[White Paper - Improving the care of patients with impairments following sepsis and infections]. / White Paper ­ Verbesserung der Versorgungs- und Behandlungsangebote für Menschen mit Sepsis- und Infektionsfolgen.

Hundreds of thousands of individuals who experience lasting sequelae after sepsis and infections in Germany do not receive optimal care. In this White Paper we present measures for improvement, which were developed by a multidisciplinary expect panel as part of the SEPFROK project. Improved care rests on four pillars: 1. cross-sectoral assessment of sequelae and a structured discharge and transition management, 2. interdisciplinary rehabilitation and aftercare with structural support, 3. strengthening the specific health literacy of patients and families, and 4. increased research into causes, prevention and treatment of sequelae. To achieve this, appropriate cross-sectoral care structures and legal frameworks must be created.

Healthcare Utilization and Costs in Sepsis Survivors in Germany-Secondary Analysis of a Prospective Cohort Study.

Background: Survivors of sepsis often face long-term sequelae after intensive care treatment. Compared to the period of hospitalization, little is known about the ambulatory healthcare utilization in sepsis patients. The study evaluated healthcare utilization and associated costs of sepsis care including allied health professions after initial hospitalization. Methods: Secondary analysis was performed on data in 210 sepsis patients prospectively enrolled from nine intensive care study centers across Germany. Data was collected via structured surveys among their Primary care (Family-) physicians (PCPs) within the first month after discharge from ICU (baseline) and again at 6, 12 and 24 months after discharge, each relating to the period following the last survey. Costs were assessed by standardized cost unit rates from a health care system's perspective. Changes in healthcare utilization and costs over time were calculated using the Wilcoxon rank-sum test. Results: Of the 210 patients enrolled, 146 (69.5%) patients completed the 24 months follow-up. In total, 109 patients were hospitalized within the first 6 months post-intensive care. Mean total direct costs per patient at 0-6 months were €17,531 (median: €6047), at 7-12 months €9029 (median: €3312), and at 13-24 months €18,703 (median: €12,828). The largest contributor to the total direct costs within the first 6 months was re-hospitalizations (€13,787 (median: €2965). After this first half year, we observed a significant decline in inpatient care costs for re-hospitalizations (p ≤ 0.001). PCPs were visited by more than 95% of patients over 24 months. Conclusions: Sepsis survivors have high health care utilization. Hospital readmissions are frequent and costly. Highest costs and hospitalizations were observed in more than half of patients within the first six months post-intensive care. Among all outpatient care providers, PCPs were consulted most frequently. Clinical impact: Sepsis survivors have a high healthcare utilization and related costs which persist after discharge from hospital. Within outpatient care, possible needs of sepsis survivors as physiotherapy or psychotherapy seem not to be met appropriately. Development of sepsis aftercare programs for early detection and treatment of complications should be prioritized.

Increasing influenza and pneumococcal vaccine uptake in the elderly: study protocol for the multi-methods prospective intervention study Vaccination60.

BACKGROUND: Influenza and pneumococcal vaccination can prevent disease and potentially life-threatening complications like sepsis. Elderly people have an increased risk of severe disease and therefore constitute a major target group for vaccination. To increase vaccination coverage, targeted interventions are needed that take theory-based specific determinants of vaccination behaviour into account. Moreover, message and campaign design should consider specific age-related characteristics (e.g., information processing, media use). The aim of this study is (i) to identify the specific informational and interventional needs of this risk group, (ii) to design and implement a targeted intervention aiming to decrease vaccine hesitancy, increase vaccine uptake and decrease the health and economic burden due to the respective diseases, and (iii) to measure the effect of this evidence-informed intervention on various levels. METHODS: Prospective, multi-methods intervention study targeting individuals aged ≥60 years in a model region in Germany (federal state of Thuringia, 500,000 inhabitants ≥60 years old). The development of the intervention follows theory-based and evidence-informed principles: Data from a cross-sectional representative study provide insights into specific determinants of the target group's vaccination behaviour. Additionally, media use is analysed to identify adequate communication channels for specific subgroups. In pilot studies, the intervention materials are adapted to the specific cognitive requirements of the target group. For development and implementation of the intervention, an interdisciplinary and trans-sectoral approach is used, including psychology, communication science, design, medical science, epidemiology and various public health players. The intervention will be implemented in autumn and winter 2017/18 and 2018/19 and adjusted in between. Evaluation of the intervention includes: awareness, use and recall of intervention materials, effects on changes in determinants of vaccination behaviour, self-reported vaccine uptake, and vaccination coverage in the intervention area (primary outcomes), as well as disease incidences (secondary outcomes) and the economic burden of influenza, pneumonia, invasive pneumococcal disease and sepsis for the healthcare system (tertiary outcomes). DISCUSSION: The data will add to the body of evidence on the effectiveness of evidence-informed vaccination campaign development as well as on the clinical and economic effects of pneumococcal and influenza vaccination. The effect of the intervention will teach valuable lessons about the principles of campaign development and evaluation, and can motivate a subsequent nationwide intervention. TRIAL REGISTRATION: DRKS00012653 . Registered 24.11.2017. Retrospectively registered.

