Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34403
Title: Protocol and statistical analysis plan for the phase 3 randomised controlled Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial.
Austin Authors: Presneill, Jeffrey J;Bellomo, Rinaldo ;Brickell, Kathy;Buhr, Heidi;Gabbe, Belinda J;Gould, Doug W;Harrold, Meg;Higgins, Alisa M;Hurford, Sally;Iwashyna, Theodore;Neto, Ary Serpa;Nichol, Alistair;Schaller, Stefan J;Sivasuthan, Janani;Tipping, Claire;Webb, Steven;Young, Paul;Hodgson, Carol L
Affiliation: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Department of Critical Care, University of Melbourne and Royal Melbourne Hospital, Melbourne, VIC, Australia.
Intensive Care
University College Dublin Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.
Royal Prince Alfred Hospital, Sydney, NSW, Australia.
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Intensive Care National Audit and Research Centre, London, UK.
Curtin University, Perth, WA, Australia.;Royal Perth Hospital, Perth, WA, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.;VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;University College Dublin Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.
Department of Anesthesiology, Division of Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Humboldt Universität zu Berlin and Freie Universität Berlin, Berlin, Germany.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Department of Physiotherapy, Alfred Health, Melbourne, VIC, Australia.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.;St John of God Subiaco Hospital, Perth, WA, Australia.
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.;VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA.;Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
Department of Critical Care, University of Melbourne and Royal Melbourne Hospital, Melbourne, VIC, Australia.;Department of Physiotherapy, Alfred Health, Melbourne, VIC, Australia.
Issue Date: 6-Sep-2021
Date: 2023
Publication information: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine 2021-09-06; 23(3)
Abstract: Objective: To describe the protocol and statistical analysis plan for the Treatment of Invasively Ventilated Adults with Early Activity and Mobilisation (TEAM III) trial. Design: An international, multicentre, parallel-group, randomised controlled phase 3 trial. Setting: Intensive care units (ICUs) in Australia, New Zealand, Germany, Ireland, the United Kingdom and Brazil. Patients: 750 adult patients expected to receive mechanical ventilation for more than 48 hours. Interventions: Early activity and mobilisation delivered to critically ill patients in an ICU for up to 28 days compared with standard care. Main outcome measures: The primary outcome is the number of days alive and out of hospital at 180 days after randomisation. Secondary outcomes include ICU-free days, ventilator-free days, delirium-free days, all-cause mortality at 28 and 180 days after randomisation, and functional outcome at 180 days after randomisation. Results: Recruitment at 46 research sites passed 576 patients in March 2021. Final collection of all 180-day outcome data for the target of 750 patients is anticipated by May 2022. Conclusions: Consistent with international guidelines, a detailed protocol and prospective analysis plan has been developed for the TEAM III trial. This plan specifies the statistical models for evaluating primary and secondary outcomes, defines covariates for adjusted analyses, and defines methods for exploratory analyses. Application of this protocol and statistical analysis plan to the forthcoming TEAM III trial will facilitate unbiased analyses of the clinical data collected. Trial registration:ClinicalTrials.gov identifier NCT03133377.
URI: https://ahro.austin.org.au/austinjspui/handle/1/34403
DOI: 10.51893/2021.3.OA3
ORCID: 
Journal: Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine
Start page: 262
End page: 272
PubMed URL: 38046085
Type: Journal Article
Appears in Collections:Journal articles

Show full item record

Page view(s)

10
checked on Apr 12, 2024

Google ScholarTM

Check


Items in AHRO are protected by copyright, with all rights reserved, unless otherwise indicated.