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Diagnostic accuracy of non-invasive tests for advanced fibrosis in patients with NAFLD: an individual patient data meta-analysis

Mózes, Ferenc Emil, Lee, Jenny A, Selvaraj, Emmanuel Anandraj, Jayaswal, Arjun Narayan Ajmer, Trauner, Michael, Boursier, Jerome, Fournier, Céline, Staufer, Katharina +45 more·2022·Gut
DOI 10.1136/gutjnl-2021-324243PMC PMC8995830
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Abstract

Objective: Liver biopsy is still needed for fibrosis staging in many patients with non-alcoholic fatty liver disease. The aims of this study were to evaluate the individual diagnostic performance of liver stiffness measurement by vibration controlled transient elastography (LSM-VCTE), Fibrosis-4 Index (FIB-4) and NAFLD (non-alcoholic fatty liver disease) Fibrosis Score (NFS) and to derive diagnostic strategies that could reduce the need for liver biopsies. Design: Individual patient data meta-analysis of studies evaluating LSM-VCTE against liver histology was conducted. FIB-4 and NFS were computed where possible. Sensitivity, specificity and area under the receiver operating curve (AUROC) were calculated. Biomarkers were assessed individually and in sequential combinations. Results: Data were included from 37 primary studies (n=5735; 45% women; median age: 54 years; median body mass index: 30 kg/m 2 ; 33% had type 2 diabetes; 30% had advanced fibrosis). AUROCs of individual LSM-VCTE, FIB-4 and NFS for advanced fibrosis were 0.85, 0.76 and 0.73. Sequential combination of FIB-4 cut-offs (<1.3; ≥2.67) followed by LSM-VCTE cut-offs (<8.0; ≥10.0 kPa) to rule-in or rule-out advanced fibrosis had sensitivity and specificity (95% CI) of 66% (63–68) and 86% (84–87) with 33% needing a biopsy to establish a final diagnosis. FIB-4 cut-offs (<1.3; ≥3.48) followed by LSM cut-offs (<8.0; ≥20.0 kPa) to rule out advanced fibrosis or rule in cirrhosis had a sensitivity of 38% (37–39) and specificity of 90% (89–91) with 19% needing biopsy. Conclusion: Sequential combinations of markers with a lower cut-off to rule-out advanced fibrosis and a higher cut-off to rule-in cirrhosis can reduce the need for liver biopsies.

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  • In NAFLD, the threshold for ruling-out/in advanced fibrosis ranges between 9.9 and 11.4 kPa in the STELLAR trials, while a large meta-analysis reported a lower threshold of 7.4 kPa (90% sensitivity) and upper threshold of 12.1 kPa (90% specificity).

    “In the specific etiology of NAFLD, the threshold for ruling‐out/in advanced fibrosis ranges between 9.9 and 11.4 kPa in the STELLAR trials [73] while in a recently published large meta‐analysis a lower threshold of 7.4 kPa (90% Sensitivity) and upper threshold of 12.1 kPa (90% specificity) was published [74].”

    From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [74]

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Authors
Mózes, F. E., Lee, J. A., Selvaraj, E. A., Jayaswal, A. N. A., Trauner, M., Boursier, J., Fournier, C., Staufer, K., Stauber, R. E., Bugianesi, E., Younes, R., Gaia, S., Lupșor-Platon, M., Petta, S., Shima, T., Okanoue, T., Mahadeva, S., Chan, W.-K., Eddowes, P. J., Hirschfield, G. M., Newsome, P. N., Wong, V. W.-S., de Ledinghen, V., Fan, J., Shen, F., Cobbold, J. F., Sumida, Y., Okajima, A., Schattenberg, J. M., Labenz, C., Kim, W., Lee, M. S., Wiegand, J., Karlas, T., Yılmaz, Y., Aithal, G. P., Palaniyappan, N., Cassinotto, C., Aggarwal, S., Garg, H., Ooi, G. J., Nakajima, A., Yoneda, M., Ziol, M., Barget, N., Geier, A., Tuthill, T., Brosnan, M. J., Anstee, Q. M., Neubauer, S., Harrison, S. A., Bossuyt, P. M., & Pavlides, M.
Affiliations
  • Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK
  • Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
  • Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria
  • Laboratoire HIFIH, UPRES EA 3859, SFR ICAT 4208, Universite d'Angers, Angers, Pays de la Loire, France
  • Echosens SA, Paris, Île-de-France, France
  • Department of Internal Medicine, Medical University of Graz, Graz, Austria
  • Medical Sciences, University of Turin, Torino, Italy
  • Boehringer Ingelheim International GmbH, Ingelheim, Rheinland-Pfalz, Germany
  • Department of Ultrasonography, University of Medicine and Pharmacy, Regional Institute of Gastroenterology and Hepatology “Prof. Dr. Octavian Fodor”, Cluj Napoca, Romania
  • Section of Gastroenterology and Hepatology, PROMISE, Palermo, Italy
  • Hepatology Center, Saiseikai Suita Hospital, Suita, Osaka, Japan
  • Faculty of Medicine, Department of Medicine, University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia
  • NIHR Biomedical Research Centre, University of Birmingham, Birmingham, UK
  • Toronto Centre for Liver Disease, University Health Network, Toronto, Ontario, Canada
  • Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, Hong Kong
  • Centre d'Investigation de la Fibrose Hépatique, Hopital Haut-Leveque, Pessac, France
  • Department of Gastroenterology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • Translational Gastroenterology Unit, University of Oxford, Oxford, Oxfordshire, UK
  • Department of Internal Medicine, Aichi Medical University, Nagakute, Aichi, Japan
  • Department of Gastroenterology, Koseikai Takeda Hospital, Kyoto, Japan
  • Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Rhineland-Palatinate, Germany
  • Department of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, South Korea
  • Department of Radiology, Seoul National University Seoul Metropolitan Government Boramae Medical Center, Dongjak-gu, Seoul, The Republic of Korea
  • Department of Medicine II, Leipzig University Medical Center, Leipzig, Sachsen, Germany
  • Department of Gastroenterology, Marmara University School of Medicine, Istanbul, Turkey
  • NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK
  • Diagnostic and Interventional Radiology, University Hospital Centre Montpellier, Montpellier, Languedoc-Roussillon, France
  • Department of Surgical Disciplines, AIIMS, New Delhi, Delhi, India
  • Department of Surgery, Monash University, Prahran, Victoria, Australia
  • Department of Gastroenterology and Hepatology, Yokohama City University, Yokohama, Kanagawa, Japan
  • Service d'Anatomie Pathologique et Centre de Ressources Biologiques, Hopital Jean Verdier, Paris, France
  • Centre de Ressources Biologiques, Hopitaux Universitaires Paris-Seine-Saint-Denis, Bondy, Île-de-France, France
  • Division of Hepatology, University Hospital Wurzburg, Wurzburg, Bayern, Germany
  • Internal Medicine Research Unit, Pfizer Inc, Cambridge, Massachusetts, USA
  • Translational and Clinical Research Institute, Faculty of Medicine, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
ORCID
Venue
Gut
Publisher
BMJ
Published
2021-05-17
Volume
71
Issue
5
Pages
1006-1019
ISSN
  • 0017-5749
  • 1468-3288
DOI
10.1136/gutjnl-2021-324243
PMC
PMC8995830
Cited by
477
References
8
Language
en
Licence
creativecommons.org/licenses/by-nc/4.0/ (unspecified)
Funders
Innovative Medicines Initiative 2 (777377)

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

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