Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices
Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices
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DOI：
10.1038/s41746-018-0040-6
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发表时间：
2018-08-28
影响因子：
15.2
通讯作者：
Folk, James C.
中科院分区：
文献类型：
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作者：
Abramoff, Michael D.;Lavin, Philip T.;Folk, James C.
人工智能 (AI) 长期以来一直承诺提高医疗保健的可负担性、质量和可及性，但 FDA 直到最近才批准自主人工智能诊断系统。这项人工智能系统检测糖尿病患者糖尿病视网膜病变 (DR) 的关键试验招募了 900 名在初级保健诊所没有 DR 病史的受试者，通过与威斯康星眼底照片阅读中心 (FPRC) 宽视场立体摄影和黄斑光学相干断层扫描 (OCT)（由 FPRC 认证摄影师进行）以及 FPRC 对早期治疗糖尿病视网膜病变研究严重程度量表 (ETDRS) 和糖尿病黄斑的分级进行比较水肿（DME）。超过轻度 DR (mtmDR) 被定义为至少一只眼睛的 ETDRS 水平 35 或更高，和/或 DME。人工智能系统操作员在研究开始前接受了标准化培训协议。中位年龄为 59 岁（范围：22-84 岁）；在参与者中，47.5%的参与者是男性； 16.1% 为西班牙裔，83.3% 为非西班牙裔； 28.6% 为非洲裔美国人，63.4% 为非裔美国人； 198 人 (23.8%) 患有 mtmDR。 AI 系统超出了所有预先指定的优越性终点，敏感性为 87.2%（95% CI，81.8-91.2%）（> 85%），特异性为 90.7%（95% CI，88.3-92.7%）（> 82.5%），成像率为 96.1%（95% CI，94.6-97.3%），证明了人工智能能够将专业级诊断引入初级保健机构。基于这些结果，FDA 授权医疗保健提供者使用该系统来检测轻度 DR 和糖尿病性黄斑水肿，使其成为 FDA 在任何医学领域授权的第一个自主人工智能诊断系统，每年有可能帮助数千名糖尿病患者预防视力丧失。
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.