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)

The self- vs. external-regulation behavior theory, SR-ER Theory model has postulated the Self-Regulation /Non or De-Regulation/Dys-regulation continuum in the person and in their context. The model also generates a behavioral heuristic that allows us to predict and explain the variability of other dependent behavioral variables in a range of scenarios. Consequently, the objective of this study was to validate the different scales prepared on the basis of the theory presented. A total of 469 students voluntarily completed at different times the (...) five questionnaires presented, to give a total of 1,385 completed questionnaires. Using an ex post facto design, descriptive, correlational, confirmatory factorial analysis, reliability, and concurrent validity analyses were carried out. The scales were analyzed individually and as a whole. The results showed the acceptable structure of scale and consistent levels of reliability. The five levels generated by the SR-NR-DR combinatory heuristic that arises from the theoretical model determined significant differences in the levels of the variables analyzed for each psychological context. We discuss the theoretical implications and the implications for the assessment and improvement of the behaviors analyzed in function of the personal and contextual regulation levels evaluated. (shrink)

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become “immortalized” in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched (...) to each other. Reidentification, the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants. The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants’ consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform—the Personal Genome Project—to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research. (shrink)

The compact and, with \ M\, very massive object located at the center of the Milky Way is currently the very best candidate for a supermassive black hole in our immediate vicinity. The strongest evidence for this is provided by measurements of stellar orbits, variable X-ray emission, and strongly variable polarized near-infrared emission from the location of the radio source Sagittarius A* in the middle of the central stellar cluster. Simultaneous near-infrared and X-ray observations of SgrA* have revealed insights into (...) the emission mechanisms responsible for the powerful near-infrared and X-ray flares from within a few tens to one hundred Schwarzschild radii of such a putative SMBH. If SgrA* is indeed a SMBH it will, in projection onto the sky, have the largest event horizon and will certainly be the first and most important target for very long baseline interferometry observations currently being prepared by the event horizon telescope. These observations in combination with the infrared interferometry experiment GRAVITY at the very large telescope interferometer and other experiments across the electromagnetic spectrum might yield proof for the presence of a black hole at the center of the Milky Way. The large body of evidence continues to discriminate the identification of SgrA* as a SMBH from alternative possibilities. It is, however, unclear when the ever mounting evidence for SgrA* being associated with a SMBH will suffice as a convincing proof. Additional compelling evidence may come from future gravitational wave observatories. This manuscript reviews the observational facts, theoretical grounds and conceptual aspects for the case of SgrA* being a black hole. We treat theory and observations in the framework of the philosophical discussions about “realism and underdetermination”, as this line of arguments allows us to describe the situation in observational astrophysics with respect to supermassive black holes. Questions concerning the existence of supermassive black holes and in particular SgrA* are discussed using causation as an indispensable element. We show that the results of our investigation are convincingly mapped out by this combination of concepts. (shrink)

By drawing on a selection of interviews from the website Engaged Philosophy, this paper highlights the work of philosopher-activists within their classrooms and communities. These philosophers have stepped out of the ivory towers and work directly with media, community and political groups, people in prison; or they encourage their students to engage in activist projects. The variety of approaches presented here shows the many ways philosophically inspired activism can give voice to those who are marginalized, shine a light on injustices, (...) expose the root of social problems, and empower others to seek solutions. This work shows the relevance of philosophy to practical problems and the powerful effects it can have in the world. (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)

Blumenthal-Barby et al. (2022) are right. Philosophers should pay greater attention to bioethics and bioethicists should pay greater attention to insights from philosophy. This commentary extends t...

São escassas as investigações sobre problemas internalizantes em adultos brasileiros. Estudos epidemiológicos apontam que ansiedade e depressão são mais comuns em mulheres. Este estudo apresenta uma investigação com 240 adultos de diferentes municípios da Região Metropolitana da Baixada Santista, com uso do Adult Self Report. Dados foram analisados por estatística descritiva e inferencial, considerando a variável sexo. Não foram encontradas diferenças significativas entre homens e mulheres da amostra em termos de problemas internalizantes, ansiedade/depressão, retraimento e queixas somáticas. Resultados são discutidos (...) à luz de dados epidemiológicos sobre transtornos mentais em outros recortes populacionais brasileiros. Ficam sugeridos novos estudos com ampliação de amostra. (shrink)

