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Background: Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative ("evidence and consensus based indication critera for total arthroplasty") developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality.Methods: The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients' decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%.Discussion: There is a high potential for transferring the intervention into routine practice if the evaluation is positive.Trial Registration: ClinicalTrials.gov: NCT04837053 . Registered on 08/04/2021. [ABSTRACT FROM AUTHOR]

Background: Palliative care in Germany is divided into general (GPC) and specialised palliative care (SPC). Although palliative care will become more important in the care sector in future, there is a large knowledge gab, especially with regard to GPC. The aim of this study was to identify and compare the burdens, resources, health and wellbeing of nurses working in GPC and SPC. Such information will be helpful for developing prevention programs in order to reduce burdens and to strengthen resources of nurses. Methods: In 2017, a nationwide cross-sectional survey was conducted. In total, 437 nurses in GPC and 1316 nurses in SPC completed a questionnaire containing parts of standardised instruments, which included parts of the Copenhagen Psychosocial Questionnaire (COPSOQ), the Patient Health Questionnaire (PHQ-2), the Resilience Scale (RS-13) Questionnaire, a single question about back pain from the health survey conducted by the Robert Koch Institute as well as self-developed questions. The differences in the variables between GPC and SPC nurses were compared. Results: SPC nurses reported higher emotional demands as well as higher burdens due to nursing care and the care of relatives while GPC nurses stated higher quantitative demands, i.e. higher workload. SPC nurses more often reported organisational and social resources that were helpful in dealing with the demands of their work. Regarding health, GPC nurses stated a poorer health status and reported chronic back pain as well as a major depressive disorder more frequently than SPC nurses. Furthermore, GPC nurses reported a higher intention to leave the profession compared to SPC nurses. Conclusions: The findings of the present study indicate that SPC could be reviewed as the best practice example for nursing care in Germany. The results may be used for developing target group specific prevention programs for improving health and wellbeing of nurses taking the differences between GPC and SPC into account. Finally, interventional and longitudinal studies should be conducted in future to determine causality in the relationship of burdens, resources, health and wellbeing. [ABSTRACT FROM AUTHOR]

Background: The rapid increase in the use of home mechanical ventilation (HMV) for people with chronic respiratory failure poses extreme challenges for the healthcare system. People on HMV have complex care needs and require support from an interprofessional team. In Germany, HMV is criticised for inadequate quality standards, particularly in outpatient intensive care practice. The objective of this study was to describe the quality of care for people on outpatient HMV in Germany, Bavaria and provide recommendations for improvement from the perspective of healthcare professionals (HCPs).Methods: Semi-structured qualitative telephone interviews with HCPs (i.e., nurses, equipment providers, therapists, and physicians) were analysed using the framework method. The quality framework of Health Improvement Scotland (HIS), which aims to improve the quality of person-centred care, was used to build a deductive analysis matrix. The framework includes the three key areas: (1) Outcomes and impact, (2) Service delivery, and (3) Vision and leadership. The domains (meta-codes) and quality indicators (sub-codes) of the quality framework were used for deductive coding.Results: Overall, 87 HCPs (51 female, mean age of 44.3 years, mean professional experience in HMV of 9.4 years) were interviewed (mean duration of 31 min). There was a complex interaction between the existing health care system (Outcomes and impact, 955 meaning units), the delivery of outpatient intensive care (Service delivery, 939 meaning units), and improvement-focused leadership (Vision and leadership, 70 meaning units) that influenced the quality of care for people on HMV. The main barriers were an acceleration in transition management, a neglect of weaning potential, a shortage of qualified professionals and missing quality criteria. The central recommendations for promoting person-centred care were training and supervision of staff and an inspiring leadership. An integrated care structure supporting medical home visits and outpatient rehabilitation should be developed.Conclusion: This study describes a heterogeneous and partly deficient care situation for people on HMV, but demonstrates that high quality care is possible if person-centred care is successfully implemented in all areas of service provision. The recommendations of this study could inform the development of a person-centred integrated care structure for people on HMV. [ABSTRACT FROM AUTHOR]

Background: The workplace has been identified as a priority setting for health promotion. There are potential advantages of systematically integrating Occupational Health Management (OHM) and Corporate Social Responsibility (CSR). However, OHM and CSR are usually overseen by different management branches with different sets of values, and there is a lack of empirical research regarding interfaces between OHM and CSR. Germany offers a particularly useful setting due to legislation requiring health to be promoted in the workplace. This study aims to examine key stakeholders' views and experiences regarding interfaces between OHM and CSR in German companies.Methods: Individual semi-structured qualitative interviews were conducted with a sample of 77 German stakeholders from three different groups: experts in occupational health and corporate social responsibility from various companies (n = 35), business partners (n = 19), and various non-business partners (n = 23). Transcripts were analysed using qualitative content analysis.Results: Participants identified several areas in which OHM and CSR are already interacting at strategic, structural and cultural levels, but also highlighted several barriers that undermine a more meaningful interaction. Participants reported difficulties in articulating the underlying ethical values relevant to both OHM and CSR at the strategic level. Several structural barriers were also highlighted, including a lack of resources (both financial and knowledge), and OHM and CSR departments not being fully developed or undertaken at entirely different operational levels. Finally, the missing practical implementation of corporate philosophy was identified as a critical cultural barrier to interfaces between OHM and CSR, with existing guidelines and companies' philosophies that already connect OHM and CSR not being embraced by employees and managers.Conclusions: There is already significant overlap in the focus of OHM and CSR, at the structural, strategic and cultural levels in many German companies. The potential is there, both in theory and practice, for the systematic combination of OHM and CSR. The insights from this study will be useful to ensure that closer integration between both management branches is set up in a socially sustainable and ethical manner. [ABSTRACT FROM AUTHOR]

Background: Patients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.Methods: In total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2.Discussion: This trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.Trial Registration: ClinicalTrials.gov NCT04240717 . Registered on 27 January 2020. [ABSTRACT FROM AUTHOR]

Objective: To participate in shared decision making (SDM), patients need to understand their options and develop trust in their own decision‐making abilities. Two experiments investigated the potential of decision aids (DAs) in preparing patients for SDM by raising awareness of preference‐sensitivity (Study 1) and showing possible personal motives for decision making (Study 2) in addition to providing information about the treatment options. Methods: Participants (Study 1: N = 117; Study 2: N = 217) were put into two scenarios (Study 1: cruciate ligament rupture; Study 2: contraception), watched a consultation video and were randomized into one of three groups where they received additional information in the form of (a) narrative patient testimonials; (b) non‐narrative decision strategies; and (c) an unrelated text (control group). Results: Participants who viewed the patient testimonials or decision strategies felt better prepared for a decision (Study 1: P <.001, ηP2 = 0.43; Study 2: P <.001, ηP2 = 0.57) and evaluated the decision‐making process more positively (Study 2: P <.001, ηP2 = 0.13) than participants in the control condition. Decision certainty (Study 1: P <.001, ηP2 = 0.05) and satisfaction (Study 1: P <.001, ηP2 = 0.11; Study 2: P =.003, d = 0.29) were higher across all conditions after watching the consultation video, and certainty and satisfaction were lower in the control condition (Study 2: P <.001, ηP2 = 0.05). Discussion: Decision aids that explain preference‐sensitivity and personal motives can be beneficial for improving people's feelings of being prepared and their perception of the decision‐making process. To reach decision certainty and satisfaction, being well informed of one's options is particularly relevant. We discuss the implications of our findings for future research and the design of DAs. [ABSTRACT FROM AUTHOR]

Background: The objective of this work was to analyse the prevalence trends of multimorbidity among European community-dwelling adults.Methods: A temporal series study based on waves 1, 2, 4, 5, 6 and 7 of the Survey of Health, Ageing and Retirement in Europe (SHARE) was conducted, and community-dwelling participants aged 50+ (n = 274,614) from 15 European countries were selected for the period 2004-2017. Prevalence, adjusted by age, Average Annual Percentage Change (APC) and 95% confidence interval (95% CI) were all calculated. Trend analyses were realised by period, age groups and groups of diseases.Results: The results showed a large variability in the prevalence of multimorbidity in adults aged 50 and over among European countries. Increase in the prevalence of multimorbidity in the countries of central Europe (Austria, Belgium, Czech Republic, France, Germany and Switzerland) and Spain in both sexes, and in the Netherlands among men. Stability was observed in northern and eastern European countries. Musculoskeletal and neurodegenerative groups showed more significant changes in the trend analyses.Conclusions: This information can be useful for policy makers when planning health promotion and prevention policies addressing modifiable risk factors in health. [ABSTRACT FROM AUTHOR]

