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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]

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 shortage of qualified nurses is a problem of growing concern in many countries. Recruitment of internationally trained nurses has been used to address this shortage, but successful integration in the workplace is complex and resource intensive. For effective recruitment and retention, it is important to identify why nurses migrate and if their expectations are met to ensure their successful integration and promote a satisfying work climate for the entire nursing team. The aim of this study was to examine the perceptions of safety culture, work-life-balance, burnout and job demand of internationally trained nurses and associated host nurses in German hospitals. Methods: A multicentric, cross-sectional study was conducted with internationally trained nurses (n = 64) and host nurses (n = 103) employed at two university hospitals in the state of Baden-Wuerttemberg, Germany. An anonymous paper-based survey was conducted between August 2019 and April 2020. The questionnaire included sociodemographic questions, questions regarding factors related to migration, and the German version of the Assessment of your work setting Safety, Communication, Operational Reliability, and Engagement (SCORE) questionnaire. SCORE is divided into three sections: Safety Culture Domains (six subscales), Work-Life-Balance (one subscale), and Engagement Assessment Tool (four subscales). Results: Nurses who migrated to Germany were primarily seeking better working conditions, a higher standard of living, and professional development opportunities. Internationally trained nurses reported lower work-related burnout climate (Mean 55.4 (SD 22.5)) than host nurses (Mean 66.4 (SD 23.5)) but still at a moderately high degree (Safety Culture Domains). Host nurses indicated a higher workload (Mean 4.06 (SD 0.65)) (Engagement Assessment Tool) and a lower Work-Life-Balance (Mean 2.31 (SD 0.66)) (Work-Life-Balance) compared to nurses who trained abroad (Mean 3.67 (SD 0.81) and Mean 2.02 (SD 0.86), respectively). No differences were detected for the other subscales. The Safety Culture Domains and Engagement Assessment Tool showed room for improvement in both groups. Conclusion: The study suggest that the expectations migrant nurses had prior to migration may not be met and that in turn could have a negative impact on the integration process and their retention. With increasing recruitment of internationally trained nurses from within Europe but also overseas, it is crucial to identify factors that retain migrant nurses and assist integration. Trial registration: The study has been prospectively registered (27 June 2019) at the German Clinical Trial Register (DRKS00017465). [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 and objectives: Pressure ulcers (PUs) are a serious health problem. They can be considered as an indicator of the quality of health care and are associated with considerable cost increases for the health care system. The prevention of PUs is a major concern in hospital care. The aim of the study was to reveal the current PU prevention‐related processes and structures with a specific focus on the Accident and Emergency (A&E) Department. Method: In late 2018/early 2019, all German hospitals were invited to participate in a nationwide cross‐sectional survey. One standardized questionnaire was assigned to a representative of each hospital. The representative was asked to state what PU‐related structures and processes are implemented in their hospital, in general and specific to the A&E department. Besides mostly descriptive analysis, PU‐related processes were analysed on PU incidence in a multivariate linear regression model. Results: Two hundred seventy‐six hospitals participated in the survey. 63.4% (n = 175) of the participating hospitals had at least one PU manager. Skin inspection was the most frequently performed procedure. Although not recommended, 1.3% (2.1%) of the facilities still use sheepskins quite often (very often). In the regression model on PU incidence, only the process 'mobilization in bed' was statistically significantly associated. Although the risk of developing a PU in the emergency department is high, more than half of the facilities had no PU guidelines. Conclusion: Even if recommended procedures (skin inspection, 30° positioning) have been used frequently, regular training could help to bring new scientific findings such as the use of local skin protection dressings into clinical practice. Prevention guidelines should be established in all areas of care even for A&E as well as when patients are transferred inside or out of the hospital, where the risk of PU development was considered low. [ABSTRACT FROM AUTHOR]

