TY - JOUR AB - Introduction Cardiovascular diseases (CVDs) present differently in women and men, influenced by host-microbiome interactions. The roles of sex hormones in CVD outcomes and gut microbiome in modifying these effects are poorly understood. The XCVD study examines gut microbiome mediation of sex hormone effects on CVD risk markers by observing transgender participants undergoing gender-affirming hormone therapy (GAHT), with findings expected to extrapolate to cisgender populations. Methods and analyses This observational, longitudinal cohort study includes baseline, 1- and 2-year follow-ups with transgender participants beginning GAHT. It involves comprehensive phenotyping and microbiome genotyping, integrating computational analyses of high-dimensional data. Microbial diversity will be assessed using gut, skin, and oral samples via 16S rRNA and shotgun metagenomic sequencing of gut samples. Blood measurements will include sex hormones, CVD risk markers, cardiometabolic parameters, cytokines, and immune cell counts. Hair samples will be analysed for cortisol. Participants will complete online questionnaires on physical activity, mental health, stress, quality of life, fatigue, sleep, pain, and gender dysphoria, tracking medication use and diet to control for confounders. Statistical analyses will integrate phenomic, lifestyle, and multi-omic data to model health effects, testing gut microbiome mediation of CVD risk as the endocrine environment shifts between that typical for cisgender men to women and vice versa. Ethics and dissemination The study adheres to Good Clinical Practice and the Declaration of Helsinki. The protocol was approved by the Charit & eacute; Ethical Committee (EA1/339/21). Signed informed consent will be obtained. Results will be published in peer-reviewed journals and conferences and shared as accessible summaries for participants, community groups, and the public, with participants able to view their data securely after public and patient involvement review for accessibility. Trial registration number The XCVD study was registered on ClinicalTrials.gov (NCT05334888) as 'Sex-differential host-microbiome CVD risk - a longitudinal cohort approach (XCVD)" on 4 April 2022. Data set link can be found at https://classic.clinicaltrials.gov/ct2/show/NCT05334888. AU - Frank, K.* AU - Markó, L.* AU - Maehler, A.* AU - Chakaroun, R.* AU - Heinitz, S.* AU - Schlögl, H. AU - Sacher, J.* AU - Steckhan, N.* AU - Dechend, R.* AU - Adams, N.* AU - Andersen, M.K.* AU - Glintborg, D.* AU - Viehweger, M.* AU - Bahr, L.S.* AU - Forslund-Startceva, S.K.* C1 - 73275 C2 - 56975 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Sex hormone-dependent host-microbiome interactions and cardiovascular risk (XCVD): Design of a longitudinal multi-omics cohort study. JO - BMJ Open VL - 15 IS - 1 PB - Bmj Publishing Group PY - 2025 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: The identification of type 1 diabetes at an early presymptomatic stage has clinical benefits. These include a reduced risk of diabetic ketoacidosis (DKA) at the clinical manifestation of the disease and a significant reduction in clinical symptoms. The European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception (EDENT1FI) represents a pioneering effort to advance early detection of type 1 diabetes through public health screening. With the EDENT1FI Master Protocol, the project aims to harmonise and standardise screening for early-stage type 1 diabetes and care. METHODS AND ANALYSIS: Public health islet autoantibody screening is conducted in the Czech Republic, Denmark, Germany, Italy, Poland, Portugal, Sweden and the UK. Between November 2023 (start date) and October 2028 (planned end date), an estimated number of 200 000 children and adolescents aged 1-17 years are expected to be screened. Screening is performed in capillary blood, examining different islet autoantibodies (autoantibodies against insulin, glutamic acid decarboxylase-65, insulinoma-associated antigen-2 and/or zinc transporter-8). Positive screening results undergo confirmation through a second antibody method. A second (venous) blood sample is requested if at least two autoantibodies are detected, to confirm the autoantibody status. Children and adolescents with confirmed two or more autoantibodies are invited to metabolic staging (oral glucose tolerance test, haemoglobin A1c (HbA1c), random glucose, optionally continuous glucose monitoring); an educational programme and recommendations for monitoring are provided. The feasibility and acceptability of screening are evaluated by feedback questionnaires. Pseudonymised data is collated in the EDENT1FI Registry. Study outcomes include country-specific screening rates, prevalences of stage 1 and stage 2 type 1 diabetes, number in EDENT1FI Registry, proportion with DKA and symptoms at clinical diagnosis and median HbA1c. ETHICS AND DISSEMINATION: Following the EDENT1FI Master Protocol, site-specific protocols are developed and approved by local ethics committees (Technical University of Munich, Medical Faculty, Nr. 70/14; Medizinische Hochschule Hannover, Nr. 9588_BO_S_2021; Technische Universität Dresden, Nr. BO-EK-356082020; Center for Sundhed Region Hovedstaden, Nr. H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. PRE BIO CE Nr. 0059835; Charles University in Prague, Ethics Committee for Multi-Centric Clinical Trials of the University Hopital Motol and 2nd Faculty of Medicine, Nr. 1271/23; Bioethics Committee at the Medical University of Warsaw, Nr. 21/2024 and KB/6/R/2024; Associação Protectora dos Diabéticos de Portugal, Nr. 211/2024). Results are disseminated through peer-reviewed journals and conference presentations and will be shared openly. AU - Hoffmann, L. AU - Kohls, M. AU - Arnolds, S. AU - Achenbach, P. AU - Bergholdt, R.* AU - Bonifacio, E.* AU - Bosi, E.* AU - Gündert, M. AU - Höfelschweiger, B.K. AU - Hummel, S. AU - Jarosz-Chobot, P.* AU - Kordonouri, O.* AU - Lampasona, V.* AU - Narendran, P.* AU - Overbergh, L.* AU - Pociot, F.* AU - Raposo, J.F.* AU - Šumník, Z.* AU - Szypowska, A.* AU - Vercauteren, J.* AU - Winkler, C. AU - Mathieu, C.* AU - Ziegler, A.-G. C1 - 72945 C2 - 56877 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents. JO - BMJ Open VL - 15 IS - 1 PB - Bmj Publishing Group PY - 2025 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Patients with chronic somatic diseases such as obesity often develop comorbid depressive symptoms. E-mental health interventions are an innovative and effective treatment option within a stepped care approach. Studies have shown that acceptance and adherence are higher when they are tailored to the specific needs of the target group. This study protocol describes a randomised controlled trial (RCT) of an internet-based self-help intervention, Fit4Mood, to improve mental health in the high-risk group of adults with obesity. The objective of the @ktivPLUS research project is to evaluate the effectiveness, acceptability and cost-effectiveness of the intervention in comparison to an online bibliotherapy. METHODS AND ANALYSIS: Eligible individuals will be randomly allocated to an intervention group (access to an internet-based intervention) or to an active control group (access to an online bibliotherapy). Assessments will be conducted before the start of the intervention (baseline (BL)) and 4 months after BL (follow-up (FU)). The primary outcome is the reduction in depressive symptoms (Beck Depression Inventory-II) in n=190 participants. Secondary outcomes are anxiety, quality of life, activity, self-efficacy, resilience, mental and digital health literacy, stress, sleep quality, weight loss, weight management activities and readiness to lose weight, weight self-stigma, uptake, adherence and satisfaction with the intervention, workability and cost-effectiveness at follow-up. Additionally, sociodemographics, health, comorbidities and disabilities, as well as internet-specific information, will be assessed at BL. Intention-to-treat analysis using generalised linear mixed models will be applied. ETHICS AND DISSEMINATION: Approval for this study has been granted by the ethics committee of the University of Leipzig (ID: 140/25-ek). All participants will provide informed consent prior to participation in the study. Results will be disseminated in peer-reviewed journals and presented at national and international conferences. In the case of a successful evaluation, the internet-based self-help intervention Fit4Mood will be provided as freeware, which will be easily accessible and free of charge. TRIAL REGISTRATION NUMBER: The current RCT study has been registered at the German Clinical Trials Register (Identifier: DRKS00036178, Registered 24 June 2025; https://www.drks.de/search/de/trial/DRKS00036178). AU - Schladitz, K.* AU - Buß, A.* AU - Pabst, A.* AU - Welzel, F.D.* AU - Blüher, M. AU - Stumvoll, M. AU - Brettschneider, C.* AU - König, H.H.* AU - Riedel-Heller, S.G.* AU - Löbner, M.