Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial
Abstract Background: Increasing prevalence of metabolic dysfunction–associated liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility an...
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Nature Portfolio
2025-03-01
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| Series: | Communications Medicine |
| Online Access: | https://doi.org/10.1038/s43856-025-00796-9 |
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| author | Elizabeth Shumbayawonda Marika French Jane Elizabeth Carolan Cayden Beyer Paula Lorgelly Dimitar Tonev Rajarshi Banerjee Michael H. Miller Christopher D. Byrne Janisha Patel Saima Ajaz Kosh Agarwal Johanna Backhus Minneke J. Coenraad Jelte J. Schaapman Andrew Fraser Miguel Castelo Branco Stephen Barclay Matthias M. Dollinger Daniel J. Cuthbertson Daniel Forton Hildo J. Lamb |
| author_facet | Elizabeth Shumbayawonda Marika French Jane Elizabeth Carolan Cayden Beyer Paula Lorgelly Dimitar Tonev Rajarshi Banerjee Michael H. Miller Christopher D. Byrne Janisha Patel Saima Ajaz Kosh Agarwal Johanna Backhus Minneke J. Coenraad Jelte J. Schaapman Andrew Fraser Miguel Castelo Branco Stephen Barclay Matthias M. Dollinger Daniel J. Cuthbertson Daniel Forton Hildo J. Lamb |
| author_sort | Elizabeth Shumbayawonda |
| collection | DOAJ |
| description | Abstract Background: Increasing prevalence of metabolic dysfunction–associated liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility and cost-effectiveness of including multiparametric magnetic resonance imaging (mpMRI) to the management of adults with suspected MASLD multi-nationally. Methods: RADIcAL-1, a 1:1 randomised controlled trial (standard-of-care [SoC] vs. imaging arm [IA; SoC+mpMRI]) included 802 participants from Germany, Netherlands, Portugal and UK. Wilcoxon-rank tests were used to compare access to healthcare practitioners, patient assessments and proportion of patients with a diagnosis (%diagnosis). Liver fat and disease activity (corrected T1 [cT1]) were used to identify patients not requiring biopsy in the imaging arm. Primary endpoint was mpMRI cost-effectiveness and improvement in resource use (visits avoided) using mpMRI. Results: mpMRI is cost-effective with an ICER of €4968/QALY gained. 403 were randomised to IA and 399 to SoC. SoC has significantly more specialist appointments (p = 0.015) and patient assessments (p < 0.001). Across all involved hospitals, %diagnosis is significantly higher in the imaging arm (p = 0.0012). cT1 correctly classifies 50% of patients without MASH with fibrosis and can avoid biopsy. Including all costs, the imaging arm incurs higher short-term per-patient healthcare expenditure compared to the SoC arm (€1,300 vs. €830). Conclusion: Adding mpMRI to SoC for the management of adults with suspected MASLD multi-nationally is cost-effective, enhances rate of diagnosis multi-nationally and increases rate of diagnosis without increasing other liver-related health care resource use. Due to the need for standardisation of SoC, widespread use can support optimisation of the MASLD clinical pathway and improve long-term patient management. |
| format | Article |
| id | doaj-art-b54200cfc641444fbd6a283521ea6a94 |
| institution | DOAJ |
| issn | 2730-664X |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Nature Portfolio |
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| spelling | doaj-art-b54200cfc641444fbd6a283521ea6a942025-08-20T03:06:57ZengNature PortfolioCommunications Medicine2730-664X2025-03-015111310.1038/s43856-025-00796-9Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trialElizabeth Shumbayawonda0Marika French1Jane Elizabeth Carolan2Cayden Beyer3Paula Lorgelly4Dimitar Tonev5Rajarshi Banerjee6Michael H. Miller7Christopher D. Byrne8Janisha Patel9Saima Ajaz10Kosh Agarwal11Johanna Backhus12Minneke J. Coenraad13Jelte J. Schaapman14Andrew Fraser15Miguel Castelo Branco16Stephen Barclay17Matthias M. Dollinger18Daniel J. Cuthbertson19Daniel Forton20Hildo J. Lamb21Perspectum LtdPerspectum LtdPerspectum LtdPerspectum LtdInstitute of Health Informatics, University College LondonPerspectum LtdPerspectum LtdNinewells HospitalSouthampton National Institute