Ethisch begründet entscheiden in der Intensivmedizin.

The process recommendations of the Ethics Section of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) for ethically based decision-making in intensive care medicine are intended to create the framework for a structured procedure for seriously ill patients in intensive care. The processes require appropriate structures, e.g., for effective communication within the treatment team, with patients and relatives, legal representatives, as well as the availability of palliative medical expertise, ethical advisory committees and integrated psychosocial and spiritual care services. If the necessary competences and structures are not available in a facility, they can be consulted externally or by telemedicine if necessary. The present recommendations are based on an expert consensus and are not the result of a systematic review or a meta-analysis.

The Right to Know and not to Know: Predictive Genetic Diagnosis and Non-diagnosis.

The expansion of genetic diagnostic potential in the direction of future contingencies (risks) creates temptations and compulsions for timely knowledge and responsible-sometimes radical-prevention. In the area of mamma carcinoma, the 'Angelina Jolie effect' has not only been a media topic but has had real consequences. The undisputed right to knowledge is increasingly taking on the character of a general recommendation or even norm for society as a whole, regardless of the possibly toxic consequences of discovering a predisposition. In an "enlightened knowledge society" in which health and illness increasingly "appear as products of our own actions" (Giovanni Maio), not wanting to know is difficult; thus, it is all the more significant that this concept has found widespread recognition in current law. Its legal practical implementation, however, presents several questions that have not yet been fully clarified, for example in connection with incidental medical findings or family members affected as third parties. It is also unclear how, in the age of next-generation sequencing and the standardizing digitalization of medicine and society, it will be possible to counteract the cultural bias in favour of knowledge, even outside the law.

Quality of life and mental health in adolescent users of oral contraceptives. Results from the nationwide, representative German Health Interview and Examination Survey for Children and Adolescents (KiGGS).

OBJECTIVE: Using data from the nationwide, cross-sectional KiGGS (German Health Interview and Examination Survey for Children and Adolescents) study, we investigated whether hormonal contraception in adolescents aged 15 to 17 years was linked to health-related quality of life and mental health problems. METHODS: Study participants had undergone standardized recordings of blood pressure and measurements of serum 25-hydroxyvitamin D [25(OH)D]. Quality of life was assessed by self- and parent-rated KINDL-R questionnaires, whereas mental health problems were screened by means of the Strengths and Difficulties Questionnaire (SDQ). RESULTS: Self-rated quality of life was similar between users (n = 522) and non-users (n = 1173, 69.2%) of oral contraceptives (69.2 ± 11.2 vs. 69.2 ± 11.0, p = 0.943), as was the parent-rated version (72.9 ± 10.6 vs. 72.9 ± 10.5, p = 0.985). Likewise, no significant differences were observed between the two groups with respect to both self- (10.9 ± 4.4 vs. 10.8 ± 4.6, p = 0.732) and parent-rated SDQ scores (7.2 ± 4.8 vs. 7.0 ± 4.6. p = 0.390). However, serum 25(OH)D (59.5 ± 32.9 vs. 46.1 ± 28.0 nmol/L, p < 0.001) and mean arterial blood pressure (88.2 ± 7.4 vs. 86.5 ± 7.7 mmHg, p < 0.001) were significantly higher in users than in non-users. There was a trend towards a higher rate of psychotropic drug prescription in participants taking oral contraceptive pills as compared to those not receiving hormonal contraception (17.8% vs. 14.4%, p = 0.052). A series of linear regression models with either KINDL-R or SDQ as dependent variable confirmed that there were no associations between components of mental well-being and contraceptive drug use, irrespective of whether self- or parent-ratings were included in these models. CONCLUSIONS: In a large, representative sample of German adolescents, exposure to exogenous contraceptive hormones was associated with higher arterial blood pressure and serum 25(OH)D concentration, whereas hormonal contraception was not linked to health-related quality of life or mental well-being.

A look into the future? Patients' and health care staff's perception and evaluation of genetic information and the right not to know.

The progress of medical genetics leads to a significant increase in genetic knowledge and a vast expansion of genetic diagnostics. However, it is still unknown how these changes will be integrated into medical practice and how they will change patients' and healthy persons' perception and evaluation of genetic diagnoses and genetic knowledge. Therefore, we carried out a comprehensive questionnaire survey with more than 500 patients, clients seeking genetic counseling, health care staff, and healthy persons (N = 523). The questionnaire survey covered detailed questions on the value of genetic diagnoses for the different groups of study participants, the right to know or not to know genetic diagnoses, possible differences between genetic and other medical diagnoses, and the practical use and implications of genetic knowledge with a special focus on hereditary neuropsychiatric diseases. A huge majority of the participants (90.7%) stated to have a right to learn every aspect of her or his genetic make-up. Similarly, study participants showed high interest (81.8%) in incidental health care findings-independent of whether the diseases are treatable or not. One can derive from the data outcome that study participants did not follow the implications of a "genetic exceptionalism" and often considered genetic findings as equivalent in relation to other medical diagnoses.

[Time-limited trials (TLT) in the intensive care unit : Recommendations from the ethics section of the DIVI and the ethics section of the DGIIN]. / Zeitlich begrenzter Therapieversuch ("time-limited trial", TLT) auf der Intensivstation : Handlungsempfehlung der Sektion Ethik der DIVI und der Sektion Ethik der DGIIN.

The rise in intensive care treatment procedures is accompanied by an increase in the complexity of decisions regarding the selection, administration and duration of treatment measures. Whether a treatment goal is desirable in an individual case and the treatment plan required to achieve it is acceptable for the patient depends on the patient's preferences, values and life plans. There is often uncertainty as to whether a patient-centered treatment goal can be achieved. The use of a time-limited treatment trial (TLT) as a binding agreement between the intensive care unit (ICU) team and the patient or their legal representative on a treatment concept over a defined period of time in the ICU can be helpful to reduce uncertainties and to ensure the continuation of intensive care measures in the patients' best interest.

[Provision planning at the end of life from a legal point of view]. / Vorsorgeplanung am Lebensende aus juristischer Sicht.

In the event of the loss of the ability to give consent and thus the possibility of legally validating one's own will, the law regularly provides for a mandatory third-party representation for the patient. However, their design can be influenced preventively, for which purpose those affected are given three options. These options are: patient's decree, health Power of Attorney, guardianship order. The patient's decree makes content related specifications as to which medical interventions are accepted or not accepted in which illnesses. Health Power of Attorney authorizes another person to make the necessary treatment decisions on behalf of the patient and guardianship order relates solely to the case of a possible guardianship appointment by the guardianship court. The written form of the advance directives forms an objective basis for mutual control of future decision-makers in the event of questions of interpretation. Absolute certainty that the current will of the patient corresponds to the future and that it is reliably determined and implemented in the decision-making situation is not possible. Nevertheless, the task is to come as close as possible to this ideal image in clinical reality.

[Selected legal aspects of end-of-life care : Euthanasia, palliative sedation and emergency medicine]. / Ausgewählte juristische Aspekte der Medizin am Lebensende : Sterbehilfe, palliative Sedierung und Notfälle.

The law distinguishes between several forms of intentional participation in life-shortening or life-ending acts ("euthanasia"). Therapy limitation is permitted or even required if the prerequisites for a medical intervention are no longer present. In contrast, active-direct killing (upon request) is categorically prohibited (§ 216 "Strafgesetzbuch" [StGB]). Considering the "fundamental right to self-determined dying", however, there is now a clear tendency to narrow the scope of punishable offences. This liberal "spirit of time" has already prevailed for assisted suicide, provided that it is carried out in a "freely responsible" manner. For pain therapy to reduce suffering, risks may be taken in light of the protection of life; however, here too, legitimization is required through the principle of actual or at least presumed consent. There are challenges in assessing and executing the patient's will in (suicidal) emergency situations, especially the adherence to autonomously made decisions on death.

[Selected legal aspects regarding limiting treatment at the end of life : Patient advance directive, proxy and indications]. / Ausgewählte juristische Aspekte der Therapiebegrenzung : Patientenverfügung, Stellvertretung und Indikation.

Respect for the patient's right to self-determination and the professional medical assessment of the (continued) existence of a therapeutic prospect of success of the respective curative intervention ("indication") are the two central reference parameters of every medical therapeutic decision. This is particularly true in cases of a progressive, irreversible, fatal course of the disease. However, the assessment of the presumed will of the patient or the meaningfulness of curative (intensive care) prolongation of life frequently causes difficulties. The law cannot eliminate these doubts in each individual case; it does, however, provide a framework so that factually and ethically justified therapy decisions can be made in each case. In this function, this legal framework-no matter how much it must first be concretized in the respective decision case-demands strict observance. This also includes the most recent change in the law that went into effect on 1 January 2023, through the introduction of a statutory right of (emergency) representation for spouses.

[The law of emergency representation in intensive care medicine]. / Notvertretungsrecht in der Intensivmedizin.

