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The differential cross sections of 9Be(3He,3He 0)9Be elastic scattering and of the 9Be(3He,p 0,1,2,3,4+5,6,7)11B reactions have been determined in the energy range from 1.6 to 6 MeV at six backward angles from 120° to 170°, with a step of 10°. The experiments were performed at the 4 MV Dynamitron Tandem Laboratory of the Central Unit for Ion Beams and Radionuclides of the Ruhr University Bochum in Germany. The obtained datasets have been validated through benchmarking experiments, at 8 beam energies, using a thick, high-purity, beryllium foil. The results of the present work are compared with existing ones from literature and any discrepancies observed are discussed. [ABSTRACT FROM AUTHOR]

In recent discussions about the health status of the homeless in Germany, there has been an increasing interest in the extent to which mental health disorders are appearing in this heterogeneous population. It has been argued that the growth in the homeless population has been paralleled by an increase in the numbers of single homeless people suffering from severe mental disorders. Consequently, several studies have been conducted in Europe and elsewhere during the last few decades to assess the mental health status of the homeless population. In Germany, however, there is still a lack of valid, epidemiologically based and representative data in this area. This paper focuses on the unique problems of homeless people with mental health problems in Germany who typically have multiple needs for adequate treatment and rehabilitation. Some have suggested that specific psychiatric education should be encouraged or expanded and that comprehensive and sensible service responses that allow for easily accessible and unrestrictive mental health services should be developed. There is an additional need to improve cooperation on a case-management basis between counseling centers for the homeless and healthcare institutions in order to deal effectively with the complex problems associated with homelessness. Efforts targeted at the prevention of homelessness should also be strengthened. Because of their deprived living conditions, homeless persons are seriously at risk of developing physical and/or psychological or mental morbidity. Studies from North America [1-3] and various European countries [e.g., 4] have reported elevated rates of severe mental health problems among this population, especially substance abuse disorders. However, it is difficult to generalize these results to Germany because of profound differences in health-care systems and the socioeconomic context. In Germany every citizen is covered by comprehensive health-insurance plans. A homeless person in need... [ABSTRACT FROM AUTHOR]

Objective: The objective of our study was to field test different chronic migraine (CM) criteria and compare CM epidemiological profiles, which include demographic, personal, and lifestyle characteristics, with high-frequency episodic migraine (HFEM) and low-frequency episodic migraine (LFEM).Methods: Questionnaires were mailed to a random sample of 18,000 18—65-year-olds in demographically diverse regions of Germany. The epidemiological data for the three classifications of CM, LFEM and HFEM were assessed using descriptive statistics, Pearson Chi-square, and analysis of variance tests.Results: Among 9350 respondents, CM_I was the most restrictive (N = 37, 0.4%), followed by CM_II (N = 45, 0.5%) and CM_III (N = 185, 2.0%). CM groups did not differ in distribution by age, gender, body mass index, education or smoking and alcohol consumption. Compared to those with LFEM and HFEM, those with CM (CM_III) had significantly different epidemiological profiles.Conclusions: CM prevalence varies by case definition. The epidemiological profiles of the three CM groups are similar but differ significantly from those of HFEM and LFEM. Optimal definitions for clinical practice and epidemiological research require additional field testing. [ABSTRACT FROM PUBLISHER]

Background: In Germany, around 2.250 children and adolescents are diagnosed with cancer each year. Despite generally positive long-term survival rates, many patients must cope with late effects of the disease and its treatment. This highlights the need for a well-structured, long-term approach addressing both physical and mental health issues. Currently, the German healthcare system lacks such comprehensive structures. Our study aims to evaluate the effectiveness of a structured, multidisciplinary long-term approach compared to conventional "treatment as usual" (TAU)., Methods: A prospective, multicenter study with ten pediatric university clinics in Germany will be conducted. The cluster-randomization takes place at the clinic level. Children and adolescents who completed their cancer treatment at least five years ago and their parents will be eligible to participate. While the control group (CG) receives TAU, the intervention group (IG) participates in a structured program. This program includes risk-based medical treatment and psychosocial interventions tailored to each patient's individual needs within a two-month timeframe. The primary outcome is the improvement of self-efficacy. Secondary outcomes are satisfaction with health care, improvement of health-related quality of life (HRQoL), reduction of mental health problems, and improvement of transition readiness., Discussion: This approach has the potential to optimize the health care for individuals who survived cancer during childhood or adolescence. It addresses the challenges of overuse, underuse, and misuse of health care resources. By considering both medical and psychosocial factors and promoting increased self-efficacy, independent from parental involvement, it may facilitate a smoother transition to adult medicine and enhance adherence to lifelong aftercare. If proven successful, this approach will contribute to the integration of multidisciplinary strategies into standard healthcare practice., Trial Registration: German Clinical Trials Register DRKS00029269. Registered on December 23, 2022., (© 2024. The Author(s).)

Development of Janus-kinase (JAK) inhibitors has revolutionized the therapeutic landscape for patients with myeloproliferative neoplasia (MPN). Following approval of the first JAK1/2-inhibitor Ruxolitinib, symptoms of this inflammatory disease, characterized by splenomegaly, release of inflammatory cytokines and appearance of thrombosis, could be effectively reduced for the first time. However, JAK-inhibitor treatment is limited in several aspects: 1) duration of response: 3 years after initiation of therapy more than 50% of patients have discontinued JAK-inhibitor treatment due to lack of efficacy or resistance; 2) reduction of disease burden: while effective in reducing inflammation and constitutional symptoms, JAK-inhibitors fail to reduce the malignant clone in the majority of patients and therefore lack long-term efficacy. Early clinical trials for patients with myelofibrosis (MF) have tried to address these issues for patients with suboptimal response to Ruxolitinib therapy while combination therapies with Fedratinib are rare. Recent reports provided first evidence on how the JAK2-V617F mutated myeloid cells may influence T-cell responses. JAK2-V617F promoted the synthesis of PD-L1 in MPN cells leading to limited anti-neoplastic T-cell responses, metabolic changes in T-cells and eventually JAK2-V617F-driven immune-escape of MPN cells. These findings may facilitate the use of immunotherapeutic approaches for JAK-mutated clones. Immune checkpoints refer to a variety of inhibitory pathways that are crucial for maintaining self-tolerance and modulating the duration and amplitude of physiological immune responses in peripheral tissues in order to minimize collateral tissue damage. The FRACTION study is a single arm, open label Phase II trial investigating the combination of Fedratinib with the PD-1 inhibitor Nivolumab in patients with myelofibrosis and suboptimal or lack of response to JAK-inhibitor therapy. Over a 12 months period the trial assesses longer term outcomes, particularly the effects on clinical outcomes, such as induction of clinical remissions, quality of life and improvement of anemia. No prospective clinical trial data exist for combinations of JAK- and immune-checkpoint-inhibitors in the planned MF study population and this study will provide new findings that may contribute to advancing the treatment landscape for MF patients with suboptimal responses and limited alternatives., (© 2024. The Author(s).)

