scientists to civilian work, and 
+was phased out along with stipends for scientists.98 As a result, in 2009, the State Department 
+established the Iraqi Scientist Engagement Program. According to the State Department’s FY2013 
+congressional budget justification, this program is working to train scientists and improve 
+security at facilities that house potentially dangerous biological and chemical materials. 
+
+From 2004 to 2010, the State Department Global Threat Reduction program also managed a 
+scientist redirection program in Libya, following Qaddafi’s decision to rid the country of WMD. 
+The Libya Scientist Engagement Program (LSEP) was to support the transition of former WMD 
+scientists in Libya, especially from the Tajoura Nuclear Research Center (TNRC), to civilian 
+work through technological partnerships. From 2004 to 2010, $8 million was spent on LSEP 
+projects. The program paused during the civil war, but the State Department resumed its 
+engagement with Libyan scientists, “with new projects prioritized by threat and coordinated with 
+the new Libyan government and Libyan researchers.” No funds were spent in FY2011; $240,281 
+were spent in FY2012; and approximately $484,000 was spent on the program in FY2013. 
+According to the State Department, this allows the program to promote a nuclear security culture 
+at TNRC and 
+
+enable work with public and animal health laboratories to improve Libyan biorisk 
+management and bolster Libya’s ability to detect and respond to intentional and naturally-
+occurring disease outbreaks caused by potential bioterrorism agents. 
+
+ Department of Energy Programs 
+
+During the 1990s, the Department of Energy initiated programs to help retrain and redirect 
+scientists and engineers who had worked in the Soviet Union’s nuclear weapons enterprise. With 
+these programs, DOE sought to stop the leakage of knowledge out of Russia’s nuclear weapons 
+complex to states or groups seeking their own nuclear weapons. The programs were designed to 
+ 
+
+97 http://www.state.gov/documents/organization/183039.pdf. 
+98 http://www.armscontrol.org/act/2011_%2007-08/%20Securing_WMD_Expertise_Lessons_Learned_From_Iraq. 
+
+ Congressional Research Service 
+
+ 44 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+help Russia reduce the size of its nuclear weapons complex, by removing functions and 
+equipment, and to create “sustainable non-weapons-related work” for scientists through 
+technology projects that have “commercially-viable market opportunities.”99 
+
+These programs have evolved over time, expanding beyond the borders of the former Soviet 
+Union and beyond the nuclear enterprise to address concerns about scientists working with all 
+types of CBRN materials. The name of the program has also changed numerous times over the 
+years. DOE initially established two programs in the 1990s—the Initiatives for Proliferation 
+Prevention (IPP) and the Nuclear Cities Initiative (NCI)—to meet these objectives. In late 2003, 
+the Bush Administration cancelled NCI, and DOE renamed its remaining program the Russian 
+Transition Initiative. The name changed again in DOE’s budget request for FY2006, to the Global 
+Initiatives for Proliferation Prevention (GIPP). This change demonstrated that the program would 
+begin to provide assistance to scientists outside the former Soviet Union. Then, in FY2013, to 
+reflect the overall shift in emphasis away from assistance and towards global engagement, DOE 
+renamed the program Global Security through Science Partnerships (GSSP). This section briefly 
+reviews the history of these programs, and highlights some of the issues that have come up during 
+their implementation. 
+
+ Initiatives for Proliferation Prevention and the Nuclear Cities Initiative 
+
+The Department of Energy began to fund the Initiatives for Proliferation Prevention (IPP) 
+Program in 1994. IPP matched U.S. weapons labs and U.S. industry with Russian weapons 
+scientists and engineers in cooperative research projects with “high commercial potential.” DOE 
+hoped that the focus on commercialization would help make the projects self-sustaining in the 
+long term. The IPP program received $35 million in the FY1994 Foreign Operations 
+Appropriations Act, before its funding moved to the Department of Energy. This initial funding 
+helped establish nearly 200 research projects by 1995. 
+
+The IPP Program was the subject of several critical GAO reports.100 A study released in February 
+1999 noted that nearly half of the appropriated funds for IPP had been spent at the U.S. nuclear 
+weapons labs and that, after subtracting the taxes, fees, and other charges removed by Russian 
+officials, the Russian institutes had received only around one-third of the funds. The report also 
+questioned DOE’s oversight of the programs, noting that program officials did not always know 
+how many scientists were receiving IPP funding. The report also noted that the projects had not 
+yet produced any commercial successes. Congress responded to this criticism by reducing 
+funding for the program and specifying that no more than 35% of the funds be spent at the U.S. 
+labs. It also mandated that the United States negotiate agreements with Russia to ensure that 
+funds provided under this program are not subject to taxes in Russia. Furthermore, it requested 
+that the Secretary of Energy review IPP programs for their commercialization potential. A 
+subsequent GAO report published in 2007 asserted that DOE had overstated the number of 
+weapons scientists receiving support from this program by counting both weapons and non-
+weapons scientists in its totals and that it had overstated the number of long-term private sector 
+
+ 
+
+99 U.S. Department of Energy. FY2004 Congressional Budget Request. Detailed Budget Justifications. February 2003. 
+p. 663. 
+100 U.S. Government Accountability Office, Nuclear Nonproliferation: Concerns With DOE’s Efforts to Reduce the 
+Risks Posed by Russia’s Unemployed Weapons Scientists, GAO Report RCED-99-54, February 19, 1999; U.S. 
+Government Accountability Office. DOE’s Program to Assist Weapons Scientists in the Russia and Other Countries 
+needs to be Reassessed. GAO-08-189, December 2007. 
+
+ Congressional Research Service 
+
+ 45 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+jobs created as a result of this program. Further, DOE did not have an exit strategy for the 
+program, or a way to “graduate” institutes once they were self-sustaining or no longer posed a 
+proliferation threat.101 Partially as a result of these criticisms, the program was reorganized, 
+projects with commercialization potential were given greater priority, work in Russia over time 
+became channeled primarily through the ISTC, and the program was broadened to a global level. 
+
+The Nuclear Cities Initiative (NCI), which began in 1999, was designed to bring commercial 
+enterprises to Russia’s closed nuclear cities, so that Russia could reduce the size of its weapons 
+complex and scientists and engineers would not be tempted to sell their knowledge to nations 
+seeking nuclear weapons. Throughout its brief history, Administration officials, Members of 
+Congress, and others raised questions about the value and effectiveness of the NCI program. The 
+program reportedly made limited progress in addressing the employment problems at Russia’s 
+closed nuclear cities. The NCI program received a total of nearly $87 million between FY1999 
+and FY2003, before it was absorbed into the Russian Transition Initiative. 
+
+ Russian Transition Initiatives (RTI), Global Initiatives for Proliferation 
+Prevention (GIPP) and the Global Security for Science Engagement (GSSP) 
+Programs 
+
+These programs were renamed the Russian Transition Initiatives—to reflect emphasis on 
+commercial partnerships—and Global Initiatives for Proliferation Prevention—to reflect 
+partnership with states outside the former Soviet Union—and then changed to the Global Security 
+for Science Engagement (GSSP) program to reflect partnerships with civilian institutions The 
+Bush Administration requested around $40 million per year for the RTI/GIPP program between in 
+FY2005 and FY2006. In FY2006, the Bush Administration indicated that it planned to phase out 
+the last of the NCI programs in Russia’s closed cities. 
+
+The funding levels for the GIPP/GSSP programs have declined in recent years, from a level of 
+around $40 million per year during the last years of the Bush Administration, to around $20 
+million per year at the beginning of the Obama Administration, to around $15 million per year in 
+recent years. The Administration requested $13 million for FY2014, but no funds were 
+appropriated. This decline has occurred as DOE has begun to shift resources from this program to 
+nations outside the former Soviet Union. As some experts have noted, “the dramatically changed 
+Russian economy creates a very different threat environment; for many former weapons 
+scientists, the risk of desperation-driven proliferation that motivated the U.S. government to 
+establish these programs is much less than it was before.”102 
+
+At the same time, concerns have grown about scientists in other nations. In a review conducted in 
+2010, the Department of Energy determined the “WMD expertise proliferation threat” is not 
+limited to the former Soviet Union or to scientists who were directly involved in weapons 
+programs. As a result, in FY2013, DOE changed the name of the program to Global Security for 
+Science Engagement (GSSP) and initiated a new a global effort, using a new model, to address 
+the expertise proliferation threat. With this change, the program has increased its level of activity 
+in non-Russian states of the former Soviet Union and continued activities in Iraq. DOE plans to 
+
+ 
+ 
+102 Matthew Bunn, Securing the Bomb, 2008 , Nuclear Threat Initiative, Washington, D.C., November 2008, p. 121, 
+http://www.nti.org/media/pdfs/Securing_The_Bomb_2008.pdf?_=1317161155. 
+
+ Congressional Research Service 
+
+ 46 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+engage these countries to build partnerships and share “collective responsibility for scientific best 
+practices.”103 
+
+In Iraq, GIPP/GSSP worked to engage “former WMD scientists, technicians and engineers ... on 
+R&D projects to support global priorities including national security, energy efficiency, and the 
+advancement of medical science.” The program has engaged over 200 Iraqi scientists and 
+engineers (60% of them were former WMD) in more than 30 R&D projects in areas such as 
+public health, environment and water, food safety, and material science. The program expended 
+approximately $7 million to engage Iraq scientists between FY2006 and FY2012. 
+
+The DOE FY2014 funding request asked for $13 million for the GSSP program. Congress did not 
+appropriate any funds for this program in FY2014, and no funding was requested for FY2015. 
+The NNSA FY015 budget request says that Global Security through Science Partnerships (GSSP) 
+program was not established, but the “knowledge security curriculum and approaches developed 
+for GSSP” will be incorporated into other existing programs. 
+
+ 
+
+103 Department of Energy, FY2014 Budget Request , Washington, D.C., April 2013, pp. DN-65, http://energy.gov/sites/
+prod/files/2013/04/f0/Volume1.pdf. 
+
+ Congressional Research Service 
+
+ 47 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Appendix A. Funding Requests, by Agency 
+
+ Table A-1. Department of Defense Cooperative Threat Reduction Program 
+
+($ millions) 
+
+ FY2014 
+
+ FY2015 
+
+ Program FY2012 
+
+ FY2013 
+
+ 
+
+ Estimate 
+
+ Request 
+
+Strategic Offensive Arms 
+
+$28.2 $14.8 $5.7 
+
+$1.0 
+
+Elimination 
+
+Chemical Weapons Destruction 
+
+$9.8 
+
+$69 
+
+$83 
+
+$15.7 
+
+Global Nuclear Security 
+
+$151.1 
+
+$39.3 
+
+$19.4 
+
+$20.7 
+
+Cooperative Biological Engagement 
+
+$229.5 
+
+$211 
+
+$260 
+
+$256.8 
+
+Proliferation Prevention 
+
+$63.1 
+
+$87.3 
+
+$110.4 
+
+$40.7 
+
+Threat Reduction Engagement 
+
+$2.5 
+
+$2.8 
+
+$1.5 
+
+$2.4 
+
+Other Assessments/Administrative 
+
+$24.0 $22 $20.4 $27.8 
+
+Support 
+
+Total $508.2 
+
+$519.1 
+
+$500.5 
+
+365.1 
+
+ 
+
+ Table A-2. Department of State Programs 
+
+($ millions) 
+
+ FY2013 
+
+ FY2013 
+
+ FY2014 
+
+ FY2014 
+
+ FY2015 
+
+ Program FY2012 
+
+ Request 
+
+ Actual 
+
+ Request 
+
+ Estimate 
+
+ Request 
+
+Nonproliferation and Disarmament 
+
+$30.0 $30.0 $27 $25.0 $30.0 $25.0 
+
+Fund 
+
+Export Control and Border 
+
+$61.0 $55.0 $55.6 $54.0 $64.0 $56.7 
+
+Related Security (EXBS) 
+
+Global Threat Reduction 
+
+$69.0 
+
+$63.6 
+
+$64.5 
+
+$63.5 
+
+$77.4 
+
+$65.1 
+
+Weapons of Mass Destruction 
+
+$5.0 $5.0 $5.5 $5.0 $5.0 $4.8 
+
+Terrorism (includes Nuclear 
+Smuggling Outreach Initiative) 
+
+Total $165.0 
+
+$153.6 
+
+$165.9 
+
+$147.5 
+
+$176.4 
+
+$151.6 
+
+ 
+
+ Congressional Research Service 
+
+ 48 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Table A-3. Department of Energy Defense Nuclear Nonproliferation Programs 
+
+($ millions) 
+
+ FY2013 
+
+ FY2013 
+
+ Annualized 
+
+ FY2015 
+
+ Program FY2012 
+
+ Request 
+
+ CR FY2014 
+
+ Request 
+
+International Nuclear Materials Protection and Cooperation 
+
+ 
+
+ 
+
+ 
+
+Navy Complex 
+
+$33.7 
+
+$39.9 
+
+$33.7 
+
+na 
+
+na 
+
+Strategic Rocket Forces/12th Main 
+
+$59.1 $8.3 
+
+$59.1 
+
+na 
+
+na 
+
+Directorate 
+
+Nuclear Warhead Protection 
+
+na 
+
+na 
+
+na 
+
+$23.2 
+
+$0 
+
+Weapons Material Protrection 
+
+$80.7 
+
+$47.0 
+
+$81.2 
+
+$36.4 
+
+$17.1 
+
+Civilian Nuclear Sites 
+
+$59.1 
+
+$60.1 
+
+$59.5 
+
+na 
+
+na 
+
+Material Consolidation and Conversion 
+
+$14.3 
+
+$17.0 
+
+$14.4 
+
+na 
+
+na 
+
+Material Consolidation and Civilian Sites 
+
+na 
+
+na 
+
+na 
+
+$132.3 
+
+$138.6 
+
+National Infrastructure and Sustainability 
+
+$60.9 
+
+$46.2 
+
+$61.3 
+
+$37.8 
+
+$32.3 
+
+Second Line of Defense 
+
+$262.1 
+
+$92.6 
+
+$263.8 
+
+$190.0 
+
+$117.7 
+
+INMPC Total 
+
+$569.9 
+
+$311.1 
+
+$573.0 
+
+$419.7 
+
+$305.5 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+Global Threat Reduction Initiative 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+HEU Reactor Conversion 
+
+$139.5 
+
+$161.0 
+
+$148.3 
+
+$162.0 
+
+$122.4 
+
+Nuclear and Radiological Material Removal 
+
+$221.1 
+
+$200.0 
+
+$200.0 
+
+na 
+
+$101.8 
+
+Nuclear and Radiological Material 
+
+$137.4 $105.0 
+
+$140.1 
+
+na 
+
+$109.3 
+
+Protection 
+
+International Nuclear and Radiological 
+
+na na 
+
+na $200.1 
+
+na 
+
+Material Removal and Protection 
+
+Domestic Radiological Material Removal 
+
+ 
+
+ $80 
+
+na 
+
+and Protection 
+
+GTRI Total 
+
+$498.0 
+
+$466.0 
+
+$488.4 
+
+$424.5 
+
+$333.5 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+Global Inititiatives for Proliferation Prevention/ 
+
+$14.9 $15.1 
+
+$15.1 
+
+$0 
+
+$0 
+
+Global Security Through Science Partnerships 
+
+ 
+
+ Table A-4. Department of Homeland Security Programs 
+
+($millions) 
+
+ FY2014 
+
+ FY2015 
+
+ Program FY2012 
+
+ FY2013 
+
+ 
+
+ FY2014 
+
+ Request 
+
+ Enacted 
+
+ Request 
+
+International Cargo Screening (CSI) 
+
+$81.3 
+
+$70.4 
+
+$72.3 
+
+$67.5 
+
+$69.2 
+
+ 
+
+ Congressional Research Service 
+
+ 49 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Appendix B. Major Provisions in Cooperative 
+Threat Reduction Legislation 
+
+ Table B-1. Title XIII, National Defense Authorization Acts FY2001-FY2013 
+
+ Category (Authorization, 
+
+ Public Law 
+
+ Title XIII 
+
+ Limitation, Waiver, 
+
+ Year 
+
+ No. 
+
+ Section 
+
+ Notable Provisions 
+
+ Reporting, Study) 
+
+FY2001 P.L. 
+
+106-398
+
+1308 
+
+Annual reporting 
+
+Reporting 
+
+requirements 
+
+FY2004 
+
+P.L. 108-136
+
+1304 
+
+Limitation on BW Defense 
+
+Limitation, Reporting 
+
+joint research until Secretary 
+of Defense certifies facility not 
+used for BW development and 
+site is secure 
+
+ 
+
+ 
+
+1306 
+
+Temporary authority to waive 
+
+Waiver
+
+CWD funding limitation 
+
+ 
+
+1308 
+
+Authority to use CTR funds 
+
+Authorization 
+
+outside the former Soviet 
+Union in response to emerging 
+threats and not to exceed $50 
+million 
+
+FY2005 
+
+P.L. 108-375
+
+1303 
+
+Extension of CWD funding 
+
+Waiver
+
+waiver authority 
+
+FY2006 
+
+P.L. 109-163
+
+1303 
+
+Permanent Waiver of 
+
+Waiver
+
+restrictions on use of funds in 
+the FSU 
+
+ 
+
+ 
+
+1304 
+
+Report on impediments to 
+
+Reporting 
+
+CTR required 
+
+FY2007 
+
+P.L. 109-364
+
+1303 
+
+Extension of CWD funding 
+
+Waiver
+
+waiver authority 
+
+ 
+
+ 
+
+1304 
+
+NAS Study commissioned
+
+Study
+
+FY2008 
+
+P.L. 110-181
+
+1303 
+
+Specification of use of funds 
+
+Authorization 
+
+for programs outside the FSU 
+
+ 
+
+ 
+
+1304 
+
+Repeal of restrictions on 
+
+Repeal of limitations and waivers
+
+assistance to states of the 
+former Soviet Union for 
+Cooperative Threat Reduction 
+
+ 
+
+1305 
+
+Authorization for use of funds 
+
+Authorization 
+
+outside the FSU (removal of 
+funding limit), Secretary of 
+Defense determination with 
+concurrence of Secretary of 
+State 
+
+ Congressional Research Service 
+
+ 50 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Category (Authorization, 
+
+ Public Law 
+
+ Title XIII 
+
+ Limitation, Waiver, 
+
+ Year 
+
+ No. 
+
+ Section 
+
+ Notable Provisions 
+
+ Reporting, Study) 
+
+ 
+
+ 
+
+1306 
+
+Sense of Congress on new 
+
+Study, Reporting 
+
+initiatives for CTR: continue 
+work in Russia and the FSU; 
+expand to Asia and the Middle 
+East, DPRK; NAS study; 
+Secretary of Defense report 
+on new CTR initiatives 
+
+ 
+
+ 
+
+1307 
+
+Reporting requirement on 
+
+Reporting 
+
+Shchuch’ye, Russia CWD 
+facility 
+
+ 
+
+ 
+
+1308 
+
+NAS Study on Prevention of 
+
+Study
+
+Proliferation of Biological 
+Weapons 
+
+FY2010 
+
+P.L. 111-84 
+
+1303 
+
+Terms for accepting 
+
+Authorization 
+
+contributions to CTR 
+programs from foreign 
+government, international 
+organizations or any entity 
+
+ 
+
+ 
+
+1304 
+
+Report on CTR Metrics by 
+
+Reporting, Study 
+
+Secretary of Defense and NAS 
+
+ 
+
+ 
+
+1305 
+
+CTR Authority for urgent 
+
+Authorization 
+
+threat reduction activities: 
+determination by Secretaries 
+of Defense and State; 
+notification to Congress 
+
+FY2011 
+
+P.L. 111-383
+
+1303 
+
+Limitation on use of FY11 
+
+Limitation, Reporting 
+
+CTR funds for Centers of 
+Excel ence in non-FSU 
+countries—not more than 
+$500,000 until report to 
+Congress on purpose, funding 
+plan for center 
+
+ 
+
+ 
+
+1304 
+
+Secretaries of Defense and 
+
+Reporting 
+
+Energy joint plan on 
+nonproliferation and CTR 
+activities with the P.R. China 
+FY11-16 
+
+FY2012 
+
+P.L. 112-81 
+
+1303 
+
+Limitation on Availability of 
+
+Limitation, Reporting 
+
+Funds for Cooperative 
+Biological Engagement 
+Program to 80% of 
+appropriation until 
+certifications sent to Congress 
+
+ 
+
+ 
+
+1304 
+
+Limitation on use of FY12 
+
+Limitation , Reporting (extension 
+
+CTR funds for Centers of 
+
+of FY2011, §1303) 
+
+Excel ence in non-FSU 
+countries—not more than 
+$500,000 until report to 
+Congress on purpose, funding 
+plan for center 
+
+FY2013 
+
+P.L. 112-239
+
+1303 
+
+Report on CTR programs in 
+
+Reporting 
+
+Russia by Secretary of Defense 
+with State, Energy, DNI 
+
+ Congressional Research Service 
+
+ 51 
+
+ 
+ The Evolution of Cooperative Threat Reduction: Issues for Congress 
+
+ 
+
+ Category (Authorization, 
+
+ Public Law 
+
+ Title XIII 
+
+ Limitation, Waiver, 
+
+ Year 
+
+ No. 
+
+ Section 
+
+ Notable Provisions 
+
+ Reporting, Study) 
+
+FY2014 
+
+P.L. 113-66 
+
+1302 
+
+Percentage limitations shal 
+
+Authorization 
+
+not apply to FY14 and FY15 
+activities related to Syria 
+
+FY2014 
+
+P.L. 113-66 
+
+1302 
+
+Quarterly briefings to include 
+
+Reporting 
+
+comprehensive assessment of 
+Syria chemical weapons 
+stockpile, destruction status 
+and plan; accounting of funds 
+expended 
+
+FY2014 
+
+P.L. 113-66 
+
+1303 
+
+FY10 authority for urgent 
+
+Authorization 
+
+threat reduction activities 
+extended to December 31, 
+2018 
+
+FY2014 
+
+P.L. 113-66 
+
+1304 
+
+Requires development of a 
+
+Reporting 
+
+strategy to modernize CTR 
+and prevent WMD 
+proliferation in the Middle East 
+and North Africa to be 
+submitted by March 31, 2014 
+
+ Source: CRS compilation. 
+
+ 
+
+ Author Contact Information 
+ 
+Mary Beth D. Nikitin 
+
+ Amy F. Woolf 
+
+Specialist in Nonproliferation 
+
+Specialist in Nuclear Weapons Policy 
+
+mnikitin@crs.loc.gov, 7-7745 
+
+awoolf@crs.loc.gov, 7-2379 
+
+ 
+ 
+
+ Congressional Research Service 
+
+ 52
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--- /dev/null
+++ b/corpus/politics/text/0620ff56d908c3fb.txt
@@ -0,0 +1,226 @@
+National Infrastructure Bank: Proposals in the 119 th Congress
+
+ 
+
+ September 2, 2026
+ (IF13304)
+ 
+
+ 
+ Introduction
+
+ The term infrastructure generally refers to long-lived, capital-intensive systems and facilities in the areas of transportation, energy, water, and telecommunications. Some broader definitions also include facilities for education, recreation, and health. The condition and performance of these systems are generally thought to be important for the nation's well-being, but there is less agreement on the optimal level of infrastructure investment, how to maximize the effectiveness of spending, and the appropriate role of the federal government in the development of infrastructure and its operations and maintenance (O&M).
+
+ State and local governments and the private sector provide the bulk of infrastructure investment in the United States. The federal role in infrastructure investment is limited in size and scope. In 2023, the federal government was responsible for 31% of government capital spending on transportation and water infrastructure and 13% of O&M spending. The federal government supports infrastructure investment in four ways: (1) direct investment in federally owned infrastructure; (2) grants to nonfederal entities, especially state and local governments; (3) tax preferences that forgo federal revenue to provide incentives for nonfederal investment in infrastructure; and (4) loans and other types of credit assistance to nonfederal entities.
+
+ National Infrastructure Bank
+
+ A national infrastructure bank is typically seen as a way for the federal government to provide loans, loan guarantees, and lines of credit to support infrastructure projects carried out by nonfederal entities. Many different formulations have been proposed over the years, but policy choices typically include
+
+ Infrastructure type. Some proposals focus on one type, such as transportation or energy, but most would support a wider spectrum of sectors.
+
+ Institutional form and governance. Most current proposals would create a wholly owned government corporation overseen by a board whose members are selected by the President or Congress. Other models would place the bank inside an existing federal agency and create a government-sponsored enterprise with an independent board.
+
+ Funding source. Many legislative proposals would create an entity supported by an appropriation that would leverage a larger amount to loan from the U.S. Treasury. These national infrastructure banks would provide credit assistance under the terms of the Federal Credit Reform Act of 1990 (FCRA; 2 U.S.C. § § 661 - 661 f ) and would be possibly supported by an appropriation to pay the subsidy and administrative costs. According to FCRA, the subsidy cost is "the estimated long-term cost to the Government of a direct loan or a loan guarantee ... calculated on a net present value basis." Assuming a 10% subsidy cost, every $1 appropriated for purposes other than administrative costs would enable the bank to lend $10 to projects. Loan repayments would go to the U.S. Treasury, not the bank. Other legislative proposals would create a national infrastructure bank as a revolving fund. This would limit credit assistance to the funds made directly available, but borrower repayments could be used to make new loans. In some revolving fund formulations, an infrastructure bank would raise its own capital through the issuance of stock or bonds.
+
+ Advantages and Disadvantages
+
+ Advantages of a national infrastructure bank potentially include the leveraging of state, local, and private-sector investment; data-driven project selection; and highly skilled staff with expertise in infrastructure financing. If a bank issues its own securities that are not tax exempt, it could tap pools of private capital—such as pension funds and foreign citizens—that for tax and other reasons do not invest in tax-exempt bonds, the traditional sources of project finance. 
+
+ Drawbacks of a national infrastructure bank might include the limited number of suitable projects for support and pressure to allocate loans according to political criteria. In some formulations, a national infrastructure bank exposes the federal government to the risk of default. Another possible drawback is duplication of existing federal infrastructure credit assistance programs, including 
+ the Department of Transportation's (DOT's) Transportation Infrastructure Finance and Innovation Act ,
+
+ DOT's Railroad Rehabilitation and Improvement Financing ,
+
+ the Environmental Protection Agency's Water Infrastructure Finance and Innovation Act ,
+
+ the Army Corps of Engineers' Water Infrastructure Financing Program , and
+
+ the Department of Energy's Energy Dominance Financing Program .
+ A national infrastructure bank may not be the lowest-cost means of increasing infrastructure spending. The Congressional Budget Office has noted that a special entity issuing its own debt would not be able to offer the low interest and issuance costs of the U.S. Treasury. Some see a larger federal role in infrastructure financing as a drawback and suggest that Congress might enhance the operation of state infrastructure banks (SIBs) as an alternative. This might involve dedicated federal funding to capitalize SIBs.
+
+ Legislative Proposals in the 119 th Congress
+
+ Legislative proposals for a national infrastructure bank date back to at least 1983 ( S. 532 , 98 th Congress), and many related bills have been introduced since then. No proposal has been enacted on its own or as part of broader legislation. National infrastructure bank bills introduced in the 119 th Congress include the Federal Infrastructure Bank Act of 2025 ( H.R. 1235 ), the National Infrastructure Investment Corporation Act of 2025 ( H.R. 4315 ), and the National Infrastructure Bank Act of 2025 ( H.R. 5356 ). See Table 1 for details of these three bills. 
+
+ The National Infrastructure Investment Corporation Act of 2025 ( H.R. 4315 ), for example, would create a wholly owned government corporation, governed by a seven-member board of directors. Three of these directors would be appointed by the President with advice and consent of the Senate, and four would be appointed by congressional leaders. The corporation would be authorized to provide loans and loan guarantees to infrastructure project sponsors, including those in the transportation, energy, environmental, and telecommunications sectors. The corporation would be authorized to accept loans from pension funds rather than receive an appropriation. 
+
+ Proposals relating to a national infrastructure bank may be considered in surface transportation reauthorization legislation. In May 2026, a reauthorization bill ( H.R. 8870 )—the Building Unrivaled Infrastructure and Long-term Development for America's 250 th Act (BUILD America 250 Act)—was introduced in the House of Representatives, marked up in committee, and ordered to be reported. Section 2004 of the bill would require the Secretary of Transportation to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine to send Congress a report within two years of enactment "on the establishment of a Federal Infrastructure Bank to facilitate investment in, and the long-term financing of, economically viable United States infrastructure projects that provide a public benefit, including best practices for implementing such bank."
+
+ According to Section 2004 of H.R. 8870 , as ordered to be reported, some of the subjects the infrastructure bank study would be required to investigate include equity investment by the bank; the effects on overall infrastructure investment; how such an entity could complement existing federal credit assistance programs; opportunities to finance nonrevenue infrastructure projects and projects located in rural and economically disadvantaged areas; effects on the lending capacity of existing state infrastructure banks; and best practices of national infrastructure banks in other countries and SIBs.
+
+ 
+
+ 
+ 
+ Table 1. Infrastructure Bank Bills in 119 th Congress
+
+ 
+ 
+ 
+
+ 
+ 
+ H.R. 5356 
+
+ 
+ 
+ H.R. 1235 
+
+ 
+ 
+ H.R. 4315 
+
+ 
+ 
+ 
+ 
+ B ill Title 
+
+ 
+ 
+ National Infrastructure Bank Act of 2025
+
+ 
+ 
+ Federal Infrastructure Bank Act of 2025
+
+ 
+ 
+ National Infrastructure Investment Corporation Act of 2025
+
+ 
+ 
+ 
+ 
+ Proposed E ntity 
+
+ 
+ 
+ National Infrastructure Bank
+
+ 
+ 
+ Federal Infrastructure Bank
+
+ 
+ 
+ National Infrastructure Investment Corporation
+
+ 
+ 
+ 
+ 
+ Organization T ype 
+
+ 
+ 
+ Mixed-ownership government corporation
+
+ 
+ 
+ Government-Sponsored Enterprise
+
+ 
+ 
+ Wholly owned government corporation
+
+ 
+ 
+ 
+ 
+ Governance 
+
+ 
+ 
+ Twenty-five-member board of directors appointed by President with advice and consent of Senate
+
+ 
+ 
+ Seven-member board elected by shareholders
+
+ 
+ 
+ Seven-member board of directors; three appointed by President with advice and consent of Senate; four appointed by congressional leaders
+
+ 
+ 
+ 
+ 
+ Eligible I nfrastructure P rojects 
+
+ 
+ 
+ Transportation, energy, environmental, a telecommunications, affordable housing, school, public recreation, library, worker training facility
+
+ 
+ 
+ Transportation, energy, water, other infrastructure identified by the bank
+
+ 
+ 
+ Transportation, energy, environmental, telecommunications
+
+ 
+ 
+ 
+ 
+ Types of C redit A ssistance 
+
+ 
+ 
+ Direct loans, loan guarantees, credit insurance
+
+ 
+ 
+ Equity investments, direct loans, indirect loans, and loan guarantees
+
+ 
+ 
+ Direct loans, loan guarantees 
+
+ 
+ 
+ 
+ 
+ Funding 
+
+ 
+ 
+ Sale of capital stock, callable capital; may issue own bonds, bank deposits, fees, $100 million appropriation for start-up costs
+
+ 
+ 
+ Sale of capital stock; may issue own bonds
+
+ 
+ 
+ Loans from pension funds
+
+ 
+ 
+ 
+ 
+ B ank Type 
+
+ 
+ 
+ Revolving fund
+
+ 
+ 
+ Revolving fund
+
+ 
+ 
+ Revolving fund
+
+ 
+ 
+ 
+ 
+ Source: Congressional Research Service from bills in the 119 th Congress: H.R. 1235 (as introduced), H.R. 4315 (as introduced), and H.R. 5356 (as introduced).
+
+ Note: 
+
+ a. "Environmental" includes drinking water and wastewater treatment facilities, stormwater management systems, open-space management systems, wetland restoration, solid waste disposal facilities, hazardous waste facilities, and industrial site cleanup projects.
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+++ b/corpus/politics/text/0830ebe28d6d3cdf.txt
@@ -0,0 +1,20 @@
+Public Expenditure and Financial Accountability Assessment
+
+The objective of the Public Expenditure
+            and Financial Accountability (PEFA) assessments is to review
+            the current performance of the public financial management
+            (PFM) systems, processes, and institutions of the Federal
+            Government of Ethiopia. The assessment aims to assist the
+            government in identifying PFM weaknesses that may inhibit
+            effective delivery of services to its citizens and the
+            realization of its development objectives in general.
+            Furthermore, the findings of the PEFA assessment will assist
+            the government in refining the PFM reform strategy that it
+            has already developed and provide the basis for a coherent
+            PFM reform program that can be supported by development
+            partners, as well as through the government’s own
+            initiatives. The Federal PEFA assessment covered federal
+            government budgeted units, extra-budgetary units (EBUs), the
+            Office of the Federal Auditor General (OFAG), and
+            Parliament, The assessment management framework, oversight,
+            and quality assurance are summarized in this report.
\ No newline at end of file
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index 0000000000000000000000000000000000000000..066b19ac47ad0c2bab6322072f32c54b4a6da6dd
--- /dev/null
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+August 1, 2018
+
+ Iran’s Ballistic Missile and Space Launch Programs
+Overview 
+
+The Fateh-110 is a solid-fuel, road-mobile battlefield or 
+
+Iran has been acquiring, developing, and testing its ballistic 
+
+tactical ballistic missile with a range of about 250-300 km. 
+
+missile capabilities for decades. The United Nations 
+
+There may be four versions of the Fateh-110 in service; one 
+
+Security Council in 2015 adopted resolution 2231, calling 
+
+is apparently called the Khalij-Fars (“Persian Gulf”). 
+
+on, but not requiring, Iran to not develop nuclear-capable 
+ballistic missiles and to halt other ballistic missile activity. 
+
+ Medium-Range Ballistic Missiles 
+
+Nevertheless, Iran continues to invest in developing 
+
+ (MRBMs) 
+
+ballistic missiles and in building an extensive network of 
+
+Iran is developing and producing MRBM capabilities with 
+
+facilities, although missile inventory information is scarce. 
+
+ranges estimated up to about 2,000 kilometers (some non-
+U.S. government sources cite slightly higher ranges), 
+
+Iran’s short- and medium-range ballistic missile tests 
+
+sufficient to strike targets throughout the Middle East. 
+
+indicate that Iran is focused on increasing the accuracy of 
+its missiles. Once forecasted to have an intercontinental-
+
+According to the National Air and Space Intelligence 
+
+range ballistic missile before now, Iran has not yet 
+
+Center (NASIC) in 2017, Iran has perhaps fewer than 50 
+
+demonstrated this capacity. Furthermore, Iran’s space 
+
+MRBM launchers and an unknown number of associated 
+
+launch program continues to experience significant delays, 
+
+missiles. Iran continues to develop, test, and build more 
+
+and may be slowing. 
+
+capable and increasingly accurate MRBMs. Iran argues 
+these missiles constitute an important deterrent and 
+
+ Short-Range Ballistic Missiles (SRBMs) 
+
+retaliatory force against U.S. and other forces in the region 
+
+The majority of Iran’s heavy artillery rockets and ballistic 
+
+in the event of war. Iran has also constructed an 
+
+missiles are tactical or short-range (less than 500 
+
+underground network of bunkers and silo-like missile 
+
+kilometers). Most of Iran’s ballistic missiles are Scud-B and 
+
+launch facilities, and is seeking improved air defenses, 
+
+Scud-C derivatives, with a majority likely being Scud-Cs. 
+
+presumably to enhance the survivability of their MRBMs 
+
+Iran has less than 100 SRBM reusable transporter-erector-
+
+against preemptive attack. 
+
+launchers (TELs) and likely has hundreds of SRBMs. 
+
+Like the SRBM program, Iran relies to some extent on 
+
+Iran views its SRBM capability as necessary for battlefield 
+
+others, particularly North Korea, for certain key missile 
+
+and tactical military purposes. Iran often test-fires these 
+
+components and materials in its MRBM program. Export 
+
+missiles as part of its military exercises. Iran’s SRBMs 
+
+controls and sanctions have made it increasingly difficult, 
+
+could strike U.S. and allied bases in the Gulf region if 
+
+but not impossible, for Iran to acquire the best of such 
+
+moved from their operating bases, as well as targets 
+
+items, causing Iran to try to exploit weaknesses in existing 
+
+throughout Iraq, but they could not reach Israel. 
+
+export and nonproliferation regimes, or to try to find 
+foreign sellers willing to circumvent those laws. 
+
+Iran has grown increasingly self-sufficient in producing 
+SRBMs, but still probably relies on outside sources, such as 
+
+ Shahab-3, Ghadr-1/Emad, and Sajil/Ashura 
+
+North Korea, for some key components and materiel. 
+
+The Shahab-3 is a ballistic missile imported from the 
+
+Stricter international enforcement of export controls and 
+
+DPRK and based on the No-dong 1. The Shahab-3 has been 
+
+broadening missile-related sanctions—which remain in 
+
+given various names by Iran and others over time. There 
+
+place under the Iran nuclear agreement—have reportedly 
+
+reportedly have been several different versions of this 
+
+slowed Iran’s efforts. 
+
+liquid-fueled missile flight tested with various other 
+modifications made to it, perhaps providing the Shahab-3 
+
+ Shahab-1/2, Qiam, and Fateh-110 
+
+with ranges varying from about 800-1,000 km. The missile 
+
+The Qiam ballistic missile was first tested in August 2010, 
+
+is reportedly both road-mobile and silo-based. 
+
+and continues to be operational. UN Reports and U.S. 
+government reports released in recent years have 
+
+Because the range of the Shahab-3 lies at the low end of an 
+
+highlighted escalations in both its use by Iran and transfer 
+
+MRBM, Iran has sought to develop, test, and deploy a 
+
+to regional forces allied with Iran. The Qiam was launched 
+
+much longer-range ballistic missile. Iran’s first efforts in 
+
+from Iran targeting ISIL fighters in Syria in June 2017, and 
+
+extending the range of the Shahab-3 manifested in what 
+
+modified versions of the SRBM have also been used in 
+
+some have variously referred to as the Ghadr-1. The 
+
+Yemen on several occasions in 2018. The Qiam rocket is 
+
+Shahab-3 variant is road-mobile, liquid-fueled, and single-
+
+road-mobile, liquid-fueled, and finless, and it is capable of 
+
+stage, and it is believed by some experts to carry a smaller 
+
+achieving a range of 800 km. 
+
+payload and a modified reentry vehicle (RV). Modified 
+Ghadr MRBMs were reportedly tested in March 2016. The 
+Emad, which began being publicized in 2015 as a longer-
+
+https://crsreports.congress.gov 
+
+ 
+ 
+
+Iran’s Ballistic Missile and Space Launch Programs 
+
+range MRBM, appears to be a Ghadr variant with a 
+
+low-earth orbit and as such is not considered to be capable 
+
+modified RV. 
+
+of providing a long-range nuclear weapons capability. The 
+Safir-1B is the second-generation Safir SLV capable of 
+
+The Sajil (also transliterated Sejil/Sejjil) is a solid-fueled, 
+
+putting a 60 kilogram payload into low-earth orbit. 
+
+two-stage, ground-mobile ballistic missile that Iran says has 
+a range of about 2,000 km, according to official U.S. 
+
+A more powerful rocket was displayed as a mockup in 2010 
+
+sources. This MRBM was first announced under the name 
+
+and named the Simorgh, which is designed to carry heavier 
+
+Ashura in November 2007, but either the missile or the 
+
+satellites into orbit using four main engines. Having 
+
+solid propellant motor tested unsuccessfully at the time. 
+
+postponed its first launch for several years, the design may 
+
+Subsequently renamed the Sajil, it was flight tested 
+
+have undergone various modifications. Iranian state media 
+
+successfully in November 2008. Additional tests of the Sajil 
+
+claimed on July 27, 2017, that a Simorgh launched from the 
+
+or a modified and apparently more capable version of it, the 
+
+Imam Khomeini Space Center, a newly built space complex 
+
+Sajil-2, took place in May, September, and December 2009. 
+
+in southeastern Iran, placed a 250 kilogram satellite into 
+
+The Sajil-2 has since highlighted significant progress in 
+
+low-earth orbit. Some U.S. media reports at the time 
+
+Iran’s solid-propellant program, which could afford Iran’s 
+
+indicated the Simorgh exploded shortly after launch and 
+
+missiles reduced response time and risk of detection. 
+
+there is no evidence it achieved orbit. 
+
+ Figure 1.MRBM Sites and Ranges 
+
+ Space Launch and Long-Range Missiles 
+ Some have long believed Iran’s space launch program 
+could mask the development of an intercontinental ballistic 
+missile (ICBM) with ranges in excess of 5,500 km that 
+could threaten targets throughout Europe, and even the 
+United States (at least 10,000 km). According to the 
+intelligence community (IC) in 2018, “Tehran’s desire to 
+deter the United States might drive it to field an ICBM. 
+
+Progress on Iran’s space program, such as the launch of the 
+Simorgh SLV in July 2017, could shorten a pathway to an 
+ICBM because space launch vehicles use similar 
+technologies.” 
+
+ICBMs share many similar technologies and processes 
+inherent in a space launch program, but many years ago 
+Iran outlined a long-term dedicated space launch effort (that 
+has since slowed considerably) that is not simply a cover 
+for ICBM development. In addition, no country has 
+developed an ICBM from its space launch technology base; 
+space launch programs have generally developed from 
+military ballistic missile programs. 
+
+ In 1999, the IC first assessed that Iran could test an ICBM 
+
+ Source: CRS. 
+
+by 2015 if it received sufficient foreign assistance, 
+
+ Space Launch Program 
+
+especially from a country such as China or Russia (whose 
+
+Iran has an ambitious space launch and satellite program, 
+
+support reportedly subsequently diminished in the 2000s). 
+
+CRS assessed in 2012 that it was “increasingly uncertain 
+
+which seeks to enhance its national pride and, perhaps more 
+importantly, its international reputation as a growing 
+
+whether Iran will be able to achieve an ICBM capability by 
+
+advanced industrial power. Iran also views itself as a 
+
+2015 for several reasons: Iran does not appear to be 
+receiving the degree of foreign support many believe would 
+
+potential leader in the Middle East offering space launch 
+and satellite services. Iran has stated that it plans to use 
+
+be necessary; Iran has found it increasingly difficult to 
+
+future launches for placing intelligence-gathering satellites 
+
+acquire certain critical components and materials because 
+of sanctions; and Iran has not demonstrated the kind of 
+
+into orbit, although proliferation experts assess such a 
+
+flight test program many view as necessary to produce an 
+
+capability is likely a decade or so in the future. 
+
+ICBM.” Those assessments remain valid. 
+
+ Space Launch Vehicles (SLVs) 
+ Iran currently operates two types of SLVs: the Safir 
+
+Although not representing the IC, Adm. Gortney (Northern 
+
+(“Envoy”) and the Simorgh (“Phoenix”). Iran’s SLVs are 
+
+Command) seemingly updated the U.S. government 
+assessment, stating on March 10, 2016: “Iran has 
+
+liquid-fueled, two-stage rockets capable of placing a 
+
+successfully orbited satellites using its ICBM-class booster 
+
+payload into low-earth orbit. 
+
+as early as this year. In light of these advances we assess 
+Iran may be able to deploy an operational ICBM by 2020 if 
+
+Iran used the Safir SLV to launch the OMID satellite into 
+
+the regime chooses to do so.”
+
+orbit in February 2008. The Safir SLV used a first stage 
+
+ 
+
+based on the single-stage Shahab-3 with a specially 
+designed second stage. Iran still develops this liquid-fueled 
+
+ Steven A. Hildreth , Specialist in U.S. and Foreign 
+
+SLV. The Safir is designed to carry a light payload into 
+
+National Security Programs 
+
+https://crsreports.congress.gov 
+
+ 
+ Iran’s Ballistic Missile and Space Launch Programs 
+
+ 
+
+ IF10938 
+
+ Cyrus A. Jabbari , Research Associate 
+ 
+
+ 
+
+ Disclaimer 
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to 
+congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. 
+Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has 
+
+been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the 
+United States Government, are not subject to copyright protection in the United States. Any CRS Report may be 
+reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include 
+copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you 
+wish to copy or otherwise use copyrighted material. 
+
+ 
+
+ https://crsreports.congress.gov | IF10938 · VERSION 2 · NEW
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+Order Code RL32370
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ The Coalition Provisional Authority (CPA): 
+
+ Origin, Characteristics, and 
+
+ Institutional Authorities 
+
+ Updated September 21, 2006 
+
+L. Elaine Halchin
+
+Analyst in American National Government
+
+Government and Finance Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ The Coalition Provisional Authority (CPA): 
+
+Origin, Characteristics, and Institutional Authorities 
+
+ Summary 
+
+Responsibility for overseeing reconstruction in post-conflict Iraq initially fell
+
+to the Office of Reconstruction and Humanitarian Assistance (ORHA). Established
+in early 2003, ORHA was headed by Lieutenant General Jay M. Garner, U.S. Army
+(ret.). By June 2003, ORHA had been replaced, or subsumed, by the Coalition
+Provisional Authority (CPA), which was led by Ambassador L. Paul Bremer III. On
+June 28, 2004, CPA ceased operations.
+
+Whether CPA was a federal agency is unclear. Competing, though not
+
+necessarily mutually exclusive, explanations for how it was established contribute to
+the uncertainty about its status. Some executive branch documents supported the
+notion that it was created by the President, possibly as the result of a National
+Security Presidential Directive (NSPD). (This document, if it exists, has not been
+made available to the public.) Another possibility is that the authority was created
+by, or pursuant to, United Nations Security Council Resolution 1483 (2003). Finally,
+two years after CPA was established, a Justice Department brief asserted that the
+then-Commander of U.S. Central Command (CENTCOM) had created CPA. 
+
+Given that its organizational status is uncertain, an examination of selected
+
+features of CPA might be instructive in assessing what type of organization it was.
+The authority was closely aligned with the Department of Defense (DOD); the Under
+Secretary of Defense designated the Secretary of the Army as executive agent for
+CPA. Other significant features of the authority included its Office of Inspector
+General (OIG, or IG), which was expected to work closely with the DOD and U.S.
+Agency for International Development (USAID) Offices of Inspector General; the
+extent of its procurement activities; its regulatory authority; and its Program Review
+Board. An undated organization chart provided some insight into the structure of the
+authority, although it did not include some key offices and positions, such as the
+Deputy Administrator, the OIG, and the legislative affairs staff. Provisions in several
+statutes included reporting requirements that bore directly or indirectly on CPA.
+These included Sections 2202(b), 2203, 2207, and 3001 of P.L. 108-106 (117 Stat.
+1209), and Section 1203 of P.L. 108-136 (117 Stat. 1392).
+
+Subsequent to the dissolution of CPA, the question of its status arose in a
+
+lawsuit filed against Custer Battles, LLC (CB), a company that performed work for
+CPA. Two former employees of CB alleged in a lawsuit filed under the False Claims
+Act (FCA) that the company had defrauded the federal government. (The case is
+ United States ex rel. DRC Inc. v. Custer Battles, LLC (E. Va., No. CV-04-199-A).)
+Justice Department attorneys concluded that CPA was an instrumentality of the U.S.
+government for the purposes of the FCA, but the presiding judge determined, in his
+August 2006 opinion, that CPA was not an instrumentality. This report will be
+updated as events warrant. 
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+The Office of Reconstruction and Humanitarian Assistance and the 
+
+Coalition Provisional Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Key CPA Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+Establishment of CPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+
+National Security Presidential Directive . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+United Nations Security Council Resolution 1483 . . . . . . . . . . . . . . . . . . . . 9
+General Franks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
+
+Selected Characteristics of CPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
+
+CPA’s Relationship to the Department of Defense . . . . . . . . . . . . . . . . . . . 15
+CPA Office of Inspector General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
+Procurement Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+
+Appropriated Funds for the Reconstruction of Iraq . . . . . . . . . . . . . . . 20
+CPA Solicitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
+Program Review Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
+Protests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
+Appropriated Funds for the Operating Expenses of CPA . . . . . . . . . . 28
+
+Regulatory Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
+CPA Organization Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
+
+Statutory Reporting Requirements Concerning CPA and the Reconstruction 
+
+of Iraq . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
+Status and Characteristics of CPA as Related to the False Claims 
+
+Act (FCA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
+
+Discussion of CPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
+
+Post-CPA Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
+
+Iraq Reconstruction Management Office (IRMO) and Project and 
+
+Contracting Office (PCO) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
+
+Office for Reconstruction and Stabilization . . . . . . . . . . . . . . . . . . . . . . . . 45
+
+Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
+
+Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
+
+ List of Figures 
+
+Figure 1. Coalition Provisional Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
+
+ List of Tables 
+
+ Table 1. Statutory Reporting Requirements Concerning the CPA and 
+
+the Reconstruction of Iraq . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
+
+ 
+ The Coalition Provisional Authority (CPA): 
+
+Origin, Characteristics, and 
+
+Institutional Authorities
+
+ Introduction 
+
+The Coalition Provisional Authority (CPA or “the authority”) was established
+
+approximately one month after United States and coalition forces took control of
+Baghdad in Iraq on April 9, 2003.1 The authority’s mission was “to restore
+conditions of security and stability, to create conditions in which the Iraqi people can
+freely determine their own political future, (including by advancing efforts to restore
+and establish national and local institutions for representative governance) and
+facilitating economic recovery, sustainable reconstruction and development.”2
+Information provided on the CPA website indicated that “[t]he Governing Council
+and the Coalition Provisional Authority will be dissolved” by June 30, 2004, and that
+“[t]his will end the responsibilities of the Coalition as an occupying power as
+specified in the United Nations resolutions.”3 
+
+After examining the origin of CPA, this report discusses three views on how the
+
+authority was established, reviews selected characteristics of the authority, identifies
+statutory reporting requirements concerning the authority and the reconstruction of
+Iraq, examines the implications of U.S. v. Custer Battles for CPA, explores several
+policy issues, and briefly describes post-CPA organizations.
+
+ The Office of Reconstruction and Humanitarian 
+
+ Assistance and the Coalition Provisional Authority 
+
+Responsibility for providing humanitarian assistance and aiding in the
+
+reconstruction of postwar Iraq initially fell to the Office of Reconstruction and
+Humanitarian Assistance (ORHA). ORHA was established by National Security
+Presidential Directive (NSPD) 24, which was signed by the President on January 20,
+
+1 CRS Report RL32105, Post-War Iraq: A Table and Chronology of Foreign Contributions ,
+by Jeremy M. Sharp, Melanie Caesar, and Adam Frost, p. 10.
+
+2 U.S. Office of Management and Budget, Report to Congress Pursuant to Section 1506 of
+the Emergency Wartime Supplemental Appropriations Act, 2003 (Public Law 108-11) , June
+2, 2003, p. 2.
+
+3 Coalition Provisional Authority and Iraqi Governing Council, The November 15
+Agreement: Timeline to a Sovereign, Democratic and Secure Iraq , available at
+[http://iraqcoalition.org/government/AgreementNov15.pdf].
+
+ 
+ CRS-2
+
+2003. This document also gave DOD responsibility for post-war control of Iraq.4
+NPSD 24 has not been released to the public. A news article stated that ORHA was
+tied to the Pentagon and that, while the U.S. Agency for International Development
+(USAID) would handle much of the humanitarian and reconstruction work, ORHA
+would be in charge of the funding.5 As early as February 12, it was reported that
+Lieutenant General Jay M. Garner, U.S. Army (ret.), had been selected to serve as the
+coordinator for humanitarian and reconstruction assistance, and that he would report
+to General Tommy R. Franks, then-commander of U.S. Central Command.6
+Lieutenant General Garner was appointed by the Secretary of Defense, and his
+position description as head of ORHA stated:
+
+This Office [ORHA] is established at the direction of the President of the United
+States, and is located for administrative purposes under Boards, Commissions
+and Task Forces, Washington Headquarters Services. This Office is under the
+supervision of the Under Secretary of Defense for Policy.7 
+
+Signed by the Office of the Under Secretary of Defense for Policy on February 11,
+2003, this position description was not approved and certified by the Director,
+Administration and Management, Office of the Secretary of Defense, until March 5,
+2003.8
+
+As late as mid-April, it appeared that Lieutenant General Garner was still in
+
+charge of ORHA.9 However, a news report dated May 2 stated that President George
+W. Bush planned to name Ambassador L. Paul Bremer III as special envoy and civil
+administrator of Iraq, and that Lieutenant General Garner would report to
+Ambassador Bremer.10 On May 6, 2003, President Bush announced that he had
+appointed Ambassador Bremer as Presidential Envoy and that he would serve as the
+senior leader of the coalition. (Unlike his appointment as an ambassador earlier in
+his career, Senate confirmation was neither required nor sought.) The White House
+press release also stated:
+
+4 U.S. Department of Defense, Office of the Inspector General, Contracts Awarded for the
+Coalition Provisional Authority by the Defense Contracting Command-Washington , Report
+D-2004-057, March 18, 2004, p. 1, available at [http://www.dodig.osd.mil/Audit/reports/
+FY04/04057sum.htm].
+
+5 DeYoung and Morgan, “U.S. Plan for Iraq’s Future is Challenged; Pentagon Control,
+Secrecy Questioned,” p. A21.
+
+6 Peter Slevin, “U.S. Military Lays Out Postwar Iraq Plan; Officials Brief Congress on
+Rebuilding Battered Economy, Reshaping Society,” Washington Post , Feb. 12, 2003, p.
+A21. 
+
+7 U.S. Department of Defense, Office of the Inspector General, Contracts Awarded for the
+Coalition Provisional Authority by the Defense Contracting Command-Washington , p. 1.
+
+8 Ibid.
+
+9 Peter Baker, “U.S. Forces Will Redeploy into 3 Zones; Marines to Occupy Southern Iraq
+as Army Takes over North; General Will Oversee Capital,” Washington Post , Apr. 15, 2003,
+p. A31.
+
+10 Mike Allen, “Expert on Terrorism to Direct Rebuilding,” Washington Post , May 2, 2003,
+p. A1.
+
+ 
+ CRS-3
+
+In his capacity as Presidential Envoy, he will oversee Coalition reconstruction
+efforts and the process by which the Iraqi people build the institutions and
+governing structures that will guide their future.... Ambassador Bremer will
+report to Secretary of Defense Rumsfeld and will advise the President, through
+the Secretary, on policies designed to achieve American and Coalition goals for
+Iraq.11
+
+No mention was made of Lieutenant General Garner or ORHA in the press release.
+
+On May 11, 2003, the Washington Post reported the existence of the Coalition
+
+Provisional Authority.12 On May 13, 2003, the Secretary of Defense designated
+Ambassador Bremer as CPA Administrator.13 The first regulation issued by
+Ambassador Bremer, dated May 16, 2003, identified him as Administrator of CPA.
+The authority’s Inspector General (IG) stated, in his initial report to Congress, that
+OHRA became CPA in May 2003.14 However, a March 2004 DOD IG report stated
+that the Deputy Secretary of Defense, in a June 16, 2003, memorandum, dissolved
+ORHA and shifted ORHA’s functions, responsibilities, and legal obligations to
+CPA.15 Apparently, no official announcement was made at the time (that is, May or
+June 2003) that ORHA had been replaced, or subsumed, by CPA. 
+
+By June 18, Lieutenant General Garner no longer was the head of ORHA. A
+
+Department of Defense (DOD) news transcript dated June 18 identified him as the
+former director of ORHA, and indicated he had returned to the United States a couple
+of weeks earlier.16
+
+11 White House, Office of the Press Secretary, “President Names Envoy to Iraq,” May 6,
+2003, available at [http://www.whitehouse.gov/news/releases/2003/05/20030506-5.html].
+
+12 Peter Slevin, “Reject Baath Party, U.S. Tells Iraqi Job Hopefuls,” Washington Post , May
+11, 2003, p. A22.
+
+13 Donald Rumsfeld, Secretary of Defense, “Designation as Administrator of the Coalition
+Provisional Authority,” memorandum, May 13, 2003.
+
+14 U.S. Department of Defense, Office of the Inspector General, Contracts Awarded for the
+Coalition Provisional Authority by the Defense Contracting Command-Washington , p. 2.
+
+15 Ibid.
+
+16 U.S. Department of Defense, “Secretary Rumsfeld Media Availability with Jay Garner,”
+news transcript, June 18, 2003, available at [http://www.defenselink.mil/transcripts/2003/
+jun2003.html].
+
+ 
+ CRS-4
+
+ Key CPA Personnel17 
+
+ 
+
+Ambassador Bremer’s deputy was Richard Henry Jones, who was also the U.S.
+
+Ambassador to Kuwait. Ambassador Jones, who was on extended temporary duty
+(TDY) in Iraq, was assigned to the CPA position sometime in November 2003.18
+
+Sir Jeremy Greenstock, the United Kingdom’s Special Representative in Iraq,
+
+was referred to, in some news articles and documents, as a deputy to the CPA
+Administrator, or was identified as effectively serving as a deputy to Ambassador
+Bremer.19 A news bulletin produced by the U.S. Permanent Mission to the United
+Nations Office and Other International Organizations in Geneva identified Sir Jeremy
+as the CPA deputy.20 Sir Jeremy’s appointment as the United Kingdom’s Special
+Representative was announced June 16, 2003, by the Prime Minister’s official
+spokesman (PMOS). He replaced John Sawers.21 
+
+Other senior CPA officials included Rear Admiral David J. Nash, U.S. Navy
+
+(ret.), who was director of the Program Management Office (PMO), which had
+responsibility for monitoring contracts funded by the Emergency Supplemental
+Appropriations Act for Defense and the Reconstruction of Iraq and Afghanistan for
+FY2004 (FY2004 emergency supplemental).22 Rear Admiral Nash began his duties
+in July 2003. Major General Ronald L. Johnson, U.S. Army, was U.S. Deputy to the
+PMO, and also served as the commander of the Gulf Region Division of the Army
+Corps of Engineers. As of February 2004, Lawrence Crandall was the U.S. Agency
+for International Development (USAID) Deputy to the PMO. On January 20, 2004,
+Stuart W. Bowen Jr. was appointed as Inspector General by the Secretary of Defense.
+Rear Admiral Larry L. Poe, U.S. Navy (ret.), was the Deputy Inspector General.23
+
+17 For information on civilian personnel management under ORHA and CPA, see Special
+Inspector General for Iraq Reconstruction, Iraq Reconstruction: Lessons in Human Capital
+Management , Jan. 2006, available at [http://www.sigir.mil/initiatives/lessonslearned.aspx].
+
+18 Information provided by telephone by the Department of State country office for Kuwait
+and Bahrain to the author on Mar. 1, 2004.
+
+19 Ewen MacAskill, “Iraq after the War: Blair Envoy Warns Iran on Meddling,” Guardian ,
+Oct. 23, 2003, p. 4; Philip Stephens, “Now Bush Can Make a Fresh Start,” Financial Times ,
+Dec. 16, 2003, p. 23; Owen Bowcott and Brian Whitaker, “Trouble Looms after Coalition
+Tells Kurds Self Rule Can Stay,” Guardian , Jan. 6, 2004, p. 17; Anton La Guardia, “U.S.
+General Will Lead Iraqi Army,” Daily Telegraph , Mar. 11, 2004, p. 12; Patrick Cockburn,
+“Bremer Tries to Salvage Appointed-Government Plan Amid Shia Opposition,”
+ Independent , Jan. 17, 2004, p. 13. 
+
+20 Judy Aita, “Negroponte Praises Selection of Brahimi to Head Mission,” Daily Bulletin ,
+Feb. 10, 2004, p. 1, available at [http://www.cpa-iraq.org/pressreleases/20040210_UN_
+back.html].
+
+21 Prime Minister’s Office, “Press Briefing: 11AM Monday 16 June 2003,” available at
+[http://www.number-10.gov.uk/output/Page3924.asp].
+
+22 P.L. 108-106; 117 Stat. 1209.
+
+23 Coalition Provisional Authority, Office of Inspector General, “Biographies,” available
+from the author. Mr. Bowen’s biography is still available on the agency website at
+
+(continued...)
+
+ 
+ CRS-5
+
+ Establishment of CPA 
+
+Detailed information that explicitly and clearly identifies how CPA was
+
+established, by whom, and under what specific authority, is not readily available.
+Instead, there are three alternative explanations for how it was established: one
+version suggests that the President established CPA; another alternative suggests that
+CPA was established pursuant to a United Nations (U.N.) Security Council
+resolution; and the third indicates that it was created by General Tommy Franks, U.S.
+Army, who was Commander of the U.S. Central Command (CENTCOM) from July
+6, 2000, through July 7, 2003.24 As will be discussed below, these three possibilities
+are not necessarily mutually exclusive. 
+
+From the inception of CPA in 2003 until April 2005, when a Department of
+
+Justice (DOJ) document stated that General Franks had created CPA, either of the
+first two alternatives presented here seemed to be the most likely explanations for the
+establishment of CPA. The Justice Department’s statement would seem to answer
+the question of who established CPA. However, General Franks’s role was not
+revealed publicly until April 2005, nearly two years after CPA was established, and
+it is not clear whether there are any written materials that document General Franks
+having established CPA and that predate his retirement. Also, the revelation of his
+role in CPA followed other, somewhat vague and sometimes contradictory
+explanations or comments about CPA’s origin during its 13-month tenure.
+Therefore, some might suggest that either of the other two alternatives could still be
+a valid explanation for the origin of CPA. 
+
+ National Security Presidential Directive 
+
+It is possible that the CPA, as the organization that succeeded ORHA, was
+
+established by NSPD 24. Another directive, NSPD 36, dated May 11, 2004,
+suggests how the President could have used this type of document to establish a
+temporary organization within the federal government.25 One purpose of NSPD 36
+was to establish organizations that would succeed the CPA: the Iraq Reconstruction
+Management Office (IRMO), within the Department of State, and the Project and
+Contracting Office (PCO), within DOD.26 The President established both
+
+23 (...continued)
+[http://www.sigir.mil]. 
+
+24 U.S. Department of Defense, American Force Information Service, “Abizaid Set to
+Supplant Franks as CENTCOM Commander,” July 2, 2003, available at [http://www.
+defenselink.mil/news/Jul2003/n07022003_200307025.html].
+
+25 The document itself is unnumbered. However, an e-mail message from the State
+Department’s Bureau of Legislative Affairs to the author on Feb. 22, 2005, identified the
+May 11, 2004, directive as NSPD 36.
+
+26 U.S. President (G.W. Bush), “United States Government Operations in Iraq,” National
+Security Presidential Directive (unnumbered), May 11, 2004.
+
+ 
+ CRS-6
+
+organizations pursuant to 5 U.S.C. § 3161.27 This statutory provision addresses the
+employment and compensation of employees by temporary federal government
+organizations. Under Section 3161(a), a temporary organization is defined as 
+
+a commission, committee, board, or other organization that (1) is established by
+law or Executive order for a specific period not in excess of three years for the
+purpose of performing a specific study or other project; and (2) is terminated
+upon the completion of the study or project or upon the occurrence of a condition
+related to the completion of the study or project. 
+
+It bears noting that none of the organizations mentioned here — CPA, IRMO, and
+PCO — was established by executive order or statute. However, NSPD 36 addressed
+this issue in the concluding paragraph:
+
+This NSPD shall be effective immediately, shall constitute an Executive order
+solely for purposes of 5 U.S.C. 3161, and shall not be subject to Executive order
+11030 of June 19, 1962, as amended.28
+
+It is possible that the language found in NSPD 36 had been used in NSPD 24 to
+establish OHRA, and eventually the CPA, to oversee the reconstruction of Iraq.29
+
+In January 2006, the Special Inspector General for Iraq Reconstruction (SIGIR)
+
+issued a report on civilian personnel management under ORHA and CPA. By
+confirming that 5 U.S.C. § 3161 was used to hire some of the civilian personnel for
+ORHA and CPA, the report suggests that the Administration established an
+organization using this provision of the U.S. Code . An excerpt from the relevant
+section of the report follows:
+
+The primary statutory provision that was used for employing civilians in Iraq was
+Title 5, Section 3161 of the U.S. Code. The 3161 provision enables temporary
+organizations to acquire staff through temporary appointments to the excepted
+service of the Civil Service. ORHA and CPA used 3161 extensively to hire
+civilian personnel for periods of up to one year (with the possibility of
+renewal).... According to a former CPA personnel specialist, the 3161 hiring
+authority had long existed under 5 CFR 213.3199, but it had been typically used
+to fill boards or commissions. The provision was useful for rapid hiring because
+
+27 P.L. 106-398 (Division A, Title XI, Sec. 1101(a)), Floyd D. Spence National Defense
+Authorization Act, FY2001; 114 Stat. 1654, at 1654A-308.
+
+28 U.S. President (G.W. Bush), “United States Government Operations in Iraq,” p. 3.
+Executive Order 11030 governs the preparation, presentation, filing, and publication of
+executive orders and requires that executive orders be published in the Federal Register . (3
+C.F.R. 610-612 (1962).)
+
+29 The legislative history concerning temporary organizations began in 1944, with the
+enactment of Public Law 359 during the 78th Congress (31 U.S.C. § 1347). Section 213 of
+this statute prohibits the use of appropriated funds for, or by, any agency or entity
+established by executive order and “ in existence for more than one year, if the Congress has
+not appropriated any money specifically for such agency or instrumentality or specifically
+authorized the expenditure of funds by it.” Section 1347 of P.L. 97-258 codified this
+provision in Title 31 of the U.S. Code . However, 5 U.S.C. § 3161 supersedes both of these
+statutes because it was enacted at a later date. 
+
+ 
+ CRS-7
+
+it allowed appointments from outside government without the usual competition
+required under formal job classifications. The use of 3161 to staff the temporary
+stabilization and reconstruction organizations in Iraq appears to have been
+unprecedented.30 
+
+It is possible to infer, from the following excerpt from a report to Congress
+
+provided by the Office of Management and Budget (OMB), on behalf of the
+President, that the President may have played a role in creating the authority.31 Of
+particular interest are the statements that the CPA Administrator oversees all non-
+military federal government programs and activities in Iraq, and that the President
+vested the authority with executive, legislative, and judicial authority.
+
+The Administrator of the Coalition Provisional Authority (CPA) reports to the
+President through the Secretary of Defense. He oversees, directs and coordinates
+all U.S. Government (USG) programs and activities in Iraq, except those under
+the command of the Commander, U.S. Central Command (CENTCOM). 
+
+The CPA exercises powers of government temporarily in order to provide for the
+effective administration of Iraq, to restore conditions of security and stability, to
+create conditions in which the Iraqi people can freely determine their own
+political future, ... and facilitating economic recovery, sustainable reconstruction
+and development. 
+
+The CPA is vested by the President with all executive, legislative and judicial
+authority necessary to achieve its objectives, exercised consistent with relevant
+U.N. Security Council resolutions, including [U.N. Security Council] Resolution
+1483,32 and the laws and usages of war. The CPA Administrator has primary
+responsibility for exercising this authority.33
+
+The clearest statement that the U.S. government played a part in establishing the
+
+authority is found in a letter submitted to the President of the United Nations Security
+Council by the Permanent Representatives of the United States and the United
+Kingdom. Dated two days after Ambassador Bremer was appointed by President
+Bush as the Presidential Envoy to Iraq, the letter stated, in part: 
+
+30 Special Inspector General for Iraq Reconstruction, Iraq Reconstruction: Lessons in
+Human Capital Management , p. 10. (Italics added for emphasis.)
+
+31 The report responds to a requirement in Section 1506 of the Emergency Wartime
+Supplemental Appropriations Act, 2003 (P.L. 108-11; H.R. 1559). 
+
+32 U.N. Security Council Resolution 1483, which was adopted by the United Nations
+Security Council on May 22, 2003, “lifted civilian sanctions and provided for termination
+of the Oil-for-Food Programme within six months, transferring responsibility for the
+administration of any remaining activity to the Authority representing the occupying
+powers.” (United Nations, Office of the Iraq Programme Oil-for-Food, available at
+[http://www.un.org/Depts/oip/background/scrsindex.html]. U.N. Security Council
+Resolution 1483 is available at this website.)
+
+33 U.S. Office of Management and Budget, “Report to Congress Pursuant to Section 1506
+of the Emergency Wartime Supplemental Appropriations Act, 2003 (Public Law 108-11),”
+June 2, 2003 (letter), available at [http://www.whitehouse.gov/omb/legislative].
+
+ 
+ CRS-8
+
+In order to meet these objectives and obligations [disarming Iraq and providing
+for the humanitarian needs of Iraqis] in the post-conflict period in Iraq, the
+United States, the United Kingdom and Coalition partners, acting under existing
+command and control arrangements through the Commander of Coalition Forces,
+have created the Coalition Provisional Authority, which includes the Office of
+Reconstruction and Humanitarian Assistance, to exercise powers of government
+temporarily, and, as necessary, especially to provide security, to allow the
+delivery of humanitarian aid, and to eliminate weapons of mass destruction.34
+
+While this excerpt can be viewed as an acknowledgment that the United States (and
+the United Kingdom) established CPA, it does not explain how the authority was
+established, nor does it resolve the question of its organizational agency status. 
+
+Government documents supporting the notion that CPA was a federal entity
+
+(which suggests, in turn, that it was created by the President) include two presidential
+memoranda. A May 6, 2003, memorandum, as amended by a December 5, 2003,
+memorandum, stated, in part:35
+
+In accordance with Presidential direction relating to Iraq relief and
+reconstruction, multiple agencies are deployed with the Coalition Provisional
+Authority (CPA) and are serving as implementing partners or executing agents
+for programs and projects. These agencies will identify funding requirements for
+such programs and projects through CPA. OMB will work with CPA to transfer
+funds to the appropriate implementing agency.36
+
+The authority’s intimate involvement in the funding process for work done by federal
+government agencies in Iraq further suggests that the CPA is a federal entity.
+ 
+
+Language in the FY2004 emergency supplemental also stated that the CPA was
+
+part of the federal government. In describing how the apportionment of $18.649
+billion was to be carried out, P.L. 108-106 stated:
+
+Funds appropriated under this heading [Iraq Relief and Reconstruction Fund]
+shall be apportioned only to the Coalition Provisional Authority in Iraq (in its
+
+34 Sir Jeremy Greenstock, Permanent Representative of the United Kingdom, and John D.
+Negroponte, Permanent Representative of the United States, letter to the President of the
+Security Council, May 8, 2003, available at [http://www.globalpolicy.org/security/issues/
+iraq/document/2003/0608usukletter.htm].
+
+35 The Dec. 5, 2003, memorandum directed that any references in the May 6, 2003,
+memorandum to the Office of Reconstruction and Humanitarian Assistance or ORHA be
+replaced by “Coalition Provisional Authority” and “CPA,” respectively.
+
+36 U.S. President (G. W. Bush), “Memorandum on Delegation of the Functions of the
+President under the Heading ‘Iraq Relief and Reconstruction Fund’ in the Emergency
+Wartime Supplemental Appropriations Act, 2003,” Federal Register , May 9, 2003, vol. 68,
+no. 90, p. 25275; U.S. President (G. W. Bush), “Transfer of Funds Appropriated to the
+President under the heading Operating Expenses of the Coalition Provisional Authority, and
+Delegation of the Functions of the President under the heading Iraq Relief and
+Reconstruction Fund, in the Emergency Supplemental Appropriations Act for Defense and
+for the Reconstruction of Iraq and Afghanistan, 2004,” Federal Register , Jan. 9, 2004, vol.
+69, no. 6, p. 1645.
+
+ 
+ CRS-9
+
+capacity as an entity of the United States Government), the Department of State,
+the Department of Health and Human Services, the Department of Treasury, the
+Department of Defense, and the United States Agency for International
+Development ...37
+
+According to this excerpt, the authority was an entity of the federal government.
+ 
+
+Information provided by CPA itself indicated that its sector program
+
+management offices (SPMOs) were part of the federal government. (The CPA’s
+PMO was supported by six SPMOs.) In a written response to a question asked at a
+January 21, 2004, pre-proposal conference on contracting opportunities, the CPA
+stated that “the Sector Program Management Office (SPMO) is a Government
+entity.”38 
+
+Yet another organization related to CPA is on record as stating that “the U.S.
+
+government created CPA....”39 The Special Inspector General for Iraq Reconstruction
+included this statement in its January 2006 report on civilian personnel management
+under ORHA and CPA. 
+
+Nonetheless, questions remain regarding how CPA was established, who
+
+established it, the precise nature of its relationship to DOD (including DOD
+components) and other federal entities, and whether CPA was a federal agency or
+some other type of government organization. Another unanswered question concerns
+the scope of CPA’s authority when it was functioning in its capacity as an entity of
+the U.S. government. 
+
+ United Nations Security Council Resolution 1483 
+
+A second possibility is that United Nations Security Council Resolution 1483
+
+(2003) was instrumental in creating the authority, a view supported by several
+documents released by the executive branch. A solicitation issued by the Pentagon
+Renovation Office, on behalf of CPA, for procuring PMO support services, stated in
+the “overview”: “The CPA was enacted by the United Nations Security Council
+under Resolution 1483 (2003).”40 Other government documents, including the
+President’s proposed budget for FY2005 and P.L. 108-106, stated that the authority
+was established pursuant to Resolution 1483.41 This statement does not necessarily
+contradict the language found elsewhere in the FY2004 emergency supplemental
+stating that CPA is an entity of the U.S. government, for the reason discussed above.
+
+37 117 Stat. 1225.
+
+38 Coalition Provisional Authority, “List of Questions and Answers Compiled from a Pre-
+Proposal Conference Held on Jan. 21, 2004,” p. 20.
+
+39 Special Inspector General for Iraq Reconstruction, Iraq Reconstruction: Lessons in
+Human Capital Management , p. 36.
+
+40 Pentagon Renovation Office, solicitation W914NS-04-R-0001, Jan. 6, 2004, p. 2.
+
+41 U.S. Office of Management and Budget, Budget of the United States Government —
+FY2005, Appendix (Washington: GPO, 2004), pp. 958-959; P.L. 108-106; 117 Stat. 1226.
+
+ 
+ CRS-10
+
+Nevertheless, repeated references to Resolution 1483 might be viewed by some
+
+as implying that the resolution alone authorized or established a coalition-based
+organization in Iraq, or might contribute to confusion about the organizational status
+of the authority. Relevant portions of the resolution are as follows:
+
+ The Security Council , ... Noting the letter of 8 May 2003 from the Permanent
+Representatives of the United States of America and the United Kingdom of
+Great Britain and Northern Ireland to the President of the Security Council
+(S/2003/538) and recognizing the specific authorities, responsibilities, and
+obligations under applicable international law of these states as occupying
+powers under unified command (the “Authority”), ... Calls upon the Authority,
+consistent with the Charter of the United Nations and other relevant international
+law, to promote the welfare of the Iraqi people through the effective
+administration of the territory, including in particular working towards the
+restoration of conditions of security and stability and the creation of conditions
+in which the Iraqi people can freely determine their own future.42
+
+While recognizing the responsibility to be borne by the United States and the United
+Kingdom in restoring security and stability in Iraq, this resolution did not establish,
+or authorize the creation of, a specific organization to carry out this responsibility.
+In the words of a former Administrator of the Office of Federal Procurement Policy,
+the resolution “noted and recognized, but did not establish CPA.”43
+
+Lending support to the notion that the authority was not a federal agency, but
+
+instead was an amorphous international organization, are statements by the
+Department of the Army. In 2003, two protests were filed with the General
+Accounting Office (GAO; this agency was renamed the Government Accountability
+Office in 2004) by Turkcell Consortium, which challenged CPA’s issuance of
+licenses for mobile telecommunications services in Iraq. GAO dismissed both
+protests without having to rule on the status of CPA. 
+
+In a letter submitted to GAO during the protest process, the U.S. Army Legal
+
+Services Agency was unequivocal in its argument that CPA is not a federal agency:
+
+The CPA is not a Federal agency. Rather, as the HCA [CPA’s Head of
+Contracting Activity] explains: The Coalition Provisional Authority (CPA) is a
+multi-national coalition that exercises powers of government temporarily in order
+to provide for the effective administration of Iraq during the period of
+transitional administration, to restore conditions of security and stability, to
+create conditions in which the Iraqi people can freely determine their own
+political future, including by advancing efforts to restore and establish national
+and local institutions for representative governance and facilitating economic
+recovery and sustainable reconstruction and development. CPA is vested with
+all executive, legislative and judicial authority necessary to achieve its
+objectives, to be exercised under relevant U.N. Security Council resolutions,
+
+42 United Nations Security Council, Resolution 1483 (2003) , S/RES/1483(2003), May 22,
+2003, p. 2, available at [http://www.un.org/Docs/sc/unsc_resolutions.html]. (Italics in
+original.)
+
+43 Angela B. Styles, “Seller Beware: Assessing the Risks of Iraq Reconstruction
+Contracting,” Federal Contracts Report , Jan. 20, 2004, vol. 81, no. 2, p.65.
+
+ 
+ CRS-11
+
+including Resolution 1483 (2003), and the laws and usages of war. This
+authority is exercised by the CPA Administrator.
+
+The GAO does not have jurisdiction over this protest because CPA is not a
+Federal agency.... The CPA is an organization comprised of members from a
+coalition of countries.... CPA is analogous to an organization such as NATO’s
+[North Atlantic Treaty Organization’s] Stabilization Force (SFOR) in Bosnia and
+Croatia. The SFOR has its own contracting organization, the Theatre Allied
+Contracting Office (TACO), which may utilize the services of United States
+military personnel. Like the TACO, CPA is not a federal agency. Like NATO
+and SFOR, CPA is composed of an international coalition.... UN Security
+Council Resolution 1483 (2003) recognizes CPA as “the Authority” to govern
+Iraq and grants the CPA discretion to disburse funds in the Development Fund
+for Iraq (“DFI”).44
+
+While the CPA did employ individuals from coalition countries, there were at
+
+least two significant differences between CPA and SFOR. The SFOR is overseen by
+a multinational organization, the North Atlantic Treaty Organization (NATO), and
+it was authorized by United Nations Security Council Resolution 1088 (1996).45 The
+Security Council’s resolution explicitly authorized the establishment of SFOR (as it
+also did for the precursor entity, the Implementation Force (IFOR)):
+
+The Security Council ... authorizes the Member States ... to establish for a
+planned period of 18 months a multinational stabilization force (SFOR) as the
+legal successor to IFOR under unified command and control ....46 
+
+Given that P.L. 108-106 and other government documents stated that CPA was a
+U.S. government entity, the Army’s response raises questions. Arguably, the Army
+was concerned that some would assume, precisely because of references to the
+authority as a government entity, that CPA was a federal agency. Another possibility
+is that the Army, as the executive agent for the authority (discussed below), assumed
+responsibility for certain procurement activities and tasks, such as responding to
+protests, and thus argued strongly for excluding CPA from the GAO protest process.
+
+Legislative language might contribute to questions about the status of the
+
+authority. The FY2004 emergency supplemental referred to CPA as “an entity of the
+United States Government.”47 In the National Defense Authorization Act for
+FY2004, Section 1203(b)(1) mentioned “civilian groups reporting to the Secretary
+
+44 Maj. Frank A. March, Department of the Army, United States Army Legal Services
+Agency, “Protest of Turkcell Consortium, B-293048,” correspondence to U.S. General
+Accounting Office, Oct. 21, 2003, pp. 2- 4.
+
+45 North Atlantic Treaty Organization, “History of NATO-led Stabilisation Force (SFOR)
+in Bosnia and Herzegovina,” no date, available at [http://www.nato.int/sfor/docu/
+d981116a.htm]. 
+
+46 United Nations Security Council, Resolution 1088 (1996), Dec. 12, 1996, S/RES/1088,
+available at [http://www.nato.int/ifor/un/u961212b.htm].
+
+47 117 Stat. 1225.
+
+ 
+ CRS-12
+
+[of Defense], including” ORHA and CPA.48 Section 1203(b)(3) referred to the
+“relationship of Department of Defense entities, including” ORHA and CPA.49 The
+House report accompanying H.R. 1588 (P.L. 108-136), the National Defense
+Authorization Act for FY2004, in its comments on the section that became Section
+1203, mentioned “Department of Defense (DOD) civilian and military activities in
+post-conflict Iraq.”50 Eschewing the word “agency” in favor of “entity,” “group,”
+and “activities” in legislation and congressional documents could be a reflection of
+the Administration’s approach, an acknowledgment that CPA’s status was uncertain,
+or a sign that Congress agreed that CPA was not an agency.
+
+Documents produced by the Administration and the CPA do not state precisely
+
+how this organization was established. In the preface to the first regulation of the
+CPA, dated May 16, 2003, Ambassador Bremer stated: “ Pursuant to my authority as
+Administrator of the Coalition Provisional Authority (CAP), relevant U.N. Security
+Council resolutions, including Resolution 1483 (2003), and the laws and usages of
+war ...”51 In a December 2003 memorandum on contracting procedures for the
+reconstruction of Iraq, Deputy Secretary of Defense Paul Wolfowitz wrote: “The
+Coalition Provisional Authority (CPA) has been established to promote the welfare
+of the Iraqi people.”52 Neither statement identifies by whom, or under what authority,
+CPA was established.
+
+ General Franks 
+
+General Tommy Franks’s role in the creation of CPA was revealed in a brief
+
+prepared by Justice Department attorneys in April 2005 in the matter of United States
+ex rel. DRC Inc. v. Custer Battles, LLC (E. Va., No. CV-04-199-A). Custer Battles
+(CB) had done work for CPA in Iraq, and former employees of CB alleged in a
+lawsuit filed under the False Claims Act (FCA; 31 U.S.C.§§ 3729-3733) that the
+company had defrauded the federal government. Attorneys for Custer Battles
+responded, in part, that CPA was not a federal agency, so the FCA was not
+applicable. Initially, the presiding judge invited the Justice Department to state the
+government’s position on whether the FCA applied to CPA. Then, in response to a
+second order from the judge, Justice Department attorneys addressed the question,
+in a supplemental brief, of whether CPA was a U.S. government entity, agency, or
+instrumentality, and they concluded that it was an instrumentality. (See below for
+more details.)
+
+48 P.L. 108-136; 117 Stat. 1392 at 1648; H.R. 1588.
+
+49 Sec. 1203(b)(1)-(3) of P.L. 108-136.
+
+50 U.S. Congress, House Committee on Armed Services, National Defense Authorization Act
+for Fiscal Year 2004 , H.Rept. 108-106, 108th Cong, 1st sess., May 16, 2003 (Washington:
+GPO, 2003), p. 359.
+
+51 Coalition Provisional Authority, “Coalition Provisional Authority Regulation Number 1,”
+May 16, 2003, available at [http://www.iraqcoalition.org/regulations/index.html#
+Regulations]. (Italics in original.)
+
+52 Paul Wolfowitz, Deputy Secretary of Defense, “Determination and Findings,” Dec. 5,
+2003, p. 1, available from author.
+
+ 
+ CRS-13
+
+In their supplemental brief, which was also filed in April 2005, the Justice
+
+Department attorneys also offered an explanation of who established CPA:
+
+The CPA was created by the Commander of the Coalition Forces in Iraq, General
+Tommy Franks, United States Army, who was also the Commander of the U.S.
+Central Command. The establishment of the CPA by the Coalition was formally
+recognized by UNSCR [United Nations Security Council Resolution 1483].
+Since the Coalition Forces had established and exercised actual authority over
+the territory of Iraq, under the laws of war and occupation, the authority of the
+defeated Iraqi regime of Saddam Hussein passed into the hands of the Coalition
+Forces. General Franks established the CPA under the laws of war to perform
+civil government functions in liberated Iraq during the brief occupation.53
+
+This statement by the Justice Department may not settle the question of how
+
+CPA was established, by whom, and under what authority.54 The fact that CPA had
+a predecessor in ORHA raises questions about the Justice Department’s explanation
+for the origin of CPA. Although ORHA and CPA were responsible for essentially
+the same mission in Iraq, and although CPA subsumed, or succeeded, ORHA, the
+origins of these two organizations apparently differed. ORHA was established by the
+President, through NSPD 24;55 CPA was established (according to the Justice
+Department) by the Commander of CENTCOM, “under the laws of war.”56 (As
+noted above, the CPA IG stated that OHRA became CPA in May 2003,57 while the
+DOD IG indicated that the Deputy Secretary of Defense dissolved ORHA and shifted
+ORHA’s functions, responsibilities, and legal obligations to CPA.58) It is unclear
+why two different methods were used to create these organizations, and why, with
+ORHA already in place and functioning under NSPD 24, it was necessary for the
+CENTCOM Commander to establish another, new organization. 
+
+While the statement that “the authority of the defeated Iraqi regime of Saddam
+
+Hussein passed into the hands of the Coalition Forces”59 may be accurate, and while
+
+53 Supplemental Brief of the United States in response to the court’s invitation at pp. 6-7,
+ United States ex rel. DRC, Inc. and Robert Isakson v. Custer Battles, LLC , et al. (E.D. Va.
+2004) (No. CV-04-199a). 
+
+54 Justice Department attorneys noted in their supplemental brief that the discussion
+involving CPA “is solely for the purpose of answering the Court’s question with respect to
+the FCA, and not for any other purpose.” (Ibid., p. 2.) Nevertheless, this statement does not
+change the fact that the attorneys unequivocally claimed that CPA was established by
+General Franks.
+
+55 U.S. Department of Defense, Office of the Inspector General, Contracts Awarded for the
+Coalition Provisional Authority by the Defense Contracting Command-Washington , p. 1.
+
+56 Supplemental Brief of the United States at pp. 6-7.
+
+57 U.S. Department of Defense, Office of the Inspector General, Contracts Awarded for the
+Coalition Provisional Authority by the Defense Contracting Command-Washington , p. 2.
+
+58 Ibid.
+
+59 Supplemental Brief of the United States in response to the court’s invitation at pp. 6-7,
+ United States ex rel. DRC, Inc. and Robert Isakson v. Custer Battles, LLC , et al. (E.D. Va.
+
+(continued...)
+
+ 
+ CRS-14
+
+it suggests why General Franks established CPA, the statement appears to overlook
+the existence of ORHA. As noted above, ORHA had been created in January 2003,
+two months prior to the fall of Baghdad. The authority that passed into the Coalition
+Forces’ hands when they invaded Iraq presumably would have been accorded to
+ORHA. The supplemental brief apparently fails to mention not only that CPA was
+preceded by ORHA, but also that ORHA apparently was still in existence when CPA
+was established. 
+
+As noted above, it appears that the Justice Department’s supplemental brief
+
+represents the initial disclosure of the then-CENTCOM Commander’s role in
+creating CPA. However, the legal brief does not include a source for this statement,
+and it does not otherwise indicate that there is any written documentation of this
+action. It is not known how General Franks established CPA, or whether he
+prepared and signed any document to create CPA. Nevertheless, a CENTCOM
+document that appears to be a leaflet that was developed for distribution to the Iraqi
+people mentions General Franks’s role in establishing CPA.60 This document, titled
+“Freedom Message to the Iraqi People,” dated April 16, 2003, and attributed to
+General Franks (his name is included at the end of the message), includes the
+following statement: “... I am creating the Coalition Provisional Authority to exercise
+powers of government temporarily, and as necessary, especially to provide security,
+to allow the delivery of humanitarian aid and to eliminate weapons of mass
+destruction.”61 The complete text of this document is at the appendix.
+
+Despite the text included in the April 16, 2003, leaflet, DOD does not appear to
+
+have issued any statement in 2003 documenting General Franks’ decision to establish
+CPA.62 The lack of a document that implemented or authorized the creation of CPA
+
+59 (...continued)
+2004) (No. CV-04-199a).
+
+60 In its “lessons learned” report on contracting, the Office of the Special Inspector General
+for Iraq Reconstruction (SIGIR) refers to General Franks’s message as an “order.” The
+SIGIR report did not repeat or affirm General Franks’s claim that he created CPA; rather,
+SIGIR noted that “CPA initially was recognized as a discrete organization in a CENTOM
+order” issued by General Franks. (Special Inspector General for Iraq Reconstruction, Iraq
+Reconstruction: Lessons in Contracting and Procurement , July 2006, available at
+[http://www.sigir.mil/reports/pdf/Lessons_Learned_ July21.pdf], p. 23.) (italics added) It
+appears, however, that General Franks’s “Freedom Message to the Iraqi People” is not
+consistent with DOD’s definition of an “order.” “Order” is defined as “a communication,
+written, oral, or by signal, which conveys instructions from a superior to a subordinate.”
+(Department of Defense, Department of Defense Dictionary of Military and Associated
+Terms , Apr. 12, 2001 (as amended through Apr. 14, 2006), available at
+[http://www.dtic.mil/doctrine/jel/new_pubs/jp1_02.pdf], p. 395.) The text of Franks’s
+message is included in the appendix.
+
+61 General Tommy R. Franks, Commander of Coalition Forces, “Freedom Message to the
+Iraqi People,” Apr. 16, 2003, available from the author. This document (and an Arabic-
+language version) were provided electronically by U.S. Central Command, Legislative
+Liaison, to the author, July 13, 2005. 
+
+62 Ambassador Bremer’s appointment as Presidential Envoy to Iraq was the subject of a
+
+(continued...)
+
+ 
+ CRS-15
+
+also was noted by the federal judge presiding in United States v. Custer Battles , who
+wrote: “This proclamation [the April 16, 2003, leaflet] was not followed by any
+formal document or order establishing the CPA or defining its legal
+responsibilities.”63 Additionally, no mention was made of General Franks’ role in
+creating CPA during a ceremony at the White House on December 14, 2004, when
+he, Ambassador Bremer, and George Tenet, the former Director of Central
+Intelligence, were awarded Presidential Medals of Freedom by the President.64 The
+apparent lack of publicly available documentation about the creation of CPA by
+CENTCOM, and the fact that disclosure of CPA’s origins was made by the Justice
+Department and did not occur until spring 2005, might lead some to question whether
+this explanation of CPA’s creation accurately reflects what occurred in May or June
+2003.
+
+ Selected Characteristics of CPA 
+
+The asserted lack of clarity concerning authorizing authority and establishment
+
+of the CPA arguably extended to its status within the executive branch. It is not clear
+whether the authority was a federal agency, or could be treated as such. What is
+known is that the CPA was neither an executive department nor a government
+corporation. Executive departments are identified by statute, and government
+corporations are “corporation[s] owned or controlled by the Government of the
+United States.”65 If the authority was a federal government entity, it may have been
+an independent establishment, which is defined as “an establishment in the executive
+branch (other than the United States Postal Service or the Postal Rate commission)
+which is not an Executive department, military department, Government corporation,
+or part thereof, or part of an independent establishment.”66 If it is determined that the
+authority was an independent establishment, CPA also would be considered an
+executive agency.67 Other possibilities are that CPA was a component of DOD, or
+that it was not a federal government entity. Due to its unusual status, this
+examination of certain of its characteristics or features might be instructive. 
+
+ CPA’s Relationship to the Department of Defense 
+
+While it is clear that, ultimately, the CPA Administrator answered to the
+
+President, it is also clear that the Administrator reported to the Secretary of Defense
+
+62 (...continued)
+White House press release in May 2003.
+
+63 U.S. v. Custer Battles, 376 F. Supp 2d 617 (E.D. Va. 2005) at 620.
+
+64 White House, Office of the Press Secretary, “President Presents Medal of Freedom,” news
+release, Dec. 14, 2004, available at [http://www.whitehouse.gov/news/releases/2004/12/
+print/20041214-3.html]. 
+
+65 5 U.S.C. §§ 101 and 103.
+
+66 5 U.S.C. § 104(1).
+
+67 An “‘executive agency’ means an Executive department, a Government corporation, and
+an independent establishment.” (5 U.S.C. § 105).
+
+ 
+ CRS-16
+
+as well.68 Administratively, Ambassador Bremer and the authority fell under the
+Department of the Army. For Ambassador Bremer, this meant that his salary,
+Executive Level III, was paid by the Army.69 A report prepared by the Office of
+Personnel Management (OPM), dated March 10, 2004, showed that 558 federal
+government employees were detailed to CPA. The largest contingents were from the
+Department of Defense (455) and the Department of State (85). Other agencies
+contributing personnel included the Department of Transportation (2), the
+Department of the Treasury (6), the Naval Criminal Investigative Service (1), OPM
+(1), the U.S. Navy (2), and unknown (6). Three detailees were ambassadors, 65 were
+from the Foreign Service, 411 were identified as “federal civilian workers,” and the
+remaining 79 were members of the Senior Executive Service (SES).70 (CPA also
+employed individuals from coalition partner countries.71) A document available on
+the Army Civilian Personnel On-Line (CPOL) website indicated that all CPA civilian
+employees were realigned in 2003 to Army rolls.72 
+
+In 2003, the Secretary of the Army was designated the executive agent for
+
+ORHA, and, subsequently, CPA, in memoranda issued by the Deputy Secretary of
+Defense.73 Neither memorandum is publicly available, but a third memorandum,
+issued by the Deputy Secretary of Defense and dated January 14, 2004, addressed
+acquisition and program support for the authority and confirmed the existence of the
+previous memoranda:
+
+Pursuant to Section 113 of Title 10, United States Code, the Secretary of the
+Army is hereby assigned the authority and responsibility for the provision of
+acquisition and program management support to the CPA (Iraq and Washington,
+DC) and any successor entity. The Secretary of Defense shall determine and
+prioritize the requirements to be supported pursuant to this assignment of
+responsibility, as necessary. 
+
+68 White House, Office of the Press Secretary, “President Names Envoy to Iraq,”; U.S.
+Office of Management and Budget, Report to Congress Pursuant to Section 1506 of the
+Emergency Wartime Supplemental Appropriations Act, 2003 (Public Law 108-11) .
+
+69 Information provided by telephone by the DOD Office of Legislation Liaison to the author
+on Feb. 5, 2004.
+
+70 Letter from Kay Coles James, Director, Office of Personnel Management, to Hon. C. W.
+Bill Young, Chairman, House Committee on Appropriations, Mar. 10, 2004. Section 599C
+of P.L. 108-199 requires the OPM to submit a report to the House and Senate Committees
+on Appropriations on the number of employees, by agency, that are detailed to CPA. The
+initial report was due February 1, 2004, and quarterly updates were also required.
+
+71 Information provided electronically by CPA’s legislative affairs office to the author on
+Apr. 21, 2004.
+
+72 Army Civilian Personnel On-Line, “FY03: The Year in Review,” no date, available from
+the author.
+
+73 “Army Assigned Responsibility for Acquisition and Program Management Support for
+CPA,” Federal Contracts Report , Jan. 27, 2004, vol. 81, no. 3, p. 80. This article stated
+that the memorandum dated May 21, 2003, designated the Secretary of the Army Executive
+Agent for the Office of Reconstruction and Humanitarian Assistance and that the
+memorandum dated June 21, 2003, did the same for CPA. 
+
+ 
+ CRS-17
+
+For purposes of this memorandum, acquisition support is intended to include the
+award, administration and oversight of all contracts, grants, and other acquisition
+actions in direct support of the CPA and any successor entity. Program
+management support comprises all aspects of project oversight, including
+planning, scheduling and execution, as may be required by the scope of work,
+directed timelines, and applicable financial management regulations.
+
+All addressees [listed on the memorandum] shall provide support to the Secretary
+of the Army, as the Secretary of the Army considers necessary, to carry out this
+assignment of responsibility. Services and supplies provided to the CPA in
+furtherance of this memorandum shall be made available in accordance with
+DoD Instruction 4000.19 and applicable financial management regulations. My
+memoranda of May 21, 2003, designating the Secretary of the Army as Executive
+Agent for the Office of Reconstruction and Humanitarian Assistance, and June
+16, 2003, providing for the exercise of that responsibility in support of the CPA,
+are modified accordingly.74
+
+ 
+
+ The following description of a DOD executive agent indicates that executive
+
+agents are assigned responsibility for DOD missions, activities, or tasks:
+
+The Head of a DoD Component to whom the Secretary of Defense or the Deputy
+Secretary of Defense has assigned specific responsibilities, functions, and
+authorities to provide defined levels of support for operational missions, or
+administrative or other designated activities that involve two or more of the DoD
+Components. The nature and scope of the DoD Executive Agents
+responsibilities, functions, and authorities shall ... be prescribed at the time of
+assignment [and] ... remain in effect until the Secretary of Defense or the Deputy
+Secretary of Defense revokes or suspends them.75
+
+This definition would arguably cast CPA as a DOD component. A broad
+interpretation, though, might allow the Secretary, or Deputy Secretary, to appoint an
+executive agent for a non-DOD entity or even a non-governmental entity. DOD’s
+policy governing the use of executive agents leaves open this possibility. 
+
+4.1. The DoD Executive Agent designation shall be conferred when: 4.1.1. No
+existing means to accomplish DoD objectives exists. 4.1.2. DoD resources need
+to be focused on a specific area or areas of responsibility in order to minimize
+duplication or redundancy, or 4.1.3. Such designation is required by law,
+Executive order, or Government-wide regulation.76 
+
+Aside from the question of whether an executive agent can be assigned to a non-
+DOD or non-governmental entity, it appears that item 4.1.1, item 4.1.2, or both might
+have applied to the circumstances surrounding DOD and CPA. It seems likely that
+
+74 Paul Wolfowitz, Deputy Secretary for Defense, “Assignment of Responsibility for
+Acquisition and Program Management Support for the Coalition Provisional Authority,”
+memorandum, Jan. 14, 2004, available at [http://www.acq.osd.mil/sadbu/news/CPA-
+OSD00626-04.pdf].
+
+75 Department of Defense Directive 5101.1, DoD Executive Agent , Sept. 3, 2002 (certified
+current as of Nov. 21, 2003), p. 2, available at [http://www.dtic.mil/whs/directives].
+
+76 Ibid., p. 3.
+
+ 
+ CRS-18
+
+item 4.1.3 would not have applied, because no law, executive order, or government
+regulation had been enacted, issued, or produced that required or authorized the
+Army to serve as executive agent. No mention is made in the Deputy Secretary’s
+January 14, 2003, memorandum of which rationale applied to the authority.
+
+Deputy Secretary of Defense Wolfowitz did note that Department of Defense
+
+Instruction Number 4000.19 applied to the provision of supplies and services to the
+CPA. This document provides guidance for intragovernmental and interservice
+support, which are defined as follows:
+
+Intragovernmental support is support provided by a DoD activity to a non-DoD
+Federal activity and vice versa — [it] does not include support provided to or
+received from foreign governments.
+
+Interservice support is support provided by one DoD activity to a DoD activity
+of another Military Service, Defense Agency, Unified Combatant Command,
+Army Reserves, Navy Reserves, Air Force Reserves, Marine Corps Reserves, Air
+National Guard, or Field Activity.77
+
+Deputy Secretary Wolfowitz’s memorandum did not indicate whether the
+
+authority received support from the Army under an interservice or an
+intragovernmental agreement, which leaves unanswered the question of whether CPA
+was part of DOD, or simply attached to it for the purposes of facilitating coordination
+with, and receiving support from, the Department of the Army. Nevertheless, DOD
+Instruction 4000.19 clarifies that a non-DOD entity may receive support from DOD.
+In either case, intragovernmental or interservice agreement, documentation is
+required. 
+
+Broad areas of recurring interservice and intragovernmental support and
+cooperation that do not require reimbursement should be documented with a
+memorandum of agreement (MOA) or memorandum of understanding (MOU).
+Recurring interservice and intragovernmental support that requires
+reimbursement shall be documented on a DD [Department of Defense] Form
+1144, “Support Agreement”... , or similar format that contains all the information
+required on DD Form 1144. Support that benefits a receiver without creating
+additional cost to the supplier (e.g., gate guards, fire protection) may be included
+on a DD Form 1144, but must be identified as non-reimbursable. Provision of
+a single item or one time service, sales of Defense Business Operations Fund
+(DBOF) mission products and services, and intragovernmental sales specifically
+directed or authorized by law may be accomplished on the basis of an order or
+requisition without preparing a support agreement.78
+
+Apparently, documentation was required for the support agreement between the
+Army and CPA. If an applicable document exists and is available to the public, it
+might clarify what type of agreement existed between the Army and the authority. 
+
+77 Department of Defense Instruction Number 4000.19, Interservice and Intragovernmental
+Support , Aug. 9, 1995, p. 15, available at [http://www.dtic.mil/whs/directives/corres/pdf2/
+i400019p.pdf].
+
+78 Ibid., p. 4.
+
+ 
+ CRS-19
+
+ CPA Office of Inspector General 
+
+An Office of the Inspector General was established for CPA by Title III of the
+
+FY2004 emergency supplemental.79 The Secretary of Defense, in consultation with
+the Secretary of State, appointed the Inspector General, and the Inspector General
+reported to the CPA Administrator.80 As of March 20, 2004, the Office of Inspector
+General (OIG) employed 58 persons and had obtained the services of an auditing and
+accounting firm.81 
+
+In addition to having the duties, responsibilities, and authorities outlined in the
+
+Inspector General Act of 1978 (5 U.S.C. Appendix),82 the CPA Inspector General
+(IG) was authorized to “conduct, supervise, and coordinate audits and investigations
+of the treatment, handling, and expenditure of appropriated funds by the Coalition
+Provisional Authority in Iraq.”83 This involved, for example, monitoring obligations
+and expenditures, reconstruction activities, contracts, and transfers of funds and
+associated information between and among the CPA and other departments, agencies,
+and entities of the federal government.84 It seems that the CPA IG was to be treated
+the same as any federal agency’s OIG. The CPA office was to coordinate with the
+DOD and USAID Offices of Inspector General.85 Additionally, any federal
+department or agency that was asked to provide information or assistance to the CPA
+OIG was to do so.86 In his statement on the emergency supplemental, the President
+apparently placed some restrictions on CPA’s OIG. He noted that the Inspector
+General was to: 
+
+refrain from initiating, carrying out, or completing an audit or investigation, or
+from issuing a subpoena, which requires access to sensitive operation plans,
+intelligence matters, counterintelligence matters, ongoing criminal investigations
+by other administrative units of the Department of Defense related to national
+security, or other matters the disclosure of which would constitute a threat to
+national security. The Secretary of Defense may make exceptions to the
+foregoing direction in the public interest.87
+
+79 P.L. 108-106; 117 Stat. 1209, at 1234.
+
+80 Sec. 3001(c) and (e) of P.L. 108-106.
+
+81 Coalition Provisional Authority, Office of Inspector General, Message from the Inspector
+General of the Coalition Provisional Authority , p. 13.
+
+82 P.L. 95-452, Sec. 1; Oct. 12, 1978; 92 Stat. 1101.
+
+83 Sec. 3001(f)(1) and (g) of P.L. 108-106.
+
+84 Sec. 3001(f)(1) of P.L. 108-106.
+
+85 Sec. 3001 (f)(4) and (5) of P.L. 108-106.
+
+86 Sec. 3001(h)(4) of P.L. 108-106.
+
+87 U.S. President (G. W. Bush), “Statement on Signing the Emergency Supplemental
+Appropriations Act for Defense and for the Reconstruction of Iraq and Afghanistan, 2004,”
+ Weekly Compilation of Presidential Documents , vol. 39, Nov. 6, 2003, p. 1549.
+
+ 
+ CRS-20
+
+The CPA IG was to terminate its operations six months after the “authorities and
+
+duties” of CPA “cease to exist,” which occurred June 28, 2004.88 Instead, Section
+1203 of P.L. 108-375, which amended Title III of P.L. 108- 106, redesignated the
+CPA IG as the Special Inspector General for Iraq Reconstruction (SIGIR) and made
+termination of the office contingent upon the obligation of appropriated funds.89
+SIGIR is to cease operations 
+
+10 months after the date, as determined by the Secretary of State and the
+Secretary of Defense, on which 80 percent of the amounts appropriated or
+otherwise made available tot he Iraq Relief and Reconstruction Fund by chapter
+2 of title II of this Act have been obligated.90
+
+The Special Inspector General for Iraq Reconstruction reports to both the Secretary
+of Defense and the Secretary of State. 
+
+ Procurement Activities 
+
+ Appropriated Funds for the Reconstruction of Iraq. The Emergency
+
+Wartime Supplemental Appropriations Act for FY2003,91 which was the first
+supplemental to provide funds for the reconstruction of Iraq, was signed on April 16,
+2003, prior to the announcement that Ambassador Bremer would be the
+Administration’s Presidential Envoy to Iraq. Accordingly, there was no mention of
+CPA (or ORHA) in this statute. The $2.475 billion appropriated to the President for
+the reconstruction of Iraq could be apportioned only to USAID and the Departments
+of Defense, Health and Human Services (HHS), State, and the Treasury.92 
+
+The FY2004 emergency supplemental, which was signed by the President on
+
+November 6, 2003, included CPA in the list of organizations to which the Iraq Relief
+and Reconstruction Fund could be apportioned.93 The other five organizations in the
+list were the ones included in the first supplemental. 
+
+While the authority was eligible to receive funds for the reconstruction of Iraq,
+
+apparently it did not award any contracts funded by the FY2004 emergency
+supplemental. Deputy Secretary Wolfowitz’s December 5, 2003, memorandum
+identifying countries whose companies were eligible to compete for contracts funded
+by the FY2004 emergency supplemental also stated that the construction and services
+
+88 Sec. 3001(o) of P.L. 108-106.
+
+89 For additional information on SIGIR, see [http://www.sigir.mil].
+
+90 Sec. 1203(o) of P.L. 108-375.
+
+91 P.L. 108-11; 117 Stat. 559, at 573.
+
+92 “Apportion” refers to a procedure whereby the President, through OMB, distributes
+appropriated funds to executive agencies. (31 U.S.C. § 1513(b)(1). Outside the executive
+branch, “the official having administrative control of an appropriation available to the
+legislative branch, the judicial branch, the United States International Trade Commission,
+or the District of Columbia government ... shall apportion the appropriation in writing.” (31
+U.S.C. §1513(a).)
+
+93 117 Stat.1225.
+
+ 
+ CRS-21
+
+contracts funded by the supplemental “are to be awarded by the Coalition Provisional
+Authority (CPA) and by the Department of Defense, on behalf of CPA.”94
+Solicitations for the major design/build construction contracts were issued by the
+U.S. Army Corps of Engineers, the U.S. Army Communications-Electronics
+Command (CECOM), and the Naval Facilities Engineering Command. Proposals
+were to be submitted to the office that issued the solicitation. Offerors95 also were
+required to submit copies of their proposals to the Iraq Reconstruction Contracting
+Office, which was located in Alexandria, Virginia. The Pentagon Renovation Office
+issued the solicitations for support for the CPA’s Program Management Office
+(PMO) and sector PMOs. Proposals were to be submitted to the Pentagon
+Renovation Office, but there was no requirement for proposals for the program
+management office PMO and sector program management offices (SPMOs) contracts
+to be submitted to the Iraq Reconstruction Contracting Office. Solicitations were
+issued on January 6, 2004, and by March 26, 2004, all 17 contracts were awarded.96
+
+Apparently, no official explanation as to why the CPA did not issue these
+
+solicitations was offered. A possible factor in the decision to decentralize the
+solicitation, evaluation, and award processes might have been the scheduled
+termination of the CPA. Knowing that the CPA would terminate operations by June
+30, 2004, Administration officials might have chosen the route they did in order to
+maintain continuity. Another possible reason why CPA was limited to monitoring
+contracts may be that government officials ascertained that the authority did not have
+enough personnel, or enough personnel with sufficient experience in the types of
+
+94 Paul Wolfowitz, Deputy Secretary of Defense, “Determination and Findings,” available
+from the author. In this document, the Deputy Secretary used the “public interest” exception
+(see FAR 6.302-7) to full and open competition as the authority for limiting competition for
+reconstruction contracts to firms “from the United States, Iraq, Coalition partners and force
+contributing nations.” (Ibid.) It bears noting, however, that the Deputy Secretary of
+Defense did not, and does not, have authority to use or apply this exception. Under FAR
+6.302-7(c), only the Secretary of Defense, the Secretaries of the Air Force, Army, and Navy,
+the Secretary of Homeland Security for the Coast Guard, the Administrator of the National
+Aeronautics and Space Administration, and the head of any other executive agency may
+exercise this authority, which may not be delegated. 
+
+95 An offeror is a business that submits a proposal in response to a government solicitation.
+
+96 The contracts were awarded to AECOM (PMO support, $21.6 million), CH2M
+Hill/Parsons (public works and water SPMO support; $28.4 million), Berger/URS
+(transportation/communications SPMO support, $8.4 million; security/justice SPMO
+support, $8.4 million; buildings/education/health SPMO support, $10.7 million), Iraq Power
+Alliance Joint Venture (electrical services SPMO support, $43.3 million), Foster Wheeler
+(oil SPMO support, $8.4 million), Fluor AMEC LLC (power generation facilities, $500
+million; public works and water — northern region,$600 million; public works and water
+— southern region, $500 million), Washington International Inc. and Black and Veatch
+(water resources, $600 million), Washington International Inc. (electricity — northern
+region, $500 million), Perini Corp. (electricity — southern region, $500 million),
+Contrack/AICI/OCI/Archirodon Joint Venture (transportation, $325 million), Lucent
+Technologies World Services, Inc. (communications, $75 million), and Parsons Delaware
+(buildings, education, and health, $500 million; security, justice, and safety, $900 million).
+(Coalition Provisional Authority, Program Management Office, “Another Contract in Place
+to Continue Construction in Iraq,” press release, Apr. 2, 2004, available from the author.
+
+ 
+ CRS-22
+
+work to be done in Iraq, to develop solicitations and evaluate proposals for seven
+major sectors, the PMO, and the SPMOs. The fact that CPA needed contractor
+support for its PMO and SPMOs tends to support the notion that it did not have
+enough resources to perform all of the necessary procurement tasks. A third
+consideration might have been the possibility of protests, particularly the possibility
+that a contractor would file a protest with GAO challenging the authority’s actions
+or decisions concerning the award of a contract. As discussed below, a few
+companies did file protests with GAO concerning CPA decisions. Perhaps the U.S.
+government wanted to avoid the possibility that additional protests targeting CPA
+would be filed with GAO. (As noted below, CPA’s own contracting procedures
+applied only to non-appropriated funds, and only allowed for protests to be filed with
+CPA officials.)
+
+The former Administrator of the Office of Federal Procurement Policy, in
+
+writing about contracting with the authority, offered another possible explanation of
+why government officials chose to have DOD components issue solicitations and
+award contracts for the reconstruction of Iraq: 
+
+The CPA is not the United States government. Accordingly, if one enters into
+a contractual relationship with the CPA, one is not entering into a contractual
+relationship with the United States. The rights and remedies available to parties
+contracting with the United States will not be available in a contractual
+relationship with the CPA. The remedies available to an aggrieved contracting
+party will be determined in part by the source of the money through which the
+contracting party is paid.97
+
+Government officials may have considered the question of the CPA’s organizational
+status and the possibility that a contract with the authority would not be a contract
+with the U.S. government. These considerations might have contributed to a
+determination that it would not be appropriate for CPA to enter into contracts funded
+by appropriated funds. 
+
+There is some question as to whether the authority used appropriated funds for
+
+projects involving the reconstruction of Iraq. In a letter it submitted to GAO on the
+matter of the Turkcell Consortium protest (see below), the United States Army Legal
+Services Agency stated: “The funds CPA is using for contracts are not appropriated
+funds.... Even if this action [issuing licenses for mobile telecommunications] was a
+procurement that involved the use of funds, CPA would use DFI [Development Fund
+for Iraq] funds, not U.S. appropriated funds for its CPA mission.”98 This letter was
+written a few weeks before the FY2004 emergency supplemental was enacted, so
+possibly the Army was commenting only on conditions at the time. If so, then the
+Army’s assertion in the Turkcell Consortium bid protest might not have applied to
+subsequent procurement actions. 
+
+97 Angela B. Styles, “Seller Beware: Assessing the Risks of Iraq Reconstruction
+Contracting,” Federal Contracts Report , Jan. 20, 2004, vol. 81, no. 2, p. 65. (Italics in
+original.)
+
+98 Maj. Frank A. March, Department of the Army, United States Army Legal Services
+Agency, “Protest of Turkcell Consortium, B-293048,” correspondence to U.S. General
+Accounting Office, Oct. 21, 2003, pp. 3 and 4.
+
+ 
+ CRS-23
+
+Other evidence suggests that CPA used appropriated funds for reconstruction
+
+activities. A news article that mentioned the activities of the CPA’s Program Review
+Board (see below) indicates the authority spent appropriated funds:
+
+From minutes published by the CPA’s Program Review Board, it appears that the
+CPA has the power to shift monies between appropriated funds accounts and the
+Development Fund of Iraq (which contains funds from both Iraqi and foreign
+donated sources): “#352, Restore Iraqi Infrastructure, $711M. [million] The
+Board considered the request from Task Force RIO [Restore Iraqi Oil] for
+changing the funding source from appropriated funds to the Development Fund
+of Iraq a previously approved request (#352, total amount approved $962M).
+$251M was already provided from the Natural Resource Risk Remediation Fund
+(NRRRF), an appropriated funds account. TF RIO indicated that $711M is
+outstanding and required but of that amount $466M was immediately required
+to complete projects under Phase I. The Board identified $500M as remaining
+available from two appropriated accounts — the Iraq Reconstruction and Relief
+Fund (IRRF) and the NRRRF and therefore the requirement was approved to
+come from the appropriated funds. A new vote may be required for the
+remaining amount $211M but this was deferred.
+
+Agenda Item #398 (‘Police equipment - Of the $90M authorized (funding source
+to be either appropriated or DFI), the CPA’s Ministry of Interior team needs an
+immediate disbursement of $5M. This request is for the reprogramming of $5M
+from appropriated or DFI (to be determined) to vested funds. The request was
+recommended for approval.99
+
+The latter passage also shows that CPA might have reprogrammed funds among the
+various funding sources available to it (see below).
+
+ CPA Solicitations. CPA issued solicitations, which means it also awarded
+
+contracts, for some time. In early March 2004, the list on CPA’s website included
+solicitations for aerators, AK-47 assault rifles, sand bags, portable X-Ray units,
+battery cells, vehicles, berets, turbine parts, a police records management system,
+information technology products, agricultural equipment, satellite data
+communications, and railroad equipment, parts, and services.100 It is unknown what
+funds CPA used to purchase items and services listed in its solicitations. If CPA
+used Iraqi funds, then CPA Memorandum Number 4 applied. Iraqi funds were
+defined in this memorandum as: 
+
+Funds under the control of the [Coalition Provisional] Authority consisting of (a)
+proceeds from Iraqi state-owned property that has been vested or seized in
+accordance with applicable law and made available to the CPA to assist the Iraqi
+people and assist in the reconstruction of Iraq; and (b) funds in the Development
+Fund for Iraq, the establishment of which is noted in Resolution 1483 (2203).
+As used in this Memorandum, “Iraqi Funds” do not include funds provided
+through the appropriations process of Coalition member governments (for
+
+99 Christopher R. Yukins and Mohab Khattab, “Iraq Reconstruction Awards Should Not Be
+Immune from Review,” Federal Contracts Report , Nov. 18, 2003, vol. 80, no. 18, p. 512.
+
+100 The list is no longer available on the CPA website.
+
+ 
+ CRS-24
+
+example, funds provided directly to the CPA by the governments of the United
+States or the United Kingdom).101
+
+If CPA used appropriated funds, it would seem reasonable for authority personnel to
+have followed the Federal Acquisition Regulation (FAR), which governs federal
+agency procurement activities. A review of three CPA solicitations showed that two
+(sand bags and information technology) included numerous references to the FAR
+(sand bags and information technology products). The third solicitation, for berets,
+included only one reference to the FAR. Without additional, detailed information
+about the authority’s contracting activities, it is difficult to ascertain the source of
+funds and the guidance used for each procurement. The former Administrator of the
+Office of Federal Procurement Policy (OFPP) has stated that “no rules [are] in place
+for contracting by the CPA with U.S. appropriated funds.”102 In the absence of a
+clear statement on the organizational status of the CPA, however, this assessment
+may or may not be accurate. 
+
+ Program Review Board. Ambassador Bremer established, through
+
+Coalition Provisional Authority Regulation Number 3, a Program Review Board
+(PRB), which reported directly to him. The board’s general duty was to be
+“responsible for recommending expenditures of resources from the Development
+Fund for Iraq and other resources identified” elsewhere in the regulation. In
+developing funding plans, the PRB recommends disbursements of appropriated
+funds, “Iraqi property lawfully vested in the U.S. Treasury,” funds, cash, or other
+financial instruments owned by Iraq or the (former) regime, and the Development
+Fund for Iraq. A news article asserted that the PRB “really controls only the Iraqi
+money.”103 However, as noted above, a news article indicated the PRB was involved
+in spending appropriated funds. The board was also responsible for proposing
+“principles and standards for expending funds for the relief and recovery of Iraq in
+a fair, consistent and transparent manner, through contracts or otherwise.”104 
+
+The board consisted of a chairman, who was appointed by the CPA
+
+Administrator; the directors of economic policy, civil affairs policy, the USAID —
+Iraq mission, operations, and security affairs (all of whom apparently were CPA
+personnel); and authorized representatives of the commander of coalition forces, the
+Iraqi Ministry of Finance, the United Kingdom, Australia, and the chairman of the
+Council for International Coordination. If the PRB took action on any matter relating
+to the disposition of appropriated funds, then the voting membership was also to
+include authorized representatives of DOD, and Departments of the Treasury and
+
+101 Coalition Provisional Authority, “Contract and Grant Procedures Applicable to Vested
+and Seized Iraqi Property and the Development Fund for Iraq,” Coalition Provisional
+Authority Memorandum Number 4, pp. 3-4.
+
+102 Styles, “Seller Beware: Assessing the Risks of Iraq Reconstruction Contracting,” p.65.
+
+103 Jackie Spinner and Ariana Eunjung Cha, “U.S. Decisions on Iraq Spending Made in
+Private,” Washington Post , Dec. 27, 2003, p. A15.
+
+104 Coalition Provisional Authority, “Coalition Provisional Authority Regulation Number
+3, Program Review Board,” June 18, 2003, p. 7, available at [http://www.cpa-iraq.org/
+regulations/].
+
+ 
+ CRS-25
+
+State. Additionally, the status of the authorized representatives of the Iraqi Ministry
+of Finance, the United Kingdom, Australia, and Council for International
+Coordination shifted from voting to nonvoting on the disposition of appropriated
+funds. Others who were permitted to attend board meetings as nonvoting members
+included the CPA Comptroller and General Counsel; Program Coordinator of the
+board; and authorized representatives of OMB, the Office of the Secretary of
+Defense, the International Monetary Fund, the World Bank, the United Nations
+Special Representative of the Secretary General for Iraq, and the International
+Advisory and Monitoring Board.105
+
+ Protests. Protests challenging the authority were filed with GAO. On October
+
+14, 2003, GAO received a bid protest from Turkcell Consortium, which challenged
+the award of mobile telecommunications licenses in Iraq by CPA. This was the first
+protest filed that involved the authority. The protest was dismissed because it was
+based on speculation, not factual grounds, that errors occurred in the award
+process.106 Turkcell Consortium filed a second protest on October 27, 2003, which
+was also dismissed by GAO because the procurement did not involve “the provision
+of property or services to the federal government.”107
+
+While CPA was the organization that awarded the contract for mobile
+
+telecommunications licenses, GAO’s second bid protest decision identified the
+cognizant agency as “Department of the Army, for the agency.”108 Reportedly, the
+U.S. Army was also listed as the cognizant agency on GAO’s docket for the first
+protest, and the solicitation number was listed as “unknown.”109 Citing a dismissal
+request submitted by the Army, GAO stated, in its decision on the second protest:
+“The Department of the Army argued that our Office lacks jurisdiction to hear this
+protest because the CPA is not a ‘federal agency.’”110 Due to the fact that both
+protests were dismissed on other grounds, there was no need for GAO to resolve the
+question of “whether the CPA is a federal agency for purposes of our [GAO] bid
+protest jurisdiction under CICA [Competition in Contracting Act of 1984].”111 In its
+second decision on this case, however, GAO explained its authority to decide bid
+protests and described circumstances under which it could have jurisdiction to handle
+bid protests concerning CPA:
+
+105 Ibid., pp. 3-4.
+
+106 Melanie I. Dooley, “GAO Dismisses Turkcell Protest of Iraq Telecom Licenses; Turkcell
+Files New Protest after Receiving Debriefing,” Federal Contracts Report , BNA, Inc., Oct.
+28, 2004, vol. 80, no. 15. p. 405.
+
+107 Melanie I. Dooley, “GAO Dismisses Turkcell’s Second Protest of Iraq Telecom Licenses
+but Leaves Door Open,” Federal Contracts Report , Nov. 18, 2003, vol. 80, no. 18, p. 507.
+
+108 U.S. General Accounting Office, Turkcell Consortium bid protest, file B-293048.2, Nov.
+12, 2003, p. 1.
+
+109 Melanie I. Dooley, “GAO Dismisses Turkcell Protest of Iraq Telecom Licenses; Turkcell
+Files New Protest after Receiving Debriefing,” Federal Contracts Report , Oct. 28, 2003,
+vol. 80, no. 15, p. 405.
+
+110 U.S. General Accounting Office, Turkcell Consortium bid protest, p. 2.
+
+111 Ibid., p. 1; 31 U.S.C. §§ 3551-3556.
+
+ 
+ CRS-26
+
+The authority of our Office to decide bid protests is based on the Competition in
+Contracting Act of 1984 (CICA) ... and encompasses “a written objection by an
+interested party to a solicitation or other request by a federal agency for offers
+for a contract for the procurement of property or services.” Our jurisdiction does
+not turn on whether appropriated funds are involved ... or on whether the
+competition requirements of CICA apply.
+
+We note ... that even if we ultimately determine that the CPA is not a federal
+agency, we may well assume jurisdiction if the challenged procurement is
+conducted on the CPA’s behalf by an entity that is a federal agency (such as the
+Department of the Army).... In any event, we would also consider a request by
+the CPA for our Office to consider protests outside the framework of CICA.112
+
+CPA’s award of a contract to Nour USA to equip the Iraqi armed forces and the
+
+Iraqi civil defense corps also was the subject of protests. A solicitation was issued
+on November 11, 2003, and CPA (which was explicitly identified as the contracting
+activity in the press release) received 19 bids.113 In a press release dated January 31,
+2004, CPA announced that it had awarded a contract for $327 million to Nour USA.
+
+In mid-February, it was reported that two companies, Cemex Global Inc. and
+
+Bumar Group, had filed separate protests, which were combined by GAO into one
+protest, challenging the awarding of this contract to Nour USA. Among their
+concerns were (1) the relatively low cost of the Nour USA proposal, which was $231
+million lower than the Bumar Group’s proposal; (2) the fact that Nour’s president
+was A. Huda Faouki, who allegedly is a friend of Ahmad Chalabi, who had been a
+member of the Iraqi Governing Council; and (3) the belief that Nour USA, which
+apparently was established in May 2003, had no experience in performing the work
+necessary to fulfill the terms of the contract.114 Subsequently, four additional protests
+were filed with GAO. In each of the six protests, the Department of the Army was
+listed as the cognizant agency and the solicitation number (FY5866-04-R-0001) was
+included.115 Reportedly, CPA indicated on March 3 that it would reevaluate all
+timely proposals and make a new source selection decision.116 In light of the
+government’s decision to reevaluate proposals, GAO dismissed all protests.117 In a
+March 5, 2004, press release, the CPA PMO briefly described plans for rectifying the
+situation, which involved the Army, but not CPA:
+
+112 U.S. General Accounting Office, Turkcell Consortium bid protest, pp. 2-3.
+
+113 Coalition Provisional Authority, Program Management Office, “U.S.-Iraqi-Polish Group
+Receives Security Equipment Contract,” press release, Jan. 31, 2004.
+
+114 Joe Harper, “Polish Arms Company Challenges CPA Award to U.S. Firm, Alleges Bid
+Evaluation Unfair,” Federal Contracts Report , Feb. 24, 2004, vol. 81, no. 7, p. 199; Melanie
+I. Dooley, “Coalition Provisional Authority to Review Nour, Other Offerors to Equip Iraq
+Army,” Daily Report for Executives , Mar. 5, 2004, no. 43, p. A-24.
+
+115 The file numbers assigned by GAO to these protests were B-293676.001 through B-
+293676.006. 
+
+116 Dooley, “Coalition Provisional Authority to Review Nour, Other Offerors to Equip Iraq
+Army,” p. A-24.
+
+117 Ibid.
+
+ 
+ CRS-27
+
+Today the Army announced it will terminate its contract with Nour, USA, to
+equip the New Iraqi Army. Protests were filed subsequent to the award to Nour.
+Protests are part of a transparent and fair procurement process. As a result of an
+internal review, the Army has determined there were irregularities in this specific
+contract action, and took appropriate measures to assess the validity of the
+protests.
+
+The Army will conduct a complete re-solicitation; schedule release of the
+solicitation is to be determined. The Army wants to ensure the process is
+transparent, fair and conduct in an expeditious manner.118
+
+Reportedly, control of the procurement process transferred from CPA to the Army
+Materiel Command.119
+
+No explanation was provided as to why the Army terminated the contract when
+
+the press release that announced the award of a contract to Nour identified CPA as
+the contracting activity (see above). A possible question could be posed, for
+example, why CPA, if it was the organization that awarded the contract initially, did
+not cancel the contract. While the Department of the Army provided support to CPA,
+particularly in the area of acquisition, it is unclear how, why, or under what
+circumstances, a federal agency might cancel a contract awarded by another entity
+and assume responsibility for subsequent procurement activities. 
+
+Neither CPA nor DOD disclosed why the Department of the Army, and not the
+
+authority, was listed on GAO’s bid protest docket for protests involving contracting
+actions apparently undertaken by CPA. As for reconstruction contracts funded by the
+FY2004 supplemental, the fact that DOD components, such as the Army Corps of
+Engineers and the Naval Facilities Engineering Command, were the contracting
+activities would seem to preclude the possibility that an offeror would file a protest
+with GAO challenging CPA. Considering the Department of the Army’s assertion,
+during the protest by Turkcell Consortium, that CPA was not an agency, it suggests
+that there might have been some (unknown) advantages to shielding CPA from
+protests.120 Without further information about CPA’s procurement process and
+organizational status, it is unclear whether any advantages existed, and, if so, what
+they might have been.
+
+It is unknown whether any offerors filed protests under the provisions of
+
+Coalition Provisional Authority Memorandum Number 4, which, as noted above,
+provided procurement rules for what may be referred to collectively as Iraqi, or non-
+appropriated, funds. The paragraph on protests stated:
+
+A contractor wishing to object to the terms of a solicitation, the termination of
+a solicitation, the award of a contract, or the termination of the award of a
+
+118 Coalition Provisional Authority, Program Management Office, “U.S. Army Terminates
+Contract to Equip New Iraqi Army,” Mar. 5, 2004.
+
+119 Abby Bowles, “Army Materiel Command Put in Charge of Resoliciting Iraq Army
+Equipment Contract Awarded to Nour,” Federal Contracts Report , Mar. 16, 2004, vol. 81,
+no. 10, p. 279.
+
+120 March, “Protest of Turkcell Consortium, B-293048,” pp. 2- 4.
+
+ 
+ CRS-28
+
+contract, shall present the matter to the Contracting Officer for an initial
+decision. The contractor shall state to the Contracting Officer the basis for the
+protest. If the contractor does not agree with the Contracting Officer’s initial
+decision, the Contractor may appeal the initial decision to the Head of
+Contracting Activity, CPA, for resolution. The decision of the Head of
+Contracting Activity, CPA, shall be the final decision in the matter.121
+
+Not only did this provision fail to provide for any sort of external, independent
+review or adjudication process (such as provided by GAO), it also omitted any
+requirements or procedures for CPA personnel to respond in a timely fashion, or to
+provide an explanation for their decision.
+
+ Appropriated Funds for the Operating Expenses of CPA. The
+
+FY2004 supplemental (P.L. 108-106) appropriated $933 million to the President for
+the authority’s operating expenses. Expenses could have included “personnel costs,
+transportation, supply, equipment, facilities, communications, logistics requirements,
+studies, physical security, media support, promulgation and enforcement of
+regulations, and other activities needed to oversee and manage the relief and
+reconstruction of Iraq and the transition to democracy ....”122 These funds are “to
+remain available until September 30, 2005: Provided , That the appropriation of funds
+under this heading shall not be construed to limit or otherwise affect the ability of the
+Department of Defense to furnish assistance and services, and any other support, to
+the Coalition Provisional Authority.”123 In a memorandum dated December 5, 2003,
+the President transferred these funds to the Secretary of Defense:
+
+The funds appropriated to the President under the heading Operating Expense of
+the Coalition Provisional Authority in the Emergency Supplemental
+Appropriations Act for Defense and for the Reconstruction of Iraq and
+Afghanistan, 2004 (Public Law 108-106), or in any subsequent appropriation
+under this heading, are transferred to the Secretary of Defense, for an account
+designated Operating Expenses of the Coalition Provisional Authority,
+International Reconstruction and Other Assistance, Army.124
+
+Information is not available to explain whether the CPA Administrator had access to
+these funds, or if he relied on the Secretary of Defense for purchasing supplies and
+equipment needed by CPA.
+
+121 Coalition Provisional Authority, “Contract and Grant Procedures Applicable to Vested
+and Seized Iraqi Property and the Development Fund for Iraq,” p. B-3.
+
+122 117 Stat. 1226.
+
+123 Ibid.
+
+124 U.S. President (G. W. Bush), “Transfer of Funds Appropriated to the President under the
+heading Operating Expenses of the Coalition Provisional Authority, and Delegation of the
+Functions of the President under the heading Iraq Relief and Reconstruction Fund, in the
+Emergency Supplemental Appropriations Act for Defense and for the Reconstruction of Iraq
+and Afghanistan, 2004,” Federal Register , Jan. 9, 2004, vol. 69, no. 6, p. 1645.
+
+ 
+ CRS-29
+
+ Regulatory Authority 
+
+The CPA Administrator exercised rule-making authority, which apparently was
+
+derived from the executive authority invested in CPA by the President. Unlike the
+heads of federal agencies, however, the Administrator did not follow the
+Administrative Procedure Act (APA), which governs informal and formal rule
+making.125 For example, the authority did not announce any proposed, interim, or
+final regulations in the Federal Register . 
+
+The first regulation issued by CPA outlined the Administrator’s authority in
+
+issuing regulations, memoranda, orders, and public notices:126 
+
+In carrying out the authority and responsibility vested in the CPA, the
+Administrator will, as necessary, issue Regulations and Orders. Regulations
+shall be those instruments that define the institutions and authorities of the CPA.
+Orders are binding instructions issued by the CPA. Regulations and Orders will
+remain in force until repealed by the Administrator or superseded by legislation
+issued by democratic institutions of Iraq. Regulations and Orders issued by the
+Administrator shall take precedence over all other laws and publications to the
+extent such other laws and publications are inconsistent. The Administrator may
+also from time to time issue Public Notices.... The Administrator may issue
+Memoranda in relation to the interpretation and application of any Regulation or
+Order.127
+
+Enacting a regulation, order, memorandum, or public notice was accomplished by the
+Administrator signing off on, or approving, the document. Subjects of these
+documents included: 
+
+! Regulations: Development Fund for Iraq, Program Review Board,
+
+Governing Council of Iraq, Council for International Coordination,
+Iraq Property Claims Commission, and International Donor
+Assistance; 
+
+! Orders: Penal Code, Management and Use of Iraqi Public Property,
+
+Prohibited Media Activity, Regulation of Oil Distribution, Creation
+of a New Iraqi Army, and Status of the Coalition, Foreign Liaison
+Missions, Their Personnel and Contractors;
+
+! Memoranda: Criminal Procedures, contract and Grant Procedures,
+
+Implementation of De-Baathification Order No. 1, Implementation
+of Weapons Control Order 3, and Appointment of Deputy Ministers;
+
+125 5 U.S.C. §§ 551-559; 60 Stat. 237. See CRS Report RL31839, The Federal Regulatory
+Process: An Overview , by Gary L. Galemore.
+
+126 A list of CPA regulations, orders, memoranda, and public notices is available at
+[http://www.iraqcoalition.org/regulations/index.html], visited Feb. 24, 2005.
+
+127 Coalition Provisional Authority, “Coalition Provisional Authority Regulation Number
+One,” p. 2.
+
+ 
+ CRS-30
+
+! Public notices: Managing Financial Resources, Regarding a
+
+Responsible Iraqi Media, Regarding the Council for International
+Coordination, Regarding Public Incitement to Violence and
+Disorder.128
+
+ CPA Organization Chart 
+
+An undated CPA organization chart is shown in Figure 1 . 129 While several sub-
+
+units are missing, and it is possible that the actual organization varied from this
+depiction, the chart provides insight into the authority’s chain of command and
+organizational scope. Organizational subunits and positions not shown on the chart
+include the Deputy Administrator, Office of Inspector General, Program
+Management Office and Sector Program Management Offices, legislative affairs staff
+(which was located in the Washington, DC, metropolitan area), and contracting
+offices (apparently, there were two contracting offices, one each in Iraq and the
+Washington, DC, metropolitan area).
+
+128 Coalition Provisional Authority, “CPA Official Documents” website, available at
+[http://www.cpa-iraq.org/regulations/index.html#Regulations], visited Feb. 24, 2005.
+
+129 Organization chart provided electronically by CPA’s legislative affairs office to the
+author on Feb. 24, 2004.
+
+ 
+ CRS-31
+
+ Figure 1. Coalition Provisional Authority 
+
+Counselors
+
+Chairman, Council for Interntional Cooperation 
+
+JTF-7
+
+ Administrator 
+
+(CIC)
+
+(U.S. Army)
+
+Military Liaison Officers 
+
+(LNOs) 
+
+Deputy CIC
+
+Chief of Staff
+
+Contributing Countries
+
+(COS)
+
+Intelligence
+
+Director
+
+General C
+
+ 
+
+ounsel
+
+Humanitarian 
+
+Nongovernmental 
+
+Military Aides/Personal Staff
+
+ Executive Secretariat
+
+Affairs
+
+Organizations
+
+(NGOs)
+
+Operational Support Group 
+
+Financial Oversight
+
+UN Specialized
+
+Office of Policy Planning
+
+Agencies
+
+Steering Group
+
+Director Office of 
+
+Director
+
+Director 
+
+Director of Operations 
+
+Director of Economic 
+
+Director of Private 
+
+Management & 
+
+Oil Policy
+
+Governance
+
+and Infrastructure
+
+Development
+
+Sector Development
+
+Budget
+
+Industry &
+
+Electricity
+
+Comptroller
+
+Central
+
+Marketing
+
+Infrastructure & 
+
+Minerals
+
+Bank
+
+Utility Policy
+
+Economic
+
+State-owned
+
+Oil Operations
+
+Public Works
+
+Program Review
+
+Policy
+
+enterprises 
+
+Tiger Team 
+
+Board
+
+Finance
+
+(SOEs)
+
+Oil Pipeline 
+
+Management
+
+Planning and 
+
+Financial 
+
+Transport & 
+
+Debt 
+
+Security 
+
+Budgeting
+
+Institutions
+
+Trade
+
+Communication
+
+Restructuring
+
+Policy Guidance
+
+Private Sector
+
+Production
+
+ Regional 
+
+Agriculture
+
+Initiatives
+
+Advisors
+
+Sales
+
+Commercial Attache/
+
+ Senior Advisors
+
+Housing
+
+Business Center
+
+Governor level
+
+Irrigation
+
+Privitization Policy
+
+Director
+
+Director
+
+Corporate 
+
+Director
+
+Director
+
+Director
+
+U.S. Agency for 
+
+Strategic 
+
+Sponsorship
+
+Civil Affairs
+
+Interior Affairs
+
+Security Affairs
+
+International 
+
+Communications
+
+Development -Iraq
+
+Culture
+
+Spokesman, 
+
+(USAID)
+
+Education
+
+Customs 
+
+Civilian Affairs
+
+New Iraqi Army 
+
+Enforcement
+
+Foreign Affairs 
+
+Disaster Assistance
+
+(NIA)
+
+Press Office
+
+Health
+
+Response Team
+
+Immigration
+
+ Higher Education 
+
+Information
+
+ (DART)
+
+ Justice 
+
+Operations
+
+Labor & Social Affairs
+
+Police
+
+Reconstruction
+
+Spokesman, 
+
+Religious Affairs 
+
+ 
+
+Military Affairs
+
+Youth
+
+ 
+ CRS-32
+
+ Statutory Reporting Requirements Concerning CPA 
+
+ and the Reconstruction of Iraq 
+
+Even prior to the inception of the CPA, Congress established reporting
+
+requirements concerning efforts to reconstruct Iraq. Table 1 lists significant
+reporting requirements concerning this effort and, in particular, CPA.
+
+ 
+ CRS-33
+
+ Table 1. Statutory Reporting Requirements Concerning the CPA and the Reconstruction of Iraq 
+
+ Responsible Official or 
+
+ Summary of Content of 
+
+ Statute (date of enactment) 
+
+ Recipient(s) 
+
+ Deadline(s) 
+
+ Office 
+
+ Report 
+
+P.L. 108-11, Sec. 1506(a)
+
+President
+
+House and Senate
+
+Not later than 45 days after
+
+1. Description of duties,
+
+(April 16, 2003)
+
+Committees on
+
+date of enactment.
+
+roles, and responsibilities of
+
+Appropriations
+
+U.S. government agencies,
+foreign governments, and
+international organizations. 
+2. A strategy for coordinating
+the activities of these entities.
+3. Cost estimates associated
+with such activities and a
+strategy for distributing
+responsibility for paying
+costs associated with
+reconstruction activities.
+
+P.L. 108-11, Sec. 1506(b)
+
+President
+
+House and Senate
+
+Not later than 90 days after
+
+1. Separate lists of
+
+(April 16, 2003)
+
+ 
+
+Committees on
+
+date of enactment and every
+
+reconstruction activities that
+
+ 
+
+Appropriations
+
+90 days thereafter until Sept.
+
+are anticipated, or were
+
+30, 2004.
+
+initiated or completed.
+2. Cost estimates for
+conducting proposed
+activities and source of
+funds.
+3. Updated list of financial
+
+ 
+ CRS-34
+
+ Responsible Official or 
+
+ Summary of Content of 
+
+ Statute (date of enactment) 
+
+ Recipient(s) 
+
+ Deadline(s) 
+
+ Office 
+
+ Report 
+
+pledges and contributions
+made by foreign
+governments or international
+organizations.
+
+P.L. 108-106, Sec. 2202(b)
+
+CPA Administrator, or
+
+1. House Committees on
+
+Not later than seven calendar
+
+Justification of the use of
+
+(Nov. 6, 2003) 
+
+agency head
+
+Appropriations, Government
+
+days before the award of a
+
+other than full and open
+
+ 
+
+Reform, and International
+
+contract under other than full
+
+competition procedures, a
+
+Relations
+
+and open competition
+
+description of the scope of
+
+2. Senate Committees on
+
+procedures.
+
+the contract, a description of
+
+Appropriations, Government
+
+[Sec. 2202(b) does not
+
+the process the agency used
+
+Affairs, and Foreign
+
+include an expiration date.] 
+
+in identifying and soliciting
+
+Relations
+
+offers, the amount of the
+contract, and justification and
+approval documents.
+
+P.L. 108-106, Sec. 2203
+
+CPA Administrator ,or
+
+Publish in the Federal 
+
+Not later than seven days
+
+Amount and scope of the
+
+(Nov. 6, 2003)
+
+agency head
+
+ Register and post on the CPA
+
+before the date on which a
+
+contract, how contractors
+
+website.
+
+contract is entered into for
+
+were identified and solicited,
+
+contracts awarded under
+
+justification and approval
+
+other than full and open
+
+documents. 
+
+competition procedures.
+[Sec. 2203 does not include
+an expiration date.]
+
+P.L. 108-106, Sec. 2207
+
+Director, OMB, in
+
+House and Senate
+
+Not later than January 5,
+
+1. Proposed uses of funds for
+
+ 
+ CRS-35
+
+ Responsible Official or 
+
+ Summary of Content of 
+
+ Statute (date of enactment) 
+
+ Recipient(s) 
+
+ Deadline(s) 
+
+ Office 
+
+ Report 
+
+(Nov. 6, 2003)
+
+consultation with CPA
+
+Committees on
+
+2004. Updated reports are to
+
+Iraq relief and reconstruction
+
+Administrator and the House
+
+Appropriations
+
+be submitted to the
+
+2. Distribution of duties and
+
+and Senate Committees on
+
+committees every three
+
+responsibilities regarding
+
+Appropriations
+
+months. Sec. 2207 expires on
+
+reconstruction projects
+
+October 1, 2007. 
+
+among U.S. government
+agencies
+3. Funds provided by foreign
+governments and
+international organizations
+4. Foreign assets seized or
+frozen.
+
+P.L. 108-106, Sec. 2215(a)
+
+CPA Administrator
+
+1. House and Senate
+
+Initial report due within 30
+
+Iraqi oil production, oil
+
+(Nov. 6, 2003)
+
+Committees on
+
+days after date of enactment. 
+
+revenues, and uses of oil
+
+Appropriations
+
+Subsequent reports due on a
+
+revenues.
+
+2. Post on CPA’s website
+
+monthly basis until
+September 30, 2006.
+
+P.L. 108-106, Sec. 3001(i)(1)
+
+CPA Inspector General
+
+1. Senate Committees on
+
+Not later than March 30,
+
+A detailed statement of all
+
+and (4), (j)
+
+Appropriations, Armed
+
+2004, and every calendar
+
+obligations, expenditures,
+
+(Nov. 6, 2003)
+
+Services, and Foreign
+
+quarter thereafter.
+
+and revenues associated with
+
+Relations
+
+[Apparently, this requirement
+
+reconstruction and
+
+2. House Committees on
+
+will continue until OIG
+
+rehabilitation activities in
+
+Appropriations, Armed
+
+expires, which will happen
+
+Iraq (including the operating
+
+Services, and International
+
+six months after CPA is
+
+expenses of CPA and a
+
+Relations
+
+dissolved. (Sec. 3001(o).)]
+
+discussion of how CPA used
+
+ 
+ CRS-36
+
+ Responsible Official or 
+
+ Summary of Content of 
+
+ Statute (date of enactment) 
+
+ Recipient(s) 
+
+ Deadline(s) 
+
+ Office 
+
+ Report 
+
+3. Post on CPA website
+
+other than full and open
+
+4. CPA Administrator
+
+competition procedures).
+
+P.L. 108-106, Sec. 3001(i)(3)
+
+CPA Inspector General
+
+1. Senate Committees on
+
+Not later than June 30, 2004,
+
+Summary of the activities of
+
+and (4), (j)
+
+Appropriations, Armed
+
+and semiannually thereafter.
+
+the OIG in the previous six
+
+(Nov. 6, 2003)
+
+Services, and Foreign
+
+[Apparently, this requirement
+
+months (for example, 
+
+Relations
+
+will continue until OIG
+
+significant problems, abuses,
+
+2. House Committees on
+
+expires, which will happen
+
+and deficiencies, and OIG’s
+
+Appropriations, Armed
+
+six months after CPA is
+
+recommendations for
+
+Services, and International
+
+dissolved. (Sec. 3001(o).)]
+
+corrective action).
+
+Relations
+3. Post on CPA website
+4. CPA Administrator
+
+P.L. 108-136, Sec. 1203
+
+Secretary of Defense
+
+Congress
+
+Not later than 90 days after
+
+Range of infrastructure
+
+(Nov. 24, 2003)
+
+date of enactment.
+
+reconstruction, civil
+administration, humanitarian
+assistance, interim
+governance, and political
+development activities
+undertaken in Iraq by DOD
+officials and those civilians
+reporting to the secretary. A
+A required element is a
+discussion of the evolution of
+the organizational structure
+
+ 
+ CRS-37
+
+ Responsible Official or 
+
+ Summary of Content of 
+
+ Statute (date of enactment) 
+
+ Recipient(s) 
+
+ Deadline(s) 
+
+ Office 
+
+ Report 
+
+of the civilian groups
+(ORHA and CPA) reporting
+to the Secretary. 
+
+P.L. 108-199, Sec. 599C
+
+OPM
+
+House and Senate
+
+Initial report due February
+
+Number of detailees, by
+
+(Nov. 25, 2003)
+
+Committees on
+
+1, 2004. Subsequent reports
+
+agency, that are detailed to
+
+Appropriations
+
+due every quarter until May
+
+CPA.
+
+2005.
+
+ 
+ CRS-38
+
+ Status and Characteristics of CPA as 
+Related to the False Claims Act (FCA) 
+
+A lawsuit filed under the False Claims Act (FCA; 31 U.S.C. §§ 3729-3733), and
+
+unsealed in 2004, revealed that, as part of its defense, Custer Battles, LLC (CB),
+contended that CPA was not a federal agency. Because the FCA applies only to the
+submission of false or fraudulent claims to the government, Custer Battles argued
+that if CPA were not part of the government, the FCA would not apply. (CPA has
+been identified as the contracting agency for two contracts awarded to Custer Battles
+involving the Baghdad International Airport (BIAP) and the Iraqi Currency Exchange
+(ICE).)130 In United States ex rel. DRC Inc. v. Custer Battles, LLC (E. Va., No. CV-
+04-199-A), two former employees of CB alleged “that security contractor Custer
+Battles (CB) submitted $50 million in fraudulent contract claims” to the federal
+government.131 Custer Battles argued that CPA was not part of the U.S. government
+and that it (CB) was paid with seized funds and DFI funds, which meant, therefore,
+that the U.S. government was not involved in these contracting activities and U.S.
+government funds were not expended.
+
+Although some may concur with the judge’s 2006 analysis of the status of CPA
+
+(see below), arguably the significance of Custer Battles , aside from the outcome, may
+have more to do with the insight provided by Department of Justice attorneys and
+Judge T.S. Ellis, III.132 In a brief dated April 1, 2005, and submitted to Judge Ellis,
+DOJ attorneys examined two issues related to financial transactions involving Custer
+Battles and the BIAP and ICE contracts:
+
+Thus, the specific issue to be determined is whether the money which defendants
+[Custer Battles] requested from the CPA via their invoices under these two
+
+130 Brief of the United States in response to the court’s invitation at p. 19, United States ex
+rel. DRC, Inc. and Robert Isakson v. Custer Battles, LLC , et al. (E.D. Va. 2004 ) (No. CV-
+04-199a).
+
+131 Martha A. Matthews, “District Court Sets Feb. 10 Hearing on Whether FCA Reaches
+Coalition Provisional Authority Contracts, Development Fund for Iraq Monies,” Federal
+Contracts Report , Jan. 11, 2005, p. 24. In addition to the lawsuit filed by two former
+employees, the Air Force suspended Custer Battles effective Sept. 30, 2004. (Excluded
+Parties List System, available at [http://epls.arnet.gov].) As reported in the Legal Times , the
+Air Force suspension memorandum stated that the company had “purchased cabins, trucks,
+and equipment and created false leases between CB and the sham companies, making it
+appear that the sham companies were leasing the goods to the CPA through CB. The
+scheme allowed CB to lease the goods to the CPA at prices exceeding the original cost of
+the goods.” (Jason McLure, “How a Contractor Cashed in on Iraq,” Legal Times , Feb. 28,
+2005, p. 13.) 
+
+132 The Department of Justice (DOJ) is permitted to join a suit filed under the FCA, but it
+has been reported that the department declined in 2004 to join the lawsuit filed against
+Custer Battles.(McLure, “How a Contractor Cashed in on Iraq,” p. 13.) Subsequently, in
+December 2004, Judge T. S. Ellis III, who heard the case in the U.S. District Court for the
+Eastern District of Virginia, invited the federal government “to file ... a brief setting forth
+the government’s position with respect to whether the FCA [False Claims Act] applies to
+false claims made or presented to the CPA....” (McLure, “How a Contractor Cashed in on
+Iraq,” p. 13.) 
+
+ 
+ CRS-39
+
+contracts was to be paid out, provided or approved by the United States
+Government. The answer lies in the nature of the funds used to fund these two
+contracts. The second issue is whether the claims were presented to U.S.
+Government officials.133
+
+The Department of Justice determined that the U.S. government possessed,
+controlled, and/or administered the funds used to pay Custer Battles; the U.S.
+government paid out, approved, or provided these funds; and Custer Battles had
+presented claims for funds to “an officer or employee of the United States
+Government or to a member of the Armed Forces of the United States.”134 Following
+from these determinations, the Justice Department attorneys concluded that 
+
+Custer Battles’s claims presented to the CPA under the BIAP and ICE contracts
+would violate FCA if the claims are shown to have been knowingly false because
+those claims were for funds in which the U.S. had an interest or exercised certain
+dominion and were to be paid out, provided or approved by the United States and
+they were ultimately presented to an officer or employee of the United States
+government.135
+
+ 
+
+In response to an order from the U.S. district court, dated April 12, 2005, Justice
+
+Department attorneys filed a supplemental brief that addressed the question of
+whether CPA was a U.S. government entity, agency, or instrumentality for the
+purposes of the FCA. In their supplemental brief, the attorneys emphasized several
+times that determining the status of CPA was unnecessary, yet they did present a set
+of criteria for determining whether CPA was part of the U.S. government for the
+purposes of the False Claims Act.136 Their criteria and excerpts from their responses
+follow:
+
+How and under what circumstances was the entity created? The CPA was
+created by the Commander of the Coalition Forces in Iraq, General Tommy
+Franks, United States Army, who was also the Commander of the U.S. Central
+Command. The establishment of the CPA by the Coalition was formally
+recognized by UNSCR [United Nations Security Council Resolution] 1483.
+
+Is the entity subject to the general supervision and direction of the Executive
+Branch? Is its head appointed by the President and confirmed by the Senate?
+The CPA Administrator was subject to the direction of the President.
+
+133 Brief of the United States at p. 27.
+
+134 Brief of the United States at pp. 28-30, 34-35, 37, 39.
+
+135 Ibid., p. 40.
+
+136 As reported in the Washington Post , “The briefs came after multiple requests from
+[Judge] Ellis, who chided the Justice Department ... for only reluctantly weighing in on the
+case. Ellis said it may be because the government doesn’t want to expose itself to liability
+for the CPA’s actions. [Justice Department attorney Michael F.] Hertz acknowledged that
+the government had written its briefs in the case ‘as narrowly as [it] could’.” (Griff Witte,
+“Judge Considers Whistle-Blowers’ Iraq Contracting Suit,” Washington Post , May 13, 2005,
+p. E3.)
+
+ 
+ CRS-40
+
+Administrator Bremer served as Presidential Envoy and reported to the President
+through the Secretary of Defense.
+
+Is the entity’s funding or its capital formed or replaced out of the public treasury?
+And are any gains returned to the public treasury? The CPA’s operating funds
+were appropriated by Congress. 
+
+Are all of the entity’s officers and other personnel employees of the United
+States? Many if not most officers and employees of the CPA were employees of
+the United States. Others were employees of other member states of the
+Coalition.
+
+Are there close budgetary, auditing and fiscal controls that resemble those
+imposed on the ordinary government agency? While Congress initially imposed
+no close budgetary, auditing and fiscal controls over the CPA operations with
+regard to the DFI [Development Fund for Iraq] that resemble those imposed on
+the ordinary government agency ... , Congress created the Office of Inspector
+General for the CPA to perform those types of oversight functions.
+
+Is the structure of the entity simply an administrative device established for the
+purpose of carrying out a federal program with public funds? The CPA was the
+administrative device that the Coalition created under the laws and usages of war
+to perform civil government functions in liberated Iraq during the brief period of
+occupation. As an active member of the Coalition, the United States played an
+important role in, and had certain responsibilities for, the occupation, which it
+chose to fulfill through creation of and participation in the CPA. The CPA’s
+structure was not established by Congress, and thus, the structure is not the
+typical congressionally created administrative device to fulfill a government
+function.137
+
+In reaching their determination that CPA was an instrumentality of the U.S.
+government, the Justice Department attorneys wrote:
+
+... two factors tip the scale in favor of the conclusion that the CPA should be
+deemed to be an instrumentality of the United States for purposes of the False
+Claims Act. First is the nature of the appointment and supervision of
+Ambassador Bremer as Presidential Envoy and Administrator of the CPA. All
+authority of the CPA rested in the Administrator, and Ambassador Bremer was
+employed by the United States, served at the pleasure of the President, and was
+under the supervision of the President and the Secretary of Defense. Second,
+coupled with the status of Ambassador Bremer, is the fact that all of the money
+used for the two contracts at issue in this case was spent only on the authority
+and control of an officer or employee of the United States or a member of the
+Armed Forces of the United States.... Thus, while we emphasize again that the
+answer to the Court’s latest question on the nature of the CPA is not necessary
+to determine whether or not defendants violated the FCA when they presented
+claims to the CPA under the two contracts at issue in this litigation, we
+
+137 Supplemental Brief of the United States at pp. 6-12.
+
+ 
+ CRS-41
+
+nevertheless conclude that the CPA is an instrumentality of the United States for
+purposes of the False Claims Act.138
+
+In July 2005, Judge Ellis issued an opinion, noting first that, if CPA had been
+
+a U.S. government agency, the question of whether the FCA applied to CPA contract
+actions “would be largely resolved.”139 However, the judge went on to note that “the
+essential nature of the CPA is shrouded with ambiguity ... the CPA’s origins are
+difficult to pin down, as there is no formal document — whether statute, United
+Nations Security Council resolution, or other organic document — that plainly
+establishes the CPA or provides for its formation. “140 Near the end of his opinion,
+the judge suggested that the question of CPA’s status might need to be addressed
+again at some later date: “Although it initially appeared otherwise, it now appears
+unnecessary to reach and decide at this time whether the CPA is an instrumentality
+of the United States .... [T]he dispute as to the nature of the CPA may ultimately
+prove to be material ....”141
+
+Judge Ellis then turned to the question of the source and ownership of the three
+
+funds in question — vested funds, seized funds, and the Development Fund for Iraq
+(DFI)142 — and determined that the FCA applies to vested and seized funds, but it
+does not apply to the DFI.143 Specifically, he ruled that “any request submitted to the
+CPA for payment from Seized or Vested Funds constitutes a ‘claim’ within the
+meaning of the FCA. Requests for payment from funds in the DFI, however, were
+requests for Iraqi funds and thus did not constitute an FCA ‘claim.’” Judge Ellis’s
+ruling permitted the case against Custer Battles to go forward — because vested and
+seized funds were used to pay the BIAP contract, and seized funds were used, in part,
+to pay for the ICE contract — and, in March 2006, it was reported that a jury found
+that CB had “submitted $3 million in false claims against funds seized by the United
+States ....”144 However, in August 2006, Judge Ellis issued a second opinion in
+response to Custer Battles’ request for a directed judgment overturning the jury’s
+verdict. He ruled in favor of Custer Battles, noting that the “relators did not prove
+that the claims were presented to the United States.”145
+
+138 Ibid., pp. 13-14.
+
+139 Custer Battles , 376 F. Supp. 2d at 620.
+
+140 Ibid.
+
+141 Custer Battles , 376 F. Supp. 2d at 620 and 649. (Italics in original.)
+
+142 Vested funds are “Iraqi funds [that were] confiscated by the President and vested in the
+Department of the Treasury.” Seized funds are “Iraqi state assets, primarily in the form of
+currency and negotiable instruments, [that were] seized by the Coalition Forces occupying
+Iraqi territory.” The Development Fund for Iraq includes proceeds from the U.N. “Oil for
+Food” program, revenues from the sale of Iraqi oil and gas, international donations, and
+repatriated Iraqi assets. ( Custer Battles , 376 F. Supp. 2d at 623 and 626.)
+
+143 Ibid. 
+
+144 Martha A. Matthews, “Jury Finds Custer Battles Made $3M in False Claims under One
+Iraq Contract,” Federal Contracts Report , vol. 85, no. 10, p. 283.
+
+145 U.S. v. Custer Battles, No. 04-199, 2006 U.S. Dist. LEXIS 58217 at *2 (E.D. Va. Aug.
+
+(continued...)
+
+ 
+ CRS-42
+
+In crafting his 2006 opinion, Judge Ellis concluded that it was necessary to
+
+address the question of CPA’s status. After revisiting the analysis of CPA included
+in his 2005 opinion, the judge wrote:
+
+... [T]he result of that analysis is clear — although the CPA was principally
+controlled and funded by the U.S., this degree of control did not rise to the level
+of exclusive control required to qualify as an instrumentality of the U.S.
+government. See Rainwater , 356 U.S. at 592-54. In fact, the evidence clearly
+establishes that it was created through and governed by multinational
+consent....146 
+
+ 
+
+ Custer Battles has yielded two views of the status of CPA: DOJ attorneys
+
+determined, for the purposes of the FCA, that it was an instrumentality of the U.S.
+government, but Judge Ellis reasoned that it was not. Additionally, at least one
+alternative explanation still exists regarding the creation of CPA, which was
+discussed above. That is, the President may establish an organization under 5 U.S.C.
+§ 3161. However, without access to NSPD 24, which apparently created, or
+authorized the establishment of, ORHA, and which also may have been the
+instrument under which CPA was created, it is difficult to ascertain whether this
+could be a valid alternative explanation, or the definitive explanation. 
+
+Yet another possibility is that CPA was a hybrid organization, meaning that it
+
+had multiple origins. Perhaps, then, the seemingly contradictory explanations
+actually are a reflection of the organization’s hybrid status. Furthermore, if CPA was
+a hybrid organization, could this mean that it was part U.S. government organization
+and part multinational organization? If so, how might this arrangement have affected
+how CPA operated, what would the implications have been for CPA’s activities, and
+to whom was CPA accountable?
+
+The differing interpretations offered by Justice Department attorneys and Judge
+
+Ellis and the questions surrounding NSPD 24 highlight the difficulties inherent in
+attempting to discern the true origins of CPA. Thus, it appears that the question of
+how CPA was established, by whom, and under what circumstances remains
+unanswered, at least for some. 
+
+ Discussion of CPA 
+
+The status of this organization remains open to question. A letter exists that
+
+states that the United States, and the United Kingdom, created the authority; in 2005,
+
+145 (...continued)
+16, 2006). The term “relator” refers to a private individual who may “bring a lawsuit on
+behalf of the United States, where the private person has information that the named
+defendant has knowingly submitted or caused the submission of false or fraudulent claims
+to the United States.” (U.S. Department of Justice, “False Claims Act Cases: Government
+Intervention in Qui Tam (Whistleblower) Suits,” n.d., available at
+[http://www.usdoj.gov/usao/pae/Documents/fcaprocess2.pdf], p. 1.)
+
+146 U.S. v. Custer Battles, 2006 U.S. Dist. LEXIS 58217 at *31.
+
+ 
+ CRS-43
+
+Justice Department attorneys identified General Franks as the individual who
+established CPA; and the possibility exists that the organization’s origins are to be
+found in NSPD 24. No explicit, unambiguous, and authoritative statement has been
+provided that declares how CPA was established, under what authority, and by
+whom, and that clarifies the seeming inconsistencies among alternative explanations
+for how CPA was created.
+
+Perhaps this ambiguity allowed the authority to perform multiple roles, each
+
+with its own chain of command, stakeholders or constituents, funding, and
+accountability policies and mechanisms. A statement in the FY2004 emergency
+supplemental — “in its [CPA] capacity as an entity of the United State government”
+ — suggested that U.S. government entity is only one of CPA’s roles. Other roles
+might have included temporarily aiding in the governing of Iraq and serving as part
+of a coalition. Possibly, the mix of arrangements allowed CPA to operate with
+greater discretion and more authority, and have access to more resources, than if it
+had been solely a federal agency, or an arm of the United Nations.147 CPA personnel
+also might have been able to work more efficiently and effectively under this mix.
+By operating under more than one set of laws, regulations, and policies, CPA
+possibly could have expanded the scope and reach of the organization’s authority
+beyond what it would be otherwise. For example, the CPA Administrator drafted the
+regulations, orders, memoranda, and public notices that applied to Iraq; and the
+Program Review Board had jurisdiction over four funding sources, including
+appropriated funds. An advantage of having the CPA treated as part of the
+Department of Defense is that the chain of command ran through the executive
+branch, which would not have been the case if CPA were purely an international
+organization or coalition. 
+
+147 In a briefing on contracting programs in Iraq, Lawrence Di Rita, Principal Deputy
+Assistant Secretary of Defense for Public Affairs, stated: “We’re in a war, we’re in a global
+war on terror. We have — many of the restrictions on how money is appropriated and spent
+are based on rules and statutes that have developed over a course of time that was not a
+period of war. So we’ve got a certain disconnect between the need to spend money quickly
+now, and we’ve got certain funds available to do that — the CERP [Commanders
+Emergency Response Program] is a pot of money that’s got fewer restrictions, relatively
+speaking, attached to it. It is certainly understandable that a military commander who just
+knows if he had $10 million he can address some issues, isn’t going to necessarily be the one
+who’s patient enough to sort through all the peacetime restrictions on the use of funds.
+That’s somebody else’s job; people are doing that. These restriction are real, they were put
+in place for a very good reason. But they’re restrictions that bear some scrutiny now that
+we’re trying to address a problem that is real time; and it’s not only a real-time problem, it’s
+a real-time problem where people are being killed.... But I can tell you that the people who
+are responsible, who have that more — who have that broader view of how this money is
+allocated and what those restrictions are, are working through the problem in a very
+aggressive way — Ambassador Bremer, General Abizaid, General Sanchez.... We have a
+lot of restrictions on the way some money can be spent, fewer restrictions on the way other
+money can be spent, and we’re trying our best to kind of make those determinations all the
+time.” (Rear Admiral David J. Nash (ret.), Director, CPA Program Management Office, and
+Lawrence Di Rita, Principal Deputy Assistant Secretary of Defense for Public Affairs,
+“Briefing on Contracting Programs,” news transcript, Mar. 10, 2004, available at
+[http://www.defenselink.mil/transcripts/archive.aspx].)
+
+ 
+ CRS-44
+
+Billing itself as an international coalition, while eschewing the label “federal
+
+agency,” might be construed as an effort to make the organization more palatable, at
+least symbolically, to Iraqis and others. For example, the CPA website address ended
+“.com” and the PMO website ended “.net.” United States government website
+addresses typically end “.gov.” Furthermore, the Iraqi flag is the only flag that
+appeared on the two websites. No flags from coalition countries were displayed.
+ 
+
+Potential drawbacks of this arrangement were that the lines of authority and
+
+accountability could have become tangled, or even obscured. CPA personnel
+possibly could have found it difficult to understand and delineate clearly — on a
+daily basis — the organization’s different roles and associated funds, laws, and
+rules.148 Personnel might have been hampered by this tangle of resources, laws, and
+documents, and could have found themselves engaging in questionable, and perhaps
+unethical or criminal, activities. This scenario also could have proven challenging for
+organizations that attempted to monitor CPA and its activities. When the authority
+made a decision or expended funds, it might not have been clear to external parties
+under what authority it was acting. Without transparency, the CPA might have given
+the appearance of shifting funds, personnel, and tasks among different roles. Further
+compounding the problem, oversight initiatives might have been met with the
+response that the activity in question was carried out under an authority over which
+the oversight body — Congress — had no jurisdiction. 
+
+While greater transparency possibly could have helped to clarify CPA’s role(s),
+
+knowing how CPA was established and under what authority would go a long way
+in helping to determine whether it was a federal agency, the scope of its authority,
+and the forms, types, and mechanisms of accountability to which it was subject.
+These questions remain relevant even after CPA’s dissolution on June 28, 2004, for
+questions remain about what it did, how it spent money, and what it accomplished.
+While information gleaned from CPA personnel would be potentially useful in the
+near future, it also could be useful in the long-term in informing any future efforts to
+provide aid to countries faced with similar problems.
+
+148 In testimony provided to the Senate Committee on Homeland Security and Governmental
+Affairs, the Special Inspector General for Iraq Reconstruction suggested that the multitude
+of procurement rules was problematic. Under the heading “Policy and Process Key
+Lessons,” he advised: Establish a single set of simple contracting regulations and procedures
+that provide uniform direction to all contracting personnel in contingency environments.
+The contracting process in Iraq reconstruction suffered from the variety of regulations
+applied by diverse agencies, which caused inconsistencies and inefficiencies that inhibited
+management and oversight. (U.S. Congress, senate Committee on Homeland Security and
+Governmental Affairs, statement of Stuart W. Bowen, Jr., Special Inspector General for Iraq
+Reconstruction, unpublished hearing, 109th Cong., 2nd sess., Aug. 2, 2006, available at
+[http://hsgac.senate.gov/_files/080206Bowen.pdf].)
+
+ 
+ CRS-45
+
+ Post-CPA Organizations 
+
+ Iraq Reconstruction Management Office (IRMO) 
+and Project and Contracting Office (PCO) 
+
+On June 28, 2004, the Coalition Provisional Authority ceased operations and the
+
+United States established diplomatic relations with the Iraqi government.149 Two
+organizations were established by National Security Presidential Directive (NSPD)
+36, dated May 11, 2004, to carry on some of the work of the CPA: the Iraq
+Reconstruction Management Office (IRMO), within the Department of State; and a
+Project and Contracting Office (PCO), within DOD.150 IRMO is responsible for
+“facilitat[ing] the transition in Iraq.”151 The PCO
+
+manages the $18.4 billion appropriated by the U.S. Congress [P.L. 108-106] to
+support the reconstruction of Iraqi infrastructure. This office is responsible for
+all activities associated with program, project, asset, construction and financial
+management of that portion of the reconstruction effort undertaken by the U.S.152
+
+ Office for Reconstruction and Stabilization 
+
+In 2004, the Department of State established the Office of the Coordinator for
+
+Reconstruction and Stabilization (S/CRS) pursuant to Section 408 (Division D) of
+P.L. 108-447, the FY2005 Consolidated Appropriations Act. The office is
+responsible for, among other things, monitoring and inventorying the non-military
+resources and capabilities of executive agencies, monitoring unstable situations
+around the world, and planning for response efforts to crises in other countries or
+regions.153 
+
+ Conclusion 
+
+The Coalition Provisional Authority represented a multinational effort to rebuild
+
+Iraq, restore stability, and aid in establishing an interim Iraqi government. While its
+mission statement was fairly clear, other aspects of the authority were more obscure,
+particularly how it was established, under what authority, and by whom (within the
+U.S. government). Available information about the authority found in materials
+
+149 U.S. Mission Iraq, International Press Center, Office of Strategic Communications,
+“Ambassador Negroponte Arrives in Baghdad,” news release, June 28, 2004, received by
+email, June 28, 2004.
+
+150 U.S. President (G.W. Bush), “United States Government Operations in Iraq,” p. 3.
+
+151 Ibid., pp. 2-3.
+
+152 Iraq Project and Contracting Office, “About PCO,” n.d., available from the author. The
+url for the PCO has remained the same: it is [http://www.rebuilding-iraq.net]. 
+
+153 For additional information, see CRS Report RS22031, Peacekeeping and Post-Conflict
+Capabilities: The State Department’s Office for Reconstruction and Stabilization , by Nina
+M. Serafino and Martin A. Weiss.
+
+ 
+ CRS-46
+
+produced by the Administration alternatively (1) denies that it was a federal agency;
+(2) states that it was a U.S. government entity or instrumentality; (3) suggests that it
+was enacted under United Nations Security Council Resolution 1483; (4) refers to it,
+and OHRA, as “civilian groups ... reporting to the Secretary [of Defense]”;154 (5)
+states that it was created by the United States and United Kingdom; and (6) asserts
+that it was established by the then-Commander of CENTCOM. Without a clear,
+unambiguous statement that declares the CPA’s organizational status, clarifies what
+its relationship was with DOD and other federal agencies, and addresses the
+competing explanations for how it was created, various questions are left
+unanswered, including whether, and to what extent, CPA might be held accountable
+for its programs, activities, decisions, and expenditures. 
+
+154 Sec. 1203 of P.L. 108-136.
+
+ 
+ CRS-47
+
+ Appendix 
+
+This is the text of the document issued by General Tommy R. Franks on April
+
+16, 2003, to the Iraqi people. The heading or title of the message is “Freedom to the
+Iraqi People.”
+
+Peace be upon you. Coalition Forces in Iraq have come as liberators, not as
+conquerors. We have come to eliminate an oppressive and aggressive regime
+that refused to comply with UN Security Council resolutions requiring the
+destruction of weapons of mass destruction. The Coalition is committed to
+helping the people of Iraq heal their wounds, build their own representative
+government, become a free and independent people and regain a respected place
+in the world. We will ensure that Iraq’s oil is protected as a national asset of and
+for the Iraqi people. Iraq and its property belong to the Iraqi people and the
+Coalition makes no claim of ownership by force of arms. Coalition forces
+respect the Iraqi people, their religious practices, history and culture, and will
+safeguard Iraq’s unity and territorial integrity. 
+
+We are working with the international community to ensure the delivery of
+humanitarian assistance and to promote law and order so that Iraqis can live in
+security, free from fear. We are establishing the stability that will allow early
+progress toward political freedom and economic prosperity. Our stay in Iraq will
+be temporary, no longer than it takes to eliminate the threat posed by Saddam
+Hussein’s weapons of mass destruction, and to establish stability and help Iraqis
+form a functioning government that respects the rule of law and reflects the will,
+interests, and rights of the people of Iraq. Meanwhile, it is essential that Iraq
+have an authority to protect lives and property, and expedite the delivery of
+humanitarian assistance to those who need it. Therefore, I am creating the
+Coalition Provisional Authority to exercise powers of government temporarily,
+and as necessary, especially to provide security, to allow the delivery of
+humanitarian aid and to eliminate weapons of mass destruction. To facilitate
+these objectives, I proclaim the following: 
+
+Members of the armed forces and security organizations shall lay down their
+arms, stay away from their weapons, and remain in place. They shall obey the
+orders of the nearest Coalition military commander. All other Iraqi should
+continue their normal daily activities; officials should report to their places of
+work until told otherwise. All those engaged in the delivery of essential services
+should return to their jobs. The Arab Socialist Renaissance Party of Iraq (Hizb
+al-Ba’th al-Arabi al-Ishtiraki al-Iraqi) is hereby disestablished. Property of the
+Ba’th Party should be turned over the Coalition Provisional Authority. Saddam
+Hussein’s intelligence and security apparatus, the Al-Mukhabarat al-Iraqiyya, is
+hereby deprived of all powers and authority. All Iraqis are not free to express
+their views without fear of retribution. At an appropriate time, free elections will
+make Iraqis self-governing in local, regional, and soon, national affairs. All
+parties and political groups may participate in Iraq’s political life, except those
+who advocate or practice violence. Iraqis must not seek revenge. There will be
+a just legal process that will safeguard the honor and dignity of the Iraqi people.
+The Coalition Provisional Authority will seek a fair and prompt solution to the
+problem of displaced persons and refugees. There will be a legal, organized
+process to address restitution of homes that have been seized by the former
+regime. The Coalition will work with Iraqis to set up a commission to deal with
+such claims. I call upon Iraqis to inform Coalition Forces regarding the location
+of weapons of mass destruction or related materials, facilities where such
+
+ 
+ CRS-48
+
+weapons are made, and individuals connected to weapons of mass destruction.
+All records concerning these activities should be preserved. Iraqis should not
+pass weapons of mass destruction to terrorists or terrorist organizations. I call
+upon Iraqis to inform Coalition Forces regarding the location of: foreign fighters
+and terrorists; members of the regime’s security apparatus; and individuals who
+have perpetrated crimes against humanity or war crimes. All records concerning
+these activities should be preserved. Rewards may be provided for especially
+important information on these matters. All barriers to free movement of people
+and goods, including illegal roadblocks and checkpoints, must come down. We
+will work with regional leaders, entities, and governments that are committed to
+peace and democracy to integrate them into the Coalitions’ activities. Coalition
+Forces are here to ensure safety and security, and to help the people of Iraq create
+a better future for their country. We pledge our support to all Iraqis who seek
+Iraq’s freedom and prosperity, and the blessings of peace and security. 
+
+16 April 2003
+General Tommy R. Franks
+Commander of Coalition Forces155
+
+155 General Tommy R. Franks, Commander of Coalition Forces, “Freedom Message to the
+Iraqi People,” Apr. 16, 2003, available from the author.
\ No newline at end of file
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+Poverty in the United States in 2019 
+
+April 13, 2021 
+
+Calendar year 2019 was the last full year before the start of the Coronavirus Disease 2019 
+(COVID-19) pandemic, and the last year of the economic expansion since the Great Recession. 
+
+ Joseph Dalaker 
+
+The strength of the U.S. economy in 2019 was reflected in low poverty rates —the percentage of 
+
+Analyst in Social Policy 
+
+the population living in poverty (economic hardship characterized by low income)—for the 
+
+ 
+
+nation and by demographic group. 
+
+ 
+
+While the 2019 poverty estimates do not reflect people’s incomes during the pandemic, the 
+pandemic affected survey data collection for that year, which took place February-April 2020. Instead of a combination of in-
+person interviews and telephone interviews, only telephone interviews were conducted due to social distancing restrictions. 
+That affected the estimates because some respondents were harder to reach by phone than in person, less likely to respond to 
+a telephone interview than an in-person interview, or less likely to respond for other reasons. The increased rate of 
+nonresponse affected persons with low incomes to a greater degree than persons with high incomes. That means that while 
+poverty in 2019 was at or close to a historic low, it was likely not as low as the official estimates suggest. 
+
+Bearing the above caveats in mind, the poverty rate in the United States was estimated to be 10.5% in 2019, down from 
+11.8% in 2018. This was the fifth year in a row that the poverty rate declined. The decline in poverty was broad based, 
+affecting many demographic groups and occurring in every region of the country. The estimated poverty rate fell 
+
+ both for women (11.5% in 2019, from 12.9% in 2018) and men (9.4%, from 10.6%); 
+ among families with a female householder and no spouse present (22.2% in 2019, from 24.8% in 2018), the 
+
+latest of a series of historic or near-historic lows for this group; 
+
+ among Hispanics (15.7% in 2019, from 17.6% in 2018), Whites not of Hispanic origin (7.3%, from 8.1%), 
+
+Blacks (18.8%, from 20.8%), and Asians (7.3%, from 10.1%); 
+
+ for both full-time workers (2.0% in 2019, from 2.3% in 2018) and nonworkers (26.4%, from 29.7%); and 
+ in 23 states and the District of Columbia. 
+
+Work reduces the estimated likelihood of being in poverty but does not eliminate it entirely: 39.2% of poor 18 to 64-year-
+olds had jobs in 2019. Furthermore, poverty is measured using the needs and resources from the entire family, meaning that 
+nonworkers in poverty may be living with working family members. A mong 18- to 64-year-olds without jobs estimated to be 
+living in poverty, 19.2% lived in families where someone else worked. 
+
+Criticisms of the official poverty measure have inspired poverty measurement research and eventually led to the development 
+of the Supplemental Poverty Measure (SPM). The SPM uses different definitions of needs and resources than the official 
+measure. 
+
+ The SPM includes adjustments to reflect geographic variations in housing costs, and the estimated effects 
+
+of taxes and in-kind benefits (such as housing, energy, and food assistance) on poverty, while the official 
+measure does not. Because some types of tax credits and noncash benefits are used to assist the poor, the 
+SPM may be of interest to policymakers. 
+
+ The estimated poverty rate under the SPM (11.7%) was about 1.3 percentage points (after rounding) higher 
+
+in 2019 than the official poverty rate (10.5%). 
+
+ Under the SPM, the profile of the poverty population is slightly different than under the official measure. 
+
+Compared with the official measure, estimated poverty rates under the SPM in 2019 were lower for 
+children (12.5%, compared with 14.4%) and higher for working-age adults (11.2%, compared with 9.4%) 
+and the 65-and-older population (12.8%, compared with 8.9%). 
+
+ While the SPM reflects more current measurement methods, the official measure provides a comparison of 
+
+the poor population over a longer period, including some years before many current antipoverty assistance 
+programs had been developed. In developing poverty-related legislation and conducting oversight on 
+programs that aid the low-income population, policymakers may be interested in these historical trends. 
+
+Congressional Research Service 
+
+ 
+
+ 
+ link to page 4 link to page 6 link to page 7 link to page 8 link to page 8 link to page 9 link to page 10 link to page 11 link to page 12 link to page 13 link to page 13 link to page 14 link to page 16 link to page 8 link to page 9 link to page 10 link to page 11 link to page 13 link to page 13 link to page 17 link to page 17 link to page 15 link to page 17 Poverty in the United States in 2019 
+
+ 
+
+ Contents 
+
+ Introduction ................................................................................................................... 1 
+
+ How the Official Poverty Measure is Computed ............................................................. 3 
+
+ Historical Perspective ...................................................................................................... 4 
+ Poverty by Demographic Group ........................................................................................ 5 
+
+ Family Structure........................................................................................................ 5 
+
+ Age ......................................................................................................................... 6 
+ Race and Hispanic Origin ........................................................................................... 7 
+ Work Status .............................................................................................................. 8 
+
+ Poverty Rates by State ..................................................................................................... 9 
+ Supplemental Poverty Measure ....................................................................................... 10 
+
+ How the Official Poverty Measure Was Developed ....................................................... 10 
+ Motivation for a Supplemental Measure ...................................................................... 11 
+
+ Official and Supplemental Poverty Findings for 2019.................................................... 13 
+
+ 
+
+ Figures 
+ Figure 1. Number of Persons in Poverty and Poverty Rate: 1959 to 2019 ................................. 5 
+ Figure 2. Poverty Rates of Families by Family Structure: 2019 .............................................. 6 
+ Figure 3. Poverty Rates by Age: 1959 to 2019 ..................................................................... 7 
+ Figure 4. Poverty Rates by Race and Hispanic Origin: 2019 .................................................. 8 
+ Figure 5. Percentage of People in Poverty in the Past 12 Months by State and for the 
+
+ District of Columbia and Puerto Rico: 2019 ................................................................... 10 
+
+ Figure 6. Poverty Rates Under Official Measure and Supplemental Poverty Measure for 
+
+ the United States, by Age and by Region: 2019 ............................................................... 14 
+
+ 
+
+ Tables 
+ Table 1. Differences Between the Official and Supplemental Poverty Measures ...................... 12 
+ 
+
+ Contacts 
+
+ Author Information ....................................................................................................... 14 
+ 
+
+Congressional Research Service 
+
+ 
+
+ 
+ Poverty in the United States in 2019 
+
+ 
+
+ Introduction 
+ Calendar year 2019 was the last full year before the start of the Coronavirus Disease 2019 
+(COVID-19) pandemic, and the last year of the economic expansion since the Great Recession. 
+
+The strength of the U.S. economy in 2019 was reflected in low poverty rates —the percentage of 
+the population living in poverty (economic hardship characterized by low income)—for the 
+nation and by demographic group. This report presents poverty data for the United States over 
+time, as wel as by demographic group (family structure, age, race and Hispanic origin, and work 
+status) and state for 2019. The numbers presented in the report are estimates, based on a survey 
+
+(discussed below). 
+
+The official, annual data on income and poverty are measured retrospectively by a Census Bureau 
+survey conducted in February, March, and April of the following year.1 Most of the survey data 
+
+collection for 2019 took place in March 2020, after the COVID-19 pandemic had begun and 
+when social distancing measures were beginning to be implemented. As a result, any interviews 
+that would have been conducted in person, by a field representative visiting respondents at their 
+homes, were conducted by telephone only.2 The switch to telephone-only interviewing 
+contributed to a lower response rate, which affected the estimates.3 Further, the persons who did 
+not respond were more likely to have had low incomes than high incomes.4 This drop in survey 
+
+response tempers the conclusions that may be drawn from the data. 
+
+The estimated official poverty rate in 2019 was measured at a seemingly record-low 10.5%. After 
+
+taking account of survey bias—in this case, the artificial y lower poverty rates caused by higher 
+nonresponse among those with low incomes than those with high incomes—the U.S. poverty rate 
+was estimated to have been 11.1% in 2019 (tying the previous low of 11.1% in 1973).5 That is, 
+
+ 
+1 T he Current Population Survey (CPS), the source of most of the data in this report, asks an extra set of questions (the 
+Annual Social and Economic Supplement, or ASEC) in February, March, and April, with most of the data collection 
+taking place in March, in order to obtain detailed information about the previous year’s income. According to the U.S. 
+Census Bureau, “It was thought that since March is the month before the deadline for filing federal income tax returns, 
+respondents were likely to have recently prepared tax returns or be in the midst of preparing such returns and could 
+report income more accurately than at any other time of the year.” U.S. Census Bureau, Current Population Survey: 
+Design and Methodology, T echnical Paper 66, October 2006, Chapter 11, “ Current Population Survey Supplemental 
+Inquiries,” p. 11-5, https://www.census.gov/prod/2006pubs/tp-66.pdf. 
+2 T he CPS is usually conducted using both telephone interviewing and in -person interviewing. For details, see U.S. 
+Census Bureau, Current Population Survey: Design and Methodology, T echnical Paper 66, October 2006, 
+https://www.census.gov/prod/2006pubs/tp-66.pdf. 
+
+3 Response rates to the survey were approximately 9 to 10 percentage points lower than they had been in previous years 
+(73.0% in 2020 compared with 81.5% in 2019 and 83.7% in 2018). T his decreased response rate could have many 
+contributing causes, such as a respondent’s lack of a telephone, difficulties in finding a telephone number associated 
+with a household selected for the survey, some respondents’ lower willingness to respond to a telephone call than to an 
+in-person visit, or other reasons. 
+4 Every year, when processing the CPS ASEC data, the Census Bureau applies weighting procedures that attempt to 
+correct for nonresponse, so that totals by age, sex, race, and Hispanic origin match independently computed totals 
+based on administrative data. T hese procedures reduced but did not eliminate nonresponse bias. In a research paper 
+(i.e., separate from the official reports), Census Bureau analysts estimated the likely effects of nonresponse bias on the 
+2019 income and poverty estimates. For a detailed analysis of the lower response to the CPS ASEC conducted in 2020, 
+see Jonathan Rothbaum and Adam Bee, Coronavirus Infects Surveys Too: Nonresponse Bias During the Pandem ic in 
+the CPS ASEC, U.S. Census Bureau, working paper number SEHSD WP2020 -10, September 2020, at 
+https://www.census.gov/library/working-papers/2020/demo/SEHSD-WP2020-10.html. A succinct and less technical 
+explanation by Jonathan Rothbaum is available on the Census Bureau’s “ Research Matters” blog at 
+https://www.census.gov/newsroom/blogs/research-matters/2020/09/pandemic-affect -survey-response.html. 
+5 Jonathan Rothbaum and Adam Bee, Coronavirus Infects Surveys Too: Nonresponse Bias During the Pandemic in the 
+
+Congressional Research Service 
+
+1 
+
+ 
+ Poverty in the United States in 2019 
+
+ 
+
+while poverty was indeed low in 2019, it was likely not as low as the official estimates suggest, 
+due to nonresponse bias. The information in this report necessarily uses the official estimates. 
+Detailed experimental estimates that adjust for nonresponse bias specific to the pandemic are not 
+
+available for the characteristics discussed in the report. 
+
+Bearing the above caveats in mind, in 2019 approximately 34 mil ion people had incomes below 
+the official definition of poverty in the United States, which was a decline from 38 mil ion people 
+in 2018. The poverty rate fel to 10.5% from 11.8%. This was the fifth consecutive year that the 
+poverty rate fel . The decline in poverty was broad based, affecting many demographic groups 
+
+and occurring in every region of the country (discussed below). 
+
+The numbers and percentages of those in poverty presented in this report are based on the Census 
+Bureau’s estimates.6 While this official measure is often regarded as a statistical yardstick rather 
+
+than a complete description of what people and families need to live,7 it does offer a measure of 
+economic hardship faced by the low-income population: the poverty measure compares family 
+income against a dollar amount cal ed a poverty threshold , a level below which the family is 
+considered to be poor. The Census Bureau releases these poverty estimates every September for 
+the prior calendar year. Most of the comparisons discussed in this report are year-to-year. The 
+
+report only considers a number or percentage to have changed from the previous year, or to be 
+different from another number or percentage, if the difference has been tested to be statistical y 
+
+significant at the 90% confidence level.8 
+
+Over the past several decades, criticisms of the official poverty measure have led to the 
+development of an alternative research measure cal ed the Supplemental Poverty Measure (SPM), 
+
+ 
+ CPS ASEC, U.S. Census Bureau, working paper number SEHSD WP2020 -10, September 2020, at 
+https://www.census.gov/library/working-papers/2020/demo/SEHSD-WP2020-10.html. 
+6 T he national-level data in this report were obtained from the report by Jessica Semega, Melissa Kollar, Emily A. 
+Shrider, and John Creamer, Incom e and Poverty in the United States: 2019, U.S. Census Bureau, Current Population 
+Reports number P60-270, September 15, 2020, at https://www.census.gov/library/publications/2020/demo/p60-
+270.html, and the detailed tabulations and the CPS ASEC public use file that accompanied the release of that report. 
+Details on the Supplemental Poverty Measure, also based primarily on the CPS ASEC, were obtained from Liana Fox, 
+ The Supplem ental Poverty Measure: 2019, U.S. Census Bureau, Current Population Reports number P60 -272, 
+September 15, 2020, at https://www.census.gov/library/publications/2020/demo/p60-272.html. State-level data in this 
+report were obtained from the 2019 American Community Survey (ACS), also conducted by the U.S. Census Bureau. 
+Details are available in Craig Benson, Poverty: 2018 and 2019, U.S. Census Bureau, ACS Brief number ACSBR/20-
+04, September 17, 2020, at https://www.census.gov/library/publications/2020/acs/acsbr20-04.html. 
+
+7 Jessica Semega, Melissa Kollar, Emily A. Shrider, and John Creamer, Income and Poverty in the United States: 2019, 
+U.S. Census Bureau, Current Population Reports number P60 -270, September 15, 2020, Appendix B, 
+https://www.census.gov/library/publications/2020/demo/p60-270.html. T he characterization of the poverty measure as a 
+statistical yardstick goes back decades. See, for example, “ U.S. Changes Yardstick on Who Is Poor,” Chicago Tribune , 
+May 3, 1965, section 1B, p. 4. 
+
+8 Not every apparent difference in point estimates is a real difference. T he official poverty measure uses information 
+from the CPS ASEC, which surveys about 95,000 addresses nationwide. All poverty data discussed here are t herefore 
+estimates, which have margins of error. Error in this case refers to a difference from the true data that is caused by 
+using a sample instead of the entire population, not mistakes in computation or biases from imperfect data collection or 
+processing. Even if a survey were implemented perfectly and had collected complete and accurate information from all 
+respondents in the sample, surveying a different sample would likely yield slightly different estimates of the poverty 
+population or the poverty rate. Thus, even if the true poverty rate were exactly the same in two different years, it is 
+possible to get survey estimates that appear different. In order to report that a change has occurred in the poverty rate —
+that is, that the difference between the estimates is likely not caused by sampling variability —the difference has to be 
+large enough that fewer than 10% of all possible survey samples would produce a difference that large (and, 
+conversely, 90% of the samples would not). Such a difference is said to be statistically significant at the 90% 
+confidence level. Point estimates whose differences are not statistically significant are described as such in this report . 
+
+Congressional Research Service 
+
+2 
+
+ 
+ Poverty in the United States in 2019 
+
+ 
+
+which the Census Bureau also computes and releases. Statistics comparing the official measure 
+
+with the SPM are provided at the conclusion of this report. 
+
+The SPM includes adjustments to reflect geographic variations in housing costs, and the 
+
+estimated effects of taxes and in-kind benefits (such as housing, energy, and food assistance) on 
+poverty, while the official measure does not. Because some types of tax credits and noncash 
+benefits provide financial help to families and individuals in poverty, the SPM may be of interest 
+to policymakers. However, the official measure provides a comparison of the poor population 
+over a longer period, including some years before many current antipoverty assistance programs 
+
+had been developed. In developing poverty-related legislation and conducting oversight on 
+programs that aid the low-income population, policymakers may be interested in these historical 
+
+trends. 
+
+ How the Official Poverty Measure is Computed 
+ The Census Bureau determines a person’s poverty status by comparing his or her resources 
+against a measure of need. For the official measure, resources is defined as total family income 
+before taxes, and the measure of need is a dollar amount cal ed a poverty threshold. There are 48 
+
+poverty thresholds that vary by family size and composition. If a person lives with other people to 
+whom he or she is related by birth, marriage, or adoption, the money income from al family 
+members is used to determine his or her poverty status. If a person does not live with any family 
+members, his or her own income is used. Only money income before taxes is used in calculating 
+the official poverty measure, meaning this measure does not treat in-kind benefits such as the 
+Supplemental Nutrition Assistance Program (SNAP, formerly known as food stamps), housing 
+
+subsidies, or employer-provided benefits as income. 
+
+The poverty threshold dollar amounts vary by the size of the family (from one person not living 
+
+in a family, to nine or more family members living together) and the ages of the family members 
+(how many of the members are children under 18 and whether or not the family head is 65 or 
+older). Collectively, these poverty thresholds are often referred to as the poverty line . As a rough 
+guide, the poverty line in 2019 can be thought of as $26,172 for a family of four, $20,335 for a 
+family of three, $16,521 for a family of two, or $13,011 for an individual not living in a family, 
+
+though the official measure is actual y much more detailed.9 
+
+The threshold dollar amounts are updated annual y for inflation using the Consumer Price Index. 
+Notably, the same thresholds are applied throughout the country: no adjustment is made for 
+
+geographic variations in living expenses.10 
+
+The official poverty measure used in this report is the federal government’s definition of poverty 
+for statistical purposes, such as comparing the number or percentage in poverty over time. A 
+
+related definition of poverty, the poverty guidelines published by the Department of Health and 
+
+ 
+9 T o provide a general sense of the poverty line , the Census Bureau computes weighted averages of the thresholds 
+within each family size. For example, a family of three may consist of any of the following combinations: three adults, 
+two adults and one child, or one adult and two children . Each combination has its own distinct threshold. T he $20,335 
+figure cited represents an average of those family combinations, adjusted to reflect that some types of three-person 
+families are more common than others. T he averages are a convenience for the reader, but are not actually used to 
+compute poverty status for statistical reports. In actual computations, 48 thresholds are used in the official measure . 
+
+10 Unlike the poverty thresholds that are used to compute official poverty statistics, the Health and Human Services 
+(HHS) poverty guidelines used for administrative purposes do include separate amounts for Alaska and Hawaii. 
+
+Congressional Research Service 
+
+3 
+
+ 
+ link to page 8 link to page 4 link to page 5 Poverty in the United States in 2019 
+
+ 
+
+Human Services (HHS), is used for administrative purposes such as eligibility criteria for 
+
+assistance programs and wil not be discussed in this report.11 
+
+ Historical Perspective 
+ Figure 1 shows a historical perspective of the number and percentage of the population below the 
+poverty line. The number in poverty and the poverty rates are shown from the earliest year 
+available (1959) through the most recent year available (2019). Because the total U.S. population 
+
+has grown over time, poverty rates are useful for historical comparisons because they control for 
+
+population growth. 
+
+Poverty rates fel through the 1960s. Since then, they have general y risen and fal en according to 
+
+the economic cycle, though during the two most recent expansions poverty rates did not fal 
+measurably until four to six years into the expansion. Historical y notable lows occurred in 1973 
+(11.1%), 2000 (11.3%), and 2019 (10.5%).12 Poverty rate peaks occurred in 1983 (15.2%), 1993 
+
+(15.1%), and 2010 (15.1%).13 
+
+Poverty rates tend to rise during and after recessions, as opposed to leading economic indicators 
+such as new housing construction, whose changes often precede changes in the performance of 
+the overal economy. The poverty rate’s lag is explainable in part by the way it is measured: it 
+
+uses income from the entire calendar year. 
+
+ 
+11 T he official poverty measure described in this report was established in the Office of Management and Budget’s 
+Statistical Policy Directive 14, May 1978, reproduced on the Census Bureau’s website at https://www.census.gov/
+topics/income-poverty/poverty/about/history-of-the-poverty-measure/omb-stat-policy-14.html. It states that the official 
+measure is to be used for statistical purposes, but should not be construed as required for administrative purposes. 
+T hough the poverty guidelines published by HHS use the official thresholds as part of their computation, the HHS 
+poverty guidelines are collectively a distinct poverty definition and are often used as a criterion in federal assistance 
+programs. T he HHS poverty guidelines are often referred to as the federal poverty level or FPL. See CRS Report 
+R44780, An Introduction to Poverty Measurem ent , for further discussion. 
+
+12 T he rate in 2019 is the lowest numerically, but suffered from nonresponse bias, as was described in the 
+ “Introduction ” section. Before 2019, the poverty rates in 1973 and 2000 had been considered to be tied for the lowest 
+measured poverty rate because they are not statistically different from each other. 
+13 T hese poverty rates may not necessarily be distinguishable from the poverty rates in their adjacent years. See 
+footnot e 8 for an explanation of statistical significance. 
+
+Congressional Research Service 
+
+4 
+
+ 
+ link to page 4 link to page 4 
+
+ Poverty in the United States in 2019 
+
+ 
+
+ Figure 1. Number of Persons in Poverty and Poverty Rate: 1959 to 2019 
+
+(Poverty rates in percentages, number of persons in mil ions. Shaded bars indicate recessions) 
+
+ 
+
+ Source: Congressional Research Service (CRS), based on poverty data from Table B-5 of Jessica Semega, 
+Melissa Kol ar, Emily A. Shrider, and John F. Creamer, Income and Poverty in the United States: 2019, U.S. Census 
+Bureau, Current Population Reports number P60-270, issued September 2020. 
+ Notes: The 2019 estimates were biased downward because of increased nonresponse associated with 
+telephone-only interviewing during the pandemic; for details, see the “Introduction” section. Two estimates are 
+shown for 2013 because the Census Bureau implemented a change to the CPS ASEC income questions. Some 
+households received the old questionnaire and others the new, so that it would be possible to see the effect of 
+changing the questionnaire. The CPS ASEC processing system was also updated for 2017. T hose updates did not 
+affect the overal poverty rate, nor the poverty rates for children or the population aged 18 -64, though the 2017 
+poverty rate for the aged was 0.3 percentage points higher than under the legacy system. For details, see John 
+Creamer and Ashley Edwards, Examining Poverty in 2016 and 2017 Using the Legacy and Updated Current Population 
+Survey Processing System, U.S. Census Bureau, Social, Economic, and Housing Statistics Division, Working Paper 
+#2019-28, July 30, 2019, https://www.census.gov/library/working-papers/2019/demo/SEHSD-WP2019-28.html. 
+
+ Poverty by Demographic Group 
+ Declines in poverty rates between 2018 and 2019 occurred among many demographic groups 
+rather than being concentrated among a few groups. Both sexes, multiple racial groups, children 
+and working-age adults, and full-time workers and nonworkers al experienced declines in their 
+poverty rates. Given the nonresponse bias explained in the “Introduction ” section, the discussion 
+below wil focus only on those groups with especial y large14 decreases in their poverty rates, to 
+
+avoid overstating how widely the decreases in poverty were felt. 
+
+ Family Structure 
+ Because poverty status is determined at the family level by comparing resources against a 
+measure of need, vulnerability to poverty may differ among families of different compositions. In 
+this section, poverty data by family structure are presented using the official poverty measure, 
+with families defined as persons related by birth, marriage, or adoption to the householder (the 
+
+ 
+14 For the purposes of this report, “especially large” refers to year-to-year decreases in poverty rates that would still be 
+statistically significant even if the decrease were half a percentage point less than actually reported by the Census 
+Bureau. 
+
+Congressional Research Service 
+
+5 
+
+ 
+ link to page 13 link to page 9 link to page 10 
+
+ Poverty in the United States in 2019 
+
+ 
+
+person in whose name the home is owned or rented). In the “Supplemental Poverty Measure ” 
+
+section of this report, a different definition wil be used. 
+
+In general, women have higher poverty rates than men: 11.5% compared with 9.4% in 2019. Both 
+
+sexes experienced poverty rate declines from 2018 (from 12.9% for women and 10.6% for men). 
+Historical y, families with a female householder and no spouse present (female-householder 
+families) have had higher poverty rates than both married-couple families and families with a 
+male householder and no spouse present (male-householder families). This remained true in 
+2019: the poverty rate among female-householder families was 22.2%, compared with 11.5% for 
+
+male-householder families and 4.0% for married-couple families ( Figure 2 ). 
+
+Female-householder families, unlike male-householder families, experienced a decline of 2.6 
+percentage points in their poverty rate from 2018. The 2019 poverty rate for female-householder 
+
+families was the lowest reported for that group. Even though nonresponse affected low -income 
+families more than high-income families, and female-householder families are more likely to be 
+low income than the other family types, the 2019 poverty rate is the latest in a series of low 
+
+poverty rates for this group, compared with previous decades. 
+
+Persons not living in families experienced a poverty rate decline as wel , from 20.2% in 2018 to 
+
+18.8% in 2019. 
+
+ Figure 2. Poverty Rates of Families by Family Structure: 2019 
+
+(Poverty rates in percentages) 
+
+ 
+
+ Source: Congressional Research Service (CRS), based on poverty data from Table B-2 of Jessica Semega, 
+Melissa Kol ar, Emily A. Shrider, and John F. Creamer, Income and Poverty in the United States: 2019, U.S. Census 
+Bureau, Current Population Reports number P60-270, issued September 2020. 
+ Notes: The poverty rates above include only families with a householder (the survey’s reference person for the 
+household; typical y the person in whose name the home is owned or rented). The Census Bureau defines a 
+family as those living together related by birth, marriage, or adoption. 
+
+ Age 
+ When examining poverty by age, the three main groups (under 18, 18 to 64, and 65 and older) are 
+noteworthy for distinct reasons. People under age 18 are typical y dependent on other family 
+
+members for income, particularly young children below their state’s legal working age. People 
+aged 18 to 64 are general y thought of as the working-age population and typical y have wages 
+and salaries as their greatest source of income. People aged 65 and older, referred to as the aged 
+population, are often eligible for retirement, and those who do retire typical y experience a 
+
+change in their primary source of income. 
+
+As shown i n Figure 3 , children and the working-age population experienced decreases in poverty. 
+Among children, 10.5 mil ion, or 14.4%, were poor, down from 11.9 mil ion, or 16.2%, in 2018. 
+
+Congressional Research Service 
+
+6 
+
+ 
+ link to page 4 link to page 11 
+
+ Poverty in the United States in 2019 
+
+ 
+
+Among the working-age population, 18.9 mil ion, or 9.4%, were in poverty, down from 21.1 
+
+mil ion, or 10.7%, in 2018. 
+
+In earlier years, the poverty rate for those aged 65 and over was the highest of the three age 
+
+groups. In 1966, people aged 65 and over had a poverty rate of 28.5%, compared with 17.6% for 
+those under 18 and 10.5% for working-age adults. By 1974, the poverty rate for people aged 65 
+and over had fal en to 14.6%, compared with 15.4% for people under 18 and 8.3% for working-
+age adults. Since then, people under 18 have had the highest poverty rate of the three groups, 
+
+while the poverty rate among the 65-and-older population had fal en to 8.9% by 2019. 
+
+ Figure 3. Poverty Rates by Age: 1959 to 2019 
+
+(Poverty rates in percentages. Shaded bars indicate recessions) 
+
+ 
+
+ Source: Congressional Research Service (CRS), based on poverty data from Table B-6 of Jessica Semega, 
+Melissa Kol ar, Emily A. Shrider, and John F. Creamer, Income and Poverty in the United States: 2019, U.S. Census 
+Bureau, Current Population Reports number P60-270, issued September 2020. 
+ Notes: The 2019 estimates were biased downward because of increased nonresponse associated with 
+telephone-only interviewing during the pandemic; for details, see the “Introduction” section. Data are not 
+available from 1960 to 1965 for persons aged 65 and older and for persons aged 18 to 64. Two estimates are 
+shown for 2013 for each age group because the Census Bureau implemented a change to the CPS ASEC income 
+questions. Some households received the old questionnaire and others the new, so that it would be possible to 
+see the effect of changing the questionnaire. The CPS ASEC processing system was also updated for 2017 . Those 
+updates did not affect the overal poverty rate, nor the poverty rates for children or the population aged 18 -64, 
+though the 2017 poverty rate for the aged was 0.3 percentage points higher than under the legacy system. For 
+details, see John Creamer and Ashley Edwards, Examining Poverty in 2016 and 2017 Using the Legacy and Updated 
+Current Population Survey Processing System, U.S. Census Bureau, Social, Economic, and Housing Statistics Division, 
+Working Paper #2019-28, July 30, 2019, https://www.census.gov/library/working-papers/2019/demo/SEHSD-
+WP2019-28.html. 
+
+ Race and Hispanic Origin15 
+ Poverty rates vary by race and Hispanic origin, as shown i n Figure 4 . In surveys, Hispanic origin 
+is asked about separately from race; accordingly, people identifying as Hispanic may be of any 
+
+ 
+15 Since 2002, federal surveys have asked respondents to identify with one or more races; previously, they could choose 
+only one. T he groups in this section represent those who identified with one race alone. Another approach is to include 
+those who selected each race group either alone or in combination with one or more other races. T hose data are also 
+
+Congressional Research Service 
+
+7 
+
+ 
+ 
+
+ Poverty in the United States in 2019 
+
+ 
+
+race. Among the racial and Hispanic origin groups with populations large enough to estimate 
+given the sample size of the CPS ASEC, every one experienced a statistical y significant decline 
+in its poverty rates from 2018 to 2019. Among the White non-Hispanic population, the poverty 
+rate fel from 8.1% to 7.3%; among the Black population,16 from 20.8% to 18.8%; among the 
+Asian population,17 from 10.1% to 7.3%; and among the Hispanic population, from 17.6% to 
+
+15.7%. 
+
+ Figure 4. Poverty Rates by Race and Hispanic Origin: 2019 
+
+(Poverty rates in percentages) 
+
+ 
+
+ Source: Congressional Research Service (CRS), based on poverty data from Table B-1 of Jessica Semega, 
+Melissa Kol ar, Emily A. Shrider, and John F. Creamer, Income and Poverty in the United States: 2019, U.S. Census 
+Bureau, Current Population Reports number P60-270, issued September 2020. 
+ Notes: People of Hispanic origin may be of any race. Additional y, respondents may identify with one or more 
+racial groups. Except for “Al persons” and “Hispanic,” the remaining groups shown include those who identified 
+with one race only. The “non-Hispanic White alone” group includes only the White non-Hispanic population, the 
+“Black alone” group includes Blacks of Hispanic origin, and the “Asian alone” group includes Asians of Hispanic 
+origin. Data for Native Hawai ans and Other Pacific Islanders, American Indians and Alaska Natives, and the 
+population of two or more races are not shown separately. 
+
+ Work Status 
+ While having a job reduced the likelihood of being in poverty, it did not guarantee that a person 
+or his or her family would avoid poverty. Among the population aged 18 to 64 living in poverty, 
+39.2% had jobs in 2019. Poverty rates among workers in this age group were 4.7% for al 
+workers, 2.0% for full-time year-round workers (down from 2.3% in 2018), and 12.0% for part-
+
+time or part-year workers. Among those who did not work at least one week in 2019, 26.4% were 
+
+poor (down from 29.7% in 2018). 
+
+Because poverty is a family-based measure, a change in one member’s work status can affect the 
+poverty status of his or her entire family. Among al 18- to 64-year-olds who did not have jobs in 
+2019, 61.4% lived in families in which someone else did have a job.18 Among 18- to 64-year-olds 
+
+ 
+available on the Census Bureau’s website at https://www.census.gov/library/publications/2020/demo/p60-270.html, 
+where they are published in Appendix B of Jessica Semega, Melissa Kollar, Emily A. Shrider, and John F. Creamer, 
+ Incom e and Poverty in the United States: 2019, U.S. Census Bureau, Current Population Reports number P60 -270, 
+issued September 2020; and in accompanying historical data tables. 
+16 Includes Blacks of Hispanic origin. 
+17 Includes Asians of Hispanic origin. 
+18 Author’s tabulation using 2020 CPS ASEC public use file. 
+
+Congressional Research Service 
+
+8 
+
+ 
+ link to page 13 Poverty in the United States in 2019 
+
+ 
+
+with income below the poverty line and without jobs, 19.2% lived in families where someone else 
+
+worked.19 
+
+ Poverty Rates by State20 
+ Poverty is not equal y prevalent in al parts of the countr y. Figure 5 shows states with relatively 
+high poverty rates across parts of the Appalachians, the Southwest, and the Deep South. 
+Mississippi’s poverty rate (19.6%), seemingly the highest, was not statistical y different from 
+
+Louisiana’s (19.0%). The poverty rate in New Hampshire (7.3%) was the lowest. When 
+comparing poverty rates geographical y, the official poverty thresholds are not adjusted for 
+geographic variations in the cost of living—the same thresholds are used nationwide. As such, an 
+area with a lower cost of living accompanied by lower wages wil appear to have a higher poverty 
+rate than an area with a higher cost of living and higher wages, even if individuals’ purchasing 
+
+power were exactly the same in both areas. 
+
+Twenty-three states and the District of Columbia experienced statistical y significant declines in 
+their poverty rates compared to 2018: three in the Northeast (Massachusetts, New York, and 
+
+Rhode Island), seven in the Midwest (Il inois, Indiana, Michigan, Minnesota, Nebraska, Ohio, 
+and Wisconsin), nine states (Alabama, Arkansas, Florida, Georgia, South Carolina, Tennessee, 
+Texas, Virginia, West Virginia) plus the District of Columbia in the South, and four in the West 
+
+(California, New Mexico, Oregon, and Washington). 
+
+ 
+19 Ibid. 
+20 T hese state estimates are based on the ACS instead of the CPS ASEC, because the Census Bureau recommends the 
+ACS when comparing states and smaller geographic areas. Because the CPS ASEC surveys 90,000 to 100,000 
+addresses nationwide, it is sometimes difficult to obtain reliable estimates for small populations or small geographic 
+areas—the sample may not have selected enough people from that group or area to provide a meaningful estimate. T he 
+ACS samples about 3.5 million addresses per year and therefore affords greater statistical precision for comparing 
+states and smaller geographic areas. However, unlike the CPS ASEC, which uses trained intervie wers and detailed 
+income questions, the ACS is filled out by the respondent on his or her own. Furthermore, the ACS is conducted 
+continuously, and asks the respondents about their income in the previous 12 months, not necessarily the previous 
+calendar year as in the CPS ASEC. For these reasons, poverty estimates from the ACS are often different from CPS 
+ASEC estimates: the ACS reported a poverty rate of 12.3% for the United States in 2019, compared with 10.5% in the 
+CPS ASEC (11.1% after adjusting for nonresponse bias resulting from telephone-only interviewing). Poverty estimates 
+from the ACS and the CPS ASEC do not include Puerto Rico in the U.S. total. Puerto Rico’s poverty rate was 43.5% in 
+2019. T he ACS is not conducted in the other U.S. territories. 
+
+Congressional Research Service 
+
+9 
+
+ 
+ link to page 12 
+
+ Poverty in the United States in 2019 
+
+ 
+
+ Figure 5. Percentage of People in Poverty in the Past 12 Months by State and for the 
+
+ District of Columbia and Puerto Rico: 2019 
+
+(Poverty rates in percentages) 
+
+ 
+
+ Source: Congressional Research Service, based on data from Craig Benson, Poverty: 2018 and 2019, U.S. Census 
+Bureau, American Community Survey Brief ACSBR/20-04, Table 1, issued September 2020, at 
+https://www.census.gov/library/publications/2020/acs/acsbr20-04.html. 
+ Notes: Data by state are based on the ACS while national-level data presented elsewhere in this report are 
+based on the CPS ASEC. The ACS reported a poverty rate of 12.3% for the United States in 2019, compared 
+with 10.5% in the CPS ASEC. See footnot e 20 for further details. 
+
+ Supplemental Poverty Measure 
+ Criticisms of the official poverty measure led to the development of the SPM. Described below 
+are the development of the official measure, its limitations, attempts to remedy those limitations, 
+the research efforts that eventual y led to the SPM’s first release in November 2011, and a 
+
+comparison of poverty rates in 2019 based on the SPM and the official measure.21 
+
+ How the Official Poverty Measure Was Developed 
+ The poverty thresholds were original y developed in the early 1960s by Mollie Orshansky of the 
+Social Security Administration. Rather than attempt to compute a family budget by using prices 
+
+for al essential items that low-income families need to live, Orshansky focused on food costs.22 
+
+ 
+21 For a more thorough discussion of the SPM’s development and methodology, see CRS Report R45031, The 
+Supplem ental Poverty Measure: Its Core Concepts, Developm ent, and Use . 
+
+22 While Orshansky did not attempt to compute a complete basket of goods and services, her focus on food costs was 
+already a more detailed empirical approach to poverty measurement than were the dollar amounts used in the 1964 
+Economic Report of the President, issued by the Council of Economic Advisers (chapter 2, “ T he Problem of Poverty in 
+America”). In that report, a flat figure of $3,000 was used for all families and $1,500 for unrelated individuals. See also 
+
+Congressional Research Service 
+
+10 
+
+ 
+ Poverty in the United States in 2019 
+
+ 
+
+Unlike other goods and services such as housing or transportation, which did not have a general y 
+agreed-upon level of adequacy, minimum standards for nutrition were known and widely 
+accepted. According to a 1955 U.S. Department of Agriculture (USDA) food consumption survey, 
+the average amount of their income that families spent on food was roughly one-third. Therefore, 
+using the cost of a minimum food budget and multiplying that figure by three yielded a figure for 
+total family income. That computation was possible because USDA had already published 
+
+recommended food budgets as a way to address the nutritional needs of families experiencing 
+economic stress. Some additional adjustments were made to derive poverty thresholds for two-
+person families and individuals not living in families to reflect the relatively higher fixed costs of 
+
+smal er households. 
+
+ Motivation for a Supplemental Measure 
+ While the official poverty measure has been used for over 50 years as the source of official 
+statistics on poverty in the United States, it has received criticism over the years for several 
+
+reasons. First, it does not take into account benefits from most of the largest programs that aid the 
+low-income population. For instance, it uses money income before taxes—meaning that it does 
+not necessarily measure the income available for individuals to spend, which for most people is 
+after-tax income. Therefore, any effects of tax credits designed to assist persons with low income 
+are not captured by the official measure. The focus on money income also does not account for 
+
+in-kind benefit programs designed to help the poor, such as SNAP or housing assistance. 
+
+The official measure has also been criticized for the way it characterizes families’ and 
+individuals’ needs in the poverty thresholds. That is, the method used to compute the dollar 
+
+amounts used in the thresholds, which were original y based on food expenditures in the 1950s 
+and food costs in the 1960s, does not accurately reflect current needs and available goods and 
+services.23 The official measure also does not take account of the sharing of expenses and income 
+among household members not related by birth, marriage, or adoption. And, as mentioned earlier, 
+
+the official thresholds do not take account of geographic variations in the cost of living. 
+
+In 1995, a panel from the National Academy of Sciences issued a report, Measuring Poverty: A 
+New Approach, which recommended improvements to the poverty measure.24 Among the 
+suggested improvements were to have the poverty thresholds reflect the costs of food, clothing, 
+
+shelter, utilities, and a little bit extra to al ow for miscel aneous needs; to broaden the definition of 
+ family ; to include geographic adjustments as part of the measure’s computation; to include the 
+out-of-pocket costs of medical expenses in the measure’s computation; and to subtract work-
+
+ 
+Economic Report of the President (1964), https://fraser.stlouisfed.org/title/45#8135. For a thorough history of the 
+official poverty measure, see Gordon Fisher, The Developm ent of the Orshansky Thresholds and Their Subsequent 
+History as the Official U.S. Poverty Measure, 1992, rev. 1997, reproduced on the Census Bureau’s website at 
+https://www.census.gov/library/working-papers/1997/demo/fisher-02.html. 
+23 Criticisms have been discussed in the mainstream press as well as academia. A 1988 article (Spencer Rich, “Drawing 
+the Line Between Rich, Poor,” The Washington Post , September 23, 1988, https://www.washingtonpost.com/archive/
+politics/1988/09/23/drawing-the-line-between-rich-poor/60f5dbeb-dab3-4a42-819a-2dea34e7854e/) documented 
+dissatisfaction about the official measure. T his came from both those claiming it was too high, citing its failure to 
+capture the effects of in-kind benefits for the poor and its overstatement of inflation, and those claiming it was too low, 
+based on the fact that if the thresholds were derived using more recent household consumption data, they would be 
+based on roughly five times the cost of food, not three times as Orshansky had computed in the early 1960s. 
+
+24 Constance F. Citro and Robert T . Michael, eds., Measuring Poverty: A New Approach, Panel on Poverty and Family 
+Assistance: Concepts, Information Needs, and Measurement Methods, Committee on National Statistics, National 
+Research Council (Washington, DC: National Academies Press, 1995), available at https://www.nap.edu/read/4759/
+chapter/1. 
+
+Congressional Research Service 
+
+11 
+
+ 
+ link to page 15 Poverty in the United States in 2019 
+
+ 
+
+related expenses from income. An overarching goal of the recommendations was to make the 
+poverty measure more closely aligned with the real-life needs and available resources of the low-
+income population, as wel as the changes that have taken place over time in their circumstances, 
+
+owing to changes in the nation’s economy, society, and public policies (se e Table 1 ). 
+
+After over a decade and a half of research to implement and refine the methodology suggested by 
+the panel, conducted both from within the Census Bureau as wel as by other federal agencies and 
+the academic community, the Census Bureau issued the first report using the SPM in November 
+
+2011.25 
+
+ Table 1. Differences Between the Official and Supplemental Poverty Measures 
+
+ 
+
+ Official Poverty Measure 
+
+ Supplemental Poverty Measure 
+
+ Resource 
+
+People related by birth, marriage, or adoption 
+
+People related by birth, marriage, adoption, plus 
+
+ units 
+
+(official Census Bureau definition of family ). 
+
+unrelated and foster children, and cohabiting partners 
+
+ ( families ) 
+
+People aged 15 and older not related to anyone 
+
+and their children or other relatives (if any) are 
+
+else in the household are considered as their 
+
+considered as “SPM resource units” (sharing resources 
+
+own economic units. 
+
+and expenses together). 
+
+ Needs 
+
+ Vary according to family size and ages of 
+
+ Vary according to the size and composition of the 
+
+ (thresholds) 
+
+family members. 
+
+resource unit (see above). 
+
+ Dol ar amounts based on the cost of a food 
+
+ Dol ar amounts based on consumer expenditure 
+
+plan for families in economic stress in the 
+
+data for food, clothing, shelter, and utilities, with 
+
+early 1960s, times three (with adjustments 
+
+adjustments by homeownership and mortgage or 
+
+for two-person families and individuals). 
+
+rental status. 
+
+ Updated for inflation using the Consumer 
+
+ Based on the most recent five years of consumer 
+
+Price Index. 
+
+expenditure data (not fixed at one point and trended 
+
+
+
+forward). 
+
+ No geographic cost adjustments. 
+
+ Housing costs geographical y adjusted for individual 
+
+metropolitan areas and the entire nonmetropolitan 
+area within states. 
+
+ Resources 
+
+Money income before taxes (includes 18 private 
+
+Money income (both private and government sources) 
+
+and government sources of income, including 
+
+ after taxes ... 
+
+Social Security, cash assistance, and other 
+
+ Minus: work expenses, child care expenses, child 
+
+sources of cash income). 
+
+support paid, out-of-pocket medical expenses. 
+
+ Plus: tax credits (such as the Child Tax Credit and 
+
+the Earned Income Tax Credit) and the value of in-
+kind benefits (such as food and housing subsidies). 
+
+ 
+25 T he effort to consolidate the previous research and create the SPM was done under the auspices of an Interagency 
+T echnical Working Group (IT WG) led by the Office of Management and Budget (OMB) and received public 
+commentary via a Federal Register notice ( Federal Register , vol. 75 no. 101, Wednesday, May 26, 2010, pp. 29513 -
+29514, https://www.federalregister.gov/documents/2010/05/26/2010-12628/developing-a-supplemental-poverty-
+measure). T he Federal Register notice referenced a report by the IT WG ("Observations from the Interagency Technical 
+Working Group on Developing a Supplemental Poverty Measure”), which has since been moved to a new URL at 
+https://www.census.gov/content/dam/Census/topics/income/supplemental-poverty-measure/spm-twgobservations.pdf. 
+T he comments that the Census Bureau received on that report are available on the Census Bureau’s website at 
+https://www.census.gov/content/dam/Census/topics/income/supplemental-poverty-measure/redactedcomments.pdf. 
+T hese and additional methodological documents on the SPM are available at https://www.census.gov/topics/income-
+poverty/supplemental-poverty-measure/guidance/methodology.html. 
+
+Congressional Research Service 
+
+12 
+
+ 
+ link to page 13 link to page 17 Poverty in the United States in 2019 
+
+ 
+
+ Source: Congressional Research Service (CRS) summary of methodological discussion in Liana Fox, The 
+Supplemental Poverty Measure: 2019, U.S. Census Bureau, September 2020, http://www.census.gov/content/dam/
+Census/library/publications/2020/demo/p60-272.pdf. 
+ Notes: For caveats, see the text of the “Supplemental Poverty Measure” section. 
+
+ Official and Supplemental Poverty Findings for 201926 
+ Compared with the official measure, the SPM takes into account greater detail of individuals’ and 
+
+families’ living arrangements and provides a more up-to-date accounting of the costs and 
+resources available to them. Because the SPM recognizes greater detail in relationships among 
+household members and geographical y adjusts housing costs, it provides an updated rendering, 
+compared with the official measure, of the circumstances in which the poor live. In that context, 
+some point out that the SPM’s measurement of taxes, transfers, and expenses may offer 
+
+policymakers a clearer view of how government policies affect the poor population today. 
+However, the SPM was developed as a research measure, and the Office of Management and 
+Budget set the expectation that it would be revised periodical y to incorporate improved 
+measurement methods and newer sources of data as they became available; it was not developed 
+for administrative purposes. The fact that tax liabilities and credits are modeled, or that in-kind 
+
+benefits are estimated using limited data, can be useful to bear in mind when comparing SPM 
+estimates with official poverty estimates, or when any changes to the SPM methodology become 
+implemented in the future.27 Conversely, the official measure’s consistency over a longer time 
+
+span makes it easier for policymakers and researchers to make historical comparisons. 
+
+Under the SPM, the profile of the poverty population is slightly different than under the official 
+measure. The SPM poverty rate was 1.3 percentage points higher (after rounding) in 2019 than 
+the official poverty rate (11.7%, compared with 10.5%; se e Figure 6 ).28 More people aged 18 to 
+64 were in poverty under the SPM (11.2%, compared with 9.4%), as were people aged 65 and 
+
+over (12.8%, compared with 8.9%). The poverty rate for people under age 18 was lower under the 
+SPM (12.5%) than under the official measure (14.4%, with foster children included). Again, the 
+SPM uses a different definition of resources than the official measure: the SPM includes in-kind 
+benefits and refundable tax credits that general y help families with children; subtracts out a flat 
+estimate of assumed work-related expenses, which are often incurred by the working-age 
+
+ 
+26 Data in this section are available in Liana Fox, The Supplemental Poverty Measure: 2019 , U.S. Census Bureau, 
+September 2020, Appendix T able 2, https://www.census.gov/library/publications/2020/demo/p60-272.html. 
+
+27 For instance, work expenses such as commuting costs can be difficult to pin down precisely for every person or 
+
+family, because they often influence and are influenced by a person’s or family’s decision about whe re to live. Rather 
+than attempting to estimate the relevant work expenses for every family, in the SPM a flat amount is assigned to 
+workers, multiplied by the number of weeks they worked. Some researchers have also found that the tax model used in 
+the SPM underestimates refundable tax credits, in comparison with administrative data, which particularly affects 
+families with children. T herefore, refinements to the SPM methodology based on the ongoing SPM research may not 
+be trivial. For a synopsis of the SPM methodology, see CRS Report R45031, The Supplem ental Poverty Measure: Its 
+Core Concepts, Developm ent, and Use . Working papers that present results of research into SPM methodology may be 
+found on the Census Bureau’s website at https://www.census.gov/topics/income-poverty/supplemental-poverty-
+measure/library/working-papers.html. 
+
+28 T o establish a more accurate comparison with the SPM, a set of poverty estimates using the official measure was 
+recomputed to include unrelated individuals under age 15 (such as foster children) who are not normally included in the 
+official measure. Additionally, both the SPM and the official poverty measure were affected by increased rates of 
+nonresponse in the 2020 CPS ASEC. After adjusting for the increase in nonresponse bias, the SPM poverty rate in 2019 
+was 11.9% compared with 11.1% for the official povert y rate. As with the estimates based on the official measure, the 
+SPM estimates discussed in this report will use the estimates as published, because adjusted estimates are not available 
+for the characteristics examined in the report. 
+
+Congressional Research Service 
+
+13 
+
+ 
+ 
+
+ Poverty in the United States in 2019 
+
+ 
+
+population; and subtracts medical out-of-pocket expenses, which are incurred frequently by 
+
+people aged 65 and older. 
+
+With the geographical y adjusted thresholds, the poverty rate in 2019 was lower under the SPM 
+
+than under the official measure for the Midwest (8.8% compared with 9.7%), while it was higher 
+than the official measure for the Northeast (11.7% compared with 9.4%), the West (13.2% 
+
+compared with 9.6%), and the South (12.4% compared with 12.0%). 
+
+ Figure 6. Poverty Rates Under Official Measure and Supplemental Poverty Measure 
+
+ for the United States, by Age and by Region: 2019 
+
+(Poverty rates in percentages) 
+
+ 
+
+ Source: Congressional Research Service, based on data from Liana Fox, The Supplemental Poverty Measure: 2019 , 
+U.S. Census Bureau, September 2020, Appendix Table 2, https://www.census.gov/library/publications/2020/demo/
+p60-272.html. 
+ Notes: Figures include unrelated individuals under age 15 (such as foster children), who are not usual y included 
+in official poverty estimates. 
+
+ 
+ 
+
+ Author Information 
+
+ 
+Joseph Dalaker 
+
+ 
+
+Analyst in Social Policy 
+ 
+
+Congressional Research Service 
+
+14 
+
+ 
+ Poverty in the United States in 2019 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan 
+shared staff to congressional committees and Members of Congress. It operates solely at the behest of and 
+under the direction of Congress. Information in a CRS Report should n ot be relied upon for purposes other 
+than public understanding of information that has been provided by CRS to Members of Congress in 
+connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not 
+subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in 
+its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or 
+material from a third party, you may need to obtain the permission of the copyright holder if you wish to 
+copy or otherwise use copyrighted material. 
+
+ 
+
+Congressional Research Service 
+
+R46759 · VERSION 1 · NEW 
+
+15
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+USDA Domestic Food Assistance Programs: FY2018 Appropriations
+
+ December 11, 2018
+ (R45433)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ Overview of FY2018 USDA-FNS Funding 
+
+ President's FY2018 Budget Request 
+
+ Domestic Food Assistance Appropriations Accounts and Related General Provisions 
+
+ Office of the Under Secretary for Food, Nutrition, and Consumer Services 
+
+ SNAP and Other Programs under the Food and Nutrition Act 
+
+ SNAP Account: Other General Provisions and Committee Report Language 
+
+ Child Nutrition Programs 
+
+ Child Nutrition Programs: General Provisions 
+
+ WIC Program 
+
+ Commodity Assistance Program 
+
+ Nutrition Programs Administration 
+
+ Other Nutrition Funding Support 
+
+ 
+ 
+ Figures
+
+ 
+ Figure 1. Scope of Agriculture and Related Agencies Appropriations 
+
+ 
+ 
+
+ 
+ Tables
+
+ 
+ Table 1. Domestic Food Assistance Appropriations, P.L. 115-141 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ The Consolidated Appropriations Act, 2018 ( P.L. 115-141 ) was enacted on March 23, 2018. This omnibus bill included appropriations for the U.S. Department of Agriculture (USDA), of which USDA's domestic food assistance programs are a part. Prior to its enactment, the federal government had continued to operate for the first six months of the fiscal year under continuing resolutions (CRs). This report focuses on the enacted appropriations for USDA's domestic food assistance programs and, in some instances, policy changes provided by the omnibus law. CRS Report R45128, Agriculture and Related Agencies: FY2018 Appropriations provides an overview of the entire FY2018 Agriculture and Related Agencies portion of the law as well as a review of the reported bills and CRs preceding it.
+
+ Domestic food assistance funding is primarily mandatory but also includes discretionary funding. Most of the programs' funding is for open-ended, appropriated mandatory spending—that is, terms of the authorizing law require full funding and funding may vary with program participation (and in some cases inflation). The largest mandatory programs include the Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp Program) and the child nutrition programs (including the National School Lunch Program and School Breakfast Program). Though their funding levels are dictated by the authorizing law, in most cases, appropriations are needed to make funds available for obligation and expenditure. The three largest discretionary budget items are the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); the Commodity Supplemental Food Program (CSFP); and federal nutrition program administration. 
+
+ The domestic food assistance funding is, for the most part, administered by USDA's Food and Nutrition Service (FNS). The enacted FY2018 appropriation provides nearly $105 billion for domestic food assistance ( Table 1 ). This is a decrease of approximately $3.2 billion from FY2017. Declining participation in SNAP is responsible for most of the difference. Over 95% of the FY2018 appropriations for domestic food assistance are for mandatory spending. Highlights of the associated appropriations accounts are summarized below.
+
+ For SNAP and other programs authorized by the Food and Nutrition Act, such as The Emergency Food Assistance Program (TEFAP) commodities, the FY2018 appropriations law provides approximately $74.0 billion. Certain provisions of the law affect SNAP policies. For example, it continues a policy in the FY2017 appropriations law that limited USDA's implementation of December 2016 regulations regarding SNAP retailers' inventory requirements. USDA must amend its final rule to define "variety" more expansively and must "apply the requirements regarding acceptable varieties and breadth of stock."
+
+ For the child nutrition programs (National School Lunch Program and others), the enacted law provides approximately $24.3 billion. This includes discretionary funding for school meals equipment grants ($30 million) and Summer Electronic Benefit Transfer (EBT) demonstration projects ($28 million). General provisions provide an additional $5 million for farm-to-school grants and $2 million for training school nutrition personnel. The law includes policy provisions related to processed poultry from China, discrimination in the school meals programs, and requirements for schools' paid lunch pricing.
+
+ For the WIC program, the law provides nearly $6.2 billion while also rescinding $800 million in prior-year carryover funding.
+
+ For the Commodity Assistance Program account, which includes funding for the Commodity Supplemental Food Program, TEFAP administrative and distribution costs, and other programs, the law provides over $322 million. It provides level funding for the WIC Farmers' Market Nutrition Program ($18.5 million), though the President's budget requested no funding for this program.
+
+ For Nutrition Programs Administration, the law provides nearly $154 million.
+
+ 
+ 
+ 
+
+ T he Consolidated Appropriations Act, 2018 ( P.L. 115-141 ) was enacted on March 23, 2018. This omnibus bill included appropriations for the U.S. Department of Agriculture (USDA), of which USDA's domestic food assistance is a part. Prior to its enactment, the government had continued to operate for the first six months of the fiscal year under continuing resolutions (CRs). 
+
+ This report focuses on USDA's domestic food assistance programs; their funding; and, in some instances, policy changes provided by the enacted FY2018 appropriations law. USDA's domestic food assistance programs include the Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp Program), Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and the child nutrition programs (such as the National School Lunch Program). The domestic food assistance funding is, for the most part, administered by USDA's Food and Nutrition Service (FNS). 1 CRS Report R45128, Agriculture and Related Agencies: FY2018 Appropriations provides an overview of the entire FY2018 Agriculture and Related Agencies appropriations law as well as a review of the reported bills and CRs preceding its enactment.
+
+ With its focus on appropriations, this report discusses programs' eligibility requirements and operations minimally. See CRS Report R42353, Domestic Food Assistance: Summary of Programs for more background.
+
+ 
+ 
+ 
+ 
+ Supplemental Funding for FNS Programs' Disaster Response 
+
+ Provided by Other Laws During FY2018
+
+ During FY2018, before the omnibus bill was enacted, certain FNS programs received supplemental funding to respond to 2017 natural disasters: 2 
+ P.L. 115-72 (§309) provided for usage of previously appropriated SNAP contingency reserve funds as a grant to support Puerto Rico's "disaster nutrition assistance" through the end of FY2019.
+
+ P.L. 115-123 , the Bipartisan Budget Act of 2018, provided $24 million for The Emergency Food Assistance Program (TEFAP) commodities and administrative costs, specifically for those jurisdictions that received a major disaster or emergency declaration related to the consequences of hurricanes Harvey, Irma, and Maria or due to wildfires in 2017.
+
+ P.L. 115-123 provided $14 million for WIC infrastructure grants for Puerto Rico and the U.S. Virgin Islands for "repair and restoration of buildings, equipment, technology, and other infrastructure damages as a consequence of Hurricanes Irma and Maria."
+ 
+ 
+ 
+ 
+
+ Overview of FY2018 USDA-FNS Funding 
+
+ Domestic food assistance—SNAP and child nutrition programs in the mandatory spending accounts, and WIC and other programs in the discretionary spending accounts—represents over two-thirds of the FY2018 Agriculture appropriations act ( Figure 1 ). 
+
+ The federal budget process treats discretionary and mandatory spending differently. 3 
+ Discretionary spending is controlled by annual appropriations acts and receives most of the attention during the appropriations process. The annual budget resolution 4 process sets spending limits for discretionary appropriations. Agency operations (salaries and expenses) and many grant programs are discretionary.
+
+ Mandatory spending —though carried in the appropriation—is controlled by budget rules during the authorization process. 5 Appropriations acts then provide funding to match the parameters required by the mandatory programs' authorizing laws. For the domestic food assistance programs, these laws are typically reauthorized in farm bill 6 and child nutrition reauthorizations. 7 
+ 
+ 
+ 
+ 
+ 
+ Figure 1. Scope of Agriculture and Related Agencies Appropriations
+
+ FY2018 budget authority total: $145.6 billion
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: Congressional Research Service (CRS) (see CRS Report R45128, Agriculture and Related Agencies: FY2018 Appropriations ). Does not show some agencies under $0.5 billion. Includes General Provisions with agency.
+
+ Notes: SNAP = Supplemental Nutrition Assistance Program; CCC = Commodity Credit Corporation; FCIC = Federal Crop Insurance Corporation; Section 32 = Funds for Strengthening Markets, Income and Supply; WIC = Special Supplemental Nutrition Program for Women, Infants, and Children; CSFP = Commodity Supplemental Food Program.
+
+ 
+ 
+ 
+ 
+
+ Domestic food assistance funding ( Table 1 ) largely consists of open-ended, appropriated mandatory programs—that is, it varies with program participation (and in some cases inflation) under the terms of the underlying authorization law. The largest mandatory programs include SNAP and the child nutrition programs (including the National School Lunch Program and School Breakfast Program). Though their funding levels are dictated by the authorizing law, in most cases appropriations are needed to make funds available.
+
+ The three largest discretionary budget items are WIC, the Commodity Supplemental Food Program (CSFP), and federal nutrition program administration.
+
+ The enacted FY2018 appropriation would provide nearly $105 billion for domestic food assistance ( Table 1 ). This is a decrease of approximately $3.2 billion from FY2017. Declining participation in SNAP is responsible for most of the difference. Over 95% of the FY2018 appropriations are for mandatory spending.
+
+ Table 1 summarizes funding for the domestic food assistance programs, comparing FY2018 levels to those of prior years. In addition to the accounts' appropriations language, the enacted appropriation's general provisions include additional funding, rescissions, and/or policy changes. These are summarized in this report. 
+
+ 
+
+ 
+
+ 
+ 
+ Table 1. Domestic Food Assistance Appropriations, P.L. 115-141
+
+ (Budget authority in millions of dollars)
+
+ 
+
+ 
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ FY2018
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Program
+
+ 
+ 
+ Mand. (M) or Disc. (D)
+
+ 
+ 
+ P.L. 113-235 
+
+ 
+ 
+ P.L. 114-113 
+
+ 
+ 
+ P.L. 115-31 
+
+ 
+ 
+ Admin. Request a 
+
+ 
+ 
+ H. Cmte. H.R. 3268 
+
+ 
+ 
+ S. Cmte. S. 1603 
+
+ 
+ 
+ Enacted P.L. 115-141 
+
+ 
+ 
+ Change: 
+FY2017 to FY2018 Enacted
+
+ 
+ 
+ 
+ 
+ Child Nutrition Programs b 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Account Total c (including transfers) 
+
+ 
+ Â 
+
+ 
+ 
+ 21,300.2 
+
+ 
+ 
+ 22,149.7 
+
+ 
+ 
+ 22,794.0 
+
+ 
+ 
+ 24,256.3 
+
+ 
+ 
+ 24,280.9 
+
+ 
+ 
+ 24,296.5 
+
+ 
+ 
+ 24,254.1 
+
+ 
+ 
+ +1,460.1 
+
+ 
+ 
+ +6.4% 
+
+ 
+ 
+ 
+ 
+ National School Lunch Program 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 11,996.1 
+
+ 
+ 
+ 12,154.7 
+
+ 
+ 
+ 12,339.8 
+
+ 
+ 
+ 13,010.1 
+
+ 
+ 
+ 13,010.1 
+
+ 
+ 
+ 13,010.1 
+
+ 
+ 
+ 13,133.2 
+
+ 
+ 
+ +793.4 
+
+ 
+ 
+ +6.4% 
+
+ 
+ 
+ 
+ 
+ School Breakfast Program 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 3,960.0 
+
+ 
+ 
+ 4,338.6 
+
+ 
+ 
+ 4,470.2 
+
+ 
+ 
+ 4,775.6 
+
+ 
+ 
+ 4,775.6 
+
+ 
+ 
+ 4,775.6 
+
+ 
+ 
+ 4,807.4 
+
+ 
+ 
+ +337.2 
+
+ 
+ 
+ +7.5% 
+
+ 
+ 
+ 
+ 
+ Child and Adult Care Food Program 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 3,195.9 
+
+ 
+ 
+ 3,340.1 
+
+ 
+ 
+ 3,490.9 
+
+ 
+ 
+ 3,919.4 
+
+ 
+ 
+ 3,919.4 
+
+ 
+ 
+ 3,919.4 
+
+ 
+ 
+ 3,832.7 
+
+ 
+ 
+ +341.8 
+
+ 
+ 
+ +9.8% 
+
+ 
+ 
+ 
+ 
+ Special Milk Program 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 11.2 
+
+ 
+ 
+ 9.4 
+
+ 
+ 
+ 9.2 
+
+ 
+ 
+ 8.8 
+
+ 
+ 
+ 8.8 
+
+ 
+ 
+ 8.8 
+
+ 
+ 
+ 8.8 
+
+ 
+ 
+ -0.4 
+
+ 
+ 
+ -4.3% 
+
+ 
+ 
+ 
+ 
+ Summer Food Service Program 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 495.5 
+
+ 
+ 
+ 555.7 
+
+ 
+ 
+ 627.1 
+
+ 
+ 
+ 639.8 
+
+ 
+ 
+ 639.8 
+
+ 
+ 
+ 639.8 
+
+ 
+ 
+ 563.8 
+
+ 
+ 
+ -63.3 
+
+ 
+ 
+ -10.1% 
+
+ 
+ 
+ 
+ 
+ State Administrative Expenses 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 263.7 
+
+ 
+ 
+ 270.9 
+
+ 
+ 
+ 279.1 
+
+ 
+ 
+ 299.1 
+
+ 
+ 
+ 299.1 
+
+ 
+ 
+ 299.1 
+
+ 
+ 
+ 297.3 
+
+ 
+ 
+ +18.2 
+
+ 
+ 
+ +6.5% 
+
+ 
+ 
+ 
+ 
+ Commodity Procurement for Child Nutrition 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 1,255.5 
+
+ 
+ 
+ 1,350.7 
+
+ 
+ 
+ 1,428.1 
+
+ 
+ 
+ 1,489.3 
+
+ 
+ 
+ 1,489.3 
+
+ 
+ 
+ 1,489.3 
+
+ 
+ 
+ 1,461.8 
+
+ 
+ 
+ +33.7 
+
+ 
+ 
+ +2.4% 
+
+ 
+ 
+ 
+ 
+ School Meals Equipment, Breakfast Grants 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 25.0 
+
+ 
+ 
+ 30.0 d 
+
+ 
+ 
+ 25.0 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 25.0 
+
+ 
+ 
+ 30.0 
+
+ 
+ 
+ 30.0 
+
+ 
+ 
+ +5.0 
+
+ 
+ 
+ +20.0% 
+
+ 
+ 
+ 
+ 
+ Summer EBT Demonstration 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 16.0 
+
+ 
+ 
+ 23.0 d 
+
+ 
+ 
+ 23.0 
+
+ 
+ 
+ 23.0 
+
+ 
+ 
+ 23.0 
+
+ 
+ 
+ 23.0 
+
+ 
+ 
+ 28.0 
+
+ 
+ 
+ +5.0 
+
+ 
+ 
+ +21.7% 
+
+ 
+ 
+ 
+ 
+ Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 6,623.0 
+
+ 
+ 
+ 6,350.0 e 
+
+ 
+ 
+ 6,350.0 f 
+
+ 
+ 
+ 6,150.0 g 
+
+ 
+ 
+ 6,350.0 h 
+
+ 
+ 
+ 6,350.0 h 
+
+ 
+ 
+ 6,175.0 h 
+
+ 
+ 
+ -175.0 
+
+ 
+ 
+ -2.8% 
+
+ 
+ 
+ 
+ 
+ Supplemental Nutrition Assistance Program (SNAP) b 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Account Total c 
+
+ 
+ Â 
+
+ 
+ 
+ 81,837.6 
+
+ 
+ 
+ 80,849.4 
+
+ 
+ 
+ 78,480.7 
+
+ 
+ 
+ 73,612.5 i 
+
+ 
+ 
+ 79,673.3 
+
+ 
+ 
+ 79,682.2 
+
+ 
+ 
+ 74,013.5 
+
+ 
+ 
+ -4,467.2 
+
+ 
+ 
+ -5.5% 
+
+ 
+ 
+ 
+ 
+ SNAP B enefits 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 71,035.8 
+
+ 
+ 
+ 70,124.3 
+
+ 
+ 
+ 67,754.4 
+
+ 
+ 
+ 62,639.3 
+
+ 
+ 
+ 68,801.1 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 63,039.0 
+
+ 
+ 
+ -4,715.4 
+
+ 
+ 
+ -6.7% 
+
+ 
+ 
+ 
+ 
+ Contingency Reserve Fund 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 3,000.0 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 0.0% 
+
+ 
+ 
+ 
+ 
+ State Administrative Costs 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 4,123.0 
+
+ 
+ 
+ 4,222.0 
+
+ 
+ 
+ 4,230.5 
+
+ 
+ 
+ 4,483.4 
+
+ 
+ 
+ 4,348.6 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 4,483.4 
+
+ 
+ 
+ +252.9 
+
+ 
+ 
+ +6.0% 
+
+ 
+ 
+ 
+ 
+ Employment and Training (E&T) 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 447.2 j 
+
+ 
+ 
+ 455.7 
+
+ 
+ 
+ 456.0 
+
+ 
+ 
+ 476.7 
+
+ 
+ 
+ 465.7 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 476.7 
+
+ 
+ 
+ +20.7 
+
+ 
+ 
+ +4.5% 
+
+ 
+ 
+ 
+ 
+ Nutrition Education and Obesity Prevention 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 407.0 
+
+ 
+ 
+ 408.0 
+
+ 
+ 
+ 414.0 
+
+ 
+ 
+ 421.0 
+
+ 
+ 
+ 414.0 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 421.0 
+
+ 
+ 
+ +7.0 
+
+ 
+ 
+ +1.7% 
+
+ 
+ 
+ 
+ 
+ TEFAP Commodities 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 327.0 
+
+ 
+ 
+ 318.0 
+
+ 
+ 
+ 316.0 k 
+
+ 
+ 
+ 288.8 
+
+ 
+ 
+ 288.8 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 289.5 
+
+ 
+ 
+ -26.5 
+
+ 
+ 
+ -8.3% 
+
+ 
+ 
+ 
+ 
+ Food Distribution Program on Indian Reservations 
+
+ 
+ 
+ M l 
+
+ 
+ 
+ 145.2 
+
+ 
+ 
+ 145.2 
+
+ 
+ 
+ 151.0 
+
+ 
+ 
+ 153.0 
+
+ 
+ 
+ 153.0 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 153.0 
+
+ 
+ 
+ +2.0 
+
+ 
+ 
+ +1.4% 
+
+ 
+ 
+ 
+ 
+ Commonwealth of Northern Mariana Islands 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 12.2 
+
+ 
+ 
+ 12.2 
+
+ 
+ 
+ 12.2 
+
+ 
+ 
+ 12.1 
+
+ 
+ 
+ 12.1 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 12.1 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 0.0% 
+
+ 
+ 
+ 
+ 
+ Puerto Rico and American Samoa 
+
+ 
+ 
+ M 
+
+ 
+ 
+ 2,030.3 
+
+ 
+ 
+ 1,967.0 
+
+ 
+ 
+ 1,956.9 
+
+ 
+ 
+ 1,936.7 
+
+ 
+ 
+ 1,936.7 
+
+ 
+ 
+ n/a 
+
+ 
+ 
+ 1,937.4 
+
+ 
+ 
+ -19.5 
+
+ 
+ 
+ -1.0% 
+
+ 
+ 
+ 
+ 
+ Commodity Assistance Program 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Account Total c 
+
+ 
+ Â 
+
+ 
+ 
+ 278.5 
+
+ 
+ 
+ 296.2 
+
+ 
+ 
+ 315.1 
+
+ 
+ 
+ 293.6 
+
+ 
+ 
+ 317.1 
+
+ 
+ 
+ 317.1 
+
+ 
+ 
+ 322.1 
+
+ 
+ 
+ +7.0 
+
+ 
+ 
+ +2.4% 
+
+ 
+ 
+ 
+ 
+ Commodity Supplemental Food Program 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 211.5 
+
+ 
+ 
+ 222.2 
+
+ 
+ 
+ 236.1 
+
+ 
+ 
+ 238.1 
+
+ 
+ 
+ 238.1 
+
+ 
+ 
+ 238.1 
+
+ 
+ 
+ 238.1 
+
+ 
+ 
+ +2.0 
+
+ 
+ 
+ +0.9% 
+
+ 
+ 
+ 
+ 
+ WIC Farmers' Market Nutrition Program 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 16.5 
+
+ 
+ 
+ 18.5 
+
+ 
+ 
+ 18.5 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 18.5 
+
+ 
+ 
+ 18.5 
+
+ 
+ 
+ 18.5 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 0.0% 
+
+ 
+ 
+ 
+ 
+ TEFAP Administrative Costs 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 49.4 
+
+ 
+ 
+ 54.4 
+
+ 
+ 
+ 59.4 
+
+ 
+ 
+ 54.4 
+
+ 
+ 
+ 59.4 
+
+ 
+ 
+ 59.4 
+
+ 
+ 
+ 64.4 
+
+ 
+ 
+ +5.0 
+
+ 
+ 
+ +9.2% 
+
+ 
+ 
+ 
+ 
+ Nutrition Program Administration 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 150.8 
+
+ 
+ 
+ 150.8 
+
+ 
+ 
+ 170.7 
+
+ 
+ 
+ 148.5 
+
+ 
+ 
+ 148.5 
+
+ 
+ 
+ 153.8 
+
+ 
+ 
+ 153.8 
+
+ 
+ 
+ -16.9 
+
+ 
+ 
+ -11.2% 
+
+ 
+ 
+ 
+ 
+ Office of the Under Secretary 
+
+ 
+ 
+ D 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.8 
+
+ 
+ 
+ 0.0 
+
+ 
+ 
+ 0.0% 
+
+ 
+ 
+ 
+ 
+ Total, Domestic Food Assistance 
+ (Title IV) m 
+
+ 
+ Â 
+
+ 
+ 
+ 110,190.9 
+
+ 
+ 
+ 109,797.0 
+
+ 
+ 
+ 108,111.3 
+
+ 
+ 
+ 104,461.7 
+
+ 
+ 
+ 104,507.4 
+
+ 
+ 
+ 104,730.8 
+
+ 
+ 
+ 104,919.4 
+
+ 
+ 
+ -3,191.9 
+
+ 
+ 
+ -2.9% 
+
+ 
+ 
+ 
+ 
+ Source: CRS, compiled from tables in the joint explanatory statements or committee reports for the referenced appropriations acts or bills. 
+
+ a. The FY2018 Administration request reflected in this column is from the FNS budget request submitted to Congress in February 2018. 
+
+ b. FNS programs that are open-ended mandatory programs (e.g., SNAP and the child nutrition programs), the programs do not necessarily have the authority to spend all of the appropriated funds. For such programs' historical spending, see also FNS expenditure data at http://www.fns.usda.gov/ data-and-statistics . 
+
+ c. "Account Total" includes amounts for the programs listed below as well as other programs not listed. 
+
+ d. FY2016 figures include additional funds from the general provisions (§741) of the enacted law: $5 million for equipment/breakfast grants; $7 million for Summer EBT.
+
+ e. The FY2016 law's Section 751 provided $220 million for management information systems and WIC EBT by rescinding FY2015 carryover and recovery funding. 
+
+ f. The FY2017 enacted law (§745) rescinded $850 million in WIC carryover funds. 
+
+ g. The Administration also requested a rescission of $1.0 billion in WIC carryover funding. 
+
+ h. The enacted law also rescinds $800 million in WIC carryover funding. Both reported bills would also have rescinded carryover funds: H.R. 3268 (§741) would have rescinded $600 million; S. 1603 (§741) would have rescinded $800 million. 
+
+ i. This is the Administration's FY2018 SNAP request for current law. The Administration also proposed eight SNAP legislative proposals. If these proposals were enacted, the Administration estimated it would reduce the SNAP request by approximately $4.9 billion (a request of $68.7 billion for the account). 
+
+ j. In addition to this E&T funding, P.L. 113-235 also appropriates $190 million for E&T pilots. The 2014 farm bill provided the authorization for this mandatory funding. For further information, see CRS Report R43332, SNAP and Related Nutrition Provisions of the 2014 Farm Bill (P.L. 113-79) .
+
+ k. The enacted FY2017 law provides $297 million required by the Food and Nutrition Act and an additional $19 million for TEFAP commodities provided in general provisions (§748). 
+
+ l. A portion of FDPIR funding (nutrition education) is discretionary. 
+
+ m. Title IV totals do not include additions and rescissions provided in bills' general provisions.
+
+ 
+
+ 
+
+ 
+
+ President's FY2018 Budget Request
+
+ Table 1 compares the enacted funding to the House- and Senate-reported bills, prior years' enacted funding, and the President's FY2018 budget request. The President's budget request includes the Administration's forecast for programs with open-ended funding such as SNAP and the child nutrition programs; this assists the appropriations committees in providing funding levels expected to meet obligations. The budget also includes the Administration's requests for discretionary programs. Additionally, it is a place for the Administration to include legislative requests. The FY2018 request did include SNAP legislative proposals.
+
+ Most significantly for the FNS programs, the President's FY2018 budget request did the following: 
+ It included eight legislative proposals pertaining to SNAP. 8 The majority of these would have restricted SNAP eligibility and made changes to the benefit calculation. The request also proposed to require states to share the cost of SNAP benefits and to require retailers applying to accept SNAP benefits to pay a fee. Together, these proposals were estimated by both the Administration and Congressional Budget Office (CBO) to reduce program spending in FY2018 and over the 10-year budget window. 9 None of these policies were enacted as part of the FY2018 appropriation. Related policies were debated in the formulation of the 2018 farm bill. 10 
+
+ It requested no funding for the WIC Farmers' Market Nutrition Program, a program that had received consistent discretionary funding in past years (see " Commodity Assistance Program ").
+ Domestic Food Assistance Appropriations Accounts and Related General Provisions
+
+ Office of the Under Secretary for Food, Nutrition, and Consumer Services
+
+ For the Under Secretary's office, the enacted FY2018 appropriation provides approximately $0.8 million. This office received approximately equal funding in FY2017.
+
+ The enacted appropriation (§740) continues to require the coordination of FNS research efforts with USDA's Research, Education and Economics mission area. This is to include a research and evaluation plan submitted to Congress.
+
+ Section 750 of the enacted appropriation prohibits state Electronic Benefit Transfer (EBT) contractors and subcontractors from charging fees for switching or routing USDA benefit transactions. All states use EBT systems for SNAP, and most use them for WIC. The provision defines switching fees as "the routing of an intrastate or interstate transaction that consists of transmitting the details of a transaction electronically recorded through the use of an electronic benefit transfer card in one State to the issuer of the card that may be in the same or different state." In the past, these fees have at times been charged to retailers and/or those routing transactions on behalf of retailers, increasing these entities' costs. The prohibition is in place from the date of enactment through the end of FY2019. 
+
+ SNAP and Other Programs under the Food and Nutrition Act
+
+ Appropriations under the Food and Nutrition Act (formerly the Food Stamp Act) support (1) SNAP (and related grants); (2) a nutrition assistance block grant for Puerto Rico and nutrition assistance block grants to American Samoa and the Commonwealth of the Northern Mariana Islands (all in lieu of SNAP); (3) the cost of food commodities as well as administrative and distribution expenses under the Food Distribution Program on Indian Reservations (FDPIR); (4) the cost of commodities for TEFAP, but not administrative/distribution expenses, which are covered under the Commodity Assistance Program budget account; and (5) Community Food Projects. 
+
+ The enacted appropriation provides approximately $74.0 billion for programs under the Food and Nutrition Act. This FY2018 level is approximately $3.2 billion less than FY2017 appropriations. This difference is largely due to a forecasted reduction in SNAP participation. 11 The enacted appropriation provides $3 billion for the SNAP contingency reserve fund. 12 
+
+ The SNAP account also includes mandatory funding for TEFAP commodities. The enacted appropriation provides nearly $290 million, according to the terms of the Food and Nutrition Act. This is less funding (-$26.5 million, -8.3%) than the $316.0 million provided in FY2017. (TEFAP also receives discretionary funding for storage and distribution costs, as discussed later in " Commodity Assistance Program .")
+
+ SNAP Account: Other General Provisions and Committee Report Language
+
+ SNAP-Authorized Retailers. The FY2017 appropriations law limited USDA's implementation of December 2016 regulations regarding SNAP retailers' inventory requirements, and the enacted FY2018 appropriation (§728) continues those limits. 
+
+ Only SNAP-authorized retailers may accept SNAP benefits. On December 15, 2016, FNS published a final rule to change retailer requirements for SNAP authorization. 13 The final rule would have implemented the 2014 farm bill's changes to inventory requirements for SNAP-authorized retailers ( P.L. 113-79 , §4002). Namely, the 2014 farm bill increased both the varieties of "staple foods" and the perishable items within those varieties that SNAP retailers must stock. In addition to codifying the farm bill's changes, the final rule would have changed how staple foods are defined, clarified limitations on retailers' sale of hot foods, and increased the minimum number of stocking units. 14 
+
+ Section 728 in the enacted appropriation continues to require that USDA amend its final rule to define "variety" more expansively and that USDA "apply the requirements regarding acceptable varieties and breadth of stock" that were in place prior to P.L. 113-79 until such regulatory amendments are made. In the meantime, USDA-FNS has implemented other aspects of the final rule, such as increased stocking units. 15 
+
+ Child Nutrition Programs 16 
+
+ Appropriations under the child nutrition account fund a number of programs and activities authorized by the Richard B. Russell National School Lunch Act and the Child Nutrition Act. These include the National School Lunch Program (NSLP), School Breakfast Program (SBP), Child and Adult Care Food Program (CACFP), Summer Food Service Program (SFSP), Special Milk Program (SMP), assistance for state administrative expenses, procurement of commodities (in addition to transfers from separate budget accounts within USDA), state-federal reviews of the integrity of school meal operations ("Administrative Reviews"), "Team Nutrition" and education initiatives to improve meal quality and food safety, and support activities such as technical assistance to providers and studies/evaluations. (Child nutrition efforts are also supported by permanent mandatory appropriations and other funding sources discussed in the section " Other Nutrition Funding Support .")
+
+ The enacted FY2018 appropriation provides approximately $24.3 billion for child nutrition programs. This is approximately $1.5 billion more (+6.4%) than the amount provided in FY2017, and reflects a transfer of over $8.9 billion from the Section 32 account. 
+
+ The enacted appropriation funds certain child nutrition discretionary grants. These include the following: 
+ School Meals Equipment Grants. 17 The law provides $30 million, $5 million more than was provided in FY2017. 
+
+ Summer EBT (Electronic Benefit Transfer) Demonstration Projects. These projects provide electronic food benefits over summer months to households with children in order to make up for school meals that children miss when school is out of session and as an alternative to Summer Food Service Program meals. The projects were originally authorized and funded in the FY2010 appropriations law ( P.L. 111-80 ). The enacted appropriation provides $28 million, a $5 million increase from FY2017. 
+ The child nutrition programs and WIC were up for reauthorization in 2016, but it was not completed. 18 Many provisions of the operating law nominally expired at the end of FY2015, but nearly all operations continued via funding provided in appropriations laws since that time, including the enacted FY2018 appropriation. The enacted appropriation also continued to extend, through September 30, 2018, two expiring provisions: mandatory funding for an Information Clearinghouse and USDA's food safety audits. 
+
+ Child Nutrition Programs: General Provisions 
+
+ General provisions in the enacted FY2018 appropriation included additional funding for child nutrition programs: 
+ Farm to School Grants. Section 763 of the enacted appropriation provides $5 million for competitive grants to assist schools and nonprofit entities in establishing farm-to-school programs. The same amount was provided in FY2017. This is in addition to $5 million in permanent mandatory funding (provided annually by Section 18 of the Richard B. Russell National School Lunch Act), for a total of $10 million available in FY2018.
+
+ School Personnel Training . Section 755 of the enacted appropriation provides $2 million for "allied professional associations to develop a training program for school nutrition personnel that focuses on school food service meal preparation and workforce development." This was not included in FY2017 appropriations.
+ FY2018 general provisions also included policy provisions : 
+ Processed Poultry from China. The enacted appropriation includes a policy provision (§728) to prevent any processed poultry imported from China from being included in the National School Lunch Program, School Breakfast Program, Child and Adult Care Food Program, and Summer Food Service Program. This policy has been included in enacted appropriations laws since FY2015. 19 
+
+ Certain Types of Discrimination in the School Meals Programs. 20 The enacted appropriation includes a provision (§768) that prohibits USDA from using the appropriated funds in a way that violates specific federal statute and regulations that bar discrimination against children eligible for free or reduced-price (F/RP) meals and prohibit certain stigmatizing practices. 21 Specifically, the referenced statute and regulations prohibit schools from physically segregating F/RP-eligible children (e.g., through separate lunch lines) and overtly identifying children using special tokens, tickets, lists of names, or other means. The regulations also prohibit schools from making F/RP-eligible children work in exchange for food or providing different types of food to these children.
+
+ Paid Lunch Equity. For school year 2018-2019, Section 775 of the enacted appropriation changes federal policy on the pricing of paid (full-price) meals. Included in the 2010 child nutrition reauthorization, and first implemented in the 2011-2012 school year, this policy required schools annually to review their revenue from paid lunches and to determine, using a calculation specified in law and regulation, whether paid prices had to be increased. 22 The purpose of the calculation was to ensure that federal funding intended for F/RP meals was not instead subsidizing full-price meals. For school year 2018-2019, the enacted appropriation requires a smaller subset of schools—only those with a negative balance in their nonprofit school food service account as of January 31, 2018—to be subject to this calculation and potentially to be required to raise prices.
+ 
+ 
+ 
+ 
+ A Note on School Meals Nutrition Standards 23 
+
+ Unlike recent appropriations laws, the enacted FY2018 appropriation does not include provisions specific to the updated nutrition standards for school meals. 24 For school year 2018-2019, the school meals programs (the National School Lunch Program and School Breakfast Program) are operating under an interim final rule that was published by FNS in November 2017. 25 The interim final rule: (1) allows states to exempt some school food authorities from the requirement that 100% of grain products must be whole grain-rich, 26 (2) prevents a further required reduction in sodium, 27 and (3) allows schools to offer flavored, low-fat milk. Recently, USDA published a final rule that applies to school year 2019-2020 and onwards. 28 The final rule (1) changes the whole grain requirement, requiring at least 50% of whole grains offered weekly in school meals to be whole grain-rich; (2) postpones the next sodium target and eliminates the final target; 29 and (3) allows schools to offer flavored, low-fat milk.
+
+ 
+ 
+ 
+ 
+
+ WIC Program 30 
+
+ Although WIC is a discretionary funded program, since the late 1990s the practice of the appropriations committees has been to provide enough funds for WIC to serve all projected participants. 31 
+
+ The enacted FY2018 appropriation provides $6.175 billion for WIC; however, the law also rescinds available carryover funds from past years. This funding level is $175 million less than the FY2017 appropriation. The enacted appropriation also includes set-asides for WIC breastfeeding peer counselors and related activities ("not less than $60 million") and infrastructure ($14.0 million). These set-asides are approximately equal to FY2017 levels. In addition, the appropriation sets aside $25 million for WIC's contingency fund; these reserve funds are to remain available until expended.
+
+ The enacted appropriation (§724) rescinds $800 million in prior-year (or carryover) WIC funds (reflected in Table 1 ). Both reported bills would also have rescinded carryover funds: H.R. 3268 (§741) would have rescinded $600 million; S. 1603 (§741) would have rescinded $800 million. The enacted appropriation's explanatory statement indicates that "the agreement fully funds estimated WIC participation in fiscal year 2018." 
+
+ Commodity Assistance Program
+
+ The Commodity Assistance Program budget account supports several discretionary programs and activities: (1) Commodity Supplemental Food Program (CSFP), (2) funding for TEFAP administrative and distribution costs, (3) the WIC Farmers' Market Nutrition Program (FMNP), and (4) special Pacific Island assistance for nuclear-test-affected zones in the Pacific (the Marshall Islands) and areas affected by natural disasters.
+
+ The enacted appropriation provides over $322 million for this account, an increase of $7 million compared to FY2017. The increase is for CSFP (+$14 million) and TEFAP administrative costs (+$5 million). In addition to this discretionary TEFAP funding, the law allows the conversion of up to 15% of TEFAP mandatory commodity funding (included in the SNAP account discussed above) to administrative and distribution costs. 
+
+ The law keeps WIC FMNP at the FY2017 level, though the President's budget requested no funding for this program.
+
+ Nutrition Programs Administration
+
+ This budget account funds federal administration of all the USDA domestic food assistance program areas noted previously; special projects for improving the integrity and quality of these programs; and the Center for Nutrition Policy and Promotion, which provides nutrition education and information to consumers (including various dietary guides). 
+
+ The enacted appropriation provides nearly $154 million for this account, a decrease of approximately $17 million from FY2017. 32 As in FY2017 and prior years, the law sets aside $2 million for the fellowship programs administered by the Congressional Hunger Center. 
+
+ Other Nutrition Funding Support
+
+ Domestic food assistance programs also receive funds from sources other than appropriations:
+ USDA provides commodity foods to the child nutrition programs using funds other than those in the child nutrition account. These purchases are financed through post-transfer "Section 32" funds. 33 For example, about $465 million out of a total of $1.9 billion in entitlement commodity support for the National School Lunch Program in FY2017 came from outside the child nutrition account. 34 
+
+ The Fresh Fruit and Vegetable Program (FFVP) for selected elementary schools nationwide is financed with permanent, mandatory funding. The underlying law (Section 19 of the Richard B. Russell National School Lunch Act) provides funds at the beginning of every school year (July). In FY2017 and prior years, appropriations laws have delayed a portion of the funds (generally $125 million) to the start of the next fiscal year (October 1). In the FY2018 appropriations law, this delay was not included, so for FY2018 USDA received both the full amount for the fiscal year ($172 million) on July 1, 2018, and $125 million that FY2017 appropriations had delayed until October 1, 2017. Therefore, funding for FFVP in FY2018 is higher than in previous fiscal years.
+
+ The Food Service Management Institute (technical assistance to child nutrition providers, also known as the Institute of Child Nutrition) is funded through a permanent annual appropriation of $5 million.
+
+ The Senior Farmers' Market Nutrition program receives nearly $21 million of mandatory funding per year (FY2002-FY2018) outside of the regular appropriations process. 35 
+ 
+
+ 
+
+ 
+ Author Contact Information
+ 
+ Randy Alison Aussenberg, Specialist in Nutrition Assistance Policy
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ Kara Clifford Billings, Analyst in Social Policy
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ Nutrition Programs Administration funding funds USDA's Center for Nutrition Policy and Promotion (CNPP), and the bill also provides some funding initially to FNS that is routinely transferred to other federal agencies.
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ See CRS Report R45084, 2017 Disaster Supplemental Appropriations: Overview ; and CRS In Focus IF10829, Agriculture Funding in the Bipartisan Budget Act of 2018 .
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ See CRS Report R44582, Overview of Funding Mechanisms in the Federal Budget Process, and Selected Examples .
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ See CRS Report R42388, The Congressional Appropriations Process: An Introduction .
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ See CRS Report 98-560, Baselines and Scorekeeping in the Federal Budget Process .
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ P.L. 113-79 . See CRS In Focus IF10783, Farm Bill Primer: Budget Issues .
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ P.L. 111-296 . See CRS Report R44373, Tracking the Next Child Nutrition Reauthorization: An Overview .
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ USDA-FNS FY2018 Congressional Budget Justification, pp. 32-91 through 32-94, http://www.obpa.usda.gov/32fnsexnotes2018.pdf .
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ Congressional Budget Office (CBO), Proposals for the Supplemental Nutrition Assistance Program—CBO's Estimate of the President's Fiscal Year 2018 Budget , July 13, 2017, https://www.cbo.gov/publication/52903 .
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ See CRS Report R45275, The House and Senate 2018 Farm Bills (H.R. 2): A Side-by-Side Comparison with Current Law . 
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ See also USDA-FNS Congressional Budget Justification, p. 32-86, http://www.obpa.usda.gov/32fnsexnotes2018.pdf . As an appropriated, open-ended mandatory program, SNAP funding is not the same as SNAP spending. SNAP regularly receives annual appropriations that are greater than the amount the program spends. Better measures for SNAP program spending can be found in USDA-FNS's costs data, available at http://www.fns.usda.gov/pd/SNAPmain.htm . 
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ These funds, held in reserve, are available for a two year period, whereas the majority of SNAP funds are available for one-year. These reserve funds are available for spending if the other SNAP appropriations are exhausted. 
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ USDA-FNS, "Enhancing Retailer Standards in the Supplemental Nutrition Assistance Program (SNAP)," 81 Federal Register 90675-90699, December 15, 2016. For further information on this rulemaking and implementation following the FY2017 appropriations law, see CRS Report R44650, Updated Standards for SNAP-Authorized Retailers . 
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ The proposed rule's preamble states that, aside from the farm bill change, FNS is "using existing authority in [SNAP's authorizing statute] and feedback from a Request for Information that included five listening sessions in urban and rural locations across the nation and generated 233 public comments."
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ See USDA-FNS website, "Is My Store Eligible?" https://www.fns.usda.gov/snap/my-store-eligible . 
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ Further background on these programs and related funding is provided in CRS Report R43783, School Meals Programs and Other USDA Child Nutrition Programs: A Primer .
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ For more information about these grants, see USDA-FNS's resources for the FY2017 grants, https://www.fns.usda.gov/fy-2017-nslp-equipment-assistance-grants-school-food-authorities .
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ Committees of jurisdiction marked up bills in the 114 th Congress, but Congress did not complete reauthorization. As of the date of this report, the 115 th Congress has not resumed reauthorization activity. Current operations and legislative activity are discussed in CRS Report R44373, Tracking the Next Child Nutrition Reauthorization: An Overview .)
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ In 2017, China exported nearly 500 pounds of processed chicken that was sourced from other countries. China has not exported any poultry to the United States in 2018. USDA's Food Safety and Inspection Service issued a proposed rule in June 2017 that recognizes the equivalency of China's poultry slaughter system. Once finalized, China would be able to export processed poultry that is domestically raised. For more information, see CRS In Focus IF10148, Chicken Imports from China .
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ For further background on treatment of unpaid meal debts and "lunch shaming" in the school meals programs, see "Selected Current Issues in the USDA Child Nutrition Programs" in CRS Report R43783, School Meals Programs and Other USDA Child Nutrition Programs: A Primer .
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ The provision states that "None of the funds made available by this Act may be used in contravention of" Section 9(b)(10) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)(10)) and 7 C.F.R. §245.8.
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ Section 205 of the Healthy, Hunger-free Kids Act of 2010 ( P.L. 111-296 ) (an amendment to the Richard B. Russell National School Lunch Act codified at 42 U.S.C. 1760(p)). See, for example, USDA-FNS "Child Nutrition Reauthorization 2010: Guidance on Paid Lunch Equity and Revenue from Nonprogram Foods," October 24, 2011, https://www.fns.usda.gov/guidance-paid-lunch-equity-and-revenue-nonprogram-foods . 
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ The Healthy, Hunger-free Kids Act of 2010 ( P.L. 111-296 ) established a timeline for USDA to update nutrition standards for school meal programs. The final rule was published in January 2012, and the updated nutrition standards phased in beginning in school year 2013-2014. For further background, see "Selected Current Issues in the USDA Child Nutrition Programs" in CRS Report R43783, School Meals Programs and Other USDA Child Nutrition Programs: A Primer .
