Search

Background: Masculinity norms play a crucial role in men's help-seeking behaviors, service-use, and coping strategies for depression. While previous studies provided evidence for the association between gender role orientations, work related attitudes, stigmatization of men with depression and depressive symptoms, it remains unclear to what extent gender role orientations change over time and whether psychiatric and psychotherapeutic treatment have an impact on these transformations. Additionally, the role of partners in supporting depressed men and the impact of dyadic coping on these processes have not been explored. The aim of this study is to investigate how masculinity orientations and work-related attitudes change over time in men treated for depression, and to examine the role of their partners and dyadic coping in these transformation processes. Methods: TRANSMODE is a prospective longitudinal mixed-methods study investigating the transformation of masculinity orientations and work-related attitudes in men treated for depression between the ages of 18 and 65 from different settings in Germany. The study will recruit 350 men from various settings for quantitative analysis. By applying a latent transition analysis, the primary outcome are changes in masculine orientations and work-related attitudes over time, measured at four times (t0, t1, t2, t3) with intervals of 6 months. Qualitative interview with a subsample of depressed men selected using latent profile analysis, will be conducted between t0 and t1 (a1) with a follow-up of 12 months (a2). In addition, qualitative interviews with the partners of depressed men will be conducted between t2 and t3 (p1). Qualitative data will be analysed using qualitative structured content analysis. Discussion: A comprehensive understanding of the transformation processes of masculinity orientations over time including the impact of psychiatric/psychotherapeutic treatment and the role of partners can lead to the development of gender-sensitive depression treatment tailored to the unique needs of men with depression. Thus, the study can promote more effective and successful treatment outcomes and further contribute to reducing the stigma surrounding mental health issues among men and encourage them for mental health service use. Trial registration: This study is registered in the German Clinical Trail Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00031065 (Date of registration 06 February 2023). [ABSTRACT FROM AUTHOR]

Background: Interruption of transmission chains has been crucial in the COVID-19 response. The Emergency Operations Centre (EOC) at the Robert Koch Institute (RKI) coordinated cross-border case and contact tracing activities at the national level by sharing data with German public health authorities (PHA) and other countries. Data on these activities were not collected in the national surveillance system, and thus were challenging to quantify. Our aim was to describe cross-border COVID-19 case and contact tracing activities including lessons learnt by PHA to adapt the procedures accordingly. Methods: Case and contact tracing events were recorded using unique identifiers. We collected data on cases, contacts, dates of exposure and/or SARS-CoV-2 positive test results and exposure setting. We performed descriptive analyses of events from 06.04.-31.12.2020. We conducted interviews with PHA to understand experiences and lessons learnt, applying a thematic approach for qualitative analysis. Results: From 06.04.-31.12.2020 data on 7,527 cross-border COVID-19 case and contact tracing activities were collected. Germany initiated communication 5,200 times, and other countries 2,327 times. Communication from other countries was most frequently initiated by Austria (n = 1,184, 50.9%), Switzerland (n = 338, 14.5%), and the Netherlands (n = 168, 7.2%). Overall, 3,719 events (49.4%) included information on 5,757 cases (median 1, range: 1–42), and 4,114 events (54.7%) included information on 13,737 contacts (median: 1, range: 1–1,872). The setting of exposure was communicated for 2,247 of the events (54.6%), and most frequently included private gatherings (35.2%), flights (24.1%) and work-related meetings (20.3%). The median time delay between exposure date and contact information receipt at RKI was five days. Delay between positive test result and case information receipt was three days. Main challenges identified through five interviews were missing data or delayed accessibility particularly from flights, and lack of clear and easy to use communication channels. More and better trained staff were mentioned as ideas for improving future pandemic response preparedness. Conclusion: Cross-border case and contact tracing data can supplement routine surveillance but are challenging to measure. We need improved systems for cross-border event management, by improving training and communication channels, that will help strengthen monitoring activities to better guide public health decision-making and secure a good future pandemic response. [ABSTRACT FROM AUTHOR]

Background: Similar to many other countries, in Germany patients with alcohol-related liver disease are obliged to prove their abstinence before being accepted on a waitlist for liver transplantation. Health care professionals (HCPs) must both treat patients and ensure that patients have proven their abstinence. The aim of this exploratory study was to develop a deeper understanding of how HCPs deal with this dual role. Methods: The study used semi-structured interviews as the source of data. 11 healthcare professionals from ten of the 22 German transplant centers were interviewed. After transcription, a qualitative content analysis was performed. Results: We found that these HCPs faced an ethical dilemma, as they must balance the roles of being both a treatment provider (the therapist role) and an assessor (the monitoring role). To solve this dilemma, the strategy seems to be a tendency for the HCPs to take on one dominant role amongst these two roles. HCPs who prefer to take on the therapist role seem to feel burdened by the 6-month abstinence rule and the obligation to monitor their patients. HCPs who prefer to take on the monitoring role tend to have negative assumptions about the patients. HCPs also reported the impression that patients perceive HCPs as more involved in monitoring and less open to the therapeutic role. From this it can be deduced that current regulations and structures lead both to stress for HCPs and to suboptimal therapy for those affected. Conclusions: The results showed that current transplantation guidelines can have a negative impact on both patient care and the burdens on the HCPs. From our point of view, there are various changes that could be made to the current clinical practice that would help solve this dilemma. For instance, integrating other assessment criteria that are more closely adapted to the health status trajectory and psychosocial background of the individual patient would be both possible and would lead to improvements in practice. [ABSTRACT FROM AUTHOR]

Background: In pediatric medical emergencies, paramedics and emergency physicians must often rely on the information of third parties, often caregivers, to gather information. Failing to obtain relevant information may lead to misinterpretation of symptoms and subsequent errors in decision making and clinical treatment. Thus, children and/or caregivers with limited proficiency of the locally spoken language may be at risk for medical errors. This study analyzes logs of rescue missions to determine whether paramedics could obtain essential information from German-speaking and foreign-language children and their caregivers. Methods: We conducted a secondary data analysis based on retrospective data on pediatric patients of four emergency medical services (EMS) stations in Northern Germany. We defined language discordance with communication difficulties as main exposure. We used documentation quality as outcome defined as existing information on (a) pre-existing conditions, (b) current medication, and (c) events prior to the medical emergency. Statistical analyses include descriptive statistics, simple regression and multivariable regression. As multivariable regression model, a logistic regression was applied with documentation quality as dependent variable and language discordance with communication difficulties as independent variable adjusted for age, sex and Glasgow Coma Scale (GCS). Results: Data from 1,430 pediatric rescue missions were analyzed with 3.1% (n = 45) having a language discordance with communication difficulties. Patients in the pediatric foreign-language group were younger compared to German-speaking patients. Thorough documentation was more frequent in German-speaking patients than in patients in the foreign-language group. Pre-existing conditions and events prior to the medical emergency were considerably more often documented in German-speaking than for foreign-language patients. Documentation of medication did not differ between these groups. The adjustment of sex, age and GCS in the multivariable analysis did not change the results. Conclusion: Language barriers are hindering paramedics to obtain relevant information in pediatric pre-hospital emergencies. This jeopardizes the safe provision of paramedic care to children who themselves or their caregivers are not fluent in German language. Further research should focus on feasible ways to overcome language barriers in pre-hospital emergencies. Trial registration: This is a retrospective secondary data analysis of a study that was registered at the German Clinical Trials Register (No. DRKS00016719), 08/02/2019. [ABSTRACT FROM AUTHOR]

Background: Multiple studies indicate that residents in family medicine (FM) are exposed to considerable stress and are particularly affected by burnout syndrome. Aim of the study was to specify the effects of a so-called "compact intervention" (i.e., a short intervention) in self-care on FM residents. Methods: The authors performed a concurrent and independent mixed-methods study with FM residents on the KWBW VerbundweiterbildungPLUS© program. FM residents could voluntarily take part in a two-day seminar including 270 min on self-care, which can be regarded as a compact intervention. Study participants completed a questionnaire before (T1) and ten to twelve weeks after the course (T2), with subsequent recruitment to interview. The main outcomes of the quantitative part were to evaluate (I) self-rated change of cognition and (II) change in behavior. The qualitative outcomes were all possible effects of the compact intervention on participants´ competencies as well as all sorts of induced behavioral changes. Results: From a total of n = 307 residents, n = 287 FM residents (intervention group: n = 212; control group: n = 75) participated in the study. At T2, 111 post-intervention questionnaires were completed. 56% rated the intervention to be helpful for their well-being (n = 63/111). At T2, there was a significant increase in those willing to act in comparison to T1 (p =.01): 36% (n = 40/111) had changed their behavior and half of the study participants had passed on competencies to others (n = 56/111). From the intervention group, n = 17 participants additionally gave an interview. FM residents favored a trustful learning atmosphere, an interactive teaching concept and practical exercises. They described an encouraging stimulus to act and specified behavioral changes. Conclusions: A compact intervention in self-care could increase well-being, foster competencies and induce behavioral changes, if implemented into a training program with sufficient group cohesiveness. Further studies are required to specify long-term-results. [ABSTRACT FROM AUTHOR]

Background: Patients with acute COVID-19 can develop persistent symptoms (long/post COVID-19 syndrome). This study aimed to project the economic, health care, and pension costs due to long/post-COVID-19 syndrome with new onset in Germany in 2021. Methods: Using secondary data, economic costs were calculated based on wage rates and the loss of gross value-added. Pension payments were determined based on the incidence, duration, and amount of disability pensions. Health care expenditure was calculated based on rehabilitation expenses. Results: The analysis estimated a production loss of 3.4 billion euros. The gross value-added loss was calculated to be 5.7 billion euros. The estimated financial burden on the health care and pension systems due to SARS-CoV-2 infection was approximately 1.7 billion euros. Approximately 0.4 percent of employees are projected to be wholly or partially withdrawn from the labor market in the medium term due to long/post-COVID with new onset in 2021. Conclusion: Costs of long/post-COVID-19 syndrome with new onset in 2021 are not negligible for the German economy and health care and pension systems but may still be manageable. [ABSTRACT FROM AUTHOR]

