Over the past several years, healthcare has been profoundly altered by the growth of managed care. Because managed care integrates the financing and delivery of healthcare services, it dramatically alters the roles and relationships among providers, payers, and patients. While analysis of this change has focused on whether and how managed care can control costs, an increasingly important concern among healthcare providers and recipients is the impact of managed care on the physicianpatient relationship, but little data have been collected (...) and analyzed. We designed a survey for distribution to Wisconsin physicians to analyze the prevalence and types of managed care arrangements in the state, and the impact of these arrangements on physicians and their relationships with patients. (shrink)

There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient’s rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient (...) class='Hi'>data, i.e. healthcare professionals, regulators and policy makers. We used a qualitative design to examine Swiss healthcare stakeholders’ experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries’ patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients’ rights and citizens’ involvement on the other. The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

BACKGROUND: There is a growing interest in aggregating more biomedical and patient data into large health data sets for research and public benefits. However, collecting and processing patient data raises new ethical issues regarding patient's rights, social justice and trust in public institutions. The aim of this empirical study is to gain an in-depth understanding of the awareness of possible ethical risks and corresponding obligations among those who are involved in projects using patient (...) data, i.e. healthcare professionals, regulators and policy makers. METHODS: We used a qualitative design to examine Swiss healthcare stakeholders' experiences and perceptions of ethical challenges with regard to patient data in real-life settings where clinical registries are sponsored, created and/or used. A semi-structured interview was carried out with 22 participants (11 physicians, 7 policy-makers, 4 ethical committee members) between July 2014 and January 2015. The interviews were audio-recorded, transcribed, coded and analysed using a thematic method derived from Grounded Theory. RESULTS: All interviewees were concerned as a matter of priority with the needs of legal and operating norms for the collection and use of data, whereas less interest was shown in issues regarding patient agency, the need for reciprocity, and shared governance in the management and use of clinical registries' patient data. This observed asymmetry highlights a possible tension between public and research interests on the one hand, and the recognition of patients' rights and citizens' involvement on the other. CONCLUSIONS: The advocation of further health-related data sharing on the grounds of research and public interest, without due regard for the perspective of patients and donors, could run the risk of fostering distrust towards healthcare data collections. Ultimately, this could diminish the expected social benefits. However, rather than setting patient rights against public interest, new ethical approaches could strengthen both concurrently. On a normative level, this study thus provides material from which to develop further ethical reflection towards a more cooperative approach involving patients and citizens in the governance of their health-related big data. (shrink)

When it comes to using patient data from the National Health Service for research, we are often told that it is a matter of trust: we need to trust, we need to build trust, we need to restore trust. Various policy papers and reports articulate and develop these ideas and make very important contributions to public dialogue on the trustworthiness of our research institutions. But these documents and policies are apparently constructed with little sustained reflection on the nature (...) of trust and trustworthiness, and therefore are missing important features that matter for how we manage concerns related to trust. We suggest that what we mean by ‘trust’ and ‘trustworthiness’ matters and should affect the policies and guidance that govern data sharing in the NHS. We offer a number of initial, general reflections on the way in which some of these features might affect our approach to principles, policies and strategies that are related to sharing patient data for research. This paper is the outcome of a ‘public ethics’ coproduction activity which involved members of the public and two academic ethicists. Our task was to consider collectively the accounts of trust developed by philosophers as they applied in the context of the NHS and to coproduce an argumentative position relevant to this context. (shrink)

For over a decade, managed care has profoundly altered how healthcare is delivered in the United States. There have been concerns that the patient-physician relationship may be undermined by various aspects of managed care, such as restrictions on physician choice, productivity requirements that limit the time physicians may spend with patients, and the use of compensation formulas that reward physicians for healthcare dollars not spent. We have previously published data on the effects of managed care on the physician- (...) class='Hi'>patient relationship from the physician's perspective. In 1999, we collected data on the impact of managed care arrangements on the physician-patient relationship from the patient's perspective. This article discusses our collective findings. (shrink)

