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June 23/30, 2004

Hypertonic Saline for Prehospital Treatment of Traumatic Brain Injury—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(24):2943-2944. doi:10.1001/jama.291.24.2944-b

In Reply: Dr Zygun notes that we used a 1-point change in the GOSE as our primary outcome measure and that our trial had 80% power to identify this change but was underpowered for an alternative outcome measure, the proportion of patients with favorable outcomes. We chose the GOSE at 6 months because it is the most accepted measure of outcome for clinical trials in traumatic brain injury (TBI).1 An increase in the number of survivors with severe disability would be as important to detect as an increase in the number of good outcomes. Using the proportion of favorable outcomes in our study (38%) rather than that of Clifton et al (43%),2 a randomized trial of more than 750 patients would have been required to exclude a change in favorable outcomes of 10% (80% power), would have taken 10 years and would not have been feasible. We believe that our study provides useful information about the proportion of favorable outcomes at 6 months. These were virtually identical—38.1% for patients treated with hypertonic saline (HTS) and 38.9% Ringer's lactate solution, the control group, and do not suggest that HTS improves favorable outcomes.

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