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Hamburg, Germany

Icks A.,Heinrich Heine University Dusseldorf | Scheer M.,Heinrich Heine University Dusseldorf | Morbach S.,Marienkrankenhaus | Genz J.,Heinrich Heine University Dusseldorf | 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. Source

Kreissl M.C.,University of Wurzburg | Schirbel A.,University of Wurzburg | Fassnacht M.,University of Wurzburg | Haenscheid H.,University of Wurzburg | 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. Source

Icks A.,Heinrich Heine University Dusseldorf | Glaeske G.,University of Bremen | Claessen H.,Heinrich Heine University Dusseldorf | 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. Source

Hoffmann F.,University of Bremen | Claessen H.,Heinrich Heine University Dusseldorf | Morbach S.,Marienkrankenhaus | Waldeyer R.,Heinrich Heine University Dusseldorf | 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. Source

Verde P.E.,Heinrich Heine University Dusseldorf | Ohmann C.,Heinrich Heine University Dusseldorf | Morbach S.,Marienkrankenhaus | Icks A.,Heinrich Heine University Dusseldorf
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. Source

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