Admission to the intensive care unit (ICU) represents a time when patients and families are at high risk for a variety of poor outcomes, including physical and psychological morbidity. However, studies of interventions to improve these outcomes have resulted in high-profile, high-quality clinical trials that show no statistically significant benefit of the intervention (ie, trials with “negative” or “null” results). Several reasons may explain the preponderance of these negative trials.1 First, critical care often involves the care of patients with complex disease, making successful interventions difficult to achieve. Second, relatively few interventions in the ICU have been preceded by high-quality preliminary phase 1 and 2 trials. Third, some trials conducted in critically ill patients are limited by sample sizes that may be too small to detect potentially important outcomes with small effect sizes. Trials to mitigate the effects of the psychological “postintensive care syndromes” are no exception.2,3 However, it is important to highlight that negative trials can be valuable for 2 reasons. These trials can help deimplement (or not implement) ineffective interventions. Perhaps more important, lessons from these trials can help identify and develop new interventions that will improve patient outcomes.
Kross EK, Pollak KI, Curtis JR. Addressing the Psychological Symptoms of Critical Illness: The Importance of “Negative” Trials in Guiding Next Steps. JAMA. 2019;321(7):649–650. doi:10.1001/jama.2019.0072
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