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values | intended_interventions_reasoning stringclasses 57
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a6f07aad-d8d3-4020-9b2f-574c49834601 | 10.1097/HJH.0b013e328334c126 | # Riboflavin lowers blood pressure in cardiovascular disease patients homozygous for the $677 \mathrm{C} \rightarrow \mathrm{T}$ polymorphism in MTHFR
Geraldine Horigana, Helene McNultya, Mary Warda, J.J. Straina, John Purvisb and John M. Scottc
Objective The purpose was to examine the effect of intervention with r... | Systolic blood pressure | Low risk of bias | No information about allocation concealment, but a statement that the study is randomised. We judged that the allocation sequence was probably concealed until participants were enrolled and assigned to the intervention. There was no information on baseline differences between the groups – a table of baseline characteri... | High risk of bias | Excluded 18 participants from the analyses after randomisation (including 2 outliers). | High risk of bias | BP data was presented for 179 of 197 participants (91%). Data excluded from 2 participants because their values for BP were outliers. Data also excluded from 16 other paritipcnats for a variety of resaons, the most common being 'not contactable or withdrew voluntaryily' (n=7). | Low risk of bias | BP measured in standard way (two separate measurements taken 15 min apart with patient at rest). Outcome assessor was blinded to intervention status. | Some concerns | No information about whether data were analysed in accordance with a pre-specified analysis plan that was finalised before unblinded outcome data were available. | High risk of bias |
b4f4d777-2b63-4252-a76f-40fbf01244da | 10.1212/wnl.50.2.466 | # Effectiveness of high-dose riboflavin in migraine prophylaxis
A randomized controlled trial
J. Schoenen, MD, PhD; J. Jacquy, MD; and M. Lenaerts, MD
Article abstract—A deficit of mitochondrial energy metabolism may play a role in migraine pathogenesis. We found in a previous open study that high-dose riboflavin wa... | Adverse events | Low risk of bias | The allocation sequence was concealed and known only to the pharmacist who prepared the study material. | Low risk of bias | Participants and investigators were blinded and there was no apparent deviations from the intended intervention. | Low risk of bias | 5 people were excluded from the analysis after randomisation out of 55 people randomised. | Low risk of bias | Investigators were blinded to intervention status. | Some concerns | No information about whether data were analysed in accordance with a pre-specified analysis plan that was finalised before unblinded outcome data were available. | Some concerns |
3ce32920-d4f7-4b67-84ef-50330dedd6e8 | 10.1093/eurheartj/ehz745.0428 | P3566
# Ambulatory blood pressure response to riboflavin supplementation in adults with the C677T polymorphism in the folate metabolising enzyme methylenetetrahydrofolate reductase (MTHFR)
M. Ward<sup>1</sup>, C.F. Hughes<sup>1</sup>, A. Mc Mahon<sup>1</sup>, M. Rooney<sup>1</sup>, J.J. Strain<sup>1</sup>, R. Plumb<s... | Systolic blood pressure | High risk of bias | No information about allocation concealment, but a statement that the study is randomised. Large imbalances in sex and moderate differences in BP that were very unlikely to be due to chance, and most likely because only the results from participants with SBP of 125 mmHg or more at baseline were presented. | High risk of bias | Analyses excluded eligible participants who had baseline SBP under 125 mmHg. | High risk of bias | No outcome data was presented for participants who had baseline SBP under 125 mmHg. | Low risk of bias | Trial registry information describes the trial as double-blind (participants and investigators blinded). | High risk of bias | The results from only a subset of participants are presented, which suggests the numerical result may have been selected on the basis of multiple analyses of the data. | High risk of bias |
c1f1f0d8-6e51-4e6d-a36f-a470162f4522 | 10.1161/HYPERTENSIONAHA.111.01047 | # Stratified Treatment of Hypertension
# Blood Pressure in Treated Hypertensive Individuals With the MTHFR 677TT Genotype Is Responsive to Intervention With Riboflavin Findings of a Targeted Randomized Trial
Carol P. Wilson, Helene McNulty, Mary Ward, J.J. Strain, Tom G. Trouton, Birgit A. Hoeft, Peter Weber, Franz F... | Systolic blood pressure | Low risk of bias | No information about allocation concealment, but a statement that the study is randomised. We judged that the allocation sequence was probably concealed until participants were enrolled and assigned to the intervention. There are some differences in baseline characteristics between group, although none are statisticall... | High risk of bias | 4 outliers were removed for BP. | High risk of bias | There were 3 drop outs. In addition data from 4 participants was excluded because their values for BP were outliers. | Low risk of bias | Outcome assessor was blinded to intervention status. | Some concerns | No information about whether data were analysed in accordance with a pre-specified analysis plan that was finalised before unblinded outcome data were available. | High risk of bias |
2ac14668-0317-41e4-b567-daebbd19a146 | 10.1097/HJH.0b013e328334c126 | # Riboflavin lowers blood pressure in cardiovascular disease patients homozygous for the $677 \mathrm{C} \rightarrow \mathrm{T}$ polymorphism in MTHFR