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ Previously, the FY2015 ( P.L. 113-235 ), FY2016 ( P.L. 114-113 ), and FY2017 ( P.L. 115-31 ) appropriations laws made similar adjustments (using slightly different language) to whole grain and sodium requirements for school years 2015-2016, 2016-2017, and 2017-2018, respectively. The FY2017 law also included a provision that required USDA to permit states to grant special exemptions to serve flavored, low-fat milk.
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ USDA-FNS, "Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements; Interim Final Rule," 82 Federal Register 56703, November 30, 2017, https://www.federalregister.gov/documents/2017/11/30/2017-25799/child-nutrition-programs-flexibilities-for-milk-whole-grains-and-sodium-requirements . 
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ Schools can apply for exemptions for one or more products if they can demonstrate hardship in meeting the whole grain-rich requirement. Schools with exemptions must maintain a 50% whole grain minimum, the requirement before school year 2014-2015.
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ Specifically, the interim final rule continues Target 1 sodium limits in place of the scheduled Target 2 limits. 
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ USDA-FNS, "Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements," 83 Federal Register 63775, December 12, 2018, https://www.federalregister.gov/documents/2018/12/12/2018-26762/child-nutrition-programs-flexibilities-for-milk-whole-grains-and-sodium-requirements .
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ Specifically, the final rule postpones Target 2 and eliminates Target 3 sodium limits.
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ Further background on this program and related funding is provided in CRS Report R44115, A Primer on WIC: The Special Supplemental Nutrition Program for Women, Infants, and Children . 
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ ERS, "Anecdotal Evidence Suggest That WIC Became Fully Funded Sometime in the Late 1990s," in The WIC Program: Background, Trends, and Economic Issues, 2015 Edition , EIB-134, January 2015, p. 19. 
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ In FY2017, the appropriations law provided a $17.7 million set-aside for FNS's relocation and related expenses. These funds are available until expended.
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ For further background, see CRS Report RL34081, Farm and Food Support Under USDA's Section 32 Program .
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ See USDA-FNS 2019 Congressional Budget Justification, p. 32-20, https://www.obpa.usda.gov/32fns2019notes.pdf and USDA-AMS 2019 Congressional Budget Justification, p. 21-91, https://www.obpa.usda.gov/21ams2019notes.pdf .
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ Authorizing language at Section 4402 of the 2002 farm bill ( P.L. 107-171 ), most recently amended by Section 4203 of the 2014 farm bill ( P.L. 113-79 ), codified at 7 U.S.C. §3007.
\ No newline at end of file
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@@ -0,0 +1,774 @@
+Washington Metropolitan Area Transit 
+Authority (WMATA): Issues and Options 
+for Congress 
+
+ John W. Fischer 
+ Specialist in Transportation Policy 
+
+ William J. Mallett 
+ Specialist in Transportation Policy 
+
+April 14, 2010 
+
+ Congressional Research Service 
+
+7-5700 
+
+www.crs.gov 
+
+R41191 
+
+ CRS Report for Congress
+ P 
+
+ repared for Members and Committees of Congress 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+ Summary 
+
+A decade ago the Washington Metropolitan Area Transit Authority (WMATA, frequently referred 
+to as Metro), especially its Metrorail system, was viewed by many as the model U.S. metropolitan 
+transit operation. In 2010, the view is changed. The fatal accidents of 2009, other safety 
+problems, ongoing service interruptions, funding problems, and a perceived lack of management 
+direction have caused many in the region and in Congress to believe that substantive changes are 
+needed in its funding, structure, and operations. Although WMATA is a regional body, Congress 
+played an instrumental role in its creation, and continues to play an ongoing role in the financing 
+of the system. This report provides background information about the system, describes the major 
+issues WMATA currently faces, and discusses possible approaches for addressing these issues. 
+
+WMATA’s funding, management, and safety are the three main issues that are likely to be of most 
+interest to Congress. Funding is a perennial problem for WMATA, as it is for most public transit 
+agencies, because it is heavily reliant on government support to cover both capital and operating 
+costs. Transit advocates argue that the federal government ought to substantially increase the 
+resources it devotes to supporting buses and trains. But a general increase in federal transit 
+funding is unlikely to make a great difference to WMATA, so many argue for special federal 
+funding. Congress has already authorized $150 million per year over a 10-year period for 
+WMATA, but Congress might decide to revisit this decision in light of its current problems. Other 
+approaches might be to pursue ways to encourage WMATA to boost revenues from fares and 
+other revenues, to encourage the jurisdictions to fund the expenses of paratransit from sources 
+other than transportation system revenues, or to encourage states and localities to inject more 
+competition into the provision of transit service. 
+
+WMATA’s management structure, in particular its Board, is not based on a private sector 
+corporation model, but is probably best viewed as following a public utility model. In this public 
+utility framework, the general manager is heavily constrained by the Board in his/her ability to 
+make crucial decisions on what would otherwise be viewed as normal business activities in a 
+private sector transportation firm—for example, fare setting, route selection, and frequency of 
+service determinations. Some are concerned that WMATA’s Board lacks the subject expertise and 
+political independence necessary to evaluate operational decisions in the context of what is the 
+best decision from a transit operating perspective (e.g., maximizing productivity) as opposed to 
+the political perspective (e.g., the popularity of a fare increase). Congress, therefore, might 
+choose to take a serious look at WMATA’s governance structure. 
+
+A number of recent incidents resulting in deaths, injuries, and property damage have raised public 
+concern about the safety of WMATA’s operations. Ultimately, safety is the responsibility of 
+WMATA, and federal regulation of transit safety is largely prohibited by law. However, federal 
+law requires states with rail systems, other than commuter rail systems already regulated by the 
+Federal Railroad Administration (FRA), to establish a safety oversight program, and establish an 
+organization to oversee safety of rail transit systems. Metrorail is overseen by the Tri-State 
+Oversight Committee (TOC). A federal review of WMATA and its oversight reported severe 
+problems with the TOC, including a lack of resources, and that WMATA’s Safety Department is 
+in disarray. Other reports have come to similar conclusions. One option for Congress to improve 
+public transit safety might be to provide funding for State Safety Oversight (SSO) organizations, 
+including funds for training. Another option might be to provide the Federal Transit 
+Administration (FTA) with much stronger regulatory authority, as the Department of 
+Transportation (DOT) has proposed in draft legislation.
+
+ Congressional Research Service 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+ Contents 
+
+Introduction ................................................................................................................................ 1 
+
+Background ................................................................................................................................ 1 
+
+Issues.......................................................................................................................................... 3 
+
+Funding ................................................................................................................................ 3 
+Management ......................................................................................................................... 5 
+Safety ................................................................................................................................... 6 
+
+Tri-State Oversight Committee........................................................................................ 7 
+WMATA’s Safety Department ......................................................................................... 7 
+
+Options for Congress .................................................................................................................. 8 
+
+Funding ................................................................................................................................ 8 
+Management ......................................................................................................................... 9 
+Safety ................................................................................................................................. 10 
+
+Final Observation...................................................................................................................... 11 
+
+ 
+
+ Contacts 
+
+Author Contact Information ...................................................................................................... 11 
+
+ 
+
+ Congressional Research Service 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+ Introduction 
+
+Slightly less than a decade ago the Washington Metro system was viewed by many as 
+“magnificent” and successful.1 For some observers of the time, the Washington Metropolitan Area 
+Transit Authority (WMATA, frequently referred to as Metro), especially its Metrorail system, was 
+the model U.S. metropolitan transit operation. In 2010, the view is changed. The fatal accidents of 
+2009, the discovery of additional safety problems (both actual failures and systematic cultural 
+issues), ongoing service interruptions, system-wide funding problems, and a perceived lack of 
+management direction have caused many in the region and in Congress to believe that substantive 
+changes are needed in the funding, structure, and operations of WMATA. 
+
+Although WMATA is a regional body, Congress played an instrumental role in its creation, and 
+continues to play an ongoing role in the financing of the system. It is not a stretch to say that 
+Metro, especially Metrorail, would not exist but for the extensive funding and support that 
+Congress has provided to the system over the last 40-some years and continues to provide. This 
+report provides background information about the system, describes the major issues WMATA 
+currently faces, and discusses possible approaches for addressing these issues. 
+
+ Background 
+
+WMATA was created in 1967 by interstate compact involving Maryland, Virginia, and the 
+District of Columbia, together with the consent of Congress provided in the Washington 
+Metropolitan Area Transit Authority Compact (P.L. 89-774). The compact, originally created for 
+the planning, financing, building, and operation of a transit rail system in the Washington area, 
+has been amended several times through the years for a number of reasons. Most recently, it was 
+amended so that WMATA could become eligible to receive federal grants authorized by the 
+Passenger Rail Investment and Improvement Act of 2008 (P.L. 110-432). The main changes to the 
+compact were the addition of two federal representatives to the Board of Directors and the 
+creation of an Office of the Inspector General (P.L. 111-62). Among its many elements, the 
+compact prescribes the operational area for WMATA to include the District of Columbia, the 
+Maryland counties of Montgomery and Prince George’s, the Virginia counties of Arlington, 
+Fairfax, and Loudoun, and the Virginia cities of Alexandria, Falls Church, and Fairfax. WMATA 
+currently provides transit service in all of these jurisdictions except Loudoun County. 
+
+WMATA provides three types of transit service: heavy rail/subway (known as Metrorail), bus 
+(known as Metrobus), and paratransit (known as MetroAccess). Metrorail is the largest element 
+of the WMATA system, accounting for about two-thirds of its passenger trips. Average weekday 
+unlinked passenger trips number about 935,000.2 Between 1999 and 2008, ridership increased by 
+35%.3 WMATA began building the Metrorail system in 1969, and opened its first stations to 
+
+ 
+1 See, for example, William L. Middleton, “Washington's Magnificent Metro,” Railway Age , September 2001, p. 67. 
+2 American Public Transportation Association (APTA), “Public Transportation Ridership Report, Fourth Quarter 
+2009,” March 2, 2010, http://www.apta.com/resources/statistics/Documents/Ridership/2009_q4_ridership_APTA.pdf. 
+According to APTA an unlinked trip is defined as “a trip on one transit vehicle regardless of the type of fare paid or 
+transfer presented. A person riding only one vehicle from origin to destination takes ONE unlinked passenger trip; a 
+person who transfers to a second vehicle takes TWO unlinked passenger trips.” 
+3 U.S. Department of Transportation, Federal Transit Administration (FTA), National Transit Database. 
+
+ Congressional Research Service 
+
+ 1 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+passenger service in 1976. The originally planned 103-mile, 83-station system was completed in 
+2001. A 3-mile extension to Largo Town Center (Maryland) on the Blue Line with two new 
+stations and a new station on the Red Line were completed in 2004, so that the system currently 
+extends 106 miles with 86 stations. Work has begun on the first phase of a two-phase, 23-mile 
+extension of the system to Dulles International Airport and a terminal station in Loudoun County, 
+Virginia. When completed, the two-phase extension will include 11 new stations. Whereas all of 
+the 106-mile system was constructed by WMATA, the new Silver Line is being constructed by 
+the Washington Metropolitan Airports Authority (WMAA, the operator of Reagan National and 
+Dulles International airports). When operating segments are completed they, along with the 
+existing system, will be operated and maintained by WMATA. The first phase, to Reston, VA, is 
+scheduled to open in 2013. 
+
+Metrobus provides most of the rest of WMATA’s passenger trips, accounting for about one-third 
+of overall trips. Average weekday unlinked trips number about 408,000.4 Between 1999 and 2008, 
+ridership declined by about 5%.5 WMATA created the Metrobus system in 1973, when it was 
+forced to take over four failing privately owned bus companies then providing most of the transit 
+service in the metropolitan region. Today, WMATA operates regional bus services with costs 
+allocated among the jurisdictions and locally sponsored bus operations with costs charged directly 
+to the relevant jurisdiction. In some cases, local jurisdictions have decided to set up their own 
+local bus service.6 For example, Arlington County provides bus service and paratransit under the 
+name Arlington Transit (ART). WMATA owns and operates about 1,500 buses on approximately 
+350 routes.7 
+
+Paratransit service provided by Metro, known as MetroAccess, began in 1994. Door-to-door 
+service is provided for people who cannot use regular transit service, as required by the 
+Americans with Disabilities Act of 1990 (P.L. 101-336). Less than 1% of all WMATA passenger 
+trips are provided by MetroAccess. WMATA owns about 450 vehicles to provide service, but 
+contracts with a private company to operate the service. The private operator has another roughly 
+40 vehicles, and also contracts with taxi companies to provide rides.8 Between 1999 and 2008, 
+MetroAccess ridership increased eight-fold from 210,000 trips to 1.7 million annually.9 The 
+growth in ridership has become an important issue because MetroAccess trips are expensive to 
+provide and generate little in passenger revenue. In its proposed FY2011 budget, WMATA 
+estimates operating costs of about $38 per MetroAccess trip, of which fares cover only 5% of 
+those costs.10 
+
+WMATA is the largest but not the sole provider of public transit service in the Washington, DC, 
+metropolitan area. Two other agencies, the Maryland Transit Administration (MTA) and Virginia 
+ 
+4 APTA, Ridership Report. 
+5 FTA, National Transit Database. 
+6 Panel on the Analysis of and Potential for Alternate Dedicated Revenue Sources for WMATA, Report of the Metro 
+Funding Panel, Washington, DC, January 6, 2005, p. 17, http://www.mwcog.org/uploads/committee-documents/
+pVxfXFs20050106084602.pdf. 
+7 Washington Area Metropolitan Transit Authority, Proposed Fiscal 2011 Annual Budget , February 2, 2010, pp. 18-19, 
+http://www.wmata.com/about_metro/docs/FY2011_Proposed_Budget.pdf. 
+8 National Capital Region Transportation Planning Board, Metropolitan Washington Council of Governments, 
+ Independent Review of the Washington Metropolitan Area Transit Authority’s (WMATA) MetroAccess Service: Final 
+Report , November 25, 2008, http://www.mwcog.org/uploads/committee-documents/bl5dWV5Z20081201124410.pdf. 
+9 FTA, National Transit Database. 
+10 Washington Area Metropolitan Transit Authority, Proposed Fiscal 2011 Annual Budget , pp . 33, 40. 
+
+ Congressional Research Service 
+
+ 2 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+Railway Express (VRE), provide commuter rail, a type of transit not provided by WMATA. 
+Moreover, as noted above, many jurisdictions have established their own local bus services to 
+supplement WMATA’s bus and rail service. According to data published by the American Public 
+Transportation Association (APTA), WMATA accounted for about 88% of public transit trips in 
+the Washington region in 2007.11 
+
+In terms of ridership, WMATA is the fourth-largest transit agency in the nation. Its rail system 
+ranks second behind only New York, and its bus system is sixth-largest. Although WMATA has 
+many unique problems operating in a multistate and multijurisdictional setting that includes the 
+nation’s capital, many of the same issues being faced by WMATA can be identified at transit 
+operations throughout the United States. 
+
+ Issues 
+
+ Funding 
+
+WMATA has faced budgetary challenges through its history, in part because of its reliance on 
+government support for a large share of its funding. WMATA, like all public transit agencies, is 
+funded by a combination of farebox revenues and other revenues, such as parking fees, and 
+government support from federal, state, and local sources.12 Of all funds expended by WMATA in 
+FY2008, about 40% were from fares and other revenues; 33% were from local government; 15% 
+were from state government; and 12% were from the federal government.13 In FY2008, operating 
+and capital expenditures were 73% and 27% of the total, respectively. Most federal funds go 
+toward capital expenses. In WMATA’s case, federal funds applied to capital expenditures were 
+$225 million in FY2008, accounting for about 42% of all capital expenditures. With another 
+$18 million of federal funds going to operating expenditures, federal assistance in FY2008 
+totaled about $243 million. 
+
+Budget challenges have been heightened recently by the economic downturn that has reduced 
+ridership, and thus farebox revenue, and other revenue such as advertising. WMATA’s financial 
+position has also been damaged by, among other things, the June 2009 crash on the Red Line that 
+will likely increase its liability insurance costs, and increasing health care insurance premiums for 
+its employees. In these circumstances, WMATA believes that without a change in fares or 
+government support it faces a $189.2 million gap in its operating budget for FY2011 of $1,489 
+million.14 WMATA has proposed several options for dealing with this budget gap that combine 
+various mixes of fare increases, service cuts, and increased government support. On the capital 
+side, WMATA believes it has about $11 billion worth of capital needs over the next 10 years, or 
+$1.1 billion per year, whereas its capital budget for FY2011 is $721.3 million.15 
+
+ 
+11 American Public Transportation Association (APTA), Public Transportation Fact Book, 2009 (Washington, DC, 
+April 2009, tables 3 and 4, http://www.apta.com/gap/policyresearch/Documents/APTA_2009_Fact_Book.pdf. 
+12 For more information, see CRS Report RL34183, Public Transit Program Funding Issues in Surface Transportation 
+Reauthorization , by William J. Mallett. 
+13 FTA, National Transit Database. 
+14 WMATA, Proposed Fiscal 2011 Annual Budget 
+15 Ibid. 
+
+ Congressional Research Service 
+
+ 3 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+Many attribute WMATA’s troubles to the fact that unlike most other major transit agencies it has 
+not, for most of its history, received much state and local government funding from dedicated 
+sources.16 A dedicated revenue source, according to the Federal Transit Administration (FTA), is 
+“any funds raised specifically for transit purposes and which are dedicated at their source, rather 
+than through an appropriation of general funds.”17 Thus, WMATA has been largely reliant on state 
+and local government annual appropriations. Many contend that this has constrained funding, 
+made it more uncertain, and, therefore, made it difficult to do long-term planning.18 A lack of 
+dedicated funding may also damage a transit agency’s credit rating and thus increase the cost of 
+borrowing. To encourage Maryland, Virginia, and the District of Columbia to provide WMATA 
+with dedicated funding, Congress enacted Title VI of the Passenger Rail Investment and 
+Improvement Act of 2008 (P.L. 110-432), which authorizes $1.5 billion of federal funds over 10 
+years if the states and the District match this money with dedicated funding. To take advantage of 
+this opportunity, the jurisdictions amended the compact and Congress granted its consent (P.L. 
+111-62). The first $150 million of federal money was appropriated in the Consolidated 
+Appropriations Act, 2010 (P.L. 111-117). In unrelated legislation, WMATA also received 
+$201.8 million from the American Recovery and Reinvestment Act of 2009 (ARRA; P.L. 111-5). 
+
+The most direct source of “dedicated” funding is, of course, the money that transit agencies 
+generate from fares and other operating (e.g., parking) and non-operating sources (e.g., real estate 
+agreements). WMATA does comparatively well in recovering a portion of its operating costs. In 
+FY2009, cost recovery was 56% overall, with rail service recovering 79%, bus service 31%, and 
+paratransit just 5%.19 Moreover, since 1990, operating cost recovery for rail and bus service has 
+been relatively stable, between 70% and 80% for the former, and between 30% and 40% for the 
+latter.20 However, government subsidies have grown substantially, according to the summary of a 
+non-public report commissioned by WMATA’s governing Board.21 According to the summary, 
+between FY2000 and FY2009, the amount of subsidy for MetroAccess has increased 321%, 
+while the subsidies for bus and rail service have increased 89% and 12%, respectively. 
+Consequently, it appears that the report recommends the agency pay close attention to cost 
+recovery, targeting 80% in its rail system and 35% in its bus system. Not surprisingly, the report 
+also recommends that WMATA needs to control the growth in expenditures for paratransit 
+service. 
+
+ 
+16 See, for example, Robert Puentes, Washington’s Metro: Deficits by Design , Brookings Institution, Brookings 
+Institution Series on Transportation Reform, Washington, DC, June 2004, http://www.brookings.edu/~/media/Files/rc/
+reports/2004/06metropolitanpolicy_puentes/20040603_puentes.pdf. 
+17 FTA, National Transit Database, “NTD Glossary,” http://www.ntdprogram.gov/ntdprogram/Glossary.htm#D. 
+18 See, for example, U.S. Government Accountability Office, Issues Related to Providing Dedicated Funding for the 
+Washington Metropolitan Area Transit Authority , GAO-06-516, May 2006, http://www.gao.gov/new.items/
+d06516.pdf. 
+19 WMATA, Proposed Fiscal 2011 Annual Budget . The recovery of operating costs through farebox receipts and 
+business revenues tends to be higher in rail transit because rail riders are typically more willing to pay for what they 
+perceive to be a higher level of service. Moreover, rail transit tends to have higher capital costs relative to operating 
+costs compared with bus transit. 
+20 Panel on the Analysis of and Potential for Alternate Dedicated Revenue Sources for WMATA, Documents: Blue 
+Ribbon Questions, November 30, 2004, http://www.mwcog.org/committee/committee/documents.asp?
+COMMITTEE_ID=177. 
+21 Washington Area Metropolitan Transit Authority, Transit Expert Conducts Assessment of Metro , March 11, 2010, 
+http://www.wmata.com/about_metro/news/PressReleaseDetail.cfm?ReleaseID=4361. 
+
+ Congressional Research Service 
+
+ 4 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+ Management 
+
+The WMATA compact created a regional body charged almost exclusively with the goal of 
+building and operating the Metrorail system. It has no taxing powers, has limited regional 
+transportation planning powers, and at first it was not responsible for most of the transit services 
+being provided in the Washington metropolitan area. The compact was designed to create a Board 
+of Directors to oversee the Metrorail construction process and to create an operating agency for 
+the rail system. The Board largely reflected the political concessions needed to reach agreement 
+on moving Metrorail construction forward.22 Although the compact has been amended to 
+incorporate Metrobus and operating environment changes, the governance structure of the Board 
+was not changed. As constituted until 2009, the Board had six members: two appointed by the 
+District of Columbia’s City Council, two appointed by Maryland’s Washington Suburban Transit 
+Commission, and two by the Northern Virginia Transportation Commission. The Board selects its 
+own chairman and vice-chairman from among its membership and usually rotates these positions 
+annually. Board members are not paid, but are reimbursed for expenses. Members serve at the 
+pleasure of each appointing body and are not required to have any special expertise in transit 
+and/or transportation, or to have legal, financial, engineering, or business expertise. 
+
+In 2009, the WMATA compact was amended to comply with the provisions of the Passenger Rail 
+Investment and Improvement Act of 2008 (P.L. 111-62). This amendment required expansion of 
+the Board to eight members, two of whom now represent the federal interest in the system and are 
+appointed by the administrator of the General Services Administration. For the first time a Board 
+member is required to meet a specific requirement prior to appointment by the administrator, 
+namely that he/she is a regular user of either Metrorail or Metrobus (or both). 
+
+Perhaps the most important single duty of the Board is to appoint the system’s general manager 
+(GM). The Board also has the power to appoint several other officers, such as the treasurer and, 
+as a result of the 2009 compact amendments, an inspector general. The GM has broad 
+responsibilities for the organization and operation of WMATA, and oversees most of its day-to-
+day activities. Nonetheless, the Board retains final approval authority over most of the important 
+decisions put forward by management. Bus route changes, capital project spending (e.g., new bus 
+and railcar purchases), and—most importantly—fare increases must be approved by the Board. 
+And in many cases these proposed changes require extensive public hearings before the Board 
+will consider them. 
+
+WMATA’s structure, in particular its Board, is not based on a private sector corporation model. 
+Rather, it is probably best viewed as following a public utility model. This is not unique to 
+WMATA. Most U.S. transit properties operate on some sort of public utility model. The 
+differences, however, are that most other transit properties are not subject to the same level of 
+interstate and multijurisdictional oversight and, as was pointed out earlier, many other systems 
+have dedicated sources of funding besides fares and other business revenues. 
+
+In this public utility framework, the GM appears to have significant power in some areas, but 
+limited power in others. The GM can make a lot of day-to-day decisions, but his/her ability to 
+make crucial decisions on what would otherwise be viewed as normal business activities in a 
+
+ 
+22 Zachary M. Schrag, The Great Society Subway: A History of the Washington Metro (Baltimore: Johns Hopkins 
+University Press, 2006), pp. 101-103. 
+
+ Congressional Research Service 
+
+ 5 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+private sector transportation firm—for example, fare setting, route selection, and frequency of 
+service determinations—is instead subject to Board action. 
+
+Historically, the GM position has been a flashpoint for controversy. In the 43 years that the GM 
+position has existed there have been 13 GMs, five of whom served in either an acting or interim 
+capacity. The longest tenure of any GM was not quite nine and a half years (Richard White). One 
+other GM served nine years (Jackson Graham). A third GM served just over six and a half years. 
+None of the other 10 individuals holding the position lasted more than four years. The most 
+recent GM resigned in March 2010, at least in part as a result of the controversy surrounding the 
+safety problems experienced by the system over the last year. The GM position has not been 
+characterized by long-term stability, which could be construed by some as a potential 
+management issue. Similarly, the constant rotation of the Board chairmanship has been viewed as 
+a source of management instability. Most recently, former GM David Gunn, in his March 2010 
+review of WMATA’s current situation, called for the Board chairmanship to be a multi-year 
+position.23 
+
+During the past year’s safety investigation it has been routinely pointed out that WMATA’s 
+attention to safety has been diminished at least in part by management failures throughout the 
+organization. David Gunn’s recent review pointed to similar management problems in other parts 
+of WMATA’s operations. 
+
+ Safety 
+
+A number of recent incidents resulting in deaths, injuries, and significant property damage have 
+raised serious concerns about the safety of WMATA’s operations, particularly the safety of its rail 
+service. The most serious incident was a crash involving two Red Line trains on June 22, 2009, 
+killing nine and injuring 76. These incidents have also raised questions about the federal role in 
+transit safety.24 
+
+Ultimately, safety is the responsibility of the local transit authority, in this case WMATA. Federal 
+regulation of transit safety is largely prohibited by law. As stated in 49 USC §5334(b)(1), “except 
+for purposes of national defense or in the event of a national or regional emergency, the Secretary 
+may not regulate the operation, routes, or schedules of a public transportation system for which a 
+grant is made under this chapter.” However, federal law requires states with rail systems, other 
+than commuter rail systems already regulated by the Federal Railroad Administration (FRA), to 
+establish a safety oversight program (49 USC §5330). This safety oversight program is 
+administered by FTA, which has established the State Safety Oversight (SSO) rule (49 CFR Part 
+659). Under the safety oversight program, a state must establish an organization to oversee safety 
+of rail transit systems, and transit agencies are required to comply with the recommendations of 
+the oversight agency (49 USC §5330(c)(2)(C)). Metrorail is overseen by the Tri-State Oversight 
+Committee (TOC). 
+
+Despite this requirement, the enforcement of safety oversight by FTA and State Safety Oversight 
+organizations is considered by many to be very weak. The State Safety Oversight program law 
+and SSO rule provide no enforcement power to State Safety Oversight agencies and only allow 
+ 
+23 WMATA, http://www.wmata.com/about_metro/news/PressReleaseDetail.cfm?ReleaseID=4361. 
+24 See, for example, CRS Report R40688, The Federal Role in Rail Transit Safety , by David Randall Peterman and 
+William J. Mallett. 
+
+ Congressional Research Service 
+
+ 6 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+FTA the authority to withhold up to 5% of a transit agency’s urbanized area formula funds. The 
+FTA administrator, presumably referring to 49 USC §5334(b)(1), argued that 
+
+under current law, the FTA, like the TOC, has no legal authority to compel Washington 
+Metro to respond to any of our findings. As I have testified before, the FTA is actually 
+prohibited by law from issuing safety regulations of any kind. And the State Safety 
+Organizations like the TOC similarly have no legal authority to compel transit agencies like 
+Washington Metro to respond to their safety findings [emphasis in original]. They don’t 
+have to respond to them in a timely way. In fact, they don’t have to respond to them at all.25 
+
+Although they are not required to, some states do provide their safety agencies with enforcement 
+powers, such as ordering rail transit authorities to suspend service until a safety issue is resolved. 
+
+As part of the State Safety Oversight program, FTA conducts regularly scheduled audits of the 
+implementation of the SSO rule. After the Red Line crash of June 2009, a scheduled audit for 
+mid-2010 was brought forward to December 2009. A report from the audit was published March 
+4, 2010.26 The audit found severe problems with safety within WMATA and with the oversight 
+provided by the TOC. 
+
+ Tri-State Oversight Committee 
+
+Among the findings on the TOC, the audit found that resources from the member jurisdictions for 
+the operation of the TOC have been lacking, members of the TOC lack the direct authority for 
+decision making, and communication and coordination among TOC members and between TOC 
+and WMATA is often ineffective. For example, the audit report notes that the TOC has 
+communicated mainly with WMATA’s safety department, but not with its rail operations and 
+maintenance departments, nor, in serious situations, with WMATA’s executive staff or Board of 
+Directors. 
+
+On the issue of resources, the audit found that until early 2009 all six members of the TOC (two 
+each from DC, Maryland, and Virginia) were assigned to the committee as a part-time duty of 
+their regular job. Apparently, no background in rail transit safety was required, nor was any 
+training provided to serve on the TOC. The audit found that over its existence there has been a 
+good deal of turnover in the membership of the TOC. On a positive note, however, the audit 
+found that resources for contracted support for the TOC increased significantly in 2008 and 2009, 
+and that in early 2009 Virginia committed its first full-time member to the TOC. 
+
+ WMATA’s Safety Department 
+
+The audit report found that WMATA’s Safety Department is in disarray. The department has been 
+reorganized three times in the past four years and has lost much of its in-house safety expertise. 
+At the time of the audit, almost one-quarter (10 of 41) of the staff positions in the department, 
+
+ 
+25 Peter M. Rogoff, Administrator, Oral Statement on Federal Transit Administration’s Recent Audit of WMATA and 
+the Tri-State Oversight Committee , Federal Transit Administration, U.S. Department of Transportation, March 4, 2010, 
+http://www.fta.dot.gov/publications/publications_11325.html. 
+26 U.S. Department of Transportation, Federal Transit Administration, Audit of the Tri-State Oversight Committee and 
+the Washington Metropolitan Area Transit Authority , March 4, 2010, http://www.fta.dot.gov/documents/
+Final_SSO_Audit_Report_TOC_WMATA_03042010.pdf. 
+
+ Congressional Research Service 
+
+ 7 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+including all the positions dedicated to analyzing system-wide safety hazards, were vacant. The 
+audit noted “the Safety Department does not have the in-house capabilities to perform internal 
+safety audits and the Safety Department has insufficient resources to keep up with a growing 
+backlog of accident and incident investigations.”27 Moreover, the audit found that the Safety 
+Department is not an integral part of WMATA’s information gathering and decision making on 
+safety issues. Other reports have come to similar conclusions. For example, the report 
+commissioned by the WMATA Board, discussed above, suggests that WMATA’s work culture 
+does not encourage employees to report their safety concerns without fear of retribution.28 
+
+ Options for Congress 
+
+ Funding 
+
+Funding is a perennial problem for WMATA, as it is for most public transit agencies. Because of 
+this, transit advocates argue that the federal government ought to substantially increase the 
+resources it devotes to supporting buses and trains. As a recipient of regular federal public transit 
+program funds, both formula and discretionary, WMATA would benefit from such an increase. 
+Given the number of public transit agencies around the country that receive federal support, 
+however, a general increase in federal funding is unlikely to make a great difference to WMATA. 
+For this reason, and because of the federal government’s supposed special relationship with 
+WMATA, many argue for special federal funding. As noted earlier, Congress has already 
+authorized $1.5 billion over the next 10 years ($150 million a year) for WMATA as part of the 
+Passenger Rail Investment and Improvement Act of 2008. But Congress might decide to revisit 
+this question in light of the problems highlighted by the major Red Line crash last year. On the 
+other hand, transit agencies in other parts of the country might question this special treatment, 
+especially as the Metrorail system is also receiving $900 million in federal transit New Starts 
+program funding to build the first phase of an extension to Dulles International Airport. 
+
+Another option might be to pursue ways to encourage WMATA to boost revenues from fares and 
+other revenues. The greater the share coming from these sources, of course, the less pressure there 
+is on government sources. The share of funding that can be derived from non-governmental 
+sources is, in some measure, dependent on the extent to which the agency is run like a business as 
+opposed to public utility or social service agency. To run WMATA more like a business, Congress 
+might choose to encourage the affected state and local jurisdictions to give its management more 
+control over setting fares and routes. Using a more business-like model is probably most difficult 
+in the provision of paratransit service. In this case, Congress might encourage the jurisdictions to 
+fund the expenses of MetroAccess from a source other than transportation system revenues, as the 
+Metro Funding Panel suggested in its report,29 such as their social service budgets. 
+
+Congress might consider these options, and others like them, specifically in the case of WMATA 
+or more generally across the entire federal public transit program. In general, these options entail 
+encouraging states and localities to inject more competition into the provision of transit service or 
+to find other ways to reduce costs. This usually involves proposals to competitively bid transit 
+
+ 
+27 Ibid., p. 7. 
+28 WMATA, http://www.wmata.com/about_metro/news/PressReleaseDetail.cfm?ReleaseID=4361. 
+29 Panel on the Analysis of and Potential for Alternate Dedicated Revenue Sources for WMATA. 
+
+ Congressional Research Service 
+
+ 8 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+service provision and to allow private operators to provide new services to compete with public 
+transit agencies. This could be accomplished, according to some advocates, by making the 
+elimination of local barriers to privatization a condition of federal funding. In many places, these 
+local barriers take the form of state and local laws and regulations that give monopoly power to 
+regional transportation agencies. Some advocate loosening work rules in the transit industry in an 
+effort to boost productivity. This might, for example, include renegotiating contracts with transit 
+workers unions that often do not allow transit agencies to employ part-time workers or to require 
+split-shifts to cover the peaking of demand in the morning and evening. In addition, some argue 
+that federal labor protections in transit, commonly known as Section 13(c), should be abolished or 
+modified, a position opposed by unions representing transit workers. 
+
+ Management 
+
+It is widely perceived in the transportation community that WMATA “has always been a 
+politically weak institution with its functions restricted to transit. Although a board of local 
+officials governs it, WMATA only participates in, and does not direct, local or regional 
+transportation planning activities.”30 
+
+There is some evidence that WMATA has studied and/or changed its internal organizational and 
+management structure on numerous occasions over the last 40-some years. There is no evidence 
+that a similar study of the authority’s overall governance structure has taken place in that same 
+time period. This is not to say that there has been universal contentment with the WMATA 
+governance structure. The 2009 compact amendments, with their addition of two new Board 
+members and an inspector general, prove otherwise. But even in that instance there appears to 
+have been no serious call from the signatories to the compact to go back to square one and 
+examine whether WMATA can, or should, be strengthened as an organization or modernized 
+(perhaps corporatized) from a management perspective. 
+
+This situation, however, could be changing. In a recent editorial the Washington Post suggested 
+among other things that “[i]t’s time to rethink the compact and reengineer Metro’s Board of 
+Directors. The chairman should serve for multiple years, not just one. Elected officials should be 
+barred from moonlighting as board members.”31 
+
+The Post has not been alone in its views. The Greater Washington Board of Trade in a Letter to 
+the Editor echoed the Post ’s views and argued further that making positive changes in WMATA’s 
+governance structure needed to be a priority.32 
+
+There have been concerns expressed over time that WMATA’s Board lacks the subject expertise 
+and political freedom necessary to evaluate operational decisions in the context of what is the best 
+decision from a transit operating perspective (e.g., maximizing productivity) as opposed to the 
+political perspective (e.g., the popularity of a fare increase and/or its impact on specific electoral 
+and other groups). Hence, there is reluctance to raise fares and/or make service changes in a 
+
+ 
+30 Robert Puentes, Washington’s Metro: Deficits by Design, p. 16. 
+31 Editorial, “Getting Metro Right,” Washington Post , March 21, 2010, p. A-18. 
+32 James W. Dyke, Jr. and Jim Dinegar, “The Major Changes That Metro Needs,” Letter to the Editor on Behalf of the 
+Greater Washington Board of Trade, Washington Post , March 27, 2010, p. A-12. 
+
+ Congressional Research Service 
+
+ 9 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+timely fashion rather than always waiting until these decisions are necessitated by some operating 
+crisis such as the ongoing funding shortfall. 
+
+One of the options discussed in the funding section of this report is the concept of opening at least 
+some WMATA services to competition and/or privatization. Along these lines, representatives of 
+the Washington Airports Task Force, appearing before a Metro Funding Panel hearing in October 
+2004, suggested that WMATA’s performance could be improved if its structure was “allowed to 
+follow the best 21st century practice for ‘corporatized’ government transportation agencies.”33 The 
+testimony suggested, somewhat controversially, that WMATA did not need a dedicated source of 
+public funding because it already had one—the fare box—and offered the Washington 
+Metropolitan Airports Authority (WMAA) as a model for how a public agency could operate 
+without additional public subsidy by maximizing revenue collection from its assets (which 
+WMAA does through landing fees, concessions, etc.). In this context, it is important to note that it 
+is the WMAA that is managing the construction of the new Silver Line and has taken the 
+leadership in arranging for the line’s funding. 
+
+The WMAA model is one of many options that could be considered if regional governments 
+and/or Congress chose to take a serious look at WMATA’s governance structure. Interestingly, 
+when WMAA was created in the mid-1980s there were calls that the airports (Reagan National 
+and Dulles International) be placed under the WMATA umbrella, an idea ultimately rejected by 
+the Department of Transportation (DOT) and local governments. WMAA has a Board of 
+Directors, but the organization is set up much differently, with airport management having much 
+greater power over decision making on many issues. WMAA, it could be argued, has more 
+lucrative assets at its disposal, although some believe this is only true to the extent that WMATA 
+has been unable to take advantage of its property and other assets for ancillary revenue raising 
+purposes. 
+
+It could be argued that control of WMATA by local elected officials in a public utility-like 
+framework is appropriate, given that local government subsidies are a large part of WMATA’s 
+budget and the goals of transit are typically broader than transporting people at a price that covers 
+its costs. These goals are often said to include highway congestion mitigation; improving 
+environmental quality; mobility for the poor, elderly, and disabled; and economic development. 
+Improving WMATA in a public utility framework might not involve changing the structure of its 
+management, but rather getting Board members to provide greater attention to management 
+duties, insisting on a higher level of professional experience, and making changes that will lead to 
+management stability. For example, the Board chairmanship might be a four-year position instead 
+of the one-year position it is at the moment. 
+
+ Safety 
+
+Although rail and bus safety is the responsibility of WMATA and its supporting jurisdictions, 
+Congress might decide to strengthen the role of the federal government. Currently, as discussed 
+above, the federal government does not have the authority to regulate transit safety, nor does it 
+provide funding to states or transit agencies specifically for transit safety initiatives. FTA’s audit 
+of rail safety at WMATA found that its oversight organization has historically had a lack of 
+
+ 
+33 Panel on the Analysis of and Potential for Alternate Dedicated Revenue Sources for WMATA, “Comment by the 
+Washington Airports Task Force,” Public Hearing, October 19, 2004, http://www.mwcog.org/uploads/committee-
+documents/v11YX1g20041101143507.pdf. 
+
+ Congressional Research Service 
+
+ 10 
+
+ 
+ Washington Metropolitan Area Transit Authority (WMATA) 
+
+ 
+
+resources. One option for Congress to improve public transit safety, therefore, would be to 
+provide funding for State Safety Oversight organizations, including funds for training. 
+
+Another option would be to provide FTA with much stronger regulatory authority, as the 
+Department of Transportation (DOT) has proposed in draft legislation.34 This proposed legislation 
+would replace the State Safety Oversight provisions (49 USC §5330) by amending 49 USC §5329 
+to add a new public transportation safety program. This new program would require DOT to 
+establish a new rail safety program and would also provide DOT with the option of establishing a 
+bus safety program. DOT would be empowered to conduct inspections, investigations, and audits 
+of all aspects of public transit rail systems, except commuter rail systems that are already 
+regulated by FRA. Moreover, DOT would be permitted to delegate this responsibility to another 
+entity and provide grants, up to 100% of the costs, to carry out these activities. The proposed 
+legislation provides for the development of state safety programs, including safety programs 
+involving more than one state, with permission for DOT to provide grants. The legislation would 
+also provide much stronger enforcement mechanisms, including civil and criminal penalties, and 
+the ability to place emergency restrictions or prohibitions on a transit system. 
+
+As a part of the legislation proposed by DOT, the State Safety Oversight provisions would sunset 
+three years from the effective date of final regulations of the new safety program regulations. 
+Moreover, the legislation would amend 49 USC §5334(b)(1) to allow the federal government to 
+regulate transit agencies “for purposes of establishing and enforcing programs to improve the 
+safety of the nation’s public transportation systems, and reducing accidents on rail fixed guideway 
+and bus systems for public transportation.” 
+
+ Final Observation 
+
+WMATA remains at its core a regional/local body and responds primarily to the political and 
+social forces of that constituency. Major changes, if they were to occur, would likely arise from 
+regional/local concerns about WMATA. Congress in reviewing its role should be cognizant of the 
+compact and its provisions, but nonetheless aware that large sums of federal money are at play 
+and that it ultimately must define the federal interest in how these funds are used. 
+
+ 
+
+ Author Contact Information 
+
+ 
+John W. Fischer 
+
+ William J. Mallett 
+
+Specialist in Transportation Policy 
+
+Specialist in Transportation Policy 
+
+jfischer@crs.loc.gov, 7-7766 
+
+wmallett@crs.loc.gov, 7-2216 
+
+ 
+
+ 
+
+ 
+34 U.S. Department of Transportation, Federal Transit Administration, Letters to Congress and Proposed Bill to 
+Establish a Public Transportation Safety Program , December 9, 2009, http://fta.dot.gov/documents/
+PelosiTransit_12_07_09.pdf. 
+
+ Congressional Research Service 
+
+ 11
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+CRS.gov Sign In | Sign Up 
+
+Â 
+
+Search CRS.gov
+
+
+
+CRS REPORTS & ANALYSIS
+
+CRS Insights
+Obama Library Likely Headed to
+
+Chicago's South Side
+Daniel J. Richardson, Research Assistant (drichardson@crs.loc.gov , 7­2389)
+Wendy Ginsberg, Analyst in American National Government (wginsberg@crs.loc.gov,  7­3933)
+May 13, 2015 (IN10270)
+
+On May 12, 2015, the private foundation providing significant funding for the establishment
+of President Barack Obama's forthcoming presidential library announced  they intend to
+site the building in the South Side of Chicago. The bid to locate the library on Chicago's
+South Side was submitted by the University of Chicago, which was competing with
+proposals from the University of Illinois at Chicago, Columbia University in New York City,
+and the University of Hawaii in Honolulu.
+
+Presidential libraries are managed by the National Archives and Records Administration
+(NARA). This proposed presidential library would be the official depository for the
+presidential records from the Obama Administration. Although the library will likely be
+owned and administered by the federal government, the review of proposals for the
+library's location and design was facilitated by the  Barack Obama Foundation , a private,
+tax­exempt charity established in January 2014. This foundation is comparable to the
+private organizations involved with the design and construction of other presidential
+libraries. Like other presidential foundations, the Barack Obama Foundation is responsible
+for partnering with NARA and providing a substantial part of the funding for any future
+library structures. Unlike the other foundations, however, the Barack Obama Foundation
+will be the first to support a presidential library established since the enactment of the
+ Presidential Historical Records Preservation Act of 2008 , which requires higher levels of
+private financing.
+
+Congressional Review
+
+ 
+ Although the President has selected the site for his future library, his decision does not
+become final until the Archivist of the United States has approved the plan and Congress
+ has been provided an opportunity to express any disapproval. Under the Presidential
+Libraries Act (PLA, P.L. 84­373), passed in 1955 and subsequently amended in 1986, 2003,
+and 2008, Congress is provided 60 days of continuous session in which it can review and,
+if necessary, take action to stop the proposal.
+
+Construction and Financing for the Library
+
+The Presidential Libraries Act of 1986 (P.L. 99­323) amended the PLA to require significant
+private financing for future libraries and limit the size of library facilities. As part of these
+changes, private endowments were required to fund 20% of total construction, acquisition,
+and improvement costs for the site. Subsequent amendments in 2003 and 2008, however,
+increased this endowment requirement to 40% and then 60%, respectively. The Barack
+Obama Foundation will be the first private foundation required to meet the 60%
+endowment threshold. According to the Chicago Tribune , by the end of 2014 the foundation
+had raised between $2.9 million and $6.2 million of the projected $500 million that will be
+required.
+
+The 1986 amendments also established limits on public financing for library facilities that
+exceeded 70,000 square feet. Any construction beyond that square footage cap requires
+gradual increases in the endowment percentage. This square­footage restriction has
+applied to all presidents since George H. W. Bush.
+
+The Presidential Library System Nationwide
+
+The Barack Obama Presidential Library and Museum would become the 14t  
+
+h presidential
+
+library maintained by NARA, and the 5t  
+
+h associated with a university. As a consequence,
+
+the location of the library in Chicago would continue a recent trend in the establishment of
+presidential libraries. The first four presidential libraries—Roosevelt, Truman, Hoover, and
+Eisenhower—were located in the Presidents' hometowns or principle residences. Since that
+time, many Presidents have chosen to locate their libraries elsewhere, often with an
+affiliated university. Additional information on these trends is provided in CRS Report
+R41513,  The Presidential Libraries Act and the Establishment of Presidential Libraries , by
+Wendy Ginsberg, Erika K. Lunder, and Daniel J. Richardson. Table 1  lists the other 13
+presidential libraries currently under NARA's administration and indicates those with
+university affiliations. In recent years, these libraries have drawn close to 2 million
+combined annual visitors. In a study  commissioned by the University of Chicago to
+accompany its presidential library proposal, an economic research firm suggested that the
+proposed Obama Library could draw 800,000 annual visitors and provide an economic
+effect of $220 million per year. According to NARA, in FY2012, the most visited
+presidential library (the Ronald Reagan Presidential Library and Museum) experienced
+380,570 visitors. In 2011, the Archivist of the United States testified that local Chambers
+of Commerce and State Tourism Boards estimate that each visitor to a presidential library
+spends an additional $100­$200 at local restaurants and hotels.
+
+Additional information on the presidential library system and recent issues surrounding the
+ establishment of these libraries can be found in CRS Report R41513, The Presidential 
+
+ 
+ Libraries Act and the Establishment of Presidential Libraries , by Wendy Ginsberg, Erik a K.
+Lunder, and Daniel J. Richardson.
+
+Table 1. Presidential Library Facilities and Locations
+
+Facility Name
+
+Location
+
+Herbert Hoover Presidential Library and Museum West Branch, Iowa
+
+Franklin D. Roosevelt Presidential Library and
+
+Hyde Park, New York
+
+Museum
+
+Harry S. Truman Library and Museum
+
+Independence, Missouri
+
+Dwight D. Eisenhower Presidential Library and
+
+Abilene, Kansas
+
+Museum
+
+John F. Kennedy Presidential Library and
+
+Boston, Massachusetts
+
+Museum
+
+Lyndon Baines Johnson Library and Museum*
+
+Austin, Texas
+
+Richard Nixon Presidential Library and Museum
+
+Yorba Linda, California
+
+Gerald R. Ford Presidential Library and
+
+Ann Arbor, Michigan
+
+Museum*
+
+Jimmy Carter Library and Museum
+
+Atlanta, Georgia
+
+Ronald Reagan Presidential Library and Museum
+
+Simi Valley, California
+
+George Bush Presidential Library and Museum*
+
+College Station, Texas
+
+William J. Clinton Presidential Library and
+
+Little Rock, Arkansas
+
+Museum
+
+George W. Bush Presidential Library*
+
+Dallas, Texas
+
+Source: Herbert Hoover Presidential Library and Museum,
+ http://www.hoover.archives.gov/; Franklin D. Roosevelt Presidential
+Library and Museum, http://www.fdrlibrary.marist.edu/; Harry S. Truman
+Library and Museum, http://www.trumanlibrary.org/; Dwight D.
+Eisenhower Presidential Library and Museum,
+ http://www.eisenhower.archives.gov/; John F. Kennedy Presidential
+Library and Museum, http://www.jfklibrary.org/; Lyndon Baines Johnson
+Library and Museum, http://www.lbjlibrary.org/ ; Nixon Presidential
+Library and Museum, http://www.nixonlibrary.gov/index.php; Gerald R.
+Ford Presidential Library and Museum,
+ http://www.fordlibrarymuseum.gov/; Jimmy Carter Library and Museum,
+ http://www.jimmycarterlibrary.gov/; Ronald Reagan Presidential Library
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+Metropolitan School Desegregation
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+Interstate Natural Gas Pipeline Siting: 
+FERC Policy and Issues for Congress 
+
+Updated May 27, 2021 
+
+ Congressional Research Service 
+
+https://crsreports.congress.gov 
+
+R45239 
+
+ 
+
+ 
+
+ 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Summary 
+ Growth in U.S. shale gas production has driven the development of natural gas pipelines from 
+producing regions to consuming markets, typically in different states. If long-term growth trends 
+in U.S. shale gas continue, the need for new pipelines could be substantial. One recent analysis by 
+the pipeline industry projected over 30 billion cubic feet per day of new pipeline capacity would 
+be needed through 2025. This new infrastructure could amount to several thousand miles of 
+additional interstate pipeline and on the order of $40 billion in capital investment. 
+
+Under the Natural Gas Act, companies seeking to build interstate natural gas pipelines must first 
+obtain certificates of public convenience and necessity from the Federal Energy Regulatory 
+Commission (FERC). The commission’s regulatory process for certificate applications consists of 
+pre-filing, certificate application, application review (including environmental and other agency 
+review), authorization, and post-certificate proceedings. Several aspects of FERC’s review 
+practices are of interest to policymakers because they have been the subject of FERC dissent, 
+debate in Congress, or litigation. Key challenges to FERC certification involve environmental 
+impact assessment, evaluating project need, review timing, relations with other agencies, changes 
+in industry structure, export issues, environmental justice, and public participation in review. 
+
+The Bush, Obama, Trump, and Biden Administrations issued a series of executive orders intended 
+to change federal permitting of infrastructure, specifically including energy infrastructure. 
+Exactly how all of these orders have affected, or may affect, federal review of natural gas pipeline 
+siting is not clear. For example, in 2018, FERC signed a memorandum of understanding with 
+other federal agencies to meet the goals in President Trump’s E.O. 13807 “of reducing the time to 
+two years for each agency to complete all environmental reviews and authorization decisions for 
+major infrastructure projects.” However, President Biden revoked this executive order. 
+
+Pipeline expansion has prompted numerous congressional hearings and legislative proposals 
+regarding the federal role in pipeline siting. At least seven related bills have been introduced in 
+the 117th Congress, including the Promoting Interagency Coordination for Review of Natural Gas 
+Pipelines Act (H.R. 1616), the Safe and Accountable Federal Energy Review for Pipelines Act of 
+2021 (H.R. 2115), the CLEAN Future Act (H.R. 1512), the Environmental Justice Mapping and 
+Data Collection Act of 2021 (H.R. 516), the Ending Natural Gas Companies’ Seizure of Land for 
+Export Profits Act (S. 655), and the Landowner Fairness Act (S. 641), and H.R. 2889. 
+
+On February 18, 2021, FERC published a Notice of Inquiry (NOI) to reconsider its policies and 
+procedures for the certification of interstate natural gas pipelines. The 2021 NOI reopens a policy 
+inquiry originally initiated in 2018. The commission’s 2021 inquiry solicits additional 
+information and stakeholder perspectives about five aspects of certificate application review: 
+determination of project need, eminent domain and landowner interests, environmental impacts, 
+efficiency of the commission’s review process, and consideration of effects on environmental 
+justice communities. FERC’s inquiry was opened for public comments through May 26, 2021. 
+The commission has not stated any official timetable for completing this proceeding. 
+
+FERC’s NOI covers key congressional concerns as well as issues arising in certificate review 
+proceedings and litigation. Therefore, while FERC’s policy review does not guarantee any 
+changes to the gas pipeline certification status quo, it may provide valuable information and 
+context for congressional oversight. If Congress disagrees with FERC’s future policy choices 
+based on the findings of its NOI, those findings presumably would provide a basis and policy 
+context for subsequent legislative proposals. FERC’s policy options are limited to those aspects 
+of gas pipeline regulation which fall directly within the commission’s statutory authority under 
+the Natural Gas Act or within its discretion under other federal statutes. 
+
+Congressional Research Service 
+
+ 
+ link to page 5 link to page 6 link to page 8 link to page 8 link to page 9 link to page 10 link to page 11 link to page 12 link to page 12 link to page 13 link to page 14 link to page 15 link to page 18 link to page 18 link to page 19 link to page 19 link to page 20 link to page 20 link to page 21 link to page 21 link to page 22 link to page 22 link to page 23 link to page 23 link to page 24 link to page 24 link to page 25 link to page 25 link to page 26 link to page 27 link to page 28 link to page 30 link to page 7 link to page 8 link to page 17 link to page 25 link to page 30 Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Contents 
+
+ Introduction ..................................................................................................................................... 1 
+ A Growing Gas Pipeline Network ................................................................................................... 2 
+ FERC Pipeline Certification Process ............................................................................................... 4 
+
+ Application Pre-Filing ............................................................................................................... 4 
+ Certificate Application and FERC Review ............................................................................... 5 
+
+ Environmental Review Under NEPA.................................................................................. 6 
+
+ Certificate Authorities ............................................................................................................... 7 
+ Post-Certificate Proceedings ..................................................................................................... 8 
+
+ Gas Pipeline Siting Challenges ....................................................................................................... 8 
+
+ Identifying Indirect Environmental Impacts ............................................................................. 9 
+ Evaluating Project Need .......................................................................................................... 10 
+ Timing and Relations with Other Agencies ............................................................................. 11 
+ Changes in the Natural Gas Industry Structure ....................................................................... 14 
+Pipeline Infrastructure for Export ........................................................................................... 14 
+ Environmental Justice ............................................................................................................. 15 
+Public Participation ................................................................................................................. 15 
+
+ Recent Executive Orders ............................................................................................................... 16 
+
+ Executive Order 13212 ........................................................................................................... 16 
+ Executive Order 13604 ........................................................................................................... 17 
+Executive Order 13766 ........................................................................................................... 17 
+ Executive Order 13777 ........................................................................................................... 18 
+Executive Order 13783 ........................................................................................................... 18 
+ Executive Order 13807 ........................................................................................................... 19 
+Executive Order 13868 ........................................................................................................... 19 
+ Executive Orders 13990, 13992, and 14008 ........................................................................... 20 
+
+ Legislative Proposals ..................................................................................................................... 20 
+
+ Proposals in Prior Congresses ................................................................................................. 21 
+Legislative Proposals in the 117th Congress ............................................................................ 21 
+
+ FERC’s Policy Review .................................................................................................................. 22 
+
+ Reopening the Policy Review ................................................................................................. 23 
+
+ Policy Issues for Congress............................................................................................................. 24 
+ Appendix: Past FERC Permit Legislative Proposals ..................................................................... 26 
+
+ 
+
+ Figures 
+ Figure 1. U.S. Interstate Natural Gas Pipeline System .................................................................... 3 
+ Figure 2. U.S. Natural Gas Transmission Pipeline Mileage Additions ........................................... 4 
+ Figure 3. Review Time for FERC Certificate, Pipelines over 20 Miles Long ............................... 13 
+ 
+
+ Tables 
+ Table 1. Current Legislative Proposals Involving FERC Certification of Pipelines ..................... 21 
+ Table 2.Past Legislative Proposals to Change FERC Certification of Pipelines ........................... 26 
+
+Congressional Research Service 
+
+ 
+ link to page 34 Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ 
+
+ Contacts 
+ Author Information ........................................................................................................................ 30 
+ 
+ 
+
+Congressional Research Service 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Introduction 
+ On February 18, 2021, the Federal Energy Regulatory Commission (FERC) published a Notice of 
+Inquiry (NOI) to reconsider its policies and procedures for the certification (permitting) of 
+interstate natural gas pipelines.1 The 2021 NOI solicits new information and additional 
+stakeholder perspectives regarding the commission’s review of its pipeline certification policies, 
+which was originally initiated in 2018.2 This policy review included a 2018 public comment 
+period, but the commission took no further action.3 The 2021 NOI effectively reopens the 2018 
+proceeding under a new FERC chairman and three (of five) new commissioners. 
+
+Expansion of the U.S. natural gas pipeline network has been an ongoing focus of Congress, 
+prompting numerous hearings and legislative proposals over the last decade regarding the federal 
+role in interstate natural gas pipeline siting. Several related bills have been introduced in the 117th 
+Congress through May 2021, including the Promoting Interagency Coordination for Review of 
+Natural Gas Pipelines Act (H.R. 1616), the Safe and Accountable Federal Energy Review for 
+Pipelines Act of 2021 (H.R. 2115), the CLEAN Future Act (H.R. 1512), the Environmental 
+Justice Mapping and Data Collection Act of 2021 (H.R. 516), the Ending Natural Gas 
+Companies’ Seizure of Land for Export Profits Act (S. 655), the Landowner Fairness Act (S. 
+641), and a bill to amend the Natural Gas Act with respect to actions for eminent domain by 
+holders of certificates of public convenience and necessity, and for other purposes (H.R. 2889). 
+
+FERC’s NOI is in the continuation a series of legislative proposals, executive orders, court 
+rulings, and commission orders which address the federal regulation of gas pipeline permitting. 
+FERC’s inquiry provides both advocates and opponents of gas pipeline development a new 
+opportunity to express their views about how the commission considers such projects. It may also 
+identify issues of focus for future congressional oversight and legislation. Given that the United 
+States is the world’s largest producer of natural gas,4 policy changes by FERC affecting natural 
+gas infrastructure could have significant implications for U.S. natural gas resource development, 
+prices, and associated environmental and social impacts. Therefore, they are the subject of 
+scrutiny within Congress and among a wide range of stakeholders.5 
+
+This report provides an overview of the federal certification process for interstate natural gas 
+pipelines and recent policy issues which have been the subject of debate, legislation, and 
+litigation. It reviews recent executive orders intended to influence federal approval of natural gas 
+pipeline projects. The report summarizes legislation proposed in the 117th Congress (and prior 
+Congresses in the Appendix ) directed at the federal review of interstate natural gas pipeline 
+certificate applications. It also summarizes FERC’s inquiry regarding of its policy statement for 
+natural gas pipeline certification, which serves as the basis of its review of pipeline certificate 
+applications. The report concludes with a discussion of policy issues for Congress. 
+
+ 
+1 Federal Energy Regulatory Commission (FERC), Certification of New Interstate Natural Gas Facilities, Notice of 
+Inquiry, Docket No. PL18-1-000, February 18, 2021. (Hereinafter, FERC 2021 NOI.) 
+
+2 FERC, Certification of New Interstate Natural Gas Facilities , Notice of Inquiry, Docket No. PL18-1-000, April 19, 
+2018. (Hereinafter, FERC 2018 NOI.) 
+
+3 Richard Glick, FERC Chairman, letter to the Honorable Joe Manchin III, United States Senate, May 21, 2021. 
+4 BP, Statistical Review of World Energy 2020 , 2020, p. 34. 
+5 See, for example, U.S. Senator John Hoeven et al., letter to the Honorable Richard Glick, Chairman, et al., FERC, 
+April 29, 2021. “The Commission’s Policy Statement is critical to the advancement of important natural gas 
+infrastructure projects.” 
+
+Congressional Research Service 
+
+ 
+
+1 
+
+ 
+ link to page 7 Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ A Growing Gas Pipeline Network 
+ The United States’ supply of natural gas has grown substantially due to technological 
+advancements, such as horizontal drilling and hydraulic fracturing, which have increased 
+producers’ ability to extract natural gas from shale formations. Shale gas is now the dominant 
+source of U.S. natural gas supply.6 The continued growth in U.S. shale gas production to meet 
+growing demand in key consuming sectors has been driving the expansion of natural gas pipeline 
+infrastructure at the local level (to gather and process the gas) and at the national level to 
+transport natural gas from producing regions to consuming markets, typically in other states. Over 
+300,000 miles of high-capacity transmission pipeline already transport natural gas across the 
+United States ( Figure 1 ) .7 However, even considering a reduction in demand following the global 
+COVID-19 pandemic, if long-term growth trends in U.S. shale gas production and demand 
+continue, the need for new pipelines could still be substantial. One recent analysis by the INGAA 
+Foundation, a pipeline industry research organization, concluded 
+
+As the impacts of COVID-19 diminish over time, the drivers of new infrastructure return.... 
+[A]lmost 33 billion cubic feet (BCF) per day of capacity is expected to be placed into 
+service through major gas pipeline projects from 2020 through 2025.8 
+
+This new infrastructure could amount to several thousand miles of additional interstate pipeline 
+and on the order of $40 billion in additional capital investment.9 
+
+ 
+6 U.S. Energy Information Administration, Annual Energy Outlook 2021 , “U.S. Dry Natural Gas Production by Type,” 
+February 3, 2021, https://www.eia.gov/outlooks/aeo/pdf/03%20AEO2021%20Natural%20gas.pdf. 
+
+7 Pipeline and Hazardous Materials Safety Administration, “Annual Report Mileage for Natural Gas Transmission and 
+Gathering Systems,” web page, March 1, 2021, https://www.phmsa.dot.gov/data-and-statistics/pipeline/annual-report-
+mileage-natural-gas-transmission-gathering-systems. 
+
+8 INGAA Foundation, North American Midstream Infrastructure—A Near Term Update Through 2025, December 
+2020, p. 55. The INGAA Foundation is affiliated with the Interstate Natural Gas Association of America (INGAA), the 
+interstate gas pipeline industry trade association. 
+
+9 Ibid, and INGAA Foundation, “North American Midstream Infrastructure Through 2035: Significant Development 
+Continues,” June 18, 2018, p. 48. The mileage and capital investment values are CRS estimates based on data in the 
+INGAA Foundation reports. 
+
+Congressional Research Service 
+
+ 
+
+2 
+
+ 
+ link to page 8 
+
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Figure 1. U.S. Interstate Natural Gas Pipeline System 
+
+ 
+
+ Source: U.S. Energy Information Administration. “U.S. Energy Mapping System,” online maps, accessed March 
+18, 2021, https://www.eia.gov/state/maps.php. 
+
+ Figure 2 shows annual additions to natural gas transmission pipeline mileage in the United States 
+since 2004. As the figure indicates, federal and state agencies have approved significant additions 
+to the pipeline system over these years, especially after the onset of the shale gas expansion in 
+2006-2008. Pipeline construction slowed for a five-year period through 2016 as newly added 
+capacity absorbed new shale gas supplies, but construction increased again from 2017 to 2020. 
+Altogether, over 23,500 miles of newly constructed gas transmission pipeline have begun service 
+since 2004. Additional gas pipeline capacity has also become available through conversion of 
+pipelines carrying other commodities or flow reversal of existing natural gas pipelines. Over 
+1,500 miles of pipeline have been permitted or are under construction with startup anticipated in 
+2021, although anticipated additions fall sharply in 2022. 
+
+Congressional Research Service 
+
+ 
+
+3 
+
+ 
+ 
+
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Figure 2. U.S. Natural Gas Transmission Pipeline Mileage Additions 
+
+(Miles) 
+
+ 
+
+ Source: Energy Information Administration (EIA), “U.S. Natural Gas Pipeline Projects,” online spreadsheet, 
+January 28, 2021, https://www.eia.gov/naturalgas/data.cfm#pipelines. 
+ Notes: Excludes reversal and conversion projects as well as gathering and distribution lines. Anticipated projects 
+in 2021 and 2022 include approved projects and projects under construction but excludes projects “on hold.” 
+Includes some state-regulated (intrastate) pipelines. EIA figures are based on the agency’s analysis of regulatory 
+filings and industry reports. 
+
+ FERC Pipeline Certification Process 
+ Under Section 7(c) of the Natural Gas Act of 1938 (NGA), FERC is authorized to issue 
+certificates of “public convenience and necessity” for “the construction or extension of any 
+facilities ... for the transportation in interstate commerce of natural gas” (15 U.S.C. §717f(c)). 
+Therefore, companies seeking to build interstate natural gas pipelines must first obtain certificates 
+of public convenience and necessity from FERC.10 The commission’s regulatory process for the 
+review of certificate applications consists of several principal steps, explained below, which may 
+vary somewhat depending upon whether or not a pipeline developer opts to enter into a voluntary 
+pre-filing process before formally applying for a pipeline certificate. 
+
+ Application Pre-Filing 
+ Prior to applying to FERC for a pipeline certificate, developers may file a request to use the 
+commission’s pre-filing procedures (18 C.F.R. §157.21). The commission established the pre-
+filing process to encourage the industry to engage early in project development with the relevant 
+public and government agencies. The expectation is that the pre-filing will improve a developer’s 
+proposal and avoid problems during the review of a subsequent FERC certificate application. 
+However, while FERC encourages pre-filing, it is not required to apply for a pipeline certificate. 
+
+ 
+10 FERC must also approve the abandonment of gas facility use and services. The commission does not have similar 
+siting authority over oil pipelines, nor over natural gas pipelines located entirely within a state’s borders not involved in 
+interstate commerce. Siting of oil and intra state natural gas pipelines is, instead, variously regulated by the states. 
+
+Congressional Research Service 
+
+ 
+
+4 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+The pre-filing process involves a set of specific activities by the developer—typically studying 
+potential project sites, identifying stakeholders, and holding an open house to discuss the project. 
+Through this process, a developer notifies all stakeholders—including tribal, state, local, and 
+other federal agencies, and potentially affected property owners—about a proposed project so that 
+the developer and commission staff can provide public forums to hear stakeholder concerns. The 
+pipeline developer may then incorporate proposed environmental mitigation measures into the 
+project design, taking into account stakeholder input. Concurrent with the developer’s activities, 
+FERC staff participate in public forums and take steps necessary to ensure FERC compliance 
+with the National Environmental Policy Act (NEPA, discussed below). For example, FERC 
+consults with interested stakeholders, including relevant government agencies, and also holds 
+public scoping meetings and site visits in the proposed project area.11 At the conclusion of pre-
+filing, the developer prepares a final application and submits it to FERC. 
+
+ Certificate Application and FERC Review 
+ Whether pre-filing or not, a pipeline developer must formally apply to FERC for a certificate of 
+public convenience and necessity. Among other requirements, the application must contain a 
+description of the proposed pipeline, route maps, construction plans, schedules, and a list of other 
+statutory and regulatory requirements, such as permits needed from other agencies. The 
+application must also include environmental reports analyzing route alternatives—to avoid or 
+minimize environmental damage—and studies of potential environmental impacts (on water, 
+plants, and wildlife), cultural resources, socioeconomics, soils, geology, aesthetic resources, and 
+land use.12 Upon receiving an application, the commission issues a public Notice of Application 
+in the Federal Register and begins the application review process. 
+
+Any person seeking to become a party to FERC’s proceeding must file a motion to intervene 
+pursuant to the commission’s rules (18 C.F.R. §385.214). Intervenors receive the certificate 
+applicant’s filings and other FERC documents related to the case, as well as materials filed by 
+other interested parties.13 Only intervenors have the right to file briefs, attend hearings, and appeal 
+the commission’s decision regarding the certificate. They may also challenge final commission 
+actions in the U.S. Circuit Courts of Appeal. 
+
+FERC currently exercises its NGA Section 7(c) pipeline certification authority in accordance with 
+its own regulations and the guidance of its 1999 Policy Statement on Certification of New 
+Interstate Natural Gas Pipeline Facilities .14 The statement lays out FERC’s “policy for 
+determining whether there is a need for a specific project and whether, on balance, the project 
+will serve the public interest.”15 It also outlines a “flexible balancing process” within which the 
+commission considers market support; economic, operational, and competitive benefits; and 
+
+ 
+11 For a flowchart of steps taken by both FERC and certificate applicants, see FERC, “EIS Pre-Filing Environmental 
+Review Process,” web page, June 25, 2020, https://www.ferc.gov/resources/processes/flow/process-eis. 
+
+12 During the review process, FERC, or any intervenor or public commenter, may suggest additional siting alternatives 
+and modifications to reduce impacts on buildings, fences, crops, water supplies, soil, vegetation, wildlife, air quality, 
+noise, safety, landowner interests, etc. Commission staff also consider whether a proposed pipeline can be placed near 
+or within the right-of-way of an existing pipeline, power line, highway, or railroad. See FERC, An Interstate Natural 
+Gas Facility on My Land? , August 2015, p. 8. 
+
+13 Intervenors are also obligated to mail copies of their own filings to all other parties to the proceeding. 
+14 18 C.F.R. Part 157. 
+15 FERC, Certification of New Interstate Natural Gas Pipeline Facilities: Statement of Policy, 88 FERC ¶ 61,227, 
+Docket No. -000, September 15, 1999. 
+
+Congressional Research Service 
+
+ 
+
+5 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+environmental impact, among other considerations.16 Economic factors FERC examines include a 
+project’s potential impact on pipeline competition, the possibility of overbuilding, subsidization 
+by existing customers, acquiring rights-of-way (including the use of eminent domain), and other 
+considerations.17 FERC may also take into account safety issues, but generally defers to the 
+Department of Transportation, which regulates pipeline safety.18 Of the factors above, 
+environmental review typically has comprised the bulk of FERC’s certificate application review. 
+
+ Environmental Review Under NEPA 
+
+Before FERC can issue a final decision on an application, the agency must identify and consider 
+the environmental impacts of the proposed project in accordance with NEPA (42 U.S.C. §4321 et 
+seq.). NEPA requires federal agencies to “take a hard look at environmental consequences” of 
+their proposed actions (e.g., granting a certificate), consider alternatives, and publicly disseminate 
+such information before taking final action.19 Although an agency must consider these impacts, it 
+need not elevate these environmental concerns above others. Under NEPA, federal agencies must 
+prepare an environmental impact statement (EIS) for federal actions “significantly affecting the 
+quality of the human environment.”20 
+
+NEPA also established the Council on Environmental Quality (CEQ), which issues regulations 
+and guidance detailing how federal agencies must implement NEPA.21 CEQ’s guidance has 
+included, for example, guidance on consideration of greenhouse gas emissions and the effects of 
+climate change (discussed below). In its regulations, CEQ has directed each federal agency to 
+adopt and supplement the CEQ regulations as necessary to include procedures relevant to that 
+agency’s authority and ensure that the procedures implementing NEPA are integrated into the 
+agency’s broader decisionmaking process. Accordingly, FERC has promulgated its own 
+regulations implementing NEPA at 18 C.F.R. §380. 
+
+The CEQ regulations focus primarily on requirements applicable to the preparation of an EIS, but 
+recognize that documenting compliance with NEPA may involve other procedures. If an agency is 
+uncertain whether a proposal would have significant impacts, it may prepare an environmental 
+assessment (EA) to determine if an EIS is necessary or a finding of no significant impact 
+(FONSI) may be issued. Also, each federal agency is required to identify categories of actions 
+they are authorized to undertake that have been found to have no significant effect on the 
+
+ 
+16 88 FERC ¶ 61,227, p. 14. 
+17 88 FERC ¶ 61,227 and orders clarifying policy, 90 FERC ¶ 61,128 and 92 FERC ¶ 61,094, 2000 as summarized in 
+Caroyln Elefant, “Knowing and Protecting Your Rights When an Interstate Gas Pipeline Comes to Your Community,” 
+white paper, Law Offices of Carolyn Elefant, Washington, DC, May 17, 2010, https://lawofficesofcarolynelefant.com/
+wp-content/uploads/2010/06/FINALTAGguide.pdf. 
+
+18 Pipeline safety regulations are covered in Title 49 of the Code of Federal Regulations. In granting pipeline 
+certificates, FERC requires that developers comply with DOT pipeline safety standards for design, construction, 
+operation, and maintenance. 
+
+19 Robertson v. Methow Valley Citizens Council , 490 U.S. 332, 350 (1989). 
+20 NEPA §102(2)(C); 42 U.S.C. §4332(2)(C). Of note, federal actions subject to NEPA are defined to include actions 
+that require federal agency approvals via a permit or other regulatory approval (40 C.F.R. §1508.18). For more NEPA 
+information, see CRS Report RL33152, The National Environmental Policy Act (NEPA): Background and 
+Implementation , by Linda Luther. 
+
+21 Council on Environmental Quality, “Regulations for Implementing the Procedural Provisions of the National 
+Environmental Policy Act,” in 40 C.F.R. Parts 1500-1508 (43 Federal Register 55990, November 28, 1978). 
+
+Congressional Research Service 
+
+ 
+
+6 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+environment. Such actions are categorically excluded from the need to prepare an EIS or EA and 
+are, hence, broadly referred to as “categorical exclusions” (CEs or CATEXs).22 
+
+CEQ requires agencies to determine whether a proposal has significant impacts by identifying 
+and analyzing its direct, indirect, and cumulative effects, defined as follows: 
+
+ Direct effects— caused by the project that occur at the same time and place;23 
+ Indirect effects— caused by the action that are later in time or farther removed in 
+
+distance but still reasonably foreseeable;24 and 
+
+ Cumulative effects— those that result from the incremental impacts of the action 
+
+when added to other past, present, or reasonably foreseeable future actions 
+regardless of what agency (federal or nonfederal) or person undertakes that other 
+action.25 
+
+The Energy Policy Act of 2005 (P.L. 109-58, EPAct) designates FERC as the “lead agency” for 
+coordinating NEPA compliance and “all applicable Federal authorizations” in reviewing pipeline 
+certificate applications (§313(b)). As the lead agency, FERC is required to obtain input from other 
+“cooperating” agencies with statutory jurisdiction or special expertise regarding any 
+environmental impact associated with the project (40 C.F.R. §1508.5). Cooperating agencies for a 
+pipeline project often include the Environmental Protection Agency; the Department of 
+Transportation’s Pipeline and Hazardous Materials Safety Administration; the Department of the 
+Interior’s Bureau of Land Management (BLM), Fish and Wildlife Service, and National Park 
+Service; and the U.S. Army Corps of Engineers (the Corps), among others. 
+
+After FERC staff complete their environmental analysis and cooperating agency consultations, 
+the commission issues a draft EIS with initial recommendations for approval or denial of the 
+certificate. Issuance of the draft EIS also begins a public comment period of at least 45 days, 
+during which FERC is to hold public meetings in the proposed project area.26 After the conclusion 
+of the comment period, FERC reviews the comments and revises its draft EIS in response. FERC 
+then issues a final EIS with final recommendations for approval or denial of the certificate. Under 
+NEPA, a record of decision—in this context a FERC order—cannot be issued until at least 30 
+days after FERC publishes a notice of availability of the final EIS (40 C.F.R. §1506.10(b)(2)). 
+However, there is no additional opportunity for public comment. When the 30-day period is over, 
+the commission may issue an order approving or denying the certificate. 
+
+ Certificate Authorities 
+ If FERC grants a pipeline certificate, the commission’s order states the terms and conditions of 
+the approval, including the authorized pipeline route and any construction or environmental 
+mitigation measures required for the project. For example, a construction condition might require 
+that the pipeline be buried at a specific depth under a particular river crossing, or that construction 
+be limited during a certain time of year to avoid impacts on wildlife. A FERC certificate confers 
+on the developer the authority to exercise the government’s eminent domain authority if certain 
+ 
+22 Each agency’s regulations implementing NEPA are required to provide for “extraordinary circumstances” in which a 
+normally excluded action may have significant environmental effect (40 C.F.R. §1508.4). 
+
+23 40 C.F.R. §1508.8(a). 
+24 40 C.F.R. §1508.8(b). In the definition of effects (at 40 C.F.R. §1508), it is noted that the words effects and impacts 
+are synonymous, as they are used in the CEQ regulations. 
+
+25 40 C.F.R. §1508.7. 
+26 FERC usually establishes a 45-day comment period, the minimum required under 40 C.F.R. §1506.10(c). In some 
+cases involving very large projects or complex environmental issues, FERC has established longer periods. 
+
+Congressional Research Service 
+
+ 
+
+7 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+conditions are met (15 U.S.C. §717f(h)). Also, federal law preempts any state or local law that 
+duplicates or obstructs that federal law (e.g., siting or zoning) relevant to the project. In this way, 
+a FERC certificate provides a developer with the authority to secure the necessary rights-of-way 
+to lay the pipeline if the developer cannot secure them from landowners through negotiation. 
+
+Although a FERC certificate authorizes a pipeline under the Natural Gas Act, it does not preempt 
+other federal laws that also may apply—such as the Endangered Species Act or the National 
+Historic Preservation Act. Any requirements under other federal statutes must still be met. These 
+requirements may include, for example, securing federal authorizations for water crossings from 
+the Corps, permission to cross federal lands from the BLM, and other federal approvals.27 
+Pipeline developers also may need to secure approvals from state agencies under delegated 
+federal authorities, such as Section 401 water quality certifications under the Clean Water Act (33 
+C.F.R. §330.4). A developer must secure all these approvals before proceeding with construction. 
+
+ Post-Certificate Proceedings 
+ Once FERC issues an order granting or denying a pipeline certificate, parties to the proceeding 
+(e.g., the developer or intervenors) who object to the order for any reason may formally request a 
+rehearing so that the commission can reconsider its decision. A party to the proceeding must file a 
+request for rehearing within 30 days after issuance of the final order—a statutory deadline which 
+the commission cannot waive or extend (15 U.S.C. §717(r)). Upon receiving a rehearing request, 
+FERC has 30 days to rule on it or the request is deemed denied, in either case allowing a party 
+involved to appeal FERC’s ruling in federal court.28 The commission, by its own order, may not 
+authorize pipeline construction to proceed until the earlier of either the date that a qualifying 
+rehearing request is no longer pending before the Commission or 90 days after the date that a 
+qualifying rehearing request may be deemed denied.29 If a pipeline certificate is approved after 
+rehearing, the pipeline project may proceed even if additional court challenges have been filed. 
+Once the developer has provided FERC with any outstanding information or taken other actions 
+to satisfy the terms and conditions of the certificate order FERC can issue a Notice to Proceed 
+with Construction Activities and construction can begin. The pipeline developer must then file 
+weekly status reports with the commission documenting project inspection and certificate 
+compliance until construction is completed. 
+
+ Gas Pipeline Siting Challenges 
+ Over the last decade, proposals for new interstate natural gas pipelines have become increasingly 
+controversial. Many certificate applications have been subjected to heavy public scrutiny, and 
+some have faced significant delays in review, as well as protracted litigation. A May 2018 report 
+by the Department of Energy Inspector General stated that “nothing came to our attention to 
+indicate that FERC had not generally performed the natural gas certification process in 
+
+ 
+27 For details about Corps approvals, see CRS Report R44880, Oil and Natural Gas Pipelines: Role of the U.S. Army 
+Corps of Engineers , by Nicole T. Carter et al. 
+
+28 This 30-day deadline was affirmed in a June 30, 2020, judgment by the United States Court of Appeals for the 
+District of Columbia Circuit in, a case which challenged FERC’s prior use of “tolling” orders to delay ruling on the 
+merits of certificate rehearing requests. Allegheny Defense Project v. FERC, 964 F. 3d 1 (D.C. Circuit Court of 
+Appeals, 2020). 
+
+29 171 FERC ¶ 61,201 and 175 FERC ¶ 61,098. The limit on construction authorization applies “only when a request 
+for rehearing raises issues reflecting opposition to project construction, operation, or need.” 
+
+Congressional Research Service 
+
+ 
+
+8 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+accordance with applicable laws, regulations, policies, and procedures.”30 Nonetheless, aspects of 
+FERC’s current practices remain a focus of attention among policymakers because they have 
+been the subject of FERC dissent, debate in Congress, or litigation in federal court. 
+
+ Identifying Indirect Environmental Impacts 
+ As noted above, FERC is obligated under NEPA to consider the direct and indirect environmental 
+impacts of certificate proposals. Direct effects often are relatively easy to identify. In the context 
+of a pipeline project, a direct effect would be associated with the pipeline itself, such as forest 
+impacts from clearing rights-of-way, or water quality impacts from construction across waterways 
+and wetlands. However, identifying the indirect effects of a proposed gas pipeline has presented 
+challenges and, in some cases, has been controversial. Some stakeholders assert that the indirect 
+“upstream” impacts of a proposed pipeline should include impacts associated with the production 
+of natural gas, such as fugitive methane emissions from gas wells and gas gathering pipelines. 
+They also assert that the indirect “downstream” impacts should include the environmental effects 
+of using natural gas, such as carbon dioxide emissions from natural gas combustion.31 
+
+In the past, FERC limited its review of certain upstream or downstream impacts, claiming that 
+they were not reasonably foreseeable. However, in February 2017, a FERC commissioner argued 
+that FERC should analyze the upstream environmental effects of increased natural gas production 
+and should be “open to analyzing the downstream impacts of the use of natural gas.”32 In a related 
+legal challenge to a pipeline (Sabal Trail) in Florida for which the effects of natural gas use could 
+be identified, the court ruled that FERC must “either quantify and consider the project’s 
+downstream carbon emissions or explain in more detail why it cannot do so.”33 
+
+In FERC’s 2018 order responding to the Sabal Trail ruling, the majority of commissioners 
+concluded that, although its supplemental EIS quantified downstream greenhouse gas emissions 
+associated with the pipeline, there was “no way to determine the significance” of those 
+emissions.34 However, two commissioners raised objections to the majority’s conclusion, arguing 
+that the significance of the downstream greenhouse gas emissions could—and should—be 
+quantified.35 In an unrelated FERC order involving a pipeline in New York, the majority stated 
+that they were “unable to find based on the record that the potential increase in greenhouse gas 
+emissions associated with production, non-project transport, and non-project combustion are 
+causally related” to the commission’s certification of the project, and that “providing a broad 
+analysis based on generalized assumptions rather than reasonably specific information does not 
+meaningfully inform the Commission’s project-specific review.”36 The two commissioners 
+dissented from this conclusion as well, one arguing that “the mere fact that the record does not 
+contain specific information regarding the greenhouse gas emissions associated with increased 
+ 
+30 U.S. Department of Energy, Office of Inspector General, The Federal Energy Regulatory Commission’s Natural Gas 
+Certification Process , Audit Report, DOE-OIG-18-33, May 2018, p. 1. The report did identify four areas for 
+improvement: process transparency, public access to FERC records, tracking stakeholder comments, and data integrity. 
+
+31 See, for example, Sierra Club, “FERC Further Abdicates Its Obligations in Favor of More Pollution,” press release, 
+May 18, 2018. 
+
+32 FERC, Order Granting Abandonment and Issuing Certificates , 158 FERC ¶ 61,145, Docket Nos. CP15-115-000 and 
+CP-15-115-001, Commissioner Bay, Separate Statement, February 3, 2017, p. 5. 
+
+33 Sierra Club, et al . vs. FERC, 857 F.3d 1357, 1375 (D.C. Cir. 2017). 
+34 FERC, Order on Remand Reinstating Certificate and Abandonment Authorization, 162 FERC ¶ 61,233, Docket Nos. 
+CP14-554-002, CP15-16-003, and CP15-17-002, March 14, 2018, p. 25. 
+
+35 Ibid., “LaFLEUR, Commissioner, dissenting in part,” p. 2, and “GLICK, Commissioner, dissenting,” p. 5. 
+36 FERC, Order Denying Rehearing , Docket No. CP14-497-001, 163 FERC ¶ 61,128, May 18, 2018. 
+
+Congressional Research Service 
+
+ 
+
+9 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+production or consumption from a particular natural gas pipeline cannot excuse the Commission 
+from considering those effects under NEPA.”37 
+
+Litigation related to FERC’s environmental reviews has continued—as has disagreement among 
+commissioners about the proper scope of environmental impacts for pipelines under FERC’s 
+jurisdiction. For example, in a 2019 legal challenge involving FERC’s approval of a new natural 
+gas pipeline compressor station, while upholding FERC’s approval, the court nonetheless was 
+critical of FERC’s examination of both upstream and downstream greenhouse gas emissions 
+associated with the project.38 In a 2020 FERC order approving another gas pipeline project, 
+concurring and dissenting opinions by two commissioners, respectively, expanded upon their 
+prior support for, or rejection of, FERC’s treatment of greenhouse gas emissions in environmental 
+reviews.39 In March 2021, FERC announced that it had “for the first time assessed the 
+significance of a proposed natural gas pipeline project’s greenhouse gas emissions and their 
+contribution to climate change.”40 The associated certificate order (approving Northern Natural 
+Gas Company pipeline facilities) states 
+
+In previous orders, the Commission has concluded that it was unable to assess the 
+significance of a project’s greenhouse gas (GHG) emissions or those emissions’ 
+contribution to climate change. Upon reconsideration, we no longer believe that to be the 
+case. Accordingly ... we assess the significance of the project’s GHG emissions and their 
+contribution to climate change. Based on the record in this proceeding, we conclude that 
+those impacts are not significant.41 
+
+However, adopting this approach was not unanimous. While concurring with the approval of the 
+pipeline project, two commissioners dissented (in part) with respect to the greenhouse gas 
+assessment on legal grounds or because they believed that FERC’s change in approach was 
+premature.42 
+
+ Evaluating Project Need 
+ FERC’s review of a certificate application requires the commission to evaluate the public benefit 
+from the proposed project. Benefits the commission may consider include meeting unserved 
+demand, eliminating pipeline bottlenecks, accessing new gas supplies, lowering consumer costs, 
+providing greater reliability, and increasing competition, among others. A principal component of 
+this evaluation is demonstrated market need for the pipeline in the form of contracts with future 
+customers for its capacity. As FERC’s current policy states, 
+
+a new pipeline project must show market support through contractual commitments for at 
+least 25 percent of the capacity for the application to be processed by the Commission. An 
+applicant showing 10-year firm commitments for all of its capacity, and/or that revenues 
+will exceed costs is eligible to receive a traditional certificate of public convenience and 
+necessity.43 
+
+ 
+37 Ibid., “GLICK, Commissioner, dissenting in part,” p. 7. 
+38 Birckhead vs. FERC, 925 F. 3d 510 (D.C. Cir. 2019). 
+39 172 FERC ¶ 61,039. 
+40 FERC, “FERC Reaches Compromise on Greenhouse Gas Significance,” press release, March 18, 2021. 
+41 174 FERC ¶ 61,189, p. 11. 
+42 Ibid. 
+43 88 FERC ¶ 61,227, p. 14. 
+
+Congressional Research Service 
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+ 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+Some stakeholders have questioned FERC’s reliance on contracts from future customers (known 
+as “precedent agreements”) to prove market need, particularly when those contracts involve 
+companies affiliated with the pipeline developer. The commission considered this concern in 
+1999 but established no special provisions for developer affiliates. FERC “gives equal weight to 
+contracts between an applicant and its affiliates and an applicant and unrelated third parties and 
+does not look behind the contracts to determine whether the customer commitments represent 
+genuine growth in market demand.”44 Nonetheless, in January 2018 one FERC commissioner 
+dissented from the approval of a certificate because over three-quarters of the pipeline’s capacity 
+under precedent agreements was associated with affiliates, and was therefore “insufficient to 
+carry the developer’s burden to show that the pipeline is needed.”45 
+
+In remarks at a February 13, 2018, meeting of state utility regulators, the FERC chairman stated 
+that the commission would “have to take a look at” whether recent precedent agreements, and 
+particularly affiliate agreements, represent “valid, arm’s length” demonstrations of pipeline 
+capacity demand.46 However, an April 2020 order denying a request for certificate rehearing 
+reaffirmed the commission’s reliance upon precedent agreements, asserting that such agreements 
+“are significant evidence of demand for a project,” and that FERC is not required to assess project 
+benefits “by looking beyond the market need reflected by the applicant’s precedent agreements 
+with shippers.”47 
+
+Also related to the issue of market need, some stakeholders have objected to FERC’s project-by-
+project approach to evaluating applications—especially for multiple pipelines proposed in one 
+region.48 Some in Congress have called on FERC to adopt a more overarching approach to 
+pipeline development, collectively considering existing capacity and multiple projects together 
+rather evaluating them independently.49 However, FERC has maintained that it “does not engage 
+in regional planning exercises that would result in the selection of one project over another.”50 
+Nonetheless, in October 2017 one FERC commissioner dissented from the approval of two 
+pipelines through Virginia on the grounds that both projects might not be needed due to 
+geographic proximity.51 
+
+ Timing and Relations with Other Agencies 
+ There are no statutory time limits within which FERC must complete its own certificate review 
+process or issue an order. However, EPAct authorizes FERC to establish a schedule for all federal 
+
+ 
+44 88 FERC ¶ 61,227, p. 15. 
+45 FERC, “Statement of Commissioner Richard Glick on the PennEast Project,” Docket No. CP15-558-000, January 19, 
+2018, https://www.ferc.gov/media/statements-speeches/glick/2018/01-19-18-glick.pdf. 
+
+46 Kevin McIntyre, FERC Chairman, remarks before the National Association of Regulatory Utility Commissioners, 
+February 13, 2018, https://www.facebook.com/NARUCToday/videos/2025186407497968/?rc=p. 
+
+47 171 FERC ¶ 61,049, pp. 5-6. 
+48 FERC, Roanoke County’s Motion to Intervene and Identification of Issues , Docket Nos. CP16-10-000 and CP16-13-
+000, November 24, 2015, p. 6. 
+
+49 See, for example, U.S. Representative Bonnie Watson Coleman, “Watson Coleman, Malinowski Introduce Bill to 
+Ensure Full Reviews of Proposed Pipelines,” press release, March 31, 2021; and Duncan Adams, “Senators Hope to 
+Compel FERC to Broaden Analysis of Pipeline Projects,” The Roanoke Times , February 4, 2016. 
+50 Tamara Young-Allen, FERC, as quoted in: “Feds Reject Consolidated Review of Pipeline Projects,” Associated 
+Press , December 10, 2015. 
+
+51 FERC, “Statement of Commissioner Cheryl A. LaFleur on Order Issuing Certificates and Granting Abandonment 
+Authority,” Docket No. CP16-10-000, October 13, 2017, https://www.ferc.gov/media/statements-speeches/lafleur/
+2017/10-13-17-lafleur.pdf. 
+
+Congressional Research Service 
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+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
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+
+authorizations and creates a cause of action “if a Federal or State administrative agency” fails to 
+comply with that schedule (§313(b)). As discussed above, natural gas pipelines typically require 
+permits from federal and state agencies in addition to FERC. Since 2002, FERC and nine other 
+federal agencies have operated under an interagency agreement on early coordination required for 
+review of interstate natural gas pipeline certificate applications.52 Under this agreement, when 
+FERC receives a certificate application, the agencies commit to early involvement, proactive 
+participation, sharing of data, informal communication, and resolving disputes. FERC has 
+promulgated regulations under the EPAct authority requiring certificate-related final decisions 
+from federal agencies or state agencies (acting under delegated federal authority) no later than 90 
+days after the commission issues its final environmental document, unless another schedule is 
+established by federal law (18 C.F.R §157.22). 
+
+Congress included the schedule provisions in EPAct to address concerns that some interstate gas 
+pipeline approvals were being unduly delayed by a lack of coordination or insufficient action 
+among agencies involved in the certification process.53 Notwithstanding the directives above, 
+pipeline developers have asserted that cooperating federal agencies have not always coordinated 
+effectively with FERC in its review of certificate applications and have not always complied with 
+FERC’s deadlines.54 For example, a 2012 study by the INGAA Foundation concluded that, 
+despite the schedule provisions in EPAct intended to expedite the review of FERC certificate 
+applications for gas pipelines, “the time required to secure regulatory approvals for such projects 
+is increasing.”55 Likewise, some in Congress have argued that gas pipeline reviews have been 
+“delayed unnecessarily due to a lack of coordination or insufficient action among agencies 
+involved.”56 Subsequent debate in congressional hearings about the timing of FERC’s certificate 
+reviews indicated both criticism of and support for FERC’s process.57 In the 116th Congress, there 
+was relatively less focus on the duration of FERC’s permit reviews compared to other aspects of 
+FERC’s certification process, but the length of permit review, and project delays due to 
+subsequent challenges to FERC reviews, remain a key interest among developers and in 
+Congress.58 
+
+FERC staff have stated that the commission seeks to complete review of certificate applications 
+within 18 to 24 months of filing.59 A review of certificate approvals for larger pipeline projects 
+over the last decade indicates that FERC has generally, but not always, met a 24-month review 
+
+ 
+52 FERC et al., “Interagency Agreement on Early Coordination of Required Environmental and Historic Preservation 
+Reviews Conducted in Conjunction with the Issuance of Authorizations to Construct and Operate Interstate Natural 
+Gas Pipelines Certificated by the Federal Energy Regulatory Commission,” May 2002; See also 42 U.S.C. §15928(b). 
+
+53 Senate Committee on Environment and Public Works, Oversight Hearing to Review the Permitting of Energy 
+Projects, S. Hrg. 109-856, May 25, 2005. 
+
+54 See, for example, Interstate Natural Gas Association of America, “INGAA Comments on United States Army Corps 
+of Engineers; Subgroup of the Department of Defense Regulatory Reform Task Force, Review of Existing Rules,” 82 
+Fed. Reg. 33,470 (July 20, 2017); Docket ID No. COE-2017-0004,” October 18, 2017, p. 3, http://www.ingaa.org/
+File.aspx?id=33450. 
+
+55 INGAA Foundation, Expedited Federal Authorization of Interstate Natural Gas Pipelines: Are Agencies Complying 
+with EPAct? , Washington, DC, December 21, 2012, p. 2. 
+
+56 House Committee on Energy and Commerce, Subcommittee on Energy, majority staff memorandum RE: Hearing 
+entitled “Legislation Addressing Pipeline and Hydropower Infrastructure Modernization,” May 1, 2017, p. 3, 
+http://docs.house.gov/meetings/IF/IF03/20170503/105916/HHRG-115-IF03-20170503-SD020.pdf. 
+
+57 See, for example, debate in the House Energy and Commerce Committee, Energy Subcommittee hearing on 
+Oversight of the Federal Energy Regulatory Commission and the FY2019 Budget, April 17, 2018. 
+
+58 U.S. Senator John Hoeven et al., April 29, 2021. 
+59 FERC, Office of Congressional Affairs, personal communication, May 30, 2018. 
+
+Congressional Research Service 
+
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+
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+ link to page 17 link to page 17 link to page 17 
+
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+deadline. Figure 3 shows the time from a developer’s filing of a pipeline certificate application to 
+its certification by the commission for new pipeline construction projects exceeding 20 miles in 
+length. As the figure shows, of the 60 pipeline projects included, 10 projects were approved more 
+than 24 months after filing. In addition, FERC’s docket records show one additional application 
+filed in 2019 and approved in 2020, as well as two pending applications (for 20+ mile pipelines) 
+filed in 2020.60 The figure does not include the time elapsed during pre-filing, which may vary for 
+different projects and also may take months. For example, the Mountain Valley Pipeline project 
+applied for FERC’s approval to pre-file approximately 12 months before filing a certificate 
+application.61 
+
+ Figure 3. Review Time for FERC Certificate, Pipelines over 20 Miles Long 
+
+Months After Filing 
+
+ 
+
+ Source: CRS analysis; FERC, “Approved Major Pipeline Projects (1997-Present),” data as of January 2021, 
+https://www.ferc.gov/industries-data/natural-gas/approved-major-pipeline-projects-1997-present. 
+ Notes: Figure includes only approved projects. Excludes pipeline projects under 20 miles in length, certificates 
+for natural gas compressor stations, requests for abandonment, and other approval orders. Applications are 
+shown in chronological order, but spacing does not correspond to specific dates of filing. 
+
+Whether FERC’s record of certificate application review demonstrates process efficiency is open 
+to debate because major pipeline projects are complex and unique. The review periods i n Figure 
+3 are highly varied and do not necessarily show any clear trend. Attempting to quantify or 
+evaluate FERC’s recent certificate review timing is complicated by the lack of a quorum of FERC 
+commissioners (required for certificate decisions) for six months in 2017. Furthermore, 
+application review time may also include time taken by developers responding to questions or 
+providing supplemental information or analysis requested by regulators, which may be outside 
+the control of the commission. 
+
+ 
+60 FERC, “Major Pipeline Projects Pending,” website, data as of March 2021, https://www.ferc.gov/industries-data/
+natural-gas/major-pipeline-projects-pending. 
+
+61 FERC, Order Issuing Certificates and Granting Abandonment Authority, Docket Nos. CP16-10-000 and CP-13-000, 
+161 FERC ¶ 61,043, October 13, 2017. 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+FERC also has faced challenges in its relations with state agencies exercising delegated federal 
+permitting authority, particularly for water quality permits under Section 401 of the Clean Water 
+Act. For example, FERC was involved in litigation for issuing a pipeline’s Section 401 water 
+quality permits—which were initially denied by a New York state agency—on the grounds of 
+excessive delay by the state.62 However, FERC declined to challenge New York’s denial of water 
+quality permits for a different pipeline project because the state made its decision within its one-
+year statutory deadline.63 Both projects had been granted FERC certificates but still needed the 
+state permits before beginning construction. 
+
+ Changes in the Natural Gas Industry Structure 
+ Over the last 20 years, there have been fundamental changes in the structure of the U.S. natural 
+gas sector. Most significant among these are widespread use of hydraulic fracturing, new gas 
+production regions (e.g., the Marcellus formation underlying parts of Pennsylvania and other 
+states), increasingly interconnected natural gas infrastructure in more populated areas, and greater 
+dependence on natural gas to fuel power plants. These changes, in turn, have introduced new 
+considerations in pipeline permit review, including new concerns about greenhouse gas 
+emissions, potential groundwater and seismic risks, pipeline safety, energy infrastructure security, 
+and changing contractual relationships with pipeline customers. For example, with the shift away 
+from coal to natural gas for power generation, regulators and operators have expressed new 
+concerns about the potential linkage between the availability of natural gas and the reliability of 
+electricity supply in markets with constrained infrastructure.64 Some stakeholders have asserted 
+that FERC should change or expand the nature of its certificate reviews to better account for these 
+new considerations.65 
+
+ Pipeline Infrastructure for Export 
+ The rapid growth in U.S. natural gas production has led to increased exports of pipeline gas to 
+Canada and Mexico and of liquefied natural gas to overseas buyers. Some communities affected 
+by pipeline development have questioned whether FERC appropriately applies the “public 
+convenience and necessity” standard under the Natural Gas Act to pipeline projects which would 
+serve export markets.66 FERC has asserted that considerations regarding the domestic versus 
+foreign destination of natural gas are solely under the jurisdiction of the Department of Energy, 
+which has statutory authority to approve the export of the natural gas commodity.67 Nonetheless, 
+some analysts have questioned whether FERC may evaluate pipelines proposed to facilitate 
+natural gas exports differently from those proposed to supply domestic markets.68 
+
+ 
+62 Colby Hamilton, “New York Loses Federal Appeal Over Millennium Gas Line Project,” New York Law Journal , 
+March 12, 2018. 
+
+63 FERC, Order on Petition for Declaratory Order, Docket No. CP18-5-000, 162 FERC ¶ 61,014, January 11, 2018. 
+64 North American Electric Reliability Corporation (NERC), Special Reliability Assessment: Potential Bulk Power 
+System Impacts Due to Severe Disruptions on the Natural Gas System , November 2017. 
+
+65 See, for example, Susan Tierney, “Natural Gas Pipeline Certification: Policy Considerations for a Changing 
+Industry,” Analysis Group, Inc., November 6, 2017, p. 15, http://www.analysisgroup.com/uploadedfiles/content/
+insights/publishing/ag_ferc_natural_gas_pipeline_certification.pdf. 
+
+66 John Dizard, “Trump’s Plan for Energy Dominance Meets Resistance,” Financial Times , February 24, 2018. 
+67 158 FERC ¶ 61,145, p. 10. 
+68 L.M. Sixel, “FERC May Rethink Pipeline Permits When LNG Is Headed Overseas,” Houston Chronicle , updated 
+February 19, 2018, https://www.chron.com/business/energy/article/FERC-may-rethink-pipeline-permits-when-LNG-is-
+
+Congressional Research Service 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
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+ 
+
+In litigation involving a pipeline project proposed partly for exports, a September 2019 court 
+decision remanded to FERC “for further explanation of why ... it is lawful to credit precedent 
+agreements with foreign shippers serving foreign customers toward a finding that an interstate 
+pipeline is required by the public convenience and necessity.”69 In its response to the court, the 
+Commission provided additional justification for using export precedent agreements as 
+appropriate evidence of market demand.70 However, some legal analysts continue to question 
+FERC’s certification of infrastructure developed partly or primarily to serve export markets.71 
+
+ Environmental Justice72 
+ Environmental justice, which involves concerns of disproportionate risks to health and safety 
+across communities with differing demographics (e.g., race, national origin, or income), has 
+become an important factor in natural gas pipeline siting.73 For example, the siting of a natural 
+gas compressor station for the proposed Atlantic Coast Pipeline in Union Hill, VA—a 
+predominately African-American community—became the subject of litigation on environmental 
+justice grounds.74 Since 1997, the President’s Council on Environmental Quality has provided 
+guidance for taking into account environmental justice in NEPA reviews.75 In 2020, FERC 
+officials reportedly stated that the commission “takes environmental justice concerns very 
+seriously,” and that the agency’s environmental reviews under properly analyze “socioeconomic 
+issues such as environmental justice.”76 Nonetheless, some on the commission and other 
+stakeholders have criticized FERC’s consideration of environmental justice issues in its pipeline 
+certification process.77 On February 11, 2021, the FERC chairman announced plans to create a 
+new senior-level staff position “charged with working with the experts in all FERC program 
+offices to integrate environmental justice and equity matters into Commission decisions.”78 
+
+ Public Participation 
+ Some in Congress have expressed concern about the ability of landowners and other members of 
+the public to understand and participate effectively in FERC’s pipeline certification process.79 
+
+ 
+12619700.php. 
+
+69 City of Oberlin v. FERC, 937 F. 3d (D.C. Cir. 2019) 
+70 172 FERC ¶ 61,199, pp. 7-13, 
+71 See, for example, Alexandra B. Klass, “The Public Use Clause in an Age of U.S. Natural Gas Exports,” Stanford 
+Law Review Online , April 15, 2020. 
+
+72 For further discussion, see CRS Legal Sidebar LSB10590, Addressing Environmental Justice Through NEPA , by 
+Nina M. Hart and Linda Tsang. 
+
+73 For further discussion of the concept of environmental justice, see CRS In Focus IF10529, Role of the U.S. 
+Environmental Protection Agency in Environmental Justice , by David M. Bearden and Angela C. Jones. 
+
+74 Friends of Buckingham v. State Air Pollution Control Board , 19-1152 (U.S. Court of Appeals, 4th Cir. 2020). 
+75 Council on Environmental Quality, Environmental Justice Guidance Under the National Environmental Policy Act , 
+December 10, 1997. This guidance was issued consistent with Executive Order 12898, “Federal Actions to Address 
+Environmental Justice in Minority Populations and Low-Income Populations,” 59 Federal Register 7629, February 16, 
+1994. 
+
+76 Arianna Skibell and Niina H. Farah, “FERC Faces Environmental Justice Reckoning,” E&E News , July 31, 2020. 
+77 See, for example, FERC, “Commissioner Richard Glick Dissent Regarding the Rio Grande LNG Terminal and Rio 
+Bravo Pipeline Projects,” press release, January 23, 2020. 
+78 FERC, “FERC Chairman Acts to Ensure Prominent FERC Role for Environmental Justice,” press release, February 
+11, 2021. 
+
+79 See, for example, U.S. Senator Jeanne Shaheen, “Shaheen Reintroduces Legislation to Boost Public Participation in 
+
+Congressional Research Service 
+
+ 
+
+15 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+Specific issues have included landowner notification, understanding of property rights, securing 
+intervenor status, and providing input and comments to FERC during project scoping and review 
+of permit applications, including NEPA review. In 1978, Congress amended the Federal Power 
+Act (Section 319) authorizing FERC to establish an Office of Public Participation to “coordinate 
+assistance to the public with respect to authorities exercised by the Commission,” and “also 
+coordinate assistance available to persons intervening or participating or proposing to intervene or 
+participate in proceedings before the Commission” (16 U.S.C. § 825q–1). However, funds were 
+not subsequently appropriated for this office and FERC did not establish it. In the past, FERC has 
+asserted that office was unnecessary, stating in a 2007 proceeding that “even if funding were 
+available, the public interest is adequately represented ... by the Commission, its staff and state 
+agencies,” but various public advocates and Members of Congress have disagreed with this 
+assertion.80 Likewise, the FERC chairman remarked in April 2021, “the people who can afford the 
+high-priced Washington, DC, law firms that participate in our proceedings, they’re adequately 
+represented, but a lot of other people aren’t—their voices aren’t heard.”81 
+
+In the joint House-Senate Appropriations Committee Report accompanying the Consolidated 
+Appropriations Act, 2021 (P.L. 116-260) Congress again addressed the Office of Public 
+Participation. The committee directed FERC to submit a report by June 25, 2021, detailing how 
+the commission will establish and operate the Office of Public Participation, including an 
+organizational structure and budget, beginning in FY2022 and funded through annual charges and 
+filing fees as authorized by the Federal Power Act and the Omnibus Budget Reconciliation Act of 
+1986.82 In accordance with this requirement, FERC announced it would convene a commissioner-
+led workshop “as part of an effort to establish the Office of Public Participation” on April 16, 
+2021.83 The details of FERC’s report, and how its plans may affect the commission’s review of 
+interstate natural gas pipeline certificate applications, remain to be seen. 
+
+ Recent Executive Orders 
+ The development of energy pipelines has been a focus of the last four presidents. The Bush, 
+Obama, Trump, and Biden Administrations issued a series of executive orders directed at the 
+federal permitting of infrastructure projects, specifically including energy infrastructure. A 
+number of these orders have been applicable to interstate natural gas pipelines under FERC’s 
+jurisdiction. Exactly how these orders have affected, or may affect, federal review of interstate 
+natural gas pipeline siting is not entirely clear, however, due to the complexity of the certification 
+process and permit obligations under related statutory requirements (e.g., NEPA). 
+
+ Executive Order 13212 
+ President George W. Bush issued E.O. 13212 on May 18, 2001. Focusing specifically on “energy-
+related projects,” the order directs federal agencies to “expedite their review of permits or take 
+ 
+Approval of Energy Projects and Rates,” press release, May 15, 2019. 
+80 121 FERC ¶ 61,184. 
+81 Richard Glick, FERC Chairman, online video, FERC offical facebook page, April 13, 2021, 
+https://www.facebook.com/watch/?v=264040458557354. 
+
+82 “Explanatory Statement Submitted by Mrs. Lowey, Chairwoman of the House Committee on Appropriations, 
+Regarding the House Amendment to the Senate Amendment to, Consolidated Appropriations Act, 2021,” 
+ Congressional Record , daily edition, vol. 166 (December 21, 2020), p. H8378. 
+
+83 FERC, “The Office of Public Participation; Notice of Workshop and Request for Panelists,” 86 Federal Register 
+11764, February 26, 2021. 
+
+Congressional Research Service 
+
+ 
+
+16 
+
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+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+other actions as necessary to accelerate the completion of such projects, while maintaining safety, 
+public health, and environmental protections.”84 In the context of natural gas pipelines, the 
+principal outcome of this order was the 2002 interagency agreement on early coordination of 
+pipeline certificate review, which remains in force. In 2005, FERC also signed a memorandum of 
+understanding with the Corps expanding upon this agreement “to further streamline respective 
+regulatory processes” consistent with the executive order.85 
+
+ Executive Order 13604 
+ President Obama issued E.O. 13604 on March 22, 2012, “to significantly reduce the aggregate 
+time required to make decisions in the permitting and review of infrastructure projects by the 
+Federal Government, while improving environmental and community outcomes.”86 Among other 
+requirements, the order called for federal agencies to select “infrastructure projects of national or 
+regional significance” to track on the online Federal Infrastructure Projects Dashboard (§2(c)). 
+
+In the context of this executive order, the Administration cited as a best practice for “pre-
+application/application improvements” FERC’s certificate pre-filing process, which was already 
+in place at the time.87 A May 17, 2013, Presidential Memorandum expanded upon the order, 
+directing the Steering Committee on Federal Infrastructure Permitting and Review Process 
+Improvement established by E.O. 13604 “to modernize Federal infrastructure review and 
+permitting regulations, policies, and procedures to significantly reduce the aggregate time 
+required by the Federal Government to make decisions in the review and permitting of 
+infrastructure projects,” including pipelines.88 However, it is not clear to what extent, if any, the 
+executive order and memorandum may have led to changes to aspects of FERC certification for 
+pipelines. None of the three pipelines from this period presumably identified as being “of national 
+or regional significance” (because they are listed on the federal permitting dashboard) were 
+natural gas pipelines.89 
+
+ Executive Order 13766 
+ Issued by President Trump on January 24, 2017, the order was intended “to streamline and 
+expedite, in a manner consistent with law, environmental reviews and approvals for all 
+infrastructure projects, especially projects that are a high priority for the Nation, such as ... 
+
+ 
+84 Executive Order 13212, “Actions to Expedite Energy-Related Projects,” May 18, 2001. 
+85 Department of the Army, “Memorandum of Understanding between the Army Corps of Engineers and the Federal 
+Energy Regulatory Commission for Interstate Natural Gas Pipeline Projects,” July 11, 2005, https://www.ferc.gov/
+legal/mou/mou-30.pdf. 
+
+86 Executive Order 13604, “Improving Performance of Federal Permitting and Review of Infrastructure Projects,” 
+March 22, 2012. In a memorandum released the same day, the President called on federal agencies to “coordinate and 
+expedite their reviews, consultations, and other processes as necessary to expedite decisions related to domestic 
+pipeline infrastructure projects,” but this directive was limited to a “domestic pipeline system for the transportation of 
+crude oil.” See The White House, “Presidential Memorandum—Expediting Review of Pipeline Projects from Cushing, 
+Oklahoma, to Port Arthur, Texas, and Other Domestic Pipeline Infrastructure Projects,” March 22, 2012. 
+
+87 The White House, Implementing Executive Order 13604 on Improving Performance of Federal Permitting and 
+Review of Infrastructure Projects , June 2012, p. 26. 
+
+88 The White House, “Modernizing Federal Infrastructure Review and Permitting Regulations, Policies, and 
+Procedures,” Presidential memorandum, May 17, 2013. 
+89 Federal Permitting Improvement Steering Council, “Permitting Dashboard,” online database, May 21, 2018, 
+https://www.permits.performance.gov/projects. The three listed projects were oil pipelines and are currently 
+categorized as “legacy” projects. 
+
+Congressional Research Service 
+
+ 
+
+17 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+pipelines.”90 Among other provisions, the order permitted governors, federal department and 
+agency heads, or the FERC chairman to request “high priority” status for a project with respect to 
+“expedited procedures and deadlines for completion of environmental reviews and approvals” 
+(§3). CRS has identified no interstate natural gas pipelines which were classified as high priority 
+under this order. 
+
+ Executive Order 13777 
+ Issued by President Trump on February 24, 2017, the order was intended “to lower regulatory 
+burdens on the American people by implementing and enforcing regulatory reform.”91 The order 
+required agencies to evaluate existing regulations and identify regulations for repeal, replacement, 
+or modification. Targeted regulations included those that, among other considerations, eliminated 
+jobs (or inhibited job creation); were outdated, unnecessary, or ineffective; or imposed costs that 
+exceeded benefits. In response to the order, FERC “established a regulatory reform task force to 
+perform a thorough review of the Commission’s regulations, policies, and processes, and to 
+identify opportunities to reduce regulatory burdens.”92 The commission also issued its April 19, 
+2018, NOI regarding its pipeline certification policies. 
+
+ Executive Order 13783 
+ Issued by President Trump on March 28, 2017, the order generally aimed to establish a policy to 
+promote domestic energy development and use, and ensure affordable and reliable electricity. To 
+accomplish these broad goals, the order directed executive agencies to review their existing 
+regulations and “appropriately suspend, revise, or rescind those that unduly burden” domestic 
+energy production or use, “with particular attention to oil, natural gas, coal, and nuclear energy 
+resources.” The order also rescinded guidance intended to help federal agencies determine how 
+and when to assess climate change effects and costs in rulemakings and environmental reviews. 
+As directed by the order, the CEQ withdrew its 2016 guidance, Consideration of Greenhouse Gas 
+Emissions and the Effects of Climate Change in National Environmental Policy Act Reviews . On 
+June 26, 2019, CEQ published draft NEPA guidance on consideration of greenhouse gas 
+emissions intended to replace the 2016 guidance.93 
+
+Being an independent agency, FERC was not subject to the executive order. Nonetheless, on 
+November 1, 2017, the commission voluntarily submitted a report reviewing FERC actions 
+pursuant to the order, which, among other things, encompassed the commission’s regulations, 
+guidance documents, and policies related to pipeline certification and environmental review under 
+NEPA.94 The report concluded that “the majority of agency actions relating to the siting and 
+construction of interstate natural gas transportation ... do not materially burden the transportation 
+
+ 
+90 Executive Order 13766, “Expediting Environmental Reviews and Approvals for High Priority Infrastructure 
+Projects,” January 24, 2017. 
+91 Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” February 24, 2017. 
+92 FERC, “Federal Energy Regulatory Commission One Federal Decision Implementation Plan,” July 9, 2018, p. 3. 
+93 Council on Environmental Quality, “Draft National Environmental Policy Act Guidance on Consideration of 
+Greenhouse Gas Emissions,” 84 Federal Register 30097-30099, June 26, 2019. 
+
+94 FERC, “Final Report: Review of Federal Energy Regulatory Commission Agency Actions Pursuant to Executive 
+Order 13783, Promoting Energy Independence and Economic Growth,” 82 Federal Register 50517-50523, November 
+1, 2017. 
+
+Congressional Research Service 
+
+ 
+
+18 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+or delivery of domestically produced natural gas,” and that there was “no need for the 
+Commission to consider any revision to this regulation.”95 
+
+ Executive Order 13807 
+ Issued by President Trump on August 15, 2017, the order was intended “to ensure that the Federal 
+environmental review and permitting process for infrastructure projects is coordinated, 
+predictable, and transparent.” The explicit goal of the order was to complete federal 
+environmental reviews and permitting decisions for major projects within two years of 
+application (§2(h)).96 A key component of E.O. 13807 was a “One Federal Decision” framework, 
+whereby each “major” infrastructure project had one lead federal agency responsible for the 
+overall permit process and issuing one Record of Decision, incorporating individual decisions 
+from cooperating or participating agencies (§5(b)). 
+
+On April 9, 2018, the FERC chairman signed a memorandum of understanding (MOU) with other 
+federal agencies to implement E.O. 13807.97 Under the MOU, the agencies agree to “undertake to 
+meet the goal set forth in E.O. 13807 of reducing the time to two years for each agency to 
+complete all environmental reviews and authorization decisions for major infrastructure projects” 
+through implementation of One Federal Decision, communication, concurrent reviews, adherence 
+to a review timetable, and commitment to agency-specific and collective review process 
+enhancements (§V). FERC already was the lead agency for pipeline certificate environmental 
+review and had statutory authority to set a review timetable under EPAct, so it appears the impact 
+of the MOU may have been primarily from cooperating agency coordination and setting the two-
+year goal. However, it is an open question how it has affected FERC’s ongoing review of pipeline 
+certificate applications. Nonetheless, FERC stated at the time that it was “committed to carrying 
+out the goals of Executive Order 13807 to improve the efficiency, timing, and overall 
+predictability of the certification process.”98 
+
+ Executive Order 13868 
+ Issued by President Trump on April 10, 2019, the order stated that “outdated federal guidance and 
+regulations regarding Section 401” of the Clean Water Act are “causing confusion and uncertainty 
+and are hindering the development of energy infrastructure.”99 Among other things, the order 
+directed the Environmental Protection Agency (EPA) to review and issue new guidance to 
+supersede the existing Section 401 guidance and to revise the agency’s existing Section 401 
+implementing regulations. The order instructed EPA to focus on the need to promote timely 
+federal-state cooperation, the appropriate scope of water quality reviews, the types of conditions 
+that may be appropriate to include in a certification, expectations for review times for different 
+types of certification requests, and the nature and scope of information states may need to act on a 
+certification request. EPA subsequently issued revised Section 401 guidance and, in July 2020, a 
+
+ 
+95 Ibid. p. 50521. 
+96 Executive Order 1387, “Establishing Discipline and Accountability in the Environmental Review and Permitting 
+Process for Infrastructure Projects,” August 15, 2017. 
+
+97 The White House, “Memorandum of Understanding Implementing One Federal Decision Under Executive Order 
+13807,” April 9, 2018, https://www.whitehouse.gov/wp-content/uploads/2018/04/MOU-One-Federal-Decision-m-18-
+13-Part-2.pdf. 
+
+98 Federal Energy Regulatory Commission (FERC), Certification of New Interstate Natural Gas Facilities , Notice of 
+Inquiry, Docket No. PL18-1-000, April 19, 2018, p. 22. 
+
+99 Executive Order 13868, “Promoting Energy Infrastructure and Economic Growth,” April 10, 2019. 
+
+Congressional Research Service 
+
+ 
+
+19 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+final water quality certification rule which replaced the prior implementing regulations.100 
+Although not directed at FERC, the EPA’s guidance and rulemaking was intended, in part, to 
+facilitate the state permitting of interstate natural gas pipelines also under FERC’s NGA 
+jurisdiction. 
+
+ Executive Orders 13990, 13992, and 14008 
+ Issued by President Biden on January 20, 2021, E.O. 13990 asserts a policy to, among other 
+things, “hold polluters accountable, including those who disproportionately harm communities of 
+color and low-income communities; to reduce greenhouse gas emissions; to bolster resilience to 
+the impacts of climate change; ... and to prioritize ... environmental justice.”101 The order directs 
+all executive departments and agencies to review and address the promulgation of regulations and 
+other actions during the last four years that conflict with these objectives, “and to immediately 
+commence work to confront the climate crisis.”102 This order also revokes Executive Orders 
+13766, 13783, 13807, and 13868. 
+
+On January 25, 2021, President Biden also issued E.O. 13992, which “revokes harmful policies 
+and directives that threaten to frustrate the Federal Government’s ability to confront ... problems” 
+including the COVID-19 pandemic, economic recovery, racial justice, and climate change.103 The 
+order revokes Executive Order 13777. 
+
+On January 27, 2021, President Biden issued E.O. 14008, which asserts an Administration policy 
+“to organize and deploy the full capacity of its agencies to combat the climate crisis to implement 
+a Government-wide approach that reduces climate pollution in every sector of the economy” and 
+“delivers environmental justice,” among other objectives.104 Although FERC, being an 
+independent agency, is not directly subject to these executive orders, the commission stated in 
+March 2021 that “there have been a series of recent administrative changes,” specifically E.O. 
+13990 and E.O. 14008, “and we continue to evaluate their impact on our review process.”105 
+
+ Legislative Proposals 
+ Over the last 20 years, Congress has acted frequently to oversee FERC’s certification of interstate 
+natural gas pipelines through hearings and correspondence with the commission.106 Members of 
+Congress also have proposed legislation to change FERC’s review of gas pipeline certificate 
+applications, either specifically or as one category among a broader range of infrastructure 
+projects. Proposals also have sought to change FERC’s regulations with respect to certificates it 
+has issued to pipeline developers. 
+
+ 
+100 Environmental Protection Agency. “Clean Water Act Section 401 Certification Rule,” 85 Federal Register 42210-
+42287, July 13, 2020 
+
+101 Executive Order 13990, “Protecting Public Health and the Environment and Restoring Science to Tackle the 
+Climate Crisis,” January 20, 2021. 
+
+102 Ibid. 
+103 Executive Order 13992, “Revocation of Certain Executive Orders Concerning Federal Regulation,” January 25, 
+2021. 
+
+104 Executive Order 14008, “Tackling the Climate Crisis at Home and Abroad,” January 27, 2021. 
+105 FERC, East Lateral XPress Project , Environmental Assessment, Docket No. CP20-527-000, March 2021, p. 72. 
+106 See, for example, U.S Representative Stephen F. Lynch, and U.S. Senators Elizabeth Warren and Edward Markey, 
+letter to the Honorable Richard Glick, Chairman, FERC, February 19, 2021, https://lynch.house.gov/index.cfm?a=
+Files.Serve&File_id=CDF3115A-C4E0-4B4C-9C4F-EC87566542ED. 
+
+Congressional Research Service 
+
+ 
+
+20 
+
+ 
+ link to page 25 Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Proposals in Prior Congresses 
+ In the 111th-116th Congresses, bills which were not enacted sought to increase FERC public 
+hearings, limit eminent domain authority, expand the scope of FERC’s environmental review, 
+require regional review of multiple projects, and impose specific deadlines on FERC and 
+cooperating agencies, among other measures. Title 41 of the Fixing America’s Surface 
+Transportation Act (P.L. 114-94; FAST-41), which became law on December 4, 2015, revised the 
+process for federal approval of a range of major infrastructure projects by establishing best 
+practices, requiring coordination of federal agency review of projects, and shortening the period 
+for challenges to final decisions for issuing project permits. Infrastructure projects covered by the 
+act are those requiring environmental review under NEPA and requiring investment exceeding 
+$200 million (§41001).107 As of April 2021, the permitting dashboard listed four natural gas 
+pipeline projects (two completed) covered under FAST-41 with FERC as the lead agency.108 A 
+summary table of the relevant legislative proposals in the 111th-116th Congresses is provided in 
+the Appendix . 
+
+ Legislative Proposals in the 117th Congress 
+ Some Members of Congress have introduced legislative proposals in the 117th Congress involving 
+FERC’s certification authority or review proces s. Table 1 summarizes the key provisions in these 
+bills related to natural gas pipeline certification. As the table shows, the proposals variously 
+would require FERC to collectively review multiple pipelines proposed in the same region, hold 
+more public meetings, restrict the use of eminent domain, and more broadly consider greenhouse 
+gas emissions. Some would require environmental monitoring of completed pipelines and 
+mandate greater cooperation and transparency of permit review by federal agencies. 
+
+ 
+
+ Table 1. Current Legislative Proposals Involving FERC Certification of Pipelines 
+
+(117th Congress) 
+
+ Bill Title 
+
+ Bill Number 
+
+ Key FERC Provisions 
+
+Landowner Fairness Act 
+
+S. 641 
+
+Would require FERC to consider certain factors in 
+pipeline permitting, would modify eminent domain 
+requirements, and would prohibit using NGA 
+eminent domain for a pipeline built for exports. 
+
+Ending Natural Gas Companies’ Seizure of 
+
+S. 655 
+
+Would prohibit the use of eminent domain by a 
+
+Land for Export Profits Act 
+
+FERC permit holder for a pipeline to be built 
+substantially for exports. 
+
+Environmental Justice Mapping and Data 
+
+H.R. 516 
+
+Would establish an interagency Environmental Justice 
+
+Col ection Act of 2021 
+
+Mapping Committee, including FERC, to create a tool 
+to identify environmental justice communities. 
+
+ 
+107 The Office of Management and Budget (OMB) and Council on Environmental Quality (CEQ) jointly issued 
+guidance for agencies to comply with FAST-41. See OMB and CEQ, “Guidance to Federal Agencies Regarding the 
+Environmental Review and Authorization Process for Infrastructure Projects,” memorandum, January 13, 2017. 
+
+108 Federal Permitting Improvement Steering Council, “Federal Infrastructure Permitting Dashboard,” online database, 
+April 30, 2021, accessible at https://www.permits.performance.gov/projects. 
+
+Congressional Research Service 
+
+ 
+
+21 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Bill Title 
+
+ Bill Number 
+
+ Key FERC Provisions 
+
+CLEAN Future Act 
+
+H.R. 1512 
+
+Would revise and fund FERC’s Office of Public 
+Participation to represent the interests of the public 
+in NGA-related proceedings. Would prohibit 
+pipeline companies from using NGA eminent domain 
+authority until they have all necessary federal and 
+state permits and comply with environmental permit 
+conditions. Would also prohibit using eminent 
+domain for natural gas pipelines to be built for 
+import or export. 
+
+Promoting Interagency Coordination for 
+
+H.R. 1616 
+
+Would expand FERC’s authority to act as the lead 
+
+Review of Natural Gas Pipelines Act 
+
+agency for coordinating all federal authorizations and 
+NEPA environmental reviews with respect to a 
+natural gas pipeline project. Also would require 
+consultation with the Transportation Security 
+Administration regarding pipeline security. 
+
+Safe and Accountable Federal Energy 
+
+H.R. 2115 
+
+Would require FERC to conduct an evidentiary 
+
+Review for Pipelines Act of 2021 
+
+hearing and/or cumulative review of major energy 
+infrastructure projects planned throughout a region. 
+Would require FERC to consider the existence of 
+other regional pipelines or underutilized pipeline 
+capacity in permit application reviews. Would 
+require FERC to monitor environmental impacts of 
+all approved and constructed projects for five years. 
+
+To amend the Natural Gas Act with 
+
+H.R. 2889 
+
+Would prevent pipeline companies from using NGA 
+
+respect to actions for eminent domain by 
+
+eminent domain authority until they have all 
+
+holders of certificates of public 
+
+necessary federal and state permits for construction 
+
+convenience and necessity, and for other 
+
+and operation. 
+
+purposes. 
+
+ Sources: http://www.congress.gov, CRS analysis. 
+ Notes: FERC= Federal Energy Regulatory Commission, NEPA = National Environmental Policy Act, NGA = 
+Natural Gas Act. 
+
+ FERC’s Policy Review 
+ As discussed earlier, FERC’s review of pipeline certificate applications is guided by its Policy 
+Statement on Certification of New Interstate Natural Gas Pipeline Facilities issued in 1999. On 
+December 21, 2017, the FERC chairman announced that the commission would undertake a 
+review of its permitting policies and procedures for interstate natural gas pipelines. Accordingly, 
+on April 19, 2018, the commission issued a Notice of Inquiry “to examine its policies in light of 
+changes in the natural gas industry and increased stakeholder interest in how it reviews natural 
+gas pipeline proposals.”109 More specifically, the commission’s notice posed “a range of questions 
+that reflected concerns raised in numerous public comments, court proceedings and other 
+forums,” and sought input on “potential changes to both the existing Policy Statement and the 
+structure and scope of the Commission’s environmental analysis” as well as “feedback on the 
+transparency, timing, and predictability of its certification process.”110 
+
+ 
+109 FERC, “Commission Initiates Notice of Inquiry into Pipeline Certificate Policy Statement,” press release, R-18-16, 
+April 19, 2018. 
+
+110 Ibid. 
+
+Congressional Research Service 
+
+ 
+
+22 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+According to its notice, FERC’s inquiry focused on four general aspects of its certificate 
+application review, with specific questions posed under each aspect 
+
+ relying on precedent agreements to demonstrate project need, 
+ eminent domain and landowner interests, 
+ evaluating project alternatives and environmental effects, and 
+ the efficiency and effectiveness of FERC’s certificate processes.111 
+
+FERC’s inquiry was opened for public comments through July 25, 2018.112 However, according 
+to the NOI, the commission intended to make no decisions on possible further action related to its 
+inquiry until it had reviewed the comments filed; the commission did not state any timetable for 
+completing this review.113 (FERC issued its 1999 policy statement over 13 months after 
+publishing a Notice of Inquiry for that proceeding.114) Through 2020, the commission took no 
+further action related to the NOI. 
+
+ Reopening the Policy Review 
+ On January 21, 2021 President Biden appointed a new FERC chairman (elevating a commissioner 
+who joined FERC in 2017).115 The appointment followed the November 30, 2020, Senate 
+confirmation of two new commissioners, restoring FERC to its full statutory complement of five 
+commissioners.116 On February 18, 2021, under its new chairman, FERC announced that it had 
+“reopened” its review of the 1999 policy statement and published a new NOI “asking for new 
+information and additional perspectives that would assist the Commission in moving forward 
+with its review ... looking to build upon the record already established.”117 In the announcement, 
+the FERC chairman stated “it’s important to recognize that many changes have occurred since our 
+initial inquiry three years ago.” At an industry event, the FERC chairman subsequently stated “we 
+have ... reinvigorated a proceeding that was begun many years ago,” noting that “our whole 
+process has come under some criticism—I’ve been critical of some aspects of it.”118 
+
+The 2021 NOI reaffirms the commission’s interest in the four general aspects of its certificate 
+application review covered in its 2018 NOI, some with modification. It also poses new questions 
+on an additional issue area examining FERC’s “identification and addressing of any 
+disproportionately high and adverse human health or environmental effects of its programs, 
+policies, and activities on environmental justice communities and the mitigation of those adverse 
+
+ 
+111 FERC 2018 NOI, pp. 45-46. 
+112 FERC, “Certification of New Interstate Natural Gas Facilities,” 83 Federal Register 24780, May 30, 2018. The 
+comment period was extended 30 days from an original closing date of June 25, 2018. 
+
+113 FERC 2018 NOI, p. 4. 
+114 FERC, “Regulation of Interstate Natural Gas Transportation Services,” Notice of Inquiry, 63 Federal Register 
+42974, 84 FERC ¶ 61,087, July 29, 1998. 
+
+115 FERC, “President Biden Names Glick Chairman of FERC,” press release, January 21, 2021. 
+116 FERC, “Senate Votes to Confirm Christie, Clements to Commission,” press release, November 30, 2020. 
+117 FERC, “FERC Revisits Review of Policy Statement on Interstate Natural Gas Pipeline Proposals,” press release, 
+February 18, 2021. 
+
+118 Richard Glick, FERC Chairman, remarks at the Women’s Council on Energy and the Environment, Virtual 
+Executive Series, April 29, 2021, video available at https://youtu.be/NT0jnNl6tpw. 
+
+Congressional Research Service 
+
+ 
+
+23 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+impacts and burdens.”119 The NOI solicits new information and stakeholder perspectives related 
+to the following five aspects of review, again, with specific questions posed under each aspect: 
+
+ potential adjustments to determination of need, 
+ eminent domain and landowner interests, 
+ consideration of environmental impacts, 
+ efficiency of the commission’s review process, and 
+ consideration of effects on environmental justice communities.120 
+
+The initial deadline for comments in the NOI was April 26, 2021, but it was subsequently 
+extended to May 26, 2021.121 The commission has established no deadline for taking further 
+actions with respect to the ROI, although the chairman has stated “I suspect we’ll be able to act 
+..., hopefully soon on this gas pipeline certificate proceeding.”122 Any FERC pipeline certification 
+activities or decisions in the meantime would be made in accordance with the 1999 policy 
+statement. Moreover, the FERC Chairman has stated that “the Commission will not wait to act on 
+Certificate applications while we consider options for improving the process.”123 Because 
+FERC’s policy statement is only a guidance document, not a regulation or statute, the commission 
+has considerable discretion regarding if, when, and how it will apply any policy changes to 
+pending certificate applications.124 
+
+ Policy Issues for Congress 
+ Congress has been interested in the development of natural gas pipelines for decades, with a 
+particular focus on siting and environmental impacts in recent years. Some in Congress generally 
+see such pipeline development as positive, primarily due to its perceived economic benefits in 
+terms of construction employment, lower natural gas prices, and environmental benefits relative 
+to burning more carbon-intensive fossil fuels (i.e., coal). Others generally view gas pipeline 
+development more critically, primarily due to environmental concerns from greenhouse gas 
+emissions. Still others are focused primarily on the local effects of gas pipeline development 
+related to public safety, the impacts on lands, the acquisition of private property through eminent 
+domain, and impacts on environmental justice communities. Pipeline proponents would rather see 
+more and faster pipeline development, whereas opponents would rather see less—preferring 
+instead a greater policy emphasis on energy alternatives, such as renewable electricity generation, 
+they view as more environmentally or socially benign. 
+
+Because FERC has the statutory authority to approve or deny certificates for interstate natural gas 
+pipelines, the policy views above have led to persistent congressional scrutiny of FERC’s pipeline 
+certification process and decisions. Concerns about gas pipelines have motivated repeated 
+attempts at congressional intervention. In total, over 40 bills have been introduced since the 111th 
+Congress (seven in the current Congress alone) which would affect various aspects of FERC’s 
+review of pipeline certificate applications. Of these, only the FAST Act (which seems to have 
+
+ 
+119 FERC 2021 NOI, p. 4. 
+120 FERC 2021 NOI. 
+121 FERC, “Notice Extending Time for Comments,” Docket No. PL18-1-000, March 31, 2021. 
+122 Richard Glick, April 29, 2021. 
+123 Richard Glick, May 21, 2021. 
+124 U.S. Court of Appeals for the District of Columbia, Consolidated Edison Company of New York, Inc., et al., v. 
+Federal Energy Regulatory Commission , No. 01-1345, January 17, 2003, https://www.cadc.uscourts.gov/internet/
+opinions.nsf/4B1331E528B23FC485256F82005F46BE/$file/01-1345a.txt. 
+
+Congressional Research Service 
+
+ 
+
+24 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+applied to only a few of FERC’s gas pipeline reviews) and the Consolidated Appropriations Act, 
+2021 became law. Therefore, absent any other statutory changes, Congress must rely on FERC to 
+address policy concerns on its own volition in response to congressional oversight, federal court 
+decisions, and public input. 
+
+FERC’s recent Notice of Inquiry covers a number of the key congressional concerns raised either 
+in oversight hearings or bill provisions in the 117th Congress. Examples include eminent domain 
+authority (H.R. 2115), environmental justice (H.R. 516), and determining market need (S. 1314). 
+Therefore, while FERC’s policy review does not guarantee any changes to the gas pipeline 
+certification status quo, it may provide valuable information and context for congressional 
+oversight. If Congress disagrees with FERC’s future policy choices based on the findings of its 
+NOI, those findings presumably would provide an informed basis and clear policy context for 
+subsequent legislative proposals. 
+
+Although recent executive and agency actions, including FERC’s agreements with other agencies 
+and its NOI, may lead to changes in FERC policies or process, they are limited to those aspects of 
+gas pipeline regulation which fall directly within the commission’s statutory authority under the 
+Natural Gas Act or within its discretion under other federal statutes. This is a significant 
+limitation because much of FERC’s pipeline certificate review is environmental review in 
+compliance with NEPA. While the bills identified in this report, and FERC’s policy review, could 
+change how FERC interprets or fulfills its obligations under NEPA, they would not amend NEPA 
+itself. Likewise, they would not amend other federal statutes, such as the Clean Water Act or the 
+Clean Air Act, which also may have a bearing on gas pipeline siting approval. 
+
+ 
+
+ 
+
+Congressional Research Service 
+
+ 
+
+25 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Appendix: Past FERC Permit Legislative Proposals 
+
+ Table 2.Past Legislative Proposals to Change FERC Certification of Pipelines 
+
+(111th through 116th Congresses) 
+
+ Bill 
+
+ Last Major 
+
+ Congress 
+
+ Bill Title 
+
+ Number 
+
+ Action 
+
+ Key FERC Provisions 
+
+111th 
+
+To require [FERC] to 
+
+S. 32 
+
+Referred to 
+
+Would have required FERC to hold a 
+
+hold at least one public 
+
+Subcommittee 
+
+public hearing in each county and locality 
+
+hearing before 
+
+affected by a pipeline proposal. Also would 
+
+issuance of a permit 
+
+H.R. 1922 Referred to 
+
+have required additional public hearings, if 
+
+affecting public or 
+
+Committee 
+
+requested, for issues not addressed in an 
+
+private land use in a 
+
+initial hearing. 
+
+locality 
+
+112th 
+
+Reaffirming 
+
+H.R. 3913 Referred to 
+
+Would have prohibited eminent domain 
+
+Constitutional 
+
+Subcommittee 
+
+for pipelines to be constructed for 
+
+Property Rights Act 
+
+transporting natural gas to an LNG 
+terminal for export. 
+
+113th 
+
+American Energy 
+
+H.R. 2 
+
+Passed in 
+
+Would have imposed on FERC a 12-month 
+
+Solutions for Lower 
+
+House 
+
+deadline to approve or deny pipeline 
+
+Costs and More 
+
+permit applications after pre-filing. Would 
+
+American Jobs Act 
+
+have required 90-day permit review for 
+pre-filed pipeline projects by other federal 
+
+113th 
+
+American Renaissance 
+
+H.R. 5360 Introduced 
+
+agencies involved; if a permit were not 
+
+in Manufacturing Act 
+
+approved or denied by this deadline, 
+approval would have taken effect. 
+
+114th 
+
+North American 
+
+S. 2012 
+
+House/Senate 
+
+Would have required FERC to identify and 
+
+Energy Security and 
+
+Conference 
+
+notify agencies participating in certificate 
+
+Infrastructure Act of 
+
+Held 
+
+review; federal permit decisions within 90 
+
+2016 
+
+days of FERC completing NEPA review; 
+and concurrent review by cooperating 
+agencies of non-NEPA actions. Would have 
+required greater transparency in review 
+scheduling, status, and reporting of delays. 
+
+114th 
+
+Fixing America’s 
+
+H.R. 22 
+
+Became P.L. 
+
+Title 41 requires greater agency 
+
+Surface Transportation 
+
+114-94 
+
+coordination and oversight of federal 
+
+(FAST) Act 
+
+review for infrastructure projects (e.g., 
+pipelines) subject to NEPA and requiring 
+investment over $200 mil ion. Establishes a 
+Federal Permitting Improvement Steering 
+Council—including FERC—to oversee, 
+facilitate, and recommend schedules and 
+best practices for federal permitting. 
+Requires greater transparency in review 
+scheduling, status, and reporting of delays. 
+
+114th 
+
+Natural Gas Pipeline 
+
+H.R. 161 
+
+Passed in 
+
+Would have imposed on FERC a 12-month 
+
+Permitting Reform Act 
+
+House 
+
+deadline to approve or deny pipeline 
+permit applications after pre-filing. Would 
+have required 90-day permit review for 
+pre-filed pipeline projects by other federal 
+agencies involved; if a permit were not 
+approved or denied by this deadline, 
+approval would have taken effect. 
+
+Congressional Research Service 
+
+ 
+
+26 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Bill 
+
+ Last Major 
+
+ Congress 
+
+ Bill Title 
+
+ Number 
+
+ Action 
+
+ Key FERC Provisions 
+
+114th 
+
+Safer Pipelines Act of 
+
+H.R. 5630 Referred to 
+
+If a proposed pipeline expansion were 
+
+2016 
+
+Committee 
+
+challenged, would have required a FERC 
+evidentiary hearing on the need for 
+expansion or a cumulative review of 
+energy projects planned in the region. For 
+new pipelines, would have required FERC 
+to consider under NEPA the cumulative 
+impacts of other pipeline projects in the 
+same state or within 100 miles. 
+
+115th 
+
+Timely Review of 
+
+S. 8 
+
+Referred to 
+
+Would have authorized FERC to raise staff 
+
+Infrastructure Act 
+
+Committee 
+
+pay so as to carry out its functions in a 
+timely, efficient, and effective manner. 
+
+115th 
+
+Timely Review of 
+
+H.R. 6552 Referred to 
+
+Infrastructure Act 
+
+Subcommittee 
+
+115th 
+
+Public Engagement at 
+
+S. 1240 
+
+Referred to 
+
+Would have revised and expanded FERC’s 
+
+FERC Act 
+
+Committee 
+
+Office of Public Participation to represent 
+the interests of the public in proceedings 
+
+115th 
+
+Public Engagement at 
+
+H.R. 2656 Referred to 
+
+on rates, service, and infrastructure siting. 
+
+FERC Act 
+
+Subommittee 
+
+115th 
+
+Pipeline Fairness and 
+
+S. 1314 
+
+Referred to 
+
+Would have required FERC to prepare a 
+
+Transparency Act 
+
+Subcommittee 
+
+supplemental EIS for an application if FERC 
+makes a substantial change or in case of 
+
+115th 
+
+Pipeline Fairness and 
+
+H.R. 2893 Referred to 
+
+new environmental circumstances or 
+
+Transparency Act 
+
+Committee 
+
+information. Also would have required 
+environmental impact mitigation plans; 
+public meetings in project counties; and 
+review of cumulative visual impacts on 
+national scenic trails. S. 1314 P.L. 99-3 H.R. 
+133 also would have required multiple 
+pipelines proposed within 100 miles of 
+each other to be evaluated as one project 
+under NEPA. 
+
+115th 
+
+Independent Agency 
+
+S. 1448 
+
+Referred to 
+
+Would have authorized the President to 
+
+Regulatory Analysis 
+
+Committee 
+
+require an independent regulatory agency 
+
+Act of 2017 
+
+to comply with analysis requirements 
+applicable to other federal agencies, and 
+
+115th 
+
+Promoting Interagency 
+
+H.R. 2910 Passed in 
+
+assess costs and benefits of economically 
+
+Coordination for 
+
+House 
+
+significant rules and alternatives. 
+
+Review of Natural Gas 
+Pipelines Act 
+
+115th 
+
+Energy and Natural 
+
+S. 1460 
+
+Committee 
+
+Would have required FERC to identify and 
+
+Resources Act of 2017 
+
+Hearings Held 
+
+notify agencies participating in review. 
+Would have required federal permit 
+decisions within 90 days of FERC 
+completing NEPA and concurrent review 
+by cooperating agencies of non-NEPA 
+actions. Would have required greater 
+transparency in review scheduling, status, 
+and reporting of delays. 
+
+Congressional Research Service 
+
+ 
+
+27 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Bill 
+
+ Last Major 
+
+ Congress 
+
+ Bill Title 
+
+ Number 
+
+ Action 
+
+ Key FERC Provisions 
+
+115th 
+
+Rebuild America Now 
+
+S. 1756 
+
+Committee 
+
+Would have imposed on FERC a one-year 
+
+Act 
+
+Hearings Held 
+
+deadline to approve or deny pipeline 
+permit applications after pre-filing. Would 
+have required 90-day permit review for 
+pre-filed pipeline projects by other federal 
+agencies involved; if a permit were not 
+approved or denied by this deadline, 
+approval would take effect. Would have 
+allowed aerial survey data to satisfy 
+pipeline permit preliminary requirements. 
+
+115th 
+
+Safer Pipelines Act of 
+
+H.R. 2649 Referred to 
+
+If a proposed pipeline expansion were 
+
+2017 
+
+Subcommittee 
+
+challenged, would have required FERC to 
+assign the application to an administrative 
+law judge to conduct an evidentiary hearing 
+on the need for the expansion and report 
+the findings. Would have required FERC to 
+cumulatively review major energy projects 
+planned in the region. For new interstate 
+pipelines, would have required FERC to 
+consider under NEPA the cumulative 
+impacts of other projects in the same state 
+or within 100 miles. 
+
+115th 
+
+To require [FERC] to 
+
+H.R. 3241 Referred to 
+
+Would have required FERC environmental 
+
+consider greenhouse 
+
+Committee 
+
+reviews under NEPA to consider 
+
+gas emissions related 
+
+greenhouse gas emissions from pipeline 
+
+to natural gas 
+
+construction and operation, and the 
+
+pipelines, and for 
+
+production, transportation, and 
+
+other purposes 
+
+combustion of the natural gas to be 
+transported through the pipeline. 
+
+115th 
+
+Natural Gas Pipeline 
+
+H.R. 4381 Referred to 
+
+Would have suspended construction of 
+
+Public Health 
+
+Committee 
+
+FERC-certificated natural gas facilities until 
+
+Protection Act of 2017 
+
+remediation of air quality violations. 
+
+115th 
+
+No title 
+
+H. Amdt. 
+
+Not agreed to 
+
+Would have excluded from provisions in 
+
+204 to 
+
+H.R. 2910 pipelines on lands managed for 
+
+H.R. 2910 
+
+conservation or recreation. 
+
+115th 
+
+No title 
+
+H. Amdt. 
+
+Not agreed to 
+
+Would have required FERC to supplement 
+
+206 to 
+
+an environmental impact statement under 
+
+H.R. 2910 
+
+NEPA for a pipeline project if there is a 
+substantial change in the proposed action 
+or significant new circumstances or 
+information. 
+
+116th 
+
+Timely Review of 
+
+S. 607 
+
+Reported by 
+
+Would have authorized FERC to raise staff 
+
+Infrastructure Act 
+
+Committee 
+
+pay so as to carry out its functions in a 
+timely, efficient, and effective manner. 
+
+116th 
+
+Independent Agency 
+
+S. 869 
+
+Referred to 
+
+Would have authorized the President to 
+
+Regulatory Analysis 
+
+Committee 
+
+require an independent regulatory agency 
+
+Act 
+
+to comply with analysis requirements 
+applicable to other federal agencies, and 
+
+assess costs and benefits of economically 
+significant rules and alternatives. 
+
+116th 
+
+Public Engagement at 
+
+S. 1477 
+
+Referred to 
+
+Would have revised and expanded FERC’s 
+
+FERC Act 
+
+Committee 
+
+Office of Public Participation to represent 
+
+Congressional Research Service 
+
+ 
+
+28 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+ Bill 
+
+ Last Major 
+
+ Congress 
+
+ Bill Title 
+
+ Number 
+
+ Action 
+
+ Key FERC Provisions 
+
+116th 
+
+Public Engagement at 
+
+H.R. 3240 Referred to 
+
+the interests of the public in proceedings 
+
+FERC Act 
+
+Subcommittee 
+
+on rates, service, and infrastructure siting. 
+
+116th 
+
+Federal Permitting 
+
+S. 1976 
+
+Referred to 
+
+Would have required FERC to report to 
+
+Reform and Jobs Act 
+
+Committee 
+
+Congress recommendations on ways to 
+reconcile FERC permitting regulations with 
+
+116th 
+
+Federal Permitting 
+
+H.R. 3671 Reported by 
+
+requirements under the FAST Act. 
+
+Reform and Jobs Act 
+
+Subcommittee 
+
+116th 
+
+Pipeline Fairness, 
+
+S. 4502 
+
+Referred to 
+
+Would have amended the NGA to address 
+
+Transparency, and 
+
+Committee 
+
+landowner notice, eminent domain, and 
+
+Responsible 
+
+environmental review for interstate natural 
+
+Development Act of 
+
+gas pipelines, as well as their impacts on 
+
+2020 
+
+national scenic trails. Also would have set a 
+45-day deadline on FERC permit rehearing 
+decisions. 
+
+116th 
+
+Reaffirming Property 
+
+S. 4673 
+
+Referred to 
+
+Would have required FERC to consider 
+
+Rights Through 
+
+Committee 
+
+certain factors in issuing pipeline permits 
+
+Natural Gas Act 
+
+and would modify eminent domain 
+
+Modernization Act 
+
+requirements pipeline construction. 
+
+116th 
+
+Consolidated 
+
+H.R. 133 
+
+Became P.L. 
+
+Committee report directs FERC to submit 
+
+Appropriations Act, 
+
+116-260 
+
+a report detailing how it wil establish and 
+
+2021 
+
+operate the Office of Public Participation, 
+including an organizational structure and 
+budget, beginning in FY2022. 
+
+116th 
+
+Pipeline Fairness and 
+
+H.R. 173 
+
+Referred to 
+
+Would have amended the NGA to address 
+
+Transparency Act 
+
+Subcommittee 
+
+eminent domain and environmental review 
+for interstate natural gas pipelines, as well 
+as their impacts on national scenic trails. 
+
+116th 
+
+Reaffirming 
+
+H.R. 2198 Referred to 
+
+Would have prohibited the use of eminent 
+
+Constitutional 
+
+Subcommittee 
+
+domain by a FERC permit holder for a 
+
+Property Rights Act 
+
+pipeline supplying an LNG export facility. 
+
+116th 
+
+Promoting Interagency 
+
+H.R. 3983 Referred to 
+
+Would have required that federal, state, 
+
+Coordination for 
+
+Committee 
+
+and local agencies involved in 
+
+Review of Natural Gas 
+
+environmental review defer to FERC’s 
+
+Pipelines Act 
+
+approved scope for NEPA review. Would 
+have required FERC permit decisions 
+
+116th 
+
+Promoting Interagency 
+
+H.R. 7401 Referred to 
+
+within 90 days of completing NEPA review. 
+
+Coordination for 
+
+Subcommittee 
+
+Would require concurrent review by 
+
+Review of Natural Gas 
+
+cooperating agencies. H.R. 3983 also would 
+
+Pipelines Act 
+
+have required consultation with the 
+Transportation Security Administration 
+regarding pipeline security 
+
+116th 
+
+To require [FERC] to 
+
+H.R. 4657 Referred to 
+
+Would have required FERC environmental 
+
+consider greenhouse 
+
+Subcommittee 
+
+reviews under NEPA to consider 
+
+gas emissions related 
+
+greenhouse gas emissions from pipeline 
+
+to natural gas 
+
+construction and operation, and the 
+
+pipelines, and for 
+
+production, transportation, and 
+
+other purposes 
+
+combustion of the natural gas to be 
+transported through the pipeline. 
+
+Congressional Research Service 
+
+ 
+
+29 
+
+ 
+ Interstate Natural Gas Pipeline Siting: FERC Policy and Issues for Congress 
+
+ 
+
+116th 
+
+Fairness for 
+
+H.R. 5454 Referred to 
+
+Would have prohibited or suspended the 
+
+Landowners Facing 
+
+Subcommittee 
+
+use of eminent domain under a FERC 
+
+Eminent Domain Act 
+
+pipeline permit under certain 
+circumstances. Would have prohibited the 
+use of eminent domain attached to any 
+facility that imports or exports natural gas. 
+
+116th 
+
+Scenic Trail Viewshed 
+
+H.R. 7878 Referred to 
+
+Would have allowed FERC to permit 
+
+Protection Act 
+
+Committee 
+
+pipelines crossing or impacting the view 
+from a national scenic trail only under 
+certain conditions. 
+
+ Sources: http://www.congress.gov, CRS analysis. 
+ Notes: FERC= Federal Energy Regulatory Commission, LNG= liquefied natural gas, NEPA = National 
+Environmental Policy Act, NGA = Natural Gas Act. 
+
+ 
+
+ Author Information 
+ 
+Paul W. Parfomak 
+
+ 
+
+Specialist in Energy and Infrastructure Policy 
+ 
+
+ 
+
+ Acknowledgments 
+
+Lynn J. Cunningham, Senior Research Librarian, helped prepare the legislative tables in this report. 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan 
+shared staff to congressional committees and Members of Congress. It operates solely at the behest of and 
+under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other 
+than public understanding of information that has been provided by CRS to Members of Congress in 
+connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not 
+subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in 
+its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or 
+material from a third party, you may need to obtain the permission of the copyright holder if you wish to 
+copy or otherwise use copyrighted material. 
+
+ 
+
+Congressional Research Service 
+
+R45239 · VERSION 7 · UPDATED 
+
+30
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+Order Code RL30215
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ The Magnuson-Stevens Fishery 
+
+ Conservation and Management Act: 
+
+ Reauthorization Issues 
+
+ Updated September 8, 2004 
+
+Eugene H. Buck
+
+Specialist in Natural Resources Policy
+
+Resources, Science, and Industry Division
+
+Daniel A. Waldeck
+
+Presidential Management Intern
+
+Resources, Science, and Industry Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ The Magnuson-Stevens Fishery Conservation 
+
+and Management Act: Reauthorization Issues
+
+ Summary 
+
+Fishery policy, guided by the Magnuson-Stevens Fishery Conservation and
+
+Management Act (MSFCMA), originally focused on mandates to identify fisheries,
+encourage underdeveloped fisheries, and establish databases for socioeconomic
+variables. Since that time, new issues have emerged, including a recognition of the
+need to identify, measure, and respond to overfishing and to incorporate an ecological
+perspective in fishery management through increased attention to habitat. The
+MSFCMA was last reauthorized and extensively amended in 1996. Although the
+authorization of appropriations under the MSFCMA expired at the end of FY1999,
+the Act’s requirements continue in force. At issue for Congress are the terms and
+conditions of any provisions designed to reauthorize and amend the Act to address
+the concerns of various interest groups.
+
+To identify potential reauthorization issues, CRS queried commercial harvesters,
+
+recreational fishermen, fishery managers, fishery scientists, fish processors, fishery
+unions, and environmental organizations to identify matters that they would like to
+see discussed during a reauthorization debate. Identified issues include (1) whether
+to further specify the approaches to address bycatch and bycatch mortality; (2) how
+to define, manage, and protect unique habitats; (3) whether to legislate the
+designation of marine protected areas; (4) how to assure that necessary data are
+collected; (5) how to manage marine ecosystems; (6) how to assure that regional
+council decisions are fair and balanced; (7) how to implement and finance fishing
+capacity reduction programs; (8) whether to establish national standards for
+individual fishing quota management programs; and (9) whether to authorize user
+fees and other charges that could be used for conservation, management, and
+enforcement. Other prominent issues may include how to define fishing community ,
+whether to revise the fishery management plan review process, and how best to
+manage highly migratory species. Because of the major changes that have occurred
+in marine fisheries since the MSFCMA originated in the mid-1970s, some suggest
+that the underlying management structure of U.S. fisheries should be reviewed to
+reassess whether fisheries should be managed at the regional or national level. In
+addition, both the Pew Oceans Commission and the U.S. Commission on Ocean
+Policy have recommended major changes in U.S. fishery management policy.
+
+Potential participants in the reauthorization debate anticipate extended
+
+negotiations on some of these issues and on concerns that have arisen as the 1996
+MSFCMA amendments in the Sustainable Fisheries Act have been implemented. In
+the House, the Committee on Resources has jurisdiction over any MSFCMA
+reauthorization legislation. In the Senate, the Committee on Commerce, Science, and
+Transportation has jurisdiction on this issue. Oversight field hearings have been held
+and MSFCMA reauthorization bills have been introduced. Most of the issues
+discussed in this report are not time-sensitive, and early attention to many of these
+issues is not anticipated. This report will be updated as this issue evolves.
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Constituencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Recreational Fishing Interests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+Commercial Fishing Sector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Environmental Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Native Americans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Fishery Scientists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Fishery Managers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Fish and Seafood Consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+The Magnuson-Stevens Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+
+Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+The Sustainable Fisheries Act . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+Subsequent Enactments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+Oceans Commissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+
+Issues for Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+
+Biological Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
+
+Bycatch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
+Essential Fish Habitat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
+Marine Protected Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+Overfishing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+Harmful Non-Native Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+
+Management Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+
+Data Collection and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+Ecosystem vs. Single-Species Management . . . . . . . . . . . . . . . . . . . . 24
+Decision-Making by Regional Councils . . . . . . . . . . . . . . . . . . . . . . . 27
+Highly Migratory Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
+Review of Fishery Management Plans . . . . . . . . . . . . . . . . . . . . . . . . . 31
+Management Based on Maximum Sustainable Yield . . . . . . . . . . . . . 32
+Coordination and Oversight of State-Managed Fisheries . . . . . . . . . . 33
+Decentralized Fishery Management . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
+Co-Management and the Role of Native Americans . . . . . . . . . . . . . . 34
+Aquaculture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
+Review of American Fisheries Act Provisions . . . . . . . . . . . . . . . . . . 35
+National Research Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
+Observer Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
+Experimental Fishing Permits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
+
+Socioeconomic Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
+
+Fishing Capacity Reduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
+Individual Fishing Quotas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
+Fees, Cost Recovery, and Economic Rent . . . . . . . . . . . . . . . . . . . . . . 41
+Fishery Subsidies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
+Fishing Communities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
+Small Boat Fleets and Family Fishermen . . . . . . . . . . . . . . . . . . . . . . 46
+
+ 
+ Transfer Pricing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
+The Definition of Recreational Fishing . . . . . . . . . . . . . . . . . . . . . . . . 47
+The Private Cost of Resource Management . . . . . . . . . . . . . . . . . . . . . 47
+Federal Assistance to Fishermen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
+Fishing Vessel and Crew Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
+
+Adequacy of Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
+
+Congressional Outlook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
+
+Appendix: Oceans Commissions’ Recommendations . . . . . . . . . . . . . . . . . . . . . 49
+
+ 
+ The Magnuson-Stevens Fishery
+
+Conservation and Management Act:
+
+Reauthorization Issues
+
+ Introduction 
+
+The Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA)
+
+(P.L. 94-265, as amended; 16 U.S.C. §§1801, et seq.) provides authority for federal
+fishery management in the waters of the U.S. Exclusive Economic Zone.1 It was
+reauthorized and extensively amended in the 1996 Sustainable Fisheries Act (P.L.
+104-297). Although the MSFCMA’s authorization for appropriations expired at the
+end of FY1999, the Act’s requirements remain in force and funding has continued,
+even without reauthorization. At issue for Congress are the terms and conditions of
+any provisions designed to reauthorize and amend the Act to address the concerns of
+various interest groups. Congress will be asked to review the direction and criteria
+provided by the MSFCMA for allocating fish and shellfish harvest among domestic
+interests in an era of mounting private and public demands for these resources.
+
+To identify the breadth of issues that might be brought before Congress during
+
+the ongoing reauthorization debate, CRS asked commercial harvesters, recreational
+fishermen, fishery managers, fishery scientists, fish processors, fishery unions, and
+environmental groups about their concerns and expectations for the debate. This
+report discusses the concerns of a broad cross-section of federal marine fishery
+management and conservation interests, to facilitate understanding the differing
+positions and to outline options for addressing policy concerns.2
+
+Congress has been active in and supportive of fishery conservation and
+
+management issues for many years, responding primarily to concerns of
+environmental interests, Native Americans, and commercial and recreational fishing
+groups. Congress generally seems to view the MSFCMA as working well, while
+possibly needing certain changes to address concerns that have arisen since the 1996
+amendments were enacted. In the House, the Committee on Resources has
+jurisdiction over MSFCMA reauthorization legislation. In the Senate, the Committee
+
+1 The MSFCMA defines this zone as contiguous to the territorial sea of the United States
+and extending seaward 200 nautical miles measured from the baseline from which the
+territorial sea is measured. Generally, the federal government, through the National Marine
+Fisheries Service/NOAA Fisheries, has jurisdiction in waters from the outer boundary of
+state waters out to 200 nautical miles offshore.
+
+2 Respondents were guaranteed anonymity to facilitate a candid discussion of issues.
+Presentation of constituent opinion in this report represents a sampling, not a quantitative
+assessment.
+
+ 
+ CRS-2
+
+on Commerce, Science, and Transportation has jurisdiction over legislation on this
+issue. Since the enactment of the Sustainable Fisheries Act in 1996, these
+committees have held numerous oversight hearings to review MSFCMA
+implementation and issues. Reauthorization bills were introduced in the 106th and
+107th Congresses, and one was reported in the House during the 107th Congress, but
+no further action was taken. Action on reauthorization legislation introduced in the
+108th Congress is discussed in CRS Issue Brief IB10109, Fishery, Aquaculture, and
+Marine Mammal Legislation in the 108th Congress , by Eugene H. Buck.
+
+ Constituencies 
+
+An array of groups and individuals hold common and conflicting interests in our
+
+nation’s fisheries. Despite their diversity, they generally share the goals of ensuring
+sustainable fisheries and maintaining healthy ecosystems. These groups, however,
+often disagree about how best to achieve these goals and use our common resources,
+and conflicts arise. The following descriptions are general characterizations. There
+is enormous variability and crossover of membership among these groups, which
+often blurs the distinction among the concerns within each group. For example,
+fishery scientists may act as objective independent analysts or serve as advocates for
+a specific sector, with the same scientist performing multiple roles on different
+issues. As Congress considers reauthorization of the MSFCMA, these diverse groups
+will advocate a wide variety of policies.
+
+ Recreational Fishing Interests. 3 In 2002, more than 10.5 million anglers
+
+fished in marine recreational fisheries, accounting for 73 million fishing trips.4 The
+marine finfish catch was estimated to be 421 million fish, of which more than 55%
+were reported to have been released alive.5 The estimated weight of the total harvest
+was 228 million pounds.6 The overall economic impact of marine recreational
+fishing in 1996 was $25.1 billion.7 In 2001, marine angler expenditures totaled $8.4
+billion.8 Components of the recreational sector include extractive (e.g., individual
+fishermen) and non-extractive users (e.g., divers who do not spear, gather, or
+
+3 Many marine recreational fisheries occur entirely within state waters. Therefore,
+depending on the fishery, federal management under the MSFCMA may not be an issue.
+
+4 U.S. Dept. of Commerce, National Marine Fisheries Service, Fisheries of the United
+States, 2002 . Current Fishery Statistics No. 2002 (Sept. 2003), p. 26 (hereafter “NMFS
+Fishery Statistics”). A different estimate (9.1 million anglers accounting for nearly 72
+million fishing trips) is provided by U.S. Dept. of the Interior, Fish and Wildlife Service and
+U.S. Dept. of Commerce, Bureau of Census, 2001 National Survey of Fishing, Hunting, and
+Wildlife-Associated Recreation (Oct. 2002), p. 6 (hereafter “FWS Fishing Survey”).
+
+5 NMFS Fishery Statistics, p. 26. The National Marine Fisheries Service (now NOAA
+Fisheries) does not provide an estimate of mortality after release. Several respondents note
+that, in some instances, mortality after release may be quite high.
+
+6 NMFS Fishery Statistics, p. 26.
+
+7 U.S. Dept. of Commerce, National Marine Fisheries Service, Accomplishment Report
+under the Recreational Fishery Resources Conservation Plan (1997). See [http://www.
+nmfs.noaa.gov/irf/recaccmp97.html], visited Aug. 11, 2004.
+
+8 FWS Fishing Survey, p. 8.
+
+ 
+ CRS-3
+
+otherwise harvest marine life) as well as charter and other commercial operations
+catering to sport anglers.
+
+A principal objective of this group is to receive equal consideration (relative to
+
+the commercial fishing sector) in decisions affecting access to and participation in
+U.S. fisheries. They are concerned that the substantial economic benefits to the
+nation of recreational fishing are not adequately recognized. Moreover, for fish
+conservation and habitat protection, recreational interests would like federal
+managers to distinguish between the impacts of recreational fishing and those of
+commercial fish harvesting. The balance between commercial and recreational
+interests varies widely among issues, species, and regions, with many regulations that
+restrict the activities of commercial fishermen, such as closed areas and quota
+restrictions, having little parallel for the recreational sector.
+
+ Commercial Fishing Sector. In 2001, there were more than 64,000
+
+commercial fishing boats and vessels operating in U.S. marine fisheries,9 and 3,410
+processing and wholesale plants, employing 71,533 individuals.10 In 2002, the total
+catch of marine fish in the 50 states was 9.4 billion pounds, with an estimated ex-
+vessel value11 of $3.1 billion.12 For 2002, the overall economic contribution of
+commercial fishing to gross national product (in value added) was estimated to be
+$28.4 billion.13
+
+This sector is chiefly concerned with ensuring sustainable fisheries that balance
+
+environmental protection with the continued viability and sustainability of their
+industry and communities. This sector includes a diverse group of interests, each
+with specific concerns regarding the rational use of living marine resources and the
+equitable allocation of resources among user groups. These sectors divide according
+to scale of operation; type of activity (fishermen, catcher-processor, processor); type
+of fishing gear used (trawl, longline, gillnet, pots, seine); and location (inshore or
+offshore), with most of these subdivisions represented by an association that seeks
+to communicate constituent values and influence policy.
+
+ Environmental Groups. More than 50 national and many more regional and
+
+local U.S. environmental organizations focus primarily or largely on marine fishery
+issues or some aspect thereof. Membership in these groups ranges into the millions,
+including many recreational and commercial fishermen. Relative to the MSFCMA,
+environmental groups are principally concerned with overfishing of certain fish
+
+9 NMFS Fishery Statistics, p. 94. This number is a significant underestimate since estimates
+are not available for nine coastal states.
+
+10 NMFS Fishery Statistics, p. 95. This number represents individuals employed by
+processors and wholesale plants, an indeterminate portion of which are employed on floating
+processors at sea. It does not include catching, transporting, or retail marketing of
+commercially-caught fish, nor does it include jobs supported by commercial fisheries.
+
+11 Ex-vessel value is the money paid to the harvester for fish, shellfish, and other aquatic
+plants and animals (i.e., the dollar value of the harvest when it is off-loaded from the vessel).
+
+12 NMFS Fishery Statistics, p. iv.
+
+13 NMFS Fishery Statistics, p. v.
+
+ 
+ CRS-4
+
+stocks, the lack of assessment data for many managed stocks, the direct and indirect
+harm to other marine species (including marine mammals, sea turtles, and sea birds),
+the failure of current methods to report bycatch14 accurately, the protection of marine
+biodiversity, and the continuing loss of habitat. They frequently maintain that there
+has been a nationwide failure to protect habitat from fishing and non-fishing harm.
+
+ Native Americans. Because of their cultural, traditional, and subsistence15
+
+needs, many tribes and indigenous groups are deeply concerned about the
+management of marine fisheries. Some tribes and indigenous groups are guaranteed
+access to certain fishery resources by treaty, with the federal government obliged to
+protect and maintain these rights.16 Some tribes and groups are represented by
+Fishery Commissions that coordinate fishery management with federal agencies. The
+long-term goals of tribes and indigenous groups generally include safeguarding
+cultural traditions, promoting economic stability, encouraging resource sustainability,
+and attaining regulatory certainty. Of particular concern during MSFCMA
+reauthorization will be cooperative management of marine fisheries (i.e., partnership
+with the federal government in establishing policy and determining management
+goals), which they believe fosters economic vitality, environmental health, and
+rational management of natural resources.
+
+ Fishery Scientists. Scientists from academia, the private sector, and state
+
+and federal agencies are principally involved in analyzing the ecological/biological,
+social, cultural, and economic effects of MSFCMA provisions and fishery
+management policy. Like the other groups, they are concerned with the health and
+integrity of marine ecosystems, the rational use of marine resources, and community
+sustainability. Specifically, they are interested in the availability of adequate funding
+and accurate data to perform the necessary analyses. Many fishery scientists, at some
+point in their careers, may be employed as fishery managers, since sound
+management is promoted by scientific understanding of the resource.
+
+ Fishery Managers. Federal and state fishery managers are charged with
+
+implementing the MSFCMA and complementary state programs. Because of this
+responsibility, their interests and concerns are more keenly focused on the pragmatic
+aspects of the MSFCMA. Specifically, they are interested in clarity in the intent of
+management requirements and in authorizations and requirements for data collection
+and research.
+
+ Fish and Seafood Consumers. Individuals and families seek to maintain
+
+access to a wide range of fish and seafood products in the marketplace in response
+
+14 Bycatch is the incidental catch of non-targeted fish species, which are typically discarded
+(often dead) because they are either illegal to retain or of an undesirable species, size, or sex.
+
+15 Critics contend that subsistence is a non-issue, because no groups or communities in the
+United States are starving or are likely to starve as a result of fishery harvest restrictions.
+Others, however, point out that a subsistence lifestyle refers to traditional and customary use
+and encompasses more than nutritional concerns.
+
+16 For an example of how Native American treaty fishing rights have been interpreted by the
+courts, see the summary provided by the Center for Columbia River History at [http://
+www.ccrh.org/comm/river/legal/boldt.htm], visited on July 16, 2004.
+
+ 
+ CRS-5
+
+to perceptions that these products are tasty, nutritious, and healthy sources of protein.
+The stability, sustainability, safety, and diversity of supply, including international
+trade relationships, are important issues for these consumers.
+
+ The Magnuson-Stevens Act 
+
+ Background 
+
+On September 28, 1945, President Truman issued a proclamation aimed at
+
+implementing conservation measures outside and adjacent to American territorial
+waters.17 The 1945 Truman Proclamation, claiming U.S. jurisdiction over U.S.
+continental shelf resources adjacent to the U.S. coast, has been viewed as the advent
+of coastal nations extending territorial seas and declaring fishery and economic
+zones.18 President Truman did not declare an “exclusive economic zone” nor claim
+rights to exclusive fishing, but his unilateral proclamations (on the seabed, its subsoil,
+and certain “conservation zones”) served as the conceptual underpinnings of
+subsequent extensions.19
+
+In the late 1940s and early 1950s, several Latin American nations proclaimed
+
+marine jurisdictions extending 200 miles off their Pacific coasts. This action was
+denounced by those within the United States20 and other distant-water fishing nations
+who sought to preserve and expand access for far-ranging fishing vessels.
+
+Beginning in the 1950s (Atlantic) and 1960s (Pacific), increasing numbers of
+
+foreign fishing vessels steamed into waters offshore of the United States to catch the
+substantially unexploited living marine resources.21 Since the United States then
+claimed only a 3-mile jurisdiction (a 12-mile U.S. contiguous fishery zone was
+proclaimed in 1966), foreign vessels could fish many of the same stocks caught by
+U.S. fishermen. U.S. fishermen deplored this “foreign encroachment” and alleged
+that overfishing was causing stress on, or outright depletion of, fish stocks. Complex
+and inconclusive Law of the Sea Treaty negotiations in the 1970s provided impetus
+for unilateral U.S. action on ocean management jurisdiction.
+
+17 Proclamation No. 2667, Policy of the United States with Respect to the Natural Resources
+of the Subsoil and Sea Bed of the Continental Shelf , 3 C.F.R. §67 (1943-1948).
+
+18 CRS Issue Brief IB95010, The Law of the Sea Convention and U.S. Policy: Issue Brief ,
+by Marjorie A. Browne.
+
+19 Jamison E. Colburn. “Turbot Wars: Straddling Stocks, Regime Theory, and a New U.N.
+Agreement,” Florida State University Journal of Transnational Law & Policy , vol. 6, no.
+2 (1997), note 73.
+
+20 Particularly commercial fishing interests seeking tuna.
+
+21 For example, the increase of foreign fishing off Alaska is discussed in Eugene H. Buck,
+ National Patterns and Trends of Fishery Development in the North Pacific (Anchorage, AK:
+Arctic Environmental Information and Data Center, Univ. of Alaska, 1973), 65 pp.
+
+ 
+ CRS-6
+
+The enactment of the Fishery Conservation and Management Act (FCMA) in
+
+1976 (renamed in 198022 to honor the late Senator Warren G. Magnuson, and in
+199623 to include Senator Ted Stevens) ushered in a new era of federal marine fishery
+management. After several years of debate, the FCMA was signed into law on April
+13, 1976, as P.L. 94-265. Under the FCMA, on March 1, 1977, marine fishery
+resources beyond state jurisdiction but within 200 miles of all U.S. coasts came under
+federal jurisdiction. A new regional management system began allocating fishing
+privileges, with priority given to domestic enterprise. Primary federal management
+authority was vested in the National Marine Fisheries Service (NMFS, now NOAA
+Fisheries) within the National Oceanic and Atmospheric Administration (NOAA) of
+the Department of Commerce. The FCMA’s 200-mile fishery conservation zone was
+superseded by an Exclusive Economic Zone (EEZ) proclaimed by President Reagan
+on March 10, 1983.24
+
+The FCMA created eight regional fishery management councils and their
+
+associated advisory committees. Based on provisions in the FCMA and guidelines
+provided by NMFS/NOAA Fisheries, the regional councils prepare fishery
+management plans (FMPs) for those fisheries that they determine require active
+federal management.25 After public hearings, revised FMPs and draft implementing
+regulations are submitted to the Secretary of Commerce for approval. Approved
+plans are implemented through regulations published in the Federal Register .
+Together these regional councils have implemented 40 FMPs for various fish and
+shellfish resources, with 9 additional plans in various stages of development.26 Some
+plans are created for single species or for several closely related species (e.g., FMPs
+for red drum by the South Atlantic Regional Council and for shrimp by the Gulf of
+Mexico Regional Council). Others are developed for multi-species assemblages
+inhabiting a similar habitat (e.g., FMPs for Gulf of Alaska groundfish by the North
+Pacific Regional Council and for reef fish by the Gulf of Mexico Regional Council).
+Many of the implemented plans have undergone subsequent amendment (one more
+than 30 times), and three plans have been developed and implemented jointly by two
+regional councils.
+
+Initially, a substantial portion of fishery resources in federal offshore waters was
+
+allocated for foreign fishing. However, foreign allocations diminished as domestic
+fishing and processing industries expanded. Under the FCMA, foreign catch from
+the U.S. EEZ declined from about 3.8 billion pounds in 1977 to zero since 1992.
+Triggering this decline of foreign catch, domestic offshore catch increased
+
+22 P.L. 96-561 §238.
+
+23 P.L. 104-208 §208.
+
+24 Proclamation No. 5030, Exclusive Economic Zone of the United States of America , 3
+C.F.R. Comp. (1983), p. 22. Although this proclamation implemented one of the Law of the
+Sea (LOS) provisions, the United States has not yet ratified the LOS Convention.
+
+25 Pursuant to the 1996 revisions of the MSFCMA, FMPs for Atlantic highly migratory
+species are prepared by the Secretary of Commerce (NMFS/NOAA Fisheries) with
+consultation by the relevant regional councils, advisors to international agreements, and
+advisory panels. See MSFCMA, §304(g).
+
+26 See [http://www.nmfs.noaa.gov/sfa/domes_fish/FMPS.htm], visited July 16, 2004.
+
+ 
+ CRS-7
+
+dramatically, from about 1.6 billion pounds (1977) to more than 5.9 billion pounds
+(2002). Thus, the share of fish caught by foreign nations from the U.S. EEZ declined
+from 71% in 1977 to zero in 1992; foreign fishing has not been permitted in the U.S.
+EEZ since 1992. For combined inshore and offshore domestic harvest in 2002, the
+marine recreational finfish catch was 0.2 billion pounds, while the commercial sector
+landed 9.4 billion pounds of finfish and shellfish.
+
+ The Sustainable Fisheries Act 
+
+In 1996, Congress approved and President Clinton signed the Sustainable
+
+Fisheries Act (SFA; P.L. 104-297),27 amending the MSFCMA with new requirements
+to (1) conserve fish stocks and restore overfished populations, (2) assure that
+membership on regional councils is fair and balanced, (3) impose a moratorium on
+creating new individual fishing quota programs, (4) increase emphasis on social
+benefits that might better preserve traditional small-scale fishermen, and (5)
+strengthen provisions to minimize bycatch and restore and protect habitat.
+
+The SFA established requirements that each FMP include a definition of
+
+overfishing, a plan for rebuilding overfished stocks (including stopping overfishing
+within two years and developing a plan to rebuild overfished fisheries within 10
+years), conservation and management measures to minimize bycatch, and a
+description of essential fish habitat (EFH) for the species involved (including
+conservation and management measures to protect habitat).
+
+Bycatch is the incidental catch of non-targeted fish species. These species are
+
+typically discarded (often dead) either because they are illegal to retain or because
+they are of an undesirable species, size, or sex. Such discards trigger concerns about
+environmental harm and economic waste. The SFA mandated that FMPs include
+standardized reporting to assess the amount and type of bycatch in managed fisheries.
+The SFA also mandates conservation measures to minimize bycatch and the mortality
+of unavoidable bycatch to the extent practicable.
+
+Based on concerns that certain fish stocks had declined due to habitat loss,28 the
+
+SFA established a national program to facilitate long-term protection of EFH.29 The
+SFA requires regional councils to identify and describe EFH for each managed
+fishery; identify and assess the harm and potential harm caused by fishing and
+non-fishing activities; minimize as much as possible the harm caused by fishing,
+which may include gear restrictions or time/area closures; identify harm to habitat of
+proposed fishing and non-fishing activities requiring federal or state approval or
+permits; and assist NMFS/NOAA Fisheries in recommending measures to conserve,
+enhance, and restore EFH.
+
+27 For a summary of the evolution and passage of this law, see archived CRS Issue Brief
+IB95036, Magnuson Fishery Conservation and Management Act Reauthorization , by
+Eugene H. Buck.
+
+28 See MSFCMA §2(a)(2)(C); 16 U.S.C. §1801(2)(a)(2)(C).
+
+29 See MSFCMA §305(b); 16 U.S.C. §1855(b).
+
+ 
+ CRS-8
+
+NMFS/NOAA Fisheries and the eight regional councils were responsible for
+
+implementing the provisions and requirements mandated in the SFA. Regional
+councils were given two years (until October 11, 1998) to revise or write FMPs to
+meet all the new requirements. To comply with SFA requirements, NMFS/NOAA
+Fisheries drafted a strategy detailing the necessary implementation tasks.30 Through
+this process, NMFS/NOAA Fisheries and the regional councils have addressed most
+of the SFA requirements. The NMFS/NOAA Fisheries Implementation Activity List
+ indicates what has been accomplished.31
+
+ Implementation. The provisions and requirements of the SFA reflect
+
+significant changes to the goals and objectives of the MSFCMA, and full
+implementation of these provisions has been of great concern to many groups.
+Accordingly, there has been considerable interest in the actions of regional councils
+and NMFS/NOAA Fisheries in implementing the SFA.
+
+Of particular concern to environmental groups and some Members of Congress
+
+is the progress of NMFS/NOAA Fisheries and regional councils in implementing
+SFA requirements. In their review of proposed FMP amendments, some of the more
+critical interests suggest that regional councils have instituted only incremental
+changes to current management practices. These critics contend that regional
+councils have satisfied only the minimum requirements and, in some cases, failed to
+comply with the law, rather than fully embracing the new goals and objectives.
+Moreover, they suggest that NMFS/NOAA Fisheries precipitated the poor
+performance of regional councils by delaying implementation guidance and by
+allowing substantial latitude in how regional councils implement the SFA provisions.
+
+Some commercial fishermen contend that the standards established by
+
+NMFS/NOAA Fisheries guidelines are unrealistic, given the dearth of scientific
+information. They contend that this has resulted in assumption-based and model-
+based goals that are at odds with implementing meaningful protection. Moreover,
+some commercial fishing interests contend that, given the magnitude of tasks set
+before regional councils and NMFS/NOAA Fisheries, the timetables established by
+the SFA were unrealistic and hence delays were inevitable.
+
+NMFS/NOAA Fisheries has not formally commented on the criticisms. They
+
+indicate that their efforts have focused on accomplishing the myriad tasks set forth
+in the SFA and implementing the law, rather than on addressing the concerns of
+citizens who disagreed with their strategy or progress.
+
+ Subsequent Enactments 
+
+The MSFCMA has been amended and modified a number of times to address
+
+specific concerns since the last comprehensive reauthorization in 1996. On October
+23, 1998, President Clinton signed into law modified language from S. 1221 (the
+
+30 U.S. Dept. of Commerce, National Marine Fisheries Service, Sustainable Fisheries Act
+Implementation Plan (1996). Many NMFS/NOAA Fisheries SFA implementation
+documents are available at [http://www.nmfs.noaa.gov/sfa/], visited Aug. 11, 2004.
+
+31 Available at [http://www.nmfs.noaa.gov/sfa/activity/index.html], visited Aug. 11, 2004.
+
+ 
+ CRS-9
+
+American Fisheries Act, or AFA) as part of the Omnibus Consolidated and
+Emergency Supplemental Appropriations for Fiscal Year 1999 (Title II of P.L. 105-
+277, 112 Stat. 2681-616). These provisions (1) require owners of all U.S.-flag
+fishing vessels to retain at least a 75% U.S.-controlling interest; (2) identify eligible
+participants for the Bering Sea and Aleutian Islands walleye pollock fishery;
+(3) include a vessel buy-back program for nine catcher/processor vessels financed by
+federal and private sector funds; (4) establish pollock allocations for three separate
+industry sectors; and (5) establish protocols for fishermen’s and fish processor’s
+cooperatives in the Bering Sea and Aleutian Islands walleye pollock fishery. The
+AFA prohibits any new fishing vessel exceeding 165 feet in length, or 750 tons, or
+with engines that produce greater than 3,000 horsepower from entering any
+MSFCMA managed fishery, unless the Secretary of Commerce and the relevant
+regional council approve the use of the vessel.32
+
+In the 106th Congress, P.L. 106-31 included language in §3025 making
+
+permanent a one-year moratorium (included in P.L. 105-277) on operating large
+fishing vessels in the North Atlantic herring and mackerel fisheries until regional
+action is taken. In addition, Title VI of P.L. 106-450 authorized the Secretary of
+Commerce to acquire and equip fishery survey vessels, and P.L. 106-557 prohibited
+shark finning in U.S. waters.
+
+In the 107th Congress, §10107 of P.L. 107-171 (the Farm Security and Rural
+
+Investment Act of 2002) appropriated “such sums as are necessary” to support a
+voluntary fishing capacity reduction program for the New England multispecies
+commercial fishery, within one year of enactment. P.L. 107-206 included
+(1) language to make Fisheries Finance Program Account funds available to
+subsidize gross obligations for the principal amount of direct loans not to exceed $5
+million for individual fishing quota loans, and not to exceed $19 million for
+traditional loans; (2) $11 million in economic assistance to New England fishermen
+and fishing communities (§210); (3) $5 million of direct economic assistance to New
+England fishermen and communities to support port security (§211); and (4) a $0.5
+million loan guarantee for a $50 million capacity reduction program for the West
+Coast groundfish fishery (§212). Section 624(a) of P.L. 107-77 extended state
+authority to manage the West Coast Dungeness crab fishery through FY2006. In
+addition, several enactments amended the AFA to address specific concerns:
+
+! Section 2202 of P.L. 107-20 altered provisions relating to the
+
+applicability of U.S. ownership standards to banks holding
+commercial fishing vessel mortgages;
+
+! Section 211 of P.L. 107-77 deleted a sunset provision, effectively
+
+making permanent a prohibition on direct pollock fishing by non-
+AFA catcher/processors; and 
+
+! Section 205 of P.L. 107-117 made the entire $100 million for the
+
+AFA’s fishing capacity reduction program available as a loan under
+Title XI of the Merchant Marine Act, 1936.
+
+32 Except for vessels fishing in the U.S. EEZ under the authority of the Western Pacific
+Regional Council or purse seine vessels engaged in tuna fishing in the Pacific Ocean outside
+of the U.S. EEZ; see §202(a)(5) of P.L. 105-277.
+
+ 
+ CRS-10
+
+Action taken by the 108th Congress is discussed and summarized in CRS Issue
+
+Brief IB10109, Fishery, Aquaculture, and Marine Mammal Legislation in the 108th
+Congress , by Eugene H. Buck.
+
+ Oceans Commissions 
+
+Two ocean commissions recently released reports relating to marine fisheries.
+
+The Pew Oceans Commission report33 was released June 4, 2003, and the U.S.
+Commission on Ocean Policy’s preliminary report34 was issued on April 20, 2004.
+Fishery issues are only one aspect of the comprehensive ocean policy issues
+discussed in these reports; the larger context includes governance, education, coastal
+development, human health, environmental quality, energy resources, and ocean
+science, among others. For background on the reports and the larger context of these
+issues, see CRS Issue Brief IB10132, Ocean Commissions: Ocean Policy Review and
+Outlook . A table in the Appendix to this report compares the reports’
+recommendations relating to marine fisheries. As is normally the case, CRS takes
+no position with respect to either report’s recommendations.
+
+ Issues for Congress 
+
+The remainder of this report discusses issues that may be considered during any
+
+reauthorization debate on the MSFCMA. However, few fishery issues are national
+in scope, and regional concerns vary greatly; what may be a major concern in one
+region may be inconsequential or entirely different in character in another.35 Thus,
+many of these issues are likely to be debated in a regional, rather than national,
+context. Some of the more controversial issues that may be addressed during
+reauthorization include (1) whether to further specify the approaches to address
+bycatch and bycatch mortality; (2) how to define, manage, and protect unique
+habitats; (3) whether to legislate the designation of marine protected areas; (4) how
+to assure that necessary data are collected; (5) how to manage marine ecosystems; (6)
+how to assure that regional council decisions are fair and balanced; (7) how to
+implement and finance fishing capacity reduction programs; (8) whether to establish
+national standards for individual fishing quota management programs; and (9)
+whether to authorize user fees and other charges that could be used for conservation,
+management, and enforcement. Many of these issues were addressed in 1996.
+Additional issues have been prompted by the recommendations from the Pew Oceans
+
+33 The Pew Oceans Commission, America’s Living Oceans: Charting a Course for Sea
+Change , available at [http://www.pewoceans.org/oceans/index.asp] on Apr. 27, 2004.
+
+34 U.S. Commission on Ocean Policy, Preliminary Report of the U.S. Commission on Ocean
+Policy , available at [http://oceancommission.gov/documents/prelimreport/welcome.html]
+on Apr. 27, 2004.
+
+35 An example can be seen with the bycatch issue, where concerns for sea turtle survival
+(although turtles are not bycatch, as defined in the MSFCMA) and, more recently, finfish
+bycatch reduction in shrimp trawls make this issue much more controversial in the Gulf of
+Mexico and South Atlantic regions.
+
+ 
+ CRS-11
+
+Commission and the U.S. Commission on Ocean Policy (see “Oceans Commissions,”
+above.)
+
+Another matter of likely debate is the current management structure of regional
+
+councils and agency regulation and how they affect fisheries management. The issue
+before Congress is whether fisheries management could be improved through
+increased legislative control over regional council decision-making or by providing
+regional councils greater autonomy over their management activities. Those in favor
+of increased legislative control argue that it could quiet criticisms that fishery
+managers misinterpret the intent of Congress and decrease perceived conflict of
+interest in regional council decision-making. Conversely, local communities would
+likely be concerned that national management would lose sight of local issues.
+Others contend that increased congressional involvement in managing fisheries could
+lead to increased politicization and further increase the time it takes to respond to
+problems and concerns.
+
+Other prominent issues may include whether and how to increase fishery
+
+management data collection efforts, how to define fishing community , whether to
+revise the FMP review process, how best to manage highly migratory species, and
+whether to increase emphasis on preserving ecosystem health and long-term resource
+productivity. These issues have arisen repeatedly, and the MSFCMA often has been
+amended in attempts to address them.
+
+To increase the usefulness and readability of this report, the issues and concerns
+
+that follow are grouped according to similarity in subject matter, although aspects of
+many issues transcend this artificial grouping. The order in which this information
+is presented does not represent a ranking or hierarchy of importance.
+
+ Biological Issues 
+
+Various constituencies have voiced concern regarding the need to clarify and/or
+
+modify how the fishery resource is viewed under the MSFCMA. These concerns
+range from narrow suggestions for improving aspects to reflect increasing
+understanding in fishery science to broad commentary on what actions are necessary
+to achieve the overall MSFCMA goal of sustainable resource productivity.
+
+ Bycatch. Bycatch is fish harvested in a fishery, but not sold or kept for
+
+personal use, and includes economic discards and regulatory discards.36 Economic
+discards are fish that are targeted by the fishery, but are not retained because they are
+of an undesirable size, sex, or quality, or for other economic reasons.37 Regulatory
+discards are fish harvested in a fishery that fishermen are required by regulation to
+discard whenever caught, or to retain but not sell.38 The MSFCMA’s definition of
+bycatch explicitly excludes fish released alive under a recreational catch-and-release
+fishery management program. Section 2(c)(3) of the MSFCMA encourages
+
+36 16 U.S.C. §1802(2).
+
+37 16 U.S.C. §1802(9).
+
+38 16 U.S.C. §1802(33).
+
+ 
+ CRS-12
+
+development of measures to minimize bycatch to the extent practicable and avoid the
+unnecessary waste of fish. Section 301(9) establishes a national standard that
+requires conservation and management measures to minimize bycatch and bycatch
+mortality.
+
+Environmental groups assert that many regional councils’ draft FMPs generally
+
+do not meet the SFA requirements related to bycatch.39 They charge that, at best,
+regional councils have concentrated their efforts on developing strategies and
+procedural measures, rather than taking direct action to minimize bycatch and
+bycatch mortality. Environmental interests also contend that many regional councils
+(e.g., New England, Mid-Atlantic, Gulf of Mexico, and Caribbean Regional
+Councils) neglected to submit FMP amendments that addressed SFA bycatch
+requirements.
+
+Some environmental groups contend that most regional councils have failed to
+
+assess the adequacy of current bycatch reporting methods and identify what is
+necessary to establish standardized bycatch reporting methods. Specific
+recommendations include accurately quantifying bycatch of target species (fish
+discarded because they are not marketable) and non-target species (fish caught
+incidentally), accounting for catch and bycatch before catch is sorted, and expanding
+the use of NMFS/NOAA Fisheries observers to measure total catch.
+
+Some fishery managers suggest that the MSFCMA’s definition of bycatch may
+
+need to be reviewed, as it is important to the practical implementation of bycatch
+controls in the MSFCMA. These managers assert that, while these definitions may
+seem clear, in practice they are quite problematic. Bycatch, in essence, pertains to
+fish that are discarded.40 Thus, one direct way for regional councils to reduce
+discards would be to require retention and utilization of all catch. However, these
+managers and environmental groups suggest that this does not address the incidental
+catch of non-targeted species. Moreover, these individuals suggest that the definition
+of economic discards is of little practical use, contending that it might better be
+described as “any discard that is not a regulatory discard.” They also note that in
+many fisheries it is difficult to accurately determine the amount of regulatory
+discards. For example, NMFS/NOAA Fisheries fishery observers in North Pacific
+groundfish fisheries collect data on total catch weights and estimate the percent of
+catch retained (the difference being an estimate of the amount discarded). The
+accuracy and reliability of these estimates are often questioned. As a means to better
+estimate total fishing mortality, the SFA mandated standardized reporting to assess
+bycatch. Many fishery managers assert, however, that collecting accurate data may
+pose a substantial financial burden and may be infeasible.
+
+As an alternative, these managers suggest that the MSFCMA definition of
+
+bycatch should be amended to include retained and discarded incidental catch of fish
+and non-fish species (e.g., sea birds), and that the terms economic and regulatory 
+
+39 The Marine Fish Conservation Network and The Center for Marine Conservation, Missing
+the Boat (Washington, DC: 1999), p. 2.
+
+40 Bycatch, by its MSFCMA definition, does not include incidentally caught sea turtles, sea
+birds, and other non-fish organisms.
+
+ 
+ CRS-13
+
+discards should be eliminated. Additionally, congressional consideration of how best
+to discourage bycatch might also include initiating and monitoring full retention of
+catch, with requirements for donating prohibited species to charitable organizations.
+
+Similarly, some commercial fishing interests contend that the concept of
+
+regulatory discards needs to be addressed, to better encourage the commercial sector
+to support fishery management strategies. They assert that the principle that “fish are
+better discarded dead than brought to market” undermines any possibility of industry
+support for management actions. They point to the summer flounder fishery, where
+as much as half of the total allowable catch quota has been discarded because of
+minimum fish size limits and quota/trip limits.
+
+Despite the legislative and regulatory efforts of Congress, NMFS/NOAA
+
+Fisheries, and the regional councils to address bycatch and waste, these issues are
+still of great concern to the public, environmental organizations, recreational anglers,
+and commercial fishermen. During reauthorization, these groups may suggest that
+Congress consider:
+
+! creating additional incentives for commercial and recreational
+
+fishermen to avoid bycatch or reduce bycatch mortality of
+incidentally caught species (e.g., individual or vessel bycatch
+allowances);41
+
+! directing NMFS/NOAA Fisheries to implement increasingly
+
+stringent regulations that close fisheries or penalize individuals for
+high levels of bycatch and bycatch mortality, and to increase funding
+for enforcement;
+
+! funding research for innovative fishing gear that reduces bycatch
+
+and/or bycatch mortality;
+
+! creating tax incentives for using bycatch reduction devices;
+! allowing nonprofit utilization of fish that would otherwise be
+
+discarded; and
+
+! increasing funding for NMFS/NOAA Fisheries to research and
+
+develop bycatch reduction measures.
+
+Some additional options to create incentives for avoiding bycatch might be to:
+
+! increase funding to place more NMFS/NOAA Fisheries observers on
+
+board vessels to obtain reliable bycatch data;
+
+! strengthen the definition of bycatch to directly address the problems
+
+of non-selective fishing practices, and correct the misinterpretation
+
+41 Concerns about vessel bycatch allowances (VBAs) include the following: (1) some
+fishermen contend that VBAs are both efficient (they provide the proper incentives for
+reducing bycatch) and equitable (they reward individuals who avoid bycatch or reduce
+bycatch mortality); (2) conversely, some environmental groups and other fishermen assert
+that VBAs provide no guarantee that bycatch will be reduced below what is currently
+allowed because the allocated bycatch effectively becomes a right to continue taking
+bycatch; and (3) some scientists point out that individual observer data can be highly
+variable, with a potentially disparate effect on fishermen with VBAs who may be saddled
+with incompetent, lazy, or dishonest observers.
+
+ 
+ CRS-14
+
+that equates dead discards of non-target fish with voluntary release
+of target fish; and
+
+! require that all sources of mortality, including dead discards, be
+
+counted against total allowable catch quotas.
+
+Some fishery scientists suggest that the use of new fishing gear could greatly
+
+reduce bycatch and bycatch mortality. Currently, the use of new gear is regulated by
+the List of Fisheries and Gear (50 C.F.R. §600.725(v)) and Notification Guidelines
+ (50 C.F.R. §600.747(H)).42 The Notification Guidelines establish a process for
+notifying regional councils (or NMFS/NOAA Fisheries, in the case of Atlantic HMS)
+of the intent to use new gear43 and guidelines for approving new gear.44 Some fishery
+scientists are concerned that this process is burdensome and discourages the
+development and use of new fishing gear. They may suggest that Congress review
+the process by which regional councils authorize the use of new fishing gear, and
+consider ways to encourage the development and use of innovative fishing
+technologies.45 Specific to the development of innovative fishing gear, these
+scientists may suggest that Congress require regional councils to discuss several
+additional concerns in FMPs, including:
+
+! requirements for developing and implementing bycatch reduction
+
+plans;
+
+! specific funding to study gear that reduces bycatch;
+! harvest access incentives for fishermen participating in the
+
+development of bycatch reduction devices; and
+
+! technical assistance programs to help design and conduct statistically
+
+valid studies for assessing the effectiveness of bycatch reduction
+devices.
+
+ Essential Fish Habitat. Section 305(b) of the MSFCMA establishes
+
+requirements for identifying, describing, conserving, and enhancing EFH. Section
+303(a)(7) requires FMPs to minimize the harm to EFH caused by fishing. Section
+303(a)(8) establishes requirements for scientific data needed to implement FMPs.
+Section 3(10) defines EFH. Regulations provide some guidelines as to how EFH is
+
+42 64 Federal Register 4030, Jan. 27, 1999.
+
+43 No person or vessel may use fishing gear or participate in a fishery (commercial and
+recreational) not included in the list without giving 90 days advance notice to the
+appropriate regional council or the Secretary (64 Federal Register 4031, Jan. 27, 1999).
+
+44 If a regional council finds that the new gear or fishery would not compromise the
+effectiveness of conservation and management efforts under the Magnuson-Stevens Act, the
+regional council will recommend to the regional administrator that the authorized list of
+fisheries be amended (64 Federal Register 4031, Jan. 27, 1999).
+
+45 Experimental fisheries are regulated under 50 C.F.R. §679.6, which allows regional
+administrators to authorize experimental fisheries for groundfish in a manner that would be
+otherwise prohibited. Some note that NMFS’s/NOAA Fisheries’ centralized control of
+scientific, experimental, and exempted permits has resulted in long delays in processing
+applications. They recommend making permits available on a regional basis.
+
+ 
+ CRS-15
+
+to be identified in FMPs,46 including provisions for designating habitat areas of
+particular concern (HAPC) that may be especially important to the long-term
+productivity of populations of one or more managed species.47
+
+Fishery scientists, environmental groups, and commercial and recreational
+
+fishing interests are concerned about how NMFS/NOAA Fisheries, the regional
+councils, and others have interpreted these EFH provisions. Additionally, the paucity
+of tangible scientific data has been widely viewed as a hindrance to identifying,
+describing, and conserving EFH. Environmental groups commend the regional
+councils for their success in identifying and describing EFH. However, these groups
+suggest that, while there have been some strides in addressing the harm caused by
+fishing and non-fishing activities, most regional councils have yet to establish
+measures to reduce the harmful effects of fishing activities on habitat. Some
+environmental groups view this lack of action as a major shortcoming of EFH
+implementation, and suggest that congressional action might be required to force
+regional councils to act.
+
+The MSFCMA defines EFH as “those waters and substrate necessary to fish for
+
+spawning, breeding, feeding or growth to maturity.” There is considerable debate
+about how to distinguish between essential and non-essential habitat.48 The aquatic
+environment has few clearly defined boundaries. Thus, habitat necessary to support
+fisheries is not easily recognizable or quantifiable. For example, salmonids use a
+wide range of aquatic environments, from open ocean to estuaries to inland rivers and
+lakes. It has been argued that each of these areas is essential to salmon during some
+point in their life. Therefore, any activity that occurs in this range of habitats could
+harm “those waters and substrate necessary to fish,” including fishing, shipping,
+farming, timber harvesting, and hydropower production. Others contend that only
+portions of these environments may be essential to salmon.
+
+The distinction between essential and non-essential habitat, however, is
+
+problematic. Managing an unbounded natural environment often necessitates
+drawing imaginary lines to regulate human activities within that environment. To
+protect fish and other marine life from harmful human activities, the MSFCMA
+required regional councils to describe and identify EFH. However, the unlimited
+ocean environment combined with limited scientific information about fish life
+histories and habitat needs can result in somewhat arbitrary definitions of essential .
+This ambiguity raises concerns among constituents about how regional councils are
+distinguishing EFH.
+
+Some fishery scientists express concern that regional councils have defined EFH
+
+for some species in overly broad terms. For example, the Pacific Regional Council
+defines EFH for salmonids to include all waters of the EEZ and all freshwater areas
+that contain or have contained salmonids. These scientists are concerned that
+
+46 50 C.F.R. §600.815.
+
+47 50 C.F.R. §600.815(a)(8).
+
+48 However, critics of this approach suggest that any distinction between “essential” and
+“non-essential” is substantially based on a highly anthropogenic view of animal behavior.
+
+ 
+ CRS-16
+
+regional councils have not distinguished between essential and non-essential parts
+of a range of habitat, choosing instead to define all habitat as essential. These
+scientists suggest that by perhaps modifying the definition of EFH, Congress could
+better direct how regional councils are to make EFH determinations. Some scientists
+suggest modifying §305(b) to include a simple statement that fish habitat is divided
+into areas that are essential and those that are non-essential; that an explanation be
+included in the FMP of the criteria by which these determinations are made; and that
+actions that damage EFH be described. Other scientists believe that attempts to
+divide habitat into essential and non-essential components would be unworkable
+(most notably because of the lack of scientific data) and create further delays in
+implementing EFH provisions. They support EFH designations based on available
+data and believe that NMFS/NOAA Fisheries and regional councils have
+appropriately used a precautionary approach in identifying EFH. In their opinion,
+regional councils did not define EFH arbitrarily; rather, regional councils used fish
+distribution as a proxy for EFH in defining the EFH boundaries. They assert that the
+controversy lies in where, within the bounds of EFH, fish distribution should be
+defined as essential . Because data are not available to ascertain the exact relationship
+between fish and habitat, they believe that most regional councils have correctly used
+stock distribution and density data to identify EFH. Moreover, they note that, as
+more and better data become available, EFH can be narrowed by revising the EFH
+provisions in FMPs.
+
+Other suggestions for identifying and describing EFH include the following:
+
+(1) because of its critical importance to fish survival, include all substrate areas that
+a demersal49 or non-demersal species uses during any part of its life history as EFH,
+and, where possible, divide into primary, secondary, and tertiary habitats;
+(2) distinguish between EFH and critical habitat, with critical habitats defined as
+those areas where significant ecological harm could imperil the species or stock in
+question;50 and (3) increase the strength of EFH provisions relating to state waters,
+non-fishing activities, and land-use practices that influence EFH.
+
+In addition to addressing the definition of EFH, some commercial fishing
+
+interests recommend that Congress define the context for judging harm . They note
+that, in North Pacific Regional Council discussions about EFH, each species may be
+viewed as part of the habitat for other species (because of predator-prey relations and
+other life history needs). Thus, they contend that plankton is part of the habitat for
+herring, herring is part of the habitat for salmon, salmon is part of the habitat for sea
+lions, etc., and the harvest of any species might constitute harm to another species.
+Moreover, they note that successful predators inevitably modify their environment
+to some degree, and fishermen function as predators in the marine environment.
+Fishing is not a benign activity — it causes change within the marine environment.
+In their opinion, these changes inevitably harm some species and benefit others.
+These commercial fishing interests believe that sustainability of the overall system
+should be the goal, and that Congress might consider clarifying the definition of
+
+49 Living near, deposited on, or sinking to the bottom of the sea.
+
+50 As noted above, the EFH regulations encourage regional councils to identify Habitat
+Areas of Particular Concern (i.e., rare or ecologically important areas of EFH) to focus EFH
+protection efforts.
+
+ 
+ CRS-17
+
+ harm , especially in terms of harm to EFH caused by fishing, as referred to at
+§307(a)(7).
+
+While not specifically addressed in the MSFCMA, data are critical for
+
+identifying and describing EFH. Whether constituencies perceive the EFH
+provisions as beneficial to fishery management or as restricting fishing opportunities,
+virtually all believe more research is required to better define the linkages between
+habitat and fishery productivity, determine the extent of harm caused by fishing and
+non-fishing activities, and assess the need for “protected areas” to protect habitat and
+conserve fish stocks.
+
+Various interests commend ongoing efforts to describe and identify EFH, but
+
+note that additional research is needed to understand the habitat requirements of fish
+at various life history stages; the role of submerged aquatic vegetation, reefs, and
+“cover” in salmon streams, mangrove forests, and wetlands; and the linkages between
+habitat, fishery production, and ecosystem health; as well as to map different habitats.
+Thus, it is likely that fishery scientists, environmental groups, and commercial and
+recreational fishing interests will ask Congress to consider authorizing research
+focused on habitat and its role in ensuring sustainable fisheries.
+
+ Marine Protected Areas. 51 A marine protected area (MPA)52 can be
+
+considered to be any part of the marine environment that is selectively managed to
+offer enhanced protection of the plants, animals, and/or cultural features in that
+area.53 An MPA could include underwater areas close to the coast or offshore; reefs
+and seagrass beds; and shipwrecks and archaeological sites. MPAs could also
+include estuarine and intertidal areas, including tidal lagoons, mudflats, saltmarshes,
+mangroves, and rock platforms. Different types of U.S. MPAs include national
+marine sanctuaries, fishery management zones, national seashores, national parks,
+national monuments, critical habitats, national wildlife refuges, national estuarine
+research reserves, state conservation areas, state reserves, and many others. The
+MSFCMA neither specifically addresses MPAs nor prevents regional councils from
+designating MPAs. Under the MSFCMA, MPAs could be used in combination with
+
+51 For more detailed information on this topic, see CRS Report RL32154, Marine Protected
+Areas: An Overview , by Jeffrey Zinn and Eugene H. Buck; and National Research Council,
+ Marine Protected Areas: Tools for Sustaining Ocean Ecosystems , Committee on the
+Evaluation, Design, and Monitoring of Marine Reserves and Protected Areas in the United
+States, Ocean Studies Board, Commission on Geosciences, Environment, and Resources
+(Washington, DC: National Academy Press, 2001), 272 pp.
+
+52 The creation of MPAs was promoted by President Clinton’s signing of Executive Order
+13158 (May 26, 2000) on Marine Protected Areas. For the text of this order, see
+[http://www.mpa.gov/executive_order/execordermpa.pdf], visited Aug. 11, 2004. This order
+also established a National MPA Center to provide federal, state, territorial, tribal, and local
+governments with the information, technologies, and strategies to support an MPA system.
+For general background on federal MPA activities, see also [http://www.mpa.gov], visited
+Aug. 11, 2004.
+
+53 See [http://www.mpa.gov/information_tools/archives/what_is_mpa.html#varying], visited
+July 2, 2004.
+
+ 
+ CRS-18
+
+traditional fishery management tools as one approach to rebuilding fisheries and
+protecting EFH. (See §§304(e) and 305(b), respectively, of the MSFCMA.)
+
+MPAs may enhance fisheries by protecting fish spawning aggregation and
+
+nursery areas, such as seagrass beds, mangrove communities, and reefs. MPAs may
+play a role in rebuilding fish stocks by providing a haven for fish to grow and
+reproduce. Adult fish may then move from MPAs into adjoining areas, enhancing
+fishery production. Proponents of MPAs claim that protected areas may be beneficial
+in curbing overfishing, rebuilding depleted stocks, preserving ecosystem integrity,
+and protecting EFH. Specifically, they suggest that MPAs can prevent overfishing
+by providing a hedge against uncertain stock assessments, rebuilding depleted stocks
+by allowing older and more reproductive individuals to survive, alleviating the
+impacts of fishing on habitat, providing reference sites to assess fishing and non-
+fishing impacts, and providing a refuge for bycatch species.54
+
+Some environmental groups believe that MPAs are a promising management
+
+tool, but one highly subject to political manipulation. These interests assert that, for
+MPAs to be effective, a significant portion of EFH should be included in a protected
+area. They contend, however, that commercial and recreational fishing interests will
+use political pressure to restrict MPA classification to suboptimal habitat. To ensure
+that MPAs provide real benefits for fish production and habitat protection, some of
+the more vocal MPA proponents recommend that exploitation of fish stocks in
+protected areas be eliminated or limited to catch-and-release sportfishing.
+
+Other respondents suggest that all seagrass beds, mangrove areas, and reefs
+
+should be considered for listing as MPAs. They believe that “core” areas can be
+identified and should be closed to all activities, except carefully monitored scientific
+investigation.55 For coral reefs, some respondents contend that one of the most
+detrimental activities to fish populations is spear fishing with the aid of scuba gear.
+They recommend that this activity be eliminated if heavily fished coral reefs are to
+recover.
+
+Some commercial and recreational fishing interests are likely to counter
+
+proponents’ claims by noting the weakness of scientific proof that MPAs accomplish
+what their supporters contend. They and other opponents are likely to ask Congress
+to consider the economic losses that may result from designating MPAs and closing
+areas to fishing and other uses. These groups will likely ask for more scientific
+research before closing areas, reducing fishing opportunity, and imposing economic
+
+54 Some fishery scientists note that the scallop closed-area on Georges Bank highlighted the
+potential benefits of one approach to MPAs. After fishing was prohibited in this area for
+several years, bottom trawl survey data indicated a buildup of yellowtail flounder and large
+numbers of scallops.
+
+55 Certain areas of the marine environment have been closed to all or specific activities for
+a variety of reasons (e.g., marine sanctuaries designated under the Marine Protection,
+Research, and Sanctuaries Act (16 U.S.C. §§1431, et seq.); regulatory closures in the Bering
+Sea and Aleutian Islands to protect crab, salmon, herring, and marine mammals; the Oculina
+Banks Experimental Reserve established by the South Atlantic Regional Council; and the
+Tortugas Shrimp Sanctuary).
+
+ 
+ CRS-19
+
+costs on users. These groups also are concerned about the permanence of MPA
+designations and desire the flexibility through adaptive management to change MPA
+boundaries and regulations in response to an evolving understanding of MPAs. They
+also note that while MPAs may be a useful tool within a traditional management
+system, regional councils should not be mandated to use MPAs.
+
+Moreover, some critics of MPAs contend that, while establishing a reserve to
+
+protect and maintain sessile or largely non-mobile stocks or species may be prudent
+in certain circumstances, highly mobile animals do not recognize protected area
+boundaries. Thus, they argue that extreme protective measures, such as no-take
+zones, may be ineffective for migratory fish.
+
+Finally, some scientists note that although MPAs may initially benefit depleted
+
+stocks by allowing rebuilding, additional research is needed on the management
+problems created by overcrowding and increased density of concentrating fishing
+vessels in the remaining smaller open areas when fishing grounds are closed for an
+extended period of time. They note that scientific studies already suggest that
+overcrowded and high-density fishing can lead to health problems and poor
+reproduction in marine species. They conclude that periodic and monitored fishing
+in closed areas may be appropriate after rebuilding has occurred.
+
+Other comments include the following: (1) managers should also consider the
+
+broad array of economic benefits and costs, including the potential growth of
+non-extractive ecotourism in association with MPAs (e.g., displaced fishermen might
+become involved in non-extractive dive trips); (2) closures should affect all sectors
+equally (some commercial fishermen assert that current closed areas have resulted
+in highly unequal treatment among gear sectors); (3) MPAs and their regulations
+should be carefully evaluated for their potential to displace subsistence/traditional
+and customary use fishermen; and (4) designations of MPAs should be made by
+regional councils, not Congress (i.e., local decisions, not national control).
+
+Discussions about EFH include continuing debate over situations where MPAs
+
+might be an appropriate means to conserve stocks and protect habitat. The level of
+protection can vary among different types of MPAs. Some MPAs allow a wide range
+of activities (including fishing) while others are more stringently regulated, possibly
+prohibiting all human activities. The size of an MPA depends on its intended
+purpose. MPAs created to protect shipwrecks can be quite small, while those that
+aim to protect whole ecosystems may be much larger.
+
+Issues that Congress may face include whether the MPA concept should be
+
+codified in law, the rationale for creating MPAs and methods for selecting which
+areas to protect, the types of activities that would be permitted or prohibited and why,
+a review of existing closed areas (including assessing their effectiveness), and
+research to determine the sociocultural and economic benefits and costs of creating
+MPAs.
+
+The difference between no-take marine reserves (areas closed to all resource
+
+extraction) and multiple-use areas (areas with gear-type or time/area restrictions, but
+where limited fishing is permitted) is one of the more controversial issues in the
+debate over the merits of designating MPAs. Fishing groups would be likely to ask
+
+ 
+ CRS-20
+
+for consideration of the differences between recreational and commercial fishing, and
+the relative effects of various types of commercial gear and operational
+characteristics.
+
+ Overfishing. Environmental groups have expressed concern over regulatory
+
+exemptions to the national standard that requires conservation and management
+measures to prevent overfishing.56 They suggest that, by allowing overfishing to
+continue, NMFS’s/NOAA Fisheries’ interpretation weakens the law and endangers
+depleted stocks, and that economic returns are being valued over ecological concerns.
+Congressional concern has also been expressed over what is perceived as
+NMFS/NOAA Fisheries permitting regional councils to miss deadlines and delay
+actions to end overfishing and rebuild stocks.57 Environmental groups contend that,
+rather than using 10 years as an upper limit on stock recovery, regional councils have
+uniformly adopted 10 years as a standard recovery period. Environmental groups
+also suggest that fishery rebuilding plans, in some instances, do not account for
+overfishing caused by recreational harvest.58 The Mid-Atlantic Regional Council’s
+FMP for summer flounder, for example, contains no additional management
+measures to address overfishing in the recreational fishery. NMFS/NOAA Fisheries
+has taken public comments on proposed regulatory revisions to guidelines on
+overfishing,59 but no final rule has been published. In light of the continued struggles
+
+56 50 C.F.R. §600.310(d)(6). NMFS/NOAA Fisheries explains that, because harvesting one
+species in a mixed-stock complex at its optimum yield may result in overfishing of another
+stock in the complex, regional councils may permit overfishing only if all of the following
+conditions are satisfied: (i) it will result in long-term net benefits to the nation; (ii)
+mitigating measures have been considered and a similar level of long-term net benefits
+cannot be achieved by modifying fleet behavior, gear selection/configuration, or other
+technical characteristic in a manner such that no overfishing would occur; and (iii) the
+resulting rate or level of fishing mortality will not cause any species or evolutionarily
+significant unit thereof to require protection under the ESA. NMFS/NOAA Fisheries,
+however, reports that this exception has never been applied and, for that reason, has not been
+successfully challenged in court by environmental interests ( Natural Resources Defense
+Council v. Evans , 243 F.Supp.2d 1046 (N.D.Cal., 2003); Natural Resources Defense
+Council v. Evans , 168 F.Supp.2d 1149 (N.D.Cal., 2001)).
+
+57 For example, the Pacific Regional Council proposed a groundfish fishery FMP that would
+arguably have perpetuated overfishing the mixed-stock groundfish fishery. Proponents of
+this management approach state that criticism oversimplifies a complex management plan,
+contending that substantial harvest reductions have been made for two of the three species
+designated as overfished. The third (Pacific ocean perch) is a long-lived species, whose
+biomass estimate is uncertain, and may take more than 10 years to rebuild. Thus, these
+proponents argue that the Pacific Regional Council’s harvest policy complies with the
+national standards (16 U.S.C. §1851) under the MSFCMA.
+
+58 Some contend that, in certain South Atlantic and Gulf of Mexico fisheries, sport anglers
+far outfish commercial harvesters for those species targeted by sportfishermen. See F. C.
+Coleman et. al., “The impact of United States recreational fisheries on marine fish
+populations,” Science , Aug. 26, 2004.
+
+59 See [http://www.nmfs.noaa.gov/sfa/domes_fish/NS1/recommendations.version3.pdf],
+visited Sept. 1, 2004.
+
+ 
+ CRS-21
+
+with this issue, Congress may ultimately decide to review the MSFCMA’s
+requirements for rebuilding and recovery of overfished stocks.60
+
+Other concerns include (1) continued fishing above the rate that produces
+
+maximum sustainable yield; (2) lack of status assessments for many managed
+species; (3) failure of some regional councils to establish criteria to identify when a
+stock is overfished; (4) failure of some regional councils to ensure overfished stocks
+will be rebuilt within the time frames established by the MSFCMA; (5) delay of
+rebuilding plans for stocks needing immediate protection; and (6) lack of overfishing
+definitions that are based on the biology of each stock. Additional comments include
+(1) the only way to rebuild a stock is to declare a moratorium and wait for the natural
+rebuilding cycle to occur, and then resume fishing; and (2) regional councils should
+be penalized for failure to meet targets to curb overfishing.
+
+ Harmful Non-Native Species. Because of the potential for harm to fishery
+
+resources, some believe that prevention and control of harmful aquatic non-native
+species, such as the European green crab ( Carcinus maenas ), should be given some
+consideration during reauthorization of the MSFCMA. For example, potential
+invasive species concerns might be identified as a discretionary issue for discussion
+in FMPs. For more information on non-native species, see CRS Report RL30123,
+ Harmful Non-Native Species: Issues for Congress , by M. Lynne Corn, Eugene H.
+Buck, Jean Rawson, and Eric Fischer.
+
+ Management Issues 
+
+Commercial and recreational fishing interests, environmental groups, and
+
+fishery scientists voiced concern regarding the need to clarify and/or modify the
+scope and goals of fishery management under the MSFCMA. These concerns range
+from narrow suggestions for improving aspects of fishery management to broad
+commentary on the overall goals of MSFCMA management.
+
+ Data Collection and Management. Section 402 of the MSFCMA provides
+
+authority for regional councils to develop and implement information collection
+programs that would be beneficial in developing FMPs or determining if a fishery
+needs to be managed.
+
+Recreational and commercial fishing interests express an interest in more data,
+
+including sociocultural data, to improve fishery management. In their view, more
+information would promote a better understanding of the economic and sociocultural
+contributions of commercial and recreational fishing enterprises as well as the
+businesses and industries that support both sectors.61 The absence of adequate data
+makes it difficult for fishery managers to arrive at fair and equitable decisions about
+matters that affect commercial and recreational fishing.
+
+60 16 U.S.C. 1854(e).
+
+61 However, socioeconomic data collection may have a disparate impact upon small entities,
+while larger companies can spread such costs over diversified operations. In this respect,
+data collection efforts may conflict with the MSFCMA’s National Standard #8 relative to
+protecting communities.
+
+ 
+ CRS-22
+
+Some environmental groups believe that the present state of knowledge
+
+regarding catch in recreational fisheries and bycatch in all fisheries is poor and needs
+to be greatly improved to prevent overfishing and to minimize bycatch. These groups
+assert that many regional councils use the lack of data to justify postponing action in
+a number of areas such as identifying maximum sustainable yield (MSY) or optimum
+yield (OY); determining the status of many stocks; and proposing measures to
+minimize bycatch and the harm caused by fishing gear on EFH. These groups
+suggest that additional funding is necessary to support these research efforts so that
+the MSFCMA can be properly implemented and fisheries can be sustainably
+managed. These groups are specifically concerned with identifying and quantifying
+the amount and type of bycatch occurring in all fisheries.
+
+Fishery managers suggest that if more information is going to be collected,
+
+particularly on sociocultural and economic aspects, creative ways will need to be
+developed to collect useful information with minimal additional burden. They
+believe that programs that collect unverified data from the industry are likely to
+impose a high burden but result in low-value information (i.e., data of questionable
+validity).62 They assert that the Paperwork Reduction Act (44 U.S.C. §§3501-3520)
+often hinders efficient collection of information. Moreover, in their opinion, because
+the MSFCMA ties data collection to a specific FMP, fragmented and inconsistent
+data result. They posit that future versions of the MSFCMA should encourage
+interagency and inter-regional cooperation on data collection, satisfying specific FMP
+needs within an overarching plan that results in useful information.
+
+Another source of information, suggested by some commercial fishermen, is
+
+fishermen themselves. They believe that fishermen offer a largely untapped source
+of data, especially about how many of what species are found when and where. They
+contend that these anecdotal data are just as useful as annual or triennial trawl
+surveys, and that fishermen should be integrated into data collection and management
+efforts.
+
+The types of information collection and analysis that all of these groups may
+
+request include (1) a needs assessment of the types of data required to manage
+recreational and commercial fisheries; (2) a needs assessment of the types of
+economic and social data (including data on industries that support recreational and
+commercial fisheries) needed to make management decisions;63 (3) increased
+collection of commercial and recreational fish harvest data (including bycatch); and
+(4) increased collection of information to support development, implementation, and
+management of individual fishing and bycatch quota programs. Moreover, a variety
+of fishing interests are likely to ask Congress for increased attention to collecting
+information on the indirect but significant impacts of fishery management policy on
+such related businesses as gear manufacturers, local restaurants, ice houses, and other
+businesses that support recreational fishing. Contrary to these suggestions, some
+
+62 However, sociocultural and economic scientists are well aware of potential problems with
+data bias and have developed methods for dealing with these concerns.
+
+63 Others argue that a multitude of these needs assessments have been completed in the last
+decade, and the types of information needed are well known; any additional needs
+assessments would simply delay needed data collection.
+
+ 
+ CRS-23
+
+commercial and recreational fishermen may object to expanded data collection, citing
+their belief that fishing is already heavily regulated and that increased reporting
+requirements would add unnecessary costs and other burdens.
+
+ The Scientific Basis for Policy. Commercial fishing interests suggest that
+
+weak fishery data hinder decision-making and result in flawed regulations. While
+protecting habitat and ecosystems are reasonable objectives, they assert that there is
+no way to implement management objectively with inconclusive scientific
+information about ecosystems and the impacts of fishing on habitat. They suggest
+that Congress modify the MSFCMA to focus on gathering more tangible information
+upon which to base regulations. The environmental community would likely use this
+same argument to promote even more stringent fishery regulations, noting that the
+“precautionary approach” prescribes more conservative management in the face of
+uncertainty.64 The crux of the issue is, what is meant by this phrase, and how
+“precautionary” management ought to be when dealing with imprecise data and
+variable fish stocks.
+
+Some in the environmental community agree that there is a serious lack of
+
+fishery data and that steps should be taken to obtain more and better data. However,
+they generally are concerned that this lack of data not be used as an excuse to delay
+conservation measures. In their opinion, delays to obtain more data have caused
+declines of some managed fish and other marine species to population levels
+requiring Endangered Species Act protections. They believe that inaction premised
+on lack of information is unsound, contending that the data are sufficient for
+NMFS/NOAA Fisheries and regional councils to take steps to protect EFH and
+ecosystems, and concluding that a precautionary approach makes the use of the best
+available scientific information. Others contend that NMFS/NOAA Fisheries
+currently advocates risk-averse decision-making; nonetheless, they recommend that
+Congress specifically endorse risk-averse decision-making, especially where limited
+data and information are available.
+
+Finally, other scientists note that best available scientific information should
+
+also include sociocultural information. However, in their opinion, there are no
+rigorous social and culture impact assessments in current FMPs. They assert a
+critical need for sociocultural and socioeconomic data, that must be collected before
+social impact analyses can be conducted. Therefore, these scientists might ask
+Congress to consider authorizing research programs to collect and analyze
+sociocultural information.
+
+ Reliability of Management Models. Section 404(c)(1) of the MSFCMA
+
+establishes requirements for the Secretary to initiate and maintain fishery research to
+carry out the purposes, policy, and provisions of the Act.
+
+Some fishery managers note a concern regarding the need for additional data to
+
+verify the assumptions used in stock assessment models. Particularly, they assert that
+the management analyses garnered from Virtual Population Analysis (VPA) models
+
+64 Others argue that the time has come to shift the burden of proof to the resource users and
+away from fishery managers and scientists.
+
+ 
+ CRS-24
+
+could be improved by expanding the use of age-growth65 information. To address
+these concerns, some fishery managers suggest that Congress might consider
+authorizing funds for expanded age and growth research. For example, regional age
+and growth research centers could coordinate information among state and federal
+agencies. Fishery managers suggest that a central data clearinghouse would provide
+consistent fishery data, avoid duplication of effort, and reduce costs.
+
+Some environmental groups are concerned that fishery managers do not have
+
+the necessary information to determine valid MSY values and the status of many
+stocks. They are concerned that assumptions made by regional councils may not be
+scientifically justifiable and may, therefore, result in risk-prone management that
+increases the likelihood of overfishing. In addition, some fishery scientists note that
+it is not just biological or population dynamic models that are problematic, but that
+social and economic impact assessment models also have serious deficiencies.
+
+The National Academy of Sciences’ Committee on Fish Stock Assessment
+
+Methods reviewed existing stock assessment methods and considered alternative
+approaches.66 The Committee found that, while simple models are useful, more
+complex models are needed to better quantify unknown aspects of the system and to
+address the long-term consequences of specific decision rules. Their retrospective
+analyses showed that persistent over- or under-estimation can occur over a number
+of assessment years, regardless of the assessment model. In their simulations, model
+performance became more erratic as more variability or errors were introduced into
+the data. They recommended that different assessment models be used to analyze the
+same data as a means to identify poor quality data. In addition, the Committee
+suggested that greater attention be devoted to including independent estimates of
+natural mortality and its variability in assessment models. Specifically, they
+recommended (1) using Bayesian methods and other statistical techniques to
+incorporate realistic uncertainty into stock assessment models; (2) developing better
+assessment models for recreational fisheries and methods to evaluate the impacts of
+the quality of recreational data on stock assessments; (3) accounting for effects of
+directional changes in environmental variables (e.g., climate change) in new models;
+and (4) developing new means to estimate changes in average “catchability,”
+selectivity, and mortality over time, rather than assuming that these parameters
+remain constant.
+
+ Ecosystem vs. Single-Species Management. Fishery scientists suggest
+
+adopting ecosystem-based management, notably for defining EFH. They argue that
+habitat use by various species is a composite and involves more than the life cycle
+
+65 Age-growth analysis uses fish scales and otoliths (“ear” bones used for balance and
+orientation) to assess age relative to length. These hard structures have annual growth rings,
+much like rings in a tree trunk, that can be used to estimate the age of a fish. However, some
+fishery scientists note that traditional age-growth research, using hard parts to discern fish
+age, is not applicable in tropical regions because fish growth is not subject to discrete
+seasonal changes. In tropical regions, “length-based” methods are used.
+
+66 National Research Council, Committee on Fish Stock Assessment Methods, Improving
+Fish Stock Assessments (Washington, DC: National Academy Press, 1998; hereafter “Stock
+Assessments”).
+
+ 
+ CRS-25
+
+of a single species. These scientists see the need to develop fundamentally new
+concepts for dealing with trans-boundary fishery management and EFH issues. In
+moving toward ecosystem management, scientists suggest that Congress transform
+EFH regulations into national guidelines for instituting ecosystem-based
+management.
+
+Currently, the MSFCMA divides the U.S. EEZ into eight regional management
+
+areas. These areas generally extend from 3 miles off the coast out to 200 miles
+offshore and are managed by the eight regional councils. Fisheries within 3 miles of
+the coast are managed under state authority. Fishery scientists suggest that, because
+of the difficulty in subdividing ecosystems for management purposes, Congress
+should redefine these management zones. These scientists suggest that unifying
+fishery management across state and federal waters is the most important step in
+moving toward ecosystem-based management.67 Additionally, they suggest that
+artificial boundaries, such as those dividing the Atlantic portion of the nation’s EEZ
+into three regional fishery management areas, impair management of trans-boundary
+stocks. Redefining regional fishery management areas to reflect an ecosystem-based
+approach would require major amendment of the MSFCMA. Sections applicable to
+such amendment would likely include §303(a) on FMPs and §305(b) on EFH.
+
+A more formal approach for introducing ecosystem considerations into fishery
+
+management is described in the final report of NOAA Fisheries’ Ecosystem
+Principles Advisory Panel.68 In 1996, Congress requested an assessment of the extent
+to which ecosystem principles are currently applied in fishery research and
+management, and recommendations for how best to integrate ecosystem principles
+into future fishery management and research.69 The panel noted that:
+
+a comprehensive ecosystem-based fishery management approach would require
+managers to consider all interactions that a target fish stock has with predators,
+competitors, and prey species; the effects of weather and climate on fishery
+biology and ecology; the complex interactions between fishes and their habitat;
+and the effects of fishing on fish stocks and their habitat.70
+
+The panel considered full implementation of the overfishing, bycatch, and EFH
+provisions of the Sustainable Fisheries Act to be prerequisites to ecosystem-based
+fishery management.
+
+In their report, the panel described the enormous task of managing at the
+
+ecosystem level and recognized that, in most cases, then-current data were
+insufficient. However, it stressed that there are practical ways to use the information
+
+67 On the other hand, unifying management may mask a simultaneous need to recognize the
+many small ecotones that would benefit from being considered as semi-separate units rather
+than simply parts of a great whole.
+
+68 Ecosystem Principles Advisory Panel, Ecosystem-Based Fishery Management: A Report
+to Congress , Nov. 1998 (hereafter “Ecosystem Management”). The text of this document
+can be viewed at [http://www.nmfs.noaa.gov/sfa/EPAPrpt.pdf], visited Aug. 11, 2004.
+
+69 Mandated by the 1996 SFA amendments to the MSFCMA, §406, fishery systems research.
+
+70 Ecosystem Management, p. 1.
+
+ 
+ CRS-26
+
+that is available and recommended the use of fishery ecosystem plans (FEPs) to
+further incorporate ecosystem principles into FMPs. The FEP would document the
+structure and function of the ecosystem in which fishing activities occur as well as
+provide information to managers about the effects of their decisions on other
+components of the ecosystem and the effects of other ecosystem components on
+fisheries.71 The primary purpose of the FEP would be to allow regional councils to
+prescribe how fisheries will be managed from an ecosystem perspective.72
+
+The panel recommended that Congress require NMFS/NOAA Fisheries to
+
+develop FEP guidelines and each regional council to develop an FEP for the
+ecosystem(s) under its jurisdiction. It stated that each FEP should require, at least,
+eight actions by regional councils:
+
+1.
+
+Delineate the geographic extent of the ecosystem, including the biological,
+chemical, and physical dynamics, and use a zone-based management
+approach to designate geographic areas for prescribed uses;
+
+2.
+
+Develop a conceptual model of the food web;
+
+3.
+
+Describe the habitat needs of different life history stages for all plants and
+animals that represent the “significant food web” and how these habitat
+needs are considered in conservation and management measures;
+
+4.
+
+Calculate total removals (including incidental mortality) and show how
+this relates to standing biomass, production, optimum yields, natural
+mortality, and trophic structure;
+
+5.
+
+Assess how uncertainty is characterized and what kind of buffers against
+uncertainty are included in conservation and management actions;
+
+6.
+
+Develop indices of ecosystem health as targets for management;
+
+7.
+
+Describe available long-term monitoring data and how they are used; and
+
+8.
+
+Assess the ecological, human, and institutional elements of the ecosystem
+which most significantly affect fisheries, both within and outside Regional
+Council/Department of Commerce authority. Included should be a strategy
+to address those influences to achieve both FMP and FEP objectives.
+
+Panelists suggest that FEPs could also facilitate learning about the ecosystem
+
+and provide for iterative and adaptive management to promote long-term sustainable
+harvests. The FEP concept might not be marine ecosystem management; rather, it
+could be a way to formally include ecosystem knowledge and document how this
+information is used to manage living marine resources. According to panelists, FEPs
+could also help achieve the requirements of the Sustainable Fisheries Act to develop
+a comprehensive understanding of the limits of a renewable resource, and use that
+knowledge to design a socially and economically stable fishery, balancing short-term
+minuses with long-term pluses. Recognizing that a great deal of knowledge about
+how fisheries function within an ecosystem may be currently underused, FEPs may
+offer ways to better use what is known and to incorporate new knowledge.
+
+The panel believed that, while much of what it recommended could be
+
+accomplished under current mandates, directives from Congress would hasten
+
+71 Ecosystem Management, p. 3.
+
+72 Ecosystem Management, p. 28.
+
+ 
+ CRS-27
+
+application of these principles and ensure universal application by the regional
+councils. The panel concluded that:
+
+if fishery management is to further incorporate ecosystem principles, Congress
+must provide a specific mandate to NMFS and the regional councils to do so and
+must fund the scientific infrastructure required to support the decision-making
+process. Requiring regional councils to prepare FEPs provides a mechanism to
+focus and inform fishery management, to measure progress toward
+implementation of ecosystem-based fishery management, to identify research
+needs and ultimately to insure healthy and productive ecosystems.73
+
+Some environmental groups believe that ecosystem-based management of fish
+
+stocks, rather than single-species management, is necessary to promote sustainable
+fisheries and to protect non-commercial species that may be affected by fishing. As
+a means to protect marine ecosystems, these groups might request that Congress
+require regional councils to prepare ecosystem management plans and to ensure that
+FMPs are consistent with ecosystem plans.
+
+Critics of current management contend that single-species management,
+
+especially with different daily allowable catch rates, increases regulatory discards.
+They also suggest that the definition of fishery 74 could be amended to “one or more
+stocks, or inter-related species , of fish which can be treated as a unit.” Some believe
+that this modification would facilitate the shift from single-species to ecosystem-
+based management.
+
+It should be noted that the National Academy of Sciences concluded that single-
+
+species assessments currently provide the best approach for assessing population
+parameters and providing short-term forecasting and management advice.75 The
+NAS committee stated that recent interest in bringing ecological and environmental
+considerations and multi-species management interactions into stock assessments
+should be encouraged, but not at the expense of reducing the quality of stock
+assessments.76
+
+ Decision-Making by Regional Councils. Section 302 of the MSFCMA
+
+establishes eight regional fishery management councils, and defines requirements for
+membership, regional council functions, transaction of business, and disclosure of
+financial interest and recusal.
+
+73 Ecosystem Management, p. 37.
+
+74 MSFCMA §3(13)(A) defines the term fishery as one or more stocks of fish which can be
+treated as a unit for purposes of conservation and management and which are identified on
+the basis of geographical, scientific, technical, recreational, and economic characteristics.
+However, several other uses of fishery (e.g., MSFCMA §§303(2), 303(5), and 303(b)(6),
+and more indirectly MSFCMA §§3(9) and 305(a)(3)) broaden this definition to include
+elements of the fleet such as gear and vessels. These inconsistencies could merit attention
+during reauthorization.
+
+75 Stock Assessments.
+
+76 Stock Assessments, p. 4.
+
+ 
+ CRS-28
+
+Subsection 302(j) describes the requirements for council members to disclose
+
+financial interest and recuse themselves from decisions in which they have a financial
+stake. As in previous reauthorizations of the MSFCMA, perceived conflicts of
+interest by regional council members is cause for concern among recreational and
+commercial fishermen. Some groups believe that because of the close relationship
+with the fishing industry, regional councils are unable to take the necessary steps to
+prevent overfishing, rebuild stocks in a timely manner, and properly regulate gear
+that catches large amounts of bycatch and damages EFH. At issue is whether
+decision-making by individuals with a vested financial interest in a fishery can be
+impartial.
+
+In addition to current disclosure and recusal requirements, Congress may be
+
+asked to consider other measures to minimize conflict-of-interest concerns.
+Suggestions for preventing financial conflicts-of-interest range from prohibiting
+individuals with related financial interests from making fishery management
+decisions to requiring regional council members to swear compliance with federal tax
+and banking laws. Commercial fishermen suggest that regional council membership
+be limited to individuals with practical knowledge of fishing operations, specifically
+excluding industry representatives such as executive directors, lawyers, and lobbyists.
+However, increasing financial disclosure requirements or limiting the type of
+individual allowed to serve on regional councils could make it difficult to obtain
+knowledgeable and willing nominees for regional council membership.
+
+Some fishery scientists contend that conflict of interest is not the problem; rather
+
+it is that private and public interests are in conflict. Instead of mandating an
+unattainable impartiality, they suggest empowering decision-makers who share the
+public interest. That is, decision-makers should bear the consequences of their
+decisions in ways consistent with the public interest. This can be achieved, they
+suggest, by reconfiguring the incentive structure for decision-makers. In their
+opinion, the misalignment of public and private interests is, in large part, due to (1)
+shortsightedness on the part of resource users, elected representatives, and agency
+heads; and (2) the decoupled costs and benefits of fishery policies and programs.
+They contend that shortsightedness on the part of resource users can only be
+overcome by giving them more secure claims to future outcomes in fisheries (i.e.,
+some form of property rights). The effects of shortsightedness by politicians and
+agency heads, they contend, can be overcome by insulating fishery decision-making
+from political influence. Finally, they suggest that the benefits and costs of fishery
+policy can be more closely coupled by the use of cost-recovery mechanisms, such as
+fees and taxes.
+
+Some also support a review of MSFCMA provisions relating to regional council
+
+membership to ensure that all parties interested in U.S. fisheries are adequately
+represented. Specifically, environmental groups expressed concern that their
+interests are inadequately represented on most regional councils, and suggest that
+Congress should consider legislative changes to the MSFCMA to ensure that regional
+councils are more broadly representative of the public interest in making fishery
+management decisions that benefit the nation. Others suggest that there is a need for
+greater representation of non-fishing interests, such as seafood consumers and
+environmentalists, as well as increased oversight by independent scientists. The
+
+ 
+ CRS-29
+
+Bureau of Land Management’s Resource Advisory Councils may provide an
+alternative model for balancing various constituencies and their influence.77
+
+Closely related to the issue of financial conflict of interest is the issue raised by
+
+some commercial fishermen who questioned whether regional council members, who
+work only part-time on regional council matters, are able to make impartial and
+knowledgeable decisions affecting management of the nation’s marine fisheries.
+They contend that regional council members who work in the fishing industry are
+likely to make decisions that favor the interests of their employers. To prevent this
+bias, they suggest making regional council membership a full-time position, with
+members solely dedicated to managing fisheries.
+
+Conversely, other fishermen argue that regional councils already have full-time
+
+administrative and professional staff to assist and support council members, and that
+council membership should not be a full-time position. They assert that individuals
+actively employed in the fishing industry tend to be the most knowledgeable.
+Concern was also expressed regarding who the pool of potential regional council
+members might include if membership became a full-time profession. It was
+suggested that successful fishermen and businessmen would not be as interested in
+becoming regional council members were it a full-time job. Another concern is that
+the judgment of full-time regional council members could become clouded if they
+were constantly worried about keeping their position on the regional council.
+Furthermore, some social scientists suggest that there is greater likelihood of
+compliance if user groups participate in the regulatory process. They suggest that
+making regional council membership a full-time position would preclude user groups
+from participating on the regional council. Moreover, regional council membership
+is currently limited to a term of three years. This term-limit, some suggest, provides
+sufficient means for different perspectives and experience to be involved in the
+fishery management process.
+
+The MSFCMA provides for NMFS/NOAA Fisheries to have a voting seat on
+
+each regional council, with the NOAA General Counsel participating in regional
+council business. However, the MSFCMA lacks provisions for independent legal
+advice or counsel for regional councils. Some commercial and recreational
+fishermen express concern that the NOAA General Counsel, who represents the
+interests of NMFS/NOAA Fisheries, often dictates fishery policy in its legal advice
+to regional councils on measures under consideration. They contend that the public
+interest would be better served by independent legal advice, and suggest that
+Congress amend the MSFCMA to authorize independent legal counsel for regional
+councils.
+
+Others doubt that authorizing independent legal counsel would lead to better
+
+decision-making. They assert that this could unnecessarily delay decision-making
+and increase the involvement of the courts in fishery management. They also
+contend that it could be costly to change the process, and that the NOAA General
+Counsel provides objective legal interpretations. Some also noted that regional
+
+77 For background on Resource Advisory Councils, see [http://www.blm.gov/rac/], visited
+on Aug. 26, 2004.
+
+ 
+ CRS-30
+
+councils are not currently prohibited from hiring lawyers to work on the regional
+council staff, providing legal advice as necessary.
+
+Additional comments concerning regional council decision-making include the
+
+following: (1) the role of state governors in the regional council appointment process
+should be reduced, and at-large nominations should be solicited through an
+application process directly to the Secretary of Commerce; (2) many user groups feel
+that they are under-represented on regional councils and that their expertise is under-
+used; (3) fishermen should act as paid consultants to the regional councils, providing
+advice, but not voting; and (4) regional councils are not adequately funded for their
+workload, and need more staff.
+
+ Highly Migratory Species. Section 304(g)(1) of the MSFCMA authorizes
+
+the Secretary of Commerce to prepare or amend FMPs for Atlantic highly migratory
+species.78
+
+Currently, NMFS/NOAA Fisheries is responsible for implementing MSFCMA
+
+provisions that apply to highly migratory species (HMS). Management actions seek
+to “ensure conservation and promote the achievement of optimum yield of such
+species throughout their range, both within and beyond the exclusive economic
+zone.”79 FMPs for Atlantic HMS are developed by NMFS/NOAA Fisheries in
+consultation with advisory panels created by NMFS/NOAA Fisheries and composed
+of constituents from the recreational, commercial, environmental, and scientific
+communities.
+
+Some recreational fishermen and environmental groups are concerned about the
+
+effectiveness of the current management system. They observe that Secretarial
+management has allowed continued declines in Atlantic HMS. This concern stems
+from the perception that NMFS/NOAA Fisheries lacks the funding and staff to
+properly manage Atlantic HMS, and that current management favors commercial
+fishing. These groups may suggest that Congress review the effectiveness of
+NMFS/NOAA Fisheries management of HMS. Others in the recreational fishing
+community may suggest returning management of all HMS fisheries, especially
+billfish, tuna, and swordfish, to regional council jurisdiction. Some fishery managers
+note that, if Congress decides to return HMS management to the regional councils,
+more efficient and effective guidelines for developing joint regional council FMPs
+might be needed.
+
+Others suggest that Congress authorize a regional council-like process for
+
+managing HMS. They assert that NMFS/NOAA Fisheries routinely ignores the
+advice of its advisory panels and non-NMFS/NOAA Fisheries scientists. They also
+contend that giving authority back to the regional councils would be problematic as
+well, given how poorly the regional councils have worked together in the past.
+
+Some recreational fishermen and environmental groups express the need for
+
+special management zones along the entire Atlantic and Gulf of Mexico coast, where
+
+78 Highly migratory species include tuna, marlin, oceanic sharks, sailfishes, and swordfish.
+
+79 MSFCMA §102.
+
+ 
+ CRS-31
+
+longline gear would be prohibited for a specific distance from shore. This is
+necessary, in their opinion, because longline fisheries have depleted Atlantic HMS.
+Moreover, they stress that the dimensions of the management zone should be set by
+fishery scientists, not fishery managers. Commercial fishermen would likely oppose
+such management zones, stressing that gear/area prohibitions could cause them
+economic harm; they believe that HMS fishery declines are the result of foreign
+fishing and environmental factors.
+
+Recreational and commercial fishing interests note that an issue at
+
+NMFS/NOAA Fisheries HMS Advisory Panel meetings, and one that continuously
+seems to frustrate U.S. efforts to rebuild HMS stocks, was the lack of a clear
+relationship between the MSFCMA and existing international treaties (e.g.,
+International Convention for the Conservation of Atlantic Tuna, the United Nations
+Convention of the Law of the Sea). Specifically, these groups question the
+practicality of domestic efforts to rebuild North Atlantic swordfish stocks in 10 years
+or less when the U.S. fisheries account for only 22% of fishing mortality.
+
+They suggest that it would be beneficial to study international fishing treaties
+
+and their relationship, precedence, and impact on and with the MSFCMA, the
+National Standards, and the precautionary approach. Moreover, they contend that a
+definitive domestic fishery policy is needed to decide on actions to be taken in the
+period between recognizing that an international fishery is overfished and
+implementing international management to rebuild those stocks.
+
+ Review of Fishery Management Plans. Section 304(a) of the MSFCMA
+
+establishes the process whereby the Secretary of Commerce and NMFS/NOAA
+Fisheries review and approve FMPs.
+
+Some fishery managers and commercial fishermen express concern about the
+
+accuracy and efficiency of the FMP approval process. They contend that frequent
+and lengthy delays in approving and implementing FMPs have damaged both the
+industry and fish stocks, and reflect poorly on the performance of NMFS/NOAA
+Fisheries. These groups may ask Congress to give regional councils final authority
+on FMP approval to streamline the process. Others counter that improving the
+review process is an administrative concern, and thus legislative action is not needed.
+Additionally, others suggest that it may be unconstitutional for regional councils,
+which are nongovernmental agencies, to have final decision-making authority about
+how best to use and manage the public’s marine fishery resources.
+
+Some federal fishery managers note that some of the delays in the approval
+
+process are the result of the regional council’s failure to produce FMPs that satisfy
+all of the legal requirements. Specifically, they note that the time between regional
+council action and final rule publication can be attributed to (1) assuring compliance
+with other applicable laws; (2) inadequately prepared supporting documentation from
+regional council staff, primarily related to compliance with other applicable laws; and
+(3) insufficient legal review staff in NOAA General Counsel. Another problem, in
+their view, is NOAA Fisheries’ review of FMPs and amendments separate from their
+review of the regulations that will implement these FMPs and amendments.
+
+ 
+ CRS-32
+
+As possible solutions, these managers suggest (1) requiring regional councils
+
+to take final action votes only on fully completed analyses (including the preferred
+alternative) and draft proposed rule notices; (2) closer linking of NOAA Fisheries’
+review of FMP and plan amendments with the review of implementing regulations;
+and (3) providing more funding for NOAA’s Office of the General Counsel.
+
+Some environmentalists contend that a strong NMFS/NOAA Fisheries review
+
+of FMPs is crucial to statutory compliance and to balancing regional interests with
+national priorities. They suggest that NMFS/NOAA Fisheries be authorized to
+modify an FMP to bring it into compliance with the MSFCMA if a regional council
+has not acted within a reasonable period of time to revise their FMP. They assert that
+providing regional councils multiple opportunities to comply with the MSFCMA
+delays implementation, and note that currently the Act imposes no deadline for
+regional council revisions of FMPs that were partially approved or rejected,
+furthering delays.
+
+Some suggest that FMPs should be exempt from many of the requirements of
+
+the National Environmental Policy Act (42 U.S.C. §§4321-4347), the Regulatory
+Flexibility Act (P.L. 96-354), and the Paperwork Reduction Act (44 U.S.C. §§3501-
+3520), which they believe delay the review process unnecessarily. Others, however,
+question such exemptions, expressing concern that the rights of fishermen might not
+be assured in such situations.
+
+ Management Based on Maximum Sustainable Yield. Currently, the
+
+MSFCMA requires FMPs to achieve the optimum yield (OY) from each fishery.
+Optimum yield is defined as MSY as “reduced” by economic, social, and ecological
+factors.80 Some fishery scientists suggest that Congress modify this definition. They
+argue that the concept of MSY is ineffectual for management and decision-making,
+because MSY is a long-term average yield, while the politics of fishery management
+tend to focus on much shorter-term results.
+
+As an alternative to MSY, some fishery scientists suggest that the MSFCMA
+
+incorporate the concept of an “ecosystem sustainable yield” (ESY). These scientists
+suggest that an ecosystem-based yield is preferable to attempting to simultaneously
+manage several species at their MSYs. At a minimum, Congress might acknowledge
+or recognize the multi-species tradeoffs in interacting food webs within marine and
+aquatic ecosystems.
+
+Some in the commercial fishing industry suggest that Congress should return
+
+the term optimum yield to its pre-1996 definition.81 This group believes that the
+current definition that “reduces” rather than “modifies” MSY hinders management,
+especially when contending with variations in stock size caused by environmental
+
+80 MSFCMA §3(28).
+
+81 The term optimum , with respect to yield from a fishery, means the amount of fish (A)
+which will provide the greatest overall benefit to the nation, with particular reference to food
+production and recreational opportunities; and (B) which is prescribed as such on the basis
+of the maximum sustainable yield from such fishery, as modified by any relevant economic,
+social, or ecological factor. MFCMA §3(21) (Aug. 1994).
+
+ 
+ CRS-33
+
+conditions. They state that, while MSY is difficult if not impossible to estimate,
+industry groups likely would support the use of long-term averages.
+
+Conversely, some environmental groups and fishery scientists support the 1996
+
+definition of OY, believing that linking OY to MSY ideally prevents overfishing.
+They assert that the prior definition allowed regional councils to set OY above MSY
+for short-term economic reasons, at the risk of overfishing. In their opinion, this
+approach led to “boom-and-bust” cycles and pulse fishing in many fisheries.
+Additionally, many environmental groups believe that linking OY to MSY would
+facilitate ecosystem-based management. However, they contend that many regional
+councils have not implemented the statutory requirements to reduce OY based on
+economic, social, and environmental factors (e.g., predator-prey relationships or the
+role of fish in the ecosystem). In their opinion, regional councils have set OY with
+little justification except for maximizing catch. This group may request that
+Congress require regional councils to consider ecosystem relationships in
+establishing optimum yield.
+
+Other fishery scientists and managers suggest that neither MSY nor ESY are
+
+practical concepts for optimum yield. They suggest that OY be defined in terms of
+the optimum level of fish removal that takes into account the long-term reproductive
+capacity of the stock, species composition of the catch, ecosystem concerns, catch
+capacity of the fleet, operational characteristics of the fishery, economic concerns,
+and how the fishery is managed.
+
+ Coordination and Oversight of State-Managed Fisheries. Section 306
+
+of the MSFCMA states that the Act neither extends nor diminishes the authority or
+jurisdiction of any state within its boundaries. Prior to 1976, states had management
+authority over all fisheries in waters adjacent to their states, and there was little or no
+federal jurisdiction over living marine resources in these waters. With enactment of
+the MSFCMA, marine fishery resources within the U.S. EEZ came under federal
+jurisdiction, while states retained jurisdiction of marine fishery resources from their
+coastline out to the U.S. EEZ, generally three nautical miles offshore. The
+MSFCMA attempts to balance state authority with federal conservation and
+management goals, principally through coordination activities and the advice of the
+Secretary and NMFS/NOAA Fisheries rather than direct oversight of state fishery
+management.
+
+Fishery managers suggest strengthening the relationship between federal and
+
+state fishery management. They assert that greater federal oversight is needed to
+improve decision-making by interstate fishery commissions. Currently, the practice
+of managing interstate fisheries is based on equivalency provisions , wherein states
+choose management measures they prefer, as long as the measures comply with
+federal conservation requirements. Fisheries in which management is coordinated
+by interstate commissions are often very diverse, and management approaches vary
+from state to state. Commissioners from one state often know little about another
+state’s fisheries. Fishery managers suggest that this hinders a state’s ability to make
+informed decisions about its conservation plans. The result, they allege, is continued
+overfishing and delays in stock rebuilding. Some interests suggest that Congress
+authorize an independent entity either to oversee or to directly manage interstate
+fisheries. One suggestion for strengthening coordination with states is to delegate
+
+ 
+ CRS-34
+
+FMP management authority to states, specifically, deleting the last sentence in
+§306(a)(3)(B), which states:
+
+For a fishery for which there was a fishery management plan in place on August
+1, 1996, that did not delegate management of the fishery to a State as of that date,
+the authority provided by this subparagraph applies only if the Council approves
+the delegation of management of the fishery to the State by a three-quarters
+majority vote of the voting members of the Council.
+
+ Decentralized Fishery Management. Some commercial fishing interests
+
+would oppose more centralized management at the federal level. They perceive the
+need for increasingly decentralized management at the local level (consistent with
+federal objectives), because they believe local individuals are more knowledgeable
+about specific environmental and economic conditions. In this view, fishing
+communities are readily able to adapt management to prevailing conditions and often
+are best suited to manage local fisheries. These interests may suggest that Congress
+amend the MSFCMA’s management authority to emphasize local management and
+decision-making.82 Such a dramatic change from the current management structure
+likely would require major amendment to the MSFCMA, and additional funding at
+the state and local levels.
+
+Some environmental organizations and other commercial and recreational
+
+fishing interests, while recognizing the need for local expertise, would oppose further
+decentralization of “the nation’s fisheries.” Generally, these groups oppose an
+increased emphasis on decentralized management, especially if it decreases the
+ability of those interested in fishery management, but unable to attend regional
+council meetings, to participate in the decision-making process. They are also
+concerned that management of fisheries could become a local issue, controlled and
+managed to maximize benefits to local interests, rather than benefits to the nation.
+Decentralized management, in their opinion, might put short-term local economic
+needs above long-term sustainability and productivity.
+
+ Co-Management and the Role of Native Americans. Previous
+
+reauthorizations of the MSFCMA added significant language to encourage
+exploration of the role of indigenous peoples in fishery management.
+
+Fishery scientists suggest that a greater emphasis be placed on incorporating
+
+traditional ecological knowledge into fishery management. These scientists suggest
+that Congress consider ways to incorporate the wisdom of indigenous cultures into
+contemporary management protocols. Examples of this approach include the
+Community Development Programs, which benefit Native Alaskans and Hawaiians
+and create a role for them in their respective regional councils. These interests
+suggest that Congress add language to the MSFCMA to ensure the longevity and
+success of these ventures.
+
+82 Additionally, some note that the jurisdiction over the 200-mile EEZ of some of the Pacific
+Island insular areas is disputed between federal and local governments. In some instances,
+federal jurisdiction spans the entire 200 miles, in contrast to other U.S. regions, where the
+first 3 miles of coastal water is generally under state jurisdiction. They contend that
+decentralization is the favored option in these disputed areas.
+
+ 
+ CRS-35
+
+In considering co-management of marine fisheries, Congress could look to co-
+
+management provisions in the Marine Mammal Protection Act (16 U.S.C. §1361) as
+a model. These provisions authorize the Secretaries of Commerce and the Interior
+to enter into cooperative agreements with Alaska Native organizations to conserve
+marine mammals and co-manage Native subsistence use. Through these cooperative
+agreements, Native organizations may receive grants to facilitate data collection and
+analysis, monitor subsistence harvests, participate in research projects, and develop
+co-management arrangements with federal and state agencies.
+
+ Aquaculture. Some in the commercial fishing industry assert that public
+
+demand for fishery products is driving the exploitation of marine resources,
+contending that sustainability is not just a local or coastal problem, but rather that
+national, long-term solutions are needed. They suggest encouraging the development
+of a variety of methods to provide the required quantities of fishery products to meet
+U.S. demands, especially aquaculture and hatcheries. For example, they point to the
+production of salmon in Maine and oysters in Long Island Sound, contending that
+their production is almost equal in value to that of the offshore groundfish, scallop,
+and lobster fisheries. Moreover, they assert that aquaculture operations require a very
+small fraction of the area devoted to “wild” fisheries.
+
+Another aspect is the development of offshore aquaculture, with concerns that
+
+the MFCMA may need to be amended to provide an appropriate framework for
+regional council consideration of these emerging fishery businesses in the EEZ. For
+more background on this issue, see CRS Report RS21914, Open Ocean Aquaculture ,
+by Rachel Borgatti and Eugene H. Buck.
+
+ Review of American Fisheries Act Provisions. Some commercial
+
+fishermen may seek a review of the provisions of the American Fisheries Act aimed
+at protecting fishermen who do not belong to a cooperative from having their access
+to harvestable fish preempted by those who do. They suggest that Congress might
+consider instructing regional councils to modify, expand, or limit the role of
+cooperatives depending upon the results of this review.
+
+ National Research Agenda. Some suggest that a “national research
+
+agenda” is needed to effectively coordinate and fund fishery research. They suggest
+that Congress consider authorizing a “Research Council” specifically focused on
+marine resource issues. Others suggest that the recent work of the Pew Oceans
+Commission and the U.S. Commission on Ocean Policy (see “Oceans Commissions”
+previously) may be adequate to stimulate more attention to these concerns.
+
+ Observer Status. Although not an MSFCMA issue, this concern is
+
+relevant to MSFCMA activities. The uncertain status of fishery observers under the
+Jones Act83 is reportedly causing insurance concerns for both observer contractors
+and fishing vessels, making it necessary for both parties to carry exorbitant insurance
+coverage. One approach may be to recognize observers such that they are covered
+by Workmen’s Compensation.
+
+83 This is the popular name for §27 of the Merchant Marine Act of 1920 (46 U.S.C. 883; 19
+C.F.R. 4.80 and 4.80b).
+
+ 
+ CRS-36
+
+ Experimental Fishing Permits. The MSFCMA currently does not allow
+
+research to develop or improve fishing gear, even when conducted by state or federal
+scientists, to be considered as scientific research, thus requiring that scientists
+complete a lengthy process to receive an experimental fishing permit. If the
+MSFCMA were amended to remove this exclusion, a simple Letter of
+Acknowledgment might be adequate to authorize gear research.
+
+ Socioeconomic Issues 
+
+Commercial and recreational fishing interests, environmental groups, and
+
+fishery scientists voiced concern regarding the need to clarify and/or modify how
+socioeconomic decisions affecting the fishing industry are made. These concerns
+range from narrow suggestions for improving how the fishing industry operates to
+broad commentary on the degree that socioeconomic factors should affect and direct
+MSFCMA policy.
+
+ Fishing Capacity Reduction. 84 Section 312(b)-(e) of the MSFCMA
+
+describes the use of fishing capacity reduction programs as a means to prevent
+overfishing, rebuild stocks, or improve conservation and management. The objective
+of capacity reduction programs, as stated in §312(b)(2), is “to obtain the maximum
+sustained reduction in fishing capacity at the least cost and in a minimum period of
+time.”
+
+How best to reduce fishing capacity, especially using a vessel buy-back
+
+program,85 is likely to be an issue during reauthorization. Some recreational and
+commercial fishermen as well as environmental groups want only buy-back programs
+that effectively and completely remove a vessel from all U.S. fisheries.86 Without
+this, these groups fear that individuals or groups of individuals could be compensated
+for exiting one overcapitalized fishery and then entering another fishery in which
+entry is not limited. This movement from one fishery to another displaces current
+participants and could result in other overcapitalized fisheries. Other fishermen favor
+the buy-back of only fishing permits, allowing vessel owners to continue using
+vessels they own for other (non-buy-back) fisheries.
+
+84 Excess fishing capacity decreases economic efficiency and often leads to overfishing
+and/or fishing derbies. Reductions in fleet capacity would help to reduce overfishing and
+greatly improve the ability to deal with uncertainty and unexpected events in fisheries.
+National Academy of Sciences, Sustaining Marine Fisheries (Washington, DC: 1999), p.
+119.
+
+85 Vessel buy-back is one means to reduce capacity in fisheries. Harvesters are paid to
+surrender their fishing permits and/or withdraw their vessels from fishing. See archived
+CRS Report 97-441 ENR, Commercial Fishing: Economic Aid and Capacity Reduction , by
+Andrew G. Read and Eugene H. Buck, available from the author.
+
+86 Environmental groups argue that, to effectively reduce fishing capacity, “bought-out”
+vessels should also be prevented from entering fisheries outside the United States. In their
+opinion, exporting domestic capacity leads to global fisheries depletion, which ultimately
+affects U.S. interests beyond the U.S. border.
+
+ 
+ CRS-37
+
+NMFS/NOAA Fisheries has been criticized for delays in developing
+
+guidelines for fishing capacity reduction programs. The proposed rule for fishing
+capacity reduction programs was published February 11, 1999 (64 Federal Register
+ 6854), but has not been finalized; a U.S. National Plan of Action for the Management
+of Fishing Capacity was released in August 2004.87 Critics suggest that these delays
+have resulted in the implementation of inconsistent fishing vessel and license
+buy-back programs, and that NMFS/NOAA Fisheries has a duty to provide an overall
+framework to guide capacity reduction programs. In contrast, other respondents note
+that (1) there is no statutory mandate requiring NMFS/NOAA Fisheries to produce
+capacity reduction guidelines, and that priority is given to producing statutorily
+mandated guidelines; (2) no buy-back programs have been implemented under
+MSFCMA §312, and therefore, delays could not have resulted in inconsistent
+implementation; and (3) the MSFCMA does not require national consistency and
+provides for a variety of mechanisms to fund capacity reduction programs.
+Additionally, some fishery scientists and environmental groups state that efforts
+should be made to reduce effort in fisheries before they reach overfished status. They
+suggest proactive reductions in capacity, aimed at preventing further declines, rather
+than waiting to react to stock collapse.
+
+Additional considerations for vessel buy-back programs include:
+
+! benefits may be minimal if only marginal operations (i.e., least-
+
+efficient operators or fishermen who fish only occasionally) are
+bought out, but the buyout cost would likely be lower;
+
+! individuals who hold fishing permits but do not currently use them
+
+(latent effort) may enter a fishery as others exit, offsetting reductions
+in capacity;
+
+! social and economic costs to the community as well as other
+
+requirements under the Regulatory Flexibility Act (P.L. 96-354) may
+outweigh the benefits to the resource;
+
+! compensation for boat owners may financially harm the captain or
+
+crew, who lose a source of income;
+
+! appropriate educational and vocational programs for the newly
+
+unemployed or bought-out maritime personnel may not be readily
+available;88
+
+! broader unemployment and other economic implications for the
+
+community (e.g., marine businesses that may suffer substantial
+income loss as the number of fishing vessels and processing plants
+declines) may become evident; and
+
+! buy-back programs may be criticized as ineffective if they are
+
+inefficient at reducing fishing capacity.
+
+NMFS/NOAA Fisheries notes that capacity reduction costs could be paid by
+
+harvesters who remain in a post-reduction fishery, or by taxpayers or others. In
+
+87 See [http://www.nmfs.noaa.gov/sfa/reg_svcs/npoa.capacity.8.4.04.pdf], visited Aug. 25,
+2004.
+
+88 Fishermen’s reasons for choosing fishing, including being on the water, independence,
+income potential, and other factors should be considered in proposing possible alternatives.
+
+ 
+ CRS-38
+
+essence, three funding options could come before Congress for capacity reduction
+programs: (1) government funding (taxpayers), (2) industry funding, or (3) joint
+government-industry funding.
+
+Some in the fishing industry strongly believe that, because government
+
+subsidy programs in the late 1970s and 1980s encouraged vessel construction (which
+lead to the overcapitalized fishery), the government should subsidize the buy-back.89
+That is, fishermen should not have to pay to remove capacity (effort) that the
+government was partly responsible for creating. Fishermen are divided as to whether
+buy-back programs should be industry- or government-funded. Fishermen who
+support an industry-funded program argue that more control would then have to be
+given to the industry regarding the procedures for a vessel-reduction program.
+Fishermen who support a government-funded program argue that it “adds insult to
+injury” to make fishermen pay for programs designed to “put them out of business.”
+
+Other respondents posit that, because harvesters reap benefits from improving
+
+the fishery and contributed to the depletion of some stocks, harvesters should bear
+the brunt of the cost for reducing fishing capacity. These observers contend that
+many of the vessels used to exploit U.S. marine resources were subsidized through
+the Capital Construction Fund. As such, the government should not be expected to
+pay for vessels a second time by paying owners not to fish.90 They assert that,
+because buy-back programs chiefly benefit those who remain in the fishery after
+capacity is reduced,91 post-reduction harvesters should fund the buy-back.
+
+Recreational fishing interests suggest that, in considering the capacity
+
+reduction issue, the law should distinguish between commercial and recreational
+fishing. They contend that recreational fishing is distinctly different from
+commercial fishing in that recreational fishing is tied to the experience of fishing
+rather than catching fish.92 Reducing fishing mortality and bycatch in recreational
+
+89 Some believe that this argument is counterintuitive, contending that the commercial
+fishing industry lobbied in favor of the subsidy programs, and that these subsidies were not
+foisted on an unwitting industry.
+
+90 Some argue that fishermen are largely responsible for overcapitalization, contending that,
+while NMFS/NOAA Fisheries did administer the Capital Construction program, the
+decisions to build or modify vessels were business decisions of the owners. These critics
+argue that blaming the government for overcapitalization is nonsense, particularly for
+overcapitalization in the New England fleet. New England’s groundfish fishery was
+declared a “conditional fishery” in the early 1980s, and vessels participating in this fishery
+were no longer eligible for the Fisheries Obligation Guarantee program authorized by Title
+XI of the Merchant Marine Act of 1936 (archived CRS Report 95-460 ENR, Summaries of
+Major Laws Implemented by the National Marine Fisheries Service , by Eugene H. Buck;
+available from the author). They also contend that fewer than 3% of New England’s
+groundfish vessels benefitted from this loan program.
+
+91 For example, harvesters in a post-reduction fishery will benefit from (1) increased catch,
+both as a percent of the total allowable catch and a larger total catch for their vessel, and (2)
+the likely increased value of their permit or license.
+
+92 However, subsistence/traditional and customary use fishermen are also currently reported
+
+(continued...)
+
+ 
+ CRS-39
+
+fisheries might be better achieved through public education and outreach initiatives,
+such as catch-and-release programs, use of hooks that ease release of fish and
+increase survivability (e.g., barbless, wide-gap, circle), and other ways of reducing
+harm and stress to fish (e.g., hook extractors and handling techniques that minimize
+harm by avoiding removal of the protective mucous layer and scales and by
+eliminating pressure on internal organs). Other respondents believe that owners of
+recreational fishing vessels (e.g., charter boats) are under enormous pressure to
+provide their customers with successful experiences and that recreational fishing does
+have a significant impact on sustainability in some fisheries. They contend that
+reductions in recreational capacity, funded by the recreational industry, also should
+be considered, at least in fisheries where recreational harvest is significant.
+
+ Individual Fishing Quotas. Individual fishing quotas are management
+
+tools that grant fishermen the privilege of catching a certain percentage of the total
+allowable catch. Section 303(d) of the MSFCMA established a moratorium, until
+October 1, 2000, on creating new individual fishing quota programs. Section 108(f)
+of the SFA, directed the National Academy of Sciences (NAS) to report on a national
+policy for individual fishing quota programs. The moratorium was extended an
+additional two years, to October 1, 2002, by P.L. 106-554 (114 Stat. 2763A - 238)
+after which it was allowed to expire with no further legislation enacted to establish
+national standards to guide new IFQ programs.93
+
+The NAS report94 recommended that the moratorium on individual fishing
+
+quota (IFQ) programs be lifted and suggested that Congress consider:
+
+! allowing fees for initial quota allocations, first sale of IFQs, and
+
+leasing of initial shares, as well as an annual tax on quota shares;
+
+! recognizing differences among regions and allowing regional
+
+councils flexibility in designing new (and adjusting existing) IFQ
+programs;
+
+! requiring regional councils to define excessive share and to limit
+
+accumulating quota shares; and
+
+! ensuring that funding is available to NMFS/NOAA Fisheries and the
+
+states for collecting relevant socioeconomic data.95
+
+In detailing its recommendations to Congress, the NAS committee asserted
+
+that most decisions about IFQs are appropriately made at the regional level. The
+
+92 (...continued)
+under the “recreational” category, for whom catch may be as or more important than the
+“experience of fishing.”
+
+93 National standards have been proposed in, for example, S. 1106 and H.R. 2621 in the 108th
+Congress.
+
+94 National Research Council , Sharing the Fish: Toward a National Policy on Individual
+Fishing Quotas (Washington, DC: National Academy Press, 1999), p. 189.
+
+95 In implementing IFQ programs, NAS notes that other factors include carefully developing
+management structure and initial allocation formula, involving stakeholders in program
+development, and including fishing communities in initial allocations.
+
+ 
+ CRS-40
+
+committee recommended to Congress that the design of any limited entry program
+in relation to concentration limits, transferability, and distribution of shares will
+depend on the objectives of each specific FMP, which underscores their
+recommendation to provide flexibility to regional councils in designing IFQ and
+other limited entry programs.
+
+Some commercial fishermen and fishery scientists are concerned that
+
+problems such as overcapitalization, waste, and bycatch can only be remedied
+through individual quota management. Meanwhile, recreational fishermen are likely
+to seek assurances that the recreational sector is considered in the development of
+IFQ programs, especially in initial quota allocation.
+
+Other commercial fishermen suggest that Congress authorize regional
+
+councils to use alternative approaches to IFQs, such as cooperative arrangements.96
+Some commercial fishermen have formed fish harvesting cooperatives under the
+American Fisheries Act (P.L. 105-277, beginning at 112 Stat. 2681-616) for pollock
+in the Bering Sea and Aleutian Islands area) in an effort to address overcapitalization
+and to avoid the wasteful race-for-fish.97 A fish harvesting cooperative represents a
+contractual agreement among eligible participants in a fishery to divide up the
+available harvest quota and to catch the fish in a tempered manner. While
+cooperative fishing is evidence of the benefits of individual quota management, there
+are significant differences between federally-mandated IFQ programs and private
+cooperative arrangements. As an alternative to IFQ programs, some commercial
+fishermen suggest that NMFS/NOAA Fisheries and regional councils be authorized
+to allocate quota to cooperatives.
+
+Some environmental organizations assert that enhanced conservation
+
+measures must be incorporated into IFQ programs as they are developed. These
+groups do not wholly accept the belief that IFQs will result in enhanced conservation,
+and seek stricter measures. They posit that IFQ programs should be held to higher
+standards for monitoring and accountability to ensure that conservation is enhanced.
