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Eating out is often recorded through short-term measurements and the large within-person variability in intakes may not be adequately captured. The present study aimed to understand the effect of measurement error when using eating-out data from one or two 24 h dietary recalls (24hDR), in order to describe intakes and assess associations between eating out and personal characteristics. In a sample of 366 adults from Potsdam, Germany, two 24hDR and a FFQ were collected. Out-of-home intakes were estimated based on either one 24hDR or two 24hDR or the Multiple Source Method (MSM) combining the two 24hDR and the questionnaire. The distribution of out-of-home intakes of energy, macronutrients and selected foods was described. Multiple linear regression and partial correlation coefficients were estimated to assess associations between out-of-home energy intake and participants' characteristics. The mean daily out-of-home intakes estimated from the two 24hDR were similar to the usual intakes estimated through the MSM. The out-of-home energy intake, estimated through either one or two 24hDR, was positively associated with total energy intake, inversely with age and associations were stronger when using the two 24hDR. A marginally significant inverse association between out-of-home energy intake and physical activity at work was observed only on the basis of the two 24hDR. After applying the MSM, all significant associations remained and were more precise. Data on eating out collected through one or two 24hDR may not adequately describe intake distributions, but significant associations between eating out and participants' characteristics are highly unlikely to appear when in reality these do not exist. [ABSTRACT FROM PUBLISHER]

The protection motivation theory (PMT) is a well-known theory of behaviour change. This study tested the applicability of the sub-constructs of threat and coping appraisal in predicting adolescents’ smoking-related behavioural intentions and smoking behaviour longitudinally. Adolescents (N = 494) aged 11–16 years and not currently smoking at baseline participated in the study. Predictive validity of PMT constructs was tested in a path analysis model. Self-efficacy significantly predicted behavioural intention at baseline, which significantly predicted behavioural intention at follow-up, which in turn predicted smoking behaviour at follow-up. The effect of self-efficacy on behavioural intention at follow-up was mediated by behavioural intention at baseline and the effect of self-efficacy on smoking behaviour was mediated by behavioural intention at baseline and follow-up. In conclusion, we found support for one part of the PMT, namely for the predictive validity of the coping appraisal construct self-efficacy in predicting adolescents’ smoking-related behavioural intention and smoking behaviour. These results fail to support the appropriateness of the PMT’s construct threat appraisal in longitudinally predicting adolescents’ smoking as well as the applicability of communicating fear and negative information as preventive interventions for this target group. [ABSTRACT FROM PUBLISHER]

Objectives. The combination of clinical items suggestive of inflammatory back pain has proved useful for early identification of patients with axial SpA (axSpA) in primary care. However, whether HLA B27 contributes to that is unclear, and published recommendations have advised against it. In this study, we reanalysed data of that trial in relation to the HLA B27 results.Methods. Consecutive patients <45 years old (n = 950) with back pain (BP) >2 months presenting to 143 orthopaedists were referred to 36 rheumatologists who made the diagnosis. The predictive value of HLA B27 (n = 298) alone and in combination, including modelling and a two-step strategy, was calculated.Results. Among all patients (mean age 36 years, 52% female, median duration of BP 32 months), 107 had axSpA (36%). Using a simple model, HLA B27 alone performed better than all combinations of clinical items and adding it did not improve likelihood ratios (LRs). Using modelling, two-phase strategies were analysed. Additional items were only relevant in the HLA B27-negative group: improvement by movement, buttock pain and psoriasis. Combining this information revealed the presumably best strategy to predict axSpA in primary care: more than one of these items or HLA B27 need to be present (sensitivity 80.4%, specificity 75.4%, LR+ 3.27 and LR− 0.26).Conclusion. This is the first study to show that patients with axSpA are more reliably identified in primary care by a strategy that includes HLA B27. Because of the two-step approach, the test needs to be performed in only about half of patients with chronic BP. [ABSTRACT FROM PUBLISHER]

Background: The objectives of this study were to estimate and cross-nationally compare the medical costs shared by payers and patients and the distributions of medical costs by cost category. Material and Methods: We estimated the medical costs covered from definitive diagnosis to completion of treatments of early-stage breast cancer and follow-up, assuming almost identical medical care provided in Japan, the UK, and Germany. The analysis was performed from the payer's perspective. Medical costs were calculated by multiplying the unit costs by the number of units consumed, based on assumption case scenarios. The medical costs incurred by payers or patients were estimated according to the cost-sharing and the cost-bearing systems in each country. Results: The total medical costs in Japan were much lower than those in the UK and Germany, and these differences were mainly caused by the low costs of surgery and radiotherapy in Japan. For the base-case scenario, the co-payment in Japan (€ 3,486) was found to be 6.4-fold higher than that in Germany (€ 548). The payers in the European countries paid 2.9-fold more than those in Japan (€ ∼25,000 vs. € 8,627). Conclusion: Our results will be useful for policy makers in considering how to share medical costs and how to allocate limited resources. © 2013 S. Karger GmbH, Freiburg [ABSTRACT FROM AUTHOR]

Different lifestyle patterns across Europe may influence plasma concentrations of B-vitamins and one-carbon metabolites and their relation to chronic disease. Comparison of published data on one-carbon metabolites in Western European regions is difficult due to differences in sampling procedures and analytical methods between studies. The present study aimed, to compare plasma concentrations of one-carbon metabolites in Western European regions with one laboratory performing all biochemical analyses. We performed the present study in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort among 5446 presumptively healthy individuals. Quantile regression was used to compare sex-specific median concentrations between Northern (Denmark and Sweden), Central (France, Germany, The Netherlands and United Kingdom) and Southern (Greece, Spain and Italy) European regions. The lowest folate concentrations were observed in Northern Europe (men, 10·4 nmol/l; women, 10·7 nmol/l) and highest concentrations in Central Europe. Cobalamin concentrations were slightly higher in Northern Europe (men, 330 pmol/l; women, 352 pmol/l) compared with Central and Southern Europe, but did not show a clear north–south gradient. Vitamin B2 concentrations were highest in Northern Europe (men, 22·2 nmol/l; women, 26·0 nmol/l) and decreased towards Southern Europe (Ptrend< 0·001). Vitamin B6 concentrations were highest in Central Europe in men (77·3 nmol/l) and highest in the North among women (70·4 nmol/l), with decreasing concentrations towards Southern Europe in women (Ptrend< 0·001). In men, concentrations of serine, glycine and sarcosine increased from the north to south. In women, sarcosine increased from Northern to Southern Europe. These findings may provide relevant information for the study of regional differences of chronic disease incidence in association with lifestyle. [ABSTRACT FROM PUBLISHER]

Background: There is some controversy regarding the precise role and need for adjuvant therapy in patients with pT1a/pT1bN0 breast cancer, although studies have indicated that a HER2-positive status is one of the most powerful poor prognostic factors. Patients and Methods: We retrospectively evaluated disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) among 960 patients diagnosed between 2000 and 2008 with T1N0 primary breast cancer treated at 3 German centers, and determined prognostic risk factors. Univariate analysis was used to determine associations with potential risk factors. Results: With a median follow-up of 23 months, DFS was 94.8%, DDFS 96.3%, and OS 97.5%. Risk factors for decreased 1-year DFS were: peritumoral lymphatic invasion (L1) (p = 0.031), negative hormone receptor status (p = 0.003), non-use of hormonal therapy (p = 0.001), and a positive HER2 status (p = 0.003). Amongst the HER2-positive patients only 2.7% (n = 1/37) of those treated with trastuzumab had a DFS event compared with 20% (n = 10/50) without trastuzumab. Conclusion: Patients with HER2-positive T1 breast cancer should be considered for inclusion in prospective trials of trastuzumab in combination with chemotherapy to determine the risk-to-benefit ratio and association with other prognostic factors. © 2013 S. Karger GmbH, Freiburg [ABSTRACT FROM AUTHOR]