* C1 - 75965 C2 - 58286 TI - Effectiveness of an internet-based self-help intervention for improving mental health in individuals with obesity: Study protocol for a randomised controlled trial. JO - BMJ Open VL - 15 IS - 11 PY - 2025 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: The BIG project ('Bewegung als Investition in die Gesundheit', ie, 'Movement as Investment in Health') was developed in 2005 as a community-based participatory research programme to offer accessible opportunities for physical activity to women in difficult life situations. Since then, the programme has been expanded to eight sites in Germany. A systematic evaluation of BIG is currently being conducted. As part of this effort, we strive to understand the preferences of participating women for different aspects of the programme, and to analyse their willingness to pay. METHODS AND ANALYSIS: In this protocol, we describe the development and analysis plan of a discrete choice experiment (DCE) to investigate participants' preferences for a physical activity programme for women in difficult life situations. The experiment will be embedded in a questionnaire covering several aspects of participation in the programme (eg, reach, efficacy and further effects) and the socioeconomic characteristics of all active participants. After a thorough search of the literature, BIG documents review and expert interviews, we identified five important attributes of the programme: course times, travel time to the course venue, additional social activities organised by BIG, consideration of wishes and interests for the further planning of courses and costs per course unit. Thereafter, we piloted the experiment with a sample of participants from the target group. After data collection, the experiment will be analysed using a conditional logit model and a latent class analysis to assess eventual heterogeneity in preferences. ETHICS AND DISSEMINATION: Understanding women's preferences will provide useful insights for the further development of the programme and ultimately increase participation and retention. The questionnaire, the included DCE and the pretest on participants received ethical approval (application no. 20-247_1-B). We plan to disseminate the results of the DCE in peer-reviewed journals, national conferences and among participants and programme coordinators and organisers. AU - Pedron, S.* AU - Herbert-Maul, A.* AU - Sauter, A.* AU - Linder, S.* AU - Sommer, R.* AU - Vomhof, M.* AU - Gontscharuk, V.* AU - Abu-Omar, K.* AU - Thiel, A.* AU - Ziemainz, H.* AU - Holle, R.* AU - Laxy, M. C1 - 68094 C2 - 54572 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Preferences of women in difficult life situations for a physical activity programme: Protocol of a discrete choice experiment in the German NU-BIG project. JO - BMJ Open VL - 13 IS - 7 PB - Bmj Publishing Group PY - 2023 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Even well-treated gestational diabetes mellitus (GDM) might still have impact on long-term health of the mother and her offspring, although this relationship has not yet been conclusively studied. Using in-depth phenotyping of the mother and her offspring, we aim to elucidate the relationship of maternal hyperglycaemia during pregnancy and adequate treatment, and its impact on the long-term health of both mother and child. METHODS: The multicentre PREG study, a prospective cohort study, is designed to metabolically and phenotypically characterise women with a 75-g five-point oral glucose tolerance test (OGTT) during, and repeatedly after pregnancy. Outcome measures are maternal glycaemia during OGTTs, birth outcome and the health and growth development of the offspring. The children of the study participants are followed up until adulthood with developmental tests and metabolic and epigenetic phenotyping in the PREG Offspring study. A total of 800 women (600 with GDM, 200 controls) will be recruited. ETHICS AND DISSEMINATION: The study protocol has been approved by all local ethics committees. Results will be disseminated via conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: The PREG study and the PREG Offspring study are registered with Clinical Trials (ClinicalTrials.gov identifiers: NCT04270578, NCT04722900). AU - Fritsche, L. AU - Hummel, J. AU - Wagner, R. AU - Löffler, D. AU - Hartkopf, J. AU - Machann, J. AU - Hilberath, J.* AU - Kantartzis, K. AU - Jakubowski, P.* AU - Pauluschke-Fröhlich, J.* AU - Brucker, S.* AU - Hörber, S. AU - Häring, H.-U. AU - Roden, M.* AU - Schürmann, A.* AU - Solimena, M. AU - Hrabě de Angelis, M. AU - Peter, A. AU - Birkenfeld, A.L. AU - Preissl, H. AU - Fritsche, A. AU - Heni, M. C1 - 64363 C2 - 52021 TI - The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: Rationale, methodology and design. JO - BMJ Open VL - 12 IS - 2 PY - 2022 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Vertigo, dizziness and balance problems (VDB) as well as osteoarthritis (OA) are among the health conditions with the greatest impact on mobility and social participation in older adults. Patients with VDB and OA were shown to benefit from specialised care such as vestibular rehabilitation therapy or joint replacement. However, these effects are not permanent and seem to disappear over time. One important reason might be a decreasing adherence to therapy recommendations. Findings from behavioural economics (BE) can help to shed light on individual effects on adherence behaviour and long-term outcomes of VDB and OA. OBJECTIVE: Based on insights from BE concepts (ie, self-efficacy, intention, and time and risk preferences), MobilE-TRA 2 investigates the determinants of functioning and health-related quality of life (HRQoL) 3 and 12 months after discharge from total hip replacement (THR)/total knee replacement (TKR) in patients with OA and after interdisciplinary evaluation for VDB. METHODS AND ANALYSIS: MobilE-TRA 2 is a longitudinal observational study with data collection in two specialised tertiary care centres at the university hospital in Munich, Germany between 2020 and 2023. Patients aged 60 and older presenting for their first THR/TKR or interdisciplinary evaluation of VDB at Ludwig Maximilians University (LMU) hospital will be recruited for study participation. Three and twelve months after baseline assessment, all patients will receive a follow-up questionnaire. Mixed-effect regression models will be used to examine BE concepts as determinants of adherence, HRQoL and functioning. ETHICS AND DISSEMINATION: The study was approved by the ethics committee at the medical faculty of the LMU Munich under the number 20-727. Results will be published in scientific, peer-reviewed journals and at national and international conferences. Findings will also be disseminated via newsletters, the project website and a regional conference for representatives of local and national authorities. AU - Katzenberger, B.* AU - Schwettmann, L. AU - Weigl, M.* AU - Paulus, A.* AU - Pedron, S. AU - Fuchs, S.* AU - Koller, D.* AU - Grill, E.* C1 - 63793 C2 - 51761 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Behavioural and patient-individual determinants of quality of life, functioning and physical activity in older adults (MobilE-TRA 2): Study protocol of an observational cohort study in a tertiary care setting. JO - BMJ Open VL - 11 IS - 12 PB - Bmj Publishing Group PY - 2021 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: More than 17% of German children and adolescents have clinically relevant mental health problems (MHP). Typically, general paediatricians are often the first contact for children with MHP, and referrals to specialised care tend to be the standard approach. A statutory health insurance fund developed a programme for children with MHP (Health Coaching (HC)) aiming to offer targeted but low-threshold services. However, little is known about whether HC has the potential for optimising patient care. The aim of the PrimA-QuO study is to examine the effectiveness and the acceptance, barriers and facilitators of all stakeholders of this structured primary care programme for children affected by the most frequently encountered MHP in paediatric practice. METHODS AND ANALYSIS: In this mixed-methods approach, children (n=800; aged 0-17 years) with MHP meeting all inclusion criteria will be identified in the health insurance database according to International Classification of Diseases, 10th Revision diagnoses between 2018 and 2019. The qualitative component uses a series of semistructured interviews with programme developers, paediatricians trained in HC, adolescents with MHP treated according to the programme guidelines and their parents. In addition, a prospective, pragmatic, parallel-group cohort study will be conducted using an online questionnaire to examine the effects of HC on health-related quality of life of affected children and their families as well as on change in MHP. Children treated according to the HC guidelines form the intervention group, whereas all others serve as controls. Primary data from the cohort study are linked to children's health insurance claims data to calculate the costs of care as proxies for healthcare utilisation. The hypothesis is that HC is an effective and efficient primary care programme with the potential to improve patients' and their families' health outcomes. ETHICS AND DISSEMINATION: The study was approved by the Ethical Committee of Ludwig-Maximilians-Universität München. Grant number 01VSF16032 (funded by the German Innovationsfonds). AU - Loidl, V.* AU - Decke, S.* AU - Hamacher, K.* AU - Lang, M.* AU - Laub, O.* AU - Marijic, P. AU - Murawski, M. AU - Schwettmann, L. AU - Grill, E.* C1 - 62426 C2 - 50864 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Mixed-methods evaluation of a structured primary care programme for children and adolescents with mental health problems (PrimA-QuO): A study protocol. JO - BMJ Open VL - 11 IS - 7 PB - Bmj Publishing Group PY - 2021 SN - 2044-6055 ER - TY - JOUR AB - STUDY OBJECTIVES: To investigate the association between admission blood glucose levels and 28-day mortality as well as in-hospital complications in older patients with incident acute myocardial infarction (AMI) undergoing modern treatment. METHODS: From a German population-based regional MI registry, 5530 patients (2016 women), aged 65-84 years, hospitalised with an incident AMI between 1 January 2009 and 31 December 2016 were included in the study. Multivariable logistic regression models were used to assess the associations between admission blood glucose and 28-day mortality as well as in-hospital complications after AMI. Analyses stratified according to age, diabetes and type of infarction (ST-elevation MI (STEMI)/non-STEMI) were conducted. RESULTS: The adjusted ORs for the association between admission blood glucose and 28-day mortality in young-old (65-74 years) and old (75-84 years) patients with AMI were 1.40 (95% CI: 1.21 to 1.62) and 1.21 (95% CI: 0.98 to 1.50) per 1 SD increase in admission blood glucose, respectively. Furthermore, higher admission blood glucose was related to case fatality irrespective of the diabetes status and type of infarction only in the under-75 group. For the patients aged 75-84 years, it was only true for those without diabetes and STEMI. Admission blood glucose was also associated with major cardiac complications in both age groups. CONCLUSION: Admission blood glucose was significantly associated with 28-day case fatality in patients with AMI aged 65-74 years but not 75-84 years; furthermore, in both age groups there was an increased risk of major complications. It seems that admission glucose may play a rather minor role in terms of case fatality in higher aged patients with AMI. AU - Mamadjanov, T.