Clin Mol Hepatol.
2024 Sep;30(suppl):s147-s158. 10.3350/cmh.2024.0330.
Diagnostic accuracy of the Fibrosis-4 index for advanced liver fibrosis in nonalcoholic fatty liver disease with type 2 diabetes: A systematic review and meta-analysis
- Affiliations
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- 1The Catholic University Liver Research Center, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 2Department of Internal Medicine, College of Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea
- 3Department of Internal Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 4Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea
- 5Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
- 6Department of Gastroenterology, CHA Bundang Medical Center, CHA University, Seongnam, Korea
- 7Department of Gastroenterology and Hepatology, Hanyang University College of Medicine, Guri, Korea
- 8Clinical Evidence Research, National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, Korea
- 9Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
- 10Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
- KMID: 2559588
- DOI: http://doi.org/10.3350/cmh.2024.0330
Abstract
- Background/Aims
The Fibrosis-4 index (FIB-4) is a noninvasive test widely used to rule out advanced liver fibrosis (AF) in patients with nonalcoholic fatty liver disease (NAFLD). However, its diagnostic accuracy in NAFLD patients with type 2 diabetes mellitus (T2DM) is controversial due to the high prevalence of AF in this population.
Methods
Research focusing on the diagnostic accuracy of FIB-4 for liver fibrosis as validated by liver histology in NAFLD patients with T2DM was included, and 12 studies (n=5,624) were finally included in the meta-analysis. Sensitivity, specificity, hierarchical summary receiver operating characteristic (HSROC), positive predictive values (PPVs), and negative predictive values (NPVs) at low cutoffs (1.3–1.67) and high cutoffs (2.67–3.25) for ruling in and out AF were calculated.
Results
At low cutoffs, the meta-analysis revealed a sensitivity of 0.74, specificity of 0.62, and HSROC of 0.75. At high cutoffs, the analysis showed a sensitivity of 0.33, specificity of 0.92, and HSROC of 0.85, suggesting FIB-4 as useful for identifying or excluding AF. In subgroup analyses, high mean age and F3 prevalence were associated with lower sensitivity. The calculated NPV and PPV were 0.82 and 0.49 at low cutoffs, whereas the NPV was 0.28 and the PPV was 0.70 at high cutoffs. There were insufficient estimated NPVs <0.90 at a hypothesized prevalence of AF >30% at an FIB-4 cutoff range of 1.3–1.67.
Conclusions
Collectively, FIB-4 has moderate diagnostic accuracy for identifying or excluding AF in NAFLD patients with T2DM, but more evidence must be accumulated due to the limited number of currently reported studies and their heterogeneity.
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