Ethical values supporting the disclosure of incidental and secondary findings in clinical genomic testing: a qualitative study.

BACKGROUND: Incidental findings (IFs) and secondary findings (SFs), being results that are unrelated to the diagnostic question, are the subject of an important debate in the practice of clinical genomic medicine. Arguments for reporting these results or not doing so typically relate to the principles of autonomy, non-maleficence and beneficence. However, these principles frequently conflict and are insufficient by themselves to come to a conclusion. This study investigates empirically how ethical principles are considered when actually reporting IFs or SFs and how value conflicts are weighed. METHODS: A qualitative focus group study has been undertaken, including a multidisciplinary group of professionals from Belgian centres for medical genetics. The data were analysed thematically. RESULTS: All eight Belgian centres participated in this study. Ethical values were frequently referred to for disclosure policies on IFs and SFs. Participants invoked respect for patient autonomy to support the disclosure of IFs and opt-out options for IFs and SFs, non-maleficence for the professional delineation of reportable IFs and opt-out options for IFs and SFs and (the particular scope of) beneficence for the mandatory reporting of actionable IFs, the delineation of reportable IFs and a current decline of actively pursued SFs. Professional assumptions about patients' genetic literacy were an important factor in the weighing of values. CONCLUSIONS: In line with the traditional bioethical discourse, the mandatory reporting of actionable IFs might be interpreted as a "technological, soft paternalism". Restricting patients' choices might be acceptable, but then its motives should be valid and its beneficent outcomes highly plausible. Hence, the presuppositions of technological, soft paternalism - patients' inability to make informed decisions, normative rationality, the efficacy of beneficent outcomes and the delineated spectrum of beneficence - should be approached critically. Moreover, distributive justice should be considered an important value in the delineation of the current scope of the ethical debate on IFs and SFs. This study of guiding values may stimulate the debate on the ethical grounds for a solid policy on IFs and SFs internationally.

The elephant in the room: a postphenomenological view on the electronic health record and its impact on the clinical encounter.

Use of electronic health records (EHR) within clinical encounters is increasingly pervasive. The digital record allows for data storage and sharing to facilitate patient care, billing, research, patient communication and quality-of-care improvement-all at once. However, this multifunctionality is also one of the main reasons care providers struggle with the EHR. These problems have often been described but are rarely approached from a philosophical point of view. We argue that a postphenomenological case study of the EHR could lead to more in-depth insights. We will focus on two concepts-transparency and multistability-and translate them to the specific situation of the EHR. Transparency is closely related to an embodiment relation in which the user becomes less aware of the technology: it fades into the background, becoming a means of experience. A second key concept is that of multistability, referring to how a technology can serve multiple purposes or can have different meanings in different contexts. The EHR in this sense is multistable by design. Future EHR design could incorporate multistable information differently, allowing the provider to focus on patient care when interacting with the EHR. Moreover we argue that the use of the EHR in the daily workflow should become more transparent, while awareness of the computer in the specific context of the patient-provider relationship should increase.

E-health beyond technology: analyzing the paradigm shift that lies beneath.

Information and computer technology has come to play an increasingly important role in medicine, to the extent that e-health has been described as a disruptive innovation or revolution in healthcare. The attention is very much focused on the technology itself, and advances that have been made in genetics and biology. This leads to the question: What is changing in medicine today concerning e-health? To what degree could these changes be characterized as a 'revolution'? We will apply the work of Thomas Kuhn, Larry Laudan, Michel Foucault and other philosophers-which offers an alternative understanding of progress and revolution in medicine to the classic discovery-oriented approach-to our analysis. Nowadays, the long-standing curative or reactive paradigm in medicine is facing a crisis due to an aging population, a significant increase in chronic diseases and the development of more expensive diagnostic tools and therapies. This promotes the evolution towards a new paradigm with an emphasis on preventive medicine. E-health constitutes an essential part of this new paradigm that seeks to solve the challenges presented by an aging population, skyrocketing costs and so forth. Our approach changes the focus from the technology itself toward the underlying paradigm shift in medicine. We will discuss the relevance of this approach by applying it to the surge in digital self-tracking through health apps and wearables: the recognition of the underlying paradigm shift leads to a more comprehensive understanding of self-tracking than a solely discovery-oriented or technology-focused view can provide.

