The Ethics of Electronic Tracking Devices in Dementia Care: An Interview Study with Developers.

Wandering is a symptom of dementia that can have devastating consequences on the lives of persons living with dementia and their families and caregivers. Increasingly, caregivers are turning towards electronic tracking devices to help manage wandering. Ethical questions have been raised regarding these location-based technologies and although qualitative research has been conducted to gain better insight into various stakeholders' views on the topic, developers of these technologies have been largely excluded. No qualitative research has focused on developers' perceptions of ethics related to electronic tracking devices. To address this, we performed a qualitative semi-structured interview study based on grounded theory. We interviewed 15 developers of electronic tracking devices to better understand how they perceive ethical issues surrounding the design, development, and use of these devices within dementia care. Our results reveal that developers are strongly motivated by moral considerations and believe that including stakeholders throughout the development process is critical for success. Developers felt a strong sense of moral obligation towards topics within their control and a weaker sense of moral obligation towards topics outside their control. This leads to a perceived moral boundary between development and use, where some moral responsibility is shifted to end-users.

Electronic Tracking Devices for People With Dementia: Content Analysis of Company Websites.

BACKGROUND: Electronic tracking devices, also known as locators, monitors, or surveillance devices, are increasingly being used to manage dementia-related wandering and, subsequently, raising various ethical questions. Despite the known importance technology design has on the ethics of technologies, little research has focused on the companies responsible for the design and development of electronic tracking devices. This paper is the first to perform a qualitative analysis of the ethically related content of the websites of companies that design and develop electronic tracking devices. OBJECTIVE: The aim of this study was to understand how companies that design, develop, and market electronic tracking devices for dementia care frame, through textual marketing content, the vulnerabilities and needs of persons with dementia and caregivers, the way in which electronic tracking devices respond to these vulnerabilities and needs, and the ethical issues and values at stake. METHODS: Electronic tracking device company websites were identified via a Google search, 2 device recommendation lists (Alzheimer's Los Angeles and the Canadian Agency for Drugs and Technologies in Health), and the 2 recent reviews of wander management technology by Neubauer et al and Ray et al. To be included, websites must be official representations of companies (not market or third-party websites) developing and selling electronic tracking devices for use in dementia care. The search was conducted on December 22, 2020, returning 199 websites excluding duplicates. Data synthesis and analysis were conducted on the textual content of the included websites using a modified form of the Qualitative Analysis Guide of Leuven. RESULTS: In total, 29 websites met the inclusion criteria. Most (15/29, 52%) companies were in the United States. The target audience of the websites was largely caregivers. A range of intertwined vulnerabilities facing persons with dementia and their caregivers were identified, and the companies addressed these via care tools that centered on certain values such as providing information while preserving privacy. Life after device implementation was characterized as a world aspired to that sees increased safety for persons with dementia and peace of mind for caregivers. CONCLUSIONS: The way electronic tracking device content is currently conveyed excludes persons with dementia as a target audience. In presenting their products as a response to vulnerabilities, particular values are linked to design elements. A limitation of the results is the opaque nature of website content origins. How or when values arise in the process of design, development, and marketing is unknown. Therefore, further research should explore the process companies use to identify vulnerabilities, how values are decided upon and integrated into the design of products, and the perceptions of developers regarding the ethics of electronic tracking devices.

How Can We Optimize the Value Assessment and Appraisal of Orphan Drugs for Reimbursement Purposes? A Qualitative Interview Study Across European Countries.