* AU - Volaklis, K.* AU - Heier, M. AU - Freuer, D.* AU - Amann, U. AU - Peters, A. AU - Kuch, B.* AU - Thilo, C.* AU - Linseisen, J. AU - Meisinger, C.* C1 - 62198 C2 - 50721 TI - Admission glucose level and short-term mortality in older patients with acute myocardial infarction: Results from the KORA Myocardial Infarction Registry. JO - BMJ Open VL - 11 IS - 6 PY - 2021 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: The Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of Bifidobacterium infantis from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood. METHODS AND ANALYSIS: Infants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of B. infantis EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin. ETHICS AND DISSEMINATION: The study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study. TRIAL REGISTRATION NUMBER: NCT04769037. AU - Ziegler, A.-G. AU - Arnolds, S. AU - Koelln, A. AU - Achenbach, P. AU - Berner, R.* AU - Bonifacio, E.* AU - Casteels, K.* AU - Elding Larsson, H.* AU - Gündert, M. AU - Hasford, J.* AU - Kordonouri, O.* AU - Lundgren, M.* AU - Oltarzewski, M.* AU - Pekalski, M.L.* AU - Pfirrmann, M.* AU - Snape, M.D.* AU - Szypowska, A.* AU - Todd, J.A.* C1 - 63501 C2 - 51568 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Supplementation with Bifidobacterium longum subspecies infantis EVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised controlled trial protocol. JO - BMJ Open VL - 11 IS - 11 PB - Bmj Publishing Group PY - 2021 SN - 2044-6055 ER - TY - JOUR AB - Introduction Mental health is marked by gender differences. We formed a multi-cohort consortium to perform GEnder-Sensitive Analyses of mental health trajectories and study their implications for prevention (GESA). GESA aims at (1) identifying gender differences regarding symptoms and trajectories of mental health over the lifespan; (2) determining gender differences regarding the prevalence, impact of risk and protective factors; and (3) determining effects of mental health on primary and secondary outcomes (eg, quality of life, healthcare behaviour and utilisation).Methods and analysis We plan to perform secondary analyses on three major, ongoing, population-based, longitudinal cohorts (Gutenberg Health-Study (GHS), Study of Health in Pomerania (SHIP), Cooperative Health Research in the Augsburg Region (KORA)) with data on mental and somatic symptoms, medical assessments and diagnoses in north-east, middle and southern Germany (n>40 000). Meta-analytic techniques (using DataSHIELD framework) will be used to combine aggregated data from these cohorts. This process will inform about heterogeneity of effects. Longitudinal regression models will estimate sex-specific trajectories and effects of risk and protective factors and secondary outcomes.Ethics and dissemination The cohorts were approved by the ethics committees of the Statutory Physician Board of Rhineland-Palatinate (837.020.07; GHS), the University of Greifswald (BB 39/08; SHIP) and the Bavarian Chamber of Physicians (06068; KORA). Together with stakeholders in medical care and medical training, findings will be translated and disseminated into gender-sensitive health promotion and prevention. AU - Burghardt, J.* AU - Tibubos, A.N.* AU - Otten, D.* AU - Brähler, E.* AU - Binder, H.* AU - Grabe, H.J.* AU - Kruse, J.* AU - Ladwig, K.-H. AU - Schomerus, G.* AU - Wild, P.S.* AU - Beutel, M.E.* C1 - 58489 C2 - 48508 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - A multi-cohort consortium for GEnder-Sensitive Analyses of mental health trajectories and implications for prevention (GESA) in the general population in Germany. JO - BMJ Open VL - 10 IS - 2 PB - Bmj Publishing Group PY - 2020 SN - 2044-6055 ER - TY - JOUR AB - Introduction Insufficient physical activity is one of the most important risk factors for non-communicable diseases. Physical activity should therefore be intensively promoted in all age groups. Several trials suggest that it can be effectively increased through smartphone interventions.However, few of the smartphone-interventions available on the market have been scientifically evaluated. Therefore, the described study aims to assess the short-term and long-term effects of the smartphone intervention 'VIDEA bewegt' to increase physical activity. The trial is designed as a single-armed observational trial to assess effects under real-life conditions.Methods and analysis The intervention consists of the smartphone-application 'VIDEA bewegt', which is a video-based preventative programme to improve physical activity in everyday life. The application contains several features and components including educational videos, documentation of activity and motivational exercises. A sample size of at least 106 participants is aimed for. The primary objective of this study is to determine the effect of the application on physical activity in German adults. Secondary objectives are to evaluate the self-efficacy, health-related quality of life and usability of 'VIDEA bewegt'.Data collection is based on online questionnaires, as well as system-internal recorded data.Changes of outcomes from baseline to programme completion and follow-up will be calculated.Ethics and dissemination The Ethics Committee of the Technical University Dresden approved the study on 25 May 2019 (EK 272062019). All data are processed anonymously and stored on servers only accessible by authorised personnel. The results of the study and the results of the usability test are aimed to be published in a scientific journal. AU - Fischer, T.* AU - Stumpf, P.* AU - Reinhardt, G.* AU - Schwarz, P.E. AU - Timpel, P.* C1 - 58766 C2 - 48348 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Video-based smartphone app ('VIDEA bewegt') for physical activity support in German adults: A study protocol for a single-armed observational study. JO - BMJ Open VL - 10 IS - 3 PB - Bmj Publishing Group PY - 2020 SN - 2044-6055 ER - TY - JOUR AB - Objectives Knowledge about time trends of cancer incidence and cancer survival in a defined region is an essential prerequisite for the planning of regional healthcare infrastructure. The aim of the study was to provide population-based analyses of all common tumour sites to assess the cancer burden in the Augsburg study region. Setting Total population of the study region of Augsburg (668 522 residents), Southern Germany. Participants The data obtained from the Cancer Registry Augsburg comprised 37 487 incident cases of malignant tumours (19 313 men and 18 174 women) diagnosed between 2005 and 2016 in the Augsburg region's resident population. Primary and secondary outcome measures We calculated sex-specific, age-standardised incidence rates and annual percent change to assess time trends. In men and in women, 3-year and 5-year relative survival was calculated and results were compared with the latest German estimates. Survival trends were presented for the most common cancers only. Results Decreasing age-standardised incidence rates were observed for prostate cancer and for colorectal cancer in men. For oropharyngeal cancer, rates declined in men, but significantly increased in women. Incidence for female breast cancer remained stable. Five-year relative survival ranged between 6.4% (95% CI: 4.1% to 10.1%) for pancreatic cancer and 97.7% (95% CI: 96.0% to 99.4%) for prostate cancer in men and between 10.2% (95% CI: 7.1% to 14.6%) for pancreatic cancer and 96.6% (95% CI: 93.6% to 99.6%) for malignant melanoma in women. Trends in 3-year survival of the five most common tumour sites in men showed a significant increase for lung and oropharyngeal cancer. In women, continuously rising survival trends were observed for breast cancer. Conclusions Survival of cancer patients in the Augsburg study region was largely concordant with the situation in Germany as a whole, while incidence showed slight deviations in some cancer sites. Regional evaluations on cancer survival are a valuable instrument for identifying deficits and determining advances in oncological health management. AU - Grundmann, N. AU - Meisinger, C. AU - Trepel, M.* AU - Müller-Nordhorn, J.* AU - Schenkirsch, G.