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Background: Approximately 30% of the patients with primary breast cancer who have no axillary lymph node involvement (i.e., lymph node negative) at the time of surgery will relapse within 10 years; 10%-20% of the patients with distant metastases will be lymph node negative at surgery. Axillary lymph node dissection, as a surgical procedure, is associated with frequent complications. A possible alternative to nodal dissection in terms of prognosis may be the immunocytochemical detection of tumor cells in bone marrow.Purpose: In a prospective study, the value of tumor cell detection (TCD) in bone marrow was compared with axillary lymph node dissection in the prognosis of primary breast cancer after surgery.Methods: Data from 727 patients with primary, operable breast cancer were included in the analysis. All patients had surgery, including axillary lymph node dissection, from May 1985 through July 1994 at the Women's Hospital of the University of Heidelberg (Federal Republic of Germany). Bone marrow aspiration at two sites on each anterior iliac crest was performed immediately after surgery while the patients were under general anesthesia. Most patients received some type of systemic adjuvant therapy. The monoclonal antibody 2E11, directed against the polymorphic epithelial mucin TAG12, was used to detect tumor cells in bone marrow samples. The association of TCD with recognized prognostic indicators was evaluated by means of chi-squared tests. Survival without the development of distant metastases (i.e., distant disease-free survival) and overall survival were estimated by use of the Kaplan-Meier method; the logrank test was used to compare survival curves. A multivariate Cox regression analysis with stratification according to adjuvant treatment type was used to assess the independent prognostic value of TCD in bone marrow in relation to other variables. Reported P values are two-sided.Results: Tumor cells were detected in the bone marrow of 203 (55%) of 367 lymph node-positive patients and in 112 (31%) of 360 lymph node-negative patients. TCD was associated with larger tumors (P < .001), lymph node involvement (P = .001), and higher tumor grade (i.e., more undifferentiated) (P = .002). After a median follow-up of 36 months, patients with tumor cells in their bone marrow experienced reduced distant disease-free survival and overall survival (both P values < .001). TCD was an independent prognostic indicator for both distant disease-free survival and overall survival that was superior to axillary lymph node status, tumor stage, and tumor grade. Among patients with tumors less than 2 cm in diameter, TCD was the most powerful predictor of outcome.Conclusions and Implications: TCD in the bone marrow of patients with breast cancer is a valuable prognostic tool associated with negligible morbidity. Prospective randomized studies should be performed to determine whether TCD might replace axillary lymph node dissection in a defined subgroup of patients with small tumors. [ABSTRACT FROM AUTHOR]

Aims Patient time costs have been described to be substantial; however, data are highly limited. We estimated patient time costs attributable to outpatient and inpatient care in study participants with diagnosed diabetes, previously undetected diabetes, impaired glucose regulation and normal glucose tolerance. Methods Using data of the population-based KORA S4 study (55-74 years, random sample of n = 350), we identified participants' stage of glucose tolerance by oral glucose tolerance test. To estimate mean patient time costs per year (crude and standardized with respect to age and sex), we used data regarding time spent with ambulatory visits including travel and waiting time and with hospital stays (time valued at a 2011 net wage rate of €20.63/h). The observation period was 24 weeks and data were extrapolated to 1 year. Results Eighty-nine to 97% of participants in the four groups (diagnosed diabetes, undetected diabetes, impaired glucose regulation and normal glucose tolerance.) had at least one physician contact and 4-14% at least one hospital admission during the observation period. Patient time [h/year (95% CI)] was 102.0 (33.7-254.8), 53.8 (15.0-236.7), 59.3 (25.1-146.8) and 28.6 (21.1-43.7), respectively. Age-sex standardized patient time costs per year (95% CI) were €2447.1 (804.5-6143.6), €880.4 (259.1-3606.7), €1151.6 (454.6-2957.6) and €589.2 (435.8-904.8). Conclusions Patient time costs were substantial-even higher than medication costs in the same study population. They are higher in participants with diagnosed diabetes, but also in those with undetected diabetes and impaired glucose regulation compared with those with normal glucose tolerance. Research is needed in larger populations to receive more precise and certain estimates that can be used in health economic evaluation. [ABSTRACT FROM AUTHOR]

Background: Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings.Objective: We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP).Design: This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m(-2)) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY).Results: The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31,663, 24,996 and 51,571.Conclusion: The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem. [ABSTRACT FROM AUTHOR]

