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

Abstract

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.

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“…32 The Near Activity Visual Questionnaire and Near Activity Visual Questionnaire-Presbyopia might be more sensitive to detect differences between IOLs, but they lack clinically relevant information about dysphotopsia and spectacle independence at several distances provided by questionnaires measuring other domains, such as the Quality of Vision or the Patient-Reported Spectacle Independence Questionnaire. [35][36][37] This fact explains why researchers usually use their own nonvalidated questionnaires, or they extract single questions from validated questionnaires to collect data of clinical relevance in this population. 38 The researcher should decide the validated questionnaire that better fits the domain that is intended to measure, but from a clinically relevant perspective and for enabling the between-study comparison, there are single questions for which reporting the proportion of subjects achieving a particular level in a 5-point Likert scale could be of great relevance for studies with short-term follow-ups (<6 months).…”

“…32 The Near Activity Visual Questionnaire and Near Activity Visual Questionnaire–Presbyopia might be more sensitive to detect differences between IOLs, but they lack clinically relevant information about dysphotopsia and spectacle independence at several distances provided by questionnaires measuring other domains, such as the Quality of Vision or the Patient-Reported Spectacle Independence Questionnaire. 35–37…”

Comparison of Literature Review, Social Media Listening, and Qualitative Interview Research Methods in Generating Patient-Reported Symptom and Functional Impact Concepts of Presbyopia

“…Both individuals with phakic presbyopia and HCPs who were experienced in treating presbyopia were interviewed between February 2018 and July 2019. The interviews also included cognitive debriefing of the Near Activity Vision Questionnaire Presbyopia (NAVQ-P), but those methods and findings are not the focus of the present article [ 30 ]. Ethical approval and oversight was provided by Copernicus Group Independent Review Board (CGIRB; IRB ref: ADE1-18-049), an Independent Review Board (IRB) in the US for the US interviews, prior to any study related activities in the US.…”

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“…[91][92][93] With time, we have had to develop some further to remain relevant to changing lifestyles and impact of social media, 94,95 especially the ubiquitous digital environment. 96,97 We have demonstrated that they are influenced by whether they are self-completed or the questions are posed to patients, so this needs to remain the same if scores are to be compared over time or across patients/treatments. 98 Traditional patient-reported outcome measures assess only one trait, by design, and so do not account for the patient experience of the management of their condition.…”

“…We have been involved in developing quality-of-life questionnaires for macular degeneration, 83,84 visual impairment, 85–90 and presbyopia 91–93 . With time, we have had to develop some further to remain relevant to changing lifestyles and impact of social media, 94,95 especially the ubiquitous digital environment 96,97 . We have demonstrated that they are influenced by whether they are self-completed or the questions are posed to patients, so this needs to remain the same if scores are to be compared over time or across patients/treatments 98 .…”