阶梯设计试验研究方法及报告规范

Method and reporting guideline for stepped-wedge trials

阶梯设计是在服务提供和政策评估领域出现的一种新兴的整群随机对照试验设计,近年来逐渐受到医疗卫生领域研究者的重视。阶梯设计试验不需要设置专门的对照组,在资源有限只能分步实施干预的情况下仍保持传统随机对照试验的优势。本文从基本原理、适用情况、特点、设计类型、数据统计分析方法和相关报告规范等方面对阶梯设计试验进行了综述,旨在为更好地开展阶梯设计试验提供参考并准确评估服务项目在真实世界的实际效果。

Stepped-wedge trial is an emerging cluster randomized controlled trial in the field of service provision and policy evaluation,which is becoming increasingly popular among health care researchers in recent years.There is no need to set up a special control group for stepped-wedge trials,and the advantage of traditional randomized controlled trial is still maintained in the case that the intervention can only be carried out step by step due to limited research resources.In the study,we reviewed the rationale,applicable conditions,characteristics,design types,statistical analysis methods,and relevant reporting guidelines of stepped-wedge trials for providing a reference to quality improvement in stepped-wedge trials and accurate evaluation on health service in real practice.