Background: Precision oncology, defined as treatment of patients with targeted therapies matched to specific molecular alterations, has entered routine clinical practice. Particularly in patients with advanced cancer or hematologic malignancies, for whom no further standard therapies are available, this approach is increasingly applied as last resort option outside of the approved indication. However, data on patient outcomes are not systematically collected, analyzed, reported, and shared. We have initiated the INFINITY registry to provide evidence from routine clinical practice to fill this knowledge gap. Methods: INFINITY is a retrospective, non-interventional cohort study conducted at approximately 100 sites in Germany (office-based oncologists/hematologists and hospitals). We aim to include 500 patients with advanced solid tumors or hematologic malignancies who received a non-standard targeted therapy based on potentially actionable molecular alterations or biomarkers. INFINITY aims to provide insights into the use of precision oncology in routine clinical practice within Germany. We systematically collect details on patient and disease characteristics, molecular testing, clinical decision-making, treatment, and outcome. Discussion: INFINITY will provide evidence on the current biomarker landscape driving treatment decisions in routine clinical care. It will also provide insights on effectiveness of precision oncology approaches in general, and of specific drug class/alteration matches used outside their approved indications. Trial registration: The study is registered at ClinicalTrials.gov, NCT04389541. [ABSTRACT FROM AUTHOR]

Objective: Hospitals are frequently associated with poor working conditions that can lead to work stress and increase the risk for reduced employee well-being. Managers can shape and improve working conditions and thereby, the health of their teams. Thus, as a prerequisite, managers need to be aware of their employees' stress levels. This study had two objectives: At first, it aimed to test the criterion validity of the Effort-Reward Imbalance (ERI) questionnaire measuring psychosocial workload in hospital employees. Secondly, mean scales of the ERI questionnaire filled in by employees were compared with mean scales of an adapted ERI questionnaire, in which managers assessed working conditions of their employees. Methods: Managers (n = 141) from three hospitals located in Germany assessed working conditions of their employees with an adapted external, other-oriented questionnaire. Employees (n = 197) of the mentioned hospitals completed the short version of the ERI questionnaire to assess their working conditions. Confirmatory factor analyses (CFA) were applied to test factorial validity, using the ERI scales for the two study groups. Criterion validity was assessed with multiple linear regression analysis of associations between ERI scales and well-being among employees. Results: The questionnaires demonstrated acceptable psychometric properties in terms of internal consistency of scales, although some indices of model fit resulting from CFA were of borderline significance. Concerning the first objective, effort, reward, and the ratio of effort-reward imbalance were significantly associated with well-being of employees. With regard to the second objective, first tentative findings showed that managers' ratings of their employees' effort at work was quite accurate, whereas their reward was overestimated. Conclusions: With its documented criterion validity the ERI questionnaire can be used as a screening tool of workload among hospital employees. Moreover, in the context of work-related health promotion, managers' perceptions of their employees' workload deserve increased attention as first findings point to some discrepancies between their perceptions and those provided by employees. [ABSTRACT FROM AUTHOR]

Background: Segmenting the population into homogenous groups according to their healthcare needs may help to understand the population's demand for healthcare services and thus support health systems to properly allocate healthcare resources and plan interventions. It may also help to reduce the fragmented provision of healthcare services. The aim of this study was to apply a data-driven utilisation-based cluster analysis to segment a defined population in the south of Germany. Methods: Based on claims data of one big German health insurance a two-stage clustering approach was applied to group the population into segments. A hierarchical method (Ward's linkage) was performed to determine the optimal number of clusters, followed by a k-means cluster analysis using age and healthcare utilisation data in 2019. The resulting segments were described in terms of their morbidity, costs and demographic characteristics. Results: The 126,046 patients were divided into six distinct population segments. Healthcare utilisation, morbidity and demographic characteristics differed significantly across the segments. The segment "High overall care use" comprised the smallest share of patients (2.03%) but accounted for 24.04% of total cost. The overall utilisation of services was higher than the population average. In contrast, the segment "Low overall care use" included 42.89% of the study population, accounting for 9.94% of total cost. Utilisation of services by patients in this segment was lower than population average. Conclusion: Population segmentation offers the opportunity to identify patient groups with similar healthcare utilisation patterns, patient demographics and morbidity. Thereby, healthcare services could be tailored for groups of patients with similar healthcare needs. [ABSTRACT FROM AUTHOR]

Background: Adequate health care in correctional facilities is often limited by staff shortage, which entails time-consuming consultations with physicians outside of these facilities. Video consultations (VC) have been implemented in many different health care settings and may also be useful in correctional facilities. As part of a pilot project, synchronous VC were implemented in five correctional facilities in Germany in June 2018. The aim of this study was to describe the implementation process from the providers' perspective and to identify factors promoting or inhibiting the implementation process of VC with a focus on interprofessional collaboration between nursing staff and telemedicine physicians. Methods: As part of the mixed-methods evaluation of the pilot project, site visits to the five correctional facilities were carried out. Nursing staff from the five correctional facilities (n=49) and telemedicine physicians (n=10) were asked to participate in interviews and a questionnaire survey. Interviews were analyzed using qualitative content analysis and questionnaires were evaluated using descriptive statistical methods. The results from both data sources were integrated and discussed in the framework of Normalization Process Theory. Results: Interviews were conducted with 24.5% (n=12) of nursing staff and 20.0% (n=2) of telemedicine physicians, while questionnaires were returned by 22.5% (n=11) of nursing staff and 33.3% (n=3) of telemedicine physicians. VC with general practitioners and psychiatrists were perceived as an additional support during times when physicians were absent from the correctional facilities. Allocating telemedicine physicians to specific correctional facilities might further improve interprofessional collaboration with nursing staff during VC. Inhibiting factors comprised the lack of integrating nursing staff into the implementation process, increased workload, insufficient training and the implementation of VC at an inconvenient time. Conclusions: To summarize, VC are a promising supplement to face-to-face health care in correctional facilities despite several limitations. These might be compensated by improving interprofessional cooperation and by integrating telemedicine physicians into local health care teams. [ABSTRACT FROM AUTHOR]

Background: The transition to parenthood represents a critical life period with psychosocial, and behavioral changes and challenges for parents. This often increases stress and leads to unhealthy weight gain in families, especially in psychosocially burdened families. Although universal and selective prevention programs are offered to families, specific support often fails to reach psychosocially burdened families. Digital technologies are a chance to overcome this problem by enabling a low-threshold access for parents in need. However, there is currently a lack of smartphone-based interventions that are tailored to the needs of psychosocially burdened families. Aims: The research project I-PREGNO aims to develop and evaluate a self-guided, smartphone-based intervention in combination with face-to-face counseling delivered by healthcare professionals for the prevention of unhealthy weight gain and psychosocial problems. The intervention is specifically tailored to the needs of psychosocially burdened families during the pregnancy and postpartum period. Methods: In two cluster randomized controlled trials in Germany and Austria (N = 400) psychosocially burdened families will be recruited and randomized to i) treatment as usual (TAU), or ii) I-PREGNO intervention (self-guided I-PREGNO app with counseling sessions) and TAU. We expect higher acceptance and better outcomes on parental weight gain and psychosocial stress in the intervention group. Discussion: The intervention offers a low cost and low-threshold intervention and considers the life situation of psychosocially burdened families who are a neglected group in traditional prevention programs. After positive evaluation, the intervention may easily be implemented in existing perinatal care structures in European countries such as Germany and Austria. Trial registration: Both trials were registered prospectively at the German Clinical Trials Register (Germany: DRKS00029673; Austria: DRKS00029934) in July and August 2022. [ABSTRACT FROM AUTHOR]

Background: Racism in medicine represents a global problem. It takes place on the individual, institutional and structural level. Especially structural racism can have serious effects on the health of individual people. Furthermore, racist discrimination is not always based on race solemnly but frequently intersects with other social categories such as gender, class or religion. To describe this multidimensional form of discrimination the term intersectionality has been coined. However, the understanding of structural intersectional racism in medicine is still fragmented, especially in the German context. Yet, medical students need to be trained in understanding structural and intersectional racism to see the impact of racist structures on the patient's health. Method: We conducted a qualitative study to explore the knowledge, awareness and perception of racism in medicine and health care of medical students in Germany. Our research questions are how do medical student understand structural racism and its effects on health in Germany? Do students see interrelations with other forms of discrimination and in this context to what extent are they familiar with the concept of intersectionality? Which categories intersect from their point of views with race in context of medicine and health care? We conducted focus groups with medical students (n = 32) in Germany. Results: Our results demonstrate that students have a wide spectrum of knowledge, awareness and perceptions about racism from being rather elaborate to very little knowledge about it. The students have particular problems to understand and situate structural racism in Germany. Some raised doubts about the relevance. Yet, other students are aware of the concept of intersectionality and are convinced that racism must be looked at from an intersectional perspective. Conclusions: The diverse knowledge, awareness and perceptions of medical students about structural racism and intersectionality hints to a lack of systematic education of medical students about these issues in Germany. Yet, in context of diversifying societies an understanding about racism and its impact on health is imminent for future medical doctors to provide good care for their patients. Therefore, this knowledge gap must be systematically filled by the medical education. [ABSTRACT FROM AUTHOR]

Introduction: Patients with Parkinson's Disease (PD) require an all-encompassing and individualized care including pharmacological as well as non-pharmacological treatment approaches, such as physical therapy, occupational therapy and speech and swallowing therapy. ParkinsonAKTIV is an innovative, multidisciplinary, and comprehensive approach to guide this non-pharmacological PD treatment in northwestern Germany. Its online communication platform called JamesAKTIV has been developed to enhance and standardize PD healthcare professionals' communication. The implementation of ParkinsonAKTIV and JamesAKTIV is accompanied through a detailed process evaluation and to gather evidence on the impact on patient-related outcomes, such as health-related quality of life and healthcare costs for people with PD through an effectiveness evaluation. Methods: The study design contains two parts: (1) first, a quantitative effectiveness evaluation is conducted utilizing a prospective quasi-experimental approach with a control group which examines PD patient's health-related quality of life and physician-assessed PD patient's health status (Unified Parkinson Disease Rating Scale). Moreover, a health economic evaluation of the ParkinsonAKTIV intervention is conducted using patient-reported outcomes and cost data as well as routine data from a statutory health insurance. (2) Second, a mixed-methods process evaluation among healthcare professionals, which examines the feasibility and potential barriers and facilitators of ParkinsonAKTIV for routine care, is performed. Quantitative results from a social network analysis and a survey among healthcare professionals will be triangulated with data from qualitative stakeholder interviews and focus group discussions. Perspective: Findings are expected to provide evidence of an increase in quality of life of patients with PD, less severe PD symptoms, and a better ability to participate in activities of daily living. ParkinsonAKTIV has the potential of increasing PD patients' quality of care through sufficient and more tailored prescription of non-pharmacological therapies. It is anticipated that ParkinsonAKTIV will improve communication among health professionals. Results from the ParkinsonAKTIV study will provide first practice-oriented evidence and a roadmap for implementation of an online tool for a comprehensive, multidisciplinary care PD network for patients and their caregivers in routine care in Germany. Trial registration ClinicalTrials.gov: registration number NCT05251298 (retrospectively registered: https://clinicaltrials.gov/ct2/show/record/NCT05251298). [ABSTRACT FROM AUTHOR]

