Use of the stepped wedge design cannot be recommended: A critical appraisal and comparison with the classic cluster randomized controlled trial design

摘要

In a conventional randomized controlled trial (RCT), participants are randomly allocated to either an intervention or a control/comparison condition. However, for certain types of interventions, it is not valid to randomize participants at an individual level because contamination between the intervention and control groups can occur. In those situations, an alternative approach is to randomize entire groups of participants (clusters) to the two conditions. Studies using this type of design are typically called cluster RCTs.