A Core Outcome Set for Critical Care Ventilation Trials

Abstract

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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