Published in:
01-01-2015 | Editorial
Mortality is the only relevant outcome in ARDS: yes
Author:
Marc Moss
Published in:
Intensive Care Medicine
|
Issue 1/2015
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Excerpt
When designing a clinical trial, investigators make several fundamental decisions that impact the feasibility to conduct the study in a timely fashion, and the significance and generalizability of the results. In 2009, the United States National Heart, Lung, and Blood Institute (NHLBI) convened a workshop entitled “Beyond Mortality: Future Clinical Research in Acute Lung Injury” to examine specific issues related to the conduct of clinical trials including the selection of outcome variables [
1]. Relevant to this pro-con debate, the panel of experts concluded that mortality continues to be the most critical outcome in ARDS clinical trials [
1]. Despite these recommendations, many ARDS clinical trials continue to use non-mortality variables as their primary outcome. In this pro/con debate, I present four reasons and provide supporting evidence for why mortality should be the preferred primary outcome variable for ARDS clinical trials. …