Abstract
BACKGROUND: The patient's perspective is increasingly relevant in health decision making. In daily practice, care of patients with migraine should include evaluation of their satisfaction with acute and preventive treatments, the interference with daily living, as well as with the care received by the healthcare team. The aim was to develop and validate a novel specific self-reported patient-reported-experience measure (PREM) in Spanish (Spain), to ascertain satisfaction with migraine treatment; the MISAT-Q questionnaire. METHODOLOGY: A multicenter, crosssectional, non-interventional study was conducted between June 2023 and March 2024 in headache units in Spain. Patients with migraine currently receiving treatment were included. A 35-items preliminary instrument was developed after literature review and cognitive debriefing with experts and patients. Three samples were used: a) 23 patients to assess feasibility/pertinence of items; b) 158 patients for item reduction; and c) 209 patients for validation of PREM. Measures for concept validity included Patient Global Impression of change (PGI), Headache Impact Scale-6 items (HIT-6), and Health-Related Quality-of-life (EQ-5D-3 L). Feasibility, reliability and validity (content, discriminant, construct, and concurrent) were assessed. RESULTS: Feasibility: face value (good acceptance to answer the questionnaire), administration time (below 10 minutes), floor and ceiling effects (below 40% in any extreme response category), percentage of missing values in each item (below 20%) was found in the validation sample. Factor analysis item reduction resulted in a 22-item questionnaire with 7 dimensions: undesirable side effects, treatment effectiveness in crisis and in prevention, convenience-of-use, impact on daily activities, medical care, and global satisfaction, supported with confirmatory factor analysis: CFI = 0.983; TLI = 0.980; χ(2)/df = 1.808; RMSEA = 0.075. Reliability was high: Cronbach's alpha = 0.90 and intraclass-correlation coefficient = 0.95. Dimensions of questionnaire showed significant and moderate convergent correlations with the overall score (0.58-0.68, p < 0.001). Concurrent validity with HIT-6 showed correlation's coefficients ranging from -0.19 to -0.48 (p < 0.01 in all cases, except medical care) and with EQ-5D-3 L (correlations from 0.17 to 0.39, p < 0.05 in all cases, except medical care). Differences in satisfaction were found according with migraine severity (F = 6.73, p = 0.002), as well as in HIT-6 scores (F = 8.20, p < 0.002). MISAT-Q discriminated overall satisfaction between patients with worse, no change and better change with treatment (F = 15.85; p < 0.001). CONCLUSIONS: The MISAT-Q questionnaire is a well-accepted, reliable and valid measure of migraine treatment satisfaction in Spanish. Responsiveness attribute needs to be explored. This novel PREM may facilitate clinicians when making health decision in the treatment management of patients with migraine.