Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome

DA Schoenfeld, GR Bernard - Critical care medicine, 2002 - journals.lww.com
Objective Trials of potential new therapies in acute lung injury are difficult and expensive to
conduct. This article is designed to determine the utility, behavior, and statistical properties
of a new primary end point for such trials, ventilator-free days, defined as days alive and free
from mechanical ventilation. Describing the nuances of this outcome measure is particularly
important because using it, while ignoring mortality, could result in misleading conclusions.
Design To develop a model for the duration of ventilation and mortality and fit the model by …