Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine

作     者：Rui-jin Qiu Min Li Jia-yuan Hu Jing Chen Hong-cai Shang Rui-jin Qiu;Min Li;Jia-yuan Hu;Jing Chen;Hong-cai Shang

作者机构：Key Laboratory of Chinese Internal Medicine of Ministry of Education and BeijingDongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China The Third Affiliated HospitalBeijing University of Chinese MedicineBeijing 100029China Dermatology DepartmentBeijing Hospital of Traditional Chinese MedicineBeijing 100010China Department of Health CareBaokang HospitalTianjin University of Traditional Chinese MedicineTianjin 300193China 

出 版 物：《Journal of Integrative Medicine》 (结合医学学报（英文版）)

年 卷 期：2021年第19卷第5期

页      面：389-394页

核心收录：

学科分类：1006[医学-中西医结合] 100601[医学-中西医结合基础] 10[医学] 

基　　金：supported by the National Natural Science Foundation of China (No. 81904051) Young Elite Scientists Sponsorship Program by China Association of Chinese Medicine (No.CACM-2019-QNRC2-A03) the Basic Research Foundation of Beijing University of Chinese Medicine (No. 2019-JYB-JS-033) 

主　　题：Clinical trials Outcome assessment Traditional Chinese medicine Integrative medicine Methodology 

摘      要：Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine(TCM)and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic *** excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets(COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps:(i) development of a comprehensive list of outcomes(including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records;(ii) merging and grouping of outcomes within domains;(iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome-set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.