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Health technology assessments (HTAs) are used as a policy tool to appraise the clinical value, or cost effectiveness, of new medicines to inform reimbursement decisions in health care. As HTA organisations have been established in different countries, it has become clear that the outcomes of medicine appraisals can vary from country to country, even though the same scientific evidence in the form of randomised controlled trials is available. The extant literature explains such variations with reference to institutional variables and administrative rules. However, little research has been conducted to advance the theoretical understanding of how variations in HTA outcomes might be explained. This paper compares cases of HTA in England and Germany using insights from Kuhn (1962, The Structure of Scientific Revolutions, 2nd edn. Chicago: The University of Chicago Press) and Hall (1993, Policy paradigms, social learning, and the state: the case of economic policymaking in Britain. Comparative Politics 25, 275-296) to demonstrate how policy paradigms can explain the outcomes of HTA processes. The paper finds that HTA outcomes are influenced by a combination of logical issues that require reasoning within a paradigm, and institutional and political issues that speak to the interaction between ideational and interest-based variables. It sets out an approach that advances the theoretical explanation of divergent HTA outcomes, and offers an analytical basis on which to assess current and future policy changes in HTA. [ABSTRACT FROM AUTHOR]

Objective: The prognosis for ovarian cancer patients remains poor. A key to maximizing survival rates is early detection and treatment. This requires an accurate prediction of malignancy. Our study seeks to improve the accuracy of prediction by focusing on early subjective assessment of malignancy. We therefore investigated the assessment of patients themselves in comparison to the assessment of physicians.Methods: One thousand three hundred and thirty patients participated in a prospective and multicenter study in six hospitals in Berlin. Using univariate analysis and multivariate logistic regression models, we measured the accuracy of the early subjective assessment in comparison to the final histological outcome. Moreover, we investigated factors related to the assessment of patients and physicians.Results: The patients' assessment of malignancy is remarkably accurate. With a positive predictive value of 58%, the majority of patients correctly assessed a pelvic mass as malignant. With more information available, physicians achieved only a slightly more accurate prediction of 63%.Conclusions: For the first time, our study considered subjective factors in the diagnostic process of pelvic masses. This paper demonstrates that the patients' personal assessment should be taken seriously as it can provide a significant contribution to earlier diagnosis and thus improved therapy and overall prognosis. [ABSTRACT FROM AUTHOR]

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]

Introduction: The U.S. Army medics are often the first responders in the care of sick and injured soldiers on the battlefield, sick call in a Role 2 aid station and garrison clinics. Sick call medics are required to utilize the Algorithm Directed Troop Medical Care (ADTMC) to care for and then render a disposition for these soldiers. The current ADTMC manual is a thick, heavy paper manual. A desktop and smartphone application has been developed that contains the entire ADTMC manual algorithm-based content. Our goal is to enhance the medics' clinical learning and critical thinking skills while improving their evaluation, disposition, and documentation during patient encounters.Materials and Methods: The application was field-tested with the 173rd IBCT (A) while attending a field exercise at Grafenwoehr, Germany. At the unit's Role 2 tent setup, the use of the paper manual to the utilization of the same material via the ADTMC application was compared by observing the medics' workflows directly while they were caring for ill and injured soldiers.Results: Medics, while examining patients, would demonstrate 50% faster exam time using the application compared to medics using only the manual. Moreover, a 50% decrease in document processing time as a result of digitization of the paper documentation process was confirmed. The application ("app") enabled the medics to continue their screening assessments and patient disposition duties on a desktop computer or a smartphone without the need to refer to the paper manual.Conclusion: Medics, by adopting this tool, will become quicker, more efficient, and develop critical thinking skills. In other words, the ability to objectively evaluate patients in order to form a proper disposition of sick and injured soldiers during training, in the field, as well as in garrison. When utilized properly, the ADTMC application ensures that soldiers reporting to sick call are expeditiously routed to the appropriate level of care, and is a vehicle for further training for medics in the care of soldiers. [ABSTRACT FROM AUTHOR]

Aims: This paper examines the addictive potential of 8 different Internet applications, distinguishing male and female users. Moreover, differential correlates of problematic use are investigated in Internet gamers (IG) and generalized Internet users (GIU).Method: In a representative sample of 5,667 adolescents aged 12-19 years, use of Internet applications, problematic Internet use, psychopathologic symptoms (emotional problems, hyperactivity/inattention, and psychosomatic complaints), personality (conscientiousness and extraversion), psychosocial correlates (perceived stress and self-efficacy), and coping strategies were assessed. The addictive potential of Internet applications was examined in boys and girls using regression analysis. MANOVAs were conducted to examine differential correlates of problematic Internet use between IG and GIU.Results: Chatting and social networking most strongly predicted problematic Internet use in girls, while gaming was the strongest predictor in boys. Problematic IG exhibited multiple psychosocial problems compared to non-problematic IG. In problematic Internet users, GIU reported even higher psychosocial burden and displayed dysfunctional coping strategies more frequently than gamers.Conclusion: The results extend previous findings on the addictive potential of Internet applications and validate the proposed distinction between specific and generalized problematic Internet use. In addition to Internet gaming disorder, future studies should also focus on other highly addictive Internet applications, that is, chatting or social networking, regarding differential correlates of problematic use. [ABSTRACT FROM AUTHOR]

