1. Sean O’Leary Julie Duran Christina Nelson March 29, 2011
Risk Factors Associated with Non-Receipt of Hepatitis B Vaccine in the Newborn Nursery
Sean O’Leary
Julie Duran
Christina Nelson
March 29, 2011

2. Disclosure
No relevant financial disclosures

3. Background Burden of disease
43,000 new cases of hepatitis B in US annually
1 million chronically infected
2,000 to 4,000 deaths/year
Early vaccination can prevent infants of infected mothers from developing hepatitis B
Infants with perinatal acquisition of hepatitis B → more likely to develop chronic hepatitis B
Only 50% of births to women with hepatitis B are identified for management prior to infants’ discharge
MMWR Recomm Rep. 2005;54:1-31

4. Background
Birth dose of hepatitis B vaccine is an important “safety net” for infants whose mothers are not identified as having hepatitis B
Providers and hospitals may consider their populations as “low risk” for hepatitis B
Close to 30% of women ages in U.S. are foreign born, some from countries hyperendemic for hepatitis B

5. National Immunization Policy
Cornerstone of strategy to eliminate hepatitis B: universal infant vaccination starting with a birth dose prior to discharge
ACIP recommendation
All hospitals develop policies to prevent perinatal hepatitis B transmission
Administration of hepatitis B vaccine to all infants weighing >2 kg
“On a case-by-case basis and only in rare circumstances, the first dose may be delayed until after hospital discharge …”
MMWR Recomm Rep. 2005;54:1-31

6. Current Practice
Providers and hospitals appear to have a wide variation in practices and policies
Hospitals have a variety of policies:
Identification of mothers who are hepatitis B + or unknown with targeted intervention
The above plus a “universal birth dose” policy, such that parents of all infants are offered hepatitis B vaccine for their newborn
No policy
Cooper et al. Pediatrics Dec;108(6):E98.
Willis et al. Pediatrics Apr; 125(4):

7. What are the risk factors associated with non-receipt of hepatitis B vaccine in the newborn nursery?

8. Objectives
Describe hospital policies for newborn hepatitis B prevention
Describe regional variation of receipt of hepatitis B vaccine
Determine factors associated with non-receipt of hepatitis B vaccine in the infant, including maternal characteristics and effect of hospital policy

9. Study Design Retrospective cohort study
2008 Colorado Birth Certificate Registry data
Policy information obtained by Perinatal Hepatitis B Prevention Unit at state health department
All birth facilities (n=56)
survey, phone calls, site visits

10. Population All live births in Colorado during the year 2008 (n=70,838)
Exclusion criteria (n=6413):
Prematurity (< 36 weeks’ gestation)
< 2000 g birth weight
Assisted ventilation > 6 hours
Neonatal sepsis
Meconium aspiration syndrome

11. Hospital Policy
“Birth Dose” was defined as having a written policy to offer the parents of all newborn infants hepatitis B vaccine prior to discharge
Hospital policy – 3 categories:
No policy
Policy to review maternal hepatitis B status but not including a birth dose
Policy including a birth dose

12. Geographic Information Systems (GIS) Mapping
To examine variation in receipt of hepatitis B vaccine in the newborn period
State of Colorado
Percent of infants who received hepatitis B vaccine prior to hospital discharge by county of residence

13. Statistical Analysis
Multiple logistic regression with the primary outcome: non-receipt of hepatitis B vaccination
Adjusted for variables chosen on basis of existing literature and expert opinion
Maternal age, race/ethnicity, household income, maternal education, insurance status, hospital policy

14. Results: Hospital Policy Survey
56/56 (100%) birthing facilities in the state of Colorado responded to the survey

15. Results: Hospital Policy
Percent of delivery facilities (n=56)
Review maternal hepatitis B status but NO written policy to offer hepatitis B vaccine to all newborns
61%
Review maternal hepatitis B status AND a written policy to offer hepatitis B vaccine to all newborns
30%
No policy 9%
Here are the results of the hospital policy survey.

16. Results: Hospital Policy
Percent of delivery facilities (n=56)
Review maternal hepatitis B status but NO written policy to offer hepatitis B vaccine to all newborns
61%
Review maternal hepatitis B status AND a written policy to offer hepatitis B vaccine to all newborns
30%
No policy 9%
61% of the facilities had a policy to review maternal hepatitis B status but without a written policy to offer hepatitis B vaccine to all newborns.

