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)

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 (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

In these essays, we are concerned with virtue in journalism and the media but are mindful of the tension between the commercial foundations of publishing and broadcasting, on the one hand, and journalism's democratic obligations on the other. Adam outlines, first, a moral vision of journalism focusing on individualistic concepts of authorship and craft. Next, Craft attempts to bridge individual and organizational concerns by examining the obligations of organizations to the individuals working within them. Finally, Cohen discusses the importance of (...) resisting the powerful corporate logic that pervades the news media in the United States and calls on journalists to be courageous. (shrink)

This article aims to explicate the concept of emotional sharing against the background of interactive and situated approaches to affectivity, and to contextualize emotional sharing within the broader context of emotion research. It brings together research on situated affectivity with the debate on collective emotion. Emotional sharing is defined via four requirements and distinguished from other phenomena in the broad field of collective emotion, especially from mechanisms of emotional convergence and other forms of affective we-experience. The paper makes use of (...) the recently proposed concepts of affective scaffolding and affective arrangement to explore how emotional sharing is always enacted in sociorelational dynamics and embedded in socio-material contexts which enable, shape, and modulate the unfolding of emotional sharing and regulate who is likely to participate. (shrink)

Anastasia G. Yangaki Amphores crétoises : le cas d'Éleutherna p. 503-523 L'étude des amphores crétoises de la période paléochrétienne mises au jour sur le site d'Éleutherna, dans la région de Mylopotamos, enrichit considérablement notre connaissance des amphores de production crétoise identifiées à la suite des recherches récentes sur plusieurs sites de la Méditerranée. Cet article tend à préciser la datation précédemment proposée pour certains types déjà connus. Il présente un groupe uniforme d'amphores à l'intérieur du type initial, produit par un (...) nouvel atelier, et révèle plusieurs types nouveaux à Éleutherna, utilisés surtout à la fin de la période protobyzantine et même au cours du VIIIe siècle ; parmi ces derniers, on signale les types qui imitent des formes d'amphores importées sur l'île. Des analyses chimiques ont permis d'ajouter le site d'Éleutherna ou la région de Mylopotamos au nombre des centres de fabrication d'amphores crétoises. (shrink)

Markov, A. A. On constructive mathematics.--Ceĭtin, G. S. Mean value theorems in constructive analysis.--Zaslavskiĭ, I. D. and Ceĭtlin, G. S. On singular coverings and properties of constructive functions connected with them.--Maslov, S. Ju. Certain properties of E. L. Post's apparatus of canonical calculi.--Zaslavskiĭ, I. D. Graph schemes with memory.

Excerpt from Zur Psychologie des Asthetischen Genusses Die erste Erfahrung, auf der uberhaupt die Existenz berechtigung einer Wissenschaft wie der Asthetik beruht, ist die, da durch Einwirkung gewisser Objekte auf unsere Sinne ein Wohlgefallen in uns erzeugt wird, das wir unmittelbar und mit ziemlicher Sicherheit von allen anderen Arten des Wohlgefallens unterscheiden. Wenn wir versuchen, diesen zunachst nur gefiihlten Unterschied zu begrifi'licher Klarheit emporzuheben, so bemerken wir, da das asthetische Wohl gefallen durch zwei Eigenschaften charakterisiert und von allen anderen Arten (...) des Glucksgefiihls geschieden ist: erstens knupft es sich nicht an Elementarvorstellungen also ein fache Empfindungen sondern an Vorstellungskomplexe, und zweitens setzt es nicht die reale oder gedachte Erfullung einer zielsetzenden Tatigkeit voraus, sondern hat sein Ziel allein in sich selbst. Durch die erste Bestimmung unterscheidet es sich von sinnlichen Lustgefuhlen, durch die zweite von allen anderen Arten des Wohlgefallens, die wir aus leicht ersieht lichen Grunden als praktisch bezeichnen wollen. About the Publisher Forgotten Books publishes hundreds of thousands of rare and classic books. Find more at www.forgottenbooks.com This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works. (shrink)

Plutarch, in his work,_ Peri __Deisidaimon_ia_ __,_ presents a striking portrayal of superstition in the First Century. The Philosopher who also served for decades as a priest of Apollo portrays the pernicious effects of some supposed religious practices as worse than the outcome of atheism. His position constitutes a forceful explanation to ostensibly controversial socio-religious behaviours. This article discusses some of the priest’s concerns as well as his rebuff of religious attitudes that are borne out of what he describes as (...) misrepresentation of the gods or superstition. Plutarch’s essay is seen as illustrating a reason for a socio-religious situation in Africa, a continent that shares a similar religious background with the world of the writer. Specifically, with the example of the hard fight against street begging in some parts of Nigeria, the article shows how social reform programmes could fail when effects of traditional African beliefs and cultural practices remain potent. __. (shrink)

The Platonic Commentators.—After Cicero the Academy is no more than a few names to us for nearly five centuries. The nearest that we get to contact with it in this period is in the writings of Plutarch. He was himself a student there, and was well read in the books of Plato and the commentaries thereon.

The article discusses major biographical milestones and provides a general evolution of philosophical views of the Russian philosopher Simon L. Frank. At the initial stage of the creative way, Frank is an economist and critical Marxist. Appeal to philosophy in the 1900s characterized by the influence of neo-Kantianism, the immanent philosophy and philosophy of life. Around 1908-12 Frank’s transition to the position of metaphysics begins to take shape his own philosophical system, absolute realism. One of the main features of the (...) work of Frank is consistency. Throughout his creative career, the philosopher developed the deepened and detailed original philosophical intuition - the intuition of the supra-rational unity of being - which was already fixed in his early philosophical works. Absolute being is a concrete metalogical reality, revealed in the living knowledge Simultaneously, the potentiality and transfiniteness of absolute being acts as the basis of individuality and creativity of man, the source of his freedom. The philosophical method of Frank, rational comprehension of rationally incomprehensible, based on the principle of antinomic monodualism. Philosophy of religion unfolds as a phenomenological analysis of religious experience. In the social political field Frank justifies the position of liberal conservatism and Christian realism. (shrink)

Адресовано курсантам и слушателям образовательных учреждений, учебных центров, центров дополнительной подготовки, курсов повышения квалификации системы МВД Российской Федерации.

Outlines a method of solving mathematical problems for teachers and students based upon the four steps of understanding the problem, devising a plan, carrying out the plan, and checking the results.