The Migraine Specific Quality-of-Life Questionnaire Version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain has sufficient reliability, validity, responsiveness, and appropriate interpretation standards for use in episodic migraine (EM) and chronic migraine (CM) clinical trials to assess the functional impact of migraine, a new study suggests. The 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 clinical trial. Researchers found:
- Cronbach’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 between the RFR and both the Migraine Disability Assessment (MIDAS) and the Patient Global Impression of Severity (PGI-S).
Speck RM, Shalhoub H, Wyrwich KW, et al. 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. [Published online ahead of print March 12, 2019]. Headache. doi:10.1111/head.13497.