Shumbayawonda Elizabeth, French Marika, Carolan Jane Elizabeth, Beyer Cayden, Lorgelly Paula, Tonev Dimitar, Banerjee Rajarshi, Miller Michael H, Byrne Christopher D, Patel Janisha, Ajaz Saima, Agarwal Kosh, Backhus Johanna, Coenraad Minneke J, Schaapman Jelte J, Fraser Andrew, Castelo Branco Miguel, Barclay Stephen, Dollinger Matthias M, Cuthbertson Daniel J, Forton Daniel, Lamb Hildo J
Perspectum Ltd, Oxford, UK.
Institute of Health Informatics, University College London, London, UK.
Commun Med (Lond). 2025 Mar 18;5(1):74. doi: 10.1038/s43856-025-00796-9.
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.
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.
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).
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.
代谢功能障碍相关肝病（MASLD）和代谢功能障碍相关脂肪性肝炎（MASH）的患病率不断上升，给医疗保健带来了日益沉重的负担。迫切需要能够替代肝活检的非侵入性诊断工具。我们在多国范围内研究了将多参数磁共振成像（mpMRI）纳入疑似MASLD成人患者管理中的效用和成本效益。
RADIcAL-1是一项1:1随机对照试验（标准治疗[SoC]组与成像组[IA；SoC + mpMRI]），纳入了来自德国、荷兰、葡萄牙和英国的802名参与者。采用Wilcoxon秩和检验来比较获得医疗保健从业者的机会、患者评估以及确诊患者的比例（%确诊率）。在成像组中，使用肝脏脂肪和疾病活动度（校正T1[cT1]）来识别无需进行活检的患者。主要终点是mpMRI的成本效益以及使用mpMRI在资源利用方面的改善（避免就诊）。
mpMRI具有成本效益，增量成本效果比为每获得一个质量调整生命年（QALY）4968欧元。403人被随机分配到IA组，399人被分配到SoC组。SoC组有更多的专科门诊预约（p = 0.015）和患者评估（p < 0.001）。在所有参与的医院中，成像组的%确诊率显著更高（p = 0.0012）。cT1能够正确分类50%无MASH且有纤维化的患者，并且可以避免活检。包括所有成本在内，与SoC组相比，成像组的每位患者短期医疗保健支出更高（1300欧元对830欧元）。
在多国范围内，将mpMRI添加到SoC用于疑似MASLD成人患者的管理具有成本效益，提高了多国范围内的诊断率，且在不增加其他肝脏相关医疗保健资源利用的情况下提高了诊断率。由于SoC需要标准化，广泛应用可以支持优化MASLD临床路径并改善长期患者管理。
