title: How outcomes are defined in clinical trials of mechanically ventilated adults and children.
abstract: Systematic reviews have considerable potential to provide evidence-based data to aid clinical decision-making. However, there is growing recognition that trials involving mechanical ventilation lack consistency in the definition and measurement of ventilation outcomes, creating difficulties in combining data for meta-analyses. To address the inconsistency in outcome definitions, international standards for trial registration and clinical trial protocols published recommendations, effectively setting the "gold standard" for reporting trial outcomes. In this Critical Care Perspective, we review the problems resulting from inconsistent outcome definitions and inconsistent reporting of outcomes (outcome sets). We present data highlighting the variability of the most commonly reported ventilation outcome definitions. Ventilation outcomes reported in trials over the last 6 years typically fall into four domains: measures of ventilator dependence; adverse outcomes; mortality; and resource use. We highlight the need, first, for agreement on outcome definitions and, second, for a minimum core outcome set for trials involving mechanical ventilation. A minimum core outcome set would not restrict trialists from measuring additional outcomes, but would overcome problems of variability in outcome selection, measurement, and reporting, thereby enhancing comparisons across trials.
authors: 1 Centre for Infection and Immunity and.
authors: Bronagh
authors: B
authors: Blackwood
authors: Mike
authors: M
authors: Clarke
authors: Danny F
authors: DF
authors: McAuley
authors: Peter J
authors: PJ
authors: McGuigan
authors: John C
authors: JC
authors: Marshall
authors: Louise
authors: L
authors: Rose
mesh_terms: D000328:Adult; D002648:Child; D003422:Critical Care; D019317:Evidence-Based Medicine; D006801:Humans; D017063:Outcome Assessment, Health Care; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012121:Respiration, Artificial / Q000379:methods; D016896:Treatment Outcome