RELIABILITY AND CONVERGENT VALIDITY OF THE NEI VFQ-25 WITH AND WITHOUT NEAR AND DISTANCE ACTIVITY APPENDIX ITEMS IN PATIENTS WITH GEOGRAPHIC ATROPHY (GA) SECONDARY TO AGE RELATED MACULAR DEGENERATION (AMD)

Author(s)

Kapre AW1, Tschosik E1, Kimel M2, Chabi A1, Dolan C3, Sivaprasad S4, Bressler N5, Varma R6
1Genentech, South San Francisco, CA, USA, 2Evidera, Bethesda, MD, USA, 3CMD Consulting, Inc., Sandy, UT, USA, 4Moorfields Eye Hospital, London, UK, 5Johns Hopkins University School of Medicine, Baltimore, MD, USA, 6USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

OBJECTIVES: GA – an advanced, progressive and irreversible form of AMD – affects >5 million patients worldwide. This study evaluated National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) psychometrics with (NEI VFQ-25(6A)) and without (NEI VFQ-25(0A)) the 6 appendix items for Near and Distance Activity subscales in patients with GA. METHODS:  Post-hoc analyses utilized data from Mahalo, a phase 2 study of lampalizumab for GA, in which the NEI VFQ-25(6A) was administered to U.S. subjects (N=100) at 0, 6, 12, and 18 months. Psychometric properties evaluated included: internal consistency reliability (Cronbach’s α, acceptable internal consistency reliability >0.70); test-retest reliability (intra-class correlation coefficient [ICC] for patients with GA lesion growth <0.45 mmRESULTS:  Baseline Cronbach’s α for the NEI VFQ-25(6A) Composite, Near, and Distance Activity scales was 0.95, 0.84, 0.84, respectively, vs 0.93, 0.74, 0.66 for the NEI VFQ-25(0A). ICCs for the NEI VFQ-25(6A) Composite, Near, and Distance Activity scales were 0.86, 0.80, 0.84, respectively, vs 0.87, 0.77, 0.79 for the NEI VFQ-25(0A). Respective baseline Pearson r for the Composite, Near, and Distance Activity scores for the NEI VFQ-25(6A) vs (0A) were: reading speed (0.61, 0.69, 0.57 vs 0.60, 0.61, 0.50) and FRI Index (0.69, 0.73, 0.64 vs 0.68, 0.64, 0.58). CONCLUSIONS:  This analysis showed acceptable internal consistency and test-retest reliability of the NEI VFQ-25 Composite, Near, and Distance Activity scales in GA with and without the 6 appendix items. The study also indicated convergent validity with binocular measures (FRI Index, reading speed). Overall, in this population, including the appendix items enhanced the psychometric properties of the NEI VFQ-25. Further investigation of patient-reported outcome measures in this currently untreatable, blinding disease is recommended.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PSS56

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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