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Allergen immunotherapy (AIT), when continued for 3 years, is the only disease-modifying treatment for AR and asthma. Adherence is a key to ensure effectiveness, and poor adherence is a contraindication for AIT. The objective of this study was to evaluate real-world adherence to AIT with subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) preparations in patients allergic to grass or tree pollen. The impact of AIT on the consumption of asthma and rhinitis medication was also analyzed. In this retrospective cohort analysis of a German longitudinal prescription database, the adherence of a grass and tree pollen allergoid was examined and compared to two sublingual AIT tablets/drops. Patients receiving grass or tree allergen-specific immunotherapy prescriptions were compared with non-AIT patients receiving symptomatic allergic rhinitis (AR) and asthma prescriptions. The study endpoints included therapy adherence, AR progression, and asthma progression. Multivariate regression analyses were used to estimate the effects of SCIT or SLIT, adjusting for variables related to demographics and prescriptions. SCIT adherence was 60.1-61.8% at 2 years and 35.0-37.5% at 3 years for the two allergens. SLIT adherence was distinctly lower (29.5-36.5% and 9.6-18.2%, respectively). Adherence in children was higher compared to adolescents or adults. All products were highly efficacious at reducing symptomatic AR medication consumption. SCIT also reduced asthma medication use for both allergens, whereas for SLIT these results were significant only for grasses but not trees. Subcutaneous AIT in a real-world setting achieved significantly higher adherence rates compared to sublingual administration. SCIT reduced the use of rhinitis and asthma medication significantly for both allergens, while SLIT reduced the use of rhinitis medication for both allergens and the use of asthma medication for grasses only.

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

Background Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104–183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. Methods ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. Conclusions ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. Trial registration ClinicalTrials.gov Identifier: NCT02943993 .

The management of patients with atrial fibrillation (AF) has rapidly changed with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs) and changes in the use of rhythm control therapy. The prevention of thromboembolic events European Registry in Atrial Fibrillation Prolongation Registry (PREFER Prolongation) enrolled consecutive patients with AF on NOACs between 2014 and 2016 in a multicentre, prospective, observational study with one-year follow-up, focusing on the time of introduction of NOACs. Overall, 3783 patients were enrolled, with follow-up information available in 3223 (85%). Mean age was 72.2 ± 9.4 years, 40% were women, mean CHA2DS2VASc score was 3.4 ± 1.6, and 2587 (88.6%) had a CHA2DS2VASc score ≥ 2. Rivaroxaban was used in half of patients, and dabigatran and apixaban were used in about a quarter of patients each; edoxaban was not available for use in Europe at the time. Major cardiovascular event rate was low: serious events occurred in 74 patients (84 events, 2%), including 24 strokes (1%), 62 major bleeds (2%), of which 30 were life-threatening (1%) and 3 intracranial (0.1%), and 28 acute coronary syndromes (1%). Mortality was 2%. Antiarrhythmic drugs were used in about 50% of patients, catheter ablation in 5%. Adverse events were low in this contemporary European cohort of unselected AF patients treated with NOACs already at the time of their first introduction, despite high thromboembolic risk.

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 6% of people over 65 years, and carries a 4.5% average annual stroke risk, which can be reduced by appropriate anticoagulation. A multi-centre observational study, Management and Outcomes in the Care of Atrial fibrillation in Germany (MOCA) was conducted to evaluate the current anticoagulation treatment pattern in patients with AF in Germany. Patients with AF were recruited from December 2003 to June 2004 in physician practices. Clinical data including International Normalised Ratio (INR) values and anticoagulation strategy were obtained from the physician chart and the patient follow-up, documenting hospitalisations, medications, and complications, was conducted at three and six months. Main outcome measures included anticoagulation methods, practice guidelines adherence and time within recommended anticoagulation range. 361 patients with AF (mean age 71+/-9, 61% male) were recruited in 45 physician practices. 90% of all patients had been treated with Vitamin K-Antagonists (VKA) at some time since AF-diagnosis, 88% were still treated. 10% of patients received aspirin as their anticoagulation therapy. Monitoring occurred at least once a month in over 70% of patients. Monitored INR values were 56% of the time within, 14% below and 30% over the recommended target range. A gap of 40% existed between the guideline recommendations and actual practice. Younger patients (<60 years of age) with no documented risk factors for stroke were over-treated with VKAs and patients older than 75 years without contraindications for anticoagulation were under-treated. This study presents 'real-life' data in treating patients with AF in Germany and identifies the potential to advance the quality of care with respect to anticoagulation.

Although total knee arthroplasty (TKA) procedures are increasing, patient satisfaction is still inferior compared to total hip arthroplasty. The ATTUNE Knee System was designed to reduce pain and improve function, leading to greater patient satisfaction and decreased resource utilization in TKA. The objective of this study was to compare length of stay (LOS) of TKA with ATTUNE knee versus LCS knee implants. A retrospective chart review analysis in a German center was conducted between 2008 and 2016. All patients without prior ipsilateral knee operation, treated with a cemented LCS or ATTUNE knee were included. Endpoints captured included gender, age, availability of home support, prior contralateral TKA, ASA grade and LOS. Statistical analyses included chi-squared test for differences in patient demographics and Welch two-sample -test for difference in LOS. Mean LOS in the ATTUNE Knee group (N=85) was 8.3 days (SD: 1.79) compared to 10.4 days (SD: 1.91) in the LCS knee group (N=85). No significant differences in gender, age, availability of home support, prior contralateral TKA, or ASA grade between both cohorts were observed. The 2.1 days reduction was statistically significant ( <0.001; 95%CI: 2.7-1.6). A sensitivity analysis outlined the impact of the study duration: even when assuming that 1.3 days reduction resulted from the observed national LOS decrease, the remaining 0.8 reduction in days LOS reduction was still significant ( <0.01). When comparing two cohorts with similar sociodemographic and medical factors, LOS of ATTUNE knee patients was 2.1 days shorter than patients treated with the LCS knee.

[This corrects the article DOI: 10.1186/s12959-018-0163-7.].

Restless legs syndrome (RLS) is a common and often underestimated neurological disorder, with a prevalence ranging from approximately 2.5% to 10% in Western industrialized countries. The aim of the present study was to summarize the research findings on the human and economic costs associated with RLS in populations without any co-morbidities or potentially confounding health conditions. A further objective was to identify studies on the cost effectiveness of RLS treatments. A systematic literature search was performed. Two researchers independently assessed the relevance of each publication. Studies published before August 2008 were included if they assessed quality of life in patients suffering from RLS, determined total or patient-related costs attributable to RLS, and/or evaluated the cost effectiveness of treatment options for RLS. A total of 725 references were identified, including 100 full-text articles. Fifteen of these publications met all of the selection criteria and were included in the present review. Seven abstracts that focused on the economic burden of RLS and/or the cost effectiveness of different treatment strategies in RLS patients were also included. RLS was associated, in the included studies, with reductions in quality of life similar to those seen in patients with other chronic conditions. The cost-of-illness studies were heterogeneous but indicated that RLS was associated with a substantial economic burden, resulting in high direct and indirect costs to society. Although effective and cost-effective treatments appear to be available, further research is warranted, especially regarding the economic burden of RLS and the cost effectiveness of available treatment options.

Objective To determine the cost-effectiveness of adding eptifibatide to the standard treatment for selected high-risk patients undergoing coronary stenting in Germany. Furthermore, to investigate the impact of several extrapolation methods on the results. Methods A Markov model was developed to reflect the clinical events in this specific patient population, including target vessel revascularization, myocardial infarction, and death. To extrapolate clinical data beyond 1 year, a linear, an exponential, and a Weibull survival curves were estimated. Patient characteristics and transition probabilities were derived from a high-risk subgroup of the ESPRIT trial; patient-level utility data came from a published Dutch study. Costs were calculated from a hospital and from a third-party payer perspective. Results For both perspectives, the additional treatment with eptifibatide is the considered dominant alternative. The incremental net benefit of its use exceeds €10,000 for both perspectives. Results proved stable in probabilistic sensitivity analysis as well as under the different extrapolation scenarios. Conclusions Eptifibatide is likely to be dominant strategy with 77.7 and 96.7% of the simulations leading to QALYs gained and generating cost savings from both the hospital and the third-party payer perspective. Eptifibatide offsets its additional treatment costs by avoiding costly repeat procedures and leads to positive QALY gains by preventing cardiovascular events lending themselves to transient or permanent lower quality of life. The method used to extrapolate the short-term risks did not impact on results, mainly due to similar clinical risk profiles between the two treatment groups in the long term.

Background Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context. Objective The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/split analyses approach, some statistical approaches and modelling approaches. Conclusion A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods.