Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol.

Non-alcoholic fatty liver disease (NAFLD) is the liver manifestation of the metabolic syndrome with global prevalence reaching epidemic levels. Despite the high disease burden in the population only a small proportion of those with NAFLD will develop progressive liver disease, for which there is currently no approved pharmacotherapy. Identifying those who are at risk of progressive NAFLD currently requires a liver biopsy which is problematic. Firstly, liver biopsy is invasive and therefore not appropriate for use in a condition like NAFLD that affects a large proportion of the population. Secondly, biopsy is limited by sampling and observer dependent variability which can lead to misclassification of disease severity. Non-invasive biomarkers are therefore needed to replace liver biopsy in the assessment of NAFLD. Our study addresses this unmet need. The LITMUS Imaging Study is a prospectively recruited multi-centre cohort study evaluating magnetic resonance imaging and elastography, and ultrasound elastography against liver histology as the reference standard. Imaging biomarkers and biopsy are acquired within a 100-day window. The study employs standardised processes for imaging data collection and analysis as well as a real time central monitoring and quality control process for all the data submitted for analysis. It is anticipated that the high-quality data generated from this study will underpin changes in clinical practice for the benefit of people with NAFLD. Study Registration: clinicaltrials.gov: NCT05479721.

Predicting 6-week mortality after acute variceal bleeding: role of Classification and Regression Tree analysis.

BACKGROUND: Available prognostic scores for mortality after acute variceal bleeding are mainly based on logistic regression analysis but may have some limitations that can restrict their clinical value. AIMS: To assess the efficacy of a novel prognostic approach based on Classification and Regression Tree -CART- analysis to common easy-to-use models (MELD and Child-Pugh) for predicting 6-week mortality in patients with variceal bleeding. METHODS: Sixty consecutive cirrhotic patients with acute variceal bleeding. CART analysis, MELD and Child-Pugh scores were performed to assess 6-week mortality. Receiver operating characteristic (ROC) curves were constructed to evaluate the predictive performance of the models. RESULTS: Six-week rebleeding and mortality were 30% and 22%, respectively. Child-Pugh and MELD scores were clinically relevant for predicting 6 weeks mortality. CART analysis provided a simple algorithm based on just three bedside-available variables (albumin, bilirubin and in-hospital rebleeding), allowing accurate discrimination of two distinct prognostic subgroups with 3% and 80% mortality rates. All MELD, Child-Pugh and CART models showed excellent and comparable predictive accuracy, with areas under the ROC curves (AUROC) of 0.88, 0.84 and 0.91, respectively. CONCLUSIONS: A simple CART algorithm combining albumin, bilirubin and in-hospital rebleeding allows an accurate predictive assessment of 6-week mortality after acute variceal bleeding.