Background: More than half of the unaccompanied young refugees (UYRs) resettled in Europe report elevated levels of posttraumatic stress symptoms (PTSS) and comorbid symptoms. Earlier studies have highlighted the effectiveness of the trauma-focused preventive group intervention "Mein Weg" (English "My Way"), and the feasibility of trauma-focused cognitive behavioral therapy (TF-CBT) for UYRs. Both interventions are deemed to be empirically supported treatments (ESTs). However, UYRs seldom receive ESTs or, in fact, any treatment at all. In view of the high need and the limited treatment resources available, a stepped-care approach is indicated but has not been evaluated so far. The purpose of this trial is to compare the stepped-care approach BETTER CARE with usual care enhanced with screening and indication (usual care+).Methods: In a cluster randomized controlled trial involving N = 540 UYRs living in up to N = 54 child and youth welfare service (CYWS) facilities, BETTER CARE will be compared with usual care+. We will randomize clusters comprising a CYWS facility with at least one eligible psychotherapist. BETTER CARE consists of step (1) screening and indication and either step (2) preventive trauma-focused group intervention "Mein Weg" delivered by trained CYWS staff or step (3) TF-CBT delivered by trained community therapists and supported by trained translators if necessary. Participants will be assessed 6 and 12 months after randomization. The primary outcome is the severity of PTSS after 12 months. Secondary outcomes are depressive and anxiety symptoms, quality of life, and proxy reported PTSS. Furthermore, drug use, health costs, benefits, and long-term effects on integration/acculturation will be assessed.Discussion: The trial will directly integrate a stepped-care approach into existing structures of the German child welfare and (mental) health system. It could, therefore, serve as a blueprint for how to implement ESTs for UYRs. If successful, screening, prevention, and intervention will be sustainably implemented in CYWS in southern Germany.Trial Registration: German Clinical Trials Register DRKS00017453 . Registered on 11 December 2019. [ABSTRACT FROM AUTHOR]

Background Since the first cases of the novel coronavirus disease SARS-CoV-2 were reported in December 2019 in China, the virus has spread in most countries. The aim of the present study was to assess initial data on the mental health burden of the German public during the COVID-19 pandemic. Methods A cross-sectional study was conducted in Germany and collected complete datasets from 15 704 German residents aged 18 years and over. Besides demographics, generalized anxiety (GAD-7), depression (PHQ-2) and psychological distress (DT) were assessed. Furthermore, COVID-19-related fear, trust in governmental actions to face COVID-19 and the subjective level of information regarding COVID-19 were covered. Results Significantly increased symptoms were highly prevalent in all dimensions: generalized anxiety (44.9%), depression (14.3%), psychological distress (65.2%) and COVID-19-related fear (59%). Females and younger people reported higher mental burden. Trust in governmental actions to face COVID-19 and the subjective level of information regarding COVID-19 are negatively associated with mental health burden. However, the subjective level of information regarding COVID-19 is positively associated with increased COVID-19-related fear. Conclusions The provision of appropriate psychological interventions for those in need and the provision of transparency and comprehensible information are crucial during the current pandemic. [ABSTRACT FROM AUTHOR]

Background: Sleep disturbances are common in people with dementia. In nursing homes, this is frequently associated with residents' challenging behavior and potentially with nurses' burden. This study examined nurses' burden associated with nursing home residents' sleep disturbances. Methods: A multicenter cross-sectional study was conducted. Nurses' burden associated with residents' sleep disturbances was assessed using the Sleep Disorder Inventory (SDI). Additionally, the proportion of nurses' total burden associated with sleep disturbances of residents with dementia was assessed. A linear mixed regression model was used to investigate the association with nurses', residents' and institutional characteristics. Results: One hundred eleven nurses from 38 nursing homes were included. 78.4% stated to be regularly confronted with residents' sleep disturbances during nightshifts, causing distress. The mean proportion of nurses' total burden caused by residents' sleep disturbances was 23.1 % (SD 18.1). None of the investigated characteristics were significantly associated with nurses' total burden. Conclusions: Nurses report burden associated with sleep disturbances as common problem. There is a need to develop effective interventions for sleep problems and to train nurses how to deal with residents' sleep disturbances. [ABSTRACT FROM AUTHOR]

Background: Autoimmune encephalitis is a new spectrum of autoimmune disorders of the central nervous system (CNS), which are characterized by pathogenic autoantibodies against neuronal surface antigens. Clinical presentations range from acute to subacute encephalopathy with neurological and psychiatric symptoms, and life-threatening autonomic dysfunction in severe cases. There exist no approved therapies nor is data available from controlled clinical trials. Patients are usually treated with diverse combinations of immunotherapy. However, effect of immunotherapy on antibody-producing cells and thus on levels of pathogenic autoantibodies is insufficient. Therefore, therapeutic response is sometimes prolonged with necessity of long-time intensive care treatment and also irreversible deficits occur in severe cases. This trial will investigate the efficacy and safety of bortezomib, a proteasome inhibitor known to selectively deplete plasma cells, in patients with severe autoimmune encephalitis who have been treated with rituximab with insufficient response.Methods: Generate-Boost is an investigator-initiated, multicenter, double-blinded, randomized controlled phase II trial which will be conducted in specialized neurological hospitals within the GENERATE (GErman NEtwork for Research on AuToimmune Encephalitis) network in Germany. Adult patients with severe autoimmune encephalitis (modified Rankin scale, mRS ≥ 3), autoantibodies against neuronal surface antigens, and pretreatment with rituximab are eligible for study participation. Fifty patients will be randomized 1:1 and undergo up to 3 cycles (each 21 days with 4 s. c. applications) of bortezomib or placebo. All patients will receive concomitant medication with dexamethasone, acyclovir and co-trimoxazole. The primary efficacy endpoint is the mRS score 17 weeks after first treatment application. Secondary endpoints are neurocognitive function, antibody titers, markers of neuronal cell damage, length of ICU/hospital stay, and mRS and Glasgow coma scale scores throughout the trial up to week 17. General and bortezomib-specific adverse events are monitored continuously.Discussion: The expected outcome of the study is to obtain first reliable data on a hypothesis-driven therapeutic option in severe and difficult-to-treat autoimmune encephalitis. If treatment with bortezomib is beneficial in these cases, this will be the basis for implementation in the current guidelines.Trial Registration: Clinicaltrials.gov , NCT03993262 . Registered June 20, 2019; German Clinical Trials Register, DRKS00017497. [ABSTRACT FROM AUTHOR]

Background: Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women's personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful.Methods/design: A randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decision-making and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study.Discussion: The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. TRIAL REGISTRATION {2A}: DRKS-ID: DRKS00015527. Registered 30 October 2019. [ABSTRACT FROM AUTHOR]

Background: Estimating infectious disease parameters such as the serial interval (time between symptom onset in primary and secondary cases) and reproductive number (average number of secondary cases produced by a primary case) are important in understanding infectious disease dynamics. Many estimation methods require linking cases by direct transmission, a difficult task for most diseases.Methods: Using a subset of cases with detailed genetic and/or contact investigation data to develop a training set of probable transmission events, we build a model to estimate the relative transmission probability for all case-pairs from demographic, spatial and clinical data. Our method is based on naive Bayes, a machine learning classification algorithm which uses the observed frequencies in the training dataset to estimate the probability that a pair is linked given a set of covariates.Results: In simulations, we find that the probabilities estimated using genetic distance between cases to define training transmission events are able to distinguish between truly linked and unlinked pairs with high accuracy (area under the receiver operating curve value of 95%). Additionally, only a subset of the cases, 10-50% depending on sample size, need to have detailed genetic data for our method to perform well. We show how these probabilities can be used to estimate the average effective reproductive number and apply our method to a tuberculosis outbreak in Hamburg, Germany.Conclusions: Our method is a novel way to infer transmission dynamics in any dataset when only a subset of cases has rich contact investigation and/or genetic data. [ABSTRACT FROM AUTHOR]

