[Further Development of Maturity Levels of Quality and Risk Management System at the University Hospital Schleswig-Holstein]. / Weiterentwicklung der Reifegrade des Qualitäts ­ und Risikomanagementsystems am Universitätsklinikum Schleswig-Holstein.

INTRODUCTION: Following upon our publication "Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein" in 2018, we present the further development of the maturity model. Quality and risk management in hospitals is not only required by law but also plays a significant role in an optimized patient- and process-oriented health care. METHODS: A questionnaire-based self-assessment was carried out by 46 clinical units of the UKSH (location Kiel and Lübeck) for the analysis of nine quality criteria overall. Four of these criteria (quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM)) were already analysed in 2016 and were extended to the five new aspects, namely audits and on-site inspections, responsibilities, morbidity and mortality conferences, hygiene training and surgical safety checklist. Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). RESULTS: The comparison of the results for quality criteria QS, CIRS, BM, PM and the overall maturity level between 2016 and 2020 demonstrated statistically significant improvements in 2020 concerning the criteria QS (p=0.013), CIRS (p=0.026), PM (p=0.000) and the overall maturity levels (p=0.019). The criteria BM did not show any statistically significant improvement. The five newly added quality criteria demonstrated maturity levels "A" (fully implemented) and "B" (largely implemented) the following: audits and on-site inspections (100%), responsibilities (95.6%), morbidity and mortality conferences (65.2%), hygiene training (95.6%), and surgical safety checklist (100%). CONCLUSION: An integrated quality and risk management has already been a firm element of UKSH for years. Nevertheless, review of effectiveness of the initiated targeted measures is still a challenge. This is the reason why it is necessary to develop effective and resource-saving approaches for the evaluation of measures and the identification of potential for improvement. The recognised potential for improvement should be risk-prioritized and completely exploited using sustainable measures. Following this principle, we designed a qualitative model of maturity levels for the evaluation of our quality and risk management system at the UKSH in 2016, whose further development we demonstrate here.

A scattered landscape: assessment of the evidence base for 71 patient decision aids developed in a hospital setting.

BACKGROUND: Recent publications reveal shortcomings in evidence review and summarization methods for patient decision aids. In the large-scale "Share to Care (S2C)" Shared Decision Making (SDM) project at the University Hospital Kiel, Germany, one of 4 SDM interventions was to develop up to 80 decision aids for patients. Best available evidence on the treatments' impact on patient-relevant outcomes was systematically appraised to feed this information into the decision aids. Aims of this paper were to (1) describe how PtDAs are developed and how S2C evidence reviews for each PtDA are conducted, (2) appraise the quality of the best available evidence identified and (3) identify challenges associated with identified evidence. METHODS: The quality of the identified evidence was assessed based on GRADE quality criteria and categorized into high-, moderate-, low-, very low-quality evidence. Evidence appraisal was conducted across all outcomes assessed in an evidence review and for specific groups of outcomes, namely mortality, morbidity, quality of life, and treatment harms. Challenges in evidence interpretation and summarization resulting from the characteristics of decision aids and the type and quality of evidence are identified and discussed. RESULTS: Evidence reviews assessed on average 25 systematic reviews/guidelines/studies and took about 3 months to be completed. Despite rigorous review processes, nearly 70% of outcome-specific information derived for decision aids was based on low-quality and mostly on non-directly comparative evidence. Evidence on quality of life and harms was often not provided or not in sufficient form/detail. Challenges in evidence interpretation for use in decision aids resulted from, e.g., a lack of directly comparative evidence or the existence of very heterogeneous evidence for the diverse treatments being compared. CONCLUSIONS: Evidence reviews in this project were carefully conducted and summarized. However, the evidence identified for our decision aids was indeed a "scattered landscape" and often poor quality. Facing a high prevalence of low-quality, non-directly comparative evidence for treatment alternatives doesn't mean it is not necessary to choose an evidence-based approach to inform patients. While there is an urgent need for high quality comparative trials, best available evidence nevertheless has to be appraised and transparently communicated to patients.

