Developing a Core Outcome Set for Clinical Trials of Traditional Chinese Medicine for Rheumatoid Arthritis

Bingbing Yu¹Mengge Song¹Jingdong Yang²Xiaopo Tang¹Congmin Xia¹Junjie Zhang²Xue qi Zhao¹Quan Jiang^1*MAN HAN¹

• ¹Department of Internal Medicine, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China
• ²University of Shanghai for Science and Technology School of Optical-Electrical and Computer Engineering, Shanghai, China

Objective: We developed a consensus-based core outcome set (COS) for Traditional Chinese Medicine clinical trials in rheumatoid arthritis (COS-TCM-RA) that to addresses heterogeneity in outcome measurement and reporting across studies. Methods: We performed a comprehensive systematic review to establish a repository of clinical outcome set for TCM interventions in RA management.Then, a semi-structured interview was conducted to identify additional important outcomes from the patient's perspective. This was followed by an online three-round Delphi survey conducted with professionals to prioritize and refine clinically relevant outcomes from a previously developed longlist. Core entries were finalized based on three Delphi surveys and one expert consensus meeting. Results: The systematic review screened 2959 records and included 69 eligible studies. From these, a comprehensive list of reported outcomes was extracted and standardized, which after standardization ,yielded a final list of 52 unique outcomes for the preliminary consensus process. After semi-structured interviews,three Delphi survey rounds and one consensus meeting,the most important outcomes were determined for COS of Traditional Chinese Medicine for RA(COS-TCM-RA),including physician assessment of global status,Clinical laboratory tests,radiographic assessment,Signs and symptoms,quality of life and security incident. Conclusion: This study developed the first COS-TCM-RA, comprising 11 indicators across five domains: overall disease evaluation, physical and chemical indicators, quality of life, TCM syndromes, and adverse events. By integrating internationally recognized RA assessment tools with patient-reported outcomes and TCM-specific measures, the COS-TCM-RA provides a standardized, multi-dimensional framework to enhance trial quality, improve comparability, and support the integration and internationalization of TCM in evidence-based medicine.