This study aimed to explore the conditions for nurses' daily patient education work by focusing on managers' way of speaking about the patient education provided by nurses in hospital care. An explorative, qualitative design with a social constructionist perspective was used. Data were collected from three focus group interviews and analysed by means of critical discourse analysis. Discursive practice can be explained by the ideology of hegemony. Due to a heavy workload and lack of time, managers could (...) ‘see’ neither their role as a supporter of the patient education provided by nurses, nor their role in the development of nurses' pedagogical competence. They used organisational, financial, medical and legal reasons for explaining their failure to support nurses' provision of patient education. The organisational discourse was an umbrella term for ‘things’ such as cost‐effectiveness, which were prioritised over patient education. There is a need to remove managerial barriers to the professional development of nurses' patient education. Managers should be responsible for ensuring and overseeing that nurses have the prerequisites necessary for providing patient education as well as for enabling continuous reflective dialogue and opportunities for learning in practice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Managing the Transition from Patient-Centered Care to ProtocolDavid SlakterI learned that I would need a kidney transplant in the summer of 2015. This was not a complete surprise to me, as I had been subjected to a number of tests and invasive procedures to investigate nephritis since I was a child. I had heard similar stories of clinicians performing repeated tests on my father for similar reasons without (...) any conclusions. Following my recommendation for transplant and consultation with genomics specialists, the cause of my kidney failure was determined to be Alport syndrome. What made Alport syndrome so difficult to diagnose in my case was that the associated mutation is a rare, autosomal-dominant one that has only recently been associated with the condition.After reviewing the data on survival rates for transitioning to dialysis versus a transplant, my family and I then considered the success rates for living versus cadaver donors, and the success rates at various transplant centers. The current data favor the long-term outcomes of transplant over dialysis and living over cadaver donors. Since we had decided to focus on searching for a live donor, my nephrologist recommended contacting Renewal, an organization that specializes in connecting those in need of a kidney transplant with live donors and providing support for donors to make the donation process less burdensome.On Renewal’s recommendation, my family and friends reached out across their social networks to search for potential donors. Many of those tested for compatibility were eliminated on basic matching criteria, others due to previously undiagnosed medical problems. Finally, the wife of a childhood friend came forward as an eligible donor and was also an incredibly close match on the antigens tested for kidney transplants.Having a living donor who was also a friend made the transplant experience somewhat less intimidating than it might have been. It meant the transformation of an existing relationship with someone already close to me, with fewer open questions about what may have motivated them to be so generous than if the donor had been someone I did not know. It also meant our families could be together in the waiting room, and that we shared in each other’s recoveries.Life post-transplant has been a significant improvement from what it was like immediately beforehand. Before my transplant, I regularly weighed food and consulted nutrition charts to gauge how much potassium I was consuming. To prevent too much potassium from building up in my bloodstream, I had to take sodium polystyrene [End Page 111] regularly. As one might guess from the name, it tastes much like burnt Styrofoam, and I could only ingest it with copious amounts of fruit-flavored syrup (strawberry covered up the awful flavor the best). There are other potassium binders on the market now, so fewer people with kidney failure will likely need to engage in such gustatory experimentation.I was also able to engage in more activities than what was possible even years before my transplant. I had long experienced difficulty with aerobic exercises, but assumed the reason was merely being out of shape. Though I have always walked regularly, even the one-mile walk from my office to my apartment had become a chore by the end. Within a few months after my transplant, I was riding a bicycle all over NYC, from Harlem to Brooklyn and back regularly, and hiking trails in nearby state parks. I began sessions with a personal trainer and attained a level of fitness I had not reached since I played soccer as a child.The transition from personalized care to one more driven by protocol has been a surprising and challenging aspect of the transplant process. While my previous experience with medical treatment has been individual meetings with physicians, my post-transplant care is managed by a team of nephrologists and other specialists in transplant care. My initial transplant nephrologist was automatically assigned to me. Because the standard of care for transplant patients is often driven by protocol, my assigned nephrologist recommended a biopsy on my transplanted kidney due to results in my recent lab tests. When pressed on the necessity of a biopsy in my case versus... (shrink)

Recent data breaches underscore the importance of organizational cybersecurity. However, the high costs of such security can force chief financial officers (CFOs) to make difficult financial and ethical trade-offs that have both business and societal implications. We employ a 2 × 2 randomized experiment that varies both an observed scenario CFO’s investment decision (invest/not invest in security) and organizational outcomes (positive/negative) to investigate these trade-offs. Participant managers assess the observed CFO’s investment behavior and indicate their own intentions to (...) invest. Results indicate that when the observed scenario CFO invests in security, managers primarily follow their peers when making investment decisions. However, when the observed CFO does not invest in security, managers make their own decisions by engaging in more in-depth reasoning that includes assessment of the seriousness of consequences, as well as the ethical and societal considerations. Moderated mediation findings further deconstruct and corroborate these relationships. (shrink)

ABSTRACT Patient self‐management (SM) of chronic disease is an evolving movement, with some forms documented as yielding important outcomes. Potential benefits from proper preparation and maintenance of patient SM skills include quality care tailored to the patient's preferences and life goals, and increase in skills in problem solving, confidence and success, generalizable to other parts of the patient's life. Four central ethical issues can be identified: 1) insufficient patient/family access to preparation that will optimize (...) their competence to SM without harm to themselves, 2) lack of acknowledgement that an ethos of patient empowerment can mask transfer of responsibility beyond patient/family competency to handle that responsibility, 3) prevailing assumptions that preparation for SM cannot result in harm and that its main purpose is to deliver physician instructions, and 4) lack of standards for patient selection, which has the potential to exclude individuals who could benefit from learning to SM. Technology assessment offers one framework through which to examine available data about efficacy of patient SM and to answer the central question of what conditions must be put in place to optimize the benefits of SM while assuring that potential harms are controlled. (shrink)

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was (...) fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions. (shrink)

The arts provide openings for symbolic expression by engaging the sensory experience in the body they become a source of insight through embodied cognition and emotion, enabling meaning-making, and acting as a catalyst for change. This synthesis of sensation and enactive, embodied expression through movement and the arts is capitalized on in The BodyMind Approach®. It is integral to this biopsychosocial, innovative, unique intervention for people suffering medically unexplained symptoms applied in primary healthcare. The relevance of embodiment and arts practices (...) in TBMA are discussed in relation to the views of participants in the pursuit of self-management. If widely employed TBMA could have an enormous impact, reach, and significance for patients and global health services. This original pre-clinical trial of qualitative research reports on the perceptions of participant patients with generic MUS, a world-wide issue usually treated by either psychological therapy or physiotherapy. TBMA is not a therapy but a health education program founded upon the concept of an integration of psychological elements with physiological, bodily, and sensory experiences. Thematic analysis of qualitative data sets from open-ended questions in semi-structured interviews and a written questionnaire post intervention is presented. Five aspects which appear to be key to learning self-management were derived from analyzing the data: body with mind connections; importance of facilitation; potential benefits; preparedness for change; self-acceptance/compassion. This article advances the discourse on the nature of self-management for MUS through changing the mind-set and the relationship participants have with their bodily symptom/s through employing embodied methods and arts practices, challenging current, and solely verbal, psychological conceptual frameworks. Rigor lies in the method of data analysis using cross verification of credibility between reported findings and scrutiny by stakeholders. We conclude that facilitated TBMA groups employing embodied methods and arts practices can act as a method for developing the self-management of MUS and improving wellbeing. (shrink)

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients and managers ; semi-structured interviews with managers, clinicians, and ethics committee chairpersons. Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints (...) on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions. (shrink)

