Hierarchie der Evidenz Die unterschiedliche Aussagekraft wissenschaftlicher Untersuchungen

Randomized controlled trials (RCTs) were introduced into clinical research in the fourties, in the United Kingdom. The RCT established as a gold standard that is still the best option for proving efficacy of medical interventions. However, as well as testing efficacy, clinical trials must analyze the safety of therapeutic methods. Retrospective, individual experiences or case series remain important in medical science, but, due to methodological flaws, both are regarded as less reliable when compared to evidences obtained from prospective, controlled trials. Depending on the method used for analyzing efficacy the information obtained differ in quality. Therefore a hierarchy of evidences has been established. Initially it has been used to assess the quality of preventive interventions, but it may also be applied to other fields, for example, diagnostics. This hierarchy of evidence is one of the cornerstones of evidence-based medicine. It is also of value in areas such as accreditation and approval of medical interventions. For instance, the statutory German Standing Committee of Physicians and Sickness Funds has adopted a hierarchy of evidence for the accreditation of medical interventions in public, ambulatory health care.     

Die Rolle von HTA-Berichten im deutschen Gesundheitswesen

Like other health technologies, HTA should be judged on the quality and size of its effects. However, it is only in recent years that this aspect has received increased attention. A comprehensive theoretical analysis is still missing. In this article national and international studies on the influence of HTA reports are presented. On the basis of theoretical models, the thesis is developed that the potential of HTA reports is much more extensive and complex than has been generally assumed. In order to make use of this potential, a stepwise procedure is proposed, comprising the involvement of the groups concerned, the explicit inclusion of impact objectives in all HTA reports, and the subsequent evaluation of the effects produced. This procedure is illustrated by the example of one HTA topic.     

Die Rolle der Pflege im Gesundheitswesen

As a result of recent demographic developments, there has been an increased demand for high-quality health care. Among the various health professions, caregiving represents the largest professional group, numbering approximately 820,000 caregivers. Despite its size, this group is failing to meet basic conditions in line with international standards that secure adequate care. This failing is primarily due to the special path that Germany took regarding healthcare at the end of the nineteenth century and on which it continues to this day. It manifests itself in a heteronomy to which the professional group is permanently subjected by lobbies and policies that view health care from a perspective whose primary aim is to reduce unemployment. The present lack of organization of caregivers has frustrated their political assertiveness; and not least because of this, many caregivers leave the profession early. The profession itself is grappling with its professional identity. The development of expert standards, research into care, ethical reflections, as well as the struggle for common professional training are positive signs in this ongoing debate and are reflected in the positive feedback received from patients. The interdisciplinary dialogue between caregivers and physicians is in need of improvement. The first signs of progress are evident within the framework of health care ethics committees. This dialogue would certainly benefit both the professional group as well as the patients.     

Hierarchie der Evidenz Die unterschiedliche Aussagekraft wissenschaftlicher Untersuchungen Die unterschiedliche Aussagekraft wissenschaftlicher Untersuchungen

In der medizinischen Erkenntnistherorie hat mit der Einführung der randomisierten, kontrollierten Studie in den vierziger Jahren ein Paradigmenwechsel stattgefunden. Nach der Abkehr von der retrospektiven, individuellen Erfahrung Einzelner als Ma?stab für die Wirksamkeit einer Methode gilt für die Etablierung der Wirksamkeit die randomisierte kontrollierte Studie (RCT) derzeit als Goldstandard. Entsprechend der Fragestellung (Therapie, Diagnostik, Pr?vention, Kl?rung von Nebenwirkungen), des Problemhintergrundes (z. B. Erkrankung, gegenw?rtige therapeutische Alternativen) und den Charakteristika der zu untersuchenden Intervention (z. B. Medikament, Operation, bildgebende Diagnostik) kann aus einem reichhaltigen Instrumentarium der klinischen Forschung das entsprechend angemessene Studienkonzept ausgew?hlt werden. Dabei lassen sich nicht immer alle M?glichkeiten des Erkenntnisgewinns aussch?pfen: Sichergestellt werden sollte hingegen immer, dass den Patienten die bestm?gliche Information und auch Therapie zur Verfügung gestellt wird. Ausgehend von dem Goldstandard RCT hat sich deshalb eine Hierarchie der Evidenz etabliert, die verschiedenen klinischen Erkenntnissen (von der Expertenaussage bis zur klinischen Studie) unterschiedliche Aussagekraft beimisst. In der t?glichen Praxis findet diese Evidenzhierarchie Anwendung sowohl in der evidenzbasierten Medizin, bei der Erstellung von HTA-Berichten als auch in der Versorgungsplanung wie beispielsweise im Bundesausschuss der ?rzte und Krankenkassen und hat sich dort bew?hrt.     

Die Begutachtung im Rahmen der sozialen Pflegeversicherung

This article deals with the validity of nursing care assessment as carried out by the Medical Services of the Statutory Health Insurance. The investigation is based on data published by the Nursing Care Insurance and the Medical Services and on results of studies on nursing care assessment. The author argues that the assessment is not a scientific study but primarily a social interaction. As any type of social interaction, the assessment is influenced by values, role expectations, interpretation patterns and interaction competence. In the case of the nursing care assessment, these influences seem to cause a bias towards social status and sex. An analysis of nursing care minutes allowed brings up the question of whether nursing care levels were governed by financial goals. The author concludes that there are considerable reservations against using the data of the Nursing Care Insurance for epidemiological purposes. These reservations are also valid for the nursing care statistics of the Federal Office for Statistics, because they are partly based on the data of the Statutory Nursing Care Insurance.     

