Acceptability Criteria of Precision Medicine: Lessons From Patients' Experiences With the GUIDE-IBD Trial Regarding the Use of Mobile Health Technology.

Background: Research about mobile health technologies for inflammatory bowel diseases reveals that these devices are mainly used to predict or self-report disease activity. However, in the near future these tools can be used to integrate large data sets into machine learning for the development of personalized treatment algorithms. The impact of these technologies on patients' well-being and daily lives has not yet been investigated. Methods: We conducted 10 qualitative interviews with patients who used the GUIDE-IBD mHealth technology. This is a special smartphone app for patients to record patient-reported outcomes and a wearable to track physical activity, heart rate, and sleep quality. For data analysis, we used interpretative phenomenological analysis. This method is ideally suited for studying people's lived experiences. Results: The analysis of the data revealed 11 themes that were mentioned by at least 3 participants. These themes were: Self-tracking with wearable devices as normality; variable value of the data from the wearable; risk of putting people under pressure; stimulus to reflect on their own well-being and illness; risk of psychological distress; discussion about app data in the medical consultation is very brief or nonexistent; easier to be honest with an app than with a doctor; questionnaires do not always adequately capture the patient's condition; need for support; the possibility to look at the data retrospectively; and annoyed by additional tasks. Conclusions: Patients identified benefits, risks, and potentials for improvement, which should be considered in the further development of the devices and patient-reported outcome scales, and in the implementation of usual care.

Non-invasive prenatal testing (NIPT): is routinization problematic?

BACKGROUND: The introduction and wide application of non-invasive prenatal testing (NIPT) has triggered further evolution of routines in the practice of prenatal diagnosis. 'Routinization' of prenatal diagnosis however has been associated with hampered informed choice and eugenic attitudes or outcomes. It is viewed, at least in some countries, with great suspicion in both bioethics and public discourse. However, it is a heterogeneous phenomenon that needs to be scrutinized in the wider context of social practices of reproductive genetics. In different countries with their different regulatory frameworks, different patterns of routines emerge that have different ethical implications. This paper discusses an ethics of routines informed by the perspectives of organizational sociology and psychology, where a routine is defined as a repetitive, recognizable pattern of interdependent organizational actions that is carried out by multiple performers. We favour a process approach that debunks the view - which gives way to most of the concerns - that routines are always blindly performed. If this is so, routines are therefore not necessarily incompatible with responsible decision-making. Free and informed decision-making can, as we argue, be a key criterion for the ethical evaluation of testing routines. If free and informed decision-making by each pregnant woman is the objective, routines in prenatal testing may not be ethically problematic, but rather are defensible and helpful. We compare recent experiences of NIPT routines in the context of prenatal screening programmes in Germany, Israel and the Netherlands. Notable variation can be observed between these three countries (i) in the levels of routinization around NIPT, (ii) in the scope of routinization, and (iii) in public attitudes toward routinized prenatal testing. CONCLUSION: An ethics of routines in the field of prenatal diagnostics should incorporate and work with the necessary distinctions between levels and forms of routines, in order to develop sound criteria for their evaluation.

Physicians' perspectives on family caregivers' roles in elderly cancer patients' therapies: a qualitative, interview-based study.

PURPOSE: Clinical communication and facilitating informed and sound medical decisions become challenging as patients age and suffer from age-associated impairments. Family caregivers are perceived as essential actors in addressing these challenges. Here, we explore physicians' perspectives on family caregivers' roles and their involvement in consultations and therapy decision-making situations of elderly cancer patients. METHODS: We examined 38 semi-structured interviews with physicians from different specialities (oncologists, non-oncology specialists, and general practitioners) in Germany who treated elderly cancer patients. Data were analyzed using reflexive thematic analysis. RESULTS: We identified five general and distinct perspectives on the involvement of family caregivers in the therapy process. Family caregivers are seen as (1) translators of medical information; (2) providers of support for the patient; (3) providers of information about the patient; (4) stakeholders with relevant points of view regarding the treatment decision; or (5) individuals who have a disruptive influence on the consultation. The interviewed physicians rarely involved family caregivers closely in consultations. CONCLUSIONS: Although physicians frequently attribute supportive roles to family caregivers, they rarely include them in consultations. Previous studies have found that a triadic setting is often better suited to agreeing upon a patient-centered and needs-based treatment decision for older cancer patients. We infer that physicians too rarely recognize the potential importance of family caregivers. Educators should further integrate family caregiver involvement and its implications in general medical education and professional training.

Views on disability and prenatal testing among families with Down syndrome and disability activists: A comparative analysis of interviews from Germany and Israel.

