Presented at the 48th Annual Meeting of the Teratology Society, Monterey California, June 28–July 3, 2008.
Measurements of birth defect prevalence: Which is most useful as a comparator group for pharmaceutical pregnancy registries?†
Article first published online: 12 FEB 2009
Copyright © 2009 Wiley-Liss, Inc.
Birth Defects Research Part A: Clinical and Molecular Teratology
Volume 85, Issue 7, pages 611–620, July 2009
How to Cite
Scheuerle, A., Vannappagari, V. X. and Miller, M. K. (2009), Measurements of birth defect prevalence: Which is most useful as a comparator group for pharmaceutical pregnancy registries?. Birth Defects Research Part A: Clinical and Molecular Teratology, 85: 611–620. doi: 10.1002/bdra.20572
- Issue published online: 8 JUL 2009
- Article first published online: 12 FEB 2009
- Manuscript Accepted: 1 JAN 2009
- Manuscript Revised: 20 DEC 2008
- Manuscript Received: 7 SEP 2008
- birth defect;
- birth defect prevalence;
- pregnancy registry
Pharmaceutical pregnancy registries document birth defects and other complications reported in pregnancies exposed to specific medications or diseases. A baseline estimate of birth defect prevalence is necessary for comparison. To identify potential teratogenic signals, the pregnancy registry must have a comparator that most closely matches the exposed population and data collection methodology, which are characteristics that vary among the multiplicity of birth defect surveillance systems. The system that yields the most accurate prevalence data may be different from that most closely matching the pregnancy registry methods. State public health programs have highly accurate and precise statistics, but their populations are broader than those of a pharmaceutical pregnancy registry. Large collaborative databases may have a more useful covered population, but there are secondary problems related to data precision. Health care databases enroll large numbers of patients and have good information about exposures and health problems, but the data can be difficult to access and lack useful detail. Exposure-related databases are closer in population definition and collection methods, though the presence of different diseases and exposures can be problematic. Internal comparators are likely to be most useful in formal statistical analysis, but added cost and management burden and may require significantly increased registry enrollment. There is no ideal comparator, and this must be taken into account when planning a single-exposure or single-disease pregnancy registry. Birth Defects Research (Part A), 2009. © 2009 Wiley-Liss, Inc.