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OUTLINE - Background - Objectives - Methods - Results - Discussion/Limitations - Recommendation

Evaluation of Perinatal Hepatitis B Virus (pHBV) Infections Reported to the National Notifiable Disease Surveillance System (NNDSS) for Infants Born in 2005 _______________________________________

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OUTLINE - Background - Objectives - Methods - Results - Discussion/Limitations - Recommendation

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  1. Evaluation of Perinatal Hepatitis B Virus (pHBV) Infections Reported to the National Notifiable Disease Surveillance System (NNDSS) for Infants Born in 2005_______________________________________ Dana M. Roque, MD; Sandra W. Roush, MT/MPH; Lisa Jacques-Carroll, MSW; Annemarie Wasley, SciD; Susan Wang MD/MPH

  2. OUTLINE - Background - Objectives - Methods - Results - Discussion/Limitations - Recommendation

  3. BACKGROUND

  4. EPIDEMIOLOGY • • In 2005, ~24,000 infants were born to HBV-infected • mothers in the U.S. • •Without immunoprophylaxis • - 40% of infants born to HBV-infected mothers in the U.S. • will develop chronic HBV infection • - 25% of those with chronic infection may die prematurely • of liver cancer /cirrhosis

  5. PREVENTION OF pHBV •Post-exposure prophylaxis (PEP) - birth: hepatitis B immune globulin (HBIG) + HBV vaccine - childhood: completion of HBV vaccine series • PEP decreases vertical/horizontal transmission - vaccine alone: prevents 70-95% cases - vaccine + HBIG: prevents 85-95% cases

  6. PERINATAL HBV PREVENTION PROGRAM • • Composition: - established in 1990 • - 64 grantees (50 states, 6 cities, 8 territories) • - funded by CDC’s National Center for Immunization and Respiratory Diseases • • Goals: • - prevent HBV infections in at-risk infants through • case management • - identify pHBV infections that do occur

  7. ACTIVITIES OF THE pHBV PROGRAM identification of HBsAg+ women identification of at-risk infants HBIG + 3-4 doses of vaccine for at-risk infants post-vaccination testing Infected Infants Susceptible Infants

  8. REPORTING HBV-INFECTED INFANTS •Case definition - HBsAg-positive infant aged 1-24 months born to an HBsAg-positive mother in the U.S. or territories • Surveillance Mechanisms -Perinatal HBV Prevention Program (since 1996): - grantees report aggregate cases through the Perinatal Assessment - Immunization Program division -NNDSS (since 2002): - states report individual cases - Communicable Disease division

  9. PERINATAL ASSESSMENT: • KEY QUESTIONS • number of infants born to HBsAg-positive women who received • proper immunoprophylaxis/post-vaccination serologic testing and • were HBsAg-positive? • number of these infants believed to have been reported to NNDSS? • OTHER • number of live births to HBsAg-positive women? • - number of infants entered into the tracking system? • estimated percentage of women screened for HBsAg status? • is tracking system computerized?

  10. REPORTING HBV-INFECTED INFANTS Laboratories, Healthcare Providers, Other Sources Perinatal HBV Program (since 1996) Communicable Disease Division (since 2002) Perinatal Assessment NNDSS Aggregate Data Line-Listed Data Centers for Disease Control

  11. HISTORY OF REPORTED pHBV CASES *In Perinatal Assessment “year” represents the year of infant’s birth, in NNDSS “year” represents the year the case was reported

  12. OBJECTIVES • Identify pHBV infections captured by each database • Describe discrepancies between the databases •Formulate strategies to improve reporting accuracy and completeness • Examine the potential effect of case reconciliation on database concordance

  13. METHODS

  14. 1. Case identification from both databases • NNDSS • - perinatal HBV event code (10104) • - reporting period: January 1, 2005 to March 29, 2007 • Perinatal Assessment • - cases reported by grantees via Perinatal Assessment • - submitted by April 30, 2007 • - grantees reporting ≥ 1 case asked to provide additional • demographic information and NNDSS ID for case • verificationand comparison

  15. 2. Case reconciliation • Cases captured by these databases were “matched” • using DOB and/or NNDSS ID +/- gender or race • Perinatal Coordinators were made aware of discrepancies • between number of cases identified in the Perinatal • Assessment and those actually reported to NNDSS

