PathAI, Inc, Boston, MA, USA.
Department of Pathology, Yale University School of Medicine, New Haven, CT, USA.
J Pathol Clin Res. 2024 Sep;10(5):e12395. doi: 10.1002/2056-4538.12395.
The gold standard for enrollment and endpoint assessment in metabolic dysfunction-associated steatosis clinical trials is histologic assessment of a liver biopsy performed on glass slides. However, obtaining the evaluations from several expert pathologists on glass is challenging, as shipping the slides around the country or around the world is time-consuming and comes with the hazards of slide breakage. This study demonstrated that pathologic assessment of disease activity in steatohepatitis, performed using digital images on the AISight whole slide image management system, yields results that are comparable to those obtained using glass slides. The accuracy of scoring for steatohepatitis (nonalcoholic fatty liver disease activity score ≥4 with ≥1 for each feature and absence of atypical features suggestive of other liver disease) performed on the system was evaluated against scoring conducted on glass slides. Both methods were assessed for overall percent agreement with a consensus "ground truth" score (defined as the median score of a panel of three pathologists' glass slides). Each case was also read by three different pathologists, once on glass and once digitally with a minimum 2-week washout period between the modalities. It was demonstrated that the average agreement across three pathologists of digital scoring with ground truth was noninferior to the average agreement of glass scoring with ground truth [noninferiority margin: -0.05; difference: -0.001; 95% CI: (-0.027, 0.026); and p < 0.0001]. For each pathologist, there was a similar average agreement of digital and glass reads with glass ground truth (pathologist A, 0.843 and 0.849; pathologist B, 0.633 and 0.605; and pathologist C, 0.755 and 0.780). Here, we demonstrate that the accuracy of digital reads for steatohepatitis using digital images is equivalent to glass reads in the context of a clinical trial for scoring using the Clinical Research Network scoring system.
代谢功能障碍相关脂肪性肝病临床试验的登记和终点评估的金标准是对玻璃载玻片上进行的肝活检进行组织学评估。然而，让几位专家病理学家对玻璃片进行评估具有挑战性，因为在全国范围内或全球范围内运输载玻片既耗时又存在载玻片破损的风险。本研究表明，使用 AISight 全玻片图像管理系统上的数字图像对脂肪性肝炎进行的疾病活动病理评估可获得与使用玻璃载玻片获得的结果相当的结果。在系统上进行的脂肪性肝炎（非酒精性脂肪性肝病活动评分≥4，每个特征≥1，且无提示其他肝病的非典型特征）评分的准确性与在玻璃载玻片上进行的评分进行了评估。这两种方法均针对与共识“基准”评分（定义为三位病理学家玻璃载玻片评分的中位数）的总体百分比一致性进行了评估。每个病例还由三位不同的病理学家进行了两次读取，一次在玻璃上，一次在数字上，两次之间至少有 2 周的洗脱期。结果表明，三位病理学家的数字评分与基准的平均一致性不劣于玻璃评分与基准的平均一致性[非劣效性边界：-0.05；差异：-0.001；95%CI：（-0.027，0.026）；p<0.0001]。对于每位病理学家，数字和玻璃读取与玻璃基准的平均一致性相似（病理学家 A，0.843 和 0.849；病理学家 B，0.633 和 0.605；病理学家 C，0.755 和 0.780）。在这里，我们证明了在使用临床研究网络评分系统进行评分的临床试验背景下，使用数字图像进行脂肪性肝炎的数字读取的准确性与玻璃读取相当。
