{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,30]],"date-time":"2026-08-30T02:39:37Z","timestamp":1788057577771,"version":"build-2784847793"},"reference-count":37,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T00:00:00Z","timestamp":1726617600000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["pathsocjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Pathology CR"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The gold standard for enrollment and endpoint assessment in metabolic dysfunction\u2010associated 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\u2010consuming 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 \u22654 with \u22651 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 \u201cground truth\u201d score (defined as the median score of a panel of three pathologists\u2019 glass slides). Each case was also read by three different pathologists, once on glass and once digitally with a minimum 2\u2010week 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: \u22120.05; difference: \u22120.001; 95% CI: (\u22120.027, 0.026); and <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001]. 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.<\/jats:p>","DOI":"10.1002\/2056-4538.12395","type":"journal-article","created":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:40:24Z","timestamp":1726706424000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Validation of a whole slide image management system for metabolic\u2010associated steatohepatitis for clinical trials"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8092-0066","authenticated-orcid":false,"given":"Hanna","family":"Pulaski","sequence":"first","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shraddha S","family":"Mehta","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laryssa C","family":"Manigat","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Kaufman","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hypatia","family":"Hou","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"ILKe","family":"Nalbantoglu","sequence":"additional","affiliation":[{"name":"Department of Pathology Yale University School of Medicine  New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuchen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Pathology Yale University School of Medicine  New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Curl","sequence":"additional","affiliation":[{"name":"Foundation Medicine, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross","family":"Taliano","sequence":"additional","affiliation":[{"name":"Department of Pathology Rhode Island Hospital  Providence RI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Hun","family":"Kim","sequence":"additional","affiliation":[{"name":"Pathology Medical Group of Riverside  Providence RI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Torbenson","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology Mayo Clinic  Rochester MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan N","family":"Glickman","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray B","family":"Resnick","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neel","family":"Patel","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristin E","family":"Taylor","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Bedossa","sequence":"additional","affiliation":[{"name":"Liverpat and University of Paris  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael C","family":"Montalto","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew H","family":"Beck","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7761-3637","authenticated-orcid":false,"given":"Katy E","family":"Wack","sequence":"additional","affiliation":[{"name":"PathAI, Inc  Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28431"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41395-018-0088-6"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-018-0104-9"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.20701"},{"key":"e_1_2_8_6_1","unstructured":"European Medicines Agency.Reflection Paper on Regulatory Requirements for the Development of Medicinal Products for Non\u2010Alcoholic Steatohepatitis (NASH) (EMA\/CHMP\/111529\/2024). 2023. 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