Healthcare cybersecurity is increasingly targeted by malicious hackers. This sector has many vulnerabilities and health data is very sensitive and valuable. Consequently, any damage caused by malicious intrusions is particularly alarming. The consequences of these attacks can be enormous and endanger patient care. Amongst the already-implemented cybersecurity measures and the ones that need to be further improved, this paper aims to demonstrate how penetration tests can greatly benefit healthcare cybersecurity. It is already proven that this (...) approach has enforced cybersecurity in other sectors. However, it is not popular in healthcare since many prejudices still surround the hacking practice and there is a lack of education on hackers’ categories and their ethics. The present analysis aims to comprehend what hacker ethics is and who ethical hackers are. Currently, hacker ethics has the status of personal ethics; however, to employ penetration testers in healthcare, it is recommended to draft an official code of ethics, comprising principles, standards, expectations, and best practices. Additionally, it is important to distinguish between malicious hackers and ethical hackers. Amongst the latter, penetration testers are only a sub-category. Acknowledging the subtle differences between ethical hackers and penetration testers allows to better understand why and how the latter can offer their services to healthcare facilities. (shrink)

It is reasonable to consider and trust that information taken from us about our medical health and history will be protected by rules on confidentiality and consent. Apart from very rare cases, perhaps of major public interest or for public health reasons, this information will not be shared with others without our consent. However, both a number of reforms in National Health Service patient data management policy (now enshrined in legislation) and developments in the general law on (...) privacy challenge this traditional view of our control and choice over our medical information, as this article will show. In doing so, it analyses the question as to whether in spite of the rhetoric do any of us now really have choice over the access to and use of our medical data? In reality, our choices are limited and in any relationship of trust and shared decision making this ought to be transparent. (shrink)

The impact of managed care on nurses’ workplace learning and teaching This paper examines the impact of managed care on the informal learning process for nurses in a major US‐based health organisation. Through the analysis of focus group data we report the nurses’ view of the effect recent changes have had on the nurse/patient/care relationship. Managed care, our research indicates, has transformed the learning milieus for nurses with two effects. First, nurses have seen their need for informal learning (...) increase while the time and context for that learning has diminished. Second, the process of teaching patients and families has also been adversely affected even as managed care creates the need for more patient education. We report the analysis of the data collected at group interviews involving nurses working in both hospital and community settings of a leading US‐based HMO. All interviews took place during September of 1997 at various sites in California. This study is part of a larger Social Science Research Council of Canada funded investigation into managed care in the US and Canada. (shrink)

Two articles in this issue of the Hastings Center Report explore two sides of the same problematic coin. In “The Limits of Surrogates’ Moral Authority and Physician Professionalism,” Jeffrey Berger discusses the moral problem of a surrogate refusing a treatment, palliative sedation, on behalf of a patient whose suffering is refractory to intensive palliative efforts provided by a multidisciplinary team. In “After the DNR: Surrogates Who Persist in Requesting Cardiopulmonary Resuscitation,” Ellen Robinson and her colleagues analyze data from (...) a study of cases in which physicians wished not to perform cardiopulmonary resuscitation on patients whom they thought it would harm. Both articles begin from the idea of a professional determination about a physician's duty to a patient that conflicted with a surrogate's determination about what should or should not be done for that patient. Berger's argument stops just short of a solution, however, because a physician's professional obligation to help patients, even within guidelines set by other professionals, is insufficient protection for patients. But if Berger's theory is right—that sometimes surrogates lack moral authority to make decisions on behalf of patients—then the Robinson team has developed a careful and public process for attending to that conflict. (shrink)

When plastic surgeons meet with new cosmetic surgery clients, they routinely try to get patients to `sign up' for elective surgery without forcing or pressuring them to do it. On rare occasions, they face a prospective client who, in the course of interaction, signals possible legal or medical risks, thereby calling on the surgeon to screen the client more vigilantly to determine whether embarking on cosmetic surgery will be reasonable. Grounded against nine-month field work at a cosmetic surgery center, combined (...) with 30+ hours of videotaped data of initial consultations, this article investigates a unique situation in which a 74-year-old woman seeking rhinoplasty and rhytidectomy is perceived as a difficult customer. Why this moment was interpreted and emerged as difficult is the analytic focus of the article. Using action-implicative discourse analysis, the analysis describes five communication challenges the plastic surgeon faced in the course of the 60-minute encounter. In the article's conclusion, I reflect on what seems to be a central issue for plastic surgeons: to act as gatekeepers of a fully elective and pricy surgery in a service-oriented business. (shrink)

The frequency of conflicts with patients' families is one of the main contributors to the amount of emotional demands that healthcare professionals must tackle to prevent the occurrence of burnout symptoms. On the other hand, research evidence suggests that hardiness could enable healthcare professionals to handle their responsibilities and problems effectively. Based on the health impairment process of the Job Demands-Resources model, the main goal of this study was to delve deeper into the relationship between conflict with patients’ families, emotional (...) demands and exhaustion, as well as to test the buffering role of hardiness. Data were collected on a sample of N= 295 healthcare professionals working in a private hospital in Northern Italy. Most of them were women (78.6%) with a mean age of 40.62 years (SD = 9.50). The mediation of emotional demands within the association between conflict with families and emotional exhaustion and the moderating role of hardiness were tested using a bootstrapping approach. In the current sample, emotional demands mediated the association between conflict with families and exhaustion among healthcare professionals. Moreover, this relationship decreased among individuals with higher levels of hardiness. These findings contribute to the current understanding of the negative impact played by conflict with families on healthcare professionals' psychological wellbeing. Furthermore, they corroborated the role of hardiness as a personal resource that could prevent the occurrence of burnout symptoms. In addition to manage – and decrease – episodes of conflict with patients and their families, organizations in the healthcare sector should develop interventions aimed at fostering employees' hardiness and, consequently, tackle job demands ingrained in their profession (i.e., emotional demands). (shrink)

