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Purpose: Human papillomavirus (HPV) is the most common sexually transmitted infection, responsible for multiple HPV-related diseases, including almost all cervical cancers. The highly effective HPV vaccination has been recommended under the German HPV national immunization program (NIP) since 2007 and is reimbursed by health insurances. Vaccination uptake rates, however, remain suboptimal and data on the real-world impact of HPV vaccination in Germany are lacking. This study aims to demonstrate the population-level impact of Germany's NIP on HPV-related anogenital diseases among young women., Methods: Retrospective claims data analysis using a classic impact study design comparing disease prevalence among 28- to 33-year-old women before and after introduction of the HPV-immunization program in Germany. Claims data representing approximately two thirds of German health insurances were used. HPV-related disease outcomes included cervical cancer and high grade precancers (cervical intraepithelial neoplasia (CIN) 2+), anogenital warts, as well as vulvar, vaginal, and anal precancer/cancer., Results: Significant declines were seen for CIN2+, anogenital warts, and vaginal precancer/cancer. Prevalence of CIN2+ declined 51.1% from 0.92% (95% CI = 0.78%, 1.08%) to 0.45% (95% CI = 0.38%, 0.53%). There was a 38.6% decline in anogenital warts prevalence from 0.44% (95% CI = 0.36%, 0.54%) to 0.27% (95% CI = 0.22%, 0.32%) and 75.0% decline in vaginal precancer/cancer prevalence from 0.04% (95% CI = 0.02%, 0.07%) to 0.01% (95% CI = 0.00%, 0.02%)., Conclusion: The German HPV-immunization program has led to significant declines in female anogenital disease among young women in Germany, highlighting the importance of the vaccination. Moreover, the data suggest that increasing vaccination coverage in Germany could further strengthen the public-health impact of its HPV-immunization program., (© 2024. Merck & Co., Inc., Rahway, NJ, USA and its affiliates & Monika Hampl 2024.)

Background: Patients with open fractures often experience complications during their injury. The treatments incur high costs. Interdisciplinary cooperation between different medical disciplines may improve treatment outcomes. Such cooperation has not yet been envisaged in the German health care system., Objective: The aim of the study is to improve the treatment of fractures with open soft tissue damage or postoperative complications in terms of duration and sustainability in a region in northwest Germany. Largely standardized diagnostics and therapy are intended to optimize processes in hospitals. In addition, a reduction in the duration of treatment and treatment costs is to be achieved., Methods: Using a digital platform, physicians from 31 hospitals present patient cases to an interdisciplinary group of experts from the fields of plastic surgery, infectiology, hygiene, and others. The group of experts from the environment of the University Hospital Münster promptly makes a joint treatment recommendation for the individual case. The plan is to examine 3300 patients with open fractures or surgical complications. As consortium partners, there are also 3 statutory health insurance companies. The extent to which the therapy recommendations are effective and contribute to cost reduction in the health care system will be empirically investigated in a stepped-wedge cluster-randomized design. In addition, medical and nonmedical professional groups involved in the project will be asked about their work in the project (in total, 248 clinic employees). The primary outcome is the complication rate of open fractures or the occurrence of postoperative complications. As secondary outcomes, the number of antibiotics administered, limb function, and quality of life will be assessed. The health economic evaluation refers to the costs of health services and absenteeism. For the work-related evaluation, workload, work engagement, work-related resources, readiness for technology, and ergonomic aspects of the new telemedical technology will be collected. In addition, clinic employees will give their assessments of the success of the project in a structured telephone interview based on scaled and open-ended questions., Results: The project started in June 2022; data collection started in April 2023. As of mid-June 2024, data from 425 patients had been included. In total, 146 members of staff had taken part in the questionnaire survey and 15 had taken part in the interviews., Conclusions: Standardized treatment pathways in the standard care of patients with open fractures and postoperative infections will be established to reduce complications, improve chances of recovery, and reduce costs. Unnecessary and redundant treatment steps will be avoided through standardized diagnostics and therapy. The interdisciplinary treatment perspective allows for a more individualized therapy. In the medium term, outpatient or inpatient treatment centers specialized in the patient group could be set up where the new diagnostic and therapeutic pathways could be competently applied., Trial Registration: German Clinical Trials Register DRKS00031308; https://drks.de/search/de/trial/DRKS00031308., International Registered Report Identifier (irrid): DERR1-10.2196/57820., (©Steffen Rosslenbroich, Marion Laumann, Joachim Hasebrook, Sibyll Rodde, John Grosser, Wolfgang Greiner, Tobias Hirsch, Stefan Windrich, Michael J Raschke. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.09.2024.)