Background: Adverse effects of single parenthood on children’s health have been reported before. Socio-economic difficulties are discussed as mediating factors. As child health also depends on environmental conditions, we investigated the impact of environmental exposures and socio-economic factors on differences in health outcomes of children with single mothers vs. couple families. Methods: Data on 17 218 pre-school children (47% female) from three cross-sectional surveys conducted during 2004–07 in Germany were analysed. Health and exposure assessment were primarily based on parental report. Effects of socio-economic indicators (maternal education, household income) and environmental factors (traffic load at the place of residence, perceived environmental quality) on associations of four health outcomes (parent-reported health status, asthma, overweight, psychological problems) with single parenthood were determined by logistic regression analyses. Results: Children with single mothers showed an increased risk regarding parent-reported poor health status [boys: odds ratio (OR) 1.39 (95% confidence interval (CI): 1.06–1.82), girls: 1.73 (1.28–2.33)], psychological problems [boys: 1.90 (1.38–2.61), girls: 1.58 (1.03–2.42)], overweight [only boys: OR 1.23 (1.01–1.50) and asthma [only girls: OR 1.90 (1.15–3.15)]. Adjusting for socio-economic factors attenuated the strength of the association of family type with child health. Although environmental factors were associated with most health outcomes investigated and children of single mothers were more often exposed, these environmental factors did not alter the differences between children with single mothers and couple families. Conclusions: The increased health risks of children from single-mother families vs. couple families are partly explained by socio-economic factors, but not by the environmental exposures studied. [ABSTRACT FROM PUBLISHER]

We aimed to investigate the effects of fish oil (FO) supplementation to pregnant women on the maternal and fetal fatty acid profile in plasma and erythrocyte phospholipids (PL) and to identify the best compartment for the assessment of fatty acid status. A multi-centre, double-blind, controlled trial was conducted. Healthy pregnant women from three European centres were randomly assigned to receive from week 20 of gestation until delivery a daily dietary supplement with either FO (500 mg DHA+150 mg EPA), 400 μg 5-methyltetrahydrofolate, both or placebo. Fatty acids in plasma and erythrocyte PL were determined in maternal blood (week 20, week 30 of pregnancy and delivery) and in cord blood (delivery). FO supplementation increased DHA levels in maternal and cord plasma and erythrocyte PL. Higher percentage changes were observed in erythrocyte PL than in plasma PL. There were significant correlations between plasma and erythrocyte fatty acid levels in maternal and cord blood. Significant correlations between maternal and cord fatty acid levels at delivery in plasma and erythrocytes were also observed; however, correlation coefficients were higher for erythrocyte phophatidylethanolamine. FO supplementation increases maternal and fetal DHA status. Both plasma and erythrocytes appear to be suitable to evaluate the fatty acid status of mothers but erythrocytes seem to be a more reliable marker in neonates. [ABSTRACT FROM PUBLISHER]

Previous studies suggest that a low-glycaemic index (LGI) diet may improve insulin sensitivity (IS). As IS has been shown to decrease during refeeding, we hypothesised that an LGI- v. high-GI (HGI) diet might have favourable effects during this phase. In a controlled nutritional intervention study, sixteen healthy men (aged 26·8 (sd 4·1) years, BMI 23·0 (sd 1·7) kg/m2) followed 1 week of overfeeding, 3 weeks of energy restriction and of 2 weeks refeeding at ± 50 % energy requirement (50 % carbohydrates, 35 % fat and 15 % protein). During refeeding, subjects were divided into two matched groups receiving either high-fibre LGI or lower-fibre HGI foods (GI 40 v. 74, fibre intake 65 (sd 6) v. 27 (sd 4) g/d). Body weight was equally regained in both groups with refeeding (mean regain 70·5 (sd 28·0) % of loss). IS was improved by energy restriction and decreased with refeeding. The decreases in IS were greater in the HGI than in the LGI group (group × time interactions for insulin, homeostasis model assessment of insulin resistance (HOMAIR), Matsuda IS index (MatsudaISI); all P< 0·05). Mean interstitial glucose profiles during the day were also higher in the HGI group (ΔAUCHGI-LGI of continuous interstitial glucose monitoring: 6·6 mmol/l per 14 h, P= 0·04). At the end of refeeding, parameters of IS did not differ from baseline values in either diet group (adiponectin, insulin, HOMAIR, MatsudaISI, M-value; all P>0·05). In conclusion, nutritional stress imposed by dietary restriction and refeeding reveals a GI/fibre effect in healthy non-obese subjects. LGI foods rich in fibre may improve glucose metabolism during the vulnerable refeeding phase of a weight cycle. [ABSTRACT FROM PUBLISHER]

Background: Both emotion regulation and impulsivity are core aspects of borderline personality disorder (BPD) pathology. Although both problems may be combined specifically in BPD, few studies to date have investigated the emotional modulation of impulsivity in BPD. Methods: Women with BPD and matched healthy controls performed go/no-go tasks after induction of anger, joy or a neutral mood by vocally presented short stories. Dependent variables were the behavioural results and functional magnetic resonance imaging data. Results: We included 17 women with BPD and 18 controls in our study. No behavioural group differences were found. However, patients with BPD showed stronger activation of the left amygdala and weaker activation of the subgenual anterior cingulate during anger induction than controls. Inhibition in the go/no-go task after anger induction increased activity in the left inferior frontal cortex in controls, but not in women with BPD, who, in turn, showed increased activation in the subthalamic nucleus. Limitations: Findings cannot be generalized to men, and 4 patients were taking antidepressant medication (selective serotonin reuptake inhibitors). In addition, no patient control group was investigated, thus we do not know whether findings are specific to BPD compared with other disorders. Conclusion: Our findings are consistent with the view that a disturbed amygdala-prefrontal network in patients with BPD is compensated by a subcortical loop involving the subthalamic nucleus, leading to normal behavioural inhibition in these patients. [ABSTRACT FROM AUTHOR]

Background: The Patient's Anastrozole Compliance to Therapy (PACT) program is a large randomized study designed to assess whether the provision of educational materials (EM) could improve compliance with aromatase inhibitor therapy in postmenopausal women with early, hormone receptor-positive breast cancer. Patients and Methods: The PACT study presented a large, homogeneous dataset. The baseline analysis included patient demographics and initial treatments and patient perceptions about treatment and quality of life. Results: Overall, 4,923 patients were enrolled at 109 German breast cancer centers/clinics in cooperation with 1,361 office-based gynecologists/oncologists. 4,844 women were randomized 1:1 to standard therapy (n = 2,402) or standard therapy plus EM (n = 2,442). Prior breast-conserving surgery and mastectomy had been received by 76% and 24% of the patients, respectively. Radiotherapy was scheduled for 85% of the patients, adjuvant chemotherapy for 38%. Reflecting the postmenopausal, hormone-sensitive nature of this population, only 285 patients (7%) had received neoadjuvant chemotherapy. Conclusions: A comparison with epidemiological data from the West German Breast Center suggests that the patients in the PACT study are representative of a general postmenopausal early breast cancer population and that the findings may be applicable to 'real-world' Germany and beyond. Compliance data from PACT are eagerly anticipated. Copyright © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: Experiences of early life stress, increased psychological arousal and the body's physiologic stress response seem to play an important role in the pathogenesis and maintenance of borderline personality disorder (BPD). In the present study, we investigated alterations in grey matter of central stress-regulating structures in female patients with BPD. Methods: We examined T1 -weighted structural magnetic resonance imaging scans of unmedicated, right-handed female patients with BPD (according to DSM-IV criteria) and healthy controls matched for age, intelligence and education using fully automated DARTEL voxel-based morphometry. Our regions of interest analyses included the hippocampus, amygdala, anterior cingulate cortex (ACC) and hypothalamus. Results: We enrolled 30 patients and 33 controls in our study. The grey matter of patients with BPD was reduced in the hippocampus, but increased in the hypothalamus compared with healthy participants. Hypothalamic volume correlated positively with the history of traumatization in patients with BPD. No significant alterations were found in the amygdala and ACC. Limitations: This study is limited by the lack of measures of corticotropin-releasing hormone, adrenocorticotropic hormone and cortisol levels. Furthermore, moderate sample size and comorbid disorders need to be considered. Conclusion: Our findings provide new evidence for grey matter alterations in the hypothalamus and replicate previously reported decrements in hippocampal volume in patients with BPD. Understanding the role of the hypothalamus and other central stress-regulating structures could help us to further understand the neurobiological underpinnings of this complex disorder. [ABSTRACT FROM AUTHOR]

