Constrained randomization and statistical inference for multi-arm parallel cluster randomized controlled trials.

ABSTRACT: A practical limitation of cluster randomized controlled trials (cRCTs) is that the number of available clusters may be small, resulting in an increased risk of baseline imbalance under simple randomization. Constrained randomization overcomes this issue by restricting the allocation to a subset of randomization schemes where sufficient overall covariate balance across comparison arms is achieved. However, for multi-arm cRCTs, several design and analysis issues pertaining to constrained randomization have not been fully investigated. Motivated by an ongoing multi-arm cRCT, we elaborate the method of constrained randomization and provide a comprehensive evaluation of the statistical properties of model-based and randomization-based tests under both simple and constrained randomization design

SUBMITTER: Zhou Y 

PROVIDER: S-EPMC9007899 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature