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Non-Invasive Diagnostic Assessment Tools for the Detection of Liver Fibrosis in Patients with Suspected Alcohol-Related Liver Disease: A Systematic Review and Economic Evaluation
Health Technology Assessment, No. 16.4
M Stevenson, M Lloyd-Jones, MY Morgan, and R Wong.
Author Information and AffiliationsSouthampton (UK): NIHR Journals Library; 2012 Feb.
Abstract
Background:
Excessive alcohol consumption may lead to the development of alcoholrelated liver disease (ALD). Liver biopsy may be used in patients with suspected ALD to confirm the diagnosis, exclude other or additional liver pathologies, and provide accurate staging of the degree of liver injury in order to enable the prediction of prognosis and inform treatment decisions. However, as it is an invasive procedure that carries the risk of morbidity and mortality, current UK guidance recommends that biopsy is not required to confirm the diagnosis in patients with a high clinical suspicion of ALD in whom blood tests have excluded other causes of liver disease, unless it is necessary to confirm a diagnosis of acute alcoholic hepatitis in order to inform specific treatment decisions.
Objectives:
To evaluate the diagnostic accuracy, cost-effectiveness, and effect on patient outcomes of four non-invasive tests for liver fibrosis [the Enhanced Liver Fibrosis (ELF™) test (Siemens Healthcare Diagnostic Inc., Tarrytown, NY, USA), FibroTest (BioPredictive, Paris, France), FibroMAX (BioPredictive, Paris, France) and transient elastography (FibroScan®; produced by EchoSens, Paris, France and distributed in the UK by Artemis Medical Ltd, Kent, UK)] in patients suspected of having ALD.
Data sources:
A systematic review was undertaken to identify studies reporting the diagnostic and prognostic accuracy of the ELF test, FibroTest, FibroMAX, and FibroScan for the identification of liver fibrosis and associated conditions in patients with suspected ALD. The following databases were searched in January 2010: MEDLINE (from 1950 to January 2010), MEDLINE In-Process & Other Non-Indexed Citations (from 1950 to January 2010), EMBASE (from 1980 to January 2010), Cochrane Database of Systematic Reviews (from 1996 to January 2010), Cochrane Central Register of Controlled Trials (from 1898 to January 2010), Cochrane Methodology Register (from 1904 to January 2010), Database of Abstracts of Reviews of Effects (from 1995 to January 2010), HTA Database (from 1995 to January 2010), NHS Economic Evaluation Database (from 1995 to January 2010), Cumulative Index to Nursing and Allied Health Literature (from 1982 to January 2010), Web of Knowledge and Science Citation Index (from 1969 to January 2010).
Review methods:
Study quality was assessed using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist. Owing to the heterogeneity of the studies, no formal meta-analysis was undertaken. A de novo mathematical model was constructed to estimate the incremental costs and incremental quality-adjusted life-years (QALYs) associated with alternative strategies compared with a biopsy-all strategy. The tests are assessed first as a replacement for liver biopsy, and secondly as an additional test prior to liver biopsy. Thirty-six scenarios were assessed for each non-invasive test strategy, which varied the sensitivity of biopsy, the anxiety associated with biopsy, sensitivity and specificity values and whether or not the biopsy was percutaneous or transjugular. For each scenario, threshold levels were reported where biopsying all patients was more cost-effective than the strategy for two parameters (the decreased level of abstinence associated with the strategy compared with biopsying all and the level of incidental QALY gain associated with biopsy).
Results:
No studies were identified that specifically assessed the ELF test, although a study was identified that evaluated the diagnostic accuracy of the European Liver Fibrosis Test (essentially, the ELF test with the addition of age to the algorithm) compared with biopsy. Three studies of FibroTest, no relevant studies of FibroMax, and six studies of FibroScan assessing accuracy compared with biopsy in patients with known or suspected alcohol-related liver disease were identified. In all studies, the number of patients with suspected ALD was small, meaning that the estimated sensitivities and specificities were not robust. No conclusive estimate of the cost per QALY of each non-invasive test could be provided. Scenarios exist in which each of the strategies analysed is more cost-effective than biopsying all patients and, in contrast, scenarios exist in which each strategy is less cost-effective than biopsying all patients.
Limitations:
Study selection and data analysis were undertaken by one reviewer.
Conclusions:
No conclusive result can be provided on the most cost-effective strategy until further data are available. A large number of parameters require data; however, the following are selected as being of most importance: (1) the sensitivity and specificity of each non-invasive liver test (NILT) against biopsy at validated and pre-selected cut-off thresholds; (2) the influence of potential confounding variables such as current drinking behaviour and the degree of hepatic inflammation on the performance of NILTs; and (3) the likelihood, and magnitude, of decreases in abstinence rates associated with a diagnosis of significant ALD by diagnostic modality and the incidental gains in QALYs that may be associated with biopsy.
Funding:
The National Institute for Health Research Technology Assessment programme.
Contents
- NIHR Health Technology Assessment programme
- Glossary
- List of abbreviations
- Executive summary
- 1. Background
- 2. Definition of the decision problem
- 3. Cost-effectiveness: model structure and methodology
- 4. Assessment of clinical effectiveness
- 5. Cost-effectiveness: model parameters
- Discount rates
- The sensitivity and specificity of non-invasive liver tests used within the economic model
- The prevalence of cirrhosis in the defined population
- The costs of biopsy and each non-invasive liver test
- Adverse events related to each diagnostic test
- The proportion of tests that will produce results that cannot be used
- The outcomes associated with each final node within the economic model for diagnosis of cirrhosis
- The proportion of patients without cirrhosis who continue to drink heavily that will develop cirrhosis
- The benefit of biopsy in identifying liver disease that is not alcohol-related liver disease and confirming alcohol-related liver disease
- 6. Cost-effectiveness model: results
- 7. Discussion
- Acknowledgements
- References
- Appendix 1 Categorisation of disease progression as identified by liver biopsy
- Appendix 2 The Alcohol Use Disorders Identification Test
- Appendix 3 Liver biopsy: systematic review of adverse events
- Appendix 4 Systematic review of the adverse effects of liver biopsy: search strategies
- Appendix 5 Assessment of clinical effectiveness and cost-effectiveness, adverse effects, and quality of life: search strategies
- Appendix 6 QUADAS: details of criteria for scoring studies
- Appendix 7 Excluded studies
- Appendix 8 Diagnostic venepuncture: systematic review of adverse events
- Appendix 9 Systematic review of the adverse effects of venepuncture: search strategies
- Appendix 10 The results from the cost-effectiveness analyses
- Appendix 11 Project protocol
- Health Technology Assessment programme
Suggested citation:
Stevenson M, Lloyd-Jones M, Morgan MY, Wong R. Non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol-related liver disease: a systematic review and economic evaluation. Health Technol Assess 2012;16(4).
Declared competing interests of the authors: none
The research reported in this issue of the journal was commissioned by the HTA programme as project number 09/62/01. The contractual start date was in December 2009. The draft report began editorial review in July 2010 and was accepted for publication in March 2011. As the funder, by devising a commissioning brief, the HTA programme specified the research question and study design. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the referees for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
The views expressed in this publication are those of the authors and not necessarily those of the HTA programme or the Department of Health.
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