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.

Is suffering a sufficient legitimation for UTx?

Uterus transplantation is a relatively new intervention. A woman with absolute uterine factor infertility receives, by a surgical procedure, a transplanted uterus, most often by living donation. The uterus recipient may thus become pregnant and conceive her own child. As with any other medical treatment, UTx requires legitimation. The anticipated benefits must outweigh the risks of the medical intervention. The risks and benefits of UTx are by no means unequivocal and cannot be easily determined. The benefits depend on the final evaluation of the suffering to be alleviated by the intervention. In the following, we will analyze the suffering addressed by UTx and discuss its normative value. First, we point out that (a) suffering is generally considered an important normative criterion in medicine as well as in the context of UTx; (b) we then describe the risks and anticipated benefits of UTx for the three persons directly concerned: the child, the donor, and the recipient; (c) we further analyze the suffering addressed by UTx. The intervention addresses a form of existential suffering. We discuss the common notion that existential suffering should be evaluated from the subjective perspective of the sufferer; (d) afterwards, we argue that in a social practice like medicine, a one-sided evaluation stemming from the sufferer alone is not sufficient; and (e) finally, arguments from a societal perspective lead us to the conclusion that the existential suffering addressed by UTx does not possess a sufficiently strong normative value to legitimize a high-risk, expensive procedure.

[Chronic pain as an existential challenge]. / Chronischer Schmerz als existenzielle Herausforderung.

There is currently an emphasis on the biopsychosocial concept of pain in pain therapy programs. However, the complexity of chronic pain, in particular its importance for those affected by it, can only be insufficiently captured with this concept. This is due to the fact that, to date, one core aspect of the phenomenon chronic pain has only rarely been taken into account: its existential character. Chronic pain can threaten the self-image and the individual's understanding of the world, their wishes and goals in life, and ultimately the entire integrity of those affected. Statements by chronic pain sufferers show that such pain always represents an existential experience and affects the person as a whole. Two aspects make this very clear: the existential despair of the pain on the one hand, as well as questions of meaning and reorientation on the other. Current treatment concepts, however, do not adequately consider the existential character of such challenges. Chronic pain should therefore always be perceived and treated from a holistic perspective. In this context, the aspects of recognizing its uniqueness, helping to express the pain and giving space to the experience are to be given special consideration in order to support chronic pain patients in dealing with their pain.

Chronic pain as a blind spot in the diagnosis of a depressed society. On the implications of the connection between depression and chronic pain for interpretations of contemporary society.

One popular description of current society is that it is a depressed society and medical evidence about depression's prevalence may well make such an estimation plausible. However, such normative-critical assessments surrounding depression have to date usually operated with a one-sided understanding of depression. This understanding widely neglects the various ways depression manifests as well as its comorbidities. This becomes evident at the latest when considering one of depression's most prominent and well-known comorbidities: chronic pain. Against this background, we aim in this article to substantiate our leading claim that the phenomenal interconnection between depression and chronic pain must be acknowledged in the global diagnosis of a depressive society. Thus, we argue here for a complementation of the dominant interpretation of a depressed society. This would support the overcoming of oversimplified images and estimations about depression in current society and further, help to recognize chronic pain properly on the larger scale of assessments that address society as a whole.

Medical technologies, time, and the good life.

Against the backdrop of emerging medical technologies that promise transgression of temporal limits, this paper aims to show the importance that an individual lifetime's finitude and fugacity have for the question of the good life. The paper's first section examines how the passing of an individual's finite lifetime can be experienced negatively, and thus cause "suffering from the passing of time." The second section is based on a sociological analysis within the conceptual framework of individualization and capitalism, which characterizes many modern individualized and consumerist societies and explains how the described problem of time's passage is particularly relevant today. The paper then proceeds to show and discuss how individuals employ various, primarily medical, enhancement-technologies like social egg freezing, anti-aging-medicine and physical- and neuro-enhancement in an attempt to overcome time's passing. Finally, the paper seeks to explain why such attempts fail and, moreover, why it is exactly the awareness of time's passing that can constitute a prerequisite for a good life.

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.

[From why to what for : On the relevance of a philosophical-existentialistic approach in the treatment of patients with chronic pain]. / Vom Warum zum Wozu : Zur Bedeutung einer philosophisch-existenzialistischen Haltung bei der Behandlung von Patienten mit chronischen Schmerzen.

BACKGROUND: People have the need to find explanations for the events that occur in their lives. This is especially true when it comes to experiences that impact a person's entire existence and endanger their self-esteem and sense of identity. Chronic pain is one such experience. The search for the cause behind such pain is primarily motivated by the expectation that once the cause of the pain has been identified, an effective pain-alleviating therapy should ensue. Due to the numerous advances in the last several decades towards understanding the fundamental mechanisms governing the origins and processing as well as the treatment of pain, such expectations towards medicine can frequently be met; however, in many cases the experiences of chronic pain remain difficult to explain and, above all, very difficult to manage. GOAL: In this article the authors aim to show that it is important to avoid fixation on the question of why, especially with people suffering from chronic pain. METHOD: The article starts by describing how an exclusive orientation towards cause-effect-relationship in the medical context can also lead to negative consequences. Through recourse to the central theses of the existentialist philosopher Albert Camus, the meaning of the what for perspective is then discussed. Finally, with the example of a case study, it is illustrated how this change of perspective can result within the framework of a therapeutic treatment. RESULTS: The following changes in perspective are recommended: the search for the past-centered why should make way for the future-oriented quest for the what for of continuing to live a life with chronic pain.

