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This book addresses methodological aspects of epidemiological studies on maternal drug use in pregnancy. Discussing the existing sources of error and how they can produce incorrect conclusions, it examines various epidemiological techniques and assesses their strengths and weaknesses. These refer both to the identification of outcomes (with special emphasis on congenital malformations) and to the types of exposure (drug use).
Further, the book discusses the problem of confounding and how to handle it, and provides a simple introduction to statistics. Special situations, e.g. different types of parental exposure, are examined. Lastly, the book discusses pharmacovigilance and the information problem, concluding with a short list of aspects to consider when one wants to evaluate a published paper in the field.
Though the book is primarily intended for pharmacologists, gynecologists and obstetricians, it will benefit all doctors working in perinatal care.
List of contents
Introduction.- The alert clinician.- Animal experiments and adverse drug reaction reports.- Some epidemiological principles.- Pregnancy outcomes with the exception of congenital malformations.- Congenital malformations.- Identification of maternal use of drugs.- The problem of confounding.- Statistics.- Lumping or splitting? Paternal use of drugs.- Timing of drug use and effects on the embryo or fetus.- Repeated studies and meta-analysis.- Pharmacovigilance.- Information on the risk with drug use during pregnancy.- Concluding remarks.
About the author
Bengt Källén is a professor emeritus of embryology at Lund University in Sweden and head of the Tornblad Institute for embryology. He has been working in birth defect epidemiology since the 1960s, and served from 1964 to 2015 as a consultant at the National Board of Health and Welfare in Stockholm, mainly focusing on the national registration of congenital malformations and analyses of reproduction outcome after exposure to various influences, including drugs. He is one of the founders of the Swedish Register of Congenital Malformations, and of the International Clearinghouse for Birth Defects Monitoring Systems. He has published ca. 400 scientific papers, including numerous articles on congenital malformations, the effects of maternal drug use during pregnancy, and in vitro fertilization.
Summary
This book addresses methodological aspects of epidemiological studies on maternal drug use in pregnancy. Discussing the existing sources of error and how they can produce incorrect conclusions, it examines various epidemiological techniques and assesses their strengths and weaknesses. These refer both to the identification of outcomes (with special emphasis on congenital malformations) and to the types of exposure (drug use).
Further, the book discusses the problem of confounding and how to handle it, and provides a simple introduction to statistics. Special situations, e.g. different types of parental exposure, are examined. Lastly, the book discusses pharmacovigilance and the information problem, concluding with a short list of aspects to consider when one wants to evaluate a published paper in the field.
Though the book is primarily intended for pharmacologists, gynecologists and obstetricians, it will benefit all doctors working in perinatal care.
Additional text
“This book addresses the methodology involved in evaluating drug studies. It is intended to highlight issues involved in studies of drugs in pregnancy. It is short and concise and an excellent contribution. The book is written for those with an interest in obstetrical drug studies. This can be physicians, epidemiologists, and other students.” (Anthony Shanks, Doody's Book Reviews, December, 2016)
Report
"This book addresses the methodology involved in evaluating drug studies. It is intended to highlight issues involved in studies of drugs in pregnancy. It is short and concise and an excellent contribution. The book is written for those with an interest in obstetrical drug studies. This can be physicians, epidemiologists, and other students." (Anthony Shanks, Doody's Book Reviews, December, 2016)
