Highlights
- •The detection of patients with early cirrhosis is important to improve prognosis.
- •The SEAL algorithm evaluates the utility of population-based screening to detect cirrhosis as early as possible.
- •Excluding patients with decompensated cirrhosis at initial diagnosis, SEAL was associated with a 60% higher chance of early cirrhosis detection.
- •Only 50% of the patients identified by SEAL in primary care utilized specialist assessment.
Background & Aims
Detection of patients with early cirrhosis is of importance to prevent the occurrence
of complications and improve prognosis. The SEAL program aimed at evaluating the usefulness
of a structured screening procedure to detect cirrhosis as early as possible.
Methods
SEAL was a prospective cohort study with a control cohort from routine care data.
Individuals participating in the general German health check-up after the age of 35
(“Check-up 35”) at their primary care physicians were offered a questionnaire, liver
function tests (aspartate and alanine aminotransferase [AST and ALT]), and follow-up.
If AST/ALT levels were elevated, the AST-to-platelet ratio index (APRI) score was
calculated, and patients with a score >0.5 were referred to a liver expert in secondary
and/or tertiary care.
Results
A total of 11,859 participants were enrolled and available for final analysis. The
control group comprised 349,570 participants of the regular Check-up 35. SEAL detected
488 individuals with elevated APRI scores (4.12%) and 45 incident cases of advanced
fibrosis/cirrhosis. The standardized incidence of advanced fibrosis/cirrhosis in the
screening program was slightly higher than in controls (3.83‰ vs. 3.36‰). The comparison of the chance of fibrosis/cirrhosis diagnosis in SEAL vs. in standard care was inconclusive (marginal odds ratio 1.141, one-sided 95% CI 0.801, +Inf).
Of note, when patients with decompensated cirrhosis at initial diagnosis were excluded
from both cohorts in a post hoc analysis, SEAL was associated with a 59% higher chance of early cirrhosis detection
on average than routine care (marginal odds ratio 1.590, one-sided 95% CI 1.080, +Inf;
SEAL 3.51‰, controls: 2.21‰).
Conclusions
The implementation of a structured screening program may increase the early detection
rate of cirrhosis in the general population. In this context, the SEAL pathway represents
a feasible and potentially cost-effective screening program.
Registration
DRKS00013460
Lay summary
Detection of patients with early liver cirrhosis is of importance to prevent the occurrence
of complications and improve prognosis. This study demonstrates that the implementation
of a structured screening program using easily obtainable measures of liver function
may increase the early detection rate of cirrhosis in the general population. In this
context, the ‘SEAL’ pathway represents a feasible and potentially cost-effective screening
program.
Graphical abstract
Graphical Abstract
Keywords
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Article info
Publication history
Published online: April 22, 2022
Accepted:
April 11,
2022
Received in revised form:
April 8,
2022
Received:
January 31,
2022
Footnotes
Author names in bold designate shared co-first authorship
Identification
Copyright
© 2022 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