Background:  The economic effects of spontaneous bacterial peritonitis (SBP), nosocomial infections (nosInf) and acute-on-chronic liver failure (ACLF) have so far been poorly studied. We analyzed the impact of these complications on treatment revenues in hospitalized patients with decompensated cirrhosis., Methods:  371 consecutive patients with decompensated liver cirrhosis, who received a paracentesis between 2012 and 2016, were included retrospectively. DRG (diagnosis-related group), "ZE/NUB" (additional charges/new examination/treatment methods), medication costs, length of hospital stay as well as different kinds of specific treatments (e. g., dialysis) were considered. Exclusion criteria included any kind of malignancy, a history of organ transplantation and/or missing accounting data., Results:  Total treatment costs (DRG + ZE/NUB) were higher in those with nosInf (€ 10,653 vs. € 5,611, p < 0.0001) driven by a longer hospital stay (23 d vs. 12 d, p < 0.0001). Of note, revenues per day were not different (€ 473 vs. € 488, p = 0.98) despite a far more complicated treatment with a more frequent need for dialysis (p < 0.0001) and high-complex care (p = 0.0002). Similarly, SBP was associated with higher total revenues (€ 10,307 vs. € 6,659, p < 0.0001). However, the far higher effort for the care of SBP patients resulted in lower daily revenues compared to patients without SBP (€ 443 vs. € 499, p = 0.18). ACLF increased treatment revenues to € 10,593 vs. €6,369 without ACLF (p < 0.0001). While treatment of ACLF was more complicated, revenue per day was not different to no-ACLF patients (€ 483 vs. € 480, p = 0.29)., Conclusion:  SBP, nosInf and/or ACLF lead to a significant increase in the effort, revenue and duration in the treatment of patients with cirrhosis. The lower daily revenue, despite a much more complex therapy, might indicate that these complications are not yet sufficiently considered in the German DRG system., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: The new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused more than 210 000 deaths worldwide. However, little is known about the causes of death and the virus's pathologic features., Objective: To validate and compare clinical findings with data from medical autopsy, virtual autopsy, and virologic tests., Design: Prospective cohort study., Setting: Autopsies performed at a single academic medical center, as mandated by the German federal state of Hamburg for patients dying with a polymerase chain reaction-confirmed diagnosis of COVID-19., Patients: The first 12 consecutive COVID-19-positive deaths., Measurements: Complete autopsy, including postmortem computed tomography and histopathologic and virologic analysis, was performed. Clinical data and medical course were evaluated., Results: Median patient age was 73 years (range, 52 to 87 years), 75% of patients were male, and death occurred in the hospital ( n  = 10) or outpatient sector ( n  = 2). Coronary heart disease and asthma or chronic obstructive pulmonary disease were the most common comorbid conditions (50% and 25%, respectively). Autopsy revealed deep venous thrombosis in 7 of 12 patients (58%) in whom venous thromboembolism was not suspected before death; pulmonary embolism was the direct cause of death in 4 patients. Postmortem computed tomography revealed reticular infiltration of the lungs with severe bilateral, dense consolidation, whereas histomorphologically diffuse alveolar damage was seen in 8 patients. In all patients, SARS-CoV-2 RNA was detected in the lung at high concentrations; viremia in 6 of 10 and 5 of 12 patients demonstrated high viral RNA titers in the liver, kidney, or heart., Limitation: Limited sample size., Conclusion: The high incidence of thromboembolic events suggests an important role of COVID-19-induced coagulopathy. Further studies are needed to investigate the molecular mechanism and overall clinical incidence of COVID-19-related death, as well as possible therapeutic interventions to reduce it., Primary Funding Source: University Medical Center Hamburg-Eppendorf.

TP53 aberrations reportedly predict favorable responses to decitabine (DAC) in acute myeloid leukemia (AML). We evaluated clinical features and outcomes associated with chromosome 17p loss or TP53 gene mutations in older, unfit DAC-treated AML patients in a phase II trial. Of 178 patients, 25 had loss of 17p in metaphase cytogenetics; 24 of these had a complex (CK+) and 21 a monosomal karyotype (MK+). In analyses in all patients and restricted to CK+ and MK+ patients, 17p loss tended to associate with higher rates of complete remission (CR), partial remission (PR), or antileukemic effect (ALE). Despite favorable response rates, there was no significant OS difference between patients with or without loss of 17p in the entire cohort or in the CK+ and MK+ cohort. TP53 mutations were identified in eight of 45 patients with material available. Five of the eight TP53-mutated patients had 17p loss. TP53-mutated patients had similar rates of CR/PR/ALE but shorter OS than those with TP53 wild type (P = 0.036). Moreover, patients with a subclone based on mutation data had shorter OS than those without (P = 0.05); only one patient with TP53-mutated AML had a subclone. In conclusion, 17p loss conferred a favorable impact on response rates, even among CK+ and MK+ patients that however could not be maintained. The effect of TP53 mutations appeared to be different; however, patient numbers were low. Future research needs to further dissect the impact of the various TP53 aberrations in HMA-based combination therapies. The limited duration of favorable responses to HMA treatment in adverse-risk genetics AML should prompt physicians to advance allografting for eligible patients in a timely fashion.

Background  An estimated 500 000 people are infected with hepatitis B in Germany, inducing an enormous burden on infected patients and the health care system. The aim of our study was to estimate the real-life costs of treating hepatitis B and to analyze sociodemographic factors. Methods  We conducted a retrospective, non-interventional, single-center study from 07/2009 to 12/2012. Information on health care delivery was extracted from patient records. Besides that, a questionnaire survey regarding sociodemographic parameters and quality of life of HBV-infected patients was performed. Results  A total of 117 patients were included in our study and grouped in six different disease stages. The response rate of our survey was 80 %. We determined annual total costs of € 3509. The different groups altered between € 221 and € 5618. The main costs (80 %) were caused by the antiviral therapy. Costs of co-medication and hospitalizations were of minor importance. Laboratory costs were primarily caused by determination of virological parameters. Route of transmission of HBV-infection was unknown in 2/3 of all cases. Restrictions in quality of life due to the HBV-infection were reported by 60 % of the patients. Patients receiving interferon treatment reported highest restrictions. In an extrapolation, we estimated total annual hepatitis B treatment costs of 430 million € in Germany. Conclusion  This is the first study estimating real-life treatment costs of hepatitis B infections in Germany. Further research should follow in the context of newly introduced generic antivirals., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

The peroneal reaction time (PRT) is used in the assessment of neuromuscular deficits in chronic functional ankle instability. Powered by the Editorial Manager and Preprint Manager from Aries Systems Corporation the present study was conducted to determine the PRT in a large collective of patients with chronic ankle instability because it is unclear if this parameter of neuromuscular deficit is prolonged. In this study 186 patients underwent a diagnostic algorithm consisting of anamnesis, clinical examination, X-ray and determination of the PRT on a tilting platform. A prolonged PRT as a manifestation of a neuromuscular deficit could be detected in the majority of the patients (n = 143, 77%). Comparing the affected and healthy legs 77 patients (41%) showed a significant difference in talar shift (p = 0.002) and talar tilt (p = 0.04) in the radiological stress views. Of these 77 patients only 15 (8%) showed radiological evidence of a mechanical problem. As a consequence of recurring ankle sprains a post-traumatic deficit in proprioception has to be expected in most cases. In general a conservative therapy approach should be followed including specific training to improve neuromuscular and proprioceptive deficits.

Objectives: Associations of interleukin-10 (IL-10) promoter single nucleotide polymorphisms (SNPs) and their haplotypes with systemic lupus erythematosus (SLE) are unclear. We extended the analysis of established proximal IL-10 promoter haplotypes to a more distal SNP with functional capacity., Methods: Two hundred and ten German caucasian SLE patients fulfilling the ACR criteria and 160 ethnically, age and sex matched controls were genotyped for IL-10 -2849 G > A, -1082 A > G, -819 T > C and -592 C > A. Haplotypes were reconstructed via a mathematical model, then allele and haplotype distributions were compared between patients and controls and patients with different disease manifestations., Results: We detected at -2849, -1082, -819 and -592 the four predominant haplotypes GGCC (22% in patients vs. 29% in controls), AGCC (24% vs. 21%), GACC (30% vs. 25%) and GATA (24% vs. 24%). GGCC was underrepresented in SLE patients, suggesting a protective effect (odds ratio (OR) 0.67, 95% confidence interval (CI) 0.48-0.94). AGCC was found significantly more frequently in patients with pathognomonic anti-dsDNA antibodies (26% vs. 15%; OR 1.98, 95% CI 1.04-3.75). As compared to patients with glomerulonephritis type V (WHO classification), the presumptive IL-10 high producer allele -2849 G was found significantly more often in patients with GN type III/IV (93% vs. 60%; OR 8.7, 95% CI 1.59-47.15)., Conclusion: Our data confirm that the complexity of the IL-10 promoter evokes the need for a meticulous analysis of its haplotypic structure in order to specify disease associations, particularly under functional aspects, thereby shedding light on the pathophysiology of SLE.

Objectives: This study aimed to determine patient-related predictors of treatment satisfaction in fibromyalgia syndrome (FMS)-patients., Methods: In a cross-sectional survey, participants with self-reported diagnosis of FMS were recruited by FMS-self help organisations and clinical institutions. The patients answered demographic and medical questionnaires, the Fibromyalgia Survey Questionnaire (FSQ) including the Somatic Severity Score (SSS) and Widespread Pain Index (WPI), the Patient Health Questionnaire (PHQ-4), and rated their treatment satisfaction on an 11-point Likert scale. The impact of patient-related variables (age, gender, partnership, educational level, time since onset of pain, time since FMS-diagnosis, health status since diagnosis, membership in FMS self-help organisations, polysymptomatic distress, anxiety and depression) and types of treatment on treatment satisfaction were tested by a multiple regression analysis., Results: The study sample (n=1651 patients) was composed mainly of middle-aged women with a long disease history, and 83.9% fulfilled the American College of Rheumatology diagnostic criteria of 2010. There was considerate variety regarding treatment satisfaction in FMS-patients, 14.8% reported no, 31.7% low, 40.8% moderate and 12.7% high satisfaction. Higher satisfaction was predicted by longer time since FMS diagnosis (p=0.03), improved health status since FMS-diagnosis (p<0.0001), lower depression score (p=0.005) and higher amount of active therapies (p<0.0001). Other sociodemographic (age, gender etc.) and disease-related variables (polysymptomatic distress intensity) did not influence treatment satisfaction., Conclusions: The results of the study illustrate the influence of patient-related factors on treatment satisfaction. Treating comorbid depression and enabling patients to actively cope with the disease might prove successful in improving treatment satisfaction of FMS-patients.

Introduction: After neoadjuvant chemoradiation (CRT), the pathologic determined lymph node (LN) status is the most important prognostic factor in rectal cancer patients. Here we assessed the prognostic impact of residual LN micrometastases (<0.2 cm) and the intramesorectal distribution of LN metastases., Patients and Methods: Surgical specimens from 81 patients with cUICC II/III rectal cancer undergoing neoadjuvant CRT and total mesorectal excision within the German Rectal Cancer Trial CAO/ARO/AIO-04 were prospectively evaluated. The entire mesorectal compartment was paraffin embedded and screened microscopically. The number and distribution of mesorectal LN macrometastases and micrometastases were correlated with disease-free (DFS) and cancer-specific overall survival (CSS)., Results: A total of 2412 LNs were detected (mean 29.8±13.7). Twenty-five patients had residual LN metastases (ypN+). The incidence of metastases in the peritumoral mesorectum was higher (7.7%) than that proximal to the tumor (1.5%), whereas no metastases were identified below the tumor level. Patients with both proximal and peritumoral involvement showed a significantly reduced CSS (hazard ratio=5.4; P<0.05). Fourteen patients with ypN+ status (56%) had micrometastases, 9 patients (36%) had only micrometastatic involvement. Patients with nodal macrometastases had a reduced DFS (P<0.01) and CSS (P<0.005) as compared with ypN0 patients, whereas residual micrometastases had no influence on survival., Conclusions: Despite the high incidence of residual LN micrometastases they did not seem to have a prognostic impact in this series. Micrometastases might indicate responsive tumors to CRT with a more favorable biology. The intramesorectal distribution of LN metastases had a prognostic impact and should be validated in further studies.

Background: Systematic reviews have reported a wide range of prevalence rates for depressive, anxiety and posttraumatic stress disorders (PTSD) in patients with fibromyalgia syndrome (FMS) which have been partially explained by setting differences. No data are currently available on the prevalence of potential mental disorders depending on the medical specialty in Germany., Material and Methods: All consecutive FMS patients of 8 study centres (3 rheumatology/orthopaedic surgery, 3 psychosomatic/pain medicine, 2 physical/integrative medicine) were assessed from February 1 to July 31, 2012 with standardised questionnaires. Patients with FMS diagnosed by a study physician were included. Non-German speaking and mentally retarded patients were excluded. The German version of the Patient Health Questionnaire 4 was used to screen for potential depressive and anxiety disorders. Severe life events were assessed by the trauma list of the Munich Composite International Diagnostic Interview and symptom criteria of PTSD of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) using the Posttraumatic Diagnostic Scale., Results: Of 538 patients, 396 patients (93.9 % women, mean age 52.3 years, mean duration since chronic widespread pain 12.8 years, mean duration since FMS diagnosis 4.5 years) were analysed. In all, 65.7 % of patients met the criteria of a potential depressive disorder, 67.9 % of a potential anxiety disorder and 45.5 % of a potential PTSD. Potential depressive disorders were more frequent in the psychosomatic/pain medicine setting than in the rheumatology setting., Conclusion: Potential mental disorders were frequent in FMS patients regardless of the medical specialty. All FMS patients of all types of clinical settings should be screened for mental disorders.

Hemolytic uremic syndrome is a multisystem disorder that is caused by infection with Shiga-toxin-producing Escherichia coli. HUS affects mainly children and is rare among adults. This retrospective case series analyzes clinical signs and MR imaging findings of 11 adult patients with HUS associated nervous system involvement during the epidemic EHEC outbreak in northern Europe with its epicenter in Hamburg in May 2011. The most prevalent imaging finding was symmetric pointy vasogenic edema of the brain stem in the acute and subacute phases of the disease (n = 5). One patient exhibited additional symmetric mesiotemporal signal changes mimicking limbic encephalitis. Two patients developed subcortical patchy lesions, and 4 subjects did not present with any signal changes. Remarkably, territorial ischemia, signs of hemorrhage, or blood-brain barrier disruption have not been detected. While brain stem lesions were transient and normalized with clinical recovery, supratentorial lesions did not resolve completely at 2-month follow-up examination.

Objectives: Systematic reviews of case-control studies demonstrated an association between self-reported childhood sexual and physical abuse and fibromyalgia syndrome (FMS). We tested in a case-control study if the association of self-reported childhood maltreatments in childhood and in adult FMS-patients is attributable to depression., Methods: All consecutive patients diagnosed with FMS of two clinical centres were included into the study from January to June 2011. Randomly selected age- and sex-matched controls from a representative survey of the general German population were used as controls. Childhood maltreatments were assessed by the German version of the Childhood Trauma Questionnaire CTQ and depression by the two-item depression scale of the German version of the Patient Health Questionnaire PHQ-4. The scores of the five CTQ-subscales were compared between FMS-patients and controls using analysis of covariance adjusting for depressed mood., Results: 153 FMS-patients (87.6% women; mean age 50.3 years) and 153 age- and sex matched participants of the general population were included. The comparison between FMS-patients and population controls, adjusted for depressed mood, demonstrated a significant group difference for emotional (p<0.001), and sexual abuse (p=0.01). Depressed mood fully accounted for group difference in physical abuse (p=0.01) and in emotional neglect (p<0.001). Depressed mood partially accounted for group difference in emotional abuse (p<0.001), but did not account for group difference in sexual abuse (p=0.10)., Conclusions: Reports of FMS-patients some on childhood maltreatments were biased by depressed mood. However, the difference in self-reported childhood sexual abuse between adult FMS-patients and population controls was not attributable to depression.

