Re-focusing the ethical discourse on personalized medicine: a qualitative interview study with stakeholders in the German healthcare system

Background: In recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM's further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. on what - empirical and normative - assumptions ethical arguments are based regarding PM's current and future developments. Methods: To gather this information, we conducted a qualitative interview study with stakeholders in the German health care system. Our purposive sample included 17 representatives of basic research, clinical research, health economics, regulatory authorities, reimbursement institutions, pharmaceutical industry, patient organizations, as well as clinicians and legal experts involved in PM developments or policy making. We used an interview guide with open-ended questions and analyzed transcriptions of the interviews by means of qualitative content analysis. Results: The respondents addressed a multitude of concerns in the context of research on as well as application of personalized preventive and therapeutic measures both on the individual and on the societal level. Interestingly, regarding future developments of PM the ethical evaluation seemed to follow the rule: the less likely its application, the more problematic a PM measure is assessed. The more likely its application, on the other hand, the less problematic it is evaluated. Conclusions: The results of our study suggest re-focusing the ethical discourse on PM in Germany towards a constructive ethical monitoring which ensures to include only, nevertheless all of the actual and/or potential concerns that are ethically relevant in order to allow balancing them against the actual and potential ethically relevant benefits of PM measures. To render this possible, we propose a strategy for evaluating ethical concerns in the context of PM

Ethische Fragen von Digital Public Health

Digitale Technologien in Public Health bieten durch die effiziente Erfassung, Speicherung und Verarbeitung großer Mengen an Gesundheitsdaten ein Potenzial für eine verbesserte Gesundheitsförderung und Krankheitsprävention. Digital Public Health wirft – wie viele andere technologische Entwicklungen – aber auch verschiedene ethische Fragen auf, die im vorliegenden Beitrag vorgestellt werden. Eine grundlegende Frage bei der ethischen Bewertung einer Digital-Public-Health-Intervention ist die nach ihrem eigentlichen Ziel. Primär sollte eine Intervention der öffentlichen Gesundheit dienen und nicht dem finanziellen Gewinn, um ein Nutzenpotenzial für die Gesundheit der Bevölkerung entwickeln zu können. Zudem sind insbesondere gerechtigkeitsethische Fragen relevant, da Digital Public Health einerseits gesundheitliche Ungleichheiten reduzieren, sie aber andererseits auch verstärken kann. Hinzu kommen Fragen des Schutzes der Privatsphäre und sensibler Gesundheitsdaten. Da sich Digital-Public-Health-Interventionen ganz erheblich unterscheiden, muss jede Anwendung für sich hinsichtlich ihrer ethischen Implikationen bewertet werden. Hierfür werden eine ethische Kriteriologie und ein methodisches Vorgehen vorgeschlagen. Durch die Formulierung ethisch begründeter Empfehlungen für die Entwicklung und Nutzung von digitalen Public-Health-Interventionen kann ein Beitrag zu einer ethisch gut begründeten Gestaltung von Digital Public Health geleistet werden.Digital technologies in public health have the potential to improve health promotion and disease prevention by the efficient registration, storage, and processing of large amounts of health data. Digital public health also raises – like other technological developments – several ethical issues, which are discussed in this article. A fundamental question in the ethical evaluation of digital public health interventions concerns the goal of the intervention: An intervention should serve the established goals of public health and not financial interests, to realize potential health benefits for the population. In addition, equity issues are especially relevant, because digital public health may reduce or increase health inequalities in the population. Furthermore, the protection of privacy and potentially sensitive health data are relevant. As digital public health applications vary considerably, each application has to be assessed individually regarding its ethical implications. This article therefore presents a normative framework and a methodological approach for the ethical evaluation of digital public health applications. By developing ethically justified recommendations for the design and use of digital public health applications, the ethical evaluation can contribute to an ethically justified practice of digital public health

Evaluating a patient's request for life-prolonging treatment: an ethical framework

