Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
-
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Aug 2008
Review[Ethics in medical education].
Ethics education is a topic of growing importance in the medical curriculum. Medical ethics can be defined as the skilled professional discourse on moral issues in patient care, medical research and the health-care system. Ethical competence comprises conscientiousness and the ability to give reasons for intuitive moral convictions. ⋯ In Germany the compulsory subject "history, theory, ethics of medicine" is predominant in the curriculum, but courses vary greatly between different universities. Further research is needed in the fields of adequate assessment formats and evaluation of final outcomes of ethics education. Interprofessional ethics education (undergraduate and postgraduate) is a major challenge for the future, especially since services for clinical ethics consultation and moral case deliberation are becoming more established in German hospitals.
-
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Aug 2008
Review[Health and justice].
The paper discusses issues of justice related to health and illness. The special normative status of health is justified based on Norman Daniels' theory of just health. As the health status of individuals is not only determined by access to health care services, the relationship between social inequalities and health status is described empirically and evaluated from an ethical perspective. ⋯ Three strategies are presented and ethically evaluated: (1) Increase efficiency ("rationalization"), (2) increase available resources and (3) limit access to services ("rationing"). Especially the pros and cons of implicit vs. explicit ways to limit services are discussed. Finally, the procedural and material ethical criteria for the just distribution of scarce health care resources are presented.
-
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jul 2008
[Data monitoring committees. Third pillar in the methodical conduct of clinical trials].
Data Monitoring Committees (DMC) are increasingly becoming integrated into the methodical procedure of clinical trials, in order to support sponsors in their central role. Whereas monitors and auditors, respectively, give quality assuring recommendations in compliance with GCP, an implemented DMC is able to give sponsors far-reaching recommendations owing to its access to unblinded data. Besides the main intention of enhancing safety during the conduction of clinical trials, the premature termination of clinical trials due to insufficient efficacy of the investigational medicinal product may be a result. Based on the European Guideline EMEA/CHMP/EWP/5872/03 Corr and based on published literature, criteria and crucial aspects for implementing this independent committee are being named If, in the course of a clinical trial, the implemented DMC notices an alteration in the risk-benefit assessment in the context of pharmacovigilance, immediate notification obligations of the Sponsor to the higher federal authorities and to the ethics committees arise.
-
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jun 2008
Comparative Study[Personal, familial and social resources and health-related quality of life in children and adolescents with chronic conditions].
The present publication describes chronic conditions of children and adolescents (asthma, ADHD, obesity) in relation to personal, familial and social resources and to health-related quality of life (HRQOL). A database of these investigations is the German health interview and examination survey of children and adolescents (KiGGS), which is representative for 0 to 17 year-olds. The above mentioned chronic conditions occur frequently in this age group and are assumed to have an influence on quality of life and to be related to a lower level of protective factors. ⋯ The chronic conditions investigated show remarkable differences in the scale values for measuring protective factors and health-related quality of life. Possible explanations are: For asthma as a chronic disease with somatic manifestation effective treatments and therapies exist, so that it has nearly no influence on the self-assessed quality of life. ADHD and obesity result in a decrease of quality of life and in the field of protective factors, possibly caused by social stigmatisation, isolation and demotivation of the concerned children and adolescents. Therefore it is important to support those children and adolescents to cope with their disease-related problems. The results illustrate that in addition to the immediate effects of chronic conditions on the concerned children and their families, it is the quality of life and the familial and social environment that should be specifically addressed in further studies.