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Clinical Ethics Committees (CECs), as distinct from Research Ethics Committees, were originally established with the aim of supporting healthcare professionals in managing controversial clinical ethical issues. However, it is still unclear whether they manage to accomplish this task and what is their impact on clinical practice. This systematic review aims to collect available assessments of CECs’ performance as reported in literature, in order to evaluate CECs’ effectiveness. We retrieved all literature published up to November 2019 in six databases (PubMed, Ovid (...) MEDLINE, Scopus, Philosopher’s Index, Embase and Web of Science), following PRISMA guidelines. We included only articles specifically addressing CECs and providing any form of CECs performance assessment. Twenty-nine articles were included. Ethics consultation was the most evaluated of CECs’ functions. We did not find standardized tools for measuring CECs’ efficacy, but 33% of studies considered “user satisfaction” as an indicator, with 94% of them reporting an average positive perception of CECs’ impact. Changes in patient treatment and a decrease of moral distress in health personnel were reported as additional outcomes of ethics consultation. The highly diverse ways by which CECs carry out their activities make CECs’ evaluation difficult. The adoption of shared criteria would be desirable to provide a reliable answer to the question about their effectiveness. Nonetheless, in general both users and providers consider CECs as helpful, relevant to their work, able to improve the quality of care. Their main function is ethics consultation, while less attention seems to be devoted to bioethics education and policy formation. (shrink)

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BackgroundVulnerability is a key concept in traditional and contemporary bioethics. In the philosophical literature, vulnerability is understood not only to be an ontological condition of humanity, but also to be a consequence of contingent factors. Within bioethics debates, vulnerable populations are defined in relation to compromised capacity to consent, increased susceptibility to harm, and/or exploitation. Although vulnerability has historically been associated with older adults, to date, no comprehensive or systematic work exists on the meaning of their vulnerability. To fill this (...) gap, we analysed the literature on aged care for the meaning, foundations, and uses of vulnerability as an ethical concept.MethodsUsing PRISMA guidelines, we conducted a systematic review of argument-based ethics literature in four major databases: PubMed, Embase®, Web of Science™, and Philosopher’s Index. These covered biomedical, philosophy, bioethical, and anthropological literature. Titles, abstracts, and full texts of identified papers were screened for relevance. The snowball technique and citation tracking were used to identify relevant publications. Data analysis and synthesis followed the preparatory steps of the coding process detailed in the QUAGOL methodology.ResultsThirty-eight publications met our criteria and were included. Publication dates ranged from 1984 to 2020, with 17 publications appearing between 2015 and 2020. Publications originated from all five major continents, as indicated by the affiliation of the first author. Our analyses revealed that the concept of vulnerability could be distinguished in terms of basic human and situational vulnerability. Six dimensions of older adults’ vulnerability were identified: physical; psychological; relational/interpersonal; moral; sociocultural, political, and economic; and existential/spiritual. This analysis suggested three ways to relate to older adults’ vulnerability: understanding older adults’ vulnerability, taking care of vulnerable older adults, and intervening through socio-political-economic measures.ConclusionsThe way in which vulnerability was conceptualised in the included publications overlaps with distinctions used within contemporary bioethics literature. Dimensions of aged care vulnerability map onto defining features of humans, giving weight to the claim that vulnerability represents an inherent characteristic of humans. Vulnerability is mostly a value-laden concept, endowed with positive and negative connotations. Most publications focused on and promoted aged care, strengthening the idea that care is a defining practice of being human. (shrink)

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In Italy, during the first wave of the Covid-19 pandemic, the Italian Society of Resuscitators and Pain Therapists (SIAARTI) and the Italian National Bioethics Committee (CNB) published ethical guidance on the allocation of scarce intensive care resources. In this paper, we outline and compare these documents in detail, highlighting differences and similarities. In particular, we argue that major differences exist with respect to the principles and values underpinning the documents and the normative allocation criteria proposed. Conversely, similarities can be traced (...) with respect to a functional rather than substantial endorsement of the age criterion, the importance of transparency, and the consideration over healthcare professionals’ responsibility regarding allocative decisions. In conclusion, we argue that Italy has lacked a comprehensive and publicly-accountable policy articulating principles and operational criteria geared to strengthen the “ethical preparedness” of the country in dealing with current and possible future public health emergencies. (shrink)

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We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the (...) major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials. (shrink)

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Traditional Informed Consent is becoming increasingly inadequate, especially in the context of research biobanks. How much information is needed by patients for their consent to be truly informed? How does the quality of the information they receive match up to the quality of the information they ought to receive? How can information be conveyed fairly about future, non-predictable lines of research? To circumvent these difficulties, some scholars have proposed that current consent guidelines should be reassessed, with trust being used as (...) a guiding principle instead of information. Here, we analyse one of these proposals, based on a Participation Pact, which is already being offered to patients at the Istituto Europeo di Oncologia, a comprehensive cancer hospital in Milan, Italy. (shrink)

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Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...) clinical trials are means to ends, and thus their moral status depends both on how well they perform as means to reach desired ends and on which ends they are meant to achieve. Building upon this normative framework in the next two sections we analyze the specific ethical issues raised by non-inferiority trials. By making it clear that clinical trials are just epistemic tools – i.e. means to certain ends – it is possible not only to clarify the conceptual debate over a fundamental issue in clinical research, but also to identify which ethically relevant considerations ought to be addressed in setting up a non-inferiority trial. (shrink)

