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

<br><strong>Objective </strong>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...

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Autori principali: Haywood, K, Potter, R, Froud, R, Pearce, G, Box, B, Muldoon, L, Lipton, R, Petrou, S, Rendas-Baum, R, Logan, A-M, Stewart, K, Underwood, M, Matharu, M
Natura: Journal article
Lingua:English
Pubblicazione: BMJ Publishing Group 2021
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author Haywood, K
Potter, R
Froud, R
Pearce, G
Box, B
Muldoon, L
Lipton, R
Petrou, S
Rendas-Baum, R
Logan, A-M
Stewart, K
Underwood, M
Matharu, M
author_facet Haywood, K
Potter, R
Froud, R
Pearce, G
Box, B
Muldoon, L
Lipton, R
Petrou, S
Rendas-Baum, R
Logan, A-M
Stewart, K
Underwood, M
Matharu, M
author_sort Haywood, K
collection OXFORD
description <br><strong>Objective </strong>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). <br><strong> Design </strong>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. <br><strong> Results </strong>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. <br><strong> Conclusion</strong> 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.
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spelling oxford-uuid:3e8a2228-af2d-44fc-a0dd-a2199ebb5a1d2022-03-26T14:26:06ZCore outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiativeJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:3e8a2228-af2d-44fc-a0dd-a2199ebb5a1dEnglishSymplectic ElementsBMJ Publishing Group2021Haywood, KPotter, RFroud, RPearce, GBox, BMuldoon, LLipton, RPetrou, SRendas-Baum, RLogan, A-MStewart, KUnderwood, MMatharu, M<br><strong>Objective </strong>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). <br><strong> Design </strong>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. <br><strong> Results </strong>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. <br><strong> Conclusion</strong> 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.
spellingShingle Haywood, K
Potter, R
Froud, R
Pearce, G
Box, B
Muldoon, L
Lipton, R
Petrou, S
Rendas-Baum, R
Logan, A-M
Stewart, K
Underwood, M
Matharu, M
Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title_full Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title_fullStr Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title_full_unstemmed Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title_short Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international, consensus-derived and multistakeholder initiative
title_sort core outcome set for preventive intervention trials in chronic and episodic migraine cosmig an international consensus derived and multistakeholder initiative
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