Majumdar, A;
Campos, S;
Gurusamy, K;
Pinzani, M;
Tsochatzis, EA;
(2020)
Defining the minimum acceptable diagnostic accuracy of non-invasive fibrosis testing in cirrhosis: a decision analytic modelling study.
Hepatology
, 71
(2)
pp. 627-642.
10.1002/hep.30846.
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Abstract
No studies explore the clinical consequences of using non‐invasive tests (NITs) compared to liver biopsy (LB) in diagnosing cirrhosis. Our aim was to combine two decision analytic models to determine the minimum diagnostic accuracy criteria for NITs to diagnose cirrhosis with equivalence to LB in terms of mortality. We further evaluated selected existing NITs used alone and sequentially. A decision tree was constructed with associated 2‐year mortality incorporating a LB or NIT strategy to diagnose cirrhosis in a hypothetical cohort of 1000 asymptomatic patients. Cirrhosis prevalence was modelled at 5%, 20% and 50%. Decision curve analyses were performed, expressing the net benefit of tests over a range of threshold probabilities (Pt). The NIT deriving from the two models that could diagnose cirrhosis with at least equal mortality to LB was termed mNIT. Existing NITs were then compared using both decision models. The combined mNIT minimum sensitivity and specificity to diagnose cirrhosis with equivalence to LB at 5%, 20% and 50% cirrhosis prevalence were; 89% and 88%, 94% and 85%, and 94% and 87%, respectively at Pt=0.20. Sequential NITs performed better than single NITs at any prevalence. Combining both decision models, FibroTest® plus VCTE (vibration controlled transient elastography) and VCTE alone were the only existing NITs that were better or equal to LB at diagnosing cirrhosis at 5% prevalence. At 20% and 50% prevalence, only FibroTest® high specificity cut‐off plus VCTE was equivalent or better than LB.
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