17. Results: Hospital Policy
Percent of delivery facilities (n=56)
Review maternal hepatitis B status but NO written policy to offer hepatitis B vaccine to all newborns
61%
Review maternal hepatitis B status AND a written policy to offer hepatitis B vaccine to all newborns
30%
No policy 9%
30% had…

18. Results: Hospital Policy
Percent of delivery facilities (n=56)
Review maternal hepatitis B status but NO written policy to offer hepatitis B vaccine to all newborns
61%
Review maternal hepatitis B status AND a written policy to offer hepatitis B vaccine to all newborns
30%
No policy 9%
And finally, 9% had…

19. State of Colorado. Percent of Infants Who Received Hepatitis B Vaccine, by County
Percent Receiving Vaccine
This is a map of the state of Colorado with percentage of infants who received vaccine by county.

20. State of Colorado. Percent of Infants Who Received Hepatitis B Vaccine, by County
Percent Receiving Vaccine
Note the scale on the right. The lighter yellow color signifies newborn hepatitis B birth dose rates of under 20% whereas the dark red color at bottom indicates rates of over 80%.

21. State of Colorado. Percent of Infants Who Received Hepatitis B Vaccine, by County
Percent Receiving Vaccine
For your reference, Denver and the rest of the Front Range of Colorado is located in the upper middle portion of the map, where the majority of the state lives, and mostly has rates in the 40 to 80% range. The rest of the state is fairly rural…

22. State of Colorado. Percent of Infants Who Received Hepatitis B Vaccine, by County
Percent Receiving Vaccine
And in these rural areas, we were able to show a four fold variation in receipt of hepatitis B vaccine. Note the red areas in the lower right portion of the map – this is the rural southeast of Colorado – had among the highest rates, over 80%,

23. State of Colorado. Percent of Infants Who Received Hepatitis B Vaccine, by County
Percent Receiving Vaccine
while other rural areas had rates less than 20%, in the lighter yellow color. Due to the limits of our dataset, we were unable to explore this further, but we suspect it may be associated with hospital policy.

24. Overall Vaccination Rate
61.2% of newborns in cohort received hepatitis B vaccine prior to hospital discharge

25. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Maternal age, years – mean (SD)
27.3 (6.1)
28.7 (6.1)
Race/Ethnicity, %
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
Native American/Alaskan
Other/Unknown
56%
30% 5% 3% 1%
64%
22% 4%
Marital Status, %
Married
Never Married
Divorced
72%
26% 2%
79%
20%
Here are the characteristics of our study population, showing demographic characteristics based on whether or not an infant received a hepatitis B vaccine.

26. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Maternal age, years – mean (SD)
27.3 (6.1)
28.7 (6.1)
Race/Ethnicity, %
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
Native American/Alaskan
Other/Unknown
56%
30% 5% 3% 1%
64%
22% 4%
Marital Status, %
Married
Never Married
Divorced
72%
26% 2%
79%
20%
To walk you through these next few slides, columns are divided into infants who received a hepatitis B vaccine and those that did not.

27. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Maternal age, years – mean (SD)
27.3 (6.1)
28.7 (6.1)
Race/Ethnicity, %
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
Native American/Alaskan
Other/Unknown
56%
30% 5% 3% 1%
64%
22% 4%
Marital Status, %
Married
Never Married
Divorced
72%
26% 2%
79%
20%
100%
…with the columns adding up to 100% for each category.

28. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Maternal age, years – mean (SD)
27.3 (6.1)
28.7 (6.1)
Race/Ethnicity, %
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
Native American/Alaskan
Other/Unknown
56%
30% 5% 3% 1%
64%
22% 4%
Marital Status, %
Married
Never Married
Divorced
72%
26% 2%
79%
20%
The first thing to note on this slide is that mothers of infants who did not receive hepatitis B vaccine were slightly older than mothers of infants who did receive the vaccine.

29. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Maternal age, years – mean (SD)
27.3 (6.1)
28.7 (6.1)
Race/Ethnicity, %
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
Native American/Alaskan
Other/Unknown
56%
30% 5% 3% 1%
64%
22% 4%
Marital Status, %
Married
Never Married
Divorced
72%
26% 2%
79%
20%
Regarding race/ethnicity, note that there was a higher percentage on non-Hispanic white mothers whose infants did not receive the vaccine, and the converse was true for Hispanic mothers: the percentage of mothers whose infants received the vaccine was higher than those that did not.

30. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Insurance, %
Medicaid
Private
Self-Pay
Other/Unknown‡ 40 47 4 9 26 65 3 6
This slide shows maternal insurance status.
‡ ‘Other’ category includes Medicaid pending, Child Health Plan, Veterans Administration, Correctional Facility, Unknown, etc.

31. Maternal Demographic Characteristics
+ Hep B Vaccine, n=39,703
No Hep B Vaccine, n=24,722
Insurance, %
Medicaid
Private
Self-Pay
Other/Unknown‡ 40 47 4 9 26 65 3 6
Here, we see that for those that received the hepatitis B vaccine, the percentage was higher for Medicaid and lower for private insurance when compared to those that did not receive it.
‡ ‘Other’ category includes Medicaid pending, Child Health Plan, Veterans Administration, Correctional Facility, Unknown, etc.