The Strengths and Challenges of Palliative Day-Care Centers: Qualitative Study With the Professionals Involved.

BACKGROUND: Palliative day-care centers are a marginal service within the palliative care landscape. Relevant research on the potential and added value of this service model is lacking, and it may therefore be underappreciated. AIM: To examine how representatives of Belgian palliative day-care centers perceive their strengths and added value, as well as the biggest challenges to their survival. DESIGN: Qualitative study of individual interviews and an overarching focus group. Data collection was performed from December 2014 to April 2015. Inductive coding was used to extract relevant themes from the verbatim transcripts. SETTING/PARTICIPANTS: Participants were professional representatives of all 5 Flemish palliative day-care centers: 7 participants for the individual interviews and 6 participants for the focus group. RESULTS: Five strengths were identified: (1) unique care model, (2) contact with peers in a nonclinical environment, (3) a reliable and competent multiprofessional team, (4) care tailored to the individual, and (5) respite for family caregivers. The most significant challenges were (1) optimizing government funding and (2) achieving sufficiently high occupancy and referral. According to interviewees, this latter challenge was due to the low visibility of the service to professionals and the public, unclear referral criteria, and the psychological threshold for referral among patients and professionals. CONCLUSIONS: Palliative day-care centers strive to provide unique services for patients with advanced illness. However, negotiating adequate funding and raising referral by changing current perceptions are paramount to unlocking their potential. Scientific analysis of cost utility and patient outcomes associated with their use is necessary.

Understanding patient needs without understanding the patient: the need for complementary use of professional interpreters in end-of-life care.

High-quality doctor-patient communication in end-of-life care results in better quality of life for patients. In linguistically and culturally diverse societies, language discordant consultations become daily practice, leading to difficulties in eliciting patient preferences toward end-of-life care. Although family members invariably act as informal interpreters, this may cause some ethical dilemmas. We present a case of a palliative patient whose son acted as an interpreter. This case generated a triple- layered ethical dilemma: (i) how to safeguard patient autonomy against paternalistic interventions by family members, (ii) how to respect the relational context in which patient autonomy can be realized, and (iii) how to respect the ethno-cultural values of the patient and his family. These issues are being discussed and reflected upon within the framework shared decision making involving informal- and professional interpreters. The complementary use of professional interpreters next to family members acting as informal interpreters is recommended.

Victims of disaster: can ethical debriefings be of help to care for their suffering?

Victims of disaster suffer, not only at the very moment of the disaster, but also years after the disaster has taken place, they are still in an emotional journey. While many moral perspectives focus on the moment of the disaster itself, a lot of work is to be done years after the disaster. How do people go through their suffering and how can we take care of them? Research on human suffering after a major catastrophe, using an ethics of care perspective, is scarce. People suffering from disasters are often called to be in distress and their emotional difficulties 'medicalised'. This brings them often into a situation of long term use of medication, and one can wonder if medication is of help to them in the long run. In our paper, we will explore another moral perspective, focusing on the importance of the victims' narrative and their lived experiences. We will use Paul Ricoeur's phenomenological reflections from 'Suffering is not the same as pain' for conceptualizing human suffering and how to apply it to victims of disaster. Ricoeur suggests that suffering is not a quantity that can be measured, but a characteristic that should be studied qualitatively in interpersonal and narrative contexts. Above all, the perspective of care and listening could offer an opportunity to reconcile people from their loss and suffering.

Accessible health care for Roma: a gypsy's tale a qualitative in-depth study of access to health care for Roma in Ghent.

