Development and implementation of a treatment pathway to reduce coronary angiograms - lessons from a failure.

BACKGROUND: The rates of coronary angiograms (CA) and related procedures (percutaneous intervention [PCI]) are significantly higher in Germany than in other Organisation for Economic Co-ordination and Development (OECD) countries. The current guidelines recommend non-invasive diagnosis of coronary heart disease (CHD); CA should only have a limited role in choosing the appropriate revascularisation procedure. The aim of the present study was to explore whether improvements in guideline adherence can be achieved through the implementation of regional treatment pathways. We chose four regions of Germany with high utilisation of CAs for the study. Here we report the results of the concomitant qualitative study. METHODS: General practitioners and specialist physicians (cardiologists, hospital-based cardiologists, emergency physicians, radiologists and nuclear medicine specialists) caring for patients with suspected CHD were invited to develop regional treatment pathways. Four academic departments provided support for moderation, provision of materials, etc. The study team observed session discussions and took notes. After the development of the treatment pathways, 45 semi-structured interviews were conducted with the participating physicians. Interviews and field notes were transcribed verbatim and underwent qualitative content analysis. RESULTS: Pathway development received little support among the participants. Although consensus documents were produced, the results were unlikely to improve practice. The participants expressed very little commitment to change. Although this attempt clearly failed in all study regions, our experience provides relevant insights into the process of evidence appraisal and implementation. A lack of organisational skills, ignorance of current evidence and guidelines, and a lack of feedback regarding one's own clinical behaviour proved to be insurmountable. CA was still seen as the diagnostic gold standard by most interviewees. CONCLUSIONS: Oversupply and overutilisation can be assumed to be present in study regions but are not immediately perceived by clinicians. The problem is unlikely to be solved by regional collaborative initiatives; optimised resource planning within the health care system combined with appropriate economic incentives might best address these issues.

A volunteer-supported walking programme to improve physical function in older people with restricted mobility (the POWER Study): a randomised controlled trial.

BACKGROUND: Regular physical activity has multiple health benefits, especially in older people. Therefore, the World Health Organization recommends at least 2.5 h of moderate physical activity per week. The aim of the POWER Study was to investigate whether volunteer-assisted walking improves the physical performance and health of older people. METHODS: We approached people aged 65 years and older with restricted mobility due to physical limitations and asked them to participate in this multicentre randomised controlled trial. The recruitment took place in nursing homes and the community setting. Participants randomly assigned to the intervention group were accompanied by volunteer companions for a 30-50 min walk up to three times a week for 6 months. Participants in the control group received two lectures that included health-related topics. The primary endpoint was physical function as measured with the Short Physical Performance Battery (SPPB) at baseline and 6 and 12 months. The secondary and safety endpoints were quality of life (EQ-5D-5L), fear of falling (Falls Efficacy Scale), cognitive executive function (the Clock Drawing Test), falls, hospitalisations and death. RESULTS: The sample comprised 224 participants (79% female). We failed to show superiority of the intervention with regard to physical function (SPPB) or other health outcomes in the intention-to-treat analyses. However, additional exploratory analyses suggest benefits in those who undertook regular walks. The intervention appears to be safe regarding falls. CONCLUSIONS: Regular physical activity is essential to preserve function and to improve health and quality of life. Against the background of a smaller-than-planned sample size, resulting in low power, and the interference of the COVID-19 pandemic, we suggest that community based low-threshold interventions deserve further exploration. TRIAL REGISTRATION: The trial was registered with the German Clinical Trials Register ( www.germanctr.de ), with number DRKS00015188 on 31/08/2018.

[Improving Postgraduate Medical Training In Germany: A Proposal]. / Ein Vorschlag zur Förderung der ärztlichen Weiterbildung im Kontext einer reformierten Krankenhausfinanzierung.

Postgraduate (vocational, residency) training in Germany is regulated by the Physicians' Chamber in each federal state. Although training requirements are specified in detail by regulatory documents, young doctors are left on their own to find training posts and suitable learning experiences. There are no programmes in place to support trainees nor to identify the need of the health care system regarding the composition of its medical workforce. Hospitals and practices pay salaries to physicians in training from funding obtained for services they provide. We propose a systematic and continuing process of identifying gaps in the workforce. Disciplines with a lack of qualified doctors will be supported by additional funds directed to practices and hospitals. Regional rotation schemes will coordinate and improve the quality of training. Apart from an administrative overhead, this system of regulation will not need additional resources because a limited part of current budgets will be explicitly channelled into salaries for trainees in specialties for which there is a higher need than into others.

Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial.

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI - 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI - 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (- 10.2%, 95% CI - 6.01 to - 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

Physicians' assessment of the Bavarian drug-expenditure control system: a qualitative study.

BACKGROUND: In 2014 a new system for drug expenditures, the Wirkstoffvereinbarung (WSV, English: Active substance agreement) was implemented in Bavaria. In pre-defined indication groups, economic prescription of medications shall be enabled based on the selection, quantity, and proportion of an individual drug. Ambulatory care physicians receive quarterly trend reports on their prescribing behavior. This study examines physicians' perceptions of the WSV. METHODS: Qualitative interviews (n = 20) and seven focus groups (n = 36) were conducted with ambulatory care physicians (e.g. general practitioners, cardiologists, pulmonologists). The methodology followed Qualitative Content Analysis. RESULTS: Physicians generally accepted the necessity of prescribing economically. The majority of them rated the WSV positively and better than the previous system. As an improvement, they especially named timely feedback in form of easily understandable trend reports, encouraging self-reflection as well as allowing early control options. Problems perceived were drug discount contracts that were strongly criticized as leading to patients mixing up medications. Some perceived constraints of therapeutic freedom. CONCLUSIONS: The implementation of the WSV is mostly viewed positively by physicians. The restrictions of therapeutic freedom partially perceived might be met by improved information on the reasons why some drugs are rated as less economical than others. TRIAL REGISTRATION NUMBER: Main ID: DRKS00019820 (German Register of Clinical Studies and World Health Organization).

Experiences of participants of a volunteer-supported walking intervention to improve physical function of nursing home residents - a mixed methods sub-study of the POWER-project.

BACKGROUND: Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled "Prevention by lay-assisted Outdoor-Walking in the Elderly at Risk" POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers' experience with people living in nursing homes during the first pandemic lockdown (spring 2020). METHODS: The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. RESULTS: Participants' evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. CONCLUSION: Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. TRIAL REGISTRATION: DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

Determinants of referral for suspected coronary artery disease: a qualitative study based on decision thresholds.

BACKGROUND: Chest pain is a frequent consultation issue in primary care, with coronary artery disease (CAD) being a serious potential cause. Primary care physicians (PCPs) assess the probability for CAD and refer patients to secondary care if necessary. Our aim was to explore PCPs' referral decisions, and to investigate determinants which influenced those decisions. METHODS: PCPs working in Hesse, Germany, were interviewed in a qualitative study. We used 'stimulated recall' with participants to discuss patients with suspected CAD. With a sample size of 26 cases from nine practices we reached inductive thematic saturation. Interviews were audio-recorded, transcribed verbatim and analyzed by inductive-deductive thematic content analysis. For the final interpretation of the material, we used the concept of decision thresholds proposed by Pauker and Kassirer. RESULTS: PCPs reflected on their decisions for or against a referral. Aside from patient characteristics determining disease probability, we identified general factors which can be understood as influencing the referral threshold. These factors relate to the practice environment, to PCPs themselves and to non-diagnostic patient characteristics. Proximity of specialist practice, relationship with specialist colleagues, and trust played a role. PCPs sometimes felt that invasive procedures were performed too easily. They tried to steer their patients through the system with the intent to avoid over-treatment. Most PCPs were unaware of guidelines but relied on informal local consensus, largely influenced by specialists. As a result, PCPs gatekeeping role was limited. CONCLUSIONS: We could identify a large number of factors that impact referral for suspected CAD. Several of these factors offer possibilities to improve care at the clinical and system level. The threshold model proposed by Pauker and Kassirer was a useful framework for this kind of data analysis.

Influence of a guideline or an additional rapid strep test on antibiotic prescriptions for sore throat: the cluster randomized controlled trial of HALS (Hals und Antibiotika Leitlinien Strategien).

