Development and exploration of the content validity of a patient-reported outcome measure to evaluate the impact of migraine- the migraine physical function impact diary (MPFID)

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.Electronic supplementary materialThe online version of this article (10.1186/s12955-017-0799-1) contains supplementary material, which is available to authorized users.

Migraine Burden of Disease: From the Patient's Experience to a Socio‐Economic View

“…The accuracy of a migraine diagnosis and informed therapy decisions are reliant on a good understanding of patient reported symptoms and potential outcomes. Clinical and regulatory guidelines encourage the use of Patient Reported Outcome (PRO) tools, as they can capture valuable information that can be used broadly in disease management . These encompass diagnosis and screening, QoL and functional disability assessment, and finally treatment initiation, monitoring, and optimization .…”

“…These encompass diagnosis and screening, QoL and functional disability assessment, and finally treatment initiation, monitoring, and optimization . Although generic PROs can be of some use in measuring migraine burden compared with normal populations, disease‐specific PRO instruments may be of greater value . An added benefit of PROs is that they may improve communication between patients and their physicians …”

“…In theory, a person working full‐time and a person on medical leave could obtain the same scores. All PRO tools come with their own individual strengths and limitations with respect to data generation in the clinic and clinical trials . Some of these aspects are highlighted in the patient case studies covered in the Patient Cases section.…”

“…Also, none were designed to capture the impact of migraine on physical functioning and the day‐to‐day variability of the experience, as reported by patients . Therefore, a new tool called the Migraine Physical Function Impact Diary (MPFID) was developed to better assess daily impacts of migraine on physical function over the previous 24 hours . MPFID was designed to be compliant with the Food and Drug Administration's (FDA) guidelines for PROs to support label claims (the development of MIDAS, HIT‐6, and MSQ preceded this guideline's release) .…”

“…Therefore, a new tool called the Migraine Physical Function Impact Diary (MPFID) was developed to better assess daily impacts of migraine on physical function over the previous 24 hours . MPFID was designed to be compliant with the Food and Drug Administration's (FDA) guidelines for PROs to support label claims (the development of MIDAS, HIT‐6, and MSQ preceded this guideline's release) . MPFID has 13 questions that focus on the daily impact of migraine on everyday activities and on physical impairment (ie, time with difficulty moving head, body, getting out of bed, bending over, or other physical efforts) .…”