Abstract
OBJECTIVE: A concept elicitation, cognitive debriefing, and usability study was undertaken to: (1) explore migraine symptoms and day-to-day impacts; (2) determine the comprehensiveness and comprehensibility of the previously developed 24-Hour Migraine Quality of Life Questionnaire electronic patient-reported outcome (24-Hr MQoLQ ePRO) items, and the appropriateness and understanding of the recall period, response options, and instructions; and (3) assess the usability on an electronic hand-held device. METHODS: Eleven United States English-speaking people with episodic migraine were recruited to participate in one-on-one interviews, which followed methods appropriate for concept elicitation, cognitive debriefing, and usability testing. Interviews were audio-recorded, transcribed, and analyzed following the constant comparative method. RESULTS: Participants had a mean age of 42 years, and 8 were female. Through spontaneous mention or probing, all concepts of the 24-Hr MQoLQ ePRO were endorsed by a majority of the participants. Cognitive interviewing confirmed the 24-Hr MQoLQ ePRO instructions were clear, meaningful, and important to assess as symptoms and day-to-day impacts experienced as a result of migraine. Overall impressions of the ePRO device were overwhelmingly favorable, and the ePRO device was preferred to paper and pencil by all participants. Participant responses regarding the level of headache pain that would be acceptable in order to continue to go about daily activities ranged from 3 to 6, on a scale of 0 to 10, with 0 being "no headache" and 10 being "the worst headache." CONCLUSIONS: The 24-Hr MQoLQ ePRO is content-valid and appropriate for inclusion in future acute treatment for migraine studies designed to measure the symptoms and health-related quality of life of migraine.