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Background: Youths with extreme obesity (Body mass index (BMI)>40) are at increased risk for physical and mental health impairments but this patient group has received little attention in research. This study aimed to analyze the pain experience and mental health impairments of youths with extreme obesity compared to those with mild and moderate obesity (BMI=30–39.9) by considering gender differences. Methods: Cross-sectional data of 431 youths (M=16.6; SD=2.3; 53.1% female) were analyzed. Of these, 159 (36.8%) youths were characterized by extreme obesity. Self-reported sociodemographic data, pain-related variables, depression, and health-related quality of life (HRQoL) were assessed with standardized questionnaires. Data were analyzed with univariate tests and logistic regression models. Results: Youths with extreme obesity reported more pain in the last 4 weeks (p=.018), increased pain-related impairments in daily life (p=.009), more pain-related days of absence (p=.030), higher depression scores (p = .030), and reduced HRQoL (p=.005) compared to youths with mild and moderate obesity. In regression models, extreme obesity and pain in the last 4 weeks were associated when additionally including sex and age in the model (odds ratio 1.88; 95 % confidence interval 1.16 - 30.40, p=.010). In the subgroup of extreme obesity (n=159), women (n=83) reported more pain in the last 4 weeks (p=.001), higher depression scores (p

Abstract Background Overweight and obesity are severe public health problems worldwide. Obesity can lead to chronic diseases such as type 2 diabetes mellitus. Environmental factors may affect lifestyle aspects and are therefore expected to influence people’s weight status. To assess environmental risks, several methods have been tested using geographic information systems. Freely available data from online geocoding services such as OpenStreetMap (OSM) can be used to determine the spatial distribution of these obesogenic factors. The aim of our study was to develop and test a spatial obesity risk score (SORS) based on data from OSM and using kernel density estimation (KDE). Methods Obesity-related factors were downloaded from OSM for two municipalities in Bavaria, Germany. We visualized obesogenic and protective risk factors on maps and tested the spatial heterogeneity via Ripley’s K function. Subsequently, we developed the SORS based on positive and negative KDE surfaces. Risk score values were estimated at 50 random spatial data points. We examined the bandwidth, edge correction, weighting, interpolation method, and numbers of grid points. To account for uncertainty, a spatial bootstrap (1000 samples) was integrated, which was used to evaluate the parameter selection via the ANOVA F statistic. Results We found significantly clustered patterns of the obesogenic and protective environmental factors according to Ripley’s K function. Separate density maps enabled ex ante visualization of the positive and negative density layers. Furthermore, visual inspection of the final risk score values made it possible to identify overall high- and low-risk areas within our two study areas. Parameter choice for the bandwidth and the edge correction had the highest impact on the SORS results. Discussion The SORS made it possible to visualize risk patterns across our study areas. Our score and parameter testing approach has been proven to be geographically scalable and can be applied to other geographic areas and in other contexts. Parameter choice played a major role in the score results and therefore needs careful consideration in future applications.

Abstract Background The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. Methods Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. Results There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as “good”, while for a PCS score above 40 there is a reverse effect. Conclusions The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

ObjectiveThe presence and intensity of symptoms vary in patients with unilateral vestibular hypofunction. We aimed to determine which saccadic and vestibulo-ocular reflex parameters best predict the presence of symptoms in unilateral vestibular hypofunction in order to better understand vestibular compensation and its implications for rehabilitation therapy.MethodsVideo head impulse test data were analyzed from a subpopulation of 23 symptomatic and 10 currently symptom-free participants with unilateral vestibular hypofunction, embedded in the KORA (Cooperative Health Research in the Region of Augsburg) FF4 study, the second follow-up of the KORA S4 population-based health survey (2,279 participants).ResultsA higher number of catch-up saccades, a higher percentage of covert saccades, and a larger retinal error at 200 ms after the onset of the head impulse were associated with relevant symptoms in participants with unilateral vestibular hypofunction (p = 0.028, p = 0.046, and p = 0.038, respectively). After stepwise selection, the number of catch-up saccades and retinal error at 200 ms remained in the final logistic regression model, which was significantly better than a null model (p = 0.014). Age, gender, saccade amplitude, saccade latency, and VOR gain were not predictive of the presence of symptoms.ConclusionThe accuracy of saccadic compensation seems to be crucial for the presence of symptoms in unilateral vestibular hypofunction, highlighting the role of specific gaze stabilization exercises in rehabilitation. Early saccades, mainly triggered by the vestibular system, do not seem to compensate accurately enough, resulting in a relevant retinal error and the need for more as well as more accurate catch-up saccades, probably triggered by the visual system.

Introduction The BIG project (‘Bewegung als Investition in die Gesundheit’, ie, ‘Movement as Investment in Health’) was developed in 2005 as a community-based participatory research programme to offer accessible opportunities for physical activity to women in difficult life situations. Since then, the programme has been expanded to eight sites in Germany. A systematic evaluation of BIG is currently being conducted. As part of this effort, we strive to understand the preferences of participating women for different aspects of the programme, and to analyse their willingness to pay.Methods and analysis In this protocol, we describe the development and analysis plan of a discrete choice experiment (DCE) to investigate participants’ preferences for a physical activity programme for women in difficult life situations. The experiment will be embedded in a questionnaire covering several aspects of participation in the programme (eg, reach, efficacy and further effects) and the socioeconomic characteristics of all active participants. After a thorough search of the literature, BIG documents review and expert interviews, we identified five important attributes of the programme: course times, travel time to the course venue, additional social activities organised by BIG, consideration of wishes and interests for the further planning of courses and costs per course unit. Thereafter, we piloted the experiment with a sample of participants from the target group. After data collection, the experiment will be analysed using a conditional logit model and a latent class analysis to assess eventual heterogeneity in preferences.Ethics and dissemination Understanding women’s preferences will provide useful insights for the further development of the programme and ultimately increase participation and retention. The questionnaire, the included DCE and the pretest on participants received ethical approval (application no. 20-247_1-B). We plan to disseminate the results of the DCE in peer-reviewed journals, national conferences and among participants and programme coordinators and organisers.

Introduction: While invasive and associated with risks, metabolic and bariatric surgery (MBS) can promote sustained weight loss and substantial health benefits in youths with extreme obesity. The path toward informed decision making for or against MBS is poorly characterized and postoperative follow-up to assess risks and benefits is inconsistent. In youths with extreme obesity, we aimed to evaluate decision making toward MBS, as well as MBS outcomes and adherence with follow-up and recommendations in the setting of a structured pre- and post-MBS program. Methods: Participants were recruited in the setting of the multicenter “Youth with Extreme Obesity Study” (YES). YES is a cohort study in adolescents and young adults aged 14–24 years with obesity (BMI ≥30.0 kg/m2) who were recruited at four medical centers and one job center in Germany between 2012 and 2018. Participants at two medical centers with BMI ≥35 kg/m2, aged 14–24 years, and interested in pursuing MBS were included in the subproject 3 “Safety and effectiveness of weight loss surgery in adolescents with severe obesity within a structured pre- and post-surgery treatment program – an observational study” that comprised a 2-months pre- and 12-months post-MBS program. Results: Twenty-eight of 169 youths (17%) with BMI ≥35 kg/m2 were interested in MBS. Twenty-six fulfilled published eligibility criteria for MBS and participated in the structured pre-MBS preparation program. Of these, 9 participants (2 females) decided against, and 17 (n = 11 females) decided for MBS (sleeve gastrectomy). The 12-month follow-up rate was high (16/17 [94%]) and all participants achieved significant weight reduction (ΔBMI: −16.1 ± 5.6 kg/m2). Eleven of 16 participants (69%) reported taking the prescribed dietary supplements in the first year after MBS, but only five of them (31%) did so daily. In contrast to the high 12-month retention rate, follow-up after completion of the structured program was low at 24-months (9/16 [56%]) and at 36-months (5/15 [36%]), respectively. Conclusion: Participants demonstrated active decision making for or against MBS and high adherence with the structured pre- and 12 months post-MBS program, but participation was low thereafter. These findings endorse the need for longer term structured post-MBS programs to capture long-term outcomes and provide adequate care in this vulnerable group at the transition to adulthood.