Introduction: The expansion of orphan drug treatment at increasing prices, together with uncertainties regarding their (cost-)effectiveness raises difficulties for decision-makers to assess these drugs for reimbursement. The present qualitative study aims to gain better insight into current value assessment and appraisal frameworks for orphan drugs, and provides guidance for improvement. Methods: 22 European experts from 19 different countries were included in a qualitative survey, followed by in-depth semi-structured interviews. These experts were academics, members of reimbursement agencies or health authorities, or members of regulatory or health/social insurance institutions. Adopting a Grounded Theory approach, transcripts were analysed according to the QUAGOL method, supported by the qualitative data analysis software Nvivo. Results: Although participants indicated several good practices (e.g., the involvement of patients and the presence of structure and consistency), several barriers (e.g., the lack of transparency) lead to questions regarding the efficiency of the overall reimbursement process. In addition, the study identified a number of "contextual" determinants (e.g., bias, perverse effects of the orphan drug legislation, and an inadequate consideration of the opportunity cost), which may undermine the legitimacy of orphan drug reimbursement decisions. Conclusion: The present study provides guidance for decision-makers to improve the efficiency of orphan drug reimbursement. In particular, decision-makers can generate quick wins by limiting the impact of contextual determinants rather than improving the methods included in the HTA. When implemented into a framework that promotes "Accountability for Reasonableness" (A4R), this allows decision-makers to improve the legitimacy of reimbursement decisions concerning future orphan drugs.

Which Framework to Use? A Systematic Review of Ethical Frameworks for the Screening or Evaluation of Health Technology Innovations.

Innovations permeate healthcare settings on an ever-increasing scale. Health technology innovations (HTIs) impact our perceptions and experiences of health, care, disease, etc. Because of the fast pace these HTIs are being introduced in different healthcare settings, there is a growing societal consensus that these HTIs need to be governed by ethical reflection. This paper reports a systematic review of argument-based literature which focused on articles reporting on ethical frameworks to screen or evaluate HTIs. To do this a four step methodology was followed: (1) Literature search conducted in five electronic literature databases; (2) Identification of relevant articles; (3) Development of data-extraction tool to analyze the included articles; (4) Analysis, synthesis of data and reporting of results. Fifty-seven articles were included, each reporting on a specific ethical framework. These ethical frameworks existed out of characteristics which were grouped into five common ones: (1) Motivations for development and use of frameworks; (2) Objectives of using frameworks; (3) Specific characteristics of frameworks (background context, scope, and focus); (4) Ethical approaches and concepts used in the frameworks; (5) Methods to use the frameworks. Although this multiplicity of ethical frameworks shows an increasing importance of ethically analyzing HTIs, it remains unclear what the specific role is of these analyses. An ethics of caution, on which ethical frameworks rely, guides HTIs in their design, development, implementation, without questioning their technological paradigm. An ethics of desirability questions this paradigm, without guiding HTIs. In the end, a place needs to be found in-between, to critically assess HTIs.

Moral distress in medicine: An ethical analysis.

Moral distress is a negative emotional response that occurs when physicians know the morally correct action but are prevented from taking it because of internal or external constraints. Moral distress undermines a physician's ethical integrity, leading to anger, poor job satisfaction, reduced quality of care and burnout. Scarce literature exists on the ethical aspects of moral distress in medicine. We conducted an ethical analysis of moral distress as experienced by physicians and analysed it from the literature using two predominant ethical theories: principlism and care ethics. Finally, we consider the emergence of moral distress in medicine during the COVID-19 pandemic.

How to Value Orphan Drugs? A Review of European Value Assessment Frameworks.

Background: Decision-makers have implemented a variety of value assessment frameworks (VAFs) for orphan drugs in European jurisdictions, which has contributed to variations in access for rare disease patients. This review provides an overview of the strengths and limitations of VAFs for the reimbursement of orphan drugs in Europe, and may serve as a guide for decision-makers. Methods: A narrative literature review was conducted using the databases Pubmed, Scopus and Web of Science. Only publications in English were included. Publications known to the authors were added, as well as conference or research papers, or information published on the website of reimbursement and health technology assessment (HTA) agencies. Additionally, publications were included through snowballing or focused searches. Results: Although a VAF that applies a standard economic evaluation treats both orphan drugs and non-orphan drugs equally, its focus on cost-effectiveness discards the impact of disease rarity on data uncertainty, which influences an accurate estimation of an orphan drug's health benefit in terms of quality-adjusted life-years (QALYs). A VAF that weighs QALYs or applies a variable incremental cost-effectiveness (ICER) threshold, allows the inclusion of value factors beyond the QALY, although their methodologies are flawed. Multi-criteria decision analysis (MCDA) incorporates a flexible set of value factors and involves multiple stakeholders' perspectives. Nevertheless, its successful implementation relies on decision-makers' openness toward transparency and a pragmatic approach, while allowing the flexibility for continuous improvement. Conclusion: The frameworks listed above each have multiple strengths and weaknesses. We advocate that decision-makers apply the concept of accountability for reasonableness (A4R) to justify their choice for a specific VAF for orphan drugs and to strive for maximum transparency concerning the decision-making process. Also, in order to manage uncertainty and feasibility of funding, decision-makers may consider using managed-entry agreements rather than implementing a separate VAF for orphan drugs.

