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

  • Integrated BioBank of Luxembourg
May 17, 2021 By:
  • Mozes FE
  • Lee JA
  • Selvaraj EA
  • Jayaswal ANA
  • Trauner M
  • Boursier J
  • Fournier C
  • Staufer K
  • Stauber RE
  • Bugianesi E
  • Younes R
  • Gaia S
  • Lupsor-Platon M
  • Petta S
  • Shima T
  • Okanoue T
  • Mahadeva S
  • Chan WK
  • Eddowes PJ
  • Newsome PN
  • Wong VW
  • de Ledinghen V
  • Fan J
  • Shen F
  • Cobbold JF
  • Sumida Y
  • Okajima A
  • Schattenberg JM
  • Labenz C
  • Kim W
  • Lee MS
  • Wiegand J
  • Karlas T
  • Yilmaz Y
  • Aithal GP
  • Palaniyappan N
  • Cassinotto C
  • Aggarwal S
  • Garg H
  • Ooi GJ
  • Nakajima A
  • Yoneda M
  • Ziol M
  • Barget N
  • Geier A
  • Tuthill T
  • Brosnan MJ
  • Anstee QM
  • Neubauer S
  • Harrison SA
  • Bossuyt PM
  • Pavlides M
  • LITMUS Investigators (Betsou F Sandt E and Tonini M for Integrated Biobank of Luxembourg).

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.

2021 May. Gut. Online ahead of print.
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