Risk factors for herpes zoster infections: a systematic review and meta-analysis unveiling common trends and heterogeneity patterns.

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 I2 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.

Comparing the EQ-5D-5L and stroke impact scale 2.0 in stroke patients: an analysis of measurement properties.

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.

Cost of illness of the vaccine-preventable diseases influenza, herpes zoster and pneumococcal disease in France.

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.

How intervention studies measure the effectiveness of medication safety-related clinical decision support systems in primary and long-term care: a systematic review.

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.

The impact of Germany's human papillomavirus immunization program on HPV-related anogenital diseases: a retrospective analysis of claims data from statutory health insurances.

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.

[INTEGRATE-ADHD: Comparison and Integration of Administrative and Epidemiological ADHD Diagnosis Data through Clinical Assessment - Presentation of the Project]. / INTEGRATE-ADHD: Vergleich und Integration administrativer und epidemiologischer ADHS-Diagnosedaten durch klinisches Assessment ­ Vorstellung des Projekts.

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.

Influence of Self-Reported Health Impairments on German EQ-5D-5L Values.

OBJECTIVES: The German EQ-5D-5L value set is based on the average preferences of the general population. Nevertheless, in Germany, there is an ongoing debate about the appropriateness of using general population preferences and whether patient preferences should be used instead. Thus, this research aimed to determine the robustness of the German EQ-5D-5L valuation data for the general population compared with those with health impairments. METHODS: Subgroups were built on the self-reported quality of life, measured with the EQ-5D-5L. To identify which groups significantly influenced the value set, different regression models, including dummy variables for the subgroups, were tested while controlling for preference heterogeneity. Backward selection based on the Akaike information criterion led to significant subgroup dummies, which were analyzed in more detail. For each significant subgroup, the value set model was estimated separately. The models were then compared. Sociodemographics of the subgroups were considered. RESULTS: Three significant dummies were identified: state 11111, severity levels 5 to 7, and self-reported problems with pain/discomfort. The value sets for the 6 subgroups were compared with the national German value set, showing only marginal deviations. The mean absolute deviation ranged from 0.004 to 0.013. No different densities were identified for the decrements of the different value sets. CONCLUSIONS: People with self-reported health impairments do not have different EQ-5D-5L health state preferences compared with the German general population. Further research is needed to determine whether the presence of a chronic health condition has a larger influence on health state valuation than the general population.

Healthcare costs of congenital cytomegalovirus (cCMV) disease in infants during the first two years of life: a retrospective German claims database analysis.

BACKGROUND: Congenital cytomegalovirus (cCMV) infection can cause severe neurological damage, growth retardation, hearing loss, and microcephaly in infants. We aimed at assessing healthcare costs of infants with recorded cCMV diagnosis in an administrative claims database in the first 2 years of life. METHODS: We conducted a retrospective, controlled cohort study using German claims data from the Institute for Applied Health Research Berlin (InGef) database. Incremental healthcare costs during the first and second year of life were assessed by matching (1:60) infants with cCMV diagnoses ≤ 90 days after birth (cCMV90 cohort) to infants without cCMV diagnosis ("representative" controls) and infants with cCMV diagnoses ≤ 21 days after birth plus specific symptoms (cCMV21-S) to infants without cCMV and any ICD-10-GM records (besides Z00-Z99) until 4th preventive health check-up ("healthy" controls). Due to missing data, mean imputation was applied for aids and remedies costs. RESULTS: We identified 54 and 24 infants born 2014-2018 for the cCMV90 and cCMV21-S cohorts, respectively. During the first year, mean (median) healthcare costs were significantly higher in cCMV90 cases vs. "representative" controls (€22,737 (€9759) vs. €3091 (€863), p < 0.001), with 87.2% inpatient costs. Healthcare costs for cCMV21-S cases compared to "healthy" controls were €34,498 (€20,924) vs. €680 (€569), p < 0.001. Differences decreased for both comparisons in the second year but remained statistically significant. CONCLUSIONS: cCMV comprises a considerable economic burden for the German healthcare system (€19,646 to €33,818 higher mean costs for infants with recorded cCMV diagnosis in the first year of life). Attempts should be made to reduce this burden.

Financial toxicity in cancer patients treated with radiotherapy in Germany-a cross-sectional study.

