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Background: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor's practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany.Methods: The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires).Results: The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated-for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders.Conclusion: The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor's settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project's extension phase. [ABSTRACT FROM AUTHOR]

Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

Background: The so-called sports consumption models are looking for the factors that influence the sports spending of households. This paper aims to examine the Hungarian, Polish and German households' sports expenditures which can be an important indicator of physical activity and sporty lifestyle.Methods: Surveying of households in three countries (Hungary, Poland and Germany) has been conducted with a self-designed questionnaire. We have used descriptive and bivariate non-parametric and parametric statistical methods: (1) χ2 test, Mann-Whitney test and Kruskal-Wallis test for checking the relationship between sociodemographic and physical activity variables and (2) independent sample t-test and ANOVA for checking the differences in sports expenditures.Results: Our research concluded that men, especially previous athletes, exercise more than women and those who have no history as registered athletes. The choice of sports venues is obviously different between the countries in the sample. Members of the study population spend the most on sports services while they spend the least on sports equipment. German households have the highest spending rates compared to the other two countries.Conclusions: Results are in line with our previous research findings and with other literatures. The difference in preferences of sports venues could have the reason of different supply of sports clubs or the different living standards too. It needs further researches to clear it. Material wealth, income level and sport socialisation can be a determining factor regarding the level of sports spending. [ABSTRACT FROM AUTHOR]

Background: Little is known about the management of methicillin-resistant Staphylococcus aureus (MRSA) carriers in the German outpatient sector and about the impact of MRSA on their daily life. Reimbursement for MRSA related costs in the German outpatient sector is available since 2012, but its impact has not been studied yet. The aim of the study was to analyze the outpatient management of MRSA carriers from both, physicians' and MRSA carriers' perspective.Methods: Paper-based questionnaires were mailed to physicians providing outpatient care and to MRSA carriers in 2013. MRSA carriers were recruited among patients tested positive for MRSA during a hospital stay in 2012. General practitioners, specialists for internal medicine, urologists, and dermatologists working in the outpatient catchment areas of the hospitals were contacted.Results: Out of 910 MRSA carriers 16.5 % completed the questionnaires; among 851 physicians 9.5 % participated. 27.3 % of the responding MRSA carriers stated that no healthcare professional had ever talked to them about MRSA. 17.4 % reported self-stigmatization in terms of restricting social contacts; 47.3 % remembered decolonization and 33.3 % reported that their MRSA status was checked after discharge. Physicians displayed heterogeneous attitude and activity towards MRSA (number of applied decolonization and MRSA screenings). A minority (15.2 %) were satisfied with the reimbursement of costs, 35.9 % reported full agreement with the general recommendations for the handling of MRSA carriers.Conclusions: MRSA carriers appear not well informed; (self-) stigmatization is occurring and should be tackled. Greater awareness of MRSA as a problem in the outpatient sector could lead to a better handling of MRSA carriers. [ABSTRACT FROM AUTHOR]

Background: Nosocomial infections are the most common complication during inpatient hospital care. An increasing proportion of these infections are caused by multidrug-resistant organisms (MDROs). This report describes an intervention study which was designed to address the practical problems encountered in trying to avoid and treat infections caused by MDROs. The aim of the HARMONIC (Harmonized Approach to avert Multidrug-resistant Organisms and Nosocomial Infections) study is to provide comprehensive support to hospitals in a defined study area in north-east Germany, to meet statutory requirements. To this end, a multimodal system of hygiene management was implemented in the participating hospitals.Methods/design: HARMONIC is a controlled intervention study conducted in eight acute care hospitals in the 'Health Region Baltic Sea Coast' in Germany. The intervention measures include the provision of written recommendations on methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE) and multi-resistant Gram-negative bacteria (MRGN), supplemented by regional recommendations for antibiotic prescriptions. In addition, there is theoretical and practical training of health care workers (HCWs) in the prevention and handling of MDROs, as well as targeted and critically gauged applications of antibiotics. The main outcomes of the implementation and analysis of the HARMONIC study are: (i) screening rates for MRSA, VRE and MRGN in high-risk patients, (ii) the frequency of MRSA decolonization, (iii) the level of knowledge of HCWs concerning MDROs, and (iv) specific types and amounts of antibiotics used. The data are predominantly obtained by paper-based questionnaires and documentation sheets. A computer-assisted workflow-based documentation system was developed in order to provide support to the participating facilities. The investigation includes three nested studies on risk profiles of MDROs, health-related quality of life, and cost analysis. A six-month follow-up study investigates the quality of life after discharge, the long-term costs of the treatment of infections caused by MDROs, and the sustainability of MRSA eradication.Discussion: The aim of this study is to implement and evaluate an area-wide harmonized hygiene program to control the nosocomial spreading of MDROs. Comparability between the intervention and control group is ensured by matching the hospitals according to size (number of discharges per year/number of beds) and level of care (standard or maximum). The results of the study may provide important indications for the implementation of regional MDRO management programs. [ABSTRACT FROM AUTHOR]

This paper examines the paper of Haux et al. in this issue of this journal. It gives some background on specifics of the German health care system, which underlie the theses and prognoses proposed by Haux et al. In analogy to a forecast of the future of health informatics, which is now 10 years old, I then suggest that these attempts meet two types of challenges:•that of overestimating the positive effects of recent advances, which later are found not to scale up; and•that of blind spots with respect to unforeseen significant advances.The attempt to find indications of such in the projections of Haux et al. leads, among other, to the conclusion that the projections of direct linkages between patients and care providers may be overoptimistic. As to wheather the deviating opinions matter in the end, it is concluded that the technology advances may require less attention that the restructuring of the health care system required to take advantage of the advances of technology. [Copyright &y& Elsevier]

Background: Parents often use digital media to search for information related to their children's health. As the quantity and quality of digital sources meant specifically for parents expand, parents' digital health literacy is increasingly important to process the information they retrieve. One of the earliest developed and widely used instruments to assess digital health literacy is the self-reported eHealth Literacy Scale (eHEALS). However, the eHEALS has not been psychometrically validated in a sample of parents. Given the inconsistency of the eHEALS underlying factor structure across previous reports, it is particularly important for validation to occur.Objective: This study aimed to determine the factor structure of the German eHEALS measure in a sample of parents by adopting classic and modern psychometric approaches. In particular, this study sought to identify the eHEALS validity as a unidimensional index as well as the viability for potential subscales.Methods: A cross-sectional design was used across two purposive sampling frames: online and paper administrations. Responses were collected between January 2018 and May 2018 from 703 Swiss-German parents. In addition to determining the sampling characteristics, we conducted exploratory factor analysis of the eHEALS by considering its ordinal structure using polychoric correlations. This analysis was performed separately for online-based and paper-based responses to examine the general factor strength of the eHEALS as a unidimensional index. Furthermore, item response theory (IRT) analyses were conducted by fitting eHEALS to a bifactor model to further inspect its unidimensionality and subscale viability.Results: Parents in both samples were predominantly mothers (622/703, 88.5%), highly educated (538/703, 76.9%), of Swiss nationality (489/703, 71.8%), and living with a partner (692/703, 98.4%). Factor analyses of the eHEALS indicated the presence of a strong general factor across both paper and online samples, and the Wilcoxon rank-sum test indicated that the eHEALS total sum score was not significantly different between the paper and online samples (P=.12). Finally, the IRT analyses indicated negligible multidimensionality, insufficient subscale reliability after accounting for the eHEALS general factor, and a reduced subset of items that could serve as a unidimensional index of the eHEALS across the paper and online samples.Conclusions: The German eHEALS evidenced good psychometric properties in a parent-specific study sample. Factor analyses indicated a strong general factor across purposively distinct sample frames (online and paper). IRT analyses validated the eHEALS as a unidimensional index while failing to find support for subscale usage. [ABSTRACT FROM AUTHOR]

