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.
Medical benefit is the crucial factor in the evidence-based decision-making process of the Federal Joint Committee (G-BA) of Germany. To review the decisions on population-based screening methods from January 2000 to December 2009, we analysed the coverage decisions. During this period of time, the G-BA decided on 14 screening methods, predominantly dealing with the early diagnoses of serious diseases. In 8 cases a positive assessment led to reimbursement by the statutory health insurance funds, in 5 cases the assessment was negative and in one case the conditions were changed. For 7 assessments, a fully reported review was available, 4 of this were positively evaluated. In 2 of these cases, controlled screening studies documented the benefit of the screening method. In another case there was only a case series without a control group. For the fourth method, the question for the benefit of the screening method was divided into 3 sub questions, investigated separately in different studies. The methods of benefit assessments have changed very much over time. A revision of the rules of procedure for the assessment of medical screening methods is advisable.
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