PURPOSE: Financial toxicity arises in cancer patients from subjective financial distress due to objective financial burden from the disease or treatment. Financial toxicity associates with worse outcomes. It has not been described in cancer patients undergoing radiotherapy in Germany and its publicly funded health system. In this context, we therefore investigated the prevalence of financial toxicity, associated risk factors, and patient preferences on communication of financial burden. METHODS: We conducted a preregistered ( https://doi.org/10.17605/OSF.IO/KH6VX ) cross-sectional study surveying patients at the end of their course of radiotherapy in two institutions. Objective financial burden was assessed by direct costs and loss of income. Financial toxicity was measured by subjective financial distress per EORTC QLQ-C30. We used Spearman's correlation and Fisher's exact test for univariate analysis, an ordinal regression for multivariate analysis. A p-value < 0.05 was considered statistically significant. RESULTS: Of the 100 patients participating in the study, 68% reported direct costs, 25% loss of income, and 31% subjective financial distress. Per univariate analysis, higher subjective financial distress was significantly associated with active employment, lower quality of life, lower household income, higher direct costs, and higher loss of income. The latter three factors remained statistically significant in the multivariate analysis. A relative majority of the patients welcomed communication regarding financial burden with their radiation oncologist. CONCLUSION: Financial toxicity is prevalent in cancer patients treated with radiotherapy in Germany. The reported risk factors may help to identify patients at risk. Future studies should validate these results and investigate interventions for financial toxicity to potentially improve outcomes.

Developing a New Generic Health and Wellbeing Measure: Psychometric Survey Results for the EQ-HWB.

OBJECTIVES: The development of measures such as the EQ-HWB (EQ Health and Wellbeing) requires selection of items. This study explored the psychometric performance of candidate items, testing their validity in patients, social carer users, and carers. METHODS: Article and online surveys that included candidate items (N = 64) were conducted in Argentina, Australia, China, Germany, United Kingdom, and the United States. Psychometric assessment on missing data, response distributions, and known group differences was undertaken. Dimensionality was explored using exploratory and confirmatory factor analysis. Poorly fitting items were identified using information functions, and the function of each response category was assessed using category characteristic curves from item response theory (IRT) models. Differential item functioning was tested across key subgroups. RESULTS: There were 4879 respondents (Argentina = 508, Australia = 514, China = 497, Germany = 502, United Kingdom = 1955, United States = 903). Where missing data were allowed, it was low (UK article survey 2.3%; US survey 0.6%). Most items had responses distributed across all levels. Most items could discriminate between groups with known health conditions with moderate to large effect sizes. Items were less able to discriminate across carers. Factor analysis found positive and negative measurement factors alongside the constructs of interest. For most of the countries apart from China, the confirmatory factor analysis model had good fit with some minor modifications. IRT indicated that most items had well-functioning response categories but there was some evidence of differential item functioning in many items. CONCLUSIONS: Items performed well in classical psychometric testing and IRT. This large 6-country collaboration provided evidence to inform item selection for the EQ-HWB measure.

Generation, Selection, and Face Validation of Items for a New Generic Measure of Quality of Life: The EQ-HWB.

OBJECTIVES: This article aims to describe the generation and selection of items (stage 2) and face validation (stage 3) of a large international (multilingual) project to develop a new generic measure, the EQ-HWB (EQ Health and Wellbeing), for use in economic evaluation across health, social care, and public health to estimate quality-adjusted life-years. METHODS: Items from commonly used generic, carer, social care, and mental health quality of life measures were mapped onto domains or subdomains identified from a literature review. Potential terms and items were reviewed and refined to ensure coverage of the construct of the domains/subdomain (stage 2). Input on the potential item pool, response options, and recall period was sought from 3 key stakeholder groups. The pool of candidate items was tested in qualitative interviews with potential future users in an international face validation study (stage 3). RESULTS: Stage 2 resulted in the generation of 687 items. Predetermined selection criteria were applied by the research team resulting in 598 items being dropped, leaving 89 items that were reviewed by key stakeholder groups. Face validation (stage 3) tested 97 draft items and 4 response scales. A total of 47 items were retained and 14 were modified, whereas 3 were added to the candidate pool of items. This resulted in a 64-item set. CONCLUSIONS: This international multiculture, multilingual study with a common methodology identified many items that performed well across all countries. These were taken to the psychometric testing along with modified and new items for the EQ-HWB.