BACKGROUND: Pharyngitis due to Group A beta-hemolytic streptococci (GAS) is seen as the main indication for antibiotics for sore throat. In primary care settings prescription rates are much higher than the prevalence of GAS. Recommendations in international guidelines differ considerably. A German guideline suggested to consider antibiotics for patients with Centor or McIsaac scores ≥ 3, first choice being penicillin V for 7 days, and recommended analgesics for all. We investigated, if the implementation of this guideline lowers the antibiotic prescription rate, and if a rapid antigen detection strep-test (RADT) in patients with scores ≥ 3 lowers the rate further. METHODS: HALS was an open pragmatic parallel group three-arm cluster-randomized controlled trial. Primary care practices in Northern Germany were randomized into three groups: Guideline (GL-group), modified guideline with a RADT for scores ≥ 3 (GL-RADT-group) or usual care (UC-group). All practices were visited and instructed by the study team (outreach visits) and supplied with material according to their group. The practices were asked to recruit 11 consecutive patients ≥ 2 years with an acute sore throat and being at least moderately impaired. A study throat swab for GAS was taken in every patient. The antibiotic prescription rate at the first consultation was the primary outcome. RESULTS: From October 2010 to March 2012, 68 general practitioners in 61 practices recruited 520 patients, 516 could be analyzed for the primary endpoint. Antibiotic prescription rates did not differ between groups (p = 0.162) and were about three times higher than the GAS rate: GL-group 97/187 patients (52%; GAS = 16%), GL-RADT-group 74/172 (43%; GAS = 16%) and UC-group 68/157 (43%; GAS = 14%). In the GL-RADT-group 55% of patients had scores ≥ 3 compared to 35% in GL-group (p < 0.001). After adjustment, in the GL-RADT-group the OR was 0.23 for getting an antibiotic compared to the GL-group (p = 0.010), even though 35 of 90 patients with a negative Strep-test got an antibiotic in the GL-RADT-group. The prescription rates per practice covered the full range from 0 to 100% in all groups. CONCLUSION: The scores proposed in the implemented guideline seem inappropriate to lower antibiotic prescriptions for sore throat, but better adherence of practitioners to negative RADTs should lead to fewer prescriptions. TRIAL REGISTRATION: DRKS00013018, retrospectively registered 28.11.2017.

Anticholinergic burden measures, symptoms, and fall-associated risk in older adults with polypharmacy: Development and validation of a prognostic model.

BACKGROUND: Anticholinergic burden has been associated with adverse outcomes such as falls. To date, no gold standard measure has been identified to assess anticholinergic burden, and no conclusion has been drawn on which of the different measure algorithms best predicts falls in older patients from general practice. This study compared the ability of five measures of anticholinergic burden to predict falls. To account for patients' individual susceptibility to medications, the added predictive value of typical anticholinergic symptoms was further quantified in this context. METHODS AND FINDINGS: To predict falls, models were developed and validated based on logistic regression models created using data from two German cluster-randomized controlled trials. The outcome was defined as "≥ 1 fall" vs. "no fall" within a 6-month follow-up period. Data from the RIME study (n = 1,197) were used in model development, and from PRIMUM (n = 502) for external validation. The models were developed step-wise in order to quantify the predictive ability of anticholinergic burden measures, and anticholinergic symptoms. In the development set, 1,015 patients had complete data and 188 (18.5%) experienced ≥ 1 fall within the 6-month follow-up period. The overall predictive value of the five anticholinergic measures was limited, with neither the employed anticholinergic variable (binary / count / burden), nor dose-dependent or dose-independent measures differing significantly in their ability to predict falls. The highest c-statistic was obtained using the German Anticholinergic Burden Score (0.73), whereby the optimism-corrected c-statistic was 0.71 after interval validation using bootstrapping and 0.63 in the external validation. Previous falls and dizziness / vertigo had the strongest prognostic value in all models. CONCLUSIONS: The ability of anticholinergic burden measures to predict falls does not appear to differ significantly, and the added value they contribute to risk classification in fall-prediction models is limited. Previous falls and dizziness / vertigo contributed most to model performance.

Diffusion of a new drug among ambulatory physicians-The impact of patient pathways.

