BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.MethodsThe template was (...) based on a literature review including systematic reviews and guidelines searched on PubMed, Embase, Cochrane Library, NICE, SIGN, GIN, and Clearinghouse databases, and on comparison of templates gathered through an extensive search on the websites of research institutes, national and international agencies, and international initiatives. We discussed the draft versions step-by-step and then we referred to it as the “matrix” to underline its modular character and indicate that it allows adaptation to the context in which it will be used. The matrix was revised by representatives of two international patient groups.ResultsThe matrix covers the process of ensuring that the appropriate information, context and setting are provided so that the participant can give truly informed consent. It addresses the key topics and proposes wording on how to clarify the meaning of placebo and of non-inferiority studies, the importance of individual participants’ data sharing, and the impossibility of knowing in advance how the data might be used in future studies. Finally, it presents general suggestions on wording, format, and length of the information sheet.ConclusionsThe matrix underlines the importance of improving the process of communication, its proper conditions (space, time, setting), and addresses the participants’ lack of knowledge on how clinical research is conducted. It can be easily applied to a specific setting and could be a useful tool to identify the appropriate informed consent format for any study. The matrix is mainly intended to support multicentre interventional randomized clinical studies, but several suggestions also apply to non-interventional research. (shrink)

In developed countries, companies are now substantially reliant on the skills and abilities of their leaders to tackle a variety of complex issues. There is a growing consensus that leadership development training and assessment methods should adopt more holistic methodologies, including those associated with the emotional and neuroendocrine aspects of learning. Recent research into the assessment of leadership competencies has proposed the use of objective methods and measurements based on neuroscience. One of the challenges to be faced in the development (...) of a performance-based methodology to measure leadership skills is how to generate real-life situations with triggers that allow us to study management competencies under controlled laboratory conditions. A way to address this question is to take advantage of virtual environments to recreate real-life situations that might arise in performance-based assessments. We propose virtual reality (VR) as a very promising tool to observe various leadership related behavioral patterns during dynamic, complex and realistic situations. By seamlessly embedding assessment methods into virtual learning environments, VR can provide objective assessment methods with high ecological validity. VR also holds unlimited opportunities for leadership training providing subjects with intelligent tutoring systems that adapts situations in real time according to the observed behaviors. (shrink)

Digital energy platforms play a central role in the transition toward a more sustainable energy system. This research explores the effect of digital energy platforms on public values. We developed and tested a novel public value framework, combining values already embedded in energy and digitalization regulations and emerging values that have become more relevant in recent debates. We analyzed value changes and potential value tensions. We found that sustainability is prioritized, security is broadened to include cybersecurity, and values relevant for (...) digital technologies, such as control over technology, have also become relevant for the energy system. This has resulted in three value tensions: preserving a well-functioning energy system, self-determination, and ensuring a level playing field and public control. A sustainable energy system requires governments to address these value changes, value tensions, and connected societal and political challenges related to the implementation of digital energy platforms. (shrink)

A equipe da Enfermagem é privilegiada, pois, é o cuidador que permanece vinte e quatro horas na assistência direta do paciente, podendo ter uma visão ampliada da pessoa no processo do adoecimento, tendo a oportunidade de incorporar e desenvolver os princípios dos Cuidados Paliativos (CP). Na perspectiva holística da saúde a religião/religiosidade/espiritualidade é uma das possibilidades de cuidado e manejo, porém ainda muito negligenciada pelos profissionais da saúde, seja por desconhecimento ou preconceitos e tabus, mas que se torna essencial no (...) cuidado de pacientes em CP. Por meio deste relato de experiência, objetiva-se ressaltar a importância da religião/religiosidade/espiritualidade, no cuidado e manejo de pacientes em CP, a partir da experiência de uma profissional da enfermagem, sua prática em cuidados e docência, supervisionando alunos com pacientes em contexto dos CP. Anos acompanhando alunos na prática, demonstraram que os profissionais da enfermagem têm dificuldade de identificar o Sofrimento Espiritual (SE) dos pacientes, e quando identificavam, não sabiam o que fazer com esta demanda, delegando a outros profissionais da equipe, que também tinham dificuldades, causando um (des)cuidado na Dimensão Espiritual (DE) do paciente em CP, trazendo-o mais sofrimento e desconforto com sua finitude. Como resultado dessas reflexões, está sendo desenvolvida uma pesquisa de pós-doutorado, destinada a identificar a DE, construção de roteiro de educação permanente. Em síntese, esses profissionais tendo a capacitação para identificar o SE, explorar e cuidar da DE, poderão promover a proteção da saúde mental, tanto do paciente em CP quanto sua, e tornarem-se profissionais mais sensíveis na finitude. (shrink)