Background: Anxiety and depression are the most prevalent psychiatric diseases in the peripartum period. They can lead to relevant health consequences for mother and child as well as increased health care resource utilization (HCRU) and related costs. Due to the promising results of mindfulness-based interventions (MBI) and digital health applications in mental health, an electronic MBI on maternal mental health during pregnancy was implemented and assessed in terms of transferability to standard care in Germany. The present study focused the health economic outcomes of the randomized controlled trial (RCT)., Methods: The analysis, adopting a payer's and a societal perspective, included women of increased emotional distress at < 29 weeks of gestation. We applied inferential statistics (α = 0.05 significance level) to compare the intervention group (IG) and control group (CG) in terms of HCRU and costs. The analysis was primarily based on statutory health insurance claims data which covered the individual observational period of 40 weeks., Results: Overall, 258 women (IG: 117, CG: 141) were included in the health economic analysis. The results on total health care costs from a payer's perspective indicated higher costs for the IGi compared to the CG (Exp(ß) = 1.096, 95% CI: 1.006-1.194, p = 0.037). However, the estimation was not significant after Bonferroni correction (p < 0.006). Even the analysis from a societal perspective as well as sensitivity analyses did not show significant results., Conclusions: In the present study, the eMBI did neither reduced nor significantly increased health care costs. Further research is needed to generate robust evidence on eMBIs for women suffering from peripartum depression and anxiety., Trial Registration: German Clinical Trials Register: DRKS00017210. Registered on 13 January 2020. Retrospectively registered., (© 2024. The Author(s).)

Background: Medication errors and associated adverse drug events (ADE) are a major cause of morbidity and mortality worldwide. In recent years, the prevention of medication errors has become a high priority in healthcare systems. In order to improve medication safety, computerized Clinical Decision Support Systems (CDSS) are increasingly being integrated into the medication process. Accordingly, a growing number of studies have investigated the medication safety-related effectiveness of CDSS. However, the outcome measures used are heterogeneous, leading to unclear evidence. The primary aim of this study is to summarize and categorize the outcomes used in interventional studies evaluating the effects of CDSS on medication safety in primary and long-term care., Methods: We systematically searched PubMed, Embase, CINAHL, and Cochrane Library for interventional studies evaluating the effects of CDSS targeting medication safety and patient-related outcomes. We extracted methodological characteristics, outcomes and empirical findings from the included studies. Outcomes were assigned to three main categories: process-related, harm-related, and cost-related. Risk of bias was assessed using the Evidence Project risk of bias tool., Results: Thirty-two studies met the inclusion criteria. Almost all studies (n = 31) used process-related outcomes, followed by harm-related outcomes (n = 11). Only three studies used cost-related outcomes. Most studies used outcomes from only one category and no study used outcomes from all three categories. The definition and operationalization of outcomes varied widely between the included studies, even within outcome categories. Overall, evidence on CDSS effectiveness was mixed. A significant intervention effect was demonstrated by nine of fifteen studies with process-related primary outcomes (60%) but only one out of five studies with harm-related primary outcomes (20%). The included studies faced a number of methodological problems that limit the comparability and generalizability of their results., Conclusions: Evidence on the effectiveness of CDSS is currently inconclusive due in part to inconsistent outcome definitions and methodological problems in the literature. Additional high-quality studies are therefore needed to provide a comprehensive account of CDSS effectiveness. These studies should follow established methodological guidelines and recommendations and use a comprehensive set of harm-, process- and cost-related outcomes with agreed-upon and consistent definitions., Prospero Registration: CRD42023464746., (© 2024. The Author(s).)

