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Icks A.,Heinrich Heine University Düsseldorf | Scheer M.,Heinrich Heine University Düsseldorf | Morbach S.,Marienkrankenhaus | Genz J.,Heinrich Heine University Düsseldorf | And 4 more authors.
Diabetes Care | Year: 2011

OBJECTIVE-To estimate the impact of diabetes on mortality in patients after first major lower extremity amputation (LEA). RESEARCH DESIGN AND METHODS-Using claims data of a nationwide statutory health insurance, we assessed all deaths in a cohort of all 444 patients with a firstmajor LEA since 2005 (71.8% male; mean age 69.1 years; 58.3% diabetic; 43% with amputation above the knee) up to 2009. Using Cox regression, we estimated the time-dependent hazard ratios to compare patients with and without diabetes. RESULTS-The cumulative 5-year mortality was 68% in diabetic and 59% in nondiabetic individuals. In the first course, mortality was lower in diabetic compared with nondiabetic patients. Later, the diabetes risk increased yielding crossed survival curves after 2 to 3 years (time dependency of diabetes; P = 0.003). Age- and sex-adjusted hazard ratios for diabetes were as follows: 0-30 days: 0.50 [95% CI 0.31-0.84]; 31-60 days: 0.60 [0.25-1.41]; 61 days to 6 months: 0.75 [0.38-1.48]; >6-12 months: 1.27 [0.63-2.53]; >12-24 months: 1.65 [0.88-3.08]; >24-36 months: 2.02 [0.80-5.09]; and >36-60 months: 1.91 [0.70-5.21]. The pattern was similar in both sexes. In the full model, significant risk factors for mortality were age (1.05; 1.03-1.06), amputation above the knee (1.50; 1.16-1.94), and quartile category 3 or 4 of the number of prescribed medications (1.64; 1.12-2.40 and 1.76; 1.20-2.59). Further adjustment for comorbidity did not alter the results. CONCLUSIONS-In this population-based study, we found a time-dependent mortality risk of diabetes following first major LEA, which may be in part a result of a healthier lifestyle in diabetic patients or the access to specific treatment structures in diabetic individuals. © 2011 by the American Diabetes Association.

Hoffmann F.,University of Bremen | Claessen H.,Heinrich Heine University Düsseldorf | Morbach S.,Marienkrankenhaus | Waldeyer R.,Heinrich Heine University Düsseldorf | And 2 more authors.
Journal of Diabetes and its Complications | Year: 2013

Aims To compare direct medical costs 1 year before up to 3 years after first major lower extremity amputation (LEA) between patients with and without diabetes. Methods We used health insurance claims data and included patients with a first major LEA between 2005 and 2009. Costs for hospitalization, rehabilitation, outpatient care, outpatient drug prescriptions, non-physician services, durable medical equipment and long-term care were assessed. We estimated cost ratios (CR) for diabetes status using generalized linear models adjusted for age, sex, amputation level, care dependency as well as observation time and mortality within the corresponding period and costs before LEA. Results We included 444 patients with first major LEA (58.3% had diabetes), 71.8% were male and the average age was 69.1 years. Total mean costs for 1 year before LEA were higher in patients with diabetes (24,504 vs. 18,961 Euros), which was also confirmed by the multivariate analysis (CR: 1.27; 95% CI: 1.06-1.52). Costs up to 24 weeks after LEA were virtually the same in both groups (36,686 vs. 35,858 Euros), but thereafter differences increase again with higher costs for diabetics. Costs for 3 years after LEA were 115,676 vs. 92,862 Euros, respectively (CR: 1.26; 95% CI: 1.12-1.42). Hospitalizations accounted for more than 50% of total costs irrespective of diabetes status and period. Conclusions Costs up to 24 weeks after first major LEA are mainly driven by the amputation itself irrespective of diabetes. Thereafter, costs for diabetic patients were higher again, which underlines the importance of studying long-term costs. © 2013 Elsevier Inc.

Icks A.,Heinrich Heine University Düsseldorf | Glaeske G.,University of Bremen | Claessen H.,Heinrich Heine University Düsseldorf | Hoffmann F.,University of Bremen | Morbach S.,Marienkrankenhaus
Diabetes Care | Year: 2012