Objective: The goal of the present paper is to provide evidence on the behavior of physician practice cost functions.Data Sources: Our study is based on the data of 3686 physician practices in Germany for the years 2006 to 2008.Study Design: We apply a translog functional form and include a comprehensive set of variables that have not been previously used in this context. A system of four equations using three-stage least squares is estimated.Principal Findings: We find that a higher degree of specialization leads to a decrease in costs, whereas quality certification increases costs. Costs of group practices are higher than of solo practices. The latter finding can be explained by the existence of indivisibilities of expensive technical equipment. Smaller practices do not reach the critical mass to invest in certain technologies, which leads to differences in the type of health care services provided by different practice types.Conclusions: This is the first study to use physician practices as the unit of observation and to consider the endogenous character of physician input. Our results suggest that identifying factors that influence physician practice costs is important for providing evidence-based physician payment systems and to enable decision-makers to set incentives effectively. [ABSTRACT FROM AUTHOR]

Background and Objectives: Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout.Design: Two-arm, Internet-based, randomized, wait-list controlled trial (RCT).Methods: Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21.Results: Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75).Conclusions: The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely. [ABSTRACT FROM AUTHOR]

In response to the growing burden of obesity, public primary prevention programs against obesity have been widely recommended. Several studies have estimated the cost-effectiveness of diabetes-prevention trials for different countries. Nevertheless, it is still controversial if prevention conducted in more real-world settings and among people with increased risk but not yet exhibiting increased glucose tolerance can be a cost-saving strategy to cope with the obesity epidemic. We examine this question in a simulation model based on the results of the M.O.B.I.L.I.S program, a German lifestyle intervention to reduce obesity, which is directed on the high-risk group of people who are already obese. The contribution of this paper is the use of 4-year follow-up data on the intervention group and a comparison with a control group formed by SOEP respondents as inputs in a Markov model of the long-term cost savings through this intervention due to the prevention of type 2 diabetes. We show that from the point of view of a health insurer, these programs can pay for themselves. [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]

Objective: The clinical symptoms of schizophrenia are associated with serious social, quality of life and functioning alterations. Typically, data on health utilities are not available in clinical studies in schizophrenia. This makes the economic evaluation of schizophrenia treatments challenging. The purpose of this article was to provide a mapping function to predict unobserved utility values in patients with schizophrenia from the available clinical and socio-demographic information.Methods: The analysis was performed using data from EuroSC, a 2-year, multi-centre, cohort study conducted in France (N = 288), Germany (N = 618), and the UK (N = 302), totalling 1208 patients. Utility was calculated based on the EQ-5D questionnaire. The relationships between the utility values and the patients' socio-demographic and clinical characteristics (Positive and Negative Syndrome Scale--PANSS, Calgary Depression Scale for Schizophrenia--CDSS, Global Assessment of Functioning--GAF, extra-pyramidal symptoms measured by Barnes Akathisia Scale-BAS, age, sex, country, antipsychotic type) were modelled using a random and a fixed individual effects panel linear model.Results: The analysis demonstrated the prediction ability of the used parameters for estimating utility measures in patients with schizophrenia. Although there are small variations between countries, the same variables appear to be the key predictors. From a clinical perspective, age, gender, psychopathology, and depression were the most important predictors associated with the EQ-5D.Conclusion: This paper proposed a reliable, robust and easy-to-apply mapping method to estimate EQ-5D utilities based on demographic and clinical measures in schizophrenia. [ABSTRACT FROM AUTHOR]

Background: Neighborhood characteristics are important determinants of individual health and well-being. For example, characteristics such as noise and pollution affect health directly, while other characteristics affect health and well-being by either providing resources (e.g. social capital in the neighborhood), which individuals can use to cope with health problems, or limiting the use thereof (e.g. crime). This also suggests that there might be age differentials in the impact of these characteristics, since individuals at different stages of life might need different resources. However, there is a lack of empirical evidence on age differentials in associations between well-being, health, and neighborhood characteristics.Objective: This paper studies associations between a wide range of neighborhood characteristics with the health and well-being of residents of the greater Berlin area. In particular, we focus on differences in the effects between younger (aged 20-35) and older (aged 60+) residents.Methods: We used data from the Berlin Aging Study II (312 younger and 993 older residents of the Berlin metropolitan area in Germany). We used survey data on health and well-being, combined these with subjective perceptions of the neighborhood, and geo-referenced indicators on the neighborhood, e.g. amenities (public transport, physicians, and hospitals).Results: The results show that access to public transportation is associated with better outcomes on all measures of health and well-being, and social support is associated with higher life satisfaction and better mental health. There are considerable differences between both age groups: while the associations between access to public transport and health and well-being are similar for both age groups, neighborhood social capital shows stronger associations for older residents. However, the difference is not always statistically significant.Conclusion: Having access to services is associated with better health and well-being regardless of age. Local policy makers should focus on lowering barriers to mobility in order to improve the health and well-being of the population. Since the social capital of a neighborhood is associated with better health and well-being among older residents, investments that increase social capital (e.g. community centers) might be warranted in neighborhoods with higher shares of older residents. [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]

