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60Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocolBMC Medical Ethics 19 (1): 90. 2018.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. I…Read more
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50Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation (review)BMC Medical Ethics 19 (1): 1-10. 2018.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, 3…Read more
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39Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristicsJournal of Medical Ethics 39 (2): 119-124. 2013.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 u…Read more
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35Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation (review)BMC Medical Ethics 19 (1): 14. 2018.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 inc…Read more
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34The Ottawa statement on the ethical design and conduct of cluster randomized trials: A short reportResearch Ethics 10 (2): 77-85. 2014.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 comm…Read more
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27Knowing the Difference: Feminist Perspectives in Epistemology Edited By Kathleen Lennon and Margaret Whitford Routledge,London 1994, 300 pp., £12.99(pb) £37.50(hb) (review)Philosophy 70 (271): 127-. 1995.
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25The potential influence of small group processes on guideline developmentJournal of Evaluation in Clinical Practice 7 (2): 165-173. 2001.
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21A recruitment strategy for cluster randomized trials in secondary care settingsJournal of Evaluation in Clinical Practice 6 (2): 185-192. 2000.
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19Impact of group structure and process on multidisciplinary evidence‐based guideline development: an observational studyJournal of Evaluation in Clinical Practice 8 (2): 145-153. 2002.
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17Developing clinically valid practice guidelinesJournal of Evaluation in Clinical Practice 1 (1): 37-48. 1995.
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16The Ottawa statement on the ethical design and conduct of cluster randomized trials: A short reportResearch Ethics 11 (1): 52-60. 2015.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 com…Read more
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15Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providersJournal of Medical Ethics 44 (9): 593-598. 2018.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 h…Read more
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15An Ethical Analysis of the SUPPORT Trial: Addressing Challenges Posed by a Pragmatic Comparative Effectiveness Randomized Controlled TrialKennedy Institute of Ethics Journal 28 (1): 85-118. 2018.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 framewor…Read more
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Accommodating quality and service improvement research within existing ethical principlesTrials 19 (1): 334. 2018.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…Read more
Areas of Interest
Philosophy of Mind |
20th Century Philosophy |