Stroke associates with significant morbidity, mortality and healthcare expenditure. Demands for rehabilitation have increased. Chinese medicine (CM) is used for treatment of dysfunction of stroke for a long history. Some researchers reported CM has the potential effect for rehabilitation on motor aphasia, limb spasticity, dysphagia, mild cognitive disorder and depression, such as acupuncture, moxibustion, massage and herbal medicine, etc. Recent years, numbers of clinical trials of CM are being conducted in stroke rehabilitation area. However, the heterogeneity of outcomes and outcome measurement instruments result in many trials limited the quality of the trials. High quality of evidences for CM in stroke rehabilitation is insufficient. Meanwhile, some specific CM-related outcomes for stroke rehabilitation are not concentrating enough on patient important outcome in the clinical practice of CM, which make the outcome measurement of CM became difficulty. The core outcome and outcome measurement instruments set of CM for stroke rehabilitation in motor aphasia, limb spasticity, dysphagia, mild cognitive disorder, depression has not been developed. Therefore, it is important to develop a core outcome set for the five types of dysfunction in stroke rehabilitation in clinical trials of CM.
ContributorsJianxiong Cai, xiaojia Ni and Darong Wu are the principal investigators,
Taoying Lu, Lingjia Yin, Huiyan Zhang, Jingwen Yan
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
The 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
Disease Category: Neurology, Rehabilitation
Disease Name: Stroke
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Other, Traditional Chinese Medicine
- Clinical experts
- Consumers (patients)
- Ethicists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Literature review
There will be six key stages to development of the COS: (1) Systematic review and patients interviews to identify currently reported outcomes in clinical trials of CM in five types of dysfunction in stroke rehabilitation. (2) Development of a panel of experts (3) Two-round Delphi survey to gain expert opinions (4) Consensus meeting to finalize the items and definitions (5)Development of the measurement instrument set base on the core outcome. (6)Promotion and update.