As one of the most frequently diagnosed mental disorders in children and adolescents with sometimes serious individual, family and social consequences, attention deficit/hyperactivity disorder (ADHD) is highly relevant to society and health policy. In Germany, data from statutory health insurance companies has reported increasing ADHD diagnosis prevalence rates over years, while epidemiological data has shown constant and recently even decreasing prevalence rates. The clinical validity of diagnoses from either data sources is unknown. In the framework of the consortium project INTEGRATE-ADHD, 5461 parents of children aged 0 to 17 years with a confirmed administrative ADHD diagnosis insured with the third-largest German statutory health insurance provider (DAK-Gesundheit) in at least one quarter of 2020 were surveyed with the questionnaires from the epidemiological German Health Interview and Examination Survey (KiGGS study) and its in-depth module on child mental health (BELLA study) on their child's ADHD diagnosis and symptoms and on other topics, including comorbidity, utilisation of healthcare services, quality of care and satisfaction, psychosocial risk and protective factors and health-related quality of life. In addition, a subsample of 202 children and adolescents with a clinical diagnosis based on the AMWF S3 guideline on ADHD was analysed. An important aim of the project is to use data linkage on person-level to identify possible causes for the often divergent prevalence estimates from epidemiological and administrative data and to integrate and validate the data sources using a guideline-based clinical diagnosis, thereby contributing to a more accurate population-based prevalence estimate of ADHD in children and adolescents and clarifying actual or supposed contradictions between the data sources. The INTEGRATE-ADHD data linkage project combines administrative, epidemiological and clinical ADHD diagnosis data to create a "three-dimensional view" of the ADHD diagnosis. The results will be used to identify fields of action for healthcare policy and self-administration in the German healthcare system and to derive recommendations for the actors and stakeholders in the field of ADHD. The first results will be published in 2024., Competing Interests: Peter Heuschmann gibt für die vergangenen 36 Monate folgende Forschungsförderungen und Verträge mit Organisationen und Einrichtungen an: Bundesministerium für Bildung und Forschung, Europäische Union, Deutsche Parkinson Gesellschaft, Universitätsklinikum Würzburg, Deutsche Herzstiftung, Gemeinsamer Bundesausschuss (G-BA), Deutsche Forschungsgemeinschaft (DFG), Freistaat Bayern, Deutsche Krebshilfe, Charité – Universitätsmedizin Berlin (im Rahmen des MonDAFIS Projektes unterstützt durch einen uneingeschränkten Forschungszuschuss an die Charité von Bayer), Universität Göttingen (im Rahmen von FIND-AFRANDOMISED; unterstützt durch einen uneingeschränkten Forschungszuschuss an die Universität Göttingen von Boehringer-Ingelheim), Universitätsklinikum Heidelberg (im Rahmen von RASUNOA-prime; unterstützt durch einen uneingeschränkten Forschungszuschuss an das Universitätsklinikum Heidelberg von Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo).Marcel Romanos ist Vorstandsmitglied der nationalen Selbsthilfeorganisation ADHS Deutschland e.V.Alle anderen Autorinnen und Autoren geben an, dass kein Interessenkonflikt besteht.Die Partzipation von ADHS-Betroffenen wurde durch Einbeziehung des Selbsthilfeverbands ADHS Deutschland e.V. realisiert, der die Studie mit einem Letter of Intent unterstützt, seine Mitglieder über die Studie informierte und auf den in den Anschreiben für die Rekrutierung der Studienteilnehmenden Bezug genommen wurde., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Purpose of Study: In terms of continuous and coordinated health care, cross-sectoral care structures are crucial. However, the German health care system is characterized by fragmentation of medical services and responsibilities. This fragmentation leads to multiple interfaces frequently causing loss of information, effectiveness, and quality. The concept of case management has the potential to improve cooperation between sectors and health care providers. Hence, a case management intervention for patients with stroke was evaluated with an acceptance analysis on the physicians' willingness to cooperate with stroke managers and their assessment of the potential of case management for the health care of patients with stroke., Primary Practice Settings: Primary practice settings included physicians working in the hospital, rehabilitation, and outpatient sectors who had actual or potential contact with a stroke case manager within the project region of East Westphalia-Lippe., Methodology and Sample: The analysis was conducted using a mixed-methods approach. Expert interviews were conducted in 2020. Afterward a questionnaire was developed, which was then distributed to physicians in 2021. Both the interviews and the questionnaire included questions on conceptual knowledge and concrete expectations prior of the project, on experiences during the project and on recommendations and physicians' assessment of future organization in health care to classify and describe the acceptance., Results: Nine interviews were conducted and 23 questionnaires were completed. Only slightly more than 50% of the physicians had prior knowledge of the case management approach. Overall, ambiguous results concerning the acceptance of case managers were revealed. Additional personal assistance for patients with stroke was seen as beneficial at the same time critical perspectives regarding further fragmentation of health care and overlapping of competences with existing professional groups or forms of health care were collected. General practitioners in particular were critical of the case management approach., Implications for Case Management Practice: From the physicians' point of view, at least two changes are necessary for the project approach to be integrated into standard care. First, the target group should be adapted according to the case management approach. Second, the delegation of tasks and responsibilities to case managers should be revised. The sectoral difference in the acceptance of case managers by physicians indicates that active cooperation and communication in everyday work has direct impact on the acceptance of a new occupational profession. Physician acceptance has a significant impact on the implementation of new treatment modalities and thus influences the overall quality of health care., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Strokes remain a leading cause of death and disability worldwide. The STROKE OWL study evaluated a novel case management approach for patients with stroke (modified Rankin Scale 0-4) or transient ischemic attack (TIA) who received support across healthcare settings and secondary prevention training from case managers for one year. The primary aim of this quasi-experimental study was a reduction in stroke recurrence. Here, we report the results of a health economic analysis of the STROKE OWL study, conducted in accordance with CHEERS guidelines. The calculations were based on claims data of cooperating statutory health insurance companies. In addition to a regression analysis for cost comparison, the incremental cost-effectiveness ratio was determined, and a probabilistic sensitivity analysis was carried out. In total, 1167 patients per group were included in the analysis. The intervention group incurred 32.3% higher direct costs ( p < 0.001) than the control group. With a difference of EUR 1384.78 (95% CI: [1.2384-1.4143], p < 0.0001) and a 5.32% increase in hazards for the intervention group (HR = 1.0532, 95% CI: [0.7869-1.4096], p = 0.7274) resulting in an ICER of EUR 260.30, we found that the case management intervention dominated in the total stroke population, even for an arbitrarily high willingness to pay. In the TIA subgroup, however, the intervention was cost-effective even for a low willingness to pay. Our results are limited by small samples for both TIA and severe stroke patients and by claims data heterogeneity for some cost components, which had to be excluded from the analysis. Future research should investigate the cost-effectiveness of case management interventions for both severe stroke and TIA populations using appropriate data.

