Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study
BackgroundTension-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) offers unique therapeutic benefits in treating TTH. However, the lack of standardized ev...
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JMIR Publications
2025-02-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2025/1/e63481 |
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| author | Guojing Fu Yunmeng Chen Xiao Liang Chunli Guo Xueming Fan Xiao Gong Wenjie Chen Jing Teng Jun Tang Xing Liao Jingjing Wei Yunling Zhang |
| author_facet | Guojing Fu Yunmeng Chen Xiao Liang Chunli Guo Xueming Fan Xiao Gong Wenjie Chen Jing Teng Jun Tang Xing Liao Jingjing Wei Yunling Zhang |
| author_sort | Guojing Fu |
| collection | DOAJ |
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BackgroundTension-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) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence—such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data—has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings.
ObjectiveThis study aims to develop a COS for future clinical studies on the treatment of TTH with TCM.
MethodsThe COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings.
ResultsThe 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 COS findings will be reported per COS-STAR (Core Outcome Set–STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application.
ConclusionsThis 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.
Trial RegistrationCore Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p
International Registered Report Identifier (IRRID)PRR1-10.2196/63481 |
| format | Article |
| id | doaj-art-84a954c7128842828f074cb6c5b81801 |
| institution | Kabale University |
| issn | 1929-0748 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | JMIR Publications |
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| series | JMIR Research Protocols |
| spelling | doaj-art-84a954c7128842828f074cb6c5b818012025-02-05T22:00:53ZengJMIR PublicationsJMIR Research Protocols1929-07482025-02-0114e6348110.2196/63481Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus StudyGuojing Fuhttps://orcid.org/0000-0002-6313-2495Yunmeng Chenhttps://orcid.org/0009-0001-6015-6408Xiao Lianghttps://orcid.org/0000-0001-5608-8038Chunli Guohttps://orcid.org/0000-0002-0238-2378Xueming Fanhttps://orcid.org/0000-0002-1126-0698Xiao Gonghttps://orcid.org/0009-0009-5843-4761Wenjie Chenhttps://orcid.org/0009-0006-9587-2566Jing Tenghttps://orcid.org/0000-0001-8514-4406Jun Tanghttps://orcid.org/0009-0001-4878-2246Xing Liaohttps://orcid.org/0000-0002-5745-755XJingjing Weihttps://orcid.org/0000-0003-2020-8397Yunling Zhanghttps://orcid.org/0000-0002-9709-9566 BackgroundTension-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) offers unique therapeutic benefits in treating TTH. However, the lack of standardized evidence—such as inconsistencies in outcome selection and reporting in clinical studies, a lack of consensus on outcomes and measures, high risks of selective reporting bias, and missing data—has limited the development of robust evidence supporting the efficacy of TCM in treating TTH. Therefore, establishing a core outcome set (COS) is crucial for standardizing TCM clinical studies for TTH, thereby enhancing the quality and comparability of research findings. ObjectiveThis study aims to develop a COS for future clinical studies on the treatment of TTH with TCM. MethodsThe COS will be developed through the following 3 stages. First, systematic reviews and semistructured interviews will be conducted to identify potential essential outcomes, which will be evaluated by the steering committee to finalize a preliminary list of outcomes. Data will be processed using thematic analysis to ensure comprehensive coverage of relevant outcomes. Second, a 2-round Delphi survey will be conducted, inviting stakeholders, including health care experts and patients with tension-type headaches, to determine the importance of each outcome. Statistical analysis will be used to assess the level of consensus and prioritize outcomes based on predefined criteria. Third, a face-to-face consensus meeting will be held to finalize the COS and recommend measurement times for each outcome. Key outcomes will be interpreted based on their clinical relevance and feasibility of measurement, ensuring the COS is comprehensive and applicable in clinical settings. ResultsThe 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 COS findings will be reported per COS-STAR (Core Outcome Set–STAndards for Reporting) guidelines, published in an international journal, presented at conferences, and disseminated to participants for clinical application. ConclusionsThis 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. Trial RegistrationCore Outcome Measures in Effectiveness Trials Initiative 1473; https://tinyurl.com/3ts62s2p International Registered Report Identifier (IRRID)PRR1-10.2196/63481https://www.researchprotocols.org/2025/1/e63481 |
| spellingShingle | Guojing Fu Yunmeng Chen Xiao Liang Chunli Guo Xueming Fan Xiao Gong Wenjie Chen Jing Teng Jun Tang Xing Liao Jingjing Wei Yunling Zhang Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study JMIR Research Protocols |
| title | Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study |
| title_full | Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study |
| title_fullStr | Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study |
| title_full_unstemmed | Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study |
| title_short | Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study |
| title_sort | core outcome set development for tension type headache treatment using traditional chinese medicine protocol for a delphi consensus study |
| url | https://www.researchprotocols.org/2025/1/e63481 |
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