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Annemarie Klingenstein,1 Christina Samel,2 Christoph Hintschich1 1Department of Ophthalmology, Ludwig-Maximilians-University, Klinikum der Universität München, Campus Innenstadt, Munich, D-80336, Germany; 2Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, D-50924, GermanyCorrespondence: Annemarie Klingenstein, Tel +49 89 44005 3811, Fax +49 89 44005 5160, Email Annemarie.Klingenstein@med.uni-muenchen.deAim: To assess the potential danger of belated diagnosis or underdiagnosis of cutaneous infraorbital pathologies that are partially or fully covered by face masks worn due to the COVID-19 pandemic.Methods: We evaluated data of 257 patients with infraorbital pathologies presenting at a large tertiary German university center between 04/2020 and 06/2021. This mono-centric, retrospective analysis included descriptive statistics and non-parametric tests.Results: Out of 257 cutaneous infraorbital pathologies, 32 (12.5%) were partially and 20 (7.8%) fully covered by the required face mask. Significantly more patients with lesions that were partially or fully covered came from a single household (p=0.003, Fisher’s exact test) with 125 (48.6%) patients reportedly living alone. In patients with multiple periocular pathologies (n = 51, 19.8%), the risk of at least one periocular lesion being covered by the face mask was significantly elevated (p=0.009, Fisher’s exact test). As expected, malignant tumors were significantly larger than benign pathologies (largest diameter, malignant median 9.0mm, range 1.3– 34.0mm, mean 10.5mm, and benign median 3.0mm, range 1.0– 7.0mm, mean 4.3mm, respectively; p< 0.001, Mann–Whitney-U test) and patients presenting with malignant lesions were significantly older (median age 78.4, range 33– 93, mean 73.7 years versus median age 57.9, range 18– 90, mean 59.8 years, respectively; p< 0.001, Mann–Whitney-U test). Additionally, in subgroup analysis, patients with malignant lesions coming from single households were significantly older (p=0.041, Mann–Whitney-U test).Conclusion: For adequate and timely treatment of infraorbital lesions, patients should be examined without their face mask. This is of utmost importance for the elderly (being at greater risk for malignant pathologies) and patients coming from single households. The presence of multiple pathologies must always be excluded.Trial Registration Number: Not applicable.Keywords: eyelid tumors, infraorbital, face mask, COVID-19 pandemic

Annemarie Klingenstein,1 Christina Samel,2 Aylin Garip-Kuebler,1 Siegfried G Priglinger,1 Paul I Foerster1 1Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany; 2Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, GermanyCorrespondence: Annemarie KlingensteinDepartment of Ophthalmology, Ludwig-Maximilians-University, Klinikum der Universität München, Campus Innenstadt, Mathildenstraße 8, Munich D-80336, GermanyTel +49 89 44005 3811Fax +49 89 44005 5160Email Annemarie.Klingenstein@med.uni-muenchen.deAim: To assess a profile of uveal melanoma patients at risk of requiring active psycho-oncological intervention by employing the National Comprehensive Cancer Network (NCCN) distress thermometer.Methods: Multivariate correlation and multiple linear regression analysis of data collected retrospectively from 106 consecutive patients suffering from uveal melanoma.Results: Distress levels correlated with practical (p = 0.01), emotional (p = 0.003) and physical problems (p = 0.001) as well as the total number of issues reported (p < 0.001; ANOVA, respectively). Emotional issues added up to 39% of influence on distress levels. Nervousness, worry and sadness as the most important emotional issues tested correlated significantly with anatomic stage, tumor T-category, metastatic status and time after primary diagnosis and were present more frequently in patients with higher distress levels (p < 0.001, p = 0.002, p = 0.004, respectively, Fisher’s exact test). Pre-existing psycho-oncological support was more frequent in metastatic patients and patients with higher anatomic stage tumors (p = 0.008 and p = 0.003; Fisher’s exact test).Conclusion: The distress thermometer proved to be useful for rapid assessment of patients requiring active intervention. A higher number of distress items recorded correlated with elevated distress levels. Emotional issues were responsible for the majority of problems. A typical patient profile at risk of developing distress requiring close attention of caregivers includes high anatomic stage, high T-category, presence of metastases and early follow-up. Correct diagnosis and interpretation of distress-levels should help improve the quality of life of uveal melanoma survivors.Trial Registration: Not applicable.Keywords: quality of life, NCCN distress thermometer, uveal melanoma, psycho-oncological distress, cancer

Martin Röhling,1,* Marcus Redaélli,2,* Dusan Simic,2 Kristina Lorrek,2 Christina Samel,3 Paul Schneider,4 Kerstin Kempf,1 Stephanie Stock,2 Stephan Martin1,5 1West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany; 2Institute of Health Economics and Clinical Epidemiology, University Hospital of Cologne, Cologne, Germany; 3Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany; 4Düsseldorf Catholic Hospital Group, Düsseldorf, Germany; 5Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany*These authors contributed equally to this workCorrespondence: Martin RöhlingWest-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Hohensandweg 37, Düsseldorf 40591, GermanyTel +49 211-56 60 360 76Fax +49 211-56 60 360 72Email martin.roehling@vkkd-kliniken.deIntroduction: The proportion of hospitalized patients with diabetes as a secondary diagnosis increases continuously. Therefore, we have developed a team-based interprofessional and telemedicine-based diabetes management system named TeDia (“Telemedical Diabetology”) and implemented it in an inpatient setting. The aim of the retrospective real-world study was to show the clinical impact of TeDia following its implementation.Material and methods: TeDia is characterized by an interpersonal and telemedicine-based exchange of hospital routine data between specially trained nurses (“diabetes managers”) and external diabetologists. It was implemented in three acute hospitals of the Düsseldorf Catholic Hospital Group in Düsseldorf, Germany. Clinical awareness of diabetes, diabetes-related complications and diagnosis-related group (DRG)-based revenues were analyzed using ICD routine coding. Furthermore, the frequency of HbA1c determinations as well as hospitalization days were investigated.Results: Before (2010), during (2012) and after the implementation of TeDia (2014), the number of patients with ICD coding for diabetes, decompensated diabetes, diabetic neuropathy, diabetic nephropathy as well as complicated diabetes increased by +18%, +93%, +101%, +113% and +89%, respectively. Using the same DRG grouper, revenues increased by +53% (from 27 (2013) to 42 (2014) DRG points). Frequency of HbA1c determinations rose by +85%, whereas the time for an average length of stay decreased by −12% (−0, 91 days) in comparison to patients without diabetes.Conclusion: TeDia improved clinical awareness for diabetes and its complications. This new treatment model increased revenues and reduced hospital days indicating enhanced treatment quality. Our findings emphasize the necessity of novel technologies in inpatient settings for the improvement of efficacy, safety and efficiency of diabetes care.Keywords: telemedicine, diabetes, inpatient care

