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Jamie Brehaut [8]Jamie C. Brehaut [7]
  1. Does clinical equipoise apply to cluster randomized trials in health research?Ariella Binik, Charles Weijer, Andrew McRae, Jeremy Grimshaw, Monica Taljaard, Robert Boruch, Jamie Brehaut, Allan Donner, Martin Eccles, Antonio Gallo, Raphael Saginur & Merrick Zwarenstein - 2011 - Trials 12.
     
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  2. Ethical Issues Posed by Cluster Randomized Trials in Health Research.Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Andrew D. McRae & Ray Saginur - 2011 - Trials 1 (12):100.
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  3.  27
    An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled Trial.Austin R. Horn, Charles Weijer, Jeremy Grimshaw, Jamie Brehaut, Dean Fergusson, Cory E. Goldstein & Monica Taljaard - 2018 - Kennedy Institute of Ethics Journal 28 (1):85-118.
    Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria for (...)
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  4. When is informed consent required in cluster randomized trials in health research?Andrew D. McRae, Ariella Binik, Charles Weijer, Angela White, Jeremy M. Grimshaw, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Raphael Saginur, Merrick Zwarenstein & Monica Taljaard - 2011 - Trials 1 (12):202.
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  5.  21
    Informed consent in pragmatic trials: results from a survey of trials published 2014–2019.Jennifer Zhe Zhang, Stuart G. Nicholls, Kelly Carroll, Hayden Peter Nix, Cory E. Goldstein, Spencer Phillips Hey, Jamie C. Brehaut, Paul C. McLean, Charles Weijer, Dean A. Fergusson & Monica Taljaard - 2022 - Journal of Medical Ethics 49 (1):34-40.
    ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...)
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  6.  33
    Social science and ethics review: A question of practice not principle.Stuart G. Nicholls, Jamie Brehaut & Raphae Saginur - 2012 - Research Ethics 8 (2):71-78.
    In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes, and we concur, that there is a lack of empirical evidence as to the benefit of research ethics review.
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  7. Who is the research subject in cluster randomized trials in health research?Andrew D. McRae, Ariella Binik, Charles Weijer, Jeremy M. Grimshaw, Monica Taljaard, Robert Boruch, Jamie C. Brehaut, Allan Donner, Martin P. Eccles, Antonio Gallo, Ray Saginur & Merrick Zwarenstein - 2011 - Trials 1 (12):118.
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  8.  60
    Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):90.
    Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...)
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  9.  31
    Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providers.Austin R. Horn, Charles Weijer, Spencer Phillips Hey, Jamie Brehaut, Dean A. Fergusson, Cory E. Goldstein, Jeremy Grimshaw & Monica Taljaard - 2018 - Journal of Medical Ethics 44 (9):593-598.
    The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the (...)
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  10.  33
    Does Consent Form Follow Function?Charles Weijer, Jamie Brehaut & Cory E. Goldstein - 2017 - American Journal of Bioethics 17 (12):29-31.
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  11.  44
    Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics.Andrew McRae, Monica Taljaard, Charles Weijer, Carol Bennett, Zoe Skea, Robert Boruch, Jamie Brehaut, Martin Eccles, Jeremy Grimshaw & Allan Donner - 2013 - Journal of Medical Ethics 39 (2):119-124.
    Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as (...)
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  12. Accommodating quality and service improvement research within existing ethical principles.Cory E. Goldstein, Charles Weijer, Jamie Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn & Monica Taljaard - 2018 - Trials 19 (1):334.
    Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The (...)
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    What is in a Name? Parent, Professional and Policy-Maker Conceptions of Consent-Related Language in the Context of Newborn Screening.Stuart G. Nicholls, Holly Etchegary, Laure Tessier, Charlene Simmonds, Beth K. Potter, Jamie C. Brehaut, Daryl Pullman, Robin Z. Hayeems, Sari Zelenietz, Monica Lamoureux, Jennifer Milburn, Lesley Turner, Pranesh Chakraborty & Brenda J. Wilson - 2019 - Public Health Ethics 12 (2):158-175.
    Newborn bloodspot screening programs are some of the longest running population screening programs internationally. Debate continues regarding the need for parents to give consent to having their child screened. Little attention has been paid to how meanings of consent-related terminology vary among stakeholders and the implications of this for practice. We undertook semi-structured interviews with parents, healthcare professionals and policy decision makers in two Canadian provinces. Conceptions of consent-related terms revolved around seven factors within two broad domains, decision-making and information (...)
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  14.  44
    (1 other version)Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):14.
    Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four (...)
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