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Background: Person-centred care (PCC) has been suggested as the preferred model of dementia care in all settings. The EPCentCare study showed that an adapted PCC approach was difficult to implement and had no effect on prescription of antipsychotics in nursing home residents in Germany. This paper reports the qualitative process evaluation to identify facilitators and barriers of the implementation of PCC in German nursing homes from the perspective of participating practice development champions. Methods: Five individual and 14 group interviews were conducted with 66 participants (staff and managers) from 18 nursing homes. The analysis was based on inductive coding to identify factors influencing the PCC implementation process. Identified factors were systematised and structured by mapping them to the four constructs (coherence, cognitive participation, collective action, reflexive monitoring) of the Normalization Process Theory (NPT) as a framework that explains implementation processes. Results: Facilitating implementation factors included among others broadening of the care perspective (coherence), tolerance development within the care team regarding challenging behaviour (cognitive participation), testing new approaches to solutions as a multi-professional team (collective action), and perception of effects of PCC measures (reflexive monitoring). Among the facilitating factors reported in all the NPT constructs, thus affecting the entire implementation process, were the involvement of relatives, multi-professional teamwork and effective collaboration with physicians. Barriers implied uncertainties about the implementation and expectation of a higher workload (coherence), concerns about the feasibility of PCC implementation in terms of human resources (cognitive participation), lack of a person-centred attitude by colleagues or the institution (collective action), and doubts about the effects of PCC (reflexive monitoring). Barriers influencing the entire implementation process comprised insufficient time resources, lack of support, lack of involvement of the multi-professional team, and difficulties regarding communication with the attending physicians. Conclusions: The findings provide a comprehensive and detailed overview of facilitators and barriers structured along the implementation process. Thus, our findings may assist both researchers and clinicians to develop and reflect more efficiently on PCC implementation processes in nursing homes. Trial registration: ClinicalTrials.gov identifier: NCT02295462; November 20, 2014. [ABSTRACT FROM AUTHOR]

Aim: To investigate nursing/midwifery students, Clinical Mentors, Link Teachers and Head Nurses experiences within "Dedicated Education Unit" model in 6 European clinical placements and analyse the necessary elements for a powerful clinical learning environment. Design: A multi‐country, phenomenological, qualitative study. Methods: Focus group interviews were performed to identify the personal and organizational factors of importance for students and nurses/midwives. Results: Data analysis produced 4 main themes (1) Clinical placement organization, (2) students' clinical knowledge and skill acquisition, (3) students, and nurses/midwives' experiences within the DEU model and (4) factors for creating an effective learning environment. Conclusions: A close educational‐service collaboration, a realistic clinical placement planning, a focus on student learning process and an investment in professionals' education and development among others, are elements to set up a powerful clinical learning environment. Implications for the profession: It is considered advisable and urgent to improve the working conditions of nurses/midwives and the learning environments of students as a strategy to alleviate the global shortage of nurses and respond to the increasingly demanding health needs of the population. Impact: Due to the close relationship between students' learning and features of the clinical environment nurse educators seek innovative models which allow students to manage patient care and their transition to professional practice. To implement new learning strategies, identifying students, nurses and midwives perceptions and suggestions is a powerful information to evaluate implementation process and outcomes. Public Contribution: Our findings could help academic and clinical managers to meet the human and organizational requirements to create a successful learning environment in every student placement. [ABSTRACT FROM AUTHOR]

Background: Liver transplantation is the only established, causally directed treatment for irreversible chronic or acute liver failure. Methods: This review is based on papers retrieved by a selective search in the PubMed database, the index of randomized controlled trials of the European Society of Organ Transplantation, and the Cochrane database, along with an analysis of data from the authors' own center. Results: 1199 liver transplantations were performed in Germany in 2011. The most common indications were alcoholic cirrhosis (28%), cirrhosis of other causes (24%), and intrahepatic tumors (20%). Among recipients, the sex ratio was nearly 1:1 and the median age was just under 50. Across Europe, the 1-, 5-, and 10-year survival rates after liver transplantation were 82%, 71% and 61%. In our own center, the Charité in Berlin, the corresponding rates were 90.4%, 79.6% and 70.3%, based on an experience of 100 to 120 cases per year. The current rate of functioning transplants five years after liver transplantation is 52.6% in Germany and 66.2% internationally. Standard immunosuppression consists of a calcineurin inhibitor, tacrolimus or cyclosporine A, and steroids. Early complications include primary functional failure of the transplant, hemorrhage, thrombosis, acute rejection, and biliary complications. Over the long term, complications that can impair the outcome include chronic rejection, biliary strictures, cardiovascular and metabolic adverse effects, nephrotoxicity, neurotoxicity, and opportunistic infections and malignancies. Conclusion: Liver transplantation is a successful and wellestablished form of treatment that is nonetheless endangered by a shortage of donor organs and other structural and organizational difficulties. [ABSTRACT FROM AUTHOR]