Abstract Introduction Treatments of interstitial lung diseases (ILDs) mainly focus on disease stabilization and relief of symptoms by managing inflammation or suppressing fibrosis by (in part costly) drugs. To highlight economic burden of drug treatment in different ILD-subtypes we assessed cost trends and therewith-associated drivers. Methods Using data from the German, observational HILDA study we estimated adjusted mean medication costs over 36-month intervals using one- and two-part Generalized Estimating Equation (GEE) regression models with a gamma distribution and log link. Next, we determined factors associated with costs. Results In Idiopathic pulmonary fibrosis (IPF) mean per capita medication costs increased from €1442 before to €11,000€ at the end of study. In non-IPF subtypes, the increase took place at much lower level. Mean per capita ILD-specific medication costs at the end of the study ranged between €487 (other ILD) and €9142 (IPF). At baseline, higher FVC %predicted values were associated with lower medication costs in IPF (−9%) and sarcoidosis (−1%). During follow up higher comorbidity burden escalated costs in progressive fibrosing ILD (PF-ILD) (+52%), sarcoidosis (+60%) and other ILDs (+24%). The effect of disease duration was not uniform, with cost savings in PF-ILD (−8%) and sarcoidosis (−6%), but increased spending in IPF (+11%). Conclusion Pharmacological management of ILD, in particular of IPF imposes a substantial economic burden on the healthcare system. Strategies to reduce comorbidity burden and early treatment may reduce the impact of ILDs on the healthcare system.

Abstract Background Health-related quality of life (HRQL) in interstitial lung disease (ILD) patients is impaired. We aimed to identify baseline predictors for HRQL decline within a 12-month observation period. Methods We analyzed 194 ILD patients from two German ILD-centers in the observational HILDA study. We employed the disease-specific King’s Brief Interstitial Lung Disease questionnaire (K-BILD) with the subdomains ‘psychological impact’, ‘chest symptoms’ and ‘breathlessness and activities’, and the generic EQ-5D Visual Analog Scale (VAS). We evaluated how many patients experienced a clinically meaningful decline in HRQL. Subsequently, we investigated medical and sociodemographic factors as potential predictors of HRQL deterioration. Results Within the study population (34.0% male, Ø age 61.7) mean HRQL scores hardly changed between baseline and follow up (K-BILD: 52.8 vs. 52.5 | VAS: 60.0 vs. 57.3). On the intra-individual level, 30.4% (n = 59) experienced a clinically relevant deterioration in K-BILD total score and 35.4% (n = 68) in VAS. Lower baseline forced vital capacity (FVC) % predicted determined HRQL decline in K-BILD total score (ß-coefficient: − 0.02, p = 0.007), VAS (ß-coefficient: − 0.03, p

Abstract Background Forced expiratory volume in one second (FEV1) characterizes the pathophysiology of COPD and different trajectories of FEV1 decline have been observed in patients with COPD (e.g. gradual or episodic). There is limited information about the development of patient-reported health-related quality of life (HRQL) over the full range of the natural history of COPD. We examined the longitudinal association between change in FEV1 and change in disease-specific and generic HRQL. Methods We analysed data of 1734 patients with COPD participating in the COSYCONET cohort with up to 3 years of follow-up. Patients completed the Saint George’s Respiratory Questionnaire (SGRQ) and the EQ-5D Visual Analog Scale (EQ VAS). Change score models were used to investigate the relationship between HRQL and FEV1 and to calculate mean changes in HRQL per FEV1 change categories [decrease (≤ − 100 ml), no change, increase (≥ 100 ml)] after 3 years. Applying hierarchical linear models (HLM), we estimated the cross-sectional between-subject difference and the longitudinal within-subject change of HRQL as related to a FEV1 difference or change. Results We observed a statistically significant deterioration in SGRQ (total score + 1.3 units) after 3 years, which was completely driven by the activity component (+ 4 units). No significant change was found for the generic EQ VAS. Over the same period, 58% of patients experienced a decrease in FEV1, 28% were recorded as no change in FEV1, and 13% experienced an increase. The relationship between HRQL and FEV1 was found to be approximately linear with decrease in FEV1 being statistically significantly associated with a deterioration in SGRQ (+ 3.20 units). Increase in FEV1 was associated with improvements in SGRQ (− 3.81 units). The associations between change in FEV1 and the EQ VAS were similar. Results of the HLMs were consistent and highly statistically significant, indicating cross-sectional and longitudinal associations. The largest estimates were found for the association between FEV1 and the SGRQ activity domain. Conclusions Difference and change in FEV1 over time correlate with difference and change in disease-specific and generic HRQL. We conclude, that deterioration of HRQL should induce timely re-examination of physical status and lung function and possibly reassessment of therapeutic regimes. Trial registration NCT01245933 . Date of registration: 18 November 2010.

Background The Munich Breathlessness Service has adapted novel support services to the German context, to reduce burden in patients and carers from breathlessness in advanced disease. It has been evaluated in a pragmatic fast-track randomised controlled trial (BreathEase; NCT02622412) with embedded qualitative interviews and postal survey. The aim of this article is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field. Methods Analysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers. Results Out of 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 (42%) people did not qualify for inclusion, mostly because breathlessness could not be attributed to an underlying disease. All participants were self-referring; 60% through media sources. Eligibility and willingness to participate were associated to social networks and illness-related activities as recruitment routes. Mean age of participants was 71 years (51% women), with COPD (63%), chronic heart failure (8%), interstitial lung disease (9%), pulmonary hypertension (6%) and cancer (7%) as underlying conditions. Postal survey response rate was 89%. Qualitative interviews were conducted with 16 patients and nine carers. Conclusion The BreathEase study has a larger and more heterogeneous sample compared to other trials. The self-referral-based and prolonged recruitment drawing on media sources approximates real-world conditions of early palliative care. Integrating qualitative and quantitative components will allow a better understanding and interpretation of the results of the main effectiveness study.

Abstract Background Risk attitudes influence decisions made under uncertainty. This paper investigates the association of risk attitudes with the utilization of preventive and general healthcare services, work absence and resulting costs to explore their contribution to the heterogeneity in utilization. Methods Data of 1823 individuals (56.5 ± 9.5 years), participating in the German KORA FF4 population-based cohort study (2013/2014) were analyzed. Individuals’ general and health risk attitude were measured as willingness to take risk (WTTR) on 11-point scales. Utilization of preventive and medical services and work absence was assessed and annual costs were calculated from a societal perspective. Generalized linear models with log-link function (logistic, negative-binomial and gamma regression) adjusted for age, sex, and height were used to analyze the association of WTTR with the utilizations and costs. Results Higher WTTR was significantly associated with lower healthcare utilization (physician visits, physical therapy, and medication intake), work absence days and indirect costs. Regarding preventive services, an overall negative correlation between WTTR and utilization was examined but this observation remained non-significant except for the outcome medical check-up. Here, higher WTTR was significantly associated with a lower probability of participation. For all associations mentioned, Odds Ratios ranged between 0.90 and 0.79, with p

Abstract Background Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3–5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID). Methods Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches. Results The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21. Conclusion It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients. Trial registration The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov (NCT02951416).