The EQ-HWB: Overview of the Development of a Measure of Health and Wellbeing and Key Results.

OBJECTIVES: Existing measures for estimating quality-adjusted life-years are mostly limited to health-related quality of life. This article presents an overview of the development the EQ-HWB (EQ Health and Wellbeing), which is a measure that encompasses health and wellbeing. METHODS: Stages: (1) Establishing domains through reviews of the qualitative literature informed by a conceptual framework. (2) Generation and selection of items to cover the domains. (3) Face validation of these items through qualitative interviews with 168 patients, social care users, general population, and carers across 6 countries (Argentina, Australia, China, Germany, United Kingdom, United States). (4) Extensive psychometric testing of candidate items (using classical, factor analysis, and item response theory methods) on > 4000 respondents in the 6 countries. Stakeholders were consulted throughout. RESULTS: A total of 32 subdomains grouped into 7 high-level domains were identified from the qualitative literature and 97 items generated to cover them. Face validation eliminated 36 items, modified 14, and added 3. Psychometric testing of 64 items found little difference in missing data or problems with response distribution, the conceptual model was confirmed except in China, and most items performed well in the item response theory in all countries. Evidence was presented to stakeholders in 2 rounds of consultation to inform the final selection of items for the EQ-HWB (25-item) and the short version of EQ-HWB (9-items). CONCLUSIONS: EQ-HWB measures have been developed internationally for evaluating interventions in health, public health, and social care including the impact on patients, social care users, and carers.

Market access and value-based pricing of digital health applications in Germany.

In December 2019, the Digital Health Care Act ("Digitale-Versorgung-Gesetz") introduced a general entitlement to the provision and reimbursement of digital health applications (DiGA) for insured persons in the German statutory health insurance. As establishing a new digital service area within the solidarity-based insurance system implies several administrative and regulatory challenges, this paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, we provide a basic approach to deriving value-based DiGA prices.To become eligible for reimbursement, the Federal Institute for Drugs and Medical Devices evaluates the compliance of a DiGA with general requirements (e.g., safety and data protection) and its positive healthcare effects (i.e., medical benefit or improvements of care structure and processes) in a fast-track process. Manufacturers may provide evidence for the benefits of their DiGA either directly with the application for the fast-track process or generate it during a trial phase that includes temporary reimbursement. After one year of \]reimbursement, the freely-set manufacturer price is replaced by a price negotiated between the National Association of Statutory Health Insurance Funds and the manufacturer. By February 2022, 30 DiGA had successfully completed the fast-track process. 73% make use of the trial phase and have not yet proven their benefit. Given this dynamic growth of the DiGA market and the low minimum evidence standards, fair pricing remains the central point of contention. The regulatory framework makes the patient-relevant benefits of a DiGA a pricing criterion to be considered in particular. Yet, it does not indicate how the benefits of a DiGA should be translated into a reasonable price. Our evidence-based approach to value-based DiGA pricing approximates the SHI's willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA.The proposed approach can be fitted into DiGA pricing processes under the given regulatory framework and can provide objective guidance for price negotiations. However, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues related to DiGA pricing are still open. Thus, it remains to be seen to what extent DiGA prices will follow the premise of value-based pricing.

Feasibility of the EQ-5D in the elderly population: a systematic review of the literature.

PURPOSE: The EQ-5D-3L and 5L are widely used generic preference-based instruments, which are psychometrically sound with the general population, but little is known about the instruments' feasibility in the elderly. Therefore, this systematic review summarises the available literature with regard to the feasibility properties of the instruments in the elderly population. METHODS: We conducted a systematic search in PubMed, PsycInfo and EuroQol databases using pre-specified vocabulary and inclusion/exclusion criteria to identify publications until November 2020. Study characteristics and outcomes referring to the feasibility of the EQ-5D-3L and 5L in the elderly were extracted, if all study participants were at least 65+ years. RESULTS: We identified 17 studies reporting feasibility outcomes based on four criteria: missing values, completion rates, completion time and broad qualitative statements referring to the completion. Missing values per dimension ranged from 0 to 10.7%, although being mostly below 7%. The completion rate was around 90% or better, whereas the EQ VAS rating was missing from 2.3 to 25.3% of the respondents. Only two of the included studies examined the EQ-5D-5L; 15 studies reported on the EQ-5D-3L. CONCLUSION: Comparing our findings against the general population from published literature, we find that feasibility outcomes in older age groups are just below that of younger populations. Furthermore, older respondents have a higher propensity of requiring assistance or even an interviewer-based approach. Nonetheless, the reviewed literature indicates that the EQ-5D-3L still has good feasibility properties and, hence, is highly applicable in older respondents. However, further research is needed to explore feasibility properties of the EQ-5D-5L in this population.

