A core outcome set for clinical trials of Traditional Chinese Medicine for Sjogren's syndrome

Objective: To develop a core outcome set (COS) for Sjogren's Syndrome treatment by traditional chinese medicine, which should assist in standardizing outcome selection, collection and reporting in future research studies.
Methods: Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design: (1) Focus groups and interviews with key stakeholder groups (patient living with Sjogren's Syndrome, researchers and clinician) and a review of the literature will be undertaken to build a long list of outcomes; (2) Three rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with patient living with Sjogren's Syndrome and clinician; (3) A consensus meeting will be convened with key participant groups to discuss the key findings and finalize the COS.
Discussion: We hope that the COSs will lead to an improvement in the quality of evidence-based
clinical practice, enhance patient care, and improve the quality and consistency of research.

Contributors

Ming Liu, Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University;
Ya Gao,Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University;
Yuan Yuan,Gansu University of Chinese Medicine;
Junhua Zhang,Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine;
Jinhui Tian,Evidence Based Medicine Center, School of Basic Medical Sciences, Lanzhou University.

Further Study Information

Current Stage: Ongoing
Date: December 2019 - January 2021
Funding source(s): None


Health Area

Disease Category: Rheumatology

Disease Name: Sjogren's syndrome

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Families
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Semi structured discussion
- Systematic review

(1) Bulid the COS pool:a systematic review of the literature, sjogren's syndrome patients who have received TCM treatment and an online healthcare professional (HCP) item generation survey;(2) 3 anonymous online Delphi rounds; (3) face-to-face consensus meetings.

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