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Evaluation of non-ophthalmologist-led and offline AI-assisted models for diabetic retinopathy screening in India: a pragmatic diagnostic accuracy study

bmjopen · 2026-03-18 · canonical JSON source

9 visible annotations · policy: published · automated confidence ≥ 75.00%

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Objectives To assess and compare the diagnostic accuracy of non-ophthalmologist-led diabetic retinopathy screening (DRS) at health and wellness centres (HWCs) and offline artificial intelligence (AI)-assisted community-based screening, using specialist grading as the reference standard in India.Design, settings and participants Pragmatic diagnostic accuracy study in primary healthcare settings. The settings included HWCs and community-based screening sites in rural Block Boothgarh, Mohali District, Punjab, India. A total of 600 people with diabetes aged ≥30 years were enrolled across three screening models: (1) non-ophthalmologist-led DRS at the HWC, (2) AI-assisted smartphone-based DRS in the community and (3) standard referral-based care. Retinal images were captured using non-mydriatic fundus cameras and independently graded by two masked human graders; a senior retina specialist resolved any disagreements. The AI was assessed for its ability to detect diabetic retinopathy (DR) and referable diabetic retinopathy (RDR). Diagnostic performance metrics were reported.Results The non-ophthalmologist-led model demonstrated 86.4% sensitivity (95% CI 65.1% to 97.1%) and 94.3% specificity (95% CI 88.5% to 97.7%) for DR detection, with an ungradability rate of 8%. For RDR, sensitivity reached 95.8% (95% CI 78.9% to 99.9%) and specificity was 93.1% (95% CI 88.0% to 96.5%). The offline AI-assisted model achieved 93.3% sensitivity (95% CI 68.1% to 99.8%) and 85.1% specificity (95% CI 76.9% to 91.2%) for RDR, but with a higher ungradability rate (38%), mainly due to cataracts and poor image quality. Both approaches effectively identified referable cases; however, the non-ophthalmologist-led model demonstrated greater accuracy and operational feasibility.Conclusions This study demonstrates that non-ophthalmologist-led DRS at HWCs can enhance access to primary care. Offline AI-enabled screening demonstrates potential for community use but is currently limited by image quality and binary classification outputs. Integrating both approaches may strengthen DRS coverage in resource-limited settings.Clinical trials registry of India CTRI/2022/10/046283.