Developing a Core Outcome Set for Traditional Chinese Medicine on Treatment of Ischemic Stroke

Objective: To establish the core outcome index set of clinical trials of Traditional Chinese medicine for the treatment of ischemic stroke, and to provide a reference for the clinical study of traditional Chinese medicine in ischemic stroke.

Methods: Systematically retrieved the Chinese Biomedical Literature Service System (CBM), CNKI Full-Text Database (CNKI), Wanfang Database (WF), Wipro Chinese Full-text Database (VIP), PubMed, The Cochrane Library, Embase and Clinical Research Registration Platform, collected the outcome indicators contained in randomized controlled trials, systematic reviews and registration protocols for the treatment of ischemic stroke in Traditional Chinese medicine, and constructed a pool of outcome index entries. The pool of entries was supplemented by patient surveys, and outcome measures were screened and agreed upon using Delphi expert consultations and consensus meetings.

Results: A total of 9805 literature and 1139 study protocols were collected, and 719 published literature and 196 study protocols were finally included, 452 stroke patients participated in the survey, and the results of the index collection were collated, and a total of 72 outcome indicators were included in the Delphi expert consultation; Two rounds of surveys initially included 24 outcome measures; Through the consensus meeting, 12 outcome indicators in 6 indicator domains were finalized, including clinical endpoint indicators (all-cause mortality, case fatality rate, recurrence rate, incidence of cardiovascular and cerebrovascular events), evaluation of impaired physical function (disability level, neurological deficit, motor dysfunction, cognitive impairment), evaluation of anatomical impairment (cerebrovascular disease, carotid and vertebral artery lesions), limited activity and participation evaluation (including ability to perform activities of daily living), safety (adverse events), and evaluation of TCM syndrome.

Conclusion: According to the manual of the Core Outcome Index Plan Working Group (COMET) of the effectiveness trial, the core outcome index set of the clinical study of ischemic stroke in the treatment of ischemic stroke in traditional Chinese medicine was initially established, which is convenient for relevant investigators to select appropriate and standardized outcome indicators, which is conducive to the promotion of the research conclusions and the comparison and merger of similar studies, thereby improving the evidence quality of the research results.


xie qianwen, xiao jingmin, deng xueyi, chen xueyin, kang fuqin, lai jiaqi, yang lihong, liu shaonan, feng mei, cai yefeng, sun jingbo, guo xinfeng


Journal: Journal of Traditional Chinese Medicine
Volume: 63
Issue: 03
Pages: -
Year: 2022
DOI: 10.13288/j.11-2166/r.2022.03.005

Further Study Information

Current Stage: Completed
Date: January 2019 - 2020
Funding source(s): SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Health Area

Disease Category: Neurology

Disease Name: Ischemic stroke, Acute ischemic stroke, 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
- Methodologists
- 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

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

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