BACKGROUND: In general, vulnerable populations experience more problems in accessing health care. This also applies to the Roma-population. In the City of Ghent, Belgium, a relatively large group of Roma resides more or less permanently. The aim of this study is to explore the barriers this population encounters in their search for care. METHODS: In this qualitative study using in-depth interviews the barriers to health care for the Roma in Ghent are explored. We interviewed 12 Roma and 13 professionals (volunteers, health care providers,...) who had regular contact with the Roma-population in Ghent. For both groups purposive sampling was used to achieve maximal variation regarding gender, age, nationality and legal status. RESULTS: The Roma-population in Ghent encounters various barriers in their search for care. Financial constraints, not being able to reach health care and having problems to get through the complexity of the system are some of the most critical problems. Another important finding is the crucial role of trust between patient and care provider in the care-giving process. CONCLUSION: Roma share several barriers with other minority groups, such as: financial constraints, mobility issues and not knowing the language. However, more distinctive for this group is the lack of trust in care providers and health care in general. As a result, restraint and lack of communication form serious barriers for both patient and provider in their interaction. In order to ensure equitable access for Roma, more emphasis should be on establishing a relationship of mutual respect and understanding.

Surprising pandemic experiences: A confrontation between principle-based and virtue ethics, and a plea for virtue ethics training for medical students and residents. A rudimentary outline of a four-step model.

BACKGROUND: In past years, physicians have, with a certain continuity, reported increasing numbers of burnout, depression and compassion fatigue in their daily practice. These problems were attributed, not only but also, to a loss of public trust and an increase in violent behaviour of patients and family members towards medical professionals in all walks of life. Recently, however, during the breakout of the coronavirus disease 2019 (COVID-19) pandemic in 2020, there were public expressions of appreciation and respect for health care workers that almost universally have been assessed as indications of a re-establishment of public trust in physicians and appreciation for the medical professions' commitments. In other words, shared experiences of what society was in need of: the experience of a 'common good'. Those responses during the COVID-19 pandemic increased positive feelings among practicing physicians, such as commitment, solidarity, competency, and experiences concerning obligations for the common good and a sense of belonging to one and the same community for all. Essentially, these responses of raised self-awareness of commitment and solidarity between (potential) patients and medical personal point towards the social importance and power of these values and virtues. This shared domain in ethical sources of behaviour seems to hold a promise of overcoming gaps between the different spheres of doctors and patients. That promise justifies stressing the relevance of this shared domain of Virtue Ethics in the training of physicians. METHODS: In this article, therefore, we shall make a plea for the relevance of Virtue Ethics before proposing an outline of an educational programme for Virtue Ethics training for medical students and residents. Let us start by very briefly presenting on Aristotelian virtues and its relevance to modern medicine in general, and during the current pandemic in particular. RESULTS: We shall follow up this short presentation by a Virtue Ethics Training Model and the respective settings in which it takes place. This model has four steps as follows: (a) include moral character literacy in the formal curriculum; (b) provide ethics role modelling and informal training in moral character in the healthcare setting by senior staff; (c) create and apply regulatory guidelines regarding virtues and rules; and (d) assess success of training by evaluation of moral character of physicians. CONCLUSION: Applying the four-step model may contribute to strengthening the development of moral character in medical students and residents, and decrease the negative consequences of moral distress, burnout and compassion fatigue in health care personnel. In the future, this model should be empirically studied.

Co-responsibility: a new horizon for today's health care?

In this article, we focus at a key concept of today's healthcare, namely responsibility. Personal responsibility is so important today because it is obvious that the way society is organized, many people are facing a lot of difficulties to live their lives in a responsible way. We explicitly obtain an analysis of responsibility from a view which avoids the binary thinking which is so remarkably present in today's health care discourse. The aim of this pilot study is therefore to open up the horizon of the use of responsibility in today's healthcare. We develop the notion of 'co-responsibility' to understand how individuals, despite the fact they are responsible for their own agency, are always also affected by an ought which contaminates their efforts to fulfill their duties and obligations. We discuss co-responsibility not as conclusion or a magic formula to all problems, but as a new starting point of which we have to explore the opportunities for current and future health care dilemmas.