When drugs enter the market, physicians' prescribing behavior plays a crucial role in the diffusion process. Although regulations to foster economically efficient prescribing exist, physicians have some degree of freedom in choosing medication and are subject to various influencing factors. The aim of the present analysis is to investigate how interaction among patients and physicians affects the diffusion. We look at two different ways that patient pathways might influence physicians and examine these effects for Sacubitril/Valsartan (S/V), a new drug for patients with heart failure. Using administrative data from Germany, we identify physicians who prescribed S/V in the first 2 years of its availability. We apply survival models to estimate the impact of the patient-physician interaction on the physicians' adoption time. To this end, we determine whether individual physicians treated patients that had been prescribed S/V, and how many other physicians already prescribing S/V were connected in patient-sharing networks. Our main findings are that patients with a previous prescription seem to induce adoption by demanding repeat prescriptions. Moreover, patients establish connections between physicians that may lead to prescriptions for new patients. Our results therefore suggest that patient pathways play a significant role in the diffusion of a new drug.

Mapping the methodological diversity of published drug discontinuation studies-a scoping review of study topics, objectives, and designs.

BACKGROUND: Trials evaluating drug discontinuation (drug discontinuation trials, DDTs) show a broad methodological spectrum. There are several specific methodological aspects in drug discontinuation trials (e.g., determination of research question; configuration of intervention; definition of outcomes). To verify this specifies, we did a scoping review about the study designs of drug discontinuation trials. METHODS: A systematic literature search in Medline (PubMed), The Cochrane Library, EMBASE, CINAHL, Web of Science, and PsycINFO was performed. In a two-step selection process, we identified DDTs, which evaluate the discontinuation of one or more long-term medication as the investigated intervention, by two independent reviewers. Besides bibliographic data, we extracted several parameters to describe the used study design of the included DDTs: motivation for DDT, initially treatment aim of the discontinued medication, study design, methods of discontinuation, follow-up times, number of study participants, and outcome parameter. RESULTS: Out of 12,132 records, we included 581 DDTs. The most common motivation for doing a DDT were expected side effects (48.8%), the motivation of proving the efficacy of medication (21.6%), or doubts on the expected benefit of the used medication (13.8%). The majority of the discontinued medication was initially prescribed to improve the prognosis of a chronic disease (60.4%) or to relieve symptoms (31%). The study designs of the trials showed a broad methodological spectrum. The minority of the drug discontinuation trials were randomized controlled trials (34%). CONCLUSION: The results of this scoping review illustrates the need for an evidence-based methodological standard for planning and conducting drug discontinuation trials.

Educating physicians on strong opioids by descriptive versus simulated-experience formats: a randomized controlled trial.

BACKGROUND: Long-term prescriptions of strong opioids for chronic noncancer pain-which are not supported by scientific evidence-suggest miscalibrated risk perceptions among those who prescribe, dispense, and take opioids. Because risk perceptions and behaviors can differ depending on whether people learn about risks through description or experience, we investigated the effects of descriptive versus simulated-experience educative formats on physicians' risk perceptions of strong opioids and their prescription behavior for managing chronic noncancer pain. METHODS: Three hundred general practitioners and 300 pain specialists in Germany-enrolled separately in two independent exploratory randomized controlled online trials-were randomly assigned to either a descriptive format (fact box) or a simulated-experience format (interactive simulation). PRIMARY ENDPOINTS: Objective risk perception (numerical estimates of opioids' benefits and harms), actual prescriptions of seven therapy options for managing chronic pain. SECONDARY ENDPOINT: Implementation of intended prescriptions of seven therapy options for managing chronic pain. RESULTS: Both formats improved the proportion of correct numerical estimates of strong opioids' benefits and harms immediately after intervention, with no notable differences between formats. Compared to description, simulated experience led to significantly lower reported actual prescription rates for strong and/or weak opioids, and was more effective at increasing prescription rates for non-drug-based therapies (e.g., means of opioid reduction) from baseline to follow-up for both general practitioners and pain specialists. Simulated experience also resulted in a higher implementation of intended behavior for some drug-based and non-drug-based therapies. CONCLUSIONS: The two formats, which recruit different cognitive processes, may serve different risk-communication goals: If the goal is to improve exact risk perception, descriptive and simulated-experience formats are likely to be equally suitable. If, however, the goal is to boost less risky prescription habits, simulated experience may be the better choice. TRIAL REGISTRATION: DRKS00020358 (German Clinical Trials Register, first registration: 07/01/2020).

