Hypothetical scenarios evaluated.
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https://figshare.com/articles/dataset/Hypothetical_scenarios_evaluated_/26415946
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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.
创建时间:
2024-07-31



