Comparative ethical evaluation of epigenome editing and genome editing in medicine: first steps and future directions.

Targeted modifications of the human epigenome, epigenome editing (EE), are around the corner. For EE, techniques similar to genome editing (GE) techniques are used. While in GE the genetic information is changed by directly modifying DNA, intervening in the epigenome requires modifying the configuration of DNA, for example, how it is folded. This does not come with alterations in the base sequence ('genetic code'). To date, there is almost no ethical debate about EE, whereas the discussions about GE are voluminous. Our article introduces EE into bioethics by translating knowledge from science to ethics and by comparing the risks of EE with those of GE. We, first (I), make the case that a broader ethical debate on EE is due, provide scientific background on EE, compile potential use-cases and recap previous debates. We then (II) compare EE and GE and suggest that the severity of risks of novel gene technologies depends on three factors: (i) the choice of an ex vivo versus an in vivo editing approach, (ii) the time of intervention and intervention windows and (iii) the targeted diseases. Moreover, we show why germline EE is not effective and reject the position of strong epigenetic determinism. We conclude that EE is not always ethically preferable to GE in terms of risks, and end with suggestions for next steps in the current ethical debate on EE by briefly introducing ethical challenges of new areas of preventive applications of EE (III).

Patient data for commercial companies? An ethical framework for sharing patients' data with for-profit companies for research.

BACKGROUND: Research using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called 'real-world' health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro). METHODS: We first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro. RESULTS: We conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients' informational rights and their actions need to be compatible with the public's interest in health benefit from ReuseForPro.

Ethics of the fiduciary relationship between patient and physician: the case of informed consent.

This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often-cited assertion that the patient-physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients' decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician's role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients' risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.

Patients' Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer.

BACKGROUND: Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients' willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE: The aim of the study was to learn about patients' attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS: A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. RESULTS: In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). CONCLUSIONS: Although patients' general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

"Often Relatives are the Key [ ]" -Family Involvement in Treatment Decision Making in Patients with Advanced Cancer Near the End of Life.

BACKGROUND: Family communication has been increasingly recognized as an important factor in decision making near the end of life. However, the role of the family in decision making is less studied in oncology settings, where most patients are conscious and able to communicate almost until dying. The aim of this study was to explore oncologists' and nurses' perceptions of family involvement in decision making about forgoing cancer-specific treatment in patients with advanced cancer. MATERIALS AND METHODS: Qualitative semistructured interviews with 22 oncologists and 7 oncology nurses were analyzed according to the grounded theory approach. The results were discussed against the background of the clinical and ethical debate on family role near the end of life. RESULTS: We could identify two approaches shared by both oncologists and nurses toward family involvement. These approaches could be partly explained by different perception and definition of the concept of patients' autonomy: (a) a patient-focused approach in which a patient's independence in decision making was the highest priority for oncologists and (b) a mediator approach with a family focus in which oncologists and nurses assigned an active role to patients' family in decision making and strived for building consensus and resolving conflicts. CONCLUSION: The main challenge was to involve family, increasing their positive influences on the patient and avoiding a negative one. Thereby, the task of both oncologists and oncology nurses is to support a patient's family in understanding of a patient's incurable condition and to identify a patient's preference for therapy. IMPLICATIONS FOR PRACTICE: This study focused on oncologists' and oncology nurses' perceptions of family involvement in decision making about treatment limitation in patients with advanced cancer who are able to communicate in a hospital setting. Oncologists and oncology nurses should be aware of both positive aspects and challenges of family involvement. Positive aspects are patients' emotional support and support in understanding and managing the information regarding treatment decisions. Challenges are diverging family preferences with regard to treatment goals that might become a barrier to advanced care planning, a possible increased psychological burden for the family. Especially challenging is involving the family of a young patient because increased attention, more time investment, and detailed discussions are needed.

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment.

BACKGROUND: The secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used. OBJECTIVE: Since the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap. METHODS: In this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts. RESULTS: We offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example. CONCLUSIONS: In the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.

The patient-level effect of the cost of Cancer care - financial burden in German Cancer patients.

