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  1.  1
    Ottawa Statement Does Not Impede Randomised Evaluation of Government Health Programmes.Charles Weijer & Monica Taljaard - 2020 - Journal of Medical Ethics 46 (1):31-33.
    In this issue of JME, Watson et al call for research evaluation of government health programmes and identify ethical guidance, including the Ottawa Statement on the ethical design and conduct of cluster randomised trials, as a hindrance. While cluster randomised trials of health programmes as a whole should be evaluated by research ethics committees, Watson et al argue that the health programme per se is not within the researcher’s control or responsibility and, thus, is out of scope for ethics review. (...)
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  2.  7
    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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  3. 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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  4. Development and Field Testing of a Tool to Elicit Women's Preferences Among Cervical Cancer Screening Modalities.Brianne Wood, Monica Taljaard, Ziad El‐Khatib, Susan McFaul, Ian D. Graham & Julian Little - 2019 - Journal of Evaluation in Clinical Practice 25 (6):1169-1181.
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  5. 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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  6. 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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  7.  18
    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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  8.  17
    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):1-10.
    Background 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. Methods 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. Results Our (...)
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  9. 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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  10.  11
    Ethical Issues Raised by Cluster Randomised Trials Conducted in Low-Resource Settings: Identifying Gaps in the Ottawa Statement Through an Analysis of the PURE Malawi Trial.Tiwonge K. Mtande, Charles Weijer, Mina C. Hosseinipour, Monica Taljaard, Mitch Matoga, Cory E. Goldstein, Billy Nyambalo & Nora E. Rosenberg - 2019 - Journal of Medical Ethics 45 (6):388-393.
    The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster trial conducted (...)
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  11.  24
    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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  12.  2
    The Importance of Describing as Well as Defining Usual Care.Stuart G. Nicholls, Merrick Zwarenstein & Monica Taljaard - 2020 - American Journal of Bioethics 20 (1):56-58.
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  13.  19
    The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report.Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah Jl Edwards & Martin P. Eccles - 2014 - Research Ethics 10 (2):77-85.
    Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...)
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  14.  20
    Addition of Time‐Dependent Covariates to a Survival Model Significantly Improved Predictions for Daily Risk of Hospital Death.Jenna Wong, Monica Taljaard, Alan J. Forster, Gabriel J. Escobar & Carl van Walraven - 2013 - Journal of Evaluation in Clinical Practice 19 (2):351-357.
  15.  4
    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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