PASSReviewer 1· 95% conf
The manuscript is well-reported with detailed methods, trial registration, CONSORT adherence, transparent outcome reporting, limitations discussion, and funding/COI statements.
Evidence
paraphrase[Summary, Methods]
“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov), NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432).”paraphrase[Methods, Study design]
“This trial is reported in accordance with CONSORT guidelines (p 4).”paraphrase[Discussion, paragraph 5]
“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25%... However, we observed lower reductions in mortality rate than were expected... Given the nature of KMC, it was impossible to mask participants and hospital staff...”PASSReviewer 2· 95% conf
The manuscript is transparent: methods are detailed, the trial is registered, CONSORT is followed, all outcomes are reported (including non-significant), limitations are discussed, conclusions are proportional, and funding/COI are disclosed.
Evidence
paraphrase[Abstract and Methods]
“This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov), NCT02811432 (https://clinicaltrials.gov/ct2/show/NCT02811432).”paraphrase[Methods, Study design]
“This trial is reported in accordance with CONSORT guidelines (p 4).”paraphrase[Discussion, paragraph 4]
“This trial also had limitations. Our sample size assumed a baseline mortality rate of 25% … we observed lower reductions in mortality rate than were expected … Given the nature of KMC, it was impossible to mask participants and hospital staff to treatment allocation, but the independent statistician … was masked.”PASSReviewer 3· 90% conf
Reporting is complete: methods are replicable, the trial is registered (NCT02811432), CONSORT and CHEERS guidelines are referenced, all prespecified outcomes are reported, limitations are discussed at length, conclusions are proportional, and funding/COI are declared.
Evidence
paraphrase[Methods, Study design]
“This trial is reported in accordance with CONSORT guidelines ( p 4). The study was approved by the Research Ethics Committees of Uganda Virus Research Institute (GC/127/19/06/717)... This trial is registered with ClinicalTrials.gov (http://Clinicaltrials.gov) , NCT02811432”direct quote[Discussion, paragraph 5]
“Our sample size would have been sufficient to detect an absolute reduction of 4·8% (relative reduction of 26·7%), even with an 18% mortality rate. However, we observed lower reductions in mortality rate than were expected from baseline data in both the control and intervention groups, which reduced our power to detect the prespecified relative reduction of 5·6%.”paraphrase[Acknowledgments / Declaration of interests]
“The OMWaNA trial was supported by a grant from the Joint Global Health Trials scheme... (MR/S004971/1)... Declaration of interests We declare no competing interests.”