Objective: To examine the effectiveness of single and repeat sonographic cervical-length (CL) measurement in predicting preterm delivery in symptomatic women with a twin pregnancy.Methods: This was a retrospective study of women with a twin gestation who presented with painful and regular uterine contractions at 24 + 0 to 33 + 6 weeks' gestation at the perinatal unit of the University Hospital of Tübingen, Tübingen, Germany between 2012 and 2018. CL was measured on transvaginal ultrasound at the time of admission and a few days later after cessation of contractions. Treatment included administration of tocolytics (usually oral nifedipine), for no more than 48 h, and administration of steroids if CL was ≤ 25 mm. Patients were clustered into five groups according to the CL measurement obtained at first assessment: < 10.0 mm; between 10.0 and 14.9 mm; between 15.0 and 19.9 mm; between 20.0 and 24.9 mm; and ≥ 25.0 mm. For each group, we calculated the test performance of CL measurement for prediction of preterm delivery within the subsequent 7 days and before 34 weeks' gestation. Regression analysis was used to evaluate the test performance of the second CL measurement for predicting preterm delivery within 7 days after the second assessment.Results: The study population consisted of 257 twin pregnancies, of which 80.2% were dichorionic diamniotic. Median maternal and gestational ages at the time of admission were 32.0 years and 29.9 weeks' gestation, respectively. Preterm birth within 7 days of admission occurred in 23 (8.9%) pregnancies, and 82 (31.9%) patients delivered prior to 34 weeks' gestation. Median CL for the entire study population was 17.0 mm. Delivery within 7 days after the first assessment occurred in 29.0%, 10.6%, 4.2%, 6.3% and 0% of women with CL < 10.0 mm, 10.0-14.9 mm, 15.0-19.9 mm, 20.0-24.9 mm and ≥ 25.0 mm, respectively. There was a weak, but significant, association between the CL measurement at the time of admission and the time interval between admission and delivery (interval = 27.9 + 0.58 × CL; P = 0.003, r = 0.184). CL was measured again after a median time interval of 3 (interquartile range (IQR), 2-5) days in 248 cases. Median second CL measurement was 17.0 (IQR, 11.5-22.0) mm. Delivery occurred within the subsequent 7 days after the second measurement in 25/248 (10.1%) cases. Binary regression analysis indicated that the first (odds ratio (OR), 0.895; P = 0.003) and second (OR, 0.908; P = 0.002) CL measurements, but not the difference between the two measurements (OR, 0.961; P = 0.361), were associated significantly with delivery within 7 days after the second measurement. Receiver-operating-characteristics (ROC)-curve analysis for the prediction of delivery within 7 days after the second assessment did not show a significant difference between the predictive performance of the first (area under ROC curve (AUC), 0.676 (95% CI, 0.559-0.793)) and the second (AUC, 0.661 (95% CI, 0.531-0.790)) measurement.Conclusion: Sonographic measurement of CL can be helpful in predicting preterm delivery within 7 days of presentation in symptomatic women with a twin gestation; however, the test performance is relatively weak. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Background: The objective of the IMPROVE study was patients' preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced HR-positive/HER2-negative breast cancer.Methods: In this randomized, cross-over phase IV study, 77 patients were recruited in 26 sites in Germany. Patients were randomized 1:1 to receive either capecitabine plus bevacizumab (Cap+Bev) as first-line therapy followed by cross-over to everolimus plus exemestane (Eve+Exe) as second-line therapy (Arm A) or the reverse sequence (Arm B). The primary endpoint was patients' preference for either regimen, assessed by the Patient Preference Questionnaire 12 weeks after cross-over. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL).Results: 61.5% of patients preferred Cap+Bev (p = 0.1653), whereas 15.4% preferred Eve+Exe and 23.1% were indecisive. Physicians showed a similar tendency towards Cap+Bev (58.1%) as the preferred regimen versus Eve+Exe (32.3%). Median first-line PFS was longer for Cap+Bev than for Eve+Exe (11.1 months versus 3.5 months). Median second-line PFS was similar between Cap+Bev and Eve+Exe (3.6 months versus 3.7 months). Median OS was comparable between Arm A (28.8 months) and Arm B (24.7 months). 73.0% and 52.6% (first-/second-line, Cap+Bev) and 54.1% and 52.9% (first-/second-line, Eve+Exe) of patients experienced grade 3/4 TEAEs. No treatment-related deaths occurred. QoL and treatment satisfaction were not significantly different between arms or treatment lines.Conclusions: Patients tended to favor Cap+Bev over Eve+Exe, which was in line with physicians' preference. Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported.Trial Registration: EudraCT No: 2013-005329-22. Registered on 19 August 20. [ABSTRACT FROM AUTHOR]

Background: The implementation of clearly structured dementia-specific case conferences could be an important tool to enable nursing staff to properly analyse and manage challenging behaviour in nursing home residents with dementia. A process evaluation of the responses of nursing homes to the implementation of WELCOME-IdA (Wittener model of case conferences for people with dementia – the Innovative dementia-oriented Assessment tool) was carried out to gain insight into which key elements of the intervention were adopted by the nursing homes and which elements were adapted. Methods: This study was part of a larger process evaluation using a qualitative design. Thirty-four semi-structured telephone interviews and 15 focus group interviews were conducted in four nursing homes. The interviews were analysed using deductive content analysis, although inductive categories have been developed. Results: Nursing home staff adopted the roles of moderator, case reporter, keeper of the minutes and reflection partner in WELCOME-IdA, but the selection of the staff members who filled these roles differed across nursing homes. The recommended group size of 5–8 participants per case conference was sometimes adopted. The key element of having core nursing teams who participated continuously in all case conferences was not adopted at all. Instead, there was a high level of rotation among staff members. The pre-defined process structure of WELCOME-IdA was adapted in such a way that the assessment of the residents' behaviour and the selection of the relevant domain for the behaviour analysis were conducted in advance of the case conference. The evaluation of the interventions was also organized differently. Conclusion: The scope of the response implies that WELCOME-IdA requires further adaptation to the requirements of nursing processes in nursing homes. The results provide important information on the selection of role keepers and offer insights into a) how knowledge of the structured training was circulated and transformed into self-organized case conferences and b) how knowledge was circulated throughout the entire processing of one case. Thus, these results can be used to optimize intervention and implementation. Overall, the intervention should allow more possibilities for tailored adaptation than it currently does. [ABSTRACT FROM AUTHOR]

Background: Technical innovation to assess patient-reported outcomes (PROs) facilitates their implementation in clinical practice. In particular, mobile applications (apps) allow PROs to be assessed outside of the clinical setting. A patient's health status can be remotely monitored and evaluated after discharge, and their recovery process tracked. This is of particular interest for patients after knee arthroplasty, as the recovery phase after surgery usually takes place in an outpatient setting and requires a high level of patient engagement. Providing results of PRO assessments to patients in the form of a feedback report could increase patient engagement and may improve communication between health care professionals and patients. The aim of the study is to develop a PRO feedback report for mobile devices that is comprehensible and provides valuable information for patients after knee arthroplasty. Results: In an iterative development process, our expert group developed two preliminary feedback reports (a text-based version and a graphical display) based on previous research results and practical experience. In a second step, we discussed these reports with orthopedic patients (n = 8) in terms of comprehensibility and value using semi-structured interviews and cognitive debriefing methods. Participants assessed the reports as informative, but had some difficulties in fully comprehending all of the information provided. Based on the feedback from patients, we modified both versions and reduced complexity to increase comprehensibility. Conclusions: A PRO feedback report for patients for mobile app use has to take account of the heterogeneous user group, particularly demographics such as age and experience with mobile devices. Information should be presented in a simple way to be comprehensible and of value to patients. Technological advancements allow a simple default report to be set, something which enables patients interested in additional information to make customizations. [ABSTRACT FROM AUTHOR]

Background: An ageing and a shrinking labour force implies that the prevention of a premature exit from work due to poor health will become more relevant in the future. Medical rehabilitation is a health service that aims at active participation in working life. The provision of this service will be relevant for an increasing part of the ageing labour force, namely, employees with a migrant background and their different subgroups. Thus, this study examines whether first- and second-generation employees with migrant background differ from non-migrants in their utilisation of rehabilitation services and whether within the subsample of migrant employees, those persons with foreign nationality differ from those with German nationality.Methods: Socially insured employees born in 1959 or 1965 were surveyed nationwide in 2011 as part of the lidA cohort study (n=6303). Survey data of the first study wave were used to identify the dependent variable of the utilisation of rehabilitation (in- and outpatient), the independent variable of migrant status and the covariates of sociodemographic, work- and non-work-related factors. Applying bivariate statistics with tests of independence and block-wise logistic regressions, differences between the groups were investigated. Additionally, average marginal effects were computed to directly compare the adjusted models.Results: The study showed that first-generation migrants had a significantly lower likelihood of utilising outpatient rehabilitation than non-migrants (fully adj. OR 0.42, 95% CI 0.22-0.82) and that average marginal effects indicated higher differences in the full model than in the null model. No significant differences were found between the first- or second-generation migrants and non-migrants when comparing the utilisation of inpatient rehabilitation or any rehabilitation or when analysing German and foreign employees with migrant background (n=1148).Conclusions: Significant differences in the utilisation of outpatient rehabilitation between first-generation migrants and non-migrants were found, which could not be explained by sociodemographic, work- and non-work-related factors. Thus, further factors might play a role. The second-generation migrants resemble the non-migrants rather than their parent generation (first-generation migrants). This detailed investigation shows the heterogeneity in the utilisation of health services such as medical rehabilitation, which is why service sensitive to diversity should be considered. [ABSTRACT FROM AUTHOR]

In research into higher education, the evaluation of completion and dropout rates has generated a steady stream of interest for decades. While most studies only calculate quotes using student and graduate numbers for both phenomena, we propose to additionally consider the budget available to universities. We transfer the idea of the excellence shift indicator [] from the research to the teaching area, in particular to the completion rate of educational entities. The graduation shift shows the institutions’ ability to produce graduates as measured against their basic academic teaching efficiency. It is an important advantage of the graduation shift that it avoids the well-known heterogeneity problem in efficiency measurements. Our study is based on German universities of applied science. Given their politically determined focus on education, this dataset is well-suited for introducing and evaluating the graduation shift. Using a comprehensive dataset covering the years 2008 to 2013, we show that the graduation shift produces results, which correlate closely with the results of the well-known graduation rate and standard Data Envelopment Analysis (DEA). Compared to the graduation rate, the graduation shift is preferable because it allows to take the budget of institutions into account. Compared to the DEA, the computation of the graduation shift is easy, the results are robust, and non-economists can understand them results. Thus, we recommend the graduation shift as an alternative method of efficiency measurement in the teaching area. [ABSTRACT FROM AUTHOR]

