Abstract
PURPOSE: This trial was designed to determine if artificial intelligence (AI)-supported diabetic retinopathy (DR) screening improved referral uptake in Rwanda. DESIGN: The Rwanda Artificial Intelligence for Diabetic Retinopathy Screening (RAIDERS) study was an investigator-masked, parallel-group randomized controlled trial. PARTICIPANTS: Patients ≥ 18 years of age with known diabetes who required referral for DR based on AI interpretation. METHODS: The RAIDERS study screened for DR using retinal imaging with AI interpretation implemented at 4 facilities from March 2021 through July 2021. Eligible participants were assigned randomly (1:1) to immediate feedback of AI grading (intervention) or communication of referral advice after human grading was completed 3 to 5 days after the initial screening (control). MAIN OUTCOME MEASURES: Difference between study groups in the rate of presentation for referral services within 30 days of being informed of the need for a referral visit. RESULTS: Of the 823 clinic patients who met inclusion criteria, 275 participants (33.4%) showed positive findings for referable DR based on AI screening and were randomized for inclusion in the trial. Study participants (mean age, 50.7 years; 58.2% women) were randomized to the intervention (n = 136 [49.5%]) or control (n = 139 [50.5%]) groups. No significant intergroup differences were found at baseline, and main outcome data were available for analyses for 100% of participants. Referral adherence was statistically significantly higher in the intervention group (70/136 [51.5%]) versus the control group (55/139 [39.6%]; P = 0.048), a 30.1% increase. Older age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.02-1.05; P < 0.0001), male sex (OR, 2.07; 95% CI, 1.22-3.51; P = 0.007), rural residence (OR, 1.79; 95% CI, 1.07-3.01; P = 0.027), and intervention group (OR, 1.74; 95% CI, 1.05-2.88; P = 0.031) were statistically significantly associated with acceptance of referral in multivariate analyses. CONCLUSIONS: Immediate feedback on referral status based on AI-supported screening was associated with statistically significantly higher referral adherence compared with delayed communications of results from human graders. These results provide evidence for an important benefit of AI screening in promoting adherence to prescribed treatment for diabetic eye care in sub-Saharan Africa.