Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis.

Mózes, Ferenc E; Lee, Jenny A; Vali, Yasaman; Selvaraj, Emmanuel A; Jayaswal, Arjun N A; Boursier, Jérôme; de Lédinghen, Victor; Lupșor-Platon, Monica; Yilmaz, Yusuf; Chan, Wah-Kheong; Mahadeva, Sanjiv; Karlas, Thomas; Wiegand, Johannes; Shalimar, Shalimar; Tsochatzis, Emmanouil; Liguori, Antonio; Wong, Vincent Wai-Sun; Lee, Dae Ho; Holleboom, Adriaan G; van Dijk, Anne-Marieke; ... (2024). Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis. (In Press). Liver international Wiley 10.1111/liv.15914

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR)
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine

Graduate School:

Graduate School for Health Sciences (GHS)

UniBE Contributor:

Berzigotti, Annalisa, Mendoza Jaimes, Yuly Paulin

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1478-3231

Publisher:

Wiley

Language:

English

Submitter:

Pubmed Import

Date Deposited:

08 Apr 2024 13:03

Last Modified:

09 Apr 2024 03:28

Publisher DOI:

10.1111/liv.15914

PubMed ID:

38573034

Uncontrolled Keywords:

FAST FIB‐4 LSM‐VCTE MASH NFS at‐risk MASH non‐invasive tests

BORIS DOI:

10.48350/195678

URI:

https://boris.unibe.ch/id/eprint/195678

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