Depression, Comorbidities, and Prescriptions of Antidepressants in a German Network of GPs and Specialists with Subspecialisation in Anthroposophic Medicine: A Longitudinal Observational Study.

Background. Depression is a major reason for counselling in primary care. Our study aims at evaluating pharmacological treatment strategies among physicians specialised in anthroposophic medicine (AM). Methods. From 2004 to 2008, twenty-two German primary care AM-physicians participated in this prospective, multicentre observational study. Multiple logistic regression was used to determine factors associated with a prescription of any antidepressant medication. Results. A total of 2444 patients with depression were included (mean age: 49.1 years (SD: 15.4); 77.3% female). 2645 prescriptions of antidepressants for 833 patients were reported. Phytotherapeutic preparations from Hypericum perforatum were the most frequently prescribed antidepressants over all (44.6% of all antidepressants), followed by amitriptyline (16.1%). The likelihood of receiving an antidepressant medication did not depend on comorbidity after controlling for age, gender, physician specialisation, and type of depression (adjusted OR (AOR) = 1.01; CI: 0.81-1.26). Patients who had cancer were significantly less likely to be prescribed an antidepressant medication than those who had no cancer (AOR = 0.75; CI: 0.57-0.97). Conclusion. This study provides a comprehensive analysis of everyday practice for the treatment of depression in AM -physicians. Further analysis regarding the occurrence of critical combinations is of high interest to health services research.

Prescribing patterns in dementia: a multicentre observational study in a German network of CAM physicians.

BACKGROUND: Dementia is a major and increasing health problem worldwide. This study aims to investigate dementia treatment strategies among physicians specialised in complementary and alternative medicine (CAM) by analysing prescribing patterns and comparing them to current treatment guidelines in Germany. METHODS: Twenty-two primary care physicians in Germany participated in this prospective, multicentre observational study. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients had at least one diagnosis of dementia according to the 10th revision of the International Classification of Diseases during the study period. Multiple logistic regression was used to determine factors associated with a prescription of any anti-dementia drug including Ginkgo biloba. RESULTS: During the 5-year study period (2004-2008), 577 patients with dementia were included (median age: 81 years (IQR: 74-87); 69% female). Dementia was classified as unspecified dementia (57.2%), vascular dementia (25.1%), dementia in Alzheimer's disease (10.4%), and dementia in Parkinson's disease (7.3%). The prevalence of anti-dementia drugs was 25.6%. The phytopharmaceutical Ginkgo biloba was the most frequently prescribed anti-dementia drug overall (67.6% of all) followed by cholinesterase inhibitors (17.6%). The adjusted odds ratio (AOR) for receiving any anti-dementia drug was greater than 1 for neurologists (AOR = 2.34; CI: 1.59-3.47), the diagnosis of Alzheimer's disease (AOR = 3.28; CI: 1.96-5.50), neuroleptic therapy (AOR = 1.87; CI: 1.22-2.88), co-morbidities hypertension (AOR = 2.03; CI: 1.41-2.90), and heart failure (AOR = 4.85; CI: 3.42-6.88). The chance for a prescription of any anti-dementia drug decreased with the diagnosis of vascular dementia (AOR = 0.64; CI: 0.43-0.95) and diabetes mellitus (AOR = 0.55; CI: 0.36-0.86). The prescription of Ginkgo biloba was associated with sex (female: AOR = 0.41; CI: 0.19-0.89), patient age (AOR = 1.06; CI: 1.02-1.10), treatment by a neurologist (AOR = 0.09; CI: 0.03-0.23), and the diagnosis of Alzheimer's disease (AOR = 0.07; CI: 0.04-0.16). CONCLUSIONS: This study provides a comprehensive analysis of everyday practice for treatment of dementia in primary care in physicians with a focus on CAM. The prescribing frequency for anti-dementia drugs is equivalent to those found in other German studies, while the administration of Ginkgo biloba is significantly higher.

Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study.

BACKGROUND: Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. METHODS: Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. RESULTS: In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22). CONCLUSION: The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.

Knowledge transfer for the management of dementia: a cluster randomised trial of blended learning in general practice.

BACKGROUND: The implementation of new medical knowledge into general practice is a complex process. Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QCs) and QCs alone. METHODS: In this cluster-randomised trial with QCs as clusters and general practitioners (GPs) as participants, 389 GPs from 26 QCs in the western part of Germany were invited to participate. Data on the GPs' knowledge were obtained at three points in time by means of a questionnaire survey. Primary outcome was the knowledge gain before and after the interventions. A subgroup analysis of the users of the online modules was performed. RESULTS: 166 GPs were available for analysis and filled out a knowledge test at least two times. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores. CONCLUSION: A blended learning approach was not superior to a QCs approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36550981.

German ambulatory care physicians' perspectives on continuing medical education - a national survey.

INTRODUCTION: This survey aimed to investigate German ambulatory physicians' opinions about mandatory continuing medical education (CME) and CME resources shortly before the introduction of mandatory CME in 2004. METHODS: A structured national telephone survey of general practitioners and specialists was conducted. Main outcome measures were opinions about mandatory CME, preferred CME media, and financial aspects of CME. Data analysis applied Pearson's correlation coefficient for explorative analysis of correlations, analysis of variance for group comparison, and chi(2)-test for investigation of distribution of 2 or more categorical variables. RESULTS: Of the 511 participants, 73% felt that CME supported them in keeping up to date with new medical knowledge, yet only half believed in its ability to minimize medical errors or increase quality of patient care. Traditional ways of learning were preferred. Significant differences in CME behavior were found between primary-care physicians and specialists, the latter using more communicative media. Also, a small group of very skeptical physicians who do not agree with the need for CME in general was identified. Average expenditure for CME was estimated between 500 and 1000 Euros per year. A majority of physicians called for other parties, eg, health insurances or government, to share the financial responsibility for CME. DISCUSSION: Mandatory CME was accepted as a necessity already before the new legislation took effect, with prevailing skepticism at the same time. Future research is needed on how to motivate physicians and especially certain subgroups of physicians to use CME methods shown to be effective in changing clinical behavior.

Evaluation of prescribing patterns in a German network of CAM physicians for the treatment of patients with hypertension: a prospective observational study.

BACKGROUND: The management of hypertension is a key challenge in modern health systems. This study aimed to investigate hypertension treatment strategies among physicians specialized in complementary and alternative medicine (CAM) in Germany by analysing prescribing patterns and comparing these to the current treatment guidelines issued by the German Hypertension Society. METHODS: In this prospective, multicentre observational study, which included 25 primary care physicians specialized in CAM treatment, prescriptions and diagnoses were analysed for each consecutive hypertensive patient using routine electronic data. Data analysis was performed using univariate statistical tests (Chi square test, Cochran-Armitage trend test). Multiple logistic regression was used to determine factors associated with antihypertensive medication. RESULTS: In the year 2005, 1320 patients with 3278 prescriptions were included (mean age = 64.2 years (SD = 14.5), 63.5% women). Most patients were treated with conventional antihypertensive monotherapies (n = 838, 63.5%). Beta-blockers were the most commonly prescribed monotherapy (30.7%), followed by ACE inhibitors (24.0%). Combination treatment usually consisted of two antihypertensive drugs administered either as separate agents or as a coformulation. The most common combination was a diuretic plus an ACE inhibitor (31.2% of dual therapies). Patient gender, age, and comorbidities significantly influenced which treatment was prescribed. 187 patients (14.2%) received one or more CAM remedies, most of which were administered in addition to classic monotherapies (n = 104). Men (OR = 0.66; 95% CI: 0.54-0.80) and patients with diabetes (OR = 0.55; 95% CI: 0.42-0.0.73), hypercholesterolaemia (OR = 0.59; 95% CI: 0.47-0.75), obesity (OR = 0.74; 95% CI: 0.57-0.97), stroke (OR = 0.54; 95% CI: 0.40-0.74), or prior myocardial infarction (OR = 0.37; 95% CI: 0.17-0.81) were less likely to receive CAM treatment. CONCLUSIONS: The large majority of antihypertensive treatments prescribed by CAM physicians in the present study complied with the current German Hypertension Society treatment guidelines. Deviations from the guidelines were observed in one of every seven patients receiving some form of CAM treatment.

