Evaluation of the content validity of patient-reported outcome (PRO) instruments developed for use with individuals with phakic presbyopia, including the Near Activity Visual Questionnaire-presbyopia (NAVQ-P) and the near vision correction independence (NVCI) instrument


Background: Presbyopia is the age-related deterioration in the ability to focus on close objects. In order to develop a patient-reported outcome (PRO) instrument to assess near vision functioning, the Near Activity Visual Questionnaire (NAVQ) was adapted to incorporate modern technology (e.g. smartphones) and to be appropriate for use in phakic presbyopia, leading to the development of the NAVQ-Presbyopia (NAVQ-P). Additional single-item instruments of near vision correction independence (NVCI), correction preference (NVCP), and vision satisfaction (NVS) were also developed. The study aimed to evaluate the content validity of the NAVQ-P and additional instruments in individuals with phakic presbyopia. Methods: Participants in the US (n = 15), Germany (n = 10) and France (n = 10) took part in face-to-face, qualitative, cognitive debriefing interviews. Seven healthcare professionals (HCPs) were also interviewed to assess the clinical relevance of the PRO instruments. Interviews started with open-ended qualitative concept elicitation questioning; participants then completed the PRO instruments on an electronic tablet using a “think-aloud” process and were asked about their understanding and relevance of each item, instruction, response scale and recall period. Interviews were conducted in two rounds allowing for modifications between rounds. Results: The participants interpreted the majority of the PRO instruments and recall period correctly and consistently. They were able to select an appropriate response option without difficulty. Minor modifications were made to the PRO instruments based on interview findings. Instruction/item wording was modified to include reference to use of a magnifying glass, in addition to glasses and contact lenses. Two items were added to assess difficulty with precision tasks (e.g. sewing) and taking longer to adjust from distance to near vision. HCPs confirmed the relevance of the concepts being measured for presbyopia and recommended the addition of an item assessing contrast sensitivity. Conclusions: Developed in accordance with the FDA PRO Guidance, the findings support content validity of the NAVQ-P as a suitable, well-understood instrument of relevant near vision functioning concepts in individuals with phakic presbyopia. The NVCI and additional PRO instruments are appropriate to assess near vision correction independence, correction preference, and vision satisfaction. Future work will assess the psychometric properties of the NAVQ-P and additional PRO instruments.

Publication DOI: https://doi.org/10.1186/s41687-021-00379-x
Divisions: College of Health & Life Sciences > School of Optometry > Optometry
College of Health & Life Sciences > School of Optometry > Optometry & Vision Science Research Group (OVSRG)
College of Health & Life Sciences
Funding Information: JW is a developer of the original NAVQ and has been engaged with Novartis on other projects and has received honoraria for speaker events, ad boards and other related activities. RA, SB, and AF are employed by Adelphi Values Patient-Centered Outcomes team
Additional Information: © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Uncontrolled Keywords: Cognitive debriefing,Content validity,Interviews,NAVQ-P,Patient-reported outcome,Presbyopia,Qualitative,Health Informatics,Health Information Management
Publication ISSN: 2509-8020
Last Modified: 14 May 2024 17:49
Date Deposited: 03 Nov 2021 15:05
Full Text Link:
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
https://jpro.sp ... 687-021-00379-x (Publisher URL)
PURE Output Type: Article
Published Date: 2021-10-23
Accepted Date: 2021-09-15
Authors: Bentley, Sarah
Findley, Amy
Chiva-Razavi, Sima
Naujoks, Christel
Patalano, Francesco
Johnson, Chloe
Arbuckle, Rob
Wolffsohn, James S. (ORCID Profile 0000-0003-4673-8927)



Version: Published Version

License: Creative Commons Attribution

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