Development and validation of MIGRAGILE: a brief digital patient-reported outcome measure to identify disabling migraine in primary care and support referral to specialised care
Abstract
Abstract Background Migraine is a highly prevalent neurological disorder and a leading cause of disability worldwide. Despite the availability of effective preventive therapies, many individuals with disabling migraine remain underdiagnosed or undertreated, particularly in primary care. Patient-reported outcome measures (PROMs) can help capture disease burden directly from patients and support early clinical stratification. We aimed to develop and validate MIGRAGILE, a brief 11-item digital self-administered PROM designed to identify, in primary care, patients who are likely to have disabling migraine and to support structured referral decisions to specialised care. Methods We conducted a multicentre study across 20 primary care centres and one tertiary hospital in Spain. MIGRAGILE was developed through systematic literature review, multidisciplinary expert consensus, and direct patient input during development and face-validity assessment, followed by pilot testing and psychometric validation. Content validity was assessed using the Hambleton-Rovinelli item-domain congruence procedure, and face validity by patients and clinicians. Test-retest reliability (7–14 days) and inter-observer agreement (three neurologists, two advanced practice nurses, one clinical researcher) were evaluated using weighted Cohen's kappa, Fleiss' kappa, and intraclass correlation coefficients (ICC). Criterion validity/classification performance was assessed against a headache-specialist ICHD-3…
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