Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score.

Biopsy Fibrosis Humans Liver / pathology Non-alcoholic Fatty Liver Disease / pathology Reproducibility of Results Severity of Illness Index

Journal

Hepatology (Baltimore, Md.)
ISSN: 1527-3350
Titre abrégé: Hepatology
Pays: United States
ID NLM: 8302946

Informations de publication

Date de publication:
10 2022
Historique:
revised: 11 03 2022
received: 22 12 2021
accepted: 14 03 2022
pubmed: 26 3 2022
medline: 23 9 2022
entrez: 25 3 2022
Statut: ppublish

Résumé

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). 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1002/hep.32475 PMID: 35332569 PMC: PMC9489601
pubmed: 35332569
doi: 10.1002/hep.32475
pmc: PMC9489601
mid: NIHMS1792684
doi:

Types de publication

Journal Article Research Support, N.I.H., Intramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

1150-1163

Subventions

Organisme : NIDDK NIH HHS
ID : U01 DK061734
Pays : United States

Informations de copyright

© 2022 American Association for the Study of Liver Diseases.

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Auteurs

Rish K Pai (RK)

Department of Laboratory Medicine & Pathology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.
ORCID: 0000-0002-2692-221X

Vipul Jairath (V)

Division of Gastroenterology, Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Alimentiv Inc., London, Ontario, Canada.
Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.

Malcolm Hogan (M)

Alimentiv Inc., London, Ontario, Canada.

Guangyong Zou (G)

Alimentiv Inc., London, Ontario, Canada.
Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.
Robarts Research Institute, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.

Oyedele A Adeyi (OA)

Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.

Quentin M Anstee (QM)

Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle Upon Tyne, UK.
NIHR Newcastle Biomedical Research Center, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
ORCID: 0000-0002-9518-0088

Bashar A Aqel (BA)

Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Phoenix, Arizona, USA.

Cynthia Behling (C)

Pacific Rim Pathology, San Diego, California, USA.
Department of Pediatrics, University of California San Diego, La Jolla, California, USA.

Elizabeth J Carey (EJ)

Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Phoenix, Arizona, USA.

Andrew D Clouston (AD)

Faculty of Medicine and Biomedical Sciences, University of Queensland, Brisbane, Queensland, Australia.

Kathleen Corey (K)

Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Harvard Medical School, Boston, Massachusetts, USA.
ORCID: 0000-0003-2882-7264

Brian G Feagan (BG)

Division of Gastroenterology, Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Alimentiv Inc., London, Ontario, Canada.
Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.

David E Kleiner (DE)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.

Christopher Ma (C)

Alimentiv Inc., London, Ontario, Canada.
Division of Gastroenterology & Hepatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
ORCID: 0000-0002-4698-9948

Stefanie C McFarlane (SC)

Alimentiv Inc., London, Ontario, Canada.

Mazen Noureddin (M)

Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.

Vlad Ratziu (V)

Institute of Cardiometabolism and Nutrition, Sorbonne Université, Pitié-Salpêtrière Hospital, Paris, France.
ORCID: 0000-0002-3051-0111

Mark A Valasek (MA)

Department of Pathology, University of California at San Diego, La Jolla, California, USA.

Zobair M Younossi (ZM)

Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia, USA.
Department of Medicine, Center for Liver Diseases, Inova Fairfax Medical Campus, Falls Church, Virginia, USA.
ORCID: 0000-0001-9313-577X

Stephen A Harrison (SA)

Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Medical Director, Pinnacle Clinical Research, San Antonio, Texas, USA.

Rohit Loomba (R)

NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California at San Diego, La Jolla, California, USA.
ORCID: 0000-0002-4845-9991

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytodiagnostic › Biopsie › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Fibrose › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › Système digestif › Foie › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › Maladies de l'appareil digestif › Maladies du foie › Stéatose hépatique › Stéatose hépatique non alcoolique › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › Reliability of histologic assessment for NAFLD...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes de santé › Indicateurs d'état de santé › Acuité des besoins du patient › Indice de gravité de la maladie › Reliability of histologic assessment for NAFLD...