Reductions in inpatient and outpatient mental health care in germany during the first year of the COVID-19 pandemic - What can we learn for a better crisis preparedness?

BACKGROUND: During the COVID-19 pandemic, reports from several European mental health care systems hinted at important changes in utilization. So far, no study examined changes in utilization in the German mental health care inpatient and outpatient mental health care system comprehensively. METHODS: This longitudinal observational study used claims data from two major German statutory health insurances, AOK PLUS and BKK, covering 162,905 inpatients and 2,131,186 outpatients with mental disorders nationwide. We analyzed changes in inpatient and outpatient mental health service utilization over the course of the first two lockdown phases (LDPs) of the pandemic in 2020 compared to a pre-COVID-19 reference period dating from March 2019 to February 2020 using a time series forecast model. RESULTS: We observed significant decreases in the number of inpatient hospital admissions by 24-28% compared to the reference period. Day clinic admissions were even further reduced by 44-61%. Length of stay was significantly decreased for day clinic care but not for inpatient care. In the outpatient sector, the data showed a significant reduction in the number of incident outpatient diagnoses. CONCLUSION: Indirect evidence regarding the consequences of the reductions in both the inpatient and outpatient sector of care described in this study is ambiguous and direct evidence on treatment outcomes and quality of trans-sectoral mental healthcare is sparse. In line with WHO and OECD we propose a comprehensive mental health system surveillance to prepare for a better oversight and thereby a better resilience during future global major disruptions.

Prevalence of obesity and cardiovascular disease in adults with type 2 diabetes and use of diabetes medication in Germany: A claims data study.

AIMS: To identify the prevalence of cardiovascular disease (CVD) and obesity in patients with type 2 diabetes (T2D) in Germany and to evaluate if antidiabetic treatment patterns varied by comorbidity status. MATERIALS AND METHODS: Patients with T2D (aged ≥18 years) were identified during the study period (2014-2020) from medical claims of 4.5 million publicly insured German residents and divided into different cohorts based on CVD and/or obesity diagnosis. Annual prevalence and incidence were estimated for each study year, while characteristics and treatments were assessed in 2020. Data were extrapolated to the German population by age and sex. RESULTS: The prevalence of T2D in 2020 was 11.4%. Among patients with T2D, 53.0% had CVD, 39.3% had obesity, and 20.9% had CVD and obesity. Since 2014, CVD increased by 1.4%, obesity by 4.5%, and CVD with obesity by 2.7% in patients with T2D. The incidence of T2D in 2020 was 1.0% (42.9% had CVD, 37.9% had obesity, and 15.8% had CVD and obesity). Among the prevalent T2D population in 2020, 4.9% received glucagon-like peptide-1 receptor agonists (GLP-1RAs), 9.7% received sodium-glucose cotransporter-2 (SGLT2) inhibitors, and 13.0% received GLP-1 RAs and/or SGLT2 inhibitors. Of those with CVD, 12.9% received GLP-1 RAs and/or SGLT2 inhibitors (without CVD, 13.2%). Of those with obesity, 19.4% received GLP-1RAs and/or SGLT2 inhibitors (without obesity, 9.0%). CONCLUSIONS: In this retrospective claims database study, more than two thirds of patients with T2D also had CVD, obesity, or both CVD and obesity. GLP-1 RA and SGLT2 inhibitor use remained low.

Effect evaluation of outpatient long-term video EEGs for people with seizure disorders - study protocol of the ALVEEG project: a randomized controlled trial in Germany.

BACKGROUND: Epilepsy and other seizure disorders account for a high disease burden in Germany. As a timely diagnosis and accurate treatment are crucial, improving the management of these disorders is important. Outside of Germany, outpatient long-term video EEGs (ALVEEGs) have demonstrated the potential to support the diagnosis and management of epilepsy and other seizure disorders. This study aims to evaluate the implementation of ALVEEGs as a new diagnostic pathway in eastern parts of Germany to diagnose epilepsy and other seizure disorders and to assess if ALVEEGs are equally effective as the current inpatient-monitoring gold standard, which is currently only available at a limited number of specialized centers in Germany. METHODS: ALVEEG is a prospective, multicenter, randomized controlled equivalence trial, involving five epilepsy centers in the eastern states of Germany. Patients will be randomized into either intervention (IG) or control group (CG), using a permuted block randomization. The sample size targeted is 688 patients, continuously recruited over the trial. The IG will complete an ALVEEG in a home setting, including getting access to a smartphone app to document seizure activity. The CG will receive care as usual, i.e., inpatient long-term video-EEG monitoring. The primary outcome is the proportion of clinical questions being solved in the IG compared to the CG. Secondary outcomes include hospital stays, time until video EEG, time until diagnosis and result discussion, patients' health status, quality of life and health competence, and number and form of epilepsy-related events and epileptiform activity. Alongside the trial, a process implementation and health economic evaluation will be conducted. DISCUSSION: The extensive evaluation of this study, including an implementation and health economic evaluation, will provide valuable information for health policy decision-makers to optimize future delivery of neurological care to patients affected by epilepsy and other seizure disorders and on the uptake of ALVEEG into standard care in Germany. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023.