32. Non-Receipt Hepatitis B Vaccine:
Household Income
These next 3 slides will illustrate in a descriptive manner, percentages of infants who did not receive HBV vaccine. There are some mental gymnastics here, as I am presenting somewhat of a double negative, so bear with me. The bigger bars on these slides are showing the percentages of non-receipt, so smaller is better. This slide illustrates that as household income increases, the percentage of infants who received HBV decreases.

33. Non-Receipt of Hepatitis B Vaccine:
Maternal Education
This slide shows [title]. Here, we see that as maternal education increases, the percent of newborns not given hepatitis B vaccine also increases.

34. Non-Receipt of Hepatitis B Vaccine:
Hospital Policy
This slide illustrates non-receipt of HBV by hospital policy. Again, smaller is better. Note that the percentage of infants who did not receive HBV is lowest for hospitals with policies that include a birth dose…

35. Non-Receipt of Hepatitis B Vaccine:
Hospital Policy
This slide illustrates [title]. Note that the percentage of infants who did not receive HBV is lowest for hospitals with policies that include a birth dose, followed by hospitals with no hepatitis b policy at all, and the highest percentage of non-receipt was in the hospitals that had policies but did not include a universal birth dose in that policy.

36. Non-Receipt of Hepatitis B Vaccine:
Hospital Policy
followed by hospitals with no hepatitis b policy at all,

37. Non-Receipt of Hepatitis B Vaccine:
Hospital Policy
and the highest percentage of non-receipt was in the hospitals that had policies but did not include a universal birth dose in that policy.

38. Variables Associated with Non-Receipt of
Hepatitis B Vaccine
Characteristic
Unadjusted OR
Adjusted OR*
95% CI
Age
1.04
1.01
1.01, 1.02
Race/Ethnicity
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
American Indian/Alaskan
1.57
Ref
1.10
1.46
1.27
1.14
0.97
0.96
1.42
1.09, 1.19 --
0.89, 1.06
0.87, 1.06
1.20, 1.68
Household Income
< $15,000
$15,000-$24,999
$25,000-$34,999
$35,000-$49,999
$50,000-$74,999
$75,000 +
1.23
1.49
1.74
2.10
2.37
1.15
1.13
1.38
1.66
1.51
1.06, 1.25
1.03, 1.24
1.25, 1.52
1.49, 1.85
1.31, 1.74
These next two slides present the results of our multivariate analysis.
*Adjusted for: maternal age, race, household income, education, insurance, hospital policy, marital status, and gestational age (all significant)

39. Variables Associated with Non-Receipt of
Hepatitis B Vaccine
Characteristic
Unadjusted OR
Adjusted OR*
95% CI
Age
1.04
1.01
1.01, 1.02
Race/Ethnicity
White, Non-Hispanic
Hispanic
Black, Non-Hispanic
Asian
American Indian/Alaskan
1.57
Ref
1.10
1.46
1.27
1.14
0.97
0.96
1.42
1.09, 1.19 --
0.89, 1.06
0.87, 1.06
1.20, 1.68
Household Income
< $15,000
$15,000-$24,999
$25,000-$34,999
$35,000-$49,999
$50,000-$74,999
$75,000 +
1.23
1.49
1.74
2.10
2.37
1.15
1.13
1.38
1.66
1.51
1.06, 1.25
1.03, 1.24
1.25, 1.52
1.49, 1.85
1.31, 1.74
The most notable piece on this slide is that the adjusted ORs generally increase with increasing income, showing that when controlling for other factors, increasing income is associated with non-receipt of hepatitis B vaccine.
*Adjusted for: maternal age, race, household income, education, insurance, hospital policy, marital status, and gestational age (all significant)

40. Variables Associated with Non-Receipt of
Hepatitis B Vaccine
Characteristic
Unadjusted OR
Adjusted OR*
95% CI
Education
8th Grade or Less
9th-12th Grade, No Diploma
Some College
Bachelor’s Degree
Master’s Degree
Doctorate or Professional Degree
Ref
1.22
1.48
2.24
2.84
2.73
1.15
1.13
1.38
1.66
1.51 --
1.06, 1.25
1.03, 1.24
1.25, 1.52
1.49, 1.85
1.31, 1.74
Insurance
Medicaid
Private
Self-Pay
2.05
1.20
1.06
0.99
1.40, 1.55
0.96, 1.17
0.92, 1.06
Hospital Policy
No Policy
Policy Without Birth Dose
Policy Including Birth Dose
1.64
2.38
1.39
2.21
1.32, 1.47
2.13, 2.30
This slide shows more variables included in our logistic regression.
*Adjusted for: maternal age, race, household income, education, insurance, hospital policy, marital status, and
gestational age (all significant).

41. Variables Associated with Non-Receipt of
Hepatitis B Vaccine
Characteristic
Unadjusted OR
Adjusted OR*
95% CI
Education
8th Grade or Less
9th-12th Grade, No Diploma
Some College
Bachelor’s Degree
Master’s Degree
Doctorate or Professional Degree
Ref
1.22
1.48
2.24
2.84
2.73
1.15
1.13
1.38
1.66
1.51 --
1.06, 1.25
1.03, 1.24
1.25, 1.52
1.49, 1.85
1.31, 1.74
Insurance
Medicaid
Private
Self-Pay
2.05
1.20
1.06
0.99
1.40, 1.55
0.96, 1.17
0.92, 1.06
Hospital Policy
No Policy
Policy Without Birth Dose
Policy Including Birth Dose
1.64
2.38
1.39
2.21
1.32, 1.47
2.13, 2.30
Here, we see an impressive effect of maternal education on the adjusted Ors, with increasing maternal education showing increasing odds of non-receipt of hepatitis B vaccine.
*Adjusted for: maternal age, race, household income, education, insurance, hospital policy, marital status, and
gestational age (all significant).

42. Variables Associated with Non-Receipt of
Hepatitis B Vaccine
Characteristic
Unadjusted OR
Adjusted OR*
95% CI
Education
8th Grade or Less
9th-12th Grade, No Diploma
Some College
Bachelor’s Degree
Master’s Degree
Doctorate or Professional Degree
Ref
1.22
1.48
2.24
2.84
2.73
1.15
1.13
1.38
1.66
1.51 --
1.06, 1.25
1.03, 1.24
1.25, 1.52
1.49, 1.85
1.31, 1.74
Insurance
Medicaid
Private
Self-Pay
2.05
1.20
1.06
0.99
1.40, 1.55
0.96, 1.17
0.92, 1.06
Hospital Policy
No Policy
Policy Without Birth Dose
Policy Including Birth Dose
1.64
2.38
1.39
2.21
1.32, 1.47
2.13, 2.30
Finally, the highest odds ratio for non-receipt of hepatitis B vaccine was found in hospital policy. Having a written policy to offer hepatitis B vaccine to all newborns was the referent group. Having a policy to review maternal hepatitis B status but not a birth dose policy had an odds ratio of The interpretation of this is that after controlling for other factors such as race, household income, and maternal education, the odds of an infant not receiving hepatitis B vaccine are two-fold higher in hospitals without a birth dose policy compared to those that have one.
*Adjusted for: maternal age, race, household income, education, insurance, hospital policy, marital status, and
gestational age (all significant).

43. Summary of Results
Only about 1/3 of hospitals in Colorado were following ACIP recommendation to have a written policy for a birth dose of hepatitis B vaccine
Wide regional variation in receipt of hepatitis B vaccine in newborn nurseries in Colorado

44. Summary of Results
↑ Maternal education and income = ↓ hepatitis B vaccination rates
Hospital policy without universal birth dose = ↑ odds of non-receipt of hepatitis B vaccine
Infants born in hospitals without a universal birth dose policy → half as likely to receive hepatitis B vaccine
As maternal education and income increase, likelihood of receiving hepatitis B vaccine decreases
After controlling for maternal characteristics, a hospital policy that does not include a provision for a birth dose is associated with a higher odds of non-receipt of hepatitis B vaccine compared to hospitals with such a policy
Infants born in such hospitals are half as likely to receive hepatitis B vaccine when compared to infants born in hospitals with a birth dose policy

45. Limitations Based on one year of data (2008)
Sample size was large
Based only on data from Colorado
Birth certificate data
Possibly subject to misclassification bias
Unable to account for all potential confounders
Individual physician practices, vaccine refusal

46. Conclusions
An “opt out” policy for receiving hepatitis B vaccine appears much more effective than an “opt in” policy
Hospitals that have policies that do not include a birth dose should not consider that they are effectively preventing infants from acquiring hepatitis B
Hospitals and state governments should adopt written policies stating that parents of all infants are offered hepatitis B vaccine prior to discharge

47. Future Directions
Will we ever get to a point where hepatitis B vaccination is as routine as Vitamin K and eye ointment, with occasional refusals?

48. Acknowledgments Children’s Outcomes Research Program
Colorado Department of Public Health and Environment
Amy Warner
Kirk Bol
Department of Health and Human Services, Health Resources and Services Administration, National Research Service Award T32HP10006
Children’s Outcomes Research Program
Allison Kempe, MD, MPH
Michaela Brtnikova, PhD
Colorado School of Public Health
Dennis Lezotte, PhD
Ned Calonge, MD, MPH
Jill Norris, PhD