Background: There is only few data available on the use of cryotechnique during medical thoracoscopy.Methods: Medical thoracoscopy was performed in consecutive patients with pleural effusion. Prospectively, biopsies were taken by rigid forceps, flexible forceps and cryoprobe. Specimen size, depth and diagnostic yield were compared.Results: 80 Patients were included. 408 biopsies were taken (205 rigid biopsies, 104 flexible biopsies, 99 cryobiopsies). Mean surface area of rigid biopsies was 22.6 ± 20.4 mm(2) (flexible biopsies: 7.1 ± 9.3 mm(2), cryobiopsies: 14.4 ± 12.8 mm(2)). Rigid biopsies were significantly larger than cryobiopsies (p < 0.001) and flexible biopsies (p < 0.001), crybiopsies were significantly larger than flexible biopsies (p < 0.01). A deep biopsy containing fatty tissue was harvested in 63 % of rigid biopsies (cryobiopsy: 49.5 % flexible biopsy: 39.5 %). In 79/80 cases (98.7 % 95 % CI cannot be calculated) a diagnosis was obtained by rigid biopsy (cryobiopsy: 73/80 cases (91.3 % 95 % CI 86.0 - 96.5 %), flexible biopsy: 74/80 cases (92.5 % 95 % CI 88.6 - 97.4 %)). Diagnostic yield achieved with cryobiopsies was inferior to the yield of rigid biopsies (Difference: 12.7 %), but non-inferior to flexible biopsies (Difference: 6.5 %).Conclusion: Cryobiopsies in medical thoracoscopy are safe with high diagnostic yield, non-inferior to flexible biopsies with increased tissue quantity and quality. Cryotechnique can develop an important role in medical thoracoscopy in the near future when rigid thoracoscopy is not available. [ABSTRACT FROM AUTHOR]

Objectives: The present study aimed to assess the current state of breast-feeding promotion in hospitals and the prevalence of breast-feeding during the first year of life in Germany and to compare the results with a study 20 years earlier.Design: In the studies on 'breast-feeding and infant nutrition in Germany' named 'SuSe', a cross-sectional survey in hospitals was combined with a subsequent prospective survey of breast-feeding and infant nutrition during the first year of life (0·5, 2, 4, 6 and 12 months after birth) in mother-infant pairs who were recruited in the hospitals. Written questionnaires and phone calls were used in SuSe I and web-based questionnaires in SuSe II. Breast-feeding promotion and prevalence were evaluated using recommendations from the WHO and the UNICEF.Setting: Two nationwide surveys SuSe I (1997-1998) and SuSe II (2017-2019).Participants: In SuSe I, 177 hospitals and 1717 mother-infant pairs and in SuSe II 109 hospitals and 962 mother-infant pairs were included.Results: In SuSe II, hospitals implemented seven of the WHO 'Ten Steps to Successful Breastfeeding' to a greater extent than the hospitals in SuSe I. More mothers exclusively breastfed for 4 months (57 % v. 33 %) and continued breast-feeding until 6 (78 % v. 48 %) and 12 months (41 % v. 13 %). In both studies, exclusive breast-feeding decreased between 4 and 6 months of age due to the introduction of complementary feeding.Conclusions: In Germany, breast-feeding habits have come closer to the recommendations over the last 20 years. [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: Smell, taste and trigeminal disorders likely have a substantial impact on human daily life. However, data regarding the prevalence of these disorders in Norway are scarce. The aim of this study was to investigate the prevalence of smell, taste, trigeminal disorders and associated factors in a 65-year-old population in Oslo, Norway.Methods: A random sample of 223 individuals (123 men, 100 women) participated in the study. Medical history was obtained, and unstimulated whole saliva (UWS) and stimulated whole saliva (SWS) were collected to determine salivary secretion rates. Sniffin`n Sticks and Taste Strips (Burghart Messtechnik GmbH, Wedel, Germany) were used for quantitative testing of olfactory and gustatory function. In addition, the participants' self-reported perceptions of smell and taste, and burning mouth sensation were investigated.Results: The results showed that 34 % of the participants had reduced smell (28 % hyposmia and 6 % anosmia) and 28 % had reduced taste perception (21 % hypogeusia and 7 % ageusia). 13 % of the partcipants had a combination of smell and taste disorders. Dysgeusia was reported by 5 % and burning mouth sensation (syndrome) by 3 % of the participants. Hyposmia, hypogeusia and ageusia were significantly more prevalent among men. Significant associations were found between taste disorders and previous history of cerebral hemorrhage and heart attack, and between burning mouth sensation and gastrointestinal disorders. Disturbances in olfactory, gustatory and trigeminal function were significantly related to medication use. Ageusia and burning mouth sensation were significantly more prevalent among smokers. Except from higher prevalence of ageusia among participants with hyposalivation with respect to SWS, no significant associations were found between salivary secretion rate and chemosensory or trigeminal disorders in the present study.Conclusions: The present study revealed that one-third of 65-year-old individuals had impaired smell and more than one-fourth had impaired taste function. The prevalence of dysgeusia and burning mouth sensation was very low. Reduced smell and taste perception were more common among men than women. Furthermore, some diseases and medications were associated with chemosensory and trigeminal disorders. Ageusia was associated with SWS hyposalivation. [ABSTRACT FROM AUTHOR]

Objective: To assess the knowledge, opinions and expectations of persons with and without obesity concerning personalised genotype-based nutrition.Design: Questions about nutrition, weight management and personalised genotype-based dietary recommendations were asked via standardised telephone-based interviews. Sociodemographic and anthropometric data were collected. The data were statistically weighted by age, gender, education, domicile and BMI.Setting: Germany.Participants: Representative sample of the German population (n 1003) randomly sampled via a scientific Random Digit dial method plus 354 adults with a BMI ≥ 30·0 kg/m2 to enlarge the sample.Results: Data of 1357 participants were analysed (51·1 % female, age: 50·5 ± 18·5 years, 15·9 % adults with a BMI ≥ 30·0 kg/m2). About 42 % or 19 % of the survey participants stated to know the terms personalised dietary recommendation or genotype-based dietary recommendation, respectively. Of those, 15·8 % indicated to have an experience with a personalised or genotype-based dietary recommendation. Almost 70 % of the survey participants believed that a genotype-based dietary recommendation is a reasonable measure for weight management. About 55 % of the survey participants pointed out that a genotype-based dietary recommendation is an effective concept in general. One-third of the survey participants (34·6 %) indicated to conceive the usage of a genotype-based dietary recommendation.Conclusion: Most of the survey participants did not know the term personalised or genotype-based dietary recommendation. One-third of the study participants are interested to use a genotype-based dietary recommendation. Therefore, more education of the public is necessary to properly help people making informed and serious decisions and assessing commercially available direct-to-consumer genetic tests. [ABSTRACT FROM AUTHOR]