'Can you please hold my hand too, not only my breast?' The experiences of Muslim women from Turkish and Moroccan descent giving birth in maternity wards in Belgium.

OBJECTIVES: To reach nuanced understanding of the perinatal experiences of ethnic minority women from Turkish and Moroccan descent giving birth in maternity wards in Belgium thereby gaining insight into the underlying challenges of providing intercultural care for ethnic minority persons in a hospital setting. METHODS: A qualitative study design was used by conducting In-depth interviews with 24 women from Turkish and Moroccan descent who gave birth during the past three years in maternity wards in Flanders, Belgium. The interviews were analysed using a Grounded Theory Approach. RESULTS: This study shows that the women's care experiences were shaped by the care interactions with their caregivers, more specifically on the attention that was given by the caregivers towards two essential dimensions of the care relationship, viz. Ereignis (attention to what happens) and Erlebnis (attention to how it happens). These two dimensions were interrelated in four different ways, which defined the women's care experiences as being either 'uncaring', 'protocolized', 'embraced' or 'ambiguous'. Moreover, these experiences were fundamentally embedded within the women's cultural context, which has to be understood as a relational process in which an emotional and moral meaning was given to the women's care expectations, interactions and interpretations of care. CONCLUSIONS: The findings reveal that the quality of intercultural care depends on the nature and quality of care interactions between ethnic minority patients and caregivers much more than on the way in which cultural questions and tensions are being handled or dealt with in a practical way. As such, the importance of establishing a meaningful care relationship should be the priority when providing intercultural care. In this, a shift in perspective on 'culture' from being an 'individual culture-in-isolation' towards an understanding of culture as being inter-relational and emerging from within these care relationships is necessary.

Nurses' experiences of working under time pressure in care for older persons.

BACKGROUND: The international health workforce crisis had led to an increasing shortage of nurses, which has substantial implications for the quality of patient care. This shortage potentially results in nurse-perceived time pressure, which can be particularly challenging for nurses who provide care for older persons. OBJECTIVE: This study aimed to show how geriatric nurses experience working under time pressure, perceive its impact on care and deal with time pressure in daily care. RESEARCH DESIGN: A qualitative descriptive interview design was used. PARTICIPANTS AND RESEARCH CONTEXT: Purposive sampling led to the inclusion of 11 nurses from three geriatric nursing wards in two general hospitals in Flanders (Belgium). Data were collected using semi-structured in-depth interviews and analysed using the QUAGOL (Qualitative Analysis Guide of Leuven). ETHICAL CONSIDERATIONS: The study protocol was approved by the Ethics Committee of the University Hospitals Leuven (Ethics committee of the University Hospitals Leuven). FINDINGS: In all interviews, time pressure was described as ubiquitous in the daily care of older persons. A sense of failure in providing care was the common thread in many interviews. Nurses felt compelled to 'reduce' good-quality care to basic care by focusing on the physical and visible aspects of care. Nevertheless, personal experiences with time pressure and strategies to cope with it differed among the interviewees. These variations were related to the working environment and the nurses themselves. They underscored the importance of nurses' perspectives for a good understanding of the phenomenon of time pressure. DISCUSSION AND CONCLUSION: Working under time pressure in the care of older persons leads to various important challenges for nursing ethics. The findings show that providing care that promotes the human dignity of older persons in busy working environments in which care is rationed is an important ethical challenge. As such, our study offers a baseline for further research and discussion on how to support nurses working under time pressure.