Recent studies have shown that making accurate passage of time judgments (POTJs) for long-time intervals is an important cognitive ability. Different temporal domains, such as circadian typology (biological time) and time perspective (psychological time), could have an effect on subjective POTJs, but few studies have investigated the reciprocal influences among these temporal domains. The present study is the first systematic attempt to fill this gap. A sample of 222 participants (53.20% females; 19–60 years) filled in the Zimbardo Time Perspective Inventory (...) for the measurement of time perspective, the reduced version of the Morningness-Eveningness Questionnaire (rMEQ) for chronotypes, and an ad-hoc questionnaire assessing sleep habits during weekdays and the weekend (for social jetlag). The POTJ was measured using a modified version of a pictorial timeline presented at five different moments. Also, participants judged how different temporal expressions were related to the past, present, and future along a 7-point Likert scale. After confirming the association between eveningness and present-hedonism orientation and morningness and future-orientation, we found that evening-types produced higher scores for future expressions. The subjective POTJ expressed in minutes was predicted by Deviation from Balanced Time (DBTP), present-fatalism orientation, and social jetlag. Finally, the rMEQ score, past-positive orientation, and DBTP predicted the difference between subjective and objective POT. The results are discussed offering an explanation in terms of the interconnections between circadian typology, individual time perspective, and the sense of the POT, suggesting the multicomponent nature of the concept of time. (shrink)

Background: Mentalizing, the mental capacity to understand oneself and others in terms of mental states, has been found to be reduced in several mental disorders. Some studies have suggested that eating disorders may also be associated with impairments in mentalizing. The aim of this work is to investigate the possible presence of mentalizing subtypes in a sample of patients with EDs.Method: A sample of patients with eating disorders completed a battery of measures assessing mentalization and related variables, including the Reflective (...) Functioning Questionnaire, the Difficulties in Emotion Regulation Strategies, the Interpersonal Reactivity Index. Clinicians rated patients in relation to imbalances in different dimensions of mentalization to prementalizing modes and attachment style by using the Mentalization Imbalances Scale, the Modes of Mentalization Scale, and the Adult Attachment Questionnaire. A latent profile analysis was conducted to test the possible presence of different subgroups. MANOVA was used to test the possible differences between the four mentalizing profiles in relation to emotion dysregulation, empathy, and adequate and impairments in mentalizing.Results: The latent profile analysis suggested the presence of four different profiles in relation to impairments in the dimensions of mentalization: affective/self/automatic imbalances, external imbalance, cognitive/self/automatic imbalances, and cognitive/other/automatic imbalances. Patients belonging to profile 1 are characterized by the prevalence of affective mentalization that overwhelms the capacity to reflect on mental states with an imbalance on the self-dimension; profile 2 patients are excessively focused on the external cues of mentalization; profile 3 patients are characterized by an over-involvement on the cognitive and self-facets of mentalization, with an impairment in adopting the other mind perspective; and profile 4 patients have similar impairments compared to profile 3 patients but with an excessive focus on others and deficits in self-reflection. These profiles were heterogeneous in terms of EDs represented in each group and presented significant differences on various variables such as attachment style, emotion dysregulation, empathy, interpersonal reactivity, and reflective function. This study represents, so far, the first work that confirms the presence of different mentalizing patterns in ED patients.Conclusions: ED patients can be classified in relation to impairments in different dimensions of mentalization above and beyond ED diagnosis. (shrink)

Josefa Amar y Borbón, une intellectuelle espagnole du XVIIIe siècle, défendit dans ses ouvrages et dans sa vie la raison des femmes, à partir de sa propre tradition culturelle mais simultanément avec d’autres intellectuelles européennes de son temps. Elle se forgea un prestige intellectuel et intervint publiquement dans le débat sur l’admission des femmes dans les sociétés réformistes, contre l’opinion négative d’une partie des hommes des élites éclairées espagnoles. La lecture de ses textes et leur comparaison avec la pensée de (...) sa contemporaine Mme d’Épinay montre que, dans des contextes sociaux et culturels différents, ces deux femmes avait des idées concordantes sur la raison, l’éducation et la condition social des femmes, loin des opinions plus répandues, celles des auteurs comme Thomas, Rousseau et d’autres contemporains espagnols. Elles avaient aussi des stratégies vitales communes, qui visaient à occuper et à revendiquer pour les femmes des possibilités et des espaces dans l’activité culturelle et la sociabilité des Lumières. (shrink)