Objectives: To describe an epidemic of vancomycin-resistant Enterococcus faecium causing bacteremia and bacteriuria, to identify the source of infection, to delineate risk factors associated with acquisition of the organism, and to determine antibiotic sensitivities for the organism.Design: Investigation of an epidemic, including a case-control study.Setting: Medical-surgical intensive care unit and ward in a university medical center.Patients: Nine patients infected or colonized with vancomycin-resistant Enterococcus faecium and 20 noninfected controls.Measurements: Clinical data, environmental surveillance cultures, and in-vitro microbiologic studies.Results: Colonization or infection by vancomycin-resistant E. faecium was associated with an increased duration of treatment with ceftazidime, 13.2 compared with 4.6 days, and a greater number of nonisolated days of hospitalization in the intensive care unit, 19.9 compared with 6.4 days for infected and noninfected patients, respectively (P less than 0.05). Environmental surveillance cultures recovered the organism repeatedly from the rectal probe handles of three electronic thermometers used exclusively on nonisolated patients in the intensive care unit. Restriction endonuclease analysis of plasmid DNA showed that all clinical and environmental isolates were identical. Infection control measures, including isolation of colonized or infected patients and removal of the rectal thermometer probes suspected to be responsible for transmission, resulted in termination of the outbreak. In-vitro, time-kill studies showed that the combination of ciprofloxacin, rifampin, and gentamicin resulted in bactericidal activity against the organism.Conclusions: This nosocomial outbreak of infection due to a highly vancomycin-resistant strain of Enterococcus is the first epidemic in which an electronic thermometer has been implicated as the vehicle of transmission for an infectious agent. [ABSTRACT FROM AUTHOR]

Pressure variations on a train predominantly occur while trains are passing through tunnels. These aerodynamic effects may give rise to aural discomfort in railway passengers. We conducted a field study on the high speed railway track Cologne-Frankfurt/Main as well as a simulation study in our pressure chamber TITAN (DLR-Institute of Aerospace Medicine) with 31 subjects (mean age = 37.7, SD = 12.7; 51.6% male) to investigate pressure comfort for passengers. Continuous assessments of pressure events using sliders and retrospective assessments were acquired. Pressure variations were mostly tolerated. A comparison of field and laboratory setting revealed high congruency of continuous as well as retrospective assessments. A generalized estimating equation model identified pressure change attributes contributing to passengers' discomfort. Beside attributes of instantaneous pressure changes (e.g. high amplitudes, short durations), pressure events of the recent past significantly influenced current discomfort. Design engineers may use these findings to improve train and tunnel design. [ABSTRACT FROM AUTHOR]

Objective. To quantify the exposure-response relationship between hand-arm vibration exposure and the risk of musculoskeletal disorders of the upper extremities (UMSDs), a case-control study was carried out among workers in the construction, mining, metal and woodworking industries. Methods . In total, 209 male cases and 614 controls were recruited. Cases were newly reported patients with UMSDs. Controls were a random sample of persons with compensable occupational injuries. Standardized personal interviews were performed among cases and controls by well-trained safety engineers. In addition to leisure activities and comorbidities, work histories of all participants were collected in detail. To quantify hand-arm vibration exposures, a database of vibration measurements of over 700 power tools was used. This database allows the detailed quantification of vibration exposures over time. A dose-response relationship between hand-arm vibration exposure and UMSDs was quantified by conditional logistic regression analyses. Results and conclusions . After adjusting for relevant confounders, statistically significant exposure-response relationships between cumulative hand-arm vibration exposure and UMSDs were established. A cumulative hand-arm vibration exposure of D hv (vibration total value in three measuring directions) = 142,300 (95% confidence interval [CI] [90,600-333,200]) m 2 /s 4 ·day or D hw (vibration value in the direction along the forearm) = 38,700 (95% CI [25,400-80,900]) m 2 /s 4 ·day is associated with a doubled risk of UMSDs.

Background: Following guidelines for cardiovascular disease prevention of the European Society for Cardiology (ESC), the current study validated the German Comprehensive Psychosocial Screening Instrument in participants who underwent coronary angiography. Methods: 314 participants (M age = 69.7 ± 12.0; 69 % male) completed the German Comprehensive Psychosocial Screening Instrument and validated comparison scales to measure depression (PHQ-9), anxiety (GAD-7), Type D personality (DS14), work stress (ERI), family stress (SMSS), trauma (PC-PTSD), and anger and hostility (Z-scale of MMPI-2). Results: Confirmatory factor analysis (CFA) confirmed that the psychosocial risk factors were separate entities rather than a signs or symptoms of a single broad indication of distress (CFI = .872, RMSEA = .056, SRMR = .058). Intraclass coefficients (ICC), kappa and diagnostic accuracy indicators (receiver operator characteristic [ROC] curves, sensitivity, specificity, and the positive and negative predictive values [PPV; NPV]) indicated that most screener scales were sufficient to good. We also compared patients with established coronary heart disease (CHD; n = 213) to those with no current CHD (n = 100) and found overall similar results. Discussion: The German version of the Comprehensive Psychosocial Screening Instrument has an acceptable performance. Aside from minor improvements, the screening instrument could be implemented in the cardiological practice to screen patients on multidimensional psychosocial risk.