  16. 3. Examination of reporting errors • classification • quantification • 4. Assessment of post-reconciliation database • concordance • NNDSS lines listings were re-examined in October 2007, • following the close of data entries for CY 2005

  17. RESULTS

  18. •There were discrepancies in the number of infants • captured by each database: • - Perinatal Assessment: n = 86 • - NNDSS: n = 61 • •There were errors and incompleteness of data: • FAILURES TO MEET CASE DEFINITION • - date of birth ≠ 2005 • - maternal infection miscoded as perinatal case and/or maternal DOB provided in place of infant DOB • - perinatal cases reported as chronic or acute hepatitis • - foreign-born • OTHER • - duplicate entry • - insufficient data: incomplete/incorrect reporting of critical variables preventing case verification • - false positive: retrospectively case found to submitted in error

  19. INFECTIONS REPORTED BY DATABASE Perinatal Assessment 2005 NNDSS (2005-2007) w/ DOB 2005 86 HBsAg- positive infants 61 reported cases 18 errors/ exclusions: 7 DOB ≠ 2005 4 false positives 7 insufficient data 14 errors/ exclusions: 1 foreign-born 9 mothers reported 3 insufficient data 1 duplicate 68 verified cases in database 11% (n=8) incorrect/ unreported race 1% (n=1) incorrect gender 47 verified cases in database 34% (n=16) unreported race 4% (n=2) unreported DOB* * Able to verify case by matching NNDSS ID to infant reported in Perinatal Assessment

  20. DATABASE CONCORDANCE: pre-reconciliation There were at least 73 unique cases across both databases, but only 42 (58%) captured by both 58% 35% 7% Perinatal Assessment NNDSS 26 42 5

  21. CHARACTERISTICS OF REPORTED INFANTS • Among infants captured by both databases, - GENDER: - 50% Male - 50% Female - RACE:- 85% Asian - 10% Unknown - 2.5% White - 2.5% Black •There were no statistically significant differences in demographic characteristics of such infants and those captured solely by NNDSS or the Perinatal Assessment

  22. REASONS INFANTS WERE NOT REPORTED TO NNDSS • perinatal cases mistakenly reported as acute/chronic cases or unaware of creation of perinatal category (n=3) • transmission “glitches” or oversights (n=5) • other technical difficulty (n= 16) • to be reported later in year (n=2)

  23. COMMUNICATION BETWEEN DIVISIONS •Perinatal Coordinators were asked to describe whether direct communication routinely occurs between the Perinatal Prevention Program and persons responsible for NNDSS data entry - Among grantees with discordances in databases, only 40-50% reported direct communication - Among grantees with no discordances in databases, roughly 90% reported direct communication

  24. DATABASE CONCORDANCE: post-reconciliation Post-reconciliation, there were 78* unique cases across both databases, 63 (81%) captured by both 81% 63 9% 7 10% 8 Annual Assessment NNDSS There were three new cases found exclusively in NNDSS upon post-reconciliation review. * Includes 2 cases originally excluded for lack of sufficient data to verify, now included in concordant category.

  25. DISCUSSION & LIMITATIONS

  26. LIMITATIONS • This evaluation did not include the states with zero reported cases of perinatal HBV (50% of all states) • Though changes in database concordance were observed following the reconciliation process, we cannot attribute changes in concordance to this intervention alone

  27. 1. Database concordance is likely to be affected by communication between divisions • concordance increased following the case reconciliation process - pre: 58% - post: 81% • pre-reconciliation concordance was greater among grantees that reported direct communication between divisions

  28. 2. Problems with quality and completeness exist within both databases • Perinatal Assessment: - cases are reported for the wrong calendar year • NNDSS: - case definitions are misinterpreted (e.g., maternal cases are reported as perinatal cases) - critical variables are omitted

  29. 3. The cumulative number of cases among the two reporting systems is vastly fewer than estimates predict •Conservative projections suggest that as many as 700- pHBV cases go unidentified each year •There is under-reporting of pHBV infections

  30. RECOMMENDATION • • Perinatal Prevention Program and Communicable • Disease staff should work together to ensure all pHBV • infections are reported to both the Perinatal Assessment • and NNDSS • • Accurate reporting of infections is needed to assess • progress toward the goal of elimination of HBV • transmission in the U.S.

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