Variations of sex development: The first German interdisciplinary consensus paper.

INTRODUCTION: The term variations of sex development subsumes a large number of congenital conditions including chromosomal mosaics and variations of chromosomal, gonadal, and phenotypic sex. A situation of this nature may cause severe distress to both, parents and affected persons. One of the reasons for this is the binary form of gender classification in the society. In the past, because of a fear of possible stigmatization and an inability to cope with complex situations, it has been medical policy and practice for newborns to undergo early, mostly 'feminizing' elective surgery with the aim of achieving an outer genital appearance that is unambiguously male or female. Protests by advocacy groups for the most part as well as the results of outcome studies have shown that the development of affected persons may be very different to what has been expected and often does not result in the intended clear female or male gender identity as had been intended. It, therefore, seemed a matter of urgency to implement this new awareness as well as the ethical and personal human rights perspectives in the recommendations for the medical and psychosocial management of diverse sex development (DSD) in the future. STUDY DESIGN: In 2012, an interdisciplinary group of German academics engaged in the field of DSD decided to work on a consensus paper for this topic. It involved the participation of all faculties and non-scientific groups dealing with DSD, in particular advocacy and service-user groups. In a structured consensus, process recommendations were developed based on scientific literature as well as personal experiences of clinicians and affected individuals. RESULTS: Finally, 37 recommendations were agreed on. The strength of consensus is reflected in the degree of agreement as expressed in percentages. CONCLUSION: The introduction of the consensus paper reflects on the emerging paradigm shift and the necessity for a more open view of gender within society. The paper is intended to aid the performance of appropriate diagnostics in DSD-affected newborns and especially to help parents and affected persons cope with the biological and social consequences of DSD. With regard to medical or surgical therapy, it gives information about the most recent treatment trends.

[Standards for treatment in forensic committment according to § 63 and § 64 of the German criminal code : Interdisciplinary task force of the DGPPN]. / Standards für die Behandlung im Maßregelvollzug nach §§ 63 und 64 StGB : Interdisziplinäre Task-Force der DGPPN.

People who have been convicted of a crime due to a severe mental disorder and continue to be dangerous as a result of this disorder may be placed in a forensic psychiatric facility for improvement and safeguarding according to § 63 and § 64 of the German Criminal Code (StGB). In Germany, approximately 9000 patients are treated in clinics for forensic psychiatry and psychotherapy on the basis of § 63 of the StGB and in withdrawal centers on the basis of § 64 StGB. The laws for treatment of patients in forensic commitment are passed by the individual States, with the result that even the basic conditions differ in the individual States. While minimum requirements have already been published for the preparation of expert opinions on liability and legal prognosis, consensus standards for the treatment in forensic psychiatry have not yet been published. Against this background, in 2014 the German Society for Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) commissioned an interdisciplinary task force to develop professional standards for treatment in forensic psychiatry. Legal, ethical, structural, therapeutic and prognostic standards for forensic psychiatric treatment should be described according to the current state of science. After 3 years of work the results of the interdisciplinary working group were presented in early 2017 and approved by the board of the DGPPN. The standards for the treatment in the forensic psychiatric commitment aim to initiate a discussion in order to standardize the treatment conditions and to establish evidence-based recommendations.

[Coercive procedures in forensic psychiatry : Current treatment practice in forensic psychiatric hospitals from a medical ethics perspective]. / Zwangsmaßnahmen in der forensischen Psychiatrie : Aktuelle Behandlungspraxis im Maßregelvollzug aus medizinethischer Perspektive.

BACKGROUND: In 2011 the legal foundations of coercive treatment in German forensic psychiatric clinics were declared to be unconstitutional. In the present study we analyzed the frequency of coercive procedures in forensic psychiatric hospitals before and after 2011, the consequences for medical care as well as the ethical assessments by attending chief physicians. METHODS: By a questionnaire-based survey of views of attending chief physicians in forensic psychiatric clinics in 2013, data on the current state of patient care were collected and analyzed from an ethical perspective. These were compared with treatment data from a large forensic psychiatric clinic collected over the period 2007-2013. RESULTS: Even after 2011 coercive forms of treatment were applied in forensic psychiatric hospitals. In practice, there is a high degree of legal uncertainty regarding the limits of coercive treatment. Of all patients treated in forensic psychiatric clinics in 2012, on average 13 % had been in isolation at least once, approximately 3 % had been treated under fixation at least once and 2.2 % had been subjected to coercive medical treatment at least once. CONCLUSION: From an ethical perspective an open debate about the practice of coercive treatment is urgently required. Legal regulations, ethical guidelines and treatment standards have to be developed for the special situation of patient care in forensic psychiatric hospitals.

Ethical guidelines for the clinical management of intersex.

The clinical management of intersex has undergone a significant change in values. Whereas in former times, benevolent medical paternalism was the rule, today, the patient's right to respect for dignity and self-determination is given priority. This paper discusses ethical considerations shaping the modern therapeutic management of intersex conditions that do not entail acute health risks. It concludes with basic ethical guidelines for clinical practice.

[Ethics and diagnosis related groups]. / Ethik und Fallpauschalen. Welche Veränderungen in der Patientenversorgung sind zu erwarten?