We explore the relationship between chief executive officer (CEO) personality traits and corporate social responsibility (CSR) reporting. Upper echelons theory indicates that the values, experiences, and personalities of top organizational managers influence their organization's strategic decisions and effectiveness. We utilize IBM Watson Personality Insights software to infer CEOs’ personality traits based on their responses to questions raised by analysts during year‐end conference calls; we obtain CEOs’ Big Five personality traits—openness, conscientiousness, extraversion, agreeableness, and neuroticism—from which we compute a measure of (...) their risk tolerance. Using a longitudinal dataset of Standard and Poor's 500 firms for 2008–2015, we document that high CEO risk tolerance is related to lower CSR report readability and smaller CSR disclosure volume. This finding indicates that executives who are comfortable with greater risk are more willing to supply stakeholders with reports that are shorter and require greater effort to understand. Exploration of the association between CEO Big Five personality traits and CSR report readability and disclosure volume allows key stakeholders to better comprehend CSR disclosures and connotations thereof. Overall, our results contribute to the debate on how CEO personality traits affect organizations’ CSR disclosure reporting strategies, and support upper echelons theory in the CSR setting. (shrink)

Gervain et al. discuss both behavioral and neurophysiological AGL studies that investigate rule and structure learning processes in infants. The paper provides an overview of all the major AGL paradigms used to date to investigate infant learning abilities at the level of morpho‐phonology and syntax from a very early age onwards. Gervain et al. also discuss the implications of the results for a general theory of natural language acquisition.

Despite the growing interest in societal impact in the business and society literature, there remains a notable gap in research on the impact of health interventions on physical and mental health and social welfare. To address this gap, we shift the unit of analysis to the intervention, akin to the level of analysis used in health research. Drawing on a curated subset of health interventions in the workplace from the public health literature, we argue that management scholars can adopt the (...) methods used by public health scholars to design and assess health interventions. By tapping into the rich insights gained from these studies, management scholars can propose evidence-based interventions and policies that can enhance health outcomes, improve productivity, and cultivate a healthier workplace atmosphere. Collaborating with public health researchers, business and society scholars can help create a new field of research on corporate health policy. (shrink)

Current research has focused on gender as a conditioning factor in students’ study choices, highlighting the existence of gender stereotypes associated with these choice. The general objective of this article is to analyse if there are differences based on sex in the choice of musical instruments in music conservatories. The methodology used is quantitative. We have analysed the data on enrolment in the different instrumental specialities of two public music conservatories in Seville (Spain) at the three levels of music education: (...) Basic, Professional and Higher Music Education. This article contrasts if there are instrumental specialities that are mostly chosen by one or the other sex, and to check if this sexual segregation has been produced by chance or can be explained by other causes. This investigation was carried out for a total of 4120 students from two different conservatories. The main conclusions of the study were the existence of feminized and masculinized instrumental families, and the relationship between the variables “students’ sex” and “instrumental families and musical specialities” was significant with a medium effect size. This research confirms that men and women choose the instruments that have traditionally been associated with their male or female roles respectively. (shrink)

Gene‐editing research is a complex science and foreign in most communities including Botswana. Adopting a qualitative deliberative framework with 109 participants from 7 selected ethnic communities in Botswana, we explored the perceptions of local communities on cultural values, norms, and beliefs that may motivate or deter likely participation in the use of gene‐editing related research. What emerged as the ethnic community's motivators for research participation include the potential for gene‐editing technologies to promote access to individualized medications, and the possibility of (...) protecting family members from genetic related diseases. Deterrents for research participation include cultural values such as implications of lineage for chieftainship, trust, fear or anxiety, uncertainty, and sensitivity on the use of gene‐editing. Findings of our study have implications for continuous engagement with local communities to explore potential ways of addressing cultural sensitivities that can further deter their participation in future gene‐editing related research. (shrink)