Geraldine Horigana, Helene McNultya, Mary Warda, J.J. Straina, John Purvisb and John M. Scottc
Objective The purpose was to examine the effect of intervention with r... | Diastolic blood pressure | Low risk of bias | No information about allocation concealment, but a statement that the study is randomised. We judged that the allocation sequence was probably concealed until participants were enrolled and assigned to the intervention. There was no information on baseline differences between the groups – a table of baseline characteri... | High risk of bias | Excluded 18 participants from the analyses after randomisation (including 2 outliers). | High risk of bias | BP data was presented for 179 of 197 participants (91%). Data excluded from 2 participants because their values were outliers. Data excluded from 16 other participants for a variety of reasons, the most common being 'not contactable or withdrew voluntarily' (n=7). | Low risk of bias | BP measured in standard way (two separate measurements taken 15 min apart with patient at rest). Outcome assessor was blinded to intervention status. | Some concerns | No information about whether data were analysed in accordance with a pre-specified analysis plan that was finalised before unblinded outcome data were available. | High risk of bias |
6b06eef4-8524-4b97-b1b6-416d9ef15b9b | 10.1161/HYPERTENSIONAHA.111.01047 | # Stratified Treatment of Hypertension
# Blood Pressure in Treated Hypertensive Individuals With the MTHFR 677TT Genotype Is Responsive to Intervention With Riboflavin Findings of a Targeted Randomized Trial
Carol P. Wilson, Helene McNulty, Mary Ward, J.J. Strain, Tom G. Trouton, Birgit A. Hoeft, Peter Weber, Franz F... | Diastolic blood pressure | Low risk of bias | No information about allocation concealment, but a statement that the study is randomised. We judged that the allocation sequence was probably concealed until participants were enrolled and assigned to the intervention. There are some differences in baseline characteristics between group, although none are statisticall... | High risk of bias | 4 outliers were removed for DBP. | High risk of bias | There were 3 drop outs and 4 outliers excluded out of 91 randomised. | Low risk of bias | Outcome assessor was blinded to intervention status. | Some concerns | No information about whether data were analysed in accordance with a pre-specified analysis plan that was finalised before unblinded outcome data were available. | High risk of bias |
831f1327-9019-4db6-b625-26231f7c5533 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
36979232-c25d-43e2-ac00-1a5f7d99677c | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
dc00bdfa-bfd9-4c1f-a981-72237fcf5730 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
d1cae5ac-c6d1-4dfe-bdc9-29c93bc7d775 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
2519c0ea-b8a1-4c7b-98c5-f028c1510d9e | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
fec7b863-e04a-4fc6-bbb2-9c7b91fd8c53 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
71e1b252-cbc1-4fbb-8eea-25365d1c37ef | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
5ccbfa7e-fa67-4513-a0e3-485ca8555343 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
f7b85174-529d-4a32-b2ab-5013115e4f31 | 10.1016/j.healun.2010.11.009 | # Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension
Robyn J. Barst, MD, $^{a}$ Ronald J. Oudiz, MD, $^{b}$ Anthony Beardsworth, MD, $^{c}$ Bruce H. Brundage, $^{d}$ Gerald Simonneau, MD, $^{e}$ Hossein A. Ghofrani, MD, $^{f}$ David P. Sundin, PhD, $^{c}$ ... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
4bf68ede-fefc-4685-8f8f-ecb71b51f8fd | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
787c43c3-e069-4c21-b368-3092cdd2959e | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
f2191f10-9572-42b0-a86b-e52ee30c0ced | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
e160a120-0834-40d1-862b-2bfdc7dc85ab | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Death | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
5473ad8a-93c5-44a0-87ee-165bddff0e76 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Death | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
215778c4-feae-4965-baca-8124860d6e9a | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
536cd7a1-3c05-4737-87d2-8cc268223b41 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Hospitalization | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
1973ce34-32b3-414d-9f05-65e2777038d4 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Hospitalization | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
a41a8f8b-d9aa-49b2-a02b-bef2251543d0 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Hospitalization | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
c3a6ac8e-16eb-46e5-8671-4cc2a79e939f | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
f3253e05-2bc6-467f-9a99-885be4b526a7 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
37eded25-5770-473a-b03b-2a164a4afa0e | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
78992481-fc30-4f17-ac0c-279838910015 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in BDS | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
f6b0d458-add2-4db5-bff3-960f0321f837 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in BDS | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
4c23480e-25d7-471e-a367-eb0d6d49a30c | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | CFB in BDS | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
aa498833-4e35-47e4-9279-b8aaa88eaa31 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
