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Title: An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
Authors: Leow, W.-Q.
Bedossa, P.
Liu, F.
Wei, L.
Lim, K.-H. 
Wan, W.-K.
Ren, Y.
Chang, J.P.-E. 
Tan, C.-K. 
Wee, A. 
Goh, G.B.-B. 
Keywords: NAFLD
NASH fibrosis
Issue Date: 2020
Publisher: MDPI AG
Citation: Leow, W.-Q., Bedossa, P., Liu, F., Wei, L., Lim, K.-H., Wan, W.-K., Ren, Y., Chang, J.P.-E., Tan, C.-K., Wee, A., Goh, G.B.-B. (2020). An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials. Diagnostics 10 (9) : 643. ScholarBank@NUS Repository.
Rights: Attribution 4.0 International
Abstract: Background: Many clinical trials with potential drug treatment options for non-alcoholic fatty liver disease (NAFLD) are focused on patients with non-alcoholic steatohepatitis (NASH) stages 2 and 3 fibrosis. As the histological features differentiating stage 1 (F1) from stage 2 (F2) NASH fibrosis are subtle, some patients may be wrongly staged by the in-house pathologist and miss the opportunity for enrollment into clinical trials. We hypothesized that our refined artificial intelligence (AI)-based algorithm (qFibrosis) can identify these subtle differences and serve as an assistive tool for in-house pathologists. Methods: Liver tissue from 160 adult patients with biopsy-proven NASH from Singapore General Hospital (SGH) and Peking University People’s Hospital (PKUH) were used. A consensus read by two expert hepatopathologists was organized. The refined qFibrosis algorithm incorporated the creation of a periportal region that allowed for the increased detection of periportal fibrosis. Consequently, an additional 28 periportal parameters were added, and 28 pre-existing perisinusoidal parameters had altered definitions. Results: Twenty-eight parameters (20 periportal and 8 perisinusoidal) were significantly different between the F1 and F2 cases that prompted a change of stage after a careful consensus read. The discriminatory ability of these parameters was further demonstrated in a comparison between the true F1 and true F2 cases as 26 out of the 28 parameters showed significant differences. These 26 parameters constitute a novel sub-algorithm that could accurately stratify F1 and F2 cases. Conclusion: The refined qFibrosis algorithm incorporated 26 novel parameters that showed a good discriminatory ability for NASH fibrosis stage 1 and 2 cases, representing an invaluable assistive tool for in-house pathologists when screening patients for NASH clinical trials. © 2020 by the authors.
Source Title: Diagnostics
ISSN: 20754418
DOI: 10.3390/diagnostics10090643
Rights: Attribution 4.0 International
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