1. Reduction in Infant Cardiac Deaths in US States Implementing Policies to Screen Newborns for Critical Congenital Heart Disease
Matthew Oster, MD, MPH
Washington, DC September 21, 2018
The findings and conclusions in this presentation have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy.

2. Objective
To estimate the effect of CCHD newborn screening policies on infant deaths from congenital heart disease in the United States

3. Study Design Difference-in-difference analysis
This method compares changes in outcomes following the introduction of a policy in groups with the policy and without the policy
Can be used to assess outcomes of policies adopted at different times by state or local governments
The method assumes similar pre-policy trends in outcomes and attributes different post-introduction trends, after controlling for state-specific factors, to policy

4. Data Source and Outcomes
Data source: Period Linked Birth-Infant Death Data files from National Center for Health Statistics
All births and infant deaths through end of 2013 by state of birth
Underlying and multiple causes of death from death certificates classified using ICD-10 codes
Two outcome measures – counts of infant deaths from 24 hours to under 6 months due to CCHD or due to other/unspecified CHD

5. Estimation Approach State screening policies by month of birth
Mandate implemented
Non-mandatory
Mandate adopted but not yet implemented
Voluntary screening policy
Poisson regression models
State screening policy in place at beginning of birth month
Log of number of births in month in state
Adjusted for state factors

6. CCHD Screening Policies as of June 1, 2013
States first adopted CCHD screening policies in mid-2011
7 states implemented mandates by June 1, 2013
2 states implemented mandates during August 2011-January 2012
5 implemented mandates during July 1, 2012-June 1, 2013
13 states adopted but did not yet implement mandates by June 1, 2013
4 other states adopted voluntary screening policies by June 1, 2013
Birth months through June 2013 included to allow for 6 months of death records

7. States That Implemented Screening Mandates by June 1, 2013
Date adopted
Date implemented
Connecticut
May 2012
January 1, 2013
Delaware
May 1, 2013
Indiana
May 2011
January 1, 2012
Maryland
May 19, 2011
September 1, 2012
New Hampshire
June 2012
August 11, 2012
New Jersey
June 2, 2011
August 31, 2011
Tennessee
March 1, 2012
May 31, 2013
West Virginia
April 5, 2012

8. Trends in CCHD Early Infant Death Rates, 2007-2012

9. Changes in Infant Deaths from CCHD or CHD During January 1, 2007-June 1, 2013.
All states
States with
no policy implemented
States with mandatory policy
States with non-mandatory policy
Characteristic
Before enactment
Between enactment and implementation
After implementation
After enactment
CCHD deathsa per 100,000 births
9.8
10.0
8.3
7.8
4.5
10.6
Other CHD deathsa per 100,000 births
13.5
13.4
12.0
11.5
8.5
14.8
13.8

10. Changes in Infant Deaths from CCHD or CHD During January 1, 2007-June 1, 2013.
All states
States with
no policy implemented
States with mandatory policy
States with non-mandatory policy
Characteristic
Before enactment
Between enactment and implementation
After implementation
After enactment
CCHD deathsa per 100,000 births
9.8
10.0
8.3
7.8
4.5
10.6
Other CHD deathsa per 100,000 births
13.5
13.4
12.0
11.5
8.5
14.8
13.8

11. Changes in Infant Deaths from CCHD or CHD During January 1, 2007-June 1, 2013.
All states
States with
no policy implemented
States with mandatory policy
States with non-mandatory policy
Characteristic
Before enactment
Between enactment and implementation
After implementation
After enactment
CCHD deathsa per 100,000 births
9.8
10.0
8.3
7.8
4.5
10.6
Other CHD deathsa per 100,000 births
13.5
13.4
12.0
11.5
8.5
14.8
13.8

12. Decline in death rate (%) (95% confidence interval)
Adjusted Percent Declines in Rates of CCHD and Other CHD Deaths Due to Mandatory Screening Policies
Decline in death rate (%)
(95% confidence interval)
Age range of deaths
CCHD deaths
Other CHD deaths
24 hours to <6 months
33.4%
21.4%
(10.6% %)
(6.9% %)
Sensitivity analyses – timing of mandate
Implemented Aug 2011-June 2012
19.7%
(3.1% – 37.1%)
21.7%
(8.7% %)
Implemented July 2012-June 2013
53.6%
21.0%
(36.0% %)
(0.3% %)
Adjusted for state-specific effects such as race, plurality, income, and unemployment rate

13. Key Findings – Effects of Screening Policies
Relative reductions in CCHD and Other CHD deaths compared to births in months with no state policy, adjusted for state factors and time trends
Mandatory screening
CCHD deaths to age 6 months fell by one-third (33.4%)
Other CHD deaths fell by one-fifth (21.4%)
Both changes were statistically significant
Non-mandatory screening
No reductions in CCHD or other CHD deaths (<5% difference, not statistically significant)

14. Extrapolation to Universal CCHD Screening in US
Potential reduction in annual deaths for US as a whole
Recognized CCHD deaths: 120 (95% CI: 38–181)/year
Other CHD deaths: 117 (95% CI: )/year
May represent undiagnosed or unrecorded CCHD deaths

15. Limitations and Next Steps
Small numbers of state birth-months exposed to state mandates
Limited to information provided on death certificate
CCHD vs. Other CHD
We used most recent data that were made available by NCHS. Updated analyses with more recent data are ongoing.

16. Broader limitations Effect is limited to policy only
Does not necessarily reflect practice
Unknown: What is actual effect of hospital implementation?

17. Conclusions
Mandatory policies for CCHD screening using pulse oximetry had a significant impact on infant deaths
Estimate ~120 fewer infant deaths/year in US due to recognized CCHD with a universal mandatory screening policy
Estimate ~117 fewer infant deaths/year in US due to “other CHD” with a universal mandatory screening policy
These estimates may help inform policy decisions in other countries

18. Thank you
Rahi Abouk, PhD William Paterson University, Cotsakos College of Business
Scott Grosse, PhD
Elizabeth Ailes, PhD Centers for Disease Control and Prevention, National Center on Birth Defects and Developmental Disabilities

19. Regression Results: Effects of CCHD Screening Policies
Poisson regression coefficient
(95% confidence interval)
Explanatory variable
CCHD deaths
Other CHD deaths
Mandatory CCHD screening
-0.406
-0.241
(-0.699, )*
(-0.410, )*
Non-mandatory CCHD screening
-0.065
-0.016
(-0.244, 0.114)
(-0.233, 0.201)

20. Tests of Non-Parallel Trends Hypothesis
Regression coefficients on linear time interacted with the screening policy variables (mandatory and non-mandatory vs. no policy)
Mandatory screening: (95% CI: to 0.006)
Non-mandatory screening: (95% CI: to 0.136)

21. Falsification Analysis
Infant deaths for other leading causes substituted for CCHD/CHD – all confidence intervals overlap zero
Cause of death
Coefficient (95% CI) for the effect of mandatory CCHD screening
Coefficient (95% CI) for the effect of non-mandatory CCHD screening
Sudden infant death syndrome
0.139
(-0.088, 0.367)
0.090
(-0.059, 0.239)
Bacterial sepsis of newborn
0.158
(-0.192, 0.507)
0.082
(-0.070, 0.234)
Maternal and placental complications
0.216
(-0.370, 0.803)
0.359
(-0.050, 0.768)
Short gestation and low birth weight
-0.171
(-0.483, 0.142)
-0.056
(-0.207, 0.095)