Background: The results of recent surveys indicate that more than 50% of the German population has experience with complementary and alternative medicine (CAM) or uses CAM regularly. This study investigated the CAM usage and CAM-related needs of hospitalized patients at university medical centres in the state of Baden-Württemberg, Germany. Methods: A multi-centre, paper-based, pseudonymous survey was carried out by the members of the Academic Centre for Complementary and Integrative Medicine. Patients of all ages, regardless of sex, diagnosis and treatment, who were hospitalized in the Department of Cardiology, Gastroenterology, Oncology, Gynaecology or Surgery at the university medical centres in Freiburg, Heidelberg, Tübingen and Ulm were eligible for inclusion. Results: Of the 1275 eligible patients, 67% (n = 854) consented to participate in the survey. Forty-eight percent of the study participants stated that they were currently using CAM. The most frequently used therapies were exercise (63%), herbal medicine (54%) and dietary supplements (53%). Only 16% of the patients discussed CAM usage with their attending physician. Half of the patients (48%) were interested in CAM consultations. More than 80% of the patients desired reliable CAM information and stated that physicians should be better informed about CAM. Conclusions: The frequency of CAM usage and the need for CAM counselling among hospitalized patients at university medical centres in Baden-Württemberg are high. To better meet patients' needs, CAM research and physician education should be intensified. Trial registration: German Clinical Trial register (DRKS00015445). [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]

Aim To assess the association between nursing team continuity and quality of care. Background Research on nurse staffing and its effect on quality of care is investigated to different degrees. However, very few studies have observed whether the continuous deployment of nursing staff is associated with quality of care. Methods This study was conducted in two university neonatal intensive care units ( NICUs). We matched nurse schedule data for the NICUs with nursing-sensitive patient outcomes and quality of care, as perceived by parents. We used analysis of variance to analyse differences in nursing team continuity between NICUs and regression analyses to identify associations with the outcome measures. Results There were considerable differences between units in terms of team continuity of nursing staff. Positive associations were found between team continuity and a higher rate of non-invasive respiratory support as well as parents' perceptions of how well they knew their nurse. Conclusions The findings show remarkable differences in staff assignment in the different NICUs. In addition to appropriate staffing levels, scheduling nursing teams continuously would appear to play a role in influencing treatment quality. Implications for nursing management This paper emphasises the importance of carefully considered staff scheduling decisions. [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]

Purpose: The European 'Healthy Lifestyle in Europe by Nutrition in Adolescence' (HELENA) project evaluated two different approaches to harmonize the matching procedures between 24-h recall data and food composition databases. In the first approach, the 24-h recall data were linked to the local/national food composition databases using standardized procedures, while in the second approach, the 24-h recall data were linked to the German BLS database which includes a larger food list. The aim of this paper was to compare the intakes of energy and eight nutrient components calculated via both approaches. Methods: Two non-consecutive 24-h recalls were performed in 1268 adolescents. Energy, carbohydrates, proteins, fat, fiber, water, alcohol, calcium and vitamin C were calculated via the two approaches at individual level. Paired samples t test and Pearson's correlations were used to compare the mean intakes of energy and the eight mentioned nutrients and to investigate the possible associations between the two approaches. Results: Small but significant differences were found between the intakes of energy and the eight food components when comparing both approaches. Very strong and strong correlations (0.70-0.95) were found between both methods for all nutrients. Conclusion: The dietary intakes obtained via the two different linking procedures are highly correlated for energy and the eight nutrients under study. [ABSTRACT FROM AUTHOR]

Background: The Heidelberger Drogenbogen (HDB) is a German language assessment of substance-specific knowledge and consumption patterns of the illicit psychoactive substances cannabis, MDMA (ecstasy), amphetamines, cocaine, and hallucinogens. The behavior modules for each of these five drugs/drug groups allow for a diagnostic evaluation of the extent of harmful consumption behavior. Each of the five modules represents a single standardized test. Objectives: This paper outlines several statistical parameters, Cronbach's alpha, retest reliabilities, as well as numerous validity and cut-off-criteria of the behavioral modules. Methods: Participants (N = 4,794) were recruited at schools, universities, in subcultural contexts, and in institutions of substance abuse treatment. Results: Internal consistencies range from =.68 to.79 while test–retest reliabilities between.87 and.94 were found. The behavior modules of the HDB can discriminate between populations with and without clinical levels of substance use. Furthermore, this measure has incremental validity and higher diagnostic accuracy over competing measures. Conclusions: The behavior modules of the HDB are reliable and valid measures of substance use and misuse. [ABSTRACT FROM AUTHOR]