The prenatal genetic testing arena has witnessed great changes over the past decades and has been the focus of extensive discussion of its ethical, legal, and social implications. Germany and Israel were previously known for strongly contrasting regulations and attitudes of both professionals and laypeople towards genetic testing. Based on qualitative analysis of 37 semi-structured interviews, this study compares German and Israeli family members of individuals with Down syndrome and disability activists, thereby examining the interplay between lived experience and cultural scripts and their impact on the formation of personal views toward disability and prenatal testing. We have found that the differences between Germany and Israel remain, despite the emergence of new technologies, and that family members and disability activists reflect the norms of their socio-cultural environments, thereby emphasising the role society plays in shaping the views of those with direct experience of disability.

Clinicians' and Researchers' Views on Precision Medicine in Chronic Inflammation: Practices, Benefits and Challenges.

(1) Background: Due to the high burden of diseases with chronic inflammation as an underlying condition, great expectations are placed in the development of precision medicine (PM). Our research explores the benefits and possible risks of this development from the perspective of clinicians and researchers in the field. We have asked these professionals about the current state of their research and their expectations, concerns, values and attitudes regarding PM. (2) Methods: Following a grounded theory approach, we conducted qualitative interviews with 17 clinicians and researchers. For respondent validation, we discussed the findings with the participants in a validation workshop. (3) Results: Professionals expect multiple benefits from PM in chronic inflammation. They provided their concepts of professionals' and patients' work in the development of PM in chronic inflammatory diseases. Ethical, process-related and economic challenges were raised regarding the lack of integration of data from minority groups, the risk of data misuse and discrimination, the potential risk of no therapy being available for small strata, the lack of professional support and political measures in developing a healthy lifestyle, the problem of difficult access to the inflammation clinic for some populations and the difficulty of financing PM for all. (4) Conclusions: In the further research, development and implementation of PM, these ethical challenges need to be adequately addressed.

Patients' and professionals' views related to ethical issues in precision medicine: a mixed research synthesis.

BACKGROUND: Precision medicine development is driven by the possibilities of next generation sequencing, information technology and artificial intelligence and thus, raises a number of ethical questions. Empirical studies have investigated such issues from the perspectives of health care professionals, researchers and patients. We synthesize the results from these studies in this review. METHODS: We used a systematic strategy to search, screen and assess the literature for eligibility related to our research question. The initial search for empirical studies in five data bases provided 665 different records and we selected 92 of these publications for inclusion in this review. Data were extracted in a spreadsheet and categorized into different topics representing the views on ethical issues in precision medicine. RESULTS: Many patients and professionals expect high benefits from precision medicine and have a positive attitude towards it. However, patients and professionals also perceive some risks. Commonly perceived risks include: lack of evidence for accuracy of tests and efficacy of treatments; limited knowledge of patients, which makes informed consent more difficult; possible unavailability of access to precision medicine for underprivileged people and ethnic minorities; misuse of data by insurance companies and employers, potential of racial stigmatization due to genetic information; unwanted communication of incidental findings; changes in doctor-patient-relationship through focusing on data; and the problem that patients could feel under pressure to optimize their health. CONCLUSIONS: National legislation and guidelines already minimize many risks associated with precision medicine. However, from our perspective some problems require more attention. Should hopes for precision medicine's benefits be fulfilled, then the ethical principle of justice would require an unlimited access to precision medicine for all people. The potential for autonomous patients' decisions must be greatly enhanced by improvements in patient education. Harm from test results must be avoided in any case by the highest possible data security level and communication guidelines. Changes in the doctor-patient relationship and the impact of precision medicine on the quality of life should be further investigated. Additionally, the cost-effectiveness of precision medicine should be further examined, in order to avoid malinvestment.

Should prenatal screening be seen as 'selective reproduction'? Four reasons to reframe the ethical debate.

There are a number of problems with the classification of prenatal screening as a form of 'selective reproduction' that has become an increasingly dominant classification scheme in the last decade. (1) Since the term 'selection' implies choosing one out of several (at least two), it misdescribes the decision to terminate a pregnancy. (2) Deciding whether to have this child is a decision taken within the relationships that constitute the pregnancy. (3) 'Selection' is a loaded term, connecting prenatal diagnosis to negative eugenics or to population genetics. (4) Deciding against the birth of a child who would suffer or would not be able to flourish is a decision taken within a negotiation of personal responsibilities and social constraints. The characterization of prenatal screening as selective reproduction is, in a very narrow way, defensible to reconstruct why prenatal screening is permissible in a liberal state and should not be banned, but it needs to be rejected as a general frame for understanding the substance of the ethical issues around prenatal diagnosis and screening. Ethics should rather attempt to create a respectful space of mutual understandings and reflect how women and couples, who are ultimately responsible for these decisions, perceive their responsibilities in care.

The role of family confidants and caregivers in the care of older cancer patients: Extending the concept of "shared decision-making".