Identifying Predictors of Heart Failure Readmission in Patients From a Statutory Health Insurance Database: Retrospective Machine Learning Study.

BACKGROUND: Patients with heart failure (HF) are the most commonly readmitted group of adult patients in Germany. Most patients with HF are readmitted for noncardiovascular reasons. Understanding the relevance of HF management outside the hospital setting is critical to understanding HF and factors that lead to readmission. Application of machine learning (ML) on data from statutory health insurance (SHI) allows the evaluation of large longitudinal data sets representative of the general population to support clinical decision-making. OBJECTIVE: This study aims to evaluate the ability of ML methods to predict 1-year all-cause and HF-specific readmission after initial HF-related admission of patients with HF in outpatient SHI data and identify important predictors. METHODS: We identified individuals with HF using outpatient data from 2012 to 2018 from the AOK Baden-Württemberg SHI in Germany. We then trained and applied regression and ML algorithms to predict the first all-cause and HF-specific readmission in the year after the first admission for HF. We fitted a random forest, an elastic net, a stepwise regression, and a logistic regression to predict readmission by using diagnosis codes, drug exposures, demographics (age, sex, nationality, and type of coverage within SHI), degree of rurality for residence, and participation in disease management programs for common chronic conditions (diabetes mellitus type 1 and 2, breast cancer, chronic obstructive pulmonary disease, and coronary heart disease). We then evaluated the predictors of HF readmission according to their importance and direction to predict readmission. RESULTS: Our final data set consisted of 97,529 individuals with HF, and 78,044 (80%) were readmitted within the observation period. Of the tested modeling approaches, the random forest approach best predicted 1-year all-cause and HF-specific readmission with a C-statistic of 0.68 and 0.69, respectively. Important predictors for 1-year all-cause readmission included prescription of pantoprazole, chronic obstructive pulmonary disease, atherosclerosis, sex, rurality, and participation in disease management programs for type 2 diabetes mellitus and coronary heart disease. Relevant features for HF-specific readmission included a large number of canonical HF comorbidities. CONCLUSIONS: While many of the predictors we identified were known to be relevant comorbidities for HF, we also uncovered several novel associations. Disease management programs have widely been shown to be effective at managing chronic disease; however, our results indicate that in the short term they may be useful for targeting patients with HF with comorbidity at increased risk of readmission. Our results also show that living in a more rural location increases the risk of readmission. Overall, factors beyond comorbid disease were relevant for risk of HF readmission. This finding may impact how outpatient physicians identify and monitor patients at risk of HF readmission.

[State-organized healthcare instead of patient-organized?] / Staatsmedizin statt Selbstverwaltung?

The previous concept of self-administration as a regulatory body in healthcare in Germany has been repeatedly called into question by politicians. Different approaches can be recognized in various examples. In the author's view, healthcare provision based on legal ordinances and action geared towards legislative periods cannot replace the solutions found by self-administration-neither in terms of content, expertise nor quality. It is precisely the separation of roles and responsibilities between the state and self-administration that has so far ensured that decisions are made close to the healthcare system in order to further develop the healthcare system in Germany based on evidence and without losing sight of the costs.

[The population perspective in assessing the performance of Germany's health care system: Results of a cross-sectional survey among members of a statutory health insurance]. / Die Bevölkerungsperspektive in der Bewertung der Leistungsfähigkeit des deutschen Gesundheitssystems: Ergebnisse einer Querschnittsbefragung GKV-Versicherter.

