Personalised medicine: Priority setting and opportunity costs in European public health care systems

“Personalised medicine” is currently attracting considerable attention and raising high hopes and expectations in modern medicine. The term “personalised medicine” denotes the use of genetic or other biomarker information, and it does not focus on a more personal patient-doctor relationship. Furthermore, personalised medicine is associated with ethical problems like priority setting and opportunity costs in solidarity-based public health care systems. Personalised medicine provides modern, highly specific and expensive diagnostics and treatments, which serve only limited subgroups of patients. At the same time, research in other fields of clinical medicine, which could be of benefit to more patients than such limited subgroups, remain underfunded

Personalised medicine: Priority setting and opportunity costs in European public health care systems

“Personalised medicine” is currently attracting considerable attention and raising high hopes and expectations in modern medicine. The term “personalised medicine” denotes the use of genetic or other biomarker information, and it does not focus on a more personal patient-doctor relationship. Furthermore, personalised medicine is associated with ethical problems like priority setting and opportunity costs in solidarity-based public health care systems. Personalised medicine provides modern, highly specific and expensive diagnostics and treatments, which serve only limited subgroups of patients. At the same time, research in other fields of clinical medicine, which could be of benefit to more patients than such limited subgroups, remain underfunded

As diretrizes avançadas na américa latina. Um análise ético de caso da Argentina

In recent years, advance directives (ADs) have been increasingly incorporated into Latin American societies as an instrument that allows patients to specify how they would like to be treated in the event that they are no longer competent. Their main goal is, therefore, to increase respect towards the autonomy of patients. However, learning from the experience yielded by ADs in other countries, in order to work out the best way to implement them is important to achieve this end. Identifying potential facilitators and barriers to carry out such a project that can be found in the Latin American context is also important. In this article, we will analyze the evolution of ADs in the U.S., focusing especially on the difficulties faced during this process which arise mainly from an overly individualistic approach to the process of decision-making. In contrast, we will argue that the role usually played by families or other people close to the patient, in Latin American societies offers favorable conditions to implement a more relational approach, able to overcome the problems encountered by the individualistic model. Nevertheless, we will also argue that significant efforts are needed to improve the quality of the physicianpatient-family relationship. In particular, overcoming the paternalistic actions still exerted by some physicians, often concerning relatives, constitutes a necessary condition for the implementation of ADsEn años recientes, las directivas anticipadas (DAs) han sido incorporadas de manera creciente en las sociedades latinoamericanas como un instrumento que permite a los pacientes especificar el modo en que desearían ser tratados en caso de que no sean competentes. El objetivo principal de estos instrumentos es, por lo tanto, incrementar el respeto por la autonomía de los pacientes. No obstante, es importante para ello conocer la experiencia que arrojaron las DAs en otros países, para poder diseñar así la mejor manera de implementarlas. Igualmente importante es identificar posibles facilitadores y barreras que pudiera ofrecer el contexto latinoamericano para llevar a cabo dicho proyecto. En este artículo se analiza la evolución de las DAs en los Estados Unidos, se concentra especialmente en las dificultades que surgieron a lo largo de este proceso, y que se deben fundamentalmente a un abordaje excesivamente individualista del proceso de toma de decisiones. En contraste con ello, se argumenta que el rol importante que desempeñan generalmente las familias, u otras personas cercanas al paciente, en las sociedades Latinoamericanas ofrece condiciones favorables para lograr un abordaje más relacional, capaz de superar los problemas del modelo individualista. Sin embargo, se argumenta también que se necesitan esfuerzos importantes para mejorar la calidad de la relación médico-paciente-familia. En particular, la superación de las acciones paternalistas todavía ejercidas por algunos médicos, frecuentemente en conjunto con los familiares, constituye una condición necesaria para la implementación de las DAs.Nos últimos anos, as directivas de avanço foram incorporadas cada vez mais nas sociedades latino-americanas como um instrumento que permite aos pacientes especificar o modo em que gostaria de ser tratado quando eles não são competentes. O principal objectivo destes instrumentos é então aumentar o respeito pela autonomia dos pacientes. No entanto, é importante conhecer a experiência de avanço de políticas em outros países, para projetar a melhor maneira de implementá-las também. É importante também identificar potenciais facilitadores e barreiras que poderiam ofrecer o contexto latino-americano para realizar este projeto. Este artigo discute a evolução do avanço de políticas nos Estados Unidos, especialmente focando as dificuldades que surgiram durante o processo, e que é devido primeiramente a uma abordagem excessivamente individualista do processo decisório. Em contrapartida, defendemos que o papel importante que as famílias, ou outras pessoas próximas do paciente nas sociedades latino-americanas, geralmente oferece condições favoráveis para alcançar uma abordagem mais relacional, capaz de superar os problemas do modelo individualista. Também discutimos a grande necessidade de esforços para melhorar a qualidade da relação médico-paciente-família. Em particular, a superação das ações paternalistas exercidas por alguns médicos, muitas vezes em conjunto com membros da família, constitui uma condição necessária para a aplicação das directivas de avanço

