PDF(Pubmed)
Abstract：
Advances in whole-slide imaging and artificial intelligence present opportunities for improvement in Pap test screening. To date, there have been limited studies published regarding how best to validate newer AI-based digital systems for screening Pap tests in clinical practice. In this study, we validated the Genius™ Digital Diagnostics System (Hologic) by comparing the performance to traditional manual light microscopic diagnosis of ThinPrep® Pap test slides. A total of 319 ThinPrep® Pap test cases were prospectively assessed by six cytologists and three cytopathologists by light microscopy and digital evaluation and the results compared to the original ground truth Pap test diagnosis. Concordance with the original diagnosis was significantly different by digital and manual light microscopy review when comparing across: (i) exact Bethesda System diagnostic categories (62.1% vs 55.8%, respectively, p = 0.014), (ii) condensed diagnostic categories (76.8% vs 71.5%, respectively, p = 0.027), and (iii) condensed diagnoses based on clinical management (71.5% vs 65.2%, respectively, p = 0.017). Time to evaluate cases was shorter for digital (M = 3.2 min, SD = 2.2) compared to manual (M = 5.9 min, SD = 3.1) review (t(352) = 19.44, p < 0.001, Cohen\'s d = 1.035, 95% CI [0.905, 1.164]). Not only did our validation study demonstrate that AI-based digital Pap test evaluation had improved diagnostic accuracy and reduced screening time compared to light microscopy, but that participants reported a positive experience using this system.
摘要：
全载玻片成像和人工智能的进步为改善巴氏试验筛查提供了机会。迄今为止,关于如何在临床实践中最好地验证新的基于AI的数字系统来筛查Pap测试的研究有限.在这项研究中,我们通过将ThinPrep®Pap试片的性能与传统手动光学显微镜诊断的性能进行比较,验证了Genius™数字诊断系统(Hologic).6位细胞学家和3位细胞病理学家通过光学显微镜和数字评估对总共319例ThinPrep®Pap测试病例进行了前瞻性评估，并将结果与原始真实Pap测试诊断进行了比较。通过数字和手动光学显微镜检查比较，与原始诊断的一致性显着不同：（i）确切的贝塞斯达系统诊断类别（62.1％vs55.8％，分别,p=0.014),(ii)浓缩诊断类别(76.8%vs71.5%，分别,p=0.027),和（iii）基于临床管理的浓缩诊断（71.5%vs65.2%，分别,p=0.017)。数字评估病例的时间较短(M=3.2分钟，SD=2.2)与手动(M=5.9分钟，SD=3.1)综述(t(352)=19.44，p<0.001，科恩d=1.035，95%CI[0.905，1.164])。我们的验证研究不仅表明，与光学显微镜相比，基于AI的数字Pap测试评估提高了诊断准确性并减少了筛查时间，但参与者报告了使用这个系统的积极经验。