At the turn of the year 2003/2004 a change took place in the in-patient sector of the German public health care system from the former daily-rate-based reimbursement of medical services to a reimbursement in accordance with diagnosis related groups (DRGs). At the same time, there are indications for a paradigm change in the allocation of medical services: away from the even provision of medical care across all country's municipalities towards a concentration in specialized medical centres - with uncertain ethical implications. On one hand, one hopes to cut costs in the in-patient area. On the other hand, it is questionable, whether cutting costs still allows an adequate treatment of multimorbid, chronically ill patients. The new system likely favours the active, autonomously deciding patient, who is capable of using additional information from the planned quality reports to obtain the best possible medical services. But the new system could create a disadvantage for the less informed patient groups, especially those who don't have easy access to such information. It is not our intention to idealise the German health care system before the invention of diagnosis related groups. Based on a survey of studies from the U.S., the article assesses consequences of such a system and relates them to ethical considerations.

Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?

OBJECTIVES: Clinical trials in humans in Germany-as in many other countries-must be approved by local research ethics committees (RECs). The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors' purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk. DESIGN: In a questionnaire, REC chairpersons had to evaluate five different scenarios with (in parts) non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved. METHODS: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios. RESULTS: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than "minimal", the chairpersons' decisions differ widely. CONCLUSION: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary.

[Patient self-determination - the beneficiaries of medicine and their rights]. / Selbstbestimmte Patienten? - Die Nutzniesser der Medizin und ihre Rechte

Respect for patient autonomy is one of the major ethical goals of modern medicine. Therefore, it is important to analyse whether the organisational structure of the German health care system impedes the realisation of patient self-determination. It will be shown by means of historical and ethical analysis that the nature of the doctor-patient relationship as well as other factors in the organisation of modern medicine systematically undermine patient autonomy. If individual responsibility in the health care setting is to be strengthened, patients' influence on public health decision-making processes, too, has to be advanced. The paper shows from a patient perspective where this could be the case.

[Brain death and intensive care medicine. The cultural history of a medical concept]. / Hirntod und Intensivmedizin. Zur Kulturgeschichte eines medizinischen Konzepts.

The paper focuses on the cultural history of brain death in Germany in the second half of the 20th century. It analyzes scientific and public discourses on the relevance of brain death and the importance of medical innovations in intensive care medicine. The paper examines how the public reacted when heart transplantation led to an urgent need for a new definition of death. It will be shown how the concept of brain death was accepted by the public, introduced into clinical routine, and implemented through medical and legal policies. Finally, it will be analyzed why the public consensus on brain death was definitely questioned in the last ten years. An understanding of the use of the concept of brain death by scientists, lawyers, theologians, and the public during the last three decades may help to shed light on the social role of science in modern and late-modern societies.

The significance of prognosis for a theory of medical practice.

A typical problem of modern medicine results from the gap between scientific knowledge and its application in individual cases. Whereas scientific knowledge is generalized and impersonal information, medical practice takes place under conditions which are singular, individual and irreversible. The paper examines whether prognosis is able to bridge this gap or "hiatus theoreticus". It is shown that diagnosis of a single case always relies on prognostic considerations. The individual prognosis (as distinguished from the nosologic prognosis of a certain disease) enables doctors to apply scientific knowledge and practice according to the actual situation, the history and personal preferences of the patient. Prognosis--not diagnosis--therefore legitimizes medical interference. A methodology of individual prognosis as the basis for a theory of practice is discussed.

[Can psycho-education of chronic schizophrenic patients have a short-term effect on drug-related attitude and behavior?]. / Kann Psychoedukation bei chronisch schizophrenen Patienten kurzfristig medikationsbezogene Einstellungen und Verhaltensweisen beeinflussen?

Within a controlled intervention study with schizophrenic outpatients we investigated the question of whether regular attendance at psychoeducational training for medication management has an influence on patients' illness-related behavior. The patients in the treatment group show better outcome of compliance and some treatment-related attitudes, though without statistical significance. Despite extensive information they are no more content with their knowledge of drugs than the control group, but more aware of problems, i.e. more cautious in medication co-determination.

[Ethics curriculum for medical students: theory or general practice?]. / Ethikunterricht für Medizinstudenten: Theorie oder Praxis?

In a three-year project supported by the "Stifterverband für die Deutsche Wissenschaft" the Institute for the History of Medicine, University of Erlangen-Nürnberg, Germany, evaluates methods of teaching medical ethics to medical students. Using mainly case studies during a one-week intensive course students learn how to identify ethical conflicts and to find responsible solutions. Ethical problems arising from students' involvement in patients' care are also considered. As a result of this specific aspect of teaching medical ethics an ethical code for medical students was developed.

[Uprising in the faculty. On the rhetorical function of 'therapeutic nihilism' in traditional medicine in Vienna]. / Der Aufstand in der Fakultät. Zur rhetorischen Funktion des 'therapeutischen Nihilismus' im vormärzlichen Wien.

It has been a long tradition to quote from Joseph Dietl's 'manifesto' of therapeutic nihilism from 1845 to illustrate the perils of medical extremism. But Dietl's claim for medicine as a natural science cannot fully be understood without considering the social and political circumstances the developing New Vienna School had to face. The professionalization of Viennese academic medicine was opposed by the forces of restaurative absolutism and, in particular, the traditional preponderance of medical practitioners who played a major role in the medical faculty.