BACKGROUND: Financial toxicity of cancer has so far been discussed primarily in the US health care system and is associated with higher morbidity and mortality. In European health care systems, the socio-economic impact of cancer is poorly understood. This study investigates the financial burden and patient-reported outcomes of neuroendocrine (NET) or colorectal (CRC) cancer patients at a German Comprehensive Cancer Center. METHODS: This prospective cross-sectional study surveyed 247 advanced stage patients (n = 122 NET/n = 125 CRC) at the National Center for Tumor Diseases, in Germany about cancer-related out-of-pocket costs, income loss, distress, and quality of life. Multiple linear regression analysis was performed to demonstrate the effects of economic deterioration on patients' quality of life and distress. RESULTS: 81% (n = 199) of the patients reported out-of-pocket costs, and 37% (n = 92) income loss as a consequence of their disease. While monthly out-of-pocket costs did not exceed 200€ in 77% of affected patients, 24% of those with income losses reported losing more than 1.200€ per month. High financial loss relative to income was significantly associated with patients' reporting a worse quality of life (p < .05) and more distress (p < .05). CONCLUSIONS: Financial toxicity in third-party payer health care systems like Germany is caused rather by income loss than by co-payments. Distress and reduced quality of life due to financial problems seem to amplify the burden that already results from a cancer diagnosis and treatment. If confirmed at a broader scale, there is a need for targeted support measures at the individual and system level.

Do patients and research subjects have a right to receive their genomic raw data? An ethical and legal analysis.

BACKGROUND: As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. METHODS: In a first step we clarify some central concepts such as "raw data"; in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one's raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. RESULTS: In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. CONCLUSION: Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects' legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations.

Digitalizing Health Services by Implementing a Personal Electronic Health Record in Germany: Qualitative Analysis of Fundamental Prerequisites From the Perspective of Selected Experts.

BACKGROUND: The implementation of a personal electronic health record (PHR) is a central objective of digitalization policies in the German health care system. Corresponding legislation was passed with the 2015 Act for Secure Digital Communication and Applications in the Health Sector (eHealth Act). However, compared with other European countries, Germany still lags behind concerning the implementation of a PHR. OBJECTIVE: In order to explore potential barriers and facilitators for the adoption of a PHR in routine health care in Germany, this paper aims to identify policies, structures, and practices of the German health care system that influence the uptake and use of a PHR. METHODS: A total of 33 semistructured interviews were conducted with a purposive sample of experts: 23 interviews with different health care professionals and 10 interviews with key actors of the German health care system who were telematics, eHealth, and information technology experts (eHealth experts). The interviews were transcribed verbatim and subjected to a content analysis. RESULTS: From the expert perspective, a PHR was basically considered desirable and unavoidable. At the same time, a number of challenges for implementation in Germany have been outlined. Three crucial themes emerged: (1) documentation standards: prevailing processes of the analog bureaucratic paper world, (2) interoperability: the plurality of actors and electronic systems, and (3) political structure: the lack of clear political regulations and political incentive structures. CONCLUSIONS: With regard to the implementation of a PHR, an important precondition of a successful digitalization will be the precedent reform of the system to be digitized. Whether the recently passed Act for Faster Appointments and Better Care will be a step in the right direction remains to be seen.

Caregivers' role in using a personal electronic health record: a qualitative study of cancer patients and caregivers in Germany.

BACKGROUND: Particularly in the context of severe diseases like cancer, many patients wish to include caregivers in the planning of treatment and care. Many caregivers like to be involved but feel insufficiently enabled. This study aimed at providing insight into patients' and caregivers' perspectives on caregivers' roles in managing the patient portal of an electronic personal health record (PHR). METHODS: A descriptive qualitative study was conducted comprising two study phases: (1) Usability tests and interviews with patients with cancer and caregivers (2) additional patient interviews after a 3-month-pilot-testing of the PHR. For both study parts, a convenience sample was selected, focusing on current state of health and therapy process and basic willingness to participate and ending up with a mixed sample as well as saturation of data. All interviews were audio-recorded, pseudonymized, transcribed verbatim and qualitatively analyzed. RESULTS: Two main categories emerged from qualitative data: 'Caregivers' role' and 'Graduation of access rights' - consisting of four subcategories each. The interviewed patients (n = 22) and caregivers (n = 9) felt that the involvement of caregivers is central to foster the acceptance of a PHR for cancer patients. However, their role varied from providing technical support to representing patients, e.g. if the patient's state of health made this necessary. Heterogeneous opinions emerged regarding the question whether caregivers should receive full or graduated access on a patient's PHR. CONCLUSIONS: In order to support the patient and to participate in the care process, caregivers need up-to-date information on the patient's health and treatment. Nevertheless, some patients do not want to share all medical data with caregivers, which might strain the patient-caregiver relationship. This needs to be considered in development and implementation of personal health records. Generally, in the debate on patient portals of a personal health record, paying attention to the role of caregivers is essential. By appreciating the important relationship between patients and caregivers right from the beginning, implementation, of a PHR would be enhanced. TRIAL REGISTRATION: ISRCTN85224823 . Date of registration: 23/12/2015 (retrospectively registered).