To our knowledge, this is one of the first studies to test different theoretical models of working memory in childhood based on a computerized assessment. We tested this across several countries: Argentina, Brazil, Canada, Italy, and UK. The present study addressed the wider macro-cultural context and how this impacts working memory. We used two economic indices to characterize the participating countries and ranked the countries based on the Global Index of Cognitive Skills and Educational Attainment. Children between 5 and 10 (...) years completed the same set of short-term and working memory tests. There were two main findings. First, there was a similar pattern in verbal working memory across countries, which suggests that this skill may be relatively consistent across different cultural groups. In contrast, the pattern for visuo-spatial working memory was different across countries, which may explained by cultural differences and educational rankings of the countries. The second main finding was that both a domain-general model and a domain-specific model provided a reasonably good fit with the data, there was the high relationship between the verbal and visuo-spatial working memory constructs across the countries in the latter model. Thus, it may be a more parsimonious choice to rely on a three-factor model. The data also suggest culture-similar patterns in a computerized assessment of working memory. (shrink)

The heart has a high‐metabolic rate, and its “around‐the‐clock” vital role to sustain life sets it apart in a regenerative setting from other organs and appendages. The landscape of vertebrate species known to perform intrinsic heart regeneration is strongly biased toward ectotherms—for example, fish, salamanders, and embryonic/neonatal ectothermic mammals. It is hypothesized that intrinsic heart regeneration is exclusively limited to the low‐metabolic hearts of ectotherms. The biomedical field of regenerative medicine seeks to devise biologically inspired regenerative therapies to diseased human (...) hearts. Falsification of the ectothermy dependency for heart regeneration hypothesis may be a crucial prerequisite to meaningfully seek inspiration in established ectothermic regenerative animal models. Otherwise, engineering approaches to construct artificial heart components may constitute a more viable path toward regenerative therapies. A more strict definition of regenerative phenomena is generated and several testable sub‐hypotheses and experimental avenues are put forward to elucidate the link between heart regeneration and metabolism. Also see the video abstract here https://youtu.be/fZcanaOT5z8. (shrink)

Before COVID-19, dementia singing groups and choirs flourished, providing activity, cognitive stimulation, and social support for thousands of people with dementia in the UK. Interactive music provides one of the most effective psychosocial interventions for people with dementia; it can allay agitation and promote wellbeing. Since COVID-19 has halted the delivery of in-person musical activities, it is important for the welfare of people with dementia and their carers to investigate what alternatives to live music making exist, how these alternatives are (...) delivered and how their accessibility can be expanded. This community case study examines recent practice in online music-making in response to COVID-19 restrictions for people with dementia and their supporters, focusing on a UK context. It documents current opportunities for digital music making, and assesses the barriers and facilitators to their delivery and accessibility. Online searches of video streaming sites and social media documented what music activities were available. Expert practitioners and providers collaborated on this study and supplied input about the sessions they had been delivering, the technological challenges and solutions they had found, and the responses of the participants. Recommendations for best practice were developed and refined in consultation with these collaborators. Over 50 examples of online music activities were identified. In addition to the challenges of digital inclusion and accessibility for some older people, delivering live music online has unique challenges due to audio latency and sound quality. It is necessary to adapt the session to the technology's limitations rather than expect to overcome these challenges. The recommendations highlight the importance of accessibility, digital safety and wellbeing of participants. They also suggest ways to optimize the quality of their musical experience. The pandemic has prompted innovative approaches to deliver activities and interventions in a digital format, and people with dementia and their carers have adapted rapidly. While online music is meeting a clear current need for social connection and cognitive stimulation, it also offers some advantages which remain relevant after COVID-19 restrictions are relaxed. The recommendations of this study are intended to be useful to musicians, dementia care practitioners, and researchers during the pandemic and beyond. (shrink)

We explore the relationship between chief executive officer (CEO) personality traits and corporate social responsibility (CSR) reporting. Upper echelons theory indicates that the values, experiences, and personalities of top organizational managers influence their organization's strategic decisions and effectiveness. We utilize IBM Watson Personality Insights software to infer CEOs’ personality traits based on their responses to questions raised by analysts during year‐end conference calls; we obtain CEOs’ Big Five personality traits—openness, conscientiousness, extraversion, agreeableness, and neuroticism—from which we compute a measure of (...) their risk tolerance. Using a longitudinal dataset of Standard and Poor's 500 firms for 2008–2015, we document that high CEO risk tolerance is related to lower CSR report readability and smaller CSR disclosure volume. This finding indicates that executives who are comfortable with greater risk are more willing to supply stakeholders with reports that are shorter and require greater effort to understand. Exploration of the association between CEO Big Five personality traits and CSR report readability and disclosure volume allows key stakeholders to better comprehend CSR disclosures and connotations thereof. Overall, our results contribute to the debate on how CEO personality traits affect organizations’ CSR disclosure reporting strategies, and support upper echelons theory in the CSR setting. (shrink)

Written by two of the leading figures in the field, this is a lucid and systematic introduction to semantics as applied to transformational grammars of the ...

