Direct targeting of risk factors significantly increases the detection of liver cirrhosis in primary care: a cross-sectional diagnostic study utilising transient elastography

Abstract

ObjectivesTo assess the feasibility of a novel diagnostic algorithm targeting patients with risk factors for chronic liver disease in a community setting.DesignProspective cross-sectional study.SettingTwo primary care practices (adult patient population 10 479) in Nottingham, UK.ParticipantsAdult patients (aged 18 years or over) fulfilling one or more selected risk factors for developing chronic liver disease: (1) hazardous alcohol use, (2) type 2 diabetes or (3) persistently elevated alanine aminotransferase (ALT) liver function enzyme with negative serology.InterventionsA serial biomarker algorithm, using a simple blood-based marker (aspartate aminotransferase:ALT ratio for hazardous alcohol users, BARD score for other risk groups) and subsequently liver stiffness measurement using transient elastography (TE).Main outcome measuresDiagnosis of clinically significant liver disease (defined as liver stiffness ≥8 kPa); definitive diagnosis of liver cirrhosis.ResultsWe identified 920 patients with the defined risk factors of whom 504 patients agreed to undergo investigation. A normal blood biomarker was found in 62 patients (12.3%) who required no further investigation. Subsequently, 378 patients agreed to undergo TE, of whom 98 (26.8% of valid scans) had elevated liver stiffness. Importantly, 71/98 (72.4%) patients with elevated liver stiffness had normal liver enzymes and would be missed by traditional investigation algorithms. We identified 11 new patients with definite cirrhosis, representing a 140% increase in the number of diagnosed cases in this population.ConclusionsA non-invasive liver investigation algorithm based in a community setting is feasible to implement. Targeting risk factors using a non-invasive biomarker approach identified a substantial number of patients with previously undetected cirrhosis.Trial registration numberThe diagnostic algorithm utilised for this study can be found on clinicaltrials.gov (NCT02037867), and is part of a continuing longitudinal cohort study.

Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review

“…In the three studies (19,28,29) which utilised TE the reported disease prevalence was similar despite two different thresholds being chosen and the reported outcome measures being different.…”

“…Harman et al (29) was the only study which reported the percentage of patients with a normal ALT level who were diagnosed with cirrhosis. In this study 90.9% of patients with asymptomatic compensated cirrhosis would not have been identified via traditional community based algorithms.…”

Hepatic steatosis and fibrosis: Non-invasive assessment

“…Most interestingly, 71/98 patients (72.4%) of these patients had normal liver enzymes and would have been otherwise missed by conventional algorithm models. This techniques also managed to identify 140% more patients with definite cirrhosis ( n = 11)[123]. …”

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“…TE was offered to primary care patients with an AST:ALT ratio ≥ 0.8 [224]. However, This study did not include biopsy confirmation in patients with elevated TE.…”