Enhancing patient safety by integrating ethical dimensions to Critical Incident Reporting Systems.

BACKGROUND: Critical Incident Reporting Systems (CIRS) provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS. METHODS: A six-step approach combined the analysis of CIRS databases, potential cases, literature on clinical and organizational ethics, cases from ethics consultations, and experts' experience to construct a framework for CIRS cases with ethical relevance and map the categories with principles of biomedical ethics. RESULTS: Four main categories of critical incidents with ethical relevance were derived: (1) patient-related communication; (2) consent, autonomy, and patient interest; (3) conflicting economic and medical interests; (4) staff communication and corporate culture. Each category was refined with different subcategories and mapped with case examples and exemplary related ethical principles to demonstrate ethical relevance. CONCLUSION: The developed framework for CIRS cases with its ethical dimensions demonstrates the relevance of integrating ethics into the concept of risk-, quality-, and organizational management. It may also support clinical ethics consultations' presence and effectiveness. The proposed enhancement could contribute to hospitals' ethical infrastructure and may increase ethical behavior, patient safety, and employee satisfaction.

Dysregulated Expression of Antimicrobial Peptides in Skin Lesions of Patients with Cutaneous T-cell Lymphoma.

Mycosis fungoides and Sézary syndrome belong to the group of primary cutaneous T-cell lymphomas. Because of the inflammatory appearance of the skin lesions, we hypothesized that antimicrobial peptides might be dysregulated in these conditions, similar to in inflammatory skin conditions. Samples from 20 patients with cutaneous T-cell lymphoma were analysed using immunohistochemistry and enzyme-linked immunoassay (ELISA) of skin washing fluids of hBD-2, hBD-3, RNase 7 and psoriasin. Immunohistochemistry results were compared with previous analyses of healthy and psoriatic skin. ELISA and immunohistochemistry revealed a higher expression of psoriasin in lesional cutaneous T-cell lymphoma compared with non-lesional and healthy samples. Immunohistochemistry showed an increase in hBD-2 in lesional cutaneous T-cell lymphoma skin compared with healthy skin. The expression profile of antimicrobial peptides in cutaneous T-cell lymphoma appears to be dysregulated, indicating a potential role of antimicrobial peptides in cutaneous T-cell lymphoma. A larger prospective study and functional studies are needed to improve our understanding of the role of antimicrobial peptides in cutaneous T-cell lymphoma.

[Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein]. / Reifegrade des Qualitäts- und Risikomanagementsystems am Universitätsklinikum Schleswig-Holstein.

INTRODUCTION: Quality and risk management in hospitals are not only required by law but also for an optimal patient-centered and process-optimized patient care. To evaluate the maturity levels of quality and risk management at the University Hospital Schleswig-Holstein (UKSH), a structured analytical tool was developed for easy and efficient application. METHODS: Four criteria concerning quality management - quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM) - were evaluated with a structured questionnaire. Self-assessment and external assessment were performed to classify the maturity levels at the UKSH (location Kiel and Lübeck). Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). First of all, an external assessment was initiated by the head of the department of quality and risk management. Thereafter, a self-assessment was performed by 46 clinical units of the UKSH. Discrepancies were resolved in a collegial dialogue. Based on these data, overall maturity levels were obtained for every clinical unit. RESULTS: The overall maturity level "A" was reached by three out of 46 (6.5%) clinical units. No unit was graded with maturity level "D". 50% out of all units reached level "B" and 43.5% level "C". The distribution of the four different quality criteria revealed a good implementation of complaint management (maturity levels "A" and "B" in 78.3%), whereas the levels for CIRS were "C" and "D" in 73.9%. Quality assurance and process management showed quite similar distributions for the levels of maturity "B" and "C" (87% QS; 91% PM). DISCUSSION: The structured analytical tool revealed maturity levels of 46 clinical units of the UKSH and defined the maturity levels of four relevant quality criteria (QS, CIRS, BM, PM). As a consequence, extensive procedures were implemented to raise the standard of quality and risk management. In future, maturity levels will be reevaluated every two years. This qualitative maturity level model enables in a simple and efficient way precise statements concerning presence, manifestation and development of quality and risk management.

Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre-post trial.

OBJECTIVES: To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM). DESIGN: Pre-post study. SETTING: University Hospital Schleswig-Holstein (UKSH), Kiel Campus. PARTICIPANTS: Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH. INTERVENTIONS: The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate. MAIN OUTCOME MEASURES: In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICSPDM). Pre-post comparisons were done using t-tests. RESULTS: The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICSPDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects. CONCLUSIONS: The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care.

The Quality and Utility of Artificial Intelligence in Patient Care.

BACKGROUND: Artificial intelligence (AI) is increasingly being used in patient care. In the future, physicians will need to understand not only the basic functioning of AI applications, but also their quality, utility, and risks. METHODS: This article is based on a selective review of the literature on the principles, quality, limitations, and benefits AI applications in patient care, along with examples of individual applications. RESULTS: The number of AI applications in patient care is rising, with more than 500 approvals in the United States to date. Their quality and utility are based on a number of interdependent factors, including the real-life setting, the type and amount of data collected, the choice of variables used by the application, the algorithms used, and the goal and implementation of each application. Bias (which may be hidden) and errors can arise at all these levels. Any evaluation of the quality and utility of an AI application must, therefore, be conducted according to the scientific principles of evidence-based medicine-a requirement that is often hampered by a lack of transparency. CONCLUSION: AI has the potential to improve patient care while meeting the challenge of dealing with an ever-increasing surfeit of information and data in medicine with limited human resources. The limitations and risks of AI applications require critical and responsible consideration. This can best be achieved through a combination of scientific.

The effects of hydrocortisone and yohimbine on human behavior in approach-avoidance conflicts.

RATIONALE: Balancing approach of positive and avoidance of negative stimuli is essential when faced with approach-avoidance conflicts, e.g., situations with both positive and negative outcomes. This balance is disturbed in several mental disorders, e.g., excessive avoidance in anxiety disorders, and heightened approach in substance use disorders. Since stress is assumed to impact these disorders' etiology and maintenance, it seems crucial to understand how stress influences behavior in approach-avoidance conflicts. Indeed, some studies suggested altered approach-avoidance behavior under acute stress, but the mechanism underlying these effects is unknown. OBJECTIVES: Investigate how the pharmacological manipulation of major stress mediators (cortisol and noradrenaline) influences task-based approach-avoidance conflict behavior in healthy individuals. METHODS: Ninety-six participants (48 women, 48 men) received either 20mg hydrocortisone, 20mg yohimbine, both, or placebo before performing a task targeting foraging under predation in a fully crossed double-blind between-subject design. Moreover, we investigated effects of gender and endogenous testosterone and estradiol levels on approach-avoidance behavior. RESULTS: While biological stress markers (cortisol concentration, alpha amylase activity) indicated successful pharmacological manipulation, behavior in approach-avoidance conflicts was not affected as expected. Although yohimbine administration affected risky foraging latency under predation, we found no main effect of hydrocortisone or their interaction on behavior. In contrast, we found gender differences for almost all behavioral outcome measures, which might be explained by differences in endogenous testosterone levels. CONCLUSIONS: The investigated major stress mediators were not sufficient to imitate previously shown stress effects on approach-avoidance conflict behavior. We discuss potential reasons for our findings and implications for future research.

Comprehensive Implementation of Shared Decision Making in a Neuromedical Center Using the SHARE TO CARE Program.

