Abstract

BackgroundThe NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. However, important limitations which may affect the interpretation of clinical trial results have been previously identified, such as concerns with reliability and validity. The purpose of this study was to evaluate the National Eye Institute Visual Functioning Questionnaire (NEI VFQ­25) and make recommendations for a revised scoring structure, with a view to improving its psychometric performance and interpretability.MethodsRasch Measurement Theory analyses were conducted in two stages using pooled baseline NEI VFQ­25 data for 2487 participants with retinal diseases enrolled in six clinical trials. In stage 1, we examined: scale-to-sample targeting; thresholds for item response options; item fit statistics; stability; local dependence; and reliability. In stage 2, a post-hoc revision of the scoring structure (VFQ-28R) was created and psychometrically re-evaluated.ResultsIn stage 1, we found that the NEI VFQ­25 was mis-targeted to the sample, and had disordered response thresholds (15/25 items) and mis-fitting items (8/25 items). However, items appeared to be stable (differential item functioning for three items), have minimal item dependency (one pair of items) and good reliability (person-separation index, 0.93). In stage 2, the modified Rasch-scored NEI VFQ­28­R was assessed. It comprised two broad domains: Activity Limitation (19 items) and Socio-Emotional Functioning (nine items). The NEI VFQ­28­R demonstrated improved performance with fewer disordered response thresholds (no items), less item misfit (three items) and improved population targeting (reduced ceiling effect) compared with the NEI VFQ­25.ConclusionsCompared with the original version, the proposed NEI VFQ­28­R, with Rasch-based scoring and a two-domain structure, appears to offer improved psychometric performance and interpretability of the vision-related quality of life scale for the population analysed.

Highlights

  • The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population

  • The 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ25) is a patient-reported outcome (PRO) instrument originally developed for use in patients with age-related macular degeneration (AMD), cataracts, diabetic neuropathy and glaucoma [1, 2]

  • It has been widely used in clinical trials in neovascular AMD [3, 4], diabetic macular edema (DME) [5, 6], macular edema due to retinal vein occlusion (RVO) [7] and choroidal neovascularization (CNV) secondary to pathologic myopia (PM) [8]

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Summary

Introduction

The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. The 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ25) is a patient-reported outcome (PRO) instrument originally developed for use in patients with age-related macular degeneration (AMD), cataracts, diabetic neuropathy and glaucoma [1, 2]. It has been widely used in clinical trials in neovascular AMD [3, 4], diabetic macular edema (DME) [5, 6], macular edema due to retinal vein occlusion (RVO) [7] and choroidal neovascularization (CNV) secondary to pathologic myopia (PM) [8]. A more complete understanding of the content, clinical validity, and interpretability of the NEI VFQ25 is likely to be critical to regulatory acceptance of PRO-based labelling claims for new drugs and devices [7, 21]

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