Planning stepped wedge cluster randomized trials to detect treatment effect heterogeneity.

ABSTRACT: Stepped wedge design is a popular research design that enables a rigorous evaluation of candidate interventions by using a staggered cluster randomization strategy. While analytical methods were developed for designing stepped wedge trials, the prior focus has been solely on testing for the average treatment effect. With a growing interest on formal evaluation of the heterogeneity of treatment effects across patient subpopulations, trial planning efforts need appropriate methods to accurately identify sample sizes or design configurations that can generate evidence for both the average treatment effect and variations in subgroup treatment effects. To fill in that important gap, this article derives novel variance formulas for confirmatory analyses of treatment effect heterogeneity, that ar

SUBMITTER: Li F 

PROVIDER: S-EPMC12036261 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature