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1.
Artigo em Alemão | MEDLINE | ID: mdl-31965193

RESUMO

Digital technologies in public health have the potential to improve health promotion and disease prevention by the efficient registration, storage, and processing of large amounts of health data. Digital public health also raises - like other technological developments - several ethical issues, which are discussed in this article.A fundamental question in the ethical evaluation of digital public health interventions concerns the goal of the intervention: An intervention should serve the established goals of public health and not financial interests, to realize potential health benefits for the population. In addition, equity issues are especially relevant, because digital public health may reduce or increase health inequalities in the population. Furthermore, the protection of privacy and potentially sensitive health data are relevant. As digital public health applications vary considerably, each application has to be assessed individually regarding its ethical implications. This article therefore presents a normative framework and a methodological approach for the ethical evaluation of digital public health applications. By developing ethically justified recommendations for the design and use of digital public health applications, the ethical evaluation can contribute to an ethically justified practice of digital public health.


Assuntos
Assistência à Saúde/métodos , Saúde Pública/ética , Alemanha , Promoção da Saúde , Humanos , Princípios Morais , Telemedicina/ética
2.
Artigo em Alemão | MEDLINE | ID: mdl-31773175

RESUMO

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.

3.
Health Policy ; 123(10): 1004-1010, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31492458

RESUMO

Genetic relatives of hereditary colorectal cancer patients with Lynch syndrome (LS) are at risk of cancer. Testing both colorectal cancer patients and relatives of mutation carriers for LS allows targeted prevention. However, this could mean disclosing sensitive health data to family members. In light of potential trade-offs between cost-effectiveness and patient privacy, this study investigates the implications of increasing test uptake in Germany. Out of 22 screening strategies for LS, the non-dominated and current German strategies were assessed from the perspective of the statutory health insurance. Life years gained by increased prevention were estimated with Markov models. The effects and implications of different test uptake rates in index patients and their relatives were investigated by scenario analysis. Privacy limitations could yield health gains of up to 2500 undiscounted life years for first-degree relatives of index patients and substantially improve cost-effectiveness. However, this approach may contradict the right to informational self-determination. This study demonstrates the effect higher LS test uptakes could have on the lives and rights of colorectal cancer patients and their relatives. It shows potential conflicts between the efficient use of health care resources on the one hand and reasonable consideration of patient autonomy on the other.

4.
Int J Technol Assess Health Care ; 35(4): 280-290, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31337450

RESUMO

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.

6.
Dtsch Med Wochenschr ; 144(14): 990-996, 2019 07.
Artigo em Alemão | MEDLINE | ID: mdl-31096279

RESUMO

The AWMF and its medical societies perceive an increasing dominance of economic targets in the hospital health care sector, leading to impairment of patient care. While resource use in health care should be appropriate, efficient and fairly allocated, "economization" creates a burdensome situation for physicians, nurses and other health care professionals.The AMWF and the medical societies studied causes and developed measures for a scientific, patient-centred and resource-conscious medical care. Disincentives due to the remuneration system, number and equipment of hospitals resp. specialist departments and their basic funding need to be overcome. Proposed actions relate to the patient-doctor-level, the management level of hospitals and the level of planning and financing hospitals including compensation of hospital care. To place patients and their health in the forefront again, joint efforts of all stakeholders in health care are needed.


Assuntos
Economia Hospitalar , Administração Hospitalar , Assistência Centrada no Paciente/economia , Sociedades Médicas/organização & administração , Humanos
7.
Med Health Care Philos ; 22(4): 623-630, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31011945

RESUMO

Mhealth technology is mushrooming world-wide and, in a variety of forms, reaches increasing numbers of users in ever-widening contexts and virtually independent from standard medical evidence assessment. Yet, debate on the broader societal impact including in particular mapping and classification of ethical issues raised has been limited. This article, as part of an ongoing empirically informed ethical research project, provides an overview of ethical issues of mhealth applications with a specific focus on implications on autonomy as a key notion in the debate. A multi-stage model of references to the potential of mhealth use for strengthening some or other form of self-determination will be proposed as a descriptive tool. It illustrates an assumed continuum of enhanced autonomy via mhealth broadly conceived: from patient to user autonomy, to improved health literacy, and finally to the vision of supra-individual empowerment and democratised, participatory health and medicine as a whole. On closer examination, however, these references are frequently ambivalent or vague, perpetuating the at times uncritical use of established autonomy concepts in medical ethics. The article suggests zooming in on the range of autonomy-related aspects against the backdrop of digital innovation and datafied health more generally, and on this basis add to existing frameworks for the ethical evaluation of mhealth more specifically.

8.
Ann Anat ; 223: 108-118, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30797974

RESUMO

The system of anatomical body procurement had to be reorganized in Germany after the end of the Second World War. At that time, the country had been split up and, in its Western zones of occupation, which eventually would form the Federal Republic of Germany, a democratic form of government was reintroduced. While political and economic conditions were improving, well-known obstacles of sufficient body supply turned out to be increasingly complicated to overcome. This development led to the dissolution of the traditional system of body procurement which had, during the centuries and political systems, always depended on the state. From the 1960s onwards, it became solely reliant on willed body donations. The article deals with the question how this fundamental change came to be, and which motives and arguments on the side of the anatomists as well as the administration were crucial for the final decision of limiting body procurement to willed donations. Using the example of the anatomical institute of Munich University, it is possible not only to highlight the political process of dealing with the problem of anatomical body procurement after 1945. Additionally, the quantitative changes in body supply resulting from those developments will be presented and analyzed. Thereby it can be displayed how the dissolution of the traditional system meant the solution of its inherent problems.


Assuntos
Anatomia/educação , Anatomia/história , Cadáver , Anatomia/legislação & jurisprudência , Dissecação/educação , Dissecação/história , Dissecação/legislação & jurisprudência , Alemanha Ocidental , História do Século XX , Humanos , Faculdades de Medicina/história , Faculdades de Medicina/legislação & jurisprudência
9.
Gesundheitswesen ; 2019 Feb 18.
Artigo em Alemão | MEDLINE | ID: mdl-30776832

RESUMO

AIMS: In the case of acute brain injury, decision-making uncertainties can arise when both an advance decision to refuse treatment and a prior consent to post-mortem organ donation are present. It is yet unknown how the persons concerned view this potential conflict. The present study aims to investigate how frequent this situation is, whether the persons concerned are aware of the potential conflict and what they would prioritize. METHODS: Semi-quantitative cross-sectional survey of senior citizens of a metropolitan region in Germany using a literature-based questionnaire. RESULTS: A total of 236 senior citizens participated in the survey, amounting to 52% of those invited. While 54% of the participants reported to have written advance directives, 46% had expressed their consent to post-mortem organ donation in written or oral form. Altogether, 29% of all participants had issued both types of written documents. The consent to organ donation correlated significantly with the presence of an advance directive. Only 47% of the advance directives contained, according to their authors, statements about organ donation. Dying outside of intensive care was the priority for 51%, while 17% favored donating their organs. About half of the participants accepted transient intensive care measures in the case of presumed or expected brain death, but only a fourth also accepted cardiopulmonary resuscitation in those situations. Knowledge about brain death was scant and the attitudes towards it were rather critical. CONCLUSION: The coincidence of advance directives and organ donation consent is not uncommon in senior citizens and could contribute to low organ donation rates. The heterogeneous attitudes of the surveyed persons as well as their poor knowledge about brain death and the potential conflict studied here underscore the necessity of a high-quality advance care planning process.

10.
Syst Rev ; 7(1): 79, 2018 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-29792224

RESUMO

BACKGROUND: Conducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues. The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs. METHODS: We will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way. DISCUSSION: Our analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.


Assuntos
Promoção da Saúde , Saúde Pública , Projetos de Pesquisa , Avaliação da Tecnologia Biomédica/métodos , Humanos
12.
PLoS One ; 13(2): e0193010, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29447259

RESUMO

Hospitals in Germany employ increasing numbers of foreign-born and foreign-trained (FB&FT) physicians. Studies have investigated how FB&FT physicians experience their professional integration into the German healthcare system, however, the perspectives of stakeholders working with and shaping the work experiences of FB&FT physicians in German hospitals have so far been neglected. This study explores relevant stakeholders' opinions and attitudes towards FB&FT physicians-which likely influence how these physicians settle in-and how these opinions were formed. We conducted a qualitative interview study with 25 stakeholders working in hospitals or in health policy development. The interviews were analyzed within a constructivist research paradigm using methods derived from Grounded Theory (situational analysis as well as open, axial and selective coding). We found that stakeholders tended to focus on problems in FB&FT physicians' work performance. Participants criticized FB&FT physicians' work for deviating from presumably shared professional standards (skill or knowledge and behavioral standards). The professional standards invoked to justify problem-focused statements comprised the definition of an ideal behavior, attitude or ability and a tolerance range that was adapted in a dynamic process. Behavior falling outside the tolerance range was criticized as unacceptable, requiring action to prevent similar deviations in the future. Furthermore, we derived three strategies (minimization, homogenization and quality management) proposed by participants to manage deviations from assumed professional standards by FB&FT physicians. We critically reflect on the social processes of evaluation and problematization and question the legitimacy of professional standards invoked. We also discuss discriminatory tendencies visible in evaluative statements of some participants as well as in some of the strategies proposed. We suggest it will be key to develop and implement better support strategies for FB&FT physicians while also addressing problematic attitudes within the receiving system to further professional integration.


Assuntos
Médicos Graduados Estrangeiros , Médicos , Profissionalismo , Atitude do Pessoal de Saúde , Competência Clínica , Alemanha , Política de Saúde , Humanos , Entrevistas como Assunto , Papel do Médico , Preconceito , Pesquisa Qualitativa
13.
Artigo em Alemão | MEDLINE | ID: mdl-29320792

RESUMO

Like in other countries, advance care planning (ACP) is currently being implemented in Germany as a new concept to realise valid and effective advance directives. This concept comprises processes to explore and document individual preferences for future treatment, and to honour them at a time when the person is incapacitated. ACP aims to ensure that patients will be treated according to their preferences when they are no longer capable due to acute health crises or chronic diseases. This paper gives an overview of the concept of ACP with a focus on relevant issues for emergency and intensive care medicine.


Assuntos
Planejamento Antecipado de Cuidados/tendências , Planejamento Antecipado de Cuidados/legislação & jurisprudência , Diretivas Antecipadas , Documentação , Serviços Médicos de Emergência , Alemanha , Humanos , Testamentos Quanto à Vida
15.
Geburtshilfe Frauenheilkd ; 77(9): 984-992, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28959062

RESUMO

INTRODUCTION: In recent years, the hopes and expectations associated with so-called individualized medicine have been the subject of intense debate as has the medical potential of this approach. Questions about the uses of gene expression analyses for decisions on adjuvant systemic treatment options for patients with breast cancer have played a prominent role in this debate. There are a number of empirical studies on the effect of gene expression tests on the therapy decisions of physicians and the potentially conflicted decisions for patients. Very little attention has been paid to how patients perceive such approaches, the extent to which they feel included in the therapy decision, and the expectations they associate with such an approach. MATERIAL AND METHODS: Using qualitative explorative interviews, the study looked at how well patients with breast cancer understood the individualized treatment approaches and examined patients' experiences and expectations with regard to gene expression analyses. The sample consisted of 8 patients who were diagnosed with primary hormone receptor-positive, HER2-negative breast cancer between 2013 and 2014 and who underwent gene expression analyses as part of their adjuvant therapy planning. RESULTS: Patients were found to have a quite realistic view of the benefits of gene expression analyses, although it also became clear that the treatment could also raise false hopes. The statements by the interviewed women also illustrated the necessity of continuing to explore the possibilities and limits to joint decision-making in such complex medical contexts as individualized molecular genomic medicine. And finally, the interviews reflected the hope for individualized treatment in the broadest sense of the word. CONCLUSION: The results of the study highlight the challenge of taking psychosocial aspects of medical treatment sufficiently into consideration, given the ever increasing options for molecular genomic individualization.

16.
Breast Care (Basel) ; 12(2): 81-85, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28559763

RESUMO

Spiraling costs of cancer treatments have become a major concern for the payers in the health care system and for individual patients suffering from the cancer drugs' financial toxicity. This article discusses possible solutions from an ethical perspective. First, it gives some orientation about what constitutes a fair price for innovative anticancer agents. While a definitive answer remains difficult, there are good reasons to enter into price negotiations with the pharmaceutical companies to align the price with the R&D costs and the added value of the product. Information about the drug's cost-effectiveness should be available, a fixed threshold, however, seems ethically problematic. Rather, a 'signal cost-effectiveness threshold' should indicate when the drug price requires special justification. Further strategies include an improved benefit assessment after market authorization by independent publicly financed studies, which will provide a valid basis for price negotiations and clinical decision-making at the micro level. Last but not least, cancer treatments should be tailored not only to the biology of the tumor but also to the preferences of the patient. Primarily mandated by the respect for autonomy, promoting patient-centered care has the potential to improve quality of care and enable a wise use of scarce health care resources.

