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The 7-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) electronic patient-reported outcome (ePRO) Role Function-Restrictive (RFR) domain was found to represent a reliable and valid tool for assessing the functional impact in participants of clinical trials of episodic and chronic migraine, according to a study published in Headache.
The data from three phase 3 clinical trials investigating the effects of galcanezumab on episodic migraine (CGAG; n=851 and CGAH; n=909) and chronic migraine (CGAI; n=1090) were examined to evaluate RFR Responder thresholds of patient-reported changes over time determined using the Migraine Disability Assessment (MIDAS), the Patient Global Impression of Severity (PGI-S), and the Patient Global Impression of Improvement (PGI-I) questionnaires, as well as the number of migraine headache days (MHDs). Responsiveness and responder threshold analyses were performed from baseline to 3 months in the chronic migraine trials and from baseline to 4 to 6 months in the episodic migraine trials.
Internal consistency reliability as assessed with Cronbach’s alpha values were 0.93 for CGAG, 0.92 for CGAH, and 0.92 for CGAI. Reliability coefficients for CGAG, CGAH, and CGAI were 0.82, 0.84, and 0.85, respectively, in stable patients. Subgroups stratified by baseline PGI-S and MHD scores established known-groups validity (P <.05). A ≥25-and a ≥17.14-point change on the RFR were found to represent adequate thresholds for treatment benefit in the chronic and episodic migraine studies, respectively. Patients treated with galcanezumab vs placebo were more likely to achieve the identified responder thresholds in all 3 studies (P <.01 for all).
Study limitations include analysis of clinical trials with narrow demographic populations, which may limit the generalizability of the findings.
“The instrument is psychometrically robust and appropriate for inclusion in future episodic and chronic migraine studies designed to measure the impacts of migraine on role functioning. PROs can provide unique information on the effects of treatment; therefore, establishing a responder definition threshold for the MSQ v2.1 ePRO RFR domain provides the basis for its use in future clinical trials of episodic and chronic migraine,” concluded the study authors.
Reference
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 March 12, 2019]. Headache. doi:10.1111/head.13497