Background: Health Technology Assessments (HTAs) are used to inform decision-making and their usefulness depends on the quality and relevance of research and specific studies for health-policy decisions. Little is known about the country of origin of studies used for HTAs. Objective: To investigate which countries have made the largest contributions to inform health policy decisions through studies included in HTAs in Germany. Methods: The country of origin was extracted from all studies included in HTAs of the German Institute for Quality and Efficiency in Health Care, (IQWiG), published from 2/2006 to 9/2010. Studies were ranked according to the total number of studies per country, adjusted for population size, gross domestic product (GDP), and total health expenditure. Results: 1087 studies were included in 54 HTA reports. Studies were assigned to 45 countries. Most of the studies (27%) originated from the United States (USA), 18% were multinational, followed by 7% from the United Kingdom (UK) and 5% from Germany. Nordic countries led the ranking when adjusting for population size/million (ranks 1-3,6,9/45 countries), GDP/billion US$ (1,2,5,9,14/45), or health expenditure/billion US$ (1,3,5,12,13/45). The relative contribution of the UK was stable in the analyses when adjusted for population size (7/45), GDP (7/45), and health expenditure (9/45), whereas the USA (13, 18, and 30/45) and Germany (17, 19, and 21/45) dropped in the ranking. Conclusions: More than half of the studies relevant for evidence-informed decision-making in Germany originated from the USA, followed by multinational research and the UK. Only 5% of the studies originated from Germany. According to our findings, there appears to be some discrepancy between the use of globally generated evidence and the contribution to the knowledge pool by individual countries. [ABSTRACT FROM AUTHOR]

Background and objective We assessed the effect of regional deprivation on individual mortality by making use of a natural experiment: we followed up ethnic German resettlers from Former Soviet Union countries who were quasi-randomly distributed across the socio-economically heterogeneous counties of Germany's federal state North Rhine-Westphalia (NRW). Methods We used data from the retrospective cohort study 'AMOR' on the mortality of resettlers in NRW (n=34 393). Based on the postcode of the last known residence we linked study participants to the 54 counties of NRW, which were aggregated in six deprivation clusters. Mortality rates and standardised mortality ratios (SMRs) were calculated for each cluster. After a mean follow-up of 10 years, 2580 resettlers were deceased. Results For male and female cohort members, mortality rates and SMRs were highest in the cluster 'poverty poles' (SMR men: 1.21, 95% CI 1.04 to 1.41; SMR women: 1.17, 95% CI 0.99 to 1.37), whereas they were lowest in the cluster 'prospering regions and suburban counties' (SMR women: 0.86, 95% CI 0.70 to 1.05) as well as in the cluster 'heterogeneous counties' (SMR men: 0.73, 95% CI 0.61 to 0.88). Conclusions The population which was quasi-randomly distributed to counties of differing socioeconomic status experienced different levels of mortality. It was highest in regions with the highest level of regional deprivation. Previous studies describing this positive relationship between mortality and regional deprivation could not differentiate between compositional and contextual effects. Thus, our findings indicate that in terms of mortality, regional deprivation does matter. [ABSTRACT FROM AUTHOR]

Background: Yoga seems to be an effective means to cope with a variety of internal medicine conditions. While characteristics of yoga users have been investigated in the general population, little is known about predictors of yoga use and barriers to yoga use in internal medicine patients. The aim of this cross-sectional analysis was to identify sociodemographic, clinical, and psychological predictors of yoga use among internal medicine patients. Methods: A cross-sectional analysis was conducted among all patients being referred to a Department of Internal and Integrative Medicine during a 3-year period. It was assessed whether patients had ever used yoga for their primary medical complaint, the perceived benefit, and the perceived harm of yoga practice. Potential predictors of yoga use including sociodemographic characteristics, health behavior, internal medicine diagnosis, general health status, mental health, satisfaction with health, and health locus of control were assessed; and associations with yoga use were tested using multiple logistic regression analysis. Odds ratios (OR) with 95% confidence intervals (CI) were calculated for significant predictors. Results: Of 2486 participants, 303 (12.19%) reported having used yoga for their primary medical complaint. Of those, 184 (60.73%) reported benefits and 12 (3.96%) reported harms due to yoga practice. Compared to yoga nonusers, yoga users were more likely to be 50-64 years old (OR = 1.45; 95%CI = 1.05-2.01; P = 0.025); female (OR = 2.45; 95%CI = 1.45-4.02; P < 0.001); and college graduates (OR = 1.61; 95%CI = 1.14-2.27; P = 0.007); and less likely to currently smoke (OR = 0.61; 95%CI = 0.39-0.96; P = 0.031). Manifest anxiety (OR = 1.47; 95%CI = 1.06-2.04; P = 0.020); and high internal health locus of control (OR = 1.92; 95%CI = 1.38-2.67; P < 0.001) were positively associated with yoga use, while high external-fatalistic health locus of control (OR = 0.66; 95%CI = 0.47-0.92; P = 0.014) was negatively associated with yoga use. Conclusion: Yoga was used for their primary medical complaint by 12.19% of an internal integrative medicine patient population and was commonly perceived as beneficial. Yoga use was not associated with the patients' specific diagnosis but with sociodemographic factors, mental health, and health locus of control. To improve adherence to yoga practice, it should be considered that male, younger, and anxious patients and those with low internal health locus of control might be less intrinsically motivated to start yoga. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease is a leading cause of death. It is important to identify patient and treatment factors that are related to successful cardiovascular risk reduction in general practice. This study investigates which patient and treatment factors are related to changes in cardiovascular risk estimation, expressed as the Systematic Coronary Risk Evaluation (SCORE) 10 year risk of cardiovascular mortality. Methods: 179 general practice patients with mild-moderately elevated cardiovascular risk followed a one-year programme which included structured lifestyle and medication treatment by practice nurses, with or without additional self-monitoring. From the patient and treatment data collected as part of the "Self-monitoring and Prevention of RIsk factors by Nurse practitioners in the region of Groningen" randomized controlled trial (SPRING-RCT), the contribution of patient and treatment factors to the change in SCORE was analysed with univariate and multivariate analyses. Results: In multivariate analyses with multiple patient and treatment factors, only SCORE at baseline, and addition of or dose change in lipid lowering or antihypertensive medications over the course of the study were significantly related to change in SCORE. Conclusions: Our analyses support the targeting of treatment at individuals with a high SCORE at presentation. Lipid lowering medication was added or changed in only 12% of participants, but nevertheless was significantly related to ΔSCORE in this study population. Due to the effect of medication in this practice-based project, the possible additional effect of the home monitoring devices, especially for individuals with no indication for medication, may have been overshadowed. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity is defined as suffering from coexistent chronic conditions. Multimorbid patients demand highly complex patient-centered care which often includes polypharmacy, taking an average of six different drugs per day. Adverse drug reactions, adverse drug events and medication errors are all potential consequences of polypharmacy. Our study aims to detect the status quo of the health care situation in Saxony's general practices for multimorbid patients receiving multiple medications. We will identify the most common clinical profiles as well as documented adverse drug events and reactions that occur during the treatment of patients receiving multiple medications. We will focus on exploring the motives of general practitioners for the prescription of selected drugs in individual cases where there is evidence of potential drug-drug-interactions and potentially inappropriate medications in elderly patients. Furthermore, the study will explore general practitioners' opinions on delegation of skills to other health professions to support medical care and monitoring of patients receiving multiple medications. Methods/design: This is a retrospective cross sectional study using mixed methods. Socio-demographic data as well as diagnoses, medication regimens and clinically important events will be analyzed retrospectively using general practitioners documentation in patients' records. Based on these data, short vignettes will be generated and discussed by general practitioners in qualitative telephone interviews. Discussion: To be able to improve outpatient health care management for patients receiving multiple medications, the current status quo of care, risk factors for deficient treatment and characteristics of concerned patients must be investigated. Furthermore, it is necessary to understand the physicians' decision making process regarding treatment. [ABSTRACT FROM AUTHOR]