Introduction: Outpatient parenteral antimicrobial therapy (OPAT) means intravenous administration of antibiotics outside the hospital. The antibiotics are administered at the patient's home. The advantages are the shortening of the inpatient stay, which means that patients can remain in their familiar environment, the reduction of nosocomial infections as well as the reduction of hospital and therapy costs. Nevertheless, OPAT is rarely performed in Germany, despite its international application. Therefore, systematic data on OPAT are not available in Germany. The project objective is to investigate the medical care using OPAT under medical, epidemiological and economic aspects within the framework of the Cologne Network of Infectious Diseases., Methods and Analysis: Observational study with mixed-methods approach, qualitative analysis to identify physician-side factors to assess the attitude of general practitioners in Cologne with regard to possible implementation barriers of an OPAT. Longitudinal analysis of an OPAT patient cohort with respect to clinical and patient-relevant outcomes using descriptive and conclusive statistics., Ethics and Dissemination: The study has been approved by the Institutional Review Board of the University of Cologne, Germany (19-1284-1). Written informed consent was obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences., Trial Registration Number: NCT04002453., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The randomized controlled trial (RCT) is the gold standard in evidence-based medicine. However, this design may not be appropriate in every setting, so other methods or designs such as the regression discontinuity design (RDD) are required., Method: The aim of this article is to introduce the RDD, summarise methodology in the context of health services research and present a worked example using the statistic software SPSS (Examples for R and Stata in the Appendix A). The mathematical notations of sharp and fuzzy RDD as well as their distinction are presented. Furthermore, examples from the literature and recent studies are highlighted, and both advantages and disadvantages of the design are discussed., Application: The RDD consists of four essential steps: 1. Determine feasibility; 2. Note possible treatment manipulation, 3. Check for the treatment effect, and 4. Fit the regression models to measure the treatment effect., Conclusion: The RDD comes as an alternative for studies in health service research where an RCT cannot be conducted, but a threshold-based comparison can be made., (Copyright © 2022. Published by Elsevier GmbH.)

Background/aims: To assess epidemiological tumour features, risk factors, clinical management and outcome of eyelid squamous cell carcinoma (SCC) and changes thereof. Furthermore, we searched for validating predictors of the American Joint Committee on Cancer (AJCC) 8 classification system., Methods: We evaluated data of 117 patients with histologically proven eyelid SCC at a large tertiary German university centre between January 2009 and March 2020. This retrospective, monocentric analysis included descriptive statistics and non-parametric tests (p<0.05)., Results: Histologically controlled excision and follow-up was performed in 88 (75.2%) patients. In the remaining patients with higher T-category, individual adjuvant therapy combinations were initiated. We found higher numbers of nodal metastasis and recurrence for male patients and higher T-category (p=0.035, p=0.008 and p=0.001, p<0.001). Recurrence rates proved higher for patients with multiple lesions (p=0.008). Disease-specific survival (DSS) was 95.7% at 2 and 94.9% at 5 years of follow-up. Six patients (5.1%) died from eyelid SCC with nodal metastasis and higher T-category being negative prognostic factors (p<0.001 and p=0.009). Mortality was associated with tumour location in the medial upper eyelid, nodal metastasis being more frequent (p=0.001 and p=0.009) and tumour of the lower eyelid alone as positive predictor (p=0.012). T category differed in 34 (29.1%) patients when comparing AJCC 7 and 8 (p<0.001). Changes in T category as per the AJCC 8 classification resulted in better prediction of DSS (p=0.024)., Conclusion: Special attention should be paid to male patients, tumour location in the upper medial eyelid and lymph node diagnostics. Prediction of DSS proved superior as per the AJCC 8 staging system., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: As individuals with thalidomide embryopathy now reaching their 60's they undergo long-term sequelae of their prenatal damage and experience a wide range of secondary health problems, in particular chronic musculoskeletal pain, movement restrictions, and mental disorders. These health problems are having a negative impact on their life circumstances and their health-related quality of life (HRQOL)., Objective: The aim of this study was to determine the HRQOL in individuals with thalidomide embryopathy in comparison to individuals of the age-adjusted general population in Germany with and without chronic disease conditions (primary outcome). And, further explore the influence of impairment patterns, pain stage, and mental disorders on physical and mental dimensions of HRQOL (secondary outcome)., Methods: A cross-sectional survey of 202 individuals with thalidomide embryopathy from North Rhine-Westphalia/Germany was conducted, which gathered information about physical examinations including a standardized determination of the pain stage, a structured psychological interview, and the HRQOL. The final dataset was 186 cases for primary outcome., Results: Individuals with thalidomide embryopathy (50.6 years, 55.9% females) show a significantly reduced physical HRQOL comparison to the age-adjusted German population with chronic diseases (physical component score; pcs: 33.4 vs. 45.3, p < .001). In addition, male individuals with thalidomide embryopathy show a significantly reduced mental HRQOL to their male counterparts in this comparison (mental component score; mcs: 45.0 vs. 50.0, p = .005). The subgroup analyses show that individuals with thalidomide embryopathy with quadruple impairment have a significantly lower physical HRQOL than those with hearing loss (pcs: 25.0 vs. 38.5; ci's not overlapping). Second, individuals with thalidomide embryopathy with severe compared to mild stages of pain have significantly poorer levels of physical and mental HRQOL (pcs: 25.8 vs. 37.7, ci not overlapping; mcs: 40.4 vs. 51.8, ci's not overlapping). And, individuals with thalidomide embryopathy without a mental disorder show a high mental HRQOL (mcs: 53.2), while in comparison to the total sample those with somatoform and personality disorders have a significantly reduced physical HRQOL (pcs: 27.5 and 24.8; both ci's not overlapping), and those with depressive disorders have a significant reduced mental HRQOL (mcs: 38.0 vs. 45.8, ci's not overlapping)., Conclusions: A longitudinal decreasing HRQOL in individuals with thalidomide embryopathy is known, as well as high prevalence of mental disorders and chronic pain syndromes. This study shows a strong association between these two influencing factors and a poor HRQOL., (© 2022 The Authors. Birth Defects Research published by Wiley Periodicals LLC.)

There is empirical evidence of an association between periodontitis and coronary heart disease (CHD). However, it is uncertain whether periodontal treatment in CHD patients might lead to reduced healthcare costs. This study aims to assess the association between periodontal treatment and healthcare costs in newly diagnosed CHD patients. Data from 21,263 adults who were continuously insured between 2011 and 2016 and who were newly diagnosed with CHD in 2013 were selected from a German claims database. The study population was differentiated by the utilization of periodontal treatment. The average treatment effect (ATE) of periodontal treatment on healthcare costs (total, inpatient, outpatient, drugs) was investigated using weighted Poisson regression models conditional on covariates and is shown as a ratio (of geometric means). Periodontal treatment was documented for 4.7% of the persons in the study population. Newly diagnosed CHD patients showed an ATE of 0.98 for total healthcare cost (95% CI 0.90-1.06), 0.79 for inpatient costs (95% CI 0.61-1.04), and 0.95 for drug costs (95% CI 0.87-1.04). A statistically significant 7% increase in outpatient costs was shown (95% CI 1.01-1.13). Despite a lack of statistical significance in most cases, the study provides evidence of a meaningful decrease in inpatient costs after periodontal treatment. Further studies are needed.

Background: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system., Methods: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations., Results: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system., Discussion: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system., Trial Registration: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018., (© 2022. The Author(s).)

Musculoskeletal disorders (MSDs) are among the most common cause for reduced work capacity and sick leave. Workplace health promotion programs are often neither tailored to the workplace nor the individual needs of the employees. To counteract lacking intersectional care, this four-year randomized controlled trial (RCT) aimed to investigate the effects of modular coordinating case management (treatment group) compared to supported self-management (control group) on MSD specific sick leave days (routine data), workability (WAI), self-efficacy (self-efficacy scale), and pain (German pain questionnaire, GPQ). The study network comprised 22 companies, 15 company health insurance funds, and 12 pension funds in Germany. Overall, 852 participants (Module A/early intervention: n = 651, Module B/rehabilitation: n = 190, Module C/reintegration: n = 10) participated. Both groups achieved fewer sick leave days, higher workability, and less pain ( p < 0.0001) at follow-up compared to baseline. At follow-up, the coordinating case management group showed fewer disability days (GPQ), lower disability scores (GPQ), and lower pain intensities (GPQ) than the supported self-management group ( p < 0.05), but no superiority regarding MSD specific sick leave days, workability, nor self-efficacy. Module A showed more comprehensive differences. The accompanying process evaluation shows barriers and facilitators for the implementation of the program, especially in a RCT setting.

Background: Progress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care., Methods: The study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher)., Discussion: The OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments' effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating., Trial Registration: German Clinical Trials Register (DRKS) DRKS00016737 ( https://www.drks.de/DRKS00016737 ). Registered 17 September, 2019., (© 2021. The Author(s).)

Objective: The aim of the study was to show the frequency, localisation, intensity, quality and degree of chronic pain in people with thalidomide-induced congenital defects (thalidomide embryopathy) and to investigate the association with biopsychosocial factors more closely., Methods: A group of 202 people from North Rhine-Westphalia with thalidomide embryopathy were studied for the first time both physically for the pattern of the original damage and also psychiatrically in a structured diagnostic interview (SCID I & SCID II). The results were combined with a standardized pain interview (MPSS) and questionnaires on further pain-related (SF-36, painDETECT) and sociodemographic variables and analysed. In the analysis 167 completed datasets were included., Results: The prevalence of pain in the sample population was 94%. The majority (107, 54.0%) already showed an advanced stage of chronicity in the MPSS: 63 subjects with Stage II (37.7%) and 44 with Stage III (26.3%). In 74 subjects (44.3%) the PainDetect score showed a possible or neuropathic pain component. The factors that most reliably influenced the chronicity of pain proved to be hip pain (p<0.001) and also mental health disorders (p=0.001), above major depression (p<0.001) and also somatic symptom disorders and substance-related disorders (p=0.001 in each case). Social variables proved non-significant here (p=0.094 for living alone, p=0.122 for unemployment, p=0.167 for lack of college education), as did the care situation (p=0.191 for care dependency) and the underlying pattern of organ damage (p=0.229 for damage to hearing, p=0.764 for dysmelia)., Conclusions: People with thalidomide defects frequently suffer from a separate pain disorder which can be seen as secondary thalidomide-induced damage and which requires specialized and personalized multimodal pain management., Competing Interests: K. M. Peters hat Honorare für Referententätigkeit der Firmen Amgen und Kyowa Kirin erhalten. Die anderen Autorinnen/Autoren erklären, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Staphylococci producing exfoliative toxins are the causative agents of staphylococcal scalded skin syndrome (SSSS). Exfoliative toxin A (ETA) is encoded by eta , which is harbored on a temperate bacteriophage ΦETA. A recent increase in the incidence of SSSS in North America has been observed; yet it is largely unknown whether this is the result of host range expansion of ΦETA or migration and emergence of established lineages. Here, we detail an outbreak investigation of SSSS in a neonatal intensive care unit, for which we applied whole-genome sequencing (WGS) and phylogenetic analysis of Staphylococcus aureus isolates collected from cases and screening of healthcare workers. We identified the causative strain as a methicillin-susceptible S. aureus (MSSA) sequence type 582 (ST582) possessing ΦETA. To then elucidate the global distribution of ΦETA among staphylococci, we used a recently developed tool to query extant bacterial WGS data for biosamples containing eta , which yielded 436 genomes collected between 1994 and 2019 from 32 countries. Applying population genomic analysis, we resolved the global distribution of S. aureus with lysogenized ΦETA and assessed antibiotic resistance determinants as well as the diversity of ΦETA. The population is highly structured with eight dominant sequence clusters (SCs) that generally aligned with S. aureus ST clonal complexes. The most prevalent STs included ST109 (24.3%), ST15 (13.1%), ST121 (10.1%), and ST582 (7.1%). Among strains with available data, there was an even distribution of isolates from carriage and disease. Only the SC containing ST121 had significantly more isolates collected from disease (69%, n = 46) than carriage (31%, n = 21). Further, we identified 10.6% (46/436) of strains as methicillin-resistant S. aureus (MRSA) based on the presence of mecA and the SCC mec element. Assessment of ΦETA diversity based on nucleotide identity revealed 27 phylogroups, and prophage gene content further resolved 62 clusters. ΦETA was relatively stable within lineages, yet prophage variation is geographically structured. This suggests that the reported increase in incidence is associated with migration and expansion of existing lineages, not the movement of ΦETA to new genomic backgrounds. This revised global view reveals that ΦETA is diverse and is widely distributed on multiple genomic backgrounds whose distribution varies geographically., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Azarian, Cella, Baines, Shumaker, Samel, Jubair, Pegues and David.)

