COMET Initiative | Developing a Core outcome set of Traditional Chinese Medicine on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Developing a Core outcome set of Traditional Chinese Medicine on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME) is a syndrome characterized by prolonged non-reducible fatigue. In recent years, the incidence of CFS has increased due to greater social pressure. It causes poor health-related quality of life, and a heavy economic burden on the family and society. There are a large number of clinical studies affirming Traditional Chinese medicine(TCM) may provide symptomatic relief. However, the heterogeneous reporting of outcomes in these clinical trials can’t provide high-level evidence for systematic evaluation or meta-analysis. Therefore, it is necessary and urgent to developing a Core outcome set(COS) of TCM (acupuncture and moxibustion) on CFS/ME.

Aim

To develop a Core outcome set for Traditional Chinese Medicine (acupuncture and moxibustion) for the treatment of people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Contributors

Lin Hui,Yi Tang,Quanying Yin,Haodong Yang,Qihui Lin,Sanmei Xu,Ying Yang,Yating Jiang,Yi An,Ziyu Guo,Xi Wu from Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China

Further Study Information

Current Stage: Ongoing
Date: December 2022 - 2025
Funding source(s): General Program of the National Natural Science Foundation of China(82274667), Xinglin Scholar Research Premotion Project of Chengdu University of TCM (XKTD2021004)

Health Area

Disease Category: Other

Disease Name: Chronic Fatigue Syndrome

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Journal editors
- Methodologists
- Statisticians

Study Type

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

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

First, we will systematically evaluate the outcome indicators of Standards, guidelines of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis(CFS/ME) to Conduct a systematic review. The survey to doctors, and qualitative semi-structured interviews to caregivers or patients also should be considered. All this may produce the core outcome candidate item list.
Second, we will identify the stakeholder groups participating in the Delphi process and Consensus conference, including:Clinical experts, Consumers(patients), Journal editors, Methodologists, Epidemiologists, Statisticians, Clinical guideline developers.Then,we will conduct two or three rounds of Delphi process.
At last, COS-STAR and Explanation and Elaboration document is developed, and will regularly modified.

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