Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items


Background: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). Methods: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. Results: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0–42) was recommended, including a more specific responder definition of 10-point improvement. Conclusions: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

Publication DOI:
Divisions: College of Health & Life Sciences > School of Optometry > Optometry & Vision Science Research Group (OVSRG)
College of Health & Life Sciences
College of Health & Life Sciences > School of Optometry > Optometry
Additional Information: Publisher Copyright: © The Author(s) 2024.
Uncontrolled Keywords: Presbyopia,Clinical outcome assessment,Psychometric validation,Near vision function,Patient-reported outcome
Publication ISSN: 2509-8020
Data Access Statement: The data that support the findings of this study are available from Novartis<br/>Pharma AG but restrictions apply to the availability of these data, which were<br/>used under license for the current study, and so are not publicly available.<br/>Data are however available from the authors upon reasonable request and<br/>with the permission of Christel Naujoks<br/>The authors wish to extend their thanks to Francesca Toffolo for her support<br/>with the acquisition and analysis of the data, also to Samiar Ashtiany for his<br/>support with the data analysis and to Anjali Batish and Louise O’Hara for their<br/>support with the interpretation of the data and with their help to draft the<br/>article.
Last Modified: 03 Jul 2024 07:20
Date Deposited: 15 Apr 2024 12:56
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Related URLs: https://jpro.sp ... 687-024-00717-9 (Publisher URL)
http://www.scop ... tnerID=8YFLogxK (Scopus URL)
PURE Output Type: Article
Published Date: 2024-04-09
Published Online Date: 2024-04-09
Accepted Date: 2024-03-18
Submitted Date: 2023-11-17
Authors: Sims, Joel
Sloesen, Brigitte
Bentley, Sarah
Naujoks, Christel
Arbuckle, Rob
Chiva-Razavi, Sima
Pascoe, Ben
Stochl, Jan
Findley, Amy
O’Brien, Paul
Wolffsohn, James S. (ORCID Profile 0000-0003-4673-8927)



Version: Published Version

License: Creative Commons Attribution

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