Background: Physician migration has been gaining attention worldwide. In Germany, physician migration became a topic of interest in the context of the discussion about a shortage of physicians, for which one contributing factor may be physicians leaving the country. However, there is a lack of literature on "push" factors causing German physicians to leave. The present study seeks to provide current data in an effort to promote the identification of "push" factors motivating German physicians to emigrate.Methods: In a cross-sectional survey, all physicians ≤40 years of age registered with the State Chamber of Physicians of Saxony, Germany (n = 5956) were sent a paper-pencil questionnaire examining socio-demographics, job satisfaction, the wish to emigrate, and the likelihood of moving abroad in the near future. Variables associated with the wish to emigrate were assessed with multivariate logistic regression models.Results: Approximately 30% of participants wished to emigrate. The favourite destination countries were Switzerland, Scandinavian countries, and Australia or New Zealand. Of participants wishing to emigrate, approximately 52% thought it likely to emigrate for a limited, and 15% for an unlimited period of time. Participants with the wish to emigrate were significantly less satisfied with their job situation as compared to physicians without the wish to emigrate, the one exception being their "relationship with patients". The three aspects with the highest difference in satisfaction were the overall work situation, followed by work load, and time for family, friends, and leisure activities. Being a woman, being in a relationship, and having children were associated with a lower chance for wishing to emigrate. Higher satisfaction with the factors "work load", "patient care", and "structural aspects" was also associated with a lower chance for wishing to emigrate.Conclusions: Emigration seems to be a viable option for at least a subset of physicians. Preventive measures should address modifiable determinants associated with an increased chance for wishing to emigrate, such as job satisfaction. Especially satisfaction with the factor "work load" seems to play a crucial role as a "push" factor for physician emigration. [ABSTRACT FROM AUTHOR]

Background: The year 2016 has marked the highest number of displaced people worldwide on record. A large number of these refugees are women, yet little is known about their specific situation and the hurdles they have to face during their journey. Herein, we investigated whether sociodemographic characteristics and traumatic experiences in the home country and during the flight affected the quality of life of refugee women arriving in Germany in 2015-2016.Methods: Six hundred sixty-three women from six countries (Afghanistan, Syria, Iran, Iraq, Somalia, and Eritrea) living in shared reception facilities in five distinct German regions were interviewed by native speakers using a structured questionnaire. Sociodemographic data and information about reasons for fleeing, traumatic experiences, symptoms, quality of life, and expectations towards their future were elicited. All information was stored in a central database in Berlin. Descriptive analyses, correlations, and multivariate analyses were performed.Results: The most frequent reasons cited for fleeing were war, terror, and threat to one's life or the life of a family member. Eighty-seven percent of women resorted to smugglers to make the journey to Europe, and this significantly correlated to residence in a war zone (odds ratio (OR) = 2.5, 95% confidence interval (CI) = 1.4-4.6, p = 0.003) and homelessness prior to fleeing (OR = 2.1, 95% CI = 1-4.3, p = 0.04). Overall the described quality of life by the women was moderate (overall mean = 3.23, range of 1-5) and slightly worse than that of European populations (overall mean = 3.68, p < 0.0001). The main reasons correlating with lower quality of life were older age, having had a near-death experience, having been attacked by a family member, and absence of health care in case of illness.Conclusions: Refugee women experience multiple traumatic experiences before and/or during their journey, some of which are gender-specific. These experiences affect the quality of life in their current country of residence and might impact their integration. We encourage the early investigation of these traumatic experiences to rapidly identify women at higher risk and to improve health care for somatic and mental illness. [ABSTRACT FROM AUTHOR]

Background: Offshore work has been described as demanding and stressful. Despite this, evidence regarding the occupational strain, health, and coping behaviors of workers in the growing offshore wind industry in Germany is still limited. The purpose of our study was to explore offshore wind employees' perceptions of occupational strain and health, and to investigate their strategies for dealing with the demands of offshore work.Methods: We conducted 21 semi-structured telephone interviews with employees in the German offshore wind industry. The interviews were transcribed and analyzed in a deductive-inductive approach following Mayring's qualitative content analysis.Results: Workers generally reported good mental and physical health. However, they also stated perceptions of stress at work, fatigue, difficulties detaching from work, and sleeping problems, all to varying extents. In addition, physical health impairment in relation to offshore work, e.g. musculoskeletal and gastrointestinal complaints, was documented. Employees described different strategies for coping with their job demands. The strategies comprised of both problem and emotion-focused approaches, and were classified as either work-related, health-related, or related to seeking social support.Conclusions: Our study is the first to investigate the occupational strain, health, and coping of workers in the expanding German offshore wind industry. The results offer new insights that can be utilized for future research in this field. In terms of practical implications, the findings suggest that measures should be carried out aimed at reducing occupational strain and health impairment among offshore wind workers. In addition, interventions should be initiated that foster offshore wind workers' health and empower them to further expand on effective coping strategies at their workplace. [ABSTRACT FROM AUTHOR]

Background: Although polypharmacy can cause adverse health outcomes, patients often know little about their medication. A regularly conducted medication review (MR) can help provide an overview of a patient's medication, and benefit patients by enhancing their knowledge of their drugs. As little is known about patient attitudes towards MRs in primary care, the objective of this study was to gain insight into patient-perceived barriers and facilitators to the implementation of an MR. Methods: We conducted a qualitative study with a convenience sample of 31 patients (age ≥ 60 years, ≥3 chronic diseases, taking ≥5 drugs/d); in Hesse, Germany, in February 2016. We conducted two focus groups and, in order to ensure the participation of elderly patients with reduced mobility, 16 telephone interviews. Both relied on a semi-structured interview guide dealing with the following subjects: patients' experience of polypharmacy, general design of MRs, potential barriers and facilitators to implementation etc. Interviews were audio-recorded, transcribed verbatim, and analysed by two researchers using thematic analysis. Results: Patients' average age was 74 years (range 62--88 years). We identified barriers and facilitators for four main topics regarding the implementation of MRs in primary care: patient participation, GP-led MRs, pharmacist-led MRs, and the involvement of healthcare assistants in MRs. Barriers to patient participation concerned patient autonomy, while facilitators involved patient awareness of medication-related problems. Barriers to GP-led MRs concerned GP'slackof resources while facilitators related to the trusting relationship between patient and GP. Pharmacist-led MRs might be hindered by a lack of patients' confidence in pharmacists' expertise, but facilitated by pharmacies' digital records of the patients' medications. Regarding the involvement of healthcare assistants in MRs, a potential barrier was patients' uncertainty regarding the extent of their training. Patients could, however, imagine GPs delegating some aspects of MRs to them. Conclusions: Our study suggests that patients regard MRs as beneficial and expect indications for their medicines to be checked, and possible interactions to be identified. To foster the implementation of MRs in primary care, it is important to consider barriers and facilitators to the four identified topics. [ABSTRACT FROM AUTHOR]

Background: Patients with chronic back pain show an increased use of health-care services leading to high direct costs. Multidisciplinary rehabilitation reduces pain intensity, depression, disability and work inability. The study aims to investigate whether health-care utilization in patients with chronic back pain is lower after rehabilitation than before rehabilitation and if, in addition to sociodemographic, medical and psychological characteristics, changes in these characteristics immediately after rehabilitation can predict health-care utilization.Methods: N = 688 patients with chronic back pain were asked about their overall health-care services use and the use of general practitioners, specialists, physiotherapy, psychotherapy, complementary therapist, massages, and admission to hospital both 6 months before and 6 months after rehabilitation. In addition, various sociodemographic, medical and psychological variables were assessed. To measure changes due to rehabilitation, differences in pain intensity, disability, impairment and coping, quality of life, and days on sick leave before and after rehabilitation were calculated. Dependent t-tests and hierarchical regression analyses were used to analyse the data.Results: Health-care utilization 6 months after rehabilitation was, except for physiotherapy and psychotherapy, significantly lower than before. The effect sizes were rather small (Cohens'd =. 01-.34). After rehabilitation between 15.2% and 39.9% of the variance of health-care utilization could be explained. The baseline values of health-care utilization explained between 3.2% and 15.9% of the incremental variances. The changes in psychological impairment and coping as well as in sick leave after rehabilitation could explain between 0.8% and 2.9% of the variance of health-care utilization after rehabilitation. Its influence was significant for the general use of health-care services, general practitioners and specialists.Conclusions: The results indicate that use of health-care services after rehabilitation in the present study is slightly lower than before, which has an impact on direct costs due to chronic back pain in Germany. The predictors show the importance in terms of health-care utilization of improving work ability and psychological impairment. [ABSTRACT FROM AUTHOR]

