Application of data screening to drug exposure in large risk factor studies of birth defects.
Application of data screening to drug exposure in large risk factor studies of birth defects.
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药物暴露数据筛查在出生缺陷大危险因素研究中的应用。
DOI：
10.1002/bdra.23407
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
Mitchell,AllenA
中科院分区：
文献类型：
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作者：
Louik,Carol;Werler,Martha;Anderka,Marlene;Mitchell,AllenA
背景出生缺陷是婴儿死亡的主要原因。虽然大多数的原因是未知的，那些可能是由于药物使用是最可以预防的。这项研究描述了一种方法，以确定这些药物，最值得注意的是通过使用一个“屏幕”程序，计算比值比对暴露和特定的出生缺陷。MethodsWe讨论了这个工具的发展，并说明其应用到两个大的风险因素的研究，斯隆流行病学中心的出生缺陷研究和疾病控制和预防中心的国家出生缺陷预防研究，理想的设置系统研究的风险和相对安全的药物有关出生缺陷，同时认识到这样一种方法的固有局限性。ResultsSuggestions建立标准的暴露和结果，平衡需要的具体细节与实际考虑的样本量和输出量。还讨论了适当的暴露参考类别和对照组的选择，以及解决潜在混淆的必要性。一个例子，激发了一个详细的调查之间的可能关联的药物（布他比妥）和选定的特定出生缺陷provided.ConclusionWhile筛选程序，如所描述的一个可以是一个有价值的工具，探索潜在的关联在大型数据库，他们必须谨慎应用。多重测试和偶然发现的问题是一个主要问题。虽然统计数据是一个必要的组成部分，但人的判断必须是这一过程的一个组成部分。出生缺陷研究（A部分）103：713-717，2015年。© 2015 Wiley Periodicals，Inc.
BackgroundBirth defects are the leading cause of infant death. While causes of most are unknown, those that might be due to medication use are among the most preventable. This study describes an approach to identifying those medications that most warrant attention by using a “screen” program that calculates odds ratios for pairs of exposures and specific birth defects.MethodsWe discuss the development of this tool and illustrate its application to two large risk factor studies, the Slone Epidemiology Center's Birth Defects Study and the Centers for Disease Control and Prevention's National Birth Defects Prevention Study, ideal settings for the systematic study of risks and relative safety of drugs in relation to birth defects while recognizing the inherent limitations of such an approach.ResultsSuggestions for establishing criteria for exposures and outcomes that balance the need for specific details with the practical considerations of sample size and volume of output are presented. Selection of appropriate exposure reference categories and control groups is also discussed, as well as the need to address potential confounding. An example that motivated a detailed investigation of possible associations between a medication (butalbital) and selected specific birth defects is provided.ConclusionWhile screening programs such as the one described can be a valuable tool for exploring potential associations in large data bases, they must be applied with caution. The issue of multiple testing and chance findings is a major concern. While statistics are a necessary component, human judgment must be an integral part of the process. Birth Defects Research (Part A) 103:713–717, 2015. © 2015 Wiley Periodicals, Inc.