Caracterización de un grupo de comités de ética en investigación en Colombia Caracterização de um grupo de comitês de ética em pesquisa na Colômbia In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute, the regulator in (...) the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation. Para citar este artículo / To reference this article / Para citar este artigo Suárez-Obando F, Reynales H, Urina M, Camacho J, Viteri M. Caracterización de un grupo de comités de ética en investigación en Colombia. pers. bioét. 2018; 22: 303-318. DOI: 10.5294/pebi.2018.22.2.8. (shrink)

Cada día, la guerra, la persecución ideológica y la violencia en las calles obligan a millones de familias a abandonar sus hogares.La literatura infantil y juvenil y, en concreto, los álbumes ilustrados, se convierten en un instrumento didáctico fundamental para abordar temáticas complejas como la guerra y los desplazamientos forzosos en las aulas.Teniendo en cuenta esto, ¿existen álbumes ilustrados dedicados a estas temáticas?¿Cómo podemos aprovecharlos en el aula? El presente trabajo pretende dar respuesta a estas preguntas a partir de una (...) propuesta práctica concreta y de una aproximación teórica a los conceptos que la conciernen. (shrink)

Through cultural transmission, repeated learning by new individuals transforms cultural information, which tends to become increasingly compressible . Existing diffusion chain studies include in their design two processes that could be responsible for this tendency: learning and reproducing . This paper manipulates the presence of learning in a simple iterated drawing design experiment. We find that learning seems to be the causal factor behind the increase in compressibility observed in the transmitted information, while reproducing is a source of random heritable (...) innovations. Only a theory invoking these two aspects of cultural learning will be able to explain human culture's fundamental balance between stability and innovation. (shrink)

National and international research cultures for the innovation of new medicines involve various value claims about the ethics of the placebo entity as differentiating comparator. Yet, in turn, the instantiation of the placebo comparator as cultural artefact for the creation and identification of the ‘control group’ depends also upon prior social understandings of ‘comparability’. Reading back the ethics controversies surrounding the Risperidone psychiatry trials in India, the paper illustrates why drug efficacies need to be studied not only through comparative techniques (...) such as randomised controlled trials, but also through analytical modes of inquiry that can begin to place the problem of efficacy within particular social and cultural contexts, as well as across disciplines. It is suggested that future bioethics debates could benefit from a revised conception of the interdisciplinary placebo — one that is rooted in ‘placebo politics’ and that listens responsively to the voices of the global South. (shrink)

Blockchain is an open digital ledger technology that has the capability of significantly altering the way that people operations operate in organizations. This research takes a first step in proposing several ways in which the blockchain technology can be used to improve current organizational practices, while also considering the ethical implications. Specifically, the paper examines the role that blockchain technology plays in three primary areas of people operations: entry to the organization, intraorganizational processes, and exit. In each section, the paper (...) reviews the ethical implications from the lenses of virtue ethics, utilitarianism, deontology and contractarianism. The paper concludes that in whole the implementation of blockchain technology in people operations processes can create a more ethical work environment. However, careful implementation is necessary and requires extensive examination of ethical implications in advance. (shrink)

Ethical leadership matters in the context of organizational change due to the need for followers to trust the integrity of their leaders. Yet, there have been no studies investigating ethical leadership and organizational change. To fill this gap, we introduce a model of the moderating role of involvement in change. Organizational change and involvement in change are proposed as context-level moderators in the relationships of ethical leadership and work-related attitudes and performance. We employ a sample of 199 supervisor–subordinate pairs from (...) a wide variety of organizations. Results support a three-way interaction (ethical leadership, organizational change, and involvement in change) for performance and OCBs. Our results have important implications for organizational change since ethical leadership appears to complement follower involvement when change is happening. (shrink)

The employment of mythological language and imagery by an Epicurean poet - an adherent of a system not only materialist, but overtly hostile to myth and poetry - is highly paradoxical. This apparent contradiction has often been ascribed to a conflict in the poet between reason and intellect, or to a desire to enliven his philosophical material with mythological digressions. This book attempts to provide a more positive assessment of Lucretius' aims and methodology by considering the poet's attitude to myth, (...) and the role which it plays in the De Rerum Natura, against the background of earlier and contemporary views. The author suggests that Lucretius was not only aware of the tension between his two roles as philosopher and poet, but attempted to resolve it by developing his own, Epicurean poetic, together with a bold and innovative theory of the origins and meaning of myth. (shrink)

Volume 19, Issue 5, May 2019, Page 62-63.