INTRODUCTION: Since the World Health Report in 2000, Health System Performance Assessment (HSPA) has been established as a tool for the evaluation and evidence-informed governance of health systems. So far, the population perspective has not been integrated into HSPA in a systematic manner, although people's experiences and expectations are of great importance to improve health systems and especially to strengthen patient-centered care. Therefore, this study aims to conduct an HSPA of Germany's health system from the population's perspective covering all eight goals of WHO's Health Systems Framework, and to identify strengths and needs for improvement. METHODS: In 2018, 32,000 people insured with the German sickness fund 'AOK Nordost' were invited by mail to participate in the survey. The questionnaire contained a total of 43 items covering the eight goals of WHO's Health Systems Framework (e.g., access, quality, safety) plus socioeconomics and other characteristics of the insured persons. The data on the health system goals were analyzed descriptively and by subgroups (age, sex, income, chronic conditions, health literacy). RESULTS: The sample (n=1,481; response rate 4.6%) was 54.8% female and had a mean age of 59.1 years (±18.5). Altogether, the participants saw several needs for improvement within the German health system. For instance, 60.0% found quality differences between hospitals to be big, and between 3.9% and 8.5% reported mistakes related to their treatment or prescription medication in the previous two years. A big need for reform was especially seen regarding out-of-pocket payments (51.5%) and the coordination of ambulatory care physicians among each other (44.2%) and with hospitals (41.9%). In addition, big subgroup differences were seen, especially for income and health literacy. Of the participants in the lower income group, 37.2% reported a (very) strong financial burden due to out-of-pocket payments (vs. 20.7%). People with limited health literacy (52.1%) assessed the access to care generally as not being good, and they perceived greater quality differences and needs for reform, compared to their counterparts. For instance, 36.6% had experienced discrimination in the previous year (vs. 19.9%). DISCUSSION: The survey results provide a comprehensive picture of Germany's health system from the population perspective. In some areas, previous findings were confirmed (e.g., a lack of coordination between providers). Other results expand existing knowledge (e.g., the role of health literacy in health care provision) or raise new questions (e.g., the difference between the subjectively assessed burden from out-of-pocket payments and the objective measures currently used). The great differences between subgroups are a call to action on the level of both politics and practice to better consider the individual's needs in order to make health better for everyone. Further research could provide deeper insights in this regard. CONCLUSION: Strengthening the population perspective in HSPA allows for a better understanding and evaluation of health systems and, in particular, helps to identify areas for improvement in patient-centered care.

End-of-life care in Germany between 2016 and 2020 - A repeated cross-sectional analysis of statutory health insurance data.

BACKGROUND: The Hospice and Palliative Care Act of 2015 aimed at developing and regulating the provision of palliative care (PC) services in Germany. As a result of the legal changes, people with incurable diseases should be enabled to experience their final stage of life including death according to their own wishes. However, it remains unknown whether the act has impacted end-of-life care (EoLC) in Germany. OBJECTIVE: The present study examined trends in EoLC indicators for patients who died between 2016 and 2020, in the context of Lower Saxony, Germany. METHODS: Repeated cross-sectional analysis was conducted on data from the statutory health insurance fund AOK Lower Saxony (AOK-LS), referring to the years 2016-2020. EoLC indicators were: (1) the number of patients receiving any form of outpatient PC, (2) the number of patients receiving generalist outpatient PC and (3) specialist outpatient PC in the last year of life, (4) the onset of generalist outpatient PC and (5) the onset of specialist outpatient PC before death, (6) the number of hospitalisations in the 6 months prior to death and (7) the number of days spent in hospital in the 6 months prior to death. Data for each year were analysed descriptively and a comparison between 2016 and 2020 was carried out using t-tests and chi-square tests. RESULTS: Data from 160,927 deceased AOK-LS members were analysed. The number of patients receiving outpatient PC remained almost consistent over time (2016 vs. 2020 p = .077). The number of patients receiving generalist outpatient PC decreased from 28.4% (2016) to 24.5% (2020; p < .001), whereas the number of patients receiving specialist outpatient PC increased from 8.5% (2016) to 11.2% (2020; p < .001). The onset of generalist outpatient PC moved from 106 (2016) to 93 days (2020; p < .001) before death, on average. The onset of specialist outpatient PC showed the reverse pattern (2016: 55 days before death; 2020: 59 days before death; p = .041). CONCLUSION: Despite growing needs for PC at the end of life, the number of patients receiving outpatient PC did not increase between 2016 and 2020. Furthermore, specialist outpatient PC is being increasingly prescribed over generalist outpatient PC. Although the early initiation of outpatient PC has been proven valuable for the majority of people at the end of life, generalist outpatient PC was not initiated earlier in the disease trajectory over the study period, as was found to be true for specialist outpatient PC. Future studies should seek to determine how existing PC needs can be optimally met within the outpatient sector and identify factors that can support the earlier initiation of especially generalist outpatient PC. TRIAL REGISTRATION: The study "Optimal Care at the End of Life" was registered in the German Clinical Trials Register (DRKS00015108; 22 January 2019).

[Reference evaluations for estimating prevalence, incidence, and mortality of public health relevant diseases based on routine data]. / Referenzauswertungen für die Schätzung von Prävalenz, Inzidenz und Mortalität Public-Health-relevanter Erkrankungen auf Basis von Routinedaten.

The routine data of all statutorily insured persons according to the Data Transparency Regulation (DaTraV data) represent a promising data source for the recurrent and timely surveillance of non-communicable diseases (NCDs) in Germany. Thereby, it has become apparent that there is a high demand for reference evaluations that enable quick and regularly repeatable analyses on important NCDs. Against this background, ReFern-01 was initiated, a joint project of the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM). In collaboration with experts from the field of secondary data analysis and healthcare research, reference evaluations for estimating prevalence, incidence, and mortality for important public health-relevant diseases were developed. First, 11 central NCDs were selected by means of an online survey, and initial case definitions were created in conjunction with a literature review. These were then discussed and agreed upon in a virtual workshop. The created reference evaluations (analysis scripts) allow a standardized estimation of the mentioned epidemiological figures, which are comparable over time and regionally. In addition to providing the results, the scripts will be available at the BfArM for further analysis. Provided that remote access to the analysis of the DaTraV data is available in the future, the results of the ReFern project can strengthen the surveillance of NCDs and support public health actors, for example, in the planning and implementation of health promotion and prevention measures at the federal, state, county, and local levels.

[Immune-mediated inflammatory diseases in Germany : A cross-sectional analysis of comorbidities and pharmacotherapy]. / Chronische Entzündungserkrankungen in Deutschland : Eine Querschnittanalyse über Begleiterkrankungen und Arzneimitteleinsatz.

BACKGROUND: Immune-mediated inflammatory diseases (IMID) can lead to a substantial disease burden for those affected, in particular by the concomitant occurrence of other IMIDs or in the presence of comorbidities. The care of patients with IMIDs is complex and involves various medical disciplines. OBJECTIVE: To describe the burden of disease and the current routine drug treatment of patients with IMID. MATERIAL AND METHODS: The retrospective cross-sectional analysis was based on statutory health insurance claims data from the InGef database. Prevalent patients with psoriasis (Pso), psoriatic arthritis (PsA), spondylarthritis (SpA), rheumatoid arthritis (RA), Crohn's disease (MC), ulcerative colitis (CU), or connective tissue disease were identified among 3,988,695 insured patients in 2018. The concomitant occurrence of different IMIDs and the extent to which patients with IMID are affected by other comorbidities compared to a reference population were investigated. The current routine drug treatment was described based on the use of predefined forms of treatment. RESULTS: In the database 188,440 patients with IMID (4.7%) were identified. Compared to the reference population the prevalence of comorbidities, such as depressive episodes and cardiovascular risk factors was higher in patients with IMID. For MC, CU, RA, and PsA disease-modifying antirheumatic drugs (DMARD) and classical systemic forms of treatment were used most commonly. In Pso, SpA, and connective tissue disease nonsteroidal anti-inflammatory drugs (NSAID) were the most frequently used treatment often in combination with other drugs. CONCLUSION: A considerable number of patients with IMIDs (16.9-27.5%) suffer from different diseases of the IMID group. They are frequently affected by accompanying illnesses and require interdisciplinary medical treatment.

Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany.