The increased complexity of health information management sows the seeds of inequalities between health care stakeholders involved in the production and use of health information. Patients may thus be more vulnerable to use of their data without their consent and breaches in confidentiality. Health care providers can also be the victims of a health information system that they do not fully master. Yet, despite its possible drawbacks, the management of health information is indispensable for advancing science, medical (...) care and public health. Therefore, the central question addressed by this paper is how to manage health information ethically? This article argues that Paul Ricœur’s ‘‘little ethics’’, based on his work on hermeneutics and narrative identity, provides a suitable ethical framework to this end. This ethical theory has the merit of helping to harmonise self-esteem and solicitude amongst patients and healthcare providers, and at the same time provides an ethics of justice in public health. A matrix, derived from Ricœur’s ethics, has been developed as a solution to overcoming possible conflicts between privacy interests and the common good in the management of health information. (shrink)

Introduction Expressions of Managerial ethics as a clinical phenomenon in Nursing Ethics as expressed by nurse managers were investigated. A coherence could be detected between the concepts and phenomena of Managerial ethics and nurse managers as a context. Background Managerial ethics as a new approach has emerged in the perspective and by prioritizing ethics in the organization has provided the basis for creating and promoting individual and organizational effectiveness. Managers’ and staff’s adherence to professional ethics helps hospitals to achieve their (...) intended goals. Aim The present study aimed to explain nurse managers’ experience of managerial ethics. Research design This qualitative study was conducted based on a phenomenological design in 2022. Participants and research context The participants included 20 nurse managers working in hospitals in Arak, Iran. They were selected by the purposive sampling method which continued until data saturation. Data were collected through semi-structured individual interviews (30–90 min); subsequently, the obtained results were analyzed using the Van Manen six-step approach. Ethical considerations The confidentiality and the right of participants to take part or withdraw from the study were observed during this research. Results The results of the present study were able to demonstrate nurse managers’ lived experience of managerial ethics in the form of five themes of professional ethics, people-oriented management, professional empowerment, excellencism, and patient-centered care. Conclusions As evidenced by the obtained results, nurse managers held a positive view of managerial ethics. They were striving to strongly adhere to ethical principles in nursing management since they contribute greatly to the improved quality of nursing services in care and health settings. Therefore, appropriate policy-making and planning for managerial ethics training are indispensable for all nurses and nursing students. (shrink)

While the implementation of digital technology in psychiatry appears promising, there is an urgent need to address the implications of the absence of ethical design in the early development of such technologies. Some authors have noted the gap between technology development and ethical analysis and have called for an upstream examination of the ethical issues raised by digital technologies. In this paper, we address this suggestion, particularly in relation to digital healthcare technologies for patients with schizophrenia spectrum disorders. The introduction (...) of digital technologies in psychiatry offers a broad spectrum of diagnostic and treatment options tailored to the health needs and goals of patients’ care. These technologies include wearable devices, smartphone applications for high-immersive virtual realities, smart homes, telepsychiatry and messaging systems for patients in rural areas. The availability of these technologies could increase access to mental health services and improve the diagnostics of mental disorders.Additional Instruction AbstractIn this descriptive review, we systematize ethical concerns about digital technologies for mental health with a particular focus on individuals suffering from schizophrenia. There are many unsolved dilemmas and conflicts of interest in the implementation of these technologies, such as (1) the lack of evidence on efficacy and impact on self-perception; (2) the lack of clear standards for the safety of their daily implementation; (3) unclear roles of technology and a shift in the responsibilities of all parties; (4) no guarantee of data confidentiality; and (5) the lack of a user-centered design that meets the particular needs of patients with schizophrenia. mHealth can improve care in psychiatry and make mental healthcare services more efficient and personalized while destigmatizing mental health disorders. To ensure that these technologies will benefit people with mental health disorders, we need to heighten sensitivity to ethical issues among mental healthcare specialists, health policy makers, software developers, patients themselves and their proxies. Additionally, we need to develop frameworks for furthering sustainable development in the digital technologies industry and for the responsible usage of such technologies for patients with schizophrenia in the clinical setting. We suggest that digital technology in psychiatry, particularly for schizophrenia and other serious mental health disorders, should be integrated into treatment with professional supervision rather than as a self-treatment tool. (shrink)

This study addresses the current lack of empirical data on the experiences and attitudes of clinical research professionals towards AI-powered clinical trial management tools. Clinical research professionals affiliated with various Swiss and international clinical research networks were invited to participate in an online survey. The survey focused on nine use cases of AI-powered clinical trial management tools. Participants were asked to share their ethical considerations, and their experiences were assessed at both the individual and institutional levels. Answers (...) from 110 participants, primarily from Swiss academic institutions, were included in the data analysis. While participants generally held positive attitudes, mixed views were also common. Governmental attitudes were widely perceived as unclear or cautious, with the associated regulatory opacity possibly contributing to the limited adoption of AI in trial management observed in this study. In addition to a clear AI governance, ethical compliance and training emerged as crucial aspects. There was also broad consensus on the necessity of informing patients about tools’ uses and of ensuring an independent certification of the respective tools. The widespread adoption of AI-powered clinical trial management tools remains distant, entangled in a net of complexities that require further empirical investigation. Ethical concerns appear to play a crucial role, driven by distrust and the absence of a clear regulatory framework. Urgent actions are needed at both institutional and governmental levels, including the establishment of a governance framework and training provision. (shrink)