Introduction: Community-based participatory research (CBPR) is considered to be of high potential for health promotion among socially disadvantaged groups. However, the long-term implementation and transfer of these approaches remain challenging, and the public health impact they achieve is difficult to study. This also pertains to the potential health effects and cost-effectiveness of CBPR. This study protocol describes the follow-up case study (NU-BIG) after 15 years of the BIG project (“movement as investment in health”), a project to promote physical activity among socially disadvantaged women. Through a participatory approach, BIG empowers the addressed women to plan and implement low-threshold physical activity offers. Since the project started in 2005, it was transferred to 17 communities in Germany.Materials and Analysis: NU-BIG intends to examine the long-term effects, including economic aspects, of the BIG project on individual and structural levels at all project sites, as well as its long-term implementation and transfer. NU-BIG is a cross-sectional and longitudinal study using a mixed method approach. For the longitudinal section, we re-analyze existing data from former BIG evaluations. For cross-sectional data collection, we use questionnaires and conduct qualitative interviews and focus groups. Women who take part in BIG program offers are part of the research team and will use the photo-voice approach to report on the effects of BIG. The study population consists of about 800 women who participate in BIG project offers and 50 persons involved in the implementation of the BIG project at local sites.Discussion: The expected results from NU-BIG are highly relevant for studying the long-term public health impact of CBPR. In particular, this project intends to answer questions on how the transfer of such projects can succeed and which factors determine if a CBPR project can be sustained at the community level. Eventually, these results can contribute to the further development of participatory approaches to provide effective health promotion among socially disadvantaged groups.Conclusion: Although CBPR is seen of having the potential to reduce health disparities, there is still a lack of research on its long-term effects and public health impact. NU-BIG aims at generating knowledge about the economic effects, reach, efficacy, adoption, implementation, and maintenance of a CBPR project. The expected results could be of high interest for BIG and other CBPR-projects.

Abstract Background and aims Unrealistic comparative optimism (UO), as the erroneous judgement of personal risks to be lower than the risks of others, could help explain differences in diabetes self‐management. The present study tested the hypothesis that individuals with type 2 diabetes who underestimate their comparative heart attack risk, have a lower adherence regarding recommended self‐management. Methods We used data from individuals with type 2 diabetes participating in the German KORA (Cooperative Health Research in the Region of Augsburg) GEFU 4 (self‐administered health questionnaire 2016) study. UO was estimated by comparing participants' subjective comparative risk for having a heart attack within the next 5‐years (ie, “higher than others,” “average,” “lower than others”), with their objective comparative 10‐year cardiovascular disease risk based on the Framingham equations. We estimated binary logistic and linear regression models to analyze which characteristics were associated with UO and to test the association between UO and participants' self‐management behaviors (ie, regular self‐monitoring of body weight, blood sugar, and blood pressure, regular foot care, keeping a diabetes diary, and having a diet plan), and their sum score, respectively. All models were adjusted for socio‐demographic and disease‐related variables. Results The studied sample included n = 633 individuals with type 2 diabetes (mean age 70.7 years, 45% women). Smokers and males were more likely to show UO than nonsmokers and females. Furthermore, a higher blood pressure and a higher body mass index were associated with a higher likelihood of UO regarding heart attack risk. However, UO was not significantly associated with patient self‐management. Conclusions Unfavorable health behavior and risk factors are associated with UO. However, our results suggest that UO with regard to perceived heart attack risk may not be a relevant factor for patient self‐management in those with type 2 diabetes.

Abstract Background By performing case management, general practitioners and health care assistants can provide additional benefits to their chronically ill patients. However, the economic effects of such case management interventions often remain unclear although how to manage the burden of chronic disease is a key question for policy-makers. This analysis aimed to compare the cost-effectiveness of 24 months of primary care case management for patients with a long-term indication for oral anticoagulation therapy with usual care. Methods This analysis is part of the cluster-randomized controlled Primary Care Management for Optimized Antithrombotic Treatment (PICANT) trial. A sample of 680 patients with German statutory health insurance was initially considered for the cost analysis (92% of all participants at baseline). Costs included all disease-related direct health care costs from the payer’s perspective (German statutory health insurers) plus case management costs for the intervention group. A-Quality Adjusted Life Year (QALY) measurement (EQ-5D-3 L instrument) was used to evaluate utility, and incremental cost-effectiveness ratio (ICER) to assess cost-effectiveness. Mean differences were calculated and displayed with 95%-confidence intervals (CI) from non-parametric bootstrapping (1000 replicates). Results N = 505 patients (505/680, 74%) were included in the cost analysis (complete case analysis with a follow-up after 12 and 24 months as well as information on cost and QALY). After two years, the mean difference of direct health care costs per patient (€115, 95% CI [− 201; 406]) and QALYs (0.03, 95% CI [− 0.04; 0.11]) in the two groups was small and not significant. The costs of case management in the intervention group caused mean total costs per patient in this group to rise significantly (mean difference €503, 95% CI [188; 794]). The ICER was €16,767 per QALY. Regardless of the willingness of insurers to pay per QALY, the probability of the intervention being cost-effective never rose above 70%. Conclusions A primary care case management for patients with a long-term indication for oral anticoagulation therapy improved QALYs compared to usual care, but was more costly. However, the results may help professionals and policy-makers allocate scarce health care resources in such a way that the overall quality of care is improved at moderate costs, particularly for chronically ill patients. Trial registration Current Controlled Trials ISRCTN41847489.

Abstract Background Physical inactivity (PIA) is an important risk factor for many chronic conditions and therefore might increase healthcare utilization and costs. This study aimed to analyze the association of PIA using device assessed and self-reported physical activity (PA) data with direct healthcare costs. Methods Cross-sectional data was retrieved from the population based KORA FF4 study (Cooperative Health Research in the Region of Augsburg) that was conducted in southern Germany from 2013 to 2014 (n = 2279). Self-reported PA was assessed with two questions regarding sports related PA in summer and winter and categorized into “high activity”, “moderate activity”, “low activity” and “no activity”. In a subsample (n = 477), PA was assessed with accelerometers and participants were categorized into activity quartiles (“very high”, “high”, “low” and “very low”) according to their mean minutes per day spent in light intensity, or in moderate-vigorous PA (MVPA). Self-reported healthcare utilization was used to estimate direct healthcare costs. We regressed direct healthcare costs on PA using a two-part gamma regression, adjusted for age, sex and socio-demographic variables. Additional models, including and excluding potential additional confounders and effect mediators were used to check the robustness of the results. Results Annual direct healthcare costs of individuals who reported no sports PA did not differ from those who reported high sports PA [+€189, 95% CI: -188, 598]. In the subsample with accelerometer data, participants with very low MVPA had significantly higher annual costs than participants with very high MVPA [+€986, 95% CI: 15, 1982]. Conclusion Device assessed but not self-reported PIA was associated with higher direct healthcare costs. The magnitude and significance of the association depended on the choice of covariates in the regression models. Larger studies with device assessed PA and longitudinal design are needed to be able to better quantify the impact of PIA on direct healthcare costs.

Abstract Background The current health system reforms in Kosovo aim to improve health status through universal health coverage. Risk pooling and ensuring access to necessary care without financial hardship are envisaged through compulsory health insurance. We measure the level of financial risk protection through two commonly applied concepts: catastrophic health expenditures and impoverishment. Methods Data from the 2014 Kosovo Household Budget Survey were used to estimate catastrophic health expenditures as a percentage of household consumption expenditures at different thresholds. Poverty head counts and gaps were estimated before and after out-of-pocket (OOP) health payments. Results Approximately 80% of the households in Kosovo incurred OOP health payments. Most of these expenditures were for medicine, pharmaceutical products and medical devices, followed by diagnostic and outpatient services. Hospital services and treatment abroad were less frequent but highly costly. Although households from the upper consumption groups spent more, households from the lower consumption groups spent a greater share of their consumption expenditures on healthcare. The catastrophic health expenditure head count showed an increase, while the impoverishment and poverty gap remained stable compared to 2011. Regression analysis showed that age of the household head, insurance coverage, household size, belonging to the lowest consumption expenditure quintiles, and having disabled and aged household members were significant predictors of the probability of experiencing catastrophic health expenditures. Conclusions Ongoing financing reforms should target the lower income quintiles and vulnerable groups, pharmaceutical policies should be revisited, and the internal referral system should be strengthened to overcome excessive spending for treatment abroad.

