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Canadian Journal of Anesthesia/Journal canadien d'anesthésie
Published in: Canadian Journal of Anesthesia/Journal canadien d'anesthésie 7/2018

01-07-2018 | Special Article

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial

Authors: Jessica Spence, MD, Emilie Belley-Côté, MD, FRCPC, Shun Fu Lee, PhD, Shrikant Bangdiwala, PhD, Richard Whitlock, MD, PhD, FRCSC, Yannick LeManach, MD, PhD, Summer Syed, MD, MSc, FRCPC, Andre Lamy, MD, MHSc, FRCSC, Eric Jacobsohn, MBChB, MPHE, FRCPC, Sarah MacIsaac, HBSc, MSc, P. J. Devereaux, MD, PhD, FRCPC, Stuart Connolly, MD, FRCPC

Published in: Canadian Journal of Anesthesia/Journal canadien d'anesthésie | Issue 7/2018

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Abstract

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).
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Metadata
Title
The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial
Authors
Jessica Spence, MD
Emilie Belley-Côté, MD, FRCPC
Shun Fu Lee, PhD
Shrikant Bangdiwala, PhD
Richard Whitlock, MD, PhD, FRCSC
Yannick LeManach, MD, PhD
Summer Syed, MD, MSc, FRCPC
Andre Lamy, MD, MHSc, FRCSC
Eric Jacobsohn, MBChB, MPHE, FRCPC
Sarah MacIsaac, HBSc, MSc
P. J. Devereaux, MD, PhD, FRCPC
Stuart Connolly, MD, FRCPC
Publication date
01-07-2018
Publisher
Springer US
Published in
Canadian Journal of Anesthesia/Journal canadien d'anesthésie / Issue 7/2018
Print ISSN: 0832-610X
Electronic ISSN: 1496-8975
DOI
https://doi.org/10.1007/s12630-018-1130-2

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