Evidence map›Paper›PMID 30861580›Full record

Trial reportHeadache2019

Psychometric Validation of the Role Function Restrictive Domain of the Migraine Specific Quality-of-Life Questionnaire Version 2.1 Electronic Patient-Reported Outcome in Patients With Episodic and Chronic Migraine.

Rebecca M Speck, Huda Shalhoub, Kathleen W Wyrwich, Ren Yu, David W Ayer, Janet Ford, Elizabeth N Bush, Richard B Lipton

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Headache, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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

16 citing papers in PubMed.

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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

8 authors.

Rebecca M SpeckEvidera, Bethesda, MD, USA.ORCID 0000-0002-3580-117X
Huda ShalhoubEvidera, Bethesda, MD, USA.
Kathleen W WyrwichEli Lilly and Company, Indianapolis, IN, USA.
Ren YuEvidera, Bethesda, MD, USA.
David W AyerEli Lilly and Company, Indianapolis, IN, USA.
Janet FordEli Lilly and Company, Indianapolis, IN, USA.
Elizabeth N BushEli Lilly and Company, Indianapolis, IN, USA.
Richard B LiptonAlbert Einstein College of Medicine, Bronx, NY, USA.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

objectivesTo assess the measurement properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain to evaluate the functional impact of migraine in patients with episodic (EM) or chronic migraine (CM) enrolled in clinical trials.

methodsThe 7-item MSQv2.1 ePRO RFR measures the functional impact of migraine on relationships with family and friends, leisure time, work or daily activities, productivity, concentration, tiredness, and energy. Measurement properties of the RFR were assessed using data from 2 EM (CGAG [n = 851] and CGAH [n = 909]) and 1 CM (CGAI [n = 1090]) Phase 3 galcanezumab clinical trials. Anchor- and distribution-based analyses were utilized to derive a responder threshold for clinical interpretation of change over time. The Migraine Disability Assessment (MIDAS), Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), and migraine headache days (MHD) served as anchors. Responsiveness and responder threshold analyses were completed from baseline to the average of months 4-6 for EM studies, and from baseline to month 3 for the CM study; timeframes selected were based on the primary endpoints in these studies.

resultsCronbach's alpha values for internal consistency reliability were 0.93, 0.92, and 0.92, for CGAG, CGAH, and CGAI, respectively. Test-retest reliability intra-class correlation coefficients were 0.82 and 0.84 for CGAG and CGAH, and 0.85 for CGAI in stable patients. Convergent validity was supported by moderate to strong correlations (≥0.30) between the RFR and both MIDAS and PGI-S. Known-groups validity was established between subgroups stratified by baseline PGI-S and MHD (P < .05; δ = 0.35-1.96). For the EM studies, anchor variables suggested a change of ≥25 points (equivalent to 9 points/state changes on raw scale) in the RFR was an appropriate threshold to interpret a treatment benefit. For the CM study a change of ≥17.14 points (6 points/state changes on raw scale) was an appropriate threshold. In all 3 studies, significantly (P < .01) more galcanezumab patients achieved the responder definition thresholds, as compared to placebo (odds ratios of 1.98, 2.45, 2.27, 2.44, 1.64, and 1.66 for the 120 and 240 mg arms in the CGAG, CGAH, and CGAI trials, respectively).

conclusionThe MSQv2.1 ePRO RFR has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in EM and CM clinical trials to assess the functional impact of migraine.

Indexed as

Patient Reported Outcome MeasuresAdolescentAdultAgedChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersPsychometricsQuality of LifeRecovery of FunctionReproducibility of ResultsSurveys and Questionnaireschronic migraineepisodic migraineMigraine-Specific Quality of Life Questionnairepsychometric validation

Identifiers

PMID30861580
PMCPMC6593730

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.