Content identification for the multifocal contact lens patient‐reported outcomes (MCL‐PRO) instrument item bank

Abstract

AbstractPurpose: Patient‐reported outcomes (PROs) have become remarkably important in the optometric field and now, are essential for healthcare clinical trial end points. However, being presbyopia an important topic in this field and multifocal contact lenses an increasingly popular method for its correction, no comprehensive, patient‐relevant, and precise multifocal contact lens specific PRO is available. Therefore, the purpose of this study was to identify content for the new Multifocal Contact Lens Patient‐reported Outcomes (MCL‐PRO) item bank.Methods: Four phases were conducted to identify the content: (1) Qualitative review of the literature and existing PRO optometric instruments; (2) Focus groups with presbyopic patients and optometric experts; (3) Review of social media on the subject; (4) Classification and selection of items.Results: A total of 305 unique items (extant items from PRO instruments and literature review, 53; patient focus group 192; experts focus group 47; social media review 9) were identified. The items were classified in 9 domains: Activity limitation (34 items); Visual symptoms (99 items); General symptoms (7 items); Ocular surface symptoms (48 items); Convenience (45 items); Emotional well‐being (40 items); Economic issues (10 items); Social issues (12 items); Cognitive issues (6 items).Conclusions: After a rigorous systematic identification of the content of topics important to the presbyopic population, 9 main domains were found. Most of the selected elements were identified from patient focus groups in the hope of getting as close as possible to the evaluation from the patient's point of view.