Birth defect classification by organ system: a novel approach to heighten teratogenic signalling in a pregnancy registry
Article first published online: 4 JUL 2002
Copyright © 2002 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 11, Issue 6, pages 465–475, September 2002
How to Cite
Scheuerle, A. and Tilson, H. (2002), Birth defect classification by organ system: a novel approach to heighten teratogenic signalling in a pregnancy registry. Pharmacoepidem. Drug Safe., 11: 465–475. doi: 10.1002/pds.726
- Issue published online: 26 SEP 2002
- Article first published online: 4 JUL 2002
- Manuscript Accepted: 19 MAR 2002
- Manuscript Revised: 14 MAR 2002
- Manuscript Received: 26 NOV 2001
- birth defect;
The Antiretroviral Pregnancy Registry (APR) is an ongoing international prospective exposure-registration cohort study that monitors outcomes of pregnancies exposed to marketed antiretroviral medications. The population of women exposed to antiretrovirals remains relatively small, which limits the power of the registry. In order to maximize identification of a teratogenic signal, a special birth defect classification system was devised. Birth defects were organized based upon organ system and embryology, using the Metropolitan Atlanta Congenital Defects Program as a model. Grouping defects that share embryology and pathogenesis increases the likelihood that a teratogenic effect will be apparent. The result is a three-tiered system: organ system, preferred defect term, and reported defect term. This system is text based, which eliminates the need to memorize codes and allows use by anyone familiar with medical terminology. Once established, the new APR Organ System Classification retains enough flexibility that categories may be collapsed or expanded as experience grows. Standardized nomenclature also minimizes variation introduced by collecting defect reports from many different sources. Copyright © 2002 John Wiley & Sons, Ltd.