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Updated: Oct 11, 2025

3D-Neuronavigation In Vivo Through a Patient's Brain During a Spontaneous Migraine Headache
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Core outcome set for preventive intervention trials in chronic and episodic migraine (COSMIG): an international,

Kirstie Haywood1, Rachel Potter2, Robert Froud3

  • 1Warwick Research in Nursing, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.

BMJ Open
|December 1, 2021
PubMed
Abstract

Insights

A new core outcome set for migraine (COSMIG) was developed to improve research consistency. It focuses on migraine-specific pain and quality of life, offering a more holistic view for migraine prevention trials.

Area of Science:

  • Neurology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • Migraine prevention trials often focus narrowly on reducing migraine days.
  • Inconsistent outcome selection across studies hinders data pooling and evidence synthesis.
  • A standardized approach is needed to capture patient-important outcomes in migraine research.

Purpose of the Study:

  • To develop a core outcome set for migraine (COSMIG) through international, multistakeholder consensus.
  • To establish a standardized set of outcomes for evaluating preventive migraine interventions.
  • To improve the quality and comparability of migraine clinical trial data.

Main Methods:

  • A two-stage approach involving an electronic-Delphi study with expert panellists (patients, healthcare professionals, researchers).
  • A comprehensive list of outcomes was reduced and prioritized through three Delphi rounds.
  • A consensus meeting finalized the core domains and assessment methods, overseen by an international core team.

Main Results:

  • High participation and retention rates from diverse patient and healthcare professional groups.
  • The initial >50 outcomes were reduced to 7 core domains for the consensus meeting.
  • A 2-domain core outcome set was agreed upon for migraine research.

Conclusions:

  • Consensus was reached on a two-domain core outcome set for migraine prevention research.
  • The core outcome set includes migraine-specific pain and migraine-specific quality of life.
  • This standardized set will enhance reporting for both episodic and chronic migraine interventions.
Keywords:
clinical trialsmigrainestatistics & research methods

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