阶梯设计方法及其在中医临床研究中的应用

Stepped Wedge Design Methodology and Its Application in Chinese Medicine Clinical Trials

阶梯设计是一种特殊的群组随机对照试验,其主要特点是分阶段实施干预,不用设置专门的对照组,既做到了平行随机对照,又避免了伦理学问题。近10年来,该方法逐渐被研究者关注,相关理论也趋于完善。介绍该方法在设计、实施和统计分析方面的要点,提出对艾滋病、结核病、肝炎等慢性疾病的中医药治疗及管理等方面的临床研究具有借鉴意义的阶梯设计。

Stepped wedge design is a special group randomized controlled trial, and its main feature is phased implementation of intervention without setting specific controlled group. This methodology could achieve parallel randomized controlling, and also avoid ethical problems. In the recent decade, this design method is attracting researchers＇ concern, and the relative theory is becoming complete. This article introduces the key points in designing, implementing and statistical analysis, and proposes the stepped wedge design which could be used in Chinese medicine treating and managing chronic diseases, including acquired immune deficiency syndrome, tuberculosis, and hepatitis.