Analysis methods for covariate-constrained cluster randomized trials with time-to-event outcomes.

ABSTRACT:

Background

Cluster randomized trials, which often enroll a small number of clusters, can benefit from constrained randomization, selecting a final randomization scheme from a set of known, balanced randomizations. Previous literature has addressed the suitability of adjusting the analysis for the covariates that were balanced in the design phase when the outcome is continuous or binary. Here we extended this work to time-to-event outcomes by comparing two model-based tests and a newly derived permutation test. A current cluster randomized trial of vector control for the prevention of mosquito-borne disease in children in Mexico is used as a motivating example.

Methods

We assessed type I error rates and power between simple randomization and constrained randomization using bo

SUBMITTER: Crisp AM 

PROVIDER: S-EPMC11753003 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature