Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of Hypertensive Cerebral Hemorrhage

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 hypertensive cerebral hemorrhage. However, the standardization of clinical trials limits the development of TCM on treatment of hypertensive cerebral hemorrhage, 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 hypertensive cerebral hemorrhage in clinical trials of TCM.

Contributors

Yunling Zhang is the principal investigator.
Xiyuan Hospital of China Academy of Chinese Medical Sciences,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 Medicine(ZZ13-024-3)

Health Area

Disease Category: Neurology

Disease Name: Hypertensive cerebral hemorrhage, 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

Method(s)

- 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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