Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis
© 2024 The Authors. Liver International published by John Wiley & Sons Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Liver international : official journal of the International Association for the Study of the Liver - (2024) vom: 04. Apr. |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
At‐risk MASH |
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| Anmerkungen: |
Date Revised 04.04.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1111/liv.15914 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Diagnostic accuracy of non-invasive tests to screen for at-risk MASH-An individual participant data meta-analysis |
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| 520 | |a © 2024 The Authors. Liver International published by John Wiley & Sons Ltd. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a CONCLUSIONS: Sequential combinations of NITs do not compromise diagnostic performance and may reduce resource utilisation through the need of fewer LSM-VCTE examinations | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a FAST | |
| 650 | 4 | |a FIB‐4 | |
| 650 | 4 | |a LSM‐VCTE | |
| 650 | 4 | |a MASH | |
| 650 | 4 | |a NFS | |
| 650 | 4 | |a at‐risk MASH | |
| 650 | 4 | |a non‐invasive tests | |
| 700 | 1 | |a Lee, Jenny A |e verfasserin |4 aut | |
| 700 | 1 | |a Vali, Yasaman |e verfasserin |4 aut | |
| 700 | 1 | |a Selvaraj, Emmanuel A |e verfasserin |4 aut | |
| 700 | 1 | |a Jayaswal, Arjun N A |e verfasserin |4 aut | |
| 700 | 1 | |a Boursier, Jérôme |e verfasserin |4 aut | |
| 700 | 1 | |a de Lédinghen, Victor |e verfasserin |4 aut | |
| 700 | 1 | |a Lupșor-Platon, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Yilmaz, Yusuf |e verfasserin |4 aut | |
| 700 | 1 | |a Chan, Wah-Kheong |e verfasserin |4 aut | |
| 700 | 1 | |a Mahadeva, Sanjiv |e verfasserin |4 aut | |
| 700 | 1 | |a Karlas, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Wiegand, Johannes |e verfasserin |4 aut | |
| 700 | 1 | |a Shalimar |e verfasserin |4 aut | |
| 700 | 1 | |a Tsochatzis, Emmanouil |e verfasserin |4 aut | |
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| 700 | 1 | |a Holleboom, Adriaan G |e verfasserin |4 aut | |
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| 700 | 1 | |a Hagström, Hannes |e verfasserin |4 aut | |
| 700 | 1 | |a Akbari, Camilla |e verfasserin |4 aut | |
| 700 | 1 | |a Hirooka, Masashi |e verfasserin |4 aut | |
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| 700 | 1 | |a Thuluvath, Paul J |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Berzigotti, Annalisa |e verfasserin |4 aut | |
| 700 | 1 | |a Mendoza, Yuly P |e verfasserin |4 aut | |
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