Ethical challenges in primary care: a focus group study with general practitioners, nurses and informal caregivers.

BACKGROUND: General practitioners (GPs), nurses and informal caregivers are often jointly involved in healthcare situations in which ethical issues play an important role. OBJECTIVES: To describe ethical problems from the perspective of these three groups and to investigate whether there is a common experience of ethical issues in primary care. METHODS: We conducted six focus groups with general practitioners, nurses and informal caregivers in Germany. We asked the participants to describe at least one experience of ethical problem in detail and documented the findings by an illustration software that visualized and structured the discussion. We used thematic analysis to identify ethical problems and to develop categories of ethical issues. RESULTS: Problems reported barely overlapped. GPs had to do mainly with uncertainty about the scope and limits of their responsibility for patients. Nurses were concerned about bureaucratic and other barriers to professional care and about dual loyalty if they had to consider the conflicting interests of patients and family members. They often felt powerless and unable to act according to their professional standards. Informal caregivers reported problems that resulted from role strain and being both a family member and a caregiver. GPs, nurses and informal caregivers sometimes perceived the other parties as a source of ethical problems. CONCLUSIONS: All parties may benefit from ethics support services, a rarity in German primary care so far. Furthermore, nurses' self-confidence towards GPs, demanding patients and family members has to be strengthened. Informal caregivers, the most vulnerable group, need more attendance and tailored support.

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

BACKGROUND: After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear. METHODS: A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied. RESULTS: At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal by the Stasi. The Stasi was not particularly interested in medico-ethical questions. CONCLUSIONS: Clinical trials conducted during the GDR period were surveilled by the Stasi. It was their aim to monitor all people involved in the trials, including their Western contacts. Relevant medico-ethical questions like patient consent and safety with respect to the clinical trials were not the focus. Considering the significant number of conducted trials, only limited evidence exists of doctors having discussed them critically. The public was not officially informed about the trials.

Advance Directives as Support of Autonomy for Persons with Dementia? A Pilot Study among Persons with Dementia and Their Informal Caregivers.

BACKGROUND: Advance directives could be an important instrument to support a person's will once he/she is not able to consent anymore - if composed competently. A survey was conducted to identify the level of knowledge concerning possibilities and limits of advance directives. METHODS: The study was conducted as part of the Bavarian Dementia Survey (BayDem). Data were collected from January 2014 to December 2015 by structured face-to-face interviews. Study participants were persons with dementia and their informal caregivers (n = 74). RESULTS: In total, 66% reported having written an advance directive. Concerning the participants' knowledge about possibilities and limitations of advance directives, a lack of knowledge was noted about the possibility to revoke an advance directive. Furthermore, 70% of informal caregivers and 56% of persons with dementia were not aware of the possibility to include dementia-specific terms in the advance directive. CONCLUSION: It is necessary to optimize structures for public information and education concerning the topic of advance directives for persons with dementia.

[Medical Treatment of Newly Arrived Refugees in Erlangen: A Study of Drug Prescription Rates Focused on Psychotropic Drugs]. / Medizinische Versorgung von neu angekommenen Asylsuchenden in Erlangen: Eine Studie zum Medikamenteneinsatz mit besonderem Blick auf Psychopharmaka.

Background: In 2015 the number of refugees who sought asylum in Germany has increased dramatically. Therefore, the medical care for these refugees faces huge challenges. The treatment of mental illness of refugees is a particular difficult topic. Objective of this study is the acquisition of the outpatient prescriptions of drugs for newly arrived refugees in Erlangen, focused on psychotropic drugs. Methods: Evaluation of all outpatient prescribed drugs (n=1 137), which were prescribed between 10/01/2014 and 09/30/2015 for asylum seekers living in the refugee center in Erlangen, a branch of the "Central Admission Institution" ("ZAE") Zirndorf. Funding organization of this treatment is the City of Erlangen. Settlement documents of the City of Erlangen were used for the analysis. Results: The prescribed drugs cover the spectrum of acute primary care. Big parts of the prescription rates are antiinfectives (ATC-Code: J), medication for the respiratory system (ATC: R), as well as non-steroidal anti-inflammatory drug (NSAID's: ibuprofen, paracetamol, metamizole). The prescription of psychotropic drugs is relatively underrepresented.

