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- Title
Exploration of alive-and-ventilator free days as an outcome measure for clinical trials of Resuscitative interventions.
- Authors
Moskowitz, Ari; Xie, Xianhong; Gong, Michelle Ng; Wang, Henry E.; Andrea, Luke; Lo, Yungtai; Kim, Mimi
- Abstract
Background: Outcome selection is a critically important aspect of clinical trial design. Alive-and-ventilator free days is an outcome measure commonly used in critical care clinical trials, but has not been fully explored in resuscitation science. Methods: A simulation study was performed to explore approaches to the definition and analysis of alive-and-ventilator free days in cardiac arrest populations. Data from an in-hospital cardiac arrest observational cohort and from the Pragmatic Airway Resuscitation Trial were used to inform and conduct the simulations and validate approaches to alive-and-ventilator free days measurement and analysis. Findings: Alive-and-ventilator-free days is a flexible outcome measure in cardiac arrest populations. An approach to alive-and-ventilator free days that assigns -1 days when return of spontaneous circulation is not achieved provides a wider distribution of the outcome and improves statistical power. The optimal approach to the analysis of alive-and-ventilator free days varies based on the expected impact of the intervention under study on rates of return of spontaneous circulation, survival, and ventilator-free survival. Conclusions: Alive-and-ventilator free days adds to the armamentarium of clinical trialists in the field of resuscitation science.
- Subjects
RETURN of spontaneous circulation; CARDIAC arrest; EXPERIMENTAL design; STATISTICAL power analysis; CRITICAL care medicine
- Publication
PLoS ONE, 2024, Vol 19, Issue 7, p1
- ISSN
1932-6203
- Publication type
Article
- DOI
10.1371/journal.pone.0308033