Critical care trial design and interpretation: a primer.

Critical Care Medicine
Jonathan E SevranskyGreg S Martin

Abstract

Better understanding of the pathophysiology of critical illness has led to an increase in clinical trials designed to improve the clinical care and outcomes of patients with life-threatening illness. Knowledge of basic principles of clinical trial design and interpretation will assist the clinician in better applying the results of these studies into clinical practice. We review selected clinical trials to highlight important design features that will improve understanding of the results of critical care clinical trials designed to improve clinical care of the critically ill. Trial design features such as patient selection, bias, sample size calculation, selection of subjects and controls, and primary outcome measure may influence the results of a critical care clinical trial designed to test a therapy targeting improved clinical care. In conjunction with trial design knowledge, understanding the size of the anticipated treatment effect, the importance of any clinical end point achieved, and whether patients in the trial are representative of typical patients with the illness will assist the reader in determining whether the results should be applied to specific patients or usual clinical practice. Better understanding of impor...Continue Reading

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Citations

Feb 12, 2014·American Journal of Respiratory and Critical Care Medicine·Bronagh BlackwoodLouise Rose
May 3, 2014·American Journal of Respiratory and Critical Care Medicine·Michael O HarhayScott D Halpern
Jul 11, 2014·Chest·Sandra Zelman LewisKenneth R Casey
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Dec 26, 2013·Critical Care Medicine·Carmen C PolitoJonathan E Sevransky
Aug 10, 2021·Chest·Jun WatanabeTakashi Yoshioka

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