[Chronic pain and society : Sociological analysis of a complex interconnection]. / Chronischer Schmerz und Gesellschaft : Soziologische Analyse einer komplexen Verschränkung.

The current debate about the interconnection between chronic pain and society is economically narrowed. This involves the threat of losing sight of the fact that the interconnection between society and chronic pain is a complex entanglement that goes beyond economic costs. This article addresses the mentioned entanglement by acknowledging the following four levels of society: (1) the social structure, (2) the way of life, with special reference to occupation and its counterpart, leisure time, (3) the (normative) interpretation patterns of chronic pain and (4) the treatment situation. The applied sociological perspective shows that society, and this also includes medicine, is more than a mere addressee of problems. Society has to be considered as an influencing factor with respect to the development and stabilization of chronic pain. The outlined broadening of the perspective should contribute to a better understanding of the societal impact on chronic pain in order to stimulate an improvement in care and possibly a long-term reduction in costs.

Do New Neuroimaging Findings Challenge the Ethical Basis of Advance Directives in Disorders of Consciousness?

Some authors have questioned the moral authority of advance directives (ADs) in cases in which it is not clear if the author of the AD is identical to the person to whom it later applies. This article focuses on the question of whether the latest results of neuroimaging studies have moral significance with regard to the moral authority of ADs in patients with disorders of consciousness (DOCs). Some neuroimaging findings could provide novel insights into the question of whether patients with DOCs exhibit sufficient psychological continuity to be ascribed diachronic personal identity. If those studies were to indicate that psychological continuity is present, they could justify the moral authority of ADs in patients with DOCs. This holds at least if respect for self-determination is considered as the foundation for the moral authority of ADs. The non-identity thesis in DOCs could no longer be applied, in line with clinical and social practice.

[Suicide on Prescription: the Judgment and the Ethics]. / Selbsttötung auf Rezept: eine Begriffsanalyse des Urteils.

On March 2, 2017, the Federal Administrative Court in Leipzig ruled: In extreme emergencies, terminally ill people have the right to acquire suicide medications.The purpose of this article is to examine the criteria used to define an "extreme emergency". The first step is to analyze the verdict. This will show that the term "unbearable suffering" plays a crucial role in defining the "extreme emergency". In a next step, two philosophical conceptions of the suffering are presented and analyzed with regard to their respective effects for their application in practice. Against this background, it is stated that the application of the criterion of suffering in the judgment is problematic. This leads to the conclusion that the judgment does not constitute a valid basis for practical implementation.

Are older people a vulnerable group? Philosophical and bioethical perspectives on ageing and vulnerability.

The elderly are often considered a vulnerable group in public and academic bioethical debates and regulations. In this paper, we examine and challenge this assumption and its ethical implications. We begin by systematically delineating the different concepts of vulnerability commonly used in bioethics, before then examining whether these concepts can be applied to old age. We argue that old age should not, in and of itself, be used as a marker of vulnerability, since ageing is a process that can develop in a variety of different ways and is not always associated with particular experiences of vulnerability. We, therefore, turn to more fundamental phenomenological considerations in order to reconstruct from a first person perspective the intricate interconnections between the experiences of ageing and vulnerability. According to this account, ageing and old age are phenomena in which the basic anthropological vulnerability of human beings can manifest itself in an increased likelihood of harm and exploitation. Thus, we plead for a combined model of vulnerability that helps to avoid problems related to the current concepts of vulnerability. We conclude first that old age as such is not a sufficient criterion for being categorized as vulnerable in applied ethics, and second that reflections on ageing can help to develop a better understanding of the central role of vulnerability in human existence and in applied ethics.

"Suffering" in Palliative Sedation: Conceptual Analysis and Implications for Decision Making in Clinical Practice.

Palliative sedation is an increasingly used and, simultaneously, challenging practice at the end of life. Many controversies associated with this therapy are rooted in implicit differences regarding the understanding of "suffering" as a prerequisite for palliative sedation. The aim of this study is to inform the current debates by a conceptual analysis of two different philosophical accounts of suffering-1) the subjective and holistic concept and 2) the objective and gradual concept-and by a clinical-ethical analysis of the implications of each account for decisions about palliative sedation. We will show that although the subjective and holistic account of suffering fits well with the holistic approach of palliative care, there are considerable challenges to justify limits to requests for palliative sedation. By contrast, the objective and gradual account fits well with the need for an objective basis for clinical decisions in the context of palliative sedation but runs the risk of falling short when considering the individual and subjective experience of suffering at the end of life. We will conclude with a plea for the necessity of further combined conceptual and empirical research to develop a sound and feasible understanding of suffering, which can contribute to consistent decision making about palliative sedation.