Purpose: The purpose of the current work was to prospectively measure the influence of testicular radiation dose on hormone levels, quality of life (QoL), and sexual functioning following multimodal therapy (neoadjuvant radiochemotherapy, surgery, and adjuvant chemotherapy) for rectal cancer., Patients and Methods: From November 2007 to November 2009, 83 male patients were treated at the University of Goettingen with radiochemotherapy (RCT) for locally advanced rectal cancer [total dose 50.4 Gy, concomitant chemotherapy with two cycles of 5-fluorouracil (FU) or 5-FU and oxaliplatin]. Testicular radiation doses were analyzed and correlated with hormone levels [luteinizing hormone (LH), follicle stimulating hormone (FSH), total testosterone and free androgen index (FAI) serum levels], QoL, and sexual functioning, which were determined before and up to 1 year after RCT., Results: Mean dose at the testes was 3.9 Gy (range 0.28-11.98 Gy). It was higher for tumors located < 6 cm from the anocutaneous line (p < 0.05). One year after therapy, testosterone, the testosterone/LH ratio, and the FAI/LH ratio were significantly decreased (3.5-3.0 µg/l, 0.9-0.4, 7.9-4.5, respectively) while LH and FSH (4.2-8.5 IU/l, 6.0-21.9 IU/l) were increased. QoL and sexual functioning were significantly impaired. However, there was no statistical correlation between testicular radiation dose and changes in hormone levels, QoL, or sexual functioning., Conclusion: Multimodal treatment for rectal cancer including RCT leads to hormone level changes and to impaired QoL and sexual functioning. However, because there was no apparent correlation between the analyzed parameters, QoL is probably also influenced by other factors, e.g., psychosocial aspects.

The costs of guideline-based treatment are unknown for most diseases. This also applies for economically significant infectious diseases like viral hepatitis and HIV. On the basis of the "German Guidelines for the Management of HBV Infection" from 2011 patients were grouped into HBsAg-positive, immuntolerant and chronic hepatitis patients with and without cirrhosis. Costs were divided in baseline diagnostics, monitoring and medical treatment according to the guideline. The calculation was modelled for a period of five years. Costs for virological diagnostics and imaging account for a large proportion of diagnostic costs. The main cost factors are expenses for pharmaceutical treatment with interferon or HBV polymerase inhibitors. On the assumption that only 25 % of the infected patients are diagnosed, 5-year total costs in Germany account for more than 2.5 billion Euros. Therefore, chronic hepatitis B is a disease with a very high economic burden. The aim of a guideline treatment is to prevent the development of cirrhosis with all its complications as well as the development of liver-cell carcinoma. Prophylactic vaccination against hepatitis B should be advised also considering the potential economic impact., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose: Preoperative chemoradiotherapy (CRT) has been established as standard treatment for locally advanced rectal cancer after first results of the CAO/ARO/AIO-94 [Working Group of Surgical Oncology/Working Group of Radiation Oncology/Working Group of Medical Oncology of the Germany Cancer Society] trial, published in 2004, showed an improved local control rate. However, after a median follow-up of 46 months, no survival benefit could be shown. Here, we report long-term results with a median follow-up of 134 months., Patients and Methods: A total of 823 patients with stage II to III rectal cancer were randomly assigned to preoperative CRT with fluorouracil (FU), total mesorectal excision surgery, and adjuvant FU chemotherapy, or the same schedule of CRT used postoperatively. The study was designed to have 80% power to detect a difference of 10% in 5-year overall survival as the primary end point. Secondary end points included the cumulative incidence of local and distant relapses and disease-free survival., Results: Of 799 eligible patients, 404 were randomly assigned to preoperative and 395 to postoperative CRT. According to intention-to-treat analysis, overall survival at 10 years was 59.6% in the preoperative arm and 59.9% in the postoperative arm (P = .85). The 10-year cumulative incidence of local relapse was 7.1% and 10.1% in the pre- and postoperative arms, respectively (P = .048). No significant differences were detected for 10-year cumulative incidence of distant metastases (29.8% and 29.6%; P = .9) and disease-free survival., Conclusion: There is a persisting significant improvement of pre- versus postoperative CRT on local control; however, there was no effect on overall survival. Integrating more effective systemic treatment into the multimodal therapy has been adopted in the CAO/ARO/AIO-04 trial to possibly reduce distant metastases and improve survival.

Background: Consumer surveys provide information on effectiveness and side effects of medical interventions in routine clinical care. A report of fibromyalgia syndrome (FMS) consumers has not been carried out in Europe., Methods: The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacological FMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). The questionnaire was distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care., Results: 1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. The most frequently used therapies were self-management strategies, prescription pain medication and aerobic exercise. The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, local cold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems., Conclusion: The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS, and challenges the strong recommendations for drug therapies given by FMS-guidelines.

This report concerns a 55-year-old female patient who presented with headache, dry right eye and dry nose on the right side. After 5 months magnetic resonance imaging (MRI) was carried out but no pathological findings were diagnosed. Right-sided facial pain appeared 6 months later and a second MRI was carried out but only fluid retention in the right mastoid was diagnosed. After a further 8 months paresis of the right abducent nerve occurred and a computed tomography (CT) scan of the petrous bone showed extensive destruction of the apex of the petrous pyramid. Subsequently a third MRI revealed a tumor of about 5 cm in diameter in the right pterygopalatine fossa which was also retrospectively visible in the first MRI with a size of approximately 3 cm and in the second MRI with 4 cm in diameter. The histological examination after biopsy resulted in the diagnosis of a nasopharyngeal carcinoma and radiochemotherapy was initiated. The patient died 9 months later. The relatives of the patient applied to the arbitration board for medical liability which requested expert opinions in neuroradiology and otorhinolaryngology. The board came to the conclusion that the claims for damages against the radiologist who had made the three MRIs were well-founded and recommended an extrajudicial settlement.

Purpose: Correct diagnosis, surgical treatment, and perioperative management of patients with esophageal carcinoma remain crucial for prognosis within multimodal treatment procedures. This study aims to achieve a consensus regarding current management strategies in esophageal cancer by questioning a panel of experts from the German Advanced Surgical Treatment Study (GAST) group, comprised of 9 centers specialized in esophageal surgery, with a combined total of >220 esophagectomies per year., Materials and Methods: The Delphi method, a systematic and interactive, evidence-based approach, was used to obtain consensus statements from the GAST group regarding ambiguities and disparities in diagnosis, patient selection, surgical technique, and perioperative management of patients with esophageal carcinoma. After four rounds of surveys, agreement was measured by Likert scales and defined as full (100% agreement), near (≥66.6% agreement), or no consensus (<66.6% agreement)., Results: Full or near consensus was obtained for essential aspects of esophageal cancer staging, proper surgical technique, perioperative management and indication for primary surgery, and neoadjuvant treatment or palliative treatment. No consensus was achieved regarding acceptability of minimally invasive technique and postoperative nutrition after esophagectomy., Conclusion: The GAST consensus statement represents a position paper for treatment of patients with esophageal carcinoma which both contributes to the development of clinical treatment guidelines and outlines topics in need of further clinical studies.

