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Lippincott, Williams & Wilkins, RETINA, The Journal of Retinal and Vitreous Diseases, 1(44), p. 111-116, 2024

DOI: 10.1097/iae.0000000000003911

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Characteristics of Participants in Diabetic Retinopathy Clinical Research Clinical Trials Who Were Lost to Follow-Up

This paper was not found in any repository, but could be made available legally by the author.
This paper was not found in any repository, but could be made available legally by the author.

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Abstract

Purpose: Our study describes the racial/ethnic composition and the broad health status/severity of disease of the cohorts of Diabetic Retinopathy Clinical Research clinical trials and compares the rates of noncompletion of the trial with the first data report (lost to follow-up). Methods: This study is a retrospective cohort study of participants in Diabetic Retinopathy Clinical Research Retina Network clinical trials who met our inclusion criteria. The primary outcome was the lost to follow-up rates and their associated risk factors. Results: Eight clinical trials with 3,492 participants met our inclusion criteria. Participants who were lost to follow-up were more likely to be younger, Hispanic or Black, had Type 1 diabetes mellitus, had worse baseline best-corrected visual acuity, had higher hemoglobin A1c, had higher blood pressure, and had proliferative diabetic retinopathy (PDR) (Diabetic Retinopathy Severity Score >66). Conclusion: Participants who were lost to follow-up during Diabetic Retinopathy Clinical Research clinical trials tended to be younger, Hispanic or Black, and had worse diabetes and hypertension. This study highlights the importance of ensuring that a representative population is maintained through the end of the study period.