The basic components of data management including data ownership, collection, selection, recording, analysis, storage, retention, destruction, and sharing. A number of important principles underlie best practices for each of these components; these include recording details such that another can repeat the experiment, keeping the data safe, managing storage in such a way as to facilitate easy retrieval for the period of time required by regulatory agencies and establishing data sharing principles with colleagues before collaborations begin. (...) Experience as practicing scientists and teachers has aided in developing helpful strategies and approaches for communicating these principles, policies and practices to trainees and colleagues. We recommend didactic instruction focused by discipline, combined with the use of teachable moments in a student’s career, as well as teaching principles versus rules, because changing methods of data collection and storage have implications for data management practices. (shrink)

With the powerful analyses and resources they enable, digital humanities tools have captivated researchers from many different fields who want to use them to study science. Digital tools, as well as funding agencies, research communities, and academic administrators, require researchers to think carefully about how they conceptualize, manage, and store data, and about what they plan to do with that data once a given project is over. The difficulties of developing strategies to address these problems can prevent new (...) researchers from sticking with digital tools and flummox even experienced researchers. To help overcome the data hurdle, we present five principles to help researchers, novice and experienced alike, conceptualize and plan for their data. We illustrate the use of those principles with two digital projects from the history of science, the Embryo Project and the Marine Biological Laboratory History Project, and their associated HPS Repository for data. The principles apply beyond the digital realm, so those who collect and manage data by more traditional means will also find them useful. (shrink)

By examining managers’ decisions about disclosing updated assessments of firms’ risks, we present evidence that the risk factor disclosures are informative. We use the setting of cybersecurity risk factor disclosures after a data breach because data breaches, especially severe breaches, serve as a natural experiment where an exogenous shock to managers’ assessment of their firm’s cybersecurity risks occurs. We analyze the topic from the perspective of two different theoretical lenses: the economic lens of optimal risk exposure (...) and the ethical lens of stakeholder theory. Using a sample of firms experiencing data breaches, we find that firms experiencing a data breach increase the amount of cybersecurity risk factor disclosures compared to matched firms with no data breach. Further investigation reveals that the severity of data breaches affects the results; cybersecurity risk factor disclosures increase only after severe data breaches. While there is no significant market reaction if breached firms’ subsequent annual reports include increased cybersecurity risk factor disclosures, a significant negative market reaction occurs if breached firms decrease cybersecurity risk factor disclosures, regardless of the severity of the breach, implying that the market anticipates increased disclosures after data breaches. (shrink)

For public health professionals, traumatic brain injury and its possible protracted repercussions are a significant source of worry. In opposed to patient neurorehabilitation with developed brain abnormalities of different etiologies, neurorehabilitation of affected persons has several distinct features. The clinical repercussions of the various types of TBI injuries will be discussed in detail in this paper. During severe TBI, the medical course frequently follows a familiar first sequence of coma, accompanied by disordered awareness, followed by agitation and forgetfulness, followed (...) by return of function. Clinicians must be aware of common medical issues that might occur throughout the various stages of neurorehabilitation, for example, posttraumatic hydrocephalus, paroxysmal sympathetic hyperactivity and posttraumatic neuroendocrine disorders, at each step of the process. Furthermore, we address problems about the scheduling of various rehabilitation programs as well as the availability of current data for comprehensive rehabilitative neuropsychology techniques. (shrink)

Heuser, Eller and Byrne provide important descriptive ethics data about how physicians counsel women on the clinical management of pregnancies complicated by severe fetal anomalies. The authors present an account of what such counselling ought to be based on, the ethical concept of the fetus as a patient and the professional responsibility model of obstetric ethics. When there is certainty about the diagnosis and either a very high probability of either death as the outcome of the anomaly (...) or survival with severe and irreversible deficit of cognitive developmental capacity as a result of the anomaly diagnosed, the pregnant woman should be offered the alternatives of aggressive and non-aggressive obstetric management and induced abortion before viability. It is also ethically permissible to offer feticide followed by termination of pregnancy after viability in such cases. This ethically justified approach will reduce the variation in the actual practices of specialists in maternal–fetal medicine described by Heuser, Eller and Byrne. (shrink)

Low levels of public trust in data practices have led to growing calls for changes to data-driven systems, and in the EU, the General Data Protection Regulation provides a legal motivation for such changes. Data management is a vital component of data-driven systems, but what constitutes ‘good’ data management is not straightforward. Academic attention is turning to the question of what ‘good data’ might look like more generally, but public views are (...) absent from these debates. This paper addresses this gap, reporting on a survey of the public on their views of data management approaches, undertaken by the authors and administered in the UK, where departure from the EU makes future data legislation uncertain. The survey found that respondents dislike the current approach in which commercial organizations control their personal data and prefer approaches that give them control over their data, that include oversight from regulatory bodies or that enable them to opt out of data gathering. Variations of data trusts – that is, structures that provide independent stewardship of data – were also preferable to the current approach, but not as widely preferred as control, oversight and opt out options. These features therefore constitute ‘good data management’ for survey respondents. These findings align only in part with principles of good data identified by policy experts and researchers. Our findings nuance understandings of good data as a concept and of good data management as a practice and point to where further research and policy action are needed. (shrink)

Informed consent bears significant relevance as a legal basis for the processing of personal data and health data in the current privacy, data protection and confidentiality legislations. The consent requirements find their basis in an ideal of personal autonomy. Yet, with the recent advent of the global pandemic and the increased use of eHealth applications in its wake, a more differentiated perspective with regards to this normative approach might soon gain momentum. This paper discusses the compatibility of (...) a moral duty to share data for the sake of the improvement of healthcare, research, and public health with autonomy in the field of data protection, privacy and medical confidentiality. It explores several ethical-theoretical justifications for a duty of data sharing, and then reflects on how existing privacy, data protection, and confidentiality legislations could obstruct such a duty. Consent, as currently defined in the General Data Protection Regulation – a key legislative framework providing rules on the processing of personal data and data concerning health – and in the recommendation of the Council of Europe on the protection of health-related data – explored here as soft-law – turns out not to be indispensable from various ethical perspectives, while the requirement of consent in the General Data Protection Regulation and the recommendation nonetheless curtails the full potential of a duty to share medical data. Also other legal grounds as possible alternatives for consent seem to constitute an impediment. (shrink)

Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly discussed in the literature (...) as an issue for senior doctors and research directors. Limitations of professional equipoise are reviewed, and data on the neglected topic of patients' equipoise are reported using the example of breast cancer trials. In theory, a patient who gives informed and voluntary consent to enter a randomised trial has achieved the equilibrium of equipoise. In practice, equipoise among patients ranges from personal to proxy acceptance. (shrink)

With the rapid growth of information technology and sports, analyzing sports information has become an increasingly challenging issue. Sports big data come from the Internet and show a rapid growth trend. Sports big data contain rich information such as athletes, coaches, athletics, and swimming. Nowadays, various sports data can be easily accessed, and amazing data analysis technologies have been developed, which enable us to further explore the value behind these data. In this paper, we first (...) introduce the background of sports big data. Secondly, we review sports big data management such as sports big data acquisition, sports big data labeling, and improvement of existing data. Thirdly, we show sports data analysis methods, including statistical analysis, sports social network analysis, and sports big data analysis service platform. Furthermore, we describe the sports big data applications such as evaluation and prediction. Finally, we investigate representative research issues in sports big data areas, including predicting the athletes’ performance in the knowledge graph, finding a rising star of sports, unified sports big data platform, open sports big data, and privacy protections. This paper should help the researchers obtaining a broader understanding of sports big data and provide some potential research directions. (shrink)

Greenblum and Hubbard argue that physicians are duty-bound by the constraints of Rawlsian ‘public reason’ to avoid engaging their patients’ religious considerations in medical decision-making.1 This position offers a number of appealing benefits to physicians. It will appear plausible because Rawls’s philosophical tradition of Political Liberalism enjoys the status of ideological orthodoxy in institutions tasked with forming the moral imaginations of physicians and other elites.2 3 It casts the physician in the role of a ‘reasonable person’ occupying the space of (...) public reason whose medical and ethical judgments are opposed by ‘sectarian’ religious patients who refuse to be reasonable. This narrative authorises the exclusion of patient religious considerations from medical decision making when they do not ‘translate’ into reasons recognised by ‘reasonable’ medical professionals and manages the trauma of overwhelmed physicians by legitimising disengagement from difficult interactions with religious patients. The authors’ arguments depend on concepts from Rawls’s Political Liberalism 4 and are presented as if the premises of Liberal theory are incontestable—despite the fact that a large body of philosophical literature challenging its premises and core concepts has existed for decades.3 5–7 This ‘nothing to see here, move along’ approach saves more space for anecdotes about religious people, at which …. (shrink)

The use of patient restrictions (e.g. involuntary admission, seclusion, restraint) is a complex ethical dilemma in psychiatric care. The present study explored nurses’ (n = 22) and physicians’ (n = 5) perceptions of what actually happens when an aggressive behaviour episode occurs on the ward and what alternatives to seclusion and restraint are actually in use as normal standard practice in acute psychiatric care. The data were collected by focus group interviews and analysed by inductive content analysis. The (...) participants believed that the decision-making process for managing patients’ aggressive behaviour contains some in-built ethical dilemmas. They thought that patients’ subjective perspective received little attention. Nevertheless, the staff proposed and appeared to use a number of alternatives to minimize or replace the use of seclusion and restraint. Medical and nursing staff need to be encouraged and taught to: (1) tune in more deeply to reasons for patients’ aggressive behaviour; and (2) use alternatives to seclusion and restraint in order to humanize patient care to a greater extent. (shrink)

Patient portals are poised to transform health communication by empowering patients with rapid access to their own health data. The 21st Century Cures Act is a US federal law that, among other provisions, prevents health entities from engaging in practices that disrupt the exchange of electronic health information—a measure that may increase the usage of patient health portals. Caregiver access to patient portals, however, may lead to breaches in patient privacy and confidentiality if not managed (...) properly through proxy accounts. We present an ethical framework that guides policy and clinical workflow development for healthcare institutions to support the best use of patient portals. Caregivers are vital members of the care team and should be supported through novel forms of health information technology (IT). Patients, however, may not want all information to be shared with their proxies so healthcare institutions must support the development and use of separate proxy accounts as opposed to using the patient’s own account as well provide controls for limiting the scope of information displayed in the proxy accounts. Lastly, as socioeconomic barriers to adoption of health IT persist, healthcare providers must work to ensure multiple streams of patient communication, to prevent further propagating health inequities. (shrink)

Introduction: Mental health nursing is dependent on nurses’ ability to engage in therapeutic relationships with patients. The ability to manage professional boundaries is equally important, but less explored. This study aims to address the following research questions: How do nurses define their professional, personal, and private roles? What are nurses’ experiences with professional boundaries? What are the implications of nurses’ understanding of these boundaries? Background: Nurse–patient relationships are characterized by asymmetrical power dynamics, which places the responsibility of delineating professional (...) boundaries on the nurse. While ethical codes offer guidance, nurses must identify appropriate boundaries in a dynamic process that relies on the clinical context. Research design: This study used critical discursive psychological analysis to examine data from participant observations, individual interviews, and focus group discussions. Participants and research context: We included 16 nurses working in mental health care in this study, comprising 12 in specialist mental health care and 4 in community mental health care. Ethical considerations: The study was registered with Norwegian Social Science Data Services. Results: Nurses defined professionalism as being an educated caregiver who prioritizes patients’ needs. Professionalism involves personal engagement, while some personal matters remain private. However, nurses experienced challenges in maintaining professional boundaries, facing dilemmas due to the subjective nature of boundaries and patients’ unpredictable responses. Conclusions: While nurses prioritize patients’ needs and best interests, this study demonstrated that personal engagement is considered part of professionalism. However, nurses encounter complex dilemmas in setting professional boundaries. Additionally, these boundaries can either emphasize or de-emphasize the power differential in nurse-patient relationships. (shrink)