Die Rolle von Zytokinen bei Allergien und Asthma

Allergic reactions are characterized by inappropriate immune responses to antigens which are tolerated by most people.After the initial demonstration of different subpopulations of T-helper cells characterized by their cytokine expression profile it has been recognized that T_H2 cells and their cytokines (IL-4, IL-5, IL-9 and IL-13) are strongly associated with allergic responses.T_H2 cytokines have crucial functions in the development of allergic hyperreactivity and during initiation and progression of allergic responses.Therapeutic approaches for the selective inhibition of T_H2 cytokines are already in clinical trials.Further subpopulations of T cells (T_H1,T_H3,T_R1) mediate allergic responses through the secretion of cytokines which suppress T_H2 cells and their effector functions.Allergysuppressing cytokines like IFN-γ, IL-10 and TGF-β can be considered as further targets for manipulating the immune system in allergic diseases.These cytokines as well as agents modulating their specific expression are currently under intensive investigation.     

Die Rolle des Internets bei der Elimination von Infektionskrankheiten

Background

The World Health Organization (WHO) has declared the elimination of measles as a global goal. According to the WHO, one critical challenge for countries such as Germany is managing perceptions and misperceptions about vaccination. Criticism and misinformation about vaccines are widespread, e.g., on the Internet, and they support the development of misperceptions, vaccine hesitancy, and fear. By contrast, owing to vaccination the actual incidence of measles is low and hardly anyone is familiar with measles as a severely infectious disease. This may lead to the incorrect perception of measles as a harmless children’s disease. Education on the risks of infection and of vaccination should therefore be combined with effective debunking of misperceptions, both of which should govern the management of perceptions and misperceptions.

Aim

The objective of this contribution is to propose and discuss several approaches with respect to the Janus-like role of the Internet: On the one hand, it serves as a source of anti-vaccination misinformation and is therefore responsible for the development of misperceptions. On the other hand, it can serve as the ideal platform for health agencies to educate the public and to debunk misinformation.

Conclusion

This contribution suggests how an effective management of perceptions and misperceptions can take place on different levels of communication and how the Internet may be actively used to reach this goal. A collection of Internet links for patients and health-care personnel are recommended.     

Die Rolle der Hochschulmedizin bei der Entwicklung von Leitlinien

Clinical guidelines are bridges between clinical research and patient care. In Germany, medical societies and university medicine are the main bodies responsible for the development, dissemination, and updating of high quality guidelines. The high demand on these to be based on evidence, clinical judgement, and structured consensus requires considerable resources. Currently, there is an inequality between the resources available to university hospitals and the incentives they receive. Financial and scientific recognition of the professionals, who develop and disseminate these guidelines, should be improved.     

Gesundheitliche Beurteilung von Kunststoffen im Rahmen des Lebensmittel- und Bedarfsgegenständegesetzes

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz -     

Die Gesundheit von Studierenden im Bologna-Prozess

Background

In comparison with different countries, there is a sporadic database in Germany which reflects the health status of students. According to this, the needs of the target group have to be mapped and conclusions for health promotion in the university setting have to be drawn.

Aims

Initially, the health-related behavior and the health status of the students of the Coburg University of Applied Sciences were evaluated. Based on these results, specific measures that can be integrated into the daily routine of the university are recommended. These procedures can be transferred to comparable universities.

Results

About 85% of the students describe their health as important. Female students tend to evaluate their health higher. Less than 50% of the respondents declare their well-being as??good?? or??very good.?? More than 90% of the students express aims concerning their personal health behavior. Almost one in two students describe an above average stress dimension as well as feelings of strain, which are mainly caused by the consequences of organizing their studies. Studying is partly accompanied by a higher consumption of legal drugs. Only 5% of the students use relaxation techniques for decreasing stress regularly. However, one in four students show an interest in methods aimed at relaxation. Half of the students participate in endurance sports.

Conclusion

The majority of the respondents describe an interest in a whole food diet, although awareness of healthy eating is missing. The results show a lack of efficient stress management. Structured and sustainable integrated health promotion initiatives within the university environment are strongly recommended.     

Gesundheitliche Beurteilung von Kunststoffen im Rahmen des Lebensmittel- und Bedarfsgegenständegesetzes

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz -     

Die Rolle randomisierter kontrollierter Studien bei der medizinischen Bewertung von Routineverfahren

If a demand exists for the evaluation of the favourable and adverse effects of a medical procedure, a comparison is required; this comparison should be fair. The only procedure that ensures a fair comparison is randomisation. Randomised controlled trials (RCTs) therefore represent the gold standard in the evaluation of medical procedures; the non-application of a randomisation process must be justified in detail in individual cases. Reasons presented for not conducting an RCT are mainly based on a misunderstanding of the term "randomisation". They may also be based on circumstances where the conduct of any simultaneous comparison is unsuitable (independent of the mode of allocation) or on situations where there is practically no hypothesis available for a comparison, or even for a study. These factors are taken into account by the current regulations valid in Germany on the approval of drugs and on the reimbursement eligibility of health care services by statutory health insurance.