Update in Critical Care 2005

Abstract

Randomized controlled trials (RCTs) stopped earlier than planned because of apparent benefit, such as PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) and the ARDS (Acute Respiratory Distress Syndrome) Network low tidal volume study, often generate considerable excitement and affect clinical practice. Montori and coworkers (1) systematically reviewed RCTs involving interventions stopped early for benefit, finding that such trials are becoming more common, often fail to adequately report relevant information about the stopping decision, and show implausibly large treatment effects, particularly when the number of events is small. Because the decision to stop is typically driven by highly significant p value thresholds, trials that are terminated early because of apparent benefit will frequently show large treatment effects, even when the number of events is large. In the future, journals should require adequate reporting about the stopping decision. Glance through any major medical journal and you will increasingly encounter terms from the world of molecular medicine that, unless you live in that world, are unfamiliar and sometimes meaningless. A supplement to Critical Care Medicine (2) attempts to demystify these terms with a series of short articles by international experts that use extensive illustrations and diagrams to emphasize the value of these concepts in the context of the “real world” practice of critical care medicine.