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Editorial
. 2016 Oct 21;16(1):102.
doi: 10.1186/s12871-016-0265-3.

Randomized controlled trials vs. observational studies: why not just live together?

David Faraoni  1 , Simon Thomas Schaefer  2
Affiliations
Editorial

Randomized controlled trials vs. observational studies: why not just live together?

David Faraoni et al. BMC Anesthesiol. .

Abstract

Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

Keywords: Good clinical practice; Metaanalysis; Observational studies; Randomized controlled trials; Study planning.

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Figures

Fig. 1
Fig. 1
Relationship between the volume of red blood cells transfused and the odds of a bad outcome in two different patients, after taking into consideration the underlying condition (e.g. anemia [Zone 1], hemorrhage [Zone 3]) and the volume of blood loss
See this image and copyright information in PMC

References

    1. Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012;4:CD002042. - PMC - PubMed
    1. Holst LB, Petersen MW, Haase N, Perner A, Wetterslev J. Restrictive versus liberal transfusion strategy for red blood cell transfusion: systematic review of randomised trials with meta-analysis and trial sequential analysis. BMJ. 2015;350:h1354. doi: 10.1136/bmj.h1354. - DOI - PMC - PubMed
    1. Trentino K, Farmer S, Gross I, Shander A. Observational studies - should we simply ignore them in assessing transfusion outcomes? BMC Anesthesiol. 2016;16(1):96. - PMC - PubMed
    1. Sorensen HT, Lash TL, Rothman KJ. Beyond randomized controlled trials: a critical comparison of trials with nonrandomized studies. Hepatology. 2006;44(5):1075–82. doi: 10.1002/hep.21404. - DOI - PubMed
    1. Vincent JL. We should abandon randomized controlled trials in the intensive care unit. Crit Care Med. 2010;38(10 Suppl):S534–8. doi: 10.1097/CCM.0b013e3181f208ac. - DOI - PubMed

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