Developing and testing a cognitive bolt-on for the EQ-5D-Y (Youth).

PURPOSE: The aim of this study was to develop and test a cognitive dimension as a bolt-on for the German version of the EQ-5D-Y (Youth). METHODS: A literature review and six focus groups with children and adolescents were used to develop the cognitive dimension for the EQ-5D-Y. In a two-phase pretest, the acceptability, feasibility and performance of this dimension were assessed (phase 1: qualitative face-to-face interviews, phase 2: standard pretest in a clinical setting). In total, 280 children and adolescents participated in this study. RESULTS: School performance, concentration, memory and learning ability represent the most important components of cognitive functioning in children and adolescents. Hence, those components were incorporated into the cognitive dimension of the EQ-5D-Y by adding four items. For children and adolescents living with a rheumatic disorder or type 1 diabetes mellitus, the EQ-5D-Y plus a cognitive bolt-on demonstrated good acceptability, feasibility and performance. The cognitive items improved the explanatory power for the EQ visual analogue scale (EQ-VAS). Factor analysis has shown that a reduction of the cognitive bolt-on into one or two item(s) is justifiable. CONCLUSION: By enhancing the EQ-5D-Y with a cognitive bolt-on, we developed an instrument that incorporates current findings on Health-Related Quality of Life (HRQoL) and is suitable for the target population. Empirical results of this study show that cognitive functioning is an important part of HRQoL assessment in children and adolescents. The inclusion of a cognitive dimension in the EQ-5D-Y improves the HRQoL measurement.

Effectiveness of a multi-component community-based care approach for older people at risk of care dependency - results of a prospective quasi-experimental study.

BACKGROUND: Due to demographic changes, the elderly population in western countries is constantly growing. As the risk of functional decline and multimorbidity increases with age, health care systems need to face the challenge of high demand for health care services and related costs. Therefore, innovative health care approaches and geriatric screenings are needed to provide individualised care. This study aims to expand the state of research by investigating the effectiveness of a multi-component care approach for the elderly in a German community setting. METHODS: A prospective, quasi-experimental study was initiated by statutory health insurance (SHI) companies. The innovative care approach includes a geriatric assessment, a case and network management as well as digital supporting tools and was implemented at the Center for Geriatrics and Gerontology (Albertinen Haus, Hamburg-Eimsbuettel). Participants of the intervention were compared to matched controls recruited in comparable urban areas. The primary outcome measure was the progression in long-term care grade during the period of observation (21 months), which was analysed on the basis of SHI claims data. Secondary endpoints were morbidity, mortality and self-reported health-related quality of life (HRQoL) measured by SF-36. RESULTS: Overall, 2,670 patients (intervention group (IG) n=873; control group (CG) n=1,797) were analysed. Logistic regression analysis showed no statistically significant difference in progression of long-term care grade between IG and CG (Odds Ratio (OR)=1.054; 95% confidence interval (CI) 0.856-1.296; p-value=0.616). Differentiated analyses indicated an initial effect, which might be attributable to the geriatric assessment. However, an adapted regression model resulted in a reversed but even non-significant effect (OR=0.945; 95% CI 0.757-1.177; p-value=0.619). While secondary analyses of long-term care grade, mortality and HRQoL did not show intervention effects, a statistically significant relative change of 0.865 (95% CI 0.780, 0.960; p-value=0.006) in morbidity indicated a potential benefit for the IG. CONCLUSIONS: The analyses did not reveal a significant effect of the community-based intervention on the primary outcome and thus we are not able to recommend a transfer into SHI standard care. Tendencies in secondary analyses need to be proved in further research. TRIAL REGISTRATION: German Clinical Trials Register, retrospective registration on February 01, 2022 ( DRKS00027866 ).