Contrary to the widespread concern about over-treatment at the end of life, today, patient preferences for palliative care at the end of life are frequently respected. However, ethically challenging situations in the current healthcare climate are, instead, situations in which a competent patient requests active treatment with the goal of life-prolongation while the physician suggests best supportive care only. The argument of futility has often been used to justify unilateral decisions made by physicians to withhold or withdraw life-sustaining treatment. However, we argue that neither the concept of futility nor that of patient autonomy alone is apt for resolving situations in which physicians are confronted with patients' requests for active treatment. Instead, we integrate the relevant arguments that have been put forward in the academic discussion about 'futile' treatment into an ethical algorithm with five guiding questions: (1) Is there a chance that medical intervention will be effective in achieving the patient's treatment goal? (2) How does the physician evaluate the expected benefit and the potential harm of the treatment? (3) Does the patient understand his or her medical situation? (4) Does the patient prefer receiving treatment after evaluating the benefit-harm ratio and the costs? (5) Does the treatment require many resources? This algorithm shall facilitate approaching patients' requests for treatments deemed futile by the physician in a systematic way, and responding to these requests in an ethically appropriate manner. It thereby adds substantive considerations to the current procedural approaches of conflict resolution in order to improve decision making among physicians, patients and families

Transformative medical ethics: a framework for changing practice according to normative–ethical requirements

We propose a step-by-step methodological framework of translational bioethics that aims at changing medical practice according to normative–ethical requirements, which we will thus call “transformative medical ethics.” The framework becomes especially important when there is a gap between widely acknowledged, ethically justified normative claims and their realization in the practice of biomedicine and technology (ought–is gap). Building on prior work on translational bioethics, the framework maps a process with six different phases and 12 distinct translational steps. The steps involve various research activities including conceptual philosophical inquiry and (socio-)empirical research. On the one hand, the framework can be used as a heuristic tool to identify barriers to the transformation process. On the other hand, it can provide guidance for researchers and practitioners to develop appropriate (conceptual action and practice) models, which are then implemented and evaluated in specific practice contexts. We use the example of realizing the norm of respect for autonomy in the practice of medical decision-making to illustrate the framework. Further research is required, for example, to theoretically underpin the framework, to apply it to other ought–is gaps, and to evaluate its feasibility and effectiveness in various practice areas. Overall, the framework of transformative medical ethics suggests a strategic process to investigate and promote practice change that is ethically informed in all phases

Does facilitated Advance Care Planning reduce the costs of care near the end of life? Systematic review and ethical considerations

Background: While there is increasing evidence that Advance Care Planning has the potential to strengthen patient autonomy and improve quality of care near the end of life, it remains unclear whether it could also reduce net costs of care. Aim: This study aims to describe the cost implications of Advance Care Planning programmes and discusses ethical conflicts arising in this context. Design: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data sources: We systematically searched the databases PubMed, NHS EED, EURONHEED, Cochrane Library and EconLit. We included empirical studies (no limitation to study type) that investigated the cost implications of Advance Care Planning programmes involving professionally facilitated end-of-life discussions. Results and discussion: Seven studies met our inclusion criteria. Four of them used a randomised controlled design, one used a before-after design and two were observational studies. Six studies found reductions in costs of care ranging from USD1041 to USD64,827 per patient, depending on the study period and the cost measurement. One study detected no differences in costs. Studies varied considerably regarding the Advance Care Planning intervention, patient selection and costs measured which may explain some of the variations in findings. Normative appraisal: Looking at the impact of Advance Care Planning on costs raises delicate ethical issues. Given the increasing pressure to reduce expenditures, there may be concerns that cost considerations could unduly influence the sensitive communication process, thus jeopardising patient autonomy. Safeguards are proposed to reduce these risks. Conclusion: The limited data indicate net cost savings may be realised with Advance Care Planning. Methodologically robust trials with clearly defined Advance Care Planning interventions are needed to make the costs and returns of Advance Care Planning transparent

What does it take to consent to islet cell xenotransplantation?

BACKGROUND The transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent process for xenotransplantation. METHODS We conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis. RESULTS In the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants' questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations. CONCLUSIONS To become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic

Principle-based structured case discussions: do they foster moral competence in medical students?