Abstract Background Societies around the world face the burden of an aging population with a high prevalence of chronic conditions. Thus, the demand for different types of long-term care will increase and change over time. The purpose of this exploratory study was to identify determinants for utilization and transitions of long-term care in adults older than 65 years by using Andersen’s Behavioral Model of Health Services Use. Methods The study examined individuals older than 65 years between 2011/2012 (t1) and 2016 (t2) from the population-based Cooperative Health Research in the Region of Augsburg (KORA)-Age study from Southern Germany. Analyzed determinants consisted of predisposing (age, sex, education), enabling (living arrangement, income) and need (multimorbidity, disability) factors. Generalized estimating equation logistic models were used to identify determinants for utilization and types of long-term care. A logistic regression model examined determinants for transitions to long-term care over four years through a longitudinal analysis. Results We analyzed 810 individuals with a mean age of 78.4 years and 24.4% receiving long-term care at t1. The predisposing factors higher age and female sex, as well as the need factors higher multimorbidity and higher disability score, were determinants for both utilization and transitions of long-term care. Living alone, higher income and a higher disability score had a significant influence on the utilization of formal versus informal long-term care. Conclusion Our results emphasize that both utilization and transitions of long-term care are influenced by a complex construct of predisposing, enabling and need factors. This knowledge is important to identify at-risk populations and helps policy-makers to anticipate future needs for long-term care. Trial registration Not applicable

Abstract Background Adherence to recommendations and medication is deemed to be important for effectiveness of case management interventions. Thus, reasons for non-adherence and effects on health-related quality of life (HRQoL) should be fully understood. The objective of this research was to identify determinants of non-adherence to medication and recommendations, and to test whether increased adherence improved HRQoL in patients after myocardial infarction (MI) in a case management intervention. Methods Data were obtained from the intervention group of the KORINNA study, a randomized controlled trail of a nurse-led case management intervention with targeted recommendations in the elderly after MI in Germany. Reasons for non-adherence were described. Logistic mixed effects models and OLS (ordinary least squares) were used to analyze the effect of recommendations on the probability of adherence and the association between adherence and HRQoL. Results One hundred and twenty-seven patients with 965 contacts were included. Frequent reasons for non-adherence to medication and recommendations were “forgotten” (22%; 11%), “reluctant” (18%; 18%), “side effects” (38%; 7%), “the problem disappeared” (6%; 13%), and “barriers” (0%; 13%). The probability of adherence was lowest for disease and self-management (38%) and highest for visits to the doctor (61%). Only if patients diverging from prescribed medication because of side effects were also considered as adherent, 3-year medication adherence was associated with a significant gain of 0.34 quality-adjusted life years (QALYs). Conclusions Most important determinants of non-adherence to medication were side effects, and to recommendations reluctance. Recommended improvements in disease and self-management were least likely adhered. Medication adherence was associated with HRQoL. Trial registration Current Controlled Trials ISRCTN02893746, retrospectively registered, date assigned 27/03/2009.

Abstract Background A number of prior studies have examined the association between anthropometric measures and mortality, but studies investigating the sex-specific predictive value of novel anthropometric measures on mortality are scarce so far. Therefore, we investigated the sex-specific relevance of the new anthropometric measures body adiposity index (BAI) and waist to height ratio (WHtR) as well as the common measures body mass index (BMI), waist circumference (WC), and waist to hip ratio (WHR) for cause-specific mortality risk. Methods The analysis was based on data from the German population based KORA (Cooperative Health Research in the Region of Augsburg) Augsburg cohort study. A total of 6670 men and 6637 women aged 25 to 74 years at baseline examination were included. During a mean follow-up period of 15.4 years, 2409 persons died. Via Cox proportional hazard regression, the associations between the different anthropometric measures and all cause-, cardiovascular disease (CVD)- and cancer mortality were assessed. Results BMI, WC, and WHR were significantly associated with all-cause and CVD-mortality in both sexes. WC and WHR were particularly associated with higher all-cause and CVD-mortality risk in women, while in men especially WHtR and BAI were strongly related to these outcomes. Females with WC, WHtR, and WHR measures in the 4th quartile compared with women in the 2nd quartile had a higher risk of death from cancer. Contrary, men in the lowest quartile of WC and WHtR in comparison to men in the 2nd quartile had a significantly elevated cancer mortality risk. BAI was no risk predictor for all-cause and cause-specific mortality in women. Conclusions Central obesity reflects higher all-cause and CVD-mortality risk particularly in women. BAI and WHtR seem to be valid as risk predictors for all-cause and especially CVD mortality in men but not women. There are marked sex-differences regarding cancer mortality risk for the different anthropometric measures.

Abstract Background The relationship of spirometric values to other respiratory and functional parameters in advanced age is not well studied. We assessed this relationship in elderly subjects with either good or poor spirometric parameters to reveal whether different domains of lung function show comparable differences between the two groups. Methods Among subjects of the population-based KORA-Age cohort (n = 935, 65-90y; 51% male) two groups were selected from either the lower (LED; n = 51) or the upper (UED; n = 72) end of the FEV1 distribution. All subjects did not have a history of lung disease and were non-smokers at the time of the study. Measurements included spirometry, body plethysmography, diffusing capacity for NO and CO, respiratory pump function and exhaled NO (FeNO). In addition, 6-min walking distance as a functional overall measure, as well as telomere length of blood leukocytes and serum 8-hydroxydeoxyguanosine (8-OHdG) as potential markers of overall biological ageing and stress were determined. Results In the majority of parameters, LED subjects showed significantly impaired values compared to UED subjects. Differences in spirometric parameters, airway resistance and respiratory pump function ranged between 10% and more than 90% in terms of predicted values. In contrast, volume-related CO and NO diffusing capacity showed differences between groups of lower than 5%, while telomere length, 8-OHdG and FeNO were similar. This was reflected in the differences in “functional age” as derived from prediction equations. Conclusions In elderly subjects without a history of lung disease differences in spirometric parameters were associated with differences in other lung-mechanical parameters including body plethysmography but not with differences in volume-corrected gas exchange measures. Thus, the concept of a general “lung age” as suggested by the widespread use of this term in connection with spirometry should be considered with caution.

Abstract Background In lung disease, physical activity (PA) yields beneficial health effects, but its association with the function of healthy lungs has rarely been studied. We investigated the association of accelerometer-based PA with spirometric indices, maximal inspiratory mouth pressure (PImax) and lung diffusion capacity in lung-healthy adults. Methods In total, 341 apparently lung-healthy participants from the population-based KORA (Cooperative Health Research in the Region of Augsburg) FF4 cohort study (45% male, aged 48-68 years, 47% never smokers) completed lung function testing and wore ActiGraph accelerometers over a one week period at the hip. In adjusted regression analyses, moderate to vigorous PA (MVPA) was characterized as: sex-specific activity quartiles, achieving ≥ 10 consecutive minutes (yes vs. no), and meeting the WHO PA recommendations (yes vs. no). Results Positive associations of MVPA-quartiles with forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and corresponding Global Lung Function Initiative z-scores were found. Subjects in the most active quartile (> 47 or > 50 min/day for females and males, respectively) had 142 ml [95% CI: 23, 260] higher FEV1 and 155 ml [95% CI: 10, 301] higher FVC than those in the least active quartile (

Background: To compare efficacy and safety of a manual-based low-level psychological intervention with treatment as usual (weight loss treatment). Methods: A two-armed randomized controlled trial without blinding and computer-based stratified block randomization included adolescents and young adults (14.0-24.9 years) with a BMI ≥ 30 kg/m2 at five German university hospitals. Primary outcomes were adherence (participation rate ≥ 5/6 sessions) and quality of life (DISABKIDS-37) 6 months after randomization. Secondary outcomes included depression, self-esteem, and perceived stress scores. Results: Of 397 screened adolescents, 119 (mean BMI 40.4 ± 7.0 kg/m2, 49.6% female) were randomized to the manual-based low-level intervention (n = 59) or treatment as usual (n = 60). We observed no group difference for adherence (absolute risk reduction 0.4%, 95% CI -14.7% to 15.5%; p = 1.0) or health-related quality of life (score difference 8.1, 95% CI -2.1 to 18.3; p = 0.11). Among all secondary outcomes, we detected explorative evidence for an effect on the DISABKIDS-37 ‘social exclusion' subscale (score difference 15.5; 95% CI 1.6-29.4; p = 0.03). 18/19 adverse events occurred in 26 participants, none were classified as serious. Conclusion: Adherence to a coping-oriented intervention was comparable to weight loss treatment, although it was weak in both interventions. Psychological interventions may help to overcome social isolation; further confirmation is required.