What Does Society Value About Cancer Medicines? A Discrete Choice Experiment in the Belgian Population.

BACKGROUND: Debate on pricing and reimbursement of cancer medicines highlights the need to establish the value of cancer medicines. OBJECTIVE: This study aims to elicit the trade-offs in cancer medicine characteristics that the Belgian population is willing to make. METHODS: A discrete choice experiment used six attributes with three levels each, based on literature and focus group discussions. The survey was sent to a random sample of 3500 Belgian citizens. Based on the choice of 961 respondents, individual parameters were estimated with a mixed logit model. RESULTS: Societal value of cancer medicines was positively affected by a higher number of patients eligible for treatment, a high initial life expectancy and quality of life of patients, a high gain in quality of life and life expectancy due to treatment, and a low treatment cost. The value of 1-year gain in life expectancy was independent from the initial life expectancy of the patient. However, the value of one-point gain in quality of life was higher for patients with a low initial quality of life than for patients with a high initial quality of life. CONCLUSIONS: This study has shown that gain in quality of life with cancer medicines is valued higher by Belgian society for patients who have lower initial quality of life before the start of treatment.

'You can give them wings to fly': a qualitative study on values-based leadership in health care.

BACKGROUND: Within contemporary health care, many of the decisions affecting the health and well-being of patients are not being made by the clinicians or health professionals, but by those involved in health care management. Existing literature on organizational ethics provides insight into the various structures, processes and strategies - such as mission statement, ethics committees, ethical rounds … - that exist to create an organizational climate, which fosters ethical practices and decision-making It does not, however, show how health care managers experience their job as being intrinsically ethical in itself. In the present article, we investigate the way in which ethical values are present in the lived experiences and daily practice of health care management. What does it imply to take up a managing position within a health care institution and to try to do this in an ethically inspired way? METHOD: We carried out a qualitative study (Grounded Theory Approach) to explore the essence of values-based leadership in health care. We interviewed 15 people with extensive experience in health care management in the fields of elderly care, hospital care and mental health care in the various regions of Flanders, Belgium. RESULTS: Six predominant themes, presented as metaphors, illustrate the essence of values-based leadership in health care management. These are: (1) values-based health care management as managing a large garden, (2) as learning and using a foreign language, (3) going on a trekking with an ethical compass, (4) embodying integrity and authenticity in a credible encounter with everyone, (5) being a present and trustworthy leader during sun and storm, and (6) contributing to human flourishing by giving people wings to fly. CONCLUSIONS: Notwithstanding the importance of organizing a good ethics infrastructure, values-based leadership in health care entails much more than that. It is about the co-creation of an integrated and comprehensive ethical climate of which community-model thinking and authentic leadership are essential components. As a never-ending process, the six metaphors can help leaders to take substantive proactive steps to shape a fruitful ethical climate within their organization.

"How do ethnic minority patients experience the intercultural care encounter in hospitals? a systematic review of qualitative research".

BACKGROUND: In our globalizing world, caregivers are increasingly being confronted with the challenges of providing intercultural healthcare, trying to find a dignified answer to the vulnerable situation of ethnic minority patients. Until now, international literature lacks insight in the intercultural care process as experienced by the ethnic minority patients themselves. We aim to fill this gap by analysing qualitative literature on the intercultural care encounter in the hospital setting, as experienced by ethnic minority patients. METHODS: A systematic search was conducted for papers published between 2000 and 2015. Analysis and synthesis were guided by the critical interpretive synthesis approach. RESULTS: Fifty one articles were included. Four dimensions emerged, describing the intercultural care encounter as (1) a meeting of two different cultural contexts of care, (2) in a dynamic and circular process of (3) balancing between the two cultural contexts, which is (4) influenced by mediators as concepts of being human, communication, family members and the hospital's organizational culture. CONCLUSIONS: This review provides in-depth insight in the dynamic process of establishing intercultural care relationships in the hospital. We call for a broader perspective towards cultural sensitive care in which patients are cared for in a holistic and dignity-enhancing way.

