阶梯整群随机试验

Stepped Wedge Cluster Randomized Trials

阶梯整群随机试验(stepped wedge cluster randomized trial,SW-CRT)是一种新型的研究设计,通常用于评价整群的服务或政策干预效果。该设计不需要单独设立对照,在设计初始阶段,所有整群均不暴露于干预,随后每一个观察期随机一组整群接受干预,进入干预组,直到所有整群均接受干预。本文从SW-CRT的基本原理、类别、研究设计、样本量计算、统计学方法和报告规范等方面进行介绍,为开展SW-CRT研究提供参考。

The stepped wedge cluster randomized trial(SW-CRT)is a kind of new cluster randomized controlled trial design,mostly applied in the field of service delivery and policy evaluation.No control groups are specifically established in SW-CRTs.At the initial time of SW-CRT,no cluster is exposed to the intervention;whereafter,one random cluster will receive the intervention at regular observation intervals until all the clusters cross to the intervention groups.In this review,we summarized the rationale,types,study design,sample size calculation,statistical methods and the reporting standards of the SW-CRT,to provide reference for carrying out SW-CRTs in the future.