Care with allergen immunotherapy for allergic respiratory diseases in Germany-Predictors and deficits.

BACKGROUND: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. METHODS: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. RESULTS: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. CONCLUSIONS: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits.

Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB™): 2-year results from the GABI-R-registry.

BACKGROUND: Numerous studies have reported clinical endpoints following coronary revascularization using bioresorbable vascular scaffolds (BVS), while information about the impact on health-related quality of life is sparse. In this analysis of the German-Austrian ABSORB RegIstRy, the 2 year results concerning quality of life development in a large cohort of patients treated with BVS were reported. METHODS: Data were collected at baseline as well as 30 days, 6 and 24 months after coronary revascularization using BVS. The EQ-5D score, EQ visual analogue scale (VAS) and Seattle Angina Questionnaire (SAQ) were determined for each time point. Patients were categorized according to the indication for coronary revascularization [acute coronary syndrome (ACS), stable angina pectoris (SAP), silent myocardial ischemia (SMI), or other]. Binary logistic regression analysis was performed to determine factors that predict above-average scores two years after implantation. RESULTS: Data from 1317 patients in 88 centres were included. Reasons for revascularization were: ACS (n = 643), SAP (n = 443), SMI (n = 52), and other (n = 179). Mean EQ-5D was significantly increased after six months, while a value comparable to baseline was found two years after implantation. EQ VAS and four of five dimensions of SAQ were significantly improved over baseline at all follow-up surveys. Particularly strong improvements were seen in SAQ scores angina frequency and quality of life. Binary regressions showed different statistically significant predictors in the respective models. CONCLUSIONS: Following coronary revascularization with BVS strong decrease in self-reported angina frequency and increase of self-reported quality of life were observed with continuous improvements over two years of follow-up. Trial registration ClinicalTrials.gov Identifier: NCT02066623.

A complex intervention to promote prevention of delirium in older adults by targeting caregiver's participation during and after hospital discharge - study protocol of the TRAnsport and DElirium in older people (TRADE) project.

BACKGROUND: Among potentially modifiable risk factors for delirium, transfers between wards, hospitals and other facilities have been mentioned with low evidence. TRADE (TRAnsport and DElirium in older people) was set up to investigate i) the impact of transfer and/or discharge on the onset of delirium in older adults and ii) feasibility and acceptance of a developed complex intervention targeting caregiver's participation during and after hospital discharge or transfer on cognition and the onset of delirium in older adults. METHODS: The study is designed according to the guidelines of the UK Medical Research Council (MRC) for development and evaluation of complex interventions and comprises two steps: development and feasibility/piloting. The development phase includes i) a multicenter observational prospective cohort study to assess delirium incidence and cognitive decline associated with transfer and discharge, ii) a systematic review of the literature, iii) stakeholder focus group interviews and iv) an expert workshop followed by a Delphi survey. Based on this information, a complex intervention to better and systematically involve family caregivers in discharge and transport was developed. The intervention will be tested in a pilot study using a stepped wedge design with a detailed process and health economic evaluation. The study is conducted at four acute care hospitals in southwest Germany. Primary endpoints are the delirium incidence and cognitive function. Secondary endpoints include prevalence of caregiver companionship, functional decline, cost and cost effectiveness, quality of discharge management and quality of admission management in admitting hospitals or nursing homes. Data will be collected prior to discharge as well as after 3, 7 and 90 days. DISCUSSION: TRADE will help to evaluate transfer and discharge as a possible risk factor for delirium. In addition, TRADE evaluates the impact and modifiability of caregiver's participation during patient's transfer or discharge on delirium incidence and cognitive decline providing the foundation for a confirmatory implementation study. TRIAL REGISTRATION: DRKS (Deutsches Register für klinische Studien) DRKS00017828 . Registered on 17th September 2019. Retrospectively registered.

Clinical and Economic Benefits of Upper Airway Stimulation for Obstructive Sleep Apnea in a European Setting.

BACKGROUND: Upper airway stimulation (UAS) is a treatment approach for patients with moderate-to-severe obstructive sleep apnea who cannot adhere to continuous positive airway pressure therapy. OBJECTIVE: The objective was to evaluate added patient benefit and cost-effectiveness of UAS in the German health care system. METHODS: We used a decision-analytic Markov model to project major adverse cardiovascular or cerebrovascular events (myocardial infarction [MI] or stroke), motor vehicle collision (MVC), mortality, quality-adjusted life years (QALYs), and costs. The assumed reduction in the apnea-hypopnea index with UAS compared to no treatment is based on German real-world data. Other input data were derived from the literature, public statistics, and multivariate regression. Cost-effectiveness was evaluated in Euros per QALY gained, both discounted at 3%. RESULTS: UAS was projected to reduce event risks (10-year relative risk for stroke, MI, cardiovascular death, and MVC: 0.76, 0.64, 0.65, and 0.34, respectively), and to increase survival by 1.27 years. While the UAS strategy incurred an additional 1.02 QALYs within the patient lifetime, there were also additional costs of EUR 45,196, resulting in an incremental cost-effectiveness ratio of EUR 44,446 per QALY gained. -Conclusions: In the present model-based analysis, UAS therapy provides meaningful benefit to patient-relevant endpoints and is a cost-effective therapy in the German setting.