In case of patients who are incapable of decisionmaking, familiy members are only authorised for representative decisionmaking (in accordance with the presumed will of the patient) if they can submit a (written) health care disposition or have been appointed as guardians by court. In urgent cases, the court can also enforce the patient's right to self-determination itself by ruling (§â€Š1908i and §â€Š1846 BGB = German Civil Code). With effect from 01.01.2023, spouses will by law (automatically) become representatives in all matters of health care. However, this new regulation contains a number of conditions and reservations as well as it raises some questions about implementation in clinical practice.

[Ad hoc ethical decision-making in clinical acute and emergency medicine : Position paper of the Ethics Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care and Emergency Medicine (DGIIN)]. / Ethische Ad-hoc-Entscheidungsfindung in der klinischen Akut- und Notfallmedizin : Positionspapier der Sektion Ethik der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

Decisions with considerable medical and ethical implications are made in emergency departments every day. Despite time pressure and high workloads, they have to be arrived at in an expert manner in all dimensions. For immediate ethical decisions, structuring the decision-making process in the form of standard procedures can be helpful, provided that they are trained and practiced in an interdisciplinary and interprofessional manner. The support for ad hoc ethical decisions presented here recommends an "ethical team time out" for the evaluation of treatment choices, in a framework where the patient's will and medical indication are examined and completed in a structured manner. Further experts (ideally, an ad hoc clinical ethics consultation) should be consulted if the treatment measure is of questionable medical benefit and/or of questionable patient consent.

[Dealing with coercion in intensive care medicine : Recommendations from the Ethics Section of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society for Internal Intensive Care and Emergency Medicine (DGIIN)]. / Umgang mit Zwang in der Intensivmedizin : Empfehlung der Sektion Ethik der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

The treatment situation in intensive care is characterised by a specific asymmetry in the relationship between patients and the team: Patients are particularly dependent on their environment and often show impaired consciousness and capacity to consent. This facilitates the use of coercion or enables and/or provokes it. The aim of this recommendation is to show ways to recognise patients with their wishes and needs and to integrate them into treatment concepts in the intensive care unit in order to reduce and avoid coercion whenever possible. The recommendation shows the variety of possible forms of coercion and discusses the moral standards to be considered in the ethical weighing process as well as legal conditions for justifying its use. It becomes obvious that treatment measures which may involve the use of coercion always require a careful and self-critical review of the measures in relation to the indication and the therapeutic goal. The recommendation's intention therefore is not to disapprove the use of coercion by interprofessional teams. Instead, it aims to contribute to a sensitive perception of coercion and to a critical and caring approach to formal and especially informal (indirect) coercion.

[Overtreatment in intensive care medicine-recognition, designation, and avoidance : Position paper of the Ethics Section of the DIVI and the Ethics section of the DGIIN]. / Überversorgung in der Intensivmedizin: erkennen, benennen, vermeiden : Positionspapier der Sektion Ethik der DIVI und der Sektion Ethik der DGIIN.

Despite social laws, overtreatment, undertreatment, and incorrect treatment are all present in the German health care system. Overtreatment denotes diagnostic and therapeutic measures that are not appropriate because they do not improve the patients' length or quality of life, cause more harm than benefit, and/or are not consented to by the patient. Overtreatment can result in considerable burden for patients, their families, the treating teams, and society. This position paper describes causes of overtreatment in intensive care medicine and makes specific recommendations to identify and prevent it. Recognition and avoidance of overtreatment in intensive care medicine requires measures on the micro-, meso- and macrolevels, especially the following: (1) frequent (re-)evaluation of the therapeutic goal within the treating team while taking the patient's will into consideration, while simultaneously attending to the patients and their families; (2) fostering a patient-centered corporate culture in the hospital, giving priority to high-quality patient care; (3) minimizing improper incentives in health care financing, supported by reform of the reimbursement system that is still based on diagnose-related groups; (4) strengthening of interprofessional co-operation via education and training; and (5) initiating and advancing a societal discourse on overtreatment.

Clinical application of genomic high-throughput data: Infrastructural, ethical, legal and psychosocial aspects.