[Are we preoccupied with our health?] / Zijn we te veel met onze gezondheid bezig?

While some people are too much occupied with their health, others should be more. This double bind makes of the complex issue of medicalisation a question in the strict meaning of the word: we have to ask ourselves why, despite the ongoing the analyses since Ivan Illich, this double sided evolution is still the case in today's society.

Vulnerable patients' attitudes towards sharing medical data and granular control in patient portal systems: an interview study.

BACKGROUND: The collection, storage and exchange of medical information are becoming increasingly complex. More parties are involved in this process, and the data are expected to serve many different purposes beside patient care. This raises several ethical questions regarding privacy, data ownership, security and confidentiality. It is vital to consider patients' moral attitudes and preferences in this digital information exchange. The voice of vulnerable patients is rarely heard in research addressing these questions. This study aims to address this void. METHOD: Fourteen vulnerable patients without prior experience with patient portal systems were interviewed for this study. First, participants were introduced to the portal and given time to read their personal medical data. Afterwards, semi-structured interviews were conducted and analysed thematically to explore participants' first experience with the portal and their views on sharing medical information with care providers and other parties. RESULTS: Data analysis resulted in four themes: barriers to and benefits of portal access, emotional responses to reading medical information, diverging views on sharing information with third parties and balancing granular control and the best possible care. First, participants appreciated access to their health information in the portal despite experiencing obstacles. Second, reading medical information online could evoke emotional responses. Third, patients were generally unaware of the meaning and value of medical data to third parties, resulting in inconsistent views on data sharing. Finally, although patients generally supported granular control, they were willing to give up on their autonomy if that would ensure them to receive the best possible care. CONCLUSIONS: Patient portal design should take into consideration the obstacles that discourage vulnerable patients' access and hamper meaningful use. There is a need for more transparency on secondary use of medical data by third parties. Patients should be better informed about the potential consequences of sharing data with them.

Patients' moral attitudes toward electronic health records: Survey study with vignettes and statements.

Patient access to electronic health records gives rise to ethical questions related to the patient-doctor-computer relationship. Our study aims to examine patients' moral attitudes toward a shared EHR, with a focus on autonomy, information access, and responsibility. A de novo self-administered questionnaire containing three vignettes and 15 statements was distributed among patients in four different settings. A total of 1688 valid questionnaires were collected. Patients' mean age was 51 years, 61% was female, 50% had a higher degree (college or university), and almost 50% suffered from a chronic illness. Respondents were hesitant to hide sensitive information electronically from their care providers. They also strongly believed hiding information could negatively affect the quality of care provided. Participants preferred to be informed about negative test results in a face-to-face conversation, or would have every patient decide individually how they want to receive results. Patients generally had little experience using patient portal systems and expressed a need for more information on EHRs in this survey. They tended to be hesitant to take up control over their medical data in the EHR and deemed patients share a responsibility for the accuracy of information in their record.

A qualitative study among patients with an inherited retinal disease on the meaning of genomic unsolicited findings.

Exome-based testing for genetic diseases can reveal unsolicited findings (UFs), i.e. predispositions for diseases that exceed the diagnostic question. Knowledge of patients' interpretation of possible UFs and of motives for (not) wanting to know UFs is still limited. This lacking knowledge may impede effective counselling that meets patients' needs. Therefore, this article examines the meaning of UFs from a patient perspective. A qualitative study was conducted and an interpretative phenomenological analysis was made of 14 interviews with patients with an inherited retinal disease. Patients assign a complex meaning to UFs, including three main components. The first component focuses on result-specific qualities, i.e. the characteristics of an UF (inclusive of actionability, penetrance, severity and age of onset) and the consequences of disclosure; the second component applies to a patient's lived illness experiences and to the way these contrast with reflections on presymptomatic UFs; the third component addresses a patient's family embedding and its effect on concerns about disease prognosis and genetic information's family relevance. The complex meaning structure of UFs suggests the need for counselling procedures that transcend a strictly clinical approach. Counselling should be personalised and consider patients' lived illness experiences and family context.

