VanderPluym JH, Ramirez-Campos V, Cortez A, Cohen J, Gandhi S, Lewis S, Sweeney C, DeMuro C, Lipton R. Patient-reported outcomes to assess symptoms and effects across all 5 phases of migraine. Poster presented at the 2020 ISPOR Virtual Conference; May 2020.


OBJECTIVES: Migraine attacks are associated with a substantial negative impact on patient’s health-related quality of life and functioning; however, migraine is also associated with a significant burden during the phases between headache attacks, including prodrome, postdrome, and the interictal period. The aim of this review was to find sensitive and reliable patient-reported outcomes (PROs) to fully characterize the effects of migraine throughout all phases.

METHODS: For this literature review, 2 specific searches were conducted. One search covered migraine-specific PROs that assess the symptoms, impacts, and experiences of adult patients with migraine. The other search covered current PROs that address symptoms and effects during the prodrome, postdrome, and interictal periods, with a particular focus on the interictal period. The following information was evaluated and summarized for any identified PROs: the descriptive background and the instrument itself, including assessing any possible measurement gaps.

RESULTS: Overall, 15 manuscripts met all criteria, out of the 123 individual citations identified and reviewed. Evaluation of these 15 manuscripts resulted in identification of 7 unique PROs. Four of these 7 PROs were evaluated and summarized in further detail: the Post-Migraine Questionnaire (PMQ), the Migraine Physical Function Impact Diary (MPFID), the Migraine Functional Impact Questionnaire (MFIQ), and the Migraine Interictal Burden Scale (MIBS). A PRO that evaluated symptoms or impacts across all migraine phases (particularly addressing the interictal phase) was not identified in this literature review.

CONCLUSIONS: The PROs identified in this review address a comprehensive constellation of symptoms and impacts across all phases of migraine; however, no single instrument that met the standards set forth in the FDA PRO guidance evaluated all symptoms and effects across the full continuum of migraine. In order to accurately and completely assess the benefits of migraine treatment, a PRO that assesses patient’s experiences with treatment throughout all migraine phases is needed.

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