Background: In many countries health policy encourages patients to choose their hospital, preferably by considering information of performance reports. Previous studies on hospital choice mainly have focused on patients undergoing elective surgery. This study examined a representative sample of hospital inpatients across disciplines and treatment interventions in Germany. Its research questions were: How many patients decide where to go for hospital treatment? How much time do patients have before admission? Which sources of information do they use, and which criteria are relevant to their decision?Methods: Cross-sectional observational study covering 1925 inpatients of 46 departments at 17 hospitals in 2012. The stratified survey comprised 11 medical disciplines (internal medicine, gynaecology, obstetrics, paediatrics, psychiatry, orthopaedics, neurology, urology, ENT and geriatrics) on 3 hospital care levels representing 91.9% of all hospital admissions to inpatient care in Germany in 2012. The statistical analysis calculated the frequency distributions and 95% confidence intervals of characteristics related to the hospital choice.Results: 63.0% [60.9-65.2] of patients in Germany chose the hospital themselves, but only 21.1% [19.3-22.9] had more than one week to decide prior to admission. Major sources of information were personal knowledge of hospitals, relatives, outpatient health professionals and the Internet. Main criteria for the decision were personal experience with a hospital, recommendations from relatives and providers of outpatient services, a hospital's reputation and distance from home. Specific quality information as provided by performance reports were of secondary importance.Conclusions: A majority of patients in the German health system choose their hospital freely. Providers of outpatient health care can have an important "agent" function in the quality-oriented hospital choice especially for patients with little time prior to admission and those who do not decide themselves. Hospitals have an impact on patients' future hospital choices by the treatment experience they provide to patients. [ABSTRACT FROM AUTHOR]

Food and beverage marketing contributes to poor dietary choices among adults and children. As consumers spend more time on the Internet, food and beverage companies have increased their online marketing efforts. Studies have shown food companies' online promotions use a variety of marketing techniques to promote mostly energy-dense, nutrient-poor products, but no studies have compared the online marketing techniques and nutritional quality of products promoted on food companies' international websites. For this descriptive study, we developed a qualitative codebook to catalogue the marketing themes used on 18 international corporate websites associated with the world's three largest fast food and beverage companies (i.e. Coca-Cola, McDonald's, Kentucky Fried Chicken). Nutritional quality of foods featured on those websites was evaluated based on quantitative Nutrient Profile Index scores and food category (e.g. fried, fresh). Beverages were sorted into categories based on added sugar content. We report descriptive statistics to compare the marketing techniques and nutritional quality of products featured on the company websites for the food and beverage company websites in two high-income countries (HICs), Germany and the United States, two upper-middle-income countries (UMICs), China and Mexico, and two lower-middle-income countries (LMICs), India and the Philippines. Of the 406 screenshots captured from company websites, 67·8% depicted a food or beverage product. HICs' websites promoted diet food or beverage products/healthier alternatives (e.g. baked chicken sandwich) significantly more often on their pages (25%), compared to LMICs (14·5%). Coca-Cola featured diet products significantly more frequently on HIC websites compared to LMIC websites. Charities were featured more often on webpages in LMICs (15·4%) compared to UMICs (2·6%) and HICs (2·3%). This study demonstrates that companies showcase healthier products in wealthier countries and advertise their philanthropic activities in lower income countries, which is concerning given the negative effect of nutrition transition (double burden of overnutrition and undernutrition) on burden of non-communicable diseases and obesity in lower income countries. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to give an overview of family caregiver satisfaction within the home palliative care situation in North Rhine-Westphalia, Germany. Design: A cross-sectional study. Methods: An anonymous questionnaire, with seven validated scales, and comprising of 71 items, was used. The items investigated perceived needs and burdens of families within a home-based palliative care situation. The satisfaction of the family caregivers with the services delivered by palliative care teams was measured by the FAMCARE-2 Scale. Descriptive statistics and analysis of covariance (ANCOVA) were performed. Results: A convenience sample of 106 family members agreed to participate in the study. Overall, we found high satisfaction within our sample. There was high satisfaction with how the services respected the dignity of families, and how they provided comfort to patients. Satisfaction was lower with regard to information about patients. Conclusion: High or low satisfaction with palliative care, tells us little about the quality of services. The high satisfaction within this study could be interpreted as a sign that palliative care was important to families at the time of availability. Regular and continuous assessment can serve to inform the continuous quality of care provision for patients and their families. [ABSTRACT FROM AUTHOR]

Background: Patients from rural and urban regions should have equitable access to health care. In Germany, the physician-patient-ratio and the supply of medical services vary greatly between urban and rural areas. The aim of our study was to explore the regional variations of the perceived health care problems in ambulatory care from the perspective of affected professionals and laypersons i.e. general practitioners and their patients. Methods: We conducted 27 focus groups with general practitioners (n = 65) and patients (n = 145) from urban areas, environs and rural areas in northern Germany. Discussions were facilitated by two researchers using a semi-structured guideline. The transcripts were content analyzed using deductive and inductive categories. Results: General practitioners and patients reported problems due to demographic change and patient behaviour, through structural inequalities and the ambulatory reimbursement system as well as with specialist care and inpatient care. A high physician density, associated with high competition between general practitioners, a high fluctuation of patients and a low status of general practitioners were the main problems reported in urban areas. In contrast, participants from rural areas reported an insufficient physician density, a lack of young recruits in primary care and a resulting increased workload as problematic. All regions are concerned with subjectively inadequate general practitioners' budgets, insufficiently compensated consultations and problems in the cooperation with specialists and inpatient care institutions. Most problems were mentioned by GPs and patients alike, but some (e.g. high competition rates in urban regions and problems with inpatient care) were only mentioned by GPs. Conclusions: While many problems arise in urban regions as well as in rural regions, our results support the notion that there is an urgent need for action in rural areas. Possible measures include the support of telemedicine, delegation of medical services and reoccupation of vacant practices. The attractiveness of working in rural areas for general practitioners, specialists and clinicians must be increased by consolidating and expanding rural infrastructure (e.g. child care and cultural life). The above mentioned results also indicate that the ambulatory reimbursement system should be examined regarding the reported inequalities. Measures to further enhance the cooperation between general practitioners, specialists and inpatient care should be taken to solve supra-regionally reported problems. Problems showing regional variations indicate the need for measures to balance these variations between the regions. This is the first German study to analyze subjective views of the stakeholders concerned on regionally variating problems in ambulatory care. Further studies are needed to quantify the extent of the identified problems and differences. A corresponding survey is currently under way. [ABSTRACT FROM AUTHOR]

Background: Migrants in many European countries including Germany tend to utilize preventive measures less frequently than the majority population. Little is known about the dental health of migrants as well as about their oral health behaviour, particularly in the adult population. The aim of this study was to examine differences in the uptake of annual dental check-ups in adult migrants and non-migrants in Germany. Methods: We used data from the cross-sectional survey 'German Health Update 2010' conducted by the Robert Koch Institute (n = 22,050). Data from 21,741 German-speaking respondents with information on the use of dental check-ups was available, of which 3404 (15.7%) were migrants. Multiple logistic regression models were applied to adjust for demographic and socioeconomic confounders, including the place of residence as well as type of health insurance. Results: Migrants were generally younger, had a lower socioeconomic status and showed a lower utilization of dental check-ups. The unadjusted odds ratio (OR) for utilization was 0.67 (95%-CI = 0.61--0.73). After adjusting for demographic and socioeconomic confounders the chance only increased slightly (adjusted OR = 0.71; 95%-CI = 0.65--0.77). Conclusions: The analysis shows that migration status is associated with a reduced chance of attending dental checkups, independently of demographic and socioeconomic factors. The influence of other factors, such as type of health insurance and place of residence had also no influence on the association. Migrants are exposed to different barriers in the health care system, comprising the patient, provider and system level. Further studies need to examine the relevant barriers for the uptake of preventive dental services in order to devise appropriate migrant- sensitive measures of dental prevention. [ABSTRACT FROM AUTHOR]

Background The importance of patient participation and involvement is now widely acknowledged; in the past, few systematic health-care institution policies existed to establish sustainable co-operation. In 2004, in Germany, the initiative 'Self-Help Friendliness ( SHF) and Patient-Centeredness in Health Care' was launched to establish and implement quality criteria related to collaboration with patient groups. Objectives The objective of this study was to describe (i) how patients were involved in the development of SHF by summarizing a number of studies and (ii) a new survey on the importance and feasibility of SHF. Setting and participants In a series of participative studies, SHF was shaped, tested and implemented in 40 health-care institutions in Germany. Representatives from 157 self-help groups ( SHGs), 50 self-help organizations and 17 self-help clearing houses were actively involved. The second objective was reached through a survey of 74 of the 115 member associations of the biggest self-help umbrella organization at federal level (response rate: 64 %). Results Patient involvement included the following: identification of the needs and wishes of SHGs regarding co-operation, their involvement in the definition of quality criteria of co-operation, having a crucial role during the implementation of SHF and accrediting health-care institutions as self-help friendly. The ten criteria in total were positively valued and perceived as moderately practicable. Conclusions Through the intensive involvement of self-help representatives, it was feasible to develop SHF as a systematic approach to closer collaboration of professionals and SHGs. Some challenges have to be taken into account involving patients and the limitations of our empirical study. [ABSTRACT FROM AUTHOR]

