Journal Club Summary
Methodology Score: 3.5/5
Usefulness Score: 3/5
Ventura AMC, et al.
Crit Care Med. 2015 Nov;43(11):2292-302
This well designed RCT demonstrated that in fluid refractory pediatric septic shock, dopamine is associated with increased mortality and higher rates of healthcare associated infections compared to epinephrine. Many expressed concern regarding lack of predefined criteria for early termination, low dopamine doses, prolonged resuscitation in dopamine group, and the high rate of open-label pressors but this is the best evidence available on vasopressors in pediatrics.
By: Dr. Jean-Christophe Ghazal
Interim analyses are commonly planned in large studies. This can be useful, for example, to ensure patient safety (either by finding a significant benefit or harm early on), or as a cost saving measure by stopping the study early if there is no statistical probability to find a difference between groups later on. There are caveats to interim analyses. It is possible for a perceived “futile” study to become significant if allowed to continue on (lack of power to find a difference early on). It is also possible to find a significant difference early on by chance alone. Because the likelihood to find a difference by chance alone increases every time you analyze the data, there are strategies to account for this (such as O’Brien Fleming), most of which include raising the bar for statistical significance (i.e. p-value much smaller than 0.05 or using >95%CI instead).
By: Dr. Christian Vaillancourt