Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 21, 2024
Date Accepted: Dec 11, 2024
Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Delphi Consensus Study Protocol
ABSTRACT
Background:
Tension-type headache (TTH) is the most common type of headache and the second most common health-related complaint among children and adults. Traditional Chinese medicine (TCM) has a unique therapeutic effect in treating TTH. However, the standardization of clinical trials limits the development of evidence to support the use of TCM in treating TTH. The limitations include a lack of accepted outcomes that are applicable for assessments, a lack of consensus about the various outcomes and indices, high risks of selective reported bias, and missing data. Thus, establishing a core outcome set (COS) for TCM clinical trials for TTH is necessary. This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM.
Objective:
This study aims to develop a COS for future clinical studies on the treatment of TTH with TCM.
Methods:
This COS will be developed in the following three stages: (1) Systematic reviews and semi-structured interviews will be used to determine potential essential outcomes. The steering committee will evaluate these outcomes to finalize a preliminary list of outcomes. (2) A two-round Delphi survey with stakeholders (healthcare experts and patients with TTH) will be conducted to establish the significance of the results. (3) A face-to-face consensus conference will be held to develop the final COS and recommend measurement times for each outcome.
Results:
The protocol has been registered in PROSPERO, with the review commencing on October 1, 2024, and anticipated results by November 15, 2024. The systematic reviews will be finalized, followed by the Delphi survey and consensus conference in late 2024 and early 2025. The Core Outcome Set (COS) findings will be reported per COS-STAR guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application.
Conclusions:
This study is necessary as developing a COS for future TCM clinical studies in the treatment of TTH can maximize the value of data from individual trials and provide high-quality research evidence. Clinical Trial: This study has been registered with the Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/1473).
Citation
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Copyright
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