Background: Potentially inappropriate medication (PIM) is defined as medication with uncertain therapeutic effects and/or potential adverse drug reactions outweighing the clinical benefits. The prescription rate of PIM for oldest-old patients is high despite the existence of lists of PIM (e.g. the PRISCUS list) and efforts to raise awareness. This study aims at identifying general practitioners' views on PIM and aspects affecting the (long-term) use of PIM. Methods: As part of the CIM-TRIAD study, we conducted semi-structured, qualitative interviews with 47 general practitioners, discussing 25 patients with and 22 without PIM (according to the PRISCUS list). The interview guideline included generic and patient-specific questions. Interviews were digitally recorded and transcribed verbatim. We content analyzed the interviews using deductive and inductive category development. Results: The majority of the general practitioners were not aware of the PRISCUS list. Agents deemed potentially inappropriate from the general practitioners' point of view and the PRISCUS list are not completely superimposable. General practitioners named their criteria to identify appropriate medication for elderly patients (e.g. renal function, cognitive state) and emphasized the importance of monitoring. We identified prescription- (e.g. benzodiazepines on alternative private prescription), medication- (e.g. subjective perception that PIM has no alternative), general practitioner- (e.g. general practitioner relies on specialists), patient- (e.g. "demanding high-user", positive subjective benefit-risk-ratio) and system-related aspects (e.g. specialists lacking holistic view, interface problems) related to the (long term) use of PIM. Conclusions: While the PRISCUS list does not seem to play a decisive role in general practice, general practitioners are well aware of risks associated with PIM. Our study identifies some starting points for a safer handling of PIM, e.g. stronger dissemination of the PRISCUS list, better compensation of medication reviews, "positive lists", adequate patient information, multifaceted interventions and improved communication between general practitioners and specialists. [ABSTRACT FROM AUTHOR]

Background: This study estimates life expectancy with and without type 2 diabetes for individuals in Lower Saxony, Germany in order to detect a trend in population health. Methods: Morbidity and mortality data derived from German administrative claims data (statutory health insurance, AOK Niedersachsen, N = 2,900,065) were used covering 10 years from 2005 to 2014. Life table analysis was applied for calculating life expectancy, life expectancy free of type 2 diabetes, life expectancy with type 2 diabetes, and the proportion of life expectancy free of diabetes to total life expectancy using the Sullivan method. Results: The total life expectancy increase is stronger in men than in women: At the age of 20, total life expectancy was 55.0 years in 2005 and 56.3 years in 2014 for men, whereas it was 61.7 years in 2005 and 62.5 years in 2014 for women. Decreases in life expectancy without type 2 diabetes were more pronounced in women than in men. Accordingly, life expectancy with type 2 diabetes increased in both women and in men. The proportion of life expectancy without diabetes to total life expectancy decreased, indicating a similar development in both. For example, at the age of 60, the proportion of life expectancy without diabetes to total life expectancy decreased from 0.75 in 2005 to 0.66 in 2014 for men, while it decreased from 0.77 in 2005 to 0.70 in 2014 for women. Conclusions: Against the background of increasing total life expectancy, the time spent in morbidity increased for the case of type 2 diabetes in Lower Saxony, Germany. [ABSTRACT FROM AUTHOR]

Background: Oral anticoagulation therapy (OAT) is a challenge in general practice, especially for high-risk groups such as the elderly. Insufficient patient knowledge about safety-relevant aspects of OAT is considered to be one of the main reasons for complications. The research question addressed in this manuscript is whether a complex intervention that includes practice-based case management, self-management of OAT and additional patient and practice team education improves patient knowledge about anticoagulation therapy compared to a control group of patients receiving usual care (as a secondary objective of the Primary Care Management for Optimised Antithrombotic Treatment (PICANT) trial). Methods: The cluster-randomised controlled PICANT trial was conducted in 52 general practices in Germany, between 2012 and 2015. Trial participants were patients with a long-term indication for oral anticoagulation. A questionnaire was used to assess knowledge at baseline, after 12, and after 24 months. The questionnaire consists of 13 items (with a range of 0 to 13 sum-score points) covering topics related to intervention. Differences in the development of patient knowledge between intervention and control groups compared to baseline were assessed for each follow-up by means of linear mixed-effects models. Results: Seven hundred thirty-six patients were included at baseline, of whom 95.4% continued to participate after 12 months, and 89.3% after 24 months. The average age of patients was 73.5 years (SD 9.4), and they mainly suffered from atrial fibrillation (81.1%). Patients in the intervention and control groups had similar knowledge about oral anticoagulation at baseline (5.6 (SD 2.3) in both groups). After 12 months, the improvement in the level of knowledge (compared to baseline) was significantly larger in the intervention group than in the control group (0.78 (SD 2.5) vs. 0.04 (SD 2.3); p = 0.0009). After 24 months, the difference between both groups was still statistically significant (0.6 (SD 2.6) vs. -0.3 (SD 2.3); p = 0.0001). Conclusion: Since this intervention was effective, it should be established in general practice as a means of improving patient knowledge about oral anticoagulation. Trial registration: Current controlled trials ISRCTN41847489; Date of registration: 13/04/2012 [ABSTRACT FROM AUTHOR]

BACKGROUND: Investigations in urban areas have just begun to explore how the indoor dust microbiome may affect the pathogenesis of asthma and allery. OBJECTIVE: We aimed to investigate the early fungal and bacterial microbiome in house dust with allergic sensitization and wheezing later in childhood. METHODS: Individual dust samples from 189 homes of the LISAplus birth cohort study were collected shortly after birth from living room floors and profiled for fungal and bacterial microbiome. Fungal and bacterial diversity was assessed with terminal restriction fragment length polymorphism (tRFLP) and defined by Simpson's Diversity Index. Information on wheezing outcomes and covariates until the age of 10 years was obtained by parent questionnaires. Information on specific allergic sensitization was available at child's age 6 and 10 years. Logistic regression and general estimation equation (GEE) models were used to examine the relationship between microbial diversity and health outcomes. RESULTS: Adjusted logistic regression analyses revealed a significantly reduced risk of developing sensitization to aero-allergens at 6 years and ever wheezing until the age of 10 years for exposure to higher fungal diversity [adjusted odds ratio (aOR) = 0.26 (95% CI: 0.10, 0.70), and 0.42 (95% CI: 0.18, 0.96), respectively]. The associations were attenuated for the longitudinal analyses (GEE) until the age of 10 years. There was no association between higher exposure to bacterial diversity and the tested health outcomes. CONCLUSION: Higher early exposure to fungal diversity might help to prevent a child from developing sensitization to aero-allergens in early childhood, but the reasons for attenuated effects in later childhood require further prospective studies. CITATION: Tischer C, Weikl F, Probst AJ, Standi M, Heinrich J, Pritsch K. 2016. Urban dust microbiome: impact on later atopy and wheezing. Environ Health Perspect 124:1919 -- 1923; http://dx.doi.org/10.1289/EHP158 [ABSTRACT FROM AUTHOR]

When investigating the association between brain tumors and use of mobile telephones, accurate data on tumor position are essential, due to the highly localized absorption of energy in the human brain from the radio-frequency fields emitted. We used a point process model to investigate this association using information that included tumor localization data from the INTERPHONE Study (Australia, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Sweden, and the United Kingdom). Our main analysis included 792 regular mobile phone users diagnosed with a glioma between 2000 and 2004. Similar to earlier results, we found a statistically significant association between the intracranial distribution of gliomas and the self-reported location of the phone. When we accounted for the preferred side of the head not being exclusively used for all mobile phone calls, the results were similar. The association was independent of the cumulative call time and cumulative number of calls. However, our model used reported side of mobile phone use, which is potentially influenced by recall bias. The point process method provides an alternative to previously used epidemiologic research designs when one is including localization in the investigation of brain tumors and mobile phone use. [ABSTRACT FROM AUTHOR]

Background: Based on animal research several authors have warned that the application of methylphenidate, the first-line drug for the treatment of attention-deficit/hyperactivity disorder (ADHD), might have neurotoxic effects potentially harming the brain. We investigated whether methylphenidate application, over a 1-year period, results in cerebral volume decrease. Methods: We acquired structural MRIs in a double-blind study comparing methylphenidate to placebo. Global and regional brain volumes were analyzed at baseline, after 3 months and after 12 months using diffeomorphic anatomic registration through exponentiated lie algebra. Results: We included 131 adult patients with ADHD into the baseline sample, 98 into the 3-month sample (54 in the methylphenidate cohort and 44 in the placebo cohort) and 76 into the 1-year sample (37 in the methylphenidate cohort and 29 in the placebo cohort). Methylphenidate intake compared with placebo did not lead to any detectable cerebral volume loss; there was a trend toward bilateral cerebellar grey matter increase. Limitations: Detecting possible neurotoxic effects of methylphenidate might require a longer observation period. Conclusion: There is no evidence of grey matter volume loss after 1 year of methylphenidate treatment in adult patients with ADHD. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to analyze prescription decisions for family practice (FP) patients with Diabetes mellitus type 2 (DM2) using the case of the incretin mimetics Dipeptidyl peptidase-4 (DDP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) agonists dependent on patients' health insurance status (statutory or private) in Germany. This study is important since the scientific debate is still open with regard to DPP-4-inhibitors and GLP-1-agonists, where some critics are raising questions on potential long-term risks for patients. Methods: Data for this analysis were sourced from the German health services research register CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork), in which FP health services information, generated by family practitioners, is continuously collated, e.g. patients' health insurance status, morbidity and pharmacotherapy. Patients with Diabetes mellitus type 1 (DM1) were excluded from the study. Results: From the family practices collaborating in the CONTENT research network, there were 7298 patients treated with pharmacotherapeutic agents for DM2 between 01.09.2009 and 31.08.2014. 586 (8.03 %) of these patients had private insurance. Prescriptions for the incretin mimetics were 40.6 % higher (9.7 vs. 6.9 %; p < 0.0001) for patients with private insurance compared to patients with statutory health insurance. This finding was confirmed with multivariable analyses. Conclusions: There was a statistically significant difference found in prescription patterns according to the patient's health insurance status for the incretin mimetics in this sample population of German patients with DM2. Obviously, these differences result from the eligibility for reimbursement according to patients' health insurance status. Whether incretin mimetics pose specific long term risks for particular patients is yet to be determined. [ABSTRACT FROM AUTHOR]

