Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables in cluster-randomized trials.

ABSTRACT: Covariate constrained randomization (CCR) is a method of controlling imbalance in important baseline covariates in cluster-randomized trials (CRT). We use simulated CRTs to investigate the performance (control of imbalance) of CCR relative to simple randomization (SR) under conditions of misspecification of the cluster-level variable used in the CCR algorithm. We use data from a Patient-Centered Outcomes Research Institute (PCORI)-funded CRT evaluating the Mothers and Babies (MB) intervention (AD-1507-31,473). CCR methodology was used in the MB study to control imbalance in, among other baseline variables, the percent minority (i.e., non-White) participants at each study site. Simulation schemes explored variation in degree of misspecification in the baseline covariate of interest, and inc

SUBMITTER: Organ M 

PROVIDER: S-EPMC7941091 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature