Identifying birth defects in automated data sources in the Vaccine Safety Datalink

Details

• Alternative Title:
  Pharmacoepidemiol Drug Saf
• Personal Author:
  Kharbanda, Elyse Olshen ; Vazquez-Benitez, Gabriela ; Romitti, Paul A. ; Naleway, Allison L. ; Cheetham, T. Craig ; Lipkind, Heather S. ; Sivanandam, Shanthi ; Klein, Nicola P. ; Lee, Grace M. ; Jackson, Michael L. ; Hambidge, Simon J. ; Olsen, Avalow ; McCarthy, Natalie ; DeStefano, Frank ; Nordin, James D.
• Description:
  Purpose
  
  The Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations, aims to monitor safety of vaccines administered in the USA. We present definitions and prevalence estimates for major structural birth defects to be used in studies of maternal vaccine safety.
  
  Methods
  
  In this observational study, we created and refined algorithms for identifying major structural birth defects from electronic healthcare data, conducted formal chart reviews for severe cardiac defects, and conducted limited chart validation for other defects. We estimated prevalence for selected defects by VSD site and birth year and compared these estimates to those in a US and European surveillance system.
  
  Results
  
  We developed algorithms to enumerate >50 major structural birth defects from standardized administrative and healthcare data based on utilization patterns and expert opinion, applying criteria for number, timing, and setting of diagnoses. Our birth cohort included 497 894 infants across seven sites. The period prevalence for all selected major birth defects in the VSD from 2004 to 2013 was 1.7 per 100 live births. Cardiac defects were most common (65.4 per 10 000 live births), with one-fourth classified as severe, requiring emergent intervention. For most major structural birth defects, prevalence estimates were stable over time and across sites and similar to those reported in other population-based surveillance systems.
  
  Conclusions
  
  Our algorithms can efficiently identify many major structural birth defects in large healthcare datasets and can be used in studies evaluating the safety of vaccines administered to pregnant women.
  
  
• Subjects:
  Adolescent Adult Adverse Drug Reaction Reporting Systems Algorithms Congenital Abnormalities Female Humans Infant Male Middle Aged Population Surveillance Pregnancy Prevalence Vaccines Young Adult

  More +
• Source:
  Pharmacoepidemiol Drug Saf. 26(4):412-420
• Pubmed ID:
  28054412
• Pubmed Central ID:
  PMC6506837
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Place as Subject:
  United States
• Volume:
  26
• Issue:
  4
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:b5ddec95996f12c2d2dee00b07191fb884f2f4af150e6eab302dd868a602a7fe
• Download URL:
  https://stacks.cdc.gov/view/cdc/78386/cdc_78386_DS1.pdf
• File Type:
  [PDF - 423.71 KB ]