Ambulatory screening and decontamination to prevent Staphylococcus aureus complications in patients undergoing elective surgery (STAUfrei): study protocol for a controlled intervention study.

BACKGROUND: Surgical site infections (SSI) are the most common health care associated infections in German acute hospitals and can result in prolonged hospital stays, increased use of antibiotics and utilisation of care. Staphylococcus aureus bacteria (methicillin-resistant S Aureus (MRSA) and methicillin-susceptible S Aureus (MSSA)) are amongst the most prominent causes of SSI. While up to 90% of documented S Aureus colonization is already detectable prior to hospital admission, the majority of hygiene measures in Germany is focused on the hospital setting. It is hypothesized that early detection and decontamination of S Aureus colonization in primary care can prevent health care associated infections and reduce the number of S Aureus isolates in the hospital setting. METHODS: This study is a controlled interventional study (N = 13,260) with a pre-post comparison. The intersectoral intervention (over 2 years) will encompass the following elements: ambulatory detection and decontamination of MRSA and MSSA prior to elective surgery combined with a structured follow-up care. Patients from the control group will be screened in the hospital setting, in accordance with the standard operating procedure (SOP) in routine care. The primary endpoint is the reduction of MRSA and MSSA colonization upon hospital admission. Secondary endpoints are complication rate (SSI), length of stay, recolonization of patients (3 and 6 months after release), patient and provider satisfaction, patient compliance and cost development. DISCUSSION: In case of positive results, the chance of a widespread uptake and implementation in routine care are considered high. The active involvement of primary care providers in the implementation of screening and decontamination as well as follow-up care is a unique feature of this study. The positive resonance of primary care providers during the recruitment phase highlights the relevance of the topic to the participating actors. These efforts are coupled with patient education and specifically trained medical staff, promising a sustained impact. The STAUfrei care pathway can homogenize current practices in routine care and provide a template for further intersectoral cooperation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00016615. Registered on April 1st, 2019.

Correction to: Healthcare professionals' perspectives on working conditions, leadership, and safety climate: a cross-sectional study.

In the original publication of this article [1], the authors missed that reverse coding was necessary for the item "Do you work separate from your colleagues?" before calculating the scale 'social relations'. So they corrected the analysis accordingly. The results with the revised scale show that there are no longer any significant differences between nurses and physicians with regard to this scale.

Healthcare professionals' perspectives on working conditions, leadership, and safety climate: a cross-sectional study.

BACKGROUND: Promoting patient and occupational safety are two key challenges for hospitals. When aiming to improve these two outcomes synergistically, psychosocial working conditions, leadership by hospital management and supervisors, and perceptions of patient and occupational safety climate have to be considered. Recent studies have shown that these key topics are interrelated and form a critical foundation for promoting patient and occupational safety in hospitals. So far, these topics have mainly been studied independently from each other. The present study investigated hospital staffs' perceptions of four different topics: (1) psychosocial working conditions, (2) leadership, (3) patient safety climate, and (4) occupational safety climate. We present results from a survey in two German university hospitals aiming to detect differences between nurses and physicians. METHODS: We performed a cross-sectional study using a standardized paper-based questionnaire. The survey was conducted with nurses and physicians to assess the four topics. The instruments mainly consisted of scales of the German version of the COPSOQ (Copenhagen Psychosocial Questionnaire), one scale of the Copenhagen Burnout Inventory (CBI), scales to assess leadership and transformational leadership, scales to assess patient safety climate using the Hospital Survey on Patient Safety Culture (HSPSC), and analogous items to assess occupational safety climate. RESULTS: A total of 995 completed questionnaires out of 2512 distributed questionnaires were returned anonymously. The overall response rate was 39.6%. The sample consisted of 381 physicians and 567 nurses. We found various differences with regard to the four topics. In most of the COPSOQ and the HSPSC-scales, physicians rated psychosocial working conditions and patient safety climate more positively than nurses. With regard to occupational safety, nurses indicated higher occupational risks than physicians. CONCLUSIONS: The WorkSafeMed study combined the assessment of the four topics psychosocial working conditions, leadership, patient safety climate, and occupational safety climate in hospitals. Looking at the four topics provides an overview of where improvements in hospitals may be needed for nurses and physicians. Based on these results, improvements in working conditions, patient safety climate, and occupational safety climate are required for health care professionals in German university hospitals - especially for nurses.

