Journal Club Summary
Methodology Score: 4/5
Usefulness Score: 2/5
Wright DW, et al.; NETT Investigators. N Engl J Med. 2014 Dec 25;371(26):2457-66
A Clinical Trial of Progesterone for Severe Traumatic Brain Injury
Skolnick BE, et al; SYNAPSE Trial Investigators.
N Engl J Med 2014; 371:2467-2476
Progesterone for Traumatic Brain Injury — Resisting the Sirens’ Song
Lee H. Schwamm, M.D.
N Engl J Med 2014; 371:2522-2523
This is a large well conducted multicentre randomized control trial demonstrated no benefit with early administration of IV progesterone to traumatic brain injury patients ( GCS 4-12) within 4hrs of injury. JC attendees felt that as progesterone is not a regular intervention for traumatic brain injury, the trial would have little impact on their clinical practice.
By: Dr. Robert Ohle
(Presented January 2015)
Epi lesson: Adjustment Analyses in Randomized Trials
Clinical trials depend upon random allocation to ensure good balance of important baseline characteristics and thus allow a fair comparison between study arms, usually by unadjusted statistical analyses. Commonly, additional secondary analyses will adjust for all important measured covariates using multivariate techniques like logistic regression. These usually confirm the findings of the primary analyses but can only be considered hypothesis generating when the secondary analyses results are different.
By: Dr. Ian Stiell