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

This paper focusses on coping strategies employed by children and adolescents with diagnosed short stature, assesses the impact of socio-demographic and clinical characteristics on coping, examines the relationship between coping and health related quality of life (QoL) and investigates the role of coping strategies in mediating the relationship between height and QoL. Coping with a disease (CODI) and quality of life in short stature youth (QoLISSY-QoL) questionnaires were completed by 137 short-statured children and adolescents between 8 and 18 years, participating in the crosssectional European QoLISSY study. Clinical and socio-demographic data were collected to examine differences in coping via variance and regression analyses, associations between CODI and QoLISSY were inspected using correlation and mediation analyses. Most frequently employed coping strategies in the CODI were 'Acceptance' and 'Wishful Thinking', with 'Emotional Reaction' used least. Significant effects of age, diagnosis and treatment status on coping strategies were detected. CODI scales 'Acceptance' and 'Distance' were associated with higher QoLISSY-QoL scores, 'Emotional Reaction' and 'Wishful Thinking' with lower scores. Coping strategies predicted 60 % of the QoLISSY-QoL variance. Relationships between height deviation and QoLISSY-QoL were mediated by the coping strategies of 'Wishful Thinking' and 'Distance'. Findings suggest that coping efforts vary with socio-demographic and clinical characteristics, that protective coping strategies in terms of QoL can be identified and that coping mediates the relationship between short stature and QoL. Future longitudinal research should focus on the adaptive function of coping in relation to QoL over time. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity is a common phenomenon in primary care. Until now, no clinical guidelines for multimorbidity exist. For the development of these guidelines, it is necessary to know whether or not patients are aware of their diseases and to what extent they agree with their doctor. The objectives of this paper are to analyze the agreement of self-reported and general practitioner-reported chronic conditions among multimorbid patients in primary care, and to discover which patient characteristics are associated with positive agreement. Methods: The MultiCare Cohort Study is a multicenter, prospective, observational cohort study of 3,189 multimorbid patients, ages 65 to 85. Data was collected in personal interviews with patients and GPs. The prevalence proportions for 32 diagnosis groups, kappa coefficients and proportions of specific agreement were calculated in order to examine the agreement of patient self-reported and general practitioner-reported chronic conditions. Logistic regression models were calculated to analyze which patient characteristics can be associated with positive agreement. Results: We identified four chronic conditions with good agreement (e.g. diabetes mellitus κ = 0.80;PA = 0,87), seven with moderate agreement (e.g. cerebral ischemia/chronic stroke κ = 0.55;PA = 0.60), seventeen with fair agreement (e.g. cardiac insufficiency κ = 0.24;PA = 0.36) and four with poor agreement (e.g. gynecological problems κ = 0.05;PA = 0.10). Factors associated with positive agreement concerning different chronic diseases were sex, age, education, income, disease count, depression, EQ VAS score and nursing care dependency. For example: Women had higher odds ratios for positive agreement with their GP regarding osteoporosis (OR = 7.16). The odds ratios for positive agreement increase with increasing multimorbidity in almost all of the observed chronic conditions (OR = 1.22-2.41). Conclusions: For multimorbidity research, the knowledge of diseases with high disagreement levels between the patients’ perceived illnesses and their physicians’ reports is important. The analysis shows that different patient characteristics have an impact on the agreement. Findings from this study should be included in the development of clinical guidelines for multimorbidity aiming to optimize health care. Further research is needed to identify more reasons for disagreement and their consequences in health care. Trial registration: ISRCTN89818205. [ABSTRACT FROM AUTHOR]

