Measuring Quality of Life in Diabetic Retinal Disease: A Narrative Review of Available Patient-Reported Outcome Measures
Stela Vujosevica b✉, Emily Y. Chewc d, Leanne T. Labriolae f g h, Sobha Sivaprasadi j, Ecosse Luc Lamoureuxk l
- aDepartment of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy
- bEye Clinic, IRCCS MultiMedica, Milan, Italy
- cDivision of Epidemiology and Clinical Applications, Clinical Trials Branch, National Eye Institute, National Institutes of Health, Bethesda, Maryland
- dDivision of Epidemiology and Clinical Applications, Clinical Trials Branch, National Eye Institute, National Institutes of Health, Bethesda, MD, USA
- eOphthalmology Department, Carle Foundation Hospital, Urbana, Illinois
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Abstract
Topic Several patient-reported outcome measures (PROMs) are available to measure health-related quality of life (HRQoL) in patients with late-stage clinical diabetic retinal diseases (DRDs). However, an understanding of the psychometric properties of PROMs is needed to assess how they could relate to severity levels of a revised DRD grading system. This narrative review assessed the available generic-, vision-, and DRD-related PROMs used in DRD research and highlights areas for improvement. Clinical Relevance Diabetic retinal disease is a common complication of diabetes and can lead to sight-threatening complications with a devastating effect on HRQoL. Methods The Quality of Life working group is one of 6 working groups organized for the DRD Staging System Update Effort, a project of the Juvenile Diabetes Research Foundation Mary Tyler Moore Vision Initiative. PubMed, Cochrane Library, Embase, and Google Scholar databases were searched using core keywords to retrieve ophthalmology-related review articles, randomized clinical trials, and prospective, observational, and cross-sectional studies in the English language. A detailed review of 12 PROMs (4 QoL questionnaires and 8 utilities) that met a minimum level of evidence (LOE) was conducted. The relevance of each PROM to DRD disease stage and Biomarker Qualification guidelines (Biomarkers, EndpointS, and other Tools) categories was also defined. Results The National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25), Impact of vision impairment-computerized adaptive testing, and Diabetic Retinopathy and Macular Edema Computerized Adaptive Testing System had a LOE of II in detecting change due to late-stage DRD (diabetic macular edema), although several areas for improvement (e.g., psychometrics and generalizability) were identified. Other PROMs, particularly the utilities, had a LOE of III due to cross-sectional evidence in late-stage clinical DRD. Although the NEI VFQ-25 has been the most widely used PROM in late-stage DRD, more work is required to improve its multidimensional structure and other psychometric limitations. No PROM was deemed relevant for subclinical or early/mid-DRD. Conclusion This narrative review found that the most commonly used PROM is NEI VFQ-25, but none meets the ideal psychometric, responsiveness, and clinical setting digital administration requirements that could be included in an updated DRD staging system for diagnosis and monitoring of DRD progression. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
TL;DRIt is found that the most commonly used PROM is NEI VFQ-25, but none meets the ideal psychometric, responsiveness, and clinical setting digital administration requirements that could be included in an updated DRD staging system for diagnosis and monitoring of DRD progression.