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, Sally Mannix, Anne Skalicky, Martha Bayliss, Andrew Blumenfeld, Dawn C. Buse, Pooja R. Desai, Brian G. Ortmeier, Sandhya Sapra

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 24h 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.

Original languageEnglish (US)
Article number224
JournalHealth and Quality of Life Outcomes
Volume15
Issue number1
DOIs
StatePublished - Nov 17 2017

Fingerprint

Migraine Disorders
Interviews
Aptitude
Patient Reported Outcome Measures
Physical Exertion
Appointments and Schedules

Keywords

  • Cognitive interview
  • Content validity
  • Development
  • Diary
  • Disability
  • Functioning
  • Headache
  • Impact
  • Instrument
  • Item generation
  • Migraine
  • MPFID
  • Pro

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

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). / Hareendran, Asha; Mannix, Sally; Skalicky, Anne; Bayliss, Martha; Blumenfeld, Andrew; Buse, Dawn C.; Desai, Pooja R.; Ortmeier, Brian G.; Sapra, Sandhya.

In: Health and Quality of Life Outcomes, Vol. 15, No. 1, 224, 17.11.2017.

Research output: Contribution to journalArticle

Hareendran, Asha ; Mannix, Sally ; Skalicky, Anne ; Bayliss, Martha ; Blumenfeld, Andrew ; Buse, Dawn C. ; Desai, Pooja R. ; Ortmeier, Brian G. ; Sapra, Sandhya. / 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). In: Health and Quality of Life Outcomes. 2017 ; Vol. 15, No. 1.
@article{7f5a768f8b24448b92dd2385dabc5b2e,
title = "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 = "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 24h 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, Migraine, MPFID, Pro",
author = "Asha Hareendran and Sally Mannix and Anne Skalicky and Martha Bayliss and Andrew Blumenfeld and Buse, {Dawn C.} and Desai, {Pooja R.} and Ortmeier, {Brian G.} and Sandhya Sapra",
year = "2017",
month = "11",
day = "17",
doi = "10.1186/s12955-017-0799-1",
language = "English (US)",
volume = "15",
journal = "Health and Quality of Life Outcomes",
issn = "1477-7525",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - 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)

AU - Hareendran, Asha

AU - Mannix, Sally

AU - Skalicky, Anne

AU - Bayliss, Martha

AU - Blumenfeld, Andrew

AU - Buse, Dawn C.

AU - Desai, Pooja R.

AU - Ortmeier, Brian G.

AU - Sapra, Sandhya

PY - 2017/11/17

Y1 - 2017/11/17

N2 - 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 24h 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.

AB - 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 24h 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.

KW - Cognitive interview

KW - Content validity

KW - Development

KW - Diary

KW - Disability

KW - Functioning

KW - Headache

KW - Impact

KW - Instrument

KW - Item generation

KW - Migraine

KW - MPFID

KW - Pro

UR - http://www.scopus.com/inward/record.url?scp=85034092505&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85034092505&partnerID=8YFLogxK

U2 - 10.1186/s12955-017-0799-1

DO - 10.1186/s12955-017-0799-1

M3 - Article

AN - SCOPUS:85034092505

VL - 15

JO - Health and Quality of Life Outcomes

JF - Health and Quality of Life Outcomes

SN - 1477-7525

IS - 1

M1 - 224

ER -