Validation of a two-step approach combining serum biomarkers and liver stiffness measurement to predict advanced fibrosis - PubMed (original) (raw)

. 2021 Jun 10;5(7):801-808.

doi: 10.1002/jgh3.12590. eCollection 2021 Jul.

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Validation of a two-step approach combining serum biomarkers and liver stiffness measurement to predict advanced fibrosis

Hideki Fujii et al. JGH Open. 2021.

Abstract

Background and aim: The Gut and Obesity in Asia Workgroup recently reported that a two-step approach using fibrosis scores followed by liver stiffness measurement (LSM) could accurately detect patients with non-alcoholic fatty liver disease (NAFLD) having advanced fibrosis in low-risk fibrosis populations. This study aimed to validate the utility of this approach using a Japanese health checkup registry.

Methods: This cross-sectional study included subjects who underwent a health checkup from 2014 to 2019. Using estimated fibrosis stage measured by LSM as a standard, we calculated the percentage of misclassification from assessments made based on fibrosis scores (NAFLD fibrosis score [NFS] or Fibrosis-4 score [FIB-4]) and LSM, alone or in combination.

Results: Of 630 subjects with NAFLD, 4 (0.8%) had advanced fibrosis. In the first-step evaluation, only 21.4-38.0% of subjects needed further testing. This approach was associated with a high specificity of approximately 100% and a negative predictive value of 99.7%. The percentage of misclassification based on NFS or FIB-4 values followed by LSM in all subjects and using LSM after NFS or FIB-4 determination only in subjects with indeterminate/high NFS or FIB-4 values (two-step approach) was 0% and 0.3% and 0.16% and 0.3%, respectively. In addition, very few false negatives occurred for both NFS and FIB-4.

Conclusion: The two-step approach helps to identify the subjects with NAFLD who have advanced fibrosis during a routine health checkup and is associated with only a few false negatives.

Keywords: hepatic fibrosis; noninvasive fibrosis test; non‐alcoholic fatty liver disease; transient elastography.

© 2021 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

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Figures

Figure 1

Figure 1

(a) The two‐step approach and (b) both tests for all subjects. LSM, liver stiffness measurement; NAFLD, nonalcoholic liver disease; NFS, NAFLD fibrosis score.

Figure 2

Figure 2

Flow diagram of the study subjects. Ab, antibody; HbA1c, hemoglobin A1c; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; LSM, liver stiffness measurement; SR, success rate; IQR/med, interquartile range/median.

Figure 3

Figure 3

Diagnostic performance of fatty liver based on CAP. AUROC, area under the receiver operating characteristic curve; CAP, controlled attenuation parameter; NPV, negative predictive value; PPV, positive predictive value; Se, sensitivity; Sp, specificity.

Figure 4

Figure 4

Boxplots showing the NAFLD fibrosis score, FIB‐4 value, and liver stiffness measurement value of subjects with and without advanced fibrosis in the overall study population. FIB‐4, Fibrosis‐4; NAFLD, non‐alcoholic fatty liver disease.

References

    1. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease‐meta‐analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016; 64: 73–84. - PubMed
    1. Chalasani N, Younossi Z, Lavine JE et al. The diagnosis and management of nonalcoholic fatty liver disease: practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018; 67: 328–57. - PubMed
    1. European Association for the Study of the Liver (EASL), European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO) . EASL‐EASD‐EASO Clinical Practice Guidelines for the management of non‐alcoholic fatty liver disease. J. Hepatol. 2016; 64: 1388–402. - PubMed
    1. Wong VW, Chan WK, Chitturi S et al. Asia‐Pacific Working Party on Non‐alcoholic Fatty Liver Disease guidelines 2017‐Part 1: Definition, risk factors and assessment. J. Gastroenterol. Hepatol. 2018; 33: 70–85. - PubMed
    1. Angulo P, Kleiner DE, Dam‐Larsen S et al. Liver fibrosis, but no other histologic features, is associated with long‐term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2015; 149: 389–97. - PMC - PubMed

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