The randomized controlled trial is seen by many as the summit of evidence-based medicine, yet, in the intensive care unit, randomized controlled trials can be challenging to conduct, and results are often difficult to interpret and apply. Many randomized controlled trials in intensive care patients have not demonstrated beneficial effects of the intervention under investigation often despite good preclinical and even previous randomized controlled trial evidence. There are many reasons for these negative results including problems with timing, end point selection, and heterogeneous populations. In this article, we will discuss the limitations of randomized controlled trials in the intensive care unit population and highlight the importance of considering other study designs in the challenging intensive care unit environment.
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