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Introduction Randomised controlled trials (RCTs) have shown a positive effect of early integration of palliative care (EIPC) in various advanced cancer entities regarding patients’ quality of life (QoL), survival, mood, caregiver burden and reduction of aggressiveness of treatment near the end of life. However, RCTs investigating the positive effect of EIPC for patients suffering from glioblastoma multiforme (GBM) are lacking. After modelling work identifying the specific needs of GBM patients and their caregivers, the aim of this study is to investigate the impact of EIPC in this particular patient group. Methods and analysis The recruitment period of this multicenter RCT started in May 2019. GBM patients (n=214) and their caregivers will be randomly assigned to either the intervention group (receiving proactive EIPC on a monthly basis) or the control group (receiving treatment according to international standards and additional, regular assessment of QoL (‘optimised’ standard care)). The primary outcome is QoL assessed by subscales of the Functional Assessment of Cancer Therapy for brain tumour (FACT-Br) from baseline to 6 months of treatment. Secondary outcomes are changes in QoL after 12 (end of intervention), 18 and 24 months (end of follow-up), the full FACT-Br scale, patients’ palliative care needs, depression/anxiety, cognitive impairment, caregiver burden, healthcare use, cost-effectiveness and overall survival. Ethics and dissemination The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the local ethics committees of the University Clinics of Cologne, Aachen, Bonn, Freiburg and Munich (LMU). Results of the trial will be submitted for publication in a peer-reviewed, open access journal and disseminated through presentations at conferences. [ABSTRACT FROM AUTHOR]

Background and purpose: The German Institute for Quality and Efficiency in Health Care (IQWiG) previously tested two preference elicitation methods in pilot projects and regarded them as generally feasible for prioritizing outcome-specific results of benefit assessment. The present study aimed to investigate the feasibility of completing a discrete choice experiment (DCE) within 3 months and to determine the relative importance of attributes of periodontal disease and its treatment.Patients and methods: This preference elicitation was conducted alongside the IQWiG benefit assessment of systematic treatments of periodontal diseases. Attributes were defined based on the benefit assessment, literature review, and patients' and periodontologists' interviews. The DCE survey was completed by patients with a history of periodontal disease. Preferences were elicited for the attributes "tooth loss within next 10 years", "own costs for treatment, follow-up visits, re-treatment", "complaints and symptoms", and "frequency of follow-up visits". Patients completed a self-administered questionnaire including 12 choice tasks. Data were analyzed using a random parameters logit model. The relative attribute importance was calculated based on level ranges.Results: Within 3 months, survey development, data collection among 267 patients, data analysis, and provision of a study report could be completed. The analysis showed that tooth loss (score 0.73) was the most important attribute in patients' decisions, followed by complaints and symptoms (0.22), frequency of follow-up visits (0.02), and costs (0.03) (relative importance scores summing up to 1).Conclusion: A preference analysis performing a DCE can be generally feasible within 3 months; however, a good research infrastructure and access to patients is required. Outcomes used in benefit assessments might need to be adapted to be used in preference analyses. [ABSTRACT FROM AUTHOR]

The cost-effectiveness of rituximab in combination with fludarabine/cyclophosphamide (R-FC) for the first line treatment of chronic lymphocytic leukemia (CLL) was evaluated. Based on long-term clinical data (follow-up of 5.9 years) from the CLL8-trial, a Markov-model with three health states (Free from disease progression, Progressive disease, Death) was used to evaluate the cost per quality-adjusted life-year (QALY) and cost per life years gained (LYG) of R-FC from the perspective of the German statutory health insurance (SHI). The addition of rituximab to FC chemotherapy results in a gain of 1.1 quality-adjusted life-years. The incremental cost-effectiveness ratio (ICER) of R-FC compared with FC was €17 979 per QALY (€15 773 per LYG). Results were robust in deterministic and probabilistic sensitivity analyses. From the German SHI perspective, rituximab in combination with FC chemotherapy represents good value for first-line treatment of patients with CLL and compares favorably with chemotherapy alone. [ABSTRACT FROM AUTHOR]