Study Question: What is willingness, preference and decision-making about planning for the possibility of needing multiple cycles of IVF/ICSI treatment among patients consulting for a first or repeat stimulated IVF/ICSI cycle?Summary Answer: The majority of patients seem to value the opportunity to plan for multiple cycles of treatment while acknowledging both possible challenges and benefits of doing so and decisions that might need to be made in advance.What Is Known Already: Patients have strong intentions to do treatment to achieve pregnancy and approximately 48-54% continue treatment when confronted with a failed cycle, undergoing at least three complete cycles of treatment. However, there is inconsistency between this apparent willingness to do multiple cycles of treatment and the way treatment is currently planned on a cycle-by-cycle basis with patients.Study Design, Size, Duration: The study was of cross-sectional design, comprising a mixed-methods English online survey posted between November 2019 and March 2020. Eligibility criteria were being a patient who had had a consultation to start a stimulated cycle of IVF/ICSI for the first time or for a repeat stimulated cycle after an unsuccessful cycle in the eight weeks prior to survey completion. Individuals were also required to be aged 18 or older (upper age limit of 42 years for women) and able to respond in English. In total 881 clicked on the survey link, 118 did not consent, 41 were excluded after data screening, 57 did not meet the inclusion criteria, 331 started the survey but did not complete it, 28 had missing data on critical variables (e.g., age) and 306 completed the survey (40.1% completion, 57 men, 249 women).Participants/materials, Setting, Methods: Participants were allocated to either the willing or unwilling to plan for multiple cycles of treatment group based on their responses to three variables: willingness to plan for three complete cycles, whether they would choose to have another cycle of IVF and whether they would continue treatment after an unsuccessful cycle. Quantitative questions gathered data on preferences towards planning for multiple cycles (i.e., attitudes, subjective norms and perceived behavioural control), challenges, benefits of planning for multiple cycles, decisional conflict experienced and treatment decisions involved in planning for multiple cycles. Demographic, fertility and fertility treatment information were also collected. Qualitative questions gathered textual data on other perceived benefits and challenges of planning for multiple cycles and solutions to the challenges. Descriptive and inferential statistics were used on quantitative data. Thematic analysis (inductive coding) was performed on the textual data.Main Results and the Role Of Chance: Overall, 73.2% (n = 224) of participants had had a consultation to start a first cycle of IVF/ICSI. Participants were on average 33 years of age and had been trying to conceive for three years. A total of 63.07% (n = 193) were university educated. A total of 56% (n = 172) of participants were willing to plan for multiple cycles of IVF/ICSI in advance of treatment. Repeated measures ANOVA, t-tests and chi-square analysis showed the willing group to be significantly more likely to have been in a relationship for longer (p<.05), have higher education (p<.05) and be resident in the United Kingdom (p<.05). The willing group had positive attitudes towards planning for multiple cycles (p<.001) and stronger agreement with subjective norms (p<.001), perceived behavioural control (p<.001), benefits of planning for multiple cycles (p<.01) and felt able and attached more importance to making treatment decisions in advance of treatment (p<.05). Data saturation was achieved for the thematic analysis of textual data which revealed a total of four other challenges (e.g., less decisional freedom) and six other benefits (e.g., having a realistic view of treatment) to planning for multiple cycles. Qualitative analysis also revealed that most patients could anticipate and provide solutions for the nine challenges of planning for multiple cycles (e.g., using flexible working for the negative effect of treatment on work).Limitations, Reasons For Caution: Limitations included the outcome measure being willingness to plan for multiple cycles rather than actual multi-cycle planning behaviour. The unwilling group represented a heterogeneous group with possibly unknown motivational coherence (e.g., definitely against planning, ambivalent about planning). Other limitations included the cross-sectional nature of the survey and the recruitment source.Wider Implications Of the Findings: Treatment consultations about undergoing fertility treatment could re-frame treatment to be a multi-cycle process in line with patient's willingness, preference and decision-making. This multi-cycle approach could empower patients and clinicians to discuss treatment expectations realistically and formulate fully informed treatment plans that take account of the high likelihood of cycle failure in addition to the treatment decisions that may need to be made during treatment when a cycle fails. This multi-cycle approach could help us support patients in adhering to their treatment plans even when faced with challenges, and help ascertain the level of treatment engagement possible to achieve parenthood goals.Study Funding/competing Interest(s): This project is funded by an Investigator-Sponsor Non-interventional Study from Merck Serono Ltd (MS200059_0010). Professor Boivin reports personal fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, Ferring Pharmaceuticals A/S, grant from Merck Serono Ltd, outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app. Dr. Gameiro reports consultancy fees from Ferring Pharmaceuticals A/S, Access Fertility and SONA-Pharm LLC, and grants from Merck Serono Ltd. Dr. Harrison declares no conflicts of interest.Trial Registration Number: n/a. [ABSTRACT FROM AUTHOR]

Background: For the European Prospective Investigation into Cancer and Nutrition (EPIC) study Germany, a self-administered food frequency questionnaire (FFQ) was developed and tested for its relative validity and reproducibility in 1991/1992. Study participants were 92 potential cohort members. This paper reports results regarding retinol, carotenoids, tocopherols and ascorbic acid.Methods: Study participants were invited to the study centre in Heidelberg once a month over one year. At each visit, a 24 hour recall was obtained. The FFQ was filled in twice with a 6-month interval (FFQ1, FFQ2). In addition, a questionnaire on general consumption frequencies of 14 broad food groups was completed. This information was combined with estimates derived from FFQ2 and frequency-corrected food and nutrient intakes were calculated (FFQcorr). Blood specimens were taken in winter and summer 1992.Results: The intraclass correlation of the FFQ ranged from 0.65 to 0.67 for retinol, tocopherols, carotenoids, and ascorbic acid. Intake of carotenoids by FFQcorr showed de-attenuated Pearson correlation coefficients with blood values in the order of 0.37, and with recall data of 0.44. Respective correlations for retinol were 0.21 and 0.29, for tocopherols 0.18 and 0.52, and for ascorbic acid 0.36 and 0.69. Errors of FFQcorr and 24-hour diet recalls were not correlated.Conclusions: In general, it was demonstrated that the FFQ was able to rank participants into biologically meaningful categories of intake or blood concentrations for carotenoids and ascorbic acid, but misclassification was higher for tocopherol and retinol. [ABSTRACT FROM AUTHOR]

Background: For use in the German part of the European Prospective Investigation into Cancer and Nutrition (EPIC) a self-administered, optically readable food frequency questionnaire (FFQ) was developed to assess individuals' usual food and nutrient intake over the past year. The food list comprised 158 food items for which the typical portion size, the consumption frequency (1-6 times) and the time period (day, week, month, or year) were requested. This paper reports the results of the reproducibility and relative validity of nutrient intakes obtained by this instrument.Methods: The study was carried out from October 1991 to October 1992. During this period, 104 men and women, aged 35-64 years, completed a 24-hour recall once a month, and the FFQ in the middle and at the end of this study. A short questionnaire on global consumption patterns was used to adjust the food consumption frequency given in the FFQ.Results: Reproducibility correlations varied from 0.59 for saturated fat to 0.88 for alcohol, with most values falling between 0.60 and 0.70. Energy-adjustment decreased the observed correlations for all nutrients. Correlations between nutrient intake values from the 12-day average of dietary recalls and the FFQ corrected for food consumption frequency ranged from 0.42 for polyunsaturated fat to 0.88 for alcohol, followed by 0.65 for dietary fibres. After de-attenuation and energy-adjustment the range of correlations was somewhat wider (0.43-0.75, without alcohol). With regard to classification, on average, 36% of subjects fell into the same quintile, and 75% into within-one quintile when classified by the frequency-corrected FFQ compared to the quintiles based on recalled data.Conclusions: In summary, the newly developed FFQ showed fairly good reproducibility and relative validity for most evaluated nutrients. The between-subject variation of nutrients in the German cohort (including the participants from East Germany) is likely to be greater than that among the subjects of the pilot phase. A revised version of the FFQ corrected for food consumption frequency is used in the EPIC study. [ABSTRACT FROM AUTHOR]

Background: The theory and practice of ethics consultations (ECs) in health care are still characterized by many controversies, including, for example, the practice of giving recommendations. These controversies are complicated by an astonishing lack of evidence in the whole field. It is not clear how often a recommendation is issued in ethics consultations and when and why this step is taken. Especially in a facilitation model in which giving recommendations is optional, more data would be helpful to evaluate daily practice, ensure that this practice is in line with the overarching goals of this approach and support the development of standards.Methods: We analyzed all consultations requested from an EC service working under a facilitation approach at a maximum-care university hospital in Germany over a period of more than 10 years. Our aim was to better understand why-and under what circumstances-some consultation requests result in a recommendation, whereas others can be sufficiently addressed solely by facilitated meetings. We especially wanted to know when and why clients felt the need for clear advice from the EC service while in other cases they did not. We compared ethics consultations in terms of the differences between cases with and without recommendations issued by the ethics consultants using χ2 difference tests and Welch's t-test.Results: A total of 243 ECs were carried out between September 2008 and December 2019. In approximately half of the cases, a recommendation was given. All recommendations were issued upon the request of clients. When physicians asked for an EC, the consultation was significantly more likely to result in a recommendation than when the EC was requested by any other party. ECs in cases on wards with ethics rounds resulted in comparably fewer recommendations than those in wards without ethics rounds. When interpersonal conflicts were part of the problem or relatives were present in the meeting, clients less frequently asked for a recommendation.Conclusion: From the client's point of view, there does not seem to be only one "right" way to provide ethics consultations, but rather several. While facilitated meetings are obviously appreciated by clients, there also seem to be situations in which a recommendation is desired (especially by physicians). Further empirical and theoretical research is needed to validate our single-center results and re-evaluate the role of recommendations in ethics consultations. [ABSTRACT FROM AUTHOR]

