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Introduction: The U.S. Army medics are often the first responders in the care of sick and injured soldiers on the battlefield, sick call in a Role 2 aid station and garrison clinics. Sick call medics are required to utilize the Algorithm Directed Troop Medical Care (ADTMC) to care for and then render a disposition for these soldiers. The current ADTMC manual is a thick, heavy paper manual. A desktop and smartphone application has been developed that contains the entire ADTMC manual algorithm-based content. Our goal is to enhance the medics' clinical learning and critical thinking skills while improving their evaluation, disposition, and documentation during patient encounters.Materials and Methods: The application was field-tested with the 173rd IBCT (A) while attending a field exercise at Grafenwoehr, Germany. At the unit's Role 2 tent setup, the use of the paper manual to the utilization of the same material via the ADTMC application was compared by observing the medics' workflows directly while they were caring for ill and injured soldiers.Results: Medics, while examining patients, would demonstrate 50% faster exam time using the application compared to medics using only the manual. Moreover, a 50% decrease in document processing time as a result of digitization of the paper documentation process was confirmed. The application ("app") enabled the medics to continue their screening assessments and patient disposition duties on a desktop computer or a smartphone without the need to refer to the paper manual.Conclusion: Medics, by adopting this tool, will become quicker, more efficient, and develop critical thinking skills. In other words, the ability to objectively evaluate patients in order to form a proper disposition of sick and injured soldiers during training, in the field, as well as in garrison. When utilized properly, the ADTMC application ensures that soldiers reporting to sick call are expeditiously routed to the appropriate level of care, and is a vehicle for further training for medics in the care of soldiers. [ABSTRACT FROM AUTHOR]

Objective: The goal of the present paper is to provide evidence on the behavior of physician practice cost functions.Data Sources: Our study is based on the data of 3686 physician practices in Germany for the years 2006 to 2008.Study Design: We apply a translog functional form and include a comprehensive set of variables that have not been previously used in this context. A system of four equations using three-stage least squares is estimated.Principal Findings: We find that a higher degree of specialization leads to a decrease in costs, whereas quality certification increases costs. Costs of group practices are higher than of solo practices. The latter finding can be explained by the existence of indivisibilities of expensive technical equipment. Smaller practices do not reach the critical mass to invest in certain technologies, which leads to differences in the type of health care services provided by different practice types.Conclusions: This is the first study to use physician practices as the unit of observation and to consider the endogenous character of physician input. Our results suggest that identifying factors that influence physician practice costs is important for providing evidence-based physician payment systems and to enable decision-makers to set incentives effectively. [ABSTRACT FROM AUTHOR]

The continued growth in the economic evaluation of healthcare over the past 25 years has led to a shortage of trained health economists globally, leading to a number of universities and/or national governments developing specialised health economics programmes to train more health economists. One of the common problems with many of these training programmes is that they only educate new health economists to the Masters level, and as such they are unable to cover the many skills needed by a successful health economist. Furthermore, government and industry interests have ensured that economic evaluation is a heavily regulated environment that gives little incentive to seek further education. These two related factors (under-education and over-regulation) have lead to a situation where economic evaluation methods may adversely limit innovation of therapeutics and devices in clinical areas that perform badly when evaluated on the cost per QALY scale. The good news, however, is that the tide is turning and theoretically sound adjustments (such as risk adjustments and stated preferences) to the current paradigm are now being considered. This, of cause, is just the tip of the iceberg with other important issues such as time preference and the endogeneity of preference remaining very much under-researched areas in health. This paper concludes that many of these real-world issues, such as patient preferences, can be avoided by using artificial objective functions such as cost per QALY, but this comes at the cost of irrelevance and the misallocation of resources. If we are to meet all of the future challenges in economic evaluation in healthcare then we must focus more on advanced education and far less on the regulation of health economists. [ABSTRACT FROM AUTHOR]

This paper examines the paper of Haux et al. in this issue of this journal. It gives some background on specifics of the German health care system, which underlie the theses and prognoses proposed by Haux et al. In analogy to a forecast of the future of health informatics, which is now 10 years old, I then suggest that these attempts meet two types of challenges:•that of overestimating the positive effects of recent advances, which later are found not to scale up; and•that of blind spots with respect to unforeseen significant advances.The attempt to find indications of such in the projections of Haux et al. leads, among other, to the conclusion that the projections of direct linkages between patients and care providers may be overoptimistic. As to wheather the deviating opinions matter in the end, it is concluded that the technology advances may require less attention that the restructuring of the health care system required to take advantage of the advances of technology. [Copyright &y& Elsevier]

