Validation of a whole slide image management system for metabolic‐associated steatohepatitis for clinical trials

Autor: Hanna Pulaski, Shraddha S Mehta, Laryssa C Manigat, Stephanie Kaufman, Hypatia Hou, ILKe Nalbantoglu, Xuchen Zhang, Emily Curl, Ross Taliano, Tae Hun Kim, Michael Torbenson, Jonathan N Glickman, Murray B Resnick, Neel Patel, Cristin E Taylor, Pierre Bedossa, Michael C Montalto, Andrew H Beck, Katy E Wack
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: The Journal of Pathology: Clinical Research, Vol 10, Iss 5, Pp n/a-n/a (2024)
Druh dokumentu: article
ISSN: 2056-4538
DOI: 10.1002/2056-4538.12395
Popis: Abstract 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
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