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

Can J Anaesth. 2018 Jul;65(7):813-821. doi: 10.1007/s12630-018-1130-2. Epub 2018 Apr 18.

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).

Publication types

  • Comparative Study

MeSH terms

  • Anesthesia, Cardiac Procedures / methods*
  • Benzodiazepines / pharmacology
  • Cross-Over Studies
  • Data Collection
  • Data Interpretation, Statistical
  • Delirium / prevention & control*
  • Humans
  • Postoperative Complications / prevention & control*
  • Randomized Controlled Trials as Topic* / economics
  • Randomized Controlled Trials as Topic* / ethics
  • Sample Size

Substances

  • Benzodiazepines

Associated data

  • ClinicalTrials.gov/NCT03053869