A summary of a critical review by a working group of the German Federal Environment Agency and the German Federal Institute for Risk Assessment on the carcinogenic potential of nanomaterials is presented. After a critical review of the available data, we conclude that the potential carcinogenic risk of nanomaterials can currently be assessed only on a case-by-case basis. There is certain evidence that different forms of CNTs (carbon nanotubes) and nanoscale TiO(2) particles may induce tumours in sensitive animal models. It is assumed that the mode of action of the inhalation toxicity of asbestos-like fibres and of inhalable fractions of biopersistent fine dusts of low toxicity (nano-TiO(2)) is linked to chronic inflammatory processes. Existing epidemiological studies on carcinogenicity for these manufactured nanomaterials are not sufficiently conclusive. Generally speaking, the database is not adequate for an assessment of the carcinogenic potential of nanomaterials. Whereas a number of studies provide evidence of a nano-specific potential to induce tumours, other studies did not. This is possibly due to insufficient characterisation of the test material, difference in the experimental design, the use of different animal models and species and/or differences in dosimetry (both with regard to the appropriate dose metric and the estimated effective dose quantities). An assessment of the carcinogenic potential and its relevance for humans are currently fraught with uncertainty. Furthermore, the nano-specificity of the carcinogenic effects observed cannot be conclusively evaluated. Specific carcinogenic effects of nanomaterials may be both quantitative and qualitative. In quantitative terms, the carcinogenic effects of nanoparticles are thought to be simply more pronounced compared to the corresponding bulk material (due, for example, to the considerably larger surface area and higher number of particles relative to the mass concentration). On the other hand, certain nano-properties such as small size, shape and reactivity, retention time and distribution in the body after overcoming biological barriers, as well as subcellular and molecular interactions may play a role in determining the toxicity in qualitative terms, i.e. the carcinogenic potential of the nanomaterial and the non-nanoscale comparison substance may be fundamentally different. All of these factors leave no doubt about the fact that there is a great need for research in this area and that new standardised test methods need to be developed or existing ones adapted at the very least to achieve valid answers regarding the carcinogenic potential of nanomaterials. Global production of nanomaterials is set to increase in the years to come, and new materials with new properties will be developed, so that greater human exposure to them must be anticipated. No reliable conclusions can currently be drawn about exposure to nanoparticles and their release from products. Firstly, there are substantial deficits in information about the processing of nanomaterials in products and preparations. Secondly, there are only a small number of studies on nanoparticle release, and reliable techniques for measuring and monitoring nanomaterials in different environmental media are still being developed which is both complex and costly. Despite the uncertainties, the findings to date on the carcinogenic potential of nanomaterials must be taken seriously, and precautionary measures to minimise exposure should go hand in hand with the development of a comprehensive and conclusive toxicological methodology and testing procedure for nanostructured materials that includes all possible exposure routes. With regard to possible legal classification of nanomaterials and the transferability of classifications of their non-nanomaterial counterparts, we believe it is necessary to have separate procedures for nano and non-nano forms. Furthermore, criteria for evaluating nano-specific carcinogenic properties should be constantly updated and adapted to the state of knowledge. There is a need here for amendments to be made to EU legislation, as currently nanoforms do not represent a separate category of substance in their own right., (Copyright © 2010 Elsevier GmbH. All rights reserved.)

Objectives: The various biologic agents currently available for the treatment of RA can be administered subcutaneously (s.c.) or via intravenous (i.v.) infusion with variable intervals depending on the drug. This investigation aims to identify the preferences and concerns of affected patients and their physicians., Methods: We conducted a survey of 102 patients with RA currently receiving Rituximab (RTX) therapy. They were asked about different aspects of their current and previous RA therapy, including overall satisfaction, tolerability, mode of drug administration, as well as duration and intervals. In addition, 17 rheumatologists were asked about different aspects of s.c. or i.v. drug administration, their preference and the suspected preference of their patients., Results: The mean age of our patients was 59 ± 11.2 years. Patients had failed ≥2 DMARD therapies and ≥ 1 biologic treatment. The impact of RTX infusions on planning different activities including job, hobbies or travelling was considered as low or very low in 76% of the respondents. Interestingly, 63.4% of patients would prefer an infusion every 6-9 months as RA therapy, whereas 21.5% would prefer tablets only; 12.9% of our patient cohort would prefer s.c. injections every second week, and only 2% would prefer an infusion every month. In all, 92% of patients questioned would choose RTX therapy again. In contrast, 88% of rheumatologists preferred s.c. injection and even 94% of them assumed that their patients would do so as well if they had the choice. The suggested reasons included greater flexibility, convenience and independence during s.c. therapy., Conclusion: Contrary to the assumption of rheumatologists, we have demonstrated a preference among RTX patients for i.v. drug administration every 6-9 months over other methods of administration.

Background: Well-established gender differences in the clinical picture of fibromyalgia syndrome (FMS) have been suggested. However, studies on gender differences in demographic and clinical features of FMS have contradictory results. Their significance is limited by the small number of patients included and selection bias of single settings., Objective: The purpose of this study was to compare demographic characteristics (age, family status) and clinical variables (duration of chronic pain and FMS diagnosis, tender point count, number of pain sites, and somatic and depressive symptoms) of male and female patients in different settings (general population, FMS self-help organization, and different clinical settings)., Methods: FMS was diagnosed according to survey criteria in the general population and in the self-help organization setting and by 1990 criteria of the American College of Rheumatology in the clinical settings. Tender point examination was performed according to the manual tender point survey protocol in clinical settings. Somatic and depressive symptoms were assessed by validated questionnaires., Results: A total of 1023 patients (885 female, 138 male) were included in the analysis. Compared with male participants, female participants reported a longer duration of chronic widespread pain (P = 0.009) and time since FMS diagnosis (P = 0.05), and they had a higher tender point count (P = 0.04). There were no gender differences in age, family status, number of pain sites, or somatic and depressive symptoms., Conclusions: We found no relevant gender differences in the clinical picture of FMS. The assumption of well-established gender differences in the clinical picture of FMS could not be supported., (Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.)

Bronchoscopic training courses are an essential part of the education in bronchoscopy for all kinds of specialisations and professions performing such investigations. All aspects of the application should be mentioned during a course. These recommendations are necessary because the number of bronchoscopies performed in the last years has increased due to the increasing number of patients, improved equipment and better availability. Courses should provide the basic knowledge including main points of indications, preconditions for the procedure and decisions of consequence after bronchoscopy. Participants should be trained in the skills of correct handling and performing flexible bronchoscopies in training dummies. Necessary competence requirements on the course instructor are adequate professional qualifications, paedagogic skills and the availability of appropriate teaching material. Quality assurance of the course should be achieved by consequent evaluation. A widely spread field of bronchoscopic applications can improve patient care in many medical specialisations., (© Georg Thieme Verlag KG Stuttgart · New York.)

This report concerns a 43-year-old male plumber with relapsing acute hearing loss on the right side and vertiginous attacks. Magnetic resonance imaging (MRI) was performed twice after otolaryngology and neurological examinations over an interval of 2 months and according to the reports no evidence of an acoustic neuroma was found. Approximately 2 years later a right-sided hourglass-shaped acoustic neuroma 4 mm in diameter was diagnosed with MRI located in the vestibule and the fundus of the internal auditory canal. In retrospect it had also been visible on the earlier MRI. The tumor was resected via the labyrinth and the diagnosis of a vestibular schwannoma was confirmed histologically. The patient brought a lawsuit against the radiologist who carried out both previous MRI examinations with the wrong interpretation. The lawsuit terminated in a settlement between the parties after presentation of the neuroradiological expert opinion.

