Watson Samuel I, Hooper Richard
Department of Applied Health Sciences, University of Birmingham, Birmingham, UK
Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
BMJ Qual Saf. 2025 Aug 18;34(9):631-636. doi: 10.1136/bmjqs-2025-018697.
The stepped-wedge cluster randomised trial is a popular design in implementation and health services research. All clusters, such as clinics or hospitals, start in the control state, and gradually switch over to treatment in a random order until all clusters have received the intervention. The design allows for the incorporation of an experiment into the gradual roll-out of an intervention across clusters. However, the traditional stepped-wedge layout may not be the best choice in many scenarios. In this article, we discuss modifications to the stepped-wedge design that maintain a staggered roll-out, but which may improve some key characteristics. We consider improving the timing of implementation periods, reducing the volume of data collection and allowing for the recruitment of clusters over the course of the trial.
阶梯楔形整群随机试验是实施研究和卫生服务研究中一种常用的设计。所有群组，如诊所或医院，均从对照状态开始，然后以随机顺序逐步转换为治疗状态，直至所有群组都接受了干预。这种设计允许在跨群组逐步推广干预措施的过程中纳入一项实验。然而，传统的阶梯楔形布局在许多情况下可能并非最佳选择。在本文中，我们讨论了对阶梯楔形设计的修改，这些修改在保持交错推广的同时，可能会改善一些关键特性。我们考虑改善实施期的时间安排，减少数据收集量，并允许在试验过程中招募群组。
