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Psychopharmacology and Pregnancy pp 19–31Cite as

Critical Evaluation of the Literature: Understanding the Complexities of Observational Research

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Abstract

Studying the safety of drugs used in pregnancy, especially psychotropics, is a complicated process with currently no ideal model for conducting studies. Because of the ethical issues surrounding pregnancy it is highly unlikely Randomized Controlled Trials (RCTs) will ever be conducted. Consequently, observational studies are used and all of the models have their limitations, such as small sample size, retrospective bias, inability to know exactly if the women took their medication in pregnancy, and other missing data. However, this does not mean that the data collected are not valuable and useful to provide evidence-based information. Psychopharmacology and pregnancy is a highly sensitive topic with healthcare providers, with the media being very interested and eager to report findings, especially if adverse effects are reported. Consequently, it is of great importance when evaluating these studies, to point out the limitations of each study and how it may affect the results. For best evidence, a combination of these different types of observational studies will assist women and their healthcare providers in making informed decisions as to whether or not to take a particular drug during pregnancy.

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Author information

Authors and Affiliations

  1. The Hospital for Sick Children, Toronto, ON, Canada, M5G 1X8

    Adrienne Einarson

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  1. Adrienne Einarson
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Correspondence to Adrienne Einarson .

Editor information

Editors and Affiliations

  1. Perinatal Mental Health, Mercy Hospital for Women, Heidelberg, Australia

    Megan Galbally

  2. Perinatal Mental Health, Mercy Hospital for Women, Heidelberg, Australia

    Martien Snellen

  3. School of Psychology, Deakin University, Victoria, Australia

    Andrew Lewis

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© 2014 Springer-Verlag Berlin Heidelberg

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Einarson, A. (2014). Critical Evaluation of the Literature: Understanding the Complexities of Observational Research. In: Galbally, M., Snellen, M., Lewis, A. (eds) Psychopharmacology and Pregnancy. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-54562-7_3

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  • DOI: https://doi.org/10.1007/978-3-642-54562-7_3

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  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-54561-0

  • Online ISBN: 978-3-642-54562-7

  • eBook Packages: MedicineMedicine (R0)

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