This collaborative companion piece, written as a postscript to the three preceding essays, highlights four themes in comparative religious ethics that emerge through our focus on sex and gender: language, embodiment, justice, and critique.

In this article, we examine how the U.N. Convention on the Rights of the Child can be useful in pediatric bioethics. Adopted in 1989, the CRC reflects norms that have been deliberated upon for a long period of time and endorsed by most nations. The United States is now the only country that has not ratified the CRC.1 International human rights law shares many key moral concepts with clinical pediatric bioethics, and the CRC provides a considered language common to many (...) jurisdictions that can assist bioethicists in their daily practice and help health-care organizations in their policy development and international interactions. There may, however, be practical challenges with using the CRC in the practice of.. (shrink)

Portion sizes of meals have been becoming progressively larger which contributes to the onset of obesity. So far, little research has been done on the influence of body weight on portion size preferences. Therefore, we assessed whether Body Mass Index, as well as other selected factors, contribute to the estimation of food portions weight and the subjective perception of portion sizes. Through online questionnaires, the participants were asked to estimate the weight of pictured foods in the first study. In the (...) second study, the participants indicated how the depicted varying portion sizes of different meals relate to their actual consumed real-life portion sizes. A total of 725 and 436 individuals were included in the statistical analysis in the first and second study, respectively. BMI and gender had a small effect on the capacity to estimate the weight of foods. The main predictor for portion size choices was the factor gender with men estimating ideal portion sizes as larger than women. Further, age and hunger together with external and restrictive eating behaviors were among the deciding factors for portion size choices. As expected, externally motivated eaters chose bigger portions while restrictive individual smaller ones. Gender- and age-related differences in portion size preferences likely reflect distinct energy requirements. The individuals with a higher BMI do not differ strongly from other BMI groups in their portion-related preferences. Therefore, other factors such as meal frequency, snacking, or a lifestyle, may contribute more to the onset, development, and maintenance of overweight. (shrink)

ObjectiveThe aim of this study was to test the feasibility of telepsychology support for patients with severe cardiorespiratory disease and their caregivers. A secondary objective was to explore pre-post relationships between patients' and caregivers' clinical measures.MethodsA telehealth program incorporating telepsychology support, i.e., an “on-demand” phone service with a psychologist, was provided to consecutive cardiorespiratory patients at discharge from inpatient rehabilitation and to their caregivers. At the start and end of the 1-year program, participants were interviewed “face-to-face,” and their anxiety/depression level, (...) patients' quality of life, and caregivers' family strain and needs were assessed: we analyzed the correlations and evaluated customer satisfaction.ResultsOf 80 eligible individuals, 40 took part in this study: 22 patients and 18 caregivers. Eleven requested tele-psychological support, resulting in 51 consultations focused on anxiety, difficulty in patient management, worry about the patient's emotional state, and need for emotional support; 3 participants underwent a tailored psychotherapy program. All participants expressed high satisfaction with the service. At enrolment, anxiety was less evident in patients than in caregivers, while depressive symptoms were more evident, and correlated with MRF-28 and MQOL. Caregivers' FSQ showed a “strongly recommended” need for support; at enrolment, high levels of anxiety/depression were correlated with high FSQ ; depressive symptoms correlated negatively with age and positively with emotional needs ; anxiety was positively correlated with education level. At follow-up, patients' perception of support tended to increase, while caregivers' strain tended to decline. At enrolment, caregivers' anxiety/depression and strain correlated with patients' quality of life. At follow-up, caregivers' strain correlated with patients' quality of life and cognitive performance.ConclusionTelepsychology support associated with a telehealth service is feasible and satisfying for both participants and psychological management. A suitable support program can benefit both patients and caregivers, particularly those at higher risk of depressive symptoms and anxiety. (shrink)

