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Prospective external validation of a new non‐invasive test for the diagnosis of non‐alcoholic steatohepatitis in patients with type 2 diabetes
Author(s) -
Poynard Thierry,
Paradis Valérie,
Mullaert Jimmy,
Deckmyn Olivier,
Gault Nathalie,
Marcault Estelle,
Manchon Pauline,
Si Mohammed Nassima,
Parfait Beatrice,
Ibberson Mark,
Gautier JeanFrancois,
Boitard Christian,
Czernichow Sébastien,
Larger Etienne,
Drane Fabienne,
Castille Jean Marie,
Peta Valentina,
Brzustowski Angélique,
Terris Benoit,
ValletPichard Anais,
Roulot Dominique,
Laouénan Cédric,
Bedossa Pierre,
Castera Laurent,
Pol Stanislas,
Valla Dominique
Publication year - 2021
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.16543
Subject(s) - medicine , steatohepatitis , gastroenterology , steatosis , fatty liver , receiver operating characteristic , type 2 diabetes , fibrosis , diabetes mellitus , disease , endocrinology
Summary Background One of the unmet needs in patients with type 2 diabetes mellitus (T2DM) is the prediction of non‐alcoholic liver disease by non‐invasive blood tests, for each of the three main histological features, fibrosis, non‐alcoholic steatohepatitis (NASH) and steatosis. Aims To validate externally the performances of a recent panel, Nash‐FibroTest, for the assessment of the severity of fibrosis stages, NASH grades and steatosis grades. Methods We prospectively analysed 272 patients with T2DM. Standard definitions of stages and grades were used, and analyses were centralised and blinded. The performances of the FibroTest, NashTest‐2 and SteatoTest‐2 were assessed using the Obuchowski measure (OM), the main outcome recommended as a summary measure of accuracy includeing all pairwise stages and grades comparisons, which is not provided par the extensively used binary area under the ROC curve. Results The diagnostic performance of each component of the panel was significant. OM (SE; significance) of the FibroTest, the NashTest‐2 and the SteatoTest‐2 was 0.862 (0.012; P < 0.001), 0.827 (0.015; P < 0.001) and 0.794 (0.020; P < 0.01), respectively. For ballooning and lobular inflammation, OM was 0.794 (0.021; P < 0.001) and 0.821 (0.017; P < 0.001), respectively. In a post hoc analysis the FibroTest outperformed VCTE by 4.1% (2.5‐6.5; P < 0.001) for reliability, with a non‐significant difference for OM for fibrosis staging, 0.859 (0.012) for FibroTest vs 0.870 (0.009) for VCTE. Conclusions From a single blood sample, the panel provides non‐invasive diagnosis of the stages of fibrosis, and the grades of NASH and steatosis in patients with T2DM. Trial registration number: NCT03634098.