A Core Outcome Set for Critical Care Ventilation Trials

Objectives:
Our objective was to obtain international consensus on a set of core outcome measures that should be recorded in all clinical trials of interventions intended to modify the duration of ventilation for invasively mechanically ventilated patients in the ICU.

Design:
A two-stage consensus process was undertaken between December 2015 and January 2018. Stage 1 included an online three-round Delphi study and three consensus meetings. Stage 2 included three consensus meetings.

Setting:
The setting was international, including Europe, North and South America, Australia, Asia, and Africa.

Participants:
Organization members representing intensive care survivors and carers; nursing, allied health professionals, and critical care physicians; clinical trials groups and trial investigators; and industry.

Interventions:
None.

Measurements and Main Results:
Delphi study outcomes were scored by participants from one (least important) to nine (most important). Consensus criteria for including the outcome in the core set were more than 70% of responses rating the outcome above seven and not more than 15% rating the outcome less than 3. From 222 participants, 183 from 38 organizations in 27 countries contributed to the consensus process. Stage 1: Delphi response rates from 200 participants ranged from 89% to 90% across three rounds. Forty-seven outcomes were ranked as follows: 19 met consensus criteria for inclusion and were considered at three consensus meetings (33 participants). Six outcomes were agreed for the core set as follows: extubation, reintubation, duration of mechanical ventilation, length of stay, health-related quality of life, and mortality. Stage 2: Three consensus meetings (37 participants) agreed on the measures for each outcome.

Conclusions:
We used rigorous and well-established methods to develop a core outcome set for use in all clinical trials evaluating interventions intended to modify duration of mechanical ventilation. This core outcome set will inform the design of future trials in this field by strengthening methodological quality and improving comparability across trials.

Contributors

This study will be undertaken by Dr Suzanne Ringrow as part of a PhD programme at the School of Medicine, Dentistry and Biomedical Sciences in Queens University Belfast.
Principal Supervisor Dr Bronagh Blackwood – Queens University Belfast
Dr Dave Liu – University of Queensland, Brisbane
Prof Michael Reade – University of Queensland, Brisbane
Prof Danny McAuley – Queens University Belfast
Prof Mike Clarke - Queens University Belfast
Prof Tim Walsh – The University of Edinburgh

Publication

Journal: Critical care medicine
Volume: 47
Issue: 10
Pages: 1324 - 1331
Year: 2019
DOI: 10.1097/CCM.0000000000003904

Further Study Information

Current Stage: Withdrawn
Date: May 2017 - August 2017
Funding source(s): Supported, in part, by grant from the Department of Education and Learning (Northern Ireland) through a funded PhD studentship for Dr. Ringrow.


Health Area

Disease Category: Lungs & airways

Disease Name:

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- Pharmaceutical industry representatives
- Trialists

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Systematic review
- Delphi process

Design:
A two-stage consensus process was undertaken between December 2015 and January 2018. Stage 1 included an online three-round Delphi study and three consensus meetings. Stage 2 included three consensus meetings.

Setting:
The setting was international, including Europe, North and South America, Australia, Asia, and Africa.

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