The DSM 5 and the Istanbul Protocol: Diagnosis of psychological sequels of torture.

The Manual on Effective Investigation and Documentation of Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, commonly known as the Istanbul Protocol, is an interdisciplinary standard supported by, among others, the United Nations and the World Medical Association. It aims at aiding the fight against torture by giving clear guidelines to ensure better and more effective assessment of physical and psychological sequels. Mental health is a key aspect of diagnostical assessment and documentation due to the severe and frequently long-lasting impact of torture that often lasts longer than physical sequels. The inclusion of psychological aspects and a psychiatric diagnosis is to be treated as an important obligatory. Care must be taken to avoid common pitfalls. The new and substantial revisions in the frequently used but also criticised Diagnostical and Statistical Manual (DSM) reflect challenges and opportunities in a comprehensive approach to the documentation of torture.

Access to healthcare for undocumented migrants with communicable diseases in Germany: a quantitative study.

BACKGROUND: Migrants without residence permits are de facto excluded from access to healthcare in Germany. There is one exception in relevant legislation: in the case of sexually transmitted infections and tuberculosis, the legislator has instructed the local Public Health Authorities to offer free and anonymous counseling, testing and, if necessary, treatment in case of apparent need. Furthermore, recommended vaccinations may be carried out free of charge. This study intends to comprehensively capture the services for undocumented migrants at Public Health Authorities in Germany. METHODS: An e-mail survey of all Local Public Health Authorities (n = 384) in Germany was carried out between January and March 2011 using a standardized questionnaire. RESULTS: One hundred thirty-nine of 384 targeted local Health Authorities completed the questionnaire (36.2%), of which approximately a quarter (n = 34) reported interaction with 'illegal' immigrants. Twenty-give authorities (18.4%) gave the indication to carry out treatment. This outpatient treatment option is mostly limited to patients afflicted with sexually transmitted infections with the distinct exception of human immunodeficiency virus/acquired immune deficiency syndrome. CONCLUSIONS: The study highlights the gap between legislation and the reality of restricted access to medical services for undocumented migrants in Germany. It underlines the need of increased financial and human resources in Public Health Authorities and, overall, the simplification of national legislation to assure the right to healthcare.

Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain.

Western pharmaceutical companies conducted clinical trials in the Eastern Bloc during the Cold War. Recently, media reports about alleged human experimentation provoked a wave of indignation. However, a scientific and objective account of these trials is lacking. The aim of this study was to describe and evaluate the clinical trials performed in the German Democratic Republic (GDR) based on archival material from the health system and the secret service. We found documents relating to 220 trials involving more than 14,000 patients and 68 Western companies. However, no record of patient information forms or systematic documentation regarding the provision of patient consent was discovered. There was no evidence to suggest that the trials systematically and intentionally damaged patients. The trials were conducted without the knowledge of the public. GDR legislation stipulated that patients must consent to the trials, but no evidence was found to suggest that patients were systematically informed. Documents suggest that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved. The GDR agreed to the trials due to impending bankruptcy and Western pharmaceutical companies capitalised on this situation.

Clinical ethics and patient advocacy: the power of communication in health care.