Recognizing the ageing of populations and expected increase in prevalence of dementia, the necessity of research involving persons with dementia is widely agreed upon. Autonomy is key to nursing home residents' well-being and quality of life, but this phenomenon has not been thoroughly assessed from the residents' perspective. The aim of this cross-sectional study was to investigate perceived autonomy of nursing home residents. Data on 560 randomly selected residents in 40 nursing homes in two German federal states were generated by face-to-face interviews, psychological and physical assessments, analysis of nursing records, and acquisition of institutional parameters. This paper reports on a subsample ( n = 179) that met screening requirements, including subjects with and without mild cognitive impairment ( Mini Mental Status Examination score 30-18), who completed the Hertz Perceived Enactment of Autonomy Scale ( HPEAS). The mean score of HPEAS was 101.1 ± 14.5 (range 54-122). In our population, Cronbach's alpha was 0.89. Scores in HPEAS were not related to demographical factors but positively associated with increasing self-efficacy and absence of pain. The novel findings contribute to an understanding of autonomy from the residents' perspective. [ABSTRACT FROM AUTHOR]

This paper reports the result of the MEDAN project that analyzes a multicenter septic shock patient data collection. The mortality prognosis based on 4 scores that are often used is compared with the prognosis of a trained neural network. We built an alarm system using the network classification results. Method. We analyzed the data of 382 patients with abdominal septic shock who were admitted to the intensive care unit (ICU) from 1998 to 2002. The analysis includes the calculation of daily sepsis-related organ failure assessment (SOFA), Acute Physiological and Chronic Health Evaluation (APACHE) II, simplified acute physiology score (SAPS) II, multiple-organ dysfunction score (MODS) scores for each patient and the training and testing of an appropriate neural network. Results. For our patients with abdominal septic shock, the analysis shows that it is not possible to predict their individual fate correctly on the day of admission to the ICU on the basis of any current score. However, when the trained network computes a score value below the threshold during the ICU stay, there is a high probability that the patient will die within 3 days. The trained neural network obtains the same outcome prediction performance as the best score, the SOFA score, using narrower confidence intervals and considering three variables only: systolic blood pressure, diastolic blood pressure and the number of thrombocytes. We conclude that the currently best available score for abdominal septic shock may be replaced by the output of a trained neural network with only 3 input variables. [ABSTRACT FROM PUBLISHER]

Background: Recent years have seen growing awareness of the importance of human resources for health in health systems and with it an intensifying of the international and national policies in place to steer a response. This paper looks at how governments and donors in five countries - Cameroon, Indonesia, Malawi, Rwanda and Tanzania - have translated such policies into action. More detailed information with regard to initiatives of German development cooperation brings additional depth to the range and entry doors of human resources for health initiatives from the perspective of donor cooperation. Methods: This qualitative study systematically presents different approaches and stages to human resources for health development in a cross-country comparison. An important reference to capture implementation at country level was grey literature such as policy documents and programme reports. In-depth interviews along a predefined grid with national and international stakeholders in the five countries provided information on issues related to human resources for health policy processes and implementation. Results: All five countries have institutional entities in place and have drawn up national policies to address human resources for health. Only some of the countries have translated policies into strategies with defined targets and national programmes with budgets and operational plans. Traditional approaches of supporting training for individual health professionals continue to dominate. In some cases partners have played an advocacy and technical role to promote human resources for health development at the highest political levels, but usually they still focus on the provision of ad hoc training within their programmes, which may not be in line with national human resources for health development efforts or may even be counterproductive to them. Countries that face an emergency, such as Malawi, have intensified their efforts within a relatively short time and by using donor funding support also through new initiatives such as the Global Fund to Fight AIDS, Tuberculosis and Malaria. Conclusion: The country case studies illustrate the range of initiatives that have surged in recent years and some main trends in terms of donor initiatives. Though attention and priority attributed to human resources for health is increasing, there is still a focus on single initiatives and programmes. This can be explained in part by the complexity of the issue, and in part by its need to be addressed through a long-term approach including public sector and salary reforms that go beyond the health sector. [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]

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

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

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]

