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Quality Evaluation and Reporting Specification for Real-World Studies of Traditional Chinese Medicine

Chinese Journal of Integrative Medicine 2022年第12期28卷 1059-1062页

作者： CHAI Qian-yun FEI Yu-tong GAO Rui XIA Ru-yu LU Fang ZI Ming-jie SUN Ming-yue YANG Zhong-qi CHEN Da-fang LIU Jian-ping behalf of the querst School of Traditional Chinese Medicine Beijing University of Chinese MedicineBeijing 100029China Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing 100029China Institute of Clinical Pharmacology of Xiyuan Hospital China Academy of Chinese Medical SciencesBeijing 100091China The First Affiliate Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405China School of Public Health Peking UniversityBeijing 100871China 不详

In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand ***,there is stll a lack of standards for the evaluation of the quality of *** is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine(TCM).To this end,under the guidance of China Association of Chinese Medicine,the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine(querst)Group,including 24 experts(clinical epidemiologists,clinicians,pharmacologists,ethical reviewerand statisticians),was established to develop the *** specification contains the listing of classification of RWS design and RWE,the general principles and methods of RWE quality evaluation(26 tools or scales),25 types of bias in RWS,the special considerations in evaluating the quality of RWE of TCM,and the 19 reporting standards of *** specification aims to propose the quality evaluation principles and key points of RWE,and provide guidance for the proper use of RWE in the development of TCM new drugs.

关键词： real-world study real-world evidence quality evaluation reporting standard Chinese medicine

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