Background: About 25% of all ischaemic strokes are related to cardio-embolism, most often due to atrial fibrillation (AF). Little is known about the extent and standardization of routine cardiac diagnostic work-up at certified stroke-units in Germany. Methods: The MonDAFIS study included non-AF patients with acute ischaemic stroke or transient ischaemic attack (TIA) at 38 certified stroke-units in Germany. Here, we analysed routine diagnostic work-up and disregarded study-related Holter-ECG monitoring. We compared duration of stroke-unit stay, number of 24-h Holter-ECGs, and echocardiography performed between university-based comprehensive stroke centres (UCSC, 12 hospitals, 1606 patients), non university-based comprehensive stroke centres (nUCSC, 14 hospitals, 892 patients), and primary stroke centres at non-university hospitals (PCS, 12 hospitals, 933 patients) using multivariable mixed regression analyses. Detection of a first AF episode in-hospital was also compared between hospitals of different stroke-unit levels. Results: In 3431 study patients (mean age 66.2 years, 39.5% female, median NIHSS = 2 on admission), median duration of the stroke-unit stay was 72 h (IQR 42–86). Stroke-unit stay was longer (categorised ≤ 24/ > 24- ≤ 72/ > 72 h) for patients with severe stroke (NIHSS score ≥ 5/ < 5: OR = 1.6, 95%CI 1.3–2.0) and for patients with ischaemic stroke vs. TIA (OR = 1.7, 95%CI 1.4–2.1). Overall, 2149/3396 (63.3%) patients underwent at least one additional 24-h Holter-ECG (median 1 [IQR 0–1], range 0–7). Holter-ECG rate was 47% in UCSC, 71% in nUCSC, and 84% in PCS. Compared to PCS, AF was less often detected in-hospital in UCSC (OR = 0.65, 95%CI 0.45–0.93) and nUCSC (OR = 0.69, 95%CI 0.46–1.04). Transoesophageal echocardiography (TEE) only was performed in 513/3391 (15.1%) study patients, transthoracic echocardiography (TTE) only in 1228/3391 (36.2%), and TEE combined with TTE in 1020/3391 (30.1%) patients. Patients younger than 60 years (vs. ≥ 60 years) underwent TEE more often than those older than 60 years (OR = 3.44, 95%CI 2.67–4.42). TEE (IQR 34–65%) and TTE rate (IQR 40–85%) varied substantially among study centres. Echocardiography rate (TTE and/or TEE) was 74.0% in UCSC, 85.4% in nUCSC, and 90.3% in PSC, respectively. Conclusions: In the MonDAFIS study, the routine use of echocardiography and Holter-ECG monitoring varied in participating stroke centres and at stroke-unit level, if grouped according to stroke-unit certification grade and hospitals´ university status. Trial registration Clinical Trials, NCT02204267. Registered 30 July 2014, https://clinicaltrials.gov/ct2/show/NCT02204267. [ABSTRACT FROM AUTHOR]

Background: Using a data set of works councils of trade union IG Metal, this paper investigates psychosocial stress and strain on this specific group in comparison to employees working in administration in general (leadership and non-leadership-role) and a national reference value. Methods: For assessing psychosocial work factors on works councils within the sector represented by the trade union IG Metal in Germany, a research by using the German standard version of COPSOQ (Copenhagen Psychosocial Questionnaire) was performed. The instrument includes 87 single items forming 25 aspects of strain and stress. Results from the study group of works councils were compared to those from employees working in administration and to the general population mean (COPSOQ database). Statistical analysis included t-tests, analysis of variance and multiple comparisons of means. To be significant in terms of statistics, p<0.05 (two-tailed) and a minimum deviation of 5 or more points between groups' mean values identify the relevant values. Results: All in all, 309 works councils from a national survey of the German chemical and metalworking industries took part in the study. 113 were full-time works council members (exempted from the duty to perform their regular work), 196 were voluntary members (acting as employee representatives on an honorary basis alongside their normal duties). Comparison between works councils and employees working in administration (leadership roles (N=1810) and non-leadership roles (N=2970)) and for employees in general (N=35.000) showed unfavourable values for works councils for most scales. Significantly higher values indicating higher strain and stress were found for the scales: emotional demands, work-privacy conflict, role conflicts, mobbing, cognitive stress symptoms and burnout. Unfavourable results were obtained for the aspects: quality of leadership, social support, sense of community and general health. Favourable findings were found on the scales: influence at work, quantity of social relations and the partly positive values for quantitative demands and commitment to the workplace. Conclusion: Compared to the reference groups, works council members perceive the psychosocial demands of working life as more exhausting for the majority of aspects. This allows several conclusions. One reason may be the extended tasks employee representatives face, another may be that the education of most works council members does not seem appropriate to the high demands of their managerial and executive tasks. [ABSTRACT FROM AUTHOR]

Background: To maintain patients' quality of life is one of the major goals in palliative home care provided by general practitioners (GPs). GPs need adequate training to care for palliative patients. The paper seeks to evaluate whether a specific training in Germany (PAMINO) has any improving impact on the care of palliative patients and their health-related quality of life. Methods: From September 2007 until June 2009, GPs and their palliative care patients with cancer participated in a study to evaluate palliative courses for GPs offered by a regional palliative care initiative (PAMINO). For a period of six months at most or until death, patients were asked monthly to judge their quality of life on the Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) of the European Organization for Research and Treatment of Cancer(EORTC) and on the Palliative Care Outcome Scale (POS). The 'Overall quality of life' scale of the QLQ-C15-PAL takes values between 0 and 100 with higher values indicating a higher quality of life. The POS sum scale takes values between 0 and 40 with higher values indicating worse care outcomes. Patients cared for by PAMINO-trained GPs and patients cared for by other GPs (control group) are compared using t-tests for differences in group means. Results: One hundred patients participated in the study; 96 patients filled out the questionnaires at least once. On the QLQ-C15-PAL, mean quality of life of the patient groups of PAMINO-trained and other GPs were 37.7 (SD = 25.5)and 39.4 (SD = 26.3) (p = .76), respectively. On the POS, respective mean values of 13.6 (SD = 5.8) and 12.0 (SD = 6.5)(p = .26) were given. Patients cared for by a PAMINO-trained GP did not report better quality of life and care outcomes than patients cared for by other general practitioners. Conclusions: Patients cared for by PAMINO-trained and other GPs in our study did not report differences in quality of life. Quality of life and care outcomes of all patients were better than of palliative patients in institutional or specialized care, emphasizing the ability of GPs to provide adequate care for these vulnerable patients. However, conclusions need to be drawn cautiously since the study had a small sample size [ABSTRACT FROM AUTHOR]

Background: Parental palliative disease is a family affair, however adolescent's well-being and coping are still rarely considered. The objectives of this paper were a) to identify differences in psychosocial adjustment and health-related quality of life (HRQoL) among adolescents and young adults with parents suffering from palliative cancer or cancers in other disease stages, b) to relate psychosocial adjustment and health-related quality of life to adolescent coping, and c) to explore significant mediator and predictor variables. Methods: Cross-sectional data were derived from a multi-site research study of families before child-centered counselling. N=86 adolescents and young adults were included, their mean age 13.78 years (sd 2.45), 56% being female. Performed analyses included ANCOVA, multiple linear regression, and mediation analysis. Results: Adolescents with parents suffering from palliative cancers reported significantly less total psychosocial problems, and better overall HRQoL. There were no significant group differences regarding coping frequency and efficacy. Our set of coping items significantly mediated the effect of parental disease stage on psychosocial problems and HRQoL. Further, parental disease status and general family functioning predicted psychosocial problems (R2adj =.390) and HRQoL (R2adj =.239) best. Conclusion: The study indicates distress among adolescents throughout the entire parental disease process. Our analysis suggests that counselling services could offer supportive interventions which focus particularly on adolescent coping as well as family functioning. [ABSTRACT FROM AUTHOR]

Background: Governmental funding support is seen as a prerequisite for the growth of research in general practice. Several funding programs in the amount of € 13.2 Mio were introduced in Germany from 2002 to February 2012. We aim to provide an overview of publications reporting original data and systematic reviews from German academic family medicine published between 2000 and 2010. Methods: Publications were identified by searching the database Scopus and screening publication lists of family medicine divisions or institutes. Papers had to report original primary research studies or systematic reviews; at least one of the authors had to be affiliated to a German academic family medicine division or institute. Results: 794 articles were included. The number of publications increased steadily starting from 107 in the period from 2000 to 2003, to 273 from 2004 to 2007, and finally to 414 from 2008 to 2010. Less than 25% were published in English in the first period. This proportion increased to 60.6% from 2008 to 2010. Articles published in a journal without impact factor decreased from 59.8% to 31.9%. Nevertheless, even in the most recent period only 31.6% of all articles were published in a journal with an impact factor above 2. The median impact factor increased from 0 in the first period to 1.2 in the last. Conclusions: The output of original research publications from academic research divisions and institutes for general practice in Germany greatly increased during the last decade. However, professionalism of German primary care research still needs to be developed. [ABSTRACT FROM AUTHOR]

The article focuses on a research paper which evaluates the medical practice in pediatric computed tomography (CT) referrals, a major source of ionizing radiation exposure in medical diagnostics. The cross-sectional study also examines the physicians' knowledge of radiation doses and health associated with CT in children.