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In their contribution, Kok et al raise a relevant, though often underestimated, issue: clinical ethics support services are often assumed to lead to an improvement of quality of care at the organisational level, but evidence in support of this claim is weak, if not completely lacking.1 Therefore, the authors propose a complex theoretical model connecting a specific kind of CESS, moral case deliberation, with mechanisms for quality of care improvement at the individual and the organisational level. The proposal is original, (...) and the topic discussed of great interest not only to practitioners and researchers dealing with CESS, but also to health policy-makers and managers of healthcare system, for all of whom it is indeed crucial to understand whether and how ethics support can positively impact quality of care. However, despite its undoubtful merits, we feel that some claims and model’s underlying assumptions might require in-depth scrutiny and more solid justification. i. First, the authors discuss two different approaches to understanding quality of care: the first approach, which they define as reductionist, interprets quality as an outcome-oriented, quantitative, and therefore, measurable function. The second approach defines quality …. (shrink)

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BackgroundCaregivers may play a fundamental role in the clinical pathway of cancer patients. They provide emotional, informational, and functional support as well as practical assistance, and they might help mediate the interaction and communication with the oncologists when care options are discussed, or decisions are made. Little is known about the impact of dyadic dynamics on patient-doctor communication, patient's satisfaction, or adherence to the therapies. This study protocol aims to evaluate the efficacy of a psychological support intervention on patients-caregivers relationship (...) and their alignment in the treatment decision-making process and estimate related improvement in patient' compliance/adherence to treatments.MethodsA total of 102 patients-caregivers' dyads will be involved, among breast and prostate cancer patients. The study entails a pre- post- evaluation through psychological questionnaires, with a randomization of participants in two conditions, the experimental one in which subjects participate in a psychological support consultation, and the control one, where dyads do not receive any intervention. A follow up after 6 months from the enrollment is planned.DiscussionA positive impact of the psychological support intervention on patients' anxiety, depression, distress, and perceived social support is expected. Such improvements can directly affect patients' satisfaction and adherence to treatments. Data gathered from this study may inform health care providers, policy makers, and public health managers about the importance of caregiver's involvement in the cancer care pathway, and the best way to manage it. A further impact is to develop a specific intervention protocol to support caregivers' involvement in cancer care pathway, improve patient's wellbeing, the interaction with physicians and the compliance with the cancer treatment. (shrink)

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Questions about human reproduction and parental responsibility run through our lives. They shape our experience as natal and mortal beings and orient our thinking about generation: the process by which we come to be; the activity in which we engage or choose not to engage as procreative beings; our syncopated sense of time; our responsibility for the continuity of human life on a finite and vulnerable planet. Like all living species, humans tend to reproduce. For this reason, assumptions abou...

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BackgroundClinical Ethics Support Services have been established to support healthcare professionals in addressing ethically sensitive issues in clinical practice and, in many countries, they are under development. In the context of growing CESS, exploring how healthcare professionals experience and address clinical ethics issues in their daily practice represents a fundamental step to understand their potential needs. This is even more relevant in the context of extremely sensitive diseases, such as cancer. On this basis, we carried out a qualitative study conducting (...) in-depth semi-structured interviews with stakeholders of a major comprehensive cancer centre in Italy, with the twofold aim of investigating what ethical issues arise in the context of clinical oncology and how they are addressed, as well as stakeholders’ expectations about a potential CESS to be implemented within the Institution.MethodsThe study was conducted within the theoretical framework of Grounded Theory. Participants were healthcare professionals and other key stakeholders working within the cancer centre. The semi-structured interview aimed at exploring common ethical aspects of oncology, investigating stakeholders’ professional experience in dealing with clinical ethics issues, their expectations and requests regarding ethics support services. Transcripts of the interviews were coded and analysed according to the principles of Grounded Theory.ResultsTwenty-one stakeholders were interviewed. Our analysis showed a wide consensus on the identification of ethically relevant issues, above all those concerning communication, end-of-life, and resource allocation. The absence of institutional tools or strategies to address and manage ethical issues at the patient bedside emerged, and this is reflected in the widespread request for their development in the future. The ideal support service should be fast and flexible in order to adapt to different needs and clinical cases.ConclusionsThe interviewees showed a limited degree of ‘ethical awareness’: despite having reported many issues in clinical practice, they could hardly identify and describe the ethical aspects, while complaining about a lack of ethical resources in their management. To build a truly effective support service, it therefore seems appropriate to take such context into consideration and address the emerged needs. Ethical sensitivity seems to be key and it becomes even more relevant in critical clinical areas, such as the therapeutic pathways of terminally ill patients. (shrink)

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Background. Since the nineties, policymakers and theorists working across several disciplines started to entertain the notion of directly engaging the public in matters of public concern. Accompanying this was the attempt to resort to deliberative democracy in order to make such an involvement effective. Seizing on its intrinsic dialogic nature, some scholars proposed the application of public deliberation to the realm of public bioethics. Drawing upon the theory and practice of deliberative public bioethics, the purpose of this paper is to (...) shed light onto the figure of the bioethical expert and its role in public bioethics, and relatedly, to investigate how deliberation may be implemented in a public bioethics context. Methods. We set up a large-scale experiment to investigate whether, and to what extent, different moderation styles impact on participants’ moral preferences. The study combines a survey of a representative sample of the general population with a laboratory experiment based on a random sample of students that ex-ante has identical attitudes to the general population.Results. Findings show that: i) different moderation styles can significantly influence deliberative outcomes; iii) the effects of deliberation are not necessarily immediate, but may be revealed after the end of deliberative session; iii) participants tend to better appreciate a bioethical expert acting as “passive moderator”, namely as someone who acts in order to ensure non-domination and non-interference, thus allowing the creation of basic conditions for equality within the deliberative setting.Conclusions. Our experiment represents an example of how deliberation can be employed in public bioethics. (shrink)

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