This paper investigates the mechanisms behind the health effects of retirement. Using a Regression Discontinuity Design to exploit financial incentives in the German pension system for identification, I find that retirement improves subjective health status and mental health, while also reducing outpatient care utilization. I explore a wide range of health behaviors, time use, and effect heterogeneity as potential mechanisms. Relief from work-related stress and strain, increased sleep duration as well as more frequent physical exercise seem to be key mechanisms through which retirement affects health. [ABSTRACT FROM AUTHOR]

Background: In 2015 and 2018, European Society of Cardiology guidelines for percutaneous coronary intervention (PCI) favoring radial access over femoral access were published. These recommendations were based on randomized trials suggesting that patients treated radially experienced reduced bleeding complications and all-cause mortality. We aimed to assess acceptance and results of radial access in a real-world scenario by analyzing all PCI cases in the Quality Assurance in Invasive Cardiology (QuIK) registry.Methods: The QuIK registry prospectively collects data on all diagnostic and interventional coronary procedures from 148 private practice cardiology centers in Germany. Major adverse cardiac and cerebrovascular events (MACE) were defined as myocardial infarction, stroke, or death during hospitalization.Results: From 2012 to 2018, 189,917 patients underwent PCI via either access method. The rate of radial approach steadily increased from 13 to 49%. The groups did not differ significantly with respect to age or extent of coronary disease. Femoral approach was significantly more common in patients with ST elevation myocardial infarction and cardiogenic shock. Overall, there were significant differences in MACE (radial 0.12%; femoral 0.24%; p < 0.0009) and access site complications (radial 0.2%; femoral 0.8% (p < 0.0009).Conclusion: Our data reveals an increase in use of radial access in recent years in Germany. The radial approach emerged as favorable regarding MACE in non-myocardial infarction patients, as well as favorable regarding access site complication regardless of indication for percutaneous intervention. [ABSTRACT FROM AUTHOR]

Objectives: Health-care information systems are particularly security-critical. In order to make these applications secure, the security analysis has to be an integral part of the system design and IT management process for such systems.Methods: This work presents the experiences and results from the security analysis of the system architecture of the German Health Card, by making use of an approach to model-based security engineering that is based on the UML extension UMLsec. The focus lies on the security mechanisms and security policies of the smart-card-based architecture which were analyzed using the UMLsec method and tools.Results: Main results of the paper include a report on the employment of the UMLsec method in an industrial health information systems context as well as indications of its benefits and limitations. In particular, two potential security weaknesses were detected and countermeasures discussed.Conclusions: The results indicate that it can be feasible to apply a model-based security analysis using UMLsec to an industrial health information system like the German Health Card architecture, and that doing so can have concrete benefits (such as discovering potential weaknesses, and an increased confidence that no further vulnerabilities of the kind that were considered are present). [ABSTRACT FROM AUTHOR]

Objectives: In the field of open electronic health records (EHRs), openEHR as an archetype-based approach is being increasingly recognised. It is the objective of this paper to shortly describe this approach, and to analyse how openEHR archetypes impact on health professionals and semantic interoperability.Methods: Analysis of current approaches to EHR systems, terminology and standards developments. In addition to literature reviews, we organised face-to-face and additional telephone interviews and tele-conferences with members of relevant organisations and committees.Results: The openEHR archetypes approach enables syntactic interoperability and semantic interpretability -- both important prerequisites for semantic interoperability. Archetypes enable the formal definition of clinical content by clinicians. To enable comprehensive semantic interoperability, the development and maintenance of archetypes needs to be coordinated internationally and across health professions. Domain knowledge governance comprises a set of processes that enable the creation, development, organisation, sharing, dissemination, use and continuous maintenance of archetypes. It needs to be supported by information technology.Conclusions: To enable EHRs, semantic interoperability is essential. The openEHR archetypes approach enables syntactic interoperability and semantic interpretability. However, without coordinated archetype development and maintenance, 'rank growth' of archetypes would jeopardize semantic interoperability. We therefore believe that openEHR archetypes and domain knowledge governance together create the knowledge environment required to adopt EHRs. [ABSTRACT FROM AUTHOR]

Objectives: GTDS is a documentation system used by more than 40 German hospital cancer registries. This paper discusses the factors that contributed to its success concerning design, development, and routine use.Methods: Success is measured in terms of the system's financial independence of public grants and its successful use by the registries. Success factors are presented in a descriptive way covering the topics of development (tools and development team) as well as system's functionality and user support. The description of the system's use and user satisfaction was collected in a user survey conducted in 1999.Results: GTDS has become the main tool in hospital cancer registries in Germany and remarkably contributed to their success. A comprehensive data network between hospital cancer registries and population-based cancer registries has especially been established in the new states. After the first years of routine use the registries produce valuable data analyses on the basis of common tools. Under specific conditions physicians use the system directly for treatment management. The system succeeded to be financed by support contracts for continuous development which indicates generally good user acceptance. Close interaction between users and developers is important to meet user requirements during development and maintenance.Conclusion: Important success factors are the strong ministry's support including initial sponsoring and introduction of support contracts, the comprehensive functionality as well as flexibility and broad user support which allow the adaptation to different environments. [ABSTRACT FROM AUTHOR]

Objectives: The introduction of information system components (ISCs) usually leads to a change in existing processes, e.g. processes of patient care. These processes might become even more complex and variable than before. An early participation of end users and a better understanding of human factors during design and introduction of ISCs are key factors for a successful introduction of ISCs in health care. Nonetheless no specialized methods have been developed until now to systematically support the integration of ISCs in existing processes of patient care while taking into account these requirements. In this paper, therefore, we introduce a procedure model to implement Concepts for Smooth Integration of ISCs (CSI-ISC).Methods: Established theories from economics and social sciences have been applied in our model, among them the stress-strain-concept, the contrastive task analysis (KABA), and the phase model for the management of information systems.Results: CSI-ISC is based on the fact that while introducing new information system components, users experience additional workload. One essential aim during the introduction process therefore should be to systematically identify, prioritize and ameliorate workloads that are being imposed on human beings by information technology in health care. To support this, CSI-ISC consists of a static part (workload framework) and a dynamic part (guideline for the introduction of information system components into existing processes of patient care).Conclusions: The application of CSI-ISC offers the potential to minimize additional workload caused by information system components systematically. CSI-ISC rationalizes decisions and supports the integration of the information system component into existing processes of patient care. [ABSTRACT FROM AUTHOR]

Objectives: Our objectives were to analyze and assess data formats for their suitability for conclusive and secure long-term archiving and to develop a concept for legally secure transformation of electronically signed documents that are not available in data formats appropriate for long-term archiving.Methods: On the basis of literature review and Internet searches we developed general evaluation criteria to assess data formats with regard to their suitability for conclusive and secure long-term archiving. The assessment of data formats refers to format specifications and available literature. For the analyses of the transformation of signed documents we analyzed legal requirements on the basis of laws and ordinances as well as technical requirements by means of literature reviews, Internet searches and technical specifications.Results: The following evaluation criteria are suited for this kind of assessment of data formats: transparency and standardization, stability, presentation and security. According to our assessment the following data formats are most suitable for conclusive and secure long-term archiving: PDF for formatted and unstructured text documents, XML for markup languages, TIFF for images in general, DICOM for medical images and S/MIME for the storage of e-mail. To transform electronically signed documents we propose an elementary procedure and universal basic model in form of an XML schema definition that includes the necessary legal and technical information.Conclusions: If electronic documents are to replace paper-based documents in patient records, they have to conform to the criteria for secure long-term archiving. The analyzed data formats are to be extended by mechanisms to guarantee the long-term security of electronic signatures. To transform large quantities of documents in a legally secure way, our basic model has to be extended for automated procedures. [ABSTRACT FROM AUTHOR]

Background: In an effort to contain the effects of the coronavirus disease (COVID-19) pandemic, health care systems worldwide implemented telemedical solutions to overcome staffing, technical, and infrastructural limitations. In Germany, a multitude of telemedical systems are already being used, while new approaches are rapidly being developed in response to the crisis. However, the extent of the current implementation within different health care settings, the user's acceptance and perception, as well as the hindering technical and regulatory obstacles remain unclear.Objective: The aim of this paper is to assess the current status quo of the availability and routine use of telemedical solutions, user acceptance, and the subjectively perceived burdens on telemedical approaches. Furthermore, we seek to assess the perception of public information quality among professional groups and their preferred communication channels.Methods: A national online survey was conducted on 14 consecutive days in March and April 2020, and distributed to doctors, nurses, and other medical professionals in the German language.Results: A total of 2827 medical professionals participated in the study. Doctors accounted for 65.6% (n=1855) of the professionals, 29.5% (n=833) were nursing staff, and 4.9% (n=139) were identified as others such as therapeutic staff. A majority of participants rated the significance of telemedicine within the crisis as high (1065/2730, 39%) or neutral (n=720, 26.4%); however, there were significant differences between doctors and nurses (P=.01) as well as between the stationary sector compared to the ambulatory sector (P<.001). Telemedicine was already in routine use for 19.6% (532/2711) of German health care providers and in partial use for 40.2% (n=1090). Participants working in private practices (239/594, 40.2%) or private clinics (23/59, 39.0%) experienced less regulatory or technical obstacles compared to university hospitals (586/1190, 49.2%). A majority of doctors rated the public information quality on COVID-19 as good (942/1855, 50.8%) or very good (213/1855, 11.5%); nurses rated the quality of public information significantly lower (P<.001). Participant's age negatively correlated with the perception of telemedicine's significance (ρ=-0.23; P<.001).Conclusions: Telemedicine has a broad acceptance among German medical professionals. However, to establish telemedical structures within routine care, technical and regulatory burdens must be overcome. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the humanistic burden on caregivers of patients with advanced non-small cell lung cancer (aNSCLC) as the disease progresses.Methods: Data were drawn from a cross-sectional study of patients with aNSCLC and their caregivers conducted in France, Germany, and Italy between 2015 and 2016. Data were collected by medical chart review and patient and caregiver questionnaires. The EuroQol five-dimension three-level (EQ-5D-3L) was used to evaluate patient and caregiver health status. Caregivers also completed the Work Productivity and Activity Impairment (WPAI) questionnaire and Zarit Burden Interview (ZBI).Results: The population for the analysis consisted of 427 caregivers (mean age 53.5 years; 72.6% female; 54.9% spouse; 36.2% in full-time employment) and 427 matched patients (mean age 66.2 years; 68.6% male). Most (69.5%) patients were receiving first-line therapy for advanced disease. Patients' caregivers provided a mean of 29.5 h of support per week. Significant differences in EQ-5D-3L scores were observed between caregivers of patients receiving first and later lines of therapy in France (0.87 vs. 0.78; p = 0.0055). Among employed caregivers, overall work impairment was considerable and ranged from 21.1% in Germany to 30.4% in France and 29.7% in Italy. Caregivers of patients receiving later lines of therapy in France rated their own health status as significantly worse than did those caring for patients receiving first-line therapy (82.7 vs. 72.9; p = 0.0039).Conclusions: Informal caregivers provided the majority of support for patients with advanced NSCLC and their caregiving activities impose a significant humanistic burden. [ABSTRACT FROM AUTHOR]

Background: Key recommendations for the management of patients with polypharmacy are structured medication counselling (SMC), medication lists and systematic medication reviews.Objective: The aim of this study was to identify determinants (hindering and facilitating factors) for the implementation of the recommendations in general practice.Methods: This study was linked to a tailored intervention aimed at improving the implementation of the recommendations in German general practice. Interviews and focus groups with different healthcare professionals were carried out in the design phase and after delivery of the intervention. The material from both data collections was analysed separately in a content analytical approach resulting in two sets of categories. For this study, the subcategories of both sets were assigned to the Tailoring Interventions for Chronic Diseases (TICD) checklist, a comprehensive framework of determinants of practice.Results: Interviews with 24 general practitioners (GPs), 4 other medical specialists, 1 pharmacist, 3 nurses and 6 medical assistants as well as 2 mixed focus groups with 17 professionals were conducted. We identified 93 determinants: 29 referred to medication counselling, 21 to the use of medication lists, 20 to medications reviews and 23 to all recommendations. The determinants were related to all 7 main domains and to 25 of the 57 subdomains on the TICD checklist including guideline factors, patient factors, individual healthcare professional factors, social, political and legal factors, incentives and resources, and capacity for organizational change.Conclusion: While many interventions to improve polypharmacy focus on the provision of pharmacological knowledge, a much wider range of domains need to be addressed, such as communication skills, patient involvement and practice organization. [ABSTRACT FROM AUTHOR]

Objective: Little attention has been given to psychological factors as correlates of health care use, which could be an important key to manage it. We analyzed the association of psychological factors with health care use.Data Sources: Primary data were obtained from three follow-ups (2002, 2008, and 2011) of a large population-based study with participants aged 40+.Study Design: Using a longitudinal observational study, we analyzed the psychological factors of negative and positive affect (affective well-being), life satisfaction (cognitive well-being), self-efficacy, loneliness, self-esteem, optimism, and flexible goal adjustment using fixed-effects regressions.Data Collection: The participants provided data on health care use (visits to general practitioners [GPs] and specialists as well as hospitalization) and psychological factors via self-administered questionnaires and personal interviews (7,116 observations). The sample was drawn using national probability sampling.Principal Findings: Controlling for self-rated health, chronic diseases and sociodemographics, increases in affective well-being, and optimism decreased health care use of GPs, specialists, and hospital treatment. Increases in cognitive well-being decreased health care use of GPs and specialists. Increases in self-efficacy decreased hospitalization.Conclusions: The study underlines the influence of psychological factors on health care use. Thus, whenever possible, future studies of health care use should include psychological factors, and efforts to reduce health care use might focus on such factors. [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: Evaluating the potential of the high-dimensional propensity score (HDPS) to control for residual confounding in studies analyzing quality of care based on administrative health insurance data.Data Source: Secondary data from 2004 to 2009 from three German statutory health insurance providers.Study Design: We conducted a retrospective cohort study in patients with elective percutaneous coronary interventions (PCIs) and compared the mortality risk between the in- and outpatient setting using Cox regression. Adjustment for predefined confounders was performed using conventional propensity score (PS) techniques. Further, an HDPS was calculated based on predefined and empirically selected confounders from the database.Principal Findings: Conventional PS methods showed a decreased mortality risk for outpatient compared to inpatient PCIs, while trimming of patients with nonoverlap in the HDPS distribution and weighting resulted in a comparable risk. Most comorbidities were less prevalent in the HDPS-trimmed population compared to the original one.Conclusion: The HDPS methodology may reduce residual confounding by rendering the studied cohort more comparable through restriction. However, results cannot be generalized for the entire study population. To provide unbiased results, full assessment of all unmeasured confounders from proxy information in the database would be necessary. [ABSTRACT FROM AUTHOR]

Background: Asthma patients are enrolled in multimodal pulmonary rehabilitation (PR) programs. However, available data for the effectiveness of PR in asthma are sparse. Therefore, the primary aim of this randomized control trial (RCT) is to evaluate short-term (end of rehabilitation) and intermediate-term effectiveness (3 months after rehabilitation) of PR for patients with asthma regarding asthma control (primary outcome) and other outcomes. Secondly, moderator effects of gender, age, baseline asthma control, quality of life, and anxiety will be examined. Thirdly, a longitudinal follow-up study will explore the course of the outcomes over one year and the annual costs.Methods: The EPRA study is a single-center randomized controlled waiting-list trial in the Bad Reichenhall Clinic. Inclusion criteria include a referral diagnosis for uncontrolled asthma, no cognitive impairment and no very severe co-morbidities that indicate significantly greater illness morbidity than asthma alone. In the intervention group (IG), participants will start PR within 4 weeks after randomization; participants of the control group (CG) will start PR 20 weeks after randomization. Data will be assessed at randomization (T0), after 4 weeks (T1; IG: begin of PR), 7 weeks (T2; IG: end of PR), and 20 weeks (T3, CG: begin of PR). The primary outcome is asthma control at T2/T3. Secondary outcomes are health-related quality of life, functional exercise capacity, dyspnea, anxiety, depression, subjective self-management skills, illness perceptions, sick leave and subjective work ability. Outcomes will be analyzed with analysis of covariance, including baseline values of the respective outcomes as covariates. Healthcare costs will be analyzed with a gamma model with a log-link. A longitudinal follow-up study will generate additional data at 3/6/9/12 months after PR for both IG and CG. Latent change models will be used to analyze the course of the primary and secondary outcomes. Annual cost differences before and after rehabilitation will be compared by paired t-test.Discussion: This RCT will determine the effectiveness of a complex inpatient PR for asthma patients concerning asthma control. Furthermore, important medical and economic information regarding the effectiveness of PR as part of the long-term management of patients with uncontrolled asthma will be generated.Trial Registration: German Clinical Trials Register ( DRKS00007740 , May 15, 2015). Protocol version: 1.0 (December, 23, 2016). [ABSTRACT FROM AUTHOR]

