Journal Club Summary
Methodology Score: 1.5/5
Usefulness Score: 1/5
Baş M, Greve J, Stelter K, et al.
N Engl J Med. 2015 Jan 29;372(5):418-25
This small phase 2, multicenter, double blind randomized trial of 30 ED patients found a shorter time to complete resolution of ACE-I induced angioedema with a bradykinin antagonist, icatibant, compared with standard therapy (glucocorticoids and antihistamines). While the premise showed promise, JC attendees were disappointed by the lack of allocation concealment, no intention to treat analysis, loss to follow-up and wide confidence intervals. Further high quality study is required before considering this therapy for this challenging population.
By: Dr. Ian Taylor
Epi Lesson: Intention to Treat vs. Per Protocol Analyses
The standard analytic approach for RCTs is intention to treat (ITT), where patients are analysed in the groups to which they were allocated, irrespective of what they actually received. These analyses are intended to avoid over-estimation of a potential treatment effect if there are biases secondary to losses to follow-up or treatment non-adherence. It is legitimate to additionally conduct per protocol analyses (where patients are analysed according to what intervention they actually received) but these should not drive the final conclusions, particularly if the results are potentially influenced by these biases.
By: Dr. Lisa Calder