Background: One in eight women is diagnosed with breast cancer in the course of their life. As systematic palliative treatment has only a limited effect on survival rates, the concept of health-related quality of life (HRQoL) was developed for measurement of patient-centered outcomes. Various studies have already demonstrated the reliability of paper-based patient-reported outcome (pPRO) and electronic patient-reported outcome (ePRO) surveys and that the 2 means of assessment are equally valid.Objective: The aim of this study was to analyze the acceptance and evaluation of a tablet-based ePRO app for breast cancer patients and to examine its suitability, effort, and difficulty in the context of HRQoL and sociodemographic factors.Methods: Overall, 106 women with adjuvant or advanced breast cancer were included in a 2-center study at 2 major university hospitals in Germany. Patients were asked to answer HRQoL and PRO questionnaires both on a tablet on-site using a specific eHealth assessment website and on paper. The suitability, effort, and difficulty of the app and self-reported technical skills were also assessed. Only the results of the electronically acquired data are presented here. The results of the reliability of the pPRO data have already been published elsewhere.Results: Patients regarded the ePRO assessment as more suitable (80/106, 75.5%), less stressful (73/106, 68.9%), and less difficult (69/106, 65.1%) than pPRO. The majority of patients stated that ePRO assessment improves health care in hospitals (87/106, 82.1%). However, evaluation of ePROs depended on the level of education (P=.003) in the dimensions of effort and difficulty (regression analysis). The app was rated highly in all categories. HRQoL data and therapy setting did not show significant correlations with the app's evaluation parameters.Conclusions: The results indicate that ePRO surveys are feasible for measuring HRQoL in breast cancer patients and that those patients prefer ePRO assessment to pPRO assessment. It can also be seen that patients consider ePRO assessment to improve hospital health care. However, studies with larger numbers of patients are needed to develop apps that address the needs of patients with lower levels of education and technical skills. [ABSTRACT FROM AUTHOR]

The continued growth in the economic evaluation of healthcare over the past 25 years has led to a shortage of trained health economists globally, leading to a number of universities and/or national governments developing specialised health economics programmes to train more health economists. One of the common problems with many of these training programmes is that they only educate new health economists to the Masters level, and as such they are unable to cover the many skills needed by a successful health economist. Furthermore, government and industry interests have ensured that economic evaluation is a heavily regulated environment that gives little incentive to seek further education. These two related factors (under-education and over-regulation) have lead to a situation where economic evaluation methods may adversely limit innovation of therapeutics and devices in clinical areas that perform badly when evaluated on the cost per QALY scale. The good news, however, is that the tide is turning and theoretically sound adjustments (such as risk adjustments and stated preferences) to the current paradigm are now being considered. This, of cause, is just the tip of the iceberg with other important issues such as time preference and the endogeneity of preference remaining very much under-researched areas in health. This paper concludes that many of these real-world issues, such as patient preferences, can be avoided by using artificial objective functions such as cost per QALY, but this comes at the cost of irrelevance and the misallocation of resources. If we are to meet all of the future challenges in economic evaluation in healthcare then we must focus more on advanced education and far less on the regulation of health economists. [ABSTRACT FROM AUTHOR]

Unlabelled: Deaths in temporal association with vaccination of hexavalent vaccines have been recently reported. The objective of this paper is to assess whether these temporal associations can be attributed to chance. Standardised mortality ratios (SMR) for deaths within 1 to 28 days after administration of either of the two hexavalent vaccines in the 1st and 2nd year of life were determined using the respective annual rates for sudden unexpected deaths (SUDs) from the national vital statistics. The distribution of SUD cases and the vaccination uptake by month were estimated from surveys and sales figures for the individual vaccines. Sensitivity analyses were performed to account for limitations in the data sources. For one of the vaccines, Vaccine B, all SMRs were well below one. For the other, Vaccine A, SMRs exceeded one insignificantly on the 1st day after vaccination in the 1st year of life. In the 2nd year of life, however, the SMRs for SUD cases within 1 day of vaccination with vaccine A were 31.3 (95% CI 3.8-113.1; two cases observed; 0.06 cases expected) and 23.5 (95% CI 4.8-68,6) for within 2 days after vaccination (three cases observed; 0.13 cases expected). Extensive sensitivity analyses could not attribute these findings to limitations of the data sources.Conclusion: These findings based on spontaneous reporting do not prove a causal relationship between vaccination and sudden unexpected deaths. However, they constitute a signal for one of the two hexavalent vaccines which should prompt intensified surveillance for unexpected deaths after vaccination. [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]

Excessive alcohol consumption is one of the most important lifestyle factors affecting the disease burden in the Western world. The results of treatment in daily practice are modest at best. The aim of the RESCueH programme is to develop and evaluate methods, which are as practice-near as possible, and therefore can be implemented quickly and easily in everyday clinical practice. It is the first clinical alcohol programme to be transatlantic in scope, with implementation in treatment centers located in Denmark, Germany and the US. The RESCueH programme comprises 5 randomized controlled trials, and the studies can be expected to result in (1) more patients starting treatment in specialized outpatient clinics, (2) a greater number of elderly patients being treated, (3) increased patient motivation for treatment and thus improved adherence, (4) more patients with stable positive outcomes after treatment and (5) fewer patients relapsing into harmful drinking. The aim of this paper is to discuss the rationale for the RESCueH programme, to present the studies and expected results. [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]