Objective: The goal of this study was to investigate barriers to utilisation of cancer rehabilitation by querying a large sample of various professionals in health care with a comprehensive set of barriers. Methods: We developed a questionnaire comprising 55 barriers to utilisation of cancer rehabilitation and administered it to four different types of medical, care and social work experts involved in the referral to cancer rehabilitation. An exploratory factor analysis was conducted and the extracted factors were ranked by mean values. Additionally, ANOVAs were calculated to test for group differences. Results: Our sample (N = 606) consisted of 249 physicians, 194 social workers, 105 nurses and 55 psychologists in Germany. We identified seven barrier‐dimensions: low appreciation of rehabilitation by professionals, insufficient coordination, insufficient application procedure, rehabilitation requirements not met, patients' unfulfilled demands, patients' social responsibilities and patients' coping style, with the latter being rated as the most obstructive thereof. Furthermore, we found statistically significant group differences for six of these factors with small‐ to medium‐sized effects. Conclusion: Our results support previous publications implicating the patients' coping style as a barrier. We furthermore found evidence for barriers relating to processes and organisational issues, thereby expanding on the scope of patient‐oriented publications. Suggestions for improving patients' health services accessibility are made. [ABSTRACT FROM AUTHOR]

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Background. Much work has been done to evaluate the outcome of integrative inpatient treatment but scarcely the costs. This paper evaluates the costs for inpatient treatment in three anthroposophic hospitals (AHs). Material and Methods. Cost and performance data from a total of 23,180 cases were analyzed and compared to national reference data. Subgroup analysis was performed between the cases with and without anthroposophic medical complex (AMC) treatment. Results. Costs and length of stay in the cases without AMC displayed no relevant differences compared to the national reference data. In contrast the inlier cases with AMC caused an average of € 1,394 more costs. However costs per diem were not higher than those in the national reference data. Hence, the delivery of AMC was associated with a prolonged length of stay. 46.6% of the cases with AMC were high outliers. Only 10.6% of the inlier cases with AMC were discharged before reaching the mean length of stay of each DRG. Discussion. Treatment in an AH is not generally associated with an increased use of resources. However, the provision of AMC leads to a prolonged length of stay and cannot be adequately reimbursed by the current G-DRG system. Due to the heterogeneity of the patient population, an additional payment should be negotiated individually. [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]

Purpose: Thorough knowledge of the nature and frequency of co-infections is essential to optimize treatment strategies and risk assessment in cases of coronavirus disease 2019 (COVID-19). This study aimed to evaluate the multiplex polymerase chain reaction (PCR) screening approach for community-acquired bacterial pathogens (CABPs) at hospital admission, which could facilitate identification of bacterial co-infections in hospitalized COVID-19 patients. Methods: Clinical data and biomaterials from 200 hospitalized COVID-19 patients from the observational cohort of the Competence Network for community-acquired pneumonia (CAPNETZ) prospectively recruited between March 17, 2020, and March 12, 2021 in 12 centers in Germany and Switzerland, were included in this study. Nasopharyngeal swab samples were analyzed on hospital admission using multiplex real-time reverse transcription (RT)-PCR for a broad range of CABPs. Results: In total of 200 patients Staphylococcus aureus (27.0%), Haemophilus influenzae (13.5%), Streptococcus pneumoniae (5.5%), Moraxella catarrhalis (2.5%), and Legionella pneumophila (1.5%) were the most frequently detected bacterial pathogens. PCR detection of bacterial pathogens correlated with purulent sputum, and showed no correlation with ICU admission, mortality, and inflammation markers. Although patients who received antimicrobial treatment were more often admitted to the ICU and had a higher mortality rate, PCR pathogen detection was not significantly related to antimicrobial treatment. Conclusion: General CABP screening using multiplex PCR with nasopharyngeal swabs may not facilitate prediction or identification of bacterial co-infections in the early phase of COVID-19-related hospitalization. Most patients with positive PCR results appear to be colonized rather than infected at that time, questioning the value of routine antibiotic treatment on admission in COVID-19 patients. [ABSTRACT FROM AUTHOR]

