Journal Club Summary
Landmark Series
Methodology Score: 4/5
Usefulness Score: 4.5/5
Perner A, et al.; 6S Trial Group; Scandinavian Critical Care Trials Group.
N Engl J Med. 2012 Jul 12;367(2):124-34
This multi-centre, double-blind, RCT found that resuscitation of severely septic patients with Hydroxyethyl Starch 130/0.42 conferred a greater risk of renal replacement therapy and of death at 90 days when compared to Ringer’s acetate. Despite concerns regarding extensive cross-over between groups and the possibility of treatment confounders which may inherently arise in pragmatic trials, the group was convinced that this study was effective in adding to the growing body of evidence against the use of synthetic colloids in sepsis.
By: Dr. Magdalena Kisilewicz
(Presented September 2013)
Epi Lesson:
Explanatory versus Pragmatic Clinical Trials
Trials of healthcare interventions are often described as either explanatory or pragmatic. Explanatory trials generally measure efficacy – the benefit a treatment produces under ideal conditions, often using carefully defined subjects in a research clinic. Pragmatic trials measure effectiveness – the benefit the treatment produces in routine clinical practice. Pragmatic trials generally reflect the reality of how the intervention will perform in everyday care. For more, see http://www.bmj.com/content/316/7127/285.full
Trials of healthcare interventions are often described as either explanatory or pragmatic. Explanatory trials generally measure efficacy – the benefit a treatment produces under ideal conditions, often using carefully defined subjects in a research clinic. Pragmatic trials measure effectiveness – the benefit the treatment produces in routine clinical practice. Pragmatic trials generally reflect the reality of how the intervention will perform in everyday care. For more, see http://www.bmj.com/content/316/7127/285.full
By Dr. Ian Stiell