[Barriers to Accessing HIV Testing Services - A Systematic Literature Review]. / Zugangsschwellen zu HIV-Test-Angeboten ­ Eine systematische Literaturanalyse.

OBJECTIVE: In Germany there are 3,100 new HIV infections per year (2016), mainly homosexual men and intravenous drug users. According to experts from Robert Koch Institute, about 30 % of people with HIV are diagnosed late, well past the optimal moment to start the antiretroviral therapy. The high rate of late presenters seems to be a strong argument for an intensification of voluntary counseling and testing services. The main objective of this literature analysis was to describe the barriers to HIV testing. METHODS: A systematic literature search was done to evaluate current knowledge on theory and practice regarding barriers that keep vulnerable groups from getting tested. The analysis includes all publications between 2000 and 2014 from western industrial states. RESULTS: 132 publications have been included in a full text analysis. Most of these publications present the result of surveys of clients attending counseling and testing services. Hence, we have a clear idea of the elements that are relevant for clients when they decide whether or where to get tested for HIV. First, the individual risk perception influences the decision on getting tested or not. The risk perception can be influenced through public relations and outreach services. All processes within the counseling and testing service should be adapted to assure confidentiality and anonymity. In addition, clients want to have counseling that is accepting and free of prejudices. These elements are therefore important since HIV is often associated with getting stigmatized. Similar concerns regarding stigmatization occur if clie nts have sexual preferences that can be considered as deviant. The clients' fear of stigmatization, judgment and social exclusion requires a high sensitivity for the situation of the clients and acceptance of their lifestyle. CONCLUSION: We have a clear insight into how clients decide on getting tested or not. The factor with the greatest influence in the decision-making process is the individual risk perception and anxiety regarding stigmatization. Stigmatization is suspected as a societal reaction to deviant sexual behavior or to being infected with HIV. Public relations should inform about risk factors and risk perception as well as on confidentiality and anonymity of the service. The use of social media and social networks is highly recommended. New approaches such as home testing could eliminate the concerns regarding confidentiality and anonymity.

Vaccinating the German Population Aged 60 Years and Over with a Quadrivalent High-Dose Inactivated Influenza Vaccine Compared to Standard-Dose Vaccines: A Transmission and Budget Impact Model.

BACKGROUND AND OBJECTIVE: In Germany, influenza vaccination is mainly advised for persons aged 60 years and over and individuals with health risks. Since 2021, an inactivated, quadrivalent high-dose influenza vaccine (IIV4-HD) has been recommended for persons aged 60 years and over. The aim of this study was to calculate the impact of vaccinating the German population aged 60 years and over with IIV4-HD compared to standard-dose influenza vaccines (IIV4-SD) with regard to health outcomes and costs. METHODS: An age-stratified deterministic compartment model was built to simulate the course of influenza infection for the German population in the season 2019/20. Probabilities for health outcomes and cost data were searched from the literature and were used to compare the influenza-related health and economic effects for different scenarios. Perspectives were those of the statutory health insurance and the society. Deterministic sensitivity analyses were conducted. RESULTS: From the statutory health insurance perspective, vaccinating the German population aged 60 years and over with IIV4-HD would have prevented 277,026 infections (- 1.1%) with an increase of overall direct costs of €224 million (+ 40.1%) compared with IIV4-SD. A separate analysis showed that increased vaccination of 75% (World Health Organization recommendation for older age groups) in persons aged 60 years and over using IIV4-SD only would prevent 1,289,648 infections (- 5.1%) and would save costs from a statutory health insurance perspective of €103 million (- 13.2%) compared with IIV4-HD at actual vaccination rates. CONCLUSIONS: The modeling approach offers important insights into the epidemiological and budgetary impact of different vaccination scenarios. Achieving a higher vaccination coverage with IIV4-SD in persons aged 60 years and over would result in lower costs and fewer influenza infections compared with the scenario with IIV4-HD and actual vaccination rates.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study.

BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective. METHODS:  The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs. RESULTS:  The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of €3072 (SD: 3485), of which €699 (SD: 743) could be assigned to allergic respiratory diseases. CONCLUSIONS:  Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low.

How effective and how expensive are interventions to reduce sedentary behavior? An umbrella review and meta-analysis.