Healthcare resource utilization and costs in 23-25-year-old women with human papillomavirus (HPV) associated anogenital diseases in Germany - a retrospective analysis of statutory health insurance claims data.

BACKGROUND: Human papilloma virus (HPV) causes multiple anogenital diseases including cervical cancer and is the most common sexually transmitted infection. Healthcare resource utilization (HRU) associated with HPV-related anogenital diseases includes diagnostic and disease specific treatment regimens. A recent study showed disease burden of young women aged 23-25 years, who were the first populations eligible to receive HPV vaccination after its introduction in Germany. Cost for the German statutory health insurance (SHI) due to HPV­related anogenital diseases in this population are unknown. This study aimed at assessing HRU and costs related to HPV-associated anogenital diseases for the Germany SHI. METHODS: We used a retrospective, matched cohort design to leverage the prior identified cohort of 23-25-year-old women born between 1989-1992 diagnosed with HPV-related anogenital disease from the Institute for Applied Health Research Berlin (InGef) Research Database. German SHI claims data from 2012-2017 were analyzed. The prior identified cases were matched (direct, without replacement) to women without anogenital diseases (1:10 ratio). HRU and costs for inpatient care, outpatient care, and pharmaceutical during a 3-year observation period were determined for both cases and controls and increments between the groups were assessed. RESULTS: 2,972 women diagnosed with anogenital diseases (cases) who were matched to 29,720 women without anogenital diseases (controls). Cases had more outpatient visits (52.4 visits vs. 39.2 visits) and more cases (45.2% vs. 31.7%) were hospitalized at least once in the 3­year observation period. Most common outpatient procedures performed in cases were conization of the cervix uteri (4.4% cases; n < 5 controls), followed by other excision and destruction of diseased tissue of the cervix uteri (3.1% in cases; 0.0% in controls). Median difference in total healthcare costs of €684 (mean difference: €1,089, 95%CI: €752-1,426) suggest that HPV-related anogenital diseases were responsible for approximately €3.2 Million more healthcare costs for the identified cases in the four birth cohorts within the 3­year observation period in the InGef Research Database. Costs were mainly driven by outpatient care (41.6% of total costs). CONCLUSION: In Germany, HPV-related anogenital diseases among young women are associated with considerable HRU and financial expenditures, mostly driven by outpatient care.

An Innovative Telemedical Network to Improve Infectious Disease Management in Critically Ill Patients and Outpatients (TELnet@NRW): Stepped-Wedge Cluster Randomized Controlled Trial.

BACKGROUND: Evidence-based infectious disease and intensive care management is more relevant than ever. Medical expertise in the two disciplines is often geographically limited to university institutions. In addition, the interconnection between inpatient and outpatient care is often insufficient (eg, no shared electronic health record and no digital transfer of patient findings). OBJECTIVE: This study aims to establish and evaluate a telemedical inpatient-outpatient network based on expert teleconsultations to increase treatment quality in intensive care medicine and infectious diseases. METHODS: We performed a multicenter, stepped-wedge cluster randomized trial (February 2017 to January 2020) to establish a telemedicine inpatient-outpatient network among university hospitals, hospitals, and outpatient physicians in North Rhine-Westphalia, Germany. Patients aged ≥18 years in the intensive care unit or consulting with a physician in the outpatient setting were eligible. We provided expert knowledge from intensivists and infectious disease specialists through advanced training courses and expert teleconsultations with 24/7/365 availability on demand respectively once per week to enhance treatment quality. The primary outcome was adherence to the 10 Choosing Wisely recommendations for infectious disease management. Guideline adherence was analyzed using binary logistic regression models. RESULTS: Overall, 159,424 patients (10,585 inpatients and 148,839 outpatients) from 17 hospitals and 103 outpatient physicians were included. There was a significant increase in guideline adherence in the management of Staphylococcus aureus infections (odds ratio [OR] 4.00, 95% CI 1.83-9.20; P<.001) and in sepsis management in critically ill patients (OR 6.82, 95% CI 1.27-56.61; P=.04). There was a statistically nonsignificant decrease in sepsis-related mortality from 29% (19/66) in the control group to 23.8% (50/210) in the intervention group. Furthermore, the extension of treatment with prophylactic antibiotics after surgery was significantly less likely (OR 9.37, 95% CI 1.52-111.47; P=.04). Patients treated by outpatient physicians, who were regularly participating in expert teleconsultations, were also more likely to be treated according to guideline recommendations regarding antibiotic therapy for uncomplicated upper respiratory tract infections (OR 1.34, 95% CI 1.16-1.56; P<.001) and asymptomatic bacteriuria (OR 9.31, 95% CI 3.79-25.94; P<.001). For the other recommendations, we found no significant effects, or we had too few observations to generate models. The key limitations of our study include selection effects due to the applied on-site triage of patients as well as the limited possibilities to control for secular effects. CONCLUSIONS: Telemedicine facilitates a direct round-the-clock interaction over broad distances between intensivists or infectious disease experts and physicians who care for patients in hospitals without ready access to these experts. Expert teleconsultations increase guideline adherence and treatment quality in infectious disease and intensive care management, creating added value for critically ill patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03137589; https://clinicaltrials.gov/ct2/show/NCT03137589.