Background: SOLAR II is the 2nd follow-up of a population-based cohort study that follows the participants of ISAAC Phase Two recruited in Munich and Dresden in 1995/6. A first follow-up study was conducted 2002 and 2003 (SOLAR I). The aims of SOLAR II were to investigate the course of atopic diseases over puberty taking environmental and occupational risk factors into account. This paper describes the methods of the 2nd follow-up carried out from 2007 to 2009 and the challenges we faced while studying a population-based cohort of young adults. Methods: Wherever possible, the same questionnaire instruments were used throughout the studies. They included questions on respiratory and allergic diseases, domestic and occupational exposure and work related stress. Furthermore, clinical examinations including skin prick tests, spirometry and bronchial challenge with methacholine, exhaled nitric oxide (FeNO) and blood samples were employed at baseline and 2nd follow-up. As information from three studies was available, multiple imputation could be used to handle missing data. Results: Of the 3053 SOLAR I study participants who had agreed to be contacted again, about 50% had moved in the meantime and had to be traced using phone directories and the German population registries. Overall, 2904 of these participants could be contacted on average five years after the first follow-up. From this group, 2051 subjects (71%) completed the questionnaire they received via mail. Of these, 57% participated at least in some parts of the clinical examinations. Challenges faced included the high mobility of this age group. Time constraints and limited interest in the study were substantial. Analysing the results, selection bias had to be considered as questionnaire responders (54%) and those participating in the clinical part of the study (63%) were more likely to have a high parental level of education compared to non-participants (42%). Similarly, a higher prevalence of parental atopy (e. g. allergic rhinitis) at baseline was found for participants in the questionnaire part (22%) and those participating in the clinical part of the study (27%) compared to non-participants (11%). Conclusions: In conclusion, a 12-year follow-up from childhood to adulthood is feasible resulting in a response of 32% of the baseline population. However, our experience shows that researchers need to allocate more time to the field work when studying young adults compared to other populations. [ABSTRACT FROM AUTHOR]

The OBML 2010 workshop, held at the University of Mannheim on September 9-10, 2010, is the 2nd in a series of meetings organized by the Working Group "Ontologies in Biomedicine and Life Sciences" of the German Society of Computer Science (GI) and the German Society of Medical Informatics, Biometry and Epidemiology (GMDS). Integrating, processing and applying the rapidly expanding information generated in the life sciences — from public health to clinical care and molecular biology — is one of the most challenging problems that research in these fields is facing today. As the amounts of experimental data, clinical information and scientific knowledge increase, there is a growing need to promote interoperability of these resources, support formal analyses, and to pre-process knowledge for further use in problem solving and hypothesis formulation. The OBML workshop series pursues the aim of gathering scientists who research topics related to life science ontologies, to exchange ideas, discuss new results and establish relationships. The OBML group promotes the collaboration between ontologists, computer scientists, bio-informaticians and applied logicians, as well as the cooperation with physicians, biologists, biochemists and biometricians, and supports the establishment of this new discipline in research and teaching. Research topics of OBML 2010 included medical informatics, Semantic Web applications, formal ontology, bio-ontologies, knowledge representation as well as the wide range of applications of biomedical ontologies to science and medicine. A total of 14 papers were presented, and from these we selected four manuscripts for inclusion in this special issue. An interdisciplinary audience from all areas related to biomedical ontologies attended OBML 2010. In the future, OBML will continue as an annual meeting that aims to bridge the gap between theory and application of ontologies in the life sciences. The next event emphasizes the special topic of the ontology of phenotypes, in Berlin, Germany on October 6-7, 2011. [ABSTRACT FROM AUTHOR]

Background: Children with a low socioeconomic position are more affected by mental difficulties as compared to children with a higher socioeconomic position. This paper explores whether this socioeconomic pattern persists in the prosperous German city of Munich which features high quality of life and coverage of children mental health specialists that lies well above the national average and is among the highest in Europe.Methods: 1,265 parents of preschool children participated in a cross-sectional health survey. They were given a self-administered questionnaire (including socioeconomic variables) and the 'Strengths and Difficulties Questionnaire (SDQ)', a well-established method to identify mental difficulties among children and adolescents. Prevalence estimates for the 'SDQ-Total Difficulties Score' were calculated, with a special focus on differences by parental (resp. household) socioeconomic position. The association between parental education, household income, single parenthood, nationality, and parental working status on one hand, and their children's mental health on the other, was explored using multivariable logistic regression models. The coverage of mental health specialists per 100,000 children aged 14 or younger in the city of Munich was also calculated.Results: In Munich, the distribution of mental health difficulties among children follows the same socioeconomic pattern as described previously at the national level, but the overall prevalence is about 30% lower. Comparing different indicators of socioeconomic position, low parental education and household income are the strongest independent variables associated with mental difficulties among children (OR = 2.7; CI = 1.6 - 4.4 and OR = 2.8; CI = 1.4 - 5.6, respectively).Conclusions: Socioeconomic differences in the prevalence of childhood mental difficulties are very stable. Even in a city such as Munich, which is characterized by high quality of life, high availability of mental health specialists, and low overall prevalence of these mental difficulties, they are about as pronounced as in Germany as a whole. It can be concluded that the effect of several characteristics of socioeconomic position 'overrules' the effect of a health promoting regional environment. [ABSTRACT FROM AUTHOR]

Background: Henrich Klebahn was a German linguist, mycologist and phytopathologist, who was known as Dr. Dr. h. c. Henrich Klebahn, Hauptcustos a. D., Honorarprofessor an der Hanischen Universität. He was born February 20, 1859 in Bremen, and died October 5, 1942 in Hamburg. He taught linguistics from 1885-1899, studied Natural Science at the Universities of Jena and Berlin (1881) and received his PhD from the University of Jena. In 1899, he was appointed scientific assistant at the Hamburg botanical garden, where he worked until 1905. From 1905 to 1930, he was at the agricultural institute of Bromberg. In 1921, he was named honorary professor and lecturer in cryptogams and soil biology at the Institut für Allgemeine Botanik where he taught until 1934. He is well known for his work on gas vesicles and halophiles, among other topics. This re-print of 'Die Schädlinge des Klippfisches. Ein Beitrag zur Kenntnis der salzliebenden Organismen. Von H. Klebahn. Mit zwei Tafeln und vier Abbildungen im Text.' was originally published in 1919 in the Jahrbuch der Hamb. Wissensch. Anstaltes. XXXVI. Beiheft pages 11-69, by Latcke & Waltt, E. H. Buchdrucker. The translators have tried to remain faithful to the contents and to the original sense of the article by minimizing modifications. Results: The original paper reported the conclusions of a 3 year long study of the microbes causing damage to the fish industry as well as a summation of work on the subject up until 1919. The findings were that the causative agents were fungi and other microbes, the chief of which was a red, Gram-negative rod-shaped bacillus, Bacillus halobius ruber, that formed pale reddish colonies and was found to oscillate, but after extensive testing, was found not possess flagella. The initial appearance of "a shiny corpuscle" at the ends of cells was determined not to be spores; rather that it was the "result of the coherence of the light beams due to a total reflection of the light in the optically denser little rods". The cells were osmotically sensitive to the addition of water. In addition, a Gram-negative, red Sarcina morrhuae that appeared pinker in color, was less salt-sensitive than the red bacillus, in fact surviving the transfer to water. These were "round individual cells or groups of only two or four cells, usually; however, there are eight or more round cells that are arranged like cube corners to great cube-like or irregular packages lying together, just in the same manner as with the familiar Sarcina ventriculi." This organism was also identified from the walls of a fish storage room. Finally, a third, red microorganism was isolated: a Gram-negative micrococcus, Micrococcus (Diplococcus) morrhuae, which was "spherically rounded" and barely sensitive to water: "If one distributes a sample of a colony in water, the cells partly separate, to a great degree; however, they stay together in groups of two or four cells." Conclusions: This article provides evidence for identification of halophilic microbes as the major cause of fish spoilage, and is one of the earliest publications in the field of halophile microbiology. [ABSTRACT FROM AUTHOR]

Background: Specialist palliative care is being increasingly recognised and developed to improve end-of-life care in many developed countries. However, only a small proportion of the total number of patients with incurable, progressive diseases actually has direct contact with specialist palliative care practitioners. Using the German situation as an example, the main purpose of this paper is to argue that the emphasis on specialist palliative care services without a similar encouragement of primary palliative care will deliver a constrained service. Discussion: For the vast majority of people with incurable, progressive diseases, good palliative care delivered by General Practitioners and community nurses, with access to specialist support when needed, is the optimal response. In Germany, specialist palliative care in the community was established in the 2007 health care reforms. However actual and potential delivery of palliative care by general practitioners and community based nurses has been sorely neglected. The time-consuming care of palliative patients and their families is currently far from accurately reflected in German, indeed most European primary care payment systems. However, it is not just a question of adequate financial compensation but also of the recognition of the fundamental value of this intense form of holistic family medicine. Summary: It is imperative palliative care carried out by community nurses and general practitioners is better recognised by health professionals, health insurers, government and the scientific community as a central part of the delivery of health care for people in the last phase of life. Health systems should be arranged so that this critical role of general practice and primary care is intentionally fostered. Palliative care carried out by generalists needs an identity at an academic and practical level, developing in concert with specialist palliative care. [ABSTRACT FROM AUTHOR]

Background: The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design: The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion: The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. [ABSTRACT FROM AUTHOR]

Background: Obesity among children and adolescents is a growing public health problem. The aim of the present paper is to identify potential determinants of obesity and risk groups among 3- to 17-year old children and adolescents to provide a basis for effective prevention strategies. Methods: Data were collected in the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a nationally representative and comprehensive data set on health behaviour and health status of German children and adolescents. Body height and weight were measured and body mass index (BMI) was classified according to IOTF cut-off points. Statistical analyses were conducted on 13,450 non-underweight children and adolescents aged 3 to 17 years. The association between overweight, obesity and several potential determinants was analysed for this group as well as for three socio-economic status (SES) groups. A multiple logistic regression model with obesity as the dependent variable was also calculated. Results: The strongest association with obesity was observed for parental overweight and for low SES. Furthermore, a positive association with both overweight (including obesity) and obesity was seen for maternal smoking during pregnancy, high weight gain during pregnancy (only for mothers of normal weight), high birth weight, and high media consumption. In addition, high intakes of meat and sausages, total beverages, water and tea, total food and beverages, as well as energy-providing food and beverages were significantly associated with overweight as well as with obesity. Long sleep time was negatively associated with obesity among 3- to 10-year olds. Determinants of obesity occurred more often among children and adolescents with low SES. Conclusion: Parental overweight and a low SES are major potential determinants of obesity. Families with these characteristics should be focused on in obesity prevention. [ABSTRACT FROM AUTHOR]

Background: Studies on health inequalities still focus mostly on adults. Research about social disparities and health in children is slowly increasing, also in Germany, but these studies are mostly restricted to individual social variables derived from the parents to determine social class. This paper analyses the data of the medical check-up prior to school enrolment to determine differences concerning overweight, participation in health check-ups and immunization; it includes individual social variables but also regional variables describing the social environment of the children. Methods: The dataset includes 9,353 children who started school in 2004 in Munich, Germany. Three dependent variables are included (i.e. overweight, health check-ups, vaccinations). The individual level social variables are: children's sex, mother tongue of the parents, Kindergarten visit. On the small scale school district level, two regional social variables could be included as well, i.e. percentage of single-parent households, percentage of households with low educational level. Associations are assessed by cross tables and regression analyses. The regional level variables are included by multilevel analyses. Results: The analyses indicate that there is a large variation between the school districts concerning the three dependent variables, and that there is no district with very 'problematic values' for all three of them (i.e. high percentage of overweight, low levels of health check-ups and vaccinations). Throughout the bivariate and multivariate analyses, the mother tongue of the children's parents shows the most pronounced association with these dependent variables; i.e. children growing up in non-German-speaking families tend to be more overweight and don't visit preventive check-ups as often as children of German-speaking parents. An opposite association can be seen concerning vaccinations. Regional level influences are present as well, but they are rather small when the individual level social variables are controlled for. Conclusion: The dataset of the medical check-up prior to school enrolment offers a great opportunity for public health research, as it comprises a whole age cohort. The number and scope of variables is quite limited, though. On one hand, it includes only few variables on health or health related risks. On the other, it would be important to have more information from the region where the children live, e.g. the availability of community and health care services for parents and children, social networks of families with children, areas where children can play outside, traffic noise and air pollution. Despite these shortcomings, the need for specific interventions can already be derived from the data analyzed here, e.g. programs to reduce overweight in children should focus on parents with a mother tongue other than German. [ABSTRACT FROM AUTHOR]

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]

Background: Young people below the age of 18, whose lives are affected by looking after a relative with a disability or long-term illness, are called young carers. Evidence based family oriented support for young carers and their families in Germany is currently being developed. To allow for scientific evaluation, an outcome criterion needs to be chosen. Until today, there are no assessment instruments available, which focus on young carer's specific demands and needs. As HRQOL seems to be an adequate alternative outcome criterion, an integrative review of the literature was carried out to verify this assumption. Methods: The aim of the integrative review was to get information about a) the concept and the common definition of HRQOL in children, b) preferable HRQOL assessment techniques in children, and c) the relevance of HRQOL measures for the population of young carers. An additional aim of the review was to give advice on which instrument fits best to assess young carer's HRQOL in Germany. Searches were conducted in PubMed in order to obtain papers reporting about a) the development or psychometric assessment of instruments measuring HRQOL in children and adolescents up to the age of 18, and b) on the conceptual framework of HRQOL in children. Results: HRQOL is a multidimensional construct covering physical, emotional, mental, social, and behavioural components of well-being and functioning as subjective perceived by a person depending on the cultural context and value system one is living in. Young carer's problems and needs are well covered by these common domains of HRQOL. Since no specific HRQOL-measures are available to address young carers, a generic one has to be chosen which a) has been created for use in children, b) allows self- and proxy-report, and c) has good psychometric testing results. Comparing four generic measures with currently best published psychometric testing results, items of the KIDSCREEN cover young carer's specific problems most accurate. Conclusion: The KIDSCREEN questionnaires seems adequate to evaluate the intervention as their items cover young carer's needs and problems most accurate. [ABSTRACT FROM AUTHOR]

Background: Attempts to reduce high utilisation of psychiatric inpatient care by targeting the critical time of hospital discharge have been rare. Methods: This paper presents design and methods of the study "Effectiveness and Cost-Effectiveness of Needs-Oriented Discharge Planning and Monitoring for High Utilisers of Psychiatric Services" (NODPAM), a multicentre RCT conducted in five psychiatric hospitals in Germany. Inclusion criteria are receipt of inpatient psychiatric care, adult age, diagnosis of schizophrenia or affective disorder, defined high utilisation of psychiatric care during two years prior to the current admission, and given informed consent. Consecutive recruitment started in April 2006. Since then, during a period of 18 months, comprehensive outcome data of 490 participants is being collected at baseline and during three follow-up measurement points. The manualised intervention applies principles of needs-led care and focuses on the inpatient-outpatient transition. A trained intervention worker provides two intervention sessions: (a) Discharge planning: Just before discharge with the patient and responsible clinician at the inpatient service; (b) Monitoring: Three months after discharge with the patient and outpatient clinician. A written treatment plan is signed by all participants after each session. Primary endpoints are whether participants in the intervention group will show fewer hospital days and readmissions to hospital. Secondary endpoints are better compliance with aftercare, better clinical outcome and quality of life, as well as cost-effectiveness and cost-utility. Discussion: If a needs-oriented discharge planning and monitoring proves to be successful in this RCT, a tool will be at hand to improve patient outcome and reduce costs via harmonising fragmented mental health service provision. Trial Registration: ISRCTN59603527 [ABSTRACT FROM AUTHOR]

Background: There has been a marked increase in the use of complementary and alternative medicine (CAM) in recent years worldwide. In Germany, apart from 'Heilpraktiker' (= state-licensed, non-medical CAM practitioners), some general practitioners (GPs) provide CAM in their practices. This paper aims to explore the attitudes of GPs about the role of CAM in Germany, in relation to the healthcare system, quality of care, medical education and research. Furthermore, experiences of GPs integrating CAM in their daily practice were explored. Methods: Using a qualitative methodological approach 3 focus groups with a convenience sample of 17 GPs were conducted. The discussions were transcribed verbatim and analysed using qualitative content analysis. Results: The majority of the participating GPs had integrated one or more CAM therapies into their every-day practice. Four key themes were identified based on the topics covered in the focus groups: the role of CAM within the German healthcare system, quality of care, education and research. Within the theme 'role of CAM within the healthcare system' there were five categories: integration of CAM, CAM in the Statutory Health Insurance, modernisation of the Statutory Health Insurance Act, individual healthcare services and 'Heilpraktiker'. Regarding quality of care there were two broad groups of GPs: those who thought patients would benefit from standardizing CAM and those who feared that quality control would interfere with the individual approach of CAM. The main issues identified relating to research and education were the need for the development of alternative research strategies and the low quality of existing CAM education respectively. Conclusion: The majority of the participating GPs considered CAM as a reasonable complementary approach within primary care. The study increased our understanding of GPs attitudes about the role of CAM within the German healthcare system and the use of 'Heilpraktiker' as a competing CAM-provider. It seems to be a need for increased funding for research, better education and remuneration by the Statutory Health Insurance in order to improve access to 'Integrative medicine' in Germany. [ABSTRACT FROM AUTHOR]

Background: The planned nationwide implementation of mammography screening 2007 in Germany will increase the occurrence of mammographically detected breast abnormalities. These abnormalities are normally evaluated by minimal invasive core biopsy. To minimize false positive and false negative histological findings, quality assurance of the pathological evaluation of the biopsies is essential. Various guidelines for quality assurance in breast cancer diagnosis recommend applying the B-classification for histopathological categorization. However, to date there are only few studies that reported results about reliability and validity of B-classification. Therefore, objectives of our study are to determine the inter- and intraobserver variability (reliability study) and construct and predictive validity (validity study) of core biopsy evaluation of breast abnormalities. This paper describes the design and objectives of the DIOS Study. Methods/Design: All consecutive asymptomatic and symptomatic women with breast imaging abnormalities who are referred to the University Hospital of Halle for core breast biopsy over a period of 24 months are eligible. According to the sample size calculation we need 800 women for the study. All patients in the study population underwent clinical and radiological examination. Core biopsy is performed by stereotactic-, ultrasound- or magnetic resonance (MR) guided automated gun method or vacuum assisted method. The histopathologic agreement (intra- and interobserver) of pathologists and the histopathologic validity will be evaluated. Two reference standards are implemented, a reference pathologist and in case of suspicious or malignant findings the histopathologic result of excision biopsy. Furthermore, a self administrated questionnaire which contains questions about potential risk factors of breast cancer, is sent to the participants approximately two weeks after core biopsy. This enables us to run a case-control-analysis (woman with breast cancer histological verified after excision are defined as cases, woman without malignant breast lesions are defined as controls) to investigate the predictive values of various risk factors on breast cancer risk. Conclusion: The analysis of reliability and validity of the histopathological evaluation of core biopsy specimens of breast abnormalities is intended to provide important information needed for a high quality in breast cancer diagnostic and for planning of treatment strategies. [ABSTRACT FROM AUTHOR]

Background: Distal radius and proximal femoral fractures are typical injuries in later life, predominantly due to simple falls, but modulated by other relevant factors such as osteoporosis. Fracture incidence rates rise with age. Because of the growing proportion of elderly people in Western industrialized societies, the number of these fractures can be expected to increase further in the coming years, and with it the burden on healthcare resources. Our study therefore assessed the effects of these injuries on the health status of older people over time. The purpose of this paper is to describe the study method, clinical parameters of fracture patients during hospitalization, mortality up to one and a half years after discharge in relation to various factors such as type of fracture, and to describe changes in mobility and living situation. Methods: Data were collected from all consecutive patients (no age limit) admitted to 423 hospitals throughout Germany with distal radius or femoral fractures (57% acute-care, femoral and forearm fractures; 43% rehabilitation, femoral fractures only) between January 2002 and September 2003. Polytrauma and coma patients were excluded. Demographic characteristics, exact fracture location, mobility and living situation, clinical and laboratory parameters were examined. Current health status was assessed in telephone interviews conducted on average 6-7 months after discharge. Where telephone contact could not be established, at least survival status (living/deceased/date of death) was determined. Results: The study population consisted of 12,520 femoral fracture patients (86.8% hip fractures), average age 77.5 years, 76.5% female, and 2,031 forearm fracture patients, average age 67.6 years, 81.6% female. Women's average age was 6.6 (femoral fracture) to 10 years (forearm fracture) older than men's (p < 0.0001). Only 4.6% of femoral fracture patients experienced changes in their living situation post-discharge (53% because of the fracture event), although less than half of subjects who were able to walk without assistive devices prior to the fracture event (76.7%) could still do so at time of interview (34.9%). At time of interview, 1.5% of subjects were bed-ridden (0.2% before fracture). Forearm fracture patients reported no change in living situation at all. Of the femoral fracture patients 119 (0.95%), and of the forearm fracture patients 3 (0.15%) died during hospital stay. Post-discharge (follow-up one and a half years) 1,463 femoral fracture patients died (19.2% acute-care patients, 8.5% rehabilitation patients), but only 60 forearm fracture patients (3.0%). Ninety percent of femoral fracture deaths happened within the first year, approximately 66% within the first 6 months. More acute-care patients with a pertrochanteric fracture died within one year post-discharge (20.6%) than patients with a cervical fracture (16.1%). Conclusion: Mortality after proximal femoral fracture is still alarmingly high and highest after pertrochanteric fracture. Although at time of interview more than half of femoral fracture patients reported reduced mobility, most patients (96%) attempt to live at home. Since forearm fracture patients were on average 10 years younger than femoral fracture patients, forearm fractures may be a means of diagnosing an increased risk of later hip fractures. [ABSTRACT FROM AUTHOR]

Background: The provision and quality of end-of-life care (EoLC) in Germany is inconsistent. Therefore, an evaluation of current EoLC based on quality indicators is needed. This study aims to evaluate EoLC in Germany on the basis of quality indicators pertaining to curative overtreatment, palliative undertreatment and delayed palliative care (PC). Results were compared with previous findings., Methods: Data from a statutory health insurance provider (AOK Lower Saxony) pertaining to deceased members in the years 2016 and 2017 were used to evaluate EoLC. The main indicators were: chemotherapy for cancer patients in the last month of life, first-time percutaneous endoscopic gastrostomy (PEG) for patients with dementia in the last 3 months of life, number of hospitalisations and days spent in inpatient treatment in the last 6 months of life, and provision of generalist and specialist outpatient PC in the last year of life. Data were analysed descriptively., Results: Data for 64,275 deceased members (54.3% female; 35.1% cancer patients) were analysed. With respect to curative overtreatment, 10.4% of the deceased with cancer underwent chemotherapy in the last month and 0.9% with dementia had a new PEG insertion in the last 3 months of life. The mean number of hospitalisations and inpatient treatment days per deceased member was 1.6 and 16.5, respectively, in the last 6 months of life. Concerning palliative undertreatment, generalist outpatient PC was provided for 28.0% and specialist outpatient PC was provided for 9.0% of the deceased. Regarding indicators for delayed PC, the median onset of generalist and specialist outpatient PC was 47.0 and 24.0 days before death, respectively., Conclusion: Compared to data from 2010 to 2014, the data analysed in the present study suggest an ongoing curative overtreatment in terms of chemotherapy and hospitalisation, a reduction in new PEG insertions and an increase in specialist PC. The number of patients receiving generalist PC remained low, with delayed onset. Greater awareness of generalist PC and the early integration of PC are recommended., Trial Registration: The study was registered in the German Clinical Trials Register ( DRKS00015108 ; 22 January 2019).

Background: Functional impairment affects many patients with schizophrenia. Treatment with the long-acting injectable antipsychotic aripiprazole once-monthly (AOM) may help improve functioning. Objectives: To explore changes in functioning in patients with schizophrenia who received AOM treatment in observational studies. Methods: Here we report functional outcomes in the form of Global Assessment of Functioning (GAF) scores in a pooled analysis of data from two observational studies from Canada (NCT02131415) and Germany (vfa non-interventional studies registry 15960N). Data from 396 patients were analyzed. Results: At baseline, the mean GAF score was 47.7 (SD 13.4). During 6 months of treatment with AOM, the mean GAF score increased to 59.4 (SD 15.8). Subgroups stratified by patient age (≤35 years/>35 years), sex, disease duration (≤5 years/>5 years) and disease severity at baseline had all significantly improved their GAF at month 6. 51.5% of the patients showed a GAF score increase of at least 10 points, which was regarded as clinically meaningful, and were considered responders. Conclusions: These data show that treatment with AOM may help improve patient functioning in a routine treatment setting. Trial registration: NCT02131415 (May 6, 2014), vfa non-interventional studies registry 15960N. [ABSTRACT FROM AUTHOR]

Background: The Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) is a 14-item scale for assessing agitation and aggression, derived from the original 29-item CMAI, and completed by a proxy. Because the CMAI-SF has not yet been validated in German language, the aim of this study is to explore its construct validity. Methods: Baseline data from a cluster-randomized trial to evaluate a non-pharmacological complex intervention for people living with dementia (PlwD) and mild cognitive impairment (MCI) were analyzed. The study sample consisted of 97 shared-housing arrangements (SHAs) in Germany, comprising N = 341 residents with mild to severe dementia and MCI. Trained nursing staff collected data by proxy-rating the CMAI-SF, Neuropsychiatric Inventory-Nursing Home Version (NPI-NH), and QUALIDEM. They also conducted the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). Results: In an exploratory factor analysis, three factors emerged: "aggressive behavior", "verbally agitated behavior", and "physically non-aggressive behavior". The CMAI-SF total score showed good internal consistency (α =.85), and the factors themselves showed adequate internal consistency (α =.75/.76/.73). The CMAI-SF showed convergent validity with the NPI-NH agitation item (r =.66) and the NPI-NH "agitation & restless behavior" factor (r =.82). Discriminant validity was confirmed by a low (r =.28) correlation with the NPI-NH apathy item. Quality of life decreased significantly with agitation, as the CMAI-SF showed a moderate negative correlation with the QUALIDEM total score (r = -.35). Conclusions: The 14-item CMAI-SF is a time-efficient, reliable, and valid assessment instrument. Three factors emerged that were similar to those already found in nursing home samples for the original CMAI and the CMAI-SF and in day care samples for the CMAI-SF. The findings provide preliminary evidence that the CMAI-SF can be used instead of the CMAI to reduce time, costs, and burden in future trials. Trial registration: The DemWG study from which data were used to draft this manuscript was prospectively registered on 16 July 2019 at ISRCTN registry (ISRCTN89825211). [ABSTRACT FROM AUTHOR]

Background: Mental disorders (MDs) are one of the leading causes for workforce sickness absence and disability worldwide. The burden, costs and challenges are enormous for the individuals concerned, employers and society at large. Although most MDs are characterised by a high risk of relapse after treatment or by chronic courses, interventions that link medical-psychotherapeutic approaches with work-directed components to facilitate a sustainable return to work (RTW) are rare. This protocol describes the design of a study to evaluate the (cost-)effectiveness and implementation process of a multimodal, clinical and work-directed intervention, called RTW-PIA, aimed at employees with MDs to achieve sustainable RTW in Germany. Methods: The study consists of an effectiveness, a health-economic and a process evaluation, designed as a two-armed, multicentre, randomised controlled trial, conducted in German psychiatric outpatient clinics. Sick-listed employees with MDs will receive either the 18-month RTW-PIA treatment in conjunction with care as usual, or care as usual only. RTW-PIA consists of a face-to-face individual RTW support, RTW aftercare group meetings, and web-based aftercare. Assessments will be conducted at baseline and 6, 12, 18 and 24 months after completion of baseline survey. The primary outcome is the employees´ achievement of sustainable RTW, defined as reporting less than six weeks of working days missed out due to sickness absence within 12 months after first RTW. Secondary outcomes include health-related quality of life, mental functioning, RTW self-efficacy, overall job satisfaction, severity of mental illness and work ability. The health-economic evaluation will be conducted from a societal and public health care perspective, as well as from the employer's perspective in a cost–benefit analysis. The design will be supplemented by a qualitative effect evaluation using pre- and post-interviews, and a multimethod process evaluation examining various predefined key process indicators from different stakeholder perspectives. Discussion: By applying a comprehensive, multimethodological evaluation design, this study captures various facets of RTW-PIA. In case of promising results for sustainable RTW, RTW-PIA may be integrated into standard care within German psychiatric outpatient clinics. Trial registration: The study was prospectively registered with the German Clinical Trials Register (DRKS00026232, 1 September 2021). [ABSTRACT FROM AUTHOR]

Background: In Germany, oral emergency contraception (EC) with the active ingredients levonorgestrel (LNG) and ulipristal acetate (UPA) is available as over-the-counter (OTC) medicine only from community pharmacies (CPs). Because of the window of effect, which is limited to only a few days, CPs have a great responsibility to provide rapid and unimpeded access, while also ensuring "adequate" counseling. The aim was—for the first time in Europe and thus also in Germany for the methodology used in this study—to investigate immediate availability, pricing, and aspects of counseling. Methods: Covert mystery calls were conducted in a random sample of CPs stratified by districts in the German capital Berlin. Each of the 263 CPs included was called once at random by one of two trained female student mystery callers. They simulated a product-based scenario for the UPA original ellaOne®, citing a contraceptive failure one day ago as the reason. Results: Of 257 successfully called CPs, UPA preparations were immediately available in 98.4% (253/257) and LNG preparations in 86.8% (184/212) of CPs. Prices for UPA preparations varied from €15.95 to €42.95 (∆ 169%; median €35.00 [interquartile range (IQR) €5.91]) and for LNG preparations from €10.60 to €32.49 (Δ 207%; median €22.00 [IQR €5.76]). Information about the correct different window of effect of UPA and LNG preparations was provided in 69.8% (127/182) of CPs. UPA preparations were recommended in 63.1% (111/176) and LNG preparations in 17.2% (30/174) of CPs. Information was provided on how to take them as soon as possible in 30.8% (44/143) of CPs and on how to use them after vomiting in 46.0% (64/139). Conclusions: Berlin CPs support access through high immediate availability, especially to UPA preparations. However, access is hampered by high absolute price ranges of both UPA and LNG preparations, which could ideally be minimized by a comparison app. It is positive that CPs promote the benefits of UPA preparations by recommending them noticeably more often than LNG preparations. However, there are deficiencies in giving advice, so there is a need to raise awareness among pharmacy staff to ensure "adequate" counseling in advance over the phone. [ABSTRACT FROM AUTHOR]