+Additionally, some environmental and fishing groups have several concerns with IFQ
+programs and argue that (1) the federal government should not award the right to
+exploit a national resource without appropriate compensation to the public; (2)
+allocation of an IFQ may engender a property right, which may be difficult to reduce
+or rescind in the future without compensating the quota holder (i.e., subject to the
+constitutional “takings” clause); (3) quota consolidation may drive smaller operators
+out of business; (4) IFQs may reward “dirty” fishermen (those with high levels of
+bycatch and discards) because initial allocations are often based on catch history; and
+(5) IFQs may encourage fishermen to high-grade their catch, keeping only the most
+valuable fish.
+
+96 On the other hand, some fishery scientists suggests that Congress replace the list of
+vessels eligible to form cooperative arrangements under the American Fisheries Act
+(contained within P.L. 105-277) with a regular transferable license limitation or individual
+quota program.
+
+97 A 2002 report to Congress on the impacts of the American Fisheries Act is available from
+NOAA at [http://www.fakr.noaa.gov/npfmc/summary_reports/AFACongress202.pdf],
+visited Aug. 9, 2004.
+
+ 
+ CRS-41
+
+Several respondents note that the nature of the rights available through IFQ
+
+programs should be carefully specified. For instance, if IFQs were issued for an area,
+would that mean that IFQ holders would become eligible for compensation for the
+loss of their rights to harvest if the area was reduced by the establishment of an MPA
+or through major port developments and reclamations? Would Native American
+fishery claims need to be settled before issuing IFQs? Should IFQs be permanent
+rights or temporary privileges? Similar questions have arisen about permits and
+leases for federal grazing lands. The federal government has explicitly stated that
+private livestock grazing on federal lands is a privilege and not a right nor interest in
+property. Nonetheless, ranches with access to federal forage often sell for a higher
+price than they would without access to federal rangeland. The resulting value of the
+grazing preference is capitalized into the net worth of the ranch base property and is
+considered an asset by the rancher.98
+
+Other comments include the following: (1) IFQs could be a useful tool for
+
+managing certain recreational fisheries, such as Atlantic bluefin tuna, where a long
+history is available and the fishing constituency well known; (2) coastal communities
+should be given priority over corporate fishing and processing companies in initial
+allocation of quota shares; and (3) reductions in processing capacity may also be
+necessary to match reductions in fishing capacity; thus, fishing processors may seek
+a “processor quota” program and other means to allow paced reductions in
+processing capacity without a sudden or severe economic impact on local
+communities.99 Individual processor quotas were specifically provided in §801
+(Division B) of P.L. 108-199 as part of a Bering Sea and Aleutian Islands crab
+rationalization program. Whether to mandate the consideration or prohibition of
+processor quota in any IFQ program may be an issue during reauthorization, and the
+unfolding experience with processor quota in the Alaska crab fishery provides
+potentially useful background information.
+
+In another development related to IFQs, the North Pacific Regional Council
+
+amended its halibut and sablefish IFQ program to allow specific Gulf of Alaska
+communities to purchase halibut and sablefish quota share and lease them to
+community residents on an annual basis. The council designated 42 communities
+within the Gulf of Alaska who are eligible to participate in this program.100 Whether
+to specifically authorize the granting of IFQ shares to communities may be another
+issue for discussion during reauthorization.
+
+ Fees, Cost Recovery, and Economic Rent. Section 303(b)(1) of the
+
+MSFCMA establishes requirements for collecting fees for fishing permits. Section
+304(d) authorizes the Secretary of Commerce to establish fees. The level of fees
+charged may not exceed the administrative costs of issuing fishing permits, except
+
+98 CRS Report IB96006 (archived), Grazing Fees and Rangeland Management , by Betsy
+Cody and Pamela Baldwin, p. 8.
+
+99 Alternatively, in some cases, imports may be available to cover any reductions in locally
+available fish.
+
+100 For more information, see 69 Federal Register 23681-23694, Apr. 30, 2004.
+
+ 
+ CRS-42
+
+in individual quota and community development quota (CDQ) fisheries, where fees
+recover management and enforcement costs.
+
+The MSFCMA currently allows fees to be charged for (1) foreign fishing
+
+permits and NMFS/NOAA Fisheries observer costs; (2) administrative costs of
+issuing fishing permits; (3) enforcement and management costs in IFQ and CDQ
+fisheries; (4) administrative costs for limited access system registry; (5) fishery
+reduction program assessments (including vessel/permit buy-backs); and (6) the
+North Pacific observer program.101 Other than for fisheries managed under IFQs and
+CDQs, the MSFCMA does not allow for management and enforcement cost
+recovery.
+
+Cost recovery could be an important issue during reauthorization. The overall
+
+performance of a fishery is often influenced by how fishery management is financed.
+The typical practice — where 100% of management and enforcement costs are borne
+by the General Treasury102 — is alleged to inefficiently use resources for research,
+decision-making, and enforcement. When resource users do not share some of the
+cost for resource management, they are allegedly less attentive to the need for
+efficiency. The cost of this inefficient use accrues to the management agency and
+increases the overall cost of managing the resource. Fishery economists suggest that
+such inefficiencies are reduced when users of natural resources, especially
+commercial users, bear some of the costs for managing these resources. Thus, they
+suggest that Congress consider user charges to recover a significant portion of fishery
+management and enforcement costs.
+
+Some fishery managers assert that the cost recovery authority currently in the
+
+MSFCMA (§304(d); 16 U.S.C. §1854(d)) for IFQ and CDQ systems is too
+
+101 Some commercial fishermen note that the North Pacific Regional Council has authority
+for a fee-based observer program, but has not yet implemented the program. The authority
+for a fee-based program includes a cap on observer fees of 2% of the unprocessed harvest
+value. Under the current “pay as you go” system, many smaller vessels are paying in excess
+of 2% of revenues, while other larger operations pay a fraction of that amount. This
+disparity undermines support for the observer program. They suggest that NMFS/NOAA
+Fisheries develop the best observer program they can within the budget constraints of a 2%
+fee, equitably distributed over the whole fleet. This might be a model for how user fees
+could function, but until this program is implemented and demonstrates success, authority
+for further fee-based programs will meet significant resistance from commercial fishermen.
+
+102 Government expenditures on U.S. fisheries currently run about $1 billion a year. These
+government expenditures are directed at an industry generating about $3.5 billion in
+ex-vessel revenue. That is, government expenditures are roughly 30% of landed value. At
+the federal level, the proportion of expenditures to landed value is 50%. The landings value
+of fish caught in federal waters (i.e., from 3 to 200 miles) averages $1.8 billion in recent
+years while the amount of federal government expenditures is approximately $0.9 billion.
+See P. Andersen, K. J. G. Sutinen and K. Cochran, Paying for Fishery Management:
+Economic Implications of Alternative Methods of Financing Management , presented to the
+IXth Conference of the International Institute of Fisheries Economics and Trade (Tromso,
+Norway: July 8-11, 1998; hereafter “Economic Implications”). By inference, these
+estimates imply that ex-vessel revenues from state waters are about $1.7 billion per year,
+while state government expenditures are roughly $100 million — approximately 7% of
+landed value.
+
+ 
+ CRS-43
+
+restrictive. They contend that statutory specification of when, where, and how fees
+are collected introduces administrative inefficiencies that reduce the benefit of the
+fees, and actually prevent consolidation of fee collection with existing state fees.
+Further, any specific limitation of the fees to a percent of ex-vessel value and the
+specific deductions and exceptions, in their opinion, prevent NMFS/NOAA Fisheries
+from recovering reasonable management and enforcement costs. These managers
+suggest that the language at §304(d) could be amended to allow NMFS/NOAA
+Fisheries more flexibility in working with the industry to develop a simple, low-cost,
+effective fee collection system.
+
+Some fishery scientists suggest that, beyond recovering the costs of
+
+management and enforcement, the public should receive a share of the economic rent
+garnered from private use of a public resource. These advocates maintain that
+Congress should consider imposing fees on quota or harvest to provide a source of
+revenue and compensate the public. They believe that establishing a fee system for
+harvesting fish would put fisheries on par with other public resources (e.g., timber
+and energy resources).103 These funds could contribute to recovering management
+and enforcement costs (as discussed above). These scientists note that rent
+extraction, beyond cost recovery, could support fishery research or assist fishing
+communities or fishermen displaced by IFQ programs.104 Those supporting this
+approach explain that, in an IFQ fishery, compensation could occur through capturing
+a portion of the “windfall gains” generated from the initial transfer of the public
+resource into private hands (i.e., the initial allocation of fishing quota shares).105
+
+Some commercial fishermen claim that extracting economic rent from
+
+fisheries managed under open access will impoverish fishermen. Because there are
+no incentives to constrain effort, open-access fisheries tend toward
+overcapitalization, which dissipates economic rent and, on average, reduces profit.
+They suggest that economic rent should be extracted only from fisheries where access
+is limited and harvesters have a secure right to a certain quantity of the total
+allowable catch (e.g., individual fishing quota programs).
+
+Additional comments about fees, cost recovery and economic rent include:
+
+! NMFS/NOAA Fisheries has a history of using funds collected from
+
+a specific region or a specific purpose for general expenditures.
+Instead, fees, cost recovery, and economic rent should be used in the
+region that generates the funds, specifically, for data collection,
+management, and enforcement.106
+
+103 National Research Council, Sharing the Fish: Toward a National Policy on Individual
+Fishing Quotas (Washington, DC: 1999), p. 208 (Hereafter “Sharing the Fish”).
+
+104 Sharing the Fish, p. 209.
+
+105 Sharing the Fish, p. 207.
+
+106 Others perceive a danger in tying fees generated by a region to expenses in that region
+as this approach could create incentives for managers to keep catch limits artificially or
+inappropriately high to protect budgets. They feel it would be much better to assure that
+
+(continued...)
+
+ 
+ CRS-44
+
+! User fees should be tied to co-management of the resource. If a user
+
+pays, the user should have a voice in how the money is used and
+how the resource is managed.107
+
+! By tying user fees to research, those paying may have a stronger
+
+voice in how research is conducted, potentially reducing the
+independence and quality of the science.
+
+! Quota sales typically underestimate the long-term value of resource
+
+rights and only a fraction of the discounted value of expected future
+economic profit is realized by the first transaction.
+
+! Congress might consider fees and rent capture in discussions about
+
+IFQ program standards.
+
+ Fishery Subsidies. Section 312 of the Sustainable Fisheries Act of 1996
+
+(P.L. 104-297, §312(b)(note)) directed the Secretary of Commerce to establish a task
+force to study and report to Congress on the role of the federal government in
+subsidizing the expansion and contraction of fishing capacity. The report of this
+Federal Investment Task Force was published in July 1999.108 The Task Force
+concluded that any empirical analysis of capacity and capacity utilization needed to
+consider the fishing activity of recreational anglers and recommended that specific
+modifications be made to the Capital Construction Fund, Fisheries Obligation
+Guarantee, and other assistance programs.
+
+Environmental organizations active in the federal investment study note that
+
+fishery subsidies have emerged as a significant fishery management issue. As
+evidence, they note that policymakers are increasingly recognizing the direct
+relationship between subsidies, fleet overcapacity, and overfishing, as well as their
+effects on international trade in fish products. For example, in February 1999, the
+United Nations Food and Agriculture Organization (FAO) adopted the International
+Plan of Action (IPOA) for the Management of Fishing Capacity, which recognizes
+fishery subsidies as an important driver of overcapacity.109 Moreover, the need to
+address the problem of fishery subsidies has been recognized by the World Bank, the
+Asian Development Bank, the U.N. Commission on Sustainable Development, the
+World Trade Organization (WTO), the Organization for Economic Cooperation and
+Development (OECD), and the Asia-Pacific Economic Cooperation forum (APEC).
+
+106 (...continued)
+science and management are objective by not connecting budgets with harvest levels. In
+addition, a low-revenue fishery may require significant research, perhaps because it affects
+other target fisheries. Such a situation could lead to irrevocable closures if funds for
+monitoring required to open a fishery were lacking.
+
+107 Collaborative management options for local research and management involving industry
+cooperation (e.g., stock assessment surveys conducted aboard commercial fishing vessels)
+might help shift some costs to industry, as well as engage those dependent upon
+management decisions, without impinging upon the objectivity of the science.
+
+108 See [http://www.nmfs.noaa.gov/sfa/ITF.html], visited Aug. 9, 2004.
+
+109 U.N. Food and Agriculture Organization, Fisheries Department, The International Plan
+of Action for the Management of Fishing Capacity (Rome, Italy, Feb. 1999). This document
+is available at [http://www.fao.org/DOCREP/006/X3170E/x3170e04.htm], visited Aug. 10,
+2004.
+
+ 
+ CRS-45
+
+In the months and years ahead, the management of fishery subsidies will
+
+likely be the subject of continuing technical and diplomatic discussions within FAO,
+OECD, WTO, and APEC. Environmental groups note that the United States has
+played a leading role in bringing attention to the fishery subsidies issue, and add that
+fishery subsidies in the United States are far smaller than in many other major fishing
+nations. In their opinion, Congress will likely be called upon to act on this issue,
+through U.S. domestic policy and international efforts to reduce fishery subsidies.
+
+In addition, some fishery scientists suggest that a subtle relationship exists
+
+between subsidies and the collection of fees (as discussed below). By not recovering
+the costs of management and enforcement, the United States, in their opinion, is
+effectively subsidizing fishing operations. In essence, they define subsidy as a sale
+or transaction for a good or service by a government at less than the fair market price
+(where fair market is defined as a willing buyer and willing seller). Thus, they
+contend that, because the nation’s fishery resources (managed by the federal
+government) are more easily available than if a private owner controlled access, the
+fishery “market” is by definition not “fair.” Hence, a subsidy exists. Moreover,
+others note that the Uruguay Round of WTO negotiations defined subsidies as having
+three basic elements: (1) a financial contribution, (2) by a government or any public
+body within the territory of a Member, (3) which confers a benefit.
+
+ Fishing Communities. Section 3(16) of the MSFCMA (16 U.S.C.
+
+§1802(16)) defines fishing community as “a community which is substantially
+dependent on or substantially engaged in the harvest or processing of fishery
+resources to meet social and economic needs, and includes fishing vessel owners,
+operators, and crew and United States fish processors that are based in such
+community.”
+
+NOAA has further interpreted fishing community to mean “a social or
+
+economic group whose members reside in a specific location and share a common
+dependency on commercial, recreational, or subsistence fishing or on directly related
+fisheries-dependent services and industries (for example, boatyards, ice suppliers,
+tackle shops).”110 NOAA’s expanded interpretation of fishing community recognizes
+that more businesses depend on fishing activities than just fishing vessels, processors,
+and wholesale plants. For instance, businesses that sell supplies and gear and those
+devoted to marine services such as financial settlements and bookkeeping often
+depend totally on fishing activities and could be considered part of the fishing
+community. This interpretation recognizes that every change in mesh-size
+regulations changes the inventory value in ship supply stores; every reduction in the
+number of vessels reduces bookkeeping services. Such an interpretation recognizes
+that the fishing community extends beyond actual fishing activities and the
+processing of product, and that social and economic problems associated with the
+decrease in support services can seriously degrade the quality of life and economic
+health of communities.
+
+Some commercial fishermen are concerned that the geographically-based
+
+interpretation of fishing community could harm fishing communities that are based
+
+110 50 C.F.R. §600.345(b)(3).
+
+ 
+ CRS-46
+
+on shared interest rather than a shared place.111 Congress may be asked to modify
+this definition to clarify how this term should be used in social and economic
+analyses of fishery management actions. Specifically, commercial fishermen and
+fishery scientists may suggest that Congress include “virtual communities”112 in the
+definition of fishing communities.113 Conversely, recognition of virtual communities
+may be opposed by rural communities, which are likely to favor a geographic
+definition. These groups, tied to a place and often with limited economic
+opportunities, may feel threatened if virtual communities displace what they perceive
+to be their traditional fisheries.114
+
+ Small Boat Fleets and Family Fishermen. Although small boat fleets
+
+and family fishermen are not given general consideration in the MSFCMA, these
+individuals are mentioned specifically in §303(d)(4)(A)(i) that governs aid in
+financing the acquisition of individual fishing quota.
+
+The theme of “small” versus “large” fishing operations, whether vessels or
+
+service providers, is a very important issue in fishing communities and the industry,
+where many small operators perceive MSFCMA bias toward consolidation and large
+operations. To address these concerns, some commercial fishing interests suggest
+amending the MSFCMA to incorporate specific provisions to foster and support
+small-boat and family fishing operations. These interests are alleged to have a strong
+commitment to resource sustainability and possess culturally derived desires to pass
+along “their” fishery to future generations. One proposal to provide additional
+support for small boat and family fisherman is to restrict U.S. imports to fish
+harvested by fishing fleets that use conservation measures comparable to those
+required in the United States. However, some fishery scientists note that providing
+additional support to small fishermen by restricting access to U.S. markets might
+violate World Trade Organization obligations and international law, and violate U.S.
+commitment to remove subsidies that support overcapitalization.
+
+ Transfer Pricing. Commercial fishing interests are concerned about
+
+transfer pricing, especially in North Pacific fisheries. This is not currently addressed
+in the MSFCMA. Transfer price is the price charged by one company to a related
+company for allocating income and expenses among themselves. These “intra-firm
+transfers” are covered under the Internal Revenue tax code at 26 U.S.C. §482. Some
+U.S. fishing companies allegedly are not properly reflecting income attributable to
+
+111 For example, fishing cooperatives in the Bering Sea walleye pollock fishery and in the
+Pacific whiting fishery may be considered communities of individuals who share an interest
+in these fisheries, but are drawn from a diverse geographic base. In addition, not all
+services, or even fishermen, for a given port community reside in that port.
+
+112 National Academy of Sciences, Sustaining Marine Fisheries (Washington, DC: 1999),
+p. 97.
+
+113 However, virtual communities may be difficult to marry to economic analysis,
+particularly when indirect impacts are to be analyzed. For limited access systems, 16 U.S.C.
+§1853(b)(6) does allow virtual communities to be assessed in conjunction with place-based
+communities, creating a more complete view.
+
+114 However, potential tools to protect place-based communities are being implemented (e.g.,
+regionalization in the Bering Sea and Aleutian Islands crab rationalization program).
+
+ 
+ CRS-47
+
+their operations within the United States, while some foreign parent companies may
+be using pricing strategies to avoid higher U.S. taxes. In addressing “abusive”
+transfer pricing, Congress could consider amending the MSFCMA to require full
+disclosure of all financial documents and transfer pricing criteria to U.S. authorities.
+
+Others believe that this issue is not germane to reauthorizing the MSFCMA,
+
+and suggest that this “tax and trade” issue is more appropriate to the jurisdiction of
+other congressional committees — such as House Ways and Means and Senate
+Finance.
+
+ The Definition of Recreational Fishing. Some note that clarifying the
+
+definition of recreational fishing would be beneficial to fishery management. They
+suggest that Congress define recreational fishing as any fishery for which catch is not
+sold. In their opinion, this small change would clarify the distinction between
+commercial and recreational fisheries. Others, however, caution that defining
+recreational and subsistence fishermen who sell small amounts of catch to cover trip
+expenses as “commercial” might result in substantial administrative and enforcement
+expenses to deal with the potentially large number of individuals who sell small
+quantities of product.
+
+ The Private Cost of Resource Management. The MSFCMA requires
+
+that overfished stocks be restored within 10 years. Some assert that 10 years is a long
+time for an individual or company, dependent on a fishery, to endure substantially
+reduced earnings with no guarantee of recovering those losses and considerable
+uncertainty about their potential future earnings. A viable consideration, in their
+opinion, is the promotion of certainty for those vessel owners, operators, and crew
+who forgo earnings today for potential gains tomorrow. They note that current
+analyses examine the potential long-term yields and earnings streams, but that these
+analyses rarely incorporate risk assessment.
+
+ Federal Assistance to Fishermen. Some environmental groups believe
+
+that many commercial fishermen share their interest in rebuilding overfished stocks
+and promoting long-term resource sustainability. To rebuild fish stocks, these groups
+would like Congress to consider significant reductions in fishing effort, coupled with
+federal assistance for fishermen to relieve the economic burden of reduced fishing
+opportunities.
+
+ Fishing Vessel and Crew Safety. Some commercial fishermen contend
+
+that it is imperative that fishery management explicitly considers whether or not
+regulations will compel fishing captains and crew to work under unsafe conditions.
+Although one of the national standards (16 U.S.C. 1851(a)(10)) already requires that
+conservation and management measures “promote the safety of human life at sea,”
+these fishermen suggest that additional congressional action may be necessary to
+more specifically address this issue.
+
+ Adequacy of Appropriations 
+
+An issue that NMFS/NOAA Fisheries might raise during reauthorization
+
+discussions is that, in an era of reduced federal appropriations and shifting federal
+priorities, its responsibilities and duties continue to expand. Specifically,
+
+ 
+ CRS-48
+
+implementing the provisions of the Sustainable Fisheries Act is a major undertaking,
+requiring the coordination of NMFS/NOAA Fisheries headquarters and regional
+offices, the eight regional fishery management councils, and state agencies.
+NMFS/NOAA Fisheries may claim that delays in implementation were directly tied
+to budgetary constraints. Congress might consider a number of options to address
+these concerns. As noted previously, fees or other forms of rent extraction could be
+used to fund at least some management and enforcement. Congress might also
+consider increasing appropriations to NMFS/NOAA Fisheries or including specific
+instructions about how funds are to be used.
+
+For FY2005, the National Oceanic and Atmospheric Administration
+
+requested about $735 million for fisheries. The U.S. Coast Guard is estimated to
+spend approximately $400 million on fishery law enforcement (mostly for domestic
+fishery regulations), and these expenditures are projected to grow rapidly.
+Expenditures on other federal fishery programs are conservatively estimated to be in
+the neighborhood of $50 million per year. While these other programs are not fishery
+management per se, they do indirectly affect management efforts (e.g., fishing vessel
+compensation, fishing vessel contingency fund, trade promotion). Coastal states are
+estimated to spend between $100 to $150 million annually on fishery management.115
+
+ Congressional Outlook 
+
+Interested constituencies feel that Congress has been generally very
+
+supportive of measures to conserve and manage living marine resources, including
+specifically the Magnuson-Stevens Fishery Conservation and Management Act.
+While the history of the Act includes court challenges to agency interpretation of
+congressional intent, these groups believe that Congress has been generally
+understanding of the difficulties in balancing resource conservation, sustainable
+resource use, and protection of the marine environment. The issues discussed in this
+report set before Congress a varied array of concerns, with little clear focus as to
+which will gain prominence in the reauthorization debate. Recent public sentiment,
+always a strong factor in fishery conservation and management issues, has focused
+on concerns for protecting fish habitat, restoring depleted fish stocks, minimizing
+bycatch and bycatch mortality, and reducing fishing capacity. Specific interests of
+environmental protection groups, Native Americans, and commercial and
+recreational fishing industries may call attention to additional issues. Although
+congressional oversight in the early stages of the reauthorization process focused
+attention on numerous issues, no issues appear to demand immediate action. Since
+the requirements of the MSFCMA did not expire when the authorization of
+appropriations was not extended beyond FY1999, the reauthorization process could
+be delayed until sufficient congressional will is mustered to deal with the various
+issues. It is possible that, in response to the recent recommendations by the Pew
+Oceans Commission and the U.S. Commission on Ocean Policy, Congress might
+address MSFCMA reauthorization in the context of broader ocean policy issues.
+
+115 Economic Implications.
+
+ 
+ CRS-49
+
+ Appendix: 
+
+ Oceans Commissions’ Recommendations 
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Science: 
+
+Strengthened role
+
+Recommendation 19-1. Congress should amend
+
+Develop specific, measurable criteria and
+
+the Magnuson-Stevens Fishery Conservation and
+
+indicators for the health and integrity of marine
+
+Management Act and related statutes to require
+
+ecosystems by conducting a Committee of
+
+Regional Fishery Management Councils
+
+Scientists process similar to that followed under
+
+(RFMCs) and interstate fisheries commissions to
+
+the National Forest Management Act.
+
+rely on their Scientific and Statistical Committees
+(SSCs), incorporating SSC findings and advice
+into the decision-making process. In keeping
+with this stronger role, SSC members should
+meet more stringent scientific and conflict of
+interest requirements, and receive compensation.
+
+Management and
+
+Recommendation 19-2. Scientific and Statistical
+
+Conservation decisions should be based upon
+
+allocation
+
+Committees (SSCs) should be required to supply
+
+recommendations from regional science and
+
+decisions
+
+Regional Fishery Management Councils
+
+technical teams — composed of federal, state,
+
+(RFMCs) with the scientific information
+
+and academic scientists. Regional science groups
+
+necessary to make fishery management decisions. 
+
+should recommend ecologically safe catch limits
+
+Such information could include reports on stock
+
+and other conservation criteria for an FMP,
+
+status and health, socioeconomic impacts of
+
+informed by — and consistent with — goals,
+
+management measures, sustainability of fishing
+
+indicators, and targets of a regional ecosystem
+
+practices, and habitat status. In particular, the
+
+plan.
+
+SSCs should determine allowable biological
+catch (ABC) based on the best scientific
+information available to them.
+
+New fisheries
+
+No similar recommendation.
+
+Enact an emerging fisheries policy. The purpose
+of the policy should be to allow industry
+development of new fisheries in a manner that
+promotes sound scientific management and long-
+term conservation of the resources being
+developed and the relevant ecosystem.
+
+Independent
+
+Recommendation 19-4. NMFS/NOAA Fisheries,
+
+Create a mechanism that regularly provides
+
+review
+
+working with the Regional Fishery Management
+
+independent scientific oversight. Establish a
+
+Councils and the interstate fisheries commissions,
+
+Marine Fisheries Oversight Commission along
+
+should develop a process for independent review
+
+the lines of the Marine Mammal Commission, or
+
+of the scientific information generated by the
+
+require periodic scientific audits by the National
+
+Scientific and Statistical Committees in all
+
+Academy of Sciences, or both. The work of the
+
+regions.
+
+regional science groups should be regularly
+subject to independent peer review.
+
+International
+
+Recommendation 19-24. The U.S. Department
+
+No similar recommendation.
+
+focus
+
+of State, working with the National Oceanic and
+Atmospheric Administration, should review and
+update regional and bilateral fishery agreements
+to which the United States is a party, to ensure
+full incorporation of the latest science and
+harmonize those agreements with the Fish Stocks
+Agreement.
+
+ 
+ CRS-50
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Harvests: 
+
+Exploitation
+
+Recommendation 19-3. Each Regional Fishery
+
+Core conservation decisions should be made by
+
+limits
+
+Management Council should be required to set
+
+the NMFS/NOAA Fisheries, or a revamped
+
+harvest limits at or below the allowable biological
+
+fishery service within a new independent oceans
+
+catch (ABC) determined by its Scientific and
+
+agency. These decisions should originate at the
+
+Statistical Committee. The regional councils
+
+regional offices with oversight by the national
+
+should begin immediately to follow this practice,
+
+headquarters office. At a minimum, these
+
+which need to be codified at the next opportunity
+
+decisions include setting ecologically safe levels
+
+in amendments to the Magnuson — Stevens
+
+of exploitation (total catch and bycatch limits);
+
+Fishery Conservation and Management Act.
+
+specific habitat and area protections; and specific
+protected species requirements (threatened and
+endangered marine mammals, sea turtles,
+seabirds, and fish). Implement precautionary
+total allowable catches (TAC), or alternative
+fishing privileges that demonstrably control
+exploitation within ecologically safe limits. 
+Allocate privileges in ways that properly align
+incentives, allow for the orderly operation of a
+fishery (e.g., individual or community fishing
+quota programs), and maintain flexibility,
+resilience, and adaptability within the industry
+and fishing communities.
+
+Deadline for ABC
+
+Recommendation 19-5. Each Regional Fishery
+
+No similar recommendation.
+
+determination
+
+Management Council should set a deadline for its
+Scientific and Statistical Committee (SSC) to
+determine allowable biological catch (ABC). If
+the SSC does not meet that deadline, the
+NMFS/NOAA Fisheries Regional Science
+Director should set the allowable biological catch
+for that fishery.
+
+Separation of
+
+No similar recommendation.
+
+Separate conservation and allocation decisions. 
+
+conservation and
+
+Create a clear separation between conservation
+
+allocation
+
+and allocation decisions in the fishery-
+management planning process. The regional
+fishery management councils should make
+allocation decisions. Allow individual fisheries
+to develop their own allocation plans pursuant to
+approval and coordination of plans by the
+regional councils. Allow regional councils to
+improve upon or set higher conservation
+standards than those established in federal law or
+by NMFS/NOAA Fisheries, but ensure that
+established conservation standards are not
+undercut in the allocation process. 
+NMFS/NOAA Fisheries should retain authority
+to review a regional council’s allocation
+decisions for consistency with conservation. 
+NMFS/NOAA Fisheries should retain
+responsibility for implementation after the
+conservation and allocation planning processes
+are completed.
+
+ 
+ CRS-51
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Research: 
+
+Regional council
+
+Recommendation 19-7. The Regional Fishery
+
+No similar recommendation.
+
+needs to
+
+Management Councils and their Scientific and
+
+NMFS/NOAA
+
+Statistical Committees should develop an annual,
+
+Fisheries
+
+prioritized list of management information needs
+and provide it to NMFS/NOAA Fisheries. 
+NOAA Fisheries should incorporate these needs
+to the maximum extent possible in designing its
+research, analysis, and data collection programs.
+
+Collaborative
+
+Recommendation 19-9. Congress should
+
+No similar recommendation.
+
+projects
+
+increase support for an expanded, regionally
+based cooperative research program in the
+National Oceanic and Atmospheric
+Administration (NOAA) that coordinates and
+funds collaborative projects among scientists and
+commercial and recreational fishermen. NOAA
+should develop a process for external evaluation
+and ranking of all cooperative research proposals
+to ensure the most worthwhile projects are
+funded, the most capable performers are
+undertaking the research, and the information
+produced is both scientifically credible and useful
+to managers.
+
+Toxics
+
+No similar recommendation.
+
+Sufficient resources should be devoted to
+studying the effects of toxic substances in the
+marine environment. Needed research includes
+(a) studies on mercury in fish and other species
+that are located near offshore oil rigs and in other
+areas where species may be affected by drilling
+muds and contaminated sediments.
+
+Gear modification
+
+No similar recommendation.
+
+Fund a gear-modification research program to
+redesign mobile bottom gear to reduce habitat
+damage in fisheries that cannot be viably fished
+without such gear.
+
+Funding
+
+No similar recommendation.
+
+Funds received from allocating fishing privileges
+beyond cost recovery should go toward improved
+fishery research, management, and enforcement.
+
+ Saltwater 
+
+Recommendation 19-8. NMFS/NOAA Fisheries,
+
+No similar recommendation.
+
+ angling license 
+
+working with states and interstate fisheries
+commissions, should require all saltwater anglers
+to purchase licenses to improve in-season data
+collection on recreational fishing. Priority should
+be given to fisheries in which recreational fishing
+is responsible for a large part of the catch, or in
+which recreational fishermen regularly exceed
+their allocated quota.
+
+ Citizen suits 
+
+No similar recommendation.
+
+Allow citizen suits. Include a citizen suit
+provision in fishery conservation and
+management laws like those in most other major
+federal environmental statutes. Citizens must be
+allowed to hold fishery managers who violate the
+law accountable, or to force reluctant or negligent
+fishery management agencies to enforce the law.
+
+ 
+ CRS-52
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Planning
+process: 
+
+Timely
+
+Recommendation 19-6. Once allowable
+
+No similar recommendation.
+
+biological catch is determined, whether by the
+Scientific and Statistical Committee or the
+NMFS/NOAA Fisheries Regional Science
+Director, the Regional Fishery Management
+Council should propose an FMP in time for
+adequate review and approval by NOAA
+Fisheries.
+
+Suspend fishing if
+
+Recommendation 19-6. If the plan is not
+
+If a fishery or regional fishery management
+
+not complete
+
+presented in a timely fashion, all fishing on that
+
+council fails to revise or update an
+
+stock should be suspended until NOAA Fisheries
+
+implementation and allocation plan when
+
+can review the adequacy of the management plan.
+
+required, a default plan should be imposed by the
+federal fishery agency.
+
+ Consistent state 
+
+Recommendation 19-10. Congress should
+
+No similar recommendation.
+
+ fishery 
+
+develop new statutory authority, similar to the
+
+ management 
+
+Atlantic Coastal Fisheries Cooperative
+
+ commission 
+
+Management Act, to support and empower the
+
+ authority 
+
+Gulf States and Pacific States Fisheries
+Management Commissions. All interstate
+management plans should adhere to the national
+standards in the Magnuson — Stevens Fishery
+Conservation and Management Act and the
+federal guidelines implementing these standards. 
+States should participate in guideline
+development to ensure they are relevant to
+interstate plans.
+
+ Transboundary 
+
+Recommendation 19-11. When a fish stock
+
+No similar recommendation.
+
+ stocks 
+
+crosses administrative boundaries, Congress
+should clearly assign fishery management
+jurisdiction and authority. For each FMP, a state,
+Regional Fishery Management Council (RFMC),
+interstate fisheries commission, or the National
+Oceanic and Atmospheric Administration
+(NOAA) should be established as the lead
+authority. That designation should be based
+primarily on the proportion of catch associated
+with each management authority. However, once
+designated, management authority should not
+shift based on annual changes in landings
+
+ New regional 
+
+Recommendation 19-14. NMFS/NOAA
+
+No similar recommendation.
+
+ council member 
+
+Fisheries should require all newly appointed
+
+ training 
+
+Regional Fishery Management Council (RFMC)
+members to complete a training course within six
+months of their appointment. NOAA Fisheries
+should contract with an external organization to
+develop and implement this training course and
+Congress should provide adequate funding. 
+Members who have not completed the training
+may participate in RFMC meetings, but may not
+vote.
+
+ 
+ CRS-53
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Dedicated access
+privileges: 
+
+Authorize
+
+Recommendation 19-15. Congress should amend
+
+Allocate fishing privileges to align incentives,
+
+the Magnuson-Stevens Fishery Conservation and
+
+allow for the orderly operation of a fishery, and
+
+Management Act to affirm that fishery managers
+
+maintain flexibility, resilience, and adaptability
+
+are authorized to institute dedicated access
+
+within the industry and fishing communities. 
+
+privileges. Every federal, interstate, and state
+
+Individual or community fishing quotas (IQs or
+
+fishery management entity should consider the
+
+CQs), if properly monitored and enforced, appear
+
+potential benefits of adopting such programs.
+
+to be among the more effective allocation
+mechanisms.
+
+Guidelines and
+
+Recommendation 19-15. Congress should direct
+
+ For instances where IQs or CQs are chosen to
+
+standards
+
+NMFS/NOAA Fisheries to issue national
+
+allocate direct catch limits, they should be
+
+guidelines for dedicated access privileges that
+
+implemented according to the following three
+
+allow for regional flexibility in implementation.
+
+national standards: (1) Periodically allocate quota
+using a combination of catch history records, bids
+in the form of offered royalty payments on the
+catch, and conservation commitments offered by
+the bidder. Partition quota into different
+categories for different types of fishing
+operations before being auctioned — some for
+large vessels and corporations, some for owner
+operators and smaller vessels, some for new
+entrants, etc. Quota should also not be
+transferable among these different categories. (2)
+Regularly review and evaluate quota programs to
+maintain flexibility in anticipation of changes
+within the industry and fishing communities
+resulting from the transition to adaptive,
+ecosystem-based management; assess the
+performance of the program to ensure it continues
+to meet the objectives of the national policy; and
+revise the program if it fails to meet clear
+conservation performance standards, timetables,
+and other evaluation criteria. (3) Prevent
+excessive consolidation and concentration of
+economic power by establishing an excessive
+shares cap to limit the amount of quota any one
+person or corporation can own.
+
+ Regional council
+appointments: 
+
+Governor’s
+
+Recommendation 19-12. Congress should amend
+
+No similar recommendation.
+
+nominations
+
+the Magnuson-Stevens Fishery Conservation and
+Management Act to require governors to submit a
+broad slate of candidates for each vacancy of an
+appointed Regional Fishery Management Council
+seat. The slate should include at least two
+representatives each from the commercial fishing
+industry, the recreational fishing sector, and the
+general public.
+
+NOAA
+
+Recommendation 19-13. Congress should give
+
+No similar recommendation.
+
+Administrator’s
+
+the Administrator of the National Oceanic and
+
+responsibility
+
+Atmospheric Administration responsibility for
+appointing Regional Fishery Management
+Council members with the goal of creating
+regional councils that are knowledgeable, fair,
+and reflect a broad range of interests.
+
+ 
+ CRS-54
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Capacity
+reduction: 
+
+Objectives
+
+Recommendation 19-16. The National Oceanic
+
+For some severely depleted fisheries, it will be
+
+and Atmospheric Administration (NOAA) should
+
+necessary to develop a plan to reduce capacity
+
+implement programs to permanently reduce
+
+initially and to provide a mechanism that allows
+
+fishing capacity to sustainable levels.
+
+appropriate increases in catching capacity as the
+stock rebuilds. Each plan should set a catch
+capacity and fishing power goal appropriate for
+the fishery and require mechanisms and schedules
+for achieving that goal if the fishery has excess
+capacity. Capacity goals should be based upon
+appropriate ecological, social, and economic
+analyses of the relevant fishery and ecosystem. 
+The goal should be stated as a clear, measurable,
+and objective factor, or set of factors, that fairly
+represent the catching capacity or fishing power
+of the fleet.
+
+Buyback
+
+No similar recommendation.
+
+Reduce fishing capacity, where necessary, with
+
+programs
+
+transitional buyback programs and provide other
+transition assistance for displaced fishermen and
+affected fishing communities. Such programs
+should retire capacity permanently rather than
+allowing it to shift to other fisheries; restrict
+activation of latent fishing capacity in the
+buyback fishery. Place royalty payments in a
+secure fund to be used initially for buybacks and
+community economic development and then for
+cost recovery.
+
+Reduce subsidies
+
+Recommendation 19-16. Congress should repeal
+
+Reduce the incentives and subsidies that could
+
+the Fisheries Finance Program (formerly the
+
+encourage remaining fishery participants to
+
+Fishing Vessel Obligation Guarantee Program),
+
+increase their fish catching capacity.
+
+the Capital Construction Fund, and other
+programs that encourage overcapitalization in
+fisheries.
+
+ Limited access 
+
+No similar recommendation.
+
+Limit access and entry to all fisheries. Subject all
+participants in U.S. fisheries to permitting or
+licensing, both a general fishing permit/license as
+well as fishery-specific permits/licenses. Require
+that limited access/entry programs be designed to
+keep the level of catching capacity and fishing
+power in any fishery slightly under the level that
+is ecologically sustainable.
+
+ 
+ CRS-55
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Enforcement: 
+
+Funding
+
+Recommendation 19-17. Congress should
+
+Funds received from allocating fishing privileges
+
+increase funding for Joint Enforcement
+
+beyond cost recovery should go toward improved
+
+Agreements to implement cooperative fisheries
+
+fishery research, management, and enforcement.
+
+enforcement programs between NMFS/NOAA
+Fisheries and state marine enforcement agencies. 
+The U.S. Coast Guard should be included as an
+important participant in such agreements.
+
+Unified plan
+
+Recommendation 19-18. NMFS/NOAA
+
+No similar recommendation.
+
+Fisheries and the U.S. Coast Guard should
+strengthen cooperative enforcement efforts at the
+national level by developing a unified strategic
+plan for fisheries enforcement that includes
+significantly increased joint training, and at the
+regional and local levels, by developing a
+stronger and more consistent process for sharing
+information and coordinating enforcement.
+
+ Vessel
+Monitoring
+System: 
+
+Require for all
+
+Recommendation 19-19. NMFS/NOAA
+
+No similar recommendation.
+
+commercial
+
+Fisheries, working with the Regional Fishery
+
+vessels and
+
+Management Councils, the U.S. Coast Guard, and
+
+charter/party
+
+other appropriate entities, should maximize the
+
+boats
+
+use of the Vessel Monitoring System (VMS) for
+fishery-related activities by requiring that VMS
+with two-way communication capability be
+phased in for all commercial fishing vessels
+receiving permits under federal fishery plans,
+including party and charter boats that carry
+recreational fishermen, incorporating VMS
+features that assist personnel in monitoring and
+responding to potential violations, and identifying
+state fisheries that could significantly benefit
+from VMS implementation.
+
+Coast Guard lead
+
+Recommendation 19-20. The U.S. Coast Guard
+
+No similar recommendation.
+
+integration
+
+should be the lead organization in managing the
+integration of a fishery Vessel Monitoring System
+(VMS) database into the larger maritime
+operations database and should work with
+NMFS/NOAA Fisheries to ensure effective use of
+VMS data for monitoring and enforcement.
+
+ New entrants to 
+
+No similar recommendation.
+
+Each fishery should design a mandatory
+
+ fisheries 
+
+apprenticeship program to create a mechanism
+for new entrants to the fishery. These programs
+should foster improved stewardship through
+training in conservation and responsible fishing
+practices. Only those prospective new entrants
+who complete the program can receive a license.
+
+ 
+ CRS-56
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Ecosystem
+management: 
+
+Primary objective
+
+No similar recommendation.
+
+Redefine the principal objective of American
+marine fishery policy to protect marine
+ecosystems. The principal objective of American
+fishery policy should be to protect the long-term
+health and viability of fisheries by protecting,
+maintaining, and restoring the health, integrity,
+productive capacity, and resilience of the marine
+ecosystems upon which they depend. This
+objective should apply to all U.S. ocean waters. 
+Establish an explicit statutory priority between
+ecological and socioeconomic objectives. In
+cases of conflict between objectives or in cases
+where information is uncertain or inconclusive,
+the principal ecological objective should always
+take precedence over the socioeconomic
+objective, for the simple reason that achieving
+social and economic objectives depends upon
+healthy ecosystems.
+
+Habitat protection
+
+Recommendation 19-21. NMFS/NOAA
+
+Implement ecosystem-based fishery management. 
+
+Fisheries should change the designation of EFH
+
+Make marine ecosystems the organizing principle
+
+from a species-by-species to a multispecies
+
+for fishery management. Require that FMPs are
+
+approach and, ultimately, to an ecosystem-based
+
+developed based upon consideration of how the
+
+approach. The approach should draw upon
+
+entire ecosystem that supports the fishery will be
+
+existing efforts to identify important habitats and
+
+affected by fishing. Redefine overfishing in an
+
+locate optimum-sized areas to protect vulnerable
+
+ecosystem context to consider the level of fishing
+
+life-history stages of commercially important
+
+that has detrimental effects in the ecosystem,
+
+species.
+
+even though it may not harm a particular target
+species.
+
+Coordination
+
+Recommendation 19-21. NMFS/NOAA
+
+Regional ocean ecosystem councils should
+
+among
+
+Fisheries should work with other management
+
+coordinate with regional fishery management
+
+jurisdictions
+
+entities to protect EFH when such areas fall
+
+councils and other relevant entities. Regional
+
+outside their jurisdiction.
+
+ocean ecosystem councils should coordinate
+among these authorities to ensure that ecosystem
+health is taken into account at all levels of
+government. The regional ocean ecosystem
+councils’ role would be to consult with these
+entities regarding ecosystem concerns related to
+fisheries management, and to periodically assess
+overall progress toward achievement of the goals
+and policies of the regional ocean governance
+plans.
+
+ 
+ CRS-57
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Bycatch: 
+
+Reduction plans
+
+Recommendation 19-22. NMFS/NOAA
+
+Require bycatch monitoring and management
+
+Fisheries and Regional Fishery Management
+
+plans as a condition of fishing. The statutory
+
+Councils should develop regional bycatch
+
+goal of these plans should be to reduce bycatch to
+
+reduction plans that address broad ecosystem
+
+levels approaching zero. NMFS/NOAA Fisheries
+
+impacts of bycatch. Implementation of these
+
+should establish by regulation national criteria
+
+plans will require NMFS/NOAA Fisheries to
+
+that determine what constitutes an adequate and
+
+expand current efforts to collect data on bycatch,
+
+appropriate bycatch monitoring and minimization
+
+not only of commercially important species, but
+
+plan under different circumstances (e.g.,
+
+on all species captured by commercial and
+
+minimum observer coverage levels). Only plans
+
+recreational fishermen. The selective use of
+
+that meet these criteria and applicable federal
+
+observers should remain an important component
+
+laws should be approved. Each fishery should be
+
+of these efforts.
+
+allowed to develop its own plan. A tightly
+constructed stakeholder process modeled on the
+Marine Mammal Protection Act Take Reduction
+Teams should be the principal mechanism to
+develop these plans. The lobster zone councils
+used in the Maine lobster fishery provide another
+potential model.
+
+Endangered
+
+Recommendation 19-25. The National Plan of
+
+The statutory definition of bycatch should be
+
+species and
+
+Action should stress the importance of reducing
+
+broadened to include incidental mortality of all
+
+marine mammals
+
+bycatch of endangered species and marine
+
+non-target species (fish and other living marine
+
+mammals.
+
+resources), and mortality by lost or abandoned
+gear.
+
+Observer program
+
+No similar recommendation.
+
+Bycatch plans should include, at a minimum, an
+
+and monitoring
+
+observer program or other appropriate, effective
+monitoring scheme; total fishing mortality limits
+that include bycatch; and a requirement that
+bycatch mortality be factored into stock
+assessments.
+
+Quotas
+
+No similar recommendation.
+
+Individual bycatch quotas for valuable fish
+species (except threatened and endangered
+species) could be used to manage bycatch. 
+Conservative catch quotas should be set for
+species, accounting for intended and unintended
+catch. Fishermen should be allowed to keep fish
+they catch within conservative limits, rather than
+being forced to discard and waste one species
+because they are in a target fishery for another.
+
+ Endangered 
+
+Recommendation 20-3. The National Ocean
+
+No similar recommendation.
+
+ Species Act 
+
+Council should improve coordination between
+
+ coordination 
+
+NMFS/NOAA Fisheries and U.S. Fish and
+Wildlife Service with respect to the
+implementation of the Endangered Species Act,
+particularly for anadromous species or when
+land-based activities have significant impacts on
+marine species.
+
+ 
+ CRS-58
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ International
+Agreements: 
+
+Ratification and
+
+Recommendation 19-23. The U.S. Department
+
+No similar recommendation.
+
+incentives
+
+of State, working with other appropriate entities,
+should encourage all countries to ratify the Fish
+Stocks Agreement and the United Nations Food
+and Agriculture Organization’s Compliance
+Agreement. In particular, the United States
+should condition other nations’ access to fishing
+resources within the U.S. exclusive economic
+zone on their ratification of these agreements. 
+Other incentives should be developed by the
+United States and other signatory nations to
+encourage all nations to ratify and enforce these
+agreements.
+
+Funding for
+
+Recommendation 19-24. Congress should fully
+
+No similar recommendation.
+
+international
+
+fund existing U.S. commitments to international
+
+commissions
+
+fisheries management.
+
+Update
+
+Recommendation 19-24. The U.S. Department
+
+No similar recommendation.
+
+agreements to
+
+of State, working with the National Oceanic and
+
+harmonize
+
+Atmospheric Administration, should review and
+update regional and bilateral fishery agreements
+to which the United States is a party, to ensure
+full incorporation of the latest science and
+harmonize those agreements with the Fish Stocks
+Agreement.
+
+Encourage Code
+
+Recommendation 19-26. The international
+
+No similar recommendation.
+
+implementation
+
+committee of the National Ocean Council
+
+ 
+
+(discussed in Chapter 29), should initiate a
+discussion to determine the most effective
+methods of encouraging other nations to
+implement the United Nations Food and
+Agriculture Organization’s Code of Conduct for
+Responsible Fisheries and other Plans of Action
+and provide its findings to the U.S. Department
+of State and the National Ocean Council.
+
+ Derelict fishing
+gear: 
+
+Plan
+
+Recommendation 18-3. The U.S. Department of
+
+No similar recommendation.
+
+State and the National Oceanic and Atmospheric
+Administration, working with the United Nations
+Food and Agriculture Organization and other
+appropriate entities, should develop a detailed
+plan of action to address derelict fishing gear, to
+be implemented on a regional, multi-national
+basis.
+
+Coordination
+
+Recommendation 18-4. The National Oceanic
+
+No similar recommendation.
+
+and Atmospheric Administration should promote
+a public-private partnership program and
+implement strong incentives for removal and
+disposal of derelict fishing gear.
+
+ 
+ CRS-59
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Permanent trust 
+
+No similar recommendation.
+
+Establish a permanent Fishery Conservation and
+
+ fund 
+
+Management Trust Fund. The fund should be
+available without appropriation or fiscal year
+limitation. It should be used only for the
+purposes of improving fishery research, data
+collection, management, enforcement, and habitat
+restoration. In the first 5 to 10 years of operation,
+it should also be available for transitional
+buyback and community development programs. 
+Revenues should be applied within the region
+where they were collected. Within regions, the
+fund should be shared fairly among the federal
+government and state programs for coastal fishery
+management. The Secretary of Commerce should
+appoint regional advisory panels with equal
+representation from members of the industry,
+scientific community, conservation community,
+and appropriate local governments to ensure that
+revenues are apportioned fairly and wisely. The
+fund should not be used to defray the general
+costs of government or to absolve the federal
+government of responsibility to fund fishery and
+ecological research and science. Potential
+revenue sources for the fund include, but should
+not be limited to, revenues generated by royalty
+payments on landed catch (calculated as a
+percentage of the value of the landed fish) and
+fees collected from fines and other penalties.
+
+ New fisheries 
+
+No similar recommendation.
+
+Enact an emerging fisheries policy. The purpose
+of the policy should be to allow industry
+development of new fisheries in a manner that
+promotes sound scientific management and long-
+term conservation of the resources being
+developed and the relevant ecosystem. Potential
+development of new fisheries should be allowed
+through exploratory fishing permits. To obtain
+such a permit, applicants should work with the
+relevant fishery management authority to develop
+a research and management plan detailing how
+the necessary stock assessment and other research
+on and management of the stocks proposed for
+the new fishery will be funded and conducted. 
+Matching grants should be available for the
+industry to assist with management and
+administrative costs. If approved, the new fishery
+should only be allowed to expand if accumulated
+knowledge shows the fishery can grow in an
+ecologically sustainable manner.
+
+ Socioeconomic 
+
+No similar recommendation.
+
+The socioeconomic objective of American marine
+
+ objective 
+
+fishery policy should be to conserve and manage
+fisheries in order to support diversity, flexibility,
+resilience, and adaptability within the industry
+and fishing communities.
+
+ 
+ CRS-60
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Zoning: 
+
+Comprehensive
+
+No similar recommendation.
+
+Regional ocean governance plans should consider
+a full range of zoning options. This includes
+marine protected areas, areas designated for
+fishing, oil and gas development, as well as other
+commercial and recreational activities. Initially,
+area-based management should begin with
+coordinating existing zones in the ocean, such as
+areas closed to fishing, shipping lanes, and areas
+for oil and gas extraction.
+
+Specifically for
+
+No similar recommendation.
+
+Apply zoning in FMPs. Incorporate
+
+fishing
+
+comprehensive zoning within FMPs to
+proactively partition planned areas into sections
+designated for specific uses. Areas not
+designated for particular uses should be closed to
+those uses. Managers should evaluate the life
+history and habitat requirements of species to
+determine the appropriate types of area
+management tools to employ, including spatial
+and temporal closures, spawning closures, habitat
+protection areas, bycatch reduction areas, and
+marine reserves. Closed areas should be a
+required element for any FMP in which there is
+substantial uncertainty or lack of information
+about the status of heavily exploited major
+fishery stocks.
+
+Especially bottom
+
+No similar recommendation.
+
+Over a five-year transition period, implement a
+
+trawling
+
+zoning regime that (a) limits bottom trawling and
+dredging to only those areas where best available
+science indicates that such gear can be used
+without altering or destroying important or
+significant amounts of habitat; and (b) closes all
+other areas to these fishing practices.
+
+ 
+ CRS-61
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Ocean
+governance: 
+
+Participation
+
+No similar recommendation.
+
+Participation in regional ocean ecosystem
+councils by the broadest possible range of
+stakeholders — including fishermen and other
+ocean resource users — should occur through a
+robust and influential advisory process. Regional
+ocean governance plans need to be informed by
+the expertise and latest thinking of regional
+fishery management councils, metropolitan
+planning organizations, national estuary and
+watershed councils, and other local and regional
+authorities.
+
+Fisheries
+
+No similar recommendation.
+
+Regional ocean councils should leave day-to-day
+management to the appropriate authorities. For
+example, federal fisheries management would
+remain the purview of NMFS/NOAA Fisheries
+and the appropriate regional fishery management
+council. NMFS/NOAA Fisheries and the
+regional fishery management councils must
+ensure that their actions are consistent with
+applicable regional ocean governance plan(s). 
+Regional ocean councils should review proposed
+state, federal, and regional government actions
+and advise the agencies proposing these activities
+on consistency with regional ocean governance
+plans.
+
+ National Policy 
+
+Recommendation 19-25. The National Oceanic
+
+Require comprehensive access and allocation
+
+ and Plan 
+
+and Atmospheric Administration, working with
+
+planning as a condition of fishing. Establish a
+
+the U.S. Fish and Wildlife Service and the U.S.
+
+mandatory national policy to guide development
+
+Department of State, should design a National
+
+of fishery allocation plans. Each allocation plan
+
+Plan of Action for the United States that
+
+should, at a minimum, limit access and entry to
+
+implements, and is consistent with, the
+
+all fisheries to help shape and match the size of
+
+International Plans of Action adopted by the
+
+fishing fleets and their catching capacity to the
+
+United Nations Food and Agriculture
+
+health of exploited populations and the integrity,
+
+Organization and its 1995 Code of Conduct for
+
+productive capacity, and resilience of marine
+
+Responsible Fisheries. 
+
+ecosystems. Recover an appropriate share of the
+continuing costs of fisheries management,
+enforcement, and research as well as additional
+funds to mitigate potential adverse effects of
+fishery allocation plans on individuals and
+communities. Be subject to a double referendum
+where a super majority of the permit/license
+holders in a fishery approves the initial
+development as well as implementation of the
+plan. Be reviewed at least every five years. If
+appropriate, the plan should be revised to ensure
+it continues to meet the objectives of this policy,
+the public interest, other relevant laws and
+regulations, and fishery participants. Implement
+affirmative planning and management. Prohibit
+fishing without an approved plan. Require
+management of core problems such as bycatch,
+habitat damage, and overcapacity as a condition
+of fishing. Require a cooperative data-collection
+and planning program for existing fisheries where
+information is inadequate to determine whether
+overexploitation is occurring.
+
+ 
+ CRS-62
+
+ Issue 
+
+ U.S. Commission on Ocean Policy 
+
+ Pew Oceans Commission 
+
+ Mobile fishing
+gear impacts: 
+
+Regulation
+
+No similar recommendation.
+
+Regulate the use of fishing gear that is destructive
+to marine habitats. Create a fishing-gear zoning
+program designed to protect seafloor habitats
+from the adverse impacts of fishing practices. 
+The program should have an immediate and a
+transition phase. Regulations should be
+developed immediately to prohibit the use of
+mobile bottom fishing gear in habitat areas
+known to be especially sensitive to disturbance
+from such gear, including but not limited to coral-
+reef and deepwater coral habitats, complex rocky
+bottoms, seamounts, kelp forests, seagrass beds,
+and sponge habitats. Prevent expansion of
+mobile bottom gear into geographical areas
+where it is not presently employed. Prevent
+expansion of the numbers of vessels employing
+mobile bottom gear by restricting the numbers of
+licenses, permits, or endorsements to no more
+than current fleet sizes; allowing transfers of
+licenses only to gears that are documented to
+have lower impacts on habitats; and allowing
+reentry of latent mobile gear effort only with
+gears documented to have lower impacts on
+habitats. Convene an independent panel to
+develop rigorous scientific criteria and implement
+a science-based process for designating zones
+open to mobile bottom gear fishing. Implement a
+gear-substitution program to reduce the use of
+mobile bottom gear by conducting a viability
+assessment to determine fisheries dependent on
+such gear; and providing funding to replace gear
+in fisheries that cannot be viably conducted
+without mobile bottom gear. Close areas to
+mobile bottom gear fishing if NMFS/NOAA
+Fisheries fails to implement the zoning regime by
+the end of five years, unless and until it has been
+determined that the best available science
+indicates such gear can be used without altering
+or destroying important or significant amounts of
+habitat or reducing biodiversity.
+
+Specifically, coral
+
+Recommendation 21-2. Congress should codify
+
+No similar recommendation.
+
+reefs
+
+and strengthen the U.S. Coral Reef Task Force,
+placing it under the National Ocean Council. The
+task force should coordinate the development of
+regional ecosystem-based plans to address the
+impacts of nonpoint source pollution, fishing, and
+other activities on coral resources.
\ No newline at end of file
diff --git a/corpus/politics/text/59d2b4d4d8760b6a.txt b/corpus/politics/text/59d2b4d4d8760b6a.txt
new file mode 100644
index 0000000000000000000000000000000000000000..1c06767cc297219da65634f4e066b3a99ce86ccf
--- /dev/null
+++ b/corpus/politics/text/59d2b4d4d8760b6a.txt
@@ -0,0 +1,7088 @@
+Child Welfare: An Overview of Federal Programs and Their Current Funding
+
+ December 19, 2017
+ (R43458)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ Introduction 
+
+ Status of FY2018 Appropriations 
+
+ FY2017 Appropriations 
+
+ How Is the Level of Federal Child Welfare Funding Determined Each Year? 
+
+ Sequestration and Child Welfare Funding 
+
+ Federal Child Welfare Programs 
+
+ Title IV-B of the Social Security Act 
+
+ Stephanie Tubbs Jones Child Welfare Services 
+
+ Planned Use of Funds 
+
+ Distribution 
+
+ Funding 
+
+ Promoting Safe and Stable Families Program 
+
+ Planned Use of Funds 
+
+ Funding 
+
+ Distribution of PSSF Child and Family Services Funding 
+
+ Reservation and Distribution of PSSF Funds for Other Grants and Activities 
+
+ Family Connection Grants 
+
+ Child Welfare Research, Training, or Demonstration Projects 
+
+ National Survey of Child and Adolescent Well-Being (NSCAW) 
+
+ Title IV-E of the Social Security Act 
+
+ Foster Care 
+
+ Funding Available for Costs of Providing Foster Care to Eligible Children 
+
+ Waivers 
+
+ Foster Care Funding Authorized 
+
+ Adoption Assistance 
+
+ Eligibility for Title IV-E Adoption Assistance for Special Needs Adoptees 
+
+ Kinship Guardianship Assistance 
+
+ Obligations of Funds by Title IV-E Program Component 
+
+ Tribal Title IV-E Plan Development and Technical Assistance 
+
+ Chafee Foster Care Independence Program 
+
+ Chafee Educational and Training Vouchers (ETVs) 
+
+ Funding and Distribution for the CFCIP Program, Including ETVs 
+
+ Adoption and Legal Guardianship Incentive Payments 
+
+ Child Abuse Prevention and Treatment Act (CAPTA) 
+
+ CAPTA State Grants 
+
+ Selected Amendments in the 2010 CAPTA Reauthorization and Other Subsequent Changes 
+
+ Funding and Distribution 
+
+ CAPTA Discretionary Activities 
+
+ Community-Based Grants to Prevent Child Abuse and Neglect 
+
+ Children's Justice Act Grants 
+
+ Victims of Child Abuse Act 
+
+ Improving Investigation and Prosecution of Child Abuse Cases 
+
+ Court-Appointed Special Advocates 
+
+ Child Abuse Training for Judicial Personnel and Practitioners 
+
+ Other Programs 
+
+ Adoption Opportunities 
+
+ Abandoned Infants Assistance 
+
+ 
+ 
+ Tables
+
+ 
+ Table 1. Final Funding Estimates for Child Welfare Programs 
+
+ Table 2. Final Funding for Stephanie Tubbs Jones Child Welfare Services Program 
+
+ Table 3. Final Funding for Promoting Safe and Stable Families (PSSF) Program 
+
+ Table 4. Final Discretionary and Mandatory PSSF Funding, by Program/Activity 
+
+ Table 5. Final Funding for Family Connection Grants 
+
+ Table 6. Final Funding for Child Welfare Research, Training, or Demonstration 
+
+ Table 7. Funding Under the Title IV-E Program for Foster Care and Permanency 
+
+ Table 8. Final Funding for Tribal Title IV-E Plan Development and Technical Assistance (TA) 
+
+ Table 9. Final Funding for the Chafee Foster Care Independence Program (CFCIP) 
+
+ Table 10. Final Funding for Adoption and Legal Guardianship Incentive Payments 
+
+ Table 11. Final Funding for Child Abuse Prevention and Treatment Act (CAPTA) 
+
+ Table 12. Final Funding for Children's Justice Act Grants 
+
+ Table 13. Final Funding for Programs Under the Victims of Child Abuse Act (VCAA) 
+
+ Table 14. Final Funding for Adoption Opportunities 
+
+ Table 15. Final Funding for Abandoned Infants Assistance 
+
+ Table A-1. Child Welfare Program Funding by Fiscal Year 
+
+ Table B-1. Funding Authority and Sequestration Status of Child Welfare Programs 
+
+ Table D-1. Jurisdictions Extending Title IV-E Assistance Beyond Age 18 
+
+ Table E-1. Jurisdictions Implementing Child Welfare Waiver Projects. 
+
+ Table F-1. Jurisdictions Approved to Provide Title IV-E Kinship Guardianship Assistance 
+
+ Table G-1. Incentive Payments Earned for Increases in Adoption and Legal Guardianships Completed in FY2016 
+
+ 
+ 
+
+ 
+ Appendixes
+
+ 
+ Appendix A. Recent Funding by Program 
+
+ Appendix B. Child Welfare Programs by Type of Funding Authority and Sequestration Status 
+
+ Appendix C. Tribes with an Approved Title IV-E Plan 
+
+ Appendix D. States with Approval to Extend Title IV-E Assistance up to Age 21 
+
+ Appendix E. States with Child Welfare Demonstration (Waiver) Projects 
+
+ Appendix F. Jurisdictions with Approval to Provide Title IV-E Kinship Guardianship Assistance 
+
+ Appendix G. Adoption and Legal Guardianship Incentive Payments 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ Child welfare services are intended to prevent the abuse or neglect of children; ensure that children have safe, permanent homes; and promote the well-being of children and their families. As the U.S. Constitution has been interpreted, states bear the primary authority for ensuring the welfare of children and their families. The federal government has shown long-standing interest in helping states improve their services to children and families and, through the provision of federal support, requires states to meet certain child welfare requirements. For FY2017, an estimated $8.9 billion in federal support was made available for child welfare purposes. FY2018 began on October 1, 2017, but final funding levels for that year have not yet been determined. In the meantime, funding to continue child welfare programs in this new fiscal year has been provided via short-term funding measures, including P.L. 115-56 (through December 8, 2017) and P.L. 115-90 (through December 22, 2017).
+
+ Federal support for child welfare activities is provided via multiple programs. The largest share of this federal child welfare funding is provided for support of children in foster care, and for ongoing assistance to children who leave foster care for new permanent families (via adoption or legal kinship guardianship). Federal support for these child welfare purposes is authorized in Title IV-E of the Social Security Act. It is annually appropriated at the level needed to support a specified share of the cost incurred by states in providing foster care, adoption assistance, or kinship guardianship assistance to eligible children. The federal share of that cost was estimated at $7.5 billion in FY2016 and, as of the July 2017 mid-session budget review, was expected to be $7.8 billion in FY2017. 
+
+ Federal funding for all other child welfare activities remained at $1.1 billion in FY2017, which was the same level provided in FY2016. This funding is primarily authorized via Title IV-B of the Social Security Act (for child welfare related services to children and their families), as well as some separate authorizations of funding in Title IV-E of the Social Security Act (related to services for older youth in care and those who "age out" of care and for Adoption and Legal Guardianship Incentive Payments), and in multiple program authorizations included in the Child Abuse Prevention and Treatment Act (CAPTA), Adoption Opportunities, and the Victims of Child Abuse Act. Federal support provided annually for this broad range of child welfare activities is a fixed sum that is determined during the yearly discretionary appropriations process or is based on a mandatory dollar amount specified in the program authorizing law.
+
+ Legislation concerning welfare programs authorized under Title IV-E and Title IV-B is handled in the House Ways and Means and Senate Finance committees; legislation concerning grants and activities authorized by CAPTA and Adoption Opportunities is handled in the House Education and the Workforce and Senate Health, Education, Labor, and Pensions (HELP) committees; legislation concerning the grant programs in the Victims of Child Abuse Act is handled in the House and Senate Judiciary committees.
+
+ At the federal level, these child welfare programs are primarily administered by the Children's Bureau, which is an agency within the Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS). Nearly all federal child welfare dollars (97%) were provided to state, tribal, or territorial child welfare agencies (via formula grants or as federal reimbursement for a part of all eligible program costs). The remaining federal child welfare dollars (3%) are provided to a variety of eligible public or private entities, primarily on a competitive basis. This money supports research, evaluation, technical assistance, and demonstration projects to expand knowledge of, and improve, child welfare practice and policy.
+
+ 
+ 
+ Child Welfare: An Overview of Federal Programs and Their Current Funding
+
+ Introduction
+
+ Child welfare services are intended to prevent the abuse or neglect of children; ensure that children have safe, permanent homes; and promote the well-being of children and their families. 
+
+ As the U.S. Constitution has been interpreted, states have the primary authority to ensure the welfare of children and their families. At the state level, the child welfare "system" consists of public and private child protection and child welfare workers, public and private social services workers, state and local judges, prosecutors, and law enforcement personnel. These agents of various state and local entities assume interrelated roles while carrying out child welfare activities, including 
+ promoting child and family well-being through community-based activities;
+
+ investigating, or otherwise responding to, allegations of child abuse and neglect;
+
+ providing services to families to ensure children's safety in the home; 
+
+ removing children from their homes when that is necessary for children's safety;
+
+ supervising and administering payments for children placed in foster care; 
+
+ ensuring regular case review and permanency planning for children in foster care; 
+
+ helping children leave foster care to permanent families via reunification with parents or, when that is not possible, via adoption or legal guardianship; 
+
+ offering post-permanency services and supports to maintain families; and 
+
+ helping older children in foster care, and youth who leave care without placement in a permanent family, to become successful adults.
+ Federal involvement in child welfare is primarily tied to the financial assistance it provides to states and most federal dollars dedicated to child welfare purposes are provided to state child welfare agencies for the provision of foster care. As a condition of receiving these foster care and certain other child welfare program funds, states must typically provide nonfederal resources of between 20% and 50% of the program costs, and they are required to abide by a series of federal child welfare policies. Those policies are designed to ensure the safety and well-being of all children and families served. However, the most specific and extensive federal requirements concern the protection of children in foster care, especially to ensure them a safe and permanent home. 1 
+
+ Federal child welfare funding is primarily provided as part of the annual appropriations bill for the Departments of Labor, Health and Human Services (HHS), and Education and is included in the HHS, Administration for Children and Families (ACF) account. These funds are provided on both a mandatory and a discretionary basis and are administered by the federal Children's Bureau, which is a part of the Administration on Children, Youth, and Families (ACYF) within the ACF. Separately, discretionary funding for several child welfare programs authorized by the Victims of Child Abuse Act is provided in the annual appropriations bill for the Departments of Commerce and Justice. Those program funds are administered at the federal level in the Department of Justice (DOJ), Office of Justice Programs (OJP). 
+
+ Table 1 summarizes child welfare funding provided in recent years. 
+
+ 
+ 
+ Table 1. Final Funding Estimates for Child Welfare Programs
+
+ (nominal dollars in millions; parts may not sum to total due to rounding)
+
+ 
+
+ 
+ 
+ 
+ Child Welfare Programs 
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017 a 
+
+ 
+ 
+ 
+ 
+ TOTAL — All Programs 
+
+ 
+ 
+ $7,578 
+
+ 
+ 
+ $8,390 
+
+ 
+ 
+ $8,27 9 
+
+ 
+ 
+ $8, 603 
+
+ 
+ 
+ $ 8,898 
+
+ 
+ 
+ 
+ 
+ Title IV-B —all programs
+
+ 
+ 
+ $688
+
+ 
+ 
+ $689
+
+ 
+ 
+ $664
+
+ 
+ 
+ $668
+
+ 
+ 
+ $668
+
+ 
+ 
+ 
+ 
+ Title IV —all programs
+
+ 
+ 
+ $6,710
+
+ 
+ 
+ $7,510
+
+ 
+ 
+ $7,424
+
+ 
+ 
+ $7,746
+
+ 
+ 
+ $8,041
+
+ 
+ 
+ 
+ 
+ Other — all other programs
+
+ 
+ 
+ $180
+
+ 
+ 
+ $192
+
+ 
+ 
+ $190
+
+ 
+ 
+ $188
+
+ 
+ 
+ $189
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS).
+
+ Notes: Title IV-B and Title IV-E are parts of the Social Security Act. A child welfare program or activity was included in the "Title IV-B" or "Title IV-E" category if its authorization of funding was included in that part of the law. Remaining child welfare programs were grouped in the category "Other." For a list of programs by these categories, see Appendix A . Final funding amounts reflect any effects of sequestration. 
+
+ Title IV-E mandatory funding amounts included in this table are based (for FY2017) on estimated budget authority determined as of the July 2017 Mid-Session Budget Review, and (for all earlier fiscal years) the most current data on federal obligations made/expected as shown in the relevant U.S. Department of Health and Human Services (HHS), Administration for Children and Families (ACF) J ustifications for the Appropriations Committee . The Title IV-E amounts shown in this table may vary from earlier versions of this report because obligation or budget authority levels reported may change and/or because versions of this table included in earlier versions of this report showed Title IV-E funding as the amount of "definite budget authority" provided. 
+
+ a. The FY2017 total is different than the FY2017 "final funding" number shown in CRS Report R44863, Child Welfare Funding in Brief: FY2017 Final Funding and the President's FY2018 Request . This difference is solely related to the estimated level of Title IV-E funding for foster care, adoption assistance, and guardianship assistance. CRS Report R44863, Child Welfare Funding in Brief: FY2017 Final Funding and the President's FY2018 Request shows the FY2017 estimates that HHS used to make the FY2018 request. However, those estimates are revised based on actual obligations and so may change. Accordingly, the Title IV-E numbers used in this report are based on the a more recent HHS re-estimate of necessary Title IV-E budget authority as prepared for the Mid-Session Budget Review (released July 2017). 
+
+ 
+
+ 
+
+ Apart from the child welfare-specific (dedicated) federal funding shown in Table 1 and provided for programs described in this report, state child welfare agencies tap significant program resources—as much as $5.0 billion—from other federal funding streams. 2 Often these include the Temporary Assistance for Needy Families (TANF) block grant, the Social Services Block Grant (SSBG), and Medicaid. 3 These federal funding streams have federal statutory goals, or support activities, that overlap with child welfare purposes. However, they are not solely dedicated to child welfare purposes, and states are not necessarily required to use them for those specific purposes. Neither do states need to meet federal requirements specific to the conduct of their child welfare programs as a condition of receiving this "non-dedicated" funding. 4 
+
+ This report begins with an overview of FY2018 appropriations activities for child welfare programs through mid-December 2017, followed by a discussion of final appropriations actions for FY2017. It then includes a discussion of how annual funding levels are determined for child welfare programs and briefly discusses the effect of sequestration on that child welfare funding. The remainder, and largest part, of the report provides descriptions of each federal child welfare program, including its purpose and recent (FY2013-FY2017) funding levels.
+
+ Status of FY2018 Appropriations 
+
+ FY2018 began on October 1, 2017, before passage of final FY2018 appropriations. To allow for continuation of most federal programs and activities, Congress has approved two short-term continuing resolutions (CRs). The first (Division D of P.L. 115-56 ) provided funding through December 8, 2017. The second (Division A of P.L. 115-90 ) extends funding for FY2018 through December 22, 2017, or the date on which final full-year appropriations are enacted, whichever comes first.
+
+ Funding authority for a number of child welfare programs has expired, but the FY2018 funding measures continue support for each of the child welfare programs that received funding in the previous year. Under the current CR, for each child welfare program that receives discretionary funding, the funding level provided is based on the program's FY2017 appropriation level, reduced by an "across-the-board" amount of 0.6791%. 5 Child welfare funding provided on a discretionary basis for FY2017 totaled close to $597 million. On an annualized basis, a 0.6791% reduction of that overall sum would provide total child welfare discretionary funding of around $593 million (or about 99.3% of the FY2017 total).
+
+ For those child welfare programs receiving annual appropriated mandatory funding, the CR provides that funding is available to maintain current law program needs under the authority and conditions provided for those programs in FY2017. 6 Principally, those child welfare programs receiving some or all of their funding on an appropriated mandatory basis are the federal Title IV-E foster care, adoption assistance, and kinship guardianship assistance program; the Promoting Safe and Stable Families (PSSF) program; and the Chafee Foster Care Independence Program basic grants. 
+
+ Until a final FY2018 appropriations bill is enacted, the total child welfare funding that will be provided remains uncertain and may be less (or more) than the annualized levels provided in the CR. Accordingly, the CR stipulates that in continuing projects and activities, only the most limited funding actions may be taken. 7 
+
+ FY2017 Appropriations
+
+ The Consolidated Appropriations Act, 2017 ( P.L. 115-31 ), provides some $8.9 billion for child welfare programs, including an estimated $7.8 billion for foster care, adoption assistance, and kinship guardianship assistance, and $1.1 billion for all other child welfare activities, services, and research. Compared to FY2016 funding levels, HHS estimated support for foster care, adoption assistance, and kinship guardianship would increase for FY2017. Funding provided for all remaining child welfare activities remained generally unchanged from FY2016.
+
+ Although FY2017 began on October 1, 2016, full-year FY2017 appropriations levels for most federal programs and operations were not enacted until May 5, 2017. To allow for continuation of these activities in the interim, Congress approved three short-term continuing resolutions. The first (Division C of P.L. 114-223 ) provided funding through December 9, 2016. The second continuing resolution (Division A of P.L. 114-254 ) extended funding through April 28, 2017, and the third continuing resolution ( P.L. 115-30 ) extended funding until enactment of the Consolidated Appropriations Act, 2017, on May 5, 2017 ( P.L. 115-31 ). 
+
+ How Is the Level of Federal Child Welfare Funding Determined Each Year?
+
+ Nearly all child welfare funds are provided (appropriated) in annual appropriations acts. The amount of funding provided for a given program is controlled through the appropriations process, or in the case of programs receiving mandatory funding, via the authorizing legislation. 
+
+ The largest share of federal support for child welfare is provided to maintain children in foster care and for ongoing assistance to children who leave foster care for adoption or kinship guardianship. Funding for these purposes is authorized under Title IV-E of the Social Security Act on a "mandatory" and "open-ended" basis. Under this kind of funding authorization, the federal government is committed to paying a part of the cost of all eligible program expenditures made on behalf of children meeting federal eligibility criteria. Accordingly, the annual appropriation level specified by Congress for IV-E foster care, adoption assistance, and kinship guardianship assistance typically matches the amount of funding the Administration estimates (in its budget request) as necessary for the federal government to meet its commitment under the current program authorizing law. In the event this amount is underestimated, there is typically included in the appropriations act language that authorizes HHS to draw additional funds from the federal Treasury to meet federal program obligations for the year. Alternatively, if the Administration overestimates funding needed this amount will lapse (no longer be available for expenditure from the federal Treasury). 8 
+
+ Funding for all other child welfare programs is authorized on either a "discretionary" or a "capped mandatory" basis. A capped mandatory funding authorization includes a specific dollar amount written into the authorizing law. The primary child welfare programs with this type of funding authorization are the Chafee Foster Care Independence Program (general program) and the Promoting Safe and Stable Families (PSSF) program. Most child welfare programs have discretionary funding authorizations. For these programs, the level of funding is decided as part of the annual appropriations process. The Stephanie Tubbs Jones Child Welfare Services (CWS) program, Adoption Opportunities, Adoption and Legal Guardianship Incentive Payments, and various grants authorized under the Child Abuse Prevention and Treatment Act (CAPTA) are examples of child welfare programs with funding authorized on a discretionary basis. 9 (For a complete list of programs by type of funding authority, see Appendix B .)
+
+ Sequestration and Child Welfare Funding
+
+ Sequestration generally means application of an across-the-board spending cut. For non-exempt mandatory programs, it is currently scheduled to apply in every year through FY2025. For non-exempt programs with discretionary funding, it ma y be required in any year through FY2021 (but only if one or both of the discretionary spending caps specified in the statute is exceeded). 10 
+
+ Mandatory child welfare funding provided under Title IV-E of the Social Security Act is specified in statute as exem pt from sequestration and is, for the most part, not subject to a required automatic reduction of appropriations. 11 This exempt Title IV-E funding represents by far the largest share of all federal child welfare funding and includes the mandatory Title IV-E funding for foster care, adoption assistance, guardianship assistance, and the Chafee Foster Care Independence Program. 
+
+ Mandatory funding provided under Title IV-B of the Social Security Act as part of the Promoting Safe and Stable Families (PSSF) program is classified as non-exempt. This means that, beginning with FY2013, mandatory funding provided for the PSSF program has been subject to annual reductions (or sequestration), ranging from a low of 5.1% to a high of 7.2%. For FY2018, the funding cut is 6.6%, 12 a slightly smaller reduction than the 6.9% applied for FY2017 that reduced FY2017 PSSF mandatory dollars by roughly $24 million (applied proportionately across all the activities funded by mandatory PSSF dollars, such as child and family services, Regional Partnership Grants, and Court Improvement). 13 The dollar effect of the FY2018 sequestration on mandatory PSSF funding cannot be determined until the final PSSF mandatory funding level has been given.
+
+ All child welfare programs with discretionary funding are non-exempt, and each was subject to sequestration in FY2013 (resulting in a 5.0% reduction in appropriated funding). In each subsequent fiscal year through FY2017, however, the Office of Management and Budget (OMB) determined that discretionary funds appropriated did not exceed the caps established by the Budget Control Act (as amended) and thus no sequestration was applicable. 14 A determination about any needed discretionary sequestration for FY2018 cannot be made until after final appropriations have been enacted. For a description of sequestration by year and a table showing child welfare programs by their type of funding authority and status as "exempt" or "nonexempt," see Appendix B .
+
+ Federal Child Welfare Programs
+
+ Federal child welfare programs are described below. Each description includes program purposes, the final funding level in each of FY2013-FY2017, and the type and status of the program's funding authority. 15 Unless otherwise specified, the term states refers to the 50 states and the District of Columbia, and the term territories refers to Puerto Rico, Guam, American Samoa, Northern Mariana Islands, and the U.S. Virgin Islands.
+
+ Title IV-B of the Social Security Act
+
+ Title IV-B of the Social Security Act principally authorizes support for child welfare activities that is provided to states, territories, and tribes under two formula grant programs. Separately it authorizes funding for related research, training, and other projects; this funding is competitively awarded to eligible entities. 16 Legislation authorizing these Title IV-B programs and activities is handled by the House Committee on Ways and Means and the Senate Committee on Finance.
+
+ Stephanie Tubbs Jones Child Welfare Services 
+
+ Known as "Child Welfare Services," this program authorizes formula grant funding to states, territories, and tribes to support services and activities intended to 
+ protect and promote the welfare of all children; 
+
+ prevent child abuse, neglect, or exploitation; 
+
+ permit children to remain in their own homes or return to them whenever it is safe and appropriate; 
+
+ promote safety, permanency, and well-being for children in foster care and adoptive families; and 
+
+ provide training to ensure a well-qualified child welfare workforce.
+ There are no federal eligibility criteria for recipients. Instead, states may elect to fund services and activities to meet these goals on behalf of any child or family that they determine to be in need of them. To receive these funds, states must meet federal requirements, many of which are designed to ensure all children in foster care receive certain permanency planning and other protections. 17 
+
+ Planned Use of Funds
+
+ While state spending patterns vary, for FY2017 states collectively planned to spend the largest part of their federal Child Welfare Services funding (44%) on child protective services. These services may include investigations of child abuse and neglect, caseworker activities on behalf of children and their families (both those in foster care and those at home), counseling, emergency assistance, and arranging alternative living arrangements. Additionally, states planned to spend a combined 30% of this funding on three categories of services: family support, family preservation, and time-limited family reunification services. These services are intended to strengthen families to promote family and child well-being, as well as to enable children to remain safely at home, or if they have entered foster care, to be returned safely home. 
+
+ Collectively states expected to spend remaining federal FY2017 CWS funds as follows: 10% for foster care maintenance payments (to pay the room and board cost of a child's stay in foster care); 6% for program administration; 5% for services to promote and support adoption and for adoption and guardianship subsidies; and 5% for other activities, services, or planning, including training and foster and adoptive parent recruitment. 18 
+
+ Distribution
+
+ All states receive a base allotment of $70,000 in CWS funding. The remaining program appropriations are distributed to states based on their relative share of the population of children (individuals under age 21), with a higher per child federal funding level provided to states with lower per capita income. Generally, to receive its full federal allotment of CWS funding, each state must provide nonfederal resources equaling no less than 25% of all funds spent under this program. 19 Tribal allotments are reserved by HHS out of a state's Child Welfare Services allotment based in large part on a tribe's share of the state's child (under age 21) population.
+
+ Funding
+
+ Funding for Child Welfare Services was first authorized in 1935 as part of the original Social Security Act and is currently included at Title IV-B, Subpart 1 of that act. Most recently, annual discretionary funding of $325 million was authorized for the program through FY2016 (i.e., through September 30, 2016). 20 Congress, however, may choose to extend CWS funding without explicit funding authorization, and with P.L. 115-31 it continued federal support for the program through FY2017 at just below $269 million; this is the same nominal dollar level provided for CWS in FY2016. Table 2 shows final funding for the program in each of FY2013-FY2017.
+
+ 
+ 
+ Table 2. Final Funding for Stephanie Tubbs Jones Child Welfare Services Program
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Child Welfare Services
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Formula grants to states, territories, and tribes
+
+ 
+ 
+ $262.6
+
+ 
+ 
+ $268.7
+
+ 
+ 
+ $268.7
+
+ 
+ 
+ $268.7
+
+ 
+ 
+ $268.7
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS).
+
+ Note s : The FY2013 funding shown reflects the final operating level after application of sequestration. For recent CWS funding by state, see Table 11-9A in House Ways and Means Committee, 2016 Green Book, Chapter 11, Child Welfare. 
+
+ 
+
+ 
+
+ Promoting Safe and Stable Families Program
+
+ The Promoting Safe and Stable Families (PSSF) program authorizes formula grant funding to states, tribes, and territories for services to 
+ strengthen at-risk families and prevent maltreatment; 
+
+ preserve families and ensure children's safety and well-being by providing services that allow children to safely remain with (or return) to their families; 
+
+ address problems of families whose children have been placed in foster care (to enable timely reunification); and 
+
+ support adoptive families by providing supportive services necessary for them to make a lifetime commitment to their children.
+ To receive these funds, states must meet certain federal requirements, which are primarily related to state planning for comprehensive services to children in families. 21 
+
+ The statute also provides that before PSSF funds are distributed to states for support of these services, a part of the program's funding must be reserved for other grants and activities, including grants under the Court Improvement Program and Regional Partnership Grants. (These, and other reservations of PSSF funds, are described further below.) 
+
+ Planned Use of Funds
+
+ States receiving PSSF funds are required to spend a "significant" portion of this federal funding (generally interpreted in guidance as at least 20% of the federal dollars) on each of four defined service categories: family support, family preservation, time-limited family reunification, and adoption promotion and support. For FY2017, states collectively planned to spend their federal PSSF funding as follows: 26% for family support services, 23% for family preservation services, 22% for adoption promotion and support services, and 22% for time-limited family reunification services (i.e., services intended to enable children who have been in foster care for no more than 15-17 months to return safely to their homes). Remaining funds were to be spent for program administration (7%) or other program costs, including planning (2%). 22 
+
+ Funding
+
+ The PSSF program was added to the Social Security Act (Title IV-B, Subpart 2) in 1993 ( P.L. 103-66 ). Most recently combined mandatory and discretionary funding for the program was authorized (through FY2016) at $545 million/year. Congress has never funded the program at its full authorized level. Final funding made available for PSSF (including all related activities) has for many years been less than the total authorized level. This is because (1) Congress has never provided the full level of discretionary funding authorized beginning in FY2002, and (2) in more recent years, some or all of the funding provided has been subject to sequestration. Across FY2013-FY2017, sequestration has reduced final PSSF funding by a combined $118 million (or, on average, a little less than $24 million in each of those five years). 23 
+
+ For FY2017, despite the expired funding authorizations, Congress provided PSSF (and related activities) funding totaling $381 million. This amount is comparable to the FY2016 funding level for the same program activities. Final FY2017 PSSF funding was provided in three (instead of two) parts: $325 million for mandatory PSSF purposes, $60 million for discretionary PSSF purposes, and $20 million in mandatory funds for two of the three Court Improvement Program (CIP) grants. 24 After sequestration of 6.9% of mandatory funds, the total available for PSSF (including all CIP funding) summed to just under $381 million. Table 3 shows actual program funding (i.e., the amount made available after sequestration) for each of FY2013-FY2017. 
+
+ 
+ 
+ Table 3. Final Funding for Promoting Safe and Stable Families (PSSF) Program
+
+ (nominal dollars in millions; parts may not sum to total due to rounding)
+
+ 
+
+ 
+ 
+ 
+ PSSF Funding
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL (mandatory and discretionary) 
+
+ 
+ 
+ $387 .1 
+
+ 
+ 
+ $379 .9 
+
+ 
+ 
+ $379.6 
+
+ 
+ 
+ $381.3 
+
+ 
+ 
+ $381.0 
+
+ 
+ 
+ 
+ 
+ Mandatory funding 
+
+ 
+ 
+ $327.4
+
+ 
+ 
+ $320.2
+
+ 
+ 
+ $319.8
+
+ 
+ 
+ $321.5
+
+ 
+ 
+ $321.2 a 
+
+ 
+ 
+ 
+ 
+ Discretionary funding 
+
+ 
+ 
+ $59.7
+
+ 
+ 
+ $59.8
+
+ 
+ 
+ $59.8
+
+ 
+ 
+ $59.8
+
+ 
+ 
+ $59.8
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note: The funding levels shown reflect any required sequestration, which in FY2013 applied to both the mandatory and discretionary funding, and for FY2014 - FY2017 applied to the mandatory funds only. For recent PSSF funding by state, see Table 11-9A in House Ways and Means Committee, 2016 Green Book , Chapter 11 . 
+
+ a. This amount includes $325 million in mandatory PSSF funds (Division H of P.L. 115-31 ) and a separate mandatory appropriation of $20 million (Division M of P.L. 115-31 ). After application of sequestration, the combined funding totaled $321.2 million. The separate $20 million appropriation was made to ensure funding for two grants authorized under the Court Improvement Program (CIP). In each of FY2013-FY2016, these grants were supported with funds set aside from mandatory PSSF dollars, which also support a third CIP grant. The Congressional Budget Office (CBO) does not consider funding for two of the three CIP grants to be a part of the PSSF mandatory baseline. The effect of the separate appropriations, and accompanying legislative language in Divisions H and M of P.L. 115-31 , is to fund PSSF, including all three CIP grants, at the FY2016 level without lowering the PSSF mandatory baseline from its FY2017 level of $325 million. (The slight difference shown in the table between FY2016 and FY2017 mandatory dollars is solely due to sequestration; the overall appropriation amounts were identical.)
+
+ 
+
+ 
+
+ Distribution of PSSF Child and Family Services Funding
+
+ PSSF funds for child and family services are distributed to states based on their relative share of the national population of children receiving Supplemental Nutrition Assistance Program (SNAP) benefits (most recent three-year average). To receive its full federal allotment, each state must provide nonfederal resources equaling no less than 25% of funds spent under this program. 
+
+ Reservation and Distribution of PSSF Funds for Other Grants and Activities 
+
+ Apart from funding child and family services, the statute requires specified amounts of PSSF funding to be reserved each year for related programs and activities. These include the Court Improvement Program, Regional Partnership Grants (to improve outcomes for children affected by parental substance abuse), Monthly Caseworker Grants, and program-related evaluation and research. Therefore, before PSSF funds are distributed to states and territories for provision of child and family services, the law provides specific dollar or percentage amounts that HHS must set aside for each of these programs or activities. 25 
+
+ Table 4 shows all PSSF funding (mandatory and discretionary) divided by purpose or activity for each of FY2013-FY2017. For FY2017, the funding shown includes the separate appropriation provided for the Court Improvement Program, as noted above. In all fiscal years, the amount shown as funding for "services to children and families" is what remains after the required reservations of funds for specific purposes or activities.
+
+ 
+ 
+ Table 4. Final Discretionary and Mandatory PSSF Funding, by Program/Activity
+
+ (nominal dollars in millions; parts may not sum to total due to rounding)
+
+ 
+
+ 
+ 
+ 
+ PSSF Program or Activity 
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL (mandatory and discretionary)
+
+ 
+ 
+ $387 .1 
+
+ 
+ 
+ $ 379.9 
+
+ 
+ 
+ $ 379.6 
+
+ 
+ 
+ $381.3 
+
+ 
+ 
+ $381 .0 
+
+ 
+ 
+ 
+ 
+ Services to children and families —
+Formula grants to states and territories 
+
+ 
+ 
+ $300.5
+
+ 
+ 
+ $295.2
+
+ 
+ 
+ $294.9
+
+ 
+ 
+ $296.0
+
+ 
+ 
+ $295.6
+
+ 
+ 
+ 
+ 
+ Tribal services to children and families —Formula grants to tribes 
+
+ 
+ 
+ $10.5
+
+ 
+ 
+ $10.3
+
+ 
+ 
+ $10.3
+
+ 
+ 
+ $10.5
+
+ 
+ 
+ $10.5
+
+ 
+ 
+ 
+ 
+ State Court Improvement Program —
+Formula grants to state highest courts
+
+ 
+ 
+ $29.5
+
+ 
+ 
+ $28.9
+
+ 
+ 
+ $28.9
+
+ 
+ 
+ $29.0
+
+ 
+ 
+ $29.0
+
+ 
+ 
+ 
+ 
+ Tribal Court Improvement Program — 
+ Competitive grants for tribal courts a 
+
+ 
+ 
+ $1.0
+
+ 
+ 
+ $1.0
+
+ 
+ 
+ $1.0
+
+ 
+ 
+ $1.0
+
+ 
+ 
+ $1.0
+
+ 
+ 
+ 
+ 
+ Monthly Caseworker Visits —
+Formula grants to states and territories
+
+ 
+ 
+ $19.0
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ $18.5
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ 
+ 
+ Regional Partnership Grants — 
+ Competitive grants to regional partnerships to improve outcomes for children affected by parental substance abuse
+
+ 
+ 
+ $19.0
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ $18.5
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ $18.6
+
+ 
+ 
+ 
+ 
+ Evaluation, research, training , and technical assistance —
+Competitive grants, contracts, or agreements
+
+ 
+ 
+ $7.7
+
+ 
+ 
+ $7.5
+
+ 
+ 
+ $7.5
+
+ 
+ 
+ $7.6
+
+ 
+ 
+ $7.6
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS).
+
+ Notes: For FY2013, both mandatory and discretionary PSSF funding was affected by sequestration. For FY2014 through FY2017, only the program's mandatory funding was subject to sequestration. Sequestration applied to each program sub-purpose, which means that the effect of sequestration (i.e., the percentage reduction) was spread across each of the PSSF programs and activities. 
+
+ a. Like other PSSF set-asides funded with mandatory dollars, the annual tribal Court Improvement set-aside amount ($1 million) was subject to sequestration in each of FY2013-FY2017. However, the effect of the sequestration (which produced funding levels ranging from a low of $927,000 to a high of $949,000 during those years) is not seen in this table because of rounding. 
+
+ 
+
+ 
+
+ Family Connection Grants
+
+ Section 427 of the Social Security Act authorizes Family Connection Grants. Congress last provided funding for these grants in FY2014. Family Connection Grants were used to support and evaluate four kinds of services, each intended to enable children in foster care, or at risk of entering care, to stay connected with their families, 26 including
+ kinship navigator programs , which assist kin caregivers in finding and using services to meet their own needs and the needs of the children they are serving; 
+
+ family finding , which uses intensive search methods to locate biological family members who may serve as a child's permanent family; 
+
+ family group decisionmaking , which involves holding meetings to enable family members to develop a plan for the care and protection of children who have come to the attention of the child welfare agency; and
+
+ residential family treatment , which enables parents to address substance abuse and mental health issues in a comprehensive treatment program while continuing to live with their children.
+ Across the life of this program, Family Connection grants were awarded to 49 grantees, including 11 public child welfare agencies (state, local, and tribal) and 38 private nonprofit agencies located in 23 states. 27 Projects supported with Family Connection Grant dollars were typically funded for three years, and grantees were required to provide nonfederal matching funds (between 25% and 50%, depending on the year of the grant) and to participate in coordinated evaluation activities. HHS also awarded a separate evaluation contract related to these grants. 28 
+
+ These grants were established as part of the Fostering Connections to Success and Improving Adoptions Act of 2008 ( P.L. 110-351 ) and were never funded via annual appropriations acts. Instead, P.L. 110-351 appropriated $15 million annually to support their initial five years of operation (FY2009-FY2013), and the Preventing Sex Trafficking and Strengthening Families Act ( P.L. 113-183 ) appropriated $15 million in FY2014 funding for these grants. 29 (See Table 5 .)
+
+ 
+ 
+ Table 5. Final Funding for Family Connection Grants
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Family Connection Grants
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Competitive grants to eligible entities and to support evaluation
+
+ 
+ 
+ $14.2
+
+ 
+ 
+ $15.0 a 
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note s : Funding for the grants was first appropriated via P.L. 110-351 and has never been included in annual appropriations acts. FY2013 funding shown reflects the final operating level after application of sequestration. 
+
+ a. FY2014 funding for this program was appropriated on September 29, 2014, by P.L. 113-183 , which was after the overall mandatory sequestration level had been determined by the Administration. Accordingly, sequestration did not apply to the FY2014 funds provided for this program. 
+
+ 
+
+ 
+
+ Child Welfare Research, Training, or Demonstration Projects
+
+ Section 426 of the Social Security Act, established in the early 1960s, authorizes HHS to make grants, or to enter into contracts or cooperative agreements, to support research or demonstration projects that have regional or national significance, advance the practice of child welfare, encourage the use of research-based experimental or special types of child welfare services, and advance training for child welfare workers (including through traineeships). Entities eligible to conduct this work include public or nonprofit institutions of higher education, public or nonprofit agencies that conduct research or child welfare-related activities, and state or local (public) child welfare agencies. HHS is granted broad authority to design and administer these grants, contracts, or cooperative agreements. 
+
+ HHS describes the "critical" uses of the Section 426 funding as follows: 30 
+ administration of awards to colleges and universities that provide stipends for education of child welfare professionals; 
+
+ delivery of a child welfare training curriculum on leadership and effective change management;
+
+ development of a comprehensive workforce framework; 
+
+ convening and providing leadership academies for state agency directors and middle managers, deans and directors of schools of social work, and online training for front-line supervisors; 
+
+ facilitating a national peer network of child welfare leaders focused on professional development of their workforce and strategic dissemination of effective and promising workforce practices. 31 
+ Beginning with FY2015, Congress has in each year stipulated that funds in this Section 426 account are available to support the National Survey of Child and Adolescent Well-Being (NSCAW). 32 For more information about this survey, see the NSCAW discussion below. 
+
+ Section 426 of the Social Security Act authorizes annual funding for research, demonstration, and training activities on a permanent (no year limit) basis at "such sums as Congress may determine necessary." Final funding provided under this authority in FY2013-FY2017 is shown in Table 6 below. 
+
+ 
+ 
+ Table 6. Final Funding for Child Welfare Research, Training, or Demonstration 
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Child Welfare Research, Training and Demonstration
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Competitive grants, contracts, and other arrangements to support child welfare workforce training and to advance practice of child welfare via research or demonstration
+
+ 
+ 
+ $24.4
+
+ 
+ 
+ $25.0
+
+ 
+ 
+ $16.0
+
+ 
+ 
+ $18.0 
+
+ 
+ 
+ $18.0
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS).
+
+ Note: The FY2013 funding shown reflects the final operating level after application of sequestration.
+
+ 
+
+ 
+
+ National Survey of Child and Adolescent Well-Being (NSCAW)
+
+ Section 429 of the Social Security Act requires HHS to conduct (directly or by contract) a nationally representative study of children who are at risk of child abuse or neglect, or are determined by the state to have been abused or neglected. In response to this 1996 legislative directive, NSCAW was launched. Two surveys have been conducted (in 1999 and again in 2008), gathering initial ("baseline") information on a national sample of approximately 6,000 children living in families investigated for child abuse and neglect along with follow-up information on these children and their families collected at intervals (up to five years) following the initial surveys. 33 HHS has begun work for a third NSCAW survey, which, following recruitment of participating agencies, is expected to begin initial data collection in late summer 2017. (This third survey, unlike the first two, is being supported with funds from the Child Welfare Research, Training, and Demonstration account, described in the preceding section. 34 )
+
+ The survey data collected via NSCAW are unique from other child welfare administrative data reported by state child welfare agencies to HHS. 35 NSCAW looks at a nationally representative sample of children in families investigated for child abuse and neglect—and without regard to whether child abuse or neglect was determined by a child protective services investigator to have occurred or whether a child entered foster care. Thus the survey provides a more complete portrait of the full spectrum of children and families served by child welfare agencies. Further, NSCAW gathers information from children, parents, and other caregivers, as well as teachers and caseworkers, to examine the socio-behavioral, education, health status, and other conditions of children and families served by child welfare agencies, and it uses a range of standardized questions ("instruments") to do this. Multiple reports, research briefs, and info-graphics have been produced for HHS from these survey data, 36 and many researchers have accessed the data for additional published analyses. 37 
+
+ Title IV-E of the Social Security Act
+
+ Title IV-E of the Social Security Act principally entitles states, tribes, and territories with an approved Title IV-E plan 38 to reimbursement of part of their costs of providing foster care, adoption assistance, or kinship guardianship assistance on behalf of eligible children. Each of the 50 states and the District of Columbia has an approved IV-E plan. Puerto Rico has long been the only territory with such a plan; however, effective with FY2017, the U.S. Virgin Islands also has received approval of a Title IV-E plan. 39 Additionally (as of November 2017), 10 tribal entities have an approved Title IV-E plan (see Appendix C ). 40 
+
+ Title IV-E also authorizes capped mandatory funding for support of services to children who are expected to leave foster care because they "age out" of care rather than because they are returned home or placed in a new permanent family, youth who have aged out of care, and youth who leave care at age 16 or older for adoption or legal guardianship. Authorized under the Chafee Foster Care Independence Program, any state, tribe, or territory with an approved Title IV-E plan is entitled to a part of this capped mandatory funding. 41 
+
+ Additionally, Title IV-E provides annual capped mandatory funding for technical assistance related to providing child welfare services to tribal children, and this includes competitive grants to tribes to support development of a Title IV-E plan. 
+
+ Finally, provisions included in Title IV-E also authorize discretionary funding for incentive payments to states and territories (with an approved Title IV-E plan) that increase adoptions and/or legal guardianships of children from foster care. 
+
+ Legislation authorizing these Title IV-E programs and activities is handled by the House Committee on Ways and Means and the Senate Committee on Finance.
+
+ Foster Care
+
+ When a child is found to be abused, neglected, or otherwise unsafe in his or her own home, the state may act to remove the child from that home and to place him or her in foster care. Foster care is a temporary living arrangement intended to ensure a child's safety and well-being until a permanent home can be reestablished or newly established for the child. Under the Title IV-E program, the public child welfare agency must work to ensure that each child who enters foster care is safely returned to his/her parents, or—if this is determined not possible or appropriate (by a court)—to find a new permanent home for the child via adoption, legal guardianship, or placement with a fit and willing relative. 
+
+ The number of children in foster care declined from a reported high of 567,000 on the last day of FY1999 to 397,000 on the last day of FY2012. However, that number has trended up since then, reaching close to 437,000 children as of the last day of FY2016. 42 
+
+ Funding Available for Costs of Providing Foster Care to Eligible Children
+
+ Each state, tribe, or territory with an approved Title IV-E plan is entitled to partial federal reimbursement for every eligible cost related to providing foster care to eligible children. Title IV-E eligible criteria are spelled out in law and regulation. 43 
+
+ Eligible Children
+
+ Nationally, there were more than 437,000 children in foster care on the last day of FY2016, and during that same fiscal year, more than 166,000 children received Title IV-E foster care maintenance payments in an average month. 44 These figures suggest that considerably less than half of all children in foster care met federal Title IV-E foster care eligibility criteria. 45 In general, those criteria 
+ stipulate that the child must be removed from a home with very low income (i.e., 50% or less of federal poverty level in about three-quarters of the states); 46 
+
+ require that the removal must have been accomplished through a judicial finding that the home was "contrary to the welfare" of the child, 47 or through a voluntary placement agreement entered into by the child's parent/guardian and the state child welfare agency;
+
+ provide that a child must be living in a licensed foster family home or a "child care institution;" and 
+
+ require the child to be under the age of 18 or, if the state, tribe, or territory has included assistance to older youth in its IV-E plan, under the age of 19, 20, or 21 (as elected by the state). 48 
+ As of April 2017, 29 jurisdictions (including 23 states, the District of Columbia, and 5 tribes) have approval to provide Title IV-E assistance for youth beyond their 18 th birthday. (See Appendix D for a list.) 
+
+ Eligible Costs
+
+ Eligible Title IV-E costs include
+ spending on foster care maintenance payments (for the eligible child's "room and board");
+
+ caseworker time to perform required activities on behalf of eligible children in foster care or children at imminent risk of entering foster care (e.g., finding a foster care placement for a child and planning services needed to ensure a child does not need to enter care, is reunited with his or her parents, has a new permanent home, or is otherwise prepared to leave foster care); 
+
+ program-related data system development and operation;
+
+ program eligibility determinations;
+
+ training and recruitment of foster care providers for eligible children and training for child welfare workers and certain professional partners working with eligible children; 
+
+ implementing procedures related to identifying child-welfare-involved children and youth who are victims of (or at risk of) sex trafficking, documenting this, determining any services needed, and reporting information regarding victims of sex trafficking to law enforcement agencies; 49 and 
+
+ other program administration costs (related to eligible children in foster care). 
+ Federal support for these Title IV-E program costs is 75% of a state's IV-E program training costs, 50% of all other eligible program administration costs, and ranges between 50% and 83% of eligible foster care maintenance payment costs (the percentage is redetermined annually and varies by state, with higher federal support going to states with lower per capita income). 50 
+
+ Waivers
+
+ Currently 28 jurisdictions (26 states, the District of Columbia, and the Port Gamble S'Klallam Tribe) have approved child welfare demonstration projects (i.e., "IV-E waivers"). Under the terms and conditions of their specific waiver agreements, each of these jurisdictions is permitted to use Title IV-E foster care funds to provide services or assistance to children (and their families)—even if those children or those services or assistance would not normally be considered eligible. Under current law, HHS is not authorized to grant any new child welfare waivers, and no state may operate a waiver project after September 30, 2019. 51 ( Appendix E shows jurisdictions with current Title IV-E waiver projects, including implementation and current end dates.) 
+
+ First authorized by Congress in 1994, the goal of permitting waivers of specific Title IV-E requirements is to allow states to demonstrate alternative and innovative practices that achieve federal child welfare policy goals in a manner that is cost neutral to the federal Treasury. Each project has a specific approval period (usually five years), must be determined to cost the federal government no more in Title IV-E support than it would without the waiver project, and must be independently evaluated. 
+
+ Title IV-E waiver projects vary significantly in geographic and program scope. Some operate (or plan to) on a statewide basis, others are limited to specific regions or counties in the state. The interventions may focus on different age groups (e.g., children age 0-5 years; children ages 12-17) and different service needs or circumstances (e.g., children entering care for the first time; children at risk of entering care; children transitioning from group care to home; children with substance-abusing parents). 52 At the same time, most of the approved waiver projects seek to use Title IV-E funds to demonstrate services or support that achieve one or more of the following:
+ prevent child abuse or neglect or the recurrence of child abuse or neglect; 
+
+ prevent the need for children to enter (or reenter) foster care; and/or 
+
+ increase the speed and frequency with which children who are in foster care find permanency (through reuniting with family or placement in a new permanent adoptive or guardianship home). 
+ Additional focus, in a smaller number of projects, addresses other issues, such as preventing or reducing the use of group ("congregate") care for children in foster care; addressing behavioral health needs of children; addressing needs of caregivers with substance use disorders; and reducing placement instability for children in foster care. 53 
+
+ Before approving a Title IV-E waiver project, HHS, together with the OMB, must determine a method to ensure that the state will not receive more funding under the approved waiver than it would have received in the absence of the waiver. For most current waiver projects, this "cost neutrality" determination is based on a prenegotiated capped allocation of a specific part of their federal Title IV-E foster care funding. In some of those states, the cap applied to funding across the entire state and for nearly all foster care costs; in others the cap applied only to one or more counties/cities or for specific kinds of costs (e.g., cost of congregate care). In places without a cap, cost neutrality might rely on providing the same average per child cost for "usual care" as is provided for "treatment" care. 
+
+ While states are able to use waiver funds for more activities and to serve different populations than would be allowed generally under the Title IV-E program, they also must continue—out of this same funding—to provide any needed foster care services and to meet all applicable federal child protections for those children (e.g., case planning and review). 54 Additionally, to receive funding under the waiver, each jurisdiction must continue to provide the nonfederal (state) share of program funding, which varies by type of program cost and may also vary by state (based on the amount of maintenance payment spending included in the cap). The state's share is always 50% for program administrative costs that are included in the capped funding (e.g., spending on case planning and management) and may not be more than 50% nor less than 17% for maintenance payments costs that are included in the cap. 
+
+ A survey of state child welfare spending in state FY2014 found that among 18 states that reported spending under the waiver project of more than $1 billion, most of this funding continued to be used to provide foster care to children who were eligible for Title IV-E foster care (58%, $614 million) or was spent on those same foster care costs for children in foster care who did not meet Title IV-E eligibility (32%, $339 million). The remainder was spent primarily on other services and activities, whether for Title IV-E eligible or ineligible children (9%, $75 million) and for program development or evaluation (1%, $26 million). 55 
+
+ Foster Care Funding Authorized
+
+ Title IV-E entitlement (or mandatory) funding for foster care is authorized on a permanent basis (no year limit) and is provided in annual appropriations acts. Congress typically provides the amount of Title IV-E foster care funding (or "budget authority") that the Administration estimates will be necessary for it to provide state or other Title IV-E agencies with the promised level of federal reimbursement for all of their eligible Title IV-E foster care costs under current law. As of the mid-session review (released July 2017), HHS estimates Title IV-E foster care funding needed for FY2017 to be $5.091 billion. For federal Title IV-E funds obligated by HHS in FY2013-FY2016 and estimated budget authority needed for FY2017, see Table 7 . 
+
+ Adoption Assistance 
+
+ Under Title IV-E of the Social Security Act, states, territories, or tribes with an approved Title IV-E plan are required to enter into an adoption assistance agreement with the adoptive parents of any child who is determined by the Title IV-E agency to have "special needs." An adoption assistance agreement must specify the nature and amount of any payments, services, and assistance to be provided. 
+
+ To determine that a child has "special needs," that public agency must find that 
+ the child cannot or should not be returned to his/her parents;
+
+ reasonable but unsuccessful efforts to place the child for adoption without assistance have been made (unless those efforts would not be in the child's best interest); and 
+
+ the child has a specific condition or factor making it unlikely that he/she would be adopted without provision of adoption assistance or medical assistance.
+ Each state, territory, or tribe may establish its own "special needs" condition or factors and, as suggested in federal law, they frequently reference the child's age; membership in a sibling group; physical, mental, or emotional disability/disorder; and/or membership in a racial/ethnic minority. Nearly all special needs adoptees were previously in foster care. 56 Nationally, states reported that some 82% of children adopted from foster care in FY2015 were determined by the state to have special needs, and the primary special needs identified were membership in a sibling group (32%); medical condition or physical, mental, or emotional disability (21%); "other—Title IV-E agency defined factor" (21%); age (16%); or race/ethnicity (9%). 57 
+
+ Eligibility for Title IV-E Adoption Assistance for Special Needs Adoptees
+
+ For any child with special needs, federal reimbursement is available to states for a part of the cost of paying the adoptive parent's nonrecurring adoption expenses (i.e., one-time costs related to legally finalizing the adoptions). 58 Federal reimbursement is also available for a part of the cost of providing ongoing (monthly) subsidies to adoptive parents on behalf of children with special needs. Under current law, some children with special needs are required to meet additional income and other criteria to be eligible for this ongoing assistance, but those additional rules are being phased out, primarily based on age of the special needs child in the fiscal year the adoption assistance agreement is finalized. 59 During FY2016, ongoing monthly Title IV-E adoption assistance payments were paid on behalf of close to 456,700 children on an average monthly basis. 60 
+
+ States, territories, or tribes with a Title IV-E plan approved by HHS may seek federal reimbursement for a part of the cost of making payments agreed to under Title IV-E adoption assistance agreements and for related program administration costs, including training. As with Title IV-E foster care funding, Title IV-E adoption assistance funding is authorized on a permanent (no year limit) basis, and Congress typically provides the amount of annual funding for this open-ended entitlement that HHS estimates will be necessary to reimburse states for all eligible program costs. As of the mid-session review (released July 2017), HHS estimated it would need $2.658 billion in federal Title IV-E adoption assistance budget authority for FY2017. For federal Title IV-E adoption assistance funds obligated in FY2013-FY2016 and estimated budget authority need for FY2017, see Table 7 .
+
+ Kinship Guardianship Assistance
+
+ Beginning in FY2009, states or territories (and, as of FY2010, tribes) with an approved Title IV-E plan were permitted (but not required) to include provision of kinship guardianship assistance in those Title IV-E plans. As of June 2017, 44 jurisdictions, including 35 of the 50 states, the District of Columbia, and 8 tribes, had incorporated this kind of assistance in their Title IV-E plans. (For a list of these jurisdictions, see Appendix F .) Accordingly, these states and tribes may seek federal reimbursement for a part of the cost of providing ongoing kinship guardianship assistance payments on behalf of every eligible child. 
+
+ To be eligible for Title IV-E kinship guardianship, a child must have previously been in foster care and must have been eligible to receive Title IV-E foster care maintenance payments (while living in the home of the prospective legal relative guardian). 61 During FY2016, ongoing monthly Title IV-E kinship guardianship assistance payments were paid on behalf of some 25,500 children on an average monthly basis. 62 
+
+ As with other Title IV-E program components, funding is authorized on a permanent basis (no year limit). Jurisdictions with an approved Title IV-E plan that includes the kinship guardianship assistance option are entitled to reimbursement for a part of the program costs, including guardianship assistance payments paid to legal relative guardians on behalf of eligible children, and for related program administration, including training. 63 As of the mid-session review (released July 2017), HHS estimates that FY2017 federal budget authority needed for Title IV-E kinship guardianship assistance will be $136 million. For federal Title IV-E kinship guardianship funds obligated in FY2013-FY2016 and estimated budget authority needed for FY2017, see Table 7 . 
+
+ Obligations of Funds by Title IV-E Program Component
+
+ Title IV-E funding is described as an "open-ended entitlement" because the law (Section 474 of the Social Security Act) provides that a state is entitled to reimbursement for a particular share (or percentage) of every eligible program cost incurred by a state or tribe operating a Title IV-E program. 64 To meet this commitment in each annual appropriations act, Congress provides "definite budget authority" (a certain amount of funds) that enables HHS to reimburse states, territories, and tribes for their eligible Title IV-E costs. 
+
+ The amount needed for this purpose is estimated in the annual budget request of the President, and this is typically the amount of definite budget authority provided by Congress. In any year that Congress authorizes more funding than needed to make these reimbursements, the extra funding authority will eventually lapse (no longer be available from the federal Treasury). Alternatively, if the definite budget authority provided is not enough to provide the federal share (reimbursement) of the eligible Title IV-E program costs submitted by states, territories, or tribes, the annual appropriations acts typically also include an "indefinite budget authority." This authority allows HHS to access additional funds (within a specific time frame) to meet the statutory commitment to reimburse a part of every eligible program cost. 65 
+
+ Table 7 shows the amount of funding (actual or estimated) obligated by HHS in each of FY2013-FY2017 for Title IV-E foster care, adoption assistance, and kinship guardianship assistance. 
+
+ 
+ 
+ Table 7. Funding Under the Title IV-E Program for Foster Care and Permanency
+
+ (nominal dollars in millions; amounts shown are obligations)
+
+ 
+
+ 
+ 
+ 
+ Title IV-E Program
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTA L 
+
+ 
+ 
+ $6,487 
+
+ 
+ 
+ $7,286 
+
+ 
+ 
+ $7,200 
+
+ 
+ 
+ $7,522 
+
+ 
+ 
+ $7,817 
+
+ 
+ 
+ 
+ 
+ Foster Care
+
+ 
+ 
+ $4,132
+
+ 
+ 
+ $4,746
+
+ 
+ 
+ $4,581
+
+ 
+ 
+ $4,815
+
+ 
+ 
+ $5,091
+
+ 
+ 
+ 
+ 
+ Adoption Assistance
+
+ 
+ 
+ $2,278
+
+ 
+ 
+ $2,450
+
+ 
+ 
+ $2,510
+
+ 
+ 
+ $2,587
+
+ 
+ 
+ $2,590
+
+ 
+ 
+ 
+ 
+ Kinship Guardianship Assistance
+
+ 
+ 
+ $77
+
+ 
+ 
+ $90
+
+ 
+ 
+ $109
+
+ 
+ 
+ $121
+
+ 
+ 
+ $136
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). Parts may not sum to total due to rounding.
+
+ Notes: The mandatory funding provided in this program is exempt from sequestration. However, any funding in the account for federal "administrative expenses" is subject to sequestration. For FY2016 and FY2017, this resulted in sequestration of between $1 and $2 million in Title IV-E foster care funds.
+
+ The funding shown in this table for FY2017 is based on budget obligations estimated as part of the mid-session budget review (finalized in July 2017) and therefore differs from numbers shown in CRS Report R44863, Child Welfare Funding in Brief: FY2017 Final Funding and the President's FY2018 Request . (See Table 1 , table note "a" for more explanation.) For FY2013-FY2016, the numbers are based on the program "obligations" or budget authority estimates included in the most recent President's annual budget request with the relevant fiscal year data). Previous versions of this table showed definite budget authority for each Title IV-E program component as included in annual appropriations acts, and those amounts varied from the obligation amounts shown here.
+
+ a. This total is for the open-ended funding components of the Title IV-E program only. From a formal budget account (and statutory) perspective, additional components are the mandatory portion of the John H. Chafee Foster Care Independence Program (CFCIP; i.e., the general program) and the funding for Tribal Title IV-E plan Development and Technical Assistance. Each is discussed in succeeding sections. 
+
+ 
+
+ 
+
+ Tribal Title IV-E Plan Development and Technical Assistance
+
+ Section 476(c) of the Social Security Act authorizes HHS to make grants to tribes, valued at up to $300,000, to assist them with the cost of preparing a Title IV-E plan for HHS approval. Among other things, this may include costs related to the development of a tribal data collection system, a cost allocation methodology (which is needed to seek federal reimbursement for any Title IV-E cost that is not an assistance payment), and agency and tribal court procedures necessary to meet the case review system requirements under the Title IV-E program. The grants are to be provided only to tribes that intend to submit a Title IV-E plan for HHS approval within 24 months. HHS awards these grants annually, on a competitive basis. Through the last day of FY2017 (September 30, 2017), 34 tribes (or tribal consortia) had received a plan development grant, 66 and, as of November 2017, 10 tribes (or consortia) had approved Title IV-E plans (see Appendix C ).
+
+ Additionally, Section 476(c) requires HHS to provide "information, advice, educational materials, and technical assistance" to tribes regarding providing services and assistance to tribal children under the child welfare programs authorized in Title IV-B and Title IV-E of the Social Security Act. This technical assistance must also be available for states regarding working with tribes to develop cooperative agreements (under which some IV-E funding received by the state is provided to the tribe) as well as consulting with tribes on the state's plan to comply with the Indian Child Welfare Act (ICWA). As part of responding to this requirement, HHS is currently funding the National Child Welfare Capacity Building Center for Tribes. 67 
+
+ The authorization for tribal technical assistance and IV-E plan development grants was added to the Social Security Act by the Fostering Connections to Success and Increasing Adoptions Act of 2008 ( P.L. 110-351 ). The law provides a permanent (no year limit) annual appropriation of $3 million.
+
+ 
+ 
+ Table 8. Final Funding for Tribal Title IV-E Plan Development and Technical Assistance (TA)
+
+ (nominal dollar amounts in millions)
+
+ 
+
+ 
+ 
+ 
+ Tribal IV-E Plan Development and TA
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Competitive grant funding for tribal IV-E plan development and technical assistance
+
+ 
+ 
+ $2.98
+
+ 
+ 
+ $2.96
+
+ 
+ 
+ $2.96
+
+ 
+ 
+ $2.96
+
+ 
+ 
+ $2.96
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note: For purposes of sequestration, this funding is included in the "exempt" Title IV-E account. However, funding in each of FY2013-FY2017 is a little less than the previously appropriated $3 million due to the effect of sequestration on the part of this funding used for federal administrative purposes.
+
+ 
+
+ 
+
+ Chafee Foster Care Independence Program
+
+ The John H. Chafee Foster Care Independence Program (CFCIP) (§477 of the Social Security Act) authorizes funding for states, territories, and tribes to provide services to help youth make a successful transition from foster care to adulthood. 68 Under the program, states are expected to identify children or youth likely to remain in foster care until their 18 th birthday to ensure that they have regular and ongoing opportunities to engage in age- or developmentally appropriate activities and to help prepare them for self-sufficiency. States are also expected to provide financial, housing, counseling, education, employment, and other appropriate supports to former foster youth 18, 19, or 20 years of age and to promote and support mentoring or other connections with dedicated adults. CFCIP may also support services to youth who, after reaching 16 years of age, leave foster care for adoption or legal guardianship. States must ensure that youth served under CFCIP are actively involved in decisions about the services they receive. 
+
+ Beginning with FY2011, the 50 states, the District of Columbia, and Puerto Rico report to HHS on "independent living services" that were paid for by the agency that administers the CFCIP program. During FY2013, close to 100,000 youth (ages 14-26 years) received at least one such service, and many of those youth (58%) received three or more services. The most common services were academic support, career preparation, and education about housing and home management. 69 
+
+ Funding for the Chafee program is authorized on a permanent basis (no year limit) as a capped entitlement to states and territories, provided they have an approved Title IV-E plan. Tribes may also receive direct federal support under this program, with or without an approved Title IV-E plan. 70 The authorized amount of funds, $140 million, is provided in annual appropriations bills. (Beginning with FY2020, this annual amount is slated to rise to $143 million.) 71 The mandatory CFCIP funds are considered a part of the Title IV-E program and, apart from a small portion used for federal program administration, are not subject to sequestration. (See Table 9 .) 
+
+ Chafee Educational and Training Vouchers (ETVs)
+
+ An additional purpose of the CFCIP is to provide Educational and Training Vouchers (ETVs) (§477(i) of the Social Security Act) to defray the cost of postsecondary education or training for any youth who is eligible for CFCIP general services. ETVs may be valued at up to $5,000 a year and may be used for the "cost of attendance" (including tuition, fees, books, room and board, supplies, and other items) at an "institution of higher education" (including public or private, nonprofit two- and four-year colleges and universities, as well as proprietary or for-profit schools offering technical training programs, among others). 72 Discretionary funding for ETVs is authorized on a permanent (no year limit) basis, and program appropriations are distributed based on a state's relative share of children in foster care. Final funding provided for CFCIP, including Educational and Training Vouchers for each of FY2013-FY2017, is shown in Table 9 . 
+
+ Funding and Distribution for the CFCIP Program, Including ETVs
+
+ HHS is required to reserve 1.5% of the funding appropriated for CFCIP, including ETV funding, to support evaluations, technical assistance, performance measurement, and data collection related to the program. The remaining general program funds are distributed to states and territories with an approved Title IV-E plan based on their relative share of the national population of children in foster care. However, no state or territory may receive an allotment of less than $500,000 or the amount it received under CFCIP's predecessor program (in FY1998)—whichever is greater. Chafee ETV funds are distributed based solely on the state's relative share of the national population of children in foster care. Additionally, to receive any CFCIP or ETV funding, states must give certain assurances to HHS related to their operation of the program. Finally, a state must provide nonfederal resources of no less than 20% of total spending under the program to receive its full CFCIP and ETV allotments.
+
+ 
+ 
+ Table 9. Final Funding for the Chafee Foster Care Independence Program (CFCIP)
+
+ (nominal dollars in millions; parts do not sum to total because of rounding)
+
+ 
+
+ 
+ 
+ 
+ Chafee Foster Care Independence Program
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL 
+
+ 
+ 
+ $182.3 
+
+ 
+ 
+ $183.2 
+
+ 
+ 
+ $183.2 
+
+ 
+ 
+ $183.2 
+
+ 
+ 
+ $183.2 
+
+ 
+ 
+ 
+ 
+ General Program (mandatory) 
+
+ 
+ 
+ $140.0
+
+ 
+ 
+ $140.0
+
+ 
+ 
+ $140.0
+
+ 
+ 
+ $140.0
+
+ 
+ 
+ $140.0
+
+ 
+ 
+ 
+ 
+ Educational and Training Vouchers (ETV) (discretionary) 
+
+ 
+ 
+ $42.3
+
+ 
+ 
+ $43.3
+
+ 
+ 
+ $43.3
+
+ 
+ 
+ $43.3
+
+ 
+ 
+ $43.3
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by Congressional Research Service (CRS). 
+
+ Notes: CFCIP general program (mandatory) funding is considered a part of the Title IV-E program account and so is largely exempt from sequestration. However, a small amount of program funds is used for federal program administration and accordingly, sequestration reduced mandatory general CFCIP funding by $1,000 in FY2013 and between $37,000 and $40,000 in each of FY2014-FY2017. Chafee ETV funding under the program is discretionary and nonexempt; as such it was subject to sequestration in FY2013 and funding shown for the ETV program in that year reflects the final operating level after application of sequestration.
+
+ 
+
+ 
+
+ Adoption and Legal Guardianship Incentive Payments
+
+ Adoption Incentive Payments were established in 1997, as part of a package of policy changes included in the Adoption and Safe Families Act, (ASFA, P.L. 105-89 ) that were intended to ensure children's safe and expeditious exit from foster care to permanent homes, including through adoption. Since ASFA's enactment in 1997, the annual number of children leaving foster care for adoption has risen from roughly 30,000 to more than 50,000, and the average length of time it took states to complete the adoption of a child from foster care declined by close to one year (from about four years to less than three). 73 In FY2016, state child welfare agencies helped to complete more than 57,000 adoptions. 
+
+ The most recent reauthorization of the incentives, enacted in 2014 ( P.L. 113-183 ), added recognition of state success at finding permanent families for children through legal guardianship and renamed the program as Adoption and Legal Guardianship Incentive Payments. Close to 24,000 children left foster care for guardianship during FY2016. 
+
+ States do not earn an incentive payment for every adoption or guardianship completed. Instead, they earn incentives only when they increase the rate (or percentage) of children in their state who leave foster care for new and permanent families. Specifically, under the incentive structure established with the 2014 reauthorization, they may earn the following amounts: 
+ $5,000 for each adoption of a foster child (any age) that results from the increased rate; 
+
+ $4,000 for legal guardianship established for a foster child (any age) that results from the increased rate; 
+
+ $7,500 for each adoption or guardianship for foster children ages 9 to 13 that results from the increased rate; and 
+
+ $10,000 for each adoption or guardianship for foster children age 14 or older, that results from the increased rate. 74 
+ A state is found to have an increased rate if during the fiscal year the percentage of children leaving foster care in one or more of these categories exceeds the comparable percentage for either the most recent previous year or the average percentage for the three most recent previous years. 75 
+
+ States may spend adoption incentive payments earned toward any services authorized under the child welfare programs in Title IV-B or Title IV-E of the Social Security Act and, as of FY2014, they have a full 36 months from the month the award payment is made. 76 
+
+ In recent years, the amount of incentive payments earned by states in a single year (between $40 million and $55 million) has consistently outpaced the annual funding appropriated to pay those incentives ($38 million). Accordingly, to ensure states received the full incentives earned, HHS has awarded the payments across two years—using a part of the appropriations from both years. However, unless the final FY2018 funding provided for these payments is appropriated at a level higher than the $38 million appropriated in each recent year, even this two-year approach will not enable HHS to pay states the full $55 million in incentive payments they earned in FY2016. 
+
+ In September 2017, when it announced the FY2016 awards, HHS had just $5 million of the FY2017 appropriation incentive payments available to make these awards (because in June 2017 it used $23 million of the FY2017 appropriation to make states whole for their FY2015 incentive awards). Accordingly, and as it had done in past years, HHS made initial, prorated incentive payments with those funds—meaning each state received roughly 10% of the incentive payment amount it earned for FY2016. However, that leaves the outstanding balance to be paid out of the FY2018 appropriation at $50 million, or $12 million more than the $38 million that has been provided annually for the incentive payments in recent years. (See Appendix G for incentive awards earned by category and state for FY2016.) 
+
+ Although the discretionary funding authorization for Adoption and Legal Guardianship Incentive payments ($43 million/year) expired on September 30, 2016, Congress chose to continue the incentive program and provided FY2017 funding for them as part of P.L. 115-31 . See Table 10 for final funding in each of FY2013-FY2017. 
+
+ 
+ 
+ Table 10. Final Funding for Adoption and Legal Guardianship Incentive Payments
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Incentive Payments
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Funds to make incentive payments
+
+ 
+ 
+ $37.2
+
+ 
+ 
+ $37.9
+
+ 
+ 
+ $37.9
+
+ 
+ 
+ $37.9
+
+ 
+ 
+ $37.9
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note s : The FY2013 funding shown reflects the final operating level after application of sequestration. The name of this program was changed to include "legal guardianship" effective October 1, 2014. 
+
+ 
+
+ 
+
+ Child Abuse Prevention and Treatment Act (CAPTA)
+
+ CAPTA was enacted in 1974 ( P.L. 93-247 ) at a time of growing awareness and concern about abuse of children in their own homes. It has been reauthorized many times since then, most recently by the CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ). CAPTA authorizes formula grant funding to states to improve their child protective services (state grants); competitively awarded funds to support research, technical assistance, and demonstration projects related to prevention, assessment, and treatment of child abuse and neglect (discretionary activities); and funding to all states for support of community-based activities to prevent child abuse and neglect (community-based grants). 77 Further, it incorporates program authority for what are commonly referred to as "Children's Justice Act grants." Legislation authorizing these programs and activities in CAPTA is handled by the House Education and the Workforce Committee and the Senate Health, Education, Labor and Pensions (HELP) Committee.
+
+ CAPTA State Grants
+
+ The focus of CAPTA is on providing a primarily social service (rather than a criminal justice) response to abuse or neglect of children carried out by their parents or other caretakers . The Justice for Victims of Trafficking Act of 2015 ( P.L. 114-22 ) amended CAPTA to require (as of May 29, 2017) that children identified as victims of sex trafficking (regardless of whether the trafficker is considered their parent or "caretaker") must also be counted as victims of child abuse and provided access to social services. 78 In FY2015, state and local child protective services (CPS) agencies received 4.0 million calls or other referrals alleging abuse or neglect involving an estimated 7.2 million children. After screening those referrals they determined CPS response (investigation or assessment) was warranted for 2.2 million of the referrals, involving an estimated 3.4 million children. 79 
+
+ Under CAPTA State Grants (Section106 of CAPTA), each state and territory receives funds to make improvements to its CPS system. In recent years, funding provided via these state grants has offered less than $12 for each CPS investigation or assessment of child abuse or neglect carried out by states (on a national basis). 80 Therefore, the bulk of the cost to receive and respond to child abuse or neglect allegations is assumed to be borne by states and localities out of their own treasuries or using other federal funding (e.g., Social Services Block Grant).
+
+ The CAPTA statute lists 14 potential areas for CPS program improvement (or uses of funds). A little more than two-thirds of the states (67%) reported their intention to use their CAPTA state grant funds to improve the intake, assessment, screening, and investigation of reports of child abuse or neglect. Considerably more than half (58%) intended to use the funds to develop, improve, and implement risk and safety assessment tools and protocols, including use of differential response, and a similar share (56%) intended to use the funds to improve case management, ongoing case monitoring, and delivery of services and treatment provided to families. 81 
+
+ To receive CAPTA state grant funds each state, including the District of Columbia and Puerto Rico, must assure HHS that it has 
+ a statewide system in place to receive and screen reports of child abuse or neglect and to provide appropriate responses that ensure children's safety, including developing a plan of safe care for infants brought to the attention of CPS (by health care providers) as substance-exposed; 
+
+ state laws that mandate specific individuals to make reports of known or suspected child abuse or neglect and provide immunity from prosecution for individuals who make these reports in good faith;
+
+ a technology system that allows the state to track reports of child abuse and neglect (from intake to final disposition); and
+
+ statewide procedures that, among other things, maintain the confidentiality of child abuse and neglect records; offer training to CPS workers; provide an appropriately trained guardian ad litem or advocate for each child abuse or neglect victim involved in judicial proceedings; and provide for cooperation between state law enforcement agencies, appropriate state human services agencies, and courts in the investigation, assessment, prosecution, and treatment of child abuse and neglect. 
+ In addition, states, including the District of Columbia and Puerto Rico, must establish and support Citizen Review Panels to evaluate the effectiveness of their CPS policies and practices and they must, "to the maximum extent practicable," submit annual data to HHS regarding child abuse and neglect in their state. 82 
+
+ Selected Amendments in the 2010 CAPTA Reauthorization and Other Subsequent Changes
+
+ The most recent reauthorization of funding for CAPTA state grants occurred in late 2010. That law ( P.L. 111-320 ) also made some amendments to the CAPTA state grant programs. More recently, the Justice for Victims of Trafficking Act of 2015 ( P.L. 114-22 ) and the Comprehensive Addiction and Recovery Act of 2016 (CARA, P.L. 114-198 ) also amended the program.
+
+ CAPTA Reauthorization Act of 2010
+
+ The CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ), which extended CAPTA funding authorization through FY2015, also made other changes to the law. Among these, it required every state to
+ have a law regarding who is mandated to report known or suspected child abuse and neglect; 83 
+
+ describe how it uses "differential response," to vary how it interacts with families for whom a report of child abuse or neglect has been made;
+
+ assure that it has a "technology system" capable of tracking child abuse and neglect cases; 
+
+ ensure it does not require a child to be reunited with a parent who has subjected the child to sexual abuse and/or who is required to register as a sex offender; and 
+
+ report information to HHS (to the maximum extent practicable) regarding the demographics and education/training of its CPS workforce and the states own established policies regarding education/training CPS workers as well as caseload standards for CPS workers and their supervisors.
+ The 2010 law also called for collaboration between CPS agencies and agencies providing services to families including victims of both adult domestic violence and child abuse, and made other changes to the act. 84 
+
+ Justice for Victims of Trafficking Act of 2015
+
+ Effective May 29, 2017, the Justice for Victims of Trafficking Act ( P.L. 114-22 ) requires a state to assure (as part of its CAPTA state plan) that it has the following in place:
+ procedures for the identification and assessment of all reports involving known or suspected child victims of sex trafficking; and 
+
+ provisions relating to training CPS workers to do this work and to provide services to victims of sex trafficking, including through coordination with other social service agencies. 85 
+ According to HHS, 43 states, the District of Columbia, and Puerto Rico had submitted signed assurances that they were in compliance with these trafficking-related provisions as of mid-June 2017. Assurances from three additional states (California, Hawaii, and Washington), were pending and expected to be submitted shortly. For the remaining four states (Arizona, Nevada, South Carolina, and West Virginia), the Children's Bureau was continuing to determine the status of implementation. It planned to require development of a "program improvement plan," if this was determined necessary for a state to reach compliance. 86 The 2015 law also requires states, to the maximum extent practicable, to report to HHS the number of children determined to be victims of sex trafficking. HHS plans to begin collecting these data from states beginning in FY2018. 87 
+
+ Comprehensive Addiction and Recovery Act of 2016 (CARA)
+
+ For more than a decade, each state receiving CAPTA basic grant funding has been required to have statewide policies mandating that health care providers notify CPS when an infant shows signs of prenatal exposure to, or withdrawal symptoms from, illegal drugs. Additionally, they have been required to develop a safe plan of care for any such infant. 88 CARA ( P.L. 114-198 ) built on this prior policy to require this notice be made without regard to whether the drug was illegal or legal and describes a required plan of safe care as one addressing both the health and well-being needs of the child and the substance abuse treatment needs of the child's parent/caregiver. Additionally, it requires states to report to HHS (to the extent possible) on the numbers of children identified under these provisions, those for whom a plan of safe care was developed, and those for whom referrals to services were made. (HHS plans to begin collecting these data from states beginning in FY2018.) 
+
+ CARA also calls on states to monitor their own compliance with the CARA provisions and provides for heightened federal monitoring of state compliance with this requirement. 89 Each state was required to detail its efforts to comply with these CARA provisions in a report that was submitted to HHS ACF regional offices by June 30, 2017. 90 States unable to ensure compliance with the new requirements were able to enter into a "program improvement plan" (PIP) designed to allow them to meet the requirements. As of December 2017, 23 states had entered into a PIP for this purpose. 91 
+
+ Funding and Distribution 
+
+ The CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ) extended annual discretionary funding for these grants through FY2015 (i.e., until September 30, 2015). Nonetheless, Congress chose to provide discretionary funding for these grants in FY2016 and again in FY2017. Each state and territory receives a base allotment of $50,000, and the remaining funds are distributed among the states and territories based on their relative share of the child (under age 18) population. For FY2015, the median CAPTA state grant award was $346,000, and among the 50 states, the grants ranged from a low of $87,000 (VT) to a high of $2.8 million (CA). 
+
+ To address low CAPTA grant amounts in states with small child populations, the 2010 reauthorization act added "minimum allotment" provisions. Under these provisions, no state is to receive an annual CAPTA grant of less than $100,000, provided overall funding appropriated for the grants was at least $27,535,000. This funding level trigger, which was designated at $1 million above the level Congress provided for the grants in FY2009, has not been reached. Funding has instead decreased for the grants, and therefore no change in the distribution of CAPTA state grant funding has been made. 92 Final funding for CAPTA state grants in each of FY2013-FY2017 is shown in Table 11 .
+
+ CAPTA Discretionary Activities
+
+ With the enactment of CAPTA, Congress sought to create a federal focal point for efforts to prevent, identify, and treat child abuse and neglect. Funding for CAPTA discretionary activities is used to support research and demonstration projects, and to collect and disseminate data and information. These activities are intended to improve understanding and practice with regard to preventing, identifying and treating child abuse and neglect. 
+
+ Under current law, HHS is required to maintain a national clearinghouse concerning child abuse and neglect that gathers and disseminates information on best practices and effective programs that prevent and/or respond to child abuse; provides technical assistance to state and local public and private agencies related to preventing and responding to child abuse and neglect; and collects and annually publishes data on child maltreatment. HHS is further required to fund field-initiated and interdisciplinary research related to protecting children from abuse and neglect and improving their well-being and to support the study of the national incidence of child abuse and neglect. Current law also permits HHS to fund demonstration projects or grants on a range of suggested topics (many related to training CPS staff and other relevant individuals). Additionally, HHS is permitted to establish an office on child abuse and neglect for the purpose of carrying out CAPTA and to ensure inter- and intra-departmental coordination of activities related to child abuse and neglect. 93 The Office of Child Abuse and Neglect (OCAN), within the Children's Bureau at HHS, carries out CAPTA and works to coordinate child abuse prevention and treatment activities within HHS and across federal agencies, including through its leadership of the Federal Interagency Work Group on Child Abuse and Neglect. 94 The OCAN uses CAPTA discretionary funds to support inclusion of child abuse and neglect-related information on the online portal, Child Welfare Information Gateway ( http://www.childwelfare.gov ), collection of state data via the National Child Abuse and Neglect Data System (NCANDS), and publication of annual reports ( Child Maltreatment ) based on those data. 95 
+
+ Funding provided for CAPTA Discretionary Activities also currently supports efforts to build the capacity of public child welfare agency workers (and the public or private agencies they work with) to carry out and continuously improve their work; planning grants for developing a model intervention for youth with child welfare involvement who are at-risk of homelessness; and partnerships to demonstrate the effectiveness of supportive housing for families in the child welfare system. The Design Options for Understanding Child Maltreatment project is now under way and intends to identify new methods to obtain accurate and ongoing information on the incidence of child abuse and neglect, as well as key research priorities for the field. 96 Finally, funds from this account have been used to help establish the National Advisory Committee on Sex Trafficking of Children and Youth in the United States. 97 
+
+ HHS awards CAPTA Discretionary Activities funds to eligible public and private entities (on a competitive basis) to carry out the required and/or authorized CAPTA activities. In some years, Congress has also indicated more specific uses for these funds as part of the appropriations process. For example, in each of FY2014-FY2017, report language or explanatory statements accompanying final appropriations bills have called for a part of this CAPTA funding to be used for "implementation of research-based court team models that include the court system, child welfare agency, and community organizations in order to better meet the needs of infants and toddlers in foster care." 98 HHS has responded by funding the Quality Improvement Center (QIC) for Research-Based Infant-Toddler Court Teams. 
+
+ The CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ) extended annual discretionary funding for CAPTA's discretionary activities through FY2015. Congress continued to provide funding for this account in FY2016 and FY2017. For final CAPTA discretionary activities funding for FY2013-FY2017, see Table 11 .
+
+ Community-Based Grants to Prevent Child Abuse and Neglect
+
+ Title II of CAPTA supports the efforts of community-based organizations to prevent child abuse and neglect. These prevention grants—referred to by HHS as Community-Based Child Abuse Prevention grants (CBCAP)—are distributed by formula to a lead entity in each state and territory. The lead entity is required to distribute the funds to community-based organizations in the state that work to prevent child abuse and neglect, including through support of parent education, mutual support, and self-help activities; provision of community and social service referrals, outreach services, voluntary home visiting, and respite care; and support for public information campaigns to prevent child abuse or neglect. The lead entity is often the state child welfare agency but may also be another statewide (public or private) entity (e.g., a state Children's Trust Fund). 
+
+ Out of funds provided for these grants, the law provides that 1% of funds must be set aside for tribal and migrant programs. In addition, it permits HHS to allocate whatever sums are necessary to support the work of state lead entities by creating, operating, and maintaining a peer review process, information clearinghouse, and computerized communication system between state lead entities and to fund a yearly symposium and biannual conference related to implementing the grants. As part of carrying out this requirement, HHS supports the National Resource Center for Community Based Child Abuse Prevention (also known as FRIENDS) to provide training and technical assistance for state lead entities. 
+
+ The CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ) extended annual discretionary funding for CBCAP through FY2015 (i.e., until September 30, 2015). Congress chose to continue to provide funding for these grants in FY2016 and in FY2017. Final funding for CBCAP grants, for each of FY2013-FY2017, is shown in Table 11 . 
+
+ To receive its allotment under the program, a state lead agency must assure that it will provide no less than 20% in nonfederal matching funds. 99 Further, each state's allocation of CBCAP funds is based in part on the amount of nonfederal money leveraged by the state for child abuse prevention activities. Specifically, 70% of the grant funding is distributed to each state and territory based on its relative share of children (individuals under age 18) in the nation (except that by statute no state may receive less than $175,000). 100 The remaining 30% of the grant funding is distributed to each state (including Puerto Rico) based on the relative share of all nonfederal (private, state, local) funds that was directed through the state's lead entity to fund community-based child abuse prevention services and activities.
+
+ 
+ 
+ Table 11. Final Funding for Child Abuse Prevention and Treatment Act (CAPTA)
+
+ (nominal dollars in millions; parts may not sum to total due to rounding)
+
+ 
+
+ 
+ 
+ 
+ CAPTA
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL appropriation 
+
+ 
+ 
+ $87 .9 
+
+ 
+ 
+ $93 .8 
+
+ 
+ 
+ $93 .8 
+
+ 
+ 
+ $98.1 
+
+ 
+ 
+ $98.1 
+
+ 
+ 
+ 
+ 
+ CAPTA State Grants —Formula grants to states and territories
+
+ 
+ 
+ $24.7
+
+ 
+ 
+ $25.3
+
+ 
+ 
+ $25.3
+
+ 
+ 
+ $25.3
+
+ 
+ 
+ $25.3
+
+ 
+ 
+ 
+ 
+ CAPTA Discretionary Activities —Competitive grants, contracts, or agreements to eligible entities
+
+ 
+ 
+ $24.1
+
+ 
+ 
+ $28.7 a 
+
+ 
+ 
+ $28.7 a 
+
+ 
+ 
+ $33.0 a 
+
+ 
+ 
+ $33.0 a 
+
+ 
+ 
+ 
+ 
+ Community-Based Gr ants to Prevent Child Abuse and Neglect —Formula grants to states and territories, includes support for technical assistance and 1% set aside for tribal/migrant programs 
+
+ 
+ 
+ $38.9
+
+ 
+ 
+ $39.8
+
+ 
+ 
+ $39.8
+
+ 
+ 
+ $39.8
+
+ 
+ 
+ $39.8
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Notes: The FY2013 funding shown reflects the final operating level after application of sequestration (which was applicable to each of these CAPTA accounts). Section 107 of CAPTA includes program authority for Children's Justice Act grants (42 U.S.C. §5106c). However, no funding is authorized to be provided for those grants under CAPTA. Instead, those funds, as discussed in a succeeding section of this report, are provided annually out of the Crime Victims Fund (42 U.S.C. §10603a). 
+
+ a. The explanatory statement accompanying the final funding for FY2014 ( P.L. 113-76 ) provided that $3 million of CAPTA discretionary activities funding was to be used to support "implementation of research-based court team models that include the court system, child welfare agency, and community organizations in order to better meet the needs of infants and toddlers in foster care." HHS/ACF responded by funding the Quality Improvement Center (QIC) for Research-Based Infant-Toddler Court Teams. Comparable statements (or report language) accompanying FY2015 ( P.L. 113-235 ), FY2016 ( P.L. 114-113 ) and FY2017 ( P.L. 115-31 ) final funding measures have indicated that support for this purpose should be continued. For example, the explanatory statement accompanying the bill that became P.L. 115-31 notes that the CAPTA discretionary activities account includes funds to "preserve, disseminate, and amplify the work of the Quality Improvement Center for Research-based Infant-Toddler Court Teams by providing training and technical assistance in support of such court teams' efforts across the country."
+
+ 
+
+ 
+
+ Children's Justice Act Grants
+
+ Children's Justice Act grants (Section 107 of CAPTA) administered by HHS are provided to help states and territories improve the assessment, investigation, and/or prosecution of child abuse and neglect cases—particularly cases involving suspected sexual abuse and exploitation of children, child fatalities suspected to be caused by abuse or neglect, and those involving children who are disabled and children with serious health disorders. Among other things, the improvements must aim to limit additional trauma to a child and/or child's family. 101 
+
+ To be eligible to receive these funds, a state or territory must meet the requirements necessary to receive CAPTA state grants, and it must establish and maintain a multidisciplinary taskforce to review how the state handles civil and criminal child abuse and neglect cases, including cases involving more than one jurisdiction (e.g., state and tribe, or more than one state). The taskforce must make recommendations for ways to improve handling of these cases through reform of state law, regulations, and procedures; training; and/or testing of innovative or experimental programs. States are further required to receive recommendations from the taskforce every three years and must implement the recommendations (or an alternative plan). 
+
+ While the program authority for Children's Justice Act grants is contained in Section 107 of CAPTA, that law does not authorize funding for them. Instead, the grants are funded out of the Crime Victims Fund (CVF). The CVF consists primarily of criminal fines and fees that are paid to the federal government. It is administered by the Office for Victims of Crime within the Department of Justice (DOJ). 102 Section 1404A of the Victims of Crime Act (42 U.S.C. §10601, et seq.) requires DOJ to annually set aside up to $20 million for Children's Justice Act purposes, of which 85% is directed to HHS (for distribution to 50 states, the District of Columbia, and Puerto Rico), 103 and the remaining 3% is retained by DOJ for competitive grants to tribal entities. FY2013-FY2017 funding for this program is shown in Table 12 .
+
+ 
+ 
+ Table 12. Final Funding for Children's Justice Act Grants
+
+ (nominal dollars in millions; funding for these grants is not appropriated but is provided annually out of the Crime Victims Fund, or CVF)
+
+ 
+
+ 
+ 
+ 
+ Children's Justice Act Grants
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL (set-aside out of CVF) 
+
+ 
+ 
+ $20.0 
+
+ 
+ 
+ $20.0 
+
+ 
+ 
+ $20.0 
+
+ 
+ 
+ $20.0 
+
+ 
+ 
+ $20.0 
+
+ 
+ 
+ 
+ 
+ Formula grants to states and territories (administered by HHS)
+
+ 
+ 
+ $17.0
+
+ 
+ 
+ $17.0
+
+ 
+ 
+ $17.0
+
+ 
+ 
+ $17.0
+
+ 
+ 
+ $17.0
+
+ 
+ 
+ 
+ 
+ Competitive grants to tribes (administered by DOJ)
+
+ 
+ 
+ $3.0
+
+ 
+ 
+ $3.0
+
+ 
+ 
+ $3.0
+
+ 
+ 
+ $3.0
+
+ 
+ 
+ $3.0
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS).
+
+ Note: For FY2013, certain funding provided from the Crime Victims Fund was subject to sequestration. However, this did not affect the level of funding set aside for Children's Justice Act grants. This table assumes the same treatment of this funding for each of FY2014-FY2017. 
+
+ 
+
+ 
+
+ Victims of Child Abuse Act
+
+ Title II of the Crime Control Act of 1990 ( P.L. 101-647 ) created the Victims of Child Abuse Act (VCAA). That act authorizes several child welfare programs that are administered by the Office of Juvenile Justice and Delinquency Programs (OJJDP), an agency within the Office of Justice Programs (OJP) at DOJ. 104 Apart from these three programs, the VCAA includes provisions requiring specified professionals to report suspected child abuse or neglect that they learn about while carrying out their profession on federal land or in federally operated facilities , and provides criminal penalties for those failing to make such reports. Additionally, it requires federal agencies and agencies operated or contracted to operate by the federal government to ensure criminal background checks are conducted for any individual hired by the agency or facility to provide a wide range of care or services to children. The legislation establishing the VCAA was handled by the Senate and House judiciary committees.
+
+ Improving Investigation and Prosecution of Child Abuse Cases
+
+ Subtitle A (Sections 211-214B) of the Victims of Child Abuse Act 105 supports the expansion and improvement of Children's Advocacy Centers (CACs). These centers are intended to coordinate a multidisciplinary response to child abuse (e.g., law enforcement, child protection/social service, medical, mental health) in a manner that ensures child abuse victims (and any non-offending family members) receive the support services they need and do not experience the investigation of child abuse as an added trauma. CACs are widespread. The VCAA authorizes funds to directly support establishment and operation of local and regional children's advocacy centers, as well as training and technical assistance related to improving the investigation and prosecution of child abuse and neglect.
+
+ Nationally there are close to 800 CACs located in all 50 states and the District of Columbia. Coverage varies significantly by state, and the National Children's Alliance reports that some 13.5 million children in the nation (about 1 in 5) live in areas without access to a CAC. 106 Close to 325,000 children were served at CACs in 2016, including nearly 222,000 who received an onsite forensic interview (68.1%). Many children received more than one service, which might include counseling or referrals to counseling, medical exam or treatment, and in some instances offsite forensic interviews. Children served were most often female (62.8%) and 12 years of age or younger (72.2%). More than half (53.1%) were white, about 1 in 5 (20.5%) were black, and about 14.5% were Hispanic or Latino. 107 
+
+ Sexual abuse was the most commonly reported abuse, involving about two-thirds (66.4%) of the children served at CACs in 2016. Children served may have experienced more than one type of abuse. Other abuses reported among children served were physical abuse (19.6%), neglect (7.4%), witnesses to violence (6.9%), child drug endangerment (3.3%), or "other" (5.7%). More than 6 in 10 of the alleged abusers (60.3%) were related to the children served (i.e., parent, step-parent, or other relative). Among all alleged offenders, about 8% were 12 years of age or younger and a little more than 10% were 13 through 17 years of age. 108 
+
+ For purposes of the CACs' work (and related technical training and assistance), "child abuse" is defined to mean "physical or sexual abuse or neglect of a child." As provided in the Justice for Victims of Trafficking Act of 2015 ( P.L. 114-22 ), this includes "human trafficking and the production of child pornography." That law also authorized grants to develop and implement specialized programs to identify and provide direct services to victims of child pornography. 109 Further, it established a Domestic Trafficking Victims Fund—to consist of financial penalties collected for certain human trafficking-related violations and other specified funds—and directed that a part of those dollars must be used (in each of FY2016-FY2019) to support those grants or enhance the programming related to responding to child pornography. 110 
+
+ Annually, DOJ awards the bulk of the CAC funding to the National Children's Alliance, which makes sub grants to support the work of local children's advocacy centers, establishes standards and provides accreditation to local and state chapter CACs, and offers other training and technical assistance. 111 Federal law also requires the establishment and support of four regional children's advocacy centers to increase the number of communities with CACs, help improve their practice, and support development of state chapter organizations for CACs, including by serving as resource and training centers for those local CACs and state chapters. 112 Currently the four regional centers are located in Huntsville, AL; Philadelphia, PA; St. Paul, MN; and Colorado Springs, CO. 113 In addition, the law seeks to improve the prosecution of child abuse cases by authorizing additional funds specifically for training and technical assistance to attorneys and others involved in criminal prosecution of child abuse. Funding to support this purpose has frequently been awarded to the National Center for the Prosecution of Child Abuse. 114 
+
+ Annual discretionary funding authority to support regional and local CACs ($15 million) and training and technical assistance to improve criminal prosecution of child abuse ($5 million) was extended for each of five years (FY2014-FY2018) by P.L. 113-163 . 115 
+
+ For FY2017, Congress provided $21 million, $1 million more than was provided for this account in FY2016. Senate Appropriations Committee report language (made applicable to the funding by the explanatory statement accompanying the final FY2017 appropriations act) stipulates that not less than 90% of the funds are provided "for the purposes of developing and maintaining child advocacy centers, including training and accreditation" and that $5 million must be used to support Regional Children's Advocacy Centers. The additional $1 million, it notes, is provided to "support a pilot project to identify, develop, and operationalize best practices," whereby the CAC model and expertise can be used to help address child abuse on military installations. 116 See Table 13 for FY2013-FY2017 final funding. 
+
+ Court-Appointed Special Advocates
+
+ Subtitle B (Sections 215-219) of the Victims of Child Abuse Act 117 provides funding to support access to advocates for victims of child abuse or neglect. Court Appointed Special Advocates (CASAs)—sometimes called guardians ad litem —are volunteers who are appointed by judges and who work to ensure that a child's best interest is presented to the judge in court proceedings related to child abuse and neglect.
+
+ The first CASA pilot program began in Seattle in the late 1970s, and the National Court Appointed Special Advocate Association (National CASA Association) was founded in 1982 to help replicate and support CASA programs across the nation. In 1984, when the association incorporated, there were 107 state and local CASA programs in 26 states. 118 As of 2015, close to 950 state, local, and tribal CASA programs located in 49 states and the District of Columbia were a part of the National CASA Association. 119 
+
+ As early as 1974, when Congress enacted CAPTA, it sought to ensure that every child who was a part of court proceedings because of child abuse and neglect had a guardian ad litem to represent their best interest. 120 However, 16 years later, when it authorized funds specifically for CASA (as part of the 1990 Victims of Child Abuse Act), Congress found that only a small fraction of children in child abuse and neglect proceedings received CASA representation. It stated then that the purpose of the funding dedicated to CASA was to ensure that each of these children would have a CASA made available to them. 121 In 2015, more than 250,000 children—most of who were in foster care—were served by nearly 77,000 CASA volunteers. However, the National CASA estimated that as many as 452,000 children in need of a CASA volunteer during 2015 did not have one. 122 
+
+ Each year funds appropriated for CASA authorization have been awarded to the National CASA Association, which awards sub grants (on a competitive basis) to be used for new local program development or expansion of existing programs and state CASA organizations. The National CASA Association also uses this federal funding to provide training and technical assistance to local CASA programs, child welfare professionals, attorneys, judges, social workers, and volunteer advocates.
+
+ As part of the reauthorization of the Violence Against Women Act ( P.L. 113-4 ), Congress extended annual discretionary funding authority for the CASA program at $12 million for each of FY2014-FY2018. Final federal funding appropriated for the CASA program in each of FY2013-FY2017 (shown in Table 13 ) has been less than this authorized level.
+
+ Child Abuse Training for Judicial Personnel and Practitioners 
+
+ Sections 221-224 of the Victims of Child Abuse Act of 1990 123 required OJJDP to make grants to improve the judicial system's handling of child abuse and neglect cases. The statute authorizes grants to be made to national organizations to develop model technical assistance and training programs. 124 Beginning with FY1992, funding appropriated under this authority has been awarded to the National Council of Juvenile and Family Court Judges (NCJFCJ). Drawing on the experience and reform initiatives it has funded in 36 "model courts" across the nation, NCJFCJ has developed resource guidelines and provides technical assistance and training aimed at improving how courts handle child abuse and neglect cases. 125 
+
+ Since the early 1990s, Congress has provided annual funding dedicated to this training program (with or without current funding authority), and in early 2013, as part of reauthorization of the Violence Against Women Act ( P.L. 113-4 ), it extended annual discretionary funding authority for the program at $2.3 million for each of FY2014-FY2018. Final federal funding appropriated for Child Abuse Training for Judicial Personnel and Practitioners in each of FY2013-FY2017 is shown in Table 13 . 
+
+ 
+ 
+ Table 13. Final Funding for Programs Under the Victims of Child Abuse Act (VCAA)
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ VCAA Funding
+
+ 
+ 
+ FY2013 
+
+ 
+ 
+ FY2014 
+
+ 
+ 
+ FY2015 
+
+ 
+ 
+ FY2016 
+
+ 
+ 
+ FY2017 
+
+ 
+ 
+ 
+ 
+ Children's Advocacy Centers (and related training and technical assistance)
+
+ 
+ 
+ $17.7
+
+ 
+ 
+ $19.0
+
+ 
+ 
+ $19.0
+
+ 
+ 
+ $20.0
+
+ 
+ 
+ $21.0
+
+ 
+ 
+ 
+ 
+ Court Appointed Special Advocates 
+
+ 
+ 
+ $5.6
+
+ 
+ 
+ $6.0
+
+ 
+ 
+ $6.0
+
+ 
+ 
+ $9.0
+
+ 
+ 
+ $9.0
+
+ 
+ 
+ 
+ 
+ Child Abuse Training for Judicial Personnel and Practitioners 
+
+ 
+ 
+ $1.4
+
+ 
+ 
+ $1.5
+
+ 
+ 
+ $1.5
+
+ 
+ 
+ $2.0
+
+ 
+ 
+ $2.0
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note: The FY2013 funding shown reflects the final operating level after application of sequestration. 
+
+ 
+
+ 
+
+ Other Programs
+
+ Additional child welfare programs are included in separate acts as described below. Legislation authorizing these programs and activities is handled by the House Education and the Workforce Committee and the Senate HELP Committee.
+
+ Adoption Opportunities
+
+ First enacted in 1978, 126 the Adoption Opportunities program 127 requires HHS to have an administrative structure that allows for centralized planning across all departmental programs and activities affecting foster care and adoption. It requires HHS to support adoption recruitment activities, including through a "national adoption information exchange" and to support a national resource center on special needs adoptions. Additionally, it authorizes federal funds to support projects or other activities that encourage and facilitate adoption of older children, children who are members of minority groups, and others with "special needs;" aim to eliminate barriers to cross-jurisdictional (including interstate) placement of children in need of adoption; and provide postadoption supports. Postadoption supports are described by the law as including individual, group, and family counseling; respite care; day treatment; case management; assistance to support groups for adoptive parents, adopted children, and siblings of adopted children; assistance to adoptive parent organizations; and training of public and private child welfare personnel, mental health professionals, and others to provide postadoption services.
+
+ Adoption Opportunities funds are used by HHS to achieve program purposes, either directly or by competitive award of contracts, grants, or other agreements. Depending on the activity authorized, eligible entities include states, local government entities, public or private child welfare or adoption agencies, other public or private agencies or organizations, adoptive family groups, and adoption exchanges. 128 Some of the Adoption Opportunities "major" program activities have included 129 
+ developing and implementing a national adoption information exchange system (which includes an online web portal known as AdoptUSKids featuring a national photo listing of children available for adoption as well as information about prospective foster or adoptive parents ); 
+
+ developing and implementing an adoption training and technical assistance program (current projects include the Quality Improvement Center on Adoption/Guardianship Support and Preservation and support for adoption-related information on the Child Welfare Information Gateway);
+
+ conducting ongoing, extensive recruitment efforts on a national level to encourage the adoption of older children, minority children, and special needs children (current work includes support for the National Resource Center for Diligent Recruitment of Foster and Adoptive Parents and a series of Public Service Announcements intended to encourage adoption of children, especially older children and children who are part of sibling groups);
+
+ increasing states' effective use of public and private agencies for the recruitment of adoptive and foster families and assistance in placement of children;
+
+ promoting programs to increase the number of older children adopted from foster care; 
+
+ providing for programs aimed at increasing the number of minority children (in foster care and with the goal of adoption) who are placed in adoptive families, with a special emphasis on recruitment of minority families; and
+
+ providing for postadoption services for families who have adopted children with special needs, and promoting programs that effectively meet the mental health needs of children in foster care, including addressing the effects of trauma. 
+ Reducing interstate barriers to placement of children has been a long-running concern of the program, and HHS has recently used Adoption Opportunities funding to extend support for the National Electronic Interstate Compact Enterprise (NEICE) project for three years. Six states initially participated in a NEICE pilot, which enabled electronic exchange of data needed to process interstate placement of children. Evaluation of the pilot found reduced placement time and other improved efficiencies. By funding a continuation of this project through May 2018 HHS hopes to extend use of the system to all states. As of June 2017, 15 of the 50 states and the District of Columbia were participating. 130 
+
+ Annual discretionary funding for the Adoption Opportunities program was authorized at $40 million for FY2010 and "such sums as necessary" for each of FY2011 through FY2015. Congress chose to continue appropriations for the program in FY2016, and again in FY2017. (See Table 14 for final Adoption Opportunities funding in FY2013-FY2017.) 
+
+ Report language intended to guide agency use of FY2017 Adoption Opportunities funding encourages HHS/ACF to "fund activities to improve hospital-based adoption support services for pregnant and expectant mothers, including training for hospital staff and doctors. Such activities would help ensure that mothers who wish to make an adoption have access to trained staff and comprehensive supports throughout the adoption process." 131 
+
+ 
+ 
+ Table 14. Final Funding for Adoption Opportunities
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Adoption Opportunities
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Competitively awarded funds for national initiatives, state or local projects, and other activities to reduce barriers to special needs adoptions
+
+ 
+ 
+ $36.7
+
+ 
+ 
+ $40.6 a 
+
+ 
+ 
+ $39.1
+
+ 
+ 
+ $39.1
+
+ 
+ 
+ $39.1
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note: The FY2013 funding shown reflects the final operating level after application of sequestration. 
+
+ a. Out of this funding, the explanatory statement accompanying the bill that became the Consolidated Appropriations Act, 2014 ( P.L. 113-76 ), states that $4 million must be for "discretionary grants to test intensive and exhaustive child-focused adoptive parent recruitment strategies for children in foster care." The Senate Appropriations Committee report, incorporated in that statement, also noted continued concern "about the availability of post-adoption services for children and their adoptive families" and "strongly" encouraged increased use of the program funding for purposes related to such services. HHS responded by awarding eight 17-month grants to public and private agencies related to child-focused recruitment of adoptive parents, announcing a National Adoption Competency Mental Health Training Initiative to improve the ability of child welfare staff and mental health practitioners to meet needs of children with a permanency goal of adoption/guardianship or those who have already been placed for adoption or guardianship; and awarding support for a National Quality Improvement Center for Adoption/Guardianship Support to develop evidence-based service models to improve behavioral health of children and youth in adoptive/guardianship families, among other things.
+
+ 
+
+ 
+
+ Abandoned Infants Assistance
+
+ The Abandoned Infants Assistance Act of 1988 ( P.L. 100-505 ) responded to congressional concerns about the number of infants who remained in hospital care beyond their medical need to do so and who, often because of parental drug use, were born with exposure to drugs, human immunodeficiency virus (HIV), or both. 132 The act authorized funding for local demonstration projects to prevent and respond to the abandonment of infants and young children. Congress last provided funding for this program ($11 million) in FY2015.
+
+ For purposes of this program, the terms abandoned and abandonment of infants or young children refer to infants or young children who are "medically cleared for discharge from acute-care hospital settings, but remain hospitalized because of a lack of appropriate out-of-hospital placement alternatives." To address the needs of these infants and young children it authorizes local demonstration projects to
+ provide services to biological family members for any condition that increases the probability of the abandonment of infants and young children; 
+
+ identify and address the needs of abandoned infants and children; 
+
+ assist abandoned infants and young children so they can live with biological family members, or, if appropriate, in a foster family home—or, if neither of those is possible, by carrying out residential (group) care programs for them;
+
+ recruit, train, and retain foster parents for abandoned infants and young children; 
+
+ provide respite care services to families and foster families of abandoned infants and young children who are infected with HIV, had perinatal exposure to HIV and/or a "dangerous drug," or who have a life-threatening illness or other special medical need;
+
+ provide model programs offering health, educational, and social services for abandoned infants and young children at a single site; and
+
+ recruit and train health and social services personnel to work with families, foster care providers, and residential care programs serving abandoned infants and young children. 
+ HHS awarded funds to public and private nonprofits seeking to carry out these local projects. Grantees were required to agree to give priority for services to abandoned infants or young children who are infected with HIV, had perinatal exposure to HIV or a controlled substance, or who have a life-threatening illness or other special medical need. From FY1991 through FY2015, HHS funded the National Abandoned Infants Assistance Resource Center, which disseminated findings from evaluations of the project (as required by the act) and offered training and technical assistance to local project grantees. The center is now closed. 133 
+
+ Survey data from the mid-2000s suggest that the number of infants who remain in hospital care beyond their date of medical discharge, as well as the number of infants in hospitals who are not yet medically cleared to leave the hospital but who are considered unlikely to do so with their biological parent(s), has declined. In 2006, the combined national estimate of such infants was a little less than 12,900. This was substantially fewer than the estimates of more than 30,600 such infants in 1998, and 21,600 in 1991. 134 However, the 2006 survey found that while these infants used to be concentrated in urban area hospitals, they were now more widely dispersed across the nation, appearing in hospitals serving suburban and rural counties as well as those in urban areas. The 2006 survey concluded that positive trends it identified, including a decline in the number of infants "boarded" in the hospital and reduced lengths of stay for those who did stay beyond their medical need to do so, might be attributable to hospitals and child welfare agencies becoming more responsive to needs of these infants, including through better interagency coordination. 
+
+ Several legislative efforts were cited as possible contributors. These included an increased focus on timely permanency planning (a major focus of the Adoption and Safe Families Act [ASFA] of 1997), required communication between health care providers and child protection agencies for children born with substance exposure (added to CAPTA as part of its 2003 reauthorization, P.L. 108-36 ), 135 and more than 20 years of federal support, provided under the Abandoned Infants Assistance Act ( P.L. 100-505 , as amended), for local projects to serve abandoned infants and children, and their families in communities across the nation.
+
+ Beginning with its extension in 1996, funding for Abandoned Infants Assistance has been a part of legislation that reauthorizes CAPTA. Most recently the CAPTA Reauthorization Act of 2010 ( P.L. 111-320 ) extended discretionary funding authority for the program at $45 million for FY2010 and "such sums as may be necessary" for each of FY2011 through FY2015. Congress has not provided funding for this program since FY2015. (See Table 15 .)
+
+ 
+ 
+ Table 15. Final Funding for Abandoned Infants Assistance
+
+ (nominal dollars in millions)
+
+ 
+
+ 
+ 
+ 
+ Abandoned Infants Assistance
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ Competitive grants, contracts, or agreements to eligible entities for services, technical assistance, and training
+
+ 
+ 
+ $10.8
+
+ 
+ 
+ $11.1
+
+ 
+ 
+ $11.1
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by the Congressional Research Service (CRS). 
+
+ Note: The FY2013 funding shown reflects the final operating level after application of sequestration.
+
+ 
+
+ 
+
+ While noting the program's success, the Obama Administration in its FY2016 budget sought authority to use these program funds on behalf of a broader range of at-risk infants and toddlers. 136 Congress, instead, chose not to provide funding for this program for FY2016. The Senate Appropriations Committee in its report on Labor-HHS-Education appropriations for FY2016 137 stated the following:
+
+ The Committee recommendation does not include funding for this program. The budget request proposes significantly changing the focus of this program as part of a reauthorization proposal. The Abandoned Infants Assistance program was created in 1988 as a response to an acute child welfare crisis associated with the crack cocaine and HIV/AIDS epidemics of the 1980s. Specifically, the program funded demonstration projects to prevent the abandonment of infants and young children impacted by substance abuse and HIV. As the budget request discusses, over the last several decades, in part because of these demonstration projects, States have implemented more effective community responses to infants and families in these circumstances, the goal of these demonstration projects. 
+
+ Appendix A.
+
+ Recent Funding by Program
+
+ Table A-1 shows the funding amounts appropriated (or obligated) based on the part of the Social Security Act in which they are authorized (Title IV-B or Title IV-E) or their location outside of the Social Security Act (other programs). This mirrors the broad categories included in Table 1 . 
+
+ For more detail on funding for programs for which the amount shown below is a total of multiple activities or program components, see Table 3 and Table 4 (Promoting Safe and Stable Families program); Table 7 (Title IV-E foster care, adoption assistance, and kinship guardianship assistance); Table 9 (Chafee Foster Care Independence Program, including Education and Training Vouchers); Table 11 (Child Abuse Prevention and Treatment Act, or CAPTA, including state grants, discretionary activities, and community-based grants); and Table 13 (Victims of Child Abuse Act, or VCAA, including Children's Advocacy Centers, Court-Appointed Special Advocates, and Child Abuse Training for Judicial Personnel).
+
+ 
+ 
+ Table A-1. Child Welfare Program Funding by Fiscal Year
+
+ (nominal dollars in millions; parts may not sum to total due to rounding)
+
+ 
+
+ 
+ 
+ 
+ Program
+
+ 
+ 
+ FY2013
+
+ 
+ 
+ FY2014
+
+ 
+ 
+ FY2015
+
+ 
+ 
+ FY2016
+
+ 
+ 
+ FY2017
+
+ 
+ 
+ 
+ 
+ TOTAL 
+
+ 
+ 
+ $7,578 
+
+ 
+ 
+ $8,390 
+
+ 
+ 
+ $8,279 
+
+ 
+ 
+ $8 ,603 
+
+ 
+ 
+ $ 8,898 
+
+ 
+ 
+ 
+ 
+ Title IV-B of the Social Security Act 
+
+ 
+ 
+ $688 
+
+ 
+ 
+ $689 
+
+ 
+ 
+ $664 
+
+ 
+ 
+ $668 
+
+ 
+ 
+ $668 
+
+ 
+ 
+ 
+ 
+ Stephanie Tubbs Jones Child Welfare Services (CWS)
+
+ 
+ 
+ $262
+
+ 
+ 
+ $269
+
+ 
+ 
+ $269
+
+ 
+ 
+ $269
+
+ 
+ 
+ $269
+
+ 
+ 
+ 
+ 
+ Promoting Safe and Stable Families (PSSF)
+ (Total: mandatory and discretionary funds, all activities) 
+
+ 
+ 
+ $387
+
+ 
+ 
+ $380
+
+ 
+ 
+ $380
+
+ 
+ 
+ $381
+
+ 
+ 
+ $381
+
+ 
+ 
+ 
+ 
+ Child Welfare Research, Training, and Demonstration
+
+ 
+ 
+ $24
+
+ 
+ 
+ $25
+
+ 
+ 
+ $16
+
+ 
+ 
+ $18
+
+ 
+ 
+ $18
+
+ 
+ 
+ 
+ 
+ Family Connection Grants
+
+ 
+ 
+ $14
+
+ 
+ 
+ $15
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ Title IV-E of the Social Security Act 
+
+ 
+ 
+ $6,710 
+
+ 
+ 
+ $7,510 
+
+ 
+ 
+ $7,424 
+
+ 
+ 
+ $7, 746 
+
+ 
+ 
+ $ 8, 041 
+
+ 
+ 
+ 
+ 
+ Title IV-E Foster Care, Adoption and Guardianship
+ (Total for all three components with open-ended funding) 
+
+ 
+ 
+ $6,487
+
+ 
+ 
+ $7,286
+
+ 
+ 
+ $7,200
+
+ 
+ 
+ $7,522
+
+ 
+ 
+ $7,817
+
+ 
+ 
+ 
+ 
+ Tribal IV-E Plan Development and Technical Assistance
+
+ 
+ 
+ $3
+
+ 
+ 
+ $3
+
+ 
+ 
+ $3
+
+ 
+ 
+ $3
+
+ 
+ 
+ $3
+
+ 
+ 
+ 
+ 
+ Chafee Foster Care Independence Program (CFCIP)
+ (Total: Basic program and Education and Training Vouchers) 
+
+ 
+ 
+ $182
+
+ 
+ 
+ $183
+
+ 
+ 
+ $183
+
+ 
+ 
+ $183
+
+ 
+ 
+ $183
+
+ 
+ 
+ 
+ 
+ Adoption and Legal Guardianship Incentive Payments
+
+ 
+ 
+ $37
+
+ 
+ 
+ $38
+
+ 
+ 
+ $38
+
+ 
+ 
+ $38
+
+ 
+ 
+ $38
+
+ 
+ 
+ 
+ 
+ Other Programs 
+
+ 
+ 
+ $180 
+
+ 
+ 
+ $192 
+
+ 
+ 
+ $190 
+
+ 
+ 
+ $188 
+
+ 
+ 
+ $189 
+
+ 
+ 
+ 
+ 
+ Child Abuse Prevention and Treatment Act (CAPTA)
+ (Total: State Grants, Discretionary Activities and Community-Based Grants to Prevent Child Abuse and Neglect) 
+
+ 
+ 
+ $88
+
+ 
+ 
+ $94
+
+ 
+ 
+ $94
+
+ 
+ 
+ $98
+
+ 
+ 
+ $98
+
+ 
+ 
+ 
+ 
+ Children's Justice Act Grants 
+
+ 
+ 
+ $20
+
+ 
+ 
+ $20
+
+ 
+ 
+ $20
+
+ 
+ 
+ $20
+
+ 
+ 
+ $20
+
+ 
+ 
+ 
+ 
+ Adoption Opportunities
+
+ 
+ 
+ $37
+
+ 
+ 
+ $41
+
+ 
+ 
+ $39
+
+ 
+ 
+ $39
+
+ 
+ 
+ $39
+
+ 
+ 
+ 
+ 
+ Abandoned Infants Assistance
+
+ 
+ 
+ $11
+
+ 
+ 
+ $11
+
+ 
+ 
+ $11
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ Victims of Child Abuse Act (VCAA)
+ (Total for Children's Advocacy Centers, Court Appointed Special Advocates, and Child Abuse Training for Judicial Personnel) 
+
+ 
+ 
+ $25
+
+ 
+ 
+ $27
+
+ 
+ 
+ $27
+
+ 
+ 
+ $31
+
+ 
+ 
+ $32
+
+ 
+ 
+ 
+ 
+ Source: Table prepared by Congressional Research Service. For funding of program components or parts and for additional notes about these amounts, see individual program funding tables in the body of this report. Title IV-E funding shown may vary from previous versions of the table based on revised budget authority or obligations.
+
+ 
+
+ 
+
+ Appendix B.
+
+ Child Welfare Programs by Type of Funding Authority and Sequestration Status
+
+ The Budget Control Act of 2011 (BCA, P.L. 112-25 ) included a combination of measures affecting discretionary and mandatory spending that are designed to reduce the federal deficit by a certain amount. With regard to discretionary spending, the BCA established certain spending caps for FY2012-FY2021. The caps provide limits on the total dollar amount of federal spending Congress may appropriate on a discretionary basis. If those caps are exceeded, automatic spending cuts called sequestration must be applied. The BCA has been amended several times. Most recently the Bipartisan Budget Act of 2015 ( P.L. 114-74 ) increased the level of discretionary spending permitted for both FY2016 and FY2017.
+
+ The BCA of 2011 also included certain targets for reductions in mandatory spending and provided that if Congress did not achieve deficit reductions through other means, sequestration must be used to achieve those targets. 138 The Bipartisan Budget Act of 2015 ( P.L. 114-74 ) extended the required sequestration of mandatory spending through FY2025. 139 
+
+ Sequestration Determinations by Fiscal Year
+
+ For FY2013 only, sequestration was applied to both discretionary and mandatory accounts. For that year, the sequestration percentage determined necessary to bring nonexempt, nondefense discretionary-funded program spending under the statutory spending cap was 5.0%. Separately, to achieve the deficit reduction targets set in the law, sequestration of nonexempt, nondefense mandatory-funded program accounts was 5.1%. 
+
+ For each of FY2014 through FY2017, OMB determined that discretionary appropriations did not exceed the discretionary spending caps for nondefense program. Therefore, sequestration was not required for these discretionary programs. However, sequestration was required for mandatory-funded programs in each of those same years. The OMB issued sequestration orders, effective on the first day (October 1) of each of those fiscal years, which reduced spending for each nonexempt, nondefense mandatory program account by the following amounts: 7.2% for FY2014; 7.3% for FY2015; 6.8% for FY2016; and 6.9% for FY2017.
+
+ Sequestration Status by Child Welfare Program
+
+ Table B-1 lists each child welfare program described in this report by its type of funding authority (mandatory or discretionary) and notes whether program funds may be subject to sequestration. If the program is listed as one that may be subject to sequestration, it is referred to as "nonexempt" and is subject to automatic spending cuts in any fiscal year for which OMB determines spending has exceeded the statutory limit. If a program may not be subject to sequestration, it is referred to as "exempt," and automatic spending cuts do not apply to that program in any year. 
+
+ 
+ 
+ Table B-1. Funding Authority and Sequestration Status of Child Welfare Programs
+
+ 
+
+ 
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ Sequestration Determined Necessary for Nonexempt Programs (%)
+
+ 
+ 
+ 
+ 
+ Program
+
+ 
+ 
+ Type of Funding Authority
+
+ 
+ 
+ Program Subject to Sequestration If Determined Necessary?
+
+ 
+ 
+ FY
+2013
+
+ 
+ 
+ FY
+2014
+
+ 
+ 
+ FY
+2015
+
+ 
+ 
+ FY
+2016
+
+ 
+ 
+ FY
+2017
+
+ 
+ 
+ 
+ 
+ Title IV-E Foster Care, Adoption Assistance and Kinship Guardianship Assistance; Tribal Technical Assistance and IV-E Plan Development Grants 
+
+ 
+ 
+ Mandatory, open-ended
+
+ 
+ 
+ No
+(exempt) a 
+
+ 
+ 
+ Not applicable
+
+ 
+ 
+ 
+ 
+ Chafee Foster Care Independence Program (general program)
+
+ 
+ 
+ Mandatory, capped
+
+ 
+ 
+ No
+(exempt) a 
+
+ 
+ 
+ Not applicable
+
+ 
+ 
+ 
+ 
+ Chafee Educational and Training Vouchers 
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Promoting Safe and Stable Families Program (includes funding for state, territorial, and tribal child and family services, the Court Improvement Program, research and evaluation, Regional Partnership Grants and Monthly Caseworker Visit Grants) 
+
+ 
+ 
+ Mandatory, capped
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.1%)
+
+ 
+ 
+ Yes (7.2%)
+
+ 
+ 
+ Yes (7.3%)
+
+ 
+ 
+ Yes (6.8%)
+
+ 
+ 
+ Yes
+(6.9%)
+
+ 
+ 
+ 
+ 
+ Promoting Safe and Stable Families Program (includes funding for state, territorial, and tribal child and family services, the Court Improvement Program, and research and evaluation)
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Stephanie Tubbs Jones Child Welfare Services Program 
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Family Connection Grants 
+
+ 
+ 
+ Mandatory, capped
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.1%)
+
+ 
+ 
+ b 
+
+ 
+ 
+ b 
+
+ 
+ 
+ b 
+
+ 
+ 
+ b 
+
+ 
+ 
+ 
+ 
+ Child Welfare Research, Demonstrations, and Training 
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Child Abuse Prevention and Treatment Act (CAPTA) , including State Grants, Discretionary Activities, and Community-Based Grants to Prevent Child Abuse and Neglect
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Adoption and Legal Guardianship Incentive s, Adoption Opportunitie s, Abandoned Infants Assistance 
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No c 
+
+ 
+ 
+ No c 
+
+ 
+ 
+ 
+ 
+ Victims of Child Abuse Act Programs (Court Appointed Special Advocates, Children's Advocacy Centers, and Child Abuse Training for Judicial Personnel)
+
+ 
+ 
+ Discretionary
+
+ 
+ 
+ Yes
+(nonexempt)
+
+ 
+ 
+ Yes (5.0%)
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ No
+
+ 
+ 
+ 
+ 
+ Children's Justice Act Grants (funded as a set aside from the Crime Victims Fund) 
+
+ 
+ 
+ Mandatory, capped
+
+ 
+ 
+ No d 
+
+ 
+ 
+ No d 
+
+ 
+ 
+ No d 
+
+ 
+ 
+ No d 
+
+ 
+ 
+ No d 
+
+ 
+ 
+ No d 
+
+ 
+ 
+ 
+ 
+ Source: Congressional Research Service (CRS). A program's sequestration status is based on OMB Report to the Congress on the Joint Committee Reductions for Fiscal Year 2014 (May 2013). 
+
+a. Although the statute provides that mandatory Title IV-E funding is generally exempt (including all dollars authorized to be paid to states), a very small portion of this funding is considered as a cost of federal program administration and is subject to sequestration. 
+
+b. Family Connection Grants are not exempt and were subject to sequestration in FY2013. However, they were not a part of the authorized mandatory funding in FY2014 (used by OMB in early 2014 to determine whether the spending cap had been exceeded and by how much). Therefore, no sequestration applied to their FY2014 funding, which was provided, via P.L. 113-183 , on September 29, 2014. Congress did not provide funding for these grants in any of FY2015 through FY2017. 
+
+c. Congress did not provide funding for Abandoned Infants Assistance in either of FY2016 or FY2017. 
+
+d. Funding provided by the Crime Victims Fund is subject to sequestration. However, for FY2013, the statutory set-aside from the fund that is used to support Children's Justice Act Grants was not subject to sequestration. This table assumes this same policy applied for FY2014, FY2015, FY2016, and FY2017.
+
+ 
+
+ 
+
+ Appendix C.
+
+ Tribes with an Approved Title IV-E Plan
+
+ Beginning with FY2010, tribes with a Title IV-E plan approved by HHS may receive direct federal reimbursement for eligible costs related to providing foster care, adoption assistance, and, if they choose, kinship guardianship assistance. As of November 2017, the following 10 tribes/tribal entities had such an approved plan 140 :
+ Port Gamble S'Klallam Tribe (Kingston, WA)
+
+ Confederated Salish and Kootenai Tribes (Pablo, MT)
+
+ South Puget Intertribal Planning Agency (Shelton, WA)
+
+ Keweenaw Bay Indian Community (Baraga, MI)
+
+ Navajo Nation (Window Rock, AZ)
+
+ Chickasaw Nation (Ada, OK)
+
+ Eastern Band of Cherokee Indians (Cherokee, NC) 
+
+ Pascua Yaqui Tribe (Tucson, AZ)
+
+ Tolowa Dee-ni' Nation (near Smith River, CA) 
+
+ Salt River Pima-Maricopa Indian Community (Scottsdale, AZ)
+ Appendix D.
+
+ States with Approval to Extend Title IV-E Assistance up to Age 21
+
+ Beginning with FY2011, states and any other jurisdiction operating a Title IV-E program were permitted to amend their Title IV-E plans to allow federal assistance (foster care, adoption assistance, or kinship guardianship assistance) to be provided to otherwise eligible youth up to their 19 th , 20 th , or 21 st birthday. To be eligible for this extended Title IV-E assistance, a youth must be in foster care or must have left foster care for adoption or guardianship at age 16 or older.
+
+ As of April 2017, 29 jurisdictions, including 23 states, the District of Columbia, and 5 tribal entities had received approval to extend Title IV-E assistance to older youth. 141 Indiana extends Title IV-E assistance to a youth's 20 th birthday. All other jurisdictions listed below currently extend Title IV-E assistance to a youth's 21 st birthday. 
+
+ Otherwise eligible youth may continue to receive Title IV-E assistance after their 18 th birthday provided they meet additional eligibility requirements related to participation in education, work, or work preparation (or be documented as unable to participate due to a medical condition). Wisconsin only extends support beyond age 18 if the youth is in high school, and West Virginia, only does so if the youth is in high school or college. All other jurisdictions listed below extend support to older age if youth meets any one or more of the education, work, other participation, or disability criteria. 
+
+ States that choose to extend Title IV-E foster care assistance beyond a youth's 18 th birthday must also provide Title IV-E adoption assistance and Title IV-E kinship guardianship assistance (if the state offers that kind of Title IV-E assistance) to the same older age (and under same eligibility requirements) for any child who was aged 16 or older when he or she left foster care for adoption or guardianship.
+
+ 
+ 
+ Table D-1. Jurisdictions Extending Title IV-E Assistance Beyond Age 18
+
+ As of April 2017
+
+ 
+
+ 
+ 
+ 
+ Alabama
+
+ 
+ 
+ Arkansas
+
+ 
+ 
+ California
+
+ 
+ 
+ 
+ 
+ Connecticut
+
+ 
+ 
+ District of Columbia
+
+ 
+ 
+ Hawaii
+
+ 
+ 
+ 
+ 
+ Illinois
+
+ 
+ 
+ Indiana
+
+ 
+ 
+ Maine
+
+ 
+ 
+ 
+ 
+ Maryland
+
+ 
+ 
+ Massachusetts
+
+ 
+ 
+ Michigan
+
+ 
+ 
+ 
+ 
+ Minnesota
+
+ 
+ 
+ Nebraska
+
+ 
+ 
+ New York
+
+ 
+ 
+ 
+ 
+ North Dakota
+
+ 
+ 
+ Oregon
+
+ 
+ 
+ Pennsylvania
+
+ 
+ 
+ 
+ 
+ Tennessee
+
+ 
+ 
+ Texas
+
+ 
+ 
+ Virginia
+
+ 
+ 
+ 
+ 
+ Washington
+
+ 
+ 
+ West Virginia
+
+ 
+ 
+ Wisconsin
+
+ 
+ 
+ 
+ 
+ Eastern Band of Cherokee (NC)
+
+ 
+ 
+ Navajo Nation (AZ, NM, UT)
+
+ 
+ 
+ Keweenaw Bay Indian Community (MI)
+
+ 
+ 
+ 
+ 
+ Pascua Yaqui (AZ)
+
+ 
+ 
+ Tolowa Dee-ni' Nation (formerly known as Smith River Rancheria) (CA)
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+
+ Appendix E.
+
+ States with Child Welfare Demonstration (Waiver) Projects 
+
+ Twenty-eight jurisdictions, including 26 states, the District of Columbia, and the Port Gamble S'Klallam Tribe, are currently approved to operate 28 child welfare demonstration projects. These demonstrations are often referred to Title IV-E waiver projects. 
+
+ Five states (California, Florida, Illinois, Indiana, and Ohio) have been operating their waiver projects for roughly a decade or longer. The remaining jurisdictions received approval to operate a waiver project between September 2012 and September 2014, and as of April 2017 have been implementing them for anywhere from a few months to several years. 142 
+
+ Three states that were approved to implement a Title IV-E waiver project between FY2012 and FY2014 (Idaho, Montana, and Texas) subsequently opted not to implement the project, or ended implementation early. Although the exact reasons varied, competing priorities for the child welfare agency and cost concerns appear to have played a role in each state.
+
+ Table E-1 below lists each state with a Title IV-E waiver project operating as of April 2017 and lists the focus of the project as well as its start and (scheduled) end date. For additional information on current projects, see the following resources: 
+ Detailed Summary Table (updated March 2017) showing by jurisdiction each waiver project's core interventions , target population(s) (e.g., may be limited by age, service need, part of state), key outcomes to be followed, and cost neutrality methodology ; https://www.acf.hhs.gov/sites/default/files/cb/waiver_summary_table_active.pdf . 
+
+ Short report (August 2016) summarizing and categorizing current waiver projects by proposed intervention and evaluation design; includes some discussion of findings from previous waiver projects along with preliminary findings from the current round of projects; http://www.acf.hhs.gov/sites/default/files/cb/cw_waiver_summary2016.pdf . 
+ Additional resources, including findings from past projects, are also available from the Children's Bureau waiver site: http://www.acf.hhs.gov/cb/programs/child-welfare-waivers .
+
+ 
+
+ 
+ 
+ Table E-1. Jurisdictions Implementing Child Welfare Waiver Projects.
+
+ 
+
+ 
+ 
+ 
+ State/Other Jurisdiction
+
+ 
+ 
+ Demonstration Focus
+
+ 
+ 
+ Start ( or most recent extension) -Scheduled End 
+
+ 
+ 
+ 
+ 
+ Arizona
+
+ 
+
+ 
+ 
+ "Right-size" use of congregate care. 
+
+ 
+ 
+ July 1, 2016-Sept. 30,2019
+
+ 
+ 
+ 
+ 
+ Arkansas 
+
+ 
+ 
+ Assessment, family engagement, and differential response.
+
+ 
+ 
+ July 31, 2013-July 30, 2018
+
+ 
+ 
+ 
+ 
+ California
+
+ 
+ 
+ Flexible funding, develop and implement core practice model/safety-organized practice, wrap-around services for youth at risk of placement due to delinquency. 
+
+ 
+ 
+ July 1, 2007 (extended Oct. 1, 2014)-Sept. 30, 2019 
+
+ 
+ 
+ 
+ 
+ Colorado
+
+ 
+ 
+ Family engagement, assessment, kinship supports, and trauma-informed services.
+
+ 
+ 
+ July 31, 2013-July 30, 2018
+
+ 
+ 
+ 
+ 
+ District of Columbia
+
+ 
+ 
+ Intensive in-home prevention, family preservation, and post-reunification services; expanded service array.
+
+ 
+ 
+ April 25, 2014-April 24, 2019
+
+ 
+ 
+ 
+ 
+ Florida
+
+ 
+ 
+ Improve array of community-based services, including early intervention and in-home services to prevent foster care placement or re-entry.
+
+ 
+ 
+ Oct. 1, 2006 (extended Oct. 1, 2013)-Sept. 30, 2018
+
+ 
+ 
+ 
+ 
+ Hawaii
+
+ 
+ 
+ Crisis response system, intensive home-based services, services to expedite permanency.
+
+ 
+ 
+ Jan. 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Illinois a 
+
+ 
+ 
+ Services for caregivers with substance use disorders, parenting education services to improve healthy development and parent-child attachment for very young children, and "immersion sites" to provide stable home-like care for children in care and reduce length of stay.
+
+ 
+ 
+ July 1, 2013 - June 30, 2018
+
+ 
+ 
+ 
+ 
+ Indiana
+
+ 
+ 
+ Flexible funding: increase array, intensity, and accessibility of services to prevent foster care placement.
+
+ 
+ 
+ Jan. 1, 1998 (extended July 1, 2012)-March 31, 2018
+
+ 
+ 
+ 
+ 
+ Kentucky
+
+ 
+ 
+ Services to preserve families with identified substance abuse and/or family violence risk factors.
+
+ 
+ 
+ Oct. 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Maine
+
+ 
+ 
+ Parental education and services for caregivers with substance use disorders.
+
+ 
+ 
+ April 1, 2016-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Maryland
+
+ 
+ 
+ Trauma-informed assessment, workforce development related to understanding trauma, and other evidence-based practices identified as needed by localities.
+
+ 
+ 
+ July 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Massachusetts
+
+ 
+ 
+ Improved residential care and community-based services for youth transitioning out of, or at-risk of, such care.
+
+ 
+ 
+ Jan. 1, 2014-Dec. 31, 2018
+
+ 
+ 
+ 
+ 
+ Michigan
+
+ 
+ 
+ Intensive early intervention case management and services.
+
+ 
+ 
+ Aug. 1, 2013-July 31, 2018
+
+ 
+ 
+ 
+ 
+ Nebraska
+
+ 
+ 
+ Alternative Response, including links to expanded parenting education; Results Based Accountability included in state's contract and performance management system.
+
+ 
+ 
+ July 1, 2014-June 30, 2019
+
+ 
+ 
+ 
+ 
+ Nevada
+
+ 
+ 
+ Safety management services model; enhanced service array.
+
+ 
+ 
+ July 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ New York
+
+ 
+
+ 
+ 
+ Trauma-informed assessment and evidenced-based services for children in foster care, reduced caseloads.
+
+ 
+ 
+ Jan. 1, 2014-Dec. 31, 2018
+
+ 
+ 
+ 
+ 
+ Ohio
+
+ 
+ 
+ Flexible funding: family team meetings and kinship supports, other services to prevent placement or promote permanency for children as chosen by county. 
+
+ 
+ 
+ Oct. 1, 1997 (extended Oct. 1, 2016)-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Oklahoma
+
+ 
+ 
+ Short-term, intensive home-based services.
+
+ 
+ 
+ July 22, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Oregon b 
+
+ 
+ 
+ Leveraging Intensive Family Engagement to reduce likelihood of long-term foster care stays (includes enhanced family finding, improved case planning, and parent mentor program).
+
+ 
+ 
+ July 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Pennsylvania
+
+ 
+ 
+ Family engagement (including family group decisionmaking and family team conferencing), assessments, and other services as determined by county.
+
+ 
+ 
+ July 1, 2013-June 30, 2018
+
+ 
+ 
+ 
+ 
+ Port Gamble S'Klallam Tribe
+
+ 
+ 
+ Parenting education and support and enhanced family engagement.
+
+ 
+ 
+ Jan. 21, 2016-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Rhode Island
+
+ 
+ 
+ Structured decisionmaking, director's approval and prior authorization process, expedited permanency meetings. 
+
+ 
+ 
+ Oct. 31, 2016-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Tennessee
+
+ 
+ 
+ Assessment, supporting kinship and foster parents; and parenting education and supports.
+
+ 
+ 
+ Oct. 1, 2014-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Utah
+
+ 
+ 
+ Assessment, caseworker tools and training, and evidence-based in-home services.
+
+ 
+ 
+ Oct. 1, 2013-Sept. 30, 2018
+
+ 
+ 
+ 
+ 
+ Washington
+
+ 
+ 
+ Differential response.
+
+ 
+ 
+ Jan. 1, 2014-Dec. 31, 2018
+
+ 
+ 
+ 
+ 
+ West Virginia
+
+ 
+ 
+ Wraparound services. 
+
+ 
+ 
+ Oct. 1, 2015-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Wisconsin
+
+ 
+ 
+ Post-reunification case management services.
+
+ 
+ 
+ Oct. 1, 2013-Sept. 30, 2019
+
+ 
+ 
+ 
+ 
+ Source: Congressional Research Service (CRS), based primarily on "Summary Table of Active Title IV-E Waiver Demonstrations" as of August 2016 and incorporating updates received by CRS from HHS/ACF, Children's Bureau, April 2017. 
+
+ a. As of January 1, 2017, Illinois is operating a single waiver project that incorporates both of its two prior projects (previously approved on a separate basis and referred to as AODA and IB3) and also includes a new project component, the "immersion site initiative." 
+
+ b. Oregon had a prior waiver project; instead of seeking its extension, the state sought and received approval for this new project. 
+
+ 
+
+ 
+
+ Appendix F.
+
+ Jurisdictions with Approval to Provide Title IV-E Kinship Guardianship Assistance 
+
+ As of June 2017, jurisdictions (including 35 of the 50 states, the District of Columbia, and 8 tribal entities) have received HHS approval to provide kinship guardianship assistance under their Title IV-E plans.
+
+ 
+ 
+ Table F-1. Jurisdictions Approved to Provide Title IV-E Kinship Guardianship Assistance 
+
+ 
+
+ 
+ 
+ 
+ Alabama
+
+ 
+ 
+ Alaska
+
+ 
+ 
+ Arkansas
+
+ 
+ 
+ 
+ 
+ California
+
+ 
+ 
+ Colorado
+
+ 
+ 
+ Connecticut
+
+ 
+ 
+ 
+ 
+ District of Columbia
+
+ 
+ 
+ Hawaii
+
+ 
+ 
+ Idaho
+
+ 
+ 
+ 
+ 
+ Illinois
+
+ 
+ 
+ Indiana
+
+ 
+ 
+ Louisiana
+
+ 
+ 
+ 
+ 
+ Maine
+
+ 
+ 
+ Maryland
+
+ 
+ 
+ Massachusetts
+
+ 
+ 
+ 
+ 
+ Michigan
+
+ 
+ 
+ Minnesota
+
+ 
+ 
+ Missouri
+
+ 
+ 
+ 
+ 
+ Montana
+
+ 
+ 
+ Nebraska
+
+ 
+ 
+ Nevada
+
+ 
+ 
+ 
+ 
+ New Jersey
+
+ 
+ 
+ New Mexico
+
+ 
+ 
+ New York
+
+ 
+ 
+ 
+ 
+ North Carolina
+
+ 
+ 
+ Oklahoma
+
+ 
+ 
+ Oregon
+
+ 
+ 
+ 
+ 
+ Pennsylvania
+
+ 
+ 
+ Rhode Island
+
+ 
+ 
+ South Dakota
+
+ 
+ 
+ 
+ 
+ Tennessee
+
+ 
+ 
+ Texas
+
+ 
+ 
+ Vermont
+
+ 
+ 
+ 
+ 
+ Washington
+
+ 
+ 
+ West Virginia
+
+ 
+ 
+ Wisconsin
+
+ 
+ 
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Confederated Salish and Kootenai Tribe (MT)
+
+ 
+ 
+ Eastern Band of the Cherokee Indians (NC)
+
+ 
+ 
+ Keweenaw Bay Indian Community (MI)
+
+ 
+ 
+ 
+ 
+ Navajo Nation (AZ, NM, UT)
+
+ 
+ 
+ Pascua Yaqui Tribe (AZ)
+
+ 
+ 
+ Port Gamble S'Klallam Tribe (WA)
+
+ 
+ 
+ 
+ 
+ South Puget Intertribal Planning Agency (WA)
+
+ 
+ 
+ Tolowa Dee-Ni Nation (formerly Smith River Rancheria) (CA)
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ Source: HHS/ACF, Children's Bureau, as of June 27, 2017
+
+ 
+
+ 
+
+ 
+
+ Appendix G.
+
+ Adoption and Legal Guardianship Incentive Payments
+
+ In September 2017, HHS announced incentive payments earned by states for their performance in FY2016. As shown below, states earned more than $55.2 million in incentive payments, a record for the program. However, at the time of its announcement HHS had only about $5.3 million on hand to make these payments. This amount was distributed to states on a prorated basis (so that each state received roughly 10% of the amount it earned for its FY2016 performance). The $5.3 million awarded to states in September 2017 was the total of program funds that remained after HHS completed awarding states $41.1 million for their success at increasing the rate of adoptions and legal guardianships during FY2015. That amount was paid out in September 2016 (using $8.6 million in FY2016 program funding) and in June 2017 (using $32.5 million in FY2017 funding). 
+
+ Table G-1 shows the amount of incentive funding earned in FY2016 by state for each incentive category. The next to the last column shows the total earned for all categories in FY2016 ($55.2 million), and the final column shows the amount of that total that was paid as of September 30, 2016 ($5.3 million). Assuming full-year FY2018 appropriations for Adoption and Legal Guardianship Incentive Payments are made later this year, HHS may provide more of the outstanding incentive payments earned by states for FY2016 performance. However, unless FY2018 funding for the payments exceeds the recent annual appropriations level of $37.9 million, HHS will not be able to pay the full $49.9 million in outstanding payments earned. 
+
+ 
+ 
+ Table G-1. Incentive Payments Earned for Increases in Adoption and Legal Guardianships Completed in FY2016
+
+ 
+
+ 
+ 
+ 
+ State
+
+ 
+ 
+ Adoptions (any age)
+
+ 
+ 
+ Legal Guardianships (any age)
+
+ 
+ 
+ Preadolescent Adoptions or Legal Guardianship
+(ages 9 -13)
+
+ 
+ 
+ Older Adoptions or Legal Guardianships (age 14 or older)
+
+ 
+ 
+ TOTAL Incentive Payment Earned for FY2016
+
+ 
+ 
+ Amount of TOTAL Paid as of September 30, 2017
+
+ 
+ 
+ 
+ 
+ Alabama
+
+ 
+ 
+ $0
+
+ 
+ 
+ $88,000
+
+ 
+ 
+ $90,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $178,000
+
+ 
+ 
+ $17,208
+
+ 
+ 
+ 
+ 
+ Alaska
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $80,000
+
+ 
+ 
+ $80,000
+
+ 
+ 
+ $7,734
+
+ 
+ 
+ 
+ 
+ Arizona
+
+ 
+ 
+ $740,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $340,000
+
+ 
+ 
+ $1,080,000
+
+ 
+ 
+ $104,411
+
+ 
+ 
+ 
+ 
+ Arkansas
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ California
+
+ 
+ 
+ $3,875,000
+
+ 
+ 
+ $2,540,000
+
+ 
+ 
+ $3,105,000
+
+ 
+ 
+ $2,100,000
+
+ 
+ 
+ $11,620,000
+
+ 
+ 
+ $1,123,384
+
+ 
+ 
+ 
+ 
+ Colorado
+
+ 
+ 
+ $420,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $105,000
+
+ 
+ 
+ $50,000
+
+ 
+ 
+ $575,000
+
+ 
+ 
+ $55,589
+
+ 
+ 
+ 
+ 
+ Connecticut
+
+ 
+ 
+ $435,000
+
+ 
+ 
+ $76,000
+
+ 
+ 
+ $15,000
+
+ 
+ 
+ $240,000
+
+ 
+ 
+ $766,000
+
+ 
+ 
+ $74,054
+
+ 
+ 
+ 
+ 
+ Delaware
+
+ 
+ 
+ $70,000
+
+ 
+ 
+ $108,000
+
+ 
+ 
+ $75,000
+
+ 
+ 
+ $70,000
+
+ 
+ 
+ $323,000
+
+ 
+ 
+ $31,227
+
+ 
+ 
+ 
+ 
+ District of Columbia
+
+ 
+ 
+ $55,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $30,000
+
+ 
+ 
+ $30,000
+
+ 
+ 
+ $115,000
+
+ 
+ 
+ $11,118
+
+ 
+ 
+ 
+ 
+ Florida
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ Georgia
+
+ 
+ 
+ $120,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $120,000
+
+ 
+ 
+ $11,601
+
+ 
+ 
+ 
+ 
+ Hawaii
+
+ 
+ 
+ $0
+
+ 
+ 
+ $40,000
+
+ 
+ 
+ $15,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $55,000
+
+ 
+ 
+ $5,317
+
+ 
+ 
+ 
+ 
+ Idaho
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $7,500
+
+ 
+ 
+ $0
+
+ 
+ 
+ $7,500
+
+ 
+ 
+ $725
+
+ 
+ 
+ 
+ 
+ Illinois
+
+ 
+ 
+ $0
+
+ 
+ 
+ $572,000
+
+ 
+ 
+ $150,000
+
+ 
+ 
+ $360,000
+
+ 
+ 
+ $1,082,000
+
+ 
+ 
+ $104,604
+
+ 
+ 
+ 
+ 
+ Indiana
+
+ 
+ 
+ $1,000,000
+
+ 
+ 
+ $284,000
+
+ 
+ 
+ $352,500
+
+ 
+ 
+ $600,000
+
+ 
+ 
+ $2,236,500
+
+ 
+ 
+ $216,217
+
+ 
+ 
+ 
+ 
+ Iowa
+
+ 
+ 
+ $480,000
+
+ 
+ 
+ $116,000
+
+ 
+ 
+ $427,500
+
+ 
+ 
+ $180,000
+
+ 
+ 
+ $1,203,500
+
+ 
+ 
+ $116,350
+
+ 
+ 
+ 
+ 
+ Kansas
+
+ 
+ 
+ $240,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $105,000
+
+ 
+ 
+ $20,000
+
+ 
+ 
+ $365,000
+
+ 
+ 
+ $35,287
+
+ 
+ 
+ 
+ 
+ Kentucky
+
+ 
+ 
+ $840,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $75,000
+
+ 
+ 
+ $130,000
+
+ 
+ 
+ $1,045,000
+
+ 
+ 
+ $101,027
+
+ 
+ 
+ 
+ 
+ Louisiana
+
+ 
+ 
+ $160,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $60,000
+
+ 
+ 
+ $200,000
+
+ 
+ 
+ $420,000
+
+ 
+ 
+ $40,604
+
+ 
+ 
+ 
+ 
+ Maine
+
+ 
+ 
+ $480,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $97,500
+
+ 
+ 
+ $140,000
+
+ 
+ 
+ $717,500
+
+ 
+ 
+ $69,366
+
+ 
+ 
+ 
+ 
+ Maryland
+
+ 
+ 
+ $350,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $120,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $470,000
+
+ 
+ 
+ $45,438
+
+ 
+ 
+ 
+ 
+ Massachusetts
+
+ 
+ 
+ $125,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $125,000
+
+ 
+ 
+ $12,085
+
+ 
+ 
+ 
+ 
+ Michigan
+
+ 
+ 
+ $2,510,000
+
+ 
+ 
+ $288,000
+
+ 
+ 
+ $337,500
+
+ 
+ 
+ $1,010,000
+
+ 
+ 
+ $4,145,500
+
+ 
+ 
+ $400,773
+
+ 
+ 
+ 
+ 
+ Minnesota
+
+ 
+ 
+ $215,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $135,000
+
+ 
+ 
+ $230,000
+
+ 
+ 
+ $580,000
+
+ 
+ 
+ $56,072
+
+ 
+ 
+ 
+ 
+ Mississippi
+
+ 
+ 
+ $290,000
+
+ 
+ 
+ $524,000
+
+ 
+ 
+ $285,000
+
+ 
+ 
+ $190,000
+
+ 
+ 
+ $1,289,000
+
+ 
+ 
+ $124,616
+
+ 
+ 
+ 
+ 
+ Missouri
+
+ 
+ 
+ $985,000
+
+ 
+ 
+ $860,000
+
+ 
+ 
+ $547,500
+
+ 
+ 
+ $920,000
+
+ 
+ 
+ $3,312,500
+
+ 
+ 
+ $320,242
+
+ 
+ 
+ 
+ 
+ Montana
+
+ 
+ 
+ $0
+
+ 
+ 
+ $228,000
+
+ 
+ 
+ $22,500
+
+ 
+ 
+ $110,000
+
+ 
+ 
+ $360,500
+
+ 
+ 
+ $34,852
+
+ 
+ 
+ 
+ 
+ Nebraska
+
+ 
+ 
+ $140,000
+
+ 
+ 
+ $172,000
+
+ 
+ 
+ $82,500
+
+ 
+ 
+ $400,000
+
+ 
+ 
+ $794,500
+
+ 
+ 
+ $76,810
+
+ 
+ 
+ 
+ 
+ Nevada
+
+ 
+ 
+ $350,000
+
+ 
+ 
+ $120,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $240,000
+
+ 
+ 
+ $710,000
+
+ 
+ 
+ $68,640
+
+ 
+ 
+ 
+ 
+ New Hampshire
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ New Jersey
+
+ 
+ 
+ $945,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $397,500
+
+ 
+ 
+ $130,000
+
+ 
+ 
+ $1,472,500
+
+ 
+ 
+ $142,356
+
+ 
+ 
+ 
+ 
+ New Mexico
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $90,000
+
+ 
+ 
+ $90,000
+
+ 
+ 
+ $8,701
+
+ 
+ 
+ 
+ 
+ New York
+
+ 
+ 
+ $860,000
+
+ 
+ 
+ $512,000
+
+ 
+ 
+ $270,000
+
+ 
+ 
+ $390,000
+
+ 
+ 
+ $2,032,000
+
+ 
+ 
+ $196,447
+
+ 
+ 
+ 
+ 
+ North Carolina
+
+ 
+ 
+ $530,000
+
+ 
+ 
+ $436,000
+
+ 
+ 
+ $307,500
+
+ 
+ 
+ $130,000
+
+ 
+ 
+ $1,403,500
+
+ 
+ 
+ $135,686
+
+ 
+ 
+ 
+ 
+ North Dakota
+
+ 
+ 
+ $50,000
+
+ 
+ 
+ $112,000
+
+ 
+ 
+ $127,500
+
+ 
+ 
+ $170,000
+
+ 
+ 
+ $459,500
+
+ 
+ 
+ $44,423
+
+ 
+ 
+ 
+ 
+ Ohio
+
+ 
+ 
+ $195,000
+
+ 
+ 
+ $8,000
+
+ 
+ 
+ $157,500
+
+ 
+ 
+ $0
+
+ 
+ 
+ $360,500
+
+ 
+ 
+ $34,852
+
+ 
+ 
+ 
+ 
+ Oklahoma
+
+ 
+ 
+ $3,505,000
+
+ 
+ 
+ $236,000
+
+ 
+ 
+ $1,290,000
+
+ 
+ 
+ $1,130,000
+
+ 
+ 
+ $6,161,000
+
+ 
+ 
+ $595,625
+
+ 
+ 
+ 
+ 
+ Oregon
+
+ 
+ 
+ $60,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $127,500
+
+ 
+ 
+ $280,000
+
+ 
+ 
+ $467,500
+
+ 
+ 
+ $45,196
+
+ 
+ 
+ 
+ 
+ Pennsylvania
+
+ 
+ 
+ $0
+
+ 
+ 
+ $48,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $590,000
+
+ 
+ 
+ $638,000
+
+ 
+ 
+ $61,680
+
+ 
+ 
+ 
+ 
+ Rhode Island
+
+ 
+ 
+ $400,000
+
+ 
+ 
+ $104,000
+
+ 
+ 
+ $165,000
+
+ 
+ 
+ $220,000
+
+ 
+ 
+ $889,000
+
+ 
+ 
+ $85,946
+
+ 
+ 
+ 
+ 
+ South Carolina
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $217,500
+
+ 
+ 
+ $0
+
+ 
+ 
+ $217,500
+
+ 
+ 
+ $21,027
+
+ 
+ 
+ 
+ 
+ South Dakota
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $40,000
+
+ 
+ 
+ $40,000
+
+ 
+ 
+ $3,867
+
+ 
+ 
+ 
+ 
+ Tennessee
+
+ 
+ 
+ $500,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $225,000
+
+ 
+ 
+ $110,000
+
+ 
+ 
+ $835,000
+
+ 
+ 
+ $80,725
+
+ 
+ 
+ 
+ 
+ Texas
+
+ 
+ 
+ $1,660,000
+
+ 
+ 
+ $1,236,000
+
+ 
+ 
+ $952,500
+
+ 
+ 
+ $850,000
+
+ 
+ 
+ $4,698,500
+
+ 
+ 
+ $454,236
+
+ 
+ 
+ 
+ 
+ Utah
+
+ 
+ 
+ $165,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $75,000
+
+ 
+ 
+ $80,000
+
+ 
+ 
+ $320,000
+
+ 
+ 
+ $30,937
+
+ 
+ 
+ 
+ 
+ Vermont
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $110,000
+
+ 
+ 
+ $110,000
+
+ 
+ 
+ $10,634
+
+ 
+ 
+ 
+ 
+ Virginia
+
+ 
+ 
+ $235,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $15,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $250,000
+
+ 
+ 
+ $24,169
+
+ 
+ 
+ 
+ 
+ Washington
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ West Virginia
+
+ 
+ 
+ $0
+
+ 
+ 
+ $28,000
+
+ 
+ 
+ $37,500
+
+ 
+ 
+ $170,000
+
+ 
+ 
+ $235,500
+
+ 
+ 
+ $22,767
+
+ 
+ 
+ 
+ 
+ Wisconsin
+
+ 
+ 
+ $65,000
+
+ 
+ 
+ $172,000
+
+ 
+ 
+ $270,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $507,000
+
+ 
+ 
+ $49,015
+
+ 
+ 
+ 
+ 
+ Wyoming
+
+ 
+ 
+ $45,000
+
+ 
+ 
+ $80,000
+
+ 
+ 
+ $0
+
+ 
+ 
+ $140,000
+
+ 
+ 
+ $265,000
+
+ 
+ 
+ $25,619
+
+ 
+ 
+ 
+ 
+ Puerto Rico
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ $0
+
+ 
+ 
+ 
+ 
+ T OTAL 
+
+ 
+ 
+ $23,095,000 
+
+ 
+ 
+ $8,988,000 
+
+ 
+ 
+ $10,875,000 
+
+ 
+ 
+ $12,270,000 
+
+ 
+ 
+ $55,228,000 
+
+ 
+ 
+ $5,339,262 
+
+ 
+ 
+ 
+ 
+ Source: Payments based on information received by CRS from HHS, ACF, ACYF, Children's Bureau in November 2017. To see total annual incentive payments made under this program (beginning with adoptions completed in FY1998), see https://www.acf.hhs.gov/ sites/ default/ files/ cb/ adoption_incentive_history.pdf . 
+
+ Note : The incentive structure, including the baseline against which improvement is measured, categories for which incentive payments are made, and the amounts payable, have varied considerably across the life of the program. See Appendix D in CRS Report R43025, Child Welfare: The Adoption Incentive Program and Its Reauthorization . 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+ Author Contact Information
+ 
+ [author name scrubbed], Specialist in Social Policy
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ See CRS Report R42794, Child Welfare: State Plan Requirements under the Title IV-E Foster Care, Adoption Assistance, and Kinship Guardianship Assistance Program .
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ See CRS In Focus IF10590, Child Welfare: Purposes, Federal Programs, and Funding .
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ Kristina Rosinsky and Dana Connelly Child Welfare Spending in SFY 2014: A Survey of Federal, State, and Local Expenditures , Child Trends, Annie E. Casey Foundation, and Casey Family Programs, October 2016. Medicaid spending counted in this survey excludes spending on basic health care for children (which is typically a state Medicaid agency expenditure). Instead it includes only the spending on Medicaid services or activities for which the state child welfare agency was responsible for providing the nonfederal share of the program costs (e.g., targeted case management, rehabilitative services, Medicaid-funded therapeutic foster care, and associated administrative costs). 
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ For more information on TANF, see CRS Report R40946, The Temporary Assistance for Needy Families Block Grant: An Overview ; for more information on SSBG, see CRS Report 94-953, Social Services Block Grant: Background and Funding ; and for more information on Medicaid, see CRS Report R43357, Medicaid: An Overview .
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ See Section 101(a) and (b) of Division D in P.L. 115-56 , as extended by Division A of P.L. 115-90 .
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ See Section 111 of Division D in P.L. 115-56 , as extended by Division A of P.L. 115-90 .
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ Sections 109 and 110 of Division D of P.L. 115-56 , as continued by Division A of P.L. 115-90 . 
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ For trends in federal Title IV-E spending provided under the open-ended authorization see Figure 11-7 in the U.S. House Ways and Means, 2016 Green Book at http://greenbook.waysandmeans.house.gov/2016-green-book/chapter-11-child-welfare . 
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ For trends in federal Title IV-B funding, which represents the largest share of capped or discretionary funding provided for child welfare purposes, see Figure 11-9 in the U.S. House Ways and Means, 2016 Green Book ; http://greenbook.waysandmeans.house.gov/2016-green-book/chapter-11-child-welfare .
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ See Appendix, "Budget Enforcement Actions," in CRS Report R44478, Status of FY2017 Labor-HHS-Education Appropriations . 
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ Mandatory funding in "exempt" accounts remains subject to sequestration if it is used for federal administration purposes. For FY2017, $27 million in Title IV-E funding was used for federal administration purposes and was subject to sequestration (6.9% reduction); this reduced FY2017 spending under the Title IV-E program by about $2 million.
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ See OMB Report to the Congress on the Joint Committee Reductions for Fiscal Year 201 8 , May 23 2017, Appendix, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/sequestration_reports/2018_jc_sequestration_report_may2017_potus.pdf .
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ See OMB Report to the Congress on the Joint Committee Reductions for Fiscal Year 2017 , February 9, 2016, https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/legislative_reports/sequestration/jc_sequestration_report_2017_house.pdf .
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ The Office of Management and Budget (OMB) determined in a May 16, 2017 report that the FY2017 funding provided by Congress met the discretionary funding caps established for that year (via P.L. 112-25 , as amended by P.L. 114-74 ) or was within a technical scoring range (as permitted by P.L. 115-31 ). See OMB Seven Day After Report, May 16, 2017, https://www.whitehouse.gov/omb/public-releases/7dayafterreport . 
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ Funding amounts for each of FY2013-FY2017 shown in this report are generally based first on the relevant final appropriations laws for each fiscal year ( P.L. 112-74 , P.L. 113-6 , P.L. 113-76 , P.L. 113-235 , P.L. 114-113 , P.L. 115-31 ), including any official accompanying explanatory text or tables. However, the reported appropriation level reflects any sequestration applied to those accounts. Additionally, funding for Title IV-E foster care, adoption assistance, and kinship guardianship assistance are based on most recent estimate of obligations, or budget authority, available for a given year. Specifically for FY2013-FY2016, funding amounts shown in this report are based on federal obligations made for the year (as included in the most recent HHS ACF budget justifications with information for the year) and for FY2017 are based on estimates used by HHS ACF to prepare the July 2017 mid-session review of the budget .
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ Title IV-B also contains funding authority for the Mentoring Children of Prisoners program (Section 439). The program was established by the Promoting Safe and Stable Families Amendments of 2001 ( P.L. 107-133 ), received initial funding for FY2003 ($10 million), and received its most recent appropriation ($49 million) for FY2010. It is not discussed in this report.
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ For a more comprehensive discussion of this program, including funding by state, see CRS Report R41860, Child Welfare: Funding for Child and Family Services Authorized Under Title IV-B of the Social Security Act .
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ HHS, ACF, ACYF, Children's Bureau, Report to Congress on State Child Welfare Expenditures, 2017 (October 2017).
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ States are required to provide a greater share of program costs to receive this funding if they complete less than 95% of the expected monthly caseworker visits, and/or less than 50% of the visits occur where the child lives. For more information, see "Grants to Improve Monthly Caseworker Visits" in CRS Report R41860, Child Welfare: Funding for Child and Family Services Authorized Under Title IV-B of the Social Security Act .
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ The $325 million annual funding authorization level was added to the law as of FY1990; nominal dollar funding for the program has never exceeded the $295 million provided for CWS in FY1993.
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ For a more comprehensive discussion of this program, including service category definitions and funding by state, see CRS Report R41860, Child Welfare: Funding for Child and Family Services Authorized Under Title IV-B of the Social Security Act .
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ HHS, ACF, ACYF, Children's Bureau, Report to Congress on State Child Welfare Expenditures , 2017 (October 2017), p. 5. Percentages total more than 100 due to rounding. Collectively, states report spending more than 20% in each of the four service categories, but there is variation across states. According to HHS, states that spend less than 20% on a given category report doing so because other resources are available to support the services.
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ The reduction total was calculated by summing the mandatory PSSF funds sequestered in each of the five years, and, with the discretionary PSSF funds sequestered in FY2013. See Appendix B for more information.
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ This approach to PSSF funding for FY2017 was done in the absence of reauthorization of the PSSF mandatory funding at the $345 million level for FY2017. It allowed level funding for the PSSF program (and all related activities, including the CIP) between FY2016 and FY2017 while at the same time ensuring that the mandatory PSSF baseline, as it is understood by the Congressional Budget Office (CBO), would not be decreased. See also Table 3 , note "a". 
+
+ 
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ For a description of the Court Improvement Program, Regional Partnership Grants, and Monthly Caseworker Visit Grants, see the sections corresponding to those program names in CRS Report R41860, Child Welfare: Funding for Child and Family Services Authorized Under Title IV-B of the Social Security Act . 
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ Section 427(g) of the Social Security Act requires HHS to reserve 3% of program funds ($450,000) annually for evaluation and permits it to reserve an additional 2% ($300,000) annually for technical assistance. 
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ Some grantees receive more than one grant. For more information on the FY2009-FY2014 grantees, see project descriptions and reports at http://www.nrcpfc.org/grantees.html . Regarding the remaining funds awarded in FY2015 awards; see http://www.acf.hhs.gov/programs/cb/resource/discretionary-grant-awards-2015 . 
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ For cross-site evaluation findings and recommendations from the initial (2009-2011) grantees see the report at http://www.jbassoc.com/ReportsPublications/Fam Conn Summary and Recommendations 6-17-13 Stand-Alone Final.pdf. For evaluations of work regarding Family Group Decisionmaking, see http://www.acf.hhs.gov/sites/default/files/cb/family_connection_fgdm_2011_exesum.pdf and regarding residential family treatment programs see https://www.childwelfare.gov/pubPDFs/fam-conn-grantee-2012-rft-final-report.pdf . 
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ The funding provided in September 2014 was appropriated for FY2014 and was immediately used to provide a third year of project funding for 17 previous grantees (each of which received initial support with FY2012 dollars, awarded on September 30, 2012). Additionally, in FY2015 HHS used a small amount of FY2014 funding that remained unexpended to award three new Family Connection grants.
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ HHS, ACF, Justifications of Estimates for the Appropriations Committees, FY201 8 , May 2017, p. 117. 
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ For FY2010-FY2014, funding from this account was used to support six "Permanency Innovation" grantees, all of whom worked to demonstrate effective ways to reduce the number of children who stay in foster care for more than two years. Findings from the project continue to inform Section 426 activities, including the web-based training and technical assistance platform. See http://www.acf.hhs.gov/programs/cb/resource/pii-project-resources .
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ For FY2015, see explanatory statement at Congressional Record, Book II, December 11, 2014, p. H9838. For FY2016, see explanatory statement at Congressional Record, Book III, December 18, 2015, p. H10289. For FY2017, see explanatory statement at Congressional Record, Book III, May 3, 2017, p. H. 3954.
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ The initial NSCAW survey involved about 5,500 children (ages 0-15) in families investigated for child abuse and neglect between October 1999 and December 2000, as well as more than 700 children who had been in foster care for 12 months as of that timeframe. Subsequent data were collected on these same children (and their caregivers) at various intervals for five years following the first (baseline) data collection. The second NSCAW (referred to as NSCAW II) looked at a sample of close to 5,900 children (ages 0-17) in families investigated for child abuse and neglect between February 2008 and April 2009. Additional data were collected on these children and their families at two subsequent intervals for three years following the baseline data collected. Specific funding for NSCAW ended with FY2011; consequently, no further data were collected in the NSCAW II. 
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ Congress provided $6 million in each of FY1997-FY2011 for NSCAW but from FY2012 through FY2017, it has not provided specific NSCAW funding. To permit completion of some of the work begun with NSCAW II, HHS redirected funds from other research accounts in each of FY2012-FY2014, although the lack of funding meant fewer waves of data were collected or analyzed in the second iteration of the survey. Beginning with FY2015, Congress has directed HHS to use Section 426 research funds to support NSCAW, but it did not increase funding for that account.
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ This includes annual data reported to HHS by states via the Adoption and Foster Care Analysis Reporting System (AFCARS) and, separately, the National Child Abuse and Neglect Data System, NCANDS. 
+
+ 
+ 
+ 
+ 36 .
+ 
+ 
+ These resources are available from the HHS, ACF, Office of Planning Research and Evaluation (OPRE) website at http://www.acf.hhs.gov/programs/opre/research/project/national-survey-of-child-and-adolescent-well-being-nscaw .
+
+ 
+ 
+ 
+ 37 .
+ 
+ 
+ Several books derived from NSCAW data have been published, including Ron Haskins, Fred Wulczyn, and Mary Bruce Webb, eds., Child Protection: Using Research to Improve Policy and Practice , Brookings Institution Press, 2007, and Mary Bruce Webb, Kathryn Dowd, Brenda Jones Harden, John Landsverk, and Mark F. Testa, eds., Child Welfare & Child Well-Being: New Perspectives from the National Survey of Child and Adolescent Well-Being, Oxford University Press, 2010. 
+
+ 
+ 
+ 
+ 38 .
+ 
+ 
+ For information on Title IV-E plan requirements, see CRS Report R42792, Child Welfare: A Detailed Overview of Program Eligibility and Funding for Foster Care, Adoption Assistance and Kinship Guardianship Assistance under Title IV-E of the Social Security Act .
+
+ 
+ 
+ 
+ 39 .
+ 
+ 
+ The Northern Mariana Islands does not appear to be eligible to participate in Title IV-E. The other four territories (American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands) are eligible to participate in Title IV-E, provided they have an approved plan. Puerto Rico has had an approved Title IV-E plan since FY1998. The U.S. Virgin Islands received approval of its Title IV-E plan, effective with FY2017.
+
+ 
+ 
+ 
+ 40 .
+ 
+ 
+ Tribes first became eligible for direct Title IV-E program participation in FY2010. As was true before FY2010, however, numerous tribes receive indirect Title IV-E funds, which are passed through by states under tribal-state Title IV-E agreements. For additional information, see Jack Trope and Shannon Keller O'Loughlin, "A Survey and Analysis of Selected Tribal-State Title IV-E Agreements," March 2014, http://icwa.narf.org/wordpress/wp-content/uploads/2014/03/20140320_title_iv-e_report.pdf .
+
+ 
+ 
+ 
+ 41 .
+ 
+ 
+ Tribes without a IV-E plan may also receive direct federal funding for services to youth aging out of foster care (Chafee program), if they have a Title IV-E agreement with a state. 
+
+ 
+ 
+ 
+ 42 .
+ 
+ 
+ U.S. Committee on Ways and Means, 2016 Green Book, Chapter 11 , "Child Welfare," Additional Tables and Figures, Table 11-3; and HHS, ACF, ACYF, Children's Bureau, Trends in Foster Care and Adoption , October 2017.
+
+ 
+ 
+ 
+ 43 .
+ 
+ 
+ Unlike funding to states, which is "open-ended," all Title IV-E funding to territories is subject to a funding cap for "social services" specified in Section 1108(a) and (c) of the Social Security Act. The dollar amounts for these caps are specific to each of these territories and have not been changed since 1996. Federal funding which must be under this cap includes TANF state grants, certain federal funding provided to the territory for the aged, blind or disabled and any funding provided under Title IV-E 
+
+ 
+ 
+ 
+ 44 .
+ 
+ 
+ Based on state-submitted Title IV-E foster care expenditure claims for FY2016 as compiled by HHS, ACF, Office of Legislative Affairs and Budget (OLAB), May 2017.
+
+ 
+ 
+ 
+ 45 .
+ 
+ 
+ See data on national trends in Title IV-E federal foster care coverage and FY2015 estimated rates by states in Figure 11-5 and Table 11-5 of the " Child Welfare " chapter of the House Ways and Committee 2016 Green Book .
+
+ 
+ 
+ 
+ 46 .
+ 
+ 
+ CRS calculation based on a comparison of the FY2017 federal poverty guideline (for a family of three) to an annualized version of the applicable 1996 monthly "need standard" (or countable income) for a family of that same size in each state. Fifty percent of the FY2017 federal poverty guideline (for a family of three) equals $10,210 (in 48 contiguous states and DC); see https://aspe.hhs.gov/poverty-guidelines .
+
+ 
+ 
+ 
+ 47 .
+ 
+ 
+ The judge must also find that the state made reasonable efforts to prevent need to remove the child from the home (provided preservation/reunification efforts are considered necessary/appropriate by the court).
+
+ 
+ 
+ 
+ 48 .
+ 
+ 
+ See also, Child Welfare: A Detailed Overview of Program Eligibility and Funding for Foster Care, Adoption Assistance and Kinship Guardianship Assistance under Title IV-E of the Social Security Act.
+
+ 
+ 
+ 
+ 49 .
+ 
+ 
+ Title IV-E support for this purpose was authorized by the Preventing Sex Trafficking and Strengthening Families Act ( P.L. 113-183 ) and was available as of FY2015. For more information, See HHS, ACF, ACYF, Children's Bureau, PI-15-09 , December 2, 2015 and Child Welfare Policy Manual, Section 8.1 ., Q&A 7. 
+
+ 
+ 
+ 
+ 50 .
+ 
+ 
+ Tribes have a uniquely determined reimbursement rate for Title IV-E maintenance payments, which may not be less than the rate for any state the tribe is located in, and may not be more than 83%. States are reimbursed for maintenance payments at their Federal Medical Assistance Percentage (FMAP), which is used in the Medicaid program. See CRS Report R43847, Medicaid's Federal Medical Assistance Percentage (FMAP) . 
+
+ 
+ 
+ 
+ 51 .
+ 
+ 
+ Section1130(a)(2) and (d)(2) of the Social Security Act. 
+
+ 
+ 
+ 
+ 52 .
+ 
+ 
+ Summary of Child Welfare Waiver Demonstration by Jurisdictions, March 2017. Available on the Children's Bureau website at http://www.acf.hhs.gov/sites/default/files/cb/waiver_summary_table_active.pdf .
+
+ 
+ 
+ 
+ 53 .
+ 
+ 
+ Summary of the Title IV-E Child Welfare Waiver Demonstrations, prepared for Children's Bureau, ACYF, ACF, HHS by James Bell Associates, Inc., August 2016 at http://www.acf.hhs.gov/sites/default/files/cb/cw_waiver_summary2016.pdf . 
+
+ 
+ 
+ 
+ 54 .
+ 
+ 
+ Section 1130(b) prohibits HHS from waiving these federal child protections for children in foster care.
+
+ 
+ 
+ 
+ 55 .
+ 
+ 
+ Kristina Rosinsky and Dana Connelly Child Welfare Spending in SFY 2014: A Survey of Federal, State, and Local Expenditures , Child Trends, Annie E. Casey Foundation, and Casey Family Programs, October 2016, pp. 17-18.
+
+ 
+ 
+ 
+ 56 .
+ 
+ 
+ For additional information see discussion of "Title IV-E Adoption Assistance," in CRS Report R42792, Child Welfare: A Detailed Overview of Program Eligibility and Funding for Foster Care, Adoption Assistance and Kinship Guardianship Assistance under Title IV-E of the Social Security Act .
+
+ 
+ 
+ 
+ 57 .
+ 
+ 
+ FY2015 AFCARS data provided to CRS by HHS, ACF, ACYF, Children's Bureau, A very small number of these adoptions may be of children who were not previously in foster care.
+
+ 
+ 
+ 
+ 58 .
+ 
+ 
+ Federal support for this assistance is limited to 50% of total costs not exceeding $2,000 (i.e., maximum $1,000 federal reimbursement for nonrecurring costs of adoptive placement) (45 C.F.R. §1356.41(f)).
+
+ 
+ 
+ 
+ 59 .
+ 
+ 
+ For children on whose behalf an adoption assistance agreement is entered into at any time during FY2017, the additional Title IV-E income and related must be used in instances when the special needs adoptee will not reach his or her second birthday by the end of that fiscal year (i.e., as of September 30, 2017). C hildren with special needs who are siblings of those meeting the age or length of time in care (60 continuous months) criteria m ust also be determined eligible for Title IV-E adoption assistance without use of any income or related requirements, ( provided those siblings are placed in the same adoptive family with the sibling ) . As of the first day of FY2018 (October 1, 2017), the additional income and related requirements will no longer be a part of Title IV-E adoption assistance eligibility criteria for any child determined by a state to have "special needs." See Sections 473(a)(2(A)(ii) and 473(e) of the Social Security Act. 
+
+ 
+ 
+ 
+ 60 .
+ 
+ 
+ Based on state submitted Title IV-E adoption assistance expenditure claims for FY2016 as compiled by HHS, ACF, Office of Legislative Affairs and Budget (OLAB), May 2017. 
+
+ 
+ 
+ 
+ 61 .
+ 
+ 
+ For additional eligibility criteria, see "Kinship Guardianship Assistance," in CRS Report R42792, Child Welfare: A Detailed Overview of Program Eligibility and Funding for Foster Care, Adoption Assistance and Kinship Guardianship Assistance under Title IV-E of the Social Security Act .
+
+ 
+ 
+ 
+ 62 .
+ 
+ 
+ Based on state-submitted Title IV-E kinship guardianship assistance expenditure claims for FY2016, as compiled by HHS, ACF, OLAB, May 2017. The total number of children assisted on an average monthly basis includes more than 850 who were eligible for this assistance because they were receiving it under an approved child welfare demonstration (waiver) project, as of December 30, 2008. See Section 474(g) of the Social Security Act.
+
+ 
+ 
+ 
+ 63 .
+ 
+ 
+ Additionally, states may seek Title IV-E kinship guardianship assistance support for children who were in a subsidized guardianship under an approved Title IV-E waiver (demonstration project) as of December 30, 2008.
+
+ 
+ 
+ 
+ 64 .
+ 
+ 
+ Unlike states and tribes, any spending under Title IV-E by a territory is subject to a ceiling on federal social services funding. The ceiling is a fixed sum of money that represents the maximum federal support a territory may receive under specified funding streams, including TANF state grant funds, Title IV-E funding, and funding provided for assistance to aged, blind, and disabled individuals. Puerto Rico is the only territory with an approved Title IV-E plan. Its social services ceiling is fixed at $107,255,000 ( §§ 1108(a) and 1108(c) of the Social Security Act).
+
+ 
+ 
+ 
+ 65 .
+ 
+ 
+ The additional "indefinite budget authority" is usually limited to the latter part of the fiscal year and has been included in the annual Title IV-E program appropriations beginning with appropriations of FY2003.
+
+ 
+ 
+ 
+ 66 .
+ 
+ 
+ There is a standing announcement of the availability of these grants. None appear to have been awarded in FY2017. For FY2009-FY2016 grantees, see Tribal Title IV-E Plan Development grants awarded at http://www.acf.hhs.gov/programs/cb/resource/cb-discretionary-grant-awards .
+
+ 
+ 
+ 
+ 67 .
+ 
+ 
+ Funding for this center (expected to be between $2.5 million and $3.4 million annually for five years) was awarded to the Colorado Seminary in September 2014. Colorado Seminary owns and operates the University of Denver. See HHS-2014-ACF-ACYF-CZ-0815 at http://www.acf.hhs.gov/programs/cb/resource/cb-discretionary-grant-awards .
+
+ 
+ 
+ 
+ 68 .
+ 
+ 
+ For more information on this program see CRS Report RL34499, Youth Transitioning from Foster Care: Background and Federal Programs .
+
+ 
+ 
+ 
+ 69 .
+ 
+ 
+ For more information see CRS Report R43752, Child Welfare: Profiles of Current and Former Older Foster Youth Based on the National Youth in Transition Database (NYTD) . See also HHS, ACF, ACYF, Children's Bureau, NYTD Briefs at https://www.acf.hhs.gov/cb/resource/data-briefs .
+
+ 
+ 
+ 
+ 70 .
+ 
+ 
+ Tribes may be eligible to receive direct federal CFCIP funding, provided they have an approved Title IV-E plan or have an agreement with a state to provide Title IV-E foster care to tribal children in foster care.
+
+ 
+ 
+ 
+ 71 .
+ 
+ 
+ Section 111(c) of the Preventing Sex Trafficking and Strengthening Families Act ( P.L. 113-183 ).
+
+ 
+ 
+ 
+ 72 .
+ 
+ 
+ For purposes of the ETV program, the terms cost of attendance and institution of higher education are defined in Section 472 and Section 102, respectively, of the Higher Education Act. 
+
+ 
+ 
+ 
+ 73 .
+ 
+ 
+ CRS Report R43025, Child Welfare: The Adoption Incentive Program and Its Reauthorization , Tables C-1 and C-3.
+
+ 
+ 
+ 
+ 74 .
+ 
+ 
+ For FY2014, states earned payments based on a combination of the prior incentive structure and the incentive structure from P.L. 113-183 . Beginning with FY2015, all incentives were earned under that newer incentive structure. 
+
+ 
+ 
+ 
+ 75 .
+ 
+ 
+ For more information, see HHS, ACF, ACYF, Children's Bureau, Program Instruction (PI-15-08), July 8, 2015, http://www.acf.hhs.gov/cb/resource/pi1508 .
+
+ 
+ 
+ 
+ 76 .
+ 
+ 
+ Section 473A(e) and (f) of the Social Security Act.
+
+ 
+ 
+ 
+ 77 .
+ 
+ 
+ To see CAPTA with amendments through the CAPTA Reauthorization of 2010, see the HHS, ACF, ACYF, Children's Bureau website, http://www.acf.hhs.gov/sites/default/files/cb/capta2010.pdf . 
+
+ 
+ 
+ 
+ 78 .
+ 
+ 
+ Section 802, P.L. 114-22 , effective as of May 29, 2017. For purposes of the P.L. 114-22 amendments to CAPTA, states may define child as an individual who is not yet 24 years of age. 
+
+ 
+ 
+ 
+ 79 .
+ 
+ 
+ HHS, ACF, ACYF, Children's Bureau, Child Maltreatment 2015, January 2017.
+
+ 
+ 
+ 
+ 80 .
+ 
+ 
+ CRS calculation based on total CAPTA state grant funding for FY2017 ($25.3 million) divided by the number of CPS responses in FY2017 (2.2 million) = $11.50 per CPS response.
+
+ 
+ 
+ 
+ 81 .
+ 
+ 
+ Based on state plans for FY2014. For the remaining 11 CAPTA program improvement areas, between 12% and 46% of states reported plans to focus efforts on those areas. See HHS, ACF, ACYF, Children's Bureau, Report to Congress on the Effectiveness of CAPTA State Programs and Technical Assistance (second biennial report, submitted March 2015). 
+
+ 
+ 
+ 
+ 82 .
+ 
+ 
+ HHS provides an annual report based on these data, which are reported via the National Child Abuse and Neglect Data System (NCANDS). To view the FY2013 report (released in January 2015), or earlier reports, go to http://www.acf.hhs.gov/programs/cb/research-data-technology/statistics-research/child-maltreatment .
+
+ 
+ 
+ 
+ 83 .
+ 
+ 
+ This requirement was originally made via CAPTA's implementing regulations. However, the 1996 reauthorization of CAPTA ( P.L. 104-235 ) was interpreted as reducing the authority of HHS to regulate CAPTA and this, combined with subsequent statutory changes to CAPTA, led HHS to see the regulations as largely without force and increasingly moot. Ultimately it announced it was withdrawing all CAPTA regulations effective June 29, 2015. See Federal Register, March 30, 2015, pp. 16577-16579, https://www.gpo.gov/fdsys/pkg/FR-2015-03-30/pdf/2015-07238.pdf . 
+
+ 
+ 
+ 
+ 84 .
+ 
+ 
+ For a more complete list of changes see HHS, ACF, ACYF, Children's Bureau, IM-11-02, "CAPTA Reauthorization Act of 2010, February 15, 2011 https://www.acf.hhs.gov/sites/default/files/cb/im1102.pdf .
+
+ 
+ 
+ 
+ 85 .
+ 
+ 
+ Section 802 of P.L. 114-22 . For HHS/ACF guidance see ACYF-CB-IM-15-05, issued July 16, 2015, http://www.acf.hhs.gov/sites/default/files/cb/im1505.pdf . 
+
+ 
+ 
+ 
+ 86 .
+ 
+ 
+ Information received by CRS from HHS on June 20, 2017 regarding implementation status of child welfare program requirements related to sex trafficking.
+
+ 
+ 
+ 
+ 87 .
+ 
+ 
+ HHS, ACF, ACYF, Children's Bureau, Child Maltreatment 2015, p. 94. See also NCANDS Technical Bulletin No. 9, "Reporting Sex trafficking and Substance-Exposed Infants Data to NCANDS," May 2017.
+
+ 
+ 
+ 
+ 88 .
+ 
+ 
+ This requirement was added to the law in 2003 ( P.L. 108-36 ). Enacted in December 2010, P.L. 111-320 required health care providers to also notify CPS if a child was born and identified as affected by Fetal Alcohol Spectrum Disorder.
+
+ 
+ 
+ 
+ 89 .
+ 
+ 
+ Section 503 of P.L. 114-198 . For HHS/ACF description of the CARA provisions amending CAPTA, see ACYF-CB-IM-16-05, issued August 26, 2016, http://www.acf.hhs.gov/sites/default/files/cb/im1605.pdf . 
+
+ 
+ 
+ 
+ 90 .
+ 
+ 
+ For HHS/ACF program instructions on implementing the CARA amendments to CAPTA, see ACYF-CB-PI-17-02, issued January 17, 2017, https://www.acf.hhs.gov/sites/default/files/cb/pi1702.pdf .
+
+ 
+ 
+ 
+ 91 .
+ 
+ 
+ Information received by CRS from HHS, ACF, OLAB as of December 19, 2017. As of that date the 23 states with a PIP related to the CARA requirements in CAPTA are as follows: Alabama, Arkansas, Connecticut, Delaware, Idaho, Kentucky, Maryland, Massachusetts, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Vermont, and West Virginia . 
+
+ 
+
+ 
+ 
+ 
+ 92 .
+ 
+ 
+ P.L. 111-320 provides that in any year that total annual funding for CAPTA state grants exceeds the FY2009 appropriation level ($26,535,000) by at least $1 million, a minimum allotment (for each of the 50 states, the District of Columbia and Puerto Rico) must take effect. Specifically, if funding is greater than the FY2009 appropriation by at least $1 million but less than $2 million, then that minimum allotment equals $100,000; if it exceeds that appropriation by at least $2 million, but less than $3 million, then the minimum allotment equals $125,000; if it exceeds that appropriation by $3 million or more, then the minimum allotment equals $150,000.
+
+ 
+ 
+ 
+ 93 .
+ 
+ 
+ The law also authorizes HHS to create an advisory board on child abuse and neglect. The last such board created under CAPTA authority issued its final report in 1995.
+
+ 
+ 
+ 
+ 94 .
+ 
+ 
+ See HHS, ACF, ACYF, Children's Bureau, Report on Efforts to Coordinate Programs and Activities Related to Child Abuse and Neglect , January 31, 2014. In addition, for more on the Federal Interagency Workgroup on Child Abuse and Neglect, see http://www.acf.hhs.gov/programs/cb/resource/fediawg .
+
+ 
+ 
+ 
+ 95 .
+ 
+ 
+ The most recent Child Maltreatment report (including data for FY2015) and reports from earlier years are available online at http://www.acf.hhs.gov/programs/cb/research-data-technology/statistics-research/child-maltreatment . 
+
+ 
+ 
+ 
+ 96 .
+ 
+ 
+ The Design Options Project ( http://www.acf.hhs.gov/opre/research/project/design-options-for-understanding-child-maltreatment-incidence-2015-2017 ) is expected to propose a replacement for the National Incidence Survey (NIS), which was first developed in the 1970s and has been fielded on four occasions ( http://www.acf.hhs.gov/opre/research/project/national-incidence-study-of-child-abuse-and-neglect-nis-4-2004-2009 ).
+
+ 
+ 
+ 
+ 97 .
+ 
+ 
+ Section 114A of the Social Security Act (42 U.S.C. §1314b), added by the Preventing Sex Trafficking and Increasing Adoptions Act of 2014, directed HHS to establish this committee but did not provide funding for that purpose.
+
+ 
+ 
+ 
+ 98 .
+ 
+ 
+ Explanatory statement accompanying the final funding for FY2014 ( P.L. 113-76 ), included in Congressional Record, January 15, 2014, H1041.
+
+ 
+ 
+ 
+ 99 .
+ 
+ 
+ Section 204(4) of CAPTA.
+
+ 
+ 
+ 
+ 100 .
+ 
+ 
+ The statute provides that no state may receive less than $175,000. Beginning with FY2005 (after an increase in appropriations provided for the program) HHS has ensured that each state receives a minimum allotment of $200,000. 
+
+ 
+ 
+ 
+ 101 .
+ 
+ 
+ Children's Justice Act funding is made available, separately, to tribes for related purposes. This funding is administered by DOJ. See http://www.justice.gov/jmd/file/822366/download#page=65 .
+
+ 
+ 
+ 
+ 102 .
+ 
+ 
+ For more information about this fund, see CRS Report R42672, The Crime Victims Fund: Federal Support for Victims of Crime .
+
+ 
+ 
+ 
+ 103 .
+ 
+ 
+ There is not a formula for distribution in the statute. HHS provides each state and Puerto Rico a base allotment of $50,000 and distributes the remaining funds based on a jurisdiction's relative share of the national population of children (individuals under 18 years of age).
+
+ 
+ 
+ 
+ 104 .
+ 
+ 
+ The provisions requiring specified related to reporting are at 42 U.S.C. § 13031 and 18 U.S.C. § 2258 ; those concerning background checks are at 42 U.S.C. § 13041 ; there is no funding associated with these provisions, and they are not discussed further in this report.
+
+ 
+ 
+ 
+ 105 .
+ 
+ 
+ 42 U.S.C. §§13001, 13001a, 13001b, 13002, and 13003.
+
+ 
+ 
+ 
+ 106 .
+ 
+ 
+ National Children's Alliance, Healing Justice and Trust: Measuring Children's Outcomes, two-page brief available at http://www.nationalchildrensalliance.org/sites/default/files/downloads/OMS-Measuring-Outcomes-Brief-2015.pdf . For coverage by specific state, see the CAC maps at http://www.nationalchildrensalliance.org/cac-coverage-maps .
+
+ 
+ 
+ 
+ 107 .
+ 
+ 
+ National Children's Alliance, "NCA National Statistic- Statistical Report, 2015," February 19, 2017, http://www.nationalchildrensalliance.org/sites/default/files/2016NationalAnnual.pdf 
+
+ 
+ 
+ 
+ 108 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 109 .
+ 
+ 
+ Section 104 of P.L. 114-22 . See also CRS Report R44315, Justice for Victims of Trafficking Act of 2015: Changes to Domestic Human Trafficking Policies .
+
+ 
+ 
+ 
+ 110 .
+ 
+ 
+ Section 101 of P.L. 114-22 . The act requires no less than $2 million annually to be devoted to grants related to victims of child pornography, provided this amount is available from certain dollars that are to be transferred to the fund.
+
+ 
+ 
+ 
+ 111 .
+ 
+ 
+ For more information on the National Children's Alliance support for local and state CACs, see http://www.nationalchildrensalliance.org/funding-cacs-chapters .
+
+ 
+ 
+ 
+ 112 .
+ 
+ 
+ Support for community-based "multidisciplinary" responses to child abuse and neglect cases was included in the original 1990 Victims of Child Abuse Act. However, the term "children's advocacy centers" and the requirement for regional children's advocacy centers were not added to the act until 1992 (as part of legislation primarily designed to reauthorize the Juvenile Justice and Delinquency Prevention Act and enacted as P.L. 102-586 ). 
+
+ 
+ 
+ 
+ 113 .
+ 
+ 
+ For links to regional CAC websites, see http://www.mrcac.org/about-mrcac/our-partners/ .
+
+ 
+ 
+ 
+ 114 .
+ 
+ 
+ For more information about NCPCA, see http://www.ndaa.org/ncpca.html .
+
+ 
+ 
+ 
+ 115 .
+ 
+ 
+ P.L. 113-163 was titled the Victims of Child Abuse Act Reauthorization Act; however, it reauthorized only Subtitle A of that act.
+
+ 
+ 
+ 
+ 116 .
+ 
+ 
+ S.Rept. 114-239 , pp. 92-93. This report accompanied the FY2017 appropriations language for DOJ approved by the Senate in the 114 th Congress; according to the Explanatory Statement accompany the bill that became final FY2017 appropriations act (enacted as P.L. 115-31 ) the agency is to be guided by such report language (to extent differing instructions are not included in the final legislation or explanatory statement).
+
+ 
+ 
+ 
+ 117 .
+ 
+ 
+ 42 U.S.C. §§13011, 13012, 13013, 13013a, and 13014.
+
+ 
+ 
+ 
+ 118 .
+ 
+ 
+ Department of Justice, Office of the Inspector General, National Court-Appointed Special Advocate Program , Audit Report 07-04, December 2006, Executive Summary, http://www.justice.gov/oig/reports/OJP/a0704/exec.htm/ .
+
+ 
+ 
+ 
+ 119 .
+ 
+ 
+ Ibid. According to the 2006 DOJ, OIG report, North Dakota uses paid advocates and is the only state that does not have a member CASA organization. See also information at http://www.casaforchildren.org/ . 
+
+ 
+ 
+ 
+ 120 .
+ 
+ 
+ Section 4(b)(2) of CAPTA ( P.L. 93-247 , 1974) required states receiving certain funds under the act to provide a guardian ad litem in every case involving a victim of child abuse or neglect that resulted in judicial proceedings. Current law requires states to assure they have a statewide program for appointment of an appropriately trained CASA or guardian ad litem in each such case. (Section106(b)(2)(B)(xiii) of CAPTA (42 U.S.C. §5106a(b)(2)(B)(xiii)).
+
+ 
+ 
+ 
+ 121 .
+ 
+ 
+ See Findings as included in Subchapter B, Victims of Child Abuse Act of 1990 (Title II of P.L. 101-647 ). 
+
+ 
+ 
+ 
+ 122 .
+ 
+ 
+ See NCASAA, 2015 National CASA Annual Report , http://nc.casaforchildren.org/apps/annualreport2015/index.html .
+
+ 
+ 
+ 
+ 123 .
+ 
+ 
+ 42 U.S.C. §§13021, 13022, 13023, and 13024.
+
+ 
+ 
+ 
+ 124 .
+ 
+ 
+ The act also authorizes grants to be made to state courts for training and technical assistance of judges and attorneys in juvenile and family courts. No funds have been appropriated for this purpose under this authority. However, in 1993 ( P.L. 103-66 ) Congress established the Court Improvement Program (CIP), which is administered by HHS and provides mandatory grants to the highest court in each state to improve its handling of child welfare, including child abuse and neglect, proceedings. The statutory authority for CIP is included at Section 438 of the Social Security Act.
+
+ 
+ 
+ 
+ 125 .
+ 
+ 
+ Most model court initiatives operate in a single court, but at least two operate on a statewide level. For more information, see http://www.ncjfcj.org/our-work/model-courts .
+
+ 
+ 
+ 
+ 126 .
+ 
+ 
+ Title II of the Child Abuse Prevention and Treatment and Adoption Reform Act of 1978 ( P.L. 95-266 ). Title I of the 1978 law reauthorized funding for CAPTA, and funding for Adoption Opportunities is traditionally extended as part of legislation that also extends funding authority for CAPTA.
+
+ 
+ 
+ 
+ 127 .
+ 
+ 
+ 42 U.S.C. §§5111, 5113, 5114, and 5115. 
+
+ 
+ 
+ 
+ 128 .
+ 
+ 
+ Beginning with 2011, funding that had been provided for "Adoption Awareness" (Sections 330F and 330G of the Public Health Service Act, as added by the Children's Health Act of 2000) was combined with Adoption Opportunities funding. The Obama Administration sought this consolidation of funding, noting that where the Adoption Awareness program was "more narrowly targeted," the Adoption Opportunities program granted "broad authority" to support adoption projects, including projects similar to those supported by Adoption Awareness. It further argued that "consolidating these funds will provide a more efficient mechanism for financing on-going projects." See HHS, ACF, Justification of Estimates for Appropriations Committees, FY2011 (2010), p. 150.
+
+ 
+ 
+ 
+ 129 .
+ 
+ 
+ HHS, ACF, Justification of Estimates for Appropriations Committees, FY2017 (February 2016), p. 162.
+
+ 
+ 
+ 
+ 130 .
+ 
+ 
+ Ibid. "Supporting Permanent Placements of Children in Foster Care Through Electronic Data Exchange" for the American Public Human Services Association (APHSA) by Walter R McDonald & Associates (WRMA). See also the NEICE project website at http://www.aphsa.org/content/AAICPC/en/actions/NEICE.html , including national implementation map.
+
+ 
+ 
+ 
+ 131 .
+ 
+ 
+ S.Rept. 114-274 , p. 141. See also Explanatory Statement included in Cong. Record, May 3, 2017, H3949, which notes that this report language (where not superseded by language in the Explanatory Statement) is to guide agency action, and is to be treated with same emphasis as language included in the Explanatory Statement. 
+
+ 
+ 
+ 
+ 132 .
+ 
+ 
+ 42 U.S.C. §5117aa, §5117a-11, §5117aa-12, §5117aa-21, §5117aa-22.
+
+ 
+ 
+ 
+ 133 .
+ 
+ 
+ The center's former website, http://aia.berkeley.edu , directs readers to its YouTube channel, which remains online.
+
+ 
+ 
+ 
+ 134 .
+ 
+ 
+ HHS, Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau, Report to Congress: 2006 National Estimates of the Number of Boarder Babies, Abandoned Infants, Discarded Infants, and Infant Homicides, James Bell Associates, transmitted to Congress May 31, 2011. 
+
+ 
+ 
+ 
+ 135 .
+ 
+ 
+ For information about early implementation efforts, see National AIA Resource Center, Substance Exposed Infants: Noteworthy Policy and Practices, Issue Brief 3, September 2006.
+
+ 
+ 
+ 
+ 136 .
+ 
+ 
+ HHS, ACF, Justification of Estimates for the Appropriations Committees, FY2016 (2015), p. 165. As part of this request, the Administration sought to rename the program "Protecting Abandoned and At Risk Infants and Toddlers." 
+
+ 
+ 
+ 
+ 137 .
+ 
+ 
+ S.Rept. 114-74 , to accompany S. 1695, which was incorporated into the explanatory statement accompanying the legislation ( H.R. 2029 ) that became the final FY2016 appropriations act ( P.L. 114-113 ).
+
+ 
+ 
+ 
+ 138 .
+ 
+ 
+ See CRS Report R42050, Budget "Sequestration" and Selected Program Exemptions and Special Rules .
+
+ 
+ 
+ 
+ 139 .
+ 
+ 
+ As enacted in 2011, the Budget Control Act (BCA, P.L. 112-25 ) required sequestration of mandatory funding in each of FY2013-FY2021 (absent congressional action to reduce this spending in some other ways). Prior to the December 2015 budget bill, the BCA was amended to extend that time period through FY2023 by the Bipartisan Budget Act of 2013 (Div. A., P.L. 113-67 ) and through FY2024 by the Temporary Debt Limit Extension ( P.L. 113-83 ).
+
+ 
+ 
+ 
+ 140 .
+ 
+ 
+ Tribes may seek approval of plans at any time, and readers may want to consult the "Tribes with Approved Title IV-E Plans" web page available on the Children's Bureau website for updates, http://www.acf.hhs.gov/cb/resource/tribes-with-approved-title-iv-e-plans . 
+
+ 
+ 
+ 
+ 141 .
+ 
+ 
+ Information received by CRS from HHS/ACF/Children's Bureau, as of April 3, 2017. In addition to the listed jurisdictions, some states provide comparable assistance for older foster youth using their own or other (non-Title IV-E) federal funds.
+
+ 
+ 
+ 
+ 142 .
+ 
+ 
+ Illinois is included in this group because a portion of its current waiver project predates FY2012. However, the project current authorized includes new components and its implementation date is in 2013. Oregon operated a waiver project prior to FY2012. However, it is not listed here because its current waiver project was initiated in whole, in 2015.
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+link to page 1 
+
+ 
+
+ 
+ 
+
+October 18, 2019
+
+ Trafficking in Persons: Child Protection Compacts 
+
+ Introduction 
+
+appropriations, with the exception of FY2015, when CPC 
+
+Child Protection Compacts (CPCs) are bilateral, multiyear 
+
+funding was included as part of a larger $12 million 
+
+foreign assistance packages designed to combat child 
+
+directive for the TIP Office. 
+
+trafficking. Authorized by Congress in 2013, CPCs are one 
+of several international anti-trafficking programs 
+
+ Selection and Implementation 
+
+administered by the U.S. Department of State’s Office to 
+
+Through VAWA 2013, Congress authorized the selection of 
+
+Monitor and Combat Trafficking in Persons (TIP Office). 
+
+CPC countries according to criteria set by the Secretary of 
+
+CPCs are unique among anti-trafficking programs in their 
+
+State in consultation with the Secretary of Labor and the 
+
+focus on child trafficking, which encompasses forms of 
+
+Administrator of the U.S. Agency for International 
+
+forced and bonded labor, including forced begging, the 
+
+Development (USAID). These criteria are to include a high 
+
+prostitution of minors, and the recruitment and use of child 
+
+prevalence of child trafficking and a commitment to address 
+
+soldiers. To date, the United States has established four 
+
+the issue on the part of the partner government. In 
+
+CPCs ( Figure 1 ) . 
+
+determining partner country eligibility, the TIP Office 
+considers information from its annual reports, as well as 
+
+CPCs, referred to by the U.S. Department of State as CPC 
+
+each country’s national action plans relating to human 
+
+“Partnerships,” align with the U.S. government’s broader 
+
+trafficking. (For more on the TIP report’s ranking of 
+
+“3P” paradigm to combat severe forms of trafficking in 
+
+countries’ anti-trafficking efforts, see CRS Report R44953, 
+
+persons through the prosecution of traffickers, protection of 
+
+ The State Department’s Trafficking in Persons Report: 
+
+victims, and prevention of trafficking. In 2009, the State 
+
+ Scope, Aid Restrictions, and Methodology .) 
+
+Department added a fourth “P” to the 3Ps, to include 
+ partnerships . Reflecting shared political will to combat 
+
+State Department officials work with foreign authorities to 
+
+child trafficking, CPCs also involve financial or other 
+
+develop the CPC partnership agreement. According to 
+
+commitments from host nations. 
+
+VAWA 2013, U.S. assistance may take “the form of grants, 
+cooperative agreements, or contracts with national 
+
+ Origins 
+
+governments, regional or local governmental units, or non-
+
+Legislative initiatives to establish CPCs were first 
+
+governmental organizations or private entities.” CPCs may 
+
+introduced in the 111th Congress (H.R. 2737 and S. 3184). 
+
+be terminated if a country engages in activities counter to 
+
+The concept drew in part from the experiences of the 
+
+the United States’ national security interest or inconsistent 
+
+Millennium Challenge Corporation, which uses bilateral, 
+
+with the criteria that made it eligible for the CPC, or has 
+
+government-to-government “compacts” to advance 
+
+failed to fulfill its CPC commitments. 
+
+economic development. The concept also reflected a 
+broader U.S. government approach to foreign assistance, 
+
+ Figure 1. CPC Duration and Initial Funding 
+
+which incentivizes shared commitments and buy-in among 
+stakeholders. Adopting a similar approach, CPCs involve 
+collaboration with the host government, civil society, and 
+private sector to design targeted aid packages to address 
+context-specific child trafficking challenges. 
+
+Authorization for CPCs was ultimately enacted in the 
+Violence Against Women Reauthorization Act (VAWA) of 
+2013 (P.L. 113-4; 22 U.S.C. 7103a). Section 1202 of that 
+act stated that the CPCs would 
+ prevent and respond to violence, exploitation, and abuse 
+
+ 
+
+against children, and 
+
+ Source: U.S. Department of State, “Child Protection Compact 
+
+
+
+Partnerships,” adapted by CRS Graphics. 
+
+ measurably reduce the trafficking of minors by building 
+
+ Note: Subsequent, additional funding noted in country narratives. 
+
+sustainable and effective systems of justice, prevention, 
+and protection. 
+
+ Country Compacts 
+
+CPCs were first funded in the Consolidated Appropriations 
+
+The four CPCs to date have been funded in the range of 
+
+Act, 2014 (P.L. 113-76), which directed that $5 million in 
+
+$3.5-5 million, with a time frame of four to five years. 
+
+International Narcotics Control and Law Enforcement 
+
+Selected countries have been identified as experiencing 
+
+(INCLE) assistance be used for this purpose. In years since, 
+
+issues relating to child trafficking by the annual TIP reports. 
+
+$5 million has typically been directed for CPCs in annual 
+
+Partner governments have demonstrated varying levels of 
+interest and success in addressing these issues, as reflected 
+
+https://crsreports.congress.gov 
+
+ 
+ Trafficking in Persons: Child Protection Compacts 
+
+by the range of TIP rankings they have received. While P.L. 
+
+scale gold mining, signed in February 2017. In October 
+
+113-4 does permit providing aid directly to the foreign 
+
+2017, the TIP Office awarded $5 million (the amount 
+
+government, in practice, funding has always been awarded 
+
+specified in the agreement) to the International Labor 
+
+to nongovernmental implementing partners. 
+
+Organization and Centro Yanapanakusun, a local 
+nongovernmental organization (NGO), for CPC activities. 
+
+ Ghana 
+
+The Government of Peru stated its intention to provide at 
+
+The United States and Ghana partnered to address child 
+
+least 8 million soles (approximately U.S. $2.4 million) and 
+
+labor in the Ghanaian cocoa industry in the years leading to 
+
+to dedicate more personnel to its Multisectoral Commission 
+
+the CPC. This working relationship provided a foundation 
+
+Against Trafficking in Persons and Smuggling of Migrants. 
+
+for the first-ever CPC in June 2015. According to the five-
+year agreement, the United States intended to provide 
+
+ Status. Peru has maintained its Tier 2 ranking on the TIP 
+
+“direct financial support” to nongovernmental 
+
+Report since 2017. The State Department’s 2018 human 
+
+implementing partners. This CPC is the only CPC that did 
+
+rights report found that children remained “in the worst 
+
+not include a specific intended financial contribution on the 
+
+forms of child labor, including … in commercial sexual 
+
+part of the United States. The Government of Ghana also 
+
+exploitation, sometimes as a result of human trafficking.” 
+
+did not commit to a specific financial contribution, but it 
+did pledge to increase the budget of relevant ministries and 
+
+ Jamaica 
+
+establish a CPC technical committee, among other 
+
+Signed in May 2018, Peru’s CPC agreement stated the TIP 
+
+commitments. In October 2015, the TIP Office awarded $5 
+
+Office’s intention to provide $4.5 million over four years, 
+
+million to the U.N. International Organization for Migration 
+
+but the office subsequently awarded $5 million to IOM, the 
+
+(IOM) and Free the Slaves for CPC activities in Ghana. The 
+
+Warnath Group, and Winrock International for CPC 
+
+TIP Office plans to provide an additional $1.3 million to 
+
+activities. Jamaica did not commit to a specific financial 
+
+extend activities to early 2020. 
+
+support for CPC activities, but it agreed to dedicate 
+“appropriate” staff and financial resources and to ensure the 
+
+ Status. Ghana’s ranking in the TIP Report has improved 
+
+cooperation of relevant government offices. 
+
+over the course of its CPC—moving from the Tier 2 Watch 
+List in 2015 to Tier 2 in 2018 and 2019. A Tier 2 ranking 
+
+ Status. Jamaica has remained at a Tier 2 ranking in the TIP 
+
+indicates that Ghana does not meet the minimum standards 
+
+Report since the beginning of the CPC. The State 
+
+for eliminating severe forms of human trafficking, but that 
+
+Department’s 2018 human rights report found that 
+
+it is making significant efforts to do so. The TIP Office 
+
+commercial sexual exploitation was prevalent and that 
+
+conducted a midline evaluation of the CPC in September 
+
+children were “victims of forced labor in domestic work.” 
+
+2018. Despite some improvements (more investigations, 
+greater public awareness), CPC programming faced 
+
+ Mongolia 
+
+challenges, including delays, understaffing, limited 
+
+On August 26, 2019, the State Department announced that 
+
+resources, bureaucratic reluctance, and cultural acceptance 
+
+it had begun negotiations for a CPC with the Government 
+
+of child labor. 
+
+of Mongolia. Mongolia was upgraded from the Tier 2 
+Watch List to Tier 2 on the 2019 TIP report. 
+
+ The Philippines 
+ In April 2017, the United States entered into a four-year 
+
+ Policy Issues 
+
+CPC with the Philippines. In April 2017, the TIP Office 
+
+For FY2020, the Department of State, Foreign Operations, 
+
+awarded $3.5 million (the amount specified in the 
+
+and Related Programs Appropriations Act (S. 2583) would 
+
+agreement) to the International Justice Mission and the 
+
+continue funding CPCs at $5 million. The accompanying 
+
+Salvation Army in support of the CPC. The Philippines has 
+
+committee report (S.Rept. 116-126 ) recommended that 
+
+committed to providing 40 million Philippine pesos 
+
+funds “be prioritized for countries with the greatest need.” 
+
+(approximately U.S. $800,000) and additional staffing and 
+
+As Congress conducts oversight of anti-trafficking 
+
+other resources in support of CPC activities. 
+
+programs and considers funding new CPCs, it may consider 
+the following issues: 
+
+ Status. The Philippines has maintained a Tier 1 ranking in 
+
+ The effectiveness of these programs in combating child 
+
+the TIP Report since 2016, indicating that it meets the 
+
+trafficking—and whether additional compacts are 
+
+minimum standards for eliminating severe forms of 
+
+warranted. 
+
+trafficking in persons. However, some advocates have 
+objected to its Tier 1 ranking, due to the prevalence of 
+
+ Whether CPC countries have been selected for the 
+
+domestic sex trafficking and vulnerability of Filipino 
+
+“greatest need” of anti-trafficking support. 
+
+migrant workers. The State Department’s 2018 human 
+
+ 
+
+rights report notes that the Philippines is a “top global 
+
+Whether the partner government commitment criteria in 
+
+internet source of online child pornography,” and that 
+
+VAWA 2013 are being applied. 
+
+“child labor remained a widespread problem.” 
+
+ How CPC objectives differ from those of other anti-
+
+trafficking programs. 
+
+ Peru 
+
+
+
+In June 2017, the United States entered into a four-year 
+
+ Whether the objectives are realistic given typical 
+
+CPC with Peru. Announcement of the CPC followed recent 
+
+funding levels. 
+
+bilateral efforts to address trafficking in Peru, including a 
+
+ Katarina C. O'Regan , Analyst in Foreign Policy 
+
+memorandum of understanding (MOU) concerning small-
+
+https://crsreports.congress.gov 
+
+ 
+ Trafficking in Persons: Child Protection Compacts 
+
+ 
+
+ IF11337 
+
+ 
+
+ 
+
+ Disclaimer 
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to 
+congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. 
+Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has 
+been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the 
+United States Government, are not subject to copyright protection in the United States. Any CRS Report may be 
+reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include 
+copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you 
+wish to copy or otherwise use copyrighted material. 
+
+ 
+
+ https://crsreports.congress.gov | IF11337 · VERSION 1 · NEW
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+Order Code RL32049
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ Reintroduction of the 30-Year Treasury Bond: 
+
+ An Economic Analysis 
+
+ Updated August 8, 2005 
+
+Marc Labonte
+
+Specialist in Macroeconomics
+
+Government and Finance Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ Reintroduction of the 30-Year Treasury Bond:
+
+ An Economic Analysis
+
+ Summary 
+
+Facing projections of burgeoning surpluses, the Treasury decided to stop issuing
+
+the 30-year bond in 2001. It was reasoned at the time that the government would not
+need to borrow long-term when it planned to retire the entire publicly held national
+debt within a few years. Since then, the projections of large surpluses have been
+transformed into large deficits. On August 3, 2005, the Treasury announced that the
+30-year bond would be reintroduced in the first quarter of 2006. To evaluate the
+merits of this change, it is useful to consider how the reintroduction of the 30-year
+bond would affect the cost of government borrowing, the macroeconomy, and
+financial market efficiency.
+
+Reintroduction of the 30-year bond could reduce government borrowing costs,
+
+but the circumstances under which 30-year bonds would be less costly than shorter-
+term debt would be rare. The government could lower its interest costs only when
+the yield on 30-year bonds is lower than the yield on present and expected future
+yields on shorter-term debt. This occurs infrequently because when long-term rates
+fall, short-term rates typically fall even further. Actively changing borrowing
+patterns to reduce interest costs would be a departure from current Treasury debt
+management policy and would run counter to its goal of promoting efficient financial
+markets. Reintroduction of the 30-year Treasury bond would not be expected to have
+any significant effect on the macroeconomy. Economic theory suggests that
+government budget deficits have important effects on economic growth and interest
+rates, but there is thought to be little significance to the maturity at which the debt is
+financed.
+
+U.S. Treasuries are important to the functioning of the financial system through
+
+their roles as a benchmark security and a safe haven. The benchmark role refers to
+the tendency of the financial sector to use U.S. Treasuries to price other financial
+securities and as collateral in other financial instruments. The safe haven role refers
+to the large capital flows into Treasuries at times of financial unrest. The effect of
+reintroducing the 30-year Treasury bond on financial efficiency revolves around
+whether it would enhance the benchmark and safe haven role. Treasuries serve these
+roles effectively because they are highly liquid and predictable. Reintroducing the
+30-year bond would reduce the liquidity and predictability of other Treasury
+securities only if future budget deficits are small. Before its discontinuation, the 30-
+year Treasury bond served in the benchmark role; since its retirement, it has been
+replaced by the 10-year Treasury note. 
