Diana Valencia MS, R.J Berry, MD, MPH

National Center on Birth Defects and Developmental Disabilities

Centers for Disease Control and PreventionAtlanta, GA USA

Antiretroviral Therapy (ART) in Pregnancy, Breastfeeding and Beyond

Johannesburg, South Africa18-20 June, 2012

Public Health Birth Defects Surveillance

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

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What Are Birth Defects?

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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

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Source: March of Dimes 2006

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

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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

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Planning for Birth Defects Surveillance

Prevalence of Neural Tube Defects

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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)

Anencephaly

Neural Tube Defects

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Spina bifida

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

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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

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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

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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

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Example of abstraction form

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

• Verify data• Assign a number to each individual • Analyze data • Report data to MoH and other stake holders

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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

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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

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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

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QUESTIONS?

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For more information please contact Centers for Disease Control and Prevention

1600 Clifton Road NE, Atlanta, GA 30333Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov Web: http://www.cdc.gov

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

RJ Berry - rjb1@cdc.gov

Diana Valencia - ile9@cdc.gov

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