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. 2021 Nov 30;11(11):e043242.
doi: 10.1136/bmjopen-2020-043242.

Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

Kirstie Haywood  1 , Rachel Potter  2 , Robert Froud  3 , Gemma Pearce  4 , Barbara Box  5 , Lynne Muldoon  5 , Richard Lipton  6 , Stavros Petrou  7 , Regina Rendas-Baum  8 , Anne-Marie Logan  9 , Kimberley Stewart  5 , Martin Underwood  5 , Manjit Matharu  10 ; CHESS COSMIG group
Collaborators, Affiliations

Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative

Kirstie Haywood et al. BMJ Open. .

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.

Keywords: clinical trials; migraine; statistics & research methods.

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Conflict of interest statement

Competing interests: MU and RF are directors and shareholders of Clinvivo and are part of an academic partnership with Serco related to return to work initiatives. MU recused himself from any discussions related to the choice of Delphi platform for this study; is a chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research and Arthritis Research UK, and is a co-investigator on grants funded by the Australian NHMRC; is a National Institute for Health Research (NIHR) senior investigator; has received travel expenses for speaking at conferences from the professional organisations hosting the conferences; is a co-investigator on two NIHR-funded studies receiving additional support from Stryker; has accepted honoraria for teaching/lecturing from CARTA; and was an editor of the NIHR journal series and a member of the NIHR Journal Editors Group, for which he received a fee. MM serves on the advisory board for Abbott, Allergan, Eli Lilly, Medtronic, Novartis and TEVA; has received payment for the development of educational presentations from Allergan, electroCore, Eli Lilly, Medtronic, Novartis and TEVA; and has received research grants from Abbott, electroCore and Medtronic. SP is a director of Health Psychology Services, which, in part, provides psychological treatments for those with chronic pain.

Figures

Figure 1
Figure 1
Flow diagram outlining the development stages for the COSMIG. COSMIG, core outcome set with episodic or chronic MIGraine; CM, chronic migraine; EM, episodic migraine.
Figure 2
Figure 2
COSMIG: core outcome set for episodic and chronic migraine.
See this image and copyright information in PMC

References

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