MediQuit - an electronic deprescribing tool: a pilot study in German primary care; GPs' and patients' perspectives.

BACKGROUND: General practitioners (GPs) are the central coordinators for patients with multimorbidity and polypharmacy in most health care systems. They are entrusted with the challenging task of deprescribing when inappropriate polypharmacy is present. MediQuit (MQu) is a newly developed electronic tool that guides through a deprescribing consultation. It facilitates the identification of a medicine to be discontinued (stage 1), a shared decision-making process weighing the pros and cons (stage 2), and equips patients with take-home instructions on how to discontinue the drug and monitor its impact (stage 3). We here aim to evaluate utility and acceptance of MQu from GPs' and patients' perspectives. METHODS: Uncontrolled feasibility study, in which 16 GPs from two regions in Germany were invited to use MQu in consultations with their multimorbid patients. We collected quantitative data on demography, utility and acceptance of MQu and performed descriptive statistical analyses. RESULTS: Ten GPs performed 41 consultations using MQu. Identification (step 1) and implementation elements (Step 3) were perceived most helpful by GPs. Whereas, shared-decision making elements (step 2) revealed room for improvement. Patients appreciated the use of MQu. They were broadly satisfied with the deprescribing consultation (85%) and with their decision made regarding their medication (90%). CONCLUSIONS: Implementation of MQu in general practice generally seems possible. Patients welcome consultations targeting medication optimization. GPs were satisfied with the support of MQu and likewise gave important hints for future development.

[Prescribing behavior of Bavarian general practitioners at the inpatient-outpatient interface within the context of the Bavarian active substance agreement-qualitative results of the WirtMed Study]. / Verordnungsverhalten von bayerischen Hausärzt*innen an der stationär-ambulanten Schnittstelle vor dem Hintergrund der Bayerischen Wirkstoffvereinbarung ­ Qualitative Ergebnisse der WirtMed-Studie.

BACKGROUND AND OBJECTIVES: In 2014, the Association of Statutory Health Insurance Physicians of Bavaria introduced the active substance agreement (WSV) for the transparent control of pharmaceutical expenditure within the framework of the efficiency principle (§ 12 of the Fifth Book of the German Social Code [SGB V]). It replaced the prescribing target scheme. Regarding the role of the WSV, the article presents the reasons of the general practitioners (GPs) for or against a further prescription of drugs from the hospital. MATERIALS AND METHODS: In a qualitative study design, individual interviews (n = 18) and two focus groups (n = 10) were conducted with Bavarian GPs between November 2019 and March 2020 and evaluated according to qualitative content analysis. RESULTS: With the introduction of the WSV, recourse concerns decreased for GPs overall. Patient-oriented care and the professional correctness of therapy decisions are of great importance in prescribing, ahead of cost-effectiveness. Economic challenges arise with discharge medication, especially with the lead substance target of oral anticoagulants, the generic targets for antidiabetics, and for therapeutics for the cardiovascular system. Generally criticized are drug discount contracts, which often lead to drug changes after hospital discharge. There are individual reports of a "predominance" of hospital physicians when prescribing, which is contrary to their own economic actions as GPs. According to the GPs, there is a lack of cross-sectoral cost responsibility. CONCLUSIONS: In the view of GPs, a smooth interface transition is not yet available in the outpatient sector despite a framework agreement on discharge management and the new control system of the WSV. An economical supply of drugs continues to require political discussion across sectors, but also across federal states.

Identifying and Investigating Ambulatory Care Sequences Before Invasive Coronary Angiography.

