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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

Authors

David J. Harman

Stephen D. Ryder

Martin W. James

Matthew Jelpke

Dominic S. Ottey

Emilie A. Wilkes

Dr TIM CARD tim.card@nottingham.ac.uk
Clinical Associate Professor

Guruprasad P. Aithal

NEIL GUHA neil.guha@nottingham.ac.uk
Professor of Hepatology



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.

Journal Article Type Article
Publication Date May 3, 2015
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 5
Issue 4
Article Number e007516
APA6 Citation Harman, D. J., Ryder, S. D., James, M. W., Jelpke, M., Ottey, D. S., Wilkes, E. A., …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), doi:10.1136/bmjopen-2014-007516
DOI https://doi.org/10.1136/bmjopen-2014-007516
Publisher URL http://bmjopen.bmj.com/content/5/4/e007516
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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