Abstract Background Alpha-1-Antitrypsin Deficiency (AATD) is an economically unexplored genetic disease. Methods Direct and indirect costs (based on self-reported information on healthcare utilization) and health-related quality of life (HRQL, as assessed by SGRQ, CAT, and EQ-5D-3 L) were compared between 131 AATD patients (106 with, 25 without augmentation therapy (AT)) and 2,049 COPD patients without AATD participating in the COSYCONET COPD cohort. The medication costs of AT were excluded from all analyses to reveal differences associated with morbidity profiles. The association of AATD (with/without AT) with costs or HRQL was examined using generalized linear regression modelling (GLM) adjusting for age, sex, GOLD grade, BMI, smoking status, education and comorbidities. Results Adjusted mean direct annual costs were €6,099 in AATD patients without AT, €7,117 in AATD patients with AT (excluding costs for AT), and €7,460 in COPD patients without AATD. AATD with AT was significantly associated with higher outpatient (+273%) but lower inpatient (−35%) and medication costs (−10%, disregarding AT) compared with COPD patients without AATD. There were no significant differences between groups regarding indirect costs and HRQL. Conclusion Apart from AT costs, AATD patients tended to have lower, though not significant, overall costs and similar HRQL compared to COPD patients without AATD. AT was not associated with lower costs or higher HRQL. Trial registration NCT01245933

Aims: This claims data-based study compares the intensity of diabetes care in community dwellers and nursing home residents with dementia. Methods: Delivery of diabetes-related medical examinations (DRMEs) was compared via logistic regression in 1,604 community dwellers and 1,010 nursing home residents with dementia. The intra-individual effect of nursing home transfer was evaluated within mixed models. Results: Delivery of DRMEs decreases with increasing care dependency, with more community-living individuals receiving DRMEs. Moreover, DRME provision decreases after nursing home transfer. Conclusion: Dementia patients receive fewer DRMEs than recommended, especially in cases of higher care dependency and particularly in nursing homes. This suggests lacking awareness regarding the specific challenges of combined diabetes and dementia care.

Objective: To estimate the excess costs of obese compared to normal-weight persons in Germany based on self-reported resource utilisation and work absence. Methods: Five cross sectional surveys of cohort studies in southern Germany were pooled resulting in 9,070 observations for 6,731 individuals (31-96 years). BMI was measured in the study centre. Self-reported health care utilisation and work absence was used to estimate direct and indirect costs for the year 2011 based on unit costs. Using regression analyses, adjusted costs for different BMI groups were calculated. Results: Overweight and obese people showed significantly higher odds of health care utilisation and productivity losses compared with normal-weight people in most categories. Total direct/indirect costs were significantly higher with increasing severity of obesity (pre-obese (1.05 (0.90-1.23) / 1.38 (1.11-1.71)), obesity level I (1.18 (1.00-1.39) / 1.33 (1.02-1.73)), obesity level II (1.46 (1.14-1.87) / 1.77 (1.18-2.65)) or level III (2.04 (1.40-2.97) / 1.99 (1.20-3.30)) compared to normal-weight participants. In particular, higher obesity classes were significantly associated with increased costs for medication, general practitioner utilisation and work absence. Conclusion: Our results show that overweight and obesity are associated with enormous societal direct and indirect costs in Germany. This supports the evidence from previous top-down studies, but provides important new information based on a large pooled data set and measured BMI.

Abstract Background Creating study identifiers and assigning them to study participants is an important feature in epidemiologic studies, ensuring the consistency and privacy of the study data. The numbering system for identifiers needs to be random within certain number constraints, to carry extensions coding for organizational information, or to contain multiple layers of numbers per participant to diversify data access. Available software can generate globally-unique identifiers, but identifier-creating tools meeting the special needs of epidemiological studies are lacking. We have thus set out to develop a software program to generate IDs for epidemiological or clinical studies. Results Our software IDGenerator creates unique identifiers that not only carry a random identifier for a study participant, but also support the creation of structured IDs, where organizational information is coded into the ID directly. This may include study center (for multicenter-studies), study track (for studies with diversified study programs), or study visit (baseline, follow-up, regularly repeated visits). Our software can be used to add a check digit to the ID to minimize data entry errors. It facilitates the generation of IDs in batches and the creation of layered IDs (personal data ID, study data ID, temporary ID, external data ID) to ensure a high standard of data privacy. The software is supported by a user-friendly graphic interface that enables the generation of IDs in both standard text and barcode 128B format. Conclusion Our software IDGenerator can create identifiers meeting the specific needs for epidemiologic or clinical studies to facilitate study organization and data privacy. IDGenerator is freeware under the GNU General Public License version 3; a Windows port and the source code can be downloaded at the Open Science Framework website: https://osf.io/urs2g/ .

BackgroundAlthough lung cancer is most commonly diagnosed in elderly patients, evidence about tumor-directed therapy in elderly patients is sparse, and it is unclear to what extent this affects treatment and care. Our study aimed to discover potential disparities in care between elderly patients and those under 65 years of age.MethodsWe studied claims from 13 283 German patients diagnosed with lung cancer in 2009 who survived for at least 90 days after diagnosis. We classified patients as "non-elderly" (≤ 65), "young-old" (65-74), "middle-old" (75-84), and "old-old" (≥ 85). We compared receipt of tumor-directed therapy (6 months after diagnosis), palliative care, opioids, antidepressants, and pathologic diagnosis confirmation via logistic regression. We used generalized linear regression (gamma distribution) to compare group-specific costs of care for 3 months after diagnosis. We adjusted all models by age, nursing home residency, nursing care need, comorbidity burden, and area of residence (urban, rural). The age group "non-elderly" served as reference group.ResultsCompared with the reference group "non-elderly", the likelihood of receiving any tumor-directed treatment was significantly lower in all age groups with a decreasing gradient with advancing age. Elderly lung cancer patients received significantly fewer resections and radiotherapy than non-elderly patients. In particular, treatment with antineoplastic therapy declined with increasing age ("young-old" (OR = 0.76, CI = [0.70,0.83]), "middle-old" (OR = 0.45, CI = [0.36,0.50]), and "old-old" (OR = 0.13, CI = [0.10,0.17])). Patients in all age groups were less likely to receive structured palliative care than "non-elderly" ("young-old" (OR = 0.84, CI = [0.76,0.92]), "middle-old" (OR = 0.71, CI = [0.63,0.79]), and "old-old" (OR = 0.57, CI = [0.44,0.73])). Moreover, increased age was significantly associated with reduced quotas for outpatient treatment with opioids and antidepressants. Costs of care decreased significantly with increasing age.ConclusionThis study suggests the existence of age-dependent care disparities in lung cancer patients, where elderly patients are at risk of potential undertreatment. To support equal access to care, adjustments to public health policies seem to be urgently required.

Objective: Uni- or bilateral vestibular hypofunction (VH) impairs balance and mobility, and may specifically lead to injury from falls and to disability. The extent of this problem in the general population is still unknown and most likely to be underestimated. Objective of this study was to determine the prevalence, determinants, and consequences of VH in the general population.Methods: Data originates from the cross-sectional second follow-up (FF4) in 2013/14 of the KORA (Cooperative Health Research in the Region of Augsburg)-S4 study (1999–2001) from Southern Germany. This was a random sample of the target population consisting of all residents of the region aged 25–74 years in 1999. We included all participants who reported moderate or severe vertigo or dizziness during the last 12 months and a random sub-sample of participants representative for the general population without vertigo or dizziness during the last 12 months were tested. VH was assessed with the Video-Head Impulse Test (vHIT). Trained examiners applied high-acceleration, small-amplitude passive head rotations (“head impulses”) to the left and right in the plane of the horizontal semicircular canals while participants fixated a target straight ahead. During head impulses, head movements were measured with inertial sensors, eye movements with video-oculography (EyeSeeCam vHIT).Results: A total of 2,279 participants were included (mean age 60.8 years, 51.6% female), 570 (25.0%) with moderate or severe vertigo or dizziness during the last 12 months. Of these, 450 were assessed with vHIT where 26 (5.8%) had unilateral VH, and 16 (3.6%) had bilateral VH. Likewise, 190 asymptomatic participants were tested. Of these 5 (2.6%) had unilateral VH, and 2 (1.1%) had bilateral VH. Prevalence of uni- or bilateral VH among tested symptomatic participants was 2.4% in those < 48 years, and 32.1% in individuals aged 79 and over. Age-adjusted prevalence was 6.7% (95% CI 4.8%; 8.6%). VH was associated with worse health, falls, hearing loss, hearing impairment, and ear pressure.Conclusion: VH may affect between 53 and 95 million adults in Europe and the US. While not all affected persons will experience the full spectrum of symptoms and consequences, adequate diagnostic and therapeutic measures should become standard of care to decrease the burden of disease.

