[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections].

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment

Non-inferiority of sleep position therapy compared to positive airway pressure therapy with regard to daytime sleepiness in patients with mild to moderate position-dependent obstructive sleep apnoea (POSA): study protocol for a multicentre randomised cross-over trial

Abstract Background First-line therapy for patients with clinically relevant obstructive sleep apnoea (OSA) is positive airway pressure therapy (PAP). At least one half of patients with mild to moderate OSA (apnoea-hypopnoea-index (AHI) 5-30/h) have positional OSA (POSA), where apnoea occurs mostly in supine sleep. These patients might benefit from sleep-position therapy (SPT) which should reduce sleeping time spent in a supine position. Until now, it is unclear whether SPT is non-inferior to PAP therapy for symptom relief in these patients. Methods This is a multicentre, non-inferiority, open-label randomised, cross-over clinical trial. Patients with mild to moderate POSA and daytime sleepiness (according to Epworth Sleepiness Scale (ESS) > 10 points) will be randomised with a 1:1 allocation ratio, stratified by centre and AHI, to start with either PAP therapy or SPT and treated for 12 weeks. After a wash-out period of two weeks, they will switch to the other therapy for 12 weeks. The primary outcome is daytime sleepiness measured by the ESS at the end of each treatment phase. Analysis will be done in the intention-to-treat population using a linear mixed-effects model containing the intervention, the phase, the interaction between therapy and phase (including the carry-over effect) and the baseline measurement of the ESS and AHI as fixed effect, and centre and patient as random effects. A one-sided test at significant level of 2.5% will be used to test the non-inferiority of SPT with a non-inferiority margin of 1.35. Based on a sample size calculation with a one-sided one-sample t-test at significant level of 2.5%, assuming a standard deviation of 4, a total of 418 patients should be included to reach 80% power when SPT is only slightly inferior to PAP therapy (difference 0.8 resulting in a delta of 0.55 (1.35-0.8)). Assuming a 5% drop-out rate, 220 patients per sequence should be included. Possible futility stopping is planned at an interim analysis after 300 patients. Discussion The recruitment of patients with mild to moderate POSA is feasible with the planned centres. Both certified interventions (PAP and SPT) are covered by the statutory health insurance companies as part of the trial guideline. Trial registration DRKS00033048 registered 17. June 2024, http://www.drks.de

Health care situation in patients with allergic respiratory diseases with special focus on specific immunotherapy

Summary Background Allergic respiratory diseases have an impact on the performance and quality of life of the patients. The allergen immunotherapy (AIT) is the only causal treatment approach with the chance to positively influence the course of the disease. However, differentiated figures for the treatment of suitable patients in Germany are still missing. Methods The health care situation in Germany is examined with a retrospective, cross-sectional, cohort-based health care analysis based on patient data and routine data from statutory health insurance (SHI). Characteristics are identified that encourage or prevent guideline-based care. In addition, data on quality of life and costs of illness of allergic rhinitis and allergic asthma are collected and evaluated. Results Routine data provide comprehensive and cross-sectoral information about diagnoses and utilization of health care services. In addition, primary data give information on disease severity, treatment history, quality of life, use of alternative treatment methods, and sociodemographic characteristics of the patients. Conclusion Analysis of the care situation with regard to the specific immunotherapy in cases of allergic respiratory diseases (VerSITA) provides a solid basis for future research and for informing decision-makers in order to develop measures to optimize care. </jats:sec

Health care situation in patients with allergic respiratory diseases with special focus on specific immunotherapy

&lt;jats:title&gt;Summary&lt;/jats:title&gt;&lt;jats:sec&gt; &lt;jats:title&gt;Background&lt;/jats:title&gt; &lt;jats:p&gt;Allergic respiratory diseases have an impact on the performance and quality of life of the patients. The allergen immunotherapy (AIT) is the only causal treatment approach with the chance to positively influence the course of the disease. However, differentiated figures for the treatment of suitable patients in Germany are still missing.&lt;/jats:p&gt; &lt;/jats:sec&gt;&lt;jats:sec&gt; &lt;jats:title&gt;Methods&lt;/jats:title&gt; &lt;jats:p&gt;The health care situation in Germany is examined with a retrospective, cross-sectional, cohort-based health care analysis based on patient data and routine data from statutory health insurance (SHI). Characteristics are identified that encourage or prevent guideline-based care. In addition, data on quality of life and costs of illness of allergic rhinitis and allergic asthma are collected and evaluated.&lt;/jats:p&gt; &lt;/jats:sec&gt;&lt;jats:sec&gt; &lt;jats:title&gt;Results&lt;/jats:title&gt; &lt;jats:p&gt;Routine data provide comprehensive and cross-sectoral information about diagnoses and utilization of health care services. In addition, primary data give information on disease severity, treatment history, quality of life, use of alternative treatment methods, and sociodemographic characteristics of the patients.&lt;/jats:p&gt; &lt;/jats:sec&gt;&lt;jats:sec&gt; &lt;jats:title&gt;Conclusion&lt;/jats:title&gt; &lt;jats:p&gt;Analysis of the care situation with regard to the specific immunotherapy in cases of allergic respiratory diseases (VerSITA) provides a solid basis for future research and for informing decision-makers in order to develop measures to optimize care.&lt;/jats:p&gt; &lt;/jats:sec&gt

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

Hillerich V, Valbert F, Neusser S, et al. Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study. European Journal of Health Economics. 2023.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. © 2023. The Author(s)

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

Valbert F, Neusser S, Pfaar O, et al. Care with allergen immunotherapy for allergic respiratory diseases in Germany-Predictors and deficits. Clinical &amp; Experimental Allergy . 2022.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