"Rather one more chemo than one less ": Oncologists and Oncology Nurses' Reasons for Aggressive Treatment of Young Adults with Advanced Cancer.

BACKGROUND: Empirical research demonstrates that there is a tendency to administer tumor-directed therapy to patients with advanced cancer close to death, especially if they are young. The aim of this qualitative study was to understand oncologists' treatment decisions and oncology nurses' perception of these decisions in young adult patients and to investigate the extent to which young age was a factor in cancer treatment decisions. MATERIALS AND METHODS: We conducted 29 face-to-face interviews with oncologists and oncology nurses at the Department of Hematology and Oncology at the University Hospital in Munich, Germany. The interviews were analyzed according to the grounded theory approach. RESULTS: Oncologists and nurses reported that decisions about limiting cancer treatment with young adult patients are the most challenging and stressful in clinical practice. Apart from using young age as a proxy for patient's medical fitness, oncologists' decisions in favor of more aggressive treatment of younger patients were mainly guided by ethical reasons such as patient preferences and the perceptions of injustice associated with dying at a young age, as well as by psychological reasons, such as identification and emotional entanglement. CONCLUSION: "Struggling" together with the patient against the injustice of dying young for a longer lifetime is an important factor driving aggressive treatment in young adult patients. However, oncologists might run a risk of neglecting other ethical aspects, such as a principle of nonmaleficence, that might even result in life-shortening adverse events. IMPLICATIONS FOR PRACTICE: This study identifies two ethical and one psychological reasons for patients' overtreatment: 1) patients' preference for further treatment; 2) oncologists' perception of un-fairness of dying young; and 3) identification and emotional entanglement with patient. These findings emphasize the need for oncologists' awareness of the reasons guiding their treatment decisions - a sole focus on patients' preferences and on the fighting against the unfairness of dying young might lead to neglecting obligations of non-maleficence. Self-reflection, the balance of empathy and professional distance as well as timely end of life discussions and involvement of psycho-oncologists are needed in the care of young cancer patients.

High prevalence of moral distress reported by oncologists and oncology nurses in end-of-life decision making.

OBJECTIVE: Decisions to limit life-prolonging treatment (DLT) are often accompanied by psychological and ethical difficulties. The aim of the study is to investigate prevalence and intensity of moral distress (MD) as well as potential causes experienced by oncology physicians and nurses in DLT situations. METHODS: This prospective study at a German university hospital included n = 100 advanced cancer inpatients with DLT. We surveyed their respective physicians and nurses to assess MD in DLT using an adapted distress thermometer and an open-ended question to specify reasons of MD. We also collected data on the decision-making process from the perspective of the clinicians. RESULTS: Physicians report MD in 67% (n = 51) and nurses in 74% (n = 67) of the cases. The MD level in nurses (mean 2.3; SD 2.3) is significantly higher (P = .005) than in physicians (mean 1.5; SD 1.4). Uncertainties concerning ethical aspects in DLT in a patient case are associated with MD in both physicians (P = .024) and nurses (P = .004). Involvement of nurses in DLT is the strongest predictor (P = .000) for MD as indicated by physicians. Nurses experience MD especially, if the patient has a low quality of life (P = .001). CONCLUSIONS: Moral distress is experienced by both oncologists and nurses in DLT. Nurses report higher MD intensity compared with physicians although the ultimate responsibility for DLT lies with the physicians. Support for the challenging decisions may be provided through the implementation of an ethical guideline and enhanced interprofessional communication.

Trust and responsibility in molecular tumour boards.

Molecular tumour boards (MTBs) offer recommendations for potentially effective, but potentially burdensome, molecularly targeted treatments to a patient's treating physician. In this paper, we discuss the question of who is responsible for ensuring that there is an adequate evidence base for any treatments recommended to a patient. We argue that, given that treating oncologists cannot usually offer a robust evaluation of the evidence underlying an MTB's recommendation, members of the MTB are responsible for ensuring that the evidence level is adequate. We explore two models for how to share responsibility between MTB members. According to the first model, each MTB member, as well as the treating physician, should be held maximally and equally responsible for the recommendations. We argue that this insufficiently accounts for differences in roles and expertise of MTB members. We propose instead that responsibility is delegated via relationships of trust. We argue if these relationships of trust are to be instances of reasonable trust, (a) MTBs should offer a clinical representative to whom a treating physician may delegate the responsibility of ensuring there is sufficient evidence for treatment recommendations, (b) the relationships of trust between the representative and the other MTB members should be clearly defined, and (c) MTB members should be carefully selected. Treating oncologists retain a responsibility to consider general limitations of the evidence for targeted treatments in assessing whether the treatment recommendation offered by an MTB's representative is adequate for a given clinical situation.

