Safer Pregnancies? Toward improving patient-provider interactions involving birth defects risks

Background: Although incidence of birth defects caused by teratogen exposure is extremely low (< 4,000/year), such exposure is almost entirely preventable. Patient concerns about exposures are far more common, and healthcare providers must counsel women about products, environments, and diseases with teratogenic risks without fostering unfounded alarm and overreaction. Consumers need explanations and examples that are understandable and accurate; healthcare providers need quick easy access to resources. The FDA's pharmaceutical pregnancy category scale and the PDR have limitations, and narrative reviews of published teratology information have been suggested as an alternative basis for counseling patients.

Purpose: To generate an evidence-based framework for assessing narrative reviews of teratology information and to create e-learning resources to increase providers' and patients' access to and ability to critically evaluate information regarding teratogenic risk.

Methodology: Model and content development rested upon analysis of teratogen exposure case studies as well as a think-aloud protocol that elicited heuristics from an expert teratogen counselor. Four teratology experts were recruited to validate the heuristics, and a series of case studies illustrating use of the heuristics. Information and recommendations for the provider and patient courses and materials were generated and validated in consultation with a national teratology support organization.

Results: The resulting model included three patient-focused—Development Stage, Concurrent Exposure, and Genetics—and three agent-focused—Nature, Dose, and Route—dimensions. The two e-learning courses feature rich-media explanations and case examples.

Supported by CDC/NCBDDD grant#R44DD00001, this session will discuss the model and its genesis and demonstrate and discuss the e-learning materials.