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. 2019 Oct;47(10):1324-1331.
doi: 10.1097/CCM.0000000000003904.

A Core Outcome Set for Critical Care Ventilation Trials

Bronagh Blackwood  1 , Suzanne Ringrow  1 , Mike Clarke  2 , John C Marshall  3 , Bronwen Connolly  4   5   6 , Louise Rose  4   7   8   9 , Daniel F McAuley  1   10
Affiliations

A Core Outcome Set for Critical Care Ventilation Trials

Bronagh Blackwood et al. Crit Care Med. 2019 Oct.

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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Figures

Figure 1.
Figure 1.
Core Outcomes in Ventilation Trials study flow diagram.
See this image and copyright information in PMC

References

    1. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: Addressing inaccessible research. Lancet 2014; 383:257–266 - PMC - PubMed
    1. Blackwood B, Murray M, Chisakuta A, et al. Protocolized versus non-protocolized weaning for reducing the duration of invasive mechanical ventilation in critically ill paediatric patients. Cochrane Database Syst Rev 2013; (7):CD009082 - PMC - PubMed
    1. Blackwood B, Burns KEA, Cardwell CR, et al. Protocolized versus non-protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients. Cochrane Database Syst Rev 2010; (5):CD006904. - PubMed
    1. Rose L, Schultz MJ, Cardwell CR, et al. Automated versus non-automated weaning for reducing the duration of mechanical ventilation for critically ill adults and children. Cochrane Database Syst Rev 2014; (6):CD009235. - PMC - PubMed
    1. Blackwood B, Clarke M, McAuley DF, et al. How outcomes are defined in clinical trials of mechanically ventilated adults and children. Am J Respir Crit Care Med 2014; 189:886–893 - PubMed

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