希望与风险：孕期用药研究结果的传播及其与出生缺陷的关联
Promise and peril: Dissemination of findings from studies of drugs used in pregnancy and their association with birth defects.
作者信息
Patrick Stephen W, Cooper William O
机构信息
Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Mildred Stahlman Division of Neonatology, Vanderbilt University, Nashville, Tennessee.
出版信息
Birth Defects Res A Clin Mol Teratol. 2015 Aug;103(8):729-32. doi: 10.1002/bdra.23409. Epub 2015 Jul 8.
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.
CONCLUSION
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.
背景
何时以及如何发表出生缺陷研究可能很复杂，尤其是在涉及孕期用药的情况下。此类研究通常涉及多个利益相关者，包括监管机构。研究人员必须在民众不必要恐慌的潜在风险与保护公众健康的益处之间取得平衡。
方法
我们通过一个案例展示和当代文献来突出研究人员必须考虑的潜在权衡。我们强调了重要的考虑因素，包括对公众健康的影响、审查因果关系的可能性、使用大数据源时的常见考虑因素、同行评审的作用以及与监管机构合作。
结果
我们建议分析、传播和风险沟通计划最好在事前而非事后制定。
结论
严格评估孕期用药影响的研究，再加上有效的传播策略，有可能改善几代母亲及其婴儿的结局。
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