Copyright of GMS Medizinische Informatik, Biometrie und Epidemiologie is the property of German Medical Science Publishing House gGmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Rheumatoid arthritis (RA) is an autoimmune disease that currently has an unknown cause and pathogenesis, and is associated with many complications and a high disability rate. The neutrophil extracellular trap network (NETs) is a newly discovered mechanism that allows neutrophils to capture and kill pathogens. Multiple studies in recent years have highlighted its relevance to the progression of rheumatoid arthritis. Despite the growing number of studies indicating the crucial role of NETs in RA, there has been no bibliometric review of research hotspots and trends in this area. In this study, we retrieved articles related to NETs in RA from the Web of Science Core Collection (WoSCC) database from 1985 to 2023 and used visualization tools such as Citespace, VOSviewer, Tableau Public, and Microsoft Office Excel 2021 to analyze the data. After screening, we included a total of 416 publications involving 2,334 researchers from 1,357 institutions in 167 countries/regions, with relevant articles published in 219 journals. The U.S., China, and Germany are the top 3 countries/regions with 124, 57, and 37 publications respectively. Mariana J. Kaplan is the most published author, and journals such as Frontiers in Immunology and International Journal of Molecular Sciences have had a significant impact on research in this field. The clinical application of PAD enzymes and their inhibitors, and the drug development of NETs as therapeutic targets for RA is a trend for future research. Our study provides a comprehensive bibliometric analysis and summary of NETs in RA publications, which will aid researchers in conducting further scientific research. [ABSTRACT FROM AUTHOR]

Rudolf Virchow's teaching was challenged by German physicians in the 1920s. Scientific medicine, they argued, did not provide sufficient tools for patient care. They held Virchow responsible for this state of things. According to Ludolf von Krehl, Gustav von Bergmann or Ferdinand Sauerbruch, Virchow fostered a mechanistic trend in medicine which neglected the human dimension in medical practice. These clinicians claimed that scientific medicine should therefore be complemented at the bedside by a teleological approach, taking into account the purposiveness of vital processes. This was the methodological core of the reform that they intended to promote. Many pathologists alike were preoccupied with the reformatory trend launched by the physicians. Ludwig Aschoff, Paul Ernst, Max Borst and Walter Pagel endeavoured to reform the theoretical foundations of their discipline. However, they did not agree with the physicians' view of Virchow's teaching. Aschoff especially showed that Virchow's initial writings provided in fact an epistemological basis supporting the clinicians' endeavour. In this paper, I examine Aschoff's argumentation. I hope thereby to improve our knowledge of one of the components of the medical reform which took place in Germany during the Weimar period.

Colorectal cancer (CRC) is a leading cause of cancer-related deaths worldwide. The best method to prevent CRC is with a colonoscopy. During this procedure, the gastroenterologist searches for polyps. However, there is a potential risk of polyps being missed by the gastroenterologist. Automated detection of polyps helps to assist the gastroenterologist during a colonoscopy. There are already publications examining the problem of polyp detection in the literature. Nevertheless, most of these systems are only used in the research context and are not implemented for clinical application. Therefore, we introduce the first fully open-source automated polyp-detection system scoring best on current benchmark data and implementing it ready for clinical application. To create the polyp-detection system (ENDOMIND-Advanced), we combined our own collected data from different hospitals and practices in Germany with open-source datasets to create a dataset with over 500,000 annotated images. ENDOMIND-Advanced leverages a post-processing technique based on video detection to work in real-time with a stream of images. It is integrated into a prototype ready for application in clinical interventions. We achieve better performance compared to the best system in the literature and score a F1-score of 90.24% on the open-source CVC-VideoClinicDB benchmark. [ABSTRACT FROM AUTHOR]

