Practical and methodological challenges when conducting a cluster randomized trial: Examples and recommendations

Abstract

The use of cluster randomized trial design to answer research questions is increasing. This design and associated variants such as the cluster randomized crossover and stepped wedge are useful to assess complex interventions in a pragmatic way but when adopting such designs, one may face specific implementation challenges. This article summarizes common challenges faced when conducting cluster randomized trials, cluster randomized crossover trials, and stepped wedge trials, and provides recommendations.

Keywords: Challenges; Cluster randomized trial; Cross-over; Design; Implementation; Methodological recommendations; Stepped-wedge.