Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Aug 2017
Review[Joint pilot project of the German higher federal authorities and ethics committees on implementing the EU Regulation on clinical trials].
The European Clinical Trials Regulation 536/2014 and the corresponding national legal transitions will require close cooperation between the federal higher authorities and ethics committees in the assessment of clinical trial applications involving medicinal products in humans. In preparation for this, a pilot project was launched to simulate the future processes of the regulation in line with current legal requirements and in order to give applicants, authorities and ethics committees the opportunity to familiarise themselves with the new procedures. ⋯ Compliance with the deadlines set by federal authorities and ethics committee shows that the technical infrastructures and processes established in the pilot procedure are fully functional. The cooperation between the federal higher authorities and ethics committees was very successful from the perspective of the parties involved.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · May 2017
Review[se-atlas - the health service information platform for people with rare diseases : Supporting research on medical care institutions and support groups].
se-atlas - the health service information platform for rare diseases - is part of the German National Action Plan for People with Rare Diseases and is funded by the German Federal Ministry of Health. The objective of se-atlas as a web-based platform is to illustrate those medical care institutions that are linked to rare diseases, in a transparent and user-friendly way. The website provides an overview of medical care institutions and support groups focusing on rare diseases in Germany. ⋯ Among this data are the current rare diseases centres in Germany, which play a major role in providing patient-centred healthcare by acting as primary contact points for people with rare diseases. Further expansion and maintenance of the data base raises several organisational and software-related challenges. For one, the data should be completed by adding more high-quality information, while not neglecting the existing entries and maintaining their high level of quality in the long term.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2017
[Improving pre- and perioperative hospital care : Major elective surgery].
Surgery is aimed at improving a patient's health. However, surgery is plagued with a risk of negative consequences, such as perioperative complications and prolonged hospitalization. Also, achieving preoperative levels of physical functionality may be delayed. ⋯ Preoperative screening is aimed at identifying frail, high-risk patients at an early stage, and advising these high-risk patients to participate in outpatient exercise training (prehabilitation) as soon as possible. By improving preoperative physical fitness, a patient is able to better withstand the impact of major surgery and this will lead to both a reduced risk of negative side effects and better short-term outcomes as a result. Besides prehabilitation, treatment culture and infrastructure should be inherently changing in such a way that patients stay as active as they can, socially, mentally and physically after discharge.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jan 2017
[Special medical problems in end-of-life care : Crisis at the end of life - Which therapy is adequate and when is redefining treatment goals appropriate?]
Crisis at the end of life are exceptional challenges for patients, relatives and therapists. With respect to the individual treatment goals and the patients' autonomy, therapeutic action should be commenced in an adequate manner in order to preserve the patients' quality of life as much as possible. Advance care planning for specific critical scenarios may be helpful in order to treat patients according to their wishes and values even if they are not capable to express themselves. ⋯ Sedative medication may reduce stress, for instance in the case of acute catastrophic bleeding. Palliative sedation is an ultima ratio concept for refractory symptoms at the end of life. Clinical practice guidelines (such as the German guideline "Palliative care for patients with incurable cancer") may provide an overview of the evidence base on symptom-guided therapy at the end of life.