Pharmaceutical policies: effects of financial incentives for prescribers.

BACKGROUND: The proportion of total healthcare expenditures spent on drugs has continued to grow in countries of all income categories. Policy-makers are under pressure to control pharmaceutical expenditures without adversely affecting quality of care. Financial incentives seeking to influence prescribers' behaviour include budgetary arrangements at primary care and hospital settings (pharmaceutical budget caps or targets), financial rewards for target behaviours or outcomes (pay for performance interventions) and reduced benefit margin for prescribers based on medicine sales and prescriptions (pharmaceutical reimbursement rate reduction policies). This is the first update of the original version of this review. OBJECTIVES: To determine the effects of pharmaceutical policies using financial incentives to influence prescribers' practices on drug use, healthcare utilisation, health outcomes and costs (expenditures). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (searched 29/01/2015); MEDLINE, Ovid SP (searched 29/01/2015); EMBASE, Ovid SP (searched 29/01/2015); International Network for Rational Use of Drugs (INRUD) Bibliography (searched 29/01/2015); National Health Service (NHS) Economic Evaluation Database (searched 29/01/2015); EconLit - ProQuest (searched 02/02/2015); and Science Citation Index and Social Sciences Citation Index, Institute for Scientific Information (ISI) Web of Knowledge (citation search for included studies searched 10/02/2015). We screened the reference lists of relevant reports and contacted study authors and organisations to identify additional studies. SELECTION CRITERIA: We included policies that intend to affect prescribing by means of financial incentives for prescribers. Included in this category are pharmaceutical budget caps or targets, pay for performance and drug reimbursement rate reductions and other financial policies, if they were specifically targeted at prescribing or drug utilisation. Policies in this review were defined as laws, rules, regulations and financial and administrative orders made or implemented by payers such as national or local governments, non-government organisations, private or social insurers and insurance-like organisations. One of the following outcomes had to be reported: drug use, healthcare utilisation, health outcomes or costs. The study had to be a randomised or non-randomised trial, an interrupted time series (ITS) analysis, a repeated measures study or a controlled before-after (CBA) study. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility for inclusion of studies and risks of bias using Cochrane Effective Practice and Organisation of Care (EPOC) criteria and extracted data from the included studies. For CBA studies, we reported relative effects (e.g. adjusted relative change). The review team re-analysed all ITS results. When possible, the review team also re-analysed CBA data as ITS data. MAIN RESULTS: Eighteen evaluations (six new studies) of pharmaceutical policies from six high-income countries met our inclusion criteria. Fourteen studies evaluated pharmaceutical budget policies in the UK (nine studies), two in Germany and Ireland and one each in Sweden and Taiwan. Three studies assessed pay for performance policies in the UK (two) and the Netherlands (one). One study from Taiwan assessed a reimbursement rate reduction policy. ITS analyses had some limitations. All CBA studies had serious limitations. No study from low-income or middle-income countries met the inclusion criteria.Pharmaceutical budgets may lead to a modest reduction in drug use (median relative change -2.8%; low-certainty evidence). We are uncertain of the effects of the policy on drug costs or healthcare utilisation, as the certainty of such evidence has been assessed as very low. Effects of this policy on health outcomes were not reported. Effects of pay for performance policies on drug use and health outcomes are uncertain, as the certainty of such evidence has been assessed as very low. Effects of this policy on drug costs and healthcare utilisation have not been measured. Effects of the reimbursement rate reduction policy on drug use and drug costs are uncertain, as the certainty of such evidence has been assessed as very low. No included study assessed the effects of this policy on healthcare utilisation or health outcomes. Administration costs of the policies were not reported in any of the included studies. AUTHORS' CONCLUSIONS: Although financial incentives are considered an important element in strategies to change prescribing patterns, limited evidence of their effects can be found. Effects of policies, including pay for performance policies, in improving quality of care and health outcomes remain uncertain. Because pharmaceutical policies have uncertain effects, and because they might cause harm as well as benefit, proper evaluation of these policies is needed. Future studies should consider the impact of these policies on health outcomes, drug use and overall healthcare expenditures, as well as on drug expenditures.

The Contribution of Intersectoral Healthcare Centres with an Extended Outpatient Care Model to Improve Regional Care-Structures-A Qualitative Study.

Many smaller hospitals in Germany are currently threatened with closure due to economic reasons and politically derived centralization. In some-especially rural areas-this may result in a lack of accessible local care structures. At the same time, patients are unnecessarily admitted to hospitals due to insufficient primary care structures and healthcare coordination. Intersectoral health centers (IHC), as new intermediary structures, may offer round-the-clock monitoring (Extended Outpatient Care, EOC), with fewer infrastructure needs than hospitals and, thus, could offer a sustainable solution. In an iterative process, 30 expert interviews (with physicians, nurses and other healthcare experts) formed the basis for the derivation of diagnostic groups, relevant related patient characteristics and scenarios, as well as structural preconditions necessary for safe care in the setting of the new model of IHC/EOC. Additionally, three workshops within the multidisciplinary research team (including healthcare services researchers, GPs, and health economists) were performed. Inductive categories on disease-, case-, sociodemographic- and infrastructure-related criteria were derived following thematic analysis. Due to the expert interviews, general practice equipment plus continuous monitoring beds should form the basic infrastructure for EOCs, which should be adjusted to local needs and infrastructure demands. GPs could be aided through (electronic) support by other specialists. IHC, as a physician-led facility, should rely on experienced nurses to allow for 24-h services and to support integrated team-based primary care with GPs. Alongside nurses, case managers, therapists and social workers can be included in the structure, allowing for improved integration of (primary) care services. In order to sustain low-threshold, local access to care, especially in rural areas, IHC with extended monitoring and integration of coordinative support, emerged as a promising solution that could solve many common patient needs without the need for hospital-based inpatient care.

Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.

OBJECTIVE: The ALBINO Trial (NCT03162653) investigates effects of very early postnatal allopurinol on neurocognitive outcome following perinatal asphyxia where prenatal informed consent (IC) is impossible. Ethically and legally, waiver of consent and/or deferred consent (DC) is acceptable in such an emergency. Short oral/two-step consent (SOC, brief information and oral consent followed by IC) has recently been investigated. METHODS: Mixed-methods analysis of parental opinions on DC versus SOC in the context of neonatal asphyxia in a survey at two German centres. Prospective parents (ProP), parents of healthy newborns (PNeo) and parents of asphyxiated infants (PAx) born between 2006 and 2016 were invited. RESULTS: 108 of 422 parents participated (ProP:43; PNeo:35; PAx:30). Most parents trusted physicians, wanted preinterventional information and agreed that in emergencies interventions should begin immediately. Intergroup and intragroup variability existed for questions about DC and SOC. In the ALBINO Trial situation, 55% preferred SOC, and 26% reported DC without information might adversely affect their trust. Only 3% reported to potentially take legal action after DC. PAx were significantly more likely to support DC. PAx more frequently expressed positive emotions and appreciation for neonatal research. In open-ended questions, parents gave many constructive recommendations. CONCLUSION: In this survey, parents expressed diverse opinions on consent, but the majority preferred SOC over DC. Parents who had experienced emergency admission of their asphyxiated neonates were more trusting. Obtaining parental perspectives is essential when designing studies, while being cognisant that these groups of parents may not represent the opinion of all parents.

A post-Flexner comparative case study of medical training responses to health system needs in Brazil and Germany.

Health systems need medical professionals who can and will work in outpatient settings, such as general practitioner practices or health centres. However, medical students complete only a small portion of their medical training there. Furthermore, this type of training is sometimes seen as inferior to training in academic medical centres and university hospitals. Hence, the healthcare system's demand and the execution of medical curricula do not match. Robust concepts for better alignment of both these parts are lacking. This study aims to (1) describe decentral learning environments in the context of traditional medical curricula and (2) derive ideas for implementing such scenarios further in existing curricula in response to particular medicosocietal needs.This study is designed as qualitative cross-national comparative education research. It comprises three steps: first, two author teams consisting of course managers from Brazil and Germany write a report on change management efforts in their respective faculty. Both teams then compare and comment on the other's report. Emerging similarities and discrepancies are categorised. Third, a cross-national analysis is conducted on the category system.Stakeholders of medical education (medical students, teaching faculty, teachers in decentral learning environments) have differing standards, ideals and goals that are influenced by their own socialisation-prominently, Flexner's view of university hospital training as optimal training. We reiterate that both central and decentral learning environments provide meaningful complementary learning opportunities. Medical students must be prepared to navigate social aspects of learning and accept responsibility for communities. They are uniquely positioned to serve as visionaries and university ambassadors to communities. As such, they can bridge the gap between university hospitals and decentral learning environments.

Patient Input in Regional Healthcare Planning-A Meaningful Contribution.

Background: There are well-known methodological and analytical challenges in planning regional healthcare services (HCS). Increasingly, the need for data-derived planning, including user-perspectives, is discussed. This study aims to better understand the possible contribution of citizen experience in the assessment of regional HCS needs in two regions of Germany. Methods: We conducted a written survey in two regions of differing size-a community (3653 inhabitants) and a county (165,211 inhabitants). Multinomial logistic regression was used to assess the impact of sociodemographic and regional factors on the assessment of HCS provided by general practitioners (GPs) and specialists. Results: Except for age and financial resources available for one's own health, populations did not differ significantly between the regions. However, citizens' perception of HCS (measured by satisfaction with 1 = very good to 5 = very poor) differed clearly between different services (e.g., specialists: 3.8-4.3 and pharmacies: 1.7-2.5) as well as between regions (GPs: 1.7-3.1; therapists: 2.9-4). In the multivariate model, region (next to income and age) was a consistent predictor of the perception of GP- and specialist-provided care. Discussion: Citizens' perceptions of HCS correspond to regional provider density (the greater the density, the better the perception) and add insights into citizens' needs. Therefore, they can provide valuable information on regional HCS strengths and weaknesses and are a valid resource to support decision makers in shaping regional care structures.

Do perceived working conditions and patient safety culture correlate with objective workload and patient outcomes: A cross-sectional explorative study from a German university hospital.