Background: Demographic trends show an increasing number of elderly people and thus a growing need for palliative care (PC). Such care is increasingly being provided by long-term care (LTC) facilities. The present study aimed at exploring PC indicators of residents at LTC facilities belonging to a non-profit provider in Lower Saxony, Germany, in order to identify potential improvements. Methods: A descriptive cross-sectional study was conducted, drawing on routine nursing chart data. Structural data from 16 participating LTC facilities and the care data of all residents who died in 2019 (N = 471) were collected anonymously between March and May 2020. Based on key literature on quality indicators of PC in LTC facilities in Germany, a structured survey was developed by a multidisciplinary research team. The descriptive, comparative and inferential data analysis was conducted using the SPSS software package. Results: In total, the complete records of 363 (77%) residents who died in the participating LTC facilities in 2019 were retrieved. The records reflected that 45% of the residents had been hospitalized at least once during the last 6 months of their lives, and 19% had died in hospital. Advance care planning (ACP) consultation was offered to 168 (46%) residents, and 64 (38%) declined this offer. A written advance directive was available for 47% of the residents. A specialized PC team and hospice service volunteers were involved in caring for 6% and 14% of the residents, respectively. Cancer patients received support from external services significantly more frequently (p <.001) than did non-cancer patients. Differences emerged in the distribution of PC indicators between LTC facilities. Facilities that have more PC trained staff offered more ACP, supported by more specialized PC teams and hospice services, and had fewer hospitalizations. In addition, more volunteer hospice services were offered in urban facilities. Conclusions: Overall, a rather positive picture of PC in participating LTC facilities in Germany emerged, although there were differences in the expression of certain indicators between facilities. ACP consultation, volunteer hospice services, and hospital admissions appeared to be superior in LTC facilities with more trained PC staff. Therefore, PC training for staff should be further promoted. [ABSTRACT FROM AUTHOR]

(1) Background: Uncertainty is typical for a pandemic or similar healthcare crisis. This affects patients with resulting decisional conflicts and disturbed shared decision making during their treatment occurring to a very different extent. Sociodemographic factors and the individual perception of pandemic-related problems likely determine this decisional dilemma for patients and can characterize vulnerable groups with special susceptibility for decisional problems and related consequences. (2) Methods: Cross-sectional data from the OnCoVID questionnaire study were used involving 540 patients from 11 participating institutions covering all major regions in Germany. Participants were actively involved in clinical treatment in oncology or psychiatry during the COVID-19 pandemic. Questionnaires covered five decision dimensions (conflicts and uncertainty, resources, risk perception, perception of consequences for clinical processes, perception of consequences for patients) and very basic demographic data (age, gender, stage of treatment and educational background). Decision uncertainties and distress were operationalized using equidistant five-point scales. Data analysis was performed using descriptive and various multivariate approaches. (3) Results: A total of 11.5% of all patients described intensive uncertainty in their clinical decisions that was significantly correlated with anxiety, depression, loneliness and stress. Younger and female patients and those of higher educational status and treatment stage had the highest values for these stressors (p < 0.001). Only 15.3% of the patients (14.9% oncology, 16.2% psychiatry; p = 0.021) considered the additional risk of COVID-19 infections as very important for their disease-related decisions. Regression analysis identified determinants for patients at risk of a decisional dilemma, including information availability, educational level, age group and requirement of treatment decision making. (4) Conclusions: In patients, the COVID-19 pandemic induced specific decisional uncertainty and distress accompanied by intensified stress and psychological disturbances. Determinants of specific vulnerability were related to female sex, younger age, education level, disease stages and perception of pandemic-related treatment modifications, whereas availability of sufficient pandemic-related information prevented these problems. The most important decisional criteria for patients under these conditions were expected side effects/complications and treatment responses. [ABSTRACT FROM AUTHOR]