Study Question: Can the Endometriosis Fertility Index (EFI) be estimated accurately before surgery?Summary Answer: The EFI can be estimated accurately based on mere clinical/ultrasound information, with some improvement after adding data from diagnostic laparoscopy.What Is Known Already: The EFI is a validated clinical instrument predicting the probability of pregnancy after endometriosis surgery without the use of ART. Being an end-of-surgery-score, it implies the decision for operative laparoscopy to be made in advance-hence, its role in the pre-surgical decision-making process remains to be established.Study Design, Size, Duration: Single-cohort prospective observational study in 82 patients undergoing complete endometriosis excision (between June and December 2016). Two methods were used to estimate the final EFI: type A based on non-surgical clinical/ultrasound findings only, and type B based on the combination of non-surgical clinical/ultrasound findings and diagnostic laparoscopy data. To calculate EFI type A, an algorithm was created to translate non-surgical clinical/imaging information into rASRM (revised American Society of Reproductive Medicine)-and EFI points. EFI type A and type B estimates were assessed for their clinical and numerical agreement with the final EFI score. Agreement was defined as clinical if EFI scores were within the same range (0-4, 5-6, 7-10), and numerical if their difference was ≤1.Participants/materials, Setting, Methods: All 82 patients underwent complete laparoscopic CO2-laser excision of any rASRM stage of endometriosis in the Leuven University Fertility Centre (LUFC) of University Hospitals Leuven, a tertiary referral centre for both endometriosis and infertility. An anonymized clinical research file was created. For each patient, three different data sets were created, in order to allow the estimation of the (surgical part) EFI and of the rASRM scores, defined as follows: 'Estimated type A' contained only non-surgical clinical/imaging data, 'Estimated type B' included type A information plus the information of the diagnostic laparoscopy and 'Final EFI' included information of type A, type B and all intra-operative information required to calculate the final EFI. To calculate EFI type A without surgical information, a set of rules was used to translate pre-surgical clinical/imaging information into (rASRM and EFI points). Scoring was done by one person (C.T.), with a time interval of 4 weeks between sessions for each EFI type. Next to the EFI, also rASRM score and stage were calculated.Main Results and the Role Of Chance: Agreement rate between estimated EFI type A and final EFI was high for both the clinical (0.915; 95% CI 0.832-0.965) and numerical definition (0.878; 95% CI 0.787-0.940). Agreement rates between estimated EFI type B and final EFI were even higher (clinical (0.988; 95% CI 0.934-1.000), numerical (0.963; 95% CI 0.897-0.992)).Limitations, Reasons For Caution: Type A estimation is dependent on high-level gynaecological ultrasound expertise, which may not be available in all clinics. A small number of patients had no prior clinical, ultrasound (hard markers) or surgical confirmation of the diagnosis of endometriosis. When applying the estimated EFI type A in clinical practice, a priori assumptions of the presence or absence of endometriosis will need to be made in adjunct to the estimation of the estimated type A EFI when counselling patients on the potential benefit of an (at least diagnostic) laparoscopy. The level of agreement for type A or B should also be taken into account when counselling patients on the type of efforts undertaken to attempt to diagnose or rule out endometriosis.Wider Implications Of the Findings: As this study reports, the EFI can be estimated accurately based on clinical/ultrasound data only without the need for any surgical data. This means that the EFI could be used as an instrument to guide joint physician-patient decision-making between surgery, ART or other fertility management options for the individualized treatment of women with endometriosis-related infertility.Study Funding/competing Interest(s): During this study period, C.T. was supported by FWO (Research Fund Flanders, Grant number 1700816N) and UZ Leuven KOF (University Hospitals Leuven, Klinisch Onderzoeksfonds).The LUFC received unrestricted research grants from Ferring Pharmaceuticals and Merck SA. Gedeon Richter and MSD sponsored travel to and attendance at scientific meetings. C.M. received consultancy fees from Lumenis (paid to KU Leuven, no private revenue). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since 1 October 2015. He continues his academic appointment on a part-time basis as Professor of Reproductive Medicine at the University of Leuven (KU Leuven). T.D. has been vice-president and head of global medical affairs infertility for the multinational pharmaceutical company Merck (Darmstadt, Germany) since October 2015. He is also a Guest Professor in Reproductive Medicine and Biology at the Department of Development and Regeneration, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium, and an Adjunct Professor at the Department of Obstetrics and Gynecology in the University of Yale, New Haven, USA. This work was initiated before he joined Merck KGaA in October 2015, and completed during the subsequent years.Trial Registration Number: study registration number at UZ Leuven Clinical Trial Centre: S59221. [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: Qualitative methods offer a unique contribution to health research. Academic dissertations in the medical field provide an opportunity to explore research practice. Our aim was to assess the use of qualitative methods in dissertations in the medical field.Methods: By means of a methodological observational study, an analysis of all academic medical dissertations' abstracts between 1998 and 2018 in a repository databank of a large medical university faculty in Germany was performed. This included MD dissertations (Dr. med. (dent.)) and medical science dissertations (Dr. sc. hum.). All abstracts including "qualitativ*" were screened for studies using qualitative research methods. Data were extracted from abstracts using a category grid considering a) general characteristics (year, language, degree type), b) discipline, c) study design (mixed methods/qualitative only, data conduction, data analysis), d) sample (size and participants) and e) technologies used (data analysis software and recording technology). Thereby reporting quality was assessed.Results: In total, 103 abstracts of medical dissertations between 1998 and 2018 (1.4% of N = 7619) were included, 60 of MD dissertations and 43 of medical sciences dissertations. Half of the abstracts (n = 51) referred to dissertations submitted since 2014. Most abstracts related to public health/hygiene (n = 27) and general practice (n = 26), followed by medical psychology (n = 19). About half of the studies (n = 47) used qualitative research methods exclusively, the other half (n = 56) used mixed methods. For data collection, primarily individual interviews were used (n = 80), followed by group interviews (n = 33) and direct observation (n = 11). Patients (n = 36), physicians (n = 36) and healthcare professionals (n = 17) were the most frequent research participants. Incomplete reporting of participants and data analysis was common (n = 67). Nearly half of the abstracts (n = 46) lacked information on how data was analysed, most of the remaining (n = 43) used some form of content analysis. In summary, 36 abstracts provided all crucial data (participants, sample size,; data collection and analysis method).Conclusion: A small number of academic dissertations used qualitative research methods. About a third of these reported all key aspects of the methods used in the abstracts. Further research on the quality of choice and reporting of methods for qualitative research in dissertations is recommended. [ABSTRACT FROM AUTHOR]