What Do the Various Principles of Justice Mean Within the Concept of Benefit Sharing?

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice (commutative, distributive, global, procedural, and compensatory) have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research.

Realizing good care within a context of cross-cultural diversity: an ethical guideline for healthcare organizations in Flanders, Belgium.

In our globalizing world, health care professionals and organizations increasingly experience cross-cultural challenges in care relationships, which give rise to ethical questions regarding "the right thing to do" in such situations. For the time being, the international literature lacks examples of elaborated ethical guidelines for cross-cultural healthcare on the organizational level. As such, the ethical responsibility of healthcare organizations in realizing cross-cultural care remains underexposed. This paper aims to fill this gap by offering a case-study that illustrates the bioethical practice on a large-scale organizational level by presenting the ethical guideline developed in the period 2007-2011 by the Ethics Committee of Zorgnet Vlaanderen, a Christian-inspired umbrella organization for over 500 social profit healthcare organizations in Flanders, Belgium. The guideline offers an ethical framework within which fundamental ethical values are being analyzed within the context of cross-cultural care. The case study concludes with implications for healthcare practice on four different levels: (1) the level of the healthcare organization, (2) staff, (3) care receivers, and (4) the level of care supply. The study combines content-based ethics with process-based benchmarks.

A fair share for the orphans: ethical guidelines for a fair distribution of resources within the bounds of the 10-year-old European Orphan Drug Regulation.

For a significant number of patients, there exists no, or only little, interest in developing a treatment for their disease or condition. Especially with regard to rare diseases, the lack of commercial interest in drug development is a burning issue. Several interventions have been made in the regulatory field in order to address the commercial disinterest in these conditions. However, existing regulations mainly focus on the provision of incentives to the sponsors of clinical trials of orphan drugs, and leave unanswered the overarching question about the rightful place of orphan drugs in resource allocation systems. In this article, we analyse the ethical aspects of funding research and development in the field of rare diseases. We then propose an ethical framework that can help health policy makers move forward in the difficult matter of fairly allocating resources for the prevention, diagnosis and treatment of rare diseases.

QUAGOL: a guide for qualitative data analysis.

BACKGROUND: Data analysis is a complex and contested part of the qualitative research process, which has received limited theoretical attention. Researchers are often in need of useful instructions or guidelines on how to analyze the mass of qualitative data, but face the lack of clear guidance for using particular analytic methods. OBJECTIVES: The aim of this paper is to propose and discuss the Qualitative Analysis Guide of Leuven (QUAGOL), a guide that was developed in order to be able to truly capture the rich insights of qualitative interview data. METHOD: The article describes six major problems researchers are often struggling with during the process of qualitative data analysis. Consequently, the QUAGOL is proposed as a guide to facilitate the process of analysis. Challenges emerged and lessons learned from own extensive experiences with qualitative data analysis within the Grounded Theory Approach, as well as from those of other researchers (as described in the literature), were discussed and recommendations were presented. Strengths and pitfalls of the proposed method were discussed in detail. RESULTS: The Qualitative Analysis Guide of Leuven (QUAGOL) offers a comprehensive method to guide the process of qualitative data analysis. The process consists of two parts, each consisting of five stages. The method is systematic but not rigid. It is characterized by iterative processes of digging deeper, constantly moving between the various stages of the process. As such, it aims to stimulate the researcher's intuition and creativity as optimal as possible. CONCLUSION: The QUAGOL guide is a theory and practice-based guide that supports and facilitates the process of analysis of qualitative interview data. Although the method can facilitate the process of analysis, it cannot guarantee automatic quality. The skills of the researcher and the quality of the research team remain the most crucial components of a successful process of analysis. Additionally, the importance of constantly moving between the various stages throughout the research process cannot be overstated.

