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Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis

Mózes FE 1 , Lee JA 2 , Vali Y 2 , Selvaraj EA 1 , Jayaswal ANA 1 , Boursier J 3 Show all authors , de Lédinghen V 4 , Lupșor-Platon M 5 , Yilmaz Y 6 , Chan WK 7 , Mahadeva S 7 , Karlas T 8 , Wiegand J 8 , Shalimar 9 , Tsochatzis E 10 , Liguori A 10 , Wong VW 11 , Lee DH 12 , Holleboom AG 13 , van Dijk AM 13 , Mak AL 13 , Hagström H 14 , Akbari C 15 , Hirooka M 16 , Lee DH 17 , Kim W 17 , Okanoue T 18 , Shima T 18 , Nakajima A 19 , Yoneda M 19 , Thuluvath PJ 20 , Li F 20 , Berzigotti A 21 , Mendoza YP 21 , Noureddin M 22 , Truong E 23 , Fournier-Poizat C 24 , Geier A 25 , Tuthill T 26 , Yunis C 27 , Anstee QM 28 , Harrison SA 1 , Bossuyt PM 2 , Pavlides M 1

Affiliations 

  • 1 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, OCMR, University of Oxford, Oxford, UK
  • 2 Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  • 3 Laboratoire HIFIH, UPRES EA 3859, SFR ICAT 4208, Université d'Angers, Angers, France
  • 4 Centre d'Investigation de la Fibrose Hépatique, Hôpital Haut-Lévêque, Bordeaux University Hospital, Pessac, France
  • 5 Department of Medical Imaging, Iuliu Hațieganu University of Medicine and Pharmacy, Regional Institute of Gastroenterology and Hepatology "Prof.Dr. Octavian Fodor", Cluj-Napoca, Romania
  • 6 Department of Gastroenterology, School of Medicine, Marmara University, Istanbul, Turkey
  • 7 Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 8 Department of Oncology, Gastroenterology, Hepatology, Pulmonology and Infectious Diseases, University Hospital Leipzig, Leipzig, Germany
  • 9 Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India
  • 10 Sheila Sherlock Liver Unit and UCL Institute for Liver and Digestive Health, Royal Free Hospital and University College London, London, UK
  • 11 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
  • 12 Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
  • 13 Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  • 14 Division of Liver and Pancreatic diseases, Department of Upper GI, Karolinska University Hospital, Stockholm, Sweden
  • 15 Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden
  • 16 Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Touon, Ehime, Japan
  • 17 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Republic of Korea
  • 18 Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan
  • 19 Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan
  • 20 Institute of Digestive Health and Liver Diseases, Mercy Medical Center, Baltimore, Maryland, USA
  • 21 Department for Visceral Medicine and Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  • 22 Houston Research Institute, Houston Methodist Hospital, Houston, Texas, USA
  • 23 Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA
  • 24 Echosens, Paris, France
  • 25 Division of Hepatology, University Hospital Würzburg, Würzburg, Germany
  • 26 Internal Medicine Research Unit, Pfizer Inc, Cambridge, Massachusetts, USA
  • 27 Clinical Development and Operations, Global Product Development, Pfizer, Inc, Lake Mary, Florida, USA
  • 28 Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
Liver Int, 2024 Aug;44(8):1872-1885.
PMID: 38573034 DOI: 10.1111/liv.15914

Abstract

BACKGROUND & AIMS: There is a need to reduce the screen failure rate (SFR) in metabolic dysfunction-associated steatohepatitis (MASH) clinical trials (MASH+F2-3; MASH+F4) and identify people with high-risk MASH (MASH+F2-4) in clinical practice. We aimed to evaluate non-invasive tests (NITs) screening approaches for these target conditions.

METHODS: This was an individual participant data meta-analysis for the performance of NITs against liver biopsy for MASH+F2-4, MASH+F2-3 and MASH+F4. Index tests were the FibroScan-AST (FAST) score, liver stiffness measured using vibration-controlled transient elastography (LSM-VCTE), the fibrosis-4 score (FIB-4) and the NAFLD fibrosis score (NFS). Area under the receiver operating characteristics curve (AUROC) and thresholds including those that achieved 34% SFR were reported.

RESULTS: We included 2281 unique cases. The prevalence of MASH+F2-4, MASH+F2-3 and MASH+F4 was 31%, 24% and 7%, respectively. Area under the receiver operating characteristics curves for MASH+F2-4 were .78, .75, .68 and .57 for FAST, LSM-VCTE, FIB-4 and NFS. Area under the receiver operating characteristics curves for MASH+F2-3 were .73, .67, .60, .58 for FAST, LSM-VCTE, FIB-4 and NFS. Area under the receiver operating characteristics curves for MASH+F4 were .79, .84, .81, .76 for FAST, LSM-VCTE, FIB-4 and NFS. The sequential combination of FIB-4 and LSM-VCTE for the detection of MASH+F2-3 with threshold of .7 and 3.48, and 5.9 and 20 kPa achieved SFR of 67% and sensitivity of 60%, detecting 15 true positive cases from a theoretical group of 100 participants at the prevalence of 24%.

CONCLUSIONS: Sequential combinations of NITs do not compromise diagnostic performance and may reduce resource utilisation through the need of fewer LSM-VCTE examinations.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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