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Prospective evaluation of an artificial intelligence-enabled algorithm for automated diabetic retinopathy screening of 30 000 patients

Prospective evaluation of an artificial intelligence-enabled algorithm for automated diabetic retinopathy screening of 30 000 patients
Prospective evaluation of an artificial intelligence-enabled algorithm for automated diabetic retinopathy screening of 30 000 patients
Background/aims: human grading of digital images from diabetic retinopathy (DR) screening programmes represents a significant challenge, due to the increasing prevalence of diabetes. We evaluate the performance of an automated artificial intelligence (AI) algorithm to triage retinal images from the English Diabetic Eye Screening Programme (DESP) into test-positive/technical failure versus test-negative, using human grading following a standard national protocol as the reference standard.

Methods: retinal images from 30 405 consecutive screening episodes from three English DESPs were manually graded following a standard national protocol and by an automated process with machine learning enabled software, EyeArt v2.1. Screening performance (sensitivity, specificity) and diagnostic accuracy (95% CIs) were determined using human grades as the reference standard.

Results: sensitivity (95% CIs) of EyeArt was 95.7% (94.8% to 96.5%) for referable retinopathy (human graded ungradable, referable maculopathy, moderate-to-severe non-proliferative or proliferative). This comprises sensitivities of 98.3% (97.3% to 98.9%) for mild-to-moderate non-proliferative retinopathy with referable maculopathy, 100% (98.7%,100%) for moderate-to-severe non-proliferative retinopathy and 100% (97.9%,100%) for proliferative disease. EyeArt agreed with the human grade of no retinopathy (specificity) in 68% (67% to 69%), with a specificity of 54.0% (53.4% to 54.5%) when combined with non-referable retinopathy.

Conclusion: the algorithm demonstrated safe levels of sensitivity for high-risk retinopathy in a real-world screening service, with specificity that could halve the workload for human graders. AI machine learning and deep learning algorithms such as this can provide clinically equivalent, rapid detection of retinopathy, particularly in settings where a trained workforce is unavailable or where large-scale and rapid results are needed.
Clinical Trial, Degeneration, Diagnostic tests/Investigation, Epidemiology, Imaging, Medical Education, Public health, Retina, Telemedicine, Treatment Medical
0007-1161
723-728
Heydon, Peter
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Egan, Catherine
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Bolter, Louis
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Chambers, Ryan
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Anderson, John
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Aldington, Steve
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Stratton, Irene M.
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Scanlon, Peter Henry
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Webster, Laura
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Mann, Samantha
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Du Chemin, Alain
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Owen, Christopher G.
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Tufail, Adnan
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Rudnicka, Alicja Regina
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Heydon, Peter
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Egan, Catherine
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Bolter, Louis
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Chambers, Ryan
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Anderson, John
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Aldington, Steve
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Stratton, Irene M.
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Scanlon, Peter Henry
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Webster, Laura
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Mann, Samantha
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Du Chemin, Alain
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Owen, Christopher G.
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Tufail, Adnan
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Rudnicka, Alicja Regina
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Heydon, Peter, Egan, Catherine, Bolter, Louis, Chambers, Ryan, Anderson, John, Aldington, Steve, Stratton, Irene M., Scanlon, Peter Henry, Webster, Laura, Mann, Samantha, Du Chemin, Alain, Owen, Christopher G., Tufail, Adnan and Rudnicka, Alicja Regina (2021) Prospective evaluation of an artificial intelligence-enabled algorithm for automated diabetic retinopathy screening of 30 000 patients. British Journal of Ophthalmology, 105 (5), 723-728. (doi:10.1136/bjophthalmol-2020-316594).

Record type: Review

Abstract

Background/aims: human grading of digital images from diabetic retinopathy (DR) screening programmes represents a significant challenge, due to the increasing prevalence of diabetes. We evaluate the performance of an automated artificial intelligence (AI) algorithm to triage retinal images from the English Diabetic Eye Screening Programme (DESP) into test-positive/technical failure versus test-negative, using human grading following a standard national protocol as the reference standard.

Methods: retinal images from 30 405 consecutive screening episodes from three English DESPs were manually graded following a standard national protocol and by an automated process with machine learning enabled software, EyeArt v2.1. Screening performance (sensitivity, specificity) and diagnostic accuracy (95% CIs) were determined using human grades as the reference standard.

Results: sensitivity (95% CIs) of EyeArt was 95.7% (94.8% to 96.5%) for referable retinopathy (human graded ungradable, referable maculopathy, moderate-to-severe non-proliferative or proliferative). This comprises sensitivities of 98.3% (97.3% to 98.9%) for mild-to-moderate non-proliferative retinopathy with referable maculopathy, 100% (98.7%,100%) for moderate-to-severe non-proliferative retinopathy and 100% (97.9%,100%) for proliferative disease. EyeArt agreed with the human grade of no retinopathy (specificity) in 68% (67% to 69%), with a specificity of 54.0% (53.4% to 54.5%) when combined with non-referable retinopathy.

Conclusion: the algorithm demonstrated safe levels of sensitivity for high-risk retinopathy in a real-world screening service, with specificity that could halve the workload for human graders. AI machine learning and deep learning algorithms such as this can provide clinically equivalent, rapid detection of retinopathy, particularly in settings where a trained workforce is unavailable or where large-scale and rapid results are needed.

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Accepted/In Press date: 28 May 2020
e-pub ahead of print date: 30 June 2020
Published date: 1 May 2021
Additional Information: Funding Information: Funding This research has received a proportion of its funding from the Department of Health’s NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology. The views expressed in the publication are those of the authors and not necessarily those of the Department of Health. Diabetes prevention research at St George’s, University of London, is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) (grant reference NIHR200152).
Keywords: Clinical Trial, Degeneration, Diagnostic tests/Investigation, Epidemiology, Imaging, Medical Education, Public health, Retina, Telemedicine, Treatment Medical

Identifiers

Local EPrints ID: 487209
URI: http://eprints.soton.ac.uk/id/eprint/487209
ISSN: 0007-1161
PURE UUID: 4ae3296c-0abf-43ea-aa7f-1258554a8f90
ORCID for Irene M. Stratton: ORCID iD orcid.org/0000-0003-1172-7865

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Date deposited: 16 Feb 2024 10:31
Last modified: 18 Mar 2024 04:01

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Contributors

Author: Peter Heydon
Author: Catherine Egan
Author: Louis Bolter
Author: Ryan Chambers
Author: John Anderson
Author: Steve Aldington
Author: Irene M. Stratton ORCID iD
Author: Peter Henry Scanlon
Author: Laura Webster
Author: Samantha Mann
Author: Alain Du Chemin
Author: Christopher G. Owen
Author: Adnan Tufail
Author: Alicja Regina Rudnicka

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