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An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials

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 ar...

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Autores principales: Leow, Wei-Qiang, Bedossa, Pierre, Liu, Feng, Wei, Lai, Lim, Kiat-Hon, Wan, Wei-Keat, Ren, Yayun, Chang, Jason Pik-Eu, Tan, Chee-Kiat, Wee, Aileen, Goh, George Boon-Bee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7554942/
https://www.ncbi.nlm.nih.gov/pubmed/32872090
http://dx.doi.org/10.3390/diagnostics10090643
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author Leow, Wei-Qiang
Bedossa, Pierre
Liu, Feng
Wei, Lai
Lim, Kiat-Hon
Wan, Wei-Keat
Ren, Yayun
Chang, Jason Pik-Eu
Tan, Chee-Kiat
Wee, Aileen
Goh, George Boon-Bee
author_facet Leow, Wei-Qiang
Bedossa, Pierre
Liu, Feng
Wei, Lai
Lim, Kiat-Hon
Wan, Wei-Keat
Ren, Yayun
Chang, Jason Pik-Eu
Tan, Chee-Kiat
Wee, Aileen
Goh, George Boon-Bee
author_sort Leow, Wei-Qiang
collection PubMed
description 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.
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spelling pubmed-75549422020-10-14 An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials Leow, Wei-Qiang Bedossa, Pierre Liu, Feng Wei, Lai Lim, Kiat-Hon Wan, Wei-Keat Ren, Yayun Chang, Jason Pik-Eu Tan, Chee-Kiat Wee, Aileen Goh, George Boon-Bee Diagnostics (Basel) Article 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. MDPI 2020-08-28 /pmc/articles/PMC7554942/ /pubmed/32872090 http://dx.doi.org/10.3390/diagnostics10090643 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Leow, Wei-Qiang
Bedossa, Pierre
Liu, Feng
Wei, Lai
Lim, Kiat-Hon
Wan, Wei-Keat
Ren, Yayun
Chang, Jason Pik-Eu
Tan, Chee-Kiat
Wee, Aileen
Goh, George Boon-Bee
An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title_full An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title_fullStr An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title_full_unstemmed An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title_short An Improved qFibrosis Algorithm for Precise Screening and Enrollment into Non-Alcoholic Steatohepatitis (NASH) Clinical Trials
title_sort improved qfibrosis algorithm for precise screening and enrollment into non-alcoholic steatohepatitis (nash) clinical trials
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7554942/
https://www.ncbi.nlm.nih.gov/pubmed/32872090
http://dx.doi.org/10.3390/diagnostics10090643
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