BACKGROUND AND AIMS: Family caregivers play an important role in assisting their family members with cancer, but their influence on the treatment decision-making process has not yet been adequately investigated. This exploratory study approached this topic via reconstructive methodology, focusing on assessing patient-caregiver relationships. METHODS: We conducted semi-structured interviews with 37 mostly elderly cancer patients (median age: 74 years) about the context of their diagnosis, treatment decision, and family support. Additionally, we interviewed 34 caregivers of cancer patients. Of these, 25 were related to patients interviewed. We analyzed the interviews via a multi-step coding method informed by Grounded Theory methodology toward characterizing patient-caregiver relationships, the treatment decision-making process, and the caregivers' role therein. RESULTS: In the majority of cases (86%), patients were being supported by caregivers. We categorized patient-caregiver relationships in regards to the caregivers' involvement in the therapy decision-making process. We found patient-caregiver interaction patterns that indicate the potential of caregivers to decidedly influence the therapy decision-making process. Yet, only in 38% of cases, a caregiver attended relevant patient-physician-consultations. CONCLUSION: Depending on the nature of the patient-caregiver relationship, the traditional concept of shared decision-making, which assumes a dyadic relationship, needs to be extended toward a more dynamic concept in which caregivers should be involved more frequently. This could enable physicians to better understand a patient's reasons for or against a therapy proposal and ensure that the patient's wishes are communicated and considered. On the other hand, strong caregiver-involvement bears risks of over-stepping elderly patients' wishes, thus violating patient autonomy.

[Remaining life expectancy as a criterion of triage? - Contra]. / Restlebenserwartung als Kriterium bei der Triage? ­ Contra.

A common intuition says the death of a younger person is more tragic, since older people could already live through more "innings" of their life. The most important reason against using age as a criterion in triage is however the infinite value of the other: In a relationship of responsibility and care, which is the functional base of medicine also in situations of emergency, the life of each other has infinite value, and therefore cannot be weighed against each other.

Interviewers as Intruders? Ethical Explorations of Joint Family Interviews.

This paper discusses a case vignette that captures an ethically challenging situation in qualitative research. The study was about families who had experienced a life-saving bone marrow transplantation between siblings, who were children at the time of transplantation. A difficult situation emerged during a joint family interview that took place a few years after the transplantation. Parents, donor and the recipient were present, both still children. This interview technique produced unique, rich, and nuanced data about the family dynamics, about how the family constructed relationships and identity ("doing family"). The difficulties included a confrontation of the 10-year old donor child with accusations and pejorative statements from the other family members and his sidelining from the conversation. The interviewers have been acutely aware that their presence in this situation in this moment was an intrusion into family dynamics. In his commentary, Simon Woods emphasizes a model of ethical reflexivity, which shows how reflexive researchers can incorporate moral reflection at the different stages of the research process. Tim Henning argues for a morally engaged interviewer: the researcher should not stay uninvolved and should show willingness to actually engage in a moral discourse with the participants. Since the actual harms were caused not during the interviews but long before, it may be beneficial to bring them out in the open, as a matter for discussion, painful though it may be. The authors of the vignette (Madeleine Herzog, Martina Jürgensen, Christoph Rehmann-Sutter and Christina Schües) respond to the commentaries by endorsing the model of the reflexive researcher while rejecting (for methodological and moral reasons) the model of the morally engaged researcher.

How palliative care patients' feelings of being a burden to others can motivate a wish to die. Moral challenges in clinics and families.

The article explores the underlying reasons for patients' self-perception of being a burden (SPB) in family settings, including its impact on relationships when wishes to die (WTD) are expressed. In a prospective, interview-based study of WTD in patients with advanced cancer and non-cancer disease (organ failure, degenerative neurological disease, and frailty) SPB was an important emerging theme. In a sub-analysis we examined (a) the facets of SPB, (b) correlations between SPB and WTD, and (c) SPB as a relational phenomenon. We analyzed 248 interviews with 62 patients, their family caregivers, and professionals using grounded theory and interpretive phenomenological analysis. SPB appeared as important empathic concern in care situations. Patients expressed many sorts of concerns for others, but also perceived an altered self-understanding that did not meet mutual expectations within relationships. In SPB associated with WTD three constellations were found: (a) WTD to unburden others; (b) patients decided against hastening death to prevent being a further burden to others (in these cases, the SPB counteracted the wish to die); and (c) both wishes for and against dying were sustained by SPB. These patients often felt paralyzed and suffered deeply. Family caregivers felt emotionally touched by SPB and tried to unburden patients by caring and compassion. We concluded that the impact of SPB on a WTD and the various meanings the facets of SPB have in balancing relationships need to be worked out individually. An early palliative and narrative approach is warranted.