Background: Job satisfaction and organizational attributes in primary care teams are important issues as they affect clinical outcomes and the quality of health care provided. As practice assistants are an integral part of these teams it is important to gain insight into their views on job satisfaction and organizational attributes. The aim of this study was to evaluate the job satisfaction of practice assistants and the organizational attributes within their general practices in Germany and to explore the existence of possible associations. Methods: This observational study was based on a job satisfaction survey and measurement of organizational attributes in general practices in the German federal state of Baden-Wuerttemberg. Job satisfaction was measured with the 10-item 'Warr-Cook-Wall job satisfaction scale'. Organizational attributes were evaluated with the 21-items 'survey of organizational attributes for primary care' (SOAPC). Linear regression analyses were performed in which each of SOAPC scales and the overall score of SOAPC was treated as outcome variables. Results: 586 practice assistants out of 794 respondents (73.8%) from 234 general practices completed the questionnaire. Practice assistants were mostly satisfied with their colleagues and least of all satisfied with their income and recognition for their work. The regression analysis showed that 'freedom of working method' and 'recognition of work', the employment status of practice assistants and the mode of practice were almost always significantly associated with each subscale and overall score of SOAPC. Conclusions: Job satisfaction is highly associated with different aspects of organizational attributes for primary care ('communication', 'decision-making' and 'stress'). Consequently, improved job satisfaction could lead to a better-organized primary care team. This implication should be investigated directly in further intervention studies with a special focus on improving the recognition for work and income. [ABSTRACT FROM AUTHOR]

Objective To examine the psychometric properties of the German version of the 'observing patient involvement' scale (OPTION) by analysing video recordings of primary care consultations dealing with counselling in cardiovascular prevention. Design Cross-sectional assessment of physician-patient interaction by two rater pairs and two experts in shared decision making (SDM). Setting Primary care. Participants Fifteen general practitioners provided 40 videographed consultations. Measurements Video ratings using the OPTION instrument. Results Mean differences on item level between the four raters were quite large. Most items were skewed towards minimal levels of shared decision making. Measures of inter-rater association showed low to moderate associations on item level and high associations on total score level. Cronbach-α of the whole scale based on the data of all four raters is 0.90 and therefore on a high level. An oblique factor analysis revealed two factors, but both factors were highly correlated so we can confirm a one-dimensional structure of the instrument. ROC analyses between the rater total scores and dichotomized expert ratings (SDM yes/no) revealed a good discriminability of the OPTION total score. Physicians with more expertise in shared decision making received higher OPTION ratings. Conclusions The German version of the OPTION scale is reliable at total score level. Some items need further revision in the direction of more concrete, observable behaviour. We were only able to perform a quasi-validation of the scale. Validity issues need further research efforts. [ABSTRACT FROM AUTHOR]

Objectives. We examined the relationship between unemployment and mortality in Germany, a coordinated market economy, and the United States, a liberal market economy. Methods. We followed 2 working-age cohorts from the German Socioeconomic Panel and the US Panel Study of Income Dynamics from 1984 to 2005. We defined unemployment as unemployed at the time of survey. We used discrete-time survival analysis, adjusting for potential confounders. Results. There was an unemployment-mortality association among Americans (relative risk [RR] = 2.4; 95% confidence interval [CI] = 1.7, 3.4), but not among Germans (RR = 1.4; 95% CI = 1.0, 2.0). In education-stratified models, there was an association among minimum-skilled (RR = 2.6; 95% CI = 1.4, 4.7) and medium-skilled (RR = 2.4; 95% CI = 1.5, 3.8) Americans, but not among minimum- and medium-skilled Germans. There was no association among high-skilled Americans, but an association among high-skilled Germans (RR = 3.0; 95% CI = 1.3, 7.0), although this was limited to those educated in East Germany. Minimum- and medium-skilled unemployed Americans had the highest absolute risks of dying. Conclusions. The higher risk of dying for minimum- and medium-skilled unemployed Americans, not found among Germans, suggests that the unemployment- mortality relationship may be mediated by the institutional and economic environment. [ABSTRACT FROM AUTHOR]

Background: Skin stripping and impairment of the skin's function as a barrier are adverse effects that can be a consequence of the adhesives in wound dressings. Aim: To determine the best performing wound dressing in terms of skin protection without trauma. Method: Healthy volunteers had Mepitel® Film (Mölnlycke Health Care), Tegaderm® (3M®) and DuoDERM® Extra Thin (ConvaTec) dressings applied, removed and reapplied to the skin on their back over a period of 14 days. Skin barrier function was investigated using the amount of transepidermal water loss (TEWL) and then related to the amount of skin stripping, investigated by measuring stained skin removal. General signs of trauma, such as skin dryness and erythema, were investigated by subjective and objective parameters. Results: TEWL remained relatively unchanged for Mepitel Film and Tegaderm, however, the hydrocolloid dressing showed a significant increase in TEWL, indicating skin barrier function damage. The colour change of stained skin also indicated the removal of stratum corneum with the hydrocolloid dressing (DuoDERM) and, to a lesser extent, with the acrylic dressing (Tegaderm). Mepitel Film was associated with fewer reported trauma incidents, but no statistical difference was found for colour, skin dryness and erythema between the dressings. Conclusions: The best performing wound dressing in terms of skin protection without skin trauma was shown to be Mepitel Film. [ABSTRACT FROM AUTHOR]

There is an ongoing debate whether deaf individuals access phonology when reading, and if so, what impact the ability to access phonology might have on reading achievement. However, the debate so far has been theoretically unspecific on two accounts: (a) the phonological units deaf individuals may have of oral language have not been specified and (b) there seem to be no explicit cognitive models specifying how phonology and other factors operate in reading by deaf individuals. We propose that deaf individuals have representations of the sublexical structure of oral–aural language which are based on mouth shapes and that these sublexical units are activated during reading by deaf individuals. We specify the sublexical units of deaf German readers as 11 “visemes” and incorporate the viseme set into a working model of single-word reading by deaf adults based on the dual-route cascaded model of reading aloud by Coltheart, Rastle, Perry, Langdon, and Ziegler (2001. DRC: A dual route cascaded model of visual word recognition and reading aloud. Psychological Review, 108, 204–256. doi: 10.1037//0033-295x.108.1.204). We assessed the indirect route of this model by investigating the “pseudo-homoviseme” effect using a lexical decision task in deaf German reading adults. We found a main effect of pseudo-homovisemy, suggesting that at least some deaf individuals do automatically access sublexical structure during single-word reading. [ABSTRACT FROM PUBLISHER]

Background: Support for smoke-free policies increases over time and particularly after implementation of the policy. In this study we examined whether the comprehensiveness of such policies moderates the effect on support among smokers. Methods: We analysed two waves (pre- and post-smoke-free legislation) of the International Tobacco Control (ITC) surveys in France, Germany, and the Netherlands, and two pre-legislation waves of the ITC surveys in UK as control. Of 6,903 baseline smokers, 4,945 (71.6%) could be followed up and were included in the analyses. Generalised Estimating Equations (GEE) were used to compare changes in support from pre- to post-legislation to the secular trend in the control country. Multiple logistic regression models were employed to identify predictors of individual change in support. Findings: In France, the comprehensive smoking ban was associated with sharp increases in support for a total smoking ban in drinking establishments and restaurants that were above secular trends. In Germany and the Netherlands, where smoke-free policies and compliance are especially deficient in drinking establishments, only support for a total smoking ban in restaurants increased above the secular trend. Notable prospective predictors of becoming supportive of smoking bans in these countries were higher awareness of cigarette smoke being dangerous to others and weekly visiting of restaurants. Conclusions: Our findings suggest that smoke-free policies have the potential to improve support once the policy is in place. This effect seems to be most pronounced with comprehensive smoking bans, which thus might be the most valid option for policy-makers despite their potential for creating controversy and resistance in the beginning. [ABSTRACT FROM AUTHOR]

Background: As exposure to tobacco smoke pollution (TSP) has been identified as a cause of premature death and disease in non-smokers, and studies have demonstrated that smoking in cars produces high levels of TSP, this study will investigate smokers’ rules for smoking in their cars, and predictors of car smoking rules, including potentially modifiable correlates. Methods: Data were drawn from nationally representative samples of current smokers from the International Tobacco Control Policy Evaluation Project surveys in France (2007), Germany (2007), and the Netherlands (2008). Smokers in France and Germany were asked about smoking rules in their cars, and smokers in the Netherlands were asked about smoking rules in cars carrying children. Results: In France and Germany, 59% and 52% of smokers respectively, allowed smoking in their cars. In the Netherlands, 36% of smokers allowed smoking in cars carrying children. Predictors of allowing smoking in cars included: being a daily vs. non-daily smoker, being younger vs. older age, having no (young) children in the home, being a heavier smoker, and allowing smoking in the home. In the Netherlands, smokers who agreed that TSP is dangerous to non-smokers were less likely to allow smoking in cars carrying children. Conclusion: Overall, a sizeable proportion of smokers allowed smoking in their cars across the three countries. Media campaigns with information about the dangers of TSP may increase the adoption of smoke-free cars. These media campaigns could target smokers who are most likely to allow smoking in cars. [ABSTRACT FROM AUTHOR]