Background: A growing body of literature aims to improve understanding of the operations of drug trafficking markets through conducting interviews with dealers and traffickers. Insight into how these individuals conduct business can provide evidence to inform the efforts by policy makers, law enforcement and practitioners to disrupt illicit markets. This paper aims to make a contribution to this evidence base by extending the number of European countries in which interviews have been conducted with incarcerated drug dealers and traffickers.Methods: It draws on interviews with 135 men convicted of offences related to the distribution or sale of heroin or cocaine and imprisoned in Italy, Slovenia and Germany. The research was conducted as part of the Reframing Addictions Project (ALICE-RAP) funded by the European Commission. The sample was diverse. It included a range of nationalities and some individuals who were members of organised crime groups. The majority of the interviewees were dealers who sold at the retail and street level, but there were some who were importers and wholesalers.Findings: Most dealers in each of the three countries reported having more than one regular supplier, and were able to respond to periods of over and under supply without losing customers. Supply arrangements varied in terms of frequency and quantities bought. Dealers engaged in repeated transactions and their relationships with customers were based on trust and reputation. Dealers aimed to sell to regular customers and to provide drugs of good quality. While dealers sought to maximise their profits by cutting drugs with cutting agents, the quality of drugs that they sold could affect their reputation and thus their profits and position in the market. Lastly, while there are some significant differences in the approach between those involved in organised crime groups and those who are not, and between street dealers and those operating at higher levels of the market, there were striking similarities in terms of the day-to-day operational concerns and modes of relationship management.Conclusions: Interviewees' arrangements for securing supplies of drugs provide support to the notion that drug markets are resilient and flexible. Our findings correspond with other empirical research in relation to the centrality of trust in the practical operation of supply and sale of drugs. The research highlights some differences, but important similarities between dealers who were part of organised crime groups and those who were not; dealers all faced some common challenges and adopted some common responses to these. [ABSTRACT FROM AUTHOR]

Background: Cannabis prohibition can generally be regarded as the main driver for home growing of marijuana. In this paper, I discuss the impact of drug prohibition on cannabis cultivators from the three German-speaking countries: Germany, Austria and Switzerland. In particular, this refers to the questions; how illicitness influences motivations for growing; which precautionary measures are taken against the risk of discovery; how penal consequences differ in the three countries and how these aspects are linked to each other.Methods: The results come from a sample of 1578 respondents from the German-language online survey conducted following the International Cannabis Cultivation Questionnaire (ICCQ). The survey was carried out in late 2012 and early 2013.Results: While most of the reasons for growing cannabis relate to avoiding negative consequences of prohibition, the illicitness of cannabis also plays a major role for concern about the cultivation activities as well as measures to avoid negative consequences. Swiss growers are less worried about their activity compared to respondents from Germany or Austria.Conclusion: The results confirm the notion that the illicitness of cannabis is the main drive for the private cultivation of the plant. At the same time, prohibition is the principal reason for concern regarding the growing activity. The severity of possible sentences seems to be linked to the degree of concern and precautionary measures. [ABSTRACT FROM AUTHOR]

This paper investigates the average effects of firm-provided workplace health promotion measures on labour market outcomes of the firms' employees. Exploiting linked employer-employee panel data that consist of rich survey-based and administrative information on firms, workers and regions, we apply a flexible propensity score matching approach that controls for selection on observables and time-constant unobserved factors. While the effects of analysing sickness absenteeism appear to be rather limited, our results suggest that health circles/courses increase tenure and job stability across various age groups. A key finding is that health circles/courses strengthen the labour force attachment of elderly employees (51-60), implying potential cost savings for public transfer schemes such as unemployment insurance or early retirement schemes. [ABSTRACT FROM AUTHOR]

This paper investigates the mechanisms behind the health effects of retirement. Using a Regression Discontinuity Design to exploit financial incentives in the German pension system for identification, I find that retirement improves subjective health status and mental health, while also reducing outpatient care utilization. I explore a wide range of health behaviors, time use, and effect heterogeneity as potential mechanisms. Relief from work-related stress and strain, increased sleep duration as well as more frequent physical exercise seem to be key mechanisms through which retirement affects health. [ABSTRACT FROM AUTHOR]

This paper studies the effects of immigration on health. Specifically, we merge information on individual characteristics from the German Socio-Economic Panel (1984-2009) with detailed local labour market characteristics, and we then exploit the longitudinal component of the data to determine how immigration affects the health of both immigrants and natives over time. We find that immigrants to Germany are healthier than natives upon their arrival (the healthy immigrant effect) but that immigrants' health deteriorates over time. We show that the convergence in health is heterogeneous across immigrants and occurs more rapidly among those working in more physically demanding jobs. Because immigrants are significantly more likely to work in strenuous occupations, we investigate whether changes in the spatial concentration of immigrants affect the health of the native population. Our results suggest that immigration reduces the likelihood that residents will report negative health outcomes. We show that these effects are concentrated in blue-collar occupations and are stronger among low-educated natives. Improvements in natives' average working conditions and workloads help explain the positive effects of immigration on the health of the native population. [ABSTRACT FROM AUTHOR]

