1. Hallauer 06/20011 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

2. Hallauer 06/20012 Outcome evaluation of an universal hepatitis B immunisation programme Acute disease surveillance Sero-surveys Immunisation coverage surveys Monitor adverse events Quality control

3. Hallauer 06/20013 Acute disease surveillance Incidence of acute hepatitis B Mandatory notification Laboratory notification Sentinel system Hospital reporting Death registry

4. Hallauer 06/20014 Surveillance for Acute Viral Hepatitis Case Definition Clinical CriteriaLaboratory Criteria Differs for each type of acute viral hepatitis Same for all types of acute viral hepatitis

5. Hallauer 06/20015 Reported Cases of AIDS in the United States (1987-1998) Year 198819901992199419961998 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 Reported Cases ??????

6. Hallauer 06/20016 Reported Cases of AIDS in the United States (1987-1998) Year 198819901992199419961998 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 Reported Cases Change in case definition of AIDS diagnosis

7. Hallauer 06/20017 Acute disease surveillance Case 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

8. Hallauer 06/20018 Acute disease surveillance Systems in selected countries (Viral Hepatitis Vol 5 no 3)

9. Hallauer 06/20019 Acute disease surveillance report 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

10. Hallauer 06/200110 Sero-surveys HBsAg-prevalence and hepatitis B markers Serological surveillance of parts of the population Screening of blood donors Screening of pregnant women Screening of Military personnel

11. Hallauer 06/200111 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 +/- ++ +++ ++++ +/- +++ ++

12. Hallauer 06/200112 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

13. Hallauer 06/200113 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

14. Hallauer 06/200114 Immunisation coverage surveys Immunisation coverage = number of vaccinees in the target population size of the target population

15. Hallauer 06/200115 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

16. Hallauer 06/200116 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

17. Hallauer 06/200117 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

18. Hallauer 06/200118 Quality control Parameters 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