Core Outcome Measures in Effectiveness Trials

Developing a COSMA (Core Outcome Set for Migraine through the Acupuncture) in Patients based on the Delphi Survey and Analytic Hierarchy Process (AHP)

General Information

Summary:
Migraine is one of the most common chronic neurovascular disease. The World Health Organization (WHO) had identified the severe migraine as one of the most crippling chronic diseases, which similar to paralysis, dementia and severe mental disease. As an ancient medical therapy, acupuncture has increasingly attracted the public interest on its unique advantages in treating migraine. However, there is insufficient evidences with high quality for clinical study in China, especially lack of the objective evaluation indexes and standardized outcome indicators. It is necessary to develop the Core Outcome Set for Migraine with the Acupuncture (COSMA) in clinical trials, improving the consistency of clinical outcome reporting and objective evaluation of effectiveness.

Contributors:
Dr. Zhaofeng Shi, Dr.Xinyi Li, Dr.Yeyin Hu, Dr.Xiatian Zhang, and Pro.Guihua Tian

Further Study Information

Current Stage:
Ongoing
Date:
August 2018 - August 2019
Funding source(s):
No funding sources

Health Area

Disease Category
Neurology

Disease Name
Migraine

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Complementary and alternative medicine (CAM) therapy

Method(s)

Consensus conference
Consensus meeting
Delphi process
Semi structured discussion
Systematic review

Firstly, the systematic review was conducted by searching and reviewing all potentially outcomes for the acupuncture therapy on migraine in the mainstream clinical databases. Simultaneously, the semi-structured interviews were established to gain the aspect of what the most patients care about. Secondly, all preliminary items in the COSMA was confirmed by Steering Committee through the way of the expression standardization, the similar items combination and the original list categorization. Then, the score method of The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was followed to design the option of the questionnaire and the group of the important grading items of the COSMA about experts and patients was acquired by the two-round Delphi survey. The Analytic Hierarchy Process (AHP) was performed to weigh and assess the comprehension of experts and patients about the importance of COSMA. Finally, the expert panel meeting will be conducted with 20 experts invited. All members will vote and decide the final recommended COSMA from potential core outcomes.
The semi-structured interview will be performed again and a clinical trial will be made to validate the COSMA.


Stakeholders Involved

Clinical experts
Conference participants
Epidemiologists
Methodologists
Patient/ support group representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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