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Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis
Ferenc E Mózes1, Jenny A Lee2, Yasaman Vali2
1Division of Cardiovascular Medicine, Radcliffe Department of Medicine, OCMR, University of Oxford, Oxford, UK.
Background & Aims:
There is a need to reduce the screen failure rate (SFR) in metabolic dysfunction-associated steatohepatitis (MASH) clinical trials (MASH+F2-3; MASH+F4) and identify people with high-risk MASH (MASH+F2-4) in clinical practice. We aimed to evaluate non-invasive tests (NITs) screening approaches for these target conditions.
Methods:
This was an individual participant data meta-analysis for the performance of NITs against liver biopsy for MASH+F2-4, MASH+F2-3 and MASH+F4. Index tests were the FibroScan-AST (FAST) score, liver stiffness measured using vibration-controlled transient elastography (LSM-VCTE), the fibrosis-4 score (FIB-4) and the NAFLD fibrosis score (NFS). Area under the receiver operating characteristics curve (AUROC) and thresholds including those that achieved 34% SFR were reported.
Results:
We included 2281 unique cases. The prevalence of MASH+F2-4, MASH+F2-3 and MASH+F4 was 31%, 24% and 7%, respectively. Area under the receiver operating characteristics curves for MASH+F2-4 were .78, .75, .68 and .57 for FAST, LSM-VCTE, FIB-4 and NFS. Area under the receiver operating characteristics curves for MASH+F2-3 were .73, .67, .60, .58 for FAST, LSM-VCTE, FIB-4 and NFS. Area under the receiver operating characteristics curves for MASH+F4 were .79, .84, .81, .76 for FAST, LSM-VCTE, FIB-4 and NFS. The sequential combination of FIB-4 and LSM-VCTE for the detection of MASH+F2-3 with threshold of .7 and 3.48, and 5.9 and 20 kPa achieved SFR of 67% and sensitivity of 60%, detecting 15 true positive cases from a theoretical group of 100 participants at the prevalence of 24%.
Conclusions:
Sequential combinations of NITs do not compromise diagnostic performance and may reduce resource utilisation through the need of fewer LSM-VCTE examinations.
Insights
Sequential non-invasive tests (NITs) effectively screen for metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis (MASH+F2-4) and reduce trial screening failure rates (SFR). This approach improves MASH diagnosis and clinical trial efficiency.
Area of Science:
- Hepatology
- Clinical Diagnostics
- Medical Imaging
Background:
- Metabolic dysfunction-associated steatohepatitis (MASH) presents challenges in clinical trials due to high screen failure rates (SFR).
- Accurate identification of high-risk MASH (MASH+F2-4) is crucial for both clinical practice and research.
Purpose of the Study:
- To evaluate non-invasive tests (NITs) for screening MASH patients with advanced fibrosis (MASH+F2-4).
- To assess NIT performance in reducing SFR in MASH clinical trials (MASH+F2-3 and MASH+F4).
Main Methods:
- Individual participant data meta-analysis comparing NITs (FAST score, LSM-VCTE, FIB-4, NFS) against liver biopsy.
- Analysis of diagnostic performance using AUROC and thresholds for achieving 34% SFR.
Main Results:
- The FAST score demonstrated the highest AUROC for MASH+F2-4 (0.78) and MASH+F2-3 (0.73).
- Sequential combination of FIB-4 and LSM-VCTE achieved 67% SFR and 60% sensitivity for MASH+F2-3.
- Liver stiffness measurement by VCTE showed high performance for MASH+F4 (AUROC 0.84).
Conclusions:
- Sequential NIT combinations maintain diagnostic accuracy while potentially reducing resource utilization.
- Fewer liver stiffness measurements (LSM-VCTE) may be needed when using sequential NIT strategies.
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