Journal Club Summary
Landmark Series
Methodology Score: 4/5
Usefulness Score: 4/5
ProCESS Investigators
N Engl J Med. 2014 May 1;370(18):1683-93.
This large multicentre U.S. RCT of 1341 septic patients found no significant differences in mortality amongst the three arms of the study: 21.0% in the EGDT group, 18.2% in the protocol-based standard-therapy group, and 18.9% in the usual-care group. JC attendees appreciated that this study will not change practice at the TOH as it underscores that protocolized treatment has translated to a higher standard of care and thus reinforces our current management of septic patients with emphasis on early recognition, early antibiotics and early/adequate volume resuscitation.
By: Dr. Tamara McColl
Epi lesson: Contamination in Randomized Trials
This is a type of bias where there is a mixing of treatments between study groups such that the impact of the intervention is difficult to determine. This is most likely to occur in non-drug trials where the intervention cannot be blinded and relies upon physician involvement, e.g. choosing a treatment protocol. One increasingly popular solution to this problem is to randomize by ‘cluster’ e.g. by hospital site, rather by patient.
By: Dr. Ian Stiell
By: Dr. Ian Stiell
