Date of Defense:
July 28, 2015
Intro: Hepatitis B virus (HBV) infection, the most common form of chronic hepatitis worldwide, is a major public health problem affecting an estimated 240 million people globally. Vertical transmission of Hepatitis B virus is the predominant route of transmission for hepatitis endemic areas because of its transmission efficiency (Hou et al. 2005). According to the CDC, in the United States about 40% of babies born to hepatitis B positive mother become infected with the virus in absence of post – exposure prophylaxis and are at risk of developing HBV – related complications, such as cirrhosis and hepatic carcinoma. Perinatal transmission of hepatitis B can be reduced by early identification, routine monitoring of hepatitis B virus (HBV) carrier mothers, and treatment of infants born to HBV – infected women. Currently, major public health organizations such as, CDC and the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP) recommend that all pregnant women receive prenatal testing for hepatitis B during each pregnancy by screening serum for the presence of HBsAg, regardless of risk factors or immunization history.
Research Objective: Through surveillance data at the Minnesota Department of Health, the Perinatal Hepatitis B Prevention Program is able to follow all reported pregnancies to HBV infected women and recommend timely screening and treatment, if needed, during pregnancy, and timely screening and treatment for the babies in our program. In the past the Perinatal Hepatitis Program at MDH has met, and exceeded, all goals set nationwide by the CDC, and is one of the high performing programs around the country. It has reached a 98% post exposure prophylaxis rate among the reported pregnancies. The Office of Vital Records also collects hepatitis B related, among many other, in formation in the Birth Records. This information includes for the mother’s side – hepatitis B status of the mother and HBsAg lab test results – and for the infant’s side – timing and administration of birth dose, and HBIG. The birth record database can be used for different purposes. It can be used for a) policy making, that is, to form the basis for policy guidance, planning and projections; (b) for administration, that is, to monitor current demographic trends and action programmes; and (c) for research, that is, to support the scientific study of the interrelationship between fertility and mortality trends and socio – economic development. Therefore it is crucial to look at the validity and reliability of the information collected in the Birth Records, including hepatitis B related information. That is the focus of the project. We will use the Perinatal Hepatitis Prevention Database as our highest standard.
Method: A previously merged and de-identified dataset from Birth Record dataset and Perinatal HBV data set was used in this analysis. The merging occurred by obtaining a dataset containing all births in 2013 from Birth Records and matching that dataset to all women who were followed by the Perinatal Hepatitis B program due to positive HBV status/lab reports . The final dataset used in this project included women with confirmed or probable HBV status that gave birth in 2013. All the women were between the ages of 14 – 46. Overall percent agreement analysis was performed comparing information within the Birth Records dataset and comparing the HBV status information in the Birth Records dataset to the Perinatal HBV dataset. Final analysis also incorporated infants’ birth dose administration, or lack thereof, to better understand knowledge of provider regarding HBV status of the women. For all the analysis SAS software of utilized, and p – values were calculated using the McNemar’s Test.
Results: Overall, the Birth Record dataset correctly identified 361 of 430 individuals with their accurate HBV infection status. How ever, there are a significant number of people who were reported with inaccurate or missing information in the Birth Records. Findings included the presence of inconsistence/unreliable information within the Birth Records dataset (such as HBsAg – negative an d Infection the HBV – Yes) and presence of inaccurate information on HBV infection in the Birth Record compared to the Perinatal Hepatitis B data set, which is the gold standard. Roughly about 16% (out of 430) of the women had an “unknown” HBV infection stat us. For the 361 women that were correctly identified to be infected with HBV, 47 of them had negative and 3 of them had missing HBsAG lab test result. All the tables above that that compared the two datasets demonstrate that there is misreporting and conflicting information in the Birth Records dataset.
Conclusion: Even though there was a significant level of misreporting on the Birth Records, the Perinatal Hepatitis B Program has looked into all babies born to the women in this data set and all babies received both the birth dose and HBIG. Therefore, the HBV statuses of all the women were known prior to pregnancy, during pregnancy or during childbirth. However, there was a failure in retesting, communicating, and/or reporting the lab tests used to diagnose the women. The error/misreporting that was noted in birth certificate warrants attention from the birth facilities, Office of Vital Records, the CDC, and other public health professionals who use these data for studies, monitoring and/or surveillance.