Background: Despite the ban on misleading descriptors such as light or mild cigarettes in Europe, there are still widespread misperceptions of the relative harmfulness of different brands of cigarettes among smokers. This study examined the extent to which smokers in three European countries believed that some cigarette brands are less harmful and why, using data from the International Tobacco Control (ITC) Europe surveys. Methods: Cross-sectional analyses were completed among nationally representative samples of 4,956 current smokers (aged ≥ 18) from Germany (n = 1,515), France (n = 1,735) and the United Kingdom (n = 1,706) conducted between September 2006 and November 2007. Logistic regression models examined whether outcomes, including beliefs that some cigarettes could be less harmful than others, varied by socio-demographic and country of residence. Findings: Around a quarter of smokers in the UK and France, and a third in Germany believed some cigarettes are less harmful than others. Overall, of smokers who falsely believed that some cigarettes are less harmful, 86.3% thought that tar/nicotine yields, 48.7% taste, and 40.4% terms on packs such as ‘smooth’ or ‘ultra’ indicated less harmful brands. About a fifth of smokers across all countries chose their brand based on health reasons, and a similar proportion gave tar yields as a reason for choosing brands. Conclusions: Our research suggests that the current European Tobacco Products Directive is inadequate in eliminating misperceptions about the relative risk of brand descriptors on cigarettes. There is therefore an urgent need to protect smokers in Europe from these misperceptions via stronger measures such as plain packaging regulations. [ABSTRACT FROM AUTHOR]

Background: Red yeast rice (i.e., rice fermented with Monascus spp.), as a food supplement, is claimed to be blood cholesterol-lowering. The red yeast rice constituent monacolin K, also known as lovastatin, is an inhibitor of the hydroxymethylglutaryl-CoA (HMG-CoA) reductase. This article aims to develop a sensitive nuclear magnetic resonance (NMR) method to determine the total statin content of red yeast rice products. Methods: The total statin content was determined by a 400 MHz 1H NMR spectroscopic method, based on the integration of the multiplet at &#948 5.37-5.32 ppm of a hydrogen at the hexahydronaphthalene moiety in comparison to an external calibration with lovastatin. The activity of HMG-CoA reductase was measured by a commercial spectrophotometric assay kit. Results: The NMR detection limit for total statins was 6 mg/L (equivalent to 0.3 mg/capsule, if two capsules are dissolved in 50 mL ethanol). The relative standard deviations were consistently lower than 11%. The total statin concentrations of five red yeast rice supplements were between 1.5 and 25.2 mg per specified daily dose. A dosedependent inhibition of the HMG-CoA reductase enzyme activity by the red yeast rice products was demonstrated. Conclusion: A simple and direct NMR assay was developed to determine the total statin content in red yeast rice. The assay can be applied for the determination of statin content for the regulatory control of red yeast rice products. [ABSTRACT FROM AUTHOR]

Objective. Recent data suggest that fetal antigen (FA1) is linked to disorders of body weight. Thus, wemeasured FA1 serum levels in two extreme nutritional states of morbid obesity (MO) and anorexia nervosa (AN) and monitored its response to weight changes. Design. FA1 and insulin serum concentrations were assessed in a cross-sectional study design at defined time points after gastric restrictive surgery for 25 MO patients and 15 women with AN. Results. Absolute FA1 serum levels were within the assay normal range and were not different between the groups at baseline. However, the ratio of FA1/BMI was significantly higher in AN. FA1 was inversely correlated with BMI before and after weight change in AN, but not in MO patients. In addition, MO patients displayed a significant concomitant decrease of FA1 and insulin with the first 25% of EWL, while in AN patients a significant increase of FA1 was observed in association with weight gain. Conclusion. FA1 is a sensitive indicator of metabolic adaptation during weight change. While FA1 serum levels in humans generally do not correlate with BMI, our results suggest that changes in FA1 serum levels reflect changes in adipose tissue turnover. [ABSTRACT FROM AUTHOR]

Background: Since 2004, a national Disease Management Program (DMP) has been implemented in Germany, which includes educational measures aimed at patients with type-2 diabetes (T2D). However, about 15-20% of T2D patients remain in poor metabolic control. Qualitative research shows that one reason for this might be an increasing frustration of general practitioners (GPs) with the management of their poorly regulated T2D patients over time. We aim at approaching this problem by improving the GP-patient-communication and fostering shared decision-making. Methods/Design: An educative intervention will be tested within a multi-centred cluster-randomized controlled trial (RCT) in Germany. We include 20 GPs in three regions. Each of the 60 GPs will recruit about 13 patients meeting the inclusion criteria (total of 780 patients). GPs allocated to the intervention group will receive a peer-visit from a specifically trained GP-colleague who will motivate them to apply patient-centred communication techniques including patient-centred decision aids. GPs allocated to the control group will not take part in any intervention program, but will provide care as usual to their patients. The primary inclusion criterion for patients at the time of the recruitment is an HbA1c-level of over 8.0. Primary outcome is the change of HbA1c at 6, 12, 18, and 24 months compared to HbA1c at baseline. Secondary outcomes include patient's participation in the process of shared decision-making and quality of life. Discussion: If this intervention proves to be effective it may be integrated into the existing Disease Management Program for T2D in Germany. [ABSTRACT FROM AUTHOR]

Background: With an average prescription rate of 50%, in German primary care antibiotics are still too frequently prescribed for respiratory tract infections. The over-prescription of antibiotics is often explained by perceived patient pressure and fears of a complicated disease progression. The CHANGE-2 trial will test the effectiveness of two interventions to reduce the rate of inappropriate antibiotic prescriptions for adults and children suffering from respiratory tract infections in German primary care. Methods/Design: The study is a three-arm cluster-randomized controlled trial that measures antibiotic prescription rates over three successive winter periods and reverts to administrative data of the German statutory health insurance company AOK. More than 30,000 patients in two regions of Germany, who visit their general practitioner or pediatrician for respiratory tract infections will be included. Interventions are: A) communication training for general practitioners and pediatricians and B) intervention A plus point-of-care testing. Both interventions are tested against usual care. Outcome measure is the physicians' antibiotic prescription rate for respiratory tract infections derived from data of the health insurance company AOK. Secondary outcomes include reconsultation rate, complications, and hospital admissions. Discussion: Major aim of the study is to improve the process of decision-making and to ensure that patients who are likely to benefit from antibiotics are treated accordingly. Our approach is simple to implement and might be used rapidly among general practitioners and pediatricians. We expect the results of this trial to have major impact on antibiotic prescription strategies and practices in Germany, both among general practitioners and pediatricians. Trial registration: The study is registered at the Current Controlled Trials Ltd (ISRCTN01559032) [ABSTRACT FROM AUTHOR]

Purpose. To investigate the age-specific pattern of administration of chemotherapy and its association with long-term survival and quality of life (QoL) in stage II and III colorectal cancer patients. Methods. Chemotherapy allocation according to disease and patient characteristics was investigated in a population-based cohort of 562 stage II and III colorectal cancer patients. Five years after diagnosis, survival was determined and QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items and a tumor specific module. The association among chemotherapy, survival, and QoL was examined while controlling for potential confounders. Results. Chemotherapy was administered in 71% of patients aged <60 years and in only 20% of patients aged ≥80 years. A significant association between chemotherapy and longer survival time was found for stage III cancer only. Chemotherapy was associated with higher symptom levels for trouble with taste, anxiety, and hair loss. In age-specific analyses, younger survivors (<70 years at time of follow-up) with a history of chemotherapy reported significantly lower physical, role, and cognitive functioning and higher pain, appetite loss, hair loss, and trouble with taste symptom levels. In contrast, for older survivors (≥70 years), only two (hair loss and dry mouth) out of 38 QoL scores were significantly associated with chemotherapy. Discussion. Chemotherapy is associated with lower long-term QoL, especially in younger survivors. In cases of uncertain survival benefits of chemotherapy, consideration of its long-term effects on QoL should be incorporated into final decisions on treatment. [ABSTRACT FROM AUTHOR]