Purpose: Vertebral osteomyelitis (VO) has a high mortality and leads to chronic pain and functional disability. Surgical treatment is often necessary. To date, little is known about the consequences of surgery on patient outcome. The aim of this study was to determine the quality of life (QoL) and mortality rates of surgically treated VO patients for a period of 2 years., Methods: Patients with VO undergoing surgical treatment in a tertiary referral hospital from 2008 to 2015 were included prospectively. Data were collected before (T0) as well as 1 year (T1) and 2 years (T2) post-surgery. Within the European Spine Tango registry, prospective patient and QoL data were collected using validated outcome scores: Oswestry Disability Index, Short Form 36/EuroQol, Visual Analog Scale, and Core Outcome Measures Index., Results: From 195 patients surgically treated for VO, QoL data were available from 136 patients at T0, 100 patients at T1, and 82 patients at T2, respectively. The 1- and 2-year mortality rates were 20% and 23%. Mainly all QoL outcome scores showed significant improvement at T1 and did not change significantly from T1 to T2., Conclusion: Surgical treatment of VO patients leads to significantly improved QoL. Nevertheless, QoL levels were below those of the general population. Our results underscore that spine disability questionnaires measuring QoL are mandatory to demonstrate comprehensively the severity of this entity. Our study confirms a high mortality and points out the role of VO as a potentially life-threatening condition., (© 2020. The Author(s).)

Background: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences., Methods: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data., Discussion: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them., Trial Registration: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.

Background: There is debate regarding criteria to select patients for lumbar fusion surgery who have chronic low back pain (CLBP) and corresponding degenerative changes, but without nerve root compression or neurogenic claudication. The aim of this study was to compare patterns in current practice., Method: A total of 143 printed questionnaires containing 51 questions were distributed at the German Spine Societies' (DWG) annual congress, 6-8 December 2018., Results: We received 127 (89%) surveys (64 orthopedic surgeons and 63 neurosurgeons). Excluding the 22% who do not perform lumbar fusion for CLBP, 41.4% reported performing 1-10 lumbar fusion procedures for patients with CLBP per year, 20.2% reported 11-20, 10.1% reported 21-30 and 17.2% reported performing more than 50. A total of 44.9% of surgeons reported treating patients for at least 6-12 months conservatively before considering surgery; 65.6% considered postoperative pain reduction of 50-70% a treatment success; 32.6% of respondents believe that <50% of patients showed good outcomes after fusion in CLBP and only 15.5% believed that 70% or more showed good outcomes. Orthopedic surgeons perform more lumbar fusion surgeries than neurosurgeons (p = 0.05), fuse more lumbar segments than neurosurgeons (p = 0.02) and are more likely to suggest that their patients with CLBP cease smoking preoperatively (p = 0.02)., Conclusions: Despite discouraging evidence in the literature, the majority of respondents still perform fusion surgery in patients with CLBP. The use of preoperative diagnostics and tests vary widely among spine surgeons.

Aims: There is sufficient scientific evidence for the bidirectional association between periodontal diseases and diabetes. In this context, we hypothesized that periodontal treatment leads to lower healthcare costs in newly diagnosed diabetes patients by promoting a milder disease course., Methods: A total of 23,771 persons were investigated who were continuously insured by German health insurances between 2011 and 2016, 18 years or older, and newly diagnosed with diabetes in 2013. The study population was divided into a periodontal treatment and control group (no periodontal treatment). The average treatment effect of a periodontal treatment on various types of healthcare costs (inpatient, outpatient, drug costs) was analyzed by a doubly robust method., Results: Finally, 5.3% of the study population could be assigned to the treatment group. In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group., Conclusions: This study provides evidence that periodontal treatment for diabetes patients reduces healthcare costs. Fewer diabetes-specific complications and hospitalizations are expected., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose: To assess quality of life (QoL) status via the National Comprehensive Cancer Network (NCCN) distress thermometer as a psychooncological screening tool in uveal melanoma patients., Methods: One hundred and six consecutive patients suffering from uveal melanoma completed the distress thermometer between 04/2018 and 12/2018. Practical, emotional, family concerned, spiritual, physical and overall distress levels, distribution of distress and subgroup analyses defining groups of potential high distress levels in need of intervention were assessed. Descriptive statistics, cross-tabulations, chi-square and Fisher's exact test as well as correlation coefficients (Spearman's rho) and receiver operating characteristic (ROC) were used for analysis., Results: Patients with higher T-category had significantly more emotional problems and spiritual concerns (p = 0.046 and p = 0.023, respectively). Female patients accounted for higher rates of physical issues (p = 0.034). Lower best corrected visual acuity (BCVA) was correlated with higher distress levels (p = 0.037). Patients resulting in loss of BCVA of ≥3 lines reported higher distress levels (p = 0.029). A distress threshold of 5 on the basis of ROC analysis showed a corresponding sensitivity of 100% and specificity of 76%., Conclusion: The NCCN distress thermometer could be integrated well into our clinical routine and proved to be a rapid, yet sensible screening tool for emotional and physical distress in patients with uveal melanoma. Special attention should be paid to patients with higher T-category and patients resulting in lower levels of BCVA. As in patients with different tumour entities, the established distress threshold of ≥5 proposing intervention proved to be adequate for uveal melanoma patients., (© 2019 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Introduction: International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare., Methods and Analysis: The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study., Ethics and Dissemination: The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations., Trial Registration Number: DRKS00015326; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To assess cancer detection rates of different target-dependent transperineal magnetic resonance (MR)/ultrasonography (US) fusion-guided biopsy templates with reduced number of systematic cores., Patients and Methods: Single-centre outcome of transperineal MR/US fusion-guided biopsies of 487 men with a single target MR imaging (MRI) lesion, prospectively collected between 2012 and 2016. All men underwent transperineal targeted biopsy (TB) with two cores, followed by 18-24 systematic sector biopsies (SB) using the Ginsburg protocol. Gleason score ≥7 prostate cancer detection rates for two-core TB, four-core extended TB (eTB), 10- to 20-core saturation TB (sTB) including cores from sectors adjacent to the target, and 14 core ipsilateral TB (iTB) were compared to combined TB+SB., Results: Cancer was detected in 345 men and Gleason score 7-10 cancer in 211 men. TB alone detected 67%, eTB 76%, sTB 91% and iTB 91% of these Gleason score 7-10 cancers. In the subgroup of 33 men (7% of cohort) with an anterior >0.5 mL highly suspicious MRI lesion and a prostate volume ≤45 mL, four-core eTB detected 31 of 32 cancers (97%) and all 26 Gleason score 7-10 cancers., Conclusion: sTB detected Gleason score 7-10 cancer in 25% more of the men than a two-core TB approach, and in almost as many men (91%) as the 20-26-core combined TB+SB, while needing only 10-20 cores. A four-core extended TB may suffice for large, highly suspicious anterior lesions in small or slightly enlarged prostates., (© 2019 The Authors BJU International Published by John Wiley & Sons Ltd on behalf of BJU International.)

