Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices
| Autor: | Philip T. Lavin, James C. Folk, Michele Birch, Nilay Shah, Michael D. Abràmoff |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Pediatrics
medicine.medical_specialty Diabetic macular edema Medicine (miscellaneous) Health Informatics Primary care Fundus (eye) lcsh:Computer applications to medicine. Medical informatics Diagnostic system Article 03 medical and health sciences 0302 clinical medicine Health Information Management Diabetes mellitus Health care medicine 030212 general & internal medicine Eye manifestations Intensive care medicine business.industry Diabetic retinopathy medicine.disease eye diseases Computer Science Applications 030221 ophthalmology & optometry lcsh:R858-859.7 Transmission system operator business Biomedical engineering |
| Zdroj: | npj Digital Medicine, Vol 1, Iss 1, Pp 1-8 (2018) NPJ Digital Medicine |
| ISSN: | 2398-6352 |
| DOI: | 10.1038/s41746-018-0040-6 |
| Popis: | Artificial Intelligence (AI) has long promised to increase healthcare affordability, quality and accessibility but FDA, until recently, had never authorized an autonomous AI diagnostic system. This pivotal trial of an AI system to detect diabetic retinopathy (DR) in people with diabetes enrolled 900 subjects, with no history of DR at primary care clinics, by comparing to Wisconsin Fundus Photograph Reading Center (FPRC) widefield stereoscopic photography and macular Optical Coherence Tomography (OCT), by FPRC certified photographers, and FPRC grading of Early Treatment Diabetic Retinopathy Study Severity Scale (ETDRS) and Diabetic Macular Edema (DME). More than mild DR (mtmDR) was defined as ETDRS level 35 or higher, and/or DME, in at least one eye. AI system operators underwent a standardized training protocol before study start. Median age was 59 years (range, 22–84 years); among participants, 47.5% of participants were male; 16.1% were Hispanic, 83.3% not Hispanic; 28.6% African American and 63.4% were not; 198 (23.8%) had mtmDR. The AI system exceeded all pre-specified superiority endpoints at sensitivity of 87.2% (95% CI, 81.8–91.2%) (>85%), specificity of 90.7% (95% CI, 88.3–92.7%) (>82.5%), and imageability rate of 96.1% (95% CI, 94.6–97.3%), demonstrating AI’s ability to bring specialty-level diagnostics to primary care settings. Based on these results, FDA authorized the system for use by health care providers to detect more than mild DR and diabetic macular edema, making it, the first FDA authorized autonomous AI diagnostic system in any field of medicine, with the potential to help prevent vision loss in thousands of people with diabetes annually. ClinicalTrials.gov NCT02963441 |
| Databáze: | OpenAIRE |
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