* AU - Linseisen, J. C1 - 60008 C2 - 49163 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Trends in cancer incidence and survival in the Augsburg study region-results from the Augsburg cancer registry. JO - BMJ Open VL - 10 IS - 8 PB - Bmj Publishing Group PY - 2020 SN - 2044-6055 ER - TY - JOUR AB - Objectives In 2012, Germany abolished copayment for consultations in ambulatory care. This study investigated the effect of the abolition on general practitioner (GP)-centred coordination of care. We assessed how the proportion of patients with coordinated specialist care changed over time when copayment to all specialist services were removed. Furthermore, we studied how the number of ambulatory emergency cases and apparent 'doctor shopping' changed after the abolition. Design A retrospective routine data analysis of the Bavarian Association of Statutory Health Insurance Physicians, comparing the years 2011 and 2012 (with copayment), with the period from 2013 to 2016 (without copayment). Therefore, time series analyses covering 24 quarters were performed. Setting Primary care in Bavaria, Germany. Participants All statutorily insured patients in Bavaria, aged >= 18 years, with at least one ambulatory specialist contact between 2011 and 2016. Primary and secondary outcome measures Primary outcome was the percentage of patients with GP-coordinated care (every regular specialist consultation within a quarter was preceded by a GP referral). Secondary outcomes were the number of ambulatory emergency cases and apparent 'doctor shopping'. Results After the abolition, the proportion of coordinated patients decreased from 49.6% (2011) to 15.5% (2016). Overall, younger patients and those living in areas with lower levels of deprivation showed the lowest proportions of coordination, which further decreased after abolition. Additionally, there were concomitant increases in the number of ambulatory emergency contacts and to a lesser extent in the number of patients with apparent 'doctor shopping'. Conclusions The abolition of copayment in Germany was associated with a substantial decrease in GP coordination of specialist care. This suggests that the copayment was a partly effective tool to support coordinated care. Future studies are required to investigate how the gatekeeping function of GPs in Germany can best be strengthened while minimising the associated administrative overhead. AU - Olm, M.* AU - Donnachie, E.* AU - Tauscher, M.* AU - Gerlach, R.* AU - Linde, K.* AU - Maier, W. AU - Schwettmann, L. AU - Schneider, A.* C1 - 60020 C2 - 49169 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Impact of the abolition of copayments on the GP-centred coordination of care in Bavaria, Germany: Analysis of routinely collected claims data. JO - BMJ Open VL - 10 IS - 9 PB - Bmj Publishing Group PY - 2020 SN - 2044-6055 ER - TY - JOUR AB - Introduction Ambient ozone exposure may be adverse to health. Since the reported associations between ozone and health effects are heterogeneous and the underlying pathways are indistinct, the overall relationship remains unclear. Only a few overall syntheses of the evidence regarding ozone and health effects are available to date. Methods and analysis We plan to summarise the current evidence on ozone-related health effects systematically. First, to identify the possible associations between ambient ozone exposure and health outcomes, we will conduct an umbrella review. PubMed, Web of Science and grey literature will be searched for systematic reviews on exposure to ambient ozone and any possible health endpoints published before 31 May 2019. Data selection and extraction will be carried out by one reviewer, and a second reviewer will check the agreement of a sample of the studies. The methodological quality of the eligible systematic reviews and level of evidence regarding ozone and every specific health effect will be evaluated. Second, for each of the identified effects with a high level of evidence, comprehensive information retrievals will be conducted, considering both epidemiological and experimental studies. The study selection and data mapping will be carried out by one reviewer and checked by the second reviewer. We will summarise the information of the filtered epidemiological and experimental studies to conduct several systematic maps presenting the currently available evidence for the specific health effect. Because the association between ozone exposure and chronic obstructive pulmonary disease (COPD) is relatively well investigated, we will at least conduct one systematic map of ozone and COPD. Ethics and dissemination No ethical approval is required for this study. The completed umbrella review and systematic maps will be considered for publication and presentation. We will additionally upload the relevant data to publicly accessible online databases. PROSPERO registration number CRD42019123064. AU - Zhao, T. AU - Markevych, I. AU - Janßen, C.* AU - Nowak, D.* AU - Steckling-Muschack, N.* AU - Heinrich, J. C1 - 59912 C2 - 48968 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Ozone exposure and health effects: A protocol for an umbrella review and effect-specific systematic maps. JO - BMJ Open VL - 10 IS - 8 PB - Bmj Publishing Group PY - 2020 SN - 2044-6055 ER - TY - JOUR AB - Introduction Depressive disorders are very common diseases entailing a great burden on affected people. However, comprehensive information on long-term disease course in patients with severe depression is lacking so far. The objectives of the DELTA study are to examine long-term outcomes and their predicting factors, to assess clinical response of antidepressant pharmacotherapy by applying therapeutic drug monitoring, to identify predictors of therapeutic non-response, to describe the long-term healthcare utilisation and to investigate the role of biomarkers in disease course.Methods and analysis A cohort study including all adult hospitalised cases (age range 18 to 75 years) of severe major depression who are admitted to the Bezirkskrankenhaus Augsburg is established. It is planned to include 300 patients. During the hospital stay, information is gathered through personal interview, self-administered questionnaires, cognitive tests and chart review. Furthermore, biomaterials are collected. After hospital discharge, patients are repeatedly re-examined over time (3, 6, 12, 24 and 36 months) to collect information about mortality, relapse, depression severity, health-related quality of life (HRQOL), perceived stigma, cognitive functions, diet, physical activity, treatment and healthcare utilisation. Follow-up blood samples are collected to determine therapeutic drug levels. The primary study aim is to investigate long-term therapeutic response, survival, relapse, HRQOL and cognitive functions. Survival time and time to relapse or re-hospitalisation will be analysed using Cox regression models. Changes of HRQOL, depressive symptoms and cognitive functions over time will be examined using generalised linear regression models for repeated measures or mixed models. Correlates of the disease course will be modelled using suitable generalised linear, mixed, estimating equation and growth curve models.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Ludwig-Maximilians-Universitat Munchen (date of approval: 23 October 2017, reference number: 17-625). Study results will be presented at scientific conferences and published in peer-reviewed scientific journals. AU - Kirchberger, I.* AU - Maleckar, B.* AU - Meisinger, C.* AU - Linseisen, J. AU - Schmauss, M.* AU - Baumgärtner, J.* C1 - 57719 C2 - 47978 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Long-term outcomes in patients with severe depression after in-hospital treatment - study protocol of the depression long-term Augsburg (DELTA) study. JO - BMJ Open VL - 9 IS - 12 PB - Bmj Publishing Group PY - 2019 SN - 2044-6055 ER - TY - JOUR AB - Introduction Acute pulmonary embolism (PE) is a frequent life-threatening event and an important cause of hospitalisation, morbidity and mortality worldwide. Limited information on the long-term course of PE patients is available so far. The Lungenembolie Augsburg study will provide a view on the predisposing and PE-provoking factors, diagnostic procedures and short as well as long-term treatment options. Especially, the data on the long-term course of the disease-in combination with omics data obtained in biospecimens-will generate new knowledge regarding triggers, disease progression, treatment, long-term sequelae, prognosis and prevention of disease recurrence.Methods and analysis In this prospective study, we will include about 1000 patients admitted to the university hospital of Augsburg, aged 18 years and older with a confirmed diagnosis of acute PE. At baseline, demographic information, symptoms on presentation, delay in diagnosis, predisposing and PE-provoking factors, comorbidity, quality of life, symptoms of anxiety and depression, information on invasive and non-invasive treatment procedures, complications and laboratory parameters will be collected. During the hospital stay, 30 mL blood will be collected from the patients, processed, aliquoted and frozen at -80 degrees C. In a subgroup of patients, an eight-channel polygraphy will be carried out to assess sleep-disordered breathing. All study participants will be followed up for 60 months via postal questionnaires or telephone interviews after hospital discharge. Long-term survival, bleeding complications and PE recurrence during the follow-up are the primary study outcomes. To identify risk factors and determinants associated with these outcomes, confounder-adjusted Cox-regressions will be used for modelling and to estimate relative risks. Effect modification by age and sex will be examined. AU - Meisinger, C. AU - Linseisen, J. AU - Kirchberger, I.* AU - von Scheidt, W.* AU - Berghaus, T.M.* C1 - 57217 C2 - 47617 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Long-term outcomes in patients with acute pulmonary embolism after in-hospital treatment: Study protocol of the prospective Lungenembolie Augsburg Studie (LEA study). JO - BMJ Open VL - 9 IS - 10 PB - Bmj Publishing Group PY - 2019 SN - 2044-6055 ER - TY - JOUR AB - Objectives This study aimed to assess the impact of using different weighting procedures for the German Index of Multiple Deprivation (GIMD) investigating their link to mortality rates.Design and setting In addition to the original (normative) weighting of the GIMD domains, four alternative weighting approaches were applied: equal weighting, linear regression, maximization algorithm and factor analysis. Correlation analyses to quantify the association between the differently weighted GIMD versions and mortality based on district-level official data from Germany in 2010 were applied (n=412 districts).Outcome measures Total mortality (all age groups) and premature mortality (<65 years).Results All correlations of the GIMD versions with both total and premature mortality were highly significant (p<0.001). The comparison of these associations using Williams's t-test for paired correlations showed significant differences, which proved to be small in respect to absolute values of Spearman's rho (total mortality: between 0.535 and 0.615; premature mortality: between 0.699 and 0.832).Conclusions The association between area deprivation and mortality proved to be stable, regardless of different weighting of the GIMD domains. The theory-based weighting of the GIMD should be maintained, due to the stability of the GIMD scores and the relationship to mortality. AU - Schederecker, F. AU - Kurz, C.F. AU - Fairburn, J.