Characterisation of between-cluster heterogeneity in malaria cluster randomised trials to inform future sample size calculations.

ABSTRACT: Cluster randomised trials (CRTs) are important tools for evaluating the community-wide effect of malaria interventions. During the design stage, CRT sample sizes need to be inflated to account for the cluster heterogeneity in measured outcomes. The coefficient of variation (k), a measure of such heterogeneity, is typically used in malaria CRTs yet is often predicted without prior data. Underestimation of k decreases study power, thus increases the probability of generating null results. In this meta-analysis of cluster-summary data from 24 malaria CRTs, we calculate true prevalence and incidence k values using methods-of-moments and regression modelling approaches. Using random effects regression modelling, we investigate the impact of empirical k values on original trial power and explore

SUBMITTER: Biggs J 

PROVIDER: S-EPMC12274344 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature