Outcome evaluation of an universal hepatitis B immunisation programme

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Outcome evaluation of an universal hepatitis B
immunisation programme

• Johannes F. Hallauer M.D.
• Health Systems Research
• Charité, Humboldt University Berlin
• Susan Goldstein, M.D.
• Division of Viral Hepatitis
• Centers for Disease Control and Prevention, USA

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Outcome evaluation of an universal hepatitis B
immunisation programme

• Acute disease surveillance
• Sero-surveys
• Immunisation coverage surveys
• Monitor adverse events
• Quality control

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Acute disease surveillanceIncidence of acute
hepatitis B

• Mandatory notification
• Laboratory notification
• Sentinel system
• Hospital reporting
• Death registry

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Surveillance for Acute Viral Hepatitis
Case Definition
Clinical Criteria
Laboratory Criteria
Differs for each type of acute viral hepatitis
Same for all types of acute viral hepatitis
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Reported Cases of AIDS in the United States
(1987-1998)



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Reported Cases of AIDS in the United States
(1987-1998)



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Acute disease surveillanceCase definition of
hepatitis B

• A clinical case of acute viral hepatitis is an
  acute illness that includes the discrete onset of
  symptoms and jaundice or elevated serum
  aminotrans-ferase levels (gt2.5 times the upper
  limit of normal)
• A confirmed case of hepatitis B is a clinical
  case that is laboratory confirmed anti-HBc-IgM
  positive and anti-HAV-IgM negative.
• Patients not tested for IgM anti-HBc, but are
  HBsAg positive and negative for IgM anti-HAV are
  suspected cases of acute hepatitis B

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Acute disease surveillanceSystems in selected
countries(Viral Hepatitis Vol 5 no 3)
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Acute disease surveillancereport data sets may
include

• Patient demographics
• Specimen type
• Diagnosis
• Date
• Method of identification
• Lab name
• District and region

• Reason for testing
• Clinical features
• Relevant risk factors
• Occupational information
• Overseas travel
• Contact information

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Sero-surveysHBsAg-prevalence and hepatitis B
markers

• Serological surveillance of parts of the
  population
• Screening of blood donors
• Screening of pregnant women
• Screening of Military personnel

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Comparison of Various Populations as Sources of
Serologic Data
Population Hospital-based Outpatient
clinic School-based Community/ Household Blood
donors Pregnant women Military
Difficulty
Expense
Representative /- /-
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Sources for Serologic Data

• Historic data
• Published papers journals, medical school
  journals
• Unpublished papers theses
• Blood bank
• Special studies conducted by MOH, academic
  institutions
• Newly collected data
• Collected as immunization program commences
• Program should not be delayed to collect data

Similar population must be available for follow-up
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Surveillance of chronic consequences

• Morbidity and mortality data on cirrhosis
• Morbidity and mortality data on HCC
• Data on number of liver transplants
• Hospital discharge register

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Immunisation coverage surveys

• Immunisation coverage
• number of vaccinees in the target population
• size of the target population

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Immunisation coverage surveys

• Survey of immunisation certificates
• National survey at school entry
• Child health registry
• Vaccine sales figures
• Precription for vaccine doses
• Doses of imported or licensed vaccine
• Doses of distributed vaccine

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Monitor adverse events

• Monitoring systems which are already in place for
  tracking adverse events following immunization
  should be applied to hepatitis B immunization
  programmes as well
• There is no need for additional vertical
  monitoring programmes

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Monitoring adverse events programmes should
include

• Who reports adverse events
• Who is notified
• How information is verified
• What action and feedback are taken
• How causality is determined
• Compensation schemes
• Assesment of impact on vaccination programmes
• Legal ramifications

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Quality controlParameters for Programme
evaluation

• Which antigens to be monitored
• At what age vaccinees are evaluated
• Frequency and criteria of assessments
• Acceptability of data sources- validation
• Data collection and management by IT
• Confidentiality issues to be addressed
• Operative targets to be met