* AU - Maier, W. C1 - 56815 C2 - 47269 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Do alternative weighting approaches for an Index of Multiple Deprivation change the association with mortality? A sensitivity analysis from Germany. JO - BMJ Open VL - 9 IS - 8 PB - Bmj Publishing Group PY - 2019 SN - 2044-6055 ER - TY - JOUR AB - Purpose The Aussiedler Mortality cohorts represent the unique migrant group of ethnic Germans (resettlers) from the former Soviet Union who migrated to Germany mainly after the fall of the iron curtain in 1989. Resettlers are the second largest migrant group in Germany and their health status was largely unknown before the cohorts were set up.Participants Four retrospective register-based cohorts were set up in different federal states of Germany, each focussing on different health aspects. In total, the cohorts include 92 362 resettlers (men: 51.5%, women: 48.5%) who immigrated between 1990 and 2005 with a mean age at immigration of 36.6 years (range 0-105 years). Resettlers are of German ancestry and they are immediately granted the German citizenship with all rights and duties.Findings to date Vital status and causes of death (International Classification of Diseases codes based on death certificates or record linkage) were collected for three cohorts as well as cancer incidence and incidence of acute myocardial infarction in three of the cohorts. Currently, an observation period of 20 years (1990-2009) is covered. Overall mortality among resettlers was surprisingly lower in comparison to the German population with standardised mortality ratios of 0.87 (95% confidence limits 0.84-0.91) for women and 0.96 (0.92-0.99) for men, and even stronger for cardiovascular diseases (women: 0.84 (0.79-0.89); men: 0.80 (0.75-0.86). However, observed differences can neither be explained by the 'healthy migrant effect' nor by common behavioural risk factors and may be related to factors which have not yet been studied.Future plans The existing cohorts will be continued and prospective studies on resettlers are underway: one cohort will be followed-up prospectively and two other large prospective cohort studies in Germany will be used for a detailed assessment of lifestyle, environmental and genetic/epigenetic factors on the mortality and morbidity pattern of resettlers. AU - Winkler, V.* AU - Kaucher, S.* AU - Deckert, A.* AU - Leier, V.* AU - Holleczek, B.* AU - Meisinger, C. AU - Razum, O.* AU - Becher, H.* C1 - 55603 C2 - 46414 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Aussiedler Mortality (AMOR): Cohort studies on ethnic German migrants from the Former Soviet Union. JO - BMJ Open VL - 9 IS - 2 PB - Bmj Publishing Group PY - 2019 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: The POInT study, an investigator initiated, randomised, placebo-controlled, double-blind, multicentre primary prevention trial is conducted to determine whether daily administration of oral insulin, from age 4.0 months to 7.0 months until age 36.0 months to children with elevated genetic risk for type 1 diabetes, reduces the incidence of beta-cell autoantibodies and diabetes. METHODS AND ANALYSIS: Infants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype. Infants are randomised 1:1 to daily oral insulin (7.5 mg for 2 months, 22.5 mg for 2 months, 67.5 mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes. ETHICS AND DISSEMINATION: The study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial. TRIAL REGISTRATION NUMBER: NCT03364868. AU - Ziegler, A.-G. AU - Achenbach, P. AU - Berner, R.* AU - Casteels, K.* AU - Danne, T.* AU - Gündert, M. AU - Hasford, J.* AU - Hoffmann, V. AU - Kordonouri, O.* AU - Lange, K.* AU - Elding Larsson, H.* AU - Lundgren, M.* AU - Snape, M.D.* AU - Szypowska, A.* AU - Todd, J.A.* AU - Bonifacio, E.* AU - The GPPAD Study* C1 - 56414 C2 - 47063 TI - Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk: the GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol. JO - BMJ Open VL - 9 IS - 6 PY - 2019 SN - 2044-6055 ER - TY - JOUR AB - Objectives (1) To describe the accessibility of general practitioners (GPs) by the German population; (2) to determine factors on individual and area level, such as settlement structure and area deprivation, which are associated with the walking distance to a GP; and (3) to identify factors that may cause differences in the utilisation of any doctors.Design Cross-sectional study using individual survey data from the representative German Socio-Economic Panel (SOEP) linked with area deprivation data from the German Index of Multiple Deprivation for 2010 (GIMD 2010) and official data for settlement structure (urban/rural areas) at district level. Logistic regression models were estimated to determine the relationship of individual and area factors with the distance to a GP. Negative binomial regressions were used to analyse the association with utilisation.Setting Germany.Population n=20 601 respondents from the SOEP survey data 2009.Primary outcome measure Walking distance to a GP.Secondary outcome measure Doctor visits.Results Nearly 70% of the sample lives within a 20 min walk to a GP. People living in the most deprived areas have a 1.4-fold (95% CI 1.3 to 1.6) increased probability of a greater walking distance compared with the least deprived quintile, even after controlling for settlement structure and individual factors. In rural districts, people have a 3.1-fold (95% CI 2.8 to 3.4) higher probability of a greater walking distance compared with those in cities. Both area deprivation and rurality have a negative relationship with the utilisation of physicians, whereas the distance to a GP is not associated with the utilisation of physicians.Conclusion Walking distance to a GP depends on individual and area factors. In Germany, area deprivation is negatively correlated with the accessibility of GPs while controlling for settlement structure and individual factors. Both area factors are negatively associated with the utilisation of doctors. This knowledge could be used for future GP requirement plans. AU - Greiner, G. AU - Schwettmann, L. AU - Goebel, J.* AU - Maier, W. C1 - 54580 C2 - 45661 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Primary care in Germany: Access and utilisation - a cross-sectional study with data from the German Socio-Economic Panel (SOEP). JO - BMJ Open VL - 8 IS - 10 PB - Bmj Publishing Group PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - Objectives We aimed to prospectively study the association between normalised difference vegetation index (NDVI) as a measure of greenness around homes and occupational stress. Setting A population-based cohort in Munich and Dresden cities was followed from age 16-18 years to age 20-23 years (n=1632). Participants At baseline, all participants attended high-school while at follow-up some had started working and others studying at university. At baseline and in each follow-up, we assigned NDVI based on participants' residential geocoded addresses and categorised it by quartiles. Outcome measures School-related, university-related or job-related self-reported chronic stress was assessed at the two follow-ups by the Trier Scale for Assessment of Chronic Stress using work discontent and work overload as outcomes. We modelled the association employing ordinal generalised estimating equations model accounting for changes in sociodemographics, non-job-related stress, job history and environmental covariates. Stratified analysis by each city was performed. Results NVDI at baseline was higher for participants from Dresden (median=0.36; IQR 0.31-0.41) than Munich (0.31; 0.26-0.34). At follow-up, it decreased only for participants in Dresden (0.34; 0.30-0.40). Higher greenness (quartile 4 vs quartile 1) was associated with less work discontent (OR 0.89; 95% CI 0.80 to 0.99) and less work overload (OR 0.87; 95% CI 0.78 to 0.96). In stratified analyses, results were more consistent for Munich than for Dresden. Conclusions Our results suggest that residential green spaces, using the vegetation index as a proxy for exposure, are inversely associated with two types of job-related chronic stress in German young adults transitioning from school to university or working life. AU - Herrera, R.E.* AU - Markevych, I. AU - Berger, U.* AU - Genuneit, J.* AU - Gerlich, J.* AU - Nowak, D.* AU - Schlotz, W.* AU - Vogelberg, C.* AU - Von Mutius, E.* AU - Weinmayr, G.* AU - Windstetter, D.* AU - Weigl, M.* AU - Heinrich, J.* AU - Radon, K.