Importance: Intraoperative handovers of anesthesia care are common. Handovers might improve care by reducing physician fatigue, but there is also an inherent risk of losing critical information. Large observational analyses report associations between handover of anesthesia care and adverse events, including higher mortality.Objective: To determine the effect of handovers of anesthesia care on postoperative morbidity and mortality.Design, Setting, and Participants: This was a parallel-group, randomized clinical trial conducted in 12 German centers with patients enrolled between June 2019 and June 2021 (final follow-up, July 31, 2021). Eligible participants had an American Society of Anesthesiologists physical status 3 or 4 and were scheduled for major inpatient surgery expected to last at least 2 hours.Interventions: A total of 1817 participants were randomized to receive either a complete handover to receive anesthesia care by another clinician (n = 908) or no handover of anesthesia care (n = 909). None of the participating institutions used a standardized handover protocol.Main Outcomes and Measures: The primary outcome was a 30-day composite of all-cause mortality, hospital readmission, or serious postoperative complications. There were 19 secondary outcomes, including the components of the primary composite, along with intensive care unit and hospital lengths of stay.Results: Among 1817 randomized patients, 1772 (98%; mean age, 66 [SD, 12] years; 997 men [56%]; and 1717 [97%] with an American Society of Anesthesiologists physical status of 3) completed the trial. The median total duration of anesthesia was 267 minutes (IQR, 206-351 minutes), and the median time from start of anesthesia to first handover was 144 minutes in the handover group (IQR, 105-213 minutes). The composite primary outcome occurred in 268 of 891 patients (30%) in the handover group and in 284 of 881 (33%) in the no handover group (absolute risk difference [RD], -2.5%; 95% CI, -6.8% to 1.9%; odds ratio [OR], 0.89; 95% CI, 0.72 to 1.10; P = .27). Nineteen of 889 patients (2.1%) in the handover group and 30 of 873 (3.4%) in the no handover group experienced all-cause 30-day mortality (absolute RD, -1.3%; 95% CI, -2.8% to 0.2%; OR, 0.61; 95% CI, 0.34 to 1.10; P = .11); 115 of 888 (13%) vs 136 of 872 (16%) were readmitted to the hospital (absolute RD, -2.7%; 95% CI, -5.9% to 0.6%; OR, 0.80; 95% CI, 0.61 to 1.05; P = .12); and 195 of 890 (22%) vs 189 of 874 (22%) experienced serious postoperative complications (absolute RD, 0.3%; 95% CI, -3.6% to 4.1%; odds ratio, 1.02; 95% CI, 0.81 to 1.28; P = .91). None of the 19 prespecified secondary end points differed significantly.Conclusions and Relevance: Among adults undergoing extended surgical procedures, there was no significant difference between the patients randomized to receive handover of anesthesia care from one clinician to another, compared with the no handover group, in the composite primary outcome of mortality, readmission, or serious postoperative complications within 30 days.Trial Registration: ClinicalTrials.gov Identifier: NCT04016454. [ABSTRACT FROM AUTHOR]

Background: The desire to have children has been declining globally, especially in industrialized nations. This study examines the physical health correlates, and positive and negative mental health correlates of the wish to have a child across time and in two countries.Method: Questionnaire data were obtained from large-scale university samples of 12,574 participants in Germany and China.Results: The wish to have a child (child wish) is related to positive and negative mental health in China and, to a lesser degree, in Germany. Child wish is positively related to some aspects of mental and somatic health for Chinese women and men, negatively to depression for Chinese and German men and Chinese women, and positively to stress for German men, with generally small effects. Effects hold when controlling for age, partnership status, and family affluence. Most relationships were almost equal between women and men (in both China and Germany), and between countries with the exception of two different paths in each gender group. That is, having a partner is associated with a higher child wish in both Chinese and German female students. In China, older female students are more likely to want to have a child, while older female students in Germany are less likely to want to have a child. Neither partnership nor age predict child wish for the next year.Conclusion: In sum, Chinese students reported feeling more positively about having children when they were happy and healthy, with the exception that highly satisfied Chinese males report lower child wish in the next year. More depressed Chinese and German men and Chinese women reported lowered child wish, and stressed German men reported more child wish. Older students reported more (Chinese) or less (German) child wish depending on country. [ABSTRACT FROM AUTHOR]

Background: Vaccination rates for measles, mumps, and rubella (MMR) and diphtheria, tetanus, pertussis, and polio (Tdap-IPV) are not optimal among German adolescents. Education in combination with easy access to vaccination may be a promising approach to improve vaccination rates. The present paper describes a pilot study of a planned cluster randomized controlled trial (cRCT) in which we aim to improve MMR and Tdap-IPV vaccination rates together with knowledge and self-efficacy in a school setting.Methods: The study covered 863 students from 41 classes of four schools. The optimization and feasibility of access to schools, recruitment strategies, intervention, and assessment procedures were examined. The course and content of the educational unit were evaluated with a mixed-methods approach. A pre-post measurement design was tested for the vaccination rate in all schools. Additionally, at two schools, improvement in vaccination-related knowledge and perceived self-efficacy were measured by questionnaire pre-educational unit (n=287) and post-educational unit (n=293). The remaining two schools provided only postintervention data. Finally, we evaluated the psychometric properties (i.e., reliability, retest reliability, and change rates) of the questionnaire, applying Cronbach's alpha, factor analyses, generalized estimating equations and linear mixed models.Results: The findings of the pilot study indicated good feasibility. Of the total sample, 437 students (50.9%) brought their vaccination cards to school, 68 students received Tdap-IPV vaccinations, and 11 received MMR vaccinations. Out of six knowledge questions, on average, the students had M=2.84 (95% CI [2.69, 3.10]) correct answers before and M=4.45 (95% CI [4.26, 4.64]) after the class. Ranging from 1 to 4, the self-efficacy scale changed by 0.3 points (p <.001); Cronbach's alpha was 0.67 and 0.76 pre- and post-educational unit, respectively, and a one-factor solution was found. Content analysis of the five semistructured group interviews (n=12, 58.3% female) showed that all students found the length of the intervention to be appropriate. The teaching methods, including interactive and social media components, were perceived as very good.Conclusions: A school-based educational and on-site vaccination intervention appears to be feasible in terms of procedures and the adequacy of the instruments for the adolescent target group.Trial Registration: ISRCTN, ISRCTN18026662 . Pilot study for main trial registered 8 December 2017. [ABSTRACT FROM AUTHOR]

