Trial reportHeadache2021
Psychometric validation and meaningful within-patient change of the Migraine-Specific Quality of Life questionnaire version 2.1 electronic patient-reported outcome in patients with episodic and chronic migraine.
Trial report in Headache, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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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.
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.
Who cites it
15 citing papers in PubMed.
- Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine.Journal of patient-reported outcomes · 2023Trial
- Changes in Migraine-Related Outcomes and Functioning at 1 Year: Results of the Longitudinal OVERCOME (US) Study.Neurology and therapy · 2026Article
- Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study.Noro psikiyatri arsivi · 2026Article
- Observational
- Magnesium supplementation for migraine prophylaxis.The Cochrane database of systematic reviews · 2025Article
- Fear of Movement: Validity and Reliability Study of the Turkish Version of the Tampa Scale of Kinesiophobia for Headache in Patients with Migraine.BMC neurology · 2025Article
- Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR).Journal of patient-reported outcomes · 2024Article
- Factors Associated with Patient Adherence to Biofeedback Therapy Referral for Migraine: An Observational Study.Applied psychophysiology and biofeedback · 2024Observational
- Abnormal functional hubs in migraine patients: a resting-state MRI analysis about voxel-wise degree centrality.Journal of oral & facial pain and headache · 2024Article
- Episodic Migraine and Psychiatric Comorbidity: A Narrative Review of the Literature.Current pain and headache reports · 2023Review
- Burden of migraine in patients attending Belgian headache specialists: real-world evidence from the BECOME study.Acta neurologica Belgica · 2023Article
- Review
- Intensive Mindfulness Meditation Reduces Frequency and Burden of Migraine: An Unblinded Single-Arm Trial.Mindfulness · 2023Article
- In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study.The journal of headache and pain · 2021Article
- Minimal Clinically Important Difference (MCID) in Patient-Reported Outcome Measures for Neurological Conditions: Review of Concept and Methods.Annals of Indian Academy of NeurologyArticle
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
objectiveTo evaluate the measurement properties of all three domains of the Migraine-Specific Quality of Life questionnaire version 2.1 (MSQ v2.1) electronic patient-reported outcome (ePRO) to assess the functional impact of migraine in patients with episodic or chronic migraine (CM); and identify meaningful within-patient change thresholds for the Role Function-Restrictive (RFR), Role Function-Preventive (RFP), and Emotional Function (EF) domains.
methodsData were drawn from three double-blind, placebo-controlled, and randomized Phase 3 clinical studies (episodic migraine [EM]: EVOLVE-1 and EVOLVE-2; CM: REGAIN). The psychometric properties of the MSQ v2.1 ePRO domains were demonstrated by evaluating reliability (internal consistency and test-retest), construct validity (convergent and known groups), and responsiveness. Meaningful within-patient change thresholds for domains were estimated using anchor-based approaches, supplemented by empirical cumulative distribution function curves and probability density function plots to enable interpretation of meaningful change over 3 months. The Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement served as anchors.
resultsA total of 2,850 patients with either EM (EVOLVE-1: 851; EVOLVE-2: 909) or CM (REGAIN: 1,090) were included. The Cronbach's alpha estimates of internal consistency exceeded the recommended threshold of ≥0.70 for all domains from the three studies, indicating adequate internal consistency. Test-retest reliability intraclass correlation coefficients were ≥0.80 for all domains across all three studies, demonstrating almost perfect agreement. Convergent validity was supported by moderate-to-strong correlation (r ≥ 0.30) between all domains of MSQ v2.1 ePRO and studied anchors (Migraine Disability Assessment Score and PGI-S scores) across all three studies. Known group validity was established between all domains and subgroups of patients stratified by baseline PGI-S scores and baseline number of monthly migraine headache days for all three studies. The 3-month meaningful within-patient change thresholds were the same for EM and CM for RFP: 20.00 and EF: 26.67; and for RFR: 25.71.
conclusionsThese findings demonstrate that all three domains of the MSQ v2.1 ePRO have sufficient reliability, validity, responsiveness, and appropriate interpretation standards. Our results suggest that MSQ v2.1 ePRO is a well-defined and reliable patient-reported outcome instrument that is suitable for use in clinical studies for evaluating the impact of migraine on patient functioning in episodic and CM.
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