* C1 - 53668 C2 - 44813 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Greenness and job-related chronic stress in young adults: A prospective cohort study in Germany. JO - BMJ Open VL - 8 IS - 6 PB - Bmj Publishing Group PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - Introduction Mobility limitations have a multitude of different negative consequences on elderly patients including decreasing opportunities for social participation, increasing the risk for morbidity and mortality. However, current healthcare has several shortcomings regarding mobility sustainment of older adults, namely a narrow focus on the underlying pathology, fragmentation of care across services and health professions and deficiencies in personalising care based on patients' needs and experiences. A tailored healthcare strategy targeted at mobility of older adults is still missing. Objective The objective is to develop multiprofessional care pathways targeted at mobility sustainment and social participation in patients with vertigo/dizziness/balance disorders (VDB) and osteoarthritis (OA). Methods Data regarding quality of life, mobility limitation, pain, stiffness and physical function is collected in a longitudinal observational study between 2017 and 2019. General practitioners (GPs) recruit their patients with VDB or OA. Patients who visited their GP in the last quarter will be identified in the practice software based on VDB and OA-related International Classification of Diseases 10th Revision. Study material will be sent from the practice to patients by mail. Six months and 12 months after baseline, all patients will receive a mail directly from the study team containing the follow-up questionnaire. GPs fill out questionnaires regarding patient diagnostics, therapy and referrals. Ethics and dissemination The study was approved by the ethical committee of the Ludwig-Maximilians-Universität München and of the Technische Universität Dresden. Results will be published in scientific, peer-reviewed journals and at national and international conferences. Results will be disseminated via newsletters, the project website and a regional conference for representatives of local and national authorities. AU - Kisch, R.* AU - Bergmann, A.* AU - Koller, D.* AU - Leidl, R. AU - Mansmann, U.* AU - Mueller, M.* AU - Sanftenberg, L.* AU - Schelling, J.* AU - Sundmacher, L.* AU - Voigt, K.* AU - Grill, E.* C1 - 53491 C2 - 44593 TI - Patient trajectories and their impact on mobility, social participation and quality of life in patients with vertigo/dizziness/balance disorders and osteoarthritis (MobilE-TRA): Study protocol of an observational, practice-based cohort study. JO - BMJ Open VL - 8 IS - 4 PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - Objective To assess the fidelity of general practitioners' (GPS) adherence to a long-term pragmatic trial protocol. Design Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010. Setting Primary care surgeries in the East of England. Study sample/participants A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40-69 years old with screen-detected diabetes mellitus. Interventions In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPS/nurses and patients, and GPS were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. Outcome measures The number of annual contacts between patients and GPS/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1-5 after diabetes diagnosis and the adherence to prescription algorithms. Results The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up. Conclusions The adherence of GPS to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. AU - Laxy, M. AU - Wilson, E.C.F.* AU - Boothby, C.E.* AU - Griffin, S.J.* C1 - 53984 C2 - 45169 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - How good are GPS at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial. JO - BMJ Open VL - 8 IS - 6 PB - Bmj Publishing Group PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - © 2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article). All rights reserved. Objectives To investigate the association between area deprivation at municipality level with low perceived social support, independent of individual socioeconomic position and demographic characteristics. To assess whether there are gender inequalities in this association. Design Cross-sectional multilevel analysis of survey data. Setting Germany. Participants 3350 men and 3665 women living in 167 municipalities throughout Germany participating in the German Health Interview and Examination Survey for Adults' (DEGS1 2008-2011) as part of the national health monitoring. Outcome Perceived social support as measured by Oslo-3 Social Support Scale. Results Prevalence of low perceived social support was 11.4% in men and 11.1% in women. Low social support was associated in men and women with sociodemographic characteristics that indicate more disadvantaged living situations. Taking these individual-level characteristics into account, municipal-level deprivation was independently associated with low perceived social support in men (OR for the most deprived quintile: 1.80 (95% CI 1.14 to 2.84)), but not in women (OR 1.22 (95% CI 0.78 to 1.90)). Conclusion The results of our multilevel analysis suggest that there are gender inequalities in the association of municipal-level deprivation with the prevalence of low perceived social support in Germany independent of individual socioeconomic position. Community health interventions aiming at promotion of social support among residents might profit from a further understanding of the observed gender differences. AU - Mena, E.* AU - Kroll, L.E.* AU - Maier, W. AU - Bolte, G.* C1 - 53401 C2 - 44581 TI - Gender inequalities in the association between area deprivation and perceived social support: A cross-sectional multilevel analysis at the municipality level in Germany. JO - BMJ Open VL - 8 IS - 4 PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - Objectives To assess the status and change in self-rated health among Aussiedler, ethnic German immigrants from the former Soviet Union, as a predictor for premature death 10 years after first assessment. Moreover, to identify subgroups which are particular at risk of anticipated severe health impairment.Design Cross-sectional questionnaire.Setting The study was conducted in the catchment area of Augsburg, a city in southern Bavaria, Germany, in 2011/2012 that has a large community of Aussiedler.Participants 595 Aussiedler (231 male, 364 female, mean age 55 years) who in majority migrated to Germany between 1990 and 1999.Outcome Primary outcome: self-rated health (very good/good/not so good/bad) and its association with demographic, social and morbidity related variables.Methods Self-rated health was dichotomised as 'very good' and 'good' versus 'not so good' and 'bad'. Multivariable logistic models were created. Missing values with regard to pain were addressed by a second analysis.Results Although low response suggests a healthier sample, the findings are alarming. Altogether47% of the Aussiedler perceived their health as less than good, which is worse compared with the first assessment in 2000 (25% compared with 20% of the general public). Prevalence of high blood pressure was present in 52% of Aussiedler, 34.5% were obese, 40.7% suffered from frequent pain and 13.1% had diabetes mellitus. According to the multivariable models, individuals suffering from pain, limited mobility, diabetes mellitus and high blood pressure are particularly in jeopardy.Conclusions 10 years after the first assessment of self-rated health among Aussiedler their situation deteriorated. Tailored risk factor counselling of general practitioners is highly recommended. AU - Stolpe, S.* AU - Ouma, M.* AU - Winkler, V.* AU - Meisinger, C.* AU - Becher, H.* AU - Deckert, A. C1 - 54600 C2 - 45706 CY - British Med Assoc House, Tavistock Square, London Wc1h 9jr, England TI - Self-rated health among migrants from the former Soviet Union in Germany: A cross-sectional study. JO - BMJ Open VL - 8 IS - 10 PB - Bmj Publishing Group PY - 2018 SN - 2044-6055 ER - TY - JOUR AB - Objectives A considerable proportion of regional variation in healthcare use and health expenditures is to date still unexplained. The aim was to investigate regional differences in the gatekeeping role of general practitioners and to identify relevant explanatory variables at patient and district level in Bavaria, Germany. Design Retrospective routine data analysis using claims data held by the Bavarian Association of Statutory Health Insurance Physicians. Participants All patients who consulted a specialist in ambulatory practice within the first quarter of 2011 (n = 3 616 510). Outcomes measures Of primary interest is the effect of district-level measures of rurality, physician density and multiple deprivation on (1) the proportion of patients with general practitioner (GP) coordination of specialist care and (2) the mean amount in Euros claimed by specialist physicians. Results The proportion of patients whose use of specialist services was coordinated by a GP was significantly higher in rural areas and in highly deprived regions, as compared with urban and less deprived regions. The hierarchical models revealed that increasing age and the presence of chronic diseases are the strongest predictive factors for coordination by a GP. In contrast, the presence of mental illness, an increasing number of medical condition categories and living in a city are predictors for specialist use without GP coordination. The amount claimed per patient was (sic)10 to (sic)20 higher in urban districts and in regions with lower deprivation. Hierarchical models indicate that this amount is on average higher for patients living in towns and lower for patients in regions with high deprivation. Conclusion The present study shows that regional deprivation is closely associated with the way in which patients access primary and specialist care. This has clear consequences, both with respect to the role of the general practitioner and the financial costs of care. AU - Mehring, M.* AU - Donnachie, E.* AU - Schneider, A.* AU - Tauscher, M.* AU - Gerlach, R.* AU - Storr, C.* AU - Linde, K.