Abstract
BackgroundAdults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of interventions for migraine.MethodsThe conceptual framework and items for a new patient-reported outcome (PRO) instrument, the Migraine Physical Function Impact Diary (MPFID), were developed using scientific methods recommended to ensure content validity of PRO instruments. The MPFID was developed to measure the impact of migraine on physical functioning based on themes raised in concept elicitation (CE) interviews (conducted previously) with adults with migraine. Cognitive interviews were conducted with adults with migraine to further explore content validity. The instrument was modified following an interim analysis of a first round of cognitive interviews, to assess comprehensiveness and clarity of items, instructions, and response options. Refinements were subsequently tested in additional cognitive interviews.ResultsThe conceptual framework included impacts on physical functioning experienced by most adults with migraine and deemed clinically relevant for measuring the outcome of an intervention for migraine. Concepts in the framework included the impact of migraine on physical impairments (acts) and ability to complete day-to-day activities and perform everyday activities (tasks). MPFID items were generated to evaluate functioning over the past 24 h and to collect data daily, to capture experiences on days with migraine as well as the days in-between migraines. Items asked about needing to rest or lie down; ability to get out of bed, stand up, bend over, walk, perform household chores, do tasks outside the home, keep routines or schedules, get ready for the day, do activities that require concentration or clear thinking; difficulty moving head and body, doing activities requiring physical effort; avoiding interacting with others. Initial modifications based on the first round of cognitive interviews (n = 8) included clarifying instructions, updating three items to enhance specificity and clarity, and revising one item to include gender-neutral language. The second round of interviews (n = 9) confirmed acceptability of revisions and supported content validity.ConclusionsThe results provide qualitative evidence supporting the content validity of the MPFID for evaluating outcomes of interventions for migraine.
Highlights
Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks
Migraine experts highlighted the need to avoid concepts that were not necessarily an impact of migraine but potentially a result of co-morbid conditions, which may result from many aspects of patients’ physical and mental health and may not be directly attributed to a migraine
These dimensions of the conceptual framework were used to guide the development of the initial versions of the Migraine Physical Function Impact Diary (MPFID)
Summary
Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Adults with migraine experience recurrent headaches lasting four to 72 h, often with unilateral, pulsating, moderate or severe headache, frequently aggravated by routine physical activity [1]. In addition to these symptoms, people with migraine experience significant headache-related disability including substantial reductions in their quality of life in comparison with the general population [2,3,4,5,6,7], absenteeism from work or school [8, 9], and reduced productivity due to migraine when at work or school [10]. Acts and tasks were the key components of the ‘activity component’ of the ICF as clarified by Badley [14]
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