+
+The government borrows across many maturities to neutralize the effect on
+
+private borrowing patterns. If the government borrowed disproportionately at the
+short or long end of the market, it could force private borrowers out of that end.
+Reintroduction of the 30-year bond would enhance the government’s neutrality with
+respect to maturity length. Some also argue that the private supply for very long-term
+debt falls short of private demand, which is driven by institutions such as banks,
+insurance companies, and pension funds. Reintroduction of the 30-year bond could
+fill that gap. This report will not be updated.
+
+ 
+ Contents 
+
+The Goals of Treasury Debt Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Effect on the Federal Government’s Finances . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Effect on the Macroeconomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+Effect on Financial Markets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+
+(1) Role of Treasuries as Benchmark . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
+(2) Role of Treasuries as Safe Haven . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
+Effect on Neutrality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Effect on Liquidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+Effect on Predictability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+
+Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+
+ List of Figures 
+
+Figure 1. Example of a Shift in the Yield Curve . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Figure 2. Example of a Change in the Slope of the Yield Curve . . . . . . . . . . . . . 3
+
+ List of Tables 
+
+Table 1. Corporate Issuance By Maturity Length . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+ 
+ Reintroduction of the 30-Year Treasury
+
+Bond: An Economic Analysis
+
+The history of 30-year Treasury bonds stretches back to World War I. In the
+
+post-World War II era, the Treasury began to issue 30-year bonds in 1977. In the
+decades before 1977, long-term federal government borrowing was limited by
+mandated interest rate ceilings that were often lower than market rates. After the
+repeal of interest rate ceilings, the issuance by the Treasury of 30-year bonds and
+other long-term bonds increased rapidly in the 1980s along with the growth in the
+budget deficit. 
+
+New issues of the 30-year Treasury bond were discontinued in November 2001
+
+based on budget projections at the time that the publicly held national debt would be
+retired within a matter of years.1 It was reasoned at the time that it would not be in
+the nation’s interest to issue debt that would still be outstanding after the national
+debt had been retired and the budget had entered a period of sustained surplus. The
+drawbacks to discontinuing the 30-year bond were seen to be insignificant. The
+Treasury also discontinued other maturities, such as the 20-year bond and the 3-year
+note, in the surplus years in order to increase liquidity in the remaining maturities as
+borrowing needs dwindled. 
+
+Since then, the projections of large surpluses have been transformed into large
+
+deficits. On August 3, 2005, the Treasury announced that the 30-year bond would
+be reintroduced in the first quarter of 2006.2 To evaluate the merits of this change,
+it is useful to consider how the reintroduction of the 30-year bond would affect the
+cost of government borrowing, the macroeconomy, and the efficiency of financial
+markets. Before doing so, it is useful to define the goals of Treasury debt
+management.
+
+ The Goals of Treasury Debt Management 
+
+The federal government currently borrows across the yield curve, from bills that
+
+mature in three months to notes that mature in 10 years. In 2004, the average length
+
+1 Although the government stopped issuing new 30-year Treasuries, the effort to retire
+outstanding 30-year Treasuries prematurely was limited. At the time the 30-year program
+was discontinued, the last outstanding 30-year bond would have matured in 2032.
+
+2 U.S. Department of Treasury, “August 2005 Quarterly Refunding Statement,” press release
+js-2671, Aug. 3, 2005.
+
+ 
+ CRS-2
+
+of maturity on outstanding Treasuries was 4 years and 11 months.3 The Treasury
+identifies three major principles guiding its debt management decisions:
+
+(1) to provide sound cash management in order to ensure that adequate
+cash balances are available at all times;
+(2) to achieve the lowest cost financing for the taxpayers; and
+(3) to promote efficient capital markets.4
+
+At times these principles are mutually compatible; at others they conflict with
+
+one another. For example, issuing long-term bonds helps the government achieve the
+first goal because it adds predictability to its revenues by reducing the uncertainty of
+future interest costs. But it will often raise interest costs to the taxpayer. While the
+reintroduction of the 30-year Treasury bond would increase predictability, it is
+arguable whether sufficient predictability cannot already be achieved with 5-year and
+10-year securities. The remainder of the report will explore the effects of the
+reintroduction of the 30-year bond on the other two goals of Treasury debt
+management and its macroeconomic effects.
+
+ Effect on the Federal Government’s Finances 
+
+Reducing interest costs frees up government revenues for lower taxes or higher
+
+government spending. Issuing 30-year bonds could reduce interest costs to the
+government when long-term rates are low both in absolute terms and relative to
+short-term rates. To determine whether 30-year bonds will lower interest costs, it is
+necessary to compare their yields not only to short-term yields today, but also to
+expected future short-term yields. The alternative to issuing a long-term bond is to
+issue a short-term security and continue to roll it over into new short-term securities
+as it matures. Thus, long-term bonds are financially preferable to short-term
+securities only if long-term rates are lower than the (discounted) sum of current and
+future short-term rates. This is most likely to be the case when the yield curve shifts
+down and flattens; but it is rare for both to happen simultaneously. 
+
+To understand why this is true, it is necessary to understand movements in the
+
+yield curve. The yield curve is a plot of interest rates by maturity. Typically, it is
+sloping upward, such that long-term rates are higher than short-term rates. Thus,
+when an interest rate of any given maturity changes, there can be two sources of the
+change: a shift of the yield curve (with no change in slope), as shown in Figure 1 , or
+a change in the slope of the yield curve, as shown in Figure 2 . As economic
+conditions improve, the yield curve tends to both shift upward (so interest rates are
+higher at all maturities) and flatten (so that the difference between short term and
+long term rates diminishes), all else equal. It is common for the yield curve to
+become inverted (long-term rates are lower than short-term rates) at relatively high
+
+3 U.S. Department of Treasury, Treasury Bulletin , June 2005, Table FD-5.
+
+4 Testimony by Treasury Assistant Secretary Lee Sachs before the House Committee on
+Ways and Means, Sept. 28, 1999. These principles have not been changed by the current
+Administration.
+
+ 
+ CRS-3
+
+interest rates directly before a recession begins. By contrast, rates are typically low
+(i.e., the yield curve has shifted downward) when the yield curve is relatively steep.5
+
+ Figure 1. Example of a Shift in the 
+
+ Figure 2. Example of a Change in 
+
+ Yield Curve 
+
+ the Slope of the Yield Curve 
+
+Yield
+
+Yield
+
+Maturity Length (Years)
+
+Maturity Length (Years)
+
+This suggests that the reintroduction of the 30-year bond could lower interest
+
+costs in rare instances if the government aggressively pursued a cost-minimizing
+strategy. The Treasury does not currently pursue such a strategy, however, because
+it would undermine the other two principles of debt management.6 As will be
+discussed below, the other goals of debt management rely on maintaining neutrality,
+predictability, and liquidity. Pursuit of these goals inhibits the Treasury from
+exploiting movements in the yield curve through changes in issuance patterns.
+Undoubtedly this leads to higher interest costs in the short run. But some argue that
+pursuing an aggressive least-cost strategy would not necessarily lower borrowing
+costs in the long term. U.S. Treasuries have lower interest rates than any other asset
+because they are perceived as safer than any other asset. Part of this safety derives
+from their predictability and liquidity, and were these features to be reduced by
+erratic and idiosyncratic issuance patterns, Treasuries would be less desirable to
+investors, who would therefore demand higher yields to hold them. Borrowing
+across the yield curve may also extend the appeal of Treasury securities to a broader
+
+5 This relationship is borne out in the data: from 1977 to 2002, the annual correlation
+between 30-year Treasury yields and the spread between 10-year Treasury yields and 30-
+year yields was -0.72.
+
+6 The last time the Treasury made a major change in borrowing patterns to lower interest
+costs was 1993, when 45% of its long-term financing was shifted to short-term securities.
+However, this was done at a time when long-term interest rates were at their lowest nominal
+level in 16 years. This was a one-time shift in policy toward shorter maturities, and
+borrowing patterns were not continuously altered to take advantage of subsequent
+movements in interest rates. See “Treasury Shift Toward Short-Term a Bet on Future
+Rates,” Christian Science Monitor , May10, 1993; Thomas Watterson, “Treasury Plan a
+Negative in Long Term,” Boston Globe , May 10, 1993, p. 11; “Big Change in Treasury
+Sales,” San Francisco Chronicle , May 6, 1993, p. C1.
+
+ 
+ CRS-4
+
+class of investors, increasing demand for U.S. Treasuries and, hence, lowering their
+interest costs.7
+
+From a debt management perspective, the Treasury is concerned not only with
+
+minimizing the cost of interest payments, but also with minimizing the risks
+associated with uncertain interest payments. For example, if the Treasury borrowed
+exclusively on a short-term basis, its average cost over time would be lower, but the
+volatility of its interest payments would be higher. This would lead to larger income
+transfers from taxpayers to bond owners in years when interest rates are high, and
+smaller transfers in years when rates are low. Borrowing on a longer-term basis
+reduces interest payment volatility by locking in a given interest rate over the life of
+the bond, smoothing the transfers from taxpayers to bondholders over time. Issuing
+30-year bonds again would increase the Treasury’s ability to smooth interest
+payments over time.8
+
+The argument, explained below, that interest payments are not burdensome to
+
+the economy as a whole since “we owe it to ourselves” suggests that there is no
+economic rationale for the goal of minimizing interest payments on domestically held
+debt through variable issuance strategies. However, a valid economic argument can
+be made in favor of minimizing interest payments for the portion of the national debt
+owned by foreigners.
+
+There is also the issue of whether the reintroduction of the 30-year bond would
+
+impose one-time administrative costs on the Treasury. At the time of its
+discontinuation, Treasury Undersecretary Peter Fisher said that the 30-year bond
+could be reintroduced “at no cost to the Treasury.”9 Since there are administrative
+costs associated with every bond issuance, rolling over short-term bonds, in general,
+entails higher administrative costs than issuing long-term bonds; however,
+administrative costs are tiny compared to the amounts borrowed.
+
+ Effect on the Macroeconomy 
+
+Economic theory suggests a clear effect of the budget balance on the economy.10
+
+In the short run, budget deficits may stimulate aggregate spending in the economy,
+particularly if the economy is in a recession. In the long run, deficits reduce the
+sustainable rate of growth by “crowding out” private investment, all else equal.11 This
+reduces U.S. living standards in the long run from what they otherwise would be. 
+
+7 Testimony by Treasury Assistant Secretary Gary Gensler before the House Committee on
+Ways and Means, June 23, 1998.
+
+8 Professor John Campbell, “Testimony before the Committee on Ways and Means,” June
+24, 1998.
+
+9 John Berry, “Treasury to Stop 30-Year Bond Sales,” Washington Post , Nov. 1, 2001, p. E1.
+
+10 See CRS Report RL31235, The Economics of the Federal Budget Deficit, by Brian
+Cashell.
+
+11 Borrowing from abroad can offset the loss in American saving, but the income from that
+investment will flow to foreigners, rather than Americans.
+
+ 
+ CRS-5
+
+By contrast, the maturity at which the deficits are financed is thought to have a
+
+negligible effect on the economy and has received little attention from
+macroeconomists. Because long-term rates are thought to have a greater effect on
+investment spending than short-term rates, some macroeconomists have posited that
+if the government concentrates its borrowing at the short end of the market, it can
+flatten the yield curve by pushing down long-term rates and pushing up short-term
+rates. They argue that this would lead to more investment spending, and hence a
+higher economic growth rate, for a given budget deficit.12 This would argue against
+the reintroduction of the 30-year bond. There does not seem to be much empirical
+evidence supporting this theory, however, so if it is correct, the effect does not appear
+to be large. Furthermore, financial markets are more dynamic than their reasoning
+implies. Since investment levels are ultimately determined by national saving, which
+is not affected by changes in the yield curve, it is not clear why an increase in long-
+term borrowing by corporations would not be exactly offset by a decrease in short-
+term borrowing by corporations. If this is the case, a reintroduction of the 30-year
+bond would have no effect on private investment, and hence, economic growth.
+
+It is often argued that the economic burden of the debt comes from the interest
+
+payments that must be paid on the debt since these interest payments make taxpayers
+worse off. Economists reject this argument on the grounds that higher interest
+payments make bondholders equally better off. Therefore, the debt represents a
+transfer from one American (the taxpayer) to another (the bondholder) with no net
+effect on the economy. In this case, reintroducing the 30-year bond as a means of
+lowering interest costs (the merits of which were analyzed in the previous section)
+would redistribute income from bondholders to taxpayers but would have no effect
+on the nation’s overall welfare. This argument does not hold for the approximately
+one-half of the national debt held by foreigners, however. For this portion of the
+debt, proposals to minimize interest costs would raise U.S. welfare on net, since less
+U.S. income would be transferred to foreign bondholders.13
+
+ Effect on Financial Markets 
+
+The last of the Treasury’s three main principles guiding debt management is the
+
+promotion of efficient capital markets. U.S. Treasuries are a popular investment
+option for a wide range of individual and institutional investors, many of whom
+would be pleased to see the 30-year Treasury bond return.14 If this were their only
+significance, then one could not say they had either a positive or negative effect on
+the financial system as a whole. It is the fact that Treasuries play two special roles
+in financial markets, as a benchmark and a safe haven, that makes them of special
+
+12 Benjamin Friedman, “Debt Management Policy, Interest Rates, and Economic Activity,”
+National Bureau of Economic Research, working paper 830, Dec. 1981.
+
+13 See CRS Report RL30520, The National Debt: Who Bears Its Burden? , by Marc Labonte
+and Gail Makinen.
+
+14 In this section, the term Treasuries will be used for statements applying to Treasury
+securities of all maturities, and 30-year Treasury bond will be used for statements
+specifically applying to the 30-year bond.
+
+ 
+ CRS-6
+
+importance to the overall functioning of the financial system. The merits of
+reinstating the 30-year bond are therefore judged in terms of these two roles.
+
+ (1) Role of Treasuries as Benchmark. Treasuries play an important role
+
+in the financial system as a financial benchmark. Treasury benchmark status is
+manifested in its role in providing information about general market conditions, the
+pricing of other securities relative to Treasuries, their universal acceptance as
+collateral in a myriad range of financial transactions, and their underlying role in the
+creation of other financial instruments, such as derivatives. Treasuries are able to
+serve as a benchmark because of their predictability, liquidity, and risk-free status,
+three features that will be discussed below. 
+
+Before the late 1990s, the 30-year Treasury bond was the preferred security for
+
+benchmark status. Since 30-year bond sales dwindled with growing surpluses, and
+ultimately ended, the 10-year Treasury note has replaced it as the new benchmark.15
+While the role of the benchmark is a strong argument in favor of predictable, liquid
+Treasuries in general, it is unclear whether returning the 30-year bond to that role
+would have any advantages over maintaining the 10-year Treasury note as the
+benchmark. Perhaps the fact that, when previously given the choice, investors
+preferred the 30-year bond to the 10-year note as a benchmark is evidence that
+investors would favor its return to the benchmark role.
+
+ (2) Role of Treasuries as Safe Haven. In times of financial unrest and
+
+turmoil, large volumes of capital often flow abruptly into Treasuries. (This occurred,
+for example, in October 1998 following the Russian default.16) Some would argue
+that this has a stabilizing effect that helps to restore calm to the markets. Financial
+turmoil abroad also frequently leads to foreign capital inflows into U.S. Treasuries
+as foreigners look for a safe haven for their savings. Although the result of these
+inflows is an increase in the trade deficit, economists tend to believe that on balance
+foreign capital inflows are advantageous for the U.S. economy since they help to
+offset the negative effect of the United States’ chronically low (public and private)
+savings rate on private investment. Reinstating the 30-year bond would enhance the
+role of Treasuries as a safe haven, although the enhancement may be marginal since
+investors already have an array of Treasuries at other maturities from which to
+choose.
+
+Now that the roles played by Treasuries have been defined, it is useful to
+
+consider how the Treasury’s debt management policy supports these roles, and how
+the 30-year bond fits into this picture. To promote efficient capital markets, the
+Treasury must pursue a number of goals, including the following.17
+
+15 Gregory Zuckerman, “Ring in a New Bond Bellwether,” Wall Street Journal , May 2,
+2000, p. C1.
+
+16 Michael Fleming, “The Benchmark U.S. Treasury Market,” Economic Policy Review ,
+Federal Reserve Bank of New York, Apr. 2000, p. 132.
+
+17 Adapted from Testimony by Treasury Assistant Secretary Gary Gensler before House
+Committee on Ways and Means, June 23, 1998.
+
+ 
+ CRS-7
+
+! Neutrality . Bond issuance should have a minimal effect on the
+
+economy’s natural yield curve, accomplished by borrowing evenly
+across the yield curve.
+
+! Liquidity . The government should make Treasury markets as liquid
+
+as possible by standardizing the characteristics of the bonds issued.
+This minimizes short term volatility in bond markets following a
+large issuance or retirement of a certain type of Treasury bond. 
+
+! Predictability . Bond issuances should be announced far in advance
+
+and follow a predictable pattern. For example, three-month bills are
+auctioned every week, and the five-year note is issued four times a
+year.
+
+The rest of this section analyzes how the reintroduction of the 30-year Treasury
+
+bond would affect each of these factors. 
+
+ Effect on Neutrality. In the absence of government borrowing, the yield
+
+curve on private bonds would be determined by borrowers’ needs and lenders’
+preferences, leading to an economically efficient outcome. Maintaining this
+economically efficient outcome requires that the government borrow in a way that
+minimizes the effect on the market-determined yield curve. This suggests that the
+government should borrow evenly across the broadest range of maturities, such that
+it does not crowd private borrowers out of any portion of the market. Reintroduction
+of the 30-year bond should help the government to achieve this by increasing its role
+at the long end of the market and reducing its effect on the short and medium range
+of the market. 
+
+Furthermore, some argue that the very long end of the market is under-supplied
+
+by the private sector. There is significant demand for 30-year bonds from private
+sector participants with long-term liabilities such as banks, insurance companies, and
+pension funds. There is also significant foreign demand for long-term government
+bonds, particularly among official institutions such as foreign central banks. Yet, as
+seen in Table 1 , there is little supply of very long-term bonds from the private sector
+because most corporations prefer to borrow on a shorter-term basis. This may be
+because risk premiums become unprofitably high for corporations that far into the
+future. If the long end of the market is under-supplied, reintroduction of the 30-year
+bond can step in and fill the gap between demand and private supply. Clearly,
+investors with long-term liabilities, such as banks, insurance companies, and pension
+funds, would benefit since it would give them a lower cost method (although it is not
+the only method) for hedging against risks related to maturity mismatch.
+
+ 
+ CRS-8
+
+ Table 1. Corporate Issuance By Maturity Length 
+
+ Maturity Length 
+
+ 2000 
+
+ 2001 
+
+ 2002 
+
+30+ years 
+
+$25,496.3
+
+$61,285.2
+
+$49,906.4
+
+(total in millions)
+
+30+ years as a % of
+
+2.4%
+
+5.5%
+
+5.7%
+
+total corporate debt
+
+30+ years as a %of
+
+3.4%
+
+7.0%
+
+7.6%
+
+all corporate bonds
+
+ Source : Thomson Financial Securities Data, provided to CRS by The Bond Market Association.
+
+ Note: Total corporate debt includes bonds and commercial paper. For this table, bonds are defined
+as all corporate bonds with a maturity of one year or greater. Data in the chart do not include the debt
+of government sponsored enterprises.
+
+Some argue that this reasoning is backwards. The reason, they argue, that
+
+private borrowing is limited at the long end of the market is that previous Treasury
+borrowing crowded corporate borrowers out of the long-term market. They argue
+that 30-year corporate bonds were more widespread in the post-war period before 30-
+year Treasuries were introduced in 1977.18 After the 30-year bond was discontinued,
+a few corporations, such as Fannie Mae, Freddie Mac, and Ford did increase their
+issuance of long term bonds; however, 30-year bonds comprise only a small portion
+of their total debt. As can be seen in Table 1 , there was a big jump in issuance at the
+long end of the private market in the year the 30-year Treasury bond was
+discontinued.
+
+ Effect on Liquidity. One characteristic that makes Treasuries unique is that
+
+they are significantly more liquid than other financial instruments. That is primarily
+because government borrowing is so much larger than the borrowing of any private
+corporation. As a result, Treasuries are sold at a lower bid-ask spread than other
+instruments. All else equal, greater liquidity reduces price volatility, and this
+reinforces the role of Treasuries as a riskless asset and a benchmark. Its high degree
+of liquidity is also essential to its role as a safe haven because investors can move
+into them quickly without bearing large losses. Some economists argue that liquid
+Treasury markets enhance general financial market efficiency.19
+
+During the surplus years (FY1998-FY2001), liquidity in the overall Treasury
+
+market was maintained by focusing new issues in a narrower range of maturities and
+discontinuing new issuances in other maturities, such as the 30-year bond.
+Essentially, high liquidity was maintained at a few key maturities by sacrificing
+
+18 Benjamin Friedman, “The Treasury Threatens Corporate Balance Sheets,” Harvard
+Business Review , Sept./Oct. 1982, p. 20; Jonathan Fuerbringer, “U.S. Will End Regular Sale
+of Long Bond,” New York Times , Nov. 1, 2001, p. C1.
+
+19 For example, see Michael Woodford, “Public Debt as Private Liquidity,” American
+Economic Review, vol. 80, no. 2, 1990, pp. 382-388. 
+
+ 
+ CRS-9
+
+liquidity in maturities such as the 30-year bond. The usefulness of bringing back the
+30-year bond hinges crucially on two points. First, whether enough 30-year bonds
+would be issued to restore liquidity to the 30-year market. Second, whether this
+could be accomplished without sacrificing liquidity in Treasuries of other maturity
+lengths. Given the size of current deficits, neither should be a concern.20
+
+ Effect on Predictability. Predictability is a necessary characteristic of a
+
+benchmark and a safe haven asset. Predictability takes many forms, such as regular
+issuances, minimal price fluctuation, and maintenance of the risk-free status.
+Reintroducing 30-year Treasuries could enhance or reduce predictability, depending
+on the size of future budget deficits. Relatively small deficits could reduce
+predictability by spreading the Treasury market too thin over too many maturity
+lengths. But given the size of current deficits, the 30-year bond should increase
+predictability because the issuance of long-term debt reduces the unpredictability
+caused by rolling over debt, as discussed above.
+
+ Conclusion 
+
+The efficacy of the decision to reintroduce the 30-year Treasury bond depends
+
+first on the future direction of fiscal policy. If future budget deficits are sizable and
+long-lasting, as they are projected to be under current policy,21 then it is as sensible
+to issue 30-year bonds now as it was in the 1980s and 1990s. Alternatively, if the
+budget moves quickly back to surplus because of future policy changes or errors in
+budget projections, then there would be little purpose in reintroducing the 30-year
+bond, and the reasoning behind its discontinuation in 2001 would apply again.
+
+With that qualification, if one assumes that current budget policy will follow
+
+current projections, most analysts see few drawbacks to reintroducing the 30-year
+bond, and a number of advantages. Before reviewing the proposed advantages, it
+may be useful to note that if the Treasury had deemed them important, it presumably
+would not have discontinued the 30-year bond in 2001. 
+
+From the perspective of budgetary finance, the reintroduction of the 30-year
+
+bond might lower the government’s interest costs. This would depend on the
+government aggressively altering its borrowing patterns as interest rates change,
+however, which would be a radical departure from current debt management policy.
+Furthermore, since 30-year bond yields are typically the highest of any Treasury
+security, the occasions on which issuing 30-year bonds would lower costs would be
+relatively limited. Specifically, they would be limited to times in which interest rates
+are low and the yield curve is relatively flat or inverted. Some argue that a debt-
+management policy of aggressive cost-minimization would ultimately be self-
+
+20 It should be noted that liquidity is a relative term: even if few 30-year Treasury bonds
+were issued, making them relatively illiquid compared to other Treasury securities, they
+could still be more liquid than corporate bonds.
+
+21 See CRS Report RL31414, Baseline Budget Projections: A Discussion of Issues , by Marc
+Labonte.
+
+ 
+ CRS-10
+
+defeating since the loss in predictability and liquidity would ultimately reduce
+investor demand, raising bond yields.
+
+There is little persuasive evidence that the reintroduction of the 30-year bond
+
+could have any effect on overall interest rates, investment levels, or economic
+growth. 
+
+It is likely that the greatest benefit from reintroducing the 30-year bond would
+
+lie in its effects on financial markets (assuming future deficits are large enough that
+reintroduction of the 30-year bond would not result in less liquid markets for
+Treasuries overall). There is significant demand for 30-year bonds from private-
+sector participants with long-term liabilities such as banks, insurance companies, and
+pensions funds. There is also significant demand for 30-year bonds among
+foreigners, notably foreign central banks. Yet there is little supply of very long-term
+bonds from the private sector because most corporations prefer to borrow on a
+shorter-term basis. By reintroducing the 30-year bond, the government may step in
+and fill that gap. Before it was discontinued, the 30-year bond also played an
+underlying role in certain financial derivatives. If issued in sufficient quantity, the
+30-year bond could also fulfill the role it previously played as a financial benchmark,
+now held by the 10-year note.
\ No newline at end of file
diff --git a/corpus/politics/text/7ccbc253c37d2148.txt b/corpus/politics/text/7ccbc253c37d2148.txt
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index 0000000000000000000000000000000000000000..0b7abdef51c259ec87d1ad594c9c91fc713c9480
--- /dev/null
+++ b/corpus/politics/text/7ccbc253c37d2148.txt
@@ -0,0 +1,962 @@
+Order Code RL32384
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ EPA’s Proposed Policy on Wastewater Blending: 
+
+ Background and Issues 
+
+ Updated February 14, 2005 
+
+Claudia Copeland
+
+Specialist in Resources and Environmental Policy
+
+Resources, Science, and Industry Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ EPA’s Proposed Policy on Wastewater Blending:
+
+Background and Issues
+
+ Summary 
+
+In November 2003 the Environmental Protection Agency (EPA) proposed a
+
+policy regarding a type of wastewater treatment practice called blending. Some cities
+use blending to manage peak flows of water and waste into wastewater treatment
+plants during and after storms as a way to prevent conditions that otherwise result in
+raw sewage backups into homes and other buildings or overflows into nearby waters.
+Blending involves routing excess wastewater around the plant’s biological treatment
+processes and recombining this excess flow with fully treated wastewater before
+discharging it to a stream or lake. As of February 2005, EPA has not yet issued a
+final version of the blending policy, which is intended to clarify when the practice
+can be allowed and still adhere to Clean Water Act regulations and requirements.
+
+Although blending has been standard engineering practice for several decades
+
+as a way to manage peak stormwater flows, controversy exists about the practice,
+both among stakeholder groups and also internally at EPA, where enforcement
+officials have challenged the practice and in some cases opposed allowing cities to
+use it. Others at EPA believe that, with certain restrictions, the practice is legal and
+environmentally protective.
+
+This report provides background on blending, why and how it is practiced,
+
+EPA’s proposed policy, associated issues, and congressional interest in the topic. It
+will be updated as warranted.
+
+Criticism of blending focuses on three concerns: legality of the practice, impacts
+
+on public health and the environment, and other policy issues. A number of groups
+and interests have weighed in on all of these issues, especially in comments on the
+November 2003 proposed policy. Environmental advocates say that the practice of
+blending is inconsistent with existing rules that prohibit intentional bypass of a
+treatment facility. These groups have also raised substantial concern about public
+health and environmental impacts from discharges of wastes that contain pathogenic
+organisms. Many cities and municipal organizations support the EPA policy and
+practice of blending, saying that if cities are barred from blending, they are forced to
+make costly infrastructure investments, with limited benefit. While a number of
+states support the EPA policy, others oppose it for reasons including concern that the
+policy would undermine incentives for cities to remedy the infrastructure problems
+that result in sewage overflows.
+
+In Congress, these issues have drawn some attention. In January 2004,
+
+Members with differing views wrote to EPA to express concerns about the proposed
+EPA policy. Congress has several options at this point, ranging from allowing EPA
+to handle the issue administratively, to conducting oversight of issues raised by the
+proposed policy, or to legislating in order to direct EPA’s actions, by expressly
+permitting, prohibiting, or modifying the policy. Legislation intended to bar EPA
+from issuing blending rules or guidance was introduced in the 108th Congress (H.R.
+5421), but no action occurred on the bill.
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Wastewater Treatment Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+Federal Law and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Wet Weather Pollution Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Administrative Actions: CSO and SSO Policies . . . . . . . . . . . . . . . . . . . . . . 5
+What is Blending? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
+EPA’s Blending Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+Issues with Respect to Blending . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+
+Legality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+Public Health and Environmental Impacts . . . . . . . . . . . . . . . . . . . . . . . . . . 11
+
+Water Quality Criteria for Bacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
+
+Other Policy Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
+
+Congressional Interest and Status of the Proposal . . . . . . . . . . . . . . . . . . . . . . . . 15
+
+ List of Figures 
+
+Figure 1. Blending at a Sewage Treatment Facility During a Storm . . . . . . . . . . 7
+
+ 
+ EPA’s Proposed Policy on Wastewater
+
+Blending: Background and Issues
+
+ Introduction 
+
+The Environmental Protection Agency (EPA) is considering issuing a policy
+
+regarding a wastewater treatment practice called blending. It is a type of wastewater
+management practice that is used to prevent conditions that result in sewage backups
+into homes and other buildings, or overflows of untreated waste into nearby waters.
+Blending has been used for several decades to manage peak flows of water and waste
+into wastewater treatment plants during storms, but it recently has become
+controversial. The practice involves routing excess wastewater from domestic,
+commercial and industrial sources around the plant’s biological treatment processes
+and recombining this excess flow with fully treated wastewater before discharging
+it to a stream or lake (see Figure 1, on page 7). In November 2003 EPA proposed a
+policy to clarify when the practice can be allowed and still adhere to Clean Water Act
+regulations and requirements. As of February 2005, a final policy has not yet been
+issued, although it has been expected for some time.
+
+This report provides background on blending, why and how it is practiced,
+
+EPA’s proposed policy, associated issues, and congressional interest in the topic.
+Controversy exists about whether the practice is lawful under water quality
+regulations, whether it is harmful to human health or the environment, and whether
+it is good from a policy perspective. Supporters of the proposed policy, including
+many cities, municipal organizations and some states, say that if blending is restricted
+or prohibited, cities will be forced to spend limited public resources on costly water
+infrastructure improvements that are used infrequently. Such critics as environmental
+advocates and other states say that blending allows treatment plants to discharge
+wastewater that could contain harmful pathogenic microorganisms. Many critics also
+say that EPA’s proposed policy would allow treatment plants to blend even when
+other more environmentally protective technological options are available. A key
+issue is whether the final policy, when and if issued, would clarify EPA regulations
+to allow the safe use of blending by cities, as EPA intends, or would foster wider use
+of wastewater management practices that critics believe will harm public health and
+the environment.
+
+ The particular issues concerning blending also arise in the broader context of
+
+policymakers’ efforts to control pollution associated with wet weather discharges that
+happen only during and after major precipitation events. EPA believes that these
+sources, including combined sewer overflow discharges, stormwater, separate
+sanitary sewer overflows, and nonpoint source runoff, are the leading cause of water
+
+ 
+ CRS-2
+
+quality impairment in the United States.1 The nation’s initial efforts to control water
+pollution focused on conventional point sources from municipal, commercial, and
+industrial wastewater treatment plants that are typically characterized by predictable
+flows and identifiable discharge points. Since the mid-1980s, policymakers have
+turned attention to other, non-traditional wet weather pollution sources that are more
+difficult to control because the sources are numerous and geographically dispersed,
+and waste flows are intermittent and largely unpredictable. Managing these diverse
+sources presents major policy and technological challenges.
+
+ Background 
+
+ Wastewater Treatment Processes 
+
+In the United States, wastewater is discharged from sources such as homes or
+
+industrial plants and is transported via collection systems consisting of sewers and
+pumping facilities to a wastewater treatment facility. The wastewater components
+of major concern are organic and inorganic materials that will deplete the oxygen
+resources of the stream or lake to which they are discharged, those which may
+stimulate undesirable growth of plants or organics (such as algae) in the receiving
+water, or those with potential undesirable aesthetic effects or adverse health effects
+on downstream water uses. Another important wastewater treatment concern is
+removal of pathogenic bacteria and viruses that can cause disease.
+
+Treatment plants generally work in two stages. Primary treatment mechanically
+
+separates the coarser solids from the water, generally by screening and settling,
+typically removing about 60% of solids and 35% of BOD from the untreated waste.2
+The core element of wastewater treatment, called secondary treatment, follows
+primary treatment; it typically involves biological processes. The biologic process
+most often used today is the activated sludge process, which utilizes microorganisms
+in an aerobic environment to remove a majority of the primary pollutants found in
+wastewater. The microorganisms (bacteria and protozoa) use the remaining nutrients
+and organic material in the wastewater as their food supply. Although secondary
+treatment may remove more than 85% of the remaining BOD and suspended solids,
+it fails to remove significant amounts of nitrogen, phosphorus, or heavy metals, nor
+does it completely remove pathogenic bacteria and viruses. If further treatment such
+as nutrient removal is required to meet water quality standards, tertiary biologic or
+chemical treatment processes can be used. Following secondary or tertiary treatment,
+
+1 U.S. Environmental Protection Agency. National Water Quality Inventory, 2000 Report .
+EPA-841-R-02-001. August 2002. P. ES-3.
+
+2 BOD, or biochemical oxygen demand, is a measure of the oxygen-consuming organic
+matter and ammonia-nitrogen in wastewater and is used to determine how well a treatment
+plant is working. The higher the BOD loading, the greater the resulting depletion of oxygen
+in the waterway. The ability of a body of water to support life depends mainly on
+maintaining a certain amount of dissolved oxygen (DO) because, for example, DO is what
+fish breathe. Thus, federal regulations (and facility-specific permits that implement those
+rules) specify maximum amounts of BOD that wastewater treatment plants may discharge,
+as measured by the oxygen consumed in a stated period of time, usually five days (BOD ).
+
+5
+
+ 
+ CRS-3
+
+the final effluent generally is disinfected before it is released to a receiving water,
+most commonly by chlorination, ultraviolet irradiation, or ozonation.
+
+ Federal Law and Regulations 
+
+The 1972 Federal Water Pollution Control Act Amendments (P.L. 92-500,
+
+commonly referred to as the Clean Water Act, or CWA) established a framework for
+upgrading the nation’s wastewater infrastructure as one key element in the act’s
+wide-ranging objective to restore the quality of the nation’s waters. The CWA
+established a minimum pollution control standard for municipal wastewater
+infrastructure, applicable nationwide, based on the application of secondary
+treatment. It mandated application of more stringent treatment standards and
+pollution control technology where necessary to protect local water quality and
+established a permit program to ensure implementation of standards. 
+
+These requirements are implemented through regulations promulgated by the
+
+EPA that define minimum levels of effluent quality for publicly owned treatment
+works (POTWs) prior to discharge. The requirements of the secondary treatment
+regulations are expressed as concentration limitations (seven-day and 30-day average
+effluent concentration limits for total suspended solids (SS) and BOD ), percentage
+
+5
+
+removal requirements for both SS and BOD , as well as a limitation on pH. For most
+
+5
+
+types of POTWs, the federal regulations establish a 30-day average percentage
+removal requirement of 85% for SS and BOD . The percent removal requirements
+
+5
+
+were established to achieve two basic objectives, according to EPA: (1) to encourage
+cities to correct excessive infiltration and inflow I/I problems in their sanitary sewer
+systems,3 and (2) to help prevent intentional dilution of influent wastewater as a
+means of meeting permit limits.4
+
+EPA regulations also define standard permit conditions to be included in all
+
+Clean Water Act discharge permits. One of those standard conditions addresses
+“bypasses,” which are defined as “the intentional diversion of waste streams from any
+portion of a treatment facility” (40 CFR §122.41(m)). Under these rules, a bypass
+is prohibited unless: it is unavoidable to prevent loss of life, injury, or severe property
+damage; there are no feasible alternatives, such as use of auxiliary treatment or
+backup facilities or retention of untreated wastes; and proper notice is provided to the
+appropriate permitting authority. The bypass cannot cause effluent limitations to be
+exceeded.
+
+3 Infiltration occurs from too much rainfall or snowmelt percolating through the ground into
+leaky sewers which are not intended to collect rainfall or to drain property. Infiltration can
+also occur as a result of groundwater seeping directly into leaky sewers. Excess water can
+also inflow through roof drains connected to sewers and broken or badly connected sewer
+service lines.
+
+4 68 Federal Register 216, Nov. 7, 2003, p. 63047.
+
+ 
+ CRS-4
+
+ Wet Weather Pollution Problems 
+
+The collection system that conveys wastewater to the treatment plant is a key
+
+element of the overall wastewater infrastructure system. Collection systems are
+either combined sewer systems, which are designed to carry domestic and industrial
+sanitary waste plus rainwater; or separate sanitary sewer systems, designed to collect
+only domestic and industrial sanitary waste.5 Treatment plants and collection
+systems are designed to handle the flows up to certain volumes under routine or
+predictable operating conditions. A more difficult challenge is that of managing
+flows that occur under peak flow conditions, during what is referred to as “wet
+weather” events (rainfall, as well as snowmelt). 
+
+Extreme wet weather events can introduce larger volumes of water and waste
+
+than the plant and collection system can adequately manage, resulting in collection
+system overflows and backups of sewage into buildings, and water quality problems
+from discharges of inadequately treated waste. During storm events, both combined
+and separate sewer systems can experience overflows when the capacity of a sewer
+is exceeded as a result of blockages, bottlenecks and/or undersized pipes. The
+discharge of untreated or partially treated sewage contains pathogenic organisms that
+represent a health risk and also may contain toxic and/or oxygen-demanding
+pollutants. Infiltration/inflow of rainwater into sewers is believed to be the primary
+factor causing peak flows in sewers, especially separate sanitary sewers. Aging
+infrastructure and associated maintenance challenges can also lead to excess water
+in sanitary sewer systems. High levels of I/I that reach the treatment plant increase
+the hydraulic load on the plant, which can reduce treatment efficiency, exceed the
+capacity of components within the plant, and in extreme situations make biological
+treatment facilities inoperable. Treatment plant operators use a combination of
+strategies to manage these peak flows, including implementing operation and
+maintenance programs, enlarging pipes, adding or increasing storage capacity,
+building additional treatment facilities, or using alternative treatment techniques to
+move peak flows through the treatment.
+
+Operators of treatment plants and collection systems have long faced these
+
+challenges, and for the last 15 years or so, policymakers have been addressing various
+wet weather pollution issues, including developing strategies to reduce overflows and
+backups, as well as establishing appropriate regulatory and enforcement policies. 
+
+By definition, sewer overflows are unauthorized discharge points that violate the
+
+Clean Water Act’s prohibition on discharges that are not in compliance with the
+limitations and conditions of a discharge permit issued pursuant to the CWA.
+Nevertheless, municipal officials and sanitary engineers say that it is practically
+impossible to design a system that will never overflow. Even under the best of
+conditions, engineers say, natural disasters and even pipe failures will lead to
+
+5 Combined sewer systems are remnants of the nation’s early infrastructure and are found
+in about 900 communities, primarily in older cities in the Northeast, Great Lakes region, and
+the Pacific Northwest. Most combined sewer systems were constructed before 1900 when
+the necessity for separate wastewater treatment was not readily apparent.
+
+ 
+ CRS-5
+
+unavoidable releases of sewage. However, chronic overflows result from inadequate
+system maintenance and deterioration, not unavoidable circumstances. 
+
+Recognizing the view that sewer overflows are, at least to a degree, unavoidable,
+
+some permitting authorities have issued Clean Water Act permits to POTWs
+allowing overflow discharges — despite the statutory prohibition on discharges that
+do not meet secondary treatment requirements. For example, some permits authorize
+overflows when they are not feasible to avoid, such as circumstances beyond the
+control of the system operator. In rare cases, other permits may allow discharges at
+specified locations, when specific permit requirements are met, such as meeting
+effluent limitations, monitoring, and reporting. However, in other cases, state and
+federal enforcement officials have held to the view that overflow discharges are
+inconsistent with the Clean Water Act and have brought actions against
+municipalities for overflows from combined and separate sewers, thus raising
+questions about the clarity of EPA regulations and consistency of enforcement.
+
+ Administrative Actions: CSO and SSO Policies 
+
+In part because of perceptions of inconsistent policy and rules, in 1994, after
+
+lengthy consultations with stakeholder groups, EPA issued a national strategy on
+controlling overflows from combined sewers (CSOs). Designed to reduce CSO
+discharges that often contain high levels of organic and toxic wastes, it outlined
+conditions under which combined sewer systems that overflow as a result of wet
+weather events may be authorized through permits or other enforceable mechanisms,
+including a requirement that systems adopt nine minimum controls and long-term
+control plans. 
+
+Soon after issuance of the CSO policy, EPA and a group of stakeholders
+
+initiated discussions for development of similar national policy on controlling
+overflows from separate sanitary sewers (SSOs). The discussions about an SSO
+policy were based on certain principles: clarifying a general prohibition on overflows;
+establishing stringent but feasible standards and requiring specific actions that would
+help eliminate avoidable overflows; and defining circumstances for enforcement
+against unavoidable overflows.6 EPA officials and stakeholders were unable to reach
+consensus on SSO policy issues, and eventually EPA decided to move ahead with
+regulations to control SSO discharges. The Clinton Administration approved an SSO
+rule proposal late in 2000. The proposal was not published in the Federal Register
+ before Inauguration Day in January 2001, and the incoming Bush Administration
+suspended it for review. However, it was widely circulated and was available to the
+public for some time on EPA’s website.
+
+6 Combined sewer systems are, in fact, designed to discharge excess wastewater directly into
+surface waters, when the capacity of the sewer system is exceeded during heavy rainfall or
+snowmelt. In regulating CSOs, the key concern is first to eliminate overflows during dry
+weather conditions and then to minimize impacts of storm-related discharges. The issues
+involving SSOs are somewhat different, because separate sanitary sewers are not designed
+to overflow. When storm sewer overflows occur, they usually are from undesigned outfall
+points. Prohibiting and eliminating all overflows to the extent feasible is key.
+
+ 
+ CRS-6
+
+After several months of review, in November 2001 EPA officials announced the
+
+intention to propose the SSO rule developed by the Clinton Administration, but with
+revised preamble language. During the review EPA considered a number of options,
+including separate publication of noncontroversial parts of the Clinton proposal.
+Chief among the controversies raised was whether EPA would open discussion of
+alternatives to prohibiting SSOs or would retain the policy detailed in the Clinton
+rule calling for strict enforcement against any overflows, regardless of fault. It
+appears that these and other controversies persist, because as of May 2004, EPA has
+not proposed or published an SSO control regulation. 
+
+During the SSO rule review, EPA staff also began working on draft guidance
+
+on other wet weather peak flow management issues that was envisioned as separate
+from but related to the SSO rule. In December 2001, EPA circulated among
+stakeholders a draft guidance document addressing permit requirements and
+enforcement procedures applicable under existing rules to three specific wet weather
+situations. One of the three addressed the use of alternative peak flow treatment
+schemes at the POTW (in contrast, for example, to procedures governing discharges
+from emergency overflow structures located outside the boundary of a treatment
+plant) — a practice generally referred to as “blending.” The December 2001 draft
+was never formally proposed or finalized (although it was circulated to states, EPA
+regional offices, and multiple other stakeholders). It evolved into a single proposal
+published by EPA in November 2003 that focuses only on blending.7
+
+ What is Blending? 
+
+Blending is a wastewater flow management technique used by some treatment
+
+plants during and after storm events. In order to manage high flows in the collection
+system at such times, a POTW operator modifies the flow of wastewater through the
+treatment plant. During blending, primary treatment is provided for all flows coming
+into the facility, and secondary treatment is provided for flows up to the capacity of
+the secondary biological treatment units. The latter typically are designed with less
+capacity than primary treatment units, which can handle significant variations in flow
+and concentration of pollutants, while the microorganisms in biological units are
+more sensitive and can be negatively affected by such changes. The excess flows are
+diverted around the secondary biological treatment units and then recombined, or
+blended, with flows that have been treated by the secondary units. The blended
+effluent is usually disinfected prior to discharge to a lake, stream, or coastal
+waterbody — particularly if the discharge will affect bathing or fishing waters.
+Figure 1 illustrates the process.8
+
+Sanitary engineers and municipal officials say that blending is necessary because
+
+if surges of excess flow from storm events enter the secondary treatment units, they
+
+7 U.S. Environmental Protection Agency. “National Pollutant Discharge Elimination System
+(NPDES) Permit Requirements for Municipal Wastewater Treatment Discharges During
+Wet Weather Conditions.” 68 Federal Register 216, Nov. 7, 2003, pp. 63042-63052.
+
+8 A typical sewage treatment system schematic showing flows during non-storm conditions
+would look the same as Figure 1 but would not show part of the flow being diverted around
+secondary treatment units.
+
+ 
+ 
+
+CRS-7
+
+will wash out the bacteria which comprise the biological processes used during
+secondary treatment. These bacteria are less tolerant of variations in flow volumes
+and strength (i.e., more rainwater and more dilute/less sewage) than are systems used
+in primary treatment units. If the bacteria are washed out, it can take weeks or
+months for a biological treatment unit to recover by re-generating the necessary
+microorganisms; in the mean time, excess pollutants may be discharged to the
+environment. POTW officials say that it is not possible to build treatment plants to
+a capacity where they could treat 100% of all wastewater during peak flows, because
+during the more common dry periods, the biological component of the treatment
+process would essentially starve to death.
+
+ Figure 1. Blending at a Sewage Treatment Facility During a Storm 
+
+ Source: CRS.
+
+As noted above, POTWs have a number of technological options for managing
+
+peak wet weather flows beyond the boundary of the facility, ranging from correcting
+infiltration and inflow in order to reduce the hydraulic load in the sewer system, to
+constructing equalizing basins or storage tanks to hold rainwater off-line until flows
+can be routed to the treatment plant. Milwaukee and Chicago, for example, have
+built elaborate underground tunnel systems to temporarily hold peak flows. Some
+cities also are investigating or constructing new or innovative technologies. One of
+these is a high-rate clarification process with rapid settling of solids from the waste,
+which both provides some initial treatment and reduces the volume of waste material.
+Other technological options involve constructing secondary-equivalent treatment
+units based on physical/chemical, not biological, processes, which can be started up
+quickly and can sit idle between storm events. Depending on land availability, some
+of these technologies may be used on-site at the POTW. Others are utilized remotely
+
+ 
+ CRS-8
+
+and can provide sufficient treatment to comply with EPA’s secondary treatment
+discharge limits for suspended solids and BOD .9
+
+5
+
+Treatment plant operators view blending as another technological option, one
+
+that is preferable to overflow discharges of untreated waste or sewage backups in
+basements. In 2002, the Association of Metropolitan Sewerage Agencies,
+representing many of the nation’s large POTWs, conducted a survey on wet weather
+management. Thirty percent (78) of AMSA’s members responded, and 37
+respondents (47%) said they do blend during wet weather conditions, generally only
+a few times per year. Of 41 who do not currently blend, 24 (58%) said that blending
+would enable the POTW to meet permit limits all or a majority of the time.10
+Proponents of blending argue that, if blending is restricted, municipalities are forced
+to spend public resources to build structures with limited public benefit, because of
+their infrequent use during occasional storm events. While EPA has not estimated
+the national cost of providing sufficient treatment to preclude blending, it has
+estimated that the cost of correcting sanitary sewer overflow occurrences nationwide
+— a rough surrogate — is $88.5 billion.11 Groups representing municipalities believe
+that the cost is likely to be higher, perhaps from $200 to $300 billion.
+
+ EPA’s Blending Policy 
+
+Blending has been standard engineering practice since the 1970s, engineers say,
+
+as a way to manage peak flows during storm events to prevent conditions that result
+in backups into homes and other buildings or overflows of untreated waste into
+nearby waters. Nevertheless, controversy exists about the practice, both among
+stakeholder groups and also between several of EPA’s regional offices and some staff
+at EPA Headquarters offices. EPA’s Office of Water has generally supported the
+practice, but the Office of Enforcement and Compliance Assistance (OECA) has
+challenged it. Officials in OECA have argued that, without certain restrictions, the
+practice of blending is not enforceable. With appropriate restrictions, they say,
+permits authorizing blending are possible, but crafting permits to do so is complex
+and confusing. Others in EPA believe it is possible to write permits that lawfully
+allow for blending, and the policy that EPA proposed in November 2003 was
+intended to clarify how existing Clean Water Act regulations and permit
+requirements apply to wet weather blending scenarios. 
+
+9 It is more problematic for these alternative technologies to achieve the percentage removal
+requirement of EPA’s secondary treatment rules, because wastes are more diluted in higher
+volume wet weather flows than in normal dry weather flows.
+
+10 Association of Metropolitan Sewerage Agencies. “AMSA Wet Weather Survey, Final
+Report.” May 2003. 37 p. Available at [http://www.amsa-cleanwater.org/advocacy/
+wwsurvey/WetWeatherFinalReport.pdf]
+
+11 U.S. Environmental Protection Agency. Clean Watersheds Needs Survey 2000, Report
+to Congress . EPA-832-R-03-001, August 2003, pp. 4-1 - 4-3.
+
+ 
+ CRS-9
+
+The proposed policy sets forth six criteria for managing peak flows, including
+
+blended discharges:
+
+! The final blended discharge must meet effluent limitations based on
+
+the secondary treatment regulation, including applicable percentage
+removal requirements, or any more stringent limits necessary to
+attain water quality standards.
+
+! The facility’s permit application must specify the treatment scenario
+
+that would be used for peak flow management.
+
+! All flow must receive at least the equivalent of primary clarification.
+! Peak flow treatment should be operated as designed and only be
+
+used when flows exceed the capacity of storage units and biological
+treatment units.
+
+! The facility’s discharge permit must require sufficient monitoring to
+
+ensure compliance with applicable Clean Water Act requirements.
+
+! The permit also must require that the permittee’s collection system
+
+be properly operated and maintained.
+
+In addition, the policy states that, where physically possible and economically
+achievable, blended effluent should not be discharged to sensitive receiving waters,
+such as beaches, public drinking water intakes, waters with threatened or endangered
+species, or designated Outstanding National Resource Waters and National Marine
+Sanctuaries. EPA’s proposed policy assumes that if blending is done under the
+limited terms of the policy, the practice is fully protective of human health and the
+environment.
+
+ Issues with Respect to Blending 
+
+Criticism of blending encompasses three areas: legality of the practice, impacts
+
+on public health and the environment, and other policy concerns. 
+
+As discussed below, a number of groups and interests have weighed in on these
+
+issues, especially in comments on the November 2003 proposed policy.
+Environmental advocates oppose the practice on legal grounds, and they and public
+health professionals have raised substantial concern based on public health and
+environmental issues. Proponents include many cities and municipal and local
+government organizations, including the National League of Cities, National
+Association of Counties, and Association of Metropolitan Sewerage Agencies
+(AMSA). Among states, views differ. Several states support EPA’s proposed policy,
+others support it with additional restrictions or clarification (such as barring blended
+discharges into impaired waters where water quality standards have not yet been
+attained), and others oppose the practice based on a variety of policy concerns. In
+some instances, individual cities commented in support of the policy, but agencies
+of these cites’ home states opposed it (for example, the Miami-Dade Water and
+Sewer Department supported it, while the Water Resources Management Division
+of Florida’s Department of Environmental Protection opposed it).
+
+ 
+ CRS-10
+
+ Legality 
+
+The focus of legal concerns over blending rests on whether the practice is
+
+inconsistent with EPA’s existing “bypass” regulation which prohibits “intentional
+diversion of waste streams from any portion of a treatment facility” and requires a
+determination that “no feasible alternatives” to the bypass exist, including installation
+of adequate backup facilities (40 CFR §122.41(m)). Critics argue that these
+provisions preclude blending and mandate that POTWs provide larger plant
+capacities, including temporary storage, so that all influent flows enter every
+treatment process unit. Since secondary treatment units are clearly part of the
+treatment unit, according to this view, blending violates the bypass rule’s prohibition
+of intentional diversion. A bypass is allowed under EPA regulations when it is
+unavoidable, but critics say that the proposed blending policy would allow it as more
+routine practice. In the November 2003 proposed policy and guidance, EPA
+interprets the bypass rule to allow for blending that complies with the criteria spelled
+out in the policy. Proponents of blending argue that, as long as the system is operated
+as designed, and the planned operational regime is disclosed to the permitting
+authority, it fully complies with the bypass regulation.
+
+Concern over the legality of blending is the basis of actions brought by EPA
+
+enforcement officials in several regions — especially Region III (Philadelphia),
+Region IV (Atlanta) and Region VI (Kansas City) — challenging Clean Water Act
+permits proposed by state permitting authorities that would allow for blending.12
+These EPA regions, supported by states and environmental advocates, have declined
+to authorize blending in discharge permits because they believe the practice violates
+Clean Water Act rules mandating that all wastewater meet secondary treatment
+standards. Some other EPA regions have not prohibited or limited blending in
+POTW permits and have generally agreed with supporters of the practice that permits
+could, under certain circumstances, authorize re-routing or recombination of waste
+without being considered a bypass. For example, supporters say, if analysis of
+feasible alternatives has been done and permitting authorities have been notified,
+blending does not constitute a bypass. In 2002, a group of cities from Pennsylvania,
+Tennessee, and Arkansas and AMSA brought legal action against EPA, alleging that
+the prohibition on blending exercised by some EPA regions is not evenly applied
+among its regional offices and is not supported by any national regulation. The
+lawsuit was dismissed by a federal district court in November 2003, the court saying
+that it lacked subject matter jurisdiction over regional guidance documents that do
+not constitute final agency action by EPA Headquarters ( Pennsylvania Municipal
+Authorities Association v. Horinko , D.D.C., No. Civ. 02-01361, Nov. 20, 2003).
+
+Some EPA enforcement officials reportedly are concerned that issuance of a
+
+national policy would allow POTW operators to reopen consent decrees that now
+prohibit blending among other wet weather management controls. Alternatively,
+
+12 The Clean Water Act allows EPA to delegate permitting responsibility to qualified states,
+and EPA has done so for 45 states and one territory. EPA issues permits in the remaining
+states and territories. However, even after delegation, EPA retains oversight to ensure that
+state-issued permits comply with the CWA’s requirements. If EPA objects in writing to a
+permit, the permit may not be issued (§402(d)(2)).
+
+ 
+ CRS-11
+
+some are said to be concerned that POTWs could potentially sue EPA under the
+Federal Tort Claims Act to receive compensation for having installed costly pollution
+controls or that they might petition EPA and states to revise their discharge permits.
+
+ Public Health and Environmental Impacts 
+
+The largest area of disagreement about blending rests on the issue of public
+
+health and environmental impacts. Supporters of the practice contend that, so long
+as the ultimate discharge from a POTW complies with EPA’s secondary treatment
+rule or more stringent local water quality limits — as the proposed policy would
+require — public health and the environment are adequately protected.
+
+Disease-causing pathogens, including bacteria, parasites and viruses, can be
+
+found in domestic sewage, and may cause both chronic and acute illnesses, ranging
+from cholera, gastroenteritis, infectious hepatitis, and shigellosis to respiratory and
+skin infections. Outbreaks of waterborne diseases are associated both with exposures
+to contaminated drinking water supplies (resulting from such causes as inadequate
+treatment, disrupted treatment processes, or cross-contamination of wastewater and
+water supplies lines) and exposure to contaminated recreational waters. According
+to surveillance data compiled by EPA and the Centers for Disease Control and
+Prevention (CDC), states report, on average, approximately 20 such outbreaks per
+year linked to drinking water supplies and 30 per year linked to recreational water
+exposure, in total causing illness in several thousand persons annually. Since 1989,
+the number of gastroenteritis-related outbreaks involving recreational waters has been
+gradually increasing.13 The concern of public health and environmental advocates
+about blending and other peak flow management issues is whether effluent
+containing pathogens is being adequately treated prior to discharge. 
+
+EPA’s secondary treatment rules do not specifically limit pathogens. While
+
+primary wastewater treatment processes may remove about one-half of the suspended
+solids and BOD from raw wastewater, these processes are not effective in removing
+microbial pollutants. Secondary treatment removes about 85% of the organic matter
+in sewage and is considerably more effective at removing microorganisms —
+including up to 99% of viruses, which are known to cause a significant percentage
+of all gastrointestinal illnesses, and 99% of bacteria and parasites.14 Two Canadian
+studies reported that primary wastewater treatment removes on average 76% and
+27%, respectively, of Cryptosporidium and Giardia lambia , parasites associated with
+waterborne illness in the United States, and that secondary treatment was needed to
+achieve 90% or greater reduction of both.15
+
+13 Lee, Sherline H., Deborah A. Levy, Gunther F. Craun, Michael J. Beech, Rebecca L.
+Calderon. “Surveillance of Waterborne-Disease Outbreaks — United States, 1999-2000.”:
+Nov. 22, 2002/(appears in Morbidity and Mortality Weekly Report) 51 (SS08);1-28.; online
+at [http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5108a1.htm].
+
+14 U.S. Environmental Protection Agency. Office of Research and Development. Design
+Manual: Municipal Wastewater Disinfection. EPA/625/1-86-021, 1986, Table 2-3, p. 6.
+
+15 Katonak, Rachel and Joan B. Rose. “Public Health Risks Associated with Wastewater
+Blending.” Department of Fisheries and Wildlife, Michigan State University, Final report,
+
+(continued...)
+
+ 
+ CRS-12
+
+When primary treatment alone is provided, very high doses of chlorine are
+
+required to remove viruses or parasites. Moreover, when extra doses of chlorine are
+needed to disinfect the primary-treated waste, the chlorine combines with certain
+organic matter in the wastewater, creating compounds such as trihalomethanes,
+which are hazardous chemicals. These disinfection by-products are carcinogenic and
+may increase risk of cancer to humans, thus creating a secondary set of health
+hazards.
+
+Supporters of blending respond to the arguments about public health impacts by
+
+acknowledging that primary treatment alone does not remove all pathogens, but also
+by pointing to the paucity of data to actually link human health impacts to discharges
+of raw or partially treated sewage. For example, to understand the relative magnitude
+of major sources to water contamination, a project by the Water Environment
+Research Federation studied occurrence of the parasite Cryptosporidium in two
+Wisconsin watersheds and found that contributions of Crypto oocysts from POTW
+effluents were nearly insignificant compared with contributions from other sources,
+especially wastes in uncontrolled runoff from farm lands and urban/suburban lands.16
+
+While supporters and critics disagree on a number of issues, they are in broad
+
+agreement on one point: more monitoring and investigation are needed to determine
+the frequency of sewer overflows and assess the number of people made ill from
+waterborne diseases related to such discharges. Data on the incidence of waterborne
+diseases in the United States (and other impacts, such as closing of beaches and
+shellfish beds) frequently are unable to pinpoint the source or sources of
+contaminating agents. Both environmental advocates and groups representing
+POTW operators want more study of the possible health problems — the latter saying
+that, if there are only limited scientific studies documenting a problem, it is unwise
+for the nation to spend scarce public resources to address it. Environmental
+advocates say that the lack of data linking wastewater discharges to waterborne
+illnesses does not mean that the connection does not exist — the problem is in
+quantifying the health risk. 
+
+These questions were partly addressed in an August 2004 EPA report to
+
+Congress that was mandated by the Wet Weather Water Quality Act of 2000 (P.L.
+106-554) concerning human health and environmental impacts of CSOs and SSOs.
+In that report, EPA said that there is an absence of direct cause-and-effect data
+relating the occurrence of CSO and SSO discharges to specific human health impacts,
+due to factors such as under-reporting of waterborne illness and the presence of
+pollutants from other sources. But, based on data from a subset of the nation’s
+swimming areas, EPA estimated that between 3,448 and 5,576 illnesses occur
+annually in people exposed to waters contaminated with bacteria and viruses from
+sewer overflows. That estimate, the report said, captures only a portion of the likely
+number of annual illnesses attributable to CSO and SSO contamination of
+
+15 (...continued)
+Nov. 17, 2003, pp. 22-23.
+
+16 Water Environment Research Foundation. Sources and Variability of Cryptosporidium
+in the Milwaukee River Watershed . Stock no. 99HHE2. 2003. 132 p.
+
+ 
+ CRS-13
+
+recreational waters.17 Uncertainty about public health impacts continues to affect
+finalization of EPA’s proposed policy, as critics contend that the bypass of secondary
+treatment in a blending scenario may not adequately protect human health and that
+current monitoring strategies do not accurately assess the amount of harmful bacteria
+present in surface water after blending.
+
+ Water Quality Criteria for Bacteria. In the Federal Register Notice
+
+announcing the proposed blending policy, EPA said that it encourages states to adopt
+protective water quality criteria for bacteria in their water quality standards, since
+standards based on scientifically sound methods are needed as indicators for
+determining the human health risk from pathogenic microorganisms in waste
+discharges.18 The likelihood of states doing so voluntarily is uncertain, however. 
+
+EPA publishes water quality criteria which consist of scientific information on
+
+the concentrations of specific constituents in water which protect aquatic life or
+human health. The issue concerning water quality criteria for bacteria stems from the
+fact that, in the early years following enactment of the 1972 Clean Water Act, EPA’s
+recommended water quality criteria were based on specific levels of fecal coliform
+to be used as the indicator organism to protect bathers from gastrointestinal illness
+in recreational waters, and consequently most state-adopted water quality standards
+have been based on that indicator since the 1970s. In 1986, EPA recommended that
+states adopt criteria based on Escherichia coli ( E. coli ) and enterococci to
+demonstrate the presence of fecal pollution, because newer epidemiological studies
+have found a stronger correlation between swimming-associated gastroenteritis and
+these organisms than with fecal coliform or other indicator organisms.
+
+In the Beaches Environmental Assessment and Coastal Health Act of 2000
+
+(BEACH Act, P.L. 106-284), Congress required the 30 coastal and Great Lakes states
+to adopt EPA’s 1986 water quality criteria for pathogens by April 2004. As required
+by that law, in July 2004 EPA proposed federal water quality criteria for 20 states
+that missed the deadline for adopting more up-to-date criteria for pathogens in their
+water quality standards. At that time, EPA said that 16 states were in the process of
+adopting revised criteria, while four states had not moved forward on the criteria.
+Most of the 20 states have standards in place, but EPA does not think they are
+adequately protective of human health because they rely on fecal coliforms as the
+pathogen indicator, rather than incorporating limits for E. coli . However,
+wastewater treatment officials and some in the scientific community have questioned
+use of the 1986 criteria document because it relies on data that are more than 20 years
+old. EPA acknowledges that problem and is working on additional epidemiological
+studies of pathogen indicators of illnesses at beaches in order to develop new water
+quality criteria to protect swimmers in recreational waters by October 2005, as
+mandated by the BEACH Act. In the mean time, the law requires EPA to press states
+to adopt standards based on the existing criteria for pathogens.
+
+17 U.S. Environmental Protection Agency. Office of Water. Report to Congress, Impacts
+and Control of CSOs and SSOs. EPA 833-R-04-001. August 2004. p. 6-9.
+
+18 68 Federal Register 216, Nov. 7, 2003, p. 63051.
+
+ 
+ CRS-14
+
+ Other Policy Concerns 
+
+Critics of EPA’s November 2003 proposed policy, including environmental
+
+advocates and a number of states, believe that the proposal would not definitively
+restrict blending to wet weather events only. Some state officials, for example, say
+that allowing blending undermines the POTW’s incentive for removing wet weather
+infiltration and inflow and otherwise improving the collection system.19 These and
+other critics assert that the policy would allow bypasses to become routine and would
+relieve treatment plant operators from analysis to determine if there are feasible
+alternatives to bypass/blending. According to these critics, blending succeeds in
+meeting permit discharge limits by virtue of dilution (mixing), not technological
+pollution control. Further, blending in effect shifts the cost of treating wet weather
+flows to drinking water suppliers, who become responsible for removing residual
+microorganisms or harmful disinfection byproducts that enter the water supply after
+discharge by the POTW. Others recognize the need for POTWs to blend wastewater
+in certain temporary circumstances but say that it should not be used as a long-term
+solution in order to avoid treating peak and base flows when treatment is feasible and
+can be done according to standard engineering practice.
+
+Yet, while some are critical that the proposed policy may be too flexible, others
+
+believe that it is too restrictive. Some of these critics, including municipal officials
+and sanitary engineering professionals that support blending, believe that the
+proposal contains a number of vague or excessively broad terms that should be
+further refined, such as what is “generally accepted good engineering practice” for
+design and operation of a POTW. They also charge that the policy seeks to restrict
+discharge of blended wastes into sensitive receiving waters and that it would require
+the system operator to utilize all peak flow capacity of sewers and other storage
+devices before commencing blending. These restrictions, they say, amount to EPA
+dictating design and operations of the treatment facility, which is contrary to the
+Clean Water Act. They argue that ambiguities will allow different EPA regions to
+interpret the policy differently, resulting in inconsistencies much like those that EPA
+hopes to resolve by issuing the policy. These critics urge EPA to require that the
+policy, when completed, will be binding in all regions. On the other hand, a number
+of commenters urge EPA to do the opposite: to clarify that the final policy, as in the
+proposal, will allow states and regions the option to not authorize POTWs to blend,
+if that is their preference.
+
+A number of critics of EPA’s proposal — both those who oppose blending and
+
+others who favor it — assert that the policy represents more than just interpretation
+of current rules, that it fundamentally would change existing requirements, such as
+the bypass rule and the ability of operators (not EPA) to design and operate plants in
+order to meet permit requirements. Some of these critics share the view that in the
+2003 proposal, EPA has transformed the policy into a rulemaking. As presented in
+November, the proposal is not a formal rulemaking (which would be subject to the
+
+19 See, for example, Letter from Larson, Jeffrey H., Manager, Permitting, Compliance and
+Enforcement Program, Environmental Protection Division, Water Protection Branch,
+Georgia Department of Natural Resources. EPA Docket ID No. OW-2003-0025-0482, Jan.
+9, 2004, 6 p.
+
+ 
+ CRS-15
+
+notice and comment procedures of the Administrative Procedure Act (APA),
+although EPA did solicit public comments that it compiled in a docket), nor does it
+contain changes to current regulations. EPA characterized the policy as an
+interpretation of current rules and a draft guidance to implement such an
+interpretation. In addition, so long as the policy is not considered by EPA to be a
+rule, it is unlikely to be seen by EPA as subject to provisions of the Congressional
+Review Act (CRA, 5 U.S.C. §§801-808), which requires that before a rule can
+become final, it must be filed with the House and Senate and the General Accounting
+Office. The CRA allows Congress to disapprove agencies’ rules by enacting a joint
+resolution of disapproval.20 
+
+ Congressional Interest and Status of the Proposal 
+
+In Congress, the issues and practice of blending have drawn some Members’
+
+attention. In January 2004, during the public comment period on the proposed
+policy, Members with differing views on the proposal wrote to EPA to express
+concerns about it. In one letter, four House committee and subcommittee chairmen
+urged EPA to issue the policy, but said that the draft needs to clarify inconsistent
+regional enforcement, and as drafted, the proposal oversteps federal authority and
+bypasses the role of states in clean water decisionmaking. Further, they asserted that
+the proposal will establish “new back-door regulatory-type requirements to be
+imposed at the discretion of the permitting authority [that] will lead to less, not
+greater, national consistency.”21 These Members called for EPA to revise the
+guidance to make clear that blending is an acceptable practice and to make sure that
+the policy is implemented in a reasonable and consistent manner nationally. At the
+same time, a bipartisan letter from 64 House Members of the Congressional Coastal
+Caucus criticized the draft policy as an environmental rollback that would endanger
+public health. Focusing on the concern that blending may lead to discharges of
+microbial pathogens into waterways, the letter faulted the draft policy for not
+ensuring that disinfection be required when a POTW blends its effluent. This letter
+recognized the problem of excess flows during storms, but said that blending sewage
+is an unacceptable alternative and that treatment facilities should consider building
+
+20 For additional information, see CRS Report RL32240, The Federal Rulemaking Process:
+An Overview , by Curtis Copeland. It should be noted, however, that the CRA has a broad
+definition of the term “rule” that encompasses not only formal notice and comment
+proceedings under the APA but also policy statements, guidance, and other agency issuances
+that may have a legal or practical binding effect on the regulated public. See CRS Report
+RL30116, Congressional Review of Agency Rulemaking: An Update and Assessment After
+Nullifcation of OSHA’s Ergonomics Standard , by Mort Rosenberg, pp. 2-3.
+
+21 Letter from Don Young, Chairman, Committee on Transportation and Infrastructure, John
+J. Duncan, Jr., Chairman, Subcommittee on Water Resources and Environment, Tom Davis,
+Chairman, Committee on Government Reform, Doug Ose, Chairman, Subcommittee on
+Energy Policy, Natural Resources, and Regulatory Affairs. EPA Docket No. ID OW-2003-
+0025-0533, Jan. 7, 2004, 3 p.
+
+ 
+ CRS-16
+
+additional capacity or short-term storage until all the sewage can be treated with
+biological processes.22
+
+Congress has several possible options at this point. One is to do nothing and
+
+thus allow EPA to handle the issue administratively. A second is for congressional
+committees to conduct oversight to examine the various issues raised by the proposed
+policy. One aspect of such examination could include whether a final blending
+policy, when and if issued, is covered by the Congressional Review Act. Another
+option is to legislate in order to direct EPA’s actions, by expressly permitting,
+prohibiting, or modifying the policy. One example of such action occurred in 2000,
+when Congress codified EPA’s 1994 national CSO strategy in amendments to the
+Clean Water Act (the Wet Weather Water Quality Act; P.L. 106-554, Division B,
+Section 112). At the conclusion of the 108th Congress, a bill was introduced that was
+intended to prohibit EPA from issuing rules or guidance that would authorize
+blending, unless necessary to prevent loss of life, personal injury, or severe property
+damage. (H.R. 5421). No further action occurred on this measure.
+
+After publication of the proposed policy in November 2003, EPA solicited
+
+public comments for a 120-day period, compiling a docket with more than 98,000
+comments. Many observers had expected EPA to issue a final version of the policy
+in mid- or late-2004, but as of February 2005, EPA has not done so. Issues that
+reportedly continue to be unresolved include whether the policy will apply only to
+future CSO settlements or also to past enforcement settlements (if applied
+retroactively, the guidance could force the re-opening of consent decrees in a number
+of cases) and whether the guidance must require municipalities to conduct a “no
+feasible alternatives” analysis to prove that blending is necessary. Future challenges
+to a final policy, when and if released, are possible, especially if some stakeholders
+believe that it contains binding requirements that are burdensome or if others believe
+that it is insufficiently protective of public health and the environment.
+
+22 “Competing Hill Critiques Hand EPA Tough Choices on Blending Policy.” Inside EPA ,
+vol. 25 no. 5, Jan. 30, 2004, p. 16.
\ No newline at end of file
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--- /dev/null
+++ b/corpus/politics/text/9482c7187e727df5.txt
@@ -0,0 +1,3 @@
+Acid Rain: Does it Contribute to Forest Decline?
+
+This minibrief describes the major hypothesis explaining why acid rain may be contributing to forest decline, along with the major arguments against this hypothesis. For additional information on acid rain and current legislation for pollutant emissions controls, see IB83016 -- Acid Rain: Current Issues, and IB83005 -- Clean Air Act: An Overview.
\ No newline at end of file
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--- /dev/null
+++ b/corpus/politics/text/a138c132c2fabee2.txt
@@ -0,0 +1,1552 @@
+Order Code RL33179
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ Social Security Disability Insurance (SSDI) and 
+
+ Supplemental Security Income (SSI): Proposed 
+
+ Changes to the Disability Determination and 
+
+ Appeals Processes 
+
+ December 6, 2005 
+
+Scott Szymendera
+
+Analyst in Social Security
+
+Domestic Social Policy Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ Social Security Disability: Proposed Changes to the
+
+Disability Determination and Appeals Processes
+
+ Summary 
+
+The Social Security Administration (SSA) maintains multi-stage determination
+
+and appeals processes for applications to the Social Security Disability Insurance
+(SSDI) and Supplemental Security Income (SSI) programs. These processes begin
+with an initial determination of disability by a state agency, followed by multiple
+opportunities for administrative appeals. Unsuccessful applicants are also entitled
+to appeal their decisions to the federal courts.
+
+These processes have been criticized by the SSA, the Social Security Advisory
+
+Board, the Governmental Accountability Office, and others for the timeliness of the
+final decision, for rendering initial decisions that are reversed on appeal, and for
+inconsistency across states. 
+
+In response to these criticisms, the SSA recently proposed changes to the
+
+disability determination and appeals processes. These changes would allow clearly
+disabled applicants to get a final decision in 20 days and would bring in-line and end-
+of-line quality reviews into the processes. The reconsideration stage would be
+replaced with a review by a federal official and the Appeals Council would be
+replaced by a board that would review cases likely to contain errors. 
+
+Critics of these reforms have expressed concerns that the changes would put
+
+additional procedural burdens on persons with disabilities and make it more difficult
+for them to navigate the system and have all of the evidence in support of their cases
+heard.
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Social Security Disability Insurance and Supplemental Security Income . . . . . . . 2
+
+The Disability Determination and Appeals Processes . . . . . . . . . . . . . . . . . . . . . . 4
+
+Initial Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Hearings and Appeals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+Reconsideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Administrative Law Judge Hearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Appeals Council . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Federal Courts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+Issues Surrounding the Current Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+
+Timeliness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
+Inconsistency Across States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
+
+Proposed Changes to the Disability Determination and Appeals Processes . . . . 13
+
+Timetable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
+Proposed Quick Disability Determination (QDD) . . . . . . . . . . . . . . . . . . . . 14
+Proposed Federal Expert Unit (FEU) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
+Proposed Initial Disability Determination . . . . . . . . . . . . . . . . . . . . . . . . . . 15
+Proposed Federal Reviewing Official (RO) . . . . . . . . . . . . . . . . . . . . . . . . . 15
+Proposed Closing of the Record After the ALJ Hearing . . . . . . . . . . . . . . . 15
+Proposed Decision Review Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+Proposed Judicial Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+
+Issues Surrounding the Proposed Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+
+Proposed Additional Time Limits for Applicants . . . . . . . . . . . . . . . . . . . . 17
+
+Proposed Evidentiary Time Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+
+Proposed Changes to the Right of a Claimant to Have a Case Reopened
+
+After an ALJ Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
+
+Proposed Replacement of the Appeals Council with the Decision Review
+
+Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
+Rights of Claimants to Appeal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+Own Motion Authority of the SSA . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+Evidence Rules and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+
+Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
+
+ List of Figures 
+
+Figure 1. The Five-Step Disability Determination Process . . . . . . . . . . . . . . . . . 5
+Figure 2. SSDI and SSI Appeals, FY2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+Figure 3. Average Case Processing Times, FY2004 . . . . . . . . . . . . . . . . . . . . . . 11
+Figure 4. Proposed Disability Determination and Appeals Processes . . . . . . . . 22
+
+ 
+ List of Tables 
+
+Table 1. Reason for Final Medical Allowance, 2002 . . . . . . . . . . . . . . . . . . . . . . 6
+Table 2. Reason for Final Medical Denial, 2002 . . . . . . . . . . . . . . . . . . . . . . . . . 6
+Table 3. Allowance Rates at Each Adjudicative Level, 2002 . . . . . . . . . . . . . . . . 9
+Table 4. State Variation in Disability Allowance and Reversal Rates, 2000 . . . 13
+Table 5. State Variation in Disability Examiner Pay and Productivity . . . . . . . . 13
+
+ 
+ 
+
+Social Security Disability: Proposed
+
+Changes to the Disability Determination and
+
+Appeals Processes
+
+ Introduction 
+
+This report explains the large and complex system used by the Social Security
+
+Administration (SSA) to determine eligibility for disability benefit programs and to
+adjudicate disputes that arise from these determinations. Persons with disabilities in
+each congressional district are affected by this system. In addition, the fact that
+initial decisions are often reversed on appeal and the length of the appeals process
+places burdens on the Social Security Disability Insurance Trust Fund and the general
+revenue of the United States.
+
+The disability determination and appeals processes used by the SSA have been
+
+called the “largest system of administrative adjudication in the Western world.”1 In
+Fiscal Year (FY) 2004, the SSA and its network of state disability determination
+services processed more than 2.4 million initial Social Security Disability Insurance
+(SSDI) applications and more than 2.2 million applications for Supplemental
+Security Income (SSI) benefits. That same year, the 944 SSA Administrative Law
+Judges issued rulings on 495,029 appeals of initial disability determinations and the
+SSA Appeals Council ruled on 97,701 appeals of Administrative Law Judge
+decisions.2
+
+The number of cases appealed, and the number of these cases that result in a
+
+reversal of the initial determination, indicate that in many cases, persons with
+disabilities who meet the statutory eligibility requirements for the SSDI or SSI
+programs may not receive the benefits to which they are entitled. These claimants
+are then forced into the complex and multi-layered appeals system with its own
+procedural rules and quasi-judicial framework. For some applicants, a final decision
+on their claim can take several years.
+
+Decisions that are reversed on appeal and the length and complexity of the
+
+appeals process increase the administrative costs paid by the SSA. In the case of
+SSDI applicants, these costs are paid out of the Social Security Disability Trust Fund
+and are funded by payroll taxes whereas SSI administrative costs come from the
+general revenue of the United States. In FY2005, SSDI administrative costs are
+
+1 Lance Liebman, Disability Appeals in Social Security Programs (Washington: Federal
+Judicial Center, 1985), p. 1.
+
+2 Social Security Administration, Annual Statistical Supplement to the Social Security
+Bulletin, 2005 (Washington: GPO, 2005), pp. 2. F5, 2.F6, 2.F8, 2.F9, 2.F11.
+
+ 
+ CRS-2
+
+budgeted to be 2.6% of benefit payments whereas SSI administrative costs are
+budgeted to be 7.8% of benefit payments.3
+
+The number of initial decisions reversed on appeal and the length and
+
+complexity of the disability appeals process also have a public policy impact. In
+establishing the SSDI and SSI programs, Congress set requirements for program
+participation and the receipt of benefits and charged the SSA with the task of
+providing that persons who meet these standards are given the benefits to which they
+are entitled. However, in many cases, this is either not occurring or occurring only
+after a lengthy delay and deserving beneficiaries, who by the very nature of their
+disability and work status are often among the least well-off in society, are forced to
+navigate a long and difficult process to receive their benefits. In other cases, persons
+who do not meet the statutory definition of disability are receiving benefits because
+of inaccurate determinations or appellate decisions.
+
+To best provide readers with an understanding of the current disability
+
+determination and appeals processes as well as the changes to these processes
+proposed by the SSA, this report is organized into the following five major sections:
+
+! The first section is an overview of the SSDI and SSI programs;
+! The second section describes, in detail, the current disability
+
+determination and appeals processes;
+
+! The third section provides a discussion of the issues surrounding
+
+these processes that have been raised by observers;
+
+! The fourth section describes, in detail, the changes to these systems
+
+proposed by the SSA; and
+
+! The final section provides a discussion of some of the issues raised
+
+regarding these proposed changes.
+
+ Social Security Disability Insurance and 
+
+ Supplemental Security Income 
+
+The SSA administers two programs, SSDI and SSI, that provide income and
+
+benefits to persons unable to work because of serious disabling conditions.4 In both
+programs, disabled individuals must pass the same statutory test of disability as
+outlined in Titles II and XVI of the Social Security Act.5
+
+3 Data taken from the Social Security Administration FY2005 President’s Budget, available
+at [http://www.ssa.gov/budget/FactCard2005.pdf].
+
+4 For more information on the SSDI and SSI programs, see CRS Report RL32279, Primer
+on Disability Benefits: Social Security Disability Insurance (SSDI) and Supplemental
+Security Income (SSI) , by April Grady and Julie M. Whittaker. (Hereafter cited as CRS
+Report RL32279).
+
+5 42 U.S.C. §§ 423(d)(1) and 1382c. A person is disabled under the terms of the statute if
+he or she is unable to engage in any Substantial Gainful Activity (SGA, for 2005 earnings
+of $830 per month for non-blind persons and $1,380 per month for blind persons) because
+
+(continued...)
+
+ 
+ CRS-3
+
+The SSDI program pays benefits to disabled individuals under the provisions
+
+of Title II of the Social Security Act. SSDI benefits are paid to those who meet the
+statutory test of disability and have completed a five-month waiting period from the
+onset of disability.6 Program beneficiaries must have a sufficient work history in
+employment covered by Social Security to qualify for benefits.7 Benefits and
+administrative costs are paid out of the Social Security Disability Insurance Trust
+Fund, which is funded by a portion of the payroll taxes collected on earnings. There
+is no means test for the SSDI program. The SSDI program pays monthly benefits
+based on past earnings and, after two years, participants are eligible to receive
+Medicare hospitalization insurance (Part A) and purchase Medicare supplemental
+insurance (Part B) or enroll in a Medicare Advantage Plan.8
+
+Under the provisions of Title XVI of the Social Security Act, disabled
+
+individuals and those 65 and older are entitled to benefits from the SSI program if
+they meet the statutory test of disability and have income and assets that fall below
+levels set by program guidelines. SSI benefits are paid out of the general revenue of
+the United States and all participants receive the same basic monthly benefit.9 In
+most states, adults who collect SSI are automatically entitled to coverage under the
+Medicaid health insurance program.10
+
+5 (...continued)
+of a medically determinable physical or mental impairment. This impairment must be
+expected to result in the impaired person’s death, or be expected to last at least 12
+consecutive months. In addition, this impairment must prevent a person from engaging in
+his or her previous work or in any other work that exists in the national economy. The
+Supreme Court held in Barnhart v. Thomas 124 S. Ct. 376 (2003) that the previous work test
+does not require that an individual’s prior job exists in the national economy.
+
+6 For more information on the five-month waiting period, see CRS Report RS22220, Social
+Security Disability Insurance: The Five-Month Waiting Period for SSDI Benefits , by Scott
+Szymendera.
+
+7 A detailed explanation of the insurance requirements can be found at [http://www.ssa.gov/
+dibplan/dqualify3.htm] and in CRS Report RL32279.
+
+8 For more information, see CRS Report RS22195, Social Security Disability Insurance
+(SSDI) and Medicare: The 24-Month Waiting Period for SSDI Beneficiaries Under Age of
+65 , by Julie M. Whittaker.
+
+9 The basic monthly federal benefit amount for 2005 is $579 for a single person and $869
+for a couple. This amount is supplemented by 44 states and the District of Columbia.
+Arizona, Georgia, Kansas, Mississippi, the Commonwealth of the Northern Mariana Islands,
+Tennessee, and West Virginia do not offer a state supplement. A participant in the SSI
+program receives the federal benefit amount, plus any state supplement, minus any
+countable income. SSI benefits are not available to residents of Puerto Rico, Guam, or the
+United States Virgin Islands. Residents of these jurisdictions are eligible to receive federal
+benefits from their commonwealth or territorial government under provisions of Title XIV
+and Title XVI of the Social Security Act. These benefits are administered by the
+Department of Health and Human Services.
+
+10 Thirty-nine states, the District of Columbia, and the Commonwealth of the Northern
+Mariana Islands grant Medicaid eligibility to all adult SSI recipients, or have Medicaid
+eligibility rules that are the same as those of the SSI program. For more information, see
+
+(continued...)
+
+ 
+ CRS-4
+
+ The Disability Determination and 
+
+ Appeals Processes 
+
+Decisions on applications to SSDI and SSI require that evaluations be made
+
+about the severity of reported disabling conditions. These tasks are complicated by
+the fact that scholars and advocates continue to struggle to define the concept of
+disability, the nature of impairment, and how different conditions can limit essential
+life and work activities.11 This differs from the Social Security retirement program,
+which needs only to confirm an applicant’s age and insured status before paying out
+benefits.
+
+ Initial Determination 
+
+The disabled worker submits an application to the SSA. The evaluation of
+
+disability takes place in the appropriate state Disability Determination Services
+(DDS) office. The DDS is a state agency with state employees who evaluate SSDI
+and SSI applications according to federal guidelines. The DDS determines whether
+someone is disabled according to a five-step sequential evaluation process. Current
+work activity, severity of impairment, and vocational factors are assessed in that
+order. An applicant may be denied benefits at any step in the sequential process even
+if the applicant may meet a later criterion. For example, a worker that meets the
+medical listings for disability but earns an amount exceeding the Substantial Gainful
+Activity (SGA) earnings limit would be denied benefits at Step 1. The five steps are
+as follows and are depicted in Figure 1 .
+
+! Step 1. Work test . Is the individual working and earning over SGA?
+
+If yes, the application is denied. If no, the application moves to Step
+2.
+
+! Step 2. Severity test . Is the applicant’s condition severe enough to
+
+limit basic life activities for at least one year? If yes, the application
+moves to Step 3. If not, the application is denied. 
+
+! Step 3. Medical listings test . Does the condition meet SSA’s
+
+medical listings, or is the condition equal in severity to one found on
+the medical listings?12 If yes, the application is accepted and
+benefits are awarded. If no, the application moves to Step 4.
+
+10 (...continued)
+[http://www.ssa.gov/work/ResourcesToolkit/Health/medicaid.html].
+
+11 For an overview of this debate, see Barbara M. Altman, “Disability Definitions, Models,
+Classification Schemes, and Applications,” in Gary L. Albrecht, Katherine D. Seelman, and
+Michael Bury, Handbook of Disability Studies (Thousand Oaks, CA: Sage Publications,
+2001).
+
+12 The medical listings can be found in the Social Security Administration publication
+ Disability Evaluation Under Social Security , available at [http://www.ssa.gov/disability/
+professionals/bluebook/Entire-Publication1-2005.pdf]. This publication is commonly
+referred to as the SSA Blue Book . (Hereafter cited as SSA Blue Book .)
+
+ 
+ 
+
+CRS-5
+
+! Step 4. Previous work test . Can the applicant do the work he or she
+
+had done in the past? If yes, the application is denied. If not, the
+application moves to Step 5.13
+
+! Step 5. Any work test . Does the applicant’s condition prevent him
+
+or her from performing any other work that exists in the national
+economy? If yes, the application is accepted and benefits are
+awarded. If no, the application is denied.
+
+ Figure 1. The Five-Step Disability Determination Process 
+
+ Source: The Congressional Research Service (CRS).
+
+Meeting or exceeding the medical listings is the most common reason why
+
+applications to the SSDI and SSI programs are accepted. In 2002, over 44% of SSDI
+applicants and 53% of SSI applicants were admitted to the disability rolls because of
+successfully meeting the medical listing test (Step 3 of the five step evaluation
+process). Among those denied entry into the programs, the most common reason was
+for failing the any work test found in Step 5 with over 30% of all SSDI denials and
+24% of all SSI denials occurring at this stage.14 Table 1 summarizes the reasons for
+final medical allowances. For example, 37.3% of those admitted into the SSDI
+program met the severity of the medical listings and an additional 7% of those
+admitted were judged to have a condition that is equal in severity to one found in the
+medical listings.
+
+13 Cases of children applying for SSI benefits are not subject to the work test but instead to
+a test of functional capacity.
+
+14 Social Security Administration, Annual Statistical Report on the Social Security Disability
+Insurance Program, 2003 (Washington: GPO, 2004), pp. 137-138; SSI Annual Statistical
+Report, 2003 (Washington: GPO, 2004), pp. 123-124.
+
+ 
+ CRS-6
+
+ Table 1. Reason for Final Medical Allowance, 2002 
+
+(by year of application)
+
+ Medical and 
+
+ Equals 
+
+ vocational 
+
+ Meets severity 
+
+ severity of 
+
+ factors 
+
+ Program 
+
+ of listings 
+
+ listingsa 
+
+ combined 
+
+ Otherb 
+
+Social Security Disability
+
+37.3%
+
+7.0%
+
+38.9%
+
+16.8%
+
+Insurance (SSDI)
+
+Supplemental Security Income
+
+38.8%
+
+15.7%
+
+24.4%
+
+21.0%
+
+(SSI)
+
+ Source: Table prepared by the Congressional Research Service (CRS) from data provided by Social
+Security Administration, Annual Statistical Report on the Social Security Disability Insurance
+Program, 2003 , (Washington: GPO, 2004), p. 137; SSI Annual Statistical Report, 2003 (Washington:
+GPO, 2004), p. 123.
+
+a. Includes SSI child cases that functionally equal the level of severity of listings.
+b. Includes cases in which a disability was previously established or for which no information is
+
+available.
+
+ Table 2 summarizes the reasons for final medical denials. For example, 16.9%
+
+of those denied entry into the SSDI program were denied because their impairments
+were not judged to be sufficiently severe.
+
+ Table 2. Reason for Final Medical Denial, 2002 
+
+(by year of application)
+
+ Impairment 
+
+ Impairment 
+
+ did not or is 
+
+ does not 
+
+ Able to 
+
+ not expected 
+
+ cause severe 
+
+ Able to 
+
+ do other 
+
+ to last 12 
+
+ Impairment 
+
+ functional 
+
+ do past 
+
+ type 
+
+ Program 
+
+ months 
+
+ not severe 
+
+ limitationsa 
+
+ workb 
+
+ workb 
+
+ Otherc 
+
+Social Security
+Disability
+
+9.1%
+
+16.9%
+
+ — 
+
+27.9%
+
+30.2%
+
+16.0%
+
+Insurance (SSDI)
+
+Supplemental
+Security Income
+
+5.8%
+
+12.6%
+
+17.8%
+
+15.7%
+
+24.2%
+
+23.9%
+
+(SSI)
+
+ Source: Table prepared by the Congressional Research Service (CRS) from data provided by Social
+Security Administration, Annual Statistical Report on the Social Security Disability Insurance
+Program, 2003 (Washington: GPO, 2004), p. 138; SSI Annual Statistical Report, 2003 (Washington:
+GPO, 2004), p. 125.
+
+a. Used only for SSI applicants under the age of 18.
+b. Applies only to SSI applicants over the age of 18 and all SSDI applicants.
+c. Includes cases denied for reasons of substance abuse, cases in which an applicant did not supply
+
+sufficient information or failed to cooperate with regulations, cases in which an applicant
+returned to work during processing, and cases denied for unspecified reasons.
+
+ 
+ CRS-7
+
+ Hearings and Appeals 
+
+Applicants to the SSI and SSDI programs who are dissatisfied with the decisions
+
+of the DDS may appeal their cases. In FY2004, approximately 63% of applications
+to the SSI and SSDI programs were denied and nearly 35% of those denied filed an
+appeal of their denial.15 The appeals process begins with a reconsideration of the
+decision, followed by an Administrative Law Judge hearing, a decision by the
+Appeals Council, and a hearing in the federal court system. 
+
+ Reconsideration. After the initial denial by the DDS, an applicant may ask
+
+for a reconsideration by a different DDS officer in his or her state. During this first
+appellate stage, the entire application and record of the applicant is reviewed as if it
+were a new case. The SSA is currently running a prototype project in 10 states that
+eliminates this reconsideration step.16 In FY2004, approximately 14% of cases
+reconsidered by the DDS resulted in a reversal of the previous denial of benefits. 
+
+ Administrative Law Judge Hearing. If the applicant is not satisfied with
+
+the decision at the reconsideration stage, he or she may ask for a hearing before an
+SSA Administrative Law Judge (ALJ) within 60 days of the reconsideration decision.
+During this hearing, held either in person or via video conference, the applicant has
+the opportunity to present his or her case and any evidence to support the appeal.
+The SSA is not represented at this hearing and can not contest the applicant or the
+evidence. Although a case is officially closed after the decision of the ALJ, the ALJ
+does have some authority to reopen a case if new evidence is presented. In FY2004,
+63% of cases heard by an ALJ resulted in a favorable decision for the claimant.
+
+ Appeals Council. The decision of the ALJ may be appealed by the applicant
+
+to the SSA Appeals Council within 60 days. The Appeals Council may either review
+a case or let the decision of the ALJ stand. The Appeals Council conducts a review
+of the ALJ hearing and decision and though the applicant may be present and give
+a statement, the Appeals Council does not conduct a formal hearing. The Appeals
+Council can decide to let the previous decision stand, remand the case back to an ALJ
+for a new decision, or reverse the decision of the ALJ. In FY2004, the Appeals
+Council ruled on only 4% of all initial applications and awarded benefits in 25% of
+these cases.
+
+ Federal Courts. The Appeals Council is the final administrative step in the
+
+SSA appeals process. Applicants dissatisfied with the decision of the Appeals
+Council or ALJ may file a case in the United States District Court within 60 days of
+the decision; an unfavorable decision in the District Court can be appealed to the
+United States Court of Appeals and United States Supreme Court. Less than 1% of
+all applications for benefits end up in the federal court system and only a handful of
+
+15 Data taken from the website of the Social Security Administration and available at
+[http://www.ssa.gov/disability/disability_process_welcome_2004.htm].
+
+16 The Disability Redesign Prototype began in 1999 and is currently operating statewide in
+Alabama, Alaska, Colorado, Louisiana, Michigan, Missouri, New Hampshire, New York
+and Pennsylvania; and in the Los Angeles area of California.
+
+ 
+ CRS-8
+
+cases are appealed to the United States Court of Appeals.17 The last petition for the
+ writ of certiorari of a disability determination case granted by the United States
+Supreme Court came in 2003 in the case of Barnhart v. Thomas , and the denial of
+benefits in this case was upheld by the Court.18
+
+ Figure 2 summarizes the number of cases appealed at each stage of the process
+
+and is based on aggregate data for FY2004. During this fiscal year, 37 out of every
+100 applications resulted in a favorable decision at the initial determination stage of
+the process. Of these 100 applicants, 22 appealed their initial denial to the
+reconsideration stage where 3 applications were accepted. Of the initial 100
+applicants, 19 appealed to the ALJ stage and 4 appealed to the Appeals Council.
+Ultimately, of these 100 applications, 53 were awarded benefits, with 37 of those
+awards coming at the initial determination stage, 3 at the reconsideration stage, 12
+at the ALJ stage, and 1 at the Appeals Council stage.
+
+ Figure 2. SSDI and SSI Appeals, FY2004 
+
+ 100 
+
+ 90 
+
+37
+
+ 80 
+
+ 70 
+
+ Allowances 
+
+ 60 
+
+ Cases 
+
+ Denials 
+
+ 50 
+
+ ge of
+a 
+
+ ent 40 
+
+ c 
+
+ Per 
+
+ 22 APPEAL 
+
+ 19 APPEAL 
+
+ 4 APPEAL 
+
+63
+
+ 30 
+
+ 20 
+
+3
+
+12
+
+ 10 
+
+19
+
+1
+
+7
+
+ 0 
+
+3
+
+ Initial Claims 
+
+ Reconsiderations 
+
+ Hearings 
+
+ Appeals Council 
+
+ Review 
+
+ Source: The Congressional Research Service (CRS). Data taken from the SSA at
+[http://www.ssa.gov/disability/disability_process_welcome_2004.htm].
+
+ Note: Aggregate data for FY2004, not a tracking of individual cases.
+
+17 Administrative Office of the United States Courts, Federal Judicial Caseload Statistics,
+March 31, 2004 (Washington: GPO, 2005), pp. 30-34, 43-44.
+
+18 124 S. Ct. 376 (2003).
+
+ 
+ CRS-9
+
+ Table 3 summarizes the allowance rate at each stage of the process for 2002.
+
+During that year, nearly 78% of SSDI and just over 64% of SSI cases heard by ALJ’s
+resulted in allowances.
+
+ Table 3. Allowance Rates at Each Adjudicative Level, 2002 
+
+ ALJ Hearing 
+
+ Program 
+
+ Initial DDS 
+
+ Reconsideration 
+
+ and above 
+
+Social Security Disability Insurance
+
+38.2%
+
+10.5%
+
+77.9%
+
+(SSDI)
+
+Supplemental Security Income (SSI)
+
+36.7%
+
+10.1%
+
+64.1%
+
+ Source: The Congressional Research Service (CRS). Table from data provided by Social Security
+Administration, Annual Statistical Report on the Social Security Disability Insurance Program, 2003 ,
+(Washington: GPO, 2004), pp. 136-138; SSI Annual Statistical Report, 2003 (Washington: GPO,
+2004), pp. 117-119.
+
+ Issues Surrounding the Current Processes 
+
+Researchers and others, including the nonpartisan Social Security Advisory
+
+Board,19 have raised the following issues with respect to the disability determination
+and appeals process:
+
+! timeliness, 
+! accuracy, and
+! national consistency of the decisions made. 
+
+In addition, the Commissioner of Social Security has testified about the
+
+problems caused by the lack of timeliness and the number of initial decision reversed
+on appeal in the current processes.20
+
+19 The Social Security Advisory Board was created in 1994 with the passage of the Social
+Security Independence and Program Improvements Act of 1994, P.L. 103-296. The Board
+is made up of seven members who serve six year staggered terms. Three members of the
+Board are appointed by the President with the advice and consent of the Senate with no
+more than two of these members being from the same political party. Two members, one
+from each party are appointed by the President pro tempore of the Senate with the advice
+of the Chairman and Ranking Member of the Committee on Finance. Two members, one
+from each party, are appointed by the Speaker of the House with the advice of the Chairman
+and Ranking Member of the Committee on Ways and Means.
+
+20 U.S. Congress, House Committee on Ways and Means, Testimony Social Security
+Commissioner, Jo Anne B. Barnhart, Social Security Administration’s Management of the
+Office of Hearings and Appeals , hearings, 108th Cong. (2003). 
+
+ 
+ CRS-10
+
+ Timeliness 
+
+Some observers, including the Social Security Advisory Board, are concerned
+
+about the length of time involved in the entire disability determination and appeals
+processes.21 In addition, the Government Accountability Office (GAO) and others
+have commented that the length of the determination and appeals process is a
+contributing factor to the historically low return to work rates of SSDI and SSI
+beneficiaries.22 Although successful applicants can receive benefits retroactive to the
+date of application, during the determination and appeals processes they are not
+working and receive no medical or cash benefits through the SSDI or SSI programs.
+
+In FY2004, applicants waited an average of 95 days for an initial determination
+
+of their disability status from the state DDS agency. Reconsiderations by the DDS
+took an average of 97 additional days. After requesting a hearing before an ALJ,
+claimants waited an average of 394 days before getting a decision and the wait or a
+decision from the Appeals Council took an average of 251 additional days. When
+time spent on due process concerns and making appointments is included, a disability
+claim that was considered at each stage of the determination and appeals processes
+averaged 1,048 days to be resolved by the SSA.23
+
+21 General Accounting Office, SSA Disability Redesign: Focus Needed on Incentives Most
+Crucial to Reducing Costs and Time, GAO /HEHS-97-20 (Washington: GPO, 1997);
+General Accounting Office, Social Security Disability: Disappointing Results from SSA’s
+Efforts to Improve the Disability Claims Process Warrant Immediate Attention
+ (Washington: GPO, 2002); Social Security Advisory Board, How SSA’s Disability Programs
+Can be Improved (Washington: GPO, 1998).
+
+22 Monroe Berkowitz, “Improving the Return to Work of Social Security Disability
+Beneficiaries,” in Jerry L. Mashaw, et al., Disability Work and Cash Benefits, (Kalamazoo,
+MI: W. E. Upjohn Institute for Employment Research, 1996); Richard V. Burkhauser and
+David Wittenburg, “How Current Disability Transfer Policies Discourage Work: Analysis
+from the 1990 SIPP,” Journal of Vocational Rehabilitation , vol. 7 (1996), pp. 9-27; General
+Accounting Office, SSA Disability: Program Redesign Necessary to Encourage Return to
+Work, GAO/HEHS 96-62 (Washington: GPO, 1996); General Accounting Office, Social
+Security: Disability Programs Lag in Promoting Return to Work, GAO/HEHS-97-46
+ (Washington: GPO, 1997); Joann Sim, “Improving Return-to-Work Strategies in the United
+States Disability Programs, With Analysis of Program Practices in Germany and Sweden,”
+ Social Security Bulletin, vol. 59, no. 3 (1999), pp. 41-50. 
+
+23 Social Security Administration, Fiscal Year 2004 Performance and Accountability Report
+ (Washington: GPO 2005), p. 17.
+
+ 
+ CRS-11
+
+ Figure 3. Average Case Processing Times, FY2004 
+
+1200
+
+ Total 1048 Days 
+
+1100
+
+1000
+
+ Due 
+
+ Process/Appointments 
+
+900
+
+ 211 Days 
+
+800
+
+ Appeals Council 
+
+700
+
+ 251 Days 
+
+ S
+Y 
+
+600
+
+ DA 
+
+500
+
+400
+
+ ALJ Hearing 394 Days 
+
+300
+
+200
+
+ Reconsideration 97 
+
+ Days 
+
+100
+
+ Initial Decision 95 
+
+ Days 
+
+0
+
+ Source: CRS figure from data provided by Social Security Administration, Fiscal Year 2004
+Performance and Accountability Report (Washington: GPO, 2005), p. 17.
+
+ Note: Due Process/Appointments includes time taken by applicants to file appeals and make
+appointments and can occur at any stage in the process.
+
+ Accuracy 
+
+Ensuring that initial and appellate disability decisions, both allowances and
+
+denials, are accurate is one of the key goals identified by the SSA in its FY2004
+Performance and Accountability Report. Using data from its own internal quality
+assurance system, which re-examines a sample of decided cases, the SSA estimates
+that 96.5% of initial disability determinations were accurate based on the evidence
+presented at the time of the determination. The SSA also reports that the accuracy
+rate for decisions made by Administrative Law Judges is 90%.24 Despite this
+assertion, in 2003, Administrative Law Judges, the Appeals Council, and the Federal
+Courts reversed initial decisions in over 78% of the SSDI cases they heard and 64%
+of the SSI cases they heard.25 In many cases, this is due to additional evidence not
+presented at the initial determination stage.
+
+24 Social Security Administration, FY2004 Performance and Accountability Report
+ (Washington: GPO, 2005), pp. 91-92.
+
+25 Social Security Administration, Annual Statistical Report on the Social Security Disability
+Insurance Program, 2003 (Washington: GPO, 2004), pp. 134-136; SSI Annual Statistical
+Report, 2003 (Washington: GPO, 2004), pp. 117-122.
+
+ 
+ CRS-12
+
+Some researchers have suggested that SSA disability decisions are not as
+
+accurate as the agency claims they are. An external study commissioned by the SSA
+in 1994 found serious flaws in the quality assurance process at the agency.26 In
+addition, a 2004 report that used self-reported disability data to examine the accuracy
+of initial and appellate decisions between 1992 and 1996 concluded that
+approximately 20% of SSI and SSDI applicants from that time period who ultimately
+received benefits were not disabled, while 60% of those ultimately denied benefits
+were disabled.27
+
+ Inconsistency Across States 
+
+Initial disability determinations for SSDI and SSI applicants are made by
+
+independent state DDS offices. Although these offices are funded by the SSA,
+disability determinations are made by state employees. These state employees make
+determination decisions based on the statutory definition of disability found in Titles
+II and XVI of the Social Security Act and the Social Security publication Disability
+Evaluation Under Social Security .28 Despite this federal guidance, the Social
+Security Advisory Board has found inconsistencies across the states in
+
+! DDS allowance rates; 
+! rates of reversal of DDS decisions on appeal; and
+! DDS employee pay and productivity. 
+
+Although there is evidence that disability rates vary by state, differences in the
+
+reversal rates on appeal of state DDS decisions point to some inconsistencies at the
+initial determination level.29 Data on state variation in DDS determinations and
+reversal rates can be found in Table 4 . For example, 59% of SSI applications were
+approved in the initial decision stage by the DDS in New Hampshire, compared to
+27% in West Virginia.
+
+26 The Lewin Group, Inc., Paul Ettinger McCarthy Associates, L.L.C., and Cornell
+University, Evaluation of SSA’s Disability Quality Assurance (QA) Processes and
+Development of QA Options That Will Support the Long-Term Management of the Disability
+Program: Final Report (Falls Church, VA: The Lewin Group, Inc., 2001).
+
+27 Hugo Benitez-Silva, Moshe Buchinsky, and John Rust, How Large Are the Classification
+Errors in the Social Security Awards Process? NBER Working Paper 10219 (Cambridge,
+MA: National Bureau of Economic Research, 2004).
+
+28 SSA Blue Book .
+
+29 John L. McCoy, Miles Davis, and Russell E. Hudson, “Geographic Patterns of Disability
+in the United States,” Social Security Bulletin , vol. 57, no. 1, (1994), pp. 25-36; William J.
+Nelson, Jr., “Disability Trends in the United States: A National and Regional Perspective,”
+ Social Security Bulletin , vol. 57, no. 3 (1994), pp. 27-41. 
+
+ 
+ CRS-13
+
+ Table 4. State Variation in Disability Allowance and Reversal 
+
+ Rates, 2000 
+
+ SSI Initial Decision 
+
+ SSDI Initial Decision 
+
+ Allowance 
+
+ Allowance 
+
+ Administrative Law 
+
+ Rate 
+
+ Rate 
+
+ Judge Reversal Rate 
+
+Highest state
+
+59% (NH)
+
+65% (NH)
+
+86% (ME)
+
+Median
+
+39%
+
+45%
+
+66%
+
+Lowest state
+
+27% (WV)
+
+31% (TX)
+
+35% (DC)
+
+ Source: The Congressional Research Service (CRS). Data taken from Social Security Advisory
+Board, Disability Decision Making, Data and Materials (Washington: GPO, 2001), pp. 51, 70.
+
+ Note: Reversal rates do not account for dismissed cases.
+
+ Table 5 provides data on DDS pay and productivity. In the table, disability
+
+examiners in Connecticut were the highest paid in the country with average salaries
+of $70,000.
+
+ Table 5. State Variation in Disability Examiner 
+
+ Pay and Productivity 
+
+ Average Disability Examiner 
+
+ Decisions per staff year, 
+
+ annual salary, FY1999 
+
+ FY2000 
+
+Highest State
+
+$70,000 (CT)
+
+356 (MS)
+
+National Average
+
+$45,000
+
+250
+
+Lowest State
+
+$30,000 (SD)
+
+196 (MI)
+
+ Source: The Congressional Research Service (CRS). Data taken from Social Security Advisory
+Board, Disability Decision Making, Data and Materials (Washington: GPO, 2001), pp. 64, 67.
+
+ Note: Decisions per staff year is calculated as total number of decisions made divided by the number
+of employees.
+
+ Proposed Changes to the Disability Determination 
+
+ and Appeals Processes 
+
+On May 25, 2003, Commissioner of Social Security, Jo Anne B. Barnhart,
+
+announced in testimony to the House Committee on Ways and Means that the SSA
+would undertake fundamental reform of the disability determination and appeals
+processes. This reform effort has two stated goals:
+
+! To make the right decision as early in the process as possible; and
+
+ 
+ CRS-14
+
+! To foster return to work at all stages of the process.30
+
+After announcing this new reform effort, the Commissioner met with several
+
+Members of Congress and organizations representing people with disabilities,
+beneficiaries, claimants’ attorneys, and SSA and DDS employees. Based on these
+meetings, the initial reform plan discussed in 2003 was slightly revised and new rules
+were proposed. These proposed new rules would make a series of changes to the
+current Social Security disability determination and appeals processes used by
+applicants to the SSI and SSDI programs. Figure 4 , in the Appendix , contains a
+graphical overview of the proposed disability adjudication and appeals processes.
+
+ Timetable 
+
+The proposed changes to the disability determination and appeals processes
+
+were formally introduced, in the form of a Notice of Proposed Rulemaking, in the
+ Federal Register on July 27, 2005. As required by the Administrative Procedures
+Act,31 the SSA gave the public 90 days from the date of the NPRM to submit
+comments on the rules. This public comment period ended on October 25, 2005. In
+her hearing testimony, the Commissioner indicated that the SSA will review these
+comments and expects to announce final rules that incorporate them sometime in
+January, 2006. These rules would then be implemented during the Spring of 2006.
+The NPRM states that this implementation would begin in one of the smaller of the
+SSA’s geographical regions. The Commissioner testified that the SSA would wait
+at least one year after implementation in one region before implementing the new
+rules nationwide and would use this time to evaluate the impact of the new rules.
+Each stage of the proposed new processes is discussed in detail below.
+
+ Proposed Quick Disability Determination (QDD) 
+
+All initial disability claims would be screened by the SSA, and those deemed
+
+likely to meet the statutory definition of disability and to have readily available
+supporting evidence would be transferred to a Quick Disability Determination (QDD)
+unit established in each state. The unit would have 20 days to evaluate each case and
+either award benefits or transfer the case back to the state DDS for standard
+processing. All positive determinations made by this unit would be made in
+consultation with a medical or psychological expert who meets a set of standards
+established by the SSA. This differs from the current process, which has no
+expedited system for handling cases likely to meet the definition of disability.
+
+30 Testimony of Social Security Commissioner Jo Anne B. Barnhart, in U.S. Congress,
+House Committee on Ways and Means, Social Security Administration’s Management of
+the Office of Hearings and Appeals , hearings, 108th Cong., 1st sess., Sept. 25, 2003, Serial
+No. 108-40 (Washington: GPO, 2003). 
+
+31 5 U.S.C. § 553.
+
+ 
+ CRS-15
+
+ Proposed Federal Expert Unit (FEU) 
+
+A Federal Expert Unit (FEU) would be established to assist with disability
+
+determinations at all levels of the administrative process. The FEU would be
+operated by the SSA and would oversee a national network of medical and vocational
+experts that would meet specific standards set by the SSA. The FEU, or experts from
+the national network, would serve as consultants at all levels of the administrative
+process. Experts currently employed by DDS agencies would be eligible to join the
+national network if they meet the standards set by the SSA. The goal of the FEU and
+the national network is to ensure that decision-makers at all stages of the
+determination and appeals processes have access to experts who meet one set of
+consistent national standards. This differs from the current process in which each
+DDS agency is free to use their own experts who do not have to meet any national
+standards.
+
+ Proposed Initial Disability Determination 
+
+Cases not decided by the Quick Disability Determination Unit would be
+
+processed by state disability determination services agencies. With the exception of
+the assistance of the FEU, this process would remain unchanged.
+
+ Proposed Federal Reviewing Official (RO) 
+
+The current reconsideration step would be eliminated and replaced with a review
+
+by a Federal Reviewing Official (RO). The RO would be a lawyer and an employee
+of the SSA. An applicant dissatisfied with the decision of the state DDS would be
+able to request a review by the RO. The RO would review the decision of the DDS
+but would not hold a hearing or meet with the applicant in person. The RO could
+collect evidence and order a consultative examination with the assistance of the FEU.
+The RO could reverse, remand, modify, or affirm the decision of the DDS. In cases
+where the RO would reverse the decision of the DDS, the evidence in the case would
+have to be reviewed by the FEU. All decisions made by the RO would have to be in
+writing and would be sent to the DDS and used by the SSA for quality control
+purposes.
+
+ Proposed Closing of the Record After the ALJ Hearing 
+
+Applicants dissatisfied with the decision of the RO would continue to be able
+
+to request a hearing before an ALJ. As is currently the case, this would be a de novo
+ hearing in which the applicant could bring forward any new evidence that he or she
+feels is material. However, an applicant would be required to present all evidence
+to the ALJ no later than 20 days before the date of the hearing. In most cases, the
+decision of the ALJ would be final and would close the record. With limited
+exceptions, no new evidence could be considered after the decision of the ALJ had
+been made. The decision of the ALJ would have to be in writing and would have to
+specify why the ALJ agrees or disagrees with the decision of the RO.
+
+ 
+ CRS-16
+
+ Proposed Decision Review Board 
+
+The Appeals Council would be eliminated and replaced by a Decision Review
+
+Board made up of experienced ALJs and other adjudicators appointed to staggered
+terms by the SSA. The Decision Review Board would not review cases decided by
+ALJs on appeal, but would use a computer screening model to identify ALJ decisions
+likely to contain errors or likely to result in a review by the federal courts. The
+Decision Review Board would have the authority to affirm, modify, or reverse the
+decisions of ALJs, even when those decisions were favorable to applicants. Cases
+dismissed by the ALJ would be heard by the Decision Review Board on appeal
+because these cases are not subject to review by the federal courts.32 The decision of
+the Decision Review Board would be in writing and would specify the reasons for
+the decision. The Decision Review Board would have 90 days to rule on any case.
+After 90 days, if no ruling is made, the decision of the ALJ stands.
+
+ Proposed Judicial Review 
+
+A claimant dissatisfied with the decisions of either the ALJ or the Decision
+
+Review Board would retain his or her current right to ask for a judicial review of the
+SSA’s decision in the United States District Court. Claimants would have 90 days
+from the date of the ALJ decision, rather than the current 60 days, to file for this
+review.
+
+ Issues Surrounding the Proposed Rules 
+
+On September 27, 2005, the Subcommittees on Human Resources and Social
+
+Security of the House Committee on Ways and Means held a joint hearing on the
+proposed changes to the disability determination and appeals processes.33
+Representatives from the judicial, disability advocacy, and legal communities
+testified as to the strengths and weaknesses of the proposed changes.34 This
+testimony, and the public statements of the groups, raised three dominant issues as
+having the potential to negatively affect persons with disabilities as they navigate the
+proposed determination and appeals processes. The issues include
+
+! the imposition of additional time limits on applicants; 
+! the closing of the record after the ALJ hearing; and
+! the elimination of the Appeals Council.
+
+32 The ALJ may make a decision on a case or dismiss it entirely. Dismissals can not be
+appealed to the federal courts.
+
+33 U.S. Congress, House Committee on Ways and Means, Subcommittee on Human
+Resources and the Subcommittee on Social Security, Joint Hearing on Commissioner of
+Social Security’s Proposed Improvements to the Disability Determination Process , 109th
+Cong., 1st sess., Sept. 27, 2005 (not yet available).
+
+34 A complete list of witnesses and copies of all testimony is available on the website of the
+House Committee on Ways and Means at [http://waysandmeans.house.gov/hearings.asp?
+formmode=detail&hearing=442&comm=4].
+
+ 
+ CRS-17
+
+ Proposed Additional Time Limits for Applicants 
+
+The proposed rules include several binding time limits that applicants would
+
+have to follow; otherwise, they would lose the right to pursue their appeals or present
+evidence in support of their cases. Although these time limits are designed to shorten
+the length of the appeals process, they could limit the current flexibility applicants
+have to schedule hearings and prepare their cases. The National Organization of
+Social Security Claimants’ Representatives (NOSSCR), a group that represents
+lawyers who handle disability appeals, fears that these time limits could become
+“procedural traps” for claimants who do not have legal representation.35
+
+The proposed rules would add the following time limits:
+
+! 10 days from the receipt of a notice of the date of an ALJ hearing to
+
+object to the time or place of the hearing;36
+
+! 10 days to object to the issues specified in the notice of the ALJ
+
+hearing;37
+
+! 20 days before the date of an ALJ hearing to request that witnesses
+
+be subpoenaed;38
+
+! 10 days to submit new evidence after the decision of the ALJ;39
+! 10 days after a case is dismissed to ask the ALJ to vacate the
+
+dismissal;40 and
+
+! 10 days from the receipt of a notice that the Decision Review Board
+
+will review a case to submit a written statement to the Decision
+Review Board.41
+
+None of the proposed time limits could be waived by an ALJ, and none of the
+
+proposed rules include any provisions for a good cause or other extension.
+
+ Proposed Evidentiary Time Limit. In addition to the time limits mentioned
+
+above, the new rules propose a time limit for the submission of evidence to an ALJ.
+Section 205 of the Social Security Act provides that the decision of an ALJ shall be
+
+35 National Organization of Social Security Claimants Representatives, NOSSCR Comments
+on Proposed Changes to Disability Claim Review Process , Oct. 25, 2005, available on
+NOSSCR’s website at [http://www.nosscr.org/NOSSCRdibfinal.pdf].
+
+36 20 CFR § 405.317 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+37 Ibid.
+
+38 20 CFR § 405.332 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+39 20 CFR § 405.373 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+40 20 CFR § 405.382 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+41 20 CFR § 405.425 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+ 
+ CRS-18
+
+made “on the basis of evidence adduced at the hearing.”42 Current regulations do not
+specify any timetable for the submission of evidence and allow the ALJ to make a
+judgement based on evidence presented before a hearing or during the hearing itself.
+
+The proposed rules would require that all evidence be submitted by a claimant
+
+no later than 20 days before the date of an ALJ hearing. Under this proposed rule,
+a claimant would not be given the opportunity to present new evidence at the hearing
+and evidence submitted after the 20-day deadline would not be considered unless the
+ALJ believes that the claimant had good cause, as specified in the new rules, for
+missing the deadline.
+
+The Consortium for Citizens with Disabilities and NOSSCR both raised
+
+concerns at the hearing that claimants could be penalized for an inability to gather
+medical evidence in time, even if this delay was through no fault of their own.43 In
+addition to the procedural burden this deadline might place on a claimant, NOSSCR
+believes that this rule violates the “adducement” clause of the Social Security Act and
+previous rulings of the United States Court of Appeals that have required ALJ’s to
+fully develop the record of a case before making a decision.44
+
+ Proposed Changes to the Right of a Claimant to 
+Have a Case Reopened After an ALJ Decision 
+
+The new disability determination and appeals processes proposed in the NPRM
+
+would significantly change the rights of claimants to have their cases reopened after
+the decision of an ALJ, with the goal of bringing some finality to the administrative
+phase of the appeals process. Several witnesses at the hearing testified as to the
+hardship this could place on applicants who have legitimate claims for benefits but
+who are unable to submit evidence in time to have it considered.45
+
+ Current Rules to Reopen a Case. 46 Under the current rules, the decision
+
+of the ALJ can be reopened either at the request of the SSA or the claimant. The
+
+42 405 U.S.C. 405(b)(1).
+
+43 Commissioner of Social Security’s Proposed Improvements to the Disability
+Determination Process, Joint Hearing Before the Subcommittee on Human Resources and
+the Subcommittee on Social Security, House Committee on Ways and Means , 109th Cong.
+(2005), (statement of Marty Ford, Consortium for Citizens with Disabilities and statement
+of Thomas D. Sutton, National Organization of Social Security Claimants’ Representatives).
+
+44 National Organization of Social Security Claimants Representatives, NOSSCR Comments
+on Proposed Changes to Disability Claim Review Process , October 25, 2005, available on
+NOSSCR’s website at [http://www.nosscr.org/NOSSCRdibfinal.pdf].
+
+45 Commissioner of Social Security’s Proposed Improvements to the Disability
+Determination Process, Joint Hearing Before the Subcommittee on Human Resources and
+the Subcommittee on Social Security, House Committee on Ways and Means , 109th Cong.
+(2005), (statement of Marty Ford, Consortium for Citizens with Disabilities, statement of
+Thomas D. Sutton, National Organization of Social Security Claimants’ Representatives,
+and statement of Frank S. Bloch, Vanderbilt University School of Law).
+
+46 20 CFR §§ 404.987-404.989.
+
+ 
+ CRS-19
+
+SSA or the claimant can request that an ALJ reopen a case for any reason if the
+request is made within 12 months of the initial ALJ decision. In addition, the SSA
+or the claimant can request that an ALJ reopen a case at any time, up to four years
+after the initial decision, if there is good cause as defined in the regulations. “Good
+cause” is defined as occurring when one of the following has occurred:
+
+! New and material evidence is furnished;
+! A clerical error in the computation of benefits was made; or
+! The evidence clearly shows that an error was made.
+
+ Proposed Rules to Reopen a Case. 47 The rules proposed by the SSA
+
+would restrict the rights of claimants to request that cases be reopened after the
+decision of the ALJ. Claimants would have a much shorter time in which to ask for
+a reopening and would only be able to submit new evidence if their conditions
+changed after the hearing. New evidence relating to a disability that existed at the
+time of the hearing would not be sufficient to reopen a case.
+
+Under the proposed rules, claimants would have 10 days from the date of the
+
+ALJ decision to request that a case be reopened. In addition, the claimant must show
+that one of the following circumstances has occurred:
+
+! An unforeseen and material change in the applicant’s condition
+
+between the end of the hearing and the date of the decision;
+
+! At the hearing the ALJ allowed the applicant to submit evidence
+
+after the decision; or
+
+! The applicant had good cause for missing the deadline to submit
+
+evidence to the ALJ.
+
+For the purposes of this proposed rule, “good cause” is defined as occurring
+
+when one of the following has occurred:
+
+! The actions of the SSA were misleading;
+! The applicant has a physical, mental, educational, or linguistic
+
+limitation that would prevent a reasonable person from compliance;
+or
+
+! Some other unusual or unavoidable circumstance beyond the control
+
+of the applicant prevented compliance.
+
+Claimants unable to get their cases reopened by the ALJ would have to appeal
+
+to the federal courts or reapply for benefits. 
+
+ Proposed Replacement of the Appeals Council 
+with the Decision Review Board 
+
+The proposed rules would replace the existing Appeals Council with the
+
+Decision Review Board and would limit the right of claimants to appeal decisions
+
+47 20 CFR §§ 405.20, 405.373 (proposed in Administrative Review Process for Adjudicating
+Initial Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+ 
+ CRS-20
+
+made by ALJs to this new board, with the goal of bringing finality to the appeals
+process after the decision of the ALJ. The Decision Review Board would retain the
+own-motion authority to review favorable and unfavorable ALJ decisions.
+
+The Judicial Conference of the United States, made up of federal judges, has
+
+expressed concern that eliminating the Appeals Council will increase the number of
+cases being filed in the United States District Courts. Because the federal courts lack
+the specific expertise and experience in handling disability cases that the Appeals
+Council has, the Conference recommends that the Appeals Council, in its current
+form, be retained to serve as a final level of administrative appeal for claimants
+dissatisfied with the decision of an ALJ.48
+
+ Rights of Claimants to Appeal. 
+
+ Current Rules, the Appeals Council. 49 Under the current rules, the final
+
+administrative appeal offered to claimants is a review by the Appeals Council.
+Claimants dissatisfied with the decision of an ALJ or with the dismissal of their case
+by an ALJ have up to 60 days from the date of the decision to request a review of
+their case by the Appeals Council. Unlike the ALJ, the Appeals Council is not
+required to hear all appeals that are filed and can select the cases that it wishes to
+consider.
+
+ Proposed Rules, the Decision Review Board. 50 Under the proposed
+
+rules, the Appeals Council would be replaced by a Decision Review Board, which
+would constitute the final administrative appeal offered to claimants. However,
+unlike the Appeals Council, claimants dissatisfied with the decision of an ALJ would
+not have the right to request a review by the Decision Review Board. Only claimants
+whose cases were dismissed by an ALJ would have the right to request a review.
+Similar to the Appeals Council, the Decision Review Board would set its own docket
+and not be required to rule on all cases presented to it on appeal.
+
+ Own Motion Authority of the SSA. 
+
+ Current Rules, the Appeals Council. 51 Under the current rules, the
+
+Appeals Council has the authority to review cases that have not been appealed by
+claimants. These cases can include decisions of an ALJ that were favorable to
+claimants. However, in such cases, the claimant can be paid interim benefits while
+the Appeals Council considers the case.
+
+48 Commissioner of Social Security’s Proposed Improvements to the Disability
+Determination Process, Joint Hearing Before the Subcommittee on Human Resources and
+the Subcommittee on Social Security, House Committee on Ways and Means , 109th Cong.
+(2005), (statement of the Honorable Judge Howard D. McKibben, Judicial Conference of
+the United States).
+
+49 20 CFR §§ 404.911, 404.968.
+
+50 20 CFR §§ 405.382, 405.405 (proposed in Administrative Review Process for
+Adjudicating Initial Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+51 20 CFR § 404.969.
+
+ 
+ CRS-21
+
+ Proposed Rules, the Decision Review Board. 52 Like the Appeals
+
+Council, the Decision Review Board would have the authority to review ALJ
+decisions, including those decisions that were favorable to claimants. However, no
+provision exists in the proposed rules for interim payments to claimants while their
+cases are being reviewed by the Disability Review Board.
+
+ Evidence Rules and Procedures. 
+
+ Current Rules, the Appeals Council. 53 Under the current rules, the
+
+Appeals Council considers all evidence previously presented to the ALJ and any new
+evidence that relates to the period before the ALJ hearing. Claimants may request
+to appear before the Appeals Council and present an oral argument in support of their
+case.
+
+ Proposed Rules, the Decision Review Board. 54 Because the record is
+
+considered closed after the decision of the ALJ, the Decision Review Board could
+only consider evidence presented to the ALJ and could not consider new evidence.
+Claimants would not be permitted to present an oral argument to the Decision
+Review Board but could request permission to submit a brief written statement.
+
+52 20 CFR §§ 405.410, 405.415 (proposed in Administrative Review Process for
+Adjudicating Initial Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+53 20 CFR § 404.976.
+
+54 20 CFR § 405.425 (proposed in Administrative Review Process for Adjudicating Initial
+Disability Claims, 70 Federal Register 43590, July 27, 2005).
+
+ 
+ 
+
+CRS-22
+
+ Appendix 
+
+ Figure 4. Proposed Disability Determination and Appeals 
+
+ Processes 
+
+ Source: The Social Security Administration, available at
+[http://www.ssa.gov/disability-new-approach/NewApproachFlowchart.pdf].
+
+ Note: A detailed diagram of the existing determination and appeals processes is available on the SSA
+website at [http://www.ssa.gov/disability/disability_process_files/od_process.pdf].
\ No newline at end of file
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@@ -0,0 +1,9 @@
+Social Protection Systems for Forcibly Displaced Populations and Host Communities in Africa's Great Lakes Region
+
+Africa’s Great Lakes Region (GLR) faces some of the world’s most complex and protracted forced displacement situations, driven by recurrent conflict and political instability. Refugees, internally displaced persons, returnees, and host communities coexist amid repeated cycles of displacement and return, placing sustained pressure on national systems and local service delivery. As displacement becomes increasingly protracted and humanitarian financing declines, there is growing urgency to identify development-oriented responses that can deliver predictable, scalable, and sustainable support.
+
+Social Protection Systems for Forcibly Displaced Populations and Host Communities in Africa’s Great Lakes Region examines the role of national social protection systems as a core development response to forced displacement in the GLR, focusing on Burundi, the Democratic Republic of Congo, Rwanda, and Uganda. It assesses how social protection systems currently support forcibly displaced populations and host communities, using a revised Adaptive Social Protection Framework that incorporates displacement-specific vulnerabilities. The framework extends beyond traditional system diagnostics to include policies and legal rights, institutional arrangements and partnerships, programs and delivery systems, data and information systems, and finance.
+
+Drawing on country-level analysis and a regional perspective, the book finds that although GLR countries have made important policy and legal commitments, social protection systems remain at an early stage of adapting to displacement. Coverage of forcibly displaced populations is limited, institutional responsibilities are fragmented, data systems often operate in parallel to humanitarian structures, and financing for inclusion relies heavily on external support. Refugees, in particular, face persistent barriers related to legal status, documentation, employment, freedom of movement, and access to national systems.
+
+Social Protection Systems argues that strengthening national social protection systems—while preserving humanitarian assistance for acute needs—offers a viable pathway to enhance resilience, reduce long-term dependency, and support social cohesion by linking displaced populations and host communities to skills, jobs, and economic opportunities in protracted displacement settings. It proposes sequenced, pragmatic recommendations to help governments and partners transition toward more inclusive, development-led responses, anchored in vulnerability-based approaches, strengthened data systems, and coordinated financing. The findings aim to inform policy dialogue and operational design in the GLR and other regions confronting prolonged forced displacement.
\ No newline at end of file
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@@ -0,0 +1,177 @@
+INSIGHTi 
+
+ 
+
+ The Proposed $600 Bank Reporting 
+Requirement: Frequently Asked Questions 
+
+October 6, 2021 
+A proposal to require financial institutions to report information to the Internal Revenue Service (IRS) on 
+personal and business accounts has garnere d significant publicity and congressional attention. The 
+proposal is commonly referenced as the “new $600 bank reporting requirement.” This Insight addresses a 
+number of frequently asked questions about the proposal. 
+
+ What is the proposal and where did it come from? 
+ The proposal referenced i n media reports was included in t he President’s FY2022 budget request and is 
+described as being part of a “comprehensive” financial account information reporting regime. The 
+ General Explanations of the Administration’s Fiscal Year 2022 Revenue Proposals , w hich accompanies 
+the President’s budget request, states that 
+
+Financial institutions would report data on financial accounts in an information return. The annual 
+return will report gross inflows and outflows with a breakdown for physical cash, transactions with 
+a foreign account, and transfers to and from another account with the same owner. This requirement 
+would apply to all business and personal accounts from financial institutions, including bank, loan, 
+and investment accounts, with the exception of accounts below a low de minimis gross flow 
+threshold of $600 or fair market value of $600. 
+
+The General Explanations also mention similar reporting requirements for cryptocurrency and state that 
+ payment settlement entities would be covered by the new regime. Additionally, crypto asset exchanges 
+and custodians, as well as crypto transactions exceeding $10,000, would require information reporting. 
+
+ Is the proposal included in legislation? 
+ The new $600 bank reporting requirement proposal is not currently a legislative proposal. Some have 
+suggested that it may be considered as Congress develops modifications to either the reconciliation bill 
+ (H.R. 5376) , known as the Build Back Better Act, or the infrastructure bill (H.R. 3684, as amended and 
+passed by the Senate on August 10, 2021). 
+
+ Congressional Research Service 
+
+https://crsreports.congress.gov 
+
+IN11772 
+
+ CRS INSIGHT 
+ Prepared for Members and 
+
+ Committees of Congress 
+
+ 
+
+ 
+
+ 
+
+ 
+ Congressional Research Service 
+
+2 
+
+The Senate-passed version of H.R. 3684 includes a separate information reporting requirement that would 
+require a party facilitating the transfer of cryptocurrency to file an information return as a broker with the 
+IRS. The Senate-passed version of H.R. 3684 would also require a business that receives cryptocurrency 
+worth more than $10,000 in a single transaction to report the transaction to the IRS. The Joint Committee 
+on Taxation (JCT) estimates that these information reporting requirements would raise $28 billion over 10 
+years. For more information on this proposal, see CRS In Focus IF1 1910, Cryptocurrency Transfers and 
+Data Collection , by Mark P. Keightley and Andrew P. Scott. 
+
+ What is the purpose of information reporting? 
+ There are two general purposes of information reporting. The first is to increase tax compliance and to 
+reduce money laundering and illicit financial activity. The second is to provide information to taxpayers 
+to allow them to accurately calculate their tax liability. When an information return is filed, a copy of the 
+return is sent to the IRS and a copy is sent to the taxpayer. This allows the IRS to double-check the 
+information reported by a taxpayer. Additionally, the IRS can use the information to flag returns for audit. 
+At the same time, the copy sent to taxpayers provides them with information that they may need when 
+completing their tax return. Taxpayers may also be more likely to accurately report their income if they 
+know the IRS has this information. Information returns typically must be sent to the IRS and taxpayer 
+early in the calendar year. 
+
+ What are the current information reporting 
+requirements? 
+ A significant number of transactions are currently subject to information reporting requirements. The 
+IRS’ s Guide to Information Returns identifies transactions in the following categories: general, education, 
+health insurance, transfers of stock, and retirement. Financial institutions are currently required to file 
+information returns for any account for which interest payments or dividends are $10 or more throughout 
+the year. They are also required to report the amount of mortgage interest paid, student loan interest paid, 
+amount of canceled debt, distributions from certain retirement accounts, and certain transactions in which 
+they serve as a payment settlement entity, among others. 
+
+Taxpayers are legally required to pay the appropriate tax regardless of whether they receive an 
+information return. For example, an individual who receives $9 of interest on a savings account is 
+required to pay tax on that income, even if an information return is not received. 
+
+ Is the proposal a new tax? 
+ The proposed bank reporting requirement would not be a new tax. Information reporting, as the name 
+suggests, provides more information to both the IRS and taxpayers. If, however, the additional 
+information results in taxpayers making additional payments in compliance with existing tax laws, 
+taxpayers may pay more in taxes. 
+
+ What are the trade-offs involved with information 
+reporting? 
+ Information reporting raises a number of general policy considerations. One concern is the appropriate 
+balance between government data collection and the rights of individuals. Information reporting may 
+
+ 
+
+ 
+ Congressional Research Service 
+
+3 
+
+assist the IRS in fulfilling its statutory obligation to administer the tax code, but it also subjects 
+individuals and businesses to greater government scrutiny. Another consideration is that increased 
+information reporting would place an administrative burden on financial institutions required to make 
+reports. The magnitude of such a burden is not necessarily clear given that financial institutions are 
+already required to report certain information. At the same time, increased information reporting may 
+assist individuals in completing their tax returns and more easily complying with the law. With regard to 
+the proposed bank reporting requirement, it is not clear how knowing one’s financial flows throughout the 
+year would help in determining taxable income . 
+
+ How could increased information reporting reduce the 
+tax gap? 
+ The proposed $600 bank reporting requirement would likely decrease the tax gap by increasing tax 
+collections. The tax gap is the difference between the aggregate amount of taxes legally owed and the 
+aggregate amount of taxes collected. The latest IRS estimates suggest that the gross tax gap costs the 
+federal government $441 billion in lost tax revenue per year. Late payments and enforcement actions 
+reduce this gap to $381 billion. I n an April 13, 2021, Senate Committee on Finance hearing, IRS 
+Commissioner Charles P. Rettig raised the possibility that the tax gap may now be closer to $1 trillion per 
+year once the rise in popularity of cryptocurrency, foreign-source income, taxable illegal income, and 
+more recent estimates regarding high-income taxpayers are accounted for . Some have questioned the 
+accuracy of this estimate. Still, the IRS’s tax gap estimates clearly demonstrate that income subject to 
+little or no information reporting is more likely to be underreported for tax purposes than income subject 
+to more information reporting. About $245 billion (56%) of the gross tax gap is attributable to 
+underreporting of income on the individual side. Income that is subject to little or no information 
+reporting accounts for $109 billion (55%) of the $245 billion shortfall. Income subject to substantial 
+reporting and withholding accounts for just $9 billion (1%) of the shortfall. 
+
+ 
+
+ 
+
+ Author Information 
+
+ 
+Mark P. Keightley 
+
+ 
+
+Specialist in Economics 
+ 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff 
+to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of 
+Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of 
+information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role. 
+CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United 
+States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However,
+
+ 
+
+ 
+ Congressional Research Service 
+
+4 
+
+as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the 
+permission of the copyright holder if you wish to copy or otherwise use copyrighted material. 
+
+ 
+
+IN11772 · VERSION 1 · NEW
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+Updated July 14, 2022
+
+ Guyana: An Overview 
+
+Located on the northern coast of South America between 
+
+multiple legal challenges by supporters of the previous 
+
+Suriname and Venezuela, English-speaking Guyana has 
+
+Granger government. 
+
+characteristics similar to other Caribbean nations because of 
+a common British colonial heritage (Guyana became 
+
+After his inauguration, President Ali appointed retired 
+
+independent in 1966). The country participates in Caribbean 
+
+military leader Mark Phillips as prime minister and former 
+
+regional organizations, and its capital, Georgetown, serves 
+
+President Bharrat Jagdeo (1999-2011) as vice president. 
+
+as headquarters for the Caribbean Community 
+
+Some observers contend that Jagdeo, who was 
+
+(CARICOM), a regional integration organization. Once one 
+
+constitutionally prohibited from seeking a third term, plays 
+
+of the poorest countries in the hemisphere, Guyana’s 
+
+a key role in policy decisions. Guyana’s next national 
+
+development prospects have shifted significantly since the 
+
+elections are not due until 2025, but local elections are 
+
+discovery of large offshore oil deposits in 2015. 
+
+expected to be held in late 2022 and could serve as a 
+referendum on the ruling PPP/C’s performance. 
+
+ Figure 1. Map of Guyana 
+
+ Guyana at a Glance 
+
+ Population : 789,000 (2021 est., IMF) 
+ Ethnic Groups : Indo-Guyanese, or those of East Indian 
+heritage, almost 40%; Afro-Guyanese, almost 30%; mixed, 
+20%; Amerindian, almost 11% (2012 est., CIA) 
+ Area: 83,000 square miles, about the size of Idaho 
+ GDP: $7.6 bil ion (2021, current prices, IMF) 
+ Real GDP Growth: 5.4% (2019); 43.5% (2020); 19.9% (2021 
+est.); 47.2% (2022 forecast) (constant prices, IMF) 
+ Per Capita GDP : $9,644 (2021 est., current prices, IMF) 
+ Sources: International Monetary Fund (IMF), World Economic 
+Outlook Database, April 2022; and Central Intel igence Agency 
+(CIA), World Factbook. 
+
+ 
+
+Political affiliations in Guyana often fall along ethnic lines. 
+The ruling PPP/C, which traditionally has been supported 
+by Indo-Guyanese, governed Guyana from 1992 to 2015. 
+
+ 
+
+The largest party in the opposition APNU coalition is the 
+
+ Source: Congressional Research Service. 
+
+People’s National Congress Reform (PNCR), which 
+dominated the political system from independence until 
+
+ Political and Economic Environment 
+
+1992 and draws support from an Afro-Guyanese base. The 
+
+Guyana has a hybrid republican/parliamentary form of 
+
+other main opposition party, AFC, identifies as a multiracial 
+
+government, with a 65-member unicameral National 
+
+party. In the aftermath of the 2020 election crisis, some 
+
+Assembly. The presidential candidate of the party or 
+
+experts expressed concern about an increase in ethnic 
+
+coalition receiving the most votes becomes president, and 
+
+tension and called for the adoption of a more ethnically 
+
+the president appoints the prime minister and Cabinet. 
+
+inclusive approach toward governing. 
+
+Current President Dr. Mohamed Irfaan Ali of the People’s 
+
+ COVID-19 in Guyana 
+
+Progressive Party/Civic (PPP/C) won the country’s March 
+
+Since the Coronavirus Disease 2019 (COVID-19) pandemic 
+
+2020 elections, defeating incumbent President David 
+
+began, Guyana has reported 1,262 deaths from the virus, 
+
+Granger, who led a coalition consisting of A Partnership for 
+
+with a mortality rate of 160 per 100,000 people as of July 
+
+National Unity (APNU) and the Alliance for Change 
+
+12, 2022, according to Johns Hopkins University. The 
+
+(AFC). In the National Assembly, Ali’s PPP/C took a 
+
+country also reported a vaccination rate of almost 47%, 
+
+majority of 33 seats, the APNU/AFC coalition won 31 
+
+with vaccine hesitancy a challenge; in June 2022, the 
+
+seats, and a smaller party won the remaining seat. Marred 
+
+government began rolling out vaccines for children aged 5 
+
+by allegations of fraud, final elections results were delayed 
+
+to 11. Guyana has benefited from vaccine donations 
+
+until August 2020 after a recount by a CARICOM team and 
+
+through the COVID-19 Vaccines Global Access (COVAX) 
+Facility, a mechanism developed by global health 
+
+https://crsreports.congress.gov 
+
+ 
+ Guyana: An Overview 
+
+organizations to facilitate equitable distribution of vaccines. 
+
+In June 2022, President Biden and Vice President Harris 
+
+It also has received vaccine donations bilaterally outside of 
+
+met with President Ali and other Caribbean leaders at the 
+
+COVAX, including from the United States (see below). 
+
+Ninth Summit of the Americas in Los Angeles, CA. 
+Discussions centered on the impact of climate change; food 
+
+ Oil Changes Guyana’s Economic Outlook 
+
+and energy insecurity; lack of access to financing; and 
+
+Guyana’s economy traditionally was based on agriculture 
+
+security cooperation and engagement, including on small 
+
+(rice and sugar) and mining (gold and bauxite), but the 
+
+arms trafficking. At the summit, Vice President Harris 
+
+discovery of significant amounts of offshore oil, bolstered 
+
+announced the U.S.-Caribbean Partnership to Address the 
+
+the country’s development prospects. The U.S. Geological 
+
+Climate Crisis (PACC 2030), a new initiative aimed at 
+
+Survey estimates reserves of 13.6 billion barrels of oil and 
+
+facilitating renewable energy infrastructure development 
+
+32 trillion cubic feet of gas. ExxonMobil leads a consortium 
+
+and bolstering resilience to climate-based natural disasters. 
+
+that includes Hess and China National Offshore Oil 
+
+ Trade. As Guyana has become an oil-producing nation, 
+
+Corporation and has been involved in oil and gas 
+
+trade with the United States has increased significantly. The 
+
+exploration in Guyana since 2008. Since 2015, the 
+
+United States ran a trade deficit of $1.25 billon with 
+
+consortium has identified numerous commercially viable 
+
+Guyana in 2021, with U.S. exports valued at $991 million, 
+
+discoveries in the Stabroek Block, about 120 miles 
+
+up 51% from 2020, and U.S. imports valued at $2.2 billion, 
+
+offshore. Production began in December 2019, reached 
+
+up 200% from 2020 (oil and gas accounted for almost 
+
+120,000 barrels of oil per day (b/d) in 2021, is expected to 
+
+93%). Since 1988, Guyana has been a beneficiary of the 
+
+reach 340,000 b/d in 2022, and could reach 1.2 million b/d 
+
+Caribbean Basin Economic Recovery Act (P.L. 98-67, as 
+
+by 2027, according to ExxonMobil. ExxonMobil is also the 
+
+amended, with no expiration), a preferential trade program 
+
+operator in two other offshore oil blocks in Guyana, and the 
+
+for Caribbean imports. Since 2000, it has been a beneficiary 
+
+government plans to auction new blocks for offshore oil 
+
+of the Caribbean Basin Trade Partnership Act (Title II of 
+
+exploration later in 2022. 
+
+P.L. 106-200, extended through September 2030), which 
+
+Guyana’s oil production has enabled the country to 
+
+provides enhanced tariff preferences for certain imports, 
+
+withstand much of the economic fallout from the pandemic. 
+
+including goods made with U.S. yarns, fabrics, and threads. 
+
+In 2020, despite a global recession, Guyana’s economy 
+grew almost 44%, according to the International Monetary 
+
+ U.S. Foreign Aid. The United States provided $7.8 million 
+
+Fund (IMF). In 2021, it grew almost 20%, and the forecast 
+
+in assistance to Guyana in FY2020 from all U.S. agencies 
+
+for 2022 is 47% growth. In 2019, Guyana’s National 
+
+(https://foreignassistance.gov/cd/guyana/, latest full-year 
+
+Assembly approved legislation establishing the Natural 
+
+available). The top categories included support for health, 
+
+Resource Fund (NRF), a sovereign wealth fund for 
+
+education, and environmental programs; strengthening 
+
+managing the country’s oil wealth. In December 2021, the 
+
+government institutions and civil society; military education 
+
+government approved legislation amending the NRF’s 
+
+and training; and humanitarian assistance for Venezuelan 
+
+regulatory framework, maintaining the action would ensure 
+
+migrants (estimated to number 24,500 as of May 2022). 
+
+greater transparency and accountability. Guyana’s 2022 
+budget is the first benefitting from NRF financing, which 
+
+Among U.S. aid programs, Guyana received assistance 
+
+the government maintains will support infrastructure 
+
+between FY2004 and FY2020 to combat HIV/AIDS 
+
+investments, including in energy and transportation, and 
+
+through the President’s Emergency Plan for AIDS Relief 
+
+social expenditures in health and education. 
+
+program. Since 2009, it has benefited from aid provided 
+through the Caribbean Basin Security Initiative (CBSI), a 
+
+ U.S.-Guyana Relations 
+
+U.S. regional aid program to combat the drug trade and 
+
+U.S. relations with Guyana improved in the early 1990s 
+
+improve citizen security. CBSI support has provided patrol 
+
+when the government moved away from one-party 
+
+boats, training, and equipment for police and customs units 
+
+domination of the political system and embraced a market 
+
+and assistance for youth programs and juvenile justice 
+
+economy and free and fair elections. Today, according to 
+
+reform. Before the suspension of a Peace Corps program 
+
+the State Department, U.S. policy toward Guyana seeks to 
+
+due to COVID-19, Guyana hosted over 60 volunteers 
+
+support robust and sustainable democratic institutions, an 
+
+working on education, health, and environmental projects. 
+
+empowered civil society, economic growth and 
+development, and stability and security. 
+
+The United States has provided assistance to help Guyana 
+respond to the COVID-19 pandemic, including vaccination 
+
+In the aftermath of the March 2020 elections, U.S. 
+
+tents, freezers for vaccine storage, personal protective 
+
+Ambassador Sarah-Ann Lynch and the heads of mission 
+
+equipment, and support to combat vaccine hesitancy. To 
+
+from Canada, the United Kingdom (UK), and the European 
+
+date, the United States has donated almost 302,000 vaccine 
+
+Union (EU) played a major role in supporting a recount and 
+
+doses (about half through COVAX and half bilaterally), 
+
+pressing for a resolution. In July 2020, the State 
+
+including a recent shipment of almost 13,000 vaccine doses 
+
+Department imposed visa restrictions on several unnamed 
+
+in July 2022. 
+
+Guyanese individuals for undermining democracy. Upon 
+the resolution of the crisis in August 2020, the U.S., UK, 
+
+For additional information, see CRS In Focus IF10789, 
+
+Canadian, and EU ambassadors issued a joint statement that 
+
+ Caribbean Basin Security Initiative . 
+
+congratulated President Ali, thanked President Granger for 
+accepting the results, and looked forward to seeing the new 
+
+ Mark P. Sullivan , Specialist in Latin American Affairs 
+
+government “reach across political divisions to unite 
+
+ Joshua Klein , Presidential Management Fellow 
+
+Guyanese of all ethnicities, races, and regions.” 
+
+ IF11381 
+
+https://crsreports.congress.gov 
+
+ 
+ Guyana: An Overview 
+
+ 
+
+ 
+
+ Disclaimer 
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to 
+congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. 
+Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has 
+been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the 
+United States Government, are not subject to copyright protection in the United States. Any CRS Report may be 
+reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include 
+copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you 
+wish to copy or otherwise use copyrighted material. 
+
+ 
+
+ https://crsreports.congress.gov | IF11381 · VERSION 14 · UPDATED
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+The Financial Crimes Enforcement Network 
+
+September 27, 2022 
+
+ (FinCEN): Anti-Money Laundering Act of 2020 
+
+ Liana W. Rosen 
+
+ Implementation and Beyond 
+
+Specialist in International 
+Crime and Narcotics 
+
+On January 1, 2021, Congress passed the Anti-Money Laundering Act of 2020 (AMLA) 
+
+ 
+
+as Division F of the William M. (Mac) Thornberry National Defense Authorization Act 
+
+ Rena S. Miller 
+
+(NDAA) for FY2021 (P.L. 116-283). AMLA amends and builds upon the existing anti-
+
+Specialist in Financial 
+
+money laundering (AML) statutory framework, originally established under the Bank 
+
+Economics 
+
+Secrecy Act in 1970 (BSA; P.L. 91-508). AMLA also contains the Corporate 
+
+ 
+
+Transparency Act (CTA; Title LXIV of Division F of the FY2021 NDAA), which for the 
+first time imposes a federal requirement for identifying beneficial owners of certain 
+
+ 
+
+legal entities. If fully implemented by the executive branch, AMLA may represent one of the most comprehensive 
+efforts in recent decades to modernize the U.S. government’s regulatory architecture for AML, combat the 
+financing of terrorism (CFT), and detect other financial crime activity. 
+
+Among its most significant objectives, AMLA contains provisions to 
+
+ establish new federal-level beneficial ownership disclosure and transparency requirements; 
+ expand the BSA’s purpose and mandate a review of the AML/CFT regulatory framework; 
+ promote public-private partnership and engagement opportunities on AML/CFT matters; 
+ introduce new staffing options and programs to enhance AML/CFT expertise; 
+ promote international cooperation on financial crime matters, while protecting financial 
+
+intelligence from misuse; 
+
+ strengthen enforcement tools to deter money laundering and other forms of financial crime; 
+ invigorate BSA whistleblower provisions; and 
+ expand the BSA’s regulatory scope to include businesses that provide services involving “value 
+
+that substitutes for currency.” 
+
+The Financial Crimes Enforcement Network (FinCEN) is the primary federal agency responsible for 
+implementing many of AMLA’s provisions. A bureau of the U.S. Department of the Treasury, FinCEN plays a 
+leading role in protecting the U.S. financial system from illicit financial threats through its mission to collect and 
+maintain a repository of financial intelligence from financial institutions and then analyze and disseminate this 
+information to law enforcement agencies in support of investigations pursuing perpetrators of criminal activity. As 
+one of the primary regulators and administrators of the BSA, FinCEN also has a leading role to play in AMLA’s 
+implementation. AMLA has tasked the Secretary of the Treasury, often in practice acting through the Director of 
+FinCEN, to promulgate multiple federal rulemakings to strengthen and improve the AML/CFT regulatory regime, 
+issue multiple reports, and take other programmatic and personnel actions. 
+
+Some Members of Congress and other policy observers and stakeholders are closely monitoring FinCEN’s 
+progress in implementing AMLA, including the CTA. AMLA specifies deadlines for many of its implementation 
+tasks—some of which, including the CTA’s directive for FinCEN to establish a federal database for identifying 
+the beneficial owners of certain corporate entities, are substantively and politically challenging to achieve. In 
+April 2022 testimony to the House Financial Services Committee, FinCEN’s Acting Director emphasized the 
+strategic importance of AMLA’s provisions while also acknowledging that the agency had fallen behind in 
+meeting AMLA’s implementation deadlines, due in part to a lack of resources. Addressing deficiencies in the U.S. 
+AML regime, particularly with respect to beneficial ownership transparency, is a strategic objective of the Biden 
+Administration’s December 2021 U.S. Strategy on Countering Corruption . 
+
+Congressional Research Service 
+
+ 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+According to FinCEN’s April 2022 testimony, among the AMLA provisions that have not been implemented are 
+the requirements to establish and staff an Office of Domestic Liaison, hire at least six foreign financial 
+intelligence unit (FIU) liaisons, and appoint BSA innovation officers. Implementation of other AMLA 
+provisions—including those related to beneficial ownership information collection, modernization of the 
+AML/CFT regulatory framework that prioritizes innovation, an updated BSA whistleblower program, the 
+development of updated BSA training for all federal bank examiners in the United States, and the establishment of 
+more effective BSA data feedback loops between FinCEN, financial institutions, and law enforcement—remain 
+works in progress, pending the issuance of new regulations, personnel and financial resources, and time to 
+establish new programs. 
+
+ 
+
+Congressional Research Service 
+
+ 
+ link to page 5 link to page 6 link to page 6 link to page 7 link to page 8 link to page 10 link to page 12 link to page 12 link to page 14 link to page 14 link to page 15 link to page 15 link to page 16 link to page 17 link to page 18 link to page 18 link to page 19 link to page 19 link to page 20 link to page 22 link to page 22 link to page 23 link to page 25 link to page 26 link to page 27 link to page 27 FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ Contents 
+
+ Introduction ..................................................................................................................................... 1 
+ Background ..................................................................................................................................... 2 
+
+ FinCEN: An Overview .............................................................................................................. 2 
+ BSA “Modernization” and FinCEN “Transformation” ............................................................. 3 
+ Corporate Transparency, Beneficial Ownership Disclosure, and Illicit Financial Flows .......... 4 
+
+ AMLA: Key Provisions ................................................................................................................... 6 
+ AMLA Implementation: Rulemakings ............................................................................................ 8 
+
+ The CTA and Beneficial Ownership Disclosure ....................................................................... 8 
+ Status of Other AMLA Rulemaking Requirements ................................................................. 10 
+
+ Rulemaking on AML/CFT Priorities ................................................................................ 10 
+ AML Regulations for Dealers in Antiquities ..................................................................... 11 
+Pilot SAR Sharing Program ............................................................................................... 11 
+ No-Action Letter Process .................................................................................................. 12 
+ Other Prospective Rulemakings ........................................................................................ 13 
+
+ AMLA Implementation: Reporting Requirements ........................................................................ 14 
+
+ CTA Reporting Requirements ................................................................................................. 14 
+ Threat Pattern and Trend Information ..................................................................................... 15 
+Review of Regulations and Guidance ..................................................................................... 15 
+ Other Treasury Department Reporting Requirements ............................................................. 16 
+
+ Selected Issues for Congress ......................................................................................................... 18 
+
+ Challenges in Meeting AMLA Implementation Deadlines ..................................................... 18 
+ FinCEN Funding for AMLA Implementation ......................................................................... 19 
+ Status of Beneficial Ownership Rulemaking and Registry ..................................................... 21 
+ Law Enforcement Implications for AMLA Implementation ................................................... 22 
+ Selected Legislation in the 117th Congress .............................................................................. 23 
+
+ 
+
+ Contacts 
+ Author Information ........................................................................................................................ 23 
+ 
+
+Congressional Research Service 
+
+ 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ Introduction 
+ On January 1, 2021, Congress passed the Anti-Money Laundering Act of 2020 (AMLA), which 
+encompassed the most sweeping reforms to U.S. anti-money laundering (AML) policy in recent 
+decades. Contained within the William M. (Mac) Thornberry National Defense Authorization Act 
+(NDAA) for FY2021 (Division F, P.L. 116-283), AMLA spans 59 provisions, including a distinct 
+title known as the Corporate Transparency Act (CTA; Title LXIV).1 These provisions aim to 
+significantly update and expand aspects of the existing policy framework for anti-money 
+laundering and combating the financing of terrorism (AML/CFT), originally established under the 
+Bank Secrecy Act (BSA) in 1970.2 
+
+The primary federal agency responsible for implementing the majority of AMLA’s provisions is 
+the Financial Crimes Enforcement Network (FinCEN). A bureau of the Department of the 
+Treasury, FinCEN is also known as the U.S. government’s financial intelligence unit (FIU).3 
+FinCEN has described AMLA implementation as a “top priority” and has fulfilled several AMLA 
+reporting requirements and initiated the rulemaking process for several AMLA requirements, 
+including beneficial ownership disclosure requirements pursuant to the CTA.4 According to 
+FinCEN, AMLA, including the CTA, require approximately 40 rulemakings or other 
+congressional mandates, such as periodic reporting on implementation efforts, assessments, and 
+findings.5 
+
+Some Members of Congress and other policy observers and stakeholders are closely monitoring 
+FinCEN’s progress in implementing AMLA, including the CTA. To this end, AMLA requires the 
+FinCEN Director to testify before Congress on an annual basis for five years, beginning in 2022, 
+on AMLA implementation (§6403). In the first of such testimonies on April 28, 2022, FinCEN 
+acknowledged to the House Financial Services Committee that it had fallen behind in meeting 
+AMLA’s implementation deadlines due in part to a lack of resources.6 At the hearing, some 
+Members of Congress also raised substantive concerns regarding FinCEN’s rulemaking proposals 
+for CTA implementation, while others have expressed support.7 
+
+ 
+1 Apart from the Anti-Money Laundering Act of 2020 (AMLA), the FY2021 NDAA contained additional provisions on 
+financial services matters in Title XCVII of Division H (§§9701-9724), which included subtitles on the Kleptocracy 
+Asset Recovery Rewards Act (Subtitle A) and the Combating Russian Money Laundering Act (Subtitle B). 
+
+2 The Currency and Foreign Transactions Reporting Act of 1970, commonly referred to as the Bank Secrecy Act 
+(BSA), is the foundational statutory basis for the U.S. regime for anti-money laundering. Several acts have amended 
+the BSA, including the Money Laundering Control Act of 1986 (Title I, Subtitle H of P.L. 99-570), the Annunzio-
+Wylie Anti-Money Laundering Act (Title XV of P.L. 102-550), the Money Laundering Suppression Act of 1994 (Title 
+IV of P.L. 103-325), the Money Laundering and Financial Crimes Strategy Act of 1998 (P.L. 104-310), the 
+International Money Laundering Abatement and Anti-Terrorist Financing Act of 2001 (Title III of P.L. 107-56), and 
+the Anti-Money Laundering Act of 2020 (Division F of P.L. 116-283). Collectively, the BSA is codified at 12 U.S.C. 
+§§1829b, 1951-1960 and 31 U.S.C. §§5311-5314, 5316-5336. Implementing regulations are located at 31 C.F.R. ch. X. 
+
+3 U.S. Department of the Treasury, Bureaus , https://home.treasury.gov/about/bureaus. 
+4 Financial Crimes Enforcement Network (FinCEN), Message from the FinCEN Director: 180-Day Update on AML 
+Act Implementation , June 30, 2021. See also FinCEN, “The Anti-Money Laundering Act of 2020,” 
+https://www.FinCEN.gov/anti-money-laundering-act-2020. 
+
+5 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 4. 
+
+6 CQ transcripts, House Financial Services Committee Holds Hearing on Financial Crimes Enforcement Network , 
+April 28, 2022. 
+
+7 Ibid. 
+
+Congressional Research Service 
+
+ 
+
+1 
+
+ 
+ link to page 22 link to page 22 FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+After providing a brief overview on FinCEN and the underlying policy rationales that contributed 
+to AMLA’s enactment, this report focuses on identifying AMLA’s key provisions—and the status 
+of AMLA-related rulemaking and reporting requirements to be implemented by the Treasury 
+Department, chiefly FinCEN. The report concludes with a discussion of selected issues for 
+congressional oversight and further legislative action, including challenges associated with 
+meeting AMLA-specified deadlines (several implementation deadlines are past due), funding 
+(AMLA authorized but did not appropriate funding for its implementation), and the establishment 
+of the beneficial ownership database required by the CTA. 
+
+Several bills in the 117th Congress seek further changes to the BSA and the U.S. government’s 
+AML/CFT policy framework, including the House-passed National Defense Authorization Act 
+for Fiscal Year 2023 (H.R. 7900; FY2023 NDAA), which includes multiple provisions on 
+financial services matters (Title LIV, §§5401-5475). See section on “Selected Issues for 
+Congress” for further discussion. 
+
+ Background 
+ FinCEN has described AMLA as a “landmark piece of legislation” that provides FinCEN a 
+“leading role” in strengthening the U.S. AML/CFT architecture.8 This section provides an 
+overview of FinCEN and provides context for several primary policy rationales that contributed 
+to AMLA’s enactment—a desire for BSA “modernization” and FinCEN “transformation” as well 
+as domestic and international pressure to address perceived AML/CFT gaps in corporate 
+transparency. 
+
+ FinCEN: An Overview 
+ FinCEN plays a key role in the Secretary of the Treasury’s overall stewardship of U.S. economic 
+and financial systems and related policy, particularly with respect to AML/CFT policy. FinCEN’s 
+mission is “to safeguard the financial system from illicit use, combat money laundering and its 
+related crimes including terrorism, and promote national security through the strategic use of 
+financial authorities and the collection, analysis, and dissemination of financial intelligence.”9 For 
+FY2022, FinCEN’s budget totaled approximately $172.7 million.10 
+
+FinCEN was established in 1990 to exercise AML regulatory functions under the BSA. Its 
+responsibilities include developing regulations and related policies that require banks and other 
+financial institutions to safeguard the U.S. financial system from illicit activity. In addition to its 
+responsibilities for BSA oversight and rulemakings, FinCEN engages with the private sector, 
+federal regulators, law enforcement, and the international community on AML/CFT matters. As 
+the U.S. FIU, FinCEN also engages with counterparts around the world through the Egmont 
+
+ 
+8 FinCEN, Prepared Remarks of FinCEN Deputy Director AnnaLou Tirol, Delivered Virtually at AML Intelligence’s 
+Women in FinCrime Event , March 3, 2022. 
+
+9 FinCEN, Mission , https://www.fincen.gov/about/mission. 
+10 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 3, https://home.treasury.gov/system/files/266/13.-FinCEN-FY-2023-
+CJ.pdf. FinCEN’s FY2022 budget total includes appropriated resources (approximately $127.0 million) and other 
+available resources, including reimbursable resources, recoveries from prior years, unobligated balances from prior 
+years, and resources transfers in and out via the Treasury Executive Office for Asset Forfeiture (approximately $45.7 
+million). 
+
+Congressional Research Service 
+
+ 
+
+2 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+Group to share information and expertise in support of U.S. and foreign financial crime 
+investigations.11 
+
+As part of its mission, FinCEN collects and maintains a central repository of financial intelligence 
+(e.g., financial transaction data, including suspicious activity reports and currency transaction 
+reports) from financial institutions. In FY2022, FinCEN received approximately 23.5 million 
+BSA-mandated financial transaction reports, including approximately 3.6 million suspicious 
+activity reports (SARs).12 For FY2023, FinCEN projects that it will receive approximately 24 
+million BSA report filings, including approximately 3.7 million SARs.13 FinCEN analyzes and 
+disseminates such information to law enforcement agencies in support of investigations pursuing 
+perpetrators of white collar crime; drug trafficking and other transnational criminal activity; and 
+terrorism and other matters of national security concern.14 The “follow the money” approach to 
+federal criminal investigations, built in part on the basis of financial intelligence collected by 
+FinCEN and accessed by various law enforcement agencies, has reportedly contributed to a 
+substantial number of money laundering-related convictions.15 
+
+The FinCEN Director reports to the Under Secretary of the Treasury for Terrorism and Financial 
+Intelligence (TFI) and the Secretary-appointed position is not subject to Senate confirmation.16 As 
+of mid-September 2022, Secretary Janet Yellen had not appointed a FinCEN Director. The current 
+FinCEN Acting Director is Himamauli “Him” Das, whose appointment was announced on August 
+3, 2021.17 
+
+ BSA “Modernization” and FinCEN “Transformation” 
+ AMLA is the culmination of multiple statutory proposals introduced in the 116th Congress 
+intended to comprehensively strengthen and modernize FinCEN’s AML/CFT capabilities.18 As 
+
+ 
+11 Egmont Group, About the Egmont Group , https://egmontgroup.org/about/. 
+12 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 13. 
+
+13 Ibid. 
+14 Although FinCEN has the authority to issue civil money penalties, it does not have criminal investigative or arrest 
+authorities. Instead, FinCEN uses its data analysis capabilities to support investigations and prosecutions of financial 
+crimes, and refers possible cases to law enforcement authorities when warranted. It also submits requests for 
+information to financial institutions from law enforcement agencies conducting criminal investigations. One example of 
+FinCEN’s analytical function is its Financial Institution Advisory Program, through which FinCEN issues public and 
+nonpublic advisories on illicit finance threats. Section 6206 of the AMLA expands upon this analytical function to 
+require FinCEN to issue periodic financial threat analyses. 
+
+15 During the 2010-2014 timeframe, the Financial Action Task Force (FATF) reported that the United States averaged 
+approximately 1,200 money laundering-related convictions each year. See Financial Action Task Force, United States: 
+Mutual Evaluation Report, Anti-Money Laundering and Counter-Terrorist Financing Measures , December 2016, pp. 
+64-65. 
+
+16 U.S. Department of the Treasury, Terrorism and Financial Intelligence , https://home.treasury.gov/about/offices/
+terrorism-and-financial-intelligence. 
+
+17 FinCEN, FinCEN Announces New Acting Director , August 3, 2021. 
+18 As described in the joint explanatory statement published in the conference report accompanying the FY2021 
+NDAA, the enacted AMLA provisions drew from several bills in the 116th Congress, including H.R. 2513, the 
+Corporate Transparency Act of 2019, which passed the House and was included in the House-passed version of the 
+FY2021 NDAA (Division F, H.R. 6395); H.R. 2514, the Coordinating Oversight, Upgrading and Innovating 
+Technology, and Examiner Reform Act of 2019 (the COUNTER Act of 2019), which passed the House and was 
+included in the House-passed version of the FY2021 NDAA (Division G, H.R. 6395); H.R. 7592, the Stopping 
+Trafficking, Illicit Flows, Laundering, and Exploitation Act of 2020 (the STIFLE Act of 2020), which passed the 
+House and was included in the House-passed version of the FY2021 NDAA (Division L, H.R. 6395); S. 2563, the 
+
+Congressional Research Service 
+
+ 
+
+3 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+noted in the joint explanatory statement published in the conference report accompanying the 
+FY2021 NDAA (H.Rept. 116-617), 
+
+The conferees note that the current Anti-Money Laundering/Countering the Financing of 
+Terrorism (AML/CFT) regulatory framework is an amalgamation of statutes and 
+regulations that are grounded in the Bank Secrecy Act (BSA) (21 U.S.C. 5311 et seq.), 
+which the Congress enacted in 1970. This decades-old regime, which has not seen 
+comprehensive reform and modernization since its inception, is generally built on 
+individual reporting mechanisms (i.e., currency transaction reports (CTRs) and suspicious 
+activity reports (SARs)) and contemplates aging, decades-old technology, rather than the 
+current, sophisticated AML compliance systems now managed by most financial 
+institutions. The provisions ... [in AMLA] comprehensively update the BSA for the first 
+time in decades and provide for the establishment of a coherent set of risk-based 
+priorities.19 
+
+In line with the mandates enacted by AMLA, FinCEN is integral to what Acting Director Him 
+Das describes as “transformation of the [AML/CFT] regulatory regime writ large .”20 
+
+Until recently, the overarching legal foundation of our regime was an artifact of the 
+moment it was most recently updated—in the wake of 9/11—and like most 21-year-old 
+things, it has not entirely kept up with the times. Just as earlier incarnations of the Bank 
+Secrecy Act were laser-focused on countering drug-related financial flows, the updates in 
+the USA PATRIOT Act really emphasized disrupting the money flows of groups like al 
+Qaida. It never anticipated the challenges of the 2020s: digital assets, strategic corruption, 
+an explosion of kleptocrats hiding their wealth in American shell companies, or artificial 
+intelligence [AI] that could help us recognize these crimes and others. 
+
+And although there has been important work through regulation, rulemaking, and guidance 
+to keep pace with evolving risks, our legal foundation was in many respects built, as the 
+aphorism goes, “to fight the last war.” Or at least that was the case until 2021, when 
+Congress passed the Anti-Money Laundering Act of 2020, or the AML Act. 
+
+The AML Act ... touched off a new, post-post-9/11 era for anti-money laundering, giving 
+FinCEN the authority to, quote, “streamline, modernize, and update the AML/CFT regime 
+of the United States,” and that, indeed, is what we are doing. 
+
+... FinCEN is helping transform our nation’s AML/CFT regime from post-9/11 to post-
+pandemic; from al Qaida to AI and digital assets... 
+
+ Corporate Transparency, Beneficial Ownership Disclosure, and 
+Illicit Financial Flows 
+ Historically, a key money laundering vulnerability of the international financial system has been 
+the ability for individuals to create certain legal entities, including in the United States, without 
+having to consistently disclose and update beneficial ownership information (i.e., identifying 
+information of the natural persons who own or control legal entities). Moreover, where beneficial 
+
+ 
+Improving Laundering Laws and Increasing Comprehensive Information Tracking of Criminal Activity in Shell 
+Holdings Act (ILLICIT CASH Act); S. 1889, the True Incorporation Transparency for Law Enforcement Act (the 
+TITLE Act); S. 1883, the Combating Money Laundering, Terrorist Financing, and Counterfeiting Act of 2019; and S. 
+1978, the Corporate Transparency Act of 2019. See Joint Explanatory Statement of the Committee of Conference , 
+beginning on p. 1517 of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, 
+Conference Report to Accompany H.R. 6395, H.Rept. 116-617, December 3, 2020, pp. 2136-2137. 
+
+19 Ibid., p. 2137. 
+20 FinCEN, Prepared Remarks of FinCEN Acting Director Him Das, Delivered Virtually at the American Bankers 
+Association/American Bar Association Financial Crimes Enforcement Conference , January 13, 2022. 
+
+Congressional Research Service 
+
+ 
+
+4 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+disclosure requirements have existed, they have differed across jurisdictions, including with 
+respect to the role of the government in collecting such information and whether such information 
+is publicly accessible. 
+
+In 2005, for example, the U.S. Money Laundering Threat Assessment identified misuse of shell 
+companies and trusts as a key vulnerability to the U.S. financial system: 
+
+Legal entities such as shell companies and trusts are used globally for legitimate business 
+purposes, but because of their ability to hide ownership and mask financial details they 
+have become popular tools for money launderers. 
+
+The use of these legal structure for money laundering is well-established. The United 
+Nations noted in a 1998 report that “the principal forms of abuse of secrecy have shifted 
+from individual bank accounts to corporate bank accounts and then to trust and other 
+corporate forms that can be purchased readily without even the modest initial and ongoing 
+due diligence that is exercised in the banking sector.” 
+
+The competition among certain states to attract legal entities to their jurisdictions has 
+created a “race to the bottom,” and a real money laundering threat.21 
+
+Treasury’s February 2022 National Money Laundering Risk Assessment confirms that such lack 
+of timely access to beneficial ownership information (which reportedly risks delays in federal law 
+enforcement investigations) remained a key U.S. AML/CFT regulatory regime weakness: 
+
+The deliberate misuse of legal entities and arrangements, including limited liability 
+companies and other corporate vehicles, trusts, partnerships, and the use of nominees, 
+continue to be significant tools for facilitating money laundering and other illicit financial 
+activity in the U.S. financial system.22 
+
+This AML/CFT vulnerability has placed the United States under domestic and international 
+pressure, including from the Financial Action Task Force (FATF)—a key intergovernmental 
+AML/CFT standard-setting body, of which the United States was a founding member, to tighten 
+its AML/CFT regime with respect to beneficial ownership disclosure requirements.23 Building on 
+its 2006 criticism of the U.S. government’s AML/CFT regime, FATF’s 2016 review of the U.S. 
+government’s AML/CFT regime reiterated that the “[l]ack of timely access to adequate, accurate 
+and current beneficial ownership (BO) information remains one of the fundamental gaps in the 
+U.S. context.”24 
+
+Since at least the 110th Congress, legislation has been introduced to address long-standing 
+concerns raised by the U.S. government, including federal law enforcement, domestic observers, 
+and international evaluators, about the lack of beneficial ownership transparency among certain 
+U.S.-established legal entities.25 AMLA built on these efforts to enact the foundational mandate 
+for federal beneficial ownership disclosure and information collection in the United States. 
+Implementing AMLA, including the establishment of a federal process for collecting beneficial 
+
+ 
+21 U.S. Department of the Treasury, U.S. Department of Justice, U.S. Department of Homeland Security, Board of 
+Governors of the Federal Reserve System, U.S. Postal Service, “Chapter 8: Shell Companies and Trusts,” Money 
+Laundering Threat Assessment , pp. 47-48. 
+
+22 U.S. Department of the Treasury, National Money Laundering Risk Assessment , February 2022, p. 1. 
+23 See also U.S. rankings in the Basel Institute on Governance, Basel AML Index 2021 , September 2021, and the Tax 
+Justice Network, Financial Secrecy Index 2022 , https://fsi.taxjustice.net/. 
+
+24 FATF, United States: Mutual Evaluation Report, Anti-Money Laundering and Counter-Terrorist Financing 
+Measures , December 2016, p. 4. 
+
+25 See, for example, the Incorporation Transparency and Law Enforcement Assistance Act (S. 2956), introduced by 
+Senator Carl Levin in the 110th Congress on May 1, 2008. 
+
+Congressional Research Service 
+
+ 
+
+5 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ownership information pursuant to the CTA, also supports the Biden Administration’s December 
+2021 U.S. Strategy on Countering Corruption , which identifies “curbing illicit finance” as one of 
+five pillars of the U.S. government’s anti-corruption approach.26 
+
+ AMLA: Key Provisions 
+ Division F of the FY2021 NDAA (P.L. 116-283) is the Anti-Money Laundering Act of 2020 
+(AMLA). AMLA is composed of five distinct titles: 
+
+ Title LXI—Strengthening Treasury Financial Intelligence, Anti-Money 
+
+Laundering, and Countering the Financing of Terrorism Programs 
+
+ Title LXII—Modernizing the Anti-Money Laundering and Countering the 
+
+Financing of Terrorism System 
+
+ Title LXIII—Improving Anti-Money Laundering and Countering the Financing 
+
+of Terrorism Communication, Oversight, and Processes 
+
+ Title LXIV—Establishing Beneficial Ownership Information Reporting 
+
+Requirements (the Corporate Transparency Act or CTA) 
+
+ Title LXV—Miscellaneous 
+
+If or when fully implemented, AMLA has the potential to significantly modernize the existing 
+AML/CFT regulatory framework originally established more than 50 years ago. 
+
+Key AMLA provisions include the following: 
+
+ Establishing beneficial ownership disclosure and transparency. Within 
+
+AMLA is the Corporate Transparency Act (CTA; Title LXIV of Division F of the 
+FY2021 NDAA; §§6401-6403), which for the first time imposes a federal 
+requirement for identifying beneficial owners of certain legal entities (i.e., the 
+natural persons who own or control, directly or indirectly, such entities). 
+
+ Expanding the BSA’s purpose and mandating a review of the AML/CFT 
+
+ regulatory framework. AMLA codified an expansion the BSA’s stated purpose 
+to include preventing illicit financial activity from harming the U.S. financial 
+system and national security (§6101).27 Correspondingly, AMLA mandates 
+potentially significant rulemaking changes to core aspects of the existing 
+AML/CFT regulatory framework, including revising or eliminating “outdated” or 
+“redundant” regulations and enhancing opportunities for financial institutions to 
+enhance their compliance programs through technological innovation (§6216). 
+
+ Promoting public-private partnership and engagement opportunities. AMLA 
+
+codifies opportunities for public-private information sharing, including through a 
+
+ 
+26 Biden Administration, United States Strategy on Countering Corruption , December 2021. 
+27 See, for example, Section 6101(a) of the AMLA, which repealed the prior Section 5311 of Title 31 of the U.S. Code 
+and replaced it with a new declaration of purpose for the BSA that included, in addition to requiring the filing of certain 
+“highly useful” reports and maintenance of certain “highly useful” records, four additional purposes: (1) to prevent 
+money laundering and terrorist financing “through the establishment by financial institutions of reasonably designed 
+risk-based [AML/CFT] programs”; (2) to “facilitate the tracking” of criminally derived money or money “intended to 
+promote criminal or terrorist activity”; (3) to conduct money laundering, terrorism finance, tax evasion, and fraud risk 
+assessments to protect the U.S. financial system from criminal abuse and safeguard U.S. national security”; and (4) to 
+“establish appropriate frameworks for information sharing among financial institutions, their agents and service 
+providers, their regulatory authorities, associations of financial institutions, the Department of the Treasury, and law 
+enforcement authorities.” 
+
+Congressional Research Service 
+
+ 
+
+6 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+“FinCEN Exchange” (§6103), a new Subcommittee on Innovation and 
+Technology under the Bank Secrecy Act Advisory Group (§6207), a Financial 
+Crimes Tech Symposium (§6211), and other mechanisms (e.g., §6214 on 
+“encouraging information sharing and public-private partnerships” and §6306 on 
+“cooperation with law enforcement”). 
+
+ Introducing new staffing options and programs. AMLA directs the 
+
+establishment of an interagency AML/CFT personnel rotation program (§6104), 
+authorizes special hiring authorities for the appointment of certain officials 
+(§6105), codifies a Treasury financial attaché program (§6106), and requires 
+FinCEN to maintain a cadre of analytical experts who can collaborate with other 
+federal agencies (§6304). AMLA also creates new staff positions for domestic 
+FinCEN liaisons (§6107), foreign financial intelligence unit liaisons (§6108), 
+BSA innovation officers (§6208), and BSA information security officers (§6303). 
+
+ Promoting international cooperation on financial crime matters, while 
+
+ protecting financial intelligence from misuse. AMLA directs the Department of 
+the Treasury to increase technical assistance (§6111) and international 
+coordination (§6112) with foreign countries to promote compliance with 
+international AML/CFT standards and best practices, as well as stronger AML 
+legal frameworks and enforcement. AMLA also authorizes a pilot program in 
+which financial institutions subject to U.S. jurisdiction may share SAR 
+information with their foreign branches, subsidiaries, and affiliates (§6212). 
+
+ Strengthening enforcement tools to deter money laundering and other forms 
+
+ of financial crime. AMLA formalizes a mandate to collect data on how BSA 
+reports contribute to actionable investigative leads and prosecution success 
+(§6201). Among other provisions, AMLA also authorizes the application of 
+additional civil penalties for repeat BSA violators (§6309), bars certain BSA 
+violators from serving on boards of U.S. financial institutions (§6310), and adds 
+a new prohibition on the concealment of the source of assets in monetary 
+transactions (§6313). AMLA also authorizes the Secretary of the Treasury and the 
+Attorney General to subpoena records from any foreign bank that maintains a 
+U.S. correspondent account (§6308). 
+
+ Invigorating BSA whistleblower provisions. Modeled in part on the Securities 
+
+and Exchange Commission’s whistleblower program enacted as part of the 
+Dodd-Frank Act in 2010, AMLA significantly revised BSA whistleblower 
+provisions to increase the potential reward amount for whistleblower disclosures, 
+expand who can qualify as a whistleblower, and provide whistleblowers 
+protections against retaliation (§6314). 
+
+ Expanding the BSA’s regulatory scope to include businesses that provide 
+
+ services involving “value that substitutes for currency.” AMLA clarifies that 
+financial agencies and financial institutions (including currency exchanges and 
+money transmitting businesses) covered by the BSA include businesses that 
+provide services related to “value that substitutes for currency” (§6102(d)). 
+Examples of value that may substitute for currency could include some digital 
+assets and virtual currencies. AMLA also redefines “monetary instruments” to 
+include “value that substitutes for any monetary instrument” otherwise already 
+defined in current law. 
+
+Congressional Research Service 
+
+ 
+
+7 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ AMLA Implementation: Rulemakings 
+ A primary aspect of early AMLA implementation has centered on AML/CFT rulemakings, 
+including those required to implement the CTA. This section provides an overview of significant 
+AMLA provisions for which rulemakings may be required for full implementation—and includes 
+information on the status of such rulemakings. While some rulemakings are in progress, others 
+appear delayed. Additionally, FinCEN remains in the process of finalizing several other 
+significant AML-related regulations that predate or are otherwise not specified in AMLA.28 
+
+ The CTA and Beneficial Ownership Disclosure 
+ In one of its most significant rulemaking changes, AMLA established a federal requirement for 
+identifying the beneficial owners of corporate entities. Section 6403 of the CTA, among other 
+provisions, amended the BSA to add a new Section 5336, “Beneficial Ownership Information 
+Reporting Requirements,” to Subchapter II of Chapter 53 of Title 31 of the United States Code .29 
+
+Pursuant to the CTA, those forming certain new legal entities and those owning certain existing 
+entities will be required to provide their full legal name, date of birth, current residential or 
+business street address, and a copy of an acceptable identification document for natural persons 
+who own or control such entities, subject to the definitions. In the CTA, the term beneficial owner 
+ is defined, in part, to mean a person who directly or indirectly owns 25% or more of a legal entity 
+or “exercises substantial control” over it.30 
+
+The CTA designated FinCEN as the central repository for collecting information on the beneficial 
+owners of certain legal entities.31 Covered entities must update beneficial ownership information 
+as it changes. The Secretary of the Treasury is required to evaluate within two years of enactment 
+
+ 
+28 Such proposals seek to address AML/CFT concerns regarding topics such as real estate transaction reports and 
+records, the “meaning of ‘money’ as used in the rules implementing the BSA”—including with respect to convertible 
+virtual currency (e.g., cryptocurrency) and digital assets with legal tender status, and changes to the definition of 
+brokers and dealers in securities to include funding portals for crowd funding. See FinCEN, Anti-Money Laundering 
+Program Requirements for “Persons Involved in Real Estate Closings and Settlements , advance notice of proposed 
+rulemaking (ANPRM), published in the Federal Register , vol. 68, no. 69, April 10, 2003, pp. 17569-17571; FinCEN, 
+ Anti-Money Laundering Regulations for Real Estate Transactions , ANPRM, published in the Federal Register , vol. 86, 
+no. 233, December 8, 2021, pp. 69589-69602; FinCEN, Anti-Money Laundering Regulations for Real Estate 
+Transactions , ANPRM, published in the Federal Register , vol. 87, no. 26, February 8, 2022, pp. 7068-7069; Board of 
+Governors of the Federal Reserve System and FinCEN, Threshold for the Requirement to Collect, Retain, and Transmit 
+Information on Funds Transfers and Transmittals of Funds that Begin or End Outside the United States, and 
+Clarification of the Requirement to Collect, Retain, and Transmit Information on Transactions Involving Convertible 
+Virtual Currencies and Digital Assets with Legal Tender Status , joint notice of proposed rulemaking, published in the 
+ Federal Register , vol. 85, no. 208, October 27, 2020, pp. 68005-68019; FinCEN, Requirements for Certain 
+Transactions Involving Convertible Virtual Currency or Digital Assets , notice of proposed rulemaking (NPRM), 
+published in the Federal Register , vol. 85, no. 247, December 23, 2020, pp. 83840-83862; FinCEN, Amendments to the 
+Definition of Broker or Dealer in Securities , NPRM, published in the Federal Register , vol. 81, no. 64, April 4, 2016, 
+pp. 19086-19094; and U.S. Department of the Treasury, Semiannual Agenda and Regulatory Plan , published in the 
+ Federal Register , vol. 87, no. 151, August 8, 2022, pp. 48324-48328. 
+
+29 The CTA is located in Title LXIV of Division F of the William M. (Mac) Thornberry National Defense 
+Authorization Act for Fiscal Year 2021 (P.L. 116-283). 
+
+30 See Section 6403 of the CTA. 
+31 Covered beneficial owners are defined in the Corporate Transparency Act, in part, to mean persons who directly or 
+indirectly own 25% or more of a legal entity or exercise “substantial control” over it. 
+
+Congressional Research Service 
+
+ 
+
+8 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+whether there is a need to shorten the deadline for entities to update changes in beneficial 
+ownership information (currently set at one year after such information changes).32 
+
+Pursuant to AMLA, FinCEN must store such information in its nonpublic database for at least 
+five years and allow various U.S. government entities and financial institutions to access the 
+information, subject to certain terms. Under the act, penalties for unauthorized disclosure of this 
+information to the public are significant.33 
+
+Regulations to implement the CTA were required within one year of enactment and are now 
+overdue. Following an earlier advance notice of proposed rulemaking (ANPRM) in April 2021, 
+FinCEN released a notice of proposed rulemaking (NPRM) in December 2021 to implement the 
+beneficial ownership reporting requirements under AMLA.34 FinCEN’s December 7, 2021, 
+proposed rule identified two types of reporting companies—domestic and foreign—and FinCEN 
+noted that it expected these to include business trusts, corporations, limited liability companies, 
+and most other limited partnerships.35 Entities established before the effective date of the final 
+rule would have one year to provide ownership information to FinCEN. Those formed after the 
+effective date would have 14 days to provide this information.36 
+
+FinCEN received 458 comments in response to its ANPRM and NPRM.37 The December 2021 
+NPRM is reportedly the first of three proposed rules that FinCEN intends to issue with respect to 
+the implementation of the CTA.38 A second subsequent proposed rule (not yet issued) would 
+detail how FinCEN’s database could be accessed and by whom. A third proposed rule (not yet 
+issued) would seek to update existing customer due diligence requirements for financial 
+institutions, including with respect to beneficial ownership information disclosure. 
+
+The timeline and status of next steps in the rulemaking process remains unclear. According to the 
+Treasury Department’s Semiannual Agenda and Regulatory Plan, published in the Federal 
+Register on August 8, 2022, FinCEN is reviewing the comments it has received in response to its 
+proposed rulemakings and “considering the timing and sequence of the regulatory actions it will 
+take to fulfill the requirements of Section 5336 in light of the issues of regulatory interaction that 
+the comments raise.”39 
+
+ 
+32 31 U.S.C. §5336(b)(1)(E) as added by Section 6403 of AMLA. Pursuant to Section 6403, the Secretary’s review is to 
+be conducted in consultation with the Attorney General and the Secretary of Homeland Security. 
+
+33 Ibid. Unauthorized disclosure or use of the beneficial ownership data may result in a civil penalty of up to $500 for 
+each day that the violation continues or has not been remedied and a criminal fine of up to $250,000 and/or 
+imprisonment for up to five years. If the violation occurs while violating another U.S. law or as part of a pattern of any 
+illegal activity involving more than $100,000 in a 12-month period, violators could be fined up to $500,000 and/or 
+imprisoned up to 10 years. 
+
+34 FinCEN, Beneficial Ownership Information Reporting Requirements , ANPRM, published in the Federal Register , 
+vol. 86, no. 63, April 5, 2021, pp. 17557-17565. 
+
+35 FinCEN, Beneficial Ownership Information Reporting Requirements , NPRM, published in the Federal Register , vol. 
+86, no. 233, December 8, 2021, pp. 69920-69974. See also FinCEN, Fact Sheet: Beneficial Ownership Information 
+Reporting Notice of Proposed Rulemaking (NPRM) , December 7, 2021. 
+
+36 FinCEN, Fact Sheet: Beneficial Ownership Information Reporting Notice of Proposed Rulemaking (NPRM) , 
+December 7, 2021. 
+
+37 FinCEN, Beneficial Ownership Information Reporting Requirements , Regulation Identifier Number 1506-AB49, 
+https://www.regulations.gov/docket/FINCEN-2021-0005. The number of comments refers to the total number of 
+comments posted to this docket. 
+
+38 FinCEN, Fact Sheet: Beneficial Ownership Information Reporting Notice of Proposed Rulemaking (NPRM) , 
+December 7, 2021. 
+
+39 U.S. Department of the Treasury, Semiannual Agenda and Regulatory Plan , published in the Federal Register , vol. 
+
+Congressional Research Service 
+
+ 
+
+9 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+One issue raised in comments to FinCEN’s December 2021 NPRM related to how FinCEN had 
+defined “substantial control” over a covered corporate entity (referred to as a “reporting entity” in 
+the NPRM), for the purposes of determining whether someone is a beneficial owner of that 
+entity;40 and how broadly it defined “ownership interest.”41 In a February 2022, letter to Secretary 
+of the Treasury Janet Yellen and FinCEN Acting Director Das, House Financial Services 
+Committee Chair Maxine Waters, Senate Banking Committee Chair Sherrod Brown, and House 
+Oversight and Reform Committee Chair Carolyn Maloney commended FinCEN for using a 
+definition of “substantial control” the authors characterized as broad and flexible enough to 
+encompass functional control over a reporting entity using novel means of control. The authors 
+also flagged the importance in the NPRM of including a definition of “ownership interest” that 
+encompassed not only equity ownership, but also other informal means to structure ownership 
+that may serve to conceal such ownership, such as unwritten understandings or relationships 
+between individuals. A July 2018, report by the Financial Action Task Force (FATF) on the 
+ Concealment of Beneficial Ownership flagged the use of informal nominees, or “straw men” as 
+nominee shareholders or directors, as a key means of hiding the identities of beneficial owners by 
+criminals.42 On the other hand, a March 2022 letter to Treasury and FinCEN from Ranking House 
+Financial Services Committee Member Patrick McHenry and Ranking House Committee on 
+Small Business Member Blaine Luetkemeyer stated that the definition of “substantial control” 
+used in the NPRM was overly broad.43 
+
+ Status of Other AMLA Rulemaking Requirements 
+ As described below, FinCEN is developing several AMLA rules, including rules on AML/CFT 
+priorities, AML regulations for dealers in antiquities, a pilot program to share SARs, and a 
+process for issuing “no-action” letters. The AMLA contains several other prospective AML/CFT-
+related rulemaking provisions that are in process as well. 
+
+ Rulemaking on AML/CFT Priorities 
+
+Section 6101(b) of the AMLA amends 31 U.S.C. §5318 to require the Secretary of the Treasury to 
+“establish and make public priorities” for AML/CFT policy.44 Pursuant to this requirement, 
+FinCEN issued an initial list of eight AML/CFT priorities on June 30, 2021 (Treasury is required 
+to update its priorities at least once every four years).45 Section 6101(b) of the AMLA further 
+
+ 
+87, no. 151, August 8, 2022, pp. 48324-48328. 
+
+40 As previously noted, under the NPRM, beneficial owners of legal entities covered by the rule are required to report 
+their names and identifying information to FinCEN. 
+
+41 See Letter from Representatives Maxine Waters, Chair of the House Committee on Financial Services, Sherrod 
+Brown, Chair of the Senate Committee on Banking, Housing and Urban Affairs, and Representative Carolyn Maloney, 
+Chair of the House Committee on Oversight and Reform, to Secretary of the Treasury Janet Yellen and Acting FinCEN 
+Director Him Das, February 7, 2022. 
+
+42 FATF and the Egmont Group of Financial Intelligence Units, Concealment of Beneficial Ownership, July 2018, p. 6. 
+43 Letter from Representatives Patrick McHenry, Ranking Member of the House Committee on Financial Services, and 
+Blaine Luetkemeyer, Ranking Member of the House Committee on Small Business, to Secretary of the Treasury Janet 
+Yellen and Acting FinCEN Director Him Das, March 2, 2022, p. 2. 
+
+44 See 31 U.S.C. §5318(h)(4). Pursuant to this provision, the priorities are to be developed in consultation with the 
+Attorney General, federal functional regulators (as defined in section 509 of the Gramm-Leach-Bliley Act), relevant 
+state financial regulators, and relevant national security agencies. 
+
+45 FinCEN, Anti-Money Laundering and Countering the Financing of Terrorism National Priorities , June 30, 2021. 
+The initial eight priorities are (1) corruption; (2) cybercrime, including relevant cybersecurity and virtual currency 
+considerations; (3) foreign and domestic terrorist financing; (4) fraud; (5) transnational criminal organization activity; 
+
+Congressional Research Service 
+
+ 
+
+10 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+requires the Secretary of the Treasury, acting through the FinCEN Director, to, “as appropriate, 
+promulgate regulations” to implement its public AML/CFT policy priorities.46 Such rulemaking 
+was due within 180 days of the issuance of the first AML/CFT policy priorities on June 30, 2021. 
+According to the Treasury Department’s Semiannual Agenda and Regulatory Plan, published in 
+the Federal Register on August 8, 2022, FinCEN intends to issue an NPRM to implement the 
+provisions in Section 6101 of the AMLA.47 
+
+ AML Regulations for Dealers in Antiquities 
+
+Section 6110 of the AMLA requires the Secretary of the Treasury to issue proposed rules within 
+360 days of enactment that subject “a person engaged in the trade of antiquities, including an 
+advisor, consultant, or any other person who engages as a business in the solicitation or the sale of 
+antiquities” to BSA requirements. According to FinCEN, trade in antiquities may facilitate illicit 
+value transfers and be used as a money laundering method by a wide range of terrorist 
+organizations, transnational criminal networks, and other malign actors.48 On March 9, 2021, 
+FinCEN issued a notice to inform financial institutions about anticipated regulatory activity 
+related to antiquities trade.49 On September 24, 2021, FinCEN published an ANPRM in the 
+ Federal Register , launching the regulatory process for applying BSA requirements to persons 
+engaged in the trade in antiquities.50 FinCEN received 37 comments on its ANPRM.51 According 
+to the Department of the Treasury’s Semiannual Agenda and Regulatory Plan, published in the 
+ Federal Register on August 8, 2022, FinCEN intends to issue an NPRM by early 2023.52 
+
+ Pilot SAR Sharing Program 
+
+Unauthorized disclosure of the contents or existence of a SAR—including with foreign branches, 
+subsidiaries, and affiliates of U.S. financial institutions—may result in civil penalties and 
+criminal sanctions. Section 6212 of the AMLA requires the Secretary of the Treasury, in 
+coordination with the FinCEN Director, to issue rules establishing a pilot program to permit 
+ 
+(6) drug trafficking organization activity; (7) human trafficking and human smuggling; and (8) weapons proliferation 
+financing. 
+
+46 The rulemaking requirement is codified at 31 U.S.C. §5318(h)(4)(d). Pursuant to this provision, the rulemaking is to 
+be conducted in consultation with the federal functional regulators and relevant state financial regulators. 
+
+47 U.S. Department of the Treasury, Semiannual Agenda and Regulatory Plan , published in the Federal Register , vol. 
+87, no. 151, August 8, 2022, pp. 48324-48328. 
+
+48 FinCEN, FinCEN Launches Regulatory Process for New Antiquities Regulations , September 23, 2021. Section 6110 
+of the AMLA also required the Secretary of the Treasury, in coordination with the Director of the Federal Bureau of 
+Investigation, the Attorney General, and the Secretary of Homeland Security, to conduct “a study of the facilitation of 
+money laundering and the financing of terrorism through the trade in works of art.” The study was due to the Senate 
+Committee on Banking, Housing, and Urban Affairs and House Committee on Financial Services within 360 days of 
+enactment. According to FinCEN, the study has been completed and submitted to Congress. FinCEN response to CRS 
+inquiry, September 6, 2022. 
+
+49 FinCEN, FinCEN Informs Financial Institutions of Efforts Related to Trade in Antiquities and Art , FIN-2021-NTC2, 
+March 9, 2021. 
+
+50 FinCEN, Anti-Money Laundering Regulations for Dealers in Antiquities , ANPRM, published in the Federal 
+Register , vol. 86, no. 183, September 24, 2021, pp. 53021-53024. See also FinCEN, FinCEN Launches Regulatory 
+Process for New Antiquities Regulations , press release, September 23, 2021. 
+
+51 FinCEN, Anti-Money Laundering Regulations for Dealers in Antiquities , Regulation Identifier Number 1506-AB50, 
+https://www.regulations.gov/docket/FINCEN-2021-0006. The number of comments refers to the total number of 
+comments posted to this docket. 
+
+52 U.S. Department of the Treasury, Semiannual Agenda and Regulatory Plan , published in the Federal Register , vol. 
+87, no. 151, August 8, 2022, pp. 48324-48328. 
+
+Congressional Research Service 
+
+ 
+
+11 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+financial institutions subject to BSA reporting requirements to share SARs and related 
+information otherwise subject to SAR confidentiality limitations with their foreign branches, 
+subsidiaries, and affiliates. 
+
+Unless the Secretary authorizes a case-specific exception and notifies the Senate Committee on 
+Banking, Housing, and Urban Affairs and House Committee on Financial Services that such an 
+exception is in the national security interest of the United States, participating financial 
+institutions may not share SAR information with foreign branches, subsidiaries, or affiliates 
+located in China or Russia. Moreover, they may not share SAR information with foreign 
+branches, subsidiaries, or affiliates located in jurisdictions identified as a state sponsor of 
+terrorism, subject to U.S. sanctions, or that “the Secretary has determined cannot reasonably 
+protect the security and confidentiality of such information.” 
+
+The pilot program would terminate three years after enactment, but it may be extended up to two 
+additional years if the Secretary reports to the Senate Committee on Banking, Housing, and 
+Urban Affairs and House Committee on Financial Services that authorizing such an extension is 
+in the national interest of the United States, among other requirements. On January 25, 2022, 
+FinCEN published an NPRM in the Federal Register for such a time-limited pilot program.53 
+FinCEN received 17 comments on its NPRM.54 According to the Department of the Treasury’s 
+Semiannual Agenda and Regulatory Plan, published in the Federal Register on August 8, 2022, 
+FinCEN intends to issue a final rule by the end of 2022.55 
+
+ No-Action Letter Process 
+
+Section 6305 of the AMLA requires the FinCEN Director to conduct an assessment on whether 
+FinCEN should establish a process for issuing BSA “no-action” letters.56 As described in Section 
+6305 of the AMLA, the issuance of “no-action” letters could involve FinCEN responding to 
+inquiries concerning the applicability of BSA and related AML/CFT provisions to specific 
+conduct, along with requests for an official statement as to whether FinCEN or any relevant 
+federal functional regulator intends to take an enforcement action with respect to such conduct. In 
+turn, Section 6305 of the AMLA requires the Secretary of the Treasury to submit a report to the 
+Senate Committee on Banking, Housing, and Urban Affairs and the House Committee on 
+Financial Services, within 180 days of enactment, with FinCEN’s findings and determinations, as 
+well as to propose rulemakings, as appropriate, to implement such findings and determinations.57 
+On June 28, 2021, FinCEN issued the required report, indicating that “FinCEN assesses that it 
+should establish a no-action letter process through rulemaking, provided sufficient resources are 
+
+ 
+53 FinCEN, Pilot Program on Sharing of Suspicious Activity Reports and Related Information with Foreign Branches, 
+Subsidiaries, and Affiliates , NPRM, published in the Federal Register , vol. 87, no. 16, January 25, 2022, pp. 3719-
+3729. See also FinCEN, FinCEN Issues Proposed Rule for Suspicious Activity Report Sharing Pilot Program to 
+Combat Illicit Finance Risks , press release, January 24, 2022. 
+
+54 FinCEN, Pilot Program on Sharing of Suspicious Activity Reports and Related Information with Foreign Branches, 
+Subsidiaries, and Affiliates, Regulation Identifier Number 1506-AB51 , https://www.regulations.gov/docket/FINCEN-
+2022-0002. The number of comments refers to the total number of comments posted to this docket. 
+
+55 U.S. Department of the Treasury, Semiannual Agenda and Regulatory Plan , published in the Federal Register , vol. 
+87, no. 151, August 8, 2022, pp. 48324-48328. 
+
+56 Pursuant to Section 6305(a), FinCEN’s assessment is to be conducted in consultation with the Attorney General, 
+federal functional regulators, state bank supervisors, state credit union supervisors, and other federal agencies, as 
+appropriate. 
+
+57 Pursuant to Section 6305(b), the Secretary’s report is to be submitted in coordination with the Director of the Federal 
+Bureau of Investigation, Attorney General, Secretary of Homeland Security, and federal functional regulators. 
+
+Congressional Research Service 
+
+ 
+
+12 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+made available.”58 On June 6, 2022, FinCEN published an ANPRM in the Federal Register .59 
+FinCEN received 25 comments on its ANPRM.60 
+
+ Other Prospective Rulemakings 
+
+Other AMLA provisions may involve rulemakings for which indications of progress are not 
+publicly available as of the date of this report’s publication. Such provisions include the 
+following: 
+
+ Section 6103 of the AMLA establishes a “FinCEN Exchange” to facilitate 
+
+voluntary public-private information sharing partnership between law 
+enforcement agencies, national security agencies, financial institutions, and 
+FinCEN. The provision also requires FinCEN to, “as appropriate, promulgate 
+regulations that establish procedures for the protection of information shared and 
+exchanged between FinCEN and the private sector” through the FinCEN 
+Exchange.61 AMLA does not provide a deadline for the issuance of such 
+regulations. 
+
+ Section 6204 of the AMLA requires the Secretary of the Treasury to conduct a 
+
+formal review of the financial institution reporting requirements relating to 
+currency transactions reports (CTRs) and SARs—and potential prospects for 
+“streamlining requirements” for such reports.62 Section 6204(c) of the AMLA 
+requires the Secretary of the Treasury to submit a report to Congress within one 
+year of enactment with the Secretary’s findings and determinations, as well as 
+proposed rulemakings.63 
+
+ Section 6205 of the AMLA requires the Secretary of the Treasury to review and 
+
+determine whether the dollar thresholds, including aggregate thresholds, for 
+CTRs and SARs should be adjusted.64 Section 6205(c) of the AMLA requires the 
+Secretary of the Treasury to publish a report with the Secretary’s findings as well 
+as proposed rulemakings within one year of enactment.65 Once every five years 
+
+ 
+58 FinCEN, A Report to Congress: Assessment of No-Action Letters in Accordance with Section 6305 of the Anti-Money 
+Laundering Act of 2020 , June 28, 2021, p. 14. 
+
+59 FinCEN, No-Action Letter Process , ANPRM, published in the Federal Register , vol. 87, no. 108, June 6, 2022, pp. 
+34224-34228. See also FinCEN, FinCEN Issues Advance Notice of Proposed Rulemaking for No-Action Letter 
+Process , press release, June 3, 2022. 
+
+60 FinCEN, No-Action Letter Process, Regulation Identifier Number 1506-AB55 , https://www.regulations.gov/docket/
+FINCEN-2022-0007. The number of comments refers to the total number of comments posted to this docket. 
+
+61 The regulations requirement is codified at 31 U.S.C. §310(d)(5)(A). 
+62 Pursuant to Section 6204(a), the Secretary is to conduct the review in consultation with the Attorney General, federal 
+law enforcement agencies, Secretary of Homeland Security, federal functional regulators, state bank supervisors, state 
+credit union supervisors, and other relevant stakeholders. 
+
+63 Pursuant to Section 6204(c), the Secretary is to submit the required report in consultation with the Attorney General, 
+federal law enforcement agencies, Director of National Intelligence, Secretary of Homeland Security, and federal 
+functional regulators, On December 15, 2021, FinCEN published a request for information (RFI) that sought “comment 
+on ways to streamline, modernize, and update” the U.S. AML/CFT regime. Comments received from this RFI may 
+inform Treasury’s approach to implementing this provision. 
+64 Pursuant to Section 6205(a), the Secretary’s review and determinations are to be conducted in consultation with the 
+Attorney General, Director of National Intelligence, Secretary of Homeland Security, federal functional regulators, 
+state bank supervisors, state credit union supervisors, and other relevant stakeholders. 
+
+65 Pursuant to Section 6205(c), the Secretary’s report is to be published in consultation with the Attorney General, 
+Director of National Intelligence, Secretary of Homeland Security, federal functional regulators, state bank supervisors, 
+
+Congressional Research Service 
+
+ 
+
+13 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+during the 10-year period after AMLA’s enactment, the Secretary is also required 
+to reevaluate the previous findings and “propose rulemakings, as appropriate, in 
+response to the evaluation required.” 
+
+ Section 6209 of the AMLA requires the Secretary of the Treasury to “issue a rule 
+
+to specify ... the standards by which financial institutions are to test the 
+technology and related technology internal processes” for facilitating AML/CFT 
+compliance (e.g., machine learning or other enhanced data analytics processes). 
+AMLA does not provide a deadline for the issuance of such “testing methods 
+rulemaking.”66 
+
+ Section 6314(a) of the AMLA amends 31 U.S.C. §5323 to update AML/CFT-
+
+related whistleblower incentives and protections. The amended U.S. Code 
+provision also authorizes the Secretary of the Treasury, in consultation with the 
+Attorney General, to “issue such rules and regulations as may be necessary or 
+appropriate to implement the [updated whistleblower] provisions.”67 AMLA does 
+not provide a deadline for the issuance of potential rules and regulations. 
+
+ AMLA Implementation: Reporting Requirements 
+ The following section describes AMLA reporting requirements, some of which have been 
+completed while others remain ongoing or pending. 
+
+ CTA Reporting Requirements 
+ Pursuant to the CTA, assessment reports on the functioning of the beneficial ownership registry 
+are due one year after the effective date of implementing regulations and annually thereafter for 
+two years.68 Moreover, exempt entities are subject to “continuous review” for involvement in 
+“significant abuse relating to money laundering, the financing of terrorism, proliferation finance, 
+serious tax fraud, or any other financial crime.”69 The CTA additionally requires the Secretary of 
+the Treasury to prepare reports on FinCEN’s disclosure of beneficial ownership information to 
+nonfederal law enforcement agencies,70 and remediation actions to take in the event of a 
+cybersecurity breach of the beneficial ownership database.71 It also requires the Inspector General 
+of the Department of the Treasury to submit to Congress periodic reports on external user 
+
+ 
+state credit union supervisors, and other relevant stakeholders. 
+
+66 The rulemaking requirement is codified at 31 U.S.C. §5318(o)(1). 
+67 The rulemaking authority is codified at 31 U.S.C. §5323(i). On January 31, 2022, the Regulatory Information Service 
+Center published in the Federal Register a list of FinCEN’s regulatory priorities for FY2022, which included a 
+statement of FinCEN’s intention to issue an NPRM relating to Section 6314 of the AMLA. See Regulatory Information 
+Service Center, Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions—Fall 2021 , 
+published in the Federal Register , vol. 87, no. 20, January 31, 2022, p. 5142. 
+
+68 31 U.S.C. §5336(b)(6) as added by Section 6403 of AMLA. 
+69 31 U.S.C. §5336(i) as added by Section 6403 of AMLA. 
+70 31 U.S.C. §5336(c)(9) as added by Section 6403 of AMLA. The reports are to be submitted to the Senate Committee 
+on Banking, Housing, and Urban Affairs and the House Committee on Financial Services beginning not later than one 
+year after the effective date of implementing regulations and annually thereafter for five years. 
+
+71 31 U.S.C. §5336(h)(5)(C) as added by Section 6403 of AMLA. 
+
+Congressional Research Service 
+
+ 
+
+14 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+comments or complaints related to the beneficial ownership information notification and 
+collection process.72 
+
+ Threat Pattern and Trend Information73 
+ Section 6206 of the AMLA amends 31 U.S.C. §5318(g) to require the FinCEN Director to 
+“publish threat pattern and trend information,” including typologies related to “emerging money 
+laundering and terrorist financing threat patterns and trends.” Such reports, required by AMLA to 
+be published at least semiannually, are intended to “provide meaningful information about the 
+preparation, use, and value of” BSA reporting by financial institutions. To date, FinCEN has 
+issued two such analytic reports, including Illicit Finance Threat Involving Wildlife Trafficking 
+and Related Trends in Bank Secrecy Act Data (December 20, 2021) and Ransomware Trends in 
+Bank Secrecy Act Data between January 2021 and June 2021 (October 15, 2021).74 
+
+ Review of Regulations and Guidance 
+ Section 6216 of the AMLA requires the Secretary of the Treasury to conduct a formal review of 
+AML/CFT regulations to ensure that “appropriate safeguards” are in place “to protect the 
+financial system from threats,” including the continued requirement of certain reports and records 
+that remain “highly useful in countering financial crime.”75 The review is also to identify 
+regulations and guidance that “may be outdated, redundant, or otherwise do not promote a risk-
+based” AML/CFT regime for financial institutions, including any regulations and guidance that 
+do not conform to international AML/CFT standards. 
+
+The review, containing all findings and determinations, including administrative or legislative 
+recommendations, was due to Congress within one year of AMLA’s enactment. Beginning the 
+process of implementing this provision, FinCEN published a request for information (RFI) on 
+December 15, 2021, that sought “comment on ways to streamline, modernize, and update” the 
+U.S. AML/CFT regime in order to “protect U.S. national security in a cost-effective and efficient 
+manner.”76 FinCEN received 140 comments on its RFI.77 
+
+ 
+72 31 U.S.C. §5336(h)(4)(B) as added by Section 6403 of AMLA. 
+73 Since the enactment of AMLA, FinCEN has published other reports on anti-money laundering/countering the 
+financing of terrorism (AML/CFT) concerns related to threat patterns and trend information that are not specified in 
+AMLA. Such publications include several advisories on certain illicit finance threats, including fraud and financial 
+crimes related to the COVID-19 pandemic (FIN-2021-A001 and FIN-2021-A002), ransomware and ransom payments 
+(FIN-2021-A004), kleptocracy and foreign public corruption (FIN-2022-A001), and elder financial exploitation (FIN-
+2022-A002). 
+
+74 On the issue of ransomware, FinCEN also published an advisory. See FinCEN, Advisory on Ransomware and the 
+Use of the Financial System to Facilitate Ransom Payments , FIN-2021-A004, November 8, 2021. 
+
+75 Pursuant to Section 6216(a), the Secretary’s review is to be conducted in consultation with the federal functional 
+regulators, Financial Institutions Examination Council, Attorney General, federal law enforcement agencies, Director 
+of National Intelligence, Secretary of Homeland Security, and Commissioner of Internal Revenue. 
+
+76 FinCEN, Review of Bank Secrecy Act Regulations and Guidance , request for information and comment (RFI), 
+published in the Federal Register , vol. 86, no. 238, December 15, 2021, pp. 71201-71207. See also FinCEN, FinCEN 
+Seeks Comments on Modernization of U.S. AML/CFT Regulatory Regime , press release, December 14, 2021. 
+
+77 FinCEN, Review of Bank Secrecy Act Regulations and Guidance – Request for Information, 
+https://www.regulations.gov/docket/FINCEN-2021-0008. The number of comments refers to the total number of 
+comments posted to this docket. 
+
+Congressional Research Service 
+
+ 
+
+15 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ Other Treasury Department Reporting Requirements 
+ In addition to the AMLA provisions discussed above, AMLA contains other reporting provisions 
+requiring the Secretary of the Treasury or the FinCEN Director to submit various reports to 
+Congress. Some of these reporting requirements have been delegated to FinCEN or other 
+organizational units within Treasury, such as the Office of Terrorist Financing and Financial 
+Crimes (TFFC). Moreover, some of these reports may not have been issued publicly and may 
+have instead been specifically provided to the Senate Committee on Banking, Housing, and 
+Urban Affairs and the House Committee on Financial Services. 
+
+ Section 6103 of the AMLA amends 31 U.S.C. §310 to require the Secretary of 
+
+the Treasury to submit reports to the Senate Committee on Banking, Housing, 
+and Urban Affairs and the House Committee on Financial Services on efforts 
+undertaken by the FinCEN Exchange. The first report was due within one year of 
+AMLA’s enactment and once every two years thereafter for the next five years.78 
+
+ Section 6105(c) of the AMLA requires the Secretary of the Treasury to submit 
+
+reports to the Senate Committee on Banking, Housing, and Urban Affairs and the 
+House Committee on Financial Services on the use of special hiring authorities 
+for FinCEN and Office of Terrorism and Financial Intelligence personnel. The 
+first report was due within one year of AMLA’s enactment and once every two 
+years thereafter for the next five years.79 
+
+ Section 6107 of the AMLA amends 31 U.S.C. §310 to require the FinCEN 
+
+Director to submit reports to the Senate Committee on Banking, Housing, and 
+Urban Affairs and the House Committee on Financial Services on the next-year 
+objectives of the AMLA-created Office of Domestic Liaison and past-year 
+activities. The first report was due within one year of AMLA’s enactment and 
+once every two years thereafter for the next five years.80 
+
+ Section 6110(c) of the AMLA requires the Secretary of the Treasury to “perform 
+
+a study on the facilitation of money laundering and the financing of terrorism 
+through the trade in works of art.”81 The report was due to the Senate Committee 
+on Banking, Housing, and Urban Affairs and the House Committee on Financial 
+Services within 360 days of AMLA’s enactment.82 
+
+ 
+78 Information on the FinCEN Exchange is available at https://www.fincen.gov/resources/financial-crime-enforcement-
+network-exchange. According to FinCEN, the required first report has been completed and submitted to Congress. 
+FinCEN response to CRS inquiry, September 6, 2022. 
+
+79 Sections 6105(a) and 6105(b) of the AMLA amended 31 U.S.C. §310 and 31 U.S.C. §312, respectively, to authorize 
+the Secretary of the Treasury to appoint to FinCEN and the Office of Terrorism and Financial Intelligence personnel 
+“without regard to the provisions of section 3309 through 3318 of title 5, candidates directly to positions in the 
+competitive service, as defined in section 2102 of that title ... .” According to FinCEN, direct hiring authority was 
+“operationalized” as of February 26, 2021. See FinCEN, Message from the FinCEN Director: 180-Day Update on 
+AML Act Implementation , June 30, 2021. According to FinCEN, the required first report has been completed and 
+submitted to Congress. FinCEN response to CRS inquiry, September 6, 2022. 
+
+80 According to FinCEN, the required first report has been completed and submitted to Congress. FinCEN response to 
+CRS inquiry, September 6, 2022. 
+
+81 Pursuant to Sections 6110(c) and 6110(d), the Secretary’s review and report are to be completed in coordination with 
+the Director of the Federal Bureau of Investigation, Attorney General, and Secretary of Homeland Security. 
+
+82 According to FinCEN, the study has been completed and submitted to Congress. FinCEN response to CRS inquiry, 
+September 6, 2022. 
+
+Congressional Research Service 
+
+ 
+
+16 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ Section 6111 of the AMLA requires the Secretary of the Treasury to submit 
+
+reports to Congress on technical assistance, including assistance to promote 
+compliance with international AML/CFT standards and best practices, provided 
+by the Treasury Department’s Office of Technical Assistance. The first report was 
+due within one year of AMLA’s enactment and once every two years thereafter 
+for the next five years.83 
+
+ Section 6210 of the AMLA requires the Secretary of the Treasury to submit a 
+
+report to the Senate Committee on Banking, Housing, and Urban Affairs and the 
+House Committee on Financial Services that assesses “the impact of financial 
+technology on financial crimes compliance, including with respect to money 
+laundering, the financing of terrorism, proliferation finance, serious tax fraud, 
+trafficking, sanctions evasion, and other illicit finance.”84 The report was due 
+within one year of AMLA’s enactment. 
+
+ Section 6215(b) of the AMLA requires the U.S. Government Accountability 
+
+Office (GAO) to conduct an analysis of financial services “de-risking”—the 
+concern that AML/CFT and sanctions-related compliance decisionmaking may 
+have the unintended consequence of reducing financial services access to 
+nonprofit and international development organizations carrying out humanitarian 
+activities in high-risk jurisdictions. In turn, Section 6215(c) requires the Secretary 
+of the Treasury to undertake a formal review and submit a report to the Senate 
+Committee on Banking, Housing, and Urban Affairs and the House Committee 
+on Financial Services that includes “a strategy to reduce de-risking and adverse 
+consequences related to de-risking.”85 
+
+ Section 6506 of the AMLA requires the Secretary of the Treasury to submit to 
+
+Congress a report on trade-based money laundering (TBML) and proposed 
+strategies to combat TBML. The report was due within one year of AMLA’s 
+enactment.86 
+
+ Section 6507 of the AMLA requires the Secretary of the Treasury to submit to 
+
+Congress a report on Chinese money laundering and a strategy to counter such 
+laundering activity. The report was due within one year of AMLA’s enactment. 
+
+ Section 6508 of the AMLA requires the Secretary of the Treasury to study and 
+
+submit to the Senate Committee on Banking, Housing, and Urban Affairs and the 
+House Committee on Financial Services a report on the efforts of authoritarian 
+regimes to exploit the U.S. financial system and recommendations for legislative, 
+regulatory, or U.S. financial institution action to address such exploitation.87 The 
+report is due within two years of AMLA’s enactment. 
+
+ 
+83 According to FinCEN, the required first report has been completed and submitted to Congress. FinCEN response to 
+CRS inquiry, September 20, 2022. 
+
+84 Pursuant to Section 6210, the Secretary’s financial technology assessment is to be conducted in consultation with 
+financial regulators, technology experts, national security experts, law enforcement, and any other group the Secretary 
+determines is appropriate. 
+
+85 Pursuant to Section 6215(c), the Secretary’s review and strategy are to be undertaken in consultation with the federal 
+functional regulators, state bank supervisors, state credit union supervisors, and appropriate public- and private sector 
+stakeholders. 
+
+86 As authorized by AMLA, the Secretary of the Treasury may enter into a contract with a private third-party entity to 
+carry out the study on trade-based money laundering. 
+
+87 Pursuant to Section 6508, the Secretary’s study is to be conducted with the Attorney General, in consultation with the 
+
+Congressional Research Service 
+
+ 
+
+17 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ GAO Reporting Requirements 
+
+AMLA directs GAO to conduct several reports, some of which have been completed, that examine the fol owing 
+topics: 
+ 
+
+Financial services de-risking (§6215(b)).88 
+
+ 
+
+Findings and determinations of annual audits of the procedures and safeguards established as part of the 
+Treasury Department’s beneficial ownership registry process (§6403). 
+
+ 
+
+The effectiveness of incorporation practices implemented by AMLA to combat incorporation abuses and 
+detect, prevent, or prosecute financial crimes (§6502(a)). 
+
+ 
+
+Il icit finance risks posed by entities excepted from beneficial ownership reporting requirements (§6502(c)). 
+
+ 
+
+Beneficial ownership disclosure regimes for other legal entities, such as partnerships and trusts, formed or 
+registered at the state level and an evaluation of il icit finance concerns (§6502(d)). 
+
+ 
+
+Best practices on public-private partnership feedback loops for financial intelligence information sharing 
+(§6503). 
+
+ 
+
+The effectiveness of the CTR regime, the importance of CTRs to law enforcement, and the effects of raising 
+the CTR threshold (§6504). 
+
+ 
+
+The nexus of il icit actors (transnational criminal organizations, terrorists, and others), contraband trafficking 
+(people, drugs, weapons, cash, child sexual exploitation materials, and other il icit goods), and the methods 
+and typologies associated with corresponding il icit financial activity—as well as policy options to address 
+“trafficking, il icit flows, laundering, and exploitation” (§6505(b)).89 
+
+ 
+
+How various payment systems and methods, including virtual currencies and online marketplaces, are used to 
+facilitate human trafficking and drug trafficking (§6505(c)).90 
+
+ Selected Issues for Congress 
+ In conducting oversight and contemplating further legislative reforms to the U.S. AML 
+framework, Congress may consider several key areas of AMLA implementation, including (1) 
+challenges in meeting AMLA implementation deadlines, (2) FinCEN funding for AMLA 
+implementation, (3) the status of beneficial ownership rulemaking and establishing a beneficial 
+ownership registry, (4) the law enforcement implications of AMLA implementation, and (5) 
+pending bills related to FinCEN, the BSA and AML/CFT policy. 
+
+ Challenges in Meeting AMLA Implementation Deadlines 
+ Congressional oversight of AMLA implementation may continue to focus on whether FinCEN 
+can meet the statutory deadlines for regulatory activity and reporting requirements. AMLA 
+implementation deadlines were a critical topic of concern during the April 28, 2022 hearing with 
+Acting FinCEN Director Das, held by the House Committee on Financial Services. Further delays 
+may raise questions regarding FinCEN’s ability or willingness to prioritize AMLA 
+implementation. 
+
+ 
+heads of other relevant national security, intelligence, and law enforcement agencies. 
+
+88 See GAO, Bank Secrecy Act: Views on Proposals to Improve Banking Access for Entities Transferring Funds to 
+High-Risk Countries , GAO-22-104792, December 16, 2021. 
+
+89 See GAO, Trafficking and Money Laundering: Strategies Used by Criminal Groups and Terrorists and Federal 
+Efforts to Combat Them , GAO-22-104807, December 21, 2021. 
+
+90 See GAO , Trafficking: Use of Online Marketplaces and Virtual Currencies in Drug and Human Trafficking, GAO-
+22-105101 , February 14, 2022. 
+
+Congressional Research Service 
+
+ 
+
+18 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+According to Acting FinCEN Director Das, a lack of resources has been the driving factor 
+hampering the agency’s ability to fully comply with AMLA’s requirements: 
+
+Timely and effective implementation of the AML Act is our top priority.... It’s important 
+that we get it done right and we get it done quickly. We’ve accomplished a lot, but we also 
+recognize that we need to do more. As you are aware, we are missing deadlines. And to be 
+blunt, we will likely continue to do so because ... our budget situation has required us to 
+make significant trade-offs among competing priorities.91 
+
+FinCEN reports that funding shortfalls for AMLA implementation have particularly limited its 
+ability to comply with AMLA’s requirements, including to establish domestic and international 
+FinCEN liaisons and other new staffing requirements.92 In the same April 2022 testimony, Acting 
+FinCEN Director Das further asserted that limited resources are also slowing the agency’s efforts 
+to implement AMLA’s whistleblower provisions (including staffing a new Office of the 
+Whistleblower, reviewing tips and referring appropriate matters for investigation, and drafting 
+regulations to further enhance the program).93 As of FY2022, FinCEN maintained a staff of less 
+than 300 full-time equivalent positions, including support staff—a staffing level that some 
+observers indicate may challenge the agency from effectively achieving its broad and arguably 
+growing mandate.94 
+
+ FinCEN Funding for AMLA Implementation 
+ Section 6509 of AMLA authorizes appropriations for AMLA implementation. Specifically, 
+AMLA authorizes the following amounts for FinCEN: 
+
+ $136 million for FY2021; 
+ $60 million for FY2022; 
+ $35 million annually for FY2023-2026; and 
+ “such sums as may be necessary” to carry out the beneficial ownership 
+
+information reporting requirements under 31 U.S.C. §5336 for each of the three 
+fiscal years beginning on the effective date of beneficial ownership regulations 
+required by AMLA. 
+
+As part of its annual appropriations activity, Congress may consider FinCEN’s requests for 
+funding to facilitate AMLA implementation.95 
+
+ 
+91 Prepared statement by Himamauli Das, FinCEN Acting Director, before the House Committee on Financial Services, 
+April 28, 2022, p. 9. 
+
+92 Ibid., p. 9. 
+93 Ibid., pp. 11-12. 
+94 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 3. FinCEN staffing levels, relative to its statutory mandate, have 
+long been identified as a policy challenge. See for example GAO, Money Laundering: FinCEN’s Law Enforcement 
+Support, Regulatory, and International Roles , GAO/T-GGD-98-83, April 1, 1998; and Matthew Collin, “What the 
+FinCEN Leaks Reveal about the Ongoing War on Dirty Money,” Brookings, September 25, 2020. 
+95 Some Members of Congress have advocated for FinCEN to receive funding expressly for AMLA implementation. 
+See, for example, Letter from Representative Maxine Waters, Chair of the House Financial Services Committee, to the 
+Chair and Ranking Member of the House Appropriations Subcommittee on Financial Services and General 
+Government Subcommittee, April 12, 2021; Letter from 14 Members of Congress to the Chair and Ranking Member of 
+the House Appropriations Subcommittee on Financial Services and General Government, April 27, 2022; Letter from 
+23 Senators to the Chair and Ranking Member of the Senate Appropriations Subcommittee on Financial Services, May 
+12, 2022. 
+
+Congressional Research Service 
+
+ 
+
+19 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ For FY2021, the Treasury Department estimated that the minimum amount of 
+
+new FinCEN funding necessary to implement AMLA, including the CTA, would 
+be $74.3 million; Congress, however, did not appropriate Treasury’s requested 
+supplemental funding for AMLA implementation in FY2021.96 
+
+ For FY2022, the President’s annual budget request included approximately 
+
+$190.5 million for FinCEN—of which FinCEN requested $60.3 million 
+specifically for AMLA implementation, including funding for 80 full-time 
+equivalent (FTE) positions to implement AMLA.97 
+
+ For FY2023, the President’s annual budget request included approximately 
+
+$210.3 million for FinCEN—of which FinCEN requested $46.4 million 
+specifically for AMLA implementation, including funding for 115 FTE positions 
+to implement AMLA.98 
+
+Appropriated funding for FinCEN in FY2022, which does not specify what proportion of total 
+FinCEN funding should be allocated to AMLA implementation, fell short of the President’s 
+budget request. Congress appropriated funding to FinCEN in the Consolidated Appropriations 
+Act, 2022 (P.L. 117-103). Division E of the act, the Financial Services and General Government 
+Appropriations Act, 2022, provided FinCEN with a total of $161.0 million—up from 
+approximately $127.0 million appropriated in FY2021, but below the Administration’s $190.5 
+million budget request for FY2022.99 
+
+According to the Joint Explanatory Statement accompanying FY2022 appropriations, the act 
+“includes funds for FinCEN to develop and maintain a national beneficial ownership database, 
+and for staffing and support costs to implement and enforce the other new requirements” 
+associated with AMLA, including the CTA.100 FinCEN, however, has indicated that FY2022 
+appropriations provided funding for approximately four of the 80 requested FTE positions.101 
+Another source of funds for CTA implementation has been the Treasury Forfeiture Fund (TFF), 
+administered by the Treasury Executive Office for Asset Forfeiture (TEOAF).102 TEOAF 
+Strategic Support obligations for FY2021-2023 are supporting the initial development costs for 
+ 
+96 “Appendix A: FinCEN – FY 2021 NDAA Cost Estimate (AML Act and CTA),” attached to letter from 
+Representative Maxine Waters, Chair of the House Financial Services Committee, to the Chair and Ranking Member of 
+the House Appropriations Subcommittee on Financial Services and General Government Subcommittee, April 12, 
+2021. 
+
+97 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2022 , p. 4. 
+
+98 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 3. 
+
+99 Division N of the same act, the Ukraine Supplemental Appropriations Act, 2022, provided FinCEN with an 
+additional $19 million “to respond to the situation in Ukraine and for related expenses.” Section 602 of the Additional 
+Ukraine Supplemental Appropriations Act, 2022 (P.L. 117-128) provides an additional $52 million to the Department 
+of the Treasury “to respond to the situation in Ukraine and for related expenses” and provided that such funds may be 
+transferred to other appropriation accounts of the Department of the Treasury. Of the $52 million appropriated, the 
+Department of the Treasury transferred $22.3 million to FinCEN. FinCEN response to CRS inquiry, September 20, 
+2022. 
+
+100 Joint Explanatory Statement, Financial Services and General Government Appropriations Act, 2022, Division E of 
+the Consolidated Appropriations Act, 2022 (P.L. 117-103), p. 5. 
+
+101 FinCEN response to CRS inquiry, March 22, 2022. 
+102 See 31 U.S.C. §9705; as described by the Treasury Department, TEOAF “Strategic Support allows TEOAF to fund 
+priority Federal law enforcement initiatives with remaining unobligated balances at the close of the fiscal year, after an 
+amount is reserved for the next fiscal year’s operations.” U.S. Department of the Treasury, Treasury Executive Office of 
+Asset Forfeiture: Congressional Budget Justification and Annual Performance Report and Plan, FY2023 , p. 3. 
+
+Congressional Research Service 
+
+ 
+
+20 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+the establishment of a FinCEN information technology (IT) platform to securely collect, process, 
+store, and disseminate beneficial ownership information in a system to be known as the 
+Beneficial Ownership Secure System (BOSS).103 
+
+Congress is considering FY2023 appropriations for FinCEN. On June 28, 2022, the House 
+Committee on Appropriations reported the Financial Services and General Government 
+Appropriations Bill, 2023 (H.Rept. 117-393, accompanying H.R. 8254). With respect to FinCEN 
+funding, the committee recommended that FinCEN receive the full amount requested in its 
+FY2023 budget request (approximately $210.3 million). 
+
+The Committee strongly supports the critical work performed by the Department of the 
+Treasury in combating terrorist financing and money laundering. The enactment of the 
+Anti-Money Laundering Act and Corporate Transparency Act in early 2021 represented 
+the first comprehensive revision to anti-money laundering and countering the financing of 
+terrorism law in nearly 20 years.104 
+
+H.Rept. 117-393 further noted: 
+
+The recommendation supports FinCEN’s continued implementation of the provisions of 
+the Anti-Money Laundering Act of 2020 (AMLA). Within AMLA, the Corporate 
+Transparency Act (CTA) includes requirements for corporations, limited liability 
+companies, and similar entities, to report on the beneficial ownership of these entities, and 
+for FinCEN to develop a system to collect and secure this information. Once fully 
+implemented, these actions will help protect the U.S. financial system from money 
+laundering and other illicit financial exchanges and make it harder for bad actors, including 
+Russian oligarchs, to evade oversight and conceal proceeds of corrupt acts using shell 
+companies and other legal entities.... Further, the Committee urges FinCEN and the 
+Department to proceed expeditiously to complete the rulemaking and other requirements 
+in order to fully implement the mandates of AMLA/CTA.105 
+
+ Status of Beneficial Ownership Rulemaking and Registry 
+ As noted above, FinCEN remains in the early stages of CTA implementation. When Acting 
+FinCEN Director Das was asked directly during the April 28, 2022 House Financial Services 
+Committee hearing about when the beneficial ownership database would be ready, Das said, “I do 
+not have a timeline for the establishment of the database.”106 To accomplish this new collection of 
+beneficial ownership information, FinCEN asserts it would need to invest more heavily in its 
+information technology (IT) platform, which, as FinCEN describes, will be “the foundational 
+architecture for the CTA beneficial ownership system.”107 In FY2021 and FY2022, FinCEN has 
+reportedly invested approximately $37.4 million on the development of BOSS, drawing from a 
+combination of TEOAF Strategic Support and appropriated funds.108 
+
+ 
+103 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2022 , p. 19; U.S. Department of the Treasury, Financial Crimes Enforcement 
+Network: Congressional Budget Justification and Annual Performance Plan and Report, FY2023 , p. 15. 
+
+104 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2023 , p. 4. 
+
+105 H.Rept. 117-393, accompanying H.R. 8254, p. 21. 
+106 See CQ transcripts, House Financial Services Committee Holds Hearing on Financial Crimes Enforcement 
+Network , April 28, 2022. 
+
+107 U.S. Department of the Treasury, Financial Crimes Enforcement Network: Congressional Budget Justification and 
+Annual Performance Plan and Report, FY2022 , May 2021, p. 19. 
+
+108 CRS interview with FinCEN, September 16, 2022. 
+
+Congressional Research Service 
+
+ 
+
+21 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+Some observers have contended that the future success of the U.S. beneficial ownership registry 
+may depend on how accessible it is to parties who require the information. Some have suggested 
+that while the CTA is clear on prohibiting public access to this information, FinCEN may have 
+some discretion in upcoming rulemakings regarding how much access to grant to financial 
+institutions, which could help them conduct customer due diligence. 
+
+In a March 2, 2022, letter to Secretary of the Treasury Janet Yellen and FinCEN Acting Director 
+Das, Ranking House Financial Services Committee Member Patrick McHenry and Ranking 
+House Committee on Small Business Member Blaine Luetkemeyer cautioned against efforts to 
+expand the CTA’s mandate.109 The status of CTA implementation—including how much access to 
+beneficial ownership data will be allowed under future FinCEN rulemaking—remained a major 
+issue of debate during the April 2022 House Financial Services Committee hearing.110 Although 
+some Members lauded the progress FinCEN has been able to make to date toward establishing 
+the beneficial ownership registry and other AMLA requirements, others criticized the ongoing 
+rulemaking process.111 
+
+ Law Enforcement Implications for AMLA Implementation 
+ AMLA provides U.S. law enforcement with several potentially powerful tools for combating 
+money laundering. Various observers have commented on the potential for several such 
+provisions to improve U.S. enforcement of BSA violations, including provisions to increase BSA 
+penalties, strengthen whistleblower incentives, combat corruption, and expand subpoena powers 
+for obtaining foreign bank records.112 As AMLA implementation continues, more observers, as 
+well as Members of Congress, may focus on questions related to how AMLA is improving U.S. 
+efforts to investigate and prosecute financial crimes in practice . The practical effect of AMLA 
+provisions on law enforcement outcomes has implications for the success of other U.S. policy 
+initiatives, including counternarcotics.113 
+
+As enacted, AMLA directs the Attorney General to play a key consultative role in the 
+implementation of many of its provisions and requires the Attorney General to prepare certain 
+reports—although not all such reports are required to be submitted to Congress. One annual 
+reporting requirement, for example, requires the Attorney General to report to the Secretary of the 
+
+ 
+109 Letter from Representatives Patrick McHenry, Ranking Member of the House Committee on Financial Services, and 
+Blaine Luetkemeyer, Ranking Member of the House Committee on Small Business, to Secretary of the Treasury Janet 
+Yellen and Acting FinCEN Director Him Das, March 2, 2022. 
+
+110 See, for example, questioning by Ranking Member Rep. Patrick McHenry in CQ transcripts, House Financial 
+Services Committee Holds Hearing on Financial Crimes Enforcement Network , April 28, 2022. 
+
+111 Ibid. 
+112 See, for example, Gibson Dunn, “The Top 10 Takeaways for Financial Institutions from the Anti-Money 
+Laundering Act of 2020,” Client Alert, January 1, 2021, https://www.gibsondunn.com/the-top-10-takeaways-for-
+financial-institutions-from-the-anti-money-laundering-act-of-2020/; and Matthew Stephenson, “It’s Not Just the 
+Corporate Transparency Act: Other Reasons to Welcome the Passage of the U.S. NDAA,” The Global Anticorruption 
+Blog, January 12, 2021, https://globalanticorruptionblog.com/2021/01/12/its-not-just-the-corporate-transparency-act-
+other-reasons-to-welcome-the-passage-of-the-u-s-ndaa/. 
+
+113 The Performance Review System Report, a component of the Biden Administration’s 2022 National Drug Control 
+Strategy (as required by 21 U.S.C. §1705), for example, acknowledges that “a single source database that can track 
+whole-of-government efforts against the illicit finance activities of the TCOs or their enablers” does not currently exist; 
+however, efforts “to track all enforcement action and prosecutorial outcomes against the full FinCEN dataset” are 
+underway in response to AMLA’s requirement for a more robust feedback mechanism between regulatory, national 
+security, law enforcement, and financial industry partners on illicit finance risks and priorities. White House, Executive 
+Office of the President, Office of National Drug Control Policy, National Drug Control Strategy Performance Review 
+System Report , April 2022, pp. 32-33. 
+
+Congressional Research Service 
+
+ 
+
+22 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+Treasury on law enforcement use of BSA financial intelligence data (§6201). Congress may seek 
+further information directly from the Department of Justice and other federal agencies to evaluate 
+the measurable impact of AMLA’s implementation in terms of law enforcement outcomes in 
+prosecuting money laundering and other BSA violations, as amended or added by AMLA. 
+
+ Selected Legislation in the 117th Congress 
+ In addition to AMLA implementation, there is congressional interest in further amending the U.S. 
+AML/CFT framework through legislation. While such congressional activity reflects the ongoing 
+view of some observers that the U.S. AML/CFT regime requires further improvement, others may 
+caution that enactment of additional measures could further challenge FinCEN’s ability to 
+implement AMLA and achieve other strategic objectives. 
+
+The House-passed National Defense Authorization Act for Fiscal Year 2023 (H.R. 7900; FY2023 
+NDAA), for example, includes provisions on financial services matters (Title LIV, §§5401-5475). 
+Included in the House-passed FY2023 NDAA is the Establishing New Authorities for Businesses 
+Laundering and Enabling Risks to Securities Act (ENABLERS Act; see also H.R. 5525), which, 
+among other provisions, seeks to subject certain non-bank professional service providers 
+(“gatekeepers”) to AML/CFT compliance requirements. Section 5415 of the House-passed 
+FY2023 NDAA would also amend and expand FinCEN’s authority to apply a new special 
+measure prohibiting or setting conditions on certain transmittals of funds involving a foreign 
+jurisdiction or financial institution “of primary money laundering concern” (see also H.R. 7128, 
+Special Measures to Fight Modern Threats Act).114 
+
+Potentially reflecting a desire for increased congressional oversight and accountability on 
+AML/CFT matters and FinCEN’s role, the Financial Crimes Enforcement Network 
+Improvements Act (H.R. 7623), among other provisions, seeks to require the President to appoint 
+the FinCEN Director and the Senate to confirm the appointment. Other bills in the 117th 
+Congress, which, if enacted, could affect FinCEN, the BSA, and/or AML/CFT policy 
+implementation include the: Timely Delivery of Bank Secrecy Act Reports Act (H.R. 7734, which 
+passed the House); FinCEN Exam Delegation Study (H.R. 6328); Financial Crimes Enforcement 
+Network Exchange Improvement Act (H.R. 5320); Nowhere to Hide Oligarchs’ Assets Act (H.R. 
+7080); Protecting Financial Privacy Act of 2021 (H.R. 5451); Digital Asset Market Structure and 
+Investor Protection Act (H.R. 4741); and Gun Violence Prevention Through Financial Intelligence 
+Act (H.R. 5764 and S. 3117). 
+
+ 
+
+ 
+
+ 
+
+ Author Information 
+
+ 
+Liana W. Rosen 
+
+ Rena S. Miller 
+
+Specialist in International Crime and Narcotics 
+
+Specialist in Financial Economics 
+
+ 
+
+ 
+
+ 
+114 The current authority to apply special measures is codified at 31 U.S.C. §5318A. 
+
+Congressional Research Service 
+
+ 
+
+23 
+
+ 
+ FinCEN: AMLA Implementation and Beyond 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan 
+shared staff to congressional committees and Members of Congress. It operates solely at the behest of and 
+under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other 
+than public understanding of information that has been provided by CRS to Members of Congress in 
+connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not 
+subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in 
+its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or 
+material from a third party, you may need to obtain the permission of the copyright holder if you wish to 
+copy or otherwise use copyrighted material. 
+
+ 
+
+Congressional Research Service 
+
+R47255 · VERSION 1 · NEW 
+
+24
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+Order Code RS21125
+
+Updated December 21, 2006
+
+ Homeland Security: Coast Guard Operations 
+
+ — Background and Issues for Congress 
+
+Ronald O’Rourke
+
+Specialist in National Defense
+
+Foreign Affairs, Defense, and Trade Division
+
+ Summary 
+
+The Coast Guard is the lead federal agency for maritime homeland security. For
+
+FY2007, the Coast Guard requested a total of about $4.5 billion for missions defined in
+The Homeland Security Act of 2002 (P.L. 107-296) as the Coast Guard’s homeland
+security missions. The Coast Guard’s homeland security operations pose several
+potential issues for Congress. This report will be updated as events warrant.
+
+ Background 
+
+ The Coast Guard’s Role in Homeland Security. The Coast Guard, which is
+
+a part of the Department of Homeland Security (DHS), is the lead federal agency for
+maritime homeland security. Section 888(a)(2) of The Homeland Security Act of 2002
+(P.L. 107-296 of November 25, 2002), which established DHS, specifies five homeland
+security missions for the Coast Guard: (1) ports, waterways, and coastal security, (2) drug
+interdiction, (3) migrant interdiction, (4) defense readiness, and (5) other law
+enforcement.1 The Coast Guard, in its proposed FY2007 budget, excludes drug
+interdiction and other law enforcement from its definition of its homeland security
+missions.2
+
+Under the Ports and Waterways Safety Act of 1972 (P.L. 92-340) and the Maritime
+
+Transportation Security Act (MTSA) of 2002 (P.L. 107-295 of November 25, 2002), the
+Coast Guard has responsibility to protect vessels and harbors from subversive acts.3 With
+
+1 Section 888(a)(1) defines the Coast Guard’s non-homeland security missions as (1) marine
+safety, (2) search and rescue, (3) aids to navigation, (4) living marine resources (fisheries law
+enforcement), (5) marine environmental protection, and (6) ice operations.
+
+2 U.S. Department of Homeland Security, U.S. Coast Guard [FY]2007 Budget in Brief .
+Washington, 2006. (February 2006) Table 1 on p. B-2.
+
+3 For more on port security, see CRS Report RL31733, Port and Maritime Security: Background 
+
+(continued...)
+
+ 
+ CRS-2
+
+regard to port security, the Coast Guard is responsible for evaluating, boarding, and
+inspecting commercial ships approaching U.S. waters, countering terrorist threats in U.S.
+ports, and helping protect U.S. Navy ships in U.S. ports. A Coast Guard officer in each
+port area is the Captain of the Port (COTP), who is the lead federal official for security
+and safety of vessels and waterways in that area.
+
+ Homeland Security Missions In The Coast Guard Budget. Table 1 below
+
+shows FY2005-FY2007 funding for the Coast Guard’s homeland security and non-
+homeland security missions.
+
+ Table 1. FY2005-FY2007 Funding For Homeland Security Missions 
+
+(FY2005 actual, FY2006 enacted, FY2007 requested; homeland security missions as
+
+defined in Section 888(a)(2) of Homeland Security Act of 2002 [P.L. 107-296])
+
+ PWCSa 
+
+ Drug 
+
+ Migrant 
+
+ Defense 
+
+ Other law 
+
+ Total 
+
+ interdictionb 
+
+ interdiction 
+
+ readiness 
+
+ enforcementb 
+
+ Funding amounts (millions of dollars, rounded to nearest million) 
+
+ FY05 
+
+1,625
+
+1,017
+
+549
+
+613
+
+ 95
+
+3,899
+
+ FY06 
+
+1,735
+
+1,211
+
+462
+
+616
+
+144
+
+4,168
+
+ FY07 
+
+2,035
+
+1,239
+
+487
+
+603
+
+153
+
+4,516
+
+ Percent of total Coast Guard budget 
+
+ FY05 
+
+21.0
+
+13.2
+
+7.1
+
+7.9
+
+1.2
+
+50.4
+
+ FY06 
+
+20.9
+
+14.6
+
+5.6
+
+7.4
+
+1.7
+
+50.2
+
+ FY07 
+
+24.2
+
+14.7
+
+5.8
+
+7.2
+
+1.8
+
+53.6
+
+ Source: Prepared by CRS using data from U.S. Department of Homeland Security, U.S. Coast
+Guard [FY]2007 Budget in Brief . Washington, 2006. (February 2006) Table 1 on p. B-2.
+Figures may not add due to rounding. 
+a. Ports, waterways, and coastal security
+b. The Coast Guard, in its proposed FY2007 budget, excludes drug interdiction and other law
+enforcement from its definition of its homeland security missions.
+
+ Issues for Congress 
+
+Potential issues for Congress concerning the Coast Guard’s homeland security
+
+operations include, among others, the following:
+
+! the sufficiency of Coast Guard funding, assets, and personnel levels for
+
+performing both homeland and non-homeland security missions;
+
+! the division of the Coast Guard’s budget between homeland security and
+
+non-homeland security missions;
+
+! whether the Coast Guard is achieving sufficient interoperability and
+
+coordination with other DHS, federal, state, and local authorities
+involved in the maritime aspects of homeland security, including
+coordination of operations and coordination and sharing of intelligence;
+
+! monitoring compliance with the facility and vessel security plans that the
+
+Coast Guard has reviewed and approved;
+
+3 (...continued)
+ and Issues for Congress , by John F. Frittelli.
+
+ 
+ CRS-3
+
+! how the Coast guard assesses security risks to various ports and
+
+prioritizes these risks for allocating port-security funding;
+
+! completing foreign port security assessments;
+! implementing a long-range vessel-tracking system required by MTSA;
+! implementing AIS;
+! inland waterway security; and
+! response plans for maritime security incidents.
+
+A December 2006 report from the DHS Inspector General on major DHS
+
+management challenges stated:
+
+To implement the Maritime Transportation Security Act of 2002 in a timely and
+
+effective manner, USCG must balance the resources devoted to the performance of
+homeland and non-homeland security missions; improve the performance of its
+homeland security missions; maintain and re-capitalize USCG’s Deepwater fleet of
+aircraft, cutters, and small boats; restore the readiness of small boat stations to
+perform their search and rescue missions; and increase the number and quality of
+resource hours devoted to non-homeland security missions. For example, while
+overall resource hours devoted to USCG’s homeland security missions grew steadily
+from FY 2001 through FY 2005, USCG continues to experience difficulty meeting its
+performance goals for homeland security missions.4
+
+A July 2006 report from the DHS Inspector General on Coast Guard mission
+
+performance in FY2005 stated:
+
+Since FY 2001, more [Coast Guard] resource hours have been dedicated to homeland
+security missions than for non-homeland security missions. However, after an initial
+drop in FY 2002, non-homeland security resource hours have increased every period,
+and have now returned to within 3% of baseline levels.... The Coast Guard has been
+more successful in meeting goals for its traditional non-homeland security missions,
+meeting 22 of 28 goals (79%) where measurable goals and results existed, but still
+leaving room for improved performance. Not including the Ports, Waterways, and
+Coastal Security mission, by far the largest user of resource hours of any Coast Guard
+mission, the Coast Guard achieved only 26% of its homeland security goals (5 of
+19).... Growth in total resource hours has leveled off. Since resource hours are based
+on the limited and finite number of available assets, the Coast Guard will be unable
+to increase total resource hours without the acquisition of additional aircraft, cutters,
+and boats. Consequently, the Coast Guard has a limited ability to respond to an
+extended crisis, and therefore must divert resources normally dedicated to other
+missions. To improve performance within their overall constraints, the Coast Guard
+must ensure that a comprehensive and fully defined performance management system
+is implemented, and that experienced and trained personnel are available to satisfy
+increased workload demands.5
+
+In March 2005, the Government Accountability Office (GAO) testified that:
+
+4 U.S. Department of Homeland Security, Office of Inspector General, Major Management
+Challenges Facing the Department of Homeland Security (Excerpts from the FY 2006 DHS
+Performance and Accountability Report) , December 2006. (OIG-07-12) p. 21.
+
+5 U.S. Department of Homeland Security, Office of Inspector General, Annual Review of Mission
+Performance, Untied States Coast Guard (FY 2005) , July 2006. (OIG-06-50) p. 1.
+
+ 
+ CRS-4
+
+The Maritime Transportation Security Act of 2002 charged the Coast Guard with
+many maritime homeland security responsibilities, such as assessing port
+vulnerabilities and ensuring that vessels and port facilities have adequate security
+plans, and the Coast Guard has worked hard to meet these requirements. GAO’s
+reviews of these efforts have disclosed some areas for attention as well, such as
+developing ways to ensure that security plans are carried out with vigilance. The
+Coast Guard has taken steps to deal with some of these areas, but opportunities for
+improvement remain.6
+
+ Legislative Activity in 2006 
+
+ H.R. 889/P.L. 109-241 (Coast Guard and Maritime Transportation Act of 
+
+ 2006). Section 102 of the conference report (H.Rept. 109-413 of April 6, 2006) on H.R.
+889 (P.L. 109-241 of July 12, 2006) authorizes an active-duty end strength of 45,500 for
+the Coast Guard for FY2006. Section 201 extends the Coast Guard’s vessel and
+anchorage movement authority to U.S. territorial waters out to 12 nautical miles from
+shore. Section 202 permits the Coast to provide technical assistance (including law
+enforcement and maritime safety and security training) to foreign navies, coast guards,
+and other maritime authorities. Section 206 expands the Coast Guard’s reserve recall
+authority. Section 211 inserts a new phrase into 14 USC 3 so that it reads as follows
+(with the inserted phrase noted in italics): “Upon the declaration of war if Congress so
+directs in the declaration or when the President directs, the Coast Guard shall operate as
+a service in the Navy, and shall so continue until the President, by Executive order,
+transfers the Coast Guard back to the Department of Homeland Security.” Section 213
+ requires the Coast Guard to report on “opportunities for cost savings and operational
+efficiencies that can be achieved through and the feasibility of colocating Coast Guard
+assets and personnel at facilities of other armed forces throughout the United States.”
+
+ Section 305 amends 46 USC 70106 to permit Coast Guard maritime safety and
+
+security teams to be used for any Coast Guard mission. Section 309 requires the
+Secretary of the department in which the Coast Guard is operating to establish a review
+process before administration law judges to consider an appeal of a denial of an
+application for a transportation security card. Section 404 directs the Coast Guard to
+conduct a three-year pilot program for a long-range vessel tracking system, subject to the
+availability of appropriations. Section 406 requires the Coast Guard to review and report
+on the adequacy of Coast Guard assets and facilities at certain locations for performing
+the Coast Guard’s missions, and to review and report on the adequacy of Coast Guard end
+strength for performing the Coast Guard’s missions. Section 411 requires a report on the
+availability and effectiveness of software information technology systems for port
+security, the data evaluated by such systems, and the costs associated with implementing
+such technology at all Sector Command Centers, Joint Harbor Operations Centers, and
+strategic defense and energy dependent ports. Section 419 authorizes a competitive grant
+to design, develop, and prototype a device that integrates a Class B Automatic
+Identification System (AIS) transponder with an Federal Communications Commission
+(FCC)-approved wireless maritime data device. The section also expresses the sense of
+
+6 Government Accountability Office, COAST GUARD[:] Observations on Agency Priorities in
+Fiscal Year 2006 Budget Request , GAO-05-364T, Mar. 17, 2005.
+
+ 
+ CRS-5
+
+the Senate that the FCC should quickly resolve the disposition of its rulemaking on the
+AIS and licensee use of AIS frequency bands.
+
+ H.R. 5681 (Coast Guard Authorization Act of 2006). As reported by the
+
+ House Transportation and Infrastructure Committee (H.Rept. 109-614 of July 28,
+2006), Section 102 authorizes an active-duty end strength of 45,500 for the Coast Guard
+for FY2007. Section 212 amends section 2 of title 14, United States Code, to direct the
+Coast Guard to enforce regulations ensuring the maritime safety of nuclear power
+facilities located adjacent to navigable waters of the United States not specifically
+delegated by law to some other executive department. H.Rept. 109-614 states:
+
+Following the events of September 11th, the Coast Guard has been designated as the
+lead Federal agency with responsibilities for maritime homeland security. The Coast
+Guard has quickly incorporated these new missions with the Service's many
+traditional missions of search and rescue, illegal drug and migrant interdiction,
+icebreaking operations, oil spill response and prevention, maritime safety, marine
+environmental protection, and fisheries law enforcement. However, the addition of
+these new mission demands in combination with the Service's rapidly deteriorating
+fleet of vessels and aircraft is severely testing the Coast Guard's capabilities to carry
+out its many important missions....
+
+The Committee will also continue to oversee the Coast Guard to ensure that the
+
+Service is achieving a balance between its traditional and homeland security
+missions.... It is imperative that the Service's non-homeland security functions remain
+priorities for the Coast Guard.... As a result of concerns that the service will not have
+the funding it needs for traditional missions, the Committee has placed a ‘floor’ on
+funding that will be used for marine safety programs and search and rescue. 
+
+The Committee continues to oppose the Administration's request to transfer a portion
+of the Coast Guard's Research, Development, Training and Evaluation (‘RDT&E’)
+funds from the Coast Guard budget to the Science and Technology Directorate of the
+Department of Homeland Security. The Administration proposed to fund the Coast
+Guard's Research and Development Center and the Service's non-homeland security
+research projects within the Service's budget; however, the funding for the Coast
+Guard's homeland security research programs has again been transferred to the
+Science and Technology Directorate with the Department of Homeland Security.
+Under Section 888 of the Homeland Security Act, the Coast Guard is to remain intact
+with all authorities, functions, and capabilities remaining under the authority of the
+Service. The Administration's proposal to remove RDT&E from the Coast Guard's
+control would violate Section 888. The Committee will continue to take steps to
+maintain the integrity of the Coast Guard as an independent entity within the
+Department. 
+
+The Committee is also concerned by the Coast Guard's lack of research and
+
+development programs to enhance the service's capabilities to carry its traditional
+missions. The Coast Guard's non-homeland security research and development budget
+has consistently decreased over the last five-year period; however the need to improve
+the Coast Guard's search and rescue, oil spill response and prevention, drug
+interdiction and maritime domain awareness missions has not decreased. The
+Administration has requested only $900,000 for non-homeland security research and
+development programs for fiscal year 2007. The Committee recommends that the
+Coast Guard continue to carry out a robust research and development program to
+
+ 
+ CRS-6
+
+support each of its many missions and to continue to develop new technologies and
+procedures to ensure the security and safety of lives and property at sea.
+
+ H.R. 5441/P.L. 109-295 (FY2007 DHS Appropriations Act). The House and
+
+Senate reports on H.R. 5441 recommended various changes to requested funding amounts
+for the Coast Guard, including items related to the Coast Guard’s homeland security
+missions. The House report (H.Rept. 109-476 of May 22, 2006) stated:
+
+The Committee recommends $15,000,000 [for the Coast Guard] for port security
+inspections, $15,000,000 above the President's budget request. Funding shall be
+allocated to two activities. First, this funding shall be used to double the amount of
+foreign port assessments, as required by MTSA. The Committee anticipates that, with
+these additional funds, the Coast Guard will be able to reduce the amount of time it
+will take to complete all foreign port assessments by half. Second, the funding will
+permit the Coast Guard to conduct unannounced inspections of domestic port facilities
+to ensure that they are maintaining agreed upon security levels. This funding is
+provided to strengthen the Department's overall port, container, and cargo security
+initiatives.... Currently, the Coast Guard does not gather complete ownership
+information as part of its facility and vessel security plans. The Committee directs the
+Coast Guard to amend these plans so that it may gather ownership information in
+addition to information about the immediate entity running the facility or vessel.
+
+The Senate report (S.Rept. 109-273 of June 29, 2006) stated:
+
+The Committee notes [DHS’s] change in policy regarding the homeland security
+designation of the Coast Guard's drug interdiction mission. In previous budget
+submissions, the drug interdiction mission was considered to be a homeland security
+function. In the fiscal year 2007 budget submission, the administration classifies the
+mission as non-homeland security. The Committee challenges the logic behind this
+change in policy given recent intelligence which claims ties exist between terrorist
+financing and the illegal drug trade. The Committee does not concur with this change
+in policy and encourages the administration to re-visit this decision in the fiscal year
+2008 budget request.
+
+The report also states that “The Committee disagrees with the President's budget proposal
+to transfer a portion of the funding for Coast Guard research and development to the
+Science and Technology ‘Research, Development, Acquisition, and Operations’ account.”
+
+ The conference report (H.Rept. 109-699 of September 28, 2006) states that it fully
+
+funds the Coast Guard’s Operating Expenses (OE) account, “except $5,986,000 is reduced
+from centrally managed accounts due to high unobligated balances and no funding is
+provided for the new Coast Guard headquarters at the St. Elizabeths campus. In addition,
+the conferees include $15,000,000 for port security inspections to double the amount of
+foreign port assessments, to conduct unannounced inspections of domestic port facilities,
+and for additional port vulnerability and threat assessments, if necessary.” (Page 142)
+The report also “direct[s the] Coast Guard to continue submitting quarterly mission hour
+emphasis and acquisition reports to the Committees on Appropriations consistent with the
+deadlines articulated under section 360 of Division I of Public Law 108-7.” (Page 144)
\ No newline at end of file
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@@ -0,0 +1,1272 @@
+The Strategic Petroleum Reserve: Authorization, Operation, and Drawdown Policy
+
+ August 27, 2013
+ (R42460)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ Introduction 
+
+ Background─Creating the SPR 
+
+ International Energy Agency Obligation 
+
+ SPR Drawdown Authorities 
+
+ Severe Energy Supply Interruption Emergencies 
+
+ Severe Domestic Energy Supply Interruption 
+
+ Test Sale 
+
+ SPR Sites 
+
+ Bryan Mound 
+
+ Big Hill 
+
+ West Hackberry 
+
+ Bayou Choctaw 
+
+ SPR Capacity 
+
+ SPR Releases 
+
+ 1990-1991 Severe Energy Supply Interruption─Desert Storm Desert Shield 
+
+ 2005 Severe Domestic Energy Supply Interruptions─Hurricanes Katrina and Rita 
+
+ 2011 IEA Coordinate Release in Response to Libyan Crude Oil Curtailment 
+
+ Other Policy Considerations 
+
+ Refining Capacity vs. Crude Supply 
+
+ Gasoline Price Increases 
+
+ The Future of U.S. Imports of Crude Oil 
+
+ Proposals in the 113 th Congress (1 st Half) 
+
+ 
+ 
+ Figures
+
+ 
+ Figure 1. Strategic Petroleum Reserve 
+
+ 
+ 
+
+ 
+ Tables
+
+ 
+ Table 1. Strategic Petroleum Reserve Inventory as of 2012 
+
+ Table 2. Strategic Petroleum Reserve History of Crude Oil Releases Summary 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ Congress authorized the Strategic Petroleum Reserve (SPR) in the Energy Policy and Conservation Act (EPCA) of 1975 to help prevent a repetition of the economic disruption caused by the 1973-1974 Arab oil embargo. EPCA specifically authorizes the President to draw down the SPR upon a finding that there is a "severe energy supply interruption." The meaning of a "severe energy supply interruption" has been controversial. The authors of EPCA intended the SPR only to ameliorate discernible physical shortages of crude oil. Historically, increasing crude oil prices typically signal market concerns for supply availability. However, Congress deliberately kept price trigger considerations out of the President's SPR drawdown authority because of the question about what price level should trigger a drawdown, and the concern that a price threshold could influence market behavior and industry inventory practices. As a member of the International Energy Agency—a coalition of 28 countries—the United States agrees to support energy supply security through energy policy cooperation, commit to maintaining emergency reserves equal to 90 days of net petroleum oil imports, develop programs for demand restraint in the event of emergencies, and participate in allocation of oil deliveries among the signatory nations to balance a shortage. 
+
+ The Department of Energy (DOE) manages the SPR, which is comprised of 62 underground storage caverns that were solution-mined from naturally occurring salt domes located at four sites in Texas and Louisiana. The 2005 Energy Policy Act directed SPR expansion to its authorized capacity of 1 billion barrels, but the SPR's physical expansion has not proceeded beyond 727 million barrels. The SPR's maximum drawdown capability is 4.4 million barrels per day, based on the capacity of the pipelines and marine terminals that serve it. Legislation restricts SPR sales to no more than 30 million barrels over a 60-day period for anything less than a severe energy supply interruption.
+
+ Congress initially appropriated funds to fill the SPR through crude oil purchases, but ended that practice in 1994. In 2000, the Department of Energy began acquiring oil to fill the SPR through the royalty-in-kind (RIK) program. In lieu of paying cash royalties on Gulf of Mexico leases, producers diverted a portion of their production volume to the SPR. The Secretary of the Interior administratively terminated the RIK program in 2009. 
+
+ The DOE has conducted sales and loans of crude oil from the SPR for several different reasons. The 1990 Energy Policy and Conservation Act Amendments expanded SPR drawdown authority to include responding to short-term supply interruptions stemming from situations internal to the United States. U.S. Presidents have authorized emergency sales of SPR crude to meet IEA obligations during the 1990 Persian Gulf War, in the aftermath of Hurricanes Katrina and Rita in 2005, and after a prolonged disruption of Libyan crude in 2011. In addition to these emergency sales, the Department of Energy has released oil, from time-to-time, to test the SPR system, make loans to help refiners bridge temporary supply disruptions, and sold oil at the direction of Congress to generate revenue for budget deficit reduction.
+
+ The 30.64 million barrel SPR sale in 2011 reduced the SPR's inventory from 726.6 million barrels to 695.9 million barrels. The SPR currently holds the equivalent of 80 days of import protection (based on 2012 data of 8.72 million barrels per day of net petroleum imports).
+
+ 
+ 
+ The Strategic Petroleum Reserve: Authorization, Operation, and Drawdown Policy
+
+ 
+ Introduction
+
+ As internal conflicts in Egypt and Syria escalate, and the United States weighs options to act militarily in response to the likely use of chemical weapons, Iran may threaten to reprise its previous threat to block the Strait of Hormuz. 1 About 17 million barrels per day (MMb/d) of oil passed through the Strait in 2011, which was roughly 20% of the global oil market and 35% of seaborne trade. 2 
+
+ An attendant rise in crude oil prices could once again led to calls for releasing oil from the Strategic Petroleum Reserve (SPR). Despite the recent rising prices and the rising, markets have not experienced supply shortages. Considerable new crude oil production capacity has come online, and adequate excess capacity exists worldwide, particularly in Saudi Arabia. However, the fear is that excess capacity may not be adequate to make up losses from a blockade, an event that U.S. Navy would not tolerate. 3 
+
+ New resource development in Texas (Eagle Ford Formation), North Dakota (Bakken Formation), and Ohio (Utica Formation) has added significantly to U.S. light crude oil production. Until the last quarter of 2012, the United States had experienced a drop in crude oil demand, and now faces the prospect of exporting its excess light crude oil production. The United States has already increased its exports of refined products. 
+
+ Nearly half of the U.S. refineries (some 115) process heavy crude oils. Moreover, these refineries account for roughly 75% of refining capacity. 4 Should the prospect of releasing SPR oil arise, the question may be as much about whether to sell heavy or light as how much. In 2011, President Obama ordered a sale of 30 million barrels of light sweet crude oil to offset a curtailment in Libya's production when NATO forces intervened militarily in that country's internal conflict. The oil sale had short-term influence on global crude oil prices, but a limited (if any) influence on long-term prices.
+
+ Background─Creating the SPR
+
+ From the mid-1970s through the present day, the United States has had to absorb a number of significant spikes in the price of crude oil and petroleum products. 5 Whether driven by disruptions in the physical supply of crude or refined fuels, unexpected demand growth, or by uncertainties owing to international conflicts and instabilities, these price increases have consequences for the United States. Elevated petroleum prices affect the balance of trade and siphon away disposable income that might support local economies, investment, or savings.
+
+ The SPR came about because of the 1973 Arab-Israeli War. In reaction to the United States' support for Israel, the Organization of Arab Petroleum Exporting Countries (OAPEC) imposed an oil embargo on the United States, the Netherlands, and Canada, and reduced production. While some Arab crude did reach the United States, the price of imported crude oil rose from roughly $4/barrel (bbl) during the last quarter of 1973 to an average price of $12.50/bbl in 1974. 
+
+ In response to the 1973 oil embargo, Congress created a Strategic Petroleum Reserve of up to 1 billion barrels in the Energy Policy and Conservation Act (EPCA) of 1975. 6 The SPR was meant to contain enough crude oil to replace net imports for 90 days, with a requirement initially to store 150 million barrels. In May 1978, Congress authorized expansion of the SPR's physical capacity to 750 million barrels, and in 2005 directed further expansion to the authorized size of 1 billion barrels. 7 The George W. Bush Administration unsuccessfully attempted to persuade Congress of the need to expand the SPR to 1.5 billion barrels.
+
+ Congress intended the SPR to help prevent a repetition of the economic disruption that the 1973 Arab oil embargo had caused. While no amount of strategic stocks can insulate an oil-consuming nation from paying the market price for oil in a supply emergency, the availability of strategic stocks can help mitigate the magnitude of the market's reaction to a crisis. One of the original perceptions of a strategic stockpile's value was that it would discourage the use of oil as a political weapon. OAPEC intended to create a physical supply disruption with their embargo. Congress's motivation in creating the SPR focused especially on a deliberate and dramatic physical oil supply disruption and on mitigating the significant economic impacts of a shortage stemming from international events. In the event of a supply interruption, proponents reasoned that introducing oil into the U.S. market from the SPR would offset the lost supply and in doing so help calm markets, mitigate sharp price spikes, and reduce economic disruptions (i.e., gross domestic product loss). The SPR would also buy time for the crisis to sort itself out or for diplomacy to seek some resolution before a potentially severe oil shortage escalated the crisis.
+
+ International Energy Agency Obligation
+
+ The Arab oil embargo also fostered the establishment of the International Energy Agency (IEA) to develop plans and measures for emergency responses to energy crises. Strategic stocks are one of the policies included in the agency's International Energy Program (IEP). IEA member countries, including the United States, are committed to maintaining oil stocks (inventories) equivalent to 90 days of their prior year's net imports, developing programs for demand restraint in the event of emergencies, and agreeing to participate in allocation of oil deliveries to balance a shortage among IEA members. 8 In 2011, the United States participated in a coordinated IEA drawdown in response to the shutdown of Libyan oil exports. (See below.) At its current inventory of 696 million barrels, the SPR provides the United States roughly 80 days of net import protection and meets the 90-day IEA obligation though the inclusion of industry-held oil stocks. At the full drawdown rate of 4.4 MMb/d, the SPR can deliver crude oil for 90 days, dropping to a rate of 3.8 MMb/d for an additional 30 days, and dropping further in drawdown rate for up to 180 days as stocks deplete. 9 These measures of days of protection assume a total curtailment of oil supply to importing nations, a scenario that is highly unlikely. This would be especially true for the United States, given that Canada is currently the nation's largest foreign source for crude oil.
+
+ Some IEA member nations require a certain level of stock holding by the private sector or by both the public and private sectors. The private oil sector holds roughly 60% of IEA stocks, whereas governments and supervisory agencies hold the remaining 40%. 10 (The U.S. federal government holds 100% of the SPR stock.)
+
+ SPR Drawdown Authorities
+
+ Presidential authority to authorize a drawdown depends on making the determination that a severe supply interruption exists nationally or internationally, or is imminent. The United States is obligated to join in an IEA coordinated response. In the case of an international interruption, the President may release an unlimited volume of crude oil. In the case of a national interruption, some statutory limitations apply. The Secretary of Energy also has limited authority to release crude oil for a test drawdown.
+
+ Severe Energy Supply Interruption Emergencies
+
+ The Energy Policy and Conservation Act (EPCA, P.L. 94-163 ) authorized drawdown of the Reserve upon a finding by the President that there is a "severe energy supply interruption." By the statute, such an interruption exists when the President determines that
+ 1. an emergency situation exists and there is a significant reduction in supply which is of significant scope and duration;
+
+ 2. a severe increase in the price of petroleum products has resulted from such emergency situation; and
+
+ 3. a price increase is likely to cause a major adverse impact on the national economy. 11 
+ Severe Domestic Energy Supply Interruption
+
+ Congress enacted additional drawdown authority in the 1990 Energy Policy and Conservation Act Amendments ( P.L. 101-383 ) after the Exxon Valdez oil spill, which interrupted the shipment of Alaskan oil, triggering spot shortages and price increases. The intention was to provide for an SPR drawdown under a less rigorous determination than EPCA mandated. This provision authorized the President to use the SPR for domestic energy supply shortages without having to declare a "severe energy supply interruption" or the need to meet obligations of the United States under the international energy program. 12 
+
+ Under the additional authorities in P.L. 101-383 , the President can initiate a drawdown in the event of a circumstance that "constitutes, or is likely to become, a domestic or international energy supply shortage of significant scope or duration" and where "action taken ... would assist directly and significantly in preventing or reducing the adverse impact of such shortage." This authority limits SPR sales to no more than 30 million barrels over a maximum 60-day period only when the SPR inventory is above 500 million barrels.