Background: Cost-effectiveness analyses have focused on aromatase inhibitors (AIs), but the results are inconsistent and disease-free survival has often been extrapolated to overall survival. The present study calculates the cost-effectiveness of 5 years of letrozole versus tamoxifen versus anastrozole in the context of the German health care system, using survival data from the Breast International Group (BIG) 1-98 study and the Arimidex, Tamoxifen, Alone or in Combination (ATAC) study and generic prices. Materials and Methods: A hybrid model was developed that incorporates recurrence rates, overall survival, treatment costs and treatment-associated adverse events and the resulting costs. The basic assumption was that generic anastrozole would lead to a price reduction to 75% of the original price. Further analyses were carried out with 50% and 25% of the original prices for anastrozole and letrozole. Results: The cost-benefit model showed a gain of 0.3124 or 0.0659 quality-adjusted life years (QALYs) for letrozole or anastrozole. Incremental costs of € 29,375.15/QALY for letrozole (100% of original price) were calculated and € 94,648.03/QALY for anastrozole (75% of original price). Marked increases in cost-effectiveness are observed with further decreases in price (anastrozole: 50% price € 54,715.17/QALY, 25% price € 14,779.57/QALY; letrozole 75% price € 20,988.59/QALY, 50% price € 12,602.03/QALY, 25% price € 4,215.46/QALY). Conclusion: The present model including the inverse probability of censoring weighted analysis (IPCW) for letrozole and generic prices for both AIs shows that letrozole is cost effective. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

The UK has long experienced a shortage of social workers and has recruited internationally to meet demand. There have been few specific data quantifying the scale of social work mobility to the UK through which such experiences can be set in context. The analysis reported in this article uses data from October 2008, relating to registered social workers working in England. As part of a wider study of migrant social care workers in England, the article reports analysis of data records of over 7,000 non-UK social workers registered to work in England and compares their characteristics to UK-qualified social workers. These analyses are supplemented by analysis of more recent application and registration data from the General Social Care Council pertaining to social workers qualified within and outside the European Union during 2008 and 2009. The findings highlight several important observations in terms of non-UK-qualified social workers' profile as well as some possible trends in migration and variations in rates of qualification verification. Over half of all international social workers in England were trained in four countries: Australia, South Africa, India and the USA. Findings are contextualised with qualitative data obtained from the wider study and policy debates. [ABSTRACT FROM PUBLISHER]

Background While coverage of a celebrity suicide in the mass media may trigger copycat suicides, evidence for the effect of media reports of non-prominent suicides is moderate. Diversification of current media may raise further doubts as to whether their influence on suicidal acts is still present. We examined whether widespread media coverage of a railway accident, in which several people were killed while investigating a presumed railway suicide, subsequently increased the number of railway suicides. Methods The daily incidence of railway suicides was derived from the national accident registry on the German railway net. We estimated incidence ratios by Poisson regression, adjusting for relevant confounders (eg, outdoor temperature, unemployment rate), for the 2 months following the accident (predefined index period) and predefined control periods (preceding 2 years of the same period and 1 month before/after the index period). Results The mean number of railway suicides per day in the index period increased significantly to 2.66 (95% CI 2.19 to 3.13) compared to 1.94 (95% CI 1.78 to 2.10) during both control periods. Fully adjusted Poisson regression showed a 44% daily increase in railway suicides in the index period compared to the control periods (incidence ratio 1.44, 95% CI 1.02 to 2.03). A maximum of eight suicides per day was reached about 1 week after the accident. Conclusions Non-fictional media coverage of a fatal accident appears to affect subsequent railway suicide numbers. Supposedly, media reports drew attention to railways as a means of suicide. [ABSTRACT FROM AUTHOR]

Background: Internationally, in many healthcare systems financial pressure has led to the implementation of co-payments, private medical (extra) services and rationing. In Germany, members of statutory health insurances (SHIs) increasingly report the denial of medical services and the offer/demand of privately financed supplementary health services individual health services, (IHSs) in medical practices. The public discussion on both denial and IHSs is chequered, mainly critical, partly polemic. The present study aims to operationalize IHSs and denial and investigates their occurrence, socio-demographic determinants within two regional populations. Methods: Two postal surveys were conducted in 4898 German inhabitants of Lübeck (Northern Germany) and Freiburg (Southern Germany), aged 20–79 years. The survey focused on experiences with IHSs and denial of health services in medical practices among members of SHIs. Results: In all members of SHIs that had consulted a physician during the past 12 months (n =1899), the one-year-prevalence of IHSs and denial of medical services were 41.7 and 20.5%. About 40% were offered a denied medical service as an IHS later. Conclusion: The study presents population-based, quantitative data on IHSs and denial of medical services in German practices. The results partly confirm former findings on the occurrence of IHSs. Contrary to other studies, socio-demographics seemed to play a minor role in the offer/demand of IHSs. [ABSTRACT FROM PUBLISHER]

Background: Transcranial sonography (TCS) has become a new diagnostic tool in the evaluation of extrapyramidal disorders. Studies of TCS report alterations of the mesencephalic raphe in patients with depression. The aim of this study was to evaluate TCS findings in patients with Huntington disease in correlation with their neurologic and psychiatric status. Methods: We recruited patients with genetically confirmed Huntington disease. The neurological and psychiatric status of participants was assessed by independent physicians. Echogenicities were investigated according to examination protocol for extrapyramidal disorders using a Siemens Sonoline Elegra system. The sonography examiner was blinded for clinical data. Results: We included 39 patients in our study; 21 patients (53.8%) showed symptoms of depression at the time of evaluation and, of those, 15 (71.4%) had hypoechogenic raphe structures. Thirty patients (76.9%) had a history of depressive episodes, 19 (63.3%) of them with hypoechogenic raphe structures. All 9 patients without a history of depressive episodes showed normal echogenicity of raphe structures (sensitivity 63.3%, specificity 100%). Twelve (70.6%) of the 17 patients with Huntington disease who showed psychiatric disturbances prior to the occurrence of motor symptoms exhibited pathological raphe echogenicity (sensitivity 70.6%, specificity 68.2%). Limitations: Most of the patients were taking antichoreatic medication, which particularly influences neurologic status. Thus, a meaningful interpretation of the correlation between TCS findings and neurologic features was limited. Conclusion: As a novel finding, a relation between mesencephalic raphe echogenicity and depressive state could be identified in patients with Huntington disease. An alteration of the serotonergic brain stem raphe might be involved in the pathogenesis of depression in these patients. [ABSTRACT FROM AUTHOR]

Shared Decision Making (SDM) is widely accepted as the preferred method for reaching treatment decisions in the oncology setting including those about clinical trial participation: however, there is some disagreement between researchers over the components of SDM. Specific standardized coding systems are needed to help overcome this difficulty. The first objective was to describe the development of an oncology specific SDM coding system, the DAS-O. The second objective was to provide reliability and validity data supporting the DAS-O. Consultation data were available from tertiary cancer center out patient oncology clinics in: Australia, New Zealand (ANZ), Switzerland, Germany and Austria (SGA). Patients were women with a confirmed diagnosis of early stage breast cancer. Reliability data were from 18 randomly selected coded transcripts drawn from ANZ and SGA. Concurrent validity data are from 55 (ANZ) consultations. Inter and Intra rater reliability data was evaluated using Kappa correlation statistics and correlation coefficients. Correlation coefficients were used to assess concurrent validity between the DAS-O and two other SDM coding systems, OPTION and DSAT. Inter and Intra rater reliability for the system were high with average Kappas of 0.58 and 0.65 respectively. Correlation coefficients between DAS-O and OPTION was 0.73 and >0.5 for DSAT. We have developed a reliable and valid coding system for identifying and rating the quality of SDM in breast cancer consultations. [ABSTRACT FROM AUTHOR]