Background: In an effort to contain the effects of the coronavirus disease (COVID-19) pandemic, health care systems worldwide implemented telemedical solutions to overcome staffing, technical, and infrastructural limitations. In Germany, a multitude of telemedical systems are already being used, while new approaches are rapidly being developed in response to the crisis. However, the extent of the current implementation within different health care settings, the user's acceptance and perception, as well as the hindering technical and regulatory obstacles remain unclear.Objective: The aim of this paper is to assess the current status quo of the availability and routine use of telemedical solutions, user acceptance, and the subjectively perceived burdens on telemedical approaches. Furthermore, we seek to assess the perception of public information quality among professional groups and their preferred communication channels.Methods: A national online survey was conducted on 14 consecutive days in March and April 2020, and distributed to doctors, nurses, and other medical professionals in the German language.Results: A total of 2827 medical professionals participated in the study. Doctors accounted for 65.6% (n=1855) of the professionals, 29.5% (n=833) were nursing staff, and 4.9% (n=139) were identified as others such as therapeutic staff. A majority of participants rated the significance of telemedicine within the crisis as high (1065/2730, 39%) or neutral (n=720, 26.4%); however, there were significant differences between doctors and nurses (P=.01) as well as between the stationary sector compared to the ambulatory sector (P<.001). Telemedicine was already in routine use for 19.6% (532/2711) of German health care providers and in partial use for 40.2% (n=1090). Participants working in private practices (239/594, 40.2%) or private clinics (23/59, 39.0%) experienced less regulatory or technical obstacles compared to university hospitals (586/1190, 49.2%). A majority of doctors rated the public information quality on COVID-19 as good (942/1855, 50.8%) or very good (213/1855, 11.5%); nurses rated the quality of public information significantly lower (P<.001). Participant's age negatively correlated with the perception of telemedicine's significance (ρ=-0.23; P<.001).Conclusions: Telemedicine has a broad acceptance among German medical professionals. However, to establish telemedical structures within routine care, technical and regulatory burdens must be overcome. [ABSTRACT FROM AUTHOR]

Objective: The obesity pandemic is an increasing burden for society. Information on key drivers of the nutrition cycle of (a) social causation, (b) biological causation and (c) health selection is vital for effective policies targeted at the reduction of obesity prevalence. However, empirical causal knowledge on (a) the social predictors of diet quality, (b) its impact on corpulence and (c) the socioeconomic consequences of obesity is sparse. We overcome the limitations of previous research and acquire comprehensive causal insight into this cycle.Design: Therefore, we analyse two German socio-epidemiological panel surveys exploiting their longitudinal panel structure utilising hybrid panel regression models.Setting: General population of Germany.Participants: German Health Interview and Examination Survey for Children and Adolescents (KiGGS, n 17 640; age 0-24 years) and the German National Nutrition Monitoring (NEMONIT, n 2610; age 15-82 years).Results: The results indicate that (a) interestingly only sex, education and age explain healthy diets; (b) increases in a newly developed Optimised Healthy Eating Index (O-HEI-NVSII) and in nuts intake reduce BMI, while growing overall energy intake, lemonade, beer and meat (products) intake drive corpulence; (c) in turn, developing obesity decreases socioeconomic status.Conclusions: These results suggest that policies targeted at the reduction of obesity prevalence may be well advised to focus on boys and men, people with low education, the promotion of a healthy diet and nuts intake, and the limitation of lemonade, beer and meat (products) intake. Therefore, future research may focus on the replication of our findings utilising longer panels and experimental approaches. [ABSTRACT FROM AUTHOR]

Background: Cancer-related fatigue represents one major cause of reduced quality of life in cancer patients and can seriously affect the physical, emotional, and cognitive functioning impeding coping with the disease. Options for effective treatment of cancer-related fatigue are limited, consisting only of non-pharmacologic interventions like physical activity, psychosocial, and mind-body interventions. Recent evidence suggests that vitamin D3 supplementation might alleviate cancer-related fatigue. However, confirmation in a randomized controlled trial is needed.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 456 colorectal cancer (CRC) patients aged 18 years and older are being recruited in three German rehabilitation clinics. Study inclusion requires hospitalization of at least 3 weeks at such a clinic, a diagnosis of non-metastatic CRC (stage I-III), surgical removal of the tumor within the past 9 months, and season-adapted vitamin D insufficiency or deficiency. Eligible patients are randomly assigned to a personalized regimen of vitamin D3 or placebo for 12 weeks. In the intervention group, a loading dose of 20,000 or 40,000 IU vitamin D3 will be administered daily during the first 11 days, followed by a maintenance dose of 2000 IU daily. Patients will complete questionnaires for secondary outcomes (fatigue subdomains, quality of life and subdomains, depression, functional well-being, and infection frequency). Blood and urine samples will be collected for analyses of safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, and renal impairment) and efficacy biomarkers (25-hydroxyvitamin D, HbA1c, white blood cell count, leukocyte subtype counts, serum C-reactive protein, uric acid, creatinine, triglycerides, total, low- and high-density lipoprotein cholesterol).Discussion: This trial tests whether a personalized vitamin D3 dosing regimen reduces or prevents fatigue among non-metastatic CRC patients by treating the underlying vitamin D deficiency/insufficiency. If efficacy can be confirmed, personalized vitamin D3 supplementation could be used as a tertiary prevention measure in addition to non-pharmacological treatments of cancer-related fatigue in CRC patients. We expect to detect an effect of vitamin D3 supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.Trial Registration: European Clinical Trials Database: EudraCT-No: 2019-000502-30, January 21, 2019; German Clinical Trials Register (DRKS): DRKS00019907 , April 30, 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: Low response rates do not indicate poor representativeness of study populations if non-response occurs completely at random. A non-response analysis can help to investigate whether non-response is a potential source for bias within a study.Methods: A cross-sectional survey among a random sample of a health insurance population with diabetes (n = 3642, 58.9% male, mean age 65.7 years), assessing depression in diabetes, was conducted in 2013 in Germany. Health insurance data were available for responders and non-responders to assess non-response bias. The response rate was 51.1%. Odds ratios (ORs) for responses to the survey were calculated using logistic regression taking into consideration the depression diagnosis as well as age, sex, antihyperglycaemic medication, medication utilization, hospital admission and other comorbidities (from health insurance data).Results: Responders and non-responders did not differ in the depression diagnosis [OR 0.99, confidence interval (CI) 0.82-1.2]. Regardless of age and sex, treatment with insulin only (OR 1.73, CI 1.36-2.21), treatment with oral antihyperglycaemic drugs (OAD) only (OR 1.77, CI 1.49-2.09), treatment with both insulin and OAD (OR 1.91, CI 1.51-2.43) and higher general medication utilization (1.29, 1.10-1.51) were associated with responding to the survey.Conclusion: We found differences in age, sex, diabetes treatment and medication utilization between responders and non-responders, which might bias the results. However, responders and non-responders did not differ in their depression status, which is the focus of the DiaDec study. Our analysis may serve as an example for conducting non-response analyses using health insurance data. [ABSTRACT FROM AUTHOR]

Background: Information regarding the prevalence of infectious diseases (IDs) in child and adolescent refugees in Europe is scarce. Here, we evaluate a standardized ID screening protocol in a cohort of unaccompanied refugee minors (URMs) in a municipal region of southwest Germany.Methods and Findings: From January 2016 to December 2017, we employed a structured questionnaire to screen a cohort of 890 URMs. Collecting sociodemographic information and medical history, we also performed a standardized diagnostics panel, including complete blood count, urine status, microbial stool testing, tuberculosis (TB) screening, and serologies for hepatitis B virus (HBV) and human immunodeficiency virus (HIV). The mean age was 16.2 years; 94.0% were male, and 93.6% originated from an African country. The most common health complaints were dental problems (66.0%). The single most frequent ID was scabies (14.2%). Of the 776 URMs originating from high-prevalence countries, 7.7% and 0.4% tested positive for HBV and HIV, respectively. Nineteen pathogens were detected in a total of 119 stool samples (16.0% positivity), with intestinal schistosomiasis being the most frequent pathogen (6.7%). Blood eosinophilia proved to be a nonspecific criterion for the detection of parasitic infections. Active pulmonary TB was identified in 1.7% of URMs screened. Of note, clinical warning symptoms (fever, cough >2 weeks, and weight loss) were insensitive parameters for the identification of patients with active TB. Study limitations include the possibility of an incomplete eosinophilia workup (as no parasite serologies or malaria diagnostics were performed), as well as the inherent selection bias in our cohort because refugee populations differ across Europe.Conclusions: Our study found that standardized ID screening in a URM cohort was practicable and helped collection of relevant patient data in a thorough and time-effective manner. However, screening practices need to be ameliorated, especially in relation to testing for parasitic infections. Most importantly, we found that only a minority of infections were able to be detected clinically. This underscores the importance of active surveillance of IDs among refugees. [ABSTRACT FROM AUTHOR]