Physician-assisted dying: thoughts drawn from Albert Camus' writing.

Physician-assisted dying (assisted suicide and euthanasia) is currently an intensely discussed topic in several countries. Despite differences in legislation and application, countries with end-of-life laws have similar eligibility criteria for assistance in dying: individuals must be in a hopeless situation and experience unbearable suffering. Hopelessness, as a basic aspect of the human condition, is a central topic in Albert Camus' philosophical work The Myth of Sisyphus, which addresses the question of suicide. Suffering in the face of a hopeless situation, and the way doctors approach this suffering, is the topic of his novel The Plague, which describes the story of a city confronted with a plague epidemic. In this paper, I draw philosophical and ethical conclusions about physician-assisted dying based on an analysis of central concepts in the work of Camus-specifically, those treated in The Myth of Sisyphus and The Plague. On the basis of my interpretation of Camus' work, I argue that hopelessness and unbearable suffering are useless as eligibility criteria for physician-assisted dying, given that they do not sufficiently elucidate where the line should be drawn between patients who should to be eligible for assistance and those who should not.

Is egg freezing a good response to socioeconomic and cultural factors that lead women to postpone motherhood?

In western societies, a growing number of women are currently turning to social egg freezing, a technique that makes it possible to freeze oocytes and thus preserve female reproductive possibilities. The current ethical debate has focused on normative aspects concerning the question of whether social egg freezing empowers women's reproductive autonomy. Due to this narrow focus on autonomy, deeper questions concerning the socio-economic conditions and cultural factors that lead women to delay reproduction, to feel pressured by their biological clock, and thus to consider social egg freezing have not yet received sufficient attention and analysis. The aim of this study was to broaden the ethical debate by focusing on whether social egg freezing is a good response to the socioeconomic and cultural constraints that lead women to postpone motherhood, and therefore whether it can be seen as a means of achieving what in virtue ethics is known as a 'good life'. I will argue that while social egg freezing can be seen as a means to empower women to adapt to current socioeconomic constraints, it is not an adequate response to cultural factors, as these cannot be solved by simply extending a woman's fertility.

[Austrian guideline for palliative sedation therapy (long version) : Results of a Delphi process of the Austrian Palliative Society (OPG)]. / Leitlinie zur Palliativen Sedierungstherapie (Langversion) : Ergebnisse eines Delphiprozesses der Österreichischen Palliativgesellschaft (OPG).

BACKGROUND: Palliative sedation therapy (PST) is an important and ethically accepted therapy in the care of selected palliative care patients with otherwise unbearable suffering from refractory distress. PST is increasingly used in end-of-life care. Austria does not have a standardized ethical guideline for this exceptional practice near end of life, but there is evidence that practice varies throughout the country. OBJECTIVE: The Austrian Palliative Society (OPG) nominated a multidisciplinary working group of 16 palliative care experts and ethicists who established the national guideline on the basis of recent review work with the aim to adhere to the Europeans Association of Palliative Care's (EAPC) framework on palliative sedation therapy respecting Austrians legal, structural and cultural background. METHODS: Consensus was achieved by a four-step sequential Delphi process. The Delphi-process was strictly orientated to the recently published EUROIMPACT-sedation-study-checklist and to the AGREE-2-tool. Additionally national stakeholders participated in the reflection of the results. RESULTS: As a result of a rigorous consensus process the long version of the Austrian National Palliative Sedation Guideline contains 112 statements within eleven domains and is supplemented by a philosophers excursus on suffering. CONCLUSIONS: By establishing a national guideline for palliative sedation therapy using the Delphi technique for consensus and stakeholder involvement the Austrian Palliative Society aims to ensure nationwide good practice of palliative sedation therapy. Screening for the practicability and efficacy of this guideline will be a future task.

["Good dying"--definition and current state of research]. / Was ist "gutes Sterben"? Begriffsklärung und Stand der Forschung.

The advances of modern medicine did not only result in prolongation of life expectancy, but also led to a shift from dying at home to dying in public institutions. In western countries most people die at advanced age in medical facilities. Hence, the question regarding the conditions, which should be provided by society and especially medicine, to allow terminally ill people to experience "good dying" is substantial. For this purpose, an examination of patients', family members' and health care providers' understanding of the term " good dying" is required. The present paper aims at shedding light on the term "good dying" and to summarize the current state of research. Therefore, the attributes of "good dying" will be described from the perspectives of patients, family members and health care providers, which are discussed and examined in current medical-sociological research. These attributes can be illustrated on three dimensions: Quality of life at the end of life (e. g. pain relief, mental well-being), quality of dying (e. g. avoiding prolonged dying, autonomy, presence of relatives) and quality of health care at the end of life (e. g. patient-oriented health care, positive communication between health care providers and patients, availability of guidelines). Although the attributes of "good dying" are described in detail in the existing literature, further studies have to clarify the relevance and impact of these attributes as predictors of "good dying".