Diabetic Retinopathy Screening in Primary Care Real Practice: Study Procedures and Baseline Characteristics from the RETINAvalid Project

Background/Objectives: With rising diabetes rates, early detection of complications such as diabetic retinopathy (DR), a leading cause of visual impairment, is crucial. Incorporating DR screening into primary care has shown positive results, and integrating technological advances and artificial intelligence (AI) into these processes offers promising potential. The overall study aims to evaluate the agreement between primary care physicians, ophthalmologists, and an AI system in DR screening and referral decisions within a real-world primary care setting. Methods: In this brief report, we present the study protocol and provide an initial overview and description of our sample. A total of 1517 retinographies, obtained by a non-mydriatic retinal camera, were retrospectively collected from 301 patients with diabetes. Results: Primary care physicians referred 34.5% of the patients to ophthalmology, primarily due to opacification, suspicion of DR, or other retinal diseases. Overall, 13.62% of the participants were suspected of having DR, with 9.63% having a definitive diagnosis. Conclusions: These initial descriptive findings will be further explored in the next phase of the study through the analysis of concordance between primary care physicians, the AI-based software, and ophthalmology specialists. Future results are expected to provide valuable insights into the reliability of DR screening across different evaluators and support the integration of effective DR screening strategies into real-world clinical practice.