BackgroundInstitutions, funding agencies and publishers are placing increasing emphasis on good research data management (RDM). RDM lapses in medical science can result in questionable data and cause the public’s confidence in the scientific community to crumble. A fledgling medical school in a young university in Singapore has mandated every funded research project to have a data management plan (DMP). However, researchers’ adherence to their DMPs was unknown until the school embarked on routine data auditing. (...) We hypothesize that research data auditing improves RDM awareness, compliance and reception in the school.MethodsWe conducted surveys with research PIs and researchers before and after data auditing to evaluate differences in self-reported RDM awareness, compliance and reception. As it is mandatory to deposit research data in a central data repository system in the school, we tracked data deposition by each laboratory from 2 weeks before to 3 months after data auditing as a marker of actual RDM compliance.ResultsResearch data auditing had an overall positive effect on self-reported RDM awareness, compliance and reception for both research PIs and researchers. Research PIs agreed more that RDM was important to scientific reproducibility, were more aware of proper RDM, had higher RDM strength in their laboratories and were more compliant with the DMP. Both research PIs and researchers believed data auditing helped them to be more compliant with data deposition in the repository. However, data auditing had no significant impact on laboratories’ data deposition rates over time, which could be due to the short sampling period.ConclusionsResearch PIs and researchers generally felt that data auditing was effective in improving RDM practices. It helped to evaluate their RDM practices objectively, propose corrective actions for RDM lapses and spread awareness of the university’s data management policies. Our findings corroborated other studies in medical research, geosciences, engineering and ethics that data auditing promotes good RDM practices. Hence, we recommend research institutions worldwide to adopt data auditing as a tool to reinforce research integrity. (shrink)

Objectives: The aim of this paper is to examine the way in which nurses manage patients who refuse nursing care procedures.Design: This paper reports on a qualitative study which was undertaken to explore the way in which nurses obtain consent prior to nursing care procedures. Focus groups were carried out to obtain background data concerning how consent is obtained. Critical incidents were collected through in depth interviews as a means of focusing on specific incidents in clinical practice.Setting: Two teaching (...) hospitals in England.Participants: Purposive sample of qualified nurses.Results: When a patient refuses nursing care, nurses respond by giving information until the patient finally accedes to the procedure. Nurses will go to great lengths to achieve patients’ agreement to the procedure, but the extent to which the agreement remains voluntary cannot be ascertained by the data collected in this study. If the patient does not eventually agree to a procedure, there is evidence that nurses will administer the care in the absence of consent.Conclusions: Nurses are concerned to obtain the patient’s consent prior to the administration of nursing care but if this cannot be achieved do not regard obtaining consent as an absolute requirement. Consent is preferred, but not considered essential. Nurses have some understanding of the principles of informed consent but do not apply them to everyday clinical nursing practice. (shrink)

Background Equitable care is a fundamental value in the nursing profession. Healthcare workers have both a moral and professional duty to ensure that they do not discriminate. Aim This study aimed to explore how patients perceive equitable nursing care. Research design, participants, and research context This descriptive phenomenological qualitative research study used purposeful sampling to select 17 patients from various departments of a general hospital in southern Iran. The participants were then interviewed using a semi-structured in-depth interview format, which aimed (...) to delve into their experiences with equitable nursing care. The collected data were analyzed using Colaizzi's seven-step method and MAXQDA20 software. Ethical considerations Oral and written information about the study was provided before the participants gave their written consent. The transcribed interviews were de-identified. The study was approved by the Ethics Committee of Jiroft University of Medical Sciences. Findings The data analysis of the study identified three main themes and six subthemes that were related to the experiences of patients with equitable nursing care. The first theme, equitable care, encompassed subthemes such as nurses’ dedicated efforts to facilitate patient recovery and adherence to ethical behavior. The second theme, unconscious causes of inequitable nursing care, included subthemes such as unintentional discrimination stemming from organizational constraints and unconscious biases resulting from a lack of knowledge and skills. The third theme, discriminatory care, comprised subthemes such as deliberate discrimination based on personal traits and selective discrimination. Conclusion The study findings indicate that achieving equitable nursing care requires a multifaceted approach. This includes effective hospital management, organizational reforms, and regulatory enhancements. Additionally, it is crucial to pay close attention to the needs of patients, enhance nurses’ theoretical and practical skills in providing equitable care, fostering a culture of equality within healthcare settings, and consider the personality dimensions and moral characteristics of nurses. (shrink)

Background: I suggest this individualized care is a fundamental principle closely linked to nursing ethics and has important benefits for the patients, however, nurses do not always take into consideration the principles of individualized care. Moreover, there is no validated instrument to assess patients’ views of individualized care in Spanish-speaking countries. Objectives: To assess the validity and reliability of the Spanish version of the Individualized Care Scale-patient. Design: A cross-sectional study design was conducted. A questionnaire survey, including the Individualized (...) Care Scale-patient, was used for data collection. Psychometric properties of reliability and validity were assessed. Fit indices of the overall model were computed. Participants and research context: Survey data were collected from a sample of 118 inpatients at a public hospital in Spain. Ethical considerations: Informed consent from participants and ethical approval was obtained from a regional Clinical Research Ethics Committee. Findings: Ordinal Cronbach’s alphas were 0.966 for Individualized Care Scale-patient subscale A and 0.969 for Individualized Care Scale-patient subscale B. The polychoric correlation between each item and the subscale ranged between 0.653–0.874 and 0.604–0.916, respectively. The exploratory factor analysis revealed a three-factor solution. Personal life situation explained relatively large amounts of the variance. Goodness of fit index showed a good fit for the model. Discussion: This study confirms three factors underlining the individualized care concept, but some differences were found in the load of the factors, such as the relevance of “personal life situation” subscale, that need further research. Conclusion: The Spanish version of the Individualized Care Scale-patient is reliable, valid, user-friendly, and suitable to be used in Spanish-speaking countries showing satisfactory properties. This instrument may help managers better understand and develop areas in which patients perceive lower individualized care received and the factors influencing it. Such key information will help ensure the right of the patient to be respected as an individual. (shrink)

