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 (...) participants, in an... (shrink)

It is commonly presumed that the earliest recoverable writing of the New Zealand born Philosopher Arthur N. Prior is that published in the Australasian Journal of Philosophy and Psychology in 1937. Yet Prior was an extremely active writer as both an undergraduate and as a recent graduate, in a variety of publications. This paper recovers the unknown early Prior and discusses the importance of neo–orthodox Christian theology upon the life and thought of the early Arthur Prior. During the 1930s Prior (...) was primarily a theologian–philosopher and in these early writings there can be discerned important influences upon his thinking. This paper traces Prior’s writings from an early unpublished manuscript through his theological writings and the development of his neo–orthodox thinking to a point where preparatory work for his influential 1942 article ‘Can Religion be Discussed?’ occurs. It ends where Prior bibliographies begin, with a theologian–philosopher remaking himself as a philosopher theologian. Yet to understand the later Prior we need to understand his early life, thought and writing. This paper is an attempt to recover Prior’s early life and note his influences and talent in areas apart from tense logic. (shrink)

In this collection of Taubes's writings on Schmitt, the two intellectuals work through ideas of the apocalypse and other central concepts of political theology.

The ability to quickly and accurately recognise emotional states is adaptive for numerous social functions. Although body movements are a potentially crucial cue for inferring emotions, few studies have studied the perception of body movements made in naturalistic emotional states. The current research focuses on the use of body movement information in the perception of fear expressed by targets in a virtual heights paradigm. Across three studies, participants made judgments about the emotional states of others based on motion-capture body movement (...) recordings of those individuals actively engaged in walking a virtual plank at ground-level or 80 stories above a city street. Results indicated that participants were reliably able to differentiate between height and non-height conditions (Studies 1 & 2), were more likely to spontaneously describe target behaviour in the height condition as fearful (Study 2) and their fear estimates were highly calibrated with the fear ratings from the targets (Studies 1-3). Findings show that VR height scenarios can induce fearful behaviour and that people can perceive fear in minimal representations of body movement. (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)

In Sonic Virtuality: Sound as Emergent Perception, authors Mark Grimshaw and Tom Garner introduce a novel theory that positions sound within a framework of virtuality. Arguing against the acoustic or standard definition of sound as a sound wave, the book builds a case for a sonic aggregate as the virtual cloud of potentials created by perceived sound. The authors build on their recent work investigating the nature and perception of sound as used in computer games and virtual environments, and put (...) forward a unique argument that sound is a fundamentally virtual phenomenon.Grimshaw and Garner propose a new, fuller and more complete, definition of sound based on a perceptual view of sound that accounts more fully for cognition, emotion, and the wider environment. The missing facet is the virtuality: the idea that all sound arises from a sonic aggregate made up of actual and virtual sonic phenomena. The latter is a potential that depends upon human cognition and emotion for its realization as sound. This thesis is explored through a number of philosophical, cognitive, and psychological concepts including: issues of space, self, sonosemantics, the uncanny, hyper-realism, affect, Gettier problems, belief, alief, imagination, and sound perception in the absence of sound sensation.Provocative and original, Grimshaw and Garner's ideas have broader implications for our relationship to technology, our increasingly digital lives, and the nature of our being within our supposed realities. Students and academics from philosophy to acoustics and across the broad spectrum of digital humanities will find this accessible book full of challenging concepts and provocative ideas. (shrink)

In the face of a perceived lack of widespread understanding of the theoretical issues underlying the development, dissemination and implementation of clinical guidelines, the Royal College of General Practitioners Guidelines Group developed a 2-day course aimed at teaching the theory in these areas. The course was targeted at potential opinion formers and ran on six occasions. Postal questionnaire assessment of the course revealed high levels of satisfaction with all aspects of the course and high levels of reported use of the (...) knowledge gained. Further developments of the course are discussed. (shrink)

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 (...) well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs. (shrink)

This article illustrates how language variation and the limits of variation are given a shared and principled explanation in Optimality Theory. It shows that languages can be ‘uniform’, choosing the same grammatical structures in three different sentence types. They can also be ‘non-uniform’, but the combinations of grammatical structures that they can exhibit are extremely restricted. The theory characterizes possible and impossible grammatical systems without special stipulations or additional theoretical machinery.

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 (...) relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed? (shrink)

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 (...) role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

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 (...) role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

Comprising essays focusing on the representation of women's bodies in historical and contemporary cultures, this book compares the two different approaches to the body adopted by a soft-porn magazine, For Women, and Cosmopolitan.

Eye-tracking techniques were used to measure men’s attention to back-posed and front-posed images of women varying in waist-to-hip ratio (WHR). Irrespective of body pose, men rated images with a 0.7 WHR as most attractive. For back-posed images, initial visual fixations (occurring within 200 milliseconds of commencement of the eye-tracking session) most frequently involved the midriff. Numbers of fixations and dwell times throughout each of the five-second viewing sessions were greatest for the midriff and buttocks. By contrast, visual attention to front-posed (...) images (first fixations, numbers of fixations, and dwell times) mainly involved the breasts, with attention shifting more to the midriff of images with a higher WHR. This report is the first to compare men’s eye-tracking responses to back-posed and front-posed images of the female body. Results show the importance of the female midriff and of WHR upon men’s attractiveness judgments, especially when viewing back-posed images. (shrink)

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 (...) lack of consensus on answers to these questions highlights the need for ethical guidance. Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research. (shrink)

In this paper I want to discuss an issue which has generated a great deal of feminist discussion and some profound disagreement. The issue arises as follows. One of the most important targets of feminist action and critique has been male sexual violence and control of women, as expressed in rape and other forms of violent or aggressive sexual acts, and as represented in much pornography. Pornography itself has been the subject of major and sometimes bitter disagreements among feminists, especially (...) around the issue of censorship. But it is not that with which I am concerned here. The issue which I want to discuss involves the question of sexual desire and fantasy, and their apparent potential incompatibility with political and ethical principles. This is by no means, of course, an issue of exclusively feminist concern; but I shall focus on some recent feminist argument, since it is that with which I am most familiar. (shrink)

Many recent studies have appealed to the idea that linguistic systems are subject to economy of structure or representation, e.g. Chomsky 1995, Rizzi 1997, Bresnan 2001. The guiding idea of economy of structure is that small structures are preferred over large ones, other things being equal. Other things being equal, projections with fewer elements are preferred over projections with more elements, and structures containing fewer projections are preferred over structures with more projections.