Real-time diabetic retinopathy screening by deep learning in a multisite national screening programme: a prospective interventional cohort study

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Real-time diabetic retinopathy screening by deep learning in a multisite national screening programme: a prospective interventional cohort study


JournalThe Lancet Digital Health
Article typeJournal research article – Clinical research
Publication date – Mar – 2022
Authors – Paisan Ruamviboonsuk, Richa Tiwari, Rory Sayres, Variya Nganthavee, Kornwipa Hemarat, Apinpat Kongprayoon, Rajiv Raman, Brian Levinstein, Yun Liu, Mike Schaekermann, Roy Lee, Sunny Virmani, Kasumi Widner, John Chambers, Fred Hersch, Lily Peng, Dale R Webster
Keywordsdeep-learning system, diabetic retinopathy screenings, health-care system, LMICs, Thailand
Open access – Yes
SpecialityDigital health, Ophthalmology
World region South-eastern Asia
Country: Thailand
Language – English
Submitted to the One Surgery Index on March 15, 2022 at 9:25 am
Abstract:

Background
Diabetic retinopathy is a leading cause of preventable blindness, especially in low-income and middle-income countries (LMICs). Deep-learning systems have the potential to enhance diabetic retinopathy screenings in these settings, yet prospective studies assessing their usability and performance are scarce.

Methods
We did a prospective interventional cohort study to evaluate the real-world performance and feasibility of deploying a deep-learning system into the health-care system of Thailand. Patients with diabetes and listed on the national diabetes registry, aged 18 years or older, able to have their fundus photograph taken for at least one eye, and due for screening as per the Thai Ministry of Public Health guidelines were eligible for inclusion. Eligible patients were screened with the deep-learning system at nine primary care sites under Thailand’s national diabetic retinopathy screening programme. Patients with a previous diagnosis of diabetic macular oedema, severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy; previous laser treatment of the retina or retinal surgery; other non-diabetic retinopathy eye disease requiring referral to an ophthalmologist; or inability to have fundus photograph taken of both eyes for any reason were excluded. Deep-learning system-based interpretations of patient fundus images and referral recommendations were provided in real time. As a safety mechanism, regional retina specialists over-read each image. Performance of the deep-learning system (accuracy, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) were measured against an adjudicated reference standard, provided by fellowship-trained retina specialists. This study is registered with the Thai national clinical trials registry, TCRT20190902002.

Findings
Between Dec 12, 2018, and March 29, 2020, 7940 patients were screened for inclusion. 7651 (96·3%) patients were eligible for study analysis, and 2412 (31·5%) patients were referred for diabetic retinopathy, diabetic macular oedema, ungradable images, or low visual acuity. For vision-threatening diabetic retinopathy, the deep-learning system had an accuracy of 94·7% (95% CI 93·0–96·2), sensitivity of 91·4% (87·1–95·0), and specificity of 95·4% (94·1–96·7). The retina specialist over-readers had an accuracy of 93·5 (91·7–95·0; p=0·17), a sensitivity of 84·8% (79·4–90·0; p=0·024), and specificity of 95·5% (94·1–96·7; p=0·98). The PPV for the deep-learning system was 79·2 (95% CI 73·8–84·3) compared with 75·6 (69·8–81·1) for the over-readers. The NPV for the deep-learning system was 95·5 (92·8–97·9) compared with 92·4 (89·3–95·5) for the over-readers.

Interpretation
A deep-learning system can deliver real-time diabetic retinopathy detection capability similar to retina specialists in community-based screening settings. Socioenvironmental factors and workflows must be taken into consideration when implementing a deep-learning system within a large-scale screening programme in LMICs.

OSI Number – 21519

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