* AU - Mielck, A. AU - Maier, W. C1 - 52189 C2 - 43800 CY - London TI - Impact of regional socioeconomic variation on coordination and cost of ambulatory care: investigation of claims data from Bavaria, Germany. JO - BMJ Open VL - 7 IS - 10 PB - Bmj Publishing Group PY - 2017 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Atopic dermatitis (AD) is the most common skin disorder in young children worldwide, with a high impact on morbidity and quality of life. To date, no prospective study has been published on the incidence and potential predictors of AD in South East Asian populations. The Indonesian Prospective Study of Atopic Dermatitis in Infants (ISADI) will address the genetic, metabolic and dietary characteristics of mothers and their offspring, as well as potential determinants of AD within the first year of infant life. METHODS AND ANALYSIS: This prospective study will be undertaken in about 400 infants to investigate the direct and indirect effects of filaggrin (FLG) gene mutations, the genetic variants of FADS1, FADS2 and FADS3 and the role of long-chain polyunsaturated fatty acids (LCPUFA) on the development of AD. We will use standardised protocols for subject recruitment, umbilical artery plasma analysis, buccal cell sampling for genotyping, fatty acid analysis, physical exams, 3-day food-intake recall of mothers and children, as well as comprehensive questionnaires on environmental, socioeconomic and AD-related factors, including family history. Monthly monitoring by telephone and physical exams every 3 months will be carried out to assess participants' anthropometry, medical history and incidence of AD diagnosis during the first year of life. Hypotheses-driven analyses of quality-controlled dietary, genetic and metabolic data will be performed with state-of-the-art statistical methods (eg, AD-event history, haplotype, dietary or metabolic factor analysis). Direct and indirect effects of genetics and LCPUFA in buccal cell and cord plasma glycerophospholipids as potential mediators of inflammation on AD development will be evaluated by path analysis. ETHICS AND DISSEMINATION: The Permanent Medical Research Ethics Committee in Medicine and Health/Faculty of Medicine Universitas Indonesia/Dr Cipto Mangunkusumo Hospital (No. 47/H2.F1/ETIK/2014) approved the study protocol (extended by the letter no. 148/UN2.F1/ETIK/2015). We aim to disseminate our findings via publication in an international journal with high impact factor. AU - Tanjung, C.* AU - Rzehak, P.* AU - Mansyur, M.* AU - Munasir, Z.* AU - Sudoyo, H.* AU - Immanuel, S.* AU - Irawan, R.* AU - Reischl, E. AU - Demmelmair, H.* AU - Koletzko, B.* AU - Hadinegoro, S.R.* AU - Sjarif, D.R.* C1 - 50617 C2 - 42529 CY - London TI - Study protocol to investigate the environmental and genetic aetiology of atopic dermatitis: The Indonesian Prospective Study of Atopic Dermatitis in Infants (ISADI). JO - BMJ Open VL - 7 IS - 3 PB - Bmj Publishing Group PY - 2017 SN - 2044-6055 ER - TY - JOUR AB - Introduction Chronic low back pain (CLBP) produces considerable direct costs as well as indirect burdens for society, industry and health systems. CLBP is characterised by heterogeneity, inclusion of several pain syndromes, different underlying molecular pathologies and interaction with psychosocial factors that leads to a range of clinical manifestations. There is still much to understand in the underlying pathological processes and the non-psychosocial factors which account for differences in outcomes. Biomarkers that may be objectively used for diagnosis and personalised, targeted and cost-effective treatment are still lacking. Therefore, any data that may be obtained at the-omics' level (glycomics, Activomics and genome-wide association studies-GWAS) may be helpful to use as dynamic biomarkers for elucidating CLBP pathogenesis and may ultimately provide prognostic information too. By means of a retrospective, observational, case-cohort, multicentre study, we aim to investigate new promising biomarkers potentially able to solve some of the issues related to CLBP. Methods and analysis The study follows a two-phase, 1:2 case-control model. A total of 12 000 individuals (4000 cases and 8000 controls) will be enrolled; clinical data will be registered, with particular attention to pain characteristics and outcomes of pain treatments. Blood samples will be collected to perform-omics studies. The primary objective is to recognise genetic variants associated with CLBP; secondary objectives are to study glycomics and Activomics profiles associated with CLBP. Ethics and dissemination The study is part of the PainOMICS project funded by European Community in the Seventh Framework Programme. The study has been approved from competent ethical bodies and copies of approvals were provided to the European Commission before starting the study. Results of the study will be reviewed by the Scientific Board and Ethical Committee of the PainOMICS Consortium. The scientific results will be disseminated through peer-reviewed journals. Trial registration number NCT02037789; Pre-results. AU - Allegri, M.* AU - De Gregori, M.* AU - Minella, C.E.* AU - Klersy, C.* AU - Wang, W.* AU - Sim, M.* AU - Gieger, C. AU - Manz, J. AU - Pemberton, I.K.* AU - MacDougall, J.* AU - Williams, F.M.K.* AU - Van Zundert, J.* AU - Buyse, K.* AU - Lauc, G.* AU - Gudelj, I.* AU - Primorac, D.* AU - Skelin, A.* AU - Aulchenko, Y.S.* AU - Karssen, L.C.* AU - Kapural, L.* AU - Rauck, R.* AU - Fanelli, G.* C1 - 49897 C2 - 41907 CY - London TI - 'Omics' biomarkers associated with chronic low back pain: Protocol of a retrospective longitudinal study. JO - BMJ Open VL - 6 IS - 10 PB - Bmj Publishing Group PY - 2016 SN - 2044-6055 ER - TY - JOUR AB - OBJECTIVE: To compare the association between different anthropometric measurements and incident type 2 diabetes mellitus (T2DM) and to assess their predictive ability in different regions of Germany. METHODS: Data of 10 258 participants from 4 prospective population-based cohorts were pooled to assess the association of body weight, body mass index (BMI), waist circumference (WC), waist-to-hip-ratio (WHR) and waist-to-height-ratio (WHtR) with incident T2DM by calculating HRs of the crude, adjusted and standardised markers, as well as providing receiver operator characteristic (ROC) curves. Differences between HRs and ROCs for the different anthropometric markers were calculated to compare their predictive ability. In addition, data of 3105 participants from the nationwide survey were analysed separately using the same methods to provide a nationally representative comparison. RESULTS: Strong associations were found for each anthropometric marker and incidence of T2DM. Among the standardised anthropometric measures, we found the strongest effect on incident T2DM for WC and WHtR in the pooled sample (HR for 1 SD difference in WC 1.97, 95% CI 1.75 to 2.22, HR for WHtR 1.93, 95% CI 1.71 to 2.17 in women) and in female DEGS participants (HR for WC 2.24, 95% CI 1.91 to 2.63, HR for WHtR 2.10, 95% CI 1.81 to 2.44), whereas the strongest association in men was found for WHR among DEGS participants (HR 2.29, 95% CI 1.89 to 2.78). ROC analysis showed WHtR to be the strongest predictor for incident T2DM. Differences in HR and ROCs between the different markers confirmed WC and WHtR to be the best predictors of incident T2DM. Findings were consistent across study regions and age groups (<65 vs ≥65 years). CONCLUSIONS: We found stronger associations between anthropometric markers that reflect abdominal obesity (ie, WC and WHtR) and incident T2DM than for BMI and weight. The use of these measurements in risk prediction should be encouraged. AU - Hartwig, S.* AU - Kluttig, A.* AU - Tiller, D.* AU - Fricke, J.* AU - Müller, G.* AU - Schipf, S.* AU - Völzke, H.* AU - Schunk, M. AU - Meisinger, C. AU - Schienkiewitz, A.* AU - Heidemann, C.* AU - Moebus, S.* AU - Pechlivanis, S.* AU - Werdan, K.* AU - Kuss, O.* AU - Tamayo, T.* AU - Haerting, J.* AU - Greiser, K.H.* C1 - 47735 C2 - 39490 CY - London TI - Anthropometric markers and their association with incident type 2 diabetes mellitus: Which marker is best for prediction? Pooled analysis of four German population-based cohort studies and comparison with a nationwide cohort study. JO - BMJ Open VL - 6 IS - 1 PB - Bmj Publishing Group PY - 2016 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Type 1 diabetes can be diagnosed at an early presymptomatic stage by the detection of islet autoantibodies. The Fr1da study aims to assess whether early staging of type 1 diabetes (1) is feasible at a population-based level, (2) prevents severe metabolic decompensation observed at the clinical manifestation of type 1 diabetes and (3) reduces psychological distress through preventive teaching and care. METHODS AND ANALYSIS: Children aged 2-5 years in Bavaria, Germany, will be tested for the presence of multiple islet autoantibodies. Between February 2015 and December 2016, 100 000 children will be screened by primary care paediatricians. Islet autoantibodies are measured in capillary blood samples using a multiplex three-screen ELISA. Samples with ELISA results >97.5th centile are retested using reference radiobinding assays. A venous blood sample is also obtained to confirm the autoantibody status of children with at least two autoantibodies. Children with confirmed multiple islet autoantibodies are diagnosed with pre-type 1 diabetes. These children and their parents are invited to participate in an education and counselling programme at a local diabetes centre. Depression and anxiety, and burden of early diagnosis are also assessed. RESULTS: Of the 1027 Bavarian paediatricians, 39.3% are participating in the study. Overall, 26 760 children have been screened between February 2015 and November 2015. Capillary blood collection was sufficient in volume for islet autoantibody detection in 99.46% of the children. The remaining 0.54% had insufficient blood volume collected. Of the 26 760 capillary samples tested, 0.39% were positive for at least two islet autoantibodies. DISCUSSION: Staging for early type 1 diabetes within a public health setting appears to be feasible. The study may set new standards for the early diagnosis of type 1 diabetes and education. ETHICS DISSEMINATION: The study was approved by the ethics committee of Technische Universität München (Nr. 70/14). AU - Raab, J. AU - Haupt, F. AU - Scholz, M. AU - Matzke, C. AU - Warncke, K. AU - Lange, K.