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Purpose: To evaluate changes in distribution of teeth and in prosthodontic tooth replacement during an 11-year period in an adult population.Materials and Methods: Information on prosthetic status was collected from 4,288 participants aged 20 to 81 years at baseline in the Study of Health in Pomerania (SHIP-0) and from 2,244 participants aged 30 to 92 years who reappeared in the 11-year follow-up (SHIP-2). The tooth distribution per arch was classified into one of the six following classes: class 0 (edentulous), class 1 (one to three remaining teeth), class 2 (extended tooth-bounded space or extreme shortened dental arch), class 3 (small anterior space), class 4 (small posterior space with one or more missing premolars), or class 5 (functional dentition).Results: Longitudinally, the most pronounced change in class was the transition from class 1 to class 0 (maxilla: 54.5%, mandible: 58.3%). The percent change from other higher classes to lower classes ranged between 10% and 40%. In the same age groups of 40 to 79 years, the number of edentate arches was cut in half, with a corresponding increase in functional dentitions. The proportion of unrestored arches decreased in all classes. Double crown-retained partial removable dental prostheses (PRDPs) showed the highest increase (a 15% to 20% increase) at the expense of acrylic PRDPs in classes 1 and 2. In small spaces, the proportion of fixed dental prostheses (FDPs) also increased by 15% to 20%. Seven participants of SHIP-0 (0.16%) and 56 participants of SHIP-2 (2.5%) had dental implants.Conclusion: Similar age groups showed improvement in oral conditions. The proportion of higher-end restorations (FDPs and double crown-retained PRDPs), including the frequency of dental implants, increased. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this multicenter single mandibular implant study was to compare the clinical outcome of an immediately loaded implant placed in the midline of an edentulous mandible with the clinical outcome when closed healing and delayed loading is chosen. Here, the patient recruitment period and the main reasons for exclusion were analyzed.Materials and Methods: Patient recruitment was performed at nine German universities. Rather conservative inclusion and exclusion criteria, including denture satisfaction, denture status, a psychologic symptom checklist, and a defined bone height in the posterior mandible, had to be fulfilled. It was initially calculated that 230 persons would have to be screened within 13 months to include 180 persons in the trial.Results: Within 13 months (December 2012 to December 2013), 201 patients were screened for possible inclusion in the trial and 148 met the inclusion criteria. Finally, after the recruitment period was extended by 2.5 months, 224 patients were screened and 169 were included. Of those screened, 55 (24.6%) did not meet the inclusion criteria and were excluded. Another 4 patients (1.8%) were excluded based on their psychologic symptom checklist score, while 5 others (2.8%) showed signs of noncompliance. A further 8 patients (4.4%) decided not to participate and withdrew their informed consent, and another 3 (1.3%) were no longer available after screening. Another 2 patients were excluded due to medical contraindications and 1 due to an insufficient mandibular denture. In 34 cases (15.2%), the residual bone height did not comply with McGarry type II or III.Conclusion: Within the limitations of this patient recruitment period, it can be concluded that residual bone height is the most important factor when considering elderly edentulous patients for implant therapy. The psychologic symptom checklist score was less important. [ABSTRACT FROM AUTHOR]

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

Aim: Interprofessional education for health care professionals should be anchored at all training and study locations across Germany. In cooperation with the Medical Faculty Mannheim, an education concept trialed there, namely a longitudinal interprofessional learning sequence, was transferred and adapted to the Medical Faculty Dresden as part of the "Operation Team" support program. Here, the structured analysis and evaluation of the knowledge transfer experience is presented from the perspective of the transferee. Fromthese findings, recommendations are derived for the planning of knowledge transfer projects. Methods: The consulting work between the two faculties was listed chronologically including knowledge transfer outcomes and was described and analyzed using the comparative categories identified in sociological systems theory and in the knowledge transfer literature. In addition, knowledge transfer outcomes were categorized according to their use and their relevance to the progress of the project was assessed. Results: The coordination teams initiated 13 consulting sessions, primarily held virtually or by telephone. From these, 36 knowledge transfer outcomes were identified, of whichmost were of high relevance for the transferee in all use categories. The knowledge transfer core themes were of a strategic (e.g. the consolidation of interprofessional teaching) and content-based/didactic-methodological nature (e.g. interprofessional session design, tutor training). Conclusion: The consulting sessions played a major role in facilitating the establishment of two interprofessional learning sequences and the piloting of the associated sessions at the Dresden site. The recommendations derived for a successful transfer could also be of help for other transfer projects. [ABSTRACT FROM AUTHOR]

Recovery from stroke aims at regaining mobility through performing activities. However, research studies on time use in rehabilitation environments consistently show low activity levels of stroke patients outside their scheduled therapies. It is not clear whether the architectural layout of clinics is related to patients' activity. This study examined the nonscheduled (voluntary) activities of stroke patients during an ordinary day in a rehabilitation clinic to investigate whether and how the built environment contributes to stroke patients' independent activities. Patient shadowing was used in seven neurological rehabilitation clinics. Ten patients were observed per clinic (n = 70), each patient for 12 consecutive hours (total 840 hours). Their paths, activities, locations and traveled distances were recorded in relation to the clinics' layouts. Patients spent around 50% of the observed time in their rooms. The frequency of nonscheduled activity was low in all participating clinics (Mdn = 21,2%, IQR 6,5%–21%) compared to the scheduled activity. The median length of the nonscheduled paths for all patients was 43,42 m (average 46,97 m), with significantly longer scheduled paths (average 89,11 m, Mdn = 77,06 m, Mann-Whitney U = 536, n1 = 762, n2 = 225, p <.001, two-tailed). Corridors and seating areas in the corridors were the most frequent destinations of patients' nonscheduled paths. The clinic with the most frequent nonscheduled activity had a distinctive spatial distribution of dining and living spaces. There is a need to change the architectural layout of rehabilitation clinics to better support patients' nonscheduled activity. [ABSTRACT FROM AUTHOR]

Aims and objectives: Pressure ulcers (PUs) are a serious health problem. They can be considered as an indicator of the quality of health care and are associated with considerable cost increases for the health care system. The prevention of PUs is a major concern in hospital care. The aim of the study was to reveal the current PU prevention‐related processes and structures with a specific focus on the Accident and Emergency (A&E) Department. Method: In late 2018/early 2019, all German hospitals were invited to participate in a nationwide cross‐sectional survey. One standardized questionnaire was assigned to a representative of each hospital. The representative was asked to state what PU‐related structures and processes are implemented in their hospital, in general and specific to the A&E department. Besides mostly descriptive analysis, PU‐related processes were analysed on PU incidence in a multivariate linear regression model. Results: Two hundred seventy‐six hospitals participated in the survey. 63.4% (n = 175) of the participating hospitals had at least one PU manager. Skin inspection was the most frequently performed procedure. Although not recommended, 1.3% (2.1%) of the facilities still use sheepskins quite often (very often). In the regression model on PU incidence, only the process 'mobilization in bed' was statistically significantly associated. Although the risk of developing a PU in the emergency department is high, more than half of the facilities had no PU guidelines. Conclusion: Even if recommended procedures (skin inspection, 30° positioning) have been used frequently, regular training could help to bring new scientific findings such as the use of local skin protection dressings into clinical practice. Prevention guidelines should be established in all areas of care even for A&E as well as when patients are transferred inside or out of the hospital, where the risk of PU development was considered low. [ABSTRACT FROM AUTHOR]

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

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

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

Background: Erenumab, the first-in-class fully human monoclonal antibody targeting the calcitonin gene-related peptide receptor, was shown to be efficacious and safe for the prophylactic treatment of migraine in adults in randomized clinical trials. Large-scale, real-world evidence in multi-centre settings is still needed to confirm these results. Erenumab patient profiles outside clinical trials and physicians' treatment patterns, as well as data from patients treated in Germany, a severely impacted population, are not published yet. Methods: TELESCOPE was a multi-centre survey gathering real-world data from 45 German headache centres between July 2019 and December 2019. The project consisted of two parts. In the first part, treating physicians shared their experiences on current erenumab treatment with regard to patient profiles, treatment patterns and treatment responses. In the second part, a retrospective chart review was conducted of 542 migraine patients treated with erenumab for at least three months. Treatment responses focused on various aspects of patients' quality of life. Results: The analysis of 542 patients' charts revealed that three-month treatment with erenumab significantly reduced monthly headaches, migraine and acute medication days. Furthermore, headache intensity and frequency were reduced in over 75 % and accompanying aura in 35 % of patients. The clinical global impression scale revealed a general improvement in 91 % of patients. According to the treating physicians' professional judgement, 83 % of patients responded to erenumab and 80 % were satisfied with the treatment. Physicians evaluated restricted quality of life, the number of monthly migraine days and previous, prophylactic treatments as the main components of the current patient profile for monoclonal antibody recipients. Based on the assessment of physicians, erenumab reduced migraine symptoms in 65 % and increased quality of life in more than 75 % of their patients. Conclusions: TELESCOPE confirms positive treatment responses with erenumab shown in clinical trials in a real-world multi-centre setting. The results show consistently positive experiences of physicians utilizing erenumab in clinical practice and underline that therapy with this monoclonal antibody is effective in migraine patients, particular in those, who have failed several prophylactic therapies. [ABSTRACT FROM AUTHOR]

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

Background: Randomized controlled trials (RCTs), especially multicentric, with complex interventions are methodically challenging. Careful planning under everyday conditions in compliance with the relevant international quality standard (Good Clinical Practice [GCP] guideline) is crucial. Specific challenges exist for RCTs conducted in delivery rooms due to various factors that cannot be planned beforehand. Few published RCTs report challenges and problems in implementing complex interventions in maternity wards. In Germany as well as in other countries, midwives and obstetricians have frequently little experience as investigators in clinical trials.Methods: The aim is to describe the key methodological and organizational challenges in conducting a multicenter study in maternity wards and the solution strategies applied to them. In particular, project-related and process-oriented challenges for hospital staff are considered. The exemplarily presented randomized controlled trial "BE-UP" investigates the effectiveness of an alternative design of a birthing room on the rate of vaginal births and women-specific outcomes.Results: The results are presented in five sectors: 1) Selection of and support for cooperating hospitals: they are to be selected according to predefined criteria, and strategies to offer continuous support in trial implementation must be mapped out. 2) Establishing a process of requesting informed consent: a quality-assured process to inform pregnant women early on must be feasible and effective. 3) Individual digital real-time randomization: In addition to instructing maternity teams, appropriate measures for technical failure must be provided. 4) The standardized birthing room: The complex intervention is to be implemented according to the study protocol yet adapted to the prevailing conditions in the delivery rooms. 5) GCP-compliant documentation: midwives and obstetricians will be instructed in high-quality data collection, supported by external monitoring throughout the trial.Conclusion: Since not all potential challenges can be anticipated in the planning of a trial, study teams need to be flexible and react promptly to any problems that threaten recruitment or the implementation of the complex intervention. Thought should be given to the perspectives of midwives and obstetricians as recruiters and how clinic-intern processes could be adapted to correspond with the trial's requirements.Trial Registration: The BE-UP study was registered on 07/03/ 2018 in the German Register for Clinical Trials under Reference No. DRKS00012854 and can also be found on the International Clinical Trials Registry Platform (ICTRP) (see https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS0001285 ). [ABSTRACT FROM AUTHOR]

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

Introduction: The diagnosis or exclusion of obstructive stable coronary artery disease (SCAD) in clinical practice is challenging and therefore clinical guidelines provide recommendations on the use of non-invasive and invasive testing. For Germany, data obtained from the OECD and health insurances indicate a potential non-adherence to guideline-recommended diagnostic pathways. However, there is a lack of prospective and reliable evidence for appropriate use of invasive coronary angiography (CA) in Germany.Objective: To provide evidence on the nature and extent of guideline non-adherence in patients undergoing CA with presumed obstructive SCAD in Germany and, to evaluate the clinical and economic consequences of potential deviations in guideline adherence.Methods: ENLIGHT-KHK is a multicentre, prospective observational study recruiting 1500 patients being admitted for CA with presumed obstructive SCAD and exclusion of acute myocardial infarction (DRKS00015638). The primary outcome measure is the adherence to clinical guidelines in the decision-making process for use of CA. Therefore, the patients' diagnostic pathways and adherence to German and European guidelines will be assessed using clinical data, health-claims data, and a patient questionnaire. The primary safety outcome is a composite of myocardial infarction, stroke and all-cause death. Secondary outcome measures are periprocedural complications and costs. Using a decision-analytic model, the clinical and economic impact of observed guideline adherence in clinical practice will be assessed. Potential barriers and facilitators of guideline-adherent decision-making will be evaluated via semi-structured interviews.Conclusions: ENLIGHT-KHK will give insights into the appropriateness of invasive CA in Germany and enable the development of concepts to improve guideline-adherence in the German health-care setting. [ABSTRACT FROM AUTHOR]

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

OBJECTIVES: With this study, our aim was to quantify the relative risk (RR) of diabetic ketoacidosis at diagnosis of type 1 diabetes during the year 2020 and to assess whether it was associated with the regional incidence of coronavirus disease 2019 (COVID-19) cases and deaths. METHODS: Multicenter cohort study based on data from the German Diabetes Prospective Follow-up Registry. The monthly RR for ketoacidosis in 2020 was estimated from observed and expected rates in 3238 children with new-onset type 1 diabetes. Expected rates were derived from data from 2000 to 2019 by using a multivariable logistic trend regression model. The association between the regional incidence of COVID-19 and the rate of ketoacidosis was investigated by applying a log-binomial mixed-effects model to weekly data with Germany divided into 5 regions. RESULTS: The observed versus expected frequency of diabetic ketoacidosis was significantly higher from April to September and in December (mean adjusted RRs, 1.48-1.96). During the first half of 2020, each increase in the regional weekly incidence of COVID-19 by 50 cases or 1 death per 100 000 population was associated with an increase in the RR of diabetic ketoacidosis of 1.40 (95% confidence interval, 1.10-1.77; P 5 .006) and 1.23 (1.14-1.32; P < .001), respectively. This association was no longer evident during the second half of 2020. CONCLUSIONS: These findings suggest that the local severity of the pandemic rather than health policy measures appear to be the main reason for the increase in diabetic ketoacidosis and thus the delayed use of health care during the pandemic. [ABSTRACT FROM AUTHOR]

Background: Staphylococcus aureus remains a common cause of ventilator-associated pneumonia, with little change in incidence over the past 15 years. We aimed to evaluate the efficacy of suvratoxumab, a monoclonal antibody targeting the α toxin, in reducing the incidence of S aureus pneumonia in patients in the intensive care unit (ICU) who are on mechanical ventilation.Methods: We did a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial at 31 hospitals in Belgium, the Czech Republic, France, Germany, Greece, Hungary, Portugal, Spain, and Switzerland. Eligible patients were in the ICU, aged ≥18 years, were intubated and on mechanical ventilation, were positive for S aureus colonisation of the lower respiratory tract, as assessed by quantitative PCR (qPCR) analysis of endotracheal aspirate, and had not been diagnosed with new-onset pneumonia. Patients were excluded if they had confirmed or suspected acute ongoing staphylococcal disease; had received antibiotics for S aureus infection for more than 48 h within 72 h of randomisation; had a Clinical Pulmonary Infection Score of 6 or higher; had an acute physiology and chronic health evaluation II score of 25 or higher with a Glasgow coma scale (GCS) score of more than 5, or an acute physiology and chronic health evaluation II score of at least 30 with a GCS score of 5 or less; had a Sequential Organ Failure Assessment score of 9 or higher; or had active pulmonary disease that would impair the ability to diagnose pneumonia. Colonised patients were randomly assigned (1:1:1), by use of an interactive voice or web response system, to receive either a single intravenous infusion of suvratoxumab 2000 mg, suvratoxumab 5000 mg, or placebo. Randomisation was done in blocks of size four, stratified by country and by whether patients had received systemic antibiotics for S aureus infection. Patients, investigators, and study staff involved in the treatment or clinical evaluation of patients were masked to patient assignment. The primary efficacy endpoint was the incidence of S aureus pneumonia at 30 days, as determined by a masked independent endpoint adjudication committee, in all patients who received their assigned treatment (modified intention-to-treat [ITT] population). Primary safety endpoints were the incidence of treatment-emergent adverse events at 30 days, 90 days, and 190 days after treatment, and the incidence of treatment-emergent serious adverse events, adverse events of special interest, and new-onset chronic disease at 190 days after treatment. All primary safety endpoints were assessed in the modified ITT population. This trial is registered with ClinicalTrials.gov (NCT02296320) and the EudraCT database (2014-001097-34).Findings: Between Oct 10, 2014, and April 1, 2018, 767 patients were screened, of whom 213 patients with confirmed S aureus colonisation of the lower respiratory tract were randomly assigned to the suvratoxumab 2000 mg group (n=15), the suvratoxumab 5000 mg group (n=96), or the placebo group (n=102). Two patients in the placebo group did not receive treatment after randomisation because their clinical conditions changed and they no longer met the eligibility criteria for dosing. As adjudicated by the data monitoring committee at an interim analysis, the suvratoxumab 2000 mg group was discontinued on the basis of predefined pharmacokinetic criteria. At 30 days after treatment, 17 (18%) of 96 patients in the suvratoxumab 5000 mg group and 26 (26%) of 100 patients in the placebo group had developed S aureus pneumonia (relative risk reduction 31·9% [90% CI -7·5 to 56·8], p=0·17). The incidence of treatment-emergent adverse events at 30 days were similar between the suvratoxumab 5000 mg group (87 [91%]) and the placebo group (90 [90%]). The incidence of treatment-emergent serious adverse events at 30 days were also similar between the suvratoxumab 5000 mg group (36 [38%]) and the placebo group (32 [32%]). No significant difference in the incidence of treatment-emergent adverse events between the two groups at 90 days (89 [93%] in the suvratoxumab 5000 mg group vs 92 [92%] in the placebo group) and at 190 days (93 [94%] vs 93 [93%]) was observed. 40 (40%) patients in the placebo group and 50 (52%) in the suvratoxumab 5000 mg group had a serious adverse event at 190 days. In the suvratoxumab 5000 mg group, one (1%) patient reported at least one treatment-emergent serious adverse event related to treatment, two (2%) patients reported an adverse event of special interest, and two (2%) reported a new-onset chronic disease.Interpretation: In patients in the ICU receiving mechanical ventilation with qPCR-confirmed S aureus colonisation of the lower respiratory tract, the incidence of S aureus pneumonia at 30 days was not significantly lower following treatment with 5000 mg suvratoxumab than with placebo. Despite these negative results, monoclonal antibodies still represent one promising therapeutic option to reduce antibiotic consumption that require further exploration and studies.Funding: AstraZeneca, with support from the Innovative Medicines Initiative Joint Undertaking. [ABSTRACT FROM AUTHOR]

Background: Cancer studies reported mixed results on benefit finding (BF) and posttraumatic growth (PTG) prevalence and few were focused on long-term survivors.Methods: BF and PTG were assessed in a multi-regional population-based study in Germany with 6952 breast, colorectal and prostate cancer survivors, using the Benefit Finding Scale and Posttraumatic Growth Inventory. We calculated the age-adjusted prevalence, stratified by demographical and clinical characteristics.Results: Overall, 66.0% of cancer survivors indicated moderate-to-high BF, and 20.5% moderate-to-high PTG. Age-adjusted prevalence of BF and PTG differed according to cancer type (breast > colorectal > prostate) and sex (female > male). BF and PTG prevalence were higher in younger than in older respondents; the age-adjusted prevalence was higher in respondents who survived more years after diagnosis. The strength and direction of associations of age-adjusted prevalence with cancer stage, disease recurrence, and time since diagnosis varied according to cancer type and sex.Conclusions: A substantial proportion of long-term cancer survivors reported moderate-to-high BF and PTG. However, the prevalence was lower in older and male cancer survivors, and during the earlier years after cancer diagnosis. Further longitudinal studies on PTG and BF in cancer survivors are warranted to address heterogeneity in survivors' experience after cancer diagnosis. [ABSTRACT FROM AUTHOR]

Background: The accurate differentiation between T1a and T1b Barrett's-related cancer has both therapeutic and prognostic implications but is challenging even for experienced physicians. We trained an artificial intelligence (AI) system on the basis of deep artificial neural networks (deep learning) to differentiate between T1a and T1b Barrett's cancer on white-light images.Methods: Endoscopic images from three tertiary care centers in Germany were collected retrospectively. A deep learning system was trained and tested using the principles of cross validation. A total of 230 white-light endoscopic images (108 T1a and 122 T1b) were evaluated using the AI system. For comparison, the images were also classified by experts specialized in endoscopic diagnosis and treatment of Barrett's cancer.Results: The sensitivity, specificity, F1 score, and accuracy of the AI system in the differentiation between T1a and T1b cancer lesions was 0.77, 0.64, 0.74, and 0.71, respectively. There was no statistically significant difference between the performance of the AI system and that of experts, who showed sensitivity, specificity, F1, and accuracy of 0.63, 0.78, 0.67, and 0.70, respectively.Conclusion: This pilot study demonstrates the first multicenter application of an AI-based system in the prediction of submucosal invasion in endoscopic images of Barrett's cancer. AI scored equally to international experts in the field, but more work is necessary to improve the system and apply it to video sequences and real-life settings. Nevertheless, the correct prediction of submucosal invasion in Barrett's cancer remains challenging for both experts and AI. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate changes in marginal bone levels around maxillary and mandibular mini-implants stabilizing complete dentures and to explore possible risk factors associated with bone loss. Materials and Methods: All eligible patients from nine private dental practices were invited to participate. Panoramic radiographs were obtained postoperatively and at the follow-up examination. The changes in bone level were estimated with linear mixed models that included the factors sex, age, jaw, region (anterior versus posterior), smoking habits, and loading concept. Results: Of the 180 invited patients, 133 participated in the follow-up (response rate: 73.9%). Of 336 mini-implants in 54 maxillas and 402 mini-implants in 95 mandibles, 15 maxillary Implants and 11 mandibular implants were lost after insertion, and 4 mandibular implants fractured. Radiographic evaluations in 11 participants were not possible. The mean marginal bone loss at the remaining 634 mini-implants in 122 patients was 0.8 mm in the maxilla and 0.5 mm in the mandible over a mean observation time of 2.2 ± 1.0 years. This difference in univariate estimation lost significance after adjusting for the other variables. Implants in former smokers showed more bone loss than implants in participants who had never smoked. Implants that were loaded 3 to 4 months after placement (delayed loading) showed more marginal bone loss than immediately loaded implants. No statistically significant differences were found between men and women, different age groups, or anterior and posterior implants. Conclusion: Mean marginal bone loss around mini-implants used to stabilize complete dentures was insignificantly higher in the maxilla than in the mandible after a mean observation period of 2.3 years. These values are comparable with marginal bone loss around standard-diameter implants. A previous smoking habit and delayed loading after implant placement with a low insertion torque were shown to be possible risk factors for bone loss. [ABSTRACT FROM AUTHOR]

Background: Since 2016, the combination of sacubitril/valsartan, which combines an angiotensin receptor and neprilysin inhibitor (ARNI), has been recommended in the guidelines for the treatment of heart failure. The adoption of new drugs may be influenced by collaboration and exchange between physicians. We aimed to determine whether characteristics of the professional networks of prescribing physicians were associated with the prescribing of ARNI in Germany.Methods: We conducted a longitudinal analysis based on claims data in 2016-2018 in Germany. The characteristics of ambulatory care physicians' networks were determined in the analysis of the patient-sharing networks of physicians in 2017. Binary logistic regression analysis with the outcome 'prescribes ARNI in 2018' (present or absent) was carried out, using network characteristics as predictors, adjusted for specialty and sociodemographic characteristics of physicians.Results: The network analysis included 8370 physicians, who had 144,636 connections. Prescribers had more connections to other physicians compared to non-prescribers (median 31 vs. 23). Regression analysis showed that the numbers of linkages to prescribers of ARNI were positively associated with prescribing ARNI. For 6-10 connections, the average marginal effect (AME) was 0.04 (confidence interval [CI] 95% 0.01-0.06) and for > 10 links the AME 0.07 (CI 95% 0.05-0.10) compared to 0-5 connections to prescriber.Conclusion: Physicians who shared patients with many other physicians were more likely to prescribe ARNI, independent of physicians' specialty. This suggested that collaboration and exchange on the basis of patient-sharing with other physicians influenced their medication prescribing decisions. [ABSTRACT FROM AUTHOR]

Background: Many surveys have been performed over the years to assess the medical and social requirements of patients with a rare disease, but no studies have focused specifically on patients in Europe or with an inherited metabolic disease (IMD). To obtain a comprehensive overview of the social and psychological status and needs of IMD patients, especially in Europe, the European Reference Network for Hereditary Metabolic Disorders (MetabERN) has performed a dedicated survey among its metabolic patients.Results: A total of 924 patients and caregivers responded to the questionnaire. Most participants were from 25 European countries, with Spain, Italy, and Germany being the most represented; only eight participants were extra-European. The survey showed that most social assistance services, from free educational/development services for those with intellectual disability to transition from childhood to adult care and job placement support, are available for a limited number of patients or are unknown to the majority of patients or their parents/caregivers. Similarly, psychological assistance for the patient or the parent/caregiver is available for a small fraction of respondents, despite the fact that the majority considers this type of support necessary for both the patient and the caregiver. In addition, for most IMD patients local specialised or emergency medical assistance is lacking, although national clinical pathways are defined, and medical professionals of reference are readily available when needed. Lastly, while most national health services in Europe cover all or part of the expenses for medications, medical devices, food supplements, dietary integrators, physiotherapy, and speech therapy, significant gaps in the economic support for healthcare and other expenses still exist.Conclusions: Overall, our survey reveals a widespread lack of social, psychological, and economic support for IMD patients in Europe. More needs to be done to provide daily assistance to IMD patients in order to alleviate the burden on caregivers and to allow patients to become independent and productive adults. Where support is actually available locally or nationally, most IMD patients are not aware of it, so an active dissemination of this information among the metabolic community is essential. [ABSTRACT FROM AUTHOR]

Toxoplasmosis is a zoonotic infection contracted through Toxoplasma gondii-contaminated food, soil, or water. Seroprevalence in Germany is high, but estimates of disease incidence are scarce. We investigated incidences for various toxoplasmosis manifestations using anonymized healthcare claims data from Germany for 2011-2016. Patients with a toxoplasmosis diagnosis during the annual observational period were considered incident. The estimated incidence was adjusted to the general population age/sex distribution. We estimated an annual average of 8,047 toxoplasmosis patients in Germany. The average incidence of non-pregnancy-associated toxoplasmosis patients was 9.6/100,000 population. The incidence was highest in 2011, at 10.6 (95% CI 9.4-12.6)/100,000 population, and lowest in 2016, at 8.0 (95% CI 7.0-9.4)/100,000 population. The average incidence of toxoplasmosis during pregnancy was 40.3/100,000 pregnancies. We demonstrate a substantial toxoplasmosis disease burden in Germany. Public health and food safety authorities should implement toxoplasmosis-specific prevention programs. [ABSTRACT FROM AUTHOR]

Background: Emergency department visits and hospital admissions are common among nursing home residents (NHRs) and seem to be higher in Germany than in other countries. Yet, research on characteristics of transfers and involved persons in the transfer decision is scarce. Aims: The aim of this study was to analyze the characteristics of hospital transfers from nursing homes (NHs) focused on contacts to physicians, family members and legal guardians prior to a transfer. Methods: We conducted a multi-center study in 14 NHs in the regions Bremen and Lower Saxony (Northwestern Germany) between March 2018 and July 2019. Hospital transfers were documented for 12 months by nursing staff using a standardized questionnaire. Data were derived from care records and perspectives of nursing staff and were analyzed descriptively. Results: Among 802 included NHRs, n = 535 unplanned hospital transfers occurred of which 63.1% resulted in an admission. Main reasons were deterioration of health status (e.g. fever, infections, dyspnea and exsiccosis) (35.1%) and falls/accidents/injuries (33.5%). Within 48 h prior to transfer, contact to at least one general practitioner (GP)/specialist/out-of-hour-care physician was 46.2% and varied between the NHs (range: 32.3–83.3%). GPs were involved in only 34.8% of transfer decisions. Relatives and legal guardians were more often informed about transfer (62.3% and 66.8%) than involved in the decision (21.8% and 15.1%). Discussion: Contacts to physicians and involvement of the GP were low prior to unplanned transfers. The ranges between the NHs may be explained by organizational differences. Conclusion: Improvements in communication between nursing staff, physicians and others are required to reduce potentially avoidable transfers. [ABSTRACT FROM AUTHOR]

Background: Obesity has been postulated to be a consequence of economic disadvantage. However, epidemiological studies failed to demonstrate a consistent link between income and body fat indicators. We examined income as a possible cause of obesity in an East German general population, focusing on appropriate representation of study variables, as well as on confounding and modification of the income-obesity association.Methods: We used data of 9599 participants in the baseline examination of the LIFE-Adult-Study, conducted in the city of Leipzig from 2011 to 2014. Body mass index (BMI) and waist circumference (WC) as obesity measures were based on standardised measurements, net equivalised income (NEI) on self-reports. We estimated adjusted means of BMI and WC within NEI categories representing the range from risk of poverty to affluence. We stratified the analyses by gender, age, and education.Results: A substantial part of the age-adjusted associations of income with obesity measures was attributable to other SES indicators. Adjusted for these variables, NEI was comparably associated with BMI and WC. Among women, BMI and WC decreased across NEI categories. The inverse associations tended to be stronger at non-working age (≥ 65 years) than at working age (< 65 years). Conversely, among working-age men, BMI and WC increased with increasing NEI. Among older men, risk of poverty was related to higher values of the obesity measures. The aforementioned associations were predominantly stronger in highly educated participants compared to those with medium/low education. The differences in mean BMI and WC between persons at risk of poverty and higher income groups were rather small, ranging from 1 to 2 kg/m2 for BMI and 2 to 4 cm for WC.Conclusions: Our investigation indicates an association between income and body fatness in an East German adult population that depends on the sociodemographic context of the people. However, it does not suggest that income disparities are a major driver of body fat accumulation in this population. Differential selection of study participants, error in the measurement of long-term income, and possibly reverse causality may have affected our conclusions. [ABSTRACT FROM AUTHOR]

Background: The impact of basic atrial rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) during AF ablation on efficacy and safety is unknown. Methods: About 3375 patients from the German Ablation Registry undergoing first‐time AF ablation were divided according to the type of AF and the basic atrial rhythm during the ablation procedure: paroxysmal AF (PAF) and SR [group Ia], PAF and AF [group Ib]), persistent AF and SR (IIa), and persistent AF and AF (IIb). Results: Patients in SR (n = 2312 [67%]) underwent cryoballoon ablation more often (Ia vs. Ib p =.002 and IIa vs. IIb p =.010, whereas in patients in AF (n = 1063 [33%]) radiofrequency (RF)‐based ablation (Ia vs. Ib p =.006 and IIa vs. IIb p =.014) including left and/or right atrial substrate modification was more frequently performed. Depending on the basic rhythm there was no difference regarding arrhythmia recurrence during long‐term follow‐up. For patients suffering from persistent AF acute procedure‐related complications were more often documented when ablated in AF (9.1% vs. 4.6%, p =.012). which was mainly driven by the higher occurrence of pericardial effusion/tamponade. For patients suffering from persistent AF, favorable results were found regarding 366‐day Kaplan–Meier estimates of the incidence of MACCE (death, myocardial infarction, and stroke; p =.011) and the composite endpoint of death, myocardial infarction, stroke, and major bleeding (p =.006), when ablated in SR. Conclusion: Basic atrial rhythm at the time of AF ablation did not affect long‐term rhythm outcome. For patients suffering from persistent AF a more favorable acute and long‐term safety profile was observed when ablated in SR. [ABSTRACT FROM AUTHOR]

Background: Occipital nerve stimulation (ONS) has shown promising results in small uncontrolled trials in patients with medically intractable chronic cluster headache (MICCH). We aimed to establish whether ONS could serve as an effective treatment for patients with MICCH.Methods: The ONS in MICCH (ICON) study is an investigator-initiated, international, multicentre, randomised, double-blind, phase 3, electrical dose-controlled clinical trial. The study took place at four hospitals in the Netherlands, one hospital in Belgium, one in Germany, and one in Hungary. After 12 weeks' baseline observation, patients with MICCH, at least four attacks per week, and history of being non-responsive to at least three standard preventive drugs, were randomly allocated (at a 1:1 ratio using a computer-generated permuted block) to 24 weeks of occipital nerve stimulation at either 100% or 30% of the individually determined range between paraesthesia threshold and near-discomfort (double-blind study phase). Because ONS causes paraesthesia, preventing masked comparison versus placebo, we compared high-intensity versus low-intensity ONS, which are hypothesised to cause similar paraesthesia, but with different efficacy. In weeks 25-48, participants received individually optimised open-label ONS. The primary outcome was the weekly mean attack frequency in weeks 21-24 compared with baseline across all patients and, if a decrease was shown, to show a group-wise difference. The trial is closed to recruitment (ClinicalTrials.gov NCT01151631).Findings: Patients were enrolled between Oct 12, 2010, and Dec 3, 2017. We enrolled 150 patients and randomly assigned 131 (87%) to treatment; 65 (50%) patients to 100% ONS and 66 (50%) to 30% ONS. One of the 66 patients assigned to 30% ONS was not implanted and was therefore excluded from the intention-to-treat analysis. Because the weekly mean attack frequencies at baseline were skewed (median 15·75; IQR 9·44 to 24·75) we used log transformation to analyse the data and medians to present the results. Median weekly mean attack frequencies in the total population decreased from baseline to 7·38 (2·50 to 18·50; p<0·0001) in weeks 21-24, a median change of -5·21 (-11·18 to -0·19; p<0·0001) attacks per week. In the 100% ONS stimulation group, mean attack frequency decreased from 17·58 (9·83 to 29·33) at baseline to 9·50 (3·00 to 21·25) at 21-24 weeks (median change from baseline -4·08, -11·92 to -0·25), and for the 30% ONS stimulation group, mean attack frequency decreased from 15·00 (9·25 to 22·33) to 6·75 (1·50 to 16·50; -6·50, -10·83 to -0·08). The difference in median weekly mean attack frequency between groups at the end of the masked phase in weeks 21-24 was -2·42 (95% CI -5·17 to 3·33). In the masked study phase, 129 adverse events occurred with 100% ONS and 95 occurred with 30% ONS. None of the adverse events was unexpected but 17 with 100% ONS and eight with 30% ONS were labelled as serious, given they required brief hospital admission for minor hardware-related issues. The most common adverse events were local pain, impaired wound healing, neck stiffness, and hardware damage.Interpretation: In patients with MICCH, both 100% ONS intensity and 30% ONS intensity substantially reduced attack frequency and were safe and well tolerated. Future research should focus on optimising stimulation protocols and disentangling the underlying mechanism of action.Funding: The Netherlands Organisation for Scientific Research, the Dutch Ministry of Health, the NutsOhra Foundation from the Dutch Health Insurance Companies, and Medtronic. [ABSTRACT FROM AUTHOR]

Objectives: To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England.Methods: A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk.Results: The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries.Conclusions: The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections. [ABSTRACT FROM AUTHOR]

