Hallauer 06/2001 1

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

Hallauer 06/2001 2

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 surveillance

Incidence 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 typeof 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)

Year

1988 1990 1992 1994 1996 1998 0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Rep

ort

ed

Cases ??????

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

Year

1988 1990 1992 1994 1996 1998 0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Rep

ort

ed

Cases Change in case

definition of AIDS diagnosis

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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 (>2.5 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 surveillance

Systems 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

PopulationHospital-basedOutpatient clinicSchool-basedCommunity/HouseholdBlood donorsPregnant womenMilitary

Difficulty +

+++++

++++

+++

Expense+

++ +++++++

+++

Representativ

e+/- ++ +++

++++

+/-+++++

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Sources for Serologic DataHistoric 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