By Bengt Källén
This publication addresses methodological facets of epidemiological reports on maternal drug use in being pregnant. Discussing the present resources of errors and the way they could produce fallacious conclusions, it examines numerous epidemiological options and assesses their strengths and weaknesses. those refer either to the id of results (with distinctive emphasis on congenital malformations) and to the kinds of publicity (drug use).
Further, the e-book discusses the matter of confounding and the way to address it, and gives an easy advent to statistical data. specified events, e.g. kinds of parental publicity, are tested. finally, the e-book discusses pharmacovigilance and the knowledge challenge, concluding with a quick checklist of features to contemplate whilst one desires to review a broadcast paper within the box.
Though the publication is essentially meant for pharmacologists, gynecologists and obstetricians, it is going to profit all medical professionals operating in perinatal care.
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Extra info for Drugs During Pregnancy: Methodological Aspects
This age varies somewhat between populations. The classical limit is drawn when an infant born has a chance to survive after birth. Today the limit is around 22 weeks and this limit is therefore used for instance in Sweden as the lower gestational age limit to define an infant which was born dead. Historically, the limit was higher. Up to 2002 an age limit of 28 weeks was used in Sweden to define a dead fetus as an infant – if it was alive at birth it was defined as an infant, also if born before the 28th week.
1136/archdischild-2014-308013 24 4 Some Epidemiological Principles Broussard CS, Rasmussen SA, Reefhuis J, Friedman JM, Jann MW, Riehle-Colarusso T, Honein MA, National Birth Defects Prevention Study (2011) Maternal treatment with opioid analgesics and risk of birth defects. e1–e11 Clementi M, Di Gianantonio E, Cassina M, Leoncini E, Botto LD, Mastroiacovo P, Safe-Med Study Group (2010) Treatment of hyperthyroidism in pregnancy and birth defects. J Clin Endocrinol Metab 95:E337–E341 Dolk H, Jentink J, Loane M, Morris J, de Jong/van den Berg LT, EUROCAT Antiepileptic Drug Working Group (2008) Does lamotrigine use in pregnancy increase orofacial cleft risk relative to other malformations?
Often the tenth percentile is used to define growth retardation, sometimes two standard deviations from the mean weight. Usually such growth diagrams are based on the mean and distribution of the birth weights for each gestational week. This means that pathological conditions are included in what is supposed to be a normal population. Other methods have instead used weight modes for each week and estimated the standard deviation as 12 % of that weight – the 12 % come from 40-week pregnancies where the vast majority is normal (Källén 1995).