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: Multimorbid patients receiving polypharmacy represent a growing population at high risk for negative health outcomes. Tailoring is an approach of systematic intervention development taking account of previously identified determinants of practice. The aim of this study was to assess the effect of a tailored program to improve the implementation of three important processes of care for this patient group: (a) structured medication counseling including brown bag reviews, (b) the use of medication lists, and (c) structured medication reviews to reduce potentially inappropriate medication.Methods: We conducted a cluster-randomized controlled trial with a follow-up time of 9 months. Participants were general practitioners (GPs) organized in quality circles and participating in a GP-centered care contract of a German health insurance. Patients aged >50 years, suffering from at least 3 chronic diseases, receiving more than 4 drugs, and being at high risk for medication-related events according to the assessment of the treating GP were enrolled. The tailored program consisted of a workshop for GPs and health care assistants, educational materials and reminders for patients, and the elaboration of implementation action plans. The primary outcome was the change in the degree of implementation between baseline and follow-up, measured by a summary score of 10 indicators. The indicators were based on structured surveys with patients and GPs.Results: We analyzed the data of 21 GPs (10 - intervention group, 11 - control group) and 273 patients (130 - intervention group, 143 - control group). The increase in the degree of implementation was 4.2 percentage points (95% confidence interval: -0.3, 8.6) higher in the intervention group compared to the control group (p = 0.1). Two of the 10 indicators were significantly improved in the intervention group: medication counseling (p = 0.017) and brown bag review (p = 0.012). Secondary outcomes showed an effect on patients' self-reported use of medication lists when buying drugs in the pharmacy (p = 0.03).Conclusions: The tailored program may improve implementation of medication counseling and brown bag review whereas the use of medication lists and medication reviews did not improve. No effect of the tailored program on the combined primary outcome could be substantiated. Due to limitations of the study, results have to be interpreted carefully. The factors facilitating and hindering successful implementation will be examined in a comprehensive process evaluation.Trial Registration Number: ISRCTN34664024 , assigned 14/08/2013. [ABSTRACT FROM AUTHOR]