Background: Tobacco smoking is one of the most important risk factors of coronary heart disease (CHD). Hence, smoking cessation is considered pivotal in the prevention of CHD. The current study aimed to evaluate smoking cessation patterns and determine factors associated with smoking cessation in patients with established CHD.Methods: The fourth European Survey of Cardiovascular Disease Prevention and Diabetes investigated quality of CHD care in 24 countries across Europe in 2012/13. In the German subset, smoking cessation patterns and clinical characteristics were repetitively assessed a) during index event due to CHD by medical record abstraction, b) as part of a face-to-face interview 6 to 36 months after the index event (i.e. baseline visit), and c) by telephone-based follow-up interview two years after the baseline visit. Logistic regression analysis was performed to search for factors determining smoking status at the time of the telephone interview.Results: Out of 469 participants available for follow-up, 104 (22.2%) had been classified as current smokers at the index event. Of those, 65 patients (62.5%) had quit smoking at the time of the telephone interview, i.e., after a median observation period of 3.5 years (quartiles 3.0, 4.1). Depressed mood at baseline visit and higher education level were less prevalent amongst quitters vs non-quitters (17.2% vs 35.9%, p = 0.03 and 15.4% vs 33.3%, p = 0.03), cardiac rehabilitation programs were more frequently attended by quitters (83.1% vs 48.7%, p < 0.001), and there was a trend for a higher prevalence of diabetes at baseline visit in quitters (37.5% vs 20.5%, p = 0.07). In the final multivariable model, cardiac rehabilitation was associated with smoking cessation (OR 5.19; 95%CI 1.87 to 14.46; p = 0.002).Discussion: Attending a cardiac rehabilitation program after a cardiovascular event was associated with smoking cessation supporting its use as a platform for smoking cessation counseling and relapse prevention. [ABSTRACT FROM AUTHOR]

Background: The ICD-11 includes a new disorder, complex post-traumatic stress disorder (CPTSD). A network approach to CPTSD will enable investigation of the structure of the disorder at the symptom level, which may inform the development of treatments that target specific symptoms to accelerate clinical outcomes.AimsWe aimed to test whether similar networks of ICD-11 CPTSD replicate across culturally different samples and to investigate possible differences, using a network analysis.Method: We investigated the network models of four nationally representative, community-based cross-sectional samples drawn from Germany, Israel, the UK, and the USA (total N = 6417). CPTSD symptoms were assessed with the International Trauma Questionnaire in all samples. Only those participants who reported significant functional impairment by CPTSD symptoms were included (N = 1591 included in analysis; mean age 43.55 years, s.d. 15.10, range 14-99, 67.7% women). Regularised partial correlation networks were estimated for each sample and the resulting networks were compared.Results: Despite differences in traumatic experiences, symptom severity and symptom profiles, the networks were very similar across the four countries. The symptoms within dimensions were strongly associated with each other in all networks, except for the two symptom indicators assessing aspects of affective dysregulation. The most central symptoms were 'feelings of worthlessness' and 'exaggerated startle response'.Conclusions: The structure of CPTSD symptoms appears very similar across countries. Addressing symptoms with the strongest associations in the network, such as negative self-worth and startle reactivity, will likely result in rapid treatment response.Declaration of interestA.M. and M.C. were members of the World Health Organization (WHO) ICD-11 Working Group on the Classification of Disorders Specifically Associated with Stress, reporting to the WHO International Advisory Group for the Revision of ICD-10 Mental and Behavioural Disorders. The views expressed in this article are those of the authors and do not represent the official policies or positions of the International Advisory Group or the WHO. [ABSTRACT FROM AUTHOR]

We estimated numbers of hospitalizations for norovirus gastroenteritis (NGE) and associated medical costs in Germany, where norovirus testing is high because reimbursement is affected. We extracted aggregate data for patients hospitalized with a primary or secondary code from the International Classification of Diseases, 10th Revision (ICD-10), NGE diagnosis during 2007-2012 from the German Federal Statistics Office. We assessed reliability of the coding system in patient records from a large academic hospital. Approximately 53,000-90,000 NGE hospitalizations occurred annually in Germany (21,000-33,000 with primary and 32,000-57,000 with secondary ICD-10-coded NGE diagnoses). Rates of hospitalization with NGE as primary diagnosis were highest in children <2 years of age; rates of hospitalization with NGE as secondary diagnosis were highest in adults >85 years of age. The average annual reimbursed direct medical cost of NGE hospitalizations was €31-43 million. Among patients with a NGE ICD-10 code, 87.6% had positive norovirus laboratory results. [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: Key recommendations for the management of patients with polypharmacy are structured medication counselling (SMC), medication lists and systematic medication reviews.Objective: The aim of this study was to identify determinants (hindering and facilitating factors) for the implementation of the recommendations in general practice.Methods: This study was linked to a tailored intervention aimed at improving the implementation of the recommendations in German general practice. Interviews and focus groups with different healthcare professionals were carried out in the design phase and after delivery of the intervention. The material from both data collections was analysed separately in a content analytical approach resulting in two sets of categories. For this study, the subcategories of both sets were assigned to the Tailoring Interventions for Chronic Diseases (TICD) checklist, a comprehensive framework of determinants of practice.Results: Interviews with 24 general practitioners (GPs), 4 other medical specialists, 1 pharmacist, 3 nurses and 6 medical assistants as well as 2 mixed focus groups with 17 professionals were conducted. We identified 93 determinants: 29 referred to medication counselling, 21 to the use of medication lists, 20 to medications reviews and 23 to all recommendations. The determinants were related to all 7 main domains and to 25 of the 57 subdomains on the TICD checklist including guideline factors, patient factors, individual healthcare professional factors, social, political and legal factors, incentives and resources, and capacity for organizational change.Conclusion: While many interventions to improve polypharmacy focus on the provision of pharmacological knowledge, a much wider range of domains need to be addressed, such as communication skills, patient involvement and practice organization. [ABSTRACT FROM AUTHOR]

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

Background: There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding and thromboembolic complications.Methods: We conducted a single-centre study in patients undergoing left atrial ablation of AF. Three groups were defined: 1) bridging: interrupted vitamin-K-antagonists (VKA), INR ≤2, and bridging with heparin; 2) VKA: uninterrupted VKA and INR of > 2; 3) DOAC: uninterrupted direct oral anticoagulants. Bleeding complications, thromboembolic events and peri-procedural heparin doses were assessed.Results: In total, 780 patients were documented. At 48 h, major complications were more common in the bridging group compared to uninterrupted VKA and DOAC groups (OR: 3.42, 95% CI: 1.29-9.10 and OR: 3.01, 95% CI: 1.19-7.61), largely driven by differences in major pericardial effusion (OR: 4.86, 95% CI: 1.56-15.99 and OR: 4.466, 95% CI, 1.52-13.67) and major vascular events (OR: 2.92, 95% CI: 0.58-14.67 and OR: 9.72, 95% CI: 1.00-94.43). Uninterrupted VKAs and DOACs resulted in similar odds of major complications (overall OR: 1.14, 95% CI: 0.44-2.92), including cerebrovascular events (OR: 1.21, 95% CI: 0.27-5.45). However, whereas only TIAs were observed in DOAC and bridging groups, strokes also occurred in the VKA group. Rates of minor complications (pericardial effusion, vascular complications, gastrointestinal hemorrhage) and major/minor groin hemorrhage were similar across groups.Conclusion: Our dataset illustrates that uninterrupted VKA and DOAC have a better risk-benefit profile than VKA bridging. Bridging was associated with a 4.5× increased risk of complications and should be avoided, if possible. [ABSTRACT FROM AUTHOR]