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

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

Aim: This study was performed to evaluate the effects of vaginal versus intramuscular progesterone supplementations on the mood, quality of life, and metabolic changes in pregnant women with the history of previous preterm birth.Methods: This study was conducted as a prospective, randomized, open label, clinical trial evaluated 100 pregnant women who referred for prenatal visit, with 16-17 weeks of gestation from September 2014 through October 2015. The mothers were then randomly allocated into two groups: the vaginal progesterone group to receive 400 mg cyclogest vaginal suppositories (Actavis, UK limited, England) once daily, and the intramuscular progesterone group to receive weekly intramuscular injections of 250 mg of 17-hydroxyprogesterone caproate (17-HPC) (Bayer Schering Pharma, Germany), starting from the 16th to the 35th weeks of pregnancy. Demographics, medical and obstetrical history, sleeping disturbances, alteration in sexual desire, nausea/vomiting, serum levels of fasting blood sugar (FBS), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were evaluated, first and 8 weeks later.Results: About 11 (11.2%) screened positive for psychosocial disorders; 25 (25.5%) had sleep disturbance, 11 (11.2%) had alteration in sexual desire, and 29 (29.6%) had nausea/vomiting upon enrollment. After 2 months of receiving daily vaginal progesterone, there was a significant increase in the GHQ-28 score (p < .001), and rates of positive screening for psychosocial disorders (p = .001) in this group. No statistically significant differences were observed in the HDL levels (p = .06), LDL levels (p = .15), rates of impaired FBS (p = .08), nausea/vomiting (p = .2), sexual desire alteration (p = .56), and sleep disturbance (p = 1) in the participants who were randomized to this group.Conclusion: Our results indicated that psychosocial disorders increased significantly at 24th week gestational age after 2 months of progesterone consumption in both groups which could show psychological impact of progesterone regardless of the route of consumption. This calls for higher psychological attention in these women. [ABSTRACT FROM AUTHOR]

Objectives: The present study aimed to assess the current state of breast-feeding promotion in hospitals and the prevalence of breast-feeding during the first year of life in Germany and to compare the results with a study 20 years earlier.Design: In the studies on 'breast-feeding and infant nutrition in Germany' named 'SuSe', a cross-sectional survey in hospitals was combined with a subsequent prospective survey of breast-feeding and infant nutrition during the first year of life (0·5, 2, 4, 6 and 12 months after birth) in mother-infant pairs who were recruited in the hospitals. Written questionnaires and phone calls were used in SuSe I and web-based questionnaires in SuSe II. Breast-feeding promotion and prevalence were evaluated using recommendations from the WHO and the UNICEF.Setting: Two nationwide surveys SuSe I (1997-1998) and SuSe II (2017-2019).Participants: In SuSe I, 177 hospitals and 1717 mother-infant pairs and in SuSe II 109 hospitals and 962 mother-infant pairs were included.Results: In SuSe II, hospitals implemented seven of the WHO 'Ten Steps to Successful Breastfeeding' to a greater extent than the hospitals in SuSe I. More mothers exclusively breastfed for 4 months (57 % v. 33 %) and continued breast-feeding until 6 (78 % v. 48 %) and 12 months (41 % v. 13 %). In both studies, exclusive breast-feeding decreased between 4 and 6 months of age due to the introduction of complementary feeding.Conclusions: In Germany, breast-feeding habits have come closer to the recommendations over the last 20 years. [ABSTRACT FROM AUTHOR]

Background and Aims: Existing evidence suggests that text message interventions can help people to reduce their alcohol consumption. However, studies with alcohol‐dependent patients are lacking. In this study a 1‐year automatic mobile phone‐based short messaging service (SMS) intervention on alcohol consumption in patients after alcohol detoxification in hospital was compared with treatment as usual. Design Multi‐center, randomized, controlled, two parallel‐group, observer‐blinded trial. Setting and Participants: Primary and secondary care: four hospitals and community (1 million residents, 7600 km2 area in Germany). A total of 462 patients with alcohol dependence (ICD‐10) were included during inpatient detoxification treatment. Patients were randomly assigned (1 : 1) to an SMS intervention and treatment as usual (SMS + TAU; n = 230; mean age: 45.4 years; 22.6% women) or TAU alone (n = 232 mean age: 44.5 years; 22.8% women). Planned, automated messages were sent to patients over 1 year to record assistance needs. A 'yes' or missing response triggered a telephone call from a hospital therapist. Outcome was assessed by an independent survey center. Measurements: The primary end‐point was a three‐category alcohol consumption measure covering months 10–12 after discharge: abstinence, non‐heavy drinking, heavy drinking [men > 60 g/day; women > 40 g/day equal to World Health Organization (WHO) criteria: high risk and very high risk, mean consumption]. Secondary end‐points were number of abstinent days over 12 months and frequency of abstinence. Results: The arms differed primarily in the heavy drinking category (intervention group 22.2%, TAU‐only group 32.3%) in months 9–12. This is reflected by an odds ratio (OR) = 1.68, 95% confidence interval (CI) = 1.11–2.54, P = 0.015 for heavy drinking versus non‐heavy drinking/abstinence. No difference between treatments was found with respect to any drinking versus abstinence (OR = 1.13). These results were confirmed by models adjusting for randomization strata. Conclusions: In Germany, a 12‐month mobile phone short messaging service‐based intervention enhanced the reduction in heavy drinking for 1 year in routine care among adults with alcohol dependence discharged from inpatient alcohol detoxification. [ABSTRACT FROM AUTHOR]

Background: Few data are available on the long-term course and predictors of quality of life (QoL) following acute pulmonary embolism (PE).Research Question: What are the kinetics and determinants of disease-specific and generic health-related QoL 3 and 12 months following an acute PE?Study Design and Methods: The Follow-up after Acute Pulmonary Embolism (FOCUS) study prospectively followed up consecutive adult patients with objectively diagnosed PE. Patients were considered for study who completed the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire at predefined visits 3 and 12 months following PE. The course of disease-specific QoL as assessed using the PEmb-QoL and the impact of baseline characteristics using multivariable mixed effects linear regression were studied; also assessed was the course of generic QoL as evaluated by using the EuroQoL Group 5-Dimension 5-Level utility index and the EuroQoL Visual Analog Scale.Results: In 620 patients (44% women; median age, 62 years), overall disease-specific QoL improved from 3 to 12 months, with a decrease in the median PEmb-QoL score from 19.4% to 13.0% and a mean individual change of -4.3% (95% CI, -3.2 to -5.5). Female sex, cardiopulmonary disease, and higher BMI were associated with worse QoL at both 3 and 12 months. Over time, the association with BMI became weaker, whereas older age and previous VTE were associated with worsening QoL. Generic QoL also improved: the mean ± SD EuroQoL Group 5-Dimension 5-Level utility index increased from 0.85 ± 0.22 to 0.87 ± 0.20 and the visual analog scale from 72.9 ± 18.8 to 74.4 ± 19.1.Interpretation: In a large cohort of survivors of acute PE, the change of QoL was quantified between months 3 and 12 following diagnosis, and factors independently associated with lower QoL and slower recovery of QoL were identified. This information may facilitate the planning and interpretation of clinical trials assessing QoL and help guide patient management.Clinical Trial Registration: German Clinical Trials Registry (Deutsches Register Klinischer Studien: www.drks.de); No.: DRKS00005939. [ABSTRACT FROM AUTHOR]

Purpose: The Vocal Tract Discomfort Scale (VTD Scale) is a self-rating questionnaire investigating physical symptoms in the larynx associated with vocal pathology. The aim of this work was to investigate the reliability, validity, sensitivity, and specificity of the first German version and to provide normative data with thresholds for pathology and a scaling scheme. Study Design: A retrospective multicenter study was performed. Method: A total of 571 participants (409 female and 162 male), with a mean age of 47.2 years, were recruited at three German centers; of these, there were 447 participants with voice disorder and 124 vocally healthy participants. The clinical examination consisted of patient history, visual laryngeal examination, acoustic and aerodynamic assessment, perceptual analysis by the Grading-Roughness-Breathiness-Asthenia-Strain Scale, and subjective evaluation using the VTD Scale and the Voice Handicap Index (VHI). Statistics included group comparisons (t test and analysis of variance), Pearson correlation coefficient (between VTD Scale and VHI), and Cronbach’s alpha to assess validity and reliability. Analysis of receiver operating characteristics was performed to examine VTD Scale’s discriminatory ability and provide a cutoff score. Additionally, percentiles were applied to provide VTD Scale ranges. Results: There were highly significant differences between healthy participants and participants with voice disorder regarding the total score and both subscales of the VTD Scale. Internal consistency was excellent (α = .928). We found moderate, positive correlation between the VTD Scale and VHI (ρ = .596, p < .001). Receiver operating characteristics analysis showed an area under the curve of 0.876 (p < .001, 95% confidence interval [0.846, 0.906]). VTD Scale ranges were no (score: 0–13), mild (score: 14–26), moderate (score: 27–40), and severe (score: 41–96) disorder. Conclusions: Results confirm an excellent reliability and validity of the German VTD Scale. It provides additional and independent diagnostic information and is a useful instrument to complement voice assessment. The scaling into four severity subgroups allows the tool to be used for screening patients and considers a transferral to a voice specialist. [ABSTRACT FROM AUTHOR]