Background: Women's participation in medicine and the need for gender equality in healthcare are increasingly recognised, yet little attention is paid to leadership and management positions in large publicly funded academic health centres. This study illustrates such a need, taking the case of four large European centres: Charité - Universitätsmedizin Berlin (Germany), Karolinska Institutet (Sweden), Medizinische Universität Wien (Austria), and Oxford Academic Health Science Centre (United Kingdom).Case: The percentage of female medical students and doctors in all four countries is now well within the 40-60% gender balance zone. Women are less well represented among specialists and remain significantly under-represented among senior doctors and full professors. All four centres have made progress in closing the gender leadership gap on boards and other top-level decision-making bodies, but a gender leadership gap remains relevant. The level of achieved gender balance varies significantly between the centres and largely mirrors country-specific welfare state models, with more equal gender relations in Sweden than in the other countries. Notably, there are also similar trends across countries and centres: gender inequality is stronger within academic enterprises than within hospital enterprises and stronger in middle management than at the top level. These novel findings reveal fissures in the 'glass ceiling' effects at top-level management, while the barriers for women shift to middle-level management and remain strong in academic positions. The uneven shifts in the leadership gap are highly relevant and have policy implications.Conclusion: Setting gender balance objectives exclusively for top-level decision-making bodies may not effectively promote a wider goal of gender equality. Academic health centres should pay greater attention to gender equality as an issue of organisational performance and good leadership at all levels of management, with particular attention to academic enterprises and newly created management structures. Developing comprehensive gender-sensitive health workforce monitoring systems and comparing progress across academic health centres in Europe could help to identify the gender leadership gap and utilise health human resources more effectively. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is a leading cause of death in Europe. In Germany, a declining mortality rate from acute myocardial infarction (AMI) has been observed in the last decades. Nevertheless, there are large differences between the federal states when looking at the mortality and morbidity of AMI. Saxony-Anhalt is one of the federal states with the highest mortality rates for AMI in Germany. In 2012, the regional myocardial infarction registry of Saxony-Anhalt (RHESA) was established to investigate the individual, infrastructural, and health care factors with respect to an urban (city of Halle) and rural (region of Altmark) population. For detailed observation the RHESA-CARE study was conducted in 2014. RHESA-CARE focuses on the symptoms during infarction, the behaviour of patients while alerting for infarction, the use of rehabilitation possibilities, and long-term care.Methods/design: RHESA-CARE is an extended baseline survey of AMI patients registered in RHESA who are aged 25 or more, and inhabitants of the city of Halle (Saale) or the district of Altmark in the federal state of Saxony-Anhalt, Germany. Detailed information was collected on classical and psychosocial cardiovascular risk factors as well as factors of alerting behaviour, first aid, and utilization of medical and rehabilitation services. High data quality is ensured by a detailed system of quality control.Discussion: RHESA-CARE has the main objective to investigate factors that influence morbidity and mortality rates due to AMI. Another purpose is the comparison of a rural and urban patient population. It provides an opportunity to serve as a base for improvement of patients' behaviour and health care as well as further research. [ABSTRACT FROM AUTHOR]

Purpose: Osteoarthritis (OA) has been shown to be associated with decreased physical function, which may impact upon a person's self-rated health (SRH). Only a few studies have examined the association between OA and SRH in the general population, but to date none have used a clinical definition of OA. The objectives are: (1) To examine the cross-sectional association between clinical OA and fair-to-poor SRH in the general population; (2) To examine whether this association differs between countries; (3) To examine whether physical function is a mediator in the association between clinical OA and SRH.Methods: Baseline data of the European Project on OSteoArthritis (EPOSA) were used, which includes pre-harmonized data from six European cohort studies (n = 2709). Clinical OA was defined according to the American College of Rheumatology criteria. SRH was assessed using one question: How is your health in general? Physical function was assessed using the Western Ontario and McMaster Universities OA Index and Australian/Canadian OA Hand Index.Results: The prevalence of fair-to-poor SRH ranged from 19.8 % in the United Kingdom to 63.5 % in Italy. Although country differences in the strength of the associations were observed, clinical OA of the hip, knee and hand were significantly associated with fair-to-poor SRH in five out of six European countries. In most countries and at most sites, the association between clinical OA and fair-to-poor SRH was partly or fully mediated by physical function.Conclusions: Clinical OA at different sites was related to fair-to-poor SRH in the general population. Most associations were (partly) mediated by physical functioning, indicating that deteriorating physical function in patients with OA should be a point of attention in patient care. [ABSTRACT FROM AUTHOR]

Background: Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort.Methods/design: Our plan is to randomize critically ill patients with acute kidney injury to 'early' or 'late' initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome.Discussion: Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury.Trial Registration: German Clinical Trials Register: DRKS00004367 ( www.germanctr.de ); 28 May 2013. [ABSTRACT FROM AUTHOR]

Background: Managing therapy-related side-effects and improving health-related quality of life in patients with colorectal cancer is still challenging. The need for an effective management of adverse events and unmet supportive care needs have been widely discussed. In the past decade, interventions by nursing staff gained more and more importance. Evidence suggests that a majority of patients even in early stages of the disease experience substantial impairments potentially resulting in diminished therapy adherence as well as impaired quality of life. However, evidence for the effectiveness of nurse-led interventions on symptom management and quality of life is still very limited. This especially applies to care transitions between different inpatient and outpatient health care providers throughout the course of treatment and aftercare.Methods/design: Supportive Cancer Care Networkers (SCAN) is a prospective randomized controlled trial conducted in eight large and middle-sized German cancer centers and municipal hospitals. The target population is adults with colorectal cancer UICC I-III after initial R-0 resection scheduled for adjuvant chemotherapy or guideline-based aftercare only. 370 patients will be randomly assigned to either intervention or control group. Patients in the intervention group will receive an additional support by specialized oncology nurses for eight weeks after discharge from hospital by telephone, consisting of symptom monitoring, counselling on self-assessment and self-management and dealing with individual resources for coping and psychosocial well-being. The primary endpoint will be health-related quality of life (HRQoL) at eight weeks after discharge from the initial treating hospital.Discussion: The presented SCAN trial is to provide information that will be useful to advance our understanding of complex interdependencies between symptom severity, supportive care needs, functioning and the risk for diminished HRQoL. Most importantly, these patient-reported outcomes are not fully implemented in today's clinical routine practice potentially resulting in therapy cessations and lower chemotherapy treatment rates for colorectal cancer especially in older patients.Trial Registration: ClinicalTrials.gov Identifier NCT01651832. [ABSTRACT FROM AUTHOR]

