by
Blackwood, Bronagh; Ringrow, Suzanne; Clarke, Mike; Marshall, John C.;
Connolly, Bronwen; Rose, Louise; McAuley, Daniel F
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.
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