Objective: The aim of this prospective pilot study is to establish an initial database to register patients diagnosed with different types of childhood glaucoma and the set-up of a national registry for childhood glaucoma (ReCG) in Germany. 28 children with different types of diagnosed childhood glaucoma, who were admitted and treated at the Childhood Glaucoma Center of the University Medical Center Mainz, Germany were included. Main outcome measures were the type of childhood glaucoma, mean intraocular pressure (IOP) and genetic data of the patients. Results: The documents and questionnaires for each individual included: informed consent form of the parents, medical history form of the child, patient's gestational history questionnaire and general anesthesia examination form. Primary congenital and secondary childhood glaucoma were revealed in 11 (39%) and 17 (61%) patients, respectively. The mean IOP measured with Perkins tonometer in all patients under general anesthesia at the time of inclusion was 17.5 ± 11.8 mmHg in the right and 17 ± 8.9 mmHg in the left eyes. In 33% of children with glaucoma mutations in the CYP1B1, FOXC1, LTBP2 and TEK genes were found. The development of specific questionnaires for childhood glaucoma provides detailed baseline data to establish a ReCG in Germany for the first time. [ABSTRACT FROM AUTHOR]

Background: Lifting The Burden (LTB) and European Headache Federation (EHF) have developed a set of headache service quality indicators, successfully tested in specialist headache centres. Their intended application includes all levels of care. Here we assess their implementation in primary care. Methods: We included 28 primary-care clinics in Germany (4), Turkey (4), Latvia (5) and Portugal (15). To implement the indicators, we interviewed 111 doctors, 92 nurses and medical assistants, 70 secretaries, 27 service managers and 493 patients, using the questionnaires developed by LTB and EHF. In addition, we evaluated 675 patients' records. Enquiries were in nine domains: diagnosis, individualized management, referral pathways, patient education and reassurance, convenience and comfort, patient satisfaction, equity and efficiency of headache care, outcome assessment and safety. Results: The principal finding was that Implementation proved feasible and practical in primary care. In the process, we identified significant quality deficits. Almost everywhere, histories of headache, especially temporal profiles, were captured and/or assessed inaccurately. A substantial proportion (20%) of patients received non-specific ICD codes such as R51 ("headache") rather than specific headache diagnoses. Headache-related disability and quality of life were not part of routine clinical enquiry. Headache diaries and calendars were not in use. Waiting times were long (e.g., about 60 min in Germany). Nevertheless, most patients (> 85%) expressed satisfaction with their care. Almost all the participating clinics provided equitable and easy access to treatment, and follow-up for most headache patients, without unnecessary barriers. Conclusions: The study demonstrated that headache service quality indicators can be used in primary care, proving both practical and fit for purpose. It also uncovered quality deficits leading to suboptimal treatment, often due to a lack of knowledge among the general practitioners. There were failures of process also. These findings signal the need for additional training in headache diagnosis and management in primary care, where most headache patients are necessarily treated. More generally, they underline the importance of headache service quality evaluation in primary care, not only to identify-quality failings but also to guide improvements. This study also demonstrated that patients' satisfaction is not, on its own, a good indicator of service quality. [ABSTRACT FROM AUTHOR]

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

Background: The German Committee on Vaccination recommends pneumococcal vaccination for infants, seniors 60+ years and patients at risk with defined underlying diseases. Aim of this study was to assess the pneumococcal vaccination rate (pnc-VR) in patients with certain incident inherited or acquired immunodeficiency or immunosuppression and to understand who vaccinates these patients who are particularly at high risk to develop a pneumococcal infection. Methods: We conducted a cohort study in patients aged 2 years or older, with a first episode of a “high-risk” condition between January 2013 and December 2014 based on a representative sample of German claims data. Pnc-VR was calculated as the proportion of patients receiving any pneumococcal vaccine within two years after first episode of “high-risk” condition. Further analyses cover pnc-VR stratified by high risk conditions and region, time to vaccination, and physician specialty administering the pneumococcal vaccination. Results: The study population comprised 204,088 incident “high-risk” patients (56% female). The overall pnc-VR within two years was 4.4% (95%-confidence interval: 4.3%-4.5%). Within specific high-risk conditions, we found the highest vaccination rate of 11.5% (10.1%-13.0%) among patients starting immunosuppressants with underlying rheumatoid arthritis followed by 9.9% (7.8%-12.4%) in HIV patients. Stratification by region revealed a slightly higher vaccination rate in Eastern (6.5%: 6.0%-6.9%) compared to Western Germany (4.2%: 4.1–4.3%). Median time to vaccination within the first two years in vaccinated patients was 332.5 days (Q1 142 days, Q3 528 days). The majority of patients (92.6%) got vaccinated by a general practitioner. Conclusion: Although these vulnerable patients need protection most, our study suggests that the overall pnc-VR after a first episode of a high-risk condition for pneumococcal disease is very low and vaccination is far too late. To prevent pneumococcal disease in patients at high risk, further efforts are needed to increase awareness and improve the timeliness of pneumococcal vaccination. [ABSTRACT FROM AUTHOR]