Objectives: The survey and the Association of the Medical Scientific Societies in Germany (AWMF) criteria had been developed to overcome problems associated with tender point criterion of the American College of Rheumatology (ACR) (lacking validation for clinical diagnosis, inconsistent use by rheumatologists, and nonrheumatologists) for the clinical diagnosis of fibromyalgia syndrome (FMS). We compared the concordance between these 3 criteria., Methods: Consecutive patients of different clinical settings referred for the evaluation of chronic widespread pain or management of established FMS diagnosis were assessed by medical history, a complete physical examination including tender points, and questionnaires [self-constructed symptoms questionnaire, regional pain scale (RPS), Patient Health Questionnaire (PHQ 9 and 15)]. FMS according to AWMF-criteria was diagnosed by the history of widespread pain (axial and all 4 extremities), the symptoms sleep disturbances, fatigue, and feeling of swelling or stiffness of the hands or feet or face (Numeric rating scale >or=1/10 each symptom) and the exclusion of somatic diseases sufficiently explaining the symptoms. FMS according to survey criteria was diagnosed by regional pain scale score >or=8 and fatigue score >or=6/10 on a visual analogue scale., Results: Out of 310 patients, 292 could be analysed. AWMF and ACR were concordant in 86.6%, AWMF and survey criteria were concordant in 78.8% and survey and ACR-criteria were concordant in 79.5% of the cases., Discussion: AWMF, survey, and ACR criteria were moderately concordant. As AWMF and survey criteria do not require tender point examination, these criteria can be used by nonrheumatologists for the clinical diagnosis of FMS.

Background: A guideline for the treatment of fibromyalgia syndrome (FMS) was developed in cooperation with 10 German medical and psychological associations and 2 patient self-help groups., Methods: A systematic literature search including all controlled studies evaluating multicomponent therapy (MT) was performed in the Cochrane Library (1993-12/2006), Medline (1980-12/2006), PsychInfo (1966-12/2006) and Scopus (1980-12/2006). Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. Grading of the strengths of recommendations was done according to the German program for disease management guidelines. Standardized procedures to reach a consensus on recommendations were used., Results: MT is superior to control groups or routine treatment (evidence level 1A) and should be offered to FMS patients (recommendation strength A)., Conclusions: Future studies should consider medication, other co-therapies and comorbidities. MT programs tailored to FMS subgroups should be tested.

Background: A guideline for the treatment and diagnostic procedures for fibromyalgia syndrome (FMS) was developed in cooperation with 10 German medical and psychological associations and 2 patient self-help groups., Methods: A systematic literature search including all controlled studies evaluating physiotherapy, exercise and strength training as well as physical therapies was performed in the Cochrane Collaboration Reviews (1993-12/2006), Medline (1980-12/2006), PsychInfo (1966-12/2006) and Scopus (1980-12/2006). Levels of evidence were assigned according to the classification system of the Oxford Centre for Evidence-Based Medicine. Grading of the strengths of recommendations was done according to the German program for disease management guidelines. Standardized procedures to reach a consensus on recommendations were used., Results: Patient's information at first diagnosis of FMS is strongly recommended (grade A). Patient-centered communication is recommended (grade B). A stepwise treatment approach depending on the adapatation to restrictions in daily life and response to treatment options can be considered (grade C)., Conclusions: The long-term treatment should be based on principles of basic psychosomatic care and shared decision making on treatment options.

Background: Liver transplantation is considered as one of therapeutic approaches to hepatocellular carcinoma (HCC). The present study aims to evaluate the efficacy of various therapeutic options for HCC., Materials and Methods: One hundred twenty patients with known HCC in various tumour stages were evaluated in the present study. Patients were treated either with primary tumour resection, transarterial chemoembolisation (TACE) or liver transplantation (LTx) by an interdisciplinary team., Results: The overall 1-year and 5-year survivals of patients in LTx group were 95 and 57%, respectively, which were significantly higher than those in primary tumour resection group (65 and 33%, P < 0.01) and those in TACE group (44 and 4%, P < 0.01). In parallel, 1-year and 5-year tumour-free survivals of patients in LTx group (75 and 62%) were significantly higher than those in primary tumour resection group (50 and 11%, P < 0.01). There were no significant differences in 1- and 5-year survivals of patients with early tumour stage received LTx or primary tumour resection, whereas patients in advanced tumour stage based on pathological findings of explanted liver significantly benefited from LTx as compared to primary resection., Conclusions: LTx can be a curative approach for patients with advanced HCC without extrahepatic metastasis. However, organ shortage is a major limiting factor in the selection of HCC patients for LTx.

Until the end of World War II, oily extracts from the European mole cricket, Gryllotalpa gryllotalpa Linné, were used for treating nonhealing wounds and burns. In traditional Chinese medicine, extracts from the Chinese mole cricket, Gryllotalpa africana Beauvois, have been used to treat boils, abscesses, and ulcers successfully for over two centuries and are still being used today. The aim of this study was twofold: first, to measure the effect mole cricket extracts have on wound epithelialization and neovascularization, and second, to identify the active compounds in the Chinese and German mole cricket extracts. For the first aim, the hairless mouse ear wound model was used. The findings showed that wounds treated with the mole cricket extracts epithelialized significantly faster than control wounds 12.7+/-0.9 and 13.2+/-1.4 days vs. 16.3+/-2.2 days (mean+/-SD, p<0.05), respectively. While the rate of wound neovascularization was significantly increased in the first 3 days postwounding from that point on, the rate in treated wounds was the same as in controls. To identify the active compounds in the mole cricket extracts, the extracts were fractionated and tested in a foreskin basal keratinocyte cell culture assay. In this assay, the migration of keratinocytes is similar to skin cell migration or reepithelialization in a healing wound. Using this method, we found the active compound in the mole cricket extracts to be linoleic acid methyl ester. All other fatty acid structures that were isolated were found to be inactive.

Despite decreasing mortality rates, morbidity is still high after pancreatic head resection. Comparative data in the United States and Europe show a relationship between hospital volume and mortality. Treatment strategies vary frequently, partially because of the lack of evidence-based data. We performed a multi-institutional analysis in Germany evaluating current numbers, indications, techniques, and complication rates of pancreatic head resection. Questionnaires were completed by seven high-volume surgical departments regarding quantitative and qualitative aspects of pancreatic head resections in the period from 1999 to 2004 (five prospective and two retrospective institutional databases). A total of 1454 pancreatic head resections (944 for malignancy) were reported. Mean annual hospital volume ranged from 14 to 52 (10 to 43 in malignancy). Mortality was between 1.1% and 4.8%, morbidity was between 24% and 46%, and pancreatic leakage was between 9% and 20%. In malignant disease, all centers perform standard lymphadenectomy and regard arterial infiltration as a contraindication for resection. However, the rate of portal vein resection varied from 0% to 28%. No consensus is seen on the type of surgery for malignancy and chronic pancreatitis. After resection for pancreatic cancer less than one fourth of the patients receive adjuvant therapy. The results of our analysis in Germany confirm that pancreatic head resection can be performed with low mortality in specialized units. Variations in indications, operative technique, and perioperative care may demonstrate the lack of evidence-based data and/or personal and institutional experience. The low number of patients receiving adjuvant therapy after resection of pancreatic cancer suggests that more efforts must be made to establish novel adjuvant therapies under randomized study conditions.

