Application of data screening to drug exposure in large risk factor studies of birth defects

摘要: Background Birth defects are the leading cause of infant death. While causes most unknown, those that might be due to medication use among preventable. This study describes an approach identifying medications warrant attention by using a “screen” program calculates odds ratios for pairs exposures and specific birth defects. Methods We discuss development this tool illustrate its application two large risk factor studies, Slone Epidemiology Center's Birth Defects Study Centers Disease Control Prevention's National Prevention Study, ideal settings systematic risks relative safety drugs in relation while recognizing inherent limitations such approach. Results Suggestions establishing criteria outcomes balance need details with practical considerations sample size volume output presented. Selection appropriate exposure reference categories control groups is also discussed, as well address potential confounding. An example motivated detailed investigation possible associations between (butalbital) selected provided. Conclusion While screening programs one described can valuable exploring data bases, they must applied caution. The issue multiple testing chance findings major concern. statistics necessary component, human judgment integral part process. Research (Part A), 2015. © 2015 Wiley Periodicals, Inc.