Das Gesundheitswesen
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Das Gesundheitswesen · Mar 2009
Multicenter Study[The quality assurance programme of the statutory health insurance funds in medical rehabilitation: results and further developments].
This study reports on the results of the quality assurance programme of the statutory health insurance funds in medical rehabilitation (QS Reha programme) and on the further development of the programme in 2007 to 2008. By October 2008, a total of 240 rehabilitation centres with 283 specialised departments were participating in the QS-Reha programme. ⋯ The preliminary results of the programme provide a comprehensive view of the quality of medical rehabilitation. Limitations exist concerning evidence-based structural quality criteria, methodological problems of patient-reported outcomes and the occurrence of non-responders and dropouts. The reworking of the QS Reha programme pursued the goal of improving the cost-benefit ratio of compiling data without impairing the methodological soundness of the programme. The new concept is scheduled to be implemented routinely beginning in 2009.
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Das Gesundheitswesen · Mar 2009
[Clinical trials with minors in Germany--effects of the 12th amendment to the German Drug Code on the numbers of applications to Institutional Review Boards (IRB)].
The availability of licensed medication for children and adolescents depends on the frequency of clinical trials within this age group. In Germany legislation the framework for clinical trials was changed essentially in 2004 by the 12th amendment on the German Drug Code (AMG). This paper studies the changes in applications to the IRBs for clinical trials in adults and minors before and after implementation of the 12th amendment. ⋯ The 12th amendment to the German Drug Code had only slight effects on the number of clinical trials in general and especially on the number of clinical trials with minors. Overall, clinical trial with minors make only a small proportion of all applications for clinical trials to the IRB in Germany. The EU regulation on medical products for children may cause an increasing number of clinical trials with minors in the future.