The objective of the present study was to assess the physical fitness of patients after apical resection and partial apical pleurectomy for the treatment of primary spontaneous pneumothorax (PSP). Between 1982 and 1999, 58 patients received surgical treatment for PSP in our department. Twelve patients needed bilateral surgical intervention. At an average of 121 months after surgery (range, 16-231 months), the patients underwent follow-up assessments. Information was obtained on the basis of a questionnaire and from clinical examinations, including spirometry/body plethysmography and exercise testing with a bicycle ergometer. High-resolution computed tomography was used to identify postoperative changes of the lung apex. Forty-eight of 58 patients took part in the study, and all were found to be fully fit. High-resolution computed tomography gave evidence of new postoperative fibrocystic processes in 26 of the 31 affected apexes. One recurrence was observed (3.2%). Because apical resection cannot counteract pathogenetic mechanisms underlying parenchymal destruction and the formation of postoperative bullae among patients with a history of PSP, additional treatment of the apical pleura is necessary to prevent recurrences. Our results suggest that the physical fitness of patients with PSP can be completely restored postoperatively.

The use of automated external defibrillator (AED) by persons other than paramedics and emergency medical technicians is advocated by several US- and European organizations. However, at the present time it is still unclear to identify public places with a high incidence of out-of-hospital cardiac arrest. There are few data on the potential impact of public access defibrillators on survival after out-of-hospital cardiac arrest in sporting arenas or water parks. Therefore, we studied prospectively incidence of out-of-hospital cardiac arrest in the LAGO-die Therme in Herne. This is one of the most important swimming parks in Europe and member of the European Waterpark Association EWA. Eight AEDs were placed in the waterpark LAGO-die Therme. The locations where the defibrillators were stored were chosen to make possible a target interval of 60 seconds from collapse to first defibrillation. Twenty waterpark officers were instructed in cardiopulmonary resuscitation and in the use of the AED. During November 16, 2001 and December 31, 2004, 2.05 Mio. visitors were counted in the LAGO. Out-of-hospital cardiac arrest occurred in none of them. AED were used in two visitors with non arrhythmogenic syncope, no shock was delivered. Questionaires were done in 588 visitors (336 males, 252 females, mean age 38+21 years) in 2002 and in 579 visitors (322 males, 257 females, mean age 37+/-25 years) in 2004. In 2002, 77% of the visitors noticed the AED and, therefore, 49% performed more sporting activities. In addition, in 2004, AED was noticed by 480 visitors (83%) and 277 visitors (48%) did more sporting activities. There were no significant differences between 2002 and 2004 (p=ns). Despite no out-of-hospital cardiac arrest in the waterpark during the 3 year follow- up, it seems reasonable to install AED in sporting places with thousands of visitors per year.

Aim: For the surgical therapy of differentiated thyroid cancer precise guidelines are applied by the German medical societies. In a retrospective multicenter study, we investigated the following issues: Are the current guidelines respected? Is there a difference concerning the surgical radicalism and the outcome? Does the perioperative morbidity increase with the higher radicalism of the procedure?, Patients, Methods: Data gained from 102 patients from 17 regional referral hospitals who underwent surgery for thyroid cancer and a following rodioiodine treatment (mean follow up: 42.7 [24-79] months) were analyzed. At least 71 criterias were analyzed in a SPSS file., Results: 46.1% of carcinomas were incidentally detected during goiter surgery. The thyroid cancer (papillary n = 78; follicular n = 24) occurred in 87% unilateral and in 13% bilateral. Papillary carcinomas < 1 cm were detected in 25 cases; in five of these cases (20%) contralateral carcinomas < 1 cm were found. There were significant differences concerning the surgical radicalism: a range from hemithyroidectomy to radical thyroidectomy with lateral neck dissection. Analysis of the histopathologic reports revealed that lymph node dissection was not performed according to guidelines in 55% of all patients. The perioperative morbidity was lower in departments with a high case load. The postoperative dysfunction of the recurrent laryngeal nerve (mean: 7.9% total / 4.9% nerves at risk) variated highly, depending on differences in radicalism and hospitals. Up to now these variations in surgical treatment have shown no differences in their outcome and survival rates, when followed by radioiodine therapy., Conclusion: Current surgical regimes did not follow the guidelines in more than 50% of all cases. This low acceptance has to be discussed. The actual discussion about principles of treatment regarding, the so-called papillary microcarcinomas (old term) has to be respected within the current guidelines.

The inguinal hernia repair continues to be the most common operation in general surgery. Discussing the latest scientific findings, we have prepared this article to present a state-of-the-art approach to the inguinal hernia repair. This approach is used for discussing the general principles of hernia repair in German military hospitals. Quality assurance requires that all hernias be classified during surgery on the basis of a standardized approach for an objective comparison of treatment and outcomes. Our approach to hernia repair considers the age of the patient, the diameter and location of the hernia and whether or not the herniation is recurrent. The Shouldice technique performed under local anesthesia is defined as the standard approach in young patients. The use of prosthetic meshes continues to be the ideal method for repairing large medial fascial defects and recurrent hernias. Endoscopic procedures are particularly suitable for the bilateral repair and recurrent hernias.

Elderly patients are significantly less likely to receive statins than younger patients possibly because of doubts regarding compliance or concerns regarding the increased likelihood of adverse events and drug interactions. Poor compliance can be expected especially in patients suffering from dementia or depression as well as those whose stage of cardiovascular disease exhibits few symptoms. On the other hand, the clinical significance of CHD events is high in the elderly, and 80% of coronary deaths occur in patients aged over 65 years. The average statistical life expectancy of elderly and old patients is often underestimated. The HPS and PROSPER studies showed that statins reduce mortality and morbidity even in very elderly individuals with a high global cardiovascular risk and/or CAD. Patients up to the age of 79 years should be treated according to the same guidelines as younger patients. Statin therapy should only be considered for patients aged 80 years and older who are at a very high risk for cardiovascular events.

Aim: The aim of this cross sectional study was to establish the extent of psychiatric morbidity among homeless men and compare this group with a sample of formerly homeless., Method: [corrected] 82 homeless and a comparison group of 37 formerly homeless were interviewed using a psychopathological interview according to AMDP (Arbeitsgemeinschaft für medizinische Dokumentation) as well as selected modules of the CIDI (Composite International Diagnostic Interview). Diagnoses were established according to ICD-10., Results: The lifetime prevalence of psychiatric disorders was 95.1 %, the current prevalence was 87.8 %. Substance related disorders were the most common group of disorders. In the formerly homeless prevalences were slightly lower., Conclusions: Psychiatric morbidity among the homeless is high. Services have to be tailored to meet the needs of this special group. Formerly homeless continue to need intensive psychiatric input.

Normal sleep consists of 4-5 sleep cycles including light-, deep- and rapid eye-movement sleep. Restoration of physical and psychological function are the main effects of sleep. In most cases, disturbances of normal sleep become clinically evident as problems of initiating and maintaining sleep and/or as increased daytime sleepiness. Approximately 10% of adults suffer from pronounced insomnia, a similar percentage from markedly increased daytime sleepiness. Sleep disorders cause high socio-economic costs due to increased accident risk, cardiovascular sequelae and sick leave. Most of the 88 distinct diagnoses summarized in the international classification of sleep disorders can be differentiated and managed according to patients history. In patients with severe daytime sleepiness - sleep disordered breathing being the most frequent cause - the diagnostic evaluation and treatment in the sleep laboratory is required. Effective therapeutic strategies are available for many sleep disorders. According to the underlying disorder, treatment includes a variety of measures like life style changes, differentiated medical treatment and the use of nasally applied positive pressure in patients suffering from sleep disordered breathing.

