title: Promise and peril: Dissemination of findings from studies of drugs used in pregnancy and their association with birth defects.
abstract: BACKGROUND
  When and how to publish birth defects research can be complex, especially in the context of drugs used in pregnancy. Such research frequently involves multiple stakeholders, including regulatory agencies. Researchers must balance the potential peril of an unnecessarily panicked populace versus the benefit of protecting the public's health.
  
  
  METHODS
  We use a case presentation and contemporary literature to highlight the potential tradeoffs that researchers must consider. We highlight important considerations including the public health impact, examining the likelihood of causality, understanding common considerations when using large data sources, the role of peer review and working in partnership with regulatory agencies.
  
  
  RESULTS
  We suggest that plans for analyses, dissemination and risk communication are done best a priori and not post hoc.
  
  
  CONCLUSIONS
  Rigorous research evaluating the impact of drugs used in pregnancy, coupled with effective dissemination strategies, has the potential improve outcomes for mothers and their infants for generations.
authors.affiliation: Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.|Mildred Stahlman Division of Neonatology, Vanderbilt University, Nashville, Tennessee.|Vanderbilt Center for Health Services Research, Nashville, Tennessee.|Department of Health Policy, Vanderbilt University, Nashville, Tennessee.
authors.forename: Stephen W
authors.initials: SW
authors.lastname: Patrick
authors.affiliation: Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.|Vanderbilt Center for Health Services Research, Nashville, Tennessee.|Department of Health Policy, Vanderbilt University, Nashville, Tennessee.
authors.forename: William O
authors.initials: WO
authors.lastname: Cooper
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000013:Congenital Abnormalities / Q000209:etiology*; D005260:Female; D006801:Humans; D018811:Maternal Exposure / Q000009:adverse effects*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology*; D011256:Pregnancy Outcome; D012042:Registries; D012307:Risk Factors
chemical_list: D004364:Pharmaceutical Preparations
keywords: birth defect; dissemination; peer review; pharmacoepidemiology and drug safety