How outcomes are defined in clinical trials of mechanically ventilated adults and children

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.

Contributors

Blackwood, B. Clarke, M. McAuley, D. F. McGuigan, P. J. Marshall, J. C. Rose, L.

Publication

Journal: Am J Respir Crit Care Med
Volume: 189
Issue: 8
Pages: 886 - 93
Year: 2014
DOI: 10.1164/rccm.201309-1645PP

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s): Not stated


Health Area

Disease Category: Lungs & airways

Disease Name: Mechanical ventilation

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Mechanical ventilation

Stakeholders Involved

- Not Specified

Study Type

- Commentary
- Definition
- Overview of literature

Method(s)

- Literature review