Lipids & metabolic liver disease

Screening for Metabolic Dysfunction–Associated Steatotic Liver Disease–Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study

Diabetes CarePublished Diagnostic accuracy study

Authors' conclusion

The FIB-4 score/VCTE algorithm showed excellent diagnostic performance, demonstrating its applicability for routine screening in diabetology. The ELF test using an adapted low threshold at 9.8 may be used as an alternative to VCTE.

Study context

Population
Patients with T2D and/or obesity and MASLD in diabetology; 87% T2D, 56% male, 74% with obesity
Participants
654 patients
Comparison
Blood-based noninvasive tests (NITs), vibration-controlled transient elastography (VCTE) and 2D-SWE vs two-step algorithms (FIB-4 then second test) for detecting high risk of advanced fibrosis (AF)
Outcome
Detection of high risk of AF (composite reference:
  • Liver biopsy
  • Magnetic resonance elastography
  • VCTE ≥12 kPa depending on availability)
Methodological detailsprospective, multicenter, planned interim analysis
  • Prospective
  • Multicenter
  • Planned interim analysis

Performance

As reported in the abstract

Detection of high risk of AF
Test or modelAUCPerformanceNPVPPV
FIB-40.78 (95% CI 0.72-0.84)
FibroMeter0.74 (0.66-0.83)
FibroTest0.78 (0.72-0.85)
Enhanced Liver Fibrosis (ELF)0.82 (0.76-0.87)
SWE0.84 (0.78-0.89)
FIB-4/VCTEgood diagnostic performance for referral of intermediate/high risk of AF
FIB-4/ELF88-89%39-46%
FIB-4/2D-SWE91%58-62%

AUC

FIB-40.78 (95% CI 0.72-0.84)
FibroMeter0.74 (0.66-0.83)
FibroTest0.78 (0.72-0.85)
Enhanced Liver Fibrosis (ELF)0.82 (0.76-0.87)
SWE0.84 (0.78-0.89)
FIB-4/VCTE— not stated in the abstract
FIB-4/ELF— not stated in the abstract
FIB-4/2D-SWE— not stated in the abstract

Performance

FIB-4— not stated in the abstract
FibroMeter— not stated in the abstract
FibroTest— not stated in the abstract
Enhanced Liver Fibrosis (ELF)— not stated in the abstract
SWE— not stated in the abstract
FIB-4/VCTEgood diagnostic performance for referral of intermediate/high risk of AF
FIB-4/ELF— not stated in the abstract
FIB-4/2D-SWE— not stated in the abstract

NPV

FIB-4— not stated in the abstract
FibroMeter— not stated in the abstract
FibroTest— not stated in the abstract
Enhanced Liver Fibrosis (ELF)— not stated in the abstract
SWE— not stated in the abstract
FIB-4/VCTE— not stated in the abstract
FIB-4/ELF88-89%
FIB-4/2D-SWE91%

PPV

FIB-4— not stated in the abstract
FibroMeter— not stated in the abstract
FibroTest— not stated in the abstract
Enhanced Liver Fibrosis (ELF)— not stated in the abstract
SWE— not stated in the abstract
FIB-4/VCTE— not stated in the abstract
FIB-4/ELF39-46%
FIB-4/2D-SWE58-62%

Further findings

Prevalence of AF risk

Intermediate/high risk of AF
17.6%
High risk of AF
9.3%

Age-adapted FIB-4 threshold

Lower NPVs and PPVs in all algorithms

Original publication

Screening for Metabolic Dysfunction–Associated Steatotic Liver Disease–Related Advanced Fibrosis in Diabetology: A Prospective Multicenter Study. Diabetes Care. Published 31 January 2025. doi:10.2337/dc24-2075

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