title: Medical databases in studies of drug teratogenicity: methodological issues.
abstract: More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification) may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.
authors.affiliation: Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark;
authors.forename: Vera
authors.initials: V
authors.lastname: Ehrenstein
authors.forename: Henrik T
authors.initials: HT
authors.lastname: Sørensen
authors.forename: Leiv S
authors.initials: LS
authors.lastname: Bakketeig
authors.forename: Lars
authors.initials: L
authors.lastname: Pedersen