Background: There is little research comparing clinicians’ and managers’ views on priority settings in the healthcare services. During research on two different qualitative research projects on healthcare prioritisations, we found a striking difference on how hospital executive managers and clinical healthcare professionals talked about and understood prioritisations. Aim: The purpose of this study is to explore how healthcare professionals in mental healthcare and somatic medicine prioritise their care, to compare different ways of setting priorities among managers and clinicians and to (...) explore how moral dilemmas are balanced and reconciled. Research design and participants: We conducted qualitative observations, interviews and focus groups with medical doctors, nurses and other clinical members of the interdisciplinary team in both somatic medical and mental health wards in hospitals in Norway. The interviews were recorded and transcribed verbatim. Ethical considerations: Basic ethical principles for research ethics were followed. The respondents signed an informed consent for participation. They were assured anonymity and confidentiality. The studies were approved by relevant ethics committees in line with the Helsinki Convention. Findings: Our findings showed a widening gap between the views of clinicians on one hand and managers on the other. Clinicians experienced a threat to their autonomy, to their professional ideals and to their desire to perform their job in a professional way. Prioritisations were a cause of constant concern and problematic decisions. Even though several managers understood and empathised with the clinicians, the ideals of patient flow and keeping budgets balanced were perceived as more important. Discussion: We discuss our findings in light of the moral challenges of patient-centred individual healthcare versus demands of distributive justice from healthcare management. Conclusion: The clinicians’ ideals of autonomy and good medical and nursing care for the individual patients were perceived as endangered. (shrink)

Background The growing number of older people worldwide poses challenges for health policy, particularly in the Global North, where policymakers increasingly expect seniors to live and receive care at home. However, healthcare professionals, particularly in home-based care, face dilemmas between adhering to care ideals and meeting external demands. Although they strive to uphold ethical care standards, they must deal with patients’ needs, cooperation with colleagues and management guidelines. Home-based care is an essential part of healthcare services in Norway, but (...) staff struggle with high patient numbers and time management. This article focuses on how staff deal with ethical challenges related to contextual and organisational constraints. Methods An ethnographic fieldwork in three municipalities in South-East Norway. The first author conducted three to four months of participant observation in each municipality. In addition, she conducted in-depth interviews with key informants in two municipalities and a focus group interview with seven home-based care workers in one municipality. The data was analysed by using a reflexive thematic analysis. Results Staff in home-based care are frequently more loyal to the patient than to the system and to their own needs. To provide good care, all informants disregarded the patient’s formal decision, i.e. they provided more care than the formalised decision stipulated. To prioritise beneficence to patients, informants also disregarded some of the rules applicable in home-based care. In addition, staff accepted risks to their own safety and health to provide care in the patient’s home. Conclusion The loyalty of home-based care staff to their patients can go beyond their loyalty to the rules of the system and even their own safety. This commitment might be attributed to a sense of doing meaningful work, to providing relationship-based and individualised care, and to strong moral courage. However, the staff’s emphasis on flexibility and individualised care also brings challenges related to unclear boundaries related to patient care. (shrink)

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies (...) accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

There is limited knowledge about cancer patients' experiences of uncertainty while waiting for genome sequencing results, and whether prolonged uncertainty contributes to psychological factors in this context. To investigate uncertainty in patients with a cancer of likely hereditary origin while waiting for genome sequencing results, we collected questionnaire and interview data at baseline, and at three and 12 months follow up. Participants had negative attitudes towards uncertainty at baseline, and low levels of uncertainty at three and 12 months. Uncertainty (...) about genome sequencing did not change significantly over time [t = 0.660, p = 0.510]. Greater perceived susceptibility for cancer [r = 0.14, p < 0.01], fear of cancer recurrence [r = 0.19, p < 0.01], perceived importance of genome sequencing [r = 0.24, p < 0.01], intention to change behavior if a gene variant indicating risk is found [r = 0.29, p < 0.01], perceived ability to cope with results [r = 0.36, p < 0.01], and satisfaction with decision to have genome sequencing [r = 0.52, p < 0.01] were significantly correlated with negative attitudes towards uncertainty at baseline. Multiple primary cancer diagnoses [B = −2.364 [−4.238, −0.491], p = 0.014], lower perceived ability to cope with results [B = −0.1.881 [−3.403, −0.359], p = 0.016] at baseline, greater anxiety about genome sequencing [B = 0.347 [0.148, 0.546], p = 0.0012] at 3 months, and greater perceived uncertainty about genome sequencing [B = 0.494 [0.267, 0.721] p = 0.000] at 3 months significantly predicted greater perceived uncertainty about genome sequencing at 12 months. Greater perceived uncertainty about genome sequencing at 3 months significantly predicted greater anxiety about genome sequencing at 12 months [B = 0.291 [0.072, 0.509], p = 0.009]. Semi-structured interviews revealed that while participants were motivated to pursue genome sequencing as a strategy to reduce their illness and risk uncertainty, genome sequencing generated additional practical, scientific and personal uncertainties. Some uncertainties were consistently discussed over the 12 months, while others emerged over time. Similarly, some uncertainty coping strategies were consistent over time, while others emerged while patients waited for their genome sequencing results. This study demonstrates the complexity of uncertainty generated by genome sequencing for cancer patients and provides further support for the inter-relationship between uncertainty and anxiety. Helping patients manage their uncertainty may ameliorate psychological morbidity. (shrink)