Psychometric Evaluation of the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Using Data From Phase 3 Clinical Trials in Patients With Chronic Migraine (CM) and Episodic Migraine (EM)
Jonathan Stokes1, David Dodick2, Richard Lipton3, Diane Whalley4, Yulia Savva5, Heather Gelhorn5, Lauren Nelson4, Stuart Yarr4, Pranav Gandhi1
1AbbVie, 2Mayo Clinic, 3Albert Einstein College of Medicine, 4RTI Health Solutions, 5Evidera
Objective:

To evaluate the psychometric properties and establish meaningful within-patient change (MWPC) thresholds of the Migraine-Specific Quality of Life questionnaire (MSQ) v2.1 Role Function-Restrictive (RFR) domain scores using CM and EM trial data.

Background:

The MSQ v2.1 is a 14-item measure of health-related quality of life evaluating impacts attributed to migraine over the past 4 weeks and comprises three domains: RFR, Role Function-Preventive (RFP), and Emotional Function (EF).

Design/Methods:

In separate phase 3, 12-week, double-blind controlled trials (EM: NCT03777059; CM: NCT03855137), participants were randomized to receive atogepant 10 mg QD, 30 mg QD, 60 mg QD or placebo in EM and atogepant 30 mg twice daily, 60 mg once daily (QD) or placebo in CM.  Psychometric properties of the MSQ v2.1 RFR domain were evaluated including reliability, validity (convergent and known-groups), responsiveness, and MWPC based on pooled data within EM and CM trials. 

Results:

Of the 910 and 778 participants enrolled within EM and CM trials, 862 and 744 were included in the analysis, respectively. For both EM and CM, the RFR domain demonstrated good internal consistency (Cronbach’s alpha = 0.93-0.95) and acceptable test-retest reliability (intraclass correlation coefficient: 0.79-0.80). Moderate/strong correlations with activity limitation (0.41-0.59) and the Headache Impact Test-6 (0.70-0.78) support construct validity. RFR domain scores demonstrated differentiation based on Patient Global Impression of Severity (PGI-S) (P < .0001) and domain change scores differed significantly across levels of change on PGI-S, Patient Global Impression of Change (PGIC), and monthly migraine days. Anchor-based results demonstrated similar MWPC estimates in the range of 25 to 28.6 points were clinically meaningful within EM and CM populations.

Conclusions:

The MSQ v2.1 RFR demonstrated strong psychometric properties and MWPC estimates were established using EM and CM trial data. The MSQ v2.1 RFR domain is suitable for use in clinical trials to evaluate treatment benefit related to improvement in functioning. 

10.1212/WNL.0000000000203543