Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of cerebral infarction

Stroke is one of the leading causes of morbidity and mortality in both developed and developing countries, and has been the top leading cause of death in China. Traditional Chinese medicine (TCM) has a unique therapeutic effect in the treatment of cerebral infarction. However, the standardization of clinical trials limits the development of TCM on treatment of cerebral infarction, such as no accepted outcomes or indices applied for assessments, or no consensus among the varied outcomes or indices, or high risks of the selective reported bias or lots of missing data, etc. It is necessary to establish a Core Outcome Set for for cerebral infarction in clinical trials of TCM.


Yunling Zhang is the principal investigator.
Xiyuan Hospital of CACMS, Beijing, China

Further Study Information

Current Stage: Ongoing
Date: December 2019 - December 2021
Funding source(s): The optimal subject setting and design of evidence-based research implementation in the area of brain diseases of Traditional Chinese Medicine(ZZ13-024-3)

Health Area

Disease Category: Neurology

Disease Name: Acute cerebral infarction, Stroke

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

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


- Consensus meeting
- Delphi process
- Interview
- Systematic review

Conduct a systematic review and interview to develop an outcome list. And then we will conduct two or three rounds of Delphi process and a consensus meeting to develop a core outcome set.

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