PASSReviewer 1· 90% conf
The trial design is rigorous with clear randomization, blinding of laboratory assessments, and a pre-specified statistical analysis plan.
Evidence
direct quote[Methods, Screening and Randomization]
“The statistician in London generated the sequential randomization list, computer-generated using variably-sized permuted blocks. Randomization at sites used consecutively numbered opaque sealed envelopes containing the randomized allocation, opened in numerical order.”direct quote[Methods, Study Procedures and Follow-up]
“Study staff were unblinded throughout; laboratory tests were assayed blinded.”paraphrase[Methods, Statistical Analysis]
“Enrolling 272 children with severe dehydration was anticipated to provide 80% power to detect a 30% relative reduction in 96-hour mortality from 58% in the control group to 41% in the liberal strategies, assuming no lost-to-follow-up by 96hours (2-sided alpha=0.05) .”PASSReviewer 2· 95% conf
The trial design is rigorous: randomization method and unit are described, power analysis is provided, inclusion/exclusion criteria are pre-specified, and the analysis population is defined.
Evidence
direct quote[Methods, Screening and Randomization]
“The statistician in London generated the sequential randomization list, computer-generated using variably-sized permuted blocks. Randomization at sites used consecutively numbered opaque sealed envelopes containing the randomized allocation, opened in numerical order.”paraphrase[Methods, Statistical Analysis]
“Enrolling 272 children with severe dehydration was anticipated to provide 80% power to detect a 30% relative reduction in 96-hour mortality from 58% in the control group to 41% in the liberal strategies, assuming no lost-to-follow-up by 96hours (2-sided alpha=0.05).”direct quote[Methods, Trial Population]
“Eligible children aged 6 months to 12 years hospitalized with SAM (defined as either weight-for-height z-score <-3, mid-upper arm circumference (MUAC) <11.5cm or presentation with edematous malnutrition (kwashiorkor) with at least bilateral pedal edema ) with gastroenteritis (>3 loose stools per day) and signs of severe dehydration were included.”