18.
BMC Med Ethics ; 18(1): 21, 2017 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-28253882

RESUMO

BACKGROUND: Recent findings suggest that medical students' moral competence decreases throughout medical school. This pilot study gives preliminary insights into the effects of two educational interventions in ethics classes on moral competence among medical students in Munich, Germany. METHODS: Between 2012 and 2013, medical students were tested using Lind's Moral Competence Test (MCT) prior to and after completing different ethics classes. The experimental group (EG, N = 76) participated in principle-based structured case discussions (PBSCDs) and was compared with a control group with theory-based case discussions (TBCDs) (CG, N = 55). The pre/post C-scores were compared using a Wilcoxon Test, ANOVA and effect-size calculation. RESULTS: The C-score improved by around 3.2 C-points in the EG, and by 0.2 C-points in the CG. The mean C-score difference was not statistically significant for the EG (P = 0.14) or between the two groups (P = 0.34). There was no statistical significance for the teachers' influence (P = 0.54) on C-score. In both groups, students with below-average (M = 29.1) C-scores improved and students with above-average C-scores regressed. The increase of the C-Index was greater in the EG than in the CG. The absolute effect-size of the EG compared with the CG was 3.0 C-points, indicating a relevant effect. CONCLUSION: Teaching ethics with PBSCDs did not provide a statistically significant influence on students' moral competence, compared with TBCDs. Yet, the effect size suggests that PBSCDs may improve moral competence among medical students more effectively. Further research with larger and completely randomized samples is needed to gain definite explanations for the results.


Assuntos
Educação de Graduação em Medicina , Ética Médica/educação , Desenvolvimento Moral , Ética Baseada em Princípios , Aprendizagem Baseada em Problemas , Competência Profissional , Estudantes de Medicina , Adulto , Currículo , Avaliação Educacional , Teoria Ética , Feminino , Alemanha , Humanos , Masculino , Princípios Morais , Projetos Piloto , Resolução de Problemas , Inquéritos e Questionários , Adulto Jovem
19.
Ann Anat ; 211: 2-12, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28161481

RESUMO

During the reign of National Socialism (NS) anatomical institutes regularly received bodies of executed prisoners in steadily increasing numbers. After 1939, the execution site at Stadelheim prison in Munich supplied not only Munich anatomy but also the institutes in Erlangen, Innsbruck and Würzburg. Due to the disappearance of the Munich body journals, the exact dimension and procedure of body procurement from Stadelheim remained unknown for 70 years. After consultation of a wide range of sources, including rediscovered fragments of the body journals, it is now possible to give an almost comprehensive account of the developments. This article deals with the attempts at recovering information on body procurement from Stadelheim prison during the NS period, which already indicated the significance of Munich anatomy in organizing the distribution of bodies. Thereafter, it addresses the number and distinct groups of Stadelheim prisoners, executed and delivered to the four anatomical institutes, the differences in the handling of their bodies, and the extent to which in particular Munich anatomy profited from the massive increase in executions. Finally, it unveils the role of the Munich Anatomical Institute in distributing those bodies among the anatomies during the Second World War, making it not only the main beneficiary but also the interim center of this process.


Assuntos
Academias e Institutos/história , Anatomia/história , Pena de Morte/história , Experimentação Humana/história , Socialismo Nacional/história , Prisioneiros/história , Prisioneiros/estatística & dados numéricos , Cadáver , Pena de Morte/estatística & dados numéricos , Feminino , Alemanha , História do Século XX , Experimentação Humana/estatística & dados numéricos , Humanos , Masculino
20.
Hum Resour Health ; 14(1): 57, 2016 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-27662831

RESUMO

BACKGROUND: With Germany facing a shortage of doctors, hospitals have been increasingly recruiting physicians from abroad. Studies in other countries have shown that migrant physicians experience various difficulties in their work, which might impact the quality of patient care, physician job satisfaction, and, accordingly, retention. The experiences of migrant doctors in Germany have not been systematically studied so far and will likely differ from experiences migrant physicians make in other contexts. A thorough understanding of challenges faced by this group, however, is needed to develop adequate support structures-as required by the WHO Global Code of Practice on the International Recruitment of Health Personnel. METHODS: A qualitative study was conducted to give an overview of the multifaceted difficulties migrant physicians might face in German hospitals. Twenty semi-structured interviews with foreign-born and foreign-trained physicians were conducted in German. Participants were recruited via the State Chambers of Physicians and snowballing based on a maximum variation sampling strategy varying purposefully by source country and medical specialty. The interviews were recorded, transcribed verbatim, and analysed using qualitative content analysis. RESULTS: Participants described difficulties relating to healthcare institutions, own competencies, and interpersonal interactions. Participants experienced certain legal norms, the regulation of licensure and application for work, and the organization of the hospital environment as inadequate. Most struggled with their lack of setting-specific (language, cultural, clinical, and system) knowledge. Furthermore, behaviour of patients and co-workers was perceived as discriminating or inadequate for other reasons. CONCLUSIONS: This is the first study to describe the broad range of issues migrant physicians experience in Germany. Based on this information, institutional actors should devise support structures to ensure quality of care, physician wellbeing, and retention. For example, training opportunities should be offered where needed to support acquisition of setting-specific knowledge. Discrimination experienced by participants calls for better diversity management as a leadership task in healthcare institutions. Misinformation practices in recruitment could be managed by a voluntary code of ethical conduct. Further research is necessary to identify strategies that adequately address diverging normative positions between migrant health personnel and their patients and colleagues.

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