Planning for future care needs is likely to be influenced by both policy and culture. We compared attitudes regarding the usefulness of planning ahead for future care needs, processes of preparation for these needs (becoming aware of the risk of future care needs, gathering information about available options, deciding on preferences, concrete planning), and outcomes of preparation (e.g., knowledge about services) in 294 East German, 288 West German, and 590 American seniors. American respondents had higher preparation scores. Compared to the size of national differences, differences between East and West German seniors were generally smaller. East Germans made fewer decisions on preferences and engaged in less concrete planning. Most of the national and regional differences in preparation for future care needs were reduced or eliminated by controlling for differences in the perceived usefulness of planning. [ABSTRACT FROM AUTHOR]

Background: A system of dementia-specific case conferences (WELCOME-IdA) was evaluated using a stepped-wedge design in six nursing homes (NHs) to enable nursing staff to analyse properly the behavioural and psychological symptoms (BPSD) of residents with dementia. A process evaluation of the context, the recruitment and target populations reached (residents and nursing staff) and the delivery of the intervention and implementation strategy was carried out to explore the lack of effectiveness of WELCOME-IdA on the residents' prevalence of BPSD.Methods: This study was part of a larger process evaluation using a mixed-methods design. Standardised questionnaires, semi-structured interviews, attendance lists, standardised protocols and written self-reports were used to collect the data. The quantitative data were analysed by calculating descriptive statistics. The qualitative interviews were analysed using deductive content analysis and the self-reports were analysed using a documentary analysis.Results: None of the NHs had prior experience with dementia-specific case conferences on a specific concept related to BPSD. The number of residents for whom a dementia-specific case conference was held was lower than expected. The number of nursing staff reached was high, although as defined in the study protocol, core nursing teams continuously participating in all components of the intervention were not established throughout the study. An analysis of the delivery of the intervention showed a reduction in the frequency of dementia-specific case conferences and deviations in the process structure and role structure of WELCOME-IdA. The strategy used to facilitate the implementation of WELCOME-IdA was mostly followed. An analysis of the recruitment of residents indicated that the variation in which residents were included in the study sample was high and that the intended sample size required to achieve a power >80% was not reached.Conclusion: An analysis of the process evaluation data indicated that there were inaccuracies in the implementation of WELCOME-IdA and there were methodological limitations within the design of the effectiveness trial, both of which could explain the lack of effectiveness of WELCOME-IdA. To optimise the process structure of WELCOME-IdA, an assessment of BPSD and a pre-selection of possible domains for the behavioural analysis could be conducted prior to a dementia-specific case conference.Trial Registration: ISRCTN20203855 . Registered on 10 July 2013. [ABSTRACT FROM AUTHOR]

Background: In accordance the WHO framework of health system functions and by using the indicators collected within the EURO-HEALTHY project, this work aims to contribute to the discussion on the classification of EU health systems.Methods: Three methods were used in this article: factor analysis, cluster analysis and descriptive analysis; data were mainly collected from the WHO and Eurostat databases.Results: The most relevant result is the proposed classification of health systems into the following clusters: Austria-Germany, Central and Northern Countries, Southern Countries, Eastern Countries 'A' and Eastern Countries 'B'.Conclusions: The proposed typology contributes to the discussion about how to classify health systems; the typology of EU health systems allows comparisons of characteristics and health system performance across clusters and policy assessment and policy recommendation within each cluster. [ABSTRACT FROM AUTHOR]