Background: Numerous observational studies have observed associations between vitamin D deficiency and cardiometabolic diseases, but these findings might be confounded by obesity. A characterization of the metabolic profile associated with serum 25-hydroxyvitamin D [25(OH)D] levels, in general and stratified by abdominal obesity, may help to untangle the relationship between vitamin D, obesity and cardiometabolic health.Methods: Serum metabolomics measurements were obtained from a nuclear magnetic resonance spectroscopy (NMR)- and a mass spectrometry (MS)-based platform. The discovery was conducted in 1726 participants of the population-based KORA-F4 study, in which the associations of the concentrations of 415 metabolites with 25(OH)D levels were assessed in linear models. The results were replicated in 6759 participants (NMR) and 609 (MS) participants, respectively, of the population-based FINRISK 1997 study.Results: Mean [standard deviation (SD)] 25(OH)D levels were 15.2 (7.5) ng/ml in KORA F4 and 13.8 (5.9) ng/ml in FINRISK 1997; 37 metabolites were associated with 25(OH)D in KORA F4 at P < 0.05/415. Of these, 30 associations were replicated in FINRISK 1997 at P < 0.05/37. Among these were constituents of (very) large very-low-density lipoprotein and small low-density lipoprotein subclasses and related measures like serum triglycerides as well as fatty acids and measures reflecting the degree of fatty acid saturation. The observed associations were independent of waist circumference and generally similar in abdominally obese and non-obese participants.Conclusions: Independently of abdominal obesity, higher 25(OH)D levels were associated with a metabolite profile characterized by lower concentrations of atherogenic lipids and a higher degree of fatty acid polyunsaturation. These results indicate that the relationship between vitamin D deficiency and cardiometabolic diseases is unlikely to merely reflect obesity-related pathomechanisms. [ABSTRACT FROM AUTHOR]

Background: Germany's enormous transformation away from nuclear energy and fossil fuels towards a renewable and energy efficient system--called the Energiewende--is playing an essential role in Germany's economy and policymaking. This article summarises the current knowledge on possible health impacts of the Energiewende and describes the need and opportunities to incorporate health into energy-related policy. Methods: A structural model helped to narrow down specific topics and to conceptualise links between the Energiewende, the environment and health. A comprehensive literature search was conducted within policy documents and scientific databases with English and German language selections. Results: Of 7800 publications first identified only 46 explicitly related energy measures to health, of which 40 were grey literature. Notably, only 12% published by health authorities all others were issued by environmental, energy or consumer protection agencies, ministries or institutions. Conclusion: Our study shows that health impacts of the German Energiewende are rarely explicitly addressed. An integration of a health perspective into energy-related policy is needed including the involvement of public health authorities. A health impact assessment can be a suitable tool to support and evaluate Energiewende-related developments from a health perspective. [ABSTRACT FROM AUTHOR]

Background: Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. Methods/design: The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Discussion: Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. [ABSTRACT FROM AUTHOR]

Background: Obesity is increasing worldwide and weight-control strategies, including the consumption of plant food supplements (PFS), are proliferating. This article identifies the herbal ingredients in PFS consumed for weight control and by overweight/obese dieters in six European countries, and explores the relationship between their consumption and their self-reported BMI. Methods: Data used were a subset from the PlantLIBRA PFS Consumer Survey 2011-2012, a retrospective survey of 2359 PFS consumers. The survey used a bespoke frequency-of-PFS-usage questionnaire. Analyses were performed in two consumer subsamples of 1) respondents taking the products for "body weight reasons", and 2) "dieters for overweight/obesity", to identify the herbal ingredients consumed for these reasons. The relationship between the 5 most consumed herbal ingredients and self-reported BMI in groups 1 and 2 is explored by comparing BMI proportions of consumers vs. non-consumers (using Chi-squared test). Results: 252 PFS (8.8 %) were consumed for "body weight reasons" (by 240 PFS consumers); 112 PFS consumers (4.8 %) were "dieting for overweight/obesity". Spain is the country where consuming herbal ingredients for body weight control and dieting were most popular. Artichoke was the most consumed herbal ingredient. Considering only the 5 top products consumed by those who responded "body weight", when using the total survey sample, a greater proportion of BMI ≥ 25 was observed among consumers of PFS containing artichoke and green tea as compared to non-consumers (58.4 % vs. 49.1 % and 63.2 % vs. 49.7 % respectively). Considering only the 5 top products consumed by "dieters" and using only the "dieters" sample, a lower proportion of BMI ≥ 25 was observed among pineapple-containing PFS consumers (38.5 % vs. 81.5 %); however, when using the entire survey sample, a greater proportion of BMI ≥ 25 was observed among artichoke-containing PFS consumers (58.4 % vs. 49.1 %). Conclusions: A comparison of results among the scarce publications evaluating the use of weight-loss supplements at the population level is limited. Nevertheless every hint is important in finding out which are the self-treatment strategies used by overweight/obese individuals in European countries. Although limited by a small sample size, our study represents a first attempt at analysing such data in six EU countries. Our findings should encourage the conduction of further studies on this topic, long-term and large sample-sized studies, ideally conducted in the general population. [ABSTRACT FROM AUTHOR]

BACKGROUND: Epidemiological studies have reported associations between particulate matter (PM) concentrations and cancer and respiratory and cardiovascular diseases. DNA methylation has been identified as a possible link but so far it has only been analyzed in candidate sites. OBJECTIVES: We studied the association between DNA methylation and short- and mid-term air pollution exposure using genome-wide data and identified potential biological pathways for additional investigation. METHODS: We collected whole blood samples from three independent studies-KORA F3 (2004-2005) and F4 (2006-2008) in Germany, and the Normative Aging Study (1999-2007) in the United States-and measured genome-wide DNA methylation proportions with the Illumina 450k BeadChip. PM concentration was measured daily at fixed monitoring stations and three different trailing averages were considered and regressed against DNA methylation: 2-day, 7-day and 28-day. Meta-analysis was performed to pool the study-specific results. RESULTS: Random-effect meta-analysis revealed 12 CpG (cytosine-guanine dinucleotide) sites as associated with PM concentration (1 for 2-day average, 1 for 7-day, and 10 for 28-day) at a genome-wide Bonferroni significance level (p ≤ 7.5E-8); 9 out of these 12 sites expressed increased methylation. Through estimation of I² for homogeneity assessment across the studies, 4 of these sites (annotated in NSMAF, C1orf212, MSGN1, NXN) showed p > 0.05 and I² < 0.5: the site from the 7-day average results and 3 for the 28-day average. Applying false discovery rate, p-value < 0.05 was observed in 8 and 1,819 additional CpGs at 7- and 28-day average PM2.5 exposure respectively. CONCLUSION: The PM-related CpG sites found in our study suggest novel plausible systemic pathways linking ambient PM exposure to adverse health effect through variations in DNA methylation. [ABSTRACT FROM AUTHOR]

The article reports on the participation of the research universities in Germany in a contest intended to improve their global ranking. The winners will receive thirty million euro for five years to help them compete with the likes of Harvard, Cambridge and Tokyo universities. There are also allegations that the competition is bound to be biased by political and regional considerations.

