中国循证医学杂志

中国循证医学杂志

核心指标集研制规范(COS-STAD)介绍及其在中医药领域应用的思考

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核心指标集(Core Outcome Set,COS)是解决临床研究中结局指标不一致、不实用、发表偏倚等问题的重要途径。为保障 COS 研制过程的规范化,COMET 工作组制定了核心指标集研制规范(Core Outcome Set-STAndards for Development,COS-STAD)。该规范包含 11 条最低标准,涉及三个重要共性环节:应用范围、利益相关者及共识过程。COS-STAD 不仅适用于 COS 研制者规范研究设计,也可用于 COS 使用者判断某个 COS 的方法学质量。本文结合我国临床实践和临床试验的背景和条件,特别是中医药 COS 研制的特点,对 COS-STAD 推荐进行解读,为我国临床试验 COS 研究者和实施者提供参考。

Core Outcome Set (COS) is an important approach to address problems in which the outcomes are inconsistent, non-essential and reporting biased in clinical researches. In order to ensure the standardization of the COS development process, the Core Outcome Measures in Effectiveness Trials (COMET) has initiatively developed the Core Outcome Set-STAndards for Development (COS-STAD). The recommendation includes 11 minimum standards, involving 3 common key domains: the scope, the stakeholders, and the consensus process. The COS-STAD is used by COS developers for standardizing research design, determining the quality of the methodology to develop a COS. Based on the background and conditions of clinical practice and clinical trials in China, especially the characteristics of the development of Core Outcome Set of Traditional Chinese Medicine (TCM-COS), this paper interprets the recommendations of COS-STAD, providing a reference for the potential users of COS in China.

关键词: 核心指标集研制规范(COS-STAD); 核心指标集; 临床试验; 中医药

Key words: Core Outcome Set-STAndards for Development (COS-STAD); Core Outcome Set; Clinical trial; Tranditional Chinese Medicine

引用本文: 张明妍, 张俊华, 杜亮, 张永刚, 赵宏杰, 冯睿, 王虎城, 胡海殷, 赵梦瑜. 核心指标集研制规范(COS-STAD)介绍及其在中医药领域应用的思考. 中国循证医学杂志, 2018, 18(4): 392-396. doi: 10.7507/1672-2531.201802009 复制

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