Objectives. To evaluate and compare the efficacy and acceptability of the antidepressants amitriptyline (AMT), duloxetine (DLX) and milnacipran (MLN) for FM syndrome (FMS).Methods. Cochrane Library, MEDLINE, SCOPUS, www.clinicalstudyresults.org and www.clinicalTrials.gov were searched for randomized pharmacological placebo-controlled trials until 30 May 2010. Outcomes of interest were symptom reduction [pain, fatigue, sleep disturbance and reduced health-related quality of life (HRQOL)] and acceptability (total drop-out rates). We performed a meta-analysis of each drug vs placebo using a random-effects model and adjusted indirect analyses of the three drugs. Methodological quality was assessed by the Cochrane risk of bias tool.Results. Ten AMT studies (612 patients), four DLX studies (1411 patients) and five MLN studies (4129 patients) met the inclusion criteria. The reported methodological quality of most AMT trials was poor, that of DLX and MLN were high. The three drugs were superior to placebo except DLX for fatigue, MLN for sleep disturbance and AMT for HRQOL. The significant effects of AMT and DLX were small and those of MLN not substantial. In adjusted indirect comparisons, AMT was superior to DLX and MLN in reduction of pain, sleep disturbances, fatigue and limitations of HRQOL. DLX was superior to MLN in reducing pain, sleep disturbances and limitations of HRQOL. MLN was superior to DLX in reducing fatigue. There were no significant differences in acceptability of the three drugs.Conclusions. AMT cannot be regarded as the gold standard of FMS therapy with antidepressants because of the methodological limitations of its trials.Key words: Fibromyalgia syndrome, Amitriptyline, Duloxetine, Milnacipran, Efficacy, Acceptability. [ABSTRACT FROM PUBLISHER]

This explorative survey investigated clients' evaluation of therapy elements and other supportive factors within a randomized controlled trial. The treatment of patients with alcohol dependence consisted of pharmacotherapy (acamprosate/naltrexone/placebo) and biweekly medical management (MM). Forty-nine study participants were surveyed with a questionnaire to measure both the patients' satisfaction with the therapy and the subjective assessment of treatment elements and supportive factors. Study participants were highly satisfied with the treatment. The supportive factors previously identified by Orford et al1 were confirmed. 'Pharmacotherapy' was rated significantly less effective than 'MM' and 'global study attendance' (P < 0.001). The significant differences in the evaluation of treatment elements point to a preference for regular low-key contacts rather than for medication. Such contacts based on MM could be a useful intervention in clinical care, and its effectivity should be examined more closely in further research. [ABSTRACT FROM AUTHOR]

Background: Patents are one of the most important forms of intellectual property. They grant a time-limited exclusivity on the use of an invention allowing the recuperation of research costs. The use of patents is fiercely debated for medical innovation and especially controversial for publicly funded research, where the patent holder is an institution accountable to public interest. Despite this controversy, for the situation in Germany almost no empirical information exists. The purpose of this study is to examine the amount, types and trends of patent applications for health products submitted by German public research organisations. Methods/Principal Findings: We conducted a systematic search for patent documents using the publicly accessible database search interface of the German Patent and Trademark Office. We defined keywords and search criteria and developed search patterns for the database request. We retrieved documents with application date between 1988 and 2006 and processed the collected data stepwise to compile the most relevant documents in patent families for further analysis. We developed a rationale and present individual steps of a systematic method to request and process patent data from a publicly accessible database. We retrieved and processed 10194 patent documents. Out of these, we identified 1772 relevant patent families, applied for by 193 different universities and non-university public research organisations. 827 (47%) of these patent families contained granted patents. The number of patent applications submitted by universities and university-affiliated institutions more than tripled since the introduction of legal reforms in 2002, constituting almost half of all patent applications and accounting for most of the post-reform increase. Patenting of most non-university public research organisations remained stable. Conclusions: We search, process and analyse patent applications from publicly accessible databases. Internationally mounting evidence questions the viability of policies to increase commercial exploitation of publicly funded research results. To evaluate the outcome of research policies a transparent evidence base for public debate is needed in Germany. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder is associated with both structural and functional alterations in the emotion regulation network of the central nervous system. The relation between structural and functional changes is largely unknown. Therefore, we sought to determine the relation between structural differences and functional alterations during the recognition of emotional facial expressions. Methods: We examined 13 medication-free patients with major depression and 15 healthy controls by use of structural T1-weighted high-resolution magnetic resonance imaging (MRI) and functional MRI during 1 session. We set the statistical threshold for the analysis of imaging data to p < 0.001 (uncorrected). Results: As shown by voxel-based morphometry, depressed patients had reductions in orbitofrontal cortex volume and increases in cerebellar volume. Additionally, depressed patients showed increased activity during emotion recognition in the middle frontal cortex, caudate nucleus, precuneus and lingual gyrus. Within this cerebral network, the orbitofrontal volumes were negatively correlated in depressed patients but not in healthy controls with changes in blood oxygen level--dependent signal in the middle frontal gyrus, caudate nucleus, precuneus and supplementary motor area. Limitations: Our results are limited by the relatively small sample size. Conclusions: This combined functional and structural MRI study provides evidence that the orbitofrontal cortex is a key area in major depression and that structural changes result in functional alterations within the emotional circuit. Whether these alterations in the orbitofrontal cortex are also related to persistent emotional dysfunction in remitted mental states and, therefore, are related to the risk of depression needs further exploration. [ABSTRACT FROM AUTHOR]

Loneliness concerns the subjective evaluation of the situation individuals are involved in, characterized either by a number of relationships with friends and colleagues which is smaller than is considered desirable (social loneliness), as well as situations where the intimacy in confidant relationships one wishes for has not been realized (emotional loneliness). To identify people who are lonely direct questions are not sufficient; loneliness scales are preferred. In this article, the quality of the three-item scale for emotional loneliness and the three-item scale for social loneliness has been investigated for use in the following countries participating in the United Nations “Generations and Gender Surveys”: France, Germany, the Netherlands, Russia, Bulgaria, Georgia, and Japan. Sample sizes for the 7 countries varied between 8,158 and 12,828. Translations of the De Jong Gierveld loneliness scale have been tested using reliability and validity tests including a confirmatory factor analysis to test the two-dimensional structure of loneliness. Test outcomes indicated for each of the countries under investigation reliable and valid scales for emotional and social loneliness, respectively. [ABSTRACT FROM AUTHOR]

Caregiver counselling has proved to be effective in reducing the burden of family caregivers of dementia patients. Nevertheless, little is known about the influencing factors for utilization and quality expectations of family caregivers. In this article, we address the following questions on the theoretical base of the Andersen/Newman model: Which variables of the care situation, the caregivers and their attitudes act as predictors for the utilization of caregiver counselling? What are the views of caregivers about the quality of caregiver counselling? The cross-sectional study was carried out as an anonymous written survey of family caregivers of dementia patients in four regions, both urban and rural, of Germany. Quantitative and qualitative data from 404 family caregivers were analysed using binary logistic regression analysis and qualitative content analysis, respectively. The only significant predictor for utilization is the assessment of how helpful caregiver counselling is for the individual care situation. In the sensitivity analysis ‘accessibility of caregiver counselling’ was additionally predictive for usage. Family caregivers most frequently expressed a wish for advice about further ‘support offers’ by qualified counsellors. In order to increase the rate of utilization, family caregivers must be convinced of the relevant advantages of using caregiver counselling. Counselling services should provide information about further support offers and give practical help in filling out application forms. [ABSTRACT FROM AUTHOR]

The article discusses the idea of the modern university in light of the thought of philosopher Wilhelm von Humboldt, noting his influence on German universities. The author addresses the subsequent fate of the idea of the university due to mass education, government involvement in funding research, and the continuing importance of student participation in research. Other topics include the role of university presidents, academic-industrial collaboration, and the efforts of the United States government to promote diversity within student bodies.

