Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine

ZHANG Mingyan; LI Kai; CAI Huizi; NIU Bohan; ZHANG Junhua

doi:10.13288/j.11-2166/r.2021.02.005

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Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine

更新时间：2021-11-10

- Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine
- Journal of Traditional Chinese Medicine Vol. 62, Issue 2, Pages: 108-113(2021)
- 作者机构：
  
  天津中医药大学中医药研究院循证医学中心
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2021.02.005
  CLC： R288
- Published：2021
- 稿件说明：
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[1]张明妍,李凯,蔡慧姿,牛柏寒,张俊华.临床试验核心指标集研究发展概况及其在中医药领域的关键问题[J].中医杂志,2021,62(02):108-113.

ZHANG Mingyan, LI Kai, CAI Huizi, et al. Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(2): 108-113.
[1]张明妍,李凯,蔡慧姿,牛柏寒,张俊华.临床试验核心指标集研究发展概况及其在中医药领域的关键问题[J].中医杂志,2021,62(02):108-113. DOI： 10.13288/j.11-2166/r.2021.02.005.

ZHANG Mingyan, LI Kai, CAI Huizi, et al. Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(2): 108-113. DOI： 10.13288/j.11-2166/r.2021.02.005.

摘要

临床研究设计中选择合适的结局指标对评价干预措施的作用至关重要。在同类疾病相关临床试验中建立必须报告的、统一的、标准化的最小指标集合

即核心指标集（COS）

是规范指标使用的关键途径。回顾COS产生背景和发展历程

揭示COS研究的重要意义

并结合实际情况介绍COMET及ChiCOS两大数据库注册平台的各自特点和局限性

对不同数据库平台的合理选择使用进行分析。目前COS研制方法尚不成熟

结合中医药研究的特殊性

阐述了中医药COS研制难点在于原始结局指标需标准化、指标分类之间存在交叉性、广泛征求国际性共识实施困难大、中医药疗效特色指标在COS中体现不足等

以期为我国临床试验COS各利益相关群体提供参考。

Abstract

It is of great significance to select the appropriate outcomes when evaluating the effect of an intervention. The core outcome set（COS） is an agreed and standardized minimum set of outcomes that should be reported in all clinical trials of the same disease

which is key to standardize the use of outcomes. This paper reviewed the background and development history of COS and revealed the importance of COS researches. Based on the actual use experience

the characteristics and limitations of two registry platforms（COMET database and Chicos webpage） were also introduced

and the rational selection and use of different databases and platforms were analyzed. Currently

the COS method is not yet comprehensive. And regarding the particularity of traditional Chinese medicine（TCM）

there are certain problems to be solved in developing COS for TCM

including the standardization of original outcomes

the overlapping of outcome categories

the implementation difficulty to widely seek the international consensus

and the inadequacy of the reflection of TCM characteristics. It is expected to provide references for various stakeholders in developing COS for clinical trials.

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Related Institution

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Dongzhimen Hospital，Beijing University of Chinese Medicine

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