Closing schools for SARS-CoV-2: a pragmatic rapid recommendation.

Background: In Belgium, schools closed during the first lockdown in March 2020, with a partial reopening in May. They fully reopened in September. During the summer, infections started to increase in the general population, speeding up in September. Some measures were taken to limit social contacts but those were insufficient to mitigate the exponential rise of infections in October. Children were still receiving all lessons at school at that time and it was questioned whether this position was tenable. We systematically compared the benefits and harms of closing primary and secondary schools and developed a recommendation. Methods: A multidisciplinary panel, including school pupils and teachers, educational experts, clinicians and researchers, produced this recommendation in compliance with the standards for trustworthy rapid guidelines. The recommendation is based on data collected through national surveillance or studies from Belgium, and supported by a rapid literature review. Results: Closing schools during the first lockdown probably resulted in a large learning delay and possibly led to more cases of child abuse. We are uncertain about the effect on the infection rate, hospitalisations, transmission rates, mental health of children, teachers and parents. The panel concluded that the balance of benefits and harms of closing schools clearly shifts against closing schools. Detrimental effects are even worse for vulnerable children. This recommendation is affected by the local virus circulation. Conclusion: The guideline panel issues a strong recommendation against closing schools when the virus circulation is low to moderate, and a weak recommendation against closing schools when the virus circulation is high. It does not apply when the school system cannot function due to lack of teachers, too many children who are at home or a shortage of support services. As the results of international studies are consistent with Belgian study results, this recommendation may also be relevant internationally.

Oughtonomy in healthcare. A deconstructive reading of Kantian autonomy.

For years now, autonomy has been discussed as one of the central values in health care. Understood as self-realization, it is opposed to paternalism which is conceived as an intolerable occurrence of heteronomy. Although different concepts have been developed to nuance this opposition, when it comes to health care discourse, heteronomy is still the enemy of autonomy. In our article, we defend the thesis that autonomy is only achievable as heteronomy. We are not arguing for an expansion of the meaning of autonomy, but are attempting to conduct an analysis which lays bare the 'disrupting' attendance of heteronomy within the principle of autonomy. Autonomy does not begin where heteronomy ends, but can only begin if heteronomy is already involved. To emphasize this, we prefer to elaborate a new concept: 'oughtonomy'. This concept is inspired by Jacques Derrida's distinction between 'difference' and 'differance'. We will develop the concept of oughtonomy from a deconstructive reading of Kant's idea of autonomy, inspired by philosophers such as Jacob Rogozinski, Jean-Luc Nancy and others. In addition to a first exploration of this concept, this article also discusses the possible consequences of oughtonomy for current debates concerning health care. Our quest for a new understanding of autonomy is motivated by the concern that, although the accent on autonomy as self-realization and independence has many advantages, we should also bear in mind the countless disadvantages.

Study protocol of OncoTolk: an observational study on communication problems in language-mediated consultations with migrant oncology patients in Flanders (Belgium).

INTRODUCTION: Effective doctor-patient communication in oncology settings can be challenging due to the complexity of the cancer disease trajectory. The challenges can become greater when doctors and patients do not share a common language and need to rely on language mediators. The aim of this study is to provide evidence-based recommendations for healthcare professionals, patients and language mediators on how to interact with each other during language-mediated consultations in oncology settings. METHODS AND ANALYSIS: A systematic review of the literature on communication problems in monolingual and multilingual oncology settings will be conducted. Thirty language-mediated consultations with Turkish-speaking or Arabic-speaking cancer patients, language mediators and Dutch-speaking oncologists/haematologists will be video-recorded in three urban hospitals in Flanders, Belgium. All participants will be interviewed immediately after the consultation and 2 weeks after it by means of video-stimulated recall. Multimodal interaction analysis will be combined with qualitative content analysis to allow for the identification of communication practices when communication problems occur. ETHICS AND DISSEMINATION: The study has been approved by the following ethics committees: Ghent University Hospital, Antwerp University Hospital, Antwerp Hospitals Network (ZNA). Results will be published via (inter)national peer-reviewed journals and the findings of the study will be communicated using a comprehensive dissemination strategy aimed at healthcare professionals, patients and language mediators.