Background: Acute otitis media (AOM) is one of the main reasons for medical consultation and antibiotic use during childhood. Although 80% of AOM cases are self-limiting, antibiotic prescription is still high, either for physician- or for parent-related factors. This study aims to identify parental knowledge about, beliefs and attitudes towards, and experiences with AOM and its therapy and thus to gain insights into parents' perspectives within the German health care system.Methods: An exploratory survey was conducted among German-speaking parents of children aged 2 to 7 years who sent their children to a childcare facility. Childcare facilities were recruited by convenience sampling in different urban and rural sites in Germany, and all parents with children at those facilities were invited to participate. Data were evaluated using descriptive statistical analyses.Results: One-hundred-thirty-eight parents participated. Of those, 75.4% (n = 104) were AOM-experienced and 75.4% (n = 104) had two or more children. Sixty-six percent generally agree that bacteria cause AOM. 20.2% generally agree that viruses cause AOM. 30.5% do not generally agree that viruses cause AOM. Eight percent generally agree that AOM resolves spontaneously, whereas 53.6% do not generally agree. 92.5% generally (45.7%) and partly (42.8%) agree that AOM needs antibiotic treatment. With respect to antibiotic effects, 56.6% generally agree that antibiotics rapidly relieve earache. 60.1% generally agree that antibiotics affect the gastrointestinal tract and 77.5% generally agree that antibiotics possibly become ineffective after frequent use. About 40% generally support and about 40% generally reject a "wait-and-see" strategy for AOM treatment. Parental-reported experiences reveal that antibiotics are by far more often prescribed (70.2%) than actively requested by parents (26.9%).Conclusions: Parental views on AOM, its therapy, and antibiotic effects reveal uncertainties especially with respect to causes, the natural course of the disease and antibiotic effects on AOM. These results indicate that more evidence-based information is needed if parents' health literacy in the treatment of children with AOM is to be enhanced. The discrepancy between reported parental requests for antibiotics and reported actual prescriptions contradicts the hypothesis of high parental influence on antibiotic use in AOM. [ABSTRACT FROM AUTHOR]

Costs of male osteoporosis may have increased due to population aging and change of treatment patterns. This cost-of-illness study provides a current estimate of the economic burden of male osteoporosis in Germany. Routine claims data from six German sickness funds were analyzed and extrapolated to the German statutory health insurance (SHI). For men above the age of 50 with at least one ICD-10 osteoporosis-related diagnosis or osteoporosis-related fracture in 2010, direct costs related to osteoporosis were considered based on a payer's perspective. Total direct costs attributable to osteoporosis amounted to €728 million in 2010. The majority of these costs (71%) resulted from inpatient treatment due to fractures. Patients aged 75 and older caused approximately 63% of costs. Male osteoporosis represents a non-negligible economic burden for the German health care system. Targeted prevention and promotion measures should be offered both to men and women. [ABSTRACT FROM AUTHOR]

Objective: The goal of this study was to investigate gender-specific differences in prevalence, healthcare costs, and treatment patterns in the German Statutory Health Insurance (SHI). Methods: The study analyzed administrative claims data of over 26 million insured with respect to prevalence and cost of illness of six chronic diseases. Insured were identified using the ATC code for medication prescription and ICD-9 code for diagnosis. The influences of gender, age, and comorbidity on cost differences were analyzed via multivariate regression analysis. Results: Adjusted for age and comorbidity, gender had a significant influence on both hospital and medication spending. Hospital costs on average were 17.1% (95% CI 14.1; 20.2) higher for men compared with women. Medication spending for men exceeded that for women on average by 13.8% (95% CI 10.9; 16.7). The diagnoses with the highest prevalence were hypertension and heart failure. Women had a higher prevalence of diabetes, coronary artery disease (CAD), heart failure, and hypertension. Medication costs were higher for men in three of five diagnoses and comparable for two diagnoses (diabetes and asthma). Women received more medication prescriptions than men, but on average prescriptions for men were 14%–26% more expensive than prescriptions for women. Regarding treatment patterns men were treated with different drug classes in cardiovascular disease (CVD) compared with women. Total medication spending stratified by diagnosis was highest for diabetes. Conclusions: Gender differences for costs and prescribing patterns for chronic diseases vary disease specifically, but generally men had higher inpatient costs and more expensive medication prescriptions, whereas women had higher numbers of prescriptions. [ABSTRACT FROM AUTHOR]

Objective Quantification of the economic burden for society and the German Statutory Pension Insurance due to early retirement in schizophrenia. Methods Based on empirical data of the German Statutory Pension Insurance, productivity losses were calculated using the human capital approach. Results The total expenditures of the German Statutory Pension Insurance due to pension payments for schizophrenic insurants amounted to € 450 million. Total indirect costs due to morbidity and mortality were estimated at € 2,3 million. Average indirect costs per patient ranged between € 17 000 - 28 000, depending on rates for discounting and inflation. Conclusion Regarding substantial economic consequences, preventive measures and therapeutic procedures should aim to prevent reduction in earning capacity and to promote occupational reintegration of schizophrenic patients., (© Georg Thieme Verlag KG Stuttgart · New York.)