Journal Club Summary
Methodology Score: 3.5/5
Usefulness Score: 2.5/5
Armstrong PW, et al. STREAM Investigative Team.
N Engl J Med. 2013 Apr 11;368(15):1379-87
This open-label, prospective, randomized, parallel, comparative, international multicenter trial compared the efficacy and safety of pre-hospital fibrinolysis versus primary PCI. The composite outcome occurred 116 of 939 patients in the fibrinolysis group and 135 of 943 in the primary PCI group. (RR 0.86; 95% confidence interval, 0.68 to 1.09; P = 0.21). The group applauded the author’s amendment to the protocol to address increased rates of significant hemorrhage but the efficacy of half dose fibrinolysis in the elderly still needs further study.
By: Dr. Nathan Hecht
(Presented May 2013)
Epi lesson – Adjusting for Unbalanced Randomization
The goal of randomization is to have balanced known and unknown important clinical characteristics between the treatment and control groups. On occasion, after randomization there will be significant differences between both groups which could influence the main result. One way to deal with this is to conduct an adjusted analysis where you repeat your analysis but stratify by the factor which is different. If there is any significant change in the main result, this is an important indicator of bias.
By: Dr. Lisa Calder