Background: Stroke has evolved to become a chronic disease and a major public health challenge. To adequately capture the full disease burden of stroke patients, the assessment of health-related quality of life (HRQoL) and thus the performance of respective measures is increasingly relevant. The aim of this analysis was to compare the measurement properties of two self-report instruments, the EQ-5D-5L and the Stroke Impact Scale 2.0., Methods: The data used for the analysis was derived from a quasi-experimental case management study for mildly to moderately affected incident stroke and transient ischemic attack (TIA) patients aged ≥ 18 in Germany. Data was collected patient-individually at 3, 6 and 12 months after initial stroke. The EQ-5D-5L and SIS 2.0 were compared in terms of feasibility, ceiling and floor effects, responsiveness and known-groups validity (Kruskal-Wallis H and Wilcoxon rank-sum test)., Results: A response for all three follow-ups is available for n = 855 patients. The feasibility of the EQ-5D-5L is determined as good (completion rate: 96.4-96.6%, ≥ one item missing: 3.2 - 3.3%), whereas the SIS 2.0 is moderately feasible (overall completion rate: 44.9-46.1%, ≥ one item missing in domains: 4.7 - 28.7%). The SIS 2.0 shows substantial ceiling effects in comparable domains (physical function: 10.4 - 13%, others: 3.5-31.3%) which are mainly larger than ceiling effects in the EQ-5D-5L index (17.1-21.5%). In terms of responsiveness, the EQ-5D-5L shows small to moderate change while the SIS 2.0 presents with moderate to large responsiveness. The EQ-5D-5L index, mobility, usual activities and Visual Analogue Scale show known-groups validity (p < 0.05). Content-related domains of the SIS 2.0 show known-groups validity as well (p < 0.05). However, it is compromised in the emotion domain in both measures (p > 0.05)., Conclusions: The EQ-5D-5L seems to be slightly more suitable for this cohort. Nonetheless, the results of both measures indicate limited suitability for TIA patients. Large-scale studies concerning responsiveness and known-groups validity are encouraged., Trial Registration: The study was registered in the German Clinical Trials Register, retrospective registration on 21.09.2022., Registration Id: DRKS00030297., (© 2024. The Author(s).)

Background: Patients with initial stroke or transient ischemic attack (TIA) are at high risk for further strokes, death or cardiovascular events. Even the first-ever stroke is associated with a high chance of disability and need for assistance. The risk of long-term health care demands increases with each subsequent event. Although the inpatient sector already provides a high standard of care in Germany, it can be difficult to obtain cross-sectoral aftercare. Thus, the study investigated whether a structured case management program can avoid stroke recurrences., Methods: The study was conducted with a quasi-experimental study design in three regions in North Rhine-Westphalia. Patients with first-ever stroke or TIA were eligible to participate. The intervention group was prospectively recruited and supported by a case manager during a one-year follow-up. Optimal Full Matching was used to generate a control group based on statutory claims data. The primary outcome was the stroke recurrence. Recurrence and mortality were analysed by using Cox regression; other secondary outcomes were examined with test-based procedures and with logistic regressions. Additionally, subgroup analyses were performed., Results: From June 2018 to March 2020, 1,512 patients were enrolled in the intervention group. Claims data from 19,104 patients have been transmitted for establishing the control group. After the matching process, 1,167 patients of each group were included in the analysis. 70 recurrences (6.0%) occurred in the intervention group and 67 recurrences (5.7%) in the control group. With a hazard ratio of 1.06 (95% CI: [1.42-0.69]; p=0.69), no significant effect was found for the primary outcome. With regard to the secondary outcome mortality, 36 patients in the intervention group and 46 in the control group died (3.1% vs. 3.9%). Again, there was no significant effect (HR: 0.86; 95% CI: [0.58-1.28], p=0.46)., Discussion: Based on the present findings, the case management approach for stroke patients evaluated here was unable to demonstrate an improvement in health care. Potential effects of case management might not be adequately depicted in short observation periods. Thus, future studies should consider longer observation periods., Conclusion: A panel of experts should discuss whether the core approach of case management to support cost-intensive individual cases is contrary to a broad implementation with a one-size-fits-all intervention for stroke patients. In this case, further research should focus on more specific study populations., (Copyright © 2023. Published by Elsevier GmbH.)

