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A Qualitative Study to Assess the Content Validity of the 24‐Hour Migraine Quality of Life Questionnaire in Patients with Migraine

Authors
  • Speck, Rebecca M.1
  • Collins, Ethan M.1
  • Lombard, Louise2
  • Ayer, David W.2
  • 1 Evidera, USA , (United States)
  • 2 Eli Lilly & Company, USA , (United States)
Type
Published Article
Journal
Headache The Journal of Head and Face Pain
Publisher
Wiley (Blackwell Publishing)
Publication Date
Aug 03, 2020
Volume
60
Issue
9
Pages
1982–1994
Identifiers
DOI: 10.1111/head.13915
PMID: 32748408
PMCID: PMC7589320
Source
PubMed Central
Keywords
License
Unknown
External links

Abstract

Objective A concept elicitation, cognitive debriefing, and usability study was undertaken to: (1) explore migraine symptoms and day‐to‐day impacts; (2) determine the comprehensiveness and comprehensibility of the previously developed 24‐Hour Migraine Quality of Life Questionnaire electronic patient‐reported outcome (24‐Hr MQoLQ ePRO) items, and the appropriateness and understanding of the recall period, response options, and instructions; and (3) assess the usability on an electronic hand‐held device. Methods Eleven United States English‐speaking people with episodic migraine were recruited to participate in one‐on‐one interviews, which followed methods appropriate for concept elicitation, cognitive debriefing, and usability testing. Interviews were audio‐recorded, transcribed, and analyzed following the constant comparative method. Results Participants had a mean age of 42 years, and 8 were female. Through spontaneous mention or probing, all concepts of the 24‐Hr MQoLQ ePRO were endorsed by a majority of the participants. Cognitive interviewing confirmed the 24‐Hr MQoLQ ePRO instructions were clear, meaningful, and important to assess as symptoms and day‐to‐day impacts experienced as a result of migraine. Overall impressions of the ePRO device were overwhelmingly favorable, and the ePRO device was preferred to paper and pencil by all participants. Participant responses regarding the level of headache pain that would be acceptable in order to continue to go about daily activities ranged from 3 to 6, on a scale of 0 to 10, with 0 being “no headache” and 10 being “the worst headache.” Conclusions The 24‐Hr MQoLQ ePRO is content‐valid and appropriate for inclusion in future acute treatment for migraine studies designed to measure the symptoms and health‐related quality of life of migraine.

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