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 (...) in a low-resource setting with the Ottawa Statement; to identify ethical issues in the design or conduct of the trial not captured adequately and to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; the classification of lay health workers who deliver study interventions as health providers or research participants; the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; the timing of gatekeeper engagement, particularly when researchers face funding constraints; providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and defining vulnerable participants needing protection in low-resource settings. (shrink)

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 (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Background This study assessed patient perceptions of the Physician Payments Sunshine Act and opinions toward physicians who receive gifts and/or payments from pharmaceutical or medical device companies. Methods During their office visit, patients attending different specialty clinics volunteered to complete our survey. The survey asks if the patient knows what the Sunshine Act is, then asks questions on 5-point response scales to assess the patient's opinions toward physicians who receive compensation from companies, their self-rated knowledge of physician compensation, and how (...) they believe this compensation affects the cost of care. Results Over 13 months, 523 responses were collected: 8.6% of patients reported having knowledge of the Sunshine Act, 56.8% rated their knowledge of physician compensations as “poor,” and 67.1% agreed with the statement that patients should be aware of the compensation physicians receive. When asked how their opinion toward their physician would change if they learned the physician received free meals or gifts from companies, 58.9% replied “not at all,” and 36.11% of patients did not believe their cost of care would increase if their physician received compensation from companies. Conclusions Most patients were unfamiliar with the Sunshine Act, and believe their knowledge of physician compensation is poor. Over half of the respondents would not change their opinion of their physician based on knowledge of their physician receiving payments/gifts from companies, and over one-third of respondents did not believe such compensation increased the cost of care. The majority of respondents agreed that patients should be aware of payments/gifts to physicians. (shrink)

Spinoza and modern thought, by Lawson P. Chambers.-- Existence and value, by George R. Dodson.-- The realm of necessity, by Charles E. Cory.

Study of rationalism in Urdu literature.

Cette livraison de la revue Langages semble avoir un objectif éditorial officiel, affiché dans son titre, consistant à porter un regard réflexif et critique sur les apports et les limites des (grands) corpus à divers domaines de l’analyse linguistique, et un objectif profond, moins immédiatement perceptible mais sans doute premier dans l’esprit des coordinateurs et particulièrement de Marcel Cori, consistant à remettre à sa juste place la linguistique de corpus accusée d’avoir des ambitions h..

Analyticity, or the 'analytic/synthetic' distinction is one of the most important and controversial problems in contemporary philosophy. It is also essential to understanding many developments in logic, philosophy of language, epistemology and metaphysics. In this outstanding introduction to analyticity Cory Juhl and Eric Loomis cover the following key topics: The origins of analyticity in the philosophy of Hume and Kant Carnap's arguments concerning analyticity in the early twentieth century Quine's famous objections to analyticity in his classic 'Two Dogmas of (...) Empiricism' essay The relationship between analyticity and central issues in metaphysics, such as ontology The relationship between analyticity and epistemology Analyticity in the context of the current debates in philosophy, including mathematics and ontology Throughout the book the authors show how many philosophical controversies hinge on the problem of analyticity. Additional features include chapter summaries, annotated further reading and a glossary of technical terms making the book ideal to those coming to the problem for the first time. (shrink)

Festschrift volume to K. Ramakrishna Rao, Indian psychologist, philosopher and educationist; contributed articles.

Courtesy of its free energy formulation, the hierarchical predictive processing theory of the brain (PTB) is often claimed to be a grand unifying theory. To test this claim, we examine a central case: activity of mesocorticolimbic dopaminergic (DA) systems. After reviewing the three most prominent hypotheses of DA activity—the anhedonia, incentive salience, and reward prediction error hypotheses—we conclude that the evidence currently vindicates explanatory pluralism. This vindication implies that the grand unifying claims of advocates of PTB are unwarranted. More generally, (...) we suggest that the form of scientific progress in the cognitive sciences is unlikely to be a single overarching grand unifying theory. (shrink)