Aim Our objective was to test the hypothesis that the prevalence of Type 2 diabetes increases with increasing regional deprivation even after controlling for individual socio-economic status. Methods We pooled cross-sectional data from five German population-based studies. The data set contained information on n = 11 688 study participants (men 50.1%) aged 45-74 years, of whom 1008 people had prevalent Type 2 diabetes (men 56.2%). Logistic multilevel regression was performed to estimate odds ratios (OR) and 95% confidence intervals (CI) for diabetes prevalence. We controlled for sex, age and lifestyle risk factors, individual socio-economic status and regional deprivation, based on a new small-area deprivation measure, the German Index of Multiple Deprivation. Results Adjusted for sex, age, body mass index (BMI), physical activity, smoking status and alcohol consumption, the prevalence of Type 2 diabetes showed a stepwise increase in risk with increasing area deprivation [OR 1.88 (95% CI 1.16-3.04) in quintile 4 and OR 2.14 (95% CI 1.29-3.55) in quintile 5 compared with the least deprived quintile 1], even after controlling for individual socio-economic status. Focusing on individual socio-economic status alone, the risk of having diabetes was significantly higher for low compared with medium or high educational level [OR 1.46 (95% CI 1.24-1.71)] and for the lowest compared with the highest income group [OR 1.53 (95% CI 1.18-1.99)]. Conclusion Regional deprivation plays a significant part in the explanation of diabetes prevalence in Germany independently of individual socio-economic status. The results of the present study could help to target public health measures in deprived regions. [ABSTRACT FROM AUTHOR]

In comparison with essential hypertension, primary aldosteronism (PA) is associated with an increased risk of cardiovascular morbidity. To date, no data on mortality have been published. We assessed mortality of patients treated for PA within the German Conn's registry and identified risk factors for adverse outcome in a case-control study. Patients with confirmed PA treated in 3 university centers in Germany since 1994 were included in the analysis. All of the patients were contacted in 2009 and 2010 to verify life status. Subjects from the population-based F3 survey of the Cooperative Health Research in the Region of Augsburg served as controls. Final analyses were based on 600 normotensive controls, 600 hypertensive controls, and 300 patients with PA. Kaplan-Meyer survival curves were calculated for both cohorts. Ten-year overall survival was 95% in normotensive controls, 90% in hypertensive controls, and 90% in patients with PA (P value not significant). In multivariate analysis, age (hazard ratio, 1.09 per year [95% CI, 1.03-1.14]), angina pectoris (hazard ratio, 3.6 [95% CI, 1.04-12.04]), and diabetes mellitus (hazard ratio, 2.55 [95% CI, 1.07-6.09]) were associated with an increase in all-cause mortality, whereas hypokalemia (hazard ratio, 0.41 per mmol/L [95% CI, 0.17-0.99]) was associated with reduced mortality. Cardiovascular mortality was the main cause of death in PA (50% versus 34% in hypertensive controls; P<0.05). These data indicate that cardiovascular mortality is increased in patients treated for PA, whereas all-cause mortality is not different from matched hypertensive controls. [ABSTRACT FROM AUTHOR]

Background and aims:In a population-based cohort study with older subjects and without specific interventions, we investigated the impact of body mass index (BMI) and BMI change (as well as waist circumference and change of waist circumference) on reversion from prediabetes to normal glucose tolerance (NGT) and on long-term persistence of NGT.Materials and methods:Oral glucose tolerance tests were conducted at baseline and at follow-up in a cohort study in Southern Germany (KORA S4/F4; 1223 subjects without diabetes aged 55-74 years at baseline in 1999-2001; 887 subjects (73%), of whom 436 had prediabetes at baseline, participated in the follow-up 7 years later).Results:BMI reduction, but not initial BMI, predicted reversion from prediabetes to NGT. The odds ratio (OR) for returning to NGT was 1.43 (95% CI: 1.18-1.73) for a BMI decrease of 1 kg m−2, after adjustment for age, sex, baseline glucose values and lifestyle factors. Initial BMI had no effect on reversion to NGT (OR=0.98, 95% CI: 0.91-1.06, per kg m−2). Persistence of NGT was associated with baseline BMI (OR=0.94, 95% CI: 0.88-0.998) and BMI reduction (OR=1.16, 95% CI: 1.02-1.33, per decrease by 1 kg m−2). For waist circumference and change of waist circumference similar results were obtained.Conclusion:In older adults, weight loss strongly increased the chances of returning from prediabetes to NGT irrespective of initial BMI. Long-term persistence of NGT depended both on initial BMI and on BMI change. [ABSTRACT FROM AUTHOR]

