Stepped Wedge Cluster Randomized Trials: A Methodological Overview.

Abstract

Stepped wedge cluster randomized trials enable rigorous evaluations of health intervention programs in pragmatic settings. In the present study, we aimed to update neurosurgeon scientists on the design of stepped wedge randomized trials. We have presented an overview of recent methodological developments for stepped wedge designs and included an update on the newer associated methodological tools to aid with future study designs. We defined the stepped wedge trial design and reviewed the indications for the design in depth. In addition, key considerations, including mainstream methods of analysis and sample size determination, were discussed. Stepped wedge designs can be attractive for study intervention programs aiming to improve the delivery of patient care, especially when examining a small number of heterogeneous clusters.