Background: Strong primary care systems are believed to have an important role in dealing with healthcare challenges. Strengthening primary care systems is therefore a common policy goal for many countries. This study aims to investigate whether the Netherlands, the UK and Germany have strengthened their primary care systems in 2006-2012. Method: For this cross-sectional study, data from the International Health Policy surveys of the Commonwealth Fund in 2006, 2009 and 2012 were used. The surveys represent the experiences and perspectives of primary care physicians with their primary care system. The changes over time were researched in three areas: organization of primary care processes, use of IT in primary care and use of benchmarking and financial incentives for performance improvement. Results: Regarding organization of primary care processes, in all countries the use of supporting personnel in general practice increased, but at the same time practice accessibility decreased. IT services were most advanced in the UK. The UK and the Netherlands showed increased use of performance feedback information. German GPs were least satisfied with how their system works across the 2006-2012 timeframe. Conclusion: All three countries show trends towards stronger primary care systems, although in different areas. Coordination and comprehensive care through the assignment of assisting personnel and use of disease management programs improved in all countries. In the Netherlands and the UK, informational continuity is in part ensured through better IT services. All countries showed increasing difficulties upholding primary care accessibility. [ABSTRACT FROM AUTHOR]

Aim: To estimate health-related quality of life (HRQOL) in patients with Duchenne muscular dystrophy (DMD).Method: HRQOL was assessed using the Health Utilities Index Questionnaire (HUI) and the Pediatric Quality of Life Inventory (PedsQL) neuromuscular module version 3.0 online. Results were stratified by disease stage (early/late ambulatory/non-ambulatory) and caregivers' perceptions of patients' health and mental status.Results: A total of 770 patient-caregiver pairs (173 German, 122 Italian, 191 UK, and 284 USA) participated. Most caregivers (>84%) perceived their patients as happy/somewhat happy and in excellent/very good/good health, irrespective of current ambulatory class. In contrast, mean patient utility (reflecting public preferences: 0, dead; 1, perfect health) deteriorated with disease course, from 0.75 in early ambulatory males to 0.15 in the most severely affected patients. Mean patient PedsQL scores (0-100, higher score indicating better HRQOL) decreased from 80 to 57 across ambulatory classes.Interpretation: HRQOL in DMD, measured through public preferences, is substantially impaired in relation to the general population and significantly associated with disease progression. Still, most patients are perceived as happy and in good health by their caregivers, indicating that influential domains of HRQOL remain intact through the disease progression. Our findings emphasize the challenges in measuring HRQOL in a rare, progressive childhood condition such as DMD. [ABSTRACT FROM AUTHOR]

Background: The maintenance of harmful alcohol use can be considered a reiterated decision in favour of alcohol in concrete drinking occasions. These decisions are often made despite an intention to quit or reduce alcohol consumption. We tested if a hyperactive reward system and/or an impaired cognitive control system contribute to such unfavourable decision-making. Methods: In this fMRI study, men with modest to harmful drinking behaviour, which was measured using the Alcohol Use Disorders Identification Test (AUDIT), repeatedly made decisions between alcoholic and nonalcoholic drinks. Based on prior individual ratings, decision pairs were created with an alcoholic decision option considered more desirable but less beneficial by the participant. By correlating AUDIT scores with brain activation during decision-making, we determined areas explicitly related to pro-alcohol decisions in men with greater drinking severity. Results: Thirty-eight men participated in our study. Behaviourally, we found a positive correlation between AUDIT scores and the number of decisions for desired alcoholic drinks compared with beneficial nonalcoholic drinks. The fMRI results show that AUDIT scores were positively associated with activation in areas associated with reward and motivation processing (i.e., ventral striatum, amygdala, medial prefrontal cortex) during decisions favouring a desired, nonbeneficial alcoholic drink. Conversely, we did not find hypoactivation in areas associated with self-control (dorsolateral prefrontal cortex). These effects were not present when participants chose a desired, nonbenefical, nonalcoholic drink. Limitations: The men participating in our study had to be abstinent and would potentially consume an alcoholic drink at the end of the experiment. Hence, we did not define manifest alcohol dependence as an inclusion criterion and instead focused on less severely affected individuals. Conclusion: Our results indicate that with growing drinking severity, decisions for alcoholic drinks are associated with increasing activity in reward-associated neural systems, rather than decreasing activity in self-control-associated systems. [ABSTRACT FROM AUTHOR]

Objective: Non-compliance with food record submission can induce bias in nutritional epidemiological analysis and make it difficult to draw inference from study findings. We examined the impact of demographic, lifestyle and psychosocial factors on such non-compliance during the first 3 years of participation in a multidisciplinary prospective paediatric study.Design: The Environmental Determinants of Diabetes in the Young (TEDDY) study collects a 3 d food record quarterly during the first year of life and semi-annually thereafter. High compliance with food record completion was defined as the participating families submitting one or more days of food record at every scheduled clinic visit.Setting: Three centres in the USA (Colorado, Georgia/Florida and Washington) and three in Europe (Finland, Germany and Sweden).Subjects: Families who finished the first 3 years of TEDDY participation (n 8096).Results: High compliance was associated with having a single child, older maternal age, higher maternal education and father responding to study questionnaires. Families showing poor compliance were more likely to be living far from the study centres, from ethnic minority groups, living in a crowded household and not attending clinic visits regularly. Postpartum depression, maternal smoking behaviour and mother working outside the home were also independently associated with poor compliance.Conclusions: These findings identified specific groups for targeted strategies to encourage completion of food records, thereby reducing potential bias in multidisciplinary collaborative research. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the tolerability, effectiveness and utilization of tocilizumab for the treatment of RA in a usual care setting. Methods. ROUTINE was a prospective, non-interventional, observational 52-week study performed at 174 sites throughout Germany. RA patients were selected and treated according to label. Study objectives included the targeted documentation of infections, other adverse events, and various effectiveness out-comes (e.g. DAS28, clinical disease activity). Statistical analyses were performed primarily based on the data as observed. Results. A total of 850 patients (75% women, mean age: 56 ±13 years, mean RA duration: 10.3 ±8.6 years) were enrolled. Most patients (79%) were pretreated with TNF-inhibitors, whereas 21% were pre-treated with conventional DMARDs only. Most common DMARD pretreatments were MTX (79%), LEF (68%), adalimumab (53%) and etanercept (50%). At baseline, 60.5% of patients received tocilizumab in combination with any other RA drugs, while 39.5% were treated in monotherapy. Mean baseline DAS28 was 5.5 ±1.3, and this decreased to 2.6 ±1.6 at week 52. At week 52, good EULAR response was achieved in 62.3%, low disease activity state in 66.4%, and DAS28 remission in 55.1 % of patients (ad-justed relative frequencies). 35.3% of patients discontinued the study prematurely; common reasons were lack of effectiveness (10.5%) and intolerability (7.3%). Any infections and severe infections occurred in 37.6% and 7.2% of patients, respectively (N = 836); serious infections were seen in 5.3% (N = 850). Event rates of any, severe and serious infections were 70.3, 9.8 and 4.4 events/100 patient-years, respectively. Conclusion. Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies. [ABSTRACT FROM AUTHOR]

Background: To investigate what a geriatric assessment in general practice adds towards previous findings of prevalence, location, impact and the dyadic doctor-patient perception of pain in this age group. Methods: Cross-sectional study. Consecutive patients aged 70 and over underwent a comprehensive geriatric assessment in general practice that included a basic pain assessment (severity, sites and impact). Patients with pain and their doctors then independently rated its importance. Pain was correlated with further findings from the assessment, such as overall health, physical impairments, everyday function, falls, mood, health related lifestyle, social circumstances, using bivariate and multivariate statistics. Patient-doctor agreement on the importance of pain was calculated using statistics. kappa Results: 219 out of 297 patients (73.7 %) reported pain at any location. Pain was generally located at multiple sites. It was most often present at the knee (33.9 %), the lumbar spine (33.5 %) as well as the hip (13.8 %) and correlated with specific impairments such as restrictions of daily living (knee) or sleep problems (spine). Patients with pain and their physicians poorly agreed on the importance of the pain problem. Conclusions: A basic pain assessment can identify older patients with pain in general practice. It has resulted in a high prevalence exceeding that determined by encounters in consultations. It has been shown that a geriatric assessment provides an opportunity to address pain in a way that is adapted to older patients' needs -- addressing all sites, its specific impact on life, and the patients' perceived importance of pain. Since there is little doctor-patient agreement, this seems a valuable strategy to optimize concrete treatment decisions and patient centered care. Trial registration: This study is registered in the German Clinical Trial Register (DRKS00000792) [ABSTRACT FROM AUTHOR]

Background: Previous resting-state functional connectivity studies in patients with anorexia nervosa used independent component analysis or seed-based connectivity analysis to probe specific brain networks. Instead, modelling the entire brain as a complex network allows determination of graph-theoretical metrics, which describe global and local properties of how brain networks are organized and how they interact. Methods: To determine differences in network properties between female patients with acute anorexia nervosa and pairwise matched healthy controls, we used resting-state fMRI and computed well-established global and local graph metrics across a range of network densities. Results: Our analyses included 35 patients and 35 controls. We found that the global functional network structure in patients with anorexia nervosa is characterized by increases in both characteristic path length (longer average routes between nodes) and assortativity (more nodes with a similar connectedness link together). Accordingly, we found locally decreased connectivity strength and increased path length in the posterior insula and thalamus. Limitations: The present results may be limited to the methods applied during preprocessing and network construction. Conclusion: We demonstrated anorexia nervosa-related changes in the network configuration for, to our knowledge, the first time using resting-state fMRI and graph-theoretical measures. Our findings revealed an altered global brain network architecture accompanied by local degradations indicating wide-scale disturbance in information flow across brain networks in patients with acute anorexia nervosa. Reduced local network efficiency in the thalamus and posterior insula may reflect a mechanism that helps explain the impaired integration of visuospatial and homeostatic signals in patients with this disorder, which is thought to be linked to abnormal representations of body size and hunger. [ABSTRACT FROM AUTHOR]