+
+ Test Sale
+
+ By law, the Secretary of Energy must periodically evaluate SPR drawdown and sale procedures, and carry out a test drawdown and sale, or exchange of petroleum products from the reserve, up to 5 million barrels. 13 
+
+ SPR Sites
+
+ The SPR physically comprises four sites, two in Texas and two in Louisiana ( Figure 1 ). The sites offer access to both marine terminals and pipeline systems needed for moving crude oil to and from the SPR. Each site consists of an underground salt dome (a naturally occurring geologic structure), solution-mined to create storage caverns. Stored crude oil is removed by injecting water to displace the oil. The cavern remains structurally intact as long as the stored oil remains in place. In the event of multiple sales or exchanges over time, repeated water injections will cause salt leaching and begin to compromise the structural integrity of the caverns. 14 
+
+ The SPR's storage capacity had expanded to 727 million barrels, and its inventory had reached nearly 700 million barrels before Hurricanes Katrina and Rita in 2005. Following the storms, DOE loaned some crude oil to refiners and sold some through competitive bidding. Borrowers of SPR oil are required to repay their loans "in-kind" with a premium, essentially returning a larger amount of oil than borrowed. 15 The SPR reached its maximum fill of 727 million barrels by 2010 (through royalty-in-kind acquisition) and remained at that level until the 2011 drawdown reduced the inventory to 695 million barrels. 16 The SPR currently holds the equivalent of 80 days of import protection (based on 2012 import data of 8.72 million barrels per day of net petroleum imports). Table 1 shows the current SPR inventory level, accounting for the 30 million barrels sold in the summer of 2011. 
+
+ 
+ 
+ 
+ 
+ 
+ Figure 1. Strategic Petroleum Reserve
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: DOE Strategic petroleum Reserve Annual Report for Calendar Year 2010.
+
+ 
+ 
+ 
+ 
+
+ 
+ 
+ Table 1. Strategic Petroleum Reserve Inventory as of 2012
+
+ (million barrels)
+
+ 
+
+ 
+ 
+ 
+ Site 
+
+ 
+ 
+ Sweet a 
+
+ 
+ 
+ Sour b 
+
+ 
+ 
+ Total c 
+
+ 
+ 
+ 
+ 
+ Bryan Mound, Brazoria County, Texas
+
+ 
+ 
+ 67.5
+
+ 
+ 
+ 176.4
+
+ 
+ 
+ 253.9
+
+ 
+ 
+ 
+ 
+ Big Hill, Jefferson County, Texas
+
+ 
+ 
+ 62.8
+
+ 
+ 
+ 97.4
+
+ 
+ 
+ 170.2
+
+ 
+ 
+ 
+ 
+ West Hackberry, Cameron Parish, Louisiana
+
+ 
+ 
+ 109.7
+
+ 
+ 
+ 108.0
+
+ 
+ 
+ 227.8
+
+ 
+ 
+ 
+ 
+ Bayou Choctaw, Iberville Parish, Louisiana
+
+ 
+ 
+ 21.7
+
+ 
+ 
+ 51.8
+
+ 
+ 
+ 73.6
+
+ 
+ 
+ 
+ 
+ Subtotal Underground Inventory
+
+ 
+ 
+ 261.8
+
+ 
+ 
+ 433.5
+
+ 
+ 
+ 725.4
+
+ 
+ 
+ 
+ 
+ Tanks and Pipelines
+
+ 
+ 
+ 0.7
+
+ 
+ 
+ 0.4
+
+ 
+ 
+ 1.2
+
+ 
+ 
+ 
+ 
+ Total Inventory
+
+ 
+ 
+ 262.6
+
+ 
+ 
+ 434.0
+
+ 
+ 
+ 695.9
+
+ 
+ 
+ 
+ 
+ Source: DOE, Strategic Petroleum Reserve Annual Report for Calendar Year 2010 minus quantities noted in DOE Notice of Sale DE-NS96-11PO97000.
+
+ Notes: 
+
+ a.
+
+ Sulfur content not exceeding 0.5%. 
+
+ b.
+
+ Sulfur content greater than 0.5%.
+
+ c.
+
+ Total does not add due to rounding.
+
+ 
+
+ 
+
+ Bryan Mound
+
+ The Bryan Mound storage site is located in Brazoria County, TX, approximately three miles southwest of Freeport. The site has 20 storage caverns with a total storage capacity of 254 million barrels, and a cavern inventory of 240.7 million barrels. The Bryan Mound site began operation in 1986 and has remained operational since then.
+
+ Big Hill
+
+ The Big Hill storage site is located in Jefferson County, TX, approximately 26 miles southwest of Beaumont. The site has 14 storage caverns, a combined storage capacity of 171 million barrels, and a cavern inventory of 164.7 million barrels. The Big Hill site began full operation in 1991 and has remained operational since then.
+
+ West Hackberry
+
+ The West Hackberry storage site is located in Cameron Parish, LA, approximately 25 miles southwest of Lake Charles. The site has 22 storage caverns with a combined storage capacity of 228 million barrels, and a cavern inventory of 215.8 million barrels. The West Hackberry site began full operation in 1988 and has remained operational since then.
+
+ Bayou Choctaw
+
+ The Bayou Choctaw storage site is located in Iberville Parish, LA, approximately 12 miles southwest of Baton Rouge. The site has six storage caverns, an authorized storage capacity of 74 million barrels, and a cavern inventory of 73.6 million barrels. The Bayou Choctaw site began full operation in 1987 and has remained operational since then.
+
+ In October 2007, Bayou Choctaw's authorized cavern capacity temporarily decreased from 76 million barrels to 73.5 million barrels. Bayou Choctaw Cavern 20 had crept to within 60 feet of the salt dome's edge and required replacement due to the risk of breaching the salt dome. 17 The cavern passed all integrity tests and remains out of any immediate danger of leaking, however. To limit any risk, DOE reduced the oil stored in Cavern 20 from 7.5 million barrels to 3.2 million barrels by using only the upper portion of the cavern. DOE temporarily stored Cavern 20's oil in the Big Hill and West Hackberry caverns. Instead of physically expanding the caverns, additional storage space came from displacing the brine cushion at the bottom of the two caverns. The brine cushion helps counteract naturally occurring cavern creep that results from the salt dome's geological deformation. In November 2011, DOE acquired a 10-million-barrel replacement cavern, designated Cavern 102, in the Bayou Choctaw salt dome. The replacement cavern's development was scheduled for integration into the Bayou Choctaw system by January 2013. Cavern 102's completion will increase the site's capacity by 2.5 million barrels, replacing a 7.5 million barrel cavern with a 10 million barrel cavern. Plans then call for emptying and decommissioning Cavern 20. 18 
+
+ SPR Capacity
+
+ The Energy Policy Act of 2005 (EPAct) required expansion of the SPR to a maximum physical capacity of 1 billion barrels "as expeditiously as practicable." Advocates for expansion argued that the SPR would need to be larger for the United States to be able to maintain stocks equivalent to 90 days of net imports. DOE evaluated a site in Richton, MS, as a possible location for an additional 160 million barrels of capacity. However, in FY2011, the Obama Administration cancelled SPR expansion plans, citing an Energy Information Administration projection that "U.S. petroleum consumption and dependence on imports will decline in the future and the current Reserve's projection will gradually increase to 90 days by 2025." 19 
+
+ The SPR is designed with a drawdown rate of roughly 4.4 million barrels per day for up to 90 days; thereafter, the rate would begin to decline. Drawdown is limited by the capacity of the takeaway capacity of pipelines and marine terminals servicing the SPR. The first major drawdown in early 1991 (the Persian Gulf War) confirmed SPR's operability. A life extension program, initiated in 1993, upgraded or replaced all major systems to ensure the SPR's readiness to 2025.
+
+ The SPR's current capacity remains physically limited to 727 million barrels, with current inventory at 696 million barrels. Refilling the SPR after an ordered drawdown remains a presidential discretion, presumably at a time when the price of crude oil declines, or political and market conditions make it economically advantageous to do so.
+
+ The initial crude oil that filled the SPR came from purchases paid though appropriated funds. As an alternative to appropriated funds, DOE proposed accepting transfer of a discrete portion of the royalties payments collected by the Department of the Interior (DOI) for Gulf of Mexico oil leases in the form of royalty-in-kind (RIK) oil rather than as revenues. While RIK avoids the necessity of making outlays for purchasing oil, it also meant a loss of revenues in settling royalties in wet barrels rather than in cash payments to the U.S. Treasury. DOI worked out final details during late 1999 and 2001. The RIK program was used to transfer oil to the SPR to replace oil sold in the mid-1990s for deficit reduction purposes. In mid-November of 2001, President Bush ordered the SPR filled to 700 million barrels, principally through oil acquired as RIK. Between 1999 and 2009, RIK deliveries totaled roughly 162 million barrels and forgone receipts to the U.S. Treasury, an estimated $6.49 billion. In 2009, Secretary of the Interior Ken Salazar announced that he was ending the RIK program. 20 
+
+ Without the planned Richton site, even if the RIK program resumed, no additional capacity exists to store additional crude oil beyond the 727 million barrels. 
+
+ SPR Releases
+
+ DOE sells SPR oil through competitive bidding. It publishes a "notice of sale" that includes the volume, characteristics, and location of the petroleum for sale; delivery dates and procedures for submitting offers; as well as measures for assuring performance and financial responsibility. Bids are reviewed by DOE and awards offered. 21 DOE estimates that oil could enter the market roughly two weeks after the appearance of a notice of sale. 22 
+
+ To date, the SPR has released over 160 million barrels for various purposes ( Table 2 ). Presidents have ordered releases on three occasions, some 63 million barrels in total, in response to severe energy supply interruptions in coordination with other IEA member countries—the SPR's original intent. On 11 other occasions, DOE has lent oil (nearly 68 million barrels in total) to mitigate temporary supply interruptions. The borrowers repaid their loans by replacing the crude oil and added a small volume as a premium. On two occasions, sales generated revenue as a budget deficit reduction tool, as did the initial 1985 Weeks Island test sale.
+
+ The Clinton Administration introduced a new dimension to SPR drawdown and sale with its proposal in its FY1996 budget to sell 7 million barrels to help finance the SPR program. While agreeing that a sale of slightly more than 1% of SPR oil would not cripple U.S. emergency preparedness, some in Congress vigorously opposed the idea, in part, because it might establish a precedent that would bring about additional sales of SPR oil for purely budgetary reasons, as did indeed occur. There were three sales of SPR oil during FY1996. The first was to pay for the decommissioning of the Weeks Island site. The second was for reducing the federal budget deficit, and the third was to offset FY1997 appropriations. The total of 28.1 million barrels sold raised revenues of $544.7 million. Since then, the Obama Administration proposed selling SPR oil to reduce deficit spending in FY2011.
+
+ EPCA authorities permit "exchanges" of oil for the purpose of acquiring additional oil for the SPR. Under an exchange (also sometimes referred to as a loan), a company borrows SPR crude and later replaces it, including an additional quantity of oil as a premium for the loan. There were seven exchanges between 1996 and 2005. In June of 2006, after a temporary closure of a ship channel blocked crude oil shipments to two refineries, ConocoPhillips and CITGO borrowed 750,000 barrels of sour crude from the SPR and later replaced it plus additional "premium" barrels. In fall 2008, the SPR conducted a test exchange to address shortages that resulted from damages to petroleum infrastructure from Hurricanes Gustav and Ike. Following Hurricane Isaac, 1 MMB was exchanged with Marathon Oil due to disruptions to the commercial oil production, refining, and distribution operations in the Gulf Coast.
+
+ Some of the events precipitating major releases are discussed below.
+
+ 
+ 
+ Table 2. Strategic Petroleum Reserve History of Crude Oil Releases Summary
+
+ (sale or exchange in barrels)
+
+ 
+
+ 
+ 
+ 
+ Date
+
+ 
+ 
+ Purpose
+
+ 
+ 
+ Sale
+
+ 
+ 
+ Budget Deficit Reduction
+
+ 
+ 
+ Exchange
+
+ 
+ 
+ 
+ 
+ 1985 - November
+
+ 
+ 
+ Test Sale
+
+ After extending the Energy Policy and Conservation Act in June 1985, Congress authorized DOE to conduct test sales of up to 5 million barrels to involve the private sector in the competitive sales process.
+
+ 
+ 
+ 967,000
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1990 - October
+
+ 
+ 
+ Desert Shield
+
+ President George H. W. Bush ordered a 5-million-barrel test sale to "demonstrate the readiness of the [Reserve] system under real life conditions." Only 3.9 million barrels sold because of the lack of bids for one of the six types of crude oil advertised.
+
+ 
+ 
+ 3,900,000
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1991 - January
+
+ 
+ 
+ Desert Storm
+
+ President Bush authorized a 33.75 million barrel drawdown over a 45-day period under a coordinated emergency response plan drawn up by the International Energy Agency. DOE accepted bids from 13 companies that bid on only 17.3 million barrels of Reserve oil because industry offers for the higher-sulfur "sour" crude oil were substantially lower than bids for the lower-sulfur "sweet" crude.
+
+ 
+ 
+ 17,300,000
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1996 - March
+
+ 
+ 
+ Weeks Island Sale
+
+ After becoming geologically unstable, DOE decided to decommission the Weeks Island SPR Site, and offered 5.1 million barrels for sale.
+
+ 
+ 
+ 5,100,000
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1996 - April
+
+ 
+ 
+ Pipeline Blockage, Seaway Pipeline System
+
+ During a pipeline blockage to Cushing, OK, ARCO paid a fee plus a future price differential for leasing the oil, and replaced the oil with an equivalent grade of crude within six months under an emergency crude oil lease exchange agreement. 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 900,416
+
+ 
+ 
+ 
+ 
+ 1996 - May
+
+ 
+ 
+ Deficit Reduction
+
+ Omnibus Consolidated Rescissions and Appropriations Act of 1996, P.L. 104-134 .
+
+ 
+ Â 
+
+ 
+ 
+ 12,800,000
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1996 - October
+
+ 
+ 
+ Deficit Reduction
+
+ Omnibus Consolidated Appropriations Act of 1997, P.L. 104-208 .
+
+ 
+ Â 
+
+ 
+ 
+ 10,200,000
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 1998 - August
+
+ 
+ 
+ Maya Exchange
+
+ DOE exchanged 11 million barrels of Maya crude for 8.5 million barrels of other higher value crude oil to improve the SPR's operational efficiency.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 11,000,000
+
+ 
+ 
+ 
+ 
+ 2000 - June
+
+ 
+ 
+ Calcasieu Ship Channel Closure
+
+ DOE exchanged 500,000 barrels each with CITGO and Conoco, due to blockage of the ship channel that allowed incoming crude oil shipments to those refineries. Action taken in order to avert temporary shutdown of both refineries. 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 1,000,000
+
+ 
+ 
+ 
+ 
+ 2000 - August
+
+ 
+ 
+ Establish NEHHOR
+
+ DOE exchanged 2.8 million barrels of crude oil to pay for the first year of tank-storage and stocks for establishing a 2-million-barrel Northeast Home Heating Oil Reserve.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 2,836,000
+
+ 
+ 
+ 
+ 
+ 2000 - October
+
+ 
+ 
+ Exchange 2000
+
+ DOE exchanged 30 million barrels in response to concern over low distillate levels in Northeast. 
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 30,000,000
+
+ 
+ 
+ 
+ 
+ 2002 - October
+
+ 
+ 
+ Hurricane Lilli
+
+ DOE exchanged 98,000 barrels with Shell Pipeline Co. to secure Capline storage tanks in advance of Hurricane Lili.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 98,000
+
+ 
+ 
+ 
+ 
+ 2004 - September
+
+ 
+ 
+ Hurricane Ivan
+
+ DOE exchanged 5.4 million barrels of sweet crude due to disruptions in the Gulf of Mexico caused by Hurricane Ivan.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 5,400,000
+
+ 
+ 
+ 
+ 
+ 2005 - September
+
+ 
+ 
+ Hurricane Katrina
+
+ President George W. Bush issued a Finding of a Severe Energy Supply Interruption as defined in Section 161(d) of the Energy Policy and Conservation Act (EPCA - 42 U.S.C. 6 241(d)) and directed DOE to offer 15 million barrels of sweet crude and 15 million barrels of sour crude as part of an IEA coordinated effort. 10.8 million barrels of sweet crude and 200,000 barrels of sour crude sold.
+
+ 
+ 
+ 11,000,000
+
+ 
+ Â 
+
+ 
+ 
+ 9,800,000
+
+ 
+ 
+ 
+ 
+ 2006 - January
+
+ 
+ 
+ Barge Accident, Sabine Neches Ship Channel
+
+ DOE exchanged 767,000 barrels of sour crude with Total Petrochemicals USA due to closure of the Sabine Neches ship channel to deep-draft vessels after a barge accident in the channel. Action was taken to avert temporary shutdown of the refinery.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 767,000
+
+ 
+ 
+ 
+ 
+ 2006 - June
+
+ 
+ 
+ Calcasieu Ship Channel Closure
+
+ DOE exchanged 750,000 barrels of sour crude with ConocoPhillips and Citgo due to the closure for several days of the Calcasieu Ship Channel to maritime traffic. The closure resulted from the release of a mixture of storm water and oil. Action was taken to avert temporary shutdown of both refineries.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 750,000
+
+ 
+ 
+ 
+ 
+ 2008 - September
+
+ 
+ 
+ Hurricanes Gustav and Ike
+
+ Following Hurricanes Gustav and Ike, DOE loaned nearly 5.4 million barrels to Marathon, Placid, ConocoPhillips, Citgo, and Alon USA after their supplies had been cut off due to shutdown of the petroleum industry in the Gulf region. The companies repaid the loans with a premium of 93,350 barrels.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 5,389,000
+
+ 
+ 
+ 
+ 
+ 2011 - July
+
+ 
+ 
+ IEA Coordinated Release
+
+ President Obama issued a Finding of a Severe Energy Supply Interruption and directed DOE to offer 30 million barrels of sweet crude as part of an IEA coordinated effort to offset Libya's production curtailment.
+
+ 
+ 
+ 30,640,000
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 
+ 
+ 2012 - September
+
+ 
+ 
+ Following Hurricane Isaac, 1 million barrels was exchanged with Marathon Oil due to disruptions to the commercial oil production, refining, and distribution operations in the Gulf Coast.
+
+ 
+ Â 
+
+ 
+ Â 
+
+ 
+ 
+ 1,000,000
+
+ 
+ 
+ 
+ 
+ Total to date
+
+ 
+ 
+ 68,907,000
+
+ 
+ 
+ 23,640,000
+
+ 
+ 
+ 68,940,416
+
+ 
+ 
+ 
+ 
+ Source: U.S. DOE, http://fossil.energy.gov/ programs/ reserves/ spr/ spr-drawdown.html .
+
+ Notes: Barrels rounded to thousands.
+
+ 
+
+ 
+
+ 1990-1991 Severe Energy Supply Interruption─Desert Storm Desert Shield
+
+ In the aftermath of the Iraqi invasion of Kuwait on August 2, 1990, escalating gasoline prices and the prospect of a worldwide crude shortfall (approaching 4.5 million-5.0 million barrels daily) prompted calls for an SPR drawdown. The debate focused on whether SPR oil should be used to moderate anticipated price increases, before oil supply problems had become physically evident.
+
+ The George H. W. Bush Administration indicated that it would not draw down the SPR in the absence of a physical shortage simply to lower prices. On the other hand, some argued that a perceived shortage does as much immediate damage as a real one, and that flooding the market with stockpiled oil to calm markets is a desirable end in itself. From this perspective, the best opportunity to use the SPR came during the first months of the crisis, which some argued the Administration squandered. It became clear during the fall of 1990 that in a decontrolled market, physical shortages are less likely to occur. Instead, an expression of supply shortages comes in the form of higher prices, as purchasers are free to bid as high as they wish to secure scarce supply.
+
+ Within hours of the first air strike against Iraq in January 1991, the White House announced that President Bush was authorizing a drawdown of the SPR, and the IEA activated the plan on January 17. Crude prices plummeted by nearly $10/barrel in the next day's trading, falling below $20/bbl for the first time since the original invasion. Oil analysts attributed the price drop to optimistic reports about the allied forces' crippling Iraqi air power and the diminished likelihood, despite the outbreak of war, of further jeopardy to world oil supply. There appeared to be no need for the IEA plan and the SPR drawdown to help settle markets, and there was some criticism of it. DOE offered more than 30 million barrels of SPR oil for bid, but only accepted bids on 17.3 million barrels. Successful bidders took oil delivery in early 1991.
+
+ The Persian Gulf War drawdown provided an important example about ways to maximize the SPR's usefulness in decontrolled markets. Legislation enacted during the 101 st Congress ( P.L. 101-383 ), as previously noted, had expanded SPR drawdown authority by allowing its use in preventing minor or regional shortages from escalating into larger ones; for example, the shortages on the West Coast and price jump that followed the Alaskan oil spill of March 1989. In the 102 nd Congress, omnibus energy legislation ( H.R. 776 , P.L. 102-486 ) broadened the drawdown authority further to include instances where a reduction in supply appeared sufficiently severe to bring about an increase in the price of petroleum likely to "cause a major adverse impact on the national economy." 
+
+ 2005 Severe Domestic Energy Supply Interruptions─Hurricanes Katrina and Rita
+
+ Prior to 2005, growth in worldwide oil demand had begun to constrain U.S. refinery production, particularly as the demand for gasoline and refined products increased with an expanding economy. Hurricane Katrina followed by Hurricane Rita had severe and far-reaching effects on the U.S. petroleum. Each approaching hurricane caused production facilities in the Gulf of Mexico to shut down. The operations of the refining and distribution systems were interrupted once the hurricanes made landfall. Within two days of the devastation, DOE approved emergency loans of 9.8 million barrels of crude oil from the SPR to refineries whose supplies had been cut. The EIA then announced that its member countries had agreed to a coordinated emergency response to make 60 million barrels of crude oil and refined products available to help mitigate the disruptions in the flow of oil worldwide. DOE offered 30 million barrels for sale and executed sales contracts for 11 million barrels. Together with the loans, the SPR released 20.8 million barrels. The other EIA member countries released 8.8 million barrels of crude oil and 18.53 million barrels of refined petroleum products, for a total 27.33 million barrels, into the market. The EIA-released refined products, in particular, benefited the East Coast, which normally depended on Gulf Coast refineries. Receipts to the U.S. Treasury SPR Petroleum Account for 11 million barrels sold totaled $615.3 million. The 9.8 million barrels loaned to the petroleum industry were repaid to the SPR along with 500,000 additional premium barrels.
+
+ 2011 IEA Coordinate Release in Response to Libyan Crude Oil Curtailment
+
+ In its FY2012 Budget Request, the Obama Administration had proposed a $500 million sale of petroleum from the SPR, proposed for completion by March 1, 2012, for deposit in the General Fund of the Treasury. The House Energy and Water Committee recommended the $500 million sale provided that the quantity sold would be replaced during FY2012 under paragraph (a)1 or 3 of Section 160 of the Energy Policy and Conservation Act (42 U.S.C 6240 (a)(1) or (3)), which authorizes acquisition of crude oil produced from federal lands, or through purchase or exchange, respectively.
+
+ However, political unrest that began in Tunisia and spread to Egypt and Libya in early 2011 had led to the surge in oil prices observed during the first quarter of the year. To offset the loss of Libyan exports, calm markets, and to moderate prices, some congressional Members called for releasing oil from the SPR. Some reasoned that an oil release from the SPR would dampen speculative bidding that was driving the market, and would reduce prices in the short run.
+
+ By early March 2011, the price of West Texas Intermediate (a light sweet crude) traded on the New York Mercantile Exchange (NYMEX) exceeded $100 per barrel. In Europe, the price of Brent crude oil (a heavier and higher in sulfur crude than WTI) exceeded $115 per barrel. These prices (approximately 20% higher than before the outbreak of political unrest) reflected at least two important factors: first, expectations that the unrest could spread to other countries (some of which could be major oil producers), and second, an actual curtailment of Libyan exports (to an uncertain extent and for an unknown duration). As an offset to the lost Libyan crude exports, Saudi Arabia indicated that it would expand its exports to keep the world market supplied.
+
+ On June 23, 2011, the International Energy Agency (IEA) announced that its 28 member countries would release 60 million barrels of crude oil and refined products into the global market. As part of that action, the President directed a drawdown of the SPR to meet the U.S. response obligations for 30 million barrels, and DOE issued a Notice of Sale that same day. On June 24, 2011, DOE opened its web-based Crude Oil Sales Offer System for a five-day sale of 30.237 million barrels of light, sweet crude oil at a bid reference price of $112.78 a barrel. 23 DOE received more than 90 offers for SPR crude oil, and awarded 28 contracts to sell 30.64 million barrels of crude oil at an average price of $107.21 per barrel. The oil was sold from the Bryan Mound and Big Hill sites in Texas, and the West Hackberry, LA, site.
+
+ Other Policy Considerations
+
+ In a market where there is no physical shortage, oil companies may have limited interest in purchasing SPR oil unless they have spare refining capacity to turn the crude into useful products, or want to build crude oil stocks. 24 The U.S. government bases its notice of sale on the previous five-day average of the price of the grade of crude oil it intends to sell, and accepts bids it considers responsive. If the notice itself does not prompt, or contribute to, a softening of prices, there may be limited interest on the part of the oil industry in bidding on SPR supply. Although the possibility exists that prices might decline if additional refined product is released into the market, it is impossible to predict what quantitative effect an SPR crude drawdown would have. For example, following the June 23, 2011, announcement of a 30 million barrel release of oil from the SPR, daily oil prices briefly declined from $94.96 per barrel to $90.70, and then returned to their previous levels within a week.
+
+ There are additional considerations. A unilateral drawdown on U.S. strategic stocks would probably have less impact on the world oil market than a coordinated international drawdown of the sort that occurred after the 2011 release to meet IEA obligations vis-Ã -vis Libya's production curtailment. Some might argue that it would be unwise under any scenario for the United States to draw down its strategic stocks while other nations continue to hold theirs at current levels. Additionally, it is always possible that producing nations will reduce production to offset any SPR oil delivered into the market. In 2013, some might argue that the market is already well-supplied and that short-term supply concerns are not keeping prices high, but current and anticipated geopolitical events are contributing to higher prices. Others argue that the oil commodity futures market is behind speculative bidding that has driven prices higher.
+
+ Some have perceived the SPR as a defensive policy tool against high oil prices. If an SPR release has no discernible impact on oil prices, it is possible that the SPR will lose some of whatever psychological advantage it exercises on prices when left as an untapped option.
+
+ Refining Capacity vs. Crude Supply
+
+ While the number of U.S. refineries that process crude oil into fuels has decreased over the last decade, refining capacity has increased somewhat. In 2012, CRS reported 115 refineries operating with nearly 18 million barrels per day in capacity (this includes three refinery complexes each made up of two formerly independent refineries). Some 55 refineries have coking process for converting petroleum resid to higher value products. The Gulf Coast region (Petroleum Administration for Defense District 3) makes up nearly 45% of the U.S. refining capacity with 45 refineries processing more than 8 million barrels per day. The region also has the highest concentration of coking refineries. 
+
+ Over the last 25 years, the API gravity of imported crude oils had been decreasing, while average sulfur content had been increasing. API gravity, a measure developed by the American Petroleum Institute, expresses the "lightness" or "heaviness" of crude oils on an inverted scale. With a diminishing supply of light, sweet (low sulfur) crude oil, U.S. refineries had to add coking capacity to convert lower-priced heavier, sour crude oils to high-value products such as gasoline, diesel, and jet fuel. 
+
+ The Government Accountability Office (GAO) observed in 2006 that 40% of the crude oil refined by U.S. refineries was heavier than that stored in the SPR, and that the proportion of stored crude oil grades was not as compatible as it could be with refineries that had been moving towards heavier grades of crude oils. 25 Based on a 2005 SPR crude oil compatibility study, DOE agreed that the SPR could store a small percentage of heavy crude to satisfy the short-term needs of a few refineries in the event of a supply disruption. However, DOE argued, the current mix of crudes was compatible for use in the majority of refineries, and suggested considering the addition of heavy crude for any future expansion of the SPR. 26 
+
+ Refineries that process heavy oil cannot operate at normal capacity if they run lighter oils. Refiners reported to GAO that running lighter crude in units designed to handle heavy crudes could impose as much as an 11% penalty in gasoline production and 35% in diesel production. The agency reported that other refiners indicated that they might have to shut down some of their units. The types of oil currently stored in the SPR would not be fully compatible with 36 of the 74 refineries considered vulnerable to supply disruptions. (A majority of the refineries that have pipeline access to the SPR are located in the Gulf Coast region and the Midwest region.) GAO cited a DOE estimate that U.S. refining throughput would decrease by 735,000 barrels per day (or 5% of total U.S. refining capacity) if the 36 refineries had to use SPR oil—a substantial reduction in the SPR's effectiveness during an oil disruption, especially if the disruption involved heavy oil.
+
+ In response to the 2006 GAO report, DOE agreed to consider storing heavy crudes if an opportunity were to occur through expansion. However, the expansion plans were cancelled in 2011. In addition, since 2006, the SPR updated its crude compatibility study and concluded in its 2010 report that storing heavy crude in the SPR would not provide a net benefit in the event of a supply disruption. 27 
+
+ As of late, however, light sweet crude production has increased in the United States. Unconventional resources such as the Bakken, Utica, and Eagle Ford shales are producing crude oils comparable to West Texas Intermediate (WTI), the benchmark for light sweet crude oil. Producers have also returned to the Texas Permian Basin, the historic source of WTI. The increasing supply of lower-priced light sweet crude oil has begun to edge out heavier crude oils in supplying U.S. refineries. Some refineries are bypassing their coking units to run the lighter crudes given the economic advantage that these lower-priced crudes offer.
+
+ Gasoline Price Increases 
+
+ In recent years, increases in the price of gasoline have been tied to calls for the release of reserves from the SPR. For example, over the first two months of 2012, retail gasoline prices increased by over 15%. The price of gasoline rose from an average price of $3.21 per gallon in late December 2011 to a price of $3.64 in late February. Prices continued to go up, rising to a U.S. average of $3.92 per gallon as of March 26. 28 With these higher prices came calls for, and against, the release of crude oil from the SPR as a way to control price increases. 
+
+ Although there is a general recognition that a release from the SPR would likely only provide temporary relief from rising prices, some view it as a signal to the market that a continuing spiral of prices would be met by resolve and policy action by the United States.
+
+ The judgment that a release of crude oil from the SPR provides only temporary relief from rising prices seems well founded. On June 23, 2011, when gasoline prices were at $3.60 a gallon, President Obama announced a 30 million barrel release from the SPR under IEA obligation. The price of gasoline declined by about 2% over the next two weeks following the SPR release announcement, but by July 8, 2011, the price had again reached $3.61 per gallon, approximately the same level as before the release. Gasoline prices continued to rise through the first week of August, before declining later that month. Gasoline prices averaged about $3.60 per gallon in August 2011, declining to $3.40 per gallon in October and $3.21 per gallon in December. The gasoline price reductions in the fourth quarter of 2011 were likely related to the reductions in crude oil prices between August and October 2011, in light of the lag between acquiring title to crude oil and the oil becoming available as retail gasoline, as well as refineries switching production from summer to winter grade gasoline.
+
+ Crude oil prices also responded immediately to the release of oil from the SPR. The price of oil was $94.96 per barrel on June 22, 2011. 29 On June 23, the day President Obama announced the SPR release, the price fell to $90.70 per barrel. By June 30, 2011, the price had risen to $95.73 per barrel, exceeding the price before the announcement. The initial market response to the SPR release lasted about one week. However, the announcement of the SPR release promised to deliver the oil to market by the end of August. The price of oil began to decline in August 2011 and generally declined during August and September, until reaching $75.40 per barrel on October 4, 2011. Thereafter, prices began to rise, exceeding $100 per barrel later in the year. 30 
+
+ The gasoline price increases of 2012, like virtually all previous price increases, resulted from an increase in the price of crude oil. Crude oil price increases generally result from actual or anticipated market tightening, that is, an increase in demand, a reduction in supply, or both. For example, many viewed the price increases of 2008 as related to the rapid expansion of petroleum demand in China, India, and other emerging markets. In 2011, the price increases were thought to be largely attributable to the loss of Libyan production during the revolution in that country. In 2012, although there are some reductions in supply due to instability in South Sudan, Yemen, and other areas, the primary driver of higher prices seems to be tensions with Iran and related policy responses by both sides in the controversy over Iranian nuclear capability.
+
+ This environment, where current supplies are uninterrupted but speculation concerning future availability is active, may appear to some observers to be a situation that a release from the SPR would do little to mitigate. For example, if Iranian military action succeeded in blocking the Strait of Hormuz, it would prevent over 17 million barrels per day of crude oil from reaching the market. This quantity is almost four times the size of the maximum drawdown capability of the SPR, if acting alone. However, an event of such size would almost certainly trigger an international response and a coordinated release of crude oil and products from the United States as well as the 27 other IEA member countries.
+
+ As the nature of the response to Iran's nuclear development project evolves, and especially if it results in reduced actual supplies of oil on the world market, a drawdown from the SPR might become more effective in reducing oil prices. However, until an actual reduction in supply materializes, releases from the SPR are unlikely to resolve speculative concern on the oil markets.
+
+ The Future of U.S. Imports of Crude Oil
+
+ The ability of the SPR to supplement the domestic U.S. supply of crude oil and effectively replace imports depends on the size of the reserve as well as its drawdown capabilities. Its effectiveness also depends on the volume of U.S. imports and the rate of U.S. consumption.
+
+ Crude oil imports are the difference between U.S. demand and domestic production. If either demand falls, or domestic production rises, the need for imports declines. Because of a number of factors, some temporary, including the recession, high prices, and conservation, U.S. consumption of petroleum products has declined since 2005 by about 9.5%. This decline in consumption has reduced the demand for crude oil. Over the same period, U.S. production of crude oil increased from 5.18 million b/d to 5.67 million b/d, an increase of 9.5%. The combination of falling consumption and increasing production has reduced the share of imports in total consumption from 49% in 2005 to 45% in 2011. In addition, Canada increasingly provides the United States with crude oil imports, and arguably represents a secure source of supply.
+
+ If the trends of the last six years continue, the United States will rely less on crude oil imports. Consequently, the SPR, even if its capacity and contents remain fixed, may be better able to meet U.S. requirements in times of supply shortage on the world market.
+
+ Proposals in the 113 th Congress (1 st Half)
+
+ The 113 th Congress has introduced bills that would, among other things:
+ modernize the composition of the crude oils stored in the SPR to reflect the demands of the U.S. refining industry;
+
+ study the need for creating a national refined products reserve;
+
+ limit sales of the SPR until approval of the Keystone XL pipeline; and
+
+ fund the SPR's continued operation and maintenance.
+ H.R. 787 —the Infrastructure Jobs and Energy Independence Act 31 —included the provision under Title II -Modifying The Strategic Petroleum Reserve a nd Funding Conservation a nd Energy Research and Development that would modernize the composition of the SPR to reflect the current processing capabilities of U.S. refineries, and provide increased funding to accelerate conservation, energy research and development, and assistance through existing programs.
+
+ H.R. 2256 —the Gas Price and Refinery Capacity Relief Act of 2013 32 —would require the Secretary of Energy to study and report to Congress on the costs and benefits of creating a national strategic refined petroleum products reserve for refined petroleum products ( Study on National Strategic Refined Petroleum Products Reserve , paragraph (f)).
+
+ H.R. 2609 —the Energy and Water Development and Related Agencies Appropriations Act of 2014 33 —provided the SPR with $189,400,000 for annually operating costs.
+
+ S. 167 —the Strategic Petroleum Supplies Act 34 —would limit the sale of petroleum products from the SPR until the date on which all permits necessary under permits for the Keystone XL pipeline project have been issued, except for U.S. obligation under international treaty.
+
+ S. 1073 —the Gas Price and Refinery Capacity Relief Act of 2013 35 —would require the Secretary of Energy to study and submit to Congress a report on the costs and benefits of creating a national strategic refined petroleum products reserve for refined petroleum products ( Study on National Strategic Refined Petroleum Products Reserve , paragraph (f)).
+
+ S. 1245 —the Energy and Water Development and Related Agencies Appropriations Act, 2014 36 —included $189,400,000 in necessary ex penses for Strategic Petroleum Reserve facility development and operations and program management activities.
+
+ 
+
+ 
+ Author Contact Information
+ 
+ [author name scrubbed], Specialist in Energy Economics
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ Acknowledgments
+
+ [author name scrubbed], Specialist in Energy Policy
+
+ Beth A. Roberts, Information Research Specialist
+
+ [author name scrubbed], Specialist in Energy Policy
+
+ Diana Greenhalgh, DOE SPR Program Analyst
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ The Strait of Hormuz is the narrow waterway that forms the entrance to the Persian Gulf from the Gulf of Oman and ultimately the Arabian Sea and a key artery of the global oil market. Persian Gulf oil exporters are Iraq, Kuwait, Saudi Arabia, Iran, the United Arab Emirates, and Qatar. In 2010, the United States imposed economic sanctions that targeted Iran's energy and banking sectors, and have affected its ability to export crude oil and import refined petroleum products. (See the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010, P.L. 111-195 .) Additional legislation prohibits expending SPR appropriations on anyone engaged in providing refined products to Iran, or assisting Iran in developing additional internal capacity to refine oil. (See the FY2010 Energy and Water Appropriations Act, P.L. 111-85 ). For further information on Iran's threat, refer to CRS Report R42335, Iran's Threat to the Strait of Hormuz , coordinated by [author name scrubbed].
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ Energy Information Administration, U.S. Department of Energy, The Strait of Hormuz is the world's most important oil transit chokepoint , Today in Energy, January 4, 2012, http://www.eia.gov/todayinenergy/detail.cfm?id=4430# .
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ Barbara Starr and Phil Gast, "U.S. Navy won't tolerate 'disruption through Strait of Hormuz," CNN U.S. , December 28, 2012, http://articles.cnn.com/2011-12-28/middleeast/world_meast_iran-us-hormuz_1_strait-iran-hormuz?_s=PM:MIDDLEEAST .
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ Refer to CRS Report R41478, The U.S. Oil Refining Industry: Background in Changing Markets and Fuel Policies , by [author name scrubbed] et al. 
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ These have included the Arab oil embargo (1973-1974), the deposing of the Shah of Iran, followed by the Iranian revolution (1979-1980), the first Gulf War (1990), and production cuts by the Organization of the Petroleum Exporting Countries (OPEC) and a resurgence in world oil demand (early 1999 into the fall of 2000). Starting in 2003 with the U.S. invasion of Iraq, crude oil and product prices began rising to a new nominal high reached in the summer of 2008 for a range of reasons, which are discussed in CRS Report R42024, Oil Price Fluctuations , by [author name scrubbed] and [author name scrubbed]. Some of the dynamics behind more recent prices are linked to natural events (such as Hurricanes Rita, Katrina, and Gustav) that disrupted Gulf Outer Continental Shelf (OCS) oil production and the 2010 BP Macondo well blowout that resulted in a moratorium on OCS drilling permits. The latest rise, at the time of this paper, may depend on how events in Iran play out.
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ P.L. 94-163 , Section 154 Strategic Petroleum Reserve Plan.
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ The Energy Policy Act of 2005, P.L. 109-58 Section 301 Permanent Authority to Operate the Strategic Petroleum Reserve and Other Energy Programs.
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ IEA member countries are Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Republic of Korea, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom, and the United States. See http://www.iea.org/about/membercountries.asp .
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ Personal communication, Diana Greenhalgh, DOE SPR Program Analyst, April 18, 2012.
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ See http://www.iea.org/Textbase/subjectqueries/keyresult.asp?KEYWORD_ID=4103 .
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ 42 U.S.C. §6241 (a).
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ 42 U.S.C. §6241 (h).
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ 42 U.S.C. §6241 (g).
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ Oil stored at a fifth SPR site, Weeks Island, LA, was transferred and the site was decommissioned in 1996 because of problems with the structural integrity of the cavern unrelated to drawdown activity.
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ Details and current levels of SPR inventory are updated regularly at http://www2.spr.doe.gov/DIR/SilverStream/Pages/pgDailyInventoryReportViewDOE_new.html .
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ DOE Notice of Sale DE-NS96-11PO97000.
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ Personal communication with David Johnson, DOE Deputy Assistant Secretary for Petroleum Reserves, March 7, 2011.
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ On March 1, 2011, Senators Jack Reed and Sheldon Whitehouse urged President Obama to sell the oil from the Bayou Choctaw cavern rather than move it to a new cavern as proposed by DOE.
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ Department of Energy, "Cancellation of Supplemental Environmental Impact Statement for Ancillary Facilities for the Richton Site of the Strategic Petroleum Reserve," 76 Federal Register 55890, September 9, 2011.
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ 21 U.S. Department of the Interior, Secretary Salazar Ends Controversial Royalty in Kind Program, http://www.doi.gov/news/radioactualities/2009_09_16_actuality.cfm .
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ 10 C.F.R. §625.
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ See http://www.fe.doe.gov/programs/reserves/spr/spr-facts.html . For more detail on the sales procedure, see U.S. Federal Register , Department of Energy, Price Competitive Sale of Strategic Petroleum Reserve Petroleum; Standard Sales Provisions: Final Rule , July 27, 2005, pp. 39,363-39,382; available at http://www.fe.doe.gov/programs/reserves/spr/spr_rule_070705.pdf . DOE has a history of SPR drawdowns, sales, and exchanges on the web at http://www.fe.doe.gov/programs/reserves/spr/spr-drawdown.html .
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ The bid reference price is determined by the average five-day price of Louisiana Light Sweet Crude oil traded prior to the Notice of Sale. Offers are submitted against the price and, as the sale progresses, bids will reflect market conditions. Under the terms of the SPR's Standard Sales Provisions, final prices are not determined until delivery to purchaser has been completed.
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ Refining capacity utilization rates are 83.7%Â for the first quarter of 2012, about 1.3% higher than the same period in 2011 taking into account seasonal maintenance and other events that will take refinery units offline temporarily. See Table 2 at http://www.eia.doe.gov/oil_gas/petroleum/data_publications/weekly_petroleum_status_report/wpsr.html .
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ U.S. Government Accountability Office, Strategic Petroleum Reserve—Options to Improve the Cost-Effectiveness of Filling the Reserve , GAO-08-512T, February 26, 2008, http://www.gao.gov/new.items/d08521t.pdf .
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ Personal communication with Diana Greenhalgh, DOE SPR Program, April 18, 2012.
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ Office of Deputy Assistant Secretary for Petroleum Reserves, Strategic Petroleum Reserve Updated Crude Compatibility Study , Department of Energy, April 2010.
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ Gasoline prices in this section are for Energy Information Administration, conventional regular gasoline. Available at http://www.eia.doe.gov .
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ The price of crude oil used in this section is the West Texas Intermediate spot price. The data are available at http://www.eia.doe.gov .
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ Definitive conclusions concerning the relationship between the release of oil from the SPR, changes in the price of oil, and changes in the price of gasoline are imprecise. Many other factors may have also affected the prices during the period, either reinforcing or moderating the effect of the SPR release.
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ Referred to the Subcommittee on Regulatory Reform, Commercial and Antitrust Law, on April 8, 2013.
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ Referred to the Subcommittee on Energy and Power, June 7, 2013.
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ Placed on Senate Legislative Calendar under General Orders, Calendar No. 134, July 16, 2013.
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ Read twice and referred to the Committee on Energy and Natural Resources, January 29, 2013.
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ Referred to the Committee on Energy and Natural Resources, 5/23/2013.
+
+ 
+ 
+ 
+ 36 .
+ 
+ 
+ (Placed on Senate Legislative Calendar under General Orders. Calendar No. 101 6/27/2013.)
\ No newline at end of file
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+DOE's Office of Electricity Delivery and Energy Reliability (OE): A Primer, with Appropriations for FY2016
+
+ February 10, 2016
+ (R44357)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ Background 
+
+ Organization and Strategy 
+
+ Mission 
+
+ Organizational Structure 
+
+ Strategy and Planning 
+
+ DOE Quadrennial Technology Review 
+
+ Grid Modernization Multi-Year Program Plan (MYPP) 
+
+ Administration Perspective and Goals 
+
+ Program Funding History 
+
+ Spending History in Context 
+
+ Recovery Act Funding 
+
+ Funding Comparison with Energy Technologies 
+
+ Recent Appropriations History 
+
+ FY2016 Highlights 
+
+ Summary 
+
+ Congressional Action 
+
+ Funding Increases 
+
+ Increases Ranked by Program 
+
+ Highlights of Key Program Increases 
+
+ Cross-Cutting Initiatives 
+
+ FY2016 Funding Table 
+
+ Program Goals and Activities 
+
+ Clean Energy Transmission and Reliability (CETR) 
+
+ Transmission Reliability Program 
+
+ Advanced Modeling Grid Research Program 
+
+ Energy Systems Risk and Predictive Capability (ESRPC) Program 
+
+ Smart Grid R&D 
+
+ Microgrids 
+
+ Advanced Distribution Management Systems (ADMS) 
+
+ Market-Based Control Strategies (MBCS) 
+
+ Cybersecurity for Energy Delivery Systems (CEDS) 
+
+ Energy Storage 
+
+ Transformer Resilience and Advanced Components (TRAC) 
+
+ National Electricity Delivery (NED) 
+
+ Infrastructure Security and Energy Restoration (ISER) 
+
+ State Energy Reliability and Assurance Grants 
+
+ Grants for Electricity Transmission, Storage, and Distribution Reliability 
+
+ Energy Assurance Grants 
+
+ Program Direction 
+
+ Additional Reports Related to OE Programs, Funding, and Policy 
+
+ 
+ 
+ Figures
+
+ 
+ Figure 1. OE Organizational Structure 
+
+ Figure 2. DOE Energy Technology Share of Funding, Comparison over Three Periods 
+
+ 
+ 
+
+ 
+ Tables
+
+ 
+ Table 1. OE Requests and Final Appropriations, FY2011–FY2016 
+
+ Table 2. OE FY2016 Appropriations Chronology 
+
+ Table 3. OE FY2016 Program Increases, in Rank Order 
+
+ Table 4. Electricity Delivery and Energy Reliability (OE) Appropriations 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ The nation's energy infrastructure is undergoing a major transformation. New technologies and changes in electricity flows place increasing demands on the electric power grid. These changes include increased use of distributed (mostly renewable energy) resources, Internet-enabled demand response technologies, growing loads from electric vehicle use, continued expansion of natural gas use, and integration of energy storage devices.
+
+ The Department of Energy's (DOE's) Office of Electricity Delivery and Energy Reliability (OE) is tasked with the lead role to address those infrastructure issues. OE is also responsible for the physical security and cybersecurity of energy infrastructure. As an illustration, OE reports that, during FY2014, its programs responded to 24 energy-related emergency events, including physical security events, wildfires, severe storms, fuel shortages, and national security events.
+
+ Since 2005, the Energy and Water Development (E&W) appropriations bill has funded all DOE programs, including those operated by OE. That office manages five types of research and development (R&D) programs, usually conducted in cost-shared partnership with private sector firms. OE also operates two types of deployment programs, conducted mainly with state and tribal governments. Each OE program office has its own set of goals and objectives.
+
+ President Obama has declared grid modernization to be a high priority, stressing its importance to jobs, economic growth, and U.S. manufacturing competitiveness. Further, OE has a key role in supporting the grid integration of renewable energy, which is a focus of the President's Climate Action Plan and is a strategic resource for state responses to the Environmental Protection Agency's proposed Clean Power Plan.
+
+ DOE's FY2016 request for OE sought $270 million, nearly double the FY2015 appropriation of $147 million. As part of that requested increase, DOE proposed to create a new Transformer Resilience R&D program and a new State Energy Reliability and Assurance grant program. About half of the requested OE increase would have gone to the new grant program. The next largest increases were sought for the Smart Grid and Cybersecurity programs. The FY2016 request also noted that OE plays the central role in two of DOE's broad cross-cutting initiatives: grid modernization and cybersecurity.
+
+ For the OE portion of the FY2016 E&W bill ( H.R. 2028 ), the House approved $187 million (includes $0.9 million rescission) and the Senate Appropriations Committee approved $151 million (includes $0.9 million rescission); but the Administration issued a veto threat. Ultimately, E&W appropriations appeared as Division D of the Consolidated Appropriations Bill ( H.R. 2029 ). The bill was enacted as P.L. 114-113 . The law provided $206 million for OE. The proposed new grant program was not funded, but funding was provided for the new Transformer Resilience program. Both the Smart Grid and Cybersecurity programs received larger amounts than were requested. 
+
+ 
+ 
+ DOE's Office of Electricity Delivery and Energy Reliability (OE): A Primer, with Appropriations for FY2016
+
+ 
+ Background
+
+ The federal government first supported a program for energy storage and electric power system technology during the 1970s, before the establishment of the Department of Energy (DOE). In the early days, the program was focused mainly on energy storage—especially to even out the variable power production from wind and solar technologies—but also to support large coal and nuclear power plants. The development of computer capacity and miniaturization has expanded the ability of grid operators to monitor and control electric power flows. The subsequent increase in networking of computerized devices for grid data collection and control advanced the ability of operators to anticipate, avoid, and otherwise mitigate potential power crises, such as blackouts. However, in more recent years, the computerization and networking have become vulnerable to unwanted computer-driven intrusions and disruptions, revealing a new cybersecurity challenge for electric power system technology.
+
+ The nation's energy infrastructure is diverse and complex. It includes distributed networks, varied system structures (electricity, oil, and natural gas), an array of operating models (public and private), and different systems in both the physical space and cyberspace. The energy sector consists of thousands of electricity, oil, and natural gas assets 1 that are geographically dispersed and provide for all nationally important systems and networks. Thus, interdependency within the sector and across the nation's critical infrastructure sectors is significant. Coordinating the security and resilience of energy assets is complicated by the borderless nature of energy and reliance on predominantly privately owned infrastructure.
+
+ Key challenges and opportunities facing the electric power industry include a changing power generation mix, replacing aging infrastructure (transmission, storage, distribution, and generation); updating communication networks (e.g., analog to digital); accommodating new end-use technologies such as distributed resources; planning for increased interdependencies of natural gas, water, and electricity systems; and devising business models that manage these challenges in providing reliable and affordable electricity service. These activities must be balanced against the need for cost control, physical security, cybersecurity, improved reliability and resiliency, and flexibility to deal with market uncertainties and a changing climate. Additional opportunities arise due to increasing natural gas production from shale and decreasing costs for information technologies that allow grid operators to better monitor and control the grid and that enable customers to better manage power use.
+
+ Organization and Strategy
+
+ Mission
+
+ The DOE Office of Electricity Delivery and Energy Reliability (OE) is charged with a mission to support more economically competitive, environmentally responsible, secure, and resilient U.S. energy infrastructure. 2 To achieve that mission, OE supports electric grid modernization and resiliency through research and development (R&D), demonstration projects, partnerships, facilitation, modeling and analytics, and emergency preparedness and response. It is the federal government's lead entity for energy sector-specific responses to energy security emergencies—whether caused by physical infrastructure problems or by cybersecurity issues.
+
+ OE leads DOE's efforts to strengthen, transform, and improve our energy infrastructure so that consumers have access to reliable, secure, and clean sources of energy. To accomplish this mission, the Office works with private industry and federal, state, local, and tribal governments on a variety of initiatives to modernize the electric grid. Grid modernization is critical to addressing aging infrastructure, achieving public policy objectives, sustaining economic growth, supporting environmental stewardship, and mitigating risks to secure the nation. The goal for the future grid is to support economic growth and energy innovation through delivery of reliable, affordable, and clean electricity to consumers where, when, and how they want it. 3 
+
+ Organizational Structure
+
+ In 2007, DOE established an independent Assistant Secretary for OE and, thereby, elevated the office to an administrative status equal to that for the major energy technologies (nuclear, fossil, renewables). 4 OE currently has five deputy assistant secretaries, each of whom reports to the Assistant Secretary. This structure is displayed in Figure 1 , below.
+
+ 
+
+ 
+ 
+ 
+ 
+ 
+ Figure 1. OE Organizational Structure
+
+ (As of January 2016)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: DOE, Office of Electricity Delivery and Energy Reliability, Our Organization , http://energy.gov/ oe/ about-us/ our-organization .
+
+ 
+ 
+ 
+ 
+
+ Strategy and Planning
+
+ OE's mission is guided mainly by two key DOE planning documents: the Quadrennial Technolo gy Review and the Grid Modernization Multi-Year Program Plan .
+
+ DOE Quadrennial Technology Review
+
+ DOE's second (2015) Quadrennial Technology Review (QTR) outlined key elements of the department's strategy for grid modernization. The report concluded that 
+
+ Fundamental changes in both supply and demand technologies are placing new requirements on the electric power system. On the supply side, there is a diversification of resources as aging, low-efficiency capacity is replaced by a mix of central stations and distributed generation, powered by a mix of fossil and renewable resources. On the demand side, diversification includes a rapidly growing use of distributed generation and interactive control systems in buildings, industrial equipment, and consumer goods. Accompanying these changes is a convergence of digital communications and control systems ("smart grid" technologies) to improve performance and engage consumers. Additionally, grid operations are moving from directing systems with a handful of control points at central stations to ones with potentially millions of highly interactive distributed control points. These trends create new technical requirements for a grid that is more flexible and agile, with the ability to dynamically optimize grid operations in near-instant time frames." 5 
+
+ Further, from the cross-cutting programs viewpoint, the report stressed the R&D aspects of grid modernization:
+
+ The electric grid is transitioning from a centrally-controlled, predictable system with one-way power flows in distribution to a much more distributed, stochastic, and dynamic system with bi-directional flows in distribution. Growth in the deployment of variable generation, electronic converters, and digital communications and control technologies is impacting core characteristics of the electricity system. Grid-related technologies need to evolve with the changing supply and end-use technologies landscape. Simultaneously, the RDD&D [research, development, demonstration, and deployment] associated with technologies that connect to the grid (e.g., renewable power supplies, efficient motor controllers, and smart loads) should consider the evolving interface with the grid. If electricity displaces petroleum and natural gas in electric vehicles and heating applications, respectively, the grid may serve an even more central role in the future energy system. The RDD&D opportunities identified for this rapidly evolving sector include planning models, operational tools, transmission components, distribution hardware, control systems, electricity storage and cybersecurity. These opportunities need to be developed in anticipation of an agile, flexible, and resilient electric power system to enable effective integration of variable supplies and participatory demand. 6 
+
+ Grid Modernization Multi-Year Program Plan (MYPP)
+
+ DOE's 2015 Grid Modernization MYPP describes its vision for "a future electric grid that provides a critical platform for U.S. prosperity, competitiveness, and innovation by delivering reliable, affordable, and clean electricity to consumers where they want it, when they want it, how they want it." 7 To help achieve this vision, DOE targets three key national targets:
+ A 10% reduction in the economic costs of power outages by 2025.
+
+ A 33% decrease in the cost of reserve margins while maintaining reliability by 2025.
+
+ A 50% decrease in the net integration costs of distributed energy resources by 2025. 8 
+ The initiative will assess its progress not only by looking at RD&D efforts in individual technical areas but also by looking at three integrated demonstrations, referred to in the MYPP as DOE major technical achievements. They are:
+ 1. A transmission and distribution system operating reliably on a lean reserve margin . Full power system visibility will be provided by real-time sensor networks enabling new approaches to system design, control, operations, protection, and optimization. There will be an integrated effort to demonstrate the delivery of reliable and affordable grid services with a substantially reduced amount of system reserve capacity.
+
+ 2. Resilient distribution feeders with high percentages of low-carbon distributed energy resources (50%) . This will be achieved through advances in real-time system monitoring, for high penetration of clean, distributed generation, and the proliferation of smart consumer end-use devices. There will also be new approaches to distributed control, engagement with bulk system reliability management, and coordination across local intelligent assets, including multiple microgrids, over a range of feeder innovations that meet both changing consumer expectations and traditional demand for reliability, resilience, and affordability.
+
+ 3. An advanced modern grid planning an d analytics platform . This will be a platform of integrated high performance tools that couple transmission, distribution and communications tools. These tools will have the capacity to reflect uncertainty, and substantially increase the speed and productivity of tools that enable stakeholders to achieve timely evaluation of future grid alternatives. This platform will be integrated with vendor products and leveraged into ongoing technical assistance with states and regions to substantially improve planning and regulatory assessments of the modern grid. 9 
+ The MYPP states that multiple demonstrations will be conducted across various regions of the country to underpin these "major technical achievements." Those major grid modernization achievements will be supported by six specific technical areas: (1) Devices and Integrated Systems Testing, (2) Sensing and Measurements, (3) System Operations, Power Flow, and Control, (4) Design and Planning Tools, (5) Security and Resilience, and (6) Institutional Support. 10 
+
+ Administration Perspective and Goals
+
+ OE also plays a critical role in implementation of the President's Climate Action Plan to mitigate the risks and enhance resilience against threats posed by climate change. The FY2016 OE request aimed to support the Administration's "all-of-the-above" energy strategy and emphasized priorities that increase electric grid resilience—through managing risks, increasing system flexibility and robustness, increasing visualization and situational awareness, and deploying advanced control capabilities.
+
+ Program Funding History
+
+ Spending History in Context
+
+ Historically, electric systems technology development programs have supported all four major types (nuclear, fossil, renewable, efficiency) of energy technology. For most of DOE's funding history, OE programs received a relatively small portion of funding, compared to the portion provided for the energy technology programs. 11 
+
+ Recovery Act Funding
+
+ However, the OE program received a major one-time boost in funding—$4.5 billion—from the American Recovery and Reinvestment Act of 2009 (Recovery Act, P.L. 111-5 ). 12 The funding was targeted for "grid modernization." Thus, much of it was used to provide grants to the electric utility industry to deploy smart grid technologies to modernize the electric grid. As a part of these programs, independent system operators (ISOs), regional transmission organizations (RTOs), and electric utilities installed about 1,100 synchrophasors 13 and other related technologies in their electric power transmission systems. 14 That deployment of synchrophasors, however, covered only a small portion of the total national grid.
+
+ Funding Comparison with Energy Technologies
+
+ Figure 2 provides a condensed visual summary of the relative portion of funding for electric systems in three different historical time periods.
+
+ 
+ 
+ 
+ 
+ 
+ Figure 2. DOE Energy Technology Share of Funding, Comparison over Three Periods
+
+ (Chart taken from CRS Report RS22858)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: DOE Budget Authority History Table by Appropriation , May 2007; DOE Congressional Budget Requests (several years); DOE (Pacific Northwest Laboratory), An Analysis of Federal Incentives Used to Stimulate Energy Production , 1980; DOE Conservation and Renewable Energy Base Table. February 1990. Deflator Source: The Budget for Fiscal Year 201 6 . Historical Tables. Table 10.1.
+
+ Notes: Column to far left shows shares for the period FY1948-FY2015; middle column shows shares for period from FY1978-FY2015; and far right column shows shares for period from FY2006-FY2015.
+
+ 
+ 
+ 
+ 
+
+ Recent Appropriations History
+
+ Since 2005, the Energy and Water Development (E&W) appropriations bill 15 has funded all DOE programs, including those operated by OE. 16 The office mainly conducts R&D, which is often performed in partnership with industry. OE administers a wide range of R&D programs, each with its own set of goals and objectives.
+
+ Since FY2011, DOE has requested sizeable increases in spending each year, but Congress did not significantly boost spending until FY2016. Table 1 , below, shows the recent pattern of OE requests and final appropriation levels.
+
+ 
+ 
+ Table 1. OE Requests and Final Appropriations, FY2011–FY2016
+
+ ($ millions, current)
+
+ 
+
+ 
+ 
+ 
+ Fiscal Year
+
+ 
+ 
+ Request
+
+ 
+ 
+ Final Appropriation
+
+ 
+ 
+ 
+ 
+ FY2011
+
+ 
+ 
+ $186
+
+ 
+ 
+ $141
+
+ 
+ 
+ 
+ 
+ FY2012
+
+ 
+ 
+ $238
+
+ 
+ 
+ $139
+
+ 
+ 
+ 
+ 
+ FY2013
+
+ 
+ 
+ $143
+
+ 
+ 
+ $132
+
+ 
+ 
+ 
+ 
+ FY2014
+
+ 
+ 
+ $169
+
+ 
+ 
+ $147
+
+ 
+ 
+ 
+ 
+ FY2015
+
+ 
+ 
+ $180
+
+ 
+ 
+ $147
+
+ 
+ 
+ 
+ 
+ FY2016
+
+ 
+ 
+ $270
+
+ 
+ 
+ $206
+
+ 
+ 
+ 
+ 
+ Source: DOE Budget Requests, FY2011 through FY2016; and personal communication with Yulia Korzh, OE, February 8, 2016.
+
+ Note : The FY2016 OE figure was provided in Division D of the Consolidated Appropriations Act, FY2016.
+
+ 
+
+ 
+
+ FY2016 Highlights
+
+ Summary
+
+ DOE presented its FY2016 budget request on February 2, 2015. 17 The request for OE was $270 million, which would have nearly doubled the FY2015 level. 18 As part of that requested increase, DOE proposed to create a new Transformer Resilience and Advanced Components R&D program and a new State Energy Reliability and Assurance grant program. About half of the requested OE increase would have gone to the new grant program. The next largest increases were sought for the Smart Grid and Cybersecurity programs.
+
+ The House Committee on Appropriations reported the Energy and Water Development (E&W) Appropriations Bill, 2016 ( H.R. 2028 ) with a recommendation of $186.65 million (includes $0.9 million rescission) for OE. 19 The $186.6 million figure for OE was adopted in House floor action. 20 Subsequently, the Senate Committee on Appropriations recommended $151.4 million (includes $0.9 million rescission). 21 The congressionally recommended overall amount for DOE drew a veto threat from the Administration mainly for reasons unrelated to OE funding. Subsequently, the E&W bill was incorporated as Division D of the Consolidated Appropriations Act, FY2016 ( H.R. 2029 ). The final enacted version of H.R. 2029 ( P.L. 114-113 , Division D) provided $206 million for OE. 22 
+
+ Congressional Action
+
+ After the Administration issued its FY2016 budget request, Congress held a number of DOE oversight and appropriations hearings. As noted above, further actions were taken in the House and Senate on DOE funding recommendations in the E&W bill, H.R. 2028 . Late in the first session, after lengthy negotiations, the E&W bill was incorporated into H.R. 2029 . The various steps of the congressional process for the FY2016 E&W appropriations are outlined in Table 2 .
+
+ 
+ 
+ Table 2. OE FY2016 Appropriations Chronology
+
+ (Highlights of Committee and Floor Action, with Administration responses)
+
+ 
+
+ 
+ 
+ 
+ Date
+
+ 
+ 
+ Action
+
+ 
+ 
+ 
+ 
+ February 2, 2015
+
+ 
+ 
+ DOE issues FY2016 budget request.
+
+ 
+ 
+ 
+ 
+ February 11, 2015
+
+ 
+ 
+ House Energy and Commerce Committee's Subcommittee on Energy and Power held a hearing on the DOE request.
+
+ 
+ 
+ 
+ 
+ February 12, 2015
+
+ 
+ 
+ Senate Committee on Energy and Natural Resources (SENR) held a hearing on the DOE request.
+
+ 
+ 
+ 
+ 
+ February 26, 2015
+
+ 
+ 
+ House Appropriations Committee's Subcommittee on Energy and Water Appropriations held a hearing on the DOE request.
+
+ 
+ 
+ 
+ 
+ March 25, 2015
+
+ 
+ 
+ Senate Appropriations Committee's Subcommittee on Energy and Water Appropriations held a hearing on the DOE request.
+
+ 
+ 
+ 
+ 
+ April 13, 2015
+
+ 
+ 
+ House Appropriations Committee's Subcommittee on Energy and Water Appropriations released a draft report with recommended funding for FY2016 E&W appropriations bill.
+
+ 
+ 
+ 
+ 
+ April 15, 2015
+
+ 
+ 
+ House Appropriations Committee's Subcommittee on Energy and Water Appropriations held a subcommittee markup.
+
+ 
+ 
+ 
+ 
+ April 21, 2015
+
+ 
+ 
+ House Appropriations Committee issued draft report on FY2016 E&W appropriations bill with recommended funding for FY2016 E&W appropriations bill.
+
+ 
+ 
+ 
+ 
+ April 21, 2015
+
+ 
+ 
+ Office of Management and Budget (OMB) issued a letter to the House Appropriations Committee that expressed the Administration's concerns with the draft E&W appropriations bill.
+
+ 
+ 
+ 
+ 
+ April 22, 2015
+
+ 
+ 
+ House Appropriations Committee held a full committee markup. Several amendments were adopted, none of which affected the provisions for OE.
+
+ 
+ 
+ 
+ 
+ April 24, 2015
+
+ 
+ 
+ House Appropriations Committee issued the E&W appropriations bill ( H.R. 2028 ) and final report ( H.Rept. 114-91 ) with recommended funding for FY2016 E&W appropriations.
+
+ 
+ 
+ 
+ 
+ April 28, 2015
+
+ 
+ 
+ OMB issued a Statement of Administration Policy that strongly opposed House passage of H.R. 2028 .
+
+ 
+ 
+ 
+ 
+ May 1, 2015
+
+ 
+ 
+ House approved H.R. 2028 , without amendments to the committee recommendations for OE.
+
+ 
+ 
+ 
+ 
+ May 21, 2015
+
+ 
+ 
+ Senate Appropriations Committee reported ( S.Rept. 114-54 ) its recommendations for H.R. 2028 .
+
+ 
+ 
+ 
+ 
+ December 17, 2015
+
+ 
+ 
+ House approved H.R. 2029 , Consolidated Appropriations Act, 2016. A modified version of the E&W appropriations bill ( H.R. 2028 ) was included as Division D. The explanatory statement on H.R. 2029 was printed in Congressional Record.
+
+ 
+ 
+ 
+ 
+ December 17, 2015
+
+ 
+ 
+ Senate approved H.R. 2029 .
+
+ 
+ 
+ 
+ 
+ December 18, 2015
+
+ 
+ 
+ President signed H.R. 2029 into law as P.L. 114-113 . The E&W bill was incorporated as Division D.
+
+ 
+ 
+ 
+ 
+ Source: Multiple sources were used.
+
+ 
+
+ 
+
+ Funding Increases
+
+ This section presents the key OE program funding increases enacted and describes some highlights for each of those programs.
+
+ Increases Ranked by Program
+
+ Several programs received a significant funding increase for FY2016. Table 3 shows all program increases in dollar amounts and percentages, relative to FY2015. 
+
+ 
+ 
+ Table 3. OE FY2016 Program Increases, in Rank Order
+
+ ($ millions, FY2016-FY2015 difference)
+
+ 
+
+ 
+ 
+ 
+ Program
+
+ 
+ 
+ Increase
+
+ 
+ 
+ Percent Increase
+
+ 
+ 
+ 
+ 
+ Smart Grid R&D
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $19 .6 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 127% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Cybersecurity (CEDS)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $16 .0 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 35% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Energy Storage
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $8 .5 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 71% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Transformer Resilience (TRAC)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $5 .0 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ — 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Clean Energy Transmission and Reliability (CETR)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $4 .7 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 14% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Infrastructure Security and Energy Restoration (ISER)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $3 .0 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 50% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ National Electricity Delivery (NED)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ $1 .5 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 25% 
+ 
+ 
+ 
+
+ 
+ 
+ 
+ 
+ Source: Congressional Record, Explanatory Statement on Consolidated Appropriations Act, 2016 , December 17, 2015, pp. H10108-H10109, https://www.congress.gov/ crec/ 2015/ 12/ 17/ CREC-2015-12-17-bk2.pdf .
+
+ Notes: Transformer Resilience is a new program for FY2016.
+
+ 
+
+ 
+
+ Highlights of Key Program Increases
+
+ Table 3 shows that the largest OE increases are for smart grid and cybersecurity. 23 A discussion of the planned FY2016 activities in these two areas follows.
+
+ Smart Grid
+
+ Congress provided $5 million more than the nearly $15 million increase sought in the DOE request. The Explanatory Statement for H.R. 2029 ( P.L. 114-113 ) was silent on the focus of the approved $5 million increase over the DOE request.
+
+ The DOE request stated that the "endpoint target" of the smart grid program is "achievement of a self-healing and resilient distribution grid, with integration of networked microgrids and market-based control signals operating under the ADMS [advanced distribution management system] that allows for widespread deployment of distributed renewable and clean energy resources and demand response by 2030." 24 Specifically, the DOE-requested portion of the increase aims to launch two new efforts: ADMS technologies and market-based signal controls (MBCS). 
+ ADMS software will support distribution management and the integration of large amounts of renewable energy. 25 
+
+ MBCS will employ simulation and test cases to improve operational flexibility for increased use of customer and third-party assets (including end-use devices, batteries, distributed generation, solar power, and electric vehicle chargers). 26 
+ Cybersecurity
+
+ Congress provided $10 million more than the DOE requested increase of $6 million. The Explanatory Statement for H.R. 2029 ( P.L. 114-113 ) was silent on the focus of the approved increase over the DOE requested amount.
+
+ The DOE request stressed "the critical need to accelerate and expand efforts to strengthen the energy infrastructure against cyber threats." 27 Specifically, the DOE-requested portion of the increase aimed to establish a "virtual energy sector advanced digital forensics analysis platform." In simpler terms, this project will apply virtual reality visualization technologies to help utilities distinguish between a normal system failure and malicious activity and to help them mitigate any malicious activity. 28 
+
+ Cross-Cutting Initiatives
+
+ The FY2016 request also sought to continue crosscutting programs that coordinate across the department and seek to tap DOE's full capability to effectively and efficiently address national energy, environmental, and national security challenges. OE serves as the central part of the Grid Modernization and Cybersecurity crosscut programs.
+
+ FY2016 Funding Table
+
+ OE operates seven program offices 29 and one administrative office. Each program office has its own set of goals and funding needs. Table 4 shows the funding breakdown by program office.
+
+ 
+ 
+ Table 4. Electricity Delivery and Energy Reliability (OE) Appropriations
+
+ ($ millions)
+
+ 
+
+ 
+ 
+ 
+ Program
+
+ 
+ 
+ FY2013
+Approp.
+
+ 
+ 
+ FY2014
+Approp.
+
+ 
+ 
+ FY2015 Approp.
+
+ 
+ 
+ FY2016 Approp.
+
+ 
+ 
+ FY2016-FY2015
+
+ 
+ 
+ Percent Change
+
+ 
+ 
+ 
+ 
+ Clean Energy Transmission and Reliability (CETR)
+
+ 
+ 
+ 24.1
+
+ 
+ 
+ 32.4
+
+ 
+ 
+ 34.3
+
+ 
+ 
+ 39.0
+
+ 
+ 
+ 4.7
+
+ 
+ 
+ 13.7%
+
+ 
+ 
+ 
+ 
+ Smart Grid R&D
+
+ 
+ 
+ 20.6
+
+ 
+ 
+ 14.6
+
+ 
+ 
+ 15.4
+
+ 
+ 
+ 35.0
+
+ 
+ 
+ 19.6
+
+ 
+ 
+ 127.0%
+
+ 
+ 
+ 
+ 
+ Cybersecurity for Energy Delivery Systems (CEDS)
+
+ 
+ 
+ 30.1
+
+ 
+ 
+ 43.5
+
+ 
+ 
+ 46.0
+
+ 
+ 
+ 62.0
+
+ 
+ 
+ 16.0
+
+ 
+ 
+ 34.8%
+
+ 
+ 
+ 
+ 
+ Energy Storage
+
+ 
+ 
+ 18.9
+
+ 
+ 
+ 15.2
+
+ 
+ 
+ 12.0
+
+ 
+ 
+ 20.5
+
+ 
+ 
+ 8.5
+
+ 
+ 
+ 70.8%
+
+ 
+ 
+ 
+ 
+ Transformer Resilience and Advanced Components (TRAC)
+
+ 
+ 
+ —
+
+ 
+ 
+ —
+
+ 
+ 
+ —
+
+ 
+ 
+ 5.0
+
+ 
+ 
+ 5.0
+
+ 
+ 
+ —
+
+ 
+ 
+ 
+ 
+ National Electricity Delivery (NED)
+
+ 
+ 
+ 6.6
+
+ 
+ 
+ 6.0
+
+ 
+ 
+ 6.0
+
+ 
+ 
+ 7.5
+
+ 
+ 
+ 1.5
+
+ 
+ 
+ 25.0%
+
+ 
+ 
+ 
+ 
+ Infrastructure Security and Energy Restoration (ISER)
+
+ 
+ 
+ 6.1
+
+ 
+ 
+ 8.0
+
+ 
+ 
+ 6.0
+
+ 
+ 
+ 9.0
+
+ 
+ 
+ 3.0
+
+ 
+ 
+ 50.0%
+
+ 
+ 
+ 
+ 
+ Program Direction
+
+ 
+ 
+ 25.6
+
+ 
+ 
+ 27.6
+
+ 
+ 
+ 27.6
+
+ 
+ 
+ 28.0
+
+ 
+ 
+ 0.4
+
+ 
+ 
+ 1.4%
+
+ 
+ 
+ 
+ 
+ Total O E Appropriation 
+
+ 
+ 
+ 132.0
+
+ 
+ 
+ 147.2
+
+ 
+ 
+ 147.3
+
+ 
+ 
+ 206.0
+
+ 
+ 
+ 58.7
+
+ 
+ 
+ 39.9%
+
+ 
+ 
+ 
+ 
+ Source s : DOE Budget Requests for FY2015 and FY2016, vol. 3; and P.L. 114-113 , Division D. Personal communication with Yulia Korzh, OE, February 8, 2016.
+
+ 
+
+ 
+
+ Program Goals and Activities
+
+ For FY2016, the OE request proposed to create one new R&D program (Transformer Resilience and Advanced Components), which was funded, 30 and a new grant program (State Energy Reliability and Assurance), which was not funded. For each of the existing and proposed programs, this section describes goals, objectives, and funding. 
+
+ Clean Energy Transmission and Reliability (CETR) 31 
+
+ The electricity system depends upon the inherent stability of a network of traditional power plants to balance electric power supply and demand. When disruptions occur, power grid operators are usually able to take actions to maintain system stability. However, the basic structure of the system is changing. In particular, the rising levels of wind and solar power generation create resource uncertainty and electric current instability. Both conditions pose a challenge to system stability. Also, a widening range of loads (e.g., backup for rooftop solar) are becoming active participants in the electricity system, which adds more complexity to system models and operations. 32 
+
+ The electricity system must provide key services even during disruptions. A growing number of extreme weather-related events highlight the urgent need for reliable and robust monitoring, modeling, and analytical tools to support both industry operations and governmental emergency response efforts.
+
+ The CETR program aims to improve energy system decisionmaking by fostering the development of system measurement, modeling, and risk analysis. The program is designed to lay the foundation for a modern grid and ensure that elements of risk and uncertainty are properly addressed in decisions about investments to improve energy infrastructure. CETR activities are organized into three R&D subprograms: Transmission Reliability, Advanced Modeling Grid Research, and Energy Systems Risk and Predictive Capability.
+
+ Transmission Reliability Program 
+
+ Existing electric transmission lines were designed to carry electric power from major power plants to urban and industrial load centers. The grid was originally designed mostly for this purpose—not for the market-driven flows of power that it currently serves. Usually mounted on tall metal towers, these lines operate at high voltage and carry high levels of electric current. Competition and market forces are causing the volume of power transactions to grow rapidly. Also, the structure of power generation is changing—due to coal plant retirements, increased use of natural gas-fired generators, and integration of large wind farms. This decentralization of the power generation mix can affect power quality and causes the grid to be used in ways for which it was not originally designed.
+
+ Special electric power sensors, known as synchrophasors, 33 were designed to monitor (measure) electric power flow with high precision and, thus, can reveal much about the health of power systems. The Transmission Reliability program supports the development of cyber-secure grid management applications that employ synchrophasors to enhance the flexibility, reliability, and resilience of the national power system. Spurred by the Northeast blackout of 2003, DOE joined with electric utilities and the North American Electric Reliability Council (NERC) to install synchrophasors throughout the grid. The Recovery Act of 2009 ( P.L. 111-5 ) provided $4.5 billion for the smart grid and grid modernization provisions in EISA (Title 13). 34 A large portion of those funds were used to accelerate the rate of synchrophasor deployment. As the network of these devices expands, the richer 35 data pattern and yield enables the advancement of grid operator tools to detect, track, and analyze grid dynamics and to provide real-time visual monitoring of system conditions. 36 OE expects these advances to lead to automated system controls and to reduce the spread and duration of system outages by 2020.
+
+ In FY2016, OE expects to complete "production-grade" grid operator software applications that will be purchased by utilities. 37 The expanded software applications would be applied to the use of microgrids, energy storage, distributed generation, and electric vehicle charging.
+
+ Advanced Modeling Grid Research Program
+
+ This program conducts research on computer models that underpin energy management systems used by grid operators to plan, monitor, and control the electric system. The goal is to enhance reliability and enable advanced problem mitigation and recovery strategies. Objectives include improved grid resilience to events that otherwise rapidly drive network failures and blackouts; developing predictive capabilities for system anomalies and uncertainties; and integrating models to improve operational planning and enable dynamic reconfiguration of electric system elements to achieve technical and economic objectives. R&D activities focus on data management and the development of computer models and simulations.
+
+ Energy Systems Risk and Predictive Capability (ESRPC) Program
+
+ The need for national capabilities to assess near- and long-term risks to energy infrastructures was illustrated by the massive impacts of Superstorm Sandy (2012), the major hurricanes in 2008 (Gustav and Ike) and in 2005 (Katrina and Rita), and the 2013-2015 western drought and accompanying wildfires. ESRPC's goal is to advance national capability for risk-informed decisionmaking for energy systems. Potential near-term actions include developing strategies to reduce the risk of system interruptions due to extreme weather. Longer-term actions include identifying a portfolio of energy system improvements that could reduce the system-wide risks from weather events.
+
+ For FY2016, ESRPC will focus on developing analytical tools that estimate seasonal and regional extreme weather risks to energy systems that cover large geographic areas. ESPRC's research covers three types of analytic products and predictive models for system planning: (1) real-time information on extent of disruption and likely near- and long-term effects, (2) long-range (five- to eight-year timeframe) risk guidance for investment in national energy infrastructure (e.g., effect of sea level rise on infrastructure in cities), and (3) guidance for nontraditional sources of man-made risk, such as supply chain disruptions.
+
+ Smart Grid R&D 38 
+
+ This program develops technologies, tools, and techniques to modernize the distribution portion of the electric delivery system—power lines, transformers, and other infrastructure—that takes power from the high-voltage transmission system and delivers it to individual businesses and homes. 39 Program goals aim to accommodate rising amounts of customer-owned generation equipment (e.g., solar photovoltaics, PV), support the shift to electric vehicles (EVs), improve resilience to extreme weather events, reduce outages, and enable greater customer control over power use and quality while maintaining electric power affordability.
+
+ Information and communication technologies play a key role in Smart Grid goals to address technical challenges such as rising demand and supply variability, two-way power flow, data management and security, interoperability between new and legacy technologies, and the increasing linkages of distribution and transmission operations.
+
+ Microgrids
+
+ There is a major focus on microgrids, which are localized power grids that can disconnect from the traditional grid to operate independently. 40 Because most power outages occur at the distribution level, microgrid developments can help mitigate grid disturbances and strengthen grid resilience. OE's microgrid program goals are to develop commercial scale microgrid systems (with a capacity less than 10 megawatts) 41 that are capable of reducing outage time of required loads by more than 98%. This would be accomplished at a cost comparable to non-integrated baseline solutions, while reducing emissions by 20% and improving system energy efficiencies by 20% by 2020. 42 
+
+ Advanced Distribution Management Systems (ADMS)
+
+ This program promotes higher performing grids by integrating new assets and information streams with ADMS. An OE report describes these systems:
+
+ ADMS is a software platform that integrates numerous utility systems and provides automated outage restoration and optimization of distribution grid performance. ADMS functions can include automated fault location, isolation, and service restoration (FLISR); conservation voltage reduction; peak demand management; and volt/volt-ampere reactive (volt/VAR) optimization. 43 In effect, an ADMS transitions utilities from paperwork, manual processes, and siloed [separated] software systems to systems with real-time and near-real-time data, automated processes, and integrated systems. 44 
+
+ The report on ADMS notes further that existing mechanisms for the diagnosis of end-of-the-line power problems have yet to employ modern computer capabilities:
+
+ Considering that this is an era in which smart phones and Google Maps are ubiquitous, it may come as a surprise that utilities have very little visibility into their distribution systems. Most systems still rely on breakers to disconnect the lines in the event of a fault, customers to call in to report an outage, and line crews to find the affected circuit and restore power. 45 
+
+ DOE observes that ADMS is a fledgling industry that lacks mature, field-proven vendor products. However, DOE's technology program is working with vendors to help fill that gap. ADMS integration into existing utility operating systems is difficult. Those systems were traditionally custom-built, and evolved with technologies over the course of several decades. Integrating new systems with old—or getting them to "talk" to each other—is complicated and requires an information technology foundation that can support each component of an ADMS. 46 
+
+ In FY2016, the program aims to enhance operational visibility and system asset control. It will start the development of an open source ADMS platform that supports the full range of distribution management applications (such as fault location, service restoration, and operational optimization). Also, the program will begin to develop data analytics for large volumes of grid data needed to validate distribution grid operations.
+
+ Market-Based Control Strategies (MBCS)
+
+ Smart Grid investments will also explore market-based controls in FY2016. The process of coupling market-based control signals with electric distribution operations is generally known as transactive energy. Transactive energy refers to the use of a combination of economic (resource bidding) and physical control techniques to improve grid reliability and efficiency. Regarding the economic aspect, a transactive energy system may lead to collection of data from more nodes (access points on the grid) and, thus, yield finer-grained levels of real-time pricing for each data point. 47 Also, by coordinating the activity of the growing number of distributed energy resources, transactive energy systems can help maintain power system reliability and security while increasing efficiency. 48 Development of the MBCS process is intended to create value to both utilities and customers. This new control paradigm is to enable utilities to balance supply and demand at all levels of the grid, by actively seeking participation of customer-owned and third-party assets in grid services through transparent, competitive forces of demand and supply. 49 The prices or incentives offered by market forces will engage the self-interest of customers and other third parties, and will also serve as a control signal to coordinate operation of their assets with the power grid. Hence, transactive energy will result in greatly increased flexibility needed for maintaining reliability in a low-carbon future, while allowing customers to fully participate in grid operations.
+
+ For FY2016, the program aims to develop simulation tools and to apply validating tools to initial test cases that were funded by the Recovery Act. Transactive approaches will be evaluated to refine controllability, stability limits, and efficacy of operating distributed assets (end-use devices, distributed generation, batteries, PV solar systems, inverters, EV chargers, etc.) and networked communication systems.
+
+ Cybersecurity for Energy Delivery Systems (CEDS) 50 
+
+ Reliable and resilient energy infrastructure is essential to our economy, health and safety, and national security. OE's mission to modernize the electric grid cannot be achieved without the research, development, and integration of secure energy delivery control systems. The energy sector—including electricity, oil, and natural gas—has experienced a dramatic increase in cyber probes, 51 data exfiltration, 52 and malware 53 development for potential attacks. The growing seriousness of these intrusions marks an era of state actor level threats to the nation. The dynamic cyber threat landscape, continuous advances in energy delivery system technologies, and the use of legacy devices in ways not previously envisioned underscore the importance of this continuous transition.
+
+ The Cybersecurity (CEDS) program aims to strengthen the energy infrastructure against current and future cyber threats. The strategic framework for DOE's role is shaped mainly by Presidential Policy Directive 21, Critical Infrastructure Security and Resilienc e . 54 The directive calls on the sector-specific agencies (SSAs) to serve as a day-to-day federal interface for the dynamic prioritization and coordination of various sector-specific activities. As the energy SSA, DOE has the mission, history, and expertise to work with industry to mitigate the risk of cyberattacks on the energy system. To fulfill this responsibility, DOE collaborates with vendors, utility owners, and operators of the electricity and oil and natural gas sectors to strengthen the cybersecurity of critical energy infrastructure.
+
+ OE has the lead role in addressing this DOE responsibility. To meet this requirement the CEDS program conducts cyber risk and incident management activities with four key objectives: (1) accelerate information sharing to enhance situational awareness; (2) expand implementation of the Cybersecurity Capability Maturity Models and Risk Management Process, (3) conduct technology R&D to improve energy reliability and resilience, and (4) exercise and refine the energy sector's cyber incident response capabilities.
+
+ Energy Storage 55 
+
+ The Storage program is designed to develop and demonstrate new and advanced energy storage technologies (e.g., batteries, pumped hydro, flywheels) that will enable the stability, resiliency, and reliability of the future electric utility grid. The program also aims to support increased use of variable renewable energy resources such as wind and solar power generation. The Storage program addresses four challenges identified in the 2013 DOE strategic plan for Grid Energy Storage : 56 cost-competitive energy storage technology, validated reliability and safety, equitable regulatory environment, and industry acceptance.
+
+ The implementation of grid-scale energy storage projects throughout the country is accelerating. Microgrids involving storage are being installed by the military for energy security and by states, including New Jersey and Massachusetts, for emergency preparedness. However, storage technology still needs to make substantial improvements in safety, cycle life, energy density, and cost before becoming fully competitive. R&D activities focus on lowering cost while improving the value, performance, safety, and reliability of stationary energy storage technologies for utility-scale applications.
+
+ Transformer Resilience and Advanced Components (TRAC) 57 
+
+ DOE requested a new funding line to establish this new program in FY2016. The focus is on shielding electric system transformers 58 from a variety of sources that could inflict damage by creating unwanted electric currents. Larger-scale electric utility transformers are vulnerable to certain conditions that can cause a spike in current or voltage. 59 If not protected from such threats, damage to a transformer creates vulnerabilities for other electric system equipment. The proposed program's activities would expand upon initial work funded previously under OE's Infrastructure Security and Emergency Response (ISER) program.
+
+ Transformers and utility substation equipment are often exposed to the elements and are vulnerable to natural and man-made threats. To ensure a reliable and resilient power system, grid components need to be designed and built to withstand the impact of lightning strikes, extreme weather, sun-driven "space weather," 60 electrical disturbances, accidents, equipment failures, and attacks (physical or cyber). Currently, 70% of large power transformers (LPTs) are aged 25 years or more, 60% of circuit breakers are aged 30 years or more, and 70% of transmission lines are aged 25 years or more. The advanced age of these components degrades their ability to withstand physical stresses and may result in higher failure rates. Failure of key components can lead to widespread outages and long recovery times. 61 
+
+ The TRAC program supports grid modernization and resilience by addressing the unique challenges facing transformers and other key components that transport power from generation sites to demand sites. As the hardware of the electric power system evolves to improve resilience and accommodate clean energy sources, R&D and testing is needed to understand the physical impact this evolution has on transformers and other vital grid components and to adapt these components with new technologies.
+
+ The program will analyze the impact of geomagnetically-induced 62 ground currents (GIC) on the power grid and support power electronics development. The TRAC program aims to advance the understanding of the risks and impacts of geomagnetic disturbances (GMD) and electromagnetic pulses (EMP) on large power transformers (LPTs) and other grid components. 63 
+
+ LPTs are the most critical pieces of equipment in the grid. Induced currents from GMD/EMP can overload LPTs, damaging internal components and increasing failure rates. The nature of the vulnerability of different types of transformers to GMD/EMP as well as the predictability of GMD phenomena is not well understood.
+
+ Additionally, increased use of distributed generation will introduce new challenges with reversed power flows, increased harmonics, 64 and larger fault currents that can impact transformers and other grid components. The program will be conducted in close cooperation with equipment manufacturers and electricity asset owners and operators. 65 
+
+ National Electricity Delivery (NED) 66 
+
+ Upon request, this program provides technical and policy expertise to states, regions, and tribes to help develop and implement reliable and affordable electricity infrastructure. NED also authorizes the import and export of electricity, issues permits for cross-border transmission lines, and coordinates federal transmission permitting on federal lands.
+
+ The NED program helps state, regional, local, and tribal entities to develop, refine, and improve their electric power programs, policies, and laws. Also, the program helps these entities develop and implement reliable and affordable electricity infrastructure—including generation, transmission, storage, distribution, and demand-side electricity resources. Through this work, OE aims to strengthen these individual systems, which in turn will strengthen the entire electricity infrastructure.
+
+ At the federal and international level, NED leads governmental actions in authorizing electricity exports and permitting transmission infrastructure construction across international borders. Also, in accordance with the Federal Power Act, NED conducts a triennial national transmission congestion study, 67 and helps coordinate transmission permitting on federal lands.
+
+ Infrastructure Security and Energy Restoration (ISER) 68 
+
+ The ISER program leads national efforts to enhance the reliability, survivability, and resiliency of all national energy infrastructure, including that for electricity, petroleum, and natural gas. The program aims to mitigate consumer energy disruptions and—when energy emergencies occur—to drive an efficient restoration process. ISER conducts activities in cooperation with public and private sector stakeholders, including asset owners and operators. Its key partners include industry and state governments.
+
+ ISER activities are grouped under three main areas: (1) executing effective emergency preparedness, response, and restoration operations; (2) providing reliable energy infrastructure tactical analysis (event analysis) and situational awareness to all stakeholders; and (3) encouraging a risk-based approach to energy system assurance.
+
+ The program provides long-term strategic actions to help secure the national energy supply against a variety of challenges. Those challenges include more frequent, stronger, and more destructive weather events; increasing incidents of physical attacks; potential accidents as a result of aging infrastructure or human error; high-impact, low frequency (HILF) threats such as a catastrophic earthquake or an extended drought; and the continuing cyber threat. These challenges are amplified by the increasing complexity of the energy infrastructure and systems and the interdependencies affecting other critical industries.
+
+ To further strengthen OE's ability to secure the U.S. energy infrastructure, ISER promotes the development of advanced mitigation solutions for "hardening" infrastructure against all hazards, natural and man-made. The program focuses mainly on the hazards that pose the greatest risk to the nation's energy infrastructure, including HILF events and more frequent physical threats such as devastating weather events.
+
+ Upon request, ISER also provides technical assistance to international partners, in collaboration with the U.S. Department of State, to analyze and secure energy assets.
+
+ State Energy Reliability and Assurance Grants 69 
+
+ DOE proposed this grant program as a new activity for FY2016. The $63 million proposal to establish the program was the single largest funding increase that OE requested. The program would have provided grants to states, localities, regions, and tribal entities (or groups of states and tribes). Two distinct grant programs would have been created: Grants for Electricity Transmission, Storage, and Distribution Reliability (ETSDR) and Grants for Energy Assurance. Of the $63 million requested, $27.5 million would have gone to the ETSDR subprogram and $35.5 million would have gone to the Energy Assurance subprogram.
+
+ As a rationale for the program, OE's request noted that states have considerable jurisdiction over the electricity system. DOE observes that states are "excellent test beds for the evolution of the electric power system" and, with federal support, could provide innovative ways to address new trends by allowing the electric sector to provide services that meet goals for reliability, resiliency, efficiency, environmental, and energy assurance. Such activities are in place now, but need to be adequately funded and better integrated within states and across states. DOE says that its long history of technical assistance to states has positioned it to help coordinate those planning processes within states and across state lines.
+
+ Grants for Electricity Transmission, Storage, and Distribution Reliability
+
+ DOE proposed this new program for state energy market and policy design systems to address system interdependencies and scale-up of renewable energy integration. The program was designed to support the grid modernization crosscut initiative. The requested $27.5 million would have funded grants to states and others to develop energy system reliability plans to advance electric reliability planning and integrate the plans with environmental protection (including climate adaptation), climate resiliency, and efficiency infrastructure planning and action. 70 
+
+ Energy Assurance Grants
+
+ The energy assurance planning grants would have provided formula grants to improve the short-term and long-term capacity of state, local, and tribal governments to identify the potential for energy disruptions, quantify the impacts of those disruptions, and develop responsive plans to mitigate the threat of future disruptions. The requested $35.5 million would have been used to update energy assurance plans; require testing, training, and exercises; and ensure that plans and assessments were shared.
+
+ A key DOE rationale for the proposed program was the fact that state and local governments are ultimately responsible for responding to disasters and disruptions. This program was designed for OE to help those governments build and maintain preparedness and assurance capabilities. 71 The program would have financed state, local, and tribal government efforts to enhance resiliency through energy assurance planning and the testing of, training for, and exercising of those plans. 72 This grant program would have been undertaken in cooperation with OE's ISER program, which would have served as a convener of forums for information sharing and coordination of state energy assurance plans with other state and local disaster and emergency response plans, private sector response plans, and the plans of neighboring states.
+
+ Program Direction 73 
+
+ This administrative activity funds the costs associated with the OE workforce, including salaries, benefits, travel, training, building occupancy, information technology services, and other related expenses. The program funding also provides for the costs associated with contractor services that support OE's mission.
+
+ Additional Reports Related to OE Programs, Funding, and Policy
+
+ For additional background on selected OE programs, funding, and policy aspects, see the following CRS reports.
+
+ CRS Report R43567, Energy and Water Development: FY2015 Appropriations , coordinated by [author name scrubbed]
+
+ CRS Report RS22858, Renewable Energy R&D Funding History: A Comparison with Funding for Nuclear Energy, Fossil Energy, and Energy Efficiency R&D , by [author name scrubbed]
+
+ CRS Report R41886, The Smart Grid and Cybersecurity—Regulatory Policy and Issues , by [author name scrubbed]
+
+ CRS Report R43966, Energy and Water Development: FY2016 Appropriations , by [author name scrubbed]
+
+ CRS Report R43604, Physical Security of the U.S. Power Grid: High-Voltage Transformer Substations , by [author name scrubbed]
+
+ CRS Insight IN10425, Electric Grid Physical Security: Recent Legislation , by [author name scrubbed]
+
+ 
+
+ 
+ Author Contact Information
+ 
+ [author name scrubbed], Specialist in Energy Policy
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ The largest assets are energy production facilities, pipelines, and transmission lines.
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ This mission is cited in Strategic Objective 2 of the DOE Strategic Plan.
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ DOE, FY2016 Budget in Brief , p. 32.
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ Prior to that time, OE programs had been managed as a minor program office under the Office of the Secretary/Office of Energy Efficiency and Renewable Energy (EERE).
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ DOE, Q T R 2 , Summary and Conclusions, p. 416, http://energy.gov/sites/prod/files/2015/09/f26/Quadrennial-Technology-Review-2015_0.pdf .
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ QER 2 , p. 425. 
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ DOE, Grid Modernization Multi - Year Program Plan (MYPP) , November 2015 (released January 14, 2016), Executive Summary, p. xi, http://energy.gov/sites/prod/files/2016/01/f28/Grid%20Modernization%20Multi-Year%20Program%20Plan.pdf .
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ DOE, Grid Modernization Multi - Year Program Plan , November 2015, p. 12.
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ DOE, MYPP, Executive Summary , p. xiv-xv.
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ DOE, MYPP , November 2015, Executive Summary, p. xi.
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ From FY1948 through FY1977 the federal government provided an extensive amount of R&D support for fossil energy and nuclear power technologies. The energy crises of the 1970s spurred the federal government to expand its R&D programs to include renewable (wind, solar, biomass, geothermal, hydro) energy and energy efficiency technologies. In real (constant dollar) terms, funding support for all four of the main energy technologies skyrocketed during the 1970s to a combined peak in FY1979. Funding then dropped steadily, leveling off during the late 1990s. Since then, funding has increased gradually—except that the Recovery Act provided a one-year spike in FY2009. More details about DOE—and earlier (pre-1978)—spending for energy technologies are available in CRS Report RS22858, Renewable Energy R&D Funding History: A Comparison with Funding for Nuclear Energy, Fossil Energy, and Energy Efficiency R&D , by [author name scrubbed].
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ The Recovery Act funding supported smart grid activities that were authorized primarily by Title 13 of the Energy Independence and Security Act of 2007 (EISA, P.L. 110-14 ).
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ A synchrophasor is an advanced power monitoring and control device. It is also referred to as a phasor measurement unit (PMU).
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ DOE, OE, Synchrophasor Technologies and the Deployment in the Recovery Act Smart Grid Programs , August 2013, https://www.smartgrid.gov/files/Synchrophasor_Report_08_09_2013_DOE_2_version_0.pdf . For a brief discussion about synchrophasors, see the section below on Clean Energy Transmission and Reliability. 
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ For an overview of the FY2016 E&W appropriations process, see CRS Report R43966, Energy and Water Development: FY2016 Appropriations , by [author name scrubbed].
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ Prior to 2005, DOE programs were supported partly by the E&W bill and partly by the Interior appropriations bill.
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ A video replay of Secretary Moniz's verbal presentation of the DOE request is available at http://energy.gov/articles/energy-department-presents-fy16-budget-request . The portion on energy programs, including EERE, begins at about nine minutes into the video recording. Also, the printed text of the Secretary's verbal presentation is available at http://energy.gov/articles/secretary-monizs-remarks-presenting-department-s-fy-2016-budget-request-delivered .
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ At the same time—to offset a large overall requested increase for DOE funding—the Administration sought a revenue offset derived from a proposal to repeal about $4 billion in fossil fuel tax incentives.
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ See H.Rept. 114-91 , Energy and Water Development Appropriations Bill, 201 6, p. 89, April 24, 2015.
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ H.R. 2028 as engrossed in House (passed House), p. 21.
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ S.Rept. 114-54 , Energy and Water Development Appropriations Bill, 2016 , p. 75, May 21, 2015.
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ The text of the enacted bill is available at https://www.congress.gov/114/bills/hr2029/BILLS-114hr2029enr.pdf .
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ For more about smart grid and cybersecurity issues, see CRS Report R41886, The Smart Grid and Cybersecurity—Regulatory Policy and Issues , by [author name scrubbed].
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ DOE, FY2016 Budget Request (vol. 3) , p. 359, http://energy.gov/sites/prod/files/2015/02/f19/FY2016BudgetVolume3_7.pdf .
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ For more about ADMS, see the section on Smart Grid R&D, p. 14.
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ DOE, FY2016 Budget Request (vol. 3) , pp. 352-353. For more about MBCS, see " Smart Grid R&D ," below.
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ DOE, FY2016 Budget Request (vol. 3) , p. 362.
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ DOE, FY2016 Budget Request (vol. 3) , pp. 363-365.
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ For FY2016, Congress approved funding to support DOE's request to establish a new program, Transformer Resilience and Advanced Components (TRAC).
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ TRAC was funded at $5 million, which was one-half of the requested amount.
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ The CETR program is covered in DOE, FY2016 Budget Request , pp. 333-345. Note: This page reference is for DOE's PDF file available on the web—the printed version has slightly different pagination.
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ Improved capacity for transmission of renewable energy power generation could be important to implementing the renewable energy aspects of the Environmental Protection Agency's (EPA's) Clean Power Plan.
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ These monitoring devices, also called phasor measurement units (PMUs), measure the instantaneous voltage, current, and frequency at specific locations in an electricity transmission system—usually at transmission substations. These data measurements represent the "heart-beat" and health of the power system. Voltage and current are parameters that characterize the delivery of electric power from generation plants to end-user loads, while frequency is the key indicator of the balance between electric load and generation. Thus, keeping frequency very close to 60 Hertz (cycles per second) is key to ensuring the proper operation of the power system and its reliability. For more details, see DOE, OE, Synchrophasor Technologies and their Deployment in the Recovery Act Smart Grid Program , 2013, p. 2, https://www.smartgrid.gov/sites/default/files/doc/files/Synchrophasor%20Report%2008%2009%202013%20DOE%20%282%29%20version_0.pdf .
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ See conference report, H.Rept. 111-16 , p. 25.
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ In this use, the term "richer" means increased frequency and amount of data made available for real-time monitoring.
+
+ 
+ 
+ 
+ 36 .
+ 
+ 
+ While the richer data stream improves the capability of industrial control (IC) systems, the higher speed of the automated data flow may also increase cybersecurity concerns. For more on this aspect, see CRS Report R43989, Cybersecurity Issues for the Bulk Power System , by [author name scrubbed].
+
+ 
+ 
+ 
+ 37 .
+ 
+ 
+ NERC provides a more detailed description of "production-grade" software. See NERC, Real-Time Application of Synchrophasors for Improving Reliability , October 2010, p. 21, http://www.nerc.com/docs/oc/rapirtf/RAPIR%20final%20101710.pdf .
+
+ 
+ 
+ 
+ 38 .
+ 
+ 
+ The Smart Grid program is covered in DOE, FY2016 Budget Request, pp. 346-353. For more about smart grid issues, see CRS Report R41886, The Smart Grid and Cybersecurity—Regulatory Policy and Issues , by [author name scrubbed]. 
+
+ 
+ 
+ 
+ 39 .
+ 
+ 
+ The smaller medium- and low-voltage lines of the electric distribution system cover more distance than high voltage transmission lines.
+
+ 
+ 
+ 
+ 40 .
+ 
+ 
+ The Smart Grid R&D Program adopts the definition of the microgrid by the Microgrid Exchange Group (MEG); namely, "A microgrid is a group of interconnected loads and distributed energy resources within clearly defined electrical boundaries that acts as a single controllable entity with respect to the grid. A microgrid can connect and disconnect from the grid to enable it to operate in both grid-connected or island-mode." DOE, OE, Summary Report: 2012 DOE Microgrid Workshop , p. 1, http://energy.gov/sites/prod/files/2012%20Microgrid%20Workshop%20Report%2009102012.pdf .
+
+ 
+ 
+ 
+ 41 .
+ 
+ 
+ One megawatt (MW) represents 1 million watts, or 1,000 kilowatts.
+
+ 
+ 
+ 
+ 42 .
+ 
+ 
+ DOE, OE, Summary Report: 2012 DOE Microgrid Workshop , p. 1. Also, see DOE, Microgrid Activities , http://energy.gov/oe/services/technology-development/smart-grid/role-microgrids-helping-advance-nation-s-energy-syst-0 .
+
+ 
+ 
+ 
+ 43 .
+ 
+ 
+ Volt/VAR optimization reduces electric line losses and increases grid efficiency. These technologies have advanced to include Volt/Volt-Ampere Reactive Optimization (VVO) sensors, equipment and software capable of reducing overall distribution line losses by 2%–5% through tight control of voltage and current fluctuations. See National Electrical Manufacturers Association (NEMA), Volt/VAR Optimization Improves Grid Efficiency , https://www.nema.org/Policy/Energy/Smartgrid/Documents/VoltVAR-Optimazation-Improves%20Grid-Efficiency.pdf .
+
+ 
+ 
+ 
+ 44 .
+ 
+ 
+ DOE, OE, Voices of Experience: Insights into Advanced Distribution Management Systems , (DOE/GO-OT-6A42-63689) February 2015, p. 3, https://www.smartgrid.gov/document/insights_advanced_distribution_management_systems .
+
+ 
+ 
+ 
+ 45 .
+ 
+ 
+ OE, Voices of Experience , p. 3.
+
+ 
+ 
+ 
+ 46 .
+ 
+ 
+ OE, Voices of Experience , p. 6.
+
+ 
+ 
+ 
+ 47 .
+ 
+ 
+ This may result in a need for regulations keyed to a more dynamic energy market. 
+
+ 
+ 
+ 
+ 48 .
+ 
+ 
+ For more about transactive energy, see DOE, Gridwise Architecture Council, Gridwise Transactive Energy Framework (version 1.0) , January 2015, http://www.gridwiseac.org/pdfs/te_framework_report_pnnl-22946.pdf .
+
+ 
+ 
+ 
+ 49 .
+ 
+ 
+ One might think of this process as a sort of "supply-response" mechanism, as a parallel concept to the growing practice of demand-response programs.
+
+ 
+ 
+ 
+ 50 .
+ 
+ 
+ The Cybersecurity program is covered in DOE, FY2016 Budget Request, pp. 354-360. For more about cybersecurity issues, see CRS Report R41886, The Smart Grid and Cybersecurity—Regulatory Policy and Issues , by [author name scrubbed]. 
+
+ 
+ 
+ 
+ 51 .
+ 
+ 
+ A probe is an action taken or an object used for the purpose of learning something about the state of the network.
+
+ 
+ 
+ 
+ 52 .
+ 
+ 
+ Data exfiltration is the unauthorized transfer of sensitive information from a target's network to a location which a threat actor controls.
+
+ 
+ 
+ 
+ 53 .
+ 
+ 
+ Malware is a short-hand term for malicious software. It is any software used to disrupt computer operation, gather sensitive information, or gain access to private computer systems.
+
+ 
+ 
+ 
+ 54 .
+ 
+ 
+ The CEDS program structure also aligns with guidance provided in the 2011 Roadmap to Achieve Energy Delivery Systems Cybersecurity , prepared by the Energy Sector Control Systems Working Group of the Critical Infrastructure Partnership Advisory Council, September 2011, http://energy.gov/sites/prod/files/Energy%20Delivery%20Systems%20Cybersecurity%20Roadmap_finalweb.pdf .
+
+ 
+ 
+ 
+ 55 .
+ 
+ 
+ The Energy Storage program is covered in DOE, FY2016 Budget Request , pp. 361-366. 
+
+ 
+ 
+ 
+ 56 .
+ 
+ 
+ DOE, Grid Energy Storage , December 2013, http://energy.gov/oe/downloads/grid-energy-storage-december-2013 .
+
+ 
+ 
+ 
+ 57 .
+ 
+ 
+ The Transformer Resilience and Advanced Components program is covered in DOE, FY2016 Budget Request , pp. 367-369. 
+
+ 
+ 
+ 
+ 58 .
+ 
+ 
+ Most people have seen the round, barrel-shaped objects mounted on neighborhood electric utility poles. Those objects are transformers that reduce (step down) the current and voltage on those lines to a lower level that is appropriate for the equipment used in homes, institutions, and commercial buildings. Another familiar example of a transformer is the power adapter that often comes packaged with various consumer electronic devices such as laptop computers and computer monitors. These devices reduce, or otherwise adapt, household current and voltage to levels that won't damage sensitive electronic devices. The TRAC program focuses on much larger, grid-scale transformers.
+
+ 
+ 
+ 
+ 59 .
+ 
+ 
+ For more about transformer security issues, see CRS Report R43604, Physical Security of the U.S. Power Grid: High-Voltage Transformer Substations , by [author name scrubbed]. For more about legislation on this issue, see CRS Insight IN10425, Electric Grid Physical Security: Recent Legislation , by [author name scrubbed]. 
+
+ 
+ 
+ 
+ 60 .
+ 
+ 
+ Coronal mass ejections (CMEs) appear to pose the most serious threats to the power grid. A CME occurs when the sun ejects charged particles that interact with Earth's magnetic field, creating a "magnetic storm" that can cause long-lasting blackouts of the power grid. Scientists note that "[t]he sudden increase in power can damage sensitive electronic equipment. Power transformers can overload, causing long-lasting blackouts. Long metal structures like oil and gas pipelines can carry currents, which can enhance their corrosion over time.... " See space.com, "Space Weather: Sunspots, Solar Flares and Coronal Mass Ejections," http://www.space.com/11506-space-weather-sunspots-solar-flares-coronal-mass-ejections.html .
+
+ 
+ 
+ 
+ 61 .
+ 
+ 
+ For instance, a single LPT that is damaged can temporarily disrupt power to 500,000 homes and, as a typically custom-designed piece of equipment weighing over 100 tons, it could take up to two years to manufacture and deliver a replacement. DOE, FY2016 Budget Request , p. 367. For more about LPTs, see DOE, Large Power Transformers and the U.S. Electric Grid, 2012, http://energy.gov/sites/prod/files/Large%20Power%20Transformer%20Study%20-%20June%202012_0.pdf .
+
+ 
+ 
+ 
+ 62 .
+ 
+ 
+ These currents are caused by coronal mass ejections from the sun. This is a more intense experience of the same phenomenon that causes the aurora borealis, or "northern lights."
+
+ 
+ 
+ 
+ 63 .
+ 
+ 
+ For more on this aspect, see CRS Congressional Distribution Memo, Space Weather and EMP Threat s to the Electric G rid , by [author name scrubbed].
+
+ 
+ 
+ 
+ 64 .
+ 
+ 
+ Harmonics are a distortion of the normal electrical current waveform, generally transmitted by nonlinear loads. Switch-mode power supplies (SMPS), variable speed motors and drives, photocopiers, personal computers, laser printers, fax machines, battery chargers and uninterruptible power supplies (UPSs) are examples of nonlinear loads.
+
+ 
+ 
+ 
+ 65 .
+ 
+ 
+ For more on this aspect, see CRS Report R43604, Physical Security of the U.S. Power Grid: High-Voltage Transformer Substations , by [author name scrubbed].
+
+ 
+ 
+ 
+ 66 .
+ 
+ 
+ The National Electricity Delivery program is covered in DOE, FY2016 Budget Request , pp. 370-376. 
+
+ 
+ 
+ 
+ 67 .
+ 
+ 
+ The most recent triennial national transmission congestion study was published in 2015. See, DOE, National Electric Transmission Congestion Study, September 2015, http://www.energy.gov/sites/prod/files/2015/09/f26/2015%20National%20Electric%20Transmission%20Congestion%20Study_0.pdf .
+
+ 
+ 
+ 
+ 68 .
+ 
+ 
+ The Infrastructure Security and Energy Restoration program is covered in DOE, FY2016 Budget Request , pp. 377-386. 
+
+ 
+ 
+ 
+ 69 .
+ 
+ 
+ The State Energy Reliability and Assurance Grants program is covered in DOE, FY2016 Budget Request , pp. 387-391. 
+
+ 
+ 
+ 
+ 70 .
+ 
+ 
+ More specifically, the ETSDR program would have provided planning grants to promote long-term electricity system reliability planning, including (1) integrating plans and actions for transmission, storage, and distribution (TSD) reliability, climate resiliency, and environmental compliance, (2) plans for the evolving interdependencies of electricity, natural gas and water systems; (3) regulatory reforms to enable investments in TSD that address the challenges of the evolving system, including reforms for distributed generation and energy efficiency; (4) plans for upgrades of infrastructure to make it more resilient to climate change and extreme weather; (5) design incentives and cost recovery mechanisms for reliability and climate resiliency investments; and (6) foster within-state and multi-state cooperation.
+
+ 
+ 
+ 
+ 71 .
+ 
+ 
+ The goal of state and local energy assurance planning is to achieve a robust, secure, and reliable energy infrastructure that is also resilient—better able to withstand catastrophic events, able to restore services rapidly in the event of any disaster, and designed to diminish future vulnerabilities.
+
+ 
+ 
+ 
+ 72 .
+ 
+ 
+ Such plans would have been designed to include (1) energy emergency procedures that address multiple lifeline (e.g., food, housing, and shelter) sectors, (2) integration with state energy plans, state hazard mitigation plans, and other policies, and (3) mechanisms to track the duration, response, restoration and recovery time of energy supply disruption events. 
+
+ 
+ 
+ 
+ 73 .
+ 
+ 
+ The Program Direction activity is covered in DOE, FY2016 Budget Request , pp. 392-395.
\ No newline at end of file
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@@ -0,0 +1,1745 @@
+Treasury Department Appropriations, FY2016
+
+ January 19, 2016
+ (R44346)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ The Department of the Treasury 
+
+ Organizational Structure and Functions 
+
+ Treasury Appropriations Accounts 
+
+ Departmental Offices (DO) 
+
+ Department-wide Systems and Capital Investments Program (DSCIP) 
+
+ Office of Inspector General (OIG) 
+
+ Treasury Inspector General for Tax Administration (TIGTA) 
+
+ Special Inspector General for the Troubled Asset Relief Program (SIGTARP) 
+
+ Financial Crimes Enforcement Network (FinCEN) 
+
+ Bureau of the Fiscal Service (BFS) 
+
+ Alcohol and Tobacco Tax and Trade Bureau (ATTB) 
+
+ Community Development Financial Institutions Fund (CDFIF) 
+
+ Internal Revenue Service (IRS) 
+
+ FY2016 Treasury Appropriation Accounts: Current Status and Issues for Congress 
+
+ Departmental Offices 
+
+ Departmentwide Systems and Capital Investments 
+
+ Office of Inspector General 
+
+ Office of the Special Inspector General for the Troubled Asset Relief Program 
+
+ Treasury Inspector General for Tax Administration 
+
+ Community Development Financial Institutions Fund 
+
+ Financial Crimes Enforcement Network 
+
+ Alcohol and Tobacco Tax and Trade Bureau 
+
+ Bureau of the Fiscal Service 
+
+ Treasury Forfeiture Fund (TFF) 
+
+ Internal Revenue Service 
+
+ 
+ 
+ Tables
+
+ 
+ Table 1. Department of the Treasury Appropriations, FY2015-FY2016 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ At its most basic level of organization, the Treasury Department is a collection of departmental offices and operating bureaus. The bureaus as a whole account for 95% of Treasury's budget and workforce. Most bureaus and offices are funded through annual appropriations. 
+
+ Treasury appropriations were distributed among 10 accounts in FY2015: (1) Departmental Offices (DO), (2) Departmentwide Systems and Capital Investments Program (DSCIP), (3) Office of Inspector General (OIG), (4) Treasury Inspector General for Tax Administration (TIGTA), (5) Special Inspector General for the Troubled Asset Relief Program (SIGTARP), (6) Financial Crimes Enforcement Network (FinCEN), (7) Bureau of the Fiscal Service (BFS), (8) Alcohol and Tobacco Tax and Trade Bureau (ATTB), (9) Community Development Financial Institutions Fund (CDFIF), and (10) the Internal Revenue Service (IRS). 
+
+ The President's budget request for FY2016 included $13.456 billion in appropriations for the Treasury Department, including a rescission of $875 million for the Treasury Forfeiture Fund (TFF). Of the requested amount, $12.931 billion would go to the IRS; $364 million to the BFS; $332 million to DO; $233.5 million to CDFIF; $167 million to TIGTA; $113 million to FinCEN; $101 million to ATTB; $41 million to SIGTARP; $35 million to OIG; and $11 million to DSCIP.
+
+ In early July 2015, the House Appropriations Committee reported a bill ( H.R. 2995 ) that provided appropriations for the Treasury Department and several other agencies in FY2016. Under the measure, Treasury would have received $10.758 billion in appropriations, including a rescission of $721 million from the TFF; this amount was $764 million less than the amount enacted for FY2015 and $2.698 billion less than the budget request. 
+
+ Later the same month, the Senate Appropriations Committee also reported a bill ( S. 1910 ) to fund Treasury and the same other agencies in FY2016. Under the measure, Treasury would have received $11.139 billion in appropriations, including a rescission of $700 million from the TFF. This amount was $383 million less than the amount enacted for FY2015 and $2.317 billion less than the budget request. 
+
+ The House and Senate agreed in mid-December 2015 on an omnibus appropriations measure (Consolidated Appropriations Act, 2016, P.L. 114-113 ) for FY2016 that included funding for the Treasury Department. Under the act, Treasury received $11.942 billion in appropriations, or $420 million more than the amount enacted for FY2015 but $1.514 billion less than the budget request.
+
+ The three FY2016 budget proposals for Treasury raised several issues for Congress. One concerned the status of funding for the Office of Terrorism and Financial Intelligence (TFI): H.R. 2995 as reported would have created a separate appropriations account for the TFF, whereas both the Administration's budget request and S. 1910 as reported proposed combining funding for the Office with overall DO funding. Another issue was the future status of two CDFIF programs: the Healthy Food Initiative and the Bank Enterprise Award Program. The budget request included funding for the former but no funding for the latter, but S. 1910 and H.R. 2995 would have funded the latter without funding the former. 
+
+ Proposed funding for the IRS in FY2016 raised three additional issues: (1) the potential impact of the three proposals on taxpayer service and tax law enforcement, (2) the advantages and disadvantages of using discretionary funding cap adjustments under the Balanced Budget Act of 2011 to increase funding for IRS enforcement activities, and (3) the implications of the current budget scoring convention of disregarding the net revenue effect of agency administrative programs for the size of the IRS budget.
+
+ 
+ 
+ Treasury Department Appropriations, FY2016
+
+ The Department of the Treasury
+
+ This report examines FY2016 appropriations for the Treasury Department and its operating bureaus, including the Internal Revenue Service (IRS). More specifically, it describes the President's budget request for Treasury in FY2016 and the current status of legislation in the House and Senate to fund the agency. In addition, the report discusses policy issues raised by the budget request and the appropriations bills in the House and Senate.
+
+ The Treasury Department performs a variety of critical functions. Foremost among them are
+ protecting the nation's financial system against illegal activities, such as money laundering and terrorist financing; 
+
+ collecting tax revenue and enforcing tax laws;
+
+ managing and accounting for the federal debt; 
+
+ administering the federal government's finances; 
+
+ regulating certain financial institutions; and 
+
+ producing and distributing coins and currency.
+ Organizational Structure and Functions
+
+ At its most basic level of organization, the Treasury Department is a collection of departmental offices and operating bureaus. In general, departmental offices formulate and implement policy initiatives and manage Treasury's day-to-day operations, while operating bureaus handle specific tasks and duties assigned to Treasury, mainly as a result of statutory mandates. In the past decade, the bureaus have accounted for more than 95% of the Treasury Department's funding and workforce.
+
+ With one exception, the bureaus and offices can be divided into those engaged in financial management and regulation and those engaged in law enforcement. In recent years, the Comptroller of the Currency, U.S. Mint, Bureau of Engraving and Printing, Bureau of the Fiscal Service, and Community Development Financial Institutions Fund have been involved in the management of the federal government's finances or the supervision and regulation of key elements of the U.S. financial system. By contrast, law enforcement has been central to the duties handled by the Alcohol and Tobacco Tax and Trade Bureau, Financial Crimes Enforcement Network, and the Treasury Forfeiture Fund. The advent of the Department of Homeland Security in 2002 sharply curtailed Treasury's direct involvement in law enforcement. Arguably, the exception to this simple dichotomy is the IRS, whose main responsibilities encompass both the collection of tax revenue and the enforcement of tax laws and regulations.
+
+ The operating budgets for most Treasury bureaus and offices are funded largely through annual discretionary appropriations. This is the case for the IRS, Bureau of the Fiscal Service, Financial Crimes Enforcement Network, Alcohol and Tobacco Tax and Trade Bureau, Office of the Inspector General, Treasury Inspector General for Tax Administration, Special Inspector General for the Troubled Asset Relief Program, and Community Development Financial Institutions Fund. However, funding for the Treasury Franchise Fund, the U.S. Mint, the Bureau of Engraving and Printing, and the Office of the Comptroller of the Currency comes exclusively from the fees they receive for the services and products they provide to the public and other government agencies.
+
+ Treasury Appropriations Accounts
+
+ Treasury appropriations are distributed among 10 accounts, which are described below.
+
+ Departmental Offices (DO)
+
+ The Departmental Offices account covers the salaries and other expenses of offices in Treasury that formulate and implement policies dealing with domestic and international finance, terrorist financing and other financial crimes, taxation, and the state of the domestic economy. Funding is also provided through DO for the Treasury's financial and personnel management, procurement operations, and information and telecommunications systems.
+
+ Department-wide Systems and Capital Investments Program (DSCIP)
+
+ The Department-wide Systems and Capital Investments Program account pays for investments in new technology and capital improvements aimed at modernizing Treasury's administrative processes and increasing the efficiency of its overall operations.
+
+ Office of Inspector General (OIG)
+
+ The Office of Inspector General account covers the salaries and other expenses related to the audits and investigations conducted by OIG staff. These evaluations are intended to improve the efficiency and effectiveness of Treasury's operations and programs; prevent waste, fraud, and abuse; and inform the Treasury Secretary and Congress about problems or shortcomings in those activities.
+
+ Treasury Inspector General for Tax Administration (TIGTA)
+
+ The Treasury Inspector General for Tax Administration account pays for salaries and other expenses related to the audits and investigations conducted by TIGTA staff. These evaluations focus primarily on the efficiency and effectiveness of IRS programs and operations. TIGTA's investigations are also intended to deter or prevent fraud and waste in IRS programs and operations, and to recommend changes in those activities to solve problems or remedy deficiencies.
+
+ Special Inspector General for the Troubled Asset Relief Program (SIGTARP)
+
+ The Special Inspector General for the Troubled Asset Relief Program account pays the salaries and other expenses related to the audits and investigations into the management and effectiveness of TARP conducted by SIGTARP staff. The office was established by the same law that created TARP: the Emergency Economic Stabilization Act ( P.L. 110-343 ). 1 
+
+ Financial Crimes Enforcement Network (FinCEN)
+
+ The Financial Crimes Enforcement Network account covers the salaries and other expenses related to the activities of FinCEN, whose main responsibility is to protect the domestic financial system from illicit uses, such as money laundering and terrorist financing. The statutory basis for this role is the Bank Secrecy Act (BSA, P.L. 91-508). FinCEN administers key provisions of the act by developing and implementing regulations and other guidance and working with private financial institutions and eight federal agencies to ensure the financial industry complies with the BSA's strict reporting requirements for financial transactions.
+
+ Bureau of the Fiscal Service (BFS)
+
+ The Bureau of the Fiscal Service account funds two operations functions that up until FY2014 were handled by two separate bureaus with separate appropriations accounts: the Financial Management Service and the Bureau of Public Debt. As a result of a consolidation of the two bureaus that began in FY2015, the BFS account covers the salaries and other expenses related to developing and implementing payment policies and procedures for federal agencies, collecting debts owed to those agencies and state governments, and providing financial accounting, reporting, and financing services for the federal government and its agents. In addition, the BFS account covers the salaries and other expenses related to the federal government's public debt operations and the sale of U.S. bonds
+
+ Alcohol and Tobacco Tax and Trade Bureau (ATTB)
+
+ The Alcohol and Tobacco Tax and Trade Bureau account pays for the salaries and other expenses related to the activities of ATTB, which was established by the Homeland Security Act of 2002 ( P.L. 107-296 ) . ATTB enforces certain laws governing the domestic sale and production of alcohol and tobacco products. It also has jurisdiction over the federal consumer safety laws governing the use of alcohol and tobacco products.
+
+ Community Development Financial Institutions Fund (CDFIF)
+
+ The Community Development Financial Institutions Fund account funds the activities of community development financial institutions (CDFIs). These institutions, which include community development banks, credit unions, and venture capital funds, provide grants, loans, and equity investments for affordable housing projects, small businesses, and community development projects in eligible areas. In addition, the CDFIF administers the Bank Enterprise Award (BEA) program and the New Markets tax credit. Since its creation in 1994, the CDFIF has awarded at least $2.1 billion to community development financial institutions, community development entities (CDEs), and depository institutions insured by the Federal Deposit Insurance Corporation through the CDFI Program; the Native American CDFI Assistance Program; and the BEA program. 2 In addition, the fund has allocated $40 billion in New Markets tax credits to CDEs since the credit was created in 2000.
+
+ Internal Revenue Service (IRS)
+
+ The Internal Revenue Service account covers the salaries and other expenses related to the enforcement of federal tax laws and the collection of revenue. Two critical components of the IRS's operations and programs are the services it offers taxpayers to help them understand and meet their tax obligations, and the measures it takes to improve voluntary taxpayer compliance and punish those who violate the law. Some appropriated funds are used to develop or upgrade business operations and information systems, as part of an ongoing effort by the IRS to improve the effectiveness and efficiency of taxpayer services and enforcement.
+
+ Table 1 shows the enacted appropriations for Treasury's accounts in FY2015, the President's FY2016 request, and the amounts recommended for FY2016 by the House and the Senate Appropriations Committees.
+
+ 
+ 
+ Table 1. Department of the Treasury Appropriations, FY2015-FY2016
+
+ (in millions of dollars)
+
+ 
+
+ 
+ 
+ 
+ Appropriation Account
+
+ 
+ 
+ FY2015 Enacted
+
+ 
+ 
+ FY201 6 Resident's Request 
+
+ 
+ 
+ H.R. 2995 
+
+ 
+ 
+ S. 1910 
+
+ 
+ 
+ FY2016 Enacted
+
+ 
+ 
+ 
+ 
+ Departmental Offices (Salaries and Expenses)
+
+ 
+ 
+ $210
+
+ 
+ 
+ $332
+
+ 
+ 
+ $200
+
+ 
+ 
+ $326
+
+ 
+ 
+ $222.5
+
+ 
+ 
+ 
+ 
+ Department-wide Systems and Capital Investments
+
+ 
+ 
+ 3
+
+ 
+ 
+ 11
+
+ 
+ 
+ —
+
+ 
+ 
+ 5
+
+ 
+ 
+ 5
+
+ 
+ 
+ 
+ 
+ Office of Terrorism and Financial Intelligence
+
+ 
+ 
+ 112.5
+
+ 
+ 
+ —
+
+ 
+ 
+ 116
+
+ 
+ 
+ —
+
+ 
+ 
+ 117
+
+ 
+ 
+ 
+ 
+ Office of Inspector General
+
+ 
+ 
+ 35
+
+ 
+ 
+ 35
+
+ 
+ 
+ 35
+
+ 
+ 
+ 35
+
+ 
+ 
+ 35
+
+ 
+ 
+ 
+ 
+ Treasury Inspector General for Tax Administration
+
+ 
+ 
+ 158
+
+ 
+ 
+ 167
+
+ 
+ 
+ 167
+
+ 
+ 
+ 167
+
+ 
+ 
+ 167
+
+ 
+ 
+ 
+ 
+ Special Inspector General for Troubled Asset Relief Program
+
+ 
+ 
+ 34
+
+ 
+ 
+ 41
+
+ 
+ 
+ 41
+
+ 
+ 
+ 37
+
+ 
+ 
+ 41
+
+ 
+ 
+ 
+ 
+ Community Development Financial Institutions Fund 
+
+ 
+ 
+ 230.5
+
+ 
+ 
+ 233.5
+
+ 
+ 
+ 233.5
+
+ 
+ 
+ 221
+
+ 
+ 
+ 233.5
+
+ 
+ 
+ 
+ 
+ Financial Crimes Enforcement Network
+
+ 
+ 
+ 112
+
+ 
+ 
+ 113
+
+ 
+ 
+ 113
+
+ 
+ 
+ 113
+
+ 
+ 
+ 113
+
+ 
+ 
+ 
+ 
+ Bureau of the Fiscal Service a 
+
+ 
+ 
+ 348
+
+ 
+ 
+ 364
+
+ 
+ 
+ 360
+
+ 
+ 
+ 356
+
+ 
+ 
+ 364
+
+ 
+ 
+ 
+ 
+ Alcohol and Tobacco Tax and Trade Bureau
+
+ 
+ 
+ 100
+
+ 
+ 
+ 101
+
+ 
+ 
+ 105
+
+ 
+ 
+ 101
+
+ 
+ 
+ 106
+
+ 
+ 
+ 
+ 
+ Payment for Losses in Shipment
+
+ 
+ 
+ 2
+
+ 
+ 
+ 2
+
+ 
+ 
+ 2
+
+ 
+ 
+ 2
+
+ 
+ 
+ 2
+
+ 
+ 
+ 
+ 
+ Internal Revenue Service (total)
+
+ 
+ 
+ 10,945
+
+ 
+ 
+ 12,931
+
+ 
+ 
+ 10,107
+
+ 
+ 
+ 10,475
+
+ 
+ 
+ 11,235
+
+ 
+ 
+ 
+ 
+ Taxpayer Services 
+
+ 
+ 
+ 2,157 
+
+ 
+ 
+ 2, 401 
+
+ 
+ 
+ 2,232 
+
+ 
+ 
+ 2,247 
+
+ 
+ 
+ 2,156 
+
+ 
+ 
+ 
+ 
+ Enforcement b 
+
+ 
+ 
+ 4,860 
+
+ 
+ 
+ 5, 400 
+
+ 
+ 
+ 4,325 
+
+ 
+ 
+ 4,500 
+
+ 
+ 
+ 4,860 
+
+ 
+ 
+ 
+ 
+ Operations Support Activities c 
+
+ 
+ 
+ 3,638 
+
+ 
+ 
+ 4, 743 
+
+ 
+ 
+ 3,300 
+
+ 
+ 
+ 3,468 
+
+ 
+ 
+ 3,638 
+
+ 
+ 
+ 
+ 
+ Business Systems Modernization 
+
+ 
+ 
+ 290 
+
+ 
+ 
+ 3 79 
+
+ 
+ 
+ 250 
+
+ 
+ 
+ 260 
+
+ 
+ 
+ 290 
+
+ 
+ 
+ 
+ 
+ Rescissions: Treasury Forfeiture Fund
+
+ 
+ 
+ (-769)
+
+ 
+ 
+ (-875)
+
+ 
+ 
+ (-721)
+
+ 
+ 
+ (-700)
+
+ 
+ 
+ (-700)
+
+ 
+ 
+ 
+ 
+ Total 
+
+ 
+ 
+ $ 11,522 
+
+ 
+ 
+ $1 3,456 
+
+ 
+ 
+ $10,758 
+
+ 
+ 
+ $11,139 
+
+ 
+ 
+ $ 11,942 
+
+ 
+ 
+ 
+ 
+ Sources: H.Rept. 114-194 , S.Rept. 114-97 , and explanatory statement for House amendment #1 to the Senate amendment to H.R. 2029 .
+
+ Notes: Figures may not sum owing to rounding. 
+
+ a.
+
+ Starting in FY2104, the appropriation accounts for the Financial Management Service and the Bureau of Public Debt were combined into a single account called the Bureau of Fiscal Service. The main justification for the consolidation was to improve the efficacy and efficiency of Treasury's financial management operations. 
+
+ b.
+
+ The requested appropriation for enforcement in FY2016 included $352 million in additional funds as a program integrity cap adjustment for IRS enforcement initiatives to reduce future deficits. 
+
+ c.
+
+ The requested appropriation for operations support in FY2016 included $315 million in additional funds as a program integrity cap adjustment for IRS enforcement initiatives to reduce future deficits. 
+
+ 
+
+ 
+
+ FY2016 Treasury Appropriation Accounts: Current Status and Issues for Congress
+
+ This section examines the Obama Administration's FY2016 budget request for the Treasury Department and the enacted amount for the year. In addition, it discusses selected policy issues raised by the budget request or the provisions in those bills. These details are provided for each of the Treasury appropriation accounts (which number 9 or 10, depending on whether funding for the Office of Terrorism and Financial Intelligence (TFI) is counted as a separate account or folded into the DO account).
+
+ Departmental Offices
+
+ Budget Request
+
+ The President's FY2016 budget request for the Treasury Department included $332 million in appropriations for DO, or $9.3 million more than the amount enacted for FY2015. With the addition of reimbursable expenses from activities funded through the DO account, the DO operating budget would have totaled $453 million in FY2016.
+
+ Of the requested funding, $38 million would have gone to executive direction, $59 million to international affairs and economic policy, $76 million to domestic finance and tax policy, $110 million to terrorism and financial intelligence, and $50 million to Treasury management and related programs. 3 In addition, $25 million would have been available until the end of FY2017 for Treasury's Financial Statement Audit and Internal Control program and the modernization of Treasury's information technology systems; $9.5 million for the audit, oversight, and administration of the Gulf Coast Restoration Trust Fund ($7 million of that amount would come from the fund); $3 million for the development and implementation of programs in the Office of Critical Infrastructure Protection and Compliance Policy; and $10 million for a Digital Service team.
+
+ Relative to the enacted funding for FY2015, the budget request called for $20.6 million more for program expansions (including the Digital Service team), $5.2 million more to maintain FY2015 levels of operation, $3.2 million less in non-recurring expenses (including a reduction of $4.0 million in TFI costs), $0.4 million less from efficiency savings, $0.7 million in reinvestments, and $13.5 million less from adjustments (including $9.5 million less for the administration of the Gulf Coast Restoration Trust Fund).
+
+ H.R. 2995 
+
+ The House Appropriations Committee reported a bill ( H.R. 2995 ) on July 9, 2015, that would have provided $200 million in appropriations for DO in FY2016. This amount was not directly comparable with the budget request, as the request included funding for TFI. According to the report on the bill, the recommended appropriation was deemed sufficient to fully fund Treasury's cybersecurity initiatives and the administrative cost of implementing the Resources and Ecosystems Sustainability, Tourism Opportunities, and Revived Economy of the Gulf Coast Act ( P.L. 112-141 ). 4 
+
+ H.R. 2995 recommended that a separate appropriation account be established for TFI, and that it receive $116 million in FY2016, or $3.5 million more than the amount appropriated for FY2015. Combined with the recommended appropriations for DO, the bill would have provided a total of $316 million for activities labeled DO in the budget request, or $16 million less than the amount included in that request. 
+
+ The report also addressed several issues related to DO operations in FY2016. One was trafficking in wildlife and ivory poaching, mostly in Africa. The committee directed Treasury to submit reports six months apart in FY2016 to the House and Senate Appropriations Committees on the steps it was taking to implement the National Strategy on Wildlife Trafficking.
+
+ Another issue was an overdue report from Treasury on "economic warfare and financial terrorism." The committee pointed out that FY2015 marked the fifth year in a row when Treasury failed to submit such a document. The committee directed Treasury to submit the report in FY2016.
+
+ With regard to funding for TFI, the committee directed Treasury to identify online the companies that are not in compliance with the Iran Sanctions Act ( P.L. 104-172 ) and any foreign entities that are doing business with the Iran Revolutionary Guard Corps. Treasury also must submit two reports to both appropriations committees within 100 days of the enactment of the bill. One should address the Office of Foreign Assets Control's (OFAC's) policies and procedures for issuing general licenses; the other should provide certain details on OFAC's procedures for assisting innocent persons who cannot access their bank accounts or apply for credit because they have the same name as someone on the list of "designated and blocked" persons.
+
+ Another concern addressed by the committee was the operations of the Financial Stability Oversight Council (FSOC) and the Office of Financial Research (OFR). Both were created by the Dodd-Frank Wall Street Reform and Consumer Protection Act ( P.L. 111-203 ). Under current law, each office sets its own budget and then funds it by collecting fees from certain private institutions. As a result, Congress exercises no direct control over their operations through the appropriations process. To give Congress more influence, the committee included provisions in H.R. 2995 that would have required OFR and FSOC to submit quarterly reports on their "budget obligations" and would have subjected OFR to the annual appropriations process. Moreover, the committee urged the FSOC not to pursue what it called "failed or untested domestic policies through international agreements," but to consult with the Securities and Exchange Commission and take into consideration the distinctions among asset management organizations when deciding whether to designate a nonbank financial institution as a "systemically important financial institution," or SIFI. 
+
+ S. 1910 
+
+ S. 1910 , as reported by the Senate Appropriations Committee on July 30, would have given DO $326 million in appropriations in FY2016, or $116 million more than the amount enacted for FY2015 but $6 million less than the budget request. 5 The committee recommended that $112.5 million of that amount be reserved to fund the operations of TFI, or $2.5 million more than the budget request. A separate appropriations account for the Office would not have been created.
+
+ In its report on the bill, the committee addressed several issues. One was the financial literacy of American adults. According to recent data from Treasury's Office of Financial Education, one in seven adults is incapable of successfully completing financial tasks beyond those requiring the most "rudimentary" financial literacy skills. The committee recommended that OFE examine the extent to which individuals with rudimentary financial skills benefit from federal financial literacy programs and to develop "measurable" objectives for the improvement of those skills for the Financial Literacy and Education Commission.
+
+ The committee also directed TFI to "fully" implement all economic sanctions and divestment measures against the Islamic State of Iraq and the Levant, Russia, Belarus, North Korea, Iran, Sudan, Syria, Venezuela, Zimbabwe, and designated rebel forces operating in and around the Democratic Republic of the Congo. Treasury should notify the committee if its resources for enforcing those measures prove to be inadequate.
+
+ Issue for Congress
+
+ Proposed DO funding in FY2016 raised again the question of how TFI's budget should be managed. The Obama Administration and the Senate Appropriations Committee preferred that TFI appropriations remain an element of appropriations for DO. The House Appropriations Committee took the opposite view by carving out a separate appropriation account for TFI. At issue was the extent of congressional control over how much money is available for TFI's operations and how those funds are used.
+
+ Consolidated Appropriations Act, 2016 ( P.L. 114-113 ) 
+
+ The act gave DO $222.5 million in appropriations for FY2016. This amount did not include funding for TFI. Of that amount, $22.2 million would be available until September 20, 2017, for the following purposes: (1) the Treasury-wide Financial Statement Audit, (2) the modernization of DO's information technology, (3) the audit and management of the Gulf Coast Restoration Trust Fund, and (4) the development and implementation of new programs in the Office of Critical Infrastructure Protection and Compliance Policy.
+
+ According to the congressional explanatory statement for the act, Treasury's departmental offices may offer limited technical assistance to Puerto Rico. Treasury also must submit to the two appropriations committees a report in FY2016 on current and planned cloud computing usage by bureaus and offices.
+
+ Under the act, TFI separately received $117 million in appropriations for FY2016. Of that amount, no more than $27.1 million may be used for administrative costs, and $5 million will be available until the end of FY2017. In addition, the act stated that Congress expected TFI to "fully" implement sanctions and divestment measures against a number of designated countries (e.g., Sudan, Iran, Russia, and North Korea), and to notify Congress when TFI lacked the resources to do so. 
+
+ Departmentwide Systems and Capital Investments
+
+ Budget Request
+
+ The FY2016 Treasury budget request called for $10.7 million in appropriations for DSCIP, or about $8 million more than the amount enacted in FY2015. 6 There were no appropriations for the account in FY2012 and FY2013. 
+
+ The requested amount was to be used for two purposes. One was to construct a shared information technology infrastructure housed in existing Treasury buildings that would allow the analysis of large volumes of financial and managerial data related to various critical functions, such as TFI's operations. The second purpose was to repair the paver stones for the Treasury South Plaza to make it safer for pedestrians.
+
+ H.R. 2995 
+
+ H.R. 2995 , as reported by the House Appropriations Committee, recommended no funding for DSCIP in FY2016.
+
+ S. 1910 
+
+ The bill, as reported by the Senate Appropriations Committee, recommended that DSCIP receive $5 million in appropriations in FY2016, or $2.3 million more than the amount enacted for FY2015 but $5.7 million less than the budget request. The report on S. 1910 provided no details on how the funds should be used. But it did include a provision directing Treasury to submit an annual "Capital Investment Plan" to the House and Senate Appropriations Committees within 30 days after the release of the annual budget request.
+
+ Consolidated Appropriations Act, 2016
+
+ The act provided $5 million in appropriations for DSCIP in FY2016.
+
+ Office of Inspector General
+
+ Budget Request
+
+ The Treasury Department requested $35.4 million in appropriated funds for OIG in FY2016, or $65,000 more than the amount enacted for FY2015. 7 With the addition of an estimated $13.0 million in payments for services rendered by OIG, its operating budget for FY2016 could total $48.4 million. Of the requested funding, $28.3 million would be used for audits, and the remaining $7.1 million for investigations. Furthermore, $2.8 million of the requested amount would be available through the end of FY2017 for audits and investigations performed under Section 1608 of the Resources and Ecosystems Sustainability, Tourist Opportunities and Revived Economies of the Gulf Coast States Act of 2012 ( P.L. 112-141 , the RESTORE Act ).
+
+ The audits and investigations would satisfy the requirements of the Inspector General Act, as well as those of a number of statutes. Foremost among those laws are the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act, P.L. 111-203 ), the Federal Information Security Management Act ( P.L. 107-347 ), the Federal Deposit Insurance Act of 1950 (P.L. 81-797), the Improper Payments Elimination and Recovery Act ( P.L. 111-204 ), the Small Business Jobs Act of 2010 ( P.L. 111-240 ), the Digital Accountability and Transparency Act of 2014 ( P.L. 113-101 ), and the RESTORE Act. The Office of Audits expected to complete 77 audits in FY2016, which would be two more than the number it expected to complete in FY2015.
+
+ H.R. 2995 
+
+ The bill reported by the House Appropriations Committee recommended that OIG receive $35.4 million in appropriations in FY2016, or $65,000 more than the amount enacted for FY2015 and the same as the budget request. In its report on the bill, the committee stated that the recommended funding should cover all Treasury activities related to the RESTORE Act. 8 
+
+ S. 1910 
+
+ The bill reported by the Senate Appropriations Committee also recommended $35.4 million in appropriations for OIG in FY2016.
+
+ In its report on the bill, the committee "encouraged" the Office to investigate the security of Treasury's facilities and its information networks and systems. 9 
+
+ Another priority for the committee was an audit of the CDFIF's administration of the grants it distributed. More specifically, the committee wanted more details on the extent to which applications were approved according to current laws and regulations, whether the fund had adequate internal financial controls, whether it oversaw the grants it awarded, and whether there were methods in place to evaluate the extent to which outcomes matched program goals.
+
+ In addition, the committee directed OIG to submit a report to the two appropriations committees within 120 days of the bill's enactment on the treatment of BFS employees who were employed at the Fiscal Management Service before it merged with the Bureau of Public Debt. Of particular concern to the committee was the extent to which any such employees had been subjected to intimidation, demotion, or other actions that would encourage them to quit their jobs.
+
+ Consolidated Appropriations Act, 2016
+
+ The act provided $35.4 million in appropriations for OIG in FY2016.
+
+ Office of the Special Inspector General for the Troubled Asset Relief Program
+
+ Budget Request
+
+ Under the budget request, SIGTARP would have received $40.7 million in appropriations for FY2016, or $6.4 million more than the amount enacted for FY2015. 10 Taking into account unobligated balances from the previous year and funds from the Public-Private Investment Program administered by the Treasury Department, SIGTARP's operating budget in FY2016 could total $48.1 million. Relative to FY2015, the budget request called for an additional $0.8 million to maintain FY2015 operating levels and $5.7 million to replace the expected end of "no-year" (or mandatory) funding sometime during FY2016. Congress established this funding when it created SIGTARP under the Emergency Economic Stabilization Act of 2008 (EESA, P.L. 110-343 ) to supplement appropriations. 
+
+ The requested funding would have been used to uncover and investigate crimes related to the Troubled Asset Relief Program, which was also a product of the EESA. In addition, the funds would have supported the prosecution of individuals investigated by SIGTARP and continued the oversight of the financial institutions remaining in TARP and TARP-funded housing programs, which might last until 2023. In FY2016, the budget request would have allocated $31.8 million in appropriations to investigations and $8.9 million to audits; an estimated 78% of its entire budget would have gone to law-enforcement activities.
+
+ In explaining SIGTARP's budget request, the Treasury Department argued that the Office's budget should not necessarily depend on Treasury's involvement in TARP. This was because Congress created SIGTARP with the intention of keeping it in operation as long as TARP funds or commitments are outstanding. Thus, in Treasury's view, SIGTARP's funding did not hinge on Treasury's participation in the program but rather should reflect the Office's staffing requirements to handle its increasing amount of investigative work. 11 
+
+ H.R. 2995 
+
+ The bill, as reported by the House Appropriations Committee, recommended that SIGTARP receive $40.7 million in appropriations in FY2016, or $6.4 million more than the amount enacted for FY2015 and the same amount as the budget request. 12 
+
+ In its report on the bill, the committee acknowledged that the initial operating expenses of SIGTARP were funded through no-year appropriations, but that the amount of such funds had decreased over time and could be used up in FY2016. The committee also noted that to maintain SIGTARP's oversight of the remaining TARP funds, discretionary appropriations were essential. Still, as TARP winds down in coming years, the committee said that it expected requested appropriations for the account to also decline.
+
+ S. 1910 
+
+ The bill, as reported by the Senate Appropriations Committee, would have provided $36.7 million in appropriations for SIGTARP in FY2016, or $2.4 million more than the amount enacted for FY2015 but $4 million less than the budget request. 13 In its report on the bill, the committee noted that the Office could draw upon balances carried over from previous years to fund some of its investigations and audits and other needs in FY2016, obviating the need for a larger increase in discretionary appropriations. 
+
+ Consolidated Appropriations Act, 2016
+
+ The act provided $40.7 million in appropriations for SIGTARP in FY2016. According to the explanatory statement for the act, the office should focus its FY2016 audits and investigations on TARP housing programs and TARP financial institutions in an effort to prevent waste, fraud, and abuse in the use of TARP funds.
+
+ Treasury Inspector General for Tax Administration
+
+ Under the Treasury Department's budget request for FY2016, TIGTA would have gotten $167.3 million in appropriations or $9.1 million more than the amount enacted for FY2015. 14 Of this amount, $1.8 million would have been used for training. The requested increase in funding was based on $2.6 million to maintain FY2015 operating levels, $0.1 million in cost savings from efficiency improvements, and $6.6 million in program increases to allow TIGTA to develop "innovative tools and approaches" to help it detect and prevent fraudulent tax refunds stemming from identity theft and enhance its capability to protect the security of federal tax data from cyber-criminals.
+
+ TIGTA's operating budget for FY2016 would have exceeded the requested appropriations by an estimated $1.5 million (for a total budget of $168.8 million) because of reimbursements it receives for services rendered.
+
+ This budget finances TIGTA's audits, investigations, and evaluations of IRS operations. In FY2016, according to the budget proposal, the Office of Audit would have received $65.1 million in appropriations and $600,000 in reimbursements, while the Office of Investigations would have received $102.2 million in appropriations and $900,000 in reimbursements.
+
+ The Treasury Department pointed to the return on investment generated from TIGTA's investigations and audits as a key justification for increasing the office's budget. In FY2014, TIGTA generated a return on investment of $106 for each dollar spent on its operations. This return reflected both cost savings from IRS's operations and additional revenue from the collection of taxes. 15 
+
+ Among the top stated priorities for TIGTA in FY2016 were
+ identifying opportunities to achieve cost savings and other efficiencies in IRS's programs;
+
+ mitigating security risks to IRS employees and facilities;
+
+ improving the effectiveness of IRS's efforts to combat taxpayer identity theft and reduce improper claims and payments;
+
+ monitoring IRS's oversight of tax-exempt entities;
+
+ detecting waste, fraud, and abuse in IRS operations and criminal misconduct by IRS employees; and
+
+ overseeing IRS's implementation of the Affordable Care Act (ACA, P.L. 111-148 ) and the Foreign Account Tax Compliance Act (FATCA, P.L. 111-147 ).
+ H.R. 2995 
+
+ The bill, as reported by the House Appropriations Committee, would have given TIGTA $167.3 million in appropriated funds for FY2016, or $9.1 million more than the amount enacted for FY2015 and the same as the budget request. 16 In its report on the bill, the committee expressed its appreciation for the "many issues" that TIGTA had brought to the committee's attention in the past year.
+
+ The committee directed TIGTA to submit a report on IRS's readiness to manage and withstand cyberattacks to the two appropriations committees within six months of the enactment of H.R. 2995 . The report should evaluate the consequences of recent attempted and successful cyberattacks against the IRS, the steps taken (or being taken) by the IRS to prevent future attacks and to mitigate their effects, the IRS's cybersecurity policies and procedures, and the efforts by the agency to inform employees and contractors about the risks of cyberattacks.
+
+ S. 1910 
+
+ A bill reported by the Senate Appropriations Committee would also have provided TIGTA with $167.3 million in appropriations for FY2016. 17 In its report on S. 1910 , the committee acknowledged the added demand that increases in the size and responsibilities of the IRS place on TIGTA's resources.
+
+ The committee noted that since 2011, TIGTA has designated the security of taxpayer information as the top concern facing the IRS. To get a better understanding of current threats from cyber-criminals and what the IRS was doing to thwart or prevent them, the committee directed TIGTA to submit a report on cybersecurity within six months of the enactment of the bill similar in focus to the report mandated by the House Appropriations Committee.
+
+ In addition, the committee urged TIGTA to continue to monitor and report on IRS's actions on three different issues. One was the IRS's ability to detect and prevent taxpayer identity theft and related refund fraud, and the steps the IRS is taking to assist victims of such fraud. A second issue was the criteria used by the IRS to evaluate claims for tax-exempt status by social welfare organizations under Section 501(c) (4) of the federal tax code. Finally, the committee encouraged TIGTA to continue to monitor IRS's performance in implementing the ACA, especially the agency's ability to protect the confidentiality of taxpayer information shared with federal and state insurance exchanges, and to prevent ACA refund fraud.
+
+ Consolidated Appropriations Act, 2016
+
+ The act gave TIGTA $167.3 million in appropriations for FY2016.
+
+ Community Development Financial Institutions Fund 18 
+
+ The Treasury Department requested an appropriation of $233.5 million for CDFIF in FY2016, or $3.0 million more than the amount enacted for FY2015. 19 With the addition of expected reimbursements, user fees, and unobligated balances and recoveries from previous years, the budget request would have given CDFIF an operating budget of $245.2 million in FY2016, or $1.6 million less than the total for FY2015. Of the requested funding, $157.6 million was designated for the CDFI Program, $16.0 million for the Native American CDFI Assistance Program (NACA), $35.0 million for the Healthy Food Financing Initiative (HFFI), and $24.9 million for administrative expenses.
+
+ Relative to the amounts enacted for FY2015, the budget request allocated $0.4 million to maintain FY2015 operating levels and $21.2 million for program increases. These increases would have been distributed as follows: $5.2 million for the CDFI Program, $1 million for NACA, $13 million for HFFI, and $2 million for the Capital Magnet Fund (CMF). The budget request also included some funding decreases relative to FY2015: $0.1 million less for travel expenses; no funding for the Bank Enterprise Award Program (BEA), resulting in a savings of $18 million; and $0.5 million less for data collection (a non-recurring cost).
+
+ Since the creation of the CDFIF in 1994, it has awarded over $2.0 billion in grants and loans to CDFIs, community development organizations, insured depository institutions, NACA, and BEA. During the same period, the fund also awarded $80 in grants under the CMF and $9 million in grants through the Financial Education and Counseling Program. 20 
+
+ Although no direct appropriations are used for this purpose, the CDFIF has administered the New Markets Tax Credit (NMTC), which was available from 2000 to 2013. Taxpayers who made qualified equity investments were able to claim a credit equal to 39% of their investment, distributed equally over a period of seven years. Congress authorized a total of $40 billion in NMTCs to be awarded through 2013. The credit was awarded to investors through a competitive selection process. There were annual limits on the amount of qualified investment eligible for the credit: from 2010 to 2013, the annual limit was $3.5 billion. The budget request would have permanently extended the credit and allowed up to $5 billion in qualifying investments each year.
+
+ The Small Business Jobs Act of 2010 established the CDFI Bond Guarantee Fund (BGF). Bonds issued under the program support CDFI lending in poor, underserved communities by providing a source of long-term capital. Bonds issued by CDFIs or their designees are guaranteed by the Treasury Department, and the proceeds are lent to eligible CDFIs for community development purposes. The maturity of the bonds cannot exceed 30 years. In FY2013 and FY2014, the Treasury Department issued eight guarantees for bonds with a total face value of $525 million. In FY2015, it had the authority to issue up to $750 million in guarantees. The budget request would have extended the CDFI Bond Guarantee Program through FY2017 and increased the limit for newly issued loan guarantees to $1 billion in FY2016. 21 
+
+ H.R. 2995 
+
+ As reported by the House Appropriations Committee, the bill would have provided $233.5 million in appropriations for the CDFIF in FY2016, or $3.0 million more than the amount enacted for FY2015 and the same as the budget request. 22 Of the recommended funding, $176.4 million would have gone to technical and financial assistance grants for CDFIs, $16.0 million for NACA, $18.0 million for BEA, and $23.1 million for administrative expenses. There was no separate funding for HFFI or CMF.
+
+ In its report on the bill, the committee urged the CDFIF to use its Capacity Building Initiative to establish CDFIs in America Samoa, the Northern Mariana Islands, and other "U.S. insular areas."
+
+ S. 1910 
+
+ The bill, as reported by the Senate Finance Committee, would have provided $221.0 million in appropriations for CDFIF in FY2016, or $9.5 million less than the amount enacted for FY2015 and $12.5 million less than the budget request. 23 Of the recommended funding, $161.9 million was designated for technical and financial assistance grants to CDFIs, $15.0 million for NACA, $21.0 million for BEA, and $23.1 million for administrative expenses. Funding for the HFFI would come from the appropriations for financial and technical assistance grants for CDFIs.
+
+ S. 1910 would also allow the CDFIF to guarantee up to $750 million in bonds under the BGF in FY2016.
+
+ In its report on S. 1910 , the committee expressed concern about the fund's "nominal ability to verify investment impacts" and a "lack of transparency into many of the CDFI Fund's programs." The committee also asked for more details on how and to what extent "program funding generates meaningful community impacts." It directed CDFIF to establish clear reporting requirements for CDFIs and other awardees, and to collect and analyze "performance data." In addition, the committee urged the CDFIF to improve the quality and completeness of the data it tracks. Among the recommended steps the fund might take to achieve this goal were validating the accuracy of data reported by CDFIs and awardees, developing common definitions of key performance indicators, accounting for investment activity "in a timely manner" after an award has been issued, and developing a risk rating system for certified CDFIs.
+
+ Another issue addressed in the report was the flow of CDFI investments and loans to underserved and low-income non-metropolitan areas. The committee directed the fund to take into consideration the "unique conditions, challenges, and scale" of such areas when designing programs to promote economic revitalization and community development.
+
+ Issue for Congress
+
+ The three proposals for funding the CDFIF in FY2016 raised the question of the future status of two current programs: the Healthy Food Financing Initiative and the Bank Enterprise Award Program. On the one hand, the Obama Administration asked Congress to increase funding for the former from $22 million in FY2015 to $35 million in FY2016, but to provide no funds for the latter. No explanation for the proposed elimination of BEA funding was given in the budget documents. On the other hand, neither S. 1910 nor H.R. 2995 recommended separate funding for the HFFI in FY2016, but both would have funded the BEA. Under each bill, any funding for the HFFI presumably would have had to come out of the amount appropriated for financial and technical assistance grants for CDFIs. It may be the case that, though both Congress and the Administration supported the aims of both programs, they disagreed on the proper way to fund them and how much to allocate to each of them.
+
+ Consolidated Appropriations Act, 2016
+
+ The act gave CDFIF $233.5 million in appropriations for FY2016. Of that amount, $153.4 was designated for technical and financial assistance grants for CDFIs; $15.5 million for technical assistance and other purposes for native American, Alaskan, and Hawaiian communities; $22.0 million for the HFFI; $19.0 million for the BEA; and $23.6 million for administrative expenses. In addition, the act limited the total amount of loans that could be guaranteed under the BGF to $750.0 million in FY2016.
+
+ According to the explanatory statement for the act, Congress directed the fund to improve the quality and scope of the data it collects about its programs in order to make their results more transparent and easier to analyze. Congress also ordered the Treasury Department to consider the "unique conditions, challenges, and scale" of rural non-metropolitan areas when designing and administering programs intended to revitalize their economies and promote community development.
+
+ Financial Crimes Enforcement Network
+
+ Under the Treasury Department's budget request, FinCEN would have received $113.0 million in appropriations in FY2016, or $1.0 million more than the amount enacted for FY2015. 24 With the addition of an estimated $53.5 million in reimbursements, recoveries, and unobligated balances from previous years, FinCEN's operating budget in FY2016 would have totaled an estimated $166.5 million. Relative to FY2015, the budget request included an added $1.9 million to maintain FY2015 levels of operation and reductions of $0.7 million for efficiency savings and $0.2 million for a loss of two full-time administrative positions. 
+
+ FinCEN's priorities in FY2016 are
+ adopting "strong" safeguards against money laundering and terrorist financing; 
+
+ implementing and enforcing those safeguards and using targeted financial measures against specific threats;
+
+ using research, analysis, and advanced "analytics" to detect and explain threats to the U.S. financial system; 
+
+ implementing and managing programs to coordinate and share financial intelligence between FinCEN and its foreign and domestic partners in government and private industry; and 
+
+ developing and maintaining technologies for collecting and assessing financial intelligence from the private sector and sharing it with foreign and domestic agencies.
+ H.R. 2995 
+
+ The bill, as reported by the House Appropriations Committee, recommended that FinCEN receive $113.0 million in appropriations for FY2016, or $1 million more than the amount enacted for FY2015 and the same as the budget request. 
+
+ In its report on H.R. 2995 , the committee urged FinCEN to use its expertise in analyzing financial flows and transactions to assist investigations by domestic law enforcement agencies into human trafficking. 25 
+
+ S. 1910 
+
+ Under the bill, as reported by the Senate Appropriations Committee, FinCEN would have received $113.0 million in appropriations in FY2016, or $1 million more than the amount enacted for FY2015 and the same as the budget request. 26 
+
+ In its report on the bill, the committee encouraged FinCEN to alert financial institutions subject to the reporting requirements of the Bank Secrecy Act about the growing risk of cybercriminals attempting to launder the proceeds from the theft of online data through the U.S. financial system. To lower the risk, the committee recommended that FinCEN provide these institutions with a list of indicators of cybercrime that they could refer to when filing suspicious activity reports (SARs) on the laundering of money tied to cybercrimes.
+
+ The committee also expressed appreciation for the contributions FinCEN had made in recent years to interagency efforts to combat human trafficking and slavery. It commended the advisory FinCEN sent to financial institutions in September 2014 alerting them to signs of money laundering related to human trafficking activities in filing SARs.
+
+ Consolidated Appropriations Act, 2016
+
+ The act gave FinCEN $113.0 million in appropriations for FY2016.
+
+ Alcohol and Tobacco Tax and Trade Bureau
+
+ The Treasury Department requested $101.4 million in appropriations for ATTB in FY2016, or $1.4 million more than the amount enacted for FY2015. 27 Taking into account anticipated reimbursements and a transfer of enforcement funds from the IRS through a program integrity cap adjustment, the operating budget for ATTB would have totaled $112.7 million in FY2016, or $5.7 million more than the operating budget for FY2015. 
+
+ Relative to the amount enacted for FY2015, the budget request called for an increase of $1.7 million to maintain FY2015 operating levels; a decrease of $1.2 million from a cutback in ATTB's Criminal Enforcement Program, closures of a number of field offices, the increased use of Open Source software, and lower administrative costs; and increases of $1.0 million to modernize the alcohol beverage labeling program to streamline and simplify the label application and approval process, and $5.0 million for the bureau's alcohol and tobacco enforcement and compliance program to bolster its efforts to reduce the federal tax gap. 28 
+
+ In FY2016, ATTB's priorities are to
+ collect $22 billion in excise tax revenues from the sale of tobacco and alcohol products;
+
+ finish audits and investigations of ATTB taxpayers, based on risk and on random selection, to ensure they operate lawfully and comply with tax laws;
+
+ detect and deter criminal diversion of revenues from the domestic production and sale of tobacco and alcohol products;
+
+ find regulatory solutions to problems related to tax rate differences among tobacco products; 
+
+ reduce the cost of compliance for ATTB taxpayers by improving and promoting electronic options for filing tax payments and applications for permits and labels;
+
+ conduct studies of current compliance with federal regulations for the production and sale of alcoholic beverages and use the findings to improve enforcement and compliance programs;
+
+ enhance ATTB product safety programs targeted at domestic and imported alcoholic beverages;
+
+ promote U.S. exports of tobacco and alcohol products by helping U.S. companies understand and comply with foreign rules and regulations and working with foreign governments to lower barriers to imports of U.S. products; and
+
+ work effectively with foreign governments to prevent the loss of tax revenue from illicit activities such as smuggling. 29 
+ H.R. 2995 
+
+ As reported by the House Appropriations Committee, the bill would have provided $105.0 million in appropriations for ATTB in FY2016, or $5 million more than the amount enacted for FY2015 and $3.6 million more than the budget request. 30 Of the recommended funding, $5 million would be designated for efforts to accelerate the processing of formula and label applications for alcohol products.
+
+ In its report on H.R. 2995 , the committee expressed concern over delays in the approval of these applications, which are required under the Federal Alcohol Administration Act of 1935 (P.L. 74-401, as amended). To address this concern, the committee directed ATTB to submit a report to both appropriations committees within 60 days of the enactment of the bill on how the office would use the additional $5 million to speed up the review of label and formula applications and to issue "clear and consistent" regulations.
+
+ ATTB is presently reviewing the laws that govern its activities and duties, especially Title 27, Chapter 1, Subchapter A, Parts 4, 5, and 7, which address the labeling and marketing of wine, beer, and distilled beverages. The committee endorsed the review, provided it was done expeditiously and led to "significant" improvements based on current markets and technologies for alcoholic beverages. 31 
+
+ S. 1910 
+
+ The bill, as reported by the Senate Finance Committee, recommended that ATTB receive $101.4 million in appropriations for FY2016, or $1.4 million more than the amount enacted for FY2015 and the same as the budget request. 32 
+
+ In its report on S. 1910 , the committee urged ATTB to strengthen the enforcement of the laws and regulations governing the production and sale of tobacco and alcohol products. Of particular concern to the committee were recent increases in excise tax evasion for these products.
+
+ In addition, the committee recommended that ATTB streamline its process for approving label applications through "strategic investments" in the resources and technologies needed to speed up the review of these applications.
+
+ Consolidated Appropriations Act, 2016
+
+ The act provided ATTB with $106.4 million in appropriations in FY2016. Of that amount, $5.0 million was set aside to cover costs related to accelerating the processing of applications for labels and formulas. 
+
+ Bureau of the Fiscal Service
+
+ Under the President's budget request, BFS would have received $363.8 million in appropriations in FY2016, or $15.7 million more than the amount enacted for FY2015. 33 Of this amount, $4.2 million was designated for initiatives to upgrade the bureau's information systems; the money would have been available through the end of FY2018. With the addition of $227.9 million in anticipated reimbursements, the BFS's operating budget would have totaled $591.7 million in FY2016. Relative to the FY2015 budget, the budget request called for an another $5.9 million to maintain FY2015 operating levels; decreases of $8.5 million for efficiency savings and $1.5 million for program cuts; and an additional $19.8 million (available until September 30, 2018) to support Treasury's responsibilities for implementing the Digital Accountability and Transparency Act (DATA Act, P.L. 113-101 ) and associated financial data standards.
+
+ The FY2016 budget request could also be broken down by major programs, of which there are nine: (1) collections, (2) debt collection, (3) Do Not Pay Business Center, (4) government agency investment services, (5) government-wide accounting and reporting, (6) payments, (7) retail securities service, (8) summary debt accounting, and (9) wholesale securities services. Collections would have received $26.6 million in appropriations; debt collection, no appropriations; Do Not Pay Business Center, $5.1 million; government agency investment services, $13.1 million; government-wide accounting and reporting, $68.5 million; payments, $133.2 million; retail securities services, $94.1 million; summary debt accounting, $4.2 million; and wholesale securities services, $18.9 million.
+
+ Several legislative proposals were included in the budget request. They would have authorized BFS to undertake the following actions: 34 
+ offset federal income tax refunds to collect delinquent state tax obligations, regardless of the state in which the debtor resides;
+
+ amend its regulations to allow states to send notices for state income tax obligations by first-class mail, rather than certified mail;
+
+ levy up to 100% of a payment to a Medicare provider to collect unpaid taxes;
+
+ issue garnishment orders for commercial accounts to financial institutions without a court order;
+
+ recover U.S. assets and keep a portion of the amounts collected to pay for the costs of recovery; and
+
+ use automated dialing systems and pre-recorded voice messages when contacting wireless phones to collect debts.
+ In FY2016, BFS plans to pursue the following objectives:
+ continue to implement the DATA Act;
+
+ improve the federal government's fiscal operations by helping agencies migrate to a shared-service model for their financial systems;
+
+ promote greater use of the U.S. Debit Card and Card Management Services and greater reliance on electronic submissions for non-tax debt collections and payments;
+
+ expand the use of the Do-Not-Pay Business Center by federal agencies to reduce improper payments;
+
+ continue to prepare for a "clean" audit of the Treasury Financial Report by FY2018 through providing technical support for federal agencies adopting the Central Accounting and Reporting System;
+
+ make it easier for federal agencies to submit claims electronically through improvements to the Post Payment System, the Stored Value Card program, and the Invoice Processing Platform;
+
+ encourage investors to make greater use of the my RA Program and increase their awareness of the new Treasury Retail Investment Management system; and
+
+ continue to deploy the latest strategies for increasing the collection of delinquent non-tax debt.
+ H.R. 2995 
+
+ As reported by the House Appropriations Committee, H.R. 2995 would have provided $360.0 million in appropriations for the BFS in FY2016, or $11.8 million more than the amount enacted for FY2015 but $3.8 million less than the budget request. 35 Of the recommended funding, $4.2 million would have been available until September 30, 2018, to modernize the bureau's information systems.
+
+ In its report on H.R. 2995 , the committee noted that the measure included funding for the USAspending.gov initiative, which should help BFS achieve its transparency goals.
+
+ The committee also directed the bureau to issue separate reports on payments made in FY2014 and in FY2015 from the Judgment Fund under 31 U.S.C 1304 within 60 days of the enactment of the bill. Each report should account for all payments made from the fund going back to 2008.
+
+ S. 1910 
+
+ As reported by the Senate Appropriations Committee, the bill would have provided $356.0 million in appropriations for BFS in FY2016, or $7.8 million more than the amount enacted for FY2015 but $7.8 million less than the budget request. 36 
+
+ In its report on S. 1910 , the committee stated that the bill contained funds for improving government-wide financial management through the USAspending.gov initiative.
+
+ The committee also directed BFS to submit a report to both appropriations committees within 180 days of the enactment of the bill on the status of the Do Not Pay Business Center. The report should address the following topics:
+ whether and how the center used payment and beneficiary enrollment data for state programs to identify improper federal payments,
+
+ the extent to which there was duplication in payments among federal programs,
+
+ other information that might be effective in preventing improper payments,
+
+ interagency tools and practices that could be useful in preventing waste and fraud in federal payments,
+
+ the methodology for determining to what extent investigations by the center have reduced improper payments, and
+
+ a schedule for achieving the goals of the center.
+ Furthermore, the committee expressed support for the steps taken by BFS to implement the provisions in the DATA Act intended to standardize and disclose the reporting of federal agency expenditures. It directed the bureau to keep the committee informed of new developments.
+
+ Consolidated Appropriations Act, 2016
+
+ The act gave BFS $363.8 million in appropriations for FY2016. Of that amount, $19.8 million may be used until September 30, 2018, for implementing the DATA Act. In addition, the act permitted BFS to withdraw up to $165,000 from the Oil Spill Liability Trust Fund to cover its costs for managing the fund. 
+
+ Treasury Forfeiture Fund (TFF)
+
+ The Treasury Department's budget request included a proposal to cancel permanently $875.0 million in unobligated balances from the TFF in FY2016. 37 This would come on top of a permanent $963.6 million reduction in those balances enacted for FY2015. 
+
+ The fund serves as the receipt account for the deposit of non-tax assets seized by participating federal bureaus: the IRS's Criminal Investigation unit, the U.S. Secret Service, the Bureau of Customs and Border Patrol, and the Bureau of Immigration and Customs Enforcement. The Treasury Executive Office for Asset Forfeiture (TEOAF) manages the fund. Money in the fund is used to pay for the operating expenses of TEOAF and to support the enforcement activities of the bureaus involved in the National Money Laundering Strategy, the Southwest Border Strategy, and government efforts to combat terrorist financing. 
+
+ TEOAF estimated that $413.0 million would likely be deposited in the fund from asset forfeitures in FY2016. After accounting for earned interest, the restoration of reductions from sequestration, temporary rescissions and recoveries from previous years, and the unobligated balance from the previous year, the amount of money in the fund could total an $1.6 billion in FY2016, or $36.3 million less than the estimated amount in FY2015. According to TEOAF, expenses and obligations for FY2016 may amount to $480.0 million. Combining that amount with the proposed permanent rescission of $875.0 million would mean that the unobligated balance in the fund at the end of FY2016 would be $204.8 million, or $52.6 million more than the estimated total at the end of FY2015.
+
+ H.R. 2995 
+
+ As reported by the House Appropriations Committee, the bill would have shrunk the unobligated balance in the fund by $721.0 million in FY2016, or $48.0 million less than the rescission enacted for FY2015 and $154.0 million less than the rescission requested by Treasury. 38 
+
+ In its report on H.R. 2995 , the committee stated that the resources in the fund should not be used to "augment agency funding" or to "circumvent the appropriations process."
+
+ In addition, the committee directed Treasury to submit to both appropriations committees each month in FY2016 a table showing the interest earned, forfeiture revenue collected, unobligated balances, recoveries and expenses to date. The table should also include an estimate of expenses for the remainder of the fiscal year.
+
+ S. 1910 
+
+ In the bill, the Senate Finance Committee recommended a rescission of $700.0 million from the fund in FY2016, or $69.0 million less than the rescission enacted for FY2015 and $175.0 million less than the budget request. 39 
+
+ Consolidated Appropriations Act, 2016
+
+ The act mandated a rescission of $700 million from the unobligated balances in the TFF in FY2016.
+
+ Internal Revenue Service
+
+ The Obama Administration asked for $12.931 billion in appropriations for the IRS in FY2016, or $1.986 billion more than the amount enacted for FY2015. 40 Of this amount, $2.409 billion would have gone to taxpayer services, $5.400 billion to enforcement (including a $352.1 million program integrity cap adjustment under Section 251(b)(2) of the Balanced Budget and Emergency Deficit Control Act of 1985 ( P.L. 99-177 , BBEDCA)), $4.743 billion to operations support (including a $315.2 million program integrity cap adjustment), and $379.2 million to the Business Systems Modernization (BSM) program. With the addition of funds from reimbursements, user fees, recoveries and unobligated balances from previous years, transfers in and out, resources from other accounts, and offsetting collections, the operating budget for the IRS in FY2016 could have totaled an estimated $13.922 billion, or $1.946 billion more than the estimated FY2015 budget.
+
+ Relative to IRS's FY2015 enacted appropriations, the budget request called for an additional $200.7 million to maintain FY2015 operating levels, a decrease of $18.4 million from efficiency savings, an increase of $16.0 million for expanding the agency's telecommunications network to handle increased customer demand, and $1.787 billion for program increases in taxpayer services, enforcement, and infrastructure development. Over 37% of the amount for program increases (or $667.3 million) would have come from integrity program cap increases. 
+
+ The budget request would have amended the BBEDCA to lift the discretionary budget caps for the IRS. Under the act, Congress created a mechanism for boosting spending allocations among programs that generate a positive return on investment. Increases in those allocations are known as program integrity cap adjustments. Under the FY2016 budget request, the adjustments would have given the IRS an additional $352.1 million for tax enforcement and an added $315.2 million for operations support. As noted earlier, $5 million of the cap adjustment for enforcement would be transferred to TTB to pay for new enforcement initiatives in FY2016. 
+
+ According to the IRS's budget request for FY2016 was intended to address the following priorities:
+ Taxpayer Service 
+
+ Improving the level of taxpayer assistance through the IRS's toll-free telephone service
+
+ Meeting increased demand from taxpayers for help in complying with ACA requirements
+
+ Delivering enhanced online service options to taxpayers
+
+ Providing greater assistance to low-income taxpayers and those in need of tax relief because of financial hardship
+
+ Enforcement 
+
+ Improving tax compliance by implementing FATCA, ACA, and the Information Return Document Matching program for merchant payment cards, third-party reimbursements, and basis reporting for stock transactions
+
+ Reducing the revenue loss from tax return fraud, including fraud from identity theft
+
+ Reversing recent declines in examination and collection efforts 
+
+ Increasing the number of criminal investigations
+
+ Rebuilding public trust in IRS's enforcement of compliance in the tax-exempt sector
+
+ Infrastructure 
+
+ Maintaining critical IT infrastructure
+
+ Upgrading IRS facilities to address health and safety concerns
+
+ Upholding the integrity of "revenue financial systems"
+
+ Business Systems Modernization 
+
+ Developing new IT capabilities such as increasing self-service options at IRS.gov, including
+
+ the Get Transcript tool which gives taxpayers direct online access to their tax accounts
+
+ IRS Direct Pay, which offers a free, secure online option for scheduling and making tax payments
+
+ IRS2Go, which allows taxpayers to find out the status of their refund through the IRS website
+
+ Developing a shared platform for case management
+ Reducing the federal tax gap is an ongoing priority for the IRS. The gap is defined as the difference between the amount of federal income, excise, estate, and employment taxes owed in a year and the amount of those taxes paid in full on time. According to the latest estimate by the IRS, the gross gap totaled $450 billion in 2006; after allowing for late payments and the revenue collected through IRS enforcement activities, the net gap for 2006 was an estimated $385 billion. 41 The gap has three components: underreporting of income, failure to file, and underpayment of the taxes owed. Underreporting accounted for 84% of the 2006 gross gap, underpayment for 10%, and non-filing for 6%.
+
+ One justification for the budget request that Treasury emphasized in its budget documents was the likely revenue gains from FY2016 enforcement initiatives. Enforcement initiatives raise revenue by deterring taxpayers from failing to meet their tax obligations and by collecting overdue taxes. In FY2014, the most recent year for which figures are available, IRS enforcement actions resulted in $57 billion in tax collections, the fifth straight year when more than $50 billion was collected in this manner. Treasury has long pointed out that activities such as examination and collection yield substantial returns on investment, and that Congress should take those returns into consideration when deciding how much money to appropriate for the IRS in a fiscal year. According to an IRS estimate, its proposed FY2016 revenue-producing initiatives not funded through a program integrity cap adjustment would have yielded a return on investment of $4.1 for each dollar spent on those initiatives by FY2018, when they would be fully phased-in. What is more, the return on investment would rise to $6.4 by FY2018 for each dollar spent on initiatives funded through the cap adjustment. 42 
+
+ H.R. 2995 
+
+ As reported by the House Appropriations Committee, the bill would have provided $10.107 billion in appropriations for the IRS in FY2016, or $838.4 million less than the amount enacted for FY2015 and $2.824 billion below the budget request. 43 If enacted, the bill would have given the IRS less in appropriations than it received in FY2004. It would also have imposed the following limits on the IRS's use of appropriated funds in FY2016:
+ No funds could be used to grant employee bonuses and awards that fail to consider the conduct and tax compliance record of the recipients.
+
+ No funds could be used to hire former employees without considering their past conduct while at the IRS and their compliance with tax laws.
+
+ No funds could be used to give additional scrutiny to groups applying for tax-exempt status because of their religious beliefs.
+
+ No funds could be used to target individuals for extra scrutiny for "exercising their First Amendment rights."
+
+ No funds could be used for conferences that do not conform to TIGTA's recommendations for such events.
+
+ No funds could be used to produce videos that had not been reviewed for their cost, topics, tone, or purpose and had been certified to be "appropriate."
+
+ No funds could be used to implement new regulations regarding the criteria used to determine whether organizations qualify for tax-exempt status under Section 501(c)(4) of the Internal Revenue Code.
+
+ No funds could be transferred to the IRS from the Department of Health and Human Services to implement the ACA.
+
+ No funds could be used to implement the individual mandate under the ACA.
+
+ No funds could be used in ways that "violate the confidentiality of tax returns."
+
+ No funds could be used to design pre-populated individual tax returns.
+ Taxpayer Ser vices 
+
+ H.R. 2995 would have provided $2.232 billion for taxpayer services in FY2016, or $75.0 million more than the amount enacted for FY2015 but $177.2 million less than the budget request. 44 In its report on the bill, the committee noted that the increase from FY2015 was intended to improve IRS's level of service to taxpayers. The committee also stated that the Taxpayer Advocate Service should be "sufficiently" funded from the funds appropriated for taxpayer services. 
+
+ The report also addressed the committee's concerns about recent increases in instances of tax fraud related to identity theft. In the committee's view, this problem has become "especially pernicious" in U.S. territories and possessions. To monitor the results of IRS's efforts to combat identity theft and refund fraud, the committee directed the agency to submit a report to the two appropriations committees by June 17, 2016. The report should cover the period from 2009 to 2015 and provide the following details: (1) the number of taxpayers who had their tax return rejected because their Social Security or taxpayer identification numbers were stolen by someone to commit tax fraud; (2) the average time required to resolve the problem and send a refund to taxpayers who were due one; (3) the number of cases involving stolen taxpayer identification numbers of residents of U.S. territories and possessions; and (4) the effectiveness of steps taken by the IRS to expedite the resolution of identity theft cases, to prevent others from becoming victims, and to educate the public on the risk of identity theft.
+
+ Another concern addressed in the report was the persistence of fraudulent and erroneous claims for the Earned Income Tax Credit (EITC). 45 To lower the incidence of such claims, the committee recommended that the IRS convene a summit meeting in 2016 of tax-preparation firms, payroll and tax refund processors, and state tax commissioners to agree on new, more effective strategies for verifying that someone is eligible to claim the credit without deterring eligible individuals from filing such a claim.
+
+ The committee also expressed its opposition to pre-filled or so-called simple tax returns. In its view, such a filing system would "change the relationship between taxpayers and their government," strain IRS resources, impose new burdens on employers (especially small companies), and create a conflict of interest by forcing the IRS to act simultaneously as a tax collector and enforcer of tax compliance on the one hand, and as a financial advisor and tax preparer on the other hand. As a result, the committee added language to the report that would have prohibited the agency from working on a pilot project involving a simple tax return without first getting both the approval of the two appropriations committees and appropriations for that purpose.
+
+ Enforcement 
+
+ H.R. 2995 , as reported by the House Committee on Appropriations, would have provided the IRS with $4.325 billion in appropriations for tax law enforcement in FY2016, or $535.0 million less than the amount enacted for FY2015 and $1.075 billion less than the budget request. Of the recommended funding, $57.5 million would be reserved to support IRS's involvement with the Interagency Crime and Drug Enforcement program. None of the enforcement funds could be used to implement the ACA.
+
+ In its report on the bill, the committee addressed several issues. One was the regulation of paid tax preparers. In June 2014, in response to a federal court ruling that the IRS lacked the authority to regulate professional tax preparers, the agency initiated a voluntary regulatory program with many of the same requirements as the mandatory program that was rejected by the courts. To assess the cost-effectiveness of the voluntary program, the committee directed the IRS to submit a report, after it had been reviewed by the Government Accountability Office (GAO), to both appropriations committees within 120 days of the enactment of the bill. The report should evaluate the accuracy of returns prepared by participants in the voluntary program and the amount of improper IRS payments resulting from those returns. The report should also compare the costs of voluntary and mandatory regulatory programs and evaluate the likely impact on accuracy of a mandatory program. 
+
+ Another issue was the timing of information returns. To decrease the number of improper refunds, the Treasury Department had proposed setting the filing deadline for information returns earlier in the filing season. To assess the feasibility of such a proposal, the committee ordered the IRS to submit a report, after it had been reviewed by the GAO, to both appropriations committees not later than 120 days after the enactment of H.R. 2995 on the cost to the federal government and the private sector of setting an earlier filing deadline for information returns. The report should examine the time it would take the government and private entities to implement such a change and its impact on the accuracy of information returns in general.
+
+ In addition, the committee urged the IRS to work with the Department of Justice and the Federal Trade Commission to devise a common approach to reducing and preventing tax fraud from identity theft. Such an approach should take into account the needs and concerns of vulnerable groups of taxpayers, such as senior citizens. In the committee's view, the IRS should try to notify taxpayers in a timely manner when they are "potential victims of identity theft."
+
+ Compliance with the requirements for the EITC also drew comments from the committee. It attributed improper payments of the credit, in part, to the complexity of the credit itself. To address this issue, the committee directed the Treasury Office of Tax Policy and the IRS Office of Research, Analysis, and Statistics to undertake a "data-driven" study, in collaboration with paid tax preparers, of ways to improve EITC compliance. 
+
+ Another issue addressed by the committee was the ongoing controversy over IRS's management of the process of reviewing applications for tax-exempt status by social welfare entities under Section 501(c)(4) of the federal tax code. H.R. 2995 would have barred the IRS from implementing in FY2016 any new regulations on the criteria used to determine an entity's eligibility for that status.
+
+ Operations Support 
+
+ In H.R. 2995 , the House Committee on Appropriations recommended that the IRS receive $3.300 billion for operations support, or $338.4 million less than the amount enacted for FY2016 and $1.443 billion below the budget request. None of the recommended funding could have been used to implement the ACA.
+
+ In its report on the bill, the committee encouraged the IRS to continue provide printed tax forms and instructions to "vulnerable populations." Among such groups were residents of rural areas where Internet usage rates are below the national average.
+
+ The committee also directed the IRS to prepare a report on the number of official hours employees spend on union activities and on the amount of related travel expenses and submit it to both appropriations committees within 90 days of the enactment of H.R. 2995 .
+
+ At the behest of the committee, the GAO was to assess the cost and production schedule for all major IRS IT projects during FY2016, especially the projects that the IRS covered in quarterly reports to the committees, and submit an annual report to both committees.
+
+ Another concern discussed in the report was IRS's pilot program for identity protection, which was intended to cut the incidence of refund fraud resulting from identity theft. The committee ordered the IRS to submit a report to both committees within 120 days of the enactment of the bill on the effectiveness of the program. The report should examine the following topics: (1) the cost of expanding the program to cover all taxpayers, (2) the reduction in tax fraud that might result from such an expansion, and (3) the cost of assisting taxpayers who were victims of identity theft.
+
+ Business Systems Modernization 
+
+ As reported by the House Committee on Appropriations, the bill would give the IRS $250 million for the BSM program, or $40 million less than the amount enacted for FY2015 and $129.2 million below the budget request.
+
+ In its report on H.R. 2995 , the committee pointed out that the major expenses for developing and implementing the program had already been incurred. Therefore, future funding requests, in the committee's view, should decline as the agency realized savings from retiring aging IT systems.
+
+ As it did with funding for operations support, the committee directed the GAO to submit an annual report to both committees on the cost and deployment schedule for all major IRS IT projects in FY2016.
+
+ S. 1910 
+
+ The bill, as reported by the Senate Finance Committee, would have provided $10.475 billion in appropriations for the IRS in FY2016, or $470.0 million less than the amount enacted for FY2015 and $2.456 billion less than the budget request. 46 
+
+ In explaining why it sought another cut in funding for the IRS, the committee argued that the IRS "continues to ignore the impact of its own behavior on the attitudes of taxpayers." As result, taxpayers have "lost faith in the institution, and it is incumbent upon the agency to regain" their trust. The committee cited three examples to support its case: (1) the IRS's "disparate treatment" of politically conservative and politically liberal entities seeking tax-exempt status under Section 501(c)(4); (2) the IRS's practice of hiring former employees with past performance problems; and (3) its "willingness to cut services to taxpayers in an effort to garner support for increased resources."
+
+ The committee expressed concern about the IRS's ability to allocate resources among its primary responsibilities during a period of "fiscal austerity and budgetary constraints." It noted that the IRS collected hundreds of millions of dollars in fees annually for the services it provided to taxpayers, and that the IRS had almost complete control over how those fees were used. According to an estimate by the IRS, the agency could receive an estimated $450.4 million in such fees to supplement its appropriated funds in FY2016. In the committee's view, the IRS's process for allocating resources lacked "transparency." As a result, the committee directed the agency to submit a spending plan for the user fees it received within 60 days of the enactment of S. 1910 ; the plan should provide details on how the IRS would allocate those fees among its four appropriations accounts to support specific programs, initiatives, and investments.
+
+ In addition, the committee recommended that no appropriated funds be used for awarding bonuses to employees or hiring former employees without first considering their job performance and tax compliance.
+
+ Taxpayer Services 
+
+ As reported by the committee, S. 1910 would provide $2.246 billion in appropriations for taxpayer services in FY2016, or $90 million more than the amount enacted for FY2015 but $163 million less than the budget request. Of the recommended funding, at least $5.6 million would go to the Tax Counseling for the Elderly program; $12.0 million to Low-Income Tax Clinic grants; $12.0 million to the Volunteer Income Tax Assistance matching grant program (to be made available over two fiscal years); and $206.0 million to the Taxpayer Advocate Service, of which $5.0 million would be set aside for assisting victims of identity theft and refund fraud.
+
+ In its report on the bill, the committee pointed out that the IRS had control over how it allocates the user fees it receives among its major functions and was allowed to transfer up to 5% of the funding enacted for FY2016 among those functions, with the consent of the House and Senate Appropriations Committees. In FY2015, the IRS allocated 75% less of its user fees to taxpayer services than it did in FY2014. The committee urged the IRS to devote a greater proportion of its user fees to taxpayer services in FY2016. Of the recommended appropriation for these services, $90 million was designated for "measureable" improvements in taxpayer services and faster resolution of identity theft cases.
+
+ The committee criticized the IRS for recent declines in the level of telephone service (LOS). According to a 2015 TIGTA report, the number of Automated Collection Service contact representatives decreased by 24% from FY2011 to FY2014, and this decline contributed to a 25% decrease in the number of taxpayer phone calls answered in that period. 47 The average wait time for a caller increased nearly 97% from the 2011 filing season to the 2014 filing season, when it reached 15.9 minutes. 48 In the committee's view, the IRS had the authority to offset any reductions in taxpayer service appropriations with user fees. The committee urged the agency to assign a high priority to improving its LOS in FY2016. 
+
+ The committee also expressed concern about the possible closure of taxpayer assistance centers (TACs) in FY2016. When the report on S. 1910 was issued, the IRS was in the midst of a six-year effort to evaluate taxpayer preferences in dealing with the IRS. The main goals of the effort were to improve taxpayer services and to provide taxpayers with more secure self-service options through the IRS's website. At the behest of the committee, before the IRS closed another TAC, it had to submit a report to the committee describing the characteristics of the taxpayers that had used the centers in the past decade, including their computer and language proficiencies, and explaining how the IRS planned to meet the needs of those taxpayers. The report should discuss the criteria used by the IRS to select TACs for closure and the likely impact of planned closures on the tax compliance of the affected taxpayers. The committee also directed the IRS to take the following steps before closing a center: (1) notify the public about the geographic area served by the center; (2) hold at least one public hearing on the possible effects of the closure on taxpayer compliance; and ( 3) report to the committee on the concerns expressed by the taxpayers served by the center.
+
+ Another issue addressed by the committee in its report on S. 1910 was the availability of adequate service for taxpayers residing in rural areas and in Alaska and Hawaii. In the case of rural areas, it directed the IRS to report to the committee within 120 days of the enactment of the bill on the measures it was taking to "alleviate" the problems faced by rural taxpayers in getting the needed guidance to file their returns. In the case of Alaska and Hawaii, the committee directed the IRS to ensure that each Taxpayer Advocate Service Center in the two states was staffed with a Collection Technical Advisor and an Examination Technical Advisor, in addition to other staff.
+
+ Enforcement 
+
+ S. 1910 recommended that the IRS receive $4.500 billion in appropriations for enforcement activities in FY2016, or $360 million less than the amount enacted for FY2015 and $900 million less than the budget request. 
+
+ One issue the committee addressed in its report on the bill was identity theft and related refund fraud. It expressed concern about the IRS's performance in reducing the level of such fraud and the time it took to resolve cases involving taxpayers who were victims of identity theft and refund fraud. In a bid to improve that performance, the committee directed the agency to report to the two appropriations committees within 90 days of the enactment of the bill on its plans for implementing a more effective approach to authenticating the identity of a taxpayer, and for cutting in half the average time a taxpayer must wait to resolve a case involving refund fraud.
+
+ The committee also discussed the question of how to reform the process for reviewing applications for tax-exempt status under Section 501(c) (4) to ensure it was untainted by partisan bias. It recommended that the IRS wait until existing investigations into past allegations about political bias in the screening of applications were resolved before issuing new regulations.
+
+ Several other varieties of tax fraud drew the attention of the committee as well. One was the recent growth in the number of fraudulent tax returns filed under a prisoner's Social Security number. The committee urged the IRS to continue working with the Federal Bureau of Prisons and state Departments of Correction on more effective ways to prevent such fraud. 
+
+ Fraudulent claims for the EITC were another concern. Improper EITC payments rose from $10.5 billion in FY2003 to about $18.0 billion in FY2014. According to the GAO, two factors accounted for these payments: (1) the difficulty some taxpayers experienced in determining by themselves if they are eligible for the credit and (2) the limited ability of the IRS to verify eligibility before refunds were issued. 49 The committee recommended that the IRS expand its education programs for taxpayers and professional tax preparers to improve compliance with the credit. 
+
+ On the issue of processing applications for the federal employment tax status of workers under the SS-8 program, the committee urged the IRS to maintain adequate staffing to meet the program's growing workload. The classification of a worker as an independent contractor or employee has significant tax implications for employers, workers, and the IRS. At issue is whether an individual or an employer is responsible for paying Social Security, Medicare, and federal unemployment taxes, and for withholding federal income taxes. In 1994, the IRS established what was then called the Determination of Worker Status Program to permit an employer or a worker to request an IRS determination of a worker's status as an employee or independent contractor; the program is now known as the SS-8 program. According to a 2013 TIGTA report, the inventory of cases and processing times increased from FY2009 to FY2012. 50 In January 2012, the IRS began to use a new method for prescreening requests for worker status determinations designed to speed up the process. The committee directed the IRS to notify the House and Senate Appropriations Committees, the Ways and Means Committee, and the Senate Finance Committee before reducing or reassigning staff for the program.
+
+ Operations Support 
+
+ S. 1910 would have provided $3.468 billion in appropriations for operations support in FY2016, or $170 million less than the amount enacted for FY2015 and $1.275 billion less than the budget request. 
+
+ Most of the IRS's planned 20 major IT investments in FY2016 will be funded through the recommended appropriations. To maintain oversight of the results and costs of these investments, the committee directed the IRS to provide both appropriations committees and the GAO with quarterly reports on "major project activities" no later than 30 days after the end of each calendar quarter in 2016. The reports should discuss cumulative expenditures and the performance schedules for previous fiscal years, the costs and schedules for the previous three months, and the costs and schedules for the next three months, for the following IT projects: IRS.gov, Returns and Remittance Processing, EDAS/IPM, Information Returns and Document matching, E-services, Taxpayer Advocate Service Integrated System, and implementation of the ACA. In addition, each report should explain when the projects began, their expected dates of completion, the percentage of work already completed, the current usefulness of the technology, and any anticipated changes in the schedule for completion.
+
+ As a supplement to these reports, the committee ordered the Treasury Department to review IRS's IT investments every six months to "ensure the cost, schedule, and scope goals are transparent." It also directed the GAO to submit an annual report to both appropriations committees on the cost and results of all major IRS IT projects in FY2016.
+
+ Business Systems Modernization 
+
+ In its report on S. 1910 , the committee recommended that the BSM program receive $260.0 million in appropriations in FY2016, or $30 million less than the amount enacted for FY2015 and $119.2 million less than the budget request.
+
+ The committee expressed concern about the continuing risk of cost overruns and delays in getting the desired results from the BSM projects. To manage that risk, the committee directed the IRS to continue to submit quarterly reports in FY2016 on the cost and performance schedules for two projects: CADE2 and MeF. Both the Treasury Department and the GAO would also have to submit annual reports on the cost and results of the two projects.
+
+ Consolidated Appropriations Act, 2016
+
+ Taxpayer Services 
+
+ The act gave the IRS $2.156 billion in appropriations for taxpayer service in FY2016. Of that amount, at least $12 million was to be used for low-income taxpayer clinic grants, $6.5 million for the Tax Counseling for the Elderly Program, and $206 million for the operating expenses of the Taxpayer Advocate Service ($5 million of which was to be used for identity theft casework). In addition, the act specified that at least $15 million was set aside for the Volunteer Income Tax Assistance matching grant program, through the end of FY2017.
+
+ Enforcement 
+
+ The act provided $4.860 billion for enforcement activities in FY2016.
+
+ Operations Support 
+
+ The act gave the IRS $3.638 billion for operation support in FY2016. In addition, the IRS Official Time Program Unit must submit a report to the two appropriations committees within 90 days of the enactment of the act on the number of IRS employees who are members of the collective bargaining unit and the amount of official time they use to perform tasks related to their duties as members of that unit.
+
+ Business Systems Modernization 
+
+ The act provided $290 million for the BSM program in FY2016.
+
+ Administrative Provisions 
+
+ The act included 13 administrative provisions that applied exclusively to the IRS. Most of them had been added to previous appropriations acts affecting the Treasury Department. One provision had not been included in earlier acts: 
+ Section 113 provided an additional $290 million in appropriations to be used solely for the purpose of making "measureable" improvements in the LOS, the prevention of identity theft and related refund fraud, and the protection of taxpayer information from cyberattack. None of the money can be used until the IRS Commissioner submits a spending plan to the two appropriations committees. Nor can any of the money be used to implement the tax provisions in the ACA.
+ Issues for Congress
+
+ The proposals from the Obama Administration and the House and Senate Appropriations Committees for funding the IRS in FY2016 raised several issues that may reappear in future appropriations requests. Three of those issues are discussed here: 
+ Did the IRS need a larger budget relative to FY2015 to accomplish its strategic goals and effectively carry out its legal responsibilities?
+
+ Was there a sound rationale for the requested increase in FY2016 funding for enforcement and operations support related to the proposed adjustments to the program integrity caps for the IRS established by the BBEDCA?
+
+ Should Congress consider the return on investment from spending on IRS enforcement activities when deciding how much to appropriate for IRS operations?
+ Adequacy of the IRS Budget 
+
+ The Obama Administration contended that the IRS budget in FY2015 was insufficient in light of the agency's strategic goals, legal responsibilities, and mounting work load. To rectify that deficiency, it asked Congress to increase IRS appropriations by $1.986 billion in FY2016, relative to FY2015. 
+
+ Between FY2010 and FY2015, IRS appropriations fell $1.2 billion (or 9.9%) and staffing by about 13,000 FTEs (or 14.1%). These declines contributed to reductions in both the assistance the IRS provided to taxpayers so they could meet their tax obligations and the actions taken by the IRS to enforce tax laws, including measures to curb tax evasion and refund fraud born of identity theft. During the 2015 filing season, over 60% of calls to the IRS's toll-free telephone taxpayer assistance lines went unanswered; the average wait time for those who got through was 23 minutes; and IRS assistors were allowed to answer basic tax questions only. Audit rates for all individual and business tax returns in FY2014 dropped to their lowest level since FY2005. And IRS's staff involved in enforcement decreased by 7,600 persons (or 18%) from FY2010 to FY2014.
+
+ At the same time, the IRS's work load grew considerably. From FY2010 to FY2015, the number of individual tax returns filed with the IRS rose seven million (or 5.0%). The IRS had to take on two new major responsibilities: implementing the ACA and FATCA. And cases involving identity theft increased 700% from FY2010 to FY2013.
+
+ In 2015, the IRS Commissioner, the National Taxpayer Advocate, TIGTA, and GAO issued statements calling for an increase in IRS funding. A primary concern was that continued declines in the resources available to the IRS would further diminish the effectiveness of taxpayer services, delay or cancel the implementation of critical new business systems, increase levels of tax evasion and identity theft, make the IRS more vulnerable to cyberattacks aimed at stealing taxpayer information, and undermine taxpayer confidence in the fairness and efficacy of the federal income tax system.
+
+ But critics of the IRS, including some leaders in the House and Senate, argued that the IRS needed to demonstrate that it was using available resources as effectively as possible and that it was taking advantage of opportunities for greater program efficiencies and cost savings, before increases in its budget could be considered. They maintained that with careful planning and strategic uses of the hundreds of millions of dollars in user fees the IRS collected each year, it should be able to meet its mandated responsibilities and make significant progress in achieving its strategic objectives.
+
+ In deciding how much money to appropriate for the IRS in the future, Congress may want to consider the implications of budget proposals for the ability of the IRS to efficiently and effectively meet its statutory responsibilities and to achieve its strategic goals, including a reduction in the federal tax gap and an improvement in the integrity of a tax system that relies on voluntary compliance to raise needed revenue.
+
+ Increased Funding for Enforcement T hrough Program Integrity Cap Adjustments 
+
+ The Budget Control Act of 2011 (BCA, P.L. 112-25 ) amended the BBEDCA by reinstating limits on discretionary budget authority that had lapsed at the end of FY2002. The current limits apply from FY2012 to FY2021. Section 251(b) (2) of the BBEDCA authorizes certain adjustments to the spending caps after the enactment of appropriations. Under the BCA, the limits on discretionary spending can be adjusted for six reasons:
+ 1. changes in budget concepts and definitions,
+
+ 2. appropriations designated for requirements for emergencies,
+
+ 3. appropriations designated for Overseas Contingency Operations/Global War on Terrorism,
+
+ 4. appropriations for continuing disability reviews and redeterminations,
+
+ 5. appropriations for controlling health care fraud and abuse, and
+
+ 6. appropriations for disaster relief.
+ The adjustments for health care fraud and abuse and for disability reviews and eligibility redeterminations allow for additional appropriations to carry out program integrity initiatives, which are activities intended to bring about a net reduction in federal spending, in part through reductions in improper benefit payments. In each case, the adjustment must exceed a specified minimum amount of appropriations for those activities and cannot exceed a specified maximum amount. Those amounts vary from year to year between FY2012 and FY2021. This budget mechanism is intended to ensure that the additional funding does not supplant other federal spending on these activities or is not diverted to other purposes.
+
+ The Obama Administration asked Congress to provide more funding for IRS enforcement activities and operations support in FY2016 through a program integrity cap adjustment for collecting taxes (and related penalties and interest charges) owed but not paid and reducing improper refund payments. 51 The request would have amended the BCA to allow an adjustment to the discretionary spending limits for the IRS from FY2016 to FY2025. In FY2016, the adjustment would have totaled $667 million in budget authority and outlays; over the entire period, the cap adjustments would have added $18.716 billion in BA and $18.570 billion in outlays. According to an IRS estimate, the cap adjustments would have led to the collection of $432 million in added tax revenue in FY2016 and $59.735 billion in added revenue from FY2016 to FY2025. This estimate assumed that one additional dollar in enforcement spending eventually would result in $6 in additional revenue, mostly from the collection of delinquent taxes.
+
+ Every budget request for the IRS since FY2006 has included a program integrity cap adjustment for IRS enforcement funding. Congress enacted such a proposal for FY2006, FY2009, and FY2010. Enacted cuts in IRS appropriations since then did not include any of the requested program integrity cap adjustments from FY2011 to FY2015. In an effort to make further reductions in the federal tax gap and foster increased tax compliance, Congress may want to assess the advantages and disadvantages of funding IRS's enforcement activities partly through such an adjustment, as part of its consideration of future budget requests.
+
+ Revenue Effects of Changes in IRS Appropriations 
+
+ Under current federal budget scorekeeping rules, any budgetary savings (such as increased revenue) from additional appropriations for government administrative programs is not counted as an offset to that spending. This rule goes back to the scorekeeping guidelines included in the conference report for the Omnibus Budget Reconciliation Act of 1990 ( P.L. 101-508 ) and reaffirmed in the conference report for the Balanced Budget Act of 1997 ( P.L. 105-33 ). The guidelines are intended to ensure the consistent treatment of the budgetary effects of government programs over time. None of the guidelines can be changed without the unanimous consent of all budget scorekeepers: the House and Senate Budget Committees, the Congressional Budget Office (CBO), and the Office of Management and Budget. 
+
+ For the enforcement activities of the IRS, this convention means that even though the activities raise additional revenue, the additional receipts cannot be used under congressional pay-go rules to finance tax cuts or spending increases. For example, a proposed decrease in IRS funding of 50% from the amount enacted in FY2015 would be scored as a reduction in the baseline federal budget deficit of approximately $5.4 billion in FY2016; by contrast, a proposed 50% increase in FY2016 funding would be treated as an increase in the federal budget deficit of the same amount. In both cases, even if the proposed changes would affect IRS's enforcement activities only, the increase or decrease in receipts would not affect the projected federal budget deficit.
+
+ This limitation also applies to the budgetary impact of other government compliance activities, such as measures to prevent improper Medicare payments or improper claims for federal student loans. In the view of some, a key justification for the limitation is that it deters federal agencies with enforcement budgets from shifting resources to collection functions to justify requests for larger budgets for their programs. 52 
+
+ By contrast, estimates of the revenue effects of legislative proposals to alter tax laws sometimes reflect both the indirect and dynamic revenue effects. H.Res. 5 (Adopting Rules for the 114 th Congress) requires the CBO and Joint Committee on Taxation (JCT) to incorporate the macroeconomic effects of major legislation in their official estimates of the cost effect used to enforce the budget resolution and other House rules. Major legislation is defined as legislation with a "gross budgetary effect" equal to or greater than 0.25% of the projected GDP for the fiscal year to which the budget resolution applies. 
+
+ Some argue that the current practice of disregarding the revenue effects of changes in IRS funding constitutes a bias that inclines Congress to appropriate less than it otherwise would, especially for collection activities. 53 A change in IRS funding may affect taxpayer compliance in ways that generate an indirect revenue effect. But this effect is not scored. Yet the JCT does score the indirect revenue effects of proposed tax code changes.
+
+ Congress may wish to consider the net contribution of IRS's administration of the federal tax code to the federal budget when deciding on the size of future IRS budgets. 
+
+ 
+
+ 
+
+ 
+ Author Contact Information
+ 
+ [author name scrubbed], Analyst in Public Finance
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ For more information see CRS Report R41427, Troubled Asset Relief Program (TARP): Implementation and Status , by [author name scrubbed].
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ U.S. Department of the Treasury, Community Development Financial Institutions Fund: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), p. 3.
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ For more details, see http://www.treasury.gov/about/budget-performance/CJ15/01.%20DO%20e.pdf .
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ U.S. Congress, House Appropriations Committee, Financial Services and General Government Appropriations Bill, 2016 , report to accompany H.R. 2995 , 114 th Cong. 1 st sess., H.Rept. 114-194 (Washington, DC: GPO, 2015), pp. 8-11.
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ U.S. Congress, Senate Appropriations Committee, Financial Services and General Government Appropriations Bill, FY2016 , report accompanying S. 1910 , 114 th Cong. 1 st sess., S.Rept. 114-97 (Washington, DC: GPO, 2015), p. 10.
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ U.S. Department of the Treasury, Department-Wide Systems and Capital Investments Program : FY 2016 President's Budget (Washington, DC: Feb. 2, 2015), p. 3, available at http://www.treasury.gov/about/budget-performance/CJ16/08.%20DSCIP%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ U.S. Department of the Treasury, Office of Inspector General: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/09.%20OIG%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 12.
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 15.
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ Department of the Treasury, Special Inspector for TARP: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/10.%20SIGTARP%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ Treasury Department, SIGTARP: FY2016 Budget, p. 12.
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 13.
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 18.
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ U.S. Department of the Treasury, Treasury Inspector General for Tax Administration: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), p. 3, available at http://www.treasury.gov/about/budget-performance/CJ16/11.%20TIGTA%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ Ibid., p. 5.
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 13.
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 17.
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ For more information on the fund, see CRS Report R42770, Community Development Financial Institutions (CDFI) Fund: Programs and Policy Issues , by [author name scrubbed]. 
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ U.S. Department of the Treasury, Community Development Financial Institutions Fund: FY 2016 President's Budget (Washington, DC: Feb. 2, 2015(, available at http://www.treasury.gov/about/budget-performance/CJ16/12.%20CDFI%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ Ibid, p. 3.
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ Ibid., p. 23.
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 18.
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 23.
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ U.S. Department of the Treasury, Financial Crimes Enforcement Network: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), p. 3, available at http://www.treasury.gov/about/budget-performance/CJ16/13.%20FinCEN%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 14.
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 19.
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ U.S. Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/14.%20TTB%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ This amount would result from a transfer of funds from the IRS through a program integrity cap adjustment to the IRS's budget for tax enforcement and compliance The cap adjustments have their origin in the Budget Enforcement Act of 1990 ( P.L. 101-508 ). For more details, see CRS Report R41901, Statutory Budget Controls in Effect Between 1985 and 2002 , by [author name scrubbed]; and CRS Report R41965, The Budget Control Act of 2011 , by [author name scrubbed], [author name scrubbed], and [author name scrubbed]. 
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ Alcohol and Tobacco Tax and Trade Bureau, FY2016 President's Budget , pp. 5-6.
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 16.
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ Ibid., p. 17.
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 21.
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ U.S. Department of the Treasury, Bureau of the Fiscal Service: FY 2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/15.%20FS%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ Ibid., pp. 14-15.
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 16.
+
+ 
+ 
+ 
+ 36 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 20.
+
+ 
+ 
+ 
+ 37 .
+ 
+ 
+ U.S. Department of the Treasury, Treasury Forfeiture Fund: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/23.%20TEOAF%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 38 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 15.
+
+ 
+ 
+ 
+ 39 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 20.
+
+ 
+ 
+ 
+ 40 .
+ 
+ 
+ U.S. Department of the Treasury, Internal Revenue Service: FY 2016 President's Budget (Washington, DC: Feb. 2, 2015), available at http://www.treasury.gov/about/budget-performance/CJ16/02-06.%20IRS%20FY%202016%20CJ.pdf .
+
+ 
+ 
+ 
+ 41 .
+ 
+ 
+ Treasury, Internal Revenue Service: FY 2016 President's Budget , p. 7.
+
+ 
+ 
+ 
+ 42 .
+ 
+ 
+ Ibid., p. 15.
+
+ 
+ 
+ 
+ 43 .
+ 
+ 
+ House Appropriations Committee, H.Rept. 114-194 , p. 18.
+
+ 
+ 
+ 
+ 44 .
+ 
+ 
+ Ibid., p. 19.
+
+ 
+ 
+ 
+ 45 .
+ 
+ 
+ For more details on the design and effectiveness of the credit, see CRS Report R44057, The Earned Income Tax Credit (EITC): An Economic Analysis , by [author name scrubbed].
+
+ 
+ 
+ 
+ 46 .
+ 
+ 
+ Senate Appropriations Committee, S.Rept. 114-97 , p. 27.
+
+ 
+ 
+ 
+ 47 .
+ 
+ 
+ Department of the Treasury, Treasury Inspector General for Tax Administration, Reduced Budgets and Collection Resources Have Resulted in Declines in Taxpayer Service, Case Closures, and Dollars Collected (Washington, DC: May 8, 2015), p. 10.
+
+ 
+ 
+ 
+ 48 .
+ 
+ 
+ Ibid., p. 11.
+
+ 
+ 
+ 
+ 49 .
+ 
+ 
+ U.S. Government Accountability Office, Fiscal Outlook: Addressing Improper Payments and the Tax Gap Would Improve the Government's Fiscal Position , GAO-16-92T (Washington: Oct. 1, 2015), p. 14.
+
+ 
+ 
+ 
+ 50 .
+ 
+ 
+ Department of the Treasury, Treasury Inspector General for Tax Administration, Employers Do Not Always Follow Internal Revenue Service Worker Determination Rulings (Washington, DC: June 14, 2013), p. 7.
+
+ 
+ 
+ 
+ 51 .
+ 
+ 
+ Department of the Treasury, Internal Revenue Service: FY2016 President's Budget (Washington, DC: Feb. 2, 2015), p. 14.
+
+ 
+ 
+ 
+ 52 .
+ 
+ 
+ Eric Toder, Reducing the Tax Gap: The Illusion of Pain-Free Deficit Reduction (Washington, DC: Urban Institute and the Urban-Brookings Tax Policy Center, July 3, 2007), available at http://www.urban.org/research/publication/reducing-tax-gap-illusion-pain-free-deficit-reduction .
+
+ 
+ 
+ 
+ 53 .
+ 
+ 
+ Patrick Driessen, "Scoring Rules Double-Stacked Against IRS Funding," Tax Notes , Mar. 30, 2015.
\ No newline at end of file
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+Enforceable Spending Allocations in the 
+
+January 18, 2023 
+
+ Congressional Budget Process: 302(a)s and 
+
+ Drew C. Aherne 
+
+ 302(b)s 
+
+Analyst on Congress and 
+the Legislative Process 
+
+The Congressional Budget Act of 1974 (the Budget Act) stipulates a system for enforcing the 
+
+ 
+
+spending levels established in the budget resolution that focuses on the individual committees 
+and subcommittees that make budgetary decisions. 
+
+ 
+
+The Budget Act requires that the total spending levels set forth in the budget resolution be allocated among all committees 
+with jurisdiction over spending legislation. The Budget Act also requires that the Committees on Appropriations in the House 
+and Senate subdivide their total allocations among their subcommittees. Once reported, these suballocations effectively 
+establish separate enforceable levels for each of the 12 regular appropriations bills. These allocations are known as “302(a)” 
+allocations and “302(b)” suballocations, respectively, based on the sections of the Budget Act that establish the requirements. 
+These allocations and suballocations serve as the primary means of enforcement for spending levels in the congressional 
+budget process. 
+
+The 302(a) and 302(b) levels are not self-enforcing. Members can enforce them by raising points of order during the 
+consideration of budgetary legislation. The Budget Act establishes multiple points of order for enforcing 302(a) and 302(b) 
+levels, including prohibitions on the consideration of budgetary measures in the absence of 302 allocations and the 
+consideration of legislation that would cause spending to exceed the allocations. Budget Act points of order enforcing 302(a) 
+and 302(b) levels can be waived in the House and Senate, and each chamber has different procedures for doing so. 
+
+Congress has historically allowed for adjustments to or revisions of budgetary aggregates and 302 allocations under certain, 
+specified circumstances. For example, these levels are adjusted to accommodate spending designated as an emergency, 
+effectively exempting it from budget enforcement. In some cases, Congress has also given authority to adjust budget 
+aggregates and allocations to accommodate certain specified budgetary legislation through “reserve fund” provisions in 
+budget resolutions. In the case of 302(b) suballocations, the Budget Act provides that the Appropriations Committees may 
+revise their suballocations. 
+
+Congressional Research Service 
+
+ 
+
+ 
+ link to page 4 link to page 4 link to page 4 link to page 5 link to page 8 link to page 10 link to page 10 link to page 12 link to page 6 link to page 7 link to page 8 link to page 13 link to page 13 link to page 14 link to page 15 link to page 11 link to page 15 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Contents 
+
+ Introduction ............................................................................................................................... 1 
+The Budget Resolution, Spending Levels, and Committee Allocations ................................... 1 
+
+ The Budget Resolution ....................................................................................................... 1 
+ 302(a) Allocations and 302(b) Suballocations .................................................................... 2 
+ 302 Allocations in Relation to Direct and Discretionary Spending .................................... 5 
+ 302(a)s and 302(b)s in Years Without a Budget Resolution ............................................... 7 
+
+ Enforcement of 302(a)s and 302(b)s ......................................................................................... 7 
+ Adjustments and Revisions ....................................................................................................... 9 
+
+ 
+
+ Figures 
+ Figure 1. 302(a) Example ................................................................................................................ 3 
+ Figure 2. Appropriations Committee 302(a) Example .................................................................... 4 
+ Figure 3. 302(b) Example ................................................................................................................ 5 
+ Figure 4. 302(a) Discretionary Adjustment Example .................................................................... 10 
+Figure 5. 302(b) Adjustment Example .......................................................................................... 10 
+ Figure 6. Reserve Fund Example ................................................................................................... 11 
+ Figure 7. Reserve Fund Adjustment Example ............................................................................... 12 
+ 
+
+ Tables 
+ Table 1. Budget Act Points of Order Enforcing 302(a)s and 302(b)s .............................................. 8 
+ 
+
+ Contacts 
+ Author Information ........................................................................................................................ 12 
+ 
+
+Congressional Research Service 
+
+ 
+
+ 
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Introduction 
+ The Congressional Budget Act of 1974 (the Budget Act) provides for the adoption of a concurrent 
+resolution on the budget to serve as an agreement between the House and Senate on a budget plan 
+for the upcoming fiscal year (and at least four fiscal years thereafter).1 The budget resolution, 
+among other things, allows Congress to establish a fiscal framework for the consideration of 
+legislation affecting the federal budget. As a concurrent resolution, the budget resolution is not 
+signed into law and does not make direct changes to spending and revenues. Furthermore, it 
+represents a broad budget framework that does not allocate funds to specific programs or 
+accounts. Instead, the Budget Act establishes various procedural and legislative mechanisms that 
+allow Congress to enforce the budgetary levels adopted in the budget resolution. One such 
+mechanism is the enforcement of spending levels on a committee-by-committee basis through 
+allocations established in relation to the budget resolution. 
+
+The Budget Act requires that Congress allocate the aggregate spending levels set forth in the 
+budget resolution among committees in the House and Senate with jurisdiction over spending 
+legislation (commonly referred to as “302(a)” allocations). The Budget Act also requires the 
+Appropriations Committees in the House and Senate to subdivide their 302(a) allocations among 
+their subcommittees to create enforceable levels for each of the regular, annual appropriations 
+bills (commonly referred to as “302(b)” suballocations).2 These allocations and suballocations 
+can be enforced through points of order raised by Members during the consideration of budgetary 
+legislation on the House or Senate floor and serve as the primary means of enforcing spending 
+levels in the congressional budget process. 
+
+This report provides an overview of the use of 302(a) allocations and 302(b) suballocations as 
+enforceable spending limits in the congressional budget process. First, it discusses 302 allocations 
+in the context of the budget resolution and spending levels more generally, as well as the 
+processes for making them both as established in the Budget Act and in recent practice. Next, it 
+discusses the enforcement of 302(a)s and 302(b)s through points of order and the processes for 
+waiving their application in the House and Senate. Lastly, it outlines the contexts within which 
+Congress generally allows for revisions or adjustments to 302(a)s and 302(b)s. 
+
+ The Budget Resolution, Spending Levels, and Committee 
+Allocations 
+
+ The Budget Resolution 
+
+The Budget Act provides for the adoption of a concurrent resolution on the budget to set forth 
+budgetary parameters and coordinate budgetary decisions for the upcoming fiscal year.3 The 
+Budget Act requires that the budget resolution include a number of budgetary levels for the 
+upcoming fiscal year and at least the four ensuing fiscal years, including: 
+
+ total new budget authority and outlays; 
+
+ 
+1 Titles I-IX of P.L. 93-344, codified as amended at 2 U.S.C. §601-§661f. 
+2 These allocations and suballocations are known as “302(a)” allocations and “302(b)” suballocations, respectively, 
+based on the sections of the Budget Act that establish the requirements. Sections 302(a) and 302(b) of the Budget Act, 
+codified as amended at 2 U.S.C. §633. 
+
+3 Section 301 of the Budget Act, codified as amended at 2 U.S.C. §632. For more on budget resolutions, see CRS 
+Report R47336, Content and Consideration of the Budget Resolution: In Brief , by Sarah B. Solomon. 
+
+Congressional Research Service 
+
+ 
+
+1 
+
+ 
+ link to page 6 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ total federal revenues and, if necessary, the amount by which the total is to be 
+
+changed by legislative action; 
+
+ the surplus or deficit; 
+ new budget authority and outlays for each major functional category (based on 
+
+the total levels set forth); 
+
+ the public debt; and 
+ outlays and revenues of the Social Security trust funds.4 
+
+As already noted, the Budget Act establishes procedural mechanisms that allow Congress to 
+enforce the budgetary levels adopted in the budget resolution while considering legislation over 
+the course of a fiscal year. One of the primary mechanisms for doing so is based on enforceable 
+spending levels, allocated from the aggregate levels set forth in the budget resolution, to the 
+individual committees that make spending decisions. 
+
+ 302(a) Allocations and 302(b) Suballocations 
+
+ 302(a) Allocations 
+ Section 302(a) of the Budget Act requires that the total spending levels adopted in the budget 
+resolution be allocated among each committee in the House and Senate with jurisdiction over 
+spending legislation. These allocations are required to cover both the upcoming fiscal year and at 
+least the four ensuing fiscal years for all committees other than the Committees on 
+Appropriations. In practice, allocations to these committees generally cover the whole budget 
+window included in the budget resolution, which has often been 10 fiscal years in recent budget 
+resolutions. The Budget Act requires that allocations made to the House and Senate Committees 
+on Appropriations cover only the upcoming fiscal year. 
+
+The Budget Act establishes that 302(a) allocations be included in the joint explanatory statement 
+accompanying a House-Senate conference report on the budget resolution. Recent practice, 
+however, has most often been for the budget resolution (or an alternative legislative measure) to 
+include instructions for the chairs of the House and Senate Budget Committees to submit a 
+statement containing 302(a) allocations for printing in the Congressional Record .5 The Budget 
+Act does not specify an exact format for 302(a) allocations, and their presentation may vary 
+between the House and Senate in some years. Despite any potential differences, all 302(a) 
+allocations contain total budget authority and outlays for the required period for all House and 
+Senate committees with jurisdiction over spending legislation. See Figure 1 for an example of 
+302(a) allocations printed in the Congressional Record . 
+
+ 
+4 These amounts are set forth separately in the budget resolution for enforcement purposes in the Senate. The Social 
+Security trust funds are considered off-budget and are not reflected in the aggregate spending and revenue amounts in 
+the budget resolution. 
+
+5 In recent years, 302(a) allocations in the House have been printed in the Congressional Record under the heading 
+“Publication of Budgetary Material.” In the Senate, they have been printed under various headings in recent years, 
+including “Budget Committee Submissions,” “Fiscal Year 2018 Enforcement Filing,” “Enforcing Budgetary Levels for 
+Fiscal Year 2020,” and “Budget Enforcement Levels for Fiscal Year 2021,” among others. 
+
+Congressional Research Service 
+
+ 
+
+2 
+
+ 
+ link to page 7 link to page 8 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Figure 1. 302(a) Example 
+
+Senate FY2022 Excerpt 
+
+ 
+
+ Source: Congressional Record , daily edition, vol. 167, no. 165 (September 23, 2021), pp. S6667-S6668. 
+ Notes: For ease of readability, this figure does not show 302(a) al ocations made to all Senate committees for 
+FY2022. Congress enacted S.Con.Res. 14, the concurrent resolution on the budget for FY2022, on August 24, 
+2021. Section 4006 of S.Con.Res. 14, in part, instructed the chairs of the House and Senate Budget Committees 
+to submit a statement for publication in the Congressional Record containing 302(a) allocations to committees for 
+FY2022. On September 23, 2021, the chairman of the Senate Budget Committee submitted the above 302(a) 
+allocations for printing in the Congressional Record . 
+
+ 302(b) Suballocations 
+ Section 302(b) of the Budget Act requires that the House and Senate Appropriations Committees 
+further divide their 302(a) allocation among their subcommittees. The House and Senate 
+Appropriations Committees currently have 12 identical subcommittees, each responsible for 
+developing one of the regular, annual appropriations bills.6 These 302(b) suballocations 
+effectively establish separate enforceable levels for each of the regular appropriations bills. The 
+House and Senate Appropriations Committees each meet as a full committee to adopt and report 
+302(b) suballocations, which contain the required total budget authority and outlays for the 
+upcoming fiscal year for each subcommittee.7 Figure 2 and Figure 3 provide an example of a 
+302(a) allocation to the House Appropriations Committee as well as the associated 302(b)s to its 
+subcommittees. 
+
+ 
+6 For more on the subcommittee structure of the House and Senate Appropriations Committees, see CRS Report 
+RL31572, Appropriations Subcommittee Structure: History of Changes from 1920 to 2021 , by James V. Saturno. 
+
+7 Senate 302(b) suballocations have also distinguished between security and non-security discretionary spending for 
+informational purposes in recent fiscal years. 
+
+Congressional Research Service 
+
+ 
+
+3 
+
+ 
+ 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Figure 2. Appropriations Committee 302(a) Example 
+
+House FY2022 
+
+ 
+
+ Source: Congressional Record , daily edition, vol. 167, no. 110 (June 24, 2021), pp. H3130. 
+ Notes: The House adopted H.Res. 467 on June 14, 2021. Section 1 of H.Res. 467, in part, directed the chairman 
+of the House Budget Committee to submit a statement for publication in the Congressional Record containing the 
+302(a) allocation for the Committee on Appropriations for FY2022. On June 24, 2021, the chairman of the 
+House Budget Committee submitted the above 302(a) allocation to the Appropriations Committee for printing 
+in the Congressional Record . 
+
+Congressional Research Service 
+
+ 
+
+4 
+
+ 
+ link to page 7 link to page 7 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Figure 3. 302(b) Example 
+
+House FY2022 
+
+ 
+
+ Source: H.Rept. 117-78, p. 2. 
+ Notes: The House Committee on Appropriations reported the 302(b) suballocations for its subcommittees 
+associated with the 302(a) allocation in Figure 2 on July 1, 2021. The budgetary totals made up from these 
+302(b) suballocations—including for discretionary budget authority and outlays, mandatory budget authority and 
+outlays, and total budget authority and outlays—are identical to those established in the 302(a) allocation in 
+ Figure 2 . 
+
+ 302 Allocations in Relation to Direct and Discretionary Spending 
+
+Congress distinguishes between two types of spending for budget enforcement purposes, direct 
+(or mandatory) spending and discretionary spending.8 Direct spending is generally defined as any 
+budget authority provided in a law other than an appropriations act.9 This type of spending 
+commonly takes the form of a requirement for the government to make payments to eligible 
+
+ 
+8 For more on the types of spending in the federal budget, see CRS Report R44582, Overview of Funding Mechanisms 
+in the Federal Budget Process, and Selected Examples , by Jessica Tollestrup. 
+
+9 Section 250(c)(8) of the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA, P.L. 99-351) 
+defines direct spending as (a) budget authority provided by law other than appropriations acts, (b) entitlement authority, 
+and (c) the Supplemental Nutrition Assistance Program. 
+
+Congressional Research Service 
+
+ 
+
+5 
+
+ 
+ link to page 7 link to page 8 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+recipients according to a formula that establishes criteria and benefits (known as an entitlement, 
+such as Medicare). Direct spending makes up around two-thirds of federal spending and is 
+controlled through authorizing statutes, which are within the jurisdiction of the legislative 
+committees of Congress (such as the Senate Finance Committee and the House Energy and 
+Commerce Committee). Although direct spending programs can be established in permanent laws 
+that provide budget authority until they are revised or terminated, some programs sunset or 
+expire, and to continue, they must be re-authorized or extended through newly enacted legislation 
+(such as the Children’s Health Insurance Program or the Temporary Assistance for Needy 
+Families program). 
+
+Congress uses an existing-law baseline for informational and scoring purposes. The baseline is a 
+projection of federal spending, revenues, and the deficit or surplus that are estimated to occur if 
+current laws are maintained into the future, adjusted for various economic and technical 
+assumptions. The baseline plays a role in determining the budgetary levels set forth in the budget 
+resolution, including the associated 302(a) allocations. Since direct spending generally continues 
+each year barring any changes to the laws that control it, the majority, if not all, of a legislative 
+committee’s 302(a) allocation may consist of spending already assumed to occur under the 
+baseline. A legislative committee’s 302(a) allocation signals how the budgetary levels adopted in 
+the budget resolution fit Congress’s legislative agenda with respect to issues within a committee’s 
+jurisdiction. For example, a 302(a) allocation above baseline levels may allow a committee to 
+consider legislation that would increase direct spending under its jurisdiction (such as expanding 
+or creating programs or activities within its jurisdiction). 
+
+Discretionary spending makes up roughly one-third of federal spending and is controlled through 
+appropriations acts within the jurisdiction of the House and Senate Committees on 
+Appropriations. The appropriations process occurs on an annual basis, with budget authority for 
+discretionary spending typically determined for each fiscal year through the 12 regular 
+appropriations bills.10 Congress sets the total enforceable limit for spending contained in the 
+regular appropriations bills through the 302(a) allocations to the House and Senate Appropriations 
+Committees. The Appropriations Committees are then required to set enforceable limits for each 
+of the 12 regular appropriations bills “as soon as practicable” through 302(b) suballocations to 
+their subcommittees. 
+
+The 302(b) suballocations serve as the primary enforcement mechanism for discretionary 
+spending in the congressional budget process. Each appropriations subcommittee in the House 
+and Senate receives a 302(b) suballocation, thus setting a top line limit for all discretionary 
+spending under its jurisdiction. Each appropriations bill must then fund the agencies, programs, 
+and activities under its jurisdiction at levels that, in total, do not exceed its subcommittee’s 302(b) 
+suballocation. Regular appropriations bills also provide budget authority to finance some direct 
+spending programs (known as appropriated entitlements). Spending on appropriated entitlements 
+is reflected in the amount allocated to the Appropriations Committees as well as their 
+suballocations. The Budget Act requires that allocations be divided between direct and 
+discretionary amounts (as seen i n Figure 2 an d Figure 3 ) , though only the overall level of each 
+302(b) suballocation is enforceable. 
+
+ 
+10 For more on the appropriations process, see CRS Report R47106, The Appropriations Process: A Brief Overview , by 
+James V. Saturno and Megan S. Lynch. 
+
+Congressional Research Service 
+
+ 
+
+6 
+
+ 
+ link to page 11 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ 302(a)s and 302(b)s in Years Without a Budget Resolution 
+
+Congress has not always adopted a concurrent resolution on the budget, including in 11 of the 20 
+fiscal years between FY2003 and FY2022. In these years, Congress has used alternative 
+legislative measures to establish enforceable budget levels in accordance with the requirements 
+set forth in the Budget Act. These measures are collectively referred to as “deeming resolutions” 
+since they are deemed to serve in place of a budget resolution for the upcoming fiscal year.11 
+
+There is no formal definition or required content for deeming resolutions, and they have 
+historically varied in both form and function. Furthermore, the House and Senate have often 
+adopted deeming resolutions separately and, as a result, may work with different budget 
+aggregates for some part of the budget process. Despite variations, deeming resolutions all 
+include language setting forth certain budgetary levels and holding that such levels are to be 
+considered enforceable under the Budget Act as if they had been included in a budget resolution. 
+This includes the authority to establish and enforce 302(a) allocations. In recent years, the chairs 
+of the House and Senate Budget Committees have filed 302(a) allocations made in association 
+with deeming resolutions for printing in the Congressional Record . The House and Senate 
+Appropriations Committees generally follow the same practice for 302(b) suballocations under a 
+deeming resolution as they would under a budget resolution. 
+
+ Enforcement of 302(a)s and 302(b)s 
+ Allocations made in association with the budget resolution are not self-enforcing. A Member must 
+raise a point of order on the floor of the chamber during consideration of budgetary legislation 
+before the presiding officer can rule on its application and, thus, for its enforcement.12 Broadly, 
+points of order are prohibitions against the consideration or content of certain legislation, 
+amendments, or congressional action.13 Congress has created a number of points of order for the 
+purposes of budget enforcement through the Budget Act and various budget resolutions. This 
+includes points of order enforcing the budgetary levels set forth in the budget resolution, with 
+302(a) and 302(b) levels generally serving as the primary focus of enforcement.14 
+
+Budget Act points of order enforcing 302(a) and 302(b) levels may influence the timing of 
+consideration and the budgetary effect of spending legislation either directly through their use on 
+the floor or indirectly through the potential for their use. Budget Act points of order generally 
+enforce 302(a) and 302(b) levels by creating certain prohibitions on the consideration of 
+budgetary measures. This includes prohibitions on the consideration of certain budgetary 
+measures before allocations are made, as well as prohibitions on the consideration of legislation 
+or amendments that would cause spending levels to exceed the allocations. Table 1 identifies 
+points of order established by the Budget Act associated with the enforcement of 302(a)s and 
+302(b)s. 
+
+ 
+11 For more on deeming resolutions, see CRS Report R44296, Deeming Resolutions: Budget Enforcement in the 
+Absence of a Budget Resolution , by Megan S. Lynch. 
+
+12 For more on points of order in the congressional budget process, see CRS Report 97-865, Points of Order in the 
+Congressional Budget Process , by James V. Saturno. 
+
+13 For more on points of order in the House and Senate, see CRS Report 98-307, Points of Order, Rulings, and Appeals 
+in the House of Representatives , by Valerie Heitshusen; and CRS Report 98-306, Points of Order, Rulings, and 
+Appeals in the Senate , by Valerie Heitshusen. 
+
+14 For example, although Section 311(a)(1) of the Budget Act establishes a point of order for enforcing aggregate 
+spending levels set forth in the budget resolution, Section 311(c) creates an exception in the House allowing aggregate 
+levels to be exceeded so long as a committee’s 302(a) allocation has not been breached. 
+
+Congressional Research Service 
+
+ 
+
+7 
+
+ 
+ link to page 11 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Table 1. Budget Act Points of Order Enforcing 302(a)s and 302(b)s 
+
+ Senate 
+
+ Section 
+
+ Description 
+
+ Waiver Vote 
+
+ Threshold 
+
+302(c) 
+
+In the House and Senate, prohibits the consideration of any 
+
+Three-fifths 
+
+measure within the jurisdiction of the Appropriations Committees 
+that provides new budget authority for a fiscal year until the 
+committees have made 302(b) suballocations to their 
+subcommittees (after the committees receive their 302(a) 
+allocations). 
+
+302(f)(1) 
+
+In the House, once a budget resolution has been adopted, prohibits 
+
+n/a 
+
+consideration of legislation providing new budget authority for any 
+fiscal year that would cause the allocation of new budget authority 
+made in the applicable 302(a)s or 302(b)s for the first fiscal year or 
+for the total of all fiscal years included in the budget resolution to 
+be exceeded. 
+
+302(f)(2)(a) 
+
+In the Senate, once a budget resolution has been adopted, prohibits 
+
+Three-fifths 
+
+consideration of legislation from any committee other than the 
+Appropriations Committee that would cause the allocation of new 
+budget authority or outlays made in the applicable 302(a) allocation 
+for the first fiscal year or for the total of all fiscal years included in 
+the budget resolution to be exceeded. 
+
+302(f)(2)(b) 
+
+In the Senate, once a budget resolution has been adopted, prohibits 
+
+Three-fifths 
+
+consideration of legislation from the Appropriations Committee 
+that would cause the allocation of new budget authority made in 
+the applicable 302(b) suballocation to be exceeded. 
+
+303(c) 
+
+In the Senate, prohibits consideration of any appropriations 
+
+Simple majority 
+
+measure until a budget resolution for that fiscal year has been 
+adopted and a 302(a) allocation to the Appropriations Committee 
+has been made. 
+
+ Source: The Congressional Budget Act of 1974, Titles I-IX of P.L. 93-344, codified as amended at 2 U.S.C. 
+§§601-688. 
+
+The House and Senate each have procedures for waiving Budget Act points of order. The Budget 
+Act sets forth procedures for waiving points of order under the act in the Senate.15 Under these 
+procedures, a Senator may make a motion to waive the application of a point of order either 
+before it can be raised or after one has been raised, but must do so before the presiding officer 
+rules on the merits of an already-raised point of order. The Budget Act also establishes vote 
+thresholds by which points of order under the act may be waived in the Senate. As indicated in 
+ Table 1 , m ost points of order related to the enforcement of 302(a) and 302(b) levels can be 
+waived by a vote of at least three-fifths of all Senators duly chosen and sworn (60 votes if there 
+are no vacancies). The three-fifths requirement for these points of order is temporary and 
+currently set to expire on September 30, 2025.16 Furthermore, a Budget Act point of order may 
+
+ 
+15 Section 904 of the Budget Act. 
+16 The three-fifths requirement for waiving Budget Act points of order was originally established in Section 271 of 
+BBEDCA (Title II of P.L. 99-177). The waiver procedure for Budget Act points of order was then amended by Section 
+10119 of the Balanced Budget Act of 1997 (P.L. 105-33), including a provision setting an expiration date for the three-
+fifths requirement of September 30, 2002. The three-fifths requirement—except for the point of order in Section 
+302(f)(2)(b)—was then extended through April 15, 2003, by Section 2 of S.Res. 304 (107th Congress). The 
+requirement, including the point of order in Section 302(f)(2)(b), was further extended through September 30, 2008, by 
+Section 503 of H.Con.Res. 95 (108th Congress); through September 30, 2010, by Section 403 of H.Con.Res. 95 (109th 
+
+Congressional Research Service 
+
+ 
+
+8 
+
+ 
+ link to page 13 link to page 13 Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+not be raised against a measure while an amendment that would remedy the violation is pending 
+before the Senate.17 
+
+The mechanism most commonly used by the House to waive Budget Act points of order is 
+through the adoption of special rules providing for the consideration of relevant bills. Special 
+rules require adoption through the affirmative vote of a majority of the House. Other means, such 
+as suspension of the rules or unanimous consent, may also be used to waive points of order. 
+Waivers in the House may be granted for a bill, specified provisions in a bill, or an amendment. 
+The House may grant a waiver for one or more specific points of order in a special rule, or it can 
+include a “blanket waiver” that would apply to all points of order that might otherwise be raised 
+against a bill, provision, or amendment. 
+
+ Adjustments and Revisions 
+ Historically, Congress has generally allowed for adjustments to the budget aggregates and 
+allocations associated with the budget resolution to accommodate certain spending. 
+
+The most commonly used adjustments to 302(a)s and 302(b)s are those related to certain 
+discretionary spending. The authority to adjust allocations to accommodate certain discretionary 
+spending originated in the Balanced Budget and Emergency Deficit Control Act of 1985.18 More 
+recently, however, this authority has most often been established in provisions adopted through 
+budget resolutions. These authorities allow relevant budgetary levels to be adjusted upward 
+during consideration of a measure containing certain, specified discretionary spending, effectively 
+exempting certain types of spending from budget enforcement. Some common examples of such 
+spending include that which Congress has designated to be for an emergency, disaster relief, or 
+overseas contingency operations. Congress has historically permitted adjustments for 
+discretionary spending related to other specified purposes as well, such as certain program 
+integrity activities.19 Congress may provide specific terms for some allowable adjustments, such 
+as including a specified dollar amount that adjustments may not exceed or only allowing them for 
+certain fiscal years.20 House and Senate Budget Committee chairs generally submit 302(a) 
+adjustments as a statement for printing in the Congressional Record , while the House and Senate 
+Appropriations Committees generally communicate the requisite adjustments to 302(b) levels 
+through committee reports . Figure 4 and Figure 5 provide an example of an adjustment to the 
+302(a) allocation to the House Appropriations Committee and the corresponding adjustment to its 
+302(b) levels to accommodate certain discretionary spending. 
+
+ 
+Congress); through September 30, 2017, by Section 205 of S.Con.Res. 21 (110th Congress); and through September 30, 
+2025, by Section 3201(a)(1) of S.Con.Res. 11 (114th Congress). 
+
+17 Section 312(d) of the Budget Act, codified as amended at 2 U.S.C. §643. 
+18 Section 251 of BBEDCA, codified as amended at 2 U.S.C. §901. 
+19 For example, Section 4004 of S.Con.Res. 14 (117th Congress), the budget resolution for FY2022, allows for the 
+adjustment of aggregates and allocations to accommodate spending on the health care fraud and abuse control program 
+at the Department of Health and Human Services. 
+
+20 For example, Congress established that the adjustment for the health care fraud and abuse control program at the 
+Department of Health and Human Services (described in footnote 19) may not exceed $556 million for FY2022. 
+
+Congressional Research Service 
+
+ 
+
+9 
+
+ 
+ link to page 13 
+
+ 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Figure 4. 302(a) Discretionary Adjustment Example 
+
+House Wildfire Suppression FY2023 (H.R. 8262) 
+
+ 
+
+ Source: Congressional Record , daily edition, vol. 168, no. 114 (July 12, 2022), pp. H5973. 
+ Notes: Section 1 of H.Res. 1151 (117th Congress), the House deeming resolution for FY2023, in part provides 
+for adjustments to allocations, aggregates, and other budgetary levels to accommodate discretionary 
+appropriations of up to $2,550,000,000 for wildfire suppression operations. On July 1, 2022, the House 
+Appropriations Committee reported H.R. 8262, the Department of the Interior, Environment, and Related 
+Agencies Appropriations Act for FY2023, which included $2,550,000,000 for wildfire suppression operations. On 
+July 12, 2022, the chair of the House Budget Committee submitted for printing in the Congressional Record 
+ adjustments to the 302(a) allocation to the House Appropriations Committee to accommodate certain 
+discretionary spending, including the $2,550,000,000 for wildfire suppression operations in H.R. 8262 (outlined in 
+red). 
+
+ Figure 5. 302(b) Adjustment Example 
+
+House Wildfire Suppression FY2023 (H.R. 8262) 
+
+ 
+
+ Source: H.Rept. 117-398, p. 2. 
+ Notes: On July 1, 2022, the House Appropriations Committee adjusted its 302(b) suballocations to 
+“incorporate anticipated adjustments to the Committee’s 302(a) al ocations for amounts provided for fiscal year 
+2023 in legislation that has been ordered reported by the Committee on Appropriations.” The committee 
+adjusted the 302(b) suballocation to the Interior, Environment, and Related Agencies Subcommittee upward by 
+$2,550,000,000 to accommodate the discretionary appropriations for wildfire suppression operations provided 
+in H.R. 8262 (117th Congress). The adjustments to the budget authority and outlays are identical to those made 
+to the ful committee’s 302(a) allocation in Figure 4 . Although Section 314 of the Budget Act establishes that 
+
+Congressional Research Service 
+
+ 
+
+10 
+
+ 
+ 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+adjustments to 302(b) suballocations should take place fol owing adjustments to the 302(a) allocation to the 
+Appropriations Committee, the House Appropriations Committee has sometimes reported adjusted 302(b) 
+levels prior to the adjustment of their 302(a) allocation in recent years. 
+
+Another way that Congress allows for adjustments to budgetary levels is through provisions in 
+budget resolutions providing for adjustments to accommodate legislation (most often involving 
+direct spending) under certain circumstances. Provisions permitting such adjustments are often 
+called “reserve funds” and generally allow for the adjustment of budget aggregates and 
+allocations if certain legislation is reported or if other conditions are met.21 Adjustments made in 
+association with a reserve fund provision may be exercised only under the circumstances and 
+budgetary parameters specified in the budget resolution. It is common for reserve funds to include 
+a requirement that the specified legislation be deficit-neutral, for example. Furthermore, the 
+inclusion of a reserve fund in a budget resolution does not mandate future action on the specified 
+legislation. Reserve fund provisions may indicate Congress’s intention to consider certain 
+legislation and accommodate its budgetary effects, but they have also generally been included in 
+budget resolutions for messaging purposes with no subsequent legislative action. Figure 6 and 
+ Figure 7 provide an example of a reserve fund provision included in a budget resolution and the 
+subsequent adjustment to 302(a) levels to accommodate legislation related to that reserve fund. 
+
+ Figure 6. Reserve Fund Example 
+
+Senate FY2022 (S.Con.Res. 14) 
+
+ 
+
+ Source: Section 3002 of S.Con.Res. 14 (117th Congress). 
+ Notes: Congress adopted S.Con.Res. 14, the concurrent resolution on the budget for FY2022, on August 24, 
+2021. Section 3002 of S.Con.Res. 14 included a reserve fund provision allowing the chairman of the Senate 
+Budget Committee to adjust committee allocations and aggregates to accommodate reconciliation legislation 
+pursuant to the instructions set forth in Section 2001 of the budget resolution. 
+
+ 
+21 For more on reserve funds, see CRS Report R47277, Reserve Funds in the Congressional Budget Process: 
+Frequently Asked Questions , by Megan S. Lynch. 
+
+Congressional Research Service 
+
+ 
+
+11 
+
+ 
+ 
+
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ Figure 7. Reserve Fund Adjustment Example 
+
+Senate FY2022 (S.Con.Res. 14) 
+
+ 
+
+ Source: Congressional Record , daily edition, vol. 168, no. 146 (September 12, 2022), pp. S4537. 
+ Notes: Congress enacted the Inflation Reduction Act (P.L. 117-169), a reconciliation act pursuant to the 
+instructions set forth in the FY2022 budget resolution, in August 2022. On September 12, 2022, the chairman of 
+the Senate Budget Committee filed a statement for printing in the Congressional Record making the requisite 
+adjustments to budgetary aggregates and the 302(a) allocations of eight committees to accommodate P.L. 117-
+169. As noted in the statement, the adjustment levels reflect cost estimates of the law provided by the 
+Congressional Budget Office. 
+
+Lastly, the Budget Act also provides authority for the House and Senate Appropriations 
+Committees to revise their 302(b) suballocations within the limits of their 302(a) allocations at 
+any time. This allows the Appropriations Committees to revise the enforceable level for each 
+appropriations bill to reflect developments during the appropriations process so long as the total 
+amount for all 12 subcommittees does not exceed their 302(a) allocations. The House and Senate 
+Appropriations Committees generally communicate revisions reported by their respective 
+committees through committee reports. 
+
+ 
+
+ Author Information 
+
+ 
+Drew C. Aherne 
+
+ 
+
+Analyst on Congress and the Legislative Process 
+ 
+
+Congressional Research Service 
+
+ 
+
+12 
+
+ 
+ Enforceable Spending Allocations in the Congressional Budget Process 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan 
+shared staff to congressional committees and Members of Congress. It operates solely at the behest of and 
+under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other 
+than public understanding of information that has been provided by CRS to Members of Congress in 
+connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not 
+subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in 
+its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or 
+material from a third party, you may need to obtain the permission of the copyright holder if you wish to 
+copy or otherwise use copyrighted material. 
+
+ 
+
+Congressional Research Service 
+
+R47388 · VERSION 1 · NEW 
+
+13
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+Asian Infrastructure Investment Bank (AIIB)
+
+ February 3, 2017
+ (R44754)
+ 
+ Jump to Main Text of Report 
+
+ 
+
+ 
+ 
+ Contents
+
+ 
+ Introduction 
+
+ China's Motivation for Creating the AIIB 
+
+ Reforming Global Economic Governance 
+
+ MDB and Chinese Financing of Infrastructure 
+
+ AIIB Membership and Operations 
+
+ Membership 
+
+ Governance 
+
+ AIIB's Board of Directors 
+
+ AIIB Presidency and Staff 
+
+ Capital Structure 
+
+ Operational Policies and Procedures 
+
+ AIIB Lending 
+
+ U.S. Policy Toward the AIIB 
+
+ Issues for Congress 
+
+ Oversight of the AIIB's Operations 
+
+ Potential U.S. Role 
+
+ Implications for MDB Governance 
+
+ Commercial Implications for U.S. Firms 
+
+ 
+ 
+ Figures
+
+ 
+ Figure 1. Annual Developing Country Infrastructure Needs (2015-2020) and Official Sector Financing (2013) 
+
+ Figure 2. Belt and Road and AIIB Countries/Projects 
+
+ Figure 3. AIIB Board of Directors 
+
+ 
+ 
+
+ 
+ Tables
+
+ 
+ Table 1. AIIB Member Countries 
+
+ Table 2. AIIB's Approved Projects as of January 2017 
+
+ 
+ 
+
+ 
+ 
+ Summary
+
+ In October 2013, at the Asia-Pacific Economic Cooperation Summit in Bali, Indonesia, China proposed creating a new multilateral development bank (MDB), the Asian Infrastructure Investment Bank (AIIB). As its name suggests, the Bank's stated purpose is to provide financing for infrastructure needs throughout Asia, as well as in neighboring regions. As of January 2017, the AIIB has approved nine projects, investing a total of $1.7 billion.
+
+ The AIIB was formally established in late 2015 with 57 founding members. Membership in the AIIB is open to all members of the World Bank or the Asian Development Bank (ADB). The AIIB's Articles of Agreement create two classes of membership: regional and non-regional members. According to the AIIB articles, regional members hold 75% of the total voting power in the Bank. Fourteen of the G-20 nations are AIIB members. The United States is not an AIIB member. 
+
+ The AIIB was initially conceived as a regional financing mechanism for Chinese President Xi Jinping's "One Belt, One Road (OBOR)" initiative. This initiative is a central component of President Xi's regional economic and foreign policy and aims to boost economic connectivity from China to Central and South Asia, the Middle East, and Europe (the Silk Road Economic Belt) and, along a maritime route, from Southeast Asia to the Middle East, Africa, and Europe (the 21 st Century Maritime Silk Road). President Xi, more so than previous Chinese leaders, has pursued policies to establish new China-led trade and financial institutions, as well as to further integrate China within the existing international financial institutions. President Xi said that the AIIB would "promote interconnectivity and economic integration in the region" and "cooperate with existing multilateral development banks," including the World Bank and the ADB.
+
+ As AIIB membership has expanded to include developed countries in Asia and Europe (and possibly Canada), China has since tried to distance the AIIB from the OBOR initiative through co-financing arrangements for its initial loans. It is uncertain how China will balance its stated goal of establishing an independent and high-standard MDB, while pursuing China's own economic and national security priorities.
+
+ The AIIB's initial total capital is $100 billion, with 20% paid-in and 80% callable. China is contributing $50 billion, half of the initial subscribed capital. India is the second-largest shareholder, contributing $8.4 billion. The Bank is based in Beijing, China, and headed by Jin Liqun, a former Chinese vice minister of finance, Chinese sovereign wealth fund chairman, and ADB vice president. 
+
+ China's voting share at the AIIB (28.7%) is substantially larger than that of the second-largest AIIB member nation, India (8.3%). This is the largest gap between the first- and second-largest shareholders at any existing MDB. The AIIB has a governance structure similar to other MDBs, with two key differences: (1) it does not have a resident board of executive directors that represents member countries' interests on a day-to-day basis; and (2) the AIIB gives more decisionmaking authority to regional countries and the largest shareholder, China.
+
+ The AIIB presents several policy issues for Members of Congress to consider, including 
+ the future direction of the AIIB and potential U.S. role, including the question of whether the United States should join and U.S. policy toward the new institution;
+
+ independence, transparency, and governance of the bank and implications for other MDBs, particularly projects that are co-financed with other MDBs; and
+
+ commercial implications for U.S. firms, including procurement opportunities.
+ 
+
+ 
+ 
+ Asian Infrastructure Investment Bank (AIIB)
+
+ 
+ Introduction
+
+ In October 2013, Chinese President Xi Jinping announced the establishment of a new China-led multilateral development bank, the Asian Infrastructure Investment Bank (AIIB), to "promote interconnectivity and economic integration in the region" and "cooperate with existing multilateral development banks," such as the World Bank and the Asian Development Bank (ADB). 1 After two years of negotiations, the AIIB was formally established on December 25, 2015. The Bank has 57 founding members, including four G-7 economies (France, Germany, Italy, and the United Kingdom), and began operations in mid-2016. According to AIIB officials, approximately 25 additional countries are expected to join in 2017. 2 
+
+ According to the AIIB's Articles of Agreement: 
+
+ The purpose of the Bank shall be to: (i) foster sustainable economic development, create wealth and improve infrastructure connectivity in Asia by investing in infrastructure and other productive sectors; and (ii) promote regional cooperation and partnership in addressing development challenges by working in close collaboration with other multilateral and bilateral development institutions. 3 
+
+ While there are large financing needs in the region, some observers question China's motives in establishing the AIIB, and argue that China is seeking to create an alternative to the World Bank and the ADB. As one non-Chinese individual involved in the AIIB negotiations told the Financial Times in June 2014, "China feels it can't get anything done in the World Bank or the International Monetary Fund so it wants to set up its own World Bank that it can control itself." 4 A broader concern for the United States is the emergence of Chinese-led regional economic institutions, such as the AIIB, in which the United States has little influence, as alternatives to the World Bank and o ther long-established multilateral bodes in which the United States has historically led. 5 
+
+ Others see the AIIB proposal and other Chinese economic statecraft efforts as direct Chinese challenges to U.S. monetary and economic leadership. 6 Instead of joining an MDB dominated by China and closely linked to China's foreign and economic policy goals, some analysts argue that the United States would be better served by supporting reforms at the World Bank and other MDBs to make the institutions more inclusive of developing country priorities and to make loans that are more attractive to borrower countries. These reforms could include shortening the time needed to approve loans, and reducing reporting requirements and loan conditionality. 
+
+ China's Motivation for Creating the AIIB
+
+ The creation of the AIIB is part of a broader reorientation of Chinese foreign and international economic policy that has taken place since Xi Jinping became Chinese Communist Party General Secretary in 2012 and president in 2013. 7 In contrast to his predecessor Hu Jintao, Xi has pursued an ambitious foreign policy agenda to deepen economic, security, and political ties with neighboring countries. Over the past several years, President Xi has spoken of building a "community of common destiny," first in the Asia-Pacific region and then throughout the globe. 8 His overarching goal, according to one observer, is to:
+
+ [L]everage China's economic power to build a network of new institutions, inspired by new ideas, to pursue new projects that will knit Eurasia, the South Pacific, and Eastern Africa into a tight network of economic, cultural, political, and strategic relationships. 9 
+
+ The centerpiece of Chinese foreign economic policy since 2013 is the "One Belt, One Road" (OBOR) initiative. 10 A report released by the China International Trade Institute in August 2015 identified 65 countries along the Belt and Road that will be participating in the Initiative, which aims to use trade promotion, infrastructure development, and regional connectivity, to boost economic linkages between China and dozens of countries along a land route (the Silk Road Economic Belt) and a sea route (the 21st Century Maritime Silk Road). 11 To realize this vision, China is investing in a range of institutions and initiatives, including the AIIB, and other funding mechanisms such as the Silk Road Fund and the New Development Bank (also known as the BRICS Bank), a collective arrangement with Brazil, Russia, India, and South Africa. 12 
+
+ China also seeks to influence the emerging structure of regional trade and investment relations. By helping to finance OBOR, AIIB may influence these relationships. It may also reinforce a regional infrastructure that has China as its hub. As a result, regional economies may be more inclined to augment trade and investment relations with China rather than with other economies, such as Japan, South Korea, Taiwan, and the United States. 
+
+ Reforming Global Economic Governance
+
+ While working to deepen its economic relationships with its neighbors through OBOR, China has also intensified its engagement with the "Bretton Woods Institutions"—the World Bank, the International Monetary Fund (IMF), and the regional development banks—with the aim of reforming the governance and operations of these institutions to accommodate China's increased economic influence in the global economy. 13 
+
+ For many years, Chinese leaders have argued that the international financial institutions have failed to recognize China's elevated stature in the global economy. 14 While recent reforms have boosted China's contributions and voting shares, China remains under-represented with respect to its weight in the global economy. 15 Since beginning market-oriented economic reforms in the late 1970s, China has averaged nearly 10% real GDP growth a year and is now the second-largest global economy in nominal terms behind the United States. 16 
+
+ Some observers, including Members of Congress, have linked China's creation of the AIIB directly to the long delay in U.S. approval of IMF governance reforms, which among other things, increased China's financial contributions and voting power in the IMF. 17 Despite approval by the IMF members in December 2010, Congress did not approve the reform package until 2015. While a full discussion of the reasons for the delay in IMF quota reform is outside the scope of this report, the delay contributed to a narrative that China was taking advantage of slow progress in reforming the main international financial institutions (IFIs) to build support for the AIIB. 
+
+ MDB and Chinese Financing of Infrastructure
+
+ Many countries face substantial infrastructure needs. Demand continues to grow as the pace of economic growth and development increases and more of the population in developing countries moves out of rural areas to urban centers. In 2015, World Bank economists estimated global and regional infrastructure investment requirements needed to satisfy consumer and producer demand in developing countries through 2020. 18 Their analysis found that developing countries would require annual investments of $819 billion in order to prevent a decrease in economic growth over the previous five-year period (2010-2015). South Asia and East Asia and the Pacific combined account for 63% ($516 billion) of the needed investment. 19 
+
+ In aggregate figures, the MDBs are among the largest providers of development support for infrastructure financing, although MDB financing for infrastructure has declined in recent decades (see text box ). According to data compiled by the Organization for Economic Cooperation and Development (OECD), total official support for infrastructure projects was $60 billion in 2013 and the World Bank was the largest provider, channeling $11.7 billion to infrastructure projects ( Figure 1 ).
+
+ China has also financed and built large-scale infrastructure projects, such as roads, dams, and water pipelines, throughout Asia, Africa, and Latin America, allegedly with little regard for social or environmental standards. 20 Chinse projects also disproportionately use Chinese construction companies and laborers. 21 This has led to criticism that Chinese assistance is undermining efforts by the United States and other countries to promote good governance and democracy in developing countries. Critics also charge that China's interest in providing development assistance and establishing the AIIB is self-serving, designed to enhance China's influence and access to raw materials, especially in Africa and Asia, at the expense of the United States. The AIIB, according to one observer, "can be seen as another prong in China's Monroe Doctrine, a signal that it should be free to call the shots in its own back yard." 22 
+
+ 
+ 
+ 
+ 
+ The Decline of Infrastructure Financing at the MDBs
+
+ MDB lending for infrastructure projects has declined over the past several decades. The World Bank was explicitly created to support infrastructure development as part of the economic reconstruction of Europe after World War II. Infrastructure was also the primary focus for the regional development banks when they were established in the 1950s and 1960s. By the early 1980s, however, MDBs had begun shifting their focus away from heavy infrastructure lending. Since then, the MDBs have largely embraced a view of economic development, shared by the United States and other developed economies, that places a greater emphasis on developing a robust investment climate (legal, political, economic ministries, for example) in developing countries rather than on funding basic infrastructure. 23 
+
+ At the same time, nongovernmental interest groups have pressured the MDBs to "to rationalize major infrastructure projects on social and environmental grounds." 24 The U.S. government considers policy conditionality, environmental and social safeguards, and measures such as rules on anti-corruption and best practices in procurement as being central to the effectiveness of development assistance, and has used its leadership in the MDBs to advance these priorities. Many MDB borrowers, however, view these conditions as restrictive. Setting aside the debate over the appropriate scope and content of MDB policy conditionality, the practical impact of these policies has been a shift, to a certain extent, away from financing infrastructure projects. Since the AIIB was proposed, however, the MDBs have reinvigorated their efforts to increase infrastructure financing in member countries. 25 
+
+ 
+ 
+ 
+ 
+
+ 
+
+ 
+
+ 
+ 
+ 
+ 
+ 
+ Figure 1. Annual Developing Country Infrastructure Needs (2015-2020) and Official Sector Financing (2013)
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: Data from IMF and the OECD, Graphic created by CRS.
+
+ 
+ 
+ 
+ 
+
+ As Figure 1 illustrates, the need for infrastructure financing far outweighs the amounts that are currently being provided by the MDBs and other official sources. Addressing Asia's large infrastructure gap will thus require mobilizing a variety of public and private sources of financing, as well as engaging with new sources of long-term development finance. Efforts include the creation in 2012 of an Association of Southeast Asian Nations (ASEAN) Infrastructure Fund (AIF), which began lending in 2013. In October 2014, the World Bank launched a Global Infrastructure Facility (GIF) to facilitate the preparation and structuring of complex infrastructure public-private partnerships (PPPs) to mobilize private sector infrastructure investments. 
+
+ AIIB Membership and Operations
+
+ Chinese President Xi Jinping first proposed the AIIB in October 2013, at the Asia-Pacific Economic Cooperation Summit in Bali, Indonesia. In October 2014, 21 regional countries met in China's capital, Beijing, and signed a Memorandum of Understanding (MOU) that set out the general principles for the new bank. China set the deadline for expressing interest in becoming a founding member of the AIIB for the end of March 2015. 
+
+ Initially, the United States government was opposed to the AIIB's creation and reportedly urged its allies and partners in Europe and in Asia not to join the AIIB, ostensibly because of concerns about the Bank's proposed policy guidelines and standards, and whether they would undermine existing MDB standards. 26 U.S. officials were caught off-guard when, in early 2015, the United Kingdom, followed by several other European countries, sought membership in the AIIB. 27 By the time the AIIB's Articles of Agreement were signed in December 2015, the Bank had 57 founding members, from every region except North America. 28 The Obama Administration later softened its criticism of the AIIB and would urge the other MDBs to work with the AIIB on the development of robust standards and practices. 
+
+ As AIIB membership grew to include European and other advanced economies, Chinese officials distanced the AIIB from China's OBOR initiative. During the early stages of the AIIB's creation, prior to the U.K.'s application, many OBOR documents explicitly referenced AIIB. In November 2014, shortly after China signed the MOU to begin negotiations, Chinese President Xi said that "China's inception and joint establishment of the AIIB with some countries is aimed at providing financial support for infrastructure development in countries along the 'One Belt, One Road' and promoting economic cooperation." 29 This view of the AIIB's role was reinforced by the spokesperson for the National People's Congress in March 2015: "AIIB and the Silk Road Fund are both created for the better implementation of 'One Belt, One Road.'" 30 
+
+ Beginning in mid-2015, Chinese officials created more distance between the rapidly expanding AIIB and China's OBOR strategy. In June 2016, during a meeting with global executives, AIIB President Jin Liqun clarified China's position, saying that while the Bank would support OBOR projects, the AIIB was not created exclusively for this initiative. Speaking in Washington, DC, alongside the World Bank's spring 2016 meetings, President Xi said "We would finance infrastructure projects in all emerging market economies even though they don't belong to the Belt and Road initiative." 31 
+
+ China has also differentiated AIIB projects from its other foreign assistance projects by co-financing its initial projects with the preexisting MDBs. 32 For example, according to a former director of economics at the National Security Council, c o-financing, comb ined with European membership, " will make it more likely this institution largely conforms to the international standards " and potentially will steer the AIIB away from becoming solely a tool of Chinese foreign policy. 33 It also supports China's stated intention to complement existing MDBs rather than compete with them. It also means the AIIB can depend on its partners for expertise on a wide range of policy and procedural issues as it develops its lending portfolio . 
+
+ Nonetheless, the AIIB's approved projects largely overlap with the geographic area of the OBOR initiative (see section below). Many initial projects are part of the China-Pakistan Economic Corridor, a central component of OBOR ( Figure 2 ). 34 It is uncertain how China will balance its stated goal of establishing an independent and high-standard MDB with pursuing its own economic and national security priorities for the region.
+
+ 
+ 
+ 
+ 
+ 
+ Figure 2. Belt and Road and AIIB Countries/Projects
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: AIIB. Graphic by CRS
+
+ 
+ 
+ 
+ 
+
+ Membership
+
+ Membership in the AIIB is open to all members of the World Bank or the ADB and is divided into regional and non-regional members. Regional members are those located within areas classified as Asia and Oceania by the United Nations. Unlike other MDBs, the AIIB allows for non-sovereign entities to apply for AIIB membership, assuming their home country is a member. Thus, sovereign wealth funds (such as the China Investment Corporation) or state-owned enterprises of member countries could potentially join the Bank. The AIIB has 57 founding members ( Table 1 ). 35 Over half of the members of the ADB have joined the AIIB and only two of the European ADB members have so far not joined (Belgium and Ireland). According to AIIB officials, approximately 25 additional countries are expected to join in 2017. 36 
+
+ 
+ 
+ Table 1. AIIB Member Countries
+
+ As of January, 2017
+
+ 
+
+ 
+ 
+ 
+ Region
+
+ 
+ 
+ Countries
+
+ 
+ 
+ 
+ 
+ Southeast Asia (10)
+
+ 
+ 
+ Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam
+
+ 
+ 
+ 
+ 
+ Northeast Asia (3)
+
+ 
+ 
+ China, Mongolia, South Korea
+
+ 
+ 
+ 
+ 
+ South Asia (6)
+
+ 
+ 
+ Bangladesh, India, Maldives, Nepal, Pakistan, Sri Lanka
+
+ 
+ 
+ 
+ 
+ Australasia (2)
+
+ 
+ 
+ Australia, New Zealand
+
+ 
+ 
+ 
+ 
+ Central Asia (5)
+
+ 
+ 
+ Azerbaijan, Kazakhstan, Kyrgyz Republic, Tajikistan, Uzbekistan 
+
+ 
+ 
+ 
+ 
+ Middle East (9)
+
+ 
+ 
+ Israel, Iran, Jordan, Kuwait, Oman, Qatar, Saudi Arabia, Turkey, United Arab Emirates
+
+ 
+ 
+ 
+ 
+ Africa (2)
+
+ 
+ 
+ Egypt, South Africa
+
+ 
+ 
+ 
+ 
+ Europe (19)
+
+ 
+ 
+ Austria, Denmark, Finland, France, Georgia, Germany, Iceland, Italy, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, the United Kingdom 
+
+ 
+ 
+ 
+ 
+ South America (1)
+
+ 
+ 
+ Brazil
+
+ 
+ 
+ 
+ 
+ Others (1)
+
+ 
+ 
+ Hong Kong
+
+ 
+ 
+ 
+ 
+ Source: AIIB website.
+
+ 
+
+ 
+
+ Japan has argued that until the AIIB has proven its adherence to international standards, any moves toward membership are premature. 37 In August 2016, Canada became the first North American country to apply for membership. 38 Canadian officials, like other advanced economies who joined the AIIB, argue that it is preferable to have a seat at the table during the establishment of the Bank and help ensure that the Bank adheres to international standards. 39 Its application is under consideration. 
+
+ Governance 
+
+ The AIIB has a governance structure similar to the other MDBs, with two key differences: the AIIB does not have a resident board of executive directors, and the AIIB's articles give a larger degree of decisionmaking authority to regional countries and the largest shareholder country, China. 40 
+
+ MDBs typically have a board of governors, a board of executive directors (executive board), a president, and several vice presidents. The board of governors is the highest decisionmaking body and typically comprises treasury secretaries or finance ministers of member countries. The AIIB's board of governors, which consists of senior government officials from each member nation, is responsible for making major decisions involving, for example, changes in AIIB membership, election of the president, and whether to increase the capital of the institution. 
+
+ Management of an MDB's day-to-day activities (approving loans, establishing policies, and overseeing MDB management) is typically delegated to a resident board of directors, which meets at least once a week. According to the articles, the AIIB's executive board comprises nine individuals elected by regional members and three elected by non-regional members. Each director has one or more alternate directors, depending on the number of countries in the constituency. 41 
+
+ The powers delegated to the AIIB's board of directors are substantially more modest when compared to other MDBs. They are limited to establishing AIIB policies; supervising AIIB management and operations; and approving strategic and planning documents and the AIIB budget. In contrast, the executive boards at the World Bank and other MDBs have substantially more authority, and must approve lending decisions. While all AIIB lending projects, to date, have been submitted to the AIIB's board of directors for approval, the board is expected to consider at some point a delegation of authority to the president to approve certain projects. 42 
+
+ The AIIB's Articles of Agreement include the number of shares allocated to each AIIB member based on a complex formula that takes into account the size of the economy and whether they are a regional or non-regional member. The articles also include provisions to determine how voting power is determined (based on a country's shareholding) that are strongly based on weighted voting. Voting shares of non-regional member countries are capped at 25%. 
+
+ China is the largest shareholder of the AIIB and maintains a 28% voting share. The disparity in voting shares between China and other member countries is striking. China's voting share at the AIIB (28%) is over 350% that of the second-largest AIIB member nation, India (8%). This is the largest gap between the first- and second-largest shareholders at any of the MDBs, although the United States has the largest voting share in any single other MDB (30% at the Inter-American Development Bank). The largest shareholders after India are Russia (6%), Australia (4%), and Turkey (3%). 43 
+
+ AIIB's Board of Directors
+
+ Figure 3 illustrates the composition of the AIIB executive board and the total share of votes of each constituency. Unless the AIIB's Articles of Agreement expressly provide otherwise, executive board votes are decided by a majority of votes cast. Given China's 28% voting share, a majority of votes could be achieved with as few as four members voting in favor. For special votes, such as approving membership, selecting the president, increasing the capital stock of the AIIB, and changing the size or composition of the executive board, the Articles of Agreement require a 75% special majority. 
+
+ As China will have more than a quarter of the votes, it will have an effective veto over these types of decisions. The United States has veto power over major governance decisions at the World Bank, the Inter-American Development Bank, and the IMF. 
+
+ 
+ 
+ 
+ 
+ 
+ Figure 3. AIIB Board of Directors
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: AIIB, CRS.
+
+ 
+ 
+ 
+ 
+
+ Since China proposed the AIIB and is its largest shareholder, it is not surprising that it is exerting political influence in the AIIB. One high-profile example is China's rejection of Taiwan's membership, despite its full membership in many other international organizations. The AIIB's articles state that any full ADB member can join the AIIB. Taiwan is a full ADB member under its preferred nomenclature "Taipei, China." China rejected Taiwan's application to be a founding member and has said that Taiwan can apply to be a regular member, but only if it asks China's Ministry of Finance to apply for membership on Taiwan's behalf, and if Taiwan uses an "appropriate name." 44 The assumption is that China will want Taiwan to enter as a sub-region of China. 
+
+ In April 2016, Taiwanese officials announced that it would not seek membership in the AIIB and "Taiwan would only apply for AIIB membership if we could do it with equality and dignity." 45 According to Rajiv Biswas, Asia Pacific chief economist of IHS Global Insight, "China's unilateral decision about Taiwan's membership indicates that China is essentially driving the decisionmaking, at least up to this stage, even though there are many other countries which have become founding members of the AIIB." 46 
+
+ Unlike in all the other MDBs, in the AIIB the board of directors will function on a non-resident basis, except as otherwise decided by the board of governors. The AIIB's non-resident board of directors, meeting once or twice a year, is substantially removed from the day-to-day activities of the institution and is unable to focus on anything but the most important strategic decisions. Critics of the current resident executive boards at the IMF, the World Bank, and the regional development banks have, however, long argued that resident boards are too expensive to maintain, costing between 3% and 7% of the institutions' operating budgets. 47 Proponents of resident boards argue they are essential for ensuring proper shareholder oversight, especially on matters of transparency and accountability. According to Robert Orr, a former U.S. executive director at the ADB: 
+
+ [T]he AIIB is not a corporation, rather an institution that represents nation-states. The shareholders in the new bank therefore represent taxpayers, whose interests must be guaranteed. Without a permanent board that has day-to-day oversight, the bank's ability to ensure these interests are greatly diminished. 48 
+
+ AIIB Presidency and Staff
+
+ At the AIIB's inaugural board of governors meeting in January 2016, Mr. Jin Liqun of China was elected AIIB president for a five-year term. Prior to his selection as president-designate in September 2015, Jin served as secretary-general of the AIIB's Multilateral Interim Secretariat (MIS), the entity tasked with preparing the legal, policy, and administrative frameworks and undertaking other preparatory work required for the establishment of AIIB. Mr. Jin worked previously as chairman of China's first joint-venture investment bank, China International Capital Corporation, Ltd (CICC); chairman of the Supervisory Board of China's sovereign wealth fund, the China Investment Corporation (CIC); vice president of the ADB; and vice minister of China's Ministry of Finance. 49 In addition to President Jin, the AIIB's senior management consists of five vice presidents and a general counsel, drawn from several AIIB member countries. 50 
+
+ Capital Structure
+
+ As a regional bank, the AIIB's regional members will hold the majority of the Bank's capital stock: a minimum of 75%, except as otherwise agreed by the board of governors. Other regional development banks, such as the African Development Bank and the Inter-American Development Bank, have similar arrangements. 