Genomic high-throughput technologies (GHTT) such as next-generation sequencing represent a fast and cost-effective tool toward a more comprehensive understanding of the molecular background of complex diseases. However, technological advances contrast with insufficient application in clinical practice. Thus, patients, physicians, and other professionals are faced with tough challenges that forestall the efficient and effective implementation. With the increasing application of genetic testing, it is of paramount importance that physicians and other professionals in healthcare recognize the restrictions and potential of GHTT, in order to understand and interpret the complex data in the context of health and disease. At the same time, the growing volume and complexity of data is forever increasing the need for sustainable infrastructure and state-of-the-art tools for efficient data management, including their analysis and integration. The large pool of sensitive information remains difficult to interpret and fundamental questions spanning from billing to legal, social, and ethical issues have still not been resolved. Here we summarize and discuss these obstacles in an interdisciplinary context and suggest ways to overcome them. Continuous discussion with clinicians, data managers, biostatisticians, systems medicine experts, ethicists, legal scholars, and patients illuminates the strengths, weakness, and current practices in the pipeline from biomaterial to sequencing and data management. This discussion also highlights the new, cross-disciplinary working collaborations to realize the wide-ranging challenges in clinical genomics including the exceptional demands placed on the staff preparing and presenting the data, as well as the question as to how to report the data and results to patients.

[Emergency care management of patients with cancer at the final stage of disease--seven cases]. / Notärztliche Betreuung von Tumorpatienten--Sieben Fälle aus der finalen Krankheitsphase.

The care of patients with cancer disease in the final stage amounts to 2.5% of all emergency-medical applications. This corresponded to the number of pediatric emergency cases. For this every emergency physician can be involved in the care of those patients. Emergency physicians may allow adapted treatment in the will or supposed will of the patient always. Therefore it is necessary to know special legal bearings of the case. We analysed seven emergency cases with patients in the final stage of their cancer disease retrospectively. For this we present seven different emergency cases with different regulatory framework for each emergency physician. The cases have shown seven possible care concepts of patients in the final stage of a cancer disease. All patients could be categorised as palliative ones. Nevertheless, the emergency physicians were alarmed by the patients' relatives because of needing professional help at the moment. The differences of the cases appeared in the regulatory framework. The seven cases have shown that different legal meanings could be important in emergency therapy of palliative patients.

Physician-Assisted Suicide and Euthanasia: Emerging Issues From a Global Perspective.

Medical professional societies have traditionally opposed physician-assisted suicide and euthanasia (PAS-E), but this opposition may be shifting. We present 5 reasons why physicians shouldn't be involved in PAS-E. 1. Slippery slopes: There is evidence that safeguards in the Netherlands and Belgium are ineffective and violated, including administering lethal drugs without patient consent, absence of terminal illness, untreated psychiatric diagnoses, and nonreporting; 2. Lack of self-determination: Psychological and social motives characterize requests for PAS-E more than physical symptoms or rational choices; many requests disappear with improved symptom control and psychological support; 3. Inadequate palliative care: Better palliative care makes most patients physically comfortable. Many individuals requesting PAS-E don't want to die but to escape their suffering. Adequate treatment for depression and pain decreases the desire for death; 4. Medical professionalism: PAS-E transgresses the inviolable rule that physicians heal and palliate suffering but never intentionally inflict death; 5. Differences between means and ends: Proeuthanasia advocates look to the ends (the patient's death) and say the ends justify the means; opponents disagree and believe that killing patients to relieve suffering is different from allowing natural death and is not acceptable. CONCLUSIONS: Physicians have a duty to eliminate pain and suffering, not the person with the pain and suffering. Solutions for suffering lie in improving palliative care and social conditions and addressing the reasons for PAS-E requests. They should not include changing medical practice to allow PAS-E.

Genomic information and a person's right not to know: A closer look at variations in hypothetical informational preferences in a German sample.

In clinical practice and in research, there is an ongoing debate on how to return incidental and secondary findings of genetic tests to patients and research participants. Previous investigations have found that most of the people most of the time are in favor of full disclosure of results. Yet, the option to reject disclosure, based on the so-called right not to know, can be valuable especially for some vulnerable subgroups of recipients. In the present study we investigated variations in informational preferences in the context of genetic testing in a large and diverse German sample. This survey examined health care professionals, patients, participants of genetic counseling sessions and members of the general population (N = 518). Survey participants were assessed regarding their openness to learning about findings under various hypothetical scenarios, as well as their attitudes about the doctor-patient-relationship in a disclosure situation and about informational transfer to third parties. While the majority of participants wanted to learn about their findings, the extent of support of disclosure varied with features of the hypothetical diagnostic scenarios (e.g., controllability of disease; abstract vs. concrete scenario description) and demographic characteristics of the subjects. For example, subjects with higher levels of education were more selective with regards to the kind of information they want to receive than those with lower levels of education. We discuss implications of these findings for the debate about the right not to know and for the clinical practice of informed consent procedures.

Ethical and legal framework and regulation for off-label use: European perspective.

For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.