Background: Prognostic scores have been proposed to guide the treatment of patients with metastatic spine disease (MSD), but their accuracy and usefulness are controversial. The aim of this study was to evaluate seven such prognostic scoring systems. The following prognostic scores were compared: Tomita, Van der Linden (VDL), Bauer modified (BM), Oswestry Spinal Risk Index (OSRI), Tokuhashi original (T90), Tokuhashi revised (TR05), and modified Tokuhashi revised (TR17)., Methods: We retrospectively reviewed all our patients who underwent surgery for spinal metastases, February 2008-January 2015. We classified all 223 patients into the predicted survival-time categories of each of the 7 scoring systems and then tallied how often this was correct vis-à-vis the actual survival time. Accuracy was also assessed using receiver operating characteristic (ROC) analysis at 1, 3, and 12 months., Results: The median (95% CI) survival of the 223 patients was 13.6 (7.9-19.3) months. A groupwise ROC analysis showed sufficient accuracy for 3-month survival only for TR17 (area under the curve [AUC] 0.71) and for 1-year survival for T90 (AUC 0.73), TR05 (AUC 0.76), TR17 (AUC 0.76), Tomita (AUC 0.77), and OSRI (AUC 0.71). A pointwise ROC score analysis showed poor prognostic ability for short-term survival (1 and 3 months) with sufficient accuracy for T90 (AUC 0.71), TR05 (AUC 0.71), TR17 (AUC 0.71), and the Tomita score (AUC 0.77) for 1-year survival., Conclusion: The TR17 was the only prognostic system with acceptable performance here. More sophisticated assessment tools are required to keep up with present and future changes in tumor diagnostics and treatment.

Background: Paediatric dialysis patients still suffer from high morbidity rates. To improve this, quality assurance programs like the German QiNKid (Quality in Nephrology for Children)-Registry have been developed. In our study, the significance of underlying renal disease on a range of clinical and laboratory parameters impacting morbidity and mortality was analysed. Our aim was to evaluate whether or not disease-specific dialysis strategies should be considered in planning dialysis for a patient., Methods: Inclusion criteria were defined as follows: (1) CAKUT (congenital anomalies of the kidney and urinary tract) or glomerular disease patient, (2) < 18 years of age, (3) haemodialysis or peritoneal dialysis patient. Only measurements obtained from day 90 to 365 after the date of the first dialysis in the registry were analysed. Laboratory (serum albumin, haemoglobin, ferritin, calcium, phosphate, parathyroid hormone) and clinical parameters (height, blood pressure) were analysed using mixed effects models accounting for the correlation of repeated measures in individual patients., Results: The study cohort comprised n = 167 CAKUT and n = 55 glomerular disease patients. Glomerular disease patients had significantly higher odds of hypoalbuminemia (OR 13.90, 95% CI 1.35-159.99; p = 0.0274), anaemia (OR 3.31, 95% CI 1.22-9.13; p = 0.0197), hyperphosphatemia (OR 9.69, 95% CI 2.65-37.26; p = 0.0006) and diastolic hypertension (OR 3.38, 95% CI 1.20-9.79; p = 0.0212)., Conclusions: Glomerular disease patients might require more intensive dialysis regimens. The evaluation of hydration status should be given more attention, since conditions differing between the cohorts can be linked to overhydration. The QiNKid-Registry allows monitoring of the quality of paediatric dialysis in a nationwide cohort.

Upcoming challenges in providing care for thalidomide impaired individuals Abstract. Background: Between 1957 and 1962 an approximate 5000 children were born in Germany with severe birth defects as their mothers took the substance Thalidomide during pregnancy as a sedative and effective relief from morning sickness. Objective: The aim of this study was to describe the care and assistance needed by the individuals impaired by Thalidomide and indicate upcoming challenges. A further aim was to determine the association between the impairment type and the care needed. Methods: Cross sectional study, 202 individuals impaired by Thalidomide were examined by two orthopedists as well as surveyed via questionnaire. They were also evaluated mentally by either a psychiatrist or psychotherapist. The need for care was determined by the acquired legal status for long-term care. Results: The sample divides roughly into two groups: the ones with impairments in their extremities and those who are not affected in their extremities. Many of the ones affected in their extremities are already dependent on assistance and need to be nursed. Those who are depending on assistance and care are mostly informally cared for. Conclusions: The prevalence for long-term care is already higher than in the age-adjusted general population in Germany, while formal care is underutilized. Therefore a challenge will be to make a shift from informal care to professional care providers as the informally caring (sometimes actually the parents of the impaired) are aging along with the ones they care for.

Introduction: Patients with end-stage kidney failure can be treated either by transplant or by dialysis, which can be administered as haemodialysis (HD) or peritoneal dialysis (PD). Although they are equivalent therapeutic options in terms of mortality, the percentage of patients in Germany treated with PD is currently very low (∼6%) compared with other countries. The aim of our study is to analyse the factors behind this percentage and their relevance to the choice of dialysis treatment in Germany. This includes analyses of regional disparities in the provision of care for dialysis patients as well as the evaluations of costs and the influence of reimbursement structures. This approach should provide further insights to explain the variation in the usage of PD and HD and will help to define starting points for future interventions., Methods and Analysis: A mixed-methods approach will be applied to several data sources, including administrative data (ambulatory physicians' claim data, statutory health insurance claim data), quality assurance data from one of the largest German dialysis providers Kuratorium für Dialyse (KfH) and qualitative and quantitative survey data (patients, nephrologists and dialysis nurses). Qualitative data will be analysed content-analytically. Based on the quantitative data, multivariable analyses will be performed and, where possible, hierarchical models will be tested. This multidimensional approach will enable us to account for the different factors influencing the penetration of PD in Germany., Ethics and Dissemination: Ethics approval (17-299) has been obtained from the Ethics Committee of the Medical Faculty of the University of Cologne on 25 April 2018. National and international dissemination will be accomplished by informing healthcare practitioners, patients and professional organisations and other stakeholders via conferences, scientific and non-scientific publications and seminars., Trial Registration Number: DRKS00012555; Pre-Results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Between 1957 and 1961 the substance Thalidomide was sold in West Germany and taken by many women as a sedative during pregnancy. This lead to miscarriages and infants been born with several severe malformations. The aim of this study was to describe the current situation of women impaired by Thalidomide induced embryopahty in North Rhine-Westphalia (Nordrhein-Westfalen), Germany, in comparison with the results found in a study done in 2002 by Nippert et al. METHODS: Questionnaires as well as examinations were performed. Data were compared using descriptive and inductive statistical methods., Results: Both studies show that women impaired by Thalidomide embryopathy face a poorer health status than women their age in the general population and live in fear of further deteriorating health. The majority can only work reduced hours or are already retired due to poor health. Most of those who need assistance are being assisted by their social environment, while professional care is still utilized in only few cases., Conclusions: An obvious need for a shift in the provision of assistance and/or care provided was found as the social environment supporting the impaired women is also aging and therefore in high danger of breaking apart., Trial Registration: The study has been registered at German Clinical Trials Register, DRKS00010593 , on 07.06.2016 retrospectively.