In recent years, the rights of patients have assumed a more pivotal role in international discussion. Stricter laws on the protection of patients place greater priority on the perspective and the status of patients. The purpose of this study is to emphasize ethical aspects in communication, the role of patient advocates as contacts for the concerns and suggestions of patients, and how many problems of ethics disappear when communication is highlighted. We reviewed 680 documented cases of consultation in a 10-year period of patient advocates' activity at a big German university hospital with 1,300 beds. On the basis of this extensive material, the article will focus on the intersection of the advocate's work with the problems of patients in hospitals. Deficits in the level of communication between health care professionals and patients were frequently uncovered. Patients primarily complain about the lack of dialogue and empathy. Middle-aged patients consulted the patients' advocate disproportionately more often. Measured against this baseline, the group of 65 and older complained less frequently. Besides complaints the advocate was asked in more than one-third of all cases for information about medical matters, hospital regulations or administrative problems. Patients obviously see the advocate as a well-connected and ideally unbiased contact person for uncertainties concerning their malady or a potential stay in hospital. Those seeking help often set hope in the information given by the voluntary patient representative. It should be highly recommended for every German hospital to establish the position of a patient advocate. Furthermore, patients can profit from regular exchange between the advocate and the Ethics Committee, also, to help ensure that their rights are taken into account and implemented in an ethically desirable context.

[Werner Leibbrand, Annemarie Wettley and controversies on "euthanasia" the background of medico-historical and ethical debates in the Post World War II era]. / Werner Leibbrand, Annemarie Wettley und Kontroversen um "Euthanasie". Die Hintergründe medizinhistorisch-ethischer Debatten der Nachkriegszeit.

Psychiatrists and medical historians Werner Leibbrand (1896 - 1974) and Annemarie Wettley (1913 - 1996) are amongst the most striking figures in the field of history of medicine. Leibbrand was appointed director of the "Heil- und Pflegeanstalt" in Erlangen shortly after the war. Fuelled by his own experiences of suppression and persecution during the Nazi era he promised to unearth the crimes and atrocities which had happened under watch of the Nazi regime. He was joined by Annemarie Wettley, who worked as a physician at the hospital and had developed an increasing interest in the history of medicine. In 1946 they published "Um die Menschenrechte der Geisteskranken" ("Human Rights of the Mentally Ill") about the "euthanasia" campaign of the Nazi regime. Although a number of substantial works followed, Leibbrand and Wettley failed to inform in more depth on crimes and atrocities, for instance killings of patients and forced malnutrition. Doubts and charges against Wettley regarding her role in dietary programmes at the Erlangen hospital and against Leibbrand regarding special expert's reports--both had a short-term arrest warrant--might have contributed to stagnation in their efforts. In 1953 Leibbrand accepted the offer of a chair at the University in Munich, Wettley followed and habilitated in history of medicine; in the year 1962 they married. Contacts and exchange amongst medico-historical experts shed light on developments during the post-war era; still, a critical and fundamental review of the crimes within the medical system of the Nazi regime did not take place during this time.

Ethics consultation and empathy : finding the balance in clinical settings.

There is no doubt that emotions have an important effect on practices of moral reasoning such as clinical ethics consultation. Empathy is not only a basic human emotion but also an important and learnable skill for health care professionals. A basic amount of empathy is essential both in patient care and in clinical ethics consultation. This article debates the "adequate dose" of empathy in ethics consultations in clinical settings and tries to identify possible situations within the process of consultation in which this crucial feeling is at risk.

Human rights from the Nuremberg Doctors Trial to the Geneva Declaration. Persons and institutions in medical ethics and history.

The "Universal Declaration of Human Rights" and the "Geneva Declaration" by the World Medical Association, both in 1948, were preceded by the foundation of the United Nations in New York (1945), the World Medical Association in London (1946) and the World Health Organization in Geneva (1948). After the end of World War II the community of nations strove to achieve and sustain their primary goals of peace and security, as well as their basic premise, namely the health of human beings. All these associations were well aware of the crimes by medicine, in particular by the accused Nazi physicians at the Nuremberg Doctors Trial (1946/47, sentence: August 1947). During the first conference of the World Medical Association (September 1947) issues of medical ethics played a major role: and a new document was drafted concerning the values of the medical profession. After the catastrophe of the War and the criminal activities of scientists, the late 1940s saw increased scrutiny paid to fundamental questions of human rights and medical ethics, which are still highly relevant for today's medicine and morality. The article focuses on the development of medical ethics and human rights reflected in the statement of important persons, codes and institutions in the field.