Self-perceived burden to others as a moral emotion in wishes to die. A conceptual analysis.

Patients at the end of their life who express a wish to die sometimes explain their wish as the desire not to be a burden to others. This feeling needs to be investigated as an emotion with an intrinsically dialogical structure. Using a phenomenological approach, two key meanings of the feeling of being a burden to others as a reason for a wish to die are identified. First, it is an existential suffering insofar as it contains the perception of a plight so desperate that it can only be relieved by the end of the patient's existence. Second, it is an empathic concern that implies caring about those who bear the burden of caring for the person at the end of their life. It is therefore a moral emotion, encompassing a series of difficulties, including the subjective perception of a stark imbalance between giving and taking, the adequacy of the representation of the caregiver burden in the patient's mind, and the danger of diminishing the worth of one's life out of shame or self-denigration. R. D. Laing's terminology of crossed perspectives in interexperience is used to systematically distinguish the actual caregiver burden, the patient's view of the caregiver burden, the stress for the patient in feeling that s/he is a burden to the caregiver, and the caregiver's view of the patient's stress. The sense of being a burden implies the belief that the caregiver feels burdened, and the fear that this burden could become unbearable.

Wishes to die at the end of life and subjective experience of four different typical dying trajectories. A qualitative interview study.

RESEARCH AIMS: The motivations that lead to wishes to die (WTD) in palliative care patients with cancer are relatively well studied. But little is known about WTD in other pathologies and the relation between subjective understandings of dying trajectories and a WTD. We investigated the WTD of palliative patients in four different dying trajectories: neurological diseases, organ failure, frailty due to age, and cancer. STUDY POPULATION: 62 palliative cancer (n = 30) and non-cancer (n = 32) patients (10 neurological disease; 11 organ failure; 11 frailty), their families and health professionals in different palliative care settings (248 interviews). STUDY DESIGN AND METHODS: Qualitative semi-structured interviews. Data analysis through Interpretive Phenomenological Analysis and Grounded Theory. RESULTS: In addition to personal motivations, we found that people dealing with similar trajectories were often confronted with similar questions and concerns due to similar challenges. For four trajectories we show typical patterns, similarities and differences that should be considered when talking with patients about their WTD. These illness-related considerations do not explain the WTD completely, but give important information on the challenges for particular patient groups that might experience a WTD. In all patient groups, there were clear moments that triggered a WTD: for neurological patients it was experiencing breathlessness, high-dependency care, or when considering tube feeding or respiratory support; for persons with organ failure it was an acute burdensome crisis; for patients with cancer after the initial diagnosis, it was the first relapse or the move into advanced palliative care; for elderly frail persons it was the move into care facilities, or the loss of important relationships or capabilities. The feeling of being a burden to others was reported in all patient groups. INTERPRETATION: WTD can be triggered within disease trajectories by specific conditions and transitional points that affect agency and self-understanding. A better understanding of the concerns and challenges of a particular dying trajectory as well as its characteristic trigger points can facilitate early and comprehensive communication about patients' WTD, and the underlying motivations and protective factors.

Why Human Germline Editing is More Problematic than Selecting Between Embryos: Ethically Considering Intergenerational Relationships.

Do we have a moral obligation to genetically cure embryos rather than selecting between them? Such an obligation would be an ethical argument for human germline gene editing (hGGE) to avoid the inheritance of genetic conditions instead of using pre-implantation genetic diagnosis (PGD). In this article, the intuition that we do have such a moral obligation is critically evaluated. The article first develops a theoretical framework for discussing the ethical questions of hGGE. This framework is based on an exploration of the phenomenology of the germline, from both biological and philosophical points of view. It interprets the germline as an embodied intergenerational relationship that carries meanings for the parents and for the children-to-be. It relates them to previous family generations, and to their own children. Hence, the germline is a phenomenologically much richer concept than just the line of cells that carry the inheritable genetic information. Against this background, selection is compared with editing and a key moral difference is identified: editing is in effect an act of co-constructing the genome, which necessarily assumes a wider range of responsibilities that include those parts that are left unedited. Introducing hGGE into societies would hence significantly affect and change the moral structure of the intergenerational relationships. Selective implantation, on the other hand (in the context of PGD), is based on a moral choice in favour of the embryo which is to be unaffected by a disease or disability that causes suffering, rather than selecting knowingly the affected one. The claim that hGGE is in the best interests of the child-to-be counterfactually assumes the presence of a patient who has an interest in being cured. The embryo (a potential future patient) is, however, brought into existence by the same act that is also the treatment. The future children who would result from treatment by hGGE may rather have an interest in not having been treated by hGGE, since it makes the intergenerational relationships more complicated and burdensome. The question 'Is hGGE justified, or even an obligation?' is answered with a No.