a review of empirical data and ethical analysis

Background Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. Methods Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns. Results The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies. Conclusion The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved

Regulating open disclosure: a German perspective

The issue of open disclosure has received growing attention from policy-makers, legal experts and academic researchers, predominantly in a number of English-speaking countries. While implementing open disclosure in practice is still an on-going process, open disclosure now forms an integral part of health policy in various American states, the UK, Canada, Australia and New Zealand, with a number of measures having been put in place to encourage open disclosure and to mitigate some of the barriers to such open communication. In contrast, this issue has received little attention in non-English-speaking countries and there is currently no empirical data relating to actual practice or practitioners' attitudes and views in most countries in continental Europe. This article critically examines Germany's current approach to open disclosure. It finds that the issue plays no significant role in German health policy with very limited measures explicitly concerning such communication currently in place. While a number of aspects of the wider regulatory framework appear to be supportive, Germany is still in the early stages of a systematic approach and additional measures are required to further promote open disclosure within the self-governing German healthcare system. This exploration provides an example of a non-English-speaking country's approach to open disclosure and may be of particular interest to neighbouring German-speaking and civil law countries such as Switzerland and Austri

Research participants’ perceptions and views on consent for biobank research: a review of empirical data and ethical analysis

BACKGROUND: Appropriate information and consent has been one of the most intensely discussed topics within the context of biobank research. In parallel to the normative debate, many socio-empirical studies have been conducted to gather experiences, preferences and views of patients, healthy research participants and further stakeholders. However, there is scarcity of literature which connects the normative debate about justifications for different consent models with findings gained in empirical research. In this paper we discuss findings of a limited review of socio-empirical research on patients’ and healthy research participants’ experiences and views regarding consent to biobank research in light of ethical principles for appropriate information and consent. METHODS: Review question: Which empirical data are available on research participants’ perceptions and views regarding information and elicitation of consent for biobank research? Search of articles published till March 1st 2014 in Pubmed. Review of abstracts and potentially relevant full text articles by two authors independently. As categories for content analysis we defined (i) understanding or recall of information, (ii) preferences regarding information or consent, and (iii) research participants’ concerns. RESULTS: The search in Pubmed yielded 337 abstracts of which 10 articles were included in this study. Approaches to information and consent varied considerably across the selected studies. The majority of research participants opted for some version of limited consent when being informed about such possibility. Among the factors influencing the type of preferred consent were information about sponsoring of biobank research by pharmaceutical industry and participants’ trade-off between privacy and perceived utility. Studies investigating research participants’ understanding and recall regarding the consent procedure indicated considerable lack of both aspects. Research participants’ perceptions of benefits and harms differ across those studies. CONCLUSION: The knowledge, perceptions and views of research participants who have undergone a consent procedure within the context of biobank research raise several questions on the issue of how to inform and elicit consent in an ethically acceptable way. In our empirical-ethical analysis we develop suggestions on how the practice of eliciting consent in the biobank context should be improved

Limiting treatment and shortening of life: data from a cross-sectional survey in Germany on frequencies, determinants and patients' involvement

