Journal Club Summary
Methodology Score: 4.5/5
Usefulness Score: 4.5/5
Imazio M, et al. ICAP Investigators. N Engl J Med. 2013 Oct 17;369(16):1522-8.
This multicentre double-blind RCT found that a 3 month course of low-dose colchicine is superior to placebo in reducing recurrence rates after first-episode pericarditis (NNT 4, ARR 0.2, RRR 0.56). The group felt that colchicine should be considered in first-episode pericarditis, but raised concerns about the cost of the drug for patients with no drug coverage.
By: Dr. Christa Dakin
Epi lesson: Data Safety Monitoring Boards
Data Safety Monitoring Boards (DSMBs) are an independent group of experts created to allow blinded interim analysis in order to evaluate safety or efficacy of an intervention during an RCT. Stopping rules are created a priori such that if a significant difference during interim analysis is noted, then the study intervention is unblinded to ensure that it is not causing harm to patients or that the study could be stopped early due to clear evidence of benefit.
By: Lisa Calder