Enterprise AI Analysis
Diabetic Retinopathy Screening in Primary Care Real Practice: Study Procedures and Baseline Characteristics from the RETINAvalid Project
The RETINAvalid Project aims to evaluate diabetic retinopathy (DR) screening in primary care, focusing on concordance between primary care physicians (PCPs), ophthalmologists, and an AI system. This brief report details the study protocol and baseline characteristics of 301 diabetes patients, from whom 1517 retinographies were collected. PCPs referred 34.5% of patients to ophthalmology due to opacification, suspected DR, or other retinal issues. Overall, 13.62% of participants were suspected of having DR, with 9.63% receiving a definitive diagnosis. Future phases will analyze concordance to assess the reliability of DR screening across different evaluators and support the integration of effective DR screening strategies into real-world clinical practice.
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Context of the Study
Diabetic retinopathy (DR) is a major complication of diabetes and a leading cause of blindness. Early detection through screening is crucial. Integrating DR screening into primary care, using retinography, and leveraging AI holds significant potential to improve diagnosis and patient management while reducing healthcare workload.
Study Methodology
The RETINAvalid Study is a retrospective study conducted in Northern Metropolitan Area of Barcelona, Spain. It evaluates inter-observer concordance in DR screening using retinography among primary care physicians, ophthalmology specialists, and an AI software. Participants were adults (≥18 years old) with T1D or T2D, who underwent screening retinography within the previous six years. Exclusion criteria included conditions affecting decision-making capacity or retinography quality (e.g., severe cataracts, high myopia). Data collected included sociodemographic, clinical (diabetes type, duration, HbA1c, treatments, comorbidities), and retinography reports (PCP assessment, referral reasons, ophthalmology diagnosis). Retinographies were anonymized. Ophthalmology specialists will independently evaluate images for quality and DR/DME classification, with a third specialist resolving disagreements to establish a gold standard. An AI system (UMI DR v1.0.0) will also assess images for moderate NPDR or more severe stages. The study requires 625 retinographies for planned concordance analyses.
Key Study Results
From 329 individuals, 301 (91.5%) subjects were included, yielding 1517 retinographies (average 4.67 per patient) over six years. The study population was predominantly older adults (mean age 70.3 years) with type 2 diabetes (99.3%), and a mean disease duration of 12.8 years. Mean HbA1c was 7.4%. Hypertension was highly prevalent (74.7%), and 12.3% had coronary disease. PCPs referred 34.5% of patients to ophthalmology. Reasons for referral included opacification (14.7%), suspicion of DR (5.51% of those not diagnosed with DR, but 58.6% of those with a DR diagnosis), and other retinal diseases. Overall, DR was suspected in 13.62% of patients, with 9.63% receiving a definitive diagnosis. 82.7% of patients diagnosed with DR were referred to ophthalmology by PCPs.
Discussion and Implications
The study's preliminary results align with previous Spanish studies regarding DR prevalence and referral rates. The mean age and high prevalence of T2D reflect demographic trends. The observed HbA1c (7.4%) is acceptable for older patients with individualized glycemic goals. High prevalence of hypertension (74.7%) and coronary disease (12.3%) aligns with known diabetes comorbidities, emphasizing integrated care. The average abdominal perimeter (103.8 cm) suggests elevated cardiovascular risk. Diet (71.4% receiving recommendations) and non-smoking (55.8%) indicate lifestyle focus. The 34.5% referral rate is consistent with other studies, highlighting retinography's value beyond DR detection for other retinal pathologies. The effective identification and referral of 82.7% of DR-diagnosed patients by PCPs is positive. The study emphasizes the future analysis of concordance between PCPs, ophthalmologists, and AI to improve diagnostic consistency, streamline workflows, and enhance patient outcomes, leveraging telemedicine and AI's potential in DR screening.
Enterprise Process Flow
| Reason | No DR Diagnosis (n=272) | DR Diagnosis (n=29) |
|---|---|---|
| No referral | 192 (70.6%) | 5 (17.2%) |
| Suspicion of Diabetic Retinopathy | 15 (5.51%) | 17 (58.6%) |
| Opacification | 40 (14.7%) | 3 (1.10%) |
| Other retinal diseases | 14 (5.15%) | 0 (0.00%) |
| More than one reason | 9 (3.31%) | 4 (1.47%) |
Leveraging AI for Enhanced DR Screening
The study aims to evaluate an AI-based system (UMI DR v1.0.0) for automated retinography reading. This system has shown high diagnostic performance in previous validation studies, achieving 95.69% sensitivity and 94.44% specificity for detecting more than mild DR. Its integration into screening workflows could standardize diagnostic processes, enhance efficiency, and reduce workload for both primary care physicians and ophthalmologists. This will improve patient care by ensuring timely detection and appropriate referrals.
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