Significant scientific and technological advances in intensive care have been made. However, patients in the intensive care unit may experience discomfort, loss of control, and surreal experiences. This has generated relevant debates about how to humanize the intensive care units and whether humanization is necessary at all. This paper aimed to explore how humanizing intensive care is described in the literature. A scoping review was performed. Studies published between 01.01.1999 and 02.03.2020 were identified in the CINAHL, Embase, PubMed, and Scopus (...) databases. After removing 185 duplicates, 363 papers were screened by title and abstract. Full-text screening of 116 papers led to the inclusion of 68 papers in the review based on the inclusion criteria; these papers mentioned humanizing or dehumanizing intensive care in the title or abstract. Humanizing care was defined as holistic care, as a general attitude of professionals toward patients and relatives and an organizational ideal encompassing all subjects of the healthcare system. Technology was considered an integral component of intensive care that must be balanced with caring for the patient as a whole and autonomous person. This holistic view of patients and relatives could ameliorate the negative effects of technology. There were geographical differences and the large number of studies from Spain and Brazil reflect the growing interest in humanizing intensive care in these particular countries. In conclusion, a more holistic approach with a greater emphasis on the individual patient, relatives, and social context is the foundation for humanizing intensive care, as reflected in the attitudes of nurses and other healthcare professionals. Demands for mastering technology may dominate nurses’ attention toward patients and relatives; therefore, humanized intensive care requires a holistic attitude from health professionals and organizations toward patients and relatives. Healthcare organizations, society, and regulatory frameworks demanding humanized intensive care may enforce humanized intensive care. (shrink)

The results in this paper are in a context of abstract elementary classes identified by Shelah and Villaveces in which the amalgamation property is not assumed. The long-term goal is to solve Shelah’s Categoricity Conjecture in this context. Here we tackle a problem of Shelah and Villaveces by proving that in their context, the uniqueness of limit models follows from categoricity under the assumption that the subclass of amalgamation bases is closed under unions of bounded, -increasing chains.

Cet article vise à situer les notions de sujet, de corps et de vie chez Foucault à partir du passage d’un cadre conceptuel basé sur les notions de corps-pouvoir à un centré sur celles de vie-gouvernement. Mon hypothèse est que ce mouvement caractérise le développement de ses recherches entre les années 1970 et les années 1980. Le problème central est la difficulté de penser le statut ontologique des rapports de pouvoir (au sens physique) sans attribuer au corps une sorte de (...) qualité ontologique du même type (comme dans tous les formes de vitalisme), ce qui conduit Foucault à privilégier la thèmatique de la vie à celle du corps dans le développement de sa « question du sujet ». (shrink)

As a neonatal neurologist, I serve families facing tragic decisions in which they must balance trade-offs between death and life with profound disability. I often find myself in complex discussions about future outcome, in which families sort through in real-time what information they value most in making such a choice. Will he laugh? Will he be in pain? Will he know how much he’s loved? In this month’s feature article, Brick et al share the results of an online survey aimed (...) at assessing public views on when a life is not worth living, in an effort to inform ongoing legal and clinical debates about withdrawal of life-sustaining treatment for children. These findings raise important questions about how we define and measure outcomes that matter to parents as they make these tragic decisions. It is challenging to interpret these findings in the absence of context of how decision-making for infants occurs in real-time. The nature of this study and its objective required that cases be substantially simplified. As the authors acknowledge, the prognoses and function of the children involved in these cases were often deeply contested. Prognostic uncertainty is common for children with significant …. (shrink)