Background: Limiting treatment forms part of practice in many fields of medicine. There is a scarcity of robust data from Germany. Therefore, in this paper, we report results of a survey among German physicians with a focus on frequencies, aspects of decision making and determinants of limiting treatment with expected or intended shortening of life. Methods: Postal survey among a random sample of physicians working in the area of five German state chambers of physicians using a modified version of the questionnaire of the EURELD Consortium. Information requested referred to the patients who died most recently within the last 12 months. Logistic regression was performed to analyse associations between characteristics of physicians and patients regarding limitation of treatment with expected or intended shortening of life. Results: As reported elsewhere, 734 physicians responded (response rate 36.9%) and of these, 174 (43.2%) reported a withholding and 144 (35.7%) a withdrawal of treatment. Eighty one physicians estimated that there was at least some shortening of life as a consequence. In 25.9% of these cases hastening death had been discussed with the patient at the time or immediately prior to this action. Types of treatment most frequently limited was artificial nutrition (n = 35). Bivariate analysis indicates that limitation of treatment with possible or intended shortening of life for patients aged > 75 years is performed significantly more often (p = 0.007, OR 1.848). There was significantly less limitation of treatment in patients who died from cancer compared to patients with other causes of death (p = 0.01, OR 0.486). There was no significant statistical association with physicians' religion, palliative care qualification or frequencies of limiting treatment. Conclusions: In comparison to recent research from other European countries, limitation of treatment with expected or intended shortening of life is frequently performed amongst the investigated sample. The role of clinical and non-medical aspects possibly relevant for physicians' decision about withholding or withdrawal of treatment with possible or intended shortening of life and reasons for non-involvement of patients should be explored in more detail by means of mixed method and interdisciplinary empirical-ethical analysis

Plant breeding for increased sustainability: challenges, opportunities and progress

Humanity is facing enormous challenges in the years to come: sustainability of agriculture and sustainability of our supply with food, feed and renewable materials are neither granted nor free. Especially, but not only, in the Global South, a sustainable increase in agricultural productivity and a steady reduction of avoidable losses are undoubtedly key issues that need to be addressed. In order to pinpoint the most pressing challenges and strategies to achieve targets, the United Nations have formulated the Sustainable Development Goals (https://sdgs. un.org/goals). Among these, several are directly or indirectly addressing agriculture, food supply and sustainability, most notably SDG2 (zero hunger), SDG12 (responsible consumption and production), SDG13 (climate action) and SDG15 (life on land)

Möglichkeiten und Grenzen von Ethikberatung im Rahmen der COVID-19-Pandemie

<jats:title>Zusammenfassung</jats:title><jats:p>Wie ist der Freiwillige Verzicht auf Essen und Trinken und eine medizinische Begleitung dabei ethisch zu bewerten? Die ethische Bewertung des Freiwilligen Verzichts auf Essen und Trinken stellt Patienten und Angehörige, aber auch begleitende Ärzte und Pflegende vor erhebliche Schwierigkeiten. Basierend auf Ergebnissen eigener qualitativer Interviews mit Personen nach dem FVET ihrer Angehörigen legt dieser Artikel die bestehende Unklarheit und inhärente ethische Ambivalenz des Begriffs FVET frei, stellt aber in der Unterscheidung von FVET-Fällen – mit bzw. ohne terminale Erkrankung – einen Weg zur Lösung der Frage nach der ethischen Bewertung des „Sterbefastens“ und seiner medizinischen Begleitung vor: Ethisch wird der Freiwillige Verzicht auf Essen und Trinken und seine medizinische Begleitung erst in der Analyse von Situation und Intention der Handelnden beurteilbar. Ausgehend vom Konzept eines frei gewollten Verzichts auf Essen und Trinken bei einsichts- und einwilligungsfähigen Personen mit dem Bewusstsein, damit ihr Leben zu verkürzen oder zu beenden, wird mit der Philosophie Thomas von Aquins argumentiert, dass eine ethische Bewertung die Begleitumstände und beabsichtigten Ziele miteinschließen muss, ebenso wie die Auswirkungen auf Angehörige und die Implikationen von und für ein Behandlungsteam.</jats:p&gt

Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study

Aim To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators (CRT-Ds) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death. Methods and results Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option. Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospectively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5%. Seven parameters were included in the algorithm: mean heart rate over 24 h, heart rate at rest, patient activity, frequency of ventricular extrasystoles, atrial–atrial intervals (heart rate variability), right ventricular pacing impedance, and painless shock impedance. The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death. While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0%, the combination of all parameters was 65.4% sensitive in detecting cardiovascular hospitalizations and deaths with 99.5% specificity (corresponding to 1.83 false-positive detections per patient-year of follow-up). The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding. Conclusion We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring. This tool may increase patients’ quality of life and reduce morbidity, mortality, and health economic burden, it now warrants prospective studies