Purpose: SHARE TO CARE (S2C) is a comprehensive, multi-module implementation program for shared decision making (SDM). It is currently applied at the University Hospital Schleswig-Holstein in Kiel, Germany, and among general practitioners at the Federal State of Bremen. This study examines the results of the full implementation of S2C in terms of effectiveness within the Kiel Neuromedical Center comprising the departments of neurology and neurosurgery. Method and Design: The S2C program consists of four combined intervention modules: 1) multimodal training of physicians; 2) a patient activation campaign including the ASK-3 method; 3) digital evidence-based patient decision aids; and 4) SDM support by nurses, e.g., as decision coaches. The SDM level before and immediately after implementation was retrospectively assessed in consecutively selected patients on the subscale "Patient Decision Making" of the Perceived Involvement in Care Scale (PICSPDM). Mean scores were compared with t-tests. Results: Eighty-nine percent of all physicians (N = 56) completed the SDM training. We developed a total of 12 evidence-based digital decision aids in the center, educated two decision coaches to support patients' decision processes by using decision aids. Physicians adjusted patients' pathways to incorporate the use of decision aids. Patients (n = 261) reported a significant increase in participation (p<0.001; Hedges' g = 0.49) in medical decision making. Conclusion: The S2C program has been successfully implemented within the entire Neuromedical Center. Patients reported a medium to small increase of perceived involvement in decision making demonstrating the effectiveness of the implementation. For future research, it might be interesting to investigate the sustainability of the effects of S2C. In addition, it seems useful to complement the patient-based evaluation with observer-based data.

Sustainability of large-scale implementation of shared decision making with the SHARE TO CARE program.

Introduction: SHARE TO CARE (S2C) is a comprehensive implementation program for shared decision making (SDM). It is run at the University Hospital Schleswig-Holstein (UKSH) in Kiel, Germany, and consists of four combined intervention modules addressing healthcare professionals and patients: (1) multimodal training of physicians (2) patient activation campaign including the ASK3 method, (3) online evidence-based patient decision aids (4) SDM support by nurses. This study examines the sustainability of the hospital wide SDM implementation by means of the Neuromedical Center comprising the Departments of Neurology and Neurosurgery. Methods: Between 2018 and 2020, the S2C program was applied initially within the Neuromedical Center: We implemented the patient activation campaign, trained 89% of physicians (N = 56), developed 12 patient decision aids and educated two decision coaches. Physicians adjusted the patients' pathways to facilitate the use of decision aids. To maintain the initial implementation, the departments took care that new staff members received training and decision aids were updated. The patient activation campaign was continued. To determine the sustainability of the initial intervention, the SDM level after a maintenance phase of 6-18 months was compared to the baseline level before implementation. Therefore, in- and outpatients received a questionnaire via mail after discharge. The primary endpoint was the "Patient Decision Making" subscale of the Perceived Involvement in Care Scale (PICSPDM). Secondary endpoints were an additional scale measuring SDM (CollaboRATE), and the PrepDM scale, which determines patients' perceived health literacy while preparing for decision making. Mean scale scores were compared using t-tests. Results: Patients reported a significantly increased SDM level (PICSPDM p = 0.02; Hedges' g = 0.33; CollaboRATE p = 0.05; Hedges' g = 0.26) and improved preparation for decision making (PrepDM p = 0.001; Hedges' g = 0.34) 6-18 months after initial implementation of S2C. Discussion: The S2C program demonstrated its sustainability within the Neuromedical Center at UKSH Kiel in terms of increased SDM and health literacy. Maintaining the SDM implementation required a fraction of the initial intensity. The departments took on the responsibility for maintenance. Meanwhile, an additional health insurance-based reimbursement for S2C secures the continued application of the program. Conclusion: SHARE TO CARE promises to be suitable for long-lasting implementation of SDM in hospitals.

The effect of a scalable online training module for shared decision making based on flawed video examples - a randomized controlled trial.

OBJECTIVE: Shared Decision Making (SDM) is considered the gold standard of medical decision making as it provides a method to systematically integrate the patient's preferences, evidence-based medicine and the experience of health care professionals. Therefore, evidence-based training methods for a broad implementation into healthcare are needed. A new online training was designed, based on the concept of flawed/flawless video examples and additional educational concepts. METHODS: In a single-blind randomized-controlled trial, medical students were randomly assigned to intervention group receiving the online training (n = 82) or waiting control group (n = 105). SDM-related knowledge and the ability to judge distinct levels of SDM were compared between both groups. Additionally, feedback regarding the intervention was collected. RESULTS: SDM-related knowledge and judging ability increased significantly in the intervention group compared to controls (SDM knowledge: mean difference: 12 %; 95 % CI: 7.3-18.5; p < 0.001; SDM judging ability (inter-rater concordance displayed by weighted t): mean difference: 0.07; 95 %CI: 0.03-0.11; p = 0.001). Feedback was positive. CONCLUSION: The online training with its distinctive methodology prove effective. As it shares the theoretical and didactical background with an already existing face-to-face training, both approaches may also be used complementarily. PRACTICE IMPLICATIONS: SDM can be trained effectively and efficiently with this easily scalable online training.