OBJECTIVE - To estimate the impact of diabetes on mortality in patients after first stroke event. RESEARCH DESIGN AND METHODS - Using claims data from a nationwide statutory health insurance fund (Gmünder ErsatzKasse), we assessed all deaths in a cohort of 5,757 patients with a first stroke between 2005 and 2007 (69.3% male, mean age 68.1 years, 32.2% with diabetes) up to 2009. By use of Cox regression, we estimated time-dependent hazard ratios (HRs) to compare patients with and without diabetes stratified by sex. RESULTS - The cumulative 5-year mortality was 40.0 and 54.2%in diabetic men and women, and 32.3 and 38.1% in their nondiabetic counterparts, respectively. In males, mortality was significantly lower in diabetic compared with nondiabetic patients in the first 30 days (multiple-adjusted HR 0.67 [95% CI 0.53-0.84]). After approximately a quarter of a year, the diabetes risk increased, yielding crossed survival curves. Later on, mortality risk tended to be similar in diabetic and nondiabetic men (1-2 years: 1.42 [1.09-1.85]; 3-5 years: 1.00 [0.67-1.41]; time dependency of diabetes, P = 0.008). In women, the pattern was similar; however, time dependency was not statistically significant (P = 0.89). Increasing age, hemorrhagic stroke, renal failure (only in men), levels of care dependency, and number of prescribed medications were significantly associated with mortality. CONCLUSIONS - We found a time-dependent mortality risk of diabetes after first stroke in men. Possible explanations may be type of stroke or earlier and more intensive treatment of risk factors in diabetic patients. © 2012 by the American Diabetes Association.

Kolodziej M.A.,University of Marburg | Koblitz S.,Marienkrankenhaus | Nimskmskmsky C.,University of Marburg | Hellwig D.,International Neuroscience Institute
Neurosurgical Focus | Year: 2011

Object: The goal of this study was to evaluate the incidence and mechanisms of head injury during soccer games and to describe the results after spontaneous resolution of symptoms or after treatment. Methods: In a retrospective study from 2005, records on 451 players from the German Soccer Association who had suffered various injuries were collected. The study used a questionnaire in which the player described the accident and the playing situation as well as the clinical course after trauma. This questionnaire also included information about the physical symptoms of the players and the length of their rehabilitation. Two groups were formed: one with head injuries (case group), and the other with injuries of other body parts (control group). Results: Of the injuries reported, 108 (23.9%) were related to the head, 114 (25.3%) to the knee, 58 (13%) to the ankle, 56 (12%) to the calf, and 30 (7%) to the shoulder. The areas of the head most frequently involved were the facial and occipital regions. In the head injury group, the head duel was the most common playing action to lead to trauma. In those cases, the body part that hit the injured player was the elbow, arm, or head of the opponent. The most common playing situation was combat in the penalty area. The median hospitalization time after the trauma was 2 days for the case group and 5 days for the control group. The rehabilitation time for the case group was also shorter (median 6.5 days) than for the control group (median 30 days). Conclusions: Trivial head injuries in soccer can have a long and complicated course. Nevertheless, the temporary disability is shorter in most cases than for players with injuries to other parts of the body. Modifying the rules of play would be necessary to reduce the incidence of head trauma.

Waldmann J.,University of Marburg | Patsalis N.,University of Marburg | Patsalis N.,University of Cologne | Fendrich V.,University of Marburg | And 7 more authors.
Langenbeck's Archives of Surgery | Year: 2012

Background: To evaluate the role of somatic TP53 mutations and to correlate somatic and germline mutations with results of immunostaining, a large cohort of ACC patients was analyzed. Patients and methods: Patients with ACC who underwent potential curative surgery at the authors' department were screened for TP53 somatic and germline mutations in exons 5, 6, 7, 8, and 10 by DHPLC analysis. Aberrant samples were further analyzed by direct sequencing. Immunostaining was performed on corresponding paraffin sections in all patients. Complete clinical and follow-up data were correlated with the status of TP53. Results: Thirty ACC patients were included. Four of 30 patients showed aberrant DHPLC configuration and direct sequencing confirmed 2 (7%) germline mutations (R337H, R248W), 1 (3%) somatic mutation (R213X), and 1 (3%) noncoding polymorphism (g.17708 A>T). The only patient with a positive family history harbored a TP53 mutation. Tumors of the three patients with mutations showed aberrant p53 expression in more than 10% of cells by immunostaining, compared to only 3 of 27 patients without mutations (p=0.009). Aberrant p53 expression (>5%) was detected in 12/30 (40%) ACCs. The latter was associated with an increased Ki67 and van Slooten index (p≤0.001; p= 0.020). Disease-free survival decreased significantly in patients with aberrant p53 IHC of more than 5% of cells (65.7±12.4 vs. 26.6±8.7 months; p=0.043 log rank test). Conclusions Patients with ACC revealed aberrant expression of p53 in 40%, and mutations were identified in 25% of these patients. Therefore aberrant p53 expression should be considered an indicator for genetic testing. A subgroup of apparently sporadic ACC is caused by TP53 germline mutations, and family history is a strong indicator for p53 germline mutations. © Springer-Verlag 2011.

