Measuring Quality of Life in Diabetic Retinal Disease: A Narrative Review of Available Patient-Reported Outcome Measures
Stela Vujosevic, Emily Y. Chew, Leanne T. Labriola, Sobha Sivaprasad, Ecosse L. Lamoureux
Abstract
TopicSeveral patient-reported outcome measures (PROMs) are available to measure health-related quality of life (HRQoL) in patients with late stage clinical diabetic retinal diseases (DRD). 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 assesses the available generic-, vision- and DRD-related PROMs used in DRD research and highlights areas for improvement.Clinical relevanceDRD is a common complication of diabetes and can lead to sight-threatening complications with a devastating effect on HRQoL.MethodsThe Quality of Life working group is one of six working groups organized for the DRD Staging System Update Effort, a project of the “Juvenile Diabetes Research Foundation (JDRF) Mary Tyler Moore Vision Initiative”. PubMed, Cochrane Library, Embase and Google Scholar databases were searched using core keywords. Ophthalmology related review papers, randomized clinical trials, and prospective, observational, and cross-sectional studies in English language and a detailed review of 12 PROMs (4 QoL questionnaires; 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 (BEST) categories was also defined.ResultsThe NEI VFQ-25, IVI-CAT and RetCAT had a level of evidence (LOE) of II in detecting change due to late stage DRD (diabetic macular edema), although several areas for improvement (e.g. psychometrics and generalisability) were identified. Other PROMs, particularly the utilities, had a LOE of III due to cross-sectional evidence in late stage clinical DRD. While 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.ConclusionThis narrative review found that the most commonly used PROM is NEI VFQ-25 but none meets the ideal psychometric, responsiveness, and real-world digital adminstration requirements that could be included in an updated DRD staging system, for diagnosis and monitoring of DRD progression. 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 (DRD). 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 assesses the available generic-, vision- and DRD-related PROMs used in DRD research and highlights areas for improvement. DRD is a common complication of diabetes and can lead to sight-threatening complications with a devastating effect on HRQoL. The Quality of Life working group is one of six working groups organized for the DRD Staging System Update Effort, a project of the “Juvenile Diabetes Research Foundation (JDRF) Mary Tyler Moore Vision Initiative”. PubMed, Cochrane Library, Embase and Google Scholar databases were searched using core keywords. Ophthalmology related review papers, randomized clinical trials, and prospective, observational, and cross-sectional studies in English language and a detailed review of 12 PROMs (4 QoL questionnaires; 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 (BEST) categories was also defined. The NEI VFQ-25, IVI-CAT and RetCAT had a level of evidence (LOE) of II in detecting change due to late stage DRD (diabetic macular edema), although several areas for improvement (e.g. psychometrics and generalisability) were identified. Other PROMs, particularly the utilities, had a LOE of III due to cross-sectional evidence in late stage clinical DRD. While 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. This narrative review found that the most commonly used PROM is NEI VFQ-25 but none meets the ideal psychometric, responsiveness, and real-world digital adminstration requirements that could be included in an updated DRD staging system, for diagnosis and monitoring of DRD progression.