Enhancing Specific Health Literacy with a Digital Evidence-Based Patient Decision Aid for Hypertension: A Randomized Controlled Trial.

INTRODUCTION: Health literacy is an important competency to make informed, shared decisions in line with patient's preferences. On the other hand, lower health literacy is associated with poorer health outcomes. Evidence-based patient decision aids (EbPDA) are validated instruments to support informed medical decisions and empower patients for relevant involvement in their care. This study aimed to investigate the effect of a digital EbPDA for hypertension on health literacy. METHODS: In a randomized controlled trial, 124 participants were presented with a web-based scenario related to a newly diagnosed condition of arterial hypertension. The intervention group was provided with an online decision aid, while the control group was prompted to search for related information without support. Specific health literacy for hypertension was operationalized based on the European survey for health literacy (HLS-EU-Q47). RESULTS: The intervention group showed a statistically significant increase in subjectively perceived overall specific health literacy regarding hypertension (p=0.02, Cohen's d=0.44). The effect was also statistically significant for the subcategories understanding, appraising, and applying health-related information (all p<0.05). At least equal results could be shown for participants with a lower level of education compared to participants with a high level. CONCLUSION: The findings suggest that digital EbPDAs can be an effective and easily scalable instrument to improve populations' specific health literacy. A possible advantage of the measure could be that patients are addressed concerning important and pressing personal decisions, fostering awareness of the individual's need for health literacy to reflect one's options and preferences. EbPDAs may also be a promising approach to target vulnerable populations, as the investigated EbPDA seems to perform equally in less versus more educated individuals. For future research, it may be interesting to investigate whether EbPDAs have effects on general health literacy that go beyond the disease specifically addressed.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis: a systematic review and meta-analysis.

