title: Who seeks Teratology Information Service's advice? Assessing the risk of selection bias in observational cohort studies on drug risks in pregnancy.
abstract: All women of reproductive age should have access to Teratology Information Services (TIS). Observational cohort studies based on TIS data are one of the most important sources for risk characterization of drugs during pregnancy. A selection in TIS populations towards higher socioeconomic level would compromise the TIS' goal of health prevention and the quality of research. The aim of this study is to investigate in which respect Berlin TIS enquirers are different from the general female population of reproductive age in Germany. 5,239 women aged between 20 and 39 were compared with the general female population of reproductive age in Germany. Medium- and high-level educated women tend to be overrepresented among TIS enquirers. TIS should strive towards reaching subpopulations with poor access to health care. TIS-based observational studies require appropriate comparison cohorts from the same data pool with similar procedures of ascertainment to reduce the risk of selection bias.
authors.affiliation: Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy), Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address: evelin.beck@charite.de.
authors.forename: Evelin
authors.initials: E
authors.lastname: Beck
authors.affiliation: Berlin School of Public Health, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Lechner
authors.affiliation: Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy), Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Schaefer
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D000328:Adult; D015331:Cohort Studies; D016208:Databases, Factual; D004346:Drug Information Services; D005260:Female; D005858:Germany; D006801:Humans; D018811:Maternal Exposure; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D015983:Selection Bias; D012923:Social Class; D011795:Surveys and Questionnaires; D013723:Teratogens / Q000633:toxicity*; D055815:Young Adult
chemical_list: D013723:Teratogens
keywords: Drug risks; Drug safety; Educational attainment; Observational cohort study; Pregnancy; Socioeconomic status