Diabet. Med. 29, 646-653 (2012) Abstract Aims To estimate population values of health-related quality of life (HRQL) in subjects with and without Type 2 diabetes mellitus across several large population-based survey studies in Germany. Systematic differences in relation to age and sex were of particular interest. Methods Individual data from four population-based studies from different regions throughout Germany and the nationwide German National Health Interview and Examination Survey (GNHIES98) were included in a pooled analysis of primary data ( N = 9579). HRQL was assessed using the generic index instrument SF-36 (36-item Short Form Health Survey) or its shorter version, the SF-12 (12 items). Regression analysis was carried out to examine the association between Type 2 diabetes and the two component scores derived from the SF-36/SF-12, the physical component summary score (PCS-12) and the mental component summary score (MCS-12), as well as interaction effects with age and sex. Results The PCS-12 differed significantly by −4.1 points in subjects with Type 2 diabetes in comparison with subjects without Type 2 diabetes. Type 2 diabetes was associated with significantly lower MCS-12 in women only. Higher age was associated with lower PCS-12, but with an increase in MCS-12, for subjects with and without Type 2 diabetes. Conclusions Pooled analysis of population-based primary data offers HRQL values for subjects with Type 2 diabetes in Germany, stratified by age and sex. Type 2 diabetes has negative consequences for HRQL, particularly for women. This underlines the burden of disease and the importance of diabetes prevention. Factors that disadvantage women with Type 2 diabetes need to be researched more thoroughly. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Diabet. Med. 27, 1116–1123 (2010) Background The aim was to derive Type 2 diabetes prediction models for the older population and to check to what degree addition of 2-h glucose measurements (oral glucose tolerance test) and biomarkers improves the predictive power of risk scores which are based on non-biochemical as well as conventional clinical parameters. Methods Oral glucose tolerance tests were carried out in a population-based sample of 1353 subjects, aged 55–74 years (62% response) in Augsburg (Southern Germany) from 1999 to 2001. The cohort was reinvestigated in 2006–2008. Of those individuals without diabetes at baseline, 887 (74%) participated in the follow-up. Ninety-three (10.5%) validated diabetes cases occurred during the follow-up. In logistic regression analyses for model 1, variables were selected from personal characteristics and additional variables were selected from routinely measurable blood parameters (model 2) and from 2-h glucose, adiponectin, insulin and homeostasis model assessment of insulin resistance (HOMA-IR) (model 3). Results Age, sex, BMI, parental diabetes, smoking and hypertension were selected for model 1. Model 2 additionally included fasting glucose, HbA1c and uric acid. The same variables plus 2-h glucose were selected for model 3. The area under the receiver operating characteristic curve significantly increased from 0.763 (model 1) to 0.844 (model 2) and 0.886 (model 3) ( P < 0.01). Biomarkers such as adiponectin and insulin did not improve the predictive abilities of models 2 and 3. Cross-validation and bootstrap-corrected model performance indicated high internal validity. Conclusions This longitudinal study in an older population provides models to predict the future risk of Type 2 diabetes. The OGTT, but not biomarkers, improved discrimination of incident diabetes. [ABSTRACT FROM AUTHOR]

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims To determine the incidence of Type 2 diabetes in an elderly population in Germany and its association with clinical and lifestyle factors. Methods Oral glucose tolerance tests (OGTT, World Health Organization criteria) were carried out in a random sample of 1353 subjects (age group 55–74 years; 62% response) in Augsburg (Southern Germany) (1999–2001). The cohort was re-investigated in 2006–2008. Of those individuals without diabetes (baseline), 887 (74%) participated in the follow-up. Results Ninety-three (10.5%) developed diabetes during the 7-year follow-up period {standardized incidence rates [95% confidence interval (CI)] per 1000 person-years: total 15.5; 12.6, 19.1; men 20.2; 15.6, 26.1; women 11.3; 7.9, 16.1}. In both sexes, those who developed diabetes were slightly older, were more obese, had a more adverse metabolic profile (higher glucose values, HbA1c, fasting insulin, uric acid, and triglycerides) and were more likely to have hypertension at baseline than were participants remaining free of diabetes ( P < 0.05). On stepwise logistic regression, age, parental diabetes, body mass index, uric acid, current smoking, HbA1c and fasting and 2-h glucose (OGTT) were strong predictors of diabetes incidence. The risk of diabetes was higher in subjects with isolated impaired glucose tolerance (odds ratio 8.8; 95% CI 5.0, 15.6) than in isolated impaired fasting glucose (4.7; 2.2, 10.0), although the difference did not reach statistical significance. Conclusions For the first time, we have estimated the incidence of Type 2 diabetes in an elderly German cohort and demonstrated that it is among the highest in Europe. The OGTT appears to be useful in identifying individuals with high Type 2 diabetes risk. Our results support a role of smoking in the progression to diabetes. [ABSTRACT FROM AUTHOR]