+
+ The initial subscribed capital of the AIIB is $100 billion. As of the end of 2016, $89 billion was subscribed. 51 Like other MDBs, the capital that shareholders contribute to the AIIB (as well as the other MDBs) comes in two forms: "paid-in capital," which generally requires the payment of cash to the MDB; and "callable capital," funds that shareholders agree to provide, but only when necessary to avoid a default on a borrowing or payment under a guarantee. Callable capital serves as ultimate backing for MDB borrowing in capital markets, though the MDBs have never called upon those resources. Callable capital cannot be used to finance loans, but only to pay off bondholders if the MDB is insolvent and unable to pay its bondholders.
+
+ At 20% of total capital, the AIIB will have a much higher share of paid-in capital than the World Bank and other MDBs. Out of $20 billion in initial authorized AIIB paid-in capital, $19.6 billion is already committed. 52 
+
+ The World Bank and the regional development banks began their operations with 20%-50% paid-in capital. This figure has fallen to around 5% for most of the MDBs, with the exception of the European Bank for Reconstruction and Development (EBRD). After the 2008 financial crisis, MDB member countries approved $350 billion in capital increases for the MDBs, but only agreed to pay in $15 billion, 4.2% of the total capital increase. 53 As a result of its large percentage of paid-in capital, the AIIB would be able to ramp up lending quickly. According to analysis prepared by the Overseas Development Institute, the AIIB could conservatively achieve a portfolio of around $120 billion by 2025. 54 An AIIB portfolio of $120 billion would be larger than any of other regional MDBs and almost as large as the World Bank's non-concessional lending window ($167.76 billion as of FY2016). 
+
+ Operational Policies and Procedures
+
+ Responding to concerns about the AIIB's governance, Chinese officials argue that the AIIB will be "lean, clean, and green":
+
+ AIIB's modus operandi is "lean, clean and green: lean with a small efficient management team and highly skilled staff; clean, an ethical organization with zero tolerance for corruption; and green, an institution built on respect for the environment." 55 
+
+ Whether the AIIB embraces strong environmental and social safeguards, and other policy-related conditions, remains a concern for many analysts, including Members of Congress, who played a major role in establishing robust safeguard policies at the MDBs and have used U.S. leadership at the institutions to advance best practices on these issues. These reforms have been instrumental in reducing the impact of MDB projects on local communities and limiting MBD funding for carbon-intensive energy projects, as well as stopping projects where corruption was apparent. At the same time, according to Yukon Huang, a former World Bank director for operations in Asia and Europe, many standards and procedures of existing MDBs are "frustratingly bureaucratic, costly and ill-suited to dealing with the real needs of client borrowers." 56 
+
+ Recent research finds that many developing countries increasingly avoid seeking MDB financing, especially for large infrastructure projects that trigger safeguards policies, a long-standing priority for the United States and other advanced economies at the MDBs. 57 
+
+ Overall, it is too early to assess the impact of the AIIB's performance standards, especially since the AIIB's co-financed projects are required to adhere to the partner agency's safeguards. However, since the AIIB is China's first foray into leading an MDB and China has many other vehicles to finance overseas infrastructure projects, many observers expect China to follow best practices at the AIIB. According to one Chinese analyst, "One thing is certain: the AIIB is determined to avoid reputational damage by making mistakes in its first projects." 58 To date, the AIIB has published several operational policies, including an Environmental and Social Framework (ESF) and policies on procurement and preventing corrupt practices, among others.
+
+ For example, the AIIB's Environmental and Social Framework (ESF) was approved in February 2016, with the possibility for updates after the first three years of AIIB operations. Environmental groups were invited to comment on a draft of the framework. According to the World Resources Institute, a global environmental research organization:
+
+ [T]he Framework's vision recognizes many of the issues such as climate change, gender, biodiversity and ecosystems, resettlement, labor practices and Indigenous Peoples that AIIB will encounter as it begins to make investments. It also makes very important commitments around transparency, information disclosure and public participation that exceed those of a number of national development banks, including key players such as the China Development Bank and the China Export-Import Bank. 59 
+
+ Other observers were more critical, pointing out concerns including 
+
+ [T]he reliance on corporate and country systems; lack of detail on the AIIB's oversight mechanism; the omission of coal from its exclusion list; its adoption of the phased approach, which allows plans for impacts on indigenous groups to be made after project approval; and the lack of mandatory environmental or social impact assessments for projects in Category B, defined as having limited environmental and social impacts. 60 
+
+ In October, 2016, the AIIB joined a statement by the heads of the IMF and the other MDBs affirming that their operations would be grounded in the latest international agreements on sustainable development (the 2015 Paris Agreement on Climate Change and the United Nations 2030 Agenda for Sustainable Development). 61 
+
+ AIIB Lending
+
+ According to the AIIB's articles, recipients of AIIB financing may include member countries (or agencies and entities or enterprises in member territories), as well as international or regional agencies concerned with the economic development of the Asia-Pacific region. 
+
+ The AIIB has signed a co-financing framework agreement with the World Bank and three non-binding Memoranda of Understanding with the ADB, EBRD, and the European Investment Bank (EIB). To date, the AIIB has approved nine projects worth $1.7 billion, most of which are being co-financed with established MDBs ( Table 2 ). No procurement information on these projects is currently available. It is unclear if information on which firms are winning projects and related procurement information will be made publically available. 
+
+ According to documents prepared for the Organization for Economic Cooperation and Development (OECD), AIIB officials foresee its lending program growing to $1.5-$2.5 billion in 2017 and $2.5-$3.5 billion in 2018. 62 Despite recent distancing from China's OBOR initiative by Chinese and AIIB leadership, many of the approved projects are closely aligned with the OBOR initiative. The project pipeline for the next two years includes projects in Azerbaijan, Georgia, India, Indonesia, and Oman, among others. 
+
+ Denmark and the United Kingdom requested that AIIB lending be included in the OECD's statistics on Official Development Assistance (ODA), a multilateral "stamp of approval" of the quality of the AIIB's activities. In March 2016, the Secretariat of the OECD's Development Advisory Committee reported that a review of the AIIB's mandate, activities, and budget supports the AIIB's inclusion in the ODA statistics. 63 To date, the OECD has not taken any decisions on the matter. 
+
+ 
+ 
+ Table 2. AIIB's Approved Projects as of January 2017
+
+ 
+
+ 
+ 
+ 
+ Project Name
+
+ 
+ 
+ Country
+
+ 
+ 
+ Sector
+
+ 
+ 
+ Partner
+
+ 
+ 
+ Project size
+
+ 
+ 
+ AIIB funding
+
+ 
+ 
+ 
+ 
+ Myingyan power plant
+
+ 
+ 
+ Myanmar
+
+ 
+ 
+ Energy
+
+ 
+ 
+ IFC/ADB
+
+ 
+ 
+ N/A
+
+ 
+ 
+ $20m
+
+ 
+ 
+ 
+ 
+ Tarbela 5 hydropower extension
+
+ 
+ 
+ Pakistan
+
+ 
+ 
+ Energy
+
+ 
+ 
+ World Bank
+
+ 
+ 
+ $824m
+
+ 
+ 
+ $300m
+
+ 
+ 
+ 
+ 
+ National motorway M-4
+
+ 
+ 
+ Pakistan
+
+ 
+ 
+ Transport
+
+ 
+ 
+ ADB/DFID
+
+ 
+ 
+ $273m
+
+ 
+ 
+ $100m
+
+ 
+ 
+ 
+ 
+ Distribution system upgrade
+
+ 
+ 
+ Bangladesh
+
+ 
+ 
+ Energy
+
+ 
+ 
+ None
+
+ 
+ 
+ $262m
+
+ 
+ 
+ $165m
+
+ 
+ 
+ 
+ 
+ Dushanbe-Uzbekistan border road
+
+ 
+ 
+ Tajikistan
+
+ 
+ 
+ Transport
+
+ 
+ 
+ EBRD
+
+ 
+ 
+ $106m
+
+ 
+ 
+ $28m
+
+ 
+ 
+ 
+ 
+ National slum upgrading
+
+ 
+ 
+ Indonesia
+
+ 
+ 
+ Urban infrastructure
+
+ 
+ 
+ World Bank
+
+ 
+ 
+ $1.7bn
+
+ 
+ 
+ $217m
+
+ 
+ 
+ 
+ 
+ Trans-Anatolian Natural Gas Pipeline
+
+ 
+ 
+ Azerbaijan
+
+ 
+ 
+ Energy
+
+ 
+ 
+ World Bank
+
+ 
+ 
+ $8.6bn
+
+ 
+ 
+ $600m
+
+ 
+ 
+ 
+ 
+ Duqm Port Commercial Terminal
+
+ 
+ 
+ Oman
+
+ 
+ 
+ Transport
+
+ 
+ 
+ None
+
+ 
+ 
+ $353m
+
+ 
+ 
+ $265m
+
+ 
+ 
+ 
+ 
+ Railway System Preparation
+
+ 
+ 
+ Oman
+
+ 
+ 
+ Transport
+
+ 
+ 
+ None
+
+ 
+ 
+ $36m
+
+ 
+ 
+ $60m
+
+ 
+ 
+ 
+ 
+ Source: AIIB.
+
+ 
+
+ 
+
+ U.S. Policy Toward the AIIB
+
+ Some observers have criticized the U.S. approach toward the AIIB during the Obama Administration. The criticism is well-captured by Evan Feigenbaum, a former State Department official in the George W. Bush Administration, who has written that, "The U.S. attempt to halt or marginalize the AIIB failed miserably." 64 Feigenbaum and others argue that the United States erred by resisting China's efforts and should have welcomed the institution when it was proposed or should join it now in order to help shape its policies and procedures. 65 In a bipartisan-chaired report making economic policy recommendations for the Trump Administration, the Center for Strategic & International Studies writes: 
+
+ [I]n recognition of Asians' desire for more ownership of regional economic architecture, the new administration should consider some form of U.S. participation in the AIIB. 66 
+
+ According to a November 2016 report from the Institute for the Analysis of Global Security,
+
+ Now that the bank is in operation and that it has taken encouraging steps to demonstrate its transparency and fidelity the United States should consider changing its approach toward it and take steps toward joining it. A U.S. accession of the AIIB would be an important gesture. Most important, it would signal to private sector players that it is safe to invest in projects co-financed by the AIIB. 67 
+
+ Others argue that the Obama Administration's focus on AIIB transparency and best practices was appropriate and provided constructive pressure on China. For example, China's efforts to integrate AIIB financing into the existing development system were praised by Treasury Secretary Jacob Lew at a March 2016 hearing before the House Appropriations Committee, where he took credit for pushing the Chinese to adopt high standards at the AIIB:
+
+ [O]ur position on the Asian Infrastructure bank has been, on the one hand, we think it's a good thing that there's more support for international infrastructure investment in Asia. But it's very important that it be done in a way that's consistent with standards, like the standards that we pursue in our multilateral development banks that we're involved in.
+
+We have made that case to all the participants; we've made that case to the Chinese. And I think we've had a lot of success. They have now adopted operating rules that are very much leaning towards observing the kinds of norms that we support in the multilateral institutions that we contribute to.
+
+ But now the question is what the actions will be. And we'll start to know when they make loans. The more they partner with the multilateral institutions that have high standards, the more likely they are to operate in a way that's consistent with the kinds of norms that are good for a growing, global economy and other values that we pursue in the multinational space. 68 
+
+ Turning to potential U.S. participation, the AIIB maintains that it is open to U.S. membership. 69 Some analysts argue that the U.S. government should reconsider its position and consider joining the AIIB. 70 David Dollar, a former World Bank economist and senior official in President Obama's Department of the Treasury, has emerged as one of the AIIB's main boosters in Washington, DC, and has argued that joining would be a "good investment" for the United States. 71 
+
+ Issues for Congress
+
+ The establishment of AIIB raises several political and economic issues for Congress as it examines the AIIB's activities and considers potential U.S. involvement with the Bank. 
+
+ Typically, Congress exercises its influence over MDB policy through its control over authorizations and appropriations, as well as through oversight. The authorizing committees have included in MDB authorizing legislation many directives which affect the goal and direction of U.S. policy. Congress has also used its control over the funding process—its "power of the purse"—to set priorities and encourage the Administration and MDBs to consider changes in their policies or procedures. 
+
+ Congress has used hearings and required reports to get information about U.S. policy and the MDBs into the public record and to draw the Treasury Department's attention to issues of pressing concern. Since the Administration knows it must come to Congress for future authorizations and MDB funding, the views expressed by Congress through hearings have often had an impact on the focus and direction of U.S. policy regarding particular concerns.
+
+ While the United States is not a member of the AIIB, and thus will not be authorizing and appropriating financial contributions, there are several avenues through which Congress can shape U.S. policy toward the institution. These include oversight of the AIIB's operations and shaping the evolving relationship between the AIIB and the MDBs where the United States is a member. 
+
+ Oversight of the AIIB's Operations 
+
+ Members of Congress may want to follow the AIIB's initial group of projects to gain a better understanding of whether and to what extent China is using the AIIB to finance its political and economic priorities in the region. Chinese officials see economic development in the region as helping to guard against regional instability (e.g., in Afghanistan, Pakistan, and Central Asia) and to deepen regional political and economic linkages to Beijing. 
+
+ Members may also consider looking at the potential impact of AIIB financing for regional infrastructure, interconnectivity, and trade relations. The potential strategic or security issues raised by greater economic linkages between China and developing countries in Central and South Asia may are also worth considering. For example, Members may consider how the AIIB may facilitate a reordering of Asian trade and investment relations toward China. 
+
+ Regional Chinese infrastructure financing may also serve to channel China's overcapacity in its manufacturing and construction sectors. Over the past decade, China has devoted around half of its GDP to domestic investment. If the current slowdown in the Chinese economy continues, regional infrastructure financing would be a way to redirect China's excess capacity in sectors such as rail and highways or port construction.
+
+ China's efforts on behalf of the AIIB also raise questions about China's relationship with the existing MDBs, where it remains a large borrower ($390 million of operations were approved in 2016). 72 Critics question why China still borrows large volumes from the MDBs, often for infrastructure projects, yet believes it has sufficient management expertise to lead a new MDB. Meanwhile, China continues to support its own large national development banks such as the China Development Bank and the Export-Import Bank of China. 
+
+ Potential U.S. Role
+
+ Members of Congress could consider possible ways to participate with the AIIB beyond the co-financing of projects between the AIIB and U.S.-led institutions such as the World Bank and the ADB. Members of Congress could recommend that the President pursue membership in the institution or direct the Treasury Department to report on the feasibility and costs and benefits of U.S. membership in the institution. Members could consider ways to influence the AIIB's activities outside of joining, such as encouraging further co-financing arrangements and/or participating as an observer.
+
+ Another option to facilitate U.S. cooperation with the AIIB would be to extend diplomatic privileges and immunities to AIIB personnel. As international organizations have become increasingly important for multilateral relations and cooperation, representatives to and employees of such organizations have occasionally been granted privileges and immunities similar to those traditionally accorded to diplomats or consular officials. The International Organizations Immunities Act (IOIA) provides a significant number of privileges and immunities for international organizations designated by the President (this includes personnel of the United Nations, IMF, World Bank, and several dozen other international organizations; the United States is not a member of some of these organizations). 73 For example, the United States is not a member of the African Union. 74 In 2007, President Bush extended diplomatic immunities and privileges to the African Union Mission to the United States. 75 
+
+ Others argue that U.S. officials should focus their efforts on increasing the attractiveness of the World Bank and the other MDBs where the United States is a dominant member, by advocating for and approving greater representation by developing countries in the institutions and embracing innovative financing mechanisms, such as the World Bank's Program-for-Results, which seeks to promote greater reliance on domestic regulatory regimes while linking finance to performance and development outcomes. 76 
+
+ Members might also want to consider a broader review of the MDB system in light of the proliferation of sources of development finance. Compared to 15 or 20 years ago, when the MDBs and other traditional donors provided the bulk of development assistance, the current environment is characterized as an "age of choice," with a variety of new donors, multilateral funds, private investment funds, etc. 77 In light of the new landscape for development finance, Members may consider whether MDBs are still a preferred means for providing official development assistance. Members may also want to consider the extent to which there may be duplication of efforts across the MDBs, and the role of private financing.
+
+ Implications for MDB Governance
+
+ Several operational aspects of the proposed AIIB raise concerns for some U.S. officials. China's large voting power combined with the AIIB's non-resident executive board has led some analysts to question the AIIB's independence from Chinese leaders. The exact nature of the relationship between the AIIB and China's domestic foreign and economic policy agenda remains unclear.
+
+ Prior to the establishment of the AIIB, China, through its bilateral aid, has supported large-scale infrastructure projects throughout Asia often with less regard to social or environmental standards, or the underlying institutions in the recipient country. Some observers are concerned that some developing countries will resist the safeguards and conditions attached to World Bank or ADB loans and turn to the AIIB instead. 78 Other analysts stress that the AIIB's safeguards policies and operating procedures are largely drawn from the policies of the other MDBs, and have been largely well received by the official and NGO community. Since most of the AIIB's initial projects are co-financed with more established MDBs and must follow their safeguards and standards, it is still too early to evaluate the AIIB's compliance with its own stated policies. 
+
+ Commercial Implications for U.S. Firms
+
+ Members might want to consider the implications for U.S. firms if the AIIB facilitates the emergence of China-focused regional standards or norms. For example, if China uses the AIIB to install network and telecommunications equipment made by the Chinese companies Huawei and ZTE throughout the Asia-Pacific region, U.S. technology firms might be effectively kept out of the Asia-Pacific market.
+
+ Members of Congress may also want to follow the procurement contracting for the AIIB's initial projects. While China has issued assurances that there will be open and transparent procurement, and the AIIB has issued procurement policies and guidelines in January and July 2016, it remains uncertain to what extent firms from non-AIIB member countries will be considered and/or chosen for bidding on AIIB projects. 79 Will U.S. firms be able to bid fairly and participate in projects funded by the AIIB? As with MDB governance policies, it remains too early to evaluate the AIIB's commitment to open and transparent procurement. 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+ Author Contact Information
+ 
+ [author name scrubbed], Specialist in International Trade and Finance
+ ( [email address scrubbed] , [phone number scrubbed])
+ 
+
+ 
+
+ 
+
+ 
+ Footnotes
+
+ 
+ 
+ 1 .
+ 
+ 
+ "President Xi Jinping Holds Talks with President Susilo Bambang Yudhoyono of Indonesia," Ministry of Foreign Affairs of the People's Republic of China, October 2, 2013. 
+
+ 
+ 
+ 
+ 2 .
+ 
+ 
+ James Kynge and David Pilling, "China-Led Investment Bank Attracts 25 New Members," Financial Times , January 24, 2017.
+
+ 
+ 
+ 
+ 3 .
+ 
+ 
+ Articles of Agreement, Asian Infrastructure Investment Bank. 
+
+ 
+ 
+ 
+ 4 .
+ 
+ 
+ Jamil Anderlini, "China Expands Plans for World Bank Rivals," Financial Times , June 24, 2014.
+
+ 
+ 
+ 
+ 5 .
+ 
+ 
+ For example, China is actively involved in negotiations on a Regional Comprehensive Economic Partnership (RCEP) among the ten members of the Association of Southeast Asian Nations (ASEAN) and their trade agreements partners. For more information, visit https://aric.adb.org/fta/regional-comprehensive-economic-partnership . 
+
+ 
+ 
+ 
+ 6 .
+ 
+ 
+ Sabrina Snell, China's Development Finance: Outbound, Inbound, and Future Trends in Financial Statecraft , U.S.-China Economic, and Security Review Commission, Washington, D.C., December 16, 2015.
+
+ 
+ 
+ 
+ 7 .
+ 
+ 
+ For more information, see CRS In Focus IF10029, China, U.S. Leadership, and Geopolitical Challenges in Asia , by [author name scrubbed]. 
+
+ 
+ 
+ 
+ 8 .
+ 
+ 
+ Jin Kai, "Can China Build a Community of Common Destiny?" The Diplomat , November 28, 2013. 
+
+ 
+ 
+ 
+ 9 .
+ 
+ 
+ William A Callahan, "China's "Asia Dream"; The Belt and Road Initiative and the new regional order," Asian Journal of Comparative Politics , vol. 1, no. 3 (2016), pp. 226-243.
+
+ 
+ 
+ 
+ 10 .
+ 
+ 
+ CRS In Focus IF10273, China's "One Belt, One Road" , by [author name scrubbed] and [author name scrubbed].
+
+ 
+ 
+ 
+ 11 .
+ 
+ 
+ Vision and Actions on Jointly Building Silk Road Economic Belt and 21st Century Maritime Silk Road, the National Development and Reform Commission, Ministry of Foreign Affairs, and Ministry of Commerce of the People's Republic of China, March 2015.
+
+ 
+ 
+ 
+ 12 .
+ 
+ 
+ Kevin P. Gallagher, Rohini Kamal, Yongzhong Wang and Yanning Chen, "Fueling Growth and Financing Risk," Boston University Global Economic Governance Initiative , Working Paper 002, May 2016. See also, Kevin P. Gallagher and Amos Irwin, "Exporting National Champions: China's OFDI Finance in Comparative Perspective," China and the World Economy , Vol. 22., Is. 6. 2014. See also, Deborah Brautigam, Testimony on China's Growing Role in Africa before the United States Senate Committee on Foreign Relations Subcommittee on African Affairs, November 1, 2011. 
+
+ 
+ 
+ 
+ 13 .
+ 
+ 
+ Honying Yang, From "Taoguang Yanghui" to "Yousuo Zuowei": China's Engagement in Financial Minilateralism , Center for Global Governance Innovation, CIGI Working Paper No. 52, Waterloo, Canada, December 12, 2014. See also, Hai Yang, "The Asian Infrastructure Investment Bank and Status-Seeking: China's Foray into Global Economic Governance," China Political Science Review , October 20, 2016. 
+
+ 
+ 
+ 
+ 14 .
+ 
+ 
+ "China's calls for reform at the World Bank, IMF and ADB cannot be ignored any longer," South China Morning Post , September 12, 2016.
+
+ 
+ 
+ 
+ 15 .
+ 
+ 
+ Alex He, The Dragon's Footprints: China in the Global Economic Governance System (McGill-Queens University Press, 2016).
+
+ 
+ 
+ 
+ 16 .
+ 
+ 
+ CRS Report RL33534, China's Economic Rise: History, Trends, Challenges, and Implications for the United States , by [author name scrubbed].
+
+ 
+ 
+ 
+ 17 .
+ 
+ 
+ CRS In Focus IF10134, IMF Quota and Governance Reforms , by [author name scrubbed] and [author name scrubbed].
+
+ 
+ 
+ 
+ 18 .
+ 
+ 
+ Fernanada Ruiz-Nunez and Zichao Wei, Infrastructure Investment Demands in Emerging Markets and Developing Economies , World Bank, Policy Research Working Paper 7414, Washington, DC, September 2015.
+
+ 
+ 
+ 
+ 19 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 20 .
+ 
+ 
+ Kevin P. Gallagher, Rohini Kamal, Yongzhong Wang and Yanning Chen, "Fueling Growth and Financing Risk," Boston University Global Economic Governance Initiative , Working Paper 002, May 2016.
+
+ 
+ 
+ 
+ 21 .
+ 
+ 
+ Clifford Krauss and Keith Bradsher, "China's Global Ambitions, Cash and Strings Attached," The New York Times , July 24, 2015.
+
+ 
+ 
+ 
+ 22 .
+ 
+ 
+ Yoichi Funabashi, "A Futile Boycott of China's Bank Will Not Push Xi Out of His Back Yard," Financial Times , December 9, 2014.
+
+ 
+ 
+ 
+ 23 .
+ 
+ 
+ Christopher Humphrey, Infrastructure Finance in the Developing World: Challenges and Opportunities for Multilateral Development Banks in 21st Century Infrastructure Finance , Intergovernmental Group of Twenty Four/Global Green Growth Institute, Seoul, Korea, June 2015.
+
+ 
+ 
+ 
+ 24 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 25 .
+ 
+ 
+ For example, see G20 Development Working Group and G20 Investment and Infrastructure Working Group, Partnering to Build a Better World: MDB's Common Approach to Supporting Infrastructure Development , September 18, 2015.
+
+ 
+ 
+ 
+ 26 .
+ 
+ 
+ Jamil Anderlini, "Big Nations Snub Beijing Bank Launch after US Lobbying," Financial Times , October 23, 2014.
+
+ 
+ 
+ 
+ 27 .
+ 
+ 
+ Nicholas Watt, Paul Lewis, and Tania Branigan, "US anger at Britain joining Chinese-led investment bank AIIB," The Guardian , March 13, 2015.
+
+ 
+ 
+ 
+ 28 .
+ 
+ 
+ Canada, however, applied for AIIB member in August 2016.
+
+ 
+ 
+ 
+ 29 .
+ 
+ 
+ Quoted in Yun Sun, "China and the Evolving Asian Infrastructure Investment Bank," in Daniel Bob, ed. Asian Infrastructure Investment Bank : China as Responsible Stakeholder, Sasakawa USA, 2015 . 
+
+ 
+ 
+ 
+ 30 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 31 .
+ 
+ 
+ Zhong Nan and Cai Xiao, "AIIB Leas support for Belt and Road Infrastructure Projects," China Daily , June 8, 2016.
+
+ 
+ 
+ 
+ 32 .
+ 
+ 
+ Ibid. 
+
+ 
+ 
+ 
+ 33 .
+ 
+ 
+ Matthew Goodman, quoted in Ian Talley, "U.S. Looks to Work with China-Let Infrastructure Fund," The Wall Street Journal , March 22, 2015.
+
+ 
+ 
+ 
+ 34 .
+ 
+ 
+ A listing of these projects can be found at http://euweb.aiib.org/html/2016/PROJECTS_1010/163.html .
+
+ 
+ 
+ 
+ 35 .
+ 
+ 
+ Of the 57 founding members, all but eight countries have ratified the AIIB's Articles of Agreement: Brazil, Iran, Kuwait, the Philippines, Portugal, Spain, South Africa and Uzbekistan. The ratification status of prospective AIIB founding members are available at http://euweb.aiib.org/html/aboutus/introduction/Membership/?show=0 .
+
+ 
+ 
+ 
+ 36 .
+ 
+ 
+ James Kynge and David Pilling, "China-Led Investment Bank Attracts 25 New Members," Financial Times , January 24, 2017.
+
+ 
+ 
+ 
+ 37 .
+ 
+ 
+ Kazuyuki Suwa, Japan's AIIB Quandary , The Tokyo Foundation, August 3, 2015.
+
+ 
+ 
+ 
+ 38 .
+ 
+ 
+ Pei Li, "Canada Applies to Join AIIB," The Wall Street Journal , August 31, 2016.
+
+ 
+ 
+ 
+ 39 .
+ 
+ 
+ Jane Perlez, "Canada to Join China-Led Bank, Signaling Readiness to Bolster Ties," The New York Times , August 31, 2016.
+
+ 
+ 
+ 
+ 40 .
+ 
+ 
+ Mike Gallagher and Paul Hubbard, "The Asian Infrastructure Investment Bank: Multilateralism on the Silk Road," China Economic Journal , vol. 9, no. 2 (2016).
+
+ 
+ 
+ 
+ 41 .
+ 
+ 
+ The nations currently represented on the AIIB Board of Directors are; Australia, China, Egypt, Germany, India, Indonesia, Saudi Arabia, South Korea, Russia, Thailand, Turkey, and the United Kingdom.
+
+ 
+ 
+ 
+ 42 .
+ 
+ 
+ AIIB Operational Policy on Financing, January 2016. 
+
+ 
+ 
+ 
+ 43 .
+ 
+ 
+ AIIB Membership, shareholding and voting power is available at http://euweb.aiib.org/html/aboutus/governance/MoB/?show=1 .
+
+ 
+ 
+ 
+ 44 .
+ 
+ 
+ Cheng Ting-Fang, "Taiwan rejects joining AIIB under China's supervision," Nikkei Asian Review , April 13, 2016.
+
+ 
+ 
+ 
+ 45 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 46 .
+ 
+ 
+ Kit Tang, "China says no to Taiwan on AIIB: What it means," CNBC , April 14, 2015.
+
+ 
+ 
+ 
+ 47 .
+ 
+ 
+ Leonardo Martinez-Diaz, "Executive Boards in International Organizations: Lessons for Strengthening IMF Governance," International Monetary Fund, Independent Evaluation Office , Background Paper 08, May 2008. 
+
+ 
+ 
+ 
+ 48 .
+ 
+ 
+ Robert M. Orr, Why the Asian Infrastructure Investment Bank needs resident directors , Chinadialogue, August 23, 2016.
+
+ 
+ 
+ 
+ 49 .
+ 
+ 
+ "AIIB President Mr. Jin Liqun," Asian Infrastructure Investment Bank website, http://euweb.aiib.org/html/aboutus/governance/president/ .
+
+ 
+ 
+ 
+ 50 .
+ 
+ 
+ "AIIB Vice Presidents and General Counsel," Asian Infrastructure Investment Bank website, http://euweb.aiib.org/html/aboutus/governance/Senior_Management/Vice_Presidents/?show=1 .
+
+ 
+ 
+ 
+ 51 .
+ 
+ 
+ Several countries are in the process of completing the AIIB's membership process: Iran, Kuwait, Malaysia and Philippines (Regional); and Brazil, Portugal, South Africa and Spain (non-Regional). A table showing the Membership status of Founding Signatories to the Bank's Articles is available at http://euweb.aiib.org/html/aboutus/governance/Membership/?show=1 .
+
+ 
+ 
+ 
+ 52 .
+ 
+ 
+ Chris Humphrey, "Will the Asian Infrastructure Investment Bank's Development Effectiveness Be a Victim of China's Diplomatic Success?" in "Multilateral Development Banks in the 21 st century: Three Perspectives on the China and the Asian Infrastructure Investment Bank," Overseas Development Institute , November 2015. 
+
+ 
+ 
+ 
+ 53 .
+ 
+ 
+ CRS Report R41672, Multilateral Development Banks: General Capital Increases , by [author name scrubbed].
+
+ 
+ 
+ 
+ 54 .
+ 
+ 
+ Ibid. Assumptions include: return on equity of 3.5% per year, equity/loans ratio of 20%, no returns on lending for first two years and paid-in capital of $19.6 paid in over five years. Depending on how the AIIB manages its finances, this figure could grow even higher. 
+
+ 
+ 
+ 
+ 55 .
+ 
+ 
+ AIIB website.
+
+ 
+ 
+ 
+ 56 .
+ 
+ 
+ Yukon Huang, "China has a role to play in setting the 'right' standards," Financial Times , April 8, 2015.
+
+ 
+ 
+ 
+ 57 .
+ 
+ 
+ Christopher Humphrey, "Time for a new approach to environmental and social protection at multilateral development banks," Overseas Development Institute , April 2016. 
+
+ 
+ 
+ 
+ 58 .
+ 
+ 
+ Liu Qin, "China-led development bank careful to co-operate with critics," Thethirdpole.net , August 5, 2016. 
+
+ 
+ 
+ 
+ 59 .
+ 
+ 
+ Gaia Larson and Sean Gilbert, Asian Infrastructure Investment Bank Releases New Environmental and Social Standards. How Do They Stack Up?" World Resources Institute , March 4, 2016. 
+
+ 
+ 
+ 
+ 60 .
+ 
+ 
+ Rohini Kamal and Kevin Gallagher, "China Goes Global with Development Banks," Bretton Woods Project , April 5, 2016.
+
+ 
+ 
+ 
+ 61 .
+ 
+ 
+ Delivering on the 2030 Agenda , October 9, 2016. 
+
+ 
+ 
+ 
+ 62 .
+ 
+ 
+ OECD DAC Working Party on Development Finance Statistics, Proposals for changes to Annex 2 of the Converged Statistical Reporting Directives for the Creditor Reporting System (CRS) and the Annual DAC Questionnaire , March 16, 2016. 
+
+ 
+ 
+ 
+ 63 .
+ 
+ 
+ Ibid.
+
+ 
+ 
+ 
+ 64 .
+ 
+ 
+ Evan Feigenbaum, "China and the World," Foreign Affairs , January/February 2017.
+
+ 
+ 
+ 
+ 65 .
+ 
+ 
+ James Woolsey Jnr., "Under Donald Trump, the US will accept China's rise – as long as it doesn't challenge the status quo," South China Morning Post , November 10, 2016.
+
+ Jim Zarolli, "New Asian Development Bank Seen As Sign Of China's Growing Influence," National Public Radio, April 16, 2015. 
+
+ 
+ 
+ 
+ 66 .
+ 
+ 
+ Charlene Barshefsky, Evan G. Greenberg, and Jon Huntsman Jr., Reinvigorating U.S. Economic Strategy in the Asia Pacific , Center for Strategic & International Studies, Washington, DC, January 2017.
+
+ 
+ 
+ 
+ 67 .
+ 
+ 
+ Gal Luft, China's One Belt One Road Initiative: An American Response to the New Silk Road, Institute for the Analysis of Global Security , November 2016. 
+
+ 
+ 
+ 
+ 68 .
+ 
+ 
+ House Committee on Appropriations, Subcommittee on State, Foreign Operations, and Related Programs, Budget Hearing - Department of Treasury International Programs, March 15, 2016.
+
+ 
+ 
+ 
+ 69 .
+ 
+ 
+ "AIIB's Jin Says Bank's Door Still Open to Trump After Obama Snub," Bloomberg , January 8, 2017.
+
+ 
+ 
+ 
+ 70 .
+ 
+ 
+ "China on the World Stage: A bridge not far enough," The Economist , March 21, 2015. 
+
+ 
+ 
+ 
+ 71 .
+ 
+ 
+ Chen Weihua, "AIIB is 'good investment for US'" China Daily USA , October 20, 2016. 
+
+ 
+ 
+ 
+ 72 .
+ 
+ 
+ Data on China's lending from the World Bank is available at http://data.worldbank.org/country/china .
+
+ 
+ 
+ 
+ 73 .
+ 
+ 
+ International Organizations Immunities Act, 22 U.S.C. § 288 et seq. For more information, see Aaron I Young, "Deconstructing International Organization Immunity," Georgetown Journal of International Law , vol. 44, 2012. 
+
+ 
+ 
+ 
+ 74 .
+ 
+ 
+ CRS Report R44713, The African Union (AU): Key Issues and U.S.-AU Relations , by [author name scrubbed] and [author name scrubbed]. 
+
+ 
+ 
+ 
+ 75 .
+ 
+ 
+ Exec. Ord. No. 13444, September 12, 2007, 72 Fed. Reg. 52747.
+
+ 
+ 
+ 
+ 76 .
+ 
+ 
+ Scott Morris, "Responding to AIIB," Council on Foreign Relations , September 2016. 
+
+ 
+ 
+ 
+ 77 .
+ 
+ 
+ Romily Greenhill, Annalisa Prizzon, and Andrew Rogerson, "The age of choice: developing countries in the new aid landscape," Overseas Development Institute , January 2013. 
+
+ 
+ 
+ 
+ 78 .
+ 
+ 
+ Paola Subacchi, "The AIIB Is a Threat to Global Economic Governance," Foreign Policy , March 31, 2015.
+
+ 
+ 
+ 
+ 79 .
+ 
+ 
+ The AIIB's Procurement Policy is available at http://www.aiib.org/uploadfile/2016/0226/20160226051326635.pdf . For more information, see Jedrzej Gorski, An Update on AIIB's Procurement Regulations, Procurement Policy and Co-operation with Other Multilateral Development Banks , Centre for Financial Regulation and Economic Development, The Chinese University of Hong Kong, Working Paper No. 17, May 2016.
\ No newline at end of file
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+++ b/corpus/politics/text/d68208f5069e066e.txt
@@ -0,0 +1,3809 @@
+State, Foreign Operations, and Related 
+Programs: FY2014 Budget and Appropriations 
+
+ Susan B. Epstein 
+ Specialist in Foreign Policy 
+
+ Alex Tiersky 
+ Analyst in Foreign Affairs 
+
+ Marian L. Lawson 
+ Specialist in Foreign Assistance Policy 
+
+January 16, 2014 
+
+ Congressional Research Service 
+
+7-5700 
+
+www.crs.gov 
+
+R43043 
+
+ 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Summary 
+
+On April 10, 2013, the Obama Administration submitted to Congress its budget request for 
+FY2014. The request for State, Foreign Operations, and Related Programs totals $51.84 billion, 
+which is about 0.8% below the FY2013 post-sequester estimated funding level of $52.24 billion. 
+Within this total, $3.81 billion is designated as Overseas Contingency Operations (OCO) funding, 
+which is 68% below FY2013 estimated OCO funding of $11.91 billion. Of the total request, 
+$16.88 billion is for State Department Operations and related agencies, a 4.5% decline from the 
+FY2013 funding estimate. About $35.1 billion is for Foreign Operations, a 1.6% increase from 
+the FY2013 estimate. After enacting appropriations for FY2014 with continuing resolutions in 
+late 2013-early 2014, Congress was completing action on a consolidated appropriations bill (H.R. 
+3547) in mid-January 2014. 
+
+This report provides a brief overview of the FY2014 State Department, Foreign Operations and 
+Related Programs funding request, as well as top-line analysis of House and Senate State-Foreign 
+Operations appropriations proposals and enacted continuing resolutions. It does not provide 
+information or analysis on specific provisions in the House and Senate legislation. A full update 
+of the report will be completed after final action on FY2014 appropriations. 
+
+A table in the Appendix provides side-by-side account-level funding data for FY2013, the 
+FY2014 request, and pending FY2014 proposals, including the Consolidated Appropriations Act 
+(H.R. 3547). The FY2013 funding data used as a point of comparison throughout this report 
+represent post-sequestration estimates provided by the Department of State and reflect across-the-
+board rescissions. These data are not yet available for all accounts, or for country allocations. The 
+funding table in the Appendix will be updated as more information becomes available. 
+
+ 
+
+Congressional Research Service 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Contents 
+
+Continuing Appropriations Act, 2014 .............................................................................................. 1 
+Government Shutdown Effects on the Department of State and Foreign Aid ................................. 1 
+FY2014 State-Foreign Operations Overview .................................................................................. 3 
+FY2014 State Operations Request Overview .................................................................................. 5 
+State Operations Key Issues ............................................................................................................ 6 
+
+Diplomatic Security ................................................................................................................... 6 
+Management and Human Resources of the Department of State .............................................. 7 
+Expeditionary Diplomacy and Key Regional Initiatives ........................................................... 7 
+
+FY2014 Foreign Operations Request Overview .............................................................................. 8 
+Foreign Operations Key Issues ...................................................................................................... 10 
+
+Support for Middle East and North Africa Transitions ............................................................ 10 
+Overseas Contingency Operations........................................................................................... 11 
+Food Aid Reform ..................................................................................................................... 12 
+Humanitarian Assistance ......................................................................................................... 13 
+Ongoing Administration Initiatives ......................................................................................... 14 
+
+ 
+
+ Figures 
+
+Figure 1. State & Foreign Operations Appropriations, FY2012, FY2013, FY2014 Request 
+
+and the FY2014 House and Senate Proposals .............................................................................. 4 
+
+ 
+
+ Tables 
+
+Table 1. Status of State-Foreign Operations Appropriations, FY2014 ............................................ 4 
+Table 2. State Department & Related Programs: Total Funding and Select Accounts .................... 5 
+Table 3. Foreign Aid by Appropriations Title, FY2012 Actual and FY2014 Request ..................... 9 
+Table 4. Top 10 Recipients of U.S. Foreign Assistance, FY2012 Actual 
+
+and FY2014 Request .................................................................................................................. 10 
+
+Table 5. Overseas Contingency Operations Funding in Foreign Operations Accounts, 
+
+FY2012, FY2013 Request, and FY2014 Request....................................................................... 12 
+
+Table A-1. State Department, Foreign Operations and Related Agencies Appropriations, 
+
+FY2013-FY2014 ......................................................................................................................... 15 
+
+ 
+
+ Appendixes 
+
+Appendix. State-Foreign Operations Appropriations, by Account ................................................ 15 
+
+ 
+
+Congressional Research Service 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Contacts 
+
+Author Contact Information........................................................................................................... 22 
+
+ 
+
+Congressional Research Service 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Continuing Appropriations Act, 2014 
+
+After 16 days of a government shutdown resulting from an appropriations lapse, Congress passed 
+the Continuing Appropriations Act, 2014 (H.R. 2775), on October 16, 2013; the President signed 
+it into law (P.L. 113-46) on October 17, 2013. The continuing resolution (CR) continues FY2013 
+funding levels, including previous sequestration and rescission reductions, until January 15, 2014. 
+H.J.Res. 106, approved by the House and Senate on January 15, extended the CR through January 
+18, allowing extra time for legislative consideration of H.R. 3547, the Consolidated 
+Appropriations Act, 2014. Table A-1 in the Appendix has been updated to show account funding 
+in H.R. 3547. A full update of the report will be completed after final action on FY2014 
+appropriations. 
+
+ The Budget Control Act and State-Foreign Operations Appropriations 
+
+Sequestration required by the Budget Control Act of 2011 (BCA, P.L. 112-25, amended by the American Taxpayer 
+
+Relief Act of 2012, P.L. 112-240), together with an additional 0.032% across-the-board rescission resulting from 
+Section 3004 of the Consolidated and Further Continuing Appropriations Act, 2013 (P.L. 113-6), reduced FY2013 
+Department of State and Foreign Operations discretionary funding by an estimated 2% from the enacted level. As 
+determined by the BCA, for some Department of State, U.S. Agency for International Development (USAID), and 
+foreign aid activities, sequestration and rescissions are applied at the account level, such as USAID Operating 
+Expenses. For others, such as Development Assistance (DA), Foreign Military Financing (FMF), Economic Support 
+Fund (ESF), and Global Health Programs (GHP), reductions are at the country allocation level. Overseas Contingency 
+Operations (OCO) funds are subject to sequester, but do not count toward spending caps. This report uses FY2013 
+post-sequester funding estimates when available. 
+
+The sequestration process could again be triggered after January 15, FY2014, if Congress does not either enact 
+appropriations legislation that is consistent with budget caps or repeal or amend the BCA. On December 12 and 18, 
+2013, respectively, the House and Senate agreed to the Bipartisan Budget Act (BBA, H.J.Res. 59), which established 
+less stringent spending caps for FY2014 and FY2015 than the BCA, potential y easing the way for an appropriations 
+agreement. However, the BBA did not repeal the BCA sequestration process. Congress still must pass FY2014 
+appropriations within the revised statutory limits to avoid sequestration. For more detail, see CRS Report R42994, 
+ The Budget Control Act, Sequestration, and the Foreign Affairs Budget: Background and Possible Impacts , by Susan B. Epstein. 
+
+ Government Shutdown Effects on the Department 
+of State and Foreign Aid 
+
+FY2014 began on October 1, 2013, with a partial government shutdown because Congress had 
+not passed any appropriations bills for FY2014 and could not agree to differing House and Senate 
+terms for a continuing resolution (CR) to keep the government funded.1 State operations and 
+foreign assistance programs generally continued to operate because of two-year funding for the 
+Department of State’s Diplomatic and Consular Programs account that funds salaries and 
+expenses and the U.S. Agency for International Development’s (USAID) Operating Expenses 
+account. In addition to residual FY2013 and prior year money, trust funds, fees, permanent 
+
+ 
+
+1 For general information about government shutdowns, see CRS Report RL34680, Shutdown of the Federal 
+Government: Causes, Processes, and Effects , coordinated by Clinton T. Brass. 
+
+Congressional Research Service 
+
+1 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+appropriations, and the Working Capital Fund remained available.2 In contrast, the Office of 
+Inspector General, the International Boundary and Water Commission, and reportedly the 
+American Sections of the International Joint Commission and International Boundary 
+Commission operate on single-year appropriations and did shut down until the CR became law. 
+
+Since the majority of foreign aid programs operate with multi-year or no-year funding, most 
+foreign aid continued to flow. Activities within these programs, however, were limited by 
+prohibitions on new grants and cooperative agreements as well as restrictions on travel, training, 
+and representational events, among other things. These applied to programs such as State’s global 
+health activities, migration and refugee assistance, and democracy promotion funds. 
+
+A few foreign aid programs operate with single-year appropriations but, according to Department 
+of State officials, were able to operate on FY2013 money. U.S. security assistance programs 
+including International Military Education and Training (IMET), Foreign Military Financing 
+(FMF), and Peacekeeping Operations (PKO), with small exceptions, were funded only through 
+FY2013. Another significant delay in passing a FY2014 CR might be felt more immediately by 
+the recipients of these programs, such as Israel, as might U.S. support to the peacekeeping 
+mission in the Sinai, according to the Department of State.3 Multilateral assistance within the 
+International Organizations and Programs (IO&P) account also typically is funded with one-year 
+appropriations. A lack of FY2014 funding for this account could delay U.S. voluntary 
+contributions to such international entities as the U.N. Children’s Fund (UNICEF) and the U.N. 
+Development Program (UNDP). If there is another government shutdown and the balance of 
+FY2013 funding becomes insufficient, these programs funded entirely through single-year 
+appropriations will shut down until a new appropriation is enacted or unless they are deemed by 
+the relevant Chief of Mission to be necessary for the safety of human life or protection of 
+government property or for the “conduct of foreign affairs essential to national security.” A delay 
+in passing a budget could be felt more immediately by recipients of these programs. 
+
+If another shutdown occurs in FY2014 and funds lapse, both the Department of State and USAID 
+would institute procedures to cease operations other than “excepted” functions—those essential to 
+national security, including the conduct of foreign affairs.4 Among other restrictions, a hiring 
+freeze would remain in place and new security investigations would be suspended. The Foreign 
+Service Institute would be closed and training would not be authorized. In addition, the 
+Department would restrict a number of allowances, including representation allowances 
+(reimbursement for expenses while on official commission overseas), education allowances, and 
+educational travel, unless the travel is necessary for human safety. In addition to those, unpaid 
+allowances for non-excepted positions could also include post differential (such as hardship 
+posts) and danger pay. 
+
+ 
+
+2 For more detail, contact Alex Tiersky at atiersky@crs.loc.gov to obtain a general distribution memo: Potential 
+Impacts of a Lapse in Appropriations for the Department of State , October 3, 2013. 
+ 3 Department of State, “Daily Press Briefing,” press release, October 3, 2013, http://www.state.gov/r/pa/prs/dpb/2013/
+10/215092.htm. 
+4 See State Department’s Guidance on Operations during a Lapse in Appropriations at http://www.state.gov/m/rls/
+2013/214862.htm and Guidance on USAID Operations during a Lapse in Appropriations at http://www.usaid.gov/sites/
+default/files/documents/1868/GuidanceonUSAIDOperationsduringaLapseinAppropriation9_27_13.pdf. 
+
+Congressional Research Service 
+
+2 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ FY2014 State-Foreign Operations Overview 
+
+The Administration’s FY2014 request of $51.84 billion for State, Foreign Operations, and Related 
+Programs represents about 1.4% of the total budget request for FY2014. It is 5.3% less than the 
+FY2013 request and about 0.8% less than the FY2013 post-sequester funding estimate. Unless 
+otherwise noted, all of the FY2013 funding levels in this report reflect estimated funding levels 
+after both sequestration and across-the-board rescissions are applied. 
+
+The State Department and related agencies request of $16.88 billion (including the mandatory 
+Foreign Service Retirement and Disability Fund) represents a decline of 4.5% from the estimated 
+FY2013 funding level of $17.68 billion. About $35.1 billion is requested for foreign operations 
+accounts, which is a 1.6% increase from the FY2013 estimated funding of $34.56 billion. 
+However, the FY2014 foreign operations request includes funding for Food for Peace programs 
+that are currently funded through the Department of Agriculture appropriation. As a result, the 
+FY2014 request for Agriculture programs within the 150 budget decreases dramatically from the 
+FY2013-enacted funding of $1.6 billion5 to $185 million. Excluding the shifted Food for Peace 
+funds, the foreign operations request is about 2.5% lower than the FY2013 estimate. 
+
+ Overseas Contingency Operations 
+
+Since FY2012, the Administration’s international affairs budget has distinguished between what it 
+has interchangeably called “core,” “base,” or “enduring,” funding and funding to support 
+“overseas contingency operations” (OCO), described in budget documents as “extraordinary, but 
+temporary, costs of the Department of State and USAID in Iraq, Afghanistan, and Pakistan.”6 
+Congress has adopted this approach, but has defined OCO more broadly. In each of the last two 
+years, Congress has appropriated more OCO funding than requested, and for a broader range of 
+countries and activities. The FY2014 request continues this pattern. Of the total funding requested 
+for State-Foreign Operations in FY2014, $3.81 billion was designated as OCO. 
+
+ Congressional Action 
+
+On July 25, 2013, the Senate Appropriations Committee passed its FY2014 State-Foreign 
+Operations spending bill, S. 1372. The House Appropriations Committee approved H.R. 2855, a 
+State-Foreign Operations appropriations bill for FY2014, on July 30, 2013. The House bill 
+includes $40.78 billion in spending, net of rescissions, or about 21.3% below the FY2014 request 
+and 21.9% below the FY2013 funding estimate. The Senate bill totals $49.49 billion, which is 
+4.5% less than requested and 5.3% less than FY2013 funding. (See Table 1 below.) On January 
+13, 2014, after extensive negotiations, appropriations leaders reached a spending agreement and 
+introduced a Consolidated Appropriations Act, 2014 (an amendment to H.R. 3547), which was 
+approved by the House on January 15. 
+
+ 
+
+5 A post-sequester estimate is not yet available for this account. 
+6 From Executive Budget Summary, Function 150 & Other International Programs, Fiscal Year 2014, p. 97. 
+
+Congressional Research Service 
+
+3 
+
+ 
+ 
+
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Table 1. Status of State-Foreign Operations Appropriations, FY2014 
+
+(funding in billions of current U.S. dollars) 
+
+ Committee 
+
+ Public 
+
+ 302(b) Allocationsa 
+
+ Action Floor 
+
+ Action 
+
+ Conference/Agreement 
+
+ Law 
+
+House Senate House 
+
+Senate
+
+House Senate House Senate Agreement 
+
+H.R. 
+
+ S. 
+
+2855 
+
+1372 
+
+5/21/13 6/20/13 7/30/13 
+
+7/25/13 
+
+ 1/15/14 
+
+ 
+
+ 
+
+$40.78 $47.87 $40.78 
+
+$49.49 
+
+ $49.16 
+
+ 
+
+ 
+
+a. The Congressional Budget and Impoundment Control Act of 1974 established a congressional budget 
+
+process. The act, as amended, includes a requirement that the House and Senate allocate funds to the 
+Appropriations Committee, which are then divided among the 12 subcommittees, as required by Section 
+302(b). 
+
+The steepest cuts in the House bill would be applied to the Foreign Operations accounts (-23.7% 
+from the request and -22.5% from FY2013), though State Department accounts would also be 
+reduced significantly (-12.4% from the request and -16.4% from FY2013). The Senate bill, in 
+contrast, proposes relatively minimal reductions to foreign operations accounts (-2.3% from the 
+request and -0.8% from the FY2013 estimate), but somewhat larger cuts for the State Department 
+and related programs (-2.5% from the request and -7% from FY2013). Both the House and Senate 
+bills designate about $6.5 billion as OCO funding, or 71% more than the $3.8 billion requested as 
+OCO for FY2014 ( Figure 1 ). Account level data for each proposal is available in the Appendix . 
+
+ Figure 1. State & Foreign Operations Appropriations, FY2012, FY2013, FY2014 
+
+ Request and the FY2014 House and Senate Proposals 
+
+(in billions of current U.S. dollars) 
+
+ 
+
+ Source: FY2012 data are from the FY2014 CBJ; FY2013 data are from tables provided to CRS by the State 
+Department; FY2014 House data are from H.Rept. 113-185; Senate data are from S.Rept. 113-81. 
+
+Congressional Research Service 
+
+4 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ FY2014 State Operations Request Overview 
+
+The Administration has requested $16.88 billion for the State Department and related agencies in 
+FY2014. The request seeks $12.18 billion for administration of foreign affairs accounts that 
+include the mandatory Foreign Service Retirement and Disability Fund, a 9.4% decrease from the 
+FY2013 estimated funding level. The decrease is largely attributable to a $2.3 billion reduction in 
+OCO Iraq operations funds as the U.S. presence and footprint in that country are reduced. (See 
+ Table 2 below.) 
+
+The Diplomatic and Consular Programs (D&CP) account, the operating account of the 
+Department of State, would see a 12% decline from the FY2013 post-sequester estimate. This is 
+largely due to a $3.1 billion decrease in requested OCO funding in that account. Non-OCO or 
+“enduring” funding for D&CP would actually rise by 12% from the FY2013 estimated funding 
+level. 
+
+The request for Embassy Security, Construction and Maintenance, the State Department’s second-
+largest administrative account, calls for $2.65 billion to continue efforts to provide for more 
+secure facilities abroad. While this represents a 6% reduction from the FY2013 post-sequester 
+funding estimate, it is a 60.6% increase from the FY2012 actual level. Among other large 
+accounts, total contributions to International Organizations and Peacekeeping Operations would 
+rise by about 8.3% compared to the FY2013 post-sequester estimate, while funding for 
+international broadcasting activities would increase by about 2.8% and funds for Educational and 
+Cultural Exchange Programs would decline by about 1%. 
+
+ Table 2. State Department & Related Programs: Total Funding and Select Accounts 
+
+(in billions of current U.S. dollars) 
+
+ FY2013 post- 
+
+ % change, 
+
+ sequester 
+
+ FY2013 to 
+
+ 
+
+ FY2012 Actual 
+
+ estimate FY2014 
+
+ Request 
+
+ FY2014 Req. 
+
+ Total, State & Related 
+
+ 18.01 
+
+ 17.68 
+
+ 16.88 
+
+ -4.5% 
+
+ Programs 
+
+Diplomatic and Consular 
+
+10.86 9.66 8.48 
+
+-12.2 % 
+
+Programs 
+
+Embassy Security 
+
+1.65 2.82 2.65 -6.0 % 
+
+Construction and 
+Maintenance 
+
+Educational and Cultural 
+
+0.60 0.57 0.56 -1.8 % 
+
+Exchange Programs 
+
+Contributions to Int. 
+
+3.38 3.39 3.67 
+
++8.3 % 
+
+Organizations/ 
+Peacekeeping 
+
+International Broadcasting 
+
+0.75 
+
+0.71 
+
+0.73 
+
++2.8 % 
+
+Other 0.77 
+
+0.53 
+
+0.79 
+
++49.1% 
+
+ Source: Department of State, FY2014 Congressional Budget Justification Executive Summary; CRS calculations. 
+
+ Notes: Totals include mandatory funding for the Foreign Service Retirement and Disability Fund. Percentage 
+change calculations use the detailed account numbers in the Appendix , not the rounded numbers presented in 
+the table. “Other” includes accounts and commissions not included in the table. 
+
+Congressional Research Service 
+
+5 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ State Operations Key Issues 
+
+ Diplomatic Security 
+
+The dangers to U.S. diplomats abroad have been underscored by a number of recent attacks on 
+U.S. facilities and personnel. These include the death of the U.S. Ambassador and three other 
+U.S. personnel in an attack in Benghazi, Libya, on September 11, 2012; attacks on U.S. 
+embassies in Egypt, Sudan, Tunisia, and Yemen, on the same day; the bombing of U.S. Embassy 
+Ankara on February 1, 2012; and the death of U.S. Foreign Service Officer Anne Smedinghoff in 
+Afghanistan on April 6, 2013.7 The protection of U.S. government employees and facilities 
+abroad under Chief of Mission authority from terrorist, criminal, or technical attack is the 
+responsibility of the Secretary of State.8 
+
+The Accountability Review Board on the Benghazi attack urged State to work with Congress to 
+increase resources for diplomatic security and allow for more flexibility in the application of 
+those resources. In December 2012, the Secretary of State presented an Increased Security 
+Proposal to Congress, which requested authority to transfer $1.3 billion in OCO funds previously 
+appropriated for Iraq operations towards diplomatic security needs. Of that, $553 million would 
+be for additional Marine security guards worldwide, $130 million for 151 new diplomatic security 
+personnel, and $736 million for improved security at overseas facilities. While the transfer 
+authority was not provided by the 112th Congress, Section 1707 of the Consolidated and Further 
+Continuing Appropriations Act of 2013 (H.R. 933, P.L. 113-6) provided additional funding for 
+diplomatic security ($918 million for Worldwide Security Protection, to remain available until 
+expended; and $1.3 billion for Embassy Security, Construction, and Maintenance), while 
+rescinding $1.1 billion in unobligated balances from FY2012 OCO funds. 
+
+The Administration’s FY2014 request seeks to sustain the initiatives launched under the FY2013 
+Increased Security Proposal, including expansion of the Bureau of Diplomatic Security and 
+further growth in the number of Marine Security Guard detachments deployed to diplomatic 
+facilities. The request seeks $2.2 billion for construction of new secure diplomatic facilities, a 
+combination of enduring funding, OCO funding, and other agency contributions. The request for 
+Embassy Security, Construction and Maintenance of $2.65 billion (including OCO) is 6% less 
+than the FY2013 post-sequester estimate, but a 60.6% increase from the FY2012 actual level. 
+Within this account, Worldwide Security Upgrades funding (for bricks and mortar security needs, 
+including construction of secure new embassy compounds) would decrease 15% from the 
+FY2013 post-sequester estimate to $1.61 billion, but remain 108% above the FY2012 funding 
+level, while Ongoing Operations would increase by 18%. Worldwide Security Protection funds 
+(for security programs including a worldwide guard force), under Diplomatic and Consular 
+Programs, would decrease by 3% from FY2013, to $2.18 billion. 
+
+ 
+
+7 For more information on issues pertaining to diplomatic security, see CRS Report R42834, Securing U.S. Diplomatic 
+Facilities and Personnel Abroad: Background and Policy Issues , by Alex Tiersky and Susan B. Epstein. 
+8 As designated under the Omnibus Diplomatic Security and Antiterrorism Act of 1986, as amended, 22 U.S.C. §4801 
+et seq., P.L. 99-399. 
+
+Congressional Research Service 
+
+6 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Management and Human Resources of the Department of State 
+
+Many observers suggest that the Department of State chronically faces significant personnel 
+shortfalls, a situation worsened in recent years by a growing number of overseas positions to fill. 
+The ranks of mid-level Foreign Service officers (FSOs) are particularly thin, forcing junior 
+personnel to serve in assignments meant for personnel of higher rank.9 In the past few years, to 
+address this deficiency as well as the need to better train its employees, the State Department 
+increased hiring under its Human Resources Initiative, growing the FS by approximately 18%; 
+however, hiring slowed significantly in FY2011-FY2012 due to budget constraints. 
+
+The Administration’s FY2014 request seeks to grow its Human Resources account (under 
+Diplomatic & Consular Programs) by 5% over its FY2012 level, to a total of $2.60 billion.10 
+While the Administration’s FY2014 request indicates that it plans 186 new positions at the 
+Department of State altogether, 151 of these would be funded by consular fees and devoted to 
+meeting increasing visa demand. The remaining 35 new positions (30 Foreign Service, 5 Civil 
+Service) for which State seeks appropriated funding would be focused on the high priorities of the 
+“re-balance” to Asia, and to staffing the Secretary’s Office of the Coordinator for Cyber Issues. 
+As a point of comparison, the State Department requested appropriated funding for 121 new 
+positions in its FY2013 request, and for 133 in its FY2012 request. 
+
+Among its initiatives to address workforce needs, the department seeks $81.4 million in FY2014 
+funding to provide an overseas comparability pay (OCP) adjustment intended to bring the base 
+pay of Foreign Service personnel posted overseas to levels comparable to their Foreign Service 
+colleagues serving in Washington, DC, who receive locality pay. OCP advocates argue that the 
+discrepancy affects morale and retention of FSOs and acts as a financial disincentive to serve 
+overseas, including by its cumulative impact on retirement pay. The requested funding would 
+provide a third and final tranche of OCP adjustment; two-thirds of the gap was addressed through 
+prior year funding. The department’s similar FY2013 request for OCP adjustment was not 
+supported by appropriators. 
+
+ Expeditionary Diplomacy and Key Regional Initiatives 
+
+ Reduced Resources for the Frontline States 
+
+State Operations resources for the frontline states of Iraq, Afghanistan, and Pakistan would all 
+decrease under the Administration’s FY2014 budget request, compared to FY2012.11 
+
+In Iraq, the Department of State became the lead agency for all U.S. programs after the departure 
+of U.S. military forces in late 2011. An initially ambitious presence has been dramatically 
+curtailed in the last year, due to a number of factors including resource constraints and what some 
+observers suggest were overly ambitious initial plans and Iraq’s intent to assert its independence 
+from U.S. tutelage. It also reduces further the department’s footprint by closing the Erbil 
+Diplomatic Support Center (to be replaced by a new consulate) and handing over other sites to the 
+ 
+
+9 U.S. Government Accountability Office, Department of State: Foreign Service Midlevel Staffing Gaps Persist Despite 
+Significant Increases in Hiring , GAO-12-721, June 2012, p. 1, http://www.gao.gov/assets/600/591595.pdf. 
+10 FY2013 post-sequestration levels are not yet available for this account. 
+11 FY2013 post-sequester country allocations are not yet available. 
+
+Congressional Research Service 
+
+7 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+Iraqi government, thereby reducing sustainment and security contract costs. Including foreign 
+assistance, the Administration requests $1.18 billion for its activities in Iraq, including $0.65 
+billion in Ongoing Operations OCO funding. The request is $2.4 billion lower than the FY2012 
+actual level. 
+
+ The U.S. presence in Afghanistan is also evolving as the international combat mission is slated to 
+end in 2014. The President’s overall budget request for Afghanistan is $3.1 billion, including $2.2 
+billion in assistance and $0.9 billion to support decreasing numbers of civilian personnel under 
+the State Department presence in Kabul and in four key regions. Ongoing Operations OCO 
+funding under the request would decrease by $0.71 billion from FY2012 levels, although 
+Worldwide Security Protection (WSP) OCO funding would increase to $0.37 billion, a jump of 
+96%. 
+
+Funds requested for Pakistan, including foreign assistance, total $1.3 billion. OCO funding for 
+Ongoing Operations ($0.04 billion) and WSP ($0.02 billion) both decrease under the FY2014 
+proposal, by 61% and 50%, respectively, compared to FY2012 funding. 
+
+ The “Rebalancing” to Asia 
+
+In the fall of 2011, the Obama Administration announced its intent to expand and intensify the 
+already significant U.S. role in the Asia-Pacific, particularly in Southeast and South Asia. Goals 
+underpinning this “rebalancing”—or “pivot”—to Asia include tapping into the economic 
+dynamism of the region and influencing the development of the Asia-Pacific’s norms and rules, 
+particularly as China’s regional influence grows. To this end, the Administration has, among other 
+actions, announced new military deployments to and partnerships with Australia, Singapore, and 
+the Philippines; joined the East Asia Summit; and secured progress in negotiations with 10 other 
+nations to form a Trans-Pacific Strategic Economic Partnership (TPP) free trade agreement. 
+
+With some critics suggesting that the “rebalancing” has, to date, been overly focused on military 
+deployments and initiatives, the FY2014 request emphasizes the State Department’s role in 
+resourcing the re-balancing to Asia. In addition to a 7% increase in foreign assistance to the 
+region, compared to FY2012, the department seeks 29 new positions (of which 22 are Foreign 
+Service) with the intention of deploying additional Economic and Political/Military officers at 
+key posts across Asia. The request seeks $1.2 billion overall for Asia and the Pacific, including 
+$0.77 billion in assistance and $0.42 billion for operations in support of initiatives such as new 
+facilities in China, Laos, Papua New Guinea, and Burma. Still, the requested 4.4% increase in 
+FY2014 enduring State Operations funding for the East Asia and Pacific Bureau, compared to 
+FY2012, is smaller than proposed increases for the Africa Bureau at +9.4% and the Near East 
+Bureau without Iraq at +11.8%. 
+
+ FY2014 Foreign Operations Request Overview 
+
+The Foreign Operations budget funds most traditional foreign aid programs, including bilateral 
+economic aid, multilateral aid, security assistance, and export promotion programs. It has not 
+traditionally funded food aid. Funding for U.S. Agency for International Development (USAID) 
+operations is also part of the foreign operations budget. 
+
+Congressional Research Service 
+
+8 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+The FY2014 request of $35.095 billion for these programs would be about a 1.5% increase from 
+the FY2013 estimated funding. However, this total includes funding for food aid programs that 
+are not currently funded through foreign operations accounts. Excluding the roughly $1.5 billion 
+in food aid shifted to these accounts, the FY2014 foreign operations request is about 2.3% below 
+the FY2013 estimate. Breaking the request down by appropriations title shows proposed shifts in 
+foreign assistance programming at the broad level ( Table 3 ): 
+
+• Bilateral Economic Assistance, including funding for independent agencies, 
+
+makes up about 64.5% of the FY2014 foreign assistance request. Bilateral aid 
+would increase by 2.9% over FY2013 estimates, largely as a result of the 
+proposed shift of food aid out of the agriculture bill and into bilateral assistance 
+accounts. The $580 million requested for a new Middle East and North Africa 
+Incentive Fund also contributes to the increase. 
+
+• Security assistance accounts for about 24% of the proposed foreign aid budget, 
+
+with proposed funding at 6% less than the FY2013 post-sequester estimate. 
+Almost every security assistance account would be reduced compared to FY2013 
+estimates. However, total enduring security assistance funds would increase 11% 
+from FY2013, reflecting an Administration effort to shift security assistance 
+away from OCO for frontline states and into enduring activities. 
+
+• Multilateral aid makes up about 9% of the foreign aid budget request, and would 
+
+increase by about 13% over FY2013 estimated levels. Increases are spread over 
+many accounts. 
+
+ Table 3. Foreign Aid by Appropriations Title, FY2012 Actual and FY2014 Request 
+
+(in millions of current U.S. dol ars) 
+
+ FY2013 post- 
+
+ % change, 
+
+ FY2012 
+
+ sequester 
+
+ FY2014 
+
+ FY2013 to 
+
+ 
+
+ Actual 
+
+ estimate 
+
+ Request 
+
+ FY2014 Req. 
+
+USAID Administration 
+
+1,528.00 
+
+1,450.80 
+
+1,571.34 
+
++8.3% 
+
+Bilateral Economic Aid 
+
+22,194.80 
+
+22,133.45 
+
+22,770.04 
+
++2.9% 
+
+Security Assistance 
+
+9,749.59 
+
+9,070.95 
+
+8,524.39 
+
+-6.0% 
+
+Multilateral Aid 
+
+2,966.29 
+
+2,819.35 
+
+3,196.44 
+
++13.4% 
+
+Export Promotion, net 
+
+(1,015.44) 
+
+(913.00) 
+
+(966.76) 
+
+-5.9% 
+
+Total Foreign Operationsa 35,423.24 
+
+34,561.55 
+
+35,095.45 
+
++1.5% 
+
++ Food Aid from Ag bil 
+
+1,650.00 
+
+1,536.55 
+
+185.13 
+
+-88.0% 
+
+ Total Foreign Aid 
+
+ 37,073.24 
+
+ 36,098.10 
+
+ 35,280.58 
+
+ -2.3% 
+
+ Source: FY2014 International Affairs Budget, Executive Summary; CRS calculations. 
+
+ Notes: FY12 data do not reflect rescissions. Independent agencies and Treasury Department accounts under 
+Bilateral Economic Assistance. Does not include the International Trade Commission and the Foreign Claims 
+Settlement Commission, which were included in the Foreign Operations total in FY2014 budget request 
+materials. 
+
+a. Totals do not include funding for related international commissions within Commerce, Justice, Science 
+
+appropriations. 
+
+Congressional Research Service 
+
+9 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+Many of the top 10 recipients of foreign assistance would be the same under the FY2014 request 
+as in FY2012 ( Table 4 ).12 The top recipient list is dominated by strategic allies in the Middle East 
+and Southeast Asia, as well as top global health program recipients in Africa. Israel would 
+continue to be the top U.S. aid recipient, at $3.1 billion, a $25 million increase over FY2012 
+funding. Afghanistan would again rank second among recipients, though with a slightly smaller 
+allocation compared to FY2012. Iraq would drop out of the top five, with elimination of the 
+Police Development Program driving a 55% funding cut, while Nigeria would move up to 
+number five with a proposed allocation of $693 million, a 7% increase over actual FY2012 
+funding intended to bolster health and conflict prevention programs. Together, the top 10 
+recipients would account for about 37% of total bilateral economic and security assistance funds 
+in the FY2014 budget proposal. 
+
+ Table 4. Top 10 Recipients of U.S. Foreign Assistance, FY2012 Actual 
+
+ and FY2014 Request 
+
+(in millions of current U.S. dol ars) 
+
+ FY2012 Actual 
+
+ 
+
+ FY2014 Req. Est. 
+
+1. Israel 
+
+3,075 
+
+ 
+
+1. Israel 
+
+3,100 
+
+2. Afghanistan 
+
+2,286 
+
+ 
+
+2. Afghanistan 
+
+2,200 
+
+3. Pakistan 
+
+1,821 
+
+ 
+
+3. Egypt 
+
+1,600 
+
+4. Egypt 
+
+1,556 
+
+ 
+
+4. Pakistan 
+
+1,200 
+
+5. Iraq 
+
+1,270 
+
+ 
+
+5. Nigeria 
+
+693 
+
+6. Jordan 
+
+776 
+
+ 6. 
+
+Jordan 
+
+671 
+
+7. Ethiopia 
+
+707 
+
+ 
+
+7. Iraq 
+
+573 
+
+8. Nigeria 
+
+647 
+
+ 
+
+8. Kenya 
+
+564 
+
+9. South Sudan 
+
+620 
+
+ 
+
+9. Tanzania 
+
+553 
+
+10. South Africa 
+
+542 
+
+ 
+
+10. Uganda 
+
+456 
+
+ Source: FY2014 data from the Executive Summary, International Affairs Budget, FY2014. FY2012 data are 
+calculated from data provided in FY2014 budget materials provided by the State Department as wel as 
+http://www.foreignassistance.gov. 
+
+ Note: FY2013 estimates are not included because FY2013 country-level funding data are not yet available. 
+
+ Foreign Operations Key Issues 
+
+ Support for Middle East and North Africa Transitions 
+
+Political transitions and unrest in the Middle East and North Africa may have significant 
+implications for U.S. national security goals, including protecting global oil supplies, enhancing 
+intelligence/military cooperation, ensuring military access and force projection, and promoting 
+
+ 
+
+12 Country level allocations are not yet available for FY2013. 
+
+Congressional Research Service 
+
+10 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+Arab-Israeli peace. The rise of new leaders in the region represents both risks and opportunities, 
+as the Administration and lawmakers consider how to respond in a manner that best promotes 
+U.S. strategic interests and democratic values. 
+
+Last year, the Administration requested an appropriation of $770 million (of which $700 million 
+was new funding) to create a new Middle East North Africa Incentive Fund (MENA IF) that 
+would provide flexible resources to meet diverse and rapidly evolving needs in the region. 
+Congress neither authorized nor appropriated any MENA IF funding in FY2013 continuing 
+resolutions. In the 112th Congress, House and Senate Foreign Operations Appropriations bills 
+differed over MENA IF. A Senate bill would have funded it at $1 billion while a corresponding 
+House measure would not fund it at all, proposing instead $200 million for Middle East response 
+spending. Some lawmakers have expressed significant reservations about the broad spending 
+authorities sought by the Administration’s MENA-IF proposal as well as assisting some entities 
+that would be likely candidates for MENA IF assistance. 
+
+For FY2014, the Administration has again requested funding for a MENA IF. The request calls 
+for $580 million, of which $105 million would be for the existing Middle East Partnership 
+Initiative and USAID Middle East Regional Office. The Administration request does not specify 
+how the funds would be allocated, but explains that they would be used to cover interventions 
+such as “support to Syrian opposition, humanitarian assistance, Enterprise Funds, and loan 
+guarantees” that are already being funded in the region through reallocations of existing funds, 
+“at great opportunity cost.” The MENA IF, the Administration asserts, would increase flexibility 
+and transparency with respect to these activities, and “begin to address the imbalance between our 
+security and economic assistance in the region.” 
+
+ Overseas Contingency Operations 
+
+As described earlier, since FY2012, the Administration’s international affairs budget has 
+distinguished between what it has interchangeably called “core,” “base,” or “enduring,” funding 
+and funding to support “overseas contingency operations” (OCO), described in budget documents 
+as “extraordinary, but temporary, costs of the Department of State and USAID in Iraq, 
+Afghanistan, and Pakistan.”13 In FY2012, Congress increased foreign operations funds designated 
+as OCO by 52% over the requested level, including funds for Somalia, Yemen, and Kenya. The 
+FY2013 full-year CR included unrequested OCO funds for disaster assistance and migration and 
+refugees assistance, without language restricting it by country. 
+
+For FY2014, the Administration continues with its approach, requesting $2.308 billion in foreign 
+operations OCO funds for Iraq, Afghanistan, and Pakistan. This represents a 65% decline from 
+the FY2012 OCO appropriation and a 40% reduction from the FY2013 OCO request (country-
+level OCO funding levels are not yet available for FY2013). The downward trend in foreign aid 
+designated as OCO reflects significantly scaled down programming in Iraq and Pakistan, 
+countered by a slight increase, over FY2012 funding, in Afghanistan: 
+
+• Iraq. Termination of the Iraq Police Development Program, once the largest U.S. 
+
+assistance program in Iraq, is the justification for a sharp decline in foreign aid 
+OCO to Iraq, from $1,270 million in FY2012 to $500 million in the FY2014 
+request. The requested FY2014 OCO funds would support democratic 
+
+ 
+
+13 From Executive Budget Summary, Function 150 & Other International Programs, Fiscal Year 2014, p. 97. 
+
+Congressional Research Service 
+
+11 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+institutions and civil society, promote economic reform, protect vulnerable 
+populations, and develop security institutions. 
+
+• Afghanistan. While the Administration has requested more OCO aid money to 
+
+Afghanistan in FY2014 ($1,445 million) than it did in FY2012 or FY2013, the 
+request is 33% below the FY2012 actual OCO funding. The request would 
+support a broad range of activities and is intended to uphold U.S. commitments 
+made at the 2012 Tokyo Conference on Afghanistan. 
+
+• Pakistan. The FY2014 request includes $281.2 million for OCO aid to Pakistan, 
+
+a sharp drop from the requests and enacted funding in prior years. The drop 
+reflects the elimination of the Pakistan Counterinsurgency Capability Fund (for 
+which significant prior year funding is still available). Civilian assistance 
+programs would be funded near prior-year levels. 
+
+ Table 5 compares requested and enacted foreign operations OCO from FY2012, the FY2013 
+request, and the FY2014 request. 
+
+ Table 5. Overseas Contingency Operations Funding in Foreign Operations Accounts, 
+
+ FY2012, FY2013 Request, and FY2014 Request 
+
+(in millions of current U.S. dol ars) 
+
+ FY2012 
+
+ FY2012 
+
+ Req. 
+
+ Actual 
+
+ FY2013 Req. 
+
+ FY2014 Req. 
+
+Foreign Operations OCO, total 
+
+4,316.60 
+
+6,573.80 
+
+3,882.87 
+
+2,308.20 
+
+ Iraq 
+
+2,000.00 
+
+1,170.50 
+
+1,750.00 
+
+500.00 
+
+ 
+
+Afghanistan 
+
+1,216.60 2,162.80 
+
+1,237.87 1,445.00 
+
+ Pakistan 
+
+1,100.00 
+
+1,610.10 
+
+800.00 
+
+281.20 
+
+ Other 
+
+0.00 
+
+1,630.50 
+
+95.00 
+
+82.00 
+
+As % of total Foreign Ops funding 
+
+10.73% 
+
+18.25% 
+
+10.76% 
+
+6.57% 
+
+ Source: FY2012 and FY2013 Congressional Budget Justifications, Regional Annex; FY2014 Budget Request. 
+
+ Note: FY2013 country-level funding data is not yet available. 
+
+ Food Aid Reform 
+
+The International Affairs budget has supported international food assistance for decades, 
+primarily through the Food for Peace (donated U.S. agricultural commodities) and Food for 
+Education (school feeding and maternal, infant, and child nutrition) programs. Unlike most 
+foreign assistance, these programs have been authorized in farm bills and received appropriations 
+through the Agriculture appropriations bill. In recent years, appropriations to these two programs 
+totaled more than $1.5 billion annually. 
+
+Development professionals have long raised concerns about the efficiency and effectiveness of 
+U.S. food assistance, which is subject to several restrictions. With some exceptions, Food for 
+Peace commodities must be bought from U.S. producers and shipped on U.S. vessels. In recent 
+years, the U.S. Department of Agriculture operated a pilot project to evaluate local and regional 
+procurement of food aid commodities, while USAID carried out cash-based food security 
+assistance (local and regional purchase, cash vouchers, cash transfers) through the International 
+
+Congressional Research Service 
+
+12 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+Disaster Assistance program (up to $300 million). While most U.S. food aid is used to provide 
+emergency humanitarian relief, some food aid commodities are provided to U.S. 
+nongovernmental organizations to be sold (“monetized”) on local or regional markets and the 
+proceeds used for development programs related to hunger and nutrition. Critics contend that U.S. 
+procurement and shipping requirements, together with monetization practices, make food aid 
+highly inefficient and ineffective. 
+
+In the FY2014 budget, the Administration requests $1.821 million for international food aid in 
+three accounts. Under the food aid reform, the Administration proposes to shift $1.1 billion of 
+Food for Peace funds to the International Disaster and Famine Assistance account for emergency 
+food response. In FY2014, 55% of this funding, about $600 million, would still be used to 
+procure and ship U.S. produced commodities. Together with $300 million of IDA funds for cash-
+based food security programs, total emergency food aid would be $1.4 billion in FY2014. The 
+Administration’s budget also proposes to shift $250 million to Development Assistance (DA) for 
+a Community Development and Resilience Fund (CDRF). Feed the Future funding of $80 million 
+would be used to augment the CRDF, making its total $330 million. The CDRF would effectively 
+replace the current $400 million “safe box” for nonemergency development food aid provided in 
+the 2008 farm bill. Presumably, U.S. NGOs that currently carry out food aid programs would 
+participate in these CDRF programs. The Administration maintains that by removing cost 
+inefficiencies of the Food for Peace program, such as monetization, the same level of 
+nonemergency program activity would be supported and more people would be reached. Finally, 
+the Administration’s budget proposes to create a new Emergency Food Assistance Contingency 
+Fund ($75 million) to provide emergency food assistance for unexpected and urgent food needs. 
+
+ Humanitarian Assistance 
+
+Humanitarian assistance is intended to save lives and meet basic human needs in the wake of 
+natural disasters and conflicts. In FY2012, humanitarian assistance funding totaled $4.563 billion. 
+The FY2013 full-year continuing resolution increased funding over the FY2012 level for two key 
+humanitarian assistance accounts. International Disaster & Famine Assistance (IDA) increased 
+from $1.095 billion to an estimated $1.55 billion (post-sequester estimate), with the increased 
+funds designated as OCO. The Migration and Refugee Assistance (MRA) account increased from 
+$1.975 billion to $2.704 billion (post-sequester estimate), also with OCO funds. In addition, the 
+Administration transferred previously appropriated OCO funds for the Pakistan 
+Counterinsurgency Capability Fund to the MRA account to respond to the crisis in Syria. 
+
+The Administration’s FY2014 budget includes $4.131 billion for humanitarian assistance 
+accounts, including $1.761 billion for MRA, $2.045 billion for IDA, $0.25 billion for Emergency 
+Refugee and Migration Assistance (of which $0.20 billion is specifically for Syria), and $0.075 
+billion for a new Emergency Food Assistance Contingency Fund. Of the IDA funds, $0.629 
+billion are allocated to USAID’s Office of Foreign Disaster Assistance to respond to natural 
+disaster, civil strife, food security, and displaced populations. The remaining $1.416 billion is 
+designated for Food for Peace activities currently funded through the Agriculture appropriation 
+(see Food Aid above). In total, the humanitarian assistance request is about 27% below the 
+FY2013 post-sequester estimate, due in part to $0.25 billion in food aid being moved to the 
+Development Assistance account. 
+
+Congressional Research Service 
+
+13 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ Ongoing Administration Initiatives 
+
+The Obama Administration introduced three major foreign assistance initiatives in 2009 and 
+2010—the Global Health Initiative, the Food Security Initiative (Feed the Future), and the Global 
+Climate Change Initiative—which continue to be priorities in the FY2014 budget request. 
+
+• Global Health Initiative. The request includes $8.315 billion for global health 
+
+programs, a 3% increase over the FY2013 post-sequester estimate. Several 
+programs would see mostly modest increases over FY2012 funding: Malaria 
+(+3%), Maternal and Child Health (+12%), and Family Planning and 
+Reproductive Health (+1%). Others would see significant cuts: Tuberculosis (-
+19%), Pandemic Influenza (-19%), Neglected Tropical Diseases (-4%), and 
+USAID HIV/AIDS (-6%), though FY2013 allocations for these subaccounts are 
+not yet available. The Administration asserts that the requested funding will 
+allow the continuation and scale-up of HIV/AIDS prevention, care, and treatment 
+activities and meet pledged commitments to multilateral efforts. 
+
+• Food Security Initiative. Feed the Future (FtF) is the Administration’s food 
+
+security initiative, designed to support long-term country-led agricultural growth 
+and nutrition plans. For FY2014, the Administration has requested $1.191 billion 
+for Feed the Future, a 9% increase over the FY2012 funding (FY2013 data are 
+not available). The Administration’s pledge of $3.5 billion for food security 
+assistance, made at the L’Aquila G-8 summit in 2009, has been exceeded. For 
+FY2014, increased funding would be channeled to economic resilience activities 
+in regions of Africa facing chronic food insecurity. 
+
+• Global Climate Change Initiative (GCCI). The GCCI would see a 2% decrease 
+
+from FY2012 funding (FY2013 data are not yet available), including a $100 
+million transfer from ESF, with the Administration’s FY2014 request of $0.837 
+billion. Within that total, bilateral clean energy funding would increase by 7% 
+and adaptation programs by 1%, while sustainable landscapes funding would be 
+reduced by 10%. Total U.S. contributions to World Bank climate accounts would 
+decrease by 6% if the $100 million ESF transfer to these funds is calculated into 
+the FY2012 funding total.14 With FY2013 funds, the United States has met the 
+specific international climate change commitments which initially drove the 
+initiative. 
+
+ 
+
+ 
+
+14 These accounts include the Clean Technology Fund, Strategic Climate Fund, and Global Environment Fund (GEF), 
+but only about half of GEF funding related to climate change and is included in the GCCI funding calculation. 
+
+Congressional Research Service 
+
+14 
+
+ 
+ 
+
+ Appendix. State-Foreign Operations Appropriations, by Account 
+
+ Table A-1. State Department, Foreign Operations and Related Agencies Appropriations, FY2013-FY2014 
+
+(in millions of current U.S. dol ars) 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+ Title I. State, Broadcasting 
+
+ 13,267.12 4,592.58 
+
+ 17,859.70 15,384.07 1,499.14 16,883.20 
+
+ 14,779.80 
+
+ 16,456.55 14,046.49 1,817.72 15,864.21 
+
+ & Related Agencies, 
+
+ TOTAL 
+
+ Administration of Foreign Affairs, 
+
+ 8,957.40 
+
+ 4,496.37 
+
+ 13,453.77 
+
+ 10,678.23 
+
+ 1,499.14 
+
+ 12,177.37 
+
+ 11,355.91 
+
+ 11,824.17 9,947.76 
+
+ 1,723.90 11,680.66 
+
+ Subtotal 
+
+Diplomatic & Consular 
+
+6,484.28 
+
+3,178.99 
+
+9,663.27 
+
+7,282.36 
+
+1,199.49 
+
+8,484.85 
+
+7,837.54 
+
+8,114.76 
+
+6,605.70 
+
+1,391.12 
+
+7,996.82 
+
+Program 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+(of which Worldwide Security 
+
+(2,250.59) 
+
+(1,791.17) 
+
+(390.96) 
+
+(2,182.13) 
+
+(2,182.14) 
+
+(2,767.52) 
+
+ 
+
+ 
+
+Protection) 
+
+(1,867.25) 
+
+(900.27) 
+
+(2,767.52) 
+
+Capital Investment Fund 
+
+56.37 
+
+ 
+
+56.37 
+
+76.90 
+
+ 
+
+76.90 
+
+76.90 
+
+76.90 76.90 
+
+ 76.90 
+
+Embassy Security, Construction 
+
+1,581.80 
+
+1,237.54 
+
+2,819.33
+
+2,399.35
+
+250.00 
+
+2,649.35 
+
+2,649.35
+
+2,664.35
+
+2,399.35 
+
+275.00 
+
+2,674.35 
+
+& Maintenance 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+(of which Worldwide Security 
+
+(669.53) (1,227.03) 
+
+(1,896.56) 
+
+(1,614.00) 
+
+(1,614.00) 
+
+(1,614.00) 
+
+(1,320.45) 
+
+ 
+
+Upgrades) 
+
+(1,614.00) 
+
+ (1,614.00) 
+
+Conflict Stabilization 
+
+ 
+
+8.08 
+
+8.08 
+
+45.20 
+
+ 
+
+45.20 
+
+0.00 
+
+8.50 
+
+8.50 
+
+8.50 
+
+Operations 
+
+Ed. & Cultural Exchanges 
+
+553.68 
+
+14.82 
+
+568.50 
+
+562.66 
+
+ 
+
+562.66 
+
+451.34 
+
+603.63 560.00 8.63 568.63 
+
+Office of Inspector General 
+
+59.58 
+
+56.94 
+
+116.52 
+
+69.41 
+
+49.65 
+
+119.06 
+
+119.06 
+
+119.06 69.41 
+
+49.65 119.06 
+
+Representation Al owances 
+
+6.93 
+
+ 
+
+6.93 
+
+6.93 
+
+ 
+
+6.93 
+
+6.93 
+
+7.30 7.30 7.30 
+
+CRS-15 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+Protection of Foreign Missions 
+
+25.63 
+
+ 
+
+25.63 
+
+25.63 
+
+ 
+
+25.63 
+
+25.64 
+
+28.20 28.2 28.2 
+
+& Officials 
+
+Emergency-Diplomatic & 
+
+8.83 
+
+ 
+
+8.83 
+
+8.83 
+
+ 
+
+8.83 
+
+8.83 
+
+9.65 9.24 9.24 
+
+Consular Services 
+
+Repatriation Loans 
+
+1.37 
+
+ 
+
+1.37 
+
+1.37 
+
+ 
+
+1.37 
+
+1.37 
+
+1.70 1.54 1.54 
+
+Payment American Institute 
+
+20.04 
+
+ 
+
+20.04 
+
+36.22 
+
+ 
+
+36.22 
+
+20.05 
+
+31.22 31.22 
+
+ 31.22 
+
+Taiwan 
+
+Foreign Service Retirement 
+
+158.90 
+
+ 
+
+158.90 
+
+158.90 
+
+ 
+
+158.90 
+
+158.90 
+
+158.90 158.90 
+
+ 158.90 
+
+(mandatory) 
+
+ International Orgs, Subtotal 
+
+ 3,290.22 
+
+ 96.21 
+
+ 3,386.43 
+
+ 3,668.11 
+
+ 
+
+ 3,668.11 
+
+ 2,426.86 
+
+ 3,551.47 3,031.28 74.40 3,105.68 
+
+Contributions to Int’l Orgs 
+
+1,376.33 
+
+96.21 
+
+1,472.54 
+
+1,573.45 
+
+ 
+
+1,573.45 
+
+746.03 
+
+1,456.81 1,265.76 74.40 1,340.16 
+
+Contributions, International 
+
+1,913.89 
+
+ 
+
+1,913.89 
+
+2,094.66 
+
+ 
+
+2,094.66 
+
+1,680.83 
+
+2,094.66 1,765.52 
+
+ 1,765.52 
+
+Peacekeeping 
+
+ International Commission subtotal 
+
+ 112.96 
+
+ 
+
+ 112.96 
+
+ 120.96 
+
+ 
+
+ 120.96 
+
+ 111.71 
+
+ 132.96 125.92 
+
+ 125.92 
+
+Int’l Boundary/U.S.-Mexico 
+
+68.78 
+
+ 
+
+68.78 
+
+77.02 
+
+ 
+
+77.02 
+
+68.92 
+
+80.82 77.44 
+
+ 77.44 
+
+American Sections 
+
+11.31 
+
+ 
+
+11.31 
+
+12.50 
+
+ 
+
+12.50 
+
+11.34 
+
+12.80 12.5 12.5 
+
+International Fisheries 
+
+32.87 
+
+ 
+
+32.87 
+
+31.44 
+
+ 
+
+31.44 
+
+31.45 
+
+39.34 35.98 
+
+ 35.98 
+
+ International Broadcast, Subtotal 
+
+ 713.49 
+
+ 
+
+ 713.49 
+
+ 731.08 
+
+ 
+
+ 731.08 
+
+ 731.08 
+
+ 729.48 729.08 4.40 733.48 
+
+Broadcasting Operations 
+
+706.82 
+
+ 
+
+706.82 
+
+722.58 
+
+ 
+
+722.58 
+
+724.08 
+
+721.48 721.08 4.40 725.48 
+
+Capital Improvements 
+
+6.67 
+
+ 
+
+6.67 
+
+8.50 
+
+ 
+
+8.50 
+
+7.00 
+
+8.00 8.00 8.00 
+
+ Related Approps, Subtotal 
+
+ 182.47 
+
+ 
+
+ 182.47 
+
+ 173.41 
+
+ 
+
+ 173.41 
+
+ 141.97 
+
+ 206.20 200.19 6.02 206.21 
+
+Asia Foundation 
+
+16.14 
+
+ 
+
+16.14 
+
+17.00 
+
+ 
+
+17.00 
+
+13.00 
+
+17.00 17.00 
+
+ 17.00 
+
+U.S. Institute of Peace 
+
+37.03 
+
+ 
+
+37.03 
+
+35.69 
+
+ 
+
+35.69 
+
+10.71 
+
+37.00 30.98 6.02 37.00 
+
+Center for Middle East-West 
+
+0.80 
+
+ 
+
+0.80 
+
+0.09 
+
+ 
+
+0.09 
+
+0.09 
+
+0.09 0.09 0.09 
+
+Dialogue-Trust & Program 
+
+CRS-16 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+Eisenhower Exchange Programs 
+
+0.48 
+
+ 
+
+0.48 
+
+0.40 
+
+ 
+
+0.40 
+
+0.40 
+
+0.40 0.40 0.40 
+
+Israeli Arab Scholarship 
+
+0.36 
+
+ 
+
+0.36 
+
+0.01 
+
+ 
+
+0.01 
+
+0.01 
+
+0.01 0.01 0.01 
+
+Program 
+
+International Center 
+
+0.49 
+
+ 
+
+0.49 
+
+5.97 
+
+ 
+
+5.97 
+
+0.00 
+
+ 
+
+ 
+
+ 
+
+a 
+
+East-West Center 
+
+15.86 
+
+ 
+
+15.86 
+
+10.80 
+
+ 
+
+10.80 
+
+0.00 
+
+16.70 16.70 
+
+ 16.70 
+
+National Endowment for 
+
+111.80 
+
+ 
+
+111.80 
+
+103.45 
+
+ 
+
+103.45 
+
+117.76 
+
+135.00 135.00 
+
+ 135.00 
+
+Democracy 
+
+ Other Commissions subtotal 
+
+ 10.58 
+
+ 
+
+ 10.58 
+
+ 12.27 
+
+ 
+
+ 12.27 
+
+ 12.27 
+
+ 12.27 12.27 
+
+ 12.27 
+
+Preservation of America’s 
+
+0.57 
+
+ 
+
+0.57 
+
+0.69 
+
+ 
+
+0.69 
+
+0.69 
+
+0.69 0.69 0.69 
+
+Heritage 
+
+Int’l Religious Freedom 
+
+2.77 
+
+ 
+
+2.77 
+
+3.50 
+
+ 
+
+3.50 
+
+3.50 
+
+3.50 3.50 3.50 
+
+Security & Cooperation Europe 
+
+2.31 
+
+ 
+
+2.31 
+
+2.58 
+
+ 
+
+2.58 
+
+2.58 
+
+2.58 2.58 2.58 
+
+Cong.-Exec. on People’s 
+
+1.80 
+
+ 
+
+1.80 
+
+2.00 
+
+ 
+
+2.00 
+
+2.00 
+
+2.00 2.00 2.00 
+
+Republic of China 
+
+U.S.-China Economic and 
+
+3.13 
+
+ 
+
+3.13 
+
+3.50 
+
+ 
+
+3.50 
+
+3.50 
+
+3.50 3.50 3.50 
+
+Security Review 
+
+ FOREIGN OPERATIONS, 
+
+ 27,695.66 7,325.66 
+
+ 35,021.32 32,637.35 2,308.20 35,095.45 
+
+ 26,774.75 
+
+ 34,289.45 28,592.40 5,129.6 33,722.01 
+
+ TOTAL 
+
+ Title II. Admin of Foreign 
+
+ 1,204.35 
+
+ 246.45 
+
+ 1,450.80 
+
+ 1,500.34 
+
+ 71.00 
+
+ 1,571.34 
+
+ 1,355.79 
+
+ 1,519.61 1,222.17 91.04 1,313.21 
+
+ Assistance 
+
+USAID Operating Expenses 
+
+1,037.07 
+
+242.18 
+
+1,279.25 
+
+1,328.20 
+
+71.00 
+
+1,399.20 
+
+1,183.65 
+
+1,349.67 1,059.23 81.00 1,140.23 
+
+USAID Capital Investment 
+
+123.13 
+
+ 
+
+123.13 
+
+117.94 
+
+ 
+
+117.94 
+
+117.94 
+
+117.94 117.94 
+
+ 117.94 
+
+Fund 
+
+USAID Inspector General 
+
+44.15 
+
+4.27 
+
+48.42 
+
+54.20 
+
+ 
+
+54.20 
+
+54.20 
+
+52.00 45.00 
+
+10.04 55.04 
+
+ Title III. Bilateral Economic 
+
+ 17,224.84 
+
+ 4,908.61 
+
+ 22,133.45 
+
+ 22,388.22 1,382.20 
+
+ 22,770.42 
+
+ 17,306.05 
+
+ 22,149.7 18,190.81 3,894.17 22,084.99 
+
+ Assistance 
+
+CRS-17 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+Global Health Programs (GHP), 
+
+8,061.49 
+
+ 
+
+8,061.49 
+
+8,315.00 
+
+ 
+
+8,315.00 
+
+8,175.00 
+
+8,455.00 8,439.45 
+
+ 8,439.45 
+
+State + USAID 
+
+GHP (State Dept.) 
+
+[5,439.33] 
+
+ 
+
+[5,439.83] 
+
+[5,670.00] 
+
+ 
+
+[5,670.00] 
+
+[5,670.00] 
+
+[5,670.00] [5,670.00] 
+
+ [5,670.00] 
+
+GHP (USAID) 
+
+[2,621.25] 
+
+ 
+
+[2,621.66] 
+
+[2,645.00] 
+
+ 
+
+[2,645.00] 
+
+[2,505.00] 
+
+[2,785.00] [2,769.45] 
+
+ [2,769.45] 
+
+Development Assistance 
+
+2,717.67 
+
+ 
+
+2,717.67 
+
+2,837.81 
+
+ 
+
+2,837.81 
+
+2,000.00 
+
+2,507.00 2,507.00 
+
+ 2,507.00 
+
+International Disaster 
+
+799.46 
+
+750.93 
+
+1,550.39 
+
+2,045.00 
+
+ 
+
+2,045.00 
+
+929.00 
+
+1,615.00 876.83 
+
+924.17 
+
+1,801.00 
+
+Assistance (IDA) 
+
+Transition Initiatives 
+
+47.61 
+
+6.22 
+
+53.83 
+
+57.60 
+
+ 
+
+57.60 
+
+57.60 
+
+57.60 48.18 9.42 57.6 
+
+Complex Crises Fund 
+
+9.49 
+
+28.50 
+
+37.99 
+
+40.00 
+
+ 
+
+40.00 
+
+— 
+
+_ 20.00 
+
+20.00 40.00 
+
+Complex Foreign Crises fund 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+575.00 
+
+ 
+
+Emergency Food Aid 
+
+— 
+
+— 
+
+— 
+
+75.00 
+
+ 
+
+75.00 
+
+— 
+
+— 
+
+ 
+
+Contingency 
+
+Development Credit Authority 
+
+[40.00] 
+
+ 
+
+[40.00] 
+
+[40.00] 
+
+ 
+
+[40.00] 
+
+[40.00] 
+
+[40.00] [40.00] 
+
+ [40.00] 
+
+–Admin 
+
+Development Credit Authority 
+
+7.88 
+
+ 
+
+7.88 
+
+8.20 
+
+ 
+
+8.20 
+
+7.86 
+
+8.20 8.04 8.04 
+
+Subsidy 
+
+Economic Support Fund 
+
+2,573.59 
+
+3,008.94 
+
+5,582.53 
+
+4,076.05 
+
+1,382.20 
+
+5,458.25 
+
+2,909.09 
+
+4,491.40 2,982.97 
+
+1,656.22 4,639.19 
+
+Assistance for Europe; Eurasia 
+
+0.00 
+
+ 
+
+0.00b 
+
+0.00 
+
+ 
+
+0.00 
+
+0.00 
+
+0.00 
+
+ 
+
+& Central Asia (AEECA) 
+
+Middle East and North Africa 
+
+0.00 
+
+ 
+
+0.00 
+
+580.00 
+
+ 
+
+580.00 
+
+0.00 
+
+0.00 
+
+ 
+
+Incentive Fund 
+
+Democracy Fund 
+
+108.96 
+
+ 
+
+108.96 
+
+0.00 
+
+ 
+
+0.00 
+
+111.50 
+
+130.50 130.50 
+
+ 130.50 
+
+Migration & Refugee Assistance 
+
+1,590.14 
+
+1,114.02 
+
+2,704.16 
+
+1,760.96 
+
+ 
+
+1,760.96 
+
+1,985.13 
+
+2,900.00 1,774.65 
+
+1,284.36 3,059.01 
+
+Emergency Refugee and 
+
+25.82 
+
+ 
+
+25.82 
+
+250.00 
+
+ 
+
+250.00 
+
+25.83 
+
+50.00 50.00 
+
+ 50.00 
+
+Migration 
+
+ Independent Agencies subtotal 
+
+ 1,258.57 
+
+ 
+
+ 1,258.57 
+
+ 1,319.10 
+
+ 
+
+ 1,319.10 
+
+ 1,081.52 
+
+ 1,336.50 1,329.70 
+
+ 1,329.7 
+
+CRS-18 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+Inter-American Foundation 
+
+21.36 
+
+ 
+
+21.36 
+
+18.10 
+
+ 
+
+18.10 
+
+13.70 
+
+22.50 22.50 
+
+ 22.50 
+
+African Development 
+
+28.48 
+
+ 
+
+28.48 
+
+24.00 
+
+ 
+
+24.00 
+
+9.78 
+
+30.00 30.00 
+
+ 30.00 
+
+Foundation 
+
+Peace Corps 
+
+356.00 
+
+ 
+
+356.00 
+
+378.80 
+
+ 
+
+378.80 
+
+356.14 
+
+385.00 379.00 
+
+ 379.00 
+
+Millennium Challenge 
+
+852.73 
+
+ 
+
+852.73 
+
+898.20 
+
+ 
+
+898.20 
+
+701.90 
+
+899.00 898.20 
+
+ 898.20 
+
+Corporation 
+
+ Department of Treasury, subtotal 
+
+ 24.16 
+
+ 
+
+ 24.16 
+
+ 23.50 
+
+ 
+
+ 23.50 
+
+ 23.50 
+
+ 23.50 23.50 
+
+ 23.50 
+
+Treasury Department 
+
+24.16 
+
+ 
+
+24.16 
+
+23.50 
+
+ 
+
+23.50 
+
+23.50 
+
+23.50 23.50 
+
+ 23.50 
+
+Technical Assistance 
+
+Debt Restructuring 
+
+— 
+
+ 
+
+— 
+
+— 
+
+ 
+
+— 
+
+— 
+
+— 
+
+ 
+
+ Title IV. Int’l Security 
+
+ 6,900.35 
+
+ 2,170.60 
+
+ 9,070.95 
+
+ 7,669.39 
+
+ 855.00 
+
+ 8,524.39 
+
+ 8,144.39 
+
+ 8,191.09 7,366.06 
+
+ 1,144.39 8,510.45 
+
+ Assistance 
+
+International Narcotics Control 
+
+1,005.61 
+
+932.47 
+
+1,938.08 
+
+1,129.73 
+
+344.00 
+
+1,473.73 
+
+1,473.73 
+
+1,131.50 1,005.61 344.39 1,350.00 
+
+& Law Enforcement 
+
+Nonproliferation, Anti-
+
+560.27 
+
+114.59 
+
+674.86 
+
+616.13 
+
+ 
+
+616.13 
+
+616.13 
+
+700.00 630.00 70.00 700.00 
+
+Terrorism, Demining 
+
+International Military Education 
+
+100.43 
+
+ 
+
+100.43 
+
+105.57 
+
+ 
+
+105.57 
+
+105.57 
+
+105.00 105.57 
+
+ 105.57 
+
+& Training 
+
+Foreign Military Financing 
+
+4,946.53 
+
+1,046.61 
+
+5,993.14 
+
+5,445.96 
+
+511.00 
+
+5,956.96 
+
+5,907.06 
+
+5,865.00 5,389.28 530.00 5,919.28 
+
+Peacekeeping Operations 
+
+287.51 
+
+76.93 
+
+364.44 
+
+347.00 
+
+ 
+
+347.00 
+
+421.90 
+
+389.50 235.60 
+
+200.00 435.60 
+
+Pakistan Counterinsurgency 
+
+0.00 
+
+ 
+
+0.00 
+
+0.00 
+
+ 
+
+0.00 
+
+-380.00 
+
+0.00 
+
+ 
+
+Capability Fund (PCCF) 
+
+Global Security Fund 
+
+0.00 
+
+ 
+
+0.00 
+
+25.00 
+
+ 
+
+25.00 
+
+0.00 
+
+0.00 
+
+ 
+
+ Title V. Multilateral 
+
+ 2,879.84 
+
+ 
+
+ 2,879.84 
+
+ 3,196.44 
+
+ 
+
+ 3,196.44 
+
+ 1,151.44 
+
+ 3,546.49 2,960.75 
+
+ 2,960.75 
+
+ Assistance 
+
+World Bank: Global 
+
+124.84 
+
+ 
+
+124.84 
+
+143.75 
+
+ 
+
+143.75 
+
+0.00 
+
+143.75 143.75 
+
+ 143.75 
+
+Environment Facility 
+
+CRS-19 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+International Clean Technology 
+
+175.28 
+
+ 
+
+175.28 
+
+215.70 
+
+ 
+
+215.70 
+
+0.00 
+
+215.70 184.63 
+
+ 184.63 
+
+Fund 
+
+Strategic Climate Fund 
+
+47.37 
+
+ 
+
+47.37 
+
+68.00 
+
+ 
+
+68.00 
+
+0.00 
+
+68.00 49.90 
+
+ 49.90 
+
+World Bank: Int’l. 
+
+1,351.02 
+
+ 
+
+1,351.02 
+
+1,358.50 
+
+ 
+
+1,358.50 
+
+942.31 
+
+1,358.50 1,355.00 
+
+ 1,355.00 
+
+Development Association 
+
+Int. Bank Recon & Dev 
+
+180.99 
+
+ 
+
+180.99 
+
+186.96 
+
+ 
+
+186.96 
+
+0.00 
+
+186.96 186.96 
+
+ 186.96 
+
+Inter-Amer. Dev. Bank - capital 
+
+107.34 
+
+ 
+
+107.34 
+
+102.02 
+
+ 
+
+102.02 
+
+0.00 
+
+102.02 102.00 
+
+ 102.00 
+
+IADB: Enterprise for Americas 
+
+15.00 
+
+ 
+
+15.00 
+
+6.30 
+
+ 
+
+6.30 
+
+0.00 
+
+6.30 6.30 6.30 
+
+MIF 
+
+IADB: Inter-American 
+
+— 
+
+ 
+
+— 
+
+— 
+
+ 
+
+— 
+
+0.00 
+
+0.00 
+
+ 
+
+Investment Corporation 
+
+Asian Development Fund 
+
+94.94 
+
+ 
+
+94.94 
+
+115.25 
+
+ 
+
+115.25 
+
+74.54 
+
+115.25 109.85 
+
+ 109.85 
+
+Asian Development Bank – 
+
+101.19 
+
+ 
+
+101.19 
+
+106.59 
+
+ 
+
+106.59 
+
+0.00 
+
+106.59 106.59 
+
+ 106.59 
+
+capital 
+
+African Development Fund 
+
+163.45 
+
+ 
+
+163.45 
+
+195.00 
+
+ 
+
+195.00 
+
+134.59 
+
+195.00 176.34 
+
+ 176.34 
+
+African Development Bank - 
+
+30.72 
+
+ 
+
+30.72 
+
+32.42 
+
+ 
+
+32.42 
+
+0.00 
+
+62.42 32.42 
+
+ 32.42 
+
+capital 
+
+International Fund for 
+
+28.48 
+
+ 
+
+28.48 
+
+30.00 
+
+ 
+
+30.00 
+
+0.00 
+
+30.00 30.00 
+
+ 30.00 
+
+Agricultural Development 
+
+Global Food Security Fund 
+
+128.17 
+
+ 
+
+128.17 
+
+135.00 
+
+ 
+
+135.00 
+
+0.00 
+
+135.00 133.00 
+
+ 133.00 
+
+IMF funding quota increase 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+ 
+
+315.00 
+
+ 
+
+International Organizations & 
+
+331.05 
+
+ 
+
+331.05 
+
+320.65 
+
+ 
+
+320.65 
+
+0.00 
+
+355.70 344.02 
+
+ 344.02 
+
+Programs 
+
+Multilateral Debt Reliefc 
+
+— 
+
+ 
+
+— 
+
+175.30 
+
+ 
+
+175.30 
+
+0.00 
+
+145.30 
+
+ 
+
+Middle East North Africa 
+
+— 
+
+ 
+
+— 
+
+5.00 
+
+ 
+
+5.00 
+
+0.00 
+
+5.00 
+
+ 
+
+Transition Fund 
+
+CRS-20 
+
+ 
+ 
+
+ FY2014 
+
+ FY2014 
+
+ FY2013 Estimate Post-Sequestration 
+
+ House 
+
+ Senate 
+
+ 2014 Consolidated Appropriations 
+
+ & Rescissions 
+
+ Act 
+
+ (P.L. 113-6) 
+
+ FY2014 Request 
+
+ H.R. 2855 
+
+ S. 1372 
+
+ H.R. 3547 
+
+ 
+
+ Core OCO Total Core OCO Total Total Total Core OCO Total 
+
+ Title VI. Export Assistance 
+
+ (513.72) 
+
+ 
+
+ (513.72) (1,117.04) 
+
+ (1,117.04) (1,182.92) (1,117.44) (1,147.39) 
+
+ (1,147.39) 
+
+Export-Import Bank (net) 
+
+(354.35) 
+
+ 
+
+(354.35) 
+
+(959.50) 
+
+ 
+
+(959.50) 
+
+(984.50) 
+
+(959.90) (969.40) 
+
+ (969.40) 
+
+Overseas Private Investment 
+
+(206.84) 
+
+ 
+
+(206.84) 
+
+(220.20) 
+
+ 
+
+(220.20) 
+
+(245.91) 
+
+(220.20) (233.06) 
+
+ (233.06) 
+
+Corporation (net) 
+
+Trade & Development Agency 
+
+47.47 
+
+ 
+
+47.47 
+
+62.66 
+
+ 
+
+62.66 
+
+47.49 
+
+62.66 55.07 
+
+ 55.07 
+
+ STATE-FOREIGN 
+
+ 40,762.78 
+
+ 11,918.24 
+
+ 52,881.02 
+
+ 48,033.41 3,807.34 
+
+ 51,828,75 
+
+ 41,554.55 
+
+ 50,746.00 42,638.89 6,947.32 49,586.21 
+
+ OPERATIONS, TOTAL 
+
+ 
+
+ 
+
+ 
+
+ 7.00 
+
+ 
+
+ 7.00 
+
+ (772.63) 
+
+ (1,254.00) 1.00d 
+
+ (427.30)e 
+
+ (426.30) 
+
+ Add Ons/ Rescissions 
+
+ 
+
+ State-Foreign Ops Total, 
+
+ 40,762.78 11,918.24 52,881.02 48,026.41 3,807.34 51,835.75 
+
+ 40,781.92 
+
+ 49,492.00 42,639.89 6,520.02 49,159.91 
+
+ Net of Rescissions 
+
+ Source: FY13 data are from tables provided to CRS by the State Department; FY14 House data are from H.Rept. 113-185; Senate data are from S.Rept. 113-81; FY2014 
+Consolidated data is from H.R. 3547. 
+
+ Notes: Shaded columns indicate fiscal year totals. Figures in brackets are subsumed in the larger account above and are not counted against the total. Figures in 
+parentheses are negative numbers. “Core” funding is also sometimes referred to as “base” or “enduring” funding in budget documents. 
+
+a. The International center is funded through the D&CP account in the FY2014 consolidated appropriation. 
+
+b. Although no funding was requested through the AEECA account for FY2013, funding for many programs and activities currently supported by this account was 
+
+requested in the ESF, GHP and INCLE accounts. 
+
+c. Includes Multilateral Debt Relief Initiative (MDRI) funds both for the World Bank IDA and the African Development Bank. 
+
+d. This is the net add-on in Title VII reflecting an immigrant visa provision (sec. 7034(o)), additional funding for a death gratuity, and a rescission of Export-Import Bank 
+
+funds. 
+
+e. This rescission in Title VIII is from prior D&CP OCO funding. 
+
+ 
+
+CRS-21 
+
+ 
+ State, Foreign Operations, and Related Programs: FY2014 Budget and Appropriations 
+
+ 
+
+ 
+
+ 
+
+ Author Contact Information 
+ 
+Susan B. Epstein 
+
+ Marian L. Lawson 
+
+Specialist in Foreign Policy 
+
+Specialist in Foreign Assistance Policy 
+
+sepstein@crs.loc.gov, 7-6678 
+
+mlawson@crs.loc.gov, 7-4475 
+
+Alex Tiersky 
+
+ 
+
+Analyst in Foreign Affairs 
+atiersky@crs.loc.gov, 7-7367 
+
+ 
+ 
+
+Congressional Research Service 
+
+22
\ No newline at end of file
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new file mode 100644
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@@ -0,0 +1,400 @@
+A Guide to Major Congressional and Presidential Awards 
+
+ Updated December 10, 2024 
+
+ Congressional Research Service 
+
+ https://crsreports.congress.gov 
+
+ R47020 
+
+ 
+ 
+
+ Congressional Research Service 
+
+ 
+
+ SUMMARY 
+
+ 
+
+ A Guide to Major Congressional and Presidential Awards 
+
+ This report is intended to help congressional offices obtain information about awards authorized by Congress and the President. It provides details about the establishment, criteria, selection process, and presentation of five presidential and congressional awards: the Congressional Award, Congressional Gold Medal, Medal of Honor, Presidential Medal of Freedom, and Presidential Citizens Medal. It also contains basic information on 20 additional awards and medals, though this is not a comprehensive list of U.S. government decorations. 
+
+ R47020 
+
+ December 10, 2024 
+
+ Barbara Salazar Torreon Senior Research Librarian 
+
+ Ben Leubsdorf Research Librarian 
+
+ 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 
+
+ Contents 
+
+ Introduction ..................................................................................................................................... 1 Congressional Award ....................................................................................................................... 1 
+
+ Congressional Gold Medal .............................................................................................................. 1 Medal of Honor ............................................................................................................................... 2 Presidential Medal of Freedom ....................................................................................................... 2 Presidential Citizens Medal ............................................................................................................. 3 
+
+ Additional Awards and Medals ........................................................................................................ 4 
+
+ Related CRS Resources ................................................................................................................... 6 
+
+ 
+
+ Tables 
+
+ Table 1. Selected National Medals and Awards ............................................................................... 4 
+
+ 
+
+ Contacts 
+
+ Author Information .......................................................................................................................... 7 
+
+ 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 1 
+
+ Introduction 
+
+ Congress and the executive branch have established a number of awards and medals for achievement in the arts, education, military service, science, and other fields. 
+
+ Some awards, such as the Congressional Award, recognize the accomplishments of young Americans. Awards such as the Congressional Gold Medal and Presidential Medal of Freedom often honor a lifetime of exceptional achievement. Other awards, such as the Medal of Honor, recognize individual heroism. 
+
+ This report provides information on the Congressional Award, Congressional Gold Medal, Medal of Honor, Presidential Medal of Freedom, and Presidential Citizens Medal. It also includes a list of 20 additional national awards and medals. 
+
+ Congressional Award 
+
+ In 1979, Congress established the Congressional Award Program “to promote initiative, achievement, and excellence among youths in the areas of public service, personal development, and physical and expedition fitness.” 1 Overseen by the Congressional Award Board, 2 participants who are 14 to 23 years old complete a self-designed program in four program areas: voluntary public service, personal development, physical fitness, and expedition/exploration. When participants fulfill the criteria, they can earn Congressional Award Certificates (Bronze, Silver, and Gold) and Congressional Award Medals (Bronze, Silver, and Gold). 3 
+
+ Traditionally, a gold medal ceremony at the U.S. Capitol recognizes recipients each year. 4 
+
+ The program may be contacted at: 
+
+ Congressional Award Foundation P.O. Box 77440 Washington, DC 20013 Phone: (888) 80-AWARD; (202) 226-0130 Email: information@congressionalaward.org Website: https://www.congressionalaward.org 
+
+ Congressional Gold Medal 
+
+ Congressional Gold Medals are awarded by acts of Congress to express public gratitude for distinguished contributions, highlight the virtues of patriotism, and perpetuate the remembrance of great events. First issued by the Continental Congress to General George Washington in 1776, 5 the medal is considered one of the highest honors bestowed on behalf of the nation. 
+
+ 
+
+ 1 P.L. 96-114, 93 Stat. 851 (1979), codified at 2 U.S.C. §801-§808. 
+
+ 2 For information on board membership and appointments, see CRS Report RL33313, Congressional Membership and Appointment Authority to Advisory Commissions, Boards, and Groups , by Jacob R. Straus. 
+
+ 3 “The Program,” Congressional Award Foundation, https://www.congressionalaward.org/the-program. 
+
+ 4 “Annual Gold Medal Summit,” Congressional Award Foundation, https://www.congressionalaward.org/gold. 
+
+ 5 Worthington Chauncey Ford (ed.), Journals of the Continental Congress: 1774-1789 , vol. 4 (Washington: Government Printing Office, 1906), p. 234 (March 25, 1776). 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 2 
+
+ Historically, Congress has awarded Congressional Gold Medals to recognize a lifetime of contribution or a singular achievement. Each Congressional Gold Medal is individually authorized and requires the U.S. Mint to design and strike the medal. 6 
+
+ Congressional Gold Medals can be awarded to either individuals or groups. When gold medals are awarded to individuals, the individual recipient, or his or her family, receives the gold medal. For instances in which a group is honored, a single gold medal is generally minted that is either awarded to the group or placed in a museum for future exhibition. 
+
+ For additional information including a full list of Congressional Gold Medal recipients, see CRS Report R45101, Congressional Gold Medals: Background, Legislative Process, and Issues for Congress , by Jacob R. Straus. 
+
+ Medal of Honor 
+
+ The Medal of Honor is the nation’s highest military honor. It is presented by the President “in the name of Congress,” and is sometimes referred to as the Congressional Medal of Honor. 7 
+
+ Congress established the Medal of Honor during the Civil War to recognize soldiers who had distinguished themselves by their gallantry in action. It is the nation’s highest military honor, awarded for acts of valor that are “above and beyond the call of duty.” 8 
+
+ Recommendations for the Medal of Honor are generally made by the military commander or others present at the time of the act. These recommendations are reviewed by the Department of Defense, which makes the final determination on military awards. 9 
+
+ In addition to the prestige associated with the Medal of Honor, recipients receive additional courtesies and benefits, including a monthly pension of $1,712.94 and access to certain military benefits. 10 
+
+ For additional information, including recommendation procedures, see CRS Report 95-519, Medal of Honor: History and Issues , by Barbara Salazar Torreon. 
+
+ Presidential Medal of Freedom 
+
+ The Presidential Medal of Freedom is typically described as the highest civilian award of the United States government. It has been called the “civilian equivalent” of the Medal of Honor. 11 
+
+ President Harry S. Truman first created the Medal of Freedom to reward war-connected acts or services performed by civilians during World War II. 12 It was renamed and broadened by 
+
+ 
+
+ 6 In recent years, most Congressional Gold Medal statutes authorize the U.S. Mint to strike bronze duplicates for sale to the general public. For information on duplicate medals, see CRS In Focus IF10934, Duplicate Congressional Gold Medals: Frequently Asked Questions , by Jacob R. Straus. 
+
+ 7 Congressional Medal of Honor Society, Statistics and FAQs , at https://www.cmohs.org/medal/faqs. 
+
+ 8 10 U.S.C. §9271. 
+
+ 9 Department of Defense Manual 1348.33, Volume 1, Manual of Military Decorations and Awards: Medal of Honor , May 7, 2021, at https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/134833_Vol1.PDF. 
+
+ 10 See 38 C.F.R. §3.802 for information on benefits, and see https://www.va.gov/disability/compensation-rates/special- benefit-allowance-rates/ for the Medal of Honor pension rate as of December 1, 2024. 
+
+ 11 “Presidential Medal of Freedom” in The Presidency A to Z , 5th ed., eds. Gerhard Peters and John T. Woolley (Thousand Oaks, CA: CQ Press, 2013), pp. 451-452. 
+
+ 12 Executive Order 9586, “The Medal of Freedom,” 10 Federal Register 8523, July 6, 1945. 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 3 
+
+ President John F. Kennedy in 1963 to recognize “any person who has made an especially meritorious contribution to (1) the security or national interests of the United States, or (2) world peace, or (3) cultural or other significant public or private endeavors.” 13 There are two degrees of the Medal, the higher being the Presidential Medal of Freedom with distinction. 
+
+ The President has wide discretion to bestow the medal on “any person recommended to the President for award of the Medal or any person selected by the President upon his own initiative.” 14 As such, recipients tend to reflect the personal and political interests of the President. The accomplishments of past recipients have been in wide-ranging fields, including public service, journalism, business, sports, and entertainment. 15 
+
+ The award is generally presented by the President at a White House ceremony. It may be awarded posthumously and to non-U.S. citizens. 
+
+ There is no formal nomination and selection procedure, 16 but letters making recommendations may be sent to the President. 
+
+ For additional information including a full list of Presidential Medal of Freedom recipients, see CRS Report R47639, Presidential Medal of Freedom , by Ben Leubsdorf. 
+
+ Presidential Citizens Medal 
+
+ In 1969, President Richard M. Nixon created the Presidential Citizens Medal “for the purpose of recognizing citizens of the United States of America who have performed exemplary deeds of service for their country or their fellow citizens.” 17 It is generally described as the second-highest civilian award of the U.S. government. 18 
+
+ The Presidential Citizens Medal “may be bestowed by the President upon any citizen of the United States at the sole discretion of the President,” and it can be awarded posthumously. 19 Recent recipients at White House ceremonies have included activists, athletes, disaster 
+
+ 
+
+ 13 Executive Order 11085, “The Presidential Medal of Freedom,” 28 Federal Register 1759, February 22, 1963. 
+
+ 14 Executive Order 11515, “Terminating Certain Bodies Established by the President,” 35 Federal Register 4543, March 13, 1970. 
+
+ 15 See Bruce Wetterau, The Presidential Medal of Freedom: Winners and Their Achievements (Washington: Congressional Quarterly Inc., 1996), and Lawrence M. Watson, The Presidential Medal of Freedom (Claymont, DE: Orders and Medals Society of America, 2014). 
+
+ 16 Juliet Eilperin, “One of the Last Washington Mysteries: How to Get the Medal of Freedom,” The Washington Post , November 23, 2015, at https://www.washingtonpost.com/politics/one-of-the-last-washington-mysteries-how-to-get-the- medal-of-freedom/2015/11/23/d3351fa2-91f3-11e5-b5e4-279b4501e8a6_story.html. 
+
+ 17 Executive Order 11494, “Establishing the Presidential Citizens Medal,” 34 Federal Register 18291, November 13, 1969. 
+
+ 18 See, for example, Kelly Hooper, “Biden to Award Presidential Citizens Medal to Several Jan. 6 Heroes,” Politico , January 5, 2023, at https://www.politico.com/news/2023/01/05/biden-awards-presidential-citizens-medal-to-several- jan-6-heroes-00076550; White House, “Remarks by President Trump at the Presentation of the Presidential Medal of Freedom to Dan Gable,” press release, December 7, 2020, https://trumpwhitehouse.archives.gov/briefings- statements/remarks-president-trump-presentation-presidential-medal-freedom-dan-gable; Charles J. Lewis and Stewart M. Powell, “Obama Presents Medals For Slain Sandy Hook Educators,” Connecticut Post , February 15, 2013, at https://www.ctpost.com/local/article/Obama-presents-medals-for-slain-Sandy-Hook-4283610.php; and White House, Office of the Press Secretary, “The President Participates in a Ceremony for 2008 Recipients of the Presidential Citizens Medal,” press release, December 10, 2008, at https://georgewbush- whitehouse.archives.gov/news/releases/2008/12/20081210-3.html. 
+
+ 19 E.O. 11494. 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 4 
+
+ responders, election workers, public officials, leaders of cultural institutions, police officers, teachers, and volunteers. 20 
+
+ As with the Presidential Medal of Freedom, recommendations for the Presidential Citizens Medal may be sent to the President. 
+
+ Additional Awards and Medals 
+
+ Table 1 contains information about selected medals and awards presented by or in the name of the President, as well as selected medals and awards established by Congress. It does not include military medals or awards. This is not a comprehensive list of all civilian honors awarded or authorized by the U.S. government. Resources listed in the “Additional Information” column generally contain details about the nomination and selection process for that award. 
+
+ Table 1. Selected National Medals and Awards 
+
+ Award or Medal Eligibility/Purpose Additional Information 
+
+ Alan T. Waterman Award 
+
+ “Younger scientists whose capabilities and accomplishments show exceptional promise of significant future achievement” (42 U.S.C. §1881a) 
+
+ https://new.nsf.gov/od/honorary-awards/ waterman 
+
+ Congressional Space Medal of Honor 
+
+ “Any astronaut who in the performance of the astronaut’s duties has distinguished himself or herself by exceptionally meritorious efforts and contributions to the welfare of the Nation and of humankind” (51 U.S.C. §30901) 
+
+ https://www.nasa.gov/history/congressio nal-space-medal-of-honor 
+
+ Enrico Fermi Award “Scientists, engineers, and science policymakers who have given unstintingly over their careers to advance energy science and technology” 
+
+ https://science.osti.gov/fermi 
+
+ Malcolm Baldrige National Quality Award 
+
+ “Companies and other organizations which ... have substantially benefited the economic or social well-being of the United States through improvements in the quality of their goods or services resulting from the effective practice of quality management” (15 U.S.C. §3711a) 
+
+ https://www.nist.gov/baldrige 
+
+ National Humanities Medal 
+
+ “Individuals and organizations whose work has deepened our nation’s understanding of and engagement with history, literature, languages, philosophy, and other humanities subjects” 
+
+ https://www.neh.gov/about/awards/ national-humanities-medals-nominations 
+
+ National Medal for Museum and Library Service 
+
+ “Outstanding libraries and museums that have made significant contributions in service to their communities” (20 U.S.C. §9107) 
+
+ https://www.imls.gov/grants/available/ national-medal-museum-and-library- service 
+
+ 
+
+ 20 U.S. President (Biden), “Remarks on Presenting the Presidential Citizens Medal,” Daily Compilation of Presidential Documents (January 6, 2023); U.S. President (Trump), “Remarks on Presenting the Presidential Citizens Medal to C. Richard Rescorla,” Daily Compilation of Presidential Documents (November 7, 2019); U.S. President (Obama), “Remarks on Presenting the Presidential Citizens Medals,” Daily Compilation of Presidential Documents (February 15, 2013); U.S. President (Obama), “Remarks on Presenting the Presidential Citizens Medals,” Daily Compilation of Presidential Documents (October 20, 2011); U.S. President (G.W. Bush), “Remarks on Presenting the Presidential Citizens Medals,” Weekly Compilation of Presidential Documents , vol. 44 (November 17, 2008), pp. 1428-1429; U.S. President (Clinton), “Remarks on Presenting the Presidential Citizens Medal,” Weekly Compilation of Presidential Documents , vol. 37 (January 8, 2001), pp. 41-49. 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 5 
+
+ Award or Medal Eligibility/Purpose Additional Information 
+
+ National Medal of Arts 
+
+ “Individuals or groups ... deserving of special recognition by reason of their outstanding contributions to the excellence, growth, support, and availability of the arts in the United States” (20 U.S.C. §955b) 
+
+ https://www.arts.gov/honors/medals 
+
+ National Medal of Science 
+
+ “Individuals ... deserving of special recognition by reason of their outstanding contributions to knowledge in the physical, biological, mathematical, engineering, behavioral or social sciences” (42 U.S.C. §1881) 
+
+ https://new.nsf.gov/od/honorary-awards/ national-medal-of-science 
+
+ National Security Medal 
+
+ “Any person ... for distinguished achievement or outstanding contribution made on or after July 26, 1947, in the field of national security through either exceptionally meritorious service performed in a position of high responsibility or through an act of heroism requiring personal courage of a high degree and complete disregard of personal safety” (E.O. 13709, October 2, 2015) 
+
+ Executive Order 10431 (January 19, 1953), as amended by Executive Order 13709 (October 2, 2015). 
+
+ National Medal of Technology and Innovation 
+
+ “Individuals or companies ... deserving of special recognition by reason of their outstanding contributions to the promotion of technology or technological manpower for the improvement of the economic, environmental, or social well-being of the United States” (15 U.S.C. §3711) 
+
+ https://www.uspto.gov/learning-and- resources/ip-programs-and-awards/ national-medal-technology-and- innovation-nmti 
+
+ President’s Environmental Youth Award 
+
+ “Outstanding environmental stewardship projects developed by K-12 youth” 
+
+ https://www.epa.gov/education/ presidents-environmental-youth-award 
+
+ President’s Volunteer Service Award 
+
+ “Individuals whose service positively impacts communities in every corner of the nation and inspires those around them to take action, too” 
+
+ https://presidentialserviceawards.gov 
+
+ Presidential Awards for Excellence in Mathematics and Science Teaching 
+
+ “The highest honors bestowed by the United States government specifically for K-12 science, technology, engineering, and mathematics teaching” 
+
+ https://paemst.nsf.gov 
+
+ Presidential Early Career Award for Scientists and Engineers 
+
+ “Outstanding scientists and engineers beginning their independent careers” 
+
+ https://new.nsf.gov/od/honorary-awards/ pecase 
+
+ Presidential Rank Award 
+
+ Career appointees who demonstrate “sustained accomplishment” or “sustained extraordinary accomplishment” (5 U.S.C. §4507) 
+
+ https://www.opm.gov/policy-data- oversight/senior-executive-service/ presidential-rank-awards 
+
+ Presidential Scholars Program 
+
+ “Persons who have recently been graduated, or are about to be graduated, from secondary schools, public or private ... chosen on the basis of their outstanding scholarship” (E.O. 11155, May 23, 1964) 
+
+ https://www.ed.gov/grants-and- programs/recognition-programs/us- presidential-scholars-program 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service 6 
+
+ Award or Medal Eligibility/Purpose Additional Information 
+
+ President’s “E” and “E Star” Awards 
+
+ “Persons, firms, and organizations engaged in the marketing of products who make significant contributions to the expansion of the export trade of the United States” (E.O. 10978, December 5, 1961) 
+
+ https://www.commerce.gov/tags/e- awards 
+
+ President’s Award for Distinguished Federal Civilian Service 
+
+ “Civilian officers or employees of the Federal Government for the best achievements having current impact in improving Government operations or serving the public interest” (E.O. 10717, June 27, 1957) 
+
+ https://www.opm.gov/policy-data- oversight/performance-management/ performance-management-cycle/ rewarding/the-presidents-award-for- distinguished-federal-civilian-service 
+
+ President’s Education Awards 
+
+ “Honors graduating elementary, middle and high school students for their achievement and hard work” 
+
+ https://www.ed.gov/grants-and- programs/recognition- programs/presidents-education-awards- program 
+
+ Public Safety Officer Medal of Valor 
+
+ “A public safety officer who is cited by the Attorney General, upon the recommendation of the Medal of Valor Review Board, for extraordinary valor above and beyond the call of duty” (42 U.S.C. §15201) 
+
+ https://bja.ojp.gov/program/medalofvalor 
+
+ Sources: United States Code , Codification of Presidential Proclamations and Executive Orders , Daily Compilation of Presidential Documents , agency websites. Notes: “Eligibility/Purpose” text comes from the website listed under “Additional Information” if not cited to a section of the U.S. Code or an executive order. Note that this table excludes military decorations and is not a comprehensive list of U.S. government civilian awards. 
+
+ Related CRS Resources 
+
+ CRS Report R43539, Commemorations in Congress: Options for Honoring Individuals, Groups, and Events , coordinated by Jacob R. Straus. 
+
+ CRS Report R45101, Congressional Gold Medals: Background, Legislative Process, and Issues for Congress , by Jacob R. Straus. 
+
+ CRS In Focus IF12085, Congressional Gold Medals: Categorization of Proposed and Enacted Medals, 1973-2020 , by Jacob R. Straus and Jared C. Nagel. 
+
+ CRS In Focus IF10934, Duplicate Congressional Gold Medals: Frequently Asked Questions , by Jacob R. Straus. 
+
+ CRS Report 95-519, Medal of Honor: History and Issues , by Barbara Salazar Torreon. 
+
+ CRS Report RS21282, Military Service Records, Awards, and Unit Histories: A Guide to Locating Sources , by Barbara Salazar Torreon and Travis A. Ferrell. 
+
+ CRS Report R47639, Presidential Medal of Freedom , by Ben Leubsdorf. 
+
+ CRS Report R42704, The Purple Heart: Background and Issues for Congress , by Barbara Salazar Torreon and Carly A. Miller. 
+
+ 
+
+ 
+
+ 
+ A Guide to Major Congressional and Presidential Awards 
+
+ 
+
+ Congressional Research Service R47020 · VERSION 8 · UPDATED 7 
+
+ 
+
+ Author Information 
+
+ Barbara Salazar Torreon Senior Research Librarian 
+
+ Ben Leubsdorf 
+
+ Research Librarian 
+
+ 
+
+ 
+
+ Disclaimer 
+
+ This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you wish to copy or otherwise use copyrighted material.
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+Israel: Background and U.S. Relations 
+
+June 15, 2022 
+
+Since Israel’s founding in 1948, successive U.S. Presidents and many Members of 
+Congress have demonstrated a commitment to Israel’s security and to close U.S.-Israel 
+
+ Jim Zanotti 
+
+cooperation. Strong bilateral ties influence U.S. policy in the Middle East, and Congress 
+
+Specialist in Middle 
+
+provides active oversight of the executive branch’s actions. Israel is a leading recipient 
+
+Eastern Affairs 
+
+of U.S. foreign aid and a frequent purchaser of major U.S. weapons systems. The two 
+
+ 
+
+countries signed a free trade agreement in 1985, and the United States is Israel’s largest 
+
+ 
+
+trading partner. Legislation in Congress frequently includes proposals to strengthen 
+U.S.-Israel cooperation. 
+
+Israel has a robust economy and an active democracy. The current power-sharing government came to power in 
+June 2021 and includes eight parties from across the political spectrum, including the first-ever instance of an 
+Arab-led party in the governing coalition. Prime Minister Naftali Bennett of the Yamina party and Foreign 
+Minister Yair Lapid of the Yesh Atid party lead the coalition, which has been struggling to survive since losing 
+majority support in Israel’s Knesset (parliament) in April 2022. Under the power-sharing agreement, Lapid could 
+become a caretaker prime minister if the Knesset votes to hold new elections. Benjamin Netanyahu of the Likud 
+party, who led Israel from 2009 to 2021 (and during an earlier stint in the 1990s) heads the opposition, and is on 
+trial for allegations of criminal corruption. Domestic debates in Israel have centered on policies regarding the 
+Palestinians and Israel’s Arab citizens, as well as issues regarding the economy, religion, and the judiciary’s role. 
+
+Israel’s political impasse with the Palestinians continues. Biden Administration officials have said that they seek 
+to preserve the viability of a negotiated two-state solution to the Israeli-Palestinian conflict, while playing down 
+near-term prospects for direct Israeli-Palestinian negotiations. Israel has militarily occupied the West Bank since 
+the 1967 Arab-Israeli war, with the Palestinian Authority exercising limited self-rule in some areas since the mid-
+1990s. The Sunni Islamist group Hamas (which the United States has designated as a terrorist organization) has 
+controlled the Gaza Strip since 2007, and has clashed at times with Israel from there while also supporting unrest 
+and violence elsewhere in the Israeli-Palestinian arena. Jerusalem and its holy sites continue to be a flashpoint, 
+and the Trump Administration controversially recognized Jerusalem as Israel’s capital and moved the U.S. 
+embassy there. In March 2022, Congress enacted legislation providing $1 billion in supplemental funding for the 
+Iron Dome anti-rocket system after Israel heavily relied on Iron Dome during a May 2021 Gaza conflict. Israel 
+may face challenges in improving difficult living conditions for Palestinians in the West Bank and Gaza while 
+ensuring its own security. Concerns about both points have shaped some debates in Congress about how Israel 
+uses U.S. aid. Approximately 660,000 Israelis live in residential neighborhoods or “settlements” in the West Bank 
+and East Jerusalem. These settlements are of disputed legality under international law. 
+
+Concerns about Iran strongly affect Israel’s strategic calculations. The Israeli government has previously sought to 
+influence U.S. policy on Iran’s nuclear program, and its officials have varying views about a possible U.S. return 
+to the 2015 international agreement. Meanwhile, Israel has made common cause with some Arab states to counter 
+Iran’s regional activities. Israeli observers who anticipate the possibility of a future war similar in magnitude to 
+Israel’s 2006 war against Iran’s ally Lebanese Hezbollah refer to skirmishes and covert actions since then 
+involving Israel, Iran, and Iran’s allies as “the campaign between the wars.” A threat along Israel’s northern 
+border persists from Hezbollah’s rocket arsenal and Iran-backed efforts to use Syrian bases and territory to bolster 
+Hezbollah. 
+
+Growing Israeli cooperation with some Arab and Muslim-majority states led to the Abraham Accords: U.S.-
+brokered agreements in 2020 and 2021 to normalize or improve Israel’s relations with the United Arab Emirates 
+(UAE), Bahrain, Morocco, and Sudan. Palestinian leaders decry Arab normalization with Israel that happens 
+before Palestinian national demands are met, and the Biden Administration has stated it wants further Israeli-Arab 
+state normalization to occur alongside progress on Israeli-Palestinian diplomacy. 
+
+U.S. officials regularly engage with Israeli interlocutors regarding their concerns about China and Russia 
+(including Russia’s invasion of Ukraine). Israel seeks to address these concerns while expanding economic 
+relations with China and avoiding Russian disruptions to Israeli military operations in Syria. 
+
+Congressional Research Service 
+
+ 
+
+ 
+ link to page 5 link to page 7 link to page 7 link to page 9 link to page 11 link to page 11 link to page 12 link to page 13 link to page 14 link to page 14 link to page 15 link to page 15 link to page 17 link to page 17 link to page 19 link to page 21 link to page 21 link to page 24 link to page 25 link to page 26 link to page 27 link to page 31 link to page 31 link to page 34 link to page 35 link to page 36 link to page 36 link to page 36 link to page 38 link to page 38 link to page 39 link to page 39 link to page 39 link to page 43 link to page 44 link to page 45 link to page 5 link to page 22 link to page 23 link to page 29 link to page 30 Israel: Background and U.S. Relations 
+
+ 
+
+ Contents 
+
+ Overview ......................................................................................................................................... 1 
+ Country Background ....................................................................................................................... 3 
+
+ Government and Politics ........................................................................................................... 3 
+
+ Current Government and Its Uncertain Future ................................................................... 5 
+ Major Domestic Issues ........................................................................................................ 7 
+
+ Arab Citizens of Israel .................................................................................................. 7 
+ Other Issues .................................................................................................................. 8 
+
+ Economy ................................................................................................................................... 9 
+ Military and Security Profile ................................................................................................... 10 
+
+ General Overview ............................................................................................................. 10 
+ Presumed Nuclear Capability ............................................................................................ 11 
+
+ U.S.-Israel Security Cooperation .................................................................................................... 11 
+ Israeli-Palestinian Issues and U.S. Policy ..................................................................................... 13 
+
+ Overview of Disputes and Diplomatic Efforts ........................................................................ 13 
+ The Biden Administration: Diplomacy and Human Rights Considerations ........................... 15 
+ Settlements .............................................................................................................................. 17 
+
+ Overview ........................................................................................................................... 17 
+ Implications ...................................................................................................................... 20 
+ U.S. Policy ........................................................................................................................ 21 
+
+ Jerusalem ................................................................................................................................. 22 
+
+ East Jerusalem Controversies ........................................................................................... 23 
+ The “Status Quo”: Jews and Muslims at the Temple Mount/Haram al Sharif .................. 27 
+
+ Background ................................................................................................................. 27 
+ Tensions in 2021 and 2022 ......................................................................................... 30 
+
+ Reopening of U.S. Consulate in Jerusalem? ..................................................................... 31 
+
+ Regional Threats and Relationships .............................................................................................. 32 
+
+ Countering Iran ....................................................................................................................... 32 
+
+ Iranian Nuclear Issue and Regional Tensions ................................................................... 32 
+ Syria .................................................................................................................................. 34 
+Hezbollah in Lebanon ....................................................................................................... 34 
+ Palestinian Militants and Gaza .......................................................................................... 35 
+
+ Arab States .............................................................................................................................. 35 
+
+ The Abraham Accords....................................................................................................... 35 
+ Arab-Israeli Regional Energy Cooperation ....................................................................... 39 
+
+ Turkey ..................................................................................................................................... 40 
+
+ China: Investments in Israel and U.S. Concerns ........................................................................... 41 
+
+ 
+
+ Figures 
+ Figure 1. Israel: Map and Basic Facts ............................................................................................. 1 
+ Figure 2. Population of Israeli West Bank Settlements ................................................................. 18 
+ Figure 3. Map of West Bank .......................................................................................................... 19 
+ Figure 4. Greater Jerusalem ........................................................................................................... 25 
+ Figure 5. Jerusalem: Key Sites in Context .................................................................................... 26 
+
+Congressional Research Service 
+
+ 
+ link to page 32 link to page 52 link to page 9 link to page 15 link to page 21 link to page 47 link to page 49 link to page 52 link to page 54 link to page 54 Israel: Background and U.S. Relations 
+
+ 
+
+ Figure 6. Old City of Jerusalem .................................................................................................... 28 
+ 
+
+ Figure C-1. Map of the Golan Heights .......................................................................................... 48 
+
+ 
+
+ Tables 
+ Table 1. Israeli Power-Sharing Government: Key Positions ........................................................... 5 
+ Table 2. Security Forces in Israel ................................................................................................... 11 
+ Table 3. Jewish Population in Specific Areas ................................................................................ 17 
+ 
+
+ Appendixes 
+ Appendix A. Historical Background ............................................................................................. 43 
+ Appendix B. Israeli Knesset Parties and Their Leaders ................................................................ 45 
+ Appendix C. Golan Heights .......................................................................................................... 48 
+ Appendix D. Examples of U.S.-Based, Israel-Focused Organizations ......................................... 50 
+
+ 
+
+ Contacts 
+ Author Information ........................................................................................................................ 50 
+ 
+
+Congressional Research Service 
+
+ 
+ link to page 5 link to page 5 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Overview 
+ U.S.-Israel defense, diplomatic, and economic cooperation has been close for decades, based on 
+common democratic values, religious affinities, and security interests. On May 14, 1948, the 
+United States was the first country to extend de facto recognition to the state of Israel (se e Figure 
+1 ) . Subsequently, relations have evolved through legislation, bilateral agreements, and trade. 
+
+ Figure 1. Israel: Map and Basic Facts 
+
+ 
+
+ Sources: Graphic created by CRS. Map boundaries and information generated using Department of State 
+Boundaries (2017); Esri (2013); the National Geospatial-Intelligence Agency GeoNames Database (2015); 
+DeLorme (2014). Fact information from International Monetary Fund, World Economic Outlook Database; CIA, 
+ The World Factbook ; and Economist Intelligence Unit. All numbers are estimates for 2022 unless otherwise 
+specified. 
+ Notes: According to the U.S. executive branch: (1) The West Bank is Israeli occupied with current status 
+subject to the 1995 Israeli-Palestinian Interim Agreement; permanent status to be determined through further 
+negotiation. (2) The status of the Gaza Strip is a final status issue to be resolved through negotiations. (3) The 
+United States recognized Jerusalem as Israel’s capital in 2017 without taking a position on the specific boundaries 
+of Israeli sovereignty. (4) Boundary representation is not necessarily authoritative. Additionally, the United States 
+recognized the Golan Heights as part of Israel in 2019; however, U.N. Security Council Resolution 497, adopted 
+on December 17, 1981, held that the area of the Golan Heights control ed by Israel’s military is occupied 
+territory belonging to Syria. The current U.S. executive branch map of Israel is available at https://www.cia.gov/
+the-world-factbook/countries/israel/map. 
+
+U.S. officials and lawmakers often consider Israel’s security as they make policy choices in the 
+Middle East. Congress regularly enacts legislation to provide military assistance to Israel and 
+
+Congressional Research Service 
+
+ 
+
+1 
+
+ 
+ link to page 39 link to page 15 link to page 15 link to page 36 Israel: Background and U.S. Relations 
+
+ 
+
+explicitly support its security. Such support is part of a regional security order—based heavily on 
+U.S. arms sales to Israel and Arab countries—that has avoided major Arab-Israeli interstate 
+conflict for nearly 50 years. Israel has provided benefits to the United States by sharing 
+intelligence, military technology, and other innovations. 
+
+While Israel is the largest regular annual recipient of U.S. military aid, some Members of 
+Congress have sought greater scrutiny of some of Israel’s actions. Some U.S. lawmakers express 
+concern about Israel’s use of U.S. military assistance against Palestinians, in light of entrenched 
+Israeli control in the West Bank and around the Gaza Strip, and diminished prospects for a 
+negotiated Israeli-Palestinian two-state solution. A few seek oversight measures and legislation to 
+distinguish certain Israeli actions in the West Bank and Gaza from general U.S. support for Israeli 
+security.1 
+
+Since U.S. aid to Israel significantly increased in the 1970s in connection with Israel’s peace 
+treaty with Egypt, developments in international trade have impacted Israel’s relations with the 
+United States and other global actors. During that time, Israel’s economy has gone from that of a 
+developing nation to one integrated into and on par with economies in Western countries, fueled 
+by a booming high-tech industry and other scientific fields that attract worldwide investment and 
+trade. Leveraging its military power, arms export capacity, and economic and technical strengths, 
+Israel has deepened its relations with India and China as well as other countries in Asia, Africa, 
+and Latin America. 
+
+After the Cold War ended, the Middle East became more central to U.S. policy, especially after 
+the September 11, 2001, Al Qaeda terrorist attacks on the U.S. homeland. Consequently, U.S.-
+Israel ties focused more on regional challenges—including those from various terrorist groups 
+and Iran. Some changes in U.S. military posture and political emphasis in the region could affect 
+Israeli assessments regarding the need for action independent from the United States. The United 
+States helped Israel negotiate the Abraham Accords in 2020 and 2021 to normalize or improve 
+Israel’s relations with various Arab and Muslim-majority states (see “The Abraham Accords”) , 
+and Israel has taken some steps without direct U.S. involvement to strengthen relations with other 
+Abraham Accords states such as the United Arab Emirates (UAE). Within this context, President 
+Biden has reemphasized the longtime U.S. commitment to Israel’s security (see “U.S.-Israel 
+Security Cooperation”) . 
+
+Iran continues to be a top Israeli security concern (see “Countering Iran”) . Israel has sought to 
+influence U.S. policy on Iran, including the approach to Iran’s nuclear program and deterrence of 
+Iran-backed actors in Syria, Lebanon, Iraq, the Gaza Strip, and Yemen. Israeli officials welcomed 
+the U.S. withdrawal in 2018 from the international agreement on Iran’s nuclear program (known 
+as the Joint Comprehensive Plan of Action, or JCPOA) and accompanying reimposition of U.S. 
+sanctions on Iran’s core economic sectors. They seek to coordinate with U.S. counterparts on 
+future action to prevent Iranian progress toward a nuclear weapon, whether or not the United 
+States reenters the JCPOA or negotiates a separate international agreement. Low-level Israel-Iran 
+conflict and covert rivalry persists in various settings—Iran itself, countries bordering Israel, 
+cyberspace, and international waters. 
+
+In the Israeli-Palestinian conflict, political disputes persist over key issues including security 
+parameters, Israel-West Bank borders, Jewish settlements, Palestinian refugees, and the status of 
+
+ 
+1 Rebecca Kheel, “Progressives ramp up scrutiny of US funding for Israel,” The Hill , May 23, 2021. One bill, the Two-
+State Solution Act (H.R. 5344), would expressly prohibit U.S. assistance (including defense articles or services) to 
+further, aid, or support unilateral efforts to annex or exercise permanent control over any part of the West Bank 
+(including East Jerusalem) or Gaza. 
+
+Congressional Research Service 
+
+ 
+
+2 
+
+ 
+ link to page 17 link to page 45 link to page 38 Israel: Background and U.S. Relations 
+
+ 
+
+Jerusalem (see “Israeli-Palestinian Issues and U.S. Policy”) . Polls suggest widespread skepticism 
+among the Israeli public about prospects for a negotiated end to the conflict.2 This skepticism 
+fuels speculation and debate about Israeli alternatives such as indefinitely controlling or annexing 
+West Bank areas, improving Palestinian living conditions and economic prospects to reduce 
+tensions, or focusing more on building relations with Arab states. 
+
+Israel seeks to balance various considerations regarding China and Russia. Its leaders have taken 
+some steps to address U.S. concerns regarding China’s possible misuse of Israeli technology or 
+access to Israeli infrastructure (see “China: Investments in Israel and U.S. Concerns”) , and 
+Russia’s invasion of Ukraine (see text box below). Yet, many leading Israeli government and 
+business figures also favor maintaining a strong economic relationship with China, and Israeli 
+security decisionmakers have an interest in avoiding Russian disruptions to Israel’s ability to act 
+militarily in Syria. 
+
+ Russia’s Invasion of Ukraine 
+
+The Israeli government has publicly condemned Russia’s 2022 invasion of Ukraine through statements and votes in 
+international fora. Meanwhile, it has sought to provide political support for Ukraine and humanitarian relief for 
+Ukrainians—including allowing over 15,000 Jewish and non-Jewish refugees to enter Israel—without alienating 
+Russia.3 About 1.2 mil ion (around 15%) of Israel’s population are Russian speakers with family origins in the 
+former Soviet Union.4 
+Since 2015, Russia’s military presence and air defense capabilities in Syria have given it influence over Israel’s ability 
+to conduct airstrikes there (see “Syria”) . Israel has used access to Syrian airspace to target Iranian personnel and 
+equipment, especially those related to the transport of munitions or precision-weapons technology to Iran’s ally 
+Hezbol ah in Lebanon.5 To date, Israel has refrained from providing lethal assistance to Ukraine or approving 
+third-party transfers of weapons with proprietary Israeli technology.6 Under some Western pressure, Israel has 
+contemplated providing defensive equipment, personal combat gear, and/or warning systems to Ukraine’s military, 
+partly to project to existing arms export clients that it would be a reliable supplier in crisis situations.7 Israel 
+announced an initial shipment of helmets and flak jackets to Ukrainian rescue forces and civilian organizations in 
+May 2022.8 
+
+ Country Background 
+
+ Government and Politics 
+ Israel is a parliamentary democracy in which the prime minister is head of government (see text 
+box below for more information) and the president is a largely ceremonial head of state. The 
+unicameral parliament (the Knesset) elects a president for a seven-year term. The current 
+
+ 
+2 See, e.g., Tamar Hermann and Or Anabi, “What Solutions to the Conflict with the Palestinians are Acceptable to 
+Israelis?” Israel Democracy Institute, August 3, 2021. 
+
+3 Isabel Kershner, “Israelis Debate How Many, and What Kind of, Refugees to Accept,” New York Times , March 24, 
+2022. 
+
+4 Lilly Galili, “Russia-Ukraine war: For Israel's Russian speakers conflict is painful and personal,” Middle East Eye , 
+February 25, 2022. 
+
+5 Zev Chafets, “Why Israel Won’t Supply the Iron Dome to Ukraine,” Bloomberg , March 11, 2022. 
+6 Barak Ravid, “Scoop: Israel rejects U.S. request to approve missile transfer to Ukraine,” Axios , May 25, 2022. 
+7 Yaniv Kubovich and Jonathan Lis, “Israeli Officials Inclined to Increase Ukraine Aid in Face of Russian Atrocities,” 
+haaretz.com, May 3, 2022; Anna Ahronheim, “Israel to increase military, civilian aid to Ukraine – report,” jpost.com, 
+May 4, 2022. 
+
+8 “In first, Israel sends 2,000 helmets, 500 flak jackets to Ukraine,” Times of Israel , May 18, 2022. 
+
+Congressional Research Service 
+
+ 
+
+3 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+president, Isaac Herzog, took office in July 2021. Israel does not have a written constitution. 
+Instead, Basic Laws lay down the rules of government and enumerate fundamental rights. Israel 
+has an independent judiciary, with a system of magistrates’ courts and district courts headed by a 
+Supreme Court. 
+
+The political spectrum is highly fragmented, with small parties exercising disproportionate power 
+due to the relatively low vote threshold for entry into the Knesset (3.25%), and larger parties 
+needing small-party support to form and maintain coalition governments. In 2014, however, the 
+Knesset tightened the conditions for bringing down a government through a dispersal or no-
+confidence vote.9 
+
+ Primer on Israeli Electoral Process and Government-Building 
+
+Elections to Israel’s 120-seat Knesset are direct and proportional based on a party list system, with the entire 
+country constituting a single electoral district. Al Israeli citizens age 18 and older may vote. Turnout in elections 
+since 2001 has ranged between 62% and 72% of registered voters (before that it generally ranged between 77% 
+and 80%). Elections must be held at least every four years, but are often held earlier due to difficulties in holding 
+coalitions together. A Central Elections Committee headed by a Supreme Court justice, with representatives from 
+parties in the Knesset, is responsible for conducting and supervising the elections. 
+National laws provide parameters for candidate eligibility, general elections, and party primaries—including specific 
+conditions and limitations on campaign contributions and public financing for parties.10 Since 2007, a “cooling-off 
+law” requires that senior Israeli military officers wait at least three years before entering civilian politics.11 
+Fol owing elections, Israel’s president gives the task of forming a government to the Knesset member the 
+president believes has the best chance to form a government as prime minister. The would-be prime minister has 
+28 days to assemble a coalition, and the president can extend this period for an additional 14 days, with provisions 
+allowing the president to authorize others to form a government if the initial selectee is unsuccessful in the task. 
+The government and its ministers are installed fol owing a successful vote of confidence in the Knesset. 
+Thereafter, the ministers determine the government’s course of action on domestic issues, while a “security 
+cabinet” (formally known as the Ministerial Committee on Defense) largely directs military and national security 
+actions. The security cabinet consists of a group of key ministers—some whose membership is set by law, others 
+who are appointed by the prime minister—who number no more than half of all cabinet ministers.12 
+Israel experienced a period of unprecedented political instability from April 2019 to June 2021. During that time, 
+Israel held four elections with then-Prime Minister Benjamin Netanyahu facing criminal prosecution on political 
+corruption charges. Although Israel’s president selected Netanyahu to form a government after both the April 
+2019 and September 2019 elections, he was unable to do so—the first two times such a stalemate had occurred in 
+Israel. After the March 2020 election, Netanyahu formed a power-sharing government in May 2020, but the 
+government col apsed later that year over a failure to pass a national budget. The resulting election in March 2021 
+led to the replacement of Netanyahu’s government by the current wide-ranging but fractious coalition of parties in 
+June 2021. 
+
+A number of factors distinguish Israel from the United States and other developed countries, 
+including the regional threats it faces, its unique historical experience, and its population’s 
+relatively higher level of direct military service.13 In Israel’s domestic politics, right-of-center 
+ 
+9 Knesset News, “Analysis: Israel’s new constructive vote of no-confidence,” March 18, 2014. 
+10 For additional details on Israel’s campaign finance laws, see Ruth Levush, “Campaign Finance: Israel,” Law Library 
+of Congress, July 25, 2012. 
+
+11 The law was reportedly intended to counter Israeli military officers’ cultivation of civilian political connections and 
+influence in anticipation of their possible career transitions. Gideon Alon, “Knesset Okays 3-year Cooling-off Period 
+for Security Officials,” haaretz.com, March 12, 2007. 
+
+12 See, e.g., Isabel Kershner, “Israeli Law Vesting War Power in 2 Top Leaders Faces Criticism,” New York Times , 
+May 3, 2018; Dan Williams, “Netanyahu’s new security cabinet may hesitate on any Iran war,” Reuters , March 19, 
+2013. 
+
+13 Military service remains compulsory for most Jewish Israeli young men and women, and most Jewish Israeli men 
+remain on reserve duty until the age of 40 (for soldiers) or 45 (for officers). 
+
+Congressional Research Service 
+
+ 
+
+4 
+
+ 
+ link to page 47 link to page 9 link to page 49 Israel: Background and U.S. Relations 
+
+ 
+
+parties skeptical of compromise with the Palestinians and influenced by religious nationalism 
+have supplanted the center-left, more secular Labor movement as the dominant force in the 
+country. See Appendix A for historical background. 
+
+ Current Government and Its Uncertain Future 
+
+A power-sharing government headed by Prime Minister Naftali Bennett (see the text box below 
+for a brief biography) took office in June 2021. This leadership change ended Benjamin 
+Netanyahu’s 12-year tenure as prime minister and two years of political turmoil following 
+Netanyahu’s February 2019 criminal indictment on corruption charges.14 Netanyahu and his 
+Likud party now lead the Knesset’s opposition, as was the case from 2006 to 2009. 
+
+While Bennett—a right-of-center figure who leads the Yamina party—currently heads the 
+government, the centrist Yesh Atid party leader Yair Lapid played a leading role in arranging the 
+coalition. If the government remains intact, Bennett would serve as prime minister until August 
+27, 2023, at which point Lapid would become prime minister. The government draws its support 
+from a disparate coalition of parties on the right (Yamina, New Hope, Yisrael Beitenu), center 
+(Yesh Atid and Kahol Lavan), and left (Labor, Meretz) of the political spectrum, as well as from 
+the Arab-led, Islamist United Arab List (UAL or Ra’am) (see Table 1 and Appendix B ) . UAL is 
+the first independent Arab party to join an Israeli government.15 Women make up approximately 
+one-third of Israel’s cabinet, with nine female ministers, more than in any previous government.16 
+
+Since forming, the coalition successfully passed a 2021-2022 budget that aims at reforms and 
+expansion in a number of Israel’s key socioeconomic sectors.17 Yet, the coalition’s members have 
+clashed regularly on issues regarding the Palestinians, Israel’s Arab minority, and religion within 
+the state.18 Because of differences within the government, coalition members have agreed not to 
+take comprehensive steps—through unilateral or diplomatic means—aimed at achieving final 
+territorial outcomes in the West Bank. The coalition’s divergent viewpoints contribute to 
+difficulties in building consensus on: 
+
+ How to strengthen Israel’s security and protect its Jewish character while 
+
+preserving rule of law and freedom of expression for all citizens. 
+
+ How to promote general economic strength while addressing popular concerns 
+
+regarding economic inequality and cost of living. 
+
+ Table 1. Israeli Power-Sharing Government: Key Positions 
+
+ Position 
+
+ Name 
+
+ Party 
+
+Prime Minister 
+
+Naftali Bennett 
+
+Yamina 
+
+Foreign Minister and 
+
+Yair Lapid 
+
+Yesh Atid 
+
+Alternate Prime Minister 
+
+Defense Minister 
+
+Benny Gantz 
+
+Kahol Lavan 
+
+Finance Minister 
+
+Avigdor Lieberman 
+
+Yisrael Beitenu 
+
+ 
+14 Netanyahu also served an earlier 1996-1999 term as prime minister. 
+15 Aaron Boxerman, “History made as Arab Israeli Ra’am party joins Bennett-Lapid coalition,” Times of Israel , June 3, 
+2021. 
+
+16 Mazal Mualem, “Israeli female ministers introduce reforms, shake up agenda,” Al-Monitor , September 10, 2021. 
+17 Ricky Ben-David, “How much of a revolution? 13 key reforms in Israel’s new state budget,” Times of Israel , 
+November 4, 2021. 
+
+18 Dov Lieber, “Israel’s Ruling Coalition Loses Majority,” Wall Street Journal , April 7, 2022. 
+
+Congressional Research Service 
+
+ 
+
+5 
+
+ 
+ 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Position 
+
+ Name 
+
+ Party 
+
+Justice Minister 
+
+Gideon Sa’ar 
+
+New Hope 
+
+Interior Minister 
+
+Ayelet Shaked 
+
+Yamina 
+
+Transportation Minister 
+
+Merav Michaeli 
+
+Labor 
+
+Public Security Minister 
+
+Omer Bar Lev 
+
+Labor 
+
+Health Minister 
+
+Nitzan Horowitz 
+
+Meretz 
+
+ 
+
+ Prime Minister Naftali Bennett: Biography 
+
+Bennett, born in 1972, is a leading figure of the Israeli national religious, pro-settler right. He 
+hails from a modern Orthodox Jewish background. Having parents who emigrated from the 
+United States, Bennett lived in America at multiple times as a youth and adult. He served in 
+various Israeli special forces units (and remains a reservist) before starting what became a 
+successful career as a software entrepreneur. 
+Entering politics in 2006, Bennett served as chief of staff for Binyamin Netanyahu until 2008, 
+while Netanyahu was serving as opposition leader in the Knesset. Later, Bennett served as 
+director-general of the Yesha Council (the umbrella organization for Israeli West Bank 
+
+settlers) from 2010 to 2012. 
+He then became the party leader for HaBayit HaYehudi (The Jewish Home) and led the party into the Knesset in 
+2013. In 2018, he left The Jewish Home, seeking various right-of-center electoral alliances before finally becoming 
+head of Yamina in 2020. Bennett has participated in several coalition governments led by Netanyahu, serving as 
+economy minister (2013-2015), education minister (2015-2019), and defense minister (2019-2020). In May 2020, 
+he led Yamina into the opposition when Netanyahu and Likud formed a power-sharing government with Benny 
+Gantz and Kahol Lavan. 
+Bennett openly opposes the creation of a Palestinian state, though he supports greater Palestinian autonomy in 
+West Bank urban areas. He favors continued expansion of Israeli settlements in the West Bank and the 
+annexation of Jewish-settled areas. However, he has agreed not to pursue annexation as prime minister in the 
+current power-sharing government. 
+On domestic issues, Bennett generally supports free-market policies, a modest government safety net, and a focus 
+on equality of opportunity and education for economically challenged Israelis. He has supported efforts in previous 
+governments to limit the power of the judiciary and other national institutions to check executive and legislative 
+actions.19 
+
+In April 2022, the power-sharing government weakened when coalition whip Idit Silman from 
+Yamina resigned from the coalition. She expressed concerns that the government’s actions had 
+harmed Jewish identity in Israel, and voiced support for an alternative, right-of-center 
+government. In June 2022, Nir Orbach from Yamina also left the coalition, pledging to work 
+toward an alternative coalition without initially voting to trigger new elections. 
+
+With the coalition’s support down to 59 out of 120 Knesset members, it faces difficulties in 
+surviving and functioning. If the Netanyahu-led opposition can garner majority support in a 
+Knesset vote, it can either form an alternative government or require new elections.20 The 
+following considerations could be relevant: 
+
+ To lead a new government, Netanyahu might need more coalition supporters to 
+
+switch sides, because the six Knesset members of the Arab-led Joint List from the 
+opposition are unlikely to support him. 
+
+ 
+19 Dahlia Scheindlin, “The Assault on Israel’s Judiciary,” The Century Foundation, July 7, 2021. 
+20 David Makovsky, “Political Tempest in Israel: Can Bennett Right the Ship?” Washington Institute for Near East 
+Policy, April 11, 2022. 
+
+Congressional Research Service 
+
+ 
+
+6 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Under the power-sharing agreement, a Knesset vote for new elections could lead 
+
+to Lapid taking over as caretaker prime minister until the formation of a 
+permanent government. 
+
+ A Knesset failure to pass a 2023-2024 budget by March 2023 would 
+
+automatically trigger new elections. 
+
+ Another figure (such as Defense Minister Benny Gantz) could conceivably try to 
+
+form a new government with support from current coalition and opposition 
+elements. 
+
+In June 2022, the Netanyahu-led opposition in the Knesset withheld its support for a bill to renew 
+the application of certain aspects of civilian law to Israeli settlers in the West Bank, and the bill—
+which is also opposed by some members of the coalition—failed to pass. The renewal is normally 
+a routine matter, but right-of-center members of the opposition refused to vote for it in hopes of 
+bringing down the coalition. Some observers speculate that stalemate on the settler law or other 
+triggers could lead Justice Minister Gideon Sa’ar (a former Likud member) to defect from the 
+coalition and form a government with Netanyahu, or lead the Knesset to vote for new elections.21 
+
+ Major Domestic Issues 
+
+In the context of the fractious coalition government that no longer enjoys majority Knesset 
+support, prospects are generally dim for legislating on key issues. Nevertheless, the following 
+subjects generate domestic debate in Israel. 
+
+ Arab Citizens of Israel 
+ While most Arabs living in Israel—many of whom identify as Palestinians—are citizens with the 
+right to vote and organize politically, they are largely segregated from Jewish communities.22 
+Their neighborhoods have comparatively higher levels of crime and lower levels of income, 
+education, and infrastructure and service provision. Arab Israelis were subject to martial law from 
+Israel’s founding in 1948 until 1966, and unlike their Jewish, Druze, or Circassian counterparts in 
+Israel, they do not have a compulsory military service requirement.23 Leading Arab political 
+figures strongly opposed Israel’s controversial 2018 Basic Law defining Israel as the national 
+homeland of the Jewish people,24 while observers have debated the law’s symbolism and 
+substance.25 
+
+Due partly to the influence of UAL leader Mansour Abbas within the current coalition, the 2021-
+2022 budget includes an agreement to allocate more than $10 billion over the next five years to 
+address Arab-Jewish disparities in Israel and other concerns Arabs face.26 Arab-led parties also 
+ 
+21 Rory Jones and Yardena Schwartz, “Israeli Coalition In Danger After Vote,” Wall Street Journal , June 7, 2022; 
+Mazal Mualem, “Israel’s Lapid courts Arab parties with eye toward early elections,” Al-Monitor , June 9, 2022. 
+22 Kali Robinson, “What to Know About the Arab Citizens of Israel,” Council on Foreign Relations, 
+23 Military service is required for Jewish men and women, and Druze and Circassian men. Law Library of Congress, 
+ Israel: Military Draft Law and Enforcement , November 2019. State Department, International Religious Freedom 
+Report for 2020, Israel, West Bank, and Gaza. 
+
+24 Text of law available at https://perma.cc/9PZN-DJGY. 
+25 Loveday Morris, “Deluge of opposition to Israel’s nation-state law builds with new court petition,” 
+washingtonpost.com, August 7, 2018. In a July 2021 ruling, Israel’s Supreme Court rejected petitions challenging the 
+Basic Law’s constitutionality. Ruth Levush, “Israel: Supreme Court Affirms Constitutionality of Basic Law: Israel – 
+Nation State of the Jewish People,” Global Legal Monitor, Law Library of Congress, October 4, 2021. 
+
+26 Afif Abu Much, “Arab-Israeli party celebrates budget passage,” Al-Monitor , November 8, 2021. 
+
+Congressional Research Service 
+
+ 
+
+7 
+
+ 
+ link to page 15 Israel: Background and U.S. Relations 
+
+ 
+
+side with Arab Bedouins who claim that the government does not properly account for the long-
+established Bedouin way of life by implementing land use policies seeking to uproot Bedouins 
+from villages not formally recognized under Israeli law in Israel’s southern Negev desert.27 
+
+Violent crime in largely Arab-populated cities has become an increasing concern. While it most 
+directly impacts Arab residents, unrest in these cities during the May 2021 Israel-Gaza conflict 
+demonstrated the potential for violence to affect Arab-Jewish interactions as well. The 
+government’s $10 billion funding plan for Arab issues includes $760 million toward security and 
+economic measures to deter criminals, while also addressing socioeconomic root causes. Yet, 
+some Arab leaders express skepticism that these measures can significantly stem the illegal 
+weapons trade that fuels crime.28 In October 2021, the government said that Israel’s military and 
+the Israel Security Agency (Shin Bet or Shabak) (se e Table 2 ) would participate in efforts to 
+reduce crime in Arab-populated areas. Arab Israeli leaders have publicly disagreed about 
+involving these national security branches, which are subject to less constraint and oversight than 
+the police.29 
+
+ Other Issues 
+
+ Relationship between religion and state. Secular and religious Jewish Israelis have 
+
+traditionally differed on how to apply Jewish religious law in various aspects of Israeli 
+society. A major issue for several years has been whether to require military conscription 
+for the majority of Haredim (ultra-Orthodox Jews) who claim exemptions for religious 
+study. A draft Knesset bill, if passed, would generally preserve exemptions for Haredim 
+who agree to vocational training.30 The government’s power-sharing agreement also 
+contemplates liberalizing state kashrut (kosher certification and supervision) and 
+conversion practices,31 with some kashrut reforms phasing in during 2022 as part of the 
+2021-2022 budget deal.32 Other proposals, such as providing access to civil marriage or 
+public transportation on the Sabbath, are unlikely to gain traction given the government’s 
+limited mandate. The coalition has not agreed to date on a compromise for a mixed-
+gender prayer space at the Western Wall plaza in Jerusalem’s Old City.33 
+
+ Judicial and other checks on majority rule. Many right-of-center political figures in 
+
+Israel have publicly bemoaned checks on popular opinion and majority rule, including in 
+connection with legal proceedings against former Prime Minister Netanyahu. During 
+Netanyahu’s time in office, his government proposed a law in 2018 to limit judicial 
+review over legislation.34 The current government has established a committee to draft a 
+Basic Law aimed at providing clearer constitutional guidance for Israel, including on 
+judicial review of laws and possible Knesset override authority. However, the fractious 
+
+ 
+27 Nati Yefet, “Arab Parties’ Fight for Political Control in Israel’s Negev Reaches Boiling Point,” haaretz.com, 
+February 16, 2022. 
+
+28 Danny Zaken, “Arab-Israeli city takes battle against violence into its own hands,” Al-Monitor , January 24, 2022. 
+29 Afif Abu Much, “Arab-Israelis split on Shin Bet’s role in fighting surging violence,” Al-Monitor , October 6, 2021; 
+Alex Lederman, “Betting on the Shin Bet,” Israel Policy Forum, October 20, 2021. 
+
+30 Knesset News, “Foreign Affairs and Defense Committee discusses Haredi draft bill ahead of final votes in the 
+Knesset Plenum,” February 9, 2022. 
+
+31 “What’s in the coalition agreements Yesh Atid signed with ‘change bloc’ partners,” Times of Israel , June 11, 2021. 
+32 Alan Rosenbaum, “Are Israel’s kashrut, conversion reforms moving forward?” jpost.com, April 14, 2022. 
+33 Judy Maltz, “Why the Western Wall Deal Still Isn’t Happening,” haaretz.com, December 9, 2021. 
+34 Jeffrey Heller, “Israeli Legislation Reining in Supreme Court Wins Preliminary Approval,” Reuters , May 6, 2018. 
+
+Congressional Research Service 
+
+ 
+
+8 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+coalition may be unlikely to enact such a potentially controversial and impactful law.35 
+Even absent new legislation, Justice Minister Sa’ar’s power to shape Israel’s justice 
+sector and influence personnel choices could move the judiciary rightward.36 
+
+ Economy 
+ Israel has an advanced industrial, market economy in which the government plays a substantial 
+role. Despite limited natural resources, the agricultural and industrial sectors are well developed. 
+The engine of the economy is an advanced high-tech sector, including aviation, communications, 
+computer-aided design and manufactures, medical electronics, and fiber optics. Israel still 
+benefits from loans, contributions, and capital investments from the Jewish diaspora, but 
+economic strength has lessened its dependence on external financing. 
+
+Aside from a moderate 2020 slump and robust 2021 recovery during the COVID-19 pandemic, 
+over the past five years Israel’s economy has shown steady growth (around 3-5% annually). 
+International Monetary Fund (IMF) growth projections remain in a similar range for the next five 
+years, with inflation and unemployment expectations remaining generally low.37 
+
+ Bilateral Trade 
+
+The United States is Israel’s largest single-country trading partner,38 and—according to 2021 data from the U.S. 
+Census Bureau and Bureau of Economic Analysis—Israel is the United States’s 24th-largest trading partner.39 The 
+two countries concluded a Free Trade Agreement (FTA) in 1985, eliminating all customs duties between the two 
+trading partners. The FTA includes provisions that protect both countries’ more sensitive agricultural sub-sectors 
+with nontariff barriers, including import bans, quotas, and fees. Qualifying Industrial Zones (QIZs) in Jordan and 
+Egypt are considered part of the U.S.-Israel free trade area.40 In 2021, Israel imported approximately $12.8 bil ion 
+in goods from and exported $18.7 bil ion in goods to the United States.41 The United States and Israel have 
+launched several programs to stimulate Israeli industrial and scientific research, for which Congress has authorized 
+and appropriated funds on several occasions.42 
+
+Although Israel’s overall macroeconomic profile and fiscal position appear favorable, its relative 
+poverty levels are the fifth highest within the 37-country Organisation of Economic Cooperation 
+and Development (OECD).43 Israeli Haredim (ultra-Orthodox Jews) and Arabs are particularly at 
+risk, with nearly half of both groups living in material poverty.44 
+
+ 
+35 Gila Stopler, “Basic Law Legislation: The Basic Law That Can Make or Break Israeli Constitutionalism,” 
+ConstitutionNet, August 16, 2021. 
+
+36 Yonah Jeremy Bob and Gil Hoffman, “Is Gideon Sa’ar Israel's most impactful minister?” jpost.com, October 7, 
+2021. 
+
+37 Based on data from the International Monetary Fund’s World Economic Outlook Database, April 2022. 
+38 According to the European Commission’s Directorate-General for Trade, for 2021 the countries of the European 
+Union accounted for 29.9% of Israel’s total trade volume, while the United States accounted for 16.4% and China 
+10.1%. Document available at https://webgate.ec.europa.eu/isdb_results/factsheets/country/details_israel_en.pdf. 
+
+39 Monthly U.S. International Trade in Goods and Services, December 2021, available at 
+https://www.census.gov/foreign-trade/Press-Release/ft900/ft900_2112.pdf. 
+
+40 See https://www.trade.gov/qualifying-industrial-zones. 
+41 Statistics compiled by Foreign Trade Division, U.S. Census Bureau, available at http://www.census.gov/foreign-
+trade/balance/c5081.html. 
+
+42 CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. 
+43 OECD Economic Surveys: Israel, September 2020. 
+44 Ibid. 
+
+Congressional Research Service 
+
+ 
+
+9 
+
+ 
+ link to page 15 Israel: Background and U.S. Relations 
+
+ 
+
+ Military and Security Profile 
+
+ General Overview 
+
+Israel maintains conventional military superiority relative to its neighbors and the Palestinians. 
+Shifts in regional order and evolving asymmetric threats have led Israel to update its efforts to 
+project military strength, deter attack, and defend its population and borders. Israel also has 
+developed advanced missile defense systems and reported cyber defense capabilities. 
+
+According to estimates from Janes , Israel’s military (see Table 2 for descriptions of various 
+Israeli security forces) features total active duty manpower across the army, navy, and air force of 
+approximately 180,000, plus 445,000 in reserve—numbers aided by mandatory conscription for 
+most young Jewish Israeli men and women, followed by extended reserve duty. Israel’s overall 
+annual defense budget is approximately $17.6 billion, constituting about 3.7% of its total gross 
+domestic product (GDP).45 
+
+Israel has a robust homeland security system featuring sophisticated early warning practices, 
+thorough border and airport security controls, and reinforced rooms or shelters engineered to 
+withstand explosions in most of the country’s buildings. Israel also has proposed and partially 
+constructed a national border fence network of steel barricades (accompanied at various points by 
+watch towers, patrol roads, intelligence centers, and military brigades) designed to minimize 
+militant infiltration, illegal immigration, and smuggling from Egypt, Syria, Lebanon, Jordan, and 
+the Gaza Strip.46 
+
+Some observers cited in State Department reporting on human rights characterize certain Israeli 
+security measures, including administrative detentions that affect many Palestinians, as violations 
+of human rights or due process norms.47 Israeli authorities justify administrative detention to 
+prevent imminent attacks or to detain suspects without releasing sensitive information,48 and the 
+practice is subject to Israeli legal standards.49 
+
+ 
+45 “Israel - Defence Budget,” Jane’s Defence Budgets , April 4, 2022. For purposes of comparison, IHS Jane’s reports 
+that the U.S. defense budget totals close to $759 billion annually, constituting approximately 3.3% of total GDP. The 
+World Bank, citing data from the Stockholm International Peace Research Institute, states the following figures for 
+defense spending as a percentage of GDP in other key Middle Eastern countries as of 2020: Egypt-1.2%, Iran-2.2%, 
+Iraq-4.1%, Jordan-5.0%, Lebanon-3.0%, Saudi Arabia-8.4%, Turkey-2.8%, United Arab Emirates-5.6%. 
+https://data.worldbank.org/indicator/MS.MIL.XPND.GD.ZS. 
+
+46 Judah Ari Gross, “‘A wall of iron, sensors and concrete’: IDF completes tunnel-busting Gaza barrier,” Times of 
+Israel , December 7, 2021; Gad Lior, “Cost of border fences, underground barrier, reaches NIS 6bn,” Ynetnews , January 
+30, 2018. 
+
+47 State Department, 2021 Country Report on Human Rights Practices: Israel, West Bank and Gaza. 
+48 “Israel weighs extending administrative detention of sick Palestinian teen,” Times of Israel , January 10, 2022. 
+49 State Department, 2021 Country Report on Human Rights Practices: Israel, West Bank and Gaza. 
+
+Congressional Research Service 
+
+ 
+
+10 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Table 2. Security Forces in Israel 
+
+ Unit 
+(and Supervising Ministry) Current Leader 
+
+ Key Sub-units (if applicable) 
+
+ Israel Defense Forces 
+
+Lieutenant General 
+
+ Ground forces (including Oz Brigade commando units – 
+
+(Defense Ministry) 
+
+Aviv Kochavi 
+
+Maglan, Duvdevan, and Egoz) 
+
+ Navy (including Shayetet 13 commando unit) 
+ Air force (including Shaldag commando unit) 
+ Intelligence directorate (Aman) (including Sayeret 
+
+Matkal commando unit) 
+
+ Unit 8200 (decryption and signals intelligence) 
+
+ Institute for Intelligence and 
+
+David Barnea 
+
+ 
+
+ Special Operations (Mossad) 
+ (Prime Ministry) 
+
+ Israel Security Agency 
+
+Ronen Bar 
+
+ Yamas (undercover counterterrorism unit formally part 
+
+ (Shin Bet or Shabak) 
+
+of border police but subordinate to Shin Bet) 
+
+(Prime Ministry) 
+
+ Israel Police 
+
+Kobi Shabtai 
+
+ Border police (Magav) 
+
+(Public Security Ministry) 
+
+o Regular units deployed at checkpoints and in rural 
+
+areas, the West Bank, and Jerusalem 
+
+o Yamam (special counterterrorism and rescue unit) 
+
+ Yasam (riot and crowd control unit) 
+
+ Israel Prison Service 
+
+Katy Perry 
+
+ 
+
+(Public Security Ministry) 
+
+ Presumed Nuclear Capability 
+
+Israel is not a party to the Nuclear Nonproliferation Treaty (NPT) and maintains a policy of 
+“nuclear opacity” or amimut . One report estimates that Israel possesses a nuclear arsenal of 
+around 90 warheads.50 The United States has countenanced Israel’s nuclear ambiguity since 1969, 
+when Israeli Prime Minister Golda Meir and U.S. President Richard Nixon reportedly reached an 
+accord whereby both sides agreed never to acknowledge Israel’s nuclear arsenal in public.51 Israel 
+might have nuclear weapons deployable via aircraft, submarine, and ground-based missiles.52 No 
+other Middle Eastern country is generally thought to possess nuclear weapons. 
+
+ U.S.-Israel Security Cooperation 
+ U.S.-Israel security cooperation—a critical part of the bilateral relationship—is multifaceted. U.S. 
+law requires the executive branch to take certain actions to preserve Israel’s “qualitative military 
+edge,” or QME over neighboring militaries, and expedites aid and arms sales to Israel in various 
+
+ 
+50 Hans M. Kristensen and Matt Korda, “Israel nuclear weapons, 2021,” Bulletin of the Atomic Scientists , Vol. 78, No. 
+1, 2022, pp. 38-50. 
+
+51 Eli Lake, “Secret U.S.-Israel Nuclear Accord in Jeopardy,” Washington Times , May 6, 2009. 
+52 Kristensen and Korda; “Strategic Weapon Systems,” Janes Sentinel Security Assessment – Eastern Mediterranean , 
+November 16, 2021; “Operation Samson: Israel’s Deployment of Nuclear Missiles on Subs from Germany,” Der 
+Spiegel , June 4, 2012. 
+
+Congressional Research Service 
+
+ 
+
+11 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ways. Israel relies on advantages in equipment and training to compensate for neighboring 
+countries’ advantages in population and territorial size. 
+
+U.S. military aid has helped transform Israel’s armed forces into one of the most technologically 
+sophisticated militaries in the world. Congress’s authorization for Israel to use a portion of this 
+aid for off shore procurement (OSP) from Israeli defense companies (OSP is currently being 
+phased out and is scheduled to end in FY2028) has helped Israel build a domestic defense 
+industry, and Israel in turn is one of the top exporters of arms worldwide.53 The United States and 
+Israel also regularly conduct joint exercises and consultations, and often cooperate in developing 
+military technology, with the U.S. military using or adapting a number of Israel-origin items.54 
+
+ Sensitive Technology and Intelligence Issues 
+
+Arms sales, information sharing, and technical col aboration between the United States and Israel raise questions 
+about what Israel might do with capabilities or information it acquires. The United States and Israel have regularly 
+discussed Israel’s dealings on sensitive security equipment and technology with various countries, such as in the 
+past with China. Sources have reported that the United States has established de facto veto power over Israeli 
+third-party arms sales.55 In at least three cases since the 1980s, U.S. courts have convicted U.S. government 
+employees of disclosing classified information to Israel or of conspiracy to act as an Israeli agent.56 
+The possible use of spyware from the Israel-based company NSO Group by numerous countries throughout the 
+world became a major controversy in 2021 and is an ongoing subject of international concern.57 The U.S. 
+Commerce Department’s Bureau of Industry and Security added NSO to its “Entity List” for engaging in activities 
+that are contrary to the national security or foreign policy interests of the United States.58 In December 2021, 
+Israel altered its export licensing policy for cybersecurity software, requiring purchasers to pledge they wil not 
+use Israeli equipment to commit “terrorist acts” or “serious crime,” as defined by Israel’s Defense Exports 
+Control Agency.59 
+
+U.S. officials routinely express their commitment to Israel’s security. The United States and Israel 
+do not have a mutual defense treaty or agreement that provides formal U.S. security guarantees. 
+They do, however, have a Mutual Defense Assistance Agreement in effect (TIAS 2675, dated July 
+23, 1952) regarding the provision of U.S. military equipment to Israel, and have entered into a 
+range of stand-alone agreements, memoranda of understanding, and other arrangements varying 
+in their formality. The U.S.-Israel Enhanced Security Cooperation Act (P.L. 112-150) of 2012 and 
+U.S.-Israel Strategic Partnership Act (P.L. 113-296) of 2014 encouraged continued and expanded 
+U.S.-Israel cooperation in a number of areas, including defense, homeland security, cyber issues, 
+energy, and trade. The latter act designated Israel as a “major strategic partner” of the United 
+ 
+53 According to a March 2022 report, Israel was the 10th-largest arms exporter in the world between 2017 and 2021, 
+with 37% of Israeli weapons exported during that period reportedly going to India, 13% to Azerbaijan, and 11% to 
+Vietnam. Stockholm International Peace Research Institute, Trends in International Arms Transfers, 2021 , March 
+2022. 
+
+54 See https://www.jewishvirtuallibrary.org/israeli-military-equipment-used-by-the-u-s. 
+55 Barbara Opall-Rome, “U.S. OKs Israel-China Spy Sat Deal,” Defense News , October 12, 2007. 
+56 The most prominent espionage case is that of Jonathan Pollard, who pled guilty in 1986 with his then wife Anne to 
+selling classified documents to Israel. Israel later acknowledged that Pollard had been its agent, granted him 
+citizenship, and began petitioning the United States for his release. Pollard was released on parole in November 2015 
+and permitted to move to Israel in 2020. The other two cases are of Department of Defense analyst Lawrence Franklin 
+(pled guilty to disclosing classified information in 2006) and Ben-Ami Kadish (pled guilty in 2009 to conspiracy to act 
+as an unregistered agent of Israel). 
+
+57 For more information, see CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. See also Ronen 
+Bergman and Mark Mazzetti, “The Battle for the World’s Most Powerful Cyberweapon,” New York Times Magazine , 
+January 28, 2022. 
+
+58 Available online at https://www.commerce.gov/news/press-releases/2021/11/commerce-adds-nso-group-and-other-
+foreign-companies-entity-list. 
+
+59 “Israel Issues Stricter Guidelines for Use of Its Cyber Tech Exports,” Reuters , December 6, 2021. 
+
+Congressional Research Service 
+
+ 
+
+12 
+
+ 
+ link to page 21 Israel: Background and U.S. Relations 
+
+ 
+
+States—a designation whose meaning has not been further defined in U.S. law or by the 
+executive branch. 
+
+A 10-year bilateral military aid memorandum of understanding (MOU)—signed in 2016—
+commits the United States to annually provide Israel $3.3 billion in Foreign Military Financing 
+(FMF) and $500 million on joint missile defense programs from FY2019 to FY2028, subject to 
+congressional appropriations. The MOU anticipates possible supplemental aid in emergency 
+situations such as conflict. In March 2022, Congress appropriated $1 billion in supplemental 
+funding through FY2024 for the Iron Dome anti-rocket system as a response to the system’s 
+heavy use during a May 2021 conflict between Israel and Gaza Strip-based groups such as Hamas 
+and Palestine Islamic Jihad (PIJ) (both of which are Sunni Islamist groups allied with Iran and 
+U.S.-designated terrorist organizations). 
+
+Specific figures and comprehensive detail regarding various aspects of U.S. aid and arms sales to 
+Israel are discussed in CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. 
+That report includes information on conditions that generally allow Israel to use its military aid 
+earlier and more flexibly than other countries in each fiscal year. 
+
+ Israeli-Palestinian Issues and U.S. Policy 
+
+ Overview of Disputes and Diplomatic Efforts 
+ The Biden Administration and the 117th Congress have continued longstanding U.S. engagement 
+on the Israeli-Palestinian conflict, which has been a persistent subject of international concern for 
+decades since the first Arab-Israeli war in 1948. Israel gained control of the West Bank (including 
+East Jerusalem) and the Gaza Strip during the June 1967 Arab-Israeli war (also known as the Six-
+Day War). For historical background on the conflict, see CRS Report RL34074, The Palestinians: 
+Background and U.S. Relations , by Jim Zanotti. 
+
+In the 1990s, after the end of the Cold War and first Gulf War, Israel and the Palestine Liberation 
+Organization (PLO) agreed to work toward a diplomatic resolution of key issues of Israeli-
+Palestinian dispute, including security parameters, borders, Jewish settlements, Palestinian 
+refugees, and the status of Jerusalem. Per the Oslo agreements, the PLO came out of exile and 
+accepted limited self-rule in parts of the West Bank and in the Gaza Strip in the form of a new 
+Palestinian National Authority, or Palestinian Authority (PA), that formally adopted democratic 
+means of governance. In the almost 30 years since, the two sides have engaged in a mix of 
+interactions that include occasional U.S.-brokered negotiations, a combination of practical 
+coordination and political contention, and competing efforts to enlist international support. To 
+date, the key issues of dispute remain unresolved. 
+
+Within a context of overarching Israeli control, multiple outbreaks of violence have occurred 
+between Israelis and Palestinians in the West Bank and Jerusalem. After some PA authorities 
+became directly involved in violence against Israel during the 2000-2005 second Palestinian 
+ intifada (“uprising”) under the rule of iconic Palestinian leader Yasser Arafat (who died in 2004), 
+Israel heightened security measures in and around the West Bank and sensitive parts of Jerusalem. 
+These measures have included the controversial construction of a partial West Bank barrier (see 
+ “Settlements”) . 
+
+With U.S. help, Israel cultivated closer security cooperation with the PA after the second intifada 
+under Arafat’s successor as president, Mahmoud Abbas. However, Abbas’s public stance against 
+using PA security forces against Israel may have increased his domestic political vulnerability, 
+alongside widespread allegations that the PA has been corrupt and repressive under his leadership. 
+
+Congressional Research Service 
+
+ 
+
+13 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+Groups willing to use violence, including Hamas and PIJ and some from Abbas’s own Fatah 
+movement, have sought to portray themselves as more authentic reflections of Palestinian 
+nationalism.60 When Israeli-Palestinian tensions spike, these groups often publicly encourage the 
+use of violence as a means of reinforcing their popularity. 
+
+In 2007, two years after Israel’s military withdrew from Gaza, Hamas forcibly displaced the PA 
+as the de facto authority there. Hamas has controlled the territory since then, subject to Israeli and 
+Egyptian access restrictions and occasional conflicts in which Hamas and other militants have 
+fired rockets from Gaza while Israel has carried out airstrikes and other military operations in and 
+around Gaza (see text box below). 
+
+ Gaza and Its Challenges 
+
+The Gaza Strip—control ed by Hamas, but significantly affected by general Israeli and Egyptian access and 
+import/export restrictions—faces difficult and complicated political, economic, and humanitarian conditions.61 
+Palestinian militants in Gaza clash at times with Israel’s military as it patrols Gaza’s frontiers with Israel, with 
+militant actions and Israeli responses sometimes endangering civilians in both places. These incidents occasionally 
+escalate toward larger conflict, as in May 2021. Hamas and Israel reportedly work through Egypt and Qatar to 
+help manage the flow of necessary resources into Gaza and prevent or manage conflict escalation. Since 2018, 
+Egypt and Hamas (perhaps with implied Israeli approval) have permitted some commercial trade via the informal 
+Salah al Din crossing that bypasses the formal PA controls and taxes at other Gaza crossings.62 
+With Gaza under Hamas control, the obstacles to internationally supported recovery from the May 2021 conflict 
+remain largely the same as after previous Israel-Gaza conflicts in 2008-2009, 2012, and 2014.63 Because of the PA’s 
+inability to control security in Gaza, it has been unwil ing to manage donor pledges toward reconstruction, leading 
+to concerns about Hamas diverting international assistance for its own purposes.64 Before the 2021 conflict, Qatar 
+had provided cash assistance for Gaza, but due to Israeli concerns about the potential for its diversion, Qatar 
+began an arrangement in September 2021 to provide money transfers to needy families through the United 
+Nations.65 In November 2021, Qatar and Egypt agreed on a new mechanism—with Israel’s tacit approval—to 
+restart assistance toward Gaza civil servants’ salaries that had been on hold since the May 2021 outbreak of 
+conflict.66 
+
+Traditionally, the PLO/PA has relied on political and financial support from Arab countries and 
+other international actors while seeking Palestinian statehood via a peace agreement with Israel. 
+In the 2002 Arab Peace Initiative, the League of Arab States (Arab League) agreed to certain 
+reference points on issues of Israeli-Palestinian dispute in an effort to elicit Israeli diplomatic 
+compromise.67 Over the past decade, however, many Arab governments have become 
+
+ 
+60 For additional information on Palestinian groups, see CRS Report RL34074, The Palestinians: Background and U.S. 
+Relations , by Jim Zanotti. 
+
+61 CRS Report RL34074, The Palestinians: Background and U.S. Relations , by Jim Zanotti. 
+62 Ahmad Abu Amer, “Egypt, Qatar agreement with Israel, Hamas provides boost for Gaza economy,” Al-Monitor , 
+November 23, 2021; Neri Zilber, “New Gaza Crossing Raises Questions About Blockade Policies,” Washington 
+Institute for Near East Policy, October 23, 2019. 
+
+63 David Makovsky, “Why Blinken Will Have a Tough Sell,” Washington Institute for Near East Policy, May 25, 2021. 
+64 Ibid. 
+65 Aaron Boxerman, “UN to begin dispensing Qatari cash to needy Gazan families Monday under new deal,” Times of 
+Israel , September 12, 2021. 
+
+66 Yaniv Kubovich, “Egypt, Qatar Reach Breakthrough on Hamas Civil Servants Salaries,” haaretz.com, November 29, 
+2021; Abu Amer, “Egypt, Qatar agreement with Israel, Hamas.” 
+67 The Arab Peace Initiative offers a comprehensive Arab peace with Israel if Israel were to withdraw fully from the 
+territories it occupied in 1967, agree to the establishment of a Palestinian state with a capital in East Jerusalem, and 
+provide for the “[a]chievement of a just solution to the Palestinian Refugee problem in accordance with UN General 
+Assembly Resolution 194.” The initiative was proposed by Saudi Arabia, adopted by the 22-member Arab League 
+(which includes the PLO), and later accepted by the 56-member Organization of the Islamic Conference (now the 
+
+Congressional Research Service 
+
+ 
+
+14 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+preoccupied with domestic survival and regional threats from Iran and non-state actors, and also 
+have begun adjusting to a changing global order with a less dominant U.S. role in the Middle 
+East. Thus, through the Abraham Accords and other developments, some Arab leaders have 
+sought closer relations with Israel—due to its strong and technologically advanced military and 
+economy—despite Palestinians’ unresolved national demands. Some Arab states also have 
+significantly reduced financial support for the PA.68 
+
+Israel has taken some steps to improve Palestinians’ economic and living circumstances, 
+including through loans and work permits.69 However, some critics charge that the measures 
+mirror past Israeli efforts to manage the conflict’s effects unilaterally rather than address its 
+causes through negotiation with Palestinians.70 
+
+In this context, PLO/PA leaders have supported diplomatic efforts and actions within international 
+organizations aimed at applying pressure on Israel to return to negotiations or end controversial 
+practices associated with its control over Palestinians. PA President Abbas (who also chairs the 
+PLO) and other leading Palestinian figures have warned that time may run out for Israeli-
+Palestinian negotiations, threatening to pursue more robust international political, economic, and 
+legal means to advance Palestinian human rights and self-determination claims.71 Egypt and 
+Jordan, which made peace with Israel in previous decades and are direct neighbors of Israel and 
+the Palestinians, continue to express interest in facilitating Israeli-Palestinian peace. 
+
+ The Biden Administration: Diplomacy and Human Rights 
+Considerations 
+ Biden Administration officials have said that they seek to preserve the viability of a negotiated 
+two-state solution to the Israeli-Palestinian conflict, while playing down near-term prospects for 
+direct Israeli-Palestinian negotiations.72 In doing so, they seek to help manage tensions, bolster 
+Israel’s defensive capabilities, and strengthen U.S.-Palestinian ties that frayed during the Trump 
+Administration. As mentioned above, these officials regularly speak out against steps taken by 
+Israelis or Palestinians that could risk sparking violence and undermining the vision of two 
+states—including settlement expansion and settler violence, demolitions, evictions, incitement to 
+violence, and payments for individuals imprisoned for acts of terrorism.73 
+
+Some international bodies have subjected alleged Israeli human rights violations against 
+Palestinians to further legal and political scrutiny. In March 2021, the International Criminal 
+Court (ICC) prosecutor began an investigation into possible crimes in the West Bank and Gaza.74 
+ 
+Organization of Islamic Cooperation) at its 2005 Mecca summit. The text of the initiative is available at 
+http://www.bitterlemons.org/docs/summit.html. 
+
+68 Adnan Abu Amer, “Why has Gulf aid to PA declined in recent years?” Al-Monitor , March 11, 2021. 
+69 Thomas Grove and Fatima AbdulKarim, “Israel Offers Economic Help to Palestinians in Bid to Stem Influence of 
+Hamas,” Wall Street Journal , February 8, 2022; Aaron Boxerman, “Israel set to raise work permit quotas for Gazans to 
+20,000,” Times of Israel , March 26, 2022. 
+
+70 Neri Zilber, “Israel’s new plan is to ‘shrink,’ not solve, the Palestinian conflict,” CNN , September 16, 2021. 
+71 Transcript of Abbas’s September 24, 2021, speech before the U.N. General Assembly available at 
+https://estatements.unmeetings.org/estatements/10.0010/20210924/7gIp44D6mxWV/8xz66G7sjKRg_en.pdf. 
+
+72 White House, “Remarks by President Biden Before the 76th Session of the United Nations General Assembly,” 
+September 21, 2021. 
+
+73 State Department, “Secretary Antony J. Blinken and Israeli Prime Minister Naftali Bennett After Their Meeting,” 
+Jerusalem, March 27, 2022. 
+
+74 CRS Report RL34074, The Palestinians: Background and U.S. Relations , by Jim Zanotti. 
+
+Congressional Research Service 
+
+ 
+
+15 
+
+ 
+ link to page 34 link to page 6 Israel: Background and U.S. Relations 
+
+ 
+
+The investigation might draw from the findings of an ongoing commission of inquiry established 
+by the U.N. Human Rights Council in May 2021 after a major Israel-Gaza conflict.75 The Biden 
+Administration responded skeptically to the creation of the “open-ended” commission of 
+inquiry.76 Like its predecessors, the Administration has criticized the Human Rights Council for 
+what it characterizes as a disproportionate focus on Israel.77 In March 2022, 68 Senators signed a 
+letter urging Secretary of State Antony Blinken to lead a multinational effort to end the 
+commission.78 That same month, the U.N. Special Rapporteur for the “situation of human rights 
+in the Palestinian territory occupied since 1967” reported to the Council that Israel is practicing 
+“apartheid” in that territory.79 
+
+Members of Congress have taken varying positions on human rights-related concerns. Some 
+Members have increased their scrutiny over Israel’s use of U.S. security assistance, contributing 
+to debate on the subject.80 Some other Members have stated their opposition81 to a State 
+Department proposal to fund one or two organizations to “strengthen accountability and human 
+rights in Israel and the West Bank and Gaza.”82 
+
+ Violence and Controversy in 2022 
+
+Since March 2022, a wave of Israeli-Palestinian violence has resulted to date in the deaths of 19 Israelis or 
+foreigners in Israel and more than 40 Palestinians,83 amid the fol owing: 
+ 
+
+Protests and violent altercations around Jerusalem holy sites, including during religious holidays and other 
+sensitive times commemorating historical events (see “Tensions” ). 
+
+ 
+
+Heightened Israeli and PA security measures to counter alleged Palestinian lawlessness and militancy in West 
+Bank cities such as Jenin.84 
+
+In May 2022, prominent Al Jazeera journalist Shireen Abu Akleh (a Palestinian Christian from East Jerusalem who 
+was a U.S. citizen) was kil ed by a gunshot in an area of Jenin where Israeli security forces were trading fire with 
+Palestinians. Her death triggered a major international outcry, as did images of Israeli police disrupting her funeral 
+in East Jerusalem. In condemning Abu Akleh’s kil ing and an injury suffered by one of her col eagues, the State 
+
+ 
+75 U.N. document, A/HRC/RES/S-30/1, May 27, 2021. The Council mandated the commission “to investigate in the 
+Occupied Palestinian Territory, including East Jerusalem, and in Israel all alleged violations of international 
+humanitarian law and all alleged violations and abuses of international human rights law leading up to and since 13 
+April 2021, and all underlying root causes of recurrent tensions, instability and protraction of conflict, including 
+systematic discrimination and repression based on national, ethnic, racial or religious identity.” 
+
+76 U.S. Mission to International Organizations in Geneva, “Press Statement: UN Human Rights Council Session on the 
+Israeli-Palestinian Situation,” May 27, 2021. 
+
+77 U.S. Mission to International Organizations in Geneva, “Secretary Blinken: Remarks to the 46th Session of the 
+Human Rights Council,” February 24, 2021. For more on Israel and the U.N. Human Rights Council, see CRS Report 
+RL33608, The United Nations Human Rights Council: Background and Policy Issues , by Luisa Blanchfield and 
+Michael A. Weber. 
+
+78 The text of the letter is available at https://www.portman.senate.gov/sites/default/files/2022-03/2022-03-
+28%20Letter%20to%20Sec%20Blinken%20on%20UNHRC%20Commission%20of%20Inquiry%20on%20Israel.pdf. 
+
+79 U.N. document A/HRC/49/87 (Advance Unedited Version), March 21, 2022. The international advocacy groups 
+Amnesty International and Human Rights Watch also have labeled Israeli practices as “apartheid.” For general 
+information on Israeli human rights practices regarding Palestinians, see State Department, 2021 Country Report on 
+Human Rights Practices: Israel, West Bank and Gaza. 
+
+80 See footno te 1. 
+ 81 Omri Nahmias, “‘Rescind $1-million grants to anti-Israel NGOs,’ Republican senators tell Blinken,” jpost.com, May 
+24, 2022. 
+
+82 State Department Funding Opportunity Announcement, Bureau of Democracy, Human Rights, and Labor, “DRL 
+Strengthening Human Rights and Accountability in Israel and the West Bank and Gaza,” February 11, 2022. 
+
+83 David S. Cloud and Anas Baba, “Israeli Work Permits Ease Gaza Tensions,” Wall Street Journal , May 28, 2022. 
+84 Ahmad Melhem, “Israeli forces find tough resistance in Jenin camp,” Al-Monitor , May 25, 2022. 
+
+Congressional Research Service 
+
+ 
+
+16 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+Department spokesperson called for an immediate and thorough investigation and ful accountability, and said that 
+Israel has “the wherewithal and the capabilities to conduct a thorough, comprehensive investigation.”85 Some 
+evidence suggests that the shot may have come from Israeli forces,86 with the PA claiming that its investigation 
+proves Israeli forces deliberately targeted Abu Akleh, but Israel denying any such intent.87 It is unclear whether 
+and how Israel, the PA, or other parties might further investigate the matter, and whether U.S. authorities could 
+be involved.88 Fifty-seven Members of Congress sent a letter to the State Department and FBI requesting that they 
+investigate.89 In April 2022, some advocacy groups and lawyers had filed a complaint with the ICC alleging that 
+Israel has systematically targeted Palestinian journalists for years.90 
+
+ Settlements 
+
+ Overview 
+
+Israel has approximately 132 official residential communities in the West Bank (known 
+internationally and by significant segments of Israeli society as “settlements”), and approximately 
+141 additional settlement outposts unauthorized under Israeli law.91 It also maintains other 
+military and civilian land-use sites in the West Bank. Taken together, Israel’s footprint in these 
+areas significantly constrains Palestinian claims, movement, and access in the West Bank. In 
+addition, Israeli authorities and Jewish Israeli citizens have established roughly 14 main 
+residential areas (referred to variously as “settlements” or “neighborhoods”) in East Jerusalem.92 
+All of these residential communities are located beyond the 1949-1967 Israel-Jordan armistice 
+line (the “Green Line”) in areas that Palestinians assert are rightfully part of their envisioned 
+future state. 
+
+ Table 3. Jewish Population in Specific Areas 
+
+(all amounts approximate) 
+
+ % of Total Population 
+
+ % of Population of 
+
+ Area 
+
+ Jewish Population 
+
+ of Israel 
+
+ That Area 
+
+West Bank 
+
+432,000 
+
+4.8% 
+
+12.6% 
+
+(not counting East Jerusalem) 
+
+East Jerusalem 
+
+227,100 
+
+2.5% 
+
+38.2% 
+
+ Sources: Based on figures from the CIA World Factbook and Israel Central Bureau of Statistics (ICBS). 
+
+The first West Bank settlements were constructed following the 1967 war, and Israel initially 
+justified them as residential areas connected to personnel involved with the military occupation. 
+
+ 
+85 State Department Press Briefing, May 11, 2022. 
+86 Josef Federman, “Bellingcat probe suggests Israeli fire most likely killed journalist; but not 100%,” May 16, 2022. 
+87 “Palestinian officials: Israel killed Al Jazeera reporter,” Associated Press , May 26, 2022. 
+88 Joseph Krauss, “US has not been asked to help in probe of reporter’s killing,” Associated Press , May 25, 2022; Lazar 
+Berman, “PA refers Abu Akleh death to International Criminal Court prosecutors” Times of Israel , May 23, 2022. 
+89 Text of letter available at 
+https://carson.house.gov/sites/carson.house.gov/files/Carson%20Shireen%20Abu%20Abkleh%20signed.pdf. 
+
+90 International Federation of Journalists, “Palestine: ICC case filed over systematic targeting of Palestinian 
+journalists,” April 26, 2022. 
+
+91 Data available at https://peacenow.org.il/en/settlements-watch/settlements-data/population. 
+92 For information on the planning and permitting process for settlement construction, see http://peacenow.org.il/wp-
+content/uploads/2017/10/Planning-Process-Chart.pdf. 
+
+Congressional Research Service 
+
+ 
+
+17 
+
+ 
+ link to page 25 Israel: Background and U.S. Relations 
+
+ 
+
+Major West Bank residential settlement building began in the late 1970s with the advent of the 
+pro-settler Gush Emunim (“Bloc of the Faithful”) movement and the 1977 electoral victory of 
+Menachem Begin and the Likud party. Subsequently, Israelis have expanded existing settlements 
+and established new ones. Israelis who defend the settlements’ legitimacy generally use some 
+combination of legal, historical, strategic, nationalistic, or religious justifications.93 
+
+ Figure 2. Population of Israeli West Bank Settlements 
+
+(not including Jewish Israeli East Jerusalem residential communities) 
+
+Population
+
+500k
+
+400k
+
+300k
+
+200k
+
+100k
+
+0k
+
+ 
+
+ Source: ICBS. 
+
+Most countries consider these settlements to be illegal transfers of civilian populations to 
+occupied territory, though U.S. stances on this issue since 1967 have varied (see “U.S. Policy”) .94 
+U.N. Security Council Resolution 2334, adopted in December 2016 with the United States as the 
+lone abstention, stated that settlements established by Israel in “Palestinian territory occupied 
+since 1967, including East Jerusalem,” constitute “a flagrant violation under international law” 
+and a “major obstacle” to a two-state solution and a “just, lasting and comprehensive peace.” 
+Israel, in contrast, asserts that the West Bank is “disputed territory” rather than “occupied 
+territory,” and that building civilian settlements or applying Israeli law in the territory does not 
+violate international law.95 
+
+ 
+93 For more information on the history of the settlements and their impact on Israeli society, see Idith Zertal and Akiva 
+Eldar, Lords of the Land: The War for Israel’s Settlements in the Occupied Territories, 1967-2007 , New York: Nation 
+Books, 2007; Gershom Gorenberg, The Accidental Empire: Israel and the Birth of the Settlements, 1967-1977 , New 
+York: Times Books, 2006. Some Israelis refer to the West Bank as “Judea and Samaria” based on their identification of 
+the land with Jewish historical and religious narratives. 
+
+94 The most-cited international law pertaining to Israeli settlements is the Fourth Geneva Convention, Part III, Section 
+III, Article 49 Relative to the Protection of Civilian Persons in Time of War , August 12, 1949, which states in its last 
+sentence, “The Occupying Power shall not deport or transfer parts of its own civilian population into the territory it 
+occupies.” 
+95 See, e.g., Dore Gold, “The debate over the future of the territories,” israelhayom.com, June 17, 2020; Israel Ministry 
+of Foreign Affairs, Israeli Settlements and International Law, November 30, 2015; Britain Israel Communications and 
+Research Centre, “Extending Israeli sovereignty in the West Bank,” June 2020. Israel argues that the previous 
+occupying power (Jordan) did not have an internationally recognized claim to the West Bank (only a few countries 
+
+Congressional Research Service 
+
+ 
+
+18 
+
+ 
+ link to page 23 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+Israel has largely completed a separation barrier that roughly tracks the Green Line, but departs 
+from it in a number of areas that include significant settlement populations (se e Figure 3 ) .96 Not 
+counting East Jerusalem, one source states that 77% of Israeli settlers live within the barrier’s 
+perimeter.97 Counting East Jerusalem, the figure grows to 84%.98 
+
+Israeli officials state that the barrier’s purpose is to separate Israelis and Palestinians and prevent 
+terrorists from entering Israel. Palestinians object to places where the barrier runs beyond the 
+Green Line because it cuts Palestinians off from East Jerusalem and, in some places, bisects their 
+landholdings and communities. Many Palestinians decry it as an Israeli device to integrate 
+occupied territory into Israel proper.99 
+
+ Figure 3. Map of West Bank 
+
+ 
+
+ Source: U.N. Office for the Coordination of Humanitarian Affairs occupied Palestinian territory, 2018. 
+
+ 
+recognized Jordan’s 1950 annexation of the territory), and that in view of the demise of the Ottoman Empire at the end 
+of World War I and the end of the British Mandate in 1948, no international actor has superior legal claim to Israel’s. 
+After Israel’s 1967 capture of the West Bank, its government has accepted some responsibilities for the territory and its 
+inhabitants in line with the Geneva Conventions. 
+
+96 In a July 2004 International Court of Justice advisory opinion, the barrier’s construction was deemed illegal. The text 
+of the opinion is available at http://www.icj-cij.org/docket/index.php?pr=71&code=mwp&p1=3&p2=4&p3=6. 
+
+97 Information as of 2022 accessed from Washington Institute of Near East Policy’s “Settlements and Solutions” 
+interactive map at https://www.washingtoninstitute.org/westbankinteractivemap/?widget=Information. 
+
+98 Ibid. 
+99 “Israeli barrier: Defensive measure or illegal land grab?” Associated Press , April 26, 2017. 
+
+Congressional Research Service 
+
+ 
+
+19 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Note: Under the Oslo agreements, the West Bank (not including East Jerusalem) is subject to a tiered system of 
+shared control between Israel’s military and the PA in Areas A, B, and C, subject to overarching Israeli security 
+prerogatives. Areas A and B are under PA administration, while Area C is under Israeli administration. 
+
+ Implications 
+
+Settlers affect the political and diplomatic calculus in various ways. They influence key voting 
+blocs in Israel’s coalition-based parliamentary system. Additionally, some initiate public protest 
+and even violent resistance against government efforts to limit or regulate their actions. Also, they 
+claim a significant symbolic role in a country where there is substantial support for historical 
+narratives of national survival based on self-sufficiency and pioneering spirit in the face of 
+adversity. 
+
+As Israel has expanded settlements in the West Bank since 1967, it has integrated many of those 
+settlements and their residents into the political and economic life of Israel proper. As reflected in 
+these settlements’ highly functional infrastructure, local self-governing councils, and 
+transportation and communications links with Israel, there is little to distinguish some of them 
+from towns in Israel proper other than the military’s formal responsibility for their administration. 
+Additionally, some norms of Israeli law already apply to West Bank settlements, “either through 
+application of personal jurisdiction over the settlers, or through military decrees that incorporated 
+Israeli law into the law applicable to all or parts of the West Bank.”100 Since 2016, various 
+Knesset members have reportedly proposed bills that would apply Israeli law, jurisdiction, 
+administration, and formal sovereignty in specified West Bank areas.101 Some observers have 
+characterized the means used or proposed for integrating settlements with Israel proper, along 
+with restrictions on Palestinian building and land use in surrounding areas, as “creeping 
+annexation” or “de facto annexation.”102 
+
+Some Israelis caution that the demand to provide security to settlers, along with other services 
+and transportation links to Israel, could perpetuate Israeli military control in the West Bank even 
+if other rationales for maintaining such control eventually recede. The protection of settlers is 
+complicated by altercations between some settlers and Palestinian West Bank residents, and some 
+settlers’ defiance of Israeli military authorities. An early 2022 report cited increases in West Bank 
+violence between settlers and Palestinians, and settler harassment of Palestinian communities.103 
+
+When ordered by Israel’s court system to dismantle unauthorized outposts, the government has 
+complied. In some cases, the government has placated settlers by relocating displaced outpost 
+residents within the boundaries of settlements permitted under Israeli law.104 In 2020, Israel’s 
+Supreme Court invalidated a 2017 law that had sought to retroactively legalize about 4,000 
+homes built on privately owned Palestinian land.105 
+
+ 
+100 Yuval Shany, “Israel’s New Plan to Annex the West Bank: What Happens Next?” Lawfare Blog, May 6, 2019. See 
+also https://fmep.org/wp/wp-content/uploads/Annexation-Policies.pdf. 
+
+101 Shany, “Israel’s New Plan to Annex the West Bank: What Happens Next?” 
+102 See, e.g., Noa Landau, “Israeli Annexation Explained: What Is Netanyahu Planning for the West Bank and What 
+Does It Mean?” haaretz.com, May 26, 2020. 
+
+103 Patrick Kingsley, “Attacks by Settlers Raise Alarm in a More Violent West Bank,” New York Times , February 13, 
+2022. 
+
+104 See, e.g., Joel Greenberg, “Israeli settlers evacuated from West Bank outpost following court order,” Washington 
+Post , September 2, 2012. 
+
+105 Rami Ayyub, “Israel’s Supreme Court strikes down law legalising settlements on private Palestinian land,” Reuters , 
+June 9, 2020. 
+
+Congressional Research Service 
+
+ 
+
+20 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ U.S. Policy 
+
+U.S. policy on settlements has varied since 1967. Until the 1980s, multiple Administrations either 
+stated or implied that settlements were contrary to international law.106 President Reagan later 
+stated that settlements were “not illegal,” but “ill-advised” and “unnecessarily provocative.”107 
+Since then, a common U.S. stance has been that settlements are an “obstacle to peace.” 
+Additionally, loan guarantees to Israel currently authorized by U.S. law are subject to possible 
+reduction by an amount equal to the amount Israel spends on settlements.108 
+
+A former U.S. official wrote in 2014 that U.S. Administrations are “not entirely sure what to do 
+with the fact that Israeli prime ministers of all political stripes have continued Israeli settlement 
+building on the West Bank and construction in parts of east Jerusalem that we’d like to see 
+become the capital of a Palestinian state.”109 An April 2004 letter from President George W. Bush 
+to then Israeli Prime Minister Ariel Sharon explicitly acknowledged that “in light of new realities 
+on the ground, including already existing major Israeli populations [sic] centers, it is unrealistic to 
+expect that the outcome of final status negotiations will be a full and complete return to the 
+armistice lines of 1949.”110 President Obama signed trade and customs legislation (P.L. 114-26 
+and P.L. 114-125) opposing punitive economic measures against Israel (such as measures 
+advocated by a non-governmental boycott, divestment, and sanctions [BDS] movement). 
+However, he asserted in a presidential signing statement for P.L. 114-125 that certain provisions 
+treating “Israeli-controlled territories” (i.e., West Bank settlements) beyond the Green Line in the 
+same manner as Israel itself were not in line with U.S. policy.111 
+
+The Trump Administration said that the expansion of settlements beyond their current borders 
+may not be helpful to peace,112 but later reversed a 1978 State Department legal advisory letter 
+that had characterized settlements as “inconsistent with international law.”113 The Administration 
+took additional steps in 2020 that could be interpreted as legitimizing Israeli settlements in the 
+West Bank, including changing product labeling guidance to have products from settlement areas 
+labeled “Made in Israel,”114 and removing geographic restrictions that had previously prevented 
+three U.S.-Israel binational research foundations from operating beyond the Green Line.115 The 
+Administration also proposed a peace plan in 2020 that anticipated incorporating settlements into 
+Israel, pending further Israeli-Palestinian negotiation.116 
+
+ 
+106 Daniel Kurtzer, “Do Settlements Matter? An American Perspective,” Middle East Policy , vol. 16, issue 3, fall 2009. 
+107 Nicholas Rostow, “Are the Settlements Illegal?” The American Interest , March/April 2010. 
+108 For more information on this issue, see CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. 
+109 Aaron David Miller, “The Inside Story of U.S. Meddling in Israel’s Elections,” Daily Beast , December 4, 2014. 
+110 Text of letter available at https://georgewbush-whitehouse.archives.gov/news/releases/2004/04/20040414-
+3.html#:~:text=In%20light%20of%20new%20realities,state%20solution%20have%20reached%20the. 
+
+111 See, e.g., a presidential signing statement for P.L. 114-125 (H.R. 644) at https://www.whitehouse.gov/the-press-
+office/2016/02/25/signing-statement-hr-644. For more information, see CRS Report R44281, Israel and the Boycott, 
+Divestment, and Sanctions (BDS) Movement , coordinated by Jim Zanotti. 
+
+112 White House Office of the Press Secretary, Statement by the Press Secretary, February 2, 2017. 
+113 State Department, “Secretary Michael R. Pompeo Remarks to the Press,” November 18, 2019. Text of the 1978 
+letter is available at https://www.justsecurity.org/wp-content/uploads/2016/12/hansellopinion.1978.pdf. 
+
+114 U.S. Customs and Border Protection, “Country of Origin Marking of Products from the West Bank and Gaza,” 85 
+FR 83984, December 23, 2020. 
+
+115 U.S. Embassy in Israel, “BIRD/BARD Speech at Ariel University – As Delivered,” October 29, 2020. 
+116 White House, Peace to Prosperity: A Vision to Improve the Lives of the Palestinian and Israeli People , January 
+2020. 
+
+Congressional Research Service 
+
+ 
+
+21 
+
+ 
+ link to page 29 link to page 29 link to page 22 Israel: Background and U.S. Relations 
+
+ 
+
+The Biden Administration has not taken specific action regarding the Trump Administration 
+policies mentioned above, but has regularly criticized settlement expansion as a unilateral activity 
+that could undermine prospects for a two-state solution.117 Some Israeli settlement construction 
+plans for East Jerusalem and the West Bank have advanced,118 but in 2021 Israel reportedly 
+delayed the process for plans in the controversial “E-1” area (se e Figure 4 ) and another 
+settlement flagged as particularly damaging to the two-state vision by the Biden Administration 
+or some Members of Congress.119 In May 2022, Israel advanced plans for nearly 4,500 additional 
+housing units for West Bank settlements,120 drawing statements of strong opposition from the 
+Administration.121 Israel had reportedly advanced fewer units than originally planned in response 
+to U.S. and domestic political concerns,122 while Foreign Minister Lapid insisted that Israel did 
+not need U.S. permission to build.123 Israel may seek to advance plans for E-1 later in 2022.124 
+
+ Jerusalem 
+ Israel officially considers Jerusalem to be its capital (see Figure 4 below),125 including: 
+
+ The western part of Jerusalem that Israel has controlled since 1948, which has 
+
+served as the official seat of Israel’s government since shortly after its founding 
+as a state. 
+
+ The eastern part that Israel unilaterally incorporated into itself after seizing the 
+
+West Bank in the 1967 Arab-Israeli war. In doing so, Israel, expanded the city’s 
+municipal boundaries to encompass some neighborhoods and villages not part of 
+the city during Jordan’s 1948-1967 rule. 
+
+U.N. Security Council Resolution 478 (1980) affirmed that a Knesset law effectively annexing 
+East Jerusalem violated international law.126 Largely because the U.N. General Assembly 
+conferred a special international status on Jerusalem in the partition plan it adopted in 1947 
+(Resolution 181(II)), most countries do not recognize Israeli sovereignty over any part of the city 
+and have their embassies to Israel located elsewhere.127 
+
+ 
+117 State Department, “Secretary Antony J. Blinken and Israeli Prime Minister Naftali Bennett After Their Meeting,” 
+Jerusalem, March 27, 2022. 
+
+118 Hagar Shezaf, “Israel Advances Thousands of Settlement Homes Despite Harsh U.S. Rebuke,” haaretz.com, 
+October 27, 2021. 
+
+119 “Israel stops plan for contentious east Jerusalem settlement,” Associated Press , December 6, 2021; “Plans to move 
+forward with E1 settlement construction reportedly on hold,” Times of Israel , January 6, 2022. 
+
+120 Hagar Shezaf, “Israel Advances over 4,000 West Bank Housing Units for Jews,” haaretz.com, May 12, 2022. 
+121 State Department Press Briefing, May 6, 2022. 
+122 Lahav Harkov and Tovah Lazaroff, “Bennett cut down on settler housing plans to appease US, coalition members,” 
+jpost.com, May 8, 2022. 
+
+123 Lahav Harkov and Tovah Lazaroff, “Lapid: Israel doesn't need permission from the US to build in settlements,” 
+jpost.com, May 10, 2022. 
+
+124 Jacob Magid, “Israel puts E1 settlement project back on agenda, weeks ahead of Biden trip,” Times of Israel , May 
+31, 2022. 
+
+125 In 1980, under the first Likud Party government, the Israeli Knesset passed the Basic Law: Jerusalem—Capital of 
+Israel, which declares “Jerusalem, complete and united, is the capital of Israel.” See http://www.mfa.gov.il for the 
+complete text of the Basic Law. Israel had first declared Jerusalem to be its capital in 1950. 
+
+126 See footno te 94. 
+ 127 See, e.g., Scott R. Anderson and Yishai Schwartz, “How to Move the U.S. Embassy to Jerusalem,” 
+foreignpolicy.com, November 30, 2017. 
+
+Congressional Research Service 
+
+ 
+
+22 
+
+ 
+ link to page 30 link to page 22 link to page 22 Israel: Background and U.S. Relations 
+
+ 
+
+Departing from the decades-long practice of the United States and other countries, the Trump 
+Administration recognized Jerusalem as Israel’s capital in 2017 and moved the location of the 
+U.S. Embassy in Israel from Tel Aviv to Jerusalem in 2018 (se e Figure 5 ) . Palestinian leaders 
+condemned these actions. The President pointed to the Jerusalem Embassy Act of 1995 (P.L. 104-
+45) as a significant factor in the policy change.128 The Palestinians claim East Jerusalem as their 
+future national capital—though the Trump Administration did not take a position on the 
+boundaries of Israeli sovereignty in the city. The Biden Administration has said that the embassy 
+will remain in Jerusalem.129 Following the U.S. embassy move in 2018, a few other countries 
+have opened embassies (Guatemala and Honduras) or embassy branch offices (Hungary and 
+Czech Republic) in Jerusalem. 
+
+ East Jerusalem Controversies 
+
+Various controversies surrounding Israel’s administration of Jerusalem stem from its being under 
+Israeli domestic jurisdiction, while (as mentioned above) most countries view the entire city’s 
+status as still subject to negotiation and consider East Jerusalem to be occupied territory (based on 
+its capture from Jordan in the 1967 war).130 Israel’s national government and the municipal 
+government for Jerusalem apply Israeli law in the city. Most Arabs in East Jerusalem have 
+permanent resident status in Israel, but identify as Palestinians and are not Israeli citizens,131 and 
+do not participate in Jerusalem municipality elections.132 They can lose their residency status if 
+Israeli authorities determine that East Jerusalem is no longer their primary residence.133 
+ Within the context of competing national and religious narratives regarding Jerusalem. Israelis 
+have routinely used their influence with municipal and national authorities to advance Jewish 
+objectives in the city, while Palestinians with marginal direct influence over Jerusalem’s formal 
+administration have engaged in protests and occasionally violence, attracting international 
+attention.134 For 2021, the State Department reported that “the Jerusalem municipality and other 
+authorities failed to provide sufficient social services, education, infrastructure, and emergency 
+planning for Palestinian neighborhoods, especially in the areas between the [separation] barrier 
+and the municipal boundary. Approximately 117,000 Palestinians lived in that area, of whom 
+approximately 61,000 were registered as Jerusalem residents, according to government data.”135 
+ Ongoing East Jerusalem controversies that have attracted U.S. and international attention include: 
+
+ 
+128 The Act called for the establishment of the U.S. embassy in Israel in Jerusalem by May 31, 1999, and provided for 
+the holding back of 50% of the applicable fiscal year’s “Acquisition and Maintenance of Buildings Abroad” budget for 
+the State Department until the embassy’s relocation. Before the relocation in 2018, Administrations from Clinton to 
+Trump had exercised the Act’s presidential waiver every six months (beginning in 1999) to suspend the budgetary 
+limitation after determining that doing so was necessary to protect U.S. national security interests. 
+
+129 Niels Lesniewski, “White House confirms Biden will keep embassy in Jerusalem,” Roll Call , February 9, 2021. 
+130 The international law debate on East Jerusalem essentially mirrors the debate on the West Bank (see footno te 94 and 
+footno te 95). 
+
+131 Nir Hasson, “Israel Eases Path to Citizenship for 20,000 East Jerusalem Palestinians,” haaretz.com, November 25, 
+2020. A naturalization process does permit some non-Jewish residents of East Jerusalem to obtain Israeli citizenship. 
+
+132 Eetta Prince-Gibson, “Why There’s No Palestinian Protest Vote in Jerusalem,” foreignpolicy.com, November 19, 
+2018. 
+
+133 Robinson, “What to Know About the Arab Citizens of Israel.” 
+134 See, e.g., Patrick Kingsley, “Evictions in Jerusalem Become Focus of Israeli-Palestinian Conflict,” New York Times , 
+May 7, 2021. 
+
+135 State Department, 2021 Country Report on Human Rights Practices: Israel, West Bank and Gaza. 
+
+Congressional Research Service 
+
+ 
+
+23 
+
+ 
+ link to page 19 Israel: Background and U.S. Relations 
+
+ 
+
+ Threats to Palestinian contiguity. Israeli plans to build or expand Jewish neighborhoods 
+
+could significantly affect geographical contiguity between Palestinian neighborhoods in 
+East Jerusalem and the West Bank.136 
+
+ Evictions and demolitions. The status of some Palestinian residents in the Old City and 
+
+other neighborhoods (such as Sheikh Jarrah, Silwan, and Walaja) is precarious. Israeli 
+evictions and demolitions (or ongoing threats of such action) affecting these people fuel 
+protests and legal action,137 and the Biden Administration has criticized these actions—
+sometimes with regard to specific cases.138 The State Department has highlighted the 
+non-reciprocal nature of Israeli law as applied to East Jerusalem property disputes. The 
+law authorizes Israeli suits to reacquire East Jerusalem land based on pre-1948 ownership 
+claims, and generally prohibits Palestinian suits to reacquire land on the other side of the 
+Green Line based on similar pre-1948 ownership claims.139 
+
+ Treatment of non-Jewish communities. According to the State Department, the PA and 
+
+some civil society groups claim that the Israeli government and settler organizations 
+encourage greater Jewish property ownership in East Jerusalem at least partly to 
+emphasize Jewish history in Palestinian neighborhoods.140 Whether the Israel Antiquities 
+Authority gives proper attention to researching non-Jewish periods in the archaeological 
+record has been a subject of debate.141 Two private organizations working toward greater 
+Jewish control and settlement in Jerusalem’s historical basin are Ateret Cohanim 
+(“Crown of the Priests”) and the Ir David (“City of David”) Foundation, also known as 
+Elad.142 In 2020, the leaders of 13 Christian denominations in Jerusalem protested that a 
+controversial legal ruling transferring some Old City property from the Greek Orthodox 
+Patriarchate to Ateret Cohanim represented a systematic attempt “to weaken the Christian 
+presence in Jerusalem.”143 
+
+ 
+
+ 
+136 See, e.g., Aaron Boxerman, “Committee advances plans for new Jerusalem homes beyond Green Line,” Times of 
+Israel , January 17, 2022. 
+
+137 In a March 2022 ruling that narrowly applied to one prominent property case in Sheikh Jarrah, Israel’s Supreme 
+Court halted the eviction of four families pending an examination by the Israeli Ministry of Justice that could take 
+years. Mai Abu Hasaneen, “Israeli court cancels eviction of Palestinian families in Sheikh Jarrah,” Al-Monitor , March 
+10, 2022. 
+
+138 State Department Press Briefing, August 5, 2021; see footno te 73. 
+ 139 State Department, 2021 Country Report on Human Rights Practices: Israel, West Bank and Gaza. 
+140 Ibid. 
+141 State Department, International Religious Freedom Reports for 2020 and 2021, Israel, West Bank, and Gaza. 
+142 “In east Jerusalem, a battle over ‘every inch’ of land,” Agence France Presse , December 20, 2020. 
+143 State Department, International Religious Freedom Report for 2020, Israel, West Bank, and Gaza. 
+
+Congressional Research Service 
+
+ 
+
+24 
+
+ 
+ 
+
+ 
+
+ Figure 4. Greater Jerusalem 
+
+ 
+
+ Note: All locations and lines are approximate. 
+
+CRS-25 
+
+ 
+ 
+
+ 
+
+ Figure 5. Jerusalem: Key Sites in Context 
+
+ 
+
+ Note: All locations and lines are approximate. 
+
+ 
+
+CRS-26 
+
+ 
+ link to page 32 Israel: Background and U.S. Relations 
+
+ 
+
+ The “Status Quo”: Jews and Muslims at the Temple Mount/Haram al Sharif 
+
+ Background 
+ The status of Jerusalem and its holy sites has been a long-standing issue of political and religious 
+contention between Jews and Muslims. A number of violent episodes occurred in Jerusalem 
+during the 1920s and 1930s, and control over the city and key areas in and around it was a major 
+strategic consideration in the Arab-Israeli wars of 1948 and 1967. 
+
+Notwithstanding Israel’s 1967 takeover and subsequent annexation of East Jerusalem, it allowed 
+the Jordanian waqf (or Islamic custodial trust) that had been administering the Temple 
+Mount/Haram al Sharif (the “Mount/Haram”) and its holy sites before the war to continue doing 
+so, and established a “status quo” arrangement that has been Israel’s proclaimed policy since 
+then.144 The Mount/Haram contains some of the most important sites for Abrahamic religions: the 
+foundation of the first and second Jewish temples, the Dome of the Rock, and Al Aqsa Mosque 
+(se e Figure 6 ). 145 
+
+ 
+144 The status of Jordan’s Hashemite king—who traces his descent to the Prophet Muhammad—as custodian of Muslim 
+holy sites in Jerusalem can be traced to (1) a 1924 decision by Arab authorities in Jerusalem during the British Mandate 
+for Palestine (the Grand Mufti and Supreme Muslim Council) to accept the Hashemite dynasty as custodian of the sites 
+after the formal end of the Ottoman sultan’s claim to the Islamic Caliphate, and (2) Jordan’s control over East 
+Jerusalem from 1948 to 1967. It was codified in Jordan’s 1994 peace treaty with Israel, and reinforced in a 2013 
+agreement with the PA. Many Christian leaders in Jerusalem also recognize the king to be custodian over Christian 
+holy sites. 
+
+145 State Department, International Religious Freedom Report for 2020, Israel, West Bank, and Gaza. 
+
+Congressional Research Service 
+
+ 
+
+27 
+
+ 
+ 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Figure 6. Old City of Jerusalem 
+
+ 
+
+Under the Israeli status quo policy, Muslims can access the Mount/Haram and worship there, 
+while Jews and other non-Muslims are permitted access but not allowed to worship. The policy is 
+largely based on past practices dating from the 19th century (while the Ottoman Empire ruled 
+Jerusalem) until the 1948 war.146 Jewish worship is permitted at the Western Wall at the base of 
+the Mount/Haram. The waqf and many other Muslims have a different understanding of the status 
+quo, insisting that only Muslim worshippers should have unrestricted access to the Mount/Haram 
+
+ 
+146 The application of the term “status quo” to Jerusalem’s holy sites dates back to an 1852 Ottoman Empire ruling 
+about the rights of different Christian churches to worship at the Church of the Holy Sepulchre and other Christian 
+sites. The Muslim sites on the Mount/Haram (most notably Al Aqsa Mosque and the Dome of the Rock) were 
+eventually informally incorporated into the status quo arrangement. After the fall of the Ottoman Empire, the League of 
+Nations Palestine Mandate of 1922 gave legal recognition to the status quo. Marlen Eordegian, “British and Israeli 
+Maintenance of the Status Quo in the Holy Places of Christendom,” International Journal of Middle East Studies , Vol. 
+35, No. 2, May 2003. 
+
+Congressional Research Service 
+
+ 
+
+28 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+and rejecting any limits on the waqf’s authority there.147 Israeli police manage entry for non-
+Muslims to the Mount/Haram through one gate, while the waqf manages several other gates 
+permitting entry for Muslims under police supervision. Aside from providing guidance on who 
+can enter and worship at the Mount/Haram and how to conduct security, status quo arrangements 
+also address other matters like construction and archaeological preservation and excavation.148 
+
+In times of tension around the holy sites, U.S. officials routinely call on all parties to maintain the 
+status quo.149 The status quo is criticized and challenged by some rabbis and other individuals or 
+groups who assert that Israel should advance Jewish historical and religious claims to the 
+Mount/Haram, despite rulings from government-appointed rabbis proscribing Jewish visits 
+there.150 Past events fueling concerns among Palestinians about possible Israeli attempts to 
+change the status quo have included: 
+
+ September 1996 clashes leading to the deaths of 54 Palestinians and 14 Israeli 
+
+security personnel after Israel opened a passage leading to/from the Western Wall 
+esplanade through a tunnel (known as the Hasmonean or Kotel Tunnel) that 
+archaeologists had uncovered and restored.151 
+
+ A September 2000 Mount/Haram visit by Likud party leader (and future prime 
+
+minister) Ariel Sharon just prior to the outbreak of the second Palestinian 
+intifada. Shortly after the intifada began, Israel and the Jordanian waqf agreed to 
+close the Mount/Haram completely to non-Muslims.152 
+
+ Israel’s August 2003 reopening of the Mount/Haram to non-Muslims despite the 
+
+waqf’s objections. Since then, the waqf has restricted non-Muslims from entering 
+the Dome of the Rock and Al Aqsa Mosque, marking a change from close daily 
+Israel-waqf coordination regarding the status quo to minimal, irregular 
+coordination.153 
+
+ Various developments from 2014-2017, including temporary Israeli restrictions 
+
+on Mount/Haram access for some Muslims during a wave of Israeli-Palestinian 
+violence, U.S.-brokered Israel-Jordan negotiations about security cameras on the 
+Mount/Haram (which were not ultimately installed), and abortive efforts by Israel 
+to install metal detectors at Muslim access points.154 
+
+Over the past two decades, Jewish Israelis have increasingly sought to visit the Mount/Haram, 
+with over 33,000 visits reported in 2021, triggering debate about the possible erosion of the status 
+quo. Millions of Muslims visit the site annually.155 Because Israeli practices call for police to 
+
+ 
+147 State Department, International Religious Freedom Report for 2020, Israel, West Bank, and Gaza. 
+148 Dov Lieber, “Israeli-Palestinian Clashes Increasing Focus on Holy Site,” Wall Street Journal , April 22, 2022. 
+149 State Department, International Religious Freedom Reports for 2020 and 2021, Israel, West Bank, and Gaza. 
+150 Ibid. 
+151 Wendy Pullan et al., The Struggle for Jerusalem’s Holy Places , Routledge: New York, 2013, p. 37. 
+152 Nir Hasson, “Report: Israel, Jordan in Talks to Readmit Non-Muslim Visitors to Temple Mount Sites,” haaretz.com, 
+June 30, 2015. 
+
+153 “Understanding ‘Status Quo’ on the Temple Mount/Haram al Sharif,” Terrestrial Jerusalem , December 29, 2015; 
+Hasson, “Report: Israel, Jordan in Talks.” 
+154 Luke Baker, “Muslim men over 50 pray at Jerusalem's Aqsa mosque amid tight security,” Reuters , October 31, 
+2014; “Jordan cancels plan for security cameras on Temple Mount,” Times of Israel , April 18, 2016; Jane Onyanga-
+Omara, “Israel removes metal detectors from contested Jerusalem shrine,” USA Today , July 25, 2017. 
+155 Nir Hasson, “Al-Aqsa Won’t Become a Synagogue. There Are Real Reasons to Fight the Occupation,” haaretz.com, 
+April 21, 2022. 
+
+Congressional Research Service 
+
+ 
+
+29 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+escort visiting Jewish groups, the increase in visits has led to more frequent police measures 
+limiting access for some groups of Muslims and Jews during religious holidays and other 
+sensitive times. While Israeli authorities insist that they do not permit Jewish worship, some 
+sources have provided evidence suggesting that at least sometimes the police do not prevent 
+Jewish visitors from praying.156 In April 2022, Israeli Diaspora Affairs Minister Nachman Shai 
+admitted that some Jews’ prayer on the Mount/Haram has led to “a certain deterioration of the 
+status quo.”157 
+
+Some Muslims allege that Israel seeks changes to the Mount/Haram that will eventually displace 
+Muslim worship and access, while Israeli officials generally reject this characterization and say 
+they remain committed to the status quo and countering both Jewish and Muslim extremists.158 
+They criticize Hamas and other Islamist groups for allegedly inciting unrest and efforts to disrupt 
+Jewish visits to the Mount/Haram.159 
+
+ Tensions in 2021 and 2022 
+ Unrest at the Mount/Haram during Ramadan in May 2021, combined with disputes about the 
+possible eviction of several Palestinian families in East Jerusalem, contributed to an environment 
+vulnerable to the broadening of conflict. After Hamas claimed it was defending Jerusalem by 
+firing rockets toward the city from Gaza, its ultimatum for Israeli troops to leave the 
+Mount/Haram factored into the start of a major 11-day Israel-Gaza conflict. 
+
+During an overlap between the Ramadan and Passover holidays in April 2022, Israeli police and 
+Muslims clashed over tensions regarding the status quo—including a few instances in which the 
+police entered Al Aqsa Mosque.160 A committee of Arab foreign ministers meeting in Jordan 
+rejected “all illegal Israeli practices aimed at changing the legal and historical status quo.”161 In 
+calls with Israeli Prime Minister Bennett and Jordanian King Abdullah II, President Biden took 
+note of efforts to reduce tensions.162 The White House reported that during the call with King 
+Abdullah, President Biden “underscored the need to preserve the historic status quo at the Haram 
+al-Sharif/Temple Mount, and recognized the Hashemite Kingdom of Jordan’s role as the 
+custodian of Muslim holy places in Jerusalem.” 
+
+In May 2022, the Jerusalem Magistrate’s Court ruled that Israel did not have a sufficiently 
+compelling reason to prevent three Jewish teenagers from praying at the Mount/Haram, triggering 
+concern about deterioration of the status quo from Jordanian and PA officials.163 The Israeli prime 
+minister’s office released a statement saying it would not change the status quo and that the 
+
+ 
+156 Lieber, “Israeli-Palestinian Clashes Increasing Focus on Holy Site.” 
+157 Jacob Magid, “Status woe: Temple Mount is an enduring thorn in Israel’s ties with Jordan,” Times of Israel , April 
+25, 2022. 
+
+158 Lahav Harkov, “Israel will not change status quo in Jerusalem - Lapid says,” jpost.com, April 20, 2022. 
+159 Jacob Magid, “Arab FMs: End Jewish prayer on Temple Mount; Lapid: Israel committed to status quo,” Times of 
+Israel , April 21, 2022. 
+
+160 “Israeli police, Palestinians clash anew at Jerusalem’s Al-Aqsa mosque compound,” France24 , May 5, 2022. 
+161 “Arab ministerial committee tackles ‘dangerous’ escalation in al-Aqsa,” Jordan News Agency (Petra) , April 21, 
+2022. 
+
+162 White House, “Readout of President Biden’s Call with Prime Minister Naftali Bennett of Israel,” April 24, 2022; 
+and “Readout of President Biden’s Call with His Majesty King Abdullah II of Jordan,” April 25, 2022. 
+163 “Jordan: Court support for Jewish prayer at Temple Mount breaches international law,” Times of Israel , May 23, 
+2022. 
+
+Congressional Research Service 
+
+ 
+
+30 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+court’s ruling only applied to the specifics of the one case.164 Later in May, the Jerusalem District 
+Court overturned the Magistrate’s Court ruling upon the government’s appeal, ruling that 
+freedom of worship on the Temple Mount “is not absolute, and should be superseded by other 
+interests, among them the safeguarding of public order.”165 
+
+ Reopening of U.S. Consulate in Jerusalem? 
+
+Biden Administration officials have said that they plan to reopen the U.S. consulate in Jerusalem 
+that had previously functioned as an independent diplomatic mission in handling relations with 
+the Palestinians, without specifying when the consulate might reopen.166 The Trump 
+Administration merged the consulate into the U.S. Embassy in Israel in March 2019, with the 
+consulate’s functions taken over by a Palestinian Affairs Unit (PAU) within the embassy. 
+Competing Israeli and Palestinian national narratives influence this issue, with both sides 
+appealing to U.S. officials about the importance of Jerusalem and its holy sites to their domestic 
+constituencies.167 
+
+Reestablishing the consulate would require Israeli cooperation, given the need for Israeli 
+authorities to issue visas to and help protect U.S. diplomats.168 In a November 3, 2021, hearing 
+before the House Foreign Affairs Committee, Deputy Secretary of State for Management and 
+Resources Brian McKeon said that “the practical reality is we would need privileges and 
+immunities, which only the state of Israel can provide.”169 Several top Israeli officials, including 
+Prime Minister Bennett and Foreign Minister Lapid, have voiced strong opposition to a proposed 
+reopening in Jerusalem.170 During a visit to the White House in August 2021, Bennett reportedly 
+sought to convince President Biden to open a consulate somewhere in the West Bank near (but 
+not within) Jerusalem, such as Ramallah or the town of Abu Dis.171 In late 2021, Members of 
+Congress introduced bills in both houses (S. 3063 and H.R. 6004) that would oppose reopening a 
+consulate in Jerusalem to handle relations with the Palestinians, and prohibit funding for any 
+diplomatic facility in Jerusalem other than the U.S. Embassy in Israel. 
+
+A December 2021 media report claimed that controversy on the issue led the Biden 
+Administration to effectively shelve plans to reopen the consulate. It also said that the PAU was 
+communicating directly with State Department officials in Washington, rather than working 
+through other embassy channels.172 In June 2022, the PAU was re-branded as the Office of 
+Palestinian Affairs (OPA), with the OPA operating under the auspices of the embassy while 
+reporting directly to Washington.173 This type of direct communication was a core aspect of the 
+ 
+164 Ibid. 
+165 “Israeli Appeal Court Quashes Ruling on Jewish Prayer at Al-Aqsa Compound,” Reuters , May 26, 2022. 
+166 State Department Press Briefing, May 31, 2022. 
+167 Barak Ravid, “U.S. and Israel to form team to solve consulate dispute,” Axios , October 20, 2021; Jack Khoury and 
+Jonathan Lis, “Palestinian Officials Say U.S. Seeks to Reopen Consulate Serving East Jerusalem After Israel Approves 
+Budget,” haaretz.com, October 3, 2021. 
+
+168 Shira Efron and Ibrahim Eid Dalalsha, “Reopening the U.S. Consulate in Jerusalem: Subject to Israeli Discretion?” 
+Israel Policy Forum, January 14, 2021. 
+
+169 Transcript available at http://www.cq.com/doc/congressionaltranscripts-6386943?16. 
+170 “Next test for Israel PM: US plan for Palestinian mission,” Agence France Presse , November 8, 2021. 
+171 Jack Khoury and Jonathan Lis, “Palestinian Officials Say U.S. Seeks to Reopen Consulate Serving East Jerusalem 
+After Israel Approves Budget,” haaretz.com, October 3, 2021. 
+
+172 Jacob Magid, “US holding off on reopening Jerusalem consulate amid strong pushback from Israel,” Times of Israel , 
+December 15, 2021. 
+
+173 Barak Ravid, “State Department separates Palestinian office from U.S. Embassy to Israel,” Axios , June 9, 2022. 
+
+Congressional Research Service 
+
+ 
+
+31 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+previous consulate general’s independent status. Nevertheless, PA President Abbas reportedly 
+continues to press for the reopening of the consulate.174 
+
+ Regional Threats and Relationships 
+
+ Countering Iran 
+ Israeli officials cite Iran as one of their primary concerns, largely because of (1) antipathy toward 
+Israel expressed by Iran’s revolutionary regime, (2) Iran’s broad regional influence (including in 
+Syria, Iraq, Lebanon, and Yemen), and (3) Iran’s nuclear and missile programs and advanced 
+conventional weapons capabilities. Iran-backed groups’ demonstrated abilities since 2019 to 
+penetrate the air defenses of countries like Saudi Arabia and the United Arab Emirates through 
+coordinated drone and missile attacks have implications for Israeli security calculations.175 Israeli 
+observers who anticipate the possibility of a future war similar or greater in magnitude to Israel’s 
+2006 war against Lebanese Hezbollah refer to the small-scale military skirmishes or covert 
+actions since then involving Israel, Iran, or their allies as “the campaign between the wars.”176 
+
+ Iranian Nuclear Issue and Regional Tensions 
+
+Israel has sought to influence U.S. decisions on the international agreement on Iran’s nuclear 
+program (known as the Joint Comprehensive Plan of Action, or JCPOA). Then Prime Minister 
+Netanyahu strenuously opposed the JCPOA in 2015 when it was negotiated by the Obama 
+Administration, and welcomed President Trump’s May 2018 withdrawal of the United States 
+from the JCPOA and accompanying reimposition of U.S. sanctions on Iran’s core economic 
+sectors. Since this time, Iran has increased its enrichment of uranium to levels that could 
+significantly shorten the time it requires to produce fissile material for nuclear weapons.177 
+Reported low-level Israel-Iran conflict has persisted in various settings—including cyberspace, 
+international waters, and the territory of Syria, Lebanon, and Iraq—with implications for regional 
+tensions.178 
+
+As the Biden Administration engages in international diplomacy and considers the possibility of 
+reentering or revising the JCPOA, Israel is reportedly still seeking to influence diplomatic 
+outcomes. Prior to the November 2021 resumption of international negotiations with Iran, Prime 
+Minister Bennett stated that Israel would not be bound by a return to the JCPOA.179 A January 
+2022 report suggested that some leading Israeli security officials might prefer an international 
+deal to no deal because an agreement could provide “increased certainty about the limitations on 
+Iran’s nuclear program, and it would buy more time for Israel to prepare for escalation 
+ 
+174 Barak Ravid, “Scoop: U.S. sending senior diplomat to Ramallah to reassure Palestinians,” Axios , June 8, 2022. 
+175 Farnaz Fassihi and Ronen Bergman, “Drone Strike on Iranian Military Facility Is Deemed an Attack,” New York 
+Times , May 28, 2022; Anna Ahronheim, “How serious is the drone threat against Israel?” jpost.com, March 11, 2022. 
+
+176 See, e.g., Seth J. Frantzman, “Iran and Hezbollah analyze Israel’s ‘war between the wars,’” jpost.com, November 
+14, 2021. 
+
+177 David E. Sanger and William J. Broad, “Iran Nears an Atomic Milestone,” New York Times , September 13, 2021. 
+178 Ben Caspit, “IRGC colonel’s assassination highlights Israel's shift in tactics against Iran,” Al-Monitor , May 24, 
+2022; Dion Nissenbaum, “Israel Steps Up Campaign Against Iran,” Wall Street Journal , April 11, 2022; Arie Egozi, 
+“With missile attack and alleged espionage, Israel-Iran ‘shadow war’ slips into the open,” Breaking Defense , March 16, 
+2022. 
+
+179 Israeli Prime Minister’s Office, “PM Bennett’s Remarks at the Security and Policy Conference of the Institute for 
+Policy and Strategy Conference, Reichman University,” November 23, 2021. 
+
+Congressional Research Service 
+
+ 
+
+32 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+scenarios.”180 Bennett has stated a preference for no deal,181 but has said he does not intend to 
+fight publicly with U.S. officials about it.182 
+
+As international discussions around the JCPOA continued in March 2022, Bennett and Foreign 
+Minister Lapid issued a joint statement arguing against reports that the United States might 
+remove Iran’s Islamic Revolutionary Guard Corps (IRGC) from its Foreign Terrorist 
+Organizations list in exchange for a promise not to harm Americans.183 In an April 26, 2022, 
+Senate Foreign Relations Committee hearing, Secretary Blinken said that he could only envision 
+the IRGC’s de-listing if Iran takes steps necessary to justify it.184 On May 4, 62 Senators voted in 
+favor of a motion that any Iran nuclear deal must address Iran’s ballistic missile program, support 
+for terrorism, and oil trade with China, and not lift sanctions on or de-list the IRGC.185 Later in 
+May, Bennett claimed that President Biden told him in April that he would not de-list the 
+IRGC.186 
+
+Various sources document reported Israeli covert or military operations targeting Iran’s nuclear 
+program,187 and some U.S. officials have reportedly differed with Israeli counterparts on the 
+overall effectiveness of such operations.188 In between his August 2021 White House meetings 
+with Prime Minister Bennett, President Biden said that the United States will first use diplomacy 
+to “ensure Iran never develops a nuclear weapon,” but if that fails, “we’re ready to turn to other 
+options.”189 In a September 2021 interview, Defense Minister Gantz suggested that he would be 
+prepared to accept a U.S. return to the JCPOA, while also calling for a “viable, U.S.-led plan B” 
+to pressure Iran in case negotiations are unsuccessful, and alluding to Israeli military contingency 
+plans.190 
+
+As of May 2022, one source reported that divisions persist among Israeli officials over which 
+approach or combination of approaches—among options including international diplomacy, U.S.-
+led sanctions, and Israeli military and intelligence operations—may be likelier to prevent or slow 
+Iranian nuclear advances.191 Some sources allude to upgrades in Israeli military capabilities,192 but 
+
+ 
+180 Barak Ravid, “Scoop: Israel’s military intel chief says Iran deal better than no deal,” Axios , January 5, 2022. 
+181 Jonathan Lis, “Bennett Announces Laser-based Missile Defense System ‘Within a Year,’” haaretz.com, February 1, 
+2022. 
+
+182 “Bennett says he won’t pick public fight with US over Iran nuclear deal,” Times of Israel , March 21, 2022. 
+183 Israeli Prime Minister’s Office, “Joint Announcement from PM Bennett and Foreign Minister Yair Lapid,” March 
+18, 2022. 
+
+184 Transcript available at http://www.cq.com/doc/congressionaltranscripts-6518577?11. 
+185 H.R. 4521, Roll Call Vote #155: Motion Agreed to 62-33, R 46-1, D 15-31, I 1-1, May 4, 2022; Congressional 
+Record , S.2321, May 4, 2022. 
+
+186 Jacob Magid, “Bennett: Biden notified me last month of decision to keep Iran Guards on terror list,” Times of Israel , 
+May 25, 2022. 
+
+187 “Iran foils Israel-linked ‘sabotage’ plot at nuclear plant,” Agence France Presse , March 15, 2022. 
+188 David E. Sanger et al., “Israeli Attacks Spur Upgrade of Iran Sites,” New York Times , November 22, 2021. 
+189 White House, “Remarks by President Biden and Prime Minister Bennett of the State of Israel Before Expanded 
+Bilateral Meeting,” August 27, 2021. 
+
+190 Neri Zilber, “Israel Can Live with a New Iran Nuclear Deal, Defense Minister Says,” foreignpolicy.com, September 
+14, 2021. 
+
+191 Ben Caspit, “Israeli leadership divided on Iran deal,” Al-Monitor , May 27, 2022. 
+192 “Israel makes dramatic upgrades to military plans to attack Iran,” jpost.com (citing Walla!), June 8, 2022. 
+
+Congressional Research Service 
+
+ 
+
+33 
+
+ 
+ link to page 52 Israel: Background and U.S. Relations 
+
+ 
+
+questions apparently remain about military readiness for a major operation against Iran’s nuclear 
+program.193 
+
+ Syria 
+
+In the early years of the Syria conflict, Israel primarily employed airstrikes to prevent Iranian 
+weapons shipments destined for Hezbollah in Lebanon. Later, as the government of Bashar al 
+Asad reacquired control of large portions of Syria’s territory, Israeli leaders expressed intentions 
+to prevent Iran from constructing and operating bases or advanced weapons manufacturing 
+facilities in Syria. According to a March 2022 report, since 2017 Israel’s air force has struck at 
+least 1,200 targets in Syria using around 5,500 munitions.194 In 2021, the deployment of some 
+Iranian air defense systems in Syria prompted Israel to start sending larger aircraft formations to 
+reduce the chances of having an aircraft downed.195 In 2021, Iran-backed forces attacked the 
+small U.S. military base at Al Tanf in southern Syria, ostensibly in response to Israeli airstrikes.196 
+The base is in a position to block supply lines to Hezbollah in Lebanon and otherwise disrupt 
+Iran’s regional operations.197 
+
+After several years of conflict in Syria, in 2019 the United States recognized Israeli sovereignty 
+over the Golan Heights, a territory Israel captured from Syria during the 1967 Arab-Israeli war. 
+For more information, se e Appendix C . 
+
+Russia’s advanced air defense systems in Syria could affect Israeli operations there.198 Russia has 
+reportedly shown some capacity to thwart Israeli airstrikes against Iranian or Syrian targets,199 but 
+has generally refrained via a deconfliction mechanism with Israel.200 This deconfliction has 
+apparently continued to date even with Russia’s war in Ukraine, but Russia has criticized some 
+Israeli strikes.201 In May 2022, a Russian-origin S-300 air defense system in Syria reportedly fired 
+on Israeli jets for the first time, raising questions about the status of Israel-Russia deconfliction.202 
+
+ Hezbollah in Lebanon 
+
+Lebanese Hezbollah is Iran’s closest and most powerful nonstate ally in the region. Hezbollah’s 
+forces and Israel’s military have sporadically clashed near the Lebanese border for decades—with 
+the antagonism at times contained in the border area, and at times escalating into broader 
+
+ 
+193 Amos Harel, “Israel’s Saber-rattling on Iran Lacks One Critical Element,” haaretz.com, May 20, 2022. 
+194 Anna Ahronheim, “Thousands of airstrikes carried out by Israel in past five years,” jpost.com, March 29, 2022. 
+195 Anna Ahronheim, “Iran has used advanced air defense batteries against Israel in Syria,” jpost.com, March 7, 2022. 
+196 “Iranian Attack on U.S. Base Was Vengeance for Israeli Attacks in Syria, Report Says,” haaretz.com, November 19, 
+2021. 
+
+197 Seth J. Frantzman, “Why the attack on America’s Tanf base in Syria matters – analysis,” jpost.com, October 21, 
+2021. 
+
+198 Paul Iddon, “Is Russia Helping Syria Intercept Israeli Missile Strikes?” forbes.com, July 30, 2021. 
+199 Arie Egozi, “Israel Shifts to Standoff Weapons in Syria as Russian Threats Increase,” Breaking Defense , July 27, 
+2021. 
+
+200 Jacob Magid, “Russia says military coordination with Israel in Syria will continue as usual,” Times of Israel , 
+February 27, 2022. 
+
+201 Anna Ahronheim, “Israel to increase military, civilian aid to Ukraine – report,” jpost.com, May 4, 2022. 
+202 Dan Parsons and Tyler Rogoway, “S-300 Surface-To-Air Missile Fired at Israeli Jets over Syria for First Time: 
+Report,” The Drive , May 16, 2022. 
+
+Congressional Research Service 
+
+ 
+
+34 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+conflict.203 Speculation persists about the potential for wider conflict and its implications, 
+including from incursions into Israeli airspace by Hezbollah drones.204 
+
+Israeli officials have sought to draw attention to Hezbollah’s buildup of mostly Iran-supplied 
+weapons—including reported upgrades to the range, precision, and power of its projectiles—and 
+its alleged use of Lebanese civilian areas as strongholds.205 In early 2022, Hezbollah’s leadership 
+and Israel’s defense ministry both publicly cited Iran-backed efforts by Hezbollah to manufacture 
+precision-guided missiles in Lebanon.206 
+
+ Palestinian Militants and Gaza 
+
+Israel faces an ongoing threat from the Gaza Strip, mainly from the militant groups Hamas and 
+PIJ, which both receive assistance from Iran.207 Although Palestinian militants maintain rocket 
+and mortar arsenals, Israel’s Iron Dome defense system has diminished the threats they pose.208 
+Systematic Israeli efforts, with some financial and technological assistance from the United 
+States, have largely neutralized tunnels that Palestinian militants used somewhat effectively in a 
+2014 conflict with Israel.209 Additionally, in December 2021 Israel completed an above- and 
+below-ground barrier running the length of its boundary with Gaza to complement a border fence 
+that Egypt built along its border with Gaza in 2020.210 
+
+ Arab States 
+
+ The Abraham Accords 
+
+In late 2020 and early 2021, Israel reached agreements to normalize or improve its relations with 
+four members of the Arab League: the UAE, Bahrain, Morocco, and Sudan. The Trump 
+Administration facilitated each of these agreements, known as the Abraham Accords, and (as 
+mentioned above) provided U.S. security, diplomatic, or economic incentives for most of the 
+countries in question.211 In connection with the agreements, the UAE and Sudan formally ended 
+
+ 
+203 CRS Report R44759, Lebanon , by Carla E. Humud; CRS In Focus IF10703, Lebanese Hezbollah , by Carla E. 
+Humud. 
+
+204 Orna Mizrahi and Yoram Schweitzer, “Hezbollah’s Efforts to Restore its Domestic Standing: The Israeli Card,” 
+Institute for National Security Studies, March 9, 2022. 
+
+205 See, e.g., “Hezbollah says it has doubled its arsenal of guided missiles,” Associated Press , December 28, 2020; Ben 
+Hubbard and Ronen Bergman, “Who Warns Hezbollah That Israeli Strikes Are Coming? Israel,” New York Times , 
+April 23, 2020. 
+
+206 “Hezbollah claims it’s making drones and missiles in Lebanon; chief offers export opportunity,” Associated Press , 
+February 16, 2022; Israeli Government Press Office, “DM Gantz Signs Seizure Order Against Lebanese Companies 
+Supplying Hezbollah Project,” February 6, 2022. 
+
+207 For more information, see CRS Report RL34074, The Palestinians: Background and U.S. Relations , by Jim Zanotti. 
+208 Sebastien Roblin, “How Hamas’ Arsenal Shaped the Gaza War of May 2021,” forbes.com, May 25, 2021. For more 
+on Iron Dome, see CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. 
+
+209 CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy M. Sharp. 
+210 Gross, “‘A wall of iron, sensors and concrete’: IDF completes tunnel-busting Gaza barrier”; Adam Khalil, “Egypt 
+building new wall along Gaza border,” Middle East Eye , February 18, 2020. 
+
+211 These incentives included possible U.S. arms sales to the UAE and Morocco, possible U.S. and international 
+economic assistance or investment financing for Morocco and Sudan, and U.S. recognition of Morocco’s claim of 
+sovereignty over the disputed territory of Western Sahara. Some reports suggest that the Trump Administration linked 
+Sudan’s removal from the U.S. state sponsors of terrorism list to its agreement to recognize Israel. 
+
+Congressional Research Service 
+
+ 
+
+35 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+their participation in the decades-long Arab League boycott of Israel.212 Morocco and Bahrain had 
+previously done so. In 2021, Israel opened embassies in the UAE and Bahrain, and both countries 
+reciprocated. Israel and Morocco also reopened the liaison offices that each country had operated 
+in the other from the mid-1990s to 2000. Saudi Arabia reportedly supported the UAE and Bahrain 
+in their decisions to join the Abraham Accords, even allowing the use of Saudi airspace for direct 
+commercial airline flights between those countries and Israel.213 
+
+Trade, tourism, and investment ties have generally deepened since the signing of the Accords—
+including a May 2022 Israel-UAE free-trade agreement (pending Israeli ratification) and a major 
+Israel-UAE-Jordan initiative focused on desalinated water and solar energy.214 One exception is 
+that implementing Israel-Sudan normalization appears to be on hold following the Sudanese 
+military’s seizure of power in October 2021.215 As a sign of mutual high-level commitment to the 
+Accords, Secretary of State Blinken met Israeli Foreign Minister Lapid and the foreign ministers 
+of the UAE, Bahrain, Morocco, and Egypt at a March 2022 summit in Israel’s southern Negev 
+desert. 
+
+U.S. and Israeli officials seek to expand the Abraham Accords to include other Arab and Muslim-
+majority countries. Commemorating the one-year anniversary of the Israel-UAE-Bahrain 
+agreements in October 2021, Secretary Blinken said that “we’re committed to continue building 
+on the efforts of the last administration to expand the circle of countries with normalized relations 
+with Israel in the years ahead.”216 However, the Biden Administration appetite for offering major 
+U.S. policy inducements to countries in connection with normalization efforts remains unclear.217 
+The Biden Administration also has sought to avoid portraying Israeli normalization with Arab and 
+Muslim-majority states as a substitute for efforts toward a negotiated two-state solution to the 
+Israeli-Palestinian conflict.218 Palestinian leaders denounced the initial announcement of UAE 
+normalization with Israel as an abandonment of the Palestinian national cause, given Arab League 
+states’ previous insistence that Israel address Palestinian negotiating demands as a precondition 
+for improved ties.219 
+
+ 
+212 Jon Gambrell, “UAE formally ends Israel boycott amid US-brokered deal,” Associated Press , August 29, 2020; 
+“Sudan officially annuls 63-year Israel boycott law,” Times of Israel , April 19, 2021. 
+213 Barak Ravid, “Scoop: Jake Sullivan discussed Saudi-Israel normalization with MBS,” Axios , October 20, 2021. 
+214 “Israel-UAE economic relations grow further with free trade agreement,” Al-Monitor , May 31, 2022; “Israel, Jordan 
+sign huge UAE-brokered deal to swap solar energy and water,” Times of Israel , November 22, 2021. 
+
+215 Testimony of Assistant Secretary of State for African Affairs Molly Phee, “Sudan’s Imperiled Transition: U.S. 
+Policy in the Wake of the October 25th Coup,” Senate Foreign Relations Committee, hearing, February 1, 2022. 
+216 State Department, “Secretary Antony J. Blinken and Israeli Alternate Prime Minister and Foreign Minister Yair 
+Lapid and United Arab Emirates Foreign Minister Sheikh Abdullah Bin Zayed Al Nahyan at a Joint Press 
+Availability,” October 13, 2021. 
+
+217 Michael Koplow et al., “Biden has an opportunity to put his own stamp on Arab-Israeli relations,” The Hill , October 
+14, 2021. 
+
+218 State Department, “Secretary Antony J. Blinken Joint Press Statements at the Conclusion of the Negev Summit,” 
+March 28, 2022. 
+
+219 Walid Mahmoud and Muhammad Shehada, “Palestinians unanimously reject UAE-Israel deal,” Al Jazeera , August 
+14, 2020. 
+
+Congressional Research Service 
+
+ 
+
+36 
+
+ 
+ link to page 18 Israel: Background and U.S. Relations 
+
+ 
+
+ The Pathway to the Abraham Accords 
+
+Before the Abraham Accords, Egypt and Jordan had been the only Arab states with formal diplomatic relations 
+with Israel.220 In 1981, Saudi Arabia’s then-Crown Prince Fahd bin Abd al Aziz Al Saud proposed a formula—later 
+enshrined in the 2002 Arab Peace Initiative—under which Israel was expected to make certain concessions, 
+including on Palestinian statehood, before Arab states would normalize their relations with it.221 After Israel 
+started negotiating directly with the Palestinians in the 1990s, it established limited diplomatic relations with 
+Morocco, and informal ties with a number of other Arab states, including the UAE and Bahrain.222 These countries 
+downgraded their ties with Israel after the onset of the second Palestinian intifada in 2000. 
+However, since the early 2010s discreet Israeli links with Arab states became closer and more public on issues 
+including intelligence, security, and trade. Israel has worked with some Arab states to counter common 
+geopolitical concerns, such as Iran’s regional influence and military capabilities and Sunni Islamist populist 
+movements (including various Muslim Brotherhood branches and affiliates).223 Controversy surfaced in 2021 over 
+the possible past use of spyware from the Israel-based company NSO Group by several countries throughout the 
+world, reportedly including the UAE, Bahrain, Morocco, and Saudi Arabia (all four countries publicly said that 
+allegations of spyware use were unfounded).224 
+To cement its normalization of relations with the UAE, Israel agreed in August 2020 to suspend plans to annex 
+part of the West Bank, with one source stating that the UAE received a commitment from U.S. (Trump 
+Administration) officials that they would not approve Israeli annexation until at least January 2024.225 Palestinian 
+leaders claimed that the UAE legitimized Israel’s annexation threats by bargaining over them, and thus acquiesced 
+to a West Bank status quo that some observers label “de facto annexation.”226 UAE officials countered that by 
+significantly delaying Israeli declarations of sovereignty over West Bank areas, they preserved prospects for future 
+negotiations toward a Palestinian state.227 
+Other Arab state leaders considering entering into or maintaining normalization with Israel might gauge whether 
+expected benefits would outweigh concerns about popular criticism or unrest they might face for possibly 
+undermining the Palestinian cause.228 Normalization efforts to date have not triggered significant unrest, but 
+outside insight is limited into public opinion, its drivers, and how popular reactions are shaped by the nature of 
+authoritarian Arab regimes. 
+
+ Prospects for Saudi normalization. As Israel has drawn closer to some Arab states, the 
+likelihood of a future normalization between Israel and Saudi Arabia may be increasing. Given 
+Saudi Arabia’s importance as an economic and military power in the region, the kingdom’s 
+history of firm opposition to such normalization, and its status as the custodian of Islam’s most 
+holy and foundational sites, such a development could boost any precedent that the Abraham 
+
+ 
+220 Egypt and Israel signed a peace treaty in 1979, and Jordan and Israel did the same in 1994. 
+221 See footno te 67. 
+ 222 Miriam Berger, “Israel’s relations in the Middle East, explained,” washingtonpost.com, August 15, 2020; Adam 
+Entous, “Donald Trump’s New World Order,” New Yorker, June 11, 2018; CRS Report 95-1013, Bahrain: Issues for 
+U.S. Policy , by Kenneth Katzman. 
+
+223 Steve Hendrix, “Inside the secret-not-secret courtship between Israel and the United Arab Emirates,” 
+washingtonpost.com, August 14, 2020; CRS Report 95-1013, Bahrain: Issues for U.S. Policy , by Kenneth Katzman. 
+
+224 Ronen Bergman and Mark Mazzetti, “The Battle for the World’s Most Powerful Cyberweapon,” New York Times 
+Magazine , January 28, 2022; “Saudi Arabia And UAE Deny Pegasus Spyware Allegations,” Agence France Presse , 
+July 22, 2021; “Morocco says it will investigate ‘unfounded allegations’ on spyware,” Reuters , July 21, 2021; Thomas 
+Brewster, “NSO iPhone Spyware Hacks Bahrain Activists In The U.K., Report Claims,” forbes.com, August 24, 2021. 
+225 Jacob Magid, “US assured UAE it won’t back Israel annexation before 2024 at earliest, ToI told,” Times of Israel , 
+September 13, 2020. 
+
+226 Walid Mahmoud and Muhammad Shehada, “Palestinians unanimously reject UAE-Israel deal,” Al Jazeera , August 
+14, 2020. 
+
+227 “UAE minister: We bought lot of time on annexation; Palestinians should negotiate,” Times of Israel , August 14, 
+2020. 
+
+228 See, e.g., Jared Malsin and Amira al-Fekki, “Egypt’s ‘Cold Peace’ a Harbinger for Region,” Wall Street Journal , 
+December 17, 2020. 
