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Stormer M.,Universitatsklinikum Cologne | Vollmer T.,Ruhr University Bochum
Transfusion Medicine and Hemotherapy | Year: 2014

Bacterial contamination of blood components and the prevention of transfusion-associated bacterial infection still remains a major challenge in transfusion medicine. Over the past few decades, a significant reduction in the transmission of viral infections has been achieved due to the introduction of mandatory virus screening. Platelet concentrates (PCs) represent one of the highest risks for bacterial infection. This is due to the required storage conditions for PCs in gas-permeable containers at room temperature with constant agitation, which support bacterial proliferation from low contamination levels to high titers. In contrast to virus screening, since 1997 in Germany bacterial testing of PCs is only performed as a routine quality control or, since 2008, to prolong the shelf life to 5 days. In general, bacterial screening of PCs by cultivation methods is implemented by the various blood services. Although these culturing systems will remain the gold standard, the significance of rapid methods for screening for bacterial contamination has increased over the last few years. These new methods provide powerful tools for increasing the bacterial safety of blood components. This article summarizes the course of policies and provisions introduced to increase bacterial safety of blood components in Germany. Furthermore, we give an overview of the different diagnostic methods for bacterial screening of PCs and their current applicability in routine screening processes. © 2014 S. Karger GmbH, Freiburg. Source

Wardelmann E.,Universitatsklinikum Cologne
Der Pathologe | Year: 2012

Gastrointestinal stromal tumors (GIST) are the most common mesenchymal tumors in the digestive tract. In up to 90% of cases, they are characterized by activating mutations in the KIT or the PDGFRA gene. GIST represent a paradigm for successful targeted treatment with tyrosine kinase inhibitors (TKI). Since the approval of the TKI imatinib in 2002 the survival of patients with metastatic GIST has tripled. The next logical step was the concept of using imatinib in an adjuvant approach, which was recently shown to increase overall survival significantly. In both settings, the mutational status has high predictive implications. In detail, GIST with KIT exon 11 mutations show the best response rates with partial remission rates of up to 80%. In KIT exon 9 mutations, a doubled daily dose of 800 mg imatinib is now standard. The PDGFRA exon 18 mutation D842V has been shown to lead to primary resistance. The treatment strategy in GIST is driven by their molecular characterisation. Further research has increased our knowledge on resistance mechanisms in solid tumors against TKI. The number of patients with secondary resistance due to acquired KIT mutations is increasing with treatment duration. Strategies to address this situation are the introduction of novel pathway inhibitors targeting different levels of signal transduction pathways, such as the mTOR/Akt pathway, the RAS/RAF pathway, histone deacetylation, among others. Among the GIST without mutations in the common hot spot regions of KIT and PDGFRA, the so-called wildtype GIST, further genomic subgroups have been identified. One such subgroup carries inactivating germline mutations in the genes encoding succinate dehydrogenase B, C, or D. They are associated with the occurrence of paragangliomas, so-called Carney-Stratakis syndrome. Most frequently, these GIST are located in the stomach, showing an epithelioid phenotype and a multinodular growth pattern. They preferentially occur in young females and often show lymph node metastases, the latter being very unusual in sporadic GIST. In sporadic Carney's triad additional pulmonary chondromas are observed and there are no SDH mutations. Another small subgroup of sporadic GIST present with BRAF mutations as an alternative genomic event. Finally, very rare kindreds with germline mutations in either KIT or PDGFRA have been described who develop multiple GIST and depending on the mutational subtype mastocytosis, hyperpigmentation and/or dysphagia. In summary, the molecular characterisation of GIST has revolutionized their treatment due to increasing knowledge about the high relevance of predictive molecular typing in solid tumors. Source

Despite the use of biologics many patients do not achieve remission or reduced disease activity, which raises the question of the optimal therapy when these therapy targets are not achieved. Most data from clinical studies and registry data refer to the approach following the unsuccessful use of one or more tumor necrosis factor (TNF) inhibitors. Randomized controlled studies investigating the effectiveness of a further biologic or TNF inhibitor in patients who received abatacept, tocilizumab or rituximab in the first line therapy are currently lacking, with the exception of the German MIRAI study. The majority of registry data and observational studies suggest that when the use of a TNF inhibitor is unsuccessful it is advantageous to change to a non-TNF biologic. This does not exclude that a change within the group of TNF inhibitors can represent an appropriate option, e.g. by injection or infusion reactions or secondary therapy failure. Whether determination of serum levels and neutralizing antibodies aids decision-making for individual patients, must currently remain open. The option to change within an active ingredient group of biologics only currently applies to the group of TNF inhibitors; however, with the development of further antibodies inhibiting interleukin 6, this question will also apply to this group of substances. The question of the optimal strategy after failure of the first and second line biologics will be asked more frequently when the therapy targets of remission and low disease activity are more stringently strived for. Predictive markers for an optimal approach to the sequential administration of biologics are lacking. In order to answer this question clinical studies which investigate the therapeutic approach in a randomized and controlled manner will be necessary in the future. © 2015, Springer-Verlag Berlin Heidelberg. Source

Reorganization of health care according to economic principles in Germany after introduction of a flat rate reimbursement for in-patients by diagnosis-related groups (DRGs) implies a more cost-efficient patient care. Optimal and complete coding of ICD-10 diagnosis and procedure codes according to OPS301 are just one essential aspect. A comparison of clinic internal costs and revenues, identification and elimination of cost drivers, modelling of reimbursement alternatives, but especially integration of information about costs and revenues at the level of resource decision, the physicians, as well as joint decision-making on rules for high quality of care at lower costs, is a new as yet insufficiently used approach. An expert for coding and reimbursement in a gynecology clinic is an optimizer of system and interfaces and can actively use medical as well as operative and strategic controlling to steer and shape these processes on-site. © 2010 Springer-Verlag. Source

Schmidt M.,Universitatsklinikum Cologne
Versicherungsmedizin / herausgegeben von Verband der Lebensversicherungs-Unternehmen e.V. und Verband der Privaten Krankenversicherung e.V | Year: 2011

In Germany, thyroid disorders have a long history. A sufficient iodine supply has been achieved in recent years in Germany. Thyroid nodules are frequent and mostly benign findings. Autonomous adenomas are not self-curable findings and require a definitive therapy, especially in the case of concomitant functional abnormalities (subclinical or overt hyperthyroidism). Graves' disease is the other most frequent cause of overt hyperthyroidism. In Germany, Graves' disease is treated with thyrostatic medication usually over 1-1 1/2 years, resulting in a definitive cure in about 50% of patients. In the case of therapy failure or high risk of relapse according to initial findings or complications under thyrostatic medication (leucopenia), definitive treatment mostly by way of radioactive iodine-131 is advised. Radioiodine therapy is usually well tolerated with minimal side effects and is not associated with risks such as laryngeal nerve palsy and hypoparathyroidism. Alternatively, surgical treatment is indicated in case of suspected malignancy or large thyroid volumes with relevant tracheal compression. Hashimoto's thyroiditis is the most frequent reason for hypothyroidism requiring levothyroxine substitution. In Germany, about 3500 women and 1500 men are diagnosed with papillary or follicular thyroid carcinoma each year which can be cured in the vast majority of patients. Less than 10% develop metastases after initial thyroidectomy and ablative radioiodine therapy. These patients can be treated with further therapy cycles of radioiodine. In the case of development of dedifferentiated iodine-negative, FDG-PET-positive metastatic disease treatment options are limited. In this situation, tyrosinkinase-inhibitors are a new treatment option which are being evaluated in current and prospective randomised controlled trials. Thyroid carcinoma (C73) is the most frequent reason for medical pensions because of thyroid disease. The rare anaplastic thyroid carcinoma is one of the most malignant tumours overall being usually fatal within a few months after diagnosis. Source

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