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American Journal of Epidemiology Vol. 153, No. 2 : 108-109
Copyright © 2001 by The Johns Hopkins University School of Hygiene and Public Health

ORIGINAL CONTRIBUTIONS

Invited Commentary: Rare Side Effects of Obstetric Interventions: Are Observational Studies Good Enough?

Pierre Buekens

From the Department of Maternal and Child Health, School of Public Health, Rosenau Hall, CB#7400, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599–7400 (e-mail: Pierre_Buekens@unc.edu).

Abbreviations: FDA, Food and Drug Administration.


   INTRODUCTION
 
In this issue of the Journal, Wen et al. (1Go) used an observational design to compare the side effects of vacuum extraction and forceps among babies in Quebec, Canada, who weighed between 2,500 and 4,000 g. The use of case-control and cohort designs for the general purpose of studying side effects has been recommended for more than 2 decades (2Go). The sample size of randomized trials is often not large enough to evaluate uncommon side effects of therapy. Observational studies of side effects of drugs are . . . [Full Text of this Article]


   NOTES
 

   REFERENCES
 

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Related articles in Am. J. Epidemiol.:

Comparison of Maternal and Infant Outcomes between Vacuum Extraction and Forceps Deliveries
Shi Wu Wen, Shiliang Liu, Michael S. Kramer, Sylvie Marcoux, Arne Ohlsson, Reg Sauvé, and Robert Liston
Am. J. Epidemiol. 2001 153: 103-107. [Abstract] [FREE Full Text]