Context: Digital health applications that support patients in managing their condition can have a positive impact on patients' health and improve the overall care process. In late 2019, as the first country worldwide, Germany included digital health applications in the benefit basket of the statutory health insurance (SHI) system to enable fast, broad-scale patient access and encourage innovation in the digital health industry. While the policy is widely recognized as a pioneering step toward improving patient care through digital technologies, there are concerns regarding the mechanics of the policy and the resulting financial risks for the SHI system. Goals: The primary objective of this article is to provide a comprehensive and balanced overview of the German policy by evaluating its success in achieving its goals and by reviewing challenges that have emerged. The secondary objective is to delineate prospective policy options and areas warranting future research. Approach: The article analyzes publicly available data of the Federal Institute for Drugs and Medical Devices collected between February 1st and July 17th, 2023, and complements it with empirical findings published by academic institutions and sickness funds. It discusses policy options and related areas of future research to overcome the identified challenges without jeopardizing the purpose of the legislation to encourage innovation in the digital health industry to improve patient care. Conclusion: In line with the goals of the reimbursement policy, the inclusion of digital health applications in the SHI benefit basked has entailed new digital treatment options for patients across multiple disease areas. However, from a health policy perspective, the policy has several shortcomings, including low prescription rates, the temporary reimbursement of digital health applications that lack proven benefit, and a pricing framework that does not take into account the efficacy and efficiency of a treatment and may lead to a suboptimal allocation of public resources. Rather than the public system covering digital health applications without proven benefit, the authors suggest giving SHI organizations more budget authority to directly incentivize research and development activities and to introduce value-based pricing. More research is needed to determine the details of these mechanisms.

Protocol for an economic evaluation of a tele-neurologic intervention alongside a stepped wedge randomised controlled trial (NeTKoH).

BACKGROUND: A significant and growing portion of the global burden of diseases is caused by neurological disorders. Tele-neurology has the potential to improve access to health care services and the quality of care, particularly in rural and underserved areas. The economic evaluation of the stepped wedge randomised controlled trial NeTKoH aims to ascertain the cost-effectiveness and cost-utility regarding the effects of a tele-neurologic intervention in primary care in a rural area in Germany. METHODS: This protocol outlines the methods used when conducting the trial-based economic evaluation of NeTKoH. The outcomes used in our economic analysis are all prespecified endpoints of the NeTKoH trial. Outcomes considered for the cost-utility and cost-effectiveness analyses will be quality-adjusted life years (QALYs) derived from the EQ-5D-5L, proportion of neurologic problems being solved at the GP's office (primary outcome), hospital length-of-stay and number of hospital stays. Costs will be prospectively collected during the trial by the participating statutory health insurances, and will be analysed from a statutory health insurance perspective within the German health care system. This economic evaluation will be reported complying with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. DISCUSSION: This within-trial economic evaluation relaying the costs and outcomes of an interdisciplinary tele-consulting intervention will provide high-quality evidence for cost-effectiveness and policy implications of a tele-neurological programme, including the potential for application in other rural areas in Germany or other jurisdictions with a comparable health system. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00024492), date registered: September 28, 2021.

[Psychotherapeutic appointments given by Associations of Statutory Health Insurance Physicians in 2019 : An analysis differentiated by appointment type and region]. / Vermittlung der Terminservicestellen Psychotherapie im Jahr 2019 : Eine Auswertung differenziert nach Vermittlungsanliegen und KV-Region.

BACKGROUND: One provision of the Care Provision Strengthening Act in Germany was that psychotherapeutic appointments (psychotherapeutic consultation, acute care, and probatory sessions) are now arranged through the Association of Statutory Health Insurance Physicians organizations. We examined how many appointments were requested and given in 2019, differentiated by appointment type and by city state versus areal state organizations. METHODS: The frequency of requests and appointments made in 2019 were collected from the Association of Statutory Health Insurance Physicians organizations in Germany using a questionnaire. Statistical analysis comprised descriptive evaluations and a Kruskal-Wallis test. RESULTS: Data for appointments were available from 17 and information on requests from 16 Association of Statutory Health Insurance Physicians organizations. A total of 134,578 appointments were given. The number of granted appointments ranged from 193 to 21,810, revealing substantial differences between the individual organizations. The share of psychotherapeutic consultations among all psychotherapeutic appointments granted amounted to a median of 92%. Per organization, appointments were given for a median of 87% of requests for a psychotherapeutic consultation (range 56-100%), 96% for acute care requests (range 29-100%), and 97% for probatory session requests (range 27-100%) (n = 16, respectively). There were minor differences between city states and areal states in granting acute care and probatory sessions. DISCUSSION: There are deficits both in city state and areal state Association of Statutory Health Insurance Physicians organizations in terms of granting acute care and probatory sessions. Our results do not allow conclusions about distance to the practices or waiting times.

Ten years of German benefit assessment: price analysis for drugs with unproven additional benefit.

