A Core Outcome Set for Critical Care Ventilation Trials

Research output: Contribution to journalArticle

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.

LanguageEnglish
JournalCritical Care Medicine
Early online date25 Jul 2019
DOIs
Publication statusEarly online date - 25 Jul 2019

Fingerprint

Delphi Technique
Ventilation
Clinical Trials
Critical Care
Artificial Respiration
Outcome Assessment (Health Care)
Organizations
Allied Health Personnel
South Australia
South America
North America
Caregivers
Survivors
Length of Stay
Industry
Nursing
Quality of Life
Research Personnel
Delivery of Health Care
Physicians

Cite this

@article{542a913d2eb34c069e65f05b3c0c36d1,
title = "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.",
author = "Bronagh Blackwood and Suzanne Ringrow and Mike Clarke and Marshall, {John C} and Bronwen Connolly and Louise Rose and McAuley, {Daniel F}",
year = "2019",
month = "7",
day = "25",
doi = "10.1097/CCM.0000000000003904",
language = "English",
journal = "Critical Care Medicine",
issn = "0090-3493",
publisher = "Lippincott Williams and Wilkins",

}

TY - JOUR

T1 - A Core Outcome Set for Critical Care Ventilation Trials

AU - Blackwood, Bronagh

AU - Ringrow, Suzanne

AU - Clarke, Mike

AU - Marshall, John C

AU - Connolly, Bronwen

AU - Rose, Louise

AU - McAuley, Daniel F

PY - 2019/7/25

Y1 - 2019/7/25

N2 - 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.

AB - 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.

U2 - 10.1097/CCM.0000000000003904

DO - 10.1097/CCM.0000000000003904

M3 - Article

JO - Critical Care Medicine

T2 - Critical Care Medicine

JF - Critical Care Medicine

SN - 0090-3493

ER -