Purpose: The burden of herpes zoster (HZ) is substantial and numerous chronic underlying conditions are known as predisposing risk factors for HZ onset. Thus, a comprehensive study is needed to synthesize existing evidence. This study aims to comprehensively identify these risk factors., Methods: A systematic literature search was done using MEDLINE via PubMed, EMBASE and Web of Science for studies published from January 1, 2003 to January 1, 2023. A random-effects model was used to estimate pooled Odds Ratios (OR). Heterogeneity was assessed using the I 2 statistic. For sensitivity analyses basic outlier removal, leave-one-out validation and Graphic Display of Heterogeneity (GOSH) plots with different algorithms were employed to further analyze heterogeneity patterns. Finally, a multiple meta-regression was conducted., Results: Of 6392 considered records, 80 were included in the meta-analysis. 21 different conditions were identified as potential risk factors for HZ: asthma, autoimmune disorders, cancer, cardiovascular disorders, chronic heart failure (CHF), chronic obstructive pulmonary disorder (COPD), depression, diabetes, digestive disorders, endocrine and metabolic disorders, hematological disorders, HIV, inflammatory bowel disease (IBD), mental health conditions, musculoskeletal disorders, neurological disorders, psoriasis, renal disorders, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and transplantation. Transplantation was associated with the highest risk of HZ (OR = 4.51 (95% CI [1.9-10.7])). Other risk factors ranged from OR = 1.17-2.87, indicating an increased risk for all underlying conditions. Heterogeneity was substantial in all provided analyses. Sensitivity analyses showed comparable results regarding the pooled effects and heterogeneity., Conclusions: This study showed an increased risk of HZ infections for all identified factors., (© 2024. The Author(s).)

Introduction: Invasive meningococcal disease (IMD) causes significant mortality and long-term sequelae. This study assesses the potential public health impact of adolescent vaccination strategies employing MenACWY and MenC vaccines in Germany, where the existing meningococcal immunisation programme predominantly involves MenC administration in toddlers., Methods: A dynamic transmission model was developed to simulate the carriage of five meningococcal serogroup compartments (AY/B/C/W/Other) from 2019 until 2060 within 1-year age groups from 0 to 99 years of age. IMD cases were estimated based on case-carrier ratios. The model considered vaccine effectiveness against carriage acquisition and IMD., Results: The model predicts that introducing MenACWY adolescent vaccination could lead to a considerable reduction in IMD incidence, with the potential to prevent up to 65 cases per year and a cumulative total of 1467 cases by 2060. This decrease, mainly driven by herd effects, would result in a reduction of IMD incidence across all age groups, regardless of vaccination age. Furthermore, implementing MenACWY vaccination in adolescents is projected to decrease annual MenACWY-related IMD mortality by up to 64%, equating to an overall prevention of 156 IMD deaths by 2060. These protective outcomes are expected to culminate in approximately 2250 life years gained (LYG) throughout the model's projected time horizon. In contrast, the adoption of MenC vaccination in adolescents is predicted to have minimal influence on both IMD incidence and mortality, as well as on LYG., Conclusion: The results of this study demonstrate that implementing MenACWY vaccination for adolescents in Germany is likely to notably reduce IMD incidence and mortality across age groups. However, the introduction of MenC adolescent vaccination shows only limited impact. Considering the extensive healthcare resources typically required for IMD management, these findings suggest the potential for economic benefits associated with the adoption of MenACWY adolescent vaccination, warranting further cost-effectiveness analysis., (© 2024. The Author(s).)

Background: The incidence of certain vaccine-preventative diseases, such as influenza, herpes zoster and pneumococcal infection, continues to be high despite the availability of vaccines, resulting in a substantial health and economic burden on society, particularly among older adults aged ≥65 years., Methods: A cost calculator was developed to assess the cost of illness of influenza, herpes zoster and pneumococcal disease in France. Direct medical costs related to diagnosis and treatment in the older adult population in both inpatient and outpatient settings were modelled over a 1-year time horizon. Scenario analyses were conducted to determine the impact of hospitalizations on the results by considering only influenza-attributed diagnoses., Results: In France, influenza has the highest incidence, followed by herpes zoster and pneumococcal disease. Similarly, influenza poses the greatest cost burden among all older adults, while pneumococcal disease poses the greatest cost burden among those aged 65-74 years. When considering only influenza-attributed diagnoses, the number of inpatient visits and associated costs was reduced by 63% in the overall older adult population. In the low-incidence season, the number of inpatient visits and associated costs were reduced by 69%, while in the high-incidence season, the number of inpatient visits and associated costs increased by 63%., Conclusion: Influenza remains a leading vaccine-preventable disease among older adults in France, resulting in a substantial economic burden that could be prevented by increasing vaccine uptake., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Public Health Association.)