a8321fcc-b8ed-4754-a556-c50ba4a8de73 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | High dropout rates ranging 21% to 29%. | Low risk of bias | null | Low risk of bias | null | High risk of bias |
58f72bde-061f-4e5b-b729-cf61b4a58a2c | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
2f645d90-065d-4b4e-82c5-216cb533b819 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
b59485e4-dba3-42d9-b9d5-109da876cd47 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
6a76f904-0ecd-4272-aa92-381b07a6cd30 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
a7c2b87d-20a0-44cd-8775-ce70988b0595 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
4f03d0e0-b8f3-4567-b15a-f170e5120701 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
99024596-7a2f-49a8-bf7d-ed62d8370bc5 | 10.1056/NEJMoa1413687 | # ORIGINAL ARTICLE
# Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension
N. Galiè, J.A. Barberà, A.E. Frost, H.-A. Ghofrani, M.M. Hoeper, V.V. McLaughlin, A.J. Peacock, G. Simonneau, J.-L. Vachiery, E. Grünig, R.J. Oudiz, A. Vonk-Noordegraaf, R.J. White, C. Blair, H. Gillies, K.L. Miller, J.H... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
121323aa-9760-494a-872d-101ad9f09ea3 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
e146c2a1-161e-42c9-a2f5-97cfbb582ea1 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
61e5a0de-6a6f-4165-95a7-7553be3b398b | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
86a1fd11-d41e-4b8c-9f1b-8d5854df4d71 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
d21fcdfb-51f9-4ce2-a6f7-c516f3633cfb | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
f12fee1b-2e6a-4e63-8d89-2c67bc586047 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
d2487457-fb27-49e2-a4a2-651265490d9f | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
b073f4e9-ec48-4fec-a2b4-befb15e7c58a | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
b2e2c6f2-e969-4a81-9faa-088c32257c6a | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
85971afe-a332-4017-9c7e-cf61087fffeb | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
3fb4a06e-bcd2-45de-9cf6-f01d223058b9 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
172fa207-d2c9-4a9c-b148-3a2fdec7c4a1 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
e209f087-cb99-438f-a52c-ee06db2a0a3c | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
a78ff6f5-c6af-44e9-9fbd-f1cd9854d2b5 | 10.1016/j.jacc.2023.10.045 | # Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
Ekkehard Grünig, MD, $^{a}$ Pavel Jansa, MD, PHD, $^{b}$ Fenling Fan, MD, PHD, $^{c}$ Jako... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
1273437e-3290-4ed4-ad54-3edff678fe4f | 10.1183/13993003.02044-2014 | # Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
Vallerie McLaughlin<sup>1</sup>, Richard N. Channick<sup>2</sup>, Hossein-Ardeschir Ghofrani<sup>3</sup>, Jean-Christophe Lemarie<sup>4</sup>, Robert Naeije<sup>5</sup>, Milton Packer<sup>6</sup>, Rogério Souza<sup>7</sup>, Victor ... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | null | Low risk of bias | null | Low risk of bias | null | High risk of bias |
a4bda677-8653-4243-a804-2469aa379bb3 | 10.1183/13993003.02044-2014 | # Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
Vallerie McLaughlin<sup>1</sup>, Richard N. Channick<sup>2</sup>, Hossein-Ardeschir Ghofrani<sup>3</sup>, Jean-Christophe Lemarie<sup>4</sup>, Robert Naeije<sup>5</sup>, Milton Packer<sup>6</sup>, Rogério Souza<sup>7</sup>, Victor ... | Death | Low risk of bias | null | Low risk of bias | null | High risk of bias | null | Low risk of bias | null | Low risk of bias | null | High risk of bias |
824cb1d2-e50a-4533-ab02-bab4daf14bd4 | 10.1183/13993003.02044-2014 | # Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
Vallerie McLaughlin<sup>1</sup>, Richard N. Channick<sup>2</sup>, Hossein-Ardeschir Ghofrani<sup>3</sup>, Jean-Christophe Lemarie<sup>4</sup>, Robert Naeije<sup>5</sup>, Milton Packer<sup>6</sup>, Rogério Souza<sup>7</sup>, Victor ... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | High risk of bias | null | Low risk of bias | null | Low risk of bias | null | High risk of bias |
6426d552-dde2-4ce8-9c1b-c30dd41ac812 | 10.1183/13993003.02044-2014 | # Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
Vallerie McLaughlin<sup>1</sup>, Richard N. Channick<sup>2</sup>, Hossein-Ardeschir Ghofrani<sup>3</sup>, Jean-Christophe Lemarie<sup>4</sup>, Robert Naeije<sup>5</sup>, Milton Packer<sup>6</sup>, Rogério Souza<sup>7</sup>, Victor ... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
46479345-1cae-46c8-a7d1-5bfb94299b49 | 10.1183/13993003.02044-2014 | # Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension
Vallerie McLaughlin<sup>1</sup>, Richard N. Channick<sup>2</sup>, Hossein-Ardeschir Ghofrani<sup>3</sup>, Jean-Christophe Lemarie<sup>4</sup>, Robert Naeije<sup>5</sup>, Milton Packer<sup>6</sup>, Rogério Souza<sup>7</sup>, Victor ... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
f14d569b-948b-43d9-834a-a3e9d1a981a7 | 10.1016/j.ihj.2021.07.007 | Research Brief
# A randomized, double-blind, placebo-controlled study to evaluate sildenafil, ambrisentan combination therapy in pulmonary hypertension, particularly of Eisenmenger syndrome
Shaadab Mohammed... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
81d2f06b-249f-4217-b250-3b39127cbd4b | 10.1056/NEJMoa1213917 | # ORIGINAL ARTICLE
# Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension
Tomás Pulido, M.D., Igor Adzerikho, M.D., Richard N. Channick, M.D., Marion Delcroix, M.D., Nazzareno Galie, M.D., Hossein-Ardeschir Ghofrani, M.D., Pavel Jansa, M.D., Zhi-Cheng Jing, M.D., Franck-Olivier Le Brun, M.Sc., Sa... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
15d69ffb-8714-49d5-ab9b-8855785263b3 | 10.1056/NEJMoa1213917 | # ORIGINAL ARTICLE
# Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension
Tomás Pulido, M.D., Igor Adzerikho, M.D., Richard N. Channick, M.D., Marion Delcroix, M.D., Nazzareno Galie, M.D., Hossein-Ardeschir Ghofrani, M.D., Pavel Jansa, M.D., Zhi-Cheng Jing, M.D., Franck-Olivier Le Brun, M.Sc., Sa... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
048ccf77-e748-41ba-b605-d4f68b6dd690 | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | Clinical worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
6d0a345e-2e7b-4ba3-821b-59c38fa8fee7 | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
4fe58e6b-17c0-407c-9dec-03fa401e433a | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | Hospitalization | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
2afe98d2-1458-4cd1-a922-2cb9f314b297 | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
9cb13015-a3a0-4050-ab2e-f32640cf649f | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | CFB in BDS | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
b689f144-55dc-4250-9b91-0b13f25962ab | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | WHO FC worsening | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
9a14e419-cf61-4a09-9a1c-93ea9ea57c90 | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | SAE | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
60b7aa77-8654-4ea2-be1b-f4884b1b95e0 | 10.1186/s12872-017-0674-3 | # Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial
Carmine Dario Vizza $^{1*}$ , Pavel Jansa $^{2}$ , Simon Teal $^{3}$ , Theresa Dombi ... | Withdrawal | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
7feffc58-33bd-4df0-93a7-4852757d9398 | 10.1164/rccm.200410-1411OC | # Sildenafil versus Endothelin Receptor Antagonist for Pulmonary Hypertension (SERAPH) Study
Martin R. Wilkins, Gideon A. Paul*, Julian W. Strange*, Nina Tunariu, Wendy Gin-Sing, Winston A. Banya, Mark A. Westwood, Alexander Stefanidis, Leong L. Ng, Dudley J. Pennell, Raad H. Mohiaddin, Petros Nihoyannopoulos, and J. ... | Death | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
25618629-1893-42d2-b4af-b0838c5cf36a | 10.1164/rccm.200410-1411OC | # Sildenafil versus Endothelin Receptor Antagonist for Pulmonary Hypertension (SERAPH) Study
Martin R. Wilkins, Gideon A. Paul*, Julian W. Strange*, Nina Tunariu, Wendy Gin-Sing, Winston A. Banya, Mark A. Westwood, Alexander Stefanidis, Leong L. Ng, Dudley J. Pennell, Raad H. Mohiaddin, Petros Nihoyannopoulos, and J. ... | Hospitalization | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
f25f26fd-ed2b-4231-8f96-9eb3830474f5 | 10.1164/rccm.200410-1411OC | # Sildenafil versus Endothelin Receptor Antagonist for Pulmonary Hypertension (SERAPH) Study
Martin R. Wilkins, Gideon A. Paul*, Julian W. Strange*, Nina Tunariu, Wendy Gin-Sing, Winston A. Banya, Mark A. Westwood, Alexander Stefanidis, Leong L. Ng, Dudley J. Pennell, Raad H. Mohiaddin, Petros Nihoyannopoulos, and J. ... | CFB in 6MWD | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias |
c69acd0c-d3c5-4bd0-b99c-a2ddac20a2f1 | 10.1038/hr.2014.28 | # ORIGINAL ARTICLE
# Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension
Yugang Zhuang $^{1,3}$ , Bojie Jiang $^{1,3}$ , Hui Gao $^{2}$ and Wei Zhao $^{1}$
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral t... | Clinical worsening | Some concerns | The details of the randomization process were not provided. | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Some concerns |
bfcd1bb6-1035-4acd-b383-74bfd080fdd6 | 10.1038/hr.2014.28 | # ORIGINAL ARTICLE
# Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension
Yugang Zhuang $^{1,3}$ , Bojie Jiang $^{1,3}$ , Hui Gao $^{2}$ and Wei Zhao $^{1}$
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral t... | Death | Some concerns | The details of the randomization process were not provided. | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Some concerns |
4ded6329-159b-492b-8ca8-c7df7e0dd290 | 10.1038/hr.2014.28 | # ORIGINAL ARTICLE
# Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension
Yugang Zhuang $^{1,3}$ , Bojie Jiang $^{1,3}$ , Hui Gao $^{2}$ and Wei Zhao $^{1}$
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral t... | Hospitalization | Some concerns | The details of the randomization process were not provided. | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Some concerns |
8f53d311-cad5-4a28-8e50-d76e904f85cd | 10.1038/hr.2014.28 | # ORIGINAL ARTICLE
# Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension
Yugang Zhuang $^{1,3}$ , Bojie Jiang $^{1,3}$ , Hui Gao $^{2}$ and Wei Zhao $^{1}$
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral t... | CFB in 6MWD | Some concerns | The details of the randomization process were not provided. | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Some concerns |
c9af7cfb-7c16-409b-a8d4-b25464d4d145 | 10.1038/hr.2014.28 | # ORIGINAL ARTICLE
# Randomized study of adding tadalafil to existing ambrisentan in pulmonary arterial hypertension
Yugang Zhuang $^{1,3}$ , Bojie Jiang $^{1,3}$ , Hui Gao $^{2}$ and Wei Zhao $^{1}$
This prospective, double-blinded, randomized controlled study aimed to investigate the efficacy and safety of oral t... | WHO FC worsening | Some concerns | The details of the randomization process were not provided. | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Low risk of bias | null | Some concerns |