INTRODUCTION: Since 2011, the prices for all new drugs in Germany are negotiated based on a benefit assessment. The purpose of this study was to analyze the price regulation of drugs with unproven additional benefit. METHODS: Benefit assessment procedures from 2011 to 2020 were reviewed and selected through AMNOG Monitor and Lauer Taxe. Negotiated annual therapy costs, the annual costs of the most cost-efficient appropriate comparative therapy (ACT) and the potential budget impact for 33 included procedures were calculated. RESULTS: 55% of the included drugs achieved a negotiated price higher than the most cost-efficient ACT, 3% were identified as equal and 42% showed lower negotiated prices. The potential savings exceeded expenditures by around EUR 523.5 m. After price flexibility was adopted by the legislator in 2017, the overall potential savings still outweighed the expenditures by around EUR 62 m. CONCLUSIONS: Our analysis shows that making price negotiations more flexible by law does not undermine the fundamental aim of the AMNOG, which is to avoid additional expenditure without increased patient benefit. The regulation can thus fulfill the objective provided by the legislature of keeping drugs without proven additional benefits in the German healthcare system.

[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]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

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.

Policy as a strategy to innovate in health care? A content analysis of innovation policies in Germany, 1994-2017.

Determining what innovation means for healthcare is becoming increasingly complex. Health policy addresses this challenge by designing initiatives to improve healthcare quality and efficiency, one example being the German Innovation Fund of 2015. We investigate the innovation concept underlying 25 years of German health policy to analyse which and why some innovations are sustainable in a healthcare system. Expanding a previous approach to identify changes in the semantic understanding of 'innovation', we identify the semantic understandings of innovation, variation in health innovation policy contingencies. We use Henry Mintzberg's approach to classify patterns in health innovation policy to uncover predominant planning, adaptive, and entrepreneurial strategy modes. Systematic analysis resulted in 44 decision-relevant policy documents. Content was classified based on a qualitative content structuring method according to seven main categories and 57 subcategories. Results reveal that the innovation concept is undergoing a transformation from a science-based concept, dominated by planning and adaptive modes, towards an exploration of process innovations, dominated by adaptive and entrepreneurial strategy modes. This change in strategy is an essential contingency of high-volume instruments, such as the Innovation Fund, and their capability to support the emergence of process innovations that lead to structural changes in the healthcare system.

[Utilization of routine data from different statutory health insurance funds: a practical report of experience from the TIM-HF2 study about data acquisition, validation, and processing]. / Nutzung von Routinedaten unterschiedlicher gesetzlicher Krankenkassen: Ein Erfahrungsbericht aus der TIM-HF2-Studie zur Datenerschließung, -validierung und -aufbereitung.

BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.

The effectiveness of additional screening examinations for children and adolescents in Germany: a longitudinal retrospective cohort study.

BACKGROUND: Continuous medical care is particularly important in childhood and adolescence. Since there are gaps in regular care in Germany, various health insurance providers offer to cover additional examinations (e.g., U10, U11, J2) to ensure ongoing paediatrician visits. However, the question arises as to whether these examinations are effective. Thus, the main objective of this study is to determine whether participation in the U10, U11 or J2 examinations leads to more frequent and earlier diagnosis and treatment of age-specific diseases. METHODS: The analyses are based on administrative claims data from a statutory health insurance fund. For each examination, an intervention group (IG) is formed and matched with a corresponding control group (CG). Descriptive analyses include proportion with diagnosis and treatment, average age of diagnosis and treatment initiation. Hypothesis testing is performed using methods appropriate to each. In addition, subgroup analyses and binominal logistic regression models are conducted. RESULTS: More diagnoses are detected in IG, irrespective of subgroups. Additionally, diagnoses are made slightly earlier on average in IG. In the total samples, more therapies are initiated in IG, and slightly earlier. Considering only diagnosed cases, more therapies are initiated in CG but continue to be started earlier in IG. Regression models show that participation in the examinations has the highest predictive power for detecting a diagnosis. The presence of a chronic disease and sex - male at the U10 and U11 and female at the J2 - are also significantly associated. The models further show that nationality, unemployment of parents and region also have a significant influence in some cases, whereas school-leaving qualification, vocational qualification and income of parents do not. Considering the initiation of treatment in overall samples, the models show similar results, but here the presence of a chronic illness has the highest predictive power. CONCLUSION: The results indicate that participation in the examinations leads to significantly more diagnoses and, in the overall samples, significantly more treatments. In addition, diagnoses were made somewhat earlier and therapies were initiated somewhat earlier. In the future, it would be useful to investigate the U10, U11 and J2 examinations over a longer time horizon to determine whether the statistically significant difference found is also clinically relevant, i.e., earlier diagnosis and initiation of therapy lead to prevention of manifestation or progression of the diagnosed diseases and to avoidance of secondary diseases. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

Hemodialysis and Peritoneal Dialysis in Germany from a Health Economic View-A Propensity Score Matched Analysis.

