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Effect of Prehospital Induction of Mild Hypothermia on Survival and Neurological Status Among Adults With Cardiac Arrest A Randomized Clinical Trial

Methodology Score: 3/5                   
Usefulness Score: 2/5

Kim F, et al.
JAMA. 2014 Jan 1;311(1):45-52.

Editorial:
Randomized Clinical Trial Progress to Inform Care for Out-of-Hospital Cardiac Arrest
Granger CB, Becker LB
JAMA. 2014;311(1):31-32

This randomized clinical trial found that early pre-hospital cooling with 2 litres of IV Normal Saline at 4 degrees Celsius did not improve survival (non-VF P = 0.30; VF, P = 0.69) or neurological outcome (non-VF, P = 0.74; VF, P = 0.59) in patients with ROSC and led to higher incidence of pulmonary edema (P < 0.001) and re-arrest (P = 0.008). JC attendees identified concerns with pre-randomization selection bias; however, the study correlates with the body of evidence that suggests that pre-hospital cooling with IV NS is not recommended. 
By: Dr. Nicholas Clarridge


Epi Lesson: Selection Bias and Randomization

Even though a clinical trial is randomized, this does not mean it cannot be subject to selection bias. Always look at the study flow figure (generally figure 1) to determine how many eligible patients were not included then assess whether the authors reasonably explain why these eligible but excluded patients were not systematically different from those who were randomized. 
By: Dr. Lisa Calder

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