Background: Stroke is a major cause of death and the most frequent cause of permanent disability in western countries. Repetitive transcranial brain stimulation (rTMS) has been used to enhance neuronal plasticity after stroke, yet with only moderate effect sizes. Here we will apply a highly innovative technology that synchronizes rTMS to specific brain states identified by real-time analysis of electroencephalography. Methods: One hundred forty-four patients with early subacute ischemic motor stroke will be included in a multicenter 3-arm parallel, randomized, double-blind, standard rTMS and sham rTMS-controlled exploratory trial in Germany. In the experimental condition, rTMS will be synchronized to the trough of the sensorimotor µ-oscillation, a high-excitability state, over ipsilesional motor cortex. In the standard rTMS control condition the identical protocol will be applied, but non-synchronized to the ongoing µ-oscillation. In the sham condition, the same µ-oscillation-synchronized protocol as in experimental condition will be applied, but with ineffective rTMS, using the sham side of an active/placebo TMS coil. The treatment will be performed over five consecutive work days (1,200 pulses per day, 6,000 pulses total). The primary endpoint will be motor performance after the last treatment session as measured by the Fugl-Meyer Assessment Upper Extremity. Discussion: This study investigates, for the first time, the therapeutic efficacy of personalized, brain-state-dependent rTMS. We hypothesize that synchronization of rTMS with a high-excitability state will lead to significantly stronger improvement of paretic upper extremity motor function than standard or sham rTMS. Positive results may catalyze a paradigm-shift towards personalized brain-state-dependent stimulation therapies. Trial registration: This study was registered at ClinicalTrials.gov (NCT05600374) on 10–21-2022. [ABSTRACT FROM AUTHOR]

Background: CBT has been found effective for the treatment of EDs and obesity. However not all patients achieve clinically significant weight loss and weight regain is common. In this context, technology-based interventions can be used to enhance traditional CBT but are not yet widespread. This survey therefore explores the status quo of pathways of communication between patients and therapists, the use of digital applications for therapy as well as attitudes towards VR from the perspective of patients with obesity in Germany. Methods: This cross-sectional online survey was conducted in October 2020. Participants were recruited digitally through social media, obesity associations and self-help groups. The standardized questionnaire included items concerning current treatment, paths of communication with their therapists, and attitudes toward VR. The descriptive analyses were performed with Stata. Results: The 152 participants were mostly female (90%), had a mean age of 46.5 years (SD = 9.2) and an average BMI of 43.0 kg/m² (SD = 8.4). Face-to-face communication with their therapist was considered of high importance in current treatment (M = 4.30; SD = 0.86) and messenger apps were the most frequently used digital application for communication. Participants were mostly neutral regarding the inclusion of VR methods in obesity treatment (M = 3.27; SD = 1.19). Only one participant had already used VR glasses as part of treatment. Participants considered VR suitable for exercises promoting body image change (M = 3.40; SD = 1.02). Discussion: Technological approaches in obesity therapy are not widespread. Face-to-face communication remains the most important setting for treatment. Participants had low familiarity with VR but a neutral to positive attitude toward the technology. Further studies are needed to provide a clearer picture of potential treatment barriers or educational needs and to facilitate the transfer of developed VR systems into clinical practice. Plain english summary: CBT is the treatment of choice for a variety of psychological disorders, among them eating disorders and obesity. However not all patients benefit equally and weight-regain is frequent. Technology-based approaches like virtual reality can enhance traditional CBT, but they are not yet used very often in clinical practice. This study asked patients with obesity which digital methods of communication and treatment were part of their obesity therapy and whether they would welcome VR approaches in their therapy. 152 patients participated and reported a face-to-face communication with their therapist to be of high importance. Messenger apps (e.g. WhatsApp) were the most commonly used digital methods of communication. VR applications or wearables do not play a role in the respondents' therapy. Participants were mostly neutral toward VR technology but expressed positive expectations toward VR as part of body image therapy. [ABSTRACT FROM AUTHOR]

Background: The prognosis of patients with advanced biliary tract cancer (BTC) who have progressed on gemcitabine plus cisplatin is dismal. Trifluridine/tipiracil (FTD/TPI) and irinotecan have proven efficacy in different gastrointestinal malignancies. We therefore hypothesized that this combination might improve the therapeutic outcome in patients with BTC after failure of first line treatment. Methods: TRITICC is an interventional, prospective, open-label, non-randomised, exploratory, multicentre, single-arm phase IIA clinical trial done in 6 sites with expertise in managing biliary tract cancer across Germany. A total of 28 adult patients (aged ≥ 18 years) with histologically verified locally advanced or metastatic biliary tract cancer (including cholangiocarcinoma and gallbladder or ampullary carcinoma) with documented radiological disease progression to first-line gemcitabine based chemotherapy will be included to receive a combination of FTD/TPI plus irinotecan according to previously published protocols. Study treatment will be continued until disease progression according to RECIST 1.1 criteria or occurrence of unacceptable toxicity. The effect of FTD/TPI plus irinotecan on progression-free survival will be analyzed as primary endpoint. Safety (according to NCI-CTCAE), response rates and overall survival are secondary endpoints. In addition, a comprehensive translational research program is part of the study and might provide findings about predictive markers with regard to response, survival periods and resistance to treatment. Discussion: The aim of TRITICC is to evaluate the safety and efficacy of FTD/TPI plus irinotecan in patients with biliary tract cancer refractory to previous Gemcitabine based treatment. Trial registration: EudraCT 2018–002936-26; NCT04059562 [ABSTRACT FROM AUTHOR]

Background: Surveillance of surgical site infections (SSI) relies on access to data from various sources. Insights into the practices of German hospitals conducting SSI surveillance and their information technology (IT) infrastructures are scarce. The aim of this study was to evaluate current SSI surveillance practices in German hospitals with a focus on employed IT infrastructures. Methods: German surgical departments actively participating in the national SSI surveillance module "OP-KISS" were invited in August 2020 to participate in a questionnaire-based online survey. Depending on whether departments entered all data manually or used an existing feature to import denominator data into the national surveillance database, departments were separated into different groups. Selected survey questions differed between groups. Results: Of 1,346 invited departments, 821 participated in the survey (response rate: 61%). Local IT deficits (n = 236), incompatibility of import specifications and hospital information system (n = 153) and lack of technical expertise (n = 145) were cited as the most frequent reasons for not using the denominator data import feature. Conversely, reduction of workload (n = 160) was named as the main motivation to import data. Questions on data availability and accessibility in the electronic hospital information system (HIS) and options to export data from the HIS for the purpose of surveillance, yielded diverse results. Departments utilizing the import feature tended to be from larger hospitals with a higher level of care. Conclusions: The degree to which digital solutions were employed for SSI surveillance differed considerably between surgical departments in Germany. Improving availability and accessibility of information in HIS and meeting interoperability standards will be prerequisites for increasing the amount of data exported directly from HIS to national databases and laying the foundation for automated SSI surveillance on a broad scale. [ABSTRACT FROM AUTHOR]

Background: Depression, generalized and cardiac anxiety, and posttraumatic stress disorder negatively affect disease severity, participation, and mortality in patients with cardiovascular disease. Psychological treatments within cardiac rehabilitation may improve the outcomes of these patients. We therefore developed a cognitive-behavioral rehabilitation program for patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion. In Germany, similar programs are well established in musculoskeletal rehabilitation and cancer rehabilitation. However, no randomized controlled trials have evaluated if such programs achieve better outcomes in patients with cardiovascular disease compared with standard cardiac rehabilitation. Methods: Our randomized controlled trial compares cognitive-behavioral cardiac rehabilitation with standard cardiac rehabilitation. The cognitive-behavioral program complements standard cardiac rehabilitation with additional psychological and exercise interventions. Both rehabilitation programs last for four weeks. We enroll 410 patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion aged 18 to 65 years. Half of the individuals are randomly assigned to cognitive-behavioral rehabilitation and the other half to standard cardiac rehabilitation. Our primary outcome is cardiac anxiety 12 months after the end of rehabilitation. Cardiac anxiety is assessed with the German 17-item version of the Cardiac Anxiety Questionnaire. Secondary outcomes cover outcomes assessed by clinical examinations and medical assessments and a range of patient-reported outcome measures. Discussion: This randomized controlled trial is designed to determine the effectiveness of cognitive-behavioral rehabilitation at decreasing cardiac anxiety in patients with cardiovascular disease and mild or moderate mental illness or stress or exhaustion. Trial registration: German Clinical Trials Register (DRKS00029295, June 21, 2022). [ABSTRACT FROM AUTHOR]

