Enhancing the informed consent process for critical care research: Strategies from a thromboprophylaxis trial
Orla Smith,Ellen McDonald,Nicole Zytaruk,Denise Foster,Andrea Matte,Suzie Fleury,Katie Krause,Tracey McArdle,Yoanna Skrobik,Deborah J. Cook +9 more
TLDR
13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies are identified.About:
This article is published in Intensive and Critical Care Nursing.The article was published on 2013-12-01 and is currently open access. It has received 27 citations till now. The article focuses on the topics: Informed consent & Intensive care.read more
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Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.
TL;DR: Alternative procedures such as deferred or waived consent have been used in the past and may be suitable alternatives in certain conditions, provided appropriate approval from institutional review boards (IRBs) can be obtained, in accordance with existing legislation.
Journal ArticleDOI
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial
Nick Daneman,Asgar H. Rishu,Wei Xiong,Sean M. Bagshaw,Deborah J. Cook,Peter Dodek,Richard Hall,Anand Kumar,Francois Lamontagne,François Lauzier,John C. Marshall,Claudio Martin,Lauralyn McIntyre,John Muscedere,Steven Reynolds,Henry T. Stelfox,Robert A. Fowler +16 more
TL;DR: The BALANCE pilot trial will inform the design and execution of the subsequent BALANCE main trial, which will evaluate shorter versus longer duration treatment for bacteremia in critically ill patients, and thereby provide an evidence basis for treatment duration decisions for these infections.
Journal ArticleDOI
Clonidine in the sedation of mechanically ventilated children: a pilot randomized trial.
Mark Duffett,Karen Choong,Jennifer Foster,Ji Cheng,Maureen O. Meade,Kusum Menon,Deborah J. Cook +6 more
TL;DR: This pilot trial demonstrated feasibility of a larger randomized controlled trial, and recommends that future trials capitalize on the experience gained and use these results to design a larger trial focusing on clinically important outcomes.
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Processes of consent in research for adults with impaired mental capacity nearing the end of life: systematic review and transparent expert consultation (MORECare_Capacity statement).
Catherine J Evans,Emel Yorganci,Penney Lewis,Jonathan Koffman,K. Stone,India Tunnard,Bee Wee,William Bernal,Matthew Hotopf,Irene J Higginson +9 more
TL;DR: The MORECare_C statement provides much needed guidance to enrol individuals with serious illness in research and demonstrates the ethical imperative and processes of recruiting adults across the capacity spectrum in varying populations and settings.
Journal ArticleDOI
Evaluating probiotics for the prevention of ventilator-associated pneumonia: a randomised placebo-controlled multicentre trial protocol and statistical analysis plan for PROSPECT.
Jennie Johnstone,Diane Heels-Ansdell,Lehana Thabane,Maureen O. Meade,John C. Marshall,François Lauzier,Erick Duan,Nicole Zytaruk,Daphnée Lamarche,Michael G. Surette,Deborah J. Cook +10 more
TL;DR: The Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT) aims to determine the impact of the probiotic Lactobacillus rhamnosus GG on VAP and other clinically important outcomes in critically ill adults.
References
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Intensive versus conventional glucose control in critically ill patients.
Nice-Sugar Study Investigators,Dean R. Chittock,Steve Su,D. Blair,Denise Foster,Rinaldo Bellomo,Deborah J. Cook,Vinay Dhingra,Peter Dodek,Paul C. Hébert,William R. Henderson,Stephane Heritier,Daren K. Heyland,Colin McArthur,Ellen McDonald,Imogen Mitchell,Robyn Norton,J. Potter,Bruce G. Robinson,Juan J. Ronco +19 more
TL;DR: In this large, international, randomized trial, it was found that intensive glucose control increased mortality among adults in the ICU: a blood glucose target of 180 mg or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg perDeciliter.
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Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock
Djillali Annane,Véronique Sébille,C. Charpentier,Pierre-Edouard Bollaert,Bruno François,Jean-Michel Korach,Gilles Capellier,Yves Cohen,Elie Azoulay,Gilles Troché,Philippe Chaumet-Riffaut,Eric Bellissant +11 more
TL;DR: In this trial, a 7-day treatment with low doses of hydrocortisone and fludrocort isone significantly reduced the risk of death in patients with septic shock and relative adrenal insufficiency without increasing adverse events.
Journal ArticleDOI
Risk of Post-traumatic Stress Symptoms in Family Members of Intensive Care Unit Patients
Elie Azoulay,Frédéric Pochard,Nancy Kentish-Barnes,Sylvie Chevret,Jerome Aboab,Christophe Adrie,Djilali Annane,Gérard Bleichner,Pierre Edouard Bollaert,Michael Darmon,Thomas Fassier,Richard Galliot,Maité Garrouste-Orgeas,Cyril Goulenok,Dany Goldgran-Toledano,Jan Hayon,Mercé Jourdain,Michel Kaidomar,Christian Laplace,Jérôme Larché,Jerome Liotier,Laurent Papazian,Catherine Poisson,Jean Reignier,Fayçal Saidi,Benoît Schlemmer +25 more
TL;DR: Post-traumatic stress reaction consistent with a high risk of PTSD is common in family members of ICU patients and is the rule among those who share in end-of-life decisions.
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Drotrecogin alfa (activated) in adults with septic shock
V. Marco Ranieri,B. Taylor Thompson,Philip S. Barie,Jean-François Dhainaut,Ivor S. Douglas,Simon Finfer,Simon Finfer,Bengt Gårdlund,John C. Marshall,Andrew Rhodes,Antonio Artigas,Didier Payen,Jyrki Tenhunen,Hussein R. Al-Khalidi,Vivian P. Thompson,Jonathan Janes,William L. Macias,Burkhard Vangerow,Mark D. Williams +18 more
TL;DR: DrotAA did not significantly reduce mortality at 28 or 90 days, as compared with placebo, in patients with septic shock, and rates of death at 28 and 90 days were not significantly different in other predefined subgroups, including patients at increased risk for death.