Content validity of the Migraine-Specific Quality of Life Questionnaire version 2.1 electronic patient-reported outcome

PURPOSE: A concept elicitation, cognitive debriefing, and usability study was undertaken to: 1) ascertain the migraine experience with a particular focus on the impact on roles and daily functioning; 2) determine the comprehensiveness and comprehensibility of the Migraine-Specific Quality of Life Questionnaire version 2.1 electronic patient-reported outcome Role Function-Restrictive (MSQ v2.1 ePRO RFR) domain items, and the appropriateness and understanding of the recall period, response options, and instructions; and 3) assess the usability on an electronic tablet device. METHODS: Eleven US English-speaking people with episodic or chronic migraine were recruited to participate in one-on-one interviews, encompassing methods appropriate for concept elicitation, cognitive debriefing, and usability testing. Interviews were audio-recorded, transcribed, and analyzed following the constant comparative method. RESULTS: Participants (seven episodic and four chronic) had a mean age of 34.8 years, and nine were female. Through spontaneous mention or probing, the concepts of the MSQ v2.1 ePRO RFR domain items were described and endorsed by all participants as day-to-day functioning restrictions; except for item 5 (ability to concentrate), which was endorsed by 10 of 11 participants. Cognitive interviewing confirmed the MSQ v2.1 ePRO instructions were clear, meaningful, and important to assess as daily functioning impacts experienced as a result of migraine. Overall impressions of the ePRO device were favorable, and no participants reported any difficulties with use. CONCLUSIONS: The MSQ v2.1 ePRO RFR domain is content-valid and appropriate for inclusion in future studies designed to measure the functional impact of episodic or chronic migraine on the performance of day-to-day activities.