OBJECTIVES: Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). The choice of procedure depends on several factors, including the clinical judgement of the heart team and patient preferences, which are captured by actively informing and involving patients in a process of shared decision making (SDM). We synthesised the most up-to-date and accessible evidence on the benefits and risks that may be associated with TAVI versus SAVR to support SDM in this highly personalised decision-making process. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE (Ovid), Embase (Ovid) and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley) were searched from January 2000 to August 2020 with no language restrictions. Reference lists of included studies were searched to identify additional studies. ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) that compared TAVI versus SAVR in patients with SAS and reported on all-cause or cardiovascular mortality, length of stay in intensive care unit or hospital, valve durability, rehospitalisation/reintervention, stroke (any stroke or major/disabling stroke), myocardial infarction, major vascular complications, major bleeding, permanent pacemaker (PPM) implantation, new-onset or worsening atrial fibrillation (NOW-AF), endocarditis, acute kidney injury (AKI), recovery time or pain were included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers were involved in data extraction and risk of bias (ROB) assessment using the Cochrane tool (one reviewer extracted/assessed the data, and the second reviewer checked it). Dichotomous data were pooled using the Mantel-Haenszel method with random-effects to generate a risk ratio (RR) with 95% CI. Continuous data were pooled using the inverse-variance method with random-effects and expressed as a mean difference (MD) with 95% CI. Heterogeneity was assessed using the I2 statistic. RESULTS: 8969 records were retrieved and nine RCTs (61 records) were ultimately included (n=8818 participants). Two RCTs recruited high-risk patients, two RCTs recruited intermediate-risk patients, two RCTs recruited low-risk patients, one RCT recruited high-risk (≥70 years) or any-risk (≥80 years) patients; and two RCTs recruited all-risk or 'operable' patients. While there was no overall change in the risk of dying from any cause (30 day: RR 0.89, 95% CI 0.65 to 1.22; ≤1 year: RR 0.90, 95% CI 0.79 to 1.03; 5 years: RR 1.09, 95% CI 0.98 to 1.22), cardiovascular mortality (30 day: RR 1.03, 95% CI 0.77 to 1.39; ≤1 year: RR 0.90, 95% CI 0.76 to 1.06; 2 years: RR 0.96, 95% CI 0.83 to 1.12), or any type of stroke (30 day: RR 0.83, 95% CI 0.61 to 1.14;≤1 year: RR 0.94, 95% CI 0.72 to 1.23; 5 years: RR 1.07, 95% CI 0.88 to 1.30), the risk of several clinical outcomes was significantly decreased (major bleeding, AKI, NOW-AF) or significantly increased (major vascular complications, PPM implantation) for TAVI vs SAVR. TAVI was associated with a significantly shorter hospital stay vs SAVR (MD -3.08 days, 95% CI -4.86 to -1.29; 4 RCTs, n=2758 participants). Subgroup analysis generally favoured TAVI patients receiving implantation via the transfemoral (TF) route (vs non-TF); receiving a balloon-expandable (vs self-expanding) valve; and those at low-intermediate risk (vs high risk). All RCTs were rated at high ROB, predominantly due to lack of blinding and selective reporting. CONCLUSIONS: No overall change in the risk of death from any cause or cardiovascular mortality was identified but 95% CIs were often wide, indicating uncertainty. TAVI may reduce the risk of certain side effects while SAVR may reduce the risk of others. Most long-term (5-year) results are limited to older patients at high surgical risk (ie, early trials), therefore more data are required for low risk populations. Ultimately, neither surgical technique was considered dominant, and these results suggest that every patient with SAS should be individually engaged in SDM to make evidence-based, personalised decisions around their care based on the various benefits and risks associated with each treatment. PROSPERO REGISTRATION NUMBER: CRD42019138171.

Making shared decision-making (SDM) a reality: protocol of a large-scale long-term SDM implementation programme at a Northern German University Hospital.

INTRODUCTION: Shared decision-making (SDM) is not yet widely used when making decisions in German hospitals. Making SDM a reality is a complex task. It involves training healthcare professionals in SDM communication and enabling patients to actively participate in communication, in addition to providing sound, easy to understand information on treatment alternatives in the form of evidence-based patient decision aids (EbPDAs). This project funded by the German Innovation Fund aims at designing, implementing and evaluating a multicomponent, large-scale and integrative SDM programme-called SHARE TO CARE (S2C)-at all clinical departments of a University Hospital Campus in Northern Germany within a 4-year time period. METHODS AND ANALYSIS: S2C tackles the aforementioned components of SDM: (1) training physicians in SDM communication, (2) activating and empowering patients, (3) developing EbPDAs in the most common/relevant diseases and (4) training other healthcare professionals in SDM coaching. S2C is designed together with patients and providers. The physicians' training programme entails an online and an in situ training module. The decision coach training is based on a similar but less comprehensive approach. The development of online EbPDAs follows the International Patient Decision Aid Standards and includes written, graphical and video-based information. Validated outcomes of SDM implementation are measured in a preintervention and postintervention evaluation design. Process evaluation accompanies programme implementation. Health economic impact of the intervention is investigated using a propensity-score-matched approach based on potentially preference-sensitive hospital decisions. ETHICS AND DISSEMINATION: Ethics committee review approval has been obtained from Medical Ethics Committee of the Medical Faculty of the Christian-Albrechts-University Kiel. Project information and results will be disseminated at conferences, on project-hosted websites at University Hospital Medical Center Schleswig Holstein and by S2C as well as in peer-reviewed and professional journals.

Combination of National Quality Assurance Data Collection With a Standard Operating Procedure in Community-Acquired Pneumonia: A Win-Win Strategy?

