中国临床试验核心指标集研究数据库平台构建  

Construction of A Research Database Platform for the Core Outcome Set of Clinical Trials in China

作　　者：张明妍 牛柏寒[1,2] 牛复生 蔡慧姿 吴莉 李凯[1,2] 生晓迪 郑文科 温川飙 张俊华[1,2] Zhang Mingyan;Niu Bohan;Niu Fusheng;Chua Huizi;Wu Li;Li Kai;Sheng Xiaodi;Zheng Wenke;Wen Chuanbiao;Zhang Junhua(Evidence-Based Medicine Centre,Tianjin University of Traditional Chinese Medicine,Tianjin 301617 China;Institute of Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Institute of Digital Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]天津中医药大学循证医学中心,天津301617 [2]天津中医药大学中医药研究院,天津301617 [3]成都中医药大学数字医药研究所,成都611137

出　　处：《世界科学技术-中医药现代化》2021年第8期2550-2555,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：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;国家自然科学基金委员会资助项目(81904056):中医药临床试验核心指标(COS)测评方法学研究,负责人:张明妍

摘　　要：核心指标集(Core Outcome Set,COS)的研制是解决当前临床试验结局指标异质性大、发表偏倚、不重要、不公认等共性问题的关键途径。为推动核心指标集研究发展,中国临床试验核心指标集研究中心(Chinese Clinical Trial Core Outcome Set,ChiCOS)建立了专业化数据库平台。本文从ChiCOS数据库平台的架构设计、平台功能与有效性试验核心结局指标(Core Outcome Measures in Effectiveness Trials,COMET)数据平台特点比较等方面,对ChiCOS数据库平台进行介绍,以期更好地为核心指标集研究提供技术支持。The development of the core outcome set(COS)is a key way to solve the common problems of current clinical trial outcomes,such as large heterogeneity,publication bias,unimportance,and unrecognition.At present,the importance of COS research has received increasing attention,and the number of researches is gradually increasing.In order to promote the development of COS research,the Chinese clinical trial core outcome set(ChiCOS)has established a specialized database platform.The platform can collect and disseminate the latest results of COS research and organize training,facilitate COS research retrieval and information release,and serve COS research practice in China,especially in the field of Chinese medicine.At present,the design and construction of the database has been completed,and equipped with the COS Delphi automatic survey and data analysis system,which has been fully online and put into use in November 2020,becoming a technical support system for China′s effectiveness,safety and secondary research on COS related research.This paper introduced the ChiCOS database platform from the aspects of its design architecture,platform functions,and characteristics comparison with the COMET data platform,in order to better provide technical support for the research on the core outcome set.

关 键 词：核心指标集 数据库 结局指标 临床试验 中医药 

分 类 号：TP311.13[自动化与计算机技术—计算机软件与理论] R-05[自动化与计算机技术—计算机科学与技术]