Objective: The video head impulse test (vHIT) has become a common examination in the work-up for dizziness and vertigo. However, recent studies suggest a number of pitfalls, which seem to reduce vHIT usability. Within the framework of a population-based prospective study with naïve examiners, we investigated the relevance of previously described technical mistakes in vHIT testing, and the effect of experience and training.Methods: Data originates from the KORA (Cooperative Health Research in the Region of Augsburg) FF4 study, the second follow-up of the KORA S4 population-based health survey. 681 participants were selected in a case-control design. Three examiners without any prior experience were trained in video head impulse testing. VHIT quality was assessed weekly by an experienced neuro-otologist. Restrictive mistakes (insufficient technical quality restricting interpretation) were noted. Based on these results, examiners received further individual training.Results: Twenty-two of the 681 vHITs (3.2%) were not interpretable due to restrictive mistakes. Restrictive mistakes could be grouped into four categories: slippage, i.e., goggle movement relative to the head (63.6%), calibration problems (18.2%), noise (13.6%), and low velocity of the head impulse (4.6%). The overall rate of restrictive mistakes decreased significantly during the study (12% / examiner within the first 25 tested participants and 2.1% during the rest of the examinations, p < 0.0001).Conclusion: Few categories suffice to explain restrictive mistakes in vHIT testing. With slippage being most important, trainers should emphasize the importance of tight goggles. Experience and training seem to be effective in improving vHIT quality, leading to high usability.

This population-based study sought to extend knowledge on factors explaining regional differences in type 2 diabetes mellitus medication patterns in Germany.Individual baseline and follow-up data from four regional population-based German cohort studies (SHIP [northeast], CARLA [east], HNR [west], KORA [south]) conducted between 1997 and 2010 were pooled and merged with both data on regional deprivation and regional health care services. To analyze regional differences in any or newer anti-hyperglycemic medication, medication prevalence ratios (PRs) were estimated using multivariable Poisson regression models with a robust error variance adjusted gradually for individual and regional variables.The study population consisted of 1,437 people aged 45 to 74 years at baseline, (corresponding to 49 to 83 years at follow-up) with self-reported type 2 diabetes. The prevalence of receiving any anti-hyperglycemic medication was 16% higher in KORA (PR 1.16 [1.08-1.25]), 10% higher in CARLA (1.10 [1.01-1.18]), and 7% higher in SHIP (PR 1.07 [1.00-1.15]) than in HNR. The prevalence of receiving newer anti-hyperglycemic medication was 49% higher in KORA (1.49 [1.09-2.05]), 41% higher in CARLA (1.41 [1.02-1.96]) and 1% higher in SHIP (1.01 [0.72-1.41]) than in HNR, respectively. After gradual adjustment for individual variables, regional deprivation and health care services, the effects only changed slightly.Neither comprehensive individual factors including socioeconomic status nor regional deprivation or indicators of regional health care services were able to sufficiently explain regional differences in anti-hyperglycemic treatment in Germany. To understand the underlying causes, further research is needed.

Background: Community-based and institutional dementia care has been compared in cross-sectional studies, but longitudinal information on the effect of institutionalization on health care service utilization is sparse. Methods: We analyzed claims data from 651 dementia patients via Generalized Estimation Equations to assess health care service utilization profiles and corresponding expenditures from four quarters before to four quarters after institutionalization. Results: In all domains, utilization increased in the quarter of institutionalization. Afterwards, the use of drugs, medical aids, and non-physician services (e.g., occupational therapy and physiotherapy) remained elevated, but use of in- and outpatient treatment decreased. Cost of care showed corresponding profiles. Conclusion: Institutional dementia care seems to be associated with an increased demand for supportive services but not necessarily for specialized medical care.

Background: Institutionalization is the most important milestone in the care of dementia patients. This study was aimed at identifying relevant predictors of institutionalization in a broad empirical context and interpreting them on the basis of the predictor model proposed by Luppa et al. [Dement Geriatr Cogn Disord 2008;26:65-78]. Methods: At the start of this study, 357 patients with mild to moderate dementia were examined by their general practitioners, and a telephone interview was conducted with their caregivers. Four years later, the outcomes ‘institutionalization' and ‘death' were determined from health insurance data. Forty-one variables were examined for their predictive influence by univariate and multivariate Cox regression. Results: The risk of institutionalization increased significantly (p ≤ 0.05) with older ages of patients [hazard ratio (HR) = 1.05] and caregivers (HR = 1.03), a higher educational level of the caregiver (HR = 1.83), greater use of community health services (HR = 1.59), greater caregiver burden (HR = 1.02), and when the caregiver and patient lived apart (HR = 1.97). Conclusion: The results show that there is a multifactorial influence on institutionalization of dementia patients by sociodemographic, health-related, and psychological aspects as well as the care situation, thus validating the predictor model by Luppa et al. [Dement Geriatr Cogn Disord 2008;26:65-78]. Caregiver burden was found to be the strongest predictor accessible to interventions.

Although hyperlipidemia is common in COPD, its relationship to comorbidities, risk factors and lung function in COPD has not been studied in detail. Using the baseline data of the COSYCONET cohort we addressed this question. Data from 1746 COPD patients (GOLD stage 1-4; mean age 64.6 y, mean FEV1%pred 57%) were evaluated, focusing on the comorbidities hyperlipidemia, diabetes and cardiovascular complex (CVC; including arterial hypertension, cardiac failure, ischemic heart disease). Risk factors comprised age, gender, BMI, and packyears of smoking. The results of linear and logistic regression analyses were implemented into a path analysis model describing the multiple relationships between parameters. Hyperlipidemia (prevalence 42.9%) was associated with lower intrathoracic gas volume (ITGV) and higher forced expiratory volume in 1 second (FEV1) when adjusting for its multiple relationships to risk factors and other comorbidities. These findings were robust in various statistical analyses. The associations between comorbidities and risk factors were in accordance with previous findings, thereby underlining the validity of our data. In conclusion, hyperlipidemia was associated with less hyperinflation and airway obstruction in patients with COPD. This surprising result might be due to different COPD phenotypes in these patients or related to effects of medication.

OBJECTIVE:Early detection of diabetes and prediabetic states is beneficial for patients, but may be delayed by patients´ being overly optimistic about their own health. Therefore, we assessed how persons without known diabetes perceive their risk of having or developing diabetes, and we identified factors associated with perception of diabetes risk. RESEARCH DESIGN AND METHODS:1,953 participants without previously known diabetes from the population-based, German KORA FF4 Study (59.1 years, 47.8% men) had an oral glucose tolerance test. They estimated their probability of having undiagnosed diabetes mellitus (UDM) on a six category scale, and assessed whether they were at risk of developing diabetes in the future. We cross-tabulated glycemic status with risk perception, and fitted robust Poisson regression models to identify determinants of diabetes risk perception. RESULTS:74% (95% CI: 65-82) of persons with UDM believed that their probability of having undetected diabetes was low or very low. 72% (95% CI: 69-75) of persons with prediabetes believed that they were not at risk of developing diabetes. In people with prediabetes, seeing oneself at risk of diabetes was associated with self-rated poor general health (prevalence ratio (PR) = 3.1 (95% CI: 1.4-6.8), parental diabetes (PR = 2.6, 1.9-3.4), high educational level (PR = 1.9 (1.4-2.5)), lower age (PR = 0.7, 0.6-0.8, per 1 standard deviation increase), female sex (PR = 1.2, 0.9-1.5) and obesity (PR = 1.5, 1.2-2.0). CONCLUSIONS:People with undiagnosed diabetes or prediabetes considerably underestimate their probability of having or developing diabetes. Contrary to associations with actual diabetes risk, perceived diabetes risk was lower in men, lower educated and older persons.

