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PurposeMost randomized controlled trials (RCTs) in patients with acute respiratory distress syndrome (ARDS) revealed indeterminate or conflicting study results. We aimed to systematically evaluate between-trial heterogeneity in reporting standards and trial outcome.MethodsA systematic review of RCTs published between 2000 and 2019 was performed including adult ARDS patients receiving lung-protective ventilation. A random-effects meta-regression model was applied to quantify heterogeneity (non-random variability) and to evaluate trial and patient characteristics as sources of heterogeneity.ResultsIn total, 67 RCTs were included. The 28-day control-group mortality rate ranged from 10 to 67% with large non-random heterogeneity (I2 = 88%, p ConclusionAmong ARDS RCTs in the lung-protective ventilation era, there was large variability in the description of baseline characteristics and significant unexplainable heterogeneity in 28-day control group mortality. These findings signify problems with the generalizability of ARDS research and underline the urgent need for standardized reporting of trial and baseline characteristics.

Original publication




Journal article


Intensive care medicine

Publication Date





422 - 434


Department of Intensive Care, Amsterdam UMC, Vrije Universiteit Amsterdam, De Boelelaan 1117, mail stop ZH 7D-172, 1081HV, Amsterdam, The Netherlands.


Humans, Respiration, Artificial, Adult, Respiratory Distress Syndrome