The Migraine Functional Impact Questionnaire (MFIQ) is a novel patient-reported outcome instrument developed as a quality measure of preventive therapies in adults with migraine, according to a study published in Headache. Interviews with patients confirmed that the instrument comprehensively covered the functional effects of migraine relevant to their experience.
Functioning and well-being have become key metrics in evaluating both disease burden and treatment benefit, but many patient-reported methodologies have not been validated. The investigators of this study sought to develop a method for assessing intervention outcomes for preventing migraine attacks in adults; they further sought to validate the MFIQ as a new instrument of patient-reported outcomes.
Initial instrument development included building a conceptual disease model based on interviews of 32 adult patients conducted to understand their experiences with migraine. This model was then used to identify concepts of interests needed to evaluate preventive treatment outcomes. The interview results were further used to create a framework for collecting and measuring data surrounding the concepts of interests. To support the content validity, existing instruments were reviewed for coverage of framework concepts and evidence of saturation in concept elicitation. To evaluate the concepts in the framework, an instrument was drafted and tested in adults with migraine; feedback from 2 rounds of cognitive interviews informed instrument modifications. In the final stage of development, the instrument was linguistically adapted and further tested to ensure conceptual equivalence in the different language versions.
The initial concept elicitation interviews revealed that migraine affected factors of functioning, including physical functioning, everyday activities, and social and emotional functioning, and led to the development of a framework for evaluating functional outcomes. The study investigators found that existing patient-reported outcome instruments did not appropriately capture the concepts of interests, lacked coverage of some concepts included in the MFIQ framework, or did not provide evidence of content validity. Minor changes to items in the MFIQ were made after cognitive interviews with 9 adults with migraine and were confirmed as acceptable and valid in a final round, which included 8 more interviews. Linguistic adaptations of the MFIQ were also tested, and their conceptual equivalence was confirmed for all 25 language versions.
The 31 items in the MFIQ were developed to address the gaps in current patient-reported outcome instruments used to evaluate preventive treatments relevant to adults with migraine, specifically the effects of migraine on functioning. Development of the MFIQ followed recommended regulatory guidelines and best-measurement practices to demonstrate robust evidence of its content validity.
Multiple authors declare associations with the pharmaceutical industry. Please see original reference for a full list of authors’ disclosures.
Hareendran A, Skalicky A, Mannix S, et al. Development of a new tool for evaluating the benefit of preventive treatments for migraine on functional outcomes – the migraine functional impact questionnaire (MFIQ). Headache. 2018;58(10):1612-1628.