Content Validation of the NEI-VFQ-25 With Patients With Subfoveal and Non-subfoveal Geographic Atrophy: A Qualitative Study
Author(s)
Cristina Abel, MS1, Carla Dias Barbosa, MSc2, Savita Bakhshi Anand, PhD2, Patricia S. Delong, MS3, Rigel Hall, PharmD4, Seema Garg, MD, PhD4, Anthony Pepio, PhD5, Tina Damarjian, MD4, Marla Sultan, MD, MBA4, Abayomi Ogundele, PharmD4, Pamela Berry, MSc3.
1Evidera, Wilimington, NC, USA, 2Evidera, London, United Kingdom, 3Johnson & Johnson, Horsham, PA, USA, 4Johnson & Johnson, Raritan, NJ, USA, 5Johnson & Johnson, Vancouver, BC, Canada.
1Evidera, Wilimington, NC, USA, 2Evidera, London, United Kingdom, 3Johnson & Johnson, Horsham, PA, USA, 4Johnson & Johnson, Raritan, NJ, USA, 5Johnson & Johnson, Vancouver, BC, Canada.
OBJECTIVES: Geographic atrophy (GA) is a chronic, progressive degeneration of the macula that affects >5 million people worldwide. While there are FDA-approved treatments for GA, there is no patient-reported outcome measure designated as fit-for-purpose to measure quality of life in GA patients. The purpose of this qualitative study was to explore the content validity of the National Eye Institute Visual Functioning-25 item questionnaire (NEI-VFQ-25) among patients with subfoveal (SF) and non-subfoveal (NSF) GA and to understand if the measure is fit-for-purpose for use as a clinical trial (CT) endpoint in GA.
METHODS: Fifteen US-based participants (8 SF, 7 NSF) participated in cognitive debriefing interviews as part of a larger qualitative interview study.
RESULTS: The sample was mostly female, White, and non-Hispanic. All participants demonstrated a good understanding of measure instructions and appropriateness of response options. Inadequate understanding of items from 6 of 11 domains was demonstrated by 20% to <50% of study participants, including 11 overlapping items and 6 items unique to each subtype. Items were generally relevant across groups, although there were some group-level differences. Items in the general vision, driving, and near and distance activities domains were rated as most relevant across groups. Dependency domain items and social functioning domain items were rated as least relevant to the NSF and SF groups, respectively. Participants did not report any missing concepts in the measure.
CONCLUSIONS: This study indicated content validity for the NEI-VFQ-25 in a GA population. Given the differences in item relevance and interpretation across groups, revisions to the measure, including potential removal of specific domains, could be explored to increase content clarity and relevance to each GA subtype. Debriefing with a larger sample and psychometric evaluation of the measure within a CT context could be meaningful.
METHODS: Fifteen US-based participants (8 SF, 7 NSF) participated in cognitive debriefing interviews as part of a larger qualitative interview study.
RESULTS: The sample was mostly female, White, and non-Hispanic. All participants demonstrated a good understanding of measure instructions and appropriateness of response options. Inadequate understanding of items from 6 of 11 domains was demonstrated by 20% to <50% of study participants, including 11 overlapping items and 6 items unique to each subtype. Items were generally relevant across groups, although there were some group-level differences. Items in the general vision, driving, and near and distance activities domains were rated as most relevant across groups. Dependency domain items and social functioning domain items were rated as least relevant to the NSF and SF groups, respectively. Participants did not report any missing concepts in the measure.
CONCLUSIONS: This study indicated content validity for the NEI-VFQ-25 in a GA population. Given the differences in item relevance and interpretation across groups, revisions to the measure, including potential removal of specific domains, could be explored to increase content clarity and relevance to each GA subtype. Debriefing with a larger sample and psychometric evaluation of the measure within a CT context could be meaningful.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR39
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)