BACKGROUND: Workload and demands on hospital staff have been growing over recent years. To ensure patient and occupational safety, hospitals increasingly survey staff about perceived working conditions and safety culture. At the same time, routine data are used to manage resources and performance. This study aims to understand the relation between survey-derived measures of how staff perceive their work-related stress and strain and patient safety on the one hand, and routine data measures of workload and quality of care (patient safety) on the other. METHODS: We administered a written questionnaire to all physicians and nurses in the inpatient units at a German university hospital. The questionnaire was an amalgam of the Copenhagen Psychosocial Questionnaire (COPSOQ), the Copenhagen Burnout Inventory (CBI) scale to assess patient-related burnout of and portions of the Hospital Survey on Patient Safety Culture (HSPSC). Indicators from administrative data used to assess workload and patient-related work-strain were: amount of overtime worked, work intensity recording of nurses, cost weight, occupancy rate and DRG-related length of stay. Quality of care was assessed using readmission rates and disease-related length of stay. Univariate associations were tested with Pearson correlations. RESULTS: Response rate were 37% (224) for physicians and 39% (351) for nurses. Physicians' overtime correlated strongly with perceived quantitative demands (.706, 95% CI: 0.634 to 0.766), emotional demands (.765; 95% CI: 0.705 to 0.814), and perceived role conflicts (.655, 95% CI: 0.573 to 0.724). Nurses' work-intensity measures were associated with decreasing physician job satisfaction and with less favorable perceptions of the appropriateness of staffing (-.527, 95% CI:-0.856 to 0.107). Both professional groups showed medium to strong associations between the morbidity measure (cost weight) and role conflicts; between occupancy rates and role clarity (-.482, 95% CI: -0.782 to -0.02) and predictability of work (-.62, 95% CI: -0.848 to -0.199); and between length of stay and internal team functioning (-.555, 95% CI: -0.818 to -0.101). Higher readmission rates were associated with lower perceived patient safety (-.476, 95% CI: -0.779 to 0.006), inadequate staffing (-.702, 95% CI: -0.884 to -0.334), and worse team functioning (-.520, 95% CI: -0.801 to -0.052). Shorter disease-related length of stay was associated with better teamwork within units (-.555, 95% CI: -0.818 to -0.101) and a lower risk of physician burnout (-.588, 95% CI: -0.846 to -0.108). CONCLUSION: Perceptions of hospital personnel regarding sub-optimal workplace safety and teamwork issues correlated with worse patient outcome measures. Furthermore, objective measures of overtime work as well as objective measures of workload correlated clearly with subjective work-related stress and strain. This suggests that objective workload measures (such as overtime worked) could be used to indirectly monitor job-related psychosocial strain on employees and, thus, improve not only staff wellbeing but also patient outcomes. On the other hand, listening to their personnel could help hospitals to improve patient (and employee) safety.

Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults-study protocol for a stepped-wedge cluster randomized trial (PAWEL Study).

BACKGROUND: Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients' age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective. METHODS: The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures). DISCUSSION: Results of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013311 . Registered on 10 November 2017.

Do Occupational and Patient Safety Culture in Hospitals Share Predictors in the Field of Psychosocial Working Conditions? Findings from a Cross-Sectional Study in German University Hospitals.

BACKGROUND: In the healthcare sector, a comprehensive safety culture includes both patient care-related and occupational aspects. In recent years, healthcare studies have demonstrated diverse relationships between aspects of psychosocial working conditions, occupational, and patient safety culture. The aim of this study was to consider and test relevant predictors for staff's perceptions of occupational and patient safety cultures in hospitals and whether there are shared predictors. From two German university hospitals, 381 physicians and 567 nurses completed a questionnaire on psychosocial working conditions, occupational, and patient safety culture. Two regression models with predictors for occupational and patient safety culture were conceptually developed and empirically tested. In the Occupational Safety Culture model, job satisfaction (ß = 0.26, p ≤ 0.001), work‒privacy conflict (ß = -0.19, p ≤ 0.001), and patient-related burnout (ß = -0.20, p ≤ 0.001) were identified as central predictors. Important predictors in the Patient Safety Culture model were management support for patient safety (ß = 0.24, p ≤ 0.001), supervisor support for patient safety (ß = 0.18, p ≤ 0.001), and staffing (ß = 0.21, p ≤ 0.001). The two models mainly resulted in different predictors. However, job satisfaction and leadership seem to play an important role in both models and can be used in the development of a comprehensive management of occupational and patient safety culture.

The relevance of comorbidities for heart failure treatment in primary care: A European survey.

