Quality standard
Quality statement 7: 6-monthly surveillance testing for hepatocellular carcinoma in adults with chronic hepatitis B infection who have significant liver fibrosis or cirrhosis
Quality statement 7: 6-monthly surveillance testing for hepatocellular carcinoma in adults with chronic hepatitis B infection who have significant liver fibrosis or cirrhosis
Quality statement
Adults with chronic hepatitis B infection who have significant liver fibrosis or cirrhosis are offered 6-monthly surveillance testing for hepatocellular carcinoma.
Rationale
Significant liver fibrosis or cirrhosis is a substantial risk factor for hepatocellular carcinoma, and people with chronic hepatitis B infection who develop liver damage are at increased risk. This form of cancer develops quickly and may be asymptomatic until it is advanced. Regular surveillance testing at 6-month intervals helps to ensure that hepatocellular carcinoma is detected early, which can lead to earlier treatment and may improve the person's chances of survival.
Quality measures
The following measures can be used to assess the quality of care or service provision specified in the statement. They are examples of how the statement can be measured, and can be adapted and used flexibly.
Structure
Evidence of local arrangements to ensure that adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis are offered 6-monthly surveillance testing for hepatocellular carcinoma.
Data source: No routinely collected national data for this measure has been identified. Data can be collected from information recorded locally by provider organisations, for example from service pathways or protocols.
Process
Proportion of adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis who receive 6-monthly surveillance testing for hepatocellular carcinoma.
Numerator – the number in the denominator who received their most recent hepatocellular carcinoma surveillance testing within 6 months of their previous test or within 6 months of having significant liver fibrosis or cirrhosis identified.
Denominator – the number of adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis.
Data source: No routinely collected national data for this measure has been identified. Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.
Outcome
Stage of hepatocellular carcinoma at diagnosis for adults with chronic hepatitis B infection.
Data source: No routinely collected national data for this measure has been identified. Data can be collected from information recorded locally by healthcare professionals and provider organisations, for example from patient records.
What the quality statement means for different audiences
Service providers (hospital-based specialist care providers) ensure that competent healthcare professionals are in place to meet the commissioned levels of activity through outpatient clinics and may demonstrate outcomes to commissioners by monitoring the stage of hepatocellular carcinoma at diagnosis for adults with chronic hepatitis B infection.
Healthcare professionals offer adults with chronic hepatitis B infection and significant liver fibrosis or cirrhosis 6-monthly surveillance testing for hepatocellular carcinoma.
Commissioners (clinical commissioning groups) ensure that hospital-based specialist care providers have systems and facilities in place to provide 6‑monthly surveillance testing for hepatocellular carcinoma for adults with chronic hepatitis B and significant liver fibrosis or cirrhosis. For more information on surveillance testing see NICE's guideline on hepatitis B (chronic), section 1.7.
Adults with chronic hepatitis B infection (infection that has lasted for 6 months or more) and severe scarring of the liver (called fibrosis or cirrhosis) are offered an ultrasound scan and a blood test every 6 months to check for liver cancer.
Source guidance
Hepatitis B (chronic): diagnosis and management. NICE guideline CG165 (2013, updated 2017), recommendation 1.7.1
Definitions of terms used in this quality statement
Chronic hepatitis B
Chronic hepatitis B infection is defined as persistence of hepatitis B surface antigen (HBsAg) for 6 months or more after acute infection with hepatitis B virus. Chronic hepatitis B infection can be divided into e antigen (HBeAg)-positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity. [NICE's guideline on hepatitis B (chronic)]
Significant liver fibrosis or cirrhosis
Fibrosis is a progressive form of liver disease that can be caused by hepatitis B infection. Damage to liver cells results in scarring that prevents the liver from working normally. Significant fibrosis is determined by histological assessment and semi-quantitative scoring systems (METAVIR and Ishak score). Significant fibrosis is METAVIR stage F2 or higher, or Ishak stage 3 or higher. Cirrhosis occurs when liver inflammation and fibrosis spread to disrupt the shape and function of the liver. Even with no signs or symptoms of liver disease, the working capacity of liver cells has been badly impaired and they are unable to repair the liver. This is permanent cell damage and can lead to liver failure or liver cancer. [Adapted from NICE's full guideline on hepatitis B (chronic)]
Hepatocellular carcinoma
People with cirrhosis of the liver are at a small but significantly increased risk of developing a type of liver cancer called hepatocellular carcinoma. [NHS website, accessed June 2014]
Surveillance testing
The 6‑monthly surveillance testing for hepatocellular carcinoma is carried out by hepatic ultrasound and alpha-fetoprotein testing. [NICE's guideline on hepatitis B (chronic), recommendation 1.7.1]