Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia

Abstract

Background: Presbyopia is a progressive condition that reduces the eye's ability to focus on near objects with increasing age. After a systematic literature review identified no existing presbyopia-specific patient-reported outcome (PRO) instruments meeting regulatory guidance, a new PRO instrument, the Near Vision Presbyopia Task-based Questionnaire (NVPTQ), was developed.

Results: To explore the patient experience with presbyopia, concept elicitation interviews were conducted with 20 presbyopic participants. The most frequently reported impacts were difficulty with reading menus/books/newspapers/magazines, reading on a cell phone/caller ID, and reading small print. Based on these results, a task-based PRO instrument (the NVPTQ) was developed instructing participants to complete four near-vision, paper-based reading tasks (book, newspaper, nutrition label, menu) under standardized settings, and subsequently assess their vision-related reading ability and associated satisfaction. The draft NVPTQ was cognitively debriefed with a sample of 20 presbyopes, which demonstrated that most participants interpreted the items as intended and endorsed the relevance of the concepts being assessed. After the qualitative research, the draft instrument was psychometrically tested using data from a Phase 2 study. Based on item-level analyses, all items in the NVPTQ demonstrated expected response option patterns and lacked substantial floor or ceiling effects. The reliability, validity, and responsiveness of the NVPTQ Performance and Satisfaction domain scores were assessed. All domains scores had large Cronbach's coefficient α values and good test-retest statistics, indicating that the scores are internally consistent and produce stable values over time. The pattern of correlations with a concurrent measure of visual functioning (National Eye Institute Visual Function Questionnaire 25) demonstrated that the NVPTQ domain scores were related to an alternative assessment of near-vision activities. The NVPTQ domain scores were able to distinguish between groups that were known to differ on the clinical outcome of uncorrected near visual acuity, supporting the construct validity of these scores. The NVPTQ domain scores showed evidence of responsiveness to change by being able to distinguish between groups defined as improved and not improved based on patient-reported and clinical outcomes.

Conclusions: This research has resulted in a content-valid and psychometrically sound instrument designed to evaluate vision-related reading ability and satisfaction with vision-related reading ability.

Trial registration: ClinicalTrials.gov NCT02780115. Registered 23 May 2016, https://www.clinicaltrials.gov/ct2/show/NCT02780115?term=NCT02780115&draw=2&rank=1.

Keywords: Age-related farsightedness; Content-validity; Patient-reported outcome; Presbyopia; Psychometric analysis; Qualitative research.

Conflict of interest statement

ES, JS, and JC are employees of AbbVie Inc. CDC and JJL are employees of Outcometrix. NJ, TW, DAA, and CJE are employees of Endpoint Outcomes.

© 2021. The Author(s).

Figures

Fig. 1

Nominal item characteristic curves for the Performance + Squinting testlet for reading a book. Note Curves are based on data from at Day 28 Hour 1 and correspond to the testlet responses as defined in Table 4

Fig. 2

Nominal item characteristic curves for the Satisfaction + Squinting testlet for reading a book. Note Curves are based on data from at Day 28 Hour 1 and correspond to the testlet responses as defined in Table 4

Fig. 3

Graded item characteristic curves for the Performance + Squinting testlets. Note Curves are based on data from at Day 28 Hour 1 and correspond to the testlet responses as defined in Table 5

Fig. 4

Graded item characteristic curves for the Satisfaction + Squinting testlets. Note Curves are based on data from at Day 28 Hour 1 and correspond to the testlet responses as defined in Table 5

Fig. 5

Near Vision Presbyopia Task-based Questionnaire Conceptual Framework. ©2021 AbbVie. All rights reserved

Fig. 6

eCDF of change in NVPTQ Performance by PGIC. Note Change is computed as Day 28 Hour 1 minus Day 1 Hour 0. Positive scores indicate improvement. eCDF, empirical cumulative distribution; NVPTQ, Near Vision Presbyopia Task-based Questionnaire; PGIC, Patient Global Impression of Change

Fig. 7

eCDF of change in NVPTQ Performance by change in UNVA. Note Change is computed as Day 28 Hour 1 minus Day 1 Hour 0. Positive scores indicate improvement. eCDF, empirical cumulative distribution; NVPTQ, Near Vision Presbyopia Task-based Questionnaire; UNVA, uncorrected near visual acuity

Fig. 8

eCDF of change in NVPTQ Satisfaction by PGIC. Note Change is computed as Day 28 Hour 1 minus Day 1 Hour 0. Positive scores indicate improvement. eCDF, empirical cumulative distribution; NVPTQ, Near Vision Presbyopia Task-based Questionnaire; PGIC, Patient Global Impression of Change

Fig. 9

eCDF of change in NVPTQ Satisfaction by change in UNVA. Note Change is computed as Day 28 Hour 1 minus Day 1 Hour 0. Positive scores indicate improvement. eCDF, empirical cumulative distribution; NVPTQ, Near Vision Presbyopia Task-based Questionnaire; UNVA, uncorrected near visual acuity