Real-world evidence on non-invasive tests and associated cut-offs used to assess fibrosis in routine clinical practice
Citation
Lazarus, J. V., Castera, L., Mark, H. E., Allen, A. M., Adams, L. A., Anstee, Q. M., Arrese, M., Alqahtani, S. A., Bugianesi, E., Colombo, M., Cusi, K., Hagström, H., Loomba, R., Romero-Gómez, M., Schattenberg, J. M., Thiele, M., Valenti, L., Wong, V. W., Yilmaz, Y., Younossi, Z. M., … Tsochatzis, E. A. (2022). Real-world evidence on non-invasive tests and associated cut-offs used to assess fibrosis in routine clinical practice. JHEP reports : innovation in hepatology, 5(1), 100596. https://doi.org/10.1016/j.jhepr.2022.100596Abstract
Background & Aims: Non-invasive tests (NITs) offer a practical solution for advanced fibrosis identification in non-alcoholic
fatty liver disease (NAFLD). Despite increasing implementation, their use is not standardised, which can lead to inconsistent
interpretation and risk stratification. We aimed to assess the types of NITs and the corresponding cut-offs used in a range of
healthcare settings.
Methods: A survey was distributed to a convenience sample of liver health experts who participated in a global NAFLD
consensus statement. Respondents provided information on the NITs used in their clinic with the corresponding cut-offs and
those used in established care pathways in their areas.
Results: There were 35 respondents from 24 countries, 89% of whom practised in tertiary level settings. A total of 14 different
NITs were used, and each respondent reported using at least one (median = 3). Of the respondents, 80% reported using FIB-4
and liver stiffness by vibration-controlled transient elastography (Fibroscan®), followed by the NAFLD fibrosis score (49%). For
FIB-4, 71% of respondents used a low cut-off of <1.3 (range <1.0 to <1.45) and 21% reported using age-specific cut-offs. For
Fibroscan®, 21% of respondents used a single liver stiffness cut-off: 8 kPa in 50%, while the rest used 7.2 kPa, 7.8 kPa and
8.7 kPa. Among the 63% of respondents who used lower and upper liver stiffness cut-offs, there were variations in both values
(<5 to <10 kPa and >7.5 to >20 kPa, respectively). Conclusions: The cut-offs used for the same NITs for NAFLD risk stratification vary between clinicians. As cut-offs impact test
performance, these findings underscore the heterogeneity in risk-assessment and support the importance of establishing
consistent guidelines on the standardised use of NITs in NAFLD management.
Lay summary: Owing to the high prevalence of non-alcoholic fatty liver disease (NAFLD) in the general population it is
important to identify those who have more advanced stages of liver fibrosis, so that they can be properly treated. Noninvasive tests (NITs) provide a practical way to assess fibrosis risk in patients. However, we found that the cut-offs used
for the same NITs vary between clinicians. As cut-offs impact test performance, these findings highlight the importance of
establishing consistent guidelines on the standardised use of NITs to optimise clinical management of NAFLD.