a3ac814c-4e28-41f7-9579-609c7f3914e4 | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Pre-eclampsia or pregnancy loss at any time after conception | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
291782ba-f88d-4d42-b278-991ca6a9027c | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Pre-eclampsia | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
4f785e7a-5c09-4665-bb19-265785b33862 | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Pregnancy loss at any time after conception | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
65079b43-6fa5-4e04-892a-27de52d12858 | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Maternal death | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
45f0d663-c8be-4436-93a8-171abee6a3d0 | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Maternal death or severe morbidity | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
999f91bb-dbce-4f28-a845-cc445054dcf5 | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Preterm delivery before 37 weeks | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
e898bba8-ec36-472e-9d11-cca4180ae9cb | 10.1016/S0140-6736(18)31818-X | 31818-X/vlm/images/d75bb34d22dc0340315e5f0d5e37cf247ef4f1f64642a670aff1b51da42f567a.jpg)
# Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial
31818-X/v... | Stillbirth | Low risk of bias | "The random allocation sequence was generated centrally at WHO headquarters in Geneva, Switzerland, using computer-generated random numbers in a ratio of 1:1 and in balanced blocks of variable size, stratified by site. " | Low risk of bias | Participants, care providers, and outcome assessors were all masked to group allocation. | Some concerns | There was a high loss to follow up (29% in the calcium group and 28% in the placebo group). | Low risk of bias | This outcome was defined and measured appropriately. | Low risk of bias | Outcomes were prespecified and analysed in accordance with an established plan. | Some concerns |
774bb0c5-b95b-43a1-8067-e1d9365e1445 | 10.1056/NEJM199111143252002. | # CALCIUM SUPPLEMENTATION TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY
JOSE M. BELIZÁN, M.D., JOSE VILLAR, M.D., LAURA GONZALEZ, R.N., LIANA CAMPODONICO, M.Sc., AND EDUARDO BERGEL, B.S.
Abstract Background. Calcium supplementation has been reported to reduce blood pressure in pregnant and nonpregnant women. We unde... | Pre-eclampsia | Low risk of bias | Randomised using a random-sample generator programme. Allocation concealment using numbered,sealed,opaque envelopes. | Low risk of bias | Participants, physicians and nurses were blinded to the intervention. | Low risk of bias | In this study, 7.7% of the placebo groups and 8.8% of the calcium group were lost to follow up. However we are unsure what information was missing and for which outcomes. The analyses was done on an intention to treat basis and the possible percentage of missing data for this outcome is small and balanced between group... | Low risk of bias | Trial authors describe consistent measurement techniques througout the trial that are appropriate for this outcome. Measurement tools were regularly calibrated and measurement techniques were closely monitored. Definition of the outcome was clearly defined and appropriate. | Low risk of bias | Protocol not available as trial co-author has no access to paper records. Numerical result assessed from one outcome measurement. | Low risk of bias |
a8957299-e765-4f50-8be5-e4a13ac52975 | 10.1111/j.1479-828X.1999.tb03434.x | # Occasional Review
# Calcium Supplementation In Nulliparous Women For The Prevention Of Pregnancy-Induced Hypertension, Preeclampsia And Preterm Birth: An Australian Randomized Trial
Caroline A. Crowther<sup>1</sup> FRACOG, Janet E. Hiller<sup>2</sup> PhD, Brian Pridmore<sup>3</sup> FRACOG, Robert Bryce<sup>4</sup> ... | Pre-eclampsia | Low risk of bias | Randomisation schedule set up with stratification made by centre using variable blocks and women were enrolled by telephoning the central randomisation number. | Low risk of bias | All staff and researchers involved were blinded to the intervention and the treatment allocation codes were broken after exploratory data analyses. | Low risk of bias | Data was available for all women and babies. | Low risk of bias | The methods of measurement was appropriate and did not differ between groups. | Low risk of bias | The data was analysed in accordance with a pre-specified analysis plan. The trial was stopped early due to financial constraints and the target sample size was not reached. | Low risk of bias |
4dc7a131-4be6-4346-a37e-475fe07dd763 | 10.1007/978-1-4757-4242-8_38 | # IMPACT OF CALCIUM SUPPLEMENTATION IN THE PRECEDING PREGNANCY ON THE HUMAN MILK CALCIUM CONCENTRATION OF GAMBIAN WOMEN
L.M.A. Jarjou, A. Prentice, and J. Bennett
# 1. INTRODUCTION
Following our detailed studies of human milk calcium concentration, we hypothesized that calcium intake in pregnancy may determine human... | Pre-eclampsia | Some concerns | The senior trial author provided additional information via email. Randomisation was managed by an off-site trial author who was not involved in data collection. “The randomisation was by colour coding (ie 4 groups, 2 for active, 2 for placebo), stratified by the 3 clinics to ensure equal distribution, and in blocks of... | Low risk of bias | This was a double-blinded study. | Low risk of bias | Data was available for most participants. | Low risk of bias | Measurement and definition of the outcome was appropriate. | Low risk of bias | Analysis was prespecified. | Some concerns |