BACKGROUND: Hemodialysis (HD) and peritoneal dialysis (PD) are deemed medically equivalent for therapy of end-stage renal disease (ESRD) and reimbursed by the German statutory health insurance (SHI). However, although the home dialysis modality PD is associated with higher patient autonomy than HD, for unknown reasons, PD uptake is low in Germany. Hence, we compared HD with PD regarding health economic outcomes, particularly costs, as potentially relevant factors for the predominance of HD. METHODS: Claims data from two German health insurance funds were analysed in a retrospective cohort study regarding the prevalence of HD and PD in 2013-2016. Propensity score matching created comparable HD and PD groups (n = 436 each). Direct annual health care costs were compared. A sensitivity analysis included a comparison of different matching techniques and consideration of transportation costs. Additionally, hospitalisation and survival were investigated using Poisson regression and Kaplan-Meier curves. RESULTS: Total direct annual average costs were higher for HD (€47,501) than for PD (€46,235), but not significantly (p = 0.557). The additional consideration of transportation costs revealed an annual cost advantage of €7000 for PD. HD and PD differed non-significantly in terms of hospitalisation and survival rates (p = 0.610/p = 0.207). CONCLUSIONS: PD has a slight non-significant cost advantage over HD, especially when considering transportation costs.

Medicinal Treatment of Elderly Psoriasis Patients before and after Entering a Nursing Home.

Psoriasis (PS) is a chronic inflammatory skin disease, and it increasingly appears also in the elderly population. There is a rising interest in drug therapy for PS, especially for people receiving care in nursing homes (NH). Which PS-related drugs are prescribed in the time before nursing home admission (NHA), and to what extent does the supply of drugs change after NHA? Which specialties prescribe PS-related drugs? Statutory health insurance data were examined for people with PS, aged ≥ 65 years, who were newly admitted to a NH in the period 2011-2014 and observed for one year before and after NHA. Changes in prescription prevalence (pre-post comparison) were examined for significant differences. Prescriptions of PS-relevant drugs were measured by defined daily dose and stratified according to the prescribing specialist group. The analysis included 718 insured persons with PS (76.2% female, mean age 83.3 years). Systemic therapeutics played a minor role (pre: 2.6% vs. post: 2.1%) in drug therapy. Topical steroids had a high share of about 40% in the pre-post comparison. Overall, the proportion of people with PS who received treatment remained at a comparable level before and after NHA. A structured assessment of the skin is crucial, specifically in people with cognitive impairment.

Secular Trends and Rural-Urban Differences in Diagnostic Prevalence of Hay Fever: A Claims-Based Study in Germany.

Purpose: We aimed to examine possible variations in diagnostic prevalence of hay fever between urban and rural regions as well as in age-specific temporal developments. Patients and Methods: We used nationwide outpatient claims data from the years 2010 to 2019. The data contain information for all individuals with statutory health insurance (SHI) in Germany who were treated at least once in respective years (n = 71,410,121 in 2019). Individuals with a confirmed diagnosis of hay fever were defined as prevalent cases. We examined the association between the degree of urbanization and age- and sex-standardized prevalence of hay fever. We used the age- and sex-structure of SHI insurees in the year 2010 as a reference population for direct standardization. Results: The standardized prevalence of hay fever increased from 6.2% in 2010 to 7.2% in 2019, corresponding to a relative increase of 16%. However, we observed a clear decrease in prevalence among children, with the strongest relative reduction in young children (0-2 years: -53%). The standardized prevalence in the total population in 2019 was lowest in rural areas with a low population density (6.6%) and highest in big urban municipalities (7.8%). In stark contrast, prevalence in 0-14-year-olds was lowest in big urban municipalities (4.3%). Conclusion: We observed a decrease in the prevalence of hay fever in children and increase in the older age groups. A clear urban-rural association observed over years may be explained by environmental factors. Deviations from this general regional pattern in children of the age group 0-14 years may be explained by differing age-specific risk factors of hay fever.