Background: Caring for patients with advanced lung cancer is of high relevance in different clinical settings. Lung cancer is among the most common causes of death from malignant neoplasms worldwide; with increasing prevalence and mortality. Aim: To get a better understanding of individual patients’ needs, exploring the experiences and meaning of living with advanced lung cancer at the end of life, and to develop strategies for improving patient-centred care in Germany. Design: Qualitative explorative interview study with patients, using grounded theory. Setting/Participants: A sample of 17 adults living with advanced lung cancer in Lower Saxony/Germany was recruited in two university hospitals. Patients were asked to tell of their experiences of living with advanced lung cancer. The emphasis of this study was the period of palliative tumour therapy. Results: The main phenomenon of living with advanced lung cancer is the feeling of having to redefine one’s own existence, such as social roles within and outside the family. The diagnosis trigger powerlessness, which can lead to information passivity, followed by acceptance of aggressive tumour treatment. Patients perceive a high degree of psychological and social stress, without being able to express this. There is a lack of regular appropriate psychosocial care accompanying chemotherapy. Patients ascribe their physical suffering to the side effects of tumour treatment, which may trigger a desire to die. Finally, patients tend to hide their individual needs, even when asked. Conclusions: Regarding the patients’ needs, greater emphasis must be placed on psychosocial care as part of the biopsychosocial model to adequately consider the patients’ concerns. Assessments can be helpful to enhance communication at an early stage across all professions into the multi-professional therapy. [ABSTRACT FROM AUTHOR]

Objectives: To explore effects of disease prevalence adjustment on ambulatory care-sensitive hospitalization (ACSH) rates used for quality comparisons.Data Sources/study Setting: County-level hospital administrative data on adults discharged from German hospitals in 2011 and prevalence estimates based on administrative ambulatory diagnosis data were used.Study Design: A retrospective cross-sectional study using in- and outpatient secondary data was performed.Data Collection: Hospitalization data for hypertension, diabetes, heart failure, chronic obstructive pulmonary disease, and asthma were obtained from the German Diagnosis Related Groups (DRG) database. Prevalence estimates were obtained from the German Central Research Institute of Ambulatory Health Care.Principal Findings: Crude hospitalization rates varied substantially across counties (coefficients of variation [CV] 28-37 percent across conditions); this variation was reduced by prevalence adjustment (CV 21-28 percent). Prevalence explained 40-50 percent of the observed variation (r = 0.65-0.70) in ACSH rates for all conditions except asthma (r = 0.07). Between 30 percent and 38 percent of areas moved into or outside condition-specific control limits with prevalence adjustment.Conclusions: Unadjusted ACSH rates should be used with caution for high-stakes public reporting as differences in prevalence may have a marked impact. Prevalence adjustment should be considered in models analyzing ACSH. [ABSTRACT FROM AUTHOR]

Objective: To examine the causal effect of a hospital's experience with treating hip fractures (volume) on patient treatment outcomes.Data Sources: We use a full sample of administrative data from German hospitals for 2007. The data provide detailed information on patients and hospitals. We also reference the hospitals' addresses and the zip codes of patients' place of residence.Study Design: We apply an instrumental variable approach to address endogeneity concerns due to reverse causality and unobserved patient heterogeneity. As instruments for case volume, we use the number of potential patients and number of other hospitals in the region surrounding each hospital.Principal Findings: Our results indicate that after applying an instrumental variables (IV) regression of volume on outcome, volume significantly increases quality.Conclusions: We provide evidence for the practice-makes-perfect hypothesis by showing that volume is a driving factor for quality. [ABSTRACT FROM AUTHOR]

