The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

Abstract

The stepped wedge cluster randomised controlled trial is a relatively new study design that is increasing in popularity. It is an alternative to parallel cluster trial designs, which are commonly used for the evaluation of service delivery or policy interventions delivered at the level of the cluster. The design includes an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals (the "steps") one cluster (or a group of clusters) is randomised to cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Data collection continues throughout the study, so that each cluster contributes observations under both control and intervention observation periods. It is a pragmatic study design, giving great potential for robust scientific evaluations that might otherwise not be possible.