Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
In recent years, cerebrovascular diseases have been the top leading causes of death in China. There are more than 7 million patients with cerebrovascular diseases in China, of which about 70% are ischemic stroke. In clinical practice, Traditional Chinese medicine (TCM) has a unique effect in the treatment of ischemic stroke. An increasing number of trials had been conducted in this area. However, these clinical trials and systematic reviews have failed to confirm the effectiveness of TCM, because the heterogeneous reporting of outcomes in these trials has hindered synthesizing the results in meta-analyses, which reduce the value of trials. Meanwhile, it may exist risk of selective outcome reporting bias in clinical trials. The core outcome set of TCM for the treatment of ischemic stroke have not been standardized. The development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. So it is necessary to develop a COS for ischemic stroke in clinical trials of TCM.

Contributors:
Xinfeng Guo and Yefeng Cai are the principal investigators.
Qianwen Xie, Lihong Yang, Shaonan Liu
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Further Study Information

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

Health Area

Disease Category
Neurology

Disease Name
Acute ischemic stroke
Ischemic stroke
Stroke

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Traditional Chinese Medicine

Method(s)

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.


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

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