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 ins...

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Autores principales:	Elaheh Shirneshan, Cheryl D. Coon, Nathan Johnson, Jonathan Stokes, Ted Wells, J. Jason Lundy, David A. Andrae, Christopher J. Evans, Joanna Campbell
Formato:	article
Lenguaje:	EN
Publicado:	SpringerOpen 2021
Materias:	Presbyopia Patient-reported outcome Qualitative research Content-validity Psychometric analysis Age-related farsightedness Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/2707bc5a72a349708fd2e840db96dc72
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spelling	oai:doaj.org-article:2707bc5a72a349708fd2e840db96dc722021-12-05T12:18:52ZDevelopment of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia10.1186/s41687-021-00378-y2509-8020https://doaj.org/article/2707bc5a72a349708fd2e840db96dc722021-12-01T00:00:00Zhttps://doi.org/10.1186/s41687-021-00378-yhttps://doaj.org/toc/2509-8020Abstract 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.Elaheh ShirneshanCheryl D. CoonNathan JohnsonJonathan StokesTed WellsJ. Jason LundyDavid A. AndraeChristopher J. EvansJoanna CampbellSpringerOpenarticlePresbyopiaPatient-reported outcomeQualitative researchContent-validityPsychometric analysisAge-related farsightednessPublic aspects of medicineRA1-1270ENJournal of Patient-Reported Outcomes, Vol 5, Iss 1, Pp 1-20 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Presbyopia Patient-reported outcome Qualitative research Content-validity Psychometric analysis Age-related farsightedness Public aspects of medicine RA1-1270
spellingShingle	Presbyopia Patient-reported outcome Qualitative research Content-validity Psychometric analysis Age-related farsightedness Public aspects of medicine RA1-1270 Elaheh Shirneshan Cheryl D. Coon Nathan Johnson Jonathan Stokes Ted Wells J. Jason Lundy David A. Andrae Christopher J. Evans Joanna Campbell Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
description	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.
format	article
author	Elaheh Shirneshan Cheryl D. Coon Nathan Johnson Jonathan Stokes Ted Wells J. Jason Lundy David A. Andrae Christopher J. Evans Joanna Campbell
author_facet	Elaheh Shirneshan Cheryl D. Coon Nathan Johnson Jonathan Stokes Ted Wells J. Jason Lundy David A. Andrae Christopher J. Evans Joanna Campbell
author_sort	Elaheh Shirneshan
title	Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
title_short	Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
title_full	Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
title_fullStr	Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
title_full_unstemmed	Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia
title_sort	development of the near vision presbyopia task-based questionnaire for use in evaluating the impact of presbyopia
publisher	SpringerOpen
publishDate	2021
url	https://doaj.org/article/2707bc5a72a349708fd2e840db96dc72
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Development of the Near Vision Presbyopia Task-based Questionnaire for use in evaluating the impact of presbyopia

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