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A core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG) : an international, consensus-derived and multi-stakeholder initiative
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Haywood, Kirstie L., Potter, Rachel, Froud, Robert J., Pearce, Gemma, Box, Barbara, Muldoon, Lynne, Lipton, Richard, Petrou, Stavros, Rendas-Baum, R., Logan, A., Stewart, Kimberley, Underwood, Martin and Matharu, Manjit (2021) A core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG) : an international, consensus-derived and multi-stakeholder initiative. BMJ Open, 11 . e043242. doi:10.1136/bmjopen-2020-043242 ISSN 2044-6055.
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Official URL: https://doi.org/10.1136/bmjopen-2020-043242
Abstract
Objective Typically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG).
Design A two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners.
Results There was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed.
Conclusion International and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.
| Item Type: | Journal Article | |||||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | |||||||||
| Library of Congress Subject Headings (LCSH): | Migraine, Migraine -- Prevention, Migraine -- Treatment, Clinical trials | |||||||||
| Journal or Publication Title: | BMJ Open | |||||||||
| Publisher: | BMJ | |||||||||
| ISSN: | 2044-6055 | |||||||||
| Official Date: | 30 November 2021 | |||||||||
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| Volume: | 11 | |||||||||
| Article Number: | e043242 | |||||||||
| DOI: | 10.1136/bmjopen-2020-043242 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 19 July 2021 | |||||||||
| Date of first compliant Open Access: | 20 July 2021 | |||||||||
| RIOXX Funder/Project Grant: |
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