Publication: Between-trial heterogeneity in ARDS research
Issued Date
2021-04-01
Resource Type
ISSN
14321238
03424642
03424642
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2-s2.0-85102386532
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Mahidol University
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SCOPUS
Bibliographic Citation
Intensive Care Medicine. Vol.47, No.4 (2021), 422-434
Suggested Citation
J. Juschten, P. R. Tuinman, T. Guo, N. P. Juffermans, M. J. Schultz, S. A. Loer, A. R.J. Girbes, H. J. de Grooth Between-trial heterogeneity in ARDS research. Intensive Care Medicine. Vol.47, No.4 (2021), 422-434. doi:10.1007/s00134-021-06370-w Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/78316
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Title
Between-trial heterogeneity in ARDS research
Abstract
Purpose: Most 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. Methods: A 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. Results: In 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 < 0.0001). Reported baseline patient characteristics explained some of the outcome heterogeneity, but only six trials (9%) reported all four independently predictive variables (mean age, mean lung injury score, mean plateau pressure and mean arterial pH). The 28-day control group mortality adjusted for patient characteristics (i.e. the residual heterogeneity) ranged from 18 to 45%. Trials with significant benefit in the primary outcome reported a higher control group mortality than trials with an indeterminate outcome or harm (mean 28-day control group mortality: 44% vs. 28%; p = 0.001). Conclusion: Among 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.