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. 2022 Oct 28;12(1):18174.
doi: 10.1038/s41598-022-22767-z.

A 3-step approach to predict advanced fibrosis in nonalcoholic fatty liver disease: impact on diagnosis, patient burden, and medical costs

Takashi Kobayashi #  1 , Yuji Ogawa #  1   2 , Satoru Shinoda  3 , Michihiro Iwaki  1 , Asako Nogami  1 , Yasushi Honda  1 , Takaomi Kessoku  1 , Kento Imajo  1   4 , Masato Yoneda  5 , Satoru Saito  1 , Kouji Yamamoto  3 , Satoshi Oeda  6 , Hirokazu Takahashi  6 , Yoshio Sumida  7 , Atsushi Nakajima  1
Affiliations

A 3-step approach to predict advanced fibrosis in nonalcoholic fatty liver disease: impact on diagnosis, patient burden, and medical costs

Takashi Kobayashi et al. Sci Rep. .

Abstract

A 2-step approach, Fibrosis-4 index (FIB-4) followed by vibration-controlled transient elastography (VCTE), has been proposed to predict advanced fibrosis in patients with nonalcoholic fatty liver disease (NAFLD). We aimed to develop a novel 3-step approach for predicting advanced fibrosis. We enrolled 284 biopsy-confirmed NAFLD patients from two tertiary care centers and developed subgroups (n = 190), including 3.7% of patients with advanced fibrosis, assuming a primary care setting. In the 3-step approach, patients with intermediate-to-high FIB-4 in the first step underwent an enhanced liver fibrosis test or measurement of type IV collagen 7S domain as the second step, and VCTE was performed if the second step value was higher than the cutoff. In 284 cases, a tertiary care cohort with 36.3% advanced fibrosis, the 3-step approach showed significantly higher specificity and positive predictive value than the 2-step approach. In the subgroup with 3.7% advanced fibrosis, the 3-step approach significantly reduced the referral rate to specialists, the number of high-risk patients (i.e., liver biopsy candidates), and healthcare costs by 12.5% to 15.8%. The 3-step approach may improve the diagnostic performance to predict advanced fibrosis in NAFLD, which could lower rates of referrals to specialists, liver biopsies, and medical costs.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Performance of each approach in the tertiary care center cohort. Number and percentages of patients evaluated using the (a) 2-step approach, (b) 3-step approach with ELF, and (c) 3-step approach with T4C7S. The numbers in the boxes and parentheses are the sum of the total patients and the number of patients without advanced fibrosis/number of patients with advanced fibrosis, respectively. The numbers on the lines are the percentages among patients with a FIB-4 score of ≥ 1.30. AF, advanced fibrosis; ELF, enhanced liver fibrosis test; FIB-4, Fibrosis-4 index; T4C7S, type IV collagen 7S domain; VCTE, vibration-controlled transient elastography.
Figure 2
Figure 2
Comparison of each approach applied to a cohort with a low prevalence of advanced fibrosis (3.7%); the 3-step approach can reduce patient referral and liver biopsy rates without losing diagnostic performance. The numbers listed are means. ELF, enhanced liver fibrosis test; FIB-4, Fibrosis-4 index; T4C7S, type IV collagen 7S domain; VCTE, vibration-controlled transient elastography; Se, sensitivity; Sp, specificity; PPV, positive predictive value; NPV, negative predictive value.
Figure 3
Figure 3
Our novel 3-step approach. The application of this approach will increase the number of patients seen by primary care physicians and decrease the number of specialist referrals. Patients considered at low risk using this approach only need to be followed up by a primary care physician, whereas those considered at high risk need to undergo additional evaluations, including liver biopsy. ELF, enhanced liver fibrosis test; FIB-4, Fibrosis-4 index; T4C7S, type IV collagen 7S domain; VCTE, vibration-controlled transient elastography.
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