Palm F.,Stadtisches Klinikum Ludwigshafen | Urbanek C.,Stadtisches Klinikum Ludwigshafen | Wolf J.,Stadtisches Klinikum Ludwigshafen | Buggle F.,Stadtisches Klinikum Ludwigshafen | And 7 more authors.
Cerebrovascular Diseases | Year: 2012

Background: Stroke etiology in ischemic stroke guides preventive measures and etiological stroke subgroups may show considerable differences between both sexes. In a population-based stroke registry we analyzed etiological subgroups of ischemic stroke and calculated sex-specific incidence and mortality rates. Methods: The Ludwigshafen Stroke Study is a prospective ongoing population-based stroke registry. Multiple overlapping methods of case ascertainment were used to identify all patients with incident stroke or transient ischemic attack. Modified TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria were applied for subgroup analysis in ischemic stroke. Results: Out of 626 patients with first-ever ischemic stroke in 2006 and 2007, women (n = 327) were older (73.5 ± 12.6 years) than men (n = 299; 69.7 ± 11.5 years; p < 0.001). The age-adjusted incidence rate of ischemic stroke was significantly higher in men (1.37; 95% CI 1.20-1.56) than in women (1.12; 95% CI 0.97-1.29; p = 0.04). Cardioembolism (n = 219; 35.0%), small-artery occlusion (n = 164; 26.2%), large-artery atherosclerosis (n = 98; 15.7%) and 'probable atherothrombotic stroke' (n = 84; 13.4%) were common subgroups of ischemic stroke. Stroke due to large-artery atherosclerosis (p = 0.025), current smoking (p = 0.008), history of smoking (p < 0.001), coronary artery disease (p = 0.0015) and peripheral artery disease (p = 0.024) was significantly more common in men than in women. Overall, 1-year survival was not different between both sexes; however, a significant age-sex interaction with higher mortality in elderly women (>85 years) was detected. Conclusions: Cardioembolism is the main source for ischemic stroke in our population. Etiology of ischemic stroke differs between sexes, with large-artery atherosclerotic stroke and associated diseases (coronary artery disease and peripheral artery disease) being more common in men. Copyright © 2011 S. Karger AG, Basel.

Kreissl M.C.,University of Würzburg | Schirbel A.,University of Würzburg | Fassnacht M.,University of Würzburg | Haenscheid H.,University of Würzburg | And 9 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: Imaging with [123I]iodometomidate ([ 123I]IMTO) has been shown to diagnose adrenocortical lesions with high sensitivity and specificity. Objective: Our objective was to evaluate the clinical utility of [123I]IMTO imaging in adrenocortical carcinoma (ACC). Design: We conducted a prospective monocentric diagnostic study and a prospective case series at a single tertiary referral center. Patients and Interventions: Fifty-eight patients with histologically confirmed ACC, all European Network for the Study of Adrenal Tumors stage IV (with distant metastases), received 185 MBq [123I]IMTO. Sequential planar whole-body scans until 24 hours post injection and single photon emission computed tomography/computed tomography (SPECT/CT) hybrid imaging 4 to 6 hours post injection were performed. Main Outcome Measures: Outcome measures included uptake of [123I]IMTO in ACC lesions, sensitivity and specificity of [123I]IMTO imaging compared with conventional imaging, and number of patients eligible for [131I]IMTO therapy. Results: Of 430 lesions detected by conventional imaging, 30% showed strong, 8% moderate, and 62% no tracer accumulation. [123I]IMTO detected both primary and metastatic lesions of ACC. However, a substantial percentage of lesions failed to show [123I]IMTO uptake. The overall sensitivity and specificity values were 38% and 100%, respectively. Thirty-four patients (59%) had at least 1 [123I]IMTO-positive lesion. Cortisol and aldosterone secretion by ACC was positively correlated to [123I]IMTO uptake (P = .01); cytotoxic chemotherapy and mitotane treatment presumably did not influence tracer uptake. Twenty-one patients (36.2%) had radiotracer uptake in all lesions ≥2 cmand therefore were potential candidates for targeted systemic radiotherapy with [131I]IMTO. Conclusion: About one-third of patients with ACC show specific retention of [123I]IMTO in metastatic lesions. This study provides support for the conduct of a prospective trial to determine whether the first molecular informed therapy using [131I]IMTO will be of value to patients with metastatic ACC. Copyright © 2013 by The Endocrine Society.

