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Journal of Integrative Medicine ›› 2021, Vol. 19 ›› Issue (5): 389-394.doi: 10.1016/j.joim.2021.07.001

• Methodology • Previous Articles     Next Articles

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

Rui-jin Qiu a, Min Li b, Jia-yuan Hu c, Jing Chen d, Hong-cai Shang a   

  1. a Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China
    b The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, 100029, China
    c Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Beijing, 100010, China
    d Department of Health Care, Baokang Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, Chin
  • Received:2021-04-22 Accepted:2021-06-23 Online:2021-09-15 Published:2021-07-28
  • Contact: Jing Chen; cjshcsyc@126.com; Hong-cai Shang; shanghongcai@foxmail.com.

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 review. The 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 syndromes set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.

Key words: Clinical trials, Outcome assessment, Traditional Chinese medicine, Integrative medicine

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