Objectives: Health-care information systems are particularly security-critical. In order to make these applications secure, the security analysis has to be an integral part of the system design and IT management process for such systems.Methods: This work presents the experiences and results from the security analysis of the system architecture of the German Health Card, by making use of an approach to model-based security engineering that is based on the UML extension UMLsec. The focus lies on the security mechanisms and security policies of the smart-card-based architecture which were analyzed using the UMLsec method and tools.Results: Main results of the paper include a report on the employment of the UMLsec method in an industrial health information systems context as well as indications of its benefits and limitations. In particular, two potential security weaknesses were detected and countermeasures discussed.Conclusions: The results indicate that it can be feasible to apply a model-based security analysis using UMLsec to an industrial health information system like the German Health Card architecture, and that doing so can have concrete benefits (such as discovering potential weaknesses, and an increased confidence that no further vulnerabilities of the kind that were considered are present). [ABSTRACT FROM AUTHOR]

Objectives: In the field of open electronic health records (EHRs), openEHR as an archetype-based approach is being increasingly recognised. It is the objective of this paper to shortly describe this approach, and to analyse how openEHR archetypes impact on health professionals and semantic interoperability.Methods: Analysis of current approaches to EHR systems, terminology and standards developments. In addition to literature reviews, we organised face-to-face and additional telephone interviews and tele-conferences with members of relevant organisations and committees.Results: The openEHR archetypes approach enables syntactic interoperability and semantic interpretability -- both important prerequisites for semantic interoperability. Archetypes enable the formal definition of clinical content by clinicians. To enable comprehensive semantic interoperability, the development and maintenance of archetypes needs to be coordinated internationally and across health professions. Domain knowledge governance comprises a set of processes that enable the creation, development, organisation, sharing, dissemination, use and continuous maintenance of archetypes. It needs to be supported by information technology.Conclusions: To enable EHRs, semantic interoperability is essential. The openEHR archetypes approach enables syntactic interoperability and semantic interpretability. However, without coordinated archetype development and maintenance, 'rank growth' of archetypes would jeopardize semantic interoperability. We therefore believe that openEHR archetypes and domain knowledge governance together create the knowledge environment required to adopt EHRs. [ABSTRACT FROM AUTHOR]

Objectives: The introduction of information system components (ISCs) usually leads to a change in existing processes, e.g. processes of patient care. These processes might become even more complex and variable than before. An early participation of end users and a better understanding of human factors during design and introduction of ISCs are key factors for a successful introduction of ISCs in health care. Nonetheless no specialized methods have been developed until now to systematically support the integration of ISCs in existing processes of patient care while taking into account these requirements. In this paper, therefore, we introduce a procedure model to implement Concepts for Smooth Integration of ISCs (CSI-ISC).Methods: Established theories from economics and social sciences have been applied in our model, among them the stress-strain-concept, the contrastive task analysis (KABA), and the phase model for the management of information systems.Results: CSI-ISC is based on the fact that while introducing new information system components, users experience additional workload. One essential aim during the introduction process therefore should be to systematically identify, prioritize and ameliorate workloads that are being imposed on human beings by information technology in health care. To support this, CSI-ISC consists of a static part (workload framework) and a dynamic part (guideline for the introduction of information system components into existing processes of patient care).Conclusions: The application of CSI-ISC offers the potential to minimize additional workload caused by information system components systematically. CSI-ISC rationalizes decisions and supports the integration of the information system component into existing processes of patient care. [ABSTRACT FROM AUTHOR]

Objectives: Our objectives were to analyze and assess data formats for their suitability for conclusive and secure long-term archiving and to develop a concept for legally secure transformation of electronically signed documents that are not available in data formats appropriate for long-term archiving.Methods: On the basis of literature review and Internet searches we developed general evaluation criteria to assess data formats with regard to their suitability for conclusive and secure long-term archiving. The assessment of data formats refers to format specifications and available literature. For the analyses of the transformation of signed documents we analyzed legal requirements on the basis of laws and ordinances as well as technical requirements by means of literature reviews, Internet searches and technical specifications.Results: The following evaluation criteria are suited for this kind of assessment of data formats: transparency and standardization, stability, presentation and security. According to our assessment the following data formats are most suitable for conclusive and secure long-term archiving: PDF for formatted and unstructured text documents, XML for markup languages, TIFF for images in general, DICOM for medical images and S/MIME for the storage of e-mail. To transform electronically signed documents we propose an elementary procedure and universal basic model in form of an XML schema definition that includes the necessary legal and technical information.Conclusions: If electronic documents are to replace paper-based documents in patient records, they have to conform to the criteria for secure long-term archiving. The analyzed data formats are to be extended by mechanisms to guarantee the long-term security of electronic signatures. To transform large quantities of documents in a legally secure way, our basic model has to be extended for automated procedures. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia has a variety of clinical profiles, disabilities and outcomes requiring responsive management and the devotion of considerable resources. The primary objective of the European Schizophrenia Cohort (EuroSC) is to relate the types of treatment and methods of care to clinical outcome. Secondary objectives include the assessment of treatment needs in relation to outcome, the calculation of resource consumption associated with different methods of care, and the identification of prognostic factors.Method: EuroSC is a naturalistic follow-up of a cohort of people aged 18 to 64 years, suffering from schizophrenia and in contact with secondary psychiatric services. The study was done in nine European centres, in France (N = 288), Germany (N = 618), and Britain (N = 302). Participants were interviewed at 6-monthly intervals for a total of 2 years. This initial paper describes the methods used and presents clinical and social baseline data.Results: The clinical and socio-demographic differences between patients from the different countries were small. However, patients from Britain were considerably more likely than their continental counterparts to have a history of homelessness, rooflessness or imprisonment, even when social and clinical differences between the samples were controlled.Conclusions: The samples were largely similar in clinical terms. Thus, the social differences between the samples seem likely to be due more to the societal context and may reflect relatively benign situations in the continental locations of our study. [ABSTRACT FROM AUTHOR]