A reduction in sedentary behavior (SB) can contribute to the prevention of chronic diseases. This is the first umbrella review that summarizes the effectiveness and monetary costs of different types of interventions to reduce SB across all age groups and populations in different settings. We comprehensively searched seven databases for systematic reviews and meta-analyses and conducted an umbrella review of the effects of interventions to reduce SB. Additionally, we performed a meta-analysis of primary studies included in the umbrella review. Furthermore, we analyzed health economic aspects of interventions to reduce SB. We included 40 systematic reviews in our umbrella review, with 136 primary studies suitable for further meta-analyses. We found that interventions targeting the physical environment reduce SB most effectively in the majority of populations and settings. Workplace interventions reduced SB by -89.83 min/day (95% CI -124.58 to -55.09; p ≤ 0.0001). Twenty-two of 169 primary studies (13.0%) contained health economic information. The intervention costs per participant ranged from €0 to €3587. Our findings demonstrate that physical environment interventions most effectively reduce SB in a majority of populations and settings. Health economic information was reported in few studies and was mostly restricted to acquisition costs.

Using the Lifeworld Approach to Improve HIV Testing.

Major guidelines for HIV recommend that testing should be provided in a way that is adapted to the lifeworld of groups at risk. However, precise definitions as to what adaption to the lifeworld means are missing. Therefore, this research project evaluated how the lifeworld approach can be operationalized in regard to HIV testing and how voluntary counseling and testing services can use this approach to improve efficacy. A survey for VCT providers in Germany showed a limited number of factors influencing the adaption to the lifeworld of groups at risk. The opening hours, the number of languages used in public relations, and the comfort of the waiting zone are important for all clients. For men who have sex with men, information material for use in social networks and peer volunteers are relevant. Intravenous drug users are concerned with participation, (low) costs, and counseling. For migrants, continuing staff training and anonymity are important.

Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults-study protocol for a stepped-wedge cluster randomized trial (PAWEL Study).

BACKGROUND: Postoperative delirium is a common disorder in older adults that is associated with higher morbidity and mortality, prolonged cognitive impairment, development of dementia, higher institutionalization rates, and rising healthcare costs. The probability of delirium after surgery increases with patients' age, with pre-existing cognitive impairment, and with comorbidities, and its diagnosis and treatment is dependent on the knowledge of diagnostic criteria, risk factors, and treatment options of the medical staff. In this study, we will investigate whether a cross-sectoral and multimodal intervention for preventing delirium can reduce the prevalence of delirium and postoperative cognitive decline (POCD) in patients older than 70 years undergoing elective surgery. Additionally, we will analyze whether the intervention is cost-effective. METHODS: The study will be conducted at five medical centers (with two or three surgical departments each) in the southwest of Germany. The study employs a stepped-wedge design with cluster randomization of the medical centers. Measurements are performed at six consecutive points: preadmission, preoperative, and postoperative with daily delirium screening up to day 7 and POCD evaluations at 2, 6, and 12 months after surgery. Recruitment goals are to enroll 1500 patients older than 70 years undergoing elective operative procedures (cardiac, thoracic, vascular, proximal big joints and spine, genitourinary, gastrointestinal, and general elective surgery procedures). DISCUSSION: Results of the trial should form the basis of future standards for preventing delirium and POCD in surgical wards. Key aims are the improvement of patient safety and quality of life, as well as the reduction of the long-term risk of conversion to dementia. Furthermore, from an economic perspective, we expect benefits and decreased costs for hospitals, patients, and healthcare insurances. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013311 . Registered on 10 November 2017.

Impact of increasing treatment rates on cost-effectiveness of subcutaneous immunotherapy (SCIT) in respiratory allergy: a decision analytic modelling approach.

BACKGROUND: Specific immunotherapy is the only causal treatment in respiratory allergy. Due to high treatment cost and possible severe side effects subcutaneous immunotherapy (SCIT) is not indicated in all patients. Nevertheless, reported treatment rates seem to be low. This study aims to analyze the effects of increasing treatment rates of SCIT in respiratory allergy in terms of costs and quality-adjusted life years (QALYs). METHODS: A state-transition Markov model simulates the course of disease of patients with allergic rhinitis, allergic asthma and both diseases over 10 years including a symptom-free state and death. Treatment comprises symptomatic pharmacotherapy alone or combined with SCIT. The model compares two strategies of increased and status quo treatment rates. Transition probabilities are based on routine data. Costs are calculated from the societal perspective applying German unit costs to literature-derived resource consumption. QALYs are determined by translating the mean change in non-preference-based quality of life scores to a change in utility. Key parameters are subjected to deterministic sensitivity analyses. RESULTS: Increasing treatment rates is a cost-effective strategy with an incremental cost-effectiveness ratio (ICER) of 3484€/QALY compared to the status quo. The most influential parameters are SCIT discontinuation rates, treatment effects on the transition probabilities and cost of SCIT. Across all parameter variations, the best case leads to dominance of increased treatment rates while the worst case ICER is 34,315€/QALY. Excluding indirect cost leads to a twofold increase in the ICER. CONCLUSIONS: Measures to increase SCIT initiation rates should be implemented and also address improving adherence.