Knowledge translation on dementia: a cluster randomized trial to compare a blended learning approach with a "classical" advanced training in GP quality circles.

BACKGROUND: Thus far important findings regarding the dementia syndrome have been implemented into patients' medical care only inadequately. A professional training accounting for both, general practitioners' (GP) needs and learning preferences as well as care-relevant aspects could be a major step towards improving medical care. In the WIDA-study, entitled "Knowledge translation on dementia in general practice" two different training concepts are developed, implemented and evaluated. Both concepts are building on an evidence-based, GP-related dementia guideline and communicate the guideline's essential insights. METHODS/DESIGN: Both development and implementation emphasize a procedure that is well-accepted in practice and, thus, can achieve a high degree of external validity. This is particularly guaranteed through the preparation of training material and the fact that general practitioners' quality circles (QC) are addressed. The evaluation of the two training concepts is carried out by comparing two groups of GPs to which several quality circles have been randomly assigned. The primary outcome is the GPs' knowledge gain. Secondary outcomes are designed to indicate the training's potential effects on the GPs' practical actions. In the first training concept (study arm A) GPs participate in a structured case discussion prepared for by internet-based learning material ("blended-learning" approach). The second training concept (study arm B) relies on frontal medical training in the form of a slide presentation and follow-up discussion ("classical" approach). DISCUSSION: This paper presents the outline of a cluster-randomized trial which has been peer reviewed and support by a national funding organization--Federal Ministry of Education and Research (BMBF)--and is approved by an ethics commission. The data collection has started in August 2006 and the results will be published independently of the study's outcome. TRIAL REGISTRATION: Current Controlled Trials [ISRCTN36550981].

Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.

BACKGROUND: It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria. METHODS: The checklist was developed by listing the most commonly used assessment criteria for clinical studies. Additionally, specific lists for individual applications were included. The categories of biases of internal validity (selection, performance, attrition and detection bias) correspond to structural, treatment-related and observational differences between the test and control groups. Analogously, we have extended these categories to address external validity and model validity, regarding similarity between the study population/conditions and the general population/conditions related to structure, treatment and observation. RESULTS: A checklist is presented, in which the evaluation criteria concerning external validity and model validity are systemized and transformed into a questionnaire format. CONCLUSION: The checklist presented in this article can be applied to both planning and evaluating of clinical studies. We encourage the prospective user to modify the checklists according to the respective application and research question. The higher expenditure needed for the evaluation of clinical studies in systematic reviews is justified, particularly in the light of the influential nature of their conclusions on therapeutic decisions and the creation of clinical guidelines.

[Evidence-based medicine in professional training and education in practice? The integrated evidence-based medicine curriculum at the Medical School at the University of Witten/Herdecke]]. / Evidenzbasierte Medizin: Eingebettet in die Ausbildung--Selbstverständlich in der Praxis? Das integrierte EbM-Curriculum im Modellstudiengang Medizin der Universität Witten/Herdecke.

Applying the principles of evidence-based medicine in clinical practice is becoming more and more important for healthcare professionals in Germany. In this context Witten/Herdecke University has implemented an EbM Curriculum for medical students that is closely related to problem-based learning and clinical rotations within the scope of the six-year medical reform curriculum. Starting with the first semester, students will be able to acquire the necessary skills to search medical databases, to critically review the information retrieved according to EbM standards, to gather evidence for answering diagnostic or therapeutic questions during their clinical education and to ultimately participate in the development of clinical guidelines during their last year.