for Health and Care Research Biomedical Research Centre, University Hospital Southampton, Southampton General HospitalSouthampton National Institute for Health and Care Research Biomedical Research Centre, University Hospital Southampton, Southampton General HospitalInstitute of Liver Studies, Kings College HospitalInstitute of Liver Studies, Kings College HospitalUniversity Hospital UlmDepartment of Gastroenterology and Hepatology, Leiden University Medical CenterDepartment of Gastroenterology and Hepatology, Leiden University Medical CenterConsultant Hepatologist and Gastroenterologist, Queen Elizabeth University HospitalCIBIT (Coimbra Institute for Biomedical Imaging and Translational) Research, Faculdade de Medicina, Instituto de Ciências Nucleares Aplicadas à Saúde, Universidade de CoimbraGlasgow Royal InfirmaryUniversity Hospital UlmDepartment of Cardiovascular and Metabolic Medicine, University of LiverpoolDepartment of Gastroenterology and Hepatology, St. George’s HospitalDepartment of Radiology, Leiden University Medical CenterAbstract Background: Increasing prevalence of metabolic dysfunction–associated liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH) poses a growing healthcare burden. Noninvasive diagnostic tools to replace liver biopsy are urgently needed. We investigated the utility and cost-effectiveness of including multiparametric magnetic resonance imaging (mpMRI) to the management of adults with suspected MASLD multi-nationally. Methods: RADIcAL-1, a 1:1 randomised controlled trial (standard-of-care [SoC] vs. imaging arm [IA; SoC+mpMRI]) included 802 participants from Germany, Netherlands, Portugal and UK. Wilcoxon-rank tests were used to compare access to healthcare practitioners, patient assessments and proportion of patients with a diagnosis (%diagnosis). Liver fat and disease activity (corrected T1 [cT1]) were used to identify patients not requiring biopsy in the imaging arm. Primary endpoint was mpMRI cost-effectiveness and improvement in resource use (visits avoided) using mpMRI. Results: mpMRI is cost-effective with an ICER of €4968/QALY gained. 403 were randomised to IA and 399 to SoC. SoC has significantly more specialist appointments (p = 0.015) and patient assessments (p < 0.001). Across all involved hospitals, %diagnosis is significantly higher in the imaging arm (p = 0.0012). cT1 correctly classifies 50% of patients without MASH with fibrosis and can avoid biopsy. Including all costs, the imaging arm incurs higher short-term per-patient healthcare expenditure compared to the SoC arm (€1,300 vs. €830). Conclusion: Adding mpMRI to SoC for the management of adults with suspected MASLD multi-nationally is cost-effective, enhances rate of diagnosis multi-nationally and increases rate of diagnosis without increasing other liver-related health care resource use. Due to the need for standardisation of SoC, widespread use can support optimisation of the MASLD clinical pathway and improve long-term patient management.https://doi.org/10.1038/s43856-025-00796-9 |
| spellingShingle | Elizabeth Shumbayawonda Marika French Jane Elizabeth Carolan Cayden Beyer Paula Lorgelly Dimitar Tonev Rajarshi Banerjee Michael H. Miller Christopher D. Byrne Janisha Patel Saima Ajaz Kosh Agarwal Johanna Backhus Minneke J. Coenraad Jelte J. Schaapman Andrew Fraser Miguel Castelo Branco Stephen Barclay Matthias M. Dollinger Daniel J. Cuthbertson Daniel Forton Hildo J. Lamb Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial Communications Medicine |
| title | Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial |
| title_full | Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial |
| title_fullStr | Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial |
| title_full_unstemmed | Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial |
| title_short | Utility and cost-effectiveness of LiverMultiScan for MASLD diagnosis: a real-world multi-national randomised clinical trial |
| title_sort | utility and cost effectiveness of livermultiscan for masld diagnosis a real world multi national randomised clinical trial |
| url | https://doi.org/10.1038/s43856-025-00796-9 |
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