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Covariate-constrained randomization in cluster randomized 2 × 2 factorial trials: application to a diabetes prevention study.

Juned SiddiqueZhehui LiMatthew J O'Brien
Published in: Trials (2024)
CR should be used instead of simple randomization when performing factorial CRTs to avoid highly imbalanced designs and to obtain more precise inferences. Except when there are a small number of clusters, cluster-level covariates should be included in the analysis model to increase power and maintain coverage and type 1 error rates at their nominal levels.
Keyphrases
  • type diabetes
  • cardiovascular disease
  • open label
  • phase iii
  • glycemic control
  • clinical trial
  • healthcare
  • randomized controlled trial
  • phase ii
  • metabolic syndrome