Interim data monitoring in cluster randomised trials: Practical issues and a case study.

ABSTRACT:

Background

There is an abundance of guidance for the interim monitoring of individually randomised trials. While methodological literature exists on how to extend these methods to cluster randomised trials, there is little guidance on practical implementation. Cluster trials have many features which make their monitoring needs different. We outline the methodological and practical challenges of interim monitoring of cluster trials; and apply these considerations to a case study.

Case study

The E-MOTIVE study is an 80-cluster randomised trial of a bundle of interventions to treat postpartum haemorrhage. The proposed data monitoring plan includes (1) monitor sample size assumptions, (2) monitor for evidence of selection bias, and (3) an interim assessment of the primary outcom

SUBMITTER: Hemming K 

PROVIDER: S-EPMC8479148 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature