Interictal burden in migraine: a systematic review of conceptual domains and measurement properties of instruments
摘要
Migraine imposes significant burden not only during acute attacks but also during headache-free interictal periods. Several patient-reported outcome measures (PROMs) have been used to assess this interictal burden, yet the quality of their measurement properties has not been systematically evaluated.
ObjectivesTo identify instruments used to assess interictal burden in migraine, evaluate their measurement properties using the COSMIN methodology, and synthesize the conceptual domains of interictal burden.
MethodsA systematic search of MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science Core Collection was conducted from database inception to 20 February 2026. Studies evaluating measurement properties of PROMs assessing interictal burden or migraine impact in migraine populations were eligible. The COSMIN risk-of-bias checklist and criteria for good measurement properties were applied. Findings were synthesized in accordance with PRISMA 2020.
ResultsAmong 29 included studies, three instruments were identified: the Migraine Interictal Burden Scale-4 (MIBS-4; 26 studies), the Eurolight questionnaire (1 study), and the Fear of Attacks Inventory (FAMI; 2 studies). Seven conceptual domains of interictal burden were identified: functional impairment, social and relational impact, psychological and emotional distress, cognitive dysfunction, sensory symptoms, physical symptoms, and behavioral modifications. Evidence of measurement properties was concentrated in construct validity (19 studies) and responsiveness (8 studies). Structural validity, internal consistency, test–retest reliability and content validity were sparsely evaluated. The MIBS-4 demonstrated consistent convergent and known-groups validity and sensitivity to change across preventive therapies, including CGRP-targeted treatments and onabotulinumtoxinA.
ConclusionsThe MIBS-4 is the most widely used instrument for assessing interictal burden. Despite encouraging evidence of construct validity and responsiveness, comprehensive psychometric studies addressing content and structural validity, reliability, and measurement error, alongside conceptual work towards broader interictal burden assessment, are needed.
RegistrationPROSPERO CRD420261296323; Clinical trial number: not applicable.