BACKGROUND: The concept of care pathways is widely used to provide efficient, timely, and evidence-based medical care. Recently, the investigation of actual empirical patient pathways has gained attention. We demonstrate the usability of State Sequence Analysis (SSA), a data mining approach based on sequence clustering techniques, on comprehensive insurance claims data from Germany to identify empirical ambulatory care sequences. We investigate patients with coronary artery disease before invasive coronary angiography (CA) and compare identified patterns with guideline recommendations. This patient group is of particular interest due to high and regionally varying CA rates. METHODS: Events relevant for the care of coronary artery disease patients, namely physician consultations and medication prescriptions, are identified based on medical guidelines and combined to define states. State sequences are determined for 1.5 years before CA. Sequence similarity is defined for clustering, using optimal matching with theory-informed substitution costs. We visualize clusters, present descriptive statistics, and apply logistic regression to investigate the association of cluster membership with subsequent undesired care events. RESULTS: Five clusters are identified, the included patients differing with respect to morbidity, urbanity of residential area, and health care utilization. Clusters exhibit significant differences in the timing, structure, and extent of care before CA. When compared with guideline recommendations, 3 clusters show signs of care deficits. CONCLUSIONS: Our analyses demonstrate the potential of SSA for exploratory health care research. We show how SSA can be used on insurance claims data to identify, visualize, and investigate care patterns and their deviations from guideline recommendations.

Self-Reported Practices and Emotions in Prescribing Opioids for Chronic Noncancer Pain: A Cross-Sectional Study of German Physicians.

Background: The pressure on physicians when a patient seeks pain relief and their own desire to be self-effective may lead to the prescription of strong opioids for chronic noncancer pain (CNCP). This study, via physician self-reporting, aims to identify and measure (i) physician adherence to national opioid prescribing guidelines and (ii) physician emotions when a patient seeks a dosage increase of the opioid. Methods: Within a cross-sectional survey­conducted as part of a randomized controlled online intervention trial (ERONA)­600 German physicians were queried on their opioid prescribing behavior (choice and formulation of opioid, indications) for CNCP patients and their emotions to a case vignette describing a patient seeking an opioid dosage increase without signs of objective deterioration. Results: The prescription of strong opioids in this study was not always in accordance with current guidelines. When presented with a scenario in which a patient sought to have their opioid dose increased, some physicians reported negative feelings, such as either pressure (25%), helplessness (25%), anger (23%) or a combination. The risk of non-guideline-compliant prescribing behavior using the example of ultrafast-acting fentanyl for CNCP was increased when negative emotions were present (OR: 1.7; 95%-CI: 1.2−2.6; p = 0.007) or when sublingual buprenorphine was prescribed (OR: 15.4; 95%-CI: 10.1−23.3; p < 0.001). Conclusions: Physicians' emotional self-awareness represents the first step to identify such direct reactions to patient requests and to ensure a responsible, guideline-based opioid prescription approach for the long-term well-being of the patient.

Validation of Cardiovascular Risk Prediction by the Arriba Instrument.

BACKGROUND: It is recommended in cardiovascular prevention guidelines that treatment should be based on overall cardiovascular risk. The arriba instrument has been widely used for this purpose in Germany. The aim of this study is to validate risk prediction by arriba with the aid of morbidity and mortality data from the population- based Study of Health in Pomerania. METHODS: In a longitudinal analysis, the arriba instrument was used to calculate the 10-year overall cardiovascular risk at baseline for subjects who had not sustained any prior cardiovascular event. Cardiovascular event rates were determined from follow-up data, and discrimination and calibration measures for the risk determination algorithm were calculated. RESULTS: Data from 1973 subjects (mean age 51 ± 13 years, 48% men) were included in the analysis. After a median follow-up of 10.9 years, cardiovascular events had occurred in 196 subjects, or 9.8%. The ratio of predicted to observed event rate was 0.8 (95% confidence interval: [0.5; 1.1]), 1.3 [1.0; 1.8], and 1.1 [0.8; 1.4] for subjects at low, intermediate, and high cardiovascular risk, respectively. Arriba underestimated cardiovascular event rates in women and overestimated them in persons aged 30-44 and 45-59. The area under curve was 0.84 [95% CI 0.81; 0.86]. CONCLUSION: The discrimination scores of the arriba instrument resemble those of SCORE-Germany and PROCAM, but a better adjustment to the target population would be desirable. The results support the recommendation of the German Guideline for Cardiovascular Risk Counseling in General Practice for the use of the arriba instrument. An unresolved problem is the failure to consider intervention effects, resulting in an overall mild overestimation of risk.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Regional variation in coronary angiography rates: the association with supply factors and the role of indication: a spatial analysis.

BACKGROUND: Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA. METHODS: We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level. RESULTS: Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI. CONCLUSIONS: The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.