Verde P.E.,Heinrich Heine University Düsseldorf | Ohmann C.,Heinrich Heine University Düsseldorf | Morbach S.,Marienkrankenhaus | Icks A.,Heinrich Heine University Düsseldorf
Statistics in Medicine | Year: 2016

In this paper, we present a unified modeling framework to combine aggregated data from randomized controlled trials (RCTs) with individual participant data (IPD) from observational studies. Rather than simply pooling the available evidence into an overall treatment effect, adjusted for potential confounding, the intention of this work is to explore treatment effects in specific patient populations reflected by the IPD. In this way, by collecting IPD, we can potentially gain new insights from RCTs' results, which cannot be seen using only a meta-analysis of RCTs. We present a new Bayesian hierarchical meta-regression model, which combines submodels, representing different types of data into a coherent analysis. Predictors of baseline risk are estimated from the individual data. Simultaneously, a bivariate random effects distribution of baseline risk and treatment effects is estimated from the combined individual and aggregate data. Therefore, given a subgroup of interest, the estimated treatment effect can be calculated through its correlation with baseline risk. We highlight different types of model parameters: those that are the focus of inference (e.g., treatment effect in a subgroup of patients) and those that are used to adjust for biases introduced by data collection processes (e.g., internal or external validity). The model is applied to a case study where RCTs' results, investigating efficacy in the treatment of diabetic foot problems, are extrapolated to groups of patients treated in medical routine and who were enrolled in a prospective cohort study. © 2016 John Wiley & Sons, Ltd.

Morbach S.,Marienkrankenhaus | Furchert H.,Marienkrankenhaus | Groblinghoff U.,Marienkrankenhaus | Hoffmeier H.,Marienkrankenhaus | And 11 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - There is a dearth of long-term data regarding patient and limb survival in patients with diabetic foot ulcers (DFUs). The purpose of our study was therefore to prospectively investigate the limb and person survival of DFU patients during a follow-up period of more than 10 years. RESEARCH DESIGN AND METHODS - Two hundred forty-seven patients with DFUs and without previous major amputation consecutively presenting to a single diabetes center between June 1998 and December 1999 were included in this study and followed up until May 2011. Mean patient age was 68.8 ± 10.9 years, 58.7% were male, and 55.5%had peripheral arterial disease (PAD). Times to first major amputation and to death were analyzed with Kaplan- Meier curves and Cox multiple regression. RESULTS - A first major amputation occurred in 38 patients (15.4%) during follow-up. All but one of these patients had evidence of PAD at inclusion in the study, and 51.4% had severe PAD [anklebrachial pressure index ≤0.4]). Age (hazard ratio [HR] per year, 1.05 [95% CI, 1.01-1.10]), being on dialysis (3.51 [1.02-12.07]), and PAD (35.34 [4.81-259.79]) were significant predictors for first major amputation. Cumulative mortalities at years 1, 3, 5, and 10 were 15.4, 33.1, 45.8, and 70.4%, respectively. Significant predictors for death were age (HR per year, 1.08 [95% CI, 1.06-1.10]), male sex ([1.18-2.32]), chronic renal insufficiency (1.83 [1.25-2.66]), dialysis (6.43 [3.14-13.16]), and PAD (1.44 [1.05-1.98]). CONCLUSIONS - Although long-term limb salvage in this modern series of diabetic foot patients is favorable, long-term survival remains poor, especially among patients with PAD or renal insufficiency. © 2012 by the American Diabetes Association.

PubMed | Marienkrankenhaus and University of Helsinki
Type: | Journal: Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society | Year: 2016

Since the early 1990s, low long-term survival rates following pancreatic surgery for pancreatic ductal adenocarcinoma have challenged us to improve treatment. In this series, we aim to show improved survival from pancreatic ductal adenocarcinoma during the era of centralized pancreatic surgery.Analysis of all pancreatic resections performed at Helsinki University Hospital and survival of pancreatic ductal adenocarcinoma patients during 2000-2013 were included. Post-operative complications such as fistulas, reoperations, and mortality rates were recorded. Patient and tumor characteristics were compared with survival data.Of the 853 patients undergoing pancreatic surgery, 581 (68%) were pancreaticoduodenectomies, 195 (21%) distal resections, 28 (3%) total pancreatectomies, and 49 (6%) other procedures. Mortality after pancreaticoduodenectomy was 2.1%. The clinically relevant B/C fistula rate was 7% after pancreaticoduodenectomy and 13% after distal resection, and the re-operation rate was 5%. The 5- and 10-year survival rates for pancreatic ductal adenocarcinoma were 22% and 14%; for T1-2, N0 and R0 tumors, the corresponding survival rates were 49% and 31%. Carbohydrate antigen 19-9 >75kU/L, carcinoembryonic antigen >5g/L, N1, lymph-node ratio >20%, R1, and lack of adjuvant therapy were independent risk factors for decreased survival.After centralization of pancreatic surgery in southern Finland, we have managed to enable pancreatic ductal adenocarcinoma patients to survive markedly longer than in the early 1990s. Based on a 1.7-million population in our clinic, mortality rates are equal to those of other high-volume centers and long-term survival rates for pancreatic ductal adenocarcinoma have now risen to some of the highest reported.

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