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- Qualitative Development of a Patient-Reported Outcome to Assess Comfort and Ease of Handling in Children Using Soft Contact Lenses
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Board # 38
215037
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Alex Nixon, OD, MS, FAAO
Johnson and Johnson Vision
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Vrushali Korde, PhD
Johnson and Johnson Vision
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Jie Xu, PhD
Johnson and Johnson Vision
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Robert Morlock, PhD
PRO-Spectus
PURPOSE
Multifocal soft contact lenses (MFSCLs) have been demonstrated to slow myopia progression in children through randomized controlled trials.1,2 Beyond myopia control efficacy, which has clear objective endpoints, other factors, such as contact lens comfort and handling, will contribute to successful fitting outcomes and wearing experiences, potentially promoting treatment adherence. The Pediatric Refractive Error Profile (PREP) has been widely used to assess the subjective experience of contact lens wear versus glasses in children,3–5 but lacks published qualitative research and was not developed to assess comparative soft lens performance. The purpose of this study was to evaluate the comprehension, relevance, and usability of a novel patient-reported outcome (PRO) assessing contact lens comfort and ease of handling in children wearing soft contact lenses.
METHODS
Clinician, parent and pediatric patient participants who met study inclusion/exclusion criteria were recruited from sites who fit children with soft contact lenses. An experienced interviewer conducted 1-on-1 online interviews facilitated by a semi-structured interview guide. Concept elicitation interviews were conducted to identify important concepts, develop items, and inform conceptual framework; cognitive debriefing interviews were used to ensure the relevance, appropriateness, comprehension, and interpretability. Findings from the qualitative thematic analysis of verbatim interview transcripts contributed to the development and modification of PRO items.
RESULTS
5 clinicians, 14 parents and 19 pediatric patient participants (age 7-15) were interviewed. Clinicians identified constructs related to comfort which are important to pediatric patients’ evaluation of the lenses and also noted that younger, neophyte contact lens wearers may experience transient, initial difficulty with lens application or removal. The patient and parent interviews helped confirm the importance of the constructs and shared their experiences. They also noted that addressing overall comfort, not just the constructs, would be helpful . These interviews shaped the content and led to revisions making individual items easier to read and understand.
CONCLUSION
Qualitative input was used to develop a novel PRO measure to assess comfort and ease of handling in children wearing soft contact lenses. The items are relevant and understandable for subjects 7-15 years old. Data is needed to assess the frequency these constructs are experienced during pediatric soft contact lens wear and for psychometric evaluation of the new PRO measure.
Multifocal soft contact lenses (MFSCLs) have been demonstrated to slow myopia progression in children through randomized controlled trials.1,2 Beyond myopia control efficacy, which has clear objective endpoints, other factors, such as contact lens comfort and handling, will contribute to successful fitting outcomes and wearing experiences, potentially promoting treatment adherence. The Pediatric Refractive Error Profile (PREP) has been widely used to assess the subjective experience of contact lens wear versus glasses in children,3–5 but lacks published qualitative research and was not developed to assess comparative soft lens performance. The purpose of this study was to evaluate the comprehension, relevance, and usability of a novel patient-reported outcome (PRO) assessing contact lens comfort and ease of handling in children wearing soft contact lenses.
METHODS
Clinician, parent and pediatric patient participants who met study inclusion/exclusion criteria were recruited from sites who fit children with soft contact lenses. An experienced interviewer conducted 1-on-1 online interviews facilitated by a semi-structured interview guide. Concept elicitation interviews were conducted to identify important concepts, develop items, and inform conceptual framework; cognitive debriefing interviews were used to ensure the relevance, appropriateness, comprehension, and interpretability. Findings from the qualitative thematic analysis of verbatim interview transcripts contributed to the development and modification of PRO items.
RESULTS
5 clinicians, 14 parents and 19 pediatric patient participants (age 7-15) were interviewed. Clinicians identified constructs related to comfort which are important to pediatric patients’ evaluation of the lenses and also noted that younger, neophyte contact lens wearers may experience transient, initial difficulty with lens application or removal. The patient and parent interviews helped confirm the importance of the constructs and shared their experiences. They also noted that addressing overall comfort, not just the constructs, would be helpful . These interviews shaped the content and led to revisions making individual items easier to read and understand.
CONCLUSION
Qualitative input was used to develop a novel PRO measure to assess comfort and ease of handling in children wearing soft contact lenses. The items are relevant and understandable for subjects 7-15 years old. Data is needed to assess the frequency these constructs are experienced during pediatric soft contact lens wear and for psychometric evaluation of the new PRO measure.
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