AIM: To assess the impact of comorbidities on chronic heart failure (CHF) therapy. METHODS: The IMPROVEMENT-HF survey included 11,062 patients from 100 primary care practices in 14 European countries. The influence of patient characteristics on drug regimes was assessed with multinomial logistical regression. RESULTS: Combined drug regimes were given to 48% of CHF patients, consisting of 2.2 drugs on average. Patient characteristics accounted for 35%, 42% and 10% of the variance in one-, two- and three-drug regimes, respectively. Myocardial infarction (MI), atrial fibrillation (AF), diabetes, hypertension, and lung disease influenced prescribing most. AF made all combinations containing beta-blockers more likely. Thus for single drug regimes, MI increased the likelihood for non-recommended beta-blocker monotherapy (OR 1.3; 95% CI 1.2-1.4), while for combination therapy recommended regimes were most likely. For both hypertension and diabetes, ACE-inhibitors were the most likely single drug, while the most likely second drugs were beta-blockers in hypertension and digoxin in diabetes. CONCLUSIONS: Patient characteristics have a clear impact on prescribing in European primary care. Up to 56% of drug regimes were rational taking patient characteristics into account. Situations of insufficient prescribing, such as patients post MI, need to be addressed specifically.

Management of heart failure in The Netherlands.

In The Netherlands, the incidence and prevalence of heart failure are rising as is the case in most other European countries. Overall, there are 200,000 patients with heart failure in The Netherlands and around 25,000 hospitalisations annually with a discharge diagnosis of heart failure. Most of these patients are managed in primary care, often together with a cardiologist. There is an active guideline program in different professional organisations (e.g. general practitioners, cardiologists) and in 2002 a collaborative multidisciplinary guideline for management of chronic heart failure was developed. However, there is clearly room for improvement in the adherence to these guidelines both with regard to the diagnosis and the treatment of HF patients. For example, ACE-I and beta-blockers are still under-prescribed. In particular, the more severely ill patients seem to be under treated. At present, general practitioners and cardiologists differ in their views on heart failure, resulting in differences in diagnosis and management. In addition to the multidisciplinary guidelines, several other initiatives have been developed to improve outcomes in these patients, such as rapid access clinics and outpatient heart failure clinics.

Heart failure guidelines and prescribing in primary care across Europe.

BACKGROUND: Major international differences in heart failure treatment have been repeatedly described, but the reasons for these differences remain unclear. National guideline recommendations might be a relevant factor. This study, therefore, explored variation of heart failure guideline recommendations in Europe. METHODS: Treatment recommendations of 14 national guidelines published after 1994 were analyzed in relation to the heart failure treatment guideline of the European Society of Cardiology. To test potential relations between recommendations and prescribing, national prescribing patterns as obtained by a European study in primary care (IMPROVEMENT-HF) were related to selected recommendations in those countries. RESULTS: Besides the 14 national guidelines used by primary care physicians in the countries contacted, the European guideline was used in four countries, and separate guidelines for specialists and primary care were available in another four countries. Two countries indicated that no guideline was used up to 2000. Comprehensiveness of the guidelines varied with respect to length, literature included and evidence ratings. Relevant differences in treatment recommendations were seen only in drug classes where evidence had changed recently (beta-blockers and spironolactone). The relation between recommendation and prescribing for selected recommendations was inconsistent among countries. CONCLUSION: Differences in guideline recommendations are not sufficient to explain variation of prescribing among countries, thus other factors must be considered.

Viagra: a success story for rationing?

The 1998 launch of Viagra prompted widespread fears about the budgetary consequences for insurers and governments, all the more so since Viagra was only the first of a new wave of so-called lifestyle drugs. The fears have turned out to be greatly exaggerated. This paper analyzes the rationing strategies adopted in four countries (United States, Britain, Germany, and Sweden), relates them to the characteristics of different types of health care systems, and identifies the conditions necessary for successful cost containment. The case of Viagra, it concludes, holds out two general lessons: first, allow exceptions to total bans on reimbursement; second, involve the medical profession in the decision-making process.