Longitudinal evidence on the association between physical activity (PA) or weight and health-related quality of life (HRQL) is sparse and studies describe inconclusive results. The aim of this study was to examine longitudinal associations between change in PA and HRQL as between change in weight and HRQL respectively.Analyses are based on data from the KORA S4 cohort study (1999-2001; n = 4,261, mean age 49.0 ± 13.3 years) and the two follow-up examinations (F4: 2006-2008; FF4: 2013-2014). Information on PA was collected in standardized interviews. Weight was measured objectively. Mental and physical components of HRQL were assessed via the SF-12 questionnaire. First, change in HRQL was regressed on change in PA and weight. Second, hierarchical linear models were fitted, which allowed estimation of between-subject and within-subject effects. Analyses were adjusted for the covariates sex, baseline diseases, and education.A change to a physically more active lifestyle is positively associated with physical and mental HRQL. Although weight gain is associated with impairments in physical HRQL, the data show an inverse relationship between weight gain and mental HRQL. The results were consistent for both the change score analyses and the hierarchical linear models.Our findings stress the importance of interventions on PA/weight. Nonetheless, more research is needed to reveal the causal relationship between PA/weight and HRQL.

The objective of this analysis is to compare people with prevalent type 2 diabetes, incident type 2 diabetes and without diabetes with respect to longitudinal change in health-related quality of life (HRQOL) when adjusting for baseline determinants of HRQOL.Primary baseline and follow-up data from three regional and one national population-based cohort studies in Germany were pooled for analysis. HRQOL was measured using physical and mental health summary scores (PCS and MCS) from the German version of the Short Form Health Survey with 36 or 12 items. Mean score change per observation year was compared between the three groups (prevalent diabetes, incident diabetes, no diabetes) based on linear regression models.The analysis included pooled data from 5367 people aged 45-74 years at baseline. Of these, 85.5% reported no diabetes at baseline and follow-up, 6.3% reported diabetes at both baseline and follow-up (prevalent diabetes), and 8.2% reported diabetes only at follow-up (incident diabetes). Over a mean observation period of 8.7 years, annual decline in HRQOL scores is pronounced at 0.27-0.32 (PCS) and 0.34-0.38 (MCS) in the group with prevalent diabetes compared with people without diabetes. Those with incident diabetes showed intermediate values but did not differ significantly from people without diabetes after adjustment for covariates in the full model.Compared with data from cross-sectional analysis, the HRQOL loss associated with prevalent diabetes appears to be much larger than previously assumed.

Little is known about the development of the quality of diabetes care in Germany. The aim of this study is to analyze time trends in patient self-management, physician-delivered care, medication, risk factor control, complications and quality of life from 2000 to 2014.Analyses are based on data from individuals with type 2 diabetes of the population-based KORA S4 (1999-2001, n = 150), F4 (2006-2008, n = 203), FF4 (2013/14, n = 212) cohort study. Information on patient self-management, physician-delivered care, medication, risk factor control and quality of life were assessed in standardized questionnaires and examinations. The 10-year coronary heart disease (CHD) risk was calculated using the UKPDS risk engine. Time trends were analyzed using multivariable linear and logistic regression models adjusted for age, sex, education, diabetes duration, and history of cardiovascular disease.From 2000 to 2014 the proportion of participants with type 2 diabetes receiving oral antidiabetic/cardio-protective medication and of those reaching treatment goals for glycemic control (HbA1c

In large cohort studies comorbidities are usually self-reported by the patients. This way to collect health information only represents conditions known, memorized and openly reported by the patients. Several studies addressed the relationship between self-reported comorbidities and medical records or pharmacy data, but none of them provided a structured, documented method of evaluation. We thus developed a detailed procedure to compare self-reported comorbidities with information on comorbidities derived from medication inspection. This was applied to the data of the German COPD cohort COSYCONET.Approach I was based solely on ICD10-Codes for the diseases and the indications of medications. To overcome the limitations due to potential non-specificity of medications, Approach II was developed using more detailed information, such as ATC-Codes specific for one disease. The relationship between reported comorbidities and medication was expressed by a four-level concordance score.Approaches I and II demonstrated that the patterns of concordance scores markedly differed between comorbidities in the COSYCONET data. On average, Approach I resulted in more than 50% concordance of all reported diseases to at least one medication. The more specific Approach II showed larger differences in the matching with medications, due to large differences in the disease-specificity of drugs. The highest concordance was achieved for diabetes and three combined cardiovascular disorders, while it was substantial for dyslipidemia and hyperuricemia, and low for asthma.Both approaches represent feasible strategies to confirm self-reported diagnoses via medication. Approach I covers a broad spectrum of diseases and medications but is limited regarding disease-specificity. Approach II uses the information from medications specific for a single disease and therefore can reach higher concordance scores. The strategies described in a detailed and reproducible manner are generally applicable in large studies and might be useful to extract as much information as possible from the available data.

Home-based secondary prevention programs led by nurses have been proposed to facilitate patients' adjustment to acute myocardial infarction (AMI). The objective of this study was to conduct secondary analyses of the three-year follow-up of a nurse-based case management for elderly patients discharged from hospital after an AMI.In a single-centre randomized two-armed parallel group trial of hospitalized patients with AMI ≥65 years, patients hospitalized between September 2008 and May 2010 in the Hospital of Augsburg, Germany, were randomly assigned to case management or usual care. The case-management intervention consisted of a nurse-based follow-up for three years including home visits and telephone calls. Study endpoints were time to first unplanned readmission or death, clinical parameters, functional status, depressive symptoms and malnutrition risk. Persons who assessed three-year outcomes and validated readmission data were blinded. The intention-to-treat approach was applied to the statistical analyses which included Cox Proportional Hazards models.Three hundred forty patients were allocated to receive case-management (n = 168) or usual care (n = 172). During three years, in the intervention group there were 80 first unplanned readmissions and 6 deaths, while the control group had 111first unplanned readmissions and 3 deaths. The intervention did not significantly affect time to first unplanned readmission or death (Hazard Ratio 0.89, 95% confidence interval (CI) 0.67-1.19; p = 0.439), blood pressure, cholesterol level, instrumental activities of daily life (IADL) (only for men), and depressive symptoms. However, patients in the intervention group had a significantly better functional status, as assessed by the HAQ Disability Index, IADL (only for women), and hand grip strength, and better SCREEN-II malnutrition risk scores than patients in the control group.A nurse-based management among elderly patients with AMI did not significantly affect time to unplanned readmissions or death during a three-year follow-up. However, the results indicate that functional status and malnutrition risk can be improved.Current Controlled Trials ISRCTN02893746.

Hypertension is a very common comorbidity and major risk factor for cardiovascular complications, especially in people with Type 2 Diabetes (T2D). Nevertheless, studies in the past have shown that blood pressure is often insufficiently controlled in medical practice. For the DIAB-CARE study, we used longitudinal data based on the German DIAB-CORE Consortium to assess whether health care regarding hypertension has improved during the last decade in our participants.Data of the three regional population-based studies CARLA (baseline 2002-2006 and follow-up 2007-2010), KORA (baseline 1999-2001 and follow-up 2006-2008) and SHIP (baseline 1997-2001 and follow-up 2002-2006) were pooled. Stratified by T2D status we analysed changes in frequencies, degrees of awareness, treatment and control. Linear mixed models were conducted to assess the influence of sex, age, study, and T2D status on changes of systolic blood pressure between the baseline and follow-up examinations (mean observation time 5.7 years). We included 4,683 participants aged 45 to 74 years with complete data and accounted for 1,256 participants who were lost to follow-up by inverse probability weighting.Mean systolic blood pressure decreased in all groups from baseline to follow-up (e.g. - 8.5 mmHg in those with incident T2D). Pulse pressure (PP) was markedly higher in persons with T2D than in persons without T2D (64.14 mmHg in prevalent T2D compared to 52.87 mmHg in non-T2D at baseline) and did not change much between the two examinations. Awareness, treatment and control increased considerably in all subgroups however, the percentage of those with insufficiently controlled hypertension remained high (at about 50% of those with hypertension) especially in prevalent T2D. Particularly elderly people with T2D often had both, high blood pressure ≥140/90 mmHg and a PP of ≥60 mmHg. Blood pressure in men had improved more than in women at follow-up, however, men still had higher mean SBP than women at follow-up.Blood pressure management has developed positively during past years in Germany. While hypertension prevalence, awareness and treatment were substantially higher in participants with T2D than in those without T2D at follow-up, hypertension control was achieved only in about half the number of people in each T2D group leaving much room for further improvement.