BACKGROUND: Recent findings suggest that medical students' moral competence decreases throughout medical school. This pilot study gives preliminary insights into the effects of two educational interventions in ethics classes on moral competence among medical students in Munich, Germany. METHODS: Between 2012 and 2013, medical students were tested using Lind's Moral Competence Test (MCT) prior to and after completing different ethics classes. The experimental group (EG, N = 76) participated in principle-based structured case discussions (PBSCDs) and was compared with a control group with theory-based case discussions (TBCDs) (CG, N = 55). The pre/post C-scores were compared using a Wilcoxon Test, ANOVA and effect-size calculation. RESULTS: The C-score improved by around 3.2 C-points in the EG, and by 0.2 C-points in the CG. The mean C-score difference was not statistically significant for the EG (P = 0.14) or between the two groups (P = 0.34). There was no statistical significance for the teachers' influence (P = 0.54) on C-score. In both groups, students with below-average (M = 29.1) C-scores improved and students with above-average C-scores regressed. The increase of the C-Index was greater in the EG than in the CG. The absolute effect-size of the EG compared with the CG was 3.0 C-points, indicating a relevant effect. CONCLUSION: Teaching ethics with PBSCDs did not provide a statistically significant influence on students' moral competence, compared with TBCDs. Yet, the effect size suggests that PBSCDs may improve moral competence among medical students more effectively. Further research with larger and completely randomized samples is needed to gain definite explanations for the results

Principle-based structured case discussions: do they foster moral competence in medical students?

BACKGROUND: Recent findings suggest that medical students' moral competence decreases throughout medical school. This pilot study gives preliminary insights into the effects of two educational interventions in ethics classes on moral competence among medical students in Munich, Germany. METHODS: Between 2012 and 2013, medical students were tested using Lind's Moral Competence Test (MCT) prior to and after completing different ethics classes. The experimental group (EG, N = 76) participated in principle-based structured case discussions (PBSCDs) and was compared with a control group with theory-based case discussions (TBCDs) (CG, N = 55). The pre/post C-scores were compared using a Wilcoxon Test, ANOVA and effect-size calculation. RESULTS: The C-score improved by around 3.2 C-points in the EG, and by 0.2 C-points in the CG. The mean C-score difference was not statistically significant for the EG (P = 0.14) or between the two groups (P = 0.34). There was no statistical significance for the teachers' influence (P = 0.54) on C-score. In both groups, students with below-average (M = 29.1) C-scores improved and students with above-average C-scores regressed. The increase of the C-Index was greater in the EG than in the CG. The absolute effect-size of the EG compared with the CG was 3.0 C-points, indicating a relevant effect. CONCLUSION: Teaching ethics with PBSCDs did not provide a statistically significant influence on students' moral competence, compared with TBCDs. Yet, the effect size suggests that PBSCDs may improve moral competence among medical students more effectively. Further research with larger and completely randomized samples is needed to gain definite explanations for the results

Medical professionalism of foreign-born and foreign-trained physicians under close scrutiny: A qualitative study with stakeholders in Germany

Hospitals in Germany employ increasing numbers of foreign-born and foreign-trained (FB&FT) physicians. Studies have investigated how FB&FT physicians experience their professional integration into the German healthcare system, however, the perspectives of stakeholders working with and shaping the work experiences of FB&FT physicians in German hospitals have so far been neglected. This study explores relevant stakeholders' opinions and attitudes towards FB&FT physicians-which likely influence how these physicians settle in-and how these opinions were formed. We conducted a qualitative interview study with 25 stakeholders working in hospitals or in health policy development. The interviews were analyzed within a constructivist research paradigm using methods derived from Grounded Theory (situational analysis as well as open, axial and selective coding). We found that stakeholders tended to focus on problems in FB&FT physicians' work performance. Participants criticized FB&FT physicians' work for deviating from presumably shared professional standards (skill or knowledge and behavioral standards). The professional standards invoked to justify problem-focused statements comprised the definition of an ideal behavior, attitude or ability and a tolerance range that was adapted in a dynamic process. Behavior falling outside the tolerance range was criticized as unacceptable, requiring action to prevent similar deviations in the future. Furthermore, we derived three strategies (minimization, homogenization and quality management) proposed by participants to manage deviations from assumed professional standards by FB&FT physicians. We critically reflect on the social processes of evaluation and problematization and question the legitimacy of professional standards invoked. We also discuss discriminatory tendencies visible in evaluative statements of some participants as well as in some of the strategies proposed. We suggest it will be key to develop and implement better support strategies for FB&FT physicians while also addressing problematic attitudes within the receiving system to further professional integration