Aristotle posits that time, as defined by the “number of motion in respect of before and after” (_Physics_ IV 11.219b1-2), is an inherent property of motion itself rather than a prerequisite. This implies the possibility of identifying time-independent properties of natural motions. One such critical feature, crucial to understanding the basic meaning of time, is the presence of an inherent order of before and after within motion, regardless of time. The concept of a non-temporal before and after within motion is (...) now accepted or seriously considered in scholarly discussions. However, it remains one of the most confusing and difficult issues in the interpretation of Aristotle’s conception of time. How can we conceive of motion apart from time? Moreover, how does Aristotle seemingly take this aspect for granted? In order to address these issues, I propose to combine philosophical inquiry with grammatical and mathematical reflections. I will examine the analysis of motion alongside the verbs used to describe it, with a keen focus on aspect. Hence I will draw connections between the relationship of motion and time and that of physical and mathematical objects. (shrink)

The promise of genomic medicine lies in the opportunity to improve health outcomes via a personalized approach to management, grounded in genetic and genomic variation unique to an individual. However, disparities and inequities mar this remarkable landscape of genomic innovation. Prior efforts to understand these inequities have focused on populations for which genetic testing is relatively protocolized or where test utility varies greatly by ancestry groups, where equitable outcomes are more clearly defined. We therefore consider the current landscape of rare (...) disease genomics, in which diagnostic approaches vary widely and utility remains to be fully understood, and suggest a path forward: how ecosocial theory may be used to guide novel equity‐focused initiatives that incorporate illness narratives to improve population health. We present examples of narrative medicine in rare disease and reimagine the role this discipline may play in genomic sequencing studies, toward incorporation of the unique illness narrative into clinical genetics and genomics practice. Approaches that broaden the definitions of disease and of outcomes of interest will force the field to grapple with its racist history and begin to advance health equity and promote justice so that genomic medicine may truly deliver on its promise. (shrink)

In this paper, we are going to address job satisfaction and perceived self-efficacy within the context of residential child-care. A joint report from the European Foundation for the Improvement on Living and Working Conditions and the European Agency for Safety and Health at Work revealed that managers in the field of health and education were the most concerned about the psychosocial risk of their employees, although concern is not automatically translated into tools to face the risk and to manage it. (...) So, measuring and improving employees’ job satisfaction and self-efficacy can be an important means for organizations to prevent the outcomes of psychosocial risk, and supporting high quality performance of workers. But profound changes are affecting the nature of work at large, and specifically social educator’s in the field of residential care with minors. Globalization, radical technological and communication developments, as well as the pressure to frame care as a commodity, are quickly changing procedures and praxis at work, and even the meaning of job itself. All these changes are highly demanding for this category of professionals, as much as the fact that the organizational setting is vanishing as a resource to sustain their professional attitudes and behaviours. Under these circumstances, job satisfaction and self-efficacy can be hard to experience, and isolating their precursors is essential to develop healthy and effective work environments. This paper means to highlight the process of supporting self-efficacy and job satisfaction in the educational work in residential youth care that is still underrepresented in research. It presents data emerging from two studies, study 1 involving 268 educators and study 2 involving 472 educators belonging to different Italian residential child-care services. Study 1 consists of a quantitative study including the following measures: attachment style, job satisfaction, work-related self-efficacy, and length of service. Study 2 consist of a qualitative exploration deepening the sources of educators’ work-satisfaction. Quantitative data support the identification of attachment style and length of service as antecedents of work-related self-efficacy. Qualitative data show the importance of relational issues in shaping the educators’ satisfaction at work. (shrink)

Understanding what it means toconsent is of considerable importance sincesignificant moral issues depend on how this actis defined. For instance, determining whetherconsent has occurred is the deciding factor insexual assault cases; its proper occurrence isa necessary condition for federally fundedhuman subject research. Even though mosttheorists recognize the legal and moralimportance of consent, there is still littleagreement concerning how consent should bedefined, or whether different domains involvingconsent demand context-specific definitions.Understanding what it means to consent isfurther complicated by the fact that currentlegal (...) conceptions are not necessarily groundedin argument; they typically depend on appealsto authority and precedent. The purpose ofthis paper is to use speech act theory toprovide a theoretically grounded conception ofconsent; such a conception can aid in the justresolution of legal and moral disputes thathinge on whether an act of consent occurred. (shrink)