Methodology Score: 3/5
Usefulness Score: 2.5/5
Keh D, et al.
JAMA. 2016 Nov 1;316(17):1775-1785
In this multicenter placebo-controlled double-blind RCT, the authors concluded that in adults with severe sepsis, hydrocortisone IV infusion does not prevent progression of severe sepsis to septic shock. While this study was well done overall, the group had concerns about the removal of patients with adverse events from the modified intention-to-treat analysis, the lack of reporting of time to antibiotics, powering the study to detect a very high (15%) difference between groups. This not being an ED study the results are not applicable to our population.
By: Dr. Stephanie Barnes
Yende S, et al.
Evaluating Glucocorticoids for Sepsis: Time to Change Course.
JAMA. 2016 Nov 1;316(17):1769-1771.
Randomization by Pocock minimization algorithm February 2017
A random allocation of patients to treatment-control group (by sealed envelopes etc.) generally leads to balanced groups but can lead to differences in the groups on some aspects (more males or obese patients in one arm than the other). If important factors of identified (e.g. sex, obesity) then the patients could be stratified based on sex and BMI. Using block randomization a list is created for a block of x patients to be equally assigned to the study arms based on the important factors identified. If there a large number of important factors, then the block randomization becomes extremely complex. Pocock and Simon adaptive stratified sampling algorithm can be used to calculate the imbalance between the groups based on each factor and add an additional random element to assignment of the next patient.
By: Dr. Venkatesh Thiruganasambandamoorthy