Background: Multimorbidity is a common phenomenon among patients treated in general practices. Key challenges within this group include functional difficulties, polypharmacy, treatment burden, fragmentation of care, reduced quality of life and increased health care utilization. These problems cannot be solved in the short consultation time of a general practitioner (GP) since there is an increasing shortage of GPs. In many countries, advanced practice nurses (APNs) are successfully integrated into primary health care for multimorbid patients. The objective of this study is to examine whether the integration of APNs in the primary care of multimorbid patients in Germany leads to optimized care of the target group and to a reduction in the workload of the GPs. Methods: The intervention includes the integration of APNs into the care for multimorbid patients in general practice for twelve months. Qualifications for APNs include a master's level academic degree and 500 hours of project-specific training. Their tasks include in-depth assessment, preparation, implementation, monitoring and evaluation of a person-centred and evidence-based care plan. In this nonrandomized controlled trial, a prospective multicentre mixed methods study will be performed. The main inclusion criterion was the cooccurrence of three chronic diseases. For data collection in the intervention group (n = 817), routine data from health insurance companies and association of statutory health insurance physicians (ASHIP) will be used, as well as qualitative interviews. In addition, the intervention will be assessed through documentation of the care process and standardized questionnaires using a longitudinal design. The control group (n = 1634) will receive standard care. For the evaluation, routine data from health insurance companies are matched at a ratio of 1:2. Outcomes will be measured using emergency contacts and GP visits, treatment costs, health status of the patients and the satisfaction of parties involved. The statistical analyses will include Poisson regression to compare outcomes between the intervention and control groups. Descriptive and analytical statistical methods will be used in the longitudinal analysis of the intervention group data. Cost analysis will compare total costs and subgroup costs between the intervention and control groups. Qualitative data will be analysed using content analysis. Discussion: Challenges to this protocol could include the political and strategic environment as well as the planned number of participants. Trial registration: DRKS00026172 on DRKS. [ABSTRACT FROM AUTHOR]

Background: Mental healthcare users and patients were described as a particularly vulnerable group in the debate on the burdens of the COVID-19 pandemic. Just what this means and what normative conclusions can be derived from it depend to a large extent on the underlying concept of vulnerability. While a traditional understanding locates vulnerability in the characteristics of social groups, a situational and dynamic approach considers how social structures produce vulnerable social positions. The situation of users and patients in different psychosocial settings during the COVID-19 pandemic has not yet been comprehensively considered and ethically analyzed under the aspect of situational vulnerability. Methods: We present the results of a retrospective qualitative analysis of a survey of ethical challenges in different mental healthcare facilities of a large regional mental healthcare provider in Germany. We evaluate them ethically using a dynamic and situational understanding of vulnerability. Results: Difficulties in implementing infection prevention measures, restrictions of mental health services in favor of infection prevention, social isolation, negative health effects on mental healthcare users and patients, and challenges in implementing regulations on state and provider levels within the local specificities emerged across different mental healthcare settings as ethically salient topics. Conclusions: Applying a situational and dynamic understanding of vulnerability allows the identification of specific factors and conditions that have contributed to an increased context-dependent vulnerability for mental healthcare users and patients. These factors and conditions should be considered on the level of state and local regulations to reduce and address vulnerability. [ABSTRACT FROM AUTHOR]

Background: The huge increase of refugees to Germany caused a great challenge to the health system. We aimed to examine the level of patient-centredness in medical consultations with refugee patients, aided by video interpreters in primary care walk-in clinics (PCWC) in Hamburg. Methods: Videotaped consultations (N = 92) of 83 patients from 2017 to 2018 were analysed. Two raters used the Measure of Patient-Centered Communication (MPCC) and the International Classification of primary care (ICPC-2). MPCC scores with regard to patients' reason for seeking medical care and the procedures taken were explored using variance analyses adjusted for age, gender, and the duration of the consultation. The duration was further explored by Pearson correlations. Results: Patient-centredness of all consultations on average was 64% (95% CI 60–67) according to MPCC, with health-related issues affecting the results. The highest level of patient-centredness was achieved in psychological health issues with 79% (65–94), the lowest in respiratory ones with 55% (49–61). Longer consultations resulted in higher MPCC scores. Conclusions: The level of patient-centredness varied in the addressed health issues as well as in the duration of the consultation. Despite the variation, video interpreting in consultations supports a solid patient-centredness. Practice implications: We recommend the use of remote video interpreting services for outpatient healthcare to support patient-centred communication and to fill the gap of underrepresentation of qualified interpreters on site, regarding a high diversity of spoken languages. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic continues to spread across the globe and is associated with significant clinical and humanitarian burden. The desire for parenthood has been described to be positively correlated with psychological well-being: An unfulfilled wish for parenthood is associated with impaired mental health, and the wish for parenthood is a predictor for the development of depressive symptoms. While higher rates of anxiety and depression have been reported in individuals with minoritized sexual identities (compared to heterosexual individuals) during the COVID-19 pandemic, the specific impact of the pandemic and its social restriction measures on this population is poorly understood. Methods: From April to July 2020, we conducted an anonymous cross-sectional survey online among N = 2463 adults living in Germany. We screened for depressive symptoms (Patient Health Questionnaire-4; PHQ-4) and assessed individuals' desire for parenthood during the pandemic, and motives for or against the desire for parenthood (Leipzig questionnaire on motives for having a child, Version 20; LKM-20), with the aim of identifying differences between individuals with minoritized sexual identities and heterosexual individuals. Results: Compared to heterosexual individuals (n = 1304), individuals with minoritized sexual identities (n = 831) indicated higher levels of depressive symptoms. In our study sample the majority of all participants (81.9%) reported no change in the desire for parenthood since the COVID-19 pandemic. Conclusion: The findings underline the unmet need for social, psychological and medical support in regard to family-planning and the desire for parenthood during a pandemic. Furthermore, future research should explore COVID-19-related psychological consequences on individuals' desire for parenthood and building a family. [ABSTRACT FROM AUTHOR]

Background: Congenital cytomegalovirus (CMV) infection is the most common congenital infection worldwide and one of the leading causes of congenital hearing loss in newborns. The aim of this study was to determine the seroprevalence rate for cytomegalovirus in pregnant women and the rate of CMV serological testing utilised during pregnancy in a rural region in Germany. Methods: Retrospective data on the prevalence of CMV IgG and IgM antibodies were obtained from 3,800 women, identified in the study group of 19,511 pregnant women from outpatient settings whose samples were collected between 1 and 2014 and 30 April 2018. In addition, the serological CMV status in regards to various billing methods was further analyzed. Results: Serological CMV tests were performed in 3,800 (19.5%) out of 19,511 pregnant women. 2,081 (54.8%) of these women were CMV seronegative. Among those, seroconversion rate of 0.37–1.42% was identified. A proportion of 2,710 (14.7%) of all 18,460 women with statutory health insurance made use of the CMV testing as an individual health service. Conclusions: The low uptake of CMV serological testing in the study population covered indicates low risk awareness among pregnant women and their healthcare professionals. Presented seronegativity rates and routine seroconversion rate, demonstrate importance to improve intervention strategy to prevent feto-maternal CMV transmission. [ABSTRACT FROM AUTHOR]

Background: The UN Convention on the Rights of Persons with Disabilities, and the reformed guardianship law in Germany, require that persons with a disability, including people with dementia in Alzheimer's disease (PwAD), are supported in making self-determined decisions. This support is achieved through communication. While content-related communication is a deficit of PwAD, relational aspects of communication are a resource. Research in supported decision-making (SDM) has investigated the effectiveness of different content-related support strategies for PwAD but has only succeeded in improving understanding, which, although one criterion of capacity to consent, is not sufficient to ensure overall capacity to consent. The aim of the 'spatial intervention study' of the DECIDE project is to examine an innovative resource-oriented SDM approach that focuses on relational aspects. We hypothesise that talking to PwAD in their familiar home setting (as opposed to a clinical setting) will reduce the complexity of the decision-making process and enhance overall capacity to consent. Methods: People with a suspected or confirmed diagnosis of dementia in Alzheimer's disease will be recruited from two memory clinics (N = 80). We will use a randomised crossover design to investigate the intervention effect of the decision-making place on capacity to consent. Besides reasoning capacity, which is part of overall capacity to consent and will be the primary outcome, various secondary outcomes (e.g., other aspects of capacity to consent, subjective task complexity, decisional conflict) and suspected moderating or mediating variables (e.g., meaning of home, demographic characteristics) will be assessed. Discussion: The results of the study will be used to develop a new SDM strategy that is based on relational resources for PwAD. If a change in location achieves the anticipated improvement in capacity to consent, future research should focus on implementing this SDM strategy in a cost-effective manner in clinical practice. Trial registration: DRKS00030799. [ABSTRACT FROM AUTHOR]

Background: This study measured sleep quality among caregivers of patients with Dravet syndrome (DS) and assessed the impacts of mental health problems and caregiver burden on sleep quality. Methods: This multicenter, cross-sectional study of patients with DS and their caregivers throughout Germany consisted of a questionnaire and a prospective 4-week diary querying disease characteristics, demographic data, living conditions, nocturnal supervision, and caregivers' work situations. Sleep quality was assessed using the Pittsburgh Sleeping Quality Index (PSQI). The Hospital Anxiety and Depression Scale (HADS) and the Burden Scale for Family Caregivers (BSFC) were used to measure anxiety, symptoms of depression, and caregiver burden. Results: Our analysis included 108 questionnaires and 82 four-week diaries. Patients with DS were 49.1% male (n = 53), with a mean age of 13.5 ± 10.0 years. Caregivers were 92.6% (n = 100) female, with a mean age of 44.7 ± 10.6 years. The overall mean PSQI score was 8.7 ± 3.5, with 76.9% of participants (n = 83) scoring 6 or higher, indicating abnormal sleep quality. The HADS for anxiety and depression had overall mean scores of 9.3 ± 4.3 and 7.9 ± 3.7, respectively; 61.8% and 50.9% of participants scored above the cutoff value of 8 for anxiety and depression, respectively. Statistical analyses revealed caregiver anxiety levels and patients' sleep disturbances as major factors influencing PSQI scores. The overall mean BSFC score of 41.7 ± 11.7 indicates a moderate burden, with 45.3% of caregivers scoring 42 or higher. Conclusions: Sleep quality is severely affected among caregivers of patients with DS, correlating with anxiety, comorbidities, and patients' sleep disturbances. A holistic therapeutic approach should be implemented for patients with DS and their caregivers, focusing on the sleep quality and mental health of caregivers. Trial registration: German Clinical Trials Register (DRKS), DRKS00016967. Registered 27 May 2019, http://www.drks.de/DRKS00016967 Key points: Sleep quality is severely affected in caregivers of patients with Dravet syndrome (DS). Anxiety level, caregiver burden, and patients' comorbidities have major impacts on caregiver sleep quality. We recommend a holistic therapy approach beyond seizures, including mental health challenges faced by caregivers of patients with DS. The holistic therapeutic approach should target caregivers' sleep disorders and any concomitant causes. [ABSTRACT FROM AUTHOR]