Professional Statements and Societal Positions Guidelines
Practice Guidelines and Position Statements
Nonalcoholic Fatty Liver Disease
American Gastroenterological Association et al
The practice guidelines on the diagnosis and management of NAFLD, developed by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, and the American College of Gastroenterology (2018) stated that “NFS [NAFLD fibrosis score] or FIB-4 [Fibrosis-4] index are clinically useful tools for identifying NAFLD individuals with higher likelihood of having bridging fibrosis (stage 3) or cirrhosis (stage 4).” It also cited VCTE [vibration-controlled transient elastography] and MRE [magnetic resonance elastography] as “clinically useful tools for identifying advanced fibrosis in individuals with NAFLD.”
National Institute for Health and Care Excellence
The NICE (2016) published guidance on the assessment and management of NAFLD. The guidance did not reference elastography. The guidance recommended the enhanced liver fibrosis test to test for advanced liver fibrosis, utilizing a cut-off enhanced liver fibrosis score of 10.51.
American Gastroenterological Association Institute
The American Gastroenterological Association Institute (2017) published guidelines on the role of elastography in chronic liver disease. The guidelines indicated that, in adults with NAFLD, VCTE has superior diagnostic sensitivity and specificity for diagnosing cirrhosis than the APRI or FIB-4 tests (very low quality of evidence). Moreover, the guidelines stated that, in adults with NAFLD, magnetic resonance-guided elastography has little or no increased diagnostic accuracy for identifying cirrhosis compared with VCTE in individuals who have cirrhosis, and has higher diagnostic accuracy than VCTE in individuals who do not have cirrhosis (very low quality of evidence).
Hepatitis B and C Viruses
National Institute for Health and Care Excellence
The NICE (2013) published guidance on the management and treatment of individuals with hepatitis B. The guidance recommended offering transient elastography as the initial test in adults diagnosed with chronic hepatitis B, to inform the antiviral treatment decision.
Antiviral Treatment Recommendations by Transient Elasticity Score
Transient Elasticity Score
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Antiviral Treatment
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>11 kPa
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Offer antiviral treatment
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6-10 kPa
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Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment
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<6 kPa plus abnormal (ALT)
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Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment
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<6 plus normal ALT
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Do not offer antiviral treatment
|
ALT: alanine aminotransferase; kPa: kilopascal.
As of September 2016, the NICE had placed a pause on the development of the guidance on hepatitis C, citing instability and costs in the availability of treatments for the condition.
American Association for the Study of Liver Diseases and Infectious Diseases Society of America
The American Association for the Study of Liver Diseases and Infectious Diseases Society of America (2018) guidelines for testing, managing, and treating hepatitis C virus (HCV) recommended that, for counseling and pretreatment assessment purposes, the following should be completed:
“Evaluation for advanced fibrosis using liver biopsy, imaging, and/or noninvasive markers is recommended in all persons with HCV infection to facilitate an appropriate decision regarding HCV treatment strategy and determine the need for initiating additional measures for the management of cirrhosis (e.g., hepatocellular carcinoma screening).
Rating: Class I, Level A [evidence and/or general agreement; data derived from multiple randomized trials, or meta-analyses]”
The guidelines noted that there are several noninvasive tests to stage the degree of fibrosis in individuals with HCV. Tests included indirect serum biomarkers, direct serum biomarkers, and VCTE. The guidelines asserted that no single method is recognized to have high accuracy alone and careful interpretation of these tests is required.
American Gastroenterological Association Institute
Guidelines published by the American College of Gastroenterology Institute (2017) on the role of elastography in chronic liver disease indicated that, in adults with chronic hepatitis B virus and chronic HCV, VCTE has superior diagnostic performance for diagnosing cirrhosis than the APRI and FIB-4 tests (moderate quality of evidence for HCV, low quality of evidence for hepatitis B virus). In addition, the guidelines stated that, in adults with HCV, magnetic resonance-guided elastography has little or no increased diagnostic accuracy for identifying cirrhosis compared with VCTE in individuals who have cirrhosis, and has lower diagnostic accuracy than VCTE in individuals who do not have cirrhosis (very low quality of evidence).
Chronic Liver Disease
American College of Radiology
The American College of Radiology (2017) appropriateness criteria rated 1-dimensional transient elastography as a 7 (usually appropriate) for the diagnosis of liver fibrosis in individuals with chronic liver disease. The criteria noted, “This procedure is less reliable in diagnosing liver fibrosis and cirrhosis in individuals with obesity or ascites.”
European Association for the Study of Liver Disease et al
The European Association for the Study of Liver Disease and the Asociacion Latinoamericana para el Estudio del Higado (2015) convened a panel of experts to develop clinical practice guidelines on the use of noninvasive tests to evaluate liver disease severity and prognosis. The publication summarized the advantages and disadvantages of noninvasive techniques (serum biomarkers, imaging techniques). Table 9 summarized the joint recommendations for serum biomarkers and transient elastography.
Table 9. Recommendations for Serum Biomarkers and Transient Elastography
Biomarkers
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QOE
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SOR
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“Serum biomarkers can be used in clinical practice due to high applicability (>95%) and good reproducibility.”
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High
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Strong
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“TE can be considered the non-invasive standard for the measure of LS”
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High
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Strong
|
“Serum biomarkers are well-validated for chronic viral hepatitis…. They are less well-validated for NAFLD not validated in other chronic kidney diseases.”
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High
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Strong
|
"For the diagnosis of significant fibrosis a combination of tests with concordance may provide the highest diagnostic accuracy”
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High
|
Weak
|
“All HCV individuals should be screened to exclude cirrhosis by TE [or]… serum biomarkers.…”
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High
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Strong
|
“Non-invasive assessment including serum biomarkers or TE can be used as first-line procedure for the identification of individuals at low risk of severe fibrosis/cirrhosis”
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High
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Strong
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“Follow-up assessment by either serum biomarkers or TE for progression of liver fibrosis should be used for NAFLD individuals at a 3-year interval”
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Moderate
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Strong
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HCV: hepatitis C virus; LS: liver stiffness; NAFLD: nonalcoholic fatty liver disease; QOE: quality of evidence; SOR: strength of recommendation; TE: transient elastography.