Background: Evaluating the completeness of tuberculosis (TB) notification data is important for monitoring of TB surveillance systems. We conducted an inventory study to calculate TB underreporting in Germany in 2013-2017.Methods: Acquisition of two pseudonymized case-based data sources (national TB notification data and antibiotic resistance surveillance data) was followed by two-source Capture-recapture (CRC) analysis, as case-based data from a third source was unavailable. Aggregated data on consumption of a key anti-TB drug (pyrazinamide [PZA]) was compared to an estimated need for PZA based on TB notification data to obtain an independent underreporting estimation. Additionally, notified TB incidence was compared to TB rate in an aggregated health insurance fund dataset.Results: CRC and PZA-based approaches indicated that between 93 and 97% (CRC) and between 91 and 95% (PZA) of estimated cases were captured in the national TB notification data in the years 2013-2017. Insurance fund dataset did not indicate TB underreporting on the national level in 2017.Conclusions: Our results suggest that more than 90% of estimated TB cases are captured within the German TB surveillance system, and accordingly the TB notification rate is likely a good proxy of the diagnosed TB incidence rate. An increase in underreporting and discrepancies however should be further investigated. [ABSTRACT FROM AUTHOR]

Background: Healthy life years have superseded life expectancy (LE) as the most important indicator for population health. The most common approach to separate the total number of life years into those spent in good and poor health is the Sullivan method which incorporates the health dimension to the classic period life table, thus transforming the LE indicator into the health expectancy (HE) indicator. However, life years derived from a period life table and health prevalence derived from survey data are based on different conceptual frameworks. Method: We modify the Sullivan method by combining the health prevalence data with the conceptually better fitting cross-sectional average length of life (CAL). We refer to this alternative HE indicator as the "cross-sectional average length of healthy life" (HCAL). We compare results from this alternative indicator with the conventional Sullivan approach for nine European countries. The analyses are based on EU-SILC data in three empirical applications, including the absolute and relative level of healthy life years, changes between 2008 and 2014, and the extent of the gender gap. Results: HCAL and conventional HE differ in each of these empirical applications. In general, HCAL provides larger gains in healthy life years in recent years, but at the same time greater declines in the proportion of healthy life years. Regarding the gender gap, HCAL provides a more favourable picture for women compared to conventional HE. Nonetheless, the extent of these differences between the indicators is only of minor extent. Conclusions: Albeit the differences between HE and HCAL are small, we found some empirical examples in which the two indicators led to different conclusions. It is important to note, however, that the measurement of health and the data quality are much more important for the healthy life years indicator than the choice of the variant of the Sullivan method. Nonetheless, we suggest to use HCAL in addition to HE whenever possible because it widens the spectrum of empirical analyses and serves for verification of results based on the highly sensitive HE indicator. [ABSTRACT FROM AUTHOR]

Background: A sufficient amount of regular moderate physical activity (PA), at least 2.5 h of moderate to vigorous PA per week as recommended by the WHO, is one of the most important lifestyle factors for maintaining good health in old age. However, less than one in four older adults (65 years or older) in Germany meets this recommendation for PA. Although previous research has found several factors related to participation in PA programmes, little is known about how these factors simultaneously affect participation decisions of older adults and how PA programmes can accommodate these dynamics. Taking an everyday life perspective, this study aimed to identify multidimensional types of PA behaviour among older adults.Methods: In this qualitative study, 25 episodic interviews were conducted with participants and non-participants (ratio 1:3) of a structured PA intervention for older adults (65 years or older). Direct and indirect recruitment methods (e.g. pick up, gatekeeper) were used in different municipalities in Northwest Germany. The interviews were analysed according to the Grounded Theory methodology and a typology of PA participation behaviour was derived from the responses of the interviewees.Results: Four types of PA participation behaviour were identified based on different activity goals and time management preferences: 'Health designer', 'Flexible function-oriented type', 'Comparison and competition type' and 'Fun and wellness-oriented type'. The results indicate that the structured PA intervention was better able to reach the health designer and the competitive type but was less successful in accommodating the function- or wellness-oriented type.Conclusions: In order to improve older adults' participation in PA, preventive offers should take various activity goals and the desire for flexible time management in everyday life into account. The typology of PA participation behaviour contributes to a better understanding of the target group and can thus help to improve the development, communication and implementation of tailored PA interventions. [ABSTRACT FROM AUTHOR]

Background: The aim of this pilot study was to assess the feasibility of a large-scale epidemiologic investigation elucidating the quantitative association between occupational exposure to asbestos and ovarian cancer in former German asbestos workers.Methods: Between December 2017 and May 2018, a random sample of one thousand insured woman registered at the health service of a German trade association as formerly occupationally exposed to asbestos were invited to participate in a pilot study. Participation included a phone interview using a standardised questionnaire. The feasibility of the project was evaluated using a priori defined criteria. They included response, number of cases, eligibility of the questionnaire data for exact estimation of asbestos fibre-years, and availability of relevant medical documentation (imaging procedures, medical reports, and histologic materials).Results: The response (17%) was clearly below the intended number of 60%. With six tumour suspects, of which two could be confirmed by medical documents, the number of cases was within the expected range of two to eleven cases. Exact asbestos fibre-year estimations could be performed for 29% of all interviewees, but only for one suspected case. Medical documentation could be collected for only few participants, while no histology reports could be obtained for all cases. Thus, only the feasibility criterion of the expected number of cases was fulfilled.Conclusion: The results of the pilot study indicate that the planned project is feasible only to a very limited extent. For further planning of the study, measures to improve recruitment of participants are necessary. [ABSTRACT FROM AUTHOR]

Background: Regional prevalence estimation requires epidemiologic data with substantial local detail. National health surveys may lack in sufficient local observations due to limited resources. Therefore, corresponding prevalence estimates may not capture regional morbidity patterns with the necessary accuracy. Health insurance records represent alternative data sources for this purpose. Fund-specific member populations have more local observations than surveys, which benefits regional prevalence estimation. However, due to national insurance market regulations, insurance membership can be informative for morbidity. Regional fund-specific prevalence proportions are selective in the sense that the morbidity structure of a fund's member population cannot be extrapolated to the national population. This implies a selection bias that marks a major obstacle for statistical inference. We provide a methodology to adjust fund-specific selectivity and perform regional prevalence estimation from health insurance records. The methodology is applied to estimate regional cohort-referenced diabetes mellitus type 2 prevalence in Germany. Methods: Records of the German Public Health Insurance Company from 2014 and Diagnosis-Related Group Statistics data are combined within a benchmarked multi-level model. The fund-specific selectivity is adjusted in a two-step procedure. Firstly, the conditional expectation of the insurance company's regional prevalence given related inpatient diagnosis frequencies of its members is quantified. Secondly, the regional prevalence is estimated by extrapolating the conditional expectation using corresponding inpatient diagnosis frequencies of the Diagnosis-Related Group Statistics as benchmarks. Model assumptions are validated via Monte Carlo simulation. Variable selection is performed via multivariate methods. The optimal model fit is determined by analysis of variance. 95% confidence intervals for the estimates are constructed via semiparametric bootstrapping. Results: The national diabetes mellitus type 2 prevalence is estimated at 8.70% with a 95% confidence interval of [8.48%, 9.35%]. This indicates an adjustment of the original fund-specific prevalence from − 32.79 to − 25.93%. The estimated disease distribution shows significant morbidity differences between regions, especially between eastern and western Germany. However, the cohort-referenced estimates suggest that these differences can be partially explained by regional demography. Conclusions: The proposed methodology allows regional prevalence estimation in remarkable detail despite fund-specific selectivity. This enhances and encourages the use of health insurance records for future epidemiologic studies. [ABSTRACT FROM AUTHOR]

Background: Podocyte infolding glomerulopathy (PIG) is a rare histopathologic finding with global infolding of the podocytes into the glomerular basement membrane (GBM), accompanied by microstructures underneath. Described in 2002 for the first time, PIG was proposed as a new pathological entity in 2008 based on the largest case series so far. Yet all of the described cases derive from Asian countries. We report a case from Germany fulfilling the diagnostic criteria of PIG. Considering the scarcity of data on this entity especially in Western countries, collecting cases like ours and multicentric meta-analyses will be crucial to obtain a better understanding of PIG, its causes, clinical course and potential treatment options.Case Presentation: A 56-year-old Caucasian woman with a history of rheumatoid arthritis (RA), no other comorbidities and no known renal disease was admitted to the hospital with acute kidney injury (AKI) and nephrotic syndrome. Physical examination was unremarkable except for anasarca. Renal ultrasound revealed no abnormalities. Laboratory and urine analyses were consistent with the nephrotic syndrome and renal failure. Serological studies regarding ANA, ANCA, anti-PLA2R autoantibodies, complement, virus infections, immunofixation and quantitative light chain analysis were unremarkable. A renal biopsy was performed. Light microscopic examination showed flattened tubular epithelium consistent with acute tubular damage, no infiltrates and unremarkable glomeruli except diffuse and global holes in the GBM (Fig. 1a) and negative staining for immunoglobulin heavy-chains, light-chains and complement split products. Electron microscopy revealed a rare correlate for these holes: global peculiar infolding of podocyte cytoplasm into the GBM. Most of these infoldings were accompanied by condensation of the GBM underneath. No such condensation or electron dense deposits were found without these infoldings or outside the GBM.Conclusion: Here we report the first case of PIG outside of Asia. Since there are only few reports about this specific finding, we feel there is a need to share information in an attempt to accumulate knowledge about this possible new entity and potential treatment options. [ABSTRACT FROM AUTHOR]