This paper presents two studies (one single case and one comparative study) examining change processes within individual therapy sessions as well as during the course of treatment. The Therapeutic Cycle Model (TCM), developed for general psychotherapy to objectify change events in the course of psychotherapies, is applied to transcribed tape recordings of therapy sessions with sexual offenders. The TCM focuses on emotional experience and cognitive mastery and uses computer assisted text analysis. In addition to the TCM approach clinical ratings are used as independent criteria. The predicted relationship between the phases of the TCM and scores on the respective scales of the clinical ratings were supported. [ABSTRACT FROM AUTHOR]

Background: In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry.Methods: The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization.Results: From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009).Conclusion: Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention. [ABSTRACT FROM AUTHOR]

Objective: To investigate the occupational and financial consequences for parents following the onset of type 1 diabetes in their child.Research Design and Methods: A questionnaire assessing occupational and financial situations before and in the first year after the onset of diabetes was distributed to all families with a child ≤14 years of age at diagnosis with a diabetes duration of at least 12 months in nine German pediatric diabetes centers.Results: Data of 1,144 children (mean age at diagnosis 6.7 [3.6] years; 46.5% female) and their families were obtained. Mothers' occupational status reflected in paid working hours was significantly reduced in the first year after their child's diabetes diagnosis (P < 0.001). Overall, 15.1% of mothers stopped working, and 11.5% reduced working hours. Mothers of preschool children were particularly affected. Fathers' working status hardly changed (P = 0.75). Nearly half of the families (46.4%) reported moderate to severe financial losses. Compared with an earlier similar study in 2003, significant negative occupational consequences for mothers and financial burden on families remained unchanged in 2018 (P = 0.59 and 0.31, respectively).Conclusions: Mothers of young children with newly diagnosed diabetes experienced negative consequences in their occupational situation. This inequality for mothers can have long-term negative consequences for their mental health and future economic situation. There is an urgent need for action to reduce the burden on families and to provide professional, social, and regulatory support, especially for mothers of young children with diabetes. [ABSTRACT FROM AUTHOR]

Clinical trials for the treatment of schizophrenia now often include cognitive assessments in addition to clinical ratings of symptoms. Recently, these trials have included cross-national assessments. It is not clear if translated psychological tests produce consistent results across different languages. This paper presents the results of a study of the comparability of the results of cognitive assessments in different English-speaking countries and a number of countries where tests were translated into other languages. Performance on tests of executive functioning, verbal and visuo-spatial learning and memory, language skills, psychomotor speed, and vigilance was compared across the first episode patients with schizophrenia (n=301) assessed in six different languages (English, French, Finnish, German, Hebrew, and Afrikaans), including two different countries where patients were assessed in English and other languages: Canada (French) and South Africa (Afrikaans). The variance in performance across the sites tested in English was as large as the variance between English and non-English speakers when all tests were considered. Performance differences across English and other languages were found only for executive functions, vigilance, and psychomotor speed, with executive functioning differences nonsignificant when education was considered. No differences were found between English and non-English speakers in Canada. These results suggest that the translation of tests of memory and verbal skills can lead to consistent results across translated versions of the tests. Differences between countries were greater than differences between languages, suggesting the need to consider representativeness of patient samples in terms of local educational attainment. In general, these data support the validity of cross-national neuropsychological assessments. [Copyright &y& Elsevier]

This study examined the prevalence of sexual aggression perpetration and victimization in a sample of 1,172 students (755 female, 417 male) from four universities in Germany. All participants were asked about both victimization by, and perpetration of, sexual aggression since the age of 14 years, using the Sexual Aggression and Victimization Scale (SAV-S). Prevalence rates were established for different coercive strategies, sexual acts, and victim-perpetrator relationships. Both same-sex and opposite-sex victim-perpetrator constellations were examined. The overall victimization rate was 62.1% for women and 37.5% for men. The overall perpetration rate was 17.7% for men and 9.4% for women. Prevalence rates of both victimization and perpetration were higher for participants who had sexual contacts with both opposite-sex and same-sex partners than for participants with exclusively opposite-sex partners. Significant overlap was found between victim and perpetrator status for men and women as well as for participants with only opposite-sex and both opposite-sex and same-sex partners. A disparity between (higher) victimization and (lower) perpetration reports was found for both men and women, suggesting a general underreporting of perpetration rather than a gendered explanation in terms of social desirability or the perception of consent cues. The findings are placed in the international research literature on the prevalence of sexual aggression before and after the #metoo campaign, and their implications for prevention efforts are discussed. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the work situation of lung cancer survivors and to identify the factors associated with their returning to work.Methods: Descriptive analysis and logistic regression were used to evaluate study population characteristics and independent factors of subsequently returning to work. To analyze time to return to work, Cox regression was used.Results: The study sample included 232 lung cancer survivors of working age from 717 enrolled participants in the multi-center cross-sectional LARIS (Quality of Life and Psychosocial Rehabilitation in Lung Cancer Survivors) study. About 67% of the survivors were not employed during the survey. More than 51% of the survivors who were employed before their illness did not return to their work. The survivors who had returned to their careers were younger, associated with higher household income, lower fatigue score, and stable relationship and vocational training. Patients who received social service counseling showed a higher chance of regaining their career.Conclusions: Lung cancer survivors were found to be associated with a high risk of unemployment and very low professional reintegration after interruption due to illness. More comprehensive studies are needed to support lung cancer survivors and targeting of patients in need of special attention in rehabilitation that would benefit from the findings in the present study. [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]

