Methodological review reveals unrealistic treatment effect assumptions in critical care randomized trials, highlighting systematic flaws in statistical power and outcome design.
ICU-based RCTs are commonly negative and powered to identify what appear to be unrealistic treatment effects, particularly when using mortality as the primary outcome. Additional concerns include a lack of standardized methods for assessing common outcomes, unclear justifications for statistical power calculations, insufficient patient accrual, and incorrect predictions of baseline event rates.
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Harhay et al. (2014) studied this question.
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