Objectives: To explore effects of disease prevalence adjustment on ambulatory care-sensitive hospitalization (ACSH) rates used for quality comparisons.Data Sources/study Setting: County-level hospital administrative data on adults discharged from German hospitals in 2011 and prevalence estimates based on administrative ambulatory diagnosis data were used.Study Design: A retrospective cross-sectional study using in- and outpatient secondary data was performed.Data Collection: Hospitalization data for hypertension, diabetes, heart failure, chronic obstructive pulmonary disease, and asthma were obtained from the German Diagnosis Related Groups (DRG) database. Prevalence estimates were obtained from the German Central Research Institute of Ambulatory Health Care.Principal Findings: Crude hospitalization rates varied substantially across counties (coefficients of variation [CV] 28-37 percent across conditions); this variation was reduced by prevalence adjustment (CV 21-28 percent). Prevalence explained 40-50 percent of the observed variation (r = 0.65-0.70) in ACSH rates for all conditions except asthma (r = 0.07). Between 30 percent and 38 percent of areas moved into or outside condition-specific control limits with prevalence adjustment.Conclusions: Unadjusted ACSH rates should be used with caution for high-stakes public reporting as differences in prevalence may have a marked impact. Prevalence adjustment should be considered in models analyzing ACSH. [ABSTRACT FROM AUTHOR]

Objective: Little attention has been given to psychological factors as correlates of health care use, which could be an important key to manage it. We analyzed the association of psychological factors with health care use.Data Sources: Primary data were obtained from three follow-ups (2002, 2008, and 2011) of a large population-based study with participants aged 40+.Study Design: Using a longitudinal observational study, we analyzed the psychological factors of negative and positive affect (affective well-being), life satisfaction (cognitive well-being), self-efficacy, loneliness, self-esteem, optimism, and flexible goal adjustment using fixed-effects regressions.Data Collection: The participants provided data on health care use (visits to general practitioners [GPs] and specialists as well as hospitalization) and psychological factors via self-administered questionnaires and personal interviews (7,116 observations). The sample was drawn using national probability sampling.Principal Findings: Controlling for self-rated health, chronic diseases and sociodemographics, increases in affective well-being, and optimism decreased health care use of GPs, specialists, and hospital treatment. Increases in cognitive well-being decreased health care use of GPs and specialists. Increases in self-efficacy decreased hospitalization.Conclusions: The study underlines the influence of psychological factors on health care use. Thus, whenever possible, future studies of health care use should include psychological factors, and efforts to reduce health care use might focus on such factors. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a combination of Internet-based and postal survey methods (mixed-mode) compared to postal-only survey methods (postal-only) leads to improved response rates in a physician survey, and to compare the cost implications of the different recruitment strategies.Data Sources/study Setting: All primary care gynecologists in Bremen and Lower Saxony, Germany, were invited to participate in a cross-sectional survey from January to July 2014.Study Design: The sample was divided into two strata (A; B) depending on availability of an email address. Within each stratum, potential participants were randomly assigned to mixed-mode or postal-only group.Principal Findings: In Stratum A, the mixed-mode group had a lower response rate compared to the postal-only group (12.5 vs. 20.2 percent; RR = 0.61, 95 percent CI: 0.44-0.87). In stratum B, no significant differences were found (15.6 vs. 16.2 percent; RR = 0.95, 95 percent CI: 0.62-1.44). Total costs (in €) per valid questionnaire returned (Stratum A: 399.72 vs. 248.85; Stratum B: 496.37 vs. 455.15) and per percentage point of response (Stratum A: 1,379.02 vs. 861.02; Stratum B 1,116.82 vs. 1,024.09) were higher, whereas variable costs were lower in mixed-mode compared to the respective postal-only groups (Stratum A cost ratio: 0.47, Stratum B cost ratio: 0.71).Conclusions: In this study, primary care gynecologists were more likely to participate by traditional postal-only than by mixed-mode survey methods that first offered an Internet option. However, the lower response rate for the mixed-mode method may be partly due to the older age structure of the responding gynecologists. Variable costs per returned questionnaire were substantially lower in mixed-mode groups and indicate the potential for cost savings if the sample population is sufficiently large. [ABSTRACT FROM AUTHOR]

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

Objective: Evaluating the potential of the high-dimensional propensity score (HDPS) to control for residual confounding in studies analyzing quality of care based on administrative health insurance data.Data Source: Secondary data from 2004 to 2009 from three German statutory health insurance providers.Study Design: We conducted a retrospective cohort study in patients with elective percutaneous coronary interventions (PCIs) and compared the mortality risk between the in- and outpatient setting using Cox regression. Adjustment for predefined confounders was performed using conventional propensity score (PS) techniques. Further, an HDPS was calculated based on predefined and empirically selected confounders from the database.Principal Findings: Conventional PS methods showed a decreased mortality risk for outpatient compared to inpatient PCIs, while trimming of patients with nonoverlap in the HDPS distribution and weighting resulted in a comparable risk. Most comorbidities were less prevalent in the HDPS-trimmed population compared to the original one.Conclusion: The HDPS methodology may reduce residual confounding by rendering the studied cohort more comparable through restriction. However, results cannot be generalized for the entire study population. To provide unbiased results, full assessment of all unmeasured confounders from proxy information in the database would be necessary. [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: 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]

Background/objectives: Assessing fatty acid (FA) composition in relation to inflammatory markers can shed light on the role of different FA and their metabolism in low-grade inflammation. Existing exploratory studies in children are scarce, and findings inconsistent. We hence aim to analyse associations of FA with common inflammatory markers, high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6), in 10-year-old children.Subjects/methods: Complete data were available for 958 participants from the 10-year follow-up of the LISAplus (Influence of Lifestyle-Related Factors on the Immune System and the Development of Allergies in Childhood plus the Influence of Traffic Emissions and Genetics) birth cohort study. FA composition was assessed in serum glycerophospholipids. Hs-CRP and IL-6 were categorised into three levels. Associations of FA with inflammatory markers were assessed using multinomial logistic regression, adjusting for potential confounders. Additionally, sex-stratified analyses were carried out.Results: FA exposures associated with significantly higher low-grade inflammation, as indicated by higher hs-CRP or IL-6 levels, included: palmitic acid (PA) (IL-6: P<0.001, 95% confidence interval: 1.30; 2.43), arachidonic acid (AA) (hs-CRP: P=0.002, 1.07; 1.31), n-6 highly unsaturated FA (HUFA) (hs-CRP: P=0.002, 1.06; 1.27), ratio of AA to linoleic acid (AA/LA) (hs-CRP: P<0.001, 1.16; 1.62) and total saturated FA (SFA) (IL-6: P<0.001, 1.77; 3.15). FA exposures associated with reduced levels of inflammatory markers included LA (hs-CRP: P=0.001, 0.84; 0.96; IL-6: P<0.001, 0.69; 0.90) and total polyunsaturated FA (PUFA) (IL-6: P<0.001, 0.57; 0.78).Conclusions: These findings suggest that higher SFA and minor n-6 HUFA, namely PA and AA, are associated with increased low-grade inflammation in children, whereas the major dietary n-6 PUFA and total PUFA are associated with reduced inflammation. Elevated desaturase activity, estimated by the ratio AA/LA, may be associated with higher inflammation, particularly in boys. [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]

Background: Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain.Methods/design: This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints.Discussion: We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas.Trial Registration: German Clinical Trials Register (DRKS), ID: DRKS00010009 . Registered on 11 May 2016. [ABSTRACT FROM AUTHOR]

