Validity of a German Comprehensive Psychosocial Screening Instrument based on the ESC Cardiovascular Prevention Guidelines.

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 (Mage = 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.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

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.

Progress feedback in children and adolescents with internalizing and externalizing symptoms in routine care (OPTIE study): study protocol of a randomized parallel-group trial.

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.

Quality of life and mortality after surgical treatment for vertebral osteomyelitis (VO): a prospective study.

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.

The effects of webcams on German neonatal intensive care units - study protocol of a randomised crossover trial (Neo-CamCare).

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.

Current patterns of practice in spinal fusion for chronic low back pain-results from a survey at the German Spine Societies' Annual Congress 2018.

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.

[Chronic Pain in People Impaired by Thalidomide Embryopathy: An Explorative Analysis of Prevalence, Pain Parameters and Biopsychosocial Factors]. / Chronische Schmerzen bei Menschen mit Thalidomid-Embryopathie Eine explorative Analyse zu Prävalenz, schmerzbezogenen Merkmalen und biopsychosozialen Faktoren.

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.

Optimising the number of cores for magnetic resonance imaging-guided targeted and systematic transperineal prostate biopsy.

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.

Analysis of seven prognostic scores in patients with surgically treated epidural metastatic spine disease.

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.

Glomerular disease patients have higher odds not to reach quality targets in chronic dialysis compared with CAKUT patients: analyses from a nationwide German paediatric dialysis registry.

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.

Life situation of women impaired by Thalidomide embryopathy in North Rhine-Westphalia - a comparative analysis of a recent cross-sectional study with earlier data.

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.

[Upcoming challenges in providing care for thalidomide impaired individuals]. / Behindertenspezifische Herausforderungen bei der pflegerischen Versorgung von contergangeschädigten Menschen ­ eine Bedarfsanalyse.

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.

Multicentre evaluation of magnetic resonance imaging supported transperineal prostate biopsy in biopsy-naïve men with suspicion of prostate cancer.

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.

Hygiene trained nursing staff at wards ­ What can this additional educated nurses achieve? / Hygienebeauftragte in der Pflege auf den Stationen. Erste Erfahrungen zur Einführung im Universitätsklinikum Köln

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.

Parental views on acute otitis media (AOM) and its therapy in children--results of an exploratory survey in German childcare facilities.

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.

Exposure-response relationship between work-related hand-arm vibration exposure and musculoskeletal disorders of the upper extremities: the German hand-arm vibration study.

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 Dhv (vibration total value in three measuring directions) = 142,300 (95% confidence interval [CI] [90,600-333,200]) m2/s4·day or Dhw (vibration value in the direction along the forearm) = 38,700 (95% CI [25,400-80,900]) m2/s4·day is associated with a doubled risk of UMSDs.

The regression discontinuity design: Methods and implementation with a worked example in health services research.

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.

Potential Delay of Diagnosing Infraorbital Skin Tumors Due to Coverage by Face Masks During the COVID-19 Pandemic: An Observational Study.

Aim: 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.

Association between Periodontal Treatment and Healthcare Costs in Patients with Coronary Heart Disease: A Cohort Study Based on German Claims Data.

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.

Health-related quality of life after 50 years in individuals with thalidomide embryopathy: Evidence from a German cross-sectional survey.

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.