Diabetes complications

Performance of a Deep Learning Diabetic Retinopathy Algorithm in India

JAMA Netw OpenPublished Diagnostic accuracy study

An erratum to this article was published (JAMA Netw Open, 1 Apr 2025 ↗)

Authors' conclusion

In this cross-sectional study investigating the clinical performance of ARDA, sensitivity and specificity for severe NPDR and PDR exceeded 96% and caught 100% of patients with severe NPDR and PDR for ophthalmology referral. This preliminary large-scale postmarketing report of the performance of ARDA after screening 600 000 patients in India underscores the importance of monitoring and publication an algorithm's clinical performance, consistent with recommendations by regulatory bodies.

Study context

Population
Patients screened using automated retinal disease assessment (ARDA) at Aravind Eye Hospital, 45 sites in Southern India, randomly selected January 1, 2019–July 31, 2023; mean (SD) age 55.2 (11.9) years, 50.1% male3,941 with gradable photographs
Participants
4,537 patients
Comparison
ARDA vs adjudicated grades by US ophthalmologists
Outcome
Sensitivity and specificity of ARDA for severe NPDR or PDR
Methodological detailscross-sectional, postdeployment, multicentre (45 sites)
  • Cross-sectional
  • Postdeployment
  • Multicentre (45 sites)

Performance

As reported in the abstract

Severe NPDR or PDR
Test or modelSensitivitySpecificityPPVNPVClinically important miss rate
ARDA97.0% (95% CI, 92.6%-99.2%)96.4% (95% CI, 95.7%-97.0%)50.7%99.9%0%

ARDA

Sensitivity97.0% (95% CI, 92.6%-99.2%)
Specificity96.4% (95% CI, 95.7%-97.0%)
PPV50.7%
NPV99.9%
Clinically important miss rate0%

Further findings

OutcomeARDA
STDR (DME or severe NPDR or PDR)
Sensitivity95.9% (95% CI, 93.0%-97.4%)
Specificity94.9% (95% CI, 94.1%-95.7%)
PPV67.9%
NPV99.5%

Prevalence among patients with gradable photographs

Any DR
683 (17.3%)
Severe nonproliferative DR (NPDR) or proliferative DR (PDR)
146 (3.7%)
PDR
109 (2.8%)
Sight-threatening DR (STDR)
398 (10.1%)

Original publication

Performance of a Deep Learning Diabetic Retinopathy Algorithm in India. JAMA Netw Open. Published 3 March 2025. doi:10.1001/jamanetworkopen.2025.0984

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