Evidence map›Paper›PMID 34848505›Full record

ArticleBMJ open2021

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

Kirstie Haywood, Rachel Potter, Robert Froud, Gemma Pearce, Barbara Box, Lynne Muldoon, Richard Lipton, Stavros Petrou, Regina Rendas-Baum, Anne-Marie Logan and 4 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 13 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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  9. Non-pharmacological interventions for prophylaxis of vestibular migraine.The Cochrane database of systematic reviews · 2023
    Pooled it
  10. Pharmacological interventions for prophylaxis of vestibular migraine.The Cochrane database of systematic reviews · 2023
    Pooled it
  11. Pharmacological interventions for acute attacks of vestibular migraine.The Cochrane database of systematic reviews · 2023
    Pooled it
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  14. Trial
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  16. Magnesium supplementation for migraine prophylaxis.The Cochrane database of systematic reviews · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Kirstie HaywoodWarwick Research in Nursing, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.ORCID 0000-0002-5405-187X
Rachel PotterClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK R.Potter@warwick.ac.uk.ORCID 0000-0001-6655-8996
Robert FroudInstitute of Health Sciences, Kristiania University College, Oslo, Norway.
Gemma PearceDepartment of Psychology and Behavioural Sciences, Coventry University, Coventry, UK.
Barbara BoxClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Lynne MuldoonClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Richard LiptonDepartment of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA.
Stavros PetrouNuffield Department of Primary Care Health Sciences, Oxford, UK.
Regina Rendas-BaumQualityMetric Incorporated, Lincoln, Rhode Island, USA.
Anne-Marie LoganNeurology Department, St George's University Hospitals NHS Foundation Trust, London, UK.
Kimberley StewartClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Martin UnderwoodClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.ORCID 0000-0002-0309-1708
Manjit MatharuThe Headache Group, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, London, UK.
CHESS COSMIG group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTypically, 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).

designA 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.

resultsThere 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.

conclusionInternational 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.

Indexed as

Migraine DisordersQuality of LifeDelphi TechniqueHumansOutcome Assessment, Health CareResearch DesignTreatment Outcomeclinical trialsmigrainestatistics & research methods

Identifiers

PMID34848505
PMCPMC8634270

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.