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 2,959 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.
To establish the core outcome index set of clinical trials of Traditional Chinese medicine for the treatment of rheumatoid arthritis, and to provide a reference for the clinical study of traditional Chinese medicine in rheumatoid arthritis. The COS could improve the reliability and consistency of outcome reporting. We hope that this RA-CM-COS will be popularized for clinical trials of traditional Chinese medicine in the treatment of rheumatoid arthritis in the future and improve research quality.
ContributorsQuan Jiang (Principal Investigator), Man Han (supervisor), Mengge Song (supervisor), Jian Liu, Wei Liu, Huadong Zhang, Qingchun Huang, Dongyi He, Jiangyun Peng, Yongfei Fang, Ying Liu, Zhenbin Li, Qingwen Tao, Zeguang Li, Fuzeng Zheng, Jianyong Zhang, Jianping Yu,Xiaopo Tang, Wei Ji, Yutong Fei, Chunmei Li, Wentao Zhu, Mingfeng Huang
Disease Category: Rheumatology
Disease Name: Rheumatoid arthritis
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Survey
- Systematic review
The development of COS will go through the following four steps: (1) A list of outcomes reported in the registered and published trials of traditional Chinese medicine for rheumatoid arthritis will be extracted by conducting a systematic literature review. (2) An additional result lists will be collected through semistructured interview to patients with rheumatoid arthritis. (3) Two rounds of Delphi surveys will be conducted to prioritize and condense the results. (4) A consensus meeting will be held to assess the significance and appropriateness of these results and a final recommended COS will be developed.