Background: Quality of care public reporting provides structural, process and outcome information to facilitate hospital choice and strengthen quality competition. Yet, evidence indicates that patients rarely use this information in their decision-making, due to limited awareness of the data and complex and conflicting information. While there is enthusiasm among policy makers for public reporting, clinicians and researchers doubt its overall impact. Almost no study has analyzed how users behave on public reporting portals, which information they seek out and when they abort their search.Methods: This study employs web-usage mining techniques on server log data of 17 million user actions from Germany's premier provider transparency portal Weisse-Liste.de (WL.de) between 2012 and 2015. Postal code and ICD search requests facilitate identification of geographical and treatment area usage patterns. User clustering helps to identify user types based on parameters like session length, referrer and page topic visited. First-level markov chains illustrate common click paths and premature exits.Results: In 2015, the WL.de Hospital Search portal had 2,750 daily users, with 25% mobile traffic, a bounce rate of 38% and 48% of users examining hospital quality information. From 2013 to 2015, user traffic grew at 38% annually. On average users spent 7 min on the portal, with 7.4 clicks and 54 s between clicks. Users request information for many oncologic and orthopedic conditions, for which no process or outcome quality indicators are available. Ten distinct user types, with particular usage patterns and interests, are identified. In particular, the different types of professional and non-professional users need to be addressed differently to avoid high premature exit rates at several key steps in the information search and view process. Of all users, 37% enter hospital information correctly upon entry, while 47% require support in their hospital search.Conclusions: Several onsite and offsite improvement options are identified. Public reporting needs to be directed at the interests of its users, with more outcome quality information for oncology and orthopedics. Customized reporting can cater to the different needs and skill levels of professional and non-professional users. Search engine optimization and hospital quality advocacy can increase website traffic. [ABSTRACT FROM AUTHOR]

Copyright of Milbank Quarterly is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Increasing numbers of emergency calls, shortages of Emergency Medical Service (EMS), physicians, prolonged emergency response times and regionally different quality of treatment by EMS physicians require improvement of this system. Telemedical solutions have been shown to be beneficial in different emergency projects, focused on specific disease patterns. Our previous pilot studies have shown that the implementation of a holistic prehospital EMS teleconsultation system, between paramedics and experienced tele-EMS physicians, is safe and feasible in different emergency situations. We aim to extend the clinical indications for this teleconsultation system. We hypothesize that the use of a tele-EMS physician is noninferior regarding the occurrence of system-induced patient adverse events and superior regarding secondary outcome parameters, such as the quality of guideline-conforming treatment and documentation, when compared to conventional EMS-physician treatment.Methods/design: Three thousand and ten patients will be included in this single-center, open-label, randomized controlled, noninferiority trial with two parallel arms. According to the inclusion criteria, all emergency cases involving adult patients who require EMS-physician treatment, excluding life-threatening cases, will be randomly assigned by the EMS dispatching center into two groups. One thousand five hundred and five patients in the control group will be treated by a conventional EMS physician on scene, and 1505 patients in the intervention group will be treated by paramedics who are concurrently instructed by the tele-EMS physicians at the teleconsultation center. The primary outcome measure will include the rate of treatment-specific adverse events in relation to the kind of EMS physician used. The secondary outcome measures will record the specific treatment-associated quality indicators.Discussion: The evidence underlines the better quality of service using telemedicine networks between medical personnel and medical experts in prehospital emergency care, as well as in other medical areas. The worldwide unique EMS teleconsultation system in Aachen has been optimized and evaluated in pilot studies and subsequently integrated into routine use for a broad spectrum of indications. It has enabled prompt, safe and efficient patient treatment with optimized use of the "resource" EMS physician. There is, however, a lack of evidence as to whether the advantages of the teleconsultation system can be replicated in wider-ranging EMS-physician indications (excluding life-threatening emergency calls).Trial Registration: ClinicalTrials.gov, identifier: NCT02617875 . Registered on 24 November 2015. [ABSTRACT FROM AUTHOR]

