BACKGROUND: Physical activity (PA) and smoking cessation are included in the secondary prevention guidelines after myocardial infarction (MI), but they are still underutilised. This study aims to e ...

/pdf/physical-inactivity-and-smoking-after-myocardial-infarction-1crebzr4e7.pdf

Physical inactivity and smoking after myocardial infarction as predictors for readmission and survival: results from the SWEDEHEART-registry

/pdf/values-and-ethics-in-information-systems-31d9f0dc.pdf

Values and Ethics in Information Systems

Genetic research is advancing rapidly. One important area for the application of the results from this work is personalized health. These are treatments and preventive interventions tailored to the genetic profile of specific groups or individuals. The inclusion of personalized health in existing health systems is a challenge for policymakers. In this article, we present the results of a thematic scoping review of the literature dealing with governance and policy of personalized health. Our analysis points to four governance challenges that decisionmakers face against the background of personalized health. First, researchers have highlighted the need to further extend and harmonize existing research infrastructures in order to combine different types of genetic data. Second, decisionmakers face the challenge to create trust in personalized health applications, such as genetic tests. Third, scholars have pointed to the importance of the regulation of data production and sharing to avoid discrimination of disadvantaged groups and to facilitate collaboration. Fourth, researchers have discussed the challenge to integrate personalized health into regulatory-, financing-, and service provision structures of existing health systems. Our findings summarize existing research and help to guide further policymaking and research in the field of personalized health governance.

/pdf/governing-personalized-health-a-scoping-review-21m45ypz0n.pdf

Governing Personalized Health: A Scoping Review.

FIFA World Cup 2018: effect of emotional stress on conventional heart rate variability metrics.

BACKGROUND In Germany, the drug law was revised in 2016 to include new regulations on clinical drug trials with adults who lack decision-making capacity. For the first time, trials with a merely indirect benefit (benefit for other patients with similar characteristics) will be possible if several safeguards are respected. The ethical justification and practicality of this regulation are controversially discussed. OBJECTIVES (1) Eliciting the current pertinent practice of research ethics committees in Germany regarding research with indirect benefit on adults without decision-making capacity; (2) exploring the possibilities and difficulties of implementing the new law. METHODS Semiquantitative, anonymous questionnaire among 249 members of all 53 human research ethics committees in Germany. RESULTS Eighty-four questionnaires were analyzed (response rate 34%). The participants disagreed on assigning research projects to the categories of research with direct benefit to the subject, with an indirect benefit, and without any benefit. Moreover, the criteria of minimum risk and minimum burden were interpreted heterogeneously. More than half of the participants judged the newly introduced research advance directive to be unnecessary, given the legal safeguards in place. The applicability of these directives was doubted because of the strict requirements for anticipatory informed consent and the restricted predictability of future research. CONCLUSION In spite of the new legal regulation, significant ethical uncertainties remain concerning research with indirect benefit on adults without decision-making capacity. It remains an open question whether we need a better explanation of the law, additional legal regulation, practice evaluation, or a completely new law.

/pdf/critical-evaluation-of-the-new-legal-regulation-of-8ws0ewy2vm.pdf

[Critical evaluation of the new legal regulation of pharmaceutical trials with adults who lack decision-making capacity: a survey of human research ethics committees in Germany].

Sufficient exercise and sleep, a balanced diet, moderate alcohol consumption and a good approach to handle stress have been known as lifestyles that protect health and longevity since the Middle Age. This traditional prevention quintet, turned into a sextet by smoking cessation, has been the basis of the "preventive personality" that formed in the twentieth century. Recent analyses of big data sets including genomic and physiological measurements have unleashed novel opportunities to estimate individual health risks with unprecedented accuracy, allowing to target preventive interventions to persons at high risk and at the same time to spare those in whom preventive measures may not be needed or even be harmful. To fully grasp these opportunities for modern preventive medicine, the established healthy life styles require supplementation by stratified prevention. The opportunities of these developments for life and health contrast with justified concerns: A "surveillance society", able to predict individual behaviour based on big data, threatens individual freedom and jeopardises equality. Social insurance law and the new German Disease Prevention Act (Praventionsgesetz) rightly stress the need for research to underpin stratified prevention which is accessible to all, ethical, effective, and evidence based. An ethical and acceptable development of stratified prevention needs to start with autonomous individuals who control and understand all information pertaining to their health. This creates a mandate for lifelong health education, enabled in an individualised form by digital technology. Stratified prevention furthermore requires the evidence-based development of a new taxonomy of cardiovascular diseases that reflects disease mechanisms. Such interdisciplinary research needs broad support from society and a better use of biosamples and data sets within an updated research governance framework.

/pdf/stratified-prevention-opportunities-and-limitations-report-4w3wwnn0gx.pdf

Stratified prevention: opportunities and limitations. Report on the 1st interdisciplinary cardiovascular workshop in Augsburg.

Forschung mit nicht einwilligungsfahigen volljahrigen Patienten ist praktisch notwendig, um Erkenntnisse uber ihre spezifischen Krankheiten zu gewinnen. Sie bedarf aber zugleich hoher Schutzstandards, da sich diese Gruppe nicht selbst vor Schaden und Risiken bewahren kann. Um Schutz zu gewahrleisten, mussen Studien mit geringen Risiken verbunden sein, einen Nutzen erwarten lassen, subsidiar gegenuber Studien an einwilligungsfahigen erwachsenen sein, durch eine Ethikkommission kontrolliert werden und die Zustimmung des gesetzlichen Vertreters enthalten. Wahrend auf nationaler und internationaler Ebene ein weitgehender Konsens uber diese Grundvoraussetzungen besteht, gibt es Abweichungen im Detail und bei weiteren Erfordernissen.

Nicht einwilligungsfähige, volljährige Patienten

Kinder und Jugendliche entwickeln erst mit zunehmendem Alter die Medizinischer Fortschritt fur Kinder und Jugendliche kann nur durch Forschung an ihnen selbst erreicht werden. Dabei ist diese Gruppe besonders schutzbedurftig, da ihnen selbst die Fahigkeit zur Einwilligung in Studien in jungen Jahren fehlt. Hier ist es Aufgabe der Erziehungsberechtigten, der Forscherteams und Ethikkommissionen, einen Ausgleich zwischen Erkenntnisgewinn und Schutz des minderjahrigen Studienteilnehmers zu erreichen.

Studien mit Kindern und Jugendlichen – aus rechtlicher Sicht

Patient autonomy is not only the dominant principle of medical ethics, but also important in criminal law, as it is the main justification for otherwise criminal behaviour by physicians who intervene in the treatment of patients. The chapter analyses the concept of informed consent in relevant areas of criminal law, such as living wills, euthanasia, physician curative interventions, coercive cosmetic surgery, and enhancements. It is found that the existing concept of informed consent does not sufficiently account for the multiple facets of patient autonomy. The author therefore proposes a concept of patient autonomy that is viable from an ethical perspective, useful for medical practice, and applicable to criminal law. 

Patient autonomy and criminal law

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Stratified prevention: opportunities and limitations. Report on the 1st interdisciplinary cardiovascular workshop in Augsburg.

Nicht einwilligungsfähige, volljährige Patienten

Studien mit Kindern und Jugendlichen – aus rechtlicher Sicht

Patient autonomy and criminal law