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.
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
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.


CONCLUSIONS
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.
Centre for Infection and Immunity, Queen's University Belfast, Health Sciences Building, 97 Lisburn Road, Belfast, BT9 7AE, Northern Ireland. b.blackwood@qub.ac.uk.
Bronagh
B
Blackwood
Centre for Infection and Immunity, Queen's University Belfast, Health Sciences Building, 97 Lisburn Road, Belfast, BT9 7AE, Northern Ireland. sringrow01@qub.ac.uk.
Suzanne
S
Ringrow
Northern Ireland Network for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences, Block B, Royal Victoria Hospital, Belfast, BT12 6BA, Northern Ireland. m.clarke@qub.ac.uk.
Mike
M
Clarke
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada. marshallj@smh.ca.
John
J
Marshall
Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada. louise.rose@utoronto.ca.|Sunnybrook Health Sciences Centre, Toronto, ON, Canada. louise.rose@utoronto.ca.|Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada. louise.rose@utoronto.ca.|Provincial Centre of Weaning Excellence, Toronto East General Hospital, Toronto, ON, Canada. louise.rose@utoronto.ca.|West Park Healthcare Centre, Toronto, ON, Canada. louise.rose@utoronto.ca.
Louise
L
Rose
Department of Biostatistics, University of Liverpool, Shelley's Cottage, Brownlow Street, Liverpool, L69 3GS, UK. p.r.williamson@liverpool.ac.uk.
Paula
P
Williamson
Centre for Infection and Immunity, Queen's University Belfast, Health Sciences Building, 97 Lisburn Road, Belfast, BT9 7AE, Northern Ireland. d.f.mcauley@qub.ac.uk.|Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, BT12 6BA, Northern Ireland. d.f.mcauley@qub.ac.uk.
Danny
D
McAuley
D006801:Humans; D032921:Consensus; D003245:Consensus Statements as Topic; D016638:Critical Illness / Q000628:therapy; D003697:Delphi Technique; D012107:Research Design; D012121:Respiration, Artificial; D013997:Time Factors; D016896:Treatment Outcome; D064887:Observational Studies as Topic; D016032:Randomized Controlled Trials as Topic