Mantle cell lymphoma (MCL) is a non-Hodgkin's lymphoma with an often aggressive course, incurable by chemotherapy. Consolidation with high-dose therapy and autologous stem cell transplantation (autoSCT) has a low transplant-related mortality but does not lead to a survival plateau. Allogeneic stem cell transplantation (alloSCT) is associated with a higher early mortality, but can cure MCL. To investigate alloSCT for therapy of MCL, we conducted two prospective trials for de novo MCL (OSHO#74) and for relapsed or refractory MCL (OSHO#60). Fifteen and 24 patients were recruited, respectively. Induction was mainly R-DHAP alternating with R-CHOP. Conditioning was either Busulfan/Cyclophosphamide or Treosulfan/Fludarabin. Either HLA-identical siblings or matched-unrelated donors with not more than one mismatch were allowed. ATG was mandatory in mismatched or unrelated transplantation. Progression-free survival (PFS) was 62% and overall survival (OS) was 68% after 16.5-year follow-up. Significant differences in PFS and OS between both trials were not observed. Patients below 56 years and patients after myeloablative conditioning had a better outcome compared to patients of the corresponding groups. Nine patients have died between day +8 and 5.9 years after SCT. Data from 7 long-term surviving patients showed an excellent Quality-of-life (QoL) after alloSCT. AlloSCT for MCL delivers excellent long-term survival data. The early mortality is higher than after autoSCT; however, the survival curves after alloSCT indicate the curative potential of this therapy. AlloSCT is a standard of care for all feasible patients with refractory or relapsed MCL and should offer to selected patients with de novo MCL and a poor risk profile. For defining the position of alloSCT in the therapeutic algorithm of MCL therapy, a randomized comparison of autoSCT and alloSCT is mandatory. [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]

Intraoral scanners (IOS) have been used to quantify tooth wear, but so far they have not been systematically validated for monitoring of tissue loss. The aim of this in vitro study was to investigate whether progression of tissue loss can be detected with an IOS and whether IOS values agree with those obtained with noncontacting profilometry (PRO) serving as a standard method. Model jaws were mounted in a phantom head positioned in a dental chair. Flattened areas were prepared on the non-load-bearing cusps of the first molars (model teeth; n = 16) in order to fix flat enamel samples with an experimental area and a reference area. After baseline PRO and IOS, the experimental enamel area was stepwise etched with 35% H3PO4 gel (4 × 30 s and 4 × 15 s). After each etching, PRO and IOS was performed and the vertical tissue loss between the reference and experimental areas was measured, each at the same 3 measurement points. Furthermore, cupped cusps were simulated by stepwise preparation of the load-bearing cusps of the model teeth with a spherical diamond bur, and the maximum vertical depth after each preparation step was measured only by IOS. Trios3 (3Shape, Denmark), Carestream CS3600 (Carestream, USA) and an optical profilometer (MicroProf, Fries, Germany) were used to measure the flat areas of the enamel samples, whereas only IOS were used to measure curved surfaces on the load-bearing cupped cusps of the model teeth. The IOS data were analyzed with an external software (GOM Inspect, Germany) and with the respective internal IOS software. PRO revealed a mean (±SD) tissue loss of 17.1 ± 4.7 µm after 30-s etching steps and 10.1 ± 5.1 µm after the 15-s etching steps. IOS and software types were able to detect the progression of tissue loss after each etching step (p ≤ 0.001 each); Bland-Altmann plots revealed good agreement with PRO regardless of the order of tissue loss, and no systematic difference was found. Increasing cupped lesion depths were detected by all IOS, with no significant differences between IOS and analysis methods. IOS were able to detect small amounts of tissue loss under simulated clinical conditions and seem to be a promising tool for monitoring even initial erosive tooth wear. [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]

This article consists of a shortened and annotated translation of a paper on "An Interesting Oral Symptom Complex and Its Relationship to Addiction" by M. Wulff of Berlin, which was delivered before the German Psychoanalytic Society on April 12, 1932. The article describes four cases of an eating disorder in women that was characterized by binge eating, hypersomnolence, apathetic depression, and disparagement of the body image. After the eating binges, all four patients manifested periods of fasting, and two of the three, about whom such information is available, vomited. Translations of large excerpts of the case histories are presented together with a summary of Wulff's discussion. [ABSTRACT FROM AUTHOR]