Background: Unplanned emergency department (ED) visits of nursing home residents (NHR) are common, with many transfers not leading to hospitalization. However, there is little research on what diagnostic and therapeutic measures are performed during visits. Aims: We analyzed underlying diagnoses, characteristics and performed medical procedures of unplanned outpatient ED visits by NHR. Methods: We conducted a multi-center study of 14 nursing homes (NHs) in northwestern Germany in 03/2018–07/2019. Hospital transfers were documented by nursing staff using a standardized questionnaire for 12 months. In addition, discharge letters were used to collect information about the respective transfer, its reasons and the extend of the medical services performed in the ED. Results: A total of 161 unplanned ED visits were included (mean age: 84.2 years; 68.3% females). The main transfer reasons were trauma (59.0%), urinary catheter and nutritional probe problems (overall 10.6%; male NHR 25.5%) and altered mental state (9.9%). 32.9% where discharged without imaging or blood test prior. 67.4% of injured NHR (n = 95) required no or only basic wound care. Catheter-related problems (n = 17) were mainly treated by changing an existing suprapubic catheter (35.3%) and by flushing the pre-existing catheter (29.4%). Discussion: Our data suggest that the diagnostic and therapeutic interventions performed in ED, often do not exceed general practitioner (GP) care and many ED visits seem to be unnecessary. Conclusion: Better coordination and consultation with GPs as well as better training of nursing staff in handling catheter problems could help to reduce the number of ED visits. [ABSTRACT FROM AUTHOR]

Objective: We investigated the health‐related quality of life (HRQoL) of patients with gastrointestinal stromal tumours (GIST). Methods: In the multicentre PROSa study, the HRQoL of adult GIST patients was assessed between 2017 and 2019 using the European Organisation for Research and Treatment of Cancer HRQoL questionnaire (EORTC QLQ‐C30). We performed group comparisons and multivariate linear regressions. Results: Among 130 patients from 13 centres, the mean global HRQoL was 63.3 out of 100 points. Higher sores indicate better HRQoL. The highest restrictions were in emotional, social, role functioning, insomnia, fatigue, and pain. In multivariate linear regression, we found no significant differences between patients receiving tyrosine kinase inhibitor (TKI) treatment and those without TKI treatment as well as between patients treated with curative or with palliative intent. Patients who received multiple lines of TKI treatment had the most restrictions, notably in physical (unstandardized regression coefficient [B] = −15.7), role (B = −25.7), social (B = −18.4), and cognitive functioning (B = −19.7); fatigue (B = 15.93); general health (B = −14.23); and EORTC‐sum score (B = −13.82) compared to all other patients. Conclusion: The highest HRQoL restrictions were in GIST patients receiving multiple lines of TKI therapy. Underlying causes need further investigation. [ABSTRACT FROM AUTHOR]

Background The Aspergillus Galactomannan Lateral Flow Assay (LFA) is a rapid test for the diagnosis of invasive aspergillosis (IA) that has been almost exclusively evaluated in patients with hematologic malignancies. An automated digital cube reader that allows for quantification of results has recently been added to the test kits. Methods We performed a retrospective multicenter study on bronchoalveolar lavage fluid (BALF) samples obtained from 296 patients with various underlying diseases (65% without underlying hematological malignancy) who had BALF galactomannan (GM) ordered between 2013 and 2019 at the University of California, San Diego, the Medical University of Graz, Austria, and the Mannheim University Hospital, Germany. Results Cases were classified as proven (n = 2), probable (n = 56), putative (n = 30), possible (n = 45), and no IA (n = 162). The LFA showed an area under the curve (AUC) of 0.865 (95% confidence interval [CI].815–.916) for differentiating proven/probable or putative IA versus no IA, with a sensitivity of 74% and a specificity of 83% at an optical density index cutoff of 1.5. After exclusion of GM as mycological criterion for case classification, diagnostic performance of the LFA was highly similar to GM testing (AUC 0.892 vs 0.893, respectively). LFA performance was consistent across different patient cohorts and centers. Conclusions In this multicenter study the LFA assay from BALF demonstrated good diagnostic performance for IA that was consistent across patient cohorts and locations. The LFA may serve a role as a rapid test that may replace conventional GM testing in settings where GM results are not rapidly available. [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]

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