Objectives: Nurses are generally found to be vulnerable to burnout, but nurses working in cancer care are even more so, since this profession is characterised by continuous confrontation with suffering and death. This study was designed to identify cut-off scores for job strain, that is, low job control and high job demands, for a sample of nurses working in breast cancer care. The main goal was to find cut-off scores, which predict the risk of nurses of developing a mental disorder from high job strain., Design: The design was a cross-sectional survey study., Setting: The study is based on an employee survey in breast cancer centres in Germany., Participants: 688 nurses received a questionnaire; 329 nurses from 33 hospitals participated in the survey (return rate: 50.2%)., Primary and Secondary Outcome Measures: Dependent variable: psychological well-being, measured by the WHO-5 Well-being Index; independent variables: job control and job demands, measured by the Job Content Questionnaire (JCQ)., Results: Multivariable analysis indicates that low job control and high job demands are prognostic factors for low well-being. In a receiver operating curve (ROC) analysis, the cut-off scores, which demonstrated a maximum Youden index, were 34.5 for job control and 31.4 for job demands. The combination of both scales from a logistic regression analysis resulted in an area under the curve of 0.778. Sensitivity and specificity are 70.3% and 74.2%, respectively. The total of correct classification was 63.3%., Conclusion: The determined cut-off scores indicate that there is a risk of becoming psychologically ill from a high workload when an individual reaches a score of ≤34.5 for job control and ≥31.4 for job demands. The described method of establishing risk-based cut-off scores is promising for nursing practice and for the field of occupational health. Transferability and generalisability of the cut-off scores should be further analysed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To analyse the detection rates of primary magnetic resonance imaging (MRI)-fusion transperineal prostate biopsy using combined targeted and systematic core distribution in three tertiary referral centres., Patients and Methods: In this multicentre, prospective outcome study, 807 consecutive biopsy-naïve patients underwent MRI-guided transperineal prostate biopsy, as the first diagnostic intervention, between 10/2012 and 05/2016. MRI was reported following the Prostate Imaging-Reporting and Data System (PI-RADS) criteria. In all, 236 patients had 18-24 systematic transperineal biopsies only, and 571 patients underwent additional targeted biopsies either by MRI-fusion or cognitive targeting if PI-RADS ≥3 lesions were present. Detection rates for any and Gleason score 7-10 cancer in targeted and overall biopsy were calculated and predictive values were calculated for different PI-RADS and PSA density (PSAD) groups., Results: Cancer was detected in 68% of the patients (546/807) and Gleason score 7-10 cancer in 49% (392/807). The negative predictive value of 236 PI-RADS 1-2 MRI in combination with PSAD of <0.1 ng/mL/mL for Gleason score 7-10 was 0.91 (95% confidence interval ± 0.07, 8% of study population). In 418 patients with PI-RADS 4-5 lesions using targeted plus systematic biopsies, the cancer detection rate of Gleason score 7-10 was significantly higher at 71% vs 59% and 61% with either approach alone (P < 0.001). For 153 PI-RADS 3 lesions, the detection rate was 31% with no significant difference to systematic biopsies with 27% (P > 0.05). Limitations include variability of multiparametric MRI (mpMRI) reading and Gleason grading., Conclusion: MRI-based transperineal biopsy performed at high-volume tertiary care centres with a significant experience of prostate mpMRI and image-guided targeted biopsies yielded high detection rates of Gleason score 7-10 cancer. Prostate biopsies may not be needed for men with low PSAD and an unsuspicious MRI. In patients with high probability lesions, combined targeted and systematic biopsies are recommended., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Background: More than 50 years after the withdrawal of thalidomide from the market, subsequent orthopedic damages and psychosocial impairments dominate the complaints of thalidomide-affected individuals. The aim of the study was to determine the prevalence of mental disorders in this group., Methods: A total of 193 thalidomide-affected individuals from North Rhine-Westphalia (mean age 50.5 years, 56.5% women) underwent personal and comprehensive psychodiagnostic testing, which was based on the Structured Clinical Interview for DSM-IV disorders (SCID-I & SCID-II) and self-reporting questionnaires., Results: Overall, the four-week prevalence of mental disorders was 47.2%. Multiple mental disorders were present in 45.1% among the 91 participants with diagnosed mental disorders. The most frequent diagnoses were unipolar depressive disorders (16.5%), somatoform disorders (14.0%), phobic disorders (12.4%), and alcohol-related disorders (6.2%). Immediate mental health care was indicated in 80.2% of participants with current mental disorders, but only 29.7% had used some form of psychosocial treatment in the 12 months preceding the study., Conclusion: Mental disorders occur approximately twice as often (relative risk [RR]: 1.77; 95% confidence interval [1.49; 2.10]) in thalidomide-affected individuals as in the age-matched German population. Together with a very low rate of utilization of mental health care, this finding implies an underuse of psychosocial healthcare. The development of specialized psychosocial treatment services may remove barriers that impede access to the healthcare system.

Background: Hygiene deficits can cause hospital-acquired infections. To meet this public health problem the Robert Koch-Institute advocates the employment of infection control link nurses (ICLN). Aim: This study aimed to evaluate the experiences of ICLNs working in the University Hospital of Cologne. Method: A cross-sectional survey of all ICLNs (n = 64) working at the University Hospital of Cologne was carried out by a self developed questionaire. The data were assessed descriptively. Results: The return rate was 45.3 % (n = 29). The ICLNs were very satisfied with the ICLN training and felt well prepared for their task. The collaboration with other nursing staff, their head nurse and the Department of Hygiene was also positively evaluated. However, only one third of the respondents was satisfied with their working conditions and only half of them indicated feeling that the efforts they made so far were successful. This study also found that, many of the legal intended services were rarely performed. The study identified two barriers to implementation of ICLNs. On the one hand, the release from other routine nursing duties and on the other hand a lack of acceptance of the role by physicians. Conclusions: The task ahead is to find ways to exempt ICLNs from other duties and to involve the physicians more intensely in the implementation of ICLNs.

