Cited by 194Retinal Imaging and AnalysisRetinal Diseases and TreatmentsArtificial Intelligence in Healthcare and Education

Multicenter, Head-to-Head, Real-World Validation Study of Seven Automated Artificial Intelligence Diabetic Retinopathy Screening Systems

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Lee, Aaron Y., Yanagihara, Ryan T., Lee, Cecilia S., Blazes, Marian, Jung, Hoon C., Chee, Yewlin E., Gencarella, Michael D., Gee, Harry +4 more·2021·Diabetes Care

Abstract

OBJECTIVE: With rising global prevalence of diabetic retinopathy (DR), automated DR screening is needed for primary care settings. Two automated artificial intelligence (AI)–based DR screening algorithms have U.S. Food and Drug Administration (FDA) approval. Several others are under consideration while in clinical use in other countries, but their real-world performance has not been evaluated systematically. We compared the performance of seven automated AI-based DR screening algorithms (including one FDA-approved algorithm) against human graders when analyzing real-world retinal imaging data. RESEARCH DESIGN AND METHODS: This was a multicenter, noninterventional device validation study evaluating a total of 311,604 retinal images from 23,724 veterans who presented for teleretinal DR screening at the Veterans Affairs (VA) Puget Sound Health Care System (HCS) or Atlanta VA HCS from 2006 to 2018. Five companies provided seven algorithms, including one with FDA approval, that independently analyzed all scans, regardless of image quality. The sensitivity/specificity of each algorithm when classifying images as referable DR or not were compared with original VA teleretinal grades and a regraded arbitrated data set. Value per encounter was estimated. RESULTS: Although high negative predictive values (82.72–93.69%) were observed, sensitivities varied widely (50.98–85.90%). Most algorithms performed no better than humans against the arbitrated data set, but two achieved higher sensitivities, and one yielded comparable sensitivity (80.47%, P = 0.441) and specificity (81.28%, P = 0.195). Notably, one had lower sensitivity (74.42%) for proliferative DR (P = 9.77 × 10−4) than the VA teleretinal graders. Value per encounter varied at $15.14–$18.06 for ophthalmologists and $7.74–$9.24 for optometrists. CONCLUSIONS: The DR screening algorithms showed significant performance differences. These results argue for rigorous testing of all such algorithms on real-world data before clinical implementation.

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  • Autonomous point-of-care, centralized AI or teleophthalmology, and hybrid AI-plus-human grading models cannot be universally ranked because each offers a different balance of immediacy, specialist oversight, infrastructure requirements, and workflow complexity.

    “Autonomous point-of-care, centralized AI or teleophthalmology, and hybrid AI-plus-human grading models should not be ranked universally, because each offers a different balance of immediacy, specialist oversight, infrastructure requirements, and workflow complexity.”

    From From validation to public health impact: implementing equitable AI-enabled diabetic retinopathy screening (2026) · cites this paper as [10]

    The Conclusions discuss AI as a first screening step with ophthalmologists reviewing flagged cases, and note integration, hardware, and cloud-service considerations for the VA teleretinal system (page not provided). They do not compare autonomous point-of-care, centralized, and hybrid models or conclude that those models should not be ranked universally on the stated criteria. (LLM, conf=0.83)

    Experimental — accuracy not yet measured
  • Autonomous AI systems can provide same-visit results and reduce dependence on asynchronous grading; centralized AI/teleophthalmology models can support multisite quality assurance and specialist oversight; hybrid AI-plus-human models retain human review for selected or uncertain cases.

    “Autonomous systems can provide same-visit results and reduce dependence on asynchronous grading, whereas centralized models may support multisite quality assurance and specialist oversight; hybrid models retain human review for selected or uncertain cases (8,10,11,14,17,21).”

    From From validation to public health impact: implementing equitable AI-enabled diabetic retinopathy screening (2026) · cites this paper as [10]

    Split into 3 atoms — 1 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured
  • AI-enabled screening can reproduce or worsen inequity if devices are unavailable, internet connectivity is weak, staff are inadequately trained, costs are shifted to patients, or algorithms perform differently across populations and camera systems.

    “However, the same technology can reproduce or worsen inequity if devices are unavailable, internet connectivity is weak, staff are inadequately trained, costs are shifted to patients, or algorithms perform differently across populations and camera systems (10,(31)(32)(33).”

    From From validation to public health impact: implementing equitable AI-enabled diabetic retinopathy screening (2026) · cites this paper as [10]

    The Conclusions report performance differences between sites and warn that algorithms may not generalize across populations; they also link image quality to technician training. The Methods identify camera-system specifications as part of the acquisition protocol. The paper does not establish that unavailable devices, weak internet connectivity, or costs shifted to patients worsen inequity; its systems were tested without an internet connection. (LLM, conf=0.87)

    Experimental — accuracy not yet measured
  • Independent head-to-head validation has shown that performance can vary materially across algorithms even when systems are applied to the same real-world data.

    “Independent head-to-head validation has shown that performance can vary materially across algorithms even when systems are applied to the same real-world data (10).”

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Cited by

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Authors
Lee, A. Y., Yanagihara, R. T., Lee, C. S., Blazes, M., Jung, H. C., Chee, Y. E., Gencarella, M. D., Gee, H., Maa, A. Y., Cockerham, G. C., Lynch, M., & Boyko, E. J.
Affiliations
  • University of Washington (US)
  • Office of Information and Technology, Clinical Imaging, Seattle, WA
  • Emory University (US)
  • Veterans Health Administration (US)
  • United States Department of Veterans Affairs (US)
Corresponding author
Lee, Aaron Y.
Venue
Diabetes Care
Published
2021-01-05
Volume
44
Issue
5
Pages
1168-1175
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
OpenAlex
W3119783096
Cited by
194
References
32
Citations by year
2026: 41 · 2025: 40 · 2024: 28 · 2023: 40 · 2022: 22 · 2021: 21 · 2020: 2
FWCI
14.66
Type
journal article
Language
en
Open access
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Eye Institute (K23-EY-029246, R01-AG-060942)
  • Research to Prevent Blindness
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal Imaging and Analysis
  • Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
Keywords
diabetic retinopathy, automated screening, artificial intelligence, retinal image analysis, algorithm comparison, referable diabetic retinopathy, proliferative diabetic retinopathy, sensitivity and specificity, primary care screening, veterans
MeSH terms
Algorithms, Artificial Intelligence, Diabetes Mellitus, Diabetic Retinopathy, Humans, Mass Screening, Sensitivity and Specificity

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