Affiliation:
1. Vector Psychometric Group Chapel Hill North Carolina USA
2. Patient Centered Outcomes Open Health Group Bethesda Maryland USA
3. Neurology Albert Einstein College of Medicine Bronx New York USA
Abstract
AbstractObjectiveTo describe the impact of migraine on functioning based on comprehensive data collection, analysis, and reporting of patients' experiences.BackgroundQualitative research conducted to understand patients' perspectives on living with migraine has often focused on narrow topics or specific groups of patients or has been selectively reported.MethodsQualitative interviews with 71 participants were conducted during two concept elicitation studies as part of the Migraine Clinical Outcome Assessment System (MiCOAS) project, an FDA grant‐funded program designed to develop a core set of patient‐centered outcome measures for migraine clinical trials. Participants self‐reported being diagnosed with migraine by a healthcare professional and participated in semi‐structured qualitative interviews about their experiences with the symptoms and impacts of migraine. Interview transcripts were coded to identify and define concepts, which were then grouped into broad domains based on conceptual similarities.ResultsA total of 66 concepts were identified: 12 for physical functioning, 16 for cognitive functioning, 10 for social role functioning, 19 for emotional and psychological functioning, and 9 related to migraine management. Participants described a complex and varied relationship between migraine attack symptoms and impacts on functioning. Impacts from migraine were further influenced by numerous contextual factors, such as people's individual social environments and the level of day‐to‐day demand for functioning they face.ConclusionFindings showed that migraine impacted individual functioning in multiple ways and the nature of these impacts was dependent on social‐contextual factors. The results are being used in the development of core measures designed to improve our understanding of the burden of migraine and the efficacy of migraine therapies. The results also offer new insights and raise new questions about migraine experience that can be used to guide future research.
Funder
U.S. Food and Drug Administration
Subject
Neurology (clinical),Neurology