Abstract
The stepped wedge cluster randomised trial is a novel research study design that is increasingly being used in the evaluation of service delivery type interventions. The design involves random and...
Highlights
In a stepped wedge design more clusters are exposed to the intervention towards the end of the study than in its early stages
This implies that the effect of the intervention might be confounded with any underlying temporal trend
A result that initially might seem suggestive of an effect of the intervention may transpire to be the result of a positive underlying temporal trend
Summary
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. 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. Brief history of the stepped wedge cluster randomised trial The stepped wedge cluster randomised trial has been used across several settings for some years, but early stepped wedge designs were sometimes described in other terms such as “waiting list designs” or “phased
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