0c11060c-5aca-40a3-8997-204569d8ac0e | 10.1056/NEJM199707103370201 | # The New England Journal of Medicine
© Copyright, 1997, by the Massachusetts Medical Society
VOLUME 337
JULY 10, 1997
NUMBER 2
# TRIAL OF CALCIUM TO PREVENT PREECLAMPSIA
RICHARD J. LEVINE, M.D., JOHN... | Pre-eclampsia | Low risk of bias | "Packages of study tablets were prepared and numbered by the pharmaceutical manufacturer according to a computer-generated simple randomization sequence developed by the study statisticians. The packages were then shipped to the medical centers. On enrollment, each woman was assigned the next numbered package of medica... | Low risk of bias | Personnel were unaware of treatment-group assignments. Review authors assume that women were blinded as they received placebo tablets. | Low risk of bias | "Two hundred fifty-three women (5.5 percent) were lost to follow-up: 132 in the calcium group and 121 in the placebo group." Review authors judged this to be small and balanced between groups. | Low risk of bias | Preeclampsia was defined as pregnancy-associated hypertension and pregnancy-associated proteinuria occurring within seven days of each other. "Pregnancy-associated hypertension was defined as a diastolic blood pressure of 90 mm Hg or greater on two occasions 4 to 168 hours (one week) apart". Proteinuria was measured in... | Low risk of bias | This was a pre-specified outcome. | Low risk of bias |
e1377751-7c83-4077-b5c7-4fbdf50eb210 | 10.1016/0002-9378(90)90669-x | # Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations
Jose Villar, MD,\* and John T. Repke, MDb
Bethesda and Baltimore, Maryland
Results are presented of a randomized, double-blinded controlled clinical trial of calcium supplementation (2.0 gm of elemental calcium as calcium... | Pre-eclampsia | Low risk of bias | Computer generated list of random numbers. Opaque envelopes with the bottles numbered were located at the clinic. | Low risk of bias | In this double-blind trial, tablets of placebo were identical to calcium tablets. | Low risk of bias | There was missing data for this outcome (5/94 in the calcium group and 7/95 in the placebo. Review authors judged this to be small and relatively balanced between groups (5.3% versus 7.4%). | Low risk of bias | Preeclampsia was defined as pregnancy-induced hypertension (Diastolic blood pressure at ≥ 30 weeks >90 or ≥140/90 mmHg ) plus ≥ 300mg proteinuria at >30 weeks. Whilst the study does not specify how measurements were taken, review authors accept that this was likely done in an appropriate and consistent way. | Low risk of bias | Protocol not available as trial co-author has no access to paper records. Numerical result assessed from one outcome measurement. | Low risk of bias |
10a0a5d4-366f-4349-ab01-348165761eeb | 10.1016/j.ajog.2006.01.068 | # Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations
Jose Villar, MD,\* and John T. Repke, MDb
Bethesda and Baltimore, Maryland
Results are presented of a randomized, double-blinded controlled clinical trial of calcium supplementation (2.0 gm of elemental calcium as calcium... | Pre-eclampsia | Low risk of bias | Randomization lists for each site were produced with computer-generated random number blocking to restrict randomization within the strata (country). Consecutively numbered treatment boxes were allocated to each participant. "Complete sets, all of which were identical, were shipped by WHO to centers and kept in a desig... | Low risk of bias | "Randomization codes remained at the WHO Clinical Trial Unit until the time of analysis and were not available to any person until the analyses were completed." | Low risk of bias | "Delivery information was unavailable for 143 women (3.4%) in the calcium group and 155 women (3.7%) in the placebo group; therefore, they did not contribute to the preterm analyses, but the available data were included in the analyses for other outcomes. Thus, 4151 women in the calcium group and 4161 women in the plac... | Low risk of bias | Preeclampsia was defined as de novo hypertension plus new-onset proteinuria, both after gestational week 20. Hypertension was defined as a blood pressure of R140 mm Hg and/or R90 mm Hg (5th Korotkoff sound) that occurred on 2 occasions at least 4 hours to a week apart. Proteinuria was defined qualitatively as >2+ by di... | Low risk of bias | This was a pre-specified outcome. | Low risk of bias |
2cf68576-7126-4690-9be5-8a5c19d6376b | 10.1111/j.1479-828X.1999.tb03434.x | # Occasional Review
# Calcium Supplementation In Nulliparous Women For The Prevention Of Pregnancy-Induced Hypertension, Preeclampsia And Preterm Birth: An Australian Randomized Trial
Caroline A. Crowther<sup>1</sup> FRACOG, Janet E. Hiller<sup>2</sup> PhD, Brian Pridmore<sup>3</sup> FRACOG, Robert Bryce<sup>4</sup> ... | Maternal death | Low risk of bias | Randomisation schedule set up with stratification made by centre using variable blocks and women were enrolled by telephoning the central randomisation number. | Low risk of bias | All staff and researchers involved were blinded to the intervention and the treatment allocation codes were broken after exploratory data analyses. | Low risk of bias | Data was available for all women and babies. | Low risk of bias | The methods of measurement was appropriate and did not differ between groups. | Low risk of bias | The data was analysed in accordance with a pre-specified analysis plan. The trial was stopped early due to financial constraints and the target sample size was not reached. | Low risk of bias |