* AU - Assfalg, R. AU - Weininger, K. AU - Wittich, S. AU - Löbner, S. AU - Beyerlein, A. AU - Nennstiel-Ratzel, U.* AU - Lang, M.* AU - Laub, O.* AU - Dunstheimer, D.* AU - Bonifacio, E. AU - Achenbach, P. AU - Winkler, C. AU - Ziegler, A.-G. C1 - 48633 C2 - 41235 CY - London TI - Capillary blood islet autoantibody screening for identifying pre-type 1 diabetes in the general population: Design and initial results of the Fr1da study. JO - BMJ Open VL - 6 IS - 5 PB - Bmj Publishing Group PY - 2016 SN - 2044-6055 ER - TY - JOUR AB - OBJECTIVES: The efficiency of a gatekeeping system for a health system, as in Germany, remains unclear particularly as access to specialist ambulatory care is not restricted. The aim was to compare the costs of coordinated versus uncoordinated patients (UP) in ambulatory care; with additional subgroup analysis of patients with mental disorders. DESIGN: Retrospective routine data analysis of patients with statutory health insurance, using claims data held by the Bavarian Association of Statutory Health Insurance Physicians. A patient was defined as uncoordinated if he or she visited at least 1 specialist without a referral from a general practitioner within a quarter. Outcomes were compared with propensity score matching analysis. PARTICIPANTS: The study encompassed all statutorily insured patients in Bavaria contacting at least 1 ambulatory specialist in the first quarter of 2011 (n=3 616 510). PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was total costs of ambulatory care; secondary outcomes were financial claims of general physicians, specialists and for medication. RESULTS: The average age was 55.3 years for coordinated patients (CP, n=1 629 302), 48.3 years for UP (n=1 825 840). CP more frequently had chronic diseases (85.4%) as compared with UP (67.5%). The total unadjusted financial claim per patient was higher for UP (€234.52) than for CP (€224.41); the total adjusted difference was -€9.65 (95% CI -11.64 to -7.67), indicating lower costs for CP. The cost differences increased with increasing age. Total adjusted difference per patient with mental diseases as documented with an International Classification of Diseases (ICD)-10 F-diagnosis, was -€20.31 (95% CI -26.43 to -14.46). CONCLUSIONS: Coordination of care is associated with lower ambulatory healthcare expenditures and is of particular importance for patients who are more vulnerable to medical interventions, especially for elderly and patients with mental disorders. The role of general practitioners as coordinators should be strengthened to improve care for these patients as this could also help to frame a more efficient health system. AU - Schneider, A.* AU - Donnachie, E.* AU - Tauscher, M.* AU - Gerlach, R.* AU - Maier, W. AU - Mielck, A. AU - Linde, K.* AU - Mehring, M.* C1 - 48793 C2 - 41334 CY - London TI - Costs of coordinated versus uncoordinated care in Germany: Results of a routine data analysis in Bavaria. JO - BMJ Open VL - 6 IS - 6 PB - Bmj Publishing Group PY - 2016 SN - 2044-6055 ER - TY - JOUR AB - Objective To examine the impact of type 2 diabetes on direct and indirect costs and to describe the effect of relevant diabetes-related factors, such as type of treatment or glycaemic control on direct costs. Design Bottom-up excess cost analysis from a societal perspective based on population-based survey data. Participants 9160 observations from 6803 individuals aged 31–96 years (9.6% with type 2 diabetes) from the population-based KORA (Cooperative Health Research in the Region of Augsburg) studies in Southern Germany. Outcome measures Healthcare usage, productivity losses, and resulting direct and indirect costs. Methods Information on diabetes status, biomedical/sociodemographic variables, medical history and on healthcare usage and productivity losses was assessed in standardised interviews and examinations. Healthcare usage and productivity losses were costed with reference to unit prices and excess costs of type 2 diabetes were calculated using generalised linear models. Results Individuals with type 2 diabetes had 1.81 (95% CI 1.56 to 2.11) times higher direct (€3352 vs €1849) and 2.07 (1.51 to 2.84) times higher indirect (€4103 vs €1981) annual costs than those without diabetes. Cardiovascular complications, a long diabetes duration and treatment with insulin were significantly associated with increased direct costs; however, glycaemic control was only weakly insignificantly associated with costs. Conclusions This study illustrates the substantial direct and indirect societal cost burden of type 2 diabetes in Germany. Strong effort is needed to optimise care to avoid progression of the disease and costly complications.   AU - Ulrich, S. AU - Holle, R. AU - Wacker, M. AU - Stark, R. AU - Icks, A.* AU - Thorand, B. AU - Peters, A. AU - Laxy, M. C1 - 50074 C2 - 42002 CY - London TI - The cost burden of type 2 diabetes in Germany – Results from the population-based KORA Studies. JO - BMJ Open VL - 6 IS - 11 PB - Bmj Publishing Group PY - 2016 SN - 2044-6055 ER - TY - JOUR AB - INTRODUCTION: Tobacco smoking claims 700 000 lives every year in Europe and the cost of tobacco smoking in the EU is estimated between €98 and €130 billion annually; direct medical care costs and indirect costs such as workday losses each represent half of this amount. Policymakers all across Europe are in need of bespoke information on the economic and wider returns of investing in evidence-based tobacco control, including smoking cessation agendas. EQUIPT is designed to test the transferability of one such economic evidence base-the English Tobacco Return on Investment (ROI) tool-to other EU member states. METHODS AND ANALYSIS: EQUIPT is a multicentre, interdisciplinary comparative effectiveness research study in public health. The Tobacco ROI tool already developed in England by the National Institute for Health and Care Excellence (NICE) will be adapted to meet the needs of European decision-makers, following transferability criteria. Stakeholders' needs and intention to use ROI tools in sample countries (Germany, Hungary, Spain and the Netherlands) will be analysed through interviews and surveys and complemented by secondary analysis of the contextual and other factors. Informed by this contextual analysis, the next phase will develop country-specific ROI tools in sample countries using a mix of economic modelling and Visual Basic programming. The results from the country-specific ROI models will then be compared to derive policy proposals that are transferable to other EU states, from which a centralised web tool will be developed. This will then be made available to stakeholders to cater for different decision-making contexts across Europe. ETHICS AND DISSEMINATION: The Brunel University Ethics Committee and relevant authorities in each of the participating countries approved the protocol. EQUIPT has a dedicated work package on dissemination, focusing on stakeholders' communication needs. Results will be disseminated via peer-reviewed publications, e-learning resources and policy briefs. AU - Pokhrel, S.* AU - Evers, S.* AU - Leidl, R. AU - Trapero-Bertran, M.* AU - Kalo, Z.* AU - Vries, H.d.* AU - Crossfield, A.* AU - Andrews, F.* AU - Rutter, A.* AU - Coyle, K.* AU - Lester-George, A.* AU - West, R.* AU - Owen, L.* AU - Jones, T.* AU - Vogl, M. AU - Radu-Loghin, C.* AU - Voko, Z.* AU - Huic, M.* AU - Coyle, D.* C1 - 42834 C2 - 35418 TI - EQUIPT: Protocol of a comparative effectiveness research study evaluating cross-context transferability of economic evidence on tobacco control. JO - BMJ Open VL - 4 IS - 11 PY - 2014 SN - 2044-6055 ER - TY - JOUR AB - OBJECTIVE: To analyse gender differences in the relationship of individual social class, employment status and neighbourhood unemployment rate with present type 2 diabetes mellitus (T2DM). DESIGN: Five cross-sectional studies. SETTING: Studies were conducted in five regions of Germany from 1997 to 2006. PARTICIPANTS: The sample consisted of 8871 individuals residing in 226 neighbourhoods from five urban regions. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalent T2DM. RESULTS: We found significant multiplicative interactions between gender and the individual variables--social class and employment status. Social class was statistically significantly associated with T2DM in men and women, whereby this association was stronger in women (lower vs higher social class: OR 2.68 (95% CIs 1.66 to 4.34)) than men (lower vs higher social class: OR 1.78 (95% CI 1.22 to 2.58)). Significant associations of employment status and T2DM were only found in women (unemployed vs employed: OR 1.73 (95% CI 1.02 to 2.92); retired vs employed: OR 1.77 (95% CI 1.10 to 2.84); others vs employed: OR 1.64 (95% CI 1.01 to 2.67)). Neighbourhood unemployment rate was associated with T2DM in men (high vs low tertile: OR 1.52 (95% CI 1.18 to 1.96)). Between-study and between-neighbourhood variations in T2DM prevalence were more pronounced in women. The considered covariates helped to explain statistically the variation in T2DM prevalence among men, but not among women. CONCLUSIONS: Social class was inversely associated with T2DM in both men and women, whereby the association was more pronounced in women. Employment status only affected T2DM in women. Neighbourhood unemployment rate is an important predictor of T2DM in men, but not in women. AU - Müller, G.* AU - Hartwig, S.* AU - Greiser, K.H.* AU - Moebus, S.* AU - Pundt, N.* AU - Schipf, S.* AU - Völzke, H.* AU - Maier, W. AU - Meisinger, C. AU - Tamayo, T.* AU - Rathmann, W.* AU - Berger, K.* AU - DIAB-CORE Consortium (*) C1 - 26202 C2 - 32120 TI - Gender differences in the association of individual social class and neighbourhood unemployment rate with prevalent type 2 diabetes mellitus: A cross-sectional study from the DIAB-CORE Consortium. JO - BMJ Open VL - 3 IS - 6 PB - BMJ Publishing PY - 2013 SN - 2044-6055 ER -