Burden of CIN2+ diagnoses and conizations in women aged 18-45 years-a retrospective secondary data analysis of German statutory health insurance claims data.

PURPOSE: High grade cervical intraepithelial neoplasia (CIN2+) may progress to cervical cancer. They may be detected by screening and are usually treated by conization. This study aimed at assessing annual proportions of screening, prevalent and incident CIN2+ diagnoses, as well as proportions of (re-)conizations during 24 months follow-up after conization in Germany. METHODS: A descriptive retrospective claims data analysis of the years 2013-2018 was conducted using the InGef Research Database. Women aged 18-45 years with CIN2+ diagnoses were identified by ICD-10-GM codes (N87.1, N87.2, D06.-, and C53.-). Cervical conizations were identified by OPS codes (5-671.0* or 5-671.1*). Screening participation was identified by EBM codes (01730, 01733, 32819 or 32820). Annual proportions were calculated as women with the respective documented codes divided by all women in the respective age group per calendar year. RESULTS: Overall annual proportions of screened women spanned from 60.01 to 61.33% between 2013 and 2018. The overall annual prevalence of CIN2+ diagnoses (regardless of screening participation) ranged from 0.72 to 0.84% between 2013 and 2018, with highest proportions observed in women aged 27-45 years. Also, CIN2+ incidence was highest in women 27-45 years. Annual proportion of women undergoing conization was 0.24% in 2013 and 0.21% in 2018. During a 24-month follow-up period after conization, 2.91% of women underwent a re-conization 3 months or later after the initial conization. CONCLUSION: This analysis demonstrates a considerable burden of CIN2+, conizations and re-conizations in Germany, especially in women aged 27-45 years. This highlights the need for intensified prevention efforts such as expanding human papillomavirus (HPV) vaccination.

[Level of Use and User Groups of Online Video Consultations in Outpatient Medical Care: Analysis of Claims Data]. / Nutzungsgrad und Nutzergruppen der Online-Videosprechstunde in der ambulanten ärztlichen Versorgung ­ Eine Routinedatenanalyse.

OBJECTIVE: Despite perceived potentials, billability as a standard service to the statutory health insurance (SHI) and various promotional measures, online video consultation has not yet established itself as a fixed component of everyday outpatient care. Longer-term quantitative studies on the degree of utilisation have been lacking so far. However, these are essential for a better understanding of diffusion processes and the effects of promotional measures. The present study represents a first step towards a continuous examination. METHODS: The utilisation of video consultations in outpatient care was examined from the beginning of their reimbursability in April 2017 until the end of 2018. In order to get an overview of the user groups, relevant physician and patient characteristics (specialist group, age, region) that can be depicted in the billing data were also investigated. RESULTS: During the 21 months of the observation period, a total of 320 video consultations were conducted, with monthly usage figures in 2018 already twice as high as in 2017. Overall, 105 insurants used at least one video consultation (average age 74.6 years; 59.8 from urban regions). Among the 30 doctors who used video consultation, 36.7% were general practitioners, representing the largest group of physicians. CONCLUSION: The study underlines the low significance of online video consultations in outpatient care in the first 21 months after their introduction. The results are in line with previous findings from short-term analyses and demoscopic studies. They also point to initial usage trends that need to be further investigated with extended observation periods and broader data bases across several more statutory insurance companies.