PASSReviewer 1· 90% conf
The trial design is rigorous with clear randomization, sample size calculation, and pre-specified outcomes, though blinding was not possible (open-label).
Evidence
direct quote[Methods, Randomization]
“Participants were randomly assigned to study groups using a lottery-based allocation procedure over two rounds.”paraphrase[Methods, Sample size (truncated section)]
“we made the assumption of 10 malaria episodes per 100 children per year in the control households, with a projected 30% decrease to seven malaria episodes per 100 children per year in the Star Homes.”direct quote[Discussion, Limitations]
“First, it was not possible to blind the study participants or research assistants to the study group.”PASSReviewer 2· 90% conf
The trial design is rigorous with clear randomization, sample size calculation, and pre-specified outcomes, though blinding was not possible (open-label).
Evidence
direct quote[Methods, Randomization]
“Participants were randomly assigned to study groups using a lottery-based allocation procedure over two rounds. In each village, the names of eligible heads of households were written on slips of paper, each placed in an individual envelope.”direct quote[Methods, Sample size (truncated section)]
“we made the assumption of 10 malaria episodes per 100 children per year in the control households, with a projected 30% decrease to seven malaria episodes per 100 children per year in the Star Homes . To detect this difference with 80% statistical power and a 5% significance level, we determined that 105 households with three child-years of observation each would be required per group.”direct quote[Discussion, Limitations]
“First, it was not possible to blind the study participants or research assistants to the study group.”