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Open Access 01-12-2015 | Study protocol

Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study

Authors: Bronagh Blackwood, Suzanne Ringrow, Mike Clarke, John Marshall, Louise Rose, Paula Williamson, Danny McAuley

Published in: Trials | Issue 1/2015

Abstract

Background

Among clinical trials of interventions that aim to modify time spent on mechanical ventilation for critically ill patients there is considerable inconsistency in chosen outcomes and how they are measured. The Core Outcomes in Ventilation Trials (COVenT) study aims to develop a set of core outcomes for use in future ventilation trials in mechanically ventilated adults and children.

Methods/design

We will use a mixed methods approach that incorporates a randomised trial nested within a Delphi study and a consensus meeting. Additionally, we will conduct an observational cohort study to evaluate uptake of the core outcome set in published studies at 5 and 10 years following core outcome set publication. The three-round online Delphi study will use a list of outcomes that have been reported previously in a review of ventilation trials. The Delphi panel will include a range of stakeholder groups including patient support groups. The panel will be randomised to one of three feedback methods to assess the impact of the feedback mechanism on subsequent ranking of outcomes. A final consensus meeting will be held with stakeholder representatives to review outcomes.

Discussion

The COVenT study aims to develop a core outcome set for ventilation trials in critical care, explore the best Delphi feedback mechanism for achieving consensus and determine if participation increases use of the core outcome set in the long term.

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Title: Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study
Authors: Bronagh Blackwood
Suzanne Ringrow
Mike Clarke
John Marshall
Louise Rose
Paula Williamson
Danny McAuley
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-015-0905-9

At a glance: The STEP trials

Springer Medicine

Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study

Abstract

Background

Methods/design

Discussion

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

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