新西兰筛查项目中THEIA检测糖尿病视网膜病变（DR）和糖尿病黄斑水肿（DME）的多中心前瞻性评价
A multi-center prospective evaluation of THEIA to detect diabetic retinopathy (DR) and diabetic macular edema (DME) in the New Zealand screening program
摘要：
目的：在一项多中心前瞻性研究中评估人工智能THEIA筛查糖尿病视网膜病变的有效性。验证THEIA在国家筛查项目中作为临床决策辅助的潜在应用。研究方法：从城市大型眼科医院或半农村验光师领导的筛查提供商招募了902名患者，因为他们参加了作为新西兰糖尿病筛查计划一部分的预约。这些诊所使用各种视网膜摄像机和一系列操作员。然后由三位高级视网膜专家对去识别图像进行独立分级，并使用新西兰分级方案汇总最终结果，然后将其转换为可识别的\non -可识别的和健康的\mild \more，而不是轻度\vision威胁类别。结果：与地面实况相比，THEIA达到100%的敏感性和[95.35%-97.44%]特异性，阴性预测值为100%。THEIA也没有错过任何超过轻度或视力威胁疾病的患者。临床医生与汇总结果之间的一致性水平为（k值：0.9881、0.9557和0.9175），THEIA与汇总标签之间的一致性水平为（k值：0.9515）。结论：我们的多中心前瞻性试验表明，THEIA在筛查糖尿病视网膜病变和黄斑病变时不会遗漏可诊断的疾病。它在报告疾病水平方面也具有非常高的粒度水平。由于THEIA正在各种相机上进行测试，在一系列诊所（农村\urban，眼科医生领导的\optometrist领导）中运行，我们相信它将是公共糖尿病筛查计划的合适补充。
英文摘要：
Purpose: to assess the efficacy of THEIA, an artificial intelligence for screening diabetic retinopathy in a multi-center prospective study. To validate the potential application of THEIA as clinical decision making assistant in a national screening program. Methods: 902 patients were recruited from either an urban large eye hospital, or a semi-rural optometrist led screening provider, as they were attending their appointment as part of New Zealand Diabetic Screening programme. These clinics used a variety of retinal cameras and a range of operators. The de-identified images were then graded independently by three senior retinal specialists, and final results were aggregated using New Zealand grading scheme, which is then converted to referable\non-referable and Healthy\mild\more than mild\vision threatening categories. Results: compared to ground truth, THEIA achieved 100% sensitivity and [95.35%-97.44%] specificity, and negative predictive value of 100%. THEIA also did not miss any patients with more than mild or vision threatening disease. The level of agreement between the clinicians and the aggregated results was (k value: 0.9881, 0.9557, and 0.9175), and the level of agreement between THEIA and the aggregated labels was (k value: 0.9515). Conclusion: Our multi-centre prospective trial showed that THEIA does not miss referable disease when screening for diabetic retinopathy and maculopathy. It also has a very high level of granularity in reporting the disease level. Since THEIA is being tested on a variety of cameras, operating in a range of clinics (rural\urban, ophthalmologist-led\optometrist-led), we believe that it will be a suitable addition to a public diabetic screening program.
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