Background: The number of catheter related bloodstream infections (CRBSI) could be reduced and the outcome improved if specific standards in the quality of care were maintained. Therefore, the development of quality assurance (QA) procedures was commissioned to be included in the national mandatory QA programme in Germany.Methods: Indicators representing quality deficiencies and potential for improvement of quality in relation to prevention and management of central venous catheters (CVC) were developed by (1) evidence-based literature searches and the compiling of an indicator register; (2) a multi-professional expert panel including patient representatives who selected indicators from this register by using a modified RAND/UCLA Appropriateness Method; (3) defining methods for data assessment, risk adjustment and feedback of indicator results to service providers; and (4) consulting all relevant medical societies and other stakeholders with regard to the QA procedures that had been developed.Results: Thirty-two indicators for CRBSI prevention and management were eventually approved by the expert panel. These indicators represent quality of care at predefined points with regard to indication, insertion and care of CVCs, management of sepsis, general hygiene and training of health care personnel. Fourteen indicators represent processes, together with 7 representing structures and 11 outcomes. For assessing these indicators, data was obtained from four sources: claims data from health insurance funds, routine claims data from hospital electronic information systems, case specific longitudinal documentation from service providers and cross-sectional annual assessment of structures.Conclusions: It was possible to develop indicators for mandatory QA procedures on CRBSI that take into account the different perspectives of all stakeholders involved. Despite efforts to use routine data for documentation wherever possible, most indicators required extra documentation. [ABSTRACT FROM AUTHOR]

Background: Even though physician rating websites (PRWs) have been gaining in importance in both practice and research, little evidence is available on the association of patients' online ratings with the quality of care of physicians. It thus remains unclear whether patients should rely on these ratings when selecting a physician. The objective of this study was to measure the association between online ratings and structural and quality of care measures for 65 physician practices from the German Integrated Health Care Network "Quality and Efficiency" (QuE).Methods: Online reviews from two German PRWs were included which covered a three-year period (2011 to 2013) and included 1179 and 991 ratings, respectively. Information for 65 QuE practices was obtained for the year 2012 and included 21 measures related to structural information (N = 6), process quality (N = 10), intermediate outcomes (N = 2), patient satisfaction (N = 1), and costs (N = 2). The Spearman rank coefficient of correlation was applied to measure the association between ratings and practice-related information.Results: Patient satisfaction results from offline surveys and the patients per doctor ratio in a practice were shown to be significantly associated with online ratings on both PRWs. For one PRW, additional significant associations could be shown between online ratings and cost-related measures for medication, preventative examinations, and one diabetes type 2-related intermediate outcome measure. There again, results from the second PRW showed significant associations with the age of the physicians and the number of patients per practice, four process-related quality measures for diabetes type 2 and asthma, and one cost-related measure for medication.Conclusions: Several significant associations were found which varied between the PRWs. Patients interested in the satisfaction of other patients with a physician might select a physician on the basis of online ratings. Even though our results indicate associations with some diabetes and asthma measures, but not with coronary heart disease measures, there is still insufficient evidence to draw strong conclusions. The limited number of practices in our study may have weakened our findings. [ABSTRACT FROM AUTHOR]

Background: Targeted and stringent measures of tuberculosis prevention are necessary to achieve the goal of tuberculosis elimination in countries of low tuberculosis incidence. Methods: We ascertained the knowledge about tuberculosis risk factors and stringency of tuberculosis prevention measures by a standardized questionnaire among physicians in Germany involved in the care of individuals from classical risk groups for tuberculosis. Results: 510 physicians responded to the online survey. Among 16 risk factors immunosuppressive therapy, HIV-infection and treatment with TNF-antagonist were thought to be the most important risk factors for the development of tuberculosis in Germany. Exposure to a patient with tuberculosis ranked on the 10th position. In the event of a positive tuberculin-skin-test or interferon-γ release assay only 50%, 40%, 36% and 25% of physicians found that preventive chemotherapy was indicated for individuals undergoing tumor necrosis factor-antagonist therapy, close contacts of tuberculosis patients, HIV-infected individuals and migrants, respectively. Conclusions: A remarkably low proportion of individuals with latent infection with Mycobacterium tuberculosis belonging to classical risk groups for tuberculosis are considered candidates for preventive chemotherapy in Germany. Better knowledge about the risk for tuberculosis in different groups and more stringent and targeted preventive interventions will probably be necessary to achieve tuberculosis elimination in Germany. [ABSTRACT FROM AUTHOR]