Background: Pulmonary rehabilitation programs often fail to substantially enhance long-term physical activity in patients with chronic obstructive pulmonary disease (COPD). The reasons for successful physical activity changes in patients with COPD are not well understood. The need to better understand the determinants of physical activity in patients with COPD and effective rehabilitation strategies to improve physical activity is evident.Methods/design: The STAR study (Stay Active after Rehabilitation) investigates, in a randomized controlled trial, the additional effect of a pedometer-based behavior-change intervention during inpatient pulmonary rehabilitation on objectively measured physical activity 6 weeks and 6 months post rehabilitation. The intervention uses the behavior-change techniques (1) instruction on how, where and when to perform the behavior, (2) prompt goal setting for physical activity, (3) prompt self-monitoring of behavior, and (4) feedback on behavior. The primary outcome of physical activity will be measured using a physical activity monitor (Actigraph wGT3X-BT) for a period of 7 days, firstly 2 weeks before rehabilitation begins (t0) as well as 6 weeks and 6 months after rehabilitation (t3, t4). Additionally, to predict physical activity progression after rehabilitation, a complex personal diagnostics battery, including questionnaires as well as functional assessments, is to be carried out at the start and end of rehabilitation (t1, t2). This battery is based on the foundational ideas of the Physical Activity-Related health Competence model. Five hundred and two patients with COPD, aged 18 years or older and admitted for an approved pulmonary rehabilitation, will be enrolled in the STAR study.Discussion: The STAR study is designed as a randomized controlled trial to gain a better understanding of the personal determinants of physical activity in patients with COPD and to evaluate a pedometer-based physical activity-change intervention in the context of inpatient pulmonary rehabilitation. The results enable the future identification of patients with COPD who will find it difficult to engage in long-term physical activity after rehabilitation. Based on this, intervention strategies to promote physical activity in the content of pulmonary rehabilitation can be optimized.Trial Registration: Clinicaltrials.gov, ID: NCT02966561 . Registered retrospectively after the start of the recruitment in June 2016 on 22 November 2016. All protocol modifications will be registered in the trial registry. [ABSTRACT FROM AUTHOR]

Background: Follow-up care after kidney transplantation is performed in transplant centers as well as in local nephrologist's practices in Germany. However, organized integrated care of these different sectors of the German health care system is missing. This organizational deficit as well as non-adherence of kidney recipients and longterm cardiovascular complications are major reasons for an impaired patient and graft survival.Methods: The KTx360° study is supported by a grant from the Federal Joint Committee of the Federal Republic of Germany. The study will include 448 (39 children) incident patients of all ages with KTx after study start in May 2017 and 963 (83 children) prevalent patients with KTx between 2010 and 2016. The collaboration between transplant centers and nephrologists in private local practices will be supported by internet-based case-files and scheduled virtual visits (patient consultation via video conferencing). At specified points of the care process patients will receive cardiovascular and adherence assessments and respective interventions. Care will be coordinated by an additional case management. The goals of the study will be evaluated by an independent institute using claims data from the statutory health insurances and data collected from patients and their caregivers during study participation. To model longitudinal changes after transplantation and differences in changes and levels of immunosuppresive therapy after transplantation between study participants and historical data as well as data from control patients who do not participate in KTx360°, adjusted regression analyses, such as mixed models with repeated measures, will be used. Relevant confounders will be controlled in all analyses.Discussion: The study aims to prolong patient and graft survival, to reduce avoidable hospitalizations, co-morbidities and health care costs, and to enhance quality of life of patients after kidney transplantation.Trial Registration: ISRCTN29416382 (retrospectively registered on 05.05.2017). [ABSTRACT FROM AUTHOR]

Background: It is the wish of both people with cognitive impairment and their informal caregivers for the impaired person to live at home for as long as possible. This is also in line with economic arguments about health. The existing structure of day-care services for the elderly can be used to achieve this. Due to the current lack of empirical evidence in this field, most day-care centres do not offer a scientifically evaluated, structured intervention, but instead offer a mixture of individual activities whose efficacy has not yet been established. Informal caregivers of people with dementia use day-care centres primarily to relieve themselves of their care tasks and as a support service.Methods/design: The present study therefore investigates the effectiveness of a combination of a multicomponent activation therapy for people with mild cognitive impairment (MCI) or mild to moderate dementia at day-care centres and a brief telephone intervention for their informal caregivers. The study is conducted as a cluster-randomised intervention trial at 34 day-care centres in Germany with a 6-month treatment phase. The centres in the waitlist control group provide "care as usual". A power analysis indicated that 346 people should initially be included in the study. The primary endpoints of the study include the ability to perform activities of daily living (ADL) and cognitive capacities on the side of the day-care centre users and the subjectively perceived burden and well-being of the informal caregivers. The total duration of the study is 3 years, during which data are collected both by the psychometric testing of the people with cognitive impairment and by telephone interviews with informal caregivers.Discussion: The project has three distinctive quality features. First, it is embedded in real care situations since the day-care services have already been established for this target group. Second, due to the large number of cases and the fact that the participating day-care centres are spread across the entire country, the results can be expected to be generalisable. Third, the interventions can be assumed to be implementable as they required only a one-day training event for the staff already working at the centres.Trial Registration: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively). [ABSTRACT FROM AUTHOR]

Background: The prevention of overweight and obesity during infancy is a highly relevant public health topic given the significant impact of childhood obesity on acute and chronic diseases, general health, and well-being in later stages of life. Apart from the family setting, daycare facilities (DFs) represent a key setting for health promotion among children under the age of six years. "JolinchenKids - Fit and Healthy in Daycare" is a multi-component program promoting physical activity (PA), healthy eating, and mental well-being in 3- to 6-year-old preschoolers at DFs, originally designed by the German health insurance AOK. To evaluate program effectiveness, a cluster-controlled trial involving 68 DFs is currently conducted. The objective of this article is to describe the background, study design, and aims of this trial.Methods/design: Sixty-eight DFs across Germany will be recruited to take part in the study, half of them serving as intervention DFs and half of them as delayed intervention control DFs (which receive the program upon completion of the study). At each DF, height, weight, and body composition, as well as motor skills, will be assessed in twenty 3- to 6-year-old children. Children's eating and PA habits, and mental well-being will be assessed via parental questionnaires. A subsample of children (i.e., at 24 DFs which are randomly selected within a geographic region) will be asked to wear accelerometers at their wrists to objectively measure PA over the course of seven days. To compare changes in body composition, motor skills, eating and PA habits, and mental well-being of children at intervention DFs with those observed among children at delayed intervention control DFs over one year, all measurements will take place at baseline and twelve months after the launch of the program at all DFs.Discussion: This study investigates the influence of a health promotion program in the daycare setting on various outcomes, including body composition and objectively measured PA, in a nationwide sample of 3- to 6-year-old preschoolers. This study will provide evidence regarding the effectiveness of a multi-component program for health promotion in this setting and may provide insights into new strategies for preventing obesity in early life.Trial Registration: German Clinical Trials Register DRKS00011065 (Date of registration 16-09-2016). [ABSTRACT FROM AUTHOR]

Background: To investigate the prevalence of child sex tourism (CST) in a large German community sample, and to compare those who made use of CST with other child sexual abusers regarding established characteristics and risk factors for child sexual abuse.Methods: Adult German men were recruited through a German market research panel and questioned by means of an anonymous online survey. Group assignment was accomplished based on information on previous sexual contacts with children and previous use of CST. Characteristics and risk factors were compared between the groups using t- and Chi-square tests. Binary logistic regression analysis was performed to predict CST. Data collection was conducted in 2013, data analysis in January 2015.Results: Out of 8718 men, 36 (0.4%) reported CST use. The CST group differed from the nonCST group (n = 96; 1.1%) with regard to pedophilic sexual and antisocial behaviors as well as own experiences of sexual abuse. Social difficulties, pedophilic sexual interests, and hypersexuality were not distinct features in the CST group. Own experiences of sexual abuse, child prostitution use, and previous conviction for a violent offense predicted CST in a logistic regression model.Conclusions: This study is a first step to gain insight into the prevalence and characteristics of men using CST. Findings could help to augment prevention strategies against commercial forms of sexual abuse in developed as well as in developing countries by fostering the knowledge about the characteristics of perpetrators. [ABSTRACT FROM AUTHOR]