Objective. This study aims to examine the relationship of diabetes care processes and patient outcomes with an expanded set of indicators regarding patient-oriented care delivery, such as treatment satisfaction, the quality of patient-physician relationship, and a wider range of patient outcomes such as self-management, health behaviour, disease-related burden, and health-related quality of life (HRQL). Methods. The study population consisted of 486 participants with type 2 diabetes in two population-based follow-up surveys, conducted in 2003 to 2005 and 2006 to 2008 in Southern Germany. Data were self-reported and questionnaire-based, including the SF-12 for HRQL. Multiple regression models were used to identify associations between care processes and outcomes with adjustment for confounders. Results. Frequent medical examinations increased the likelihood of self-monitoring activities, such as foot care. A positive patient experienced relationship with their physician is associated with higher adherence to medical recommendations, such as medication intake, and the score of the SF-12 mental component. Participants with diabetes-related complications reported higher levels of medical examinations and multiprofessional care. Conclusions. Indicators of patient-oriented care should become an indispensable part of diabetes clinical practice guidelines with the aim of striving for more effective support of patients.

Cardiovascular disease is the leading cause of morbidity and mortality in the developed world. To reduce this burden of disease, a German sickness fund ('Siemens-Betriebskrankenkasse', SBK) initiated the prevention programme 'KardioPro' including primary (risk factor reduction) and secondary (screening) prevention and guideline-based treatment. The aim of this study was to assess the effectiveness of 'KardioPro' as it is implemented in the real world.The study is based on sickness fund routine data. The control group was selected from non-participants via propensity score matching. Study analysis was based on time-to-event analysis via Cox proportional hazards regression with the endpoint 'all-cause mortality, acute myocardial infarction (MI) and ischemic stroke (1)', 'all-cause mortality (2)' and 'non-fatal acute MI and ischemic stroke (3)'.A total of 26,202 insurants were included, 13,101 participants and 13,101 control subjects. 'KardioPro' enrollment was associated with risk reductions of 23.5% (95% confidence interval (CI) 13.0-32.7%) (1), 41.7% (95% CI 30.2-51.2%) (2) and 3.5% (hazard ratio 0.965, 95% CI 0.811-1.148) (3). This corresponds to an absolute risk reduction of 0.29% (1), 0.31% (2) and 0.03% (3) per year.The prevention programme initiated by a German statutory sickness fund appears to be effective with regard to all-cause mortality. The non-significant reduction in non-fatal events might result from a shift from fatal to non-fatal events.

BACKGROUND: Diabetes treatment may differ by region and patients' socioeconomic position. This may be particularly true for newer drugs. However, data are highly limited. METHODS: We examined pooled individual data of two population-based German studies, KORA F4 (Cooperative Health Research in the Region of Augsburg, south), and the HNR (Heinz Nixdorf Recall study, west) both carried out 2006 to 2008. To ascertain the association between region and educational level with anti-hyperglycemic medication we fitted poisson regression models with robust error variance for any and newer anti-hyperglycemic medication, adjusting for age, sex, diabetes duration, BMI, cardiovascular disease, lifestyle, and insurance status. RESULTS: The examined sample comprised 662 participants with self-reported type 2 diabetes (KORA F4: 83 women, 111 men; HNR: 183 women, 285 men). The probability to receive any anti-hyperglycemic drug as well as to be treated with newer anti-hyperglycemic drugs such as insulin analogues, thiazolidinediones, or glinides was significantly increased in southern compared to western Germany (prevalence ratio (PR); 95% CI: 1.12; 1.02-1.22, 1.52;1.10-2.11 respectively). Individuals with lower educational level tended to receive anti-hyperglycemic drugs more likely than their better educated counterparts (PR; 95% CI univariable: 1.10; 0.99-1.22; fully adjusted: 1.10; 0.98-1.23). In contrast, lower education was associated with a lower estimated probability to receive newer drugs among those with any anti-hyperglycemic drugs (PR low vs. high education: 0.66; 0.48-0.91; fully adjusted: 0.68; 0.47-0.996). CONCLUSIONS: We found regional and individual social disparities in overall and newer anti-hyperglycemic medication which were not explained by other confounders. Further research is needed.

OBJECTIVE: There is increasing evidence that prevention programmes for type 2 diabetes mellitus (T2DM) and obesity need to consider individual and regional risk factors. Our objective is to assess the independent association of area level deprivation with T2DM and obesity controlling for individual risk factors in a large study covering the whole of Germany. METHODS: We combined data from two consecutive waves of the national health interview survey 'GEDA' conducted by the Robert Koch Institute in 2009 and 2010. Data collection was based on computer-assisted telephone interviews. After exclusion of participants

Economic variables such as income, education, and occupation are known to affect mortality and morbidity, such as cardiovascular disease, and have also been shown to be partly heritable. However, very little is known about which genes influence economic variables, although these genes may have both a direct and an indirect effect on health. We report results from the first large-scale collaboration that studies the molecular genetic architecture of an economic variable-entrepreneurship-that was operationalized using self-employment, a widely-available proxy. Our results suggest that common SNPs when considered jointly explain about half of the narrow-sense heritability of self-employment estimated in twin data (σ(g)(2)/σ(P)(2) = 25%, h(2) = 55%). However, a meta-analysis of genome-wide association studies across sixteen studies comprising 50,627 participants did not identify genome-wide significant SNPs. 58 SNPs with p

BACKGROUND: Impulse oscillometry (IOS) is a non-demanding lung function test. Its diagnostic use may be particularly useful in patients of advanced age with physical or mental limitations unable to perform spirometry. Only few reference equations are available for Caucasians, none of them covering the old age. Here, we provide reference equations up to advanced age and compare them with currently available equations. METHODS: IOS was performed in a population-based sample of 1990 subjects, aged 45-91 years, from KORA cohorts (Augsburg, Germany). From those, 397 never-smoking, lung healthy subjects with normal spirometry were identified and sex-specific quantile regression models with age, height and body weight as predictors for respiratory system impedance, resistance, reactance, and other parameters of IOS applied. RESULTS: Women (n = 243) showed higher resistance values than men (n = 154), while reactance at low frequencies (up to 20 Hz) was lower (p

To identify genetic loci influencing central obesity and fat distribution, we performed a meta-analysis of 16 genome-wide association studies (GWAS, N = 38,580) informative for adult waist circumference (WC) and waist-hip ratio (WHR). We selected 26 SNPs for follow-up, for which the evidence of association with measures of central adiposity (WC and/or WHR) was strong and disproportionate to that for overall adiposity or height. Follow-up studies in a maximum of 70,689 individuals identified two loci strongly associated with measures of central adiposity; these map near TFAP2B (WC, P = 1.9x10(-11)) and MSRA (WC, P = 8.9x10(-9)). A third locus, near LYPLAL1, was associated with WHR in women only (P = 2.6x10(-8)). The variants near TFAP2B appear to influence central adiposity through an effect on overall obesity/fat-mass, whereas LYPLAL1 displays a strong female-only association with fat distribution. By focusing on anthropometric measures of central obesity and fat distribution, we have identified three loci implicated in the regulation of human adiposity.