PASSReviewer 1· 85% conf
The cluster-randomized design is well-described with adequate randomization, sample size calculation, and pre-specified analysis.
Evidence
paraphrase[Methods, Study Design]
“To ensure random but geographically balanced allocation of clusters that were similarly representative of rural and urban communities and that were included in the ongoing hospital-based pediatric ARI surveillance, we used automated rejection sampling as previously described.”direct quote[Methods, Statistical Analyses]
“Sample size calculations deemed that with six clusters per intervention arm and 60 infants recruited per cluster we would have >80% power under a type I error probability of 5% to detect a at least five percentage point higher VTs carriage between a reduced dose arms/schedule and a three-dose arm/schedule with an assumed residual VTs carriage prevalence of 5%.”direct quote[Methods, Study Design]
“An open-label, non-inferiority, cluster randomized trial, was conducted across the 27 communes of Nha Trang city, south-central Vietnam.”PASSReviewer 2· 85% conf
The cluster-randomized design is well-described with adequate randomization, sample size calculation, and pre-specified analysis.
Evidence
direct quote[Methods, Study Design]
“we used automated rejection sampling as previously described”direct quote[Methods, Statistical Analyses]
“Sample size calculations deemed that with six clusters per intervention arm and 60 infants recruited per cluster we would have >80% power under a type I error probability of 5% to detect a at least five percentage point higher VTs carriage”direct quote[Methods, Study Design]
“An open-label, non-inferiority, cluster randomized trial”