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Lookup NU author(s): Professor Quentin AnsteeORCiD
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© 2022 American Association for the Study of Liver Diseases. Background and Aims: The NASH Clinical Research Network histologic scoring system, the gold-standard NASH histology assessment for clinical trials, has demonstrated intrarater and interrater variability. An expert panel in a previous systematic Research and Development/University of California Los Angeles (RAND/UCLA) study determined that existing histologic scoring systems do not fully capture NASH disease activity and fibrosis, and standardized definitions of histologic features are needed. We evaluated the reliability of existing and alternate histologic measures and their correlations with a disease activity visual analog scale to propose optimal components for an expanded NAFLD activity score (NAS). Approach and Results: Four liver pathologists who were involved in the prior RAND/UCLA study underwent standardized training and multiple discussions with the goal of improving agreement. They were blinded to clinical information and scored histologic measures twice, ≥2 weeks apart, for 40 liver biopsies representing the full spectrum of NAFLD. Index intraclass correlation coefficient (ICC) estimates demonstrated intrarater (0.80–0.85) and interrater (0.60–0.72) reliability. Hepatocyte ballooning items had similar interrater ICCs (0.68–0.79), including those extending scores from 0–2 to 0–4. Steatosis measures (interrater ICCs, 0.72–0.80) correlated poorly with disease activity. Correlations with disease activity were largest for hepatocyte ballooning and Mallory-Denk bodies (MDBs), with both used to develop the expanded NAS (intrarater ICC, 0.90; interrater ICC, 0.80). Fibrosis measures had ICCs of 0.70–0.87. Conclusions: After extensive preparation among a group of experienced pathologists, we demonstrated improved reliability of multiple existing histologic NAFLD indices and fibrosis staging systems. Hepatocyte ballooning and MDBs most strongly correlated with disease activity and were used for the expanded NAS. Further validation including evaluation of responsiveness is required.
Author(s): Pai RK, Jairath V, Hogan M, Zou G, Adeyi OA, Anstee QM, Aqel BA, Behling C, Carey EJ, Clouston AD, Corey K, Feagan BG, Kleiner DE, Ma C, McFarlane SC, Noureddin M, Ratziu V, Valasek MA, Younossi ZM, Harrison SA, Loomba R
Publication type: Article
Publication status: Published
Journal: Hepatology
Year: 2022
Volume: 76
Issue: 4
Pages: 1150-1163
Print publication date: 01/10/2022
Online publication date: 06/04/2022
Acceptance date: 14/03/2022
ISSN (print): 0270-9139
ISSN (electronic): 1527-3350
Publisher: John Wiley and Sons Inc
URL: https://doi.org/10.1002/hep.32475
DOI: 10.1002/hep.32475
PubMed id: 35332569
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