Los avances científico-tecnológicos han abierto una brecha en cuanto a los tratamientos médicos y los valores morales que deben sustentar la atención de salud. El profesional de enfermería no está exento de estos peligros, por lo que se ha generado un nuevo modelo ético que se integre al proceso de atención de enfermería. Con el objetivo de determinar los conocimientos y opiniones de estos profesionales, del área de cirugía de mínimo acceso, acerca de la aplicación del modelo en el contexto (...) de estos servicios, se diseñó una investigación de tipo observacional descriptiva con empleo de metodología cualitativa. Como técnica de exploración se usó la entrevista en profundidad, así como un panel de expertos para la construcción de la guía de entrevista. Se entrevistó a 34 enfermeras que laboraban en el Centro Nacional de Cirugía de Mínimo Acceso durante el período del estudio. Se concluye que la práctica de la cirugía de mínimo acceso es propicia para que médicos y enfermeras hagan una mayor observancia del derecho de autonomía de los pacientes. Se reconoce la capacidad de este personal para tomar decisiones independientes de los médicos en cuanto a las acciones de cuidado, lo que implica una mayor responsabilidad. Scientific and technological advances have opened a gap between medical treatments and the moral values that should support health care. The nurse is not exempt from these dangers. As such, a new ethical model that integrates to the process of nursing care has emerged. In order to determine the knowledge and opinions of the professionals who work in minimal access surgery services on the implementation of this model, a descriptive, observational study was designed utilizing qualitative methodology. In-depth interviewing was used as the primary testing technique. A panel of experts from the National Center of Minimal Access Surgery was consulted to develop the interview guide. Thirty-four nurses from the National Center for Minimal Access Surgery were interviewed over the course of the study period. Results suggest that the setting of minimal access surgery is conducive to medical professionals making greater observance of the right to patient autonomy. The ability of this staff to make independent decisions regarding medical care action is recognized, which implies greater responsibility. (shrink)

Se realizó un estudio cuali-cuantitativo en la Comunidad Rural "El León" de la provincia de Camagüey. Se utilizó el método etnográfico y la evaluación del Análisis de la Situación de Salud en el periodo 2007-2015 con el objetivo de describir las características socio históricas y de salud de esta población, conjuntamente con profesionales de enfermería comunitaria. Se crearon instrumentos validados por expertos. Se aplicaron grupos focales, observación participante, entrevistas en profundidad a informantes clave, socioculturales, estructuradas abiertas y la cerrada para (...) combinarla con los resultados del Análisis de la Situación de Salud en el proceder cuantitativo. Se triangularon sus resultados. Se evidenció: falta de sentido de pertenencia de los pobladores, indisciplinas sociales que perjudican la comunidad y su salud, deterioro de las relaciones interpersonales, sistema eco cultural deficiente, y se identificó la necesidad de emprender otras acciones comunitarias que provoquen el cambio y modifiquen el cuadro de salud comunitaria. The quantitative and qualitative in the Community Rural accomplished a study itself "The Lion" of Camagüey's province. The 2007-2015 for the sake of describing the characteristics utilized the ethnographic method and the evaluation of Health's Analysis of the Situation in the period itself member historic and of health of this population together with nursing professionals, communal. They created instruments validated by experts. They applied focal groups, participating observation, you interview key, socio cultural to informants in depth, structured open and the closed to combine it with the results of Health's Analysis of the Situation in the quantitative action. They triangulated his results. It became evident: The inhabitants's pointlessness of possession, social indiscipline that the community and his health, deterioration of personal relations, system harm cultural deficient echo, and the need to undertake another communal actions was identified that they provoke the change and modify the picture of communal health. (shrink)

Se realizó una intervención comunitaria en el asentamiento rural "El León" de Camagüey basada en los resultados de un estudio anterior. Su objetivo fue implementar un sistema de acciones socio-sanitarias colectadas en un manual que organizó contenidos de antropología socio cultural, psicología y sociología de la salud, fue conducida por profesionales de enfermería cuyo encargo social les asigna una mayor permanencia e intercambio con los pobladores. Se potenció el trabajo comunitario a partir de febrero de 2010. La investigación constituyó un (...) diseño mixto, con un estudio cuasi experimental sin grupo control combinado con métodos cualitativos. La evaluación final efectuada en el periodo 2013-2015 exhibió modificaciones positivas en indicadores del Análisis de la Situación de Salud y el entorno comunitario. Se demostró la importancia de la aplicación de las acciones comunitarias por el personal de enfermería como agente de cambio de desarrollo local y protagonista de sostenibilidad. A community intervention was carried out at the rural settlement "El León". Its objective was to implement a system of actions led by nursing professionals whose social role assigns them longer permanence and interchange with the inhabitants of the community. Community work was fostered from February 2010 with social and sanitary actions based on socio-cultural anthropology, psychology and health sociology knowledge. The investigation had a mixed design, being a quasi-experimental study without control group combined with qualitative methods. The final evaluation, which took place from 2013-2015, showed positive modifications in Health Analysis indicators and community environment. The importance of the application of community actions by nursing personnel as agents of change for local development and sustainability leaders was demonstrated. (shrink)