Aim: The standard treatment for patients with clinically resectable rectal cancer is surgery. Postoperative radiochemotherapy (RCT) is recommended for advanced disease (pT3/4 or pN+). In recent years, encouraging results of pre-operative radiotherapy have been reported. This prospective randomized phase-III-trial (CAO/ARO/AIO-94) compares the efficacy of neoadjuvant RCT to standard postoperative RCT. We report on the design of the study and first results with regard to toxicity of RCT and postoperative morbidity., Patients and Methods: Patients with locally advanced operable rectal cancer (uT3/4 or uN+, Mason CS III/IV) were randomly assigned to pre or postoperative RCT: A total dose of 50.4 Gy (single dose 1.8 Gy) was applied to the tumour and the pelvic lymph nodes. 5-FU (1000 mg/m2/d) was administered concomitantly in the 1th and 5th week of radiation as 120 h-continuous infusion. Four additional cycles of 5-FU-chemotherapy (500 mg/m2/d, i.v.-bolus) were applied. RCT was identical in both arms except for a small-volume boost of 5.4 Gy postoperatively. The time interval between RCT and surgery was 4-6 weeks in both arms. Techniques of surgery were standardized and included total mesorectal excision. Primary endpoints of the study are 5-year survival and local and distant control. Secondary endpoints include the rate of curative (R0) resection and sphincter saving procedures, toxicity of RCT, surgical complications and quality of life., Results: As of July 2002, 805 patients were randomized from 26 participating institutions. Acute toxicity (WHO) of RCT was low, with less than 15% of patients experiencing grade 3 or higher toxicity: The principal toxicity was diarrhea, with 12% in the postoperative RCT-arm and 11% in the pre-operative RCT-arm having grade 3-, and 1% in either arm having grade 4-diarrhea. Erythema, nausea and leukopenia were the next common toxicities, with less than 3% of patients in either arm suffering grade 3 or greater leukopenia or nausea. Postoperative complication rates were similar in both arms, with 12% (postop. RCT) and 12% (pre-op. RCT) of patients, respectively, suffering from anastomotic leakage, 3% (postop. RCT) and 3% (pre-op. RCT) from postoperative bleeding, and 6% (postop. RCT) and 4% (pre-op. RCT) from delayed wound healing., Conclusion: The patient accrual to the trial is satisfactory. Neoadjuvant RCT is well tolerated and bears no higher risk for postoperative morbidity.

Objective: The purpose of this study was to compare the judgment of intravascular volume based either on conventional monitoring or on the data of COLD measurement., Design: Single-blinded, observational study., Setting: Intensive care unit (ICU)., Patients: Ten consecutive patients after upper gastrointestinal tract surgery for carcinoma., Measurements and Results: Judgments ( n=59) about intravascular volume (hypo-, iso- or hypervolemic) were given twice a day until the 2nd postoperative day by two physicians. Physician A's judgment was based on conventional monitoring and physician B's judgment on COLD monitoring. Both were blinded for each other's judgment. The inter-rater agreement between A and B was analyzed using the weighted kappa statistic. Both physicians gave a recommendation about the volume therapy during the following 12 h. The therapeutic regimen, including volume therapy, was defined by physician A. The inter-rater-agreement regarding intravascular volume was poor (overall weighted kappa =0.095). The sum of absolute differences between A and B in their recommendation about infusion administration reached a median of 4,875 ml per patient., Conclusions: The poor inter-rater agreement between the two physicians and the consecutive difference in the infusion therapy may have clinical consequences and should be evaluated in further studies. These data cannot confirm which decision strategy should be preferred.

The course in Gastrointestinal Surgery (GISC) aims at teaching and training resection, reconstruction and suture techniques of the upper gastrointestinal tract. Prior to, after and 5 years following the first course, participants were asked to answer a questionnaire requesting information regarding the adequacy of surgical training in their residency program and how much they had benefited from the GISC. While 1/3 of the participants described the surgical training during their residency as inadequate, more than 90% benefited from the GISC. Although the single-layer-continuous suture technique was implemented by only 8% of the participating surgeons, other techniques such as cross-section gastroenterostomy were accepted by 38%. Only 7% of the participants rejected these new techniques, while 41% of the senior surgeons at home could not be convinced. Besides the teaching of new techniques, participants benefited above all from the repetitive training in surgical procedures.

Unlabelled: Care of chronic wounds is of enormous medical, social and economic importance. Nevertheless there is a lack of epidemiological and economical data. A network of ten wound care centers was created and data were documented in a new computerized wound documentation system., Methods: Treatment was performed according to a comprehensive and standardized wound care protocol. The new documentation system is a network-capable solution. Digital images and planimetry as well as patient and wound related data are recorded., Results: During the first year the ten centers treated and documented already 3281 wounds. There is a wide spectrum of different chronic wounds treated in the participating centers. Despite of long wound duration of several wounds with a median of 5 weeks (range 0-62 years), the healing rate was 80% within 455 days., Conclusion: Large amounts of data can be collected and scientifically evaluated in the wound net. This is realized by a new computerized documentation system, which was integrated into the clinical routine and enables clear and standardized documentation. Therefore even large multicenter therapy studies may be performed easily in the wound net and economical data could be collected.

The study of medicine in Germany is in need of reform. Oversubscribed courses, the lack of practical reference, scarce patient contact and cancelled lessons define the educational landscape for many students. Since at present we cannot carry out global reforms, the quality of medical education is highly dependent on the commitment of those responsible in the individual institution. The aim of the revised surgical curriculum in Göttingen is to demonstrate how medical education with a high didactic level including multimedia teaching can be realised despite large student numbers. Duties both in patient care and education are coordinated through integrated organisation. Educational content and structure are made transparent by online guidebooks. In the surgical examination course and the practical course in surgery, patient-oriented tuition takes place consistently in small groups. The Teaching Studio provides additional aids such as interactive CD-ROMs, online research, textbooks, ultrasound equipment, examination and suturing dummies. Curriculum-relevant information, including the weekly case examples and instruction guides for clinical practical experience, is presented on an Internet website. Constant evaluation of the curriculum not only documents student motivation, but also serves to improve the educational concepts on a continuous basis. On completion of the practical course in surgery, 65% of participants maintain that they have reached the defined learning objectives "well" or "very well" (prior to reform only 17%). In the summer semester 2000, 46% of students gave top marks in the practical course in surgery with respect to tuition in patient contact. The results of the evaluations verify the positive feedback from the student body.

The research activities of the Forschungszentrum Karlsruhe on minimally-invasive surgery (MIS) have for several years improved techniques and instrumentation for different types of MIS. Many types of instruments and robotic devices have been developed and new techniques implemented. In this paper we present the most recent results from our different projects, such as endoscopic heart surgery, tracking systems, a camera guidance device, telemanipulator systems, minimally-invasive breast biopsy in closed-bore MRI, endoscopic training simulators and developments using smart materials (e.g. Nitinol).

The Medical Advisory Service of the Health Insurance in the area of the Northern Rhine (MDK Nordrhein) has set up an internal concept for quality management since 1998. This concept includes the installation and performance of quality circles. Staff members were internally qualified as "presenters". They worked out principles for quality circles of the MDK North Rhine which were implemented as binding basic rules by the managing conference of the MDK. The principles will be presented in detail.