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

Harman, David J.; Ryder, Stephen D.; James, Martin W.; Jelpke, Matthew; Ottey, Dominic S.; Wilkes, Emilie A.; Card, Timothy R.; Aithal, Guruprasad P.; Guha, Indra Neil

Abstract

OBJECTIVES: To assess the feasibility of a novel diagnostic algorithm targeting patients with risk factors for chronic liver disease in a community setting.

DESIGN: Prospective cross-sectional study.

SETTING: Two primary care practices (adult patient population 10 479) in Nottingham, UK.

PARTICIPANTS: Adult 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.

INTERVENTIONS: A 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 MEASURES: Diagnosis of clinically significant liver disease (defined as liver stiffness ≥8 kPa); definitive diagnosis of liver cirrhosis.

RESULTS: We 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.

CONCLUSIONS: A 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 NUMBER: The diagnostic algorithm utilised for this study can be found on clinicaltrials.gov (NCT02037867), and is part of a continuing longitudinal cohort study.

Citation

Harman, D. J., Ryder, S. D., James, M. W., Jelpke, M., Ottey, D. S., Wilkes, E. A., Card, T. R., Aithal, G. P., & Guha, I. N. (2015). Direct targeting of risk factors significantly increases the detection of liver cirrhosis in primary care: a cross-sectional diagnostic study utilising transient elastography. BMJ Open, 5(4), Article e007516. https://doi.org/10.1136/bmjopen-2014-007516

• Journal Article Type: Article
• Publication Date: May 3, 2015
• Deposit Date: Mar 21, 2016
• Publicly Available Date: Mar 21, 2016
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 5
• Issue: 4
• Article Number: e007516
• DOI: https://doi.org/10.1136/bmjopen-2014-007516
• Public URL: https://nottingham-repository.worktribe.com/output/752782
• Publisher URL: http://bmjopen.bmj.com/content/5/4/e007516