[What's the evidence base for non-medical and non-technical therapeutic interventions?]. / Evidenzlage nicht-medikamentöser und nicht-technischer Behandlungsverfahren.

Health-related interventions that do not include drugs or technical procedures have not appeared very often in the German Federal Joint Committee's (GBA) evidence-based decision making process over the last years. In this regard the GBA has so far never given any instructions to the Institute for Quality and Efficiency in Health Care (IQWiG). The level of evidence for these methods is often limited by the lack of randomised controlled trials. The available studies often show a high risk of bias because of poor planning, processing and reporting as well as lack of blinding. External validity is often limited by use of a standardised monotherapy in the study, but a mix of different, individualised methods in the field. Another common problem is the lack of patient-related, long-term outcome variables. Further research is needed to develop methods for high-quality trials and evidence-based assessments in the area of non-medical, non-technical therapeutic interventions. (As supplied by publisher).

[Training courses in Evidence-based Medicine at the Federal Joint Committee]. / Fortbildungskurse zu Themen der Evidenzbasierten Medizin im Gemeinsamen Bundesausschuss.

Since 2006 the office of the Federal Joint Committee (FJC) has been offering training courses in Evidence-based Medicine (EbM) to its delegates. The courses were initiated due to a comprehensive and far-reaching restructuring of the FJC. For example, in 2004 it was decided to involve patient representatives in the discussions. Furthermore, the enactment of the cross-sectoral Code of Procedure in 2005 led to the removal of sectoral differences in the evaluation of the benefit of diagnostic and therapeutic methods. The main aim of the training courses is to build a common understanding of EbM in the interdisciplinary boards of the FJC. From the first course in 2006 until the middle of 2012, 385 people participated in these courses. Since many of them attended more than one course, the total number of participants is 663. In 2011, the courses were certified as the "Basic EbM-Course" by the German Network for Evidence-Based Medicine. The results of the course feedback and the continuing demand for further courses confirm their successful implementation and demonstrate that teaching EbM to groups with a fairly heterogeneous academic and professional background is advantageous.

The risk of malformation following assisted reproduction.

INTRODUCTION: Intracytoplasmatic sperm injection (ICSI) is currently the most frequently used human reproductive technology in Germany. ICSI was introduced as routine, insurance-funded medical care in 2002 by the Federal Joint Committee. A re-evaluation of published literature on malformation rates in children born of ICSI pregnancies within a period of three years formed part of the committee's decision. The analysis investigated whether ICSI increases the risk of malformation in the offspring, compared to in vitro fertilization (IVF) and natural conception. METHODS: Systematic literature review. RESULTS: 929 studies were identified. Three meta-analyses, 15 studies investigating malformations, and 12 studies analyzing imprinting disorders were included. The risk of malformation was not significantly different in nine studies comparing ICSI versus IVF. Two meta-analyses and three of eight cohort studies and retrospective analysis showed significantly more severe malformations after assisted reproduction than after natural conception. The remaining five studies displayed no significant results. Current evidence does not show a higher risk of major malformations in the offspring resulting from the use of ICSI compared to IVF. However, there is evidence that both techniques increase the risk for major malformations considerably, compared to natural conception, and further research is needed. The validity of the results is low since the studies were heterogeneous and the cohorts used in the studies had limited comparability.

[Benefits and benefits assessment: the principles of evidence-based medicine and health technology assessment as a decisional basis for the federal joint committee]. / Vom Nutzen der Nutzenbewertung: Die Prinzipien der evidenzbasierten Medizin und des Health Technology Assessments als Entscheidungsgrundlage des Gemeinsamen Bundesausschusses.

In the former German Federal Committee of SHI (-accredited) Physicians and Health Insurance Funds (Bundesausschuss der Arzte und Krankerkassen) a full paradigmatic change was initiated in 1990 by establishing the NUB Committee (NUB = New Methods of Diagnosis and Treatment). The NUB committee and its successor, the Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA), extended the basis of their decision making process. In order to evaluate new methods of diagnosis and treatment, the methods of Evidence-based Medicine (EbM) were increasingly taken into account aiming to establish a readjusted set of criteria for the evaluation and introduction of new diagnostic and therapeutic methods. In the beginning the criteria of Evidence-based Medicine (EBM) were applied to the methods of medical diagnosis and treatment only, but in the meantime have consistently been extended to also cover the evaluation of new physiotherapeutic therapies, psychotherapeutic treatments and measures of early diagnosis and screening, the costs of which are reimbursed by the statutory health insurance (SHI). The methodology of the G-BA is in compliance with the international standards of EbM and Health Technology Assessment (HTA) and is the mandatory basis of its work, laid down in its code of procedure. This article gives a detailed description of its mode of operation, reflecting in addition the work of similar institutions in other countries with often comparable modes of operation.