ced92431-0b86-445f-bd73-63f6cf4c389d | 10.1007/978-1-4757-4242-8_38 | # IMPACT OF CALCIUM SUPPLEMENTATION IN THE PRECEDING PREGNANCY ON THE HUMAN MILK CALCIUM CONCENTRATION OF GAMBIAN WOMEN
L.M.A. Jarjou, A. Prentice, and J. Bennett
# 1. INTRODUCTION
Following our detailed studies of human milk calcium concentration, we hypothesized that calcium intake in pregnancy may determine human... | Maternal death | Some concerns | The senior trial author provided additional information via email. Randomisation was managed by an off-site trial author who was not involved in data collection. “The randomisation was by colour coding (ie 4 groups, 2 for active, 2 for placebo), stratified by the 3 clinics to ensure equal distribution, and in blocks of... | Low risk of bias | This was a double-blinded study. | Low risk of bias | Data was available for most participants. | Low risk of bias | Measurement and definition of the outcome was appropriate. | Low risk of bias | Analysis was prespecified. | Some concerns |
b2043cf4-eb5e-4ff1-aed4-59b72a3a3e54 | 10.1016/j.ajog.2006.01.068 | # Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations
Jose Villar, MD,\* and John T. Repke, MDb
Bethesda and Baltimore, Maryland
Results are presented of a randomized, double-blinded controlled clinical trial of calcium supplementation (2.0 gm of elemental calcium as calcium... | Maternal death | Low risk of bias | Randomization lists for each site were produced with computer-generated random number blocking to restrict randomization within the strata (country). Consecutively numbered treatment boxes were allocated to each participant. "Complete sets, all of which were identical, were shipped by WHO to centers and kept in a desig... | Low risk of bias | "Randomization codes remained at the WHO Clinical Trial Unit until the time of analysis and were not available to any person until the analyses were completed." | Low risk of bias | "Delivery information was unavailable for 143 women (3.4%) in the calcium group and 155 women (3.7%) in the placebo group; therefore, they did not contribute to the preterm analyses, but the available data were included in the analyses for other outcomes. Thus, 4151 women in the calcium group and 4161 women in the plac... | Low risk of bias | One objective method of measuring this method. | Low risk of bias | This was a pre-specified outcome. | Low risk of bias |
6352bd1b-f272-4b81-86df-f69ab6b388c3 | 10.1016/j.ajog.2006.01.068 | # Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations
Jose Villar, MD,\* and John T. Repke, MDb
Bethesda and Baltimore, Maryland
Results are presented of a randomized, double-blinded controlled clinical trial of calcium supplementation (2.0 gm of elemental calcium as calcium... | Maternal death or severe morbidity | Low risk of bias | Randomization lists for each site were produced with computer-generated random number blocking to restrict randomization within the strata (country). Consecutively numbered treatment boxes were allocated to each participant. "Complete sets, all of which were identical, were shipped by WHO to centers and kept in a desig... | Low risk of bias | “Randomization codes remained at the WHO Clinical Trial Unit until the time of analysis and were not available to any person until the analyses were completed.” | Low risk of bias | "Delivery information was unavailable for 143 women (3.4%) in the calcium group and 155 women (3.7%) in the placebo group; therefore, they did not contribute to the preterm analyses, but the available data were included in the analyses for other outcomes. Thus, 4151 women in the calcium group and 4161 women in the plac... | Low risk of bias | This outcome was well defined as "at least 1 of the following: Admission to intensive care or any special care unit, eclampsia, severe preeclampsia, placental abruption, HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome, renal failure, or death. This measure is objective and would not differ be... | Low risk of bias | This was a pre-specified outcome. | Low risk of bias |
6b0c5f60-ac58-46ad-9b67-7bec98d80d4e | 10.1007/978-1-4757-4242-8_38 | # IMPACT OF CALCIUM SUPPLEMENTATION IN THE PRECEDING PREGNANCY ON THE HUMAN MILK CALCIUM CONCENTRATION OF GAMBIAN WOMEN
L.M.A. Jarjou, A. Prentice, and J. Bennett
# 1. INTRODUCTION
Following our detailed studies of human milk calcium concentration, we hypothesized that calcium intake in pregnancy may determine human... | Adverse effects | Some concerns | The senior trial author provided additional information via email. Randomisation was managed by an off-site trial author who was not involved in data collection. “The randomisation was by colour coding (ie 4 groups, 2 for active, 2 for placebo), stratified by the 3 clinics to ensure equal distribution, and in blocks of... | Low risk of bias | This was a double-blinded study. | Low risk of bias | Data was available for most participants. | Low risk of bias | Measurement and definition of the outcome was appropriate. | Low risk of bias | Analysis was prespecified. | Some concerns |
e7c788e4-df1b-4a37-9050-22bee6731884 | 10.1056/NEJM199111143252002. | # CALCIUM SUPPLEMENTATION TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY
JOSE M. BELIZÁN, M.D., JOSE VILLAR, M.D., LAURA GONZALEZ, R.N., LIANA CAMPODONICO, M.Sc., AND EDUARDO BERGEL, B.S.