Background: Hospital-acquired infections (HAI) still pose a major problem in inpatient care. The single most important measure for preventing HAIs is to improve adherence to hand hygiene among health care professionals., Objective: To assess the feasibility of an innovative hands-on training to improve adherence to hygiene rules under standardized and under real life conditions., Design: Before-after controlled cohort trial to assess the feasibility of implementing an innovative hands-on training to improve hand hygiene adherence., Setting: Large university hospital in Germany., Participants: Fifty trained nurses from three wards with an average age of 32years (±10.22years) and an average vocational experience of 6.85years (±7.54years)., Methods: The intervention consisted of a hands-on training in the skills lab of the University of Cologne complemented by a 12-week observation period before and after the training on participating wards. The training comprised important skills with respect to hand hygiene, venipuncture, dressing changes of central venous catheters, preparation of IV infusions, and donning of gloves using sterile technique. A communication training was included to enable nurses to enforce hygiene rules in their collaboration with peers and physicians. The intervention was taught in small groups with a wide array of interactive teaching methods. It was evaluated using the objective structured clinical examination (OSCE) format. Observations were conducted by a trained infection control nurse., Results: Before (after) the intervention 622 (612) occasions of hand hygiene were documented. A highly significant improvement in hygiene compliance was observed pre- and post-intervention (64.3% vs. 79.2%; p≤0.0001). The OSCE evaluation showed significant improvements in all subscales., Conclusion: The developed and conducted hands-on training seems feasible and is successful in significantly improving adherence to hygiene rules under standardized and real life conditions. Whether the effect is stable over time is subject to further investigation., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Acute otitis media (AOM) is one of the main reasons for medical consultation and antibiotic use during childhood. Although 80% of AOM cases are self-limiting, antibiotic prescription is still high, either for physician- or for parent-related factors. This study aims to identify parental knowledge about, beliefs and attitudes towards, and experiences with AOM and its therapy and thus to gain insights into parents' perspectives within the German health care system., Methods: An exploratory survey was conducted among German-speaking parents of children aged 2 to 7 years who sent their children to a childcare facility. Childcare facilities were recruited by convenience sampling in different urban and rural sites in Germany, and all parents with children at those facilities were invited to participate. Data were evaluated using descriptive statistical analyses., Results: One-hundred-thirty-eight parents participated. Of those, 75.4% (n = 104) were AOM-experienced and 75.4% (n = 104) had two or more children. Sixty-six percent generally agree that bacteria cause AOM. 20.2% generally agree that viruses cause AOM. 30.5% do not generally agree that viruses cause AOM. Eight percent generally agree that AOM resolves spontaneously, whereas 53.6% do not generally agree. 92.5% generally (45.7%) and partly (42.8%) agree that AOM needs antibiotic treatment. With respect to antibiotic effects, 56.6% generally agree that antibiotics rapidly relieve earache. 60.1% generally agree that antibiotics affect the gastrointestinal tract and 77.5% generally agree that antibiotics possibly become ineffective after frequent use. About 40% generally support and about 40% generally reject a "wait-and-see" strategy for AOM treatment. Parental-reported experiences reveal that antibiotics are by far more often prescribed (70.2%) than actively requested by parents (26.9%)., Conclusions: Parental views on AOM, its therapy, and antibiotic effects reveal uncertainties especially with respect to causes, the natural course of the disease and antibiotic effects on AOM. These results indicate that more evidence-based information is needed if parents' health literacy in the treatment of children with AOM is to be enhanced. The discrepancy between reported parental requests for antibiotics and reported actual prescriptions contradicts the hypothesis of high parental influence on antibiotic use in AOM.

Background: Primary health care-associated bloodstream infections (PHA-BSIs) affect as many as 350 000 patients in the United States annually. Whereas gram-negative organisms were the leading cause before the 1970s, gram-positive organisms have been the predominant microbial isolates since then., Methods: We identified all PHA-BSIs among adult inpatients in a 625-bed quaternary care hospital from January 1, 1996, through December 31, 2003, and evaluated trends in the microbial etiology, geographic distribution within the institution, and antimicrobial susceptibilities., Results: A total of 3662 PHA-BSIs caused by 4349 bacterial and fungal isolates were identified. From 1999 to 2003, the proportion of PHA-BSIs due to gram-negative organisms increased from 15.9% to 24.1% (P<.001 for trend). This trend was not significantly different across various units of the hospital, and no specific gram-negative species contributed disproportionately to the increase. With few exceptions, there were no significant increases in antimicrobial resistance. The increase in gram-negative organisms was accompanied by a decline in the proportion of PHA-BSIs from coagulase-negative staphylococci (from 33.5% in 1999 to 29.9% in 2003, P = .007) and from Staphylococcus aureus (from 18.8% in 1999 to 11.8% in 2003, P = .004). The proportion of PHA-BSIs from Candida species almost doubled from 5.8% in 1999 to 11.3% in 2003 (P = .002)., Conclusions: To our knowledge, this is the first US study to report a reemergence of gram-negative organisms as a cause of PHA-BSIs. This finding does not seem to be related to changes in specific gram-negative organisms or to antimicrobial resistance. If this trend continues, it will have important implications for the management of bloodstream infections.

Enterobacter hormaechei was first identified as a unique species in 1989. Between 29 November 1992 and 17 March 1993, an outbreak of E. hormaechei occurred among premature infants in the intensive care nursery (ICN) at The Hospital of the University of Pennsylvania. The 10 infants whose cultures were positive for E. hormaechei (six were infected and four were colonized) had a lower median estimated gestational age and birth weight than did other ICN infants; other risk factors for infection or colonization with E. hormaechei were not identified. Cultures from three isolettes and a doorknob in the ICN were positive for E. hormaechei. Pulsed-field gel electrophoresis of isolates from six patients and two isolettes were identical. Observations of health care workers revealed breaks in infection control techniques that may have allowed transmission of this organism. We found that E. hormaechei is a nosocomial pathogen that can infect vulnerable hospitalized patients and that can be transmitted from patient to patient when infection control techniques are inadequate.