Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30772
Title: Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic.
Austin Authors: Reid, Julie C;Molloy, Alex;Strong, Geoff;Kelly, Laurel;O'Grady, Heather;Cook, Deborah;Archambault, Patrick M;Ball, Ian;Berney, Susan C ;Burns, Karen E A;D'Aragon, Frederick;Duan, Erick;English, Shane W;Lamontagne, François;Pastva, Amy M;Rochwerg, Bram;Seely, Andrew J E;Serri, Karim;Tsang, Jennifer L Y;Verceles, Avelino C;Reeve, Brenda;Fox-Robichaud, Alison;Muscedere, John;Herridge, Margaret;Thabane, Lehana;Kho, Michelle E
Affiliation: Department of Physiotherapy, The University of Melbourne, Parkville, VIC, Australia
Physiotherapy
St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada..
School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada..
Department of Medicine, McMaster University, Hamilton, ON, Canada.. Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada..
Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Université Laval, Quebec, QC, Canada.. Department of Family Medicine and Emergency Medicine, Université Laval, Quebec, QC, Canada..
Department of Medicine and Department of Epidemiology and Biostatistics, Western University, London, ON, Canada..
Li Sha King Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada.
Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada.. Department of Anesthesiology, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada.. Centre de recherche du CHI de Sherbrooke, Sherbrooke, QC, Canada..
St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.. Department of Medicine, McMaster University, Hamilton, ON, Canada.. Division of Critical Care Medicine, Niagara Health, St. Catharines, ON, Canada..
Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada.. School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.. Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada..
Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada.. Centre de recherche du CHI de Sherbrooke, Sherbrooke, QC, Canada..
Departments of Medicine, Orthopedic Surgery and Population Health Sciences, Duke University School of Medicine, Durham, NC, USA..
Department of Medicine, McMaster University, Hamilton, ON, Canada.. Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada..
School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada..
Department of Medicine, Hôpital Sacré-Coeur de Montréal, Université de Montréal, Montreal, QC, Canada..
Department of Medicine, McMaster University, Hamilton, ON, Canada.. Division of Critical Care Medicine, Niagara Health, St. Catharines, ON, Canada..
Department of Medicine, University of Maryland Medical Centre, Midtown Campus, Baltimore, MD, USA.. Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, MD, USA..
Department of Medicine, Brantford General Hospital, Brantford, ON, Canada..
Department of Medicine, McMaster University, Hamilton, ON, Canada..
Department of Critical Care Medicine, Queen's University, Kingston, ON, Canada..
Toronto General Research Institute, University Health Network, Toronto, ON, Canada..
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.. Research Institute of St. Joseph's, Hamilton, ON, Canada..
St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.. School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada..
Issue Date: 2-Sep-2022
metadata.dc.date: 2022
Publication information: Trials 2022; 23(1): 735
Abstract: The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) was forced to halt recruitment at all sites in March 2020, creating immediate challenges. We applied the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) statement as a framework to report the impact of the pandemic on CYCLE and describe our mitigation approaches. On March 23, 2020, the CYCLE Methods Centre distributed a standardized email to determine the number of patients still in-hospital and those requiring imminent 90-day endpoint assessments. We assessed protocol fidelity by documenting attempts to provide the in-hospital randomized intervention (cycling or routine physiotherapy) and collect the primary outcome (physical function 3-days post-ICU discharge) and 90-day outcomes. We advised sites to prioritize data for the study's primary outcome. We sought feedback on pandemic barriers related to trial procedures. Our main Methods Centre mitigation strategies included identifying patients at risk for protocol deviations, communicating early and frequently with sites, developing standardized internal tools focused on high-risk points in the protocol for monitoring patient progress, data entry, and validation, and providing guidance to conduct some research activities remotely. For study sites, our strategies included determining how institutional pandemic research policies applied to CYCLE, communicating with the Methods Centre about capacity to continue any part of the research, and developing contingency plans to ensure the protocol was delivered as intended. From 15 active sites (12 Canada, 2 US, 1 Australia), 5 patients were still receiving the study intervention in ICUs, 6 required primary outcomes, and 17 required 90-day assessments. With these mitigation strategies, we attempted 100% of ICU interventions, 83% of primary outcomes, and 100% of 90-day assessments per our protocol. We retained all enrolled patients with minimal missing data using several time-sensitive strategies. Although CONSERVE recommends reporting only major modifications incurred by extenuating circumstances, we suggest that it also provides a helpful framework for reporting mitigation strategies with the goal of improving research transparency and trial management. NCT03471247. Registered on March 20, 2018.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30772
DOI: 10.1186/s13063-022-06640-y
ORCID: http://orcid.org/0000-0002-1424-3105
PubMed URL: 36056378
Type: Journal Article
Subjects: Critical illness
Randomized controlled trials
Research design
Research personnel
Research report
Appears in Collections:Journal articles

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