1. Public Health Birth Defects Surveillance
Diana Valencia MS,
R.J Berry, MD, MPH
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
Atlanta, GA USA
Antiretroviral Therapy (ART) in Pregnancy, Breastfeeding and Beyond
Johannesburg, South Africa
18-20 June, 2012

2. Public Health Birth Defects Surveillance
The ongoing and systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice 2

3. What Are Birth Defects?
Abnormalities of structure or function, present at birth with medical, social, or cosmetic consequences (typically requiring intervention)
More than 4,000 birth defects are known
Mental or physical disabilities or death
Leading cause of death in children under 5 years of age in many countries
~8 million babies are born/year worldwide with birth defects
Minor to severe
USA, most of Europe (if not the 1st the 2nd), Russia, Maldives 3

4. In Africa the prevalence of BD ranges from 52
In Africa the prevalence of BD ranges from 52.1/1000 to more than 70/1000
Source: March of Dimes 2006

5. Planning for Birth Defects Surveillance
Defining a public health problem
What are the real needs?
What is the perceived need or purpose for surveillance?
Are there concerns about exposure to Efavirenz (EFV) ?
What is the impact of Efavirenz therapy on neural tube defect rates/birth defect rates?
Who has a stake/interest in the solution or outcome?
Can surveillance help address the problem? How?
Base-line data
Serves as a sentinel system for birth defects vs. reassurance
Implementation of prevention strategies
People- nursing deficit, additional personnel
Training-newborn examination guidelines, id birth defects, coding completion of reporting form

6. Planning for Birth Defects Surveillance
Clear goals and objectives
Plan for implementation
Procurement of resources: people, time, infrastructure
Training of personnel
Harmonization with MoH data systems and forms
Quality and value: relevant, recent, reliable
Focus on quality (accuracy, timeliness, completeness)
Focus on the needs/purpose of the system
Plans for supervision/evaluation
Plans for analysis and reporting/communicating

7. Prevalence of Neural Tube Defects
Neural tube defects are rare
World estimate ~ 323,904 per year
Prevalence of 2.5/1,000 live births
Small studies in African hospitals
Prevalence 0.23/1,000 to 7/1,000 live births
Malawi: Queen Elizabeth Central Hospital
Prevalence of NTDs (0.62 /1,000)
Other birth defects
Orofacial clefts (0.67/1,000)
Hydrocephaly (0.23/1,000)
If the hospital has 15,000 births per year you would expect to ~9 babies born with NTDs and 10 babies with orofacial clefts in the hospital
94% have attended an antenatal clinic; 12% had folate /mv preconception and first trimester;
limitations;: teaching hospital, small study, not sure if all birth were evaluated- only the ones that make it to neonatal unit. ½ delivered in that hospital ½ born somewhere else.

8. Neural Tube Defects
Anencephaly
Spina bifida 8

9. Hospital-based Birth Defects Surveillance Systems
Advantages:
Requires fewer resources and simpler protocol
Can generate high quality case data, including exposures
Useful when trying to establish (approximate) baseline data
Useful for documenting that a problem exists or not
Useful for alerting health and government officials to the need for investing further in surveillance and prevention strategies
Very useful in settings where
Most births occur in hospitals
Surveillance at lower level facilities or in community is not feasible
Able to calculate a prevalence estimate for the condition in a particular hospital(s) if there is an accurate estimate of the source population/denominator for that hospital
Typically can be started more quickly; Typically participating clinicians are motivated ‘champions;
Need to know how many babies are born totally weekly/ montly in that hospital – very important to be diligent about examination of every single delivery 9

10. Hospital-based Birth Defects Surveillance Systems
Disadvantages:
Limited to prevalence estimates for hospital sites
Target population is limited to those born in the hospital sites where data are collected
Hospital participation can change over time, making the interpretation of findings and trends difficult
Prevalence estimates can be unreliable
Referral/selection bias can be variable, significant, difficult to estimate: extrapolation to entire population is uncertain
Selection of hospital based on better care, more deliveries… 10

11. Protocol for Data Collection
Standardize data collection
Uniform examination of all deliveries
Uniform identification of mothers on EFV-based ART
Uniform classification of birth defects
Uniform criteria for inclusion of cases
Uniform coding (ICD-10)
Use of structured abstraction form 11

12. Regional Workshop on Birth Defect Surveillance
Inclusion Criteria
All Live Births and Fetal Deaths (stillbirths)
Identified at participating hospital(s)
Birth defect must be diagnosed
At birth, or within the first 12 hours after birth 12
Diana Valencia 2012

13. Example of abstraction form13

14. Protocol for Birth Defects Surveillance
Protocol will be standard for every country
Hospitals will
Complete a reporting form for all deliveries
Make sure that forms are complete
Verify data
Send forms to a central office
Central office will
Assign a number to each individual
Analyze data
Report data to MoH and other stake holders 14

15. Potential Uses of Birth Defects Surveillance EFV-based ART Data
Surveillance for any increase in BD over and above expected baseline prevalence
Reassurance vs. elevated concern
Can be used to look at more than one exposure of concern: EFV, other ARVs, other new or commonly used drugs 15

16. Potential Uses of Birth Defects Surveillance Data
Case registry for case-control studies of possible risk
Link cases to health services
Case registry for studies of outcomes (e.g., survival, development)
Evaluate the impact of prevention interventions
Education, advocacy, and health promotion
Monitor trends

17. Why is Surveillance Important?
Without a surveillance system, you cannot
Capture adverse birth outcomes
Capture rare conditions
Identify potential risk factors
Efavirenz and NTDs
Estimate the prevalence of a condition in a population 17

18. QUESTIONS? 18

19. Regional Workshop on Birth Defect Surveillance
RJ Berry -
Diana Valencia -
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA
Telephone: CDC-INFO ( )/TTY:
Web:
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
National Center on Birth Defects and Developmental Disabilities
Division of Birth Defects and Developmental Disabilities 19
Diana Valencia 2012

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