The second patient? Family members of cancer patients and their role in end-of-life decision making.

BACKGROUND: Family members are important companions of severely ill patients with cancer. However, studies about the desirability and difficulties of integrating relatives in the decision-making process are rare in oncology. This qualitative study explores the family role in decisions to limit treatment near the end of life from the professionals' point of view. METHODS: Qualitative in-depth interviews were conducted with oncologists (n = 12) and nurses (n = 6) working at the Department of Hematology/Oncology at the University Hospital in Munich, Germany. The data were analyzed using a descriptive qualitative methodology and discussed from a medical ethics perspective. RESULTS: Four major themes played a central role in the perception of the medical staff in regard to family members. (1) Family impact on patients' treatment preferences. (2) Strong family wish for further treatment. (3) Emotional distress of the family related to the involvement in end-of-life decision-making. (4) Importance of knowing family structures. CONCLUSIONS: The important role of the family members in patients' disease process is recognized by oncologists and oncology nurses. However, this does not seem to lead to an early involvement of the family members. Developing and establishing a systematic assessment of family members' needs and wishes in order to provide a specific-tailored support should become a priority for interdisciplinary clinical research in the near future.

Applying systems biology to biomedical research and health care: a précising definition of systems medicine.

BACKGROUND: Systems medicine has become a key word in biomedical research. Although it is often referred to as P4-(predictive, preventive, personalized and participatory)-medicine, it still lacks a clear definition and is open to interpretation. This conceptual lack of clarity complicates the scientific and public discourse on chances, risks and limits of Systems Medicine and may lead to unfounded hopes. Against this background, our goal was to develop a sufficiently precise and widely acceptable definition of Systems Medicine. METHODS: In a first step, PubMed was searched using the keyword "systems medicine". A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing Systems Medicine in title or abstract were screened for definitions. Definitions were extracted; their semantic elements were assigned as either means or ends. To reduce complexity of the resulting list, summary categories were developed inductively. In a second step, we applied six criteria for adequate definitions (necessity, non-circularity, non-redundancy, consistency, non-vagueness, and coherence) to these categories to derive a so-called précising definition of Systems Medicine. RESULTS: We identified 185 articles containing the term Systems Medicine in title or abstract. 67 contained at least one definition of Systems Medicine. In 98 definitions, we found 114 means and 132 ends. From these we derived the précising definition: Systems Medicine is an approach seeking to improve medical research (i.e. the understanding of complex processes occurring in diseases, pathologies and health states as well as innovative approaches to drug discovery) and health care (i.e. prevention, prediction, diagnosis and treatment) through stratification by means of Systems Biology (i.e. data integration, modeling, experimentation and bioinformatics). Our study also revealed the visionary character of Systems Medicine. CONCLUSIONS: Our insights, on the one hand, allow for a realistic identification of actual ethical as well as legal issues arising in the context of Systems Medicine and, in consequence, for a realistic debate of questions concerning its matter and (future) handling. On the other hand, they help avoiding unfounded hopes and unrealistic expectations. This especially holds for goals like improving patient participation which are intensely debated in the context of Systems Medicine, however not implied in the concept.

When do we need to care about the caregiver? Supportive care needs, anxiety, and depression among informal caregivers of patients with cancer and cancer survivors.