+
+Congressional Research Service 
+
+ 
+
+37 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+Accords may set for other Muslim-majority countries considering cooperation with Israel.229 In 
+June 2022, Secretary Blinken said that Saudi Arabia is a “critical partner” of the United States in 
+dealing with regional challenges from extremism and Iran and in “continuing the process of 
+building relationships between Israel and its neighbors both near and further away through the 
+continuation, the expansion of the Abraham Accords.”230 
+
+While senior Saudi officials say that full Israel-Saudi normalization still remains contingent on 
+progress with Palestinian issues,231 the two countries are reportedly engaging in serious talks in 
+the meantime to build business ties and coordinate on regional security matters. Top Israeli and 
+Saudi officials say that the countries could take certain incremental steps toward eventual 
+normalization irrespective of the Palestinian question.232 Future steps could include the expansion 
+of Israel’s transit privileges through Saudi airspace, and Saudi Arabia’s full assumption of control 
+and security responsibility for the Red Sea islands Tiran and Sanafir from Egypt.233 One Israeli 
+journalist has argued that in talks regarding the two islands, U.S. officials are essentially 
+encouraging Israel to agree to a weakening of security protocols from the 1979 Israel-Egypt peace 
+treaty in exchange for a future and still unclear hope of Israeli-Saudi normalization.234 
+
+ Security cooperation. In January 2021, President Trump determined that U.S. Central Command 
+(CENTCOM), which commands U.S. military forces in most countries in the Middle East, would 
+add Israel to its area of responsibility, partly to encourage military interoperability as a means of 
+reinforcing closer ties between Israel and many Arab states.235 Israel had previously been under 
+the purview of U.S. European Command. CENTCOM formalized Israel’s move in September 
+2021,236 and in October an Israeli Defense Forces liaison was stationed at CENTCOM 
+headquarters.237 Since then, Israel has joined military exercises with the United States and the 
+other Abraham Accords states, as well as other CENTCOM partners such as Saudi Arabia, Oman, 
+Jordan, Egypt, and Pakistan.238 
+
+Following a string of missile and drone attacks against the UAE in early 2022, apparently by 
+Iran-allied forces in Yemen (known as the Houthis), the UAE government has reportedly 
+expressed interest in closer security cooperation with Israel.239 Earlier, both Morocco (November 
+2021) and Bahrain (February 2022) signed MOUs with Israel on security cooperation.240 These 
+
+ 
+229 Dion Nissenbaum, “Saudis Expand Talks with Israel,” Wall Street Journal , June 7, 2022. 
+230 State Department, “Secretary Antony J. Blinken at the Foreign Affairs Magazine Centennial Celebration,” June 1, 
+2022. 
+
+231 “Saudi foreign minister reiterates Kingdom’s position on Israel,” Arab News , May 24, 2022. 
+232 Nissenbaum, “Saudi Arabia Moves Toward Eventual Ties with Israel.” 
+233 Ibid.; Barak Ravid, “Scoop: U.S. negotiating deal among Saudis, Israelis and Egyptians,” Axios , May 23, 2022. 
+234 Amos Harel, “In UAE, Bennett Inches Closer to the Biggest Prize of All,” haaretz.com, June 10, 2022. 
+235 Jared Szuba, “Trump orders US Central Command to include Israel amid strategic shift,” Al-Monitor , January 15, 
+2021. 
+
+236 U.S. Central Command, “U.S. Central Command Statement on the Realignment of the State of Israel,” September 1, 
+2021. 
+
+237 Judah Ari Gross, “IDF liaison sets up shop in US CENTCOM offices in Florida, solidifying move,” The Times of 
+Israel , October 29, 2021. 
+
+238 “UAE, Bahrain, Israel and U.S. forces in first joint naval drill,” Reuters , November 11, 2021. Participant list for 
+2022 International Maritime Exercise available at https://www.dvidshub.net/graphic/18822/imx-ce-22-participant-list. 
+
+239 Arie Egozi, “Amid attacks, UAE quietly asks Israel about defense systems: Sources,” Breaking Defense , January 25, 
+2022. 
+
+240 Ben Caspit, “Gantz says Israel, Morocco ‘leap together’ in historic agreement,” Al-Monitor , November 26, 2021; 
+Rina Bassist, “Israel signs security cooperation agreement with Bahrain,” Al-Monitor , February 3, 2022. During the 
+
+Congressional Research Service 
+
+ 
+
+38 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+MOUs appear to anticipate more intelligence sharing, joint exercises and training, and arms sales. 
+In his February 8, 2022, confirmation hearing before the Senate Armed Services Committee, 
+then-nominee as CENTCOM Commander (then-) Lieutenant General Michael Kurilla testified 
+that Israel and other regional countries were cooperating on integrated air and missile defense and 
+in other security areas. At the March 2022 Negev summit, Israeli leaders and their Arab 
+counterparts reportedly discussed a range of possible cooperative measures, such as real-time 
+intelligence sharing on inbound drone and missile threats and acquisition of Israeli air defense 
+systems.241 
+
+ Selected congressional actions. In January 2022, some Members of the Senate and House 
+formed bipartisan caucuses to promote the Abraham Accords.242 In March, Congress enacted the 
+Israel Relations Normalization Act of 2022 (IRNA, Division Z of P.L. 117-103). Among other 
+things, the IRNA requires the Secretary of State to submit an annual strategy for strengthening 
+and expanding normalization agreements with Israel, and an annual report on the status of 
+measures within Arab League states that legally or practically restrict or discourage normalization 
+efforts with Israel or domestic support for such efforts. 
+
+In June 2022, several Members in the Senate and House introduced the Deterring Enemy Forces 
+and Enabling National Defenses (DEFEND) Act of 2022. The bill would require the Secretary of 
+Defense to submit a strategy and feasibility study on cooperation with Gulf Cooperation Council 
+states, Iraq, Israel, Jordan, and Egypt for an integrated air and missile defense capability to 
+counter Iran-related threats. 
+
+ Outlook. Common cause between Israel and other Abraham Accords states could intensify, 
+dwindle, or fluctuate depending on global and regional political and economic trends. Questions 
+include: 
+
+ What types of military cooperation do Arab states seek with Israel as they 
+
+consider the benefits and drawbacks of either deterring or accommodating Iran? 
+
+ What other political and economic factors, including the regional roles of China 
+
+and Russia, could influence the future of the Abraham Accords and cooperation 
+among its participants? 
+
+ How might the Abraham Accords countries influence Palestinian issues? 
+ How likely are Saudi Arabia and other countries to normalize relations with 
+
+Israel, and under what conditions? What benefits and drawbacks might result 
+from U.S. incentives for normalization? 
+
+ Arab-Israeli Regional Energy Cooperation 
+
+Israel’s offshore natural gas deposits have provided additional opportunities for it to build 
+economic connections with its Arab neighbors. Israel’s 15-year export deals with Egypt and 
+Jordan—using gas from its Leviathan field—took effect in 2020.243 These deals have reinforced a 
+
+ 
+same visit in which Israeli Defense Minister Benny Gantz signed the MOU with Bahrain, he and Bahrain’s defense 
+minister made a public visit to the U.S. Navy’s 5th Fleet base there to emphasize the level of collaboration among all 
+parties involved. 
+
+241 “Israel reportedly working on air defense pact with regional allies,” Times of Israel , March 29, 2022. 
+242 For more information, see https://www.rosen.senate.gov/sites/default/files/2022-
+01/Senate%20Abraham%20Accords%20Caucus%20Mission%20Statement.pdf. 
+
+243 Aidan Lewis and Ari Rabinovitch, “Israel starts exporting natural gas to Egypt under landmark deal,” Reuters , 
+January 15, 2020; Suleiman Al-Khalidi, “Jordan gets first natural gas supplies from Israel,” Reuters , January 1, 2020. 
+
+Congressional Research Service 
+
+ 
+
+39 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+longstanding dynamic in which Egyptian and Jordanian government-to-government cooperation 
+with Israel occurs amid some degree of popular domestic opposition, due to the history of Arab-
+Israeli conflict and the Palestinian issue. 
+
+Some of the gas covered by Israel’s export agreement with Egypt is flowing via pipeline to 
+Egypt’s two LNG liquefaction facilities.244 Israel appears to be seriously considering new onshore 
+and subsea pipelines that could increase supply to the LNG facilities.245 These could help make 
+Egypt a hub for regional exports to Europe.246 In June 2022, Israel signed a trilateral MOU with 
+Egypt and the European Union stipulating that the parties will work together to send natural gas 
+to EU member states via Egyptian LNG infrastructure.247 
+
+ Turkey 
+ Israel and Turkey have shown signs of improving ties over the past year. The two countries 
+maintain diplomatic relations but have not had ambassadors stationed in each other’s country 
+since 2018. Their relations have been troubled since the late 2000s, based on disagreements over 
+Palestinian issues and Turkey’s support for Hamas, though the countries have continued to 
+expand trade ties.248 
+
+Israeli openness to rapprochement with Turkey may stem from a confluence of factors, including 
+
+ Potentially greater Turkish willingness to reduce its support for Hamas in hopes 
+
+of better political and economic relations with Israel and other key U.S. partners 
+in the region (Sunni Arab governments such as the UAE and Saudi Arabia)—
+partly to improve Turkey’s image in Washington. Some reports from early 2022 
+hint at Turkey’s willingness to expel Hamas members allegedly involved in 
+militant operations from its territory.249 
+
+ Increasing Israeli focus on how relations with Turkey and other regional 
+
+countries might help counter Iran. 
+
+ The 2021 leadership change from the Netanyahu government to the Bennett-
+
+Lapid power-sharing government. 
+
+In March 2022, Israeli President Herzog visited Turkey. In May, Turkish Foreign Minister Mevlut 
+Cavusoglu visited Israel (and the West Bank), and the two countries anticipate future bilateral 
+meetings and steps to improve political and economic relations. Turkish President Recep Tayyip 
+Erdogan and other top Turkish officials have made public statements expressing interest in energy 
+cooperation with Israel. However, Israeli officials reportedly remain skeptical about prospects for 
+a subsea Israel-Turkey natural gas pipeline.250 While Israel has pursued greater high-level 
+
+ 
+244 “Israel to boost natural gas export to Egypt by up to 50 pct this month,” Bloomberg , February 15, 2022. 
+245 Ron Bousso and Ari Rabinovitch, “Israel considering new pipeline to boost gas exports to Egypt,” Reuters , October 
+21, 2021. 
+
+246 David O’Byrne, “No magic tap for Europe to replace Russian gas via Turkey,” Al-Monitor , March 17, 2022. 
+247 Rina Bassist, “Israeli energy minister inks deal to export gas to Europe via Egypt,” Al-Monitor , June 15, 2022. 
+248 Kemal Kirisci and Dan Arbell, “President Herzog’s visit to Ankara: A first step in normalizing Turkey-Israel 
+relations?” Brookings Institution, March 7, 2022. 
+
+249 Ariel Kahana, “Report: Israel, Turkey working to deport Hamas officials from Ankara,” Israel Hayom , February 15, 
+2022; Ofer Bengio, “Turkey Finds Israel Useful Again,” Tablet , March 13, 2022. 
+250 Lazar Berman, “FM’s visit shows Turkey eager to accelerate reconciliation, but Israel more cautious,” Times of 
+Israel , May 24, 2022. While such a pipeline may be the most feasible pipeline option for transporting Eastern 
+Mediterranean natural gas to Europe, political and economic obstacles may make liquefied natural gas (LNG) exports 
+
+Congressional Research Service 
+
+ 
+
+40 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+interaction with Turkey, it may be cautious about significant near-term improvements in bilateral 
+relations, and appears to remain committed to close strategic ties with Greece and the Republic of 
+Cyprus251—countries with which Turkey has long-standing historical, ethnoreligious, territorial, 
+and maritime boundary disputes. 
+
+ China: Investments in Israel and U.S. Concerns252 
+ U.S. officials have raised concerns with Israel over burgeoning Chinese investments in Israeli 
+high-tech companies and civilian infrastructure.253 Israel-China investment ties have grown since 
+China announced its Belt and Road Initiative in 2013,254 with Israel as an attractive hub of 
+innovation for Chinese partners, and China as a huge potential export market and source of 
+investment for Israeli businesses.255 
+
+Closer Israel-China economic relations have led to official U.S. expressions of concern,256 
+apparently focused on the possibility that China might gather intelligence or acquire technologies 
+with the potential to threaten U.S. national security in such fields as cybersecurity, artificial 
+intelligence, satellite communications, and robotics. Previously, China-Israel defense industry 
+cooperation in the 1990s and 2000s contributed to tension in the U.S.-Israel defense relationship 
+and to an apparent de facto U.S. veto over Israeli arms sales to China.257 Partly due to U.S. 
+concerns regarding China’s involvement in Israel’s economy, Israel created an advisory panel on 
+foreign investment in Israel in late 2019.258 However, this panel reportedly does not have the 
+authority to review investments in sectors such as high-tech that accounted for most of China’s 
+investments in Israel in the previous decade.259 According to a 2021 study by Israel’s Institute for 
+National Security Studies 
+
+Chinese investments, especially in the high-tech sector, did indeed show progressive 
+growth both in number and scale, especially between 2014 and their peak in 2018. 
+However, in 2019 and 2020 the pendulum swung again, as China slowed its penetration 
+into the Israeli economy, just as it did elsewhere in the world. The reasons for this were a 
+
+ 
+from liquefaction terminals in Egypt a more practical option. “Turkey best option for East Med gas transit to Europe: 
+Experts,” Daily Sabah , March 10, 2022; Sean Mathews, “Russia-Ukraine war: Conflict boosts hopes for East 
+Mediterranean energy, experts say,” Middle East Eye , April 5, 2022. 
+
+251 “Summit in Ankara: Turkey is wooing a reluctant Israel,” Americans for Peace Now, March 14, 2022. 
+252 For background on past U.S. concerns regarding Israeli defense transactions with China, see CRS Report RL33476, 
+ Israel: Background and U.S. Relations , by Jim Zanotti; CRS Report RL33222, U.S. Foreign Aid to Israel , by Jeremy 
+M. Sharp. 
+
+253 Shira Efron et al., Chinese Investment in Israeli Technology and Infrastructure: Security Implications for Israel and 
+the United States , RAND Corporation, 2020; Shira Efron et al., The Evolving Israel-China Relationship , RAND 
+Corporation, 2019; Jewish Institute for National Security of America, Countering Chinese Engagement with Israel: A 
+Comprehensive and Cooperative U.S.-Israeli Strategy , February 2021. 
+
+254 For more information on the Belt and Road Initiative, see CRS Report R45898, U.S.-China Relations , coordinated 
+by Susan V. Lawrence. 
+
+255 Danny Zaken, “Chinese-operated port opens in Israel despite American concerns,” Al-Monitor , September 9, 2021. 
+256 Ron Kampeas, “Breaking China: A rupture looms between Israel and the United States,” Jewish Telegraphic 
+Agency , June 2, 2020. 
+
+257 Efron et al., The Evolving Israel-China Relationship , 2019, pp. 15-20. In late 2021, three Israeli companies and 10 
+suspects were indicted on charges of exporting cruise missiles to China without a permit. “10 Israelis set to be Indicted 
+for Illegally Exporting Missiles to China,” Times of Israel , December 20, 2021. 
+258 Arie Egozi, “Israelis Create Foreign Investment Overseer; China Targeted,” Breaking Defense, November 13, 2019. 
+259 Efron et al., Chinese Investment in Israeli Technology , 2020, pp. 24-25. 
+
+Congressional Research Service 
+
+ 
+
+41 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+combination of changes in domestic Chinese priorities regarding the export of capital out 
+of the country and external causes, such as the coronavirus pandemic and a less inviting 
+climate for Chinese investments due to American pressure.260 
+
+Additionally, U.S. officials have made notable efforts to discourage Chinese involvement in 
+specific Israeli infrastructure projects. After reported warnings from the Trump Administration, 
+Israeli officials apparently blocked Chinese companies from working on Israeli communications 
+infrastructure such as 5G.261 U.S. concerns may have influenced Israel’s finance ministry to reject 
+a bid in 2020 from a Hong Kong-linked company to build a major desalination plant.262 
+
+Additionally, the U.S. Navy reportedly reconsidered its practice of periodically docking at the 
+Israeli naval base in Haifa, because a state-owned Chinese company (the Shanghai International 
+Port Group) secured the contract to operate a new terminal at Haifa’s seaport for 25 years.263 This 
+terminal opened in September 2021.264 Biden Administration officials have reportedly pressed 
+Israeli counterparts to regularly check heavy machinery at the port for technology that could be 
+employed to spy on the nearby Israeli naval base.265 Other state-owned Chinese companies are 
+developing a new port in Ashdod (which also hosts an Israeli naval base), and taking part in 
+construction for Tel Aviv’s light rail system and road tunnels in Haifa.266 
+
+In early 2022, an Israeli official was cited as saying that Israel has agreed to “update Washington 
+about any major deals with Beijing, especially in infrastructure and technology,” and “would 
+reconsider any such deals at America’s request.”267 
+
+ 
+260 Doron Ella, Chinese Investments in Israel: Developments and a Look to the Future , Institute for National Security 
+Studies, February 1, 2021. 
+
+261 Hiddai Segev and Assaf Orion, “The Great Power Competition over 5G Communications: Limited Success for the 
+American Campaign against Huawei,” Institute for National Security Studies, March 3, 2020. 
+
+262 “Amid US pressure, Israel taps local firm over China for $1.5b desalination plant,” Times of Israel , May 26, 2020. 
+263 Roie Yellinek, “The Israel-China-U.S. Triangle and the Haifa Port Project,” Middle East Institute, November 27, 
+2018. Reportedly, the Israeli government planned to limit sensitive roles at the port to Israelis with security clearances. 
+Jack Detsch, “Pentagon repeats warning to Israel on Chinese port deal,” Al-Monitor , August 7, 2019. 
+264 Galia Lavi and Assaf Orion, “The Launch of the Haifa Bayport Terminal: Economic and Security Considerations,” 
+Institute for National Security Studies Insight No. 1516, September 12, 2021. 
+
+265 Arie Egozi, “US Presses Israel on Haifa Port amid China Espionage Concerns: Sources,” Breaking Defense , October 
+5, 2021. 
+
+266 Efron et al., The Evolving Israel-China Relationship, 2019, p. 38. 
+267 Lahav Harkov, “Israel Agrees to Update US About China Trade to Avoid Tension,” jpost.com, January 3, 2022. 
+
+Congressional Research Service 
+
+ 
+
+42 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Appendix A. Historical Background 
+
+ In General 
+ The modern quest for a Jewish homeland gathered momentum after the publication of Theodor 
+Herzl’s The Jewish State in 1896. Herzl was inspired by the concept of nationalism that had 
+become popular among various European peoples in the 19th century, and was also motivated by 
+European anti-Semitism. The following year, Herzl described his vision at the first Zionist 
+Congress, which encouraged Jewish settlement in Palestine, the territory that had included the 
+Biblical home of the Jews and was then part of the Ottoman Empire. 
+
+During World War I, the British government issued the Balfour Declaration, supporting the 
+“establishment in Palestine of a national home for the Jewish people.” Palestine became a British 
+Mandate after the war and British officials simultaneously encouraged the national aspirations of 
+the Arab majority in Palestine, insisting that its promises to Jews and Arabs did not conflict. Jews 
+immigrated to Palestine in ever greater numbers during the Mandate period, and tension between 
+Arabs and Jews and between each group and the British increased, leading to frequent clashes. 
+Following World War II, the plight of Jewish survivors of the Holocaust gave the demand for a 
+Jewish home added urgency, while Arabs across the Middle East concurrently demanded self-
+determination and independence from European colonial powers. 
+
+In 1947, the United Nations General Assembly developed a partition plan (Resolution 181(II)) to 
+divide Palestine into Jewish and Arab states, proposing U.N. trusteeship for Jerusalem and some 
+surrounding areas. The leadership of the Jewish Yishuv (or polity) welcomed the plan because it 
+appeared to confer legitimacy on the Jews’ claims in Palestine despite their small numbers. The 
+Palestinian Arab leadership and the League of Arab States (Arab League) rejected the plan, 
+insisting both that the specific partition proposed and the entire concept of partition were unfair 
+given Palestine’s Arab majority. Debate on this question prefigured current debate about whether 
+it is possible to have a state that both provides a secure Jewish homeland and is governed in 
+accordance with democratic values and the principle of self-determination. 
+
+After several months of violent conflict between Jews and Arabs, Britain officially ended its 
+Mandate on May 14, 1948, at which point the state of Israel proclaimed its independence and was 
+immediately invaded by Arab armies. During and after the conflict, roughly 700,000 Palestinians 
+were driven or fled from their homes, an occurrence Palestinians call the nakba 
+(“catastrophe”).268 Many became internationally designated refugees after ending up in areas of 
+Mandate-era Palestine controlled by Jordan (the West Bank) or Egypt (the Gaza Strip), or in 
+nearby Arab states. Palestinians who remained in Israel became Israeli citizens. 
+
+The conflict ended with armistice agreements between Israel and its neighboring Arab states: 
+Egypt, Jordan, Lebanon, and Syria. The territory controlled by Israel within these 1949-1950 
+armistice lines is roughly the size of New Jersey. Israel has engaged in further armed conflict with 
+neighbors on a number of occasions since then—most notably in 1956, 1967, 1973, and 1982. 
+Since the 1950s, Israel also has dealt with the threat of Palestinian guerrilla or terrorist attacks. In 
+1979, Israel concluded a peace treaty with Egypt, followed in 1994 by a peace treaty with Jordan, 
+thus making another multi-front war less likely. Nevertheless, security challenges persist from 
+Iran and groups allied with it, and from other developments in the Arab world. 
+
+ 
+268 CRS Report RL34074, The Palestinians: Background and U.S. Relations , by Jim Zanotti. 
+
+Congressional Research Service 
+
+ 
+
+43 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Political and Societal Evolution 
+ Israel’s society and politics have evolved since its founding. In the first decades, Israeli society 
+was dominated by secular Ashkenazi (Eastern European) Jews who constituted the large majority 
+of 19th- and early 20th-century Zionist immigrants. Many leaders from these immigrant 
+communities sought to build a country dedicated to Western liberal and communitarian values. 
+From 1948 to 1977, the social democratic Mapai/Labor movement led Israeli governing 
+coalitions. 
+
+The 1977 electoral victory of Menachem Begin’s more nationalistic Likud party helped boost the 
+influence of previously marginalized groups, particularly Mizrahi (Eastern) Jews who had 
+immigrated to Israel from Arab countries and Iran. This electoral result came at a time when 
+debate in Israel was intensifying over settlement in the territories occupied during the 1967 Arab-
+Israeli War. Begin and his successor in Likud, Yitzhak Shamir, helped drive the political agenda 
+over the following 15 years. Although Labor under Yitzhak Rabin later initiated the Oslo peace 
+process with the Palestinians, its political momentum slowed and reversed after Rabin’s 
+assassination in 1995. 
+
+Despite Labor’s setbacks, its warnings that high Arab birth rates could eventually make it difficult 
+for Israel to remain both a Jewish and a democratic state while ruling over the Palestinians gained 
+traction among many Israelis. However, after the initial peace process negotiations collapsed in 
+2000, the second Palestinian intifada (from 2000 to 2005) and conflicts with Hezbollah and 
+Hamas after Israeli withdrawals from southern Lebanon and the Gaza Strip strengthened the 
+right-of-center figures. They have led Israel since 2000 and have supported separation between 
+Israelis and Palestinians, while either opposing or placing significant conditions on negotiations. 
+
+Given the fragmentation of Israeli political parties under its electoral system, compromise among 
+diverse groups is a necessity for forming and maintaining a governing coalition. The system 
+generally gives smaller parties disproportionate influence on key issues important to their 
+constituents. For example, two Haredi (ultra-Orthodox Jewish) parties have joined several 
+governments in exchange for support on specific demands (i.e., subsidies and military exemptions 
+to support traditional lifestyles). Special treatment for Haredim is anathema to many voters 
+espousing more secular agendas, but the group comprises about 12% of the population and 
+current forecasts project it will grow to 32% by 2065.269 
+
+Arab Israelis make up nearly 20% of the population. Their experiences are generally different 
+from Jewish Israeli citizens in where and how they live, are educated, and socialize. While they 
+had been historically excluded from governing coalitions, the inclusion of the United Arab List 
+(UAL or Ra’am) in the current government suggests that Arab-led parties may have greater 
+leverage to seek benefits for their base constituents in exchange for joining future coalitions. 
+
+ 
+269 OECD Economic Surveys: Israel, September 2020. 
+
+Congressional Research Service 
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+
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+
+ 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Appendix B. Israeli Knesset Parties and Their 
+Leaders 
+
+ RIGHT 
+
+ Likud (Consolidation) – 30 Knesset seats (Opposition) 
+Israel’s historical repository of right-of-center nationalist ideology; skeptical of 
+territorial compromise; has also championed free-market policies. 
+ Leader: Binyamin Netanyahu 
+ Born in 1949, Netanyahu served as prime minister from 2009 to June 2021, and also 
+was prime minister from 1996 to 1999. Netanyahu served in an elite special forces 
+unit (Sayeret Matkal), and received his higher education at MIT. Throughout a career 
+in politics and diplomacy, he has been renowned both for his skepticism regarding the 
+exchange of land for peace with the Palestinians and his desire to counter Iran’s 
+
+ nuclear program and regional influence. He is generally regarded as both a 
+
+consummate political dealmaker and a security-minded nationalist. 
+Yisrael Beitenu (Israel Our Home) – 7 seats (Coalition) 
+Pro-secular, right-of-center nationalist party with base of support among Russian 
+speakers from the former Soviet Union. 
+ Leader: Avigdor Lieberman 
+Born in 1958, Lieberman is Israel’s finance minister, and has previously served as 
+defense minister and foreign minister. He is generally viewed as an ardent nationalist 
+and canny political actor with prime ministerial aspirations. Lieberman was born in 
+the Soviet Union (in what is now Moldova) and immigrated to Israel in 1978. He 
+worked under Netanyahu from 1988 to 1997. Disil usioned by Netanyahu’s 
+
+ wil ingness to consider concessions to the Palestinians, Lieberman founded Yisrael 
+
+Beitenu as a platform for former Soviet immigrants. He was acquitted of corruption 
+allegations in a 2013 case. 
+Yamina (Right) – 6 seats (4 Coalition/2 Opposition) 
+Right-of-center merger of three parties: New Right, Jewish Home, and National 
+Union; base of support among religious Zionists (mostly Ashkenazi Orthodox Jews); 
+includes core constituencies supporting West Bank settlements and annexation. One 
+party member (Idit Silman) does not support the governing coalition. 
+ Leader: Prime Minister Naftali Bennett (biography in text box in the main body of the report) 
+
+ 
+
+ New Hope (Tikva Hadasha) – 6 seats (Coalition) 
+New Hope is a party formed in 2020 as an alternative to Prime Minister Netanyahu 
+and Likud for mainstream right-wing voters. 
+ Leader: Gideon Sa’ar 
+Born in 1966, Sa’ar serves as justice minister. He served as cabinet secretary in the 
+1990s (for Prime Minister Netanyahu) and early 2000s (for Prime Minister Ariel 
+Sharon). He became an influential and popular member of Likud, first elected to the 
+
+ Knesset in 2003. He served as education minister from 2009 to 2013 and interior 
+
+minister from 2013 to 2014. After leaving the Knesset in 2014, he returned in 2019 
+but left Likud to form New Hope a year later. 
+
+Congressional Research Service 
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+
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+ 
+
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+
+ 
+
+ 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Religious Zionism (HaTzionut HaDatit) – 6 seats (Opposition) 
+Grouping of right-of-center parties including Religious Zionism/National Union-
+Tkuma, Otzma Yehudit, and Noam that formed for the March 2021elections. 
+ Leader: Bezalel Smotrich 
+Born in 1980, Smotrich has headed the underlying party that leads Religious Zionism 
+since 2019. A trained lawyer, he has engaged in regular activism to promote Jewish 
+nationalist and religiously conservative causes. 
+
+ 
+
+ LEFT 
+
+ Labor (Avoda) – 7 seats (Coalition) 
+ Labor is Israel’s historical repository of social democratic, left-of-center, pro-secular 
+Zionist ideology; associated with efforts to end Israel’s responsibility for Palestinians 
+
+in the West Bank and Gaza. 
+ Leader: Merav Michaeli 
+Born in 1966, Michaeli is transportation minister. She became Labor’s leader in 2020 
+
+ and was first elected to the Knesset in 2013. Before entering national politics, she 
+
+founded and headed an organization that supports victims of sexual assault, and was a 
+regular national media presence and university lecturer. 
+ Meretz (Vigor) – 6 seats (Coalition) 
+Meretz is a pro-secular Zionist party that supports initiatives for social justice and 
+peace with the Palestinians. 
+ Leader: Nitzan Horowitz 
+
+Born in 1965, Horowitz is health minister. He became Meretz’s leader in 2019 and 
+was first elected to the Knesset in 2009. He had a long career as a prominent 
+journalist before entering politics. 
+
+ 
+
+ CENTER 
+
+ Yesh Atid (There Is a Future) – 17 seats (Coalition) 
+Yesh Atid is a centrist party in existence since 2012 that has championed 
+socioeconomic issues such as cost of living and has taken a pro-secular stance. 
+ Leader: Yair Lapid 
+ Born in 1963, Lapid is foreign minister and alternate prime minister. Under the 
+government’s power-sharing agreement, he is set to become prime minister in 
+
+ August 2023. He came to politics after a career as a journalist, television presenter, 
+
+and author. He founded the Yesh Atid party in 2012, and from 2013 to 2014 he 
+served as finance minister. 
+ Kahol Lavan (Blue and White) – 8 seats (Coalition) 
+Centrist party formed in 2018 as an alternative to Likud that claimed itself more 
+committed to preserving long-standing Israeli institutions such as the judiciary, 
+articulating a vision of Israeli nationalism more inclusive of Druze and Arab citizens, 
+and having greater sensitivity to international opinion on Israeli-Palestinian issues. 
+ Leader: Benny Gantz 
+
+ 
+
+Born in 1959, Gantz is Israel’s defense minister. He served as Chief of General Staff 
+of the Israel Defense Forces from 2011 to 2015. 
+
+Congressional Research Service 
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+
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+
+ 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ ULTRA-ORTHODOX 
+
+ Shas (Sephardic Torah Guardians) – 9 seats (Opposition) 
+Mizrahi Haredi (“ultra-Orthodox”) party; favors welfare and education funds in 
+support of Haredi lifestyle; opposes compromise with Palestinians on control over 
+Jerusalem. 
+ Leader: Aryeh Deri 
+Born in 1959, Deri led Shas from 1983 to 1999 before being convicted for bribery, 
+fraud, and breach of trust in 1999 for actions taken while serving as interior minister. 
+He returned as the party’s leader in 2013. In January 2022, he resigned his Knesset 
+seat in connection with a criminal plea deal involving tax-related offenses, but 
+maintained his leadership of the party. 
+
+ 
+
+ United Torah Judaism – 7 seats (Opposition) 
+Ashkenazi Haredi coalition (Agudat Yisrael and Degel Ha’torah); favors welfare and 
+education funds in support of Haredi lifestyle; opposes territorial compromise with 
+Palestinians and conscription of Haredim; generally seeks greater application of its 
+interpretation of traditional Jewish law. 
+ Leader: Moshe Gafni 
+Born in 1952, Gafni was educated in a yeshiva (traditional Jewish school) and headed 
+
+ a kollel (institute for advanced rabbinic study). He was first elected to the Knesset in 
+
+1988. 
+
+ ARAB 
+
+ Joint List – 6 seats (Opposition) 
+Electoral slate featuring three Arab parties that combine socialist and Arab nationalist 
+political strains: Hadash (Democratic Front for Peace and Equality), Ta’al (Arab 
+Movement for Renewal), and Balad (National Democratic Assembly). 
+ Leader: Ayman Odeh 
+Born in 1975, Odeh is the leader of Hadash, an Arab Israeli socialist party, and of the 
+Joint List. An attorney, he served on the Haifa city council before becoming Hadash’s 
+
+national leader in 2006. 
+
+ 
+
+ United Arab List (UAL or Ra’am) – 4 seats (Coalition) 
+Islamist Arab party that embodies conservative social values while seeking state 
+support to improve Arabs’ socioeconomic position within Israel. 
+ Leader: Mansour Abbas 
+Born in 1974, Abbas has led the UAL since 2007 and is a qualified dentist. He led the 
+UAL into the coalition in June 2021 after receiving promises that the government 
+would focus more resources and attention on socioeconomic help for Arab Israelis. 
+
+ 
+
+ Sources: Various open sources. 
+ Note: Knesset seat numbers based on results from the March 23, 2021, election. Yamina expelled Knesset 
+member Amichai Chikli in April 2022. 
+
+Congressional Research Service 
+
+ 
+
+47 
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+ 
+ link to page 52 
+
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Appendix C. Golan Heights 
+ On March 25, 2019, President Trump signed a proclamation stating that the United States 
+recognizes the Golan Heights (hereafter, the Golan) to be part of the State of Israel.270 The 
+proclamation stated that “any possible future peace agreement in the region must account for 
+Israel’s need to protect itself from Syria and other regional threats”271—presumably including 
+threats from Iran and Lebanese Hezbollah. Israel gained control of the Golan from Syria during 
+the 1967 Arab-Israeli war, and effectively annexed it unilaterally by applying Israeli law to the 
+region in 1981 (se e Figure C-1 ). 272 
+
+ Figure C-1. Map of the Golan Heights 
+
+ 
+
+ Source: CRS, based on data from ArcGIS, U.S. State Department, ESRI, and United Nations. 
+ Notes: The DMZs could influence future border demarcation. The United States recognized the Golan Heights 
+to be part of Israel in 2019 without specifying boundaries; however, U.N. Security Council Resolution 497, 
+adopted on December 17, 1981, held that the area of the Golan Heights control ed by Israel’s military is 
+occupied territory belonging to Syria. 
+
+President Trump’s proclamation changed long-standing U.S. policy on the Golan. Since 1967, 
+successive U.S. Administrations supported the general international stance that the Golan is 
+Syrian territory occupied by Israel, with its final status subject to negotiation. In reaction to the 
+ 
+270 White House, “Proclamation on Recognizing the Golan Heights as Part of the State of Israel,” March 25, 2019. 
+271 Ibid. 
+272 The area under Israel’s control known as the Golan Heights is actually the western two-thirds of the geological 
+Golan Heights—a plateau overlooking northern Israel. The eastern third remains under Syria’s control, other than the 
+zone monitored by the U.N. Disengagement Observer Force (UNDOF). For background information on the Golan 
+Heights, see Central Intelligence Agency, Syria-Israel: The Golan Heights in Perspective , January 1982, available at 
+https://www.cia.gov/library/readingroom/docs/CIA-RDP83B00851R000400150002-5.pdf. 
+
+Congressional Research Service 
+
+ 
+
+48 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+U.S. proclamation, most other countries engaged with the issue maintained that the Golan’s status 
+had not changed.273 The Syrian government denounced the 2019 U.S. policy change as an illegal 
+violation of Syrian sovereignty and territorial integrity, and insisted that Syria was determined to 
+recover the Golan.274 
+
+From 1967 until 2011, various Israeli leaders had occasionally entered into indirect talks with 
+Syria aimed at returning some portion of the Golan as part of a lasting peace agreement. 
+However, the effect of civil war on Syria and the surrounding region, including an increase in 
+Iran’s presence, may have influenced then Prime Minister Netanyahu to shift focus from 
+negotiating with Syria on a “land for peace” basis to obtaining international support for Israel’s 
+claims of sovereignty. At certain stages of Iran’s entrenchment in conflict-ridden Syria, some 
+Iranian missiles have targeted Israeli positions in the Golan.275 
+
+Since 1974, the U.N. Disengagement Observer Force (UNDOF) has patrolled an area of the 
+Golan Heights between the regions controlled by Israel and Syria, with about 1,250 troops from 
+nine countries stationed there as of November 2021.276 During that time, Israel’s forces in the 
+Golan have not faced serious military resistance to their continued deployment, despite some 
+security threats and diplomatic challenges. Periodic resolutions by the U.N. General Assembly 
+have criticized Israel’s occupation as hindering regional peace and Israel’s settlement and de 
+facto annexation of the Golan as illegal.277 
+
+As of 2019, about 23,900 Israeli settlers and 22,000 Druze lived in the Golan.278 Most of the 
+Druze, who are concentrated in the northern part of the Golan, retain Syrian citizenship while 
+having the option to apply for Israeli citizenship.279 In December 2021, the Israeli government 
+announced a plan to double Israeli settlement in the Golan.280 
+
+ 
+273 U.N. Security Council statement, “Security Council Members Regret Decision by United States to Recognize 
+Israel’s Sovereignty over Occupied Syrian Golan,” March 27, 2019. 
+274 “Syria: Trump’s recognition of annexing the occupied Syrian Golan to Zionist entity represents highest degrees of 
+contempt for international legitimacy,” Syrian Arab News Agency, March 25, 2019. 
+
+275 CRS In Focus IF10858, Iran and Israel: Tension Over Syria , by Carla E. Humud, Kenneth Katzman, and Jim 
+Zanotti. 
+
+276 See https://undof.unmissions.org/ for general information on UNDOF, and 
+https://peacekeeping.un.org/en/mission/undof for information on troop numbers and contributing countries. 
+
+277 See, e.g., The Occupied Syrian Golan – GA Resolution (A/RES/76/81), December 9, 2021, which the United States 
+opposed. 
+
+278 Israeli settler population estimate from CIA World Factbook, “Israel”; Druze population estimate from “Druze on 
+Golan Heights reject Trump backing for Israeli sovereignty,” Reuters , March 22, 2019. 
+
+279 Eetta Prince-Gibson, “Druze in the Golan Heights have long been 'on the fence' between Syria and Israel. Syria's 
+civil war has changed things,” GlobalPost , November 16, 2017. 
+280 “Israel plans to double settlement in Golan Heights,” Associated Press , December 26, 2021. 
+
+Congressional Research Service 
+
+ 
+
+49 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ Appendix D. Examples of U.S.-Based, Israel-
+Focused Organizations 
+
+ Organization 
+
+ Website 
+
+American Israel Public Affairs Committee 
+
+https://www.aipac.org 
+
+American-Israeli Cooperative Enterprise/Jewish Virtual Library 
+
+http://www.jewishvirtuallibrary.org 
+
+American Jewish Committee 
+
+http://www.ajc.org 
+
+American Jewish Congress 
+
+http://www.ajcongress.org 
+
+Americans for Peace Now 
+
+http://www.peacenow.org 
+
+Anti-Defamation League 
+
+http://www.adl.org 
+
+Christians United for Israel 
+
+https://cufi.org 
+
+Conference of Presidents of Major Jewish Organizations 
+
+http://www.conferenceofpresidents.org 
+
+Endowment for Middle East Truth 
+
+https://emetonline.org 
+
+Foundation for Middle East Peace 
+
+http://www.fmep.org 
+
+Hadassah (The Women’s Zionist Organization of America, Inc.) 
+
+http://www.hadassah.org 
+
+Israel Bonds 
+
+http://www.israelbonds.com 
+
+Israel Institute 
+
+http://www.israelinstitute.org 
+
+Israel Policy Forum 
+
+http://www.israelpolicyforum.org 
+
+J Street 
+
+http://jstreet.org 
+
+Jewish Federations of North America 
+
+http://www.jewishfederations.org 
+
+Jewish Institute for National Security of America 
+
+https://jinsa.org 
+
+Jewish National Fund 
+
+http://www.jnf.org 
+
+Jewish Policy Center 
+
+http://www.jewishpolicycenter.org 
+
+MirYam Institute 
+
+https://www.miryaminstitute.org 
+
+New Israel Fund 
+
+http://www.nif.org 
+
+S. Daniel Abraham Center for Middle East Peace 
+
+http://www.centerpeace.org 
+
+U.S. Israel Education Association 
+
+https://www.usieducation.org 
+
+Zionist Organization of America 
+
+http://www.zoa.org 
+
+ 
+
+ 
+
+ Author Information 
+
+ 
+Jim Zanotti 
+
+ 
+
+Specialist in Middle Eastern Affairs 
+ 
+
+Congressional Research Service 
+
+ 
+
+50 
+
+ 
+ Israel: Background and U.S. Relations 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan 
+shared staff to congressional committees and Members of Congress. It operates solely at the behest of and 
+under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other 
+than public understanding of information that has been provided by CRS to Members of Congress in 
+connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not 
+subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in 
+its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or 
+material from a third party, you may need to obtain the permission of the copyright holder if you wish to 
+copy or otherwise use copyrighted material. 
+
+ 
+
+Congressional Research Service 
+
+RL33476 · VERSION 93 · UPDATED 
+
+51
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+Order Code RL34702
+
+ Potential Trade Effects of Adding Vietnam to the 
+
+ Generalized System of Preferences Program 
+
+ Updated October 9, 2008 
+
+Michael F. Martin and Vivian C. Jones
+
+Analyst in Asian Trade and Finance,
+
+ and Specialist in International Trade and Finance
+
+Foreign Affairs, Defense, and Trade
+
+ 
+ Potential Trade Effects of Adding Vietnam to the
+
+Generalized System of Preferences Program
+
+ Summary
+ 
+
+In May 2008, Vietnam formally requested to be added to the U.S. Generalized
+
+System of Preferences (GSP) program as a “developing country.” On June 20, 2008,
+the office of the U.S. Trade Representative (USTR) announced that it was initiating
+a formal review of Vietnam’s eligibility for GSP benefits and would accept public
+comments on the application until August 4, 2008. Vietnam has already been
+accepted into several other developed-country GSP programs around the world,
+including Canada, the European Union (EU), and Japan.
+
+The GSP statute provides the President with the authority to designate any
+
+country a beneficiary developing country, provided the country complies with various
+trade policy and labor conditions. Congress does not need to act to approve GSP
+status for Vietnam. The President is, however, required to notify Congress of his
+intention. The inclusion of Vietnam into the GSP program is generally viewed as
+another step in the development of closer bilateral relations.
+
+Most of the public comments submitted to the USTR were supportive of
+
+approving Vietnam’s application. However, there were some issues raised that could
+cause problems in accepting Vietnam into the GSP program — in particular,
+Vietnam’s record on workers’ rights. In addition, Vietnam’s record on human rights
+may also have an impact on its application, even though the President is not legally
+required to consider this issue when evaluating Vietnam’s application.
+
+If accepted into the GSP program, up to 3,400 different types of exports from
+
+Vietnam could potentially enter into the United States duty-free. While Vietnam’s
+leading exports to the United States — knitted and non-knitted clothing — are
+deemed “import sensitive” and therefore excluded from GSP eligibility, some of its
+fastest growing exports are eligible for duty-free status under the GSP. These exports
+include electrical machinery, fruits, and coffee preparations. Imports of these
+commodities would likely increase if Vietnam is granted beneficiary developing
+country (BDC) status. This could lead to an increase in the U.S. bilateral trade deficit
+with Vietnam and a shift in the mix of U.S. imports from Vietnam. It might also
+foster a relocation of some assembly operations from China to Vietnam, thereby
+reducing the U.S. bilateral trade deficit with China. 
+
+A one-year extension of the Generalized System of Preferences program was
+
+included in H.R. 7222, which was passed in the House (September 29, 2008 and
+October 3, 2008) and Senate (October 2, 2008), and is awaiting the President’s
+signature.
+
+This report will be updated as circumstances require. 
+
+ 
+ Contents 
+
+What Is GSP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Country Eligibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+Product Eligibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Process for Vietnam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+Evaluating Vietnam’s Prospects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+Compliance with Eligibility Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+
+Is Vietnam a “Communist Country? . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+Workers’ Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+
+Action in Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+Public Comments on GSP Status for Vietnam . . . . . . . . . . . . . . . . . . . . . . . 8
+Human Rights in Vietnam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+
+Potential Impact on U.S. Trade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
+
+Issues for Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
+
+ List of Figures 
+
+Figure 1. U.S. Merchandise Trade with Vietnam, 2000-2007 . . . . . . . . . . . . . . 12
+
+ List of Tables 
+
+Table 1. Top Five U.S. Imports from Vietnam, 2007 . . . . . . . . . . . . . . . . . . . . . 12
+
+ 
+ Potential Trade Effects of Adding Vietnam to
+
+the Generalized System of Preferences
+
+Program
+
+In May 2008, the Socialist Republic of Vietnam (Vietnam) formally requested
+
+consideration for designation as a “beneficiary developing country” (BDC) under the
+United States’ Generalized System of Preferences (GSP) program. If accepted into
+the GSP program, up to 3,400 different types of exports from Vietnam could
+potentially enter into the United States duty-free. While Vietnam’s top export to the
+United States — clothing — is not GSP-eligible, other leading exports, such as
+electrical machinery, fruits, and coffee preparations, could benefit from Vietnam’s
+addition to the GSP program. Vietnam has already been accepted into several other
+developed-country GSP programs around the world, including Canada, the European
+Union (EU), and Japan.
+
+On June 20, 2008, the U.S. Trade Representative (USTR) announced that it was
+
+initiating a review of Vietnam’s eligibility for GSP benefits, and solicited comments
+on the matter until August 4, 2008.1 Five days later, Vietnam’s Prime Minister
+Nguyen Tan Dung raised the issue of Vietnam’s GSP application with President
+Bush during his official visit to the White House. In a joint statement issued after
+their meeting, “President Bush affirmed that the United States is seriously reviewing
+Vietnam’s request to be designated as a beneficiary of the Generalized System of
+Preferences program.”2 At the time this report was written, the President had not
+announced his decision on Vietnam’s GSP application.
+
+Vietnam’s addition to the U.S. GSP program is generally viewed as another step
+
+in the process of promoting the continued growth of trade relations and expanding
+bilateral ties between the two countries. In December 2006, Congress passed and
+President Bush signed H.R. 6111 (P.L.109-432), extending permanent normal trade
+relations (PNTR) status to Vietnam. On January 11, 2007, Vietnam acceded into
+membership in the World Trade Organization (WTO). On June 21, 2007, the two
+nations concluded a Trade and Investment Framework Agreement (TIFA).3 During
+their summit meeting (the fourth such meeting in four years), Prime Minister Dung
+and President Bush also discussed initiating negotiations of a Bilateral Investment
+Treaty (BIT). Vietnam has also expressed an interest in eventually negotiating a Free
+Trade Agreement (FTA) with the United States.
+
+1 73 F.R. 35173, June 20, 2008.
+
+2 White House, Office of the President, “Joint Statement Between the United States of
+America and the Socialist Republic of Vietnam,” Press Release, June 25, 2008.
+
+3 The text of the U.S.-Vietnam TIFA is available on the USTR’s web page at
+[http://www.ustr.gov/assets/Trade_Agreements/TIFA/asset_upload_file81_12935.pdf].
+
+ 
+ CRS-2
+
+ What Is GSP? 
+
+The Generalized System of Preferences (GSP) provides non-reciprocal
+
+preferential tariff treatment to certain products imported from designated developing
+countries. The United States, the European Union, and other developed countries
+implemented such programs in the 1970s in order to promote economic growth in
+developing countries by stimulating their exports. The U.S. program was established
+by Title V of the Trade Act of 1974 (P.L. 93-618) for a 10-year period. Since then,
+Congress has extended the program nine times, most recently through December 31,
+2008, in section 8002 of P.L. 109-432.4 The House and Senate recently passed a one-
+year extension of GSP in section 4 of H.R. 7222, and the measure is awaiting the
+President’s signature.
+
+The basic principle behind the GSP is to provide certain goods originating in
+
+developing countries with preferential market access (usually in the form of lower
+tariff rates or duty-free status) to developed country markets in order to spur
+economic growth. The program was first adopted internationally in 1968 by the
+United Nations Conference on Trade and Development (UNCTAD) at the UNCTAD
+II Conference.
+
+In general, the U.S. GSP program authorizes the President to grant duty-free
+
+treatment under the GSP for any eligible product from any beneficiary developing
+country (BDC) or least-developed beneficiary developing country (LDBDC). The
+statute provides the President with specific political and economic criteria to use
+when designating eligible countries and products.5
+
+ Country Eligibility 
+
+Under the GSP eligibility criteria, there are certain mandatory factors that may
+
+not be waived. First, certain developed countries are specifically excluded.6 Other
+mandatory criteria require exclusion of any country that:
+
+! is “Communist,” unless it has normal trade relation status with the
+
+United States; is a member in the World Trade Organization (WTO)
+and the International Monetary Fund (IMF); and it is “not dominated
+or controlled by international communism”;
+
+! engages in actions that would restrict or raise prices of vital
+
+commodities;
+
+4 19 U.S.C. §§ 2461-2467, as amended.
+
+5 19 U.S.C. § 2462; section 502 of P.L. 93-618, as amended. For a more detailed discussion
+of the GSP program, see CRS Report RL33663, Generalized System of Preferences:
+Background and Renewal Debate, by Vivian C. Jones.
+
+6 These countries are Australia, Canada, European Union member states, Iceland, Japan,
+Monaco, New Zealand, Norway, and Switzerland.
+
+ 
+ CRS-3
+
+! provides trade preferences to developed countries other than the
+
+United States which has, or is likely to have, a significant adverse
+effect on United States commerce.
+
+Other mandatory criteria may be waived “if the President determines that such
+
+designation will be in the national economic interest of the United States and reports
+such determination to the Congress with the reasons therefor.” These criteria
+preclude countries that: 
+
+! have nationalized or expropriated the property of U.S. citizens or
+
+companies;
+
+! have failed to acknowledge or enforce arbitral awards that are in
+
+U.S. favor;
+
+! aided or abetted individuals or groups that have engaged in
+
+international terrorism;
+
+! have not taken steps to provide its workers with internationally
+
+recognized worker rights; or
+
+! have not taken steps to “eliminate the worst forms of child labor.”7
+
+Other discretionary factors that the President may consider when deciding to
+
+confer BDC status are: (1) the desire of the country to be designated; (2) the level of
+economic development of the country, including gross national product (GNP) and
+living standards; (3) whether other developed countries offer similar tariff benefits
+to the country; (4) the degree to which the country has agreed to provide equitable
+and reasonable access to its markets, commodities, and resources; (5) the level of
+protection it provides to intellectual property; (6) the extent to which it has reduced
+barriers to trade and investment; and (7) the degree to which it has provided its
+workers with workers rights including collective bargaining, a minimum age for child
+labor, and prohibition of forced labor or the worst forms of child labor.8
+
+ Product Eligibility 
+
+The President is authorized to designate products as eligible for GSP treatment
+
+after consultation with the International Trade Commission.9 Products are designated
+generally for all GSP recipients to the extent that countries have not exceeded
+statutory limits for importing certain products. Product eligibility under GSP is also
+restricted in the law by several factors. First, the GSP statute specifically excludes
+certain categories of goods as “import-sensitive,” including textiles and apparel;
+certain watches; footwear and other accessories; certain electronics, steel, and glass
+products; and certain agricultural products subject to tariff-rate quotas.10 
+
+Second, the law establishes automatic “competitive need limits” (CNLs) that
+
+require the President to suspend GSP treatment if imports of a product from a single
+
+7 19 U.S.C. § 2462, as amended.
+
+8 Ibid.
+
+9 19 U.S.C. § 2463(a)(1).
+
+10 19 U.S.C. § 2463(b).
+
+ 
+ CRS-4
+
+country reach a specified threshold value ($135 million in 2008) or if 50% or more
+of total U.S. imports of a product entering under GSP come from a single country
+(unless a waiver is granted).11 Third, GSP rules of origin only allow duty-free entry
+if the article is imported directly from the beneficiary country, and at least 35% of the
+value (of materials and/or processing) of an eligible product is the “growth, product,
+or manufacture” of a beneficiary developing country.12
+
+ Process for Vietnam 
+
+An evaluation of Vietnam’s eligibility for GSP status began with a Federal
+
+Register notice announcing the review.13 Public comments were solicited from June
+20, 2008 to August 4, 2008.14 A subsequent review to determine whether Vietnam
+complies with the statutory requirements for designation as a GSP beneficiary will
+be administered by the GSP Subcommittee of the Trade Policy Staff Committee
+(TPSC), an interagency group chaired by the USTR.15 The USTR may also, as
+necessary, request that the International Trade Commission evaluate the potential
+trade effects of Vietnam’s GSP request.16 At the conclusion of the review, the TPSC
+will present its findings to the USTR, who will, in turn, present a recommendation
+to the President. The final decision to grant Vietnam GSP eligibility or not will be
+made by the President.
+
+ Evaluating Vietnam’s Prospects 
+
+Vietnam’s acceptance into the U.S. GSP program will hinge on a combination
+
+of the TPSC’s evaluation (and the President’s subsequent approval) of Vietnam’s
+compliance with these eligibility criteria, and the perceived acceptability of including
+Vietnam as a beneficiary developing country.
+
+ Compliance with Eligibility Criteria 
+
+There may be some ambiguity regarding Vietnam’s compliance with both the
+
+mandatory and discretionary GSP criteria. For the four mandatory criteria, the most
+debatable issue may be its classification as a “Communist country,” and more
+
+11 19 U.S.C. § 2463(c).
+
+12 19 U.S.C. § 2463(a)(2).
+
+13 73 F.R. 35173, June 20, 2008.
+
+14 Public comments concerning Vietnam’s GSP eligibility are posted on the USTR website:
+[http://www.ustr.gov/assets/Trade_Development/Preference_Programs/GSP/GSP_Revie
+w_to_Consider_Designation_of_Socialist_Republic_of_Vietnam_as_a_Beneficiary_Dev
+eloping_Country_Under_the_GSP/asset_upload_file576_15064.pdf].
+
+15 The TPSC was established by Section 242 of the Trade Expansion Act of 1962 (19 U.S.C.
+§ 1872) and implemented by Executive Order 12188, as amended. The President delegated
+the administration of the GSP program to the committee in sec. 8 of Executive Order 11846,
+as amended.
+
+16 19 C.F.R. § 2007.2(e).
+
+ 
+ CRS-5
+
+specifically whether or not it is controlled or dominated by “international
+communism.” For the waivable criteria, the most likely source of challenges is
+Vietnam’s record in providing workers with internationally recognized workers’
+rights.
+
+ Is Vietnam a “Communist Country?” U.S. federal law does not currently
+
+include a specific definition of what constitutes a “Communist country.” The concept
+of Communism has two distinct common definitions — one political and one
+economic. The political definition typically hinges on the domination of society’s
+political system by a single and self-perpetuating party. The economic definition is
+usually based on the holding of all property in common, with the ownership being
+ascribed to the community as a whole or to the state.
+
+Politically, the Vietnamese government does not refer to itself as communist
+
+country, but as socialist republic. However, Vietnam is a one-party state controlled
+by the Communist Party of Vietnam (VCP). Since the mid-1990s, the VCP appears
+to have followed a strategy of permitting most forms of personal and religious
+expression while selectively repressing individuals and organizations that it deems
+a threat to the party’s monopoly on power.
+
+Economically, Vietnam has been steadily transforming its centrally planned
+
+economy into a market economy, and has allowed the creation and growth of private
+enterprise. Vietnam’s constitution and civil code recognize and protect private
+property rights. Yet, government influence and control over Vietnam’s economy still
+remains comparatively high.17
+
+Even if Vietnam were determined to be a “Communist country,” GSP statutory
+
+provisions specify that it can still qualify for GSP status if it is a member of the WTO
+and IMF, received NTR status from the United States, and is found to be “not
+dominated or controlled by international communism.” Vietnam is a recent member
+of the WTO (date of accession January 11, 2007) and a member of long-standing in
+the IMF (since September 1956). In December 2006, Vietnam was conferred
+permanent NTR status by the United States. In addition, given that the Soviet Union
+and its Council for Mutual Economic Assistance (Comecon) no longer exist, it is
+unclear how to define what constitutes “domination or control by international
+communism.”
+
+ Workers’ Rights. Among the five mandatory, but waivable, criteria,
+
+Vietnam’s recognition of internationally-accepted workers’ rights may prove to be
+the most controversial. Prior to the 1986 advent of doi moi , Vietnam’s process of
+market-oriented economic renovation, there were many allegations about substandard
+working conditions in Vietnam, including “sweatshop” working conditions, the use
+of child labor, and severe restrictions on the right of association and collective
+
+17 For more information, see CRS Report RL33316, U.S.-Vietnam Relations: Background
+and Issues for Congress , by Mark Manyin. 
+
+ 
+ CRS-6
+
+bargaining.18 Since then, the Vietnamese government is generally perceived to have
+made concerted efforts to comply with internationally-recognized labor standards. 
+
+In its statement of support for GSP designation, the Vietnamese government
+
+focused on its partnership with the International Labor Organization (ILO) and its
+ratification of several of the ILO’s conventions as demonstrating its commitment to
+comply with international labor rights standards. Vietnam rejoined the ILO as a
+member state in 1992 and has worked with the ILO in drafting new labor laws,
+including the 1994 Labor Code. In addition, Vietnam has ratified five of the eight
+fundamental ILO conventions — covering compulsory labor, income inequality,
+discrimination, minimum age, and the worst forms of child labor — and an additional
+12 other ILO conventions. Vietnam reported it is considering ratification of two more
+conventions, concerning the freedom of association and the right to collective
+bargaining. In addition, the United States and Vietnam signed a Memorandum of
+Understanding regarding labor cooperation in November 2000, which has fostered
+the exchange in technical expertise and training on a broad range of labor issues.
+
+ Freedom of Association. Despite the aforementioned efforts by the
+
+Vietnamese government, critics still maintain that working conditions remain below
+international standards. In particular, Vietnam has been criticized for its failure to
+allow independent labor unions and respect the right of association. At present, all
+labor unions in Vietnam must be a member of the Vietnam General Confederation
+of Labor (VGCL). Efforts to organize independent unions in Vietnam reportedly
+have been thwarted by government suppression, including the arrest and
+imprisonment of union leaders. In Vietnam’s GSP submission, the government
+maintains that “the Vietnam Constitution of 1992, along with other domestic laws,
+guarantees that workers have the right of association” and that “citizens are entitled
+to freedom of speech and freedom of the press; they have the right to receive
+information and the right of assembly, association and demonstration in accordance
+with the law.”19
+
+Despite the provisions in Vietnam’s constitution, some observers maintain that
+
+the ability of workers to form independent unions has, to some extent, been thwarted.
+According to Amnesty International, two days after Tran Quoc Hien was chosen as
+spokesperson for the United Workers-Farmers Organization (UWFO) in January
+2007, he was arrested. The Vietnamese authorities claimed that he and his
+accomplices incited demonstrations and posted “distorted” articles on the Internet.
+On May 15, 2007, Tran Quoc Hien was sentenced to five years’ imprisonment plus
+
+18 For more information about pre-Doi Moi working conditions in Vietnam, see CRS Report
+RL30896, Vietnam’s Labor Rights Regime: An Assessment , by Mark Manyin, Thomas Lum,
+Lois McHugh, Phuong-Khanh Nguyen, and Wendy Zeldin.
+
+19 Government of the Socialist Republic of Vietnam. “Statement re Supporting
+Documentation [of GSP Status],” May 9, 2008, p. 9. 
+
+ 
+ CRS-7
+
+two years’ probation.20 Human Rights Watch also reports that some leaders of
+independent unions have been arrested, harassed and intimidated.21
+
+Other observers conclude that since the launch of the doi moi reforms, worker
+
+rights have made progress despite the restrictions on the right to organize. In
+addition, hundreds of unaffiliated (and therefore unofficial) “labor associations” have
+sprouted without significant repression, and in many recent cases, Vietnamese
+workers went on strike reportedly because they felt that they were not well-
+represented by the official union.
+
+Workers in Vietnam have the legal right to collective bargaining; the VGCL is
+
+supposed to organize a union within six months of the establishment of any new
+business, regardless of its ownership — state, foreign, or private. According to the
+State Department’s 2007 Country Report on Human Rights Practices , “In actuality
+only 85 percent of state-owned enterprises, 60 percent of foreign-invested enterprises,
+and 30 percent of private enterprises were unionized.”
+
+ Right to Strike. According to the government of Vietnam, strikes are not
+
+uncommon in Vietnam, and the Labor Code was amended in late 2006 in order to
+clarify the cases in which a strike may occur (i.e., after a legally mandated dispute
+resolution process has been carried out).22 Vietnamese officials also maintain that
+there are many strikes in Vietnam, and that even in cases where strikes are deemed
+“illegal,” the law prohibits retribution against strikers.23
+
+There reportedly were nearly 400 strikes in Vietnam in the first eight months of
+
+2008, mostly spontaneous industrial actions taken without trade union leadership.24
+In most cases, the workers have struck for higher wages and better working
+conditions. Many of the strikes have occurred at foreign-owned enterprises,
+particularly at South Korean and Taiwanese manufacturing facilities.25 The
+Vietnamese government — led by the Ministry of Labor, War Invalids and Social
+Affairs (MoLISA) — for the most part has not moved against the strikes, despite the
+fact that many have been technically illegal.
+
+20 “Vietnam: Internet Writer Tran Quoc Hien Sentenced,” English Pen , May 25, 2007.
+
+21 Testimony by Sophie Richardson, Asia Advocacy Director, Human Rights Watch, before
+the House Committee on Foreign Affairs Subcommittee on International Organizations,
+Human Rights, and Oversight, November 6, 2007.
+
+22 Government of the Socialist Republic of Vietnam. “Statement re Supporting
+Documentation [of GSP Status],” May 9, 2008, p. 10.
+
+23 Ibid.
+
+24 “Solutions to Labourers’ Strikes Require Efforts from All Sides,” Vietnam Net , September
+5, 2008. 
+
+25 Author’s interview with unnamed industrial sources.
+
+ 
+ CRS-8
+
+ Action in Congress 
+
+Many in Congress continue to be concerned about Vietnam’s human rights
+
+record. On October 1, 2008, Senator Barbara Boxer introduced S. 3678, the Vietnam
+Human Rights Act of 2008. Among other things, this bill seeks to prohibit the
+President from granting GSP benefits to Vietnam unless the President determines and
+certifies to Congress that the Government of Vietnam (1) fully protects the right of
+freedom of association in both law and practice; and (2) does not practice or condone
+serious violations of workers’ rights, including detention, harassment, or arrest of
+labor activists or of individuals who write, speak, or otherwise disseminate
+information on labor rights.
+
+Others in Congress see the granting of GSP status to Vietnam as an important
+
+foreign policy tool, much like the U.S. grant of PNTR status to Vietnam and U.S.
+support of its WTO accession. First, some see the value in continuing to expand
+relations with a country that continues to have an ambivalent relationship with
+China.26 Second, many also believe that continued engagement with Vietnam in the
+commercial policy arena can serve as an indirect encouragement for the government
+to promote increased pluralism, accountability, and adherence to the “rule of law.”27
+Some believe that continued normalization of relations with Vietnam is also
+symbolically important because it places greater distance between the U.S.-Vietnam
+relationship and the legacy of the Vietnam war.28
+
+ Public Comments on GSP Status for Vietnam 
+
+As part of the process of assessing Vietnam’s suitability for the GSP program,
+
+the USTR accepted public comments until August 4, 2008. Over 20 different
+organizations and companies submitted comments. Eighteen of the commentators
+supported Vietnam’s acceptance in the GSP program; two opposed it; and three
+expressed some reservations, but stopped short of stating their opposition. 
+
+Supporters of adding Vietnam as a BDC in the GSP program generally pointed
+
+to several factors. They maintained that it would be beneficial to both Vietnam and
+the United States economically and politically. In addition, it would help raise many
+of the people of Vietnam out of poverty — one of the principal goals of the GSP
+program. The supporters also pointed to Vietnam’s doi moi policies as evidence of
+its compliance with the GSP eligibility and then indicated that acceptance into the
+GSP program would help progress Vietnam’s transformation into a market economy.
+Some indicated that by including Vietnam in the GSP program, U.S. companies
+would have a feasible alternative to locating manufacturing facilities in China, which
+would improve their competitiveness in the global market and potentially reduce the
+U.S. trade deficit with China. Others cautioned that the exclusion of Vietnam from
+
+26 CRS Report RL33490, Vietnam PNTR Status and WTO Accession: Issues and
+Implications for the United States, by Mark E. Manyin and William H. Cooper (Archived).
+
+27 Ibid.
+
+28 Ibid.
+
+ 
+ CRS-9
+
+the GSP program might hinder the ability of U.S. companies to compete for
+investment opportunities in Vietnam.
+
+Three commentators — the American Federation of Labor and Congress of
+
+Industrial Organizations (AFL-CIO), the International Intellectual Property Alliance
+(IIPA), and the Pharmaceutical Research and Manufacturers of America (PhRMA)
+ — pointed out problems or issues with Vietnam’s compliance with the GSP
+eligibility criteria, but did not directly state their opposition to adding Vietnam to the
+program. The AFL-CIO’s criticisms focused on its assessment that “much more
+needs to be done to bring its [Vietnam’s] labor laws and practices in line with
+internationally recognized worker rights.”29 In particular, the AFL-CIO cited
+continuing problems with Vietnamese workers’ freedom of association, their right
+to organize and bargain collectively, restrictions on the ability to strike, and problems
+in working conditions (minimum wage enforcement, excessive working hours, and
+unsafe working conditions).
+
+The IIPA’s comments centered on Vietnam’s compliance with the intellectual
+
+property rights (IPR) standards and market access requirements for GSP eligibility.30
+On IPR protection, the IIPA maintained that 90% of business software and 95% of
+records and music in Vietnam are pirate copies. In addition, the IIPA stated that
+Vietnam continues to restrict foreign access to its motion picture, home video,
+broadcast, and music/sound recording markets. Despite their apparent misgivings
+about Vietnam’s GSP application, the IIPA suggests that it be granted one year of
+eligibility, with renewal subject to a review of Vietnam’s progress on IPR protection.
+
+The submission by PhRMA also focused on the issue of IPR protection in
+
+Vietnam, but with an emphasis on its application to pharmaceuticals.31 Specific
+topics raised by PhRMA in its comments included IPR enforcement, data exclusivity,
+trademark infringement, counterfeiting, and “trade dress” violations.32 PhRMA also
+expressed concern about market access and pricing restrictions in Vietnam’s
+pharmaceuticals market.
+
+There were two submissions to USTR — one by the U.S. Committee to Protect
+
+Vietnamese Workers (CPVW) and another by the U.S. producers of polyethylene
+carrier bags — that opposed GSP for Vietnam. The U.S. Committee to Protect
+Vietnamese Workers was established by a group of overseas Vietnamese “to protect
+
+29 Comments by AFL-CIO and other organizations on Vietnam’s GSP Application,
+submitted to USTR on August 4, 2008; available online at [http://www.ustr.gov/assets/
+Trade_Development/Preference_Programs/GSP/GSP_Review_to_Consider_Designation
+_of_Socialist_Republic_of_Vietnam_as_a_Beneficiary_Developing_Country_Under_the
+_GSP/asset_upload_file576_15064.pdf].
+
+30 Ibid.
+
+31 Ibid.
+
+32 “Trade dress” refers to the physical appearance — color, shape, textile, graphics, and/or
+size — of a product.
+
+ 
+ CRS-10
+
+the rights and interests of all Vietnamese workers.”33 In their comments to USTR,
+the CPVW indicated that it supported acceptance of Vietnam into the GSP program
+“in principle,” but opposed the acceptance in practice because “Vietnam has not met
+even the basic GSP criteria on labor.” The CPVW maintained that Vietnam failed
+to meet the eligibility criteria for the right of association, the right of assembly, the
+right to organize and bargain collectively, the prohibition of forced or compulsory
+labor, minimum age requirements and child labor, working conditions, and
+compensation requirements. The CPVW concluded their comments with a list of
+seven specific conditions to be met before granting GSP eligibility to Vietnam.
+
+The comments in opposition by the U.S. producers of polyethylene carrier bags
+
+focused on the reputed damage to their industry from the recent rapid increase in
+plastic bag imports from China, Malaysia, and Thailand. According to their
+submission, antidumping duties on plastic bag imports from those three countries
+have slowed import growth, but have also led to a relocation of operations to
+Vietnam. Based on their reported experience, the U.S. producers requested that
+“Vietnam be precluded from seeking GSP treatment” for polyethylene carrier bags.
+
+ Human Rights in Vietnam 
+
+Legally, the human rights conditions of a country do not have to be considered
+
+by the President when making a decision on its application for GSP eligibility.
+However, the issue of human rights in Vietnam has been an important factor in every
+previous case when the United States has considered strengthening bilateral trade
+relations.
+
+It is difficult to make country-wide generalizations about the state of human
+
+rights in Vietnam. On the one hand, the VCP has permitted the growth of an
+independent press, so long as its criticism of the government is limited to issues such
+as corruption, economic policy, nature conservation and environmental pollution.
+Similarly, the Vietnamese government has generally allowed the freedom of worship,
+regardless of faith, so long as the religious organization registers with the authorities.
+As of 2006, Vietnam was no longer listed as a “country of particular concern” (CPC)
+in the State Department’s International Religious Freedom Report .
+
+On the other hand, the VCP regularly represses groups and individuals it
+
+perceives as a potential threat to its political power. Human Rights Watch claims that
+the Vietnamese government cracked down on democracy advocates during U.S.
+Deputy Secretary of State John Negroponte’s September 2008 trip to Vietnam,
+detaining and interrogating “at least a dozen” activists.34 Earlier in September, the
+Vietnamese government broke up a protest in Hanoi organized by Catholics who
+claim that a previously state-owned company (since privatized) had unlawfully been
+
+33 Quote from the organization’s home page — [http://www.protectvietworkers.com/].
+
+34 “Vietnam: New Round of Arrests Target Democracy Activists,” Human Rights Watch ,
+September 12, 2008.
+
+ 
+ CRS-11
+
+given land belonging to a Catholic church.35 In July 2008, there were reported
+tensions between the Vietnamese government and the banned Unified Buddhist
+Church of Vietnam in making the funeral arrangements for their late patriarch, Thich
+Huyen Quang.36
+
+ Potential Impact on U.S. Trade 
+
+Projecting the impact of Vietnam becoming a BDC under the U.S. GSP program
+
+on its bilateral trade with the United States is difficult for a variety of technical
+reasons.37 Scholarly studies of both the U.S. and EU GSP programs on developing
+countries’ exports have come to differing conclusions. However, the rapid rise in
+bilateral trade following the U.S. extension of NTR to Vietnam may indicate that
+Vietnam’s exports to the United States will increase if it becomes a BDC. The impact
+on U.S. exports to Vietnam is less certain.
+
+Scholarly studies have also come to conflicting conclusions of the impact of the
+
+GSP program on international trade flows. Depending on the methodology used and
+the assumptions made, the studies have estimated the trade effect for GSP-eligible
+products as ranging from being negligible to increasing by over 60%.38 For example,
+a 2006 study of EU trade preference programs estimated that the EU GSP program
+“does not significantly increase exports” for beneficiary countries.39 Most of the
+studies calculated a less than 20% increase in GSP-eligible product exports.
+
+Although studies may differ on the trade effects of GSP programs, recent
+
+bilateral trade figures provide some evidence that the liberalization of U.S. trade
+relations with Vietnam does foster greater trade flows, particularly an increase in
+U.S. imports. Following the December 10, 2001 grant of NTR status to Vietnam,
+official U.S. trade statistics indicate that U.S. total merchandise trade with Vietnam
+doubled from $1.5 billion in 2001 to $3.0 billion in 2002 (See Figure 1 ). During that
+same time period, U.S. imports from Vietnam rose from $1.1 billion to $2.4 billion.
+By comparison, the increase in U.S. imports between 2000 and 2001 was just over
+$230 million. U.S. exports to Vietnam, by contrast, rose only slightly — increasing
+by less than $120 million — a comparable amount to the increase between 2000 and
+2001. While acceptance into the U.S. GSP program is not as dramatic shift in trade
+status as NTR, the growth in post-NTR trade flows indicate that granting Vietnam
+
+35 Nga Pham, “Prayers and Protests in Vietnam,” BBC News, September 2, 2008.
+
+36 “Funeral Services Held for Dissident Patriarch of Banned Vietnamese Buddhist Church,”
+ Associated Press , July 11, 2008.
+
+37 For an explanation of the technical problems of conducting such a projection, see Craig
+R. MacPhee and Victor Iwuagwu Oguledo, “The Trade Effects of the U.S. Generalized
+System of Preference,” Atlantic Economic Journal , December 1991, Vol. 19, No. 4, pp. 19-
+26.
+
+38 MacPhee and Oguledo, op. cit. 
+
+39 Maria Persson and Fredrik Wilhelmsson, “Assessing the Effects of EU Trade Preferences
+for Developing Countries,” Working Papers, Lund University, Department of Economics,
+2006:4. 
+
+ 
+ CRS-12
+
+BDC status under the Generalized System of Preferences should increase its exports
+to the United States.
+
+ Figure 1. U.S. Merchandise Trade with Vietnam, 2000-2007 
+
+ (U.S. $ Billions) 
+
+12
+
+10
+
+8
+
+6
+
+4
+
+2
+
+0
+
+2000 2001 2002 2003 2004 2005 2006 2007
+
+Exports
+
+Imports
+
+ Source: U.S. International Trade Commission.
+
+Determining which Vietnamese exports will increase if the United States
+
+approves Vietnam’s GSP application is also difficult. It would logical to assume that
+most of Vietnam’s export growth will occur among the GSP-eligible products. An
+examination of recent trade data, however, reveals that many of Vietnam’s top
+exports are not GSP-eligible.
+
+According to U.S. trade statistics, over 40% of U.S. imports from Vietnam in
+
+2007 were articles of apparel (see Table 1 ). The next two top U.S. imports from
+Vietnam — furniture and footwear — together contributed another 20%. The fifth
+largest import from Vietnam in 2007 was crude oil. Taken together, the top five
+product categories accounted for over two-thirds of U.S. imports from Vietnam in
+2007.
+
+ Table 1. Top Five U.S. Imports from Vietnam, 2007 
+
+ Percentage 
+
+ Category 
+
+ Value 
+
+ of Total 
+
+Knitted or Crocheted Clothing (61)
+
+$2,154,742,771
+
+20.3%
+
+Non-knitted or Crocheted Clothing (62)
+
+$2,137,930,586
+
+20.1%
+
+Furniture (94)
+
+$1,229,393,282
+
+11.6%
+
+ 
+ CRS-13
+
+Footwear (64)
+
+$1,041,404,330
+
+9.8%
+
+Petroleum and Mineral Fuels (27)
+
+$776,072,516
+
+7.3%
+
+Total Imports
+
+$10,632,958,719
+
+ Source: U.S. International Trade Commission. Numbers in parentheses refer to HTS chapter.
+
+Vietnam’s current top exports to the United States are unlikely to benefit from
+
+Vietnam’s acceptance into the U.S. GSP program. Very few articles of apparel are
+GSP-eligible. Similarly, only a select group of furniture items are GSP-eligible —
+mostly light fixtures and mattresses. Footwear is also an import category that is
+largely excluded from the GSP program, as is crude oil. Therefore, Vietnam’s top
+five exports to the United States are not likely to benefit from duty-free access under
+GSP.
+
+Some of Vietnam’s fastest growing exports to the United States, however, may
+
+benefit from duty-free access under GSP. Among Vietnam’s top exports — product
+categories that provided more than 0.5% of U.S. imports from Vietnam — the growth
+leaders between 2000 and 2007 were: soaps (HTS40 chapter 34), plastics and articles
+of plastic (39), paper and paper products (48), headgear (65), machinery (84), and
+electrical machinery (85). A comparison of these six product categories to the 2007
+list of GSP-eligible items reveals that three of these product categories — soaps,
+plastics and articles of plastic, machinery, and electrical machinery — are generally
+GSP-eligible, implying a greater likelihood of growth. Paper and paper products, as
+well as headgear, are not typically eligible for GSP benefits, so there is little chance
+of trade gains in these product categories.
+
+The possibility of GSP eligibility may have the greatest implication for
+
+Vietnam’s machinery and electrical machinery industries, since the Vietnamese
+government has been actively promoting its nation to overseas investors as a good
+location for machinery and electrical machinery operations. In addition, rising
+production costs in other parts of Asia — especially in China — are leading
+manufacturers to explore alternative locations for their Asian operations. Chinese
+companies, in particular, facing rising labor costs and the strengthening of the
+renminbi (RMB) against the U.S. dollar, may find the added bonus of GSP eligibility
+an incentive to relocate their final assembly operations to Vietnam. Such a shift
+could partially offset the general rise in the U.S. bilateral trade deficit with China, but
+would also increase the U.S. bilateral trade deficit with Vietnam. However, all of
+these trade effects would be limited in size by the competitive need limits (CNLs).
+
+Vietnam’s designation as a BDC under the GSP is likely to have little effect on
+
+U.S. producers of import-competing products, because domestic producers are
+largely shielded from severe economic impact under the preference due to the CNLs
+and other restrictions. Furthermore, if U.S. manufacturers of a product are adversely
+impacted by imports under GSP, they may petition that the product be removed from
+GSP eligibility.
+
+40 Harmonized Tariff Schedule.
+
+ 
+ CRS-14
+
+U.S. exports to Vietnam may increase if Vietnam is designated as a BDC, but
+
+not as quickly as imports. Since the GSP is a non-reciprocal program, acceptance of
+Vietnam as a BDC will not provide similar duty-free treatment for U.S. exporters. In
+2007, the United States exported about $2 billion in goods to Vietnam, up from
+approximately $368 million in 2000. Leading U.S. exports to Vietnam in 2007
+included passenger motor vehicles, cotton, polypropylene, leather, and wheat.
+However, many U.S. manufacturers use imports under GSP (such as wiring
+harnesses, brake and ignition parts, spectacle lenses, and insulated electrical
+conductors) as inputs for finished products that could later be exported to Vietnam
+and other GSP beneficiaries.
+
+ Issues for Congress 
+
+The GSP statute provides the President with the authority to designate any
+
+country a beneficiary developing country, provided the country complies with the
+conditions described in the statute. Therefore, Congress does not need to act to
+approve GSP status for Vietnam. The President is required to notify Congress of his
+intention, however.41
+
+The Generalized System of Preferences program was set to expire on December
+
+31, 2008, but was granted a one-year extension in sec. 4 of H.R. 7222 (passed House
+September 29, 2008, and October 3, 2008; passed Senate October 2, 2008). The
+legislation is awaiting the President’s signature as of this writing.
+
+Congress could also decide to authorize or instruct the President to designate —
+
+or not to designate — Vietnam as a BDC, either as part of the legislation to extend
+the GSP program or in separate legislation. For example, S. 3678, the Vietnam
+Human Rights Act of 2008, would prohibit the grant of GSP status unless the
+President certifies that Vietnam has met certain human rights conditions. In addition,
+Congress could pass legislation stipulating additional criteria for the President to
+consider when deciding to confer BDC status to Vietnam. Such legislation could
+also include specific restrictions on GSP-eligible products for Vietnam and/or the
+size of CNLs.
+
+Over the past decade, Congress has debated a number of issues with respect to
+
+U.S.-Vietnam relations, particularly Vietnam’s growing and increasingly liberalized
+economy and its human rights record. The United States also has a sizeable and
+growing foreign assistance program in Vietnam, and the two countries are expanding
+their strategic relations. All these issues may factor into the debate over GSP
+membership.
+
+41 Under the provisions of 19 U.S.C. 2462(f)(1), the President must notify Congress 60 days
+prior to the designation of a least-developed BDC; no time period is specified for BDC
+designation.
\ No newline at end of file
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new file mode 100644
index 0000000000000000000000000000000000000000..f307b94d652d211c0e5488680842b8718ed76eb7
--- /dev/null
+++ b/corpus/politics/text/e1850cd7bbc0d244.txt
@@ -0,0 +1,2461 @@
+Order Code RL30533
+
+ The Quasi Government: Hybrid Organizations 
+
+ with Both Government and Private Sector 
+
+ Legal Characteristics 
+
+ Updated January 31, 2008 
+
+Kevin R. Kosar
+
+Analyst in American National Government
+
+Government and Finance Division
+
+ 
+ The Quasi Government: Hybrid Organizations with Both
+
+Government and Private Sector Legal Characteristics
+
+ Summary 
+
+This report provides an overview of federally related entities that possess legal
+
+characteristics of both the governmental and private sectors. These hybrid
+organizations (e.g., Fannie Mae, National Park Foundation, In-Q-Tel), collectively
+referred to in this report as the “quasi government,” have grown in number, size, and
+importance in recent decades.
+
+A brief review of executive branch organizational history is followed by a
+
+description of entities with ties to the executive branch, although they are not
+“agencies” of the United States as defined in Title 5 of the U.S. Code . Several
+categories of quasi governmental entities are defined and discussed: (1) quasi official
+agencies, (2) government-sponsored enterprises (GSE), (3) federally funded research
+and development corporations, (4) agency-related nonprofit organizations, (5)
+venture capital funds, (6) congressionally chartered nonprofit organizations, and (7)
+instrumentalities of indeterminate character.
+
+The quasi government, not surprisingly, is a controversial subject. To
+
+supporters of this trend toward greater reliance upon hybrid organizations, the proper
+objective of governmental management is to maximize performance and results,
+however defined. In their view, the private and governmental sectors are alike in
+their essentials, and thus subject to the same economically derived behavioral norms.
+They tend to welcome this trend toward greater use of quasi governmental entities.
+
+Critics of the quasi government, on the other hand, tend to view hybrid
+
+organizations as contributing to a weakened capacity of government to perform its
+fundamental constitutional duties, and to an erosion in political accountability, a
+crucial element in democratic governance. They tend to consider the governmental
+and private sectors as being legally distinct, with relatively little overlap in behavioral
+norms.
+
+Congress is increasingly engaged with the quasi government. The issues run the
+
+gamut from enacting legislation to encourage the creation of nonprofit organizations
+to promote individual national parks, to proposals to strengthen regulation of
+government-sponsored enterprises such as Fannie Mae, to oversight hearings
+respecting national security issues at Los Alamos Laboratory. There is nothing
+modest about the size, scope, and impact of the quasi government.
+
+Time will tell whether the emergence of the quasi government is to be viewed
+
+as a symptom of decline in our democratic government, or a harbinger of a new,
+creative management era where the purportedly artificial barriers between the
+governmental and private sectors are breached as a matter of principle.
+
+This report will be updated at the beginning of each Congress.
+
+ 
+ Contents 
+
+Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+In Search of a Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Spectrum or Categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Federal Organization and Management:
+
+ The Traditional View Under Question . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+
+Quasi Governmental Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+Quasi Official Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Government-Sponsored Enterprises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+Federally Funded Research and Development Centers (FFRDCs) . . . . . . . 14
+Agency-Related Nonprofit Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+
+Adjunct Organizations Under the Control of a Department 
+
+or Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+
+Organizations Independent of, But Dependent Upon, Agencies . . . . . 21
+Nonprofit Organizations Affiliated with Departments or Agencies . . 23
+
+Venture Capital Funds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
+Congressionally Chartered Nonprofit Organizations . . . . . . . . . . . . . . . . . . 28
+Instrumentalities of Indeterminate Character . . . . . . . . . . . . . . . . . . . . . . . . 32
+
+American Institute in Taiwan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
+National Endowment for Democracy . . . . . . . . . . . . . . . . . . . . . . . . . . 33
+U.S. Investigation Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
+
+Conclusion: Paradigms in Conflict . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
+
+ 
+ The Quasi Government: 
+
+Hybrid Organizations with Both 
+
+Government and Private Sector 
+
+Legal Characteristics
+
+ Context 
+
+In recent years, both Congress and the President have increasingly used hybrid
+
+organizations for the implementation of public policy functions traditionally assigned
+to executive departments and agencies.1 Instead, their preference has often been to
+assign administrative responsibilities to newly created independent agencies or to
+hybrid organizations possessing legal characteristics of both the governmental and
+private sectors. Hybrid organizations attract both support and criticism. There are
+today, associated with the federal government alone, hundreds of hybrid entities that
+have collectively been called the “quasi government.”2 The relationship of this
+burgeoning quasi government to elected and appointed officials is a subject of
+growing concern, as it touches the very heart of democratic governance: to whom are
+these hybrids accountable, and how is the public interest being protected over and
+against the interest of private parties?
+
+The scope and consequences of these hybrid organizations have not been
+
+extensively studied. Basic definitional issues resist resolution. Even the language
+to be used in discussing the quasi government is in dispute. Should government
+management be discussed in the language of law, of economic theory, or of the
+business school? The traditional tools for holding executive agencies accountable,
+such as the budget and general management laws, are inapplicable in most instances,
+often leaving these hybrids with the freedom to pursue their own institutional
+interests, which may or may not conform to the public interest as defined by the
+nation’s elected leadership.
+
+The current popularity of the quasi government option can be traced to at least
+
+four major factors at work in the political realm:
+
+(1)
+
+the current controls on the federal budget process that encourage agencies
+to develop new sources of revenues;
+
+1 This report was originally authored by Ronald C. Moe, who retired from CRS. It has been
+revised a number of times by the current author. Readers with questions about quasi
+governmental organizations may contact Kevin R. Kosar.
+
+2 Harold Seidman, “The Quasi World of the Federal Government,” The Brookings Review,
+ vol. 2, Summer 1988, pp. 23-27.
+
+ 
+ CRS-2
+
+(2)
+
+the desire by advocates of agencies and programs to be exempt from central
+management laws, especially statutory ceilings on personnel and
+compensation;
+
+(3)
+
+the contemporary appeal of generic, economic-focused values as the basis
+for a “new public management;” and 
+
+(4)
+
+the belief that management flexibility requires entity-specific laws and
+regulations, even at the cost of less accountability to representative
+institutions.
+
+This report introduces the reader to the quasi government, suggests categories
+
+of entities within this sector, and examines their legal characteristics, behavior, and
+possible policy consequences. The report will be revised and updated as new
+information and analyses become available.
+
+ In Search of a Definition 
+
+The quasi government, virtually by its name alone and the intentional blurring
+
+of the governmental and private sectors, is not easily defined. In general, the term
+is used in two ways: to refer to entities that have some legal relation or association,
+however tenuous, to the federal government; or to the terrain that putatively exists
+between the governmental and private sectors. For the most part, this report will use
+the term quasi government in the former context, referring to entities with some legal
+relationship to the federal government. The one common characteristic to this
+melange of entities in the quasi government is that they are not agencies of the United
+States as that term is defined in Title 5 of the U.S. Code .
+
+If a quasi governmental entity is not an agency of government, what is it? For
+
+this report’s purposes, it is a hybrid organization that has been assigned by law, or by
+general practice, some of the legal characteristics of both the governmental and
+private sectors. While different categories of quasi governmental organizations can
+be described and found useful as an analytic tool, such categories are artificial, with
+porous lines of distinction and differentiation, and tend to be imposed upon the
+disparate entities after the fact. 
+
+ Spectrum or Categories 
+
+Two rough models suggest themselves as ways of looking at these entities.
+
+First, there is the linear spectrum model where the existence of a quasi
+
+government between the governmental and private sectors is designated and
+categories of organizations (e.g., government-sponsored enterprises) and their
+relationship to the executive branch (and Congress) are described on a descending
+scale from closest to the most distant.
+
+Second, there is the categoric organization model involving, in this instance, the
+
+suggestion of four categories: pure government organization; quasi governmental
+organization (“quago”); quasi nongovernmental organization (“quango”); and pure
+private. A quago is essentially a government organization that is assigned some, or
+
+ 
+ CRS-3
+
+many, of the attributes normally associated with the private sector. A quango, on the
+other hand, is essentially a private organization that is assigned some, or many, of the
+attributes normally associated with the governmental sector.3 Under this schema, the
+Legal Services Corporation, for example, would be a quago, while the Red Cross
+would be a quango.
+
+Whatever the value of the quago/quango designations, especially in the
+
+comparative international literature on corporate organizations, it shall not be used
+here. This report follows the linear spectrum approach in describing the elements
+within the quasi government. It is possible to begin with what are referred to in the
+ U.S. Government Manual as “Quasi Official Agencies,” those entities, arguably,
+closest to the executive branch, and move on to the other end of the spectrum,
+“congressionally chartered nonprofit organizations,” those entities, arguably, the
+furthest from the executive branch.
+
+ Federal Organization and Management: 
+
+ The Traditional View Under Question 
+
+It was the intent of the framers of the Constitution that the authority and
+
+organization of the executive branch be as much as possible unified under the
+President, and that Congress be the source to which accountability was rendered.
+This theoretical proposition was put into practice when the first Congress convened
+in 1789. One of the first orders of business was the establishment of executive
+departments. Three “organic” statutes were enacted creating three “great”
+departments; Treasury, State and War.4 The heads of these departments were directly
+responsible to the President and were his agents (and thus the agency chiefs were
+removable by him), but ultimately accountable for policy purposes to Congress. All
+the particular functions of the newly created executive branch, save that of delivering
+the mails, were entrusted to these departments.
+
+With respect to fundamental authorities and lines of accountability, however,
+
+the executive branch has never been a pristine unity. From the decision in the first
+Congress to give the comptroller in the Department of the Treasury a substantial
+
+3 There is a burgeoning comparative international literature on the quasi government as it
+functions today in various countries. In many instances, the literature stresses the problems
+raised by these bodies for democratic theory. Organization for Economic Cooperation and
+Development (OECD), Distributed Public Governance: Agencies, Authorities and Other
+Government Bodies (Paris: OECD, 2002). Matthew Flinders and M.J. Smith, eds., Quango,
+Accountability and Reform: The Politics of the Quasi Government (London: Macmillan,
+1999). S. Weir, “Quangos: Questions of Democratic Accountability,” in F. Ridley and D.
+Wilson, eds., The Quango Debate (London: Oxford University Press, 1995), pp. 128-145;
+and Jonathan G.S. Koppell, The Politics of Quasi Government: Hybrid Organizations and
+the Control of Public Policy (New York: Cambridge University Press, 2003).
+
+4 Discussion of the acts creating the three “great departments” may be found in James Hart,
+ The American Presidency in Action, 1789: A Study in Constitutional History (New York:
+Macmillan, 1948), chapter 7. See also: Leonard D. White, The Federalists: A Study in
+Administrative History (New York: Macmillan, 1948).
+
+ 
+ CRS-4
+
+degree of legal autonomy within the department,5 down to the more recent
+“independent counsels” functioning in an uneasy relationship with the executive
+branch,6 not all officers have been directly accountable to the President.7 These
+exceptions notwithstanding, the prevailing organizational norm has historically been
+toward an executive accountable to the President.8
+
+Reinforcing the hierarchical concept of the accountable executive has been the
+
+view that authority ought to be assigned by delegation from the President or
+department heads to subordinate officers, rather than being assigned directly by
+Congress to a nondepartment head.9 The first substantial breaks with this concept
+did not occur until the creation of the Civil Service Commission in 1883 and the
+Interstate Commerce Commission in 1887. Subsequently, more independent
+regulatory commissions would be added. In the 20th century, an increasing number
+of “independent” agencies were established, the term “independent” meaning that an
+agency was not established within a department (e.g., Tennessee Valley Authority;
+National Aeronautic and Space Administration). Nonetheless, the independent
+agencies generally remained full government agencies operating under all the general
+management laws,10 except where exempted. 
+
+The view that all government activities should be accountable in some manner
+
+to politically responsible officials received its most forceful iteration in the 20th
+century in the Hoover Commission report of 1949: 
+
+5 1 Annals of Congress (1789), p. 614.
+
+6 The federal law governing the appointment of independent counsels expired June 30, 1999.
+CRS Report RL31246, Independent Counsel Law Expiration and the Appointment of
+‘Special Counsels,’ by Jack Maskell. See also Katy J. Harriger, “Separation of Powers and
+the Politics of Independent Counsels,” Political Science Quarterly , vol. 109, Summer 1994,
+pp. 261-86; and Louis Fisher, “The Independent Counsel Statute,” in Mark Rozell and Clyde
+Wilcox , eds., The Clinton Scandal and the Future of American Government (Washington:
+Georgetown University Press, 2000), pp. 60-80.
+
+7 Charles Tiefer, “The Constitutionality of Independent Officers as Checks on Abuses of
+Executive Power,” Boston University Law Review , vol. 63, 1983, pp. 59-103.
+
+8 Peri E. Arnold, Making the Managerial Presidency: Comprehensive Reorganization
+Planning, 1905-1996 , 2nd ed. (Lawrence, KS: University Press of Kansas, 1999). Ronald
+C. Moe, Administrative Renewal: Reorganization Commissions in the 20th Century
+ (Lanham, MD: University Press of America, 2003).
+
+9 In the administration of James Monroe (1817-1825), the President objected to a proposal
+to establish the Patent Office as an agency independent of any executive department. He
+argued that such a proposal would result in a usurpation of his powers as President. “I have
+always thought that every institution of whatever nature soever it might be, ought to be
+comprised within some one of the Departments of the Government, the chief of which only
+should be responsible to the Chief Executive magistrate of the Nation. The establishment
+of inferior independent departments, the heads of which are not, and ought not be, members
+of the administration, appears to me to be liable to many serious objections, which will
+doubtless occur to you.” (2 American State Papers, Mis., p. 192).
+
+10 CRS Report RL30795, General Management Laws: A Compendium , Clinton Brass,
+coordinator.
+
+ 
+ CRS-5
+
+[The] organization and administration of the Government ... must establish a
+clear line of control from the President to these department and agency heads and
+from them to their subordinates with correlative responsibility from these
+officials to the President, cutting through the barriers which in many cases made
+bureaus and agencies partially independent of the Chief Executive.11 
+
+Through the 1950s the organization and management of the executive branch
+
+generally followed some basic rules. If an entity was established by Congress to
+accomplish a public purpose, the probability was that it was an agency of the United
+States operating under the general management laws enforced by the President.
+These values, originating with the founding fathers, as reinterpreted by the
+Progressives, featured the centrality of public law, departmental integration and
+political accountability. The President was viewed as the Chief Manager of the
+administrative system.12 The governmental and private sectors cooperated, but were
+kept legally distinct in the interests of protecting citizens’ rights against a potentially
+arbitrary government.
+
+These values began to be challenged in the 1960s as evidenced in the
+
+establishment of the Communications Satellite Corporation (ComSat) in 1962.
+Congress, in this instance, created a private, for-profit corporation indicating a more
+flexible attitude towards organizational innovation. Additional organizations
+appeared that were intentionally mixed in their legal characteristics. The term “quasi
+governmental” began to appear in legislation, and unusual structures would be
+constructed to promote “flexibility,” even when flexibility sometimes resulted in less
+accountability. This was one of the arguments made for creating the Corporation for
+Public Broadcasting in 1967 (81 Stat. 365; 47 U.S.C. 396).13 Other factors began to
+further erode the accountable executive model, such as greater dependence upon third
+parties, usually private contractors, for the performance of governmental functions.14
+The number of full-time civil servants in the federal government as a percentage of
+the workforce began what was to become a substantial decline, a decline accelerated
+in recent years.15
+
+11 U.S. Commission on Organization of the Executive Branch of the Government, The
+Hoover Commission Report (New York: McGraw-Hill Book Company, 1949), p. 7.
+
+12 Ronald C. Moe, “At Risk: The President’s Role as Chief Manager,” in James Pfiffner, ed.
+ The Managerial Presidency , 2nd ed. (College Station, TX: Texas A&M Press, 1999), pp.
+265-84.
+
+13 Robert K. Avery and Robert Pepper, “An Institutional History of Public Broadcasting,”
+ Journal of Communications , vol. 30, Summer 1980, pp. 126-38.
+
+14 Donald F. Kettl, “Managing Indirect Government,” in Lester M. Salamon, ed., The Tools
+of Government: A Guide to the New Governance (New York: Oxford University Press,
+2002), pp. 490-511.
+
+15 In 1970, federal civilian employment was 2,997,000, or 3.8 percent of the U.S.
+employment total. By 2004, federal civilian employment had been reduced to 2,743,000,
+or 2 percent of the U.S. employment total. U.S. Bureau of the Census, Statistical Abstract
+of the United States (Washington: GPO, 2004), p. 321. Meanwhile, there are at least 7
+million government contractors. See Paul C. Light, The New True Size of Government (New
+Y o r k: N e w Y o r k U n i ve r s i t y, Aug. 2006), p. 11, available at
+[http://wagner.nyu.edu/performance/files/True_Size.pdf].
+
+ 
+ CRS-6
+
+In the late 1980s, the concept of legally distinctive governmental and private
+
+sectors began to be seriously questioned.16 In its place a “new public management”
+concept emerged that argued that the governmental and private sectors were
+essentially alike and subject to the same, economic based, behavioral norms and
+practices. Internationally, the New Public Management (NPM)17 movement, coupled
+with the movement toward privatization of governmental agencies and programs,
+became the reigning orthodoxy. Many elements of NPM were to be found in Vice
+President Al Gore’s National Performance Review (NPR)18 which sought to
+“reinvent” some executive branch units and create corporate style, entrepreneurial
+structures.19 
+
+The purported, and often realized, strength of entrepreneurial management lies
+
+in the flexibility it provides managers to improve the performance of their agencies.
+Performance in the entrepreneurial context, is usually measured in “output” or
+“results” terms, rather than in conformance to process regulations. Hence, risk-
+taking by managers to achieve improved performance is to some degree accepted and
+encouraged. The evidence thus far available suggests that the new, entrepreneurial
+management has resulted in improved management in many executive agencies. On
+the other hand, simply improving performance, as was the case with the Internal
+Revenue Service in the early 1990s, has occasionally proven politically
+counterproductive to the agency if the improved performance (in this case increased
+tax collections) came at the apparent expense of other values, such as due process of
+
+16 See, for example: Barry Bozeman, All Organizations Are Public: Bridging Public and
+Private Organizational Theories (San Francisco: Jossey-Boss, 1987); Robert D. Behn,
+ Rethinking Democratic Accountability (Washington: Brookings Institution, 2001); Ronald
+C. Moe, “The Emerging Federal Quasi Government: Issues of Management and
+Accountability,” Public Administration Review , vol. 61, May/June 2001, pp. 290-312.
+
+17 The term “New Public Management” (NPM) gained currency in part through its use by
+the Organization for Economic Cooperation and Development (OECD) to refer to the
+literature, propositions, and practices promoting conceptual convergence of the
+governmental and private sector management. OECD, Governance in Transition: Public
+Management Reforms in OECD Countries (Paris: OECD, 1995); and Larry Terry,
+“Administrative Leadership, Neo-Managerialism, and the Public Management Movement,”
+ Public Administration Review , vol. 58, May/June 1998, pp. 194-200. 
+
+18 The term National Performance Review (NPR) refers both to a report and to an
+organization. In 1993, under Vice President Al Gore’s leadership, the NPR issued a report
+titled: From Red Tape to Results: Creating a Government That Works Better and Costs Less
+ (Washington: GPO, 1993). The NPR, a nonstatutory organization, continued to issue
+reports through 1997 (e.g., Businesslike Government: Lessons Learned from America’s Best
+ Companies , 1997). In 1998, the NPR organization changed its name to the National
+Partnership for Reinventing Government. For a critical overview of the “reinventing
+government” exercise, see Michael E. Norris, Reinventing the Administrative State
+ (Lanham, MD: University Press of America, 2000).
+
+19 “Public entrepreneurship is a management approach developed by the reinventing
+government movement.... The transformation of existing, outdated bureaucratic
+organizations into agile, anticipatory, problem-solving entities is what reinventionists call
+‘entrepreneurial government.’” Steven Cohen and William Eimicke, “Is Public
+Entrepreneurship Ethical? A Second Look at Theory and Practice,” Public Integrity , vol.
+1, Winter 1999, p. 55.
+
+ 
+ CRS-7
+
+law. The rapid ascendency of these “new” values in the United States has not been
+without challenge20 and has had consequences with respect to the quasi government,
+as will be discussed more fully later in the report.
+
+ Quasi Governmental Organizations 
+
+ Quasi Official Agencies 
+
+Within the quasi government, it is possible to begin with those entities that are,
+
+arguably, closest to the executive branch. The United States Government Manual,
+2006-2007 , contains a section titled; “Quasi Official Agencies,” listing some four
+entities: Legal Services Corporation; the Smithsonian Institution; State Justice
+Institute; and the United States Institute of Peace. In prior years, other entities have
+been accorded this designation, for example, the National Railroad Passenger
+Corporation (AMTRAK); the National Consumer Cooperative Bank; and the
+National Academy of Sciences. The category is something of a “catchall”
+designation to include entities the National Archives and Records Administration
+(NARA), compilers of the Manual , find difficult to comfortably fit elsewhere.
+Insofar as NARA provides a defining characteristic for quasi official agencies, it is
+that they “are not agencies under the definition of 5 U.S.C. 105 but are required by
+statute to publish certain information on their programs and activities in the Federal
+Register, ” also published by NARA.21
+
+The issues associated with quasi official agencies tend to be related to their legal
+
+status. Because they occupy a realm between the private and the public, a quasi
+governmental entity may find it in its interest to assert its private or governmental
+status. Quasi official agencies, like other elements of the quasi government, may
+exist in what has been called “the twilight zone” between the governmental and
+private sectors.22 This status, while presumably permitting considerable autonomy
+from regular lines of accountability to managerial agencies (e.g., the Government
+Accountability Office) is not, as is often argued in their defense, protection from
+“political influences.” Quasi official agencies, like other forms of quasi governmental
+
+20 The debate between those supporting the entrepreneurial government management
+paradigm and those supporting a public law management paradigm occupies a good deal of
+the current public management literature. See, for example: David Osborne and Ted
+Gaebler, Reinventing Government: How the Entrepreneurial Spirit is Transforming the
+Public Sector from Schoolhouse to State House, City Hall to the Pentagon (Reading, MA:
+Addison Wesley, 1992); H. George Frederickson, The Spirit of Public Administration (San
+Francisco: Jossey-Bass, 1997); and Ronald C. Moe, “The Importance of Public Law: New
+and Old Paradigms of Government Management,” in Phillip J. Cooper and Chester A.
+Newland, eds., Handbook of Public Law and Administration (San Francisco: Jossey-Bass,
+1997), 41-57.
+
+21 U.S. Office of the Federal Register, National Archives and Records Administration,
+ United States Government Manual, 2006-2007 (Washington: GPO, 2006), p. 555.
+
+22 Harold Seidman, Politics, Position and Power: the Dynamics of Federal Organization ,
+2nd ed. (Oxford University Press, 1975), ch. 9.
+
+ 
+ CRS-8
+
+institutions, may sometimes be highly “political,” and subject to pressures not
+dissimilar to that encountered by regular executive agencies.23
+
+ Government-Sponsored Enterprises 
+
+Distinctions between the governmental and private sectors are especially blurred
+
+with respect to a category of organization known as “government-sponsored
+enterprises” (GSE). There is no established criteria defining standards to be met
+prior to the establishment of a GSE, nor is there a listing of GSEs in the U.S. Code.
+Each GSE is created sui generis with its attributes defined by Congress in its
+enabling legislation. For the purpose of budgetary treatment, Congress has defined
+the term “government-sponsored enterprise” in the Omnibus Reconciliation Act of
+1990 to refer to 
+
+a corporate entity created by a law of the United States that — 
+(A) (i) has a Federal charter authorized by law;
+
+(ii) is privately owned, as evidenced by capital stock owned by private
+
+entities or individuals;
+
+(iii) is under the direction of a board of directors, a majority of which is
+
+elected by private owners;
+
+(iv) is a financial institution with power to — 
+
+(I) make loans or loan guarantees for limited purposes such as to
+
+provide credit for specific borrowers or one sector; and
+
+(II) raise funds by borrowing (which does not carry the full faith and
+credit of the Federal Government) or to guarantee the debt of others
+in unlimited amounts; and
+
+(B) (i) does not exercise powers that are reserved to the Government as 
+sovereign (such as the power to tax or to regulate interstate commerce);
+
+(ii) does not have the power to commit the Government financially (but it
+may be a recipient of a loan guarantee commitment made by the 
+
+Government); and
+
+(iii) has employees whose salaries and expenses are paid by the enterprise
+and are not Federal employees subject to title 5.24 
+
+23 One argument often made when proposing independence, autonomy, or quasi
+governmental status for an agency is that such a move will result in less political and interest
+group pressures being brought to bear on the agency. That such an assertion is often not the
+case is illustrated by a study of the Social Security Administration (SSA), made independent
+of the Department of Health and Human Services (HHS) in 1994. “Few if any putative
+benefits from reorganization have been realized by the SSA. Removing the agency from
+HHS has meant, of course, independence from the agency’s policy tendencies, but it has left
+the SSA more exposed to its various clientele or constituency groups and to congressional
+and executive branch politics of divided government.” David G. Smith, “Organizational
+Models for Restructuring Fee-for-Service Medicare,” in Robert D. Reischauer, Stuart Butler,
+and Judith Lave, eds., Medicare: Preparing for the Challenges of the 21st Century
+ (Washington: National Academy of Social Insurance, 1998), p. 230; and J.L. Mashaw,
+“Reinventing Government and Regulatory Reform, Studies in the Neglect and Abuse of
+Administrative Law,” University of Pittsburgh Law Review , vol. 57, 1996, pp. 405-22.
+
+24 104 Stat. 1388-607, Sec. 13112; 2 U.S.C. 622(8). 
+
+ 
+ CRS-9
+
+Few scholars of public administration and finance are likely to argue that this
+definition is incorrect. However, some have argued that the above definition omits
+an essential characteristic — a GSE “benefits from an implicit federal guarantee to
+enhance its ability to borrow money.”25 
+
+Historically, the federal government has been involved in few commercial
+
+enterprises on an equity basis. There were some early instances of the federal
+government participating in otherwise private corporate enterprises on a shared
+ownership basis, most notably the first and second Bank of the United States.26 This
+practice came into question, however, as a consequence of a Supreme Court ruling
+in 1819.27 From that time to the present, the federal government, with few
+exceptions, has consciously avoided shared ownership involvement with private,
+nongovernmental entities. 
+
+Congress created GSEs to help make credit more readily available to sectors of
+
+the economy believed to be disadvantaged in the credit markets.28 There are
+presently five GSEs, properly defined. Three of the GSEs — Federal National
+Mortgage Association (Fannie Mae), Federal Home Loan Mortgage Corporation
+(Freddie Mac), and the Federal Agricultural Mortgage Corporation (Farmer Mac) —
+are investor owned; the two others — the Federal Home Loan Bank System and the
+Farm Credit System — are owned cooperatively by their borrowers. In addition, two
+institutions — the Financing Corporation and the Resolution Funding Corporation
+— are governmental bodies that were given GSE status so that their funding would
+not appear to be federal borrowing for purposes of the federal budget. Finally, one
+well-known GSE, Sallie Mae (Student Loan Marketing Association), has recently
+shed its GSE status and become a wholly private firm.29
+
+25 Ronald C. Moe and Thomas H. Stanton, “Government-Sponsored Enterprises as Federal
+Instrumentalities: Reconciling Private Management with Public Accountability,” Public
+Administration Review , vol. 49, July/Aug. 1989, p. 321.
+
+26 Bray Hammond, Banks and Politics in America From the Revolution to the Civil War
+ (Princeton, NJ: Princeton University Press, 1957); John T. Holdsworth and David Dewey,
+ The First and Second Banks of the United States , S. Doc. 571, 61st Cong., 2nd sess.
+(Washington: GPO, 1910); and Leonard D. White, The Jacksonians (New York: Macmillan,
+1954), chapter 24.
+
+27 McCulloch v. Maryland (17 U.S. (4 Wheat.) 315, (1819)). The Supreme Court’s ruling
+implied that partial federal ownership of a corporation, in this instance the Bank of the
+United States, assigned the corporation certain attributes normally reserved to the sovereign
+authority (e.g., non-taxable status in the several states). See also: Osborn v. Bank of the
+United States (17 U.S. (4 Wheat.) 738, (1824)).
+
+28 Thomas H. Stanton, Government Sponsored Enterprises: Mercantilist Companies in the
+Modern World (Washington: AEI, 2002). 
+
+29 J. E. Dean, S. L. Moskowitz, and K. L. Cipriani, “Implications of Privatization of Sallie
+Mae,” Journal of Public Budgeting, Accounting and Financial Management, vol. 11, Spring
+1999, pp. 56-80; and J. Kevin Corder and Susan M. Hoffman, “Privatizing Federal Credit
+Programs: Why Sallie Mae?” Public Administration Review, vol. 64, March/April 2004, pp.
+180-191.
+
+ 
+ CRS-10
+
+Defenders of the current GSEs and the economic concepts upon which they are
+
+based argue that GSEs continue to meet a national need that would not otherwise be
+met or be met poorly by corporations fully in the private sector. Further, they
+contend that the current GSEs are generally well managed, financially sound, and
+assist less-advantaged mortgage borrowers. They maintain that the subsidy retained
+from the presence of the federal implied guarantee of GSE obligations is passed on
+to the consumer in the form of lower mortgage rates. Fannie Mae, in its national
+advertising campaign, suggests that its special GSE status is worth a quarter of a
+percent in mortgage interest and thus 400,000 families are provided mortgages that
+would not otherwise be qualified to do so. “At Fannie Mae, we have one job. One
+mission. One purpose. To do whatever we can to lower the cost of home
+ownership.”30
+
+Contemporary GSEs are part of a tradition of mercantilist financial institutions
+
+in that the government assigns them benefits and privileges in their charters that are
+not available to fully private corporations.31 In return, the government is able to limit
+the activities and lines of business of GSEs and require them to promote selected
+public policy objectives. The present GSEs are traceable in concept to several
+enterprises created during the Great Depression.32 GSEs provide financial services
+such as issuing capital stock and short and long term debt instruments, guaranteeing
+mortgage-backed securities (MBS), purchasing loans and holding them in their own
+portfolio, funding activities (e.g., subsidized mortgages in selected areas), and
+collecting fees for guarantees and other services.33 
+
+While the details may vary from one instance to the next, Congress provides that
+
+GSEs typically have four characteristics:
+
+! private ownership;
+! implicit federal guarantee of obligations;
+! activities limited by congressional charter; and
+! limited competition.
+
+The economic rationale for GSEs is the belief that without such a government
+
+sponsored institution, a critical area of necessary debt financing would go unserved,
+or would be serviced at an expensive or inefficient level. Government, according to
+this rationale, should use some of its sovereign powers (e.g., full faith and credit of
+the U.S. Treasury) to encourage the development of private financial intermediaries
+
+30 Fannie Mae advertisement, Washington Post, May 11, 1999, p. A4.
+
+31 Thomas H. Stanton, “Nonquantifiable Risks and Financial Institutions: The Mercantilist
+Legal Framework of Banks, Thrifts, and Government-Sponsored Enterprises,” in Charles
+A. Stone and Anne Zissu, eds., Global Risk-Based Capital Regulations (Burr Ridge, IL:
+Irwin Professional Publishing, 1994), vol. 1, pp. 57-97.
+
+32 The Farm Credit Banks, however, pre-date the Depression, having been established in
+1916. (39 Stat. 360). 
+
+33 U.S. General Accounting Office, Financial Services Institutions: Information for
+Assessing the Government’s Potential Financial Exposure, GAO/GGD-98-125,
+(Washington: GAO, 1998), p. 3.
+
+ 
+ CRS-11
+
+to serve selected markets. In terms of meeting their original congressional objective,
+that was to liquify the mortgage credit markets on a national rather than regional or
+state basis, the GSEs have been remarkably successful. But with this success have
+come reservations and questions.
+
+There is nothing modest about the size and scope of GSEs. Due to the implicit
+
+federal backing for their notes,34 GSEs have become some of the largest financial
+institutions in the United States. In 2005, Freddie Mac reported outstanding debt of
+nearly $749 billion; in 2003, Fannie Mae reported outstanding debt of approximately
+$962 billion.35 Meanwhile, the Federal Home Loan Bank System reported $816
+billion in consolidated debt outstanding in mid-200436.
+ 
+
+Two issues stand out when discussing the finances of GSEs; safety and
+
+soundness, and the utility and accountability resulting from their status as a
+government instrumentality. GSEs primarily act as financial intermediaries to assist
+borrowers in housing, education, and agriculture. Although they are privately owned,
+they benefit financially from government sponsorship. Their securities can
+collateralize public deposits (e.g., Social Security Administration deposits), and can
+be held in unlimited amounts by most banks and thrifts. They are not subject, with
+one exception (Farmer Mac), to Securities and Exchange Commission (SEC)
+registration,37 and their corporate earnings are exempt from state and local income
+taxes, the latter practice attracting particular controversy.38 They may borrow
+virtually unlimited amounts of money in the federal agency credit market on
+favorable terms and directly from the Treasury, at the latter’s discretion. Most
+importantly, the credit market perceives this federal sponsorship as an implied federal
+guarantee of their corporate debt and obligations. These factors enable GSEs to
+borrow monies at a significantly lower interest rate than competitors. Reviewing
+
+34 There is no explicit guarantee in law for GSE liabilities. Whether correct or not, the
+specific liabilities incurred by GSEs are considered by the market as contingent or potential
+liabilities of the federal government. There is a general presumption that the federal
+government would not let the GSEs fail and declare bankruptcy. 
+
+35 Due to accounting difficulties at Fannie Mae, the most recent data available are from
+2003. Office of Federal Housing Enterprise Oversight, 2006 OFHEO Report to Congress
+ (Washington: OFHEO: 2006), Tables 14 and 4, respectively, available at
+[http://www.ofheo.gov/media/pdf/annualreport2006.pdf].
+
+36 Office of Finance, Federal Home Loan Banks, Federal Home Loan Banks (Reston, VA:
+FHLB, 2004), p. 24, available at [http://www.fhlb-of.com/specialinterest/
+finreportframe.html].
+
+37 In July 2002, Fannie Mae and Freddie Mac announced they would voluntarily register
+their common stock with the SEC. CRS Report RS2163, Fannie Mae, Freddie Mac, and
+the SEC Registration and Disclosures , by Mark Jickling and Barbara Miles.
+
+38 CRS (archived) Report 95-952E, Unfunded Mandates and State Taxation of the Income
+of Fannie Mae, Freddie Mac, and Sallie Mae: Implications for D.C. Finances, by Dennis
+Zimmerman, available from the author of this report.
+
+ 
+ CRS-12
+
+these special privileges (subsidies), it is not surprising that some argue that GSEs
+grow rapidly at the expense of would-be competitors.39
+
+Despite their successes, GSEs have faced operational turbulence. In 1988, the
+
+federal government thought it prudent to authorize $8 billion of financial assistance
+for one insolvent GSE, the Farm Credit System. Also, Fannie Mae was in trouble in
+the early 1980s, when its capitalization dropped until the corporation had a negative
+net worth of $11 billion. These instances, plus the sheer size and growth of a
+putative unfunded liability upon the Treasury, has prompted some to be concerned
+about the risks GSEs pose to the political as well as economic system. As early as
+1991, Thomas Stanton voiced the opinion that:
+
+Such huge institutions represent an uncomfortable concentration of risk. If
+anything happens to management quality or prudence (for example, if Fannie
+Mae is again tempted to play the interest-rate yield curve or if a lower-quality
+management team took control of one of the enterprises), the financial
+consequences could rival those of the thrift industry. The federal government is
+clearly better protected if it diversifies this kind of risk.40 
+
+GSEs also have been accused of mission creep. GAO has questioned the
+
+housing GSEs for moving into non-mortgage investment programs.41 
+
+In recent years, both Congress and the housing GSE regulator (the Office of
+
+Federal Housing Enterprise Oversight (OFHEO) have expressed concern respecting
+the size, the systemic risk to the nation’s financial system, and the accounting
+practices of the GSEs.42 Concern over the condition of the housing GSEs was
+heightened in 2003 and 2004 when significant accounting irregularities were
+discovered at both Freddie Mac and Fannie Mae. Both companies had to restate their
+
+39 U.S. Congressional Budget Office, Assessing the Public Costs and Benefits of Fannie Mae
+and Freddie Mac, (Washington: CBO, 1996), p. xii. The value of the subsidy has been a
+source of intense debate between the GSEs and their overseers. CBO reported that the
+subsidy was worth $23 billion in 2003, up almost 70 percent from $13.6 billion in 2000.
+With respect to Fannie Mae and Freddie Mac, CBO estimated that they retained $6.2 billion
+of the perceived subsidy while $13.6 billion was passed along to borrowers in the form of
+lower mortgage costs. Congressional Budget Office, Updated Estimate of the Subsidies of
+the Housing GSEs (Washington, CBO: April 2004).
+
+40 Stanton, A State of Risk , p. 196.
+
+41 U.S. General Accounting Office, Federal Oversight Needed in Nonmortgage Investments ,
+GAO/GGD-98-48 (Washington: GAO, 1998). A number of critics believe that GSEs have
+accomplished their original purpose to rectify imperfections in the secondary mortgage
+market and are no longer necessary or desirable. These individuals tend to advocate
+privatizing the GSEs and allowing them to compete against private firms. For example, see
+Peter J. Wallison et. al., Privatizing Fannie Mae, Freddie Mac, and the Federal Home Loan
+Banks: How and Why (Washington: The AEI Press, 2004).
+
+42 CRS Report RL32069, Improving the Effectiveness of GSE Oversight: Legislative
+Proposals by Loretta Nott and Mark Jickling; and CRS Report RL32795, Government-
+Sponsored Enterprises: Regulatory Reform Legislation in the 109th Congress , by Mark
+Jickling, pp. 2-3.
+
+ 
+ CRS-13
+
+earnings.43 In response, the 108th and 109th Congresses held hearings and considered
+legislation that would fundamentally alter the regulations and regulatory agencies for
+overseeing GSEs. 44
+
+The political accountability issues raised by GSEs’ hybrid character resist
+
+generalization. GSEs are instrumentalities, not agencies, of the United States and
+this distinction is both legally and administratively important. The federal
+government’s control over an institution differs significantly depending upon whether
+that institution is an agency or instrumentality. 
+
+An agency (as defined in Title 5) is managed directly through the federal
+
+management hierarchy. As a general rule, an agency is subject to all general
+management laws and regulations provided in the U.S. Code unless exempted from
+such coverage in either its enabling statute, or by virtue of being part of an exempted
+class of agency. Thus, an agency is subject to federal appointment of its senior
+officers (often requiring Senate confirmation), to civil service and federal
+procurement laws, and to the federal budget and other direct federal management
+controls, unless exempted. 
+
+An instrumentality of government, on the other hand, is a privately-owned
+
+institution not subject to any of the general management laws and regulation unless
+so indicated in its enabling legislation (charter). An instrumentality is assigned in its
+charter limited prerogatives (e.g., immunity from state taxation) normally associated
+with the government’s sovereign authority. In return for this limited assignment of
+governmental powers, an instrumentality cannot on its own authority alter the charter
+or conduct activities contrary to the intent of the charter. A GSE is supervised but
+not directly managed by the federal government.
+
+Primary accountability of GSE management is not to the federal government,
+
+or to the borrowers, but to the corporation’s shareholders. Investors come first. As
+Sallie Mae’s then-Chief Executive Officer told a Senate oversight subcommittee
+some years ago: “We are a private corporation and as such, with stockholders and
+bondholders, we have a fiduciary responsibility to those individuals .... We are not
+charged with subsidizing the guaranteed student loan program or subsidizing the
+students.”45
+
+43 CRS Report RS1567, Accounting and Management Problems at Freddie Mac , by Mark
+Jickling; and CRS Report RS21949, Accounting Problems at Fannie Mae , by Mark Jickling.
+
+44 In testimony before the Senate Banking Committee, Federal Reserve Board Chairman
+Alan Greenspan, noted a paradox facing Congress in “fixing” the regulatory apparatus for
+GSEs. “[W]orld-class regulation, by itself, may even worsen the situation if market
+participants infer from such regulation that the government is all the more likely to back
+GSE debt.” Testimony of the Alan Greenspan, Chairman, Board of Governors of the
+Federal Reserve System, in U.S. Congress, Senate Committee on Banking, Housing, and
+Urban Affairs, Proposals for Improving the Regulation of the Housing Government
+Sponsored Enterprises , hearings, 108th Cong., 2nd sess., Feb. 24, 2004, p. 9.
+
+45 Statement of Edward A. Fox, President and CEO of Sallie Mae, before the Subcommittee
+on Education, Arts and Humanities, Committee on Labor and Human Resources of the U.S.
+
+(continued...)
+
+ 
+ CRS-14
+
+The accountability issue for GSEs, and for much of the quasi government,
+
+involves the allocation of benefits and risks between private parties and the federal
+government and taxpayer. One observer, Harold Seidman, has remarked:
+“Intermingling of public and private purposes in a profit making corporation almost
+inevitably means subordination of public responsibilities to corporate goals. We run
+the danger of creating a system in which we privatize profits and socialize losses.”46
+Supporters would respond to this assertion by contending whatever profits they make
+are ultimately returned to benefit the public through lower mortgage rates. 
+
+ Federally Funded Research and Development 
+Centers (FFRDCs) 
+
+One category of organization in the quasi government is largely a World War
+
+II and immediate postwar phenomenon, the federally funded research and
+development center (FFRDC).47 The FFRDC is a hybrid organization designed to
+meet a federal need through the use of private organizations. In World War II, there
+was a national emergency requirement that scientific and engineering talent be
+rapidly assembled and put to work. National laboratories such as those at Oak Ridge
+and Los Alamos were created to be government owned, but operated by non-federal
+organizations which were not fettered by civil service rules or most general
+management laws. Under wartime conditions, these government-owned, contractor
+operated (GOCO) facilities worked quite well. Immediately after the war, the new
+Department of Defense, and particularly the Air Force, was reluctant to part with this
+talent base they had assembled, and sought ways and means to keep them in service
+to the government. The decision was to establish some private, nonprofit
+corporations to do contract work for the Armed Services. These corporations would
+be solely or largely dependent upon the federal government contracted projects.
+
+The first FFRDC was RAND, created by the Air Force in California in 1947.48
+
+This pioneer was followed over the years by such well-known FFRDCs as Mitre
+Corporation, Aerospace, and the Institute for Defense Analyses. Of the 37 FFRDCs
+functioning in 2006 (down from 41 in 1988), most were established in the 1950s and
+1960s.49 Various FFRDCs have ceased to be listed, although not all those unlisted
+have ceased to exist; in several instances they have been transformed into private
+
+45 (...continued)
+Senate, Oversight of Student Loan Marketing Association (Sallie Mae), Hearings, 102nd
+Cong., 2nd sess. (Washington: GPO, 1982), p. 135.
+
+46 Harold Seidman, Politics, Position, and Power: The Dynamics of Federal Organization,
+ 5th ed. (New York: Oxford University Press, 1998), p. 213.
+
+47 For a brief history of FFRDCs, consult: James S. Hostetler, Federally Funded Research
+and Development Centers: A Proper Role in the 1990s (Vienna, VA: Professional Services
+Council, 1990).
+
+48 Bruce L. R. Smith, The RAND Corporation: A Case Study of a Nonprofit Advisory
+Corporation (Cambridge, MA: Harvard University Press, 1966).
+
+49 A list of FFRDCs may be found in Ronald L. Meeks, Master Government List of
+Federally Funded R&D Centers (Washington: National Science Foundation, 2006),
+available at [http://www.nsf.gov/statistics/nsf06316/]. 
+
+ 
+ CRS-15
+
+organizations. This, though, does not mean that FFRDCs are fading away. In the
+past decade, a new FFRDC was established by the Internal Revenue Service and
+Congress authorized the Department of Homeland Security to establish an FFRDC
+(P.L. 107-396, Title III).50 Although the Departments of Defense and Energy account
+for the bulk of the FFRDCs, other federal entities have FFRDCs, including the
+National Science Foundation, the Federal Aviation Administration, and the
+Department of Homeland Security, to name just a few. According to the most up-to-
+date data available, annual federal obligations to FFRDCs were approximately $7-$8
+billion in FY2003, FY2004, and FY2005.51 
+ 
+
+Critics have complained that FFRDCs provide fertile grounds for activities that
+
+inappropriately mix public funds and private interests. Critics see favoritism when
+FFRDCs receive large contracts without competitive bidding. Critics have also
+pointed to the interflow of personnel between government agencies, FFRDCs, and
+companies that work for FFRDCs. Critics say there is a revolving door between
+these entities and they decry “interlocking directorships” that arise (such as when a
+former Secretary of Defense took board positions at RAND and General Dynamics
+Corp.)52 This latter charge is particularly significant because FFRDCs are supposed
+to be expertise-based organizations that are to impartially oversee the use of federal
+funds that are to advance a governmental purpose.
+
+The great strength of FFRDCs appears to lie in their flexibility to assemble
+
+teams of technical experts on a project basis. High on the list of positive results
+supporters claim for FFRDCs is their ability to promote technology transfers between
+the governmental and private sectors. The knowledge base created by the agencies’
+use of FFRDCs often serves as a foundation for commercially relevant efforts in the
+private sector. The U.S., many contend, is not as effective as other nations in taking
+the results of basic research and transforming them into commercially viable products
+to be sold in world markets.53 FFRDCs are intended to promote and facilitate this
+transfer and development process. 
+
+Congress has been interested in FFRDCs almost from their inception. Some in
+
+Congress have viewed the FFRDCs as a means to circumvent civil service hiring
+practices and salary limitations. While they operate as nonprofit entities, FFRDCs
+
+50 Mitre IRS FFRDC website, available at [http://www.mitre.org/about/ffrdcs/cem/
+about/overview.html]; and CRS Report RS21542, Department of Homeland Security: Issues
+Concerning the Establishment of Federally Funded Research and Development Centers
+(FFRDCs) , by Michael E. Davey.
+
+51 National Science Foundation, Division of Science Resources Statistics, Federal Funds for
+Research and Development: Fiscal Years 2003 — 05 , NSF 06-313, Project Officer, Ronald
+L. Meeks (Arlington, VA: NSF, 2006), Tables 11-13, available at [http://www.nsf.gov/
+statistics/nsf06313/tables.htm#group1].
+
+52 Steven Pearlstein, “Reining In Pentagon’s Think Tanks,” Washington Post, July 28, 1991,
+p. H-1.
+
+53 CRS Report RL33527, Technology Transfer: Use of Federally Funded Research and
+Development , by Wendy H. Schacht; and Michael M Crow, Mark A. Emmert, and Carol I.
+Jacobson, “Government-Supported Industrial Research Institutes in the United States,”
+ Policy Studies Journal , vol. 19, Fall 1999, pp. 59-74.
+
+ 
+ CRS-16
+
+can be a substantial source of revenue for associations and contractors, and there
+have been problems with conflict of interest issues.54 FFRDCs are often difficult to
+hold accountable. They can have an advantage in competing with private firms for
+contracts: as nonprofit corporations, they are exempt from most taxation; their
+facilities and equipment are owned or financed, for the most part, by the federal
+government, and they receive fees for operating expenses without having to assume
+business risks or costs associated with competing for most federal work. 
+
+Questions by Congress have led to hearings, warnings, and some changes in law
+
+(e.g., Competition in Contracting Act of 1984; 98 Stat. 1175) that reduced the scope
+of contract work available to FFRDCs, making more outsourced work available to
+competitive contracting. Also, Congress has limited the power of the Secretaries of
+Defense, Army, Navy, Airforce, and the heads of some other agencies to create
+FFRDCs (10 U.S.C. 2367). 
+
+Unusual and sensitive issues of conflict of interest may be present with
+
+FFRDCs, particularly when a FFRDC is an affiliate of a non-FFRDC corporation.
+FFRDCs often have privileged access to government information, plans, data,
+employees, and facilities which may be difficult to insulate from private partners
+involved in for-profit activities. Critics maintain that unbiased advice may also be
+difficult to provide when the future or fate of the advising FFRDC may be adversely
+affected.
+
+Federal management of FFRDCs is based upon the Federal Acquisition
+
+Regulation (FAR, 35.017). FAR provides guidelines to be followed in establishing,
+organizing, and managing FFRDCs and limits agencies’ use of FFRDCs to meet
+“some long-term research or development need which cannot be met effectively by
+existing in-house or contractor resources.” (FAR, 35.017)
+
+ Agency-Related Nonprofit Organizations 
+
+The term, “agency-related nonprofit corporations,” represents an attempt to
+
+classify under one heading a number of different types of organizations that share one
+characteristic: a legal relationship with a department or agency of the federal
+government. These relations may differ greatly from one situation and organization
+to the next. To assist our review, however, nonprofit organizations with legal
+relationships to departments and agencies will be considered under three categories:
+(1) adjunct organizations under the control of a department or agency; (2)
+organizations independent of, but dependent upon, departments and agencies; and
+(3) nonprofit organizations voluntarily affiliated with departments and agencies.
+Generally, the latter category of organizations are established under state or District
+of Columbia law. These three categories are not pure by any means. While these
+distinctions have an arbitrary character imposed after the fact, there is nonetheless
+some utility in beginning the review of the agency-related nonprofit organization
+category within the quasi government as being of three essential types.
+
+54 E.g., interlocking directorships and the co-mingling of FFRDC and contractor interests
+in ways that compromise the FFRDC’s objectivity in overseeing the contractor work. 
+
+ 
+ CRS-17
+
+ Adjunct Organizations Under the Control of a Department or 
+
+ Agency. There are, at this point, an indeterminate number of organizations under
+the control of a department or agency; this review must therefore be illustrative,
+rather than comprehensive. Nonetheless, a survey of several such departmental or
+agency controlled organizations facilitates an understanding of the scope and nature
+of such organizations.
+
+The Department of Agriculture makes extensive use of adjunct organizations.
+
+Congress has chartered through statute at least 17 agricultural commodity
+organizations (e.g., National Pork Board, National Dairy Promotion and Research
+Board).55 These entities engage in the generic promotion of, research on, and
+information activities for agricultural commodities, thereby, it is hoped, increasing
+the total market for a commodity separate from the promotion of any specific brand
+name of that commodity. The Secretary of Agriculture is assigned varying degrees
+of authority over these boards individually. In an effort to make uniform the
+oversight of such boards and the processes for creating additional boards, Congress
+passed the Commodity Promotion, Research, and Information Act of 1996 (P.L. 104-
+127; 7 U.S.C. 7411).
+
+The law permits the Secretary to establish new commodity organizations
+
+(usually referred to as “boards” or councils”) under departmental orders. The
+Commodity Promotion Act of 1996 is similar to a general incorporation act
+containing specific provisions to be included in the individual charters approved by
+the Secretary.
+
+The provisions in the act respecting the annual activities and budget of the
+
+boards illustrate the type and level of secretarial and agency involvement with the
+boards.
+
+SEC. 515 (e) Activities and Budgets — 
+
+(1) ACTIVITIES — Each [secretarial order to create a board] shall require
+
+the board established under the order to submit to the Secretary for approval
+plans and projects for promotion, research, or information relating to the
+agricultural commodity covered by the order.
+
+(2) BUDGETS — 
+
+(A) SUBMISSION TO SECRETARY — Each order shall require the
+
+board established under the order to submit to the Secretary for approval
+a budget of its anticipated annual expenses and disbursements to be paid to
+administer the order. The budget shall be submitted before the beginning
+of the fiscal year and as frequently as may be necessary after the beginning
+of the fiscal year.
+
+(B) REIMBURSEMENT OF SECRETARY — Each order shall
+
+require that the Secretary be reimbursed for all expenses incurred by the
+Secretary in the implementation, administration, and supervision of the
+order, including all referenda costs incurred in connection with the order.
+
+The concept behind these “independent” boards and councils is to encourage the
+
+commodity interests themselves to organize and propose to the Secretary that such
+
+55 CRS Report 95-353, Federal Farm Promotion (“Check-Off”) Programs , by Geoffrey S.
+Becker.
+
+ 
+ CRS-18
+
+an organization be chartered to promote a product (e.g., milk) generically, rather then
+by brand-name. These boards and councils are authorized by law to finance their
+activities by collecting “assessments” from members according to a rate structure that
+has received the approval of the Secretary. Once a producer is in one of the
+commodity promotion organizations, however, it is difficult to withdraw or ignore
+the assessments.56
+
+The element of private influence and ultimate participation in these hybrid
+
+organizations resides in an elaborate process of referenda. As a practical matter, the
+commodity promotion organizations are under the supervision of the Agricultural
+Marketing Service (AMS), a relatively small unit within the department. The
+referendum provisions of the 1996 Act are detailed. The boards are not established
+in perpetuity, but must be subject to renewal referenda no later than seven years after
+assessments first begin. Even the definition of a majority is complex. For instance,
+the referendum majority provides : “A [secretarial] order may provide for its approval
+in a referendum — (1) by a majority of those persons voting; (2) by persons voting
+for approval who represent a majority of the volume of the agricultural commodity;
+or (3) by a majority of those persons voting for approval who also represent a
+majority of the volume of the agricultural commodity.” Advance registration
+procedures are spelled out in the law, thereby requiring subsequent changes to also
+be made by law. Finally, it is the AMS that is charged with helping the boards
+administer the referendum process.
+
+Notwithstanding this mandated oversight, the promotion programs, which cost
+
+producers and importers hundreds of millions of dollars a year,57 have been criticized
+by policy opponents and media critics for inappropriate spending, lax accounting,
+and lavish entertainments.58 One consequence of this publicity was that the Secretary
+instituted a task force to make recommendations on how the department might better
+oversee the boards and their programs. The report, issued in December 1999, called
+for implementation of 21 recommendations, all of which then-Secretary Dan
+Glickman endorsed. Proposed changes were submitted to the Federal Register for
+public comment on December 17, 1999, but as of spring 2005 have not been formally
+adopted.59 
+
+56 William Claiborne, “Hog Farmers Given Vote on Marketing Fee Rules,” Washington
+Post , Feb. 29, 2000, p. A3.
+
+57 For example, the “beef, pork, soybean, wool/lamb, and mohair check-off programs
+generate over $200 million annually in assessments collected from producers or growers.”
+AMS website, available at [http://www.ams.usda.gov/lsg/mpb/lsrp.htm]. In 2003, AMS
+reported that the assessments for all promotion programs came to over $700 million.
+Agricultural Marketing Service, “AMS Commodity Research and Marketing Boards”
+(Washington: Apr. 28, 2004).
+
+58 Sharon Walsh, “Government Oversight? USDA Asks: The Promotion Programs Have
+Been Criticized for Inappropriate Spending,” Washington Post , Dec. 16, 1999, p. E1.
+
+59 See Department of Agriculture, Agricultural Marketing Service, “Guidelines for AMS
+Oversight of Commodity Research and Promotion Programs,” 65 Federal Register 5853,
+Feb. 7, 2000.
+
+ 
+ CRS-19
+
+Some of the agricultural advertising (check-off) programs have also faced court
+
+challenges. Small farmers providing “boutique” products have sued the Department
+of Agriculture, claiming the fees were “government compelled speech” — a violation
+of the First Amendment of the U.S. Constitution. In some of these cases, the
+plaintiffs have won.60
+
+Over the years, departments and agencies have found it useful and advantageous
+
+to ask Congress to create, or authorize a department to create, nonprofit organizations
+to perform functions that the department itself finds difficult to integrate into its
+regular policy and financial processes. This is true, for example, when a department
+or agency receives gifts of real property and monetary gifts. The National Park
+Foundation is the most prominent example of such an organization, but there are
+others, such as the National Fish and Wildlife Foundation.
+
+The Department of the Interior, and especially the National Park Service,
+
+received gifts of land and monies from time to time to promote the programs of the
+department. With respect to the National Park Service (NPS), a National Park Trust
+Fund was established by Congress in 1935 to receive and hold such gifts. In 1967,
+the Trust was superseded by the National Park Foundation (NPF), established
+pursuant to law (81 Stat. 656; 16 U.S.C. 19e-19n). The NPF is a congressionally
+chartered nonprofit corporation organized to accept and administer gifts given to the
+NPS. The board of the NPF has as its members the Secretary of the Interior, the
+Director of the NPS, ex-officio , and “no less than six private citizens appointed by the
+Secretary.” In recent years, the board has had more than 20 members. The term for
+private citizens on the board is six years. The Secretary of the Interior is chairman
+of the board and the Director of NPS is secretary to the board. The board elects a
+president of the foundation who serves at its pleasure. Membership on the board is
+not deemed to be an office of the United States. The NPF has perpetual succession.
+
+Funding for the NPF comes from private gifts. One of the main initial purposes
+
+of the foundation was to permit the NPS to have a means whereby it might receive
+gifts and invest these funds in something other than federal government securities.
+The foundation is not on-budget and its employees are not federal employees. In
+2005, the NPF provided over $29 million in cash and in-kind support to the National
+Park Service.61 
+
+The foundation is viewed as an adjunct activity of the department and NPS, and
+
+is controlled by these agencies. The appointment process to the board is the
+Secretary’s principal insurance that the NPF will adhere to the general policy
+framework of the department.
+
+60 E.g., Joseph S. Cochran v. Anne Veneman, Department of Agriculture Secretary (3rd Cir.
+03-2522, Feb. 24, 2004), Michigan Pork Producers Association, Inc. v. Veneman (348 F.
+3d 157 (6th Cir. 2003)), Livestock Marketing Association v. U.S. Department of Agriculture
+ (335 F.3d 711 (8th Cir. 2003)), and United States v. United Foods, Inc. (533 U.S. 405
+(2001)) In other instances, these programs have been found to be constitutional. See
+ Johanns, Secretary of Agriculture, et. al. v. Livestock Marketing Association (125 S. Ct.
+2055(2005))
+
+61 National Park Foundation, Annual Report — 2005 (Washington: NPF, 2006), pp. 2-3.
+
+ 
+ CRS-20
+
+Finally, the situation of the Securities and Exchange Commission (SEC) and its
+
+two adjunct organizations is worth noting. Congress established the Securities
+Investor Protection Corporation (SIPC) in 1970 (84 Stat. 1636) to assure that cash
+and securities held in brokerage firms are protected from loss caused by securities
+firms’ failures. The SIPC is a nonprofit corporation under the District of Columbia
+Nonprofit Act, which provides that it “shall not be an agency or establishment of the
+United States Government....” Of the seven-member board of directors, one is
+appointed by the Secretary of the Treasury from among the Department’s officers and
+employees; one is appointed by members of the Federal Reserve Board from among
+its officers and employees; five directors are appointed by the President subject to the
+advice and consent of the Senate. The President designates the chairman, who is also
+the corporation’s chief executive officer.
+
+Although the SIPC is a nonprofit corporation under the D.C. law, it is
+
+effectively a subsidiary of the SEC. The corporation’s bylaws are subject to the
+SEC’s adoption, amendment, or rejection. The hybrid nature of the SIPC is revealed
+by various legal characteristics. The SIPC is not under any of the general
+management laws, including the Government Corporation Control Act (31 U.S.C.
+9102). However, to the extent that the bylaws and rules of the SIPC are approved or
+disapproved by the SEC, they are subject to the Administrative Procedure Act (5
+U.S.C. 551 et seq.). The corporation also has borrowing authority and a line of credit
+from the Treasury.
+
+Congress, in 2002, established the Public Company Accounting Oversight
+
+Board (PCAOB) (116 Stat. 745) to oversee the audit of public companies that are
+subject to securities laws. The board is also a nonprofit corporation under the DC
+Nonprofit Corporation Act. Officers of the board are not officers of the United
+States. Yet the board is required, under supervision of the SEC, to “establish or
+adopt, or both, by rule, auditing, quality control, ethics, independence, and other
+standards relating to the preparation of audit reports by issuers.” The SEC appoints
+the five members of the full-time board, after consultation with the chairman of the
+Board of Governors of the Federal Reserve System and the Secretary of the Treasury.
+The Commission may remove members of the board “for good cause.” The rules of
+the board are subject to the approval of the Commission. Some observers were
+troubled that at the organizing meeting of this “private” board on January 9, 2003,
+the board voted themselves annual salaries of $452,000, or $52,000 more than the
+President of the United States and $207,000 more than the chairman of the SEC.
+Similar private sector salaries were set for staff.62
+
+The stories of the SIPC and the PCAOB illustrate how the government can
+
+create a hybrid organization, in these instances organizations with predominately
+private-sector legal characteristics, to implement government policies and
+regulations. Ultimately, the SPIC and the PCAOB are agents of and accountable to
+the government through the SEC. The wisdom (and for some the legality) of this
+practice of delegating governmental functions to ostensibly private parties is a
+legitimate subject of debate.
+
+62 Stephen Labaton, “Six Months Later, New Audit Board Holds First Talk: Sets Own Pay
+at $452,000,” New York Times , Jan. 10, 2003, p. 1.
+
+ 
+ CRS-21
+
+ Organizations Independent of, But Dependent Upon, Agencies. The
+
+Henry M. Jackson Foundation provides an example of an organization independent
+of, but dependent upon, an agency of the federal government. In 1982, Congress
+passed legislation to establish a Foundation for the Advancement of Military
+Medicine (P.L. 98-36; 97 Stat. 200). Five months later, the foundation was renamed
+the Henry M. Jackson Foundation after a Senator with a long record of support for
+military medicine. The enabling legislation provided that the foundation
+
+shall not for any purpose be an agency or instrumentality of the United States
+Government. The Foundation shall be subject to the provisions of this section
+and, to the extent not inconsistent with this section, the Corporations and
+Associations Act of the State of Maryland. 
+
+This language indicates there is intended to be legal distance between the nonprofit
+organization and the United States government.
+
+The mission of the foundation, by contrast, emphasizes that a close
+
+organizational relationship be established between the foundation and the Uniformed
+Services University of the Health Sciences (USU) of the Department of Health and
+Human Services. 
+
+It shall be the purpose of the Foundation (1) to carry out medical research and
+education research projects under cooperative agreements with the USU; (2) to
+serve as a focus for interchange between military and civilian medical personnel,
+and (3) to encourage the participation of the medical, dental, nursing, veterinary,
+and other biomedical sciences in the work of the Foundation for the mutual
+benefit of military and civilian medicine. (10 U.S.C. 178) 
+
+The nine-member board of the foundation includes two current Senators and two
+Representatives serving in an ex-officio capacity.
+
+The foundation works to develop a research infrastructure involving federal
+
+military medical personnel and private medical personnel and facilities. It is
+affiliated with the USU and receives funding from private sources as well as the
+USU. The foundation provides research and grants management services to military
+medical researchers; manages clinical trials and develops private-public partnerships;
+and provides general support for military medical education. In 2004, the foundation
+employed 1,400 persons and supported or administered over 650 research projects.63
+
+The question arises: why is such a foundation needed? The foundation has said:
+
+Because government employees cannot accept money or in-kind gifts from
+private sources, the Foundation serves a vital function by facilitating
+collaborative relationships between private industry, academia, and military
+
+63 Henry M. Jackson Foundation, HJF Overview Sheet, Dec. 2004, available at [http://www.
+hjf.org/about/factsheet12_04.pdf].
+
+ 
+ CRS-22
+
+medicine. One way we do this is securing private funding to support military
+medical educational programs....64 
+
+Similarly, the Department of Veterans Affairs (VA) has a network of nonprofit
+
+corporations attached to its medical centers. By law (P.L. 100-322; 102 Stat. 487),
+the Secretary may authorize the establishment at any VA medical center of a
+nonprofit research and education corporation (NPC), to be chartered under the
+resident state law, “to provide a flexible funding mechanism for the conduct of
+approved research.”65 The law reads: “Except as otherwise required in this
+subchapter or under regulations prescribed by the Secretary, any such corporation,
+and its directors and employees, shall be required to comply only with those Federal
+laws, regulations, and executive orders and directives which apply generally to
+private nonprofit corporations.” (38 U.S.C. 7361(a)).66
+
+As of 2004, the latest data available, 92 VA medical centers had received
+
+approval for the formation of nonprofit research corporations. Approximately 87
+NPCs exist and are located in 40 states.67 They derive their funds from both federal
+and non-federal sources. In 2004, “NPCs reported $186.8 million in revenues
+including interest income and other miscellaneous receipts.”68 
+ 
+
+The Secretary appoints the boards of all corporations, which must in each
+
+instance include the director of the medical center, the chief of staff and assistant
+chief of staff of the medical center, and such other public members as the bylaws of
+the corporation direct. Each of the corporations has an executive director appointed
+by the board of directors with the concurrence of the Chief Medical Director of the
+Department. The corporation may employ such employees as it considers necessary
+and fix their compensation. The corporations come under the jurisdiction of the
+Department’s Inspector General. The directors and employees of the corporation
+“shall be subject to Federal laws and regulations applicable to Federal employees
+with respect to conflicts of interest in the performance of official functions” (38
+U.S.C. 7366(c)(1)).
+
+6 4 H e n r y M . J a c k s o n F o u n d a t i o n w e b s i t e , a v a i l a b l e a t
+[http://hjf.org/about/privatesupporters.html].
+
+65 These entities have also been referred to as medical center research organizations.
+
+66 VA regulations for these entities may be found in VA Handbook 1200.17, VA Research
+and Education Corporations (Washington: VA, 2001), available at [http://www1.va.gov/
+vhapublications/ViewPublication.asp?pub_ID=371]; and VA Handbook 1400.2, VA
+Education Corporations authorized by Title 38 United States Code (U.S.C.) Sections 7361
+Through 73 (Washington: VA, 2001), available at [http://www.navref.org/about/mem_
+handbook_14002.htm].
+
+67 These data were drawn from National Association of Veterans’ Research and Education
+Foundations (NAVREF), 2004 VA-Affiliated Non-Profit Research and Education
+Corporations Annual Report (Bethesda, MD: NAVREF, 2005), p. 2, at
+[http://navref.org/library/word/Summary%20Annual%20Reports%202004.doc].
+
+68 Ibid., p. 4.
+
+ 
+ CRS-23
+
+The medical center research organizations concept is not without its critics.
+
+Some NPCs have been faulted for expending funds on items not directly related to
+research (such as gifts and entertainment) and have been cited as in need of improved
+“accountability and oversight related to the administration of funds.”69 However,
+GAO has also reported that NPCs, have enhanced VA research efforts. Funds 
+
+collected by these nonprofits have been used to renovate laboratory space,
+purchase equipment, maintain VA research libraries, and cover travel expenses
+to conferences. In turn, the research environment has been able to attract highly
+qualified physicians, who often provide patient care, as well.70 
+
+ Nonprofit Organizations Affiliated with Departments or Agencies. 
+
+There are also nonprofit organizations, chartered under state law, that voluntarily
+affiliate with a departmental or agency program. This option has recently been
+reflected in law and applied by the Department of the Interior. As discussed above,
+the National Park Foundation (NPF) is appropriately viewed as an “adjunct
+organization under the control of a department or agency,” in this case the National
+Park Service of the Department of the Interior. The NPF was authorized by the
+National Park Omnibus Management Act of 1998 (P.L. 105-391; 16 U.S.C. 19o) to
+encourage the creation of nonprofit organizations with state charters to “assist and
+promote [philanthropy] at the individual national park unit level.” The intent of this
+program is to create a large number (“the greatest number of national park units
+practicable”) of local fund-raising partner organizations (“Park Partners”), each tied
+to a specific national park or national park program. For purposes of this report, it
+is worth noting that these Park Partners are to be created by persons within a
+community under their own state laws. 
+
+It is intended that the Park Partners will voluntarily “affiliate” with the
+
+foundation. The law instructs the foundation to include in its program encouraging
+the creation of Park Partners:
+
+(1) a standard adaptable organizational design format to establish and sustain
+
+responsible management of a local nonprofit support organization for
+support of a national park unit;
+
+(2) standard and legally tenable bylaws and recommended money-handling
+
+procedures that can easily be adapted as applied to individual national park
+units; and 
+
+69 Statement of Michael Slachta, Jr., Assistant Inspector General for Auditing, in U.S.
+Congress, Subcommittee on Oversight and Investigation and Subcommittee on Health,
+House Committee on Veterans’ Affairs, VA Research and NonProfit VA Research and
+Education Corporations , 107th Cong., 2nd sess., May 16, 2002 (Washington, GPO, 2003),
+pp. 4-6, quote at p. 5.
+
+70 Testimony of Cynthia A. Bascetti, Director Healthcare — Veteran’s Health and Benefits
+Issues, U.S. General Accounting Office, Subcommittee on Oversight and Investigation,
+House Committee on Veterans’ Affairs, VA Research and NonProfit VA Research and
+Education Corporations , 107th Cong., 2nd sess., Sept. 19, 2002 (Washington, GPO, 2003),
+pp. 19-21.
+
+ 
+ CRS-24
+
+(3) a standard training curriculum to orient and expand the operating expertise
+
+of personnel employed by local nonprofit support organizations. (16
+U.S.C. 19o(d)).
+
+A number of Park Partner organizations, some in existence prior to the law, are
+
+operating today in support of specific parks such as Grand Teton, Glacier, and
+Sequoia. Since there are over 375 park properties within the system, the number of
+possible Park Partner nonprofit corporations is considerable. Although the clear
+intention of the legislation is that the local nonprofit corporations become affiliated
+with the Park Partner program of the foundation, the ultimate authority and
+accountability of the corporations remains with the local organization. The law
+provides: “An affiliation with the Foundation shall be established only at the
+discretion of the governing board of a nonprofit organization.” (16 U.S.C. 19o (f)(2))
+
+ Venture Capital Funds 
+
+Hybrid organizations assigned by Congress to the quasi government perform a
+
+wide variety of functions in both the domestic and international arenas. With respect
+to the latter, the case of “venture capital funds” is especially interesting, a term which
+encompasses more narrowly defined “enterprise funds” and “investment funds.”71
+
+The fall of Communism in eastern Europe and elsewhere in 1989 prompted
+
+interest by the United States, and especially Congress, in assisting those nations
+committed to a transition from a centrally planned to a market economy. The
+Support for Eastern European Democracy Act of 1990 (SEED) (P.L. 101-179; 22
+U.S.C. 5401) authorized the establishment of two “enterprise funds,” one in Poland
+and the other in Hungary. Later the legislation was amended to authorize the creation
+of enterprise funds in other eastern European countries, including the republics of the
+former Soviet Union, and the southern Africa region. By the end of 1995, there were
+11 such funds. 
+
+The impetus for the enterprise fund concept came about from the belief that a
+
+non-governmental entity was needed to implement this kind of program. The intent
+of Congress in SEED was to create venture capital funds that would be designed
+along private sector lines, managed by private sector executives, and be free of most
+government administrative constraints.
+
+The enterprise funds are chartered as private nonprofit corporations under the
+
+laws of the state of Delaware, but are funded by government appropriations. Their
+purpose is to develop the respective national private sectors through “loans, grants,
+equity investments, feasibility studies, technical assistance, training, insurance,
+guarantees and other measures.” Further, the act states that funding for the
+enterprises shall “be made available ... and used for the purposes of this section
+notwithstanding any other provision of law.” (22 U.S.C.A. 5421(a)(c)). The SEED
+
+71 A discussion of venture capital funds is to be found in: Jonathan G.S. Koppell, “The
+Challenge of Administration by Regulation: Preliminary Findings Regarding the U.S.
+Government Venture Capital Funds,” Journal of Public Administration Research and
+Theory , vol. 9, Oct. 1999, pp. 641-66.
+
+ 
+ CRS-25
+
+Coordinator in the Department of State and AID’s General Counsel and Inspector
+General interpreted this “notwithstanding” clause as exempting the funds from
+customary U.S. assistance program regulations.
+
+At the same time as the enterprise funds were being established, the Overseas
+
+Private Investment Corporation (OPIC), a wholly owned federal government
+corporation,72 was itself becoming involved in promoting private investments through
+“investment funds” established in the former communist states. OPIC’s principal
+mission is to provide political risk insurance and loan guarantees to U.S. corporations
+that make investments in selected developing countries. Although OPIC is
+prohibited from making direct equity investments, it may achieve approximately the
+same results by guaranteeing loans made to private, profit-seeking corporate
+investment funds. “OPIC-supported funds are among the largest providers of private
+equity capital to emerging markets. Since 1987, OPIC has committed (as of FY2005)
+over $2.6 billion in funding to 32 private equity funds.”73
+
+In the case of both the enterprise funds and OPIC’s investment funds, the intent
+
+was to have a pool of money to be assigned by a private management team to
+promising new or existing ventures. It is not the intent of this Report to evaluate the
+programmatic success or failure of these investment programs, that is best found
+elsewhere.74 Principal attention here is directed to some of the organizational
+characteristics of these venture capital funds and how they relate to the executive and
+legislative branches.
+
+With respect to enterprise funds, it was the intention of Congress that executive
+
+branch oversight of the funds be limited, a “hands off” policy. Initially, State
+Department and AID oversight of the enterprise funds consisted principally of an
+annual review by the AID IG, audits performed by certified public accounting firms
+selected by the enterprises, monthly reports on grant cash balances, semiannual
+reviews of the investment portfolios, and brief visits to both the U.S. and overseas
+fund offices. Various news accounts of alleged excesses and failures of the funds
+prompted both Congress and the executive branch, however, to subsequently
+strengthen the oversight of AID, although the funds still retain most of their
+autonomy.75 
+
+72 CRS Report 98-567E , The Overseas Private Investment Corporation: Background and
+Legislative Issues , by James K. Jackson. Eric Schmitt, “Development Agency’s Survival
+Tale: A Symbol of Corporate Welfare Becomes a Beacon of Enterprise,” New York Times,
+ Jan. 12, 2000, p. C2.
+
+73 OPIC website, available at [http://www.opic.gov/investment/index.asp].
+
+74 U.S. General Accounting Office, Enterprise Funds: Evolving Models for Private Sector
+Development in Central and Eastern Europe , GAO/NSIAD-94-77 (Washington: GAO,
+1994).
+
+75 Peter Maas, “Congressman Charges Aid Effort Goes Awry: Hungary Enterprise Fund
+Pays Fat Salaries,” Washington Post , July 29, 1993, p. A15; and Doug Bandow, Uncle Sam
+as Investment Broker , Cato Institute Policy Analysis No. 260 (Washington: CATO Institute,
+1996).
+
+ 
+ CRS-26
+
+Enterprise funds are chartered as nonprofit corporations under the laws of the
+
+state of Delaware and are governed by a board of directors “designated” by the
+President of the United States and elected by the existing board members. They are
+not “officers” of the United States and hence are not subject to Senate confirmation.
+The directors must be citizens of the United States or of the host country (or
+countries) and can be designated only after “consult(ing) with the leaders of each
+House of Congress.” (22 U.S.C. 5421(a)(1)). Although Congress and the existing
+directors have a role to play in the selection process, the reality is that this process
+has largely become a presidential prerogative and, according to critics, involves a
+certain amount of presidential patronage. Contractors are selected to manage the
+funds in the name of the boards. Thus, the determination of which firm ultimately
+receives the capital is made by third, and occasionally fourth, parties. In the latter
+instances, the enterprise fund establishes a subsidiary to make the final loan or grant
+determinations.
+
+The key element for protecting the government’s interests in the enterprise funds
+
+is to be found in the provisions agreed to in the loan or grant. Once in operation, it
+is difficult for AID to alter the course of the enterprise fund, although there remain
+several negative controls available, such as suspension of funds. In practice,
+however, such controls may be difficult to implement.76
+
+The OPIC investment funds are not in the business of directly providing capital
+
+themselves, rather they provide guarantees to private lenders who, in turn, lend
+money to recipients. OPIC is a government corporation enumerated in the
+Government Corporation Control Act and, as such, is a regular agency of the United
+States subject to the general management laws, except where exempted. It is
+governed by a 15-member board of directors, a number that includes in an ex officio
+ capacity various senior presidential appointees, as well as seven direct presidential
+appointees (22 U.S.C. 2193(b)). The board is chaired by the Administrator of AID.
+It is the President who appoints OPIC’s President, subject to Senate confirmation.
+
+Congress requires OPIC to undergo annual budgetary review, and the office is
+
+sometimes criticized on the basis that its insurance programs amount to a subsidy to
+some prosperous American corporations at taxpayers’ expense.77 OPIC has been
+able to keep relatively close oversight of its investment funds through its active role
+in selecting fund management and in negotiating terms of the loan guaranty
+agreements, terms that generally provide for favorable returns to OPIC. The
+objective of OPIC’s investment fund oversight is to insure compliance with the loan
+agreement, not necessarily to review or evaluate the fund’s investments in terms of
+good economic returns. Thus, compliance, rather than performance, is the primary
+focus of OPIC’s fund oversight. 
+
+In reviewing the comparative experience of enterprise and investment funds as
+
+part of a larger national venture capital promotion exercise, Koppell concludes that
+the federal government has the best opportunity to maintain a modicum of
+
+76 Koppell, “Managing the U.S. Government’s Venture Capital Portfolio,” p. 12.
+
+77 Leslie Wayne, “Spreading Global Risk to American Taxpayers,” New York Times , Sept.
+20, 1998, p. 1.
+
+ 
+ CRS-27
+
+accountability over these institutions through enforcement of regulatory practices,
+rather than attempting to run these quasi governmental bodies through direct
+administrative means. Koppel does not award the board of directors concept high
+marks as an effective method to promote accountability.78
+
+The issue of tenure is pertinent to venture capital funds. Are they intended to
+
+be permanent or temporary? Although Congress did not address this question
+directly with respect to enterprise funds, it was generally viewed that they would be
+a temporary arrangement. The length of time that each venture fund exists would
+depend on the specific country circumstances. For example, in September 2001, the
+Polish-American Enterprise Fund (PAEF) returned $120 million of its assets to the
+U.S. Treasury and transferred $180 million of its assets to the newly created Polish
+American Freedom Foundation — an entity which had previously received $80
+million from PAEF. The funds are to be used to provide grants to promote economic
+reform, leadership development among Polish citizens, a stronger civil society,
+improved local government, and more.79
+
+Venture capital funds are not exhausted by discussion of international enterprise
+
+and investment funds. In the past decade, venture capital funds have been established
+to fund research into technology. The first of these was “In-Q-Tel.” The announced
+purpose of In-Q-Tel is to permit the Central Intelligence Agency (CIA) to invest in,
+and thereby encourage, corporations producing technology the agency believes it will
+need to perform its mission in the future. Capitalized by $150 million in
+government funds, this nonprofit corporation is expected to be self-sufficient. On
+the board of directors are private corporate executives from firms such as Lockheed
+Martin. In the words of Gilman Louie, In-Q-Tel’s former CEO: 
+
+The best thing about In-Q-Tel, to me, is that it’s risky. The CIA and the rest of
+the government need to catch the entrepreneurial, risk-taking spirit that’s driving
+the Silicon Valley technology revolution. The CIA’s new venture may fall flat,
+but so what. Washington has been a zero-defect culture for too long. If we want
+a CIA that performs better, we’ll need to take more risks — and give our
+government freedom to fail.80
+
+In-Q-Tel is not the only domestic entity of this type. In January 2002, Congress
+
+authorized the Department of the Army to create a “non-profit venture capital
+corporation” (P.L. 107-117, sec. 8150). The Army subsequently established OnPoint
+Technologies.81 The National Aeronautics and Space Administration has hatched its
+own venture capital fund, Red Planet Capital. One of the organizers of this latter
+entity explained, “We will invest with others in companies making products that
+
+78 Koppell, “Managing the U.S. Government’s Venture Capital Portfolio,” pp. 25-34.
+
+79 U.S. White House Office, Office of the Press Secretary, “Fact Sheet: Polish American
+Freedom Foundation” (Washington: June 15, 2001), available at [http://www.whitehouse.
+gov/news/releases/2001/06/20010615-11.html].
+
+80 David Ignatius, “The CIA as Venture Capitalist,” Washington Post , Sept. 29, 1999, p. A1.
+
+81 See the website of OnPoint, available at [http://www.onpoint.us/]. 
+
+ 
+ CRS-28
+
+aren’t being made elsewhere and that NASA might be able to use.”82 Reportedly, the
+ultimate objective is to produce technologies that may be developed further by NASA
+and be used to explore Mars.
+
+Venture capital funds in which the federal government participates, either as the
+
+only party, or in cooperation with other parties, are often controversial. This is so
+because such funds require the government to participate in the private equity market
+and, in the eyes of some, to pick “winners.” Being a sovereign entity, the
+government cannot act as a private party seeking to maximize its fiduciary interests.
+
+ Congressionally Chartered Nonprofit Organizations 
+
+Within the quasi government, a category of entities can be collectively identified
+
+as “congressionally chartered nonprofit organizations,” also referred to popularly as
+“title 36 corporations.”83 The chartering by Congress of private organizations with
+a patriotic, charitable, historical, or educational purpose is essentially a 20th century
+practice. There are 92 organizations listed under Subtitle II, “Patriotic and National
+Organizations.”84 Typical among these chartered organizations is the Agricultural
+Hall of Fame; Big Brothers and Sisters of America; and the American Legion.
+
+Congress has authority to establish organizations within both the governmental
+
+and private sectors. In the governmental sector, the authority and responsibility to
+establish all agencies and all offices to be filled by appointed officers of the United
+States is clear. The actions of all agencies and officers of the United States are
+determined by public law. Congress also has authority to charter (establish) new
+private corporations, both for-profit and nonprofit. While Congress has exercised its
+prerogatives to charter for-profit corporations infrequently, there have nevertheless
+been several important instances, such as the establishment of the fully private,
+stockholder-owned Communications Satellite Corporation (ComSat) in 1962 (76
+Stat. 419; 47 U.S.C. 701). Much more frequently, Congress has chartered nonprofit
+organizations, either in the first instance, or as a rechartering of an existing state
+chartered nonprofit organization.
+
+Title 36 corporations can, and generally do, function simultaneously under both
+
+federal and state charters. Indeed, in most instances, organizations were chartered
+and functioned under state laws before, often long before, receiving federal charters.
+Congressional authority with respect to organizations functioning essentially under
+state law, however, has not been free of controversy. The basis of the controversy
+often comes down to fundamental issues of managerial accountability, fiduciary
+responsibility, and rights that inhere to governmental organizations, but not to private
+
+82 Marc Kaufman, “NASA Invests in Its Future With Venture Capital Firm,” Washington
+Post , Oct. 31, 2006, p. A19.
+
+83 CRS Report RL30340, Congressionally Chartered Nonprofit Organizations (“Title 36
+Corporations”): What They Are and How Congress Treats Them , by Kevin R. Kosar. 
+
+84 Title 36 of the U.S. Code, where congressionally chartered nonprofit corporations are
+listed with their charters, was recodified by law in 1998 (P.L. 105-225). 
+
+ 
+ CRS-29
+
+organizations, such as the right to the full faith and credit of the United States
+treasury.85
+
+In chartering patriotic, charitable and professional organizations under Subtitle
+
+II, such as the National Academy of Public Administration (36 U.S.C. 1501),
+Congress does not make these organizations “agencies of the United States,” nor does
+it confer any powers of a governmental character, or assign any benefits. These
+organizations do not receive direct appropriations, they exercise no federal powers,
+their debts are not covered by the full faith and credit of the United States, and they
+do not enjoy original jurisdiction in the federal courts.
+
+In effect, the federal chartering process is honorific in character. This honorific
+
+character may be misleading to the public, however, when such organizations feature
+statements or display logos that they are “chartered by Congress,” thus implying a
+direct relationship to the federal government that does not, in fact, exist. In addition,
+there may be an implication that Congress approves of the organizations and is
+somehow overseeing their activities, which is not the case.
+
+Recently, the non-agency character of Title 36 corporations may have been
+
+breached. The “privatization” of the Defense Department’s Civilian Marksmanship
+Program and its assignment to a newly created Title 36 corporation, the Corporation
+for the Promotion of Rifle Practice and Firearms Safety (36 U.S.C. 407), raises
+questions about the limits, if any, to Congress’ authority to assign a “private” label
+to functions of a governmental character.86 While the Corporation has some
+admittedly governmental attributes (e.g., upon the dissolution of the Corporation, its
+assets would be sold and the proceeds revert to the U.S. Treasury), Congress has
+declared in its enabling statute that “the corporation is a private corporation, not a
+department, agency, or instrumentality of the United States Government.”
+Furthermore, the law provides that “an officer or employee of the corporation is not
+an officer or employee of the Government.” Whether Congress has the constitutional
+authority to establish an entity “private,” when in fact it has “governmental”
+attributes, has been subject to debate and judicial opinion.87
+
+85 See discussion of the legal status of the earlier, now defunct, entry in the quasi
+government, the Federal Asset Disposition Association (FADA) established by the Federal
+Home Loan Bank Board in 1985 under the incorporation act of the state of Colorado in U.S.
+General Accounting Office, Failed Thrifts: No Compelling Evidence of a Need for the
+Federal Asset Disposition Association , FFO/FFD-89-26 (Washington: GAO, 1989); and
+U.S. Congress, Senate, Committee on Governmental Affairs, Managing the Public’s
+Business: Federal Government Corporations, by Ronald C. Moe, committee print 104-18,
+104th Cong., 1st sess. (Washington: GPO, 1995), pp. 22-26.
+
+86 The 2004 omnibus appropriation act (P.L. 108-447, Div. K, Sec. 146) declared that the
+National Veterans Business Development Corporation (NVBDC), thought by some to be a
+wholly government corporation, to be wholly private. On NVBDC as a government
+corporation, see Office of the Legal Counsel, United States Department of Justice,
+ Memorandum for Jennifer Newstead, General Counsel, Office of Management and Budget ,
+March 19, 2004. 
+
+87 The Supreme Court in a 1995 case ( Michael Lebron v. National Railway Passenger 
+
+(continued...)
+
+ 
+ CRS-30
+
+Private, nonprofit organizations seeking federal charters under Title 36
+
+presumably perceive value behind such charters, and indeed, such may be the case.
+Less apparent, however, are possible risks that might result from private, nonprofit
+organizations of having such a charter. A chartered private organization may lose
+some of its private rights and be made subject to management laws and regulations
+generally applicable only to agencies of the United States. Such a situation came
+about in 1997 when Congress amended the Federal Advisory Committee Act (5
+U.S.C. Appendix; 86 Stat. 700) so as to include two Title 36 corporations, the
+National Academy of Public Administration and the National Academy of Sciences,
+under specific provisions involving the appointment, permissible activities, and
+reports of corporation committees doing work for executive agencies. (P.L. 105-153)
+
+This is the first instance in which Congress has made Title 36, Subtitle II
+
+corporations subject to the provisions of a general management law, and, while the
+action may be supportable on public policy grounds, it does, to the extent of
+applicable provisions, diminish the private character of the affected organizations.
+As such, it constitutes a precedent with implications.
+
+Congress and the President have raised questions in the past about the
+
+consequences of granting charters to private organizations. In vetoing a corporate
+charter in 1965, the President raised several questions about the wisdom of
+continuing to grant charters on a case-by-case basis “without the benefit of clearly
+established criteria as to eligibility.”88 Congress, in 1969, responded to this
+presidential concern by setting out five “minimum standards” to be met by a private
+organization seeking a federal charter from Congress.89 These standards, however,
+did not resolve all of the questions concern the process of granting a charter, or of
+overseeing nonprofit organizations.
+
+87 (...continued)
+ Corporation; 513 U.S. 374) addressed the question of whether Congress can declare, by
+statutory language, that a corporation created by Congress and assigned attributes of the
+state, is a “private corporation.” The National Railway Passenger Corporation (AMTRAK),
+established by Congress (45 U.S.C. 451) and, at that time, enumerated as a “mixed-
+ownership corporation” under 31 U.S.C. 9101(2), was sued by Michael Lebron for rejecting
+on political grounds an advertising sign he had contracted with them to display. Lebron
+claimed that his First Amendment rights had been abridged by AMTRAK because it is a
+government corporation, and therefore an agency of the United States. AMTRAK argued,
+on the other hand, that its legislation provides that it “will not be an agency or establishment
+of the United States government” and thus is not subject to constitutional provisions
+governing freedom of speech. The Court decided that while Congress can determine
+AMTRAK’s governmental status for purposes within Congress’ control (e.g., whether it is
+subject to statutes such as the Administrative Procedure Act), Congress cannot make the
+final determination of AMTRAK’s status as a government entity for purposes of
+determining constitutional rights of citizens affected by its actions. 
+
+88 A copy of the veto message is printed as H. Doc. 292, 89th Cong., 1st sess. (Washington:
+GPO, 1965), p. 1.
+
+89 U.S. Congress, House, Committee on the Judiciary, Standards for Granting of Federal
+Charters to Non-Profit Corporations, committee print, 91st Cong., 1st sess. (Washington:
+GPO, 1969).
+
+ 
+ CRS-31
+
+At present, federal supervision of congressionally chartered nonprofit
+
+organizations is limited.90 All “private corporations established under federal law,”
+as defined and listed in Subtitle II, are required to have independent audits annually,
+and to have the reports of the audits submitted to Congress (36 U.S.C. 10101).91 In
+practice, the House Subcommittee on Immigration and Claims receives the audit
+reports of listed corporations, and, where corporations have not submitted reports in
+a timely manner, makes every effort to communicate with said organizations and
+remind them of their legal responsibility. The House Judiciary Committee refers all
+received audits to the Government Accountability Office for review.92 The
+committee’s current role is strictly ministerial. Public access to the records and
+reports of Title 36 corporations varies. For example, the charter of the National Ski
+Patrol (36 U.S.C 1527) requires that its annual report be submitted each year to
+Congress but forbids the public printing of it. The Senate Judiciary Committee has
+tended to defer to the House committee on these matters.
+
+It is not the intention of the Judiciary Committees of Congress or the General
+
+Accounting Office to “look over the shoulder” of these organizations, or to conduct
+audits on their own authority. Congress is understandably ambivalent with respect
+to chartered organizations; it attempts to protect the public interest against abuse by
+these corporate bodies while simultaneously seeking to limit its involvement in the
+internal affairs of these private organizations. Thus far, in no instance has the charter
+of a Title 36 organization been revoked or placed at serious risk through non-
+compliance with reporting requirements.
+
+Hearings held by subcommittees of the respective judiciary committees of the
+
+House and Senate in the early 1970s raised a number of questions by Members of
+Congress respecting the intent and practice of congressional chartering of private,
+nonprofit organizations. More organizations, through sympathetic members of
+Congress, were requesting charters, and the requesting organizations were often
+extending the definition of congressional chartered corporations beyond that typically
+associated with patriotic and service organizations.
+
+In April 1992, House Subcommittee on Immigration and Claims chairman
+
+Barney Frank announced that the subcommittee would no longer consider requests
+for charters. The reason, Frank reportedly said, was that the charters were “a
+
+90 With most generalizations concerning congressional chartered nonprofit organizations,
+there are exceptions. An exception to the general rule that Congress rarely becomes actively
+involved in overseeing these bodies is provided by the U.S. Olympic Committee (36 U.S.C.
+2205). Amy Shipley, “Senators Scold USOC Leaders: Congressional Oversight Urged as
+Part of Restructuring,” Washington Post , Jan. 29, 2003, p. D-1.
+
+91 Exceptions to this rule exist. The Corporation for the Promotion of Rifle Practice and
+Firearms Safety, created in 1996 by Congress, and not incorporated first in a state, is
+exempted (36 U.S.C. 40707) from the audit requirements otherwise applicable to Title 36
+corporations (36 U.S.C. 101).
+
+92 See, for instance, U.S. General Accounting Office, Federally Chartered Corporation:
+Review of the Financial Statement Audit Report for the United States Capitol Historical
+Society for Fiscal Year 1997 , B-280210, directed to the Chairman of the House Judiciary
+Committee, Henry Hyde, June 16, 1998.
+
+ 
+ CRS-32
+
+nuisance,” a meaningless act; granting charters implied that Congress was exercising
+some sort of supervision over the groups and it was not. “When I first raised the
+issue, ‘What is a federal charter?’ The answer was, a federal charter is a federal
+charter is a federal charter.... You could make up an organization for the preservation
+of Albert De Salvo, the Boston Strangler. We’d have no way of checking into it.”93
+
+Continuing to review applications on the basis of merit with the possibility of
+
+rejection, it was asserted, was subjecting the subcommittee to pressures and the
+potential for embarrassment to both the requester and Congress. By indicating an end
+altogether of the practice of chartering, it was hoped the subcommittee would be
+“leveling the playing field” among worthy organizations. This view was formalized
+in the 104th Congress when the subcommittee issued an internal policy directive that
+it would no longer consider any legislation to grant new federal charters because such
+charters were unnecessary for the operations of any charitable, nonprofit organization
+and falsely implied to the public that a chartered organization and its activities
+somehow enjoyed congressional approval.
+
+This subcommittee moratorium did not, however, stop all requests for, or
+
+consideration of, charter requests. Notably, it remains possible for another
+committee, or for the full Congress in its plenary capacity, to “charter” nonprofit
+organizations and have them listed in Title 36. This has happened in at least six
+instances in recent years. Nonetheless, in the 109th Congress, the Subcommittee on
+Immigration, Borders, and Claims reasserted the moratorium on March 10, 2005.94
+It remains to be seen, however, how effective this moratorium will be against the
+many attractions of the chartering practice.
+
+ Instrumentalities of Indeterminate Character 
+
+Not all the hybrid organizations fit into categories within the quasi government.
+
+Some organizations are sui generis while others partake of so many varied
+characteristics that they are best viewed and considered separately. Illustrative of
+quasi governmental entities are three examples that arguably merit discrete review.
+
+(1) American Institute in Taiwan 
+(2) National Endowment for Democracy
+(3) United States Investigation Services
+
+93 Bill McAllister, “Congressional Charters Abolished: Laws Recognizing Organizations
+Seen as Meaningless Nuisance,” Washington Post, Apr. 9, 1992, p. A25.
+
+94 U.S. Congress, Subcommittee on Immigration, Borders, and Claims, Subcommittee
+Organizational Meeting to Consider the Subcommittee’s Rules of Procedure for Private
+Immigration Bills, Rules of Procedure for Private Claims Bills, and Policy on Federal
+Charters for Private, Non-Profit Organizations , Mar. 10, 2005. Video of this committee
+meeting may be found at [http://boss.streamos.com/real/hjudiciary/immigration/immi0310.
+smi]. At the time of publication of this report, the Subcommittee on Citizenship, Refugees,
+Border Security, and International Law had not released its rules of procedure for the 110th
+Congress.
+
+ 
+ CRS-33
+
+ American Institute in Taiwan. In December 1978, President Jimmy Carter
+
+decided to establish full diplomatic relations with the People’s Republic of China,
+and did so effective January 1, 1979; the two countries exchanged ambassadors on
+March 1, 1979. As part of the arrangement, the President agreed to end the 1954
+mutual defense treaty with Taiwan and close the U.S. embassy in Taipei, the capital
+of the Republic of China (Taiwan).95 This decision was strongly objected to by a
+number of Senators, who maintained that treaties could not be terminated unilaterally
+by the President.96
+
+The Congress, presented with a presidential fait accompli, prepared legislation
+
+that would permit a continuing relationship with Taiwan (Republic of China) without
+the relationship being officially diplomatic in character.97 The decision was to
+establish a hybrid body that would provide a de facto rather than de jure
+representation. Congress enacted the Taiwan Relations Act (P.L. 96-8; 22U.S.C.
+3301), signed by the President on April 10, 1979, a key provision of which was the
+establishment of the American Institute in Taiwan (Institute) as a private, nonprofit
+corporation under the laws of the District of Columbia.
+
+The Institute, to be principally located in Taiwan, was nonetheless directed to
+
+maintain its headquarters in the United States. The officers and employees of the
+Institute are officers and employees of the United States who are “separated” from
+their agency during the specified period of employment within the Institute. As a
+practical matter, most employees are Foreign Service officers “separated” from the
+Department of States, who remain entitled to governmental benefits during the
+separation period. It was anticipated that Taiwan would establish a similar
+organization to the Institute, which it did.
+
+In subsequent years, political relations between the United States and the
+
+Peoples Republic of China have had their ups and downs, a situation with tangential
+impact on United States-Taiwan relations. These political strains have, to all
+appearances, not adversely impacted the functioning of the Institute. The Institute
+has generally provided an effective channel for government to government relations.
+Although the legal status of the Institute remains intentionally ambiguous, this has
+not yet resulted in any major public conflicts.
+
+ National Endowment for Democracy. In 1983, the Reagan Administration
+
+requested Congress to pass legislation for “Project Democracy” to promote and
+
+95 For a discussion of the political elements behind the President’s decision to recognize the
+People’s Republic of China (and the consequent withdrawal of recognition from the
+Republic of China), see “New Relationship with Taiwan Approved,” 1979 CQ Almanac
+ (Washington: CQ Press, 1980), pp. 99-117. 
+
+96 Louis Fisher, Constitutional Conflicts Between Congress and the President (Lawrence,
+KS: University Press of Kansas, 1997), pp. 242-45; and Susan Grayburn, “Goldwater v.
+Carter,” Brooklyn Journal of International Law, vol. 7, Winter 1998, pp. 111-33.
+
+97 For a discussion of recent relations between the United States and the Republic of China
+(Taiwan) generally, see Lester Wolff, Jon D. Holstine, and David J. Lewis, eds., A
+Legislative History of the Taiwan Relations Act , vol. 3, (New York: Pacific Community
+Institute, 1999).
+
+ 
+ CRS-34
+
+support the building of democratic institutions abroad, especially in countries newly
+emergent from totalitarian or dictatorial rule. Although the specific Administration
+proposal was not adopted, Congress did enact legislation that included approval for
+creating a National Endowment for Democracy (NED, or Endowment). The NED
+proposal was included in Title V of the State Department Authorization Act, FY1984
+and FY1985 (P.L. 98-164; 22 U.S.C. 4411).
+
+The National Endowment for Democracy Act reads: “The Congress finds that
+
+there has been established in the District of Columbia a private, nonprofit corporation
+known as the National Endowment for Democracy, which is not an agency or
+establishment of the United States.” (4411(a)). The purpose of NED is to encourage
+the development of free and democratic institutions throughout the world using the
+two major American political parties and labor and business organizations as the
+tools for promoting this policy.
+
+Although the law did not specify the creation of grantee organizations, it was
+
+generally understood at the time that four “core organizations” representing the two
+major political parties, American labor organizations, and American business
+organizations would be created as private, nonprofit organizations. The NED would
+not conduct democracy programs itself but would rely on core grantees. Grantees
+include the National Democratic Institute of International Affairs (NDI); the
+International Republican Institute (IRI); the American Center for International Labor
+Solidarity (ACILS);98 and the Center for International Private Enterprise (CIPE),
+which is affiliated with the U.S. Chamber of Commerce. 
+
+The rationale given for creating a hybrid status for the Endowment was that for
+
+NED to support democracy building programs, especially in inhospitable countries
+(countries where the U.S. is banned by law from providing direct foreign aid, such
+as the People’s Republic of China and Myanmar (Burma)), it must not be viewed as
+an arm of the U.S. government. Additionally, the core grantee organizations are one
+step further removed from the government, and thus provide a fourth-party
+administration of the infrastructure promotion system. The Endowment was
+envisioned principally as a conduit for funds to the grantee organizations, but has
+developed on its own a network for funding of other private organizations. 
+
+Under the by-laws of the organization as registered in the District of Columbia,
+
+NED has a board of officers and directors, which has ranged over time between 13
+and 30 members, the number being 30 in FY2007.99 The directors elect the president
+of NED and fill vacancies among their own number. The NED board is not subject
+to extensive government oversight and has retained the same individual, Carl
+Gershman, as president since the inception of the Endowment in 1983. The current
+chairman of the board of directors is Vin Weber, a former Member of Congress. 
+
+98 The American Council for International Labor Solidarity, an organization created in 1997,
+was the result of the merger of the Free Trade Union Institute and three other AFL-CIO
+regional labor institutes. CRS Report 96-222, National Endowment for Democracy: Policy
+and Funding Issues , by Susan Epstein.
+
+99 Website of the National Endowment for Democracy, available at
+[http://www.ned.org/about/who.html#board].
+
+ 
+ CRS-35
+
+Funding of NED is provided by an earmarked appropriation in the Commerce,
+
+Justice, State Appropriations Act whereby the Department of State awards these
+funds to NED. The total NED appropriation for FY2006 was $75 million (P.L. 109-
+108, Title IV; 119 Stat. 2325). 
+
+While the NED considers itself to be private, it must be managed under
+
+requirements of several general management laws. For instance, the Endowment
+must comply with the provisions of the Freedom of Information Act.100 Also, while
+the accounts of the Endowment are audited by independent firms, they are subject to
+review, and may be audited, by the Government Accountability Office.
+
+There has been debate in Congress over whether the United States government
+
+should be funding these types of organizations to “promote democracy.” The
+arguments pro and con necessarily impact NED as well as its core grantee
+organizations. From the perspective of the quasi government, NED is a classic
+example of a hybrid organization functioning under both private and public law.
+There is a range of opinion as to whether such a hybrid arrangement is necessary to
+achieve the results intended by the lawmakers.101 Furthermore, critics have accused
+NED of mission creep and asserted that NED has been associated with efforts to
+influence the outcomes of ostensibly democratic elections.102 
+
+ U.S. Investigation Services. As part of Vice President Gore’s
+
+“reinvention” program, a substantial downsizing of the civil service was ordered.103
+Agencies were expected to be “creative” in making sure the work continued to be
+done, but with less personnel and less funds. Cuts in the mission, capacity, funding,
+and personnel of the central management agencies (i.e., Office of Management and
+Budget; General Services Administration; and Office of Personnel Management)
+were particularly significant. At OPM, the security and investigations unit of the
+agency was a potential target for downsizing because its securities clearance
+workload was declining due to the end of the Cold War and because there were fewer
+new hires generally throughout the executive branch. 
+
+The Director of OPM, James King, created a first, the establishment by the
+
+government of a private corporation whose employees would be persons transferred
+from a federal agency, the Federal Investigations Division of OPM, to a private firm
+to be eventually owned by its employees in what is known as a Employee Stock-
+
+100 “Notwithstanding the fact that the Endowment is not an agency or establishment of the
+United States Government, the Endowment shall fully comply with all of the provisions of
+section 522 of Title 5.” (22 U.S.C. 4415(a))
+
+101 Despite being a not-for-profit chartered under the District of Columbia, NED is viewed
+by some as governmental. If this perception is widespread in other nations, then a major
+justification for NED’s status as a quasi governmental entity comes into question. NED,
+recall, was created as a quasi because it was not supposed to be viewed as an independent,
+nongovernmental entity.
+
+102 Juan Forero, “The Chavez Victory: A Blow to the Bush Administration,” New York
+Times , Aug. 20, 2004, p. 1; and Max Boot, “Exporting the Ukraine Miracle,” Washington
+Times , Jan. 3, 2005, p. A12.
+
+103 National Performance Review, Report , p. 14.
+
+ 
+ CRS-36
+
+Owned Plan (ESOP).104 The stated rationale was that it would save the jobs of the
+approximately 700 investigators who would no longer be needed and that it would
+save the federal government money by contracting with this new corporate body the
+investigations formerly performed in-house.
+
+Director King of OPM let a contract to ESOP Advisors, Inc. for a feasibility
+
+study of the concept, a study that reported that the privatization process culminating
+in an ESOP was feasible. King then announced his intention to move forward
+rapidly. Two hearings were held by congressional committees.105 The principal
+points argued by the opposition dealt with civil rights and privacy issues associated
+with private parties conducting and storing sensitive investigatory reports, and the
+propriety and legality of having government agencies creating privately owned
+corporations with special, financially advantageous relations, with the sponsoring
+agency. To the surprise of some, OPM, however, determined to move on its own
+initiative and without explicit statutory authority.106
+
+To launch the corporation, OPM choose American Capital Strategies (ACS) to
+
+develop a business plan. ACS selected Marine Midland Bank of New York as a
+financial trustee and together with Washington law firm, Arnold and Porter, began
+to recruit a management team. They selected, with King’s agreement, Philip Harper,
+a former security industry official, to take the first step, incorporating the company
+to be known as the US Investigation Service (USIS) under the laws of the state of
+Delaware in April 1996. The corporation at this point had a single share and a single
+employee — Harper.107
+
+The corporation was reincorporated in August 1996, at which time the 700
+
+former Office of Federal Investigations employees were separated from the
+government and became private employees. In April 1997, it was reported: 
+
+[The] 700 employee-shareholders own about 91 percent of a company valued at
+$28.2 million. Harper and the other 11 company officers, who together put up
+
+104 Stephen Barr, “OPM, In a First, Acts to Convert an Operation Into Private Firm,”
+ Washington Post, Apr. 14, 1996, p. A4.
+
+105 U.S. Congress, House, Committee on Government Reform and Oversight, Subcommittee
+on Civil Service, Oversight of Federal Investigations Policy, Hearings, 104th Cong., 1st sess.
+June 14, 1995 (Washington: GPO, 1995);——-. Outsourcing of OPM’s Investigations
+Program, Hearings, 104th Cong., 1st sess. June 15, 1995 (Washington: GPO, 1995).
+
+106 USIS’s official public website says: “On July 8, 1996, USIS was formed on the initiative
+of the President and Congress as an employee-owned company” (see [http://www.usis.
+com/history/history.html]). USIS, unlike ComSat or the American National Red Cross, has
+no congressional or federal charter. For its part, OPM told Congress that “[w]ith respect to
+contracting with an ESOP trustee to establish an ESOP corporation, we determined that no
+statute prohibited OPM from contracting for these services and that expending funds to enter
+into such a contract was a necessary expense pursuant to applicable fiscal law authority....
+Therefore, OPM’s decision to contract with an ESOP trustee does not require legislation.”
+ Outsourcing of OPM’s Investigations Program , Hearings, 1995, p. 54.
+
+107 Ronald P. Sanders and James Thompson, “Reinventing Government: Live Long and
+Prosper,” Government Executive , Apr. 1, 1997, pp. 51-53. 
+
+ 
+ CRS-37
+
+an initial seven-figure investment, hold the remaining shares. Under the terms
+of its corporate charter, USIS is governed by a nine-member board of directors.
+The board’s five “inside” members include Harper and two others elected by
+employees; the three of them in turn nominate the two remaining members.
+However, as with most private companies, the board’s role is limited. It does not
+run USIS — that’s Harper’s job, along with his immediate staff — instead
+concerning itself strictly with ‘ownership issues’ like oversight. For example,
+it ensures that company resources are allocated in the best interests of employee
+shareholders, and it also approves key strategic decisions. Of course, such issues
+are made easy when you begin a business with the federal government as a
+guaranteed customer.108 
+
+OPM then awarded USIS a noncompetitive three-year contract under a “public
+
+interest” exemption in federal contracting law.109 It was reported that the OPM
+employees would not have moved to the new private corporation without a
+guaranteed, sole-source contract providing a modicum of security. USIS has free
+access to government computer databases not otherwise available to the public or
+possible competing corporations. By any account, this government-sponsored,
+private corporation was given advantages and incentives not available to other private
+start-up corporations.110
+ 
+
+Critics of USIS and the privatization process followed in its creation tend to
+
+argue that background investigations are an inherently governmental function to be
+conducted by regular federal employees operating under all government management
+and security protection laws. They believe that legal accountability should be direct
+up through the agency, departmental and central management agency line to the
+President, and through the President to Congress. From their point of view, policy
+considerations, such as seeking to find jobs for otherwise underutilized or redundant
+employees, seeking lower unit costs, and the desirability of “profitability” for
+governmental activities, while of academic and political interest, are essentially not
+relevant as justifications for creating and supporting this hybrid organization. The
+critics argue that not all personnel investigations are alike and assert that the needs
+and requirements of the government (and indirectly of the public giving information
+to the government) are distinctive in legal terms from those applicable in the private
+sector. In their view, the issues are not economic in their fundamentals, but
+constitutional and legal. Moreover, the question arises: if OPM is free to transfer a
+portion of its workload and employees to the private sector, may other agencies do
+likewise?
+
+The Clinton Administration and supporters of OPM’s decision to “privatize”
+
+this activity, saw, on the other hand, in the USIS experience, a creative response to
+a changing situation regarding a government agency and its activities. This
+perspective views USIS as a successful exercise, one with lessons to be applied in
+
+108 Ibid.
+
+109 Stephen Barr, “OPM, In a First, Acts to Convert an Operation Into Private Firm,”
+ Washington Post, Apr. 14, 1996, p. A4. In 2001, USIS won the contract again with OPM
+in an open competition.
+
+110 Sanders and Thompson, “Reinventing Government,” p. 53.
+
+ 
+ CRS-38
+
+other situations. USIS’s moves into the private sector market, including extensive
+contracts with the casino industry, were seen as the logical progression of a generic
+activity: personnel investigations.
+
+The more recent activities of USIS have raised new questions as to the
+
+appropriateness of the privatization process and the mixing of the governmental and
+private sectors. Exactly which assets were transferred to the USIS in the first place
+is not clear, but whatever they were was deemed to be worth $28 million. The
+inadequacy of this figure became apparent as the Carlyle Group soon was able to
+purchase a substantial block of shares. Its purchase of shares in USIS appears to have
+been wise, timely, and fortuitous because the now private corporation underwent an
+incredible surge in business. In 1999 alone, the share value increased 702 percent.111
+
+In January 2003, venture capital firm, Welsh, Carson, Anderson, and Stowe,
+
+purchased the stock owned by original ESOP employees for a reported $545
+million.112
+
+This brief description of USIS, concludes this selective review of entities within
+
+the quasi government. Each category and entry has certain general characteristics
+worth noting as well as distinctive features. What is evident from this review is that
+certain basic philosophical issues are being debated, occasionally in direct terms but
+more often indirectly through the process of reorganization of the executive branch.
+This process is taking two forms: the reorganization of departments into agencies
+with agency-specific management laws,113 and the assignment of agencies and
+functions, both new and existing, to entities outside the executive branch, to the quasi
+government discussed in this report. This process has not been without its
+consequences for both the institutional presidency and Congress.
+
+ Conclusion: Paradigms in Conflict 
+
+Many observers believe that the underlying attraction of the quasi government
+
+organizational option can be traced to an innate desire of organizational leadership,
+both governmental and private sector, to seek maximum autonomy in matters of
+policy and operations.114 With respect to the governmental sector, however, this
+
+111 Website of USIS, available at [http://www.usis.com] (2003).
+
+112 Stephen Barr, “For Once-Federal Background Investigator, Privatization Leads to Its
+Own Kind of Check.” Washington Post, Apr. 24, 2003, p. B2.
+
+113 An example of the disaggregation of the management authorities in the executive branch
+is provided by the current exercise of excluding the Department of Defense, Department of
+Homeland Security, and other select agencies (e.g., Federal Aviation Administration) from
+most elements of Title V (Government Organization and Employees) of the U.S. Code. 
+
+114 “There is a persistent, universal drive in the executive establishment for freedom from
+managerial control and policy direction.... The desire for autonomy characterizes the
+operating administration and bureaus. As one observer has remarked, every agency wishes
+to be outside departmental structure or in the executive office of the President.... This
+
+(continued...)
+
+ 
+ CRS-39
+
+natural centrifugal thrust of organizational management has been historically held in
+check by a set of strong counter or centralizing forces. The constitutional paradigm
+(model) of management was, and remains, based on laws and accountability
+structures. The President is chief manager of the executive branch and manages
+through the appointment of officers, the administration of general management laws,
+and the budgetary process. The highest value in this public law model of
+management is political accountability for the exercise of governmental power.115 
+
+A unitary executive structure, coupled with hierarchical lines of authority and
+
+accountability, was a theoretical product of the founding fathers. The President was
+viewed as the chief manager of the administrative system. The governmental and
+private sector cooperated, but were kept legally distinct in the interests of protecting
+citizens’ rights against a potentially arbitrary government.116 Institutions not in the
+executive branch, but partaking of the attributes of governmental status were looked
+upon with suspicion as aberrations breaching the constitutional wall between the
+governmental and private sectors. These management values, however, were
+challenged in the 1960s by a new management theory (public choice theory)
+emanating from academia, and found expression in the election of political leaders,
+here and abroad, committed to market principles. The underlying premise of the
+entrepreneurial management paradigm is that the governmental and private sectors
+are essentially alike in the fundamentals, and thus subject to many of the same
+economically derived behavioral norms.117 The supporters of this position promoted
+their values and concepts of management internationally under the rubric of New
+Public Management (NPM) and domestically as part of the National Performance
+Review (NPR).118 
+
+Skeptics of the new entrepreneurial management paradigm say the centrality of
+
+public law is displaced by the centrality of economic axioms; the focus of
+management, once the citizen, is now the customer; and departmental integration as
+the norm is replaced by agency dispersion and managerial autonomy. They see
+political accountability and due process being superseded by the primacy of
+
+114 (...continued)
+desire for independence is an apparently innate characteristic of administrative behavior.”
+Herbert Emmerich, Federal Organization and Administrative Management (University, AL:
+University of Alabama Press, 1971), p. 17.
+
+115 Robert S. Gilmour and Laura S. Jensen, “Reinventing Government Accountability: Public
+Function, Privatization and the Meaning of ‘State Action,’” Public Administration Review ,
+vol. 58, May/June 1998, pp. 247-58.
+
+116 Ronald C. Moe and Robert S. Gilmour, “Rediscovering Principles of Public
+Administration: The Neglected Foundation of Public Law,” Public Administration Review ,
+vol. 55, Mar./Apr. 1995, pp. 135-46.
+
+117 Barry Bozeman, ed., Public Management: The State of the Art (San Francisco: Jossey-
+Bass, 1993); and Hugh Stretton and Lionel Orchard, Public Goods, Public Enterprise,
+Public Choice: Theoretical Foundations of the Contemporary Attack on Government (New
+York: St. Martin’s Press, 1994).
+
+118 U.S. Office of the Vice President, National Performance Review: From Red Tape to
+Results: Creating Government That Works Better and Costs Less (Washington: GPO, 1993).
+
+ 
+ CRS-40
+
+performance and results, however defined. Critics believe that the historic wall
+between the governmental and private sectors is being breached not merely as a
+managerial convenience, but as a matter of policy; so rather than a wall, government
+entrepreneurs are forging a web of public/private partnerships. 
+
+Given the great differences between the basic premises guiding the two schools
+
+of thought, those favoring traditional public law principles versus those favoring
+entrepreneurial approaches, it is not surprising that their attitudes towards the quasi
+government are also at odds. Those advocating entrepreneurial management tend to
+place high value on managerial flexibility and the setting of numerical performance
+standards. Many are opposed in principle to hierarchical leadership structures and
+emphasize the desirability of change and managerial risk-taking. This set of values
+with respect to governmental management makes the hybrid organization within the
+quasi government an attractive option.
+
+Those favoring the public law approach to management, on the other hand,
+
+argue that the purpose of government management is to implement the laws passed
+by Congress, not necessarily to maximize performance or to satisfy customers. 
+While accountability and effective performance are generally compatible objectives,
+in those unusual instances where these values come into conflict, they believe that
+the democratic value of political accountability should take precedence over the
+managerial value of maximizing efficiency and outcomes. Many of the public law
+advocates, not unexpectedly, tend to see quasi governmental entities as instruments
+of relatively small constituencies whose interests are promoted over the interests of
+the whole people as represented in their democratic institutions. Thus, they often
+oppose such quasi governmental hybrid entities as GSEs because they believe those
+who benefit (shareholders and management) are separate and apart from those who
+stand at risk (the taxpayers). 
+
+Supporters of performance based criteria for government management stress the
+
+need for flexibility, competition, and performance as desirable goals. The pre-
+eminence of these values, in their view, provides the critical elements in developing
+creative and successful management. In this respect, therefore, many believe that the
+quasi government is where much of the future lies, away from what they characterize
+as the stultifying impact of alleged micromanagement, both congressional and
+executive, general management laws (e.g., personnel regulations), and budgetary
+constraints. In the quasi government, some argue, management can do whatever is
+not forbidden to do by law, thus providing the basis for innovation and partnerships.
+Accountability will be for performance, however it may be defined and measured,
+rather than to strict conformance to law. In the new entrepreneurial management
+paradigm, success, proponents say, will be measured by polling the customers on
+their trust and satisfaction of the delivery of governmental services.
+
+Thus, the emergence and growth of the quasi government can be viewed as
+
+either a symptom of a decline in our democratic system of governance or as a
+harbinger of a new, creative management era where the principles of market behavior
+
+ 
+ CRS-41
+
+are harnessed for the general well-being of the nation.119 One thing is for sure,
+however: debate between the competing management paradigms is over important
+issues, such as the legitimacy and utility of the quasi government, and is likely to
+continue into the foreseeable future.
+
+ 
+
+119 Elaine Ciulla Kamark, “The End of Government As We Know It,” in John D. Donahue
+and Joseph S. Nye, Jr., eds., Market-Based Governance: Supply Side, Demand Side, Upside,
+and Downside (Washington: Brookings Institution, 2002), pp. 227-63; and Ronald C. Moe,
+“The Emerging Federal Quasi Government: Issues of Management and Accountability,”
+ Public Administration Review , vol. 61, May/June 2001, pp. 290-312.
\ No newline at end of file
diff --git a/corpus/politics/text/f17c991414287d5d.txt b/corpus/politics/text/f17c991414287d5d.txt
new file mode 100644
index 0000000000000000000000000000000000000000..89d865637a1eca0fb21e0c9a96194cc010859d15
--- /dev/null
+++ b/corpus/politics/text/f17c991414287d5d.txt
@@ -0,0 +1,340 @@
+Order Code RS20941
+
+Updated August 29, 2006
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ Air Force Aerial Refueling 
+
+Christopher Bolkcom
+
+Specialist in National Defense
+
+Foreign Affairs, Defense, and Trade Division
+
+ Summary 
+
+Aerial refueling aircraft are key to air operations. The U.S. tanker fleet is large and
+
+effective, but old. Modernizing or replacing the current fleet of tankers presents the
+Department of Defense (DOD) with difficult choices in terms of desired capabilities,
+force structure, and budget. How this fleet will be maintained or replaced, and on what
+schedule, has proven controversial. This report will be updated as events warrant.
+
+ Background 
+
+Modern military air operations require aerial refueling. Refueling aircraft, or tankers,
+
+extend the range of fighters, bombers, and other aircraft. Tankers increase the range and
+flexibility of projection forces. They increase the amount of time that combat and
+surveillance aircraft can stay “on-station,” and they boost combat aircraft lethality.
+According to senior Air Force officials, “Clearly the tanker fleet is really some of the
+very fiber that holds our Air Force’s unique global capabilities together. It is an essential
+enabler for getting to the fight and fighting the fight.”1 Navy aircraft can be configured
+to refuel other Navy or Marine Corps aircraft, but the Navy prefers to use “big wing” Air
+Force tankers for long-range flight operations.2
+
+Air Force and Department of Defense (DOD) leaders believe they need 550-650 KC-
+
+135-like aircraft.3 Yet the need for aerial refueling could grow in the future. Over the past
+several years, the United States has reduced by two-thirds the number of forward bases
+
+1 A. Butler, “Air Force Mulling Replacement for Aging, Maintenance-Needy KC-135,” Inside
+the Air Force , May 4, 2001.
+
+2 Department of the Navy (N78) provided to CRS by USN LLW via email Sept. 2, 2005.
+
+3 See, for example, Tanker Requirements Study-05. Department of the Air Force, Air Mobility
+Command. February 2001, and Mobility Capabilities Study (MCS). Office of the Secretary of
+Defense. December 2005. 
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ CRS-2
+
+from which it can operate. Major overseas en route air bases have declined 69%.4 Thus,
+to maintain the same level of engagement, U.S. forces must deploy more frequently and
+over greater distances. 
+
+ Air Force Capabilities. The majority of the Air Force’s tankers are Boeing KC- 
+
+ 135 Stratotankers . The Air Force owns 531 Stratotankers: 114 “E” models, and 417 more
+capable “R” models. The average KC-135 is approximately 45 years old. The KC-135 can
+carry 200,000 lbs of fuel that it dispenses to USAF aircraft through a flying boom. A
+drogue can be attached to refuel Navy, Marine Corps, or allied-country aircraft. The
+Multi-Point Refueling System Program outfits 20 KC-135Rs with wingtip pods so the
+aircraft can simultaneously refuel two probe-equipped aircraft. The KC-135 can also carry
+35,000 lbs of cargo in addition to its fuel payload. The Stratotanker is expected to fly until
+2040.
+
+The Air Force also owns 59 Boeing KC-10A Extenders . The KC-10 has an average
+
+fleet age of 21.5 years. The KC-10 is more flexible and more capable than the KC-135.
+It can carry twice as much fuel as the Stratotanker , (356,000 lbs) and can be refueled in
+the air to increase delivery range or on-station time. All KC-10s use the flying boom, and
+20 can employ wing tip probe and drogue systems. The KC-10 can carry up to 75 troops
+and 170,000 lbs of cargo in addition to its fuel payload, representing approximately 12%
+of all of DOD’s organic airlift capability. Current plans call for the KC-10 to remain in
+the active inventory through 2040.
+
+A brief review of recent conflicts underscores the importance of tanker aircraft. In
+
+both Iraq and Afghanistan, U.S. military aircraft projected power over long distances and
+in theaters with less than desirable access to forward bases or neighboring airspace. Thus,
+combat and support aircraft had to fly great distances both to the theater and while in
+theater, increasing aerial refueling demands. A large proportion of the Air Force’s aerial
+refueling fleet (149 KC-135s, and 33 KC-10s) participated in Operation Iraqi Freedom,
+flying over 6,000 sorties and offloading over 300 million pounds of fuel.
+
+ Modernization Controversy. Modernizing or replacing the Air Force tanker
+
+fleet has been a point of contention for 10 years. In 1996, the General Accounting Office
+(GAO) asserted that the long-term viability of the KC-135 fleet was questionable and
+advocated expeditiously studying replacement options. DOD countered that KC-135
+airframe hours were low and that the fleet was sustainable for another 35 years.5 In 2001,
+the Air Force reported that the KC-135 fleet would incur “significant cost increases”
+between 2001 and 2040, but “no economic crisis is on the horizon...there appears to be
+no run-away cost-growth,” and “the fleet is structurally viable to 2040.”6 At that time, the
+Air Force position on tanker modernization was to conduct an analysis of alternatives
+(AOA) to determine the optimal replacement option for KC-135s. Recapitalization would
+begin in the 2012 time frame to meet the KC-135 2040 retirement.
+
+4 Basic Air Force Structure and Expeditionary Aerospace Force (EAF) Operations , Maj. Gen.
+H. Chandler, Presentation to U.S. Air Force Caucus, Bolling AFB, Mar. 23, 2001.
+
+5 GAO/NSIAD-96-160.
+
+6 “KC-135 Economic Service Life Study,” Technical Report F34601-96-C-0111, Feb. 9, 2001.
+
+ 
+ CRS-3
+
+Section 8159 of the FY2002 DOD Appropriations Act (P.L. 107-117) authorized the
+
+Air Force to lease 100 Boeing KC-767 aircraft to replace the oldest KC-135Es. This
+proposal proved controversial because section 8159 appeared to depart from traditional
+acquisition processes and to weaken congressional oversight. It was also established that
+a lease would cost more than procuring the aircraft, and many found Air Force arguments
+in favor of the lease to contradict its position of just a year prior. The proposed lease was
+debated in four congressional hearings, culminating with a pair of Senate hearings in
+September 2003.7 Subsequently, alleged and admitted ethical violations by government
+and industry representatives involved in the lease proposal added to the controversy.
+
+The FY2004 Defense Authorization Act (P.L. 108-136, Sec. 135) forged a
+
+compromise between opponents and proponents of the KC-767 by giving the Air Force
+permission to lease 20 tanker aircraft and purchase no more than 80 aircraft. Section 134
+of this act prohibited the Air Force from retiring in FY2004 more than 12 KC-135Es. In
+September 2004, it was announced that the Air Force had grounded 29 KC-135Es due to
+safety concerns. Conferees also mandated that the Air Force conduct an aerial refueling
+AOA (Sec. 134) and that an independent assessment be conducted on the condition of the
+KC-135E fleet (Sec. 345).
+
+On February 1, 2004, former Deputy Secretary of Defense Paul Wolfowitz requested
+
+that the Defense Science Board (DSB) conduct the independent analysis of the KC-135E
+fleet, and on February 24, 2004, former acting Undersecretary of Defense for Acquisition
+Michael Wynne directed the Air Force to conduct an aerial refueling AOA. Although it
+had the statutory authority to proceed, DOD did not request any funds for FY2005 to lease
+20 aircraft or procure 80 aircraft. Defense Department leaders instead deferred executing
+either action until the completion of the DSB report, and an internal investigation by the
+DOD Inspector General (IG) on potential improprieties by Boeing Company executives
+and whether these activities negatively effected the Tanker lease program. 
+
+On April 20, 2004, Darleen A. Druyan, the former lead Air Force negotiator on the
+
+tanker lease program, pleaded guilty to one charge of criminal conspiracy. Ms. Druyan
+admitted to secretly negotiating an executive job with the Boeing company while still
+overseeing the $23 billion deal between the Air Force and Boeing.8 Lease supporters
+argued that Ms. Druyan was a single “bad apple” and that her actions did not negate the
+KC-767’s merits. In February 2005, however, it was reported that the DOD IG found that
+Air Force Secretary James Roche misused his office when he lobbied the Office of
+Management and Budget (OMB) to support the lease concept.9 The IG’s final report
+found that four other senior DOD officials were guilty of evading OMB and DOD
+acquisition regulations that are designed to demonstrate best business practices and to
+provide accountability. The DOD IG found that senior DOD officials knowingly
+misrepresented the state of the KC-135 fleet and aerial refueling requirements.10 
+
+7 See CRS Report RL32056, The Air Force KC-767 Tanker Lease Proposal 
+
+8 R. Merle, “Ex-Pentagon Official Admits Job Deal,” Washington Post, Apr. 21, 2004.
+
+9 R. Jeffrey Smith, “Roche Cited for 2 Ethics Violations,” Washington Post , Feb. 10, 2005.
+
+10 Management Accountability Review of the Boeing KC-767A Tanker Program , Office of the
+Inspector General of the Department of Defense, OIG-2004-171, May 13, 2005.
+
+ 
+ CRS-4
+
+ FY07 Congressional Action 
+
+As part of its FY07 budget request, the Air Force requested $240 million for KC-135
+
+replacement and expressed its plan to retire 78 KC-135Es. Both House and Senate
+authorizers rejected the Air Force request for $36.1 million in procurement funds. Senate
+authorizers cut $199 million from the $204 million requested in R&D funds, while the
+House cut $51 million from this request. House and Senate authorizers, (Sec. 135, 109-
+452 and Sec. 143, 109-254 respectively), agreed to allow the Air Force to retire only the
+29 KC-135Es grounded due to safety concerns. 
+
+ Issues for Congress 
+
+The FY2005 Defense Authorization Act (P.L. 108-375) contained a provision
+
+(Sec.133) that terminated the leasing authority granted by P.L. 108-136 (Sec. 135).
+Resurrecting the KC-767 lease, or initiating a similar lease, appears unlikely. As DOD
+considers new efforts to modernize or replace the Air Force aerial refueling fleet, several
+issues appear to compete for congressional attention.
+
+ 
+
+ Potential Tanker Options. There appear to be four general options for
+
+recapitalizing the aerial refueling capability of the KC-135E fleet: re-engine and
+modernize the current fleet, purchase one or more models of new commercial aircraft and
+convert them into a military tanker, purchase and convert used commercial aircraft into
+tankers, and lease aerial refueling services from the private sector. As part of its oversight
+function, Congress may wish to assess the strengths and weaknesses of each option and
+to assess whether implementing a single option or a mix of options is the most cost
+effective way to recapitalizing the aging KC-135 fleet.
+
+In May 2004, the Defense Science Board (DSB) published its independent
+
+assessment of the condition of the aerial refueling fleet. In addition to rebutting Air Force
+claims that the KC-135 fleet urgently needed to be replaced, the DSB recommended that
+“serious consideration be given” to purchasing and converting used aircraft for aerial
+refueling (especially the DC-10), re-engining some KC-135s, and increasing the use of
+commercial aerial refueling services. While others have also suggested these options (See
+CRS Report RL32056), the DSB is DOD’s most respected group of scientific and
+technical advisors, and its recommendations tend to be influential. 
+
+The DSB also noted that a tanker fleet consisting of two different types of aircraft
+
+ — large, long-range tankers and smaller, “tactical tankers” — is likely most prudent and
+effective. This recommendation may be gaining some traction within the Air Force. In
+August 2005, two important Air Force leaders (now both retired), Chief of Staff Gen.
+John Jumper and Air Mobility Command’s Chief Gen. John Handy, recommended
+acquiring more large tankers, like the KC-10.11 Larger tankers could potentially be based
+on aircraft such as the Boeing 777, the Airbus A330, or the C-17 airlifter. In the past, the
+Air Force has resisted suggestions to equally combine the airlift and refueling missions
+
+11 M. Selinger, “U.S. Air Force Needs More ‘KC-10-Like’ Tankers, General Says,” Aerospace
+Daily, Aug. 3, 2005. J. Bennett, “Jumper Forecasts Changes for USAF Aerial Refueling Tanker
+Fleet,” Inside the Air Force, Sept. 2, 2005.
+
+ 
+ CRS-5
+
+on a single large aircraft, but new budgetary constraints and the potential closing of the
+C-17 production line in January 2007 may increase the appeal of this concept.
+
+The congressionally-mandated analysis of alternatives (AoA) was completed in
+
+December 2005 and released to Congress in early 2006. This study found that purchasing
+new medium-to-large commercial aircraft and converting them into tankers was the most
+cost effective approach. Commercial aircraft in medium-to-large class include the Airbus
+330 and 340, and the Boeing 767, 787, 777 and 747. The AoA’s estimates of the cost-
+effectiveness of these aircraft are close enough that all can be considered as candidates,
+as could a mix of these aircraft. The AoA did not find cost-effective, the options
+recommended by the DSB: re-engining KC-135Es, converting used aircraft into tankers,
+and leasing commercial aerial refueling services.
+
+The AoA may be correct that purchasing approximately 500 new aircraft over the
+
+coming decades may be the most cost effective way to re-capitalize the KC-135 fleet.
+Purchasing 500 new aircraft also appears to be the most capital intensive option. To
+realize the maximum economic benefit, the Air Force will need, for many years, to invest
+a relatively large portion of its annual budget to purchasing tankers. The AoA notes that
+cost effectiveness estimates are highly sensitive to cost of the basic commercial aircraft
+prior to any military modification – also known as the “green aircraft.” Thus, other
+recapitalization options may be relatively more cost effective if green aircraft can’t be
+purchased for the desired price. Considering current emerging budget pressures, it may
+be useful to not prematurely decide against pursuing less capital intensive options such
+as re-engining some number of KC-135Es, purchasing used aircraft, and in some cases,
+leasing aerial refueling services.
+
+ Mobility Capabilities Study. The AoA for KC-135 Recapitalization was
+
+informed by, and produced in parallel with DoD’s Mobility Capabilities Study (MCS).
+The MCS is DoD’s first comprehensive mobility study since before the September 11th
+terrorist attacks. The MCS has been criticized on a number of grounds. Unlike past
+studies, the MCS did not provide a quantitative airlift requirement expressed in millions
+of ton-miles per day. Also, the MCS did not, according to some observers, adequately
+assess intra-theater airlift needs. The close linkage between the MCS and the AoA
+suggests that perceived shortcomings in one study apply to the other study. 
+
+ Industrial Base Concerns. Since 2001, discussions about replacing the KC-135
+
+fleet have featured debates over potential consequences for the U.S. aviation industrial
+base generally and the Boeing Co. specifically. Some claimed that the KC-767 lease was
+a financial “bailout” for Boeing, while others noted that U.S. aircraft manufacturers had
+suffered from reduced business after the September 11, 2001 terrorist attacks. Replacing
+KC-135s with American aircraft would have a dual benefit, they argued. The industrial
+base debate appears to have taken on increased focus beginning in the Spring of 2005.
+The European Aeronautic Defense & Space Co. (EADS) announced that it would build
+the Airbus A330 aircraft in a new factory in Mobile, AL rather than in Europe. Northrop
+Grumman Corp. announced that it would team with EADS to compete for future aerial
+refueling aircraft contracts. The KC-30, as the refueling aircraft would be named, would,
+
+ 
+ CRS-6
+
+according to Northrop officials, create 1,000 new American jobs and would be composed
+predominantly of American parts.12 
+
+Boeing supporters have complained that EADS receive direct government subsidies,
+
+making them unfairly competitive. In May 2005, the House Armed Services Committee
+published its version of the FY2006 Defense Authorization Act (H.R. 1815, H.Rept. 109-
+89), which some argue “levels the playing field” for the U.S. aircraft industry. Section
+817 would prohibit DOD from entering into a contract with any foreign company
+(including a joint venture) that received subsidies from a government in the World Trade
+Organization. This would appear to bar EADS from future tanker competition. 
+
+Supporters of limiting competition for future Air Force tanker contracts to U.S.
+
+companies argue that such action is warranted and vital to the health of the industrial base.
+Airbus, they note, was created in the early 1970s for the express purpose of maintaining
+and fostering the European commercial jet aircraft industry. Airbus’ growing
+international success, it is argued, is due to heavy and unfair subsidies from European
+governments, some of which violated the General Agreement on Tarriffs and Trade
+(GATT).13 European defense firms are increasingly successful in winning U.S. defense
+contracts, such as the VXX Presidential Helicopter, and the Army’s Light Utility
+Helicopter (LUH). These successes come at the expense of U.S. companies, and U.S.
+jobs, and make the United States dangerously dependent on foreign defense companies,
+it is argued. Further, the consolidation of the U.S. defense industrial base could reduce
+both domestic competition and innovation, ultimately resulting in less competitive and
+effective future products.
+
+Opponents of limiting competition for future Air Force tanker contracts to U.S.
+
+companies argue that such protection is unnecessary and potentially counterproductive.
+Such protections are unnecessary, it is argued, because DOD’s 2005 Annual Industrial
+Capabilities Report to Congress states that the U.S. defense industrial base is healthy and
+a world leader in 236 of 255 critical defense technologies.14 Further, the United States
+enjoys a foreign trade surplus in aerospace products, which is growing in 2005.15
+European companies have argued for years that U.S. companies like Boeing also receive
+indirect government subsidies, and this perspective was implicitly recognized by a 1992
+agreement on aircraft trade between the United States and the European Community.16
+Finally, some argue that increased European success in the U.S. defense market proves
+that this increases competition, which ultimately benefits U.S. civilian and military end-
+users, and more such “globalization” is to be promoted.17
+ 
+
+12 J. Karp, “Northrop, EADS Join on Air Force Proposal,” Wall Street Journal , Sept. 8, 2005.
+
+13 For more information, see CRS Report RS21002, Boeing/Airbus: Size, Speed, and Subsidies .
+
+14 Sharon Weinberger, “Annual Report Paints Rosy Picture of Defense Industrial Base,” Defense
+Daily , Mar. 28, 2005.
+
+15 “Aerospace Foreign Trade Surplus Growing,” Defense Daily, Sept. 6, 2005.
+
+16 RS21002 Opcit .
+
+17 Dave Ahearn, “Heritage Foundation Urges Further Defense Industry Globalization,” Defense
+Today, July 29, 2005.
\ No newline at end of file
diff --git a/corpus/politics/text/f2023caa59b87538.txt b/corpus/politics/text/f2023caa59b87538.txt
new file mode 100644
index 0000000000000000000000000000000000000000..ba631ff397a5b4e5be6b21838a5e7f65a7e4cf5c
--- /dev/null
+++ b/corpus/politics/text/f2023caa59b87538.txt
@@ -0,0 +1,1609 @@
+Order Code RL33359
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+ Oil Shale: History, Incentives, and Policy 
+
+ April 13, 2006 
+
+Anthony Andrews
+
+Specialist, Industrial Engineering and Infrastructure Policy
+
+Resources, Science, and Industry Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ Oil Shale: History, Incentives, and Policy
+
+ Summary 
+
+Oil shale is prevalent in the western states of Colorado, Utah, and Wyoming.
+
+The resource potential of these shales is estimated to be the equivalent of 1.8 trillion
+barrels of oil in place. Retorted oil shale yields liquid hydrocarbons in the range of
+middle-distillate fuels, such as jet and diesel fuel. However, because oil shales have
+not proved to be economically recoverable, they are considered a contingent resource
+and not true reserves. It remains to be demonstrated whether an economically
+significant oil volume can be extracted under existing operating conditions. In
+comparison, Saudi Arabia reportedly holds proved reserves of 267 billion barrels.
+
+Federal interest in oil shale dates back to the early 20th Century, when the Naval
+
+Petroleum and Oil Shale Reserves were set aside. Out of World War II concerns for
+a secure oil supply, a Bureau of Mines program began research into exploiting the
+resource. Commercial interest followed during the 1960s. After a second oil
+embargo in the 1970s, Congress created a synthetic fuels program to stimulate large-
+scale commercial development of oil shale and other unconventional resources. The
+federal program proved short-lived, and commercially backed oil shale projects
+ended in the early 1980s when oil prices began declining.
+
+The current high oil prices have revived the interest in oil shale. The Energy
+
+Policy Act of 2005 (EPACT) identified oil shale as a strategically important domestic
+resource, among others, that should be developed. EPACT also directed the
+Secretary of Defense to develop a separate strategy to use oil shale in meeting
+Department of Defense (DOD) requirements when doing so is in the national interest.
+Tapping unconventional resources, such as oil shale, has been promoted as a means
+of reducing dependence on foreign oil and improving national security.
+
+Opponents of federal subsidies for oil shale argue that the price and demand for
+
+crude oil should act as sufficient incentives to stimulate development. Projections
+of increased demand and peaking petroleum production in the coming decades tend
+to support the price-and-supply incentive argument in the long term.
+
+The failure of oil shale has been tied to the perennially lower price of crude oil,
+
+a much less risky conventional resource. Proponents of renewing commercial oil
+shale development might also weigh whether other factors detract from the resource’s
+potential. Refining industry profitability is overwhelmingly driven by light passenger
+vehicle demand for motor gasoline, and oil-shale distillate does not make ideal
+feedstock for gasoline production. Policies that discourage the wider use of middle-
+distillates as transportation fuels indirectly discourage oil shale development.
+Because the largest oil shale resources reside on federal lands, the federal
+government would have a direct interest and role in the development of this resource.
+
+This report will be updated as new developments occur.
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Geology and Production Technology of Oil Shale . . . . . . . . . . . . . . . . . . . . . . . . 3
+
+Kerogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Conventional Refining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
+Synthetic Fuel Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+Oil Shale Retorting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
+
+Shell In Situ Conversion Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+Oil Tech Above-Ground Retorting . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+History of Oil Shale Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+
+Early Synthetic Liquid Fuels Efforts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
+Defense Department Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+Department of Energy Synthetic Fuels Program . . . . . . . . . . . . . . . . . . . . . 10
+U.S. Synthetic Fuels Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
+Renewed Interest in Oil Shale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
+
+Incentives and Disincentives to Development . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
+
+The Cost of Constructing an Oil Shale Facility . . . . . . . . . . . . . . . . . . . . . . 15
+The Ideal Size for an Oil Shale Facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+Competing with Imported Distillates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
+Regulatory Disincentives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+
+Diesel Vehicle Demand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+CO, NOx, and PM Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+Ultra-Low Sulfur Diesel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
+Fuel Tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
+
+Policy Perspective and Consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
+
+Appendix: Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
+
+ List of Figures 
+
+Figure 1. Distribution of Oil Shale in the Green River Formation of Colorado, 
+
+Utah, and Wyoming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+Figure 2. Refiner Acquisition Cost of Imported Crude Oil . . . . . . . . . . . . . . . . 14
+Figure 3. Refinery Capacity Distribution Above and Below Median 80,000 
+
+BPD Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+
+Figure 4. Imported Crude Oil and Refined Products . . . . . . . . . . . . . . . . . . . . . 19
+Figure 5. Net Deliveries vs. Refinery Output of Gas/Diesel Oil for 
+
+OECD Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+
+Figure 6. Diesel vs Gasoline Fuel Tax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
+
+ List of Tables 
+
+Table 1. Properties of Oil-Shale Distillates Compared with Benchmark 
+
+Crude Oils . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+ 
+ Oil Shale: History, Incentives, and Policy
+
+ Introduction 
+
+Projections that peak petroleum production may occur in the coming decades,
+
+along with increasing global demand, underscore the United States’ dependence on
+imported petroleum. After Hurricanes Katrina and Rita, the spike in crude oil price
+and the temporary shutdown of some Gulf Coast refineries exacerbated that
+dependency. With imports making up 65% of the United States’ crude oil supply
+and the expectation that the percentage will rise, proponents of greater energy
+independence see the nations’s huge but undeveloped oil shale resources as a
+promising alternative.1
+
+Oil shales are prevalent throughout the United States. Their kerogen content
+
+is the geologic precursor to petroleum. The most promising oil shale resources occur
+in the Green River formation that underlies 16,000 square miles of northwestern
+Colorado, northeastern Utah, and southwestern Wyoming ( Figure 1 ). Approximately
+72% of the land overlying the Green River Formation is federally held.2 The
+formation is estimated to contain more than 8 trillion barrels of shale oil in place;
+however, much of the formation has been considered too thin, too deep, or too low
+in yield to economically develop using older technology. The former Office of
+Technology Assessment (OTA) estimated in 1980 that 1.8 trillion barrels appeared
+marginally attractive to production, based on deposits that would yield 15 gallons per
+ton and were at least 15 feet thick.3 In a more recent analysis, the portion of the
+formation yielding greater than 10 gallons per ton was estimated to contain 1.5
+trillion barrels.4 Because oil shales have not been proven economically recoverable,
+they are considered contingent resources and not true reserves.5 By comparison, the
+
+1 U.S. DOE Energy Information Administration (EIA), Monthly Energy Review January
+2006 , Table 1.7, Overview of U.S. Petroleum Trade, at [http://www.eia.doe.gov/
+emeu/mer/pdf/pages/sec1_15.pdf], visited Feb. 17, 2006.
+
+2 Thomas Lonnie, Bureau of Land Management, Testimony before the Senate Energy and
+Natural Resources Committee, Oversight Hearing on Oil Shale Development Effort, Apr.
+12, 2005.
+
+3 Office of Technology Assessment, An Assessment of Oil Shale Technologies , 1980, pp. 89-
+91, NTIS order #PB80-210115.
+
+4 James W. Bunger and Peter M. Crawford, “Is oil shale America’s answer to peak-oil
+challenge?” Oil & Gas Journal , Aug. 9, 2004.
+
+5 The Society of Petroleum Engineers defines true reserves as “those quantities of petroleum
+which are anticipated to be commercially recoverable from known accumulations from a
+given date forward.” See [http://www.spe.org/spe/jsp/basic/0,,1104_1575_1040460,
+00.html] (viewed Feb. 17, 2006).
+
+ 
+ 
+
+CRS-2
+
+conventional proved oil reserves of the United States are less than 22 billion barrels,
+and Saudi Arabia’s are reportedly 267 billion barrels.6
+
+ Figure 1. Distribution of Oil Shale in the Green River Formation of 
+
+ Colorado, Utah, and Wyoming 
+
+ Source: U.S. Geologic Survey, Circular 523 (1965), as reproduced by the U.S. Department of Energy
+in Strategic Significance of America’s Oil Shale Resources , Mar. 14, 2005.
+
+ Note: The Green River formation may contain more than 8 trillion barrels of shale oil in place, with
+an estimated 1.8 trillion barrels marginally attractive to production. The United States holds proved
+reserves of less than 22 billion barrels of conventional crude oil, compared with Saudi Arabia’s
+reported 267 billion barrels.
+
+In the early 20th century, three oil shale reserves were set aside on federal lands
+
+out of concern for the Navy’s petroleum supply. Naval Oil Shale Reserves (NOSRs)
+Nos. 1 (36,406 acres) and 3 (20,171 acres) are located 8 miles west of Rifle,
+Colorado, in Garfield County. Reserve No. 2 (88,890 acres) in Carbon and Uintah
+Counties, Utah, has been transferred to the Ute Indian Tribe. NOSR No.1 has been
+estimated to contain more than 18 billion barrels of shale oil in place.7 As much as
+
+6 U.S. DOE EIA, International Petroleum (Oil) Reserves and Resources , at
+[http://www.eia.doe.gov/emeu/international/oilreserves.html], visited Feb. 17, 2006.
+
+7 U.S. DOE, Naval Petroleum & Oil Shale Reserves, Annual Report of Operations Fiscal
+Year 1995 (DOE/FE-0342).
+
+ 
+ CRS-3
+
+2.5 billion barrels of oil may be recoverable from shale yielding 30 gallons of oil or
+more per ton. NOSR No. 3 is not considered to have commercial value.
+
+Oil shale production has faced unique technological and environmental
+
+challenges. The hydrocarbon resource is bound up in the shale and is not free to flow
+like petroleum. In previous attempts at production, conventional subsurface and strip
+mining methods were combined with high-temperature processing ( retorting ) to
+extract petroleum-like distillates. Not only was a plentiful water supply required, but
+certain processing methods had associated groundwater contamination issues. Unlike
+conventional petroleum production, wherein crude oil is shipped or piped to an
+established refining and distribution center, oil shale production would have required
+the vertical integration of resource extraction, processing, and upgrading to a finished
+product ready for blending and distribution. Recent interests in oil shale look to
+overcoming the past technical challenges associated with mining by adapting oil field
+production methods. Unlike conventional crude oil, oil-shale distillates make poor
+feedstock for gasoline production and thus may be better suited to making distillate-
+based fuels such as diesel and jet fuel. The cost of producing oil shale remains
+uncertain, especially when compared with the economic fundamentals of extracting
+conventional petroleum reserves.
+
+ Geology and Production Technology of Oil Shale 
+
+ Kerogen 
+
+The first phase in organic matter’s geologic transformation to petroleum is
+
+intermediate conversion to kerogen. During this low-temperature transformation —
+referred to as diagenesis — organically bound oxygen, nitrogen, and sulfur are
+released.8 Complete transformation to petroleum occurs during catagenesis — the
+prolonged exposure to temperatures in the range of 122° to 392°F, generally
+occurring at depths of 4,000 to 9,800 feet. The catalytic properties of the shale
+binding the kerogen contribute to the transformation. The threshold for intense oil
+generation begins at 149°F, equivalent to depths of 4,500 feet or more. Temperatures
+above 392°F mark the metamorphic end-state of transformation — ultimate
+conversion to methane gas and graphite (pure carbon).
+
+Oil shales have not thermally matured beyond the diagenesis stage due to their
+
+relatively shallow depth of burial. Some degree of maturation has taken place, but
+not enough to fully convert the kerogen to petroleum hydrocarbons. The Green River
+oil shale of Colorado has matured to the stage that heterocyclic (ring-like)
+hydrocarbons have formed and predominate, with up to 10% normal- and iso-
+paraffins (the range of hydrocarbons that includes natural gasoline).9 In comparison,
+conventional crude oil may contain as much as 40% natural gasoline. The kerogen’s
+rich hydrogen/carbon ratio (1.6) is a significant factor in terms of yielding high-
+
+8 John M. Hunt, Petroleum Geochemistry and Geology , W.H. Freeman and Co., 1979.
+
+9 C is shorthand notation for the number of carbon atoms. John M. Hunt, Petroleum 
+
+n
+
+ Geochemistry and Geology , W.H. Freeman and Co., 1979
+
+ 
+ CRS-4
+
+quality fuels. Its 1%-3% nitrogen content, however, may be problematic in terms of
+producing stable fuels (petroleum typically contains less than 0.5% nitrogen), as well
+as producing environmentally detrimental nitrogen oxides during combustion.10 To
+assess kerogen’s potential for yielding hydrocarbon-like fuels, the processes of
+conventional petroleum refining, synthetic fuel production, and oil shale retorting are
+compared below.
+
+ Conventional Refining 
+
+A conventional refinery distills crude oil into various fractions, according to
+
+boiling point range, before further processing.11 In order of their increasing boiling
+range and density, the distilled fractions are fuel gases, light and heavy straight-run
+naphtha (90°-380°F), kerosene (380°-520°F), gas-oil (520°-1,050°F), and residuum
+(1,050°F +). Gasoline’s molecular range is C -C ; middle-distillate fuels (kerosene,
+
+5
+
+10
+
+jet, and diesel) range C -C . Crude oil may contain 10%-40% gasoline, and early
+
+11
+
+18
+
+refineries directly distilled a straight-run gasoline (light naphtha) of low-octane
+rating.12 A hypothetical refinery may “crack” a barrel of crude oil into two-thirds
+gasoline and one-third distillate fuel (kerosene, jet, and diesel), depending on the
+refinery’s configuration, the slate of crude oils refined, and the seasonal product
+demands of the market.13
+
+Just as natural clay catalysts help transform kerogen to petroleum through
+
+catagenesis, metallic catalysts help transform complex hydrocarbons to lighter
+molecular chains in modern refining processes. The catalytic-cracking process
+developed during the World War II era enabled refineries to produce high-octane
+gasolines needed for the war effort. Hydrocracking , which entered commercial
+operation in 1958, improved on catalytic-cracking by adding hydrogen to convert
+residuum into high-quality motor gasoline and naphtha-based jet fuel. U.S. refineries
+rely heavily on hydroprocessing to convert low-value gas oils residuum to high-value
+transportation fuel demanded by the market. Middle-distillate range fuels (diesel and
+jet) can be blended from a variety of refinery processing streams.14 To blend jet fuel,
+refineries use desulfurized straight-run kerosene, kerosene boiling range
+hydrocarbons from a hydrocracking unit, and light coker gas-oil (cracked residuum).
+Diesel fuel can be blended from naphtha, kerosene, and light cracked-oils from coker
+
+10 Exxon Research and Engineering Co., Fundamental Synthetic Fuel Stability Study, First
+Annual Report for May 1, 1979 to April 30, 1981 .
+
+11 James H. Gary and Glenn E. Handwerk, Petroleum Refining, Technology and Economics
+ 4th ed., 2001. (Hereafter cited as Gary and Handwerk, Petroleum Refining: Technology and
+Economics .)
+
+12 Octane number refers to the gasoline property that reduces detrimental knocking in a
+spark-ignition engine. In early research, iso-octane (C -length branched hydrocarbon
+
+8
+
+molecules ) caused the least knock and was rated 100. Cetane number refers to a similar
+property for diesel fuel, for which normal hexadecane (C H ) is the standard molecule. 
+
+16
+
+34
+
+13 The term “crack spread” refers to the 3-2-1 ratio of crude-gasoline-distillate. The crack
+spread and the 3-2-1 crack is a hypothetical calculation used by the New York Mercantile
+Exchange for trading purposes. 
+
+14 Gary and Handwerk, Petroleum Refining: Technology and Economics .
+
+ 
+ CRS-5
+
+and fluid catalytic cracking units. From the standard 42-gallon barrel of crude oil,
+U.S. refineries may actually produce more than 44 gallons of refined products
+through the catalytic reaction with hydrogen.15
+
+From a simple crude distillation unit, a typical U.S. refinery has grown to a
+
+complex of 10 to 15 types of processes.16 The Nelson Complexity Index, a measure
+of a refinery’s complexity, assigns factors to the capacities of various processing
+units and compares them to the refinery’s crude distillation unit capacity. U.S.
+refineries rank highest in complexity index, averaging 9.5 compared with Europe’s
+at 6.5. The difference in complexity index reflects the 2-times greater catalytic
+cracking and 1½-times greater reformation capacities of U.S. refineries.17 Although
+U.S. refineries have optimized to produce reformulated gasoline, European refineries
+yield more middle-distillate diesel fuel to meet the greater European demand for that
+fuel.
+
+ Synthetic Fuel Production 
+
+Synthetic fuel technology was developed in prewar Germany to address its
+
+scarce petroleum resources. An early process developed by Friedrich Bergius used
+a catalyst to promote the reaction of hydrogen with coal liquids to produce low-
+quality gasoline. During the 1960s, the Department of the Interior’s Office of Coal
+Research sponsored research to directly liquefy Eastern coal into substitutes for
+natural gas and oil (synthetic liquid fuels).18
+
+In a competing process developed by German scientists Fischer and Tropsch,
+
+low-temperature catalysts were used to promote hydrogen’s reaction with coal gas
+and produce gasoline. The South African oil company Sasol later developed this
+technology further. Modern “gas-to-liquids” (GTL) technology based on the
+Fischer-Tropsch process converts natural gas to liquid fuels.
+
+Essentially, both the Bergius and Fisher-Tropsch synthetic fuel processes build
+
+up longer chain hydrocarbons from smaller molecules. This is the opposite of
+hydrocracking, the refining process that breaks heavier-weight molecular chains and
+rings into lighter-weight molecules using hydrogen and catalysts.
+
+15 Hydroprocessing describes all the processes that react hydrocarbons with hydrogen to
+synthesize high-value fuels. Hydrocracking reduces denser molecular weight hydrocarbons
+to lower boiling range products (predominantly gasoline). Impurities such as sulfur are
+removed by hydrotreating. Refineries produce the hydrogen needed for hydrotreating either
+by steam reformation of methane (liberated during the atmospheric distillation) or from a
+vendor who similarly converts natural gas (methane) to hydrogen. Alan G. Bridge
+“Hydrogen Processing,” Chapter 14.1, in Handbook of Petroleum Refining Processes , 2nd
+ed., McGraw-Hill, 1996.
+
+16 Robert E. Maples, Petroleum Refinery Process Economics , 2nd ed., Penwell Corp., 2000.
+
+17 Ibid., Table 4-1.
+
+18 Cohen, Linda R. and Roger G. Noll, “The Technology Pork Barrel,” Chapter 10, in
+ Synthetics from Coal , Washington, DC: The Brookings Institution, 1991.
+
+ 
+ CRS-6
+
+ Oil Shale Retorting 
+
+Oil derived from shale has been referred to as a synthetic crude oil and thus
+
+closely associated with synthetic fuel production. However, the process of retorting
+shale oil bears more similarities to conventional refining than to synthetic fuel
+processes. For the purpose of this report, the term oil-shale distillate is used to refer
+to middle-distillate range hydrocarbons produced by retorting oil shale. Two basic
+retorting processes were developed early on — aboveground retorting and
+underground, or in situ , retorting. The retort is typically a large cylindrical vessel, and
+early retorts were based on rotary kiln ovens used in cement manufacturing. In situ
+technology involves mining an underground chamber that functions as a retort. A
+number of design concepts were tested from the 1960s through the 1980s.
+
+Retorting essentially involves destructive distillation ( pyrolysis ) of oil shale in
+
+the absence of oxygen. Pyrolysis (temperatures above 900°F) thermally breaks
+down ( cracks ) the kerogen to release the hydrocarbons and then cracks the
+hydrocarbons into lower-weight hydrocarbon molecules. Conventional refining uses
+a similar thermal cracking process, termed coking , to break down high-molecular
+weight residuum.
+
+OTA compiled properties of oil-shale distillates produced by various retorting
+
+processes ( Table 1 ). In general, oil-shale distillates have a much higher
+concentration of high boiling-point compounds that would favor production of
+middle-distillates (such as diesel and jet fuels) rather than naphtha.19 Oil-shale
+distillates also had a higher content of olefins, oxygen, and nitrogen than crude oil,
+as well as higher pour points and viscosities. Above-ground retorting processes
+tended to yield a lower API gravity oil than the in situ processes (a 25° API gravity
+was the highest produced).20 Additional processing equivalent to hydrocracking
+would be required to convert oil-shale distillates to a lighter range hydrocarbon
+(gasoline). Removal of sulfur and nitrogen would, however, require hydrotreating.
+
+By comparison, a typical 35° API-gravity crude oil may be composed of up to
+
+50% of gasoline and middle-distillate range hydrocarbons. West Texas Intermediate
+crude (a benchmark crude for trade in the commodity futures market) has a 0.3%
+sulfur content, and Alaska North Slope crude has a 1.1% sulfur content.21 The New
+York Mercantile Exchange (NYMEX) specifications for light “sweet” crude limits
+sulfur content to 0.42% or less (A.S.T.M. Standard D-4294) and an API gravity
+between 37 and 42 degrees (A.S.T.M. Standard D-287).22
+
+19 OTA, Ch. 5 — Technology, p. 157.
+
+20 API gravity refers to the American Petroleum Institute measure of crude oil density — the
+higher the API gravity, the lighter the crude oil’s density. Light crudes exceed 38° API,
+intermediate crudes range 22° to 38° API, and heavy crudes fall below 22° API.
+
+21 Platt’s Oil Guide to Specifications , 1999 [http://www.emis.platts.com/thezone/guides/
+platts/oil/crudeoilspecs.html], viewed Apr. 5, 2006.
+
+22 New York Mercantile Exchange, Exchange Rulebook , Light “Sweet” Crude Oil Futures
+Contract, at [http://www.nymex.com/rule_main.aspx], visited Aug. 25, 2005.
+
+ 
+ CRS-7
+
+Oil-shale distillate has been considered a synthetic substitute for crude oil;
+
+however, its fungibility may be limited in modern refining operations. Because the
+ kerogen contained by the shale is only a petroleum precursor, it lacks the full range
+of hydrocarbons used by refineries in maximizing gasoline production. Also,
+because of technology limitations, only hydrocarbons in the range of middle-
+distillates (kerosene, jet fuel, diesel fuel) appear extractable.
+
+ Table 1. Properties of Oil-Shale Distillates Compared with 
+
+ Benchmark Crude Oils 
+
+ ° API 
+
+ % Sulfur 
+
+OTA Reported Oil-Shale Distillates Propertiesa
+
+19.4-28.4
+
+0.59-0.92
+
+Shell ICP Oil-Shale Distillateb
+
+34
+
+0.8
+
+Oil Tech Oil-Shale Distillatec
+
+30
+
+no report
+
+West Texas Intermediate Crude Oild 40
+
+0.30
+
+NYMEX Deliverable Grade Sweet Crude Oil
+Specificatione
+
+37-42
+
+<0.42
+
+Alaska North Slope Crude Oild
+
+29-29.5
+
+1.10
+
+a. OTA, An Assessment of Oil Shale Technologies , Table 19, 1980.
+b. Energy Washington Week, “Shell Successfully Tests Pilot of New In Situ Oil Shale Technology,”
+
+Oct. 12, 2005.
+
+c. Jack Savage, Testimony Before the Subcommittee on Energy and Mineral Resources, June 23,
+
+2005.
+
+d. Platt’s Oil Guide to Specifications , 1999.
+e. NYMEX, Exchange Rulebook , Light “Sweet” Crude Oil Futures Contract.
+
+Both in situ and above-ground retorting processes have been plagued with
+
+technical and environmental problems. Apart from the problem of sustaining
+controlled combustion underground, in situ retorting suffered from the environmental
+drawback of causing groundwater contamination. Above-ground retorting required
+underground or open-pit mining to excavate the shale first. While either mining
+method is well-practiced, the expended shale that remained after retorting presented
+a disposal problem, not to mention the overburden rock that had to be removed in the
+case of open-pit mining. Above-ground retorts also faced frequent problems from
+caked-up shale, which led them to shut down. Some recent approaches have aimed
+to avoid these drawbacks altogether.
+
+ Shell In Situ Conversion Process. For the past five years, the Shell
+
+Exploration and Production Company has been conducting research into directly
+extracting oil-shale distillates on its 20,000-acre Cathedral Bluffs property near
+Parachute (Rio Blanco County), Colorado.23 Unlike previously attempted in situ
+
+23 Testimony of Stephen Mut, Shell Unconventional Resources Energy Oil, Shale and Oil
+Sands Resources Hearing , Senate Energy and Natural Resources Committee, Tuesday, Apr.
+
+(continued...)
+
+ 
+ CRS-8
+
+retorting, Shell’s in situ conversion process (ICP) involves drilling holes up to 2,000
+feet deep, inserting electrical resistance heaters, and heating the shale to 650-700°F
+over a period of months. The ICP converts the kerogen to gas and petroleum-like
+liquids. The process not only consumes high amounts of energy to operate the
+heaters, it also requires freezing the perimeter of the production zone to restrict
+groundwater flow. Shell Oil Company reports extracting a 34°API product
+consisting of a gas (propane and butane) and b liquids split 30% naphtha, 30% jet
+fuel, 30% diesel, and 10% slightly heavier oil. Sulfur content was 0.8% by weight.
+
+ Oil Tech Above-Ground Retorting. Oil Tech, Inc., has been developing
+
+a new above-ground retort, which it reports as having the capacity of extracting one
+barrel of shale-oil per ton of shale per hour.24 The company has reported producing
+a low-sulfur 30° API-gravity oil consisting of 10% naphtha, 40% kerosene, 40%
+diesel, and 10% heavy residual oil. Starting off where past retorting attempts ended,
+Oil Tech intends to use previously mined oil shale that had been stockpiled.
+
+ History of Oil Shale Development 
+
+Oil shale was originally considered as a reserve supply of crude oil to fuel U.S.
+
+naval vessels in times of short supply or emergencies. Because the largest oil shale
+resources reside on federal lands, the federal government historically has had a direct
+interest and role in encouraging the development of this resource. Potential
+oil-bearing lands in California and Wyoming were first set aside for withdrawal as
+sources of fuel for the Navy under the Pickett Act of 1910. Later, presidential
+executive orders created NOSR Nos. 1 and 3 in Colorado and NOSR No. 2 in Utah.
+
+ Early Synthetic Liquid Fuels Efforts 
+
+During World War II, Congress’s concern for conserving and increasing the
+
+nation’s oil resources prompted passage of the Synthetic Liquid Fuels Act of 1944
+(30 U.S.C. Secs. 321 to 325), which authorized funds for the Interior Department’s
+Bureau of Mines to construct and operate demonstration plants to produce synthetic
+liquid fuel from oil shales, among other substances.
+
+Congress passed the Defense Production Act of 1950 (Ch. 932, 64 Stat. 798)
+
+during the Korean War to develop and maintain whatever military and economic
+strength was necessary to support collective action through the United Nations. The
+Title III program authorized governmental requisition of property for national defense
+and expansion of productive capacity, among other authorities. Between 1949 and
+1955, the U.S. Bureau of Mines received $18 million to operate three above-ground
+gas combustion retorts at Anvil Points, Colorado, the site of NOSR No. 1.
+
+23 (...continued)
+12, 2005.
+
+24 Jack S. Savage, Oil Tech, Inc., Testimony before the Hearing on The Vast North
+American Resource Potential of Oil Shale, Oil Sands, and Heavy Oils — Part 1 , House
+Subcommittee on Energy and Mineral Resources, June 23, 2005.
+
+ 
+ CRS-9
+
+Long before the United States’ increasing dependence on imported crude oil
+
+become apparent, oil shale began attracting the interest of some major petroleum
+companies: Exxon, Occidental Petroleum, and Union Oil, among others. In 1961,
+the Union Oil Company began testing its “Union A” retort at Parachute Creek,
+Colorado. Though producing 800 barrels per day (bpd), Union shut the retort down
+after 18 months due to cost. In 1964, The Oil Shale Company (Tosco), Standard Oil
+of Ohio (Sohio), and Cleveland Cliffs Mining formed a consortium to operate the
+Colony Oil Shale mine. Despite producing 270,000 barrels, Tosco shut down
+production in 1972. Occidental Petroleum also began oil shale retorting experiments
+in 1972 near Rifle, Colorado, and ultimately evaluated six retorts.
+
+ Defense Department Programs 
+
+The Defense Department had become interested in oil shale as an alternative
+
+resource for producing quality jet fuel as early as 1951.25 The U.S. Navy and the
+Naval Petroleum and Oil Shale Reserves Office (NPSRO) started large-scale
+evaluations of oil shale’s suitability for military fuels in the early 1970s. Tosco was
+contracted to produce and process 10,000 barrels of oil-shale distillates.
+Development Engineering, Inc., leased the federal Anvil Points site (Naval Oil Shale
+Reserve 3) in 1972 and formed the Paraho Development Corporation in 1973 (a
+consortium of 17 energy companies). Paraho’s plans included a five-year program
+to develop two pilot scale retorts and produce oil-shale distillates for the Navy fuel
+testing. Paraho initially produced 10,000 barrels of oil-shale distillates that Sohio
+processed into gasoline, JP-4 and JP-5 jet fuel, diesel fuel marine (DFM), and a
+heavy fuel oil at the Gary Western Refinery in Fruita, Colorado. Though the fuels
+produced were off-specification, analysis indicated that the refining process could
+be optimized to produce specification fuels. Paraho was awarded a follow-on
+contract to produce 100,000 barrels of oil-shale distillates for processing
+specification fuels in Sohio’s Toledo Refinery. The Navy conducted extensive tests
+with the fuels in military and commercial equipment.
+
+In the late 1970s, the Air Force became interested in evaluating oil shale’s
+
+suitability for producing JP-4 jet fuel. Under Project Rivet Shale, in 1979, the Air
+Force awarded contracts to Ashland Research and Development, Suntech, Inc., and
+UOP, Inc., to develop technology to produce oil shale-derived JP-4 jet fuel. In 1982,
+over 10,000 gallons of JP-4 were processed at the Caribou Four Corners Refinery in
+Woods Cross, Utah, from crude oil-shale distillates produced by Geokinetics. JP-4
+specification fuel was produced from other oil shale retorting techniques pioneered
+by Occidental, Paraho, and Union Oil. Unocal (formerly Union Oil Company)
+operated the Parachute Creek oil shale plant and reportedly produced 4.6 million
+barrels of oil-shale distillates from 1985 to 1990 for Air Force evaluation under
+Project Rivet Shale.26 The Air Force generally phased out JP-4 in the early 1990s in
+favor of kerosene-based JP-8.
+
+25 Personal communication with William E. Harrison III, Office of Deputy Under Secretary
+of Defense for Advanced Systems and Concepts, Oct. 25, 2005.
+
+26 The Center for Land Use Integration, Unocal Oil Shale Plant , at [http://ludb.clui.org/
+ex/i/CO3191/], visited Mar. 28, 2006.
+
+ 
+ CRS-10
+
+ Department of Energy Synthetic Fuels Program 
+
+The Department of Energy (DOE) encouraged interest in large-scale oil shale
+
+development through its Synthetic Fuels Program. DOE initially promoted two
+prototype lease tracts in the Piceance Basin of Rio Blanco County, Colorado (NOSR
+tracts C-a and C-b).27 Amoco later produced 1,900 barrels using in situ retorting in
+tract C-a, and Occidental Petroleum planned a similar effort for tract C-b.
+
+The Interior Department Appropriations Act (P.L. 96-126) and the Supplemental
+
+Appropriations Act of 1980 (P.L. 96-304) appropriated $17.522 billion to the Energy
+Security Reserve fund in the Treasury Department. Of that amount, $2.616 billion
+was committed by the Department of Energy to three synthetic fuels projects. Two
+of the projects were approved under the Defense Production Act: Union Oil
+Company’s Parachute Creek project in Garfield County, Colorado, and Exxon-
+Tosco’s Colony oil shale project, also in Garfield County. Union Oil Company
+received a $0.4 billion price guarantee for the Parachute Creek Shale Oil Project, and
+the Exxon-Tosco Colony Oil Shale Project received a loan guarantee of $1.15 billion
+(applied to the 40% owned by Tosco).28 Union Oil was expected to produce 10,400
+bpd at $42.50/bbl, which, adjusted for inflation, equaled $51.20/bbl by March 1,
+1985.
+
+As an additional stimulus to producing alternative fuels — for which oil shale,
+
+among others, qualified — Congress provided a $3.00 /bbl production tax credit
+provision in the Crude Oil Windfall Profit Tax Act of 1980 (P.L. 96-223). The credit
+would take full effect when crude oil prices fell below $23.50 /bbl (in 1979 dollars)
+and would gradually phase out as prices rose above to $29.50/bbl.
+
+Tosco’s interest in the Colony project was sold in 1979, and again in 1980, to
+
+Exxon Company for the Colony II development. Exxon planned to invest up to $5
+billion in a planned 47,000 bpd plant using a Tosco retort design. After spending
+more than $1 billion, Exxon announced on May 2, 1982, that it was closing the
+project and laying off 2,200 workers.
+
+ U.S. Synthetic Fuels Corporation 
+
+The Energy Security Act of 1980 (P.L. 96-294, Title I, Part B) established the
+
+United States Synthetic Fuels Corporation (SFC) with the authority to provide
+financial assistance to qualified projects that produced synthetic fuel from coal, oil
+shale, tar sands, and heavy oils. The SFC’s loan commitments would be paid from
+the Energy Security Reserve fund. Executive Order 12346 (Synthetic Fuels) later
+provided for an orderly transition of DOE’s earlier synthetic fuel program to the SFC.
+
+27 Garfield County, Colorado, Garfield County Comprehensive Plan Revision, Study Area
+Five , adopted version, Apr. 24, 2002, at [http://garfield-county.com/home/index.asp?page
+=664], visited Mar. 28, 2006.
+
+28 H.Rept. 99-196, Part 1, July 11, 1985.
+
+ 
+ CRS-11
+
+Between 1981 and 1984, the SFC received 34 proposals for oil shale projects
+
+in three rounds of solicitations. Only three letters of intent were ever issued. Union
+Oil’s Parachute Creek Phase II 80,000 bpd plant was to receive a $2.7 billion funding
+commitment and a guarantee of $60/bbl, escalated up to $67 /bbl; another $0.5
+billion in price and loan guarantees was added in October 1985 to Union’s Parachute
+Creek Phase I. Cathedral Bluffs, a 14,300 bpd plant based on a Union Oil design,
+was to receive a $2.19 billion loan guarantee and a $60/bbl price guarantee. Seep
+Ridge Oil Shale’s 1,000 bpd plant was to receive $45 million in price and loan
+guarantees. None of the oil shale projects that received SFC loan guarantees ever
+received actual funding, as Congress rescinded $2 billion originally appropriated for
+the Energy Security Reserve fund in the Deficit Reduction Act of 1984 (P.L. 98-369)
+and later abolished the SFC.
+
+In 1984, Congress asked the General Accounting Office (GAO) to report on the
+
+progress of synthetic fuels development and to specifically respond to the question
+“Why have project sponsors dropped synthetic fuels projects?” GAO answered that
+oil had become plentiful, with about 8 to 10 million barrels per day in excess
+worldwide capacity, and the trend in rising oil prices had reversed after early 1981.
+
+President Reagan’s Executive Order 12287 had removed price and allocation
+
+controls on crude oil and refined petroleum products in 1981. For the first time since
+the early 1970s, market forces replaced regulatory programs and domestic crude oil
+prices were allowed to rise to a market-clearing level. Decontrol also set the stage
+for the relaxation of export restrictions on refined petroleum products. Oil demand
+had also declined, due in part to energy conservation measures and a worldwide
+economic recession. A more fundamental change had taken place in the way that oil
+commodities were traded. Prior to 1980, the price of crude oil was determined by
+long-term contracts, with 10% or so of internationally traded oil exchanged on the
+spot market.29 By the end of 1982, more than half of the internationally traded oil
+was exchanged on the spot market or tied to the spot market price. The most
+significant change occurred in 1983, with the introduction of crude oil futures by the
+New York Mercantile Exchange (NYMEX). All served to undermine price setting
+by the Organization of Petroleum Exporting Countries (OPEC).
+
+Tax incentives for oil shale projects had also been reduced. Some of the
+
+generous oil depreciation allowances under the 1981 Economic Recovery Tax Act
+(P.L. 97-48) were rescinded in 1982 by the Tax Equity and Fiscal Responsibility Act
+(P.L. 97-248), reducing potential project sponsors’ after-tax rates of return.
+
+The House began considering a bill to abolish the SFC in 1985, and Congress
+
+terminated the Corporation the following year under the Consolidated Omnibus
+Budget Reconciliation Act of 1985 (P.L. 99-272). The Appendix to this report
+provides a more complete legislative history of the Synthetic Fuels program.
+
+29 Daniel Yergin, The Prize , Touchstone, 1991, pp. 722-725.
+
+ 
+ CRS-12
+
+ Renewed Interest in Oil Shale 
+
+In 2005, Congress conducted hearings on oil shale to discuss opportunities for
+
+advancing technology that would facilitate “environmentally friendly” development
+of oil shale and oil sands resources.30 The hearings also addressed legislative and
+administrative actions necessary to provide incentives for industry investment, as
+well as exploring concerns and experiences of other governments and organizations
+and the interests of industry. The Energy Policy Act of 2005 included provisions
+under Section 369 (Oil Shale, Tar Sands, and Other Strategic Unconventional
+Fuels31) that direct the Secretary of the Interior to begin leasing oil shale tracts on
+public lands and to cooperate with the Secretary of Defense in developing a program
+to commercially develop oil shale, among other strategic unconventional fuels.
+
+The Bureau of Land Management (BLM) established the Oil Shale Task Force
+
+in 2005 to address oil shale access on public lands and impediments to oil shale
+development on public lands. Title 30, Section 241(a) of the Mineral Lands Leasing
+Act formerly restricted leases to 5,120 acres. Advocates of oil shale development
+claimed that restrictions on lease size hindered economic development. The Energy
+Policy Act amended Section 241(a) by raising the lease size to 5,760 acres and
+restricting total lease holdings to no more than 50,000 acres in any one state.32
+
+On September 20, 2005, the Bureau of Land Management announced it had
+
+received 19 nominations for 160-acre parcels of public land to be leased in Colorado,
+Utah, and Wyoming for oil shale research, development, and demonstration
+(RD&D). On January 17, 2006, BLM announced that it accepted eight proposals
+from six companies to develop oil shale technologies; the companies selected were
+Chevron Shale Oil Co., EGL Resources Inc., ExxonMobil Corp., Oil-Tech
+Exploration LLC, and Shell Frontier Oil & Gas.33 Six of the proposals will look at
+in situ extraction to minimize surface disturbance. Each proposal will be evaluated
+under the National Environmental Policy Act (NEPA). In addition to the 160 acres
+allowed in the call for RD&D proposals, a contiguous area of 4,960 acres is reserved
+for the preferential right for each project sponsor to convert to a future commercial
+lease after additional BLM reviews.
+
+The Energy Policy Act also identified oil shale as a strategically important
+
+domestic resource and directed DOE to coordinate and accelerate its commercial
+development. Section 369(q) (Procurement of Unconventional Fuels by the
+
+30 The Senate Energy and Natural Resources Committee, Oversight Hearing on Oil Shale
+Development Effort , Apr. 12, 2005.
+
+31 Also cited as the Oil Shale, Tar Sands, and Other Strategic Unconventional Fuels Act of
+2005.
+
+32 30 USC 241 (4) “For the privilege of mining, extracting, and disposing of oil or other
+minerals covered by a lease under this section ... no one person, association, or corporation
+shall acquire or hold more than 50,000 acres of oil shale leases in any one State.”
+
+33 Bureau of Land Management, BLM Announces Results of Review of Oil Shale Research
+Nominations , Jan. 17, 2006, at [http://www.blm.gov/nhp/news/releases/pages/2006/
+pr060117_oilshale.htm], visited Mar. 29, 2006.
+
+ 
+ CRS-13
+
+Department of Defense) of the act directs the Secretaries of Defense and Energy to
+develop a strategy to use fuel produced from oil shale to help meet the fuel
+requirements of the Defense Department when the Defense Secretary determines that
+doing so is in the national interest. The Defense Department had worked jointly with
+Energy on a Clean Fuels Initiative to develop, test, certify, and use zero-sulfur jet
+fuels from alternative resources (oil shale, among others). By eliminating sulfur, the
+fuels would be suitable for use in fuel cells to generate electricity and in turbine
+engines used in aircraft and ground vehicles. A synthetic fuel process based on
+Fischer-Tropsch had been considered. At the time of the President’s FY2007 budget
+request, DOE proposed terminating oil technology research, and the Defense
+Department left Clean Fuels unfunded.34
+
+Since 1910, several legislation-based initiatives have attempted to promote oil
+
+shale development. (Legislation establishing the oil shale reserves and related federal
+programs is summarized in the Appendix of this report.) However, more recent
+regulatory policies (see below) appear adverse to oil shale development, at least to
+the wider use of middle-distillate fuels producible from oil shale.
+
+ Incentives and Disincentives to Development 
+
+The economic incentive for producing oil shale has long been tied to the price
+
+of crude oil. The highest price that crude oil ever reached — $87/bbl (2005 dollars)
+— occurred in January 1981 ( Figure 2 ).35 Exxon’s decision to cancel its Colony oil
+shale project came a year and half later, after prices began to decline and newly
+discovered, less-costly-to-produce reserves came online. The price of crude oil
+spiked to nearly $70/bbl after Hurricanes Katrina and Rita, and the recent climb to
+above $67 /bbl has led to some speculation that prices may remain high indefinitely.
+In the Energy Information Administration’s (EIA’s) reference case projection,
+though, “the average world crude oil price continues to rise through 2006 and then
+declines to $46.90/bbl in 2014 (2004 dollars) as new supplies enter the market. It
+then rises slowly to $54.08/bbl in 2025.”36 Near-record gasoline prices have led to
+similar speculation, as the average price of gasoline has stayed consistently above $2
+per gallon since May of 2005, and the on-highway diesel price has stayed even
+higher.37 However, oil company investment decisions may be more conservatively
+based on making profits at the $20-$30/barrel range of just a few years ago than on
+projected prices. That is, high prices may not be enough of an incentive for risky
+developments in conventional oil, let alone oil shale.
+
+34 Personal communication with Dr. Theodore K. Barna, Feb. 8, 2006.
+
+35 U.S. DOE EIA, Imported Crude Oil Prices: Nominal and Real , at
+[http://www.eia.doe.gov/emeu/steo/pub/fsheets/petroleumprices.xls], visited Apr. 5, 2006.
+
+36 U.S. DOE EIA, Annual Energy Outlook 2006 with Projections to 2030 (Early Release)
+ — Overview , December 2005, at[http://www.eia.doe.gov/oiaf/aeo/key.html], visited Apr.
+5, 2006.
+
+37 U.S. DOE EIA, Gasoline and Diesel Fuel Update , at [http://tonto.eia.doe.gov/oog/
+info/gdu/gasdiesel.asp], visited Apr. 5, 2006.
+
+ 
+ CRS-14
+
+ Figure 2. Refiner Acquisition Cost of Imported 
+
+ Crude Oil 
+
+ Source: U.S. DOE EIA, World Oil Market and Oil Price Chronologies 1970-2004 , Mar. 2005, at
+[http://www.eia.doe.gov/cabs/chron.html]; EIA Refiner Acquisition Cost of Crude Oil (for July 2005
+to Jan. 2006), at [http://tonto.eia.doe.gov/dnav/pet/pet_pri_rac2_dcu_nus_m.htm].
+
+Crude oil production costs vary widely by geography and reservoir conditions,
+
+and they may be more important factors now than 25 years ago as aging reservoirs
+decline in production. Production involves lifting the oil to the surface and the
+gathering, treating, and field processing and storage of the oil. The cost of
+production, sometimes referred to as lifting cost , includes labor to operate the wells
+and related equipment; repair and maintenance of the wells and equipment; and
+materials, supplies, and energy required to operate the wells and related equipment.
+In the Persian Gulf region, where a single well may produce thousands of barrels per
+day, production costs may be as little as a few dollars per barrel. Production costs
+in the United States had approached $15/bbl by 2004.38 ExxonMobile reported
+production costs increases from $4½ to $5½ /bbl for its U.S. operations over the past
+several years.39 In older, far less productive wells in the United States, production
+costs may reach more than $25/bbl.40
+
+In 1998, a supply glut forced the price of crude oil down to almost $10/barrel
+
+and gasoline sold for less than $0.80/gallon in some markets. Some domestic
+producers charged, in a U.S. Court of International Trade suit, that oil imports had
+
+38 U.S. DOE EIA, Performance Profiles of Major Energy Producers 2004 ,Table 11, Income
+Components and Financial Ratios in Oil and Natural Gas Production for FRS Companies,
+2003 and 2004, at [http://www.eia.doe.gov/emeu/perfpro/], visited Apr. 12, 2006.
+
+39 Exxon Mobile Corp, Form 10-K , Average sales prices and production costs per unit of
+production — consolidated subsidiaries Feb. 28, 2006.
+
+40 Thomas R. Stauffer, “Trends In Oil Production Costs In The Middle East, Elsewhere,”
+ Oil & Gas Journal , Mar. 21, 1994.
+
+ 
+ CRS-15
+
+been dumped on the American market.41 Though unsuccessful, the suit does say
+something further about bottom-line production costs (the crude oil price equivalent
+that producers could not compete below) and the production costs that oil shale may
+need to compete against. For several years preceding the price drop, crude oil ranged
+from $20 to $30/bbl.
+
+The perception that oil shale serves as a crude oil substitute overlooks the
+
+limited fungibility of the middle distillates that are extractable — they make poor
+feedstock for gasoline production. That does not necessarily prevent oil-shale
+distillates from being used as gasoline feedstock, but additional energy and hydrogen
+are needed to crack them. The loss may be even greater considering the lower fuel
+efficiency of spark-ignition engines that use gasoline, compared with compression
+ignition engines that use diesel distillate fuels.
+
+Other incentives or disincentives may include the cost and size of an oil shale
+
+processing facility, conventional refining profitability, and the cost and availability
+of refined commodities. Certain environmental and tax regulations that act as
+incentives to using gasoline in light-duty vehicles discourage middle-distillate diesel
+fuel use, and thus oil-shale distillates as substitute motor fuels.
+
+ The Cost of Constructing an Oil Shale Facility 
+
+A reliable cost estimate for producing oil shale has proved challenging, if not
+
+controversial. The cost of resources extraction had depended on whether
+conventional underground or strip-mining methods were employed. Because there
+was a considerable experience in mining, reliable cost estimates could be developed.
+A second variable — the cost of constructing and operating an oil shale facility —
+had to be accounted for separately. The former OTA estimated in 1979 that a 50,000
+bpd oil shale facility (based on above-ground retorting technology) would have
+required an investment of $1.5 billion and operating costs of $8 to $13/bbl. Using
+the Nelson-Farrar Cost Indexes to adjust refinery construction and operation costs to
+2004 dollars, the investment would be equivalent to $3.5 billion, with operating costs
+of $13 to $21/bbl.42 This excludes the cost of shale extraction.
+
+In comparison, the cost of building a new conventional refinery has been
+
+estimated to range between $2 and $4 billion as recently as 2001.43 The cost of
+operating a refinery (marketing, energy, and other costs) averaged nearly $6/bbl
+during 2003-2004, as reflected in the difference between gross and net margins
+(where the gross margin reflects the refiner’s revenue minus the cost of crude oil).44
+
+41 “U.S. Oil Dumping Case Wins Investigation By Commerce,” Oil & Gas Journal , Oct. 2,
+2000.
+
+42 1980 vs. 2004 Refinery Inflation Index and 1980 vs. 2004 Refinery Operating Index from
+the Nelson-Farrar Cost Indexes, Oil & Gas Journal (published first issue each month).
+
+43 “U.S. appears to have built last refinery,” Alexander’s Gas & Oil Connections , vol. 6,
+issue 13, Jul. 17, 2001.
+
+44 U.S. DOE EIA, Performance Profiles of Major Energy Producers 2004 , Table 15, U.S.
+
+(continued...)
+
+ 
+ CRS-16
+
+An oil shale facility may not be directly comparable to a refinery in terms of
+
+construction costs, though some processes, such as hydrotreating, may be common
+to both. If oil field-based technologies such as Shell’s proposed ICP are successfully
+adapted to resource extraction, facility costs could be reduced, but operating costs
+could increase given the energy-intensive aspect of the technology.
+
+Under the U.S. Air Force Project Rivet Shale, Union Oil’s Parachute Creek
+
+Phase I project produced 4.6 million barrels of oil-shale distillates from 1985 to 1990
+at a cost of $650 million; roughly the equivalent of $141/bbl, or $3.52/gal.
+(wholesale). Since Rivet Shale produced a jet fuel equivalent, a comparison might
+be made with the price of jet fuel at the time. In comparison, a refiner’s crude oil
+acquisition costs ranged from a less $15/bbl to $27/bbl in nominal dollars over that
+same time period.45 The spot market price for kerosene-based jet fuel rose from less
+than $0.40/gal in 1985 to more than $1.10/gal by 1990.
+
+The Rand Corporation recently estimated that a “first-of-kind” surface retort
+
+facility might cost $5-$7 billion, with operating costs of $17 to $23/bbl in 2005
+dollars. Rand projects that a crude oil equivalent of West Texas Intermediate would
+need to be at least $70 to $95/bbl for such an operation to be profitable.46 Shell Oil
+believes that in situ conversion can be profitable, producing oil-shale distillates at
+$25/bbl once steady-state production is reached.47 The disparity in estimates
+demonstrates the controversy over the issue. It should be noted that Rand refers to
+the older retorting technology that relied on mining methods for resource extraction,
+whereas Shell’s estimate is based on oil field-based technology for resource
+extraction.
+
+ The Ideal Size for an Oil Shale Facility 
+
+As domestic crude oil production declined through the 1970s, many marginally
+
+profitable and often smaller refineries were closed or idled.48 Of the 324 refineries
+operating 1981, 142 refineries currently remain operating. However, they represent
+a crude distillation capacity of approximately 17.5 million bpd, compared with 14.5
+million bpd in the mid 1980s, and range in size from 557,000 bpd (ExxonMobile’s
+Baytown, Texas refinery) to 1,707 bpd (Foreland Refining Corp’s refinery in Eagle
+
+44 (...continued)
+Refined Product Margins and Costs per Barrel Sold and Product Sales Volume for FRS
+Companies, 2003-2004, at [http://www.eia.doe.gov/emeu/perfpro/], visited Apr. 12, 2006.
+
+45 U.S. DOE EIA, Crude Oil Refiner Acquisitions Costs , Table 5.21, 1968-2004, at
+[http://www.eia.doe.gov/emeu/aer/txt/ptb0521.html], visited Feb. 21, 2006.
+
+46 Bartis, James, T., et al., Oil Shale Development in the United States , The Rand
+Corporation, 2005.
+
+47 “Is Oil Shale America’s Answer to Peak-Oil Challenge?” Oil & Gas Journal , Aug. 9,
+2004.
+
+48 The last new U.S. refinery was built in 1976 by Marathon Ashland in Garyville,
+Louisiana. U.S. DOE EIA, Country Analysis Briefs — United States of America January,
+2005 , at [http://www.eia.doe.gov/emeu/cabs/usa.html], visited Apr. 5, 2006.
+
+ 
+ CRS-17
+
+Springs, Nevada).49 The median capacity (half above and half below) of all operating
+refineries is approximately 80,000 bpd ( Figure 3 ). The 71 refineries above the
+median capacity are responsible for 85% of the current overall U.S. production (14.8
+million bpd). The trend toward larger refineries reflects the economic efficiency
+gained by increased scale. (For further information on refining, refer to CRS Report
+RL32248, Petroleum Refining: Economic Performance and Challenges for the
+Future , by Robert L. Pirog.)