Documentation of torture and the Istanbul Protocol: applied medical ethics.

The so-called Istanbul Protocol, a Manual on the Effective Investigation and Documentation of Torture and other Cruel, Inhumane or Degrading Treatment or Punishment was adopted by the United Nations soon after its completion in 1999 and since then has become an acknowledged standard for documenting cases of alleged torture and other forms of severe maltreatment. In 2009 the "Forum for medicine and human rights" at the Medical Faculty at the University Erlangen-Nuremburg has provided the first German edition of this manual. The article traces back the development of the protocol taking into account the general background as well as the factual occasion of its initiation. The main ethical and legal principles of the manual are introduced as well as the projects for implementing the rules provided in the protocol that have been carried out so far. From this the urgent need for implementation of the Istanbul Protocol guidelines also in Europe and in German-speaking countries and here not exclusively but especially within asylum procedures becomes clear.

[History as politics. Medical historians in Berlin and Graz serving the NS-State]. / Fachgeschichte als Politikum: Medizinhistoriker in Berlin und Graz in Diensten des NS-Staates.

History of medicine played an important part in the ideology and policy of the Third Reich. The Nazi Party and the "Schutzstaffel" (SS) tried to instrumentalize historical knowledge to justify their ideology and medical ethics. The academic discipline of the history of medicine saw a revival during the Nazi period and, especially, during the Second World War. Important medical historians were eager to contribute to a symbiosis between the State and their field. The close relationship between the history of medicine and the Nazi regime was particularly apparent at Paul Diepgen's Department for the History of Medicine and Natural Sciences at the University of Berlin. Diepgen, apart from his own collaboration with the Nazi regime, was the teacher of Bernward J. Gottlieb who became the leading medical historian of the SS and Director of the new "SS-Institute for the History of Medicine" in Berlin in 1941. Gottlieb's institute moved in 1943 to the "SS-Academy" in Graz to train future SS-physicians in the history of medicine. The history of medicine was of great relevance also for certain members of the Nazi elite. They included Heinrich Himmler, the head of the SS, who ensured that Gottlieb would become Diepgen's successor in 1945 for the chair of medical history at the University of Berlin. Hitler was asked to intervene in the appointment process given the political importance of the field and, in particular, the professorship being located in Berlin. The SS was able to exercise, by this time, a decisive influence on the field of the history of medicine. Only the collapse of the Third Reich prevented the traditional discipline from becoming a "science" to legitimize the Nazi System and the SS. The aim of this paper is to examine the role of the field of the history of medicine and of its key institutions and personalities during the Third Reich.

["Eternal physicianship" or "new medical ethics" 1939-1945? Hippocrates and historians in the service of war]. / "Ewiges Arzttum" oder "neue Medizinethik" 1939-1945? Hippokrates und Historiker im Dienst des Kreges.

What changes, if any, came with the so-called "new medical ethics" that was propagated during the Nazi period and the war of 1939-1945? This article analyses the context of the publication series "Ewiges Arzttum" ("eternal physicianship"), which was edited during World War II. The first volume--"Hippocrates"--included an introduction by the "Reichsführer-SS", Heinrich Himmler, and was edited by the "Reichsarzt-SS", Ernst Grawitz. B. J. Gottlieb, the medical historian who arranged the excerpts from Hippocratic texts, later headed an SS-Institute for the History of Medicine in Graz. Gottlieb was a pupil of Paul Diepgen, the head of the large Department for the History of Medicine and Natural Sciences at the University of Berlin. What were the goals of historians under National Socialism when they constructed continuities between the ethics of ancient times and the Nazi ethos? How did the moral points of view change under political pressure and in the circumstances of war? The series "Ewiges Arzttum", its context, and the correspondence between the persons involved are striking examples of the instrumentalisation of history for other purposes, even for "total war".