Primary Care Physicians' Perspectives on the Ethical Impact of the Electronic Medical Record.

OBJECTIVE: The aim of this study is to explore whether specific ethical questions arise with the use of a shared electronic health record (EHR) system, based on the daily experience of primary care physicians (PCPs). METHODS: In this qualitative research project, we conducted 14 in-depth semistructured interviews with PCPs in a tertiary hospital setting. RESULTS: We identified 4 themes: 1) PCPs describe the EHR as a medicine with side effects, for which they provide suggestions for improvements; 2) A shared record raises ethical questions related to autonomy and trust; 3) Although use of the EHR often disturbs rapport with the patient, it can also support the patient-doctor interaction when it becomes an active part of the conversation; 4) A shared EHR may cause health care providers (and their relatives) to avoid seeking help for sensitive issues. DISCUSSION: PCPs fear access to results could cause confusion and anxiety in patients, resulting in tensions between autonomy and beneficence. Improved efficiency and quality of care with a shared EHR relies on doctors trusting each other's input to avoid duplicate tests. However, this might compromise a fundamental skeptical attitude in practicing medicine, and we should be aware of a risk of increased confirmation and anchoring bias. CONCLUSION: The EHR is considered to be a work in progress-EHR design could be improved by examining physicians' coping strategies and implementing their suggestions for improvement. Ethical questions related to autonomy, trust, and the status of records that belong to doctor-patients need to be considered in future research and EHR development.

Criteria for reporting incidental findings in clinical exome sequencing - a focus group study on professional practices and perspectives in Belgian genetic centres.

BACKGROUND: Incidental and secondary findings (IFs and SFs) are subject to ongoing discussion as potential consequences of clinical exome sequencing (ES). International policy documents vary on the reporting of these findings. Discussion points include the practice of unintentionally identified IFs versus deliberately pursued SFs, patient opt-out possibilities and the spectrum of reportable findings. The heterogeneity of advice permits a non-standardised disclosure but research is lacking on actual reporting practices. Therefore, this study assessed national reporting practices for IFs and SFs in clinical ES and the underlying professional perspectives. METHODS: A qualitative focus group study has been undertaken, including professionals from Belgian centres for medical genetics (CMGs). Data were analysed thematically. RESULTS: All Belgian CMGs participated in this study. Data analysis resulted in six main themes, including one regarding the reporting criteria used for IFs. All CMGs currently use ES-based panel testing. They have limited experience with IFs in clinical ES and are cautious about the pursuit of SFs. Two main reporting criteria for IFs were referred to by all CMGs: the clinical significance of the IF (including pathogenicity and medical actionability) and patient-related factors (including the patient's preference to know and patient characteristics). The consensus over the importance of these criteria contrasted with their challenging interpretation and application. Points of concern included IFs' pathogenicity in non-symptomatic persons, IFs concerning variants of uncertain significance, the requirement and definition of medical actionability and patient opt-out possibilities. Finally, reporting decisions were guided by the interaction between the clinical significance of the IF and patient characteristics. This interaction questions the possible disclosure of findings with context-dependent and personal utility, such as IFs concerning a carrier status. To evaluate the IF's final relevance, a professional and case-by-case deliberation was considered essential. CONCLUSIONS: The challenging application of reporting criteria for IFs results in diversified practices and policy perspectives within Belgian CMGs. This echoes international concerns and may have consequences for effective policy recommendations.