Background: In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy. Methods: Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented. Results: In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs) work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP) training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1) problem analysis, and definition of (2) structural prerequisites and (3) procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs), templates, checklists and other supporting materials for researchers. Conclusion: All in all, our problem analyses revealed that a substantial number of barriers contribute to the low implementation of clinical research in German general practice. Some issues are deeply rooted in Germany's market-based healthcare and academic systems and traditions. However, new developments may facilitate change: recent developments in the German research landscape are encouraging. [ABSTRACT FROM AUTHOR]

The article presents a study which confirmed the efficacy and safety of 6-monthly depot formulation of leuprolide acetate in daily clinical practice in Germany. It has been showed and confirmed in this study that the reliable reduction of PSA and testosterone levels which have been demonstrated in previous clinical studies of twice-yearly leuprolide acetate can also be achieved in routine clinical practice.

Within the framework of item response theory (IRT), we developed a German version of an item bank, as well as a software application that can be employed to measure anxiety by means of a computer adaptive test (CAT). A sample of n = 2348 psychiatric and psychosomatic patients answered a set of up to 13 standardized questionnaires. 81 items drawn from these questionnaires were considered pertinent to the anxiety construct. Various tests were conducted to ensure the suitability of these items for an IRT-based assessment. After these tests, 50 items remained in the item bank and were calibrated using the Generalized Partial Credit Model. Simulation studies conducted on an independent sample of n = 1528 respondents indicate that 6–8 items suffice to measure the latent trait with high precision (standard error ≤ 0.32). CAT scores correlated highly with scores estimated from all available items ( r = .97) and scale scores of the State Trait Anxiety Inventory (STAI, state scale, r = .93). Within a routine clinical setting, 102 in-patients answered the Anxiety-CAT along with a number of established anxiety questionnaires. The correlation between the Anxiety-CAT and the STAI state scale was still high ( r = .60), but lower than the correlations found in the simulation studies. The Anxiety-CAT was able to differentiate between mental health disorders in a similar manner as established questionnaires. These results suggest that the Anxiety-CAT does indeed exhibit the advantages expected from theory, but the results of further studies are needed in order to judge its full potential for research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: In German breast cancer care, the S1-guidelines of the 1990s were substituted by national S3-guidelines in 2003. The application of guidelines became mandatory for certified breast cancer centers. The aim of the study was to assess guideline adherence according to time intervals and its impact on survival.Methods: Women with primary breast cancer treated in three rural hospitals of one German geographical district were included. A cohort study design encompassed women from 1996-97 (N = 389) and from 2003-04 (N = 488). Quality indicators were defined along inpatient therapy sequences for each time interval and distinguished as guideline-adherent and guideline-divergent medical decisions. Based on all of the quality indicators, a binary overall adherence index was defined and served as a group indicator in multivariate Cox-regression models. A corrected group analysis estimated adjusted 5-year survival curves.Results: From a total of 877 patients, 743 (85 %) and 504 (58 %) were included to assess 104 developed quality indicators and the resuming binary overall adherence index. The latter significantly increased from 13-15 % (1996-97) up to 33-35 % (2003-04). Within each time interval, no significant survival differences of guideline-adherent and -divergent treated patients were detected. Across time intervals and within the group of guideline-adherent treated patients only, survival increased but did not significantly differ between time intervals. Across time intervals and within the group of guideline-divergent treated patients only, survival increased and significantly differed between time intervals.Conclusions: Infrastructural efforts contributed to the increase of process quality of the examined certified breast cancer center. Paradoxically, a systematic impact on 5-year survival has been observed for patients treated divergently from the guideline recommendations. This is an indicator for the appropriate application of guidelines. A maximization of guideline-based decisions instead of the ubiquitous demand of guideline adherence maximization is advocated. [ABSTRACT FROM AUTHOR]