Emergency department triage: an ethical analysis.

BACKGROUND: Emergency departments across the globe follow a triage system in order to cope with overcrowding. The intention behind triage is to improve the emergency care and to prioritize cases in terms of clinical urgency. DISCUSSION: In emergency department triage, medical care might lead to adverse consequences like delay in providing care, compromise in privacy and confidentiality, poor physician-patient communication, failing to provide the necessary care altogether, or even having to decide whose life to save when not everyone can be saved. These consequences challenge the ethical quality of emergency care. This article provides an ethical analysis of "routine" emergency department triage. The four principles of biomedical ethics - viz. respect for autonomy, beneficence, nonmaleficence and justice provide the starting point and help us to identify the ethical challenges of emergency department triage. However, they do not offer a comprehensive ethical view. To address the ethical issues of emergency department triage from a more comprehensive ethical view, the care ethics perspective offers additional insights. SUMMARY: We integrate the results from the analysis using four principles of biomedical ethics into care ethics perspective on triage and propose an integrated clinically and ethically based framework of emergency department triage planning, as seen from a comprehensive ethics perspective that incorporates both the principles-based and care-oriented approach.

Communication in nursing care for patients requesting euthanasia: a qualitative study.

AIM: To describe the communication during the euthanasia care process for mentally competent, terminally ill patients in general hospitals in Flanders, as seen from the perspective of the nurse. BACKGROUND: International literature shows that nurses are involved in the care process surrounding euthanasia, regardless of the legal status of euthanasia in the country being studied. In particular, research shows that communication is an important part of good euthanasia care. However, the actual way nurses' communication contributes to the quality of the euthanasia care process remains unclear. DESIGN: A Grounded Theory Design was used. METHODOLOGY: Analysis of 18 in-depth, semi-structured interviews with nurses from nine different hospitals in Flanders (Belgium). The interviews took place during a 20-month period in 2005-2006. RESULTS: The euthanasia care process for mentally competent, terminally ill patients in general hospitals in Flanders is a complex and dynamic process, the connecting thread of which is nurses' communication. During this process, nurses perceive that they communicate often and a lot, with various people, in different contexts, in different ways and with various purposes. This communicative process is intensified by the moral and psychological weight of the theme, and its impact on everyone involved, as well as by the relatively short period of time, during which it all takes place. CONCLUSION: This article adds to the growing body of literature on nursing care for patients requesting euthanasia. The findings suggest that for nurses, communication is a key instrument for realising good-quality euthanasia care. RELEVANCE TO CLINICAL PRACTICE: Being the essence of nursing care for patients requesting euthanasia, nurses' communication requires support and guidance on the level of nursing education, professional guidelines and hospital context.

Nursing care for patients requesting euthanasia in general hospitals in Flanders, Belgium.

AIM: This paper is a report of a study exploring nurses' involvement in the care process for mentally competent, terminally ill patients requesting euthanasia in general hospitals in Flanders, Belgium. BACKGROUND: International literature shows that nurses are involved in the care process surrounding euthanasia, regardless of the legal status of euthanasia in the country being studied. However, their actual involvement remains unclear. METHODS: A grounded theory approach was used. Data were collected over a 20-month period in 2005 and 2006, using individual in-depth interviews. The sample included 18 Registered Nurses employed in nine general hospitals geographically spread over the five provinces of Flanders, Belgium. RESULTS: The care process for patients requesting euthanasia is complex and dynamic, consisting of several stages. Major themes characterized nurses' involvement: being on the alert for a euthanasia request; open and active listening; multidisciplinary team cooperation and analysis of the group dynamics; continuously providing maximum palliative care; multi-tasking; organizing and directing the euthanasia; and finally, providing support for the family, colleagues and oneself. CONCLUSION: Nurses make a unique and indispensable contribution to making the euthanasia care process a good care process. This has to do with their specific form of knowledge, expertise and responsibilities, and their willingness to personally, continually and fully care for the patients requesting euthanasia and for their relatives.