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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. [ABSTRACT FROM AUTHOR]

Objective To compare the methods and baseline characteristics of the American Migraine Prevalence and Prevention (AMPP) and Chronic Migraine Epidemiology and Outcomes (CaMEO) studies. Background The AMPP and CaMEO studies are the largest longitudinal efforts designed to improve our understanding of episodic and chronic migraine in the United States. The studies have complementary strengths and weaknesses. Methods This analysis compares and contrasts the study methods and participation rates of the AMPP and CaMEO studies. We then compare and contrast baseline results in terms of demographic characteristics, headache features, and disability as measured by the Migraine Disability Assessment Scale (MIDAS) among people with episodic and chronic migraine. Results AMPP and CaMEO sampled from panels constructed to be representative of the US population. The AMPP Study collected data using a mailed questionnaire while CaMEO relied on a web survey methodology. Response rates were higher in AMPP (64.8%) than in CaMEO (16.5%). Both studies assessed headache features using the American Migraine Study/AMPP diagnostic module. Both identified persons with episodic (<15 headache days/month) and chronic migraine (≥15 headache days/month) based on the International Classification of Headache Disorders. AMPP collected data annually over 5 years, while CaMEO collected data quarterly over 15 months. Baseline demographic distribution was generally similar, indicating that each study was broadly representative of the US population. The proportion of persons with migraine who had chronic migraine was similar (AMPP, 6.6%; CaMEO, 8.8%). Respondents had similar median headache frequency (days/month) by sex for chronic migraine (AMPP: men = 21.7, women = 20.0; CaMEO: men = 20.0, women = 20.0) and episodic migraine (AMPP: men = 1.7, women = 2.0; CaMEO: men = 2.0, women = 3.0). Median MIDAS scores were substantially higher in both studies for chronic migraine (severe disability [Grade IV]; AMPP: men = 33.0, women = 45.0; CaMEO: men = 32.0, women = 38.0) than episodic migraine (little/mild disability [Grade I/II]; AMPP: men = 3.0, women = 6.0; CaMEO: men = 4.0, women = 7.0). Rates of moderate/severe disability (Grade III/IV) were substantially higher in both studies for chronic migraine (AMPP: men = 66.9%, women = 78.9%; CaMEO: men = 71.0%, women = 82.6%) than episodic migraine (AMPP: men = 23.0%, women = 31.8%; CaMEO: men = 26.7%, women = 37.9%). More women than men respondents in both studies experienced moderate/severe disability. Conclusions AMPP and CaMEO are longitudinal cohort studies that used different methods, but yielded similar results for demographic features, headache frequency, and headache-related disability. Both studies found more severe headache-related disability in those with chronic versus episodic migraine. [ABSTRACT FROM AUTHOR]