有效性试验核心结局指标（Core Outcome Measures in Effectiveness Trials，COMET）小组为推动核心指标集（Core Outcome Set，COS）研究的规范化，发布了核心指标集报告规范（Core Outcome Set-STAndards for Reporting，COS-STAR）和核心指标集研究研制规范（Core Outcome Set-STAndards for Development，COS-STAD）。2019年COMET工作组发布了核心指标集标准方案声明（Core Outcome Set-STAndardised Protocol Items：COS-STAP statement），用以指导研究方案的规范化。COS-STAP声明包括6个主题、13个条目。本文对COS-STAP声明相关条目进行解读，并就中医药核心指标集研究方案需要重视的问题，进行简要分析，以期为核心指标集方案制定提供参考。

The Core Outcome Measures in Effectiveness Trials (COMET) group published the Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-Standards for Development (COS-STAD) to promote the standardization of Core Outcome Set (COS) research. In 2019, the COMET Working Group released the Core Outcome Set-STAndardised Protocol Items: COS-STAP statement. The COS-STAP statement includes 6 main topics, with a checklist of 13 items. In this paper, we interpret the COS-STAP statement and briefly analyze the issues that need to be taken into account in COS research protocols to provide reference for the development of core outcome sets for traditional Chinese Medicine (COS-TCM).

R2-03

国家自然科学基金委员会资助项目（81473544）：中医药临床试验核心指标集(COS-TCM）构建方法研究，负责人：张俊华。