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. 2017 Nov 17;15(1):224.
doi: 10.1186/s12955-017-0799-1.

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)

Asha Hareendran  1 , Sally Mannix  2 , Anne Skalicky  2 , Martha Bayliss  3 , Andrew Blumenfeld  4 , Dawn C Buse  5 , Pooja R Desai  6 , Brian G Ortmeier  6 , Sandhya Sapra  6
Affiliations

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)

Asha Hareendran et al. Health Qual Life Outcomes. .

Abstract

Background: Adults 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.

Methods: The 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.

Results: The 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.

Conclusions: The results provide qualitative evidence supporting the content validity of the MPFID for evaluating outcomes of interventions for migraine.

Keywords: Cognitive interview; Content validity; Development; Diary; Disability; Functioning; Headache; Impact; Instrument; Item generation; MPFID; Migraine; Pro.

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Conflict of interest statement

Ethics approval and consent to participate

All study procedures were approved by a central Institutional Review Board (Schulman Associates IRB, Inc). All participants provided written informed consent prior to data collection procedures.

Consent for publication

Not applicable.

Competing interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or presentation of this manuscript: Sandhya Sapra, Pooja R Desai, and Brian G Ortmeier are employees and stockholders of Amgen Inc. Sally Mannix, Anne Skalicky, and Asha Hareendran are employees of Evidera. Evidera received financial support from Amgen in connection with the implementation of the study. Martha Bayliss is an employee of Optum, which has been contracted by Amgen Inc. to carry out research in connection with the implementation of the study. Andrew Blumenfeld reports consulting for Allergan, Depomed, Avanir, Pernix, Lilly, and Teva. Dawn C. Buse, PhD, has received grant support and honoraria from Allergan, Amgen, Avanir, Dr. Reddy’s, and Eli Lilly; she is an employee of Montefiore Medical Center, which has received research support funded by Allergan, Alder, Avanir, CoLucid, Dr. Reddy’s, and Labrys via grants to the National Headache Foundation and/or Montefiore Medical Center; she is on the editorial board of Current Pain and Headache Reports, the Journal of Headache and Pain, Pain Medicine News, and Pain Pathways magazine.

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Figures

Fig. 1
Fig. 1
Overview of the Flow of the Project. The MPFID was developed using an iterative process primarily based on results of qualitative interviews with adults with migraine. 1Not reported in this manuscript. See Mannix et al. [13]
Fig. 2
Fig. 2
Conceptual Framework of Version 1.0 of the MPFID. The conceptual framework comprised 17 concepts/items in 3 domain concepts representing impact on every day activities, overall impact on every day activities, and physical impairment
See this image and copyright information in PMC

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