QIU Xingying 1 , TANG Qi 1 , CAO Wencong 1 , LIU Bingqing 1 , WEN Zehuai 2,3,4,5 , LI Geng 2,3,5
  • 1. The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;
  • 2. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, P. R. China;
  • 3. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
  • 4. Science and Technology Innovation Center, Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;
  • 5. Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, P. R. China;
WEN Zehuai, Email: wenzh@gzucm.edu.cn; LI Geng, Email: ligeng@gzucm.edu.cn
Core outcomes set; Traditional Chinese medicine; Quality evaluation
10.7507/1672-2531.202306158
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Objective To evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. Methods Literature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. Results A total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. Conclusion COS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.

Citation： QIU Xingying, TANG Qi, CAO Wencong, LIU Bingqing, WEN Zehuai, LI Geng. Quality evaluation of studies on the core outcome set of Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2024, 24(2): 192-201. doi: 10.7507/1672-2531.202306158 Copy

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