McMaster University

McMaster University

P.J. Devereaux

P.J. DevereauxTitle of presentation

"RCTs have we created a monster?"

Abstract

Although there is no doubt that the randomized controlled trial (RCT) is a powerful tool to evaluate therapeutic and prevention strategies, is it possible that clinical epidemiologists have gone too far in their zeal to turn the world onto RCTs? 

Most clinical epidemiology papers tell users of the medical research that randomization is the gold standard for determining the effect of an intervention.  These papers usually indicate that if the RCT methodology (e.g., concealment of randomization, complete follow-up) is appropriate and the results demonstrate a P value < 0.05, then we can believe the results.  Is it possible that this teaching may not infrequently mislead physicians? 

In this lecture I will discuss issues of the fragility of trial results and whether trials likely achieve their goal of balancing prognosis across intervention groups.

Profile

Dr. Devereaux, MD, PhD, obtained his medical degree from McMaster University and completed a residency in internal medicine at the University of Calgary and a residency in cardiology at Dalhousie University.  He then earned a PhD in Clinical Epidemiology at McMaster University.  Dr. Devereaux holds a Canadian Institutes of Health Research New Investigator Award. 

He was the Co-PI of the POISE-1 Trial, the world’s largest cardiac randomized controlled trial in patients undergoing non-cardiac surgery.  Dr. Devereaux is the PI of the VISION Study that is evaluating major vascular complications in a representative sample of 40,000 patients undergoing non-cardiac surgery in 14 centres in 7 countries.  He is also the PI of the POISE-2 Trial that is evaluating the effects of clonidine versus placebo and ASA versus placebo in a factorial 10,000 patient trial among patients undergoing non-cardiac surgery.

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