中国循证医学杂志

中国循证医学杂志

《COMET 手册 1.0 版》解读及其对构建中医临床研究核心指标集的启示

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核心指标集是指特定疾病/健康领域的临床研究应当报告的最小指标集合。临床研究中使用核心指标集可减少报告同类结局指标研究的异质性,使更多研究结果能纳入系统评价/Meta 分析中进行合并,在一定程度上提高研究的价值和意义,减少研究经费的浪费。近期,“有效性试验核心结局指标测量”(core outcome measures in effectiveness trials,COMET)工作组发布了《COMET 手册 1.0 版》,该手册全面讨论了当前核心指标集研究中存在的问题,并推荐了解决方法。本文对《COMET 手册 1.0 版》进行解读,并结合中医临床研究特色,分析该手册对构建中医临床研究核心指标集的启示,以期给相关研究者提供借鉴。

A core outcome set (COS) is an agreed and minimum set of outcomes that should be measured in all clinical trials in specific areas of health or health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by reducing the risk of outcome reporting bias. It will enhance the value of trials and reduce avoidable investment waste in some extent. Recently, core outcome measures in effectiveness trials (COMET) initiative developed the COMET handbook (version 1.0). This handbook discussed the problems of COS and made recommendations for some of them, which is a good guideline for practice and research. In this paper, some important issues and viewpoints of the handbook were analyzed, meanwhile, the enlightenment of the handbook for the development of COS in clinical trials of traditional Chinese medicine were discussed, which would provide proposal to relative researchers.

关键词: 《COMET 手册》; 核心指标集; 中医; 临床研究

Key words: The COMET handbook; Core outcome set; Traditional Chinese medicine; Clinical trial

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