Background: The workplace has been identified as a priority setting for health promotion. There are potential advantages of systematically integrating Occupational Health Management (OHM) and Corporate Social Responsibility (CSR). However, OHM and CSR are usually overseen by different management branches with different sets of values, and there is a lack of empirical research regarding interfaces between OHM and CSR. Germany offers a particularly useful setting due to legislation requiring health to be promoted in the workplace. This study aims to examine key stakeholders' views and experiences regarding interfaces between OHM and CSR in German companies.Methods: Individual semi-structured qualitative interviews were conducted with a sample of 77 German stakeholders from three different groups: experts in occupational health and corporate social responsibility from various companies (n = 35), business partners (n = 19), and various non-business partners (n = 23). Transcripts were analysed using qualitative content analysis.Results: Participants identified several areas in which OHM and CSR are already interacting at strategic, structural and cultural levels, but also highlighted several barriers that undermine a more meaningful interaction. Participants reported difficulties in articulating the underlying ethical values relevant to both OHM and CSR at the strategic level. Several structural barriers were also highlighted, including a lack of resources (both financial and knowledge), and OHM and CSR departments not being fully developed or undertaken at entirely different operational levels. Finally, the missing practical implementation of corporate philosophy was identified as a critical cultural barrier to interfaces between OHM and CSR, with existing guidelines and companies' philosophies that already connect OHM and CSR not being embraced by employees and managers.Conclusions: There is already significant overlap in the focus of OHM and CSR, at the structural, strategic and cultural levels in many German companies. The potential is there, both in theory and practice, for the systematic combination of OHM and CSR. The insights from this study will be useful to ensure that closer integration between both management branches is set up in a socially sustainable and ethical manner. [ABSTRACT FROM AUTHOR]

Objective: Epidemiological studies have shown contradictory results regarding the time trend of end-stage renal disease (ESRD) in people with diabetes. This study aims to analyze the incidence of ESRD, defined as chronic renal replacement therapy (RRT), to investigate time trends among people with and without diabetes in Germany and to examine whether these patterns differ by age and sex.Research Design and Methods: The data were sourced from nationwide data pooled from two German branches of statutory health insurances covering ∼25 million inhabitants. We estimated age- and sex-standardized incidence rates (IRs) for chronic RRT among people with and without diabetes in 2010-2016 and the corresponding relative risks. Time trends were analyzed using Poisson regression.Results: We identified 73,638 people with a first chronic RRT (male 60.0%, diabetes 60.6%, mean age 71.3 years). The IR of chronic RRT among people with diabetes (114.1 per 100,000 person-years [95% CI 110.0-117.2]) was almost six times higher than among people without diabetes (19.6 [19.4-19.8]). A consistent decline in IR was observed among people with diabetes (3% annual reduction, P < 0.0001) for both sexes and all age classes. In contrast, no consistent change of IR was identified in people without diabetes. Only among women aged <40 years (P = 0.0003) and people aged ≥80 years (P < 0.0001) did this IR decrease significantly.Conclusions: Incidence of chronic RRT remained significantly higher among people with diabetes. The IR decreased significantly in people with diabetes independent of age and sex. Time trends were inconsistent in people without diabetes. [ABSTRACT FROM AUTHOR]

Study Question: What is the agreement between antral follicle count (AFC) and anti-Müllerian hormone (AMH) levels when used to patient classification according to the Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number (POSEIDON) criteria?Summary Answer: Our study indicates a strong agreement between the AFC and the AMH levels in classifying POSEIDON patients; thus, either can be used for this purpose, although one in four women will have discordant values when both biomarkers are used.What Is Known Already: According to the POSEIDON criteria, both AFC and AMH may be used to classify low-prognosis patients. Proposed AFC and AMH thresholds of 5 and 1.2 ng/ml, respectively, have their basis in published literature; however, no study has yet determined the reproducibility of patient classification in comparing one biomarker with the other, nor have their thresholds ever been validated within this patient population.Study Design, Size, Duration: A population-based cohort study involving 9484 consecutive patients treated in three fertility clinics in Brazil, Turkey and Vietnam between 2015 and 2017.Participants/materials, Setting, Methods: Participants were infertile women between 22 and 46 years old in their first in vitro fertilization/intracytoplasmic sperm injection cycle of standard ovarian stimulation with exogenous gonadotropins whose baseline ovarian reserves had been assessed by both AFC and AMH. Details of pre- and post-treatment findings were input into a coded research file. Two indicators of interest were created to classify patients according to the POSEIDON criteria based upon AFC and AMH values. Patients who did not fit any of the four POSEIDON groups were classified as non-POSEIDON. AFC was determined in the early follicular phase using two-dimensional (2D) transvaginal ultrasonography, whereas AMH values were based on the modified Beckman Coulter generation II enzyme-linked immunosorbent assay. Agreement rates were computed between AFC and AMH to classify patients using Cohen's kappa statistics. Logistic regression analyzes were carried out to examine the association between ovarian markers and low (<4) and suboptimal (4-9) oocyte yield.Main Results and the Role Of Chance: The degree of agreement in classifying patients according to POSEIDON groups was strong overall (kappa = 0.802; 95% CI: 0.792-0.811). A total of 73.8% of individuals were classified under the same group using both biomarkers. The disagreement rates were ∼26% and did not diverge when AFC or AMH was used as the primary biomarker criterion. Significant regression equations were found between ovarian markers and oocyte yield (P < 0.0001). For low oocyte yield, the optimal AFC and AMH cutoff values were 5 and 1.27 ng/ml with sensitivities of 0.61 and 0.66, specificities of 0.81 and 0.72, and AUC receiver operating characteristics of 0.791 and 0.751, respectively. For suboptimal oocyte yield respective AFC and AMH cutoffs were 12 and 2.97 ng/ml with sensitivities of 0.74 and 0.69, specificities of 0.76 and 0.66 and AUCs of 0.81 and 0.80.Limitations, Reasons For Caution: Our study relied on 2D transvaginal sonography to quantify the AFC and manual Gen II assay for AMH determination and classification of patients. AMH data must be interpreted in an assay-specific manner. Treatment protocols varied across centers potentially affecting patient classification.Wider Implications Of the Findings: Three of four patients will be classified the same using either AFC or AMH values. Both biomarkers provide acceptable and equivalent accuracy in predicting oocyte yield further supporting their use and proposed thresholds in daily clinical practice for patient classification according to the POSEIDON criteria. However, the sensitivity of POSEIDON thresholds in predicting low oocyte yield is low. Clinicians should adopt the biomarker that may best reflect their clinical setting.Study Funding/competing Interest(s): Unrestricted investigator-sponsored study grant (MS200059_0013) from Merck KGaA, Darmstadt, Germany. The funder had no role in study design, data collection, analysis, decision to publish or manuscript preparation. S.C.E. declares receipt of unrestricted research grants from Merck and lecture fees from Merck and Med.E.A. H.Y. declares receipt of payment for lectures from Merck and Ferring. L.N.V. receives speaker fees and conferences from Merck, Merck Sharp and Dohme (MSD) and Ferring and research grants from MSD and Ferring. T.M.H. received speaker fees and conferences from Merck, MSD and Ferring. The remaining authors have nothing to disclose.Trial Registration Number: not applicable. [ABSTRACT FROM AUTHOR]

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

Aim: To explore parents' expectations of the perceived barriers to and benefits of 1 year of monthly video consultations combined with regular outpatient care of children with type 1 diabetes. Methods: The Virtual Diabetes Outpatient Clinic for Children and Youth (VIDIKI) study was a controlled, multicentre, perennial study with 240 participants from northern Germany. Fifty‐four qualitative interviews with parents were analysed using qualitative content analysis. Before the intervention, 30 interviews were conducted to assess parents' expectations, and after 1 year, 24 interviews evaluated the experienced benefits and barriers to video consultations. Results: Four main topics were identified from parents' responses to the video consultation. The main advantages of the video consultation compared with standard care were a higher frequency of contact for optimized insulin dosing and saving time; difficulties with internet connections were identified as the main barrier. A feeling of increased confidence with respect to insulin dosing was directly associated with telemedicine. Digital prescriptions and meeting the same diabetologist in both outpatient and telemedical care were mentioned as important improvements. The majority of interviewees preferred intervals of 4–6 weeks between video consultations. Conclusion: The higher frequency of contact with the diabetes team was considered a great relief by parents of children with type 1 diabetes. Apart from the time savings and flexibility in appointments, the most important advantages were the higher frequency of contact leading to short‐term therapy adjustments and an increase in the ability to adjust therapy independently. (German Clinical Trials Registry No: DRKS00012645). [ABSTRACT FROM AUTHOR]

Background Flow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long- term clinical and angiographic outcomes. Methods A prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0--1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3--5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale. Results Between July 2014 and February 2018, 119 patients were enrolled. Twenty- three patients were excluded. Ninety- six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1--3). Clinical follow- up at 18 months was available in 90 (94%) patients, resulting in a mean follow- up period of 14.8±5.2 months. At last available follow- up of 96 enrolled patients, 91 (95%) remained mRS 0--1. The major morbidity rate (mRS 3--5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow- up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89). Conclusion Our results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality. Trial registration DRKS00006103 [ABSTRACT FROM AUTHOR]

Objective: Weight stigma is prevalent across the world. However, little is known about whether and how the harmful health consequences of weight stigma may vary across countries. The current study examined the association between experiences of weight stigma and multiple eating and exercise-related indicators among a large, multinational sample of adults.Methods: Adults enrolled in an international weight management program residing in Australia, Canada, France, Germany, the United Kingdom, and the United States completed identical Web-based surveys in the dominant language for their country. Participants (N = 13,996) reported on their personal experiences of weight stigma and health, including eating behaviors, attitudes toward exercise, and perceived stress.Results: More than half of all participants in each country reported experiencing weight stigma. Participants who had experienced weight stigma reported engaging in more eating to cope, gym avoidance, and self-monitoring behaviors, as well as higher levels of stress and reduced eating self-efficacy. These associations were documented over and above sociodemographic characteristics and BMI and did not vary across countries.Conclusions: Study findings document uniform health-related correlates of weight stigma within a multinational context and underscore the need for global initiatives to curtail weight stigma in order to support population health. [ABSTRACT FROM AUTHOR]

Background: Although current guidelines advocate early integration of palliative care, symptom burden and palliative care needs of patients at diagnosis of incurable cancer and along the disease trajectory are understudied. Material and Methods: We assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer in a prospective longitudinal observational multicenter study. Patients were evaluated using validated self‐report measures (National Comprehensive Cancer Network Distress Thermometer [DT], Functional Assessment of Cancer Therapy [FACT], Schedule for the Evaluation of Individual Quality of Life [SEIQoL‐Q], Patients Health Questionnaire‐4 [PHQ‐4], modified Supportive Care Needs Survey [SCNS‐SF‐34]) at baseline (T0) and at 3 (T1), 6 (T2), and 12 months (T3) follow‐up. Results: From October 2014 to October 2016, 500 patients (219 women, 281 men; mean age 64.2 years) were recruited at 20 study sites in Germany following diagnosis of incurable metastatic, locally advanced, or recurrent lung (217), gastrointestinal (156), head and neck (55), gynecological (57), and skin (15) cancer. Patients reported significant distress (DT score ≥ 5) after diagnosis, which significantly decreased over time (T0: 67.2%, T1: 51.7%, T2: 47.9%, T3: 48.7%). The spectrum of reported symptoms was broad, with considerable variety between and within the cancer groups. Anxiety and depressiveness were most prevalent early in the disease course (T0: 30.8%, T1: 20.1%, T2: 14.7%, T3: 16.9%). The number of patients reporting unmet supportive care needs decreased over time (T0: 71.8 %, T1: 61.6%, T2: 58.1%, T3: 55.3%). Conclusion: Our study confirms a variable and mostly high symptom burden at the time of diagnosis of incurable cancer, suggesting early screening by using standardized tools and underlining the usefulness of early palliative care. Implications for Practice: A better understanding of symptom burden and palliative care needs of patients with newly diagnosed incurable cancer may guide clinical practice and help to improve the quality of palliative care services. The results of this study provide important information for establishing palliative care programs and related guidelines. Distress, symptom burden, and the need for support vary and are often high at the time of diagnosis. These findings underscore the need for implementation of symptom screening as well as early palliative care services, starting at the time of diagnosis of incurable cancer and tailored according to patients' needs. Guidelines recommend early integration of palliative care in the treatment of patients with advanced cancer. This study assessed distress, symptom burden, quality of life, and supportive care needs in patients with newly diagnosed incurable cancer to facilitate future implementation of more effective palliative care services. [ABSTRACT FROM AUTHOR]

Background: There is currently a wide therapeutic arsenal for migraine patients, without a single first-line preventive drug and we choose the different available alternatives taking into account comorbidities, national guidelines, previous treatments and personal experiences. Our objective was to evaluate the differences in the use of migraine treatments between neurologists from different countries. Methods: This is a multi-centre observational study carried out by neurologists from specialized headache units in seven countries, retrospective with consecutive inclusion of all patients presenting with a migraine diagnosis, over a period of three months. Results: A total of 734 patients were recruited but only 600 were considered in the analysis in order to homogenize the patient cohorts from countries: 200 Spain (ES), 100 Italy (IT), 85 Russia (RUS), 80 Germany (DE), 60 Portugal (PT), 45 Poland (PL) and 30 Australia (AU). 85.4 % of patients were women with a mean age of 42.6 ± 11.8 years. Considering previous and current preventive treatment, the order of use was: antidepressants (69.3 %), antiepileptic drugs (54.7 %), beta-blockers and antihypertensive drugs (49.7 %), OnabotulinumtoxinA (44.0 %) and others (36.2 %). Statistically significant differences were found between all pharmacological classes: antidepressants were commonly used in all countries, with the exception of Poland (AU: 76.7 %, IT: 71.0 %, DE: 60.0 %, PL: 31.1 %, PT: 71.7 %, RUS: 70.6 %, ES: 78.5 %; p < 0.0001); antiepileptic drugs were more frequently prescribed in Portugal, Australia and Spain (AU: 73.3 %, IT: 40.0 %, DE: 37.5 %, PL: 48.9 %, PT: 85.0 %, RUS: 29.4 % and ES: 69.0 %; p < 0.0001); beta-blockers and antihypertensive drugs were frequently used in all countries except Italy (AU: 60.0 %, IT: 14.0 %, DE: 53.8 %, PL: 48.9 %, PT: 68.3 %, RUS: 49.4 % and ES: 59.0 %; p < 0.0001); BTX-A were predominately used in Spain, Italy and Australia (AU:56.7 %, IT:58.0 %, DE:20.0 %, PL: 42.2 %, PT: 26.7 %, RUS: 24.7 % and ES: 58.5 %; p < 0.0001) and others were most frequently used in Poland (AU: 0.0 %, IT: 19.0 %, DE: 42.5 %, PL: 95.6 %, PT: 31.7 %, RUS: 3.5 % and ES: 49.5 %; p < 0.0001). If only patients without comorbidities are considered (200/600), statistically differences between countries persist in all preventive treatments. Conclusions: There is heterogeneity in the choice of preventive treatment between different countries. Prospective comparative studies of the different oral and subcutaneous alternatives would help to create a global therapeutic algorithm that would guarantee the best option for our patients. [ABSTRACT FROM AUTHOR]

Background: The shortage of qualified nurses is a problem of growing concern in many countries. Recruitment of internationally trained nurses has been used to address this shortage, but successful integration in the workplace is complex and resource intensive. For effective recruitment and retention, it is important to identify why nurses migrate and if their expectations are met to ensure their successful integration and promote a satisfying work climate for the entire nursing team. The aim of this study was to examine the perceptions of safety culture, work-life-balance, burnout and job demand of internationally trained nurses and associated host nurses in German hospitals. Methods: A multicentric, cross-sectional study was conducted with internationally trained nurses (n = 64) and host nurses (n = 103) employed at two university hospitals in the state of Baden-Wuerttemberg, Germany. An anonymous paper-based survey was conducted between August 2019 and April 2020. The questionnaire included sociodemographic questions, questions regarding factors related to migration, and the German version of the Assessment of your work setting Safety, Communication, Operational Reliability, and Engagement (SCORE) questionnaire. SCORE is divided into three sections: Safety Culture Domains (six subscales), Work-Life-Balance (one subscale), and Engagement Assessment Tool (four subscales). Results: Nurses who migrated to Germany were primarily seeking better working conditions, a higher standard of living, and professional development opportunities. Internationally trained nurses reported lower work-related burnout climate (Mean 55.4 (SD 22.5)) than host nurses (Mean 66.4 (SD 23.5)) but still at a moderately high degree (Safety Culture Domains). Host nurses indicated a higher workload (Mean 4.06 (SD 0.65)) (Engagement Assessment Tool) and a lower Work-Life-Balance (Mean 2.31 (SD 0.66)) (Work-Life-Balance) compared to nurses who trained abroad (Mean 3.67 (SD 0.81) and Mean 2.02 (SD 0.86), respectively). No differences were detected for the other subscales. The Safety Culture Domains and Engagement Assessment Tool showed room for improvement in both groups. Conclusion: The study suggest that the expectations migrant nurses had prior to migration may not be met and that in turn could have a negative impact on the integration process and their retention. With increasing recruitment of internationally trained nurses from within Europe but also overseas, it is crucial to identify factors that retain migrant nurses and assist integration. Trial registration: The study has been prospectively registered (27 June 2019) at the German Clinical Trial Register (DRKS00017465). [ABSTRACT FROM AUTHOR]

Immune checkpoint inhibition (ICI) triggers immune-related adverse events (irAEs). The relevance of lipase elevation remains unclear. Skin cancer patients with newly detected serum lipase elevation (at least twofold upper normal limit) or newly diagnosed type I diabetes mellitus upon ICI therapy were retrospectively collected at 14 German skin cancer centres. We identified 68 patients with lipase elevation occurring after a median time of 19 (range 1–181) weeks on ICI, 15 (22%) thereof had symptoms consistent with pancreatitis. Forty-seven patients (73%) had other irAE, mainly colitis. Discontinuation (n = 24, 35%) or interruption (n = 26, 38%) of ICI resulted in decrease of lipase after reinduction of ICI lipase levels increased again in 12 of 24 patients. In 18 patients (27%), ICI was continued unchanged, and in 12 (67%) of them, lipase levels normalised. Twenty-two patients were identified with newly diagnosed type I diabetes mellitus related to ICI, and 12 (55%) thereof had also lipase elevation mainly shortly before or after the diagnosis of diabetes. Fourteen (64%) patients had other irAE, mainly thyroiditis. Irrespective of lipase elevation, patients frequently showed a rapid onset with ketoacidosis, decreased c-peptide, and strongly increased blood glucose levels. Increased serum lipase during ICI is often not associated with pancreatitis but with other irAE as possible cause. Therefore, it might be sufficient to regularly monitor blood glucose levels and perform further workup only in case of signs or symptoms of pancreatitis and/or exocrine pancreas insufficiency. • Lipase elevation is often associated with e.g. colitis but not pancreatitis. • Immune checkpoint inhibition diabetes occurs often with endocrine immune-related adverse event and in 50% with lipase elevation. • Lipase elevation shortly precedes the onset of type I diabetes mellitus. • Therefore, blood glucose but not lipase monitoring is recommended. [ABSTRACT FROM AUTHOR]

Background: Smell, taste and trigeminal disorders likely have a substantial impact on human daily life. However, data regarding the prevalence of these disorders in Norway are scarce. The aim of this study was to investigate the prevalence of smell, taste, trigeminal disorders and associated factors in a 65-year-old population in Oslo, Norway.Methods: A random sample of 223 individuals (123 men, 100 women) participated in the study. Medical history was obtained, and unstimulated whole saliva (UWS) and stimulated whole saliva (SWS) were collected to determine salivary secretion rates. Sniffin`n Sticks and Taste Strips (Burghart Messtechnik GmbH, Wedel, Germany) were used for quantitative testing of olfactory and gustatory function. In addition, the participants' self-reported perceptions of smell and taste, and burning mouth sensation were investigated.Results: The results showed that 34 % of the participants had reduced smell (28 % hyposmia and 6 % anosmia) and 28 % had reduced taste perception (21 % hypogeusia and 7 % ageusia). 13 % of the partcipants had a combination of smell and taste disorders. Dysgeusia was reported by 5 % and burning mouth sensation (syndrome) by 3 % of the participants. Hyposmia, hypogeusia and ageusia were significantly more prevalent among men. Significant associations were found between taste disorders and previous history of cerebral hemorrhage and heart attack, and between burning mouth sensation and gastrointestinal disorders. Disturbances in olfactory, gustatory and trigeminal function were significantly related to medication use. Ageusia and burning mouth sensation were significantly more prevalent among smokers. Except from higher prevalence of ageusia among participants with hyposalivation with respect to SWS, no significant associations were found between salivary secretion rate and chemosensory or trigeminal disorders in the present study.Conclusions: The present study revealed that one-third of 65-year-old individuals had impaired smell and more than one-fourth had impaired taste function. The prevalence of dysgeusia and burning mouth sensation was very low. Reduced smell and taste perception were more common among men than women. Furthermore, some diseases and medications were associated with chemosensory and trigeminal disorders. Ageusia was associated with SWS hyposalivation. [ABSTRACT FROM AUTHOR]

Background: Whole-body vibration training (WBV) performed on a vibration platform can significantly improve physical performance in patients with chronic obstructive pulmonary disease. It has been suggested that an important mechanism of this improvement is based on an improvement in balance. Therefore, the aim of this study was to investigate the effects of WBV compared to conventional balance training.Methods: 48 patients with severe COPD (FEV1: 37 ± 7%predicted) and low exercise performance (6 min walk distance (6MWD): 55 ± 10%predicted) were included in this randomized controlled trial during a 3 week inpatient pulmonary rehabilitation. All patients completed a standardized endurance and strength training program. Additionally, patients performed 4 different balance exercises 3x/week for 2 sets of 1 min each, either on a vibration platform (Galileo) at varying frequencies (5-26 Hz) (WBV) or on a conventional balance board (BAL). The primary outcome parameter was the change in balance performance during a semi tandem stance with closed eyes assessed on a force measurement platform. Muscular power during a countermovement jump, the 6MWD, and 4 m gait speed test (4MGST) were secondary outcomes. Non-parametric tests were used for statistical analyses.Results: Static balance performance improved significantly more (p = 0.032) in favor of WBV (path length during semi-tandem stand: - 168 ± 231 mm vs. + 1 ± 234 mm). Muscular power also increased significantly more (p = 0.001) in the WBV group (+ 2.3 ± 2.5 W/kg vs. - 0.1 ± 2.0 W/kg). 6MWD improved to a similar extent in both groups (WBV: 48 ± 46 m, p < 0.001 vs. BAL: 38 ± 32 m; p < 0.001) whereas the 4MGST increased significantly only in the WBV-group (0.08 ± 0.14 m/s2, p = 0.018 vs. 0.01 ± 0.11 m/s2, p = 0.71).Conclusions: WBV can improve balance performance and muscular power significantly more compared to conventional balance training.Trial Registration: Clinical-Trials registration number: NCT03157986; date of registration: May 17, 2017. https://clinicaltrials.gov/ct2/results?cond=&term=NCT03157986&cntry=&state=&city=&dist  = . [ABSTRACT FROM AUTHOR]

Background: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days.Objectives: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial.Methods: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites.Results: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63).Conclusions: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150). [ABSTRACT FROM AUTHOR]

Background: Cervical artery dissection is a major cause of stroke in young people (aged <50 years). Historically, clinicians have preferred using oral anticoagulation with vitamin K antagonists for patients with cervical artery dissection, although some current guidelines-based on available evidence from mostly observational studies-suggest using aspirin. If proven to be non-inferior to vitamin K antagonists, aspirin might be preferable, due to its ease of use and lower cost. We aimed to test the non-inferiority of aspirin to vitamin K antagonists in patients with cervical artery dissection.Methods: We did a multicentre, randomised, open-label, non-inferiority trial in ten stroke centres across Switzerland, Germany, and Denmark. We randomly assigned (1:1) patients aged older than 18 years who had symptomatic, MRI-verified, cervical artery dissection within 2 weeks before enrolment, to receive either aspirin 300 mg once daily or a vitamin K antagonist (phenprocoumon, acenocoumarol, or warfarin; target international normalised ratio [INR] 2·0-3·0) for 90 days. Randomisation was computer-generated using an interactive web response system, with stratification according to participating site. Independent imaging core laboratory adjudicators were masked to treatment allocation, but investigators, patients, and clinical event adjudicators were aware of treatment allocation. The primary endpoint was a composite of clinical outcomes (stroke, major haemorrhage, or death) and MRI outcomes (new ischaemic or haemorrhagic brain lesions) in the per-protocol population, assessed at 14 days (clinical and MRI outcomes) and 90 days (clinical outcomes only) after commencing treatment. Non-inferiority of aspirin would be shown if the upper limit of the two-sided 95% CI of the absolute risk difference between groups was less than 12% (non-inferiority margin). This trial is registered with ClinicalTrials.gov, NCT02046460.Findings: Between Sept 11, 2013, and Dec 21, 2018, we enrolled 194 patients; 100 (52%) were assigned to the aspirin group and 94 (48%) were assigned to the vitamin K antagonist group. The per-protocol population included 173 patients; 91 (53%) in the aspirin group and 82 (47%) in the vitamin K antagonist group. The primary endpoint occurred in 21 (23%) of 91 patients in the aspirin group and in 12 (15%) of 82 patients in the vitamin K antagonist group (absolute difference 8% [95% CI -4 to 21], non-inferiority p=0·55). Thus, non-inferiority of aspirin was not shown. Seven patients (8%) in the aspirin group and none in the vitamin K antagonist group had ischaemic strokes. One patient (1%) in the vitamin K antagonist group and none in the aspirin group had major extracranial haemorrhage. There were no deaths. Subclinical MRI outcomes were recorded in 14 patients (15%) in the aspirin group and in 11 patients (13%) in the vitamin K antagonist group. There were 19 adverse events in the aspirin group, and 26 in the vitamin K antagonist group.Interpretation: Our findings did not show that aspirin was non-inferior to vitamin K antagonists in the treatment of cervical artery dissection.Funding: Swiss National Science Foundation, Swiss Heart Foundation, Stroke Funds Basel, University Hospital Basel, University of Basel, Academic Society Basel. [ABSTRACT FROM AUTHOR]