+
+ Figure 3. Refinery Capacity Distribution Above and 
+
+ Below Median 80,000 BPD Size 
+
+ Source: EIA Annual Energy Outlook, Table 38, Capacity of Operable Petroleum Refineries by State,
+2005.
+
+OTA’s reference case 50,000 bpd oil shale facility would have been typical for
+
+refinery capacities in the late 1970s, but compared with current capacities, it might
+appear undersized. However, in terms of matching middle-distillate output, an oil
+shale facility requires a the capacity of a conventional refinery. Since U.S. refineries
+yield at most 47% motor gasoline vs. 33% middle-distillates, a 50,000 bpd oil shale
+facility today (producing middle distillates exclusively) would match the distillate
+output of a 150,000 bpd conventional refinery.50 This suggests that relatively smaller
+oil shale production facilities could be as effective as a larger conventional refinery
+when it comes to producing middle distillates.
+
+The complicated permitting process has been an argument against building a
+
+new refinery and for expanding an existing refinery’s capacity instead. The approval
+
+49 U.S. DOE EIA, Refinery Utilization and Capacity , at [http://tonto.eia.doe.gov/
+dnav/pet/pet_pnp_top.asp.], visited Feb. 22, 2006.
+
+50 U.S. DOE EIA, Petroleum Supply Annual 2004 , vol. 1, Table 19, Percent Refinery Yield
+of Petroleum Products by PAD and Refining Districts, 2004, at [http://www.eia.doe.gov/
+oil_gas/petroleum/data_publications/petroleum_supply_annual/psa_volume1/psa_volum
+e1.html], visited Apr. 5, 2006.
+
+ 
+ CRS-18
+
+process for new refinery construction has been estimated to require up to 800
+different permits.51 An oil shale facility’s considerably less complexity would appear
+to have an inherent advantage over a conventional refinery when it comes to
+permitting. Congress recognized that increasing petroleum refining capacity serves
+the national interest and included provisions in the Energy Policy Act of 2005 (Title
+III, Subtitle H — Refinery Revitalization) to streamline the environmental permitting
+process. A refiner can now submit a consolidated application for all permits required
+by the Environmental Protection Agency (EPA). To further speed the permit’s
+review, the EPA is authorized to coordinate with other federal agencies, enter into
+agreements with states on the conditions of the review process, and provide states
+with financial aid to hire expert assistance in reviewing the permits. Additional
+provisions under Title XVII (Incentives for Innovative Technologies) of the act
+guarantee loans for refineries that avoid, reduce, or sequester air pollutants and
+greenhouse gases if they employ new or significantly improved technology.
+Permitting would be a secondary consideration for new construction, if refining was
+an unfavorable investment.
+
+ Competing with Imported Distillates 
+
+Between 1993 and 2005, low-sulfur middle distillate production in the United
+
+States tripled from 328 million barrels to 1,058 million barrels, but some imports
+were still needed to satisfy demand ( Figure 4 ). The current 55 million barrels per
+year of imports is the equivalent of 150,000 bpd in production, or three oil shale
+plants on the scale of OTA’s reference case 50,000 bpd facility.
+
+51 “Crude Awakening,” Investor’s Business Daily , Mar. 28, 2005.
+
+ 
+ CRS-19
+
+ Figure 4. Imported Crude Oil and Refined Products 
+
+ Source: EIA Petroleum Navigator, U.S. Refinery Production of Distillates 15-500 ppm Sulfur, and
+U.S. Distillates 15-500 ppm Sulfur Imports, at [http://tonto.eia.doe.gov/dnav/pet/hist].
+
+Like U.S. refineries, European refineries also began to optimize for gasoline
+
+production in the early 1990s, only to see the European demand shift toward middle-
+distillate diesel fuel due largely to European tax incentives (discussed below) that
+favor diesel fuel use. Excess gasoline now produced by these refineries is exported
+to the U.S. market. Diesel fuel is forecast to make up 68% percent of European
+consumption by 2010.52 How European refineries respond to an increased diesel fuel
+demand will likely affect gasoline exports to the United States, particularly if the
+refineries shift their optimization more toward diesel than investing capital in
+additional diesel capacity. Both diesel and gasoline exports to the U.S. market could
+be reduced. U.S. refineries appear to have little excess capacity to make up both the
+gasoline and diesel loss, leaving some opportunity for oil shale to make up the
+distillate loss.
+
+Assuming that U.S. refineries yield a middle-distillates, actual refining capacity
+
+on the order of 1 million bpd would have been required. In terms of oil shale
+production, three 50,000-bpd plants processing 1,867 million tons of oil shale
+(yielding 15 to 30 gallons per ton) could be required to fill the possible gap in
+domestic supply.
+
+52 Energy Intelligence Group, “European Refiners Need to Bite Bullet of Downstream
+Investment,” Mar. 14, 2005, at [http://www.energyintel.com/].
+
+ 
+ CRS-20
+
+ Regulatory Disincentives 
+
+Apart from economic reasons, some regulatory policies may discourage the
+
+production and use of oil-shale distillate fuels. Both gasoline and diesel fuel are
+subject to Clean Air Act regulations and federal motor fuel taxes. Both regulations
+and taxes are more lenient towards gasoline use. In comparison, European Union
+(EU) environmental standards and tax regulations are more lenient towards diesel
+fuel and consequently have stimulated its broader consumption. Since oil-shale
+distillates could substitute for diesel fuel, any regulatory bias toward gasoline could
+act as a disincentive to oil shale production.
+
+ Diesel Vehicle Demand. Passenger vehicles and light-duty trucks (under
+
+8,500 lbs. gross vehicle weight) create the primary demand for transportation fuel in
+the United States. However, nearly 22% of the transportation fuel demand is for
+diesel, primarily in heavy-duty on- and off-road vehicles (semi-tractor trucks,
+earthmoving equipment, and railroad locomotives). Light-duty diesel trucks and
+passenger vehicles make up a smaller (but uncertain) percentage of the diesel
+demand, based on the lower number of miles private vehicles drive annually
+compared with commercial vehicles. Light-duty vehicles do, however, make up
+slightly more than half of the on-road diesel vehicles sold. Though overall, light-duty
+diesel vehicles have made up only 5% of the total light-duty vehicles sold recently
+(~349,000 light-duty diesel trucks and ~30,000 diesel passenger vehicles versus 16.9
+million total light-duty vehicles sold in 2004).53 The EIA sees a slower growth of
+light-duty diesel vehicles in the United States than in Europe.54 In contrast to U.S.
+sales of light-duty diesel vehicles, new diesel passenger vehicle registration in Europe
+rose from 22.3% in 1998 to 48.25% in 2004.55 The effect of increased diesel
+registration can be seen in the increased refinery output and net deliveries of diesel
+reported for European members of the Organization of Economic Co-operation and
+Development (OECD) by the International Energy Agency (IEA).56 (See Figure 5 .)
+
+Assuming that a separate diesel fuel for light-duty diesel vehicles will not be
+
+created, the EIA projects that U.S. refiners are unlikely to see the impact of a
+developing light-duty diesel vehicle market in the next decade. Given EIA’s
+projection, the opportunity for oil-shale distillates as diesel substitutes would appear
+similarly limited in the United States.
+
+53 Ward’s Automotive Yearbook 2005, U.S. Diesel Car Market Share , p. 36.
+
+54 U.S. DOE EIA, Can U.S. Supply Accommodate Shifts to Diesel-Fueled Light-Duty
+Vehicles? , Oct. 7, 2005.
+
+55 “The Changing Face of Europe’s Car Industry,” The Economist Newspaper Ltd , Mar. 24,
+2005.
+
+56 International Energy Agency, IEA Energy Statistics, Monthly Oil Survey , at
+[http://www.iea.org/Textbase/stats/oilresult.asp], visited Apr. 12, 2006.
+
+ 
+ CRS-21
+
+ Figure 5. Net Deliveries vs. Refinery Output of 
+
+ Gas/Diesel Oil for OECD Europe 
+
+ Source: International Energy Agency, Monthly Oil Survey , 2000 through 2005.
+
+ CO, NOx, and PM Emissions. Compared with spark-ignition (gasoline)
+
+engines, compression-ignition (diesel) engines characteristically emit lower amounts
+of carbon monoxide (CO) and carbon dioxide (CO ), but they emit higher amounts
+
+2
+
+of nitrogen oxides (NOx) and particulate matter (PM). NOx is the primary cause of
+ground-level ozone pollution (smog) and presents a greater problem, technically, to
+reduce in diesel engines than PM.
+
+The CO, NOx, and PM emissions for gasoline and diesel engines are regulated
+
+by the 1990 Clean Air Act amendments (42 U.S.C. 7401-7671q) Tier 1 and 2
+Emission Standards. Under Tier 1, the NOx standard had been 1.0 gram/mile for
+diesel passenger and light-duty trucks, versus 0.4 grams/mile for gasoline vehicles.
+The Tier 2 standards that started taking effect in 2004 are fuel-neutral. Regardless
+of the fuel, a fleet of vehicle models manufactured in a given year must average 0.07
+grams/mile for NOx emissions. A particular vehicle model may qualify in a unique
+emission “bin” (the maximum allowable is 0.2 grams/mile), as long as the fleet of
+models meets the average NOx emission standard. Other pollutants are similarly
+regulated.
+
+Since diesel engines inherently produce more NOx and PM than gasoline
+
+engines, producing more diesel vehicles raises the fleet emission average and thus
+limits the total number of vehicles a manufacturer can sell in the United States. This
+in turn limits the demand for diesel vehicles, which thus limits the opportunity for
+oil-shale distillates. The U.S. Tier 2 NOx emissions standards are more stringent
+
+ 
+ CRS-22
+
+than the EU’s current Euro 4 standards of 0.4 grams/mile for diesel cars and 0.6
+grams/mile for light-duty diesel trucks. Tier 2 PM-emission standards of 0.01 to 0.02
+grams/mile are also more stringent than Euro 4 PM-emissions of 0.04 grams/mile.
+
+ The Tier 2 CO-standard of 4.2 grams/mile is significantly less stringent than the
+
+Euro 4 standard of 0.8 grams/mile for diesel passenger cars and 1.2 grams/mile for
+light-duty diesel trucks. Tier 2 favors gasoline over diesel in this case.
+
+The EU is moving toward taxing cars on the basis of CO emissions (which
+
+2 
+
+favors diesel).57 This move is in response to the Kyoto Protocol on climate change,
+which seeks to limit CO emissions, a treaty that the United States signed but did not
+
+2 
+
+ratify.
+
+Should oil-shale distillates substitute for diesel, Tier 2 limits on CO, NOx, and
+
+PM emissions would continue to apply, as the standard is fuel-neutral. However, the
+emission characteristics of oil-shale distillates (similar to diesel) have not been the
+subject of documented research.
+
+ Ultra-Low Sulfur Diesel. By mid-2006, new U.S. standards for ultra-low
+
+sulfur diesel (ULSD) take effect under a 2001 rule issued by the EPA.58 Diesel fuel
+sulfur content must be reduced to no more than 15 parts-per-million (ppm) from the
+current 500 ppm (established by a 1993 rule that reduced the level from 5,000 ppm).
+However, to account for pipeline contamination, refiners may have to produce diesel
+fuel with a sulfur content as low as 7 ppm; a four-year phase-in period allows for
+20% of the highway diesel produced to meet the current limit.
+
+The EIA estimates the marginal cost of producing ultra-low sulfur diesel to
+
+range from 2.5¢ to 6.8¢ per gallon, depending on whether supply falls short of
+demand or consumers bid up the price.59 EIA projects the ULSD rule to require total
+refinery investments ranging from $6.3 to $9.3 billion. As the energy content of
+ULSD is somewhat less than 500 ppm diesel, fuel efficiency may be affected
+(increasing fuel consumption and therefore demand).
+
+The sulfur content of oil-shale distillates is comparable in weight percentage to
+
+crude oil ( Table 1 ). U.S. refiners were able to meet the current 500 ppm requirement
+by increasing the existing capacity of their hydrotreatment units and adding new
+units. However, refineries may face difficulty in treating diesel to below 500 ppm.
+The remaining sulfur is bound in non-hydrocarbon, multi-ring thiophene-type
+compounds that prove difficult to hydrotreat because the molecular ring structure
+attaches the sulfur on two sides. Although these compounds occur throughout the
+range of petroleum distillates, they are more concentrated toward the residuum end.
+
+57 “Emission Taxes Could Displace Registration Taxes,” The Economist Newspaper Ltd .,
+Mar. 24, 2005.
+
+58 U.S. EPA, “Control of Air Pollution from Motor Vehicles: Heavy-Duty Engine and
+Vehicle Standards and Highway Diesel Fuel Sulfur Control Requirements: Final Rule,”
+ Federal Register , 40 CFR, Parts 69, 80, and 86.
+
+59 U.S. DOE EIA, The Transition to Ultra-Low-Sulfur Diesel Fuel: Effects on Prices and
+Supply , May 2001.
+
+ 
+ CRS-23
+
+So, the problem is compounded when residuum is cracked to increase gasoline
+production. Improved hydrotreatment technology since the 1980s has increased
+sulfur removal and provided a means to removing oil-shale distillate’s excessive
+nitrogen content (desirable in terms of producing stable fuels with low NOx
+emissions).
+
+Whereas conventional refineries may be able to further upgrade hydrotreatment
+
+capacity by retrofitting, an oil shale processing plant would be designed and built
+from the ground up with necessary capacity. However, many refineries either
+produce the hydrogen needed for hydrotreating or purchase it from vendors that
+operate near established refining centers. An oil shale facility may require the
+addition of a steam reforming process to convert natural gas to the hydrogen needed.
+
+Refiners’ response to the ULSD rule ultimately affects diesel supply and thus
+
+price. As increased diesel fuel prices are likely to erode the lower operating-cost
+advantage of diesel engines over gasoline, the incentive for purchasing light-duty
+diesel vehicles would be less, in keeping with EIA’s projection of a slow growth in
+light-duty diesel vehicles over the next decade. On the other hand, a decline in diesel
+demand would offer even less incentive to produce oil-shale distillates for light-duty
+vehicles.
+
+ Fuel Tax. The U.S. federal tax rate on motor fuel currently favors gasoline
+
+over diesel fuel by 6¢ per gallon (18.4¢ and 24.4¢, respectively).60 Both gasoline and
+diesel tax rates began increasing after the mid-1980s, but diesel increased at a faster
+rate ( Figure 5 ). The higher diesel fuel tax is essentially a user fee paid by heavy-duty
+trucks to offset the higher road damage they cause than lighter duty vehicles. Where
+motor fuel taxes are applied to transportation infrastructure improvements in the
+United States, they are a source of general revenue for the 15 EU member states.
+
+60 U.S. DOT, “Federal Tax Rates on Motor Fuels and Lubricating Oil,” Table Fe-101a., at
+[http://www.fhwa.dot.gov/policy/ohim/hs03/htm/fe101a.htm]. The effective tax rate on
+gasoline and diesel terminated Oct.1, 2005; new rates have not yet been published.
+
+ 
+ CRS-24
+
+ Figure 6. Diesel vs Gasoline Fuel Tax 
+
+llon
+a
+ G
+
+ per
+
+ents
+C
+
+ Source: U.S. DOT, “Federal Tax Rates on Motor Fuels and Lubricating Oil,” Table Fe-101a.
+
+ Note: The U.S. federal tax rate on motor fuel currently favors gasoline over diesel fuel by 6¢ per
+gallon. European Union states (except UK) tax diesel fuel on average (62¢/gallon less than gasoline).
+
+Overall, motor fuel taxes are significantly higher in the EU, ranging from the
+
+equivalent of $3.28/gallon ( 742/1,000 liters at an exchange rate of $1.17: 1) for
+diesel and gas in the United Kingdom, to as low as 253/1,000 liters) ($1.12/gallon)
+for diesel in Luxemburg. Except for the United Kingdom, diesel fuel is taxed on
+average 62¢/gallon( 140/1,000 liters) less than gasoline.61 In December 2005, the
+average end-use prices of gasoline in France and Germany were $5.26/gallon and
+$6.08/gallon, respectively ( 1.170/liter and 1.226/liter), compared with $2.17/gallon
+in the United States — with automotive diesel averaging $3.89/gallon and
+$4.23/gallon in France and Germany, respectively ( 0.865/liter and 0.941/liter),
+compared with $2.45/gallon in the United States.62 The end-use price difference in
+the two fuels appears to correlate with the increasing registration of diesel cars in the
+EU. With higher crude oil prices, the fuel savings advantage of diesel cars should
+become even more compelling.
+
+Diesel fuel demand is “regulatory driven” to an extent. Motor fuel taxes that
+
+favor diesel over gasoline offer one means of redirecting demand, but the tax
+differential may need to be significantly higher than the current 6¢ per gallon
+differential favoring gasoline. Raising motor fuel taxes above the current federal
+level runs counter to current policy. In the aftermath of Hurricane Katrina, when
+gasoline prices surged above $3 per gallon, some states suspended or considered
+suspending taxes on gasoline. However, advocates of energy conservation argued
+
+61 EurActive, Fuel Taxation , Nov. 25, 2003, at [http://www.euractiv.com/Article?
+tcmuri=tcm:29-117495-16&type=LinksDossier], visited Apr. 5, 2006.
+
+62 International Energy Agency, End-user Petroleum Product Prices and Average Crude Oil
+Import Costs, December 2005 , Jan. 6, 2006.
+
+ 
+ CRS-25
+
+that the higher gasoline prices conserved fuel by discouraging driving, thus the motor
+fuel tax should have remained or even increased. If higher motor fuel tax stimulates
+the demand for more fuel-efficient vehicles, as the European experience suggests, the
+inherent fuel efficiency offered by a diesel passenger vehicle becomes more apparent,
+if not desirable. This in turn could act as an additional incentive for producing diesel
+or alternatives such as oil-shale distillates.
+
+ Policy Perspective and Consideration 
+
+Federally sponsored research to develop fuel substitutes from oil shale dates
+
+back the U.S. Synthetic Liquid Fuels Act of 1944 out of World War II concerns for
+oil supplies. Later, in response to the oil embargos of the 1970s, Congress created
+the Synthetic Fuels Corporation. National security had been a motivating concern
+(i.e., to aid the prosecution of the war and to contend with foreign actions that
+interrupt energy supplies). As newly discovered, less-costly-to-produce petroleum
+reserves entered production in the early 1980s, the economic and operating
+conditions of oil shale production became unfavorable. As commercial interests
+backed out of projects, Congress terminated synthetic fuel development. Various
+commercial attempts to exploit the resource met with limited success. Technological
+developments that transformed petroleum refining efficiency, and the discovery of
+new petroleum reserves, shifted private sector interest away from oil shale resources.
+
+The global demand-driven petroleum supply cycle, if true to history, is likely to
+
+exhibit periods of surplus and shortage. Periods of surplus fit well with the just-in-
+time supply model that seeks to hold down inventory costs by minimizing stocks on
+hand. Proponents of the self-correcting petroleum market theory may argue that
+supply interruptions are temporary and that price spikes signal customers to reduce
+consumption. Opponents may argue that reduced consumption is not an option
+during a national security crisis and that there ought to be a “just-in-case”
+contingency in place, such as oil shale. While the threat from future OPEC-like
+embargoes appears unlikely, the President’s goal “to replace more than 75 percent
+of our oil imports from the Middle East by 2025" indicates continuing concern.63
+
+Recent high crude oil prices renewed interest in oil shale, prompting Congress
+
+to include provisions in the Energy Policy Act of 2005 promoting the lease and
+development of federal oil shale holdings. The Act also identified oil shale as a
+strategically important domestic resource and directed the Energy Department to
+coordinate and accelerate its commercial development.
+
+The misconception persists, however, regarding oil shale’s fungibility as a crude
+
+oil substitute. It doesn’t effectively replace crude oil as a gasoline feedstock. Thus,
+policies that attempt to foster oil shale development come into conflict with
+regulatory policies that favor gasoline as transportation fuel. The best use of the
+resource appears to be as feedstock for producing middle-distillate fuels. Regulatory
+policies that are acting to discourage wider use of middle-distillate fuels thus may be
+acting as a disincentive to oil shale production. Congress may wish to consider
+
+63 President George W. Bush, State of the Union , Jan. 31, 2006.
+
+ 
+ CRS-26
+
+whether a special case should be made for oil shale, and whether to exempt the
+middle-distillate fuels produced from regulatory policies that restrict their wider use
+as transportation fuels.
+
+The President’s FY2007 budget request would terminate the Energy
+
+Department’s oil technology research, and the Defense Department’s initiative to
+develop clean fuels from oil shale (among other resources) appears unfunded.64
+
+Whether oil shale can be economically produced, even given the current high
+
+cost of conventionally recovered petroleum, remains unclear. However, without a
+long-term concerted effort to produce oil shale, either through a federal- or private
+sector-sponsored enterprise, the economic viability will remain questionable. The
+expectation of initial high unit costs should be weighed against the offset in demand
+for imported products and the effect on lowering price that competition brings.
+
+64 Personal communication with Dr. Theodore K. Barna, Feb. 8, 2006.
+
+ 
+ CRS-27
+
+ Appendix: Legislative History 
+
+The Pickett Act of 1910 initially authorized withdrawal of potential oil-bearing
+
+lands in California and Wyoming as sources of fuel for the Navy. Executive orders
+later created three Naval Petroleum and Oil Shale Reserves between 1912 and 1927
+by setting aside federal lands believed to contain oil as an emergency reserve.
+
+The U.S. Synthetic Liquid Fuels Act of 1944 (30 USC Secs. 321 to 325)
+
+authorized $30 million over five years for “the construction and operation of
+demonstration plants to produce synthetic liquid fuels from coal, oil shales,
+agricultural and forestry products, and other substances, in order to aid the
+prosecution of the war, to conserve and increase the oil resources of the Nation, and
+for other purposes.” The act also authorized the Interior Secretary to construct,
+maintain, and operate plants producing synthetic liquid fuel from coal, oil shale, and
+agricultural and forestry products. The Bureau of Mines received $87.6 million for
+an 11-year demonstration plant program.
+
+The Defense Production Act of 1950 (Ch. 932, 64 Stat. 798), enacted during the
+
+Korean War, was intended to develop and maintain whatever military and economic
+strength necessary to support collective action through the United Nations. The
+diversion of certain materials and facilities from civilian to military use required
+expansion of production facilities beyond the levels needed to meet civilian demand.
+Section 303 of Title III (Expansion of Production Capacity and Supply) authorized
+the President “extraordinary” procurement power to have liquid fuels processed and
+refined for government use or resale, and to make improvements to government or
+privately owned facilities engaged in processing and refining liquid fuels when it
+would aid the national defense. In 1980, Congress added provisions (P.L. 96-294)
+that related to preparing for terminated or reduced availability of energy supplies for
+national defense needs. Section 305 of the act authorized the President to purchase
+synthetic fuels for the purpose of national defense. Executive Order 12242 then
+directed the Secretary of Defense to determine the quantity and quality of synthetic
+fuel needed to meet national defense needs for procurement.
+
+The Naval Petroleum Reserves Production Act of 1976 (P.L. 94-258), in
+
+reference to Naval Petroleum Reserve No. 4 in Alaska, defined petroleum to include
+crude oil, gases (including natural gas), natural gasoline, and other related
+hydrocarbons, oil shale, and the products of such sources.
+
+The Department of Energy Organization Act of 1977 (P.L. 95-91) transferred
+
+control of the Naval Petroleum and Oil Shale Reserves from the Navy to the
+Department of Energy.
+
+The United States Synthetic Fuels Corporation Act of 1980 (P.L. 96-294)65
+
+amended the Defense Production Act by establishing the U.S. Synthetic Fuels
+Corporation (SFC) “to improve the Nation’s balance of payments, reduce the threat
+of economic disruption from oil supply interruptions, and increase the Nation’s
+
+65 Title I, Part B of the Energy Security Act of 1980.
+
+ 
+ CRS-28
+
+security by reducing its dependence on foreign oil.” The corporation was authorized
+to provide financial assistance to qualified projects that produced synthetic fuel from
+coal, oil shale, tar sands, and heavy oils. Financial assistance could be awarded as
+loans, loan guarantees, price guarantees, purchase agreements, joint ventures, or
+combinations of those types of assistance. An Energy Security Reserve fund was
+also established in the U.S. Treasury and appropriated $19 billion to stimulate
+alternative fuel production. Executive Order 12242 (1980) directed the Secretary of
+Defense to determine the quantity and quality of synthetic fuel needed to meet
+national defense needs for procurement under the Defense Production Act.
+Executive Order 12346 (Synthetic Fuels) of 1982 revoked EO 12242 and provided
+for an orderly transition of synthetic fuel responsibilities from the Department of
+Energy to the United States Synthetic Fuels Corporation.
+
+The Crude Oil Windfall Profit Tax Act of 1980 (P.L. 96-223) ostensibly
+
+provided revenue to maintain the Energy Security Reserve fund. The Internal
+Revenue Code was amended to impose an excise tax on windfall profits of domestic
+producers of taxable crude oil. A production tax credit of $3.00 (1979 dollars) per
+barrel of oil equivalent was provided to stimulate oil shale development. The House
+conference report (H. Rept 96-817) projected $227.3 billion in total revenue from
+the tax after 1988. In the Windfall Profit Tax Account established to hold the
+revenue, 15% had been allocated for energy and transportation. In 1983, the
+Congressional Budget Office estimated that the revenue would only reach 40% of the
+conference report’s projection and only 20% by 1988, as the price of crude oil had
+been lower than projected. Congress repealed the windfall profit tax in 1988 ( P.L.
+100-418).
+
+The House began considering a bill to abolish the SFC with the Synthetic Fuels
+
+Fiscal Responsibility Act of 1985 (H.R. 935). The Energy and Commerce
+Committee debate of the bill (Rept. 99-196) linked abolishing the Corporation to
+reducing the federal deficit and viewed purchasing oil for the Strategic Petroleum
+Reserve as a far more cost effective defense against another embargo by OPEC than
+subsidizing synthetic fuels. The minority view noted that as late as 1983, the
+Department of Defense had certified that synthetic fuel was needed to meet national
+defense needs under Executive Order 12242. In September 1985, the Senate
+Committee on Appropriations report (S.Rept. 99-141) recommended increasing the
+Department of Energy Oil Shale Program budget and reaffirmed the goal of oil shale
+reserves supplying petroleum during a national emergency. Support for the SFC
+could not be sustained, and Congress terminated it under the Consolidated Omnibus
+Reconciliation Act of 1985 (P.L. 99-272). Remaining obligations were transferred
+to the Treasury Department, and the duties of the Chairman of the SFC Board were
+transferred to the Secretary of the Treasury.
+
+The Department of Energy Organization Act of 1977 (P.L. 95-91) transferred
+
+Navy control of the NOSRs to the Department of Energy. The National Defense
+Authorization Act of 1998 (P.L. 105-85) transferred NOSR Nos. 1 and 3, located
+near Rifle, Colorado, from the Department of Energy to the Bureau of Land
+Management. The National Defense Authorization Act of 2000 (P.L. 106-398)
+transferred NOSR No. 2 in Utah to the Ute Indian Tribe.
+
+ 
+ CRS-29
+
+The Oil Shale, Tar Sands, and Other Strategic Unconventional Fuels Act of
+
+200566 declares the strategic importance of domestic oil shale resources and their
+development. The act directs the Secretary of the Interior to commence commercial
+leasing of oil shale on public lands and to establish a task force in cooperation with
+the Secretary of Defense to develop a program for commercially developing strategic
+unconventional fuels, including but not limited to oil shale. Section 2398a.
+(Procurement of Fuel Derived from Coal, Oil Shale, and Tar Sands) directs the
+Secretary of Defense to develop a strategy to use fuel produced from oil shale to help
+meet the fuel requirements of the Department of Defense when the Secretary
+determines that doing so is in the national interest
+
+66 Section 369 of the Energy Policy Act of 2005.
\ No newline at end of file
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+++ b/corpus/politics/text/f28dd03c2450e2aa.txt
@@ -0,0 +1,2848 @@
+Order Code RL33837
+
+ Congressional Authority 
+
+ to Limit U.S. Military Operations in Iraq 
+
+ Updated July 11, 2007 
+
+Jennifer K. Elsea, Michael John Garcia, and Thomas J. Nicola
+
+Legislative Attorneys
+
+American Law Division
+
+ 
+ Congressional Authority 
+
+to Limit U.S. Military Operations in Iraq
+
+ Summary 
+
+On October 16, 2002, President Bush signed the Authorization for Use of
+
+Military Force Against Iraq Resolution of 2002. Since the March 2003 invasion of
+Iraq, Congress has enacted appropriation bills to fund the continuation of the Iraq
+war, including military training, reconstruction, and other aid for the government of
+Iraq. In April, 2007, however, Congress passed a supplemental appropriations bill
+to fund the war that contained conditions and a deadline for ending some military
+operations. The President vetoed the bill, arguing in part that some of its provisions
+are unconstitutional. The current dispute is centered on whether Congress has the
+constitutional authority to legislate limits on the President’s authority to conduct
+military operations in Iraq, even though it did not initially provide express limits.
+Specific issues include whether Congress may, through limitations on appropriations,
+set a ceiling on the number of soldiers or regulate which soldiers the President may
+assign to duty in Iraq, and whether an outright repeal or expiration of the
+authorization for use of military force (AUMF) against Iraq would have any effect.
+
+It has been suggested that the President’s role as Commander in Chief of the
+
+Armed Forces provides sufficient authority for his deployment of troops, and any
+efforts on the part of Congress to intervene could represent an unconstitutional
+violation of separation-of-powers principles. While even proponents of strong
+executive prerogative in matters of war appear to concede that it is within Congress’s
+authority to cut off funding entirely for a military operation, it has been suggested
+that spending measures that restrict but do not end financial support for the war in
+Iraq would amount to an “unconstitutional condition.” The question may turn on
+whether specific proposals involve purely operational decisions committed to the
+President in his role as Commander in Chief, or whether they are instead valid
+exercises of Congress’s authority to allocate resources using its war powers and
+power of the purse.
+
+This report begins by providing background, discussing constitutional
+
+provisions allocating war powers between Congress and the President, and presenting
+a historical overview of relevant court cases. It discusses Congress’s power to
+rescind prior military authorization, concluding, in light of relevant jurisprudence and
+the War Powers Resolution, that the repeal of the AUMF, absent the further denial
+of appropriations or the establishment of a specific deadline for troop withdrawal,
+would likely have little, if any, legal effect on the continuation of combat operations.
+The report discusses Congress’s ability to limit funding for military operations in
+Iraq, examining relevant court cases and prior measures taken by Congress to restrict
+military operations, as well as possible alternative avenues to fund operations if
+appropriations are cut. There follows a summary of relevant measures included in
+the vetoed FY2007 supplemental appropriations bill, H.R. 1591, and the enacted act,
+H.R. 2206. The report provides historical examples of measures that restrict the use
+of particular personnel, and concludes with a brief analysis of arguments that might
+be brought to bear on the question of Congress’s authority to limit the availability of
+troops to serve in Iraq. Although not beyond debate, such a restriction appears to be
+within Congress’s authority to allocate resources for military operations.
+
+ 
+ Contents 
+
+Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+I. Constitutional Provisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+
+Congress’s War Powers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+The Commander-in-Chief Clause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
+
+II. Repeal of Prior Authorization to Use Military Force . . . . . . . . . . . . . . . . . . . 16
+
+Historical Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+Rescinding Military Authorization Versus Cutting Appropriations: 
+
+Procedural and Other Considerations . . . . . . . . . . . . . . . . . . . . . . . . . 19
+
+Legal Consequences of Congressional Rescission 
+
+of Military Authorization, Absent Additional 
+Congressional Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+Judicial Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+Implications of the War Powers Resolution . . . . . . . . . . . . . . . . . . . . 26
+Inherent Presidential Authority to Use Military Force 
+
+Absent Congressional Authorization . . . . . . . . . . . . . . . . . . . . . . 28
+
+III. Use of the Power of the Purse to Restrict Military Operations . . . . . . . . . . . 29
+
+Procedural Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
+Availability of Alternative Funds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
+Redeployment from Iraq: Provisions in the Vetoed Supplemental . . . . . . . 36
+
+Criteria Relating to Troops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
+Benchmarks for Iraqi Government and Dates for Redeployment . . . . 37
+Other Restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
+
+Provisions from the Enacted Supplemental, P.L. 110-28 . . . . . . . . . . . . . . 38
+
+IV. Limiting Deployment of Military Personnel . . . . . . . . . . . . . . . . . . . . . . . . . 40
+
+Analysis and Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
+
+ 
+ Congressional Authority to Limit
+
+U.S. Military Operations in Iraq
+
+ Introduction 
+
+On May 1, 2007, President George W. Bush vetoed the U.S. Troop Readiness,
+
+Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act, H.R.
+1591, in part because of measures designed to limit the U.S. military role in Iraq. He
+called the bill “unconstitutional because it purports to direct the conduct of
+operations of war in a way that infringes upon the powers vested in the presidency
+by the Constitution, including as commander in chief of the Armed Forces.”1 The
+next day, the House of Representatives voted to approve the bill by a vote of 222 to
+203, failing to muster the two-thirds majority necessary to override the veto.2
+Congress then passed a new version of the supplemental appropriations bill, H.R.
+2206 (P.L. 110-128), without providing timetables for withdrawal from Iraq, but
+conditioning the release of reconstruction assistance to Iraq on achievement of certain
+benchmarks by the Iraqi government, unless the President waives the requirements.3
+The House of Representatives agreed to vote on a withdrawal deadline when it takes
+up FY2008 supplemental appropriations, which is expected in September. 
+
+As Congress considers defense authorization and appropriations bills for
+
+FY2008, there may be a renewed focus on whether or to what extent Congress has
+the constitutional authority to legislate limits on the President’s authority to conduct
+military operations in Iraq. Congress may consider measures, for example, to repeal
+the authorization to use force in Iraq, to set deadlines for the withdrawal of most
+troops from Iraq, to set requirements for unit rotations into Iraq, or to make other
+requirements that could affect the deployment of armed forces to Iraq. 
+
+It has been suggested that the President’s role as Commander in Chief of the
+
+Armed Forces provides sufficient authority for his deployment of additional troops,
+and any efforts on the part of Congress to intervene could represent an
+unconstitutional violation of separation-of-powers principles. While even proponents
+of strong executive prerogative in matters of war appear to concede that it is within
+Congress’s authority to cut off funding entirely for a military operation, it has been
+suggested that spending measures that restrict but do not end financial support for the
+
+1 153 CONG. REC. H4315 (daily ed. May 2, 2007) (President’s veto message), also available
+at [http://www.whitehouse.gov/news/releases/2007/05/20070502-1.html].
+
+2 Id. at H4326. 
+
+3 For a detailed analysis of the FY2007 supplemental appropriations bills, see CRS Report
+RL33900, FY2007 Supplemental Appropriations for Defense, Foreign Affairs, and Other
+Purposes , by Stephen Daggett et al .
+
+ 
+ CRS-2
+
+war in Iraq would amount to an “unconstitutional condition.”4 The question may turn
+on whether the President’s decisions on troop deployment and mission assignment
+are purely operational decisions committed to the President in his role as Commander
+in Chief, or whether congressional action to limit the availability of troops and the
+missions they may perform is a valid exercise of Congress’s authority to allocate
+resources using its war powers and power of the purse.
+
+ Background 
+
+On October 16, 2002, Congress passed and President Bush signed the
+
+Authorization for Use of Military Force Against Iraq Resolution of 2002.5 While the
+President noted he had sought a “resolution of support” from Congress to use force
+against Iraq, and appreciated receiving that support, he also stated that:
+
+... my request for it did not, and my signing this resolution does not, constitute
+any change in the long-standing positions of the executive branch on either the
+President’s constitutional authority to use force to deter, prevent, or respond to
+aggression or other threats to U.S. interests or on the constitutionality of the War
+Powers Resolution.6
+
+The President indicated he would continue to consult with Congress and to submit
+written reports to Congress every 60 days on matters relevant to the resolution to use
+force,7 which authorizes the President to use the armed forces of the United States
+
+as he determines to be necessary and appropriate in order to (1) defend the
+national security of the United States against the continuing threat posed by Iraq;
+and (2) enforce all relevant United Nations Security Council resolutions
+regarding Iraq.
+
+The statute required certain conditions to be met prior to the initiation of military
+operations and made periodic reports to Congress mandatory, but did not set a
+timetable or any criteria for determining when to withdraw troops from Iraq. It
+appears to incorporate future UN Security Council resolutions concerning Iraq that
+may be adopted by the Security Council as well as those adopted prior to its
+enactment, effectively authorizing military force not only to compel disarmament but
+to carry out other functions necessary for achieving the goals adopted or that may be
+adopted by the Security Council. Thus, it appears that the resolution authorizes force
+
+4 See, e.g., David B. Rivkin Jr. and Lee A. Casey, What Congress Can (And Can’t) Do on
+Iraq , WASH. POST (January 16, 2007) at A19; see also Charles Tiefer, Can Appropriation
+Riders Speed Our Exit from Iraq? , 42 STAN. J. INT’L L. 291(2006)(predicting arguments that
+would be made to oppose congressional funding restrictions).
+
+5 P.L. 107-243; 116 Stat. 1498. For more background, see CRS Report RL31133,
+ Declarations of War and Authorizations for the Use of Military Force: Historical
+Background and Legal Implications , by Richard F. Grimmett and Jennifer K. Elsea.
+
+6 See President’s Statement on Signing H.J.Res. 114, October 16, 2002, available at
+ [http://usinfo.state.gov/dhr/Archive/2003/Oct/09-906028.html].
+
+7 Id .
+
+ 
+ CRS-3
+
+deemed necessary by the President for so long as Iraq poses a continuing threat to the
+United States and the U.S. military presence is not inconsistent with relevant U.N.
+resolutions.
+
+The resolution does not itself stipulate limitations with respect to the amount of
+
+force that may be used or the resources that may be expended to accomplish the
+authorized objectives; however, Congress may set limits by means of legislation or
+the budgeting process. The Department of Defense has some latitude regarding how
+it allocates funds for various operations, and may have additional statutory authority
+to obligate funds without additional prior express authorization from Congress.
+
+ I. Constitutional Provisions 
+
+At least two arguments support the constitutionality of Congress’s authority to
+
+limit the President’s ability to increase or maintain troop levels in Iraq. First,
+Congress’s constitutional power over the nation’s armed forces provides ample
+authority to legislate with respect to how they may be employed. Under Article I, 
+§ 8, Congress has the power “To lay and collect Taxes ... to ... pay the Debts and
+provide for the common Defence,”“To raise and support Armies,” “To provide and
+maintain a Navy,” “To make Rules for the Government and Regulation of the land
+and naval Forces,” and “To declare War, grant letters of Marque and Reprisal, and
+make Rules concerning Captures on Land and Water,” as well as “To provide for
+calling forth the Militia to execute the Laws of the Union, suppress Insurrections and
+repel Invasions” and “To provide for organizing, arming, and disciplining, the
+Militia, and for governing such Part of them as may be employed in the Service of
+the United States.” Further, Congress is empowered “To make all Laws which shall
+be necessary and proper for carrying into Execution the foregoing Powers ...” as well
+as “all other Powers vested by this Constitution in the Government of the United
+States, or in any Department or Officer thereof.” 
+
+Secondly, Congress has virtually plenary constitutional power over
+
+appropriations, one that is not qualified with reference to its powers in section 8.
+Article I, § 9 provides that “No Money shall be drawn from the Treasury, but in
+Consequence of Appropriations made by Law.” It is well established, as a
+consequence of these provisions, that “no money can be paid out of the Treasury
+unless it has been appropriated by an act of Congress”8 and that Congress can specify
+the terms and conditions under which an appropriation may be used,9 so long as it
+does not impose an unconstitutional condition on the use of the funds.10
+
+8 Cincinnati Soap Co. v. United States, 301 U.S. 308, 321 (1937).
+
+9 Fullilove v. Klutznick, 448 U.S. 448, 474 (1980); South Dakota v. Dole, 483 U.S. 203,
+206-07 (1987). For a scholarly treatment of the Appropriations Clause, see Kate Stith,
+ Congress’ Power of the Purse , 97 YALE L. J. 1343 (1988).
+
+10 United States v. Klein, 80 U.S. (8 Wall.) 128 (1872) (holding invalid an appropriations
+proviso that effectively nullified some effects of a presidential pardon and that appeared to
+prescribe a rule of decision in court cases); United States v. Lovett, 328 U.S. 303
+
+(continued...)
+
+ 
+ CRS-4
+
+On the executive side, the Constitution vests the President with the “executive
+
+Power,” Article II, § 1, cl. 1, and appoints him “Commander in Chief of the Army
+and Navy of the United States,” id ., § 2, cl. 1. The President is empowered, “by and
+with the Advice and Consent of the Senate, to make Treaties,” authorized “from time
+to time [to] give to the Congress Information on the State of the Union, and [to]
+recommend to their Consideration such Measures as he shall judge necessary and
+expedient,” and bound to “take Care that the Laws be faithfully executed.” Id ., § 3.
+He is bound by oath to “faithfully execute the Office of President of the United
+States,” and, to the best of his “Ability, preserve, protect and defend the Constitution
+of the United States.” Id ., § 1, cl. 8.
+
+It is clear that the Constitution allocates powers necessary to conduct war
+
+between the President and Congress. While the ratification record of the Constitution
+reveals little about the meaning of the specific war powers clauses, the importance
+of preventing all of those powers from accumulating in one branch appears to have
+been well understood,11 and vesting the powers of the sword and the purse in separate
+hands appears to have been part of a careful design.12
+
+ It is generally agreed that some aspects of the exercise of those powers are
+
+reserved to the Commander in Chief, and that Congress could conceivably legislate
+beyond its authority in such a way as to intrude impermissibly into presidential
+power. The precise boundaries separating legislative from executive functions,
+however, remain elusive. There can be little doubt that Congress would exceed its
+bounds if it were to confer exclusive power to direct military operations on an officer
+not subordinate to the President,13 or to purport to issue military orders directly to
+subordinate officers.14 At the same time, Congress’s power to make rules for the
+
+10 (...continued)
+(1946)(invalidating as a bill of attainder an appropriations provision denying money to pay
+salaries of named officials).
+
+11 See LOUIS FISHER, PRESIDENTIAL WAR POWER 7 (2d ed. 2004)(noting that allocation of
+war powers to Congress was a break with monarchial theories, under which all such powers
+belonged to the executive); id . at 8-12.
+
+12 See WILLIAM C. BANKS AND PETER RAVEN-HANSEN, NATIONAL SECURITY LAW AND THE
+POWER OF THE PURSE 27-32(1994).
+
+13 Congress has by statute provided that the President must issue orders to subordinate
+military commands through the appropriate chain of command rather than directly. See
+ FRANCIS D. WORMUTH AND EDWIN B. FIRMAGE, TO CHAIN THE DOG OF WAR: THE WAR
+POWER OF CONGRESS IN HISTORY AND LAW 93(2nd ed. 1989)(citing the Command of the
+Army Act of 1867, 14 Stat. 485, 486-87, which required that “all orders and instructions
+relating to military operations” be “issued through the General of the Army,” and made
+orders issued contrary to the provision punishable by prison sentence from two to twenty
+years). Congress has also authorized judges to issue orders directed to military commanders
+requiring them to provide military aid to marshals for the arrest of persons accused of crimes
+against the United States who were on board foreign ships in U.S. harbors. 2 Stat. 339
+(1805).
+
+14 But see id . at 93-94 (asserting that during the Reconstruction period following the Civil
+War, the “army was given its orders directly by Congress,” and that President Andrew
+
+(continued...)
+
+ 
+ CRS-5
+
+government and regulation of the armed forces provides it wide latitude for
+restricting the nature of orders the President may give. Congress’s power of
+appropriations gives it ample power to supply or withhold resources, even if the
+President deems them necessary to carry out planned military operations.15
+
+ Congress’s War Powers 
+
+The power “To Declare War” has long been construed to mean not only that
+
+Congress can formally take the nation into war but also that it can authorize the use
+of the armed forces for military expeditions that may not amount to war.16 While a
+restrictive interpretation of the power “To declare War” is possible, for example, by
+viewing the Framers’ use of the verb “to declare” rather than “to make”17 as an
+indication of an intent to limit Congress’s ability to affect the course of a war once
+it is validly commenced,18 Congress’s other powers over the use of the military would
+likely fill any resulting void. In practice, courts have not sought to delineate the
+boundaries of each clause relating to war powers or identify gaps between them to
+find specific powers that are denied to Congress.19
+
+Early exercises of Congress’s war powers may shed some light on the original
+
+understanding of how the war powers clauses might empower Congress to limit the
+President’s use of the armed forces. In the absence of a standing army, early
+presidents were constrained to ask Congress for support in advance of undertaking
+
+14 (...continued)
+Johnson’s efforts to circumvent the statute were cited in the ninth article of impeachment
+against him, although no proof was offered at trial).
+
+15 For a discussion of theories asserting the presidential prerogative to spend without
+appropriations when necessary for military operations, see generally Colonel Richard D.
+Rosen, Funding “Non-traditional” Military Operations: The Alluring Myth of a
+Presidential Power of the Purse , 155 MIL. L. REV. 1 (1998); see also Major Brian A.
+Hughes, Uses and Abuses of O&M Funded Construction: Never Build on a Foundation of
+Sand , 2005-AUG ARMY LAW. 1 (describing how fiscal law constrains military spending,
+sometimes impeding military operations).
+
+16 Bas v. Tingy, 4 U.S. 37 (1800).
+
+17 The Framers’ decision to substitute “declare” for “make” has generally been interpreted
+to allow the President the authority to repel sudden attacks. 2 MAX FARRAND, THE
+RECORDS OF THE FEDERAL CONVENTION OF 1787, 318-19 (rev. ed. 1937)(explanation of
+James Madison and Elbridge Gerry on their motion to amend text).
+
+18 Cf. John C. Yoo, War and the Constitutional Text , 69 U. CHI. L. REV. 1639, 1669-71
+(2002)(arguing that “to declare” means to formally recognize rather than to authorize or
+commence).
+
+19 See 3 JOSEPH STORY, COMMENTARIES ON THE CONSTITUTION §§ 1170 - 71 (1833) (stating
+that the powers to issue letters of marque and reprisal and to authorize captures are
+incidental to the power to declare war, implying their express mention was unnecessary, but
+noting that these “incidental” powers may also be employed during peace). But see, e.g. , J.
+Terry Emerson, War Powers Legislation , 74 W. Va. L. Rev. 53, 62 (1972)(arguing that early
+opinions related to the Quasi-War with France, often advanced for the proposition that
+Congress is empowered to regulate military operations that do not amount to war, should
+be read as strict interpretations of Congress’s power to make rules for captures).
+
+ 
+ CRS-6
+
+any military operations.20 Congress generally provided the requested support and
+granted the authority to raise the necessary troops to defend the frontiers from
+deprivations by hostile Indians21 and to build a navy to protect U.S. commerce at
+sea.22 Congress, in exercising its authority to raise the army and navy, sometimes
+raised forces for specific purposes, which may be viewed as both an implicit
+authorization to use the forces for such purposes and as an implicit limitation on their
+use.23 On the other hand, Congress often delegated broad discretion to the President
+within those limits, and appears to have acquiesced to military actions that were not
+explicitly authorized.24 
+
+In several early instances, Congress authorized the President to use military
+
+forces for operations that did not amount to a full war. Rather than declaring a
+formal war with France, Congress authorized the employment of the naval forces for
+limited hostilities. The Third Congress authorized the President to lay and enforce
+embargoes of U.S. ports, but only while Congress was not in session (and embargo
+orders were to expire 15 days after the commencement of the next session of
+Congress).25 The Fifth Congress authorized the President to issue instructions to the
+
+20 See ABRAHAM SOFAER, WAR, FOREIGN AFFAIRS AND CONSTITUTIONAL POWER 116-17
+(1976) (describing President Washington’s efforts to obtain support for military efforts,
+including a build-up of military strength to preserve peace and maintain U.S. stature among
+nations).
+
+21 See , e.g. , Act of March 3d, 1791, for raising and adding another Regiment to the Military
+Establishment of the United States, and for making further provision for the protection of
+the frontier, 1 Stat. 222; Act of March 5, 1792, 1 Stat. 241 (adding three regiments for three
+years or until peace with Indian tribes was established); Act of July 16, 1798, 1 Stat. 604
+(authorizing the President to raise twelve additional regiments of infantry and six troops of
+light dragoons during the continuance of differences with the French Republic).
+
+22 See , e.g., Act of March 27, 1794, To provide a naval armament, 1 Stat. 351 (“Whereas the
+depredations committed by Algerine corsairs render it necessary...” authorizing the building
+and manning of six ships of specific types, until the establishment of peace with the
+Regency of Algiers)(amended in 1796 to remove restrictions so that vessels could be used
+for other purposes, 1 Stat. 453); Act of April 27, 1798, To provide an additional Armament
+for the protection of the Trade of the United States..., 1 Stat. 552; Act of June 22, 1798, 1
+Stat. 569 (authorizing the President “to increase the strength of any revenue cutter, for the
+purposes of defence, against hostilities near the sea coast” by manning the vessels with up
+to 70 seamen and marines).
+
+23 Some proposals explicitly to limit how the vessels could be employed were stricken prior
+to enactment, but the congressional debates left unclear whether the majority of members
+thought the restrictions unconstitutional or merely unwise, or whether the absence of
+specific authority was meant to be a limitation. See SOFAER, supra note 20, at 147-54. The
+John Adams Administration interpreted the legislation restrictively, and instructed naval
+commanders accordingly that their authority was to be “partial and limited.” See id. at 156.
+
+24 See id. at 129 (noting that offensive actions against Wabash Indians and against a British
+fort may have exceeded express statutory authorization but were authorized by implication
+through appropriations). 
+
+25 Act of June 4, 1794, 1 Stat. 372. See also Act of June 5, 1794 §§ 7- 8, 1 Stat. 381, 384
+(authorizing the President to use armed forces to detain violators and compel foreign ships
+
+(continued...)
+
+ 
+ CRS-7
+
+commanders of public armed ships to capture certain French armed vessels and to
+recapture ships from them,26 and to retaliate against captured French citizens who had
+seized U.S. citizens and subjected them to mistreatment.27 Congress also authorized
+U.S. merchant vessels to defend themselves against French vessels.28 The Supreme
+Court treated these statutes as authorizing a state of “partial war” between the United
+States and France.29 Such an undeclared war was described as an “imperfect” war,
+as distinguished from a “Solemn” or “perfect” war, declared as such, in that, in the
+first case, all members of one nation are at war with all members of the other nation;
+in the second case, those who are authorized to commit hostilities act “under special
+authority.”30 This suggests an early understanding that Congress’s war powers
+extend to establishing the scope of hostilities to be carried out by the armed forces.
+
+In the majority of cases, however, it appears that Congress has given broad
+
+deference to the President to decide how much of the armed forces to employ in a
+given situation. After Tripoli declared war against the United States in 1801 and
+U.S. vessels were already engaged in defensive actions against them, Congress did
+not enact a full declaration of war. Rather, it issued a sweeping authorization for the
+commissioning of privateers, captures, and other actions to “equip, officer, man, and
+employ such of the armed vessels of the United States as may be judged requisite by
+the President of the United States , for protecting effectually the commerce and
+seamen thereof on the Atlantic ocean, the Mediterranean and adjoining seas,” as well
+as to “cause to be done all such other acts of precaution or hostility as the state of
+war will justify, and may, in his opinion, require .”31 In declaring war against Great
+Britain in 1812, Congress authorized the President to “use the whole land and naval
+force of the United States to carry the same into effect, and to issue to private armed
+vessels of the United States commissions or letters of marque and general reprisal,
+in such form as he shall think proper....”32
+
+That Congress has traditionally left it up to the President to decide how much
+
+of the armed forces to employ in a given conflict need not imply that such deference
+is constitutionally mandated. The fact that Congress has seen fit to include such
+
+25 (...continued)
+to depart).
+
+26 Act of May 28, 1798, 1 Stat. 561. See also Act of July 9, 1798, 1 Stat. 578.
+
+27 Act of March 3, 1799, 1 Stat. 743 (empowering and requiring the President to “cause the
+most rigorous retaliation to be executed on [French suspects who] have been or hereafter
+may be captured in pursuance of any of the laws of the United States”).
+
+28 1 Stat. 572.
+
+29 Bas v. Tingy, 4 U.S.(Dall.) 37 (1800).
+
+30 Id . at 40. See also Talbot v. Seeman, 5 U.S.(Cranch) 1, 28 (1801)(“Congress may
+authorize general hostilities ... or partial hostilities’”).
+
+31 Act of February 6, 1802, 2 Stat.129 (emphasis added). For more examples of
+authorizations to use force and declarations of war, see CRS Report RL31133, Declarations
+of War and Authorizations for the Use of Military Force: Historical Background and Legal
+Implications , by Richard F. Grimmett and Jennifer K. Elsea.
+
+32 Act of June 18, 1812, ch. 102, 2 Stat 755.
+
+ 
+ CRS-8
+
+language may just as easily be read as an indication that Congress believes that the
+decision is its to delegate. Under this view, even in the case of a declaration of war,
+Congress retains the power to authorize the President to use only a portion of the
+armed forces to engage in a particular conflict. On the other hand, some have argued
+that the President is authorized to deploy all of the armed forces as he sees fit, with
+or without an express authorization to use force or a declaration of war.33 According
+to this theory, in essence, Congress can stop the deployment of military forces only
+by cutting appropriations and discharging the troops. 
+
+Congress has also used its authority to provide for the organization and
+
+regulation of the armed forces to regulate how military personnel are to be organized
+and employed. The earliest statutes prescribed in fairly precise terms how military
+units were to be formed and commanded. For example, the 1798 act establishing the
+Marine Corps mandated the raising of a corps to consist of “one major, four captains,
+sixteen first lieutenants, twelve second lieutenants, forty-eight sergeants, forty-eight
+corporals, thirty-two drums and fifes, and seven hundred and twenty privates....”34
+Congress authorized the President to appoint certain other officers as necessary if he
+were to assign the Marine Corps or any part of it to shore duty, and to assign the
+detachment to duty in “forts and garrisons of the United States, on the sea-coast, or
+any other duty on shore.” Officers of the Marine Corps could be detached to serve
+on board frigates and other armed vessels. The Marine Corps was increased in size
+and reorganized in 1834 to be commanded by a colonel, with the proviso that no
+Marine Corps officer could be placed in command of a navy yard or vessel of the
+United States.35
+
+It appears to have been understood that personnel and units authorized to
+
+perform certain duties could not be assigned to perform other duties without
+authorization from Congress. In 1808, when Congress authorized eight new
+regiments of specific types and composition, it felt compelled to include language
+making members of the light dragoon regiment liable to “serve on foot as light
+infantry” until sufficient horses and other accouterments could be provided.36 The
+Supreme Court later interpreted an 1802 statute providing for the establishment of
+the Corps of Engineers, although broadly worded to permit the President to direct
+that its members serve such duty in such places as he saw fit, to authorize only
+engineering duties:
+
+33 See , e.g. , Bradley Larschan, The War Powers Resolution: Conflicting Constitutional
+Powers, The War Powers, and U.S. Foreign Policy, 16 DENVER J. INT’L L. & POL’Y 33, 45
+(1987) (arguing that once Congress has raised an army and appropriated funds for it, “it falls
+to the President to use the armed forces in his capacity to conduct foreign policy in
+situations short of war”). The author states that it is “clear that the Congress may prohibit
+the use of U.S. forces in certain areas by statute,” but that “it is the President who orders
+deployment of the troops.” Id . at 49. 
+
+34 1 Stat. 594, 595 (1798). 
+
+35 4 Stat. 712, 713 (1834).
+
+36 2 Stat. 481, 483 (1808).
+
+ 
+ CRS-9
+
+But, however broad this enactment is in its language, it never has been supposed
+to authorize the President to employ the corps of engineers upon any other duty,
+except such as belongs either to military engineering, or to civil engineering.37
+
+ The Commander-in-Chief Clause 
+
+Early in the nation’s history, the Commander-in-Chief power was understood
+
+to connote “nothing more than the supreme command and direction of the military
+and naval forces, as first general and admiral of the confederacy.”38 Concurring in
+that view in 1850, Chief Justice Taney stated:
+
+[The President’s] duty and his power are purely military. As Commander-in-
+Chief, he is authorized to direct the movements of the naval and military forces
+placed by law at his command, and to employ them in the manner he may deem
+most effectual to harass and conquer and subdue the enemy.39
+
+This formula, taken alone, provides only an approximate demarcation of the line
+separating Congress’s role from the President’s. Advocates of a strong role for
+Congress might characterize a legislative effort to limit the number of troops
+available in Iraq as placing troops “by law” under the President’s command, while
+proponents of a strong executive would likely view it as a limitation on the
+President’s ability to “employ them in the manner” he sees fit. With respect to the
+latter argument, however, it should be noted that the particular question before the
+ Fleming Court did not call into question the extent to which Congress could restrict
+the manner of employing troops once placed at the command of the President.
+
+Other early cases demonstrate Congress’s authority to restrict the President’s
+
+options for the conduct of war. In Little v. Barreme ,40 Chief Justice Marshall had
+occasion to recognize congressional war power and to deny the exclusivity of
+presidential power. There, after Congress had authorized limited hostilities with
+France, a U.S. vessel under orders from the President had seized what its commander
+believed was a U.S. merchant ship bound from a French port, allegedly carrying
+contraband material. Congress had, however, provided by statute only for seizure of
+such vessels bound to French ports.41 Upholding an award of damages to the ship’s
+owners for wrongful seizure, the Chief Justice said:
+
+It is by no means clear that the president of the United States whose high duty it
+is to ‘take care that the laws be faithfully executed,’ and who is commander in
+chief of the armies and navies of the United States, might not, without any
+special authority for that purpose in the then existing state of things, have
+empowered the officers commanding the armed vessels of the United States, to
+seize and send into port for adjudication, American vessels which were forfeited
+
+37 Gratiot v. United States, 40 U.S. (15 Pet.) 336, 371 (1841)(finding that the President could
+contract for other services but must pay an additional stipend for them from other funds)
+
+38 The Federalist , No. 69 (Alexander Hamilton).
+
+39 Fleming v. Page, 50 U.S. (9 How.) 603, 615 (1850). 
+
+40 6 U.S. (2 Cr.) 170 (1804).
+
+41 1 Stat. 613 (1799).
+
+ 
+ CRS-10
+
+by being engaged in this illicit commerce. But when it is observed that [an act of
+Congress] gives a special authority to seize on the high seas, and limits that
+authority to the seizure of vessels bound or sailing to a French port, the
+legislature seems to have prescribed that the manner in which this law shall be
+carried into execution, was to exclude a seizure of any vessel not bound to a
+French port.42
+
+Accordingly, the Court held, the President’s instructions exceeded the authority
+granted by Congress and were not to be given force of law, even in the context of the
+President’s military powers and even though the instructions might have been valid
+in the absence of contradictory legislation.
+
+In Bas v. Tingy ,43 the Court looked to congressional enactments rather than
+
+plenary presidential power to uphold military conduct related to the limited war with
+France. The following year, in Talbot v. Seeman ,44 the Court upheld as authorized by
+Congress a U.S. commander’s capture of a neutral ship, saying that “[t]he whole
+powers of war being, by the constitution of the United States, vested in congress, the
+acts of that body can alone be resorted to as our guides in this inquiry.” During the
+War of 1812, the Court recognized in Brown v. United States ,45 that Congress was
+empowered to authorize the confiscation of enemy property during wartime, but that
+absent such authorization, a seizure authorized by the President was void.
+
+The onset of the Civil War provided some grist for later assertions of unimpeded
+
+presidential prerogative in matters of war. In the Prize Cases ,46 the Supreme Court
+sustained the blockade of Southern ports instituted by President Lincoln in April,
+1861, at a time when Congress was not in session. Congress had at the first
+opportunity ratified the President’s actions,47 so that it was not necessary for the
+Court to consider the constitutional basis of the President’s action in the absence of
+congressional authorization or in the face of any prohibition. Nevertheless, the Court
+approved the blockade five-to-four as an exercise of presidential power alone, on the
+basis that a state of war was a fact and that, the nation being under attack, the
+President was bound to take action without waiting for Congress.48 The case has
+frequently been cited to support claims of greater presidential autonomy by reason
+of his role as Commander in Chief.
+
+42 6 U.S. (2 Cr.) at 177-178.
+
+43 4 U.S. (4 Dall. ) 37 (1800).
+
+44 5 U.S. (1 Cr.) 1, 28 (1801).
+
+45 12 U.S. (8 Cr.) 110 (1814).
+
+46 67 U.S. (2 Bl. ) 635 (1863).
+
+47 12 Stat. 326 (1861)(ratifying all “acts, proclamations, and orders” done by the President
+“respecting the army and navy ... and calling out or relating to the militia”).
+
+48 67 U.S. (2 Bl. ) at 668 (“[The President] does not initiate war, but is bound to accept the
+challenge without waiting for any special legislative authority.”). The minority argued that
+only congressional authorization could stamp an insurrection with the character of war.
+Later, a unanimous Court adopted the majority view. The Protector, 79 U.S. (12 Wall.) 700
+(1872).
+
+ 
+ CRS-11
+
+However, it should be recalled that where Lincoln’s suspension of the Writ of
+
+Habeas Corpus varied from legislation enacted later to ratify it, the Court looked to
+the statute49 rather than to the executive proclamation50 to determine the breadth of
+its application.51 The Chief Justice described the allocation of war powers as follows:
+
+The power to make the necessary laws is in Congress; the power to execute in the
+President. Both powers imply many subordinate and auxiliary powers. Each
+includes all authorities essential to its due exercise. But neither can the President,
+in war more than in peace, intrude upon the proper authority of Congress, nor
+Congress upon the proper authority of the President....52
+
+The Chief Justice described the Commander-in-Chief power as entailing “the
+command of the forces and the conduct of campaigns,”53 but nevertheless agreed that
+military trials of civilians accused of violating the law of war in Union states were
+invalid without congressional approval, despite the government’s assertion that the
+“[Commander in Chief’s] power to make an effectual use of his forces [must include
+the] power to arrest and punish one who arms men to join the enemy in the field
+against him.”54
+
+On the other hand, the Supreme Court has also suggested that the President has
+
+some independent authority to employ the armed forces, at least in the absence of
+contrary congressional action. In the 1890 case of In re Neagle , the Supreme Court
+suggested, in dictum, that the President has the power to deploy the military abroad
+to protect or rescue persons with significant ties to the United States. Discussing
+examples of the executive lawfully acting in the absence of express statutory
+authority, Justice Miller approvingly described the Martin Koszta affair, in which an
+American naval ship intervened to prevent a lawful immigrant from being captured
+by an Austrian vessel, despite the absence of clear statutory authorization.55 Only one
+
+49 Act of March 3d, 1863, 12 Stat. 755 (authorizing the suspension of habeas corpus, but
+with limitations in Union states to those held as prisoners of war; all others were to be
+indicted or freed.)
+
+50 Proclamation of September 15, 1863, 13 Stat. 734 (suspending habeas corpus with respect
+to those in federal custody as military offenders or “as prisoners of war, spies, or aiders and
+abettors of the enemy”).
+
+51 Ex parte Milligan, 71 U.S. (4 Wall.) 2 (1866). 
+
+52 Id . at 139 (Chase, C.J., concurring).
+
+53 Id . at 139 (“Congress cannot direct the conduct of campaigns, nor can the President, or
+any commander under him, without the sanction of Congress, institute tribunals for the trial
+and punishment of offences, either of soldiers or civilians, unless in cases of a controlling
+necessity...”).
+
+54 Id. at 17 (government argument).
+
+55 In re Neagle, 135 U.S. 1, 64 (1890) (describing the incident and rhetorically asking,
+“Upon what act of congress then existing can any one lay his finger in support of the action
+of our government in this matter?”). For further discussion, see LOUIS HENKIN, FOREIGN
+AFFAIRS AND THE U.S. CONSTITUTION 347-348 (2nd ed. 2002); WORMUTH & FIRMAGE, supra
+ note 13, at 154 (stating that the U.S. captain had acted against the President’s orders, but
+
+(continued...)
+
+ 
+ CRS-12
+
+federal court, in an 1860 opinion, has clearly held that in the absence of congressional
+authorization, the President has authority to deploy military forces abroad to protect
+U.S. persons (and property).56 Nevertheless, there historically appears to be some
+support for this view by both the executive and legislative branches.57 However, the
+
+55 (...continued)
+that President Pierce justified the action to Congress, which later awarded the captain a
+medal). In an earlier opinion, the Court had also stated in dictum that one of the privileges
+of a U.S. citizen is “to demand the care and protection of the Federal government over his
+life, liberty, and property when on the high seas or within the jurisdiction of a foreign
+government.” Slaughter-House Cases , 83 U.S. 36, 79 (1872). It should be noted that Koszta
+was not a U.S. citizen, but a legal immigrant who had declared an intention to apply for
+citizenship. Accordingly, an 1868 statute authorizing the use of any means “not amounting
+to acts of war” to obtain the release of U.S. citizens was likely inapplicable. Expatriation Act
+of July 27, 1868, 15 Stat. 223.
+
+56 Durand v. Hollins, 8 Fed. Cas. 111 (C.C.S.D.N.Y. 1860) (Nelson, Circuit Justice) (holding
+that a Navy commander was not civilly liable for damages caused by his forces during an
+1854 action to protect U.S. citizens and property in Greytown, Nicaragua). In an opinion
+by Circuit Justice Nelson, the Court held that the Commander was not liable because the
+military action was pursuant to a valid exercise of federal authority to be exercised by the
+President:
+
+...as it respects the interposition of the executive abroad, for the protection of the
+lives or property of the citizen, the duty must, of necessity, rest in the discretion
+of the president. Acts of lawless violence, or of threatened violence to the citizen
+or his property, cannot be anticipated and provided for; and the protection, to be
+effectual or of any avail, may, not unfrequently, require the most prompt and
+decided action. Under our system of government, the citizen abroad is as much
+entitled to protection as the citizen at home. Id. at 112.
+
+57 See GAO, Office of Compt. Gen., President - Authority - Protection of American Lives
+and Property Abroad , 55 Comp. Gen. 1081 (1975) (describing historical practice and the
+weight of scholarly authority as supporting the power of the President to order military
+rescue operations in the absence of congressional authorization); Dept. of Justice, Office of
+Legal Counsel, 4A U.S. OP. OFF. LEGAL COUNSEL 185, Presidential Power to Use the
+Armed Forces Abroad Without Statutory Authorization (1980) (alleging presidential
+authority to deploy forces to protect, and retaliate for injuries suffered by, U.S. persons and
+property). For discussion of the deployment of military forces to protect U.S. persons or
+property, see FISHER, supra note 11, at 57-58 (describing historical practice, and noting mid-
+20th century study listing 148 examples of this occurrence); ARTHUR M. SCHLESINGER, JR.,
+THE IMPERIAL PRESIDENCY 54-57 (rev. ed. 2004)(discussing mid-nineteenth century
+instances where presidents unilaterally committed forces to protect U.S. persons or
+property). The number and degree to which these actions occurred without congressional
+authorization is the subject to some debate. See WORMUTH & FIRMAGE, supra note 13, at
+135-51(discussing and disputing validity of various lists of military actions compiled to
+demonstrate historical prevalence of presidential war-making). For example, some argue
+that President Jefferson’s ordering of the Navy to protect American shipping from Barbary
+pirates was done without congressional approval, while others view these orders as having
+been issued pursuant to legislation providing for a “naval peace establishment.” Compare
+ Dept. of Justice, Off. of Legal Counsel, supra , at 187 (describing Jefferson’s use of the
+Navy as a “famous early example” of President’s acting without congressional authorization
+to protect U.S. interests) with FISHER, supra note 11, at 35-36 (characterizing the orders as
+
+(continued...)
+
+ 
+ CRS-13
+
+scope of any such authority remains unclear, as does the degree to which it may be
+limited by an act of Congress.
+
+The expansion of presidential power related to war, asserted as a combination
+
+of Commander-in-Chief authority and the President’s inherent authority over the
+nation’s foreign affairs, began in earnest in the twentieth century. In United States
+v. Curtiss-Wright Export Corp ,58 the Supreme Court confirmed that the President
+enjoys greater discretion when acting with respect to matters of foreign affairs than
+may be the case when only domestic issues are involved. In that case, Congress,
+concerned with the outside arming of the belligerents in the war between Paraguay
+and Bolivia, had authorized the President to proclaim an arms embargo if he found
+that such action might contribute to a peaceful resolution of the dispute. President
+Franklin Roosevelt issued the requisite finding and proclamation, and Curtiss-Wright
+and associate companies were indicted for violating the embargo. They challenged
+the statute, arguing that Congress had failed adequately to elaborate standards to
+guide the President’s exercise of the power thus delegated.59 Justice Sutherland
+concluded that the limitations on delegation in the domestic field were irrelevant
+where foreign affairs are involved, a result he based on the premise that foreign
+relations is exclusively an executive function combined with his constitutional model
+positing that internationally, the power of the federal government is not one of
+enumerated but of inherent powers, emanating from concepts of sovereignty rather
+than the Constitution. The Court affirmed the convictions, stating that:
+
+It is important to bear in mind that we are here dealing not alone with an
+authority vested in the President by an exertion of legislative power, but with
+such an authority plus the very delicate, plenary and exclusive power of the
+President as the sole organ of the federal government in the field of international
+relations — a power which does not require as a basis for its exercise an act of
+Congress, but which, of course, like every other governmental power, must be
+exercised in subordination to the applicable provisions of the Constitution. It is
+quite apparent that if, in the maintenance of our international relations,
+embarrassment — perhaps serious embarrassment — is to be avoided and
+success for our aims achieved, congressional legislation which is to be made
+effective through negotiation and inquiry within the international field must often
+accord to the President a degree of discretion and freedom from statutory
+restriction which would not be admissible were domestic affairs alone involved.
+Moreover, he, not Congress, has the better opportunity of knowing the conditions
+which prevail in foreign countries, and especially is this true in time of war.60
+
+57 (...continued)
+being issued pursuant to congressional authorization, and noting that Jefferson denied
+having inherent authority to commit such acts). Whether such usage would legitimate the
+authority is also subject to debate. See WORMUTH & FIRMAGE, supra note 13, at 135.
+
+58 299 U.S. 304 (1936).
+
+59 The Supreme Court had recently held that the Constitution required Congress to elaborate
+standards when delegating authority to the President. Schechter Poultry Corp. v. United
+States, 295 U.S. 495 (1935).
+
+60 299 U.S. at 319-20.
+
+ 
+ CRS-14
+
+The case is cited frequently to support a theory of presidential power not subject
+
+to restriction by Congress, although the case in fact involved an exercise of authority
+delegated by Congress. Curtiss-Wright remains precedent admonishing courts to
+show deference to the President in matters involving international affairs, including
+by interpreting ambiguous statutes in such a manner as to increase the President’s
+discretion.61 The case has also been cited in favor of broad presidential discretion to
+implement statutes related to military affairs.62 To the extent, however, that Justice
+Sutherland interpreted presidential power as being virtually plenary in the realms of
+foreign affairs and national defense, the case has not been followed to establish that
+Congress lacks authority in these areas.
+
+The constitutional allocation of war powers between the President and
+
+Congress, where Congress had not delegated the powers exercised by the President,
+was described by Justice Jackson, concurring in the Steel Seizure Case63:
+
+The Constitution expressly places in Congress power “to raise and support
+Armies” and “to provide and maintain a Navy.” This certainly lays upon
+Congress primary responsibility for supplying the armed forces. Congress alone
+controls the raising of revenues and their appropriation and may determine in
+what manner and by what means they shall be spent for military and naval
+procurement....
+
+There are indications that the Constitution did not contemplate that the title
+Commander in Chief of the Army and Navy will constitute him also Commander
+in Chief of the country, its industries and its inhabitants. He has no monopoly
+of “war powers,” whatever they are. While Congress cannot deprive the
+President of the command of the army and navy, only Congress can provide him
+any army or navy to command.
+
+The Jackson opinion is commonly understood to establish that whatever powers the
+President may exercise in the absence of congressional authorization, the President
+may act contrary to an act of Congress only in matters involving exclusive
+presidential prerogatives.64
+
+61 See Haig v. Agee, 453 U.S. 280, 291, 293-294 & n. 24, 307-308 (1981); Sale v. Haitian
+Centers Council, Inc., 509 U.S. 155 (1993)(construing treaty and statutory provisions as not
+limiting presidential discretion in interdicting refugees on high seas in the light of the
+President’s “unique responsibility” in foreign and military affairs, citing Curtiss-Wright ).
+
+62 See Loving v. United States, 517 U.S. 748 (1996).
+
+63 Youngstown Sheet and Tube Co. v. Sawyer, 343 U.S. 579, 641 (1952).
+
+64 Justice Jackson’s concurrence took note of the fact that Curtiss-Wright did not involve a
+case in which the President took action contrary to an act of Congress. Id . at 635-36 &n.2.
+ Curtiss-Wright , he said
+
+involved, not the question of the President’s power to act without congressional
+authority, but the question of his right to act under and in accord with an Act of
+Congress. The constitutionality of the Act under which the President had
+proceeded was assailed on the ground that it delegated legislative powers to the
+President. Much of the Court’s opinion is dictum , but the ratio decidendi is
+
+(continued...)
+
+ 
+ CRS-15
+
+Presidents from Truman to George W. Bush have claimed independent
+
+authority to commit U.S. armed forces to involvements abroad absent any
+Congressional participation other than consultation and after-the-fact financing. In
+1994, for example, President Clinton based his authority to order the participation of
+U.S. forces in NATO actions in Bosnia-Herzegovina on his “constitutional authority
+to conduct U.S. foreign relations” and as his role as Commander in Chief,65 and
+protested efforts to restrict the use of military forces there and elsewhere as an
+improper and possibly unconstitutional limitation on his “command and control” of
+U.S. forces.66 Ever since Congress passed the War Powers Resolution over President
+Nixon’s veto, all Presidents have regarded it as an unconstitutional infringement on
+presidential powers.67
+
+In the context of what it terms the “Global War on Terror,” the Bush
+
+Administration has claimed that the President’s commander-in-chief authority entails
+inherent authority with respect to the capture and detention of suspected terrorists,
+
+64 (...continued)
+
+contained in the following language: 
+
+When the President is to be authorized by legislation to act in respect
+of a matter intended to affect a situation in foreign territory, the
+legislator properly bears in mind the important consideration that the
+form of the President’s action - or, indeed, whether he shall act at all
+- may well depend, among other things, upon the nature of the
+confidential information which he has or may thereafter receive, or
+upon the effect which his action may have upon our foreign relations.
+This consideration, in connection with what we have already said on
+the subject, discloses the unwisdom of requiring Congress in this field
+of governmental power to lay down narrowly definite standards by
+which the President is to be governed. As this court said in Mackenzie
+v. Hare, 239 U.S. 299, 311 , ‘As a government, the United States is
+invested with all the attributes of sovereignty. As it has the character
+of nationality it has the powers of nationality, especially those which
+concern its relations and intercourse with other countries. We should
+hesitate long before limiting or embarrassing such powers .’ (Italics
+supplied [by Justice Jackson]) Id. , at 321-322.
+
+That case does not solve the present controversy. It recognized internal and
+external affairs as being in separate categories, and held that the strict limitation
+upon congressional delegations of power to the President over internal affairs
+does not apply with respect to delegations of power in external affairs. It was
+intimated that the President might act in external affairs without congressional
+authority, but not that he might act contrary to an Act of Congress.
+
+65 30 WEEKLY COMP. PRES. DOC. 406 (March 2, 1994).
+
+66 See Interview with Radio Reporters, 1993 PUB. PAPERS 1763-64; see also FISHER, supra
+ note 11, at 184.
+
+67 P.L. 93-148, 87 Stat. 555, codified at 50 U.S.C. § 1541 et seq. See CRS Report RL33532,
+ The War Powers Resolution: Presidential Compliance , by Richard F. Grimmett.
+
+ 
+ CRS-16
+
+authority he has claimed cannot be infringed by legislation.68 In 2004, the Supreme
+Court avoided deciding whether Congress could pass a statute to prohibit or regulate
+the detention and interrogation of captured suspects, which the Administration had
+asserted would unconstitutionally interfere with core commander-in-chief powers,
+by finding that Congress had implicitly authorized the detention of enemy
+combatants when it authorized the use of force in the aftermath of the September 11,
+2001, terrorist attacks.69 However, the Supreme Court in 2006 invalidated President
+Bush’s military order authorizing trials of aliens accused of terrorist offenses by
+military commission, finding that the regulations promulgated to implement the order
+did not comply with relevant statutes.70 The Court did not expressly pass on the
+constitutionality of any statute or discuss possible congressional incursion into areas
+of exclusive presidential authority, which was seen by many as implicitly confirming
+Congress’s authority to legislate in such a way as to limit the power of the
+Commander in Chief.71
+
+ II. Repeal of Prior Authorization to Use 
+
+ Military Force 
+
+While it is well-established that Congress and the President each possess
+
+authority on ending a military conflict, issues may arise if the political branches are
+in disagreement as to whether or how to end a military conflict. Inter-branch
+disagreement regarding the cessation of hostilities has been a rare occurrence, but it
+is not unprecedented. In the 110th Congress, a number of proposals have been
+introduced that would repeal or establish an expiration date for the Authorization for
+Use of Military Force against Iraq Resolution of 2002.72 The following sections
+
+68 See, e.g. Oversight of the Department of Justice: Hearing Before the Senate Judiciary
+Committee , 107th Cong. (2002) (testimony of Attorney General John Ashcroft)(arguing that
+Congress has no constitutional authority to interfere with the President’s decision to detain
+enemy combatants); see also Reid Skibell , Separation-of-Powers and the Commander in
+Chief — Congress’s Authority to Override Presidential Decisions in Crisis Situations , 13
+GEO. MASON L. REV. 183 (2004)(documenting Bush Administration claims with respect to
+Congress’s lack of power to legislate in matters related to the conduct of the war and
+arguing that these represent an expansion over prior administrations’ claims).
+
+69 See Hamdi v. Rumsfeld, 542 U.S. 507, 517 (2004).
+
+70 Hamdan v. Rumsfeld, 126 S.Ct. 2749 (2006).
+
+71 The Court adopted Chief Justice Chase’s formulation for allocating war powers, see id.
+ at 2773, and Justice Jackson’s framework for determining separation-of-powers disputes
+between the President and Congress, see id . at 2774 n.24 (“Whether or not the President has
+independent power, absent congressional authorization, to convene military commissions,
+he may not disregard limitations that Congress has, in proper exercise of its own war
+powers, placed on his powers. The Government does not argue otherwise.”)(citation
+omitted).
+
+72 See H.R. 1460 (repealing 2002 resolution); H.R. 1262 (same); S. 679 (declaring that
+objectives of 2002 resolution have been achieved, and requiring redeployment of forces
+from Iraq); S.J. Res. 3 (establishing expiration date for 2002 resolution); S. 670 (requiring
+
+(continued...)
+
+ 
+ CRS-17
+
+discuss the constitutional authority implicated by a repeal of military authorization,
+procedural, and other considerations involved in rescinding prior military
+authorization as compared to limiting appropriations, and the legal effect that a repeal
+would have on continuing hostilities.
+
+ Historical Practice 
+
+Although the U.S. Constitution expressly empowers Congress to declare war,
+
+it is notably silent regarding which political body is responsible for returning the
+United States to a state of peace. Some evidence suggests that this omission was not
+accidental.73 During the Constitutional Convention, a motion was made by one of
+the delegates to modify the draft document by adding the words “and peace” after the
+words “to declare war.”74 This motion, however, was unanimously rejected.
+Convention records do not clearly evidence the framers’ intent in rejecting the
+motion. 
+
+Some early constitutional commentators suggested that the motion failed
+
+because the framers believed that the power to make peace more naturally belonged
+to the treaty-making body, as conflicts between nations were typically resolved
+through treaties of peace.75 Although the framers did not specifically empower
+Congress to make peace, they also did not expressly locate the power with the treaty-
+making body, perhaps because of a recognition that peace might sometimes be more
+easily achieved through means other than treaty.76 
+
+72 (...continued)
+new military authorization unless certain objectives are met); H.R. 930 (repealing 2002
+resolution); H.R. 508 (same); H.R. 413 (same).
+
+73 Up to that point, the shared American and English tradition suggested that the institution
+with the power to instigate war was also the body with the power to end it. Blackstone
+believed that under the English system, “wherever the right resides of beginning a national
+war, there also must reside the right of ending it, or the power of making peace.” 1 WILLIAM
+BLACKSTONE, COMMENTARIES ON THE LAWS OF ENGLAND 250 (1756). When America
+declared its independence, it also rejected the monarchial form of government.
+Nevertheless, the legal document that the Constitution was intended to replace, the Articles
+of Confederation, expressly accorded the national legislative body with “the sole and
+exclusive right and power of determining on peace and war.” ARTICLES OF CONFEDERATION,
+art. IX, § 1. Under the Articles, there was neither a national executive nor judicial body.
+
+74 FARRAND, supra note 17, at 319; see also 3 JAMES MADISON, THE PAPERS OF JAMES
+MADISON 1352 (Henry Gilpin, ed. 1840).
+
+75 3 JOSEPH STORY, COMMENTARIES ON THE CONSTITUTION § 1173 (1833); WILLIAM
+RAWLE, A VIEW OF THE CONSTITUTION OF THE UNITED STATES, 110-111 (2nd ed. 1929). It
+should be noted that at the time the proposal was rejected, the framers had designated the
+Senate as the treaty-making body. The President was made part of the treaty-making body
+several weeks later. FARRAND, supra note 17, at 538.
+
+76 As a practical matter, a requirement that peace be achieved through a treaty between the
+warring parties would, in certain circumstances, lead to odd results: 
+
+The President, who is the Commander-in-Chief...and a majority of both branches
+of Congress, which declares war and maintains the forces necessary for its
+
+(continued...)
+
+ 
+ CRS-18
+
+It has been suggested that the framers did not allocate an exclusive body with
+
+peace-making authority because they believed “it should be more easy to get out of
+a war than into it.”77 Given the framers’ failure to designate a single political branch
+responsible for returning the country from a state of war to a state of peace, the power
+to make peace was likely understood to be a shared power, with each branch having
+the authority on terminating a military conflict.78 The executive could return the
+country to a state of peace through a treaty with the warring party, subject to the
+Senate’s advice and consent. Congress could declare peace or rescind a previous
+authorization to use military force pursuant to its plenary authority to repeal prior
+enactments, its power to regulate commerce with foreign nations, or its power to
+make laws “necessary and proper” to effectuate its constitutional powers.79 
+
+Regardless of the framers’ intent, the legislative and executive branches have
+
+historically treated peace-making as a shared power. Peace has been declared in one
+of three ways: (1) via legislation terminating a conflict, (2) pursuant to a treaty
+negotiated and signed by the executive and ratified following the advice and consent
+of the Senate, and (3) through a presidential proclamation.80 All three methods have
+been recognized as constitutionally legitimate by the Supreme Court,81 including
+most clearly in the 1948 case of Ludecke v. Watkins , where the Court plainly stated,
+“The state of war may be terminated by treaty or legislation or Presidential
+
+76 (...continued)
+
+prosecution, might desire peace yet be unable to obtain it because a third of the
+Senate plus one Senator were contrary minded. Or our erstwhile antagonist
+might be the contrary minded one. Or the war might have resulted in the
+extinction of said antagonist. Such, in fact, was the situation at the close of the
+Civil War, which accordingly could not be brought to an end in the legal sense
+by a treaty of peace.... 
+
+Edward S. Corwin, Power of Congress to Declare Peace , 18 MICH. L. REV. 669, 672-673
+(1920).
+
+77 Id. at 669. See also MADISON, supra note 74, at 1352 (quoting delegate Oliver Ellsworth
+in debate to give Congress the power to “make war”).
+
+78 See Corwin, supra note 76, at 673. 
+
+79 Id . at 674.
+
+80 A listing of all instances where the U.S. has formally declared war or authorized the use
+of military force, along with the date and means by which peace was declared or military
+authorization was terminated, can be found in CRS Report RL31133, Declarations of War
+and Authorizations for the Use of Military Force: Historical Background and Legal
+Implications , by Richard F. Grimmett and Jennifer K. Elsea.
+
+81 E.g. , Hijo v. United States, 194 U.S. 315 (1904) (recognizing state of war with Spain as
+ending with ratification of peace treaty); The Protector, 79 U.S. 700 (1871) (relying on
+presidential proclamations to determine the beginning and ending date of the Civil War);
+Commercial Trust v. Miller, 262 U.S. 51, 57 (1923) (recognizing congressional act as
+ending war with Germany). It should be noted that the Civil War is the only “war” which
+was ended by presidential proclamation. It could be argued that the methods by which the
+political branches may signal the termination of a domestic insurrection are different than
+those by which they may end a conflict with a foreign nation. 
+
+ 
+ CRS-19
+
+proclamation.”82 Notably, the Court has recognized that the termination of a military
+conflict is a “political act,”83 and it has historically refused to review the political
+branches’ determinations of when a conflict has officially ended.84
+
+ Rescinding Military Authorization Versus Cutting 
+Appropriations: Procedural and Other Considerations 
+
+As a procedural matter, it is more difficult for Congress to terminate
+
+authorization for a military conflict than to limit appropriations necessary for the
+continuation of hostilities. As in the case of ordinary legislation, congressional
+declarations of peace and rescissions of military authorization have historically taken
+the form of a bill or joint resolution passed by both Houses and presented to the
+President for signature.85 Like other legislation, such measures are subject to
+presidential veto, which Congress may override only with a two-thirds majority of
+each House.86
+
+In contrast, Congress’s ability to deny funds for the continuation of military
+
+hostilities is not contingent upon the enactment of a positive law, though such a
+denial may take the form of a positive enactment.87 Although the President has the
+power to veto legislative proposals, he cannot compel Congress to pass legislation,
+including bills to appropriate funds necessary for the continuation of a military
+
+82 335 U.S. 160, 168 (1948) (internal quotations omitted). There are potentially other ways
+in which peace could be made that were not contemplated by the Ludecke Court. See
+ CLINTON ROSSITER, THE SUPREME COURT AND THE COMMANDER IN CHIEF 79-80 (1970)
+(suggesting that a war could also be ended by, among other things, an executive agreement
+with or without specific congressional authorization).
+
+83 Ludecke , 335 U.S. at 168-169.
+
+84 Baker v. Carr, 369 U.S 186, 213-214 (1962) (describing the Court’s refusal to review the
+political branches’ determination of when or whether a war has ended). See generally
+ ROSSITER, supra note 82, at 83-89 (discussing Supreme Court jurisprudence upholding
+political branches’ determinations as to the official end of a war, including in cases where
+actual hostilities ceased several years beforehand).
+
+85 See CRS Report RL31133, Declarations of War and Authorizations for the Use of
+Military Force: Historical Background and Legal Implications , by Richard F. Grimmett and
+Jennifer K. Elsea; see also J. Gregory Sidak, To Declare War , 41 DUKE L.J. 27, 81-86
+(discussing historical operation of bicameralism and presentment in the war-making context,
+along with scholarly views concerning whether presentment is necessary).
+
+86 U.S. CONST., art. I, § 7, cl. (2)-(3).
+
+87 See, e.g., P.L. 91-652, § 7(a) (1971) (prohibiting funds appropriated from being used to
+introduce U.S. ground troops into Cambodia); P.L. 93-50, § 307 (1973) (prohibiting
+appropriated funds from being used in U.S. combat activities in Indochina after August15,
+1973) ; P.L. 103-139, § 8135 (1993) (barring appropriations from being used for combat
+forces in Somalia after March 31, 1994). For additional examples, see CRS Report
+RS20775, Congressional Use of Funding Cutoffs Since 1970 Involving U.S. Military Forces
+and Overseas Deployments , by Richard F. Grimmett, and CRS Report RL33803,
+ Congressional Restrictions on U.S. Military Operations in Vietnam, Cambodia, Laos,
+Somalia, and Kosovo: Funding and Non-Funding Approaches , by Amy Belasco, Lynn J.
+Cunningham, Hannah Fischer, and Larry A. Niksch.
+
+ 
+ CRS-20
+
+conflict. Thus, while a majority of both Houses would be necessary to terminate
+military authorization, and a super-majority of both Houses would be required to
+override a presidential veto, a simple majority of a single House could prevent the
+appropriation of funds necessary for the continuation of a military conflict. 88 It
+should be noted, however, that legislation probably would be required to prevent the
+President from exercising statutory authority to transfer certain funds appropriated
+to other operations for use in support of the military conflict that Congress was
+attempting to limit. Like other positive legislation, such a measure would be subject
+to presidential veto.
+
+While it may be procedurally easier for Congress to refuse appropriations for a
+
+military conflict than to rescind military authorization, policy considerations may
+sometimes make the latter option more appealing. For example, some Members of
+Congress who support the winding down of a military operation might nevertheless
+be reluctant to reduce the funds for troops on the battlefield. There might also be
+concerns over potential effects that a denial of appropriations might have on
+unrelated military operations. Although appropriations legislation can be crafted to
+effectively terminate hostilities while permitting funding of force protection measures
+during the orderly redeployment of troops from the battlefield, such legislation, like
+other positive enactments, would be subject to presidential veto. 
+
+In certain circumstances, a President may be more willing to agree to a
+
+rescission of military authorization than to an appropriations bill that limits the
+funding of military operations, particularly if the rescission does not include a
+deadline for troop withdrawal. Indeed, during the Vietnam War, Congress was able
+to rescind military authorization at an earlier date than it was able to cut off
+appropriations. In 1971, Congress passed and President Nixon signed a measure
+rescinding the 1964 Gulf of Tonkin resolution, which had provided congressional
+authorization for U.S. military operations against North Vietnam.89 The Mansfield
+Amendment, enacted later that year, called for the “prompt and orderly” withdrawal
+of U.S. troops from Indochina at the “earliest possible date.”90 However, these
+measures did not include a deadline for troop withdrawal. Although U.S. troop
+presence in South Vietnam diminished considerably pursuant to the Nixon
+Administration’s “Vietnamization” strategy even prior to these enactments, the
+United States continued significant air bombing campaigns in the years following the
+rescission of military authorization. During this same period, President Nixon vetoed
+or threatened to veto a number of appropriations bills that would have either
+prohibited funds from being used for certain military operations in Southeast Asia or
+required a complete withdrawal of U.S. troops from Vietnam. In 1973, two years
+after rescinding military authorization, Congress was finally able to enact
+appropriations limitations, signed by the President, that barred combat operations in
+Indochina.91 These appropriations measures were approved only after the signing
+
+88 See Sidak, supra note 85, at 104-105.
+
+89 P.L. 91-672, § 12 (1971).
+
+90 P.L. 92-156, § 601(a) (1971).
+
+91 E.g., P.L. 93-50, §§ 304-307 (1973) (preventing funding expenditures from being used
+
+(continued...)
+
+ 
+ CRS-21
+
+of a cease-fire agreement with North Vietnam and the withdrawal of U.S. troops from
+South Vietnam, and served primarily to end the aerial bombing campaign in
+Cambodia and prevent U.S. forces from being reintroduced into hostilities.
+
+In sum, in situations where Congress seeks to prevent the executive’s
+
+continuation of military combat operations, it may be procedurally easier for
+Congress to deny appropriations than it would be to statutorily compel a withdrawal
+from hostilities. However, past experience suggests that, at least in certain
+circumstances, policy considerations may cause the two branches to view the
+rescission of military authorization as a more appealing alternative — postponing an
+inter-branch conflict on appropriations for a later date, enabling Congress to signal
+its interest in winding down a conflict, and (at least temporarily) preserving the
+President’s discretion as to how the conflict is waged.
+
+ Legal Consequences of Congressional Rescission of Military
+Authorization, Absent Additional Congressional Action 
+
+Although Congress has the power to rescind authorization of a military conflict
+
+or enact a declaration of peace, the practical effect that such an action might have on
+the President’s ability to continue a military conflict may nevertheless remain
+difficult to predict. Historically, courts have been unwilling to interpret a
+congressional rescission of military authorization as barring the executive from
+continuing to wage a military campaign, at least so long as Congress continues to
+appropriate money in support of such operations . Although the War Powers
+Resolution establishes procedures by which Congress may direct the withdrawal of
+U.S. troops from military conflicts that lack statutory authorization, the
+constitutionality and practical effects of these requirements have been questioned.
+Finally, even in the absence of express congressional authorization, the President
+may possess some inherent or implied power as Commander in Chief to continue to
+engage in certain military operations. The following sections explain these points in
+greater detail.
+
+ Judicial Interpretation. Jurisprudence suggests that courts would not
+
+necessarily view a repeal of prior authorization, by itself, as compelling the
+immediate withdrawal of U.S. forces. As an overarching matter, courts have been
+highly reluctant to act in cases involving national security, especially when they
+require a pronouncement as to the legality of a military conflict or the strategies used
+therein.92 Many such cases have been dismissed without reaching the merits of the
+
+91 (...continued)
+“in or over . . . or off the shores of” Cambodia, Laos, North Vietnam and South Vietnam
+after August 15, 1973). For further background and examples of funding restrictions
+proposed and enacted, see CRS Report RS20775, Congressional Use of Funding Cutoffs
+Since 1970 Involving U.S. Military Forces and Overseas Deployments , by Richard F.
+Grimmett, and CRS Report RL33803, Congressional Restrictions on U.S. Military
+Operations in Vietnam, Cambodia, Laos, Somalia, and Kosovo: Funding and Non-Funding
+Approaches , by Amy Belasco, Lynn J. Cunningham, Hannah Fischer, and Larry A. Niksch.
+
+92 This is not to say that every legal challenge to a wartime activity is doomed to failure. In
+
+(continued...)
+
+ 
+ CRS-22
+
+arguments at issue, including when they involve a political question that the judiciary
+considers itself ill-suited to answer.93 Legal actions brought by Members of Congress
+challenging the lawfulness of military actions have had no greater success than suits
+brought by private citizens.94 While the courts have suggested a willingness to
+intervene in disputes between the two branches that reach a legal (as opposed to
+political) impasse, they have yet to find an impasse on matters of war that has
+required judicial settlement. In other words, as long as Congress retains options for
+bringing about a military disengagement but has not exercised them, courts are
+unlikely to get involved.95
+
+92 (...continued)
+some circumstances, the courts have found unlawful certain military activities involving the
+seizure of property or the detention of enemy combatants, at least in instances such action
+was deemed to lack sufficient congressional authorization. See, e.g., Little v. Barreme, 6
+U.S. (2 Cr.) 170 (1804) (upholding damage award to owners of U.S. merchant ship seized
+during quasi-war with France, when Congress had not authorized such seizures);
+Youngstown Sheet and Tube Co. v. Sawyer, 343 U.S. 579, 641 (1952) (finding unlawful the
+government seizure of property to settle labor dispute during Korean War); Rasul v. Bush,
+542 U.S. 466 (2004) (finding that federal habeas statute applied to persons detained in
+Guantanamo Bay pursuant to the “war on terror”); Hamdi v. Rumsfeld, 542 U.S. 507 (2004)
+(persons deemed “enemy combatants” in the “war on terror” have right to challenge
+detention before a neutral decision-maker); Hamdan v. Rumsfeld, 126 S.Ct. 2749 (2006)
+(finding that military tribunals convened by presidential order did not comply with the
+Uniform Code of Military Justice).
+
+93 In Baker v. Carr , 369 U.S. 186 (1962), the Supreme Court described situations where the
+political question doctrine was implicated:
+
+It is apparent that several formulations which vary slightly according to the
+settings in which the questions arise may describe a political question, although
+each has one or more elements which identify it as essentially a function of the
+separation of powers. Prominent on the surface of any case held to involve a
+political question is found a textually demonstrable constitutional commitment
+of the issue to a coordinate political department; or a lack of judicially
+discoverable and manageable standards for resolving it; or the impossibility of
+deciding without an initial policy determination of a kind clearly for nonjudicial
+discretion; or the impossibility of a court’s undertaking independent resolution
+without expressing lack of respect due coordinate branches of government; or an
+unusual need for unquestioning adherence to a political decision already made;
+or the potentiality of embarrassment from multifarious pronouncements by
+various departments on one question.
+
+ Id. at 217.
+
+94 For background and examples, see CRS Report RL30352, War Powers Litigation Initiated
+by Members of Congress Since the Enactment of the War Powers Resolution , by David. M.
+Ackerman. 
+
+95 See, e.g, Campbell v. Clinton, 52 F. Supp.2d 34 (D. D.C. 1999) (dismissing action seeking
+declaration that the President acted unlawfully in ordering air strikes in Kosovo and
+Yugoslavia without congressional authorization, because impasse had not been reached, as
+Congress had not barred introduction of U.S. forces or barred appropriations from being
+used for such purpose).
+
+ 
+ CRS-23
+
+The Vietnam conflict is the lone instance where Congress repealed military
+
+authorization while major combat operations were still ongoing. Although the Nixon
+Administration significantly decreased the number of U.S. troops present in South
+Vietnam following the repeal of the Gulf of Tonkin Resolution and enactment of the
+Mansfield Amendment in 1971,96 major combat operations continued into 1973,
+when Congress cut off all funding for military operations in Indochina. 
+
+During this period, federal courts heard a number of suits challenging the
+
+legality of continued hostilities in the absence of congressional authorization. None
+of these challenges proved successful, in large part because Congress continued to
+appropriate money for military operations. It is a well-established principle that
+Congress’s appropriation of funds may serve in some circumstances to confer
+authority for executive action.97 Reviewing courts have found this principle no less
+applicable concerning matters of war. The appropriation of billions of dollars in
+support of U.S. combat operations in Indochina, even after the repeal of the Gulf of
+Tonkin resolution, was viewed as congressional authorization for continued U.S.
+participation in hostilities,98 regardless of whether some Members of Congress had
+
+96 In a statement upon signing into law legislation containing the Mansfield Amendment,
+President Nixon claimed that its instructions were non-binding and pledged to continue his
+own policies for ending the war. Courts reached different conclusions as to the binding
+nature of the Mansfield Amendment’s instructions for withdrawal. In 1972, a district court
+in the Second Circuit concluded, in an opinion affirmed without opinion by the court of
+appeals, that the Amendment “had binding force and effect on every officer of the
+Government...[and] illegalized the pursuit of an inconsistent executive or administration
+policy.” DaCosta v. Nixon, 55 F.R.D. 145 (E.D.N.Y., 1972), aff’d without opinion , 456 F.2d
+1335 (2nd Cir. 1972). A year later, however, the Second Circuit Court of Appeals, while not
+deciding the issue, suggested that the binding nature of the Amendment was unsettled, and
+noted that “weighty constitutional considerations which support the President in his duties
+as Commander-in-Chief preclude too hasty an adoption of the view” that the Amendment
+was binding. DaCosta v. Laird, 471 F.2d 1146, 1156-1157 (2nd Cir. 1973).
+
+97 Fleming v. Mohawk Wrecking & Lumber Co., 331 U.S. 111, 116 (1947). See also Berk
+v. Laird 317 F. Supp. 715, 727-728 (D.C.N.Y. 1970) (discussing Supreme Court
+jurisprudence recognizing congressional appropriations as authorizing executive activity,
+and concluding that Congress’s appropriations for ongoing military operations in Indochina
+constituted authorization of those activities). Dept. of Justice, Office of Legal Counsel,
+2000 OLC LEXIS 16, Authorization for Continuing Hostilities in Kosovo (2000), at * 14-33
+(discussing judicial and scholarly recognition of appropriations statutes serving to authorize
+combat operations) [ hereinafter “OLC Opinion on Hostilities in Kosovo”].
+
+98 See DaCosta v. Laird, 448 F.2d 1368, 1369 (2nd Cir. 1971), cert. denied , 405 U.S. 979 (“In
+other words, there was sufficient legislative action in extending the Selective Service Act
+and in appropriating billions of dollars to carry on military and naval operations in Vietnam
+to ratify and approve the measures taken by the Executive, even in the absence of the Gulf
+of Tonkin Resolution.”); Orlando v. Laird, 443 F.2d 1039, 1043 (2nd Cir. 1971), cert. denied ,
+404 U.S. 869 (“The framers’ intent to vest the war power in Congress is in no way defeated
+by permitting an inference of authorization from legislative action furnishing the manpower
+and materials of war for the protracted military operation in Southeast Asia.”);
+Massachusetts v. Laird, 451 F.2d 26, 34 (1st Cir. 1971) (finding that Constitution had not
+been breached when President acted with support of Congress, including through the
+appropriation of billions of dollars to support ongoing combat operations); see also Berk
+
+(continued...)
+
+ 
+ CRS-24
+
+a motivation for approving continued appropriations other than that reflected in the
+express language of the enacted legislation.99 
+
+Courts have also declined on political question grounds to examine the motives
+
+of Congress in choosing to appropriate funds after rescinding direct authorization for
+U.S. military activities.100 In the words of one court, any attempt to assess Congress’s
+intentions in appropriating funds, and determining whether such appropriations were
+truly meant to further continuing hostilities, would necessarily “require the
+interrogation of members of Congress regarding what they intended by their votes,
+and then synthesization of the various answers. To do otherwise would call for gross
+speculation in a delicate matter pertaining to foreign relations.”101 Such an
+examination of Congress’s motivations was deemed beyond the scope of appropriate
+judicial scrutiny.102
+
+Some argued that Congress’s termination of statutory authorization for ongoing
+
+hostilities and instruction that the conflict end at the soonest practical date barred the
+President, at the very least, from “escalating” hostilities. Though the Court of
+Appeals for the Second Circuit suggested in a 1971 case that this argument might be
+valid,103 subsequent rulings indicated that the court would only be willing to consider
+this argument in very limited circumstances. Notably, in the 1973 case of DaCosta
+v. Laird ,104 the Second Circuit Court of Appeals dismissed a challenge to the
+President’s order to mine the harbors of North Vietnam, where it was argued that this
+order represented an unlawful escalation of hostilities in light of congressional
+
+98 (...continued)
+v. Laird, 317 F. Supp. 715 (E.D.N.Y.1970) (decided prior to repeal of Gulf of Tonkin
+resolution, but recognizing that continued appropriation of funds as authorization of
+conflict’s continuation).
+
+99 See Holtzman v. Schlesinger, 484 F.2d 1307, 1313-1314 (2nd Cir. 1973), cert. denied , 416
+U.S. 936 (1974) (finding appropriations legislation gave President sufficient authority to
+order the bombing of Cambodia, despite claim by some Members of Congress that
+legislation was “coerced” by presidential veto of appropriations bills that would have
+immediately cut off funding of such acts); Drinan v. Nixon, 364 F. Supp. 854 (D.C.Mass.
+1973) (same). 
+
+100 Orlando , 443 F.2d at 1043 (the decision to endorse military action through appropriations
+rather than direct authorization was “committed to the discretion of the Congress and
+outside the power and competency of the judiciary, because there are no intelligible and
+objectively manageable standards by which to judge such actions”); Sarnoff v. Connally,
+457 F.2d 809, 810 (9th Cir. 1972), cert. denied , 409 U.S. 929 (“Whether a plaintiff
+challenges the selective service system or the foreign aid and appropriations aspects of
+congressional cooperation in the present conflict, he presents a political question which we
+decline to adjudicate.”); Berk , 317 F. Supp. at 728-729 (recognizing that method that
+Congress chooses to endorse or authorize action is a political question).
+
+101 Atlee v. Laird, 347 F.Supp. 689, 706 (D.C.Pa. 1972), aff’d without opinion , 411 U.S. 911
+(1973).
+
+102 Id. ; Holtzman , 484 F.2d at 1314 &n.4.
+
+103 DaCosta , 448 F.2d at 1370.
+
+104 DaCosta v. Laird, 471 F.2d 1146 (2nd Cir. 1973).
+
+ 
+ CRS-25
+
+enactments ordering the withdrawal of U.S. troops at the earliest practicable date.
+The circuit court dismissed this challenge because it raised a nonjusticiable political
+question. Deciding such a case would require the court to assess the strategy and
+tactics used by the executive to wind down a conflict, an assessment it was ill-
+equipped to make:
+
+Judges, deficient in military knowledge, lacking vital information upon which to
+assess the nature of battlefield decisions, and sitting thousands of miles from the
+field of action, cannot reasonably determine whether a specific military operation
+constitutes an “escalation” of the war or is merely a new tactical approach within
+a continuing strategic plan. What if, for example, the war “de-escalates” so that
+it is waged as it was prior to the mining of North Vietnam’s harbors, and then
+“escalates” again? Are the courts required to oversee the conduct of the war on
+a daily basis, away from the scene of action? In this instance, it was the
+President’s view that the mining of North Vietnam’s harbor was necessary to
+preserve the lives of American soldiers in South Vietnam and to bring the war
+to a close. History will tell whether or not that assessment was correct, but
+without the benefit of such extended hindsight we are powerless to know.105
+
+Though the circuit court did not completely rule out the possibility that a further
+escalation of hostilities could be deemed unlawful, the court suggested it would be
+willing to consider such arguments only in the most limited of circumstances. For
+example, the court suggested that a “radical change in the character of war operations
+ — as by an intentional policy of indiscriminate bombing of civilians without any
+military objective — might be sufficiently measurable judicially to warrant a court’s
+consideration.”106
+
+In Holtzman v. Schlesinger , decided later that year, the Second Circuit Court of
+
+Appeals reversed a lower court decision that had declared unlawful the continued
+bombing of Cambodia following the removal of U.S. troops and prisoners of war
+from Vietnam. The circuit court held that it was a nonjusticiable political question
+as to whether the bombing violated the Mansfield Amendment’s instruction that
+hostilities be terminated at the “earliest practicable date.” Comparing the situation
+with that at issue in DaCosta , the court found that the challenge raised “precisely the
+questions of fact involving military and diplomatic expertise not vested in the
+judiciary.”107 Further, even assuming arguendo that the military and diplomatic
+issues raised by the bombing were judicially manageable, the circuit court found that
+Congress had authorized the bombing through continued appropriations.108
+
+105 Id. at 1155. 
+
+106 Id. at 1156 (italics added).
+
+107 Holtzman , 484 F.2d at 1309-1310 (2nd Cir. 1973), cert. denied , 416 U.S. 936 (1974).
+
+108 Id. at 1313. Specifically, the court noted the language of § 108 of the Joint Resolution
+Continuing Appropriations for Fiscal 1974, P.L. 93-52, which barred funding for military
+operations in and around Indochina after August 15, 1973. The Court inferred from this
+language that military activities at issue in the case before it, occurring before this deadline,
+were authorized.
+
+ 
+ CRS-26
+
+Taken together, these cases suggest that a reviewing court would probably not
+
+interpret a repeal of prior military authorization as requiring the immediate
+withdrawal of U.S. forces from ongoing hostilities in Iraq. Further, courts may be
+reluctant to assess whether specific military tactics or strategies pursued by the
+executive constitute an impermissible “escalation” of a conflict in the aftermath of
+such a repeal.109 Accordingly, it does not appear that the termination of direct
+authorization to use force, absent additional action such as the denial of
+appropriations or possibly the inclusion of an unambiguous deadline for troop
+withdrawal, would be interpreted by a reviewing court as constraining the executive’s
+ability to continue U.S. combat operations.
+
+ Implications of the War Powers Resolution. The consequences of a
+
+repeal of an authorization to use military force were arguably made more significant
+with the enactment of the War Powers Resolution (WPR).110 Enacted in 1973 over
+President Nixon’s veto, the WPR was an effort by Congress to reassert its role in
+matters of war — a role that many Members believed had been allowed to erode
+during the Korean and Vietnam conflicts. Among other things, the WPR establishes
+a procedure by which Congress may (theoretically) compel the President to withdraw
+U.S. forces from foreign-based conflicts when a declaration of war or authorization
+to use military force has been terminated. Specifically, WPR § 5(c) provides that
+
+at any time that United States Armed Forces are engaged in hostilities outside the
+territory of the United States, its possessions and territories without a declaration
+of war or specific statutory authorization, such forces shall be removed by the
+President if the Congress so directs by concurrent resolution.
+
+While § 5(c) offers a mechanism by which Congress might compel presidential
+
+compliance with a law that had rescinded statutory authorization to use military
+force,111 its constitutional validity is doubtful given the Supreme Court’s ruling in the
+1983 case of INS v. Chadha .112 In Chadha , the Court held that for a resolution to
+become a law, it must go through the bicameral and presentment process in its
+
+109 See, e.g. , Mottola v. Nixon, 318 F. Supp. 538, 540 (1970) (characterizing the extension
+of the conflict in Vietnam into Cambodia as a “necessary incidental, tactical incursion
+ordered by the Commander in Chief” that would be authorized so long as the military
+operations in Vietnam were found to be authorized), rev’d on other grounds , 464 F.2d 178
+(9th Cir. 1972)(ordering district court to dismiss for lack of standing).
+
+110 P.L. 93-148 (1973) [ hereinafter “War Powers Resolution” or “WPR”]. For further
+background and explanation of the War Powers Resolution, see CRS Report RL32267, The
+War Powers Resolution: After Thirty Years , by Richard F. Grimmett.
+
+111 The wording of the War Powers Resolution makes clear that appropriations in support
+of military operations does not in itself constitute “specific statutory authorization” of those
+operations for purposes of WPR requirements. See WPR § 8(a) (noting that authorization
+is not to be inferred from provisions “contained in any appropriation Act, unless such
+provision specifically authorizes the introduction of United States Armed Forces into
+hostilities ... [and states] that it is intended to constitute specific statutory authorization...”).
+
+112 462 U.S. 919 (1983).
+
+ 
+ CRS-27
+
+entirety.113 Accordingly, a concurrent or simple resolution could not be used as a
+“legislative veto” against executive action. Although the Chadha Court did not
+expressly find WPR § 5(c) to be unconstitutional, it was listed in Justice White’s
+dissent as one of nearly 200 legislative vetoes for which the majority had sounded the
+“death knell,”114 and most commentators have agreed with this assessment.115 Thus,
+it seems highly unlikely that the WPR could be used to enforce a congressional repeal
+of an authorization to use military force in Iraq.
+
+Section 5(b) of the WPR establishes a requirement for the withdrawal of U.S.
+
+troops 60 days after armed forces are introduced without congressional authorization
+into a situation where hostilities are imminent, unless Congress enacts legislation
+providing authority for the use of force or extends the deadline.116 This provision
+would not appear to supply a means by which Congress could compel the withdrawal
+of U.S. forces from Iraq, as the introduction of those forces was done pursuant to
+congressional authorization.117 Even if Congress were to rescind that authorization,
+the legality of actions taken pursuant to it would not be nullified.118 Arguably,
+
+113 Id. at 951.
+
+114 Id. at 967, 1003 (White, J., dissenting).
+
+115 See, e.g., Senate Foreign Relations Comm. Rep., Persian Gulf and the War Powers
+Resolution, S.Rept. No. 106, 100th Cong., 1st Sess., at 6 (1987) (describing § 5(c) as being
+“effectively nullified” by the Chadha decision); HENKIN, supra note 55, at 126-127
+(recognizing invalidation of § 5(c) by Chadha and describing arguments to the contrary as
+“plausible but not compelling”); WORMUTH AND FIRMAGE, supra note 13, at 222 (noting
+that the reasoning of Chadha “apparently invalidates secion 5(c) of the War Powers
+Resolution”); Ronald D. Rotunda, the War Powers Act in Perspective, 2 MICH. L. & POL’Y
+REV. 1, 8 (1997) (claiming that most “scholars have concluded that...[§ 5(c)] is
+unconstitutional ever since INS v. Chadha ). In contrast, some have argued that neither a
+declaration of war nor a subsequent rescission of authorization to use force constitutes an
+“ordinary” act of legislation falling under the requirements of the Presentment Clause. See
+ Stephen L. Carter, The Constitutionality of the War Powers Resolution , 70 VA. L. REV. 101,
+130-132 (1984). The legitimacy of this argument is untested and highly controversial, as
+Congress has always presented a declaration of war or authorization to use military force
+to the president. Further, even assuming arguendo that a declaration of war does not need
+to be presented to the President, it is not necessarily clear that legislation ending hostilities
+would also not require presentment. See HENKIN, supra note 55, at 127, 379; Carter, supra ,
+at 130-132 (describing weaknesses of argument against presentment requirement); see also
+ Sidak, supra note 85, at 84-85 (discussing historical and scholarly view that presentment is
+necessary).
+
+116 The requirement in § 5(b) does not apply in cases in which Congress “is physically
+unable to meet as a result of an armed attack upon the United States.” 50 U.S.C. § 1554.
+The 60-day deadline is automatically extended for thirty days “if the President determines
+and certifies to the Congress in writing that unavoidable military necessity respecting the
+safety of United States Armed Forces requires the continued use of such armed forces in the
+course of bringing about a prompt removal of such forces.”
+
+117 P.L. 107-243, § 5 (c) (“Congress declares that this section is intended to constitute
+specific authorization within the meaning of section 5(b) of the War Powers Resolution.”).
+
+118 See DaCosta , 448 F.2d at 1369 (the repeal of Gulf of Tonkin resolution “ did not wipe
+
+(continued...)
+
+ 
+ CRS-28
+
+however, a substantial increase in troop levels that takes place subsequent to any
+repeal of the authorization for use of military force against Iraq could trigger the
+requirements of WPR § 5(b),119 although it is unclear how large such an increase
+would need to be before it would be sufficiently “substantial.”120 Congress has in
+the past enacted or considered legislation declaring the 60-day limit to have taken
+effect, although apparently with little practical effect.121 In any case, it appears that
+WPR section 5(c), which permits Congress to compel the withdrawal of U.S. troops
+via concurrent resolution, was intended to address situations where Congress desired
+an end to previously authorized hostilities.
+
+ Inherent Presidential Authority to Use Military Force Absent 
+
+ Congressional Authorization. Even in the absence of express congressional
+authorization, it is well-recognized that the President may still employ military force
+in some circumstances pursuant to his powers as Commander in Chief and his
+inherent authority in the area of foreign affairs,122 at least so long as no statute stands
+in his way. A President would likely argue that this inherent authority would permit
+him to instruct U.S. forces to engage in certain military operations related to an
+ongoing conflict, even if statutory authorization for U.S. participation in that conflict
+had been rescinded. Further, even if Congress were to enact legislation requiring the
+cessation of military operations after a specified date, it is highly unlikely that this
+measure would be interpreted to prohibit any and all military operations, specifically
+
+118 (...continued)
+out its history nor could it have the effect of a nunc pro tunc action”).
+
+119 P.L. 93-148, §§ 4(a), 5(b). The reporting requirement in § 4(a), which begins the sixty-
+day withdrawal deadline, also comes into effect in the event troops are introduced in
+“numbers which substantially enlarge United States Armed Forces equipped for combat
+already located in a foreign nation.” However, it appears that the deadline only applies if
+the report was made necessary due to circumstances described in § 4(a)(1), where troops are
+initially introduced into hostilities. See MICHAEL J. GLENNON, CONSTITUTIONAL
+DIPLOMACY 103 (1990)(explaining that the omission of a requirement for the President to
+specify whether a report is submitted pursuant to § 4(a)(1) or § 4(a)(2) or (3) makes it
+impossible to know whether the sixty-day time period has been triggered). 
+
+120 In addition, it could be argued that even if Congress repealed the AUMF, the subsequent
+appropriation of funds in support of military operations would constitute legal authorization
+for such activity — at least in circumstances where Congress intended appropriations to
+support further hostilities, rather than simply to protect troops already in the field. See OLC
+Opinion on Hostilities in Kosovo, supra note 97, at * 33-52 (discussing instances in which
+appropriations suggest a clear intent by Congress to authorize further hostilities, and arguing
+that the WPR “ cannot be read to deny legal effect to...[the] clear intent” of Congress to use
+appropriations measures to authorize further hostilities).
+
+121 See GLENNON, supra note 119, at 104 (noting efforts with respect to Lebanon in 1983,
+P.L. 98-119, and Grenada, in which case no such final triggering legislation emerged,
+despite both Houses having passed measures to that effect). The necessity for separate
+legislation to trigger the triggering provision, subject as it is to presidential veto, seems to
+defeat the purpose for § 5(b). See id. at 105 (opining that the provision’s “central objective
+was to create a self-activating mechanism to control abuse of presidential discretion in the
+event Congress lacked the backbone to do so”).
+
+122 See supra at 9-15.
+
+ 
+ CRS-29
+
+as they relate to rescue and evacuation missions. It appears well-understood, at least
+as a matter of historical practice, that such missions are not intended to be covered
+under legislation otherwise barring future participation in hostilities.123 
+
+ III. Use of the Power of the Purse to Restrict 
+
+ Military Operations 
+
+Congress has used its spending power to restrict the deployment and use of the
+
+armed forces in the past.124 In 1973, for instance, after other legislative efforts failed
+to draw down U.S. participation in combat operations in Indochina,125 Congress
+effectively ended it by means of appropriations riders prohibiting use of funds.
+Section 307 of the Second Supplemental Appropriations Act for Fiscal Year 1973,
+P.L. 93-50 (1973), stated that, “None of the funds herein appropriated under this act
+may be expended to support directly or indirectly combat activities in or over
+Cambodia, Laos, North Vietnam, and South Vietnam, and after August 15, 1973, no
+other funds heretofore appropriated under any other act may be expended for such
+purpose.” Section 108 of the Continuing Appropriations Resolution for Fiscal Year
+1974, P.L. 93-52 (1973), provided that, “Notwithstanding any other provision of law,
+on or after August 15, 1973, no funds herein or heretofore appropriated may be
+obligated or expended to finance directly or indirectly combat activities by United
+States military forces in or over or from off the shores of North Vietnam, South
+Vietnam, Laos or Cambodia.” A year later, Congress passed an authorizing statute,
+section 38(f)(1) of the Foreign Assistance Act of 1974, P.L. 93-559 (1974), which set
+
+123 For example, even after Congress enacted legislation cutting off funding for all combat
+operations in Indochina, President Ford’s subsequent use of military forces to evacuate U.S.
+citizens and third country nationals was not seriously questioned, nor was a subsequent
+authorization of an operation to rescue the crew of the Mayaguez from Cambodian territory
+(a mission which was reported to Congress following the procedures of the War Powers
+Resolution, but only after the operation was completed). For background on congressional
+attitudes towards these rescue missions, see FISHER, supra note 11, at 157-158. See also
+ Rappenecker v. United States, 509 F.Supp. 1024, 1030 (D.C. Cal. 1980). The Rappenecker
+ case involved a civil suit by former crewmen of the Mayaguez for injuries they received
+during their rescue. Although the President ordered their rescue in the absence of prior
+congressional authorization, the Court assumed that the order was constitutionally valid.
+ Id. 
+
+124 For examples of such measures and a discussion of the context in which they were
+enacted, see CRS Report RS20775, Congressional Use of Funding Cutoffs Since 1970
+Involving U.S. Military Forces and Overseas Deployments , by Richard F. Grimmett, and
+CRS Report RL33803, Congressional Restrictions on U.S. Military Operations in Vietnam,
+Cambodia, Laos, Somalia, and Kosovo: Funding and Non-Funding Approaches , by Amy
+Belasco, Lynn J. Cunningham, Hannah G. Fischer, and Larry A. Niksch. See also, e.g. ,
+Louis Fisher, How Tightly Can Congress Draw the Purse Strings? , 83 AM.J.INT’L. L. 758
+(1989), and Tiefer , supra note 4.
+
+125 See P.L. 91-672, § 12, 84 Stat. 2053 (repealing Gulf of Tonkin Resolution); P.L. 92-156,
+§ 601(a), 85 Stat. 423, 430 (Mansfield Amendment); see also P.L. 92-156, § 501(a), 85 Stat.
+423, 427 (1971) (Fullbright proviso).
+
+ 
+ CRS-30
+
+a total ceiling of U.S. civilian and military personnel in Vietnam of 4,000 six months
+after enactment and a total ceiling of 3,000 within one year of enactment.
+
+A provision of an authorization act, section 404 of the International Security
+
+Assistance and Arms Export Control Act of 1976, P.L. 94-329 (1976),
+comprehensively prohibited using funds for military and paramilitary operations in
+Angola. It stated that:
+
+Notwithstanding any other provision of law, no assistance of any kind may be
+provided for the purpose, or which would have the effect, of promoting,
+augmenting, directly or indirectly, the capacity of any nation, group,
+organization, movement, or individual to conduct military or paramilitary
+operations in Angola, unless and until Congress expressly authorizes such
+assistance by law enacted after the date of enactment of this section.
+
+This section added that if the President determined that the prohibited assistance
+
+to Angola should be furnished, he should submit to the Speaker of the House and the
+Senate Committee on Foreign Relations a report describing recommended amounts
+and categories of assistance to be provided and identities of proposed aid recipients.
+This report also was to include a certification of his determination that furnishing
+such assistance was important to U.S. national security interests and an unclassified
+detailed statement of reasons supporting it.
+
+Section 109 of the Foreign Assistance and Related Programs Appropriations Act
+
+for Fiscal Year 1976, P.L. 94-330 (1976), signed the same day as P.L. 94-329,
+provided that, “None of the funds appropriated or made available pursuant to this act
+shall be obligated to finance directly or indirectly any type of military assistance to
+Angola.”
+
+In the 1980s, various versions of the Boland Amendment were enacted to
+
+prohibit using funds for various military activities in or around Nicaragua.126 For
+example, section 8066 of the Department of Defense Appropriations Act included in
+the Continuing Appropriations Resolution for Fiscal Year, 1985, P.L. 98-473, 98
+Stat. 1935 (1984), for example, stated that “During Fiscal Year 1985, no funds
+available to the Central Intelligence Agency, the Department of Defense, or any other
+agency or entity of the United States involved in intelligence activities may be
+obligated or expended for the purpose, or which would have the effect of supporting,
+indirectly or indirectly, military or paramilitary operation in Nicaragua by any nation,
+group, organization, movement or individual.” This provision stated that after
+February 28, 1985, the President could expend $14 million in funds if the President
+made a report to Congress which specified certain criteria, including the need to
+provide further assistance for military or paramilitary operations prohibited by the
+Boland Amendment, and if Congress passed a joint resolution approving such action.
+
+In the 1990s, Congress enacted section 8151 of the DOD Appropriations Act for
+
+Fiscal Year 1994, P.L. 103-139 (1993), which approved using armed forces for
+certain purposes including combat in a security role to protect United Nations units
+
+126 E.g., P.L. 98-473, § 8066, 98 Stat. 1904, 1935 (1984); see 133 Cong Rec. 15664-15701
+(June 15, 1987) (detailing various forms of the Boland Amendment that were enacted). 
+
+ 
+ CRS-31
+
+in Somalia, but cut off funding after March 31, 1994, except for a limited number of
+military troops to protect American diplomatic personnel and American citizens
+unless further authorized by Congress. Section 8135 of the DOD Appropriations Act
+for Fiscal Year 1995, P.L. 103-335 (1994), provided that, “None of the funds
+appropriated in this act may be used for the continuous presence in Somalia of United
+States military personnel, except for the protection of United States personnel, after
+September 30, 1994.” In title IX of the DOD Appropriations Act for Fiscal Year
+1995, P.L. 103-335 (1994), Congress provided that, “No funds provided in this act
+are available for United States military participation to continue Operation Support
+Hope in or around Rwanda after October 7, 1994, except for any action that is
+necessary to protect the lives of United States citizens.”
+
+These examples reveal the approaches that Congress has employed to prohibit
+
+or restrict using military force. They have ranged from the least comprehensive
+“none of the funds appropriated in this act may be used” to the most comprehensive
+“notwithstanding any other provision of law, no funds may be used.” The phrase
+“none of the funds appropriated in this act” limits only funds appropriated and made
+available in the act that carries the restriction, but not funds, if any, that may be
+available pursuant to other appropriations acts or authorizing statutes. To restrict
+funds appropriated and made available not only in the act that carries the restriction,
+but also pursuant to other appropriations acts, Congress has used the phrase “none
+of the funds appropriated in this act or any other act may be used.” The most
+comprehensive restriction is “notwithstanding any other provision of law, no funds
+may be used.” This language precludes using funds that have been appropriated in
+any appropriations acts as well as any funds that may be made available pursuant to
+any authorizing statutes including laws that authorize transfers of appropriated or
+nonappropriated funds.127 
+
+ Procedural Considerations 
+
+There is a parliamentary impediment to including the phrases “none of the funds
+
+appropriated in this act or any other act may be used” or “notwithstanding any other
+provision of law, no funds may be used” in a general appropriations bill. House Rule
+XXI, clause 2, makes subject to a point of order language that changes existing law
+(i.e., legislation) in a general appropriations bill (i.e., one providing appropriations
+for several agencies). A bill that appropriates funds for a single purpose or a single
+agency is not a general appropriations bill to which this restriction applies. The
+intent of Rule XXI, clause 2 is to separate the authorizing and appropriating functions
+and place them in separate committees.
+
+127 See, e.g. , 31 U.S.C. chap. 15, subchap. III “Transfers and Reimbursements” for provisions
+that authorize transfers of funds, including the Economy Act, 31 U.S.C. §§ 1535 and 1536,
+which allows an agency to transfer funds to another agency if the receiving agency can
+provide or get by contract goods or services less expensively or more conveniently than the
+ordering agency can get goods or services by a contract with a commercial enterprise.
+Transfer authority also is included in some other provisions of the United States Code that
+apply to individual departments and agencies and sometimes in appropriations acts. 
+
+ 
+ CRS-32
+
+Nonetheless, a practice has developed that just as the House may decline to
+
+appropriate funds for a purpose that has been authorized by law, it may by limitation
+prohibit appropriating money in a general appropriations bill for part of a purpose
+while appropriating funds for the remainder of it. Such a limitation “... may apply
+solely to the money of the appropriation under consideration” and “... may not apply
+to money appropriated in other acts.”128 Thus, the phrase “none of the funds
+appropriated in this act may be used” is not subject to a point of order, but the phrase
+“none of the funds appropriated in this act or any other act may be used” and the
+phrase “notwithstanding any other provision of law, no funds may be used” do not
+appear to qualify as permissible limitations in a general appropriations bill and would
+be subject to points of order under Rule XXI, clause 2 because they are considered
+legislation. To avoid a point of order, a limitation in a general appropriations bill
+may not impose new or additional duties on an executive official, may not restrict
+authority to incur obligations, and may not make an appropriation contingent upon
+(i.e., “unless” or “until”) the occurrence of an event not required by law.129 If a
+Member raises a point of order that language in a general appropriations bill violates
+Rule XXI, clause 2, and the point of order is sustained by the chair, the legislative
+language is stricken.
+
+Although legislation in a general appropriations bill is subject to a point of order
+
+under Rule XXI, clause 2, a restriction in a House rule is not self-enforcing.
+Consequently, legislation may be included in a general appropriations bill and
+become law if no point of order is raised, if a point of order is overruled, or if the
+House either suspends the rules or agrees to a special order known as a rule reported
+from the Committee on Rules that waives the point of order against including such
+legislation.130
+
+Like House Rule XXI, clause 2, Senate Standing Rule XVI also prohibits
+
+including legislation in a general appropriations bill, but the Senate rule permits
+legislation to be included if it is germane to the subject matter of the bill under
+consideration. If a point of order that language constitutes legislation on an
+appropriations bill is raised, the proponent of the language may defend it by asserting
+that it is germane. The question of germaneness is not decided by the presiding
+officer; it is submitted to the Senate. If a majority of Senators vote that the language
+in question is germane, it remains in the bill and the point of order that it constitutes
+legislation is dismissed and is not presented to the presiding officer for a ruling. If
+a majority of the Senate votes that language is not germane, the presiding officer then
+rules on whether it constitutes legislation. If the point of order is sustained, the
+language is removed; if it is overruled, the language remains in the bill and can be
+enacted.131
+
+128 See John V. Sullivan, House Parliamentarian, Constitution, Jefferson’s Manual, and
+Rules of the House of Representatives One Hundred Ninth Congress , H. DOC. 108-241, at
+§ 1053 (2005).
+
+129 See id . at §§ 1053-57 for an explanation of limitations.
+
+130 Id. at § 1058.
+
+131 Floyd M. Riddick, Senate Parliamentarian Emeritus, and Alan S. Frumin, Senate
+
+(continued...)
+
+ 
+ CRS-33
+
+As mentioned earlier, the intent of these House and Senate rules is to separate
+
+authorizing and appropriating functions by constraining the bodies from enacting
+legislation in appropriations bills, but prohibiting use of funds for a purpose or
+purposes does not contravene the House or Senate rule provided that the prohibition
+applies only to funds appropriated in the bill being considered.
+
+Because an appropriations act generally funds programs for a fiscal year, each
+
+provision contained in the act is presumed to be in effect only until the end of the
+fiscal year. “A provision contained in an annual appropriation act is not to be
+construed as permanent legislation unless the language used therein or the nature of
+the provision makes it clear that Congress intended it to be permanent. The
+presumption can be overcome if the provision uses language indicating futurity or if
+the provision is of a general character bearing no relation to the object of the
+appropriation.... The most common word of futurity is ‘hereafter’ and provisions
+using this term have often been construed to be permanent.”132 Other words of
+futurity include “after the date of approval of this act,”“henceforth,” and specific
+references to future fiscal years.133
+
+While including a word or words of futurity has the effect of making a provision
+
+extend beyond the fiscal year covered by an appropriations act, such a provision
+would constitute legislation that would appear to be subject to a point of order under
+House Rule XXI, clause 2 and Senate Standing Rule XVI during congressional
+consideration. If the parliamentary impediments can be overcome, however, such
+legislation may be enacted and become valid law.
+
+ Availability of Alternative Funds 
+
+A fundamental principle in appropriations law is that appropriations may not be
+
+augmented with funds from outside sources without statutory authority.
+
+As a general proposition, an agency may not augment its appropriations from
+outside sources without specific statutory authority. When Congress makes an
+appropriation, it also is establishing an authorized program level. In other words,
+it is telling the agency that it cannot operate beyond the level that it can finance
+under its appropriation. To permit an agency to operate beyond this level with
+funds derived from some other source without specific congressional sanction
+would amount to a usurpation of the congressional prerogative. Restated, the
+objective of the rule against augmentation of appropriations is to prevent a
+government agency from undercutting the congressional power of the purse by
+circuitously exceeding the amount Congress has appropriated for that activity.134
+
+131 (...continued)
+Parliamentarian, Riddick’s Senate Procedure: Precedents and Practices , S. DOC. 101-28,
+at 101 et seq. (1992). 
+
+132 GOVERNMENT ACCOUNTABILITY OFFICE, OFFICE OF GENERAL COUNSEL, I
+PRINCIPLES OF APPROPRIATIONS LAW 2-34 (3d ed. 2006) (footnotes omitted).
+
+133 Id. at 2-36.
+
+134 GOVERNMENT ACCOUNTABILITY OFFICE, OFFICE OF GENERAL COUNSEL, II PRINCIPLES
+
+(continued...)
+
+ 
+ CRS-34
+
+While no statute in precise terms expressly prohibits augmenting appropriations,
+
+the concept is based on some appropriations laws. The Miscellaneous Receipts
+Statute, 31 U.S.C. § 3302(b), requires that a government official who receives money
+for the government from any source must deposit it in the U.S. Treasury as soon as
+practicable without deduction for any charge or claim. Under the Purpose Statute,
+31 U.S.C. § 1301, appropriated funds may be used only for the purposes for which
+they are appropriated. A criminal provision, 18 U.S.C. § 209, prohibits
+supplementing the salary of an officer or employee of the government from any
+source other than the United States government.135
+
+An example of a statute permitting gift funds from other countries to finance a
+
+war is section 202 of the Continuing Resolution for Fiscal Year 1991, P.L. 101-403
+(1990), passed before the first Gulf war. Section 202 added a new section 2608 to
+title 10 of the United States Code to authorize any person, foreign government, or
+international organization to contribute money or real or personal property for use by
+the Department of Defense. However, before the Department of Defense could spend
+the funds, they had to be first appropriated by Congress.
+
+The Purpose Statute states that funds may be used only for purposes for which
+
+they have been appropriated; by implication it precludes using funds for purposes
+that Congress has prohibited. When Congress states that no funds may be used for
+a purpose, an agency would violate the Purpose Statute if it should use funds for that
+purpose; it also in some circumstances could contravene a provision of the
+Antideficiency Act, 31 U.S.C. § 1341. Section 1341 prohibits entering into
+obligations or expending funds in advance of or in excess of an amount appropriated
+unless authorized by law. If Congress has barred using funds for a purpose, entering
+into an obligation or expending any amount for it would violate the act by exceeding
+the amount — zero — that Congress has appropriated for the prohibited purpose.136
+
+To determine whether an agency has violated the Antideficiency Act, it would
+
+be necessary to review the language in an appropriations act or authorizing statute
+that includes a prohibition on using funds for a specific purpose. If an appropriations
+act prohibits using funds “in this act” for a purpose, for example, expending any
+amount from that act for the prohibited purpose would appear to contravene the
+Antideficiency Act because Congress has appropriated zero funds for it. Entering
+into obligations or expending funds, if any, that may be available from a different
+appropriations act or other fund for that purpose, however, would not appear to be
+prohibited by the Antideficiency Act; an agency would be able to use funds from
+sources other than the appropriations act that contains the prohibition or limitation.
+
+Violating the Antideficiency Act would be significant because it has notification
+
+and penalty provisions not found in the Purpose Statute. The Purpose Statute does
+not expressly provide for penalties; it generally is enforced by imposing
+
+134 (...continued)
+OF APPROPRIATIONS LAW, 6-162 (3d ed. 2006).
+
+135 Id. at 6-163.
+
+136 Id. at 6-62.
+
+ 
+ CRS-35
+
+administrative sanctions on the officer or employee who violates the statute.137 The
+Antideficiency Act, by contrast, contains a provision that not only provides for
+administrative discipline, including, when circumstances warrant, suspension from
+duty without pay or removal from office, 31 U.S.C. § 1349, but also one that requires
+an immediate report of a violation to the President and Congress, 31 U.S.C. § 1351.
+Moreover, the Antideficiency Act has a criminal penalty provision: Section 1350 of
+title 31 provides that an officer or employee who “knowingly and willfully” violates
+the act “shall be fined not more than $5,000, imprisoned for not more than two years,
+or both.” Although the act has a criminal provision, no one appears to have been
+prosecuted or convicted for violating it.138 Another criminal provision, 18 U.S.C. §
+435, not part of the Antideficiency Act, makes punishable by a fine of $1,000,
+imprisonment of not more than one year, or both, knowingly contracting to erect,
+repair, or furnish any public building or for any public improvement for an amount
+more than the amount appropriated for that purpose.
+
+The Antideficiency Act prohibits entering into obligations or expending funds
+
+in advance of or in excess of an amount appropriated unless authorized by law . One
+law that authorizes entering into obligations in advance of appropriations is the Feed
+and Forage Act. Also referred to as Revised Statute 3732, the Feed and Forage Act
+is part of and an express exception to the Adequacy of Appropriations Act, 41
+U.S.C. § 11. Section 11 generally states that no government contract or purchase
+may be made unless it is authorized by law or is under an appropriation adequate to
+its fulfillment. The Feed and Forage Act exception authorizes the Department of
+Defense and the Department of Transportation139 with respect to the Coast Guard
+when it is not operating as service in the Navy to make contracts in advance of
+appropriations for clothing, subsistence, forage, fuel, quarters, transportation, or
+medical and hospital supplies. Obligations entered into pursuant to Feed and Forage
+Act authority must not exceed the necessities of the current year. The Secretary of
+Defense and the Secretary of Transportation immediately must advise Congress of
+the exercise of this authority and report quarterly on the estimated obligations
+incurred pursuant to it.140 Although the Feed and Forage Act authorizes entering into
+obligations such as contracts, actual expenditures are not permitted pursuant to this
+authority until Congress appropriates the necessary funds.141
+
+137 Id. at 6-78.
+
+138 Id. at 6-141.
+
+139 6 U.S.C. § 468 transfers the Coast Guard to the Department of Homeland Security, but
+a corresponding change to 41 U.S.C. § 11 has not been enacted.
+
+140 See LOUIS FISHER, PRESIDENTIAL SPENDING POWER 238-247 (1975) for an explanation
+of the Feed and Forage Act.
+
+141 See Secretary of Defense (Comptroller), Budget Execution Flexibilities, Fiscal Year
+2005 (2004), available at [http://www.dod.mil/comptroller/execution/Final_Budget_
+Execution.pdf].
+
+ 
+ CRS-36
+
+ Redeployment from Iraq: 
+Provisions in the Vetoed Supplemental 
+
+On May 1, 2007, President George W. Bush vetoed the U.S. Troop Readiness,
+
+Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act, H.R.
+1591.142 In his veto message, the President said that the bill was objectionable
+because it would set an arbitrary date to begin withdrawing American forces from
+Iraq and would micromanage commanders in the field by restricting their ability to
+fight. He also objected to the inclusion of billions of dollars of spending and other
+provisions not related to the war. Finally, he asserted that the bill was
+unconstitutional because it “purport[ed] to direct the conduct of operations of war in
+a way that infringes upon the powers vested in the presidency by the Constitution,
+including as commander in chief of the Armed Forces.”143 The next day, the House
+of Representatives, by a vote of 222 to 203 — two-thirds not voting in the affirmative
+— failed to override the veto.144
+
+ Criteria Relating to Troops. Section 1901 of H.R. 1591, had it become law,
+
+would have provided that none of the funds appropriated or made available in the
+supplemental appropriations bill or in any other act could be used to deploy any
+armed forces unit unless the chief of the military department concerned certified in
+writing to the Committees on Appropriations and the Committees on Armed Services
+in advance of deployment that the unit was “fully mission capable” (i.e., “capable of
+performing assigned mission essential tasks to prescribed standards under the
+conditions expected in the theater of operations, consistent with the guidelines set
+forth in the Department of Defense readiness reporting system”). The President
+would have had the authority to waive the capability requirement on a unit-by-unit
+basis if he certified in writing to the appropriate committees that deploying a unit that
+is not fully mission-capable were required for reasons of national security and
+transmitted a report detailing the reason or reasons.
+
+Under section 1902, no funds appropriated or made available in the
+
+supplemental or in any other act would have been permitted to be obligated or
+expended to initiate developing, to continue developing, or to execute any order that
+would have the effect of extending the deployment of any Army, Army Reserve, or
+
+142 The House agreed to its version of H.R. 1591 by a vote of 218 to 212 on March 23, 2007.
+153 CONG. REC. H2999 (daily ed. March 23, 2007). On March 29, 2007, the Senate agreed
+to its version of H.R. 1591 by a vote of 51 to 47. 153 CONG. REC. S4093 (daily ed. March
+29, 2007). The House agreed to the conference report to accompany H.R. 1591 on April 25,
+2007, by a vote of 218 to 208. 153 CONG. REC. H4157-H4158 (daily ed. April 25, 2007).
+See 153 CONG. REC. H3823 (daily ed. April 24, 2007) for a reprint of the conference report,
+H.Rept. 110-107. The Senate agreed to the conference report on April 26, 2007, by a vote
+of 51 to 46. 153 CONG. REC. S5153 (daily ed. April 26, 2007). For a comprehensive
+discussion of H.R. 1591 and the status of followup legislation, see CRS Report RL33900,
+ FY2007 Supplemental Appropriations for Defense, Foreign Affairs, and Other Purposes ,
+by Stephen Daggett, Amy Belasco, Pat Towell, Susan B. Epstein, Connie Veillette, Curt
+Tarnoff, Rhoda Margesson, and Bart Elias.
+
+143 See 153 CONG. REC. H4315 (daily ed. May 2, 2007) for a reprint of the veto message.
+
+144 Id. at H4326. 
+
+ 
+ CRS-37
+
+Army National Guard unit beyond 365 days or of any Marine Corps or Marine Corps
+Reserve unit beyond 210 days. This limitation was not to be construed to require
+force levels in Iraq to be decreased below the total U.S. force levels in Iraq prior to
+January 10, 2007. The President would have had the authority to waive this
+limitation on a unit-by-unit basis by certifying in writing national security reasons
+and reporting details to the Committees on Appropriations and the Committees on
+Armed Services.
+
+Pursuant to section 1903, no funds in the supplemental or in any other act were
+
+to be available for deploying Army, Army Reserve, or Army National Guard units
+for Operation Iraqi Freedom if such unit had been deployed within the previous 365
+days, or for deploying any Marine Corps or Marine Corps Reserve unit if such unit
+had been deployed within the previous 210 days. This limitation was not to be
+construed to require force levels in Iraq to be decreased below the levels in that
+country prior to January 10, 2007. Like the limitations in sections 1901 and 1902,
+this one would have been subject to waiver by the President on a unit-by unit basis
+under the certification and notification procedures prescribed in the earlier
+limitations.
+
+ Benchmarks for Iraqi Government and Dates for Redeployment. 
+
+Section 1904 modified House and Senate language relating to Iraqi benchmarks and
+timetables. It would have required the President by July 1, 2007, to make and report
+to Congress determinations relating to progress that the government of Iraq is making
+in meeting benchmarks taken from the House and Senate bills. The President’s
+inability to make any of the determinations relating to the benchmarks was to have
+resulted in the commencement of troop redeployment from Iraq no later than July 1,
+2007, with a goal of completing redeployment within 180 days. If the President were
+able to make the determinations, the Secretary of Defense would have been required
+to commence redeploying forces from Iraq not later than October 1, 2007, with a goal
+of completing redeployment within 180 days. In either case, funds appropriated or
+otherwise made available in the bill or any other act were to be immediately available
+to plan and execute a safe and orderly redeployment of the Armed Forces from Iraq.
+
+Section 1904(a) of H.R. 1591 would have directed the President to determine
+
+and report findings to Congress on or before July 1, 2007, that relate to several
+matters including whether the Iraqi government — 
+
+! has given U.S. and Iraqi forces authority to pursue all extremists and
+
+is making substantial progress in delivering Iraqi forces to Baghdad
+and protecting them from political interference;
+
+! is making substantial progress in meeting its commitment to pursue
+
+reconciliation initiatives, including enacting a hydro-carbon law,
+adopting legislation for conducting provincial and local elections,
+reforming current laws governing the de-Baathification process,
+amending the Iraqi constitution, and allocating Iraqi revenues for
+reconstruction projects; 
+
+! is making, with U.S. armed forces, substantial progress in reducing
+
+the level of sectarian violence in Iraq; and
+
+ 
+ CRS-38
+
+! is ensuring the rights of minority political parties in the Iraqi
+
+Parliament are protected.
+
+Under section 1904(e), after the conclusion of the 180-day redeployment period
+
+specified above, the Secretary of Defense would not be permitted to deploy or
+maintain members of the U.S. armed forces for any purpose other than the following:
+
+! protecting American diplomatic facilities and American citizens,
+
+including U.S. armed forces;
+
+! serving in roles consistent with customary diplomatic positions;
+
+! engaging in targeted special actions limited in duration and scope to
+
+killing or capturing members of al-Qaeda and other terrorist
+organizations with global reach; or
+
+! training members of the Iraqi security forces.
+
+Section 1904(f) would have required that 50% of funds for assistance to Iraq
+
+under the headings “Economic Support Fund” and “International Narcotics Control
+and Law Enforcement” was to be withheld from obligation until the President had
+made a determination that the government of Iraq has met certain benchmarks.
+
+Finally, Section 1904(h) would have required that, beginning on September 1,
+
+2007, and every 60 days thereafter, the Commander of the Multi-National Forces,
+Iraq, and the U.S. Ambassador to Iraq were jointly to submit to Congress a report
+describing and assessing in detail the progress that the government of Iraq is making
+regarding benchmarks listed in section 1904(a).
+
+ Other Restrictions. Section 1311 would have prohibited the use of funds in
+
+the supplemental or in any other act to establish any military installation or base for
+the permanent stationing of U.S. military forces in Iraq or to exercise U.S. control
+over oil revenues in Iraq. Section 1312 would have denied authority to use funds in
+the supplemental to contravene several conventions and laws, including the United
+Nations Convention Against Torture and Other Cruel, Inhuman or Degrading
+Treatment or Punishment and 18 U.S. Code section 2340A. This limitation also
+applied to renditions. Section 1313 contained a requirement for the Secretary of
+Defense, within 30 days of enactment and every 90 days thereafter, to submit to the
+congressional defense committees a classified report assessing the individual
+transition readiness of units of Iraqi and Afghan security forces.
+
+ Provisions from the Enacted Supplemental, P.L. 110-28 
+
+The House and Senate agreed to H.R. 2206, the U.S. Troop Readiness,
+
+Veterans’ Care, Katrina Recovery, and Iraq Accountability Act Appropriations Act,
+P.L. 110-28, on May 24, 2007,145 and the President signed it on May 25. This act
+
+145 The House divided the question and held two votes; the first one on $10.8 billion in
+
+(continued...)
+
+ 
+ CRS-39
+
+provides supplemental funding through September 30, 2007, with no timetable for
+withdrawing troops. Section 1314 contains the major provisions relating to Iraq; it
+establishes 18 political and security benchmarks for the Iraqi government to meet.
+These benchmarks, similar to those that were included in the vetoed H.R. 1591,
+include enacting and implementing legislation on de-Baathification and on ensuring
+equitable distribution of hydrocarbon resources, increasing the number of Iraqi
+security forces units capable of operating independently, and allocating $10 billion
+in Iraqi revenues for reconstruction projects, including delivering essential services,
+on an equitable basis.
+
+The President is required to submit reports to Congress by July 15, 2007, and
+
+by September 15, 2007, on whether the Iraqi government is making sufficient
+progress in achieving these benchmarks. Obligation of reconstruction assistance to
+Iraq in the Economic Support Fund, about $1.6 billion, is prohibited unless the
+President certifies in both reports that Iraq is making progress on all the benchmarks
+or waives this requirement with a detailed rationale. The act requires an assessment
+of progress by the Iraqi government in meeting the benchmarks from the Government
+Accountability Office and an assessment of combat readiness of Iraqi security forces
+from an independent private sector entity selected by the Department of Defense. 
+
+P.L. 110-28 does not include criteria relating to United States forces including
+
+mission readiness, periods between deployments, and duration of deployments,
+which were a part of the vetoed H.R. 1591 and could have been waived on a unit-by-
+unit basis by the President for national security reasons.
+
+An earlier version of H.R. 2206, passed by the House, would have split the total
+
+amount into two portions. The first portion, about $47.6 billion, would have been
+available immediately to fund about two additional months of military operations.
+The second portion, about $53.2 billion, would have been available only if the
+President on or before July 13, 2007, submitted a report to Congress detailing
+progress of the Iraqi government in meeting political and security benchmarks,
+similar to those that were included in the vetoed H.R. 1591, and a joint resolution of
+approval was enacted into law.146 The Senate passed on May 17, 2007, a version of
+H.R. 2206 that expressed the sense of Congress in support of United States forces
+and requested a conference with the House.147 The House earlier rejected by a vote
+
+145 (...continued)
+congressional additions to the request by the Department of Defense passed by a vote of 348
+to 73, and the second one on $88.5 billion requested by DOD passed by a vote of 280 to 142.
+See 153 Cong. Rec. H5909-5911 (daily ed. May 25, 2007, which continued proceedings of
+May 24) for these votes and 153 Cong. Rec. H5776-H5800 and H5801-5805 (daily ed. May
+25, 2007) for the text of the first and second amendments, respectively. The Senate agreed
+to H.R. 2206 by a vote of 80 to 14. 153 Cong. Rec. S6823 (daily ed. May 24, 2007). 
+
+146 The House agreed to its May 10 version of H.R. 2206 by a vote of 221 to 205. See 153
+Cong. Rec. H4831-H4854 and H4866-H4867 (daily ed. May 11, 2007) for the text and vote
+on H.R. 2206, respectively.
+
+147 The Senate agreed to its May 17 version of H.R. 2206 by a vote of 94 to 1. See 153
+Cong. Rec. S6218-6219 (daily ed. May 17, 2007) for the text and vote on H.R. 2206,
+
+(continued...)
+
+ 
+ CRS-40
+
+of 171 to 255 H.R. 2337, a bill to require the Department of Defense to redeploy
+servicemembers and contractors from Iraq within 180 days.148 
+
+The rule reported by the Committee on Rules which provided for consideration
+
+of H.R. 2206 in the House of Representatives, H.Res. 486, 110th Cong., 1st Sess.,
+makes in order as an amendment the text of H.R. 2451, which requires withdrawing
+most United States forces from Iraq by June 28, 2008, when the House considers
+supplemental appropriations for military operations in Iraq or Afghanistan for
+FY2008.149 
+
+ IV. Limiting Deployment of Military Personnel 
+
+The Constitution accords Congress with ample authority to regulate the use of
+
+military personnel. Among other things, Congress is designated with the power “To
+raise and support Armies;” “To provide and maintain a Navy;” “To make Rules for
+the Government and Regulation of the land and naval Forces;” and “To provide for
+organizing, arming, and disciplining, the Militia, and for governing such Part of them
+as may be employed in the Service of the United States.”150 In the 110th Congress,
+several legislative proposals have been introduced that would limit the deployment
+of certain military personnel to Iraq.151 Some have argued that congressional action
+limiting the use of particular troops during wartime would, at least in certain
+circumstances, infringe upon the President’s authority as commander in chief to
+conduct a military campaign in a manner that he deems appropriate.152
+
+As a matter of historical practice, Congress has occasionally imposed limitations
+
+and other requirements on the deployment of U.S. troops, including during wartime.
+These limitations have been effectuated either through the statutory prohibition on
+the use of military personnel for a particular purpose, or via the denial of
+
+147 (...continued)
+respectively.
+
+148 See 153 Cong. Rec. H4796 and H4807 (daily ed. May 10, 2007) for the text and vote on
+H.R. 2337, respectively. 
+
+149 The House agreed to H.Res. 438 by a vote of 218 to 201. See 153 Cong. Rec. H 5730
+and 5748 for the text and vote on H.Res. 438, respectively.
+
+150 U.S. CONST. art. I, § 8.
+
+151 See, e.g., H.R. 1591 (as passed by both Houses and vetoed by the President) , §§ 1902-
+1903 (limiting deployment of U.S. troops to Iraq); S.Amdt. 2012 to H.R. 1585 (requiring
+minimum periods between deployment for units and members of the armed forces for
+Operation Iraqi Freedom and Operation Enduring Freedom); H.R. 1234 (barring funds from
+being appropriated for further deployment of U.S. military personnel to Iraq); S. 670
+(limiting funds for deployment of additional U.S. troops to Iraq unless Secretary of Defense
+certifies that troops are adequately trained and prepared).
+
+152 See Rivkin and Casey, supra note 4 (“Congress cannot, in other words, act as the
+president’s puppet master, and so long as currently authorized and appropriated funding
+lasts, the president can dispatch additional troops to Iraq with or without Congress’s
+blessing.”).
+
+ 
+ CRS-41
+
+appropriations in support of a particular operation. The following are examples in
+which Congress has limited the President’s ability to use particular military personnel
+for certain purposes:
+
+! 1915 — The Army appropriations act restricted Army tours of duty
+
+in the Philippines to two years and tours in the Canal Zone to three
+years, unless the servicemember requested otherwise or in cases of
+insurrection or actual or threatened hostilities.153 The restriction was
+amended in 1934 to provide for two-year tours and in both areas as
+well as certain other foreign duty stations.154 The restriction was
+repealed in 1945,155 and replaced with a requirement for the
+Secretary of Defense to report twice annually to the Armed Services
+committees regarding regulations governing the lengths of tours of
+duty for the Army and Air Force outside the continental United
+States.
+
+! 1933 — The Treasury and Post Office Appropriation Act for
+
+FY1934,156 provided that “Assignments of officers of the Army,
+Navy, or Marine Corps to permanent duty in the Philippines, on the
+Asiatic Station, or in China, Hawaii, Puerto Rico, or the Panama
+Canal Zone shall be for not less than three years. No such officer
+shall be transferred to duty in the continental United States before
+the expiration of such period unless the health of such officer or the
+public interest requires such transfer, and the reason for the transfer
+shall be stated in the order directing such transfer.” 
+
+! 1940 — The Selective Training and Service Act of 1940 provided
+
+that “Persons inducted into the land forces of the United States under
+this Act shall not be employed beyond the limits of the Western
+Hemisphere except in the Territories and possessions of the United
+States, including the Philippine Islands.”157
+
+! 1945 — In an act extending the Selective Training and Service Act
+
+until the end of World War II, as determined by the earlier of dates
+proclaimed by the President or by concurrent resolution by both
+Houses of Congress, provided that no inductee under the age of
+nineteen “shall be ordered into actual combat service until after he
+has been given at least six months of [appropriate] military
+training....”158
+
+153 38 Stat. 1078.
+
+154 P.L. 73-266, 48 Stat. 815, 816.
+
+155 P.L. 80-436, 62 Stat. 70-71.
+
+156 47 Stat. 1516, § 12.
+
+157 P.L. 76-783, § 3(e), 54 Stat. 885, 886.
+
+158 P.L. 79-54, § 2, 59 Stat. 166-67.
+
+ 
+ CRS-42
+
+! 1948 — The Selective Service Act of 1948 provided that eighteen-
+
+and nineteen-year old enlistees for one-year tours could not be
+assigned to land bases outside the continental United States.159
+
+! 1951 — 
+
+The Universal Military Training and Service Act of
+
+1951 required inductees, enlistees, and other persons called to active
+duty to receive at least four months’ “full and adequate” training
+prior to deployment overseas, and prohibited the expenditure of
+funds to transport or maintain a servicemember overseas in violation
+of the provision.160
+
+! 1956 — 10 U.S.C. § 6015 prohibited assignment of female
+
+servicemembers to duty on combat aircraft and all vessels of the
+Navy.161 10 U.S.C. § 6018 prohibited the assignment of Navy
+officers to shore duty not explicitly authorized by law.162 
+
+! 1985 — The National Defense Authorization Act, 1985 prohibited
+
+the expenditure of funds to support an end strength of U.S. Armed
+Forces personnel stationed in NATO countries above a level of
+326,414.163 The measure was later modified to reduce the level
+further but to provide waiver authority to the President to increase
+the force level to up to 311,855, upon notification to Congress, if he
+determined the national security interests required exceeding the
+ceiling.164 
+
+! 1992 — The National Defense Authorization Act for FY1992
+
+prohibited the use of appropriated funds to support an end strength
+level of members of the Armed Forces of the United States assigned
+to permanent duty ashore in nations outside the United States at any
+level in excess of 60 percent of the end strength level of such
+members on September 30, 1992, with exceptions in the event of
+declarations of war or emergency.165 
+
+The precise scope of Congress’s ability to limit the deployment of U.S. military
+
+forces has not been ruled upon by the courts, and it is therefore unclear whether
+legislative measures limiting the use of particular military personnel during wartime
+would ever be deemed to be an unconstitutional infringement upon the President’s
+
+159 P.L. 80-759, § 4(h), 62 Stat. 604, 608.
+
+160 P.L. 82-51, § 1(d), 65 Stat. 75, 78.
+
+161 70A Stat. 375-76.
+
+162 70A Stat. 376.
+
+163 98 P.L. 525, § 1002(c)(1), 98 Stat. 2575.
+
+164 P.L. 101-510, 104 Stat. 1546 (1990).
+
+165 P.L. 102-484, § 1302, 106 Stat. 2545. 
+
+ 
+ CRS-43
+
+authority as Commander in Chief.166 Nonetheless, historical practice suggests that,
+at least in some circumstances, Congress may oblige the President to comply with
+certain requirements on the deployment of particular military personnel, including
+during periods of armed conflict.
+
+ Analysis and Conclusion 
+
+Much of the historical debate over war powers has taken place in the context
+
+where a President has initiated the use of military force with ambiguous or no
+congressional authorization, which is not the case here. There is no obvious reason,
+however, to suppose that Congress’s constitutional power to limit hostilities depends
+on whether the hostilities were initiated with Congress’s express approval at the
+outset.167 Likewise, it does not seem consistent to suggest that Congress’s authority
+to limit the scope of hostilities may be exercised validly only at the initiation of
+hostilities, without opportunity for changing course once troops are engaged.
+
+In modern times, federal courts have been reticent to decide cases involving war
+
+powers on the merits,168 including those involving appropriations measures.169
+However, in discussing whether a particular challenge raises non-justiciable political
+questions involving matters textually committed to the political branches by the
+Constitution,170 courts have generally reiterated the understanding of a shared
+allocation of war powers.171 That is, it is generally agreed that Congress cannot
+
+166 For example, some have suggested that Congress could not bar the President from using
+military force to respond to a foreign invasion. See Sidak, supra note 85, at 51-55.
+
+167 See Tiefer, supra note 4, at 310-12 (outlining possible arguments for differentiating
+between authorized and unauthorized wars).
+
+168 See Jonathan L. Entin, The Dog That Rarely Barks: Why the Courts Won’t Resolve the
+War Powers Debate , 47 CASE W. RES. L. REV. 1305 (1997)(explaining paucity of court
+decisions regarding war powers). 
+
+169 See Stith, supra note 9, at 1387 (noting that courts have declined to enforce executive
+compliance with appropriations limitations, “particularly in areas where the Executive’s
+powers constitutional are significant”).
+
+170 Baker v. Carr, 369 U.S. 186, 211-12 (1962) (noting that justiciability of a foreign affairs
+matter is determined “in terms of the history of its management by the political branches,
+of its susceptibility to judicial handling in the light of its nature and posture in the specific
+case, and of the possible consequences of judicial action”); Powell v. McCormack, 395 U.S.
+486, 521 (1969)(making “a textually demonstrable constitutional commitment of the issue
+to a coordinate political department” the dominant factor for determining justiciability).
+
+171 Massachusetts v. Laird, 451 F.2d 26, 31-32 (1st Cir. 1971)(“The Congress may without
+executive cooperation declare war, thus triggering treaty obligations and domestic
+emergency powers. The executive may without Congressional participation repel attack,
+perhaps catapulting the country into a major conflict. But beyond these independent powers,
+each of which has its own rationale, the Constitutional scheme envisages the joint
+participation of the Congress and the executive in determining the scale and duration of
+hostilities.”). Another court found justiciable the question of whether military operations
+
+(continued...)
+
+ 
+ CRS-44
+
+“direct campaigns,” but that Congress can regulate the conduct of hostilities, at least
+to some degree, and that Congress can limit military operations without the risk of
+a presidential veto by refusing to appropriate funds.
+
+In 1970, in response to a challenge related to the Vietnam conflict, a federal
+
+district court172 expanded on the theme of congressional authority, with particular
+reference to Congress’s appropriations power:
+
+The power to commit American military forces under various sets of
+circumstances is shared by Congress and the Executive.... The Constitutional
+expression of this arrangement was not agreed upon by the Framers without
+considerable debate and compromise. A desire to facilitate the independent
+functioning of the Executive in foreign affairs and as commander-in-chief was
+tempered by a widely shared sentiment opposing the concentration of unchecked
+military power in the hands of the president. Thus, while the president was
+designated commander-in-chief of the armed forces, Congress was given the
+power to declare war. However, it would be shortsighted to view Art. I, § 8, cl.
+11 as the only limitation upon the Executive’s military powers.... [I]t is evident
+that the Founding Fathers envisioned congressional power to raise and support
+military forces as providing that body with an effective means of controlling
+presidential use thereof. Specifically, the House of Representatives ... was
+viewed by the Framers as the bulwark against encroachment by the other
+branches. In The Federalist No. 58 (Hamilton or Madison), we find:
+
+The House of Representatives cannot only refuse, but they alone can
+propose, the supplies requisite for the support of government. They,
+in a word, hold the purse — that powerful instrument by which we
+behold in the history of the British Constitution, an infant and humble
+representation of the people gradually enlarging the sphere of its
+activity and importance, and finally reducing, as far as it seems to
+have wished, all the overgrown prerogatives of the other branches of
+the government. This power over the purse may, in fact, be regarded
+as the most complete and effectual weapon with which any
+constitution can arm the immediate representatives of the people, for
+obtaining a redress of every grievance, and for carrying into effect
+every just and salutary measure.
+
+ 
+
+Despite Congress’s well-established authority over appropriations, it has been
+
+argued that the power of the purse cannot be wielded in such a way as to fetter the
+discretion of the Commander in Chief.173 Congress’s power of the purse is subject
+to the same constitutional restrictions as any other legislative enactment, including
+
+171 (...continued)
+were constitutional, proclaiming the test to be “whether there is any action by the Congress
+sufficient to authorize or ratify the military activity in question,” Orlando v. Laird, 443 F.2d
+1039 (2d Cir. 1971), cert. denied , 404 U.S. 869 (1971). The same court, however, found a
+determination of the effects of Congress’s repeal of the Gulf of Tonkin Resolution to be a
+non-justiciable political question. DaCosta v. Laird, 448 F.2d 1368 (2d Cir. 1971), cert.
+denied 405 U.S. 979 (1972).
+
+172 Davi v. Laird, 318 F.Supp. 478, 480 (W.D. Va. 1970).
+
+173 See Rivkin and Casey, supra note 4; see also Rosen, supra note 15, at 14-18 (outlining
+theories but questioning their validity).
+
+ 
+ CRS-45
+
+those that affect allocation of powers among the three branches.174 That is, Congress
+cannot use appropriations measures to achieve unconstitutional results, although it
+might, in some circumstances, achieve a similar result simply by failing to
+appropriate money.175 The doctrine of “unconstitutional conditions,” most frequently
+applicable to laws conditioning benefits for states or private citizens on their
+relinquishment of constitutional rights, is said to apply as well to legislation
+authorizing presidential action.176 This notion, however, adds little to the analysis.
+Congress has ample constitutional authority to enact legislation that restricts the
+scope of military operations. If Congress can enact a limitation on the conduct of
+military operations directly, it can do so through appropriations. The larger question
+remains whether the limitation enacted amounts to an unconstitutional usurpation of
+the actual conduct of war.
+
+Some commentators agree that Congress has the authority to cut off funds for
+
+military operations entirely, but assert that a partial cut-off or limitation on the use
+of funds would amount to an unconstitutional condition by interfering with the
+President’s authority to conduct battlefield operations.177 There has been some
+suggestion in the past that the President’s responsibility to provide for troops in the
+field justifies further deployments without prior authorization from Congress,178 with
+some arguing that the President has an independent implied spending power to carry
+
+174 Marbury v. Madison, 5 U.S. (1 Cr.) 137 (1803)(Congress may not enlarge the original
+jurisdiction of the Supreme Court); United States v. Klein, 80 U.S. (8 Wall.) 128 (1872)
+(Congress may not nullify effects of a presidential pardon or prescribe a rule of decision in
+a court case ); United States v. Lovett, 328 U.S. 303 (1946)(Congress may not create a bill
+of attainder by means of an appropriations measure denying money to pay salaries of named
+officials); Reid v. Covert, 354 U.S. 1 (1957)(Congress may not displace judicial role by
+subjecting civilians to military courts-martial during time of peace); INS v. Chadha, 462
+U.S. 919 (1983)(Congress may not invalidate executive decisions by one-house “legislative
+veto”).
+
+175 For example, in United States v. Klein , the Supreme Court invalidated a statute that
+prohibited the Court of Claims from receiving evidence of a presidential pardon in support
+of a claim against the government, finding the law interfered with the judicial power and the
+President’s pardon power. However, the Court upheld a statute that prohibited payment of
+the same claims out of the Treasury. Hart v. United States, 118 U.S. 62 (1886). Congress’s
+failure to appropriate funds for constitutionally mandated activities might itself be
+unconstitutional, but neither the courts nor the President would have the authority in such
+a case to mandate the expenditure of funds from the Treasury for the activity. See Stith,
+ supra note 9, at 1351.
+
+176 See, e.g., John Norton Moore, Do We Have an Imperial Congress? , 43 U. MIAMI L. REV.
+139, 145 & n25 (1988)(“Congress cannot condition funding or authority for the President
+to act in the foreign affairs arena upon the President’s surrender of his own constitutionally
+grounded duties and privileges.”).
+
+177 See Rivkin and Casey, supra note4 (“Under our constitutional system ... the power to cut
+off funding does not imply the authority to effect lesser restrictions, such as establishing
+benchmarks or other conditions on the president’s direction of the war.”).
+
+178 See Tiefer, supra note4, at 314-15 (describing the Nixon Administration’s legal rationale
+for expanding the Vietnam conflict into Cambodia and Laos).
+
+ 
+ CRS-46
+
+out these responsibilities.179 These arguments do not easily square with Congress’s
+established prerogative to limit the scope of wars through its war powers, and do not
+conform with Congress’s absolute authority to appropriate funds.
+
+Congress has frequently, although not invariably, acceded to presidential
+
+initiatives involving the use of military force. While a history of congressional
+acquiescence may create a gloss on the Constitutional allocation of powers,180 such
+a gloss will not necessarily withstand an express statutory mandate to the contrary.
+It does not appear that Congress has developed a sufficiently consistent or lengthy
+historical practice to have abandoned either its war power or its authority over
+appropriations. The executive branch has objected to legislative proposals it views
+as intrusive into presidential power, including conditions found in appropriations
+measures.181 And it remains possible to construe the function of “conducting military
+operations” broadly to find impermissible congressional interference in even the most
+mundane statutes regulating the armed forces. To date, however, no court has
+invalidated a statute passed by Congress on the basis that it impinges the
+constitutional authority of the Commander in Chief,182 whether directly or indirectly
+
+179 See Rosen, supra note 15, at 14-18 (summarizing theories).
+
+180 See Dames & Moore v. Regan, 453 U.S. 654 (1981) (executive agreements settling
+claims with Iran subsequent to the 1979-1981 hostage crisis held to be within President’s
+power, in part because of unbroken historical practice of Congress acceding to Presidential
+settlement of foreign claims by executive agreement).
+
+181 See H. Jefferson Powell, The President’s Authority over Foreign Affairs: An Executive
+Branch Perspective , 67 GEO. WASH. L. REV. 527, 565-75 (1999)(surveying historical
+examples of disagreements involving commander-in-chief powers).
+
+182 In one case, the Supreme Court agreed with the Court of Claims that a law passed
+pursuant to Congress’s authority to regulate the armed forces could not restrict a President’s
+commander-in-chief powers, and interpreted the statute accordingly. In Swaim v. United
+States , 165 U.S. 553 (1897), an officer challenged his court-martial on the grounds that it
+had been ordered by the President himself, where contemporary statute provided for the
+convening of courts-martial by certain commanders. The Court held the President had the
+inherent authority to convene courts-martial, citing with approval the legislative record
+describing the Articles of War as “not [intended] to exclude the inherent power residing in
+the president of the United States under the Constitution.” Id. at 557. The Senate
+Committee explained further 
+
+In this state of the history of legislation and practice, and in consideration of the
+nature of the office of commander in chief of the armies of the United States, the
+committee is of opinion that the acts of congress which have authorized the
+constitution of general courts-martial by an officer commanding an army,
+department, etc., are, instead of being restrictive of the power of the commander
+in chief, separate acts of legislation, and merely provide for the constitution of
+general courts-martial by officers subordinate to the commander in chief, and
+who, without such legislation, would not possess that power, and that they do not
+in any manner control or restrain the commander in chief of the army from
+exercising the power which the committee think, in the absence of legislation
+expressly prohibitive, resides in him from the very nature of his office, and
+which, as has been stated, has always been exercised.
+
+(continued...)
+
+ 
+ CRS-47
+
+through appropriations. In contrast, presidential assertions of authority based on the
+Commander-in-Chief Clause, in excess of or contrary to congressional authority,
+have been struck down by the courts.183
+
+On the other hand, Presidents have sometimes deemed such limitations to be
+
+unconstitutional or merely precatory, and have at times not given them the force of
+law.184 In other words, Administrations have relied on an argument based on the
+doctrine of “unconstitutional conditions” to justify the President’s authority to reject
+a limitation on national security spending while continuing to spend the funds.185
+Whether or not the President is constitutionally entitled to spend funds without
+adhering to relevant legislative conditions appears to be an issue unlikely to be
+resolved by the courts.
+
+In sum, it seems that under the constitutional allocation of powers Congress has
+
+the prerogative of placing a legally binding condition on the use of appropriations to
+regulate or end the deployment of U.S. armed forces to Iraq. Such a prohibition
+seems directly related to the allocation of resources at the President’s disposal, and
+would therefore not appear to interfere impermissibly with the President’s ability to
+exercise command and control over the U.S. armed forces. Although not beyond
+question, such a prohibition would arguably survive challenge as an incident both of
+Congress’s war power and of its power over appropriations.
+
+182 (...continued)
+ Id . at 557-58. Even recognizing the inherent power of the president to convene courts-
+martial, however, the Court proceeded to explore whether the Articles of War had been
+properly applied. The case appears to demonstrate that Congress may regulate the exercise
+of inherent commander-in-chief powers as long as it does not extinguish them completely.
+
+183 See Little v. Barreme, 6 U.S. (2 Cr.) 170 (1804); Ex parte Milligan, 71 U.S. (4 Wall.) 2
+(1866); Youngstown Sheet and Tube Co. v. Sawyer, 343 U.S. 579 (1952); Hamdan v.
+Rumsfeld, 126 S.Ct. 2749 (2006).
+
+184 See Powell , supra note 181, at 552-53. 
+
+185 See Tiefer, supra note 4, at 312 (providing examples of the “say no, but keep the dough”
+approach for circumventing appropriations limitations viewed as unconstitutional); Powell,
+ supra note 181, at 553 (describing executive branch formula for determining the effect on
+an appropriation of an invalid condition to be based on “whether Congress’s main purpose
+in enacting the appropriation was to create a means of forcing the congressional policy
+embodied in the condition on the President”).
\ No newline at end of file
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@@ -0,0 +1,92 @@
+Federal Debt and the Debt Limit in 2025 
+
+ 
+
+ Updated June 24, 2025
+ (IN12045)
+ 
+
+ 
+ The federal debt limit was reinstated on January 2, 2025, at $ 36. 1 trillion . On that date, debt held by the public totaled $28.8 trillion and intergovernmental accounts accounted for $7.3 trillion. The statutory debt limit constrains nearly all federal debt, including both debt held by the public (mostly Treasury securities sold via auctions) and intragovernmental debt (mainly federal trust funds, such as those for Social Security, Medicare, and federal retirement systems).
+
+ The Fiscal Responsibility Act of 2023 (FRA; P.L. 118-5 ), enacted on June 3, 2023, had suspended the debt limit until January 1, 2025. The FRA also reimposed statutory caps on discretionary spending; and rescinded unobligated funds from various federal accounts. The reestablished limit was set at a level to accommodate debt issued during the suspension period to fund federal operations. Since 2013, Congress has mostly resolved debt limit episodes by suspending the limit for a set period of time. In 2021, however, the limit was raised twice by specific dollar amounts.
+
+ On May 22, 2025, the House approved H.R. 1 on a 215-214 vote; among other provisions, the bill would raise the debt limit by $4 trillion. The Congressional Budget Office estimates that enacting the bill would increase deficits over the coming decade by $3.3 trillion.
+
+ The persistent gap between federal revenues and outlays over the past two decades has pushed up public debt levels to historic levels. Some of that gap stems from external shocks, especially the 2007-2009 financial crisis and ensuing Great Recession and the COVID-19 pandemic. Such shocks reduce revenues and lead to increased spending as household incomes fall . A fiscal gap, to a lesser extent, preceded those shocks and continued after them. Under current policies, that gap is projected to widen, pushing debt to historic levels.
+
+ Extraordinary Measures Anticipated to Begin Later in January 2025
+
+ After previous debt limit suspensions ended Treasury Secretaries immediately invoked authorities to use extraordinary measures . The Treasury Secretary has authority to declare a "debt issuance suspension period" (DISP) when deposits in the form of special Treasury securities into the Civil Service Retirement and Disability Fund (CSRDF) cannot be issued without exceeding the debt limit. During a DISP, the U.S. Treasury can use financial resources from civil service and postal service retirement funds to meet federal obligations. Delaying deposits into those funds or redeeming the Treasury securities they hold comprises the bulk of extraordinary measures. Other extraordinary measures include dollar holdings of the Exchange Stabilization Fund and the Thrift Savings Plan's (TSP's) holdings of Treasury securities. Treasury's cash balances (see below) may also be used to delay a binding debt limit.
+
+ In late December 2024, then-Treasury Secretary Janet Yellen wrote Congress that she expected extraordinary measures would soon become necessary. On January 17, 2025, she then informed Congress that the Treasury would begin employing those measures the following Monday. Two days later, the new Acting Treasury Secretary notified Congress that he had invoked authorities to use the TSP G Fund resources. In March 2025, Treasury Secretary Scott Bessent invoked authorities to use civil service and postal service retirement funds. In May 2025, he informed Congress that Treasury's resources could be exhausted in August, when Congress was scheduled to be in recess, and therefore urged prompt action to address the debt limit.
+
+ How long Treasury can continue to meet federal financial obligations depends on its cash balances, the extent of funds available via extraordinary measures, and the timing of federal revenues and payments—when taxes are collected and when outlays are paid—as well as the schedule of redemptions and interest payments to federal trust funds. In June 2025, CBO estimated that the Treasury could meet federal obligations until sometime between mid-August and late September 2025. Some informed observers believe the Treasury's resources might last as long as early October, although they note that projections of federal outlays and revenues are inexact. While Treasury now reports balances on funds used for extraordinary measures on a daily basis , which improves the precision of those projections, delayed action still could create serious risks. 
+
+ Public debt allows governments to spread costs over time , especially for major infrastructure investments or responses to natural disasters or geopolitical challenges. High debt levels can crowd out private investment and push the fiscal burdens onto future generations. 
+
+ Federal debt has risen considerably since FY2001, the last fiscal year in which the U.S. government ran a surplus . At the end of FY2001, gross federal debt stood at $5.8 trillion , about 55% of gross domestic product (GDP). At that time, debt held by the public was $3.3 trillion (about 32% of GDP), which included Federal Reserve holdings of Treasury debt (about $0.5 trillion, 5.1% of GDP).
+
+ COVID-19, declared a pandemic in mid-March 2020, confronted the federal government, like governments around the world, with extraordinary challenges. Fiscal responses to the pandemic accelerated the accumulation of federal debt. 
+
+ Major public works measures such as the Infrastructure Investment and Jobs Act and the Inflation Reduction Act have also affected the pace of federal borrowing, as has the 2017 tax act .
+
+ At the end of December 2024, total federal debt ($36.2 trillion) was about 123% of GDP and federal debt held by the public ($28.8 trillion)—the more relevant macroeconomic measure—was 98% of GDP . Most of the accumulation of total debt reflects increases in debt held by the public, rather than intergovernmental debt, as Figure 1 shows. 
+
+ Intragovernmental debt, which includes Social Security trust funds, Medicare trust funds, and various federal retirement trust funds, has risen more smoothly and more slowly. In particular, the closer balance between Social Security trust fund revenues and benefit outlays , largely due to the retirement of Baby Boom cohorts has slowed the growth of intergovernmental debt. 
+
+ In future decades, federal health and retirement programs are projected to pose longer-term budgetary challenges . The gap between federal outlays (a projected 23.5% of GDP in FY2025) and revenues ( projected at 17.0% of GDP ) is projected to grow, according to Congressional Budget Office current-law baseline projections. 
+
+ A long-term decline in interest rates beginning in the mid-1980s had mitigated debt service costs. Since the pandemic summer of 2020, however , interest rates increased, reaching about the same levels as before the start of the 2008 financial crisis. How long higher interest rates—which would add a projected $2.5 trillion in debt service costs over the next decade—might persist is an important macroeconomic question.
+
+ 
+
+ 
+ 
+ 
+ Figure 1. Federal Debt by Category, 2008-2025
+
+ Billions of current dollars; Debt limit increases in grey, suspensions in ochre
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: CRS calculations based on Daily Treasury Statement data.
+
+ Note: Debt held by the public includes open-market purchases by the Federal Reserve System.
+
+ 
+ 
+ 
+
+ Treasury Debt Management and the Federal Reserve
+
+ Treasury's cash balances, except during debt limit episodes, have been much higher than a decade ago ( Figure 2 ). Before the Lehman Brothers investment bank collapsed in September 2008, Treasury cash balances were kept to minimal levels. A 2015 Treasury advisory committee recommended increasing cash balances as a precaution against major disruptions. 
+
+ After the March 2020 COVID-19 pandemic declaration, Treasury's cash balances rose sharply to enable rapid disbursement of CARES Act ( P.L. 116-136 ) payments. Near the end of debt limit episodes in 2021 and 2023, cash balances dipped below $100 billion.
+
+ Debt held by the public includes the Federal Reserve System (Fed) open-market purchases of Treasury securities, used to support its monetary policy. During the 2007-2009 financial crisis, the Fed conducted nonstandard monetary policies , including buying amounts of Treasury securities. As the Fed s old off those assets , and with reduced liquidity in Treasury markets, some were concerned that a debt limit episode leading to a rapid reduction in Treasury cash balances could stress the wider market for Treasuries and work at cross purposes with Fed monetary policy. Those Fed sales slow ed slightly in 2025.
+
+ 
+
+ 
+ 
+ 
+ Figure 2. Treasury Cash Balances, FY2007-FY2025
+
+ Billions of current dollars
+
+ 
+ 
+ 
+ 
+ 
+ 
+ 
+ Source: CRS calculations based on Daily Treasury Statement data.
+
+ Note: Before 2010, Treasury kept smaller amounts of cash balances outside of the main Treasury General Fund Account held with the Federal Reserve.
\ No newline at end of file
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@@ -0,0 +1,1860 @@
+98-617 STM
+
+CRS Report for Congress
+
+Received through the CRS Web
+
+Technology, Trade, and Security Issues
+
+Between the United States and the People’s
+
+Republic of China: A Trip Report, August 1997 
+
+June 30, 1998
+
+(name redacted)
+
+Specialist in Technology and Telecommunications Policy
+
+Science, Technology, and Medicine Division
+
+ Congressional Research Service ˜ The Library of Congress 
+
+ 
+ ABSTRACT 
+
+This is a trip report based on discussions held with both Chinese and U.S. officials and
+business leaders in China during 1997. The CRS representative was part of a U.S.
+congressional staff delegation which visited Beijing, Xi’an, Shanghai, and Hong Kong.
+Discussions during the two weeks in China covered three major policy areas: technology,
+trade, and security. Developments since August 1997 indicate that these three areas
+continue to be subjects of great interest between the two nations. This report provides an
+analysis of both U.S. and Chinese perspectives on these issues at the time of the visit, and
+a brief update regarding issues since August 1997. It is part of a series of trip reports written
+by CRS analysts on southeast Asia. It will not be updated.
+
+ 
+ Technology, Trade, and Security Issues Between the United
+
+States and the People’s Republic of China: A Trip Report,
+
+August 1997 
+
+ Summary 
+
+From August 12th through August 20th, 1997, a congressional staff delegation
+
+visited the People’s Republic of China. This report provides the research findings
+of this group, which was sponsored by the U.S.-Asia Institute, and was the 37th such
+trip undertaken since 1979 to increase the understanding between the two nations.
+The U.S. group was comprised of seven congressional staff from the House of
+Representatives, the U.S. Senate, and the Congressional Research Service. The
+delegation met with Chinese industry and business leaders in Beijing, Xi’an,
+Shanghai, and Hong Kong. The group also met with several U.S. State Department
+officials and representatives of U.S. industry doing business in China. 
+
+The meetings focused on many policy issues. However, three themes emerged
+
+during the two weeks of discussions: technology, trade, and security issues between
+the two countries. Since August 1997, technology, trade, and security issues have
+become more prominent and perhaps more contentious. Several of the specific issues
+discussed, such as the trade imbalance between the United States and China (and the
+composition of that trade), China’s membership in the World Trade Organization
+(WTO) and Most Favored Nation (MFN) status with the United States, and human
+rights issues as a form of international diplomacy and relations, are still important
+concerns between the two nations
+
+In Beijing, discussions with Chinese officials, U.S. business representatives, and
+
+U.S. Department of State staff focused on overall technology, trade, and security
+issues between the two countries. These included the merchandise trade deficit that
+the United States has with China, the growth and trend of the deficit, China’s
+Membership in the World Trade Organization, Most Favored Nation status with the
+United States, and linking trade policy to non-trade issues, such as human rights.
+Discussions in Beijing also concerned technology transfer and proliferation issues
+between the two countries. In Xi’an, the political and cultural history of China put
+many of the PRC’s current issues into perspective. High technology development
+and agricultural trade issues were also discussed. In Shanghai, technology and
+capital formation, the roles of state-owned enterprises and multinational enterprises,
+and telecommunications and the growth of the Internet were topics of discussion. In
+Hong Kong, the turnover of the island from British to Chinese rule, political freedom,
+and territorial sovereignty issues were discussed.
+ 
+
+Technology, trade, and security issues continue to be important components of
+
+the relationship between the two countries. Important issues and developments since
+August 1997 have included President Jiang’s visit to the United States, an economic
+slowdown in Asia, a worsening trade balance between the two nations, technology
+transfer and proliferation issues, and President Clinton’s visit to China in June 1998.
+ 
+
+ 
+ Contents 
+
+Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
+
+Beijing (August 12th - 16th) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
+
+An Overview of Technology, Trade, and Security Issues . . . . . . . . . . . . . . . 2
+
+Trade Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
+Linking Trade to Other Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
+Technology and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
+
+Xi’an (August 15th - 17th) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
+
+High Technology Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
+Agriculture Exports and Sanitary Standards . . . . . . . . . . . . . . . . . . . . . . . . 13
+Political and Cultural History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
+
+Shanghai (August 18th - 21st) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
+
+Technology and Capital Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+SOEs and MNEs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
+Telecommunications and the Internet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
+
+Hong Kong (August 22nd and 23rd) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
+
+Hong Kong After July 1, 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
+Political Freedom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
+Territorial Sovereignty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
+
+Epilogue: Developments Since August 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
+
+References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
+
+ 
+ Technology, Trade, and Security Issues Between
+
+the United States and the People’s Republic of
+
+China: A Trip Report, August 1997
+
+ Background 
+
+This report provides research findings from a two week trip to the People’s
+
+Republic of China (PRC), August 12 to August 20, 1997.1 This trip was sponsored
+by the U.S.-Asia Institute, and was the 37th such trip undertaken as part of that
+organization’s efforts to expand the knowledge and understanding between the
+United States and China. The U.S. group was comprised of seven staff members
+from the House of Representatives, the U.S. Senate, and the Congressional Research
+Service. The delegation met with Chinese industry and business leaders in Beijing,
+Xi’an, Shanghai, and Hong Kong.2 The group also met with several U.S. State
+Department officials and representatives of U.S. industry doing business in China,
+to obtain their perspectives. The views and opinions expressed by members of the
+U.S. delegation reflected either their own perspectives or the perspectives of the
+Members of Congress they represented, and did not necessarily reflect official U.S.
+government policy. 
+
+The meetings focused on many policy issues. However, three themes emerged
+
+during the two weeks of discussions: technology, trade, and security issues between
+the two countries. Since August 1997, technology, trade, and security issues have
+become more prominent and some more contentious. Several of the specific issues
+discussed included the trade imbalance between the United States and China (and the
+composition of that trade), China’s membership in the World Trade Organization
+(WTO) and Most Favored Nation (MFN) status with the United States, and linking
+human rights issues to trade policy. 
+
+Other issues touched on during the two weeks of meetings last summer have
+
+since emerged as critical in Sino-American relations. These include technology
+transfer and U.S. export control policies, the financial health and economic growth
+of China and Hong Kong, and the delicate issue of foreign influence on domestic
+politics and policies. On several of these issues, concerns raised on both sides during
+the two weeks of meetings were addressed. As a result, a greater understanding of
+national policies was achieved on both sides. In other areas, concerns remained and
+issues were left unresolved. 
+
+1In this report, China and PRC are used interchangeably.
+
+2The chapters in this report are organized chronologically by itinerary. For a complete
+listing of people the delegation met, see References.
+
+ 
+ CRS-2
+
+Despite differences that may exist between the two nations, the meetings also
+
+reflected the deep desire for American congressional staff and Chinese policymakers
+to learn more about each other, to exchange ideas, and to find common ground. The
+Chinese hosts at every meeting in every city extended a gracious hospitality. The
+Chinese sponsors of this trip also ensured that the delegation had the chance to enjoy
+the great cultural heritage that China has, and in this way provided a context of
+China’s history, politics, and economic growth. Members of the group were
+impressed by the broad size and scope of the Chinese nation, from the Great Wall
+outside of Beijing to the dynamism in Hong Kong, and from the rural expanses of the
+Shaanxi province to the growth of development in Shanghai.
+
+ Beijing (August 12th - 16th) 
+
+Most of the meetings that took place in Beijing concerned broad trade and
+
+political issues between the United States and China. The congressional staff
+delegation met with senior Chinese government officials, former members of the
+government (both civilian and military), officials in the U.S. embassy, and with
+representatives from the Boeing Corporation. 
+
+ An Overview of Technology, Trade, and Security Issues 
+
+It became apparent during two weeks of discussions that China’s national
+
+technology policy is viewed by many policymakers, business leaders, academics, and
+others as the engine for China’s future economic growth and development.3
+Invigorating scientific research and access to technology innovation are at the core
+of China’s economic plan for the 21st century. Part of this strategy is a domestic
+policy targeted at strengthening internal science and technology (S&T) resources.
+This strategy is also global. China seeks to obtain a wide range of scientific and
+technological resources to hasten its development. Its relationship with the United
+States, both in cooperation and competition, is viewed by many as critical to
+nurturing and improving its technological capacity. 
+
+Chinese national technology policy is a complex mix of centralized
+
+industrialization, state-run technology parks, and economic development zones.
+While there is a coordinated national policy from Beijing, pockets of local
+entrepreneurial high technology have sprouted all over the country. There also
+continues to be a reluctance to openly exchange many forms of scientific research
+and technology innovation with foreign entities. Yet China appears eager to embrace
+the best and the brightest that foreign research and development sources have to
+offer. This ambivalence was not surprising. It is a country that at once appears to be
+coming into 21st century as an advanced, developed nation, while parts of the country
+
+3Discussions with Yang Jiechi, Assistant Foreign Minister, Ministry of Foreign Affairs
+Beijing, 14 August 1997; Chong Wang, Senior Manager of Public Relations and
+Advertising, China International Economic Consultants Co., Ltd. Beijing, 13 August 1997;
+Cheng Zhen-deng, Senior Engineer, The State Science and Technology Commission,
+Beijing; and Sun Dejiang, Deputy Division Chief Engineer, Department of Planning, The
+State Science and Technology Commission, Beijing, 13 August 1997.
+
+ 
+ CRS-3
+
+struggle to move beyond a largely agrarian past. Therefore, China’s national policies
+at once embrace foreign sources of technology while at the same time reflect some
+suspicion of the outside world.4 
+
+Like many other newly industrializing economies, China’s policies are heavily
+
+focused on applied research and technology commercialization. Several areas of
+scientific research and technology development stood out as priorities for China:
+telecommunications, information technology, aerospace, biotechnology, agricultural,
+and energy. In all of these areas, the Chinese consistently expressed a strong desire
+to improve scientific cooperation and technology transfer between the two nations.
+ 
+
+ Trade Issues. U.S.-PRC trade issues were consistently discussed during the
+
+two weeks the delegation was in China. However, during the time in Beijing, when
+most of the discussions were with Chinese political and policy leaders, trade issues
+dominated. The four major U.S.-PRC trade issues were: 
+
+! The worsening U.S. trade deficit with China. In 1987, the United States had
+
+a $2.8 billion merchandise trade deficit with China. By 1996, the
+merchandise trade deficit surged to $39.5 billion, and in 1997, it was $49.7
+billion.5 From 1991 to 1996, U.S. exports to China increased by 90.5%, while
+U.S. imports from China increased by 171.4%.6
+
+! The composition of goods and services traded between the two countries, and
+
+why this composition is important to U.S. policymakers. According to the
+U.S. Department of Commerce, in 1997 small and medium-sized electrical
+machinery, toys and sports equipment, and footwear accounted for almost all
+of the imports from China to the United States. In terms of U.S. exports to
+China, large-scale machinery, aircraft and spacecraft technologies, electrical
+machinery, and fertilizers constituted the majority of merchandise exported in
+1997. Talks between Chinese officials and the U.S. delegation revolved
+around whether this trade composition is a reflection of real market demand,
+or whether tariff and non-tariff barriers are causing distortions in trade
+composition.
+
+! China’s Most Favored Nation (MFN) trading status with the United States is
+
+not permanent but conditional. U.S. policy has been that certain issues need
+to be addressed by the Chinese before MFN status becomes permanent.
+Chinese officials contended that this is a serious issue for the Chinese people;
+some in the U.S. delegation contended that trade, security, and human rights
+issues must be addressed in China before MFN can be approved. 
+
+4Discussions with Cheng Zhen-deng, Senior Engineer, The State Science and Technology
+Commission, Beijing and Sun Dejiang, Deputy Division Chief Engineer, Department of
+Planning, The State Science and Technology Commission, Beijing, 13 August 1997.
+
+5Department of Commerce, Bureau of the Census, The World Trade Atlas, 28 May 1998.
+
+6Congressional Research Service, China-U.S. Trade Issues , by (name redacted), IB9112
+[updated regularly], p. 1.
+
+ 
+ CRS-4
+
+! China’s acceptance as a member of the World Trade Organization (WTO).
+
+The Chinese consider WTO membership as an important step which would
+indicate recognition of China’s importance in the global economy. Some U.S.
+policymakers have economic and non-economic concerns regarding China’s
+WTO membership. Among the issues discussed were those linking WTO
+membership to ensuring U.S. access to Chinese markets, greater
+democratization in China, improvement in PRC human rights issues, greater
+access to information through the Internet and telecommunications
+technologies, and improving U.S. export control policies to China.7 
+
+Major points of contention between several members of the U.S. delegation and
+
+Chinese officials during meetings in Beijing were the size of the trade deficit (which
+is large), the direction the deficit is taking (growing larger each year), and the
+composition of the trade (small manufactured goods from China, advanced
+technologies and value-added services from the United States). Several members of
+the U.S. group expressed the opinion that it was likely that any improvement in the
+U.S.-PRC relationship would have to start with a change in the trading relationship
+between the two nations. 
+
+ Chinese Position. In response to U.S. concerns about the size, structure, and
+
+composition of the trade deficit, Chinese policymakers emphasized their view that:
+
+! The current merchandise trade deficit with the United States, and particularly
+
+a significant reduction in U.S. exports to China, is a temporary aberration and
+will be brought to equilibrium by free market forces.
+
+! While the trade imbalance with the United States may create tensions, the
+
+Chinese policymakers contend that it is the result of market forces at work,
+and not central government planning.
+
+! The U.S. government has not accurately taken into account Hong Kong trade
+
+as part of the PRC trade equation with the United States, nor accurately
+accounted for U.S. firms manufacturing goods in China for sale in the United
+States.
+
+! The United States harms itself by maintaining complicated and unwise export
+
+control policies, particularly for dual-use technologies and atomic energy.
+These technology exports to China could greatly improve relations between
+the two countries as well as helping redress the trade imbalance issue.
+
+ U.S. Delegation Position. On each of these points, several members of the U.S.
+
+group sought to clarify the U.S. position as well as address Chinese concerns. The
+U.S. groups’ views, while not always unanimous, are summarized in the following
+points. 
+
+7While these were issues raised by the U.S. group during this trip, it should be noted that the
+U.S. Trade Representative does not link specific trade issues with non-trade issues in
+discussions with Chinese officials. 
+
+ 
+ CRS-5
+
+! The trade deficit trend line between the United States and China can be traced
+
+over several years, and is neither a one year aberration nor a short term
+development. 
+
+! While honest disagreements can exist regarding trade policies between
+
+nations, much more can be done to eliminate Chinese tariff and non-tariff
+barriers on U.S. imports.
+
+! While there may be some accounting discrepancies between the two nations,
+
+U.S. officials do not view this as a major contributing factor to the trade
+deficit between the United States and China.
+
+! U.S. export control policies are of concern to many U.S. policymakers, yet
+
+reflect a balance between national security and economic opportunities for
+U.S. firms.
+
+ Linking Trade to Other Issues. Two very contentious policy issues—MFN
+
+status and membership in the WTO — led to a broader policy question often
+discussed between the U.S. delegation and their Chinese hosts (as well as debated
+within the U.S. delegation). Should the United States link trade and non-trade
+political issues—such as human rights—when dealing with China?
+
+ MFN Status. MFN treatment is conferred when one country extends to another
+
+any trade concessions, privileges, and immunities which that country has granted or
+will grant to any trading partner. In other words, trade between the two nations is
+conducted with tariffs that are set at the rate lowest among common trading partners,
+rather than at higher full rates. The United States has extended MFN status to all but
+a few nations, but never extended permanent MFN status to China. It had suspended
+MFN status with China between 1951 and 1980, but then revoked the suspension
+when diplomatic relations between the two nations were restored. From 1980
+through 1989, annual renewal of China’s MFN status was generally uncontroversial,
+with some congressional disapproval.8
+
+The incident in Tiananmen Square in June 1989 caused a strong congressional
+
+reaction. In 1990, Congress undertook a series of legislative initiatives tying China’s
+MFN status with progress in the PRC’s human rights conditions. Several bills
+passed the 102nd and 103rd Congress making renewal of China’s MFN status
+conditional on progress in human rights. Yet President Bush was opposed to linking
+MFN to human rights issues and vetoed the legislation. No legislation withdrawing
+or imposing further conditions on China’s MFN status has passed Congress during
+the Clinton Administration.9 
+
+8Congressional Research Service, Most-Favored-Nation Status and China: History and
+Alternative Approaches to Current Law, by (name redacted), CRS Report 96-992, 10
+December 1996, p. 1-3. 
+
+9Ibid., p. 3, President Clinton announced in 1993 that the U.S. would provide conditions on
+renewing China’s MFN status; however, in 1994 the President announced support for its
+MFN status without conditions linked to human rights issues. 
+
+ 
+ CRS-6
+
+Several Chinese policymakers expressed frustration that the United States has
+
+considered linking MFN status to China’s domestic issues. They contended that
+China has made great progress since 1989 in providing democratic initiatives to the
+Chinese populace. They also contended that the conditional MFN policy “stick” is
+no longer effective in trying to make China comply with U.S. ideals. Not renewing
+China’s MFN status would seriously impair the current trade relations with the
+United States as well as cause significant trade disruptions.10 
+
+There was a range of opinion on this issue within the U.S. group. Some
+
+members flatly rejected a policy linking human rights and other democratic ideals to
+trade relations with China. They contended that to link human rights issues to trade
+policy unfairly imposes an American viewpoint on the current Chinese political
+system. America must view China through a prism that reflects China’s culture,
+history, and political development—not U.S. ideals and aspirations for the PRC.
+
+Others in the U.S. delegation represented the view that MFN for China should
+
+be opposed based on the continuing structural trade deficit with the United States.
+From this point of view, the deficit is not a short-term phenomenon but a longer-term
+problem. Before permanent MFN status is bestowed on China, the structural
+imbalance of the trade deficit must be addressed. This viewpoint articulated the
+concern that once China’s MFN status becomes permanent, there will be no incentive
+for China to redress the long-term trade deficit with the United States.
+
+Yet others in the delegation supported MFN status but believe it should be
+
+linked to progress on human rights issues. This viewpoint contended that it is
+perfectly within the political and philosophical framework of the United States to
+insist that basic conditions of freedom and democracy are in place before a
+permanent business and trading relationship is ratified by Congress.. In particular,
+there was concern that Chinese dissidents continue to be imprisoned without fair
+trials and that free speech and other forms of expression are routinely suppressed.
+Advocates of this position in the U.S. group called for the United States and China
+to exchange information on political prisoners, and hold leadership summits in
+Beijing and Washington to discuss both nations’ humanitarian concerns. 
+
+ Membership in the WTO. Chinese membership in the WTO also was discussed
+
+at great length by Americans and Chinese on this trip. In 1995, the WTO succeeded
+the General Agreement on Tariffs and Trade (GATT) as the major forum for
+discussion of global trade issues. Since the inception of the WTO, China has sought
+membership, in part to have a forum to voice its trade policy and in part as a sign of
+its growing importance and stature in the global community. However, many WTO
+countries contend that China’s trade policies are incompatible with the WTO system
+of what are accepted as standard and fair trading practices. Critics cite China’s
+
+10Discussions with Ambassador Jiang Chengzong, Chinese People’s Institute of Foreign
+Affairs, Beijing, 12 August 1997; Mme. Zhang Yuejiao, Director General, Department of
+Treaty and Law, Ministry of Foreign Trade and Economic Cooperation; William C.
+McCahill, Jr. Deputy Chief of Mission, Department of State, Beijing, 16 August 1997;
+Robert Ludan, Minister-Counsellor, Economic Affairs, Department of State, Beijing, 16
+August 1997.
+
+ 
+ CRS-7
+
+continued centralized trade practices, a lack of movement towards complete
+privatization of enterprises, inadequate protection of intellectual property rights
+(IPR), and evidence of continued non-tariff barriers as some of the issues still
+unreconciled for Chinese membership in the WTO.11 
+
+In response, several Chinese officials contended that it is critical for the global
+
+community to include a major nation like China in the multilateral trading system.
+China is the eleventh largest trading nation in the world, and by some measures, the
+third largest economy in the world.12 Chinese officials contended that WTO
+membership will further open its economy to technology imports, creating a greater
+market for high technology firms seeking to do business abroad. Chinese officials
+also stated that other nations without open economies or completely free market trade
+policies, such as India, Malaysia, and Thailand, are members of the WTO. They
+asked: is there a double standard for China?13
+
+MFN status with the United States and China’s WTO membership are important
+
+issues for both China and the United States. The Chinese position consistently
+emphasized the importance of resolving both issues in a satisfactory manner.
+Members of the U.S. delegation stressed that the U.S. government understands the
+importance of both issues to the PRC, and that a stable trading position with the
+United States and other global partners is a desired outcome. 
+
+ Technology and Security. During discussions on trade issues, concerns were
+
+raised about technology transfer between the two nations. Chinese officials
+uniformly stated that one way to significantly alter the trade imbalance between the
+two nations was to change U.S. export control policy and allow more high
+technology components to be sold to China. In particular, Chinese officials stressed
+the importance of U.S. high technologies and advanced research and development to
+the Chinese economy. Several Chinese government and business leaders called for
+greater U.S. exports of telecommunications and computer technologies, aircraft and
+aerospace industry components, capital equipment and manufacturing technologies,
+and advanced materials and composites. They argued that these technologies would
+continue to spur economic growth and lead to greater domestic stability in China, the
+region, and globally.14
+
+11George Holliday, China’s Application to the World Trade Organization: Are Chinese
+Economic Reforms Sufficient? CRS Report 96-857, p. 2-3.
+
+12Ibid., p. 1.
+
+13Discussions with Ambassador Jiang Chengzong, Chinese People’s Institute of Foreign
+Affairs, Beijing, 12 August 1997; Mme. Zhang Yuejiao, Director General, Department of
+Treaty and Law, Ministry of Foreign Trade and Economic Cooperation, Beijing, 13 August
+1997; and Yang Jiechi, Assistant Foreign Minister, Ministry of Foreign Affairs, Beijing,
+14 August 1997.
+
+14Ibid., China’s policy was summarized very concisely by William C. McCahill, Deputy
+Chief of Mission, Department of State, Beijing, and Robert Ludan, Minister-Counsellor of
+Economic Affairs, Department of State, 16 August 1997.
+
+ 
+ CRS-8
+
+Discussions between members of the U.S. delegation and Chinese policymakers
+
+during this trip explored whether there may be increased opportunities for technology
+transfer between the two nations. Common ground was found in those areas where
+U.S. technological expertise can directly contribute to improving the quality of life
+for the Chinese people (e.g., telephone and telecommunications infrastructure). It
+was also recognized that there continues to be tension between China’s desire for
+U.S. commercial technology transfers and U.S. concerns regarding Chinese use of
+dual-use technology for military applications, as well as proliferation of such
+technologies to other countries. These tensions appear to have increased since
+August 1997.
+
+ Technology Transfer and Economic Growth. The importance of technology
+
+transfer to the PRC was raised often by Chinese officials. Technology was cited as
+the catalyst by which China would fully develop as a nation. Some American
+observers of China believe no long-term relationship is more important to the
+Chinese than the relationship with the United States, because of the need for U.S.
+technologies leading to China’s advancement. These observers view China as poised
+to make an historic political, economic, and social transformation, shedding many
+antiquated aspects of an older system as a new society emerges.15
+
+Chinese officials emphasized the importance of technology transfer as part of
+
+China’s self-image among other developed nations. In this respect, U.S. policies that
+deny technologies to China were described as an affront to the Chinese people. Some
+officials often expressed frustration with U.S. views which they believe “demonize”
+or “chastise” Chinese attempts to obtain advanced commercial technologies. Chinese
+officials contended that any developing country would seek out the most advanced
+and appropriate technology for economic growth. Several officials were of the
+opinion that there is a double standard in U.S. policy towards technology transfer to
+developing countries, in which other developing nations receive appropriate
+technology denied to the Chinese. Some officials appeared perplexed and angered
+by U.S. technology transfer policies.16
+
+ Export Controls. Chinese officials consistently raised two concerns with U.S.
+
+technology transfer policy. The first was over U.S. export control laws and
+regulations. The Chinese position seemed to reflect confusion and irritation over the
+direction and intent of U.S. export control policies. They expressed concern that
+certain technologies, such as basic memory semiconductor chips, can be exported to
+China while more advanced semiconductor chip technologies can be blocked under
+U.S. military control lists. Similarly, while U.S. policies restrict certain types of
+supercomputer technologies for sale to China, Chinese officials stated that they can
+obtain identical technologies from other countries (e.g., France or Japan). Or, the
+Chinese can buy “off the shelf” workstations and other commercial technologies
+
+15William C. McCahill, Deputy Chief of Mission, Department of State, Beijing, and Robert
+Ludan, Minister-Counsellor of Economic Affairs, Department of State, 16 August 1997.
+
+16Discussions with General Xu Xin. President, China Institute for International Strategic
+Studies, Beijing, 13 August 1997; Yang Jiechi, Assistant Foreign Minister, Ministry of
+Foreign Affairs, Beijing, 14 August 1997; and Ambassador Jiang Chengzong, Chinese
+People’s Institute of Foreign Affairs, Beijing, 12 August 1997.
+
+ 
+ CRS-9
+
+from U.S. vendors and “bundle” these technologies for advanced high-performance
+computing.17
+
+Many U.S. policymakers and some business leaders also have questioned U.S.
+
+export controls, believing they are antiquated and at cross-purposes. Basic export
+control policies were established during the Cold War, when U.S. national security
+interests were clearer and well-defined. Some now argue that current export
+restrictions toward China may be attempts by some to create a national security
+threat for the United States where none may now exist.18 However, numerous
+Members of Congress and several private analysts have recently suggested that the
+post Cold War deregulation of exports (and particularly the liberalization of export
+controls by the Clinton Administration) may be contributing to the strategic
+capabilities of potential adversaries. In particular, Congress is currently examining
+the implications of U.S. exports to China of dual-use commodities, licensed by the
+Department of Commerce. Another issue is the transfer of several items from the
+U.S. Munitions List, where they were licensed for export by the Department of State,
+to Commerce Department’s Commodity List, the effect of these transfers on export
+control decisions, and the national security, nonproliferation, and foreign policy
+implications.
+
+Critics in the United States and China also point to conflicting licensing policies
+
+and jurisdictions among the Departments of Commerce, State, and Defense.
+According to the General Accounting Office (GAO), the Department of Commerce
+can justify the license of commercial technology for export using economic and trade
+interests, and it controls items to achieve specific national security and foreign policy
+objectives. The Department of State has a broader authority to deny export, and must
+take national security interests into account before providing export licenses. The
+Department of Defense advises both Departments of Commerce and State on their
+license cases and emphasizes military applications of technology transfer. The GAO
+contends that differing statutory authority among these three agencies has caused
+jurisdictional and procedural uncertainty for U.S. export control policies.19
+
+However, the GAO, upon examining specific technology transfer policies and
+
+actions between the United States and China, also has determined that the Chinese
+government’s role—particularly the military—in technology transfer has complicated
+this issue. The GAO found that in the transfer of both telecommunications and
+machine tool equipment to China, the Chinese military’s role in obtaining and
+
+17This perspective is discussed in: Seymour Goodman, Peter Walcott, and Patrick Homer,
+ High-performance Computing, National Security Applications and Export Control Policy
+at the Close of the 20th Century [Working paper], Department of Commerce, Washington,
+4 May 1998, 200 pages..
+
+18Henry A. Kissinger, “No Room for Nostalgia,” Newsweek, 29 June 1998: 50-52.
+
+19General Accounting Office, Export Controls: Change in Licensing Jurisdiction for Two
+Sensitive Dual-Use Items, GAO/NSIAD-07-24, January 1997, p. 3-4.
+
+ 
+ CRS-10
+
+diverting technology from the United States has raised additional questions about the
+purpose and objective of China’s technology transfer from the United States.20 
+
+Most members of the U.S. delegation acknowledged that more can be done to
+
+streamline U.S. export licensing procedures, clarifying jurisdictional problems
+between U.S. agencies, and making procedural decisions more transparent. However,
+most believed that serious technology transfer problems between the United States
+and China still exist. Some members expressed doubt that the United States would
+change its export control policies towards China, unless the PRC first made very
+transparent its policies of obtaining and using certain foreign technologies. This was
+underscored by the position that until these issues are discussed more openly and
+frankly between both countries, changes in U.S. export control policies which might
+benefit the PRC are unlikely.
+
+ Proliferation. Several Chinese officials protested that the United States has
+
+unfairly and incorrectly portrayed China as an agent of proliferation of military
+weapons and nuclear technologies to rogue nations. During every discussion with
+Chinese officials, this portrayal was denied. Chinese officials consistently spoke of
+a U.S. government report which purportedly cleared China of this portrayal,21 as well
+as the absence of proof from the international community at large that China was
+supplying Iraq, Iran, Pakistan, or any other country with military weapons or nuclear
+technology.22
+
+This claim was countered by official U.S. representatives in Beijing. They stated
+
+that there has been evidence of China’s proliferation activities for several years.
+However, U.S. officials indicated that China appeared to be curtailing some of its
+proliferation activities to other nations. According to the U.S. view in Beijing, in
+1997 Chinese officials recognized that proliferation was a serious impediment to
+U.S.-Chinese relations. U.S. officials also commented that when the United States
+raises proliferation concerns with Chinese officials, China raises concerns about
+weapon sales to Taiwan.23
+
+20General Accounting Office, Export Controls: Sale of Telecommunications Equipment to
+China, GAO/NSIAD-97-5, November 1996, p. 4; General Accounting Office, Export
+Controls: Sensitive Machine Tool Exports to China, GAO/NSIAD-97-4, November 1996,
+p. 1-4.
+
+21It is unclear which U.S. government report the Chinese were referring to. Several officials
+mentioned a Central Intelligence Agency (CIA) report; a 1997 CIA report addressing this
+issue, covering the last half of 1996, described China as “the most significant supplier” of
+goods related to weapons of mass destruction to Pakistan, Syria, and Iran. “China:
+Certifiably What?” The Economist, 25 October 1997: 41.
+
+22Discussions with General Xu Xin. President, China Institute for International Strategic
+Studies, Beijing, 13 August 1997; Yang Jiechi, Assistant Foreign Minister, Ministry of
+Foreign Affairs, Beijing, 14 August 1997; and Ambassador Jiang Chengzong, Chinese
+People’s Institute of Foreign Affairs, Beijing, 12 August 1997.
+
+23Discussions with William C. McCahill, Deputy Chief of Mission, Department of State,
+Beijing, and Robert Ludan, Minister-Counsellor of Economic Affairs, Department of State,
+16 August 1997.
+
+ 
+ CRS-11
+
+Proliferation of specific technologies and their uses also was raised during
+
+discussions. During one such meeting, the Chinese position stressed the importance
+of the nascent national space program, and how China and the United States could
+cooperate in this field.24 Members of the U.S. group asked Chinese officials about
+China’s national policies for containment of launch vehicle and related satellite
+technologies, and the use of these technologies within national boundaries. The U.S.
+delegation was assured that China’s Long March satellite launch program was purely
+commercial in nature, and that there was no intent to pass along vital launch and
+satellite technologies to other nations that could be used for launching missiles. The
+delegation found this Chinese position to be highly suspect.25
+
+ National Interests. According to one source, one-third to one-half of all
+
+economic growth comes from technology progress, and that it is the principal driving
+force for long-term economic growth and increased standards of living for modern
+industrial societies.26 Therefore, it is understandable why China’s national policy for
+obtaining and utilizing the best foreign technologies is vital to its goals of economic
+growth. However, China’s national interest in obtaining technologies may not be
+consistent with those nations that are the source of technology. Those nations often
+restrict or control technologies that they view as inimical to their national economic
+security.
+
+The importance of technology transfer to national economic security policies
+
+was the focus of an animated discussion during a luncheon at the Boeing
+Corporation’s Beijing offices. Officials from Boeing described what it is like to do
+business in China, and cited two key elements for undertaking business in the PRC.
+The first is that it is never “just business” in China, but that personal and political
+relations are key for any foreign firm trying to do business. Boeing officials
+acknowledged that meeting certain host country concessions, such as technology
+transfer, required a balancing of business interests and objectives. If certain
+technology transfer concessions would have to be made to capture Chinese market
+share, Boeing likely would consider this as a good long-term tradeoff.27 
+
+The second key was to balance Boeing’s corporate global perspective with U.S.
+
+national economic and security interests. For Boeing officials, U.S. export control
+policies can hinder the company as it competes against companies from countries
+
+24For background, see: Congressional Research Service, China’s Space Program: A Brief
+Overview Including Commercial Launches of U.S.-Built Satellites, by (name redacted), CRS
+Report 98-575 23 June 1998,15 pages.
+
+25Discussion with General Xu Xin, President, China Institute for International Strategic
+Studies, Beijing, 13 August 1997; proliferation issues were more broadly discussed with
+Yang Jiechi, Assistant Foreign Minister, Ministry of Foreign Affairs, Beijing, 14 August
+1997; and Ambassador Jiang Chengzong, Chinese People’s Institute of Foreign Affairs,
+Beijing, August 1997.
+
+26Ralph Landau and Dale Jorgenson, editors, Technology and Economic Policy. Cambridge,
+Mass.: Ballinger Publishing Company, 1986, p. 2.
+
+27Discussions with Timothy B. Premselaar, Vice President of Customer Service, Boeing
+China Inc., Beijing, and Jiane Chen, Ph.D., Director of Public Affairs, Boeing Commercial
+Airplane Group, Beijing, 14 August 1997.
+
+ 
+ CRS-12
+
+with less restrictive policies. The Boeing officials cautioned members of the
+delegation that, as staff for U.S. policymakers, they should recognize that export
+control policies do not just affect the United States domestically, but have a wider
+impact outside of U.S. borders, which may significantly affect U.S. business
+interests.28 
+
+But several members of the U.S. delegation countered that what may be best for
+
+U.S. multinational corporations may not always be best for U.S. national interests.
+While recognizing the challenges of doing business in a country like China, they
+contended that every country has export controls that would extend to important
+commercial technologies and dual-use commodities. Nor, some in the delegation
+argued, should the United States encourage technology transfer while serious trade,
+employment, and security issues between the two nations have not been resolved.
+
+ Xi’an (August 15th - 17th) 
+
+The congressional group spent several days in the city of Xi’an in the Shaanxi
+
+province. This part of the trip provided members of the group the opportunity to visit
+a high technology center, engage in discussions on current agricultural standards
+issues, and visit many cultural and historical sites in the region. 
+
+ High Technology Center 
+
+The U.S. group made a brief visit to the Xi’an High-Technology Center. The
+
+high technology center, formed in 1991, is a complex of buildings that serves many
+purposes. Office and research space are rented out to entrepreneurs who are seeking
+to develop new innovative ideas or to commercialize scientific inventions. It is also
+a site for joint ventures and direct foreign investment. Since 1991, nearly 300 high
+technology joint ventures have begun at the Xi’an high technology center.29 Upon
+completion of the entire high technology center early in the next century, supporters
+of the center expect 2,000 high technology enterprises to be housed in over a dozen
+buildings.30 
+
+The high technology center is also part of a larger high technology development
+
+plan to establish a high technology zone in the Shaanxi province. According to the
+managers of this high technology center, China now has 52 state-level high
+technology zones. The Xi’an high technology zone is intended to become the
+Chinese high technology version of Silicon Valley or Research Triangle (in North
+Carolina). To that end, the provincial government has established strong ties with
+local universities and colleges to draw upon students with backgrounds in science,
+
+28Ibid.
+
+29Discussions with Zhang Dongfan, Vice Executive Director, The Administrative Committee
+on Xi’an High-Tech Industries Zone, Xi’an, 15 August 1997.
+
+30Ibid. While construction of the high technology center began shortly after its creation in
+1991, only approximately one-third of its facilities were completed by August 1997.
+
+ 
+ CRS-13
+
+engineering, and related technical education. The provincial government also
+provides preferential treatment for newly formed firms at the center.31 
+
+The Xi’an high technology center appears to have potential in a region where
+
+there has been little high technology development and economic growth. The center
+and zone are both intended to attract companies in telecommunications, electronics,
+advanced materials and other high growth fields. However, it was unclear whether
+any new products or commercial innovations had come out of the Xi’an high
+technology center by August 1997. It is also unclear whether this type of state-
+directed high technology program will provide the type of innovative and
+entrepreneurial technology development and commercialization its leaders have set
+as the region’s goal. 
+
+ Agriculture Exports and Sanitary Standards 
+
+The issue of agriculture trade between the United States and China was
+
+discussed several times during this trip. Because the Shaanxi province is a farming
+region, Sino-American discussions on this part of the trip often addressed both
+opportunities and problems of agricultural trade between the two countries.32
+
+According to the Foreign Agricultural Service (FAS) of the U.S. Department of
+
+Agriculture, China’s large and growing population is driving a greater need for
+wheat, coarse grain, corn, and other agricultural goods. Domestic production of
+agricultural products, while expanding rapidly, cannot meet the needs of a population
+now at 1.2 billion. For example, for corn, production is being used to meet increased
+domestic consumption and is not exported.33 
+
+China is an important market for U.S. agricultural exports. In 1996, the United
+
+States exported $2.092 billion in agricultural goods to China. (In the same year, the
+United States imported $597 million in agricultural goods from China). Through
+1997, the United States had a surplus in agricultural trade with China for nine of ten
+years. The most important agricultural exports to China are wheat and cotton, which
+in 1996 together accounted for 56% of U.S. agricultural exports to China. However,
+these export levels for specific commodities can vary greatly from year to year. For
+example, the United States exported $1.1 billion in wheat to China in 1989; in 1990,
+exports of U.S. wheat to China was $497 million.34
+
+31Ibid.
+
+32Shaanxi is not the largest farming region in China, however. The Shandong province is
+a leading producer of wheat and corn, and other provinces with large agricultural interests
+include Henan, Hebei, and Sichuan.
+
+33William Brant, Minister-Counselor, Office of Agricultural Affairs, “The Chinese Market
+for U.S. Agriculture,” [Overview], Department of Agriculture: Foreign Agricultural Service,
+1997.
+
+34Congressional Research Service, The Market in China for U.S. Agricultural Exports, by
+(name redacted) and (name redacted), CRS
+
+ Report 97-807, 27 August 1997, p. 1-2.
+
+ 
+ CRS-14
+
+An important part of the U.S.-PRC relationship is a 1992 Memorandum of
+
+Understanding (MOU) that included terms to standardize import-export policies and
+to reduce tariff and non-tariff barriers. Part of the MOU included an agreement that
+China would use more rigorous scientific measurements for evaluating the sanitary
+and phytosanitary standards of imported agricultural commodities. However, the
+U.S. Trade Representative has concluded that China’s phytosanitary standards are
+“often overly strict, unevenly applied, and not backed by modern laboratory
+techniques.”35
+
+China’s use of sanitary and phytosanitary standards36 to restrict U.S. imports,
+
+particularly that of wheat, was discussed. Some Chinese and Americans expressed
+a belief that China and the United States can find a common ground in their bilateral
+agricultural policy. Some members of the U.S. delegation, especially those from rural
+states, stressed the importance of increasing U.S. agricultural exports to China as a
+way of improving relations between the two nations. China continues to indicate that
+it is receptive to increasing its agricultural trade with the United States, but has linked
+that action with obtaining MFN status with the United States, and eventual
+membership into the WTO.37 
+
+ Political and Cultural History 
+
+The visit to Xi’an included several visits to museums, ancient burial grounds,
+
+temples, and other historical sites. It provided members of the delegation an
+opportunity to better understand the political and cultural history of China, and to
+better comprehend the enormous size, scope, and diversity of the nation.
+
+One of the most important cultural and historical lessons learned during this part
+
+of the trip was that China’s long history has been marked by periods of unity and
+disunity, in which imperialism and autocracy brought together disparate groups
+interspersed by periods of separatism and provincial discord. For some Chinese
+policymakers and foreign Sinologists, this history provides a cautionary note that
+political, cultural, and ethnic ties which appear to unite China today may be more
+tenuous than viewed from the outside.38
+
+35Office of the U.S. Trade Representative, 1998 National Trade Estimates Report, p. 50.
+
+36Sanitary (human and animal health) and phytosanitary (plant health) measures are laws,
+decrees, standards, regulations, guidelines, and procedures that protect human, animal, or
+plant life and health primarily from risks arising from additives, contaminants, toxins, pests,
+or diseases in foods, animals, or plants. See: Congressional Research Service, Sanitary and
+Phytosanitary Safety Standards for Foods in the GATT Uruguay Round Accords, by (name
+ redacted), CRS Report 94-512, 21 June 1994, 30 pages.
+
+37William Brant, Minister-Counselor, Office of Agricultural Affairs, “The Chinese Market
+for U.S. Agriculture,” [Overview], Department of Agriculture, Foreign Agricultural Service,
+1997. The problem of differing U.S. and Chinese sanitary and phytosanitary policies also
+was discussed by William C. McCahill, Jr. Deputy Chief of Mission. Department of State,
+Beijing, 16 August 1997.
+
+38Emily MacFarquhar, “Back to the Future in China,” U.S. News and World Report, 12
+March 1990, p. 40-48.
+
+ 
+ CRS-15
+
+The city of Xi’an figures prominently in the earliest history of what is now
+
+China.39 It was Qin Shi Huang Di (259-210 B.C.) who established the first unified
+imperial dynasty in China at Xi’an and ordered the creation of 6,000 life-sized terra
+cotta soldiers. Xi’an served as China’s capital over 11 dynasties, from the Qin
+Dynasty and its successor, the Han Dynasty (206 B.C.-A.D. 220), to the Tang
+Dynasty (618-907).40
+
+The region around Xi’an also become the crossroads for the development of
+
+several religious and philosophical tenets during the era of “The Hundred Schools of
+Thought” (approximately 400-200 B.C.). Among the first of the philosophies
+developed was Confucianism, a philosophy adapted by a scholars who sought to
+create a social and political ideal unifying the Chinese people. This system
+prescribed a series of orderly relationships within a society (“Let the ruler be a ruler
+and the subject a subject”) based on ethical relationships and moral good.41
+
+Chinese Legalism, also known as the School of Law, was diametrically opposed
+
+to Confucian thought, and vied for followers during this period. It was a philosophy
+based on authoritarian control of government, not ethical or moral persuasion.
+Legalists exalted the state and sought prosperity and marital prowess above the
+welfare of the common people. During the Han Dynasty, the tenets of Confucianism
+and Legalism were combined to create a working imperial form of government. The
+tension inherent in these two philosophies of the “Rule of Man” versus the “Rule of
+Law” approach to government is still evident in modern China.42
+
+ Shanghai (August 18th - 21st) 
+
+Shanghai is one of the most rapidly growing cities in China, with a 1997
+
+population of 14.7 million, the fifth largest in the world.43 It was the first Chinese
+city opened to western trade (1842), and at the beginning of the 20th century became
+China’s largest industrial center. Although closed off from western interaction after
+1949, it retained its lead as China’s center for industrial, scientific, and technological
+development for nearly fifty years. Since normalization of relations with most of the
+West since the late 1970s, issues involving Shanghai’s development are technology
+and capital formation, the role of state-owned-enterprises (SOEs) and multinational
+enterprises (MNEs), and telecommunications and Internet development.44
+
+39Library of Congress, Federal Research Division, China: A Country Study , by Robert L.
+Worden, Andrea Matles Savada, and Robert E. Dolan, editors, July 1987, p. 5.
+
+40J.D. Brown, “Chinese City in Transition,” The New York Times, 14 March 1994.
+
+41Library of Congress, Federal Research Division, China: A Country Study , by Robert L.
+Worden, Andrea Matles Savada, and Robert E. Dolan, editors, July 1987, p.7-10..
+
+42Ibid.
+
+43Its population by 2015 is expected to be 23.4 million.
+
+44 The World Almanac and Book of Facts, World Almanac Books, 1997, p. 838, and The
+New Encyclopaedia Britannica, v. 27, 1997, p. 284-288.
+
+ 
+ CRS-16
+
+ Technology and Capital Formation 
+
+Shanghai has three major districts: central Shanghai, which consists of the oldest
+
+part of the city; the large agricultural areas of the rural hinterlands forming the edge
+of the metropolitan area; and the transitional zones in between the two. The Pudong
+district is one such transitional zone, and is home to a science and technology park
+as well as several public and private research and development centers.
+
+The Shanghai (Z.J.) Hi-Tech Park was created in 1992 as the first step of a
+
+larger “technopolis” encompassing most of the Pudang district of Shanghai. As with
+its counterpart in Xi’an, the Shanghai (Z.J.) Hi-Tech Park, when completed, will be
+impressive in size and scope. It will cover 17 square kilometers and employ over
+10,000 scientists, engineers and researchers.45 The main purpose of the park is to
+encourage foreign investment and joint ventures in research and development (R&D).
+A preferential tax policy for foreign firms locating in this park was outlined by
+officials at the park. This includes tax moratoria and holidays for long-term R&D
+investment by foreign firms.46
+
+While the official emphasis at Shanghai (Z.J.) Hi-Tech Park is to encourage
+
+domestic and foreign private sector investment, it was clear that American and
+Chinese interpretations of how to implement this policy differed. Chinese officials
+at the park were asked by members of the U.S. delegation what could be done to
+further encourage U.S. high technology firms to consider Shanghai (Z.J.) Hi-Tech
+Park for R&D joint ventures. The Chinese officials responded that the U.S.
+government should lead companies to Shanghai, and it should be U.S. public policy
+to interest U.S. firms in relocating to the park. Even when members of the delegation
+explained that this is not an appropriate role for government in the American context,
+the Chinese position remained unchanged.47
+
+The issue of attracting foreign investment for technology development also was
+
+central to discussions with representatives of the U.S. insurance firm American
+International Group/American International Assurance Co., Ltd. (AIG/AIA).
+Representatives from this company stated how difficult it is to sell insurance and
+other forms of financial instruments in Shanghai and the rest of China. They
+contended that many Chinese still have a strong suspicion of foreign financial
+companies, and that life and property insurance are new concepts for most Chinese.
+For many Chinese, the risk/reward for investment resides only with savings accounts
+in Chinese banks that pay very low interest rates. Representatives from AIG/AIA
+indicated that further industrialization and technology development and
+commercialization may be hindered if Chinese capital is not invested more
+constructively.48 
+
+45 Investment Guide , Shanghai (J.Z.) Hi-Tech Park, [English version] 1997, 19 pages.
+
+46Discussions with Honglian Hu, Vice President, Z.J. Hi-Tech Park, and Shirley Zhao, Sales
+and Marketing, Z.J. Hi-Tech Park Development, Shanghai, 19 August 1997.
+
+47Ibid.
+
+48Of course, their view of “more constructive” capital investments would be through their
+
+(continued...)
+
+ 
+ CRS-17
+
+One source of investment capital for technology development and
+
+commercialization may be the Shanghai Stock Exchange. Created in 1990 with just
+eight companies publicly traded, the Shanghai Stock Exchange had 628 members by
+August 1997, with over half of those firms issuing two forms of stock.49 However,
+it was unclear from discussions how much of the investment in the Shanghai
+Exchange was used for capital investment in Shanghai as opposed to being secondary
+market transactions among buyers and sellers. When asked about this, Chinese
+officials contended that while there will always be some speculative money, most of
+the investment was sound. As proof, they indicated that as of August 1997 neither
+the Shanghai Exchange nor China as a whole was affected by the economic downturn
+which had begun in Indonesia, Korea, and Japan.50
+
+ SOEs and MNEs 
+
+State-owned-enterprises (SOEs) are those companies started, managed, and
+
+supported by the Chinese government. Multinational enterprises (MNEs) are mostly
+foreign firms, independent of government control, that have established production,
+sales, and/or R&D in China. In Shanghai, the congressional staff delegation met
+representatives from General Motors (GM) and Nike Sports Company, Ltd., two U.S.
+MNEs. The delegation found:
+
+! At GM China Inc., there is a complex relationship between GM, the central
+
+government in Beijing, the Shanghai provincial government, Chinese
+suppliers, several Chinese SOE auto manufacturers, and other foreign auto
+firms competing in China. For GM, having to work with so many disparate
+interests was inefficient and uneconomical. To address this problem, GM
+provides 50% funding for the Shanghai Automotive Industry Group (SAIG),
+a joint venture automobile manufacturing facility with the Shanghai provincial
+government. This provides GM with a single Chinese-affiliated entity with
+which to do business.51
+
+! Nike’s Shanghai branch office represents the company’s sales and marketing
+
+interests in China. This operation began in 1984, and every year since, Nike
+
+48(...continued)
+company’s investment instruments. Discussions with Bethy Wu, Assistant Manager, Human
+Resources Department, AIG/AIA; Jacob N.K. Wong, Deputy General Manager,
+Administration, AIG/AIA; Daniel C. Zhou, Accident and Health Manager, AIG/AIA,
+Shanghai, 19 August 1997.
+
+49These are “A” shares, which are primary shares in a company, and “B” shares, which are
+somewhat like convertible stock in the United States. Discussions with Dr. Hio Rio Yin,
+Vice Director, Development and Research Centre, Shanghai Stock Exchange and Li Qian,
+Director of Public Relations, President’s Office, Shanghai Stock Exchange, Shanghai, 20
+August 1997.
+
+50Ibid.
+
+51Discussions with John Wilson, Attorney, General Motors Overseas Corporation; William
+J. Barclay, Executive Director of Finance, GM China Inc., Shanghai Automotive
+Operations, and Sherrie Childers, Manager, Public affairs, GM China Inc., Shanghai
+Automotive Operations, Shanghai, 19 August 1997.
+
+ 
+ CRS-18
+
+has lost money, including $9 million in 1996. However, company
+representatives stated that Nike is committed to long-term business growth in
+the PRC. The biggest problem facing this U.S. company is protection of
+intellectual property rights against piracy, and what they described as the
+PRC’s bureaucratic and often corrupt distribution system for their goods.52
+
+In Shanghai, as elsewhere on this trip, there were indications that China is going
+
+through a difficult era of privatization as it tries to reduce or eliminate its SOEs.
+However, if the Chinese government removes all support for these firms, most will
+not be able to compete. The potential for large scale unemployment if workers from
+Chinese SOEs cannot find work elsewhere is a major concern for China. As of
+August 1997, there already was some indication of worker displacement and massive
+shifts of population as China tries to address issues of privatization and free
+enterprise.53 
+
+ Telecommunications and the Internet 
+
+Shanghai also was representative of the great growth in telecommunications
+
+infrastructure, applications, and services in China. There was evidence in central
+Shanghai and Pudong of long lines of fiber optic cable, new satellite dishes on
+buildings, and construction of terrestrial communications relay towers. The Shanghai
+Stock Exchange had just recently been completely rewired for global trading.
+
+In the rest of China, there has been an explosion of telecommunications
+
+technologies and applications. This has been most evident in the growth of the
+Internet in China. In 1993, only about 20,000 Chinese had access to the Internet. By
+the time of the delegation’s trip, that figure was about 250,000. In 1998, it is over
+600,000. Chinese officials forecast that the number of Internet users in China will
+be two million by 2000, and seven million by 2001.54 
+
+One of the impacts of this growth in Internet use is its effect on the global
+
+economy. From discussions with U.S. business representatives in Shanghai,
+education and training of Chinese students in computer science and related fields
+represents one of the most popular areas of academic study.55 These students are just
+beginning to enter the workforce. One expert describes many of the new information
+technology and service workers as “virtual aliens.” Instead of making high-level
+professional wages as they would in the United States, these information technology
+
+52Discussions with Harry Johnson, General Manager, Nike Sports Company Ltd., Shanghai
+Branch Office; Frank Chen, Marketing Director, Nike Sports Company Ltd; and Martha
+Benson, Director of Communications/Asia Pacific, Nike International Ltd., Shanghai, 20
+August 1997.
+
+53Discussions with Yang Guoqiang, Deputy Director-General, Foreign Affairs Office,
+Shanghai Municipality, Shanghai, 19 August 1997.
+
+54“China and the Internet,” Reuters, http://www.nuia.ie/surveys/index.cgi?service. 
+
+55Discussions with Bethy Wu, Assistant Manager, Human Resources Department,
+AIG/AIA.; Jacob N.K. Wong, Deputy General Manager, Administration, AIG/AIA; Daniel
+C. Zhou, Accident and Health Manager, AIG/AIA, Shanghai, 19 August 1997.
+
+ 
+ CRS-19
+
+workers are employed by U.S. companies at a much lower wage than comparable
+U.S. workers. They have been characterized as “virtually” U.S. employees for a U.S.
+company; “fully networked and employed as members of the U.S. economy, they
+don’t pay U.S. taxes and may never even have visited the United States.”56 
+
+But the Internet does not yet represent a total communications revolution in
+
+China. In a country of 1.2 billion people, 0.4% of households reportedly have
+personal computers.57 Most Chinese citizens are unlikely to have access to
+computers and global communications networks well into the next century. Even
+telephones, while becoming more common, reach about 6% of the population.58 It
+also is unclear whether China’s official policies toward Internet use and
+communications will permit this growth or have to change because of it. In 1996, a
+law was passed requiring all Chinese who use the Internet to register with Beijing.
+China’s official policy on the Internet continues to restrict its access and use by
+ordinary citizens.
+
+ Hong Kong (August 22nd and 23rd) 
+
+The last part of the trip consisted of one full day of meetings in Hong Kong.
+
+Discussions focused mainly on the impact of the turnover of Hong Kong from British
+to Chinese rule. Other points of discussion included political freedom and territorial
+sovereignty.
+
+ Hong Kong After July 1, 1997 
+
+At midnight, June 30, 1997 Hong Kong reverted to Chinese sovereignty, after
+
+150 years of British rule. The transfer of power was the result of a 1984 Sino-British
+Joint Declaration which established a “one country, two systems” principle of
+transfer. The PRC has pledged to leave in place Hong Kong’s open capitalist system
+for at least fifty more years.
+
+On the surface, little seemed to have changed in Hong Kong in the nearly sixty
+
+days between the transfer and the delegation’s visit. Hong Kong has a population of
+5.5 million, with a population density per square mile of 15,158.59 It gave the
+appearance of continuing to be a thriving mercantile center and there was no civil
+disruption or interference with activities after the turnover. Most of the discussions
+
+56Dan Tapscott, The Digital Economy: Promise and Peril in the Age of Networked
+Intelligence, New York: McGraw-Hill, 1997, p. 5.
+
+57In the United States, it is 40%. Mark Landler, “Hong Kong Tycoon Seeks Internet
+Success, The New York Times, 13 April 1998, http://www.nytimes.com.
+
+58Karl Gude and Silvio da Silva, “China by the Numbers: Portrait of a Nation,” Newsweek,
+ 29 June 1998, p. 24. In the United States, about 94% of the population has direct access to
+telephones.
+
+59In the United States, population per square mile is 75; in the rest of the PRC, it is 327,
+Anna Kuchment, “For Richer or Poorer. . .” Newsweek, 19 May 1997, p. 40. 
+
+ 
+ CRS-20
+
+we had with both Hong Kong natives and American business leaders expressed
+continued confidence in Hong Kong’s growth and prosperity. 60 
+
+ Political Freedom61 
+
+Many leaders in Hong Kong acknowledged that a very important question will
+
+be answered over the next several years: can the Hong Kong which they have known
+survive as a part of China? While economic conditions are somewhat guaranteed,
+can the same be said for political freedom and protection of individual rights?62
+
+Interestingly, for many long-time residents of Hong Kong, democratic ideals of
+
+political freedom and protection of individual rights have come somewhat late in
+Hong Kong’s history. Many natives of Hong Kong were disenfranchised during most
+of the British rule, and Chinese resentment over foreign rule was strong even at the
+time of the turnover. Still, some would argue that real power in Hong Kong resides
+in the marketplace, and not in legislative bodies.63 
+
+As of August 1997, most Hong Kong observers with whom we met said that
+
+they expected a smooth transition as the Provisional Legislative Council (“Legco”),
+appointed on July 1, 1997, by Beijing, is replaced by one elected more directly
+(elections were scheduled for May 28, 1998). Elections for Legco only began to be
+held in 1985, with the first wholly-elected Legco not occurring until 1995. These
+elections were based on a “20-30-10” formula of geographic representation (direct
+elections), functional representation (with elected slots determined by occupation and
+position in society), and by an appointed election committee.64 
+
+60One interesting note occurred during a talk with the head of Hong Kong’s Futures
+Commodities Exchange. He was asked what he thought of the possible speculative nature
+of global financial markets, and with forty years of experience in finance and investing,
+what would be his advice to U.S. stock investors. His reply: “Get out (of the U.S. stock
+market) now.” Discussion with Ivers Riley, Chief Executive Officer, Hong Kong Futures
+Exchange Ltd., Hong Kong, 22 August 1997. [The S&P 500 has increased 25% since that
+time.]
+
+61The group did not meet with Martin Lee or with any of the members of the Pro-Democracy
+movement.
+
+62Discussions in individual meetings with Dr. Patrick Leung, Chairman, Vision 2047
+Foundation, Hong Kong; Arthur NG Sek-hon, Deputy Secretary for Constitutional Affairs,
+Hong Kong; and Nellie K.M. Fong, Chairwoman, Executive Committee, Better Hong Kong
+Foundation, 22 August 1997. 
+
+63Discussions in individual meetings with Arthur NG Sek-hon, Deputy Secretary for
+Constitutional Affairs, Hong Kong, and Mr. Richard Margolis, First Vice President, Equity,
+Merrill Lynch, Member, Vision 2047 Foundation, 22 August 1997.
+
+64British officials hoped this 1995 Legco could serve through the 1997 transition — a
+concept called “through train.” But the Chinese government dissolved the 1995 Legco
+shortly after the turnover and crafted new electoral rules for elections to be held in 1998.
+However, the new rules still allow for the “20-30-10" formula. See: Congressional
+Research Service, Hong Kong’s “Provisional Legislature Controversy” by (name
+ redacted), CRS Report 97-557, 10 pages.
+
+ 
+ CRS-21
+
+Several Hong Kong legal experts contended that among the many implications
+
+of this change in electoral representation Hong Kong’s “Rule of Law” will influence
+or supplant the “Rule of Man” tradition in China. They stated that despite British
+occupancy—or perhaps because of it—Hong Kong has enjoyed a very clear and
+concrete legal system. Therefore, China, with its history of autocratic rule in Beijing
+and interests of provincial party officials, has had a history of “Rule of Man,” in
+which the mandate of an individual or the party may supersede legalisms.65 
+ 
+
+The answer of which system will emerge as Hong Kong is assimilated into
+
+China is still unknown. U.S. officials generally viewed the developments post-July
+1, 1997 with optimism tinged with realism. Some Hong Kong officials contended
+that difficult issues, such as protection of foreign intellectual property rights (patents,
+copyrights, and trademarks), abused in both Hong Kong and China, may be resolved
+under a unified “Rule of Law.” Yet, some in Hong Kong stated that, conversely,
+freedom of the press and free speech may be curtailed if a Beijing “Rule of Man” is
+extended to Hong Kong. Chinese and American observers commented that even a
+third scenario, which involves a compromise of both the “Rule of Law” and “Rule
+of Man,” may create a peaceful, if uneasy, coexistence, between Hong Kong and the
+rest of China.66
+
+ Territorial Sovereignty67 
+
+Many residents and observers in Hong Kong which the delegation met with
+
+expressed great confidence (although mixed with some concern) that Hong Kong will
+essentially retain its unique character. In several meetings, the issue was not whether
+China will influence, and therefore change, Hong Kong; but how much Hong Kong’s
+unique mix of economic, trade, political, and democratic characteristics may change
+China.
+
+The future of Hong Kong also involves larger issues of Chinese territorial
+
+sovereignty in the Asia Pacific region. Hong Kong has served as a gateway for much
+of China, and therefore can be seen as an aperture through which technology, trade,
+and security issues flow. As part of an experiment in “one country, two systems,” the
+Chinese appear anxious to demonstrate that it can successfully and peacefully
+complete Hong Kong’s transition. Still, it was also very clear that many Chinese now
+view Hong Kong as a domestic issue, and no longer subject to outside interference.
+
+For many Chinese officials, if Hong Kong can be successfully adopted into
+
+China’s national political and economic system, then the next goal would be to look
+
+65Discussions with Daniel R. Fung, Solicitor General, Department of Justice, Hong Kong,
+22 August 1997, See also: Bruce Einhorn, “Hong Kong: Now the Rule of Law is in
+Jeopardy,” BusinessWeek, 20 April 1998.
+
+66Discussions in individual meetings with Richard Boucher, Counsel General. American
+Counsulate General, Hong Kong, and Professor Ng Ching Fai, Provisional Legislative
+Councilor, Hong Kong, and Dr. Wong King Keung, Former Preparatory Committee
+Member, Hong Kong, 21 August 1997.
+
+67The following issues, while described as part of the Hong Kong turnover, were also a part
+of almost every discussion during the two weeks the delegation was in China. 
+
+ 
+ CRS-22
+
+towards Taiwan and apply the “one country, two systems” policy there as well. To
+some, Taiwan’s absorption into China is inevitable, and would have already occurred
+without an American presence. U.S. technology, trade, and security policies toward
+Taiwan are an irritant to the Chinese. They contend that U.S. support of Taiwan
+interferes with China’s domestic policy of reunification. The U.S. delegation
+generally pressed for greater dialogue (and change) in U.S.-PRC technology, trade,
+and security policies; many Chinese officials in turn addressed U.S. policy towards
+Taiwan as the major obstacle for improving relations.68
+
+ Epilogue: Developments Since August 1997 
+
+U.S.-Chinese relations since August 1997 appear to follow the old Chinese
+
+proverb (both a blessing and a curse): “May you live in interesting times.” A variety
+of technology, trade, and security, as well as other economic and political issues,
+remain at the forefront of the U.S.-PRC relationship. The following developments
+are among the highlights of this changing relationship.
+
+In September 1997, the Chinese People’s Congress met to elect party officials
+
+and to set national policies for the next year. President Jiang Zemin was expected by
+some to emerge from the congress much weaker in power and with his economic
+reform policies greatly diluted. However, according to some observers, Jiang was
+able to handle internal party factions and avoided open confrontation from both hard-
+line conservatives and liberal reformers.69
+
+During the fall of 1997, the “Asian contagion” of falling currency valuations in
+
+Indonesia and Thailand spread to Korea and affected other nations like Japan and
+China as well. In China, the economic downturn came at a time when official
+Chinese policy encouraged the privatization or dismantling of many SOEs considered
+to be inefficient or inoperative. The impact on unemployment was fairly severe,
+causing disruptions in the workforce. As currencies in several nations were
+devalued, many U.S. multinational corporations reported that their earnings, some
+based in large part on overseas sales, would be adversely affected.70
+
+In October, President Jiang Zemin visited the United States to meet with
+
+President Clinton. President Jiang signed an order for the Chinese government to
+buy fifty Boeing aircraft for $3 billion. Presidents Jiang and Clinton also agreed that
+in exchange for China’s promise to limit nuclear trade with rogue states, the United
+States would lift a U.S. ban of non-military nuclear technology. President Clinton
+described it as a “win, win, win” situation for U.S. technology, trade, and security
+
+68Another territorial issue was Tibet, which came up infrequently during discussions. Most
+Chinese officials we met consider Tibet to be a purely internal matter. The U.S. delegation
+did not raise it often, and when the issue of hegemony over Tibet was raised, most Chinese
+had very little to say about the situation.
+
+69“Out of the Shadow of Deng,” The Economist, 20 September 1997: 39-40.
+
+70“Will the World Slump?” The Economist, 15 November 1997: 15; 19-21; 77; and “A
+Lorry-Load of Trouble in Asia,” The Economist, 6 December 1997: 65-66.
+
+ 
+ CRS-23
+
+objectives; critics contended that there was no enforcement in the agreement for
+China to honor its commitments.71
+
+In December, in Kyoto Japan, a United Nations summit on global climate
+
+change focused attention on what could be done to reduce emissions of so-called
+“greenhouse gasses” that are thought to be warming global climate. The Kyoto
+Protocol was considered controversial because it failed to set commitments for
+developing countries — including China — to reduce greenhouse gas emissions that
+other signatories would have to meet. These commitments had been requested by
+President Clinton and by the U.S. Senate in S.Res. 98 (approved 95-0 on July 25,
+1997).72
+
+Also in December, elections were held in Hong Kong. China reported that the
+
+voting was direct and open, resulting in the election of 36 deputies to sit in the
+National People’s Congress. However, others contended that most of the elected
+deputies were Beijing party faithful, selected by a small core of 424 “qualified”
+delegates in Hong Kong.73 Elsewhere, Chinese territorial policies continued to raise
+western concerns. Tensions between China and Taiwan were heightened after
+Taiwan reaffirmed its independent status. In the far western province of Xinjiang,
+over a million troops were dispatched to quell a separatist movement. 
+
+For the first quarter of 1998, the Department of Commerce reported that the
+
+U.S. trade deficit with China was about $11.5 billion. This represents an increase of
+19% over the first quarter of 1997. At this rate, the U.S. 1998 trade deficit with
+China would exceed 1997, and could possibly pass the trade deficit the United States
+currently has with Japan. However, the United States continues to run a surplus in
+agricultural trade with China, with preliminary figures indicating that most
+agricultural trade with China is ahead of 1997 trade.74 
+
+In 1998, proliferation in the Asian region became a global concern. In May,
+
+India conducted five nuclear tests and Pakistan responded by detonating nuclear
+devices of its own. The nuclear tests increased tensions between two nations that
+have fought three wars in the last fifty years. In announcing his country’s successful
+nuclear test, Pakastani President Sharif publicly thanked China for making its nuclear
+technology available. 75
+
+71“Jian Zemin’s Visit: Trick or Treat?” The Economist, 1 November 1997: 26-27.
+
+72Given these developments, there is little prospect at present that the Senate will give its
+advice and consent to ratification; consequently, the Administration is not expected to send
+the protocol to the Senate in 1998. Congressional Research Service, Global Climate Change,
+ (name redacted) and John R. Justus, IB89005 [updated regularly].
+
+73“Rotten Boroughs,” The Economist, 13 December 1997.
+
+74Department of Commerce, Bureau of the Census, The World Trade Atlas, (Provided by
+(name redacted), Congressional Refere nce Division Library of Congress).
+
+75Michael Hirsh and John Barry, “Nuclear Jitters,” Newsweek, 8 June 1998: 22-27 and
+“Asia’s Shockwaves,” The Economist, 16 May 1998: 15-16. See also: Congressional
+Research Service, India-Pakistan Nuclear Tests and U.S. Response, by (name redacted),
+
+(continued...)
+
+ 
+ CRS-24
+
+Tensions between the United States and China over technology transfer also
+
+extended to several commercial and dual-use technologies. A series of news stories
+and government reports in the spring of 1998 indicated that several U.S. firms may
+have improperly or illegally shared technology and information with Chinese
+scientists and engineers. The 105th Congress began a series of hearings on U.S.
+export control policies and possible Chinese violations of U.S. national security laws
+in obtaining satellite, machine tool, and supercomputer technologies.76
+
+Against this backdrop, President Clinton visited China in late June 1998. The
+
+President visited Xi’an, Beijing, Shanghai, and Hong Kong during his two week visit.
+Addressing issues of political freedom and freedom of speech, he condemned the
+Tiananmen Square incident of 1989 and called for more democratic reforms in
+China. He also vowed to improve trade and other economic ties between the United
+States and China. President Clinton expressed support of China’s “one nation, two
+systems” approach while in Hong Kong and stated that the United States would not
+support Taiwan’s independence. In turn, the Chinese government announced that
+it would agree to a framework agreement to better control the unauthorized use of
+technology exported from the United States to China. 
+
+75(...continued)
+(name redacted), Jonathan Medalia, and Dianne Rennack.
+
+76Congressional Research Service, Space Launch Vehicles: Government Requirements and
+Commercial Competition, by (name redacted), IB93062 [updated regularly]; (name redacted),
+ China: Possible Missile Technology Transfers from U.S. Satellite Export
+Policy—Background and Chronology, CRS Report 98-485, 20 May 1998, 20 pages; and
+(name redacted), 
+
+ China’s Economic Conditions, IB98014 [updated regularly].
+
+ 
+ CRS-25
+
+ References 
+
+ Discussions 
+
+William J. Barclay. Executive Director of Finance. Shanghai Automotive Operations.
+
+General Motors China, Inc. August 19, 1997. 
+
+Martha Benson. Director of Communications/Asia Pacific. Nike International Ltd.
+
+Shanghai. August 20, 1997.
+
+Richard Boucher. Counsel General. American Counsulate General. Hong Kong.
+
+August 21, 1997. 
+
+Frank Chen. Marketing Director. Nike Sports Company Ltd. Shanghai Branch
+
+Office. Shanghai. August 20, 1997.
+
+Dr. Jiane Chen. Director of Public Affairs. Boeing Commercial Airplane Group.
+
+Beijing. August 14, 1997.
+
+Cheng Zhen-deng. Senior Engineer. The State Science and Technology Commission.
+
+Beijing. August 13, 1997.
+
+Sherrie Childers. Manager. Public Affairs. Shanghai Automotive Operations.
+
+General Motors China, Inc. August 19, 1997.
+
+ 
+Nellie K.M. Fong. Chairwoman. Executive Committee. Better Hong Kong
+
+Foundation. August 22, 1997.
+
+Daniel R. Fung. Solicitor General. Department of Justice. Hong Kong. August 22,
+
+1997.
+
+Honglian Hu. Vice President. Shanghai (Z.J.) Hi-Tech Park. Shanghai. August 19,
+
+1997.
+
+Jiang Chengzong. Ambassador. Chinese People’s Institute of Foreign Affairs.
+
+Beijing. August 12, 1997.
+
+Yang Jiechi. Assistant Foreign Minister. Ministry of Foreign Affairs. Beijing. August
+
+August 14, 1997.
+
+Harry Johnson. General Manager. Nike Sports Company Ltd. Shanghai. August 20,
+
+1997.
+
+Lang Shuang. British Affairs Officer. Chinese People’s Institute of Foreign Affairs.
+
+Beijing. August 12, 1997. 
+
+Dr. Patrick Leung. Chairman. Vision 2047 Foundation. Hong Kong. August 22,
+
+1997.
+
+ 
+ CRS-26
+
+Li Qian. Director of Public Relations. President’s Office. Shanghai Stock Exchange.
+
+Shanghai. August 20, 1997.
+
+Robert Ludan. Minister-Counsellor. Economic Affairs. U.S. Department of State.
+
+Beijing. August 16, 1997. 
+
+Richard Margolis. First Vice President, Equity. Merrill Lynch. Member, Vision 2047
+
+Foundation. August 2, 1997.
+
+William C. McCahill, Jr. Deputy Chief of Mission. U.S. Department of State.
+
+Beijing. August 16, 1997. 
+
+Dr. Mark C. Michelson. Managing Director. APCO Asia Ltd. Member, American
+
+Chamber of Commerce. Hong Kong. August 22, 1997.
+
+Arthur Ng Sek-hon. Deputy Secretary for Constitutional Affairs. Hong Kong. August
+
+22, 1997.
+
+Professor Ng Ching Fai. Provisional Legislative Councilor. Hong Kong. August 21,
+
+1997.
+
+Timothy B. Premselaar. Vice President of Customer Service. Boeing China Inc.
+
+Beijing. August 14, 1997.
+
+Ivers Riley. Chief Executive Officer. Hong Kong Futures Exchange. Ltd. Hong
+
+Kong. August 22, 1997. 
+
+Kelly B. Snyder. Second Secretary. Economic Section. U.S. Department of State.
+
+Bejing. August 16, 1997.
+
+Sun Dejiang. Deputy Division Chief Engineer. Department of Planning. The State
+
+Science and Technology Commission. August 13, 1997.
+
+Tam Wing Pong. Deputy Secretary for Trade and Industry. Special Administrative
+
+Region. The Government of Hong Kong. August 22, 1997.
+
+Chong Wang. Senior Manager of Public Relations and Advertising. China
+
+International Economic Consultants Co., Ltd. Beijing. August 13, 1997.
+
+Wang Mei. Vice Director. Projects and Foreign Affairs Department. Administrative
+
+Committee of Xi’an High-Tech Industries Development Zone. Xi’an. August
+15, 1997.
+
+John Wilson. Attorney. General Motors Overseas Corporation. Shanghai. August 19,
+
+1997.
+
+Jacob N.K. Wong. Deputy General Manager. Administration. AIG/AIA. Shanghai.
+
+August 19, 1997.
+
+ 
+ CRS-27
+
+Dr. Wong King Keung. Former Preparatory Committee Member. Hong Kong.
+
+August 21, 1997. 
+
+Bethy Wu. Assistant Manager. Human Resources Development. AIG/AIA. Shanghai.
+
+August 19, 1997.
+
+General Xu Xin. President. China Institute for International Strategic Studies.
+
+Beijing. August 13, 1997. 
+
+Yang Guoqiang. Deputy Director-General. Foreign Affairs Office. Shanghai
+
+Municipality. Shanghai. August 19, 1997.
+
+Dr. Hio Rio Yin. Vice Director. Development and Research Centre. Shanghai Stock
+
+Exchange. Shanghai. August 20, 1997.
+
+Gu Ying. Business Manager. Projects and Foreign Affairs Department.
+
+Administrative Committee Xi’an High-Tech Industries Development Zone.
+Xi’an. August 15, 1997.
+
+Zhang Dongfan. Vice Executive Director. The Administrative Committee on Xi’an
+
+High-Tech Industries Zone. Xi’an. August 15, 1997.
+
+Zhang Yuejiao. Director General. Department of Treaty and Law. Ministry of
+
+Foreign Trade and Economic Cooperation. Beijing. August 13, 1997. 
+
+George Yuen. Chief Executive. The Better Hong Kong Foundation. Hong Kong.
+
+August 22, 1997.
+
+Shirley Zhao. Sales and Marketing. Shanghai (Z.J.) Hi-Tech Park. Shanghai. August
+
+1997.
+
+Daniel C. Zhou. Accident and Health Manager. AIG/AIA. Shanghai. August 19,
+
+1997.
+
+ CRS Publications 
+
+(name redacted), (name redacted), 
+
+Jonathan Medalia, and Dianne Rennack.
+
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+1998.
+
+(name redacted). 
+
+ Trade Statistics of the United States: Merchandise Trade, 
+
+ 1948-96, and 1997 Estimate. CRS Report 97-420. December 8, 1997.
+
+(name redacted). Hong Kong’s 1998 Electoral Reforms. CRS Report 97-822.
+
+September 8, 1997.
+
+(name redacted). China’s Treatment of Religious Practices. CRS Report 97-882.
+
+Updated September 25, 1997.
+
+ 
+ CRS-28
+
+(name redacted). Hong Kong’s “Provisional Legislature” Controversy. CRS
+
+Report 97-557. May 21, 1997.
+
+(name redacted) and Patricia Nugent. China-U.S. Relations: Chronology of 
+
+ Developments During the Clinton Administration. CRS Report 97-484. April
+22, 1997.
+
+(name redacted). Telecom Services: The WTO Agreement. CRS Report 98-165.
+
+February 26, 1998.
+
+Angele Gilroy and Lisa Randall. International Telecommunications Service Markets: 
+
+ Liberalization and Privatization. CRS Report 96-848. September 30, 1996.
+
+(name redacted). 
+
+ China’s Economic Future, 2010 and 2020. CRS Report 97-246.
+
+Updated April 17, 1997.
+
+George Holliday. China’s Application to the World Trade Organization: Are Chinese 
+
+ Economic Reforms Sufficient? CRS Report 96-857. October 28, 1996.
+
+(name redacted). China: Possible Missile Technology Transfers From U.S. Satellite 
+
+ Export Policy—Background and Chronology. CRS Report 97-850. May 20,
+1998.
+
+(name redacted), coordinator. 
+
+ International Science and Technology Issues: 
+
+ Summary of a Report to the Committee on Science. CRS Report 98-353. March
+23, 1998. 
+
+(name redacted). 
+
+ China’s Economic Conditions. IB98014. Updated regularly.
+
+(name redacted). 
+
+ Most-Favored-Nation Status and China: History and 
+
+ Alternative Approaches to Current Law. CRS Report 96-992. December 10,
+1997.
+
+(name redacted). 
+
+ Most-Favored-Nation Policy of the United States. IB93107.
+
+Updated regularly.
+
+Diane E. Rennack. China: U.S. Economic Sanction s. CRS Report 96-272. Updated
+
+October 1, 1997.
+
+Jonathan Sanford. China and the Multilateral Development Banks. CRS Report 97-
+
+518. Updated October 31, 1997.
+
+(name redacted). China’s Space Program: A Brief Overview Including Commercial 
+
+ Launches of U.S.-Built Satellites. CRS Report 98-575. June 23, 1998. 15 pages.
+
+(name redacted). Space Launch Vehicles: Government Requirements and 
+
+ Commercial Competition. CRS Report IB93062. [updated regularly] 
+
+(name redacted) a nd Peter Mitchener. China: Interest Groups and Recent U.S. 
+
+ Policy—An Introduction. CRS Report 97-48. December 30, 1997. 
+
+ 
+ CRS-29
+
+(name redacted). China-Southeast Asia Relations: Trends, Issues, and Implications 
+
+ for the United States. CRS Report 97-553. May 20, 1997.
+
+(name redacted). Sanitary and Phytosanitary Standards for Foods in the GATT 
+
+ Uruguay Round Accords. CRS Report 94-512. June 21, 1994. 
+
+ Other Sources 
+
+J.D. Brown. “Chinese City in Transition.” The New York Times. March 14, 1995.
+
+Bruce Einhorn. “Hong Kong: Now the Rule of Law is in Jeopardy.” BusinessWeek. 
+
+April 20, 1998: 62. 
+
+Seymour Goodman, Peter Walcott, and Patrick Homer. High-performance computing 
+
+ National Security Applications, and Export Control Policy at the Close of the
+20th Century. [Working paper] U.S. Department of Commerce. May 4, 1998.
+200 pages. 
+
+Elaine Sciolino and Jeff Gerth. “Scientist Who Led Missile Review Promised to
+
+Help China.” The New York Times. June 6, 1998. Http://www.nytimes.com.
+
+Gerald F. Seib. “When It’s China, Watch Actions Not the Words.” The Wall Street 
+
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+
+Robert L. Worden, Andrea Matles Savada, and Robert E. Dolan, editors. China: A 
+
+ Country in Study . Federal Research Division. U.S. Library of Congress.
+Research completed July 1987. 432 pages.
+
+U.S. General Accounting Office. Export Controls: Change in Export Licensing
+
+Jurisdiction for Two Sensitive Dual-Use Items. GAO/NSIAD-97-24. January
+1997. 27 pages.
+
+—— Export Controls: Sale of Telecommunications Equipment to China.
+
+GAO/NSIAD-97-5. November 1996. 16 pages. 
+
+—— Export Controls: Some Controls Over Missile-Related Technology Exports to
+
+China are Weak. GAO/NSIAD-95-82. April 1995. 29 pages.
+
+ 
+ EveryCRSReport.com
+
+The Congressional Research Service (CRS) is a federal legislative branch agency, housed inside the 
+Library of Congress, charged with providing the United States Congress non-partisan advice on 
+
+issues that may come before Congress.
+
+EveryCRSReport.com republishes CRS reports that are available to al Congressional staff. The 
+reports are not classified, and Members of Congress routinely make individual reports available to 
+the public. 
+
+Prior to our republication, we redacted names, phone numbers and email addresses of analysts 
+who produced the reports. We also added this page to the report. We have not intentional y made 
+any other changes to any report published on EveryCRSReport.com.
+
+CRS reports, as a work of the United States government, are not subject to copyright protection in 
+the United States. Any CRS report may be reproduced and distributed in its entirety without 
+permission from CRS. However, as a CRS report may include copyrighted images or material from a 
+third party, you may need to obtain permission of the copyright holder if you wish to copy or 
+otherwise use copyrighted material.
+
+Information in a CRS report should not be relied upon for purposes other than public 
+understanding of information that has been provided by CRS to members of Congress in 
+connection with CRS' institutional role.
+
+EveryCRSReport.com is not a government website and is not affiliated with CRS. We do not claim 
+copyright on any CRS report we have republished.
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diff --git a/corpus/politics/text/fc249aef7d2106d3.txt b/corpus/politics/text/fc249aef7d2106d3.txt
new file mode 100644
index 0000000000000000000000000000000000000000..ed868c0aa9b900ffb0947ba10d1a126df3bed95a
--- /dev/null
+++ b/corpus/politics/text/fc249aef7d2106d3.txt
@@ -0,0 +1,252 @@
+INSIGHTi 
+
+ 
+
+ FY2024 NDAA: Department of Defense 
+Acquisition Policy 
+
+August 17, 2023 
+
+ Introduction 
+ The Defense Acquisition System (DAS) is the process through which the U.S. Department of Defense 
+(DOD) develops and buys goods and services from contractors. The process is base d on statute and 
+ regulation. The process involves numerous activities, including design, engineering, construction, testing, 
+deployment, sustainment, and disposal of items purchased from a contractor. This product provides an 
+overview of selected acquisition-related provisions in the House- and Senate-passed versions of a 
+National Defense Authorization Act for Fiscal Year 2024 (NDAA; H.R. 2670 a nd S. 2226). For more 
+background on defense acquisitions, see CRS Report R L34026, Defense Acquisitions: How DOD 
+Acquires Weapon Systems and Recent Efforts to Reform the Process . 
+
+ Legislative Proposals 
+ Congress may incorporate provisions related to the defense acquisition process or individual acquisition 
+programs in multiple titles in an NDAA. A recurring NDAA title (i.e., Title VIII of Division A) typically 
+addresses acquisition policy, acquisition management, and related matters. In general, Congress uses the 
+NDAA to establish or disestablish, amend, or direct study of elements of and processes related to defense 
+acquisitions. For example, t he FY2022 NDAA established a commission to study the effectiveness of the 
+department’s Planning, Programming, Budgeting, and Execution (PPBE)— an internal strategic planning 
+process for allocating resources among the military departments, defense agencies, and other components. 
+
+The House and Senate-passed versions of an FY2024 NDAA include multiple proposals pertaining to 
+acquisition policy, including those related to capability development, DOD contracting, and mitigating 
+foreign influence over DOD contractors. Table 1 below summarizes selected provisions from H.R. 2670 
+ and S. 2226. 
+
+ Table 1. Selected Acquisition Policy Proposals in the FY2024 NDAA Bills 
+
+ House-Passed H.R. 2670 
+
+ Senate-Passed S. 2226 
+
+ Proposals Related to DOD’s Capability Development Process 
+
+ Congressional Research Service 
+
+https://crsreports.congress.gov 
+
+IN12225 
+
+ CRS INSIGHT 
+ Prepared for Members and 
+
+ Committees of Congress 
+
+ 
+
+ 
+
+ 
+
+ 
+ Congressional Research Service 
+
+2 
+
+ House-Passed H.R. 2670 
+
+ Senate-Passed S. 2226 
+
+No similar provision. 
+
+ Sec. 802 would require DOD to develop a more 
+“streamlined” and modernized capability development 
+
+requirements process, aligned with th e Adaptive Acquisition 
+Framework, by 2025. 
+
+ Sec. 803 would require the military services to designate a 
+
+No similar provision. 
+
+“Principal Transition Advisor” to support service secretaries 
+with the transition of new technologies from research and 
+development to fielding. This would include interfacing with 
+relevant DOD innovation organizations and program 
+managers. 
+
+No similar provision. 
+
+ Sec. 803 would give the Director of the Strategic 
+Capabilities Office (SCO) the authority to conduct 
+acquisition activities, including the authority to negotiate 
+memoranda of agreement with DOD components and 
+military departments to procure capabilities, equipment, and 
+services on behalf of SCO. 
+
+ Sec. 851 would require DOD to launch a pilot program to 
+
+No similar provision. 
+
+conduct competitions to procure and field “attritable 
+systems that solve urgent operational needs.” 
+
+No similar provision. 
+
+ Sec. 811 would give Combatant Commanders rapid and 
+streamlined contracting authorities for certain time-sensitive 
+and urgent situations. 
+
+ Proposals Related to DOD Contracting 
+
+ Sec. 804 would require DOD to launch a pilot program to 
+
+No similar provision. 
+
+determine whether certain contractors that unsuccessful y 
+protest a contract bid loss should be required to reimburse 
+DOD for the costs to the government of conducting the 
+protest. 
+
+No similar provision. 
+
+ Sec. 806 would require a DOD study on the feasibility and 
+advisability of establishing a default commercial 
+determination for the products and services acquired by 
+DOD. 
+
+No similar provision. 
+
+ Sec. 815 would exempt all software contracts and 
+subcontracts fro m Earned Value Management (EVM) 
+requirements in the Defense Federal Acquisition Regulation 
+Supplement (DFARS), and would raise the dol ar threshold 
+for EVM requirements. 
+
+No similar provision. 
+
+ Sec. 817 would require DOD to launch a pilot program 
+providing high er progress payment rates to incentivize 
+contractors to meet certain criteria, including meeting small 
+business subcontracting goals and adhering to delivery 
+schedule. 
+
+ 
+
+ Sec. 844 would amend th e Small Business Act to provide 
+measures to encourage DOD contractors to provide more 
+timely payments to subcontractors. 
+
+ Proposals Related to Mitigating Foreign Influence in DOD Contracting 
+
+ 
+
+ 
+ Congressional Research Service 
+
+3 
+
+ House-Passed H.R. 2670 
+
+ Senate-Passed S. 2226 
+
+ Sec. 808 would require contractors providing consulting 
+
+ Sec 812 would amen d P.L. 113-291; 1 0 11 U.S.C. 4871 to 
+
+services to DOD to disclose any previous contracts or 
+
+add additional restrictions and procedures for preventing 
+
+financial awards from covered entities, including entities with covered persons or entities from contracting with DOD. 
+
+connections to the governments of the People’s Republic of 
+
+ 
+
+China or the Russian Federation, as well as several entity 
+lists maintained by the Department of Commerce. 
+
+ Sec. 819 would increase DOD requirements to confirm that 
+contractors do not have conflicts of interest, including 
+contracts, with covered foreign entities, including entities 
+with connections to the governments of the People’s 
+Republic of China or the Russian Federation. Contractors 
+found to have conflicts of interest with covered entities 
+would be subject to additional surveillance. 
+
+ Source: CRS analysis of legislation on Congress.gov 
+
+ Discussion 
+
+ Proposals Related to DOD’s Capability Development Process 
+
+ Some defense experts and policymakers have argued for a need for DOD to improve and/or accelerate its 
+acquisition processes for new, innovative technologies. 
+
+Several provisions in the proposed versions of an FY2024 NDAA aim to modify acquisition processes, 
+delegate authorities and responsibilities, and create new organizations to improve both how DOD 
+develops capabilities and the speed at which such capabilities are developed and fielded. 
+
+ Proposals Related to DOD Contracting 
+
+DOD contracting is a longstanding issue of interest for Congress . Media coverage in 2023 concerning 
+ DOD contract pricing and subcontractor cash flow has generated congressional interest in the topic. 
+
+The versions of an FY2024 NDAA contains several provisions related to DOD contractor transparency 
+and adherence to regulation. 
+
+ Proposals Related to Mitigating Foreign Influence in DOD Contracting 
+ Some Members of Congress have expressed interest in preventing adversarial governments from having 
+financial and other ties to DOD contractors, particularly after DOD identified China as the “pacing 
+challenge” (i.e., the challenge against which to “pace” armed forces development) as well as department 
+ efforts to prevent foreign ownership, control, and influence (FOCI) in its supply chain. 
+ 
+Such interest is reflected in proposed FY2024 NDAA provisions that would increase reporting 
+requirements regarding FOCI and increase restrictions on contractors found to have FOCI risk. 
+
+ 
+
+ 
+ Congressional Research Service 
+
+4 
+
+ Author Information 
+
+ 
+Alexandra G. Neenan 
+
+ 
+
+Analyst in U.S. Defense Infrastructure Policy 
+ 
+
+ 
+
+ 
+
+ 
+
+ Disclaimer 
+
+This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff 
+to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of 
+Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of 
+information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role. 
+CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United 
+States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However, 
+as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the 
+permission of the copyright holder if you wish to copy or otherwise use copyrighted material. 
+
+ 
+
+IN12225 · VERSION 1 · NEW
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