BACKGROUND: Cancer not only affects patients but also their caregivers. The objective of the current study was to assess the unmet needs of cancer caregivers and to identify possible predictors of their supportive care needs. METHODS: In a cross-sectional survey, 188 dyads of patients diagnosed with lung, urological, or gastrointestinal cancer and their primary caregivers were recruited. Caregivers were asked to complete the Supportive Care Needs Survey self-report questionnaire (for partners and caregivers); patients completed the corresponding questionnaire. Both groups provided information regarding their distress (National Comprehensive Cancer Network Distress Thermometer), anxiety, and depression (Patient Health Questionnaire-4). Clinical characteristics were obtained from medical records. RESULTS: The mean age of the caregivers was 57.8 years. Approximately 72.3% were female. Patients had an average age of 62.5 years, with 33.0% being male. Caregivers were more distressed (P<.01) and exhibited higher anxiety scores (P<.01) compared with patients. Approximately 14.4% of caregivers reported no unmet need and 43.6% had at least 10 needs that were unmet. Main caregiver concerns were regarding health care service and information needs followed by emotional and psychological needs. To some degree, unmet needs in patients and caregivers' anxiety predicted unmet caregiver needs. Sociodemographic and clinical variables were not found to be significant predictors. CONCLUSIONS: A substantial percentage of caregivers have unmet needs for support, mainly with regard to fears concerning the patient's condition, receiving disease-related information, and emotional support for themselves. Prediction of unmet needs in caregivers from other clinical and psychological variables was rather poor. Therefore, by means of the frequency and disparity of caregivers unmet needs, they should be systematically assessed to direct specific offers.

What keeps oncologists from addressing palliative care early on with incurable cancer patients? An active stance seems key.

BACKGROUND: Sympathetic and frank communication about the terminal nature of advanced cancer is important to improve patients' prognostic understanding and, thereby, to allow for adjustment of treatment intensity to realistic goals; however, decisions against aggressive treatments are often made only when death is imminent. This qualitative study explores the factors that hinder such communication and reconstructs how physicians and nurses in oncology perceive their roles in preparing patients for end-of-life (EOL) decisions. METHODS: Qualitative in-depth interviews were conducted with physicians (n = 12) and nurses (n = 6) working at the Department of Hematology/Oncology at the university hospital in Munich, Germany. The data were analyzed using grounded theory methodology and discussed from a medical ethics perspective. RESULTS: Oncologists reported patients with unrealistic expectations to be a challenge for EOL communication that is especially prominent in comprehensive cancer centers. Oncologists responded to this challenge quite differently by either proactively trying to facilitate advanced care planning or passively leaving the initiative to address preferences for care at the EOL to the patient. A major impediment to the proactive approach was uncertainty about the right timing for EOL discussions and about the balancing the medical evidence against the physician's own subjective emotional involvement and the patient's wishes. CONCLUSION: These findings provide explanations of why EOL communication is often started rather late with cancer patients. For ethical reasons, a proactive stance should be promoted, and oncologists should take on the task of preparing patients for their last phase of life. To do this, more concrete guidance on when to initiate EOL communication is necessary to improve the quality of decision making for advanced cancer patients.

Assessing patient-caregiver communication in cancer--a psychometric validation of the Cancer Communication Assessment Tool (CCAT-PF) in a German sample.

PURPOSE: The recently introduced Cancer Communication Assessment Tool (CCAT-PF) measures congruence in patient-caregiver communication and was initially validated in lung cancer patients. Contributing to a greater proportion of the variance in the conflict scores, primary caregivers were hypothesized to experience greater stress. For a detailed understanding of conflicting communication patterns of cancer-affected families, our study aimed for psychometric validation of the CCAT-PF in a sample covering heterogeneous tumor entities. METHODS: Subsequent to a cross-sectional survey of 189 pairs of cancer patients (31 % gastrointestinal, 34 % lung, and 35 % urological) and their caregivers' exploratory factor analysis with principal component condensation and varimax rotation was conducted (response rate, 74.2 %). Reliability and construct validity were assessed calculating Cronbach's α and Pearson correlation coefficients for CCAT-P and CCAT-F scales and related constructs, respectively. RESULTS: Cancer-related communication according to the CCAT-PF can be subdivided into four factors including the scales Disclosure, Limitation of treatment, Family involvement in treatment decisions, and Continuing treatment. Reliability ranged from α = .51-.68. The Disclosure scale, describing poor cancer-related communication of the patient, was correlated with patient's distress (QSC-R10: r = .30, p < .0001), unmet needs in several areas (SCNS-SF-34: r = .25-.32, p < .001), and negatively with social/family well-being (FACT: r = -0.31, p < .0001). Higher scores on the scale were significantly associated with considerable decrements in emotional well-being especially for caregivers perceiving patients' disclosure as problematic. CONCLUSIONS: The Disclosure scale originating from the CCAT-PF emerged as a short, valid, and reliable stand-alone instrument for identifying conflicting communication in patient-caregiver-dyads at risk.

Do Physicians Have a Duty to Support Secondary Use of Clinical Data in Biomedical Research? An Inquiry into the Professional Ethics of Physicians.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians' professional ethics to determine whether they include duties that can be considered as good reasons for a physicians' professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.