PURPOSE: The primary contact for German physicians with national quality assurance in community-acquired pneumonia (CAP) is frequently experienced as time-consuming obligatory documentation. Since the regular feedback loop stretches up to 18 months, the immediate impact on quality is perceived as rather low. Ultimately, a method leading to increase in the quality of data collection, clarification on expected clinical treatment standards, and improvement in the acceptance and feedback mechanism is needed. METHODS: We developed a form merging data collection for quality indicators with a standard operating procedure (SOP) in CAP and implemented it in the daily routine of a university's department for internal medicine. Fulfillment of quality indicators before and after the implementation of the new form was measured. RESULTS: Critical parameters such as the documentation of breathing rate and clinical parameters at discharge strongly improved after implementation of the intervention. Uncritical parameters showed slight improvement or stable results at a high level. CONCLUSION: The combination of collection of quality data with a clinical SOP and context information may improve the impact of quality measures by increasing acceptance, quality of data capture, short-loop feedback, and possibly quality of care.

Pseudomonas aeruginosa- and IL-1beta-mediated induction of human beta-defensin-2 in keratinocytes is controlled by NF-kappaB and AP-1.

Human beta-defensin-2 (hBD-2) is an inducible epithelial peptide antibiotic involved in cutaneous defense. Expression of hBD-2 in keratinocytes is strongly induced by IL-1beta and culture supernatants of Pseudomonas aeruginosa (PA). The use of an IL-1 receptor antagonist revealed that PA-mediated induction of hBD-2 is not dependent on IL-1. Luciferase gene reporter experiments, demonstrated that a 2,338 bp promoter fragment of hBD-2 containing three putative NF-kappaB as well as one activator protein-1 (AP-1) binding site was strongly activated by IL-1beta and PA. Mutation of all NF-kappaB binding sites together with mutation of the AP-1 binding site completely abolished hBD-2 promoter activation by IL-1beta and PA. Treatment with the NF-kappaB inhibitor Helenalin as well as with the c-Jun N-terminal kinase (JNK) inhibitor SP600125 and the p38 mitogen-activated protein kinase inhibitor SB 202190 blocked hBD-2 induction by IL-1beta and PA. PD 98059, a selective inhibitor of extracellular signal-regulated kinase 1/2 demonstrated no significant influence. Transcription factor ELISAs indicated that the NF-kappaB heterodimer p50-p65 binds to all three NF-kappaB sites in the hBD-2 promoter upon stimulation of primary keratinocytes with IL-1beta and PA. We conclude that the activation of NF-kappaB (p50-p65) and AP-1 are crucial events for induction of hBD-2 in keratinocytes upon IL-1beta and PA stimulation.

Differential gene induction of human beta-defensins (hBD-1, -2, -3, and -4) in keratinocytes is inhibited by retinoic acid.

Human skin is able to mount a fast response against invading harmful bacteria through the rapid production of inducible peptide antibiotics such as the human beta-defensins (hBD). To gain more insight into the role and regulation of inducible beta-defensins in the innate immunity of human skin, we investigated whether gene induction of the human beta-defensins hBD-1, -2, -3, and -4 in keratinocytes is regulated in a similar manner. Therefore, we performed a comparative study of gene expression of these four hBD in primary cultured keratinocytes using real-time PCR. A basal mRNA expression was observed for all four hBD in primary keratinocytes, which strongly increased for hBD-2, -3, and -4 during Ca(2+)-induced differentiation of the keratinocytes. This effect was completely abolished when the keratinocytes were pre-treated with all-trans-retinoic acid (RA). Furthermore, the differential induction of hBD-2, -3, and -4 gene expression in keratinocytes by proinflammatory cytokines, phorbol-myristate-acetate (PMA), and bacteria was inhibited by more than 90% when the keratinocytes were pre-incubated with RA. Inhibition of IL-1beta-mediated hBD-2 induction through RA was further confirmed by gene reporter assays and western-blot analysis. We conclude that RA is a potent inhibitor of beta-defensin induction in keratinocytes and might downregulate the inducible innate chemical defense system of human skin.