Abstract Background. Calcium supplementation has been reported to reduce blood pressure in pregnant and nonpregnant women. We unde... | Perinatal loss | Low risk of bias | Randomised using a random-sample generator programme. Allocation concealment using numbered,sealed,opaque envelopes. | Low risk of bias | Participants, physicians and nurses were blinded to the intervention. | Low risk of bias | Information for this outcome was available for 94% of women randomsied in each group. This is a small loss to follow up and is balanced across groups. | Low risk of bias | One objective method of measuring this method. | Low risk of bias | Protocol not available as trial co-author has no access to paper records. Numerical result assessed from one objective outcome measurement. | Low risk of bias |
d3eae99b-71d0-450d-8c01-937ab42ff462 | 10.1111/j.1479-828X.1999.tb03434.x | # Occasional Review
# Calcium Supplementation In Nulliparous Women For The Prevention Of Pregnancy-Induced Hypertension, Preeclampsia And Preterm Birth: An Australian Randomized Trial
Caroline A. Crowther<sup>1</sup> FRACOG, Janet E. Hiller<sup>2</sup> PhD, Brian Pridmore<sup>3</sup> FRACOG, Robert Bryce<sup>4</sup> ... | Perinatal loss | Low risk of bias | Randomisation schedule set up with stratification made by centre using variable blocks and women were enrolled by telephoning the central randomisation number. | Low risk of bias | All staff and researchers involved were blinded to the intervention and the treatment allocation codes were broken after exploratory data analyses. | Low risk of bias | Data was available for all women and babies. | Low risk of bias | The methods of measurement was appropriate and did not differ between groups. | Low risk of bias | The data was analysed in accordance with a pre-specified analysis plan. The trial was stopped early due to financial constraints and the target sample size was not reached. | Low risk of bias |
094f86e6-d1ce-43d7-8ec2-eba6a168e4e8 | 10.1007/978-1-4757-4242-8_38 | # IMPACT OF CALCIUM SUPPLEMENTATION IN THE PRECEDING PREGNANCY ON THE HUMAN MILK CALCIUM CONCENTRATION OF GAMBIAN WOMEN
L.M.A. Jarjou, A. Prentice, and J. Bennett
# 1. INTRODUCTION
Following our detailed studies of human milk calcium concentration, we hypothesized that calcium intake in pregnancy may determine human... | Perinatal loss | Some concerns | The senior trial author provided additional information via email. Randomisation was managed by an off-site trial author who was not involved in data collection. “The randomisation was by colour coding (ie 4 groups, 2 for active, 2 for placebo), stratified by the 3 clinics to ensure equal distribution, and in blocks of... | Low risk of bias | This was a double-blinded study. | Low risk of bias | Data was available for most participants. | Low risk of bias | Measurement and definition of the outcome was appropriate. | Low risk of bias | Analysis was prespecified. | Some concerns |
c28019cc-6e2e-4c3f-ac9f-c183032e15e3 | 10.1056/NEJM199707103370201 | # The New England Journal of Medicine
© Copyright, 1997, by the Massachusetts Medical Society
VOLUME 337
JULY 10, 1997
NUMBER 2
# TRIAL OF CALCIUM TO PREVENT PREECLAMPSIA
RICHARD J. LEVINE, M.D., JOHN... | Perinatal loss | Low risk of bias | "Packages of study tablets were prepared and numbered by the pharmaceutical manufacturer according to a computer-generated simple randomization sequence developed by the study statisticians. The packages were then shipped to the medical centers. On enrollment, each woman was assigned the next numbered package of medica... | Low risk of bias | Personnel were unaware of treatment-group assignments. Review authors assume that women were blinded as they received placebo tablets. | Low risk of bias | "Two hundred fifty-three women (5.5 percent) were lost to follow-up: 132 in the calcium group and 121 in the placebo group." Review authors judged this to be small and balanced between groups. | Low risk of bias | One objective method of measuring this method. | Low risk of bias | This was a pre-specified outcome. | Low risk of bias |
ce4ef540-f09d-4ba7-8828-2227026040eb | 10.1056/NEJM199111143252002. | # CALCIUM SUPPLEMENTATION TO PREVENT HYPERTENSIVE DISORDERS OF PREGNANCY
JOSE M. BELIZÁN, M.D., JOSE VILLAR, M.D., LAURA GONZALEZ, R.N., LIANA CAMPODONICO, M.Sc., AND EDUARDO BERGEL, B.S.
Abstract Background. Calcium supplementation has been reported to reduce blood pressure in pregnant and nonpregnant women. We unde... | Preterm delivery at or before 37 weeks | Low risk of bias | Randomised using a random-sample generator programme. Allocation concealment using numbered,sealed,opaque envelopes. | Low risk of bias | Participants, physicians and nurses were blinded to the intervention. | Low risk of bias | In this study, 7.7% of the placebo groups and 8.8% of the calcium group were lost to follow up. However we are unsure what information was missing and for which outcomes. The analyses was done on an intention to treat basis and the possible percentage of missing data for this outcome is small and balanced between group... | Low risk of bias | O=There is one objective method of measuring this method. | Low risk of bias | Protocol not available as trial author has no access to paper records. Numerical result assessed from one outcome measurement. | Low risk of bias |
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